Irish Pharmacist Feb 2025

VOL 26 ISSUE 2 : FEBRUARY 2025

HARD TO SWALLOW Áine Mac Grory on how the tiers on the community pharmacy cake are collapsing

CLINICAL CONTENT

CPD Module: RSV and Vaccination Also clinical content on: IBD Adult Nutrition Wound Care

E VE RY BODY 'S CONCE RN Dr Clare Sweeney writes about medication errors and how they can be avoided

DRACMA PUBLICATION 20221

“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””

Only Nutricia’s SYNEO range contains prebiotics and probiotics (synbiotics): TM

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Clinically proven to restore the gut microbiome in infants with cow’s milk allergy,2-6 supporting immune development and long-term health7-10

Visit our sampling service at www.nutricia.ie or scan the QR code

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. . Wopereis 8 H et al. Pediatr Allergy Immunol. 2014;25:428–38.

9. West CE et al. J Allergy Clin Immunol. 135(1):3–13.

10. Walker 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

EDITORIAL

Stoicism under stress

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t time of writing, the new Government (if it can be described as such) is beddingin. In the true spirit of Irish politics, one of their first points of action was to propose adjourning the Dáil for two weeks after the Government is formally elected. This, bearing in mind that we basically have not had a functioning Government for months.

Micheál Martin and Leo Varadkar again pass the 'Taoiseach' and 'Tánaiste' hats to each other, and around we go again. 'Meet the new boss — same as the old boss.'

Pharmacy will face many challenges over the term of this Government. In turn, the challenge for pharmacists is to surmount these obstacles without stress getting you down.

We all have our own ways to decompress, and one method of everyday living that has gained huge popularity in recent years is stoicism. However, this is far from a modern fad, as readers of Meditations by Marcus Aurelius will know.

Stoicism could be described as an early form of mindfulness. The basic idea is that while we are not in control

of external events, we can control our reactions to them. Easier said than done when someone is banging their fist on the pharmacy counter, but the principle is sound. In its most basic sense, stoicism means maximising positive emotions, minimising negative ones, and honing the best virtues of our own characters. Rather than being a 'passive' way of life, true stoics are people of action.

Marcus Aurelius said: "You have the power over your own mind, not outside events. Realise this, and you will find strength." He also opined: "How much more grievous are the consequences of anger than the causes of it."

If you're not familiar with the concept, stoicism might be worth researching.

If you encourage self-care among your patients, it makes sense to practise what you preach. Failing that, another good way to deal with workplace stress is to have a lengthy recess at Christmas and immediately take two weeks off when you return to work. Nice work if you can get it.

Pat Kelly pat@greenx.ie

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

www.irishpharmacist.ie

VOL 26 ISSUE 2 : FEBRUARY 2025

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CONTENTS

News

26: Terry Maguire

National and international news in pharmacy

Terry looks at the life of Charles Handy, one of his heroes of leadership

14: AD breakthrough?

28: Áine Mac Grory

04: News

The EMA has recommended licensing of a treatment for early Alzheimer's disease

Are the top tiers about to slide off the top of the community pharmacy 'cake'?

17: Do no harm Dr Clare Sweeney writes about medication errors and how they can be avoided or mitigated

20: Covid conundrum A new study focuses on understanding how immune cells behave abnormally in severe Covid-19

Comment

24: Dr Des Corrigan Toxic brain injury is an underrecognised consequence of non-fatal overdoses

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

Life

An overview of Crohn's disease and ulcerative colitis, including the role of the pharmacist

Tom Doorley writes about how butter is making a comeback after years of being demonised

50: Help to heal

60: Care under fire

41: IBD 30: Tomás Conefrey Personal care means striving for community pharmacy with a capital 'C'

22: Fintan Moore Anaphylaxis training was called upon with a recent visit from a teenage girl

In Focus

CPD Module 32: Vaccination Earn 2 CPD points with our module on RSV/Vaccination

GreenCross Publishing was established in 2007.

Publisher and Managing Director: Graham Cooke, graham@greenx.ie © Copyright GreenCross Publishing Ltd 2025.

Considerations in wound care, including common wounds and treatments

54: Fuel for life Micronutrients and macronutrients, oral supplements, and the causes and effects of malnutrition

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.

58: Spread the word

Prof Brendan Kelly reviews a book about the vital role of medics in World War II

Products

61: 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.

NEWS

Gut infection could trigger changes in immune system linked to Alzheimer’s, study suggests A common herpes virus that can cause a chronic gut infection has been linked to changes in the immune system seen in Alzheimer’s disease, in a study published recently in the journal Alzheimer's & Dementia.

Researchers in the US found that the virus, which is found in most people but usually does no harm, can enter an ‘active state’ and trigger a specific type of immune response which has been linked to Alzheimer’s.

Dr Sheona Scales, Director of Research at Alzheimer’s Research UK, commented: “Alzheimer’s disease is incredibly complex, and research is ongoing to understand its causes. This study adds to our growing understanding of the important role our immune system plays in the development of Alzheimer’s.

“This small study found a virus that causes a persistent gut infection may change the immune system, possibly driving the disease processes behind Alzheimer’s. While it’s too early to say

for sure what this means, it could help explain some of the earliest changes that can lead to Alzheimer’s.

“Importantly, this research opens new possibilities for future treatments and ways to diagnose the disease.

If scientists can better understand differences in the immune system in people with Alzheimer’s, they could explore new therapies that target these processes, including the possibility of using antiviral medicines,” she continued.

“This is a promising step forward, but it’s early days. More work is needed to confirm these findings and understand what they mean. At Alzheimer’s Research UK, we’re committed to supporting the science to understand how diseases like Alzheimer’s develop, which is crucial if we are to find a cure.”

Significant uptake of new supervised injecting facility services Recent figures have shown clear demand for services in the country’s first Medically Supervised Injecting Facility (MSIF) in its first months of operation.

Since its opening on 22 December 2024, up to 15 January 2025, there have been more than 300 visits by a total of 108 people to the Merchants Quay Ireland facility at Riverbank House in Dublin City Centre. There were 47 unique visits in its first full week of operation, 88 in the second week, and 106 in the third week, illustrating the need for this vital health-led service.

The majority of people accessing the service (84 per cent) were male, and 16 per cent were female, with the majority aged between 25 and 44. Four-in-five clients (81 per cent) stated that they accessed the service to use heroin. There

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have been six overdoses in the service, five of which were managed through the administration of oxygen alone, while only one case involved administration of naloxone.

The pilot facility commenced operations following the granting of an 18-month licence by Minister for Public Health, Wellbeing and the National Drugs Strategy, Colm Burke under the Misuse of Drugs (Supervised Injecting Facilities) Act 2017.

The MSIF provides a dedicated safe place for people who inject drugs, prioritising their health and social needs and supporting them to engage with healthcare services.

As well as removing drug use from public spaces and reducing associated litter problems, it ensures that people who inject drugs have access to immediate medical intervention. This minimises the

pressure on emergency services including ambulance services and An Garda Síochána, by preventing overdoses or overdose-induced deaths.

Minister Burke said: “We are in the very early stages of this 18-month pilot programme but it is already very encouraging to see how people who require this service are connecting with it.”

CEO of Merchants Quay Ireland Eddie Mullins said: “The early uptake by clients in using the MSIF clearly demonstrates the need for a compassionate, health-led response to addiction. This service is not just about providing a safe, medically supervised space for injecting drugs that saves lives; it offers people who are often marginalised in our society a chance to access vital healthcare and social supports.”

VOL 26 ISSUE 2 : FEBRUARY 2025

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.

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

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.

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: September 2024 | Job Code: FIN-IE-00002 Further information is available on request or in the SmPC. Product Information also available on the HPRA website.

NEWS

‘Say Hello’ to non-invasive screening: New AI tool identifies diabetes using voice analysis The Luxembourg Institute of Health (LIH) Deep Digital Phenotyping Research Unit has developed a voice-based artificial intelligence algorithm capable of detecting type 2 diabetes (T2D) with remarkable accuracy. By analysing subtle vocal changes, this non-invasive and cost-effective method could make diabetes screening accessible to millions, especially in underserved communities, say the developers.

T2D is one of the most pressing current public health problems, with an estimated 400 million undiagnosed cases worldwide. The consequences of delayed diagnosis are severe and can result in further complications like cardiovascular disease and neuropathy, leading to higher healthcare costs and increased mortality. Current screening methods rely on blood tests, which can be costly and logistically difficult in settings with limited resources.

Addressing this challenge, a team of

researchers led by Abir Elbeji and Dr Guy Fagherazzi from the Luxembourg Institute of Health’s Deep Digital Phenotyping Unit has developed an original approach that relies on distinguishing subtle changes in one’s voice. Using advanced machine learning techniques, they identified vocal biomarkers that correlate with T2D, offering a glimpse into the future of non-invasive, scalable, and affordable health screening where T2D could be diagnosed using a simple voice recording.

The study, published on 19 December in the journal PLOS Digital Health and part of the larger Colive Voice programme, analysed speech recordings of over 600 participants in the US. Using artificial intelligence (AI) algorithms, the team achieved a predictive accuracy comparable to the risk score widely used by the American Diabetes Association (ADA). Notably, detection rates were

even better in key demographics, including women over 60 and individuals with hypertension.

"This research represents a major step in diabetes care. By combining AI with digital phenotyping, we are ushering in a more inclusive and costeffective approach to early diagnosis and prevention. The ability to screen for diabetes using a simple voice recording could dramatically improve healthcare accessibility for millions of people around the world," said Dr Fagherazzi.

In the future, the researchers aim to refine the algorithm for early detection of prediabetes and undiagnosed T2D cases. Plans are also underway to expand the programme to other populations and languages. The Colive Voice study, a multilingual and inclusive programme, has already established itself as an early leader in exploring vocal biomarkers for diagnosing various chronic conditions.

IPU welcomes Programme for Government commitments to community pharmacies The Irish Pharmacy Union (IPU) has welcomed the commitments outlined in the newly announced draft Programme for Government, which address key priorities for community pharmacies. While these commitments represent progress, urgent action is essential to turn them into meaningful improvements for pharmacists and patients, said the Union.

Commenting on the Programme, IPU President Tom Murray said: “Community pharmacies are the cornerstone of Ireland’s healthcare system, providing trusted, accessible care to millions annually. However, financial instability,

6

excessive administrative burdens, and the lack of increased services threaten their sustainability. The Programme for Government acknowledges these issues, but we urge immediate action to secure the future of pharmacies and improve patient care.

“Pharmacists have endured nearly two decades of declining professional dispensing fees, placing unsustainable pressure on pharmacy businesses as their running costs continue to rise,” he continued. “The Programme’s commitment to reviewing the fee structure and streamlining reimbursement processes is a step in

the right direction. However, these discussions must conclude within 2025 to provide clarity and stability.”

Mr Murray added: “Investing in community pharmacies delivers proven benefits. It improves patient outcomes, ensures value for money, and enhances primary care accessibility. The IPU is eager to collaborate with the incoming Minister for Health and will be seeking an early meeting to develop and implement these measures. Pharmacists are ready and willing to do more for their patients, provided we receive the necessary resources.”

VOL 26 ISSUE 2 : FEBRUARY 2025

Advertorial content - Latest clinical trial data for Adex Gel

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.

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15 10 5

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+.

37.14

22.56

25 20

Bridges the gap between plain emollients and topical corticosteroids.

18.48

Mild atopic eczema

SCORAD SCORE

40 35

Moderate atopic eczema

Mean SCORAD – Per Protocol Analysis 45

Adex Gel

Adex Gel

does not contain corticosteroids

0

Baseline

Week 2

Week 4

Baseline (N=41) Week 2 (N=40) Week 4 (N=41) Mean

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.

SCORAD Score

Disease Severity

< 25

Mild

25-50

Moderate

> 50

Severe

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.

SCORAD, SCORing Atopic Dermatitis.

Scan for Adex Gel essential information CDLQI, Children’s Dermatology Life Quality Index. and adverse event/incident reporting.

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.

AdexGel.com / AdexGel.ie

www.dermal.co.uk www.dermal.ie

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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.

NEWS

Scientists develop ‘Malteser-like’ molecules with potential applications in targeted drug delivery Scientists from Trinity College Dublin have taken a major step forward in tackling one of the greatest abiding challenges in chemistry, by learning how to programme the self-assembly of molecules in such a way that the end result is predictable and desirable. Their ‘Malteser-like’ molecules could one day have a suite of applications — from highly sensitive and specific sensors, to next-generation, targeted drug delivery agents.

Virtually all the components of biological systems show an extraordinary and precise ability to self-assemble in the exact way they need to in order to produce the molecules that do the billions of vital things that allow organisms to not only survive, but to thrive, in everchanging environments.

But despite scientific advances, researchers are still largely in the dark as to precisely how these processes are governed. The challenge — and tremendous opportunity — for chemists is to decode these processes and then exert control over them to reproducibly programme molecules to do certain things.

We are now closer to that realisation thanks to a landmark piece of work, recently published in the leading international journal of chemistry, Chem.

The work was performed by a team of scientists led by Prof Thorfinnur Gunnlaugsson, based in the Trinity Biomedical Sciences Institute (TBSI), in collaboration with Prof John Boland, based in CRANN. Both groups are part of Trinity College Dublin’s School of Chemistry and the AMBER Research Ireland Centre, while Prof Robert Pal, Department of Chemistry, Durham University, was also a key collaborator.

First author Aramballi Savyasachi said: “We have been able to make amino-acid-based ‘ligands’ whose selfassembly structures vary — predictably and reproducibly — depending on which amino acid we use. Amino acids are known as the building blocks of life, as

8

they combine to make proteins. Different sequences of amino acids build a huge diversity of different proteins, which have billions of different functions.

“With that in mind, it is perhaps unsurprising that different amino acids produce different self-assembly results, sometimes giving a soft, gel-like material, and other times giving much harder ‘Malteser molecules’. What did surprise and delight us was the discovery that we can largely govern the process and the outcome by selecting specific amino acids.

And when we added other molecules, like lanthanide ions, we can tap into luminescence applications.”

Prof Gunnlaugsson added: “There are so many potential applications of this work and as always, a lot more to learn. But the molecules we have developed already could one day be useful in photonics and optical systems, where highly specific sensors are prized, or in highly targeted drug delivery applications.

“For example, key enzymes appear in greater numbers when the body is fighting an infection and start to break molecules down. The products of this molecular breakdown could stimulate activity in such a way that a drug is released where and when it is needed, which would minimise some of the side-effects that come with many less-targeted therapeutics.”

An additional benefit is that it could be possible to potentially monitor activity in the body, in real time, based on luminescence.

Dr Oxana Kotova from the TBSI team added: “Luminescence is a very useful product of some molecular interactions from a biomedical perspective. In collaboration with Prof Robert Pal at the University of Durham, we found that our ‘Malteser-like’ assemblies functionalised with lanthanide ions emit circularlypolarised light. This property can allow for visualisation of site-specific interactions within biological media or find an application in optoelectronic devices.”

“I would like to say that this work was only possible thanks to the multidisciplinary collaboration between chemists, biochemists, materials scientists, and physicists lead by Profs Thorfinnur Gunnlaugsson, John J Boland, Robert Pal, Matthias E Möbius and D Clive Williams.”

Commenting on the significance of the work, Prof Ronan Daly, from the Department of Engineering, University of Cambridge, who was not involved in this study but who is an expert in the field, said: “Engineers and scientists have been pushing the boundaries of manufacturing for a long time, taking materials around us and machining or shaping them into ever smaller and more precise structures.

We can do this ‘top-down’ approach so well that it is used in pretty much every manufactured component you see, all the way down to the micro and nanoscale structures in computer chips.

“Nature, however, never ceases to inspire scientists and engineers, with the incredible ability to create complex molecular structures that somehow click together perfectly at the molecular scale, then those click together at a nano scale and can build up entirely on their own to form things we see and take for granted every day.

“This self-assembly is an incredibly exciting topic of research where we design materials ‘bottom-up’, with molecules naturally coming together to form what we need. It is of course really complicated and very difficult to design and control, we are just not as good as nature yet!

“This is a very exciting, highly rigorous piece of work that gives new insights into this molecular-scale control of selfassembly. This helps the whole field move forward by building our understanding and provides a very repeatable and robust way of making these new nanoscale spheres that may one day be used, for example, in the future of drug delivery, flowing around the body and releasing a target drug or gene therapy to the right location."

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NEWS

Majority of men in Ireland have had relationship ‘impacted by menopause’ Nearly 60 per cent of men in Ireland believe their relationship has been impacted by menopause symptoms, with almost half saying it has had a negative effect on their sex lives, a new survey shows.

A total of 56 per cent of almost 500 respondents also said they would be willing to join workshops or educational programmes to better understand what their partners go through.

The annual online survey by The Menopause Hub questioned men only for the first time to gain an insight into their understanding of the debilitating symptoms many women have to endure.

Its CEO, Loretta Dignam, said that while the results are 'encouraging,' the survey highlights the strain menopause places on relationships and the need for women to talk openly about the effects it has on intimacy.

"Nearly 10 per cent of men surveyed said they considered leaving the relationship, so it shows that menopause can be an extremely difficult time for both people.

"A total of 80 per cent of men say they feel comfortable talking about menopause, and 70 per cent say they feel they can provide emotional support so women have the responsibility to seek help and engagement with men and be open on how they are feeling.

“The male respondents see menopause as a challenging time for women, particularly physically and emotionally, and the fact they recognise that menopause can be such an issue for a woman in all aspects of her life and career is positive, as debilitating symptoms can lead to women having to leave a job they love."

A total of 56 per cent of men admitted that menopause had negatively impacted their relationship, and just over 8 per cent said they had considered ending the relationship.

And at 48 per cent, almost half of

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the respondents said it had negatively affected their sex life. More than seven-in-10 men called for more information on menopause, with most willing to participate in workshops or educational programmes.

The majority of those surveyed agreed that menopause was a 'challenging time for women' and were able to list at least one symptom, including hot flushes, loss of libido, mood swings and extreme fatigue.

Ms Dignam said the research shows that men want to know more about menopause and its symptoms.

"I was surprised and encouraged at the level of understanding that men

said they had about menopause in the survey, which was much better than I had anticipated," she said.

"I'm very heartened that it shows women have male allies when they try and navigate their menopause journey, which can also hugely impact personal and working lives."

The Menopause Hub is Ireland's first dedicated clinic devoted to treating menopausal and perimenopausal symptoms, and has clinics in Mount Merrion, South Dublin, Santry, North Dublin, and Ballincollig, Co Cork. Its sister organisation, Menopause Hub Academy, provides workplace training, policy development and accreditation.

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NEWS

Communities are ‘key in supporting the dying and grieving across the island of Ireland’ Communities across the island of Ireland are key in supporting those who are dying, a paper by Queen’s University researchers states.

Historically across this island, the role of caring for people through serious illness, dying, death and grief was centered in the community. With important advances in palliative and end-of-life care, many people in society now view the responsibility for dying and death as that of healthcare professionals. Dr Lisa Graham-Wisener from Queen’s University’s School of Psychology is one of the paper’s authors.

She explains: “The death rate is expected to more than double across the island of Ireland in the next 20 years, and we also expect an increase in the number of people dying at home.

“It is vital that we recognise the value communities can bring in supporting those facing the challenges associated with serious illness. Communities can complement formal healthcare services by helping to address broader aspects of suffering. For example, through developing networks of practical support for those with serious illness and their families.

“To achieve the highest quality and continuity of care, we argue that entire communities should be empowered to care for people around the end-of-life, supported by our valued specialist and generalist palliative care services and wider civic society.”

The paper, Fostering Compassionate Communities: A Call to Transform Caregiving, Dying, Death and Grieving on the Island of Ireland, puts forward nine recommendations.

It emphasises the need for a mandate for fostering a compassionate communities approach at local government level. This would recognise that caregiving, dying, death and grieving should not be the sole responsibility of health and social care.

The paper also states that individuals facing the challenges associated with serious illness need to encounter

10

compassion in all aspects of their lives, including in schools, workplaces, and trade unions.

Dr Graham-Wisener added: “There are already many excellent examples of compassionate communities initiatives across the island of Ireland. However, dedicated top-down support is needed.

This is necessary to ensure the right environment for further community development and also to achieve the systems-level change needed to mobilise compassion across all sectors of society.”

Officially launched last month at an online event, the paper was commissioned by the All Ireland Institute of Hospice and Palliative Care (AIIHPC), Foyle Hospice, Irish Hospice Foundation, with funding from the Shared Island Civic Society Fund from the Department of Foreign Affairs Ireland (RoI) Society Fund from the Department of Foreign Affairs Ireland and the Public Health Agency (NI).

Karen Charnley, CEO, AIIHPC, welcomed the position paper. She commented: “We are delighted to have commissioned this paper, that sets out clear recommendations for a compassionate approach to supporting people with life-limiting conditions and to dying, death and grieving on the island of Ireland.

“The paper highlights the need to be responsive to the needs of people with serious illness in our communities, and to achieve this, we need to foster strong networks by engaging with agencies and groups including community and civic organisations, local government, government departments, and civic leaders.

“We also need to build on public awareness to achieve more universal recognition of the vital role of Compassionate Communities across the island of Ireland and we look forward to supporting this work in the months and years ahead.”

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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.

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.

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

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

Prescription Only Medicine.

Date of Preparation: October 2024 | Job Code: Vcli-IE-00011 Further information is available on request or in the SmPC. Product Information also available on the HPRA website.

NEWS

'Data can save lives’: New cancer research collaboration launched at University of Limerick A new cancer research ‘node’ launched at University of Limerick will use data to ‘save lives’, it has been announced.

The inaugural All-Island Forum for Cancer Data was held recently at UL, a landmark event that brought together worldrenowned experts in cancer research, data science, genomics, the biomedical industry, and patient advocates to explore innovative uses of data to advance cancer research and improve patient outcomes.

Over 200 delegates were in attendance, including healthcare providers, researchers, policy-makers, industry leaders, and patient organisations.

The event was organised and hosted by the All-Island eHealth-Hub for Cancer and the Limerick Digital Cancer Research Centre, which is based at UL. This All-Island eHealth-Hub for Cancer, funded by the North South Shared Island Programme, is led by Prof Aedín Culhane, Professor of Cancer Genomics at UL and Prof Mark Lawler, Professor of Digital Health, Queen’s University Belfast. Their goal is to strengthen cross-border data sharing and collaboration in cancer data research.

At the event, the All-Island eHealth-Hub for Cancer announced the establishment of an Observational Health Data Sciences and Informatics National Node, the first collection of research institutes of its type on the island of Ireland.

This will facilitate national and international cross-border cancer data collaborations, empowering researchers from the island of Ireland to participate in large-scale, multi-centre cancer studies, while maintaining patient privacy and data security.

Prof Culhane said: “We are excited to organise and host this conference with the Limerick Digital Cancer Research Centre, which is innovating, tackling challenges head-on and pioneering an all-island approach to clinical genomics data infrastructure that will transform cancer care. By connecting data, we connect patients to innovative research, life-

12

changing treatments, and clinical trials.

“This forum represents a unique opportunity for cross-sector collaboration examining innovative and affordable approaches to improve data-driven solutions to enhance outcomes for cancer patients across the island of Ireland.

“Building world-class infrastructure will take time. During this conference we have learnt best practices from world leaders.

Through collaboration, we can harness the collective power of information to accelerate discoveries and improve outcomes for patients in the Mid-West and throughout the island of Ireland.”

Prof Lawler said: “This is a watershed moment for cancer patients on the island of Ireland. Establishing this national node promotes us to the premier league, positioning us to benefit from the latest advances in data-informed cancer research.

“This will empower us to share data across the island and deploy the insights that we uncover to achieve earlier diagnosis, deliver better and more tolerated treatments, and ensure

enhanced quality-of-life and reintegration back into society. Make no mistake — data can save lives.”

The keynote address at the forum was delivered by Associate Prof Paul Nagy, Programme Director of Informatics and Data Science at Johns Hopkins University, USA, who focused on, ‘How Connected Data Saves Lives’.

Prof Nagy's research focuses on developing biomarkers from medical imaging, and his talk explored how connecting clinical imaging data siloes will accelerate clinical research in oncology.

“Medical imaging plays a crucial role throughout oncology from early detection, diagnosis, treatment planning, to assessing the effectiveness of treatment and monitoring. Unfortunately, imaging has traditionally been treated as an isolated silo of data managed separately from clinical treatment information,” Prof Nagy explained.

“Connecting medical imaging directly with clinical treatment data with open standards allows us to vastly accelerate the biomedical research cycle,” he added.

VOL 26 ISSUE 2 : FEBRUARY 2025

This information healthcareprofessionals professionals only This informationisisintended intended for for healthcare only

WHY MEDICATE? MEDICATE? WHY TRYNUTRITION NUTRITION FIRST TRY FIRST

EAACI 2022 recognises that medications

EAACI 2022 recognises used that in medications are often inappropriately the 1 are often inappropriately used in the treatment of GER and GERD in infants treatment of GER and GERD in infants1

APTAMIL ANTI-REFLUX

APTAMIL ANTI-REFLUX

is a unique formulation for the dietary management of refluxformulation and regurgitation in formula-fed infants is a unique for the dietary management of

reflux and regurgitation in formula-fed infants

Thickened with carob bean gum

Thickened with carob bean gum reduces Significantly reflux episodes and Significantlyseverity reduces regurgitation 2 scores reflux episodes and

regurgitation severity

Helps to2 normalise scores oesophageal pH3

Helps to normalise Greater viscosity in the 3 oesophageal pH to stomach compared starch-based feeds4

Greater viscosity in the stomach compared to starch-based feeds4

EAACI: European Academy of Allergy & Clinical Immunology; GER: Gastroesophageal Reflux; GERD: Gastroesophageal Reflux Disease

References: 1. Meyer R et al., Pediatr Allergy Immunol. 2022 Oct;33(10):e13856. doi: 10.1111/pai.13856. PMID: 36282131. 2. Wenzl et al. J Pediatr 2003;111:e355–9. 3. Vandenplas Y et al. Eur J Pediatr 1994;153:419–23. 4. Nutricia Research. Artificial digestion model. Data on file.

IMPORTANT NOTICE: Breastfeeding is best. Aptamil Anti-Reflux is a food for special medical purposes for the dietary management of frequent reflux and regurgitation. It should only be used under medical supervision, after full consideration of the feeding options available including breastfeeding. Suitable for use as the sole source of nutrition for infants from birth and part of aAcademy weaning diet from 6-12 months.Immunology; This productGER: should not be used in combination withGastroesophageal antacids or other thickeners EAACI: as European of Allergy & Clinical Gastroesophageal Reflux; GERD: Reflux Disease and is not suitable for premature infants. Refer to label for details.

