IPN June 2024

June 2024 Volume 16  Issue 6 PHARMACYNEWSIRELAND.COM

THE INDEPENDENT VOICE OF PHARMACY

In this issue: NEWS: Calls for Change to Pharmacy Funding Model Page 5

MEDICINES: Supporting the needs of independent pharmacy

Patients Protected

by Pharmacists in Medicine Shortages Page 8

FEATURE: Infant Feeding Page 20

CPD:

Franchise

Independent pharmacy partner

Managing Pain and Associated Issues Page 41

AWARDS: Irish Pharmacy Awards 2024: Winners Page 47

RESEARCH: New Survey on Asthma Page 88

TEAM TRAINING: Erectile Dysfunction Page 92 This Publication is for Healthcare Professionals Only

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3

Contents

Foreword

Page 4: Pharmacy welcomes Digital Health Framework

In one of our lead news stories, we detail how the newly elected President of the Irish Pharmacy Union, Tom Murray has called for a new funding model for Ireland’s pharmacies, which he says is long overdue and needs to be implemented as a ‘matter of priority.’

Page 6: Meaghers launches Pharmacy 360 Innovation Page 8: Addressing Medicine Shortages and the role of Pharmacy

4

Page 11: Luda Partners revolutionising pharmacy online sales

Turn to page 5 to read more.

Page 14: Fox’s Pharmacy gain an extra pharmacy day Page 24: Making everyone Epilepsy Aware Page 26: Insights into considerations when purchasing OTC medicines

8

Page 47: All the winners from the 2024 Irish Pharmacy Awards

EDITOR Kelly Jo Eastwood: 00353 (87)737 6308 kelly-jo@ipn.ie SALES MANAGER Amy Evans | amy@ipn.ie 0872799317 ADVERTISING EXECUTIVE Esther Elliott-Coulter: 00353 (87) 062 2025 Esther@ipn.ie EDITORIAL/ EVENTS & MARKETING EXECUTIVE Aoife Hunter: aoife@ipn.ie CONTRIBUTORS Barbara Paldus Dr Genevieve Ferraris Marie Richardson Marie Duffy Dr Christine Glendinning Dr Patrick Treacy Paddy McGeoghegan Denise McGuinness DESIGN DIRECTOR Ian Stoddart Design PHARMACYNEWSIRELAND.COM @Irish_PharmNews IrishPharmacyNews

On page 8, it is revealed that the problem of medicine shortages remains high, with a latest survey revealing that every pharmacy in Ireland has been challenged by medicine shortages in the past four months. In the 12 month The IPU Medicine Shortage Survey found that all pharmacists have experienced medicine shortages in the last 4 months with a considerable 57% (60% in 2023) of pharmacies experiencing more than 40 medicine shortages in that period.

Meanwhile, Medicines for Ireland (MFI), the leading representative body for the generic, biosimilar, and valueadded medicines industry, is highlighting the urgent need for action to address the increasing medicine shortages affecting the Irish population. A recent Red C survey reveals a concerning trend: 1 in 5 (20%) of individuals have been personally affected by medicine shortages in the past two years.

PUBLISHER: IPN Communications Ireland Ltd. Clifton House, Fitzwilliam Street Lower, Dublin 2 00353 (01) 6690562 MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com

“The establishment of an Expert Taskforce on the future of pharmacy was a milestone moment,” Mr Murray said. “The role of pharmacists will change as a result and our profession is ready and excited to do so. These changes should include independent prescribing powers, the provision of a service for common clinical conditions and enhanced contraceptive care. The potential arising from all of this is immense for patient care.”

14

Awards The Irish Pharmacy

2024

This issue also carries all the winners from the 2024 Irish Pharmacy Awards. What an amazing night was had by all. The Irish Pharmacy Awards honour the exceptional dedication, innovation and commitment demonstrated by pharmacists and their teams across Ireland.

The night proved to be a celebration of remarkable achievements and gave everyone a chance to reflect on the importance of collaboration, continuous learning and the pursuit of excellence in their profession.

47 Irish Pharmacy IRISH News is PHARMACY circulated to all NEWS 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.

Turn to page 46 for all the details and make sure you save the date for the next one – Saturday May 24th, 2025.

I hope you enjoy the issue.

Regulars FEATURE: ACNE

P34

CPD: MANAGING PAIN

P41

FEATURE: MENOPAUSE

P72

TEAM TRAINING: ERECTILE DYSFUNCTION

P92

CLINICAL PR:

P96

PHARMACYNEWSIRELAND.COM

4

News

Pharmacy Welcomes Government Digital Health Framework The Irish Pharmacy Union (IPU) has welcomed the Digital Health Framework for Ireland 2024-2030 launched last month. This new framework is a critical step forward in addressing Ireland’s outdated technologies and the inefficiencies that have long impacted our health system. The organisation highlighted in particular the dot matrix printers currently used across our health systems which need to be urgently relegated into the past.

Stephen Donnelly, Minister for Health at the IPU Conference

pharmacists must now print an average of 78 million pieces of paper annually, the cost and time of which has been foisted upon pharmacies. Says the IPU, “We cannot wait any longer for basic IT initiatives to address this problem.”

The 2013 eHealth Strategy for Ireland laid the foundation for significant advancements in digital healthcare. Over the past decade, community pharmacies have embraced new technologies, ensuring patients continue to receive timely and accurate care. Progress, however, has been significantly hindered by a lack of interoperable HSE systems resulting in significant administrative burdens for community pharmacists and other healthcare providers.

Since the introduction of Healthmail, for instance,

Speaking at the IPU National Pharmacy Conference in April, Stephen Donnelly, Minister for Health T.D. said, “It is simply not acceptable to have all of you having to do the level of paperwork, the level of repetition that is required. It gets discussed as probity and good clinical governance. And of course we need good clinical governance.

But there is a lot of that that has just built up. It is just bureaucratic creep. And rather than redesigning a process, you know, everything, new thing that needs to happen, just more and more red tape, more and more paperwork gets added. The dot matrix printers are still there.

“So, I am going to direct my department and the HSE to immediately commence a process of reviewing all of that paperwork, all of that bureaucracy in the round with a view to substantially reducing it and getting rid of the dot matrix printers.”

Noel Stenson, Chair of the IPU IT Steering Group, expressed support for the new framework: "The Digital Health Framework 2024-2030 marks an important moment for healthcare in Ireland.

By integrating community pharmacies into the national digital health infrastructure, we can significantly enhance patient care and safety, by moving from resource hungry manual processes, and freeing time for valuable patient interactions.

The framework's emphasis on expanding ePharmacy services and patient engagement aligns with our mission to provide accessible and efficient healthcare.

We are committed to supporting the implementation of these initiatives within pharmacies, and ensuring that pharmacists have the investment, tools and the training needed to fully leverage these advancements."

Expansion of Role of Pharmacists PSI, The Pharmacy Regulator, has welcomed announcement of a public consultation on the expansion of the role of pharmacists by Minister for Health Stephen Donnelly TD. The public consultation offers an opportunity for the public and interested parties to provide views on further expansion of services provided by pharmacists that could offer further benefits to public health and patient engagement. The PSI encourages members of the public, pharmacists and other health and social care professionals to participate.

The announcement of the public consultation follows on from the Minister’s establishment of the Expert Taskforce in July last, to support the expansion of the role of pharmacists in Ireland, of which the PSI is an active member.

As the regulatory authority for pharmacy in Ireland, the PSI plays a critical role in ensuring pharmacists expertise and contribution as part of the wider health service continues to develop in line with evolving patient care and innovations in the sector.

The PSI Registrar and Chief Officer, Joanne Kissane said, “Pharmacists play a critical role within the health system and have a long-held desire to build and expand upon their unique role. The Expert Taskforce is committed to taking a collaborative approach to its work and this public consultation ensures all views and insights can be considered as part of the development of future pharmacy services. We welcome the consultation and strongly encourage members of the public,

PHARMACYNEWSIRELAND.COM

Chronic Pain Pilot A new HSE occupational therapy service is aiming to help hundreds of people every year who are currently unable to work due to chronic pain or musculoskeletal conditions to remain in, or return to, employment.

Already in action across a number of regions including Waterford, Kildare, Wexford, Kilkenny, Dublin South/South East and Wicklow this pilot service of community-delivered occupational therapy is currently delivering support to people with musculoskeletal disorders (MSDs) and arthritis. It is focused on people currently in paid employment or in receipt of illness benefit. This service has the potential to help over 450 people every year reach their goal of staying in work or returning to their job.

Previous research has shown 14 million days are lost each year due to absence and ill health in the workforce, with half of those attributable to MSDs. This is coupled with an over ¤750 million cost to the economy.

Speaking about the Work-Able Solutions programme Professor David Kane, Clinical Lead for Rheumatology, HSE says: “We know from research that many people who exit employment due to chronic pain never return and only 2% of those on long term disability leave that payment.”

Project Lead and Occupational Therapy Lead for Rheumatology, Dr Yvonne Codd, HSE continues: “Our new programme aims to aid people living with chronic pain to maintain or return to employment again. In our short existence we have already seen the benefits of our approach.”

our registrants and others within the healthcare sector to participate in the process.”

