Irish Pharmacist March 2025 by GreenX Publishing

THE WRONG ROAD TO RECOVERY?

Terry Maguire wonders if we have been taking the wrong approach to ADHD all along

CLINICAL CONTENT

Written by pharmacists, for pharmacists: Diabetes Sports Injuries

Heart Health

EPIC FAIL

A new report examines the 'puzzling' delay in getting pharmacists involved in Covid-19 vaccination

DUAL ACTION PAIN RELIEF

Generic Product Launch

Pomalidomide Teva

hard capsules pomalidomide

Visit Patientsafetyhub.ie and register today.

The Patient Safety Hub is an online platform for medicines that require pregnancy prevention programmes.

Indications

Pomalidomide Teva 1 mg, 2 mg, 3 mg and 4 mg hard capsules

High Tech

Prescription Only Medicine

Pomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

Pomalidomide Teva in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Pomalidomide Teva Abbreviated Prescribing Information

Presentation: Each hard capsule contains 1mg, 2mg, 3mg and 4mg pomalidomide respectively. Indications: In combination with bortezomib and dexamethasone, Pomalidomide Teva is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Also, in combination with dexamethasone, is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. Dosage and administration: For oral use. Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma. Dosing is continued or modified based upon clinical and laboratory findings. Adults: Please see SmPC for recommended dosing scheme for pomalidomide in combination with bortezomib and dexamethasone, as well as dose modification instructions for pomalidomide, bortezomib and dexamethasone. Pomalidomide in combination with bortezomib and dexamethasone: Recommended starting dose of 4mg once daily (Day 1 to 14) of repeated 21-day cycles. Pomalidomide in combination with dexamethasone: Recommended starting dose of pomalidomide is 4mg once daily (Days 1 to 21 of each 28-day cycle). Children: Not recommended for use in patients aged 0-17 years. Elderly: No dose adjustment required. Renal impairment: No dose adjustment of pomalidomide is required for patients with renal impairment. On haemodialysis days, patients should take their pomalidomide dose following haemodialysis. Hepatic impairment: Patients with serum total bilirubin > 1.5 x ULN (upper limit of normal range) were excluded from clinical studies. Hepatic impairment has a modest effect on the pharmacokinetics of pomalidomide. No adjustment of the starting dose of pomalidomide is required for patients with hepatic impairment as defined by the Child-Pugh criteria. However, patients with hepatic impairment should be carefully monitored for adverse reactions and dose reduction or interruption of pomalidomide should be used as needed. Contraindications: Pregnancy; Patients of childbearing potential, unless all the conditions of the pregnancy prevention programme are met; Male patients unable to follow or comply with the required contraceptive measures; Hypersensitivity to the active substance or to any of the excipients. Precautions and warnings: Pomalidomide must not be taken during pregnancy, since a teratogenic effect is expected. Please consult SmPC for criteria for patients of non-childbearing potential and counselling for patients of child-bearing potential and respective male partners). Patients of childbearing potential must use at least one effective method of contraception for at least 4 weeks before therapy, during therapy, and until at least 4 weeks after pomalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis. If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated. According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25mIU/mL must be performed for patients of childbearing potential. This requirement includes patients of childbearing potential who practice absolute and continuous abstinence. A medically supervised pregnancy test should be performed prior to starting treatment, when pomalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks. The test should ensure the patient is not pregnant when she starts treatment with pomalidomide. A medically supervised pregnancy test should be repeated at least every 4 weeks, including at least 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation. These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber. Patients should not donate blood, semen or sperm during treatment (including during dose interruptions) and for at least 7 days following discontinuation of pomalidomide. Healthcare professionals and caregivers should wear disposable gloves when handling the blister or capsule. Individuals who are pregnant or suspect they may be pregnant should not handle the blister or capsule.

Teva Pharmaceuticals Ireland, Digital Office Centre Swords, Suite 101 - 103, Balheary Demesne, Balheary Road, Swords, Co Dublin, K67E5AO, Ireland.

Freephone: 1800 - 201 700 | Email: info@teva.ie Prescription Only Medicine.

Neutropenia was the most frequently reported Grade 3 or 4 haematological adverse reaction in patients with relapsed/refractory multiple myeloma, followed by anaemia and thrombocytopenia. Patients should be monitored for haematological adverse reactions, especially neutropenia. Patients should be advised to report febrile episodes promptly. Complete blood counts should be monitored at baseline, weekly for the first 8 weeks and monthly thereafter. Patients may require use of blood product support and /or growth factors. Patients receiving pomalidomide either in combination with bortezomib and dexamethasone or in combination with dexamethasone have developed venous thromboembolic events (predominantly deep vein thrombosis and pulmonary embolism) and arterial thrombotic events (myocardial infarction and cerebrovascular accident). Patients with known risk factors for thromboembolism – including prior thrombosis – should be closely monitored. Action should be taken to try to minimise all modifiable risk factors. Cases of hypothyroidism have been reported. Optimal control of co-morbid conditions influencing thyroid function is recommended before start of treatment. Baseline and ongoing monitoring of thyroid function is recommended. Cardiac events, including congestive cardiac failure, pulmonary oedema and atrial fibrillation, have been reported, mainly in patients with pre-existing cardiac disease or cardiac risk factors. Patients at greatest risk of tumour lysis syndrome are those with high tumour burden prior to treatment. Second primary malignancies, such as non-melanoma skin cancer, have been reported in patients receiving pomalidomide. Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies and institute treatment as indicated. Pomalidomide must be discontinued for exfoliative or bullous rash, or if Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspected, and should not be resumed following discontinuation for these reactions. Dizziness and confusional state have been reported with pomalidomide. Patients must avoid situations where dizziness or confusion may be a problem and not to take other medicinal products that may cause dizziness or confusion without first seeking medical advice. Interstitial lung disease and related events, including cases of pneumonitis, have been observed with pomalidomide. Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude ILD. Pomalidomide should be interrupted pending investigation of these symptoms and if ILD is confirmed, appropriate treatment should be initiated. There have been cases of hepatitis that resulted in discontinuation of pomalidomide. Regular monitoring of liver function is recommended for the first 6 months of treatment with pomalidomide and as clinically indicated thereafter. Reactivation of hepatitis B has been reported rarely in patients receiving pomalidomide in combination with dexamethasone who have previously been infected with the hepatitis B virus. Some of these cases have progressed to acute hepatic failure, resulting in discontinuation of pomalidomide. Hepatitis B virus status should be established before initiating treatment with pomalidomide. Cases of progressive multifocal leukoencephalopathy, including fatal cases, have been reported with pomalidomide. PML was reported several months to several years after starting the treatment with pomalidomide. If PML is suspected, further dosing must be suspended until PML has been excluded. If PML is confirmed, pomalidomide must be permanently discontinued. Interactions: Pomalidomide is not anticipated to cause clinically relevant pharmacokinetic interactions due to P450 isoenzyme inhibition or induction or transporter inhibition when co-administered with substrates of these enzymes or transporters. The potential for such interactions, including the potential impact of pomalidomide on the pharmacokinetics of combined oral contraceptives, has not been evaluated clinically. Pomalidomide is partly metabolised by CYP1A2 and CYP3A4/5. It is also a substrate for P-glycoprotein. Coadministration of pomalidomide with the strong CYP3A4/5 and P-gp inhibitor ketoconazole, or the strong CYP3A4/5 inducer carbamazepine, had no clinically relevant effect on exposure to pomalidomide. Co-administration of the strong CYP1A2 inhibitor fluvoxamine with pomalidomide in the presence of ketoconazole, increased mean exposure to pomalidomide.

Co-administration of multiple doses of up to 4mg pomalidomide with 20mg to 40mg dexamethasone (a weak to moderate inducer of several CYP enzymes including CYP3A) to patients with multiple myeloma had no effect on the pharmacokinetics of pomalidomide compared with pomalidomide administered alone. Pregnancy and lactation: Patients of childbearing potential should use effective method of contraception. If pregnancy occurs in a patient treated with pomalidomide, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice. If pregnancy occurs in a partner of a male patient taking pomalidomide, it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice. Pomalidomide is present in human semen. As a precaution, all male patients taking pomalidomide should use condoms throughout treatment duration, during dose interruption and for 7 days after cessation of treatment if their partner is pregnant or of childbearing potential and has no contraception. A teratogenic effect of pomalidomide in humans is expected. Pomalidomide is contraindicated during pregnancy and in patients of childbearing potential, except when all the conditions for pregnancy prevention have been met. It is unknown whether pomalidomide is excreted in human milk. Because of the potential for adverse reactions in breastfed infants from pomalidomide, a decision must be made whether to discontinue breast-feeding or to discontinue the medicinal product, taking into account the benefit of breast-feeding for the child and the benefit of the therapy for the patient. Effects on ability to drive and use machines: Pomalidomide has minor or moderate influence on the ability to drive and use machines. Fatigue, depressed level of consciousness, confusion, and dizziness have been reported with the use of pomalidomide. If affected, patients should be instructed not to drive cars, use machines or perform hazardous tasks while being treated with pomalidomide. Adverse reactions: Pneumonia, bronchitis, upper respiratory tract infection (including viral), sepsis, septic shock, neutropenic sepsis, C. difficile colitis, bronchiolitis, urinary tract infection, herpes zoster, hepatitis B reactivation, basal cell carcinoma, squamous cell carcinoma of the skin, neutropenia, thrombocytopenia, leucopenia, febrile neutropenia, pancytopenia, angioedema, anaphylactic reaction, solid organ transplant rejection, hypothyroidism, hypokalaemia, tumour lysis syndrome, syncope, depressed level of consciousness, intracranial haemorrhage, cerebrovascular accident, cataract, atrial fibrillation, cardiac failure, myocardial infarction, deep vein thrombosis, gastrointestinal haemorrhage, hyperbilirubinaemia, hepatitis, DRESS, TEN, SJS, acute kidney injury, renal failure. Very Common: Influenza, anaemia, hyperglycaemia, decreased appetite, insomnia, peripheral sensory neuropathy, dizziness, tremor, dyspnoea, cough, diarrhoea, vomiting, nauseas, constipation, abdominal pain, rash, muscular weakness, back pain, muscle spasms, fatigue, pyrexia, peripheral oedema. Common: Bronchopneumonia, respiratory tract infection, lower respiratory tract infection, lung infection, nasopharyngitis, lymphopenia, urticaria, hypomagnesaemia, hypocalcaemia, hypophosphataemia, hyperkalaemia, hypercalcaemia, hyponatraemia, hyperuricaemia, depression, confusional state, peripheral sensorimotor neuropathy, paraesthesia, dysgeusia, vertigo, hypotension, hypertension, pulmonary embolism, epistaxis, interstitial lung disease, upper abdominal pain, stomatitis, dry mouth, abdominal distention, pruritus, bone pain, chronic kidney injury, urinary retention, non-cardiac chest pain, oedema, fall, alanine aminotransferase increased, weight decreased, neutrophil count decreased, white blood cell count decreased, platelet count decreased, blood uric acid increased. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: Pomalidomide doses as high as 50mg as a single dose in healthy volunteers have been studied without reporting serious adverse reactions related to overdose. Doses as high as 10mg once-daily multiple doses in multiple myeloma patients have been studied without reported serious adverse reactions related to overdose. The dose-limiting toxicity was myelosuppression. In studies, pomalidomide was found to be removed by haemodialysis. In the event of overdose, supportive care is advised. Legal category: POM. Marketing Authorisation Number: EU/1/24/1868/001-048. Marketing Authorisation Holder: TEVA GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany. Job Code: MED-IE-00090. Date of Preparation: January 2025.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com

A sign of madness in Government

The quote is often attributed to Roy Keane: "I nsanity is doing the same thing over and over again and expecting different results." It was in fact Einstein who was originally credited with this quote, but the principle is still sound, whether it be applied to the laboratory or the Irish football team's preparations. Or pharmacy policies.

In this issue, we report on a recent study that looked at the seemingly inexplicable delay in getting pharmacists involved in the Covid-19 vaccination plans. Titled 'What Obstructs Health Policy Implementation? A Multi-Method Qualitative Case Study of the Delayed Deployment of Community

Covid-19 Vaccination Programme', the research is eye-opening. The researchers set out to assess what may have accounted for the delay between 15 December 2020 (publication of policies) and 14 June 2021 (commencement of community pharmacy–based vaccination).

It is the first health policy analysis exploring the delayed implementation of community pharmacy-based Covid-19 vaccination in Ireland, and is well worth a read. The authors cite regulatory frameworks, political considerations, and medical sector dominance as stumbling blocks to pharmacy participation, but stress that these still should not have resulted in the "puzzling" delay in getting pharmacies involved. They

framework governing pharmacy vaccination; integration of IT systems between pharmacies and the broader health system; and a cohesive leadership between the pharmacy bodies, including Chief Pharmacy Officers in the HSE and DoH.

Policy-makers love an evidence base, and this report can surely be considered as such. It's a question of 'when', not 'if', the next pandemic will manifest. Before everyone again goes insane in their quest for toilet roll, policy-makers should have pharmacists near the top of their 'to do' list when it comes to preparation. Anything less would be an insult to the profession and the public it serves.

Pat Kelly

Breaking news Earn CPD points by completing our modules on www.medilearning.ie

Sharpen your knowledge with our clinical content Enjoy archives of your favourite columnists

News

04: News

National and international news in pharmacy

18: Epic fail

A study highlights the 'puzzling' delay in getting pharmacists involved in Covid-19 vaccination

19: Hi gh Society

The nomination process is now open for appointments to the PSI Council

20: Parallel lines

The IIOP recently hosted a parallel session as part of the RCSI Charter Week Meeting

Comment

24: Fintan Moore

Even Einstein would struggle with the confounding variables in the dispensary

26: Dr Des Corrigan

There's a lot we can learn from the self-care habits of animals

29: Áine Mac Grory

There's more to pharmacist involvement in the free NRT scheme than meets the eye

32: Terry Maguire

A fresh look at the surge in ADHD diagnoses

34: Ultan Molloy

We need to let go of troublesome customers for our own sakes

36: Niamh Cahill

The role of the pharmacist as a healer

In Focus

38: Diabetes

Treatment considerations in the different types of diabetes and the role of the pharmacist

43 : Sports injuries

With all the health benefits associated with sport, chronic or acute injuries can be a major downside

48 : Foot care

The pharmacy has become the first line in the treatment of most common foot problems

Editor

Pat Kelly, pat@greenx.ie

Subeditor

Elaine Walsh

elaine@greenx.ie

Creative Director

Laura Kenny

laura@greenx.ie

Administration Manager

Daiva Maciunaite, daiva@greenx.ie

Managing Director

Graham Cooke, graham@greenx.ie

GreenCross Publishing was established in 2007. Publisher and Managing Director: Graham Cooke, graham@greenx.ie

Cover design: Laura Kenny. Imagery used: iStock.com

The contents of Irish Pharmacist are protected by copyright. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means – electronic, mechanical or photocopy recording or otherwise –whole or in part, in any form whatsoever for advertising or promotional purposes without the prior written permission of the editor or publishers.

50 : Heart Health

Cardiovascular disease is the second-leading cause of death in Ireland, but prevention and early intervention can save many people's lives

Life

53: Gallery

The Vanquished Writing History exhibition highlights those on the margins of society

54: Covering new ground

Shane O'Donoghue test-drives the new Cupra Terramar, a new SUV that brings the brand into the mainstream

56: Book review

Prof Brendan Kelly reviews a new book that sheds light on neglected aspects of the Grangegorman story

Products

57: Product News

A round-up of product and industry news

Disclaimer

The views expressed in Irish Pharmacist are not necessarily those of the publishers, editor or editorial advisory board. While the publishers, editor and editorial advisory board have taken every care with regard to accuracy of editorial and advertisement contributions, they cannot be held responsible for any errors or omissions contained.

Adex Gel has been shown to improve atopic eczema from moderate to mild

in 2 weeks without corticosteroids1

Summary of trial results

In a recent trial of children with moderate atopic eczema, conducted in NHS GP practices (to reflect real-life settings), the mean disease severity score (SCORAD) improved significantly:

• from 37.14 (moderate atopic eczema) at baseline

• to 22.56 (mild atopic eczema) after 2 weeks

• and to 18.48 (mild atopic eczema) after 4 weeks, per protocol analysis of 41 children.

Adex Gel

Bridges the gap between plain emollients and topical corticosteroids.

Adex Gel is an emollient with an ancillary anti-inflammatory, nicotinamide 4%, to help reduce inflammation.

Adex Gel can be used continuously, for as long as necessary, all over the body including on the face, hands and flexures. Available on NHS prescription and suitable for patients aged 1 year+.

In addition, the mean children’s dermatology life quality index score (CDLQI) improved significantly from 9.3 (moderate effect on child) at baseline, to 3.7 (small effect on child) after 4 weeks.

Application of Adex Gel in the trial

Three times daily, for 4 weeks, instead of usual emollient or as the first-line treatment for moderate atopic eczema, in both scenarios, without supplementary use of any oral or topical steroids or immunomodulators.

Adex Gel has been shown to be an effective treatment for moderate atopic eczema in children in a real-world setting.

SCORAD is a tool used in clinical trials to assess atopic dermatitis severity based on disease area, intensity and subjective symptoms (itch and sleeplessness). The CDLQI is designed to measure the impact of any skin disease on the lives of children.

Product name: Adex™ Gel. Key ingredients: Isopropyl myristate 15%, liquid paraffin 15%, nicotinamide 4%. Uses: Highly moisturising and protective emollient with an ancillary anti-inflammatory medicinal substance for the treatment and routine management of dry and inflamed skin conditions such as mild to moderate atopic dermatitis, various forms of eczema, contact dermatitis and psoriasis. Package sizes: 100g tube and 500g pump pack. Further information is available from: Dermal Laboratories Ltd, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK. ‘Adex’ is a trademark.

Adverse Events/Incidents should be reported. Reporting forms and information for the UK can be found at yellowcard.mhra.gov.uk, and for the Republic of Ireland at www.hpra.ie. Adverse Events/Incidents should also be reported to Dermal.

SCORAD, SCORing Atopic Dermatitis. CDLQI, Children’s Dermatology Life Quality Index.

Reference: 1. Gallagher J. et al. Evaluation of a nicotinamidecontaining emollient for moderate atopic eczema in paediatric patients:

A prospective, multi-centre GP study reﬂecting real-life settings. Data presented at the Annual Meeting of the Austrian Society of Dermatology and Venereology (ÖGDV), November 2024, Graz, Austria.

New blood test could end need for lumbar puncture in Alzheimer’s diagnosis

Researchers at Trinity College Dublin, the Tallaght Institute of Memory and Cognition and St James’s Hospital, Dublin, are exploring the ability of a new blood test, plasma p-tau217, to detect Alzheimer’s disease (AD). This test could potentially replace the current diagnostic method, a lumbar puncture/spinal tap (which is invasive and poses risks and challenges) in over half of patients with early symptoms, thus allowing more patients to be diagnosed more accurately and with greater efficiency.

The study was recently published in the journal Alzheimer’s & Dementia: Diagnosis, Assessment and Disease Monitoring In Ireland, over 60,000 people live with dementia, with Alzheimer’s disease accounting for about 70 per cent of cases. In order to enable accurate diagnosis, biomarkers are currently measured in cerebrospinal fluid (CSF) obtained using a diagnostic lumbar puncture (LP) procedure. Of those in Ireland currently living with Alzheimer’s disease, up to half do not have a formal diagnosis, highlighting the need for improved diagnostic methods which are accurate and can be used at scale.

The study is one of the first in Europe to examine the ‘real-world’ performance of one of the leading automated blood tests for Alzheimer’s disease, plasma p-tau217, in patients with mild symptoms undergoing assessment in a specialist memory service. One hundred and fortyeight patients attending Tallaght University Hospital (TUH) generously donated blood and cerebrospinal fluid (CSF) samples at the time of their LP, enabling researchers to directly compare new blood tests to established CSF biomarkers.

Crucially, this was performed using fully-automated technology (Lumipulse), which already exists in clinical diagnostic laboratories. The use of a fully-automated system increases reliability over time in the laboratory, as well as reliability between different laboratories.

The study found that measuring plasma p-tau217 using a fully-automated system was >90% as accurate as results obtained from LP. Integrating the blood test into clinical pathways could potentially avoid the need for over half of diagnostic LPs. This has clear implications for the diagnosis and management of early Alzheimer disease, said the authors.

Ireland has second-highest rate of new cancer diagnoses in Europe

Following a mixed ‘report card’ for Ireland from the European Commission Country Cancer profiles, the Irish Cancer Society is calling on the new Minister for Health to prioritise improvements in cancer care. In particular, it is calling for expanded screening services, shorter waiting times for cancer tests and treatment, and faster access to new medicines.

Every two years, the European Cancer Inequalities Registry publishes data on cancer prevention and care to highlight

the strengths, challenges and specific areas of action for each of the 27 EU Member States, Iceland and Norway.

This year’s report card for Ireland shows some positives:

 Ireland outperforms most EU countries in managing key risk factors for cancer, such as tobacco use.

 Alcohol consumption in Ireland has decreased and is slightly under the EU average.

 Consumption of fruit and vegetables is

From their results, the research team believe that this new blood test could replace over half of the 150-200 diagnostic LP procedures that they currently carry out in the Tallaght Institute of Memory and Cognition every year.

Dr Jean Dunne, Chief Medical Scientist, Department of Immunology, St James’s Hospital and Trinity Translational Medicine Institute (TTMI), said: “This blood test is not available currently in Ireland and the findings from this research will lend support to making it available in the future. This ‘translation’ from a research to a diagnostic test is dependent on the scientists, the clinical teams and the support from hospital management.

“Using this automated analyser, the scientists at St James’s will be able to deliver a reliable and reproducible diagnostic test result. The quality assurance carried out in the diagnostic laboratory includes comparison of results achieved to those reported internationally. All of this research will benefit the patient and the clinical teams and combines the research and diagnostic expertise to deliver a worldclass, patient-centered service.”

higher here than the EU average.

 The percentage of Irish adults engaging in insufficient physical activity, at 51 per cent in 2022, was significantly lower than the EU average of 70 per cent.

 Of those eligible for breast and cervical cancer screening, participation is higher in Ireland than the EU average.

However, there are many areas of concern:

 Ireland had the second-highest rate of new cancer diagnoses among EU countries in 2022.

 While Ireland’s cancer mortality rate declined significantly between 2011 and 2021, it was still higher than the EU average and the third-highest in Western Europe.

