IPN March 2025 by IPN Communications LTD

a physician. Patients should be advised to contact their healthcare professional before use. Recommended Dose for Adults with Renal Impairment:

Hepatic impairment: In patients with hepatic impairment or Gilbert’s Syndrome, the dose should be reduced or the dosing interval prolonged. Patients should be advised to contact their healthcare professional before use. The Elderly: Experience has indicated that normal adult dosage is usually appropriate. However, in frail, immobile, elderly subjects or in elderly patients with renal or hepatic impairment, a reduction in the amount or frequency of dosing may be appropriate. For certain patient groups, a reduced maximum daily dose should be considered: Patients who are underweight (for adults, those under 50kg), Chronic alcoholism, Dehydration, Chronic malnutrition. These patients should be advised to contact their healthcare professional before use. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Paracetamol should be administered with caution under the following circumstances: Hepatic impairment, Chronic alcoholism, Renal impairment (GFR≤50ml/min), Gilbert’s Syndrome (familial non-haemolytic jaundice), Concomitant treatment with medicinal products affecting hepatic function, Glucose-6-phosphate dehydrogenase deficiency, Haemolytic anaemia, Glutathione deficiency, Dehydration, Chronic malnutrition, Patients who are underweight (for adults, those under 50 kg), Elderly. In general, medicinal products containing paracetamol should be taken for only a few days without the advice of a physician or dentist and not at high doses. If high fever or signs of secondary infection occur or if symptoms persist for longer than 3 days, a physician should be consulted. Prolonged or frequent use is discouraged. Patients should be advised not to take other paracetamol containing products concurrently. Taking multiple daily doses in one administration can severely damage the liver; in such cases medical assistance should be sought immediately. Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported very rarely in patients receiving paracetamol. Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism)who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors. Calpol Infant Sugar Free: Carmoisine (E122) which may cause allergic reactions.-Methyl parahydroxybenzoate (E218),Propyl parahydroxybenzoate (E216), Ethyl parahydroxybenzoate (E214) which may cause allergic reactions (possibly delayed).This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium-free’. This medicine contains 14.32mg propylene glycol (E1520) in each 5ml dose, which is equivalent to 2.86mg/ml. This medicine contains 0.16mg benzyl alcohol in each tablet. High volumes should be used with caution and only if necessary, especially in subjects who are pregnant or breastfeeding, or subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).This medicine contains 0.00071mg of alcohol (ethanol) in each 5ml which is equivalent to 0.000142 mg/ml. The amount in 5 ml is equivalent to less than 1ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. Due to the sorbitol (E420) and maltitol (E965) content of this product, patients with rare hereditary problems of fructose intolerance should not take this medicine. Sorbitol and maltitol may cause gastrointestinal discomfort and have a mild laxative effect. Calorific value 2.3kcal/g maltitol. Calpol Six Plus Sugar/Colour Free: Contains 2.04g Maltitol and 1.4g

Sorbitol per 5ml.Sorbitol and maltitol may cause gastrointestinal discomfort and have a mild laxative effect. Patients with hereditary problems of fructose intolerance (HFI) should not take/be given this medicine. Calorific value 2.3kcal/g maltitol. Methyl and propyl parahydroxybenzoates may cause allergic reactions (possibly delayed). This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium-free’. This medicine contains 20.92mg propylene glycol (E1520) in each 5ml dose, which is equivalent to 4.18mg/ml. This medicine contains 0.05mg benzyl alcohol in each tablet. High volumes should be used with caution and only if necessary, especially in subjects who are pregnant or breastfeeding, or subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis). This medicine contains 0.00075mg of alcohol (ethanol) in each 5ml which is equivalent to 0.00015 mg/ml. The amount in 5 ml is equivalent to less than 1ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. Undesirable effects: Blood and lymphatic system disorders Not known Thrombocytopenic purpura Haemolytic anaemia Agranulocytosis Immune system disorders

Paracetamol

Generic Product Launch

Fluticasone Furoate Teva

27.5 micrograms/spray

Nasal Spray, Suspension

fluticasone furoate

Indications

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

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

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

Fluticasone Furoate Teva Nasal Spray Abbreviated Prescribing Information.

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

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

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.

Page 5: Minister for Health meets with IPU

Page 6: PHX Ireland: Shaping the Future of Healthcare

Page 8: IPHA publishes position paper on the 2025 Programme for Government Commitments

Page 10: Pharmacy Reforms Needed says Latest Study

Page 12: Over ¤700,000 needlessly spent on communications to healthcare professionals

Page 18: Gut Health in Babies and Children

Page 47: Launch of the 2025 Irish Pharmacy Awards

Page 72: Immune Cell ‘Memories’ – Increasing Risk of Blood Clots

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Ireland Ltd.

Clifton House, Fitzwilliam Street Lower, Dublin 2 00353 (01) 6690562

MANAGING DIRECTOR

Natalie Maginnis n-maginnis@btconnect.com

EDITOR

Kelly Jo Eastwood: 00353 (87)737 6308 kelly-jo@ipn.ie

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Amy Evans | amy@ipn.ie 0872799317

EDITORIAL/ EVENTS & MARKETING EXECUTIVE

Aoife Hunter: aoife@ipn.ie

CONTRIBUTORS

Colm Moore | Ciara O’Byrne

Foreword

In one of our lead news stories this month, we detail, how the Minister for Health, Jennifer Carroll MacNeill recently met with representatives from the Irish Pharmacy Union in an effort to resolve the confusion and frustration around the HRT scheme.

“I met the IPU on 11 February and have been engaging with it since then. Pharmacies could have a much greater and expanded role in healthcare in terms of diagnostics, prescriptions and common conditions. I am really excited about the opportunity for pharmacy and I met the IPU about this.

“There is a huge body of work to do to support pharmacists a little more than we have been - there is no question about thatto go further in our ambition on what pharmacy can do, as well as to resolve this. In fairness, this is the first time the question of a dispensing fee has come up,” she said. You can read more about this on page 5.

In other news on page 8, the Irish Pharmaceutical Healthcare Association (IPHA) has published a position paper on the 2025 Programme for Government Commitments which makes the case for Faster and Fairer Access to Medicines.

This paper, which for the first time measures access to medicines timelines against the Health Act 2013, finds that patients in Ireland continue to wait almost two years to access new lifeenhancing medicines. In welcoming commitments by the new Government, IPHA offers a way forward to reform the system and provide patients with the care they deserve.

A new study, detailed on page 10 reveals the need for health system reforms to further integrate the community pharmacy sector are required to strengthen Ireland’s pandemic preparedness. Legislative changes to expand pharmacists’ roles, particularly during public health emergencies, are among the recommendations outlined in the new research.

Lisa McAnena | Morgan Reid

Dr Kevin McCarroll | Dr Lucia Braz

Dr Werd Al-Najim | Katie Mugan

Tomas Conefrey | Niamh Vickers

Dr Donal Fitzpatrick

Dr Christopher Shannon

Denise McGuinness

Dr Deirdre O’Donovan

Professor Richard Conway

DESIGN DIRECTOR

Ian Stoddart Design

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

Our Baby and Children Special Focus section contains a range of clinically contributed articles around areas such as gut health and nutrition in this sector while on page 47 we launch the 2025 Irish Pharmacy Awards.

The Awards take place this year on Saturday 24th May and we have some fantastic Categories, as well as some new additions to the line-up. Now is the time to recognise dedication. The Irish Pharmacy Awards 2025 will be a celebration of success and also a platform of gratitude to community pharmacists and their teams. The awards recognise excellence and innovation and this is the premier opportunity for the industry to show their appreciation.

Grab your entry form today!

New Digital Tool to Monitor Prescribing Trends

A new digital tool, developed by researchers at RCSI University of Medicine and Health Sciences, will provide real-time insights into prescribing trends in Ireland. The interactive platform, known as RxTrends, enables healthcare professionals, policymakers and researchers to analyse national prescribing patterns, offering a valuable resource for decision-making and policy development.

The RxTrends application is the first of-its-kind in Ireland, using publicly available data from the Health Service Executive’s (HSE) Primary Care Reimbursement Service (PCRS). It allows users to visualise and compare prescribing rates and costs for medications and therapeutic groups over time, giving a clearer picture of medicine usage across the country.

“Understanding how medicines are prescribed and how costs evolve over time is crucial for improving healthcare policy and practice,” said Professor Frank Moriarty, Associate Professor at RCSI’s School of Pharmacy and

Professor Frank Moriarty

Biomolecular Sciences who led on the development of the application. “RxTrends provides a user-friendly way to analyse prescribing data, which can help us to ensure more efficient use of medicines, to understand how prescribing aligns with national recommendations, how generic medicines can save costs for the health service and the impact of new policies.”

The application was developed by Professor Moriarty and Dr Ahmed Hassan Ali, Postdoctoral Researcher at RCSI School of Pharmacy and Biomolecular Sciences, using the R-based Shiny framework and incorporates prescribing and cost data from 2016 to the most recent available data, covering the 100 most frequently prescribed medicines and all therapeutic groups. Users can track trends by selecting specific medicines or broader therapeutic categories, making the tool highly flexible and informative.

Key functionality of the tool includes:

• Graphs and trend analyses of medication use and costs over time.

PMI Pharma Summit 2025

• Download data for the time frame and medications of interest.

• The ability to assess the proportion of prescribing for a medication within therapeutic groups.

• Using the data to explore how medication use changes based on seasonal trends or policies like Ireland’s Preferred Drug Initiative and the introduction of generic medicines.

While RxTrends represents an important step forward in monitoring medication use in Ireland, researchers emphasise that further improvements could be made with access to more detailed prescribing data.

The development of RxTrends was part of the CDRx project funded by the Health Research Board and developed with collaborators in University College Cork and the Health Service Executive (HSE). The approach for developing the tool has been documented in a newly published paper detailing its methodology and potential applications.

For more information on RxTrends, visit www.cdrx-project.eu.

The Pharmaceutical Managers’ Institute Annual Pharma Summit takes place on Thursday 3rd April, 2025 in the Croke Park conference centre.

The theme for the day is: “Evolving Through Change,” and will explore this topic across industry changes, stakeholder changes and the changes in pharmacy and primary care. This flagship event will bring together a wide range of attendees, including industry leaders, subject matter experts, and thought leaders.

Speakers will include Professor Kingston Mills – Professor of Experimental Immunology and Director of Trinity Biomedical Sciences Institute at Trinity College Dublin, Fionnuala King – Chief Pharmacist at HSE and Sarah Rickwood – Vice President, EMEA Thought Leadership at IQVIA. Visit www.thepmi.com for more information.

HSE Health App

The Department of Health and HSE launched the first version of the HSE Health App. It is one of the first initiatives delivered as part of Digital for Care, Ireland’s health and social care digital framework. From today anyone aged 16 and over can download the app for free from Google Play or the App Store, however first phase functionality will be most useful for expectant mothers.

First phase functionality allows people to:

• carry a digital list of selfdeclared medications and see a list of medicines received through the Drugs Payment Scheme or Medical Card Scheme

• store your European Health Insurance Card (EHIC), medical card, Long-term Illness card (LTI), Drugs Payment Scheme card (DPS) and GP Visit card

• access flu and COVID-19 vaccination records

• easily find information about HSE services, such as EDs and Injury Units

• view maternity service appointments (for expectant mothers)

Minister for Health, Jennifer Carroll MacNeill TD, said, “This App is an exciting milestone where we begin to give patients digital access to their own health information and will make it easier for everyone to navigate the health service.

“We can now ensure that every patient is provided with easily accessible health information that is accurate and trustworthy. The phased introduction of appointment notifications and reminders will make it easier for people to manage their care.

“I know the App development team have also consulted with a number of patient organisations so that their needs are incorporated into the design process to ensure the App is patient-centred.” Work is underway to make public hospital appointment notifications and reminders, and support to quit smoking, available in the app.

Role of Pharmacy in Falsified Medicines

Pharmacists in both community and hospital settings are wellpositioned to swiftly detect substandard and falsified (SF) medical products in supply chains, report them to the authorities, and educate and advise affected patients, FIP told the World Health Organisation (WHO) Executive Board in Geneva, Switzerland.

Speaking on behalf of FIP during the agenda item on SF, Tjaša Škerl Rifelj, from the International Pharmaceutical Students' Federation, welcomed the WHO Member State mechanism’s efforts to address SF medical products and facilitate collaboration among stakeholders. In the statement, FIP highlighted its collaboration with WHO as proof of the critical role pharmacists play in detecting and reporting SF products, underscoring the importance of their involvement in tackling this issue, as well as the positive outcomes resulting from this partnership.

Substandard and falsified (SF) medical products as defined by the World Health Organization, are major threats to public health. Through increasing globalisation, the problem has expanded in both developed and developing countries.

Pharmacists are key to combatting SF medical products because they are healthcare professionals with direct access to patients. Pharmacists are the gatekeeper for appropriate medication management. Pharmacists are not only necessary to ensure supply of medicines in a proper and just manner, but they also check for unauthorised sales of medicines or medical products that are not of certified quality. As the final member of the pharmaceutical distribution chain as well as often being supply chain managers, pharmacists are crucial in preventing introduction of SF medical products into the supply chain and in promoting adherence to good distribution practices.

During the Executive Board, FIP is also taking part in joint statements on the health and care workforce, climate change, and health emergencies with the World Health Professions Alliance (WHPA) and members of the Health Stakeholder Network (HSN).

Minister for Health Jennifer Carroll MacNeill has recently met with representatives from the Irish Pharmacy Union regarding the delay in rolling out a new national plan which aims to create free access to HRT to all women in Ireland. The meeting was an attempt to resolve the delay and bring clarity to confusion.

Speaking on International Women’s Day recently in the Dail, the Minister said, “There are two primary issues with HRT. The first is the shortages involved. There is a certain amount we can do, and then there is the reality as well. The issue is not access …The issue is demand, the growing demand across Europe and the manufacturer’s ability to produce it quickly enough to meet demand, not just here but across the Continent.

“Strictly speaking, the Government cannot override that shortage of supply. We can do everything we can to try, but, ultimately, we are suffering in the same way as the rest of Europe is in respect of the availability of certain medications and how that changes over time.

“The second piece, correctly, relates to the cost of HRT. It is important to distinguish something. The former Minister, Stephen Donnelly, secured ¤20 million funding to cover the cost

Body of Work to ‘Support Pharmacists’ Medicines for Ireland announces Expansion

of the HRT products. That did not include - Senator Tully inquired about this - a GP scheme, nor did it include funding to cover pharmacists' dispensing fees. Those are different. The State has not done that before. I refer to these incremental initial steps. I think the former Minister wanted to pay for the medication as a contribution to reduce the cost. This scheme has been available for implementation since 1 January to cover the cost of medication, not the dispensing fee. It is the first time this has happened but there was a reluctance to implement it.

little more than we have beenthere is no question about that - to go further in our ambition on what pharmacy can do, as well as to resolve this. In fairness, this is the first time the question of a dispensing fee has come up.”

Medicines for Ireland (MFI) has announced the addition of two new members, Kora Healthcare and Athlone Pharmaceuticals. This expansion reinforces MFI’s commitment to strengthening the industry voice and delivering on its mission to champion sustainable healthcare solutions and advocate for policies prioritising patient access and affordability.

This is a significant year for the industry as it prepares for the review of the agreement setting out the pricing and supply arrangements for generic, biosimilar, and value-added medicines. MFI is finalising preparations to enter negotiations with the State on the new Framework Agreement where it will advocate for policies that support early market access, invest in the sustainability of low-cost medicines, encourage switching to biosimilars, and recognise the financial and human benefits of value-added medicines

Commenting on the expansion, Chair of Medicines for Ireland, Paul Neill said: “We are delighted to welcome Kora Healthcare and Athlone Pharmaceuticals as members of Medicines for Ireland. Both companies have a wealth of expertise that will assist the association as we prepare to enter negotiations on a new Framework

Agreement with the State. Our goal is to strengthen the agreement to minimise medicine shortages impacting Irish patients while delivering millions in savings for the State.”

Welcoming MFI’s membership approval, Commercial Director ROI & ROW at Kora Healthcare, Shane Fitzgearld said: “We are proud to join Medicines for Ireland and stand alongside our peers in advancing the availability of affordable medicines in Ireland through new policies that will safeguard supply. Through collaboration with the State, we can continue to drive advancements that ensure patients have access to the medicines they need when they need them.”

Head of Athlone Pharmaceuticals Limited, Barry Doyle said: “Joining Medicines for Ireland is a significant milestone for Athlone Pharmaceuticals. We look forward to contributing to the association’s

efforts to make affordable medicines accessible to patients in Ireland. As an MFI member, we will advocate for policies that bolster manufacturing in Europe and call for regulations to be viewed through the lens of securing supply for patients.”

Vice Chair of MFI, Deirdre Kelly said, “The expertise both companies bring will be invaluable as we continue to champion policies that prioritise patient access, affordability, and sustainability across the pharmaceutical sector and wider healthcare system.”

Medicines for Ireland members unanimously approved the applications from KORA Healthcare and Athlone Pharmaceuticals at its February meeting. Their expertise will be crucial as the association enters pivotal negotiations to shape the future of medicine pricing and supply in Ireland.

Minister for Health, Jennifer Carroll MacNeill

PHX Ireland: Shaping the Future of Healthcare with Purpose, Vision,

and

People at the Core

PHX Ireland Group Limited was established in 2023 when it was rebranded from McKesson Ireland and has rapidly evolved, becoming a beacon of innovation and excellence in the Irish healthcare landscape. As the parent company of United Drug, TCP Homecare, and McCabes Pharmacy, PHX Ireland has demonstrated a commitment to enhancing healthcare delivery across the nation. Today, we are proud to share the next chapter in our journey, marked by a renewed purpose, a clear vision, and a steadfast mission that places people at the heart of everything we do.

A Purpose That Makes a Difference

At PHX Ireland, our purpose is at the heart of everything we do: We make a real, lasting difference This guiding principle reflects our dedication to impacting lives positively—from our patients and colleagues to our customers and the broader communities we serve. It is through this lens that we evaluate every decision, ensuring that our actions empower, support, and bring meaningful change across Ireland.

Our Mission: Delivering Health Through Innovation

Our mission, We deliver health, encapsulates our role as a leader in the healthcare sector. By harnessing cutting-edge technology and driving operational efficiencies, we develop and deliver tailored products and

services that make exceptional healthcare accessible to everyone through our supply chain, retain pharmacy and community nursing businesses. This mission is not just a statement; it is a call to action that inspires us to push boundaries and redefine what is possible in healthcare delivery.

A Vision for Healthier Futures

Looking ahead, our vision is ambitious and inspiring: We create healthier futures for everyone. As Ireland's leading wholesaler under United Drug, largest community pharmacy brand under McCabes Pharmacy, and healthcare service provider with TCP Homecare, we are committed to setting new standards of excellence. Our goal is to drive transformative change, raise the bar in healthcare services, and foster stronger, healthier communities nationwide.

Introducing the New PHX Ireland Website

In alignment with our evolved brand identity, we are excited to announce the launch of the new PHX Ireland website. This dynamic platform is more than just a digital presence; it is a reflection of our values, showcasing who we are, what we stand for, and the impact we aim to achieve. The website offers a comprehensive overview of our operations, insights into our corporate culture, and a userfriendly job application system designed to attract and engage top talent in the healthcare sector.

Our new online platform is a testament to our commitment to transparency, accessibility, and continuous improvement. Whether you are a healthcare professional seeking opportunities, a partner looking to collaborate, or a customer wanting to learn

Recruiting for 5th-Year Placements NOW!

APPEL (Affiliation for Pharmacy Practice Experiential Learning) is now seeking expressions of interest from pharmacists in community and hospital pharmacy settings who would like to facilitate an experiential learning placement for a final-year pharmacy student in 2026.

If you would like to offer a placement, please email ops@appel.ie now!

In the 5th-year of their M.Pharm programme, students solidify their learning by completing an eightmonth placement in a patientfacing setting before becoming eligible to sit the Professional Registration Examination (PRE) and enter the PSI register. The advantages of facilitating an APPEL placement include:

• Development of your talent pipeline – many students will look to start their career in the organisations where they undertook their placements.

• Continuing Professional Development – Facilitating an APPEL placement provides numerous opportunities for professional development.

• Engagement – participating in the APPEL programme provides you with the opportunity to increase awareness of your pharmacy/organisation among present and future pharmacists.

The next 5th-year placements will run from the 5th of January to the 28th of August 2026. You can confirm your interest in offering a placement by emailing APPEL at ops@appel.ie.

more about our services, the PHX Ireland website is your gateway to discovering how we make a difference every day.

People-Centric, Purpose-Driven

At PHX Ireland, our evolution is fuelled by a deep-seated belief that people are the cornerstone of healthcare. Our renewed purpose, mission, and vision are the foundation of a culture that values care, innovation, and excellence. As we continue to grow and adapt in an ever-changing healthcare environment, we remain unwavering in our commitment to delivering health.

Explore our new website, connect with our team, and discover how PHX Ireland is making a real, lasting difference in healthcare across Ireland. Follow our LinkedIn channel for updates on our progress, our teams and industry news.

As Ireland’s leading healthcare provider, PHX Ireland places people at the heart of everything we do. From supply chain to retail pharmacy through to clinical home nursing, our goal is to make a real, lasting di erence to our patients and communities health across Ireland.

Discover our values, explore career opportunities, and see how we’re shaping the future of healthcare at www.phxireland.ie

Faster and Fairer Access to Medicines

The Irish Pharmaceutical Healthcare Association (IPHA) has published a position paper on the 2025 Programme for Government Commitments which makes the case for Faster and Fairer Access to Medicines

“We now have an opportunity, together, to effectively reform the system and meet the goal of faster and fairer access to new medicines for patients in Ireland”

This paper, which for the firsttime measures access to medicines timelines against the Health Act 2013, finds that patients in Ireland continue to wait almost two years to access new life-enhancing medicines. In welcoming commitments by the new Government, IPHA offers a way forward to reform the system and provide patients with the care they deserve.

The Programme for Government states the Government is committed to ensuring that patients have access to new medicines ‘as quickly as possible.’ Faster and fairer access is essential because patients in Ireland are currently not getting the

same treatment that is available in other countries or indeed available to private patients here in Ireland. Clinicians often find themselves in the difficult position of not yet being able to prescribe a new medicine which they know could improve the healthcare outcomes for their patient.

According to the IPHA findings, of the 88 IPHA medicines reimbursed from 2022-2024:

• 617 days was the average reimbursement time from medicine application in the Irish system to patient access.

• For the 45 IPHA cancer medicines reimbursed during

IPHA Chief Executive Oliver O’Connor and President Shane Ryan welcome Minister for Health Jennifer Carroll MacNeill to the IPHA Annual Conference

these three years, the average time before a patient could access the treatment was 694 days.

• Over this period, there were 17 IPHA orphan medicines reimbursed which took 655 days to patient access.

• On average it took 916 days for 44 IPHA medicines needing a full Health Technology Assessment (HTA) to be available to patients in Ireland, for which state processes accounted for approximately 65% of the time or 593 days.

• Of the 88 IPHA medicines reimbursed, it took on average five months from the final price offer being proposed by a company to the State before the medicine reached the patient.

• 86% of medicines reimbursed during the three-year period were in excess of the 180-day timeline outlined in the Health Act 2013.

Based on these figures, it is clear that the reimbursement system needs to be resourced, governed and designed to operate within the legal 180-days timeline set by the Oireachtas in 2013. Operating within this timeframe will speed up access for patients by a year or more. IPHA are not calling for

a change to the law but rather reform of the system to ensure all parties involved adhere to the legislation. This can be achieved by incorporating and adopting Five Key Principles of mutual commitments in the Framework Agreement, due for negotiation in 2025.

Collectively, pharmaceutical companies and the HSE, along with Government support, can create a system that delivers fairer and faster access to new medicines, within the Health Act 2013, and provide patients in Ireland with timely access, ‘as quickly as possible’, to the treatment they need.

Speaking ahead of their Annual Conference in Dublin last month, Oliver O’Connor IPHA Chief Executive said, “A year can make a big difference in a patient’s life. In the normal course of events, if the Irish system adhered to the legislation, patients in Ireland could access new medicines within a year rather than, on average, nearly two years after an application for reimbursement, and longer for many cancer and rare disease medicines.

“We now have an opportunity, together, to effectively reform the system and meet the goal of faster and fairer access to new medicines for patients in Ireland.

“We welcome positive steps introduced in recent years by the Minister for Health such as the use of ‘indicative timelines’ by the HSE. The Programme for Government commitments to review the medicines reimbursement process and to implement the Mazars Review recommendations further builds upon this recognition that patients in Ireland deserve better.

“A new Framework Agreement on the pricing and supply of medicines between IPHA and the State is due to be negotiated in 2025. IPHA is proposing Five Key Principles of mutual commitments to be included in the Framework Agreement. If adopted, these Principles will improve patient care, allow for more productive partnerships, improve health system functioning and will fulfil the commitments in the Programme for Government for quicker access to new innovative medicines.”

Pharmacy Reforms Needed says Latest Study

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

Legislative changes to expand pharmacists’ roles, particularly during public health emergencies, are among the recommendations outlined in the new research published in the journal Qualitative Health Research.

The researchers also called for improved IT integration between pharmacies and the health system to facilitate the sharing of patient records.

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

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

“However, unlike some other high-income countries, community pharmacies in Ireland were involved relatively late in the COVID-19 vaccination programme – four months after GPs were engaged. This delay was even more puzzling since community pharmacies in Ireland had been providing various vaccination services for almost a decade, including the annual flu vaccine.

Aaron Koay

Strategic Direction

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

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

The research highlights a lack of strategic pharmacy leadership in Ireland citing, ‘In Ireland, the lack of central, strategic, and cohesive leadership has impeded the role advancement of pharmacy: “Pharmacy has shot itself in the foot” (IIOP_1).

‘First, most elites agreed that the lack of a central pharmacy voice in the DoH and HSE may have impeded the efficient roll-out of CP-based COVID-19 vaccination. Notably, no pharmacy stakeholder was present on the High-level Task Force on COVID-19 Vaccination (DoH, 2020). Further, the Chief Pharmacy Officer post in the DoH has been vacant since 2013 (Lynch, 2014), in contrast with neighbouring jurisdictions like the United Kingdom (where each of the four countries has such an officer). Evidence also shows that the previous lack of senior dentistry representation at the DoH and HSE has resulted in “political disinterest” in oral health policies in Ireland (McAuliffe et al., 2022, p. 8).

‘Thus, without senior pharmacy leadership, it is possible that “there

will never be the vision to properly integrate pharmacy services into the healthcare system” (IPU_3).

‘Nonetheless, some nonpharmacist elites were unsure about the role a Chief Pharmacist Officer in the DoH or HSE would play in public health (POL_1; IMO_1): “It’s not about divvying up the cake” (IMO_1). In July 2022, the Minister for Health Stephen Donnelly also mentioned that the DoH did not have plans to appoint such an officer (Houses of the Oireachtas, 2022), as there were already qualified pharmacists working in his office. Further, it was maintained that a previous proposal to have pharmacy subsumed under the representation of Health and Social Care Professionals in the HSE was met with pharmacy opposition due to a preference for a specific pharmacy officer (IIOP_1). However, the profession has not been able to campaign for one successfully.

‘Second, the pharmacy profession in Ireland does not have a professional leadership body (O’Sullivan & McCarthy, 2022) that can promote the role of CPs for the public good without (perceived) undue commercial influence.

The PSI serves as the pharmacy regulator that safeguards the public’s interests, while the IPU operates as a trade association representing the business and professional interests of CPs.

Professional Leadership

‘There is currently no independent body dedicated to the professional interests of CPs to enhance patient care (although the Irish Institute for Pharmacy, at the behest of the PSI, manages the Continuous Professional Development of the profession with limited autonomy and resources). This contrasts with some other health professions, such as general practitioners, where their professional interests are represented by the Irish College of General Practitioners and their trade interest (and some professional interests) by the Irish Medical Organisation (IMO), while regulation is overseen by the Medicine Council of Ireland. Due to increased commercialism and competition, policymakers may further perceive an erosion in the professionalism of pharmacists (Bradley, 2009; Traulsen & Almarsdóttir, 2005). For instance,

the Health (Community Pharmacy Contract Agreement) Regulations to control the density of CPs were revoked in 2002 due to legal cases brought forward by some CPs, creating a pro-competitive sector (Purcell, 2004).

‘Third, the refusal of the IPU to be part of the primary care team structure proposed in the 2001 “Primary Care: A New Direction” strategy (DoH, 2001)—based on concerns about the potential loss of professional autonomy and that some CPs would financially benefit from co-location with GPs due to increased footfall (Bradley, 2009; Henman, 2020)—was perceived to have diminished the

role of CPs in primary care. It was suggested that this may have had implications for the influence of CPs in the policy space.’

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

The missed opportunity to engage community pharmacies earlier in providing COVID-19 vaccination to save lives should be part of the evaluation, advise the authors. While the Irish Government has recently committed to expanding the role of pharmacists in Ireland, the authors also cautioned against complacency because, as this research reveals, policy implementation can be obstructed or delayed.