Jane Brownlee, Clinical Specialist Occupational Therapist, Rheumatology, HSE added:

The public consultation is seeking views on the expansion of the role of pharmacists, services offered to the public, and the interaction of pharmacy services with healthcare.

The Minister for Health is calling for contributions to be made by Irish registered medical practitioner, health, and social care professional organisations, as well as members of the public via an online survey.

“Managing chronic pain while trying to sustain employment can be very difficult. My role is to work with clients on a one-toone basis to provide a flexible, solutions-based approach.

Our service focuses on setting goals and identifying treatment plans which give people the confidence to continue, or return to the workforce.”

News Calls for Chief Pharmaceutical Officer The Irish Pharmacy Union (IPU) has reiterated its call for the Minister for Health to promptly appoint a Chief Pharmaceutical Officer (CPO) within his department. This call was overwhelmingly supported at the Association’s AGM, where a motion on the subject was debated and unanimously approved.

In addressing this motion Liam Butler Vice-President of the IPU’s Pharmacy Contractors Committee emphasised the crucial role of community pharmacists in providing local healthcare. He highlighted that the IPU has consistently advocated for the role of a CPO stressing that without this key position the full potential of pharmacy cannot be realised.

“The appointment of a CPO would ensure that the pharmaceutical care of our population and medicine supply is consistently addressed at the most senior levels of the health system. It would also facilitate the development of a strategic vision for communitybased pharmacy care, ultimately enhancing patient services.”

Despite progress in expanding pharmacist roles, the absence of a CPO undermines a proper vision for pharmacy services.

This is evident in the lack of parity with other Chief Officers in the Department of Health, such as a Chief Medical Officer and the Chief Nursing Officer.

To advocate effectively for pharmacists and maximise their contributions to the healthcare system, pharmacy representation at the highest levels is imperative, as is seen in neighbouring jurisdictions like England, Scotland and Northern Ireland.

“The absence of an Irish CPO places is at odds with modern healthcare systems. Jurisdictions that have a CPO have clearly demonstrated their value.

For example, pharmacists in Scotland operate according to a clear national pharmacy strategy which is integrated into the wider health service.

Through this simple but effective structure, pharmacists’ specialist knowledge in medicines is utilised to best effect for people’s health and well-being. We need to take a similar approach here.”

5

IPU President Calls for New Funding Model A new funding model for Ireland’s pharmacies is long overdue and needs to be implemented as a matter of priority. This was a central message from the newly elected President of the Irish Pharmacy Union (IPU) Donegal-based Tom Murray, who has worked as a community pharmacist for 23 years bringing extensive experience to his new role.

Addressing pharmacists at the National Pharmacy Conference in Athlone, which was attended

by Minister for Health Stephen Donnelly, Mr Murray, while acknowledging significant momentum in efforts to expand Irish pharmacy services, emphasised the pressing need for a revised funding model. He stated that while pharmacists are optimistic about plans to expand the sector, this expansion must come in tandem with adequate funding.

“The establishment of an Expert Taskforce on the future of pharmacy was a milestone moment,” Mr Murray said. The role of pharmacists will change as a result and our profession is ready and excited to do so.

These changes should include independent prescribing powers, the provision of a service for common clinical conditions and enhanced contraceptive care.

“The potential arising from all of this is immense for patient care.

The expansion of pharmacy services will result in increased accessibility to healthcare, which will improve patient outcomes.

New Irish Pharmacy Union President, Tom Murray

Implementing a serious shortages protocol will reduce waiting times for medicines in short supply.”

However, despite the profession’s positive outlook toward this expansion Mr Murray warned that many pharmacies are at ‘breaking point’ due to the current funding model. “80% of Community Pharmacists’ time is devoted to state services in administering the community drug schemes. Last year pharmacists dispensed over 80 million medicines on behalf of the state. The fees paid for providing this vital service have been frozen for 16 years, while every other service provider, professional and employee in the Health Sector, has had increased payments.

“As a result of a draconian and regressive tiered fee structure,

and in the face of rising costs, pharmacies are dispensing at a loss for significant portions of each month when providing state services. As a result, every single pharmacy is now subsidising the state through their private business. This is unsustainable and cannot continue.”

Concluding, Mr Murray urged the Minister for Health to deliver progress on these issues.

New Opening at HealthPoint Pharmacy Keane’s HealthPoint Pharmacy has officially opened its new location on Main Street, Enfield after trading for 18 years on Johnstown Road. employs eight people locally and welcomes new patients.

Owner and Pharmacist John Keane commented, "We have successfully traded in Enfield for the last 18 years, and we now look forward to the next 18 years in a location that embodies our company values of providing bestin-class care and convenience for our customers."

Pharmacist and Store Manager Mark Coyne said, "Entering a new space allowed us to redesign the store for both team comfort and customer convenience. Our new store is much more comfortable for our expanded team, and we can now serve our customers in

a more convenient and confidential setting."

The new store features free twohour parking at the back and is situated in a more convenient location, closer to other businesses in the area. The pharmacy currently

Pharmaton brand ambassador and Operation Transformation star Karl Henry officially cut the ribbon at the opening ceremony. Karl praised the quality of the store and service, highlighting the benefits of a family-run business.

The team would like to thank Karl Henry, Clonmel Healthcare and United Drug, as well as the entire HealthPoint pharmacy team.

PHARMACYNEWSIRELAND.COM

6

News

Meaghers Launches Pharmacy 360 Meaghers Pharmacy Group has launched Pharmacy 360, a new innovation which will transform the way in which it interacts with patients.

Oonagh O'Hagan, MD of Meaghers Pharmacy Group

approach to health goes hand in hand with traditional pharmacy.

Oonagh O’Hagan, Managing Director of Meaghers Pharmacy Group, said, “We are delighted that Pharmacy 360 has been announced as a finalist at the Irish Pharmacy Awards 2024. Meaghers is very much a community pharmacy and this new initiative is another way for us to support our community; to show customers that they are not on their own and that they don’t need to be isolated.

It is about all of our pharmacists taking that extra time to talk to the patient and see what other factors they can be helped with rather than just dispensing the medication.

Pharmacy 360 is a new holistic health initiative created as a support to patients’ treatment plans to complement the medication they are being prescribed – taking the whole person into consideration.

Although just launched, this innovative initiative has been announced as a finalist in the Irish Pharmacy Awards 2024.

Pharmacy 360 was a finalist in the BOI Payment Acceptance (BOIPA) Innovation & Service Development (Chain) Award category.

With Pharmacy 360, patients will be advised on how techniques to improve other factors that might be adding to their conditions – such as sleep, nutrition and anxiety.

Meaghers’ experts will be used to educate patients in order to enhance their health.

already been trialled in a number of Meaghers pharmacies and has received very positive feedback.

The new initiative brings the expertise of senior Meaghers Pharmacy Group staff to bear on seven separate areas. They are: Sleep, Nutrition, Movement & Exercise, Stress Resilience, Relationships, Environment and Core Values.

“Meaghers Pharmacy Group is delighted to be launching Pharmacy 360 as an enhanced support for our customers across all our branches and our online operation. In no way is it meant to replace medicine but to compliment treatment plans. The ways and means in which people can maintain optimum health vary at different stages in life and when managing different conditions.

Pharmacy 360 aims to support our customers in managing their medical conditions in the best and most informed way possible.”

Soul Space co-founder founder and qualified pharmacist Miriam Hussey, who is also an integrative health and wellness coach, has been announced as Brand Ambassador for Pharmacy 360.

Pharmacy 360 will be available to all customers in both Meaghers Pharmacy Group stores across Dublin as well as online at www. meagherspharmacy.ie It has

Pharmacy 360 will create a greater connection with Meaghers’ customers and expand the role of the pharmacist in the community.

It will showcase how a holistic

PHARMACYNEWSIRELAND.COM

A new global intelligence report from FIP, published last month, gives the most extensive and representative overview of how the role of pharmacists in vaccination has evolved to date.

The report, “Leveraging pharmacy to deliver life-course vaccination”, is based on a new survey of 73 countries and integrates evidence gathered by FIP in 2016, 2019/20 and 2022, providing a comprehensive picture across 120 countries and territories.

“Pharmacy-based vaccination is now authorised in at least 56 countries, with 22 countries identified as allowing these services since 2020.

Immunisation against vaccinepreventable communicable diseases not only reduces morbidity and mortality, it decreases pressure on health care systems. It is an important contributor to universal health coverage,” said Professor Ian Bates, director, FIP Global Pharmaceutical Observatory.

Findings on a variety of pharmacist-led immunisation schemes are presented in this new FIP resource, including advocacy activities, regulatory frameworks, vaccine administration and prescribing, training and certification, maintenance of vaccination records, reimbursement for vaccination services, and public satisfaction as well as highlighting challenges to service expansion.

This study forms part of the FIP Vaccination Surveillance Project, an ongoing initiative aimed at continuously monitoring and assessing the development of pharmacists’ roles in immunisation globally. The ongoing collection of this data from FIP members is important because it establishes a strong base from which members can advocate for supportive policies, regulations and the broader inclusion of pharmacists in vaccination strategies in their nations.