 While Ireland has a higher ratio of physicians and nurses per 1,000 new cancer cases than the EU average, it has a shortage of GPs, radiologists, radiation therapists and other key medical personnel.

 The supply of diagnostic equipment, such as MRI and CTI scanners, is significantly lower here than the EU average.

 Vaping rates among Irish 15-to-24 yearolds have increased dramatically, from 1 per cent in 2015, to 10 per cent in 2023.

 Irish patients have access to a narrower range of new oncology medicines than the EU average.

The report also warns that the cost of cancer care in Ireland is set to rise. Per capita health expenditure on cancer care is expected to grow by 80 per cent in Ireland between 2023 and 2050, compared to 59 per cent in the EU27.

Averil Power, CEO of the Irish Cancer Society, said: “This comparative data highlights the sad fact that you are more likely to get and die from cancer in Ireland than in many other European countries. It must serve as a wake-up call to Government.

“Without urgent action, both individuals and the State face an

National Tongue Tie Centre launches courses for healthcare professionals

The National Tongue Tie Centre, a leading provider of medical and therapeutic services for oral restrictions, has launched its educational platform, The Tongue Tie Toolbox. The toolbox is a comprehensive collection of courses to help educate healthcare professionals in identifying and addressing the needs of patients with oral dysfunctions.

The tongue is involved in how we breathe, sleep, chew, swallow, and talk. If dysfunctional, it can have knock-on effects throughout the body, including on posture and development. Tongue tie creates tongue dysfunction and affects approximately 5-to-10 per cent of the population. It occurs when the tissue that attaches the tongue to the floor of the mouth (the frenulum) is short, thick, or inelastic, restricting the tongue's range of movement.

Co-directors of the National Tongue Tie Centre and Creators of the Tongue Tie Toolbox, Dr Justin and Kate Roche, have the benefit of over two decades

of work with tongue ties and are at the forefront of treatment for this condition.

Kate Roche said: “Tongue tie is a condition that is poorly understood and underestimated, both in its implications for infants and for an individual’s long-term health. As awareness of tongue tie grows, professionals are being asked to advise their patients without adequate training in this subject. The training that we are offering will help professionals better understand the condition and improve patient outcomes in the long run.”

The Tongue Tie Toolbox offers a comprehensive array of learning opportunities. Healthcare professionals can choose to dip in as they like and build the ‘toolkit’ they need, depending on their patients' needs and their own scope of practice.

The first course will focus on equipping lactation consultants and therapists who work with infants with an understanding of when to suspect a tongue tie and a comprehensive set of

enormous cancer burden in the coming years. Much of this could be avoided by tackling the delays in diagnosis and treatment that are Ireland’s biggest obstacle to improved cancer outcomes. When cancer is picked up early, it is far easier and cheaper to treat. Investing now in expanded screening services and reduced waiting times for cancer tests and treatment would lead to significant savings for the State in the long-term. It would also save lives.

“We must also redouble our efforts to stop people getting cancer in the first place. Four out of 10 cancers are preventable through lifestyle changes, like not smoking, reducing alcohol intake, and maintaining a healthy weight.”

treatment techniques when tongue tie has been diagnosed.

This initiative underscores the National Tongue Tie Centre’s mission to set new standards in tongue tie management and support better outcomes for patients of all ages. Throughout the year, more courses will be introduced, including modules tailored to provide surgical insights and further therapy, as well as dedicated sessions for infants, children, and adults. In addition to the formal courses, the Centre will foster an ongoing community through its monthly online live discussions, ‘Tie Talk: Comprehensive Care Conversations’. These sessions will feature expert-led discussions on case studies with founders Justin and Kate Roche. They will provide opportunities for healthcare professionals to share insights and experiences and build a platform for advancing collaborative care.

Find more details at https://www. tonguetietoolbox.com/.

UG researchers create world’s largest digital microbe collection to transform health research

Researchers at University of Galway (UG) have created the world’s largest collection of digital microbes — nearly a quarter-million computer models — to help revolutionise our understanding of the human microbiome and its impact on health.

This study focuses on the bacterial microbiome, the communities of bacteria living in and on our bodies.

The team created APOLLO, a collection of 247,092 advanced computer models, each representing the unique metabolic processes of a distinct microbe found within these communities.

The unprecedented database will allow scientists to use software to study how microbes function within the human body and interact with health and disease to accelerate new health discoveries, which would otherwise solely rely on cumbersome experiments using living organisms.

Spanning multiple continents, age groups and body sites, APOLLO is the most extensive computational model collection of the human microbiome created to date.

The research project builds upon the team’s decade-long expertise, from earlier AGORA (hundreds of microbes) and AGORA2 (thousands of microbes) generations.

The team also created 14,451 computer simulations of individual microbiome communities, based on real-life samples, to reveal how microbial metabolism varies by body site, age, and health conditions. The APOLLO simulations also predicted key faecal metabolites linked to Crohn’s disease, Parkinson’s disease, and child undernutrition – insights that could help shape future diagnostic and treatment strategies.

The work was conducted by a team of scientists at University of Galway’s Digital Metabolic Twin Centre, led by Prof Ines Thiele, a principal investigator with APC

Microbiome Ireland, Research Ireland centre for the study of microbiological community, hosted by University College Cork.

Prof Thiele’s research team uses computational modelling to advance precision health.

Dr Cyrille Thinnes, project scientist, said: “APOLLO marks a major milestone in personalised microbiome modelling on a global scale. Our microbiome plays crucial roles in digestion, immune function, and overall health. Studying these microbes is essential for understanding how they influence various conditions, from gut health to neurological diseases, and for developing new diagnostic tools, treatments, and personalised healthcare solutions.

“APOLLO captures an unprecedented diversity of microbes across continents, demographics and body sites, filling critical gaps in global health research. It addresses pressing concerns about the impact of Westernised lifestyles, characterised by sedentary habits, processed diets and antibiotic overuse, on microbial diversity

and functions. By including understudied non-Westernised populations and body sites beyond the gut, APOLLO provides a vital resource for advancing microbiome research and its applications.”

Prof Thiele, study lead on the project, added: “Over the past decade, we have gone from a single generic human model, to detailed models that account for sex, physiology, and individual organs. Similarly, we started with models of a few microbes and have now expanded to cover hundreds of thousands. These models can further incorporate information on dietary habits and health conditions, helping to generate testable hypotheses and personalised health recommendations. APOLLO represents a major step in the shift towards digital twin-enabled precision healthcare, moving us closer to tailoring health solutions for individuals worldwide.”

The research was published in Cell Systems and is available at https://www.cell.com/cell-systems/ fulltext/S2405-4712(25)00029-8.

Indicated for Plaque Psoriasis, Paediatric Plaque Psoriasis, Psoriatic Arthritis, Crohn’s Disease1

The NEW ustekinumab biosimilar from Clonmel Healthcare1 Uzpruvo is the first approved ustekinumab biosimilar in Ireland

Cost-effective option enabling improved access to ustekinumab treatment

Equivalent efficacy, safety and immunogenicity to the reference product*2

Patient-friendy PFS: easy handling, thinner needle† , latex-free††1,3

Uzpruvo® is currently not approved for the ulcerative colitis indication (since the originator still has exclusivity for this indication).

PFS - pre-filled syringe. *Stelara®; †29 vs 27-gauge needle of the reference product, Stelara®1,3; ††Plunger stopper made of bromobutyl rubber. 1. Uzpruvo® SmPC (Feb. 2024); 2. Feldman SR et al. Expert Opin Biol Ther. 2023;23(3):253-60. DOI: 10.1080/14712598.2023.2235263; 3. Stelara® PI (Aug. 2022).

UZPRUVO 45 & 90 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE This medicinal product is subject to additional monitoring. Uzpruvo 45 mg: Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL. Uzpruvo 90 mg: Each pre-filled syringe contains 90 mg ustekinumab in 1 mL. Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology. Presentation: Pre-filled glass syringe. Indications: Uzpruvo is indicated for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease. Dosage: Uzpruvo is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which Uzpruvo is indicated. Refer to Summary of Product Characteristics. Method of administration: Subcutaneous injection. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important, active infection. Warnings and precautions: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and Uzpruvo should not be administered until the infection resolves. Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. Serious hypersensitivity reactions have been reported in the postmarketing setting, in some cases several days after treatment. Cases of allergic alveolitis, eosinophilic pneumonia, and noninfectious organising pneumonia have been reported during post-approval use of ustekinumab. Risk factors for cardiovascular disease should be regularly assessed during treatment with ustekinumab. It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with Uzpruvo. Caution should be exercised when considering concomitant use of other immunosuppressants and Uzpruvo or when transitioning from other immunosuppressive biologics. It is not known whether ustekinumab may affect allergy immunotherapy. In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment. Cases of lupus-related conditions have been reported in patients treated with Ustekinumab. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the

elderly. Interactions: Live vaccines should not be given concurrently with Uzpruvo. In psoriasis studies, the safety and efficacy of ustekinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn’s disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of Ustekinumab. Fertility, pregnancy and lactation: Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment. There are no adequate data from the use of ustekinumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Uzpruvo in pregnancy. Limited data from published literature suggests that ustekinumab is excreted in human breast milk in very small amounts. Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with Uzpruvo must be made taking into account the benefit of breast-feeding to the child and the benefit of Uzpruvo therapy to the woman. The effect of ustekinumab on human fertility has not been evaluated. Driving and operation of machinery: Uzpruvo has no or negligible influence on the ability to drive and use machines. Undesirable effects: 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. Refer to Summary of Product Characteristics for other adverse effects. Adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Pack size: 1 pre-filled syringe. A copy of the Summary of Product Characteristics is available upon request or go to www.clonmelhealthcare. ie. Marketing authorisation holder: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany. Marketing authorisation number: EU/1/23/1784/001,004. Medicinal product subject to restricted medical prescription. Date last revised: February 2024.

Date prepared: July 2024. 2024/ADV/UZP/131H

EB medical alert cards to help patients and healthcare staff

A Galway man battling epidermolysis bullosa (EB) has told how Medical Alert Cards will help healthcare professionals learn more about the painful skin condition.

EB charity Debra developed the new information cards to further protect the 300 people living in Ireland with the rare disorder.

The aim is to encourage staff in doctors’ surgeries, hospitals and other healthcare settings to be extremely careful with the skin of patients, which is ultra-fragile and can blister at the mildest touch. In extreme cases, the blisters require daily bandaging, which causes additional pain and distress.

Seamus Graham, from Knocknacarra in Galway, but originally from Killeevan in Monaghan, said explaining his EB to

healthcare professionals is often an “exhausting process”.

“I have cardiomyopathy related to EB, and when I’ve had ECG tests before, I’ve had to ask people not to use ECG stickers on my skin or at least to let me take them off myself, but it has not happened,” he said.

“I hope with the card, whoever admits me to hospital can say to everyone involved in my care that I have EB and what that means. I also feel that in the next 10 years or so, we will reach the point where more people know what EB involves. But until then, I’m very happy to have this card in my wallet.”

The idea for the licence-style

New study reveals how lifelong exercise could protect against dementia

New research funded by Alzheimer’s Research UK and the Medical Research Council sheds light on how staying active throughout your life is linked to changes to the brain, which may make you more ‘cognitively resilient’ and less likely to get dementia.

Led by Dr Sarah-Naomi James, scientists at University College London found that people who engaged in leisure activities involving exercise, especially before the age of 50, had changes in their brain, including a larger hippocampus, the area mainly responsible for memory. People who exercised throughout life were also less likely to experience cognitive decline, even if they had key markers of Alzheimer’s, such as amyloid build-up and brain shrinkage. This was especially true for women. Understanding more about how exercise physically changes the brain and potentially protects people from dementia could lead to new interventions in the future that can stop the condition from happening in the first place.

The findings were published recently in Brain Communications

Dr team previously showed that leading an active life, particularly before age 50, was linked to better memory and thinking abilities at age 70. But until now, it was not clear how regular exercise helps to keep the brain healthy.

As part of the Insight46 study, the team collected information on how frequently a person self-reported taking part in physical activity for leisure across 30 years, before and after they turned 50. The team then analysed brain scans taken when the participants were 70 years old, to see if physical changes in the brain were linked to lifelong exercise.

The team found that people who said they exercised once or more a month from before they were 50 years old tended to have less shrinking in the brain’s memory centre, the hippocampus. This area is often the first brain region affected in Alzheimer’s disease.

Being physically active wasn’t directly

information card came from Debra’s EB Expert Panel, which raised concerns about how frustrating communicating EB to others can be for those living with it.

“Each card contains information to help medical staff who may have limited knowledge of EB, along with contact details for EB services,” said Deirdre Callis, Head of Family Support at Debra.

“The cards, which are free, are designed to help medical professionals to take the right action during emergencies to help people living with EB to explain their condition more easily.”

For more information or to order a card, visit www.debra.ie.

related with other Alzheimer’s disease markers in the brain, like amyloid plaques or overall brain shrinkage. However, being active throughout life helped those with early Alzheimer’s disease markers to maintain and buffer their cognitive function, and this was particularly the case for women.

Evidence suggests that keeping our brains healthy can help build ‘cognitive reserve and resilience’, helping to help maintain memory and thinking in older age for longer. This is despite the brain ageing and having signs of Alzheimer’s disease.

Again, this beneficial effect was even more prominent in women. Those who had signs of Alzheimer’s disease in their brain, but who were active in the past, were more likely to have better cognitive function than those who were always inactive.

Further research will be needed to explore what aspects of leisure time physical activity may be driving this relationship. This could in the future be used as a preventative intervention for Alzheimer’s disease, said the authors.

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New HSE Health App launched

The Health Service Executive (HSE) recently announced the launch of the new Health App. This innovative tool empowers patients by providing easy access to their health information and will become the digital 'front door' for patients in the coming months and years to navigate and access the health service, said the Executive.

The App is built with the highest standards of security and privacy, said the HSE, ensuring that patients' personal health information is protected, and designed to provide a simple and secure way for patients to some of their personal health information, have control over their health management, access to trusted information sources like HSE Live, and enhanced communication channels.

Anyone aged over 16 can download the app for free from Google Play or the App Store, however first-phase functionality will be most useful for expectant mothers. The first release includes functionality

that allows people to:

 Carry a digital list of self-declared medications and see a list of medicines received through the Drugs Payment Scheme or Medical Card Scheme.

 Store their European Health Insurance Card (EHIC), medical card, Long-term Illness card (LTI), Drugs Payment Scheme card (DPS) and GP Visit card.

 Access flu and Covid-19 vaccination records.

 Easily find information about HSE services, such as Emergency Departments and Injury Units.

 View maternity service appointments (for expectant mothers).

Further planned releases over 2025 will allow people to:

 Access public hospital and screening appointments information for public patients.

 Check referrals and waiting times information.

Maynooth University study reveals how poor sleep impacts Parkinson's patients

Researchers at Maynooth University’s Kathleen Lonsdale Institute for Human Health Research and Department of Psychology have recently published a study showing that sleep problems are very common in people with Parkinson’s disease, and such sleep problems are associated with poorer quality of life in patients. Parkinson’s disease is the secondmost common neurodegenerative brain disease after Alzheimer’s, and is estimated to affect 18,000 people in Ireland, and over six million people worldwide.

The MU study, led by PhD candidate Ziba Asadpoordezaki, Research Fellow Dr Beverley Henley, and Prof Andrew Coogan, was published in the Journal of Sleep Research. The research team analysed data from over 38,000 Parkinson’s patients, gathered by the Michael J Fox Foundation. This comprehensive database includes valuable insights into the patients’

experiences with Parkinson’s, as well as details on their mental health, cognition, and sleep patterns. The findings revealed that an overwhelming 84 per cent of patients with Parkinson’s disease report struggling with sleep issues — significantly higher than the general population of the same age group.

The study highlights the direct consequences of these sleep problems: They were found to be strongly linked to increased symptoms of depression, greater difficulty with independent living, and an overall decline in quality of life. Furthermore, sleep disturbances were found to worsen the severity of ‘OFF periods,’ the times when the effects of Parkinson’s medication diminish, leaving patients vulnerable to a return of debilitating symptoms.

Prof Coogan said: “Sleep problems are a significant burden to quality of life in a number of chronic health conditions. Our

 Receive additional self-care information and support services, including smoking cessation and chronic disease management. The app development team has consulted with a number of organisations representing disabled people and worked with a Patient Advisory Group to understand the needs of a wide range of people. This has ensured their needs are heard and they are involved in the design process. The app has also been tested with users who rely on assistive technology, and audited to ensure it reaches HSE and European standards for accessibility. Work is ongoing with users of the app to identify and implement improvements so new features and functionality can be added.

Future app features will be guided by ongoing research and engagement with patients, staff, and the public. For now, the HSE Health App is available in English and Irish, and other languages are being explored for future versions.

For more information see www.hse.ie/ health-app.

study shows how important sleep is to address in Parkinson’s disease, one of the most common and debilitating brain diseases.”

Prof Coogan also noted the key enablers of their research: “The research database from the Michael J Fox Foundation that we drew on in our study is a great example of the wonderful opportunities presented by large international studies for research that will help advance key questions in human health and benefit patients. In order to best take advantage of such opportunities, we also need collaborations between colleagues, such as facilitated in our study by the Kathleen Lonsdale Institute for Human Health Research at MU, which brings together colleagues with different expertise in health-related research.”

The full study can be found at: https:// onlinelibrary.wiley.com/doi/10.1111/ jsr.14453.

Generic Product Launch

Fluticasone Furoate Teva

27.5 micrograms/spray

Nasal Spray, Suspension

fluticasone furoate

Indications

Fluticasone Furoate Teva 27.5 micrograms/spray, Nasal Spray, Suspension

Fluticasone Furoate Teva is indicated in adults, adolescents and children (6 years and over).

Fluticasone Furoate Teva is indicated for the treatment of the symptoms of allergic rhinitis.

Fluticasone Furoate Teva is indicated for the treatment of the symptoms of allergic rhinitis. Fluticasone Furoate Teva Nasal Spray Abbreviated Prescribing Information.

Fluticasone Furoate Teva Nasal Spray Abbreviated Prescribing Information.

Presentation: Each spray actuation delivers 27.5mcg of fluticasone furoate. One actuation delivers 8.25mcg of benzalkonium chloride. Indications: Indicated in adults, adolescents and children (6 years and older) for the treatment of the symptoms of allergic rhinitis. Dosage and administration: Intranasal route only. Adults, Adolescents (12 years and over): The recommended starting dose is two spray actuations (27.5mcg of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 110mcg). Children (6 to 11 years): The recommended starting dose is one spray actuation (27.5mcg of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55mcg). Children (under 6 years of age): Not recommended for use. Elderly: No dose adjustment required. Renal and Hepatic Impairment: No dose adjustment required. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions and warnings: Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed concurrently. If there is any reason to believe that adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to fluticasone furoate. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases

Teva Pharmaceuticals Ireland, Digital Office Centre Swords, Suite 101 - 103, Balheary Demesne, Balheary Road, Swords, Co Dublin, K67E5AO, Ireland.

Freephone: 1800 - 201 700 | Email: info@teva.ie

Prescription Only Medicine.

such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses. A reduction in growth velocity has been observed in children treated with fluticasone furoate 110mcg/day for one year. Therefore, children should be maintained on the lowest possible efficacious dose which delivers adequate symptom control. It is recommended that the growth of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate. Interactions: Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4. Based on data with another glucocorticoid (fluticasone propionate), that is metabolised by CYP3A4, co-administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate. Caution is recommended when co-administering fluticasone furoate with potent CYP3A inhibitors including cobicistatcontaining products as an increase in the risk of systemic side effects is expected. Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects. Pregnancy and lactation: Fluticasone furoate should be used in pregnancy only if the benefits to the mother outweigh the potential risks to the foetus or child. Administration of fluticasone furoate to patients who are breast-feeding should only be considered if the expected benefit to the patient is greater than any possible risk to the child. Effects on ability to drive and use machines: no or negligible influence on the ability to drive and use machines. Adverse reactions: Hypersensitivity reactions including anaphylaxis, angioedema. Very Common: Epistaxis. Common: Headache, nasal ulceration, dyspnoea. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: In a bioavailability study, intranasal doses of up to 2640mcg/day were administered over three days with no adverse systemic reactions observed. Acute overdose is unlikely to require any therapy other than observation. Legal category: POM. Marketing Authorisation Number: PA1986/126/001. Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands. Job Code: MED-IE-00087. Date of Preparation: October 2024.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie.

Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com

Date of Preparation: January 2025 | Job Code: GEN-IE-00109

Further information is available on request or in the SmPC. Product Information also available on the HPRA website.

Teva Pharmaceuticals Ireland, Digital Office Centre Swords, Suite 101 - 103, Balheary Demesne, Balheary Road, Swords, Co Dublin, K67E5AO, Ireland.

Freephone: 1800 - 201 700 | Email: info@teva.ie

Prescription Only Medicine.

Date of Preparation: January 2025 | Job

Further information is available on request or in the SmPC. Product Information also available on the HPRA website.

St John of God Hospital becomes the first Irish hospital to introduce rTMS as a treatment for depression

St John of God Hospital has announced the introduction of Repetitive Transactional Magnetic Stimulation (rTMS) therapy, in an expansion of its treatment options for patients with depression. This non-invasive therapy offers a new option for patients who have not had sufficient success with conventional depression treatments.

St John of God Hospital will be the first hospital to deliver this treatment for depression on a consultant-led basis. rTMS is a modern treatment for depression that prioritises convenience, comfort, and safety while delivering significant benefits for those with treatment-resistant depression. rTMS uses magnetic pulses to stimulate specific brain regions, promoting the brain’s ability to form new connections and regulate mood.

Around 21 million people in Europe, or 4.5 per cent of the population, experience depression, with higher rates in women (8.8 per cent) than men (5.3 per cent). In

Ireland, 12 per cent of young people (15to-24 years) report chronic depression, the highest rate in Europe.

rTMS is a consultant-led service that offers a unique combination of effectiveness, convenience and safety. The treatment is performed on an outpatient basis and requires no anaesthesia, meaning patients can drive, work, and resume daily activities immediately after their sessions. Its noninvasive nature makes it an attractive option for a wider range of individuals.

Consultant Psychiatrist and Head of Neuromodulation Services Dr Simon Mitchell, who is one of the experts leading the roll-out at St John of God Hospital, commented on the announcement, saying: “The introduction of rTMS at St John of God Hospital represents significant advancement in our mental health services. This non-invasive treatment offers new hope to our patients who haven’t found relief through traditional

methods. This expansion of our psychiatric services reflects St John of God Hospital’s ongoing commitment to providing the most advanced, evidence-based treatments to our patients.”