Dr Camilla Devitt, Associate Professor in Sociology, in the School of Social Sciences and Philosophy, added, “Our

research is the first of its kind in the pharmacy practice sphere in Ireland. Through interviewing key policy elites and reviewing extensive documentary sources, we found that the implementation of community pharmacy-based COVID-19 vaccination in Ireland was far more than a technical exercise – it was a highly political process that involved several stakeholders and interests.

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

Said the research authors, “Future viral epidemics and pandemics are inevitable (Morse et al., 2012; Telenti et al., 2021), and health system actors must “partner, coordinate, develop, and strengthen” (Haldane et al.,

2021, p. 1) intersectoral pandemic vaccination planning and response to ensure efficient and equitable vaccine access. With regard to improving pandemic preparedness in Ireland, based on our analysis, we recommend that:

1) The legislative and regulatory framework governing the scope of pharmacists’ (vaccination) practice should undergo review to enhance flexibility especially during periods of public health crises;

2) The integration of IT infrastructure between CPs and the broader health system, particularly concerning electronic patient records, should be further developed; and

3) The different pharmacy bodies collectively develop a cohesive leadership vision and engagement strategy, including continued advocacy for senior representation like Chief Pharmacy Officers in the

DoH and HSE, to advance pharmacy practice in the public’s best interest.

“We believe that it would be fruitful to extend this case study to a comparative analysis with countries where CP involvement in COVID-19 vaccination also experienced delays—such as Australia where operational challenges are evident (Jackson & Al-Wassiti, 2021; Walliar et al., 2023)—as well as countries where CPs were swiftly engaged—such as the United Kingdom (Wickware, 2021)—to develop cross-case insights with wider applicability (Gilson et al., 2011).

“Given the complex policy dynamics between ideas, interests, and institutions that shape the landscape of CPs in Ireland, having a deeper grasp of health politics would better equip the profession to advocate for better health policy (Buse, 2008). While our work has shed some light on some of these dynamics, we hope it will inspire future work in this area.”

Urgent Call for Digital-First Communications

Over ¤700,000 needlessly spent on communications to healthcare professionals

Medicines for Ireland (MFI) has highlighted the urgent need for transition to digital-first communication with healthcare professionals to reduce inefficiencies, environmental impact, and rising costs. Under the current paper-based system, pharmaceutical manufacturers are mandated to print and distribute safety information separately, even when multiple companies are providing the same information for the same medicine.

This is resulting in thousands of printed materials being sent to healthcare professionals, much of which is redundant. Data provided by 75% of MFI members, shows they were required to print over 1.2 million pages or 6.3 metric tonnes of safety communications in the past three years. The cost of which amounted to more than ¤700,000 to print, store and distribute.

Chair of Medicines for Ireland, Paul Neill emphasised the scale of waste caused by the current system ahead of MFI’s ‘Digital solutions for a greener industry’ event this morning.

Commenting, Mr Neill said: “Very often when a generic or biosimilar medicine is launched, multiple pharmaceutical companies are required to send the same printed safety communication to the same healthcare professionals. The only differentiating factor is the logo at the top of the page. This duplication is inefficient, environmentally damaging, and unnecessary in an era where digital alternatives are available.

“There is a real opportunity to drive innovation within

the Irish healthcare system through enhanced use of digital communications. This is being realised is other European countries like the Netherlands where the policy for sending direct healthcare professional communications (DHPC) and recall letters has shifted towards digital. The Dutch hybrid system allows for important risk communications to be delivered quickly via email to healthcare providers, while those without a registered email address continue to receive them by post. The Swedish Medicines Agency has also introduced a similar pilot study where important drug information is sent to the digital mailboxes of concerned prescribers.

“Without a clear pathway to digital communications between industry and healthcare professionals in Ireland, we risk falling behind in our ability to communicate critical safety information efficiently and effectively. As a first step we must consider how the advancements and learnings from our European neighbours can be replicated, complementing the ambition around digital connectivity across

Chair of Medicines for Ireland, Paul Neill with Vice-Chair Deirdre Kelly and Dr Pat O’Mahony, Chairman, Health Information and Quality Authority /Chair, Irish Medicines Verification Organisation

HPV, Smoking and Cervical Cancer

Marking HPV Awareness Day (4 March 2025), the HSE has announced a new initiative to support patients and healthcare professionals to understand the links between smoking, HPV and cervical cancer. Smoking increases the risk of having an active HPV infection which can lead to harmful health outcomes such as cell abnormalities in the cervix and cervical cancer.

the wider Irish healthcare system,” Mr Neill added.

MFI’s ‘Digital solutions for a greener industry’ event brings together experts and representatives from across the healthcare sector to explore the benefits, opportunities, and challenges of transitioning to a digital-first model. Hosted in the Royal Irish Academy, Dublin 2, attendees will hear perspectives from the Irish Pharmaceutical Union (IPU), and the Health Products Regulatory Authority (HPRA).

Highlighting the advantages, Vice Chair of Medicines for Ireland, Deirdre Kelly said: “The way we communicate has changed dramatically, particularly since the pandemic, yet our sector remains heavily reliant on out-dated systems that have not kept pace with technological advancements. Other European countries have successfully adopted digital-first safety communications without compromising patient safety. Ireland must modernise its approach to align with best practices and reduce unnecessary waste.”

“There are many examples of advancements in utilising the use of technology within the Irish health sector in recent years. We have recently seen the launch of the HSE patient app and a successful pilot of electronic health records for patients with a commitment to introduce EHRs across the system in the Digital Health Strategy. All of these are to be welcomed and commended. Our members are very much committed to working in partnership with all stakeholders involved to ensure a pathway to achieving the benefits of digital-first communications between industry and healthcare professionals are found.”

Through this initiative, resources and supports are being provided to women who are referred to colposcopy clinics through CervicalCheck and who are smokers. The project aims to support women who smoke so they can better understand the relationship between smoking, HPV and cervical cancer, and the benefits of quitting smoking. In addition, the HSE QUIT team is putting in place e-referrals from colposcopy clinics, so that clinics can easily refer their patients to quit smoking services.

According to Professor Nóirín Russell, CervicalCheck Clinical Director, HSE National Screening Service, “We know that smoking is a risk factor for persistent HPV – that is HPV that your body cannot clear, which can lead to cell abnormalities in the cervix and cervical cancer.

“About 4 in 10 women who attend colposcopy clinics in Ireland are smokers, and we want to support our colposcopy clinics to have conversations with women about smoking, and the link between HPV and cervical cancer.

“Colposcopy is a vital part of the CervicalCheck programme and colposcopy clinics are a suitable setting for brief interventions about smoking. Treatment of precancers is very safe and efficient and 90% of women will never need another treatment.”

This joint project involving the National Screening Service and its CervicalCheck programme, Tobacco Free Ireland, the Nurses in Colposcopy Clinics in Ireland Association, and UCC School of Public Health has created the resources that will provide information to patients in colposcopy and their healthcare providers.

ALLERGIES TAKING OVER YOUR LIFE?

Abbreviated prescribing information

Product Name: Fexo Allergy Relief 120 mg Film-coated tablets

Composition: Each tablet contains 120 mg of fexofenadine hydrochloride equivalent to 112 mg of fexofenadine. Description: Peach coloured oblong, bi-convex film-coated tablet. Dimensions of 14.9-15.3 mm x 6.4-6.8 mm; plain on both sides. Indication(s): Adults and children 12 years and older: Relief of symptoms associated with seasonal allergic rhinitis. Dosage: Adults and children aged 12 years and over: One tablet (120mg) once daily taken before a meal. Children under 12 years: Efficacy and safety of fexofenadine hydrochloride 120 mg has not been studied in children under 12. Children from 6 to 11 years of age: Administer fexofenadine hydrochloride 30 mg. Special populations: No need to adjust the dose confirmed by studies in special risk groups (older people, renally or hepatically impaired patients). Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions for Use: Limited data in the elderly and renally or hepatically impaired patients. Administer with care in these special groups. Warn patients with a history of or ongoing cardiovascular disease that, antihistamines have been associated with the adverse reactions, tachycardia and palpitations. Interactions: Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms. Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use with P-gp inhibitors or inducers can affect the exposure to fexofenadine. Co-administration with P-gp inhibitors erythromycin or ketoconazole resulted in 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly. A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted in a 30 % decrease in AUC of fexofenadine. No interaction with omeprazole. Administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids Pregnancy and Lactation: Pregnancy: Do not use unless clearly necessary No adequate data from the use of fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Breast-feeding: Not recommended. No data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers’ fexofenadine was found to cross into human breast milk. Fertility: No human data available. Ability to Drive and Use Machinery: Based on the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective tests, Fexo Allergy Relief has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks. Undesirable Effects: Nervous system disorders: Common: headache, drowsiness, dizziness. Gastrointestinal disorders: Common: nausea. General disorders and administration site conditions: Uncommon: fatigue. Refer to the SPC for other undesirable effects. Marketing Authorisation Holder: Rowa Pharmaceuticals Limited., Newtown, Bantry, Co. Cork. Marketing Authorisation Number: PA0074/096/001 Further information and SPC are available from: Rowex Ltd., Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417 E-mail: rowex@rowa-pharma.ie

Legal Category: Not Subject to medical prescription. Date of Preparation: September 2024 CCF FOR API: 26741

Composition: Each tablet contains 120 mg of fexofenadine hydrochloride equivalent to 112 oblong, bi-convex film-coated tablet. Dimensions of 14.9-15.3 mm x 6.4-6.8 mm; plain on and older: Relief of symptoms associated with seasonal allergic rhinitis. Dosage: Adults and once daily taken before a meal. Children under 12 years: Efficacy and safety of fexofenadine children under 12. Children from 6 to 11 years of age: Administer fexofenadine hydrochloride the dose confirmed by studies in special risk groups (older people, renally or hepatically Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions or hepatically impaired patients. Administer with care in these special groups. Warn patients disease that, antihistamines have been associated with the adverse reactions, tachycardia and undergo hepatic biotransformation and therefore will not interact with other medicinal products P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant the exposure to fexofenadine. Co-administration with P-gp inhibitors erythromycin or ketoconazole fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval adverse reactions compared to the medicinal products given singly. A clinical drug-drug interaction apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted interaction with omeprazole. Administration of an antacid containing aluminium and magnesium hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing Pregnancy: Do not use unless clearly necessary. No adequate data from the use of fexofenadine Limited animal studies do not indicate direct or indirect harmful effects with respect development, parturition or postnatal development. Breast-feeding: Not recommended. administering fexofenadine hydrochloride. However, when terfenadine was administered cross into human breast milk. Fertility: No human data available. Ability to Drive and Use Machinery: reported adverse reactions it is unlikely that fexofenadine hydrochloride tablets will produce objective tests, Fexo Allergy Relief has been shown to have no significant effects on central may drive or perform tasks that require concentration. However, in order to identify medicinal products, it is advisable to check the individual response before driving or performing system disorders: Common: headache, drowsiness, dizziness. Gastrointestinal disorders: Common: site conditions: Uncommon: fatigue. Refer to the SPC for other undesirable effects. Marketing Limited., Newtown, Bantry, Co. Cork. Marketing Authorisation Number: PA0074/096/001 Rowex Ltd., Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417 E-mail: rowex@rowa-pharma.ie

Composition: Each tablet contains 120 mg of fexofenadine hydrochloride equivalent to 112 mg of fexofenadine. Description: Peach coloured oblong, bi-convex film-coated tablet. Dimensions of 14.9-15.3 mm x 6.4-6.8 mm; plain on both sides. Indication(s): Adults and children 12 years and older: Relief of symptoms associated with seasonal allergic rhinitis. Dosage: Adults and children aged 12 years and over: One tablet (120mg) once daily taken before a meal. Children under 12 years: Efficacy and safety of fexofenadine hydrochloride 120 mg has not been studied in children under 12. Children from 6 to 11 years of age: Administer fexofenadine hydrochloride 30 mg. Special populations: No need to adjust the dose confirmed by studies in special risk groups (older people, renally or hepatically impaired patients). Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions for Use: Limited data in the elderly and renally or hepatically impaired patients. Administer with care in these special groups. Warn patients with a history of or ongoing cardiovascular disease that, antihistamines have been associated with the adverse reactions, tachycardia and palpitations. Interactions: Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms. Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use with P-gp inhibitors or inducers can affect the exposure to fexofenadine. Co-administration with P-gp inhibitors erythromycin or ketoconazole resulted in 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly. A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted in a 30 % decrease in AUC of fexofenadine. No interaction with omeprazole. Administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids. Pregnancy and Lactation: Pregnancy: Do not use unless clearly necessary. No adequate data from the use of fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Breast-feeding: Not recommended. No data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers’ fexofenadine was found to cross into human breast milk. Fertility: No human data available. Ability to Drive and Use Machinery: Based on the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective tests, Fexo Allergy Relief has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks. Undesirable Effects: Nervous system disorders: Common: headache, drowsiness, dizziness. Gastrointestinal disorders: Common: nausea. General disorders and administration site conditions: Uncommon: fatigue. Refer to the SPC for other undesirable effects. Marketing Authorisation Holder: Rowa Pharmaceuticals Limited., Newtown, Bantry, Co. Cork. Marketing Authorisation Number: PA0074/096/001 Further information and SPC are available from: Rowex Ltd., Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417 E-mail: rowex@rowa-pharma.ie

Legal Category: Not Subject to medical prescription. Date of Preparation: September 2024 CCF FOR API: 26741

Legal Category: Not Subject to medical prescription. Date of Preparation: September 2024

Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie) or by emailing Rowex pv@rowa-pharma.ie

Adverse events should be reported. Reporting forms and information can be emailing Rowex pv@rowa-pharma.ie

Date of preparation: (02/2025) CCF: 26995

Supply status: Supply through pharmacies only

of preparation: (02/2025) CCF: 26995

Date of preparation: (02/2025) CCF: 26995

Optimal Nutrition for Children

Katie Mugan is the founder of Nursing Mama, a registered General, Paediatric, and Public Health Nurse, as well as an International Board Certified Lactation Consultant. Through her busy private practice, she educates and supports both parents and healthcare professionals on breastfeeding.

Written by Katie Mugan, Nursing Mama

“Parents frequently seek advice on over-the-counter (OTC) medications, making it essential for pharmacists to be familiar with commonly used products”

Katie has just launched her first wearable breast pump to Amazon. com last month and the reviews are fantastic. In this article, Katie shares her insights on supporting breastfeeding parents within the community setting.

It is well-known within the medical profession that Ireland has one of the lowest breastfeeding rates globally, with only 64% of mothers initiating breastfeeding after birth. This is significantly lower than rates in Australia (90%), the UK (81%), and the USA (79%). However, encouragingly, data shows an 18.6% increase in the number of infants breastfed at three months since 2015, signalling positive progress.

There is no debate that breast milk is the optimal form of nutrition for an infant. However, it is every parent’s choice how they choose to feed their baby, and they should be supported in their decision. When breastfeeding is initiated, every mother produces milk specifically tailored to her baby’s needs. Breast milk

continuously adapts to support healthy brain development, growth, and immune function. Beyond nutrition, breastfeeding offers remarkable health benefits for both mother and baby. It reduces the risk of common infant illnesses such as otitis media, respiratory tract infections, gastrointestinal infections, and sudden infant death syndrome (SIDS), while also offering long-term protective effects against childhood obesity and diabetes. For mothers, breastfeeding is associated with a lower risk of ovarian and breast cancer, diabetes, and cardiovascular disease.

Despite these well-documented benefits, Ireland’s breastfeeding rates remain low. While multiple factors contribute to this, a primary reason is the lack of support and conflicting advice from healthcare professionals.

Community pharmacists are often the first point of contact for new parents seeking advice. A welcoming, knowledgeable, and supportive interaction with

a pharmacist can significantly impact a parent’s breastfeeding journey. As the most accessible healthcare professionals, pharmacists frequently engage with breastfeeding mothers and can play a pivotal role in providing guidance and reassurance, particularly concerning medication use while breastfeeding.

Concerns about medication safety often lead to unnecessary interruptions in breastfeeding. These brief interruptions can significantly impact milk supply and the overall breastfeeding experience. Pharmacists should only recommend cessation of breastfeeding if absolutely necessary and should utilize reliable resources to guide their recommendations. The American Academy of Paediatrics endorses LactMed as the most accurate and up-to-date database for medication use during lactation. Other valuable resources include ‘Medications & Mothers’ Milk’ and ‘The Breastfeeding Network’ (breastfeedingnetwork.org.uk), which provide evidence-based information on medications, illnesses, and procedures affecting breastfeeding mothers. Equipping parents with these resources empowers them to make informed decisions alongside their healthcare providers.

Parents frequently seek advice on over-the-counter (OTC) medications, making it essential for pharmacists to be familiar with commonly used products.

• Pain relief: Paracetamol & Ibuprofen is considered safe, but combination products containing codeine should be avoided.

• Hay fever & allergies: Non-sedating antihistamines are preferable and considered safe for short-term use.

• Cold & flu remedies: Many contain pseudoephedrine, which can reduce milk supply and should be avoided during lactation.

In addition to medication advice, pharmacists can provide invaluable support through practical breastfeeding solutions. Simple products and guidance can prevent a mother from prematurely stopping breastfeeding. Nipple discomfort is common in the early days, but persistent or severe

pain signals an issue that, if not addressed promptly, can lead to nipple trauma and early cessation.

While no nipple preparation is required before birth, ensuring a deep latch from the outset is crucial. Pharmacists can recommend helpful products such as:

• Nipple balms & compresses: MultiMam compresses, when chilled, provide soothing relief for sore nipples.

• Silver nipple cups: These have natural antimicrobial, antifungal, antibacterial, and anti-inflammatory properties. However, prolonged use can create an overly moist environment, leading to wound breakdown, so they should be used with caution.

• Nipple shields: Though sometimes controversial, these can offer temporary relief while the underlying cause of pain is being addressed.

• Nipple everters: These are particularly beneficial for mothers with flat or inverted nipples and can be a great addition to a hospital bag.

• Breast pumps: Some mothers may need to express milk out of necessity rather than choice. Hospital-grade breast pumps are highly recommended in such cases. Stocking these for rental allows parents to access them quickly, avoiding delivery wait times.

Creating a dedicated breastfeeding section within the pharmacy encourages parents to shop locally rather than online for their breastfeeding needs. This fosters a sense of community support and positions the pharmacy as a breastfeeding-friendly space.

As medication experts, pharmacists are in a unique position to support breastfeeding mothers. By offering accurate medication advice and stocking essential breastfeeding products, pharmacists can positively influence breastfeeding rates and outcomes. A proactive and supportive approach can help mothers navigate challenges, ultimately contributing to improved national breastfeeding rates and better health for both mothers and babies.

Strong Strong enough Stay for

with Two ... Two ...

Keeping Levels Healthy

Your pregnancy can be an exhilarating but sometimes tiring experience. Keep energy levels up by boosting your iron intake, so you can enjoy the time.

Floradix and Floravital contain iron gluconate, which is a highly absorbable form of iron.

Chapped lips, brittle hair, constant fatigue and palpitations are not on a prospective mum’s wish list. They are, however, some of the tell-tale signs of iron deficiency, which is common amongst pregnant women. Iron is needed to make haemoglobin, the chemical that transports oxygen in the blood. A range of stressful symptoms can indicate a deficiency, but severe cases can lead to anemia, total exhaustion and a weakened immune system. Throughout pregnancy, eating for two also means that your body requires twice the amount of iron to stay healthy.

A healthy, balanced diet with ironrich foods will provide most of the iron you need during pregnancy. This should include lean meats; pulses such as peas, beans and lentils; fruit such as prunes, apricots and raisins; and dark green leafy vegetables such as spinach. However, it can be difficult to absorb enough iron from a balanced diet alone for you and your growing baby, particularly if you have a deficiency as you need to eat a lot of iron-rich foods to correct it. This is where Floradix can really help. This high quality liquid supplement contains organic iron gluconate, and its easy absorption into the body is enhanced by vitamins C and B complex, herbal extracts and fruit juice concentrates. This special blend of ingredients mean that it’s easy to digest and the unpleasant side effects of many iron preparations, such as stomach cramps and constipation, are avoided. So it’s no wonder Floradix is recommended by numerous midwives and health care professionals.

What’s more, it’s completely free of chemical preservatives, colourings or flavourings, and is also available in a gluten-free form called Floravital.

Helping Absorption

Vitamin C, animo acids, fructose and glucose all help your body absorb more iron from foods and supplements. Other elements of our diet will decrease absorption, such as calcium, milk proteins, black tea, coffee, fibre, vitamin E and phosphates (found in soft drinks). So to maximise the amount of iron you are getting, take an iron supplement before eating.

Warning signs of iron deficiency

•pale skin under eyes and nails

•brittle hair

•cracked skin around mouth

•breathlessness when exercising

•heart palpitations

•rapid pulse

•difficulty concentrating

•cold hands and feet

•increased frequency of infection

Anewmum: Empowering New mothers postpartum

Marian Kennedy is empowering new mothers with her company PPR Healthcare Ltd. OTC range Anewmum

Marian Kennedy, the founder of Anewmum, is making significant waves in the female healthcare industry with her companies innovative approach to postpartum care and is transforming the recovery journey for new mothers. With a deep passion for female healthcare and a commitment to providing science-backed solutions, Marian and her team are dedicated to supporting new mothers and ensuring their well-being after they have given birth.

Anewmum: A Personal Journey to Innovation

Marian Kennedy's journey into the world of postpartum care began in 2015 following the birth of her first child. She faced numerous challenges in finding safe and effective products to aid her postpartum recovery. This personal experience ignited her determination to take matters into her own hands. Marian began developing a range of hygiene and skincare products specifically designed for new mothers, addressing the physical effects of pregnancy and childbirth.

This endeavour led to the creation of Anewmum, a brand that has since become synonymous with postpartum care and support throughout Ireland.

Anewmum's product line includes a variety of innovative solutions aimed at promoting healing, cooling, and soothing for postpartum women. Anewmums dedication to scientific research and collaboration with medical professionals has ensured that their products are both safe and

Marian Kennedy, founder of Anewmum

effective. The company's mission is to provide new mothers with the best possible care, by providing effective products and educating new mothers to navigate the oftenchallenging postpartum period.

A Commitment to Science and Support

Anewmums commitment to scientific research and evidencebased solutions has been a driving force behind the company's success. By partnering with

leading medical professionals and institutions, PPR Healthcare has ensured that Anewmum's products are grounded in rigorous research and tested for efficacy and safety.

One of the key partnerships that has propelled Anewmum forward is its collaboration with the The Centre for Applied Bioscience Research (CABR). This partnership has been instrumental in the development and accreditation of Anewmum's innovative solutions. Through this collaboration, Marian and her team have been able to leverage their research to create products that truly make a difference in the lives of new mothers. Their Anewmum Comfort Mist spray was tested for its wound healing properties on human dermal and epithelial cells by The Centre for Applied Bioscience Research. The results showed a greater reduction in scratch wound area in treated dermal skin cells after 24 hours and in vaginal epithelial mucosa

cells at 2, 4, and 6 hours compared to non-treated cells. This mist can be used for perineal massage pre-birth, post birth to support the discomfort from stitches and also post closed caesarean section to use with scar therapy massage. This year they will undertake their third study with CABR, which will focus on Mastitis.

Recognition and Future Endeavors

Marian and her teams hard work and dedication have not gone unnoticed. The most recent accolade to the company was an award of a ¤10,000 grant from the Visa She’s Next grant programme, which recognizes her outstanding contributions to female healthcare and the potential of her business. This funding will accelerate product development, support ongoing scientific research, and help bring innovative solutions to market faster. Marian's vision for the future of Anewmum is to

continue expanding its product range and reach, ensuring that more new mothers can benefit from the company's products. With a pipeline of products to launch in 2025, it will be an exciting year ahead.

In addition to the Visa She’s Next grant, Marian has received numerous accolades for her work in the female healthcare industry. Her commitment to improving postpartum care has earned her recognition from both medical professionals and new mothers alike.

Marian's vision for Anewmum is to provide comfort and care for new mothers, ensuring that their postpartum recovery is a positive experience. She believes that every new mother deserves access to safe and effective products that support their healing and wellbeing and by providing education to help women understand the importance of hygiene after giving birth can lead to a better postpartum period. This belief drives her ongoing commitment to innovation and excellence in pregnancy and postpartum care.

A Bright Future Ahead

As Anewmum continues to grow, it is dedicated to their mission of supporting new mothers. The company's success and continuous five start reviews are a reflection of their commitment to providing the best possible care for postpartum women. With a strong foundation in scientific research, innovative product development, and a deep understanding of the needs of new mothers, Anewmum is poised for continued growth and success.

Anewmum Product Range

The current Anewmum range consists of the three products, the Anewmum Comfort Mist RRP ¤28, Anewmum Postpartum Peri-wash bottle. ¤20 and their Anewmum Honeycomb Natural sea sponge to help with postpartum gentle washing RRP ¤20. New product launches to add to the range commence this summer.

Contact Information

If you wish to stock the Anewmum range in your pharmacy please email info@anewmum.com for an information pack.

You can contact Marian directly at mail: marian@anewmum.com, telephone: +353863513408

Anewmum is active across all social media channels at the @anewmum handle. You will find us on Instagram, Facebook, Tik Tok, Threads and Linkedin.

Here’s what our Customers are saying:

“The Comfort Mist Really helped me in my recovery, I have been recommending Anewmum to all my friends and would definitely use again!”

“The best thing I got after having my baby, would highly recommend to anyone pregnant”.

“I didn’t have these products for my first two babies so having them for my third baby was a game changer. I was so much better, so much faster. I just cannot recommend these products enough”.

“I got the peri-bottle as a present and to say it’s been a game changer is an understatement. The nurses keep asking me how am I keeping my stiches so clean.”

Understanding Gut Health in Babies and Children: A Pharmacist’s Perspective

Gut health in infants and young children is a critical aspect of their overall well-being. The gastrointestinal (GI) system plays a vital role in nutrient absorption, immune function, and maintaining body homeostasis. Among the common concerns parents face regarding their children’s gut health is diarrhoea, which can result from various causes, including infections, dietary factors, and even emotional distress. A day doesn’t go by where pharmacists do not encounter a worried parent with an unwell baby or child with symptoms of acute diarrhoea or upset gut. Pharmacists are in a unique position to offer valuable insights into managing these conditions, providing counseling on over-the-counter (OTC) therapies, probiotics, and addressing colic as well as reassurance and direction if the child needs to be referred.

Causes of Diarrhoea in Infants and Children

Diarrhoea is characterised by increased stool frequency and fluid content, and it can lead to dehydration and electrolyte imbalances, particularly in young children. Understanding the causes of diarrhoea is crucial for effective management.

Infections

Infections are among the most common causes of diarrhoea in children. Viruses like Norovirus and rotavirus are notorious for causing gastroenteritis, leading to fluid loss and discomfort. Norovirus is highly contagious and often spreads through contaminated food or surfaces, making it particularly relevant in settings such as creches or day-care. Bacterial infections—while less common— can also result from consuming contaminated food or water, with pathogens like E. coli and Salmonella being notable culprits.

Written by Tomas Conefrey, Conefrey's CarePlus Pharmacy

Non-Infectious Causes

Apart from infections, diarrhoea can also be prompted by noninfectious factors. For instance, food allergies or intolerances can adversely affect gut health. Lactose intolerance, due to insufficient lactase enzyme production, is particularly common and can lead to abdominal pain and diarrhoea upon consuming dairy products.

The Role of Probiotics

Probiotics have gained attention in recent years for their potential to support gut health, especially in children. These live microorganisms can positively influence the gut microbiota, which is essential for digestion and immune function.

Research indicates that certain strains of probiotics may help reduce the duration and severity of diarrhoea caused by infections, including rotavirus. In cases of antibiotic-associated diarrhoea,

probiotics can help restore the balance of gut flora compromised by antibiotic therapy. Pharmacists should consider advising parents on the use of age-appropriate probiotic supplements during episodes of diarrhoea or following antibiotic treatment to promote a healthier gut environment.

Choosing the Right Probiotics

When recommending probiotics, it is essential to select products that have been clinically validated with specific strains shown to provide therapeutic benefits. A product available in Ireland is Colief® Multibiotic Drops. Research suggests that good bacteria, such as those found in Colief Multibiotic Drops, can promote a healthy gut microbiome, which contributes to health during childhood and into adulthood.

Recent research for baby probiotics suggests that certain strains of beneficial bacteria particularly Bifidobacterium, have been shown to help support digestive health and reduce symptoms often associated with colic.

Oral Rehydration Solutions (ORS)

The cornerstone of diarrhoea management is rehydration. ORS are specially formulated to replace lost fluids and electrolytes. Simple solutions can be made at home with water, salt, and sugar, but commercially available ORS provide an effective means for rehydration. It may be helpful to provide an oral syringe for ease of administration or alternatively give the solution on a teaspoon or medicine spoon or in a feeding bottle with a low flow teat. Pharmacists should educate

Colic relief from Colief®

Adding Colief® Infant Drops to baby milk is a natural way to ease colic symptoms caused by lactose.