Each of seven separate headings will be addressed in a range of ways — from a pharmacological, lifestyle, and holistic perspective by pharmacist and MD Oonagh O’Hagan, Joanne O’Hagan and integrative health specialist Liz O’Hagan.

Oonagh O’Hagan will be providing the pharmacy focus outlining how pharmacists can help patients to manage their conditions and improve health outcomes, Joanne will show Meaghers customers how they can make the right lifestyle choices, and Liz will provide information on the importance of holistic health in the pharmacy space.

Increase in Pharmacy Vaccination

The report is accompanied by a global online atlas offering an interactive means of exploring the progress and status of pharmacists’ roles in vaccination services.

Pharmacist and Integrated Health Expert Miriam Hussey

Looking forward, FIP says it is eager to advance the implementation of its policy on the role of pharmacists in life-course immunisation.

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8

Medicines

Patients Protected by Pharmacist Positive Work in Addressing Medicine Shortages The problem of medicine shortages remains high, with a latest IPU annual survey revealing that every pharmacy in Ireland has been challenged by medicine shortages in the past four months. The Irish Pharmacy Union (IPU) has said this highlights the need to expedite the planned introduction of a serious shortage protocol under the Health Miscellaneous Bill for all molecules in short supply, and ensure that the legislation will be flexible enough to find solutions for patients.

Vice Chair of Medicines for Ireland, Deirdre Kelly

certain steroid creams used to treat eczema, ADHD medication and Ozempic. Medicine availability issues have potential to impact medical conditions and can create considerable stress and inconvenience to patients.

In the 12 month The IPU Medicine Shortage Survey found that all pharmacists have experienced medicine shortages in the last 4 months with a considerable 57% (60% in 2023) of pharmacies experiencing more than 40 medicine shortages in that period.

Among the key findings of the Irish Pharmacy Union’s (IPU) Medicine Shortage Survey are: 1. 84% of pharmacists expect this problem to increase over the next 12 months.

2. Irish community pharmacists are spending over 4 hours 37 minutes per week managing medicine shortages, work that often goes unnoticed and not recompensed.

3. 62% believe that allocations imposed by manufacturers is the leading cause of medicine shortages.

Medicine shortages can have a serious impact on patients and their families according to Clare Fitzell, IPU’s Head of Strategic Policy. “Behind each medicine that is in short supply are patients who need them for their health and wellbeing. Medications in short supply this year have included

“Pharmacists are highly experienced and work with prescribers to source alternatives where required. However, this process is often time consuming for healthcare providers and takes too long for patients.

The amount of time spent by pharmacies on dealing with shortages has increased significantly since 2018. The average pharmacist spends 4 hours 37 minutes per week dealing with shortages, in 2018, 5-10 hours per month was more typical.

“There is no expectation that this problem will improve in the next year with 84% of pharmacists surveyed predicting it will get worse”, Ms Fitzell said. “This is a global problem and therefore we must look at what Ireland can control and implement this rapidly.

In particular, moves to introduce a Serious Shortage Protocol must be expedited to ensure effective use of healthcare professional resource.”

The Health Miscellaneous Provisions Bill 2024 is currently before the Oireachtas. This will allow the Minister for Health to introduce a scheme where pharmacists can appropriate substitute medicines for patients without needing to revert to the prescribing doctor. “This should dramatically speed up the process for both pharmacists and prescribers and crucially will ensure that patients get appropriate medicines quicker.”

PHARMACYNEWSIRELAND.COM

Concluding, Ms Fitzell said, “Medicine shortages are a growing and significant problem. The focus in Ireland should be to address what is in our own control and how we can best support patients. There are very obvious and beneficial proposals that can be introduced, and the patients of Ireland cannot afford for these to be delayed any longer.”

• Policies that incentivise the use of generic medicines, ensuring access to affordable, high-quality, and essential medications.

Meanwhile, Medicines for Ireland (MFI), the leading representative body for the generic, biosimilar, and value added medicines industry, is highlighting the urgent need for action to address the increasing medicine shortages affecting the Irish population.

• Create a streamlined regulatory and reimbursement pathway for value-added medicines, allowing for medicine repurposing and aligning Ireland with other leading European nations.

A recent Red C survey reveals a concerning trend: 1 in 5 (20%) of individuals have been personally affected by medicine shortages in the past two years. Additionally, 22% report that family members or friends have been impacted totalling 38% of the population either directly or indirectly experiencing the consequences of these shortages.

Commenting on the Red C survey results, Chair of Medicines for Ireland Paul Neill said, “The growing scarcity of essential medicines is more than an inconvenience; it’s a barrier to health and well-being. With 38% of those surveyed expressing that shortages have impacted them or someone close to them, it is a clear and urgent signal that our healthcare system faces a crisis that requires immediate action.”

The impact is felt across various medical treatments, with pain relief medication shortages affecting nearly 2 in 5 (37%) of those impacted. Other areas, such as respiratory, gastroenterology, and rheumatology treatments, also face significant challenges.

Medicines for Ireland, a solutionsfocused organisation, is proposing a multifaceted approach to address these shortages: • Implement dynamic pricing policies that encourage competition.

• Evolve the best-value biologics (BVB) process to ensure the sustainability of best-value medicines and best-value biologics.

Mr Neill emphasises, “There is no single simple solution to addressing the challenges leading to medicine shortages, but we have detailed the solutions that MFI and our members believe can address these challenges in our five-year vision, Looking forward: Building the framework for a sustainable generic, biosimilar and value-added medicines industry in Ireland. By adopting these solutions, we can mitigate the impact of shortages and ensure a robust supply of medicines for all who need them.

“By encouraging the use of generic, biosimilar and value added medicines, we can alleviate the strain on our healthcare system. It’s not just about cost savings; it’s about ensuring that every patient has access to the medicines they need when they need them. Establishing a sustainable pathway for biosimilar medicines and a streamlined regulatory process for valueadded medicines are critical steps towards a more resilient healthcare system.”

Vice Chair of Medicines for Ireland Deirdre Kelly commented, “Patients are often left waiting, revisiting pharmacies, or accepting alternatives. This is not the standard of care we strive for in Ireland. This data shows that nearly half (49%) of the population recognises the worsening of this issue over the past two years.”

The Medicines Management Programme (MMP) recommends Tetridar ® as a Best Value Medicine (BVM) for teriparatide on the High Tech Arrangement.

Tetridar

®

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Indications Tetridar® is indicated in adults.

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture.

In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated.

Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

Further information available from the SmPC available at HPRA.ie Tetridar® (teriparatide) 20 micrograms/SO microlitres Solution for Injection in pre-filled pen Abbreviated Prescribing Information.

Presentation: Each dose of 80 microlitres contains 20 micrograms of teriparatide. One pre-filled pen of 2.4 ml contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml).

Indications: Tetridar is indicated in adults for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated.

Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. Dosage and administration: The recommended dose of Tetridar is 20 micrograms administered once daily. The maximum total duration of treatment with Tetridar should be 24 months and the 24-month course of teriparatide should not be repeated over a patient's lifetime. Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate. Following cessation of teriparatide therapy, patients may be continued on other osteoporosis therapies. Adults: Teriparatide should be administered once daily by subcutaneous injection in the thigh or abdomen. Patients must be trained to use the proper injection techniques and correct use of the pen. Until further clinical data become available, the recommended treatment time of 24 months should not be exceeded. Children: The safety and efficacy of teriparatide in children and adolescents less than 18 years has not been established.

Teriparatide should not be used in paediatric patients or young adults with open epiphyses. Elderly: No dosage adjustment required. Renal impairment: Teriparatide must not be used in patients with severe renal impairment. In patients with moderate renal impairment, teriparatide should be used with caution. No special caution is required for patients with mild renal impairment. Hepatic impairment: teriparatide should be used with caution in hepatically impaired patients, as no data are available. Contraindications: Hypersensitivity to the active substance or to any of the excipients, Pregnancy and breast-feeding, Pre-existing hypercalcaemia, Severe renal impairment, Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis, Unexplained elevations of alkaline phosphatase, Prior external beam or implant radiation therapy to the skeleton, Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide. Precautions and warnings: In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Blood samples for serum calcium measurements should be taken at least 16 hours after the most recent Tetridar injection. Tetridar may cause small increases in urinary calcium excretion. Tetridar has not been studied in patients with active urolithiasis, therefore should be used in caution in patients with active or recent urolithiasis due to potential exacerbation of this condition.

In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses. Experience in the younger adult population, including

Teva Pharmaceuticals Ireland, Digital Office Centre Swords, Suite 101 - 103, Balheary Demesne, Balheary Road, Swords, Co Dublin, K67ESAO, Ireland.

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

Prescription Only Medicine.

premenopausal women, is limited. Treatment should only be initiated if the benefit clearly outweighs risks in this population. Interactions: In a study of 15 healthy subjects administered digoxin daily to steady state, a single teriparatide dose did not alter the cardiac effect of digoxin.

However, sporadic case reports have suggested that hypercalcaemia may predispose patients to digitalis toxicity. Because teriparatide transiently increases serum calcium, teriparatide should be used with caution in patients taking digitalis. Teriparatide has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide. No clinically significant interactions were noted.

Co-administration of raloxifene or hormone replacement therapy with teriparatide did not alter the effects of teriparatide on serum or urine calcium or on clinical adverse events. Pregnancy and lactation: Women of childbearing potential should use effective methods of contraception during use of Tetridar. If pregnancy occurs, Tetridar should be discontinued. Tetridar is contraindicated for use during pregnancy and breastfeeding. It is not known whether teriparatide is excreted in human milk. Animal studies have shown reproductive toxicity. The effect of teriparatide on human foetal development has not been studied. The potential risk for humans is unknown. Effects on ability to drive and use machines: Tetridar has no or negligible influence on the ability to drive and use machines. Transient, orthostatic hypotension or dizziness was observed in some patients. These patients should refrain from driving or the use of machines until symptoms have subsided. Adverse reactions: Anaphylaxis, serious cases of back pain have been reported within minutes of the injection, syncope, hiatus hernia, nephrolithiasis, renal failure and renal impairment. Very Common: pain in limb; Common: anaemia, hypercholesterolaemia, depression, dizziness, headache, sciatica, vertigo, palpitations, hypotension, dyspnoea, nausea, vomiting, gastroesophageal reflux disease, sweating increased, muscle cramps, fatigue, chest pain, asthenia, mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritus and minor bleeding at injection site. Consult the Summary of Product Characteristics in relation to other side effects.

Overdose: The effects of overdose that might be expected include delayed hypercalcaemia and risk of orthostatic hypotension, nausea, vomiting, dizziness, and headache. No fatalities associated with overdose have been reported. There is no specific antidote for Tetridar. Treatment of suspected overdose should include transitory discontinuation of Tetridar, monitoring of serum calcium, and implementation of appropriate supportive measures, such as hydration. Legal category: Medicinal product subject to medical prescription. Marketing Authorisation Number: PA1986/053/001.

Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands. Job Code: MED-IE-00060. Date of Preparation: May 2022.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com Date of Preparation: December 2023 Job Code: GEN-IE-00054

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

te a

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Medicines

Medicines for Ireland unveils its Manifesto for Europe Suppliers of generic, biosimilar, and value-added medicines call for reform of EU pharmaceutical laws to ensure equitable access to treatments for all patients.

Chair of MFI, Paul Neill

biosimilar, and value-added medicines in the Irish market.

Under the direction of the 10th European Parliament, we urgently need to see EU pharmaceutical laws reformed to drive greater competition, and support investment in affordable off-patent innovation.

Increased penetration of generic, biosimilar, and value-added medicines will be critical to enhancing treatment accessibility for patients, while managing the healthcare spend of EU member states. That’s the message from Medicines for Ireland (MFI) to European election candidates in its ‘Manifesto for Europe’ setting out the association’s key European policy asks.

In its manifesto MFI is calling for: 1. Equitable access to essential medicines through the introduction of pro-competitive measures that ensure early entry of generic, biosimilar, and value-added medicines into the Irish market.

2. Safeguarding of Europe’s pharmaceutical production through the adoption of a Critical Medicines Act to bolster manufacturing competitiveness, mitigate supply risks, and support investments in

cutting-edge, sustainable manufacturing technologies and workforce upskilling.

3. The establishment of a contemporary regulatory framework to keep pace with scientific and technological progress by fast-tracking digital and regulatory efficiency measures within new EU pharmaceutical legislation.

4. Promotion of healthcare innovation through the introduction of legislative measures that reward innovation while ensuring affordability.

Commenting, Chair of MFI, Paul Neill said: “Access, affordability, and availability are central to our future vision of healthcare in Ireland and must be championed in Europe by our new cohort of Irish MEPs. Pro-competitive measures in EU pharmaceutical and intellectual property legislation, need to act as a key enabler to facilitating earlier entry of generic,

PHARMACYNEWSIRELAND.COM

“A shift in policy thinking is also required to secure availability of medicines for patients which is a challenge members states, including Ireland continue to grapple with. Fostering timely competition and sustainable uptake of generic, biosimilar, and value-added medicines would significantly help shape a future where shortages are an exception rather than the norm. Furthermore, we would like to see the adoption of a Critical Medicines Act to promote open strategic autonomy in healthcare and restore medicines manufacturing competitiveness across Europe.

This in turn would reduce dependency risks for essential medicines, also easing pressures on supply.”

Irish patients endure. Irish MEPs will play a pivotal role in the future policy development and implementation that impacts national health systems and the well-being of citizens in Ireland and across Europe.

“As part of this, we need to see fast-tracking of digital and regulatory efficiency measures within new EU pharmaceutical legislation, recognising the urgency of modern healthcare needs. We are calling on Irish MEPs to pursue measures that enable regulatory flexibility to prevent shortages, including spearheading the swift adoption of Electronic Product Information Leaflets (EPIL). This goes hand in hand with the establishment of a viable shortage prevention and mitigation policy.”

Ms Kelly concluded: “In reforming EU pharmaceutical legislation we want the bolar clause exemption to be explicit on facilitating any activities that need to be undertaken to allow generic or biosimilar medicines launch immediately after the expiry of an originator patent. Furthermore, the definition of repurposed medicines needs to be expanded beyond new indicators to include value-added medicines. These issues are of utmost importance for health systems to realise increased value from their medicine spend and to broaden patient access to medicines.”

MFI has continuously advocated for legislative reforms that guarantee every patient in Ireland and across Europe has access to the essential medicines they need.

The associations policy asks, aim to secure a regulatory environment that keeps pace with science and technology evolution, ensuring Irish patients have early access to new medical innovations.

MFI’s ‘Manifesto for Ireland’ asks align with those made by its European sister association Medicines for Europe (MFE), which will host its 30th Anniversary Annual Conference in Dublin from 12th – 13th June. The themes of the upcoming conference resonate with the pillars of MFI’s manifesto, focusing on access to medicines, innovation, and sustainable healthcare solutions. The conference will serve as a platform to further these discussions, fostering collaboration and progress towards a healthier Europe.

Commenting, Vice-Chair of MFI, Deirdre Kelly said: “The forthcoming European elections hold significant weight in shaping the future of health policy in Europe, a factor that directly influences the levels of shortages

MFI member companies include Accord Healthcare, Celltrion Healthcare, Clonmel Healthcare, Consilient Health, Fannin, Fresenius Kabi, Pinewood Healthcare, Sandoz trading as Rowex, Teva, and Viatris.

News

11

Increasing Online Pharmacy Sales LUDA Partners, a Spanish-based start-up has brought its technology, expertise and digital network to Ireland since the beginning of March this year. The company was founded by and for pharmacists, in 2017 to assist the pharmaceutical sector. It has revolutionised the way pharmacies sell online by helping them to increase their online sales with established partners such pharmaceutical companies, marketplaces and quick commerce platforms with ongoing online presence. With this win-win approach, LUDA Partners allows pharmacies to expand their reach without needing any technical expertise or additional resources.

Now, with a network of more than 3,700 pharmacies, over 340,000 product references across Spain, LUDA Partners has decided to expand its operations to serve the international pharmacy community and equip Irish pharmacists with digital opportunities to boost their online sales through new channels.

The company has a successful track record in the Spanish market and its entry into Ireland is expected to bring similar results. By partnering with local pharmacies, LUDA Partners is not only helping them to evolve but also to thrive in the digital world.

Revolutionising Pharmacy Services The future of pharmacy is undoubtedly digital, and LUDA Partners has been at the forefront of this transformation. As Irish pharmacies begin to adapt to consumers’ digital habits, the benefits will become increasingly apparent. From customer satisfaction to improved operational efficiency, the digitalisation of pharmacies holds immense potential. This can lead to a more responsive sales service overall.

Empowering Local Pharmacies LUDA Partners' entry into the Irish market comes at a particularly convenient moment. Many local pharmacies are currently facing the dual challenges of retaining their existing customer base while also attracting new clients in an increasingly digital-first world.

LUDA Partners is a technology company which helps pharmacies boost their online sales

So far, LUDA Partners has proven to be an attractive ally for local pharmacies. Currently, over 30 Irish pharmacies are relying on them in cities such as Dublin, Cork, Waterford, Limerick, Galway, Kilkenny and Ennis but their digital network keeps expanding.

At the same time, the company has enlarged its network with the support of its partner, Just Eat. Both businesses have a current collaboration to launch a new vertical for pharmacies to amplify their online presence. Within this channel, pharmacies have the opportunity to sell a variety of pharmacy categories like first aid, baby food, sexual health, hygiene and cosmetic products, among others, with no digital knowledge needed.

Here's how LUDA Partners empowers Irish pharmacists to start online selling:  Expanded Reach and Visibility: Pharmacies gain access to 1.1 million customers across Ireland, significantly enhancing their online visibility.  Increased Revenue: The average billing through this new channel is ¤2,700, providing a boost to overall revenue.  Business Awareness: Ensuring that pharmacies are top-of-mind when customers are searching for pharmacy products in over 40 delivery zones.  Effortless Setup: The digital network integrates seamlessly into existing pharmacy operations, ensuring a smooth and efficient transition to online sales without prior digital knowledge.

 No Fixed or Installation Cost: LUDA takes care of the logistics.

It has a dedicated team ready to assist pharmacies in transitioning to online sales.

Enhancing Competitiveness The company is aware that pharmacies play an important role in the Irish community. With that said, LUDA Partners is committed to improving their benefits in the digital landscape by guiding them step by step.

As more pharmacies go online, they can stay relevant and competitive in an increasingly digital era while sharing their guidance and services with their customers. Also, by joining LUDA’s digital ecosystem, pharmacists have more chances to get the most out of it by starting selling their pharmacy products on platforms such as e-commerce, quick commerce and marketplace.

LUDA’s partnership also enables pharmacies to sell overthe-counter (OTC) products online, provided they adhere to the guidelines set by the Pharmaceutical Society of Ireland (PSI) and complete the necessary registration. This collaboration offers a significant opportunity for pharmacies to differentiate themselves and increase their online sales, especially benefiting those that have previously focused primarily on in-store transactions. By leveraging LUDA’s platform, pharmacies can expand their reach and provide a more convenient shopping experience

for customers, who can now purchase OTC medications online.

This move can help pharmacies capture a larger market share in the growing e-commerce sector and meet the increasing demand for online healthcare solutions.

As part of its international expansion, LUDA Partners has been actively participating in events in Ireland, demonstrating its value and fostering partnerships to help pharmacies thrive within their digital network. Recently, the LUDA Partners team was present at the Irish Pharmacy Awards ceremony to recognise the efforts of community pharmacy and to celebrate innovation within the sector.

Looking Ahead LUDA Partners' arrival in Ireland marks a significant milestone in the evolution of the pharmaceutical industry. The company offers tools and support to expand online sales channels. This initiative promises to transform the pharmacy sales experience, making it more convenient, accessible and efficient to meet customer demands. It also represents a crucial step towards a more integrated online vertical, which all pharmacies can benefit from while fortifying traditional pharmacy models with more options for innovative services and delivery options in Ireland.

For more information on how to be part of LUDA Partners’ digital network, visit their website on ludapartners.ie

PHARMACYNEWSIRELAND.COM

12

News

Get Checked in Pharmacy for ‘Silent Killer’ People are being urged to avoid the ‘silent killer’ of high blood pressure by getting checked.

Dr Angie Brown, consultant cardiologist and Medical Director with the Irish Heart Foundation, says high blood pressure is the biggest risk factor for stroke, as well as heart conditions, heart attacks and dementia.

Picture: Justin Farrelly

with the Irish Heart Foundation, said: “High blood pressure is the biggest risk factor for stroke, as well as heart conditions, heart attacks and dementia.

“A quarter of people having strokes are under the age of 65 so something like this can have devastating consequences not only for someone’s health, but also on their quality of life and financial independence if they are forced to stop working.

“Thousands of local pharmacies across Ireland offer free blood pressure checks, while most GPs will carry them out during general consultations.”

Prescribed medication is a key tool in managing hypertension, but lifestyle changes such as healthy eating, increasing physical activity, quitting smoking and limiting alcohol are also crucial.

The brief checks with pharmacies or GPs are a vital tool in detecting the condition, which can lead to heart attack, stroke, heart and kidney failure and dementia.

“What you don’t know could kill you as high blood pressure, in the vast majority of cases, has no symptoms,” warned Janis Morrissey, Director of Health Promotion with the Irish Heart Foundation.

The national charity is leading the ‘Before Damage is Done’ campaign this month to encourage adults, particularly those aged over 50, to get checked.

Official data shows that 9,652 lives were lost in Ireland due to heart disease and stroke in 2022.

Blood pressure is a measure of how effectively the heart pumps blood around the body – and a high reading, or hypertension, is manageable through medication and lifestyle changes.

A normal reading is about 120 over 80, with high blood pressure defined as 140 over 90 or higher.

“The vast majority of those diagnosed with hypertension have no warning symptoms, so it is vital that blood pressure is checked and kept in check,” said Ms Morrissey.

“It is quick, easy, pain free and does not involve a blood test.”

The campaign targets those who may be living with high blood pressure, the risk of which increases with age.

Everyone aged over 30 should get checked every five years and a GP can assess risk levels and may advise more frequent checks.

“There could be a history of hypertension in your family so a GP will look at cholesterol, weight and lifestyle factors to assess your cardiac health,” added Ms Morrissey.

Dr Angie Brown, Consultant Cardiologist and Medical Director

New Addition to Nutri Nua Range Introducing the newest addition to the Nutri Nua range, ‘Hair Skin and Nails’!

Containing a combination of Silica, Biotin, Zinc Picolinate, Copper Citrate, Vitamin C and Vitamin E to support healthy growth of hair and nails.

Each ingredient is carefully selected for the benefits it offers:  Silica derived from bamboo shoot, which consists of various compounds that provide antioxidant, skin-soothing and astringent properties. A higher silica content in the hair results in a lower rate of hair loss and increased brightness.  Biotin plays a role in keratin production, which is the protein that makes up your hair.  Zinc is vital for cell growth and collagen formation.  Vitamin C provides antioxidant protection while Vitamin E acts as an anti-inflammatory agent in the skin.

Nutri Nua is committed to selecting the most bioavailable forms of nutrients that contain no artificial additives or fillers, ensuring that consumers can be confident with each purchase of Nutri Nua, they are guaranteed a high quality, vegan supplement made in Ireland.

Available to order now from Wholefoods Wholesale.

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Dr David McConaghy, the Irish College of General Practitioners/ HSE Integrated Care Lead for Prevention said: “The ICGP supports this campaign to raise awareness about blood pressure and encourages people to attend their GP practice for a cardiovascular review.”

Sinead Mc Cool, Acting Head of Professional Services at the Irish Pharmacy Union, said the IPU is also backing the initiative.

The Irish Heart Foundation, in partnership with Medicare LifeSense, is encouraging blood pressure checks ‘Before Damage is Done’ in participating pharmacies in May and June.

HAIR, SKIN & NAILS

NEW

• Contains a combination of Silica, Biotin, Zinc Picolinate, Copper Citrate, Vitamin C and Vitamin E. • We also use silica derived from bamboo shoot, which contains various compounds that provide antioxidant, skin-soothing and astringent properties. Silica is included as a higher silica content in the hair results in a lower rate of hair loss and increased brightness.

• Biotin plays a role in keratin production, which is the protein that makes up your hair.

• Zinc is vital for cell growth and collagen formation.

• Vitamin C provides antioxidant protection while Vitamin E acts as an ant-inflammatory agent in the skin.

Available from Wholefoods Wholesale

14

News

Gaining an Extra Pharmacy Day Fox’s Life Pharmacy gain an extra day in the week thanks to new shelf labels As a small to medium sized business, what would you do to regain a day’s worth of time each week? That’s what Electronic Shelf Labels have done for one Offaly pharmacy.

Shane Carney, Fox's Life Pharmacy in Birr

electronic replacement for our paper price tags. We obviously wanted accurate pricing, more ease and flexibility with running promotions, something that is better for the environment and a sleeker look in-store. However, the foremost driver was to save time.

We are, thankfully, a very busy store. Now the staff here have much more time to spend helping our customers,” explained Shane.

The pharmacy chose DIGI because of their promise of rapid support, should they need it.

DIGI’s field engineers, remote support team and even spare parts, are all based here in Ireland; unlike with other providers of the Electronic Shelf Labels.

Fox’s Life Pharmacy report saving up to 10 labour hours a week since switching to the automated price labels on their shelves. The pharmacy, health and beauty store in Birr is run by pharmacist Shane Carney. In 2019, DIGI installed approximately 2,500 of the digital labels across the store to replace paper price stickers on their products and paper labels on their shelves. The e-paper shelf tags run on long-life batteries and are integrated with the store’s EPOS

via a secure radio-frequency connection. The product information, prices, promotions and even label designs, can be updated individually, all-at-once, automatically or manually. Stores can update the labels from a handheld device, their back office or updates can be rolled out centrally from head office – a game-changer in terms of efficiency.

“There were several driving factors behind our decision to seek an

“The start of the month is our busiest time for lots of reasons and on top of that, it’s when suppliers tend to change prices and promotions. This is now much easier to manage. We are very happy with the ease of use, the control, the time saving and the look of the system. We can see a return on investment and our staff have more time to do more valuable work in-store,” concluded Shane.

To find out more about this solution, call DIGI on: +353 1 295 4844 or visit: digi.ie.

Think Health, Think Pharmacy “Think Health, Think Pharmacy” is a new global campaign launched by the International Pharmaceutical Federation to raise awareness of pharmacies as places of primary health care provision and to advocate for pharmacists as healthcare professionals.

Despite substantial and recent advancements in pharmacy practice, too many people still perceive pharmacies as commercial enterprises rather than places of healthcare provision, which is an obstacle to pharmacists providing the services that they are trained to provide and that our health systems and communities desperately need, the federation says.

“Our profession proved its ability and dedication to the health of their communities during the COVID-19 pandemic and now is the time to make a bigger push for more professional recognition and the additional pharmacy services that go with that. This campaign is an important strategy to advocate for our members and the wider profession around the world,” FIP president Paul Sinclair said. FIP’s “Think Health, Think Pharmacy” campaign, supported by a statement from the FIP Bureau published today, will be a long-running campaign, sustained through regular releases of new campaign materials and other activities.

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World No Tobacco Day The World Health Organization (WHO) and STOP, a global tobacco industry watchdog, have launched “Hooking the next generation,” a report highlighting how the tobacco and nicotine industry designs products, implements marketing campaigns and works to shape policy environments to help them addict the world’s youth.

This comes just ahead of World No Tobacco Day marked on 31 May, where WHO is amplifying the voices of young people who are calling on governments to protect them from being targets of the tobacco and nicotine industry.

The report shows that globally an estimated 37 million children aged 13–15 years use tobacco, and in many countries, the rate of e-cigarette use among adolescents exceeds that of adults. In the WHO European Region, 20% of 15-yearolds surveyed reported using e-cigarettes in the past 30 days.

Despite significant progress in reducing tobacco use, the emergence of e-cigarettes and other new tobacco and nicotine products present a grave threat to youth and tobacco control. Studies demonstrate that e-cigarette use increases conventional cigarette use, particularly among non-smoking youth, by nearly three times.

"History is repeating, as the tobacco industry tries to sell the same nicotine to our children in different packaging,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “These industries are actively targeting schools, children and young people with new products that are essentially a candyflavoured trap. How can they talk about harm reduction when they are marketing these dangerous, highly-addictive products to children?”

These industries continue to market their products to young people with enticing flavours like candy and fruit.

WHO urges governments to protect young people from the uptake of tobacco, e-cigarettes and other nicotine products by banning or tightly regulating these products.

HELP YOUR PATIENTS QUIT FOR GOOD WITH COMBINATION NRT NOTHING IS MORE EFFECTIVE *1

NICE guidelines recommend combination NRT to quit smoking 1 Combination NRT can increase long term quit rates by 27% 2 compared with the use of a single NRT product Stop smoking aid. *compared to single NRT or other smoking cessation medications available OTC. 1. NICE guidelines [NG209]. Tobacco: preventing uptake, promoting quitting and treating dependence. November 2021.

2. Theodoulou A et al. Cochrane Database of Systematic Reviews 2023, Issue 6.

Art. No.: CD013308. DOI:10.1002/14651858.CD013308.pub2 Nicorette Icy White 2mg Medicated Chewing Gums, Nicorette Invisi 15mg/16 hours Patch. Nicorette 15mg Inhaler: For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit. Helping smokers temporarily abstain from smoking (Gum and Inhaler only). In smokers currently unable or not ready to stop smoking abruptly. Gum, Inhaler may also be used as part of a programme to reduce smoking prior to stopping completely. 2mg Gum or Inhaler may be used in combination with Invisi 10mg and 15mg Patch for the treatment of tobacco dependence as part of a stop smoking programme. Dosage: Smoking cessation: Gum: The gum should be used whenever there is an urge to smoke. Not more than 15 pieces of the chewing gum may be used each day. Nicorette Gum may be used for up to 3 months during which time the habits associated with smoking will be lost. If not successful after 12 weeks the patient should be encouraged to make a fresh attempt to stop smoking. Inhaler: Inhaler should be used whenever the urge to smoke is felt, up to a maximum usage of 6 cartridges per day. In the treatment of nicotine dependence, a course not exceeding three months is suggested, the patient stopping smoking completely at the start of the course. Patch: Heavy smokers: start at Step 1 with the 25 mg/ 16 hours patch and use one patch daily for 8 weeks. Gradual weaning from the patch should then be initiated. One 15 mg/16 hours patch should be used daily for 2 weeks followed by one 10 mg/16 hours patch daily for 2 weeks. Light smokers: start at Step 2 (15 mg) for 8 weeks and decrease the dose to Step 3 (10 mg) for the final 4 weeks.. Temporary Abstinence: During periods of temporary abstinence, the patient should use Gum or Inhaler when required to relieve nicotine cravings and withdrawal symptoms. Gradual cessation: For smokers who are unwilling or unable to quit abruptly. Use the gum/inhaler whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. The number of cartridges/gums is variable and depends on the patient’s needs. Not more than 15 pieces of the gum, 6 cartridges should be used per day. If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought. Reduced tobacco consumption should lead to complete cessation of smoking. A quit attempt should be made as soon as the number of cigarettes has been reduced to a level whereby the smoker feels ready to quit completely, then start as outlined for “smoking cessation” as given above. Combination therapy: Step 1: The 15mg Patch would be applied daily on waking for 16 hours and removed just before bedtime for a total of 8 weeks. The 2mg gum or Inhaler would be used ad libitum when the smoker felt an urge to smoke or in situations where he/she feels that breakthrough cravings may occur, up to a maximum of 15 pieces of gum per day or 6 cartridges per day. Step 2: After the initial 8 weeks the lower dose Invisi 10mg Patch should be used for a total of 4 weeks. The 2mg gum or Inhaler would be used ad libitum when the smoker felt an urge to smoke or in situations where he/ she feels that breakthrough cravings may occur, up to a maximum of 15 pieces of gum per day or 6 cartridges per day. Step 3: Use of the Invisi Patch should be stopped after the 12 week treatment program. The Nicorette 2 mg gum or Inhaler can continue to be used for a further 3 months during which time the habits associated with smoking will be lost.

Contraindications: Use in non-smokers, Use in persons hypersensitive to nicotine or any ingredient in the formulation. Special Warnings and Precautions: The benefits of quitting smoking outweigh any risks associated with correctly administered nicotine replacement therapy (NRT). A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions: - Cardiovascular disease: Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, recent cerebrovascular accident, and/or who suffer with uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicorette may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision. Allergic reactions: Susceptibility to angioedema and urticaria. Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects. Gastrointestinal Disease: Nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and NRT preparations should be used with caution in these conditions. Seizures: Use with caution in subjects taking anti-convulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine. Phaeochromocytoma and uncontrolled hyperthyroidism: Nicotine, both from NRT and smoking, causes the release of catecholamines from the adrenal medulla. Therefore, Nicorette should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma. - Diabetes Mellitus:. Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when smoking is stopped and NRT is initiated, as reductions in nicotine-induced catecholamine release can affect carbohydrate metabolism. Patients with diabetes mellitus may require lower doses of insulin as a result of smoking cessation. - Smokers who wear dentures may experience difficulties in chewing Nicorette Gum. The chewing gum may stick to, and may in rare cases damage dentures. Transferred dependence: Nicotine in any dose form is capable of inducing a dependence syndrome after chronic use and is highly toxic after acute use. However, dependence with Nicorette Gum is a rare side-effect and is both less harmful and easier to break than smoking dependence. Danger in children: Doses of nicotine tolerated by smokers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be handled or ingested by children. Nicorette Inhaler should be used with caution in smokers with chronic throat diseases and bronchospastic disease. Invisi Patch should be removed prior to undergoing any Magnetic Resonance Imaging (MRI) procedures to prevent the risk of burns. Undesirable Effects: Regardless of the means used, a variety of symptoms are known to be associated with quitting habitual tobacco use. These include emotional or cognitive effects such as dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating, and restlessness or impatience. There may also be physical effects such as decreased heart rate; increased appetite or weight gain, dizziness or presyncopal symptoms, cough, constipation, gingival bleeding or aphthous ulceration or nasopharyngitis. In addition, and of clinical significance, nicotine cravings may result in profound urges to smoke. Adverse Drug Reactions: Nicorette may cause dose dependent adverse reactions similar to those associated with nicotine administered by other means and are dose dependent. Most of the undesirable effects reported by the subjects occur during the early phase of treatment. Gum: Immune System Disorders: Hypersensitivity - Common Anaphylactic reaction - Not known. Psychiatric Disorders – Abnormal Dreams – Uncommon. Nervous System Disorders: Headache - Very Common, Burning sensation, Dysgeusia, Paraesthesia – Common, Seizure - Not known. Eye Disorders: Blurred Vision, Lacrimation increased – Common. Cardiac Disorders: Palpitations, Tachycardia - Not known. Vascular Disorders: Flushing, Hypertension – Uncommon. Respiratory, Thoracic and Mediastinal Disorders: Cough, Throat irritation - Very common. Bronchospasm, Dysphonia, Dyspnoea, Nasal Congestion, Sneezing, Throat tightness – Uncommon. Gastrointestinal Disorders: Hiccups, Nausea - Very common. Abdominal pain: Diarrhoea, Dry mouth, Dyspepsia, Flatulence, Salivary hypersecretion, Stomatitis, Vomiting – Common. Eructation Glossitis, Oral mucosal blistering and exfoliation, Paraesthesia oral – Uncommon. Dysphagia, Hypoaesthesia oral, Retching – Rare. Dry throat, Gastrointestinal discomfort Lip pain - Not known. Skin and Subcutaneous Tissue: Hyperhidrosis, Pruritus, Rash, Urticaria Disorders – Uncommon. Erythema - Not known. Musculoskeletal and Connective Tissue Disorders: Pain in jaw – Uncommon. Muscle tightness - Not known. General Disorders and Administration Site Conditions: Fatigue – Common. Asthenia, Chest discomfort and pain, Malaise – Uncommon. Allergic reactions including angioedema - Rare. Inhaler: Immune system disorders: Common – Hypersensitivity. Not known - Anaphylactic reaction. Psychiatric Disorders – Abnormal Dreams – Uncommon. Nervous system disorders Very common Headache Common Burning sensation Dysgeusia Paraesthesia, Seizure - Not known. Eye disorders Not known Blurred vision Lacrimation increased Cardiac disorders Uncommon Palpitations Tachycardia Vascular disorders Uncommon Flushing Hypertension Respiratory, thoracic and mediastinal disorders Very common Cough Throat irritation Bronchospasm Dysphonia Dyspnoea Nasal congestion Sneezing Throat tightness Gastrointestinal disorders Very common Hiccups Nausea Common Abdominal pain Diarrhoea Dry mouth Dyspepsia Flatulence Salivary hypersecretion Stomatitis Vomiting Uncommon Eructation Glossitis Oral mucosal blistering and exfoliation. Paraesthesia oral Rare Dysphagia Hypoaesthesia oral Retching Not known Dry throat Gastrointestinal discomfort Lip pain Skin and subcutaneous disorder Uncommon Hyperhidrosis Pruritus Rash Urticaria Not known Angioedema Erythema Muscoskeletal and connective tissue disorders Uncommon Pain in jaw Not known Muscle tightness . General disorders and administration site conditions Common Fatigue Uncommon Asthenia Chest discomfort and pain Malaise. Patch: Immune system disorder Uncommon Hypersensitivity Rare Anaphylactic reaction Nervous system disorder Common Headache Uncommon Paraesthesia. Not Known - Seizure. Cardiac disorders Uncommon Palpitations Tachycardia Vascular disorders Uncommon Flushing Hypertension Respiratory, Thoracic and Mediastinal Disorders Uncommon Dyspnoea Gastrointestinal disorders: Common Nausea Vomiting Rare Gastrointestinal discomfort and/or pain Skin and subcutaneous tissue disorders Very common Pruritus Common Rash Urticaria Uncommon Hyperhidrosis Rare Angioedema Erythema Musculoskeletal and Connective Tissue Disorders Uncommon Myalgia Rare Pain in extremity General disorders and administration site conditions: Uncommon Application site reactions Asthenia Chest discomfort and pain Malaise Fatigue. MA Holder: Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland. MA Number: Gum –PA 330/37/8. Patch – PA 330/37/6. Inhaler - PA 330/37/10. Date of Revision of the Text: July 2023. Legal Category: Products not subject to medical prescription. Supply through non-pharmacy outlets and pharmacies. Further information available upon request from Johnson & Johnson (Ireland) Ltd., Airton Road, Tallaght, Dublin 24, Ireland. Date of preparation: November 2023 IE-NI-2300146

16

News

United Drug Update Customer Support Team At United Drug Wholesale, our goal is to be your long-term partner for your business. We want to support you and help you grow and develop your business so you can provide the best possible patient care across your communities.

To help achieve this, we have decided to restructure our sales and support teams to better serve your needs and help provide a more tailored and personalised offering for you, our valued customers.

We are delighted to announce some new additions to our sales team as well as the new supports and benefits that you can enjoy as a customer of United Drug Wholesale.

Michael Taylor continues in his role as Head of Sales and Retail Solutions and has developed the commercial team structure to continue delivery of outstanding support to customers.

In her role, Orlagh leads a team of talented expert professionals, providing guidance, coaching, and mentorship to help achieve their full potential. The team will support the growth of procurement services (Pharmax) and claims management system (ARC) that have been developed by United Drug to support business owners.

She along with her team are passionate about building strong relationships with customers and helping them navigate their pharmacy challenges to achieve their goals. With a focus on customer satisfaction and long-term relationships, Orlagh is committed to delivering value to clients and exceeding their expectations.

Dedicated Team for Pharmacy Groups We have developed a dedicated team to look after the Pharmacy Groups, led by Sonya Lynch and supported by Liam Heavey. Both Sonya and Liam have extensive experience in the pharmaceutical sector which will enable them to support the larger Pharmacy groups and develop United Drug as a strategic partner with head office teams. The new structure provides dedicated support to the larger groups while offering value added services to ensure that group objectives are achieved. The new structure provides our customers with enhanced support by providing a single point of contact for the group. This aligned group approach ensures that support is consistent across the group.

Dedicated team for Independently Owned Businesses We will improve focus for independent businesses with a restructured experienced Support team. To deliver this we have added a new leadership role which is held by Orlagh Dunne.

Orlagh Dunne is a dedicated relationship and support manager for United Drug and their wholesale independent customers. Having over 7 years extensive experience in the pharmacy industry Orlagh has an abundance of knowledge to help support your business in both retail and wholesale.

PHARMACYNEWSIRELAND.COM

Map Within the Area Support team there are some familiar faces and names including Leonard Manley with over 35 years’ experience who will cover the Central region, Barry Scannell, 35 years’ experience responsible for the South Region and Orla Doyle 15 years’ experience covering the North region.

Dedicated support team for added value services and retail solutions.

We continue to enhance business offerings with our specialised teams. The Pharmax team of Adrian O’Sullivan, Reggie Ismailov and Jo Moloney support the

Pharmax buying group resource while Alan Franklin manages & maintains the ARC Claims system.

When speaking of the change in structure and account management Michael Taylor had the following to say “Thank you to all our valued customers for their continued support, we really appreciate it. We are excited about the future and look forward to building long term and meaningful relationships and making a difference to the Irish Pharmacy healthcare sector.”

We aim to keep your business thriving with support that is tailored to both your needs and those of your customers.

Dedicated team for Independently Owned Businesses We aim to keep your business thriving with support that is tailored to both your needs and those of your customers.

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20

Infant Feeding

How can pharmacists support mothers to establish breastfeeding in the community?

Denise is an experienced Midwifery clinician, educator and researcher. Denise and her colleagues in UCD between 5-40 minutes. Bothabreasts are offered.

Theexploring baby’s urine and School of Nursing, Midwifery and Health systems have recently completed national study thestooling pattern i appropriate to age.

The baby has a normal skin tone with no signs of jaundice. knowledge, attitudes and practices of GPs, GPNs and GP trainees in relation to breastfeeding. This research is in collaboration with the HSE. Written by Denise McGuinness, RGN RM RNT IBCLC FFNMRCSI between 5-40 minutes. Both breasts are offered. The baby’s urine and stooling pattern is MSc Research, Assistant Professor/ Lecturer in Midwifery at the School appropriate to age. and TheHealth baby has a normal skin tone with no signs of jaundice. of Nursing, Midwifery Systems, University College Dublin

Maternal benefits include the protective effect of breastfeeding against breast cancer (Stordal, 2022) and ovarian cancer, reducing the risk of type 2 diabetes, hypertension, cardiovascular disease (Nguyen et al. 2019., Rajaei et al 2019) and osteoporosis. Breastfeeding beyond the period of lactation contributes significantly to improved health outcomes for both mother and child (Victora et al. 2016).

This article presents an overview of the importance of breastfeeding for women, infants, children and their families; in addition to some practical supports and advice to assist the pharmacist support breastfeeding mothers in the early days and weeks following birth.

feeding and content following What isisthe What “aInternational good latch”Code for breastfeeding?

the feed. After initial rapid sucks the baby will take deep rhythmic sucks. Swallows may be less The International Code The of baby is heldaudible o CLOSEclose until a mother’s milk Marketing o of breastmilk substitutes HEAD FREEtilt back, chin leading comes, approximately Day 3-4 is a set of recommendations o IN-LINE- head and neck following (alignment) birth. The length of each NOSE- and opposite the nipple developed oto protect support feed will vary but generally baby breastfeeding which in turn will The cost of not breastfeeding will feed between 5-40 minutes.

The World Health Organisation stop inappropriate marketing of Both breasts are offered. The is high. The Lancet series (WHO) recommends that all breastmilk substitutes. The code baby’s urine and stooling pattern on breastfeeding advised infants are exclusively breasted is appropriate to age. The baby that >800,000 child deaths covers commercial infant formula for the first six months of life and has a normal skin tone with no globally were attributed to not milks, bottles and teats. The aim breastfeeding is continued with signs of jaundice. breastfeeding according to the of the code is to provide safe the introduction of complementary WHO recommendations (Victora et nutrition for infants and young foods until two years or beyond What is “a good latch” for al. 2016). children. Further information (WHO, 2023). breastfeeding? is available here: https://assets.

The knowledge, attitudes hse.ie/media/documents/ncr/ The key principles are as followsBreastfeeding rates are low and practices in relation to in Ireland in comparison to policy-breastmilk-substitutesbreastfeeding and lactation of the o CLOSE - The baby is held close International standards. The HSE/ The key principles are as follows-marketing.pdf GP, Public Health Nurse, Dietitian HPO (2024) Perinatal Statistics o HEAD FREE - tilt back, chin and Pharmacist can greatly What are the signs that a Report describes some fluctuations o support CLOSEis held close leading enhance the offeredThe babynewborn infant is feeding well? to breastfeeding rates according obreastfeeding HEAD FREEpresently to families tilt back, chin leading o IN-LINE - head and neck to county in Ireland. Higher The baby(alignment) will feed 8-12 times in the community (Walsh et al.head and o IN-LINEneck (alignment) breastfeeding rates are reported in a 24 hour period. Babies are 2023; Brown 2016; Doherty Picture credit @JoJofordIllustrations in Cork, Kerry and Kilkenny, while o NOSEopposite the nipple et al. 2020). generally calm and relaxed while o NOSE - opposite the nipple lower breastfeeding rates <35% are reported in Louth. Maternal age influences breastfeeding choice with higher breastfeeding rates 3 noted among mothers in the 35-39 year age group. of Marketing of Breastmilk substitutes?

The key principles are as follows-

What is “a good latch” for breastfeeding?

Research has identified the importance of breastfeeding and the risks of not breastfeeding.

Infant benefits include less overweight and obesity, less asthma and allergy (Azad et al.

2020), reduced incidence of type 2 diabetes (Horta et al.2015) and improved cognition/IQ (McGowan and Bland, 2023). Exclusive breastfeeding for 90+ days is associated with reduced childhood morbidity (Murphy et al. 2023).

PHARMACYNEWSIRELAND.COM Picture credit @JoJofordIllustrations

Picture credit @JoJofordIllustrations

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What is the difference between full breasts and engorged breasts?

22

It is normal for breastfeeding mothers to feel a degree of fullness between days 3-5 following Infant Feeding birth, as a full milk supply is established. The breastfeeding mother should continue to feed

the baby responsively, 8-12 timesbreasts? during a 24 hour period.

What is the difference between full breasts and engorged

is the difference betweenmothers ItWhat is normal for breastfeeding to feel a degree of fullness between days 3-5 following Full Breasts Engorged Breasts full breasts and engorged birth, as a full milk supply is established.

The breastfeeding mother continue to Breasts feed Breasts are warm, firm, tendershould and heavy are hot, hard, painful and shiny in breasts? the baby responsively, 8-12 times during a 24 hour period. appearance

It is normal for breastfeeding The milk flows easily The milk does not flow easily mothers to feel a degree of fullness Full Breasts Engorged Breasts between days 3-5 following birth, The mother will not have a high temperature Breasts arebreasts warm,isfirm, tender and heavybreasts?

Breasts are hot, hard, painful and shinyThe in mother may have a raised temperature e between full and engorged as a full milk supply established.

The baby may have difficulty latching to the The breastfeeding mother appearance should continue to feed the baby breast ng mothers feelflows a degree 3-5milk following The to milk easilyof fullness between days The does not flow easily responsively, 8-12 times during a Anti-inflammatory pain relief may be is established.

The breastfeeding mother should continue to feed The mother will not have a high temperature The mother may have a raised temperature 24 hour period.

The baby may have difficulty latching indicated to the breast • Avoid How to teach Anti-inflammatory a mother hand Apply cold compresses to the Breasts Engorged pain reliefaggressive may be massage of the breast as this may worsen expression breast. Hand express to release indicated nder and heavy are hot, hard, painful and shiny in Treatment for engorgement symptoms. milk.

A techniqueBreasts called reverse

2 times Treatment during a 24 hour period. for engorgement

• Apply cold compresses or ice packs to the breasts

Hand washing before starting.

• Do not stimulate the breasts. appearance pressure softening is also • Anti-inflammatory medication/ supportive. Reverse pressure mother out the to the breast.

• Analgesia and anti-inflammatory The milk does notThe flow easily painHand relief as indicated.

Apply coldcarries compresses express to release milk.

A technique called softening allows the mother to following technique. medication as indicated. for engorgement a high Treatment temperature The mother may have a raised temperature move excess fluid away from If symptoms have not subsided in pressure Reverse pressure softening allowsa small the mother •reverse Gentle massage ofsoftening bothtobreasts the areola and enable baby • Hand express amount to of The the baby may have difficulty latching theis also24supportive. hours, or symptoms deteriorate to latch.cold Herecompresses is information on milk for comfort, if the breasts Apply to the breast.

Hand express to release milk.

A technique called rapidly, advise the mother to seek • Place the thumb on the edge move excess fluid away from thea areola and enable the baby to latch.

Here is information on reverse pressure breast softening that the are very painful. medical review. Antibiotics will be of the areola at the 12 O’ Clock mother can work Anti-inflammatory with. reverse pressure softening is also supportive.

Reverse pressure softening allows the mother to pain relief may be indicated.

A mother with infective position. reverse pressure softening that the mother can work with.

• Do not use a breast pump. mastitis will experience flu like indicated Reverse pressure softening move excess fluid away from the areola and the3rd baby to latch. Here is information on • Place theenable 2nd and fingers symptoms, a high temperature • Medication is available on technique opposite at the 6 O’ Clock of 38.3C and will feel generally prescription to suppress Reverse pressure softening technique reverse pressure softening that the mother can work with. position. https://www2.hse.ie/babiesefrost frozen milk by leaving it to stand in the fridge or by standing the unwell. lactation. children/breastfeeding/tipsent Theofhand a C Shape. ontainertechniques/reverse-pressurein a jug of warm water. Keep the•https://www2.hse.ie/babies-children/breastfeeding/tips-techniques/reverse-pressurelid the forms container out of the Further information is available • If a bereaved mother was Reverse pressure softening technique Compress and release and here-https://www2.hse.ie/ ater. Once the milk is defrosted, use it straight away.

Don’t re-freeze softening/#:~:text=Reverse%20pressure%20softening%20moves%20mild,for%20your%20baby%20 softening/#:~:text=Reverse%20 expressing milk regularly with repeat the process. conditions/mastitis/ pressure%20softening%20 an electric breast pump, for https://www2.hse.ie/babies-children/breastfeeding/tips-techniques/reverse-pressureilk once it’sHand thawed.

Maketosure you milk. use to%20attach. the stored milk first. he breast. express release A oldest technique called moves%20mild,for%20your%20 • The position of the fingers can example, a sick or premature What additional HSE, private softening/#:~:text=Reverse%20pressure%20softening%20moves%20mild,for%20your%20baby%20 baby%20to%20attach. be rotated around breast.to infant, it will be important to and community volunteer is also to%20attach. supportive.

Reverse pressure softening allows thethe mother advise the mother to reduce her breastfeeding supports are • Move to the 2nd breast, gentle milk supply slowly. The mother available in the community? om the areola and enable the baby to latch.

Here is information on massage, compress and release. can reduce the duration of https://www2.hse.ie/babiespumping and number of times to Here is further information from the that the mother can work with. ou can give your baby your milk straight HSE fromhttps://www.youtube.com/ the fridge or warm it children/breastfeeding/ pump in a 24hr period, gradually o room temperature. Warm defrosted milkwatch?v=bnIY2BqshCE by placing the container in over a few days.

The Public Health Nurse ng technique kewarm water.

Never heat it in the microwave as this can destroy the o stand in the fridge or by standing the Babies are most effective at I’m interested in breastfeeding. Is La Leche league draining theyour breast by direct there a university breastfeeding utrients and cause hot spots which burn baby’s mouth.

Keep the lidcan of the container out of the can -children/breastfeeding/tips-techniques/reverse-pressureCuidiu breastfeeding. course that pharmacists can , use it straight away. Don’t re-freeze %20pressure%20softening%20moves%20mild,for%20your%20baby%20 participate in?

Friends of Breastfeeding What is mastitis and what advice

Defrosting frozen breastmilk

Warming your milk breastmilk

you use the oldest stored milk first. can I offer to a breastfeeding How to express by hand HSE (2022) mother with symptoms of HSE (2022)

kWash your hands carefully.

To helpfrom yourthe milkfridge flow,or you can:it straight warm osted milk by placing the container in sit comfortably • microwave he as this can destroy the relax think about your s •which canand burn your baby’s mouth. baby. Looking at photos or videos of them and listening A toHSE relaxing (2022)music can help

y hand •

mastitis?

Mastitis is an inflammation of the breast. It can occur in one or both breasts. Conservative measures used initially are-

International Board Certified Lactation Consultant (IBCLC) Suppression of lactation following infant loss

• Continue to breastfeed as normal.

The following information will support a bereaved mother following infant loss i.e. stillbirth, if the mother wishes to suppress lactation. Some mothers may 4 choose to continue expressing breastmilk and donate their breastmilk to a human milk bank.

• Apply ice/cold compresses.

A

• Wear a support bra.

• Ensure correct position and attachment at the breast, with effective feeding.

4

Yes. The UCD Professional Certificate in Breastfeeding and Lactation is open to all healthcare professionals registered with a professional body. The next six month course commences in January 2025. It is a blended learning programme. Further information available here: https://hub.ucd.ie/usis/!W_ HU_MENU.P_PUBLISH?p_ tag=PROG&MAJR=X946 23

References and further reading available upon request

have someone massage 4. your Place your thumb on the edge of your back and shoulders, and areola. This is where the darker part

gently warm your breast. Aof your nipple joins the lighter skin of good way to do this is to put your breast. Place your second and a warm facecloth over your third finger on the opposite edge of breast. your areola. As you can see, your hand forms the shape of the letter C. 4 r Massage your breasts. