HPN 2023 December

HOSPITAL PROFESSIONAL NEWS IRELAND

HPN December 2023 Issue 115 Professional 100 Issue HOSPITALPROFESSIONALNEWS.IE

Ireland’s Dedicated Hospital Professional Publication

IN THIS ISSUE:

Empowering people worldwide to live healthier at every stage of life

NEWS: Concerns over Hospital Professional Mental Health Page 6 END OF YEAR REVIEW: Asthma Society of Ireland Page 17

With 1,600 people working across five sites in Ireland, Viatris provides access to medicines, develops innovative solutions and improves healthcare for patients.

CONFERENCE: European Society of Medical Oncology Page 38 CPD: Atrial Fibrillation Page 43 RESEARCH: Publication of the Latest Health Index Page 48 PROFESSIONAL 100: Ireland’s Leading Hospital Professionals Page 56

Viatris Newenham Court, Malahide Road, Dublin 17, Dublin, Ireland.

Viatris.ie Job Code: CC-2023-001 Date of Preparation: July 2023 www.viatris.ie

This Publication is for Healthcare Professionals Only

FEATURE: Non Small Cell Lung Cancer Page 90

PRESCRIBING INFORMATION CIBINQO® ▼ (ABROCITINIB)

Please refer to full Summary of Product Characteristics (SmPC) before prescribing Cibinqo®.

Presentation: Film-coated tablets containing 50 mg, 100 mg, or 200 mg abrocitinib. Each tablet contains 1.37 mg, 2.73 mg, and 5.46 mg of lactose monohydrate, respectively. Indications: For the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. Dosage: Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. Posology: The recommended starting dose is 100 mg or 200 mg once daily based on individual patient characteristics. A starting dose of 100 mg once daily is recommended for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE) and malignancy. If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily. A dose of 200 mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE and malignancy with high disease burden or for patients with an inadequate response to 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily. If disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered. The lowest effective dose for maintenance should be considered. Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks. Cibinqo can be used with or without medicated topical therapies for atopic dermatitis. Treatment initiation: TTreatment should not be initiated in patients with a platelet count < 150 × 103/mm3, an absolute lymphocyte count (ALC) < 0.5 × 103/ mm3, an absolute neutrophil count (ANC) < 1.2 × 103/mm3 or who have a haemoglobin value < 10 g/dL. Dose interruption: If a patient develops a serious infection, sepsis or opportunistic infection, dose interruption should be considered until the infection is controlled.

Interruption of dosing may be needed for management of laboratory abnormalities. Missed doses: If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case the patient should not take the missed dose. Thereafter, dosing should be resumed at the regular scheduled time. Interactions: In patients receiving dual strong inhibitors of cytochrome CYP2C19 and moderate inhibitors of CYP2C9, or strong inhibitors of CYP2C19 alone (e.g., fluvoxamine, fluconazole, fluoxetine and ticlopidine), the recommended dose of Cibinqo should be reduced by half to 100 mg or 50 mg once daily. Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g., rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin). In patients receiving acid reducing agents (e.g. antacids, proton pump inhibitors and H2 receptor antagonists), 200 mg once daily dose of abrocitinib should be considered (see section 4.5). Renal impairment: No dose adjustment is required in patients with mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60 to < 90 mL/min. In patients with moderate (eGFR 30 to < 60 mL/min) renal impairment, the recommended dose of Cibinqo should be reduced by half to 100 mg or 50 mg once daily. In patients with severe (eGFR < 30 mL/min) renal impairment, 50 mg once daily is the recommended starting dose. The maximum daily dose is 100 mg. Cibinqo has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy. Hepatic impairment: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Cibinqo must not be used in patients with severe (Child Pugh C) hepatic impairment. Elderly: For patients 65 years of age and older, the recommended dose is 100 mg once daily. Paediatric population: The safety and efficacy of Cibinqo in children under 12 years of age have not yet been established. No data are available. Cibinqo has been studied in adolescents 12 to < 18 years of age. However, because of bone findings in juvenile rats (comparable to a 3 month old human), additional long-term data in growing adolescents is needed to conclude that the benefits outweigh the risks. Method of administration: This medicinal product is to be taken orally once daily with or without food at approximately the same time each day.

In patients who experience nausea, taking Cibinqo with food may improve nausea. Tablets should be swallowed whole with water and should not be split, crushed, or chewed because these methods have not been studied in clinical trials. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Active serious systemic infections, including tuberculosis (TB), severe hepatic impairment, pregnancy, and breast-feeding.

Warnings and Precautions: Abrocitinib should only be used if no suitable treatment alternatives are available in patients: • 65 years of age and older; • patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers); • patients with malignancy risk factors (e.g. current malignancy or history of malignancy) Infections/serious infections: Serious infections have been reported in patients receiving Cibinqo. The most frequent serious infections in clinical studies were herpes simplex, herpes zoster and pneumonia. As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients 65 years of age and older abrocitinib should only be used if no suitable treatment alternatives are available. Treatment must not be initiated in patients with an active, serious systemic infection. Risks and benefits of treatment prior to initiating Cibinqo should be considered. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing and appropriate antimicrobial therapy should be initiated. The patient should be closely monitored, and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Tuberculosis: Tuberculosis was observed in clinical studies with abrocitinib. Patients should be screened for TB before starting treatment and yearly screening for patients in highly endemic areas for TB should be considered. Abrocitinib must not be given to patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, preventive therapy for latent TB should be started prior to initiation of treatment.

Viral reactivation: Viral reactivation, including herpes virus reactivation (e.g., herpes zoster, herpes simplex), was reported in clinical studies. The rate of herpes zoster infections was higher in patients who were treated with 200 mg, 65 years of age and older, with a medical history of herpes zoster, with a confirmed ALC < 1 × 103/mm3 prior to the event and patients with severe atopic dermatitis

at baseline. If a patient develops herpes zoster, temporary interruption of treatment should be considered until the episode resolves.

Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy and during therapy.

Patients with evidence of active hepatitis B or hepatitis C (positive hepatitis C PCR) infection were excluded from clinical studies.

Patients who were hepatitis B surface antigen negative, hepatitis B core antibody positive, and hepatitis B surface antibody positive had testing for hepatitis B virus (HBV) DNA. Patients who had HBV DNA above the lower limit of quantification (LLQ) were excluded.

Patients who had HBV DNA negative or below LLQ could initiate treatment; such patients had HBV DNA monitored. If HBV DNA is detected, a liver specialist should be consulted. Vaccination: No data are available on the response to vaccination in patients receiving Cibinqo. Use of live, attenuated vaccines should be avoided during or immediately prior to treatment. Prior to initiating treatment with this medicinal product, it is recommended that patients be brought up to date with all immunisations, including prophylactic herpes zoster vaccinations, in agreement with current immunisation guidelines. Venous thromboembolism (VTE): Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving abrocitinib. In a large randomized active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a dose dependent higher rate of VTE including deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed with tofacitinib compared to TNF inhibitors. A higher rate of VTE was observed with abrocitinib 200 mg compared to abrocitinib 100 mg. In patients with cardiovascular or malignancy risk factors abrocitinib should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than cardiovascular or malignancy risk factors, abrocitinib should be used with caution. VTE risk factors other than cardiovascular or malignancy risk factors include previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, inherited coagulation disorder. Patients should be re-evaluated periodically during abrocitinib treatment to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue abrocitinib in patients with suspected VTE, regardless of dose. Major adverse cardiovascular events (MACE): Events of MACE have been observed in patients taking abrocitinib. In a large randomized active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients 65 years of age and older, patients who are current or past long-time smokers, and patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, abrocitinib should only be used if no suitable treatment alternatives are available. Malignancy (excluding non-melanoma skin cancer [NMSC]): Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including abrocitinib. In a large randomized active controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma and non-melanoma skin cancer (NMSC) was observed with tofacitinib compared to TNF inhibitors. A higher rate of malignancies (excluding non-melanoma skin cancer, NMSC) was observed with abrocitinib 200 mg compared to abrocitinib 100 mg. In patients 65 years of age and older, patients who are current or past long-time smokers, or with other malignancy risk factors (e.g. current malignancy or history of malignancy), abrocitinib should only be used if no suitable treatment alternatives are available. Non-melanoma skin cancer: NMSCs have been reported in patients receiving abrocitinib. Periodic skin examination is recommended for all patients, particularly those who are at increased risk for skin cancer. Haematologic abnormalities: Confirmed ALC < 0.5 × 103/mm3 and platelet count < 50 × 103/mm3 were observed in less than 0.5% of patients in clinical studies. Treatment with abrocitinib should not be initiated in patients with a platelet count < 150 × 103/mm3, an ALC < 0.5 × 103/mm3, an ANC < 1.2 × 103/mm3 or who have a haemoglobin value < 10 g/dL. Complete blood count should be monitored 4 weeks after initiation of therapy and thereafter according to routine patient management. Lipids: Dose dependent increases in blood lipid parameters were reported in patients treated with abrocitinib compared to placebo. Lipid parameters should be assessed approximately 4 weeks following initiation of therapy and thereafter according to the patient’s risk for cardiovascular disease. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Patients with abnormal lipid parameters should be further monitored and managed according to clinical guidelines, due to the known cardiovascular risks associated with hyperlipidaemia. Elderly: The safety profile observed in elderly patients was similar to that of the adult population with the following exceptions: a higher proportion of patients 65 years of age and older discontinued from clinical studies and were more likely to have serious adverse reactions compared to younger patients; patients 65 years and older were more likely to develop low platelet and ALC values; the incidence rate of herpes zoster in patients 65 years of age and older was higher than that of younger patients. There are limited data in patients above 75 years of age. Use in patients 65 years of age and older: Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients 65 years of age and older, as observed in a large randomised study of tofacitinib (another JAK inhibitor), abrocitinib should only be used in these patients if no suitable treatment alternatives are available. Immunosuppressive conditions or medicinal products: Patients with immunodeficiency disorders or a first-degree relative with a hereditary immunodeficiency were excluded from clinical studies and no information on these patients is available. Combination with biologic immunomodulators, potent immunosuppressants such as ciclosporin or other Janus kinase (JAK) inhibitors has not been studied. Their concomitant use with abrocitinib is not recommended as a risk of additive immunosuppression cannot be excluded. Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Drug Interactions: Potential for other medicines to affect pharmacokinetics of abrocitinib: Abrocitinib is metabolised predominantly by CYP2C19 and CYP2C9 enzymes, and to a lesser extent by CYP3A4 and CYP2B6 enzymes, and its active metabolites are renally excreted and are substrates of the organic anion transporter 3 (OAT3). Therefore, exposures of abrocitinib and/or its active metabolites may be affected by medicinal products that strongly inhibit or induce theses enzymes and transporter. Dose adjustments, as appropriate, may be required. Co-administration with products which increase gastric pH: When abrocitinib 200 mg was administered concomitantly with famotidine 40 mg, an H2-receptor antagonist, abrocitinib active moiety exposures decreased by approximately 35%. The effect of elevating gastric pH with antacids, or proton pump inhibitors (omeprazole) on the pharmacokinetics of abrocitinib

CIBINQO 200 mg offers

RAPID and SUPERIOR

RELIEF

vs dupilumab1

Results through week 2 in a head-to-head study of CIBINQO 200 mg vs dupilumab with background TCS.

Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy2 RAPID

H R E LI E

F

I

TC

With week 2 PP-NRS4 data: 48% of adults

taking CIBINQO 200 mg achieved PP-NRS4 at week 2 compared to

26% of adults

taking dupilumab (P<0.0001)

Additional information: PP-NRS4 response for CIBINQO vs dupilumab at week 2 was a primary endpoint controlled for multiplicity. The onset of pruritus relief was assessed through a step-down approach, day by day, from week 2 to earlier time points once statistical significance was demonstrated at week 2, at the 5% level of significance. P value at day 2 is controlled for multiplicity for the family of PP-NRS4 comparisons.

TCS includes low- to medium-potency topical corticosteroids and other medicated topicals.

PP-NRS4 is a 4 point or more improvement in Peak Pruritus Numerical Rating Scale.

has not been studied and may be similar to that seen with famotidine. The higher 200 mg daily dose should be considered for patients treated concomitantly with products which increase gastric pH, as they may reduce the efficacy of abrocitinib. Potential for Cibinqo to affect pharmacokinetics of other medicinal products: No clinically significant effects of Cibinqo were observed in drug interaction studies with oral contraceptives. Caution should be exercised for concomitant use of abrocitinib with dabigatran. Caution should be exercised as the levels of P-gp substrates with a narrow therapeutic index, such as digoxin, may increase. Caution should be exercised when using abrocitinib concomitantly with narrow therapeutic index medicines that are primarily metabolised by CYP2C19 enzyme (e.g. S mephenytoin and clopidogrel). Dose adjustment may be required for other medicines primarily metabolised

by CYP2C19 enzyme in accordance with their product information (e.g. citalopram, clobazam, escitalopram and selumetinib).

Fertility, pregnancy, and lactation: Women of childbearing potential: Women of reproductive potential should be advised to use effective contraception during treatment and for 1 month following the final dose of Cibinqo. Pregnancy planning and prevention for females of reproductive potential should be encouraged. Pregnancy: There are no or limited amount of data on the use of abrocitinib in pregnant women. Studies in animals have shown reproductive toxicity. Abrocitinib has been shown to cause embryo-foetal lethality in pregnant rats and rabbits, skeletal variations in the foetuses of pregnant rats and rabbits and to affect parturition and peri/ postnatal development in rats. Cibinqo is contraindicated during pregnancy. Breast-feeding: There are no data on the presence of abrocitinib in human milk, the effects on the breast fed infant, or the effects on milk production. Abrocitinib was secreted in milk of lactating rats. A risk to newborns/infants cannot be excluded and Cibinqo is contraindicated during breast feeding. Fertility: Based on the findings in rats, oral administration of Cibinqo may result in temporary reduced fertility in females of reproductive potential. The effects on female rat fertility were reversible 1 month after cessation of abrocitinib oral administration. Driving and operating machinery: Cibinqo has no effect on the ability to drive or use machines. Side Effects: The most commonly reported adverse reactions are nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), vomiting (3.5%), dizziness (3.4%) and abdominal pain upper (2.2%). The most frequent serious adverse reactions are infections (0.3%) including herpes simplex, herpes zoster, and pneumonia. Refer to SmPC for further information on side effects. Legal Category: S1A. Marketing Authorisation Numbers: EU/1/21/1593/002 - Cibinqo 50 mg (28 film-coated tablets), EU/1/21/1593/007 - Cibinqo 100 mg (28 film-coated tablets); EU/1/21/1593/012 - Cibinqo 200 mg (28 film-coated tablets). Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact Pfizer Medical Information on 1800 633 363 or at medical.information@ pfizer.com. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 467 6500. ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Last revised: 03/2023.

Ref: CQ 5_0 IE. References: 1. Reich K, Thyssen JP, Blauvelt A, et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, doubleblind, multicentre phase 3 trial. Lancet. 2022;400(10348):273-282.

2. Cibinqo Summary of Product Characteristics.

© 2023 Pfizer Inc. All rights reserved. PP-CIB-IRL-0125 | August 2023.

NOW AVAILABLE

Stelara One-Press ®

• 97% of patients say it is easy to use1 • 4-6 maintenance doses a year*2 • Significant long-term remission for your Crohn’s patients (5 years)3

Same Stelara … now even simpler1 ®

STELARA® 45 mg and 90 mg solution for injection in pre-filled syringe. STELARA® 45 mg and 90 mg solution for injection in pre-filled pen. STELARA® 45 mg solution for injection. STELARA® 130 mg concentrate for solution for infusion. PRESCRIBING INFORMATION. ACTIVE INGREDIENT(S): Ustekinumab. Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATION(S): Plaque psoriasis adults: Treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate or PUVA. Plaque psoriasis paediatrics: Moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis: Alone or in combination with methotrexate for treatment of active psoriatic arthritis in adult patients when response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Crohn’s disease: Treatment of adult patients with moderately to severely active Crohn’s disease who had inadequate response with/lost response to/were intolerant to either conventional therapy or TNFα antagonist or have contraindications to such therapies. Ulcerative colitis: Treatment of adult patients with moderately to severely active ulcerative colitis who had an inadequate response with/lost response to/were intolerant to either conventional therapy or a biologic or have contraindications to such therapies. DOSAGE & ADMINISTRATION: Adults: Under guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis/ psoriatic arthritis/Crohn’s disease/ulcerative colitis. Psoriasis or psoriatic arthritis. Subcutaneous (s.c.) injection. Avoid areas with psoriasis. Self-injecting patients or caregivers ensure appropriate training. Physicians are required to follow-up and monitor patients. Plaque psoriasis, adults & elderly: Patients up to and including 100kg, 45 mg at week 0 followed by a 45 mg dose at week 4, then every 12 weeks. Patients greater than 100 kg, 90 mg at week 0 followed by a 90 mg dose at week 4, then every 12 weeks (45 mg was less effective in these patients).

Plaque psoriasis paediatrics (6 years and older): Patients under 60 kg, 0.75 mg/kg at week 0, followed by 0.75 mg/kg at week 4 then every 12 weeks thereafter. Patients 60 - 100kg, 45 mg at week 0 followed by 45 mg at week 4, then every 12 weeks. Patients greater than 100 kg, 90mg at week 0, followed by 90mg at week 4, then every 12 weeks. The pre-filled pen has not been studied in the paediatric population and is not recommended for use in paediatric patients. Psoriatic arthritis, adults & elderly: 45 mg at week 0 followed by a 45 mg dose at week 4, then every 12 weeks. Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg. Consider discontinuation if no response after 28 weeks. Crohn’s disease and ulcerative colitis: Initial single intravenous infusion dose based on body weight (260 mg or 390 mg or 520 mg) diluted in sodium chloride solution and given over at least one hour. At week 8 after intravenous dose, 90 mg s.c. dose is given; followed by every 12 weeks (or 8 weeks based on clinical judgement). Consider discontinuation if no response 16 weeks after the IV induction dose or 16 weeks after switching to the 8-weekly maintenance dose. Immunomodulators and/or corticosteroids may be continued but consider reducing/discontinuing corticosteroids if responding to Stelara.

In Crohn’s disease, if therapy interrupted, resume s.c. every 8 weeks if safe/effective. Children: under 6 years - Not recommended for psoriasis. under 18 years - Not recommended for psoriatic arthritis, Crohn’s disease and ulcerative colitis. Renal & Hepatic impairment: Not studied. CONTRAINDICATIONS: Hypersensitivity to product; clinically important, active infection. SPECIAL WARNINGS & PRECAUTIONS: Infections: Potential to increase risk of infections and reactivate latent infections. Opportunistic infections have been reported in patients treated with ustekinumab. Caution in patients with a chronic infection or history of recurrent infection, particularly TB. Patients should be evaluated for tuberculosis prior to initiation of STELARA. Consider anti-tuberculosis therapy prior to initiation of STELARA in patients with history of latent or active tuberculosis. Patients should seek medical advice if signs or symptoms suggestive of an infection occur. If a serious infection develops, closely monitor and STELARA should not be administered until infection resolves. Malignancies: Potential to increase risk of malignancy. Risk of malignancy may be higher in psoriasis patients treated with other biologics. No studies in patients with history of malignancy or in patients who develop malignancy while receiving STELARA. Monitor all patients, in particular those older than 60, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment for non-melanoma skin cancer. Cardiovascular events:

Cardiovascular events have been observed in patients with psoriasis in a post marketing observational study; cardiovascular risk factors should be regularly assessed during treatment. Concomitant immunosuppressive therapy: Caution, including when changing immunosuppressive biologic agents. Hypersensitivity reactions: Serious hypersensitivity reactions (anaphylaxis and angioedema) reported, in some cases several days after treatment. If these occur appropriate therapy should be instituted and STELARA discontinued. Latex sensitivity: Needle cover contains natural rubber (latex), may cause allergic reactions. Immunotherapy: Not known whether STELARA affects allergy immunotherapy. Serious skin conditions: Exfoliative dermatitis reported following treatment. Discontinue STELARA if drug reaction is suspected. Infusion-related anaphylactic reactions to the infusion have been reported. If a serious or life-threatening reaction is observed, appropriate therapy should be instituted and ustekinumab should be discontinued. Vaccines: Administration of live vaccines to infants is not recommended for six months following birth. Lupus-related conditions: Cases of lupus-related conditions have been reported in patients treated with ustekinumab. SIDE EFFECTS: Common: upper respiratory tract infection, nasopharyngitis, sinusitis, dizziness, headache, oropharyngeal pain, diarrhoea, nausea, vomiting, pruritus, back pain, myalgia, arthralgia, fatigue, injection site erythema, injection site pain. Other side effects: cellulitis, serious hypersensitivity reactions (including anaphylaxis, angioedema), skin exfoliation, exfoliative dermatitis, lower respiratory tract infection. Very rare: bullous pemphigoid, cutaneous lupus erythematosus, lupus-like syndrome. Studies show adverse events reported in children 12 years and over with plaque psoriasis were similar to those seen in previous studies in adults with plaque psoriasis. Refer to SmPC for other side effects. LEGAL CATEGORY: Prescription Only Medicine (POM). PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S): 45 mg, 1 x vial, EU/1/08/494/001; 45 mg, 1 x 0.5 ml pre-filled syringe, EU/1/08/494/003; 90 mg, 1 x 1.0 ml pre-filled syringe, EU/1/08/494/004; 130 mg,1 x vial, EU/1/08/494/005; 45mg, 1 x 0.5ml pre-filled pen, EU/1/08/494/006; 90mg, 1 x 1ml pre-filled pen, EU/1/08/494/007. MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

FURTHER INFORMATION IS AVAILABLE FROM: Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, IRL - Co. Cork, P43 FA46. Prescribing information last revised: June 2023.

Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse events via: HPRA Pharmacovigilance Website: www.hpra.ie. Adverse events should also be reported to Janssen Sciences Ireland UC on 1800 709 122 or at dsafety@its.jnj.com. © Janssen-Cilag International NV 2023 * Following an initial IV dose at week 0 and 90mg SC injection at week 8. Doses of STELARA® SC will be given 12 weekly (or 8 weekly based on clinical judgement) thereafter.

References: 1. Ferris L, et al. J Dermatolog Treat. 2016; 31(2): 152-159. 2. Stelara, Summary of Product Characteristics. Available at medicines.ie. 3. Sandborn, W. et al. Clin Gastroenterol Hepatol. 2022;20(3):578-590.

CP-416115 | Date of Preparation: October 2023

December Issue Professional 100 Issue

5

Contents

Foreword

Professor Deborah McNamara received prestigious Fellowship P6

Editor One of our lead news stories this month details the ‘shock’ of the Irish Medical Organisation (IMO) at HSE plans to implement a recruitment freeze among a wide range of healthcare staff including non-consultant hospital doctors (NCHDs); a decision which will inevitably impact negatively on patient care, they say.

Hospital pharmacy survey on medicine shortages P10 6

Asthma Society of Ireland look back on 2023 P17

Dr Rachel McNamara, Chair of the IMO NCHD Committee, said, “This recruitment freeze flies in the face of safe staffing levels. It will add to the chaos in a system which already does not have enough doctors to deliver safe patient care, where many teams across the country are not fully staffed and where NCHDs are still working illegal and unsafe hours.

Achievements and Challenges for Thrombosis Ireland P26

“It is astounding that this decision could be made at this point in time.” Turn to page 8 for the full story.

Prostate Cancer trials presented at ESMO 2023 P38

38

Pfizer publishes the Health and Science Index P48 Calls for a National Osteoporosis Society P51 Professional 100 2023 P56 48

REGULARS

CPD: Atrial Fibrillation P43 Feature: Glaucoma P50 Review: HPN 2023 Review P52 Clinical R&D: P96 Hospital Professional News is a publication for Hospital Professionals and Professional educational bodies only.

All rights reserved by Hospital Professional News. All material published in Hospital Professional News is copyright and no part of this magazine may be reproduced, stored in a retrieval system or transmitted in any form without written permission. IPN Communications Ltd have taken every care in compiling the magazine to ensure that it is correct at the time of going to press, however the publishers assume no responsibility for any effects from omissions or errors.

PUBLISHER IPN Communications Ireland Ltd Clifton House, Lower Fitzwilliam Street, Dublin 2 (01) 669 0562 GROUP DIRECTOR Natalie Maginnis n-maginnis@btconnect.com EDITOR Kelly Jo Eastwood EDITORIAL danielle@hospitalprofessionalnews.ie ACCOUNTS Fiona Bothwell cs.ipn@btconnect.com

Professional Top 100 2016, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News,

56

SALES EXECUTIVE Avril Boyd avril@hospitalprofessionalnews.ie SALES & TRAINING MANAGER Sibongile Mude s.mude@hospitalprofessionalnews.ie CONTRIBUTORS Lorraine Nolan Angela Fitzgerald Ruth Morrow Amy Kelly Ann Marie O’Neill Theresa Lowry-Lehnen Aoife McNamara Chris Macey Dr Dara Chesser Dr Rayka Modabberi Dr Usama Boles Daniel Waring Mr Pavi Agrawal DESIGN DIRECTOR Ian Stoddart Design HOSPITALPROFESSIONALNEWS.IE

@HospitalProNews HospitalProfessionalNews

In other news, the European Association of Hospital Pharmacists has released the most recent results of its shortages investigation, which for the first time covers medical devices in addition to medicine shortages. In particular, the percentage of hospital pharmacists reporting shortages to be an issue in terms of delivering the best care to patients has seen a significant increase in the past 5 years along with 95% of hospital pharmacists stressing that medicines shortages are a problem faced regularly in their daily work. You can read more about this on page 10.

The December issue of HPN carries a series of contributed articles from some of Ireland’s leading Associations and Regulatory Bodies, all of whom look back at the challenges and achievements of 2023 with a nod to the opportunities for 2024.

These include the HPRA on page 14 as Dr Lorraine Nolan identifies what has been a busy year for the Association. “While we can be certain that many of the developments that emerged in 2023 will continue into the new year and beyond, I look forward to seeing how the HPRA will continue to rise to these challenges and meet them head on,” she says.

Angela Fitzgerald, CEO of HIQA notes on page 20 the extraordinary efforts by staff in health and social care settings during the pandemic and beyond to meet the needs of people using services.

But she adds, “There is no doubt that there has also been a significant impact on staff arising from these sustained efforts in terms of fatigue and overall resilience. In terms of patient and service user experience, it is also important to acknowledge that these combined challenges have also had an impact on those using health and social services in terms of timely access and safe effective care.”

We also feature our annual Professional 100 in this issue. It is fair to say the dedication, passion and innovation behind the profession is never lacking.

May I take this opportunity to wish all of our readers and clients a very Merry Christmas and a prosperous New Year.

HOSPITAL PROFESSIONAL NEWS IRELAND Ireland’s Dedicated Hospital Professional Publication

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

6

News

Professional Conduct & Ethics Guide The Medical Council has launched the 9th edition of its Guide to Professional Conduct & Ethics for Registered Medical Practitioners.

The Guide seeks to support doctors by providing principles– based guidance on how to best work in partnership with patients.

It covers a wide range of topics and scenarios likely to arise over the course of their professional careers. The Guide is also useful for patients as it clarifies the standards of care they should expect from their doctor.

Following a consultation process with members of the public, doctors, and a range of partner organisations on issues relating to doctors’ professional conduct and ethics, this version amends the 8th edition of the Guide, which was released in 2019. The Guide reflects international guidance and will be supported by position statements in certain specialty areas, for example, telehealth and prescribing.

It contains new and revised guidance for doctors on areas including:

• Broadening of guidance on communicating with the public, including social media • Guidance for doctors acting as expert witnesses • Guiding Values and Principles in managing situations with patients, covering honesty, integrity, putting patients first, treating patients with dignity and respect • Updated section on responsible use of health resources, and advocating for patients and services • Use of the terms ‘must’ and ‘should’ and ‘judgement’ • Guidance for doctors on professional conduct and professional ethics, with doctors encouraged to seek other sources of guidance to inform their practice, including national, international, and organisational standards and policies, clinical and specialty specific standards and guidelines

To coincide with the launch of the Guide, the Medical Council is also publishing public opinion research, which seeks to understand public attitudes towards and experience of doctors, and the extent to which the public is taking an active role in their healthcare. It reveals insights on trust in the medical profession, personal health, and public opinion about what doctors should and should not do: • Doctors ranked second highest (after Teachers) as the most trusted profession in Irish society, with 9 in 10 people (89%) trusting their doctor to tell the truth • While 94% of adults are registered with a GP or GP practice, one in four individuals (25%) report not having visited their GP in the past year, a notable increase compared to 15% in 2020. Additionally, there has been a substantial decrease in the number of individuals visiting their GP as frequently • However, the use of telemedicine services has

significantly increased, with around one in four (24%) of adults accessing these services, including 21% who have used GP services through telemedicine, a marked increase from 2% in 2020.

Telemedicine usage is highest among 35–49 year-olds, and those residing in Dublin • 9% have used social media to seek guidance from a doctor who uses their social media platform to provide medical advice 1. Of those who have used social media in this way, 11% say that they checked if the doctors were registered The Medical Council appointed an Ethics Committee to specifically review and advise on any required edits to the Guide to Professional Conduct & Ethics for Registered Medical Practitioners. The Group, chaired by Medical Council President Dr Suzanne Crowe, presented its recommendations to the full Medical Council which has now updated the Guide.

Galway Unveils Radiation Oncology Centre Tony Canavan, CEO, Saolta University Health Care Group; Marie Burns, Director of Nursing, GUH; Dr Cormac Small, Consultant Radiation Oncologist, UHG; Chris Kane, General Manager, GUH; Stephen Donnelly, Minister for Health TD; Ann Cosgrove, Chief Operating Officer, Saolta University Health Care Group; Dr Joe Martin, Consultant Radiation Oncologist, UHG; and Dr Pat Nash, Chief Clinical Director, Saolta University Health Care Group

University Hospital Galway and the Saolta Group has announced the official opening of the state-ofthe-art Saolta Radiation Oncology Centre. The newly built Radiology Oncology Centre which opened in UHG on a phased basis equipped to the highest specification, providing advanced radiotherapy treatment for cancer patients all across the West and North West.

The centre was officially opened by Minister for Health Stephen Donnelly TD on Friday, October 20th.

Building of the 8,000sqm facility commenced in 2020 on the site of the former acute mental health unit at the hospital with an overall project budget of ¤70.7m. The new three-storey building includes six radiotherapy treatment vaults using the most advanced linear accelerator technology. These provide improved imaging and allowing greater precision and accuracy in targeting disease.

These machines can deliver stereotactic radiotherapy treatment which is a highly focused

technique delivering ultra-precise treatment to tumours. This advancement will ensure that patients will no longer have to travel to Dublin for this treatment.

Three of the linear accelerators are currently operational with one more coming on stream on a phased basis. The remaining two vaults will allow for future expansion.

A new brachytherapy suite has been built containing a state of the art surgical theatre and treatment rooms, along with a new superficial

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

suite for skin treatments. The centre also includes a new radiation oncology outpatient suite with 12 clinic rooms and facilities for patient review and support.

The new centre will welcome the installation of the country’s first MRI-RT simulator next year. This is a MRI scanner specifically for the needs of Radiation Oncology patients, it allows better soft tissue definition and again improves the precision in targeting the disease.

Welcoming the new centre, Prof Michael Kerin, Director of the Cancer Managed Clinical Academic Network (MCAN) for Saolta added: “This represents a step change in our ability to deliver fit for purpose cancer care in a modern environment. The radiotherapy programme is a key component of cancer therapy and this facility will ensure that the patients from the west of Ireland can receive international class outcomes from this part of their cancer journey- we are very grateful for this important investment in the regional cancer programme.”

News

7

Irish Doctor Mental Health Concerns Two in five doctors in Ireland (40%) say their mental health is worse now than it was during the pandemic, and a similar amount (38%) are considering their future in healthcare due to mental health concerns, according to the Medical Protection Society (MPS).

The MPS survey findings, published at MPS’s annual medical conference in Dublin, show that a third of the 900 doctors surveyed (33%) say not being able to do the right thing for patients, or ‘moral injury’, is affecting their current mental health. Others point to the impact of exhaustion on patient safety (43%) and the inability to take breaks to eat and drink (36%).

More than four in five doctors (82%) go on to say that staff shortages make it difficult for them to take time off to deal with mental health issues, and nearly three quarters (74%) feel the Government could do more to help doctors with mental health issues.

the profession with mental wellbeing issues, and indeed the Government must play its part by ensuring mental health services for doctors are funded and effective, however we recognise this is not just a challenge to be met by the Government.

Dr Rachel Birch, Medicolegal Consultant at MPS, said, “Clearly many healthcare professionals in Ireland are becoming increasingly exhausted and disillusioned due to the variety of challenges and pressures they face daily – pressures which unfortunately will take some time to resolve.

“We as doctors have a responsibility to attend to our own mental health and ultimately ensure we continue to perform at our best for patients. Doctors should avoid self-assessing their mental health and should have their own GP to ensure they are properly cared for.

“Three quarters of the doctors we surveyed feel the Government should do more to support

“The reality is that swathes of passionate, committed doctors,

who we must retain in the workforce, are on the verge of quitting due to mental health concerns. Doing nothing is simply not an option.

“We urge healthcare professionals who are struggling, to make use of the mental wellbeing resources available – for example, MPS provides an independent, 24/7 counselling service for those experiencing stress that they feel could impact their practice, as a benefit of membership. There is also the Practitioner Health Matters Programme, and the Health in Practice Programme which is run by the Irish College General Practitioners.”

Honorary Fellowship for Prof McNamara Professor Deborah McNamara, Vice-President RCSI, consultant general and colorectal surgeon at Beaumont Hospital and co-lead of the National Clinical Programme for Surgery, has been made an Honorary Fellow of the American College of Surgeons.

A graduate of Trinity College Dublin, Professor McNamara completed her basic and higher surgical training in general surgery in Ireland and published her MD thesis on the subject of angiogenesis under the supervision of Professor David Bouchier-Hayes. She then completed fellowship training in coloproctology at Hôpital Saint Antoine, Paris, where she specialised in the operative management of rectal cancer.

Professor McNamara also holds qualifications in quality improvement, leadership and implementation science.

During her training, Professor McNamara received the Patey Prize of the Surgical Research Society, the Meath Hospital Senior Clinical Medal in Medicine and Surgery, the Arthur Ball Prize in Surgery, and the De Renzy Centenary Prize. In addition, she delivered the 2005 Millin Lecture, a prestigious award recognising excellence in original surgical research.

Following her appointment as a consultant general and colorectal surgeon at Beaumont Hospital in 2003, she was appointed clinical director for surgery at Beaumont Hospital, where she has led the development of the hospital’s colorectal cancer biobank and contributed to research collaborations between Beaumont clinicians and RCSIaffiliated scientists.

She founded the betterbeaumont quality improvement learning collaborative in 2014 to support a range of hospital-based improvement activities.

RCSI Vice-President Professor Deborah McNamara at the conferring of her honorary fellowship of the American College of Surgeons

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

8

News

Shock at HSE Recruitment Freeze Plans The Irish Medical Organisation (IMO) has said it is shocked and appalled at HSE plans to implement a recruitment freeze among a wide range of healthcare staff including non-consultant hospital doctors (NCHDs), a decision which will inevitably impact negatively on patient care.

Dr Rachel McNamara, Chair of the IMO NCHD Committee, said, “This recruitment freeze flies in the face of safe staffing levels. It will add to the chaos in a system which already does not have enough

doctors to deliver safe patient care, where many teams across the country are not fully staffed and where NCHDs are still working illegal and unsafe hours.

“It is astounding that this decision could be made at this point in time. Even in the depths of austerity there was no recruitment freeze on medical professionals as it was recognised that delivery of services had to be prioritised. It is all the more ironic that swingeing cuts to staff and budgets, imposed during austerity, is what damaged

the health service for over a decade and we are now repeating the same mistakes.”

Dr John Cannon, President of the IMO, said: “NCHDs across all specialties are already working hours that are in excess of legal working hour legislation, and are burnt out working in a system that is completely unfit for purpose.

It is little wonder that so many of our doctors simply choose to emigrate to systems that recognise their worth.

“The system requires more, not fewer doctors, just to meet service demand. The additional NCHDs that were recruited this year were the minimum required to deliver those services and the HSE acknowledged to the IMO that a further 800 posts were required so that working hours could be reduced in line with the NCHD Agreement reached between the HSE and the IMO in December 2022. They are now quite simply abandoning their own legal obligations as an employer.”

HPV Vaccination Updates Evening-time clinics have been announced for Sligo as part of The Laura Brennan HPV Catch-up Vaccination Programme.

The programme has now been expanded to include: • All unvaccinated students in 2nd to 6th year of secondary school homeschool or a special school - both boys and girls.

• All unvaccinated females who have left second level education and are 24 years or younger on the date of offer of vaccination • All unvaccinated males who have left second level education and are 21 years old or younger on the date of offer of vaccination.

• Refugees and Applicants Seeking Protection in Ireland who are unvaccinated and gender and age equivalent to the above listed groups are also eligible for catch-up HPV vaccination under the Laura Brennan HPV Catch-up Vaccination Programme.

The most common cancer caused by the HPV virus is cervical cancer - cancer of the neck of the womb. However, the HPV virus can cause other cancers and conditions that can affect boys, and since September 2019, boys have also been offered the HPV vaccine. The more young people vaccinated - both boys and girls - the better the spread of the infection can be controlled.

Over 500,000 people have already received the HPV vaccine through the HSE school vaccination programme.

Irish Thank You to Life Saving Consultant Heart attack survivor Mark Lang, right, with his wife Julie and Professor Noel Caplice of Cork University Hospital. Pic: Brian Lougheed

“I woke up at 3am and thought I had indigestion, I started to be sick and after an hour, I had a shower; I thought that might help me feel a bit better,” recalled Mark. “I lay down for about 20 minutes, woke up again and the pain was so intense in my hands and jaw, I told Julie I needed to get to hospital.”

A tourist has returned to an Irish hospital to thank the Consultant Cardiologist who saved his life during a severe heart attack. Mark Lang’s wife Julie, 51, believes her husband would not have survived had the holidaying English couple not been staying within minutes of Cork University Hospital.

The former amateur rugby league player suffered three cardiac arrests and was revived each time.

After returning recently to thank the team which brought him back from the brink, Mark, 56, said: “Professor Noel Caplice told me, “You were knocking at those gates (of heaven) a few times and we weren’t letting you go in’.”

The dad-of-two’s health nightmare began on February 26 last, just hours after the couple, from Ormskirk, 20km north of Liverpool, enjoyed a night out in Cork.

The A&E department at CUH’s Wilton campus is just seven minutes’ drive from the Kingsley Hotel, where the Langs were staying. In the time it took Julie to park their car, Mark was whisked to the hospital’s resus area as an emergency team prepared him for the cath lab and stent insertion.

She believes fate stepped in to save her husband - a planned holiday in Kraków with friends had been postponed days earlier,

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

so they booked a short break in Ireland instead.

“At home, our local hospital is 20 minutes away. If we were here, Mark could have arrested in the car and might not have survived.

It obviously wasn’t his time to go,” she said.

Weighbridge operator Mark is now on the road to recovery, but living with a heart function rate of just 27%.

A three-week stint in CUH’s coronary care unit was followed by the fitting of an ICD (defibrillator) and pacemaker at Spire Hospital in Manchester and further care at Liverpool Heart and Chest Hospital.

Last month, Mark and Julie returned to Cork to present CUH Charity (the hospital’s fundraising arm) with a donation from players at Ormskirk Rugby Club, where he coached for 15 years and Julie was a club steward.

“I only realised when I was talking to Prof Caplice afterwards, how close I was to not being here at all,” said Mark. “It gives you a true appreciation of what they do.”

APEXXNAR® is indicated for active immunisation for the prevention of invasive disease and pneumonia caused

by Streptococcus pneumoniae in individuals 18 years of age and older.1

Designed to deliver long-lasting immunity.1,2

Helps protect against the 20 Streptococcus pneumoniae serotypes included in the vaccine.1

ABBREVIATED PRESCRIBING INFORMATION – IRELAND

▼

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Apexxnar®▼ suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) Presentation: Each 0.5 mL dose of Apexxnar contains 2.2 micrograms of each of the following polysaccharide serotypes: 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F and 4.4 micrograms of polysaccharide serotype 6B. Each polysaccharide is conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate. 1 dose (0.5 mL) contains approximately 51 µg CRM197 carrier protein and 0.125 mg aluminium.

Indications: Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. Apexxnar should be used in accordance with official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

Dosage and Administration: For intramuscular injection. Individuals ≥ 18 years of age and older: One single dose. The need for revaccination with a subsequent dose of Apexxnar has not been established. Based on the clinical experience with Prevenar 13, if the use of 23-valent pneumococcal polysaccharide vaccine is considered appropriate, Apexxnar should be given first. Special populations: There are no data with Apexxnar in special populations. Limited experience from clinical studies with Prevenar 13 are available in adults at higher risk of pneumococcal infection either immunocompromised individuals or following bone marrow transplantation.

Based on these data the following posology was recommended for Prevenar 13: Individuals at higher risk of pneumococcal infection (e.g., individuals with sickle cell disease or HIV infection), including those previously vaccinated with 1 or more doses of PPSV23, were recommended to receive at least 1 dose of Prevenar 13. In individuals with a hematopoietic stem cell transplant (HSCT), the recommended immunisation series with Prevenar 13 consisted of 4 doses of 0.5 mL each. The primary series consisted of 3 doses, with the first dose given 3 to 6 months after HSCT and with an interval of at least 1 month between doses. A booster dose was recommended 6 months after the third dose.

Contra-indications: Hypersensitivity to the active substances, to any of the excipients, or to diphtheria toxoid.

Warnings and Precautions: Do not administer intravascularly. Appropriate medical treatment and supervision must be available in case of anaphylaxis. Vaccination should be postponed in individuals suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. It should not be given to individuals with thrombocytopenia or a bleeding disorder that would contraindicate intramuscular injection. The risk of bleeding in patients with coagulation disorders needs to be carefully evaluated before intramuscular administration of any vaccine, and subcutaneous administration should be considered if the potential benefit clearly outweighs the risks. Apexxnar will only protect against Streptococcus pneumoniae serotypes included in the vaccine and will not protect against other microorganisms that cause invasive disease and pneumonia. As with any vaccine, Apexxnar may not protect all individuals receiving the vaccine from pneumococcal disease. Safety and immunogenicity data on Apexxnar are not available for individuals in immunocompromised groups. Vaccination should be considered on an individual basis. Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic

defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunisation. The clinical relevance of this is unknown. In adults across all studied age groups, formal non-inferiority criteria were met although numerically lower geometric mean titres were observed with Apexxnar for most of the serotypes compared to Prevenar 13, however the clinical relevance of this observation for immunocompromised individuals is unknown.

Drug Interactions: Apexxnar may be administered concomitantly with seasonal influenza vaccine (QIV; surface antigen, inactivated, adjuvanted). In subjects with underlying conditions associated with a high risk of developing life-threatening pneumococcal disease, consideration may be given to separating administrations of QIV and Apexxnar (e.g., by approximately 4 weeks). Apexxnar can be administered concomitantly with COVID-19 mRNA vaccine (nucleoside modified).

Fertility, Pregnancy & Lactation: There are no data from the use of Apexxnar in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Administration of Apexxnar in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. It is unknown whether Apexxnar is excreted in human milk. Side Effects: As Apexxnar contains the same 13 serotype-specific capsular polysaccharide conjugates and the same vaccine excipients as Prevenar 13, the adverse reactions already identified for Prevenar 13 have been adopted for Apexxnar. In clinical trials, the safety profile of Apexxnar was similar to that of Prevenar 13. No new adverse reactions were identified as compared to Prevenar 13. When Apexxnar was administered to adults aged ≥ 65 years together with the third (booster) dose of a COVID-19 mRNA vaccine (nucleoside modified), the tolerability profile generally resembled that of the COVID-19 mRNA vaccine (nucleoside modified) administered alone. Very common (≥ 1/10): Headache, joint pain, muscle pain, vaccination-site pain/tenderness, fatigue. Common (≥ 1/100 to < 1/10): Vaccination-site induration/ swelling, vaccination-site erythema, pyrexia. Uncommon (≥ 1/1,000 to < 1/100): Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm, diarrhoea, nausea, vomiting, rash, angioedema, vaccination-site pruritus, lymphadenopathy, vaccination-site urticaria, chills. The following adverse reactions have been spontaneously reported during the postmarketing use of Prevenar 13, which may also occur with Apexxnar. These events were reported voluntarily from a population of uncertain size, so it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure: Anaphylactic/anaphylactoid reaction, including shock, erythema multiforme, vaccination-site dermatitis. Additional information in special populations in studies with Prevenar 13: Adults with HIV infection have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common and nausea common. Adults with an HSCT have similar frequencies of adverse reactions, except that pyrexia, vomiting, and diarrhoea were very common.

For full prescribing information see the Summary of Product Characteristics.

Legal Category: S1A. Package Quantities: Pack of 1 single-dose pre-filled syringe (with separate needle).

Marketing Authorisation Numbers: EU/1/21/1612/002. Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500.

Last revised: 12/2022.

Ref: PE 3_0.

References 1. APEXXNAR. Summary of Product Characteristics.

2. Froes F, Roche N, Blasi F. Pneumococcal vaccination and chronic respiratory diseases. Int J Chron Obstruct Pulmon Dis. 2017;12:3457-3468.

PP-PNR-IRL-0027 | Date of Preparation: May 2023

For more information about APEXXNAR® scan the QR code

10 News

Hospital Pharmacy Survey on Medicine Shortages For over a decade, members of the European Association of Hospital Pharmacists (EAHP) have increasingly reported difficulties in sourcing medicines required in their hospitals. However, despite the early advocacy efforts by EAHP and the ongoing interventions of its members, reports on medicines shortages continued to materialise at an accelerating speed throughout Europe. To establish a better understanding of the problem in European hospitals, EAHP conducted different surveys in 2013, 2014, 2018, 2019 and 2023, which illustrated the far-reaching consequences that medicines shortages pose.

Last month, EAHP released the most recent results of its shortages investigation, which for the first time covers medical devices in addition to medicine shortages.

In particular, the percentage of hospital pharmacists reporting shortages to be an issue in terms of delivering the best care to patients has seen a significant increase in the past 5 years along with 95% of hospital pharmacists stressing that medicines shortages are a problem faced regularly in their daily work.

For medical devices, all four professional groups that replied to the survey had very similar views with 61% of hospital pharmacists, 57% of physicians, 55% of other healthcare professionals and 46%

of nurses indicating that these have caused problems for their patients.

The causes of medicine shortages that were mentioned by survey respondents in 2023 did not differ much from those shared in 2019.

The global shortage of an active pharmaceutical ingredient (API), manufacturing problems and supply chain problems were named the most by hospital pharmacists.

For medical devices, supply chain problems ranked first, followed by a shortage or discontinuance of a component, part or accessory of the medical device.

Concerning patient impact, nearly two thirds (61%) stressed that they had experienced shortages having an impact on patient care in their hospital. A similar response rate was observed for physicians (59%) and other healthcare professionals (66%). Compared to 2019, the figures did not alter much for these three professional groups. For nurses, the rate of those agreeing with this statement increased in the past 5 years and now 53% of them reported a negative impact on patient care. Delays in care or therapy, suboptimal treatment and cancellation of care were frequently reported as factors that influence patient outcomes.