Infant colic can have many causes. In some cases it is caused by temporary lactose intolerance. This occurs when babies are unable to fully digest the lactose in milk, resulting in discomfort and extended periods of crying. Suitable from birth, Colief Infant Drops contain lactase enzyme, which breaks down lactose into glucose and galactose, reducing the lactose in milk and making it easier for babies to digest

INFANT DROPS

Colief® Multibiotic Drops, For a happy gut

Mums know to call on Colief® facebook.com/ColiefCare www.colief.com

Tel: 01 2968080 | orders@oceanhealthcare.ie | www.oceanhealthcare.ie

Your baby’s gut health is incredibly important as it sets the stage for their growth, immunity, and digestion. A healthy gut helps them absorb nutrients, stay protected from infections, and can help ease digestive discomfort such as constipation, diarrhoea and colic, contributing to your baby’s comfort and well-being.

Suitable for breastfed and formula fed babies, from birth onwards Colief® Multibiotic Drops can be taken once daily and contain 1.1 billion live CFU of Lactobacillus rhamnosus, LGG® and Biﬁdobacterium infantis, scientiﬁcally proven friendly bacteria for delicate stomachs.

20 Children’s Digestion

parents on recognising the signs of dehydration and the importance of maintaining hydration during a diarrhoeal episode.

Over-the-Counter Therapies for Diarrhoea

Pharmacists are often the first point of contact for parents seeking advice on managing diarrhoea. OTC therapies can be effective tools in addressing symptoms and preventing dehydration. If the child is less than 6 months old and symptoms have been present for more than 24 hours in duration they should

be referred immediately and oral rehydration salts should be provided as soon as possible. Likewise if the child is older than six months and has had symptoms for longer than 48 hours in duration I would treat that as a red-flag symptom and refer immediately.

Anti-Diarrheal Medications

While anti-diarrhoeal medications like loperamide are available for adults they are not available in liquid formulation in Ireland, instead as tablet and capsule presentations. Most pediatric patients, especially those

under the age of two, should not use these medications without consulting a healthcare professional. The primary objective in managing diarrhoea should be rehydration and protecting the child from dehydration.

Products available in Ireland include Tasectan® AF. Clinical trials have demonstrated that Tasectan AF® is a fast-acting, efficacious, and safe therapy for the treatment of acute diarrhoea, reducing the frequency and duration of diarrhoea episodes. Children under 3 years should be given a sachet every 8 hours and those over 3 years can be given 1-2 sachets every 6-8 hours.

Addressing Colic

Colic, characterised by excessive crying and apparent discomfort in infants, can also impact gut health. Although the exact cause remains unclear, it may be related to GI immaturity or food sensitivities. Pharmacists can offer guidance about soothing strategies or dietary adjustments that may alleviate symptoms. For example, some parents have found success using specific probiotic strains that may decrease colic symptoms. In 40% of colicky babies, colic may be linked to Temporary Lactose Intolerance, where the digestive system lacks enough lactase to break down lactose in milk. Colief Infant Drops help by providing lactase to break down lactose into simpler sugars, making milk easier to digest and reducing discomfort.

The Role of Counseling

Pharmacists play an essential role beyond product recommendations. Providing thorough counseling can ensure that parents understand the underlying issues related to their child’s gut health. The following points will guide and reassure anxious parents:

1. Provide lots of fluids such as water or squash - take small sips if you feel sick.

2. Give paracetamol if the child is in discomfort.

3. Carry on breast or bottle feeding your baby - if they are being sick, try giving small feeds more often than usual. Prepare formula at its usual strength, no need to make it weaker.

4. Give babies on formula or solid foods small sips of water between feeds.

Conclusion

The management of gut health in babies and children, particularly in relation to diarrhoea, is a multifaceted challenge for caregivers. As pharmacists, leveraging our expertise to provide education, recommend appropriate OTC therapies, and highlight the benefits of probiotics can significantly contribute to improving pediatric health outcomes. Ultimately, fostering a collaborative relationship with parents empowers them to make informed decisions for their children’s health. By prioritising gut health from a young age, we can promote a lifetime of well-being.

Stop Diarrhoea Fast Gentle Relief for a

Child’s

Tummy Troubles

Clinical trials have demonstrated that Tasectan AF® is a fastacting, efﬁcacious, and safe therapy for the treatment of acute diarrhoea, reducing the frequency and duration of diarrhoea episodes.

• Formula contains Xyloglucan and Gelose , which have muco-protective properties mimicking the natural mucosa in the intestine

• Fast symptom relief (within 6 hours)

• Controls and reduces associated symptoms: nausea, vomiting and abdominal pain Complementary treatment to rehydration products.

the accompanying leaflet carefully before use.

A DVA N CE D F O RM UL A

A DVA N CE D F O RM UL A Advanced Formula

Tasectan AF is a medical product. Please read

Preconception Nutrition

Pregnancy and Contraception Care in Pharmacy

Pre-Pregnancy & Fertility

Just over a third of couples will conceive in the first month of trying, while for others it can be a much longer road, with factors such as age, general health and reproductive health affecting how long it takes.

Around 1 in 6 couples in Ireland may experience issues with fertility. The growing demands of a modern lifestyle are having a significant impact on our nutritional health. Stress, anxiety, lack of sleep, dieting and poor nutrition all impact the bodies ability to absorb the nutrition needed to optimise reproductive health.

Improving nutrition and lifestyle for as little as three months before trying to conceive can make a noticeable difference to both genders as both the male and female reproductive systems need adequate nutritional support to contribute to sperm and egg quality.

Factors Affecting Fertility

Age: For women, the most fertile period is in their mid-twenties and fertility starts to decrease after the age of 35.For men, sperm is strongest in their mid-twenties and starts to decrease after the age of 40.

Smoking: Smoking can affect fertility in both men and women, it can affect the chances of conceiving for women and sperm quality in men.

Weight: A body mass index (BMI) of 30 or over is known to reduce fertility in men and women. While, for women, being underweight (BMI less than 18) can also affect ovulation.

Alcohol: For women planning to get pregnant, the HSE recommend the safest approach is not to drink alcohol at all. While for men drinking too much alcohol can affect the quality of sperm.

Stress: Stress can affect your relationship and cause a loss of sex drive. In severe cases, stress may also affect ovulation and sperm production.

Diet & Lifestyle: The HSE recommends all women begin taking folic acid at least 3 months before conception. There are number of other vitamins, minerals and amino acids that are known to be beneficial to the reproductive system, however it can be difficult to get all of these nutrients in the diet in today’s busy world. This is where supplements can help, by providing extra support needed to support good pre-conception health.

How Do Fertility Supplements Work?

Supplements can help to correct nutritional deficiencies associated with the reproductive cycle by supplying the raw materials needed to support the reproductive system so it can function optimally.

For Women: Supplements can support the nutritional needs of the female reproductive system. Getting the environment right and developing good quality egg cells are key factors when trying for a baby.

Nutrients play an important role in the development of the egg, womb and the hormonal system. Each month, the reproductive and hormonal cycle develop an egg cell, prepare the womb and a myriad of other processes have to be performed to create the right fertile balance.

Egg quality can be enhanced if it is released into a healthy nutritious environment. Fostering a good diet and ensuring that you are taking the essential nutrients can positively effect the health of your eggs and subsequently the developing foetus.

For Men: Men have to produce between 40 and 300 million sperm cells to be fertile. This is an intensive process and the energy involved in creating these cells is significant. Getting the environment right and developing good quality sperm cells are key factors when trying for a baby. A deficiency in any nutrient may have an impact on male fertility. Improvements to both sperm quality and quantity can be made in as little as 3 months.

Key Nutrients for Conception: Look for a combination of Folic Acid, Vitamins, Minerals, Amino Acids, CO-Q10 & Omega 3 DHA.

Folic acid contributes to normal maternal tissue growth during pregnancy. The HSE recommends all women begin taking 400ug folic acid at least 3 months before conception.

Minerals including Calcium, Magnesium, Iron, Zinc, Copper (gluconate), Manganese, Selenium, Chromium, Molybdenum, Iodine, Boron, are essential for both male and female reproductive health. Minerals work together creating a synergy. Multiple mineral deficiencies are common amongst many women particularly those who have been using hormonal contraception.

Vitamins are vital for the production of energy in the body. Sufficient energy production is required for reproductive health. Key reproductive vitamins are: Beta Carotene, Vitamin B1 (Thiamin), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B5 (pantothenic acid), Vitamin B6 (Pyridoxine), Folic acid, Inositol, Biotin, Vitamin C, Vitamin D, Vitamin E, Vitamin K1

Amino acids are the building blocks of proteins necessary for growth and repair in the body. Look for: L'Arginine, L'Carnitine, L'Citruline, L'Glutamine, N-AcetylL-cysteine, Glycine, Taurine

Antioxidants such as Co-Q10 are important for reproduction. Co-Q10 is a powerful antioxidant and energy power house. It is present in the membrane of almost every cell in the body.

Omega 3 DHA contributes to the maintenance of normal brain function and vision. During pregnancy, essential fatty acids are important to the baby’s brain and eye development

Pharmacy teams have the unique role as accessible healthcare providers to optimise preconception health, such as in screening tobacco and alcohol use, in offering advice on preconception risk factors and current medication use.

Heartburn and Indigestion

Many women suffer from both heartburn (acid reflux) and indigestion during pregnancy and it tends to become more common as the pregnancy progresses. In fact, by the third trimester nearly three quarters of pregnant women can suffer from heartburn.

Iron for Kids.

Preconception Nutrition

There are two main reasons why heartburn and, to a lesser extent, indigestion are common at this time:

1. The surge in the hormone progesterone causes muscles to relax. This includes the sphincter (ring of muscle) at the entrance to the stomach. When this relaxes, stomach acids are able to travel back up into the oesophagus (food pipe) causing heartburn.

2. During the latter stages of pregnancy symptoms can also be caused by the baby physically putting pressure on the woman's digestive tract. Although harmless to the baby, heartburn and indigestion can be painful and uncomfortable for expectant mothers and pharmacists can advise patients that eating a healthy diet and sitting and/or sleeping in a more upright position can help ease heartburn and indigestion.

Fatigue

Fatigue is an early sign of pregnancy which nearly all women experience in the first trimester that can begin weeks after conception and implantation. It typically gets better around the start of the second trimester and returns in

the third trimester, though it varies from pregnancy to pregnancy.

A number of tips to give expectant mums include:

1. Get enough rest. Advising a patient to start by going to bed earlier, and take naps during the day when they can. Even a 15-minute catnap can make a difference.

2. Stay hydrated. Cutting back on caffeine, and making sure plenty of water is consumed. If frequent urination is keeping a patient up at night, suggest drinking less water a few hours before bedtime and making up for it during the day.

3. Exercising regularly. Getting at least 20-30 minutes of moderate activity, such as walking can also help a patient feel less fatigued and that they have more energy

Morning Sickness

Despite its name, can happen any time of day or night. It’s also extremely common affecting over 80% of mums-to-be.

Although it’s not known exactly what causes expectant mums to feel nauseous, it’s most likely that the feelings of nausea are all down to hormones, particularly Beta

There are a number of suggestions pharmacists can make to alleviate symptoms:

1. Use a warm compress on the area where pain is being experienced.

2. Placing a pillow between the legs to better align the pelvis and take some pressure off the sciatic nerve.

3. Strengthen the core and reduce inflammation with pelvic tilts and kegel exercises.

4. Use a cold compress to provide cooling relief for back pain.

Medication taking whilst pregnant

hCG, although it is thought that it can be due to a lack of vitamin B6, too.

There are several techniques that although have not been scientifically proved to work, have been frequently noted as helping subside the nausea symptoms for pregnant women.

1. Eating little and often, 6 meals a day.

2. Avoiding food with lots of sugar or saturated fats – such as sweets, chocolate and red meat.

3. Avoiding “trigger” foods or smells that make a patient feel sick.

4. Trying food or drinks that contain ginger.

5. Wearing acupressure bands throughout the day.

Sciatica and Muscular Back Pain

As many as 98% women will suffer from muscular back pain at some stage during their pregnancy. The pain is caused by the additional weight and changes in the body during pregnancy; hormonal changes can cause ligaments which support the spine to become loose, which puts more pressure on the lower back.

As 50% of pregnancies are unplanned, a woman often discovers she is pregnant while already taking a medication and visits a pharmacy which is easily accessible, to enquire if she has harmed her baby by this action. Whilst studies show there may be a lack of adequate information regarding use of certain medications during pregnancy, it has been suggested that pharmacists should be able to integrate available information with their medication expertise, to make appropriate individual risk/ benefit decisions. This requires active engagement with pregnant women, rather than automatically referring them to their physician. The trimester of the pregnancy often plays an important part in whether medications can be taken, for example Some medicines can be dangerous to take in the first three months but safe in the second or third, or vice versa.

Current recommendations are that women should take 400mcg folic acid daily from before pregnancy until the end of the first trimester, and 10mcg vitamin D daily throughout pregnancy and while breastfeeding.

The role of folic acid in reducing the risk of neural tube defects and the value of vitamin D supplements in building bone formation in babies is well supported. Expectant mothers can therefore be reassured that it is not necessary to invest in expensive multivitamin supplements, and that eating a good balanced diet during pregnancy, along with folic acid and vitamin D supplements, should be all that is required to ensure the best possible health outcomes for both themselves and their unborn child.

Valeo Healthcare, Merrywell Industrial Estate, Ballymount, Dublin 12. For general queries: 01 405 1500. Email: valeohealthcare@valeofoods.ie. 1. Journal of the American College of Nutrition, Vol.18, No.5, 487-489 (1999). 2. For more information on this research, please visit www.pregnacare.com/mostrecommended. 3. Based on a survey of 1000 midwives. 4. Folic acid contributes to maternal tissue growth during pregnancy. Pregnacare® has always contained 400mcg folic acid, the level recommended for all women from the start of trying to conceive until the 12th week of pregnancy. 5. The Department of Health recommends that all adults, including pregnant and breastfeeding women, should consider taking a daily supplement containing 10μg of vitamin D between September and March. (Source: www.NHS.uk). 6. Agrawal, R. et al. Prospective randomised trial of multiple micronutrients in women undergoing ovulation induction, Reproductive BioMedicine Online December 2011. 7. L Brough et al. Effect of multiple-micronutrient supplementation on maternal nutrient status, infant birth weight and gestational age at birth in a low-income, multi-ethnic population. British Journal of Nutrition (2010), 104, 437-445.

DURING PREGNANCY BEFORE

AFTER

Pregnacare® Conception with 21 nutrients including folic acid as recommended for all women trying to conceive.

More than just folic acid Most

trusted by mums2

Pregnacare® Original with19 nutrients including folic acid and vitamin D as recommended by the Department of Health.

Helping to keep mums and babies healthy for over 30 years, Pregnacare® provides the recommended level of folic acid4 and vitamin D which is advised by the Department of Health.5 It also provides a range of micronutrients, and is supported by unique clinical research with mums-to-be.6,7

Most recommended by midwives 2,3

Breast-feeding with

nutrients including 10µg vitamin D and 300mg DHA for mums during lactation.1

and 300mg DHA for mums during lactation.

For more information on promotions and POS, contact your Valeo Healthcare Account Manager or Territory Manager Lisa Kelly 086 206

DURING AFTER

For more information on promotions and POS, contact your Valeo Healthcare Account Manager or Territory Manager

Lisa Kelly 086 206 1449 Lisa.Kelly@valeofoods.ie

Mike Peters 086 856 2077 Mike.Peters@valeofoods.ie

Chris Ferncombe 086 033 8162 Chris.Ferncombe@valeofoods.ie

Stephen Moloney 087 699 9344

For more information on promotions and POS, contact your Valeo Healthcare Account Manager or Territory Manager

Gary Considine 087 933 4227 Gary.Considine@valeofoods.ie

Lisa Kelly 086 206 1449 Lisa.Kelly@valeofoods.ie

Mike Peters 086 856 2077 Mike.Peters@valeofoods.ie

Gary Considine 087 933 4227 Gary.Considine@valeofoods.ie

Stephen.Moloney@valeofoods.ie Marie Amond 086 168 2230 Marie.Amond@valeofoods.ie

Impact of RSVpreF vaccination on reducing the burden of respiratory syncytial virus in infants and older adults

Written by: Zhanwei Du, Abhishek Pandey, Seyed M. Moghadas, Yuan Bai, Lin Wang, Laura Matrajt, Burton H. Singer & Alison P. Galvani

Respiratory syncytial virus (RSV) remains a leading cause worldwide of acute lower respiratory tract illness (LRTI) among children under 5 years of age1,2, with the highest burden occurring within the first 6 months of life.3 Up to 2% of young children in high-income countries are hospitalised for the management of RSV-associated illnesses, including bronchiolitis, pneumonia, apnea and difficulty in feeding.4,5 RSV can also cause serious illness in older adults, especially among those with comorbidities and risk factors,6 often leading to severe outcomes and hospitalisation. A metaanalysis of high-income countries reported a case-fatality rate of 7% in older adults admitted with RSV-associated LRTI7. The burden of RSV has been comparable to that of seasonal influenza among older adults,8 resulting in substantial short- and long-term healthcare costs and productivity losses.9,10,11,12

Despite continuous efforts to develop RSV vaccines since the 1960s, no vaccine was sufficiently promising to enter phase 3 clinical trials until recently. Historically, RSV prevention among infants has

relied on palivizumab, an expensive, short-term monoclonal antibody administered in five monthly doses to high-risk infants each RSV season.13 Leveraging advances in structure-based vaccinology, the most immunogenic epitopes and conformations were identified to inform the design of vaccines and long-acting monoclonal antibodies.14 Notably, a proteinbased vaccine (Abrysvo) is now available to immunise pregnant women between 32 and 36 weeks of gestational age to protect infants through the first 90 days of life after birth.15 In addition, Prefusion F protein-based (RSVpreF) vaccines (Abrysvo and Arexvy) have become available for the prevention of RSV disease in older adults.16,17 Alongside these vaccines, a long-acting monoclonal antibody (nirsevimab) is approved for infant immunisation against RSV-related LRTI in several countries.18,19 Although nirsevimab provides direct, nonactive protection for infants, the lower costs of RSVpreF vaccination20 may provide a more affordable strategy for reducing disease burden in older adults, pregnant women and infants.

With the availability of RSVpreF vaccines, quantification of health benefits is essential to inform vaccination strategies.12,21 In this study, we developed an individualbased simulation model of RSV transmission dynamics with vaccination to estimate the number of RSV-related hospitalisations and deaths averted among infants and adults aged 60 years or older in 13 high-income countries from different regions across the world, including the United States, Canada, United Kingdom, Germany, France, Italy, the Netherlands, Sweden, Spain, Ireland, Israel, Japan and Australia. We considered vaccine efficacy against severe outcomes (that is, preventing hospitalisation), but assumed no vaccine-induced protection against infection or transmission. Incorporating country-specific demographics, age-dependent contact patterns and estimates of disease burden, we simulated the model with influenza-like vaccination uptake rates to provide a multinational perspective on the impact of RSVpreF vaccination programs in these countries. Using model estimates for each country, we further calculated the direct costs of RSV-related hospitalisations and the years of life lost (YLL) averted by vaccination.

Results

We estimated the effective reproduction number, Re (that is, the average number of secondary infections generated by an RSV case), using weekly positivity rates reported for the 2018–2019 RSV seasons across the countries studied here. Australia showed the lowest mean Re value at 1.29, while Germany exhibited the highest at 1.99. Calibrating the transmission dynamic model to country-specific Re values (Extended Data Fig. 1), we ran stochastic simulations to project the total number of hospitalisations and deaths in the absence of vaccination as the baseline scenario.

Without vaccination, the annual burden of RSV varied substantially across the 13 countries studied, with hospitalisations ranging from a median of 27.9 (95% uncertainty range (UR): 27.0–28.7) per 100,000 older adults in Israel to 214.0 (95% UR: 204.7–222.1) in the United States. Similarly, RSV-related mortality per 100,000 population of older adults varied from a median of 1.8 (95% UR: 1.7–1.8) in Israel to 20.8 (95% UR: 19.9–21.7) in Canada.

Among the infant population, Ireland had the lowest estimated

Fig 1: a,b, Estimated reduction in older adults (a) and infants (b). Error bars represent median values and 95% UR of 500 stochastic simulations with vaccination of older adults (a) and pregnant women (b)

Fig 2: Assuming uptake rates similar to seasonal influenza vaccination in each country, the vaccination scenario is compared with the baseline scenario (without vaccination), with countryspecific reproduction numbers estimated for the 2018–2019 RSV season. Colored bars represent median values of estimates for vaccination of older adults (red, per 100,000 older adults) and pregnant women (cyan, per 100,000 infants), with error bars indicating 95% UR from 500 stochastic simulations

hospitalisation rate, with a median of 520.7 (95% UR: 0–813.5) per 100,000 infants, while the Netherlands exhibited the highest at 3,373.0 (95% UR: 3,104.4–3,611.8). RSV-related mortality also varied substantially, ranging from a median of 0.14 (95% UR: 0.12–0.16) per 100,000 infants in Australia to 3.6 (95% UR: 3.3–3.9) in Israel. Across the countries studied, estimated YLL exceeded 280.2 (95% UR: 268.8–290.6) per 100,000 older adults and 311.5 (95% UR: 271.8–377.9) per 100,000 infants.

Health outcomes with vaccination

We applied the calibrated model specific to each country and implemented vaccination programs targeting older adults and pregnant women, mirroring the reported vaccine coverage of these population groups for seasonal influenza preceding the COVID-19 pandemic. Among older adults, averted hospitalisations attributed to RSV vaccination ranged from a median of 15.0 (95% UR: 13.9–16.1) per 100,000 population in Israel to 135.0 (95% UR: 128.9– 142.4) in Canada. The corresponding vaccination uptake rates were reported at 59.8% in Israel and 70.0% in Canada. The estimated numbers of RSV-related deaths averted by RSV vaccination varied, with the lowest at 1.0 (95% UR: 0.9–1.0) and the highest at 11.2 (95% UR: 10.5–11.8) per 100,000 population of older adults, in Israel and Canada, respectively. The reduction in deaths attributed to RSV vaccination varied from 35.2% in Germany to 64.5% in the United Kingdom (Table 1). Based on averted deaths among older adults in each country, we

Hospitalisation costs averted (xUS$1,000)

estimated YLL prevented by RSV vaccination, which ranged from 21.5 (95% UR: 19.7–23.2) per 100,000 population in Israel to 168.7 (95% UR: 158.6–177.9) in the United States.

Among pregnant women, the highest vaccination uptake rates were observed in Australia (61%) and Ireland (61.7%). Compared with the no-vaccine scenario, vaccination of pregnant women would avert a median of 1,060.9 (95% UR: 599.0–1,335.3) RSVrelated hospitalisations per 100,000 infants in Australia, representing the most substantial reduction per capita among all countries studied here. With a 47.4% vaccination coverage of pregnant women, Japan had the largest number of RSV-related mortalities averted, with a median of 1.3 (95% UR: 0.6–1.8) per 100,000 infants. The reduction in deaths attributed to RSV vaccination varied from 4.8% in France to 49.7% in Ireland.

Simulating vaccination scenarios, we calculated the relative reduction in hospitalisations for each country (Fig. 1). The reduction in hospitalisation achieved by vaccination of older

adults ranged from 35.2% (95% UR: 33.5–37.1%) in Germany to 64.5% (95% UR: 62.4–66.5%) in the United Kingdom (Fig. 1a). In the case of vaccination of pregnant women, France showed the lowest reduction in RSV-related hospitalisations among infants, with a reduction of 4.8% (95% UR: 1.0–7.4%), while Ireland exhibited the highest reduction, of 49.7% (95% UR: 28.9–70.5%) (Fig. 1b), reflecting vaccination coverage of pregnant women.

Hospitalisation costs averted by vaccination

Using country-specific costs of RSV-related hospitalisation, we calculated the direct costs averted by RSV vaccination. Costs averted by vaccination of older adults ranged from US$45,202 (95% UR: US$42,100–48,803) in Israel to US$2,540,408 (95% UR: US$2,375,525–2,679,474) in the United States per 100,000 population of adults aged 60 years or older (Fig. 2, red bars). Hospitalisation costs averted per 100,000 infants attributed to the vaccination of pregnant women were lowest in France, at US$498,163 (95% UR: US$117,922–940,689) and highest

in Australia, at US$17,855,740 (95% UR: US$9,868,897–22,865,179) (Fig. 2, cyan bars).

Secondary analyses

To investigate the effect of vaccination coverage on the reduction of RSV burden and associated hospitalisation costs, we conducted additional scenario analyses by varying uptake rates in each country. Setting the vaccination coverage to 73% for older adults and 62% for pregnant women in all countries, the reduction in hospitalisations (compared with baseline) was similar across the countries studied, with overlapping uncertainty ranges of 62–73% for older adults and 18–72% for infants. For the lowest coverages of 38% for older adults and 7% for pregnant women, the reduction in hospitalisations was substantially lower but still consistent across countries, with overlapping uncertainty ranges of 28–41% for older adults and 0–19% for infants.

We further considered countryspecific vaccination coverage of seasonal influenza reported during and after the COVID-19 pandemic. Simulating the model with the

PROTECT AGAINST RSV 3

Over 3 RSV seasons, a single dose of AREXVY demonstrated sustained efficacy against RSVLRTD in adults aged 60 years and older 1,2

SEASON 1 OVERALL EFFICACY IN PROTECTING AGAINST RSV-LRTD3** 82.6% 82.6%

SEASON 1 EFFICACY IN PROTECTING AGAINST RSV-LRTD FOR PARTICIPANTS WITH AT LEAST 1 COMORBIDITY OF INTEREST†3** 94.6%

AREXVY has a clinically acceptable safety profile1

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)

AREXVY (1 case out of 4937), placebo (18 cases out of 4861)

**Season 1 data with 6.7 months follow up.

Vaccination may not protect all recipients. 2

*RSV=respiratory syncytial virus; RSV-LRTD=respiratory syncytial virus-associated lower respiratory tract disease CI=Confidence Interval

†Comorbidities of interest^1: chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease (endocrinometabolic).

Arexvypowder and suspension for suspension for injection. [Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)].

(Please refer to SmPC before prescribing).

Composition: After reconstitution, one dose (0.5 mL) contains: RSVPreF31 antigen2,3 120 micrograms. (1RSV recombinant glycoprotein F stabilised in the pre-fusion conformation = RSVPreF3, 2RSVPreF3 produced in Chinese Hamster Ovary cells by recombinant DNA technology), 3adjuvanted with AS01E containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 25 micrograms, 3-O-desacyl-4’-monophosphoryl lipid

A (MPL) from Salmonella minnesota 25 micrograms. Therapeutic indications: Active immunization for the prevention of lower respiratory tract disease caused by RSV in adults 60 years and older and in adults 50 through 59 years of age who are at increased risk for RSV disease. The use of this vaccine should be in accordance with official recommendations. Posology and method of administration: For intramuscular injection only, preferably in the deltoid muscle. Administered as a single dose of 0.5 ml. Revaccination: need not established. Contraindications: Hypersensitivity to the active substances or any of the excipients. Special warnings and precautions for use: The name and the batch number of the administered product should be clearly recorded. Appropriate medical treatment and supervision should be readily available in case of an anaphylactic event. Vaccination should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in deferral. A protective immune response may not be elicited in all vaccinees. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur. Precautions should be in place to avoid injury from fainting. Never administer intravascularly or intradermally; no data available on subcutaneous administration. Caution in individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration. Safety and immunogenicity data on Arexvy are not available for 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

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. Undesirable effects: Very common (≥1/10): Headache, myalgia, arthralgia, injection site pain, injection site erythema, fatigue. Common (≥1/100 to <1/10): injection site swelling, fever, chills. Uncommon (≥1/1000 to <1/100): lymphadenopathy, hypersensitivity reactions, nausea, abdominal pain, vomiting, injection site pruritus, pain, malaise. Legal Category: POM A. Marketing Authorisation Number: EU/1/23/1740/001-002. Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A., Rue de l’institut 89, B-1330 Rixensart, Belgium. Further information is available from GlaxoSmithKline (Ireland) Ltd. 12 Riverwalk, Citywest Business Campus, Dublin 24. Telephone: 01-4955000. Code: PI-11947. Date of preparation: September 2024.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Please see full Prescribing Information for AREXVY, on Medicines.ie.

References: 1. Arexvy SPC, www.medicines.ie (accessed September 2024). 2. Michael G. Ison,et al., on behalf of 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, 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.

vaccination of older adults, we found trends in the reduction of hospitalisations similar to those derived in the baseline scenario with country-specific vaccination coverage before the COVID-19 pandemic. The median reduction in hospitalisations ranged from 39% in Germany to 70% in the United Kingdom. In regard to vaccination of pregnant women, median reduction in hospitalisations among infants varied from 10% in Germany to 44% in Spain.

Discussion

The availability of RSVpreF vaccines provides an important public health measure to mitigate the burden of RSV disease among infants and older adults. Our analysis indicates that vaccination can substantially reduce RSVrelated hospitalisations and deaths, averting inpatient costs. However, this impact varies across countries and is influenced by both uptake rates and local epidemiological characteristics of RSV seasons. For example, Germany has one of the highest burdens of RSV among European countries, with an annual average of 127 hospitalisations per 100,000 adults aged 65 years or older,22 incurring substantial direct and indirect healthcare costs.23 Given the low influenza vaccination coverage of 38.8% among older adults in Germany, the estimated reduction in RSV-related hospitalisations remains under 40% in this population. Similarly, in countries such as France, Germany and Italy, where maternal immunisation uptake rates are low, the estimated reductions in infant hospitalisations remain under 20% (Fig. 1).

Our secondary analyses show that the outcomes of RSV vaccination may vary across populations, even under the assumption of similar uptake rates and transmissibility; for example, the United States, Canada, Ireland and Japan have similar reproduction numbers, between 1.4 and 1.5. When the vaccination coverage was set to 73% for older adults and 62% for pregnant women across these countries, the projected hospitalisations averted per 100,000 population of older adults varied from 72.5 (95% UR: 1.7–93.0) in Ireland to 140.8 (95% UR: 133.7–148.7) in Canada, indicating the impact of demographic characteristics on vaccination outcomes. However, the relative reductions in outcomes were similar, despite the varying burden of RSV among these countries.

Our model, calibrated to countryspecific reproduction numbers,

produces hospitalisation rates consistent with those published in the literature. For instance, one systematic analysis of global, regional and national disease burden reported an overall annual rate of 17.8 (95% UR: 11.9–26.6) hospitalisations per 1,000 infants in high-income countries (using studies with quality scores >0.6).2 In the absence of vaccination, hospitalisation rates estimated in our model per 1,000 infants range from 5.2 (95% UR: 0–8.1) in Ireland to 33.7 (95% UR: 31.0–36.1) in the Netherlands. Similarly, the model generates hospitalisation rates per 100,000 older adults ranging from 97.7 (95% UR: 94.5–100.6) in Sweden to 214.0 (95% UR: 204.7–222.1) in the United States, largely consistent with the unadjusted annual hospitalisation rate of 157 (95% CI: 98–252) in industrialised countries.7

In alignment with previous studies,24,25,26,27 our analysis demonstrates the potential for substantial health benefits from RSVpreF vaccines, assuming high vaccination uptake rates. However, uptake rates will depend on various factors such as vaccine acceptability, out-ofpocket costs for receiving RSV vaccines, the inclusion of eligible population groups in publicly funded programs and specific recommendations for program implementation in different countries, which are influenced by cost-effectiveness evaluations of these vaccines.12,21,28,29,30

Recommendations are likely to consider other RSV interventions, such as nirsevimab, which offers an alternative to maternal vaccination by providing passive immunity to infants. For instance, a recent cost-effectiveness analysis of RSV preventive measures in Canada found that a combined strategy of vaccinating pregnant women with RSVpreF vaccines and immunising high-risk infants with nirsevimab during the RSV season was cost effective, while being comparable to an all-infant, nirsevimab-only program in reducing infant hospitalisations and mortality.21 However, despite regulatory approvals for the use of nirsevimab in several countries studied here, program implementation for infant immunisation remains challenging due to limited supply and high costs, even in high-income countries.31,32,33,34,35,36

Recommendations may also vary across countries, influencing the uptake and prioritisation of RSVpreF vaccines and

nirsevimab. For example, in the United States, infants whose mothers have been immunised with RSVpreF vaccines may not receive nirsevimab (depending on risk factors and gestational age),37 making nirsevimab uptake uncertain and dependent on RSVpreF vaccine uptake in pregnant women. Given these uncertainties and varying recommendations, and considering additional factors including costs, our analysis did not include nirsevimab for infant immunisation.

Our study has several limitations. First, we implemented uptake rates at the beginning of model simulations, corresponding to the start of the RSV season in each country. However, vaccination probably occurs throughout the season, and effective uptake rates at the onset of the RSV season may differ from those used in our analysis. In addition, we also used reported vaccine efficacy estimates from clinical trials. However, the real-world effectiveness of these vaccines remains unknown and would be influenced by the characteristics of eligible population, comorbidities and other RSV-associated risk factors. Second, we focused only on the direct benefits of vaccination against severe disease outcomes (hospitalisation and death), and on the reduction of costs associated with RSV-related hospitalisations. Additional benefits of vaccination, such as reduced rates of medically attended symptomatic RSV for outpatient care, were not considered in this study.12,21,28,38,39 Furthermore, while current evidence is limited, vaccination may reduce transmission and circulation of the virus due to potential herd immunity effects. Without accounting for these factors, our results regarding the health benefits of vaccination are probably conservative. However, in the absence of data on the indirect effects of vaccination against infection or transmission, our model assumptions relied on existing evidence that RSV infection does not confer durable immunity and that reinfection is common.40 Third, we evaluated RSVpreF vaccination over a 1-year time horizon consisting of a single RSV season. However, these vaccines have shown protective efficacy against severe RSV LRTI over two seasons,41,42,43 which could affect uptake rates. Fourth, our estimates of reproduction numbers rely on reported RSV positivity rates in the countries studied. However, various

factors can influence such rates, including risks and care-seeking behaviour, testing practices and seasonal forcing. Fifth, our analysis uses hospitalisation costs from published estimates, which may be influenced by the population study as well as the utilisation of critical care resources by inpatients. Sixth, we did not account for the costs of vaccination programs in our analysis, and thus net direct healthcare cost savings would differ from those estimated here. Costs of vaccination programs would include vaccine transportation, storage, administration, promotion and outreach, wastage and the price per dose of vaccines, which varies by country due to manufacturers’ negotiations. Finally, the cost effectiveness of RSVpreF vaccines and the impact of nirsevimab alongside vaccination were not evaluated in our analysis. Such evaluations would require an extension of the model structure to include country-specific inputs, such as the outpatient burden of RSV and associated costs, recommendations for use of these interventions (for example, risk factors and gestational age of infants) and estimates of productivity losses due to RSVrelated illness.12,21,26,28,44

Given the recent introduction of RSV vaccines in 2023, there is limited real-world experience with vaccine program implementation. Although we used country-specific influenza vaccination coverage in our baseline analysis, recent estimates indicate a substantially lower uptake of RSVpreF vaccines during the 2023–2024 season.45,46,47,48 Addressing vaccine hesitancy, awareness and accessibility should improve uptake rates, thereby enhancing the impact of RSV vaccination campaigns.

Within a few years, the landscape for the prevention of RSVassociated illness has significantly changed, and practical strategies to protect infants and older adults have become available. Our analysis underscores the importance of these advancements, demonstrating that the use of RSVpreF vaccines could substantially reduce the burden of RSV disease. As new data and evidence on the real-world effectiveness of these vaccines accumulate, additional studies can inform optimal vaccination scenarios in different populations. References available on request

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 anti-arrhythmic 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.

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.

within 6 months or after 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. Co-administration 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.

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

Get gut-ready for spring with Optibac Probiotics

As the days grow longer and social calendars begin to fill up, Irish women are preparing to embrace the brighter days ahead. But for many, digestive concerns like bloating, IBS, and sensitive tummies can quickly get in the way of a good time. That’s why Optibac Probiotics, Ireland’s most trusted & recommended brand of friendly bacteria supplements†, are on a mission to help everyone feel good from within this spring.

Why spring can be tough on the gut

Bloating, indigestion and symptoms of IBS can all be triggered when attending more social events, eating out and indulging outside of our normal diet and mealtimes. Spring also marks the start of hay fever season, which can present further challenges for digestive health.

Nutritional Therapist Hannah Glithero sheds light on the science behind why gut health and seasonal allergies don’t mix:

“When excess mucus is produced in the nasal passages from hay fever, we commonly expect to see a runny nose. However, a lesser known side to this process shows we also naturally swallow mucus and allergens, which make their way into our digestive system. These intruders can irritate the oesophagus and stomach lining, which in turn can cause symptoms such as heartburn, indigestion and nausea, as well as worsening conditions such as gastroesophageal reflux disease (GERD).”

However, making one small change to consumers’ daily routines by including a scientifically proven probiotic supplement, could make all the difference to digestive health during seasonal transitions.

Empowering consumers to take control

In a recent survey commissioned by Optibac, it was revealed the top reason why Irish women want to take probiotics is so they can

feel more in control of their health (45%), while 35% want to feel like the best version of themselves. Yet, only 1 in 10 consumers feel very knowledgeable about probiotic supplements.

This is where Optibac Probiotics shines. With 20 years of research and a wide range of scientificallybacked supplements, Optibac helps consumers make informed choices that align with individual health needs.

“The gut microbiome is as unique as a fingerprint,” says Hannah Glithero. “Choosing a supplement with strains specifically researched to address specific health concerns can make all the difference to customer’s daily wellbeing. Our goal is to give people the power of gut health so they can feel their best every day when they opt for Optibac.”

Friendly bacteria supplements your customers can trust

With 14 different formulations, Optibac makes it easy to find the right friendly bacteria for every kind of customer. Plus, to support the nation’s gut health this season and beyond, Optibac is launching a national radio campaign to raise awareness on the power of friendly bacteria, also supported by a 20% off trade promotion across selected favourites this April.

Here are five popular options you can feel confident recommending to your customers – all backed by gold standard science and shown to support top digestive complaints:

Optibac Gut Health Gummies: Ideal for those wanting an all-rounder

Naturally delicious mixed berry gummies with friendly bacteria, plus Vitamin D & Zinc to maintain immunity, Calcium to support digestion and FOS fibres which increase natural gut bacteria; all in one daily supplement.

RRP: ¤15.95 for 30 gummies

Optibac Every Day: Ideal for those wanting great value, backed by science

Our No.1 choice for anyone looking for a bestselling, highly recommended friendly bacteria supplement. Make every day count with this daily multi-strain formulation, which includes 6 extensively researched strains to support gut health and overall wellbeing.

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Breastfeeding and Lactation Knowledge, Attitudes and Training among Community Pharmacists in Ireland

Written by Denise McGuinness1, Niamh Vickers2

1Assistant Professor in Midwifery, School of Nursing, Midwifery & Health Systems, University College Dublin

2Assistant Professor Public Health Nursing, School of Nursing, Midwifery & Health Systems, University College Dublin

Introduction

There is increasing evidence of the importance of breastfeeding and human milk for mothers, infants and society at large; with a dose response relationship according to breastfeeding duration and exclusivity (Lackey et al., 2021). Earlier benefits of breastfeeding for infants include a reduced risk of infection, obesity, sudden infant death syndrome and diabetes (Rollins et al., 2016, Victora et al., 2016). Infants and young children are best supported to survive, grow and reach their developmental milestones when they receive mothers milk (Perez Escamilla et al. 2023). In women, breastfeeding offers protection against breast and ovarian cancer, cardiovascular disease and supports post-partum weight loss (Chowdury et al, 2015). More recently, breastfeeding is discussed in relation to planetary health. It plays an important role in reducing carbon emissions and also sustainable living (Smith, 2019).

While Norway and Sweden report high breastfeeding rates above 90% (Vik et al 2023; Cato et al. 2020), unfortunately breastfeeding rates are low in Ireland. This is despite the World Health Organization (WHO) (WHO, 2019) recommendations that infants are breastfed exclusively for the first six months of life and up to two years or beyond, in combination with safe complimentary foods. In Ireland 64% of women initiate breastfeeding and exclusive

breastfeeding rates at 3 months post-partum are reported at 35.7% (Health Service Executive, 2021). Research supports the importance of breastfeeding beyond 12 months for infants and their mothers (Paul et al 2024). Suboptimal breastfeeding initiation and duration contributes to increased morbidity and mortality in children (Susiloretni et al. 2019). A number of breastfeeding mothers stop breastfeeding earlier than they had planned and this is a source of disappointment when breastfeeding goals are not reached. Enablers of breastfeeding exclusivity and duration include widespread cultural changes (Grant et al. 2022) and enhanced breastfeeding knowledge of healthcare professionals (McGuinness et al. 2024), including phrmacists.

The role of the Community Pharmacist

There is a growing team of interdisciplinary primary healthcare providers supporting families who breastfeed including general practitioners and general practice nurses (McGuinness et al. 2024). The community pharmacist has regular contact with pregnant and breastfeeding mothers and is in a key position to promote breastfeeding during the antenatal period and support mothers following birth to achieve their breastfeeding goals. The community pharmacist is a highly trained and trusted professional, notwithstanding the

accessibility and convenience of the community pharmacy with longer opening hours (Szabo et al. 2024). Furthermore, pharmacists expertise in medication management can support women who require medication advice while breastfeeding or expressing their breastmilk (Harahsheh et al. 2023). Post-partum mothers with acute and chronic illness will require medication and consult a pharmacist for advice while breastfeeding. While the majority of medications are safe to use during breastfeeding there are medications that are contraindicated or may affect a mother’s milk supply (Szabo et al. 2024).

We believe this is the first study to explore the breastfeeding and lactation knowledge, attitudes and training among Irish pharmacists which is essential to breastfeeding in Ireland. In turn this information will enhance further professional education and training for pharmacists.

Objective

The primary objective is to explore the knowledge, attitudes and training of community pharmacists in Ireland.

Method. This will be a cross –sectional, national study. A 28 item survey will be utilised to collect community pharmacist’s breastfeeding and lactation knowledge, attitudes and training in Ireland. The survey is a validated tool previously developed by Dr Dipa Kamdar, MPharm Kingston university, UK and we thank Dr Kamdar for permission to use this survey for our research among community pharmacists in Ireland. The survey was modified to the Irish context by pharmacists, a data analyst and International Board Certified Lactation Consultants (IBCLCs).

The survey tool will enable the researchers to collect demographic information, experiences, knowledge and training among community pharmacist’s related to lactation. The survey tool is divided into four sections: Demographic data, Education and Training, General knowledge about

breastfeeding and Pharmacists views. A comment box is provided at the end of the survey where community pharmacists can provide additional comments should they wish. We estimate the survey will take 10 minutes to complete.

An information leaflet and consent form will be available to read and sign prior to participating in the survey. Participation will be voluntary and there are no foreseeable risks to the community pharmacist’s participating. Participation is anonymous and results will be grouped and reported as an overall survey. Data will be analysed by an experienced data analyst.

Community pharmacists interested in participating in the research study will be able to access the survey via a link/QR code to the Qualtrics platform. This link will be available to every community pharmacist in Ireland via Irish Pharmacy News and we are most appreciative of the pharmacy magazine for providing this support with our research. We will also contact the following organisations to support recruitment and dissemination of the survey- the Irish Institute of Pharmacy, the Irish Pharmacy Union and the Pharmaceutical Society of Ireland. We appreciate the support of community pharmacists informing colleagues about this important study as we strive to support breastfeeding in Ireland.

If you would like further information please contact:

Denise Mc Guinness (Assistant Professor in Midwifery) and Niamh Vickers (Assistant Professor in Public Health Nursing), School of Nursing, Midwifery and Health Systems, University College Dublin.

Denise McGuinnessdenise.mcguinness@ucd.ie

Niamh Vickersniamh.vickers@ucd.ie

Ethics Approval - UCD Ethics Application is submitted and we await approval.

References available on request

Denise McGuinness Niamh Vickers

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Optimizing Infant Gut Health: The Role of BioGaia Protectis Baby Drops in Managing Common Gastrointestinal Issues

Gut health is fundamental to an infant’s overall development, influencing digestion, immunity, and even neurological function.

As healthcare professionals, pharmacists are often the first point of contact for parents seeking solutions for these common concerns. Evidencebased probiotic supplementation, such as BioGaia Protectis Baby Drops, provides a clinically validated, non-pharmacological approach to supporting infant gut health. These drops contain Lactobacillus reuteri DSM 17938, a probiotic strain with extensive research demonstrating its efficacy in reducing colic symptoms, promoting digestive regularity, and supporting overall gut function. The most clinically researched probiotic strain in the World for Infant Colic. Multiple award winning.

The Development of the Infant Gut Microbiome

The neonatal gut microbiome is established at birth and undergoes rapid maturation during the first few months of life. Several factors influence this development:

• Antibiotic exposure: Both maternal and infant antibiotic use can disrupt gut microbiota, reducing beneficial bacterial populations and increasing the risk of gastrointestinal symptoms

Written by Sinead FitzGerald, Owner, HappyTummy.ie

2. Constipation

• A common concern, particularly during dietary transitions (e.g., from breast milk to formula or the introduction of solid foods).

• Characterised by infrequent, hard stools and straining, infant constipation is often associated with altered gut motility and microbial imbalances.

3. Gastroesophageal Reflux (GER)

• Physiological reflux is common in infants due to an immature lower oesophageal sphincter. However, excessive or persistent reflux can cause discomfort, poor weight gain, and feeding difficulties.

3. Help Manage Infant Reflux

• Strengthens the gut barrier and modulates gastric emptying, potentially reducing regurgitation episodes.

• A study published in JAMA Paediatrics found that probiotic supplementation reduced GER symptoms in preterm infants.

Clinical Considerations and Recommendations for Pharmacists

• Feeding patterns: Breastfeeding supports microbiome colonization with beneficial bacteria and prebiotics, whereas formula feeding may lead to differences in microbial composition, so supplementation can be beneficial.

• Mode of delivery: Vaginal delivery exposes infants to maternal vaginal and gut microbiota. Studies prove that the microbiota become similar regardless of delivery method as the gut matures over time.

A well-balanced microbiome is essential for proper digestion, immune function, and gut motility. However, imbalances or dysbiosis may contribute to conditions such as infant colic, constipation, and reflux.

Common Infant Gastrointestinal Issues and Their Impact

1. Infantile Colic

• Defined as excessive crying (>3 hours per day, >3 days per week for at least 3 weeks), colic affects up to 20% of infants.

• Though its aetiology is multifactorial, gut microbiome dysbiosis, increased gas production, and gut immaturity are key contributors.

• Studies indicate that infants with colic have a higher abundance of pro-inflammatory gut bacteria and lower levels of beneficial Lactobacillus species.

• Gut microbiota alterations have been linked to increased gastrointestinal inflammation and motility issues, exacerbating reflux symptoms.

Probiotic supplementation presents a safe, evidence-based alternative for restoring gut balance and alleviating symptoms.

The Role of BioGaia Protectis Baby Drops in Infant Gut Health

BioGaia Protectis Baby Drops contain Lactobacillus reuteri DSM 17938, one of the most extensively studied probiotic strains in paediatric gastroenterology. This strain naturally colonizes the human gut and has been clinically proven to:

1. Reduce Colic Symptoms

• Randomized controlled trials (RCTs) demonstrate that Lactobacillus reuteri DSM 17938 reduces daily crying duration by up to 50% in colicky infants compared to placebo.

• The probiotic exerts its effects by modulating gut inflammation, improving gut motility, and reducing gas production.

2. Promote Regular Bowel Movements

• Increases stool frequency and softens stool consistency, aiding in the relief of functional constipation.

• Supports gut motility by promoting the production of short-chain fatty acids and improving microbial diversity.

As frontline healthcare providers, pharmacists play a key role in educating parents about the benefits of probiotic supplementation for infant gut health. When recommending BioGaia Protectis Baby Drops, consider the following:

• Safety profile: Suitable for use from birth, free from artificial additives, allergens, and preservatives. Over 250 published articles in key journals.

• Administration: 5 drops daily (directly into the mouth, on a spoon, or soother).

• Duration of use: Probiotic effects are cumulative; continued daily use is recommended for sustained benefits.

For infants experiencing persistent colic, constipation, or reflux, BioGaia Protectis Baby Drops represent a clinically supported, non-pharmacological intervention that can significantly improve symptoms and overall gut health thanks to containing Lactobacillus reuteri DSM 17938, and provide a scientifically validated approach to supporting microbiome balance, reducing colic symptoms, alleviating constipation, and mitigating reflux.

These probiotic drops offer a safe, effective, and evidence-based recommendation for parents seeking to improve their baby’s digestive health without the need for pharmaceuticals. With the additional option of Vitamin D supplementation, BioGaia ProTectis Baby Drops present a comprehensive solution for supporting early-life gut and immune system development.

Essential Nutritional Guidance for Infants: A Comprehensive Guide

for Parents and Pharmacists

Irish Pharmacy News recently spoke to Éva Hill Hamilton Clinical Nutritionist, to get her insights into what parents and community pharmacy teams should be aware of when it comes to nutrition in children and babies.

She told us, “The first year of life is a critical period for an infant’s growth and development. Proper nutrition during this time lays the foundation for a strong immune system, healthy digestion, and cognitive development. Pharmacists play an essential role in guiding parents through this journey, offering advice on breastfeeding, supplementation, and dietary choices. This article explores key nutritional needs for infants, common concerns, and best practices for ensuring optimal health.”

The Importance of Nutrition in the First Year

The first 1,000 days of life—from conception to a child’s second birthday—are crucial for normal development. “During this time, continuous support with essential nutrients is necessary, as certain developmental windows cannot be revisited later. Beyond simply focusing on calories. Aim to gradually transition to nutrient dense solid foods.” says Éva.

She adds, “Breast milk from a well-nourished mother provides a perfectly balanced combination of proteins, essential fats, and carbohydrates, along with immune-boosting factors that support a healthy gut microbiome. A strong gut microbiome is vital, as it influences digestion, immunity, and even brain function. Vaginal birth, skin-to-skin and breastfeeding promote the growth of beneficial Bifidobacterium species, which help maintain gut balance. Factors such as antibiotics, C-section delivery, early introduction of cow's milk and processed foods may impact the microbiome balance.

Éva Hill Hamilton, Clinical Nutritionist

“To support gut health, supplementation with live bacteria (probiotics)—particularly from the Bifidobacterium genus— along with Vitamin D3 should be considered from birth. Products such as VIVIO Junior Tummies Bifibaby Drops offer evidencebased support for an infant’s digestive and immune systems.”

Introducing Solid Foods and Essential Nutrients

At around six months, parents should gradually introduce a variety of solid foods while continuing to provide breast milk or age-appropriate formula. Éva noted that it is recommended to introduce new foods one at a time, with a three-day gap between introductions, to monitor potential allergic reactions.

Key Nutrients for Infant Growth

1. Iron: Essential for cognitive development and oxygen transport in the body. By six months, an infant's natural iron stores begin to deplete, so dietary sources become crucial. Haem-iron from meats is the most absorbable form and is best given alongside breastmilk and/or formula to enhance absorption. Fortified foods can help, but excessive dairy consumption should be limited, as it can interfere with iron absorption.

2. Long-chain Omega-3 fats (DHA): Critical for brain and vision development. Found in oily fish, nut and seed butters, and egg yolks. Baby fish oil supplements may be considered.

3. Vitamin D: Supports bone health and immune function. Since breast milk may not provide sufficient amounts, all breastfed infants should receive Vitamin D supplements, particularly in northern climates with limited sun exposure. Formula fed babies will receive Vitamin D through formula. Some parents may need support understanding Vitamin D supplementation levels.

4. Probiotics: Aid digestion and immune function.

Live bacteria, particularly Bifidobacteria, help maintain gut health and nutrient absorption.

The Role of Pharmacists in Infant Nutrition

Éva says, “Pharmacists are often the first point of contact for new parents seeking guidance on feeding, supplementation, and common infant health concerns. Their role extends beyond providing treatments to emphasizing preventative care through proper nutrition.”

Advising Parents on Essential Nutrients

Pharmacy teams should educate parents on:

• The importance of a balanced diet and appropriate supplementation for infants.

• Breastfeeding support and choosing nutrient-fortified, hypoallergenic formulas that closely resemble breast milk.

• Iron and Vitamin D supplementation, ensuring that products are free from preservatives and allergens, which can disrupt an infant’s sensitive gut lining.

• Practical weaning guidelines, including exposure to a variety of textures and flavors to encourage diverse eating habits.

Common Nutritional Concerns “Many parents seek advice about fussy eating, digestive issues, frequent infections, and concerns about their child’s growth. The most common nutrient deficiencies include iron, vitamin A, vitamin D, and zinc, all of which are essential for immune function. Picky eaters, in particular, may miss out on crucial nutrients due to diets high in processed foods and sugars. Pharmacists can guide parents in addressing these gaps by promoting a diverse diet and, if necessary, safe supplementation,” she highlights.

Caution with Over-the-Counter Supplements

“Not all supplements are suitable for infants,” Éva adds. “Safety should always be the top priority, and pharmacists should only recommend clinically tested, well-absorbed, and preservativefree formulations.”

• For infants under six months, fortified formula and safe probiotic and Vitamin D supplements are preferred.

• From one year onward, a highquality, preservative-free liquid

multivitamin may be added if dietary intake is inadequate.

When Should Parents Consider Supplementation?

Parents should seek professional advice if their baby:

• Struggles to gain weight or reach developmental milestones.

• Experiences frequent infections, digestive discomfort, or allergies.

• Shows signs of nutrient deficiencies, such as pale skin (iron deficiency) or weak bones (Vitamin D deficiency).

In such cases, a healthcare provider can assess the child’s diet and recommend targeted supplementation to support growth and immune function.

Best Sources of Key Nutrients

• Iron: Breast milk, fortified cereals, well-cooked meats, eggs, nut and seed butters.

• Omega-3 (DHA): Oily fish, egg yolks, nuts and seeds, fish oil supplements.

• Probiotics: Live bacterial supplements (e.g., VIVIO Junior Tummies Bifibaby Drops), fermented dairy (yogurt, kefir), and prebiotic-rich foods.

“During the weaning process, introducing a wide variety of plant and animal foods will help ensure a well-balanced diet. Continued probiotic supplementation can also support digestion and nutrient absorption.”

Final Thoughts

Éva concludes, “Ensuring optimal nutrition during infancy is crucial for lifelong health. Parents may be encouraged to focus on breastfeeding if possible along with gradual food diversification, and safe supplementation where needed, gradual food diversification, and safe supplementation where needed. Pharmacists play a key role in educating families and recommending appropriate nutritional strategies tailored to each child’s needs.

“By fostering early nutritional awareness and healthy eating habits, we can support better growth, immunity, and cognitive development in the next generation.”

References available on request

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Children and Gut Health

While great strides have been made in recent years in terms of public awareness around gut health in the adult population (albeit not where it needs to be in terms of diagnosis and destigmatisation), very little is spoken about when it comes to children and gut health.

Before delving into how gut health affects children and what the possible causes are, it’s important to look at the bigger picture first. It’s estimated around one in 10 people in Ireland have Irritable Bowel Syndrome (IBS), with the condition more than twice as common in women. IBS has myriad symptoms including cramping, bloating, diarrhea, constipation and sudden urges to use the toilet. It’s also believed a huge cohort of people with IBS symptoms have never had an official diagnosis, which can make day to day life even more distressing for sufferers as they try to find solutions and frequently feel dismissed or misunderstood.

Onset and / or diagnosis of IBS is common in early adulthood, but new research by PrecisionBiotics, the home of Alflorex, shows concerning trends of poor gut health in childhood. Looking specifically at this cohort, over half (61%) of parents surveyed said their children sometimes experienced gut issues, with the most common symptoms reported being bloating (20%), constipation (17%), and diarrhoea (21%).

These symptoms, while distressing at any age, can have a more profound effect on children as they navigate complex emotions and find it harder than adults to express how they feel. Added to their discomfort and pain is the fact that in general, children must ask for permission to use the toilet during class times in school.

The research shows that some of the main triggers of IBS in

Written by Dr Deirdre O’Donovan, Consultant Gastroenterologist, Blackrock Clinic Dublin

children are general anxiety (74%), while almost one in three parents surveyed (32%) cited not enough exercise, and just over one in four (26%) attributed insufficient sleep to the condition. When asked to what extent IBS influenced their child’s quality of life, just over one in 10 (11%) answered ‘a lot,’ while 47% said ‘somewhat.’ Dairy products fried and fatty foods, and large meals were the most common dietary triggers for the condition in children, according to the study.

Dr Deirdre O’Donovan, Consultant Gastroenterologist at Blackrock Clinic Dublin said: “Short lived bouts of diarrhea in children are not usually something to worry about and are generally caused by bugs they’ve picked up, but persistently liquid bowel movements need medical attention, as they can sometimes be a sign of something more serious going on with your child’s health, such as IBS, Crohn’s disease or ulcerative colitis. If a child has diarrhea for seven days or more, my advice would be to visit your GP.”

In terms of addressing gut health issues in children, the research has shown that awareness remains relatively low: only 44% of parents are confident they know what healthy gut function in a child should look like, 33% are not sure and 23% have no idea.

Dr O’Donovan explains that a healthy gut in children is not that different to how it represents itself in adults: “A child with a healthy gut should pass regular, solid bowel movements without pain

or discomfort. A trip to the toilet should not be a cause of worry or distress in a child, and if they seem to be upset about going to the bathroom or if their teacher is reporting issues in this regard, it might be time to investigate what’s going on.”

Looking at potential reasons for poor gut health in children, the answers appear, in part, to lie in an imbalance in the gut microbiome: A recent meta-analysis paper52 including 12 key studies, concluded that microbiome diversity and richness can be influenced by children’s antibiotic use, which leads to shifts in the amount of valuable good bacteria living in their gut. The research by PrecisionBiotics also shows that constipation can also affect as many as 1 in 4 (24%) children, with microbiota now thought to influence peristalsis - intestinal contractions that promote the movement of food through the gut.

Dr Deirdre O’Donovan added: “This research around children’s gut health underlines the need for more education and awareness in this area. However, simple steps make a huge difference, such as creating a good routine around meal times and bed time, and ensuring a child’s diet is rich in fruit and vegetables which provide a source of fibre. It’s also

important to encourage children to eat slowly to aid digestion. While there are times when antibiotic use in children cannot be avoided, such as to treat infections, preventative measures can help reduce use and should in turn have a positive effect on your child’s gut. A clinically proven child-friendly probiotic such as Alflorex Children for over 3 years old could also be considered to help balance the gut microbiome. It’s also important to watch out for signs of stress in your child, and to explore any possible underlying reasons for this. There have been huge strides in recent years in understanding the gut / brain axis and we now know that mental and physical health go hand in hand.” Alflorex® Children has all the benefits of the scientifically studied Bifidobacterium longum 35624™ strain in a convenient and reliable dissolvable powder form that has a hint of vanilla. Each sachet of Alflorex® Children is packed with 1 x 10™ bacteria proven to reach the gut in peak condition. Suitable for Children over 3 years.

Sources:

Perspectus Global 2025 PrecisionBiotics Omnibus Survey. N=1007 Nat. Rep. ROI

https://pubmed.ncbi.nlm.nih. gov/33651651

Continuing Professional Development

60 Second Summary

Rheumatoid arthritis (RA) is a common inflammatory arthritis affecting 1% of the population. While joint manifestations may be the most visible issue, it is a true systemic disease affecting multiple organs and systems. Characteristic symptoms include early morning stiffness, and pain and swelling in the small joints of the hands and feet. Interstitial lung disease affects 8% of people with RA and is associated with significant reduced survival. Inflammatory markers (ESR and CRP) are generally elevated in RA, but may be normal.

25% of patients will be negative for both rheumatoid factor and CCP antibody. Many individuals with a positive rheumatoid factor in particular do not have RA.

Methotrexate is the first line treatment and anchor drug for other treatment strategies. A wide range of treatments are now available for RA collectively called disease-modifying antirheumatic drugs (DMARDS). These include conventional synthetic DMARDS such as leflunomide, sulfasalazine, and hydroxychloroquine, biologic DMARDS such as TNF inhibitors, interleukin-6 inhibitors, and B and T cell affecting agents, and the JAK inhibitors.

Combination treatment strategies are generally employed if methotrexate is insufficient. The ability to identify the correct medication for an individual patient a priori remains an elusive goal.

AUTHOR: by Professor Richard Conway, Consultant Rheumatologist, St. James Hospital; Clinical Associate Professor, Trinity College Dublin Richard Conway graduated from the Royal College of Surgeons in Ireland in 2006. He completed rheumatology and general internal medicine training in Ireland in 2014, and a PhD in giant cell arteritis at University College Dublin in 2017. He is currently a consultant rheumatologist and physician at St. James’s Hospital and a clinical associate professor at Trinity College Dublin. He is the author of more than 200 peer-reviewed publications and 4 book chapters. His research interests include interstitial lung disease in systemic rheumatic diseases, polymyalgia rheumatica, and systemic vasculitis.

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

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

3. PLAN - If I have identified a

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

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

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

4 previous steps, log and record your findings.

Published by IPN. Copies can be downloaded from www.irishpharmacytraining.ie

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Update on Rheumatoid Arthritis

Case Study

A 32 year old female presented with a 3 month history of pain and swelling in her hands and feet. She reports a progressive increase in symptom severity. Initially they were stiff and sore for the initial hour after rising in the morning but now this has extended through until the afternoon. On examination she has tender swollen metacarpophalangeal and proximal interphalangeal joints in her hands and is sore and swollen across the balls of both feet. Initial bloods tests show an elevated C-reactive protein of 31 mg/L and erythrocyte sedimentation rate of 45 mm/hr. She has positive rheumatoid factor of 65 IU/ml and anti-cyclic citrullinated peptide antibodies >340. Plain radiographs of her hands and feet are reported as normal. She is diagnosed with seropositive rheumatoid arthritis and commenced on treatment with methotrexate 10mg a week and folic acid 5mg a week. She was also prescribed a prednisolone taper of 20mg daily for a week, 15mg daily for a week, 10mg daily for a week, 5mg daily for a week, and then stopping. She was referred to a clinical nurse specialist for disease and medication education, and to an occupational therapist for a joint protection programme. A review was planned for 6 weeks time.

Epidemiology

Rheumatoid arthritis is a chronic systemic inflammatory disease affecting 1% of the population of the developed world. It is 2-3 times as common in women than men. Joint manifestations are frequently the first and most evident symptom; however it is a true systemic inflammatory condition affecting multiple organs. Of these an increase in cardiovascular disease equivalent to that seen with type 2 diabetes mellitus, and the occurrence of interstitial lung disease in 8% of patients represent the most significant problems. Due mainly to these factors, untreated rheumatoid arthritis is associated with a significant increase in mortality. Appropriate treatment decreases this risk.

Symptoms

Rheumatoid arthritis has classically been described as a symmetrical deforming polyarthritis. In modern rheumatology practice this classical aphorism no longer holds true. Our goal is to diagnose and treat rheumatoid arthritis as early and aggressively as needed to eliminate symptoms. It is distinctly unusual in modern rheumatology to see a patient diagnosed since the advent

of biologic therapies develop significant deformities.

In the early stages of rheumatoid arthritis the disease is not always symmetrical nor affecting a large number of joints and this will only develop with untreated progressive disease, a failure of treatment. New onset rheumatoid arthritis therefore can present as an oligo or even mono-arthritis, and may be asymmetrical.

Joint pain and swelling is the cardinal feature of rheumatoid arthritis, but can also be caused by a multitude of other conditions. In rheumatoid arthritis the small joints of the hands and feet are characteristically affected but large joints and the cervical spine may also be involved. The lower back and distal interphalangeal joints in the hands are classically spared in rheumatoid arthritis. Joint stiffness on first walking in the morning (early morning stiffness) is characteristic of inflammatory arthritis, this typically also improves with activity. All of us can be a little creaky on first waking, a duration of at least 30 minutes is normally considered significant. Patients with osteoarthritis consistently do also have early morning stiffness, but with a duration of minutes rather than hours. A patient with hand osteoarthritis will typically

42 CPD: Rheumatoid Arthritis

identical, in the early stages. The diagnosis of inflammatory arthritis as a collective group, or any of the individual conditions, is made by clinician gestalt. There are no diagnostic criteria or definitive tests available. A number of different classification criteria have been published for these diseases; the purpose of these is to provide a homogenous patient cohort for research purposes, they perform poorly when used for diagnosis and should not be used for such.

report being worse first thing in the morning and it is crucial to elucidate the specific duration before attributing this to an inflammatory arthritis.

The key clinical examination finding of rheumatoid arthritis is synovitis, a boggy, usually (but not always) tender, swelling in the joints. This is distinct from the hard bony swelling (nodes) seen in osteoarthritis. Due to the multi-system nature of the disease patients may also present with symptoms from other organs, the most common of these are dry gritty eyes, exertional dyspnoea and dry cough.

Diagnosis

Given that our aim is to diagnose and treat rheumatoid arthritis before the development of its textbook manifestations, the question then becomes how does one diagnosis early rheumatoid arthritis and differentiate it from other types of arthritis? This may sometimes be difficult, but in fact is often not that important; the key

question is not whether the patient has rheumatoid arthritis or not, but whether they have an inflammatory arthritis or not. Inflammatory arthritis comprises a group of conditions, the most common of which are rheumatoid arthritis, psoriatic arthritis, and reactive arthritis, although there are many others. Importantly, the treatment of these is broadly similar, if not identical, in the early stages. The diagnosis of inflammatory arthritis as a collective group, or any of the individual conditions, is made by clinician gestalt. There are no diagnostic criteria or definitive tests available. A number of different classification criteria have been published for these diseases; the purpose of these is to provide a homogenous patient cohort for research purposes, they perform poorly when used for diagnosis and should not be used for such.

A number of factors increase the likelihood of a patient having inflammatory arthritis and are factored into the clinical diagnosis. Early morning stiffness for greater

than 30 minutes is a strong indicator of an inflammatory condition. The presence of synovitis (soft boggy swelling) is a good predictor but requires experience to appreciate, especially in subtle cases. Elevated acute phase reactants (C-reactive protein, erythrocyte sedimentation rate) do increase the likelihood of an inflammatory arthritis but should not be relied on as they can be normal in the presence of rheumatoid arthritis, and indeed elevated in its absence. Radiographic erosions, while typically seen in advanced rheumatoid arthritis, should not commonly be encountered in modern presentations. Rheumatoid factor and anti-cyclic citrullinated peptide antibodies are not useful in diagnosing inflammatory arthritis. They are useful in characterising a patient with inflammatory arthritis as seropositive rheumatoid arthritis. However, if they are used in unselected patients with joint pain they are more likely than not to reveal false positives.

Treatment

Many textbooks still place nonsteroidal anti-inflammatory drugs (NSAIDs) as the first line treatment of rheumatoid arthritis. This is incorrect. These drugs provide some symptomatic relief but are insufficient for the vast majority of patients with rheumatoid arthritis and risk delaying the institution of definitive effective treatment. They are also associated with common, potentially severe adverse events when used chronically (and rheumatoid arthritis is a chronic incurable condition).

A number of factors increase the likelihood of a patient having inflammatory arthritis and are factored into the clinical diagnosis. Early morning stiffness for greater than 30 minutes is a strong indicator of an inflammatory condition. The presence of synovitis (soft boggy swelling) is a good predictor but requires experience to appreciate, especially in subtle cases. Elevated acute phase reactants (Creactive protein, erythrocyte sedimentation rate) do increase the likelihood of an inflammatory arthritis but should not be relied on as they can be normal in the presence of rheumatoid arthritis, and indeed elevated in its absence. Radiographic erosions, while typically seen in advanced rheumatoid arthritis, should not commonly be encountered in modern presentations. Rheumatoid factor and anti-cyclic citrullinated peptide antibodies are not useful in diagnosing inflammatory arthritis. They are useful in characterising a patient with inflammatory arthritis as seropositive rheumatoid arthritis. However, if they are used in unselected patients with joint pain they are more likely than not to reveal false positives.

Methotrexate is the first line and anchor drug (in combination strategies) in rheumatoid arthritis. Its regularly attributed mode of action of folate antagonism is too simplistic and we do not fully understand its effect in rheumatoid arthritis. It is however remarkably effective. Concerns have existed over potential adverse events, however high quality research studies in recent years have shown that these are largely unfounded, and that methotrexate is a far

Musculoskeletal Pain

Treatment

Many textbooks still place non-steroidal anti-inflammatory drugs (NSAIDs) as the first line treatment of rheumatoid arthritis. This is incorrect. These drugs provide some symptomatic relief but are insufficient for the vast majority of patients with rheumatoid arthritis and risk delaying the institution

Figure 1: Diagnostic algorithm in new musculoskeletal pain

safer treatment than NSAIDs or glucocorticoids. Indeed, methotrexate treatment is far safer than having active untreated rheumatoid arthritis; rheumatoid arthritis is associated with a significant increase in mortality above the general population. Methotrexate use is associated with a 70% reduction in mortality in rheumatoid arthritis. The starting dose of methotrexate is 10 to 15mg once a week, this is combined with folic acid 5mg at least once a week to prevent adverse events. The dose can be up-titrated at 3-monthly intervals until control is achieved, for most patients a weekly dose of 20-25mg is not exceeded. Methotrexate is most commonly initially prescribed orally but subcutaneous formulations have the potential for better bioavailability and reduced adverse events.

A number of other diseasemodifying anti-rheumatic drugs (DMARDs) are also used. Commonly used DMARDs include sulfasalazine, hydroxychloroquine, and leflunomide. These can be utilised either instead or in combination with methotrexate. Triple therapy, consisting of methotrexate, sulfasalazine, and hydroxychloroquine appears to have efficacy close to that of the more expensive biologic agents.

If patients continue to experience significant symptoms despite DMARD treatment the usual next step is to add in a biologic medication. In a general sense, these agents work by targeting a specific component of the aberrant immune-inflammatory response in rheumatoid arthritis. Because they are specifically designed medications, they less frequently cause adverse events than traditional DMARDs, albeit when

Future treatments

these (predominantly infection related) adverse events occur they are more serious. There are multiple agents now available; these include tumour necrosis factor inhibitors (etanercept, adalimumab, infliximab, golilumab, certolizumab), interleukin-6 inhibitors (tocilizumab), B-cell depleting agents (rituximab), T-cell modulators (abatacept), and janus kinase inhibitors (tofacitinib, baricitinib, upadacitinib, filgotinib). Less expensive (but equally effective) equivalents of the originator biologic agents, termed biosimilars, are now available. All of these agents require careful pre-assessment for latent infections (tuberculosis, viral hepatitis) and other contraindications and cautions prior to their use. These agents are life-changing for many patients, but must be started and monitored in the appropriate setting.

All of the available DMARD and biologic treatments for rheumatoid arthritis take a number of months for a full effect to be seen; we do not evaluate treatment response until after 3 months for this reason. Rheumatoid arthritis is frequently a profoundly symptomatic condition and patients may suffer significantly while waiting for treatment to take effect. This is where there is a role for glucocorticoid treatment in the short term. Glucocorticoids are a remarkably effective treatment for rheumatoid arthritis but associated with significant adverse events, particularly in the long term. A short course of glucocorticoids (steroid taper), however is generally safe and can dramatically improve a patient’s symptoms.

Figure 2: RA management algorithm

Figure 3: Prednisolone taper for active RA

44 CPD: Rheumatoid Arthritis

There are many ways of utilising this steroid taper, the author’s preference is to give 20mg prednisolone daily for a week, 15mg daily for a week, 10mg daily for a week, 5mg daily for a week, and then stop.

Future treatments

It is very likely that new treatments for rheumatoid arthritis, especially biologic agents and biosimilars, will continue to enter the market. It is less likely that any of these will prove to be significantly more efficacious than others. This is due to the inherent complexities of rheumatoid arthritis. It is increasingly recognised that rheumatoid arthritis is not one “disease”, rather it is a heterogenous mix of related conditions with a similar phenotype. The molecular basis for the initiation and continuation of inflammation is different for different groups of patients with the disease. Even within the same patient, multiple cytokines are involved in the inflammatory process, to a greater or lesser extent. The clinical implication of this is that in each individual patient some medications, and particularly biologic agents, are more likely to work than others. At present we are essentially unable to identify which agent is most likely to work a priori. The ability to do so is the holy grail of treatment in rheumatoid arthritis, termed personalised medicine. Extensive efforts have been underway in this field for a number of years with no great progress to date. Again, this likely relates to the complex and heterogenous nature of the disease. It is hoped that this will change in the future and we will enter an era where we can offer patients an initial treatment for “their” rheumatoid arthritis.

Interstitial Lung Disease in Rheumatoid Arthritis

Pulmonary disease is the second most cause of mortality in RA. While a plethora of pulmonary manifestations have been described in RA the most serious, and unfortunately one of the more frequent is RA related interstitial lung disease (RA-ILD).

The burden of RA-ILD has been difficult to fully ascertain. The seminal cohort study reported a lifetime risk of 7.7% for ILD in RA

patients compared to 0.9% for ILD in the general population. More recent studies have reported the development of incident RA-ILD in 3-5% of RA patients over shorter follow up periods. All of these studies evaluated symptomatic RA-ILD, which is the key clinically relevant question. Screening for RA-ILD in asymptomatic patients reveals a far greater prevalence. Exact figures depend on the methodology and diagnostic thresholds used but can be up to 67% of RA patients screened with CT thorax and 80% of those histologically screened. It would not be an unreasonable interpretation of these numbers to suggest that all RA patients have some degree of ILD if one looks hard enough, again reflecting the true systemic nature of the disease process. The clinical relevance of the identification of such asymptomatic cases is less certain, however.

A number of key features of RA development suggest that the lung may be a primary site of the initiation and propagation of RA. These include the association with smoking, the pulmonary manifestations of RA, and the finding of citrullinated antibodies in early and pre-RA disease. Identified risk factors for the development and subsequent severity of RA-ILD include age, male sex, disease activity, smoking, and seropositivity for rheumatoid factor or anti-cyclic citrullinated peptide antibodies. The gain-of-function MUC5B promoter variant rs35705950 which was first described in IPF is also associated with the development of RA-ILD.

While generally occurring in a patient with known RA, RA-ILD may also occur in patients with joint pain but no formal diagnosis of RA, and more less commonly as the first manifestation of rheumatoid disease in a patient with no prior or contemporary joint based symptoms. RA-ILD may be clinically silent for many years and most commonly presents with an insidious onset of symptoms. This can be further exacerbated by the functional limitations of the articular disease limiting recognition of incipient exertional dyspnoea. More rarely it can present as a fulminant ILD process reminiscent of the Hamman-Rich

syndrome. The characteristic presentation of RA-ILD is with slowly progressive exertional dyspnoea and dry cough. Fine bibasal crepitations on lung examination and finger clubbing are common but are generally not identifiable until later in the disease course. The radiologic findings of RA-ILD most commonly resemble IPF with a usual interstitial pneumonia (UIP) most common, other patterns such as non-specific interstitial pneumonia (NSIP) can occasionally be seen.

The optimum management of RAILD remains uncertain. It makes intuitive sense that controlling the rheumatoid disease process itself would be a central pillar of any management strategy. There is good evidence that increased RA disease activity is related to the development and progression of RA-ILD. One of the difficulties we have in ascertaining RA disease control is that all of our existing measures are heavily weighted towards arthritis measures. Our contemporary understanding of RA as a pansystemic disease implies that we require measures encompassing non-articular disease activity measures to ensure appropriate disease control in all patients. Methotrexate is our first line and anchor drug for the management of rheumatoid arthritis. The previous implication of methotrexate as a contributory agent to the development of RAILD has been comprehensively shown to be erroneous.

Methotrexate is associated with a very rare acute pneumonitis but this is entirely distinct from RA-ILD. In fact, methotrexate appears to be protective for both the development and progression of RA-ILD, mirroring its efficacy in articular disease. Our evidence for the use of specific biologic disease-modifying antirheumatic drugs, which have become central to the management of severe RA, is lacking due to a dearth of randomised controlled trials. There is some evidence that rituximab and abatacept, rather than TNF-inhibitors, may be the agents of choice in the setting of RA-ILD. The use of these agents in observational studies has been reported to halt disease progression in the majority of treated patients. The evidence to support this remains limited,

however given their equivalent efficacy in RA generally it appears reasonable to use them as the biologics of choice in RA patients with ILD. A complementary strand to management has been opened with the advent of anti-fibrotic agents, with nintedanib being shown to have equivalent efficacy in RA-ILD as was previously demonstrated in idiopathic pulmonary fibrosis.

The natural history of clinically relevant symptomatic RA-ILD appears to be one of inexorable progression. The median survival from diagnosis in historic cohorts is 2.6 years. The natural history of asymptomatic RA-ILD appears to be frequently more benign and may not progress in many patients, although this requires further confirmation. Observational study evidence of abatacept and rituximab suggests that these agents may be able to arrest RA-ILD disease progression in the majority of patients. Anti-fibrotic agents appear to be associated with continued disease progression but they decelerate this evolution. Pulmonary fibrosis is the end stage result of the inflammatory pulmonary process inherent in RA. As a general rule, established pulmonary fibrotic change is not readily reversible. It is theorised that early aggressive intervention encompassing complete RA disease activity suppression, perhaps in combination with specific therapeutic agents may lead to greatly improved outcomes by intervening prior to the development of this irreversible lung damage. Such a strategy while theoretically appealing, requires to be proven.

Conclusion

Rheumatoid arthritis is a common severe systemic inflammatory disease. Early diagnosis and prompt treatment are key to improving patient’s symptoms and prognosis. Early institution of methotrexate treatment with aggressive treatment escalation to achieve disease remission achieves optimum outcomes. In those with severe rheumatoid arthritis, the ability to predict which biologic agent is best for each individual is a crucial goal of current research.

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Generic Product Launch

Pomalidomide Teva

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pomalidomide

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High Tech Prescription Only Medicine

Indications

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

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

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

Pomalidomide Teva Abbreviated Prescribing Information

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

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.

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

pomalidomide with 20mg to 40mg dexamethasone (a weak to moderate inducer of several CYP enzymes including CYP3A) to patients with multiple myeloma had no effect on the pharmacokinetics of pomalidomide compared with pomalidomide administered alone. Pregnancy and lactation: Patients of childbearing potential should use effective method of contraception. If pregnancy occurs in a patient treated with pomalidomide, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice. If pregnancy occurs in a partner of a male patient taking pomalidomide, it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice. Pomalidomide is present in human semen. As a precaution, all male patients taking pomalidomide should use condoms throughout treatment duration, during dose interruption and for 7 days after cessation of treatment if their partner is pregnant or of childbearing potential and has no contraception. A teratogenic effect of pomalidomide in humans is expected. Pomalidomide is contraindicated during pregnancy and in patients of childbearing potential, except when all the conditions for pregnancy prevention have been met. It is unknown whether pomalidomide is excreted in human milk. Because of the potential for adverse reactions in breastfed infants from pomalidomide, a decision must be made whether to discontinue breast-feeding or to discontinue the medicinal product, taking into account the benefit of breast-feeding for the child and the benefit of the therapy for the patient. Effects on ability to drive and use machines: Pomalidomide has minor or moderate influence on the ability to drive and use machines. Fatigue, depressed level of consciousness, confusion, and dizziness have been reported with the use of pomalidomide. If affected, patients should be instructed not to drive cars, use machines or perform hazardous tasks while being treated with pomalidomide. Adverse reactions: Pneumonia, bronchitis, upper respiratory tract infection (including viral), sepsis, septic shock, neutropenic sepsis, C. difficile colitis, bronchiolitis, urinary tract infection, herpes zoster, hepatitis B reactivation, basal cell carcinoma, squamous cell carcinoma of the skin, neutropenia, thrombocytopenia, leucopenia, febrile neutropenia, pancytopenia, angioedema, anaphylactic reaction, solid organ transplant rejection, hypothyroidism, hypokalaemia, tumour lysis syndrome, syncope, depressed level of consciousness, intracranial haemorrhage, cerebrovascular accident, cataract, atrial fibrillation, cardiac failure, myocardial infarction, deep vein thrombosis, gastrointestinal haemorrhage, hyperbilirubinaemia, hepatitis, DRESS, TEN, SJS, acute kidney injury, renal failure. Very Common: Influenza, anaemia, hyperglycaemia, decreased appetite, insomnia, peripheral sensory neuropathy, dizziness, tremor, dyspnoea, cough, diarrhoea, vomiting, nauseas, constipation, abdominal pain, rash, muscular weakness, back pain, muscle spasms, fatigue, pyrexia, peripheral oedema. Common: Bronchopneumonia, respiratory tract infection, lower respiratory tract infection, lung infection, nasopharyngitis, lymphopenia, urticaria, hypomagnesaemia, hypocalcaemia, hypophosphataemia, hyperkalaemia, hypercalcaemia, hyponatraemia, hyperuricaemia, depression, confusional state, peripheral sensorimotor neuropathy, paraesthesia, dysgeusia, vertigo, hypotension, hypertension, pulmonary embolism, epistaxis, interstitial lung disease, upper abdominal pain, stomatitis, dry mouth, abdominal distention, pruritus, bone pain, chronic kidney injury, urinary retention, non-cardiac chest pain, oedema, fall, alanine aminotransferase increased, weight decreased, neutrophil count decreased, white blood cell count decreased, platelet count decreased, blood uric acid increased. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: Pomalidomide doses as high as 50mg as a single dose in healthy volunteers have been studied without reporting serious adverse reactions related to overdose. Doses as high as 10mg once-daily multiple doses in multiple myeloma patients have been studied without reported serious adverse reactions related to overdose. The dose-limiting toxicity was myelosuppression. In studies, pomalidomide was found to be removed by haemodialysis. In the event of overdose, supportive care is advised. Legal category: POM. Marketing Authorisation Number: EU/1/24/1868/001048. Marketing Authorisation Holder: TEVA GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany. Job Code: MED-IE-00090. Date of Preparation: January 2025.

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

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

Further information is available on request or in the SmPC. Product Information also available on the HPRA website. Date of Preparation: January 2025 | Job Code: GEN-IE-00124

Irish Pharmacy Awards 2025

Recognising the importance of continued knowledge, education and sharing of information amongst the pharmacy profession

Ireland’s ‘Most Trusted’* pharmacy publication - Irish Pharmacy News - are delighted to announce the launch of the annual Irish Pharmacy Awards 2025

Now is the time to recognise that dedication.

The Irish Pharmacy Awards 2025 will be a celebration of success and also a platform of gratitude to community pharmacists and their teams. The awards recognise excellence and innovation and this is the premier opportunity for the industry to show their appreciation.

We look forward to welcoming you all to Clayton Hotel, Burlington Road, Dublin on Saturday, 24th May 2025

 Haleon Self-Care Award

 United Drug Business Development (Independent) Award

 Perrigo Superintendent Pharmacist of the Year

 Reckitt Community Pharmacist of the Year

 Uniphar Training & Development Award

 PKF Brenson Lawlor Young Community Pharmacist of the Year

 Excellence in Technology Award

 OTC Counter Assistant of the Year

Entries are now open: Applications can be downloaded from www.irishpharmacyawards.ie

 BOI Payment Acceptance (BOIPA) Innovation & Service Development (Chain) Award

 Athlone Pharmaceuticals Community Pharmacy Team of the Year

 McLernons Independent Community Pharmacy of the Year

 Alliance Community Pharmacy Technician of the Year

 Clonmel Healthcare Customer Service Award (3+ Pharmacies)

Closing Date for Entries: Friday, April 11th, 2025 For an Entry Form Contact: Kelly Jo Eastwood on: Mobile: 0044 787654 8989 Email: kelly-jo@ipn.ie

BOOK YOUR TABLE

Over 650 of Ireland’s pharmacy industry professionals will join us on Saturday, May 24th 2025 at the Clayton Hotel (Burlington Road) Dublin. Don’t miss out on this opportunity to network and celebrate community pharmacy. This is sure to be a night to remember. Seats and tables are filling up fast. Book your table now to attend Ireland’s premier Pharmacy Awards event. Contact Kelly Jo Eastwood via email: kelly-jo@ipn.ie

OTC Counter Assistant of the Year Award 2025

Pharmacists are widely recognised for their invaluable work in the community. But what about the rest of the team? All of the team and especially the counter staff play a critical role in the success of the pharmacy and the service it provides.

Perhaps you are a counter assistant, or know of one who has made a huge impact within their local pharmacy around customer care, delivering health promotion activities or forging links with the local community. Or you/they might have improved safety or efficiency in the dispensing process, taken on delivery of clinical services or management responsibilities, or mentored colleagues.

How to Enter:

The OTC Counter Assistant of the Year Award recognises excellence in knowledge and service to retail customers. Nominations for the category can be made through self-nomination, by colleagues or by pharmacy business owners. Judges will be looking to reward those who bring something extra to the consumers experience of the pharmacy setting within a community.

Awards Criteria:

1. Clear demonstration of how the nominee/counter assistant has successfully placed customer care at the forefront of their pharmacy.

2. The details and rationale for any specific initiatives developed by the nominee for customer care.

3. Levels of excellence displayed above and beyond that expected from a counter assistant role.

4. Clear evidence of team working and excellent communication between the individual, their peers/colleagues and their patients and local community.

BOI Payment Acceptance (BOIPA) Innovation & Service Development (Chain) Award 2025

* Open to all pharmacies with more than 3 stores

The Innovation & Service Development Award’s principal aim is to reward innovation within the community pharmacy sector. The judging panel will be looking for ways in which a project is both innovative and successful.

This Award identifies individuals and teams working within multiple community pharmacies in Ireland whose ideas or inventions have, or could lead to, improvement in the patient experience in all areas of care throughout their community.

How to Enter:

Applications are sought from those demonstrating clear enthusiasm and commitment to the enhancement of community pharmacy in Ireland, exceptional quality above and beyond what is expected and an ability to overcome challenges in pursuit of goals.

Awards Criteria:

1. Activities that may involve pioneering new models or systems that improve pharmacists’ impact as members of the healthcare team; patient safety and outcomes; patient care in general and other professional development.

2. Development of a system or tool for pharmacy that will directly or immediately impact patient care or the profession and/or serve as an example or template for other pharmacy professionals to follow.

3. Measurable benefits of your initiative. Please use financial data wherever possible (percentages, rations, graphic images etc.), as well as other statistics to show how your project has bought added value, profits, customer satisfaction improvements, productivity increases or any other benefit relevant to this award category.

Applications Close - Friday, April 11th, 2025 Send your entries to - kelly-jo@ipn.ie Download application forms from: https://irishpharmacyawards.ie/

United Drug Business Development (Independent) Award 2025

* Open to all pharmacies with less than 3 stores

The United Drug Business Development (Independent) Award serves to recognise those who have displayed success in terms of sales, training, recruitment, customer service, product development or other areas of business development.

Entries should demonstrate an innovative approach to creating new business, and outline the timescales, objectives and results of the initiative.

How to Enter:

Judges will look for a business initiative that stands out in terms of its scale, scope or approach. This award will credit the company that has demonstrated excellent levels of customer service backed by clear standards and adequate monitoring performance.

Awards Criteria:

1. Clear demonstration of an identified need and personal rationale along with details of the process of implementation from concept to design, planning and results.

2. Evidence will be displayed for plans for further research and development.

3. Evidence of a sound business plan, sales and marketing strategies.

4. Strong leadership skills with the ability to drive the business forward Innovation and ambition.

Clonmel Healthcare Pharmacy Customer Service Award 2025

* Open to all pharmacies with more than 3 stores

This is a New category for 2025. The Clonmel Healthcare Pharmacy Customer Service Award recognises outstanding commitment to delivering exceptional customer service in a community pharmacy setting.

It celebrates pharmacies, teams, or individuals who go above and beyond to enhance the patient experience, ensuring accessibility, compassion, and professionalism in pharmacy services.

This Award Category is open to all chain community pharmacies demonstrating excellence in customer service. The initiative or service improvements must have been implemented within the past two years and show measurable impact.

How to Enter:

Entries must showcase a strong commitment to patient-centred care, innovation in service delivery, and positive customer feedback.

Mystery Shopper Assessment:

As part of the judging process, a mystery shopper element will be incorporated. Mystery shoppers will visit shortlisted pharmacies to assess the quality of customer service, including friendliness, professionalism, attentiveness, and problem-solving skills. The results of this assessment will contribute to the final judging decision.

Awards Criteria:

Judges will be looking for:

1. Outstanding Patient Care and Compassion: Evidence of personalised, empathetic, and proactive customer service that enhances the patient experience.

2. Innovation in Service Delivery: Creative approaches, new initiatives, to improve customer interactions and accessibility.

3. Proven Impact and Customer Feedback: Measurable improvements in customer satisfaction, supported by testimonials, reviews, or survey results.

4. Commitment to Continuous Improvement: Ongoing staff training, service enhancements, and efforts to maintain high standards of patient care.

Applications Close - Friday, April 11th, 2025 Send your entries to - kelly-jo@ipn.ie

Download application forms from: https://irishpharmacyawards.ie/

McLernons Independent Community Pharmacy of the Year Award 2025

This Award Category is open to all pharmacies with 3 or less stores. The McLernons Independent Community Pharmacy of the Year Award seeks to recognize excellence within the independent community pharmacy sector.

Independent pharmacies across Ireland have long been the backbone of community services, but must continuously look for new ways to be innovative, delivering high quality patient care and pharmacy offerings to rival the increasingly competitive force of the larger multiples and chain stores.

The judging panel will be looking for ways in which entries are both innovative and successful.

This Award identifies pharmacy stores and their teams who have demonstrated dedication towards their customer-base in all areas of care throughout their community.

How to Enter:

Applications are sought from those demonstrating clear enthusiasm and commitment to the Independent community pharmacy business in Ireland, exceptional quality above and beyond what is expected and an ability to overcome challenges in pursuit of goals.

Awards Criteria:

1. Measurable benefits your pharmacy has brought to the community; with evidence to show how you have brought added services or value to your customers; productivity increases or other benefits relevant to this Award.

2. Evidence of strong team working, clear goals and achievements.

3. Demonstration of how your independent pharmacy has had an impact on the community its serves.

4. Evidence of how your way of working, within an independent, rivals the larger multiple stores to bring the same benefits to patients.

Introducing...

Haleon Self-Care Award 2025

The Haleon Self-Care Award recognises community pharmacy’s commitment to tackling health inequalities and serves to reward achievement in the development and implementation of health promotion, self-care and community wellbeing strategies/initiatives. It is designed to encourage excellence in the production and dissemination of accessible, well-designed and clinically balanced patient support.

How to Enter:

The Award will be presented to the team or individual who can demonstrate a significant positive impact on the experience of those who use Pharmacy services. This may be through campaigns, promotions or initiatives which have identified a need within the community to address certain health issues.

Awards Criteria:

1. Evidence of long-term, consistent dedication and outstanding achievements that have led to the advancement of the profession of pharmacy and self-care.

2. Evidence of how you/your team have researched and identified a need within the self-care market and how you have met this need for the enhancement of patient care.

3. Examples of entries may include evidence of the impact your self-care offering has had on the community you serve/ improved your links with allied healthcare professionals or organisations and/or tackled a health inequality through self-care initiatives and promotions.

Close - Friday, April 11th,

Send your entries to - kelly-jo@ipn.ie

Haleon, formerly part of GSK

Uniphar Training & Development Award 2025

The Uniphar Training & Development Award will recognise an outstanding pharmacy individual, team or project that has made significant contribution to the education, training and development of the profession in Ireland. Judges will be looking for innovative practice, across projects that may have upskilled a pharmacy team, led to an increase in productivity, or motivated and inspired peers and colleagues.

Perhaps you’ve developed an innovative training programme to upskill your team(s)? Maybe you’ve introduced an initiative to celebrate your best-performers that has led to an increase in productivity? Or are you a trainee pharmacist tutor who has found new ways to inspire and motivate their trainees to reach their full potential? The judges will want to see how you have put your people and their skills at the heart of what you do and the impact this has had on the business and your patients.

How to Enter:

Judges will be looking for pharmacies that can showcase a commitment to cultivating exceptional skills and that can demonstrate a positive impact on business goals and a return on investment.

Awards Criteria:

1. Evidence of training, education and/or support initiatives undertaken by the pharmacist/pharmacy team.

2. Demonstration of how your training and development initiative(s) developed, utilised and/or motivated your pharmacy team(s).

3. An ability to show what impact your training and development initiative(s) had on patients.

4. Examples of how this training and development initiative has impacted your pharmacy/ies.

Excellence in Technology Award 2025

A new category for 2025, the Excellence in Technology Award aims to recognise and reward innovative technology or the use of technology implemented by a pharmacy, which have made a significant contribution to the overall business.

This Award recognises will be looking for examples of outstanding innovation and application of technology in community pharmacy, enhancing patient care, operational efficiency, and overall pharmacy services. Entries should demonstrate how technology has been effectively implemented to improve outcomes for patients, pharmacy teams, or the wider healthcare system.

This category will be looking to recognise achievement in the development and/or Implementation of new/updated technologies during the past 12 months.

Judges will be expecting to see evidence of results; entries must be made demonstrating how they used the nominated technology over the last year.

How to Enter:

Open to independent and chain community pharmacies, pharmacy professionals or teams who have successfully integrated technology into their practice. The technology solution must have been implemented within the past 2 years and show measurable impact.

Entries must provide evidence of innovation, effectiveness, and sustainability in the use of technology within the community pharmacy sector.

Awards Criteria:

1. Innovative Use of Technology: How the pharmacy has adopted or developed technology to improve patient care, safety, or operational efficiency.

2. Measurable Impact: Clear evidence of positive outcomes, such as improved patient adherence, enhanced workflow efficiency, or reduced medication errors.

3. Integration & Collaboration: How well the technology integrates with existing pharmacy systems and supports collaboration with healthcare providers or patients.

4. Scalability & Sustainability: The long-term viability of the technology, its potential for wider adoption, and how it continues to drive improvements in community pharmacy services.

Applications Close - Friday, April 11th, 2025 Send your entries to - kelly-jo@ipn.ie

Download application forms from: https://irishpharmacyawards.ie/

Perrigo Superintendent Pharmacist of the Year 2025

Superintendent pharmacists have overall responsibility for setting out the standards and policies for the provision of pharmacy services by their organisations. The role of Superintendent Pharmacist is a key position carrying full time responsibility and accountability.

This Award will be looking to recognise those individuals who are serving as key drivers for the implementation of enhanced and excellent pharmacy care within the community they serve. Judges will be looking for applications from those that are focused on establishing a framework for achievement of a high quality, safe and consistent service for the benefits of the patient, as well as facilitating the development of the professional role of the pharmacist.

How to Enter:

Judges will be looking for applications from those that are focused on establishing a framework for achievement of a high quality, safe and consistent service for the benefits of the patient, as well as facilitating the development of the professional role of the pharmacist.

Awards Criteria:

Applications are invited from independent and multiple Superintendent Pharmacists who can demonstrate one or more of the following:

1. Understanding patient needs when delivering healthcare in the community.

2. Examples of great patient experience and care, innovation and ambition.

3. Best practice in delivering professional services and patient reviews.

4. Encouragement of staff education in patient health and wellbeing advice.

5. Strong leadership skills with the ability to drive the business forward.

PKF Brenson Lawlor Young Community

Pharmacist of the Year

2025

The PKF Brenson Lawlor Young Community Pharmacist of the Year Award recognises rising talent – those individuals who despite being in the early stages of their pharmacy careers are already demonstrating that they can make a difference to the pharmacy profession and the companies for whom they work and the communities they serve.

How to Enter:

This Award is open to pharmacists aged up to 30 - at the date of entry submission - who are working within any pharmacy, multiple or independent, where their involvement has been greater than six months. It is the individual qualities that will be evaluated, rather than those of any of the projects worked on.

Awards Criteria:

1. Judges will want to see effective communication skills with both staff and customers.

2. Demonstration of a commitment to mentoring or other leadership activities.

3. Operation within their own pharmacy liaising with key staff members and management and developing key communication skills.

4. A dedication and commitment to furthering the profession into the future.

Applications Close - Friday, April 11th, 2025 Send your entries to - kelly-jo@ipn.ie

Download application forms from: https://irishpharmacyawards.ie/

Reckitt Community Pharmacist of the Year 2025

The Reckitt Community Pharmacist of the Year Award seeks to recognise a community pharmacist who is defining the future standard of pharmacy practice by his or her professional practice and/or by advocacy in the pharmacy industry.

Judges will be looking for those who demonstrate leadership and exemplifies the evolution of the pharmacy profession towards an expanded role in health care. The winner will be able to show significant contributions to the pharmacy industry overall resulting in meaningful improvements in the quality of patient care and improved delivery models and pharmacy’s role on the health care team. Applications are invited from both the independent and chain sectors.

How to Enter:

To be eligible, a nominee must have been practicing for at most 5 years. Those working under the age of 30 should apply for the Young Community Pharmacist of the Year category.

Awards Criteria:

1. Evidence of long-term, consistent dedication and outstanding achievements that have led to the advancement of the profession of pharmacy and public health.

2. Evidence of a large variety of skills, attributes and accomplishments.

3. Evidence of an individual strong in character, cumulative professional accomplishments and the ability to properly represent and model what pharmacy as a profession encompasses.

4. Evidence of an understanding the goals of pharmacy, and significantly contributing to how these goals may be achieved.

This Award will be given to the community pharmacy team that demonstrates the best combination of team spirit and enhancement of patient care at all levels.

The judges will be looking for those who encourage and support each other and those who have collectively demonstrated innovation and forward thinking.

How to Enter:

The key to any successful pharmacy is teamwork and this Award recognises the power and potential of a focused and unified approach to healthcare initiatives. Teams can be based within one organisation or spread over multiple organisations; but they must comprise individuals working towards the same objective or goal.

Awards Criteria:

1. How the team has demonstrated their ability to deliver clear benefits to patients; and/or staff members through working together efficiently and effectively.

2. How the team has worked together to achieve its objectives over the past twelve months.

3. Projects that the team has successfully managed which demonstrate excellence in quality, innovation, productivity and prevention.

4. A clear display of the principles underpinning their success as a team.

Applications Close - Friday, April 11th, 2025 Send your entries to - kelly-jo@ipn.ie

Download application forms from: https://irishpharmacyawards.ie/

Alliance Community Pharmacy Technician of the Year 2025

It is evident that Pharmacy Technicians are playing an increasingly important supporting role as pharmacists are increasingly spending more time with patient consultations and engaging local stakeholders.

The shift in emphasis from dispensing to healthcare provision has meant that the wider pharmacy team has to pull together – Pharmacy Technicians capture the essence of this in everything that they do.

This Award will recognise the winner’s important contribution to the community Pharmacy Technician profession. Applications are invited from both the independent and chain sectors.

The winners’ achievements will be an inspiration to those pursuing innovative practice; to those striving to raise standards; and to pharmacists who, through their professionalism, provide models for others within pharmacy.

How to Enter:

The judges will be looking for those who can demonstrate promotion of the role of the Pharmacy Technician and those who continue to champion excellence through forward thinking and innovation.

Awards Criteria:

1. Evidence of long-term, consistent dedication and outstanding achievements that have led to the advancement of the profession of pharmacy and public health.

2. Evidence of a large variety of skills, attributes and accomplishments.

3. Evidence of an individual strong in character, cumulative professional accomplishments and the ability to properly represent and model what pharmacy technicians as a profession encompasses.

4. Evidence of an understanding the goals of pharmacy, and significantly contributing to how these goals may be achieved.

Finance

Auto Enrolment – The End of False Dawns?

Since we first started advising members of the pharmacy community 20 years ago auto enrolment (AE) has hovered in the background and now it would appear from recent government comments that Q4 2025 is a date they will not miss.

This is a system a long time in planning since Seamus Brennan’s first white paper back in 2007 through to 2024 when the Auto Enrolment bill was adopted into legislation. Employers need to be aware of the upcoming costs and associated administration of employee contracts, policies and procedures which are significant.

Timing

There is a strong argument the timing is poor for employers, with rising cost pressures on small businesses, from the new sick pay scheme and minimum wage requirements and equally for employees who are struggling with cost of living pressures we are all familiar with.

There is no doubt AE is needed as only 1 in 3 in the private sector have pensions and face a substantial drop in income in retirement. PRSA’s were launched in 2002 to increase pension coverage, however this was voluntary and take up through workplaces was low. PRSA’s in their initial design were poor contracts and you would hope the government learned a lesson from that.

Of the 800,000 workers that do not have a pension, 200,000 are higher rate tax payers and for them AE is a very poor outcome, more on this later. Ireland has an ageing population and currently

Written by Colm Moore

CERTIFIED FINANCIAL PLANNER™

with Moore Wealth Management. In 2025 they will have been advising the pharmacy community for twenty years. He can be contacted on 086-860 3953. For more see www.mwm.ie

determination of best pot wins, this means should an employee be in AE or your existing arrangement and what will deliver the best outcome for the employee. How that is determined is unknown at this stage.

for employers who prevent their employees from joining or who force them to opt-out or suspend contributions.

employee be in AE or your existing arrangement and what will deliver the best outcome How that is determined is unknown at this stage

How will this work?

This flow chart is from the National Auto Enrolment Savings Authority (NAERSA) and promises a seamless process for employers.

• Any withheld or underpaid contributions will attract interest payments.

It’s important if you are an employer that you make yourselves aware of your obligations and responsibilities towards your employees.

This ﬂow chart is from the National Auto Enrolment Savings Authority (NAERSA) and seamless process for employers

we have 3.5 workers paying for every 1 retiree. In 20 years, this ratio will reduce to 2:1 which is not sustainable. Creating wealth in retirement will reduce pressures on state systems such as the health service and social welfare.

Who will be enrolled in the scheme?

‘Eligible’ employees will be anyone between the ages of 23 and 60 earning ¤20,000 or more. Those outside these ages will be allowed to opt in. This will be a semimandatory scheme designed to allow the employee to opt out with a window after 6 months in months 7 and 8. During this window the employee will be entitled to a refund of their contributions, the employer contributions and the state top up remain invested. To prevent inertia in all instances employees will be re-enrolled every 2 years and it’s important to note the v20,000 can come from multiple employments.

Exemptions

Any contribution to a pension of any amount from an employer or an employee through payroll will exempt the employee from autoenrolment, the amount does not matter initially.

If you currently have a scheme, it’s likely to be voluntary and now you have a situation where anyone not in that pension scheme through payroll, will be auto enrolled on meeting the criteria, which could mean you are managing two schemes.

Eligible employees identified through Revenue data with no waiting period for employees

Payroll notification will be sent via payroll software and employer applies payroll notification

Contributions based on gross pay collected from employer and employee

Contributions are invested on behalf of employees

Pots will follow employees across jobs through their working life

Cost?

To administer the auto - enrolment system, a new body called the Central Processing up. It will be within the Department of Social Protection at ﬁrst, before becoming an You won’t have the responsibility around who should or shouldn’t be in the scheme, take care of this.

Normally someone on a probationary period does not go into a pension but if they meet the AE criteria of an eligible employee above they will be auto enrolled from their first pay packet. The intention is that standards will be brought in c. 2032 with the

To administer the auto-enrolment system, a new body called the Central Processing Authority will be set up. It will be within the Department of Social Protection at first, before becoming an independent body. You won’t have the responsibility around who should or shouldn’t be in the scheme, as the Authority will take care of this.

• Auto enrolment will be set out in legislation and therefore will be an employment

• There will be several protections including ﬁnes and penalties for employers employees from joining or who force them to opt- out or suspend contributions.

• Auto enrolment will be set out in legislation and therefore will be an employment right.

• There will be several protections including fines and penalties

One of the key questions you’re likely to have is how much this will cost you. To help everyone adjust and get used to this extra cost, contributions will be phased in over a decade. Contribution rates start at 1.5% of gross overall earnings up to ¤80,000 from both the employer and employee. The system is supported by a state top up of ¤1 for every ¤3 that the employee contributes. The rates will increase every three years by 1.5% until year 10 when they reach 6% Employer, 6% Employee and 2% state top up.

• Any withheld or underpaid contributions will attract interest payments. It’s important if you are an employer that you make yourselves aware of your responsibilities towards your employees. Cost?

a 4.2% unemployment rate and you are well aware the hunt for talent is real and good staff are in demand. Work from home is not a benefit option employers can offer so employers in this sector are increasingly turning to pensions and income protection to attract and retain staff.

Why would anyone knowingly subscribe to an inferior system?

Salaries are your biggest cost and from Q4 2025 every €100,000 of salary you pay to employees not already in a pension scheme is an additional cost of €1,500 in Years 1-3, rising to €3,000, €4,500 and €6,000 in years 4, 7 and 10. You will be able to claim corporation tax relief on these payments.

Salaries are your biggest cost and from Q4 2025 every ¤100,000 of salary you pay to employees not already in a pension scheme is an additional cost of ¤1,500 in Years 1-3, rising to ¤3,000, ¤4,500 and ¤6,000 in years 4, 7 and 10. You will be able to claim corporation tax relief on these payments.

• On retirement AE offers 25% tax free plus a fully taxable lump sum as currently written with no option to leave the balance growing tax free. This means 75% of the fund could be hit with tax close to 50%.

To be clear, this phasing in will take place in the ﬁrst decade of auto -enrolment, not in the ﬁrst ten years of an employee’s career. All new employees joining after year ten will start at the 6% rate.

Initially, employees will see 1.5% of their gross pay taken from their net pay rising over time.

Contracts and HR

Anyone paying tax at 40% entering AE is making a mistake. Under a standard pension they would pay ¤60 to get ¤100 into their fund. Under AE this cost increases to ¤75 and they have an inferior and inflexible scheme.

• There is no option to increase funding if an employee wants to

To be clear, this phasing in will take place in the first decade of auto-enrolment, not in the first ten years of an employee’s career. All new employees joining after year ten will start at the 6% rate.

• Contracts of Employment

Those paying tax at 20% are slightly better off but that is outweighed by AE and its failings which we will get into next. Employees paying 40% tax will be asking employers for a better scheme.

• There is no advice in the process which will lead to poor investment outcomes.

Employers need to ensure HR policies and procedures are up to date AE constitutes a change in an employees terms of employment. You will need to update

Initially, employees will see 1.5% of their gross pay taken from their net pay rising over time.

• Policies and Procedures

• Employee Handbooks

Advantages of Standard Pensions

This is a large body of work that most are unaware of.

Contracts and HR

Employers need to ensure HR policies and procedures are up to date. AE constitutes a change in an employees terms of employment. You will need to update

Vesting is a key feature of traditional pensions, this means the employer has the right to a refund of contributions up to 24 months if an employee leaves and is the only protection for employer contributions through traditional pensions. In AE they are the members from day 1 and no employer refund applies. Protect your business and contributions by utilising the superior pensions already available. This is an unavoidable cost coming down the line and you have time to get ahead of this by offering employees a better scheme that will produce better outcomes in every aspect.

Why would anyone knowingly subscribe to an inferior system?

• Contracts of Employment

• Policies and Procedures

• Only 25% Tax Relief with AE, this is half of the benefit that those at 40% tax relief avail of. In a standard pension with tax relief ¤60 turns into ¤100 and that’s an 66% immediate gain before the funds go to work in a tax-free bubble for up to 30 years. With AE this immediate bounce is 33% (¤75 to ¤100).

• A recent announcement of a yet to be revealed flat fee has surprised everyone and is unfair to those with smaller funds that come as a result of a lower salary. An employee on ¤20,000 will have this fee on total contributions without growth in year 1 of ¤700 and an employee on ¤80,000 has that same fee on ¤2,800. If for example the flat fee is ¤25, one AE member has a fee equal to 3.5% of their fund and the other is paying 0.8% and this does not include fund management charges. How this is deemed fair and equitable is unclear.

To request a detailed guide on Auto Enrolment scan the QR code below and this will be sent to you.

Anyone paying tax at 40% entering AE is making a mistake. Under a standard pension they would pay €60 to get €100 into their fund. Under AE this cost increases to €75 and they have an inferior and inﬂexible scheme

Those paying tax at 20% are slightly better off but that is outweighed by AE and its failings which we will get into next Employees paying 40% tax will be asking employers for a better scheme.

• Employee Handbooks

This is a large body of work that most are unaware of.

Advantages of Standard Pensions

• Retirement with AE is linked to State Pension age (66) while standard pensions have flexible options from age 50

Opportunity

The country is close to what is guided as full employment with

• Only 25% Tax Relief with AE, this is half of the beneﬁt that those at 40% tax relief avail of. In a standard pension with tax relief €60 turns into €100 and that’s an 66% immediate gain before the funds go to work in a tax-free bubble for up to 30 years. With AE this immediate bounce is 33% (€75 to €100).

• Retirement with AE is linked to State Pension age (66) while standard pensions have ﬂexible options from age 50

Vitamin D Deficiency and Impact on Bone Health

Written by Dr Kevin McCarroll (Consultant Physician & Geriatrician, Bone Health Unit, St James’s Hospital, Dublin and Dr Donal Fitzpatrick (Consultant Physician & Geriatrician, Mater Misericordiae University Hospital, Dublin)

Vitamin D has a crucial role in maintaining normal bone and muscle health, though a significant proportion of the population are deficient. Indeed, in Ireland, 13.1% of the population older than 50 are vitamin D deficient (<30 nmol/l) based on findings from The Irish Longitudinal Study of Ageing (TILDA). In the winter, deficiency affected nearly one in four (24%) with the greatest prevalence (37%) in those aged over 80. Furthermore, about 15% of children and younger Irish adults have been found to be deficient.

Vitamin D is not a nutrient in the traditional sense, but a prohormone that is largely derived from cutaneous synthesis after UVB exposure. However, little or no vitamin D synthesis occurs in Ireland between the months of November and March giving rise to the so-called “vitamin D winter”. Dietary sources are limited and contributing only a small proportion to overall levels, but include fortified foods (milks, breakfast cereals), oily fish and eggs. For this reason, low vitamin D status is particularly common in those with limited sun exposure. A significant prevalence of vitamin D deficiency is observed in individuals with darker skin, who require prolonged sun exposure for adequate synthesis due to the presence of melanin. Notably, a study conducted in Ireland found that 67% of Southeast Asians were deficient in vitamin D.

Vitamin D is required for the adequate absorption of calcium and phosphate from the gut. In deficiency, as little as 10% of calcium is absorbed rising to 40%

in those who are vitamin D replete. This can result in secondary hyperparathyroidism (SHPT), which is associated with bone loss at cortical sites such as the hip, distal radius and humerus. SHPT also blunts the bone density increases in patients with osteoporosis who are on bisphosphonate or denosumab therapy.

A 25-hydroxyvitamin D level of less than 30 nmol/l is generally considered to represent deficiency, can result in SHPT and when severe causes rickets in children and osteomalacia in adults. There is a risk of vitamin D inadequacy when levels are between 30 and 50 nmol/l, which may be deleterious to bone health, though other factors like calcium and phosphate intake interact with vitamin D and play a role. Indeed, higher calcium intake can partially compensate for lower vitamin D status in reducing SHPT. A recent large study of older Irish adults (n=4139) identified that one third with vitamin D deficiency had SHPT, as did nearly 15% with 25(OH)D levels between 30 and 50 nmol/l. This SHPT was associated with lower bone density at the hip consistent with other studies. Based on the same study, it was estimated that 8.5% of Irish adults (aged ≥50 years) may have SHPT in the Winter. In frailer and older adults, this prevalence is likely to be significantly higher. In one study (n=165), nearly one third (30.1%) of Irish patients admitted to hospital with a hip fracture had high parathyroid (PTH) levels due to low vitamin D status.

For patients with low bone density or a diagnosis of osteoporosis, serum 25(OH)D level should be at

least ≥50 nmol/l. In about 5-10% with SHPT and 25(OH)D levels between 50 and 75 nmol/l aiming for a level ≥75 nmol/l is also advised. Indeed, a target level of ≥75 nmol/l is recommended for older adults by some bodies including the American Geriatric Society, particularly for those who are frail and at risk of falls and fractures. Maintaining a 25(OH)D level ≥50 nmol/l is also essential for patients with osteoporosis who are on potent anti-resorptive treatments (e.g. denosumab or zoledronic acid) in order to prevent hypocalcaemia.

In most cases, oral supplementation with 800 to 1,000 IU of cholecalciferol (vitamin D3) daily is sufficient to maintain levels ≥50 nmol/l. However, higher doses may be required if there is poor gut absorption, obesity or liver disease. A variety of vitamin D3 tablets are licensed to treat or prevent deficiency and include daily (800 IU or 1,000 IU), onceweekly (7,000 IU) or once-monthly (25,000 IU). Therapy with 50,000 IU of vitamin D3 once weekly for about 6-8 weeks can be used for more rapid correction of deficiency. More recently, there is the option of supplementing with calcifediol (25 hydroxyvitamin D) which has better gut absorption and results in a faster rise in serum 25(OH)D. This is available as a once monthly (255 mcg) tablet and should be especially considered in those with malabsorption syndromes or significant liver disease.

While the above recommendation applies to adults with low bone density, widespread supplementation of the population is not supported by vitamin D “mega-trials”. However, these included few patients with vitamin D deficiency in whom they were underpowered to examine for differences in fracture rates. However, given the high prevalence of deficiency in the Irish population, a targeted approach has been adopted by the Food Safety Authority of Ireland (FSAI). For fair skinned individuals (aged 12 to 65), daily supplemental vitamin D of 600 IU is recommended during the winter months (end of October to March). For older adults (≥65 years) and individuals with darker skin, supplementation (600 IU daily) is recommended all year round.

It is also important to maintain adequate calcium intake for optimal bone health. In those with low bone density, a calcium intake of up to 1000 mg daily is generally advised (include dietary and supplements). European guidelines also recommend 950 mg daily for adults (≥25 years). Most dietary calcium is derived from dairy products (a portion typically contains 200-250 mg), with three portions recommended per day. However, dairy intake in Irish adults is low at just under two portions daily. Furthermore, the vast majority (97%) of older Irish adults (aged ≥60) in a large study (n=4444) were found to consume less than three dairy portions daily. For those aged ≥65 who consume less than one dairy portion per day, a 500 mg calcium supplement daily is recommended by the FSAI.

Combined vitamin D and calcium supplements may have a modest affect in reducing the incidence of hip or any fractures. However, meta-analyses that examined for fracture outcomes also included patients who had adequate calcium intake and vitamin D status. In particular, the benefit of combined supplements appears greatest in those with poorest vitamin D status and lowest dietary calcium intake. In one large study (n=3270) of ambulatory older adults in nursing homes, supplementing with vitamin D and calcium reversed SHPT and fractures rates at the hip by 43% and at non-vertebral sites by 32%. However, not all patients need supplemental calcium, and an individualised approach should be taken. For those with inadequate dietary calcium, supplements can be used to achieve target intake of about 1000 mg daily.

In conclusion, there is a high prevalence of vitamin D deficiency in Ireland which contributes to secondary hyperparathyroidism, bone loss, and fracture risk, especially among older adults and those with limited sun exposure. Achieving a serum 25(OH)D level of at least 50 nmol/L (and ensuring adequate dietary calcium) can mitigate these risks. Addressing vitamin D deficiency is a significant priority at both the public health and individual health levels, requiring targeted interventions to improve awareness and supplementation.

Dr Kevin McCarroll

Dr Donal Fitzpatrick

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Topic Team Training – Acne

A community pharmacy environment that fosters teamwork ensures high levels of consumer satisfaction. This series of articles is designed for you to use as a guide to assist your team in focusing on meeting ongoing CPD targets and to identify any training needs in order to keep the knowledge and skills of you and your team up to date.

The below information, considerations and checklist provide support to enable you to run a team training session and identify opportunities for learning within the topic of Acne.

Acne is a very common inflammatory skin condition affecting > 80% of teenagers and up to 20-40% of adults. Recent studies show a rate of 9.4% of the global population is affected.

Most commonly it affects the face, however it may also occur on the back, chest, upper arms, neck and scalp. The cause is multifactorial with a complex interplay between genetics, hormonal influences, especially for females, and also environmental factors.

At puberty, hormone levels suddenly increase resulting in our oil glands becoming oversensitive to these hormones causing an increase in oil/sebum production.

Consider:

 The causes of acne

This sticky oil/sebum combines with our dead skin cells which are ineffectively shed from the skin’s surface, resulting in blockage of our pores and the formation of a blackhead (comedone).

Adult-onset acne is becoming increasingly common affecting up to 20% of men and 20-40% of women. This may occur in those who previously suffered as a teenager or it may occur for the first time as an adult. In women, hormonal acne is more commonly noted on the lower face, jawline, chin and neck and often flares pre-menstrually.

Treatment of acne depends on severity, however the first port of call is often to one’s pharmacy. It is therefore important to distinguish between mild, non-scarring acne and those who are scarring.

If one has mild acne suitable therapies include over the counter

 Awareness of some of the most common myths about acne

 The benefits of appropriate lifestyle and good skin hygiene factors

 Awareness of the OTC acne treatments for customers

topical treatments containing salicylic, glycolic and lactic acid which may come in the form of a wash or leave on product. This combination of AHA’s and BHA’s help to keep the skin smooth, unblock the pores and reduce oil production. OTC benzoyl peroxide may also be effective for it’s antibacterial effect on the skin, without the risk of resistance. This may be used on a nightly basis, however I would advise slow introduction to prevent over-drying of the skin and also use of a suitable moisturiser for hydration. (non-

Key Points:

Check your pharmacy team are aware and understand the following key points:

 The pharmacy team is aware of the signs and symptoms of acne

 The team are knowledgeable on the OTC treatments available

 The team know how to spot a red flag and refer a customer

 My pharmacy assistants can meet the points in this training checklist.

comedogenic, non-blackhead forming moisturiser)

If during a consultation with a customer one can see any sign of early scarring then the person should be directed to their GP to commence systemic therapies as early as possible to prevent further scarring.

Combination therapies are important for the treatment of acne as they have a synergistic effect, therefore you may see patients being prescribed oral therapies such as tetracycline antibiotics or hormonal therapies such as the COCP or Spironolactone as well as prescription retinoids, as studies show that patients commenced on retinoids combined with the above oral therapies have a better outcome.

It is also important to recommend products which provide adequate skin hydration to those patients who are taking oral isotretinoin for the management of scarring acne or acne which has failed other therapies. These patients may need preservative free eyedrops, nasal sprays, sunscreen and emollients for both face, body and especially the lips.

Actions:

 Ensure the team can assess the severity of acne, determining whether it is mild, moderate or severe

 Ensure that I and the team can advise on appropriate skincare such as educating customers on maintaining a gentle routine

 Do we understand the expectations of customer and side effects they may encounter from acne treatments? Such as the time taken to yield results

 Are we able to provide confidential and discreet consultation rooms?

 Can we provide good advice on the different types of OTC treatments and their suitability for each patient

 Train the team to meet all the above considerations

Type 2 Diabetes

The Evolution of Weight Loss Drugs: Implications for Type 2 Diabetes

Written by Morgan Reid and Dr Christopher Shannon - Diabetes Complications Research Centre, UCD

Type 2 diabetes (T2D) is a progressive metabolic disorder characterized by insulin resistance, beta-cell dysfunction, and chronic hyperglycaemia with significant risk of renal and / or cardiovascular complications. Given the close relationship between T2D and obesity, weight reduction has long been recognized as a key goal for patients with T2D. Although weight loss of 10-15% is associated with improved insulin sensitivity and glycaemic control, traditional approaches to weight management (i.e. diet and exercise) typically do not achieve durable weight reduction. Indeed, only 1 in 5 individuals with overweight or obesity are successful in sustaining >10% weight loss long-term with lifestyle interventions alone. Importantly, weight regain is paralleled by declines in glycaemic control and T2D progression.

In the past two decades, the development of the glucagonlike peptide-1 (GLP-1) receptor agonists has reshaped the therapeutic landscape of chronic weight management and cardiometabolic diseases, including T2D. These drugs elicit greater weight loss than is achieved by lifestyle intervention alone and lead to wide-ranging cardiometabolic benefits. In this article, we discuss what the rapid evolution of these drugs means for patients with T2D.

Clinical development and efficacy of GLP-1 receptor agonists

GLP-1 receptor agonists (GLP-1 RA) mimic endogenous GLP-1, an incretin hormone that enhances glucose-dependent insulin secretion, suppresses glucagon release, slows gastric emptying, and promotes satiety via central appetite regulation. Although now widely recognised for their efficacy as weight loss drugs, the first GLP-1RA (Exenatide from Eli Lilly) was initially approved in 2005 as a twice daily injectable for T2D. It wasn’t for another ten years that

the daily injectable Liraglutide (Novo Nordisk) was approved for the treatment of obesity. The continued development of this drug class has led to the approval of numerous once-weekly injectable, and one daily oral, GLP-1RAs for patients with T2D. Further innovation in GLP-1 based therapies led to the approval of Tirzepatide (Eli Lilly), a dual glucose-dependent insulinotropic (GIP)/GLP-1 receptor co-agonist, for both T2D and obesity.

Data from multiple large phase three clinical trial series have demonstrated that GLP-1RA reduce HbA1c by 0.9-1.8% in patients with T2D, depending on the agent and dose used. Interestingly, body weight reduction with GLP-1RA treatment is typically lower in patients with obesity and T2D (5-10% weight loss), versus individuals without T2D (~15% weight loss). Notably, dual targeting of GLP-1R and GIPR receptors with Tirzepatide appears even more effective for glycaemic control and weight reduction versus single peptide treatments. Beyond glycaemic control and weight loss, GLP-1RAs have also been shown to reduce the risk of cardiovascular death, stroke, myocardial infarction, and kidney disease in patients with T2D and/or obesity. Clinical trials investigating the efficacy of GLP-1RA against metabolic-dysfunction associated steatohepatitis (MASH), peripheral arterial disease, Alzheimer’s and Parkinsons are also ongoing.

Drawbacks of incretin-based therapies

Despite their significant benefits, incretin-based therapies are not without limitations. The most common adverse events include gastrointestinal issues such as nausea and vomiting, which can negatively impact adherence. A related concern is the requirement for sustained therapy, since, as with most weight loss modalities, treatment withdrawal leads to weight regain and rebound risk of disease progression. Moreover,

25-40% of the weight lost with GLP-1RA treatments is lean mass rather than fat mass. Whilst the functional implications of this are currently unclear, reductions in lean mass are closely associated with decreased energy expenditure and thus likely contribute to the drive for weight regain if treatment is stopped. A major component of lean mass is skeletal muscle, which is especially important for glucose metabolism, mobility and overall metabolic health. The longterm consequences of lean tissue reduction with GLP-1RA therapy in patients with T2D therefore require further investigation, particularly in populations vulnerable to sarcopenia, such as older adults or individuals with pre-existing muscle loss.

Finally, the availability and affordability of newer drugs remain significant barriers, with many healthcare systems and insurance providers offering limited coverage for obesity pharmacotherapy. This raises questions about the feasibility and equitability of the lifelong treatment paradigm needed for continued metabolic benefits. Addressing these challenges will be critical in optimizing the widespread clinical adoption of incretin-based therapies.

Unanswered questions and future directions

Despite the success of incretinbased therapies, there are still important gaps in our understanding. One pressing question is whether preserving lean mass during GLP-1RA treatment could improve outcomes in T2D. Since skeletal muscle is essential for glucose uptake and overall metabolic health, strategies that protect muscle mass during weight loss may further enhance long-term benefits, particularly in high-risk populations (e.g. sarcopenia). Several musclepreserving compounds are currently under investigation with GLP-1RA as potential combination therapies, including agents

targeting the activin and apelin signalling pathways.

The introduction of Semaglutide and Tirzepatide has already prompted shifts in treatment paradigms, with the American Diabetes Association guidelines now prioritizing these agents for weight loss and glycaemic goals in patients with T2D. Looking ahead, several new therapies are in development, potentially pushing the boundaries of metabolic treatment even further. For example, Retatrutide (Eli Lilly) is a triple agonist that targets the GLP-1, GIP, and glucagon receptors, and has shown early promise for even greater weight loss and metabolic improvements than Tirzepatide. Meanwhile, Amgen’s investigational oncemonthly injectable drug MariTide has shown significant promise in Phase two trials, resulting in 17% weight loss and a 2.2% drop in HbA1c in patients in T2D. Paradoxically, this drug combines a GLP-1RA with a GIP antagonist, highlighting that our understanding of incretin biology is still evolving.

As newer therapies continue to emerge, and our understanding of patient responses expands, it may become possible to refine treatment strategies based on individual metabolic phenotypes or genotypes. Future research should focus on personalized medicine approaches, optimizing drug selection for different patient subgroups to maximize efficacy while minimizing side effects. As the field continues to evolve, the next generation of metabolic therapies may not only improve glycaemic control but also address broader aspects of body composition and long-term metabolic health. For healthcare professionals, staying informed about these developments is crucial for optimizing treatment decisions and ensuring that patients with T2D receive the most effective and individualized care possible.

Women’s Health – ‘Poorly Understood’

The School of Population Health at RCSI University of Medicine and Health Sciences has launched a Women’s Health Research Network to promote and advance research dedicated to women's health in Ireland.

An event to mark the launch – Advancing Women’s Health Research in Ireland: Bridging Gaps and Building Collaborative Pathways – took place at the RCSI campus on Stephens Green last month to coincide with International Women’s Day.

The event brought together researchers, healthcare professionals, policymakers and patient advocates to discuss research priorities and opportunities for collaboration.

Women experience unique health challenges, yet many conditions remain poorly understood or lack tailored prevention, diagnosis and management strategies:

• One-in-five women of reproductive age lives with obesity in Ireland impacting reproductive health, pregnancy outcomes and intergenerational health.

• One-in-six couples in Ireland experiences infertility.

• Endometriosis effects an estimated 155,000 of women in Ireland.

• Young women in Ireland have the highest levels of negative mental health.

• Heart disease and stroke account for a quarter of all female deaths in Ireland.

• Menopause increases the risk of osteoporosis and heart disease.

• Each year almost 3,600 women are diagnosed with breast cancer in Ireland – 30% of all cancer diagnoses.

Leaders of the new network are calling for significant increases in funding for women’s health research in Ireland.

Dr Angela Flynn, co-founder of the Women’s Health Research Network at RCSI highlights the challenges, "Women’s health has been underrepresented in Ireland’s research agenda for far

Dr Angela Flynn, co-founder of the

too long. A long-term investment strategy is needed to secure dedicated funding from national agencies. Additionally, increasing opportunities for early and midcareer researchers is critical to training and retaining the next generation of women’s health scientists in Ireland."

The event featured discussions, patient perspectives and conversations about the future of women’s health research in Ireland.

Fast-growing teen skincare brand announces launch in Boots Ireland

A fast-growing skincare brand focused on clearing sensitive young skin has just announced that it will be launching in Boots Ireland.

Bare Addiction was founded with a mission to create skincare that is both safe and effective, specifically designed to meet the needs of tweens, teens, and young adults. The brand emerged from founder Mark Poole's personal struggle with persistent breakouts during his teenage years. Frustrated by the lack of products that both cleared his skin and satisfied his mother's demand for natural, gentle ingredients, Mark set out to develop a solution. Bare Addiction was born out of this need for a skincare range that bridges the gap between teens' desire for fast results, and parents' concerns about safety and naturalness. By combining natural and scientific ingredients, Bare Addiction provides affordable, gentle, and effective skincare for young people dealing with problematic skin.

Since its inception in 2020, the skincare startup has seen rapid growth - and after having already found success in independent pharmacies, salons, and McCabes, Bare Addiction caught the attention of Boots, and is now set to launch in 30 shops in Ireland.

Ahead of the launch, Bare Addiction founder Mark Poole has said:

“We're excited to partner with Boots Ireland to bring our skincare range to more Irish tweens and teens. After successful launches in independent pharmacies, salons, and McCabes, this collaboration is a major step in ensuring young people have access to the right skincare. With the rise of social media trends, particularly on TikTok, many young people are led astray by products that

aren't suitable for their skin. Our range, developed with leading dermatologists and scientists, strikes the perfect balance of natural and synthetic ingredients to safely tackle problematic skin. Unlike fleeting trends, we focus on proven, reliable solutions. We've also introduced innovative

products like our SPF30 day cream with blue light protection, offering tweens and teens a smart alternative to 'legacy brands.'”

The full Bare Addiction range is set to launch on 31st March.

Mark is available for further comment and media interviews.

Women’s Health Research Network with Network Members

Immune Cell ‘Memories’ – Increasing Risk of Blood Clots

New research from RCSI University of Medicine and Health Sciences has found that white blood cells which ‘remember’ past inflammation events are quick to overreact, raising the risk of blood clots.

People living with inflammatory conditions, such as inflammatory bowel disease, blood cancers and sickle cell anaemia, can have a higher risk of blood clots.

The new study, published in the high-impact journal Science

Advances, explores how episodes of inflammation in such diseases can result in the production of white blood cells called myeloid cells that have increased blood-clotting activity, which persists long after the inflammation took place.

New Research on Shingles

Lead researcher on the study and Associate Professor at RCSI's School of Pharmacy and Biomolecular Sciences

Immune memories are important, according to researcher Dr Aisling Rehill, Senior Postdoctoral Fellow at the Irish Centre for Vascular Biology, RCSI. “Certain immune cells can ‘remember’ past encounters with inflammation or infection, a concept known as trained immunity. This memory allows them to respond more aggressively to future threats,” says Dr Rehill.

But this ‘shortened fuse’ could have consequences that are not

desirable and actual contribute to disease, she adds.

“Our study found that this heightened response can have unintended consequences. When these myeloid cells in the immune system have been trained by prior exposure to specific inflammatory agents, they also become more likely to promote blood clotting. Similarly, mice trained by exposure to specific inflammatory agents experience changes in their bone marrow that mean they produce new immune cells with a lower threshold to start blood clotting weeks after the original exposure.”

The research, which was carried out by experts at RCSI, FutureNeuro, Trinity College Dublin and Children’s Health Ireland, could help to explain why people living with inflammatory disease can have a relatively high risk of blood clots and the complications they bring, according to lead researcher on the study Professor Roger Preston.

The authors also suggest that the insights from the study could form the basis for targeted treatments to help prevent or manage conditions where the immune system and clotting system are overly active.

Half of Irish people aged between 50 – 60 say they don’t know much about shingles, according to new research conducted to coincide with Shingles Awareness Week 2025, which took place from 24th February – 2nd March.

Considering that over half (51%) of those surveyed also say that they feel younger than their age, a positive indicator of healthy ageing, this is a concern since 90% of adults carry the varicella zoster virus putting them at risk of shingles. As immune function declines with age this virus, which remains dormant in the nervous system, can reactivate causing shingles.

48% of respondents in the survey reported long-term health conditions such as diabetes, cardiovascular disease, chronic obstructive pulmonary disease (COPD) and chronic kidney disease. This may indicate that a large proportion of the population aged between 50 and 60 have a degree of immunocompromise which could place them at increased risk of shingles.

Despite that, just 9% say they are very concerned about contracting shingles, with 45% saying they are a little bit concerned, and 37% saying they are not at all concerned.

Only 24% of those surveyed are very aware of age-related diseases and take proactive steps to limit their impact, 55% are somewhat aware and try to stay healthy by taking some precautions, while 12% of respondents are not aware of any conditions that may affect them now or in the future.

In addition to age, pre-existing health conditions and ongoing medical treatment, stress and negative feelings such as loneliness and depression can further weaken the immune system, increasing the risk of developing shingles. 56% of respondents report that stress

is affecting daily life, while 16% ‘struggle to cope most days’ and 2% are at ‘crisis level’, which may potentially increase their risk.

Over one quarter (28%) of Irish people are also not aware that you can develop shingles more than once and over four in ten (42%) did not know that blindness is a rare complication of shingles. Additionally, over four in ten (41%) incorrectly believe that shingles is contagious, while a quarter of people surveyed (25%) did not understand the link between chickenpox and shingles. 21% are also unaware that shingles can cause long-term nerve pain.

One-in-three people who have had chickenpox are at risk of developing shingles in their lifetime. The disease, which typically presents as a rash, with painful blisters across the chest, abdomen or face, is

often described as aching, burning, stabbing or shock-like. Following the shingles rash, a person can also experience post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and occasionally persist for several years. PHN occurs in around 20% of all shingles cases, with the over50s particularly at risk. 10-15% of shingles cases can affect the eye which in some cases can result in serious eye complications.

GSK Ireland is also running a shingles disease awareness campaign across radio and social media in March and early April, encouraging people to speak to a healthcare professional or visit understandingshingles.ie to learn more about shingles.

www.understandingshingles.ie

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 symptoms occur whilst

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. Further information is available on

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. Coadministration 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.

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

The Forgotten Garden: The Role of Plant-Based Foods in Health and the Microbiome

Written by Dr Lucia Braz, Registered Dietitian, BeyondBMI and Dr Werd Al-Najim, Registered Dietitian, University College Dublin, Prohealth365 Physiotherapy & Nutrition, and BeyondBMI

In recent decades, Western dietary habits have undergone a seismic shift. Traditional, nutrient-rich plant-based foods have been steadily replaced by ultraprocessed, convenience-driven options. This shift extends far beyond calorie counts, profoundly influencing microbiome health and fuelling the rise of chronic diseases.

For healthcare professionals, understanding the pivotal role of plant-based foods and advocating for their inclusion is not just a dietary recommendation; it is a public health imperative.

The Benefits of Plant-Based Foods

Plant-based foods, including fruits, vegetables, legumes, whole grains, nuts, and seeds, are nutritional powerhouses. Packed with vitamins, minerals, fibre, and phytochemicals, they form the cornerstone of a balanced and healthy diet, promoting longevity and reducing the risk of chronic diseases. These foods confer a multitude of health benefits:

• Nutrient Dense: Plantbased foods provide a broad spectrum of macronutrients, micronutrients, and antioxidants that are not readily available from other food groups. They supply essential vitamins, minerals, fibre, and bioactive compounds that support

cellular function, metabolic health, and disease prevention. Key phytochemicals—such as polyphenols, flavonoids, and carotenoids—play a crucial role in reducing oxidative stress and inflammation, further enhancing overall well-being.

• High Fibre Content: Dietary fibre, unique to plant foods, promotes gut motility, regulates blood sugar levels, and supports weight management.

• Cardiovascular Health: Diets rich in fruits, vegetables, and whole grains are linked to lower cholesterol levels, reduced blood pressure, and decreased risk of heart disease.

• Anti-inflammatory Properties: Phytochemicals, such as flavonoids and carotenoids, have anti-inflammatory effects that protect against chronic diseases.

The Western Diet and Its Downfall

Despite the well-documented benefits of plant-based foods, their consumption is declining in the Western world. Data from national dietary surveys reveal that many individuals fail to meet the recommended five to seven servings of fruits and vegetables per day. Instead, the modern diet is increasingly dominated by ultra-processed foods—items high in refined sugars, unhealthy fats, and additives, yet devoid of

essential nutrients and fibre. Their convenience and hyper-palatable nature drive consumption, but the long-term health consequences are severe. The Western diet’s low intake of whole, plantbased foods and its emphasis on processed options are contributing to a host of chronic diseases, including obesity, diabetes, and cardiovascular conditions. However, the less obvious—yet equally critical— impact lies in the disruption of gut microbiome health.

The Microbiome: A Forgotten Ally

The human gut microbiome, a vast ecosystem of trillions of microorganisms, plays a fundamental role in digestion, immune function, and even mood regulation. This microbial community is directly shaped by diet, influencing overall health and disease risk.

Plant-based foods are vital for a healthy microbiome because they:

• Provide Prebiotics: Fibres and resistant starches found in fruits, vegetables, and legumes serve as prebiotics, feeding beneficial gut bacteria.

• Promote Microbial Diversity: Diets rich in plant-based foods foster a diverse microbiome, which is associated with resilience against infections and chronic diseases.

• Supports Short-Chain Fatty Acids (SCFAs) production: When gut bacteria ferment dietary fibre, they produce SCFAs like butyrate, acetate, and propionate. These compounds have antiinflammatory effects, strengthen the gut lining, and regulate immune responses.

Chronic Diseases and the Microbiome Pathway

The decline in plant-based food consumption has far-reaching effects on the microbiome, creating pathways to chronic disease:

• Inflammation: A low-fibre diet starves beneficial gut bacteria, leading to the proliferation of pro-inflammatory microbes.

Chronic, low-grade inflammation is a hallmark of conditions like type 2 diabetes and cardiovascular disease.

• Gut Dysbiosis: The imbalance of gut bacteria caused by a processed diet can impair the gut lining’s integrity, leading to increased intestinal permeability or “leaky gut” syndrome. This allows toxins and pathogens to enter the bloodstream, triggering systemic inflammation.

• Metabolic Dysregulation: Dysbiosis can alter how the body processes energy, contributing to insulin resistance and obesity.

Practical ways to cultivate a healthy microbiome through diet include:

Increase Fiber Intake – Aim for at least 30g of fibre daily by incorporating whole grains (e.g., quinoa, oats), legumes (e.g., lentils, chickpeas), and a variety of colourful vegetables, see table 1.

Eat Fermented Foods Daily –Include probiotic-rich foods like yogurt, kefir, sauerkraut, kimchi, or miso to introduce beneficial bacteria and enhance microbial diversity.

Diversify Plant-Based Foods

– Rotate different types of fruits, vegetables, nuts, and seeds to encourage a rich and resilient microbiome. Studies show that eating at least 30 different plantbased foods per week leads to greater microbial diversity.

Reduce Ultra-Processed Foods and Artificial Sweeteners – Swap packaged snacks and sugary drinks for whole-food alternatives like homemade hummus with veggie sticks or unsweetened herbal teas.

Ingest Healthy Fats – Incorporate omega-3-rich foods like salmon, walnuts, and flaxseeds, which help reduce inflammation and support gut health.

Limit Red and Processed Meat – Opt for plant-based proteins like tofu, tempeh, or beans, which support beneficial gut bacteria without promoting inflammation.

Consume Polyphenol-Rich Foods – Add antioxidant-packed

Dr Werd Al-Najim

Dr Lucia Braz

Fibre Content of Common Foods

foods like dark chocolate (85%+ cacao), green tea, berries, and extra virgin olive oil to nourish gut microbes.

By making small, sustainable dietary changes, you can actively support a healthier gut microbiome, improving digestion, enhancing immunity, reducing inflammation, and even better mood regulation through the gutbrain axis. Instead of viewing diet as just a source of calories, think of it as a daily tool to cultivate a thriving microbiome that supports long-term health.

Fibre Content of Common Foods

World Kidney Day 2025

As part of World Kidney Day 2025 which was celebrated on Thursday 13th March this year, the Irish Kidney Association (IKA) is launching its national campaign ‘1 in 10 People’ to highlight the often-silent threat of kidney disease and the need to take action now to reduce the risk of kidney failure and its serious consequences.

The campaign also draws attention to the fact that high-risk groups can now be easily identified in primary care and a simple blood and urine test can reveal the presence of CKD. This offers a real opportunity for early treatment which can slow down the disease or prevent its progression.

The HSE National Renal Office supports the IKA’s campaign which will shine a light on the importance of early detection and management of Chronic Kidney Disease from a quality-of-life perspective as well as reducing the treatment cost of kidney failure.

In new research published at the University of Limerick School of Medicine, ‘Prevalence and Determinants of Chronic Kidney Disease among Communitydwelling Adults, 50 Years and Older in Ireland’ Professor Austin Stack, lead author and Consultant Nephrologist at University Hospital Limerick concluded that ”Compared to the national average, the burden of CKD is far greater in older individuals with major chronic conditions and socioeconomic deprivation. The identification and targeting of these groups through national surveillance programmes is likely to yield substantial benefits

from more effective disease management and proactive population health planning.”

The Irish Kidney Association’s campaign aligns with the World Kidney Day theme, ‘Are Your Kidneys OK? Detect early, protect kidney health’ , which calls for urgent action and attention to kidney health, especially as the disease affects an estimated 850 million people worldwide.

Unfortunately, CKD, often referred to as ‘the silent illness’, can go undetected until it reaches advanced stages, when treatment options become more limited and costly. There are

five stages of kidney disease – Stages 1 to 5. Once patients reach Stage 5, also known as End Stage Kidney Disease, their only treatment options to stay alive are dialysis treatment or kidney transplantation.

The financial burden of kidney disease in Ireland is substantial, with the cost of in-centre dialysis (hospital based and HSE contracted satellite dialysis units) alone reaching ¤228 million annually. Early detection and intervention, however, can help reduce these costs and prevent the need for life-altering treatments like dialysis or a kidney transplant.

Menopause: Beyond Hormonal Therapy

Want to find out more about EstroG-100? Clinically researched, natural extract for menopause symptom relief?

Join the online webinar, Menopause: Beyond Hormonal Therapy on Thursday 20th March, 7pm, sponsored by Menoelle Plus.

With over 100 clinically documented menopausal symptoms, this webinar equips you with proven, harm-free natural tools like EstroG-100, to enhance patient care.

With over 100 clinically documented menopausal symptoms, this webinar equips you with scientifically backed, safe natural tools like EstroG-100 to enhance patient care.

Discover how to revolutionise your menopause toolkit with a clinically proven, multi-symptom natural solution that empowers your patients while delivering results you can trust - because when science meets nature, everyone wins.

Discover how to revolutionise your menopause toolkit with a clinically studied, multi-symptom natural solution that empowers your patients while delivering results.

Presented by Bryce Wylde, BSc (Hons), DHMHS, a leading health expert with 25 years of clinical experience. Based in Toronto, Canada, he practices at

Venn Med, specialising in functional medicine, clinical nutrition, and supplementation.

As the co-founder of The DNA Company, he focuses on personalised genomics to optimise health. He has authored four bestselling books, produced micro-documentaries exploring natural Health innovations, and frequently appears as a guest health expert on national TV, podcasts, and social media.

Topics covered include:

• Introducing The All-Natural, Hormone-Free EstroG-100®

• Overview & Summery: GoldStandard Clinical Research on EstroG-100®

• Short Reception A Natural And Holistic Solution Clinicians Can Trust

• Facts & Figures: Brief General, Up-To-Date Overview on The Menopause Topic Register here: https://tinyurl. com/3pa5j2w5

New Therapeutic Solutions for Inflammatory Disorders

Professor Rosemary O’Connor, Professor of Cell Biology in the School of Biochemistry & Cell Biology, has received €1,275,723 for her project entitled 'Exploiting the spatial actions of metabolic and survival factors for therapeutic benefit.'

This research project addresses the Insulin/Insulin-like growth factor (IGF) system, which is essential for normal development, metabolism, and tissue maintenance, but is disrupted in diabetes, cancer, and inflammatory disorders. From a therapeutic perspective, insulin is widely used to treat diabetes, while drugs that block insulin or IGF activity are disappointingly ineffective in cancer. However, some of these drugs originally developed for cancer have been successfully re-purposed to treat Thyroid Eye Disease (TED) by suppressing inflammation associated with this debilitating condition. The project will investigate the basis for this success in TED and test the

rationale for this therapy in other inflammatory disorders.

The project will also aim to resolve the previously unanswerable question of how the insulin and IGF-1 receptors that evolved from a common protein and retain many similarities can mediate quite distinct biological outcomes in cells and tissues. The approach to this is made possible by newly available resources and techniques in cellular imaging, incell proteomics and computational protein modelling.

Professor O’Connor said, "This project is at the leading edge of cell signalling research. We aim to define what distinguishes the unique actions of insulin and

IGFs in health and disease. It will provide direction for new therapies for inflammatory diseases affecting millions of people."

Professor Aonghus Lavelle, Professor in Clinical Anatomy and Gastroenterologist in the Department of Anatomy & Neuroscience and APC Microbiome Ireland, has received ¤613,556 for his project entitled 'Characterising uncultured bacteria associated with bile acid dysmetabolism and disease severity in IBD.'

Professor Lavalle said, "This project will allow us to determine if these bacteria and the secondary bile acids they produce are important in the disease course

of patients with IBD. The goal will then be to establish that re-introducing these bacteria is a viable therapeutic strategy, thus opening up a new avenue for treating IBD."

Professor John F. Cryan, UCC Vice President for Research and Innovation said: "Congratulations to Professor Rosemary O’Connor and Professor Aonghus Lavalle on receiving a Research Ireland Frontiers for the Future Programme award. UCC is a world leading institution in delivering research focused solutions to major societal and healthcare challenges. These awards further strengthens UCC’s research reputation in Future Medicines, a key thematic area of our UCC Futures framework."

Vitamins Saffron Extract

Women Embarrassed to Discuss Vaginal Health

Women across Ireland are suffering in silence when it comes to their vaginal health, according to a new survey conducted by PrecisionBiotics®. The research, which polled over 1,000 women, reveals that deeprooted embarrassment is preventing open discussions, leaving many struggling with issues they feel unable to address.

The survey found that a staggering 87% of Irish women believe there is embarrassment around simply using the word "vagina" reinforcing the ongoing stigma surrounding female intimate health. As a result, 78% of women admit they would rather suffer in silence than talk about vaginal health concerns - a worrying statistic that highlights the need for more open conversations.

The research also found that embarrassment extends beyond conversation—36% of people say they would feel uncomfortable asking for a vaginal health product in a pharmacy. This discomfort is even more pronounced among younger women, with 43% of those aged 18-29 admitting they would struggle to request help in-store.

Some key findings of the study were:

• 87 percent believe that people are embarrassed about using the word “vagina”

• 84 percent agree that vaginal health is not spoken about in general conversation

• 36 percent admit they would have a problem with asking for a vaginal health product in a pharmacy, including 43 percent of 18-29 year olds

• 38 percent of the women polled are aware of and believe in the connection between gut microbiome and vaginal health

• Over half (53 percent) do not understand what the microbiome is

• 43 percent are aware that the vagina has a microbiome

• 78 percent of respondents admit that they think women in general would rather suffer in silence than mention vaginal health issues

• A quarter of the women polled say they feel worried about their intimate health impacting their physical and mental health

Commenting on the survey results, Cork based GP Dr Maeve Davis said, “We’ve come a long way in terms of having open conversations around menopause but when it comes to vaginal health, unfortunately it’s still very much taboo. A lot of my female patients find it hard to discuss intimate health, and I would really encourage open conversations about the vagina, particularly in terms of understanding the role a healthy and balanced vaginal microbiome plays in preventing unpleasant infections like thrush, which is very common and can cause a lot of distress and discomfort. I would always tell my patients to prioritise their vaginal health and never feel embarrassed about seeking advice from your doctor or pharmacist if you are worried about this.”

Women’s health advocate Catherine O’Keeffe, AKA Wellness Warrior, said: “I travel to workplaces the length and breadth of the country and the women I meet often have

issues with intimate health that they find hard to speak about, even with their doctor, let alone those close to them. There is a real taboo around this aspect of women's health and we should discuss vaginal health just as we do gut health. This research by PrecisionBiotics backs up my experiences and highlights the fact that we need to shatter taboos around discussing vaginal health and encourage women to seek treatment when needed. The time of suffering in silence is in the past.”

PrecisionBiotics, which has its roots in UCC, has launched new product Women’s Flora, designed for women who are actively seeking to maintain a healthy vaginal balance. The product has been formulated with a unique combination of scientifically studied 4 lactobacilli bacterial strains prevalent in a healthy vaginal microbiome. The company, which is known for its flagship products Alflorex and Zenflore, also recently launched ‘Good Bacteria’ on the Irish market, a daily bacterial supplement for use during or after a course of antibiotics.

Women’s health advocate Catherine O’Keeffe, AKA Wellness Warrior,

said: “I travel to workplaces the length and breadth of the country and the women I meet often have issues with intimate health that they find hard to speak about, even with their doctor, let alone those close to them. There is a real taboo around this aspect of women's health and we should discuss vaginal health just as we do gut health. This research by PrecisionBiotics backs up my experiences and highlights the fact that we need to shatter taboos around discussing vaginal health and encourage women to seek treatment when needed. The time of suffering in silence is in the past.”

Cork based GP Dr Maeve Davis, who is encouraging people to seek advice from a doctor or pharmacist if they’re worried about vaginal health

Catherine O’Keeffe, AKA Wellness Warrior, who is calling for taboos to be shattered in terms of discussing vaginal health

Adex Gel has been shown to improve atopic eczema from moderate to mild in 2 weeks without corticosteroids1

Summary of trial results

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

• from 37.14 (moderate atopic eczema) at baseline

• to 22.56 (mild atopic eczema) after 2 weeks

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

Adex Gel

Bridges the gap between plain emollients and topical corticosteroids.

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

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

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

Application of Adex Gel in the trial

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

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

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

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

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

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

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

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

80 Clinical Profiles

ASTELLAS’ PADCEVTM (ENFORTUMAB VEDOTIN) PLUS KEYTRUDA® (PEMBROLIZUMAB) SHOWS LONG-TERM EFFICACY IN FIRST-LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER (LA/MUC)

• Enfortumab vedotin plus pembrolizumab continues to demonstrate superior efficacy versus chemotherapy in a broad population, reinforcing the combination as standard of care in first-line treatment of la/muC

• At nearly 30 months of follow-up in the Phase 3 EV-302 trial, the combination doubled median overall survival and progressionfree survival compared to chemotherapy, with no new safety signals identified.

Astellas Pharma Inc. CEO: Naoki Okamura, recently announced additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of enfortumab vedotin, a Nectin-4 directed antibody-drug conjugate, plus pembrolizumab, a PD-1 inhibitor, in patients with previously untreated locally advanced or metastatic urothelial cancer (la/ mUC). The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months). This data was presented during a rapid oral session (Abstract 664) at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2025.

Thomas Powles, M.R.C.P., M.D., Professor of Genitourinary Oncology at Queen Mary University of London; Director, Barts Cancer Center, London; EV-302 Primary Investigator

“These latest findings from the EV-302 trial reaffirm the primary results, which demonstrated survival improvements for patients treated with enfortumab vedotin and pembrolizumab that were previously unprecedented in locally advanced or metastatic urothelial cancer. These data show that the potential survival benefit has become even more robust with extended follow up and further solidify the combination as standard of care.”

Results showed enfortumab vedotin plus pembrolizumab reduced the risk of death by 49% versus chemotherapy (hazard ratio [HR] = 0.51, 95% confidence interval [CI], 0.430.61). The median OS was 33.8 months for the combination versus

15.9 months for chemotherapy. The OS benefit was observed in all prespecified subgroups, including cisplatin eligible and ineligible subgroups. Enfortumab vedotin plus pembrolizumab also reduced the risk of disease progression or death by 52% versus chemotherapy (HR = 0.48, 95% CI, 0.41-0.57). The median PFS was 12.5 months for the combination versus 6.3 months for chemotherapy. The safety profile was consistent with previous findings and no new safety concerns were identified.

In addition to longer follow-up data, an exploratory analysis evaluating treatment outcomes and safety profile in patients with confirmed complete response (cCR) will also be presented. Among patients evaluable for response, confirmed objective response rate (cORR) was 67.5% for enfortumab vedotin plus pembrolizumab compared to 44.2% for chemotherapy. Median duration of response (DOR) was 23.3 months (95% CI, 17.8-not estimable [NE]) for the combination and 7.0 months (95% CI, 6.2-9.0) for chemotherapy. A cCR was achieved in 30.4% of patients treated with enfortumab vedotin plus pembrolizumab and 14.5% of patients treated with chemotherapy. Median duration of cCR was not reached for the combination and 15.2 months (95% CI, 10.3-NE) for chemotherapy. In patients with cCR, grade ≥3 treatment-related adverse events occurred in 61.7% of patients in the enfortumab vedotin plus pembrolizumab arm compared to 71.9% in the chemotherapy arm. There were no treatment-related deaths in the cCR subgroup.

Roger Dansey, M.D., Chief Oncology Officer, Pfizer

“Patients with bladder cancer can face a poor prognosis, particularly in the advanced stages, and until recently had few available treatment options. The updated EV302 results show sustained longterm efficacy in a broad population that includes both cisplatin eligible and ineligible patients and reinforce this combination’s ability to reshape the urothelial cancer treatment landscape.”

Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas

“The combination of enfortumab vedotin and pembrolizumab was the first approval to offer an alternative to platinum-containing chemotherapy, which had been the standard of care for first-line locally advanced or metastatic urothelial cancer for decades. We are delighted that the additional

follow-up results of the EV-302 trial show a durable benefit. These data represent yet another milestone in our long-standing commitment to helping patients around the world live longer and healthier lives.”

Enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with la/mUC in the United States, the European Union, Japan and a number of other countries around the world. Enfortumab vedotin is also approved as a single agent for the treatment of adult patients with la/mUC who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy.

GROUND-BREAKING RESEARCHERS FROM AROUND IRELAND HONOURED AT IRISH CANCER SOCIETY RESEARCH AWARDS 2025

People involved in groundbreaking research projects around the country were honoured at the Irish Cancer Society Research Awards on Thursday, February 20th, at the Irish Cancer Society Head Office in Ballsbridge, Dublin.

In 2024 alone, the Irish Cancer Society funded over 25 new research projects and over 180 cancer researchers.

The event, hosted by the Irish Cancer Society’s Head of Research, Dr Claire Kilty, celebrates some of the amazing work in cancer research being carried out by nominees around Ireland, funded by the Irish Cancer Society.

Among those to claim top honours were Translational and Clinical Project of the Year Award winner, Dr Karen Slattery, whose research identified new therapeutic targets for the treatment of highgrade serous ovarian cancer.

Translational research looks at

Dr Karen Slattery, Translational and Clinical Project of the Year Award winner

applying laboratory findings to real-world settings, to treat or prevent human disease.

Translational and Clinical Project of the Year Award winner, Dr Karen Slattery, said: “My research is focused on understanding how ovarian cancer impacts the immune system. We observed that ovarian cancer patients have dysfunctional immune cells, including important cancer-fighting immune cells called Natural Killer cells and T cells.

“By studying the makeup of abdominal fluid that has cancer cells from ovarian cancer patients, we were able to identify a specific type of fat molecule, known as a phospholipid, that is a key driver of this immune dysfunction.

“Importantly, blocking the uptake of this phospholipid into Natural Killer cells was able to restore their ability to kill cancer cells. These findings may guide the design of future immunotherapies for patients with advanced ovarian cancer.

“Winning this Irish Cancer Society Research Award is a deeply humbling and significant milestone in my career as a scientist. It is an honour to receive recognition for the years of hard work I’ve put into this research.

Jennifer Fitzpatrick, PhD Researcher of the Year Award winner

“Working on this project has been incredibly rewarding, and I am proud of the contribution we’ve made to the field of ovarian cancer research.”

The prize of PhD Researcher of the Year went to Jennifer Fitzpatrick. Jennifer’s project, called ‘The CHildhood and adolescent cancer survivors’ physical Activity and Movement Programme’ (CHAMPs) is a global first of its kind. The programme was developed, in collaboration with families, to support young people (aged 10 to 19 years) who have had cancer. CHAMPs is a free, personalised, 12-week physical activity programme, based entirely in the young person’s’ home and guided by their ability and interests for activity.

PhD Researcher of the Year Award winner, Jennifer Fitzpatrick, who is based in the Technological University of the Shannon, said:

“Receiving a nomination for an Irish Cancer Society Research Award is such an honour. It recognises me dedicating the last four years of my work to improving the lives of young people who have had cancer. Seeing first-hand the impact CHAMPs can have on families is incredibly emotional, but also extremely rewarding.

“I am truly grateful for the platform to develop a global first-of-its-kind programme for young people who have had cancer, but to also be recognised for this achievement is such a privilege.”

Congratulating the winners, Irish Cancer Society Head of Research Dr Claire Kilty said: “Cancer research in Ireland has a huge impact on the lives of people affected by cancer. It is a driving force in improving not only treatments and outcomes, but in quality of life beyond cancer. It was fantastic to get an appreciation of the amazing cancer research projects currently happening right across the country.

“We are proud to be the largest voluntary funder of cancer research in Ireland. However, none of the vital research we fund would be possible without the support of the public, especially on days like Daffodil Day. We would encourage everyone to please get out there and support Daffodil Day in whatever way you can on March 28th.”

ST JOHN OF GOD HOSPITAL BECOMES THE FIRST IRISH HOSPITAL TO INTRODUCE RTMS AS A TREATMENT FOR DEPRESSION

St John of God Hospital has announced the introduction of Repetitive Transactional Magnetic Stimulation therapy, in an expansion of its treatment options

for patients with depression. This non-invasive therapy offers a new option for patients who have not had sufficient success with conventional depression treatments. St John of God Hospital will be the first hospital to deliver this treatment for depression on a consultant-led basis.

rTMS is a modern treatment for depression that prioritises convenience, comfort, and safety while delivering significant benefits for those with treatment-resistant depression. rTMS uses magnetic pulses to stimulate specific brain regions, promoting the brain’s ability to form new connections and regulate mood.

Around 21 million people in Europe, or 4.5% of the population, experience depression, with higher rates in women (8.8%) than men (5.3%). In Ireland, 12% of young people (15-24 years) report chronic depression, the highest rate in Europe.

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

Consultant Psychiatrist and Head of

Neuromodulation Services Simon Mitchell, who is one of the experts leading the rollout at St John of God Hospital has commented on the announcement, saying

“The introduction of rTMS at St John of God Hospital represents significant advancement in our mental health services. This non-invasive treatment offers new hope to our patients who haven’t found relief through traditional methods. This expansion of our psychiatric services reflects St John of God Hospital’s ongoing commitment to providing the most advanced, evidence-based treatments to our patients.”

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

The typical treatment course consists of daily sessions over 4-6 weeks, with each session lasting about 20-40 minutes.

HSE HEALTH APP

The Department of Health and HSE launched the first version of the HSE Health App today. It is one of the first initiatives delivered as part of Digital for Care, Ireland’s health and social care digital framework. From today anyone aged 16 and over can download the app for free from Google Play or the App Store, however first phase functionality will be most useful for expectant mothers.

First phase functionality allows people to:

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

• store your European Health Insurance Card (EHIC), medical card, Long-term Illness card (LTI), Drugs Payment Scheme card (DPS) and GP Visit card

• access flu and COVID-19 vaccination records

• easily find information about HSE services, such as EDs and Injury Units

• view maternity service appointments (for expectant mothers)

Consultant psychiatrists, Dr Simon Mitchell and Dr Attila Szigeti with Deputy Chief Executive Sarah Almasry, Chief Executive of Saint John of God Hospital , Damien O'Dowd, and consultant psychiatrist Dr Giedrius Gerulskis at the launch of the Hospitals new rTMS service in Stillorgan

82 Clinical Profiles

A verified MyGovID is needed to access personal health information

To log in to the HSE Health App and access personal health information, you will need a verified MyGovID account. A verified MyGovID proves who you are and ensures we are giving personal health information to the right person.

If you do not have a verified MyGovID, you will still be able to use the app to find information about health conditions and HSE services.

Minister for Health, Jennifer Carroll MacNeill TD, said, “Today marks an exciting milestone in our journey to digitise patient health records with the public launch of the first version of our new HSE Health App. This App is an exciting milestone where we begin to give patients digital access to their own health information and will make it easier for everyone to navigate the health service.

aitriona Heffernan, National Clinical Innovation Lead, HSE Spark Innovation Programme; Dr Gloria Kirwan, Senior Lecturer, RCSI School of Graduate Healthcare Management; Dr Colm Foster, Director of Academic Programmes, RCSI Graduate School of Management; Sara McDonnell, Executive Director, RCSI Graduate School of Management and RCSI Online

“I know the App development team have also consulted with a number of patient organisations so that their needs are incorporated into the design process to ensure the App is patient-centred.”

The HSE is working with colleagues across government to integrate the HSE Health App with the Government Digital Wallet that will be released later this year.”

Bernard Gloster, HSE CEO, said, “There has been much progress made in modernising the data capabilities and digital technologies of our health service in recent years. The launch of the first version of the new HSE Health App represents the next step forward in our digital transformation journey, as we seek to harness the power of data and innovation to help improve access to care for patients and enhance efficiencies across services. Through utilisation and ongoing development of digital tools, such as the new HSE Health App, we see a future where our patients and the people who care for them are empowered and better informed about their care.

I will continue to ensure that we prioritise providing increased access for patients to their data and to interact with our health services to improve their experiences.”

Damien McCallion, HSE Chief Technology and Transformation Officer said, “Anyone who wishes to, can use the first version of the HSE Health App. It gives people secure access to their COVID-19 and flu vaccination records, digital medications lists, medical cards and EHIC cards, all in one place. Expectant mothers can also view upcoming maternity appointments in the app.

“This is just the beginning - the app is an evolving programme of work, with new services and features planned each year, including expanding the appointment functionality for all public hospital appointments. This is a challenging undertaking but a key priority to deliver for everyone under our care.

“The app is one aspect of the digitisation of the health service and a major priority as we face new challenges and ensure we can provide the health service the country needs and deserves.”

TEVA LAUNCHES

POMALIDOMIDE TEVA

Teva Pharmaceuticals is pleased to announce the launch of Pomalidomide Teva, available in 1mg, 2mg, 3mg and 4mg hard capsules (21 capsules).

Pomalidomide Teva indications:

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

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

For any queries or further information, please contact your local Teva representative or contact Teva on 1 800 201 700.

Further product information is available upon request or from the SmPC available at HPRA.ie.

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

Date of preparation: February 2025

Job code: GEN-IE-NP-00136

TECVAYLI®(TECLISTAMAB) BISPECIFIC ANTIBODY APPROVED FOR REIMBURSEMENT IN IRELAND FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA

Johnson & Johnson Innovative Medicine has announced that TECVAYLI® (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) has been approved for reimbursement in Ireland. Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. The announcement follows conditional marketing authorisation (CMA) from the European Commission (EC) granted in 2022 for teclistamab, a bispecific antibody that redirects CD3-positive T-cells to B-cell maturation antigen (BCMA)expressing myeloma cells to induce the killing of tumour cells.

Multiple myeloma remains an incurable blood cancer, with nearly all patients relapsing and requiring subsequent therapy. As the disease progresses, relapses for patients become more aggressive with each new line of therapy, and remissions become progressively shorter.4 Approximately, 380 people are diagnosed with multiple myeloma each year in Ireland.

Prof Siobhan Glavey, Consultant Haematologist said: "Multiple myeloma is a complex disease, and despite important scientific progress, patients who develop relapsed and refractory disease after having been exposed to three major drug classes have limited therapeutic options and generally face poor outcomes. This new treatment option has the potential to provide substantial clinical benefit and new hope to patients, with high rates of deep and durable responses as well as the added convenience of being off-the-shelf. The reimbursement of teclistamab in Ireland marks a major step towards ensuring Irish patients have access to the most innovative treatments available.”

Michaela Hagenhofer, General Manager Commercial Operations, Johnson & Johnson Innovative

Medicine Ireland said: "Our ambition to eliminate multiple myeloma is stronger today than ever before. We aim to reach this goal by investing in cutting-edge innovations that address individual patient needs and offer healthcare professionals options they have not had before. We are proud to have provided early access of teclistamab to Irish patients which not only provided valuable extra time but also allowed clinicians to gain real-world experience with a bispecific. The reimbursement of teclistamab in Ireland marks exciting progress on this journey and we are proud to bring this innovation to Irish myeloma patients.”

The approval was supported by positive results from the multicohort, open-label Phase 1/2 MajesTEC-1 study (NCT03145181 and NCT04557098), evaluating the safety and efficacy of teclistamab in adults with RRMM (n =165). Patients received a weekly subcutaneous injection of teclistamab at a dose of 1.5 mg/ kg, after receiving step-up doses of 0.06 mg/kg and 0.3 mg/kg. In the study, 104 out of 165 patients achieved an overall response rate (ORR) of 63 percent (95 percent Confidence Interval [CI]; range, 55.2–70.4) after a median of five prior lines of therapy.1 Notably, 58.8 percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better and 39.4 percent achieved a complete response (CR) or better. The median time to the first confirmed response was 1.2 months (range, 0.2–5.5 months) and the median duration of response was 18.4 months (95 percent CI; range, 14.9–not estimable).

Results from the MajesTEC-1 study were also published in The New England Journal of Medicine and showed that treatment with teclistamab resulted in deep and durable responses. The median duration of progression-free survival was 11.3 months (95 percent CI; range, 8.8–17.1) and the median duration of overall survival was 18.3 months (95 percent CI; range, 15.1–not estimable).

Adverse events (AEs) were consistent with this patient population. The most common AEs were cytokine release syndrome (72 percent; 0.6 percent Grade 3, no Grade 4), neutropenia (71 percent; 64 percent Grade 3 or 4) and anaemia (55 percent; 37 percent Grade 3 or 4). Infections were frequent with the most common being upper respiratory tract infections (37 percent; 2.4 percent Grade 3 or 4) and pneumonia (28 percent; 19 percent Grade 3 or 4). Hypogammaglobinaemia occurred

in 123 patients (75 percent) and 39 percent of patients received intravenous or subcutaneous immunoglobulin therapy. Neurotoxic events were low grade (15 percent; 14 percent Grade 1 or 2) and five patients (three percent) had immune effector cell-associated neurotoxicity syndrome.

PORTIUNCULA UNIVERSITY

HOSPITAL TO MARK WORLD KIDNEY DAY

World Kidney Day which took place on 13 March marks a global campaign aimed at raising awareness around kidney disease. This year’s theme, “Are Your Kidneys OK? Detect Early, Protect Kidney Health,” highlights the importance of recognising kidney disease risk factors as well as early detection and intervention in preventing and managing the disease.

Dr Paul O’Hara, Consultant General Physician and Nephrologist at Portiuncula University Hospital said, “World Kidney Day gives us an opportunity to stop and think about kidney disease, raise awareness of it and encourage everyone to actively know what their own kidney health measures are.

“Education is a key part of managing any chronic illness and kidney disease is no different. The risk factors associated with Chronic Kidney Disease (CKD) include diabetes, obesity, high blood pressure, long term use of over the counter medications, heart disease and family history of kidney disease. If you are over 50 or in the high risk category, it is important to get screened for CKD.”

This year to mark World Kidney Day, Portiuncula University Hospital’s kidney clinic will hold

Patient Ray Quinn from Ballinasloe with Dr Paul O’Hara, Consultant General Physician and Nephrologist and Alexandra Rose, Clinical Nurse Specialist at the Kidney Day Ward, Portiuncula University Hospital.

an information awareness stand in the outpatient department on Thursday, 13 March from 9am to 12 noon. Clinical staff will be in attendance to answer any questions you have and to raise awareness of high blood pressure, obesity and diabetes which are the leading cause of kidney disease in Ireland.

Since it opened four years ago, the hospital's kidney clinic under the remit of Dr Paul O’Hara has been providing care to patients with kidney conditions across the hospital's catchment area of East Galway and Roscommon. The kidney clinic treats a wide range of kidney conditions, with referrals from both the hospital and GPs. Between 2023 and 2024 the kidney clinic saw a 15% increase in new referrals, reviewed almost 600 patients and saw a 62% increase in patients with kidney disease receiving infusion-based therapies. Patients receiving haemodialysis and those undergoing kidney transplants are cared for at Merlin Park University Hospital.

Last month the existing kidney day ward was relocated to the new 50-bed ward block to provide additional capacity in a new clinical space, significantly enhancing patient care to the highest standards.

ALK’S ALLERGY TREATMENT ACARIZAX®(12 SQ-HDM SLIT)

NOW APPROVED FOR CHILDREN AGED 5+ IN IRELAND

ALK today announces that ACARIZAXx® has received a paediatric indication extension for the treatment of moderate to severe house dust mite allergic rhinitis disease, making it available for children aged 5 years and older in Ireland. Previously approved for patients aged 12+, this development marks a milestone in allergy treatment, broadening access to an innovative therapy that addresses the underlying cause of house dust mite allergic rhinitis.

Studies suggest that allergic rhinitis is the most common

allergic condition, affecting approximately 26% of Irish people, with house dust mites being the most common allergen. The condition can lead to disturbed sleep, impaired concentration, worsened asthma symptoms, school absenteeism and increased psychosocial burden.

ACARIZAX® is a sublingual immunotherapy (SLIT) tablet designed to treat the root cause of house dust mite allergy rather than just alleviating symptoms. By gradually desensitising the immune system, SLIT helps reduce the severity of allergic reactions over time, leading to long-term symptom relief and reduced reliance on symptomatic medications such as antihistamines and nasal steroids.

Dr Juan E Trujillo Wurttele and Dr Sadhbh Hurley together as the paediatric allergy team in Cork University Hospital and coordinators of the MSc of allergy and clinical immunology in UCC said, “House dust mite allergic rhinitis is often overlooked but can profoundly impact children’s daily lives. Expanding Acarizax’s indication to younger children represents a major step forward in addressing this unmet medical need, providing a long-term treatment option that can improve both symptoms and overall quality of life.”

ACARIZAX® has been approved for reimbursement in the UK through the NHS for the treatment of moderate to severe house dust mite allergic rhinitis disease in people 12 to 65 years that is persistent despite symptom relieving medicine, following a positive recommendation from NICE (National Institute for Health and Care Excellence). This expands access for eligible patients, providing them with a clinically proven, long-term treatment option that can significantly improve quality of life while also relieving a financial burden for patients.

ALK General Manager Emil Stage Olsen added, “This extension brings the benefits of Acarizax to younger children. This approval reflects our ongoing dedication to transforming allergy treatment and providing healthcare professionals with advanced solutions for paediatric allergic rhinitis management. It aligns with ALK’s broader mission to improve allergy management and enhance patient outcomes.”

For more information about ACARIZAX® and ALK’s commitment to allergy care, visit www.alk.net.

RECOMMEND WITH CONFIDENCE: ALFLOREX® CHILDREN

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Scientifically studied bacterial strain 35624TM

Subtle vanilla flavoured powder – easily added to milk, yoghurt and smoothies

IPN March 2025

Generic Product Launch

Fluticasone Furoate Teva

Contents

Foreword

New Digital Tool to Monitor Prescribing Trends

PMI Pharma Summit 2025

HSE Health App

Role of Pharmacy in Falsified Medicines

Body of Work to ‘Support Pharmacists’ Medicines for Ireland announces Expansion

PHX Ireland: Shaping the Future of Healthcare with Purpose, Vision,

and

People at the Core

A Purpose That Makes a Difference

A Vision for Healthier Futures

Introducing the New PHX Ireland Website

Recruiting for 5th-Year Placements NOW!

People-Centric, Purpose-Driven

Faster and Fairer Access to Medicines

Pharmacy Reforms Needed says Latest Study

Strategic Direction

Urgent Call for Digital-First Communications

HPV, Smoking and Cervical Cancer

ALLERGIES TAKING OVER YOUR LIFE?

Optimal Nutrition for Children

Strong Strong enough Stay for

with Two ... Two ...

Keeping Levels Healthy

Helping Absorption

Warning signs of iron deficiency

Anewmum: Empowering New mothers postpartum

A Commitment to Science and Support

Recognition and Future Endeavors

A Bright Future Ahead

Anewmum Product Range

Contact Information

Understanding Gut Health in Babies and Children: A Pharmacist’s Perspective

Causes of Diarrhoea in Infants and Children

Infections

Non-Infectious Causes

The Role of Probiotics

Choosing the Right Probiotics

Oral Rehydration Solutions (ORS)

Colic relief from Colief®

INFANT DROPS

Colief® Multibiotic Drops, For a happy gut

20 Children’s Digestion

Addressing Colic

The Role of Counseling

Stop Diarrhoea Fast Gentle Relief for a

Child’s

Tummy Troubles

Preconception Nutrition

Pregnancy and Contraception Care in Pharmacy

Iron for Kids.

Preconception Nutrition

Morning Sickness

Sciatica and Muscular Back Pain

DURING PREGNANCY BEFORE

AFTER

More than just folic acid Most

Impact of RSVpreF vaccination on reducing the burden of respiratory syncytial virus in infants and older adults

Results

PROTECT AGAINST RSV 3

Discussion

Generic Product Launch Fingolimod Teva

0.5 mg hard capsules fingolimod

High Tech Prescription Medicine

Indications

Get gut-ready for spring with Optibac Probiotics

Probiotics for little tummies

Baby Drops

Babies & Children

Kids Gummies

Breastfeeding and Lactation Knowledge, Attitudes and Training among Community Pharmacists in Ireland

From fever to blocked noses, Calpol has got you covered.

Advertorial

Optimizing Infant Gut Health: The Role of BioGaia Protectis Baby Drops in Managing Common Gastrointestinal Issues

Essential Nutritional Guidance for Infants: A Comprehensive Guide

for Parents and Pharmacists