The effectiveness of rTMS treatment for depressive disorders and treatment-resistant depression has been firmly established in recent years. rTMS was approved for depression treatment by the US Food and Drug Administration (FDA) in 2008, and the UK’s National Institute for Health and Care Excellence (NICE) has also appraised the evidence of the treatment. Clinical studies have shown that approximately 50 per cent of patients experience significant symptom relief with rTMS treatment, with about one-third achieving remission from their depression symptoms.

The typical treatment course consists of daily sessions over four-to-six weeks, with each session lasting about 20-to40 minutes.

Health in Ireland Key Trends 2024 published

The Health In Ireland Key Trends 2024 report was published recently by the Department of Health, illustrating the significant improvements in health outcomes in the past decade, and highlighting some of the challenges in access to timely and efficient healthcare.

Highlights from the publication, which covers demographics, population health, hospital and primary care, health sector employment and expenditure, include:

 The number of people in Ireland who reported their health as being good or very good (79.5 per cent) in 2023 was the highest in the EU, well above the EU average of 67.7 per cent. Ireland also had the highest rate of self-perceived good health in 2022.

 Life expectancy in Ireland is fifth-highest in the EU, at 82.6 years.

 The population has grown by 14.8 per

cent since 2015, with the over-65s group increasing by 36.5 per cent between 2015 and 2024.

 The total number of consultant and non-consultant hospital doctors employed in the public health service in Ireland increased to 13,772 (61.3 per cent increase) between 2015 and 2024.

 The number of nurses and midwives increased to almost 48,000 (34.9 per cent increase) between 2015 and 2024.

 Between 2014 and 2023, the mortality rate from cancer fell by 14.7 per cent, the mortality rate from circulatory system diseases fell by 19.5 per cent, the mortality rate for ischaemic heart disease fell by 27.7 per cent and the mortality rate from respiratory system diseases fell by 15.4 per cent.

 The proportion of total health expenditure paid for either out-of-

pocket or through private health insurance has been reducing in recent years; the Government funded 77.4 per cent of total health expenditure in Ireland in 2023.

Minister for Health Jennifer Carroll MacNeill said: “Our population is growing, and we are living longer healthier lives.

With our average life expectancy now at 82.6 years, the fifth highest in the EU, we need to continue to focus on the future demands for health care.

“The Key Trends report shows our health service is one that continues to deliver better results for the people of Ireland, in some cases among the best in Europe.

“… The information contained in Key Trends is very useful in helping us to monitor the impact of our policies which protect and promote the health of the nation, as well as to keep focused on making improvements as we plan for the future.”

New study reveals link between workaholism and organisational harm

The hidden ethical costs of workaholism have been highlighted in a recent study led by Aston University and University of Leipzig scholars.

Workaholism is an inner pressure to work that provides a sense of fulfilment but can lead to physical and psychological problems, relationship issues and burnout, according to the authors.

The study, published in the Journal of Organisational Behaviour, showed that it can interfere with moral self-regulation and subsequent ethical behaviour, particularly in organisations that prioritise bottom-line results and self-interest.

An international team of researchers, led by Prof Roberta Fida (Aston University) and Dr Michael Knoll (University of Leipzig), conducted two surveys to study workplace behaviour. They gathered responses from employees in Italy (505 people) and the UK (1,046 people) over three different points in time. Their findings show that being a workaholic can cause people to become less engaged with their moral values. This makes them less likely to speak up about ethical problems they notice at work and more likely to stay silent, even when they see something wrong.

The research draws on Bandura’s social cognitive theory of morality, which suggests that moral behaviour is regulated by personal standards and social norms. The researchers found that moral disengagement acts as a critical mediator between workaholism and employee silence or moral voice. Workaholism increases tendencies to morally disengage which, in turn, leads to less moral voice and more employee silence.

Another finding surrounded the role of the organisational context. The second study revealed that a perceived climate of self-interest, where employees believe that individual gain is prioritised over other values such as norms or collective welfare, amplifies the negative

effects of workaholism. In these environments, workaholics were even more prone to morally disengage, further diminishing their likelihood of addressing ethical issues.

Prof Fida said: “We often think of workaholism as a personal struggle or even a badge of dedication, but our research shows it has far-reaching consequences. Workaholics, focused intensely on task completion and personal achievement, tend to disengage from their moral standards. This leads them to rationalise silence in the face of unethical practices, which can preserve behaviours and practices that are potentially damaging to organisations and society at large.

“Our findings highlight the critical need for organisations to rethink their workplace cultures, particularly in sectors where bottom-line mentalities dominate. When workaholism and a selfinterested culture converge, the result

isn’t just burnout — it’s a systemic erosion of ethical standards.”

Dr Knoll added: “Workaholics justify withholding their voice by convincing themselves that their silence is harmless or justified as they need to prioritise finishing their tasks.

“But by doing so, they fail to address pressing organisational issues such as safety risks, unethical leadership, or inefficiencies that affect their colleagues and stakeholders. By normalising silence and neglecting ethical concerns, organisations risk perpetuating harm to employees, stakeholders, and society. It’s not just about individual wellbeing — it’s about organisational sustainability.

“Employers need to move beyond seeing long hours and over-dedication as signs of commitment. Instead, they should foster an organisational culture that rewards ethical behaviour, encourages moral voice, and reduces pressures that lead to excessive working.”

“ Cow’s milk allergy is associated with dysbiosis and increased susceptibility for infections, and it has been suggested that it can be managed (in part) by pro-, pre-, and synbiotics ””

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DRACMA: Diagnosis and Rationale for Action against Cow’s Milk Allergy; GOS: Galacto-Oligosaccharides; FOS: Fructo-Oligosaccharides

1. Jensen SA et al. World Allergy Organization Journal. Diagnosis and Rationale for Action against Cow’s Milk Allergy. 2022;15:100668. 2. Burks AW et al. Pediatr Allergy Immunol. 2015;26(4):316–22. 3. Candy DCA et al. Pediatric Res. 2018;83(3):677–86. 4. Fox AT et al. Clin Transl Allergy. 2019;9(1):5. 5. Chatchatee P et al. JACI. 2021;0091-6749(21)01053-8 6. Van der Aa LB et al. Clin Exp Allergy. 2010;(40):795–804. 7. Martin R et al. Benef Microbes. 2010;1(4):367–82. 8 Wopereis H et al. Pediatr Allergy Immunol. 2014;25:428–38. 9. West CE et al. J Allergy Clin Immunol. 135(1):3–13.10Walker WA et al. Pediatr Res. 2015;77(1):220-8. IMPORTANT NOTICE: Breastfeeding is best. Foods for special medical purposes should only be used under medical supervision. May be suitable for use as the sole source of nutrition for infants from different ages, and/or as part of a balanced diet from 6 months onwards. Refer to label for details.

Nutricia Ireland, Deansgrange Business Park, Deansgrange Co. Dublin. Date of publication: April 2024

Pharmacy reforms needed to boost Ireland’s pandemic preparedness

New research highlights ‘puzzling’ delay in getting pharmacists involved in Covid-19 vaccination

Health system reforms to further integrate the community pharmacy sector are required to strengthen Ireland’s pandemic preparedness, according to new research conducted by health policy analysts from Trinity College Dublin.

Legislative changes to expand pharmacists’ roles, particularly during public health emergencies, are among the recommendations outlined in the new research published in the journal Qualitative Health Research . The researchers also called for improved IT integration between pharmacies and the health system to facilitate the sharing of patient records.

The retrospective analysis of Ireland’s National Covid-19 Vaccination Programme involved stakeholder engagement, the review of 246 documents, as well as interviews with 11 senior policy-makers in the Government and various parts of the health system.

Epicentre of primary care

Lead author Aaron Koay, who conducted the research while undertaking an MSc in Comparative Social Change in the School of Social Sciences and Philosophy in Trinity, explained: “During the height of the Covid-19 pandemic, community pharmacies became the epicentre of primary care in Ireland when most health services, including GPs, switched to remote care.

“However, unlike some other high-income countries, community pharmacies in Ireland were involved

relatively late in the Covid-19 vaccination programme — four months after GPs were engaged. This delay was even more puzzling since community pharmacies in Ireland had been providing various vaccination services for almost a decade, including the annual flu vaccine.”

The authors said their research identified differing views on the reasons why there was such a delay in community pharmacists providing Covid-19 vaccination. Some attributed it to regulatory and logistical challenges, while others cited perceived doubts about the capability of community pharmacies to effectively and safely vaccinate the public, they said.

“The study also highlights the lack of strategic direction within the pharmacist profession and lack of influence on national health policy,” Mr Koay continued. “For example, the Chief Pharmaceutical Officer post in the Department of Health has been vacant since 2013 and no pharmacy representative was present on the High-level Task Force on Covid-19 Vaccination.”

Window for change

The research publication comes at a time when there is an important window for policy changes, according to the authors, with the formation last year of a review panel to evaluate the Government’s Covid-19 response.

The missed opportunity to engage community pharmacies earlier in providing Covid-19 vaccination to save lives should be part of the evaluation,

advised the authors. While the Irish Government has recently committed to expanding the role of pharmacists in Ireland, the authors also cautioned against complacency because, as this research reveals, policy implementation can be obstructed or delayed, they said.

‘Political process’

Dr Camilla Devitt, Associate Professor in Sociology in the School of Social Sciences and Philosophy, added: “Our research is the first of its kind in the pharmacy practice sphere in Ireland. Through interviewing key policy elites and reviewing extensive documentary sources, we found that the implementation of community pharmacy-based Covid-19 vaccination in Ireland was far more than a technical exercise — it was a highly political process that involved several stakeholders and interests.

“Our research, like other previous studies, shows that the Irish health system is shaped by a diverse range of competing ideas, interests and institutions. Multi-method qualitative analyses like this one can reveal the closed, intricate workings of health policy-making to inform change towards better public health."

The full paper, ‘What Obstructs Health Policy Implementation? A Multi-Method Qualitative Case Study of the Delayed Deployment of Community Pharmacies in Ireland’s National Covid-19 Vaccination Programme’ can be viewed at https://journals.sagepub.com/ doi/10.1177/10497323241302239. ●

Nomination process now open for registered pharmacist appointments to the PSI Council

 Registrar Joanne Kissane encourages registered pharmacists to consider nomination

 Five positions for pharmacists will be available

There will be five pharmacists completing their current terms as Council members with the PSI in June this year. The nomination process to appoint new pharmacist members is now open, said the Society.

Registrar and Chief Officer of the PSI, Joanne Kissane, herself a pharmacist and former Council member, encouraged PSI-registered pharmacists interested in making a public service contribution to consider the information available about the role. The nomination period is open until midday on Wednesday, 19 March.

Backgrounds

The PSI Council is the governing body of the regulator. The 21 members, all appointed by the Minister for Health in the public interest, are collectively responsible for the delivery and implementation of the regulator’s strategy and for ensuring that the PSI fulfills its statutory remit. The Council is made up of people from a variety of backgrounds who come to serve on the Council via a variety of routes. The process of selecting pharmacist members, who make up 10 of the 21 members, is prescribed in legislation.

The PSI is keen to see that the Council is representative of society, which in turn is reflected in the diversity of the Pharmacist Register, which currently stands at over 7,700 pharmacists.

The Council has recently approved its strategy for 2025-2028. The Council will oversee the delivery of this strategy and the work of the PSI during what will be a period of significant change for pharmacy and the healthcare landscape. Among other things, expanded scope of practice as well as digital health changes are on the agenda. It is imperative that the Council has the expertise, experience and objective scrutiny available to support decisionmaking that places patient and public safety at its centre, while stewarding the ongoing evolution of the ways that the PSI meets its regulatory functions, said the Society.

The vacancies occurring for pharmacist members are those currently held by Mr John Given, Ms Katherine Morrow, Mr Rory O’Donnell, Ms Marie

Louisa Power, and Mr Sean Reilly, whose terms of office end on 20 June 2025.

Nomination

Interested pharmacists will find information about the role of a Council member, criteria for appointment and the nomination form on the PSI website, www.psi.ie. Nominees and their proposers must be on the PSI Register of Pharmacists.

An election will be held on 16 April if the nominations exceed the five vacancies available. All registered pharmacists are eligible to vote in the election and will be issued a ballot paper by post in early April.

Pharmacists are encouraged to check that their postal address is upto-date on the PSI Registration Portal (https://registrations.thepsi.ie/ ) in order to receive their election post. ●

Next-generation pharmacy

The Irish Institute of Pharmacy (IIOP) hosted a parallel session titled ‘Next Generation Pharmacy’ as part of the 2025 Royal College of Surgeons in Ireland (RCSI) Charter Week Meeting. The theme of this year’s Meeting was ‘Next Generation Surgery’

The IIOP welcomed key stakeholders from the pharmacy profession, and a pharmacy student who presented on different aspects relating to the future of pharmacy and who took part in an engaging and interactive panel discussion. There were over 100 registrants from all areas of the healthcare setting for the session, which took place in RCSI on 6 February.

Vision

The session explored the vision for the next generation of pharmacy from a range of perspectives, including those of pharmacists across primary and secondary care settings, researchers, and policy-makers at local and national level, all with a patientcentered approach.

In addition, a fourth-year MPharm student presented the student viewpoint in terms of what lies ahead for the upcoming generation of pharmacists. As well as hearing presentations on a range of perspectives and topics, the panel discussion enabled attendees to direct questions to the speakers, bringing together the many strands from the session.

The line-up of speakers included:

 Ms Clare Fitzell, Head of Strategic Policy, IPU.

 Ms Muriel Pate, Chief II Pharmacist, HSE Access and Integration.

 Ms Bríd Ryan, Clinical Lead ePharmacy, HSE.

 Ms Ewurabena Ofosu-Aikins, 4th Year MPharm Student, RCSI.

 Prof Dr Frank Moriarty, Associate Professor, School of Pharmacy and Biomolecular Sciences, RCSI.

 Dr Aisling O’Leary, Senior Lecturer, School of Pharmacy and Biomolecular Sciences, RCSI.

 The session was chaired by Dr Catriona Bradley, Executive Director, IIOP.

The event provided an opportunity to reflect on current pharmacy practice and the progress achieved in Ireland to date, while also offering a platform to envision the future of professional development for the next generation of pharmacist practitioners.

Challenges alongside enablers for building a sustainable pharmacy workforce in both primary and secondary care were presented, in parallel to understanding the impact of increased healthcare capacity and the need to strengthen healthcare systems.

Expansion

How the expansion of the role of the pharmacist and development of advanced specialist pharmacist roles will further support the delivery of optimised care for patients and collaborations with our health system partners was outlined.

The ongoing development of the national IT infrastructure, including an overview of the ePrescribing project and the positive implications for patients and prescribers, reinforced that a systems approach is critical to ensure the highest standards of quality and patient safety in the changing world of healthcare today.

Discussion on personalised medicine outlined applications such as actionable drug-gene interactions, supporting patient counselling, and the development of tools for

risk stratification in deprescribing and medicines optimisation. The importance of ensuring best available evidence was considered, together with patients’ values and clinicians’ judgement in co-designing approaches to such applications in practice was emphasised.

Many aspects of sustainability in practice were presented, anchored on the four principles of sustainability in healthcare. Resources for enablement of building sustainability into pharmacy practice were outlined, including the Medicine Carbon Footprint Formulary. The necessity of integrating sustainability into practice was demonstrated, including an outline of the health co-benefits of climate action.

The session included an overview by a fourth-year pharmacy student of their perspective of how the role of the pharmacist may change in the next 25 years. This vision included improving patient-centered outcomes through the provision of more preventative-focused holistic and integrated care, use of personalised medicines, and increased use of technology — embracing the unfamiliar, as opposed to fearing it.

IIOP competition winners

IIOP also ran an exciting competition as part of the event, inviting pharmacists and pharmacy students from all years to make a submission themed around their vision of what a pharmacists’ role will be in 25 years’ time, the year 2050.

Congratulations to Leon O’Hagan (Pharmacist category) and Laura McCormick (Pharmacy student category) for their winning entries. Each winner received a €200 voucher. ●

Generic Product Launch

Fingolimod Teva

0.5 mg hard capsules fingolimod

High Tech Prescription Medicine

Indications

Fingolimod Teva 0.5 mg hard capsules

Fingolimod Teva is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:

Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see the SmPC) or

Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Fingolimod Teva Hard Capsules Abbreviated Prescribing Information

Presentation: Each hard capsule contains 0.5mg fingolimod as hydrochloride. Indications: Fingolimod Teva is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis (MS) for adult patients and paediatric patients (10 years and older) with: Highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy; Or with rapidly evolving severe relapsing remitting MS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI. Dosage and administration: For oral administration. Treatment should be initiated and supervised by a physician experienced in MS. Adults: The recommended dose is one 0.5mg capsule taken orally once daily. Children (10 years of age and above): The recommended dose is dependent on body weight. Paediatric patients with body weight ≤40kg: one 0.25mg capsule taken orally once daily. Paediatric patients with body weight >40kg: one 0.5mg capsule taken orally once daily. Paediatric patients who start on 0.25mg capsules and subsequently reach a stable body weight above 40kg should be switched to 0.5mg capsules. The safety and efficacy of fingolimod in children aged below 10 years has not been established. Elderly: Fingolimod Teva should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy. Renal impairment: No dose adjustments are needed in patients with mild to severe renal impairment. Hepatic impairment: No dose adjustment needed in patients with mild or moderate hepatic impairment, but caution should be exercised when initiating treatment in these patients. Fingolimod Teva must not be used in patients with severe hepatic impairment (Child-Pugh class C). Contraindications: Immunodeficiency syndrome. Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies). Severe active infections and active chronic infections (hepatitis, tuberculosis). Active malignancies. Severe liver impairment (Child-Pugh class C). Patients who in the previous 6 months had myocardial infarction (MI), unstable angina pectoris, stroke/ transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure. Patients with severe cardiac arrhythmias requiring anti-arrhythmic treatment with class Ia or class III antiarrhythmic medicinal products. Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV block, or sick-sinus syndrome, if they do not wear a pacemaker. Patients with a baseline QTc interval ≥ 500 msec. During pregnancy and in women of childbearing potential not using effective contraception. Hypersensitivity to the active substance or to any of the excipients. Precautions and warnings: Initiation of treatment results in a transient decrease in heart rate (HR) and may also be associated with AV conduction delays, including the occurrence of isolated reports of transient, spontaneously resolving complete AV block. All patients should have an electrocardiogram (ECG) and blood pressure measurement performed prior to and 6 hours after the first dose of Fingolimod Teva. All patients should be monitored for a period of 6 hours for signs and symptoms of bradycardia with hourly HR and blood pressure measurement. Continuous ECG monitoring during this 6 hour period is recommended. The same precautions as for the first dose are recommended when patients are switched from the 0.25mg to the 0.5mg daily dose. In the event of post-dose bradyarrhythmia-related symptoms, initiate clinical management and monitor the patient until the symptoms have resolved. Very rare cases of T-wave inversion have been reported in adult patients treated with fingolimod. In case of T-wave inversion, the prescriber should ensure that there are no associated myocardial ischaemia signs or symptoms. If myocardial ischaemia is suspected, seek advice from a cardiologist. Fingolimod Teva should not be used in patients with sino-atrial heart block, a history of symptomatic bradycardia, recurrent syncope or cardiac arrest, or in patients with significant QT prolongation, uncontrolled hypertension or severe sleep apnoea. Fingolimod has an immunosuppressive effect that predisposes patients to an infection risk, including opportunistic infections that can be fatal, and increases the risk of developing lymphomas and other malignancies, particularly those of the skin. Before initiating treatment with Fingolimod Teva, a recent complete blood count (CBC) (i.e. within 6 months or after

Teva Pharmaceuticals Ireland, Digital Office Centre Swords, Suite 101 - 103, Balheary Demesne, Balheary Road, Swords, Co Dublin, K67E5AO, Ireland.

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Prescription Only Medicine.

discontinuation of prior therapy) should be available. Assessments of CBC are also recommended periodically during treatment, at month 3 and at least yearly thereafter, and in case of signs of infection. Absolute lymphocyte count <0.2x109/l, if confirmed, should lead to treatment interruption until recovery. Initiation of treatment with Fingolimod Teva should be delayed in patients with severe active infection until resolution. Suspension of Fingolimod Teva should be considered if a patient develops a serious infection and consideration of benefit-risk should be undertaken prior to re-initiation of therapy. Patients should report symptoms of infection up to 2 months after discontinuation of fingolimod. Serious, life-threatening, and sometimes fatal cases of encephalitis, meningitis or meningoencephalitis caused by herpes simplex and varicella zoster viruses have occurred with Fingolimod Teva. Treatment should be stopped if these develop, and appropriate treatment initiated. Patients need to be assessed for their immunity to varicella (chickenpox) prior to treatment. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment. Cases of cryptococcal meningitis, sometimes fatal, have been reported after approximately 2-3 years of treatment. If cryptococcal meningitis is diagnosed, fingolimod should be suspended and appropriate treatment should be initiated. Progressive multifocal leukoencephalopathy (PML) has been reported under fingolimod treatment. Before initiating treatment with fingolimod, a baseline MRI should be available (usually within 3 months) as a reference. MRI findings may be apparent before clinical signs or symptoms. If PML is suspected, MRI should be performed immediately for diagnostic purposes and treatment with fingolimod should be suspended until PML has been excluded. Due to the immunosuppressive properties of fingolimod, vaccination against Human papilloma virus (HPV) should be considered prior to treatment initiation. Macular oedema has been reported in patients treated with fingolimod 0.5mg. Perform an ophthalmological evaluation 3–4 months after fingolimod initiation. Evaluate the fundus, including the macula, in patients reporting visual disturbances. Fingolimod Teva should be discontinued if a patient develops macular oedema. Increased hepatic enzymes have been reported in MS patients treated with fingolimod. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have occurred as early as ten days after the first dose and have also been reported after prolonged use. Do not use fingolimod in patients with severe pre-existing hepatic injury (Child-Pugh class C). Due to the immunosuppressive properties of fingolimod, initiation of treatment should be delayed in patients with active viral hepatitis until resolution. Recent (i.e. within last 6 months) transaminase and bilirubin levels should be available before initiation of treatment. If liver transaminases are at least 5 times the upper limit of normal (ULN) or at least 3 times the ULN associated with any increase in serum bilirubin, Fingolimod Teva should be discontinued. Blood pressure should be regularly monitored during treatment as Fingolimod Teva can cause hypertension. Fingolimod Teva should be used with caution in patients with severe respiratory disease, pulmonary fibrosis and chronic obstructive pulmonary disease. Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported during treatment. If PRES is suspected, Fingolimod Teva should be discontinued. When switching patients from another disease modifying therapy to Fingolimod Teva, a CBC is recommended prior to initiating treatment to ensure that immune effects of the previous therapy have resolved. Vigilance for skin lesions is warranted and a medical evaluation of the skin is recommended at initiation, and then every 6 to 12 months taking into consideration clinical judgement. Patients should be referred to a dermatologist in case suspicious lesions are detected. Patients treated with fingolimod should be cautioned against exposure to sunlight without protection. If lymphoma is suspected during treatment, Fingolimod Teva should be discontinued. Rare cases of tumefactive lesions associated with MS relapse have been reported. Severe exacerbation of disease has been observed rarely in some patients stopping fingolimod. Caution is therefore indicated when stopping fingolimod therapy. If a decision is made to stop treatment with fingolimod a 6-week interval without therapy is needed, based on half-life, to clear fingolimod from the circulation. Caution is indicated with the use of immunosuppressants soon after the discontinuation due to possible additive immune system effects. The safety profile in paediatric patients is similar to that in adults. Cases of

seizures, anxiety, depressed mood and depression have been reported with a higher incidence in paediatric patients treated with fingolimod compared to patients treated with interferon beta-1a. It is recommended that paediatric patients complete all immunisations in accordance with current immunisation guidelines before starting Fingolimod Teva. Interactions: Anti-neoplastic, immunomodulatory or immunosuppressive therapies should not be co-administered due to the risk of additive immune system effects. During and for up to two months after treatment vaccination may be less effective. The use of live attenuated vaccines may carry a risk of infections and should be avoided. Treatment with Fingolimod Teva should not be initiated in patients receiving beta-blockers, or other substances which may decrease HR, such as class Ia and III antiarrhythmics, calcium channel blockers (such as verapamil or diltiazem), ivabradine, digoxin, anticholinesteratic agents or pilocarpine. Coadministration of fingolimod with ketoconazole resulted in a 1.7-fold increase in fingolimod and fingolimod phosphate exposure (AUC) by inhibition of CYP4F2. Caution should be exercised with substances that may inhibit CYP3A4 (protease inhibitors, azole antifungals and some macrolides such as clarithromycin or telithromycin). Co-administration of strong CYP3A4 inducers (rifampicin, phenobarbital, phenytoin, efavirenz) should be used with caution as they may reduce the AUC or fingolimod and its metabolite. Concomitant administration with St. John’s Wort is not recommended. Co-administration of fingolimod with oral contraceptives (ethinylestradiol and levonorgestrel) did not elicit any change in oral contraceptive exposure. Pregnancy and lactation: Fingolimod is contraindicated in women of childbearing potential not using effective contraception. Post-marketing data suggest that use of fingolimod is associated with a 2-fold increased risk of major congenital malformations when administered during pregnancy compared with the rate observed in the general population. Women of childbearing potential should provide a negative pregnancy test result before treatment initiation and must receive counselling regarding the serious risk to the foetus. Effective contraception must be used during treatment and for 2 months after discontinuation of Fingolimod Teva. Fingolimod should be stopped 2 months before planning a pregnancy. If a woman becomes pregnant during treatment, fingolimod must be discontinued. When stopping fingolimod therapy for planning a pregnancy the possible return of disease activity should be considered. Women receiving Fingolimod Teva should not breastfeed. Effects on ability to drive and use machines: Has no or negligible influence on the ability to drive and use machines, however, dizziness or drowsiness may occasionally occur when initiating treatment. Adverse reactions: Pneumonia, progressive multifocal leukoencephalopathy (PML), cryptococcal infections, basal cell carcinoma, malignant melanoma, lymphoma, squamous cell carcinoma, Kaposi’s sarcoma, leucopenia, thrombocytopenia, autoimmune haemolytic anaemia, hypersensitivity reactions, seizure, posterior reversible encephalopathy syndrome (PRES), macular oedema, bradycardia, ECG T-wave inversion and acute hepatic failure. Very Common: Influenza, sinusitis, headache, cough, diarrhoea, back pain and increased hepatic enzyme levels. Common: Herpes viral infections, bronchitis, tinea versicolor, lymphopenia, depression, dizziness, migraine, blurred vision, AV block, hypertension, dyspnoea, eczema, alopecia, pruritus, myalgia, arthralgia, asthenia, decreased weight and increased blood triglyceride levels. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: If an overdose constitutes first exposure to fingolimod, it is important to monitor patients with a continuous (real time) ECG and hourly measurement of HR and blood pressure, at least during the first 6 hours. If after 6 hours the HR is <45bpm in adults, <55bpm in paediatric patients aged 12 years and above, or <60bpm in paediatric patients aged 10 years to below 12 years, or if the ECG at 6 hours after the first dose shows second degree or higher AV block, or if it shows a QTc interval ≥500msec, monitoring should be extended at least for overnight and until the findings have resolved. The occurrence at any time of third degree AV block should also lead to extended monitoring including overnight monitoring. Neither dialysis nor plasma exchange results in removal of fingolimod from the body. Legal category: POM Marketing Authorisation Number: PA0436/047/001. Marketing Authorisation Holder: Norton Waterford, T/A IVAX Pharmaceuticals Ireland, Unit 301, IDA Industrial Park, Cork Road, Waterford, Ireland Job Code: MED-IE-00050. Date of Preparation: February 2022.

A matter of space and time

Fintan Moore applies Einstein’s theory to some problems in the dispensary

Throughout history, the greatest scientific minds have grappled with the mysteries of matter, space and time.

I think there’s a consensus that the universe is still expanding from its Big Bang origins, but I don’t know what it’s expanding into; and there is also the question of whether or not time is fixed and linear, or subject to change depending on other factors. Einstein once said that people used to believe that if all matter disappeared, time would still continue, but he contended that if matter disappeared, then time would disappear with it.

Whatever is happening out in the cosmos, there are definitely strange forces at work in dispensaries which lend weight to Einstein’s theory. If Einstein was wrong, then time and space should be unaffected by changes in matter, but we see strong evidence every day that the opposite is true, because as the level of matter, ie, prescriptions increases, we end up working in an ever-smaller space with an ever-shrinking amount of time. There are confounding variables that affect all of this. The volume of prescription matter is not always a good measure of the resulting effort required to process it, because the density of the prescriptions has to be taken into account. Even density itself can be complicated due to the different interpretations of the word.

The Covid-times joke about the spread of the virus comes to mind, which said that the spread of the virus increased with the density of

prosecuted, the penalties are ridiculously short, and often fully suspended.

Pharmacies are a happy hunting-

the problem because they just want the stock to ‘move’, regardless of whether or not it gets paid for before moving.

Why ‘talking to the animals’ might pay pharmaceutical dividends

Dr Des Corrigan examines what we can learn from animals treating themselves for injuries

Last year, I was intrigued by a story about an orangutan in Sumatra that had used a plant paste to heal a facial wound. This story did not quite go viral, but it certainly caught a fair bit of media attention as it was followed up by articles in outlets such as The Conversation and the Smithsonian Magazine describing what is meant by the term ‘Zoopharmacognosy’ — in other words, the study of medicinal plants used deliberately by animals to cure themselves.

Now, this is not a new term, dating back as it does to 1993, nor is the underlying concept new either, as Aristotle and Pliny among others highlighted the benefits to humans of observing what plants are chosen by animals when they are ill. It has also been suggested that both khat and coffee were discovered after changes in the behaviour of goats who had consumed these stimulant-containing plants was noticed by herdsmen. While that was millennia ago, those at the forefront of studies in this area believe that new life-saving drugs can yet be discovered by careful observation of animal behaviour.

The research that started the current wave of interest appeared in Nature Scientific Reports last year. It reported on a male Sumatran orangutan with a facial wound who was seen by the researchers to selectively chew the leaves of a liana (a woody vine). The animal first applied the juice to the wound and then covered it with the

chewed leaves. Three weeks later, the facial wound was seen to be fully healed in what the authors claimed to be the first systematic documentation of apparently active wound treatment with a biologically active plant in great apes.

The plant in question was identified as Fibraurea tinctoria, and that last part of its Latin name indicates that this plant has a history of use as a dye (yellow in colour). According to a 2008

paper in Bioorganic and Medicinal Chemistry, it is widely used in folk medicine in China and South-East Asia in the treatment of dysentery and for analgesic, antipyretic, diuretic and antimalarial (especially in Vietnam) effects. The plant was found to contain protoberberine alkaloids and furano-diterpene derivatives, known inevitably as fibraruretins. Two of these had significant anti-inflammatory

activity in the carrageenan-mouse paw oedema test, whereas five others were potent nitrous oxide production inhibitors. In addition, both the alkaloids and the terpenoids are known to be antibacterial, which would also be relevant to wound healing.

The first fully documented case of an animal self-medicating with a plant involved chimpanzees in western Tanzania, who were observed consuming the bitter juice from the pith of a plant called Vernonia in order to expel worm infestations. The chimps only used this plant at times of peak worm infestation during the rainy season, when they had to actively seek out the plant due to its uneven distribution. Scientific studies have shown that the plant contains bitter sesquiterpene lactones with antibacterial activity. More pertinently it has been shown to have anthelminthic, anti-malarial and tumour-growth inhibitory effects in the lab.

Not all of the research involves nonhuman primates, as pointed out in a 2022 Planta Medica review of 14 case studies of plant medicines inspired by observation of animals as diverse as llamas, reindeer and porcupines. In the latter case, observation by a local traditional healer of a porcupine in Tanzania eating the roots of particular plant led to the successful use of the plant by that healer to treat STIs as secondary infections in AIDS patients. There is little information on this plant, but a related species has been shown to produce an antibacterial essential oil, according to a 2024 paper in Molecules. There is another aspect to the plant — animal interaction, as described in a June 2024 article in the Smithsonian Magazine. In it, the author describes how various animals consume a poisonous diet in order to defend themselves against predators. Among the classical examples of this are the Monarch butterflies, the caterpillars of which feed on Milkweed plants that are rich in digoxin-like cardiac glycosides. The adult butterflies store the toxic glycosides to

deter predators, and their characteristic black and orange colouring is a signal of this toxicity. Unfortunately for the butterfly, one species of predatory mouse and a bird have evolved mutations that allow them tolerate the toxins when they eat the insects.

The other classical example is of course the poisonous tree frogs from South America that are also highly coloured as a warning sign to predators. These frogs obtain their toxins from ants, beetles and termites that constitute their diet. Some species contain an alkaloid called Epibatidine that is 200 times more potent than morphine, although the lethal and effective doses are far too close for

The other classical example is of course the poisonous tree frogs from South America

comfort. One derivative (ABT-594) or Tebanicline did get as far as Phase 2 clinical trials, but dangerous GIT effects apparently led to it being dropped from further study. However, this does show the potential of zoopharmacognosy in pointing towards new drugs with novel mechanisms of action, because the frogderived alkaloids were found to exert analgesic effects through their role as nicotinic acetylcholine receptor agonists.

Another species of South American frog contains batrachotoxin, as does the pitohui bird from the New Guinea rainforest. This is a steroidal alkaloid that is 250 times more toxic than strychnine and has both neurotoxic and cardiotoxic effects. Initially, it was believed that the toxin originated in beetles upon which the frogs fed, until it was realised that the beetles in question could not synthesise the steroid nucleus,

meaning that some as-yet unidentified organism further down the food chain was the source of the toxin. As a number of authors have pointed out, most natural product research has been concentrated on the half-million or so plant species that are estimated to exist on our planet, whereas the chemistry of the several million species of insects is largely unexplored.

A 2022 review in the American Journal of Primatology notes that self-medication is best documented in African primates, but points out that the great diversity of both plants and animals in the tropics and elsewhere suggests that many medicinal species might still be discovered by studying animal self-medication and protection. I have the strong feeling that a huge proportion of drug discovery budgets are nowadays focused on large molecules, but I remain convinced that there is still potential in clinical practice for small molecules, be they synthetic or natural. So, saving the plants and the animals that could save lives continues to make sense. ●

Dr Des Corrigan, Best Contribution in Pharmacy Award (winner), GSK Medical Media Awards 2014, is an Adjunct Associate Professor at the School of Pharmacy and Pharmaceutical Sciences at TCD where he was previously Director and won the Lifetime Achievement Award at the 2009 Pharmacist Awards. He was chair of the Government’s National Advisory Committee on Drugs from 2000 to 2011, having previously chaired the Scientific and Risk Assessment Committees at the EU’s Drugs Agency in Lisbon. He chaired the Advisory Subcommittee on Herbal Medicines and was a member of the Advisory Committee on Human Medicines at the HPRA from 2007 to 2024. He has been a National Expert on Committee 13B (Phytochemistry) at the European Pharmacopoeia in Strasbourg and served on the editorial boards of a number of scientific journals on herbal medicine.

No smoke without fire

Does the free NRT scheme mean employee pharmacists now have another service to advise on, with no increase in pay, writes Áine Mac Grory

I’m almost two months into 2025. It’s been a tough start to the year, but I take comfort from my patients who, while disappointed, were sympathetic towards my plight and as annoyed as me about the misleading not-so-‘free’ HRT scheme. Every interaction so far has been met with responses of ‘but how can they expect you to just take the hit; that’s not fair?’, and they’re right. It isn’t fair. I have managed to stamp-out those little fires within my patient cohort at least.

The issue continues to be discussed in the media, with a negative light being shone on the community pharmacy sector and no retaliation from our side.

The new MfH (Minister for Health) spoke in the Dáil recently to address the implementation delay. There, she stated: “The Government set aside money to pay for the products but not the dispensing fee for pharmacists. I have met the pharmaceutical union. I am engaging with it to see if there is something we can do, but the reality is we do not have the budget to carry the dispensing fees… I am trying to find a resolution… I hope the pharmaceutical union will come back with something we can work on.”

I guess this means she didn’t like the idea of the proposed integrated women’s healthcare scheme that was sent to the Department.

Then comes 29 January. All snuggledup for the night and ready to get stuck into the IIOP’s webinar, titled ‘Stop Smoking Medicines & HSE Stop Smoking Services’. What more could you want of a Wednesday evening?

Fast-forward 40 minutes.

So frozen am I with shock and confusion that I can barely pick my jaw up off the floor.

Did I just hear that correctly? I must

be mistaken. I gather myself and see my phone lighting up like a Christmas tree. An explosion of angry emojis and ‘what did I just watch?’, and ‘anyone need their blood pressure checked after that webinar?’

The discontent was stemming from the part of the webinar where the question was put to the presenter: "… if I have a patient come in, how can I get them access to that free NRT?"

The response: ''If you have anybody that’s coming in and looking for free NRT, advise them to come into the stop smoking service... we will arrange for the stop smoking medications to be either posted out to them or through their participating pharmacy they go and get it that way, so that’s the way they get the medication… right now you can email… and get the referral to us and we’ll start engaging with

the client on that point.’’

On the surface, it doesn’t seem like much, but when you consider what that means, it is extremely concerning.

The pharmacists in attendance at that webinar have been instructed to essentially block a sale/dispensing of an NRT product and instead inform the patient of this service, collect and forward on their details through Healthmail, and direct the patient to the nearest clinic.

Assuming the patient does attend this clinic, they will then potentially be sent to a participating pharmacy. That sounds an awful lot like an administrative task and an unpaid referral. There was no mechanism discussed for the claiming of a referral fee.

From the community pharmacist side, it looks like new services are being brought

into chains via a loophole and bypassing the independents. The employee pharmacists now have another service to advise on, with no increase in pay.

I fear this method will be used to resolve other service provision hurdles.

Are we at risk of the work-around for free HRT scheme being a referral to the nearest menopause management clinic? Where they receive resources, support and a signpost to collect their free HRT products from a participating pharmacy? Making this another tender process that any pharmacy can partake in, but that realistically only a chain will have the capability to provide.

The IPU members turned to their union to do something. A video message was sent out to address these concerns — “The tender announced is a short-term measure and the HSE QUIT team have clearly stated an intention to provide the service through all community pharmacies.”

An intention? Remind me again, what was the road to hell paved with?

I recall in September 2023, the journal. ie reported: “In a matter of weeks, the cost of nicotine replacement chewing gums, patches and lozenges will be capped at €80 a month under new plans being devised by Health Minister Stephen Donnelly.”

August 2024 – Free HRT for the women of Ireland by January 2025.

One could be forgiven for not holding out hope that in 12 months’ time, free NRT will be brought into all pharmacies, based on the track record of intentions to date.

There is a very concerning precedent being set.

I have taken time out daily to explain the current situation to patients asking about a prescription extension and the reason for not implementing, as per the instruction given by my union.

The same union are now saying in this instance, the decision to run and publish the HSE QUIT tender process is a matter for the HSE and any individual community pharmacy that wishes to engage with that tender process or not.

I wanted to engage with the tender process but when the invitation to tender for this service came out, It was clear from

the eligibility criteria* that an independent pharmacy was never going to stand a chance at winning that contract.

It doesn’t matter what branch of the HSE this service is coming from. The public doesn’t know the difference. It is blurring the message coming from the IPU with regards to no more engagement with new services until substantial work has been made on the pay claim.

Why should I continue to withhold on prescription extension and expansion of the pharmacy role, when the people being tasked to implement IPU strategy are engaging in new services? You lead by example. How weak does my discussion at the counter become when a chain is allowed to provide a nationwide service, but I must send my patient back to their GP to get their six-month script renewed?

I lose the chance to engage with my patient and if I refer them on, I am at risk of losing them entirely, because why would anyone opt to collect only their NRT from one pharmacy and then attend a different one for their prescriptions?

Do I engage in this unpaid referral process? And if I don’t, how does it look for me knowing a patient can get their gum free elsewhere?

It is sending mixed messages.

I saw this as an opportunity of leverage for the community pharmacy sector. The future of pharmacy is service-driven. A strike is not feasible, but halting the progress of a very worthwhile health incentive is. Make it clear to the HSE that we have some power over the implementation and success of these kinds of projects. This could have been a chance at unity. Employees, independents and chains displaying a show of solidarity.

We are being rinsed in the media. There has been no progress shared to date, just acknowledgment of many attempts.

Fine — allow the tender to go ahead if it can’t be paused, but support and advise all non-participating pharmacies to stall referrals until that service has had a fee agreed AFTER substantive progress has been made in the pay claim.

We are up to our proverbial in schemes overlapping other schemes, with

patients eligible for more than one. The simple solution is to include NRT on the DPS scheme and, like the emergency contraceptive scheme, issue a code for a stop-smoking service referral when patient details are sent to a stop-smoking clinic. The patient can attend their pharmacy and get the stop-smoking products without delay. This eliminates any need for any tender process and incorporates all community pharmacies instantly. Everything else from the stop-smoking service remains the same and the patient gets all the extra support they need through the clinics. How disempowered are the non-participating pharmacies otherwise?

I am well able to counsel and support my patients on their stop-smoking journey. Why should I lose the opportunity to make that contact count and have a meaningful engagement with my patient? Why should I lose the sale of my OTC NRT? Why am I once again writing an article about another replacement therapy scheme damaging the integrity of the community pharmacy sector? ●

*‘The Service Provider must be a National Supplier(s) with a nationwide pharmacy presence/partnership with strong logistics network/logistics partnerships. The Mandatory requirement is that the provider has a pharmacy location within 15km radius of a minimum of 91 different Stop Smoking Clinic locations nationwide (approx. 60%) in order to provide a minimum nationwide geographical spread.’

Áine is a Superintendent Pharmacist and pharmacy owner with over 18 years of experience working in community pharmacies across Ireland. In 2014, she earned her Master of Pharmacy (MPharm) degree in the UK. Her career journey has encompassed a variety of roles, including locum, support, and supervising, culminating in her recent transition to pharmacy ownership. She is deeply committed to upholding the integrity and vital role of community pharmacy in Ireland, combining her extensive experience with a passion for patient care and professional excellence.

Innovation in Healthcare Podcast Series

Presented by Priscilla Lynch

SCAN HERE TO LISTEN

EPISODE 2

An interview with Prof Derek O’Keeffe

EPISODE 4

An interview with Prof Doug Veale*

EPISODE 6

An interview with Prof Dominic A. Hegarty

EPISODE 3

An interview with Prof Orla Hardiman

EPISODE 5

An interview with Prof Mary Horgan

EPISODE 7

An interview with Prof Mark Lawler & Prof William Gallagher

*Prof Doug Veale passed away in May 2024

The challenge of ADHD

Terry Maguire examines the increasing diagnoses of ADHD and wonders if the medical world is taking the right approach

Methylphenidate shortage I am, like most pharmacists, getting around four calls a week looking for methylphenidate. There has been an irritating shortage of methylphenidate medicines recently, mostly for the slow-release formulations, as manufacturers struggle to satisfy demand. Those contacting me are often adult patients, as many people are now being diagnosed with ttention Deficit Hyperactivity Disorder (ADHD) in adulthood, whereas in the past, the condition was mainly diagnosed in children.

The NHS waiting list for an ADHD referral is something in the region of seven years, so it is not surprising that many who think they might have the condition are seeking an assessment from private practitioners. However, this can then create conflict with GPs unwilling to accept a diagnosis from a private practice if they are being asked to prescribe controlled drugs with some potentially significant sideeffects. One GP told me he hasn’t found a private practice that did not make a confirmed diagnosis.

Since 2015, the prevalence of ADHD in the UK has tripled. Such a large increase begs the question, why? One thing you should never do is suggest that ADHD is a made-up condition, as there is little doubt people experience symptoms that are sufficiently severe to impair personal development and normal social functioning — but do these symptoms always justify an ADHD diagnosis? There is also a view that an ADHD diagnosis provides a label, a type of ‘get-out-ofjail-free card’ that closes off individuals from the idea of change — the simpler solution — when change might be what is needed.

The anxious generation

Technology is being blamed, and certainly might be an explanation in children and young adults who live online, bombarded with constant stimulation. Jonathan Haidt in his recent bestseller The Anxious Generation references studies that show young adults who are constantly stimulated by social media are more likely to have a diagnosis of ADHD.

Attention is a key element of a healthy pre-frontal cortex, the last part of the brain to develop. Attention is fragmented by constantly altering stimuli and the child becomes unable to make and execute plans. It is the curtailing of social media, especially smartphones, that is needed, according to Haidt, not daily doses of stimulant drugs. Indeed, Australia has recently taken the step of becoming the world’s first country to ban social media for the under-16s, while many UK schools have sought to ban smartphones, yet it’s too early to say if or how this will impact on the prevalence of ADHD.

Diagnosis

The Diagnostic and Statistical Manual of Mental Disorders, fifth edition, or the DSM-5 , is the definitive guide on mental

disorders for healthcare professionals in the US and much of the world. Since the 1980s, it has provided clinicians with diagnostic criteria for ADHD, but it was only in 2013 that it updated its definition of ADHD to include adult ADHD.

Before the mid-1980s, ADHD didn’t really exist, certainly as a diagnosis, but children with challenging behaviours did and, indeed, in those years I had one of them myself. I did often look at this tender child and wonder what made him do the things he did. It never entered my head that he could be suffering from a mental health condition, let alone want to seek out medicines that might ‘normalise’ his behaviour. Thirty years on, I don’t feel any guilt that we were negligent or failed him. On the contrary, I am proud to say he has grown into a totally responsible adult, has married, taken on a mortgage, and holds down an impressive job in IT. Had we presented him to a competent psychologist or psychiatrist, he might well have been given an ADHD diagnosis and spent his childhood on Ritalin.

The symptoms currently listed are inattention, poor planning, hyperactivity, short attention span, and impulsivity. These must be pervasive, which means the patient must have these in all settings — at home, at school, at play. My son would have ticked all these boxes. But should his behaviour have been pathologised? Or was he just an outlier in the behaviours that make up the human condition?

In our capitalist society, there is always a tendency to find new markets, and ADHD has offered up a goldmine for private practitioners. Also, and interestingly, there has never been a stigma associated with an ADHD diagnosis the way there can be with other mental health conditions. Indeed, many social influencers and celebrities are happy to wear the label. Perhaps it might explain some of the things they do.

We have three things converging: First, a broader and looser diagnosis; second, diagnosis creep — doctors find it easier to diagnose; and third, medicines to treat the condition.

A number of high-profile doctors have expressed concern about the surge in ADHD diagnoses. These include Prof Simon Wessely, former President of the Royal College of Psychiatrists, Dr Iona Heath, former President of the Royal College of GPs, and Dr Max Pemberton, psychiatrist and medical writer. They point out that it is a doctor’s responsibility to resist the drive to over-diagnose and overtreat patients. It is suggested other health professionals remain quiet, fearful of a backlash from social media.

Anyone can complete an ADHD questionnaire online. This I have done. It asks ‘Am I easily distracted?’ Well, yes. ‘Am I often late for meeting appointments?’ ‘Do I regularly forget appointments?’ Yes, yes, and yes. By the end of this 20-minute questionnaire, I was getting an appointment and being reassured that my problems would soon be over. I challenge any pharmacist working as we do in daily chaos to successfully avoid an ADHD diagnosis from this questionnaire.

The medicines

With a diagnosis comes the prescription. We don’t see atomoxetine, clonidine, or guanfacine prescribed so much, as they are non-stimulant and therefore don’t seem to work as well. The latter two are pharmacologically very similar, their main mechanism of action is an agonistic effect at alpha-2 adrenergic receptors throughout the brain. In the brain stem, alpha-2 agonists lead to a reduction in peripheral vascular resistance and consequently lower blood pressure. This has been the traditional role of alpha-2 agonists and a main cause of side-effects when used in children.

The mainstay of treatment is the psychostimulants — amphetamines and methylphenidate. Stimulant actions include the inhibition of dopamine and noradrenaline transporters at the synapses increasing the concentration of these

neurotransmitters. By enhancing the impact of dopamine and noradrenaline, psychostimulants increase the efficiency of prefrontal cortex activity and optimise executive and attentional function in patients suffering from ADHD. However, the evidence on benefits and harms is, to say the least, uncertain.

In one meta-analysis, out of 212 trials assessed, 191 were deemed to be at high risk of bias mainly due to the difficulty blinding the medicines — you can’t get a placebo medicine that gives the same effects.

Methylphenidate compared to placebo may improve teacher‐rated ADHD symptoms on the ADHD Rating Scale (ADHD‐RS), a scale that is highly subjective and therefore prone to significant reporting bias. The minimal clinically relevant difference is considered to be a change of 6.6 points on the ADHD‐RS, and the studies just about get methylphenidate across the line compared to placebo. Oh, and did I mention that most of the studies were sponsored by the drug industry.

Methylphenidate may be associated with an increased risk of adverse events considered non‐serious, such as sleep problems and decreased appetite. However, the certainty of the evidence for all outcomes is very low and therefore the true magnitude of effects remains unclear.

Due to the frequency of non‐serious adverse events associated with methylphenidate, the blinding of participants and outcome assessors is particularly challenging. To accommodate this challenge, an active placebo should be sought and used. It may be difficult to find such a drug, but identifying a substance that could mimic the easily recognised adverse effects of methylphenidate would avert the unblinding that biases current randomised controlled trials. We are therefore told there is a need for further studies.

Other therapy options

Talking therapy has been shown to be as effective as medication in improving ADHD symptoms and overall functioning

levels. However, the NHS currently has less talking therapy options than the medicines. Some studies have shown that fish oils are helpful. Moreover, they are safe and well-tolerated. However, the results of these studies have been mixed — some children get better, others get worse. Omega-3 fatty acids, such as docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), are important for our brain, body, immune system, and heart. We can only get them from food such as oily fish, spinach, and nuts.

Previous studies have found that children with ADHD eat less omega-3-containing food and have less omega-3 so they are also more likely to show symptoms indicating a lack of omega-3, such as eczema, brittle nails, and dry and scaly skin. The commercial success of the ADHD business will grow, and already we are seeing new molecules being investigated for use in this patient cohort. These include cannabis (delta-9-tetrahydrocannabinol plus cannabidiol), memantine, oxytocin, tolcapone, and vortioxetine.

Do we need to rethink?

A practising social worker with 35 years of experience in children and adolescent services has recently commented that he, too, is concerned by the surge in diagnoses. He points out that the vast majority of children in care come from chaotic households and these children were much more likely to be diagnosed and medicated. He did not find the medicines led to much improvement, but he did find improvement with challenging behaviours when carers were able to establish set routines, improve nutrition, and significantly reduce time on electronic devices. Yes, but that requires support, which is also in short supply. ●

Terry Maguire owns two pharmacies in Belfast. He is an honorary senior lecturer at the School of Pharmacy, Queen’s University Belfast. His research interests include the contribution of community pharmacy to improving public health.

Letting go of fear

We should think about ourselves and our staff if we strive to hold on to difficult customers,

writes Ultan Molloy

Ihad a read of a PharmaBuddy thread recently regarding dealing with aggressive patients. It’s a really interesting read and gave plenty of food for thought on possible approaches. The Wild Rover lyrics kept coming to mind for me: “… Such a custom as yours, I can have any day… ” We don’t need every customer that walks through the door. Not everyone is good for our business, our mental health, and indeed that of our team. I know that having debt and trying to pay the bills, and a fear of being unreasonable, all play into the emotions around this. I have opened a pharmacy which had a relatively low turnover vs the bills for several years, and I’ve opened another pharmacy carrying significant debt, often working 60+ hour weeks, so I know how it feels.

Often, it’s the thoughts that can be most exhausting. ‘What if we lose their custom? What if they tell other people? They’ll take all their family’s prescriptions elsewhere?’ I hear you, as I have heard myself thinking like this in the past. This thinking can cause an amount of stress and internal turmoil for a highly self-assured person, and more so for a prolific ruminator like myself.

Lets look at the fears individually. Firstly, what if we lose their custom? Well, flipping this on its head: What is it costing you in terms of your time, stress levels, and your energy? What is it distracting you from? Perhaps cost-out their custom, and put a figure on it. Then apply your gross margin to

the turnover figure. Then put this figure in the context of your monthly turnover, and make a decision. Are you prepared to suck it up for the profit, or do you want to encourage them politely to move elsewhere, where they could be happier with the service they’re receiving? Secondly, will they tell other people? I’d suggest that most people are mainly concerned with themselves and their own

experience. We all have friends, family and acquaintances who we pay very limited heed too. Especially those who have form in this department. I’d suggest we just catch a breath, and think about what you need for yourself and your team.

Thirdly, what is this distracting you from? The 80/20 rule can be applied here. We have limited time and energy. If 20 per cent

of your customers are taking up 80 per cent of your energy, time and resources, then maybe we need to consider where our focus is directed. One could assertively make oneself less available for someone who’s being unreasonable or overly demanding of your time. Respectfully and politely advise on your policies around this, and assert your boundaries.

We should be at our best to promote safe and effective medicine use, serve and support our patients, showing empathy and providing counselling. We cannot allow ourselves to end up enmeshed in someone’s projected childhood trauma, their unreasonable expectations of us and our team, or their inability to respect our boundaries.

This all assumes we of course are being reasonable in the situations that arise. Perhaps a mirror, such as a conversation with a couple of friends, confidants or colleagues, can give you another perspective on the situation. You’ll just have to call it and move on with your life then.

We cannot allow ourselves to end up enmeshed in someone’s projected childhood trauma

I know in the past that I’ve, to my shame, not given my staff the benefit of the doubt, on a ‘bend over backwards’ policy for customer service, born out of a ‘customer is always right’ belief, and a lack of selfassurance. However, one can only bend so far before one breaks. Our team is our company face and deserve your support, and deserve to feel supported in any reasonable and respectful efforts to put a boundary on customers. I know I have lost staff in the past on foot of me having unreasonable expectations of them, and by making repeated pointed demands, and I feel bad about it when I think back. I wish I had behaved differently. However, every day is a school day, and managing my own stress and anxiety isn’t always easy. We were discussing one’s mental health and overall levels of happiness last week. “Some people just have to work harder at it,” my wife Laura said to me. How true is that! We never know fully, of course, what’s

going on in the lives of others. We have had a number of suicides over the last few months, as have many communities throughout the country. As about 40 per cent of our ‘happiness’ is pre-determined by our genetics, and c. 10 per cent by our circumstances and environment, managing oneself to get the most of the remaining 50 per cent available for us to influence isn’t always easy. Prof Laurie Santos from Harvard, and The Happiness Lab podcast, tells us we can however control a number of things, and we can work at these things.

We can support our happiness by being more present, by cultivating gratitude on a daily basis, by exercising daily, by spending time in nature, by having positive sleep habits, including minimising alcohol intake and technology use, by being with our emotions through accepting and breathing into them, using meditation and reflection as a support, and by nurturing our healthy social connections and relationships. There’s a lot that’s in our control really, isn’t there?

I know given the nature of our work, especially in community pharmacy, it can often feel overwhelming. That everyone wants a piece of us, and that we’re not getting that time we need to recoup in order to restore ourselves to the best we can be.

I hope that sharing some of my thoughts above will encourage some people to reflect on how they are doing, mentally, physically, emotionally and spiritually. Have a think about all that is in the bounds of our control, and maybe there are a couple of things you will change that will resource you on your journey. That cliché about happiness being a journey rather than a destination comes to mind.

Some people just have to work harder at it. ●

Ultan Molloy is a business and professional performance coach, pharmacist, facilitator, and development specialist. He works with other pharmacists, business owners, and third parties to develop business strategies. Ultan can be contacted on 086 169 3343.

The pharmacist as healer

Does being a healthcare professional mean being a healer, asks Niamh Cahill

The 1 of February traditionally heralded the start of spring, proclaiming brighter and warmer days ahead. On Erin’s Isle, the date also marked a day of celebration in honour of Saint Bridget, one of three of Ireland’s patron saints.

Renowned for her compassion towards animals and the poor, St Bridget is patron of many things, including poets and blacksmiths. Of most significance, perhaps, was her ability to perform miracles and heal the sick.

Referred to as a ‘goddess of healers’, she is said to have cured blindness and healed leprosy. And most of us will remember — if we were listening intently at school, that is — the fascinating tale of how she magically spread out her cloak, stretching it far across the fields, ensuring she would gain enough land from the King of Leinster to build a monastery.

Unlike St Bridget, pharmacists are not miracle-workers, at least not in any magical sense. But do pharmacists perhaps possess one of St Bridget’s most important traits? Are pharmacists healers?

The concept is no doubt one that rarely enters the mind ahead of another busy day dispensing medication and helping patients. Indeed, musing on it brings forth more questions. What is a healer?

A quick look at the dictionary reveals words such as ‘repair’ and ‘mend’. Definitions put forward state that healers alleviate stress

and anguish. On this basis, pharmacists, as healthcare professionals and clinicians, could easily be viewed as healers.

But the definitions seem to omit an important, perhaps overlooked facet of healing: The skill of listening, which all proficient healers, like St Bridget, must possess. One cannot completely and holistically treat a condition without first listening to a patient’s concerns.

The Greek physician Hippocrates many centuries ago espoused the importance of listening, as have many medical professors since.

The Hippocratic Oath asked doctors to avoid harming patients and to adopt a professional approach to helping and treating patients.

For centuries, apothecaries and medicinal experts, forerunners to pharmacists today, have adopted Hippocrates’ approach when treating patients.

The dictionary describes a pharmacist as being “a person who is professionally qualified to prepare and dispense medicinal drugs”. But as people are waking up to, you are so much more than that.

In more recent times, pharmacists have shifted from being merely dispensers of medications to healers, advisors, and holistic healthcare providers. The role of pharmacist has evolved and changed significantly and will continue to do so in the years ahead.

The demands on GPs and indeed the entire healthcare service in

recent decades have meant patients seeking advice and care have increasingly leant on the specialist knowledge of pharmacists.

Following recommendations by the Expert Taskforce to Support the Expansion of the Role of Pharmacy, community pharmacists can now prescribe for a restricted list of conditions, a list which will no doubt rise in the future.

More than ever before, pharmacists are being asked to listen to patients, which has, it can be argued, propelled the concept of pharmacist as healer to the fore.

Are more and more medication errors occurring all the time, or is the rise in harmful incidents due to better reporting?

Research has shown that medical errors can often be avoided by listening to the patient and making them a central part of the healthcare process.

Evidence has shown that if patients feel they are being listened to and that they are playing a role in the management of their condition, and are not merely passive participants in a healthcare providers' plans, but are more likely to adhere to medication regimens and feel

Are more and more medication errors occurring all the time, or is the rise in harmful incidents due to better reporting?

The role of healer in medicine and indeed pharmacy is often disregarded. But it comes sharply into focus when one considers how an incorrect medication or incorrect dose could have devastating consequences for patients.

The delivery of healthcare takes place in fraught and busy environments. But this does not mean that mistakes cannot be prevented.

Recent data released by the HSE via Freedom of Information legislation revealed that in 2023, nine patients suffered long-term disability/incapacity (including psychosocial) harm due to adverse medication incidents.

In the same year, a further 244 patients, according to the HSE National Incident Management System (NIMS) for recording safety incidents, suffered injuries that required medical treatment due to medication errors.

Furthermore, in 2022, 193 patients suffered injuries that required medical treatment due to medication errors.

satisfied with their care.

Pharmacists are a central component in ensuring patients receive the best treatment possible. It is worth stressing that by listening to patients, even without dispensing any medication, healing is possible. Through listening, pharmacists can act like a soothing balm, reducing the suffering and anxiety felt by a person.

How many times in our lives have we felt all the better for simply being listened to? ●

Niamh Cahill has a Masters in Journalism and a BSc in Communications: Film and Broadcasting from the Technological University Dublin (formerly Dublin Institute of Technology). She has been a journalist for more than 17 years and has spent much of this time writing about health. She is currently a freelance healthcare journalist.

Getting control of diabetes

Damien O’Brien MPSI looks at treatment considerations in different types of diabetes and the role of the pharmacist

Introduction

Diabetes is a metabolic disease characterised by elevated blood glucose levels due to insufficient insulin production, impaired insulin action, or a combination of both. Diabetes can lead to a wide range of health complications. It is classified into several types, with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) being the most prevalent. The pathogenesis of each type is different, with varying aetiology, presentation and management.

Diabetes places a major burden on the healthcare system, causing significant morbidity, mortality and reduced quality of life. It therefore requires a comprehensive management

plan, with both pharmacological and non-pharmacological interventions necessary to achieve optimal clinical outcomes. Pharmacists play a vital role in the management of diabetes, including optimising treatment plans, providing patient education, and monitoring for complications.1

Background on type 1 diabetes mellitus (T1DM)

T1DM is an autoimmune condition characterised by the destruction of pancreatic beta cells responsible for insulin production. It is commonly diagnosed in childhood or adolescence, though it can be diagnosed at any age. A combination of genetic predisposition and environmental

factors, including infections or toxins, may trigger autoimmunity.

Symptoms of T1DM include polyuria, polydipsia, polyphagia, fatigue, unexplained weight loss, and blurred vision. These symptoms can often develop rapidly and lead to diabetic ketoacidosis if not treated appropriately.1,2

Background on type 2 diabetes mellitus (T2DM)

T2DM is a chronic metabolic condition characterised by insulin resistance, where body cells become less responsive to insulin. This is initially countered by an increase in insulin production to maintain glucose homeostasis, but this compensatory mechanism declines over time, leading to T2DM. It typically occurs

in adults over 45 years of age, but is increasingly observed in younger populations due to rising obesity levels, physical inactivity, and energydense diets.

T2DM involves a complex interplay between genetics and lifestyle factors, including poor diet, obesity, and lack of physical activity. T2DM often has a gradual onset, with many patients remaining asymptomatic for years. Symptoms may be similar to those of T1DM and may also include recurrent infections and slow-healing wounds.1,3

Complications

There are several complications associated with diabetes.

Hypoglycaemia is defined as a plasma glucose concentration below 3.9mmol/L, with symptoms including fatigue, confusion, tremors, palpitations and seizures. Hypoglycaemia can result in diabetic coma and potential death. Hypoglycaemia is much more common in T1DM than T2DM. The most common causes of hypoglycaemia include incorrect medication administration, insufficient food intake, increased physical activity, and excessive alcohol intake. 1,2

Macrovascular complications involve large blood vessels in the body and are prevalent in diabetes. These complications are associated with poor glycaemic control, insulin resistance, and excess fatty acids. Coronary artery disease, peripheral vascular disease and cerebrovascular disease are complications of diabetes that cause significant morbidity and mortality. These macrovascular complications can lead to an increased risk of myocardial infarction, stroke, poor circulation, and amputation. 4

Microvascular complications involve the small blood vessels in the body and typically include retinopathy, nephropathy and neuropathy. These complications are generally due to poor glycaemic control. Diabetic retinopathy is damage to the retina

Physical activity is vital, as it has beneficial effects on insulin sensitivity and overall health, but it requires careful management to avoid glucose fluctuations

that can potentially lead to blindness. Diabetic nephropathy is the chronic loss of kidney function in patients with diabetes, which may progress to endstage renal disease. Diabetic neuropathy is a microvascular complication associated with nerve damage, causing pain, numbness, weakness, tingling, and urinary symptoms. 5

Diagnosis

The diagnosis of diabetes is typically based on a characteristic history, supported by elevated serum glucose levels. A diagnosis of diabetes can be made if any of the following criteria are met:

 Fasting plasma glucose (FPG) level ≥7.0mmol/L after an eight-hour fast.

 Oral glucose tolerance test (OGTT): A plasma glucose level ≥11.1mmol/L two hours after a 75g glucose load.

 Glycated haemoglobin (HbA1c) level ≥6.5%: Glycated haemoglobin is a form of haemoglobin that is linked to a sugar molecule and is used to determine the three-month average plasma glucose level.

 Random plasma glucose level ≥11.1mmol/L along with symptoms of hyperglycaemia (polyuria, polydipsia, polyphagia, weight loss).1

Non-pharmacological treatment

The management of diabetes necessitates a multi-faceted approach for effective control. Nonpharmacological approaches are crucial in the management of diabetes. Optimal management of T1DM requires patient education on diet and lifestyle. Patients should understand the interaction between diet, insulin, physical activity and daily routine, with nutritional

education on carbohydrate estimation being important in managing this condition. Consultation with a dietitian can help diabetic patients learn carbohydrate estimation to determine appropriate mealtime insulin dosing.

Physical activity is vital, as it has beneficial effects on insulin sensitivity and overall health, but it requires careful management to avoid glucose fluctuations. Smoking cessation should be promoted to reduce cardiovascular risks, while moderating alcohol intake is important as it can affect blood glucose levels. 2

The cornerstone of treatment of T2DM is diet and physical activity. Reducing intake of refined carbohydrates and saturated fats, while increasing the intake of fibre and monounsaturated fats, is crucial. A minimum of 90-to-150 minutes of aerobic exercise per week should be encouraged. In obese patients, weight loss should be promoted to improve insulin sensitivity. Similarly to T1DM, smoking cessation and reducing alcohol intake should be encouraged. 3

Pharmacological treatment in T1DM

The goal of pharmacological management of T1DM is the replacement of insulin. This is achieved through the administration of multiple daily insulin injections (basal-bolus), or continuous subcutaneous insulin infusion using an insulin pump.

Basal-bolus insulin treatment involves administering a long-acting basal insulin once or twice daily, and a prandial short- or rapid-acting insulin administered before meals. Long-acting insulin is often administered once daily and used for the basal dose to maintain baseline glucose levels, with

examples including glargine and detemir. Intermediate-acting insulin is typically injected twice daily and includes neutral protamine Hagedorn (NPH) or neutral protamine lispro. Rapid-acting insulin is generally administered 10-to-15 minutes before meals, with examples including aspart, lispro and glulisine.

Basal-bolus regimens typically include a daily long-acting insulin, as well as a rapid-acting insulin before meals for hyperglycaemia correction. The regimen should be titrated to achieve a blood glucose range that minimises the risk of hypoglycaemia and hyperglycaemia. Continuous subcutaneous insulin infusion administers a continuous infusion of rapid-acting insulin to meet basal requirements, with mealtime boluses administered for prandial coverage. 2

Pharmacological treatment in T2DM

Patients with T2DM are more likely to develop various complications; therefore, the objective of treatment is to achieve optimal glycaemic control to reduce the risk of these complications. Pharmacological management is indicated if adequate glycaemic control cannot be achieved through diet and exercise.3

Metformin is considered first-line treatment for T2DM. It is recommended initially as monotherapy if the HbA1c is 9% or lower at diagnosis, while it may be recommended as part of combination therapy if the HbA1c level is greater than 9%. Metformin is a biguanide that lowers blood glucose levels by decreasing glucose production in the liver, reducing intestinal absorption, and improving insulin sensitivity. Therefore, metformin effectively lowers both basal and postprandial blood glucose levels. Metformin is considered weightneutral, with the potential for modest weight loss. It is unlikely to cause hypoglycaemia and may have cardioprotective effects. Common adverse effects of metformin include nausea, vomiting, diarrhoea, and abdominal pain. Taking metformin

with food and gradually titrating the dose upwards can help limit these adverse effects. 3,6

Sulfonylureas stimulate pancreatic beta cells to increase insulin secretion. They can be used as monotherapy or in combination with other antidiabetic drugs, except the meglitinides, as they have a similar mechanism of action.

Sulfonylureas can lower HbA1c by 1% to 1.25%. Treatment should be initiated at a low dose, with a gradual increase based on glycaemic control.

Gliclazide is available as an immediate-release tablet (taken twice daily 30 minutes before food), or a modified-release tablet (taken once daily after food). Patients may need to hold or reduce their dose and ensure monitoring of blood glucose levels if fasting. Sulfonylureas are often used as an add-on to metformin, as they have different mechanisms of action and improve glycaemic control. Furthermore, this combination may have a neutral impact on body weight, as sulfonylureas may cause weight gain. Weight gain is a common adverse effect, and sulfonylureas should not be offered to obese patients.

Hypoglycaemia is also a common adverse effect and may be severe, particularly after missing meals, exercise or with high doses. Other adverse effects may include nausea, vomiting, diarrhoea and dizziness. 3,7

Dipeptidyl peptidase-4 (DPP-4) inhibitors work by acting on incretin hormones, mainly GLP-1 (glucagon-like peptide-1) and GIP (gastric inhibitory peptide), which maintain glucose homeostasis by stimulating insulin secretion and decreasing glucagon secretion. Linagliptin, saxagliptin and sitagliptin are examples of DPP-4 inhibitors. They are all administered orally once daily after food. They can be used as monotherapy or as an add-on treatment option with other antidiabetic medications. They also have the benefit of possessing antihypertensive, anti-inflammatory and immunomodulatory effects.

They are generally a well-tolerated class of medication, with weightneutral effects and a low incidence of hypoglycaemia. However, the risk of hypoglycaemia increases when used in conjunction with sulfonylureas. Upper respiratory tract infections, gastrointestinal issues, headaches, and urinary tract infections are the most common adverse effects. 3,8

Sodium-glucose co-transporter-2 (SGLT-2) inhibitors work by blocking the reabsorption of glucose in the kidneys, thereby lowering plasma glucose levels. Dapagliflozin, empagliflozin, and canagliflozin are all examples. They are administered orally, with canagliflozin taken before breakfast and the others taken with or without food.

In addition to their glucose-lowering effects, SGLT-2 inhibitors may also be used for the management of renal or cardiovascular disease. They may promote some weight loss, and the risk of hypoglycaemia increases in elderly patients. These medications may be used as add-on therapy, particularly in patients with comorbidities such as atherosclerosis, heart failure, or chronic kidney disease. The most common adverse effects include nausea, constipation, urinary tract infections, and increased urination. 3.9

Thiazolidinediones act on intracellular metabolic pathways to improve insulin action and increase insulin sensitivity. Pioglitazone is a thiazolidinedione used as monotherapy or in combination with other antidiabetic medications. It is administered orally once daily, with or without food.

Thiazolidinediones may be useful, as they typically do not cause hypoglycaemia when used as monotherapy, and they are not contraindicated in patients with renal disease. However, due to their adverse effect profile, they are typically not used as first-line treatment unless other medications are contraindicated. The adverse effects of thiazolidinediones include weight gain, bone fractures, water retention, congestive heart

Real-time glucose readings sent right to your patients’ smartphones4,5

Significant clinical outcomes for T1D8 and T2D2,9,10 Optional glucose alarms6 every minute CGM=continuous

Outstanding 14-day accuracy, even in the low glucose range7

accuracy, even in the low glucose range Significant clinical outcomes for T1D

Optional glucose alarms every minute CGM=continuous glucose monitoring; T1D=type 1 diabetes mellitus; T2D=type 2 diabetes mellitus. *FreeStyle Libre 2 flash glucose monitoring is continuous glucose monitoring system. 1. Campbell, F. Pediatr Diabetes (2018): https://doi.org/10.1111/pedi.12735. 2. Haak, T. Diabetes Therapy (2017): https://doi.org/10.1007/s13300-016-0223-6. 3. Data on file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre portfolio compared to the number of users for other leading personal use sensor-based glucose monitoring systems. 4. The FreeStyle LibreLink app is only compatible with certain mobile devices and operating systems. Please check the website for more information about device compatibility before using the app. Use of FreeStyle LibreLink may require registration with LibreView. 5. Glucose readings are automatically displayed in the app only when the smartphone and sensor are connected and in range. 6. Patients choose which device they

2. Haak, T. Diabetes Therapy (2017): https://doi.org/10.1007/s13300-016-0223-6. 3. Data on file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre portfolio compared to the number of users for other leading personal use sensor-based glucose monitoring systems. 4. The FreeStyle LibreLink app is only compatible with certain mobile devices and operating systems. Please check the website for more information about device compatibility before using the app. Use of FreeStyle LibreLink may require registration with LibreView. 5. Glucose readings are automatically displayed in the app only when the smartphone and sensor are connected and in range. 6. Patients choose which device they want to receive alarms: FreeStyle Libre 2 reader or FreeStyle LibreLink app. They must start their FreeStyle Libre 2 sensor with that selected device. Once the patient scans their FreeStyle Libre 2 sensor with that device, they can receive alarms only on that device. Alarm notifications will only be received when alarms are turned on and the sensor is within 6 metres (20 ft) unobstructed of the reading device. 7. Alva

FreeStyle Libre 2 reader or FreeStyle LibreLink app. They must start their FreeStyle Libre 2 sensor with that selected device. Once the patient scans their FreeStyle Libre 2 sensor with that device, they can receive alarms only on that device. Alarm notifications will only be received when alarms are turned on

failure, hepatotoxicity, and an increased risk of bladder cancer.10

Meglitinides bind to receptors on beta cells in the pancreas, stimulating the release of endogenous insulin. Repaglinide an example of a meglitinide used in the treatment of T2DM. Similar to other antidiabetic drugs, it can be used as monotherapy or in combination with other agents, with the exception of sulfonylureas due to their similar mechanism of action. They are administered orally before meals two or three times daily, with doses omitted if meals are skipped. Common adverse effects include hypoglycaemia, weight gain, upper respiratory tract infections, diarrhoea, and joint pain.11

Glucagon-like peptide-1 (GLP-1) agonists work by activating the GLP-1 receptor, which delays gastric emptying, inhibits glucagon release, and stimulates the production of insulin. Dulaglutide, semaglutide, exenatide and liraglutide are examples of GLP-1 agonists used to treat T2DM. GLP-1 agonists can be used as monotherapy or in combination with other antidiabetic medications. They have a relatively low risk of hypoglycaemia. Additionally, they may lower the risk

References

1. Sapra A and Bhandari P (2023). Diabetes. [online] PubMed. Available at: https://www. ncbi.nlm.nih.gov/books/NBK551501/

2. Lucier J and Weinstock RS (2024). Diabetes mellitus type 1. [online] Nih.gov. Available at: https://www.ncbi.nlm.nih.gov/books/ NBK507713/.

3. Goyal R, Jialal I, and Singhal M (2023). Type 2 diabetes. [online] National Centre for Biotechnology Information. Available at: https://www.ncbi.nlm.nih.gov/books/ NBK513253/.

4. Viigimaa M, Sachinidis A, Toumpourleka M, Koutsampasopoulos K, Alliksoo S, and Titma T (2019). Macrovascular complications of type 2 diabetes mellitus. Current Vascular Pharma-

of cardiovascular events, prevent the progression of chronic kidney disease and promote weight loss. Therefore, they may be particularly beneficial for patients with these comorbidities.

GLP-1 agonists are typically administered via subcutaneous injection due to their poor oral bioavailability. Liraglutide is administered daily, while dulaglutide and semaglutide are administered once weekly. Exenatide can be administered either twice daily or once weekly, depending on the formulation. Nausea, vomiting and diarrhoea are the most common adverse effects of GLP-1 agonists. Other possible adverse effects include tachycardia, dizziness, infection, headache, injection site reactions, and acute kidney injury.12

Insulin therapy may be used in advanced stages of T2DM when noninsulin agents fail to achieve adequate glycaemic control. Insulin may also be useful in short-term cases to lower blood glucose levels after diagnosis or when a patient is ill. Insulin effectively reduces hyperglycaemia and the longterm complications associated with it. However, hypoglycaemia is more common with insulin therapy, although

it is less frequently associated with other adverse effects, such as gastrointestinal issues. 3

Role of the pharmacist

Pharmacists play a crucial role in the management of diabetes through medication management, patient education, and patient monitoring. Pharmacists counsel patients on important aspects of medication management, including injection techniques, the importance of adherence, hypoglycaemia management, and strategies to minimise adverse effects. Additionally, pharmacists educate patients on lifestyle changes, such as dietary modifications, physical exercise, alcohol moderation and smoking cessation, which can help prevent diabetes-related complications. Pharmacists also assist in monitoring patients and screening for complications, which may improve clinical outcomes. Finally, they collaborate with other healthcare professionals to provide a patient-centered approach to diabetes management. ●

cology, 18(2). doi:https://doi.org/10.2174/1570 161117666190405165151.

5. Vithian K and Hurel S (2010). Microvascular complications: pathophysiology and management. Clinical Medicine, [online] 10(5), pp.505–509. doi:https://doi.org/10.7861/clinmedicine.10-5-505.

6. Corcoran C and Jacobs TF (2023). Metformin. [online] Nih.gov. Available at: https://www.ncbi.nlm.nih.gov/books/ NBK518983/.

7. Costello, R.A. and Shivkumar, A. (2023). Sulfonylureas. [online] PubMed. Available at: https:// www.ncbi.nlm.nih.gov/books/NBK513225/.

8. Kasina, S.V.S.K. and Baradhi, K.M. (2023). Dipeptidyl Peptidase IV (DPP IV) Inhibitors. [online] PubMed. Available at: https://www.ncbi.nlm.nih.

gov/books/NBK542331/.

9. Padda IS, Mahtani AU, and Parmar M (2023). Sodium-Glucose Transport Protein 2 (SGLT2) Inhibitors. [online] PubMed. Available at: https://www.ncbi.nlm.nih.gov/books/ NBK576405/.

10. Eggleton JS and Jialal, I (2020). Thiazolidinediones. [online] PubMed. Available at: https://www.ncbi.nlm.nih.gov/books/ NBK551656/.

11. Milner Z and Akhondi H (2023). Repaglinide. [online] PubMed. Available at: https://www.ncbi. nlm.nih.gov/books/NBK559305/.

12. Collins L and Costello, RA (2024). Glucagon-like peptide-1 receptor agonists. [online] PubMed. Available at: https://www.ncbi.nlm.nih. gov/books/NBK551568/.

A sporting chance for recovery

With all the health benefits associated with sport, chronic or acute injuries can be a downside, writes Damien O’Brien

MPSI

Introduction

Sport has many benefits associated with it, including improving cardiovascular function, reducing the risk of type 2 diabetes, strengthening bones, and improving respiratory function. Sport also contributes to personal development and has psychosocial benefits, including reducing stress and improving mental health. However, there are negative effects of sport, and this article will focus on sports injuries.

Sports injuries refers to damage to body tissue that occurs due to sport or exercise. Sports injuries can be broadly classified into two categories — acute and chronic injuries. Acute injuries typically happen suddenly and include ligament sprains, joint dislocations, contusions and bone fractures. Chronic injuries develop gradually over time and generally result from overuse of a part of the body. Examples of chronic injuries include stress fractures and tendinopathies.

Pharmacists are accessible healthcare professionals and have the clinical knowledge to be the first port of call for a range of sports-related injuries. Pharmacists play an important role in identifying common injuries, counselling

patients on pharmacological and nonpharmacological treatment options, and referring the patient if necessary. 1,2,3

Sports injuries can occur at any time to an individual, but several factors can increase the risk of injury. Overtraining, involving either training too often or for too long, is one of the most common reasons for injury. Other factors that may increase the risk of injury include

not using the correct exercise technique, changing training intensity too quickly, or not wearing proper equipment.

Preventative measures can be implemented to reduce the risk of sports injuries. Dynamic stretching, using protective equipment, active recovery, and following appropriate training regimens that are activity-specific are all methods to effectively reduce risk of sports injuries.2,3

Classification

There is a wide range of sports injuries, each with different symptoms and complications. Some common musculoskeletal injuries are outlined below:

 Fracture - A break in a bone that can occur from a one-time injury, known as an acute fracture, or from repetitive impact, known as a stress fracture. Stress fractures usually occur in weightbearing bones in the legs.

 Dislocation – Occurs when the two bones that come together to form a joint become separated. It is common in the shoulders, elbows, fingers and kneecaps.

 Tendonitis – Inflammation of the tissue that attaches muscle to bone. It often affects the ankle, knee, hip, elbow, or shoulder and is typically due to repetitive actions.

 Sprain – A stretch or tear of the ligaments, which are connective tissues that join bone-to-bone. Sprains can range from a minimally-stretched ligament, to a complete tear. They are most common in the ankles, knees, wrists and fingers.

 Strain – A pull or tear of a muscle or tendon. They can range from a minor strain to a complete tear of the muscle or tendon.2

Diagnosis

Accurate diagnosis of sports injuries is critical for effective management. Diagnosis can be complex and may require various approaches. A detailed patient history is important to establish the mechanism of injury and any symptoms present. A physical examination of the injury helps to observe bruising and inflammation, as well as to assess functional limitations. Imaging techniques, including magnetic resonance imaging (MRI) scans, x-rays, ultrasound and computed tomography (CT) scans are used to evaluate soft tissue and bone injuries. 2

Treatment

The treatment of sports injuries may depend on the severity of the injury, location, and presence of inflammation. Some injuries may heal within days, while others may take several weeks or months

to fully heal. The objectives of treatment are the full recovery of the injury and the prevention of future injuries. There are several pharmacological and nonpharmacological treatment options for sports injuries.4

Pharmacological treatment

Paracetamol

Paracetamol is an analgesic used to treat mild-to-moderate pain and can be effective in managing sports injuries. It can be used as monotherapy or in combination with other pharmacological or nonpharmacological treatment options. While it does not have the anti-inflammatory properties that other analgesics may have, it is useful for treating mild-to-moderate nociceptive pain.

The objectives of treatment are the full recovery of the injury and the prevention of future injuries

Paracetamol is safe when used correctly, with a favourable adverse effect profile. The maximum recommended dose of paracetamol for adults (aged 12 years and older) is 1g every 4-6 hours, up to 4g per day. In children, a weight-based dosing approach is more appropriate, with 15mg/kg per dose recommended.4

Opioids

Opioids are not recommended as firstline treatment for sports injuries. They should be reserved for cases where the pain is uncontrolled, such as post-surgery or a major fracture. They may also be useful if other treatment options are contraindicated or not tolerated. Several adverse effects are associated with opioids, limiting their use as analgesics for sports injuries. Some of these adverse effects include sedation, constipation, nausea, vomiting,

bradycardia, respiratory depression, tolerance, and physical dependence. Opioids should only be used for sports injuries if the expected benefit for pain relief and function outweighs the risk of adverse effects. They should be used at the lowest effective dose and for the shortest duration possible.4

Non-steroidal antiinflammatory drugs (NSAIDs)

Non-steroidal anti-inflammatory drugs (NSAIDs) are effective in treating sports injuries by reducing pain, decreasing inflammation, and improving mobility. NSAIDs work by inhibiting cyclooxygenase (COX) enzymes, both COX-1 and COX-2. This inhibits the synthesis of prostaglandins, which are mediators involved in inflammation and pain. NSAIDs are effective in reducing pain and inflammation in sports injuries when used as monotherapy or in combination with another analgesic, such as paracetamol. There are several NSAIDs used to treat sports injuries, and the choice may depend on a variety of factors, including comorbidities, bleeding risk, cost, availability, dosing schedule, and adverse effect profile. Aspirin and ibuprofen are available over the counter, while celecoxib, etoricoxib, diclofenac, meloxicam, naproxen, dexketoprofen and mefenamic acid are examples of NSAIDs available on prescription.

The adverse effects of NSAIDs include gastrointestinal discomfort, gastrointestinal haemorrhage, hepatotoxicity, reduced kidney function, hypertension, and thromboembolic events. Higher-risk patients and patients on long-term NSAID therapy may require monitoring, including a complete blood count, renal function, and hepatic function. 4,5

NSAIDs play an important role in ligament sprains by reducing pain and inflammation, while increasing the chances of the patient regaining physical function. In muscle injuries, NSAIDs may provide pain relief and allow the patient to resume normal activity. They may not have a significant impact on

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*Wade AG, Crawford GM, Young D, et al. Comparison of diclofenac gel, ibuprofen gel, and ibuprofen gel with levomenthol for the topical treatment of pain associated with musculoskeletal injuries. J Int. Med Res. 2019;47(9):4454-4468.

DICLOMEL MAX STRENGTH 2% w/w GEL. 1 g of gel contains diclofenac as 23.2 mg diclofenac diethylamine corresponding to 20 mg of diclofenac sodium. Presentation: Tube containing white, homogeneous gel. Indications: For short-term local symptomatic treatment of mild to moderate pain in acute strains, sprains or contusions following blunt trauma. Dosage: Adults and adolescents aged 14 years and over: Diclomel Max Strength is used 2 times a day (preferably morning and evening). Depending on the size of the affected site to be treated, cherry to walnut size quantity is required, corresponding to 1-4 g of gel corresponding to 20-80 mg diclofenac sodium. This is sufficient to treat an area of 400-800 cm2. The maximum daily dose is 8 g of gel corresponding to 160 mg diclofenac sodium. Method of administration: For cutaneous use. Contraindications: Hypersensitivity to the active substance or any of the excipients, patients with a history of hypersensitivity reactions, such as asthma, bronchospasm, urticaria, acute rhinitis or angioedema in response to acetylsalicylic acid or NSAIDs, on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes, in the last trimester of pregnancy, in children and adolescents under 14 years of age. Warnings and precautions: The possibility of systemic undesirable effects from application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and over a prolonged period. The gel should therefore be used with caution by patients with reduced renal function, reduced heart function or reduced liver function as well as patients with active peptic ulcers in the stomach or duodenum. Diclomel Max Strength must only be applied to intact, not diseased or injured skin. Eyes and oral mucous membranes must not come into contact with the gel and it must not be taken orally. Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing. If symptoms worsen or do not improve after 3-5 days, a doctor should be consulted. Patients suffering from asthma, hay fever, swelling of nasal mucous membranes (nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory infections (particularly hay fever-like symptoms), and patients with hypersensitivity to painkillers and anti-rheumatic medicinal products of all kinds are rather at risk to asthma attacks, to local skin or mucous membrane swelling (Quincke oedema) or to urticaria than other patients when treated with Diclomel Max Strength. In these patients, Diclomel Max Strength may only be used under certain precautions (emergency preparedness) and direct medical supervision. The same applies for patients who are also allergic to other substances, e.g. with skin reactions, itching or urticaria. If a skin rash occurs with Diclomel Max Strength the treatment should be stopped. Direct sunlight or artificial sun should be avoided during treatment and two weeks after treatment to avoid the risk of photosensitivity. Preventive measures should be taken so that children do not contact the skin areas to which the gel has been applied. Diclomel Max Strength contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. Diclomel Max Strength contains fragrance with eugenol and citral which may cause allergic reactions. Interactions: Since the systemic absorption of diclofenac is very low with topical application, such interactions are very unlikely in use as intended. Fertility, pregnancy and lactation: During the first and second trimester of pregnancy, diclofenac should not be used unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Diclofenac is contraindicated during the third trimester of pregnancy. Diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Diclomel Max Strength no effects on the breast-fed child are anticipated. Because of a lack of controlled studies in breast-feeding women, the medicinal product should only be used during breast-feeding under advice from a healthcare professional. Under this circumstance, Diclomel Max Strength should not be applied on the breasts of breast-feeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time. Driving and operation of machinery: The topical use of diclofenac has no or negligible influence on the ability to drive and use machines. Undesirable effects: Dermatitis (including contact dermatitis), skin rash, erythema, eczema, pruritus. Refer to Summary of Product Characteristics for other adverse effects. Adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Pack size: 50 and 100 mg tubes. A copy of the Summary of Product Characteristics is available upon request or go to www.clonmelhealthcare.ie Marketing authorisation holder: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, Ireland. Marketing authorisation number: PA0126/372/001. Medicinal product not subject to medical prescription. Date last revised: March 2024. Date prepared: June 2024. 2024/ADV/DIC/122H.

tendinopathies, where inflammation is not the main issue, but they may be useful in providing analgesia.

Some evidence suggests that chronic NSAID use may impair the bone-healing process, but short-term use for pain and inflammation is thought to have little impact on overall healing.3

Topical NSAIDs

Topical NSAIDs can be used in the treatment of sports injuries. They involve applying the medication directly onto unbroken skin or via a transdermal patch and are effective in musculoskeletal strains and sprains. Diclofenac and ibuprofen are available over the counter as topical preparations, while etofenamate and ketoprofen are available on prescription. Topical application may be particularly useful if a patient cannot tolerate oral NSAIDs. Systemic absorption is estimated at 1-7% across topical NSAIDs, which leads to a much safer systemic adverse effect profile. Systemic adverse effects are rare, while local adverse effects include dermatitis and pruritis. 5

Non-pharmacological treatment

Pharmacists can also recommend nondrug therapies, either as monotherapy or in combination with pharmacological treatment, for treating sports injuries. The P-R-I-C-E method is an approach for acute soft tissue injuries to reduce inflammation and pain:

 Protect - Support the injured body area to prevent further injury.

 Rest - Limit activities that involve using the injured body part in the initial phase of the injury.

 Ice - Apply ice (wrapped in a towel) for approximately 20 minutes to the injured area, up to eight times per day.

 Compression – Apply pressure to the injured area to reduce inflammation.

 Elevation - Keep the injured body part elevated above the heart level, if possible, to reduce inflammation.2

Immobilising the injured area can help

limit movement and allow blood to flow to the injury site. Immobilisation may be required for a limited time to help reduce pain, decrease inflammation and improve the healing process. Slings, splints, braces and casts are often used to immobilise the body part while also offering protection and support.

Surgery may be necessary in certain circumstances to realign fractured bones or repair torn connective tissue. After the healing process, a rehabilitation programme designed by a physiotherapist may help rebuild strength, improve function, and ease any residual pain. 4

Concussion management

A concussion is a type of mild traumatic brain injury (mTBI) that is common in contact sports. Concussion is defined as a clinical syndrome of biomechanically induced alteration of brain function, typically affecting memory and orientation, and may involve loss of consciousness. Concussion is typically caused by a bump to the head or a hit to the body that causes the head to move back and forth rapidly. In most cases, concussion symptoms resolve within a couple of weeks. Common symptoms include dizziness, headache, nausea, vomiting, confusion and amnesia. Other symptoms in the following hours and days may include lethargy, mood disturbance, sleep disturbance, and sensitivity to light or noise. Warning symptoms that warrant further medical attention include unsteadiness, confusion, fever, inability to wake, numbness, weakness, vision problems, and seizures. Repeated concussions are linked with

References

1. Centres for Disease Control and Prevention (2024). Benefits of Physical Activity. [online] Physical Activity Basics.

2. NIAMS (2018). NIAMS Health Information on Sports Injuries. [online] National Institute of Arthritis and Musculoskeletal and Skin Diseases.

an increased risk of chronic traumatic encephalopathy, Parkinson's disease, and depression. 6,7

The acute management of concussion involves observation in the home or an acute setting for at least 24 hours. Physical and cognitive rest — avoiding screens, reading, and strenuous activities — is recommended. Patients should have a gradual return to regular activities under medical guidance.

Paracetamol may be used to relieve pain associated with concussion. It is preferred over NSAIDs due to the risk of intracranial haemorrhage with NSAID use. Individuals should also be educated on proper technique and protective equipment in sports as a preventive measure.6,7

Role of the pharmacist

Pharmacists are ideally placed to contribute to the prevention, management, and recovery from sports injuries. Pharmacists are among the most accessible healthcare providers and are often the first point of access for patients with a sports injury. Pharmacists may provide first aid in the pharmacy to patients who have cuts, abrasions, bruises or other injuries. They also counsel patients on over-the-counter and prescription medication, advising on appropriate medication use, potential adverse effects, and interactions. Pharmacists can also refer patients to the appropriate channels if necessary. In conclusion, they play a crucial role in alleviating symptoms, ensuring medication safety, and promoting recovery from sports injuries. ●

3. Thomas T, Mottram D, and Waldock C (n.d.). Advising patients on prevention and management of sporting injuries in the pharmacy. [online] The Pharmaceutical Journal

4. Queremel Milani DA, and Davis DD (2023). Pain management medications. [online] PubMed.

5. Amaechi O, Human MM, and Featherstone K (2021). Pharmacologic Therapy for Acute Pain. American Family Physician, [online] 104(1), pp.63–72.

6. Ferry B, and DeCastro A (2023). Concussion. [online] National Library of Medicine

7. HSE.ie. (n.d.). Head injury and concussion. [online].

Hot-footing it to the pharmacy

The pharmacy has become the first line in the treatment of common foot problems

Over the years, the community pharmacy has become the go-to option for patients seeking advice and treatment for their foot problems. The community pharmacy has become the best-placed and most cost-effective option for foot health in primary care, and the article below focuses on two of the most common foot problems: Fungal nail infections, and athlete’s foot ( Tinea pedis ).

Athlete’s foot

Tinea pedis belongs to a family of ringworms that invade different areas of the skin, in this case, the feet. As always, prevention is better than cure, so patients can be advised on some steps they can take to avoid athlete’s foot and to prevent it spreading to others. Feet should be washed daily in warm, soapy water and dried thoroughly, especially between the toes. If a patient is prone to athlete’s foot, they should be recommended a medicated powder. Socks should be changed once a day and patients should alternate the shoes they wear and feet should be protected in public places, with the added benefit of preventing the spread of the infection.

Patients with diabetes require special attention and should be advised to seek medical attention immediately if the foot is hot, red and painful, as this may indicate a more serious infection. Patients with a weakened immune system can also be susceptible to more serious infections, and all patients should also be advised to see their GP if they do not respond to treatment.

Early treatment is key to dealing with athlete’s foot, and it is unlikely that the condition will resolve on its own. The HSE advises people with athlete’s foot to consult their pharmacist as a first-

line option for advice and treatment. If standard treatments do not work, patients need to be referred to their GP, as they may need a prescriptionstrength cream or ointment to resolve a stubborn infection. More serious infections may require a combination of topical and oral treatments, which should be combined with the self-care measures outlined above.

When trying to establish if the infection is indeed athlete’s foot, it is often useful to ask if the patient regularly visits swimming pools or gyms, or if any other family member has the same symptoms.

Nail infections

Fungal nail infections sometimes arise due to athlete’s foot. To avoid this, patients should be advised to keep the feet clean and dry and to change their socks every day. Old shoes should be discarded and sandals should be worn at the pool or in the gym. Nail-clippers or scissors should not be shared with other people, and it is also best to use personal towels and avoid footwear that makes the feet hot and sweaty.

If athlete’s foot is not treated quickly

and effectively, it can result in a fungal nail infection. This usually affects the toenails, but can also affect the fingernails. This type of infection can make the nails brittle and painful, with thickening, and the nails can turn yellow.

The infection sometimes starts at the edge of the nail and spreads to the middle of the nail and when it becomes yellow, the nail can often be lifted off the toe. Nails with a fungal infection can also crack and fragment and the tissue around the nail becomes swollen and painful.

Treatment

The HSE recommends that people consult their pharmacist for advice and treatment in the form of antifungal creams, powders or sprays. These can include antifungal nail medications or nail-softening cream, and sometimes oral antifungal medication is required to deal with a persistent infection. Newer treatments have the added benefit of a once-off application, although these products are restricted to patients aged over 18 years.

Even with an effective antifungal treatment, it can take one-to-two weeks for any improvement to be seen with a fungal infection. Fungal nail infections can take longer to respond, sometimes 12 weeks or more, while an antifungal gel, cream or spray usually start to work within seven days. Oral prescription antifungals can take from two weeks to several months to show benefits. Patients taking the oral medication should be advised not to give blood for at least seven days after finishing their course.

If patients with diabetes have a fungal nail infection, they should be referred to their GP for further investigations. A foot injury can also make a fungal infection more likely. ●

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Heart of the matter

Cardiovascular disease is the second-leading cause of death in Ireland, but prevention and early intervention can save many lives, writes Damien O’Brien MPSI

Introduction

Heart health is fundamental to the overall wellbeing of an individual due to the heart’s crucial role in sustaining life through the circulation of oxygenated blood. The heart is a muscular organ located slightly to the left of the centre of the chest. It pumps blood through the blood vessels to all parts of the body, delivering oxygen and nutrients while carrying away waste products. The cardiovascular system is made up of the heart and blood vessels.

Cardiovascular disease is a significant public health challenge in Ireland. It is the second-leading cause of death in Ireland after cancer, causing approximately 9,000 deaths annually. Cardiovascular disease is also one of the leading causes of disability in Ireland, and many of these conditions may be preventable through health measures and early interventions.

Cardiovascular health involves the efficient functioning of the heart, blood vessels and circulatory system. Pharmacists are accessible healthcare professionals and are ideally positioned to support heart health through patient education, medication management, and promoting lifestyle modifications. This article outlines the pharmacist’s role in promoting heart health, the background of cardiovascular health, strategies for lifestyle modification and risk reduction, and pharmacological treatments.1

There is a wide range of conditions that may arise within the cardiovascular system, and these are categorised into the following four subtypes:

 Coronary artery disease (CAD) –Results from decreased myocardial perfusion, leading to angina, myocardial

infarction (MI), or heart failure.

 Cerebrovascular disease (CVD) –A group of conditions that affect blood flow to the brain, including stroke and transient ischaemic attack (TIA).

 Peripheral artery disease (PAD) –Occurs when blood flow is impaired to parts of the body other than the brain and heart.

 Aortic disease – A group of disorders that affect the aorta. The aorta is the largest blood vessel in the body and carries blood from the heart to the rest

of the body. One of the most common aortic diseases is an aortic aneurysm. 2

Cardiovascular risk factors

Several risk factors contribute to poor heart health. Risk factors are either non-modifiable, meaning they can't be changed, or modifiable, meaning that an individual can take steps to change them. Non-modifiable risk factors for cardiovascular disease include age, gender and family history. Age increases the risk of developing heart disease, with

approximately 80 per cent of patients who die from cardiovascular disease being 65 or older.

Family history is also a significant risk factor for cardiovascular disease. Individuals with a family history of premature cardiac disease before the age of 50 have an increased cardiovascular mortality risk. Men are also at an increased risk of heart disease, but it is a significant issue for both males and females. Although non-modifiable risk factors cannot be changed, it is still prudent to be aware of them.2,3

Modifiable risk factors also play a significant role in cardiovascular disease. These include hypertension, high cholesterol levels, diabetes, smoking, obesity, diet, and a sedentary lifestyle. Optimal pharmacological interventions and lifestyle modifications can help reduce these modifiable risk factors, thereby lowering morbidity and mortality.1

Lifestyle modifications for heart health

Lifestyle modifications are vital in the prevention and management of cardiovascular disease. Lifestyle factors profoundly affect the likelihood of developing cardiovascular disease. Evidence shows that regular physical activity, a healthy diet, maintaining a healthy weight, avoiding smoking, and moderating alcohol intake significantly reduce the risk of heart disease. The strength of the evidence supporting these daily health-promoting activities is reflected in their inclusion in evidencebased guidelines for the prevention and treatment of cardiovascular diseases. 4

A sedentary lifestyle is associated with an increase in cardiovascular disease incidence and mortality. The World Health Organisation (WHO) recommends that all adults from 18-to64 engage in a minimum of 150 minutes of moderate-intensity aerobic exercise per week. This can be achieved through activities such as running, walking, swimming or cycling. However, it is estimated that less than half of Irish adults achieve this objective.

Even a small increase in physical activity is thought to greatly reduce the risk of cardiovascular disease. Furthermore, physical activity can improve lipid profiles, reduce blood pressure, and aid in weight management.1,4

A poor diet is one of the main risk factors for the development of cardiovascular disease. Evidence suggests that a diet rich in fruits and vegetables is associated with a lower risk of cardiovascular disease. Furthermore, a diet containing oily fish, seafood, whole grains, fibre, legumes and nuts is associated with a lower risk of heart disease. Patients should be encouraged to follow a diet lower in processed meats,

A sedentary lifestyle is associated with an increase in cardiovascular disease incidence and mortality

refined grains, cholesterol, sodium, saturated fats and trans fats. A caloric balance should be maintained, with an emphasis on portion control. Guidelines also recommend that adults who consume alcohol do so in moderation.1,4

Maintaining a healthy weight is important to reduce the risk of heart disease and improve heart health. Both being overweight and obesity are significant risk factors for cardiovascular disease.

Obesity is associated with other risk factors such as diabetes, dyslipidaemia and hypertension, but it is also an independent risk factor for cardiovascular disease. Ireland has one of the highest obesity levels in Europe, with the number of people meeting the criteria for overweight and obesity more than doubling in the last 20 years. Lifestyle changes can produce significant weight loss and have important health benefits, with portion

control, healthy eating, and regular exercise being vital for this.1,4

Smoking is a major risk factor for cardiovascular disease, contributing to stroke and heart disease. Secondhand smoke also increases the risk of heart disease. Patient education about the risks of smoking is important for both children and adults. Smoking cessation is vital for patients who smoke, with pharmacological options including nicotine replacement therapy, varenicline and bupropion playing an important role in reducing cravings and withdrawal symptoms.

Behavioural strategies, including cognitive behavioural therapy, can also be effective in achieving and maintaining cessation. Significant reductions in cardiovascular risk can be observed in individuals who quit smoking, even after a brief period of time.1,4

Pharmacological treatment

Management of heart disease

can vary widely depending on the clinical situation. However, effective pharmacological management is integral to preventing and managing cardiovascular disease and improving heart health, with some commonly-used pharmacological options outlined below. 2

Antihypertensive drugs

Hypertension is one of the principal causes of increased cardiovascular disease. Lowering blood pressure reduces the risk of cardiovascular disease and prevents complications in patients with heart failure, coronary artery disease, stroke, and diabetes. Normal blood pressure is considered a systolic blood pressure of less than 120mmHg and a diastolic blood pressure of less than 80mmHg. The target blood pressure for someone with hypertension can vary slightly depending on the clinical indication, but most targets are lower than 130/80mmHg. There are multiple classes of medications used to treat hypertension, which should be used in combination with lifestyle modifications.5

Calcium channel blockers are a firstline treatment for hypertension. They work by blocking calcium influx in the heart and vascular smooth muscle. This reduces cardiac contractility and causes vasodilation, thereby reducing blood pressure. They reduce all cardiovascular events except heart failure, with amlodipine and lercanidipine being commonly-used calcium channel blockers to treat hypertension. 4

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) are first-line treatment option for hypertension. They are particularly useful in patients with chronic kidney disease and heart failure. Both classes of drugs work by inhibiting the renin‐angiotensin system (RAS), with ACE inhibitors inhibiting the conversion of angiotensin I to angiotensin II and ARBs blocking the receptor binding of angiotensin II to its target receptors. Both classes share similar efficacy and indications for treatment.

Examples of ACE inhibitors include ramipril, perindopril, lisinopril and enalapril, while examples of ARBs include valsartan, losartan, telmisartan, olmesartan and candesartan. 4

Thiazide and thiazide-like diuretics are also a first-line therapeutic option for hypertension. They inhibit the reabsorption of sodium in the distal convoluted tubule of the nephron, promoting diuresis and sodium loss. They may also be useful in reducing oedema associated with heart failure. Hydrochlorothiazide, chlorthalidone and indapamide are often used to treat hypertension. 4

Lipid-lowering therapy

Lipid-lowering therapies are beneficial for patients at an increased risk of cardiovascular events. Abnormally high levels of low-density lipoprotein (LDL) can contribute to atherosclerosis, which is characterised by the development of lesions in the walls of arteries.

Atherosclerosis is a major cause of coronary artery disease, stroke and

myocardial infarction.

High-density lipoprotein (HDL), also known as 'good cholesterol', is involved in preventing the build-up of plaques in the arteries and reducing cardiovascular events. Therefore, the main objectives of lipid-lowering therapies are to reduce LDL and increase HDL. Statins are the firstline lipid-lowering agents. Other agents may be used to enhance the efficacy of statins, in cases of statin intolerance or in cases of severe hypertriglyceridemia. Similar to hypertensive agents, lipid-lowering therapy should be used in combination with lifestyle modifications. 6

Lipid-lowering therapies are beneficial for patients at an increased risk of cardiovascular events

Statins are the first-line lipidlowering agents, as they can lower LDL and triglyceride levels and increase HDL levels. Statins reduce the risk of cardiovascular events in high-risk patients. They are competitive inhibitors of hydroxymethylglutaryl (HMG) CoA reductase, an enzyme involved in a crucial step of cholesterol biosynthesis. Atorvastatin, rosuvastatin, pravastatin and simvastatin are commonly used statins. Ezetimibe is not a statin, but it is a drug used to treat high cholesterol and other lipid abnormalities. It works by impairing dietary and biliary cholesterol absorption in the intestine, thereby lowering LDL. 6

Role of the pharmacist

Heart health is a major public health concern in Ireland that requires a comprehensive and collaborative approach to prevention and

management. Pharmacists are well-positioned to positively impact cardiovascular health through patient education, monitoring, medication optimisation, and counselling on lifestyle modifications.

Pharmacists address modifiable risk factors by providing advice on the importance of diet and weight management, while also encouraging participation in smoking cessation programmes. They can optimise medication regimens by conducting medication reviews to identify drug interactions and by stressing the importance of adherence to prescribed therapies. Pharmacists can also monitor patients by performing blood pressure, cholesterol, and blood glucose checks.

In conclusion, pharmacists make a significant contribution to preventing cardiovascular disease, improving patient outcomes, and reducing the burden of heart disease on the healthcare system. ●

References

1. Summary of Primary Prevention of Cardiovascular Disease Best Practices and Lessons for Ireland Summary. (2023)

2. Lopez EO, and Jan A (2023). Cardiovascular Disease. [online] National Library of Medicine.

3. Brown JC, Gerhardt TE, and Kwon E (2023). Risk factors for coronary artery disease. [online] PubMed.

4. Rippe JM (2018). Lifestyle Strategies for Risk Factor Reduction, Prevention, and Treatment of Cardiovascular Disease. American Journal of Lifestyle Medicine , [online] 13(2), pp.204–212.

5. Khalil H, and Zeltser R (2023). Antihypertensive Medications. [online] PubMed.

6. Chhetry M, and Jialal I (2021).

Lipid Lowering Drug Therapy. [online] PubMed.

Stories of the marginalised on canvas

The Vanquished Writing History, a new body of work comprising 18 large-scale portraits by artist Paul MacCormaic, are portraits of people, or their advocates, who find themselves marginalised, ostracised, vilified or disbelieved, and who have told their own story, making a positive contribution to Irish society, usually through activism or advocacy. Paul MacCormaic’s body of work enters the fray on the issue of those who challenge society’s structures. MacCormaic takes the tropes of traditional portraiture and places it in the service of these agitators. The exhibition is currently taking place at the Royal Hibernian Academy of Arts (RHA Gallery), 15 Ely Place, Dublin 2. The exhibition takes place from 21 February to 23 March. Admission to the RHA Gallery is always free and the exhibition will be supported by a full colour catalogue, available to purchase at the RHA, at €15.

www.paulmaccormaic.com

#TheVanquished www.rhagallery.ie

1. Martin Collins, traveller rights activist, at his desk in Pavee Point, 2024 Acrylic and oil on canvas 122 x 92cm, Image courtesy of the artist.

2. The Kavanagh Sisters Making Their Podcast, 2023 Acrylic and oil on canvas, 122 x 168cm, Image

courtesy of the artist.

3. John Teggart, victim’s campaigner, at Springhill Community House, Belfast, 2024 Acrylic and oil on canvas, 122 x 92 cm, Image courtesy of the artist.

4. Antoinette Keegan, spokesperson for the Justice for the Stardust

48, 2023 Acrylic and oil on canvas, 122 x 122cm, Image courtesy of the artist.

5. Martin and Peggy Murphy, survivors of thalidomide, at their farm in Co Cork, 2024, Acrylic and oil on canvas, 122 x 122 cm, Image courtesy of the artist.

Cupra’s new SUV brings the brand into the mainstream

Slowly but surely, the Cupra brand is evolving. The name was originally used on the sportiest of SEAT’s models before the Volkswagen Group reinvented it as an entirely new entity. That was back in 2018, and while there have been plenty of new models for the striking Cupra badge to adorn, all could still be considered ‘sporty’ in nature, restricting their appeal to a certain cohort of buyers. Until now. Cupra’s newest vehicle is the Terramar, a five-door, five-seat SUV using the same underpinnings as the Volkswagen Tiguan to bring the Spanish brand slap-bang into the mainstream.

Exterior design and image

Thankfully, Cupra hasn’t abandoned its edgy sense of style completely and, while the Terramar is attractive rather than massively distinctive, it retains some of the brand’s characteristic touches, such as copper-coloured accents, a fullwidth rear light, and a triangular design motif running through it all.

In line with Cupra’s house style, bright colours are few and far between on the palette of available hues, but there are some eye-catching paint options to consider, including Dark Void, which is somewhere between black and purple. It’s not as ‘out there’

as it sounds and actually suits the handsome lines of the Terramar.

Interior and practicality

The copper accents continue inside to good effect, used sparingly, but enough to make the cabin feel special. We particularly like the smooth trim piece that lines-up with the interior door handles as it looks good and is tactile to the touch. Perhaps of more note is the sense of quality, as all the interior materials are solid and premium-feeling. It comes as no surprise to hear that the Terramar is manufactured in an Audi factory in Hungary.

A chunky flat-bottomed steering wheel reminds the driver of Cupra’s sporty beginnings and we love the prominent stitching in the leather rim. It also features an engine-start button and another for selecting the driving mode. Behind it is a set of clear, customisable digital instruments, complemented by a high-set touchscreen packed with the latest in-car connectivity functions. One of our few gripes with this slick setup is that the cabin temperature is controlled either through the screen or via a slider at its base; we prefer physical buttons and knobs for this.

Of course, by moving so many controls to the touchscreen, there’s plenty of room freed-up for odds and ends, and the space between the front seats is cleverly laid out to make the most of this. A cooled wireless smartphone charger is also a welcome addition.

Those in the back may not benefit from the same comfortable bucket seats as those up front, but it’s not a bad place to while away a long journey. Air vents and USB ports in the rear help keep everyone happy, while there’s loads of headroom and legroom. The wide back seat can even accommodate three adults, or bulky baby seats as will often be the case.

As expected in this sector, the rear seat backs can fold down to allow carrying of larger items, though the boot is a decent size even before you do that. Just watch

out for the fact that the plug-in hybrid models have a smaller boot than the purely petrol ones, as that’s where the drive battery is packaged.

On the road

Our first chance to drive the Terramar was at the wheel of the most powerful of two plug-in hybrid (PHEV) variants. And buyers that previously dismissed a PHEV on the grounds of it attempting to offer the best of both worlds, but failing to do either one well – in terms of zero-emissions driving like an electric car on one hand, but the ability to drive long distances without charging up on the other – should give the technology another go in the Terramar, as it features a large battery pack and the ability to travel up to 122 kilometres on electric power alone. That’s the official figure, admittedly, but our experience shows that it should manage nearly 100km in all conditions, which means it wouldn’t even have to be charged twice a week.

As with all such cars, the Terramar is at its best on electric power. It’s smooth, it feels like an electric car in terms of effortless performance, and it’s incredibly quiet. Well-judged suspension adds to

the experience, as it’s comfortable yet still competent in the corners, and this is undoubtedly the most refined Cupra yet in terms of isolating wind roar and road noise from the occupants’ ears. Even when the petrol engine is required, it’s never raucous. And with up to 272hp at your disposal, it lives up to the Cupra image when you feel the need.

Pricing

The entry-level Terramar is priced at €44,900. It’s powered by a turbocharged 1.5-litre petrol engine making 150hp and like all versions uses a dual-clutch automatic transmission. There’s a 204hp eHybrid PHEV in the same specification for €53,340, or the more powerful hybrid variant as tested in the sportier ‘VZ’ trim line at €57,045. In between is the sole all-wheel-drive model, also in VZ spec, but using a turbocharged 2.0-litre petrol engine for a peak of 265hp – that costs €55,385. Some will lament the lack of a diesel option, but Cupra is a forward-looking brand and expects demand for diesel to wane while PHEVs gain popularity. Given its evolution to date, we wouldn’t bet against Cupra’s assessment of the market. ●

From false teeth to Freudian psychology

Prof Brendan Kelly reviews a new book that sheds light on neglected aspects of the Grangegorman story

The history of St Brendan’s Hospital at Grangegorman in Dublin is the subject of increasing attention since its recent reinvention as the campus of TU Dublin. It is an extraordinary story.

The Richmond Asylum (as it was first known) opened in 1814 and served as one of Ireland’s earliest psychiatric institutions. Initially intended to provide care for Dublin’s mentally ill, it expanded to become one of the largest ‘mental hospitals’ in Europe.

Throughout the 19th and 20th Centuries, the asylum witnessed dramatic changes in attitudes toward mental illness, eventually moving away from custodial care and towards community-oriented approaches. By the late 20th Century, mental health reforms led to downsizing, with communitybased care becoming the norm. St Brendan’s finally closed in 2013.

The history of this institution can be told in many ways. Perhaps the most powerful way is through the stories of its patients and staff members. Over the 199 years that it operated as a psychiatric hospital, Grangegorman bore witness to the struggles of tens of thousands of people. Many patients were mentally ill, but many were not. Some were just troubled by life circumstances. While they likely needed assistance and support, committal to a psychiatric hospital was excessive for most and entirely inappropriate for others.

Against this background, Dermot Bolger’s new novel, Hide Away, sheds light on neglected aspects of the Grangegorman story in a new and

exciting way. This book richly rewards reading and reflection. This is not surprising: Bolger is one of Ireland’s bestknown and widely admired writers. This novel further confirms that status.

Bolger has already written some fifteen novels, including The Journey Home, The Family on Paradise Pier, Tanglewood, and The Lonely Sea and Sky. He is also a poet and playwright.

Bolger’s new novel does not disappoint. The story commences behind the walls of Grangegorman in 1941 as the lives of four different people collide, all affected in various ways by the events that surround them. The War of Independence looms large in the tale, as two veterans with very different experiences after the war are reunited. The character of the doctor, Doctor Fairfax, is also well drawn, and the complexity of his position within the asylum is apparent.

There is a lot to savour in this book. The central narratives are involving and credible, and the exploration of the impact of the War of Independence is sensitive and unsparing. This is an episode of Irish history that merits re-examination, including the role of the mental institutions within the societies that founded and sustained them for so long.

In addition to the main plotline, there is much to value in the rich, detailed texture of this book. Everything from false teeth to Freudian psychology makes an appearance, and a great deal in between. The atmosphere of the asylum is deftly conveyed, along with the essential humanity of the characters. As is customary in his work, Bolger avoids simple answers to complex questions. He tells his story vividly and well. We draw our own conclusions. In the case of our asylums, those conclusions are far from clear and certainly not simple. As a result, it is reassuring that there is growing interest in these histories. The past decade has seen a particular focus on St Brendan’s, most notably through Grangegorman Histories . This is a public history programme of research and shared discovery of the Grangegorman site and surrounding communities, with an excellent website ( https:// www.ria.ie/research-programmes/ grangegorman-histories/ ).

Dermot Bolger’s new novel adds significantly to the overall exploration of neglected dimensions of the history of Grangegorman. The book highlights an important period in the existence of this institution. It also shines a light on a complicated, contested passage in our national story. ●

Hide Away, Dermot Bolger, New Island Books (ISBN 978-1848409385).

Brendan Kelly is Professor of Psychiatry at Trinity College Dublin and author of The Modern Psychiatrist’s Guide to Contemporary Practice: Discussion, Dissent, and Debate in Mental Health Care (https://www.taylorfrancis. com/books/oa-mono/10.4324/9781003378495/ modern-psychiatrist-guide-contemporarypractice-brendan-kelly).

Alexion and DHL Express switch to sustainable aviation fuel for international air delivery of medicines

Alexion, AstraZeneca Rare Disease, and DHL Express recently announced a landmark partnership to reduce greenhouse gas emissions (GHG) from the air freight of highly specialised medicines manufactured in Ireland.

Alexion is the first company in Ireland to sign up to a 100 per cent switch from traditional aviation fuel to sustainable aviation fuel (SAF). This alternative fuel will reduce GHG emissions by over 80 per cent on average compared to traditional aviation fuel. The greener fuel will be switched on all European air freight shipments across 19 European countries.

Provided through the DHL GoGreen Plus service, SAF is used as a substitute to conventional fuel and can readily be used as a drop-in replacement in aircraft without the need for modifications to aircraft engines. Produced from waste and residuebased feedstock, such as used cooking oil, SAF has improved sustainability compared to traditional fossil jet fuel which is primarily derived from crude oil.

Reducing the GHG emissions associated with the transport of medicinal products is an important part of AstraZeneca’s

wider sustainability strategy. This includes a focus on partnerships across the healthcare sector, including supply chain decarbonisation. From 2030, the aim is to halve the entire value chain footprint (absolute Scope 3 GHG emissions), from a 2019 base year, on the way to becoming science-based net zero by 2045.

Sylvia Kiely, Vice President, Global Supply Chain and Product Strategy Lead, Alexion, AstraZeneca Rare Disease, said: “Moving our air freight to SAF is an important

Teva launches fluticasone furoate teva

Teva Pharmaceuticals is pleased to announce the launch of Fluticasone Furoate Teva 27.5 micrograms/spray, nasal spray, suspension. This product is indicated in adults, adolescents and children (6 years and over) for the treatment of the symptoms of allergic rhinitis. For any queries or further information, please contact your local Teva

representative. Further product information is available upon request or from the SmPC available at HPRA.ie. Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com.

milestone in reaching our Scope 3 targets, with the ambition of being science-based net zero by 2045.

Through our partnership with DHL Express, we’ve signed up immediately to a 100 per cent change in fuel, rather than scaling up over time, which demonstrates how seriously we take environmental stewardship.”

Brian Murray, Commercial & Same Day Director, DHL Express Ireland, said: “We are thrilled to partner with Alexion. Our GoGreen Plus service using emission-reduced SAF demonstrates the tangible impact of collaborative efforts to decarbonise the logistics industry and support our customers in achieving their sustainability goals. This initiative aligns perfectly with DHL’s sustainability strategy and our goal to achieve net-zero emissions by 2050.”

Countries receiving the medicines under the GoGreen Plus service include Austria, Belgium, Denmark, Estonia, Finland, France, Georgia, Germany, Guernsey, Iceland, Ireland, Italy, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden, and the UK.

Buscopan Rx 10mg coated tablets: Withdrawal notification

Buscopan Rx 10mg coated tablets PA23180/022/001 (Hyoscine Butylbromide) prescription product from Clonmel Healthcare has been discontinued and is no longer available on the Irish market.

Buscopan 10mg coated tablets PA23180//016/002 continue to be available without prescription. Should you have any queries please contact Clonmel Healthcare on 052 617 7777 or email info@clonmel-health.ie.

Brian Murray, Commercial & Same Day Director, DHL Express Ireland; and Sylvia Kiely, Vice President, Global Supply Chain and Product Strategy Lead, Alexion, AstraZeneca Rare Disease

€63.84 million to accelerate commercialisation of

Minister for Further and Higher Education, Research, Innovation and Science, James Lawless TD, recently announced a multi-annual ‘Accelerating Research to Commercialisation’ (ARC) Hub investment programme to fast-track the commercial potential of scientific research across Ireland.

The new programme establishes two new Research Ireland ARC Hubs – the ARC Hub for Therapeutics, and the ARC Hub for ICT. With funding from the European Regional Development Fund (ERDF) and the Government of Ireland, the two hubs have been awarded a combined budget of €63.84 million.

Speaking at the announcement, Minister Lawless said: “The Research Ireland ARC Hubs for Therapeutics and ICT represent a new model for regional innovation and entrepreneurial training that will catalyse a step-change in the translation of cuttingedge, publicly-funded research towards

impact at a regional level. The ARC Hubs will enhance and accelerate the commercialisation of research to create new products, processes and services.”

research across Ireland

Welcoming the announcement, Research Ireland’s Interim CEO, Celine Fitzgerald, commented: “The Research Ireland ARC Hub Programme is a game-changer in terms of driving regional development through commercialisation of research. The two ARC Hubs unveiled today –Therapeutics and ICT respectively – will create regional entrepreneurial ecosystems in two critically important sectors for the Irish economy. Accelerating the overall journey to impact will be achieved by enabling researchers with novel ideas to become future entrepreneurs, with the Hubs providing an integrated approach to research funding, entrepreneurial training and access to networks and supports.”

The ARC Hubs are co-funded by the

Government of Ireland and the European Union through the Southern, Eastern and Midland Regional Programme 2021-2027, one of two ERDF programmes in Ireland. The ERDF aims to promote economic, social and territorial cohesion across all European regions.

Maciej Berestecki, European Commission Spokesperson, commented: “The European Commission welcomes this strategic investment to be co-funded by the European Regional Development Fund. The ARC Hubs offer an integrated approach which will not only accelerate the commercialisation of research but also improve regional competitiveness. By embedding entrepreneurial approaches into the research and innovation ecosystem, groundbreaking ideas can be developed and lead to tangible economic and societal benefits for all regions across Ireland.”

Citizens’ Jury calls for establishment of regulator to oversee artificial intelligence in healthcare

A Citizens’ Jury on the use of artificial intelligence (AI) in healthcare has published its verdict, setting out a series of 25 recommendations – including transparency and patient choice – for health policymakers on the safe, ethical, and inclusive use of AI in Ireland’s healthcare system.

The jury has also written an Open Letter to the Minister for Health Jennifer Carroll MacNeill and to the Minister for Enterprise, Tourism, and Employment Peter Burke, setting out the need for an independent regulator and commissioner to oversee AI, alongside a national strategy to chart the course of AI in healthcare over the next five years.

Organised by IPPOSI – the Irish Platform for Patient Organisations, Science, and Industry – the jury of 24 individuals, representative of the population of Ireland, convened from September to December

2024 to offer the public’s perspective on this complex topic.

NEED FOR STATUTORY REGULATOR AND INDEPENDENT COMMISSIONER

Jurors endorsed the early, low-risk deployment of high-quality, humanmonitored AI tools in helping alleviate pressures on the healthcare system, in pioneering advances in treatment and care, and in empowering individuals to take a more active role in their own health.

However, in so doing, the jury emphasised the need for strong regulation, transparent oversight, and robust data security. In this regard, one of the key recommendations agreed by the jury to build public trust in AI is for the establishment of a statutory regulator to oversee the use of AI in healthcare.

This body would be responsible for developing and enforcing standards for

those using AI, including its licensing, data governance, and monitoring, as well as imposing penalties for breaches. It would also publish compliance reports to advance the development of AI technologies in healthcare that are secure, transparent, and accountable.

To complement the work of the regulator, the jury also called for the creation of a separate independent Commissioner for AI in healthcare to serve as a public interest watchdog and protect patient rights. Their role would be to increase public awareness about how AI is being used in healthcare, make recommendations on the use of individuals’ health data by AI, and independently identify opportunities to strengthen compliance with regulatory standards. The Commissioner would also operate a complaints process for members of the public.

RIGHT TO OPT-OUT

With AI potentially involved in everything from managing waiting lists, to analysing x-rays, to undertaking robotic surgery, the jury emphasised the importance of transparency, patient autonomy, and informed consent. While supporting the automatic enrolment of individual health data for training AI, jurors agreed that people must be clearly informed and given the option to opt out. The jury also recommended that patients have the right to be informed when AI is involved in their healthcare and, where feasible, be given the choice to receive diagnosis or treatment without AI involvement.

OTHER RECOMMENDATIONS INCLUDED:

 Humans in the loop – the jury emphasised the importance of human oversight and control over AI-enabled care. While AI can augment and support clinicians, it cannot replace them.

 Public education campaign – the jury called for a national initiative to communicate to the public about the use of AI across the health system: What it is, what role it plays in care, and how it may involve their personal health data.

 National strategy – the jury suggested that a national strategy detailing the role of AI in healthcare be published by quarter one of 2026, building on the National Artificial Intelligence Strategy

Accord healthcare launch nilotinib accord 150 & 200mg hard capsules

Accord Healthcare is delighted to announce the launch of Nilotinib 150 & 200mg, which come in pack sizes of 112 hard capsules.

Nilotinib Accord is indicated for the treatment of:

 Adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase.

 Adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available.

 Paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.

Please refer to the Summary of Product Characteristics (SPC) for further information. The SPC will be available at www.hpra.ie and for healthcare professionals at www.accord-healthcare.ie from launch.

Nilotinib Accord will be available from both full-line wholesalers from launch. For further information you may contact Accord in Cork on 021-461 9040.

published in 2021. This would provide renewed focus on specific ethical and regulatory considerations within the health sector, as well as on stakeholder rights and responsibilities, timelines for implementation, etc.

Prof Richard Greene of University College Cork, a member of the independent Jury Oversight Panel, is an obstetrician and gynaecologist by profession, as well as the HSE’s Chief Clinical Information Officer.

The full report of the IPPOSI Citizens’ Jury, including the jury’s Open Letter to the Minister for Health and to the Minister for Enterprise, Tourism, and Employment, are available at www.ipposi.ie.

Perindopril Arginine Clonmel

Clonmel Healthcare is delighted to announce the launch of Perindopril Arginine Clonmel 5mg, 10mg filmcoated tablets. Perindopril Arginine Clonmel is indicated for:

 Treatment of hypertension.

 Treatment of symptomatic heart failure.

 Reduction of risk of cardiac events

in patients with a history of myocardial infarction and/or revascularisation. Full prescribing information is available on request or alternatively please go to www.clonmelhealth.ie. Medicinal product subject to medical prescription. Please contact Clonmel Healthcare on 01-6204000 if you require any additional information.

Minister for Health announces implementation of €2 million plan to standardise access to post-mastectomy and hair loss products

The Minister for Health Stephen Donnelly has announced plans to ensure that all women receive the same level of allowance for post-mastectomy and hair loss products after cancer-related treatment, following funding allocations of €1 million for 2024 and €2 million for 2025.

There will be no reduction to the current service provided to anyone and access is provided regardless of medical card eligibility or home location in Ireland. Minister Donnelly said: “I recognise

the challenges faced by many women during and after cancer treatment. I know that these products have an important role in the lives of many people and that reassurance regarding access to them is very much necessary.

“I’m therefore very happy to announce that the HSE has commenced a plan to ensure that access to these products is fair for all women in Ireland who have undergone cancer-related treatment.”

Accessing post-mastectomy and hair

Launch of Reflad 50mg (itopride hydrochloride) for functional dyspepsia

Functional dyspepsia (FD) is a prevalent gastrointestinal disorder characterised by chronic or recurrent upper abdominal discomfort or pain, postprandial fullness, and early satiety, without an identifiable organic cause. While specific data on FD prevalence in Ireland is limited, global studies suggest that FD affects between 7-to-10 per cent of individuals in the 20to-30 year-old age group. Given these figures, it is reasonable to infer that a significant portion of the Irish population may experience FD symptoms. Common symptoms associated with FD are: Postprandial fullness; early satiety; epigastric pain; epigastric burning (with no evidence of structural disease);

nausea and vomiting. Diagnosis of FD is typically based on clinical evaluation and the exclusion of other potential causes of dyspepsia. The Rome IV criteria are commonly used to define and classify FD, along with guidelines from The British Society of Gastroenterology.

Itopride hydrochloride is a prokinetic agent used to enhance gastrointestinal (GI) motility, particularly in conditions like functional dyspepsia. Its mechanism of action involves two primary pathways.

First is the dopamine D2 receptor antagonism in which:

 Dopamine in the GI tract inhibits the release of acetylcholine, a neurotransmitter that promotes muscle

contractions.

 By antagonising dopamine D2 receptors, itopride prevents this inhibitory effect, leading to increased acetylcholine availability and enhanced GI motility.

Secondly, acetylcholinesterase inhibition:

 Itopride inhibits acetylcholinesterase, the enzyme responsible for breaking down acetylcholine.

 This inhibition results in higher acetylcholine levels, further promoting GI peristalsis and facilitating gastric emptying. Through these combined actions, itopride effectively enhances GI motility, alleviating symptoms associated with reduced gastric emptying and improving overall digestive function.

loss products: A woman goes to a HSE approved supplier and purchases a product. Any cost up to the allowance is discounted from the cost paid. If the cost of the product is below or at the level of the allowance, the woman pays nothing. If it is higher, she pays the difference. There is a higher allowance for those who have undergone a double mastectomy. After the product has been supplied to the woman, the supplier makes a claim to the HSE for reimbursement.

Teva launches Fingolimod Teva

Teva Pharmaceuticals, one of the largest suppliers of generic medication in Ireland, is pleased to announce the launch of Fingolimod Teva, a generic hightech prescription medication for multiple sclerosis. Fingolimod Teva is available in 0.5mg hard capsules (28 capsules). For any queries or further information, please contact your local Teva representative. Further product information is available upon request or from the SmPC available at HPRA. ie. Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Teva UK Limited on 00 44 207 540 7117 or medinfo@tevauk.com.

Break the habit with Varenicline Teva

Varenicline (alone or in combination with nicotine replacement therapy (NRT)) is recommended by the HSE as first-line treatment for smoking cessation.1

Available on private prescription only.

Varenilcine 0.5mg and 1mg Film-Coated Tablets Abbreviated Prescribing Information Presentation: Each film-coated tablet contains varenicline citrate equivalent to 0.5mg and 1mg varenicline. Indications: Varenicline is indicated for smoking cessation in adults. Dosage and administration: Oral use. Adults: The recommended dose is 1mg Varenicline twice daily following a 1-week titration (see SmPC for details). Children: Not recommended for use. Elderly: No dosage adjustment is necessary. Elderly patients are more likely to have decreased renal function, prescribers should consider the renal status of an elderly patient. Renal impairment: No dosage adjustment is necessary for patients with mild (estimated creatinine clearance >50ml/min and ≤80ml/min) to moderate (estimated creatinine clearance ≥30ml/min and ≤50ml/min) renal impairment. For patients with severe renal impairment (estimated creatinine clearance <30ml/min), the recommended dose of Varenicline is 1mg once daily. Hepatic impairment: No dosage adjustment is necessary. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions and warnings: Physiological changes resulting from smoking cessation, with or without treatment with Varenicline, may alter the pharmacokinetics or pharmacodynamics of some medicinal products, for which dosage adjustment may be necessary (examples include theophylline, warfarin and insulin). As smoking induces CYP1A2, smoking cessation may result in an increase of plasma levels of CYP1A2 substrates. Changes in behaviour or thinking, anxiety, psychosis, mood swings, aggressive behaviour, depression, suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with Varenicline. Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal. Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking with or without treatment. If serious neuropsychiatric

Teva Pharmaceuticals Ireland, Digital Office Centre Swords, Suite 101 - 103, Balheary Demesne, Balheary Road, Swords, Co Dublin, K67E5AO, Ireland.

Freephone: 1800 - 201 700 | Email: info@teva.ie Prescription Only Medicine.

symptoms occur whilst on Varenicline treatment, patients should discontinue Varenicline immediately and contact a healthcare professional for re-evaluation of treatment. Smoking cessation, with or without pharmacotherapy, has been associated with exacerbation of underlying psychiatric illness (e.g. depression). In clinical trials and post-marketing experience there have been reports of seizures in patients with or without a history of seizures, treated with Varenicline. Varenicline should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold. At the end of treatment, discontinuation of Varenicline was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients. In such instances, tapering should be considered. Patients taking Varenicline should seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke. Interactions: Varenicline has no clinically meaningful drug interactions (see SmPC for further details). No dosage adjustment of Varenicline or co-administered medicinal products listed below is recommended. In vitro studies indicate that Varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes. Furthermore, since metabolism of Varenicline represents less than 10% of its clearance, active substances known to affect the cytochrome P450 system are unlikely to alter the pharmacokinetics of Varenicline, therefore a dose adjustment of Varenicline would not be required. Varenilcine is not known to affect the pharmacokinetics of metformin, digoxin, bupropion and warfarin. Co-administration of cimetidine, with Varenicline increased the systemic exposure of varenicline by due to a reduction in varenicline renal clearance. In patients with severe renal impairment, the concomitant use of cimetidine and Varenicline should be avoided. Pregnancy and lactation: As a precautionary measure, it is preferable to avoid the use of varenicline during

pregnancy. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with varenicline should be made taking into account the benefit of breast-feeding to the child and the benefit of varenicline therapy to the woman. Effects on ability to drive and use machines: Varenicline may have minor or moderate influence on the ability to drive and use machines. Varenicline may cause dizziness, somnolence and transient loss of consciousness, and therefore may influence the ability to drive and use machines. Adverse reactions: Diabetes mellitus, suicidal ideation, depression, hallucinations, psychosis, seizure, cerebrovascular accident, transient loss of consciousness, myocardial infarction, angina pectoris, tachycardia, atrial fibrillation, electrocardiogram ST segment depression, gastritis, haematemesis, severe cutaneous reactions including Stevens Johnson Syndrome and Erythema Multiforme, angioedema. Very Common: Nasopharyngitis, abnormal dreams, insomnia, headache, nausea. Common: Bronchitis, sinusitis, weight increased, decreased appetite, increased appetite, somnolence, dizziness, dysgeusia, dyspnoea, cough, gastrooesophageal reflux disease, vomiting, constipation, diarrhoea, abdominal distension, abdominal pain, toothache, dyspepsia, flatulence, dry mouth, rash, pruritus, arthralgia, myalgia, back pain, chest pain, fatigue, liver function test abnormal. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: In case of overdose, standard supportive measures should be instituted as required. Legal category: POM. Marketing Authorisation Number: 0.5mg PA1986/129/001, 1mg PA1986/129/002. Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands. Job Code: MED-IE-00084. Date of Preparation: July 2024.

References: 1. Stop Smoking. National Clinical Guideline No. 28, 2022.

Further information is available on request or in the SmPC. Product Information also