Over two-thirds of the hospital pharmacists (76%) who responded to this question selected

antimicrobial agents as the area of medicine that is most commonly in short supply in their hospitals.

Analgesics (43%) followed in second place and anaesthetic agents (37%) ranked third. In 2019, oncology medicines – which now ranked fourth – had been in second place and anaesthetic agents in third.

Calls for action put forward by EAHP, which urged the European Commission and Member States to target shortages through a mix of reactive and proactive measures, and to improve communication about them visà-vis hospital pharmacists still remain unaddressed as shown by the results of the 2023 EAHP Shortage Survey. Problems caused by medicine shortages remain serious, threaten patient care in hospitals and require urgent action. To ensure that patients receive the medication they need to improve their health and prevent and cure diseases, EAHP urges policymakers to include the following measures in the revision of the EU’s General Pharmaceutical Legislation: • requiring the creation and regular maintenance of safety plans and risk assessments for manufacturers, • the establishment of multistakeholder task force

teams to perform joint risk assessments, • the provision of information in regularly updated shortage monitoring systems to healthcare professionals, in particular, hospital pharmacists, • incentivising timely sharing of information by companies, e.g. through a reward system or a whitelist, • ensuring in relation to the development of a list of essential medicines that it can be adjusted by countries to serve their national needs, • mandating Member States to set up national task force teams, comprised of national agencies, industry and frontline healthcare professionals like hospital pharmacists that discuss and adopt proactive measures for combatting shortages, • exploring the feasibility of raw material production in Europe for certain products, especially when it comes to products with a high dependency on outside sources, • anchoring the role of healthcare professionals, in particular hospital pharmacists, in the field of compounding, meaning that compounding possibilities to offer adequate patient care should be enhanced.

Understanding Cystic Fibrosis in Children Paul McNally, Consultant Histopathologist, Associate Professor of Paediatrics at RCSI and Consultant in Respiratory Medicine at CHI

Cystic fibrosis (CF) is an inherited disease that mainly affects the lungs and digestive system.

Ireland has the highest incidence of the condition in the world: approximately 1,400 children and adults in Ireland live with the condition and typically more than 30 new cases of CF are diagnosed here each year, usually in the first few weeks of life.

A major new study led by RCSI University of Medicine and Health Sciences and Children’s Health Ireland (CHI) has been awarded funding of ¤5.6M to work with babies and children in Ireland and the UK over the next five years to build a better understanding of cystic fibrosis.

Children born in the 2020s with cystic fibrosis often have more treatment options and potentially better outcomes than those born with the disease in previous decades. But there is still much we need to understand about cystic fibrosis in babies and children in this new era of care.

The ENHANCE study Establishing Natural History in an Advanced New CF Care Era - will be led by the CF research team at Children’s Health Ireland and will be carried out at 13 paediatric (children’s) CF clinic sites in Ireland and the UK. “There is so much to learn about the changes that are happening in children with CF, we are really

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

excited about this new study,” said RCSI’s Paul McNally, who emphasised the importance of working closely with the CF community.

“We spent a long time working with parents of children with CF in Ireland and the UK to understand how best to design the study, as we wanted to ensure we are concentrating on the things that are most relevant to children with CF and their parents in this new era,” he said. “Parents of children with CF and other representatives from the CF community will be part of the study group and help us to ensure that we stay focused on our goals”.

Paul McNally will lead ENHANCE with Jane Davies, a consultant in paediatric respiratory medicine at Royal Brompton Hospital, part of Guy’s & St Thomas’ NHS Foundation Trust and a Professor at the National Heart and Lung Institute, Imperial College London.

Caring for Life, Every Step of the Way At Fresenius Kabi we offer a diverse range of products to meet various healthcare needs. Contact your Fresenius Kabi representative for further information.

Our broad portfolio of healthcare products includes the following: Products

Providing

Enteral

Supporting Patient Recovery

Parenteral

Nutrition for the Critically ill

IV Drugs Oncology

Established Cytotoxics & other IV Drugs

IV Solutions

Rehydration & diluents for IV Drug administration

Biosimilars

Used in some Chronic Conditions

Colloids

Volume Replacement

Medical Devices

Reliable Drug Delivery This is intended for healthcare professionals only.

Fresenius Kabi Limited - Fresenius Kabi Ireland, Unit 3B Fingal Bay, Balbriggan, Co. Dublin, Ireland T: +353 (0)1 8413030 | F: +353 (0)1 8496949 | E: FK-enquiries.Ireland@fresenius-kabi.com | www.fresenius-kabi.com/ie/ Job Code: IE-FK-NPR-2300172 Date of Prep: October 2023

12 HIV

Addressing HIV stigma in healthcare settings in Ireland: Lessons learned from a collaborative study Written by Dr Elena Vaughan, Research Fellow, Health Promotion Research Centre, University of Galway Dr Elena Vaughan is a Research Fellow in the Health Promotion Research Centre in the University of Galway. Her work is focused on HIV stigma, social and structural determinants of health, and right-based approaches to health.

HIV stigma - What’s the problem?

Immense progress has been made in the treatment of HIV in recent years. People living with HIV now have life-spans close to par with HIV negative individuals, and do not transmit the virus once patients have reached the treatment goal of viral undetectablity, commonly referred to as undetectable equals untransmittable or U=U. Despite these advances, HIV-related stigma remains an on-going issue that affects the lives and well-being of many people living with HIV. There is clear evidence that experiences of stigma in healthcare settings have adverse impacts both for the health and well-being of people living with HIV and population health. People living with HIV who experience stigma in healthcare settings often have difficulty trusting healthcare providers, and this can result in health avoiding behaviours. As a consequence, some may put off appointments, delay seeking care, or have poor engagement and retention in care. Such behaviours have obvious knockon effects for the health of the patient. Indeed there is evidence also that experiences of stigma in healthcare settings are linked to poor adherence to anti-retroviral medication (ARVs) and viral non-suppression. Apart from physical health outcomes, Stigma can also affect the mental health.

While stigma can lead to worse health outcomes on an individual level, the barrier to testing, treatment and care caused by stigmatising behaviours, also

has implications for health on a population level. For these reasons, addressing HIV stigma in health settings is a priority prevention goal in efforts to stem the epidemic. Up until recently however, no data on HIV stigma in healthcare settings in Ireland was available.

HIV stigma in healthcare settings in Ireland In 2022, our team in the Health Promotion Research Centre in the University of Galway sought to address that gap by conducting a collaborative mixed methods project involving participation from healthcare workers and people living with HIV in Ireland. Among the aims of the project was to identify key drivers of stigma in healthcare settings, in order to provide a sense of where efforts for intervention may be targeted.

Over 400 people were involved in the research, which included national surveys of people living with HIV and healthcare workers, interviews with a range of stakeholders, and a participative roundtable event to generate recommendations arising from the research findings.

Findings from the survey of 298 healthcare workers, suggested that generally healthcare workers do not hold negative attitudes towards people living with HIV. Rather fear of occupational transmission of HIV appears to be a major driver of stigma in healthcare settings.

For instance, 40% of respondents reported they would worry at least a little about drawing blood, and 29% about dressing a wound of a person living with HIV. Casual contact was not a source of worry for healthcare workers, however approximately a fifth of healthcare workers reported using special measures that they do not use with other patients. This suggests that anxieties around occupational transmission are frequently

translating to stigmatising practices, including double-gloving and use of other unnecessary infection prevention measures.

Indeed this was echoed by several interviewees, including one doctor who observed, ‘You do get people that will say “Oh that patient has HIV, make sure to wear two pairs of gloves.’ Similarly, a nurse who was interviewed remarked, ‘I think that there’s still the “I’d rather stay away from them just in case.” There’s still a fear aspect of getting it.’

Stigmatising practices were also reported by the 89 people living with HIV who completed the survey. Of these respondents, 26% reported having experienced a healthcare worker using infection control measures beyond the usual, 24% reported being told to come back later, put last in a queue or being made to wait until the end of the day, and 20% reported having been denied services. Negative experiences were recounted by interviewees who were living with HIV, with one woman describing the reaction of one healthcare worker: ‘I said “I’m HIV positive” and she just basically jumped out of her seat.’ Stigma experienced by people living with HIV often seemed to additionally be driven by outdated views and a lack of knowledge about HIV. One man described being told by a healthcare worker: ‘I can’t have you in the gym in the hospital because then it will have to be cleaned … so it would be a whole afternoon of no one else being able to use it because you’ve been in.’ The effect of such experiences was also apparent, as two-fifths of respondents reported avoiding care as a result of concern that the healthcare worker would disclose their status to others, and over a half reported avoiding care because of their worry about how they would be treated by healthcare workers.

How can we address the problem?

Fear of HIV transmission was one of the key identified drivers of stigma in healthcare settings in Ireland. While occupational exposure can be extremely anxiety-inducing for healthcare workers, increasing knowledge of U=U, appropriate implementation of universal precautions, and effective communication around the availability and effectiveness of post-exposure prophylaxis (PEP) should help ease healthcare worker anxieties and reduce the

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

prevalence of stigma behaviours in healthcare settings. Targeted, evidence-based messages around U=U may be effective as a relatively low-cost and scalable stigma intervention. We also asked healthcare workers, people living with HIV and service providers in our study how stigma might be reduced in healthcare settings. Suggestions included: emphasising a culture of professionalism, and showing respect and empathy to patients; increasing knowledge of HIV and stigma; leadership from management and senior clinical staff; facilitating opportunities for training and education; and codevelopment and implementation of policies, guidelines and codes of practices.

Addressing stigma to reach the 2030 targets As a member state of the UN, Ireland is committed to the Sustainable Development Goals, of which Goal 3.3 is committed to ending AIDS by 2030. Since 2019, with government support, the cities of Galway, Cork, Limerick and Dublin are also signatories to the Fast-Track Cities Initiative and the Paris Declaration. By signing the Paris Declaration, cities commit to accelerating and scaling up the local HIV responses to attain the UNAIDS 95-95-95 targets for 2030: 95% of People living with HIV (PLHIV) know their status, 95% of people who know their status are on treatment and 95% of people on treatment have an undetectable viral load. The UNAIDS Roadmap for Prevention articulates another set of parallel targets – the 10-10-10 targets – of which one states that by 2030 less than 10% of people living with HIV will experience stigma and discrimination.

Our findings indicate that we have some work to do before these targets will be reached. Armed now however with knowledge of where the issues lie, we have an opportunity to develop stigma interventions that will reduce healthcare worker anxieties and improve patient experiences and outcomes. Changing perceptions and removing the fear of HIV will be of benefit to everyone. As one nurse we interviewed noted: ‘Healthcare staff are going to come across HIV. People live with it now.

Let’s normalise it, you know.’

The full research report is available for download: https://aran.library. nuigalway.ie/handle/10379/17830

This is a promotional advertisement from LEO Pharma for IE healthcare professionals.

For the treatment of moderate to severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy1

TIME TO PRESS PLAY Not an actual patient. For illustrative purposes only. Individual results may vary.

Adtralza®

The first licensed biologic that inhibits IL-13 alone,1,2 a key driver of atopic dermatitis signs and symptoms.3 Learn more at www.adtralza.ie Prescribing Information for Adtralza® (tralokinumab) 150 mg solution for injection in pre-filled syringe Please refer to the full Summary of Product Characteristics (SmPC) (www.medicines.ie) before prescribing.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Indications: Treatment of moderate-tosevere atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy. Active ingredients: Each pre-filled syringe contains 150 mg of tralokinumab in 1 mL solution (150 mg/mL). Dosage and administration: Posology: The recommended dose of tralokinumab for adult and adolescent patients 12 years and older is an initial dose of 600 mg (four 150 mg injections) followed by 300 mg (two 150 mg injections) administered every other week as subcutaneous injection. Every fourth week dosing may be considered for patients who achieve clear or almost clear skin after 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve further with continued treatment every other week beyond 16 weeks. Tralokinumab can be used with or without topical corticosteroids. The use of topical corticosteroids, when appropriate, may provide an additional effect to the overall efficacy of tralokinumab.

Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. If a dose is missed, the dose should be administered as soon as possible and then dosing should be resumed at the regular scheduled time. No dose adjustment is recommended for elderly patients, patients with renal impairment or patients with hepatic impairment.

For patients with high body weight (>100 kg), who achieve clear or almost clear skin after 16 weeks of treatment, reducing the dosage to every fourth week might not be appropriate. The safety and efficacy of tralokinumab in children below the age of 12 years have not yet been established. Method of administration: Subcutaneous use.

The pre-filled syringe should not be shaken. After removing the pre-filled syringes from the refrigerator, they should be allowed to reach room temperature by waiting for 30 minutes before injecting. Tralokinumab is administered by subcutaneous injection into the thigh or abdomen, except the 5 cm around the navel. If somebody else administers the injection, the upper arm can also be used. For the initial 600 mg dose, four 150 mg tralokinumab injections should be administered consecutively in different injection

sites within the same body area. It is recommended to rotate the injection site with each dose. Tralokinumab should not be injected into skin that is tender, damaged or has bruises or scars. A patient may self-inject tralokinumab or the patient’s caregiver may administer tralokinumab if their healthcare professional determines that this is appropriate. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions and warnings: If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of tralokinumab should be discontinued and appropriate therapy initiated. Patients treated with tralokinumab who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination. Patients with pre-existing helminth infections should be treated before initiating treatment with tralokinumab. If patients become infected while receiving tralokinumab and do not respond to antihelminth treatment, treatment with tralokinumab should be discontinued until infection resolves. Live and live attenuated vaccines should not be given concurrently with tralokinumab. Fertility, pregnancy and lactation: There is limited data from the use of tralokinumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of tralokinumab during pregnancy. It is unknown whether tralokinumab is excreted in human milk or absorbed systemically after ingestion. Animal studies did not show any effects on male and female reproductive organs and on sperm count, motility and morphology.

Side effects: Very common (≥1/10): Upper respiratory tract infections. Common (≥1/100 to <1/10): conjunctivitis, conjunctivitis allergic, eosinophilia, injection site reaction. Uncommon (≥1/1,000 to <1/100): keratitis. Precautions for storage: Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light. Legal category: POM. Marketing authorisation number and holder: EU/1/21/1554/002. LEO Pharma A/S, Ballerup, Denmark. Last revised: October 2022 Reference number: REF-22407 Reporting of Suspected Adverse Reactions Adverse events should be reported.

Reporting forms and information can be obtained from: HPRA Pharmacovigilance, Website: www.hpra.ie Adverse events should also be reported to Drug Safety at LEO Pharma by calling +353 1 4908924 or e-mail medical-info.ie@leo-pharma.com

IL, interleukin.

References: 1. Adtralza® SPC. 2. Duggan S. Drugs 2021;81(14):1657–1663. 3. Bieber T. Allergy 2020;75:54–62.

Further information can be found in the Summary of Product Characteristics or from: LEO Pharma, Cashel Road, Dublin 12, Ireland.

E-mail: medical-info.ie@leo-pharma.com ® Registered trademark

Date of preparation: December 2022 IE/MAT-62263

HPRA End of Year Review Embracing a Unified Approach to Shared Challenges Written by Lorraine Nolan, Chief Executive, Health Products Regulatory Authority

collaboration with healthcare and other professionals working in the hospital setting. Throughout 2023, medicines availability has been a key focus area for that interaction.

We look forward to working with the Department of Health and all health stakeholders that have a role in this area, in building greater resilience in medicines’ availability.

Legislative changes to health product regulation

This year was another busy period for the HPRA as it focused on delivering its planned programme of work across each of the health product areas it regulates. As with most years, the HPRA was also faced with managing a wide variety of emerging issues spanning the full spectrum of its regulatory remit. Some of these were familiar developments in the regulatory world, such as adaptations to the way we work due to changes in legislation. Others arose in response to continued advancements and innovation across the sectors we regulate. The year started with a global surge in demand for antibiotics, which brought new challenges in the area of medicines shortages, not only in terms of their numbers, but also the impact on our health system.

Medicines shortages and availability Over the course of 2023, medicines regulatory authorities across the globe reported higher instances of medicines shortages than had been experienced in previous years. This is believed to be the result of a complex combination of multiple contributory factors, including the impact of the COVID-19 pandemic on medicines supply chain resilience, geopolitical events, rising costs, and increasing frequency of major weather events.

The HPRA continued to focus its efforts on initiatives to respond to and mitigate shortages as and when they arise. Additionally, a great deal of work was undertaken to build greater resilience in the medicines supply chain

with a view to identifying and preventing potential shortages before they occur. At a national level, this included the work of the national Medicines Shortages Framework, through which the HPRA coordinates and oversees a multistakeholder response to medicines shortages. At the EU level, the HPRA participates in two groups coordinated by the European Medicines Agency (EMA), both of which have important roles in the monitoring and management of medicines shortages across Europe. As part of this work, the European medicines regulatory network has carried out supply and demand modelling for key antibiotics used to treat respiratory infections in advance of the 2023/2024 winter season. This led to the publication of recommendations for actions to avoid shortages of these antibiotics to ensure sufficient supply to meet the needs of EU patients. Additionally, the network is compiling an EU list of critical medicines, the purpose of which will be to ensure that medicines most critical to EU health systems are available at all times.

Perhaps the greatest strategic opportunity in relation to medicines availability lies in having the capacity to take pre-emptive actions to prevent the occurrence of shortages. With this in mind, the HPRA met with the Minister for Health and his Department and agreed a number of strategic focus areas to build greater resilience in the national supply chain.

The HPRA, across many areas of its work, values its interaction and

Over the course of 2023, we continued to embed new processes arising from changes to legislation introduced in the preceding years. The end of January 2023 saw a significant milestone in the implementation of the Clinical Trials Regulation, as it marked the point at which use of the new Clinical Trials Information System (CTIS) became mandatory. Efforts to strengthen the system brought improvements that supported its users and will help us to realise the aims of the Regulation, including centralisation of key regulatory activities and increased transparency. Further information, including for trial sponsors, is available on the CTIS website: euclinicaltrials.eu In relation to medical devices, it is no secret that implementation of the Medical Devices Regulation and In Vitro Diagnostics Regulation has presented significant challenges. However, a lot has been achieved, and throughout the past year the HPRA continued to work with other EU regulators, industry, healthcare professionals, and patients to explore what is possible within the existing framework and implementing legislation. It is only through unified and collaborative action that we can achieve the aims of the legislation, which is to create a robust, transparent, and sustainable regulatory framework that improves clinical safety and enables availability of state-of-theart treatments for EU citizens.

In April of this year, the European Commission published its proposal to review the EU’s pharmaceutical legislation. The revision, which will be the most extensive update to EU medicines legislation in over 20 years, includes proposals for a new Directive and a new Regulation, which revise and replace the existing pharmaceutical legislation.

Some of the key focus areas of the legislation will be improving access to and availability of medicines,

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

supporting innovation, and tackling antimicrobial resistance. Work is already underway to review the proposal, both nationally and across the European medicines regulatory network. This is with the goal of ensuring the final legislative package helps foster a modern, patient-focused pharmaceutical sector, while also supporting innovation.

Communication and engagement Under the HPRA’s current strategic plan, key areas of focus for the organisation include communication and engagement, as well as health system partnerships. The HPRA is undertaking numerous initiatives to develop its information resources and communication platforms to strengthen its partnership with, and contribution to, the health system. One such initiative that illustrates these efforts is the ongoing project to redevelop the HPRA’s website. As part of this project, the layout of the website will be modernised, with accompanying improvements in readability and accessibility of the site’s content. In tandem, the manner in which the website interacts with the HPRA’s other digital systems will be modified to optimise how information is presented to website users. This is one of the largest projects undertaken by the HPRA in 2023, requiring significant input and collaboration from across the organisation. The outcome will be an improved website that better serves the needs of the HPRA’s diverse range of stakeholders, including professionals working across our hospitals nationally.

Looking ahead to 2024 While we can be certain that many of the developments that emerged in 2023 will continue into the new year and beyond, I look forward to seeing how the HPRA will continue to rise to these challenges and meet them head on. The issues facing regulators are increasingly experienced on a global scale, and it is evident that the strongest approach to shared challenges is a unified approach. The HPRA remains committed to working in partnership with colleagues across the national health system, as well as the international regulatory network, to deliver for the benefit of public and animal health.

Fulvestrant 250mg 5ml

250mg 5ml

Approved for Storage at Room Temperature Fulvestrant EVER Pharma 250mg solution for injection in a pre-filled syringe, is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.

In combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.

No special requirement for storage at 2°C - 8°C - save on refrigerated storage space.

No cold chain transportation - save on transport costs.

Complete with high quality BD SafetyGlide™ Shielding Hypodermic Needle - for enhanced safety.

Consult the Summary of Product Characteristics for the full information.

Name and active ingredients: Fulvestrant EVER Pharma 250mg solution for injection in pre-filled syringe. One pre-filled syringe contains 250mg fulvestrant in 5ml solution. Each ml of the solution contains 50mg fulvestrant. Indications: In adults Fulvestrant EVER Pharma 250mg solution is indicated for the treatment of estrogen receptor positive, locally advanced, or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.

It may also be used in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1 of the SmPC). In pre- or perimenopausal women, the combination treatment with Palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. Dosage and administration: Fulvestrant EVER Pharma should be administered as two consecutive 5ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area). Caution should be taken if injecting Fulvestrant EVER Pharma at the dorsogluteal site due to the proximity of the underlying sciatic nerve. For detailed instructions for administration see section 6.6 of the SmPC. Adult females (including elderly) the recommended dose is 500mg at intervals of one month, with an additional 500mg dose given two weeks after the initial dose. When Fulvestrant EVER Pharma is used in combination with palbociclib, please also refer to the SmPC of palbociclib. Prior to the start of treatment with the combination of Fulvestrant EVER Pharma plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice. Patients with renal / hepatic impairment: Please refer to section 4.2 of the SmPC. Paediatric population: The safety and efficacy of fulvestrant in children from birth to 18 years of age have not been established. Currently available data are described in sections 5.1 and 5.2 of the SmPC, but no recommendation on a posology can be made. Contraindications: Hypersensitivity to fulvestrant or to any of the excipients listed in section 6.1 of SmPC, pregnancy and lactation (see section 4.6 of the SmPC) and severe hepatic impairment (see sections 4.4 and 5.2 of the SmPC). Special warnings and precautions: Fulvestrant EVER Pharma should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2 of the SmPC). Fulvestrant EVER Pharma should be used with caution in patients with severe renal impairment (creatinine clearance less than 30ml/min). Due to the intramuscular route of administration, Fulvestrant EVER Pharma should be used with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment. Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical studies with fulvestrant (see section 4.8 of the SmPC). This should be taken into consideration when prescribing Fulvestrant EVER Pharma to patients at risk. Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection. Caution should be

taken while administering Fulvestrant EVER Pharma at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve (see sections 4.2 and 4.8 of the SmPC). The amount of alcohol in each syringe of this medicine is equivalent to less than 10ml beer or 4ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. To be taken into account in high-risk groups such as patients with liver disease, or epilepsy. Fulvestrant EVER Pharma contains 500mg benzyl alcohol in each syringe which is equivalent to 100mg/ml. Benzyl alcohol may cause allergic reactions. High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis). This medicine contains 750mg benzyl benzoate in each syringe which is equivalent to 150mg/ml. There are no long-term data on the effect of fulvestrant on bone. Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.

The efficacy and safety of fulvestrant (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease. When Fulvestrant EVER Pharma is combined with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib. Due to the structural similarity of fulvestrant and estradiol, fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol.

Fulvestrant EVER Pharma is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see section 5.1 of the SmPC).

Fulvestrant EVER Pharma contains benzyl alcohol. Risk of toxicity is increased in young children due to accumulation. Interactions: A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4. Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance. Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly.

Fertility, pregnancy and lactation: Please refer to section 4.6 of the SmPC. Effects on ability to drive and use machines: Fulvestrant EVER Pharma has no or negligible influence on the ability to drive or use machines. However, since asthenia has been reported very commonly with fulvestrant, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery. Undesirable effects (see section 4.8 of the SmPC for full details): Very common (≥1/10): hypersensitivity reactions, hot flushes, nausea, elevated hepatic enzymes (ALT, AST. ALP), rash, joint and musculoskeletal pain, asthenia, injection site reactions. Common (≥1/100 to <1/10): urinary tract infections, reduced platelet count, anorexia, headache, venous thromboembolism, vomiting, diarrhoea, elevated bilirubin, back pain, vaginal haemorrhage, neuropathy peripheral, sciatica. Presentation: Two clear type I glass pre-filled syringes with bromobutyl rubber stopper, plunger rod and backstop, fitted with a tamperevident closure, each containing 5ml Fulvestrant EVER Pharma. Legal classification: POM. Marketing Authorisation Number: PA1774/006/001. Distributed by Athlone Pharmaceuticals Limited. Date of preparation: October 2023. IE23/003/SmPC August 2022.

Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie) or by email medsafety@hpra.ie Adverse events should also be reported to Kent Athlone Pharma Group on (090) 666 1109 or medical@kent-athlone.com. Additional information available on request.

For further information on this product, please contact Gavin Butler, Key Account Manager, Athlone Pharmaceuticals Ltd., Connaught House, 1 Burlington Road, Dublin 4, Ireland.

Tel: + 353 (0) 9066 61109 | Email: customer.service@kent-athlone.com

Date of preparation: October 2023 Ref: IE2023/005/00

Prescribing information

IHCA End of Year Review Care Can’t Wait – IHCA Look Back on 2023 Professor Rob Landers, President, IHCA

The Irish Hospital Consultants Association (IHCA) welcomed in the new year by expressing its concern over the continued pressures being faced by Ireland’s acute hospital services as extreme levels of overcrowding in emergency departments and un-safe capacity limits hit record new highs.

Commenting, a spokesperson for the IHCA said, “The Irish health service is once again the focus of public, political and media attention. The level of coverage of individual and collective experiences from within our hospitals over the past number of weeks is only comparable to that of the start of the Covid-19 pandemic.

It is not inconceivable that we could see 1,000 admitted patients being treated on trolleys on a single day in the weeks ahead.

“Public hospital staff are working tirelessly attempting to provide appropriate levels of care to patients. Consultants are on call 24/7, often practising over and above recommended levels, but the reality is there simply aren’t enough of us to meet increased demand. We are still working with 40% less Consultant staffing in Ireland, compared to the EU average.”

By February, they warned that the ongoing shortage of Consultants across Cork hospitals and unaddressed bed capacity deficits, were restricting patients from accessing timely, high-quality medical and surgical care. The six hospitals in the Cork region1 saw 2,300 additional people added to their waiting lists for outpatient appointments and procedures in 2022 – a increase of almost 3%.2 This compares with a modest reduction of 5% (-7,800) in the

number of people on the three main waiting lists under the Government’s Waiting List Action Plan3 across the wider South/South West Hospital Group (SSWHG), and a 4% (-28,900) fall nationwide, meaning the Plan missed its key targets in the region.

The Association launched a new video this year, as part of their ‘Care Can’t Wait Campaign. Active since June 2022, the campaign highlights the consequences of the shortage of hospital consultants and public acute hospital beds.

In the new video, Airline Captain Niall Downey, a former Cardiothoracic Surgeon, said the Government should implement an aviation style safety model when it comes to healthcare.

Captain Downey said a ‘name, blame, shame, retrain’ culture within our health service is placing extra strain on healthcare workers who are already facing immense pressure. He added that consultants and other healthcare workers should feel safe in identifying risks and where mistakes have been made, in order to develop a system where health service management can assess “what went wrong, not who went wrong.”

“In aviation we assume we are going to get it wrong, and all our systems are designed around that. We expect error, we don’t blame the individual for that. We have reporting systems where we can speak up without the fear of disciplinary action or dismissal. It’s called a Just Culture,” he said.

In a bid to help combat the serious issues being faced by Ireland’s health service, the Association recommended

“Without the required funding to rapidly address the fundamental shortage of acute hospital beds, theatre capacity and other facilities the challenges in delivering timely care will continue to escalate.”

The Government commit the estimated ¤4 billion in capital funding needed to build and open essential hospital improvements already announced by the Minister for Health that promises to significantly increase the number of acute hospital beds and theatre capacity in our hospitals.

In its Pre-Budget Submission 2024, published in July, the Association said a minimum of 5,000 additional public hospital beds should be funded and opened by the end of 2030 – or 700 extra hospital beds each year for the next seven years. This must start with the rapid delivery of the 1,500 acute beds the Minister for Health Stephen Donnelly committed to open across 15 hospital sites in 2023 and 2024 at a cost of ¤1bn.

However, in October, following publication of the Budget 2024, they expressed concern that is has not provided the necessary capital funding to build and open the additional acute hospital beds and theatre capacity in our public hospitals already announced by the Minister for Health.

The Association had estimated that ¤4bn could be required for the long promised four elective

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

hospitals, six surgical hubs, and the 1,500 rapid build public hospital beds that Minister Stephen Donnelly promised to open across 15 acute public hospital sites in 2023 and 2024.

Instead, Budget 2024 has allocated ¤1.23bn in capital funding for Health next year, which is just ¤70m more than the allocation in 2023. Consultants say this will not result in the opening of the 1,500 additional rapid build hospital beds, six surgical hubs and four elective hospitals promised by the Minister for Health, and therefore will not address the demographic factors increasing the demand for care that is growing year on year.

Professor Rob Landers, President of the IHCA, says, “Regrettably Budget 2024 will not adequately address the overwhelming capacity deficits in our acute hospital and mental health services, especially the severe shortage of public hospital beds, theatres, and other frontline facilities, which are urgently needed to provide timely, safe care to patients.

“The four new elective hospitals have been promised since Sláintecare in 2017 but have not been opened or advanced as expected. In addition, the six surgical hubs proposed in December 2022 remain as far away as ever, and the 1,500 rapid build hospital beds announced by the Minister in April are nowhere to be seen.

“Without the required funding to rapidly address the fundamental shortage of acute hospital beds, theatre capacity and other facilities the challenges in delivering timely care will continue to escalate.”

References 1. The six Cork Hospitals are: Cork University Hospital, Cork University Maternity Hospital, Mercy University Hospital, South Infirmary Victoria University Hospital, Bantry General Hospital, and Mallow General Hospital.

2. Latest NTFP data as at end December 2022: https://www. ntpf.ie/home/nwld.htm.

3. Waiting List Action Plan, 25 February 2022: https://www.gov. ie/en/publication/323b5-the2022-waiting-list-action-plan/.

Asthma Society of Ireland Our Year in Review Our vision in the Asthma Society of Ireland is that everyone with asthma lives a full life, symptomfree. Our mission is to reduce asthma deaths and transform the lives of people with asthma.

In 2023, our 50th year, we continue to support people with asthma, parents, carers, health care professionals, teachers and special needs assistants. We learn together and collaborate with healthcare, research and educational professionals to improve our understanding of how asthma works and how to combat it. The Asthma Society contributes at every level of health care – GP, integrated care, secondary and tertiary care working closely with the National Clinical Programme Respiratory (NCPR).

Although the pandemic is over, COVID19 continues to remain a challenge along with influenza and RSV for people living with chronic respiratory conditions including asthma. The impact of this is reported to us daily on our two patient support services WhatsApp nurse messaging and Adviceline service. Other issues highlighted through these services are, the cost of living crisis, inflation and difficulties accessing a GP. Patients might not attend the GP or buy their asthma medications due to financial constraints. The energy and cost of living crisis also impacts on our patients with chronic respiratory disease who require oxygen or nebulized medication. These issues result in increased morbidity and the need to use health services.

Patient Services Our patient services consist of Asthma/COPD Adviceline, and the WhatsApp nurse messaging service part of which is the webinar series. We also support Healthcare professionals with resources in the form of written and electronic resources. In addition the website is very often the first port of call for clients seeking information on their condition.

of their disease management, get signposted to key respiratory health management tools, further understand their disease and to be referred onwards. Service learnings indicate that once-off usage of the WhatsApp messaging service is effective but builds in impact when patients return and use it repeatedly. In the first 3 quarters of 2023 the WhatsApp service conducted over 3000 interventions for 315 clients.

Written by Ruth Morrow, Respiratory Nurse Specialist, Asthma Society of Ireland

Webinars Webinars are held regularly to support self-management and provide education to patients, carers and healthcare professionals. Expert speakers present on topical subjects alongside an ASI respiratory nurse followed by a Q&A session.

Subjects this year included: Living well with asthma and COPD, Seasonal Allergies and Asthma, Asthma Care for All, Asthma and Anxiety, Back2School for parents, carers, teachers and SNAs and Winter Wellness. Between 200 and 300 people registered for each webinar and on average 130 attended. People can avail of recordings to watch back on our website .Post webinar surveys show improvement in knowledge and 100% of registrants say they would recommend our WhatsApp/ Adviceline service to a family member, friend or colleague.

Asthma Adviceline: 1800 44 54 64 The aim of the Adviceline is to provide education, selfmanagement skills and healthcare signposting by providing upto-date, expert information and advice. It is a free call back service available to people with asthma and their carers. Clients can book a 30 minute consultation with an asthma nurse and will be followed up with further calls as needed. The asthma Adviceline has been in existence for many years with numbers using it increasing every year.

WhatsApp Nurse messaging Service: 086 059 0132

Chronic Obstructive Pulmonary Disease (COPD) Adviceline: 1800 83 21 46

This nurse-led service allows patients with asthma and/or COPD, their family and carers, to confidentially message a respiratory nurse about all aspects

The COPD Adviceline is provided in collaboration with COPD Support Ireland and the HSE. It is a free callback service for people who want to learn more

about COPD. It can help support people to better understand their symptoms and manage their condition. Patients are linked into COPDSI services and support groups. This service is available to all people with COPD, family members and carers of people with COPD as well as healthcare professionals who support people with COPD The Asthma Society celebrates 50 years In this, our 50th year we aim to celebrate achievements and milestones. We hope to raise awareness of the Asthma Society and create a platform for relationship building with stakeholders. Along with this the Asthma Society wants to generate recognition of its value in addition to recognizing those who have contributed to our achievements. Most importantly this is a time to think about the future and the Society’s role and purpose. A celebration takes place at the end of November with invited political representatives, corporate partners, health care professionals, board members, government bodies, and our asthma ambassadors. This event will bring recognition through attending media and social media contacts. An exciting agenda hosted by Matt Cooper includes the Minister for Health Stephen Donnelly and Ronan O Gara Irish former rugby union player. The agenda also includes fundraising and award giving Asthma Awareness Week Asthma Awareness Week took place during the first week of May.

As part of this, the Asthma Society conducted a survey amongst 1,294 men and women aged 18+ living with asthma. This survey revealed the concerning decisions people with asthma and their loved ones have been forced to make during the cost-of-living crisis. Despite 96% of those surveyed being prescribed asthma medications, 45% have had to forego them in the prior three months due to financial constraints. Other findings showed: • 48% of households with asthma have been in arrears on mortgage or rental payments; utility bills; hire purchase instalments or other loan payments in the past 12 months.

• 76% also said that their own or their child's daily activity was limited or severely limited by the disease.

• 25% of survey participants described their asthma as bad or very bad.

• A virtual conference entitled Asthma Care for All was hosted and featured people living with asthma describing their own experiences of being treated for asthma and the difference the Asthma Society has made to their lives.

Hayfever Campaign This year the Asthma Society conducted a very successful Hayfever campaign. The launch coincided with Asthma Awareness Week and included a very highly attended webinar on Asthma and Allergic Rhinitis. Every opportunity was taken to promote the pollen

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

Asthma Society of Ireland continued tracker available on our website and to share expert advice on managing this condition. A top tips release with practical tips was shared with key broadcast, print and online media. Numerous national and regional interviews took place with Respiratory Nurse Specialist Ruth Morrow and Prof Marcus Butler as well as sharing the personal stories of patients with asthma who experience severe hayfever symptoms. The campaign continued throughout the summer months.

Asthma Safe School Programme The aim of this program is to train one teacher per school in PHECC (Pre Hospital Emergency Care Council) approved and certified basic life support and administration of Salbutamol for emergency treatment of adults and children with an acute asthma attack. This year funding was available from CHO 3, 7 and 9. A total of 83 applications were received across the three CHO areas.

This program enables school staff to identify what to do in the case of an acute asthma attack, to encourage schools to provide a supportive environment for

students with asthma, to create better public awareness of the 5 Step Rule and how to recognize and manage an asthma attack.

Part of the programme included an Asthma Safe School webinar, free for all principals, teachers and SNAs in May 2023 that was viewed by 172 people.

• Invest in severe asthma medication

A post program survey showed 97.37% said they were aware of the 5 step rule and almost 90% agreed that they had been provided with the training and tools to provide a supportive and safe environment for pupils in school. One participant noted “Excellent information and should be rolled out nationally”.

• Improve Air Quality in our Homes and Communities

Pre Budget Submission

This campaign is in its second year and is our flagship fundraising event. The Asthma Society depends hugely on fundraised income to achieve our goals of everyone with asthma living a full life, symptom-free and reducing asthma deaths. The ‘Take a Breath’ campaign carried out in September invited participants to compete as a group or as an individual to hike/walk to raise funds for the Asthma Society. This was highlighted and promoted through the member’s newsletter, collaboration with influencers

The 2024 pre-budget submission released at the end of September had seven budgetary asks focused on preventing asthma deaths in Ireland, improving quality of life for 380,000 people in Ireland with asthma, and reducing the cost of asthma to both the state and the individual.

The Asthma Society’s Seven PreBudget asks include: • Universal Subsidisation of Asthma Medications

• Extend the current Asthma Management Programme to all people with asthma • Increase Capacity in our Healthcare System: Recruit Respiratory Specialists

• Disincentivise smoking and e-cigarettes through taxation • Restore pay parity within the Community and Voluntary Sector Take A Breath Fundraising Campaign

and through our social media channels. The Asthma Society is enormously grateful for the participation particularly of our asthma ambassadors. Thanks to all involved we met our fundraising targets this year. We hope to build on this and exceed the targets for next year.

Conclusion This year the Asthma Society has celebrated 50 years. Although this was an opportunity to look back, the Asthma Society is concentrating on the future. We hope to reach out further to those who need our services and build relationships with stakeholders.

Along with patient services the Asthma Society will build on its advocacy and research work to meet the needs of people with asthma. We also look forward to implementing the fundraising strategy that will provide the resources to expand and grow to serve the 380,000 people living with asthma in Ireland.

Acknowledgments The author would like to acknowledge the help of Mary McDonald, Patient Services Manager and Caroline Reilly, Patient Services Coordinator for their assistance with this article.

C

M

Y

CM

Asthma News

MY

Asthma Society Reaction to Budget 2024

CMY

CY

household costs, such as putting food on the table, and the purchase of their essential medications.

The Asthma Society of Ireland, now in its 50th year of impact, has reacted to Budget 2024.

The Asthma Society is focused on preventing asthma deaths in Ireland, improving the quality of life for almost 400,000 people in Ireland with asthma, and reducing the cost of asthma to both the State and the individual.

Affordability of medication Speaking about the need for affordable asthma medication, CEO of the Asthma Society of Ireland, Eilís Ní Chaithnía, said, “It is disappointing not to see asthma medication prioritised in Budget 2024. In our PreBudget Submission, the Asthma Society of Ireland called for

a substantive move towards universal subsidisation of asthma medication in this year’s Budget by making ‘combination’ inhalers free to people with asthma.

International research has found that combination inhalers when taken daily to keep asthma symptoms at bay, reduce the risk of asthma attacks and unscheduled GP and hospital visits, and reduce the cost of asthma to the State.

“Investment in the right medication makes sense. Asthma medications, when used properly, are a reliable and cost-effective way of managing asthma. Amid this cost of living crisis families across Ireland are being forced to choose between

“No one should forgo life-saving medication due to cost barriers.

We have been fighting to have asthma included under the long-term illness scheme since it was first introduced in the 1970s.

Although it has not been included as part of today’s budget, we will continue to fight for affordable medication to be made available free of charge to the 380,000 people in Ireland.”

Smoking and Vaping Speaking about the price of cigarettes and disincentivising smoking and using e-cigarettes, she continued, “In our prebudget submission, we called for a 50 cent increase on the cost of cigarettes along with new taxation measures on all nicotine and tobacco-inhaling products.

We are pleased to hear that the Government has listened to these calls and increased the price of cigarettes by 75 cent per packet.

“And whilst we commend Minister McGrath’s recognition that a

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

K

tax on e-cigarettes is needed, it is disappointing that it will be postponed to next year. 11% of our young people under 25 years of age are using e-cigarettes and action is urgently needed to limit their detrimental health impacts.

Inhaling these aerosol products - even through passive exposure - has been shown to negatively impact respiratory health among adolescents and are shown to significantly worsen asthma symptoms.”

Eilís added, “Clean Air has been central to the work of the Asthma Society for a number of years.

It is a positive move that the Government has taken some of our Budgetary calls on board such as the increase in Carbon Tax by 7.50 per tonne as well as the extension of vehicle registration tax (VRT) relief for electric vehicles.

However, it is disappointing that there was no corresponding increase in VRT for high-emission cars. It is also disappointing that increased funding for the Warmer Homes scheme was not targeted towards people with underlying health conditions such as asthma.”

End of Year Review: HIQA Engaging and Working with Stakeholders Written by Angela Fitzgerald, HIQA, CEO

In 2023, as we emerged from the COVID-19 pandemic, we witnessed unprecedented challenges for those providing care in terms of meeting additional emergency and elective demands.

Key drivers included unmet need as a result of the pandemic, coupled with pressures from demographic factors primarily associated with population growth, ageing and movement.

On behalf of the Health Information and Quality Authority, I acknowledge the extraordinary efforts by staff in health and social care settings during the pandemic and beyond to meet the needs of people using services.

However, there is no doubt that there has also been a significant impact on staff arising from these sustained efforts in terms of fatigue and overall resilience. In terms of patient and service user experience, it is also important to acknowledge that these combined challenges have also had an impact on those using health and social services in terms of timely access and safe effective care.

HIQA was established in 2007 to drive high-quality and safe care for people using health and social care services in Ireland.

Our remit is rapidly expanding

and our approach to regulation and inspection has evolved over time. In the 16 years since our establishment, we have gained pace in how we develop standards, inspect and review health and social care services, and support informed decisions on how services are delivered through our work in evidence synthesis and health information. For example, our work in the area of providing evidence synthesis has become increasingly important as Government seeks to address competing demands between new health technologies and treatments.

In our approach to regulation, we have sought to be fair, proportionate and accountable.

At the same time, we are very mindful of the imperative for HIQA to continue to be an advocate to ensure that the safety and welfare of all service users is promoted and safeguarded.

There are also a number of important developments happening in the regulatory landscape. Earlier this year, the President signed the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 into law. This will bring new responsibilities for HIQA, including the expansion of our remit into private hospital

services, a requirement for all hospitals to report notifiable incidents to HIQA and an extended remit in relation to investigating individual adverse events in nursing homes. This is an important step in supporting the development of an open culture in health and social care services and enabling learning when things go wrong. Also, as many patients move between public and private care settings, this new legislation will provide a common regulatory framework to support standardisation of care.

Over the past year we have also been preparing for other new significant areas of work, namely new functions under the Human Tissue (Transplantation, PostMortem, Anatomical Examination and Public Display) Bill 2022, the monitoring of international protection accommodation services and the regulation of homecare services. The regulation of homecare services will support the safe management of individuals wishing to stay, and age, in their own homes, which we hope will also have an associated positive impact on demand for hospital services. We are working closely with the Department of Health to inform the development

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

of a Health Information Bill, which aims to ensure that Ireland has a fit-for-purpose national health information system. While our remit continues to expand, our vision remains the same; Safer Services and Better Care for All. A key objective for HIQA in delivering on our vision is to engage and work collaboratively with our stakeholders and use their feedback to inform our approach. These new regulatory roles and functions will require the development of new relationships to deepen our understanding of the operation of both public and private health and social care services. It also offers us an exciting new challenges as a regulator to extend national standards for safer better care to new services. We are committed to supporting health and social care providers to meet their regulatory requirements and will continue to engage with hospitals and other healthcare services in preparation for these new legislative changes.

These new areas of work will place additional emphasis on another core value; promoting and protecting human rights. We know that for those who use our services, this is a fundamental principle when accessing healthcare services. We will continue to focus on this into 2024 and beyond, continuing to promote human rights as well as identifying, challenging and reporting on breaches of rights in health and social care services.

As the regulator, it is also important that we are proportionate, fair and accountable in the exercise of our legal responsibilities, and that we advocate for change on behalf of both providers and those using our services, where appropriate.

Our inspection reports are an important tool in both identifying what is working well and where improvements are needed. In 2023, a consistent finding through our inspection activity across both health and social care is the importance of good governance and management. We continue to highlight that well-governed and managed services enable better outcomes for people using them.

Our inspections of emergency departments demonstrate that

good operational capability and internal processes enable the efficient functioning of emergency departments to reduce overcrowding, support effective patient flow and ensure safer services for patients. Therefore, we will continue to seek to drive improvements in the quality and safety of care through responsive leadership, operational management and effective governance at local and regional levels. Our inspections also amplify the critical importance of patient safety in healthcare settings, particularly in those settings where emergency care is delivered. We continue to emphasise that the effective identification, monitoring and management of patient safety risks associated with overcrowding in emergency departments is a key area for both immediate and longer-term attention.

A core requirement in addressing patient safety risks is having adequate capacity both in acute and community settings to meet service need in a timely way.

Through the publication of our individual hospital and overview reports, we have highlighted the importance of delivering on immediate and medium-term capacity requirements across the healthcare system. We have sought to extend the discussion on capacity to whole-system solutions and responses. Finally, we identified the importance of

strategic workforce planning which anticipates and manages temporary and structural staffing shortages as a critical success factor in delivering safe, effective care.

Through this work, we continue to advocate on behalf of patients and the public with the aim of achieving sustained improvement in terms of access, safety and quality. As we move into 2024, we will continue to amplify the key priority investment requirements needed in overall capacity, as well as focusing on improved internal capability required to enable sustained improvements.

The links between residential and acute care are significant, with challenges in one area impacting on another. Throughout 2023, HIQA’s Chief Inspector, who is responsible for the regulation of designated centres including nursing homes, used her regulatory powers to support and influence the delivery of safe and effective services in nursing homes. During the year, we worked collaboratively with the HSE and private nursing homes to support the safe and effective discharge of older people from hospitals to the nursing home of their choice by prioritising the registration of new beds within the sector and by enabling increased planned discharges on a seven day basis.

Similarly, the inspection process seeks to promote the principle of

maintaining older people’s care and safety within their nursing home where possible and only requiring transfer to hospital when absolutely necessary.

In this context, we engaged collaboratively with service providers during the year to ensure that they make the required resources available to ensure that they can deliver the appropriate care for their residents. As Ireland moves towards the establishment of integrated health and social care regions, we are committed to working to ensure that our approach to regulation supports the delivery of integrated care, within and across these settings.

Another example of how we work collaboratively is our National Care Experience Programme.

This is a powerful collaboration between HIQA, the HSE, the Department of Health, and patient advocacy groups, where we listen and respond to people using services through national surveys. For example, the National Inpatient Experience Survey has provided important feedback on how patients experience hospital services, allowing for improvement opportunities to be identified and actioned at individual hospital and national level.

the end-of-life care provided to their loved ones in the last days and months of their life. The results will be published in 2024, and we hope that our findings will provide valuable information on the standard of care provided at end of life, will show what is working well and highlight areas where improvements are required. Earlier this year, we also published the results of Ireland’s first National Maternity Bereavement Experience Survey, which asked women and their partners about their experiences of maternity bereavement care in an Irish maternity hospital or unit after a pregnancy loss or perinatal death. These surveys aim to help us understand the standard and quality of care so that improvements can be made. To date, all our surveys have found that the vast majority of patients and service users have positive experiences, but there are opportunities for improvement, notably in the areas of communication about their care, having time to talk to professionals about worries and fears and input to decisions about care. We are fully committed to driving change through the findings of these surveys.

In March 2023, we launched the National End of Life Survey – the first national survey to ask people who have been bereaved about

I look forward to 2024 and the opportunities that lie ahead for HIQA as our role continues to evolve.

News Illuminating heart health on World Heart Day 2023 Croí, the heart and stroke charity, was delighted to collaborate for a second year with some of the most iconic and historic buildings, organisations and landmarks throughout the west to celebrate World Heart Day on 29th September 2023.

World Heart Day is a reminder to everyone around the world to take care of their hearts. This year’s World Heart Federation campaign focuses on the essential message of knowing our hearts first, because when we know more, we can take better care.

The illumination of The Galway Hooker, last year, docked at the Claddagh basin was a sight that brought much attention to the campaign, and encouraged many more organisations to come on board for this year’s illumination.

The illumination campaign draws a close on the many events organised by Croí throughout September in recognition of World Heart Month. Details of events can be found on www.croi.ie Croí not only encourages people to ensure their heart health is a priority, but also those around them, friends, family, and colleagues. Croí’s aim is to educate and empower individuals, families, and communities to take control of their heart health and to make and maintain the changes that can lead to a longer and healthier life. Croí would like to extend thanks to the public, the many healthcare professionals, organisations, and volunteers who worked to ensure World Heart Month was an outstanding success.

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

A Year of Achievement Marked by Irish Cancer Society Averil Power, CEO, Irish Cancer Society

their cancer ‘forgotten’ by the insurance industry after 5 years’ remission. For adults, there is a 7-year waiting period.”

In October, people across the country were urged to host a Big Pink Breakfast to support the Irish Cancer Society’s vital breast cancer support services and lifechanging research. The campaign encouraged people to host a Big Pink Breakfast in their homes, workplaces, communities and colleges to raise funds to support breast cancer support services such as free counselling, transport to chemotherapy, Night Nursing and much more. Funds raised will also be used to fund ground-breaking breast cancer research projects.

A milestone development for the Irish Cancer Society took place during the first half of this year, as they announced their partnership with the Trinity St James’s Cancer Institute to fund new programmes integrating scientific discovery with patient care to pioneer novel ways to prevent, detect and treat cancer - in particular to address the rise in the incidence of gastrointestinal cancers among patients under fifty years of age.

The five-year collaboration will see the Society invest ¤4.5million in several specific exemplar programmes aimed at delivering a new model of cancer care for patients in Ireland.

By investing in the Trinity St James’s Cancer Institute (TSJCI) the Irish Cancer Society aims to accelerate the translation of cancer research into new treatments and better support for patients.

“The combined number of missed cancers from 2020 and 2021 tell us that 1 in 12 expected cancers were not detected over the first 2 years of the pandemic. We don’t yet have the full picture of whether these cancers were diagnosed at a more advanced stage, but what we do know is that the later the stage of diagnosis, the more complex, more costly, and more invasive cancer is to treat.”

Following publication of a report by the National Cancer Registry of Ireland (NCRI) and funded by the Irish Cancer Society in June, which showed there was a drop in the number of cancers diagnosed during the first two years of the pandemic, Rachel Morrogh,

Director of Advocacy at the Irish Cancer Society voiced their fears that Ireland has encountered a second year of fewer cancers being diagnosed. “Cancer never went away during the pandemic but remained undetected due to a range of reasons including disruption to health services, people putting off seeking medical advice, and possibly premature death from Covid,” she said.

At the start of the summer, the Society welcomed the publication of the Code of Practice for cancer survivors seeking mortgage protection insurance

by Insurance Ireland. The Code of Practice should make it easier for cancer survivors to get mortgage protection insurance and the industry says it should be operational before the end of the year.

Rachel Morrogh, Director of Advocacy at the Irish Cancer Society responded to the publication of the Code of Practice by saying, “The Irish Cancer Society welcomes the announcement that the insurance industry has published a Code of Practice that will make it easier for cancer survivors to get mortgage protection insurance.

“We are delighted that the Irish Cancer Society’s campaign on this issue has led to a positive outcome for cancer survivors, particularly survivors of childhood cancer whose diagnosis could follow them well into adulthood.

The Code of Practice means that anyone who was under 18 at the time of diagnosis will have

The Irish Cancer Society welcomed Minster Roderic O’Gorman’s announcement this year that he will legislate to enable women with cancer to defer their maternity leave until their treatment ends. The need for change was highlighted by the Irish Cancer Society’s ‘Leave Over Leave’ campaign.

Averil Power, CEO responded to the announcement by saying, “The Irish Cancer Society’s ‘Leave Our Leave’ campaign highlighted the distressing impact this is having on women and their babies.

Having met Minister O’Gorman a few months ago to discuss our campaign, I am delighted to hear he plans to bring a bill to Cabinet before Christmas to enable women undergoing treatment for serious illness to postpone maternity leave until their treatment ends.

We commend the Minister for prioritizing this area; it will make a huge difference to women and their babies.

“I’d also like to thank the many women and their families who have supported the ‘Leave Our Leave’ campaign, especially Erica Tierney, Mary Canavan and Emma McGuinness. By bravely sharing their stories, they have highlighted how awful it is to go through cancer while pregnant or with a young baby and how cruel it is to be unable to postpone your maternity leave until you are better.

Thanks to them, when this change is implemented, other women will be spared that heartbreak.”

More recently, the Society has voiced concerns that underfunding cancer services in this years Budget would be at a great cost to cancer patients.

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

“Cancer services require ¤20 million in extra funding in Budget 2024 to secure better survival rates and quality of life for people with cancer", Irish Cancer Society CEO Averil Power.

“There is a real risk that cancer outcomes will go backwards if reduced spending, squeezed supply and increased demand on cancer services continues. The Irish Cancer Society is concerned that if cancer is not a priority for Government and that if the National Cancer Strategy does not receive the ¤20m in funding it needs, that the price paid by patients will be poorer outcomes and reduced services and support for them.

“The Irish Cancer Society would like some of the ¤20m funding to go towards the roll-out of a successful pilot we initiated called ‘chemo in the community’. We are also calling for investment in the Acute Oncology Nursing Service which allows cancer patients to avoid ED when it’s clinically appropriate. This would reduce distress for patients, decrease the risk of them picking up an infection and reduce the pressure on overstretched ED departments.

“Urgent action is also needed to address the impact of the cost of living crisis on cancer patients and their families. The financial impact of cancer is huge. The patient themselves is usually out of work for a period, while a family member may also have to take time off to care for them. At the same time, they are hit with a wide range of extra charges. In last year’s Budget the Government abolished inpatient charges following a public campaign by the Irish Cancer Society. This saving of up to ¤800 per year for cancer patients was very welcome. However, the cost of living crisis means that patients are increasingly struggling with other costs such as hospital parking fees.

“After three years of exceptional pressure on our cancer services, cancer patients, and the staff who care for them, are particularly vulnerable at this time. Cancer is not just a Department of Health, HSE or National Cancer Control Programme issue. The needs of cancer patients and their families deserve the attention of every member of Government and every elected representative”, Ms Power concluded.

Individualised care for every patient… it’s in our DNA

Championing patient support within the community Here at Fresenius Kabi, we understand that there is no ‘one size fits all’ when it comes to homecare for parenteral nutrition. That’s why we are dedicated to providing individualised care for each patient, so that they can start to regain independence and take control of their nutritional needs.

Home parenteral nutrition (HPN) can help to provide patients, who cannot meet their nutritional needs through enteral nutrition, with the nutritional support they need in their own home. A life-sustaining therapy, HPN enables a greater level of patient independence and reduces the financial burden of in-hospital care on the healthcare system.1,2 Fresenius Kabi, providing life-sustaining therapy at home from more than 20 years.

References: 1. Pironi L, Boeykens K, Bozzetti F et al. ESPEN guideline on home parenteral nutrition. Clin Nutr. 2020;39(6):1645–1666.

2. Rice N, Dowsett J, O’Hanlon C. IrSPEN Special Report No 1: A review of home parenteral nutrition in Ireland: recommendations for action. IrSPEN’s Standards and Guidelines Committee, Ireland. 2013. © Fresenius Kabi Ireland. Job code: XXXXXXX. Date of preparation: April 2022 Fresenius Kabi Limited. Fresenius Kabi Ireland. Unit 3B Fingal Bay Business Park, Balbriggan, Co. Dublin, Ireland.

Phone: +353 (0)1 841 3030 Email: enquiries.Ireland@fresenius-kabi.com

End of Year Review: Crohn’s & Colitis Raising Awareness of Crohn’s and Colitis This year has been an exceptionally busy year for Crohn’s & Colitis Ireland! It has been filled with a lot of very exciting projects and initatives, and some of the highlights are outlined below.

Written by Amy Kelly Head of Communications and Fundraising

Crohn’s & Colitis Ireland launched a new campaign as part of World IBD Day called the “Poo Taboo” which aims to encourage people to recognise Crohn’s Disease and Ulcerative Colitis symptoms, and not be embarrassed to get checked out. The campaign featured a symptom checker were in just 30 seconds the respondent would know what to do, including whether to contact their GP and what symptoms to highlight during the appointment. Within the first 3 months of the symptom checker the response rate had exceeded the initial target with 12,999 responses. 96% of respondents, 12,444, were told to speak with their GP in the next few days as they were experiencing IBD symptoms. From the campaign IBD was mentioned in over 90 various media outlets in May 2023, including national radio, tv, and print, digital, podcasts and local radio and print. This campaign was supported by AbbVie and Pfizer.

• Financial burden on IBD patients

The final session of the day is a panel discussion that look at how patients can have more frank and open conversations with their doctors and look for a more sustained long-term treatment for their disease.

• Childhood, adolescent, and transitional to adulthood care

Speakers from our Cork Patient Day included:

• Recruitment of further support including psychologists and Dietitians

• Prof. Subrata Ghosh - Chair and Head of Medicine at UCC and Deputy Director of the AP.

“CCI Connect” Support Groups

• Kathleen Sugrue - Advanced Practice Provider in IBD, The Mercy

Raising Awareness in Dáil Éireann

We travelled around country from Dublin to Cork, Galway and will be in Letterkenny in November with our patient days. These days feature information sessions provided by the IBD team on topics such as flare management, how to get most from your appointments, explaining IBD and more.

Launch of CCI’s “Poo Taboo” Campaign

Thursday the 25th of May, Crohn's & Colitis Ireland presented to TD's and Senators in Leinster House in Dublin on what it is like to live with IBD in Ireland and the support we need to live well.

Speaking on the panel was: • Prof. Colm O’Morain HSE/ RCPI Clinical Lead in Gastroenterology & Hepatology.

Emeritus Professor of Medicine, Trinity College Dublin.

Gastroenterologist, Tallaght University Hospital,

• Access to diagnostic testing and new treatments • Long-term Illness Scheme recognise IBD as a lifelong illness

Going through a diagnosis of Crohn's or Colitis can often be a difficult journey. Although friends and family can be hugely supportive and do their best, there is nothing like chatting with someone else who lives with the condition.

This year we launched "CCI Connect", an online members-only support group. The online support group meet every two months and is an informal space, giving an opportunity to connect with other people living with Crohn's & Colitis in Ireland from the comfort of their own home.

CCI Patient Days

The day also feature a networking lunch, where participants have the opportunity to meet others who live with IBD.

• Aideen Stack - Health Psychologist and IBD patient • Aoife Walsh - Former Miss Ireland and IBD patient • Angela Mullen - Crohn’s and Colitis Nurse Specialist, Cork University Hospital • Clodagh Byron - Clinical nurse Specialist Inflammatory Bowel Disease, Cork University Hospital Speakers from our Galway Patient Day included: • Áine Keogh, Advanced Nurse Practitioner in IBD, Galway University Hospital • Dr. Richéal Burns, Lecturer in Health Information Technology, Department of Health and Nutritional Science in ATU Sligo • Jonathan Healy –Lives with Crohn’s Disease and with a stoma Croke Park Abseil On the 19th of August, braves heros from around the country took on the challenge of abseiling

• Mary Hamzawi, Clinical Nurse Specialist, St. Vincent’s Hospital & Crumlin Hospital, • Victoria Spillane, CCI Board member and IBD patient • Amy Kelly, Head of Communications and IBD patient, CCI. The team highlighted the problems that people with IBD in Ireland face including: • Route to diagnosis and A&E admission DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

from the top of Croke Park raising funds for CCI. We had 65 people take part who raised over ¤65,000!

It was a fantastic day out that seen patients, IBD teams and other supporting partners join together and have some fun the process.

Launch of “Me and IBD” Colouring Journals children and teens In November 2023, we will be launching our new “Me and IBD” Colouring Journals for 7 – 14 year olds. When diagnosed with a chronic illness such as Crohn's disease or Ulcerative Colitis, it can be an overwhelming time to take in all the relevant information especially as a young person.

Our journals aim to help empower young people to become complete experts in their illness, understand all aspects of how it may impact their life, understand the terminology, learn about how their digestive system works, and help to remove fear and embarrassment around IBD. We have partnered with Crumlin Hospital on this initiative and will be providing some copies complimentary to their patients along with providing the journals in our under 18’s membership packs.

Looking to 2024 As we look to 2024, we are celebrating out 40th Anniversary and currently putting plans together to mark the occasion.

Some projects and initiatives we hope to launch include a clinical referral pathway to support newly diagnosis patients, and IBD Cook book, launch local networks, host webinars in a range of topics and more.

®

RINVOQ

▼

FOR ADULTS WITH MODERATE TO SEVERELY ACTIVE ULCERATIVE COLITIS1

RINVOQ® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1

Full Summary of Product Characteristics is available at www.medicines.ie ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; website: www.hpra.ie. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

AbbVie® is a registered trademark of AbbVie Inc. RINVOQ® and its design are registered trademarks of AbbVie Inc. REFERENCES: 1. RINVOQ® summary of product characteristics, available at www.medicines.ie.

Further information is available from AbbVie Limited, 14 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. Legal Classification: POM(S1A).

IE-RNQG-230034 | August 2023

End of Year Review: Thrombosis Ireland Our Achievements, Challenges & Opportunities Written by Ann Marie O’Neill, CEO, Thrombosis Ireland

Blood Clots (Venous Thromboembolism or VTE), is a leading cause of death and disability worldwide, with 544,000 VTE-related deaths every year in Europe alone. Up to 60% of VTE cases occur during or up to 90 days after hospitalisation, making it a leading preventable cause of hospital death. It is also the leading cause of maternal death in our Maternity Hospital. VTE is a life-changing and traumatic event. Among survivors of VTE, a significant burden of chronic morbidity (including painful postthrombotic syndrome) has been reported and it is associated with a major impact on quality of life.

The devastation that it can cause to survivors and the families who have lost loved ones, should not be understated, therefore, there is an urgent need to invest in national awareness and education of patients & healthcare professionals.

Blood clots can happen to anyone at any time. They usually occur when a person is experiencing more than one risk factor at any one time in their life. They are very preventable and easily treatable if caught on time but potentially fatal if the signs are missed. This is why it is so important that every person knows risk factors, signs to watch for and the importance of getting medical attention fast.

For more information: www.thrombosis.ie WHAT IS A BLOOD CLOT?

Thrombosis Ireland was officially formed by Patients in 2016 to address the lack of awareness and education for patients and Health Care Professionals about VTE and the complicated anticoagulation medication involved in treatment. We also have grave concerns about the absence of any co-ordinated physical or psychological recovery supports for blood clot patients and we will continue to advocate for improvements.

7 years on we are a fully voluntary, transparent, not-for-profit company limited by guarantee with charitable status and a strong determined and dedicated Board of Directors.

Our Mission

Our Biggest Challenge Our biggest challenge is to reach every household in Ireland with our life saving message. This requires a comprehensive & expensive national campaign on all platforms from TV to Radio and through social media. This is our Everest and highlights our 2nd biggest challenge – funding for these kind of campaigns and our day to support, awareness & education service. We must ensure that the these essential services will be available to everyone affected by blood clots into the future.

We are a fully voluntary charity and do not receive any direct core funding support from our Government or Health Department.

We could not do the work we do without the kind support of our grant sponsors. These grants are for use on specific awareness/ education projects and we are limited on what we can use the money for. Our challenge then is to raise enough core funding to pay for our rent, phone lines, printing, postage, insurance and auditors fees. We are dependent on fundraising events and sponsorship & donations from our members and the public for which we are truly grateful but this involves walking a tight rope as we never know how much we will manage to raise or receive.

We are small organisation and constantly worrying about raising income is very time consuming when we have many other lifesaving & patient support projects to be working on. If you know a company, who would like to support us to raise awareness about bloods and help patients

• To promote awareness of thrombosis among patients, medical staff and the general public nationwide.

• To provide support, education and advocacy for blood clot patients & their families.

Thrombosis Ireland World Thrombosis Day

• To save lives in particular from hospital acquired VTE through awareness and the introduction and implementation of a mandatory VTE assessment on admission to hospital and encourage distribution of the Blood Clot Alert Card to all patients attending our Hospitals as in or out patients.

VTE Awareness Event Kit & Multimedia National Awareness Campaign is kindly supported by

We believe that we will achieve our mission by creating national awareness of the risks & signs of blood clots, advocating for all patients to receive a VTE risk assessment and the Blood Clot Alert Card. We will also work closely with our VTE HSE National Lead, Prof. Fionnuala Ni

BlOOd clots know THE rISks AND signs

BLOOD CLOT ALERT CARD

RISKS

signs

SIGNS AND SYMPTOMS OF A BLOOD CLOT

This is the formation of a clot inside a blood vessel, usually in the leg, which may break off and go to the lungs. This can be fatal.

Warmth or redness in the leg or arm

60%90 DAYS

Chest pain (particularly when breathing deeply)

of clots happen in HOSPITAL

or in the

Ainle and the National HSE VTE Program (NVTEP), all health care professionals, our patients and the general public. We truly believe that we all have a part to play and TOGETHER WE ARE STRONGER!

following admission.

Swelling or pain in one leg or arm ➢Short of breath or rapid breathing

Cancer

Pregnancy

Immobility/ Leg Cast/ Long Haul Travel

Combined pill & oral HRT

Hospital Stay/ Surgery

Swelling or pain in one leg or arm

Warmth or redness Short of breath in one leg or arm or rapid breathing

Coughing or coughing up blood

Blood clots can be very serious - but there are effective treatments to deal with them and help prevent them CSN: 20154240

If you have one or more of these, you may have a clot and need urgent treatment

www.thrombosis.ie

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

Covid-19

Chest pain (particularly when breathing deeply)

Coughing or coughing up blood

CSN.20154240

Empowering people worldwide to live healthier at every stage of life

With 1,600 people working across five sites in Ireland, Viatris provides access to medicines, develops innovative solutions and improves healthcare for patients.

Viatris Newenham Court, Malahide Road, Dublin 17, Dublin, Ireland.

Viatris.ie Job Code: CC-2023-001 Date of Preparation: July 2023 www.viatris.ie

End of Year Review: Thrombosis Ireland continued and their families, or you are an individual and you would like to host a fundraiser for us, please don’t hesitate to reach out to us.

We would love to talk to you and share our mission.

Our Achievements 2023 has been a really busy year for Thrombosis Ireland. Our impact has grown and we can see this by the number of patients reaching out to us and receiving our recovery support pack. We supplied 40 event kits in 2022 but this year we provided & delivered 72 complete kits, including tablecloth, balloons, posters, banner, pens, lanyards and patient information booklets for 72 Blood Clot Awareness Events in every General and Maternity Hospital throughout the country and also to our first responders in our National Ambulance Service, Lifeline Private Ambulance Service and Dublin Fire Brigade. We would like to thank all those who participated this year and all the work and effort involved.

The work of our Health care professionals does not go unnoticed. In 2023 we hosted our 3rd VTE Exemplar Award Competition & Award Ceremony, which takes place at the International Conference, VTE Dublin each year. These awards highlight achievements in healthcare settings in a number of areas of Blood Clot prevention, treatment, recovery & research and this year we introduced a new category, ‘Best Student VTE Research Project’ to encourage early researchers. Winners presentation available at https:// thrombosis.ie/wp-content/ uploads/2023/10/2023-WinnersPresentation-from-Google-1.pdf Winners of our 2023 Thrombosis Ireland VTE Exemplar Awards: Best VTE Quality Improvement in a General Hospital Eimear Roche, VTE Management QI Team, St. James Hospital, Dublin.

Best VTE Quality Improvement in a Maternity Hospital Joanna Desmond, ADM, Limerick University Maternity Hospital Best VTE Scientific Advancement Award Dr Barry Kevane & IEHG VTE Working Group Best Student VTE Project Gavin Buckley, Cork University Hospital VTE Warrior Awards 2023 These special individual awards, honour their commitment on a daily basis to ensure VTE Patients receive optimal safe care and education in a truly compassionate and holistic way.

Mary Savage, ANP, Our Lady of Lourdes Hospital, Drogheda, Co. Louth.

Noirin Bannon, Programme Manager, Ireland East Hospital Group.

Emily Bury ANP, Acute Medicine Unit, St. Vincents University Hospital, Dublin.

Virginia Silvari, Chief II, Pharmacist, Cork University Hospital, Cork.

Bibi Bassa, Emergency Medicine Registrar, Mater Hospital, Dublin.

Best Maternity Hospital Aana Dineen, Senior Clinical Pharmacist & Consultant Gynaecologist, Dr. Zibi Marchocki, Cork University Maternity Hospital.

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

TO LIVE WELL WITH HIV

DEVELOPED WITH THE HIV COMMUNITY, FOR THE HIV COMMUNITY For information and resources to support those living with HIV to live well visit www.hivfindyourfour.ie

Find Your Four is a campaign developed and funded by Gilead Sciences, in collaboration with the HIV community.

UK-UNB-3430 | January 2023

End of Year Review: Thrombosis Ireland continued Best Hospital 2023 Emer O’Sullivan Q&R & Patient Safety Manager & Carol Walsh ANP Acute Medicine at Bantry General Hospital, Bantry, Co. Cork Best Hospital Group 2023 CEO, Declan Lyons, Ireland East Hospital Group.

VTE National Champion Reserved for an individual or hospital who has gone above an beyond to improve VTE awareness, education, diagnosis, treatment and recovery services for their patients.

Dr. Karl Ewins, Consultant Haematologist, Beaumont University Hospital, Dublin.

Insert Photos of The VTE Exemplar Awards Presentation.

We are proud to showcase our new Patient Information Resources for 2023: Our greatest pride is with the Patients who ‘Stand Up and Shout Out’ for Awareness of blood clots by sharing their personal stories in writing or through video. We are so grateful for their courage or the courage of their families to stand with us to help save others.

Read or watch the Personal stories available on our website https:// thrombosis.ie/patient-videos/

Working with Ireland East Hospital Group, we trialled and finalised our ‘Blood Clot Alert Card QR Code Poster’ which provides QR codes for our HSE/Thrombosis Ireland Blood Clot Alert Card in 20 Languages and approved by our National VTE Program for National use. https://thrombosis. ie/wp-content/uploads/2023/10/ NVTEP-Thrombosis-Ireland-QRCode-Poster-FINAL-PDF.pdf

Menopause and Clots

Working with The Rotunda Hospital and The University of Medicine & Health Sciences (RCSI), we now have our first National ‘Blood Clots in Pregnancy & After Birth’ patient information booklet approved by our National VTE Program for use nationally. https://thrombosis.ie/wp-content/ uploads/2023/10/Blood-ClotsIn-Pregnancy-and-After-BirthBooklet-FINAL-VERSION.pdf Our thanks to Dr. Beverly Hunt, Thrombosis UK and Dr. Louise Newson, The Menopause Charity, we now have our first patient information booklet on ‘Menopause & Blood Clots’ approved by our National VTE Program for use nationally. https://thrombosis.ie/wp-content/ uploads/2023/06/Final-PDFNVTEP-Menopause-and-ClotsBooklet-v2023-06-10a.pdf

Can I take HRT if I have an increased risk of a blood clot?

SCAN ME

Unit 4, Terenure Enterprise Centre, 17 Rathfarnham Road, Dublin 6W, Ireland - D6W YW11 +353 87 363 4828 | info@thrombosisireland.ie | www.thrombosis.ie | Charitable Status Number: 20154240 Thrombosis Ireland

Am I at risk?

Blood Clot Information BLOOD CLOT ALERT CARD

For more information: www.thrombosis.ie

60%90 DAYS

WHAT CAN I DO TO HELP MYSELF? Ask for your risk of blood clots to be assessed, especially if you are in one of the higher risk groups listed opposite

Swelling or pain in one leg or arm Warmth or redness in the leg or arm

following admission.

RISK MAY INCREASE FURTHER IF: you or a close relative had a blood clot you had surgery in the last 90 days you have thrombophilia (tendency to clot) you are on the oral contraceptive pill or HRT you have heart, lung or inflammatory disease you are over 60 years of age or are overweight you have varicose veins that become red and sore

Remember, a blood clot in the veins is more likely up to 90 days after being in hospital

Blood clot information (English)

CSN: 20154240

than on an

AEROPLANE!

�Drink plenty of fluids

If you have one or more of these, you may have a clot and need urgent treatment

are admitted to hospital and for 90 days after you go home have active cancer or receiving cancer treatment are pregnant or have had a baby less than 6 weeks ago become immobile (more than 3 days in bed / travel non-stop more than 6 hours / in a leg cast)

clot in HOSPITAL

�If directed to use stockings or medication to prevent or treat a clot follow instructions exactly

Coughing or coughing up blood

Blood clots can be very serious - but there are effective treatments to deal with them and help prevent them

Am I at risk?

YOU MAY BE AT HIGHER RISK IF YOU:

You have a HIGHER CHANCE of getting a

�Walk and move as much as possible

�Short of breath or rapid breathing Chest pain (particularly when breathing deeply)

of clots happen in HOSPITAL

or in the

BLOOD CLOT ALERT CARD

SIGNS AND SYMPTOMS OF A BLOOD CLOT

This is the formation of a clot inside a blood vessel, usually in the leg, which may break off and go to the lungs. This can be fatal.

@thrombosisireland

Breaking News to be proud of was the announcement by International Organisation

BLOOD CLOTS

WHAT IS A BLOOD CLOT?

@thrombosisirl

If you have any signs or symptoms of a clot, take immediate action to seek medical help

World Thrombosis Day was the award of International World Thrombosis Day Patient Ambassador of the Year 2023 for my work to raise awareness about VTE In Ireland and Internationally and to advocate for Blood Clot Patients and their families. I am so proud to receive this award on behalf of my amazing Volunteer Team in Thrombosis Ireland.

Opportunities and Developments for 2024

‫معلومات خاصة بالجلطة الدموية‬

血液凝块信息

(Arabic)

(Chinese)

ιατρικές πληροφορίες για θρόμβους (Greek)

Informacije o krvnom ugrušku (Croatian)

Eolas faoi théachtáin fola (Irish)

Informações sobre Informații despre coágulos sanguíneos cheagurile de sânge (Portuguese) (Romanian)

Oplysninger om blodprop (Danish)

Informazioni sulla coagulazione del sangue (Italian)

Информация о тромбах (Russian)

Informatie over bloedproppen (Dutch)

血栓について (Japanese)

Información sobre los coágulos sanguíneos (Spanish)

Information on blodpropp (Swedish)

Informations sur les caillots sanguins (French)

Informacija apie kraujo krešulius (Lithuanian)

Інформація про тромби (Ukrainian)

Information zu Blutgerinnsel (German)

Informacje na temat zakrzepów krwi (Polish)

‫خون کے جمنے کی معلومات‬

(Urdu)

Ask to be assessed for your risk of a blood clot.

PP281C Unit 4, Terenure Enterprise Centre, 17 Rathfarnham Road, Dublin 6W, Ireland - D6W YW11 +353 87 363 4828 | info@thrombosisireland.ie | www.thrombosis.ie | Charitable Status Number: 20154240 Thrombosis Ireland

@thrombosisirl

@thrombosisireland

Thrombosis Ireland

Thrombosis Ireland

As a member of our National VTE Program, Clinical Working Group we will continue to be the voice of the Patient to advocate for mandatory VTE Risk Assessment of every patient, clear National Guidelines on Prevention, Treatment & Recovery Pathway’s to be implemented in every hospital in the country so that no matter what hospital you attend, you get the same high standard of VTE care.

We will work closely with our HSE National VTE Program to develop more standardised National Patient Information booklets for use throughout every hospital in the country.

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

Thrombosis Ireland

Thrombosis Ireland

We will also continue our work to develop a Blood Clot Recovery Program to include Patient Education, Physical Recovery and Psychological Recovery.

The Thrombosis Ireland Education & Support Road Show ‘Thrive with Thrombosis’ will visit a number of counties throughout 2024 and if you would like to work with us to host a Patient & Staff VTE Education Event in your Hospital, don’t hesitate to reach out to us.

Patient Education is crucial for optimal recovery and we are determined to ensure all blood clot patients receive education and support to aid their recovery.

Listen out for our Blood Clot Awareness National Radio Advert on RTE1, Newstalk and Today Fm in January and February 2024 to kick of the year with a bang. Our mission is to ensure that every household in the country will know the what increases their risk of getting a blood clot, the signs and symptoms to watch out for, things you can do to prevent a blood clot and what to do if you suspect a clot. We will not stop until this is a reality. For more information go to our website www.thrombosis.ie

Choose Cosentyx today, to protect your psoriasis patients tomorrow1-4

1 million patients treated5

No new safety signals identified in clinical trials or the real world6,7

YRS

on the market in Ireland8 ABBREVIATED PRESCRIBING INFORMATION Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

COSENTYX (secukinumab) Presentations: Cosentyx 150 mg solution for injection in pre-filled pen and Cosentyx 300 mg solution for injection in pre-filled pen. Therapeutic Indications: The treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy; the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy; the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy; the treatment, alone or in combination with methotrexate (MTX), of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate; the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy; the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non-steroidal antiinflammatory drugs (NSAIDs); alone or in combination with methotrexate (MTX), the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy; alone or in combination with methotrexate (MTX), the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Dosage & Method of Administration: Adult Plaque Psoriasis: 300 mg given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. Dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Based on clinical response, a maintenance dose of 300 mg every 2 weeks may provide additional benefit for patients with a body weight of 90 kg or higher.

Paediatric Plaque Psoriasis: The recommended dose is based on body weight (see Table 1 in SmPC for full details) and administered by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 75 mg dose is given as 1 subcutaneous injection of 75 mg. Each 150 mg dose is given as 1 subcutaneous injection of 150 mg. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as 2 subcutaneous injections of 150 mg. The 150 mg and 300mg solution for injection in pre-filled syringe and pre-filled pens are not indicated for administration to paediatric patients with a weight <50 kg.

Hidradenitis suppurativa (HS): The recommended dose is 300 mg of secukinumab by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3, and 4, followed by monthly maintenance dosing. Based on clinical response, the maintenance dose can be increased to 300 mg every 2 weeks. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. Psoriatic Arthritis: For patients with concomitant moderate to severe plaque psoriasis, please refer to adult plaque psoriasis recommendation.

For patients who are anti-TNFα inadequate responders, the recommended dose is 300 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. For all other patients, the recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Based on clinical response, the dose can be increased to 300 mg. Ankylosing Spondylitis (AS, radiographic axial spondyloarthritis): The recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 3 and 4, followed by monthly maintenance dosing.

Based on clinical response, the dose can be increased to 300 mg. Non-radiographic axial spondyloarthritis (nraxSpA): The recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Juvenile idiopathic arthritis (JIA): Enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA): The recommended dose is based on body weight (see Table 2 in SmPC for full details) and administered by subcutaneous injection at weeks 0, 1, 2, 3, and 4, followed by monthly maintenance dosing. Each 75 mg dose is given as one subcutaneous injection of 75 mg. Each 150 mg dose is given as one subcutaneous injection of 150 mg. The 150 mg and 300 mg solution for injection in pre-filled syringe and in pre-filled pen are not indicated for administration to paediatric patients with a weight <50 kg.

Cosentyx may be available in other strengths and/or presentations depending on the individual treatment needs. For all of the above indications, available data suggest that a clinical response is usually achieved within 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients who have shown no response up to 16 weeks of treatment. Some patients with initially partial response may subsequently improve with continued treatment beyond 16 weeks. The safety and efficacy of Cosentyx in children with plaque psoriasis and in the juvenile idiopathic arthritis (JIA) categories of ERA and JPsA below the age of 6 years have

not been established.The safety and efficacy in children below the age of 18 years in other indications have not yet been established. Contraindications: Severe hypersensitivity reactions to the active substance or to any of the excipients. Clinically important, active infection (e.g. active tuberculosis). Warnings/Precautions: Infections: Secukinumab has the potential to increase the risk of infections. Serious infections have been observed in patients receiving secukinumab in the post-marketing setting. Infections observed in clinical studies are mainly mild or moderate upper respiratory tract infections such as nasopharyngitis not requiring treatment discontinuation. Non-serious mucocutaneous candida infections more frequently reported for secukinumab than placebo in psoriasis clinical studies. Caution in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, close monitoring and discontinue treatment until the infection resolves.

Should not be given to patients with active tuberculosis. Anti-tuberculosis therapy should be considered prior to initiation in patients with latent tuberculosis. Inflammatory bowel disease: Cases of new or exacerbations of inflammatory bowel disease have been reported with secukinumab. Secukinumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, secukinumab should be discontinued and appropriate medical management should be initiated. Hypersensitivity reactions: In clinical studies, rare cases of anaphylactic reactions have been observed in patients receiving secukinumab. If an anaphylactic or other serious allergic reactions occur, administration should be discontinued immediately and appropriate therapy initiated. Latex-sensitive individuals: The removable cap of the Cosentyx pre-filled pen contains a derivative of natural rubber latex. Vaccinations: Live vaccines should not be given concurrently with secukinumab. Patients may receive concurrent inactivated or non live vaccinations. Prior to initiating therapy with Cosentyx, it is recommended that paediatric patients receive all age appropriate immunisations as per current immunisation guidelines. Concomitant immunosuppressive therapy: Use in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. Interactions: Live vaccines should not be given concurrently with secukinumab. In a study in adult subjects with plaque psoriasis, no interaction was observed between secukinumab and midazolam (CYP 3A4 substrate. No interaction seen when administered concomitantly with methotrexate (MTX) and/or corticosteroids. Caution should be exercised when considering concomitant use of other immunosuppressants and secukinumab. Fertility, Pregnancy and Lactation: Women of childbearing potential should use an effective method of contraception during treatment and for at least 20 weeks after treatment. It is preferable to avoid the use of Cosentyx in pregnancy as there are no adequate data from the use of secukinumab in pregnant women. It is not known whether secukinumab is excreted in human milk. A decision on whether to discontinue breast feeding during treatment and up to 20 weeks after treatment or to discontinue therapy with Cosentyx must be made taking into account the benefit of breast-feeding to the child and the benefit of Cosentyx therapy to the woman. The effect of secukinumab on human fertility has not been evaluated. Undesirable Effects: Very common (≥1/10); Upper respiratory tract infections. Common (≥1/100 to <1/10); Oral herpes, rhinorrhoea, diarrhoea, fatigue, nausea and headache Uncommon (≥1/1,000 to <1/100); Oral candidiasis, otitis externa, urticaria, neutropenia, dyshidrotic eczema, conjunctivitis, lower respiratory tract infections, tinea pedis and inflammatory bowel disease. Rare (≥1/10,000 to <1/1,000); Anaphylactic reactions, exfoliative dermatitis and hypersensitivity vasculitis. Unknown: Mucosal and cutaneous candidiasis (including oesophageal candidiasis) and pyoderma gangrenosum. Please see Summary of Product Characteristics for further information on undesirable effects. Legal Category: POM. Marketing Authorisation Holder: Novartis Europharm Ltd, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland. Marketing Authorisation Numbers: EU/1/14/980/004 and EU/1/14/980/010. Prescribing Information last revised: May 2023. Full prescribing information is available upon request from: Novartis Ireland Limited, Vista Building, Elm Park Business Park, Elm Park, Dublin 4. 01-2601255 or at www.medicines.ie. Detailed information on this product is also available on the website of the European Medicines Agency http://www.ema.europa.eu.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance at www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing drugsafety.dublin@novartis. com or by calling (01) 2080 612.

References: 1. Sigurgeirsson B et al. Dermatol Ther. 2022;35(3):e15285. 2. Bissonnette R et al. J Eur Acad Dermatol Venereol. 2018;32(9):1507-1514. 3. McInnes IB et al. Lancet Rheumatol. 2020;2(4):e227-e235.

4. McInnes IB et al. Rheumatology (Oxford). 2017;56(11):1993-2003. 5. Novartis Data on File. Cosentyx Patient Reach Feb 2023. 6. Novartis Data on File RWE Compendium Sept2021-Mar2022. 7. Gottlieb AB, et al. Acta Derm Venereol. 2022. doi: 10.2340/actadv.v102.563. 8. NCPE Secukinumab (Cosentyx®) Assessment | National Centre for Pharmacoeconomics Accessed Mar 2023.

July 2023 I IE296850

32 Overactive Bladder

Overactive Bladder: Diagnosis and Treatment An interview with Theresa Lowry-Lehnen, RGN, RNP, PhD, Clinical Nurse Specialist and Associate Lecturer with South East Technological University

“OAB can impact significantly on quality of life and is responsible for several other comorbidities, including falls and fractures, depression, and increased risk of admission to hospitals and nursing homes,” she adds.

Overactive bladder syndrome is a chronic disabling condition that significantly reduces the quality of life of millions of people worldwide. We recently spoke to Theresa Lowry Lehnen PhD Clinical Nurse Specialist and Associate Lecturer South East Technological University to learn more about its management and impact in Ireland.

The ICS define overactive bladder as “urinary urgency, usually accompanied by frequency and nocturia, with or without UUI, in the absence of UTI or other obvious pathology”. The definition of overactive bladder (OAB) has undergone changes over time, and currently the most commonly accepted definition is that of the International Consultation on Incontinence Research Society (ICI-RS): ‘overactive bladder syndrome is characterised by urinary urgency, with or without urgency urinary incontinence, usually with increased daytime frequency and nocturia, if there is no proven infection or other obvious pathology’.

and nocturia, in the absence of urinary tract infection or other obvious pathology.

She adds, “The evaluation of OAB should include a detailed medical history, physical examination, and laboratory tests to exclude other causes of lower urinary tract symptoms, such as urinary tract infection, bladder stones, or malignancy.

“Dipstick urinalysis should be carried out, and a sample may also be sent to the lab to rule out haematuria, infection, and glycosuria, which could indicate the presence of diabetes. Blood tests including levels of creatinine and glycosylated haemoglobin (HbA1C) can also provide additional information.

Diagnosis

“A detailed medical history can highlight possible risk factors for OAB. The history should focus on voiding and lower urinary tract symptoms, the severity of symptoms and their impact on the patient’s quality of life.

Symptom questionnaires can be used to highlight the impact of the condition on quality of life and to determine whether the patient requires treatment. There are numerous validated questionnaires available, however, they are not widely used.

The diagnosis of OAB is based on the presence of urinary urgency, with or without urge incontinence, usually associated with frequency

“Examination should include assessment of urinary, gynaecological, and neurological systems. A focused clinical

The symptoms of OAB include urgency, frequency, nocturia and urgency incontinence, and many patients experience combinations of these symptoms. Urgency incontinence is more common in women, and urgency and frequency more common in men.

Theresa says, “The diagnosis of OAB can be challenging due to the lack of a specific diagnostic test and the overlap of symptoms with other lower urinary tract disorders.”

Theresa told us, “Overactive bladder syndrome affects approximately 350,000 people over the age of 40 in Ireland.

Although the condition is more common in adults over the age of 40, it can also affect children and young people. The prevalence of OAB increases with age, affecting up to 17% of the population over the age of 18, and 30% of those over 65 years of age.

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

examination can highlight risk factors and pre-existing conditions and should include an abdominal examination, digital rectal examination of the prostate in males and a vaginal examination in females.”

Theresa notes that abdominal palpation and vaginal examination enables identification of a palpable bladder and prolapse or pelvic mass in females. Symptoms of OAB in men are often attributed to bladder outflow obstruction resulting in misdiagnosis and delays in treatment.

“A digital rectal exam is imperative to rule out the presence of prostatic hypertrophy, malignancy, and poor rectal tone. Neurological causes of OAB can include spinal cord injury, myelodysplasia, or multiple sclerosis. Out ruling neurological causes is important, as these patients may be at risk of upper tract deterioration/renal failure.

“A voiding diary is a useful tool for assessing the frequency and volume of voids, urgency, and episodes of urge incontinence.

Uroflowmetry can assess voided volume, flow rate, and post void residual urine volume.

Cystoscopy and urodynamics are usually not necessary for the diagnosis of OAB, but may be helpful in selected cases, such as when there is suspicion of bladder outlet obstruction or neurogenic bladder.”

Switch to Simponi and drive on

Effectiveness of golimumab in rheumatology patients after failure of initial TNFαi therapy - A pooled data analysis.1 Simponi, in combination with methotrexate (MTX), is indicated for:2

• the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.

• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX

Scan here to download ‘Switch to Simponi and drive on’ leaflet

patients with risk factors for skin cancer. Heart Failure: Golimumab should be used with caution in patients with mild heart failure (NYHA class I/II). Patients should be closely monitored and golimumab must be discontinued in patients who develop new or worsening symptoms of heart failure. Some cases had a fatal outcome. Neurological events: Use of anti-TNF therapy, including golimumab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders. Discontinuation of golimumab should be considered if these disorders develop. Carefully consider the benefits and risks before initiation of therapy in patients with a history of demyelinating disorders. Surgery: Patients requiring surgery whilst on golimumab therapy should be closely monitored for infections. Autoimmune processes: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with golimumab and is positive for antibodies against double-stranded DNA, treatment should be discontinued. Haematological reactions: There have been post-marketing reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anaemia, and thrombocytopaenia in patients receiving TNF-blockers, including golimumab. Patients should be advised to seek medical attention if they develop signs and symptoms suggestive of blood dyscrasias. Discontinuation should be considered in patients with significant haematologic abnormalities. Vaccinations/therapeutic infectious agents: It is recommended that live vaccines or any therapeutic infectious agents should not be given concurrently. Allergic reactions: If an anaphylactic reaction or other serious allergic reaction occurs, administration of golimumab should be discontinued immediately, and suitable treatment initiated. The needle cover of the pre-filled pen contains latex and may cause allergic reactions in those sensitive to latex. Special populations: Older patients (≥ 65 years): Adverse events, serious adverse events and serious infections in patients aged ≥65 were comparable to those observed in younger patients.

However, caution should be exercised when treating the elderly, particular attention should be paid to infections. There were no patients age 45 and over in the nr-Axial SpA study. Paediatric patients (<18 years): Vaccinations: it is recommended that prior to initiating golimumab therapy, paediatric patients be brought up to date with all immunisations in agreement with current immunisation guidelines. Excipients: Simponi contains sorbitol (E420). In patients with rare hereditary problems of fructose intolerance, the additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. INTERACTIONS Combination of golimumab and other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended. PREGNANCY AND LACTATION Administration of golimumab is not recommended during pregnancy or breast-feeding. Women of childbearing potential should use adequate contraception and continue its use for at least 6 months after the last golimumab treatment. SIDE EFFECTS Refer to SmPC for complete information on side effects Very Common (≥ 1/10): upper respiratory tract infection; Common (≥1/100): bacterial infections, lower respiratory tract infections, viral infections, bronchitis, sinusitis, superficial fungal infections, abscess, leukopenia (including neutropenia), anaemia, allergic reactions, autoantibody positive, depression, insomnia, dizziness, headache, paraesthesia, hypertension, asthma and related symptoms, dyspepsia, gastrointestinal and abdominal pain, nausea, gastrointestinal inflammatory disorders, stomatitis, alanine aminotransferase increased, aspartate aminotransferase increased, pruritus, rash, alopecia, dermatitis, pyrexia, asthenia, injection site reaction, chest discomfort, bone fractures were reported. Serious, including fatal adverse events have been reported including septic shock, lymphoma, leukaemia, melanoma, Merkel cell carcinoma, hepatosplenic T-cell lymphoma*, leukopenia, thrombocytopaenia, pancytopaenia, aplastic anaemia, agranulocytosis, serious systemic hypersensitivity reactions (including anaphylactic reaction), skin exfoliation, vasculitis (systemic), sarcoidosis, demyelinating disorders, congestive heart failure, arrhythmia, ischaemic coronary artery disease, thrombosis, interstitial lung disease and lupus-like syndrome. * Observed with other TNF-blocking agents. Paediatric population: pJIA: The safety of golimumab has been studied in a phase III study of 173 pJIA patients from 2 to 17 years of age. The average follow-up was approximately two years. In this study, the type and frequency of adverse events reported were generally similar to those seen in adult RA studies. PACKAGE QUANTITIES 1 x 50 mg pre-filled pen containing 50 mg of golimumab in 0.5 ml solution for injection 1 x 50 mg pre-filled syringe containing 50 mg of golimumab in 0.5 ml solution for injection 1 x 100 mg pre-filled pen containing 100 mg of golimumab in 1 ml solution for injection Legal Category: Prescription Only Medicine. Marketing Authorisation Number 50 mg Pre-filled Pen EU/1/09/546/001 50 mg Pre-filled Syringe EU/1/09/546/003 100 mg Pre-filled Pen EU/1/09/546/005 Marketing Authorisation Holder Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands Date of Revision of Text: February 2019 © Merck Sharp & Dohme Ireland (Human Health) Limited 2019. All rights reserved. Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin 18 or from www.medicines.ie. X-083G-Feb2019.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie Adverse events should also be reported to MSD (Tel: 01-299 8700) References 1. Govoni M, et al. Poster presented at the American College of Rheumatology; Philadelphia, PA, USA; November 10-14, 2022.

Abstract available at Arthritis Rheumatol. 2022; 74 (suppl 9).

2. Simponi Summary of Product Characteristics Feb 2023

Red Oak North, South County Business Park, Leopardstown, Dublin D18 X5K7 Ireland

IE-GOL-00230 Date of Preparation: July 2023

Simponi 50 mg, 100 mg Solution for Injection in pre-filled pen Simponi 50 mg Solution for Injection in pre-filled syringe (golimumab) ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing PRESENTATION Simponi 50 mg solution for injection in pre-filled pen Simponi 50 mg solution for injection in pre-filled syringe Simponi 100 mg solution for injection in pre-filled pen INDICATIONS Rheumatoid Arthritis (RA): Simponi, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate; the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function; Psoriatic Arthritis (PsA): Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive PsA in adults when the response to DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Ankylosing Spondylitis (AS): Simponi is indicated for the treatment of severe, active AS in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-Axial SpA): Simponi is indicated for the treatment of severe, active nr-Axial SpA who have had an inadequate response to or are intolerant to NSAIDs. Ulcerative colitis (UC): Simponi is indicated for treatment of moderately to severely active UC in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Polyarticular juvenile idiopathic arthritis (pJIA): Simponi 50mg in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with MTX. DOSAGE AND ADMINISTRATION Simponi should be injected subcutaneously. Treatment should be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of RA, PsA, AS, nr-Axial SpA, UC or pJIA. After proper training in subcutaneous injection technique, patients may self-inject, if their physician deems it appropriate. RA: Simponi 50 mg given once a month, on the same date each month, concomitantly with MTX. PsA: Simponi 50 mg given once a month, on the same date each month, alone or in combination with MTX. AS and nr-Axial SpA: Simponi 50 mg given once a month, on the same date each month. Clinical response is usually achieved within 12-14 weeks of treatment (3 or 4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period. In patients weighing more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse reactions with the 100 mg dose compared with the 50 mg dose. UC: Patients weighing < 80 kg: Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2. Patients who have an adequate response should receive 50 mg at week 6 and every 4 weeks thereafter. Patients who have an inadequate response may benefit from continuing with 100 mg at week 6 and every 4 weeks thereafter. Patients weighing ≥ 80 kg: Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks.

During maintenance treatment, corticosteroids may be tapered, following clinical practice guidelines. Clinical response is usually achieved within 12-14 weeks of treatment (after 4 doses). pJIA: Simponi 50 mg administered once a month, on the same date each month, for children with a body weight of at least 40 kg. Clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Missed dose: If a patient forgets to inject Simponi on the planned date, the forgotten dose should be injected as soon as the patient remembers. The patient should be instructed not to inject a double dose. Older patients (≥ 65 years): no dose adjustment required. Paediatric patients (<18 years): For indications other than pJIA, Simponi is not recommended. Patients with renal and hepatic impairment: Simponi is not recommended. CONTRAINDICATIONS Patients with a hypersensitivity to golimumab or any of the excipients; Patients with active tuberculosis (TB) or other severe infection such as sepsis and opportunistic infections; patients with moderate or severe heart failure (NYHA class III/IV). PRECAUTIONS AND WARNINGS Infections: Patients must be monitored closely for infection before, during and for 5 months after cessation of treatment. Exercise caution when considering golimumab in patients with chronic infection or a history of recurrent infection including use of concomitant immunosuppressive therapy. Golimumab should not be given to patients with clinically important active infection. Patients should be advised of the potential risk factors. Bacterial infections (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported. The invasive fungal infection should be suspected if they develop a serious systemic illness. There was a greater incidence of serious infections, including opportunistic infections and TB, in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg. Serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infection. There have been reports of active TB in patients receiving golimumab, including patients previously treated for latent TB. Patients should be evaluated for active or latent TB before golimumab treatment. All such tests should be recorded on the Patient Reminder Card provided with the product. If active TB is diagnosed, treatment with golimumab should not be initiated. If latent TB is diagnosed, treatment with anti-TB therapy must be initiated before initiation of golimumab. Patients on golimumab should be monitored closely for signs and symptoms of active TB and advised to seek medical advice if signs and/or symptoms of TB appear. Hepatitis B (HBV) reactivation: Reactivation of HBV occurred in patients receiving golimumab who were chronic carriers. Some cases had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with golimumab Malignancies and lymphoproliferative disorders: Caution is advised when considering golimumab treatment in patients with history of malignancy or continuing treatment in patients who develop a malignancy, additional caution should be exercised in patients with increased risk for malignancy due to heavy smoking. A risk for the development of malignancies in children and adolescents cannot be excluded. Rare cases, usually fatal, of hepatosplenic T-cell lymphoma (HSTCL) have been reported, the majority of cases occurred in adolescent and young males nearly all on concomitant treatment with azathioprine (AZA) or 6-mercaptopurine (6–MP). The potential risk with the combination of AZA or 6-MP and golimumab should be carefully considered. A risk for the development for HSTCL in patients treated with TNF-blockers cannot be excluded. Colon dysplasia/carcinoma - Screen for dysplasia in all patients with UC who are at increased risk or had a prior history for dysplasia or colon carcinoma. In newly diagnosed dysplasia patients the risks and benefits of continued golimumab use should be carefully assessed. Melanoma and Merkel cell carcinoma (all TNF-blocking agents including golimumab) have been reported, periodic skin examination is recommended, particularly for

34 Overactive Bladder Anticholinergic drugs and properties Treatment and Management of OAB Treatment and management of OAB is based on a stepwise approach, including lifestyle modifications, behavioural therapy, pharmacotherapy, and in selected cases invasive therapy, Theresa says.

“First line treatment is lifestyle modification, including bladder training exercises, pelvic floor exercises and fluid management strategies. Bladder training exercises involve gradually increasing the time between voiding to increase bladder capacity and reduce urgency.

“Pelvic floor exercises aim to strengthen the pelvic floor muscles, which can improve bladder control and reduce urinary incontinence. Fluid management strategies include reducing caffeine and alcohol intake, as these can irritate the bladder and exacerbate OAB symptoms.

Reduction in fluid intake by 25% may help improve symptoms of OAB but not UI. Advice on fluid intake should be based on 24hour fluid intake and urine output measurements. Patients should be advised that fluid intake should be sufficient to avoid thirst and that an abnormally low or high 24-hour urine output should be investigated. If overweight, weight loss is encouraged as weight loss has a significant positive effect on leakage. Patients should also be advised to stop smoking if applicable and increase dietary fibre to avoid constipation.”

Theresa says that pharmacological therapy is often required when lifestyle modifications are ineffective or insufficient.

“Antimuscarinic drugs are the first line pharmacological treatment for OAB. These drugs work by blocking the muscarinic receptors in the bladder, reducing detrusor muscle contractions, and increasing bladder capacity. There are several antimuscarinic drugs available including oxybutynin, tolterodine, trospium, solifenacin, darifenacin, and fesoterodine.

“The choice of drug depends on the patient’s individual characteristics, including age, co morbidities, and medication interactions. Absolute contraindications to anticholinergic use include urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and known hypersensitivity to the individual

https://irishpharmacist.ie/2022/10/05/treatment-and-management-of-oab/

drugs or their ingredients. Elderly patients should be monitored for drug interactions or polypharmacy of drugs with anticholinergic effect i.e., antidepressants, antipsychotics, anxiolytics, as the overall anticholinergic load is associated with confusion, falls, and fractures Mirabegron is a β3-adrenoceptor agonist with a mechanism of action that is distinct from anticholinergics.

“It has a lower risk of adverse effects compared to antimuscarinic drugs, although it is associated with hypertension and tachycardia in some patients and is considered as a secondline therapy when patients are intolerant to anticholinergics.

“Desmopressin treatment may improve nocturia and urgency episodes. Desmopressin improves quality of sleep by prolonging the period of sleep until the first void and is shown to have an acceptable safety profile in certain patients with overactive bladder syndrome. “ If medications are not effective, intravesical botox injections are another option. Intravesical botulinum toxin A prevents acetylcholine release at the neuromuscular junction, resulting in temporary chemo denervation and muscle relaxation for up to 6 months.

Theresa explains, “The technique places multiple injections under cystoscopic guidance directly into the detrusor. Complete

continence can be achieved in 40% - 80% of patients, and bladder capacity improved by 56% for up to 6 months.

“Maximal benefit is achieved between two and six weeks, maintained over six months. The injections can be repeated when required according to the degree of improvement or relief of symptoms.

“Surgical intervention may be required in severe cases of OAB that are unresponsive to pharmacological therapy. Sacral nerve stimulation (SNS) is a surgical technique that involves implanting a device that delivers electrical impulses to the sacral nerves which regulate bladder function. SNS is associated with risks, including infection, device malformation, and nerve damage, and patients should be fully informed of the benefits and risks before undergoing the procedure.

Current indications for sacral nerve stimulation include refractory urge incontinence, refractory urgency and frequency, and idiopathic urinary retention.”

More radical treatments include augmentation cystoplasty and urinary diversion. Augmentation cystoplasty is an operation to enlarge the bladder and allow it to hold more urine, by attaching a piece of the body’s own tissue (usually from the bowel) to the bladder. Urinary diversion involves rerouting the ureters. This allows the bladder to be bypassed and the ureters to be routed directly to

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

the outside of the body allowing urine to be collected in an ostomy bag worn on the abdomen. Urinary diversion should be considered only when conservative treatments have failed, and if sacral nerve stimulation and augmentation cystoplasty are not appropriate or unacceptable to the patient.

Emerging Therapies Theresa notes that PDE1 and PDE5 inhibitors have demonstrated improvement in urodynamic parameters, however, PDE 5 inhibitors are not currently approved for OAB. “Percutaneous radiofrequency neurotomy has demonstrated feasibility in patients with neurogenic detrusor overactivity secondary to spinal cord injury, with significant improvement in patient symptoms scores. However, there is currently no evidence that transurethral radiofrequency improves patientreported symptoms of incontinence.

“Support for people with OAB Useful information and support for people in Ireland living with OAB is available at www.oab.ie.

The Continence Foundation of Ireland (CFI) improves the quality of life for people with incontinence and pelvic floor dysfunction, by raising awareness, and providing information and education.”

More information is available at: http://www.continence.ie/

50mgs once daily

BETMIGA 25 mg prolonged-release tablets & BETMIGA 50 mg prolonged-release tablets.

Her 10th shopping trip since the day she started BETMIGA1

Prescribing Information: BETMIGA™ (mirabegron) For full prescribing information, refer to the Summary of Product Characteristics (SPC). Name: BETMIGA 25 mg prolonged-release tablets & BETMIGA 50 mg prolonged-release tablets. Presentation: Prolongedrelease tablets containing 25 mg or 50 mg mirabegron. Indication: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Posology and administration: The recommended dose is 50 mg orally once daily in adults (including elderly patients). Mirabegron should not be used in paediatrics for OAB. A reduced dose of 25 mg once daily is recommended for special populations (please see the full SPC for information on special populations). The tablet should be taken with liquids, swallowed whole and is not to be chewed, divided, or crushed. The tablet may be taken with or without food. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SPC. Severe uncontrolled hypertension defined as systolic blood pressure ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg. Warnings and Precautions: Renal impairment: BETMIGA has not been studied in patients with end stage renal disease (eGFR < 15 ml/min/1.73 m2 or patients requiring haemodialysis) and, therefore, it is not recommended for use in this patient population. Data are limited in patients with severe renal impairment (eGFR 15 to 29 ml/min/1.73 m2); based on a pharmacokinetic study (see section 5.2 of the SPC) a dose of 25 mg once daily is recommended in this population. This medicinal product is not recommended for use in patients with severe renal impairment (eGFR 15 to 29 ml/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors (see section 4.5 of the SPC).

Hepatic impairment: BETMIGA has not been studied in patients with severe hepatic impairment (ChildPugh Class C) and, therefore, it is not recommended for use in this patient population. This medicinal product is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B) concomitantly receiving strong CYP3A inhibitors (see section 4.5 of the SPC). Hypertension: Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with mirabegron, especially in hypertensive patients. Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg). Patients with congenital or acquired QT prolongation: BETMIGA, at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies (see section 5.1 of the SPC). However, since patients with a known history of QT prolongation or patients who are taking medicinal products known to prolong the QT interval were not included in these studies, the effects of mirabegron in these patients is unknown.

Caution should be exercised when administering mirabegron in these patients. Patients with bladder outlet obstruction and patients taking antimuscarinics medicinal products for OAB: Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medicinal products for the treatment of OAB has been reported in postmarketing experience in patients taking mirabegron. A Date of preparation: January 2023

controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with BETMIGA; however, BETMIGA should be administered with caution to patients with clinically significant BOO. BETMIGA should also be administered with caution to patients taking antimuscarinic medicinal products for the treatment of OAB. Interactions: Caution is advised if mirabegron is co-administered with medicinal products with a narrow therapeutic index and significantly metabolised

by CYP2D6. Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated. In patients with mild to moderate renal impairment or mild hepatic impairment, concomitantly receiving strong CYP3A inhibitors, the recommended dose is 25 mg once daily. For patients who are initiating a combination of mirabegron and digoxin (P-gp substrate), the lowest dose for digoxin should be prescribed initially (see the SPC for full prescribing information). The potential for inhibition of P-gp by mirabegron should be considered when BETMIGA is combined with sensitive P-gp substrates.

Increases in mirabegron exposure due to drug-drug interactions may be associated with increases in pulse rate. Pregnancy and lactation: BETMIGA is not recommended in women of childbearing potential not using contraception. This medicinal product is not recommended during pregnancy. BETMIGA should not be administered during breast-feeding. Undesirable effects: Summary of the safety profile: The safety of BETMIGA was evaluated in 8433 adult patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received BETMIGA for at least 1 year (365 days). In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity. The most common adverse reactions reported for adult patients treated with BETMIGA 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections. The frequency of tachycardia was 1.2% in patients receiving BETMIGA 50 mg. Tachycardia led to discontinuation in 0.1% patients receiving BETMIGA 50 mg. The frequency of urinary tract infections was 2.9% in patients receiving BETMIGA 50 mg.

Urinary tract infections led to discontinuation in none of the patients receiving BETMIGA 50 mg. Serious adverse reactions included atrial fibrillation (0.2%). Adverse reactions observed during the 1-year (long term) active controlled (muscarinic antagonist) study were similar in type and severity to those observed in the three 12-week phase 3 double blind, placebo controlled studies. Adverse reactions: The following list reflects the adverse reactions observed with mirabegron in adults with OAB in the three 12-week phase 3 double blind, placebo controlled studies. The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be established from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse events are grouped by MedDRA system organ class. Infections and infestations:

Common: Urinary tract infection, Uncommon: Vaginal infection, Cystitis. Psychiatric disorders: Not known (cannot be estimated from the available data): Insomnia*, Confusional state*. Nervous system disorders: Common: Headache*, Dizziness*. Eye disorders: Rare: Eyelid oedema. Cardiac disorders: Common: Tachycardia, Uncommon: Palpitation, Atrial fibrillation. Vascular disorders: Very rare: Hypertensive crisis*.

Gastrointestinal disorders: Common: Nausea*, Constipation*, Diarrhoea*, Uncommon: Dyspepsia, Gastritis, Rare: Lip oedema. Skin and subcutaneous tissue disorders: Uncommon: Urticaria, Rash, Rash macular, Rash papular, Pruritus, Rare: Leukocytoclastic vasculitis, Purpura, Angioedema*. Musculoskeletal and connective tissue disorders: Uncommon: Joint swelling. Renal and urinary disorders: Rare: Urinary retention*. Reproductive system and breast disorders: Uncommon: Vulvovaginal pruritus. Investigations: Uncommon: Blood pressure increased, GGT increased, AST increased, ALT increased. * signifies adverse reactions observed during post-marketing experience. Prescribers should consult the SPC in relation to other adverse reactions. Overdose: Treatment for overdose should be symptomatic and supportive. In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended. Basic NHS Cost: Great Britain (GB)/Northern Ireland(NI): BETMIGA 50 mg x 30 = £29, BETMIGA 25 mg x 30 tablets = £29.

Ireland (IE): POA. Legal classification: POM. Marketing Authorisation number(s): (GB): PLGB 00166/0415-0416. NI/IE: EU/1/12/809/001-006, EU/1/12/809/008-013, EU/1/12/809/015018. Marketing Authorisation Holder: GB: Astellas Pharma Ltd., 300 Dashwood Lang Road, Bourne Business Park, Addlestone, United Kingdom, KT15 2NX. NI/IE: Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, The Netherlands. Date of Preparation of Prescribing information: January 2023. Job bag number: MAT-IE-BET-2023-00001. Further information available from: GB/NI: Astellas Pharma Ltd, Medical Information: 0800 783 5018. IE: Astellas Pharma Co. Ltd., Tel.: +353 1 467 1555.

For full prescribing information, please see the Summary of Product Characteristics, which may be found at: GB: www.medicines.org.uk; NI: https://www.emcmedicines.com/en-GB/northernireland/; IE: www.medicines.ie.

United Kingdom (GB/NI) Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Astellas Pharma Ltd. on 0800 783 5018.

Ireland Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance, Website: www.hpra.ie or Astellas Pharma Co. Ltd. Tel: +353 1 467 1555, E-mail: irishdrugsafety@astellas.com.

References: 1. Freeman R, et al. Current Medical Research and Opinion 2017. https://doi.org/10.1080/03007995.2017.1419170.

MAT-IE-BET-2023-00002

36 Advertorial

British Oncology Pharmacy Association Symposium 2023 This is created by Fresenius Kabi Ireland and intended for healthcare professionals only.

The 26th British Oncology Pharmacy Association (BOPA) symposium, held from the 6th to 8th October 2023, saw pharmacists from the United Kingdom and Ireland travel to Newport, South Wales.

Olivia Flynn - Chief II Pharmacist, Cancer Services, University Hospital Limerick “The BOPA 2023 Symposium was an excellent event which showcased development and innovation in the pharmaceutical industry and in clinical practice within cancer care in the UK. It was very inspiring to hear from healthcare and industry professionals about projects which have improved cancer services by increasing aseptic unit capacity, reducing waiting times and treatment-related side effects, and improving healthcare experiences for patients in minority groups. Congratulations to the BOPA committee for successfully delivering this event and a huge thank you to Fresenius Kabi for providing the opportunity to attend it alongside pharmacists working in other Irish cancer services.”

The BOPA symposium supplied some great insights on targeted therapies and advances in patient care. Leading experts showed case studies of their patients being managed with the most advanced cancers, through innovation in pharmaceutical treatments and developments in technology.

Immunotherapy, targeted therapy, and CAR-T cell therapy are some of the latest innovations in cancer treatment which were discussed in the breakout sessions.

The ICC in Wales was a great setting for this annual symposium.

The auditorium and meeting rooms are ultramodern, which allowed all delegates to comfortably access all the sessions. The pharmaceutical exhibition was a focal point for pharmacists and members of the pharmaceutical industry to interact and discuss the latest innovations in cancer treatments with exhibitors throughout the weekend.

“I was delighted to attend a fantastic event with informative symposium talks and breakout sessions, which was very well organised by the BOPA committee, thank you. It was discussed how cancer care is facing substantial challenges as health care professionals experience pressure to treat more patients and ensure their needs are met while also ensuring better outcomes. Collaboration aims to drive improved patient outcomes as health care professionals share experiences to improve efficiency & survival rates, reduce side effects and deal with new norms around sexuality, gender, and multiculturalism.”

Rachel Wright – Product Manager, Fresenius Kabi Ireland

“The tone of the sessions was that of positivity as clinicians discussed the many new treatment options available to them in 2023. Many of these treatments have been developed in the last decade, which demonstrates how far we have come. Treatments such as Immunotherapy, CAR-T (Chimeric Antigen Receptor T) and TIL (Tumour-Infiltrating Lymphocytes) therapy are revolutionary in the area of cancer treatment. Many of the discussions at BOPA highlighted the benefits of these treatments and the challenges for some patients of health economics, equitable access, and long lead times.”

Conor Sadlier – Sales Manager, Fresenius Kabi Ireland “It's important for us to be aware of the future treatment developments for cancer care, helping us to plan for the future. The networking opportunities facilitate us to help each other solve problems by looking at solutions that other centres in Ireland have found.”

Eoin Tabb - Chief II Pharmacist, Clinical Cancer Services, University Hospital Waterford.

Hannah O' Connor - Senior Pharmacist, Haematology, Oncology & Aseptics, St Vincent’s University Hospital

“Having recently moved into the cancer speciality the BOPA conference was a great opportunity for me to gain knowledge of current and upcoming cancer treatments in areas such as breast, melanoma, and immunotherapy. I feel I've come away with a much better understanding of treatments and a good foundation of learning to develop further back in practice.

I found it very inspirational to hear about novel pharmacist roles such as in supportive care, and innovative practices to streamline capacity and develop the future cancer workforce. I also really enjoyed meeting other cancer pharmacists to learn and share practice and ideas from other hospitals and forge connections with other teams.”

Megan Hockly - Senior Oncology Pharmacist, University Hospital Galway “Learning from the NHS specialist Pharmacists and future potential roles for pharmacists is inspiring and shows how our role could be further expanded in Ireland.

Provides a great networking opportunity among colleagues and shows how we are all facing the same issues with capacity and evolving treatments.”

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

The clinical programme provided comprehensive updates on current and future best practice cancer treatments alongside fascinating insights into future developments in ATMPs [Advanced Therapy Medicinal Products] and immunotherapy. Elaine Vicker's talk "Innovations in antibodybased cancer treatments" was a particular highlight. BOPA 2023 delivered some thought-provoking discussions on health equality and the delivery of patient centred cancer care in diverse populations amidst a capacity crisis. The launch of the SACT [Systemic Anti-Cancer Therapy] digital passport on Sunday morning demonstrated how a national, standardised, transferable training tool can be developed - this could be very useful in an Irish context.

It was a pleasure to meet the other delegates and exchange ideas

37

our UK colleagues face many of the same challenges as ourselves in terms of capacity and service provision. There were also some very interesting lectures given by our oncology nursing colleagues showcasing some of the fantastic work they do. Of course, a major part of attending the conference is the invaluable networking opportunity it gives us. It's always great to meet our own colleagues both new and old.”

Yvonne Cummins - Senior Pharmacist, Our Lady of Lourdes Hospital Drogheda

The team at Fresenius Kabi Ireland would like to thank the organising committee of BOPA 2023 and the staff at the ICC for their assistance and hospitality.

BOPA: British Oncology Pharmacy Association, CAR-T: Chimeric Antigen Receptor T, ICC: International Conference Centre, TIL: Tumour-Infiltrating Lymphocytes, ATMPs: Advanced Therapy Medicinal Products, SACT: Systemic Anti-Cancer Therapy.

and information. All in all, a very successful weekend with plenty of food for thought!

Irene Maher - Chief II Pharmacist, Cancer Services, Mercy University Hospital “Many thanks to FK team for providing me with the opportunity to participate in the BOPA symposium and for their exceptional care. The conference not only provided a fantastic networking platform but also highlighted the common challenges we all encounter in managing capacity and adapting to evolving treatments. The program offered in-depth updates on both current and upcoming best practices in cancer treatments, coupled with exciting glimpses into the future of this field. I found it exceptionally valuable to connect and interact with fellow colleagues.

Bruno Delgado – Pharmacist, St Vincent’s Private Hospital “BOPA as always was both educational and enjoyable. Love the mix of clinical, research, hot topics and extending pharmacy role sessions offered. It's great to have an opportunity to learn about the research, development, and innovative projects that our UK colleagues are involved in. I always find it thought provoking.

Hopefully, we have all taken away some useful information and ideas to help us in our own practice.

Unfortunately, we also learned that

Pictured above from left to right: Derek Kelly (FK), Rachel Wright (FK), Keith Sheridan (FK), Olivia Flynn (UHL), Eoin Tabb (UHW), Megan Hockly (UHG), Yvonne Cummins (OLOL), Bruno Delgado (SVPH), Hannah O’ Connor (SVUH), Irene Maher (MUH) and William Twaddle (FK).

Fresenius Kabi Limited - Fresenius Kabi Irelan

| F: +353 (0)1Dublin, 8496949 |Ireland E: FK-enquiries.Irelan Fresenius Kabi Limited - Fresenius Kabi Ireland, Unit 3B Fingal Bay, Balbriggan, Co. T: +353 (0)1 8413030 | F: +353 (0)1 8496949 | E: FK-enquiries.Ireland@fresenius-kabi.com | Job Code: IE-Onco-2300002, Date of Preparati www.fresenius-kabi.com/ie/

Job Code: IE-Onco-2300002, Date of Preparation: November 2023

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

38 ESMO 2023

Prostate Cancer Trials presented at ESMO 2023 Himisha Beltran,MD, Dana-Farber Cancer Institute, discussing data from trials during the Mini Oral Session - Genitourinary tumours prostate at ESMO Congress 2023, taking place in Madrid, Spain (20-24 October) instability. Beyond these patients, the challenge now will be to understand if there are other novel combinations that can sensitise to immunotherapy and identify the patients who may benefit from these treatments.”

Negative trials presented at the ESMO Congress 2023 suggest that a new treatment strategy may be required for patients with metastatic disease Although checkpoint inhibitors have shown remarkable efficacy in many solid tumours, their performance in prostate cancer has been disappointing so far.

Some preliminary evidence has suggested a potential synergy between androgen receptor pathway inhibitors (ARPIs) and PD-1-targeted therapies (J Clin Oncol. 2018;36_suppl 15:5047; Ann Oncol. 2020;31_suppl 4:625P). However, the latest findings from several clinical trials presented at the ESMO Congress 2023 (Madrid, 20–24 October) cast doubt on the efficacy of this combination of therapies in both metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC).

24.7 months versus 27.3 months, respectively; HR 1.04, 95% CI 0.88−1.22). Moreover, there was an increase in the incidence of treatment-related adverse events (TRAEs) with the addition of pembrolizumab compared with placebo plus enzalutamide. Dr Himisha Beltran from the DanaFarber Cancer Institute, Harvard Medical School, Boston, USA, notes: “Although the results from this trial were negative, hopefully there are still lessons we can learn.

We know that a small number of patients respond very well to immunotherapy and some of these harbour tumour mismatch repair deficiency or microsatellite

In addition, the results of the combination of pembrolizumab plus enzalutamide in 1,251 patients with mHSPC in the phase III KEYNOTE-991 study were presented, with the trial failing to reach its primary endpoint of rPFS (HR 1.20, 95% CI 0.96–1.49) and forcing its early termination for futility (Abstract 1772MO). An increase in TRAEs with pembrolizumab was again observed. Similar results were reported in a poster presentation of the pilot phase of the PROSTRATEGY study of ipilimumab and/or nivolumab combined with ADT plus docetaxel in 150 patients with high-volume mHSPC (Abstract 1783P). After a median follow-up of 32.5 months, no significant differences in efficacy outcomes, including rPFS, clinical PFS and OS, were detected between treatment arms.

Commenting on these findings, Beltran says, “We had hoped to obtain more positive results in mHSPC. These trials were based on the scientific premise that primary ADT increases immune infiltration in tumours, which can be further enhanced by immune modulators, such as enzalutamide or docetaxel, potentially enhancing response to immunotherapy.

However, the results for both of these studies were negative.

Overall, these studies are adding to an overall landscape of negative trials for immunotherapy in prostate cancer. Other trials are ongoing, but as a field, we may need to rethink our strategy for these patients.”

Regarding the possible reasons why patients with prostate cancer are not responding to immunotherapy in these trials, Beltran suggests: “It may be that only a fraction of patients are responding to treatment or perhaps the immune effects elucidated from the combination are too transient or that immunosuppressive cells still predominate. Looking ahead, it is essential that we work to better understand mechanisms of resistance to immunotherapy, find ways to improve patient selection and also that we consider different combinations of therapies, including those that target novel pathways.”

Figure. No difference in overall survival for patients with metastatic castration-resistant prostate cancer treated with pembrolizumab plus enzalutamide versus placebo plus enzalutamide in the KEYNOTE-641 study (ESMO Congress 2023, Abstract 1771MO)

As presented in a Mini Oral Session, the phase III KEYNOTE-641 study, which investigated the combination of pembrolizumab and enzalutamide versus placebo plus enzalutamide in 1,244 patients with mCRPC failed to meet its dual primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) (Abstract 1771MO). The modest increase in complete response rate with pembrolizumab plus enzalutamide versus placebo plus enzalutamide (7.4% versus 2.7%, respectively) did not translate into significant increases in rPFS (median 10.4 months versus 9.0 months, respectively; hazard ratio [HR] 0.98, 95% confidence interval [CI] 0.84−1.14) or OS (median DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

Rapid, sustained, surge free testosterone suppression

One oral ADT

*

Introducing ORGOVYX® the one & only oral ADT for advanced hormone sensitive prostate cancer.1,2 Achieve rapid, sustained and surge-free testosterone suppression.3

ORGOVYX®

The First & Only Oral ADT Tablet not to size.

ABBREVIATED PRESCRIBING INFORMATION Please refer to the Summary of Product Characteristics (SmPC) before prescribing ▼Orgovyx 120 mg film-coated tablets Presentation: Each tablet contains 120mg of relugolix. Indications: For the treatment of adult patients with advanced hormone-sensitive prostate cancer.

Dosage and Administration: Treatment with Orgovyx should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer. Treatment should be initiated with a loading dose of 360 mg (three tablets) on the first day, followed by a 120 mg (one tablet) dose taken once daily at approximately the same time each day. Because relugolix does not induce an increase in testosterone concentrations, it is not necessary to add an anti-androgen as surge protection at initiation of therapy. Dose modification for use with P-gp inhibitors Coadministration of Orgovyx with oral Pglycoprotein (P-gp) inhibitors must be avoided.

If co-administration is unavoidable, Orgovyx should be taken first and dosing should be separated by at least 6 hours. Treatment with Orgovyx may be interrupted for up to 2 weeks if a short course of treatment with a P-gp inhibitor is required. Dose modification for use with combined P-gp and strong CYP3A inducers Co-administration of Orgovyx with combined P-gp and strong cytochrome P450 (CYP) 3A inducers must be avoided. If co-administration is unavoidable, the dose of Orgovyx must be increased to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, the recommended 120 mg dose of Orgovyx once daily must be resumed. Missed doses If a dose is missed, Orgovyx must be taken as soon as the patient remembers. If the dose was missed by more than 12 hours, the missed dose must not be taken and regular dosing schedule should be resumed the following day.

If treatment is interrupted for over 7 days, Orgovyx must be restarted with a loading dose of 360 mg on the first day, followed with a dose of 120 mg once daily. Elderly No dose adjustment is required. Renal impairment No dose adjustment in patients with mild, or moderate renal impairment is required. Caution is warranted in patients with severe renal impairment. Hepatic impairment No dose adjustment in patients

with mild or moderate hepatic impairment is required. Paediatric population There is no relevant use of Orgovyx in children and adolescents under 18 years of age for the indication of treatment of advanced hormone sensitive prostate cancer. Method of administration Oral use. Orgovyx can be taken with or without food. Tablets should be taken with some liquid as needed and swallowed whole. Contraindications: Hypersensitivity to the active substance or to any of the excipients, see SmPC for further details.Warnings and Precautions: Effect on QT/QTc interval prolongation Androgen deprivation therapy may prolong the QT interval. In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval, physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Orgovyx.

A thorough QT/QTc study showed that there was no intrinsic effect of relugolix on prolongation of the QTc interval. Cardiovascular disease Cardiovascular disease such as myocardial infarction and stroke has been reported in patients with androgen deprivation therapy. Therefore, all cardiovascular risk factors should be taken into account. Changes in bone density Long-term suppression of testosterone in men who have had orchiectomy or who have been treated with a GnRH receptor agonist or GnRH antagonist is associated with decreased bone density, which, in patients with additional risk factors, may lead to osteoporosis and increased risk of bone fracture.

Hepatic impairment Patients with known or suspected hepatic disorder have not been included in long-term clinical trials with relugolix. Mild, transient increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been observed but were not accompanied by an increase in bilirubin or associated with clinical symptoms.

Monitoring of liver function in patients with known or suspected hepatic disorder is advised during treatment. The pharmacokinetics of relugolix in patients with severe hepatic impairment has not been evaluated. Severe renal impairment Exposure to relugolix in patients with severe renal impairment may be increased by up to 2 fold.

Because a lower dose of relugolix is not available, caution in patients with severe renal impairment is warranted upon administration of a 120 mg dose of relugolix

Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie), or by e-mailing medsafety@hpra.ie. Adverse events should also be reported to Medical Information via email; medinfo@accord-healthcare.com or tel:0044 (0) 1271 385257

once daily. The amount of relugolix removed by haemodialysis is unknown. Prostatespecific antigen (PSA) monitoring The effect of Orgovyx should be monitored by clinical parameters and prostate-specific antigen (PSA) serum levels. Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’. Fertility, Pregnancy and Lactation: This medicinal product is not indicated in women of childbearing potential. It is not to be used in women who are, or may be, pregnant or breast-feeding. Effective contraception must be used during treatment and for 2 weeks after the last dose of Orgovyx. Orgovyx may impair fertility in males of reproductive potential. Refer to SmPC. Adverse events include: Adverse events which could be considered serious include; Common: Anaemia, Hypertension, Glucose increased Rare: Myocardial infarction. Unknown: QT prolonged. Other Very Common adverse events: Diarrhoea (inc colitis), Musculoskeletal pain (inc arthritis), Hot flush, Constipation, Fatigue. Other Common adverse events: Gynaecomastia, Insomnia, Depression, Dizziness, Headache, Nausea, Hyperhidrosis, Rash, Libido decreased, Weight increased, Triglyceride increased, Blood cholesterol increased. Other Uncommon adverse events: Osteoporosis/osteopenia, Aspartate aminotransferase increased, Alanine aminotransferase increased. Shelf Life: 36 months. Pack size: 30 and 90 (3 packs of 30) film-coated tablets. Marketing Authorisation Holder (MAH): Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain.MA Number: EU/1/22/1642/001, EU/1/22/1642/002. Legal Category: POM. Full prescribing information including the SmPC, is available on request from Accord Healthcare Ltd, Euro House, Little Island, Co. Cork, Tel: 021-4619040 or www.accord-healthcare. ie/products. Adverse reactions can be reported to Medical Information at Accord Healthcare Ltd. via E-mail: medinfo@accord-healthcare.com or Tel: +44(0)1271385257.

Date of Generation of API: April 2023 IE-02042 ADT: Androgen Deprivation Therapy. * 1. ORGOVYX® Summary of Product Characteristics.

2. Fragkoulis C, et al. Arab J Urol. 2021;19(4):460–463.

3. Shore ND, Saad F, Cookson MS, et al. N Engl J Med. 2020;382(4):2187–2196.

June 2023. IE-02064

40 Lung Cancer

Lung cancer awareness at the Irish Cancer Society Written by Aoife Mc Namara, Education and Engagement Manager, Irish Cancer Society

November was global lung cancer awareness month. As part of its annual awareness campaign, the Irish Cancer Society (the Society) highlighted the importance of early detection and the many barriers that prevent it, including stigma.

Lung cancer is one of the most common cancers worldwide. In Ireland, lung cancer is the fifth most common cancer, with almost 2,700 people diagnosed each year.

Less than a third of lung cancer patients are diagnosed at an early stage. Later diagnosis means more challenging disease management and little chance of cure. Sadly, more Irish people die from lung cancer than from any other form of the disease.

Early detection is vital. Multiple global large-scale studies have conclusively shown that lung cancer screening works in detecting more lung cancers at earlier stages. However, in the absence of a national screening programme, early detection in Ireland is reliant on patients presenting to their GP sooner rather than later. Despite multiple annual awareness campaigns, recent data shows people are often still unclear of the signs and symptoms. When they do notice something wrong, it is well documented that patients can delay presentation because of the stigma associated with lung cancer and smoking.

The Global Lung Cancer Coalition (GLCC) is an alliance of patient organisations committed to increasing awareness and understanding of lung cancer and campaigning to improve lung cancer outcomes for all. In 2023, the GLCC commissioned a

multi-national study to understand attitudes towards lung cancer, levels of symptom awareness among the public and views on lung cancer screening. The study was undertaken in 29 countries, including Ireland. Responses were received from at least 1,000 adults per country. Data was weighted using age, gender and region to produce a representative sample in each country.

self-inflicted disease. No other cancer suffers from the same level of blame.

Early detection of lung cancer is vital, now more than ever.

Preliminary data from the National Cancer Registry of Ireland earlier this year confirmed that 14% less lung cancer cases were diagnosed in 2021 than projected because of the impact of the pandemic. Our clinical colleagues are reporting more delayed diagnoses and poorer survival outcomes because of this. Our message all year round, but especially during Lung Cancer Awareness Month, is that members of the public should to be aware of the signs and symptoms of lung cancer and if or when they notice any of these symptoms, they should engage with their GP immediately.

The Irish Cancer Society has long supported the introduction of lung cancer screening to save lives and continues to call for the

Over 28% of Irish respondents said they did not know any symptom of lung cancer.

Worryingly those at highest risk, people who currently smoke/ have smoked were more likely to report not knowing any symptoms compared to people who have never smoked (30.69% v 23.58%). To understand attitudes to lung cancer, participants were told that: “Lung cancer is mainly caused by smoking cigarettes and other tobacco products”. They were then asked, whether they have less sympathy for people with lung cancer than other types of cancer. In Ireland, 39.92% agreed with the statement that they had less sympathy for people with lung cancer.

Public health campaigns around the world have traditionally highlighted the link between tobacco and lung cancer in an effort to educate on risk reduction.

However, many now argue that this public health approach has in fact led to the stigmatisation of lung cancer patients. Stigma is not normally associated with other cancers, yet on hearing a lung cancer diagnosis, people often respond with ‘Did they smoke?’ The strong association between tobacco and lung cancer has created the belief that it is a

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

Government and the National Screening Service to work together to launch lung cancer screening.

In the GLCC study, 88.82% people agreed there should be a national lung cancer-screening programme to help people with lung cancer get diagnosed early.

Throughout November and into December, the Irish Cancer Society will be hosting a series of Lung Cancer Awareness Road Shows and is calling on the public in these locations to come along, ask questions and meet with our cancer nurses. Our Support Line nurses are available to talk to anyone who is concerned about lung cancer on Freephone 1800 200 700, Monday – Friday.

For more information and support, visit www.cancer.ie/lung For more information about this study and the work of the GLCC please visit: www.lungcancercoalition.org

Heart Health 41

Irish Heart Foundation Patient Support Services Cardiovascular disease is responsible for some 9,000 deaths in Ireland each year – around 30% of all mortality. Over half a million people are living with a cardiovascular condition, with 80,000 being discharged from hospital each year, often returning home to a bleak and uncertain future.

Whilst stroke and heart failure supports are our primary focus, we are also developing services across a broad range of cardiovascular conditions, including heart attack, people with cardiomyopathies and congenital heart disease, families affected by sudden cardiac death and people with ICDs.

Among stroke survivors, there’s a widespread sense of abandonment resulting from a dearth of rehabilitation and other crucial services and supports in the community crucial to meet the challenges of often significant physical, communication, social and psychological difficulties. In the last decade stroke mortality has fallen by around a third whilst stroke incidence is up by around 25%. But there has been no significant investment in post-discharge services to meet the rapid rise in numbers returning home.

Thanks to a system of referral that is strongly supported in stroke units and heart failure services, we have access for the first time to patients when they need help most – in the weeks after discharge or step down from their clinical support. This has enabled us to develop pathways for both stroke and heart failure from the hospital gates for as long as people need us.

Meanwhile, heart failure patients must endure the revolving door syndrome of a 90-day readmission rate to hospital of 30% that is seriously detrimental to their quality of life, often for the want of basic information and support.

These services are delivered separately – reflecting differing patient needs and in order to maximise the proven impact of peer support. Despite this, the main service elements are the same.

They incorporate: - Nurse-led needs assessments and regular support calls through our Stroke Connect and Heart Connect programmes

Against this backdrop, the Irish Heart Foundation established specific pathways of support for stroke survivors and heart failure patients that are impactful, cost-effective and can be delivered at scale.

- Short duration interventions meeting specific needs

In the last 12 months these services, launched following the outbreak of Covid-19, have enjoyed enormous growth and now support around one in every three stroke survivors returning home from hospital nationally, along with thousands of heart failure and other cardiac patients.

- Peer to peer phone support

Our services prevent hospital readmission among heart failure patients, reduce the requirement for long-term care among stroke survivors and remove a significant burden from frontline services.

They empower patients to take control of their own health and wellbeing but ensure that where their conditions are deteriorating, they are appropriately escalated without delay. It’s important to stress that the Irish Heart Foundation provides non-clinical psychosocial support services that don’t overlap with any other clinical services.

- Younger patient networks - Face-to-face groups - Online support

- Stay Connected low support programme Stroke Connect and Heart Connect Both services start with a nurseled needs assessment conducted by phone. Stroke survivors receive up to eight weekly phone calls from our support coordinators and trained volunteers who provide emotional support, quality information and guidance, help to meet recovery goals and signposting. The heart failure calls are monthly and involve a greater emphasis on reiterating consistent health messages from heart failure clinics in relation to symptom recognition and self-care, along with information and emotional support. Our nurses remain available to provide general health advice and information as required.

Written by Chris Macey, Director of Advocacy and Patient Support with the Irish Heart Foundation

The service includes a traffic light system to escalate calls where there is a medical concern.

This has provided a robust early warning system for patients who may turn out to be at risk of recurrent stroke or deterioration among heart failure patients.

We also actively signpost our members to other community supports and organisations such as the HSE community programme, Family Carers Ireland, Social Prescribing and Citizens Information.

Short programmes In the course of these calls patients are offered counselling if appropriate and when they have concluded, we discuss further service options, including a menu of short programmes where a specific need has been identified, which typically run for between 6-12 weeks and include:

programmes. These include information sessions and social groups which are very popular in older age groups. We have three moderated closed Facebook groups for heart failure, stroke and our carers networks, which provide a vibrant source of peer support, evidenced by high daily engagement rates. Specific online supports for heart failure patients include a fluid tracker app; symptom checker and an online cardiac rehab programme developed with the Irish Association of Cardiac Rehabilitation.

Peer to peer phone support We provide peer to peer support delivered one-to-one by phone by fully trained stroke survivor and heart patient volunteers, many of whom have been through our services and who give their time both to give something back and to help meet their own recovery goals.

- Fatigue Management

Working age support networks

- Back to Work

We have a dedicated working age stroke support network to meet the needs of survivors who now account for more than a quarter of all strokes in Ireland. The HSE estimates that 1% of under 65s in Ireland have heart failure – as many as 43,000 people and a support group to meet their needs in now being established.

- Mindfulness - Cognitive therapy - Physical Exercise - Psychological support - Communication - Art and Music therapy We also facilitate referral to the HSE Living Well, Living Well with a Cardiac Condition and Building Better Caregivers programmes.

Online support programmes Members are given access to a suite of online support

Face to face support groups Our face to face stroke groups are back in action after Covid, along with our nationwide series of heart failure information meetings. We currently have 20 face to face stroke groups around the country, including two for younger survivors.

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

42 Heart Health Stay Connected programme Stay Connected is for members who are not actively using our services but who want to stay in touch and have the option to re-connecting fully at a later date. They receive a low support service intervention that includes a quarterly newsletter, access to our nurse support line, our full range of digital and print resources and our calendar of events. Crucially, they can also access our services if their circumstances change.

Information Providing access to accurate, authoritative and easy to understand information is one of

the most important services we can deliver.

- A team of nurses work on our Nurse Support Line, supporting the public, along with our service users.

- We distribute over a half a million leaflets and educational materials each year that give people affected by cardiovascular disease the information they need to live well.

- And our website and social media platforms are key resources for patients, families and carers, together with healthcare professionals and the

general public. We have over 100,000 followers on our social media platforms and there are more than 250,000 annual visits to our website.

Carer supports We provide specific support for carers of both heart and stroke patients through Facebook and other online services. These include: - Support Pack - Peer Facebook community - Information Zoom Sessions - Signposting to external supports - Access to Nurse Support Line

Our services are proving their impact through significant reductions in requirement for long-term care and hospital readmission; they cost a fraction of the increased capacity they are providing in hospitals and nursing homes; and they are built to be delivered at scale.

Our next objective is to forge a long-term partnership with the HSE to deliver sustainable high grade support. This will ensure that at last cardiovascular patients emerge from the lowest rung of priority in the provision of essential community services and supports perhaps of any serious chronic condition, enabling them to live the best life possible with the effects of heart disease and stroke.

News Misbeliefs and Serious Lack of Symptom Awareness Liz Yeates, CEO Marie Keating Foundation, lung cancer patient, Ted O'Driscoll, and awareness advocates, Venetia Quick and Catherine O'Flaherty, kicking off Lung Cancer Awareness Month Picture Andres Poveda

Only 5% of Irish people are aware that lung cancer is the leading cause of cancer related deaths among women, while just 20% know that it is the cancer that claims the most lives among men.

The figures were revealed in new research commissioned by the Marie Keating Foundation who have issued a stark warning that Ireland is not making satisfactory progress on lung cancer, stating that “lung cancer death rates remain shockingly high, while symptom awareness is alarmingly low.”

As part of its ‘Big Check Up 2023’ campaign, the charity has outlined

a three-point action plan that it says will save countless lives now and in the future.

The action plan aims to: 1) change how we see lung cancer, countering the misbelief that there are more dangerous cancers for both men and women and highlighting the fact that lung cancer still claims more lives than any other cancer; 2) raise lung cancer symptom awareness, harnessing the use of innovative, specially developed, new mobile technology in partnership

with Snapchat, to spotlight symptoms and urge people to get checked; 3) renew pressure on the Government to introduce a National Lung Cancer Screening programme, similar to breast, bowel and cervical cancer screening, to help save lives.

Launching the campaign, Liz Yeates, CEO of the Marie Keating Foundation, said, “The time has come to change how people see lung cancer, to raise public awareness and encourage those with lung cancer signs and symptoms to get checked, because early detection, combined

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

with all of the new treatments available, significantly improves chances of positive outcomes.”

Currently in Ireland, the 5-year survival rate for lung cancer patients is just 24%. This is extremely low compared with other five-year survival rates for common cancers such as, Prostate: 93%, Breast: 88% and Colorectal: 66%.

Furthermore, the National Cancer Registry of Ireland has predicted that rates of lung cancer will rise rapidly by 2045, with lung cancer diagnoses expected to increase by as much as 176% among women, and by 94% among men.

Supporting the campaign, Professor Jarushka Naidoo, Professor of Medical Oncology and Consultant Medical Oncologist at Beaumont RCSI Cancer Centre, Lung Cancer Chair for Cancer Trials Ireland and Adjunct Assistant Professor of Oncology at Johns Hopkins University said: “Early detection can save lives.

When lung cancer is found at an earlier stage, there is a better chance of the ability to deliver treatments with the intent of cure.

We have seen an explosion of new treatment options for patients with lung cancer. We need to give patients a chance to receive these therapies, by identifying lung cancer earlier, and more able to tolerate treatment. Evidence from other countries shows that early detection programmes can pick up lung cancer early, and result in improved patient outcomes.”

CPD 103: ATRIAL FIBRILLATION Continuing Professional Development

43

AUTHORS: Written by Dr. Dara Chesser, Dr. Rayka S. Modabberi and Dr. Usama Boles

CPD 60 Second Summary Atrial fibrillation (AF) is recognised as rapid, irregular atrial contractility.

AF is the most common cardiac arrhythmia, it is estimated to effect 60 million worldwide, and the estimated prevalence in Ireland is, according to the Central Statistics Office, 3.2% of people over 50 years of age and is predicted to represent between 21.5 and 27.9% of the population in 2046that over 65’s. AF is a growing public health concern in Ireland.

Rhythm strategy in AF management have resulted in significant reduction heart failure presentation, hospital re admissions, cerebroembolic stroke and improved the quality of life to many affected patients with AF. Early Rhythm strategy also helps to prevent cardiovascular (CVD) and its progression, by limiting the structural changes that can occur with AF. Underlying genetic susceptibility with traditional risk factors leads to initiation and perpetuation of AF, also known as the “two-hit hypothesis”.

Therefore, strategies to intervene with AF and convert patients in SR are dependent on early substrate modification and termination of AF. Catheter ablation is especially useful in patient with concomitant Heart Failure (HF). It’s been shown to reduce risk of cardiac hospitalisation, recurrent atrial arrhythmia all-cause mortality, and improve LV function in the setting of reduced Ejection fraction.

Ablation focuses mainly on triggers isolation (pulmonary veins potentials) within the pulmonary vein myocardial sleeves, a technique known as Pulmonary vein isolation (PVI). With the assistance of intraprocedural echocardiography, the left atrium and the pulmonary vein is mapped out.

The future is so promising in this ablation era, with innovative technology to benefits of rhythm strategy, particularly early rhythm strategy are well established.

The role of catheter ablation in this capacity is promising and increasingly is being proven safer, efficatious and superior to AADs without the added adverse effects.

Dr. Dara Chesser, Cardiology SHO, Tipperary University Hospital, Clonmel

Dr. Rayka S. Modabberi, Cardiology Intern, Tipperary University Hospital, Clonmel

1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice?

knowledge gap - will this article satisfy those needs - or will more reading be required?

2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.

4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result?Have I identified further learning needs?

3. PLAN - If I have identified a

5. WHAT NEXT - At this time you may like to record your learning for future use or assessment. Follow the

Usama Boles MSc, PhD, FRCPI, FHRS, FESC, FEHRA, Consultant Cardiologist and Electrophysiologist, Senior Lecturer RCSI, Cardiology Department, Tipperary University Hospital, Clonmel 4 previous steps, log and record your findings.

Published by HPN. Copies can be downloaded from www.irishpharmacytraining.ie Disclaimer: All material published is copyright, no part of this can be used in any other publication without permission of the publishers and author.

Rhythm Strategy and Catheter Ablation Role in Atrial Fibrillation Management; A Systemic Review to the Most Recent Trials Atrial fibrillation; disease burden and prevelance Atrial fibrillation (AF) is recognised as rapid, irregular atrial contractility.1 AF is the most common cardiac arrhythmia, it is estimated to effect 60 million worldwide, and the estimated prevalence in Ireland is ,according to the Central Statistics Office, 3.2% of people over 50 years of age and is predicted to represent between 21.5 and 27.9% of the population in 2046 that over 65’s.

AF is a growing public health concern in Ireland.2, 3 AF reduce quality of life, cardiovascular death and heart failure.4, 5 AF is also a risk factor for ischaemic stroke leading to disability (figure 1).6, 7 The European Society of Cardiology AF guidelines state that rhythm control is indicated “to reduce AF-related symptoms and improve Quality of Life”8 and recommendation for AF rhythm strategy as a means to reduce mortality in HF patients.9, 10 Rhythm Strategy, Vs. Rate controle In Atrial fibrillation followup investigation of Rhythm

management (AFFIRM) study, clearly demonstrated that preservation of SR is associated with cardiovascular risk reduction of approximately 46%.11 The Catheter Ablation Versus Medical Rate control in Atrial Fibrillation and systolic Dysfunction (CAMERAMRI) study, showed left ventricular ejection fraction (LVEF) improved at 6 months in catheter ablation arm versus rate control therapy (mean difference in ejection fraction 14%; CI [8.5-19.5%]).12 Rhythm strategy in AF management have resulted in significant reduction heart failuire presentation, hospital re admissions, cerebroembolic stroke and improved the quality of life to many affected patients with AF. Advantages of Early Rhythm Strategy Early Rhythm strategy also helps to prevent cardiovascular (CVD) and its progression, by limiting the structural changes that can occur with AF.13 Underlying genetic susceptibility with traditional risk factors leads to initiation and perpetuation of AF, also known as the “two-hit hypothesis”.14 Therefore, strategies to intervene

with AF and convert patients in SR are dependent on early substrate modification and termination of AF. This was demonstrated in the Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure (RACE 3) study which showed treatment of comorbid conditions improves SR maintenance in persistent AF.15 Patients involved in CAMERAMRI study had minimal ventricular fibrotic myocardial remodelling, demonstrated on cardiac MRI. But, this only highlights the importance of early conversion to SR in AF, prior to morphological changes and scarring.12 Likewise, Early Rhythm-Control Therapy in Patients with Atrial Fibrillation (EAST-AFNET 4) trial ,that was funded by german government, revealed Early rhythm-control therapy was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients with early atrial fibrillation and cardiovascular conditions. This trial represent a real life date incluiding a large cohort of patients over 135 centres.

44

CPD 103: ATRIAL FIBRILLATION Figure 1: Cardiovascular outcome of Atrial fibrillation Burden and the impact of ablation for worsening HF. There was an improved LV function in the ablation group with reduced AF burden.10 Of course, there has been acceptable criticism of the study design in that on the ablation arm of the trial, patients were young, make, with less severe HF.27 The AATAC trial demonstrated similar results to the CASTLE-AF trial in terms of improved LV function with reduced mortality in the patients with AF who received ablation.28 Again, this improvement in LV function following catheter ablation compared to rate control was noted in the CAMERA-MRI study.12

Logically, the impact of reducing AF burden on health care budget is expected to be extremely impactful.16 Additionally, early rhythm strategy by CA has led to a 70-80% reduction in those with paroxysmal AF.17, 18 In persistent AF, however, CA is likely to have a lower success rate of 50% when the duration of AF is so prolonged, hence additional approaches during ablation and add on AADs are all visited in a trial to improve the success rate.19 Traditionally, the approach is to use antiarrhythmic drugs (AAD) to treat AF and maintain SR, the efficacy ranges from 19% to 60%, depending on the AAD, and is unlikely to cease the AF, rather reduce the AF burden (symptoms).20 Also, it is well known that AAD have some concerns in

Figure 2: left showing Pulse Field Ablation catheter(PFA); 3D mapping to localize the catheter location around PV . Right , PFA delivered and Pulmonary vein potentials “Red arrows” have been ablated “arrows in Green”. LA “Left Atrium”, RPVs “Right Pulmonary Veins”, LPVs “Left Pulmonary Veins” and LAA “Left Atrial Appendage”

The Catheter Ablation versus Antiarrhythmic Drug Therapy in Atrial Fibrillation (CABANA) study included patients with new-onset or untreated AF and increased cardiovascular risk. It randomly assigned patients to either catheter ablation or drug therapy.29 There was a significant reduction in the cardiovascular death, hospitalisations, AF recurrence and quality of life in terms of symptom relief. It did not demonstrate any benefit in the primary endpoints such as overall all cause of mortality.30 It’s worth noting that this was a study on relatively young patients with only 25% of patient having previously diagnosed HF.

regards to side effects, , such as proarrhythmia, extracardiac side effects and mortality.21, 22 It’s also been stated that much AAD use is empirical and not arrhythmia or patient focused.23

arrhythmia all-cause mortality, and improve LV function in the setting of reduced Ejection fraction.24, 25, 26 This was further proven in Cather Ablation for Atrial Fibrillation with Heart Failure (CASTLE-AF), where patients were randomised into an The role of Catheter ablation ablation group or a conventional therapy group, and followed for 36 However, the benefits of catheter Catheter ablation is especially months. This study demonstrated ablation versus AADs in terms of useful in patient with concomitant a 38% risk reduction and 47% reducing AF burden in patients Heart Failure (HF). It’s been relative risk all-cause with paroxysmal was further shown toleft reduce risk of cardiac Figure 2: showing Pulse Field Ablation catheter(PFA); 3D reduction mapping to in localize the catheter location around PV . AF Right , PFA delivered hospitalisation, recurrent atrial mortality and hospital admission demonstrated the RAAFT – 1LPVs and Pulmonary vein potentials “Red arrows” have been ablated “arrows in Green”. LA “Left Atrium”, RPVs “RightinPulmonary Veins”, “ Left Pulmonary Veins” and LAA “Left Atrial Appendage”.

LAA

LPVs

LA

RPVs

Fig 3:High power (90 W) short duration (4 seconds) radiofrequency lesions in dotted Red with 3D CARTOTM mapping using.

45

Fig 3: High power (90 W) short duration (4 seconds) radiofrequency lesions in dotted Red with 3D CARTOTM mapping using and RAAF-2 trials. Patients who had not been treated for AF previously were included in both studies. RAAFT -1 significantly reduced the number of patients in AF treated with catheter ablation compared with AADs. Lokewise, RAAFT-2 catheter ablation has superior effect than AADs in SR maintinance. Based on RAAFT-2, it may be reasonable to consider catheter ablation as first-line for younger patients, who are highly symptomatic, paroxysmal AF without structural cardiac damage and a normal left atrium size, who would prefer not to take AADs and tachycardiomyopathy solely related to AF. It is also ideal to minimise triggers like sleep apnea, hypertension controle and improve lifestyle incluiing obesity.31, 32

oesophageal luminal temperature point ablation, whereas cryotherapy with probes.33 uses a inflated balloon to quickly However, interventional options ablate the triggers identified.33 are safe, potential low risk of Current Techniques complications are encountered Neuromodulation, via stimulation Ablation focuses mainly on like, embolic stroke however, of the vagus nerve could be intercardiac/transiesohageal triggers isolation (pulmonary veins a potential new approach to echocardiogram, as well as close potentials) within the pulmonary ablation, as this approach has management of anticoagulation. vein myocardial sleeves, a been shown to suppress AF.34 Also, Phrenic nerve injury, but technique known as Pulmonary high-output pacing should be Ablation future and saftey vein isolation (PVI). With the used to identify proximity of assistance of intraprocedural A- Pulse field ablation: nonthese structures to ablation site. echocardiography, the left atrium thermal ablative modality It should also be noted that injury and the pulmonary vein is mapped that is highly safe as it is to phrenic nerves usually recover out. The current techniques to tissue selective Irreversible spontaneously. Finally, a rare but ablate include radiofrequency electroporation apoptosis of the potentially fatal adverse effect is (RF) and more recently balloon antral endocardial cells, which atrioesphogeal fistula. This can be avoided by monitoring thefor VT ablation. cryotherapy.

RF uses point-byuse of direct current Figure 4,A : Coherence mapping The map propagation(left) alongside standard is EPSthe assessment to identify target(DC) for ablation. Red spots reflect ablation points. Color code where earliest part of VT cycle in red. Map on right reflects voltage mapping, where red indicates scar area (low voltages area)

Propagation map

Voltage map

Aorta

Left Ventricle

energy to cause programmed cell death. This approach limits collateral damage of non-target tissue such as the oesophagus and phrenic nerve and hence avoids complications (Fig 2).35 B- High power- Short duration: Recently, the novelty of high power (90 watts) and short duration (4 seconds) reduced the ablation phase to average of 5 mins, leading to oveall reduced procedures time and hence rapid recovery is expected. This technology proved high saftey profile and hence can be provided to wide range of population (Fig 3).

C- High definition mapping and advance in technology to upstream performance during cath lab interventional electrophysiology procedures.

It have improved rhythm identifcations, mechanism and accurately localize the target for ablation. That has impact on procedures saftey as well as shorter procedure time with higher success rates (Fig 4 A&B)

Figure 4, A: Coherence mapping for VT ablation. The map propagation(left) alongside standard EPS assessment to identify target for ablation. Red spots reflect ablation points. Color code where earliest part of VT cycle in red. Map on right reflects voltage mapping, where red indicates scar area (low voltages area)

46

CPD 103: ATRIAL FIBRILLATION

Fig 4, B: RhythmiaTM 3D mapping to localize focal fast AT at the anterior Carina region of left pulmonary veins Corresponding to earliest fractionated signal

Fig 4, B: RhythmiaTM 3D mapping to localize focal fast AT at the anterior Carina region of left pulmonary veins Corresponding to earliest fractionated signal The future is so promising in this ablation era, with innovative technology to benefits of rhythm strategy, particularly early rhythm strategy are well established.

The role of catheter ablation in this capacity is promising and increasingly is being proven safer, efficatious and superior to AADs without the added adverse effects.

The healthcare impact on assertive treatemen for AF by catheter ablation is well enumerated above and hence further strategies to focus on effective strategies will provide positive impact.

Table 1: Table of common trials comparing rhythm startegy Vs. rate controle only and outcome Paper

Year

Cohort

Aim

Conclusion

In favor of

Catheter Ablation versus Medical Rate Control in Atrial Fibrillation and Systolic Dysfunction: the CAMERA-MRI Study11

2017

68

“To determine whether catheter ablation for AF could improve LVSD compared with medical rate control”.11

“Restoration of sinus rhythm with catheter ablation results in significant improvements in ventricular function”.11

Rhythm

A Randomized Trial of Circumferential Pulmonary Vein Ablation Versus Antiarrhythmic Drug Therapy in Paroxysmal Atrial Fibrillation: the APAF Study20

2006

198

To compare ablation strategy with antiarrhythmic drug therapy in individuals with paroxysmal atrial fibrillation.20

“Pulmonary vein ablation is more successful than antiarrhythmic drug therapy for prevention of paroxysmal atrial fibrillation”.20

Rhythm

Early Rhythm-Control Therapy in Patients with Atrial Fibrillation (EAST-AF trial)23

2020

2789

To determine whether early rhythm-control therapy including ablation would be associated with better outcomes in patients with early atrial fibrillation than the usual care.23

“Early rhythm-control therapy was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients with early atrial fibrillation and cardiovascular conditions”.23

Rhythm

A randomized controlled trial of catheter ablation versus medical treatment of atrial fibrillation in heart failure (the CAMTAF trial)26

2014

50

“To compare the effect of a catheter ablation strategy with medical rate control strategy in patients with persistent atrial fibrillation and heart failure”.26

“Catheter ablation is effective in restoring sinus rhythm in selected patients with persistent AF and HF, and can improve LV function, functional capacity, and HF symptoms compared with rate control”.26

Rhythm

Ablation versus amiodarone for treatment of persistent atrial fibrillation in patients with congestive heart failure and an implanted device: results from the AATAC multicenter randomized trial29

2016

203

To determine whether catheter ablation is superior to amiodarone for the treatment of persistent atrial fibrillation in individuals with heart failure.29

Catheter ablation is superior to amiodarone and reduces unplanned hospitalization and mortality in those with heart failure and persistent atrial fibrillation.29

Rhythm

Catheter Ablation versus Antiarrhythmic Drug Therapy in Atrial Fibrillation (CABANA) Trial30

2018

2200

To determine whether percutaneous left atrial catheter ablation for treatment of atrial fibrillation is superior to current pharmacologic therapy.30

“Ablation is not superior to drug therapy for cardiovascular mortality at 5 years among patients with new-onset or untreated atrial fibrillation, however less AF recurrence”.30

N/A

Radiofrequency Ablation vs Antiarrhythmic Drugs as First-line Treatment of Symptomatic Atrial Fibrillation: A Randomized Trial32

2005

70

“To determine whether pulmonary vein isolation is feasible as first-line therapy for treating patients with symptomatic atrial fibrillation”.32

Pulmonary vein isolation is a feasible first-line approach for treating individuals with symptomatic atrial fibrillation.32

Rhythm

Radiofrequency Ablation vs Antiarrhythmic Drugs as First-Line Treatment of Paroxysmal Atrial Fibrillation (RAAFT-2): A Randomized Trial33

2014

127

“To compare radiofrequency ablation with antiarrhythmic drugs (standard therapy) in treating patients with paroxysmal atrial fibrillation as a first-line therapy”.33

“Radiofrequency ablation resulted in a lower rate of recurrent atrial tachyarrhythmias at 2 years. However, recurrence was frequent in both groups”.33

Rhythm

References available on request

KEYTRUDA for advanced gastrointestinal cancers KEYTRUDA (Pembrolizumab) is approved for the treatment of:1 COLORECTAL CANCER

In combination with trastuzumab + chemotherapy, is indicated for 1L treatment of locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinomas in adults whose tumours express PD-L1 with a CPS ≥ 1.

KEYTRUDA® (pembrolizumab) ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing. PRESENTATION KEYTRUDA 25 mg/mL: One vial of 4 mL of concentrate contains 100 mg of pembrolizumab. INDICATIONS KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.

KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection. KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations. KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥1% TPS and who have received at least one prior chemotherapy regimen.

Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. KEYTRUDA as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10. KEYTRUDA as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1. KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic HNSCC in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy. KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults. KEYTRUDA, in combination with lenvatinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers Colorectal cancer (CRC) KEYTRUDA as monotherapy is indicated for adults with MSI-H or dMMR colorectal cancer in the following settings: - first line treatment of metastatic colorectal cancer - treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy. Non-colorectal cancers KEYTRUDA as monotherapy is indicated for the treatment of the following MSI H or dMMR tumours in adults with (a) advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation, (b) unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. KEYTRUDA, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 10. KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD L1 with a CPS ≥ 1. KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. DOSAGE AND ADMINISTRATION See SmPC for full details. Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. The recommended dose of KEYTRUDA in adults is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. The recommended dose of KEYTRUDA as monotherapy in paediatric patients aged 3 years and older with cHL or patients aged 12 years and older with melanoma is 2 mg/kg bodyweight (up to a maximum of 200 mg), every 3 weeks administered as an intravenous infusion over 30 minutes. For use in combination, see the Summary of Product Characteristics (SmPC) for the concomitant therapies. KEYTRUDA must not be administered as an intravenous push or bolus injection.

When administering KEYTRUDA as part of a combination with intravenous chemotherapy, KEYTRUDA should be administered first.

Treat patients until disease progression or unacceptable toxicity (and up to maximum duration of therapy if specified for an indication).

For the adjuvant treatment of melanoma or RCC, KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year. Refer to the SmPC for dosing in neoadjuvant and adjuvant treatment of locally advanced, or early stage triple-negative breast cancer at high risk of recurrence. KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued (a) For Grade 4 toxicity except for: endocrinopathies that are controlled with replacement hormones; or haematological toxicity, only in patients with cHL in which KEYTRUDA should be withheld until adverse reactions recover to Grade 0-1; (b) If corticosteroid dosing cannot be reduced to ≤10 mg prednisone or equivalent per day within 12 weeks; (c) If a treatment-related toxicity does not resolve to Grade 0 1 within 12 weeks after last dose of KEYTRUDA; (d) If any event occurs a second time at Grade ≥ 3 severity. Patients must be given the Patient Card and be informed about the risks of KEYTRUDA. Special populations Elderly: No dose adjustment necessary. Renal impairment: No dose adjustment needed for mild or moderate renal impairment. No studies in severe renal impairment. Hepatic impairment: No dose adjustment needed for mild or moderate hepatic impairment. No studies in severe hepatic impairment. Paediatric population: Safety and efficacy in children below 18 years of age not established except in paediatric patients with melanoma or cHL. CONTRAINDICATIONS Hypersensitivity to the active substance or to any excipients. PRECAUTIONS AND WARNINGS Assessment of PD-L1 status When assessing the PD-L1 status of the tumour, it is important that a well-validated and robust methodology is chosen to minimise false negative or false positive determinations. Immune-mediated adverse reactions Immu-

As monotherapy is indicated for adults with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in the following settings: •

1L treatment of metastatic colorectal cancer

•

2L treatment of unresectable or metastatic colorectal cancer after previous chemotherapy.

ne-mediated adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab. Most immune mediated adverse reactions occurring during treatment with pembrolizumab were reversible and managed with interruptions of pembrolizumab, administration of corticosteroids and/or supportive care. Immune mediated adverse reactions have also occurred after the last dose of pembrolizumab. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously.

Immune-mediated adverse reactions are immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated nephritis, immune-mediated endocrinopathies (including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism), immune-mediated skin adverse reactions (also including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)). Refer to SmPC for more information and management of immune-mediated adverse reactions. Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT): Cases of graft-versus-host-disease (GVHD) and hepatic veno-occlusive disease (VOD) have been observed in patients with classical Hodgkin lymphoma undergoing allogeneic HSCT after previous exposure to pembrolizumab. Infusion-related reactions: Grades 1, 2, 3 or 4 infusion reactions including hypersensitivity and anaphylaxis, could be seen with pembrolizumab treatment. Refer to SmPC for more information and management of infusion-related reactions. Overdose: There is no information on overdose with pembrolizumab. In case of overdose, monitor closely for signs or symptoms of adverse reactions and treat appropriately. INTERACTIONS No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. No metabolic drug drug interactions are expected. The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab. Corticosteroids can be used as premedication, when pembrolizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions. FERTILITY, PREGNANCY AND LACTATION Women of childbearing potential Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. Pregnancy No data on use in pregnant women. Do not use during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab. Breast-feeding It is unknown whether pembrolizumab is secreted in human milk. A risk to newborns/ infants cannot be excluded. Fertility No clinical data available. SIDE EFFECTS Refer to SmPC for complete information on side effects. Pembrolizumab is most commonly associated with immune-mediated adverse reactions. Most of these reactions resolved with appropriate medical treatment or withdrawal of pembrolizumab. The most serious adverse reactions were immune-mediated and infusion-related adverse reactions. When pembrolizumab is administered in combination with axitinib or lenvatinib, refer to the SmPC for axitinib or lenvatinib prior to initiation of treatment. For additional lenvatinib safety information related to advanced RCC see the SmPC for Kisplyx and for advanced EC see the SmPC for Lenvima. Monotherapy: Very Common: anaemia, hypothyroidism, decreased appetite, headache, dyspnea, cough, abdominal pain, nausea, vomiting, constipation, musculoskeletal pain, arthralgia, asthenia, oedema, pyrexia, diarrhoea, pruritus, rash, fatigue. Common: pneumonia, thrombocytopenia, neutropenia, lymphopenia, hyponatraemia, hypokalaemia, hypocalcaemia, insomnia, neuropathy peripheral, lethargy, dry eye, cardiac arrhythmia (including atrial fibrillation), hypertension, hyperthyroidism, dizziness, dysgeusia, pneumonitis, colitis, dry mouth, hepatitis, severe skin reactions, vitiligo, dry skin, eczema, alopecia, dermatitis acneiform, erythema, dermatitis, myositis, pain in extremity, arthritis, influenza like illness, chills, AST and ALT increases, increase in blood alkaline phosphatase, hypercalcaemia, blood bilirubin increased, blood creatinine increased, infusion related reaction. In combination with chemotherapy: Very Common: neutropenia, anaemia, thrombocytopenia, leukopenia, hypothyroidism, hypokalaemia, decreased appetite, insomnia, neuropathy peripheral, headache, dizziness, dyspnoea, cough, diarrhoea, nausea, vomiting, abdominal pain, constipation, alopecia, rash, pruritus, arthralgia, musculoskeletal pain, myositis, pyrexia, fatigue, asthenia, ALT increase, AST increased. Common: pneumonia, febrile neutropenia, lymphopenia, infusion related reaction, adrenal insufficiency, thyroiditis, hyperthyroidism, hyponatraemia, hypocalcaemia, lethargy, dysgeusia, dry eye, cardiac arrhythmia (including atrial fibrillation), hypertension, pneumonitis, colitis, gastritis, dry mouth, hepatitis, severe skin reactions, erythema, dry skin, dermatitis acneiform, dermatitis, eczema, pain in extremity, arthritis, acute kidney injury, oedema, influenza-like illness, chills, blood creatinine increased, blood alkaline phosphatase increased, blood bilirubin increased, hypercalcaemia. In combination with axitinib or lenvatinib: Very Common: urinary tract infection, anaemia, hypothyroidism, decreased appetite, headache, dysgeusia, hypertension, dyspnoea, cough, diarrhoea, abdominal pain, nausea, vomiting, constipation, rash, pruritus, arthralgia, musculoskeletal pain, myositis, pain in extremity, fatigue, asthenia, oedema, pyrexia, lipase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased. Common: pneumonia, neutropenia, thrombocytopenia, lymphopenia, leukopenia, infusion-related reaction, adrenal insufficiency, hyperthyroidism, thyroiditis, hyponatraemia, hypokalaemia, hypocalcaemia, insomnia, dizziness, neuropathy peripheral, lethargy, dry eye, cardiac arrhythmia (including atrial fibrillation), pneumonitis, colitis, pancreatitis, gastritis, dry mouth, hepatitis, severe skin reactions, dermatitis, dry skin, erythema, dermatitis acneiform, alopecia, arthritis, nephritis, influenza like illness, chills, amylase increased, blood bilirubin increased, blood alkaline phosphatase increased, hypercalcaemia. PACKAGE QUANTITIES KEYTRUDA 25 mg/mL: 4 mL of concentrate in a 10 mL Type I clear glass vial. Legal Category: POM. Marketing Authorisation numbers EU/1/15/1024/002 Marketing Authorisation holder Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands. Date of revision: August 2023 © 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin, D18 X5K7 or from www.medicines.ie. II133 Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie.

Adverse events should also be reported to MSD (Tel: 01-2998700) References 1. KEYTRUDA Summary of Product Characteristics, Available at www.medicines.ie.

CPS = combined positive score, 1L = first-line treatment, 2L = second-line treatment.,

Red Oak North, South County Business Park, Leopardstown, Dublin D18 X5K7, Ireland.

Date of Preparation: October 2023

In combination with chemotherapy for 1L treatment of locally advanced unresectable or metastatic oesophageal carcinomas or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 10.

GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA

IE-KEY-00794

OESOPHAGEAL CARCINOMAS

48 Research

83% of Over-65s Living with a Medical Condition Janis Morrissey, Director of Health Promotion, Information and Training, Irish Heart Foundation, Deb Mangone, Pfizer Healthcare Ireland Country Manager and Orlaith Gavan, Pfizer Healthcare Ireland Country Medical Director

New research from Pfizer Healthcare Ireland has revealed that 83% of over 65-year-olds are living with a medical condition in Ireland.

The Pfizer Health and Science Index shows that 83% of over 65-year-olds are living with at least one medical condition, while almost one in three are living with either Heart disease, COPD or Diabetes.

In the general population, a higher proportion (60%) of the public are living with an enduring or persistent medical condition. The research found that 60% of Irish adults are living with a medical condition such as arthritis or high blood pressure, with approximately six in ten (59%) of these attending a healthcare facility regularly for treatment or a check-up. Blood pressure (High or low), high cholesterol and depression & anxiety continue to be the most pervasive conditions. The research also revealed that there has been a 14% fall in participation rates in public vaccination programmes (not including the COVID-19 vaccine) in the past year.

The research, carried out by Behaviour and Attitudes, also indicates that a positive learning from the pandemic is the public’s positivity towards further utilising pharmacies for expanded healthcare services such as vaccinations. The percentage of the population endorsing utilising community pharmacies for expanded healthcare services increased from 29% in 2022 to 41% in 2023.

The research results also show that most have experienced flu at some stage while over a third (36%) have experienced it over the last two years. COVID-19 has been particularly invasive with over three in five suggesting they have had the disease over the past two-year period.

COVID related conditions such as long COVID have had a severe impact on adults’ ability to work and higher numbers (56%) are seeking private treatment for COVID-related conditions, highlighting the importance of the COVID-19 booster programme this winter.

Many feel that the lack of access to healthcare services during the pandemic has resulted in their condition deteriorating. 36% of people living with a medical condition believe that they have been negatively affected over the past couple of years due to a lack of access to healthcare professionals, with a quarter also believing that their condition has worsened due to a lack of access to diagnostics. Two in three adults who have experienced delays in accessing healthcare state that delays in access made them less likely to seek healthcare treatment.

Pfizer Healthcare Ireland called on the public at the launch of the annual Pfizer Health and Science Index to ensure that they are prepared this winter by attending appointments and availing of vaccines to minimise personal risk and to avoid putting undue pressure on the health system.

This year’s Index also asked the general public about their opinions of the Irish healthcare system.

Almost half (47%) of adults believe that health outcomes have improved over the last decade and in the event of developing a serious illness, two thirds (66%) of adults have confidence in the medical care they would receive.

Looking at how the cost-of-living crisis and its potential impact on healthcare services, household budgetary pressures has led to an increased trend of people putting off going to the doctor, with almost a quarter of adults (24%) admitting that they decided against a visit due to financial concerns.

Commenting on the 2023 Pfizer Health and Science Index findings, Deb Mangone, Pfizer Healthcare Ireland Country Manager, said, “With research showing that more than 80% of those aged 65 and older are living with an enduring or persistent medical condition, this is a key time of year for maintaining our health. There is additional pressure put on the health system during the winter, and it is imperative vulnerable and older people protect their health.

As we enter the winter period, we strongly urge the public, particularly the most vulnerable, to attend all medical appointments and take the necessary precautions to protect their health this winter.”

Janis Morrissey, Director of Health Promotion, Information and Training, Irish Heart Foundation, commented, “People continue

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

to be worried about heart disease with 45% of Irish adults indicating that they worry about developing heart disease as they age. Fortunately, up to 80% of cardiovascular disease is preventable and people can take action to do so. Taking proactive lifestyle steps such as controlling blood pressure and cholesterol levels, maintaining a healthy weight, eating a healthy diet, getting regular exercise, limiting alcohol intake, and not smoking.

These steps towards maintaining a healthy lifestyle are even more important for older people and we would strongly recommend all older people to ensure they attend all healthcare appointments and take the necessary precautions to protect their health.”

Orlaith Gavan, Pfizer Healthcare Ireland Country Medical Director said, “This year’s research shows the importance of older people taking precautions to protect their health this winter with the results indicating that 83% of over 65-year-olds are living with a medical condition. We know that over 65 years old are more likely to be negatively affected by winter respiratory illnesses and those living with a medical condition are even more vulnerable to these illnesses. We would urge those people in this vulnerable cohort to take the necessary precautions to protect against respiratory illness this winter.”

Looking at the public’s attitudes to science, over half (56%) of Irish adults believe that people leaving university with a STEM (Science, Technology, Engineering and Maths) qualification have a better chance of getting a job than those with a non-STEM qualification.

Given the significant presence of STEM multinationals in Ireland, 35% of the public believe that there are more job opportunities in these sectors in Ireland, compared to other countries. From an educational perspective, three quarters (76%) of adults would like to see more of a focus on science at primary school level. In terms of societal benefits, four in five agree scientific research has significantly improved health outcomes.

Report 49

Tackling Violence against Hospital Staff An integrated approach is needed to tackle violence toward healthcare workers Last year, a freedom of information request revealed nearly 5,800 HSE staff were physically abused while at work, while HSE data indicates an average of 16 health and social care workers are assaulted every day in hospitals and healthcare facilities in Ireland.

According to research, violence against healthcare workers has been on the rise since the Covid-19 pandemic. Frustration at long waiting times and staff shortages are often cited as factors that have contributed to the increase in hostility toward hospital workers.

Yet despite measures to intervene and prevent such abuse, healthcare staff are continuously exposed to aggressive behaviour from patients, the impacts of which are devastating. Declining mental health, increased anxiety and stress levels, injuries, increased rates of absenteeism and resignations are just some of the consequences of the ongoing abuse.

The question is ‘How’?

De-escalation As mentioned, we have seen various strategies introduced to curb the abuse of healthcare workers. De-escalation training, which instils employees with the skills to diffuse potentially violent behaviour, is offered to all staff to minimise the risk of an attack taking place.

The training covers behavioural analysis, proactive strategies and communication techniques, with the goal of enabling staff to handle challenging behaviours calmly and confidently. It is a valid and valuable approach to dealing with frustrated or hostile service users, yet it is not foolproof.

Aggressive behaviour is often unpredictable and despite the employee’s best efforts, hostility can quickly turn into physical abuse. This is particularly true of psychiatric facilities where mental health disorders can cause patients to behave aggressively without warning, and traditional de-escalation techniques cannot be applied.

Zero-tolerance Equally, healthcare settings often take a zero-tolerance approach

Written by Daniel Waring, CEO, Pinpoint

Yet despite measures to intervene and prevent such abuse, healthcare staff are continuously exposed to aggressive behaviour from patients, the impacts of which are devastating.

Declining mental health, increased anxiety and stress levels, injuries, increased rates of absenteeism and resignations are just some of the consequences of the ongoing abuse.

to violence, which class all aggressive behaviour from patients as wholly unacceptable and in doing so fosters a culture where hospital staff are supported and respected. Nonetheless, it is not without its issues – not least the difficulty of determining what aggressive behaviour in a healthcare environment really is.

Such strategies are also reactive; rather than prevent assaults from taking place, the policy poses sanctions on those who behave inappropriately. It is perhaps for

this reason that despite the NHS introducing a zero-tolerance policy in 1999, rates of abuse toward healthcare workers continue to rise and a large portion of staff deem the approach to be ineffectual at preventing attacks by patients.

Technology: Staff attack systems The limitations of these existing measures have paved the way for technology to intervene. The presence of alarm systems in healthcare settings is increasingly common, indicating the growing importance of technology to protect employees in high-risk workplaces.

Staff safety systems, such as those manufactured and installed

by Pinpoint Ltd, reduce the risk of violent attacks through a powerful, reliable security network that signals when and where a potential incident is taking place.

In practice, this means that staff faced with an aggressive patient can alert responders to their exact location and the incident level by simply pressing a button on a discreet, personal alarm. Doing so allows the response team to swiftly intervene and prevent the situation from escalating further.

Staff alarms typically have two call levels, one to indicate assistance is needed (where a patient is behaving in a hostile way) and another for emergency, which signals violent behaviour is taking place. In both situations,

colleagues will attend the scene to provide support and prevent the risk of harm to staff members.

The number of assaults that take place in a healthcare setting typically decreases following the installation of a safety system, as residents realise employees have access to immediate help.

In this way, alarms are both a preventative and reactive measure to minimise aggression from patients and reassure employees of their safety at work.

Conclusion As more instances of abuse and violence by patients are reported, it is clear that more needs to be done to protect our dedicated healthcare workers.

It is only by integrating all three strategies outlined above that healthcare settings can begin to develop a truly complete, robust approach to tackling the rising abuse of healthcare staff.

Used in conjunction with one another, modern alarm systems, de-escalation training and a zero-tolerance approach serve to effectively reduce the abuse of healthcare workers. In doing so, staff gain confidence in their safety while at work, increasing workplace morale, reducing rates of absenteeism and ultimately improving the quality of care delivered to patients.

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

50 Glaucoma

Recent advances in glaucoma management provide hope to thousands of sufferers Written by Mr Pavi Agrawal, Consultant Ophthalmologist Specialising in Cataract and Glaucoma, Mater Private Hospital Dublin www.dublineyesurgeon.ie

Glaucoma is the most common cause of irreversible blindness worldwide. Open-angle glaucoma (OAG) is the most frequent phenotype, with a prevalence of 2% in people over the age of 40 years. The Irish College of Ophthalmologists have also identified glaucoma as the leading cause of blindness in Ireland, with the incidence expected to rise by 33% over the next 10 years. Almost half of all cases remain undiagnosed, as patients are often asymptomatic until much later in the disease course.

This makes early detection and treatment imperative to a good visual prognosis. Glaucoma is characterised by progressive loss of retinal ganglion cell (RGCs) and optic nerve damage, often associated with elevated intraocular pressure (IOP). As a result, patients begin to lose their peripheral vision, and as the disease progresses their central vision can begin to be impacted; eventually leading to total loss of sight.

bridging the gap between medical therapies and more traditional surgical interventions including trabeculectomy and aqueousshunt surgery. As a result, there has been a monumental shift in the glaucoma treatment paradigm from ‘drops for life and surgery as a last resort’ to ‘earlier intervention in order to preserve vision.’ Whilst trabeculectomy and aqueous-shunt surgery remain highly effective at lowering IOP, they come with higher complication risks including bleb infection, post-operative manipulation, revision surgery and hypotony. On the other hand, topical medications may not be effective enough at lowering the IOP, and their chronic use may give arise to non-compliance as well as aggravate ocular surface disease, thus exacerbating the very problem they were designed to address. The advent of laserbased glaucoma interventions as well as minimally invasive glaucoma surgery (MIGS) enables glaucoma specialists to narrow the gap between traditional treatment techniques.

Selective laser trabeculoplasty (SLT) was first introduced in 1995 and received US FDA clearance in 2001. It has been shown to reduce IOP by inducing a mild sub-clinical inflammatory reaction to the trabecular meshwork (internal drainage system of the eye), enhancing aqueous outflow,

and is performed as a single, painless outpatient procedure with a short recovery time and a good safety profile. In 2019, the landmark Laser in Glaucoma and ocular HyperTension (LiGHT) RCT study was published. In this work, treatment naïve patients with ocular hypertension and open angle glaucoma were randomly assigned to topical anti-glaucoma medication vs SLT as their first-line treatment. At 36 months, 75% of the patients in the SLT group required no drops to maintain target IOP. The SLT group had overall better IOP control with a greater preservation of visual fields. First-line SLT at diagnosis has now been recommended as the preferred treatment by the UK National Institute of Care Excellence (NICE), and as an equivalent alternative to topical medication in the latest European Glaucoma Society Treatment Guidelines. If initially ineffective, SLT can be repeated, reducing the reliance on topical medications and the side-effects that can be associated with their use.

Minimally Invasive Glaucoma Surgery (MIGS) procedures are a heterogenous group of implants, devices and surgical techniques that tend to be simpler, safer and quicker to perform, albeit with a lower drop in IOP compared trabeculectomy and aqueousshunt surgery. They are therefore more suitable for mild-to-moderate glaucoma patients and can be performed in conjunction with cataract surgery or alone. There is increasing published outcome data supporting MIGS in lowering IOP and reducing the need for topical medication, improving the ocular surface, enhancing patient’s quality of life as well as reducing the rate of visual field progression

Over the past two decades there has been a proliferation of glaucoma treatments, with laser and minimally-invasive options

Insertion of OMNI® Surgical System cannula through ~2 mm clear corneal incision (left); accessing Schlemm’s canal and insertion of the microcatheter (middle); withdrawing the cannula to perform trabeculotomy (right) DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

and delaying the need for more invasive filtration surgery.

The mechanisms by which MIGS lower IOP include: trabecular bypass stents into Schlemm’s canal, overriding the resistance at the level of the trabecular meshwork (iStent, Glaukos California, USA and Hydrus, Alcon – Geneva, Switzerland), increasing uveoscleral outflow via drainage into the suprachoroidal space (Miniject, iStar Medical - Waver, Belgium and iStent Supra Glaukos - California, USA), visco-dissection of Schlemm’s canal and the outflow channels (OMNI device, Sight Sciences – California, USA and iTrack Advance, Nova Eye MedicalAdelaide, Australia) and excision of the trabecular meshwork (Kahook Dual Blade, New Medical World – California, USA and Sion, Sight Sciences – California, USA). Each MIGS procedure has its own place, with the choice of which MIGS to perform based on several factors including: surgeon experience, the type of glaucoma, the severity of glaucoma and rate of progression, medication burden, the target IOP as well as the presence of cataract.

With the advent of selective laser trabeculoplasty and minimally invasive glaucoma surgery, glaucoma specialists are equipped with a greater armetarium of IOP lowering treatments. This will allow patients a greater choice in their management, minimising the long-term use of topical medication. It is an exciting time to be a glaucoma surgeon and I personally have seen some very successful outcomes from the use of these newer treatments, which ultimately have led to significant improvements in my patient’s outcomes and their quality of life.

News 51

Calls for National Osteoporosis Programme An international research team has revealed that between 300,000 and 500,000 men and women in Ireland are living with osteoporosis.

• More than 1 million people in Ireland have low bone mineral density putting them at greater risk of fracture.

The findings were released by University of Galway to coincide with World Osteoporosis Day held recently on Friday October 20th.

• Although men have a lower risk of fracture, they account for almost 1 in 3 public hospital admissions for osteoporotic fractures in Ireland.

Although the burden of illness related to osteoporosis - morbidity, mortality and economic costs - is similar to cardiovascular disease and cancer, the importance of osteoporosis is often not understood, and therefore care is neglected.

Researchers from the schools of Engineering, Computer Science and Medicine at the University of Galway carried out their analysis in collaboration with Tsinghua University in China, Oxford University in England, and Galway, Manorhamilton and Sligo University Hospitals.

The research used data from the health service in Ireland spanning 20 years to reveal: • More than 50,000 osteoporotic fractures occur each year in Ireland.

• 1 in 3 men and 1 in 5 women die within 1 year following a hip fracture.

• The number of osteoporosisrelated deaths in Ireland is similar to, or greater than, the number of deaths related to Covid-19.

• Fewer than one fifth of people admitted to public hospitals with an osteoporotic fracture are discharged with a diagnosis of, or treatment for, osteoporosis.

Professor John Carey is Professor in Medicine at University of Galway and Consultant Physician in Medicine and Rheumatology

• Less than 50% of older people who suffer an osteoporotic hip fracture will return to their baseline level of function.

could reduce the number of unnecessary requests for a DXA test and increase referrals for those in need.

• Fractures are one of the leading causes of long-term admissions to nursing homes.

Early data suggests the financial cost of poor quality DXA scans in Ireland may be greater than the cost of providing high quality DXA which adheres to national and international standards, in particular avoiding testing and treating those at low risk and improving diagnosis and management of those with prior fractures.

The research team noted that public hospital bed days for fragility fractures among adults aged over 50 have risen almost 50% since 2008 and are at a higher level than those for ischemic heart disease, solid cancers, or diabetes mellitus - conditions where national programmes exist.

Clinicians, computer scientists and engineers at University of Galway are using Dual-energy X-ray Absorptiometry (DXA) technology to measure bone density and develop new screening and testing strategies for early identification of osteoporosis.

Funded by the Health Research Board, the Dual-energy X-ray Absorptiometry Management Application Project (DXA MAP) uses state of the art machines to develop a personalised, patientcentred tool for osteoporosis screening and fracture prediction.

The international research team said novel osteoporosis-screening

Professor Carey is Professor in Medicine at University of Galway and Consultant Physician in Medicine and Rheumatology and Clinical lead in DXA, Osteoporosis and Fracture Liaison Services, Galway University Hospitals.

“The key to prevention is the early detection of those most at risk.

But what we require is a better use of current resources to benefit those at greatest risk, preventing more fractures, and eventually lead to substantial cost savings,” Professor Carey said.

“DXA is the clinical test used to diagnose osteoporosis before a fracture occurs, as well as to estimate fracture risk and to monitor the effects of treatment.

Access to quality DXA is a global problem, and Ireland is no different.

“Although Ireland has one of the highest rates of osteoporotic fracture and will have the one of the greatest increases in cost and incidence over the coming decade, it does not have a national programme or consider osteoporosis a national priority.

It is very clear to those of us who lead treatment and research of the disease that we should. A national programme could greatly focus efforts to enhance current care and further improvements can be made without additional funding.”

The research team validated the Osteoporosis Self-assessment Tool Index (OSTi) - one of the oldest and simplest methods for the identification of those at risk of osteoporosis - for the Irish population. They then compared it with new modelling, using artificial intelligence, which outperformed OSTi.

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

52 2023 YEAR END REVIEW JANUARY  Europe could lose out to the US and Asia for new investments in biopharmaceutical research and production, according to a new study by consultants Charles River Associates (CRA) which urges more collaboration between industry and policy leaders to boost competitiveness  The NCHD Committee of the Irish Medical Organisation (IMO) balloted NCHD members to seek support for an agreement with the HSE and the Department of Health on eliminating unsafe and illegal hours. The agreement would see employers being penalised for noncompliance  The National Cancer Registry (NCRI) published its 2022 Annual Statistical Report: Cancer in Ireland. 1994 – 2020. Key findings included an increase of over 50% in numbers of cancer survivors compared to a decade ago, further evidence of improvements in colorectal cancer control in men and lung cancer as the leading cause of cancer death  University Hospital Galway welcomed world pioneering surgeons, Professor Diego González Rivas to the hospital. During his visit Professor González Rivas, delivered a lecture to colleagues across the Department of Cardiothoracic Surgery entitled “The Journey of Uniportal Thoracic Surgery from VATS to Robotics”  Medicines for Ireland urged to Government to heed warnings from GPs and pharmacists on the growing risk of medicine shortages

FEBRUARY  The Department of Health and HSE issued circulars confirming the implementation of a revised pay scale and revised management posts for hospital pharmacists, agreed with Fórsa and the HPAI following the Building Momentum review in 2022  HIV Ireland called for increased investment in nationwide sexual health services to ensure Ireland can meet its global commitment to end new HIV transmissions. Statistics published by the Health Protection Surveillance Centre indicate that more 750 cases of HIV have been notified in 2022, more than double the number for the same period in 2021  The Medicines Shortage Index, prepared by Azure Pharmaceuticals, found that there are 224 medicines currently unavailable, an increase of 12 medicines in seven days as the crisis continued  Professor Eddie Moloney and Cono Hayes authored an article detailing the Top 5 Respiratory Conditions placing the biggest burden on Irish health care including COPD, Asthma, Lung Cancer, Obstructive Sleep Apnoea and Pneumonia  Professor Jarushka Naidoo was appointed as Academic Professor of Medical Oncology in the RCSI Department of Medicine. Professor Naidoo will lead RCSI’s innovative medical cancer research team to further its growth and development, and continue its work to secure funding for vital international cancer research

MARCH  The Memorandum of Understanding was renewed between Beacon Hospital’s Pharmacy Department and RCSI School of Pharmacy and Biomolecular Sciences. Through collaboration and cooperation, Beacon Hospital and RCSI are mutually committed to the on-going development, delivery and promotion of a person-centred model of care for Pharmacy Practice in accordance with international best practice  The European Union awarded a European consortium ¤4.4million for the SMARTSHAPE project to focus on developing an implantable medical device for continuous blood pressure monitoring. The SMARTSHAPE consortium is led by Professor William Wijns  The first in-person conference to focus on ‘The vision for a comprehensive stroke care pathway in Ireland’ was hosted by the iPASTAR (Improving Pathways for Acute Stroke and Rehabilitation) programme at the RCSI Education and Research Centre, Beaumont Hospital

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

2023 YEAR END REVIEW 53 APRIL  On International Women’s Day, the President of the Medical Council, Dr Suzanne Crowe called for increased equity in the medical profession.  Doctors in the Irish Medical Organisation (IMO) voted to reject a new contract for hospital consultants with a salary of up to ¤257,193 which came into force in March.  Experts at an international conference on nutrition said lives are being lost – and called out the Government on the lack of a specialist service for Intestinal Failure. Speakers at the conference on nutrition and health in Dublin, hosted by the Irish Society for Clinical Nutrition and Metabolism (IrSPEN), said the situation was a ‘national disgrace’  A new report for the World Health Organisation identified five core national targets for UN member states aimed at reducing diabetes risk and ensuring that people with diabetes have equitable access to comprehensive and affordable care and prevention. The lead author on the report for WHO Global Diabetes Compact was Professor Edward Gregg, Head of RCSI’s School of Population Health

MAY  A report highlights the priorities and needs of patients affected by neurological disease, as well as clinicians and researchers, to inform the implementation of the HSE’s National Strategy for Accelerating Genetic and Genomic Medicine in Ireland  The Irish Medical Organisation (IMO) has criticised the new consultant contract being introduced by Government. Professor Matthew Sadlier, Chairman of the Consultant Committee of the IMO said that the Government has missed an opportunity to create an attractive common contract that would appeal to all consultants (existing and new)  The Private Hospitals Association (PHA) announced it is to extend its remit to become a cross-border representative organisation for the independently funded hospital sector throughout the island of Ireland.  Dr Roisin McAvera and Professor Siobhan Glavey author a Continuing Professional Development module on Multiple Myeloma: Disease Overview and the Role of Genomics

JUNE  The Irish Cancer Society announced a new partnership with Trinity College Dublin and St James’s Hospital designed to develop an outstanding programme of cancer treatment and care for patients in Ireland. The five-year collaboration will see the Society invest ¤4.5million in several specific exemplar programmes aimed at delivering a new model of cancer care for patients in Ireland  Ireland is once again one of the slowest countries in Western Europe to reimburse and make available new innovative medicines to patients, according to figures gathered by data analysts IQVIA for EFPIA, the European pharmaceutical industry body  Professor Graeme Clark AC – pioneer of the bionic ear, or multi-channel cochlear implant – was awarded an Honorary Fellowship of the Royal College of Surgeons in Ireland (RCSI)  The frequency of diabetes during pregnancy is rising in women with HIV in Ireland and the UK, in line with trends in the rest of the population, Laurette Bukasa of University College London reported at the British HIV Association conference  Ahead of World IBD Day Crohn’s and Colitis Ireland launched a new Symptom Checker. The tool forms part of its “Poo Taboo” campaign which aims to lift the lid on some of the stigma around IBD symptoms and the importance of people not being too shy to get checked out

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

54 2023 YEAR END REVIEW JULY  University of Galway welcomed Government approval for three new healthcare degrees. The three new healthcare degree programmes for University of Galway - Pharmacy, Graduate Entry Medicine, and Graduate Entry Nursing - are in direct response to the needs of the healthcare sector and demand for staff, particularly in rural areas  The Pharmaceutical Society of Ireland published its annual report for 2022, outlining the significant work undertaken by the regulatory authority to protect the health, safety and wellbeing of patients and the public by regulating pharmacists and pharmacies in Ireland  Heart & Stroke Voice Ireland (HSVI), a newly launched patient and carer led alliance, addresses the unmet needs of patient centred care by championing patient engagement and involvement. The alliance, which operates under the auspices of Croí, the heart and stroke charity, called for a ‘Patient First’ national cardiovascular disease (CVD) strategy, that is shaped by the lived experience of those living with CVD in Ireland. The alliance is the first of its kind in Ireland

AUGUST  The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency issued recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections for European patients in the next winter season  A new National Clinical Guideline for treatment of patients with breast cancer was published by the HSE National Cancer Control Programme (NCCP)  Cancer Trials Ireland announced details of a new research survey of women with breast cancer whose cancer has spread, also known as secondary or metastatic breast cancer. The survey – Ireland’s first-ever patient-led research to undergo rigorous ethics and scientific approval – is being spearheaded

by Siobhan Gaynor  Dr Ray McDermott authored an article entitled ‘Oncotherapeutic Strategies in Early Onset Colorectal Cancer as part of our Peer Review Special Focus  The School of Medicine, Trinity College and Head of School Professor Colin Doherty celebrated the Schools’ female full professors and marked the appointment of the first ever female Regius Professorship of Physic (1637) at Trinity College Dublin, Regius Professor Rose Anne Kenny

SEPTEMBER  Wing and Apian partnered to begin medical drone delivery services in Ireland and jointly explore opportunities in the UK. They are to begin working with healthcare and pharmacy partners to create a rapid medical delivery network in South Dublin  A team led by Consultant Urologist Professor Rustom Manecksha carried out a new type of minimally invasive procedure treating BPH in the Reeves Day Surgery Centre at Tallaght University Hospital  Bon Secours Health System (BSHS) has launched a groundbreaking ¤25 million clinical transformation project with healthtech firm MEDITECH which is to connect its entire hospital network using one electronic healthcare record (EHR)  In a discovery that could lead to new treatments for epilepsy, a study led by RCSI University of Medicine and Health Sciences and FutureNeuro has identified a previously unknown ‘master controller’ of electrical signals in brain cells  This year's General Assembly of the European Association of Hospital Pharmacists (EAHP) adopted a new Position Paper on Infectious Diseases and Antimicrobial Resistance

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

2023 YEAR END REVIEW 55 OCTOBER  University College Cork researchers were awarded £2.7m by the European Research Council to lead major studies on gut bacteria and the post-war history both of colonialism and of veterancy around the world  Dr Frank Moriarty, Senior Lecturer at RCSI School of Pharmacy and Biomolecular Sciences, received a £2.4m Career Development Award from Wellcome to advance new methods to research deprescribing – the planned process of reducing or stopping medicines that may no longer be of benefit  The European Society of Cardiology published new cardiology Guidelines on Acute Coronary Syndromes with the expert taskforce delivering them being led by Irish Heart Health expert, Professor Robert Byrne

NOVEMBER  The first report of its kind in Ireland examining the emerging risks to the future availability of pharmacists in patient-facing settings was launched in the Department of Health by Secretary General Robert Watt. The Workforce Intelligence Report* commissioned by the PSI -the Pharmacy Regulator, examines the current challenges to the recruitment and retention of pharmacists in community and hospital settings  The Asthma Society of Ireland, now in its 50th year of impact, released its 2024 pre-budget submission, with seven budgetary asks focused on preventing asthma deaths in Ireland, improving the quality of life for 380,000 people in Ireland with asthma, and reducing the cost of asthma to both the State and the individual  Three in five doctors (60%) have experienced or witnessed verbal or physical abuse from patients or their relatives within the past 12 months, with 37% saying the incidents resulted from staff shortages and 39% saying it was due to the referral waiting list, according to the results of a Medical Protection Society (MPS) survey  More than 850 students took part in White Coat Ceremonies at RCSI University of Medicine and Health Sciences  Dr Sally Griffiths and Dr David Breen authored an article looking at Smoking Cessation: An Essential but Under-utilised Pillar of Irish Healthcare

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

Professional Top 100 2016, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News,

Hospital Professional

As we look ahead into 2024, now is the time to reflect on those who have been, and who will be, empowering others moving into the future.

We’re marking the end of 2023 with our unique HPN Professional Top 100 – a prestigious annual list which celebrates Ireland’s top hospital and healthcare achievers.

The HPN Top Professional Top 100 is a carefully constructed network of the most influential hospital professionals across a range of disciplines, both in the healthcare and pharma industries, who act as ambassadors and role models for their peers and colleagues.

Over the past many months, our team of writers has reached out to pharmacists, consultants, clinical specialists, representative bodies and organisations throughout the sector and encouraged them to put forward those colleagues they feel are redrawing the landscape for the future.

Those who have made our final list have displayed motivating behaviour and inspirational leadership affecting the development of hospital services across Ireland.

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

Professional Top 100 2016, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News, Professional Top 100, Hospital Professional Awards, Professional Top 100, Hospital Professional News,

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

Professional 100 Dr Scheryll Alken, Consultant Medical Oncologist, Adolescent & Young Adult Oncology, Children’s Health Ireland at Crumlin/St James’s Hospital Dr Alken is Ireland’s first dedicated Adolescent & Young Adult (AYA) Cancer focused Consultant Medical Oncologist, and the first clinician appointed to focus solely on AYA cancer in Ireland.

Since her appointment in 2021, she has endeavoured to progress the care of AYAs with cancer working with a dedicated team of healthcare professionals. A key member of the Children, Adolescent & Young Adult Clinical Leads Group at the NCCP, she was instrumental in the development of the Framework for the Care and Support of Adolescents & Young Adults with Cancer, published in 2021. This lead to the development of a national AYA Cancer Services Network, working to develop equitable, age & developmentally appropriate care for young people with cancer.

Scheryll is a strong advocate of the patient voice, and centering young people in any service development or research project. A believer in equity in healthcare, she is joint holder of a grant from the Irish Cancer Society, along with Prof Suzie Guerin in UCD, exploring the experiences of marginalised communities within the AYA Cancer population, seeking to identify barriers to care and healthcare engagement.

Clinically, Scheryll co-founded AYA Cancer Ireland, a special interest group for healthcare professionals caring for young people with cancer across Ireland. With colleagues at St James’s, she developed “The Hangout”, a non-clinical monthly event, focused on maximising the potential of young people following a cancer diagnosis, utilising an innovative partnership with the Guinness Enterprise Centre.

Mr Fabio Bartolozzi, Consultant Cardiothoracic Surgeon, University Hospital Galway/Senior Lecturer, Royal College of Surgeons in Ireland Mr Bartolozzi led the surgical team at University Hospital Galway who recently became the first hospital team to introduce a new minimally invasive surgery for coronary artery bypass grafting. The endoscopic radial harvest programme reduces significantly the risk of complications and infection for the patient.

Mr Bartolozzi was the only Surgeon in Ireland to perform a cardiothoracic surgery procedure using the da Vinci robotic system. The surgeon - who has spent the past 25 years working in Irish hospitals, including the Mater, St James’ and the Blackrock Clinic before moving to Galway in 2004 to set up the west of Ireland’s first cardiothoracic surgery department at the Galway Clinic - carried out his groundbreaking first Irish robotic thoracic procedure late last month. This followed intense training in France and Germany.

Ashley Bazin, Team Leader, Oncology & Haematology Clinical Trials Unit, Tallaght University Hospital Earlier this year, Ashley was awarded the Irish Cancer Society Support Staff of the Year Award for 2023, in recognition of her contribution to driving forward Clinical Trials in TUH. Ashley is an experienced research nurse and has been the Team Leader of the Oncology and Haematology Clinical Trials Unit at Tallaght University Hospital for over 16 years. Ashley says her main focus is “on ensuring patients have access to the best treatment options as well as engaging with Cancer Trials Ireland and pharmaceutical companies to bring promising new treatments to patients.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Dr Nollaig Bourke, Ussher Assistant Professor, Trinity College Dublin/Adjunct Research Fellow, Hudson institute of Medical Research/Monagh University During 2023, Dr Bourke co-led research that discovered the anti-tumour activities of the immune protein interferon epsilon, which in pre-clinical models blocks the metastasis of ovarian cancer cells by instructing immune cells to kill the cancer cells.

The search for preventions and cures for the most prevalent and deadly form of ovarian cancer has now turned inward with the discovery of the anti-tumour activities of an immune protein called ‘interferon epsilon’. Her research was published in the journal Nature. Dr Bourke’s research has a strong translational focus and along with her work in TILDA, her research lab is located in the Trinity Translational Medicine Institute (TTMI) in the St. James’s Hospital precinct. Here, her team focus on investigating innate immune signalling pathways, particularly type I interferon and inflammasome signalling, that result in pathological inflammation and decreased immunity in older adults. She collaborates with many clinical and scientific colleagues and her lab is now exploring these mechanisms across specific disease states associated with accelerated ageing and/or pathological inflammation e.g. HIV, ANCA-associated vasculitis, type II diabetes and cancer.

Professor David Brayden, Advanced Drug Delivery, School of Veterinary Medicine/Fellow, UCD Conway Institute Professor Brayden and his team have been awarded just under ¤3.8 million by the EU’s Horizon Europe RESILIENCE programme towards a project to develop a patch worn on the cheek that delivers peptide* treatments for Type 2 Diabetes.

The ‘BUCCAL-PEP’ project will combine skills to develop a multifunctional biomaterial patch which allows, for the first time ever, delivery of peptide therapies across the cheek (buccal).

Existing patches have already been designed for small molecules but these cannot effectively deliver peptide treatments by this route of administration. Type 2 Diabetes patients need the peptide insulin to treat the disease.

Ciara Breen, HSCP Lead, National Clinical Programme for Stroke Ciara and her team won a nation award during this year for their group patient support programme developed by team members from the Long COVID and post COVID clinics in Galway University Hospitals.

The programme covers a range of areas including fatigue management, brain fog, sleep restructuring, post-exertional malaise, pacing, breathing pattern changes and relaxation. 70% of the group participants identified work as a key area of concern, with household tasks, parenting, self-care and leisure activities also being common problems among many. A problem solving approach is taken, enabling each person to apply the knowledge in a way that is unique to their symptom profile and personal circumstances.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Professor Donal Brennan, School of Medicine, University College Dublin /National Clinical Lead for Cancer Research As National Clinical lead for Cancer Research in the National Cancer Control Programme, Professor Brennan helped shape the development of a National Cancer Mission Hub. With the NCCP team and the All-Island Cancer Research Institute Professor Brennan was one of the keynote speakers during EU Cancer Mission Day, which explored innovative approaches, knowledge and experience of cancer.

He has over 60 peer-reviewed publications and has been named on 6 international patent applications and is currently a PI in the Cancer Biology and Therapeutics Laboratory, Systems Biology Ireland and UCD Diabetes Complications Centre.

Orla Brett, Physician Associate, Beaumont Hospital Since graduating as a Physician Associate, she has been an advocate for the profession and has always been willing to mentor and teach upcoming students, both in the classroom and in clinical practice. Each year, since graduation, Orla has provided practice sessions for Physician Associate students in advance of their final exams and feedback on these sessions has been very positive. In short, she has been a role model for the profession. She has been one of the early members of the Irish Society of Physician Associate (ISPA) board, giving her time to promote the profession nationally and globally. She has been actively involved in organising the inaugural conference of Physician Associates, which took place in October of this year. She has been voted in by her peers this year as Vice-President of the ISPA. Orla has been a core member of her multidisciplinary team at Beaumont Hospital, ensuring continuity of care for patients. She has upskilled herself by carry out courses in Robotic surgery, to work alongside her supervising consultant, Mr William Robb.

Professor Annette Byrne PhD, Professor of Physiology/ Head, RCSI Precision Cancer Medicine Group/Founder, Director, National Pre-clinical Imaging Centre Professor Byrne is regarded as one of the most prominent and successful active pre-clinical cancer researchers in Ireland. Her research is largely dedicated to the discovery of novel treatments to improve brain and colorectal patient outcomes, with a particular emphasis on disease indications where currently available therapies remain insufficient. She has won > ¤45 million in national and international funding as Lead or Co-Investigator. This funding has supported several seminal and ground-breaking discoveries in the oncology field. Over the years Prof Byrne has delivered an impressive research output documented by senior author contributions to original manuscripts published in the leading journals: Cancer Discovery, Annals of Oncology, Journal of Clinical Oncology as well as several Nature journals (including Nature Genetics and Nature Communications).

Notably, Prof Byrne has received > ¤6M Euro in EU funding for two prestigious Marie Curie European PhD training networks (GLIOTRAIN & GLIORESOLVE) with the former acknowledged by the EC as one of the best conceived and organized European Training Networks in the European Union.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Dr Rachel Byrne, School of Medicine, University College Dublin Dr Byrne is one of the members of an early-stage Medtech start-up, which is focused on transforming obesity care. They recently won the University College Dublin Start-Up of the Year Award.

MetHealth received the award, and its ¤30,000 prize fund, after being declared the overall winner of the 2022 UCD VentureLaunch Accelerator Programme – which aims to equip its participants with the knowledge and skills required to work as part of a team leading a new commercial venture. The company is developing a biomarker-based risk-stratification platform and associated digital health solution that can identify patients with complications of obesity, including liver disease.

Professor Robert Byrne, Chair of Cardiovascular Research, RCSI School of Pharmacy and Biomolecular Sciences/Director of Cardiology, Mater Private Hospital Professor Byrne chaired the European Society of Cardiology Taskforce who published new guidelines on acute coronary syndromes. The guidelines provide detailed advice on treatment, which includes medications such as blood thinners.

Professor Byrne has held several strategic positions at German Heart Centre, including Consultant Cardiologist and Deputy Director of Cardiology.

Shane Byrne, National Clinical Lead/Chief Pharmacist, National Medicinal Product Catalogue, HSE Shane’s role is as clinical lead and chief pharmacist for the National Medicinal Product Catalogue (NMPC) where he is leading its establishment. The NMPC will enhance patient safety by standardising and enhancing the availability of medicines information across a patient’s journey.

Across 2023 Shane chaired the national Covid-19 Medicines Management Subgroup. This group supported the HSE centralised vaccination centres by leading on the development of national guidance and operating procedures for the safe and effective use of vaccines. In 2023 the CVCs saw the first use of paediatric vaccines (5-11 years and 6 month-4 years), continued expansion of adapted booster vaccines in adult cohorts, and supported other vaccination campaigns including the catch-up vaccination programme for Beneficiaries of Temporary Protection (BOTP) and the Laura Brennan HPV vaccination catch-up programme.

As the COVID-19 programme changed from centralised vaccination centres to focus on high-risk patient groups in the community Shane led the establishment of a long term, multi-disciplinary vaccine stewardship oversight group for the new vaccination programme.

Professor Michelle Canavan, Consultant Physician in Geriatric Medicine, Saolta University Health Care Group Professor Canavan is currently working on increasing access to clinical trials for older people to have targeted healthcare solutions which help maintain their independence as they get older. Professor Canavan believes that involvement in clinical trials, which informs evidence-based care, improves the standard of care for everyone in the region. “Multidisciplinary care is the cornerstone of geriatric medicine and therefore, research in this area involves doctors, nurses, carers and health and social care professionals (physiotherapists, speech and language therapists, social workers, among others) working with the older person themselves,” she says.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Professor Noel Caplice, Professor of Cardiovascular Sciences, Department of Medicine/Director, Centre for Research in Vascular Biology, University College Cork A tourist recently returned to Ireland to thank Professor Caplice for saving his life during a severe heart attack. The patient is now on the road to recovery, but living with a heart function rate of just 27%. A three-week stint in CUH’s coronary care unit was followed by the fitting of an ICD (defibrillator) and pacemaker at Spire Hospital in Manchester and further care at Liverpool Heart and Chest Hospital. Last month, Mark and Julie returned to Cork to present CUH Charity (the hospital’s fundraising arm) with a donation from players at Ormskirk Rugby Club.

Professor Caplice currently directs the CRVB at UCC and his research programme is funded by the NIH, Science Foundation Ireland (SFI) - PI grant, and Health Research Board (HRB) - Translational research.

Dr Philip Cardiff, Associate Professor, University College Cork A UCD project aiming to use pioneering computational techniques that could make pig-to-human heart transplants a reality has received a European Research Council (ERC) Consolidator grant of ¤2 million.

With this support Dr Cardiff hopes to establish a new field of ‘computational cardiac xenotransplantation’. His five 5-year project 'XenoSim' will develop advanced computational techniques that can provide unprecedented insights into the cuttingedge realm of pig-to-human heart transplants.

Mr Paul Carroll, Consultant Oesophagogastric/ General Surgeon, Galway University Hospital Mr Carroll caried out a procedure this year which saw Galway University Hospitals (GUH) becoming the first hospital in Ireland to introduce an ‘incisionless’ minimally invasive surgery to help correct blockages of the oesophagus.

Achalasia is a rare condition which causes a blockage in the muscles of the lower oesophagus causing dysphagia or difficulty in swallowing, including in pronounced cases, liquids.

The procedure was carried out by Mr Carroll, Consultant Oesophagogastric and General Surgeon, specialising in minimally invasive surgery and endoscopic surgery for oesophago-gastric cancer and benign disease.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Dr Dearbhaile Collins, Consultant Medical Oncologist, Cork University Hospital Dr Collins is presently the Clinical Lead of the Medical Oncology Department at CUH. She has a subspecialty interest in gynaecological and thoracic cancers as well as translational research and early phase trials.

She is the President of the Irish Society of Gynaecological Oncology (ISGO), the Cancer Trials Ireland (CTI) Gynaecological cancer clinical trials co-chair and the CTI representative at European Network of Gynaecological Oncology Trials (ENGOT). She was also the CTI representative at the ENGOT Gynaecological Cancer Academy from 2019 to 2021. She is the Irish Principal Investigator (PI) of a number of past and ongoing international clinical trials in ovarian, endometrial and cervical cancer. She is also a member of a number of international Scientific Advisory Committees of gynaecological cancer clinical trials and has been invited on many international expert consensus groups in this cancer subtype.

Her translational research has led to being awarded the Irish Cancer Society Clinician Research Leadership Award 2020. She is also a co-founder of the Women 4 Oncology Ireland and involved in a national benchmarking study of wellbeing, burnout and gender challenges among doctors involved in cancer care.

Professor Roisin Connolly, Professor Gerald O’Sullivan Chair in Cancer Research, University College Cork Professor Connolly has led numerous multi-centre clinical trials in collaboration with the Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute (NCI), the Translational Breast Cancer Research Consortium (TBCRC), and the Eastern Co-operative Oncology Group (ECOG)ACRIN in the US. Professor Connolly is Study Chair for the international phase III ECOG-ACRIN study (E2112) investigating the epigenetic agent entinostat in combination with hormonal therapy in patients with metastatic breast cancer. She recently received the prestigious ECOG-ACRIN Young Investigator Award 2019 for excellence in clinical investigation.

Roisin is Director of Cancer Research @UCC and a Principal Investigator with Cancer Trials Cork at CUH. She recently received an Irish Cancer Society grant to support a Women’s Cancer Survivorship Clinic in Cork, which she is leading with Professor Josephine Hegarty (School of Nursing) and multiple collaborators across the region.

Dr Kate Connor, Research Fellow, Trinity College Dublin/Precision Cancer Medicine Group, Royal College of Surgeons in Ireland Dr Connor is leading research which has discovered three new subtypes of glioblastoma brain tumour which, with further investigation, could offer new hope in the form of much-needed effective therapies and improved outcomes for patients. This discovery is particularly impactful because currently, most patients with glioblastoma are treated in the same way. Further investigation of these newly identified subtypes will mean that different patients could receive treatment specific to the cells in their own tumour, a concept known as 'precision medicine'.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Professor Richard Costello, Consultant Physician, Beaumont Hospital/Professor of Medicine, Royal College of Surgeons in Ireland Professor Costello is Lead Investigator of an international study which has revealed significant potential for digital technology to improve asthma control for patients.

The Inhaler Adherence in Severe Unstable Asthma (INCA-SUn) study examined the effectiveness of combining information from digital device in a digital platform to effectively manage uncontrolled asthma.

The findings, which on average led to a healthcare cost reduction of ¤3,000 per patient, demonstrate the future potential of digital medicine in the management of many chronic diseases.

Professor Annie Curtis, Professor of Immunology, Royal College of Surgeons in Ireland Due to funding awarded to Professor Curtis by the Science Foundation Ireland Career Development Award (CDA) programme and by the Irish Research Council through a Laureate Award, a new study is heralding great success.

Researchers led by Professor Curtis at RCSI University of Medicine and Health Sciences have discovered how disruption of the circadian clock can lead to increased inflammation in the lungs, which may have negative effects on chronic lung diseases and respiratory infections.

The paper looked at the molecular clock in fibroblasts, a cell type which is abundant in the lung. When the regular rhythm of the fibroblast clock was lost, it resulted in an increased inflammatory response and therefore, worse symptoms.

This could have implications for individuals such as shift workers or people with erratic sleeping/eating patterns in that they are more likely to experience more severe respiratory infections.

Dr Kieran Dalton, Lecturer in Clinical Pharmacy, School of Pharmacy, University College Cork In 2023, Dr Dalton was awarded a place on the US Deprescribing Research Network’s (USDeN) Junior Investigator Intensive program. Kieran is also actively involved in several other research areas of patient-focused research, with collaborators locally, nationally, and internationally.

As part of his current role, Kieran is involved in teaching undergraduate and postgraduate students in the BPharm/MPharm, MSc Clinical Pharmacy degree, and the Certificate in Nurse Prescribing in UCC. He also teaches undergraduate pharmacy students from Future University in Egypt – which is an affiliated institution of UCC. Kieran has published a wide variety of research with students at undergraduate and postgraduate levels. He is currently supervising three PhD students, and has supervised 12 MSc Clinical Pharmacy students to completion.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Dr Michael Daly, Honorary Clinical Lecturer, RCSI SIM Centre for Simulation Education and Research Earlier this year, Dr Daly was awarded a Fulbright-TechImpact Scholarship to Stanford University Medical School in California, to develop a narrative-based medicine educational programme using simulation.

The Fulbright Awards enable outstanding candidates from across the island of Ireland to attend leading US institutions to research, study, teach and collaborate with experts in their fields.

Dr Daly, who is a non-invasive cardiologist interests include multimodality cardiovascular imaging, electrocardiography, and the education of multidisciplinary teams and medical students.

Conor De Barra, PhD Candidate, Immunology, Maynooth University Conor de Barra, PhD student in immunology at Maynooth University and Irish Research Council Scholar, has led work into the benefits of the popular obesity treatment drug, GLP-1.

Maynooth University’s Kathleen Londsdale Institute for Human Health Research has just published the ground-breaking research. Previous research has found that people with obesity are at a greater risk of developing cancer, in part due to their anticancer immune cell -- better known as the ‘Natural Killer (NK)’ cell -- being rendered useless due to their disease. New Health Research Board (HRB) funded research has found that the popular, and gold-standard pharmacological treatment for obesity, Glucagon-like peptide (GLP-1) analogues, can actually restore the NK cell function in the body including its ability to kill cancerous cells.

Ayat Elgammal, School of Pharmacy, University College Cork In September of this year, Ayat won the PCCA prize for the best poster presenter at the 15th conference of the European Paediatric Formulation Initiative (EuPFI) in Glasgow, UK. Ayat's PhD work involves identifying the attributes that aid the acceptability of paediatric oral formulations, in particular antibiotic formulations. She has received the best poster award at SSPC’s Medicine & Manufacturing Theme meeting, she was awarded the College of Medicine and Health doctoral student travel bursary to attend the PRIMM conference and won the firstplace prize in “My Research in a One Minute Video” competition at Bright Future event, College of Medicine and Health, UCC.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Professor John Fahy, University College Dublin Professor Fahy is the founder of Aer Therapeutics. The research-based spin-out is developing a novel small molecule mucolytic drug that, when inhaled, is designed to liquefy mucus plugs in the lungs of patients with chronic obstructive pulmonary disease (COPD).

Conventional COPD treatments such as bronchodilators and supplemental oxygen do not work to remove obstructions in the airway caused by mucus plugs. To address this, Professor Fahy and Professor Stefan Oscarson have developed the AER-01 drug in collaboration with Professor Anne Marie Healy’s pharmaceutical technology laboratory at Trinity College Dublin. Aer now plans to initiate phase 1 of its first-in-human clinical trial of AER-01 in mid-2023.

Cathy Farrell, Advanced Nurse Pracitioner, Heart Failure, Errigal Chronic Disease Management Hub Cathy is the former President and founding member of the Irish Association of Heart Failure Nurses Cathy Farrell. She has devoted 26 of her 27 years of nursing to cardiovascular care. She now offers support for a novice team of HF nurses, developing their skill set to deliver a comprehensive heart failure service across the hospital and community. Her commitment has resulted in a significant reduction in GP waiting time (18 months to 27 days) for assessment and diagnostics, a timely up-titration service and a reduction in cardiology clinic waiting times.

Cathy is a role model for both her team locally and nationally. She has contributed to initiatives such as national research projects, the development of heart failure e-learning modules, and has presented at national scientific meetings, webinars and contributed to the faculty of Euroheart care and ESC congress.

Dr Aoife Fleming, Lecturer in Clinical Pharmacy, School of Pharmacy, University College Cork Dr Fleming has been appointed Vice-Head for Interprofessional Learning at the College of Medicine and Health. Dr Fleming will promote the development of Interprofessional Learning (IPL) opportunities for students as well as supporting collaborative partnerships between College of Medicine and Health and the health services and promoting public and patient engagement in IPL education. She will lead an IPL action plan and work with a community of IPL advocates across Schools and Departments in CoMH to promote IPL education and research.

Dr Fleming was also appointed to the British Society for Antimicrobial Chemotherapy Council as a member in February 2023.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 James Gahan, Associate Professor, Centre for Chromosome Biology, University of Galway Dr Gahan has secured a prestigious grant award from the European Research Council to pursue scientific research on evolution and breast cancer. Dr James Gahan is currently a Research fellow at the University of Oxford and based at the Michael Sars Centre at the University of Bergen in Norway as a visiting researcher. He takes up an Associate Professor role in the School of Biological and Chemical Sciences and Centre for Chromosome Biology at University of Galway in April 2024 when the ERC Starting Grant commences.

Eimear Galvin, Manager, Health Innovation Hub Currently, based in St James's Hospital, Dublin, Eimear leads the Dublin (Trinity College Dublin) hub of HSE and Enterprise Ireland (EI) partnership, Health Innovation Hub Ireland (HIHI). As a member of the senior management team, she contributes to the national strategic direction of HIHI. Based on national health priorities, she delivers an expert function authoritative on health technology development, market insights and adoption pathways for Irish health tech startups and SMEs and clinical leaders in secondary care. She regularly collaborates with healthcare leaders to identify innovation gaps and provide solutions through client products. A recent success was a pilot delivered in partnership with Health Innovation Hub Ireland and with the St James’s Hospital TB team. The national TB study revealed a smart health option costs the HSE just 8 per cent (¤300) per patient, compared to current system cost of ¤3,362 per patient, over a six month treatment period.

Committed to placing innovation at the heart of Irish healthcare, Eimear also leads delivery of the HIHI Knowledge Network a national online toolkit designed to support Irish health innovators and accelerate innovation in the Irish health system.

Sadhbh Gash, Chief II Antimicrobial Stewardship Pharmacist, Beaumont Hospital Sadhbh Gash has been the Chief II Antimicrobial Stewardship manager since January 2023. Since that time she has transformed the promotion and awareness of antimicrobials stewardship on their wards, with their staff and with their processes. With the antimicrobial stewardship team Sadhbh has introduced three new weekly ward rounds; (C diff and antifungal) promoted IV to PO switch, oriented, trained and lead her new senior pharmacist in antimicrobial stewardship, captured KPIs on Antimicrobial Stewardship, targeted high cost antimicrobial therapies on ward rounds. Sadhbh has been invited to present on her work on Antimicrobial Stewardship Ward Rounds at the 11th Annual Quality and Patient Safety Meeting in Beaumont Hospital later this year.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Dr Claire Gillan, Associate Professor, Psychology, Trinity Institute of Neurosciences Dr Gillan has been awarded the Science Foundation Ireland Early Career Researcher of the Year title for 2023. Dr Gillan is an internationally renowned expert on mental illnesses, and was the first to show that patients with obsessive-compulsive disorder (OCD) have tendencies to form habits, a ground-breaking discovery in OCD that features in several undergraduate textbooks today.

Claire's lab at Trinity College Dublin is interested in developing novel approaches to studying brain health in psychiatric and ageing populations - a key goal is to develop objective tests that can be used to predict who will respond to which treatment.

To undertake this work, since joining Trinity, Claire has been awarded a fellowship from MQ: transforming mental health to study machine learning predictors of treatment response.

Professor Charles Gillham, Radiation Oncologist, St Luke’s Hospital/St James’s Hospital/National Lead, Sarcoma Professor Gillham was this year appointed as the new Network Director with St Luke's Radiation Oncology Network. Professor Gillham takes up the post having been a Consultant Radiation Oncologist in St Luke's Radiation Oncology Network for 15 years and the Clinical Lead at St Luke’s Centre at St James Hospital since 2013.

Professor Gillham sub-specialises in the radiotherapy treatment of sarcomas, gynaecological, colorectal and haematological malignancies. He is the National Lead for Sarcoma, co-founder of the Irish Sarcoma Group, an active member of Cancer Trials Ireland and since 2015 has been the Chief Examiner in Radiation Oncology for the Faculty of Radiology, Royal College of Surgeons in Ireland.

Professor Patricia Ging, Transplant/Pulmonary Hypertension Pharmacist, Mater Misericordiae University Hospital Professor Ging is the Transplant and Pulmonary Hypertension Pharmacist. As well as being committed to providing the best possible care to patients of the Transplant Unit she undertakes a number of voluntary roles relating to transplant care. She is currently chair of the Standards and Guidelines Committee of the International Society of Heart and Lung Transplant (ISHLT). She is the first pharmacist to lead in this role. Professor Ging is also the newsletter editor for the Solid Organ Transplant Pharmacist Group, this group helps pharmacists working in the niche area of solid organ transplant in Europe to network and engage in relevant professional development. The newsletter helps the group stay in contact between annual meetings. This year Patricia has been particularly involved in guideline development and teaching concerning improving reproductive health following transplant as well as ongoing work on the COVID-19 Task force of the ISHLT to improve the safe treatment of COVID-19 which has had a devastating impact on transplant recipients.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Professor Edward Gregg, Head of the School of Population Health, Royal College of Surgeons in Ireland A recently published review from Professor Gregg, points to the benefits and possible pitfalls of bringing data from the real world to bear on the future of managing diabetes. Furthermore, he has just been awarded ¤4.3 million in funding from Science Foundation Ireland (SFI) through its prestigious SFI Research Professorship Programme.

The award, which comes as a joint appointment with Imperial College London, will fund a new research centre at RCSI, Converge: Centre for Chronic Disease and Population Health Research.

The Centre will transform the way that population-level data and research platforms are deployed in Ireland to make key decisions for the prevention and reduction of the burden of chronic diseases.

Dzana Hadzic, Deputy Clinical Pharmacy Service Manager, Mater Misericordiae University Hospital Dzana was appointed as the MMUH critical care pharmacist in October 2020. Taking up the role in the midst of a pandemic, she demonstrated efficiency, commitment, and dedication by quickly reacting to and problem-solving emerging medication management issues, monitoring medication usage and planning for adequate supply of critical drugs. As the only Irish extracorporeal membrane oxygenation (ECMO) centre, Dzana is the only clinical pharmacist in the country working directly with adult patients requiring ECMO and has shown drive and initiative in researching and advising on complex ECMO-related drug issues. She continues to play an essential role within the multidisciplinary team by developing and updating treatment guidelines and providing pharmaceutical expertise to a highly complex patient population in the largest, most demanding critical care unit in the country. She was also involved in the planning of the unit's further expansion in 2023, liaising with key stakeholders in the project and advising on pharmacy-specific needs throughout the process.

Professor Orla Hardiman, Consultant Neurologist, Professor of Neurology, Beaumont Hospital/Trinity College Dublin Professor of Neurology at Trinity College, Consultant Neurologist at Beaumont Hospital, and National Clinical Lead, Neurology, at the Health Services Executive.

The prestigious award – selected by an international panel - recognises how Orla’s exceptional contribution to research has informed policy and practice in a way that positively impacts both the care and the well-being of patients living with neurodegenerative conditions and their families.

Tara Hayden, Senior Pharmaceutical Technician, St Luke’s Hospital, Kilkenny In times of crisis, such as the recent pandemic, Tara stepped up as a key player in managing the increased demand for pharmaceuticals in her role as a Senior Purchasing Pharmacy Technician. She demonstrated resilience and adaptability, working tirelessly to ensure uninterrupted access to medications for patients.

Tara has spearheaded initiatives aimed at optimizing workflows and enhancing patient safety, such as the introduction of ‘Patient-Specific Dispensing’ on hospital wards with her award winning poster highlighting how the project reduced omissions of medicines by 48%. Tara’s vision and determination has also led to the creation of a new Medicines Reconciliation training programme for Pharmacy Technicians in St Luke’s Hospital, Kilkenny. She is the Project Lead on this programme which she designed as a result of meticulous research, collaboration with healthcare professionals and an acute understanding of the intricacies involved in medication management.

She was recently commended as a RCSI Education Innovation Award finalist presenting her initiative with colleagues titled ‘Pharmacy Technician-led Dispensing Clinics – Empowering Pharmacy Students to Develop Core Skills’.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Dr Mona Heiland, Postdoctoral Researcher, SFI FutureNeuro Centre/Department of Physiology and Medical Physics, Royal College of Surgeons in Ireland Dr Heiland has been working on research that could lead to new treatments for epilepsy. She published a study this year which has identified a previously unknown ‘master controller’ of electrical signals in brain cells.

The study showed that the molecule could be a useful target for future medicines to help control seizures in epilepsy, which is one of the most common chronic brain diseases, affecting around 65 million people worldwide. Around one in three people with epilepsy have uncontrolled seizures despite being treated with currently available anti-seizure medication.

The study, which was published in the journal - Proceedings of the National Academy of Sciences of the United States of America (PNAS), took a broader look at what naturally controls how our brain cells communicate.

Dr Martina Hennessy, Associate Professor, Consultant Medical Education, Pharmacology & Therapeutics/Clinical Director, Wellcome HRB Research Facility Professor Hennessy has been given a Definitive Intervention and Feasibility Award (DIFA) to investigate significant challenges in patient care and treatment.

Professor Hennessy is the Director of the Wellcome HRB CRF at St James’s Hospital, Deputy Chair of HRB CRCI, Clinical Pharmacologist and Consultant physician at St James’s Hospital Dublin with clinical expertise in hypertension, cardiovascular risk and medication safety.

She is also an Associate Professor of Medical Education in the School of Medicine, Trinity College, Dublin. Martina’s research interests are in antiretroviral pharmacology, international development and medical education.

Professor David Henshall, Professor of Molecular Physiology & Neuroscience/Director, FutureNeuro Research Centre, Royal College of Surgeons in Ireland Professor Henshall funding of ¤1.5m for a new facility to support neurological research through the Science Foundation Ireland (SFI) Research Infrastructure Fund.

The RCSI funding was announced by Minister for Further and Higher Education, Research, Innovation and Science, Simon Harris TD, as part of an overall investment of ¤53.3 million for the advancement of high-quality and high-impact research activities in institutions across Ireland.

Professor Henshall is leading the new project to establish a Core Medium Throughput Facility at the University. The infrastructure will enable researchers to rapidly screen compounds and gene therapies for effects on the electrical activity of neurons in models of brain disease, establishing advanced drug discovery capabilities.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Dr Andrew Hogan, Lecturer, Immunology, Maynooth University/ Principal Investigator, Obesity Immunology Research Group Dr Hogan has been investigating MAIT cells for a master metabolic regulator and has found that MYC is essential for MAIT cells to take in nutrients, which are critical for them to function. It also found MYC is defective in people with obesity. Dr Hogan and his team has previously outlined in several papers how MAIT cells (which are a subset of immune cells) are defective in obesity. Last year, the team published findings showing that defective MAIT cells could directly drive insulin resistance by disrupting insulin signalling in children with obesity.

Audrey Houlihan, CEO, Royal College of Physicians of Ireland Audrey is the first female CEO to be appointed to this role at the college and joins RCPI from Our Lady’s Hospice and Care Services (OLHCS) where she is CEO. Audrey holds over 20 years’ experience in executive and senior leadership role within the not-for-profit sector.

During her tenure, she was appointed to several national committees and Director roles that provide advisory services related to policy, strategy and service development matters.

Gráinne Johnston, Chief II Pharmacist, Aseptic Compounding Service Manager, Mater Misericordiae University Hospital Gráinne has been working in the Mater Misericordiae University Hospital (MMUH) since she completed her intern year in the MMUH Pharmacy Department in 2015. In that time, Gráinne has undertaken a number of roles, including completion of a hospital pharmacy MSc. In April 2021, Gráinne took over the role of the MMUH Aseptic Compounding Service Manager (ACSM). Since her appointment, Gráinne progressed both the services offered by the MMUH Aseptic Compounding Unit (ACU) and also enhanced the staff roles within the service.

In service development, Gráinne played a pivotal role in the MMUH accreditation for the manufacture and administration of gene therapies involving genetically modified organism (GMO).

She has been instrumental for preparing the MMUH to be the National Centre for administration of Voretigene neparvovec (Luxturna®), a GMO for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy. A condition for which there was no previous treatment centres in Ireland.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Dr Conor Judge, Senior Lecturer of Applied Clinical Data Analytics, College of Medicine, Nursing and Health Sciences, University of Galway/Consultant Nephrologist, Saolta University Health Care Group Dr Judge has secured funding from the Health Research Board (HRB) to advance blood pressure treatment using artificial intelligence.

The project is set to revolutionise the management and treatment of hypertension, a critical health issue affecting more than 1.4 billion people around the world. The funding of ¤700,000 has been awarded under the HRB’s Clinician Scientist Fellowships (CSF) 2023 scheme.

The research project will run for four years and aims to address the significant care-gap in hypertension management, which currently requires people with the condition to visit their doctor frequently, thus posing a challenge to both the person with hypertension and the healthcare providers, by exploring the potential of artificial intelligence in enhancing treatment decisions.

Professor Brendan Kelly, Professor of Psychiatry, Trinity College Dublin/Tallaght University Hospital/HSE Professor Kelly has authored and co-authored over 300 publications in peer-reviewed journals, over 600 non-peer-reviewed publications, 21 book chapters and book contributions, and 19 books (13 as sole author).

Professor Kelly’s recent books include “Asylum: Inside Grangegorman”, which was published by the Royal Irish Academy in 2023. This book examines the history of the “Richmond Lunatic Asylum” (later St Brendan’s Hospital) at Grangegorman in Dublin which, in 1810, started an extraordinary programme of asylum building across Ireland.

Another recent book, also published in 2023, is titled “Resilience. Lessons From Sir William Wilde On Life After Covid.” Also in 2023, Professor Kelly co-edited, with Professor Mary Donnelly (UCC), the first edition of “The Routledge Handbook of Mental Health Law.”

Dr Christine Kelly, Assistant Professor, School of Medicine, University College Dublin More than one million euro in funding has been awarded to a UCD research team led by Dr Kelly under a key pillar of the Health Research Board’s (HRB) efforts to support the career development of outstanding researchers in health and social care.

Dr Kelly, a Clinician specialising in Infectious Diseases, General Internal Medicine and Clinical Virology, received the funding under the HRB’s prestigious dual-track Postdoctoral Fellowship schemes, Applying Research in Policy and Practice (ARPP) and the Clinician Scientist Fellowships (CSF). Dr Kelly’s project – awarded ¤1.2m under the CSF scheme – will examine how to improve detection of new infectious threats in people who have recently travelled through the establishment of a surveillance system for healthcare professionals.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Professor John Kelly, Fellow Emeritus, Chemistry, Trinity College Dublin Profesor Kelly has emerged as winner in the recently announced Definitive Intervention and Feasibility Awards (DIFA) 2023 results. His research project is titled, OSITRON - PsilOcybin with pSychologIcal supporT foR cOcaiNe - A pilot feasibility trial of psilocybin therapy for cocaine use disorder’ and it is envisaged that this pilot feasibility study will provide the necessary preliminary data to pave the way for a larger clinical trial to assess if psilocybin with psychological support will promote cocaine abstinence, reduce craving, and reduce rates of relapse in treatment seeking adults with cocaine use disorder.

Mr Ronan Kelly, Consultant Cardiothoracic Surgeon, Galway University Hospitals Mr Kelly is part of the team at University Hospital Galway who have just introduced a new minimally invasive surgery for coro nary artery bypass grafting.

The endoscopic radial harvest programme reduces significantly the risk of complications and infection for the patient.

The procedure was carried out for the first time in Ireland by Mr Kelly and his team as part of the minimal access surgery programme in the Department of Cardiothoracic Surgery, University Hospital Galway.

Dr Cormac Kennedy, Consultant Clinical Pharmacologist/Physician, St James’s Hospital/Assistant Director, Wellcome HRB Clinical Research Facility Dr Kennedy is completing research on Semaglutide for people with obesity and resistant hypertension trial (SUPPORT): a pilot randomised, double blind, parallel group, multicentre trial. This important project has been given a Definitive Intervention and Feasibility Award.

The research question is whether a weight-centric approach, using semaglutide, for patients with obesity and RH, but without diabetes, results in a clinically meaningful reduction in BP versus standard care. A pilot randomised, double blind, parallel group, multicentre trial will be performed to inform an international, multicentre definite study.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Professor Rose Anne Kenny, Founding Principal Investigator, The Irish Longitudinal Study on Ageing (TILDA) Professor Kenny has become the first ever female Regius Professorship of Physic (1637) at Trinity College Dublin.

Professor Kenny becomes the first female physician to take the prestigious seat, which has been held by 23 prior distinguished professors over the centuries including the famous John Stearne, William Stokes and Victor Synge. It was awarded first to Dr John Stearne (1662), best known as the founder of the Royal College of Physicians of Ireland.

Joanne Kissane, Registrar and Chief Officer, The Pharmaceutical Society of Ireland Earlier this year, the Pharmaceutical Society of Ireland published the first report of its kind in Ireland examining the emerging risks to the future availability of pharmacists in patient-facing settings was launched today in the Department of Health by Secretary General Robert Watt.

The Workforce Intelligence Report commissioned by the PSI -the Pharmacy Regulator, examines the current challenges to the recruitment and retention of pharmacists in community and hospital settings and provides, for the first time, baseline data on emerging risks specific to this cohort.

Its aim is to provide for a sustainable supply of pharmacists to meet current and future needs in patient- facing settings, and to enable pharmacy to play a full role in the development of the future integrated healthcare system.

Professor Veronica Lambert, Professor of Children and Family Nursing/Head of School of Nursing, Psychotherapy and Community Health, Dublin City University This year, in a competitive funding call, Professor Lambert acted as a role model for peers and colleagues, by leading a successful Health Research Board Applied Partnership Award in partnership with Barretstown Children’s Charity, for a project entitled “memory-making through therapeutic recreation for families of children with life-threatening conditions receiving palliative care at home: Adaptation of a digital storytelling legacy intervention.” This research will review how digital storytelling is used in the United States, and work with stakeholders and families to map similarities and differences between there and Ireland. Prof Lambert will work with Barretstown to integrate their unique model of therapeutic recreation and tailor the US digital storytelling intervention to the Irish context.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Professor Carel Le Roux, Professor of Chemical Pathology, School of Medicine, University College Dublin First-time patients in need of bariatric surgery will now be able to predict their weight loss ahead of undergoing a gastric bypass or sleeve gastrectomy operation thanks to work being undertaken

by Professor Carel Le Roux and team. A new AI driven web-tool developed by University of Lille and supported by the European Union SOPHIA project led by University College Dublin now allows patients and their doctors to accurately predict weight loss over five years following different types of bariatric surgery.

Professor Le Roux, is co-ordinator of the SOPHIA consortium. The prediction tool is the most accurate approach to predicting weight loss post-surgery created so far, and is likely to only improve over the next two years given the on-going European Union project SOPHIA’s investment.

Dr Alison Liddy, Principal Investigator, NUI Galway Dr Liddy this year received the title of Science Foundation Ireland Commercialisation Award. Dr Liddy and her team are developing a novel, disruptive, treatment for chronic pain without the usual addictive side-effects current treatments possess. This advancement has the potential not only for a transformative impact on the lives of those suffering from chronic pain but also has the potential to reduce the significant negative societal impact associated with prescription drug addiction.

Currently, Dr Liddy is a principal investigator leading Science Foundation Ireland’s first ever Challenge-based award, the SFI Future Innovator Prize. This Hydrobloc project aims to develop a new treatment for osteoarthritis pain. With more than 40 million Europeans affected by osteoarthritis, with no treatment offering patients long lasting pain relief, this project hopes to transform the lives of these patients.

Theresa Lowry-Lehnan PhD, Clinical Nurse Specialist/ Associate Lecturer, South East Technical University, Carlow Campus Theresa is a regular contributor to medical, nursing and pharmaceutical journals and medical newspaper publications, with over 200 clinical articles published in recent years. Her academic work has been used to create CPD modules across the disciplines for Doctors, Nurses and Pharmacy teams. In March of this year, Theresa was presented with the prestigious ‘Nurse Educator’ award by Rachel Kenna, Chief Nursing Officer at the Department of Health, at the Irish Nurses Cardiovascular Association’s (INCA) 25th Jubilee.

In May 2023, Theresa was awarded both the ‘Community Nursing Project of the Year’ and the ‘Student Intervention’ of the year awards at the Irish Healthcare Centre Awards for her Nurse Prescriber (RNP) delivered Free Contraception and Sexual Health Services for Third Level Students, at South East Technological University, Carlow Campus. In the past 12 months, she carried out over 1,700 complete episodes of care for contraception and sexual health/ STI consultations in her practice.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Professor Sally Ann Lynch, Consultant Geneticist, CHI Crumlin & CHI Temple Street/Clinical Professor, School of Medicine, University College Dublin Professor Lynch won the inaugural HRCI Research Impact Award. She has been recognised for her work in understanding the genetics of rare diseases and for sharing digestible information about genetics with the wider world.

Professor Lynch’s work received more than ¤300,000 under the HRCI/HRB Joint Funding Scheme in the decade to 2020 and was supported by the National Children’s Research Centre and the Children’s Health Foundation, Temple Street.

The scheme offers charities, who are members of HRCI, the opportunity to receive matching funding from the HRB for research projects that they believe will make a difference. A total of 153 awards have been made since the inception of the scheme, investigating a wide range of common and rare health challenges.

Professor Jonathan Lyne, Director, Cardiac Electrophysiology/Consultant Cardiologist/ Electrophysiologist, Beacon Hospital Professor Lyne was at the forefront as Beacon Hospital announced completion of its first ablation case performed using the Medtronic Affera™ Mapping and Ablation System. The surgery was performed

by Professor Jonathan Lyne, Consultant Cardiologist and Electrophysiologist along with Beacon Hospital’s Cath Lab team.

As well as being the first hospital in Ireland and the UK to perform the pioneering treatment, Beacon Hospital is among the first five hospitals worldwide to carry out the procedure.

Professor Rustom Maneckshka, Consultant Urological Surgeon, Tallaght University Hospital A team led by Consultant Urologist Professor Manecksha carried out a new type of minimally invasive procedure treating BPH in the Reeves Day Surgery Centre at Tallaght University Hospital.

The innovative treatment (Rezum) uses water vapour therapy to target and shrink the excess prostate tissue. When the steam contacts the prostate tissue the stored energy is release into the tissue. In time the body absorbs the treated tissue, reducing the size of the prostate. This relieves the urinary obstruction and improves urinary flow.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Dr Christine McCarthy, Stroke and Geriatric Physician, PhD Researcher, College of Medicine, Nursing and Health Sciences, University of Galway Dr McCarthy has led a global study into causes of stroke and in the process has identified that sleep problems - including getting too much or too little sleep, taking long naps, snoring, snorting and sleep apnoea - can increase the likelihood of having a stroke.

The research was published in the medical journal of the American Academy of Neurology.

The study found that breathing problems during sleep, including snoring, snorting, and sleep apnoea were significantly associated with stroke. Participants who reported sleep apnoea and snorting were nearly three times more likely to have a stroke, while people who snored were nearly twice more likely to have a stroke than those who did not.

Dr Peter McCarthy, Consultant Haematologist Adolescent & Young Adult Haematology, Children’s Health Ireland at Crumlin/St James’s Hospital Dr McCarthy is Ireland’s first dedicated Adolescent & Young Adult (AYA) Cancer focused Consultant Haematologist.

His appointment in June 2023 across Children’s Health Ireland at Crumlin and St James’s followed a career pathway which has seen him excel in teaching, academic pursuits, clinical excellence and in the charity sector.

He has secured a number of competitive grants, including an Irish Research Scholarship Aware, to characterise an incredibly underserved population - children and adolescents in Tanzania with acute lymphoblastic leukaemia. This project (the SALAMA project), is a collaboration with Dr Trish Scanlan, a pioneering Irish doctor who has established The National Children’s Oncology Centre in Tanzania. It will molecularly characterise the disease experienced by this group of patients for the first time.

A clinical leader in AYA cancer in Ireland, Peter is a co-founder of AYA Cancer Ireland, a special interest group for healthcare professionals who care for this population. Through this, he works to disseminate the knowledge and expertise essential to support these young people during difficult circumstances.

Professor Ray McDermott, Clinical Professor of Medical Oncology, Tallaght University Hospital Professor Mc Dermott was one of the principal investigators for the TRITON 3 Trial, which has discovered that the drug Rucaparib is successful in the treatment of certain prostate cancers.

He was also the second highest recruiter globally for the TRITON 3 trial and supervised care to the men taking part in this important new research which was partly carried out in Ireland to find better treatments for prostate cancer. 17 patients (13 of these in TUH) had the required genes and met all other eligibility criteria and proceeded to the main trial.

Professor McDermott is the National Cancer ControI Programme lead in guideline development for prostate cancer.

Medical researchers at Tallaght University Hospital (TUH) have taken part in a ground-breaking Clinical Trial The trial which began in TUH in 2017, was called TRITON 3.

Dr Natalie McEvoy, StAR Research Lecturer in Critical Care Nursing, Department of Anaesthesia and Critical care, Royal College of Surgeons in Ireland Dr McEvoy is an Irish Research Council Awardee and was awarded her PhD by the School of Nursing and Midwifery at the RCSI in 2022. She is an active committee member of the Irish Association of Critical Care Nurses (IACCN), leading the research division for the committee. She is also chair of the All-Ireland Critical Care Nursing Research Group.

She has over 40 peer reviewed publications in Q1 journals since commencing her PhD in 2019. Natalie was also recently awarded a research residency award from the Embassy of France in Ireland to conduct research on necrotizing wounds in ICU at Université Paris-Est Créteil (UPEC). In September 2023, Natalie was selected as the RCSI nominee for the Irish Research Council Researcher of the Year award. More recently, Natalie was awarded a Fulbright 2023-2024 Scholarship to travel to the Children's Hospital of Philadelphia and PENN Nursing to work with Professor Martha Curley and her team.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Dr Fiona McGillicuddy, Lecturer/Assistant Professor, School of Medicine, University College Dublin Dr McGillicuddy is one of the leaders of the Medtech start-up, which is focused on transforming obesity care. She and her team have won the 2022 University College Dublin Start-Up of the Year Award.

MetHealth received the award, and its ¤30,000 prize fund, after being declared the overall winner of the 2022 UCD VentureLaunch Accelerator Programme – which aims to equip its participants with the knowledge and skills required to work as part of a team leading a new commercial venture.

As winners of 'Start-Up of the Year' MetHealth will receive a prize package worth ¤30,000, which includes a ¤10,000 cash prize sponsored by AMD, a professional service package sponsored by Deloitte and Bryan Maguire Financial Services and incubation space at NovaUCD.

Ashleigh Meagher, Aseptic Compounding Service Manager/ Cancer Services, Mater Misericordiae University Hospital In October 2023, Ashleigh Meagher was appointed the role of Aseptic Compounding Service Manager in the Mater Misericordiae University Hospital (MMUH). Ashleigh supports the management of a progressive team of specialist pharmacists and pharmacy technicians in a fast-paced, evolving environment to ensure the sterile, safe manufacture and delivery of systemic anti-cancer therapy to both MMUH inpatients and outpatients. Ashleigh has been involved in the training and education of new staff members, development of local policies and procedures, and liaison with MMUH Cancer Directorate staff to optimise efficiencies to drive excellence in cancer care.

Over the course of Ashleigh’s time in the MMUH, she has become an integral part of the cancer care team aiding patient medication management from diagnosis to survivorship and provision of patient and staff education. Ashleigh has provided a clinical pharmacy service to MMUH cancer inpatients, she has participated in the Oncology / Haematology Clinical Trial service provision and improved drug accessibility through the MMUH involvement with Managed Access Programmes. Ashleigh is the pharmacy representative for the Multi Centre Clinical Trials Advisory Group (MCCTAG) in MMUH.

Dr Frank Moriarty, Pharmacist/Senior Lecturer, School of Pharmacy & Biomedical Scieneces, Royal College of Surgeons in Ireland Dr Moriarty has received a ¤2.4 million Career Development Award from Wellcome to advance new methods to research deprescribing– the planned process of reducing or stopping medicines that may no longer be of benefit or may be causing harm.

The research funded in this award will harness the large amounts of information already collected as part of routine healthcare, such as GP and hospital visits. New methods from pharmacoepidemiology will be used to analyse these datasets, to improve our understanding of deprescribing practices. As the focus of healthcare shifts to more personalised medicine and patient-centered approaches, research in this area will inform the decisions of patients and their healthcare professionals and support optimal treatment.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Professor Micheal Morris, AMBER Director/ Founder, Glantreo Professor Morris was awarded the Science Foundation Ireland Best International Engagement Award, in recognition of his long-standing association and engagement with international companies, researchers, and policy makers. Professor Morris is a professor of Surface and Interface Chemistry at Trinity College Dublin and the director of AMBER, the SFI Research Centre for Advanced Materials and BioEngineering Research, who has spearheaded the facility for the last 7 years.

He is the first European scientist to be awarded three or more awards from the Semiconductor Research Council in the United States He has promoted the circular economy internationally and has engaged with researchers and policy makers in the United States, Turkey, Switzerland and the UK and is a member of the European Materials Characterisation. He is the lead PI on DeMANS, an MSCA programme on developing printable biopolymers which involve companies and universities across Europe as well as New Zealand and Australia.

Katherine Morrow, Director/National Co-ordinator, APPEL/President, The Pharmaceutical Society of Ireland Katherine is the President of the Pharmaceutical Society of Ireland and earlier this year they launched the first ever pharmacy intelligence workforce report. Katherine is Director and National Coordinator of APPEL (Affiliation of Pharmacy Practice Experiential Learning) with responsibility for the experiential learning placements of the integrated pharmacy programmes of the three Schools of Pharmacy in Ireland. A graduate of the School of Pharmacy, Nottingham University, Katherine has over 25 years’ experience, acquired from working across a breadth of sectors including primary care, secondary care, regulation and academia.

Dr Evelyn Murphy, PROGRESS Women in Surgery Fellowship Dr Murphy has been announced by the Royal College of Surgeons in Ireland (RCSI) as the recipient of the 2023 PROGRESS Women in Surgery Fellowship.

The prestigious bursary, awarded by RCSI and supported by Olympus Medical, promotes female participation in surgical training at Fellowship level.

Dr Murphy will undertake a Fellowship in Minimally Invasive Surgery and Orthopaedic Foot and Ankle Surgery in Sydney. It will incorporate percutaneous surgery, sports surgery, trauma and total ankle replacement, covering basic and complex fusions and osteotomies and forefoot reconstructions.

Following the Fellowship, Dr Murphy will be one of the pioneers in this field in Ireland.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Dr Robert Murphy, Consultant Stroke Physician, College of Medicine, Nursing & Health Sciences, University of Galway In March of this year, Dr Murphy authored a study which found that people with symptoms of depression were more likely to suffer an acute stroke and have a worse recovery afterwards. The findings come from a new INTERSTROKE study.

INTERSTROKE is a global study of 26,877 adults with an average age of 62, across 32 countries including participants in Europe, Asia, North and South America, the Middle East and Africa. Participants with stroke were matched to controls who had not suffered a stroke, but were similar in age, gender, racial or ethnic identity.

Professor Jarushka Naidoo, Consultant Medical Oncologist, Beaumont Hospital/Academic Professor of Medical Oncology, Department of Medicine, Royal College of Surgeons in Ireland Professor Naidoo has been appointed as Academic Professor of Medical Oncology in the RCSI Department of Medicine. Professor Naidoo will lead RCSI’s innovative medical cancer research team to further its growth and development, and continue its work to secure funding for vital international cancer research.

In her career to date, Professor Naidoo has developed and led a portfolio of clinical trials and translational studies in lung cancer, immunotherapy and immune-related toxicity. She is an established leader in these fields with over one hundred articles published in publications such as New England Journal of Medicine, Journal of Clinical Oncology and JAMA Oncology.

Dr Werd Al-Najim, Clinical Nutritionist/Research Fellow, University College Dublin Dr Al-Najim is one of the senior team members of a UCD School of Medicine spin-out – Beyondbmi. Beyondbmi, a University College Dublin (UCD) HealthTech spin-out company supported by NovaUCD, has announced closing a ¤525,000 pre-seed funding round, advised by CKS Finance.

Beyondbmi has developed a 12-month weight management programme, designed by the leading medical weight management experts, to enable clients achieve long-term weight loss and health gain in a sustainable way. Beyondbmi uses the latest scientific research and therapies to create individually tailored treatment plans which includes detailed assessments, medication, dietary plan, and behavioural health adjustments.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Mr Greg Nason, Urology Consultant, Mater Misericordiae University Hospital Mr Nason's special interests lie in prostate and bladder cancer, and he has received specialised training in robotic prostatectomy and robotic cystectomy. Notably, he played a pivotal role in setting up the first comprehensive robotic bladder cancer program in Ireland. As explained by Mr Nason on RTE one’s “Hospital Live”, this surgical approach affords patients less post operative pain, smaller incisions and a shorter hospital stay. Beyond his clinical contributions, Mr. Nason has made significant strides in clinical research with over 100 peer-reviewed publications, three book chapters and more than 50 academic presentations. He has been awarded numerous national and international awards and has consistently demonstrated his dedication to advancing urologic science. His dual role as an examiner at both undergraduate and postgraduate levels at the RCSI and UCD underscores his dedication to nurturing the next generation of urologists.

Dr Cathal O’Connor, Fellow in Paediatric Dermatology, University College Cork Dr O’Connor is a fellow in paediatric dermatology with the Royal College of Physicians of Ireland (RCPI) and the Irish Clinical Academic Training programme, and is dual training in general paediatrics. This year he was chosen as a ‘Future Leader’ of the European Society of Dermatological Research at their annual academy in Madrid, and he has also been named as a ‘Future Leader’ of the European Society of Paediatric Dermatology. This year Cathal won the top award at the British Association of Paediatric Dermatology’s annual meeting for his research into novel multispectral imaging for paediatric morphoea. He also won the prestigious Burrows Cup at the Irish Association of Dermatology’s annual meeting for his research into sleep disruption in infants with atopic dermatitis. Dr O’Connor is the programme lead for the RCPI’s postgraduate diploma in dermatology, delivering teaching to doctors, nurses, and other healthcare workers all over the world.

Máiréad O’Connor, Pharmacy Lead, Infectious Diseases, Mater Misericordiae University Hospital Máiréad is the Pharmacy Lead for Infectious Diseases in the Mater Hospital, leading a team of 6 staff including pharmacists, a pharmacy technician and a pharmacy aide in the care of almost 2000 patients attending the MMUH Infectious Diseases (ID) & Hepatology services. Through her role as Pharmacy Lead, Máiréad has developed the MMUH ID Pharmacy service to meet the growing needs of an increasingly complex patient cohort.

This has included adaption of service delivery to facilitate injectable antiretroviral treatment, rapid expansion of the STI service; including the introduction of an MPox vaccination service, the introduction of a Managed Access Programme for novel anti-fungal agents and active participation in clinical research through collaboration with CEPHR (UCD Centre for Pathogen Host Research) and MMUH colleagues, among other things.

As the Pharmacy Lead for Infectious Diseases and The National Isolation Unit Pharmacist, Máiréad is considered an expert in Infectious Diseases. In recognition of this expertise, she has been invited to participate in The National High Consequence Infectious Disease Clinical Advisory Subgroup and has contributed to National Clinical Guidance on Tecovirimat for Mpox Infection. Máiréad and colleagues (both pharmacy and wider MDT colleagues) are members of the planning groups for the MMUH Emergency Wing development and service implementation, including a new state of the art National Isolation Unit.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Professor Lorraine O’Driscoll, Professor of Pharmacology & Biomedicine, Trinity College Dublin Professor O’Driscoll has championed exosomes and other extracellular vesicles (collectively EVs) in health and disease as a niche research area in Ireland, based on her/her team’s seminal discoveries in relation to EVs in health and disease. For example, in disease conditions the O’Driscoll team were first in the world to discover that EVs are casually involved in transmitting anti-cancer drug resistance, in additional to immune suppression and spread of cancer as metastases.

She founded and led the largest funded international EVs research consortium that has existed to date, bringing together scientist and clinical researchers from 27 European countries, 3 US universities, Australia and 7 industry partners. She also founded and led the first European academia/industry/clinical research consortium, training 15 PhD students. Professor O’Driscoll is an Irish Research Council Advanced Laurate Awardee. A total of twelve such awards have made across all disciplines; 3 to females., with Professor O’Driscoll being the only female recipient in science, technology, engineering, and maths (STEM).

Asst Professor Fardod O’Kelly, Consultant Paediatric & Adolescent Urological Surgeon/Senior Lecturer, Academic Affairs, Royal College of Surgeons in Ireland Assistant Professor O’Kelly has been working as a paediatric and adolescent urological surgeon in the private sector since returning home from fellowship training in 2020. He continues to work with the European Association of Urology to develop guidelines on transitional and adult congenital care for urological patients and is currently in the early stages of developing a public sector program for this in Ireland in conjunction with the RCSI. He is as an assistant professor in University College Dublin, an adjunct assistant professor at the University of Wisconsin, and is an academic Senior Lecturer in Surgical Affairs in the RCSI where he trains postgraduate surgeons, ophthalmologists, radiologists, international medical graduates and emergency medicine trainees in human factors, and researches and teaches on the associated MSc program. He continues to collaborate with colleagues in North America and Europe and has started to introduce business and medical law teaching to postgraduate training in surgery to prepare future surgical consultants for practice, as well as examining both undergraduates and postgraduates in UCD and the RCSI. He has recently commenced an MSc in Law and Ethics through the RCSI and is Ireland’s first recipient of the Association of MBAs/Business Graduates Association’ MBA Student of the Year in 2022.

Professor Caitriona O'Driscoll, Chair of Pharmaceutics, School of Pharmacy, University College Cork In 2023, Professor O'Driscoll was been appointed to the Expert Taskforce to Support the Expansion of the Role of Pharmacy.

The Taskforce, which was established by Minister for Health Stephen Donnelly, will examine how pharmacists can be better used in the healthcare system.

As a member of the Taskforce, she will bring her 20+ year commitment to pharmacy education and practice to help develop recommendations on how pharmacists can be better used in the healthcare system. This includes prescribing medicines, providing vaccinations and other preventive care, and managing chronic diseases.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Professor John O’Leary, Professor Consultant, Histopathology/Professor Consultant, Molecular Medicine Ireland, Trinity College Dublin Professor O’Leary is leading a team of scientists from Trinity College Dublin who have made a landmark breakthrough, identifying three new biomarkers for prostate cancer to help identify and differentiate potentially aggressive cases of the disease.

The team has identified three new biomarkers which will allow pathologists to determine which patients require immediate, radical treatment compared to those who need close monitoring.

With more than one million men diagnosed with prostate cancer worldwide each year, the research breakthrough is significant.

Niamh O’Sullivan, Assistant Director of Nursing, Midwifery & Young Adult Cancer, Children’s Health Ireland at Crumlin/St James’s Hospital Niamh O’Sullivan, Ireland’s first ADON for AYA Cancer, has been a trailblazer for Adolescent and Young Adult (AYA) cancer nursing in Ireland, in a career that has spanned continents. In her current role, she leads a dynamic group of healthcare professionals in developing a dedicated, young-person centred cancer service. A strong believer in patient involvement, she has recently established a research priority setting partnership with young people with lived experience of cancer. Niamh was a core member of the team which produced the Framework for the Care and Support of Adolescents & Young Adults with Cancer in Ireland along with colleagues through the NCCP. Niamh is a key member of Children’s Health Ireland’s Youth Advisory Council, working to amplify and centre the voice of young people as CHI transitions to the New National Children’s Hospital.

Professor Stefan Oscarson, Professor of Chemical Biology, University College Dublin Professor Oscarson is co-founder of Aer Therapeutics, who are developing a novel drug to help COPD patients breathe easier. The research-based spin-out is developing a novel small molecule mucolytic drug that, when inhaled, is designed to liquefy mucus plugs in the lungs of patients with chronic obstructive pulmonary disease (COPD).

Conventional COPD treatments such as bronchodilators and supplemental oxygen do not work to remove obstructions in the airway caused by mucus plugs. To address this Professor Oscarson, together with Professor John Fahy, has developed the AER-01 drug in collaboration with Prof Anne Marie Healy’s pharmaceutical technology laboratory at Trinity College Dublin.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Professor Juan Carlos Puyana, O’Brien Chair of Global Surgery, Royal College of Surgeons in Ireland Medicine & Health Sciences Professor Juan Carlos Puyana has been appointed O’Brien Chair of Global Surgery at RCSI University of Medicine and Health Sciences. Professor Puyana will lead the university’s Institute of Global Surgery in its work to improve access to high-quality, essential surgical care for underserved populations.

Professor Puyana joins RCSI from the University of Pittsburgh where he was Director of Global Health-Surgery. He is a renowned trauma/ acute care surgeon and a global health educator.

Professor Puyana is an expert in developing international capacity-building programmes in trauma, trauma registries, and trauma datasets in global surgery. He has established reciprocal mentoring collaborations with several universities and trauma centres from Latin America and Kenya.

Catriona Reddin, Specialist Registrar, Geriatric Medicine & General Internal Medicine, Galway University Hospital Dr Reddin is working on increasing access to clinical trials for older people, working with a team at the Institute for Clinical Trials in Galway to ensure scientific advances are transplated into improve care for older patients.

She is currently completing a PhD exploring the association between dietary factors and falls; within this, she is gaining training in clinical trials supported by the Institute. With access to trials and innovation in medical products, she hopes to make dramatic changes in healthcare to improve quality of life and maintain independence for older people.

Elaine Redmond, Consultant Urologist, Cork University Hospital Ms Redmond is a Consultant Urologist at Cork University Hospital with a special interest in adult and paediatric reconstruction. She is one of the few urologists in Ireland providing urology care to both adult and paediatric patients. She is a serving member of the GURS Young Reconstructive Urologists committee and EAU Young Academic Urologists Reconstructive Working Group. She has been invited to speak and share her expertise at several conferences and educational webinars, including meetings organised by international societies such as the EAU Section of Genitourinary Reconstructive Surgeons (ESGURS) and the Society of Genitourinary Reconstructive Surgeons (GURS). On a national level, she is a senior clinical lecturer with the University College of Cork and a surgical trainer for the Urology Higher Surgical Training scheme.

Her research has earned her numerous accolades, including the Irish Society of Urology Research Medal in 2013. She received the Colles Fellowship in 2019 and has been awarded the prestigious Ainsworth Scholarship on two occasions (2019, 2020). Ms. Elaine Redmond is not only a distinguished urologist but also a role model for aspiring young female surgeons in Ireland.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Dr Aideen Ryan, Lecturer, Foundation Research Lecturer in Tumour Immunology, NUI Galway Professor Ryan is leading research studying cell interactions in bowel cancer and, along with her team, has identified innovative strategies to enhance how the body and drug treatments fight the disease. The research showed that stromal cells, when exposed to inflammatory molecules released by bowel cancer cells, express increased amounts of the sialoglycans - on their surface.

It also showed that T cells could be re-activated by using specific drugs to disrupt the binding between the cells.

Professor Faisal Shariff, Professor in Translational Cardiovascular Medicine & Innovation, NUI Galway/Clinical Director, Advisory Board Member, BioInnovate Ireland Professor Shariff is the principal investigator for a clinical trial which reduces the hospitalisation rate for patients living with heart failure. The trial which allows patients to be treated for heart failure from home has the potential to be a game changer in the treatment and monitoring of the condition.

The Cordella Pulmonary Artery Pressure Sensor detects changes in the health of patients with heart failure and securely transmits the information to the care team for review. If a change is detected, the team can then make changes to medications or other clinical interventions to prevent a heart failure flare-up requiring urgent hospitalisation.

Professor Orla Sheils, Vice-Provost/Chief Academic Officer, Trinity College Dublin Professor Sheils, the Vice-Provost and Chief Academic Officer at Trinity College Dublin, was this year named a Doctor in Science at the University in recognition of her outstanding contribution to the advancement of knowledge. This award requires a higher level of attainment than a PhD. Professor Sheils, who is a renowned cancer researcher, was also this week appointed elected as a member of the Scientific Council of the International Agency for Research on Cancer for 2024-27.

IARC is a cancer research agency of the World Health Organization that supports cancer prevention research.

Dr Sadiq Siddiqui, Registrar Cardiothoracic Surgery, University Hospital Galway Dr Siddiqui has carried out a new minimally invasive surgery for coronary artery bypass grafting, making University Hospital Galway the first hospital in the country to do so. After performing over 400 endoscopic saphenous vein harvests (EVH) in Galway as part of coronary artery bypass operations, Dr Siddiqui travelled to the Royal Brompton National Heart Hospital in London to further his training in endoscopic surgery. There he trained in this new technique to also harvest the radial artery from the left forearm.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Professor Susan Smith, Professor of General Medicine, Trinity College Dublin Professor Smith has emerged as winner of a recently announced Definitive Intervention and Feasibility Award for 2023. The title of her project is Medicines and SocIal Prescribing to address patient priorities in multimorbidity (MIDAS): A multi-arm (definitive) cluster randomized trial in Irish general practice.

The MIDAS trial aims to evaluate the clinical and cost-effectiveness of two separate multimorbidity interventions to support GPs managing medicines (MyComrade) and to support patients addressing their priorities (LinkMM) in order to improve patients’ health outcomes, experience of care and well-being.

Professor Suja Somanadhan, Associate Professor/ Head, Children’s (Paediatric) Nursing/Programme Director, Emergency Nursing, University College Dublin Professor Somanadhan is the co-lead for RAiN - the All-Ireland Rare Disease Interdisciplinary Research Network, which was launched earlier this year. Individual rare diseases may be rare but collectively impact more than 400,000 people across the island of Ireland. There are as many people living with rare diseases across Ireland as live with diabetes, yet rare diseases receive much less recognition and support.

RAiN will help evaluate the quality of life and management of people living with rare diseases on the island of Ireland and internationally.

Professor Judith Strawbridge, Deputy Head, School of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences In July of this year, Professor Strawbridge was appointed to the Expert Taskforce to Support Expansion of the Role of Pharmacy.

Established by Minister for Health Stephen Donnelly, the taskforce will examine how pharmacists in Ireland can be enabled to operate at the top of their licence for the benefit of patients and the wider health service.

Professor Strawbridge was a founding lecturer on the pharmacy degree programme at RCSI and is currently Deputy Head (Education) of the School of Pharmacy and Biomolecular Sciences and Director of the Masters of Pharmacy (MPharm) Programme. She is widely recognised nationally for her scholarly expertise and passion for standards in pharmacy education and practice.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Dr Vinod Sudhit, Consultant in Anaesthesia & Intensive Care, Saolta University Health Care Group Dr Sudhit and team at Portiuncula University Hospital has launched the ‘Little Journey’ virtual reality app to help children between the ages of 3 and 12, to prepare for surgery and allay their anxiety in advance of their hospital stay.

The ‘Little Journey’ app provides 360 degree views of all the areas the children will visit at the hospital as well as useful information about anaesthesiology tailored to the age of the child.

“The ‘Little Journey’ app was developed to help change the way children experience hospitals by empowering them and giving them the information they need to reduce their anxiety in a fun, interactive format. The app helps children to familiarise themselves with the hospital and the handy checklists included will help families to prepare in advance of the hospital stay.”

Richard Sykes, Chief I Pharmacist, Portiuncula Hospital/ President, Hospital Pharmacists Association of Ireland Richard is the President of the Hospital Pharmacists Association of Ireland. At the start of this year, HPAI successfully negotiated a new deal for the profession to include pay rises of around 20% for many pharmacists, and the creation of some new, higher grades. The dispute related to the implementation of the Hospital Pharmacy Review, a report compiled by Dr Ambrose McLoughlin which was originally delivered in November 2011 and then updated in 2017.

It provided for shorter pay scales for hospital pharmacists along with an enhanced career structure and the creation of new senior grades. This was to be done in return for cost-saving measures, the value of which was ultimately put at ¤55 million.

Jayne Tuthill, Acting Drug Safety Facilitator, Mater Misericordiae University Hospital In 2022, Jayne was appointed as the MMUH Acting Drug Safety Facilitator, resulting in Jayne managing the Drug Safety Service for the last 11 months in resource-limited times. Despite the challenges, Jayne consistently delivers an excellent service output. The priority is medication variance follow-up and escalation, however, Jayne also led high-risk drug audits and drug safety and educational initiatives throughout the hospital.

Jayne is an active member of the MMUH Drug Safety & Drugs & Therapeutics Committees, Acting Chair, Drug Safety Committee Insulin Subgroup, & pharmacy /drug safety representative on the Falls Committee, Psychiatry Governance Committee, Procedural Sedation Committee & VTEQI group.

Jayne has overseen the introduction of a drug safety pharmacy technician post to support medication variance processing. This is the first drug safety pharmacy technician role in the MMUH. Jayne was a MMUH Compassion Award 2023 Nominee.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Professional 100 Dr Ruairi Waters, Consultant in Geriatric Medicine, Galway University Hospital Dr Waters is Co-principal Investigator on a screening trial for atrial fibrillation. AF has a five-fold increase in the risk of stroke. A major care gap in stroke prevention is the prevalence of undetected AF. “Through a clinical trial, we aim to determine if extended cardiac monitoring using external wearable monitors results in increased AF detection in high-risk individuals,” he says.

Dr Waters is working with a medical team in the Institute for Clinical Trials in Galway.

Philip Watt, CEO, Cystic Fibrosis Ireland Philip Watt has been elected President of Cystic Fibrosis Europe (CFE) for a term of 2 years. CFE is the Europe-wide network of CF patient groups based in Brussels. CFE has 39 member countries, including Ireland, with member countries ranging from the Ukraine to the UK. Total membership covers around 55,000 people.

Philip will be working closely with CEO Hilde De Keyser; Vice-President and PwCF Audrey Chansard (France); Treasurer Stefan Joris (Belgium) and all the Board members. This is an honorary/unpaid position. Some of the key issues will be improved and greater equality in access to medicines; supporting research and helping shape standards of care across Europe (through consensus).

Mr Kieron White, Postdoctoral Researcher, Physiology and Medical Physics, Royal College of Surgeons in Ireland Mr White is one of the first authors from the RCSI Precision Cancer Medicine Group working with Principal Investigator Professor Annette Byrne on a study which has discovered hree new subtypes of glioblastoma brain tumour which, with further investigation, could offer new hope in the form of much-needed effective therapies and improved outcomes for patients.

This discovery is particularly impactful because currently, most patients with glioblastoma are treated in the same way. Further investigation of these newly identified subtypes will mean that different patients could receive treatment specific to the cells in their own tumour, a concept known as 'precision medicine'.

L e g a l C a t e g o r y : S1A . M a r ke t i n g A u t h o r i s a t i o n H o l d e r : Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to PP-CIB-IRL-0140 report adverse reactions.

Date of preparation: October 2023

Professional 100 Professor William Wijins, SFI Professor of Interventional Cardiology, National University of Ireland Professor Wijins has been awarded ¤4.4million for the SMARTSHAPE project to focus on developing an implantable medical device for continuous blood pressure monitoring.

Hypertension is the leading global contributor to premature death, accounting for more than 9 million deaths a year. Elevated blood pressure is a chronic lifetime risk factor that can lead to serious cardiovascular events if undiagnosed or poorly controlled. Many high-risk patients require long-term monitoring to tailor drug treatments and improve healthcare outcomes, but there is no clinically accepted method of continuous beat-to-beat blood pressure monitoring that patients can use outside of the hospital setting.

Professor Leonie Young, Professor of Surgery/Lead, Endocrine Oncology Research Group, Royal College of Surgeons in Ireland Professor Young is the Principal Investigator of a study which has discovered key molecular changes that drive the spread of breast cancer to the brain.

Her research findings also identified potential new approaches to treating advanced breast cancer in the future.

With the support of Breast Cancer Ireland ambassadors, Professor Young and colleagues focused on breast cancer brain metastases, where an original cancer in the breast establishes secondary tumours in the brain.

Research for new ways to treat metastatic brain disease has tended to focus on changes in the DNA of cancerous cells, but Prof. Young took a different approach. She and her collaborators looked at changes in RNA, a type of molecule that helps to control how genes work.

Professor Dimitrios Zevgolis, Director, Regenerative, Modular & Developmental Engineering Laboratory, University College Dublin Professor Zevgolis has been awarded a coveted European Research Council (ERC) ’Proof of Concept’ grant to further his investigation into macromolecular crowding in cell cultures, and its use in regenerative medicine.

Professor Zevgolis was one of three Irish academics among 66 new grantees of the European grant, which aims to help researchers explore the commercial and societal potential of their research. The grants, worth ¤150,000, bridge the gap between discoveries stemming from frontier research and the practical application of the findings, and are made available as part of the European Union’s research and innovation programme, Horizon Europe.

Director of the Regenerative, Modular & Developmental Engineering Laboratory (REMODEL) at University College Dublin, Professor Zevgolis’s ERC Proof of Concept project ‘DECIPHER - Decellularised Extracellular Carpets for the Innovative Production of Human Engineered Replicates’ builds on a ERC Consolidator Award he received in 2019.

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

90 NSCLC

Immunotherapy through the Lens of Non-Small Cell Lung Cancer Written by Robyn Stanley1,†, Saoirse Flanagan1,†, David O’ Reilly2, Ella Kearney1, Jarushka Naidoo2,3,4,*,‡ and Catríona M. Dowling1,3,* School of Medicine, University of Limerick, V94 T9PX Limerick, Ireland

1

Beaumont Hospital, D09 V2N0 Dublin, Ireland

2

Department of Medicine, Royal College of Surgeons in Ireland, D02 YN77 Dublin, Ireland

3

Sidney Kimmel Comprehensive Cancer Centre, Johns Hopkins University, Baltimore, MD 21218, USA

4

*Authors to whom correspondence should be addressed.

These authors contributed equally to this work.

†

These authors also contributed equally to this work.

‡

Jarushka Naidoo

MODES OF ACTION FOR IMMUNOTHERAPIES Immune Checkpoint Blockade Inhibitors (ICIs) The development of immune checkpoint inhibitors (ICIs) has earned much interest in the field of immuno-oncology due to their significant success, in particular with improved survival in patients with difficult-to-treat cancers such as NSCLC.1 A key function of the immune system is to distinguish self from nonself. This is achieved by the detection and binding of a T cell receptor (TCR) to an antigen displayed by the major histocompatibility complex (MHC) on the surface of an antigenpresenting cell (APC).2 T cell activation is regulated by several immune checkpoint pathways during the immune response, a process called peripheral tolerance.2 At the centre of

this process are the cytotoxic T-lymphocytes-associated antigen 4 (CTLA-4) and programmed death 1 (PD-1) immune checkpoint pathways. Cancer cells have the ability to avoid immune suppression by expressing checkpoint molecules such as PD1, CTLA4 and programmed death ligand 1 (PD-L1).3 PD-1 is a member of the CD28 family of negative costimulatory receptors expressed on activated lymphocytes and monocytes. It modifies T cell activation by binding to its ligands presented on APCs, i.e., PD-L1 and programmed death 2 (PD-L2). PD-1 plays an immunoregulatory role by reducing initial T cell activation, modifying T cell differentiation and effector functions, and supporting the development of immunological memory.2 PD-L1 is expressed on tumour cells, and when it binds to PD-1 on the T cell, T cellassociated kinases are inhibited,

preventing the development of cytotoxic T cell response to tumours,4 thus stopping T cells from identifying and eradicating tumour cells (Figure 1). Moreover, binding to PD-L1 can inhibit the proliferation of T lymphocytes and the production of cytokines such as IL-2 and IFN-Y, thus inhibiting the proliferation of B lymphocytes.4 This results in an overall weakening of the immune response. High expression of PD-L1 is observed in 24–60% of patients with non-small cell lung cancer (NSCLC),5 and this high expression of PD-L1 has been shown to result in a shorter survival and a poor prognosis for patients.4 The expression of PD-L1 is controlled by a number of factors such as transcriptional regulation,6,7,8 epigenetic regulation,9,10 post-translational modifications11,12,13 and metabolic reprogramming.14,15,16 Monoclonal antibodies which bind and block PD-1 receptors signals can

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

reactivate the tumour-infiltering lymphocytes, allowing the recognition and elimination of malignant cells.17 TLA-4 is a receptor on T cells that causes the inhibition of T cell priming, activation, and migration.18 CTLA-4 is highly expressed on activated T cells where it competes with CD28 for binding to CD80 and CD86 expressed on APC (Figure 1).19 Consequently, the overexpression of CTLA-4 in the tumour micro-environment can act as a biomarker for prognosis and treatment of NSCLC.20 Targeting CTLA-4 can prevent the immunosuppressive CTLA-4 binding mechanisms by diminishing the co-stimulatory binding of CD28. This allows for the activation and proliferation of T cells at early stages prior to complementary ligand binding, leading to stimulatory signals which attack cancer cells.2 Currently six mAb targeting PD-1/ PD-L1 and one mAb targeting CTLA4 have been approved by the FDA for the treatment of NSCLC (Table 1), which we will discuss in more depth in subsequent sections.

There are also several other negative checkpoints emerging that suppress the immune system through ligand/receptor binding. These include T cell immunoglobulin, mucin-containing protein-3 (TIM-3), V-domain immunoglobulin suppressor of T cell activation (VISTA), ITIM domain T cell immunoreceptor (TIGIT), and Lymphocyte activation gene-3 (LAG-3).30 TIM-3 is expressed on activated CD4+ T cells (T helper cells) and negatively induces cytokines (Th1 and Th17). It also attaches to galectin-9, which leads

91 Figure 1. Mechanisms of action of immune checkpoint inhibitors. T cells recognize tumour antigens at the MHC on antigen presenting cells (APC) by T cell receptors (TCR) displayed on T cells. The interaction between CD80/CD86 (also known as B7-1 or B7-2) on APC and CD28 mediates a T cell co-stimulation in conjugation with TCR signals emitted by the T cell. CTLA-4 on activated T cells interacts with either CD80 or CD86 ligands (with a higher affinity for CD28), thus stopping the T cell from sending inhibitory signal to a T cells. Monoclonal antibodies, anti-CTLA-4 (e.g., ipilimumab) block this inhibitory pathway, thereby restoring T cell activity and amplifying an immune response. Cytotoxic CD8+ specific T cells recognise tumour antigens at the MHC of the APC using TCR. PD-1 is expressed on activated T cells, and the binding of PD-L1 on APC to PD-1 results in an adaptive expression. The interaction between PD-1 and PD-L1 negatively regulates the anti-tumour T cell response and causes immunosuppression. Anti-PD-1 (e.g., pembrolizumab) and anti-PD-L1 mAbs (e.g., atezoliumab) block this inhibitory pathway, thereby restoring T cell activity and relieving the immunosuppression.

to apoptosis of cytotoxic cells (CD4+ and CD8+).31 Galectin-9 is upregulated in cancer cells and suppresses an anti-tumour response through ligation with TIM-3.31 LAG-3 can also bind to galactin 3 in the TME, resulting in a reduction in anti-tumour response by inhibiting CD8+ T cells.32 TIGIT inhibits the immune system by competing with CD226 to interact with CD112 and CD155 which would normally activate T cells.33 VISTA is a member of the B7 family of checkpoints that are primarily expressed in hematopoietic cells and naïve CD4+ and Foxp3+ regulatory T cells. It can act as both a ligand and a receptor in negatively regulating immune responses.34 VISTA has been shown to be more complicated than originally

thought and its mechanism of action is not fully understood.

Some new studies have suggested a dual combination of ICIs may prevent resistance and improve positive outcomes for patients; however, elevated side effects must be considered.30 Patients who do respond to ICIs show that tumour load, immunogenicity, and the extent of immunosuppression in the microenvironment are critical factors that determine the probability of a positive clinical response.35 Thus, ICI combination strategies could be the way forward. Dual regimes including anti-PD-1 in combination with less successful ICI such as anti-TIGIT and anti-LAG-3 are currently in clinical trials.35 For example in the CITYSCAPE trial, atezolizumab (anti-PD-L1) plus tiragolumab (anti-

TIGIT) are being assessed for firstline treatment of NSCLC.36 Findings from this study have demonstrated that titragolumab plus atezolizumab improved both the response rate and progression free survival compared with atezolizumab alone with a safe profile.36 Other combination strategies involving ICIs and other forms of immunotherapy include the use of adoptive cell transfer with ICIs. The most recent of which includes the use of nivolumab in combination with tumour infiltrating lymphocytes (TIL). A phase 1 clinical trial investigating the benefit of TILs administrated with nivolumab in patients with advanced NSCLC demonstrated effective T cell expansion in vivo and manageable toxicity to the patient,37 showing promise for the future.

CAR-T Cell Therapy Another type of immunotherapy which has gained some attention in the lung cancer field is chimeric antigen receptor (CAR) T cells.

CAR-T cells are T cells that have been genetically-modified to express the CAR protein, allowing T cells to recognize cancer cells, without relying on MHC,38 and trigger a downstream signalling cascade of T cell activation.39 CAR-T cell therapy is an approved therapy for haematologic malignancies such as B-cell leukaemia.40 Many studies have displayed successful anti-tumour activity in vitro41 and in vivo42 using CAR-T cells specific to NSCLC tumour-associated antigens such as B7-H3,41 GD242 and PTK7.43 These studies and others have led to the development of clinical

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

92 NSCLC Table 1. Immune checkpoint inhibitors approved for the treatment of NSCLC. Name

Approval

Type of MA

Action

Usage

Reference

Nivolumab

March 2015

IgG4

PD-1

Stage III OR IV metastatic NSCLC.

[21]

Pembrolizumab

October 2016

Humanized IgG4-K isotope antibody.

PD-1

Stage IV metastatic NSCLC.

[22,23]

Atezolizumab

October 2016

IgG1

PD-L1

Stage III or IV metastatic NSCLC.

[24,25]

Durvalumab

February 2018

IgG1 k

PD-L1

Stage III NSCLC

[26]

Ipilimumab

May 2020 (in combination with nivolumab)

IgG1

CTLA4

NSCLC

[27]

Cemiplimab

November 2022 (in combination with platinum-based chemotherapy)

IgG4

PD-L1

Stage III OR IV metastatic NSCLC

[28]

Tremelimumab

November 2022 (in combination with durvalumab and platinumbased chemotherapy)

IgG2

PD-L1

Stage III OR IV metastatic NSCLC

[29]

Table 1. Immune checkpoint inhibitors approved for the treatment of NSCLC

trials of CAR-T cell therapy in NSC. However, these trials are still in early phase and are yet to receive FDA approval. Current issues in using CAR-T cells to treat solid tumours include the harsh tumour microenvironment,44 resulting in T cell exhaustion and subsequent failure to activate their cytotoxic abilities. T cells are also unable to detect intracellular antigens,44 and most significantly, there has yet to be a surface antigen discovered that is as widely expressed as CD19 on B-cells seen in leukaemia.45 Oncolytic Virus Therapy Oncolytic viruses are genetically modified to promote the targeting and destruction of specific cancer cells, while leaving selfcells untouched.46 The genetic modifications used in oncolytic virus therapy (OVT) remove the adenoviral genes that are used in normal cells for viral infection, but not in cancer cells.47 The primary mechanisms of oncolytic viruses include the lysis of tumour cells, followed by the promotion of anti-tumour activity,48 and changes in cytokine levels which generate a proinflammatory tumour microenvironment.49 Studies have also shown the ability of OVT to promote expression of PD-L1 on tumour cells, making them better targets for ICIs.50 OVT was first approved by the FDA as a treatment for unresectable melanoma patients in 2015,51 and there are ongoing trials examining the use of OVT in NSCLC patients (Table 3). A phase I study demonstrated the successful insertion of these oncolytic viruses into NSCLC cells while avoiding healthy tissue, and no adverse

reactions were reported.49 The study assessed intravenous delivery (IV) of enadenotucirev (ColoAd1) in patients with resectable colorectal cancer, nonsmall cell lung cancer, urothelial cell cancer and renal cell cancer patients. Immunohistochemistry (IHC) analysis was utilised to investigate the success of IV delivery of the virus, and successful viral replication was observed, demonstrating effective delivery of the virus. Positive CD8+ T cell infiltration was also observed in patients’ tumour samples, indicating viral delivery can induce a successful immune response without causing any harm to the patient.49 While the use of OVT remains very much at its infancy in the NSCLC setting, it will be interesting to see how this develops in the future.

Immunotherapy for Advanced Stage NSCLC In 2012, a phase I study was conducted to determine the safety and efficacy of nivolumab in patients with certain types of cancers. Surprisingly, this trial showed a response rate of 18% among patients with NSCLC and led to further clinical development and other anti-PD(L)1 agents in NSCLC.52 Checkmate-017 was a landmark phase III trial that examined the safety and efficiency of nivolumab versus docetaxel.

The trial showed significantly improved overall survival (OS), overall response rate (ORR), and progression-free survival (PFS) with nivolumab over docetaxel in patients who had received one prior line of therapy.21 In March 2015, Checkmate-017 together with Checkmate-057, which had the same study design

but was conducted in patients with non-squamous NSCLC,53 led to the approval by the FDA of nivolumab as the first ICI for the treatment of patients with advanced NSCLC after platinumbased chemotherapy. The five year outcomes of pooled data from both these trials revealed that at five years, nivolumab continued to demonstrate a survival benefit compared with docetaxel, with an OS of 13.4% versus 2.6%, and a PFS of 8.0% versus 0%.54 This is a significant and life-changing advance for patients with NSCLC. The approval of nivolumab was quickly followed by the approval of subsequent ICIs (Table 1). In October 2016, results from the KEYNOTE-01023 and KEYNOTE-02422 trials led to the approval of the PD-1 inhibitor, pembrolizumab, for the treatment of patients with metastatic NSCLC. In KEYNOTE-024, pembrolizumab was compared with cytotoxic chemotherapy as a first-line treatment for patients with advanced NSCLC and a PD-L1 tumour percentage score of 50% or greater. Pembrolizumab was shown to have significantly longer PS and OS and fewer adverse effects compared with platinumbased chemotherapy and so became a new standard of care for the first-line treatment of patients with ‘PD-L1 high’ NSCLC.22 Following positive results from the POPLAR and OAK trials, another ICI inhibitor, atezolizumab, was approved for second-line treatment for patients with locally advanced or metastatic NSCLC.24,25 While anti-PD-(L)1 monotherapy had demonstrated benefit in a subset of patients with pre-treated NSCLC, it was

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

also postulated that combination immunotherapy may be a useful strategy in NSCLC. Ipilimumab and tremelimumab are CTLA-4 inhibitors previously used in metastatic melanoma.

In a phase II trial conducted more than 10 years ago, single agent ipilimumab combined with chemotherapy demonstrated modest benefit compared with ipilimumab monotherapy in NSCLC.55 However, the combination of ipilimumab and nivolumab had demonstrated deep and durable responses in patients with melanoma,56 and it was hoped this could be recapitulated in NSCLC. In early phase studies of this combination, it was clear that the doses used for melanoma resulted in unacceptable toxicity in patients with NSCLC. After modification of this dose to ipilimumab every 6 weeks, the Checkmate-227 explored this combination in a complex eight-arm clinical trial.

Broadly, this study demonstrated a significant benefit in PFS and OS as well as durable responses in patients with both PD-L1 > 1% and PD-L1 < 1% NSCLCs, and is approved as a ‘chemotherapy-free’ option in the first-line treatment for patients with advanced PD-L1 > 1% NSCLC.27 In addition, a novel regimen from the Checkmate 9LA trial incorporating two doses of platinum-doublet chemotherapy in addition to ipilimumab and nivolumab also resulted in both PFS and OS benefits for this combination compared with chemotherapy alone, and is also an approved treatment option for first-line advanced NSCLC in all-comers for PD-L1 status.57 This regimen is thought to potentially

93 Table 3. Clinical trials investigating OVT in NSCLC. ClinicalTrials.gov Identifier

Status

Phase

Virus

Cancer Type

NCT03004183

Active, not recruiting

Phase II

ADV/HSV-tk

NSCLC

NCT05076760

Recruiting

Phase I

MEM-288

NSCLC

NCT02879760

Completed

Phase I/II

Ad-MAGEA3 and MG1MAGEA3

NSCLC

NCT02053220

Completed

Phase I

Colo-Ad1

NSCLC

NCT05602792

Recruiting

Phase I/II

T3011

NSCLC

NCT00861627

Completed

Phase II

REOLYSIN®

NSCLC

NCT03767348

Recruiting

Phase II

RP1

NSCLC

NCT04725331

Recruiting

Phase I/II

BT-001

NSCLC

Table 3. Clinical trials investigating OVT in NSCLC

provide the ‘neoantigen release’ of cytotoxic chemotherapy alongside the long-term durable outcomes seen with ipilimumab and nivolumab.

While the use of ICIs has undoubtably changed the landscape of patient care for NSCLC, there remains an urgent need to transform more patients from immunotherapy nonresponders to responders. Hence, current research strategies are focused on improving the response rate of ICIs, and these efforts are mainly centred around creating effective combination regimens with chemotherapy, radiotherapy, and other anti-cancer drugs. In 2018, the FDA approved the use of pembrolizumab in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC, independent of PD-L1 tumour expression status.

This approval was based on the results of the KEYNOTE-189 trial which demonstrated a longer OS and PFS in patients receiving pembrolizumab in addition to standard chemotherapy of pemetrexed and a platinumbased drug compared with patients receiving chemotherapy alone.58 This combination regimen was also approved for first-line treatment in metastatic squamous NSCLC following the results of

the KEYNOTE-407 trial, again independent of PD-LI tumour expression status.59 The positive results from the Impower150 trial led to the approval of atezolizumab with chemotherapy and bevacizumab for first-line treatment of metastatic nonsquamous NSCLC.60 Interestingly, it has been demonstrated that the combination of chemotherapy with bevacizumab induces proliferation of peripheral CD8 T cells, particularly memory and effector subsets,61 perhaps offering the rationale for combining chemotherapy and bevacizumab with ICIs. This is also now an approved option for first-line treatment of advanced NSCLC independent of PD-L1 status, based on the phase III IMPower150 trial.60 Immunotherapy and immunotherapy combination strategies are now an accepted standard of care, with 5-year survival data supporting these approaches. The future of immunotherapy research in this disease setting will focus on improving treatment for subsets for patients with advanced disease, developing approaches for the PD-L1 pre-treated setting, and conducting biomarker discovery of the mechanisms of response and resistance.

Immunotherapy in the Treatment of Earlier Stage NSCLC While immunotherapy has changed the management of advanced NSCLC, its use in early-stage NSCLC has only begun to emerge. In February 2018, the FDA approved the use of durvalumab for patients with unresectable stage III NSCLC whose disease had not progressed following concurrent platinumbased chemotherapy and radiation therapy. This was the first approval of an immunotherapy agent for the treatment of earlier stage NSCLC and was based on the results of the phase III PACIFIC trial, which demonstrated prolonged PFS and OS in patients treated with 1 year of consolidation durvalumab versus a placebo.26 In recent years, much effort has also centred around designing effective uses of immunotherapy for the treatment of resectable NSCLC. In October 2021, the FDA approved atezolizumab for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II and IIIA NSCLC whose tumours have a PD-L1 expression of greater than/equal 1% of tumour cells. This approval came about following the Impower010 trial which demonstrated a DFS benefit with atezolizumab

versus best supportive care after adjuvant chemotherapy.102 This was the first phase III trial to demonstrate a benefit from immunotherapy in patients with early-stage resectable NSCLC. In 2023, the KEYNOTE-091/PEARLS trial investigated pembrolizumab for adjuvant treatment of earlystage NSCLC following resection and optional platinum-based chemotherapy for patients with stage IB-IIIA NSCLC. This is approved for this indication, independent of tumoural PD-L1 expression.103 We have also recently witnessed the use of immunotherapy in the neoadjuvant setting for NSCLC. The Checkmate-816 trial was a phase III trial examining the use of nivolumab plus platinumbased chemotherapy versus chemotherapy alone, followed by resection in patients with stage IB to IIIA resectable NSCLC; patients were enrolled regardless of PD-L1 status.112 The results demonstrated that nivolumab plus chemotherapy resulted in significantly longer event-free survival and a higher percentage of patients with a pathological complete response than chemotherapy alone. Similar results have also been observed in the NADIM trial, for patients with resectable stage IIIA NSCLC.113 The trial compares the effect of

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

94 NSCLC nivolumab with chemotherapy against chemotherapy as a monotherapy. While the trial is still ongoing, current results show an improved overall survival in patients treated with chemoimmunotherapy compared with chemotherapy alone, with overall survival at 24 months showing 85.3% vs. 64.8%.

In March 2022, the Checkmate-816 data led to the FDA approval of neoadjuvant nivolumab and platinum-doublet chemotherapy for the treatment of early-stage resectable NSCLC. The NEOSTAR trial was also performed in the neoadjuvant setting, examining the effect of nivolumab or nivolumab and ipilimumab followed by surgery in patients with resectable NSCLC. The data from this trial indicate that neoadjuvant nivolumab and ipilimumab-based therapy enhances pathological response, tumour immune infiltrates and immunological memory.111 For patients with resectable NSCLC, the goal of therapy is cure. In the context of a curable disease, ICIs are used to reduce the risk of relapse, but it is critical that they do not interfere with the curative portion of the treatment paradigm, that is, surgery. This is a particular challenge for patients being treated in the neoadjuvant setting (e.g., CHECKMATE-816) in which the use of neoadjuvant therapy could be associated with delays to surgery.

Encouragingly, an increased risk of surgical complications has not been observed in most neoadjuvant studies involving ICIs and NSCLC. For example, in the CHECKMATE-816 study, the authors reported surgical complications of 41.6% in the nivolumab plus chemotherapy arm and 46.7% in the chemotherapy arm.116 Encouragingly, only 3.4% of patients had delayed surgery in the nivolumab plus chemotherapy arm and 5.1% in the chemotherapy alone arm.

For patients in the adjuvant setting (e.g., PEARLS/ IMPower010), different challenges emerge compared with the neoadjuvant setting.102,117 Given that the cancer is already surgically resected, irAEs will not interfere with patients’ curative procedure. However, unlike in the metastatic setting, it is our expectation that the majority of these patients will be cured of their disease. In this regard, the risk of inducing a chronic or multiorgan toxicity may be associated with significant and long-term

impact on patients’ quality-of-life.

The risks and benefits of such adjuvant therapy pose challenges in weighing the low risk of longterm toxicity versus the survival benefit of disease control.

Decisions regarding the most appropriate treatment option need to be made in a collaborative manner between patients and the multidisciplinary team.

Adjuvant/neoadjuvant studies in resectable NSCLC have to date demonstrated impressive event-free/disease-free survival for patients, which we hope will translate to an overall survival benefit. Long-term follow-up and further studies will provide more data on the efficacy of adjuvant/ neoadjuvant ICI and the risks of delays to surgical resection/longterm toxicity. We eagerly await the publication of further studies in this field and long-term follow-up.

CHALLENGES ASSOCIATED WITH THE USE OF IMMUNOTHERAPY Immune-Related Adverse Events (irAEs) Despite the clinical benefit that arises from immunotherapy, more than 20% of patients experience immune-related adverse events (irAEs) from therapy, and the incidence may be >50% with combination approaches.118 Immune-related adverse events can be described as autoimmune conditions that can affect any organ system in the body after ICI administration.119 These toxicities have presented as a challenge for clinical practitioners and patients because rather than managing familiar side effects such as nausea, anaemia, and immunosuppression, they are now confronted with unfamiliar side effects, such as underactive pituitary glands and hepatitis.119 Immune-related adverse events vary in terms of their onset time, severity, and underlying biology.120 They can affect a broad range of organs and occur at any time during the patient’s treatment course. They most commonly occur in the first three months of treatment but have also been observed to occur long after ICI has been stopped.121 The time of irAEs occurrence gives an indication of the severity of the effects on the patient. For example, toxicity in the first year of therapy strongly correlated with long term toxicity beyond 1 year.120 Many ICI clinical trials have reported longer-term safety data, but information is still limited about the ongoing impact of the toxicities.121 Treatments for irAEs

centre around glucocorticoids for acute irAEs (developed during ICI treatment) specifically, with good effects observed after several weeks. Although most irAEs resolve, some develop into a chronic state (develop after ICI treatment has terminated) and lifelong therapy such as hormonal supplementation or immunosuppression may be required.119 IrAEs are distinct from those that occur with traditional chemotherapy or other forms of anti-cancer therapy as they occur as a result of the immunologic mode of action of ICIs. There are limited data exploring the mechanisms that underpin the development of irAEs. However, T-cell,122,123,124 B-cell125 and macrophagerelated mechanisms123 have been identified. In a comprehensive clinical and translational study, the cytokine interleukins-6 (IL-6) was shown to be highly upregulated in the patient cohort after nivolumab treatment.124 Moreover, blocking IL-6 in mouse models could potentially mitigate autoimmunity and maintain, or even possibly boost, the tumour immunity.124 Recently, it was observed that the use of IL-6 blockade in a patient with ICI-induced irAEs led to successful mitigation of irAEs symptoms without compromising the ICI treatment.124 It has been demonstrated that changes in T cell populations occur early after ICI treatment,122 and these changes can also affect B cells and macrophages directly or indirectly; however, the mechanism for this remains largely unknown.125 Early changes in B cells have also correlated with high rates of irAEs, indicating B cells may play an important role in driving irAEs.125 The link between T cells, B cells, and macrophages in relation to irAEs and the modes of actions they employ, is of major interest of the immunotherapy field at present.

It is critical that effective strategies are developed in the clinic to address the issue of irAEs associated with ICIs. Clinical experience of ICI toxicity develops local expertise in managing the diverse range of potential irAEs associated with ICIs. In recent years, there has been the publication of international guidelines for the management of irAEs to guide clinicians in the clinical management of these complex cases. These include the National Comprehensive Cancer Network (NCCN) and the European Society of Medical Oncology (ESMO) guidelines.126,127

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

These provide detailed decision assistance tools regarding risk stratification, early diagnosis, steroid administration and steroid sparing strategies for patients experiencing irAEs. The management of irAEs ideally involves specialist teams involving a medical oncologist and an organ specialist (e.g., a respiratory physician in case of pneumonitis).

In some institutions, this has been formalised into a dedicated irAE toxicity team. This form of multidisciplinary team has demonstrated feasibility and been shown to change patient management.128 Critical areas of research include the appropriate risk stratification of patients and the development of biomarkers for early identification of irAEs. Prior to treatment initiation, risk stratification of those at high risk of irAEs is a critical step in ensuring patients are not exposed to an unacceptable level of risk. For example, it has been demonstrated that patients with a history of interstitial lung disease are at high-risk of developing ICI associated pneumonitis.129 In the case of cardiotoxicity, prospective data would suggest that baseline ECG/troponin can be helpful in identifying those patients most at risk of toxicity, and these patients may warrant close surveillance.

It is likely that the future of ICI toxicity management will involve a refinement of our strategies to identify those patients most at risk through clinical studies and biomarker identification in tandem with improvements in immunosuppressive strategies.

Biomarkers The reasons underlying why some patients with NSCLC achieve disease control from therapy, or develop toxicity, are incompletely understood. Hence, another major challenge facing the modern era of immunotherapy treatment lies in the development of efficient biomarkers to optimize patient selection. The expression of PD-L1 on tumour cells, quantified using IHC, is currently the most widely used and validated biomarker to guide the selection of patients to receive ICIs. PD-L1 expression has shown predictive value in many clinical trials in NSCLC, with correlations observed between clinical response and increased expression of PD-L1 on tumour cells.23,24,130,131 However, positive correlation of PD-L1 expression can only partially predict which patients will benefit from ICIs, and many trials have demonstrated responses irrespective of PD-

95 L1 expression status.5,21 This imperfection in the use PD-L1 as a biomarker of response could be attributed to many factors.

For instance, differences exist in the specific types of assays that are utilized to assess PD-L1 expression in tumour tissues, and even within these assays it can prove difficult to score the PD-L1 expression consistently and accurately on tumour cells and immune cells.132 Moreover, intratumour heterogeneity (ITH) exists within the tumour of patients with NSCLC, and hence, the biopsy samples may not accurately reflect the expression of PD-L1 throughout the tumour.133,134 The emerging use of liquid biopsies to assess the expression of PDL1 using cytology samples has shown great promise, and so may help overcome some of these challenges in the future.39 Tumour mutational burden (TMB) refers to the absolute number of non-synonymous mutations within a tumour, which leads to the generation of immunogenic neo-peptides displayed on the surface of tumour cells, and hence, is associated with a greater CD8+ T cell response following ICI treatment.135 In June 2020, the FDA approved the use of pembrolizumab for the treatment of unresectable and metastatic solid tumours with a high TMB. This approval was based on the results of the KEYNOTE-158 trial which demonstrated that a high TMB was associated with an increased objective response rate.136 However, similar to the use of PD-L1 expression, the predictive value of TMB is limited by the presence of ITH. A high ITH may result in the neoantigens only being present on a subset of cells and hence, the immune response may not be effective against the entire tumour.137 Moreover, sub-clonal neoantigens, which occur as a result of cytotoxicchemotherapy, give rise to high TMB and these sub-clonal neoantigens are associated with poor responders. This is

in comparison to an enhanced response to ICI in patients with tumours enriched for clonal neoantigens.138 Hence, neoantigen ITH can also contribute to the limited predictive value of TMB, emphasizing the need for effective diagnostic techniques that examine the entire tumour.

Another biomarker of response which is currently gaining much attention in the field of NSCLC is the use of circulating tumour DNA (ctDNA). Cells release small double-stranded DNA fragments into the bloodstream during apoptosis and necrosis, termed circulating free DNA (cfDNA), and in cancer patients, small fractions of cfDNA can be shed from the tumour in the form of ctDNA.139 Several studies have demonstrated that the levels of ctDNA, as detected by a liquid biopsy, can predict response to ICI in patients with NSCLC.140,141,142 Moreover, ctDNA can be used for the detection of point mutations associated with sensitivity to ICI. For example, several studies have demonstrated that mutations in STK11 can predict the response to treatment,143 including ICIs144 in NSCLC. Other biomarkers assessed by liquid biopsy which may offer potential in predicting the response to ICI in the future include peripheral blood cytokines,145 circulating non-coding RNA146 and the levels of various immune cell populations.147,148,149 Finally, biomarkers to predict irAEs are even less characterised.

Some research suggests the composition of the gut microbiome in response to ICI can influence the development of irAEs;150,151 however, the mechanism of action remains largely unclear. Other potential irAEs biomarkers include baseline auto-antibodies,152 germline genetics,153 T cell and B cell populations,133 and shared T cell antigens.132 Given the adverse effects that ICI can have on patients, it is imperative that the field invests research in developing predictive biomarkers

to optimise patient selection and deliver this therapy to patients most likely to benefit.

Future Outlook for the Use of Immunotherapy in NSCLC ICIs have established efficacy in advanced and early-stage NSCLC, and it is unlikely that PD-1/PD-L1 monotherapy will improve on the already established benefit for patients. As mentioned previously in this review, recent interest lies in combining ICIs with novel combination strategies which could include radiation, novel ICIs or other novel systemic therapies.

For example, neoadjuvant durvalumab was investigated with or without sub-ablative stereotactic radiotherapy (SBRT) in patients with resectable NSCLC.154 In this study patients received two cycles of neoadjuvant durvalumab +/− 3 fractions of SBRT (8 Gy * 3), followed by surgery. In the NEOCOAST study, the authors investigated neoadjuvant durvalumab +/− novel agents for resectable stage I–IIIA NSCLC.155 These novel agents included the anti-CD73 agent oleclumab, the anti-NKG2A monalizumab or the anti-STAT3 antisense oligonucleotide danavatirsen.

Finally, the inhibition of novel checkpoints as a monotherapy or in combination with pre-existing ICIs is an emerging strategy in this field. LAG-3 suppresses T cell activation and cytokine secretion.156 Inhibitors of LAG-3 have already reached phase II and phase III clinical trials and relatlimab has been approved in combination with nivolumab for advanced melanoma.157 In NSCLC, the RELATIVITY study has commenced accrual and is exploring the combination of relatlimab and nivolumab and chemotherapy in the advanced setting.158 Another critical area of research in this field is utilising ‘liquid biopsy’ assays to identify patients not responding to therapy at an early stage in their treatment paradigm so that therapy plans can be adapted thereafter. ‘Liquid

Biopsy’ generally refers to the use of blood based (but can use other body fluids, e.g., breath) biomarkers to identify tumourbased signatures which could include cfDNA, ctDNA, circulating tumour cells (CTCs) and others.159 In an investigation of 67 patients with stage IV NSCLC, a ctDNA ‘molecular response’ in plasma 9 weeks post starting ICI was associated with a durable clinical benefit (defined as an ongoing response at 6 months post IO, 3.5% vs. 49.4%, p < 0.001). This study demonstrates the potential for ctDNA dynamics to identify responders to therapy.

In summary, it is likely that the future of ICIs in NSCLC will involve their combination with other systemic/local therapy but advances in therapeutics will be combined with novel diagnostics/ biomarkers (e.g., liquid biopsy) to improve patient selection for therapy.

Conclusions The introduction of immunotherapy as a treatment option for patients with NSCLC has offered benefit and hope to selected patients. This is reflected in the survival benefit and improvements in the quality of life for these patients. However, the subset of patients who sustain a prolonged anti-tumour response remains relatively low. Continued development of effective immunotherapybased combination regimens and expansion into earlier stage NSCLC will hopefully increase the proportion of patients who respond to ICIs in the future.

Moreover, a critical gap in the field is to develop predictive biomarkers to identify patients who will benefit most from ICI or develop toxicity. The identification of such biomarkers and their integration with clinical care and therapeutic decision-making would continue to ensure the impact of immunotherapy for NSCLC in the future.

References available on request

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

96 Clinical R&D FONTERRA AND APC MICROBIOME IRELAND FORM NEW STRATEGIC PARTNERSHIP Fonterra, the New Zealand-based global dairy producer, and APC Microbiome Ireland (APC), a world-leading SFI Research Centre based at University College Cork (UCC), have announced that they have entered into a new strategic research partnership.

The partnership will focus on the human microbiome with a view to developing new probiotic products that have health and wellness benefits.

The project will entail the establishment of a new Fonterra microbiome research centre based in UCC to maximise the collaborative relationship with APC. It is expected to be operational before the end of 2023.

Mark Malone, General Manager for Science and Technology, commented: “This new partnership with APC is a fantastic opportunity for Fonterra to collaborate with world leading experts in the field of probiotics and microbiome research. This will augment Fonterra’s health and nutrition expertise and accelerate our development of new and differentiated nutritional offerings.”

Paul Ross, Director APC Microbiome Ireland, said: “This is a significant development for APC and we are thrilled to be working together with Fonterra. This latest collaboration with industry underlines APC’s reputation as a global leader in microbiome research and our expertise in supporting new product development with our Irish and international industry partners.”

Prof. John O’Halloran, President UCC; Dr. Shalome Bassett, Programme Leader Scientific Affairs, Fonterra; Dr. James Dekker, Platform Manager, Fonterra; Prof. John Cryan, VP Research & Innovation, UCC; Dr. Brendan Curran, General Manager, APC; Prof. Paul Ross, Director, APC

Professor John O’Halloran, UCC President, said: “This collaboration reinforces the commitment APC shares with Fonterra to develop new, evidence-based products that support lifelong health. It reflects UCC’s international reputation in science and innovation and is an important milestone in our UCC Futures – Food, Microbiome and Health strategy which aims to provide solutions to some of the most important challenges of our time.”

CARDIAC REHABILITATION PROVEN TO SIGNIFICANTLY REDUCE ILLNESS, HOSPITAL ADMISSIONS AND DEATH The HSE is launching new developments in cardiac rehabilitation, designed to save lives and significantly improve the quality of life for many thousands of patients with cardiovascular disease, while also treating people close to home.

Cardiac rehabilitation starts in hospital when a patient is admitted with an emergency cardiovascular event such as a heart attack or heart failure and is a process that continues for the patient upon discharge into the community and at home. It is a supervised programme designed to improve a patient’s cardiovascular health and to empower them with the knowledge and tools to manage their cardiovascular disease and to live well with their chronic condition. It includes education on risk factor management, heart healthy living and exercise, counselling and training. It is offered to people who have experienced a heart attack, angioplasty and heart surgery and to people with heart failure.

For people who have been hospitalised with cardiovascular disease, keeping well and preventing repeat events and hospitalisations is paramount.

Cardiac rehabilitation has consistently been demonstrated to significantly reduce illness, hospital admissions and death amongst patients with established cardiovascular disease, while

also increasing their quality of life.

Access to cardiac rehabilitation will be significantly improved (currently 40% of eligible patients are waiting for at least three months[1]) due to the significant additional resources that the HSE has funded to support increased patient choice in where and how they participate in cardiac rehabilitation.

This service is based on the Model of Care for Integrated Cardiac Rehabilitation and it is a major step forward. It will ensure that patients living with cardiovascular disease across the country have access to timely, high quality cardiac rehabilitation care, no matter where they live. It is an evidenced-based and cost-effective approach that helps patients to manage their own condition in partnership with their healthcare professionals. It has consistently been demonstrated to significantly reduce morbidity, hospitalisations and mortality among patients with established cardiovascular disease while also increasing their quality of life.

The model also places a focus on encouraging and supporting referral to, and attendance at, cardiac rehabilitation for those who are traditionally under-referred to cardiac rehabilitation, such as women, older patients and marginalised groups.

Professor J William McEvoy, Chair of the Prevention SubGroup of the National Heart Programme and Director of the National Institute for Prevention and Cardiovascular Health said; “The Model of Care for Integrated Cardiac Rehabilitation represents the culmination of years of hard work. It will support the provision of optimal care for patients living with chronic cardiovascular disease in Ireland. This model of care has been developed and refined by a wide range of stakeholders within the Irish healthcare system. I acknowledge the work of all involved to make this Model of Care available for patient care. In addition, as an internationally active researcher in preventive cardiology, I can confidently say that this Model of Care incorporates the latest and best in evidence-based medicine.

I see the publication as a further advance in improving timely access to and consistency of care for patients who require cardiac rehabilitation across the country.”

Professor Ken McDonald, HSE Clinical Lead, National Heart Programme said; “The Model sets out a robust cardiac rehabilitation service as part of an integrated framework for the prevention and management of chronic disease in Ireland, placing patients squarely at the centre of care. The cardiac rehabilitation service will be

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

planned around patients according to need; so as to support and empower them to optimise their health, actively address and minimise their risk factors for chronic disease, and to live well with chronic disease. The National Heart Programme endeavours to support cardiac rehabilitation professionals, as we work together to implement this.”

NEW RESEARCH REVEALS LINK BETWEEN CHILDHOOD MENTAL HEALTH PROBLEMS AND QUALITY OF LIFE FOR YOUNG ADULTS Children with mental health issues are more likely to have poor mental and physical health in their late teens and early 20s, and are at greater risk of social isolation, low educational attainment, financial difficulties and heavy substance use. That’s according to new research led by RCSI University of Medicine and Health Sciences, which examined a wide range of data from more than 5,000 children and young adults in Ireland.

The findings, published today in JAMA Network Open, are drawn from the ‘Growing up in Ireland’* study. The researchers from Ireland, the UK, and Australia followed trends of mental health throughout childhood (ages 9-13) for 5,141 people.

The vast majority (72.5%) of participants whose data were analysed reported no significant mental health difficulties, but more than 1,400 individuals appeared to have some type of mental health or behavioural issue across childhood.

“Mental health symptoms often come and go throughout childhood and adolescence, so we do not want to over-rely on symptom levels at one point in time. We decided to investigate children who had persistent reports of mental health symptoms, regardless of whether they met the criteria for an official diagnosis,” said study lead author Dr Niamh Dooley from the RCSI Department of Psychiatry.

The study looked at how these patterns of childhood mental health affected a range of outcomes in late adolescence and early 20s. The study took a broad approach to life outcomes, examining aspects such as Leaving Certificate results, social isolation and how often they used health services as young adults, poor physical health issues (e.g. obesity, sleep difficulties), heavy substance use (alcohol, smoking), and/or the young person’s general feelings of well-being.

Importantly, the researchers also took different types of childhood symptoms into account, such

97 as whether a child tended to internalise their symptoms (as in depression and anxiety), externalise their symptoms (as in hyperactivity and behavioural problems), or both.

The research found that children with externalising symptoms are at increased risk of heavy substance use as young adults. Children with internalising symptoms are at the highest risk of poor physical health in their late teens and early 20s.

“Our analysis shows that mental health problems in childhood are linked with a wide range of functional issues in adulthood, beyond the realms of mental health. And some groups were at particular risk for specific outcomes. For instance, females with persistent symptoms across childhood, particularly internalising symptoms, had very high rates of poor physical health by young adulthood,” said Dr Dooley.

The data also showed that those who had mental health issues in childhood were as likely to encounter educational/economic difficulties in young adulthood as they were to face further mental health problems.

“Over 50% of children with mental health issues had at least one educational or economic difficulty by young adulthood, compared to around 30% of those without mental health issues in childhood,” said Dr Dooley.

The findings point to the need for better screening and treatment of mental health problems in childhood and adolescence, which may prevent problems later on in life, according to study co-author Professor Mary Cannon, who is RCSI Professor of Psychiatric Epidemiology and Youth Mental Health.

SLIGO UNIVERSITY HOSPITAL DELIGHTED TO LAUNCH UPGRADED PAEDIATRIC FACILITATES Young patients attending the Paediatric Outpatients and Physiotherapy Departments in Sligo University Hospital (SUH) can enjoy renovated spaces which focus on stimulation and play.

The Paediatric Outpatient play area was re-designed recently to create a more relaxing environment for children who are waiting for their appointment. The waiting area upgrade was supported by NMPDU Innovation funding and features a large marine themed mural, with lots of toys, activity boards and distractions for our young patients.

The Paediatric Physiotherapy Department has also undergone a renovation with the installation of a new overhead mobile, relaxing music and light projector for the ceiling. These enhancements were made possible by generous donation from a local family whose daughter Maisie attends the Physiotherapy Department for treatment.

The Paediatric Physiotherapists at SUH assess and treat lots of babies and children with orthopaedic, musculoskeletal, respiratory or neurological conditions or developmental delay. Children can be seen for several follow-up appointments at the Physiotherapy clinic at regular intervals and the upgraded clinical space now offers a more comfortable and relaxing environment for patients to be treated.

Rachel Wirtz, Clinical Specialist Paediatric and Neonatal Physiotherapist led both projects in SUH and speaks about the methodology behind the upgrade works, “Play is essential to development and contributes to the cognitive, physical, social and emotional wellbeing of children.

These skills are paramount for child development and building blocks for their learning and ability to blossom within their environment.

“Many children need to attend our clinics for several appointments over many years so it is really important that we have a positive and relaxing environment available.

Nobody wants to spend time in hospital but in the Paediatric Department we aim to make appointments as enjoyable as possible so that children are happy to return and have positive association of their time in SUH.” Grainne Mc Cann, Hospital Manager in SUH added. “We have a very compassionate and caring Multi-disciplinary Paediatric team in the hospital and we hope that these types of improvements provide a more comfortable environment for children, attending our services, giving a better experience while in the hospital.

LATE-BREAKING AMLITELIMAB PHASE 2B DATA PRESENTED AT EADV SHOW POTENTIAL BESTIN-CLASS PROFILE IN ATOPIC DERMATITIS Positive results from a Phase 2b study (STREAM-AD) showed that amlitelimab significantly improved signs and symptoms of moderate-to-severe atopic

“Our study shows that mental health symptoms in childhood can cast a long-lasting shadow on adult life,” said Professor Cannon. “If we understand more about which children in the general population are at greatest risk of poor outcomes, it will help to inform and improve early screening and approaches to support those children.”

Professor Cannon is a member of a working group tasked with implementing the “Sharing the Vision” mental health policy recommendations, with a particular focus on improving transition of young people from child to adult mental health services.

The study was funded by the Health Research board through an Investigator Led Project to Professor Mary Cannon.

Georgina Kilcoyne, Assistant Manager SUH; Amanda Kilcullen, Paediatric Dietician; Helen McGinn, Senior Paediatric Physiotherapist; Niamh Walsh, CNM; Charlie Ward a young patient in SUH; Bernie Clancy, CNM3 Paediatrics; Helena Gibbons Staff Nurse; Dr Diego Hernandez, Consultant Paediatrician; Dr Suzan Mohammed Paediatric Registrar; Leighann Flynn, Clerical Administration; Louise Farren, Staff Nurse and Rachel Wirtz, Clinical Specialist Paediatric and Neonatal Physiotherapist.

dermatitis in adults whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach. These detailed results were presented today as part of a late-breaking session at the European Academy of Dermatology and Venereology (EADV) 2023 Congress in Berlin. The Phase 3 program for amlitelimab in atopic dermatitis is on track to start in the first half of 2024. This program is part of Sanofi’s immunology strategy built around exploring disruptive mechanisms of action designed to deliver first and best-in-class treatments for people living with chronic inflammatory diseases.

In this dose-ranging study, subcutaneous treatment with amlitelimab resulted in statistically significant improvements in the primary endpoint of percent change in Eczema Area and Severity Index (EASI) score from baseline at 16 weeks compared to placebo for all four doses that were studied. Among these, patients treated with amlitelimab 250 mg Q4W with 500 mg loading dose (LD) had the numerically highest response versus placebo, showing a 61.5% reduction in EASI from baseline at week 16 (P<0.0001) and a 64.4% reduction at week 24 (P<0.0001) vs. 29.4% at week 16 and 27.6% at week 24 for placebo.

Professor Stephan Weidinger, M.D, Ph.D, Director, Professor, Chair of Department of Dermatology and Allergy, University Hospital Schleswig-Holstein said, “These results are exciting news for patients with moderate-to-severe atopic dermatitis who continue to suffer from symptoms including persistent itch and skin lesions, despite available treatment options. Across all four doses studied, we saw consistent improvements in important signs and symptoms of the disease with an unremarkable safety profile.

These data also add to the growing body of evidence that targeting OX40-Ligand potentially stops the inflammatory cascade across multiple pathways resulting in significant benefit for patients.”

Across amlitelimab doses, clinically meaningful and nominally significant improvements were seen in all key secondary endpoints at weeks 16 and 24, including Investigator Global Assessment response of 0 (clear) or 1 (almost clear skin) (IGA 0/1), 75% reduction from baseline in EASI (EASI-75) and weekly average reduction of Peak Pruritus Numerical Rating Scale ≥4 points from baseline (PP-NRS ≥4), with the exception of the 250 mg (no LD) in IGA 0/1 at Week 16 (p=0.0562).

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

98 Clinical R&D 22.1% and 45.5% of patients treated with amlitelimab 250 mg with LD achieved IGA 0/1 at weeks 16 and 24, respectively, compared to 5.1% and 11.4% of placebo patients (P=0.0022 and P<0.0001). Of patients treated with that same dose, 40.3% and 54.5% achieved EASI-75 at weeks 16 and 24, respectively, versus 11.4% and 17.7% on placebo (both P<0.0001).

Across all doses at weeks 16 and 24, amlitelimab treatment substantially reduced levels of biomarkers elevated in atopic dermatitis, including Th2-related IL-13 and TARC, Th17/Th22-related IL-17A and IL-22, and blood eosinophil counts, with significant reduction observed as early as week 4 in the 250 mg with LD arm.

Amlitelimab was well-tolerated in the study across all dose arms and no new safety concerns were identified. The overall rates of treatment-emergent adverse events (TEAEs) were 67.4% for amlitelimab and 60.3% for placebo. TEAEs more commonly observed with amlitelimab compared to placebo included nasopharyngitis (11.0% amlitelimab, 9.0% placebo), COVID-19 (7.7% amlitelimab, 6.4% placebo) and headache (6.1% amlitelimab, 2.6% placebo).

Worsening of atopic dermatitis was more commonly observed with placebo compared to amlitelimab (38.5% placebo, 17.1% amlitelimab). No adverse events such as fever or chills, oral ulcers or imbalances with conjunctivitis were observed across doses.

Amlitelimab is a fully human nondepleting monoclonal antibody that binds to OX40-Ligand, a key immune regulator, and has the potential to be a first-inclass treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis and asthma. By targeting OX40-Ligand, amlitelimab aims to restore balance between proinflammatory and regulatory T cells.

Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

TILRAY MEDICAL SUPPORTS NEW CLINICAL TRIAL TO STUDY MEDICAL CANNABIS IN GLIOBLASTOMA CANCER TREATMENT Tilray Medical, a division of Tilray Brands, Inc. ("Tilray" or the "Company") (Nasdaq: TLRY; TSX: TLRY) and a global leader in medical cannabis, empowering the therapeutic alliance between patients and healthcare practitioners to make informed

individualized health decisions, transforming healthcare, have announced their contribution to an independent clinical trial to research the efficacy of medical cannabis as a treatment for glioblastoma, a severe form of brain cancer. The clinical trial will be conducted in Spain, recruiting 30 patients from eight specialized neuro-oncology medical sites, in partnership with renowned scientists from the Spanish Research Group of Neuro-Oncology (GEINO) and the Complutense University of Madrid, with Tilray Medical providing the pharmaceutical-grade medical cannabis for the trial (THC/CBD 1:1) for administration to patients.

The trial is funded by the Medical Cannabis Bike Tour Foundation charity and is scheduled to commence at University Hospital 12 de Octubre, on September 5, 2023.

Denise Faltischek, Tilray’s Chief Strategy Officer and Head of International Business, stated, "This groundbreaking trial is more than an opportunity for Tilray to engage in medical research; it's a beacon of hope for patients suffering from Glioblastoma. Our role in this initiative exemplifies our commitment to medical research, leading us one step closer to unlocking the full therapeutic potential of medical cannabis."

Led by esteemed coordinating investigator Dr. Juan Manuel Sepúlveda Sánchez from GEINO, the clinical trial is a Phase I, openlabel, multicenter, intrapatient dose-escalation to evaluate the safety and profile of Tilray Medical’s T10:C10 (THC+CBD) extract, in conjunction with temozolomide and radiotherapy for newly-diagnosed Glioblastoma patients.

While medical cannabis research has been an ongoing mission towards patient treatment, this trial is unique because it is the culmination of a 10-year civil society collaboration between the scientific sector and the medical cannabis community. According to Dr. Juan Sepulveda, “Biological evidence has been accumulating for more than 15 years that cannabinoids have anti-tumor activity in the most aggressive brain tumors, glioblastomas.

However, no clinical trials have been conducted to prove this hypothesis in patients. With this clinical trial, we can finally study the effect of cannabinoids on tumors that have not received active treatment. With this trial, we are helping to give our patients a new option, but also to open a therapeutic avenue. The trial is the result of a collaboration between civil society through the Medical Cannabis Bike Tour, an emerging pharmaceutical company and clinical scientists.”

In 2013, the Medical Cannabis Bike Tour began raising funds to support the work of the Complutense Madrid University team. Guided by Dr. Manuel Guzmán and Dr. Guillermo Velasco, the team at Cannabinoid Signalling Group was researching the effects of cannabinoids on cancer cells and the potential as a glioblastoma treatment. Today, with proceeds from the Medical Cannabis Bike Tour founded by Luc Krol from the Netherlandsbased cannabis genetics seed bank, Paradise Seeds, the Medical Bike Tour Foundation mobilized the European cannabis community. It attracted significant sponsorship from the industry over the course of five events held in different European countries who were advocates for the impact of medical cannabis and its benefits.

As a result, Luc Krol passionately adds, “The world was very different when we began the Medical Cannabis Bike Tour 10 years ago.

We believed in the outstanding work of doctors including Dr. Guzman and Velasco and their team and asked the cannabis community for their support. The fact that the Medical Cannabis Bike Tour can now independently fund a clinical trial in the name of science, is amazing thanks to the sponsors and riders who made it happen. We hope this trial will reflect the hope illuminated by the scientific research for the participants involved.”

with applications in disease research and the drug discovery process, at the UCD Conway Institute of Biomolecular and Biomedical Research at University College Dublin (UCD).

IRISH SME ANNOUNCES WORLD’S FIRST COMMERCIAL DEPLOYMENT OF NOVEL TABLE-TOP SOFT X-RAY MICROSCOPE

“The deployment of the SXT-100 at the UCD Conway Institute is an outstanding example of the University’s research and innovation intensive focus and on the emphasis we place on translating fundamental research outputs into innovative products, such as the SXT-100 microscope, which will lead to a greater understanding of health and

SiriusXT Ltd, an Irish technology SME, announced today the world’s first commercial deployment of the SXT-100, the company’s unique table-top Soft X-ray Microscope

Soft X-ray microscopy (SXM) is the only nanometre-resolution 3D imaging modality that is capable of imaging the whole internal structure of intact biological cells. It is used in disease and therapeutic research to help scientists to better understand disease causation and transmission mechanisms as well as to validate therapeutic effectiveness in the drug discovery process.

Until now, SXM has only been available at six worldwide (UK, Germany, Spain, USA, China and Taiwan) synchrotron facilities, which can typically be the size of several football pitches, with the capability of producing the soft X-ray illumination required for 3D imaging at the nanometre scale.

SiriusXT’s innovation, following years of research by the company’s co-founders at UCD, has been to miniaturise the soft X-ray illumination source to a small chamber that enables the construction of a table-top microscope.

This patented technological breakthrough now allows SXM to be deployed globally at thousands of disease and therapeutic research laboratories.

Pictured (l-r) at the UCD Conway Institute are; Professor Jeremy Simpson, Dean of Science and Principal, UCD College of Science, Dr Kenneth Fahy, co-founder and Vice-President for Product Management, SiriusXT and Dr Paul Sheridan, co-founder and CTO, SiriusXT. (Credit: Vincent Hoban, University College Dublin)

DECEMBER - PROFESSIONAL 100 ISSUE - 2023 • HPN | HOSPITALPROFESSIONALNEWS.IE

99 disease, with the ultimate aim of informing novel drug discoveries,” said Professor Jeremy Simpson, Dean of Science and Principal, UCD College of Science.

He added, “The SXT-100 will now complement other cell imaging resources at the UCD Conway Institute and across the UCD College of Science and it will help UCD-based scientists to progress their research as well as to strengthen collaboration with their peers and industry partners, nationally and internationally.”

“We are really excited to be the world’s first imaging laboratory to have a SXT-100,” said Dr Dimitri Scholz, Director of Biological Imaging, UCD Conway Institute.

He added, “This will enable researchers in academia and industry to close the resolution gap between light and electron microscopy as well as to run multiple correlative microscopy projects using combinations of light, soft X-ray and electron microscopy.’’

SiriusXT, an award-winning company headquartered in Dublin, was co-founded by Tony McEnroe, Dr Fergal O’Reilly, Dr Kenneth Fahy and Dr Paul Sheridan, as a UCD spin-out company.

RCSI AND IRISH BLOOD TRANSFUSION SERVICE PARTNERSHIP TO BOOST BLOOD PRODUCTS FOR PATIENTS Researchers from RCSI University of Medicine and Health Sciences and the Irish Blood Transfusion Service (IBTS) are joining forces in a new partnership to make blood products for transfusions more available and more useful for patients.

One of the big issues that Ireland and countries around the world face in providing safe and effective blood products for patients, is that the supply always needs to meet the demand, according to Dr Allison Waters, Research and Development Lead Facilitator at IBTS. “One of the ways we can address this is to make sure the blood products produced following donation are stored under conditions that maintain their quality, safely for longer, as this means more blood products will be available when needed,” says Dr Waters. “In particular we are focusing on developing innovative storage methods to extend the shelf life of donated platelets so they are available for when our patients need them.”

CRIMSON will also investigate the role that blood type plays in how platelets work, particularly in patients who are actively bleeding.

“We will explore how blood group affects the function of platelets and other factors involved in blood clotting,” explains Consultant Haematologist Professor James O’Donnell, Director of the Irish Centre for Vascular Biology and Professor of Vascular Biology at RCSI School of Pharmacy and Biomolecular Sciences. “This will allow us to understand how blood products of different blood types could be used optimally for

patients who are bleeding and who need help to stop that bleeding.”

The CRIMSON initiative is led by Principal Investigators Professor James O’Donnell and Dr Ingmar Schoen at RCSI School of Pharmacy and Biomolecular Sciences and Dr Allison Waters, and Professor Tor Hervig at IBTS. CRIMSON will bring experts together to share knowledge for the benefit of the blood supply in Ireland and beyond, according to Professor Fergal O’Brien, RCSI Deputy Vice Chancellor for Research and Innovation.

“CRIMSON will contribute to the improvement of blood products and transfusion services in Ireland and worldwide, for the benefit of patients. This new research partnership will facilitate the sharing of knowledge and training between clinical and scientific experts at RCSI and the Irish Blood Transfusion Service,” says Professor O’Brien. “ To mark the formation of the new research partnership, haematologist and RCSI

CRIMSON Co-Principal Investigator Professor James O'Donnell delivered an IBTS ‘Leading Lights’ lecture on the topic 'ABO blood group - biology and clinical significance'.

SITAGLIPTIN / METFORMIN CLONMEL Clonmel Healthcare is delighted to announce the launch of Sitagliptin / Metformin Clonmel 50/850mg and 50/1000mg film-coated tablets.

Sitagliptin / Metformin Clonmel in indicated for adult patients with type 2 diabetes mellitus.

Full prescribing information is available on request or alternatively please go to www.clonmel-health. ie. Medicinal product subject to medical prescription.

Please contact Clonmel Healthcare on 01-6204000 if you require any additional information.

PA 126/327/1-2. PA Holder: Clonmel Healthcare Ltd., Clonmel, Co. Tipperary. Date prepared: October 2023. 2023/ADV/ SIT/197H.

Professor Tor Hervig, IBTS; Dr Ingmar Schoen, RCSI; Dr Allison Waters, IBTS; and Professor James O’Donnell, RCSI at the launch of CRIMSON

CRIMSON - the Centre for Research Into Major Haemorrhage and Transfusion - is the first joint research initiative between Ireland’s national blood establishment, the IBTS, and the Irish Centre for Vascular Biology, which is based at RCSI’s School of Pharmacy and Biomolecular Sciences.

Through a series of projects, the new partnership will help to address the ever-growing challenge of meeting the demand for blood products, and in particular platelets, small components of blood that play a vital role in the body’s healing and immune responses. Platelets are present in donated blood and can also be isolated and given to patients separately.

CRIMSON will research ways to optimise shelf-life for donated platelets and ways to derive more benefit for patients from platelet transfusions.

HOSPITALPROFESSIONALNEWS.IE | HPN • DECEMBER - PROFESSIONAL 100 ISSUE - 2023

THE FASTEST GROWING ORAL REGIMEN FOR PLHIV 1*

Virological suppression is the first step to achieving

For your patients living with HIV, make DOVATO a part of their healthy future.

DOVATO DURABLE AND ROBUST2,3

PART OF HEALTHY LIVING WITH HIV

WITHOUT TDF, TAF AND ABC

DOVATO is indicated for the treatment of HIV-1 in adults and adolescents above 12 years weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

Abridged Prescribing Information Dovato (dolutegravir 50mg/lamivudine 300mg) tablets See Summary of Product Characteristics (SmPC) before prescribing.

Presentation: Film-coated tablet containing dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine debossed with “SV-137” on one face. Indication: HIV-1 in adults & adolescents above 12 years of age weighing >40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. Dosing: One tablet once daily with or without food.

Use an additional 50mg tablet of dolutegravir approximately 12 hours after the dose of Dovato when co-administered with efavirenz, nevirapine, tipranavir/ritonavir, etravirine (without boosted PI), carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John’s Wort or rifampicin.

Elderly: Limited data in 65+ yrs. Renal impairment: Not recommended in patients with creatinine clearance < 30 mL/min. For patients with a sustained creatinine clearance between 30 and 49 mL/min see SmPC section 4.4. Hepatic impairment: Caution in severe hepatic impairment (Child-Pugh grade C). Contraindications: Hypersensitivity to any ingredient. Co-administration with substrates of OCT-2 with narrow therapeutic windows, such as fampridine. Special warnings/precautions: Risk of hypersensitivity reactions. Discontinue dolutegravir and other suspect agents immediately. Risks of osteonecrosis, immune reactivation syndrome. Monitor LFTs in Hepatitis B/C co-infection and ensure effective Hepatitis B therapy. Caution with metformin: monitor renal function and consider metformin dose adjustment. Use with etravirine requires boosted PI or increased dose of dolutegravir. Use with Mg/Al-containing antacids requires dosage separation. Use with calcium, multivitamins or iron also requires dosage separation if not taken at the same time with food. Use with cladribine or emtricitabine not recommended. When possible, avoid chronic co-administration of sorbitol or other osmotic acting alcohols (see SmPC

section 4.5). If unavoidable, consider more frequent viral load monitoring. Fertility, pregnancy and lactation: Human fertility - no data; animal fertility - studies indicate no effects. Women of childbearing potential (WOCBP) should be counselled about the potential risk of neural tube defects including consideration of effective contraceptive measures. If a woman plans pregnancy, the benefits and the risks of continuing treatment should be discussed with the patient. The safety and efficacy of a duel regime has not been studied in pregnancy. If a pregnancy is confirmed in the first trimester while on Dovato, the benefits and risks of continuing Dovato versus switching to another antiretroviral regimen should be discussed with the patient taking the gestational age and the critical time period of neural tube defect development into account (see SmPC section 4.6).

There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues. Do not breast-feed. Side effects: See SmPC for full details. Headache, GI disturbance, insomnia, abnormal dreams, depression, anxiety, dizziness, somnolence, rash, pruritus, alopecia, fatigue, arthralgia, myalgia, hypersensitivity, completed suicide, suicidal ideation or suicide attempt, panic attack, hepatitis, blood dyscrasias, acute hepatic failure, pancreatitis, angioedema, rhabdomyolysis, lactic acidosis, peripheral neuropathy. Elevations of bilirubin, ALT, AST and CPK. Weight increased. MA Nr: EU/1/19/1370/001. MA holder: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands. Legal Category: POM A. Date of preparation of API: September 2022. Code: PI-6305. Further information available from GlaxoSmithKline, 12 Riverwalk, Citywest, Business Campus, Dublin 24. Tel: 01-4955000.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

*From November 2020 through October 2021, over 39 markets and territories with data sources available.

References: 1. Data on file. Regimen market share growth November 2020-October 2021. REF-146400. ViiV Healthcare group of companies. Research Triangle Park, NC. 2. Cahn P, Sierra Madero J, Arribas JR, et al. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral treatment-naïve adults with HIV-1 infection. AIDS. 2022;36(1): 39-48. doi:10.1097/QAD.0000000000003070 3. Osiyemi O, De Wit S, Ajana F, et al. Efficacy and safety of switching to dolutegravir/lamivudine (DTG/3TC) versus continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with HIV-1: results through week 144 from the phase 3, non-inferiority TANGO randomized trial. Clin Infect Dis. 2022;ciac036 and suppl 1-18. doi:10.1093/cid/ciac036

DOVATO is owned by or licensed to the ViiV Healthcare group of companies. ©2023 ViiV Healthcare group of companies or its licensor.

Date of preparation: February 2023

PM-IE-DLL-ADVT-230001