References: 1. Meyer R et al., Pediatr Allergy Immunol. 2022 Oct;33(10):e13856. doi: 10.1111/pai.13856. PMID: 36282131. 2. Wenzl et al. J Pediatr 2003;111:e355–9. 3. Vandenplas Y et al. Eur J Pediatr 1994;153:419–23. 4. Nutricia Research. Artificial digestion model. Data on file.

Date of Publication: February 2024. Nutricia Ireland, Deansgrange Business Park, Deansgrange, Co. Dublin.

IMPORTANT NOTICE: Breastfeeding is best. Aptamil Anti-Reflux is a food for special medical purposes for the dietary management of frequent reflux and regurgitation. It should only be used under medical supervision, after full consideration of the feeding options available including breastfeeding. Suitable for use as the sole source of nutrition for infants from birth and Aptamil_AR_A4Ad_JAN23_02.indd 1 diet from 6-12 months. This product should not be used in combination with antacids or other thickeners 07/02/2023 12:34 as part of a weaning

FEATURE | Medications

A paradigm change for early Alzheimer’s disease?

I

The European Medicines Agency has recommended the licensing of lecanemab for early Alzheimer’s disease. Catherine Reilly reports on recent developments

n November 2024, the European Medicines Agency (EMA) recommended the licensing of lecanemab (Leqembi) for early Alzheimer’s disease (AD) following a re-examination of an earlier decision.

The EMA’s new recommendation specifically relates to the drug’s use in a restricted patient population who are less likely to experience amyloid-related imaging abnormalities (ARIA), which involve swelling and potential bleeding in the brain. ARIA is a recognised possible side-effect in patients receiving antiamyloid monoclonal antibody therapies.

Lecanemab has been shown to have a modest effect in slowing cognitive decline in early AD. If the European Commission proceeds to grant marketing authorisation, it will become the first disease-modifying therapy (DMT) for early AD in the European Union (EU).

The drug was co-developed by Eisai and Biogen. A spokesperson for the company commented: “If approved, Eisai will work through the required national reimbursement authority processes to make lecanemab available to eligible people living with early AD in EU countries as soon as possible.”

The EMA is also reviewing an approval application for another DMT for early AD — donanemab (developed by Eli Lilly).

Restricted use

Last July, the EMA’s human medicines committee (CHMP) decided against recommending lecanemab in a broader population of patients with early AD. The CHMP determined that the medication’s effect on delaying cognitive decline did not counter-balance the risk of serious adverse events.

“Although most cases of ARIA in the

14

main study were not serious and did not involve symptoms, some patients had serious events, including large bleeds in the brain which required hospitalisation,” stated the EMA at the time. “The seriousness of this side-effect should be considered in the context of the small effect seen with the medicine.”

In seeking a re-examination, the company proposed to restrict lecanemab’s use to patients with only one or no copy of the ApoE4 gene. These patients are less likely to experience ARIA compared with those with two ApoE4 copies. Notably, however, people with two copies of the gene have a very high risk of developing AD. The CHMP considered subgroup analyses which excluded data from patients who carried two copies of the ApoE4 gene.

In patients treated with lecanemab, 8.9 per cent of those with only one or no

copy of ApoE4 experienced ARIA-Edema, compared with 12.6 per cent of all patients; 12.9 per cent of patients in the restricted population experienced ARIA-Haemorrhage, compared with 16.9 per cent of the broader population.

In regard to patients treated with placebo, the figures were 1.3 per cent (AR- IA-E) and 6.8 per cent (ARIA-H) in the restricted population.

Benefits

According to the EMA, the benefits of lecanemab in the restricted population were in line with those seen in the broader population. For the re-examination, the company provided a subgroup analysis of data from the main study, which included 1,521 patients who had one or no ApoE4 copy out of a total 1,795 patients.

The main measure of effectiveness was a change in cognitive and functional symptoms after 18 months using the

VOL 26 ISSUE 2 : FEBRUARY 2025

Medications | FEATURE

Clinical Dementia Rating-Sum of Boxes (CDR-SB). The CDR-SB scale ranges from 0-to-18, and higher scores indicate greater impairment.

The data from the aforementioned 1,521 patients showed that, after 18 months of treatment, patients treated with lecanemab had a smaller increase in CDR-SB score than those who received placebo (1.22 versus 1.75), indicating slower cognitive decline.

The results of other key measures indicated a similar effect to that seen in the CDR-SB score.

The CHMP concluded that lecanemab’s benefits in slowing down progression of early AD symptoms were greater than its risks in patients who had only one or no copy of ApoE4.

Additional safety measures

The EMA recommendation comes with a number of provisos, including the implementation of risk minimisation measures to reduce the risk of severe and symptomatic ARIA. Patients will require MRI scans to monitor for ARIA prior to initiating treatment and before the fifth, seventh, and 14th dose. Additional MRI scans may be needed during treatment if patients develop symptoms of ARIA. The company will provide a guide and checklist for healthcare professionals, an alert card for patients, and training programmes on ARIA for healthcare professionals. In addition, it must carry out a post-authorisation safety study to further characterise ARIA-E and ARIA-H and assess the effectiveness of the risk minimisation measures.

Controlled access

The EMA stated that lecanemab will be available through a controlled access programme for the recommended patient population. The medication will also be contraindicated in people receiving anticoagulant treatment, for example.

The benefits vs costs of the drug remain the subject of ongoing debate.

In August, the UK’s National Institute for Health and Care Excellence (NICE)

VOL 26 ISSUE 2 : FEBRUARY 2025

published draft guidance which stated the benefits of lecanemab were too small to justify the costs.

According to NICE, lecanemab provided on average four-to-six months slowing in the rate of progression from mildto-moderate AD. It said this “small but meaningful” effect — based on outcomes at 18 months — was not sufficient to justify the additional cost to the NHS. NICE’s final recommendations are awaited.

‘Cautious approach’

A recent statement issued by the Alzheimer Society of Ireland (ASI) on the EMA recommendation captured some of the complexities at play.

It said the fact the EU was on the cusp of its first DMT for AD was a significant moment that “cannot be underestimated”.

The emergence of DMTs for early AD is widely regarded as a significant breakthrough The ASI also stated it was “glad to see” the EMA taking a “cautious approach which protects people at the greatest risk of harmful side-effects”.

However, the ASI added that “we cannot forget the 64,000 people already living with dementia in Ireland who need services and supports to live as well as possible for as long as possible”.

“Leqembi will only be suitable for a relatively small number of people who are in the very early stages of Alzheimer’s disease. There are many for whom this drug will not be suitable, including those living with other types of dementia.”

The HSE National Dementia Office (NDO) has been preparing for the possible introduction of DMTs for AD. In 2022, it convened an expert reference group on preparedness for potential licensing of such agents.

Considerations

Aside from the cost of DMTs, considerations for health systems include the structures required to identify patients, delivering the drug, and monitoring patients.

Currently, anti-amyloid monoclonal antibody DMTs approved in other jurisdictions, or on the approval pathway, require biomarker confirmation of the diagnosis of AD through PET-ligand neuroimaging, or amyloid-tau ratio cutoffs from cerebrospinal fluid, obtained via lumbar puncture.

In addition, delivery of the drug requires intravenous infusion facilities and radiological resourcing to implement serial brain MRI. A recent paper in BMC Health Services Research, which arose from the NDO’s preparatory work, described a hub-andspoke model for DMT service delivery.

This model would utilise the approach outlined in the HSE’s national model of care for dementia (2023).

The paper also noted that when patients present to memory clinics with subjective memory complaints, or mild cognitive impairment, they are often discharged back to primary care without further support or intervention.

“Thus, it is imperative to consider systematic approaches to managing early-stage cognitive decline, since evidence suggests early interventions are associated with larger clinical benefits, and foster potential for access to DMT.” It noted the future delivery of DMTs in Irish healthcare was complicated by longstanding capacity constraints, insufficient universal primary care coverage, and growing waiting lists.

The emergence of DMTs for early AD is widely regarded as a significant breakthrough and may also act as a lever to drive enhancements of diagnostic and care pathways.

However, healthcare professionals and patients hope these developments will pave the way for even more advanced and expansive treatment options for all those impacted by dementia over the coming years. ●

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Patient safety | FEATURE

Medication without harm: A challenge for everybody Medication errors are a common cause of harm. Dr Clare Sweeney writes about the risks posed by medication errors and how they can be mitigated or avoided

E

very year, tens of millions of drugs are prescribed, dispensed, and administered to patients, helping to ease their symptoms and support their recovery. But errors can creep into the process, with the potential to cause serious harm.

The following fictional scenario shows what can go wrong: A consultant saw an outpatient with poorly controlled hypertension. The patient said she was not on any other medication, but did not mention that she was regularly taking over-the-counter ibuprofen for back pain.

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The consultant recommended an ACE inhibitor and explained what to do in the event of side-effects.

When the patient fell ill with gastroenteritis, she continued to take the ACE inhibitor and was later admitted to hospital, where she was found to be suffering from acute kidney injury which required long-term dialysis. She made a claim alleging the consultant should have checked whether she was taking other medications and warned her about the risks of taking NSAIDs and becoming dehydrated.

Priority areas

HIQA has calculated that there may be around three million medication errors per year in Irish public hospitals based on an earlier estimate by the Institute of Medicine (United States).

A number of national initiatives have been launched to tackle the issue, including the Safermeds campaign by the HSE’s Quality and Patient Safety division. The Irish Medication Safety Network also issues regular safety alerts following reported incidents and has

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FEATURE | Patient safety

published Building a Medication Safety Programme in Acute Care in Ireland – Fundamental Steps.

Medication errors are a worldwide problem, with the World Health Organisation (WHO) reporting that harm due to medicines and therapeutic options accounts for nearly 50 per cent of preventable harm in medical care. It has made ‘medication without harm’ a global patient safety challenge. The WHO’s 2024 progress report identified three priority areas: High-risk situations, polypharmacy, and transitions of care.

Reducing risk

A doctor is responsible for all the prescriptions they sign, so it is important to know how to be a safe prescriber. Here are the Medical Defence Union’s (MDU) top tips.

1. Understand common risk factors In the MDU’s experience, the most common medication errors are:  Prescribing to someone with a known allergy, especially penicillin.  The wrong drug. This can happen with sound-alike and look-alike drugs or when selecting from drop-down menus. For example, penicillamine instead of penicillin, or Depo-Medrone instead of Depo-Provera.  The wrong dose. Confusion about the strength (ie, opioids), different formulations of the same drug, frequency (ie, methotrexate), or miscalculating a dose based on body weight.  Failing to consider drug interactions.

For example, a patient on anti-epilepsy medication becomes pregnant.  Failing to monitor patients on long-term medication. As in the case example above, renal function monitoring for patients on ACE inhibitors.

Other high-risk situations include treating frail or very young patients, using high-risk drugs, unlicensed medicines (especially in paediatrics, psychiatry, and palliative care), remote prescribing, and shared care arrangements with the patient’s GP.

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2. Communicate effectively with patients A two-way dialogue will help a doctor take an accurate and complete history (including current medications), obtain informed consent, and provide clear safety netting advice, including:  How and when to take the medication.  How to adjust the dose if necessary.  Likely duration of treatment.  Arrangements for monitoring, follow-up, and review.  What to do if the patient experiences side-effects or a recurrence of their condition.

Engaging with patients is central to the HSE’s ‘Know, Check, Ask’ campaign Engaging with patients is central to the HSE’s ‘Know, Check, Ask’ campaign, which recommends that healthcare workers encourage people on medication to keep an up-to-date list of their medicines and ask whether they have this with them during an appointment.

3. Ensure records are updated To ensure continuity of care, prescriptions should be carefully documented in the patient’s clinical notes, along with the name of the prescribing doctor and relevant details such as allergies, adverse reactions, and poor tolerance of a particular drug.

When patients are discharged, the Medical Council’s Guide to Professional Conduct and Ethics for Registered Medical Practitioners (9th edition) says this “must be accompanied by a timely and prompt discharge summary which includes at least the minimum basic information”, including medication and medication changes (paragraph 33.7).

4. Check monitoring arrangements Pay special attention to high-risk drugs that have been commenced during admission and arrange for newly prescribed medicines to be reviewed within a defined period. A hospital stay is also a good opportunity to review patients’ existing medication to ensure it is clinically appropriate and whether they are experiencing any side-effects or there is a risk of dependency.

5. Keep on top of guidance and procedures Follow your hospital’s prescribing protocols and patient safety systems and refer to authoritative guidance such as the Irish Medicines Formulary.

The Medical Council’s ethical guide covers prescribing and prescribing controlled drugs (paragraphs 34 and 35) and it has published joint guidance on the safe prescribing and dispensing of controlled drugs with the Pharmaceutical Society of Ireland.

6. Respond appropriately to errors and adverse reactions If you identify a prescribing error, give the patient an open and honest explanation of what has happened, apologise, and reassure them of the steps you are taking to put things right (seeking specialist advice if needed).

The Medical Council expects doctors to comply with safety procedures, which includes reporting incidents (via the National Incident Management System), learning from them, and taking part in any subsequent review. Seek advice from your hospital in the event of a medication incident leading to the death of a patient as these are now notifiable under the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, which came into effect in September 2024 (see the HSE’s website for information and resources for staff).

Finally, report adverse drugreactions to the Health Products Regulatory Authority using its online form. ● To find out more, see www.themdu.com/ireland. ●

VOL 26 ISSUE 2 : FEBRUARY 2025

Scalp Scalp psoriasis? dermatitis?

Dandruff?

No problem!

Capasal Therapeutic Shampoo Triple Action Therapy

Salicylic acid removes scales, distilled coal tar relieves itching, and coconut oil softens and moisturises the scalp

Recommend Capasal Therapeutic Shampoo Prescribing information

Salicylic acid 0.5% w/w, coconut oil 1.0% w/w, distilled coal tar 1.0% w/w.

Uses: As a shampoo in the treatment of dry, scaly scalp conditions such as seborrhoeic eczema, seborrhoeic dermatitis, pityriasis capitis, psoriasis and cradle cap in children.

It may also be used to remove previous scalp applications.

Directions: Adults, children and the elderly: Use as a shampoo, once or twice weekly until the condition improves. Thereafter, occasional use may be necessary. Wet the hair thoroughly. Massage a small amount of the shampoo into the scalp, leaving on for a few minutes. Remove as much lather as possible with the hands, before rinsing out thoroughly under running water. Repeat if necessary.

Contra-indications, warnings, side effects etc: Please refer to SPC for full details before prescribing. Do not use if sensitive to any of the ingredients. In case of irritation or if there is no improvement after 4 weeks, or the condition is aggravated, discontinue treatment. Keep away from the eyes. Keep out of the reach of children.

Use in pregnancy: avoid use during first trimester.

Package quantities, trade prices and MA number: 100ml bottle €3.78, 250ml bottle €7.30, PA23128/008/001.

Legal category: Supply through pharmacy only.

Further information is available from: Dermal Laboratories (Ireland) Ltd, Head Office Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK. Date of preparation: June 2024. ‘Capasal’ is a trademark.

Adverse events should be reported.

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

www.dermal.ie

CAPPR038/I/AUG24

Capasal Therapeutic Shampoo ™

FEATURE | Immunology

New research explores dysfunctional immune cells in severe Covid-19

A

A new study focuses on understanding how 'notoriously understudied' immune cells behave abnormally in patients with severe Covid-19

t the beginning of the Covid-19 pandemic, numerous studies had shown that Covid-19 patients with high levels of neutrophils, a key immune cell, presented with more severe disease and poor clinical outcomes. It was not clearly understood how or why this was happening.

A recently published study from Trinity College Dublin researchers sheds light on the role of neutrophils in Covid-19 and its contribution to the disease's progression.

Their findings uncover potential mechanisms that could guide more effective treatments for severe Covid-19, said the researchers.

The study was published in JCI Insight.

It highlights that severe Covid-19 is characterised by an increase in low-density neutrophils (LDNs), a specific type of immature and activated neutrophil, which correlates strongly with disease severity and oxygen dependence. These LDNs show impaired function, including reduced reactive oxygen species production and deficient NET formation.

Intriguingly, while intracellular arginase-1 levels are elevated, its release is blocked, suggesting a potential therapeutic target. Finally, although neutrophils suppress T-cell proliferation, this effect is independent of arginase-1, indicating other immunosuppressive mechanisms are at play.

Neutrophils

Despite being the most abundant immune cells, neutrophils have often been overlooked in research due to the difficulties in studying them. Recent advances, however, are helping us realise their critical role in various diseases, including viral infections, cancer, and autoimmune disorders.

However, in certain instances, neutrophils can malfunction, turning what should be a mild infection into a life-threatening disease, such as in Covid-19. Understanding how

20

neutrophils control Covid-19 severity may help to identify new therapeutic interventions that improve clinical outcomes for these patients.

The team’s key findings include:  Low-density neutrophils: The researchers found that neutrophils from patients with severe Covid-19 have increased levels of a type of abnormal neutrophil called low-density neutrophils (LDNs). In addition, neutrophils from severely ill patients behave and function differently than neutrophils from patients with mild Covid-19 disease. In severe cases, neutrophils are the most immature and dysfunctional, showing defective production of neutrophil extracellular traps (NETs) and reactive oxygen species (ROS), both of which are crucial for the immune response against the Covid-19 causing SARS-CoV-2 virus.  Defective arginase-1 release: One of the most important and unexpected results was the inability of neutrophils from patients with severe Covid-19 to release arginase-1 (a key enzyme involved in suppressing the immune response), despite these cells having elevated intracellular levels of the enzyme. This finding was surprising because arginase-1 is typically released by neutrophils to help resolve inflammation, but in these patients, the lack of arginase-1 release could be contributing to ongoing immune dysfunction and prolonged inflammation.

This defect in arginase-1 release persisted even in convalescent patients, suggesting a long-lasting impact of the disease.  Dexamethasone's role: While dexamethasone, a commonly used corticosteroid, is a standard treatment for severe Covid-19, the study found that it modestly inhibited the release of arginase-1 from neutrophils. This was surprising because while

dexamethasone helps reduce inflammation, it may inadvertently contribute to the neutrophil dysfunction observed in these patients, complicating its role in treating severe Covid-19.

Long-term effects

The study also shows that, even in convalescent patients, neutrophil dysfunction persists, particularly with elevated arginase-1 levels. This indicates that post-recovery care should consider monitoring immune function in patients who have had severe Covid-19, as lingering immune abnormalities could have long-term health effects or contribute to complications.

Dr Conor Finlay, Senior Research Fellow, School of Medicine, and senior author said: “Our work shows the neutrophil, a rather tricky immune cell to study, and often ignored for this reason, might be the most important player in disease severity in Covid-19.”

Prof Mark Little, Professor of Nephrology in the Trinity Kidney Centre and senior author, said: “This work has led us to go on and ask questions about the importance of low-density neutrophils, not just in Covid-19, but in cancer, infection and autoimmunity.”

Dr Amrita Dwivedi, postdoctoral fellow and joint-first author, added: “Findings from this study can have implications beyond Covid-19, providing insights into how severe infections affect neutrophil behaviour and vice versa.”

Dr Aisling Ui Mhaonaigh, Research Fellow, School of Medicine and joint-first author, also commented: “I am delighted to be first author on this paper published in JCI Insight, highlighting the importance of arginase in inflammation. Neutrophils are notoriously understudied in immunology and this paper contributes a novel insight into neutrophil biology in Covid-19.” ●

VOL 26 ISSUE 2 : FEBRUARY 2025

GenericGeneric Product Launch Product Launch

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

Suspension

fluticasone furoate

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).

Indications

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

Fluticasone Furoate Fluticasone Teva 27.5 micrograms/spray, Nasal Spray, Furoate Teva Nasal Spray Abbreviated Prescribing Information.Suspension such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Growth retardation has been reported in children

Presentation: spray actuation in delivers 27.5mcgadolescents of fluticasone furoate. receiving (6 nasalyears corticosteroids licensed doses. A reduction in growth velocity has been Fluticasone Furoate TevaEach is indicated adults, andOne children andatover). 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

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

Fluticasone Furoate TevaDosage is indicated for the treatment of the symptoms allergic allergic rhinitis. and administration: Intranasal route only. Adults, Adolescents adequate of symptom control.rhinitis.

It is recommended that the growth of children receiving

(12 years and over): The recommended starting dose is two spray actuations (27.5mcg prolonged treatment with nasal corticosteroids is regularly monitored. Concomitant of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, administration with ritonavir is not recommended because of the risk of increased 110mcg). Children (6 to 11 years): The recommended starting dose is one spray actuation systemic exposure of fluticasone furoate. Interactions: Fluticasone furoate is rapidly (27.5mcg of fluticasone furoate per spray actuation) in each nostril once daily (total daily cleared by extensive first pass metabolism by the cytochrome P450 3A4.use of Fluticasone Furoate Teva Nasal Spray Abbreviated Prescribing Information. such as central serous chorioretinopathy (CSCR) mediated which have been reported after dose, 55mcg). Children (under 6 years of age): Not recommended for use. Elderly: No Based on data with another glucocorticoid (fluticasone propionate), that is metabolised systemic and topical corticosteroids. Growth retardation has been reported in children dose adjustment required. Renal and Hepatic Impairment: No dose adjustment required.

by CYP3A4, co-administration with ritonavir is not recommended because of the risk Presentation: Each spray actuation delivers 27.5mcg of fluticasone furoate.

One corticosteroids at licensed doses. A furoate. reduction in growth velocitywhen has been Contraindications: Hypersensitivity to the active substance or to any of the receiving excipients. nasal of increased systemic exposure of fluticasone Caution is recommended and warnings: effectsIndicated of nasal corticosteroid occur, inco-administering fluticasone furoate withfuroate potent CYP3A inhibitorsfor including cobicistatactuation delivers 8.25mcg ofPrecautions benzalkonium chloride.Systemic Indications: in adults, may observed children treated with fluticasone 110mcg/day one year.

Therefore, high doses for prolonged periods.

These effects much less should containing products as an in thepossible risk of systemic side effects expected. adolescents and children (6 particularly years andat older) forprescribed the treatment of the symptoms of arechildren be maintained onincrease the lowest efficacious doseiswhich delivers to occur than with oral corticosteroids and may vary in individual patients and Co-administration should be avoided unless the benefit outweighs the increased risk allergic rhinitis. Dosage and likely administration: Intranasal route only. Adults, Adolescents adequate symptom control. It is recommended that the growth of children receiving between different corticosteroid preparations. Potential systemic effects may include of systemic corticosteroid side effects, in which case patients should be monitored (12 years and over): The recommended starting dose is two spray actuations (27.5mcg prolonged treatment with nasal corticosteroids is regularly monitored.

Concomitant Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in for systemic corticosteroid side effects. Pregnancy and lactation: Fluticasone furoate of fluticasone furoate per spray actuation) in eachcataract, nostrilglaucoma once daily (totalrarely, daily dose,of psychological administration with ritonavir is notonly recommended the risk increased children and adolescents, and more a range should be used in pregnancy if the benefits tobecause the motherof outweigh the of potential or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, risks to the foetus or child.

Administration of fluticasone furoate to patients who 110mcg). Children (6 to 11 years): The recommended starting dose is one spray actuation systemic exposure of fluticasone furoate. Interactions: Fluticasone furoate is are rapidly depression or aggression (particularly in children). Treatment with higher than should only be considered if the expected benefit to the patient is (27.5mcg of fluticasone furoate per spray actuation) in each nostril once daily (total daily cleared by breast-feeding extensive first pass metabolism mediated by the cytochrome P450 3A4. recommended doses of nasal corticosteroids may result in clinically significant adrenal greater than any possible risk to the child. Effects on ability to drive and use machines: dose, 55mcg). Children (under 6 years of age):is evidence Not recommended use. Elderly: on data with another glucocorticoid (fluticasone propionate), that isreactions: metabolised suppression.

If there for higher than for recommended dosesNo being Based used, then no or negligible influence on the ability to drive and use machines. Adverse dose adjustment required. Renal and Hepatic No dose adjustment required. byofCYP3A4, co-administration with ritonavir is not angioedema. recommended becauseEpistaxis. of the risk additional systemicImpairment: corticosteroid cover should be considered during periods stress Hypersensitivity reactions including anaphylaxis, Very Common: or elective As with all intranasal corticosteroids, total systemic of burden of Common: Headache, nasal dyspnoea. the is Summary of Productwhen Contraindications: Hypersensitivity tosurgery. the active substance or to any of thethe excipients. increased systemic exposure of ulceration, fluticasone furoate.Consult Caution recommended should beof considered other forms of corticosteroid treatment Characteristics in relation to other effects.

Overdose: In a bioavailability study, Precautions and warnings: corticosteroids Systemic effects nasal whenever corticosteroid may occur, co-administering fluticasone furoate withside potent CYP3A inhibitors including cobicistatare prescribed concurrently. If there is any reason to believe that adrenal function is intranasal doses of up to 2640mcg/day were administered over three days with no particularly at high doses prescribed for prolonged These effects less products as an increase in the riskoverdose of systemic side effects expected. impaired, care must be takenperiods. when transferring patients are frommuch systemic steroidcontaining treatment adverse systemic reactions observed.

Acute is unlikely to require anyistherapy likely to occur than with oraltocorticosteroids and may vary in may individual patients and and Co-administration should be avoided unless the benefit outweighs the increased fluticasone furoate.

Visual disturbance be reported with systemic topical other than observation.

Legal category: POM. Marketing Authorisation Number: risk corticosteroid use. If a patient presents with symptoms such asinclude blurred vision other PA1986/126/001.

Authorisation Holder: B.V., Swensweg 5, 2031GA between different corticosteroid preparations.

Potential systemic effects may oforsystemic corticosteroidMarketing side effects, in which caseTeva patients should be monitored visual features, disturbances, the patient should be considered referral to anin ophthalmologist Netherlands.

Jobeffects.

Code: MED-IE-00087.

Preparation:Fluticasone October 2024. furoate Cushing’s syndrome, Cushingoid adrenal suppression, growth for retardation for systemicHaarlem, corticosteroid side PregnancyDate andoflactation: for evaluation of possible causes which may include cataract, glaucoma or rare diseases

children and adolescents, cataract, glaucoma and more rarely, a range of psychological should be used in pregnancy only if the benefits to the mother outweigh the potential or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, risks to the foetus or child. Administration of fluticasone furoate to patients who are Teva Pharmaceuticals Ireland, depression or aggression (particularly in children).

Treatment with higher than breast-feeding should only be considered if the expected benefit to the patient is Adverse events should be reported. Reporting forms Digital Office Centre Swords, recommended doses of nasal corticosteroids may result in clinically significant adrenal greater than any possible risk to the Effects onfound ability to drive and use machines: and child. information can be at www.hpra.ie.

Suite 101 - 103, Balheary Demesne, Balheary Road, Adverse events should alsoand be reported to Teva UKAdverse Limited reactions: suppression. If there is evidence for higher than recommended doses being used, then no or negligible influence on the ability to drive use machines.

Swords, Co Dublin, K67E5AO, Ireland. on +44 (0) 207 540 7117 or medinfo@tevauk.com additional systemic corticosteroid cover should be considered during periods of stress Hypersensitivity reactions including anaphylaxis, angioedema.

Very Common: Epistaxis.

Freephone: 1800 - 201 700 | Email: info@teva.ie or elective surgery. As with all intranasal corticosteroids, the total systemic burden of Common: Headache, nasal ulceration, dyspnoea. Consult the Summary of Product Prescription Onlyother Medicine.

Date of Preparation: | Job Code: GEN-IE-00109study, corticosteroids should be considered whenever forms of corticosteroid treatment Characteristics in relation to other sideJanuary effects.2025 Overdose: In a bioavailability are prescribed concurrently. IfFurther there isinformation any reasonistoavailable believe that adrenalorfunction is intranasal doses of upalso to available 2640mcg/day administered over three days with no on request in the SmPC. Product Information on thewere HPRA website. impaired, care must be taken when transferring patients from systemic steroid treatment adverse systemic reactions observed. Acute overdose is unlikely to require any therapy to fluticasone furoate. Visual disturbance may be reported with systemic and topical other than observation. Legal category: POM. Marketing Authorisation Number: corticosteroid use. If a patient presents with symptoms such as blurred vision or other PA1986/126/001. Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031GA visual disturbances, the patient should be considered for referral to an ophthalmologist Haarlem, Netherlands. Job Code: MED-IE-00087. Date of Preparation: October 2024. 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.

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.

COMMENT | Opinion

Adrenaline rush

L

Fintan Moore reflects on how his anaphylaxis training was called upon with a recent visit from a teenage girl

ike every pharmacist taking part in the seasonal flu vaccination programme, I keep my CPR and anaphylaxis training up to date. And like the vast majority of pharmacists who do the training, I always had the fervent hope that I’d never actually need to use it. It was filed mentally under the heading of ‘things that I may need to know sometime’, like how to change a flat tyre or how to convince Jehovah’s Witnesses on my doorstep that I don’t understand English. Anyway, I still haven’t had to use my CPR technique, but a few weeks ago I did have to do an emergency adrenaline injection.

As anaphylaxis cases go, this one was probably about as straightforward as they can get, so there wasn’t too much drama involved at my end. The patient’s mother rang ahead to check that we were able to provide the injection, and it took about 10 minutes before she arrived with her teenage daughter, who had a latex allergy.

The daughter said she’d taken an oral nicotine product (I don’t know what one) that caused her mouth and throat to swell. She was a bit out of breath but she was understandably a bit panicky, and also had just walked for about 15 minutes to get to us. On top of that, she had a fear of needles, so she had nearly the full ‘bingo card’ of reasons to be puffed.

Because I had been given the advance warning, I had already got the emergency kit with adrenaline

22

vials, syringes and needles, and had an injection ready to use. Every couple of months I have patients who get Neo-Cytamen injections, which use the exact same technique, so that repeated practice was helpful in terms of getting organised.

I gave the patient a shot in her thigh and she felt better in a couple of minutes. Having had a chance to sit and calm down probably helped her also, and she was well enough to leave shortly after. All in all, it went as smoothly as possible, helped by the patient being well enough to get to me rather than me having to dash from the pharmacy.

As a side note, before coming to me, the girl had gone to another pharmacy who were unable to provide her with an injection, so it’s a good idea for every pharmacy to have a note somewhere of what local pharmacies have somebody trained and who is usually available.

Killing me softly

There’s a lot of chat these days about ultra-processed foods and how bad they are for us, although the picture can sometimes be complicated. For instance, almond milk is ultra-processed but not unhealthy; but generally, foods with more industrialised cheap ingredients are a problem. However, you might be right to worry about ultra-processed foods, but you might be worrying for the wrong reason.

When you look at ingredient lists, you might suspect that the added

fats, oils, sugars and chemicals are somehow toxic. And if you Google enough, you may find some study in rats that shows that this dye or that preservative causes cancer or something. But the real reason why ultra-processed foods are killing us is simpler than that.

VOL 26 ISSUE 2 : FEBRUARY 2025

Opinion | COMMENT

Grains have been stripped of fibre so they are easier to chew and have a better mouth-feel

A study in the US took 20 volunteers and had them stay at the National Institutes of Health for a month. For two weeks they got a normal diet; for two weeks, a diet high in ultraprocessed foods. They could eat as much or as little as they wanted, and the average volunteer ate 500 extra calories per day while on the ultraprocessed diet. These foods kill us, quite simply, because we eat more of them.

These unhealthy foods are now so ingrained in people’s diets, and from such a young age, that the situation is bleak if not actually hopeless.

From a pharmacist’s perspective, as businesspeople it means that we’ll never run short of overweight patients with all the associated comorbidities, and weight-loss products like Ozempic are going to be here for good.

I know that there’s never been more information available to the public on the benefits of eating well, but that’s not translating into what they’re actually doing, so as healthcare professionals, is there any role we can find to help turn the tide? ●

The reason ultra-processed foods are so bad for us is that they are easier to eat. Their additives include chemicals to keep the food fresh longer, so it stays soft if it’s supposed to be soft, crunchy if it’s supposed to be crunchy.

The makers add salts, spices, and oils that taste good. Grains have been

VOL 26 ISSUE 2 : FEBRUARY 2025

stripped of fibre so they are easier to chew and have a better mouth-feel.

These are all designed by very smart scientists to be highly delicious and easy to eat. There is even a term they use for this: Cravability.

They want foods to be as close to addictive as possible, and it works.

Fintan Moore graduated as a pharmacist in 1990 from TCD and currently runs a pharmacy in Clondalkin. His email address is: greenparkpharmacy @gmail.com.

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COMMENT | Opinion

The tip of the iceberg?

I

Dr Des Corrigan lifts the lid on toxic brain injury, an under-recognised consequence of non-fatal overdoses

n last month’s issue, I wrote about the spate of overdoses due to the nitazene group of drugs.

Happily, the vast majority of these did not end up as deaths thanks to the speedy use of naloxone.

While rapid response to overdoses by the emergency services, the Gardaí, families and peers is welcome, it would be short-sighted to believe that those saved from death are always able to walk away without consequences.

International experience suggests that those who survive a non-fatal overdose run the risk of a number of health consequences, including what is increasingly referred to as ‘toxic brain injury’ arising from oxygen deprivation linked to the respiratory depression characteristic of opioid overdose in particular.

Most of our knowledge of this littleunderstood issue comes from North America (USA and Canada), which is not surprising since that is the epicentre of the opioid overdose catastrophe.

Understandably, most attention has to be focused on the appalling death toll — 81,083 opioid-related fatalities in the USA in 2023, and the focus has been on ways to prevent such a waste of lives.

But in addition to this, another area of increasing concern arises from Canada reporting nearly 42,000 emergency medical services responses to suspected opioid overdoses, because of the emerging evidence of the long-term harm that those who survive overdoses may be facing. Now, it is almost impossible to calculate exactly how many people survive overdoses and how many overdoses they experience during their drug-using careers, unlike fatal episodes, which are sadly ‘known knowns’.

24

Various attempts have been made to estimate the ratio of fatal to non-fatal overdoses, dating back to an Australian study in 2003 in the journal Addiction that used self-reported data from heroin users in Sydney and concluded that the ratio varied from one-to-20, up to one fatal to 30 non-fatal overdoses.

A 2019 paper in the International Journal of Drug Policy estimated

that in the USA, a staggering 3.2 million people who inject drugs had experienced at least one overdose in the previous year. A recent (2024) study in the journal Injury Prevention estimated that between 2010 and 2020, there were approximately 15 non-fatal overdoses for each fatal one.

All of the studies suggest that the rate is underestimated, as it tends to be

VOL 26 ISSUE 2 : FEBRUARY 2025

Opinion | COMMENT

based on either self-reports or on those brought to emergency departments.

One estimate from the US is that 22 per cent of overdose cases are released by first responders and not brought to hospital, or else they refused to go.

It is therefore very difficult to determine how many cases may occur in Ireland. Applying a 15-to-one ratio (with all the caveats surrounding it) to the 244 deaths reported in the recent National Drug Related Deaths Index Bulletin involving opioids, this suggests that there could have been 3,660 non-fatal overdoses in 2021 and a staggering 34,635 between 2012 and 2021, the brain health consequences of which need to be assessed urgently.

I make that point because of the Position Statement by the Brain Injury Association of America on nonlethal opioid overdose and acquired brain injury, and the British Columbia Consensus Statement of 2022 on brain injury, mental health and addiction. The former pointed out that the cognitive consequences of hypoxic brain injury included slowed reaction times; impulsive decision-making; impaired working memory, visual motor skills and executive functions; as well as an increased risk of relapse.

The Statement went on to call for increased awareness of the link between overdose and brain injury; the need for earlier diagnosis; specific rehabilitation programmes; and more detailed research into the incidence of the condition. The Canadian statement highlighted the specific brain areas affected by either anoxia or hypoxia and the consequences of that deprivation, likening it to repeated concussion and as a result, the difficulty some individuals would have in developing insight into their dependency and engaging in harmreduction, especially overdose-avoiding behaviours, in the future.

A 2019 report on non-fatal opioid overdoses and associated health outcomes prepared for the US Dept of Health and Human Services stated that

VOL 26 ISSUE 2 : FEBRUARY 2025

while knowledge of acute complications that arise after an opioid overdose is detailed and robust, the corresponding information for chronic complications is alarmingly scarce, given what is already known about hypoxic brain injuries arising from opioid-induced toxicity.

Fentanyl, it noted, increases the risk of acute brain complications, including hypoxia and induced brain hypothermia, partly because the muscle and chest rigidity it causes makes resuscitation and re-oxygenation more difficult. It also pointed out that the risk increases in those experiencing recurrent overdoses.

In that context, a 2017 paper in the International Journal of Drug Policy on factors associated with selfreported overdoses in drug injectors in England, Wales and Northern Ireland is particularly worrying, as it found that one-third of those reporting an overdose in the previous year reported between two and four episodes, and 7.5 per cent of them had five or more overdoses.

A pilot study of cognitive impairment associated with opioid overdose appeared in 2023 in Drug and Alcohol Dependence. In it, 35 individuals who had an overdose in the past year were compared with 43 persons with opioid use disorder who denied ever overdosing.

The overdose group had significantly lower cognition scores, with the extent of the impairment linked to the cumulative number of past overdoses.

A 2021 paper in the International Journal of Drug Policy reviewed what it called a vicious cycle of neuropathological, cognitive and behavioural sequelae of repeated overdoses. It noted data that suggested that non-fatal overdose can lead to neurodegeneration resembling Alzheimer’s disease, resulting in cognitive decline that in turn leads to potentially reduced adherence to safer drug-using behaviours.

These neuropathological changes have been seen in the brains of young people who had died from a heroin overdose, and are consistent with

those reported in animal models of Alzheimer’s disease. Other studies noted increased levels of amyloid beta expression in brain white matter of opioid users compared to control brains.

On a positive note, this same research group in a Neurochemistry International paper in 2021 referred to the significant overlap between toxic brain injury and Alzheimer’s disease, which suggested that research into treatments for the latter may also lead to therapies for the chronic effects of overdose.

The take-away messages from this are: To highlight the need for CPR and rapid oxygenation, as well as naloxone; the need to call an ambulance, even if naloxone has been administered by a family or staff member; and the need to involve neurology at emergency department level to ensure early intervention if cognitive impairment is suspected. Otherwise, we may be faced with the “tip of the iceberg of a looming public health burden from long-term consequences of repeated overdose,” to quote one expert. ●

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.

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COMMENT

| Opinion

Charles Handy remembered Terry Maguire reflects on the life and work of one of his heroes “I truly believe that managing people, instead of leading them, is wrong and has resulted in too many dysfunctional and unhappy workplaces.”

Charles Handy 1932-2024

A

n obituary in The Irish Press in December alerted me to the death of my great hero Charles Handy.

His management books were critical to my personal and professional development from the late 1980s onwards, and they still inspire me.

He was much more than the myriad management gurus selling their wares at that time. He was a management theorist and social philosopher and his impact was significant, if now largely forgotten. And, of course, he was Irish.

I was asked in the 1990s by the Editor of the Chemist and Druggist magazine to write a book version of my weekly management series.

Re-reading this recently, I was struck by the influence Charles had; on me, on my management views and my personal philosophy of life, and hopefully I still retain these. Two areas that profoundly affected me were his views on business strategy and people management.

Business strategy

Charles studied successful businesses and successful people, and his analysis was that successful businesses are only created by people who have a clear and powerful vision.

This was the core to his famous book The Empty Raincoat.

Passion, he was convinced, only truly comes from a strong vision. You work

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hardest when you know why you’re doing it. The vision might involve setting up a new business whose purpose is to deliver a personal vision. But to continue being successful, the vision must be reset every 10 years or so. New visions are needed to keep the company going forward.

A vision won’t just happen; it needs to be purposefully put in place. This involves detailed analysis of the business, those who work in it, and the environment in which it operates.

The process of creating a vision takes considerable time and resources, and this is perhaps why few of us bother, and why most family businesses fail after three generations.

To create the right kind of vision, we need to begin with the ‘Why?’ — the purpose. Purpose for an organisation is vital and is set out in its Mission Statement. These are common accessories nowadays and, when right, can be a powerful determinant of future direction and central to creating the motivation to

move forward. The Mission Statement should address the deep underlying philosophy of why this business exists in the first place; the things beyond profit. Too often, lip service is paid to a poorly written Mission Statement, with resultant dire outcomes.

Defining a personal purpose or business purpose can be difficult.

For the individual, this is the realm of spirituality, the ‘meaning of life’ stuff, finding out what is really important.

And no-one was better positioned to do this than the oil executive whose father was a priest. This was the core of his book Hungry Spirit.

Charles Handy suggested writing your eulogy. Imagine yourself attending your own funeral. Your friends, family, peers and work colleagues are all there paying their last respects; well, you hope they are. You are writing a eulogy that you would like delivered by, say, a family member (not a spouse or partner — they know you too well), a work colleague, a peer or fellow professional and finally, a friend — four in all.

What would you wish each to say?

Each will see you from a very different angle — the different parts that fit together to complete the real you.

It is a powerful exercise if given the attention and seriousness it deserves.

The essence of these four eulogies are the things which motivate you.

Managing people

Good staff are a business's greatest asset; poor staff, its greatest liability.

Charles Handy was convinced that everyone wants to do a good job, something I initially found hard to accept. He reasoned, with passionate conviction, that as long as an individual has the mental and physical

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Opinion | COMMENT

ability and a willingness to undertake the tasks that make up the job, and he or she is provided with proper support and motivation, then a good job will be done.

As managers, we too often fail to appreciate really how complex people are. Emotions and feelings often usurp logic and rationality. A friendly workplace can be turned into a war zone when people, inflamed passions and poor communication get mixed in the right proportions. This is covered comprehensively in his book Understanding Organisations.

Prof Handy’s point is that too much emphasis is placed on management, and too little on motivation. Tragically, many people are in the wrong job. They either entered the wrong job by default — they had nothing else on offer — or they grew to hate their job, as it failed to fulfil their complex personal needs. Perhaps they should have been rejected at the interview stage.

Perhaps the job should have been less stressful, more challenging, and personally fulfilling. Perhaps they should have been motivated rather than censured. It’s too easy to censure staff when things go wrong. It is more challenging, yet much more productive, to praise them for a job well done.

Even in the 1980s, this was a challenging view. At that time, paternalism was the mainstay of managing employees. Staff were viewed as stupid and slothful, needing to be humiliated and threatened into doing their job. Thanks largely to Charles Handy, but others too of course, the paradigm has changed, with more emphasis on a partnership approach where the employee is empowered and facilitated to do their job through motivation.

This new paradigm reflects a wider social change; a more affluent society, more women in the workforce, more legal protection for employees, and less willingness to accept work as

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the raison d’etre for one’s life. This new way of managing staff is not through less management, but different management.

Handy created the concept of the Portfolio Life in his books The Age of Unreason and Beyond Certainty.

Indeed, he lived the Portfolio Life from the time he left his oil industry job. Few of us now have a job for life — my own father could not have imagined anything else. To retain good employees, employers must treat them well, which means more than a fat salary. Sigmund Freud, when asked the secret to happiness, answered simply:

Few of us now have a job for life — my own father could not have imagined anything else “To work and to love.” The need to do some kind of work is human.

Central to this new paradigm is the need for managers to become leaders.

If we act as leaders, we bring staff with us rather than push them from behind. Everyone wants power and control over the job they do. In this way, they can have pride in it.

The Portfolio Life

Born in Clane, Co Kildare, he grew up at St Michael’s vicarage, in the town where his father was the Protestant vicar. It was a spartan life, he recalled: “We lived in the vicarage, in the midst of the fields, a hundred yards from the beautiful country church where my father said his prayers every morning.”

Charles boarded at Bromsgrove School in Worcestershire, England, moving to Oriel College, Oxford, where he graduated in 1956 with a firstclass honours in Classics, History and Philosophy. In 1956, he took a job with

Shell and stayed for nine years in a post in South East Asia.

He married in 1962 and his wife Elizabeth introduced him to the world of theatre, concerts and art galleries.

She went on to become a successful professional photographer as well as her husband’s agent and business manager, and the couple collaborated on a number of books, including The New Alchemists and A Journey through Tea. When his father died in 1976, Handy was greatly impressed with the size of the attendance at the funeral, reflecting the clergyman’s spiritual influence, and he vowed to emulate this. Handy placed a strong emphasis on social ethics and values in a business context. He concentrated on writing and broadcasting and became a regular contributor to Thought for the Day on BBC, a rare lay contributor in those days.

In July 2006, Handy received an honorary Doctor of Laws degree from Trinity College Dublin for his work on business management and organisational behaviour. In 1998, he received an honorary doctorate from Queen’s University Belfast.

Handy’s wife died at the age of 77 when the couple were involved in a car accident in Norfolk in March 2018. The couple are survived by their children, Kate Handy Jones, who is an osteopath, and Scott, an actor and theatre director, and four grandchildren. Other relatives include his two sisters, Margaret, a retired teacher, and Ruth, a leading figure in management studies in Ireland. ●

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.

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COMMENT

| Opinion

You can’t have your cake and eat it

D

Áine Mac Grory wonders whether with all the challenges we face, there will ever be a fairy tale ending for community pharmacy

ecember 25. Tea’s hot, phones down, feet up. Peace — for now. The only hum going on in the background is Walt Disney’s 1959 Sleeping Beauty. I’m not paying it much mind until it comes to Princess Aurora’s birthday party planning.

Fauna — the Green Fairy Godmother — was tasked with making the birthday cake. The cake was rushed. Fauna simply hadn’t left herself enough time to produce an 11-tiered, fully-iced birthday cake with all the trimmings. Rather than admit defeat, she grabs a broomstick to prop it up and carries on adding to the unstable, melting mess.

The cake is collapsing because it hasn’t had time to cool, the icing is oozing out everywhere, no tier spared, and the candles are sliding down the handle of the now-ruined broomstick.

What could have been a simple Victoria sponge has now been reduced to a big pile of slop. The result? No cake for anyone.

I chuckled to myself looking at an oblivious Fauna re-adding the same candles that are sliding off, conveyer beltstyle, to no avail.

Wouldn’t this be an excellent visual aid to explain the current state of community pharmacy right now?

Fauna, in this case, is our Minister for Health (MfH)*, the collapsing cake tiers are the no longer fit-for-purpose community pharmacy schemes, the melted icing is the overflow of administrative tasks, and the candles are place markers for the ongoing medicine shortages. What does that make the broomstick? It makes sense to label that as the ‘Free’ HRT scheme being announced as a last-ditch effort to keep this collapsing cake standing long enough to get some more votes in.

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No amount of icing and candles are going to cover Fauna’s mess, just like no number of false promises and poorly thought-out schemes are going to conceal the chaos that is the current situation in community pharmacy.

In fairness to Fauna though, she was well intended, just slightly naïve.

The same can’t be said for the MfH, who has left this big pile of slop for the community pharmacists to clean up.

It’s January 3rd and I’m selling cough bottles faster than I can get them on the shelf. Healthmails are filling my inbox, one 'ding' at a time.

Pharmavax was under maintenance all morning, so I couldn’t record the vaccinations until now — what an enormous stride we have made there. No longer a need to inform the patient’s GP,

but still the record can’t be updated for payment unless you record the patient’s favourite colour and star sign.

As I begin to enter in the details of the next prescription, I am interrupted by a team member: “There’s a lady out the front who wants to speak to the pharmacist.”

I crane my neck and look out cautiously.

I internally groan when I discover it’s Mrs HRT at the counter, scowling at the IPU notice sent around to all members by way of aiding our explanation to the public — I think a labelled image of Fauna and the cake would work better, if you ask me.

I cringe at the mounting pile of baskets.

It’s 5pm… we close in an hour. Much like Fauna’s cake, I won’t be standing much longer at this rate either.

“I’ve just been charged €20 for my prescription, but this is for HRT… it’s free

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Opinion | COMMENT

now?” she enquires. “YOU are charging me, even though it’s supposed to be free!

YOU can’t charge me anymore!”

That targeted ‘YOU’ gets me every time.

I sigh. Her question is valid. What do I say? As lovely an idea as it was for HRT to be free, it simply was not possible, for several reasons. Reasons that were ignored by the Department. Reasons that needed to be pushed harder by the IPU. Reasons that I now must explain to my patients for the fifth time today. I agreed that it was an awful promise to break, but equally a promise that I did not make.

So, who does she speak to about this? The Department of Health? Well, their stance, as reported by the Irish Independent, is that the community pharmacists are the reason for this colossal failure.

The bottom line is, Stephen Donnelly expected us to foot the bill without complaint in a desperate attempt to squeeze in a few more votes. And the icing on the cake? These products he promised for ‘Free’ are either unavailable or severely limited in supply.

Something else that struck me is the fact that HRT is already covered through general medical services (GMS) for medical card-holders, and for non-GMS patients, these products are included in the €80 monthly cap via the drugs payment scheme (DPS). This ‘Free’ HRT scheme was just a reformat of already existing schemes and simply wasn’t critical.

I believe a far more pressing matter being asked for by the public was getting Ozempic reimbursed on the GMS and DPS scheme. This was a hot topic all year, and something the nation was crying out for.

That would have been a far better use of limited resources, offering quantifiable health benefits for the public.

One could argue that would be unwise due to the ongoing shortages and supply issues with Ozempic at the moment, but the exact same could be said for HRT. They are both prescribed off label, so the licensing argument is a moot point here too.

The ‘voice of community pharmacy’ needs to step up now and start fighting fire with fire.

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Our response to this catastrophe has been timid and overly cautious. It seems that we are whispering, at a time we need to be shouting from the rafters. Our response to the Department’s attempt at making us scapegoats? A very calm, rehearsed and overly polite suggestion that the MfH’s vision for ‘Free’ HRT for women

by January 2025 was “ambitious”. I would not have been quite as polite. This was a display of complete ignorance, an insult to the women of Ireland, and detrimental to the community pharmacy sector.

Pharmacists have been sent longwinded bullet points about an ‘Integrated women’s healthcare scheme’ that doesn’t and won’t exist until, as the IPU

It seems that we are whispering, at a time we need to be shouting from the rafters have emphasised repeatedly in their communications, substantive progress has been made in the pay claim.

There needs to be a national media campaign defending our position and educating the public on the reality of the situation we are in right now. Something that involves and pays for people with the appropriate reach. The likes of Victoria Jones, ‘The Menopause Pharmacist’, and Sheena Mitchell, who both lent their voices to our cause.

Why are we so afraid to say we do expect to be paid adequately for the professional services we provide? We are trying to run a business here, and that involves adequate revenue. No other profession is apologising for expecting this. No-one should be expected to work for free or feel ashamed for even suggesting that we need to make a living.

The community pharmacy sector can no longer be expected to continue absorbing the cost of providing these schemes that simply do not work, in tandem with

the current supply chain and medicine shortage issues we are facing.

So, try explaining all of this to Mrs HRT. I’ve made peace with the idea of getting out of here on time.

I say, “this isn’t right, but me not charging you only serves to damage me, my livelihood and the viability of this business.

My business will fail if I absorb this cost, and if my business fails, the pharmacy will close its doors. If that happens, you lose your local pharmacy. I cannot operate on a loss. It is simply not possible.”

I look her in the eyes, imploring her to see my point of view and to understand I am not the enemy here. It’s confusing, it doesn’t make sense, and we have all been let down. She accepts this reluctantly and leaves disappointed.

I go back to the dispensary — it’s 5:20.

Twenty minutes spent defusing that situation, zero progress made, and a patient left disheartened.

I sigh and chug my cold tea, made fresh four hours ago. The team just look at me with pity and we roll up the sleeves and gear up to tackle the queue.

‘It’s how much?!’ I hear from the dispensary.

The same team member comes back in: “Áine, sorry — someone wants to speak to the pharmacist”.

Here we go again… *I refer to Stephen Donnelly, who at the time of writing this article was still the Minister for Health. ●

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.

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COMMENT

30

| Opinion

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Opinion | COMMENT

Community with a capital ‘C’ Tomás Conefrey writes about how a pharmacy becomes an important part of its community

I

n the Republic of Ireland, we are fortunate with the pharmacy service we have in operation.

My colleagues in industry, hospital and community are all committed to their job and deliver a first-class service. It’s a pity the Government doesn’t recognise this — or maybe it does?

The fact that the service works well means the powers that be think there are no problems. This is far from the truth, as due to underfunding, many pharmacies are running on minimal staff while our workload increases monthly. Product shortages, increased customer expectations, not to mention the administration burden, make for a high-pressure environment and it is no wonder that newly-graduated pharmacists pivot their careers away from community pharmacy.

It doesn’t have to be this way and until change actually comes, someone needs to put in a good word for community pharmacy. Despite the many frustrations, it’s a great job and I have a bit of experience in it, so will accentuate the positives here.

If you work in the same pharmacy for any period of time, you will start to get to know the customers. This I find to be one of the best parts of the job. Sometimes four generations of the same family visit our pharmacy, and I am always looking at funeral notices if I have heard someone has passed away.

The job title is ‘Community Pharmacist’, and there is a pharmacy on every main street in Ireland. Looking at social media, it’s encouraging to see how many sports teams, community events and local

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projects are supported by pharmacies.

I did ‘Movember’ myself a few years ago for the charity AsIAM. Our Facebook and Instagram followers were very supportive of my effort.

We have been involved in providing opioid substitution therapy for about 20 years, and it has been very rewarding. I was initially reluctant to get involved and it was a bit of a learning curve at the start, but

of vitamin b12, and prolia injections.

GP surgeries are out the door busy and even with practice nurses, it can be difficult for patients to get their vaccinations, and b12 shots in particular, in a timely fashion. I have been surprised with the number of b12 queries we have had in a relatively short time. There is definitely a demand for this service out there.

These are just three reasons why

Sometimes four generations of the same family visit our pharmacy, and I am always looking at funeral notices if I have heard someone has passed away I’m glad I did. At the time, a large proportion of our clients were from the local area and the profile has changed slightly, with people who are rough sleepers coming to us. In fact, several of the clients have been with us longer than some of our staff!

In one example, we have three brothers from the same family who attend us every week, and this service is one I’m delighted to be able to offer to our community. The support we get from the HSE is excellent and if any issues arise with clients, everything is dealt with straight away. If a pharmacist is in a position to offer this service, I recommend it. It generates a lot of goodwill in the community and is a great learning opportunity for pharmacists.

We offer services like flu and Covid vaccinations, 24-hour blood pressure monitoring, administration

despite the pressure, community pharmacy has a lot going for it. With a new Government imminent, I hope they will engage with community pharmacy and all it can offer. A new contract and proper funding will encourage pharmacists to stay in the community, and newly-qualified pharmacists who are trained for these services to thrive.

It really will be community pharmacy with a capital ‘C’. ●

I am a Community Pharmacist is Pearse Street, Dublin 2. I have a strong interest in pharmacy training and staff development and just when I think I have figured out the answers, they go and change the questions. Every day is therefore a learning day.

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pharmacist

CPD

CPD MODULE | Vaccination

Vaccination RSV is a respiratory virus that primarily affects vulnerable populations, and pharmacists play a crucial role in vaccination against the virus, as well as other conditions.

On completion of this module, it is expected the reader will have an enhanced understanding of different types of vaccines, indications, and child immunisation schedules. This module also addresses contraindications, adverse effects, and barriers to vaccination.

AUTHOR: Damien O'Brien MPSI

COMPLETE THIS MODULE ONLINE You can check your answers to the T/F and MCQ questions on PharmacistCPD.ie.

Successful completion of this module will earn you 2 CPD points.

I

ntroduction

Vaccination is a cornerstone of public health and disease prevention. It is one of the most impactful public health measures, responsible for significantly reducing the prevalence of numerous infectious diseases worldwide. Diseases that once caused considerable morbidity and mortality have now been nearly eradicated.

Vaccination is defined as the administration of a preparation that enhances an individual’s immunity to a pathogen. The efficacy of vaccinations can vary between conditions. For instance, the measles vaccine has a high level of efficacy, while the influenza vaccine demonstrates seasonally variable efficacy,

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ranging from 40-to-90 per cent.

Respiratory syncytial virus (RSV) is a respiratory virus that primarily affects vulnerable populations such as children, elderly people, and immunocompromised individuals. RSV infection often presents with upper respiratory symptoms but can sometimes involve the lower respiratory tract. Pharmacists, as accessible healthcare professionals, play a crucial role in vaccination efforts and the management of RSV, contributing significantly to improving public health outcomes.

This module provides an overview of how vaccines work, types of vaccines, indications, contraindications, adverse effects and barriers to vaccination, with a specific focus on RSV, including its prevention, treatment, and the pharmacist’s role in addressing associated challenges.1,2

How vaccination works

Vaccination involves the administration of a vaccine — a compound that enhances an individual’s immunity to a particular disease. Vaccines contain a form of the pathogen, which could be a weakened or inactivated form, an inactivated toxin, or a protein from the pathogen’s surface. By introducing this form of the pathogen, the immune system recognises the antigen as foreign, initiating the production of antibodies and memory T-lymphocytes.

This immunological response enables a

more rapid and robust defence if the body encounters the pathogen in the future.

Without vaccination, the first exposure to the pathogen could cause significant harm or even death before the immune system provides a sufficient response.1 Recent advancements in vaccine technology have revolutionised disease prevention strategies. For example, the introduction of mRNA vaccines for Covid-19 in recent years has demonstrated the potential for rapid development against emerging pathogens, including RSV. Additionally, newer vaccine platforms may facilitate multi-disease vaccination, offering greater protection in fewer doses and making mass immunisation efforts more feasible and cost-effective.1,2

Types of vaccines

Vaccines can be classified into several types, including live attenuated vaccines, inactivated vaccines, mRNA vaccines, subunit vaccines, and toxoid vaccines.  Live attenuated vaccines contain a weakened version of the pathogen. They mimic a natural infection and can therefore create strong, long-lasting immunity.

However, live vaccines may not be suitable for severely immunocompromised individuals. An example of a live attenuated vaccine is the mumps, measles, and rubella (MMR) vaccine.3  Inactivated vaccines use the ‘killed’

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Vaccination | CPD MODULE

version of the disease-causing pathogen.

These vaccines are unable to reproduce inside the host and therefore can’t revert to a harmful state or transmit the disease to others. However, they may be less effective at inducing a long-lasting immune response and often require formulation with an adjuvant or multiple doses.

Hepatitis A vaccine and polio vaccine are examples of inactivated vaccines.3  Toxoid vaccines use inactivated toxins produced by the pathogen to create immunity to the toxin rather than the entire pathogen. This type of vaccine often requires booster shots to maintain longerterm immunity. The tetanus vaccine is an example of a toxoid vaccine.3  Subunit vaccines use specific components of the pathogen, such as a protein, sugar or capsid. By targeting only specific pieces of the germ, these vaccines elicit a strong immune response to key components of the pathogen. They also may require booster shots to provide ongoing protection against disease, but are generally safe for most individuals, including those with weakened immune systems and chronic health conditions.

The hepatitis B vaccine, human papillomavirus, pneumococcal vaccine and meningococcal vaccines are all examples of subunit vaccines.3  mRNA vaccines introduce genetic material that encodes a protein, prompting the immune system to produce antibodies.

They pose no risk of causing disease as they do not contain a live pathogen. The Covid-19 vaccine is an example of an mRNA vaccine.3

Indications and childhood immunisation schedule

Vaccinations are indicated for preventing a wide range of bacterial and viral infections and their sequalae.

Vaccination recommendations may vary by region, reflecting differences in disease exposure and prevalence. The current childhood immunisation schedule recommended by the Health Service Executive (HSE) is as follows:4  2 months – 6-in-1 vaccine (diphtheria, haemophilus influenzae type b (Hib),

VOL 26 ISSUE 2 : FEBRUARY 2025

pharmacist

CPD

TRUE/FALSE QUESTIONS Q1. Vaccination has been responsible for the complete eradication of all infectious diseases worldwide.

Q5. Severe allergic reactions, such as anaphylaxis, are common adverse effects of vaccination.

True or false?

True or false?

Q2. Vaccines improve immunity by stimulating the immune system to produce antibodies and memory cells.

Q6. Pregnant women should avoid live attenuated vaccines unless absolutely necessary.

True or false?

True or false?

Q9. RSV is a single strand DNA virus that primarily affects adults over 60 years old.

True or false?

Q10. Symptoms of RSV can range from mild upper respiratory tract infections, to severe lower respiratory complications like bronchiolitis.

True or false?

Q3. Inactivated vaccines use a live version of a pathogen.

Q7. The tetanus vaccine is an example of a toxoid vaccine.

True or false?

True or false?

Q11. Nirsevimab is a vaccine used to protect infants from RSV.

True or false?

Q4. Live attenuated vaccines are suitable for all individuals, including those who are severely immunocompromised.

Q8. The 6-in-1 vaccine is administered at 2, 4, 6, and 12 months as part of the HSE childhood immunisation schedule.

Q12. Ribavirin is routinely used in Ireland for the treatment of RSV.

True or false?

True or false?

True or false?

hepatitis B, acellular pertussis, inactivated polio, tetanus), Men B (meningococcal B) recombinant vaccine, PCV (pneumococcal conjugate vaccine), rotavirus vaccine.  4 months – 6-in-1 vaccine, Men B vaccine, rotavirus vaccine.  6 months – 6-in-1 vaccine, PCV.  12 months – MMR vaccine, Men B vaccine, varicella (chickenpox) vaccine.  13 months – 6-in-1 vaccine, PCV, Men C (meningococcal C) conjugate vaccine.  Junior infants – 4-in-1 vaccine (diphtheria, tetanus, pertussis, polio), MMR vaccine.  First year (secondary school) – HPV (human papillomavirus) vaccine, Tdap (low dose diphtheria, tetanus and acellular

pertussis) vaccine, meningococcal A, C, W, Y conjugate vaccine.4 The live attenuated influenza vaccine is recommended for individuals aged two-to-17 years, while the quadrivalent inactivated influenza vaccine is recommended for individuals at risk, including those aged 60 years and older, individuals with chronic health conditions, pregnant women, and healthcare workers.

Pregnant women, starting from 16 weeks, should receive the Tdap vaccine.

Covid-19 vaccination is recommended for individuals aged 6 months and older.

The pneumococcal polysaccharide vaccine is recommended for individuals aged 65 years and older, as well as individuals at risk aged two years and

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pharmacist

CPD

CPD MODULE | Vaccination

older. Additional vaccines, such as tetanus boosters (every 10 years if required), hepatitis vaccines, rabies vaccines, and yellow fever vaccines, may be necessary depending on an individual's occupation or travel plans.1,4

Contraindications

Contraindications to vaccination are rare but can vary between vaccines.

The primary contraindication to any vaccine is a documented allergy to the vaccine or one of its components.

Severely immunocompromised individuals should generally avoid live attenuated vaccines, as these vaccines may pose a risk of causing infection.

Pregnant women are typically advised against receiving live attenuated vaccines unless absolutely necessary, due to the potential risk of transmitting the pathogen to the foetus. Vaccination should also be deferred in individuals experiencing an acute febrile illness, as it may complicate the diagnosis of the underlying condition. Vaccination is recommended once the febrile illness has resolved.1

Adverse effects

All vaccines carry a risk of adverse effects, but these are typically mild and self-limiting. Local effects, including pain, redness and swelling at the site of injection, are very common. Localised muscle soreness may also occur.

Generalised symptoms are also common and are due to the immune response to the vaccine. These symptoms usually resolve within a few days and include fever, fatigue and myalgia.

Irritability in young children is also frequently observed. More serious complications are also possible but are extremely rare. Anaphylaxis may occur in response to a vaccine or one of the components ingredients.

Guillain-Barré Syndrome is a very rare but serious adverse effect that affects the peripheral nervous system, potentially causing muscle weakness and paralysis.1

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Barriers to vaccination

Vaccination is a cornerstone of public health and disease prevention, yet anti-vaccination movements and vaccine hesitancy have contributed to declining vaccination rates in some populations. This decline has resulted in the resurgence of previously wellcontrolled diseases, posing significant risks to public health.

Despite the proven benefits of vaccines, many barriers to vaccination still exist. There is misinformation about the safety and efficacy that contributes to a decline in confidence in vaccines. There are some misconceptions regarding vaccinations, where individuals may perceive themselves as healthy and view vaccination as unnecessary.

Furthermore, individuals may have a fear of experiencing pain or adverse effects from vaccination, or they have had a previous negative experience postvaccination. Finally, limited primary care resources can hinder access to vaccines.

Long waiting times, inconvenient clinic locations and insufficient healthcare infrastructure contribute to reduced vaccination uptake.5 Sustained and strategic efforts are essential to address these challenges and improve vaccination rates. Pharmacists play a vital role in reducing vaccine hesitancy through clear, evidence-based communication.

Providing accurate information about the safety, efficacy and necessity of vaccines is critical to building patient trust and dispelling myths.

Pharmacists are among the most trusted professionals in Ireland and are well-positioned to form trusting relationships with patients. They can address individual concerns systematically, reinforcing the benefits of vaccination with factual evidence.

Furthermore, pharmacists have offered vaccines in community pharmacy since 2011 and therefore have significantly contributed to improving accessibility.

Influenza, shingles, Covid-19 and pneumococcal are among vaccinations

offered in community pharmacies, which has reduced pressure on general practitioners and improved accessibility for patients. 5,6,7

Respiratory syncytial virus RSV is one of the most common respiratory viruses that infect children worldwide and is increasingly an important virus in adults, particularly the elderly. RSV is a single-stranded, negative-strand RNA virus. It is highly contagious, causing outbreaks through community and hospital transmission.

Some infants and patients with weakened immune systems may continue to spread the virus, even after symptoms resolve, for as long as four weeks. After inoculation into the nasopharyngeal mucosa or conjunctival mucosa, RSV quickly spreads into the respiratory tract, targeting ciliated epithelial cells.

There is a lack of long-term immunity after infection, making reinfection possible. RSV primarily affects infants and young children, with approximately 90 per cent of children infected within the first two years of life. Older adults and immunocompromised individuals are also at higher risk due to declining immunity.2

Background

The most common clinical presentation of RSV infection is an upper respiratory tract infection. If limited to the upper respiratory tract, symptoms tend to be milder and include rhinorrhoea, cough, sneezing, mild fever, and myalgia. However, RSV often progresses to bronchiolitis, a lower respiratory tract illness with small airway obstruction. This progression is more common in younger children and those at a higher risk of complications.

Symptoms of bronchiolitis can include wheezing, tachypnoea and prolonged expiration. In some cases, this can further progress to pneumonia, hypoxia, respiratory failure, apnoea, and death.

Infection rates are typically higher during the winter months, similar to other respiratory illnesses.2

VOL 26 ISSUE 2 : FEBRUARY 2025

Dimension : 275 X 395 mm (WXH)

33 PROTECT AGAINST RSV PROTECT AGAINST RSV Over 3 RSV seasons, a single dose of AREXVY Over 3 RSV seasons, a single dose of AREXVY demonstrated sustained efficacy against RSVdemonstrated sustained efficacy against RSVLRTD in adults aged 60 years and older1,21,2 LRTD in adults aged 60 years and older

SEASON 1 OVERALL EFFICACY SEASONIN1 PROTECTING OVERALL EFFICACY AGAINST RSV-LRTD3** IN PROTECTING AGAINST RSV-LRTD3**

% 82.6 82.6%

SEASON 1 EFFICACY IN PROTECTING AGAINST RSV-LRTD PARTICIPANTS WITH AT LEAST 1 SEASON FOR 1 EFFICACY IN PROTECTING AGAINST †3** COMORBIDITY OF INTEREST RSV-LRTD FOR PARTICIPANTS WITH AT LEAST 1

% 94.6 94.6%

COMORBIDITY OF INTEREST†3**

AREXVY has a clinically acceptable AREXVY has a clinically safety profile1 acceptable safety profile1 Learn more at Arexvy.ie

Learn more at Arexvy.ie

Primary Endpoint ² 82.6% (96.95% CI*, 57.9, 94.1) AREXVY (7 cases out of 12,466), placebo (40 cases out of 12,494) Secondary Endpoint ² 94.6% (95% CI, 65.9, 99.9) Primary Endpoint ² 82.6% (96.95% CI*, 57.9, 94.1)out of 4861) AREXVY (1 case out of 4937), placebo (18 cases AREXVY out of (40 cases out of 12,494) **Season(71cases data with 6.712,466), monthsplacebo follow up.

2 Secondary Endpoint 94.6% (95% CI, 65.9, 99.9) Vaccination may not²protect all recipients.

AREXVY (1 case outsyncytial of 4937),virus; placebo (18 cases out of 4861)syncytial virus-associated lower respiratory *RSV=respiratory RSV-LRTD=respiratory **Season 1 dataCI=Confidence with 6.7 months follow up. tract disease Interval 2 † Vaccination may not protect all recipients.

Comorbidities of interest^1: chronic obstructive pulmonary disease (COPD), asthma, any chronic *RSV=respiratory syncytial virus; RSV-LRTD=respiratory syncytial virus-associated respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type lower 2, andrespiratory advanced liver disease or renal CI=Confidence disease (endocrinometabolic). tract Interval †  Comorbidities ofand interest^1: chronic obstructive pulmonary disease (COPD), any vaccine chronic suspension for suspension for injection.

[Respiratory Syncytialasthma, Virus (RSV) Arexvy powder respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced (recombinant, adjuvanted)]. liver or renal (endocrinometabolic).

(Please referdisease to SmPC before prescribing).

1 2,3  antigen 120Virus micrograms.

(1RSV Composition: After one dose (0.5 mL) contains: RSVPreF3 powder andreconstitution, suspension for suspension for injection.

[Respiratory Syncytial (RSV) vaccine Arexvy recombinant glycoprotein (recombinant, adjuvanted)].F stabilised in the pre-fusion conformation = RSVPreF3, 2RSVPreF3 produced in 3 Chinese Hamster Ovary cells by recombinant DNA technology), adjuvanted with AS01E containing: plant (Please refer to SmPC before prescribing).

1 1 extract Quillaja saponaria Molina, fraction (QS-21) 25 micrograms, 3-O-desacyl-4’-monophosphoryl antigen2,3 120 micrograms. (lipid RSV Composition: After reconstitution, one dose21(0.5 mL) contains: RSVPreF3 A (MPL) from SalmonellaFminnesota micrograms. indications: Active2RSVPreF3 immunization for thein recombinant glycoprotein stabilised 25 in the pre-fusionTherapeutic conformation = RSVPreF3, produced 3 prevention of lower respiratory disease caused

by RSV in adults 60 yearswith and AS01 older and in adultsplant 50 Chinese Hamster Ovary cells by tract recombinant DNA technology), adjuvanted containing: E through 59 years of ageMolina, who are at increased risk for disease. The use of this vaccine should belipid in extract Quillaja saponaria fraction 21 (QS-21) 25RSV micrograms, 3-O-desacyl-4’-monophosphoryl official recommendations.

Posology and method of administration: For intramuscular injection A accordance (MPL) fromwith Salmonella minnesota 25 micrograms.

Therapeutic indications: Active immunization for the only, preferably in the deltoid muscle.

Administered as a single dose of 0.5 ml.

Revaccination: need not prevention of lower respiratory tract disease caused by RSV in adults 60 years and older and in adults 50 established.

Contraindications: Hypersensitivity to the substances excipients.

Special through 59 years of age who are at increased risk for active RSV disease.

The or useany of of thisthe vaccine should be in warnings and for use: The name and the batch number of the administered product should be accordance withprecautions official recommendations.

Posology and method of administration: For intramuscular injection clearly recorded. Appropriate medical treatment and supervision should be readily available in case of an only, preferably in the deltoid muscle. Administered as a single dose of 0.5 ml. Revaccination: need not anaphylactic event. Vaccination should be postponed in subjects suffering from an acute severe febrile established. Contraindications: Hypersensitivity to the active substances or any of the excipients. Special illness. However, the presence of a minor infection, such as a cold, should not result in deferral. A protective warnings and precautions for use: The name and the batch number of the administered product should be immune response may not be elicited in all vaccinees. Anxiety-related reactions, including vasovagal reactions clearly recorded. Appropriate medical treatment and supervision should be readily available in case of an (syncope), hyperventilation or stress-related reactions may occur. Precautions should be in place to avoid anaphylactic event. Vaccination should be postponed in subjects suffering from an acute severe febrile injury from fainting. Never administer intravascularly or intradermally; no data available on subcutaneous illness. However, the presence of a minor infection, such as a cold, should not result in deferral. A protective administration. Caution in individuals with thrombocytopenia or any coagulation disorder since bleeding may immune responseintramuscular may not be elicited in all vaccinees.

Anxiety-related reactions, vasovagal reactions occur following administration.

Safety and immunogenicity data onincluding Arexvy are not available for (syncope), hyperventilation or stress-related reactions may occur. or Precautions should be intreatment place to avoid immunocompromised individuals.

Patients with immunodeficiency on immunosuppressive may injury fainting.

Neverresponse administer intravascularly or intradermally; noadministered data available on subcutaneous have from a reduced immune to Arexvy.

Interactions: Arexvy may be concomitantly with administration.

Cautioninfluenza in individuals with(standard thrombocytopenia or any coagulation since bleeding may inactivated seasonal vaccines dose unadjuvanted, high dosedisorder unadjuvanted, or standard occur intramuscular Safety and immunogenicity data onvaccine Arexvythe are vaccines not available for dosefollowing adjuvanted).

If Arexvy isadministration. being given at the same time as another injectable should immunocompromised individuals. Patients with immunodeficiency or on immunosuppressive treatment may have a reduced immune response to Arexvy. Interactions: Arexvy may be administered concomitantly with inactivated seasonal influenza vaccines (standard dose unadjuvanted, high dose unadjuvanted, or standard dose adjuvanted). If Arexvy is being given at the same time as another injectable vaccine the vaccines should LOC_IE_Oct 23_PM-IE-RSA-JRNA-230001_275 x 395_D1.indd 1

be administered at different sites. Fertility, pregnancy and lactation: There are no data on the effects on human fertility. Arexvy is not recommended during pregnancy or in breast-feeding/lactating women. Effects on ability to drive and use machines: Arexvy has a minor influence on the ability to drive and use machines. be administered different sites.

Fertility, pregnancy and lactation: There are no the effects Undesirable effects:atVery common (≥1/10): Headache, myalgia, arthralgia, injection sitedata pain,oninjection site on human fertility. is not recommended during pregnancy or in breast-feeding/lactating women.

Effects erythema, fatigue.Arexvy Common (≥1/100 to <1/10): injection site swelling, fever, chills. Uncommon (≥1/1000 ability tolymphadenopathy, drive and use machines: Arexvy has a minornausea, influence on the ability drive and use machines. toon<1/100): hypersensitivity reactions, abdominal pain, to vomiting, injection site Undesirable common (≥1/10): Headache, arthralgia, injection site pain, injection site pruritus, pain,effects: malaise.Very Legal Category: POM A. Marketingmyalgia, Authorisation Number: EU/1/23/1740/001-002. erythema,Authorisation fatigue. Common to <1/10):Biologicals injection site fever, chills. (≥1/1000 Marketing Holder:(≥1/100 GlaxoSmithKline S.A.,swelling, Rue de l’institut 89, Uncommon B-1330 Rixensart, to <1/100): lymphadenopathy, hypersensitivity reactions, nausea, pain, vomiting, Belgium.

Further information is available from GlaxoSmithKline (Ireland)abdominal Ltd. 12 Riverwalk, Citywestinjection Business site Campus, 24. Telephone: 01-4955000.

Code: PI-11947.Authorisation Date of preparation: September 2024. pruritus,Dublin pain, malaise.

Legal Category: POM A. Marketing Number: EU/1/23/1740/001-002.

Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A., Rue de l’institut 89, B-1330 Rixensart, Belgium.

Further is available from (Ireland) Ltd. Authority 12 Riverwalk, Citywest Adverse eventsinformation should be reported directly to GlaxoSmithKline the Health Products Regulatory (HPRA) on theirBusiness Campus, Dublin 24. Telephone: 01-4955000.

Code: PI-11947. preparation: September 2024. website: www.hpra.ie.

Adverse events Date shouldofalso be reported to GlaxoSmithKline on 1800 244 255.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be ▼This medicinal product is subject to additional monitoring. This will allow quick identification of new reported to GlaxoSmithKline on 1800 244 255. safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Please see full Prescribing Information for AREXVY, on Medicines.ie. ▼This medicinal product is subject to additional monitoring. This will allow quick identification of new References: 1. Arexvy SPC, www.medicines.ie (accessed September 2024). 2. Michael G. Ison,et al., on behalf of safety information. Healthcare professionals are asked to report any suspected adverse reactions. the AReSVi-006 study group. The Efficacy of a Single Dose of the Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults ≥60 Years of Age Over 3 RSV Seasons. Poster 3391 presented at CHEST 2024 – (2024 October 6-9), Boston, https://events.rdmobile.com/Lists/Details/2538335 Please United see fullStates.

Prescribing Information for AREXVY, on Medicines.ie. 3. Papi A, Ison MG, Langley JM, et al., for the AReSVi-006 syncytial virus prefusion F protein vaccine in older Engl Med. of References: 1. Study ArexvyGroup.

SPC, Respiratory www.medicines.ie (accessed September 2024).

2. Michael G.adults.

Ison,etNal., onJ behalf 2023;388(7):595-608. doi:10.1056/ the AReSVi-006 study group. TheNEJMoa2209604.

Efficacy of a Single Dose of the Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults ≥60 Years of Age Over 3 RSV Seasons. Poster 3391 presented at CHEST 2024 – (2024 October 6-9), Boston, United States. https://events.rdmobile.com/Lists/Details/2538335 3. Papi A, Ison MG, Langley JM, et al., for the AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med. 2023;388(7):595-608. doi:10.1056/ NEJMoa2209604.

©2024 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

PM-IE-RSA-JRNA-230001 September 2024

©2024 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

PM-IE-RSA-JRNA-230001 September 2024 10/23/2024 8:02:26 PM

pharmacist

CPD

CPD MODULE | Vaccination

Children at higher risk of developing lower respiratory tract disease include those under one year old, premature infants, and children with a history of cardiac, pulmonary, or neuromuscular diseases. At-risk groups also include individuals aged 60 years or older, those who are moderately or severely immunocompromised, and patients with chronic obstructive pulmonary disease, congestive heart failure, hematologic disorders, chronic kidney disease, medical frailty, or residency in a long-term care facility. 2,8 Most individuals, including those hospitalised, tend to recover fully without sequelae. The majority have a good prognosis and are discharged within days. Evidence has shown no link between RSV and the development of wheezing or asthma later in life.

High-risk infants tend to have longer hospitalisations, higher rates of mechanical ventilation, and higher rates of admission to intensive care. The overall mortality rate for RSV is low, with infants with comorbidities tending to have the highest mortality.2

Diagnosis

The diagnosis of RSV and bronchiolitis is typically clinical and does not usually require confirmatory testing or imaging. Specific testing is generally not recommended unless confirmation of diagnosis would alter medical decisionmaking. However, specific testing may be useful to differentiate RSV from other conditions, with rapid antigen testing and polymerase chain reaction (PCR) testing being the main options.

The sensitivity of antigen testing is approximately 80 per cent. PCR testing has a higher sensitivity rate than antigen testing, but may be more expensive and require specialised equipment. X-rays may help diagnose RSV but may still make it difficult to distinguish RSV from bacterial pneumonia. Differential diagnosis may be required to rule out conditions such as asthma, influenza, croup, bronchitis, and pneumonia.2

36

Prevention

Similar to other respiratory viruses, RSV should be managed by an interprofessional team that prioritises prevention. Handhygiene measures are among the most important methods to prevent the spread of RSV. Additionally, patients with respiratory symptoms should cover their mouth and nose with a tissue when coughing or sneezing.

Patients with RSV should avoid attending creche, school or work, and should refrain from sharing cutlery and utensils. Cleaning contaminated surfaces, wearing appropriate personal protective equipment and ensuring proper ventilation in rooms also help limit the spread of RSV.2

Immune prophylaxis

Effective passive immune prophylaxis for RSV is now available for children through monoclonal antibodies. Nirsevimab is a human recombinant monoclonal antibody with activity against RSV. It works by binding to the site at which the virus attaches to a body cell, thereby preventing this binding. This process differs from vaccination, as vaccines stimulate the immune system to produce antibodies, whereas nirsevimab provides the antibodies directly to the child.

It is administered by intramuscular injection into the baby’s thigh. It provides immediate protection, with only one dose needed for the first winter season. In Ireland, all newborn babies born between September 2024 and February 2025 were offered free RSV immunisation with nirsevimab due to the high levels of RSV during the winter season. This injection may be administered in the maternity hospital or at a newborn baby health check.

Nirsevimab has demonstrated proven safety and is more than 80 per cent effective, offering protection for up to 150 days when the risk of severeinfection is high. Adverse effects are typically mild and may include redness at the injection site, fever and rash. Nirsevimab reduces the risk of contracting RSV, decreases hospitalisations, and lowers the risk of complications.2,9

Vaccination

The first vaccines against RSV were approved by the European Medicines Agency (EMA) in 2023. These vaccines stimulate the production of neutralising antibodies and promote the formation of memory B and T cells. The vaccines are indicated for adults aged 60 and older, with one also indicated for pregnant women at 32-to-36 weeks’ gestation.

This is based on the premise that the transplacental transfer of maternal antibodies provides passive protection to the infant during the first few months of life.

Influenza and Tdap vaccines are both administered to pregnant women for similar purposes. Both vaccines are administered intramuscularly. These vaccines are generally well-tolerated, with pain and inflammation at the site of injection being common adverse effects. Systemic adverse effects may include fever, fatigue, myalgia, headache, and malaise. Severe allergic reactions, including anaphylaxis, are rare but can potentially occur. 8

Treatment

The mainstay of treatment for patients with RSV is supportive care. The majority of cases are self-limiting and do not require medical intervention.

Ribavirin is an antiviral drug used in the treatment of RSV infection in the United States. However, it is not licensed in Ireland or recommended

by European Union guidelines for the routine treatment of RSV. This is due to inconsistent evidence regarding its efficacy, its adverse effect profile, the cost and its complex delivery system.

Treatment may depend on the presentation and severity of disease.

Adequate hydration should be ensured, with nasal suction or lubrication as potential options to provide relief from nasal congestion. Antipyretics, including paracetamol and non-steroidal antiinflammatory drugs, are important for reducing fever while also providing pain relief. Hospitalisation may be required if there are signs of respiratory distress.

VOL 26 ISSUE 2 : FEBRUARY 2025

pharmacist cpd Free, independent CPD for Irish pharmacists by Irish pharmacists

FEATURED MODULE:

Vaccination

Successful completion of this module will earn you 2 CPD points

Scan here or visit www.medilearning.ie/pharmacistcpd

pharmacist

CPD

CPD MODULE | Vaccination

Supplemental oxygen may be indicated for hypoxaemia, with continuous positive airflow pressure (CPAP) or nasal highflow oxygen also being potential options.

Patients with severe symptoms or respiratory failure may require intubation or mechanical ventilation.2

Role of the pharmacist in vaccination and RSV management

Pharmacists play an integral role in vaccination and RSV management.

Regarding vaccination, pharmacists vaccinate many people in the community every year. Community pharmacists vaccinated more than 360,000 individuals during the influenza season of 2022/2023, with other vaccination services also available in pharmacies.

They are ideally placed in the community to improve accessibility for patients. In addition to vaccine administration, pharmacists can engage in community outreach programmes to promote awareness of the importance of vaccination. They can combat vaccine hesitancy by clearly communicating with patients to address misconceptions about vaccine safety. Pharmacists possess evidence-based knowledge, enabling them to communicate effectively with patients, build trusting relationships, and act as reliable sources of health information.7 Pharmacists also play a crucial role in the management of RSV. Pharmacists are ideally positioned to educate patients and caregivers on the risks of RSV, particularly highlighting the vulnerability of infants and the elderly. Pharmacists can counsel on appropriate treatment options to manage symptoms. Furthermore, they can assist in the early identification of severe RSV symptoms requiring immediate medical attention.

These symptoms include:  Difficulty breathing.  Blue lips or tongue.  Inability to stay awake or alert.  Long gaps in breathing.  Breathing much faster than usual.9 In the future, pharmacists could potentially be involved in RSV vaccination

38

MCQs Q1. What is the primary purpose of vaccination? a) To cure disease. b) To improve immunity against pathogens. c) To provide temporary relief from symptoms. d) To eliminate genetic disorders.

Q2. Which of the following vaccines contains a weakened version of the pathogen? a) Toxoid vaccine. b) Inactivated vaccine. c) Live attenuated vaccine. d) mRNA vaccine.

Q3. Which vaccine type provides immunity to the toxins produced by pathogens? a) mRNA vaccine. b) Toxoid vaccine. c) Live attenuated vaccine. d) Inactivated vaccine.

Q4. At what age is the first dose of the 6-in-1 vaccine recommended, according to the HSE immunisation schedule? a) Two months. b) Four months. c) Six months. d) One year.

Q5. What is a common mild adverse effect of vaccination?

programmes to protect vulnerable populations, improve clinical outcomes, and reduce the burden on the healthcare system. Pharmacists can collaborate

a) Guillain-Barré syndrome. b) Anaphylaxis. c) Pain, redness or swelling at the injection site. d) Chronic fatigue syndrome.

Q6. What role does nirsevimab play in RSV prevention? a) It acts as a vaccine stimulating antibody production. b) It provides preformed antibodies to prevent RSV. c) It reduces symptoms postinfection. d) It eliminates the RSV virus completely.

with other healthcare professions to promote the prevention of RSV and provide comprehensive care to patients, contributing to a healthier society. ●

References

at: https://www.hse.ie/eng/

[online] Available at: https://

1. Ginglen JG and Doyle

health/immunisation/pubinfo/

ipu.ie/ipu-review-article/au-

MQ (2023). Immunization.

currentschedule.html.

tumn-winter-2023-24-vaccina-

[online] Nih.gov.

5. Goje O, and Kapoor A (2024).

tion-campaign/.

2. Jain H, Schweitzer JW,

Meeting the challenge of vaccine

8. Awosika AO, and Patel P

and Justice NA (2023). Respi-

hesitancy. Cleveland Clinic

(2024). Respiratory Syncytial

ratory syncytial virus infection

Journal of Medicine, [online] 91

Virus Prefusion F (RSVPreF3)

(RSV). [online] National

(9 suppl 1), pp.S50–S56.

Vaccine. [online] Nih.gov.

Library of Medicine.

6. Ipsos (2023). Ipsos (Ireland)

9. HSE.ie (2024). RSV immuni-

3. Gupta S, and Pellett S (2023).

Veracity Index 2023 – Who do

sation for newborns. [online]

Recent Developments in Vaccine

we trust? [online] Available at:

Available at: https://www2.hse.

Design: From Live Vaccines to

https://www.ipsos.com/en-ie/

ie/conditions/rsv/immunisation/.

Recombinant Toxin Vaccines.

ipsos-ireland-veracity-index-

10. HSE.ie (n.d.). RSV (respi-

Toxins, 15(9), pp.563–563.

2023-who-do-we-trust.

ratory syncytial virus). [online]

4 HSE.ie. (n.d.). Current

7. IPU (2024). Autumn Winter

Available at: https://www2.hse.

Schedule. [online] Available

2023/24 Vaccination Campaign.

ie/conditions/rsv/.

VOL 26 ISSUE 2 : FEBRUARY 2025

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EPISODE 1

EPISODE 2

EPISODE 3

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An interview with Prof Derek O’Keeffe

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An interview with Prof Mary Horgan

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IBD | IN FOCUS

Managing IBD in the pharmacy For the more than 40,000 people suffering with IBD in Ireland, the pharmacist is their most accessible healthcare professional, writes Damien O’Brien MPSI

I

ntroduction

Inflammatory bowel disease (IBD) is a chronic inflammatory condition of the gastrointestinal tract, characterised by immunemediated inflammation and tissue damage. IBD encompasses two distinct diseases, ulcerative colitis (UC) and Crohn’s disease (CD), which are differentiated by their location and the depth of bowel wall involvement. Both conditions have a significant morbidity burden and are incurable; however, many treatment options are available.

It is estimated that more than 40,000 individuals are living with IBD in Ireland. Pharmacists are accessible healthcare professionals and can play a crucial role in the management of this chronic condition. This role involves patient education, counselling on lifestyle modifications, and advising on pharmacological and nonpharmacological treatments.1,2

Aetiology and pathophysiology

The exact aetiology of IBD is unknown. There is a significant genetic component, with a family history of the disease being the most important independent risk factor.

A large number of suspected IBD-

VOL 26 ISSUE 2 : FEBRUARY 2025

41

IN FOCUS | IBD

associated genes have been identified.

Evidence suggests that the disease may arise from an inappropriate immune response to environmental antigens, such as intestinal microbes, drugs or toxins, in genetically susceptible individuals.

CD has a strong correlation with smoking tobacco, while smoking appears to have a protective effect against UC. However, smoking should not be encouraged due to its numerous other health risks.1 The intestinal immune system is critical in the pathophysiology of IBD. Under normal physiological conditions, the intestinal epithelium prevents the entry of bacteria or antigens through sealed intercellular junctions. In IBD, these junctions are defective, either due to failure of the primary barrier function or as a consequence of severe inflammation.

These inflammatory responses exacerbate the damage to the intestinal epithelium, allowing further microbial exposure and perpetuating the cycle of inflammation.1

Overview

CD and UC are the two primary conditions within the umbrella of IBD. While they share some similarities, they differ in many aspects. General symptoms of IBD include abdominal pain, fatigue, fever and weight loss.

UC is the most common form of IBD. It is an inflammatory condition characterised by inflammation confined to the mucosa and submucosa of the colon. The disease typically begins in the rectum and extends proximally in a continuous manner. The onset is generally gradual, with periods of remission and relapse.

The main symptoms of UC include rectal bleeding, passing mucus, urgency to defecate, frequent need to defecate, and tenesmus. Smoking cessation and the use of nonsteroidal anti-inflammatory drugs (NSAIDs) tend to exacerbate UC symptoms. Common complications of UC include severe bleeding, toxic megacolon, and an increased risk of colorectal cancer.1,3 CD is an inflammatory gastrointestinal disease that can affect any part of

42

the digestive system, from the mouth to the anus. While symptoms often occur in the intestine, the mouth, oesophagus, and stomach can also be affected. Inflammation in CD tends to be non-continuous, with healthy patches frequently present between lesions. The manifestation of CD varies depending on the area involved. Initial symptoms may include abdominal pain, diarrhoea, flatulence, and fever, followed by periods of remission.

More severe symptoms may present after repeated flare-ups, and these can include severe right-lower quadrant pain, chronic diarrhoea, and anorectal pain. Malnutrition and weight loss are more common in CD due to intestinal involvement. Stress, whether physical

Stress, whether physical or emotional, is often associated with symptom relapse or emotional, is often associated with symptom relapse. Common complications of CD include strictures, fistulas and abscesses.1,4 Patients with IBD are predisposed to extraintestinal manifestations of the disease, which may appear before the onset of intestinal symptoms.

Extraintestinal involvements in UC are present in 10-to-30 per cent of patients and are mainly associated with the skin, eyes and bones. Commonly observed conditions include episcleritis, scleritis, uveitis, peripheral arthropathies and erythema nodosum. Primary sclerosing cholangitis is a significant hepatic extraintestinal manifestation of UC and is associated with an increased risk of colorectal cancer.

Extraintestinal manifestations of CD primarily arise due to systemic inflammation and may include arthritis, uveitis, ankylosing spondylitis, and renal

disorders. The incidence of gallstones and kidney disease is higher in CD, primarily due to the malabsorption of bile salts and fatty acids. Amyloidosis is a rare and latestage manifestation of the disease.1,3,4

Diagnosis

IBD is diagnosed based on a combination of clinical findings, inflammatory laboratory markers, imaging studies, and endoscopic biopsies. Endoscopic evaluation, using either esophagogastroduodenoscopy or colonoscopy, is essential for diagnosing IBD. A wide range of other evaluations may also be used. Parasitic diseases and tuberculosis should be ruled out in the differential diagnosis. A complete blood count may help to identify anaemia, leukocytosis, and hypalbuminaemia.

Evaluation of erythrocyte sedimentation rates (ESR) and C-reactive protein (CRP) levels can be useful, as they are associated with intestinal inflammation. Faecal calprotectin levels can serve as a noninvasive marker for intestinal inflammation.

Imaging techniques, such as ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), are particularly valuable for assessing intra-abdominal complications. Abdominal x-rays can be used to detect free air, bowel obstruction, or toxic megacolon.

Pharmacological treatment The main objectives of pharmacological treatment are to induce and maintain remission, prevent complications, and improve the patient’s quality of life.

The choice of treatment depends on the disease type, severity, location, extraintestinal manifestations, and patient-specific factors.

There is no pharmacological or surgical cure for IBD. Several pharmacological treatment options are available, including aminosalicylates, corticosteroids, immunomodulators, biologics and Janus kinase (JAK) inhibitors. A stepwise approach is often required for the pharmacological management of IBD, with additional treatments for flare-ups as necessary.1

VOL 26 ISSUE 2 : FEBRUARY 2025

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® AMGEVITA (adalimumab) Prescribing Information AMGEVITA® (adalimumab) Prescribing Information every otherweek week from week 1. Reconsider treatmenttreatment beyond 16 weeks if no16 clinical week.

If insufficient response, 20 mg every week. Dosage: ≥ 40 kg: 20 mg every week. Dosage: treatment if≥new serious infection or s every other from week 1. Reconsider beyond weeksother if no clinical other week.consider If insufficient response, consider 40 kg: Please refer to the Summary of Product Characteristics (SmPC) before prescribing response. Paediatric Plaque Psoriasis: treatment of severe chronic plaque Induction: 80 mg at week 0 then 40 mg at week 2. For a more rapid response: with a history of recurring infections or Please refer to the Summary of Product Characteristics (SmPC) Plaque from Psoriasis: treatment of severe plaque 802; risk mgofatadverse weekevents 0 then 40during mg rapid at week 2. For a more rapid Pharmaceutical Form: Single dose pre-filled syringebefore containsprescribing 20 mg adalimumabresponse. psoriasis inPaediatric children and adolescents 4 years of age with inadequate responsechronic 160 mg at week 0, thenInduction: 80 mg at week higher the useresponse: of concomitant immunosup Pharmaceutical Form: Single dose pre-filled syringe contains 20 mg adalimumab psoriasis in children and adolescents from 4 years of age with inadequate response 160 mg at week 0, then 80 mg at week 2; risk of adverse events higher during rapid in 0.4 mL (50 mg/mL) solution, 20 mg adalimumab in 0.2 mL (100 mg/mL) solution, to or if topical therapy and phototherapies are inappropriate. Dosage: 15 kg to < induction. Maintenance starting at week 4: 40 mg dose every other week. If Consult SmPC for details. Serious in 40 mg adalimumab in 0.8 mL (50 mg/mL) solution, mg adalimumab in 0.4 mLto or insufficient consider 40 mg every week or 80 mg everyat other week.

30ifkg: 20 mg followed 20 mg every other week starting one week after initial in 0.4 mL (50 mg/mL) solution, 20 mg adalimumab in 0.2 mL (10040mg/mL) solution, topical therapybyand phototherapies are inappropriate.

Dosage: 15 kg response, to < induction.

Maintenance starting week 4: 40 mg dose everyhospitalisation other week.orIfdeath, were repo (100 mg/mL) solution, 80 mg adalimumab in 0.8 mL (100 mg/mL) solution, and dose. ≥ 30 kg: 40 mg then 40 mg every other week starting one week after initial Reconsider treatment beyond 12 weeks if no clinical response. Ulcerative colitis: Reactivation and new onset TB, 40 mg adalimumab in 0.8 mL (50 mg/mL) solution, 40 mg adalimumab in 0.4 mL 30 kg: 20 mg followed by 20 mg every other week starting one week after initial insufficient response, consider 40 mg every week or 80 mg every other week. single dose pre-filled pen (SureClick®) contains 40 mg adalimumab in 0.8 mL dose. Reconsider treatment beyond 16 weeks if no clinical response. Safety has treatment of moderately to severely active ulcerative colitis in adult patients with (disseminated). Screen all patients b (100 mg/mL) solution, 80 adalimumab in 0.8 mL (100 mg/mL) and anddose.

30 kg: in40paediatric mg then 40 mg other week starting one week after initial Reconsider beyond 12 weekstherapy if no clinical response. Ulcerative colitis:detailed medical (50 mg mg/mL) solution, 40 mg adalimumab in 0.4 mL (100solution, mg/mL) solution been≥assessed patients with every plaque psoriasis for a mean of 13 months. inadequate response to, intolerance totreatment or contraindication for conventional (latent) TB. Perform ® in 0.8 mL (100 mg/mL) solution. Indications and Dosage: 80 mg adalimumab Hidradenitis suppurativa (HS): treatment active moderate severe HSresponse. (acne including corticosteroids and 6-mercaptopurine (6-MP) azathioprine (AZA). for TB in all patients single dose pre-filled pen (SureClick ) contains 40 mg adalimumab in 0.8 mL dose. of moderately to or severely active ulcerative colitis in adult patients withand results recor Reconsider treatment beyondof16 weeks if notoclinical Safety has treatment please refer to SmPC for full information.

For subcutaneous injection. and Treatmentbeen inversa) in adults and adolescents from 12with years plaque of age with inadequate response Dosage: Induction: 160 mg at week 0response and 80 mg at week 2. Maintenance: 40 mg suspected, therapy consult physician with ap (50 mg/mL) solution, 40 mg adalimumab in 0.4 mL (100 mg/mL) solution assessed in paediatric patients psoriasis for a mean of 13 months. inadequate to, intolerance to or contraindication for conventional should be initiated and supervised by specialist physicians experienced in to conventional systemic HS therapy. Dosage: adult: 160 mg at Day 1, followed by every other week. Corticosteroids may be tapered in accordance with clinical reactivation has occurred on adalimum ® 80 mg adalimumab in 0.8 mL (100 mg/mL) solution.

Indications and Dosage: (HS): with treatment of active moderate to severe HS (acne including (6-MP) or azathioprine conditions for which AMGEVITA is indicated.

Ophthalmologists should consultHidradenitis 80 mg at Daysuppurativa 15. At day 29 continue 40 mg every week or 80 mg every other guidelines.

If insufficient response,corticosteroids consider increasing and to 40 6-mercaptopurine mg every week or AMGEVITA®(AZA). treatment. Other opport with aninformation. appropriate specialist before starting treatment.

GiveTreatment patients a Patientinversa) week. Reintroduction after treatment interruption: 40 years mg everyofweek 80 mginadequate every 80 mgresponse every other week.

Do not continue treatment weeks if0no clinical were observed patients receiving ad please refer to SmPC for full For subcutaneous injection. in adults and adolescents from 12 ageorwith Dosage: Induction: 160beyond mg at8 week and 80 mg at week 2. Maintenance: 40inmg Reminder Card. After training in injection technique, patients may self-inject withto conventional other week. Dosage: adolescent (≥therapy.

30 kg): 80Dosage: mg at weekadult: 0 then 40 mg mg everyat other response.

Paediatric ulcerative colitis:week. treatment of moderately to severely active signswith and symptoms of such infectio should be initiated and supervised by specialist physicians experienced in systemic HS 160 Day 1, followed by every other Corticosteroids may be tapered in accordance clinical medical follow-up as necessary. Optimise other concomitant therapies (e.g. week starting at week 1. If response is inadequate, consider increasing to 40 mg ulcerative colitis in paediatric patients from 6 years of age with an inadequate expertise for diagnosis and administra ® conditions for which AMGEVITA is indicated.

Ophthalmologists should consult 80 mg at Day 15.

At day 29 continue with 40 mg every week or 80 mg every other guidelines.

If insufficient response, consider increasing to 40 mg every week or corticosteroids and or/immunomodulatory agents). Rheumatoid arthritis (RA): In every week or 80 mg every other week. Dosage: adult and adolescent: Antibiotics response to conventional therapy including corticosteroids and/or 6-MP or AZA, B reactivation: Reactivation of HBV h combination with methotrexate (MTX) for: 1. moderate to severe,aactive RA in adultweek. with an appropriate specialist before starting treatment.

Give patients Patient mayReintroduction be continued if necessary.

Use concomitant topical antiseptic on aweek daily or or80 who areevery intolerant 80 to ormg have medical contraindications for continue such therapies. were if fatal. patients for HBV infec after treatment interruption: 40 mgwash every mg every other week. Do not treatment beyond 8 weeks noTest clinical patientsin with inadequate response topatients disease-modifying anti-rheumatic basis.

Reconsider treatment beyond (≥ 12 30 weeks Dosage: kg: Induction: 80 mg at week 0 and ulcerative 40 mg at weekcolitis: 2. Maintenance consult a specialist physician Reminder Card. After training injection technique, may self-inject withdrugsother week.

Dosage: adolescent kg):if no 80improvement. mg at weekPeriodically 0 then 40 mg every< 40 other response.

Paediatric treatment of moderately toshould severely active (DMARDs) including MTX; 2. Severe, active and progressive RA not previously evaluate the benefit and risk of continued treatment. Crohn’s disease: treatment starting at week 4: 40mg EOW. Dosage: ≥ 40 kg: Induction: 160 mg week 0 and HBV infection throughout therapy a medical follow-up as necessary.

Optimise other concomitant therapies (e.g. starting to atseverely week active 1. If response is inadequate, increasing 40 2.mg ulcerative paediatric patients from 6 years of age withreactivation an inadequate treated with MTX. Can be given as monotherapy if intolerance to or when continuedweek of moderately Crohn’s disease in adults with noconsider response despite 80 mgto week Maintenance startingcolitis at weekin 4: 80mg every other week. Patients occurs, stop treatment an corticosteroids and or/immunomodulatory agents). Rheumatoid arthritis In ofevery week 80 mg every week.with Dosage: adult andand/or adolescent: Antibiotics response to conventional therapy including 6-MP Neurological or AZA, events: Cautio treatment with MTX is inappropriate.

AMGEVITA® reduces rate of(RA): progression a full andoradequate courseother of therapy a corticosteroid an reaching 18 years should continue their prescribed maintenance dose.

Reconsidercorticosteroids and/or treatment. joint damage whenfor: given combination MTX. active Dosage:RA 40 mg every othermayimmunosuppressant intolerance to or have medical contraindications for such wash treatment if noare clinical response.toNoorrelevant in children centraltherapies. or peripheral nervous sys combination with methotrexate (MTX) 1.inmoderate towith severe, in adult be continued if or necessary.

Use concomitant topical antiseptic on abeyond daily 8 weeks or who intolerant have use medical contraindications for such week as a single dose via subcutaneous injection. Continue MTX. Glucocorticoids, therapies. Dosage: Induction: 80 mg at week 0, then 40 mg at week 2. For a more <6 years. Uveitis: treatment of non-infectious intermediate, posterior and panuveitis discontinuation if any of these develo patients with inadequate response to disease-modifying anti-rheumatic 12atweeks if no improvement.

Dosage: < 40tokg: Induction:in80patients mg atinweek 0 and 40 mg at week with 2. Maintenance salicylates, non-steroidal anti-inflammatory drugs, or analgesics candrugs be continuedbasis. rapidReconsider response: 160 treatment mg at week 0,beyond then 80 mg week 2; risk of adverse events inPeriodically adults with inadequate response corticosteroids, need of non-infectious intermediate uveiti (DMARDs) including MTX; Severe,Inactive and progressive RA not previously benefit and riskMaintenance: of continued Crohn’ disease: treatment starting at week 4: 40mg EOW. isDosage: ≥ 40 kg: Induction: 160 during mg week 0 and during2.treatment. monotherapy, patients may require 40 mg every week or 80evaluate corticosteroid-sparing, or in whom corticosteroid treatment inappropriate. higher the during rapid induction.

40 treatment. mg dose every other sweek. treatment.

Allergic reactions: R everyas other week if there ifisintolerance a decrease into clinical response.

Reconsiderof moderately Corticosteroids be tapered in accordance clinicalin guidelines.

If decrease Dosage:despite 80 mg at week80 0 and mg every week from week 1. Thereat is week limited 4: 80mg every otheranaphylaxis.

For serious allergic or treated with MTX. Can bemggiven monotherapy or when continued tomay severely active Crohn’swith disease adults with no response mg40week 2. other Maintenance starting week. Patients treatment beyond 12 weeks if no in clinical response, can increase to 40 mg every week or 80 mg every other week. experience in initiation of treatment with adalimumab alone. Treatment can be immediately and initiate appropriate th ® clinical response. Consider need for dose treatment with MTX is inappropriate.

AMGEVITA reduces rate of progression of a full and adequate course of therapy with a corticosteroid and/or an reaching 18 years should continue their prescribed maintenance dose.

Reconsider interruption, e.g. before surgery or if serious infection occurs. Polyarticular juvenile If no response by week 4 there may be benefit from continued therapy to week 12. initiated in combination with corticosteroids and/or with other non-biologic disorders: A possible risk of maligna joint damage when given in combination with MTX. Dosage: 40for mgactive every or intolerance toclinical or have medical contraindications for such agents. treatment beyond 8 weeksmay if no clinical response. No relevantleukaemia, use in children idiopathic arthritis (pJIA): In combination with MTX pJIAother in patientsimmunosuppressant Reconsider treatment beyond 12 weeks if no response.

Paediatric CD, ≥ 6 immunomodulatory Concomitant corticosteroids be tapered starting cannot be excluded (see S ® from the age of 2 years with inadequate response to one or more DMARDs. Cantherapies. years: Moderately severely active80 CDmg withat inadequate intolerance weeks after initiating treatment with AMGEVITA . Evaluate on a yearly basisintermediate, posterior with a medical history of extensive week as a single dose via subcutaneous injection.

Continue MTX. Glucocorticoids, Dosage:to Induction: week 0,response then 40to,mg at week two 2. For a more <6 years.

Uveitis: treatment of non-infectious and panuveitis given as monotherapy ifdrugs, intolerance to or when continued treatment with MTXrapid to or contraindication to conventional therapy including primary nutrition therapy the benefit and risk of continued treatment.

Paediatricresponse uveitis: treatment of patients with a history salicylates, non-steroidalbe anti-inflammatory or analgesics can be continued response: 160 mg at week 0, then 80 mg at week 2; risk of adverse events in adults with inadequate to corticosteroids, in patients in need of of PUVA treatm is inappropriate. Dosage: 10 kg to < 30 kg: 20 mg every other week. ≥ 30 kg: and a corticosteroid and/or an immunomodulator. Dosage: < 40 kg: Induction: 40 paediatric chronic non-infectious anterior uveitis in patients from 2 years of age and during treatment. Melanoma a during treatment. In monotherapy, patients may require 40 mg every corticosteroid-sparing, or toinconventional whom corticosteroid treatment isreported. inappropriate. rapid induction.

Maintenance: 40 mg dose every other 40 mg every other week. Reconsider treatment beyond 12 week weeks iforno80 clinicalhigher mg atduring week 0 then 20 mg at week 2. For a more rapid response: 80 mg at week 0 who Caution in COPD patient haveweek. had an inadequate response to or are intolerant therapy, Enthesitis-related (ERA):response. treatment of active ERA in patientsCorticosteroids then 40 mg at week of adverse events higher with duringclinical rapid induction. or in conventional therapy 80 is inappropriate.

30mg kg: 40 mg every to heavy smoking. Con mg every other week ifresponse. there is a decreasearthritis in clinical Reconsider may 2;berisk tapered in accordance guidelines.

If whom decrease Dosage: mg at weekDosage: 0 and≥40 every other week from week 1.malignancy There is due limited ® 6 years and older with inadequate response to, or intolerance to conventional Maintenance starting at week 4: 20 mg dose EOW. response, week in combination with MTX. in A loading dose of mg (< 30 kg)with or 80 adalimumab mg of AZA or 6-MP treatment beyond 12 weeks if no clinical response.

Consider need for dose in clinical response, can increase to 40 mgIf insufficient every week or 80consider mg everyother other week. experience initiation of40treatment alone. Treatment canand beAMGEVITA (hep therapy. Dosage: 15 kg to < 30 kg: 20 mg every other week. ≥ 30 kg: 40 mg every 20 mg every week. Dosage: ≥ 40 kg: Induction: 80 mg at week 0 then 40 mg at (≥ 30 kg) may be administered 1 week in advance of maintenance therapy. No Caution in patients with a history of m interruption, e.g. before surgery orAnkylosing if seriousspondylitis infection(AS): occurs.

Polyarticular juvenile response by week 4 there may beatbenefit from to week 12. corticosteroids and/or with other non-biologic other week. treatment of adults with severe activeIf no week 2. For a more rapid response: 160 mg week 0, then 80 continued mg at week 2;therapy risk clinical data on use ofinitiated loading doseinin combination patients < 6 years.with Evaluate benefit and risk colon cancer unknown. Screen patie AS with response conventional therapy.

Axialinspondyloarthritis of adverse treatment events higherbeyond during rapid at weekPaediatric 4: of continued on a yearly basis. Contraindications: Hypersensitivity to carcinoma,starting for dysplasia before and idiopathic arthritis (pJIA): In inadequate combination withtoMTX for active pJIA patients Reconsider 12induction. weeks ifMaintenance no clinicalstarting response.

CD, treatment ≥ 6 immunomodulatory agents. Concomitant corticosteroids may be tapered radiographic response evidence of to AS:one treatment of adults with severe 40 mg dose EOW. Ifto insufficient mg every weekresponse or 80 mg to, theintolerance active substance or to any excipients; tuberculosis (TB) or other Adverse events of the haematologi from the age of 2 yearswithout with inadequate or more DMARDs. Can axialyears: Moderately severelyresponse, active consider CD with40inadequate two weeks afterActive initiating treatment withsevere AMGEVITA®. Evaluate on a yearly basis spondyloarthritis without radiographic evidence of AS but with objective signs of EOW. Reconsider treatment beyond 12 weeks if no clinical response. Paediatric infections such as sepsis and opportunistic infections; Moderate to severe heart cytopenia, have been reported. Advise be given as monotherapy if intolerance to or CRP when continued with MTX to, orto orCrohn’ contraindication to conventional including therapy the Warnings benefitand and risk of continued treatment. treatment of of blood dysc inflammation by elevated and/or MRI, and treatment an inadequate response s disease: treatment of moderately to therapy severely active Crohn’sprimary disease innutrition failure (NYHA class III/IV).

Precautions: Traceability: Clearly record Paediatric uveitis: if signs and symptoms is inappropriate. Dosage: 10 kg to < 30 kg: 20 mg every other week. ≥ 30 kg: and a corticosteroid and/or an immunomodulator.

Dosage: < 40 kg: Induction: 40 paediatric chronic non-infectious anterior uveitis in patients fromreceive 2 years of age intolerance to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis (PsA): paediatric patients from 6 years of age with inadequate response to conventional the name and batch number.

Infections: Patients taking TNF-antagonists are more concurrent vaccinations, exce treatment of active treatment and progressive psoriatic12 arthritis in adults inadequatemg therapy including a corticosteroid and/or an80 mg susceptible to serious infections, impaired lungresponse function. Monitor up to date therapy, with all immunisations pri 40 mg every other week.

Reconsider beyond weeks if nowith clinical at week 0 thenprimary 20 mgnutrition at weektherapy 2. Forand a more rapid response: at week 0 who haveespecially had an ifinadequate to orforare intolerant to conventional response to previous DMARD therapy. Dosage: (AS, nr-axSpA, PsA): 40 mg every immunomodulator, or intolerant to or have contraindications for such therapies. infections, before, during and for 4 months after treatment. Do not initiate treatment failure: See contraindications. Caut response. Enthesitis-related arthritis (ERA): treatment of12 active patients 40 mg 2; risk during induction. or inuntil whom conventional therapyrisk/benefit is inappropriate.

Dosage: ≥ 30 kg: 40 mgtreatment every if new or worse other week.

Reconsider treatment beyond weeksERA if noin clinical response.then Dosage: < 40atkg:week Induction: 40 mgofat adverse week 0 thenevents 20 mg athigher week 2. For a morerapid during an active infection, infection is controlled. Consider prior Discontinue 6 years and older with Psoriasis: inadequate response to, toorsevere intolerance to conventional starting week04: 2040mg EOW. If insufficient response, consider other week inorcombination with MTX.ofAhigh loading 30 kg) or 80 mg treatment of moderate chronic plaque psoriasis in adults woMaintenance to treatment in patients exposed to TB who have travelled in areas risk dose of 40 mg (< Autoimmune rapid response: 80 mg at at week then mgdose at week 2; risk of adverse events processes: Autoimmu for systemic therapy.

Dosage: 80≥mg week40 0, followed by 40 mg20 mg higher duringweek. rapid induction.

Maintenance at week80 4: 20 mgat dose every0 then of TB40 or endemic new and monitor closely.inStop development of aNo lupus-like syndrom therapy. Dosage: 15 kg are to <candidates 30 kg: 20 mg every other week.

30at kg: mg every every Dosage: ≥ 40 kg:starting Induction: mg week mg at mycoses. (≥ 30 Evaluate kg) may beinfections administered 1 week advance of maintenance therapy. other week. Ankylosing spondylitis (AS): treatment of adults with severe active week 2. For a more rapid response: 160 mg at week 0, then 80 mg at week 2; risk clinical data on use of loading dose in patients < 6 years. Evaluate benefit and risk AS with inadequate response to conventional therapy. Axial spondyloarthritis of adverse events higher during rapid induction. Maintenance starting at week 4: of continued treatment on a yearly basis. Contraindications: Hypersensitivity to without radiographic evidence of AS: treatment of adults with severe axial 40 mg dose EOW. If insufficient response, consider 40 mg every week or 80 mg the active substance or to any excipients; Active tuberculosis (TB) or other severe spondyloarthritis without radiographic evidence of AS but with objective signs of EOW. Reconsider treatment beyond 12 weeks if no clinical response. Paediatric infections such as sepsis and opportunistic infections; Moderate to severe heart All Pagesto, or inflammation by AMG1003_Amgevita_DPS_Advert_JUL24_04.indd elevated CRP and/or MRI, and an inadequate response Crohn’s disease: treatment of moderately to severely active Crohn’s disease in failure (NYHA class III/IV). Warnings and Precautions: Traceability: Clearly record intolerance to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis (PsA): paediatric patients from 6 years of age with inadequate response to conventional the name and batch number. Infections: Patients taking TNF-antagonists are more

WHAT’S BEHIND AMGEVITA® (ADALIMUMAB) MAKES THEBEHIND DIFFERENCE WHAT’S AMGEVITA® ® (ADALIMUMAB) WHAT’S BEHIND AMGEVITA YOU CAN PRESCRIBE AMGEVITA® MAKES THE DIFFERENCE (ADALIMUMAB) WITH CONFIDENCE: MAKES THE DIFFERENCE YOU CAN PRESCRIBE AMGEVITA® TrackWITH record CONFIDENCE:

AMGEVITA® is backed by nearly four decades YOU CAN PRESCRIBE AMGEVITA® of experienceTrack in biologics, record quality Irish manufacturing WITH CONFIDENCE: and a history of reliable product supply.1

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AMGEVITA® is backed by nearly four decades of experience in biologics, quality Irish manufacturing Track record and a history of reliable product supply.1 upply relia 1 ce s bili AMGEVITA® is backed by nearly four decades llen 1 of experience in biologics, quality Irish manufacturing Tried andproduct tested and asafety, history of reliable supply.1 Similar efficacy and immunogenicity to the supply relia bili Similar safety, efficacy and immunogenicity to theence # l originator proven in multiple trials of AMGEVITA® l Y originator proven in multiple trials# of AMGEVITA® 1 EARS 2,3 in over 800 patients.

BIOLOG intest over ed 800 patients. 2,3 Tried and ICS EXE PEX RP IEE NR Similar safety, efficacy and immunogenicity to the IENCE CE YEARS originator proven in multiple trials# of AMGEVITA® BIOLOG in over 800 Patient patients. 2,3friendly IC AMGEVITA® is citrate-free, latex-free with patientEXPERIENC S E 4,5 SureClick®latex-free pre-filled device.

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r week. If insufficient response, consider 20 mg every week. Dosage: ≥ 40 kg: treatment if new serious infection or sepsis and treat. Exercise caution in patients stranded DNA. Surgery: Consider the long half-life of AMGEVITA® for planned pancytopenia, aplastic anaemia, central and peripheral demyelinating events and ction: 80 mg at week 0 then 40 mg at week 2. For a more rapid response: with a history of recurring infections or who are predisposed to infections, including surgical procedures. Monitor closely for infections. There is limited safety reports of lupus, lupus-related conditions and Stevens-Johnson syndrome. mg at week 0, then 80 mg at week 2; risk of adverse events higher during rapid the use of concomitant immunosuppressive medications. Serious Infections: experience in patients undergoing arthroplasty or surgical procedures. Elderly Pharmaceutical Precautions: Store in a refrigerator (2°C – 8°C). Do not freeze. ction. Maintenance starting at week 4: 40 mg dose every other week. If Consult SmPC for details. Serious infections, including those associated with patients: Serious infections were higher in patients over 65, some of which were Keep the prefilled syringe or pre-filled pen in the outer carton in order to protect fficient response, consider 40 mg every week or 80 mg every other week. hospitalisation or death, were reported in patients receiving treatment. TB: fatal. Consider risk of infections in these patients. Interactions: Antibody formation from light. The prefilled syringe or pre-filled pen may be stored up to a maximum Reactivation and new onset TB, both pulmonary and extra-pulmonary was lower when AMGEVITA® was given together with MTX rather than as of 25C for up to 14 days. The pre-filled syringe or pre-filled pen must be protected nsider treatment beyond 12 weeks if no clinical response. Ulcerative colitis: ment of moderately to severely active ulcerative colitis in adult patients with (disseminated). Screen all patients before therapy initiation for active or inactive monotherapy. Combination of AMGEVITA® with other biologic DMARDs (e.g. from light and discarded if not used within the 14-day period. Legal Category: POM. equate response to, intolerance to or contraindication for conventional therapy (latent) TB. Perform detailed medical assessment and appropriate screening tests anakinra and abatacept) or other TNF-antagonists is not recommended. Fertility, Presentation and Marketing Authorisation Number: AMGEVITA® 20 mg solution pregnancy if clearly®needed. Women of for injection in pre-filled syringe: EU/1/16/1164/001 – 1 pack, AMGEVITA® 40 mg ding corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA). for TB in all patients and results recorded on patient reminder card. If latent TB is pregnancy and lactation Only use during ® der 20 mg every week.

Dosage: ≥ 40 kg: treatment if new serious infection or sepsis andconsult treat.

Exercise caution in stranded DNA.prophylaxis, Surgery: Consider theConsider long half-life of AMGEVITA for planned pancytopenia, aplastic anaemia, centralfor and peripheral demyelinating and and – ® 40 kg: treatment if new serious infection or sepsis and treat.

Exercise caution inpatients patients stranded DNA. Surgery: longusehalf-life ofcontraception AMGEVITA forand planned pancytopenia, aplastic anaemia, central peripheral demyelinating events and ge: Induction: 160 mg at week 0 and 80 mg at week 2. Maintenance: 40 mg suspected, physician with appropriate expertise Despite TB childbearing age tothe consider of adequate during for at least solution injection in pre-filled syringe: events EU/1/16/1164/003 2 pack AMGEVITA at week 2.

For a more rapid response: with a history of recurring infections or who are predisposed tooninfections, including surgical procedures.

Monitor closely forafter infections.

There is limited safety ofreports of lupus, lupus-related and syndrome. y other week. Corticosteroids may be tapered clinical infections or who are reactivation has occurred adalimumab.

If active TB issurgical diagnosed, do not initiate 5 Monitor months the last treatment.

Administration liveisvaccines (e.g.

BCG) to reports 40 conditions mg solution forStevens-Johnson injection in pre-filled pen: EU/1/16/1164/007 – 2 pack; ponse: within aaccordance history ofwith recurring predisposed to infections, including procedures. closely forprocedures. infections.

There limited safety of lupus, lupus-related conditions and Stevens-Johnson syndrome. sk of adverse events higher during rapid the use of concomitant immunosuppressive experience in patients undergoing arthroplasty or surgical Elderly Pharmaceutical Precautions: in a refrigerator (2°C – 8°C).

Do not ®medications. Serious Infections: ® ® AMGEVITA elines. If insufficient response, consider increasing to 40 mg every week or AMGEVITA treatment. Other opportunistic infections: Opportunistic infections infants exposed to AMGEVITA in utero is not recommended for 5 months following Store 20 mg/0.2ml solution forfreeze. injection in pre-filled syringe: gkg 4:rapid the use of concomitant immunosuppressive medications.

Serious Infections: experience in patients undergoing arthroplasty or surgical procedures.

Elderly Pharmaceutical Precautions: Store in a refrigerator (2°C – 8°C).

Do not freeze.

40 other mg dose every other week.treatment If Consult infections, those associated with Stop patients: Serious infections werethe higher in patients over 65, during some of which were Keep the prefilled syringe pen in the outer carton in order to ® ® ® protect every week.

Do not continue beyond 8 weeks if no clinicalSmPC for details. Seriouswere observedincluding in patients receiving adalimumab.

AMGEVITA in patients with mother’s last injection pregnancy.

AMGEVITA can be used duringor pre-filled EU/1/16/1164/010 – 1 pack, AMGEVITA 40 mg/0.4ml solution for injection in ® were very mg every colitis: other week. hospitalisation or death,infections, were reported in symptoms patientsthose receiving treatment.

TB: fatal.

Considerwith risk of infections inbreastfeeding. these patients.

Interactions: Antibody from light. prefilled syringeKeep or pre-filled pen EU/1/16/1164/012 may besyringe stored upor to maximum eek.week If or 80 ulcerative SmPC for details. Serious withwith patients: Serious infections wereEffects higher in patients over some of The which the prefilled pen ®in40the outersolution carton in order to protect onse.

Paediatric treatmentConsult of moderately to severely active signs including and of suchassociated infections.

Consult physician appropriate on ability to driveformation and use65, machines: AMGEVITA may have pre-filled syringe: – a2pre-filled pack, AMGEVITA mg/0.4ml ® ® Reactivation and new onset TB, both for pulmonary and extra-pulmonary no clinical response.

Ulcerative colitis: was lower when AMGEVITA was given together with MTX to rather than as machines. of 25C for up to 14 days.

The pre-filled syringe or pre-filled pen must be protected ative colitis in paediatric patients from 6 years of age with an inadequate expertise diagnosis and administration of empiric antifungal therapy.

Hepatitis a minor influence on the ability drive and use Vertigo and visual for injection in pre-filled pen: EU/1/16/1164/015 – 2 pack, AMGEVITA 80 mg/0.8ml week. hospitalisation or death, were reported in patients receiving treatment.

TB: fatal. Consider risk of infections® with in these patients.

Interactions: Antibody formation from light. 14-day The prefilled syringe orPOM. pre-filled pen may be stored up to a maximum ulcerative colitis in adult patients withcorticosteroids and/or 6-MP(disseminated).

Combination Screen all patientsBbefore therapyReactivation initiation forofactive or inactive otherAdverse biologic DMARDsVery (e.g.common from≥light and discardedtract if not used within the Legalpen: Category: onse to conventional therapy including or AZA, reactivation: HBV has occurred inmonotherapy. chronic carriers; some casesof AMGEVITA impairment ® may occur.

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Date of prep to May 2024 IRL-501-0524-80001

04/09/2024 16:19

IN FOCUS | IBD

Aminosalicylates

Mesalamine and sulfasalazine are aminosalicylates used in the treatment of IBD. The exact mechanism of action of aminosalicylates is unclear, but it is thought that they reduce the inflammatory response through the cyclooxygenase and lipoxygenase pathways, thereby decreasing the synthesis of prostaglandins and leukotrienes.

Sulfasalazine is a prodrug made up of mesalamine and sulfapyridine, which is metabolised by bacteria in the colon into its active components, allowing mesalamine to work locally in the colon. Oral or rectal administration of aminosalicylates can be used as firstline treatment for mild-to-moderate UC, achieving a remission rate of about 50 per cent. Aminosalicylates can be used to both treat and prevent flareups of UC. However, their use in CD is less well-established. They may be beneficial for treating mild colonic CD, but are ineffective in the small intestine.

Aminosalicylates remain a mainstay of treatment for mild-to-moderate disease limited to the rectum. Common adverse effects of aminosalicylates include nausea, vomiting, anorexia, dyspepsia, headache, and skin rash.

Sulfasalazine is associated with reversible male infertility, which resolves after discontinuation of treatment. Lesscommon adverse reactions include leukopenia, thrombocytopenia, and haemolytic anaemia. Renal function should be carefully monitored both before and during treatment.3,4,5,6

Immunomodulators

Immunomodulator agents are effective in treating patients with IBD, with examples including thiopurines and methotrexate.

Immunomodulators are steroid-sparing agents used in the maintenance therapy of mild-to-moderate IBD. They have a slow onset of action, which can take up to 12 weeks, and therefore are not effective in treating flare-ups.

These agents may be used in combination with steroids to reduce inflammation initially. They can also be

46

used in the treatment of moderateto-severe disease in combination with biologics, serving as an adjunct to reduce immunogenicity against biologics. Combination therapy with an immunomodulator and a biologic may be more effective than monotherapy with either medication. Azathioprine works by inhibiting purine synthesis, resulting in decreased DNA and RNA production in white blood cells, thereby causing immunosuppression. It is typically administered orally and requires 6-8 weeks to take effect.

Nausea is the most common adverse effect, which is dose-dependent.

Other common adverse effects include fever, myalgia, fatigue, bone marrow suppression, and rash. Rarer adverse effects include carcinogenesis, pancreatitis and alopecia. 3,4,7,8 Methotrexate is an antifolate drug that causes immunosuppression by inhibiting T-lymphocyte proliferation and activation.

Methotrexate is effective at achieving clinical remission in CD patients, but may not be as effective in UC. It is typically administered once weekly, either orally or via injection (intramuscular, intravenous, intrathecal or subcutaneous).

Folic acid supplementation should be considered to reduce the risk of bone marrow suppression. The most common adverse effects are gastrointestinal issues such as nausea, vomiting, ulceration, and loss of appetite. Methotrexate also has more serious and potentially lifethreatening adverse effects, including teratogenicity, pancreatitis, bone marrow suppression, malignancy, infection, and renal failure. 3,4,7,9

Biologics

Biologic agents are effective in treating moderate-to-severe disease. In recent times, a stepwise approach to the treatment of IBD has been adopted, where biologics are introduced earlier in highrisk patients and patients with severe disease, with de-escalation once a clinical response is achieved.

Biologic agents have the advantages of reduced toxicity, high selectivity, and

high efficacy compared to other diseasemodifying therapeutic options. Antitumour necrosis factor (TNF) therapy and anti-interleukin (IL)-12/23 therapy are the two main categories of biologic agents used to treat IBD. TNF is a proinflammatory cytokine that can cause chronic inflammation and tissue damage when overexpressed. Golimumab, infliximab and adalimumab are three examples of anti-TNF agents licensed for treating IBD. The main adverse effects associated with anti-TNF therapy include an increased risk of infection, congestive heart disease, malignancies, drug-induced lupus, and skin reactions. Anti-TNF agents are effective in corticosteroidresistant or immunomodulator-refractory CD. Their effect is relatively rapid, with benefits being observed within two weeks of initiation. 3,4,10 IL-12 and IL-23 are pro-inflammatory cytokines involved in intestinal inflammation and the pathophysiology of IBD. Ustekinumab is an example of a commonly-used drug that reduces the activity of IL-12 and IL-23, thereby decreasing intestinal inflammation in IBD. It can be effective in patients who have failed prior corticosteroid, immunomodulator or anti-TNF treatments. The most common adverse effects of this treatment option include nasopharyngitis, headache, increased risk of infection, cardiovascular events, and malignancies. 3,4,10 Leukocyte trafficking agents work by selectively inhibiting an adhesion protein (integrin α4β7) on a memory T cell, preventing the T cells from binding to mucosal cells in the intestine. This produces anti-inflammatory effects specific to the intestine and is effective in inducing and maintaining remission in CD. Vedolizumab is an example of an agent in this class used to treat CD. The time to effect is slower than that of anti-TNF therapy, and may take around 10 weeks.

The adverse effect profile is favourable due to the specificity of the drug.4 A Janus kinase (JAK) inhibitor targets enzymes that contribute to abnormal

VOL 26 ISSUE 2 : FEBRUARY 2025

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« 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

IN FOCUS | IBD

immune responses and, therefore, reduces inflammation. Upadacitinib and tofacitinib are two JAK inhibitors used to treat IBD and are administered orally.

They are effective in treating patients who have previously failed conventional and biologic treatment options. The onset of action is rapid, occurring within two weeks. These drugs increase the risk of herpes zoster virus and, therefore, the shingles vaccine is recommended before initiating treatment.4

Corticosteroids

Corticosteroids are a useful therapeutic option if other treatment options have failed or in the case of flare-ups.

Corticosteroids work through multiple pathways, producing anti-inflammatory and immunosuppressive effects. They are very effective in reducing inflammation and inducing remission in IBD. They can be used both orally and rectally.

Corticosteroids are primarily used to induce remission and stabilise the condition until immunomodulator or biologic therapy take effect, particularly in moderate-to-severe disease.

Prolonged corticosteroid use, particularly systemic use as maintenance therapy, is not recommended due to chronic adverse effects such as osteoporosis, adrenal insufficiency, mood changes, blood glucose fluctuations, and venous thromboembolism.

Second-generation corticosteroids, such as budesonide, have a more favourable safety profile than conventional corticosteroids. Targeted delivery of corticosteroids to the site of inflammation is important to reduce systemic adverse effects. 3,4,11

Non-pharmacological treatment There are several non-pharmacological treatment options available, either as monotherapy or in combination with pharmacological treatment. The rate of surgical intervention has decreased since the development of biologics, but it remains an important treatment

48

option. Surgery may be used in cases of refractory disease or when complications such as strictures, intestinal perforation, heavy bleeding or carcinogenesis are present. It may also be indicated if a patient with severe IBD can’t tolerate pharmacological treatment. Colectomy in UC may be curative as the disease is restricted to the colon, while the aim in CD is to manage complications. 3,4 Dietary management and nutritional support may be used as an adjunct to treatment, particularly in CD. Symptomatic CD patients are at a higher risk of malnutrition and micronutrient deficiencies due to reduced absorption in the small intestine. An individualised plan based on symptoms and nutritional deficiencies should be implemented for these patients.

Patients with CD may need supplementation to address deficiencies in iron, vitamin D, calcium, and vitamin B12. Smoking cessation programmes may also help to reduce exacerbations of CD. Stress management techniques can help to reduce stress and thereby lower the risk of IBD flares. Additionally, there

is some evidence that probiotics may play a role in achieving remission in IBD. Faecal microbiota transplantation (FMT) is a method of establishing healthy intestinal microbiota and may be useful in treating UC. 3,4

Role of the pharmacist

IBD is a complex condition that requires a multidisciplinary approach for effective management. Pharmacists are accessible healthcare professionals, ideally positioned in the community to play an important role in supporting patients with IBD. Pharmacists can educate patients on medication management, methods to reduce adverse effects, and the importance of adherence to the medication regimen. They can also monitor the response to treatment and refer patients to other healthcare professionals when necessary.

Finally, pharmacists can work collaboratively with other healthcare professionals to empower patients, improve clinical outcomes, and reduce the burden on the healthcare system. ●

References

www.ncbi.nlm.nih.gov/

8. Mohammadi O, and Kassim TA

1. McDowell C , Farooq U, and

books/NBK436021/.

(2023). Azathioprine. [online] Nih.

Muhammad Haseeb (2023).

gov. Available at: https://www.

Inflammatory Bowel Disease.

5. Nakashima J, and Preuss CV

ncbi.nlm.nih.gov/sites/books/

[online] Nih.gov. Available at:

(2021). Mesalamine (USAN).

NBK542190/.

https://www.ncbi.nlm.nih.gov/

[online] PubMed. Available at:

sites/books/NBK470312/.

https://www.ncbi.nlm.nih.gov/ books/NBK551714/.

9. Hanoodi M, and Mittal M (2023).

Methotrexate. [online] PubMed. Available at: https://www.ncbi.

2. Crohn’s & Colitis Ireland

nlm.nih.gov/books/NBK556114/.

(2020). FAQs | Crohn’s &

6. Choi J, and Fenando A (2020).

Colitis Ireland. [online]

Sulfasalazine. [online] PubMed.

Available at: https://crohnscoli-

Available at: https://www.ncbi.

10. Sapkota B, Makandar SN,

tis.ie/support/faq.

nlm.nih.gov/books/NBK557809.

and Acharya S (2020). Biologic

3. Lynch WD, and Hsu R (2023).

7. Ardizzone S, Cassinotti A,

line] PubMed. Available at: https://

Ulcerative colitis. [online]

Manes G, and Bianchi Porro, G

www.ncbi.nlm.nih.gov/books/

National Library of Medicine.

(2010). Review: Immunomod-

NBK542200/.

Available at: https://www.ncbi.

ulators for all patients with

nlm.nih.gov/books/NBK459282/.

inflammatory bowel disease?

11. Kalola UK, and Ambati S

Therapeutic Advances in Gas-

(2020). Budesonide. [online]

4. Ranasinghe I, and Hsu R

troenterology, 3(1), pp.31–42.

PubMed. Available at: https://

(2024). Crohn Disease. [online]

doi:https://doi.org/10.1177/

www.ncbi.nlm.nih.gov/books/

PubMed. Available at: https://

1756283x09354136.

NBK563201/.

Response Modifiers (BRMs). [on-

VOL 26 ISSUE 2 : FEBRUARY 2025

Dnord (calcifediol) 255 microgram soft capsules Please refer to the Summary of Product Characteristics (SmPC) for full prescribing information.

Further information is available on request.

Presentation: Soft capsule containing 5 mg of ethanol; 22 mg sorbitol (E420) and 1 mg sunset yellow (E110). Orange, oval, soft gelatin capsule, containing a clear, low viscosity and free from particles liquid. Indications: Treatment of vitamin D deficiency (i.e., 25(OH)D levels < 25 nmol/L) in adults. Prevention of vitamin D deficiency in adults with identified risks such as in patients with malabsorption syndrome, chronic kidney disease, mineral and bone disorder (CKD-MBD) or other identified risks. As adjuvant for the specific treatment of osteoporosis in patients with vitamin D deficiency or at risk of vitamin D deficiency. Dosage and administration: Oral administration. Treatment of vitamin D deficiency and prevention of vitamin D deficiency in patients with identified risks: one capsule once a month. As adjuvant for the specific treatment of osteoporosis: one capsule once a month. Higher doses may be necessary in some patients after analytical verification of the extent of the deficiency.

In those cases, the maximum dose administered should not exceed one capsule per week. Once plasma levels of 25(OH)D are stabilised within the desired range, treatment should be discontinued, or the frequency of administration lowered. Dnord should not be administered with a daily frequency. The dose, frequency and duration of the treatment will be determined by the prescriber taking into account the plasma levels of 25(OH)D, type and condition of the patient and other comorbidities such as obesity, malabsorption syndrome, treatment with corticosteroids. Dnord is recommended when administration spaced in time is preferred. Serum concentrations of 25(OH)D should be monitored after initiation of the treatment, usually after 3-4 months. The potency of this medicinal product is sometimes expressed in international units. These units are not interchangeable with the units used to express the potency of cholecalciferol (Vitamin D) preparations. Renal impairment, elderly or paediatric patients: Please refer to SmPC. Contraindications: Hypersensitivity to calcifediol or to any of the excipients. Hypercalcemia (serum calcium >2.6 mmol/L), hypercalciuria, calcium lithiasis, hypervitaminosis D. Special warnings and precautions: Hypercalcaemia and hyperphosphataemia: To obtain an adequate clinical response to oral administration of calcifediol, an appropriate dietary calcium intake is also required. Therefore, to control the therapeutic effects, the following parameters should be monitored, in addition to 25(OH)D: serum calcium, phosphorus and alkaline phosphatase as well as urinary calcium and phosphorus in 24 hours. A decrease in serum levels of alkaline phosphatase normally precedes the onset of hypercalcemia. Once parameters are stabilized and the patient is under maintenance treatment, the above-mentioned determinations should be performed regularly, especially for serum levels of 25(OH)D and calcium. Renal impairment: To be administered with caution. Use of this drug in patients with chronic kidney disease should be accompanied by periodic monitoring of serum calcium and phosphorus, and hypercalcemia prevention. Transformation to calcitriol takes place in the kidney; thus, in case of severe renal impairment (creatinine clearance of less than 30 mL/min) a very significant reduction in the pharmacological effects may occur. Heart failure: Special caution is required. The patient’s serum calcium should be monitored constantly, especially in patients on digitalis, because hypercalcaemia may occur and arrhythmias appear. Twice-aweek determinations are recommended at the beginning of treatment. Hypoparathyroidism: 1-alpha-hydroxylase is activated by parathyroid hormone. As a result, in case of parathyroid insufficiency the activity of calcifediol may decrease. Kidney stones: Calcaemia should be monitored since vitamin D increases absorption of calcium and may aggravate the situation. In these patients, supplements of vitamin D should be administered only if the benefits outweigh the risks. Prolonged immobilization: In patients with prolonged immobilization, it may be necessary to reduce the dose in order to avoid hypercalcaemia. Sarcoidosis, tuberculosis, or other granulomatous diseases: To be administered with caution since these conditions lead to a greater sensitivity to the effect of vitamin D as well as to an increase of the risk of adverse effects at doses lower than the recommended dose. It is necessary to monitor serum and urinary calcium concentrations in these patients. Laboratory Tests: Calcifediol may interfere with determination of cholesterol (Zlatkis-Zak method), leading to false increases in serum cholesterol levels. International Units (IU) should not be used for determination of the dose of calcifediol as this could lead to overdosing. Instead, refer to the SmPC for full details on dosing. Interactions: Consult SmPC for detailed information on interactions. Fertility, pregnancy and lactation: Calcifediol is not to be used during pregnancy or breastfeeding. Consult the SmPC for further details. Undesirable effects: Unknown frequency: Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, rash, localised oedema / local swelling, and erythema), hypercalcaemia and hypercalciuria. The adverse effects related to vitamin D are associated with increased levels of calcium when an excessive intake of vitamin D may occur i.e. associated with overdose or prolonged treatment. The doses of vitamin D analogues required for hypervitaminosis vary considerably from one subject to another. The adverse reactions due to increased levels of calcium can occur initially or at a later stage. Refer to the SmPC for details on symptoms and treatment of overdose. Legal classification: POM. MA numbers: PA23343/001/001. Further information available from: Nordic Pharma Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin. Date of Prescribing Information: November 2022.

Item code: IE/22/DNO/001-00.

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

Adverse events should also be reported to Nordic Pharma Ireland; info@nordicpharma.ie or +353(0)1 4004141

Date of Preparation: August 2024. Item code: IE-DNO-2400012

References 1. DNORD SmPC: https://www.hpra.ie/img/uploaded/swedocuments/Licence_PA23343-001-001_15112022130834.pdf

dnord.ie

IN FOCUS | Wound care

A time to heal Damien O’Brien MPSI looks at the various considerations in wound care, including common wounds and pharmacological treatments

I

ntroduction

A wound is defined as disruption or damage of living tissue, such as skin, mucous membranes, or organs. Wounds and wound complications can cause significant morbidity and mortality, as well as impose a huge burden on the healthcare system. Wound care is an important aspect of healthcare, encompassing the prevention, assessment, and treatment of various wounds. The goal is to promote the healing of injuries to the skin and surrounding tissues while preventing wound complications.

Pharmacists are accessible healthcare professionals who play a vital role in wound care. Their responsibilities in wound care include providing first aid, advising on pharmacological treatment options, dispensing prescribed medicines, educating patients, and referring patients to other healthcare professionals when necessary. This article will provide an overview of wounds, their classification, effective wound care practices, common conditions, wound assessment, and both pharmacological and non-pharmacological treatment options available.1

Classification

Wounds can occur due to a variety of factors, including trauma, burns, surgery, chemical damage, or underlying conditions such as diabetes, immunological diseases, and arterial or venous insufficiency.

Wounds can be broadly classified as acute or chronic. Acute wounds typically follow a predictable healing pattern and timeframe. Examples of acute wounds include abrasions, lacerations, puncture wounds, and surgical wounds.

It is important to determine the time elapsed since the injury, the likelihood of contaminants in the wound, the

50

timing of the patient’s last tetanus vaccination, and the involvement of neurovascular supply, bony structures, tendon, ligament, and muscle.

In chronic wounds, healing stalls during the normal stages of inflammation and these wounds often fail to heal within three months. This is usually due to underlying conditions, infection, or impaired healing processes.

Examples of chronic wounds include diabetic ulcers, venous ulcers, arterial ulcers, and pressure injuries.1

Effective wound care practices Good wound care practices are essential to prevent wound complications. Wound complications can be severe, including infection or delayed healing, which may

result in discomfort, disability, or even death. Effective wound care requires a patient-centered approach, considering the type of wound, its underlying cause, and the patient’s overall health.

A thorough assessment is crucial for ensuring prompt diagnosis, with proper documentation needed to track the healing process and adjust treatment as necessary. Maintaining a sterile environment is vital to reduce the risk of infection and other complications.

Sterile saline is appropriate for wound cleaning, while proper hand hygiene, the use of gloves, and adherence to infection control protocols are also critical measures. Appropriate wound dressing plays an important role in protecting the wound from contaminants. Proper

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Wound care | IN FOCUS

wound care should address the patient’s needs, promote normal healing, and prevent complications. 2

Assessment and diagnosis

The assessment and diagnosis of wound conditions require a comprehensive overview of the patient’s medical history, nutritional status, mobility, social factors, wound characteristics, wound duration, and any previous trauma. An accurate wound assessment is vital for determining appropriate treatment.

A detailed medical history is necessary to identify underlying conditions that may impact wound healing, such as diabetes, vascular disease, and immunosuppression. The medical history should also gather information about the cause of the wound, previous treatments, prior ulceration, and any allergies.

Assessment of wounds should follow a systematic approach, and the wound assessment tool TIMERS provides a comprehensive method for this process.

TIMERS examines tissue, infection/ inflammation, moisture, wound edge, repair/regeneration, and social factors relating to the wound.1 A thorough assessment of the wound should measure its size, depth, and location, while also evaluating the presence of necrotic tissue and exudate.

Signs of infection, such as increased pain, inflammation, erythema, warmth, odour, and purulent discharge should also be assessed. If infection is suspected, a wound culture may be necessary to identify the pathogen and ensure appropriate antimicrobial therapy.

Blood tests may be required to evaluate the patient’s general health and identify underlying conditions that could impede wound healing. These tests may include a full blood count and blood glucose levels. Imaging studies, such as ultrasound imaging, computed tomography (CT) scans, magnetic resonance imaging (MRI), and x-rays may be useful in assessing deeper tissue involvement in chronic wounds.

Since malnutrition can hinder wound healing, a nutritional assessment

VOL 26 ISSUE 2 : FEBRUARY 2025

may also be required to determine if supplementation is necessary.1,3

Common wound conditions

Wounds can arise in various ways and vary widely in severity and complexity.

Acute wounds are often caused by trauma and generally follow a predictable healing pattern. Examples of acute traumatic wounds include abrasions, lacerations, and puncture wounds.

Surgical wounds are deliberate incisions made during a medical procedure and are typically managed in a controlled environment. Burns, which may be caused by heat, radiation, or chemicals, are classified based on the extent of tissue damage and depth.

Examples of acute traumatic wounds include abrasions, lacerations, and puncture wounds.

Pressure ulcers, also known as bedsores, are injuries to the skin and surrounding tissue. These wounds are typically seen in immobile or elderly patients and occur due to prolonged pressure on the skin. Diabetic foot ulcers involve a breakdown of the skin and deeper tissue of the foot, leading to ulcer formation. They result from mechanical stress applied to the foot combined with neuropathies or peripheral artery disease. Venous leg ulcers occur due to poor venous circulation, which leads to chronic inflammation and breakdown of tissue, often located on the lower legs. 3

Pharmacological treatment

Pharmacological treatment plays a critical role in wound care by helping to prevent infection, treat infection, reduce pain, and promote healing. Neomycin, mupirocin, and fusidic acid are examples of antibiotics commonly used topically to prevent and treat localised wound infections. They are effective in treating mild-to-moderate infections that lack deeper tissue involvement or systemic symptoms. These agents may exhibit dose-dependent effects, with some being bacteriostatic at lower concentrations and bactericidal at higher concentrations.

Topical antibiotics can be applied

directly to the wound or incorporated in dressings. Prolonged use should be avoided to prevent resistance.

Adverse effects of topical antibiotics are generally localised, including erythema, itching, swelling, and irritation. Systemic antibiotics may be necessary for infections involving deeper tissues or presenting with systemic symptoms, such as fever, malaise, or cellulitis.

The antibiotic agent chosen should be selected in line with antimicrobial policy to avoid unnecessary and prolonged administration of antibiotics. The antibiotic regimen should be selected based on culture and sensitivity.

Examples of systemic antibiotics used for wound infections include flucloxacillin, clindamycin, doxycycline, and cephalexin.

Systemic antibiotics are usually welltolerated, but common adverse effects include nausea, vomiting, diarrhoea, skin rashes, and allergic reactions.4,5 Analgesia is an important factor in wound care, particularly in burns, acute traumatic wounds, and pressure ulcers.

Pain is often experienced by patients and can be frequently overlooked in wound care. It can negatively affect wound healing and significantly reduce the quality of life for patients. Pain is multifactorial, involving both physiological and psychological aspects.

Proper assessment of pain, including its type, duration, and severity, is necessary to establish an effective pain management plan.

The World Health Organisation has a three-step approach for analgesia that can be modified for wound pain. Step 1 involves the use of paracetamol and/or a non-steroidal anti-inflammatory drug (NSAID), with or without an adjuvant.

Examples of NSAIDs that can be used include ibuprofen, diclofenac, naproxen, and meloxicam. NSAIDs are an important pharmacological intervention due to the inflammatory nature of chronic wounds. Adjuvants that can be used in Step 1 include anticonvulsants, tricyclic antidepressants, benzodiazepines, and corticosteroids.

If pain is not controlled with Step 1

51

IN FOCUS | Wound care

approaches, an opioid such as codeine or tramadol can be added to the initial medication for Step 2 treatment. Step 3 treatment approaches are used if Step 2 medications fail. This involves discontinuing Step 2 medications and using more potent opioids, such as morphine. The adverse effects of analgesics should be considered, with common adverse effects of opioids including respiratory depression, nausea, constipation, sedation, and risk of dependency. The risk of analgesics exacerbating further symptoms and complications should also be considered.6 The use of corticosteroids may also be considered in the pharmacological management of wounds. Topical corticosteroids, including clobetasone and betamethasone, may be used in cases where an excessive inflammatory response hinders wound healing. However, topical corticosteroids can increase the risk of infection and delay the healing of open wounds if used inappropriately. The use of corticosteroids is considered off-label use and should only be initiated and overseen by specialist services.7 Systemic corticosteroids can be useful in the treatment of ulcers secondary to connective tissue diseases, such rheumatoid arthritis and other disorders.

However, prolonged use of corticosteroids can negatively affect wound healing, with additional adverse effects, such as reduced bone mass density, mood alterations, adrenal insufficiency, and increased blood glucose levels. Silver sulfadiazine can also be used topically, as it acts on the cell membrane and cell wall to exert a bactericidal effect.

It is often used to prevent infection and promote healing in burns, superficial skin infections, and ulcers. 8

Non-pharmacological treatment

Non-pharmacological interventions are important in wound care and can be used as monotherapy or to complement pharmacological treatment options. These methods aim to address underlying factors that hinder wound

52

healing, optimise the wound healing environment, and prevent complications.

Honey, with its antimicrobial properties, is often used in dressings to maintain a moist environment and stimulate tissue regeneration. 9 Proper nutrition and hydration are essential for optimising wound healing. A balanced diet, rich in minerals and vitamins — particularly vitamins A, C, and E — is crucial to supporting immune function and tissue repair. Smoking reduces oxygen delivery to tissues and impedes wound healing. Smoking cessation should be encouraged to improve blood circulation and enhance wound healing.1 Techniques such as offloading can be useful for patients with pressure injuries and diabetic foot ulcers. This involves reducing pressure on the affected wound area to promote healing. Compression therapy, using compression dressings or stockings, is an important intervention for treating venous leg ulcers. Debridement, the removal of necrotic tissue, is essential in the treatment of certain chronic wounds. It can be performed in a variety of ways, including chemical, mechanical, surgical, and autolytic methods.8 Wound healing is optimised in a moist and clean environment, as this facilitates the movement of growth factors and epithelial cells to the wound bed. Dressing selection should be individualised based on each patient’s needs and the characteristics of the wound. An ideal dressing should create a clean and moist environment, remove

excess exudate, prevent desiccation, allow gas exchange, be impermeable to microbes, and be free of toxic materials.

Infected wounds and those with excessive exudate should be monitored and changed more frequently, while non-infected wounds may require less frequent changes. Dressings can vary widely in their properties and may include alginates, hydrocolloids, hydrogels, foam dressings, and silicone dressings. 8

Role of the pharmacist

Pharmacists are ideally positioned in the community to play a vital role in wound care, extending beyond their traditional role of dispensing medications. Wound care is a multifaceted area where pharmacists contribute significantly to improving patient outcomes.

Pharmacists are heavily involved in medication management — ensuring appropriate treatment choices, screening for drug interactions, and promoting adherence to medication.

They can educate and support patients on crucial aspects of wound care, including infection control, dressing changes, nutritional support, and smoking cessation. Pharmacists can also monitor for signs of infection and refer patients to their GP when necessary to prevent complications. Additionally, they can collaborate with other healthcare professionals to develop and implement comprehensive care plans tailored to each individual patient, ensuring continuity of care, and enhancing clinical outcomes. ●

References

AA (2023). Topical antibiotic

7. Use of topical steroids in

1. Nagle SM, Waheed A, and

treatment in dermatology. Anti-

wound care where an excessive

Wilbraham SC (2023). Wound

biotics, 12(2), p188.

inflammatory response may be

assessment. [online] PubMed.

5. Zabaglo M, and Sharman T

present. Dec 2020. (n.d.)

2. Evans L (2015). The importance

(2024). Postoperative wound

8. Enoch S, Grey JE, and Harding

of effective wound care. [online]

infection. [online] PubMed.

KG (2006). Non-surgical and

Open Access Government.

6. Bechert K, and Abraham SE

drug treatments. British Medical

3. Grey JE, Enoch S, and Harding

(2019). Pain management and

Journal, 332(7546), p900-903.

KG (2006). Wound assessment.

wound care. The Journal of the

9. Tashkandi H (2021). Honey

British Medical Journal, [online]

American College of Certified

in wound healing: An updated

332(7536), p285-288.

Wound Specialists, [online]

review. Open Life Sciences,

4. Dallo M, Patel K, and Hebert

1(2), p65-71.

[online] 16(1), p1091-1100.

VOL 26 ISSUE 2 : FEBRUARY 2025

Advanced Woundcare

A solution for every stage of the wound healing process Surgical • Foam • Transparent • Dressing Tape • Swabs Discover an innovative wound management range that covers all phases of wound healing.

Developed especially for the treatment of acute and chronic wounds, our range offers effective, patient friendly solutions for conditions such as acute wounds, chronic wounds, ulcers and burns.

Our full Advanced Woundcare range is available in pharmacies nationwide Find out more about our Advanced Woundcare range, simply scan the code or visit FLEMINGMEDICAL.IE/pharmacy/advanced-woundcare

WWW.FLEMINGMEDICAL.IE

Freephone: 1800 307777 Email: pharmacy@flemingmedical.ie

IN FOCUS | Nutrition

Fuel for life Damien O’Brien MPSI provides an overview of micronutrients and macronutrients, oral supplements, and the causes and effects of malnutrition

I

ntroduction

Nutrition is the intake of food to meet the body’s dietary needs, and it plays an integral role in maintaining overall health and wellbeing. Nutrition impacts the development of each individual at every stage of their life cycle, from conception to death. Good nutrition is required for immunity, lowering the risk of disease, safer pregnancy, and longevity. However, achieving adequate nutrition can be difficult for many adults, particularly the elderly and those with chronic diseases.

Physical difficulty eating, medical conditions, and psychological issues can lead to malnutrition. Malnutrition is, therefore, a significant public health concern. Malnutrition can lead to worsening health outcomes, delayed recovery times and increased hospital admissions — causing a significant increase in morbidity and mortality. Pharmacists can play an important role in identifying and addressing nutritional challenges. This article delves into the importance of micronutrients and macronutrients, the causes and effects of malnutrition, and the importance of interventions such as oral nutritional supplements (ONS).1

Good nutrition

For an adult, good nutrition involves a diet with appropriate consumption of macronutrients to allow energetic and physiological requirements to be fulfilled without excess intake.

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Nutrition | IN FOCUS

Good nutrition also encompasses sufficient micronutrients and hydration to meet the physiological requirements of the body.

Carbohydrates, fats and proteins are macronutrients that supply the body with energy necessary for the cellular processes required for daily functioning. Vitamins and minerals are micronutrients that are required in smaller amounts for the body to achieve normal growth, development, metabolism and physiological functioning.

Water is the principal component of the body and accounts for the majority of body mass. It provides essential hydration for the body and carries micronutrients and electrolytes. A diet with appropriate proportions of macronutrients and micronutrients, along with good intake of dietary fibre, is important for health and wellbeing. There are numerous benefits associated with good nutrition, including:  Improved longevity.  Supporting healthy skin, teeth and eyes.  Building a stronger immune system.  Supporting healthy pregnancy and breastfeeding.  Strengthening bones and the musculoskeletal system.  Lowering the risk of cardiovascular disease, type 2 diabetes and certain cancers.  Improving functioning of the digestive system.  Maintaining a healthy body mass. 2,3

Macronutrients Macronutrients — carbohydrates, proteins and fats — are essential for energy production, growth and repair.

Each has a unique set of properties that play an important role in cellular processes in the body. Adequate nutrition involves achieving the right balance of macronutrients, which is crucial for preventing malnutrition and optimising overall health and wellbeing.4

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Protein is an essential nutrient in the human body for maintaining muscle mass, repairing tissue, and supporting immune function Proteins

Proteins are large molecules composed of one or more amino acid chains.

Amino acids are linked by peptide bonds, which are hydrolysed in the stomach by hydrochloric acid and protease enzymes to allow the absorption of essential amino acids.

Protein is an essential nutrient in the human body for maintaining muscle mass, repairing tissue, and supporting immune function. It is the major structural component of body cells and one of the building blocks of body tissue. Protein is also a fuel source, providing 4 kilocalories (kcal) or 17 kilojoules (kJ) per gram. Meat, fish, eggs and dairy products are excellent sources of dietary protein, while plantbased protein sources include nuts, seeds and legumes.

Adequate dietary protein intake is essential for maintaining lean body mass throughout adulthood.

Brittle nails and hair, feeling weak or hungry, mood changes and muscle weakness may be signs of a protein deficiency. Protein deficiency may also predispose an individual to stress fractures of the bones.

Adequate daily protein intake can reduce the decline in physical functioning in the elderly. This helps mitigate the age-related loss of muscle strength and function and reduces the likelihood of developing mobility limitations. 4,5

Carbohydrates

Carbohydrates are simple sugars, occurring either as monosaccharides or chains of monosaccharides that form disaccharides, oligosaccharides or polysaccharides. The bonds of these chains are either hydrolysed in the digestive tract or are resistant to

hydrolysis, as in the case of dietary fibre.

Carbohydrates are the body’s primary source of energy, particularly for brain function and physical activity, providing 4 kcal or 17 kJ of energy per gram. Carbohydrates are also a component of important coenzymes and genetic material in the body, while dietary fibre plays a vital role in maintaining the proper function of the digestive system. 4

Fats

Fats are composed of glycerol and fatty acids. They are a concentrated source of energy in adults, providing 9 kcal or 38 kJ per gram. Fats also play an important structural and metabolic role in the body.

Additionally, they are essential for absorbing fat-soluble vitamins (A, D, E and K). Dietary sources of fats include meat, dairy products, eggs, oily fish, nuts, and seeds.

Four categories of dietary fats exist: Monounsaturated fats, polyunsaturated fats, saturated fats, and trans fats. Omega-3 and omega-6 are essential fatty acids that must be obtained from dietary sources, with some evidence suggesting they are beneficial for reducing inflammation and supporting brain health. 4,6

Micronutrients Micronutrients include minerals and vitamins, which are required in smaller amounts in the body but are crucial for health and wellbeing. Micronutrient deficiencies are common among malnourished adults and can lead to many health complications. Vitamins A, D, E and K are fat-soluble vitamins, which are easily stored in body fat upon absorption. Vitamins B and C

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IN FOCUS | Nutrition

are water-soluble vitamins, which are not easily stored in the body and are eliminated through excretion. 7 B vitamins are a diverse range of vitamins essential for cell metabolism, nerve function and red blood cell formation. These include thiamine (B1), riboflavin (B2), niacin (B3), pantothenic acid (B5), pyridoxine (B6), biotin (B7), folate (B9) and cobalamin (B12). Dietary sources of B vitamins include meat, dairy products, eggs, spinach, and legumes.

While deficiency is possible for all B vitamins, toxicity is rare due to their water solubility. Vitamin C is vital for wound healing, bone formation, collagen synthesis, immune system support, and iron absorption. It is found in citrus fruits, berries, and other fruits and vegetables. Deficiency can lead to scurvy, poor wound healing, bleeding gums, and tooth loss .7 Vitamin D is required for the maintenance of serum calcium concentration within the normal physiological range for musculoskeletal health. It can be obtained through dietary consumption of oily fish, meat, liver, eggs and dairy products. It is also produced in the skin upon exposure to sunlight.

Vitamin D deficiency is particularly prevalent in the winter months due to limited sunlight exposure. Deficiency, especially in older adults, can increase the risk of osteoporosis and fractures. 7 Vitamin A is essential for cellular differentiation, immune function, and vision. A deficiency of vitamin A can lead to vision problems. Meat, fish, dairy products and colourful fruits and vegetables are common sources of this vitamin. Vitamin E is an antioxidant, protecting cells from oxidative stress and regulating immune function. It is found in a wide range of foods, including nuts, seeds, fish, and vegetables.

Vitamin E deficiency is very rare and usually observed only in individuals with fat absorption issues. Vitamin K is required for maintaining normal coagulation in the body. It is obtained

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from the diet though green leafy vegetables, meat, and dairy products.

Dietary deficiency is also rare but can lead to reduced blood clotting, increased bleeding, and increased prothrombin time. 7 There are also several minerals required by adults, in varying quantities, to perform a wide range of physiological functions for maintaining overall health and wellbeing. Calcium is vital for bone and dental health, with deficiency potentially leading to osteoporosis.

Iron is critical for red blood cell formation, and its deficiency can result

While deficiency is possible for all B vitamins, toxicity is rare due to their water solubility in anaemia. Magnesium is important for enzymatic and muscular function, while chloride and sodium regulate body fluids and maintain electrolyte balance. Zinc and selenium are essential for immune function and wound healing.

Potassium and iodine are also essential trace minerals, contributing to various physiological processes.7

Malnutrition

Malnutrition refers to an imbalance in nutrient intake, resulting in deficiencies or excesses. Undernutrition occurs when the body does not obtain sufficient macronutrients and micronutrients required for the normal functioning, while overnutrition occurs when the body receives excessive nutrition.

It is estimated that one-third of adult patients admitted to acute hospitals or long-term care facilities are at risk of malnutrition.

Malnutrition particularly affects vulnerable populations, including the elderly, individuals with chronic diseases, and those recovering from surgery or illness. 8,9

Causes of malnutrition

There are several potential causes of malnutrition, which can be physical, medical or psychosocial.

Physical causes may include dysphagia — difficulty swallowing — common among stroke patients and individuals with neurological disorders, leading to malnutrition due to an inability to swallow. Poor dental health can also make eating painful or difficult. 8,9 There are a wide range of medical causes of malnutrition. Inflammatory bowel disease can disrupt an individual’s ability to digest food or absorb nutrients. Nausea, vomiting, dry mouth or altered taste perception caused by disease or treatment can reduce dietary intake and lead to malnutrition. Chronic diseases, including cancer, chronic obstructive pulmonary disease and diabetes, may increase energy needs while decreasing appetite.

Psychosocial factors can also play a significant role in malnutrition.

Mental health conditions may greatly impact appetite and eating habits.

Additionally, financial constraints, low education levels, and substance abuse may contribute to malnutrition.8,9

Consequences of malnutrition

Malnutrition affects the function and recovery of every organ system, leading to severe health consequences. Reduced muscle strength and function are among the primary consequences, contributing to frailty and falls. Malnutrition also weakens the immune system, increasing the risk of infections and delaying wound healing and recovery from illness. Furthermore, malnutrition may contribute to cognitive decline

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Nutrition | IN FOCUS

and poor mental health outcomes.

Lastly, malnutrition can negatively affect cardiac, respiratory and gastrointestinal function.8

Oral nutritional supplements (ONS)

ONS are food products specifically designed to provide energy, protein and other nutrients. They are a mainstay in managing malnutrition in adults with reduced appetite or specific dietary restrictions. ONS are nutritionally complete and provide a balanced blend of micronutrients and macronutrients in an easy-toconsume formulation. Patients should continue consuming regular meals and snacks, with ONS serving as an addition to, rather than a replacement for, regular meals.

ONS come in various forms, including powdered supplements, ready-made milk-based supplements, or juice-style supplements. For

References 1. Nutrition (2024). Introduction. [online] World Health Organisation - Regional Office for the Eastern Mediterranean. Available at: https://www.emro.who.int/ health-topics/nutrition/introduction.html.

2. Cena H, and Calder PC (2020). Defining a Healthy diet: Evidence for the Role of Contemporary Dietary Patterns in Health and Disease. Nutrients, [online] 12(2), pp.1–15 3. Centres for Disease Control and Prevention (2021).

Benefits of Healthy Eating. [online] Centres for Disease Control and Prevention.

Available at: https://www.

patients with difficulty swallowing, semi-solid or pudding-type supplements may be prescribed.

Evidence has demonstrated that ONS can effectively increase protein intake, improve nutritional status, enhance muscle strength and function, and improve the quality of life for patients with malnutrition or at risk of malnutrition. ONS are also valuable for patients recovering from illness or surgery. For individuals with swallowing difficulties, texturemodified diets or thickened liquids may be necessary to reduce the risk of aspiration.10,11

Role of the pharmacist

Malnutrition is a significant and often overlooked issue among adults, particularly affecting the elderly and those with chronic illnesses. Pharmacists, as accessible healthcare professionals, play a critical role in promoting adult

cdc.gov/nutrition/resources-publications/benefits-of-healthy-eating.html.

4. Espinosa-Salas S, and Gonzalez-Arias M (2023).

Nutrition: Macronutrient Intake, Imbalances, and Interventions. [online] PubMed. 5. Mendonça N, Hengeveld LM, Visser M, Presse N, Canhão H, Simonsick EM, Kritchevsky SB, Newman AB, Gaudreau P, and Jagger C (2021). Low protein intake, physical activity, and physical function in European and North American community-dwelling older adults: a pooled analysis of four longitudinal aging cohorts. The American Journal of Clinical Nutrition, 114(1), pp.29–41.

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nutrition. They are often the first point of contact for individuals experiencing loss of appetite, weight loss and fatigue. Pharmacists can recognise these signs and refer patients to appropriate healthcare providers.

Pharmacists have the knowledge to educate patients on nutrientdense foods, highlighting the importance of macronutrients and micronutrients. This is particularly important for vulnerable groups and may involve advice on dietary intake and supplementation. They can also counsel patients on ONS options, explaining how to integrate them into their diet and developing suitable plans for nutritional supplementation.

Additionally, pharmacists collaborate with dietitians, general practitioners and other healthcare professionals to develop comprehensive management plans for patients, ensuring continuity of care and optimising patient outcomes. ●

6. Field CJ, and Robinson L (2019). Dietary Fats. Advances in Nutrition, [online] 10(4), pp.722–724.

7. Espinosa-Salas S, and Gonzalez-Arias M (2023). Nutrition: Micronutrient Intake, Imbalances, and Interventions. StatPearls. [online] 8. Saunders J, and Smith T (2010). Malnutrition: Causes and consequences. Clinical Medicine, 10(6), pp.624–627.

9. HSE (2016). Malnutrition in Ireland - HSE.ie. [online] HSE.ie. Available at: https:// www.hse.ie/eng/services/ list/2/primarycare/community-funded-schemes/ nutrition-supports/malnutrition-in-ireland/.

10. How to use oral nutritional supplements: A guide for adult patients, their carers and families (n.d.). Available at: https:// www.hse.ie/eng/services/ list/2/primarycare/ community-fundedschemes/nutritionsupports/how-to-use-oralnutritional-supplements.pdf.

11. Zhang H, Qiu Y, Zhang J, Ma Z, Amoah AN, Cao Y, Wang X, Fu P, and Lyu Q (2021). The effect of oral nutritional supplements on the nutritional status of community elderly people with malnutrition or risk of malnutrition. Asia Pacific Journal of Clinical Nutrition, [online] 30(3).

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LIFE | Food and Drink

The well-deserved revival of butter

I

Tom Doorley spreads the word about how butter has made a comeback

t’s now almost a decade since food giant Unilever got out of margarine production. The inventors of Flora saw the writing on the wall and cut their losses as the rehabilitation of longdemonised butter and other dairy fats moved relentlessly forward. In doing so, perhaps they also anticipated the revelations that have since been made about ultra-processed foods.

Margarine and 'spreads' are the very definition of ultra-processing.

Butter’s negative reputation began in 1913 when Russian pathologist Prof Nikolai Anitschkow conducted an experiment in which he fed large amounts of cholesterol to a group of rabbits, which led to atherosclerosis.

Rabbits are herbivores by nature and are not designed to process cholesterol, which made them particularly vulnerable to these effects.

Ancel Keys, in the 1940s, continued with his lipid hypothesis, using cherry-picked statistics and ignoring inconvenient figures, to establish a link between saturated fat and cardiovascular disease.

Research

Scroll down to 2018 and the conclusion of a study (BMJ 2018;362:k3862) by scientists at McMaster University in Canada: “Our findings support that consumption of dairy products might be beneficial for mortality and cardiovascular disease, especially in low- and middle-income countries where dairy consumption is much lower than in North America or Europe.”

The British Medical Journal provided the following summary: “People who consume more than two servings of dairy products each day have lower

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rates of cardiovascular disease and mortality than those with lower intakes, a global observational study has reported.”

My history with butter

Did this have any effect on my own relationship with butter? Of course

not. I had long been suspicious of the vested interests involved in the demonisation of dairy products and it was not lost on me that much dietary research was funded by companies whose business is food processing. I was also conscious that Irish people, for generations, ate prodigious

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Food and Drink | LIFE

quantities of butter, and also cooked with it, along with other animal fats like lard and dripping.

When I was a small boy in the 1960s, this was starting to change. My parents resisted the TV commercials for Blue Band, “the margarine that spreads straight from the fridge”, and stuck with butter. But my mother used blocks of hydrolysed vegetable fats, packed with transfats, in her baking and I recall Mazola corn oil making an appearance.

Those were the days before olive oil, of course. If you read Elizabeth David back then — and my mother, an excellent cook, didn’t — her advice in A Book of Mediterranean Food was to seek out such exotic ingredients in Old Compton Street in Soho. When my mother first used olive oil in the kitchen, it came from the local chemist’s, where it was sold for softening ear wax rather than dressing salads. The mind boggles as to how it tasted.

Later, there were small bottles of olive oil with the Goodall’s label. I got my first whiff of the distinctive aroma of warm olive oil, in a pan, in this form.

Well, we are a very long way from there now, although you can still buy Mazola and (reformulated) Blue Band if you really want to.

Between the cupboard and the fridge, our stock of fats is pretty simple. There’s olive oil — the basic one from Aldi – for frying, various extra virgins (mainly Greek and Spanish) for dressings and flavour, roasted sesame oil, butter, and James Whelan Butchers’ beef dripping (which is sold in Fortnum & Mason and Harrods, incidentally).

Better with butter

But, ah, butter! It’s hard to beat. Just think of hot buttered toast, perhaps with Marmite or Gentleman’s Relish.

Toasted crumpets with honey. New potatoes cooked with a little fresh mint then split and generously anointed with butter and a touch of sea salt. Asparagus, globe artichokes, peas, new season carrots. None of these would be the same with even the

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best olive oil.

When I make a ragù — often called a bolognese sauce — (and always with tagliatelle, ever since I visited Bologna) and have let it bubble away for hours, the final addition is always a big knob of butter. And when I cook spaghetti aglio e olio, which is simply garlic, olive oil, and parsley with pasta, I do something that is probably against the

I had long been suspicious of the vested interests involved in the demonisation of dairy products ... law in Italy: I melt in some butter just before dishing it up and lashing on the grated Parmesan.

Amongst my favourite more conventional applications of butter are beurre noisette, where butter is melted and heated just until it browns a little, developing a caramelised flavour. A little lemon juice is then squeezed in and perhaps some capers added. There is nothing better with a sole on the bone. Browned butter with

crisped sage leaves is also the classic accompaniment for ravioli, especially when filled with ricotta and spinach.

Two essential, luxurious classic sauces depend on butter for their key character: Béarnaise and hollandaise.

This is how I make mine. Take half a pound of butter from the fridge and cut into small cubes an hour before you want to make the sauce.

For hollandaise, take a tablespoon of white wine vinegar and add it to three tablespoons of water in a small saucepan along with a dessert spoon of finely chopped shallot and a few crushed peppercorns. Reduce it to one tablespoon and allow to cool.

Strain into a double boiler, over hot, but certainly not boiling water, and mix with the yolk of an egg and stir until the mixture covers the back of a spoon — be careful not to overheat!

Now whisk in the butter, two or three cubes at a time and when all is combined, you have a hollandaise sauce. For béarnaise, start with tarragon vinegar (or just add some fresh tarragon leaves) and proceed in the same way.

Broadly speaking, hollandaise is good with fish, béarnaise with steak.

Both are… well, simply fabulous. And a very effective way of boosting your butter intake! ●

WINE OF THE MONTH Chardonnay is the only grape I’ve ever known to exhibit a 'buttery' character and Penfolds Max’s Chardonnay 2019 (€24.95, O’Brien’s), named in honour of the great Australian winemaker, Max Schubert, is a case in point. But, of course, there’s more to it than that, including a subtly toasty touch of oak and refreshingly cool climate fruit thanks to the altitude of the Adelaide Hills vineyards. If you like white Burgundy, but despair at the prices, this is not quite the same, but certainly heading in the same direction.

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LIFE | Book review

Important examination of the role of Irish medics in World War II Prof Brendan Kelly reviews a book that provides immaculate attention to detail

W

ar presents deep challenges to medicine.

The sheer scale of injuries, illnesses, and fatalities can feel overwhelming. The psychological consequences are similarly severe, both during times of conflict and afterwards.

In addition, there are ethical and moral complexities for health professionals who seek to prevent and treat injuries and distress during wars which they might believe are unjust.

Against this background, the history of medicine in war merits close, sensitive attention, with an awareness of historical facts, medical advancements, and the ethical nuances of medical involvement in conflict. This new book, Irish Doctors in the Second World War, meets these needs by combining immaculate attention to detail with an acute awareness of the broader context of medical involvement in war. It is a fascinating read and an invaluable resource for medical historians.

The book starts with a foreword by Kevin Myers and goes on to chart the varied contributions of Irish doctors to the war in an involving, engaging way.

Various improvements in healthcare between the two World Wars meant that field medicine was very different in the Second World War compared to the First, and this is demonstrated well throughout the text. The machinery of war also shifted over this period, as did the ways in which the conflict unfolded at ground-level for the troops and at the level of geopolitics.

This was a uniquely destructive, terrifying human conflict.

Irish doctors were involved in medical roles throughout this war in many different ways. In order to tell their story, the book starts with a useful timeline of the war and then outlines details of medals and awards received, and the experiences of

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Irish doctors in Europe and North Africa (1939-1945), in the Far East, and as prisoners of war. It is especially interesting to see that prisoner of war experiences differed significantly across various locations (ie, in Europe and the Far East).

Chapter 6 is devoted to ‘Profiles in Gallantry and Professionalism by Irish Doctors’. This chapter demonstrates the breadth and the magnitude of contributions made by Irish medics.

To take one example, Dr Peter May commanded a motor ambulance convoy during the war and was later awarded an OBE (Officer of the Order of the British Empire). Major May was “responsible for the care and welfare of thousands of casualties, from forward casualty clearing station to railroad or hospital ship port. It was due to his unbound enthusiasm that, although the distance involved was far greater than could have been anticipated, there was at no time any hitch and an even flow of casualties along the line of evacuation was always ensured.”

Part two of the book presents a ‘Roll of Honour of Irish Doctors Who Served in the Second World War’. This list is presented alphabetically, with details of medical qualifications, military service,

and, often, additional information about the individual doctor. Reading through these academic achievements and contributions to war medicine, it is hard not to feel both admiration and sadness at the deployment of such expertise in the context of war.

While their work was necessary given the advent of the conflict, there was enormous opportunity cost. The expertise, dedication, and compassion of these doctors could have been much better used in peacetime.

This sense of tragedy is epitomised in a photograph of Bob Collis, who “was among the first medics to attend the Belsen concentration camp after its liberation by Allied troops”. It is heartening that medics arrived to provide what assistance they could at that point and it is wonderful that Irish doctors played this humanitarian role.

However, it is profoundly disheartening to reflect on the barbarity of the machinery of war that made this necessary in the first place, and the incalculable suffering and losses that resulted from the conflict.

This is a beautifully produced book.

Enormous credit is due to the authors and its publisher, Merrion Press, for their clear text, plentiful photographs, and high production values. It is a splendid contribution to the history of Irish medicine and the history of the Second World War and is an absorbing read.

In the end, the stories of the achievements of these doctors will always be tinged with the sadness of the context.

The authors note that just over 2,000 Irish doctors and medical students served with the British forces. Their work was vital and life-saving, but only because of the occurrence of this senseless, barbaric conflict to begin with.

There is always an alternative to war. These medical achievements were essential and extraordinary, but none of this should have been necessary. ●

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PRODUCTS

Holland & Barrett Ireland announces 2025 charity partnership with Barretstown Health and wellness retailer Holland & Barrett has announced it is to partner with well-known children’s charity Barretstown in 2025. Barretstown provides free, life-changing therapeutic camps and programmes for children living with cancer and other illnesses, as well as providing support to their families.

Holland & Barrett has committed to raising vital funds via employees’ fundraising efforts and customer donations. Staff will participate in a range of fundraising events and challenges nationwide, starting with Barretstown’s Annual Dublin Mountains Challenge Fundraiser in May. One of the cornerstone events for the partnership, the fundraiser will see participants trekking through the picturesque Dublin Mountains to raise much needed funds.

Customers can also support the cause by donating at till points across Holland & Barrett’s 68 Irish stores, and online.

Funds raised will have a significant impact for the 27,000 campers that Barretstown hopes to help through its residential and outreach programmes this year. To sponsor a full weekend camp for one family, and give them the opportunity to rest, heal, and laugh together, costs €3,024.

Adam Moore, Director of Holland & Barrett stores in Ireland, said “I am extremely proud and honoured to be partnering with Barretstown.

Having already had the privilege of meeting some of the amazing Barretstown staff and volunteers, I can say first-hand, the work they are doing is truly transformational.

Holland & Barrett has built a strong connection with our Irish customers, and we are eager to give back to the community that has supported us.

Partnering with Barretstown as our chosen Irish charity was a natural and heartfelt decision, as it aligns perfectly with our values. I am excited to see what our stores and customers can do as we

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Adam Moore, Director of stores in ROI, and Dee Ahearn, CEO of Barretstown

aim to raise vital funds, allowing us to help support as many children living with serious illness and their families as possible.”

Dee Ahearn, CEO of Barretstown, added: “We are delighted to be chosen as Holland & Barrett’s new charity partner this year and, on behalf of all the children, families, volunteers, and staff at Barretstown, I would like to extend my sincere thanks to them for supporting our vital cause. It is through partnerships like this that we can continue to serve children with cancer and other serious illnesses, and their families, as well as expanding our medically endorsed camps and programmes.

“We are excited for Holland & Barret to launch this partnership with the pennies round-up initiative at tills in each of its 68 stores in the country. This is a fantastic opportunity and a great start to our 2025 fundraising campaign. The team at

Barretstown look forward to working closely with Holland & Barrett across the year on a number of innovative initiatives that will deliver real impact.”

In addition to fundraising, Holland & Barrett colleagues will take part in team-building days and ‘Helping Hands’ volunteering projects at Barretstown. These activities, which include painting, gardening, planting flower beds, and general housekeeping, will help ensure Barretstown’s facilities are safe, welcoming, and ready to host families for their camp experiences.

Holland & Barrett and Barretstown encourage the public to get involved and support Barretstown’s work.

Visit Barretstown.org to learn more about their programmes, ways to donate, or ways to get involved.

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PRODUCTS

One-quarter of people who used mobile health check advised to see their GP Almost a quarter of people who used a mobile health unit to have a heart health check were advised to see their GP for further assessment, a report has revealed. And in one case a patient’s blood pressure (BP) reading was so high that they ended up in A&E. The Irish Heart Foundation’s Mobile Health Unit, supported since 2022

by Pfizer Healthcare Ireland, travels the country offering free heart health checks, including BP, pulse checks, and lifestyle assessment.

In 2024, the charity’s nurse-led vehicle provided 6,000 free checks to communities and groups across the 26 counties. But when researchers from South East Technological University (SETU) evaluated the Unit’s effectiveness they found that dozens of patients needed further check-ups after the health check nurse identified signs of high BP. High BP, ‘the silent killer’, is a leading cause of cardiovascular disease, the main cause of death globally. A sample of 300 men and women who used the Mobile Health Unit showed that more than a fifth (22.1 per cent) were found to have high BP, while almost double that number (42.9 per cent) had BP considered higher than normal.

Moreover, some 39.5 per cent reported having no prior awareness of their BP levels and almost a quarter (23.2 per cent) were referred to their GP based on the readings.

Six weeks later, 182 participants completed a follow-up questionnaire over the phone, which revealed that of those who were referred to their doctor, 28.2 per cent underwent additional testing, such as using an ambulatory BP monitor.

A total of 10.3 per cent received a diagnosis of high BP and began taking medication, while 2.6 per cent went to the emergency department due to dangerously high BP levels.

The Mobile Health Unit checks also inspired lifestyle changes: 20.9 per cent made dietary improvements; almost 20

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Tracy James (left), Health Check Nurse Manager, Irish Heart Foundation, and Deb Mangone, Country Manager, Pfizer Healthcare Ireland, in the Irish Heart Foundation’s Mobile Health Unit Picture: Leon Farrell/Photocall Ireland

per cent became more physically active; 1.1 per cent quit smoking; and the same proportion reduced or avoided alcohol.

Janis Morrissey, director of health promotion, information, and training with the Irish Heart Foundation, said the findings underline the importance of the charity’s work in identifying people at high risk of heart disease and stroke.

“The findings from the SETU report are crucial, as 80 per cent of premature heart disease and stroke is preventable,” she said. “The Mobile Health Unit service plays a vital role in identifying people at risk.

“Unfortunately, what you don’t know could kill you as high blood pressure, in the vast majority of cases, has no symptoms. The good news is that, once diagnosed, it is easily managed.

Everyone aged over 30 should get checked every five years and a GP can assess risk levels and may advise more frequent checks.

“We rely on the generosity of the general public and corporates like Pfizer Healthcare Ireland to be able to provide the Mobile Health Unit service.”

Country Manager of Pfizer Healthcare Ireland, Deb Mangone, said: “Pfizer is delighted to support this worthwhile initiative, and it is very rewarding to see the positive impact the Mobile Health Unit is having on the lives of patients across Ireland who may otherwise not have accessed health services or treatment.”

For more information on the Mobile Health Unit, visit irishheart.ie.

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PRODUCTS

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

Neuraxpharm to launch BRIUMVI (ublituximab) in Ireland for the treatment of relapsing multiple sclerosis Neuraxpharm Ireland, part of Neuraxpharm Group, a European speciality pharmaceutical company focused on the treatment of central nervous system disorders, has announced the launch of BRIUMVI (ublituximab) in Ireland for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease.

BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells.

Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion.

In clinical studies, patients who received BRIUMVI had a median

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B-cell depletion of 97 per cent 24 hours after the first dose.

BRIUMVI is administered as a onehour infusion twice a year following an initial dose (administered over four hours), thereby limiting the time spent in the infusion suite for the patient and reducing the burden on the healthcare provider.

More than 9,000 people live with MS in Ireland, and significantly more women than men are diagnosed with MS. Around 85 per cent of all people with MS are diagnosed with RMS. Country Manager of Neuraxpharm Ireland, Rose Brady, said: “We are delighted to make BRIUMVI available to MS patients and healthcare providers in Ireland.

"The launch of BRIUMVI is an important milestone for Neuraxpharm and demonstrates our commitment to bring innovative treatments to patients with multiple sclerosis in Ireland.”

Government has announced plans to ensure that all women receive the same level of allowance for postmastectomy 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.

Speaking at the time, then-Minister for Health Stephen 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 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.

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PRODUCTS

Guselkumab: Robust induction and maintenance effects in ulcerative colitis Results published in The Lancet show TREMFYA (guselkumab) achieved robust induction and maintenance effects in ulcerative colitis, with clinically meaningful improvements across clinical, endoscopic, histologic, symptomatic, and patient-reported outcomes Johnson & Johnson recently announced that The Lancet has published data from the phase 3 QUASAR studies evaluating the efficacy and safety of TREMFYA (guselkumab) as an induction and maintenance therapy in adult patients with moderately- to severelyactive ulcerative colitis.

Results from the QUASAR programme demonstrated that compared to placebo, significantly greater proportions of patients achieved the primary endpoint of clinical remission at Week 12 after receiving guselkumab induction therapy and Week 44 after maintenance therapy with subcutaneous guselkumab

200mg every four weeks or 100mg every eight weeks.

At Week 12, 23 per cent [95/421] of patients treated with induction guselkumab achieved the primary endpoint of significantly greater clinical remission compared to 8 per cent [22/280] of those receiving placebo. At Week 44, 50 per cent [95/190] of patients treated with subcutaneous guselkumab 200mg and 45 per cent [85/188] of patients with 100mg achieved significantly

greater clinical remission compared to 19 per cent [36/190] in the placebo group.

Symptomatic improvements were observed as early as Week 1, and seven of nine prespecified, multiplicitycontrolled major secondary endpoints, including clinical, endoscopic, histologic, symptomatic, and patientreported outcome measures were met in the induction study, with all nine met in the maintenance study for both dose regimens.

Across the QUASAR programme, safety results were consistent with the known safety profile of guselkumab in its approved indications. Additionally, in the QUASAR phase 3 maintenance study, substantive rates of objective measures of disease remission, including endoscopic and histologic remission, were observed. These are linked to complete mucosal healing and improved long-term outcomes for patients who achieve these histologic and endoscopic endpoints.

The efficacy of guselkumab was demonstrated in both biologic and JAK inhibitornaïve patients and in patients with a history of inadequate response or intolerance to biologics and/or JAK inhibitors.

In conjunction with the demonstrated safety profile, these data suggest that guselkumab has the potential to be a compelling treatment option for both subpopulations.

Guselkumab is not currently approved for the treatment of ulcerative colitis.

Teriflunomide Clonmel Clonmel Healthcare is delighted to announce the launch of Teriflunomide Clonmel 14mg film-coated tablets.

Teriflunomide Clonmel is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS).

Full prescribing information is

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available on request or alternatively please go to www.clonmel-health. ie. Medicinal product subject to restricted medical prescription.

Please contact Clonmel Healthcare on 01-6204000 if you require any additional information.

Date prepared: December 2024.

2024/ADV/TER/285H

VOL 26 ISSUE 2 : FEBRUARY 2025

AVAIL ABLE IN PRINT AND DIGITAL

WWW.IRISHPHARMACIST.IE

The speed of soluble pain relief With a LEMON FLAVOUR

Panadol Actifast Lemon 500mg Soluble Tablets (paracetamol) •

Can start to relieve pain from 15 minutes

•

Dissolves in water to create a lemon-flavour solution

•

An alternative for patients who don’t like the taste of unflavoured soluble tablets Paracetamol

Product Information: Please consult the summary of product characteristics for full product information.

Panadol Actifast Lemon 500 mg Soluble Tablets (paracetamol) Indications: Short-term management of symptoms of headaches, musculoskeletal disorders, menstrual pain, toothache, colds and flu, as well as symptomatic relief of mild to moderate pain associated with doctor-diagnosed osteoarthritis. Dosage: Adults (including the elderly) and children 16 years and over: 1-2 tablets up to 4 times daily, as required. Children aged 10-15 years: 1 tablet up to 4 times daily, as required. Max 4 doses in 24 hours. Do not give to children for more than 3 days without consulting a doctor. Do not give to children under 10 years. Minimum dosing interval: 4 hours. Contraindications: Hypersensitivity to paracetamol or any of the other ingredients. Precautions: Do not use with any other paracetamol-containing products. Use with caution in patients with glutathione depleted states, those with risk factors for hepatotoxicity (see SPC for list). Caution, due to paracetamol, if administered with flucloxacillin due to increased risk of high anion gap metabolic acidosis. Contains: 427 mg sodium per tablet, use with caution in those on a low sodium diet. 50 mg sorbitol per tablet Patients with hereditary fructose intolerance should not take this medicinal product. Side effects: All very rare: Thrombocytopaenia, hypersensitivity reactions including anaphylaxis, skin rash, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, serious skin reactions, bronchospasm, hepatic dysfunction. MA Holder: Haleon Ireland Limited, 12 Riverwalk, CityWest Business Campus, Dublin 24. MA Number: PA 678/39/17. Legal Category: Pharmacy Only. Text revised: January 2024. Further information available on request.

Contains Paracetamol. Always read the label/leaflet.

Trade marks are owned by or licensed to the Haleon group of companies. PM-IE-PAN-24-00008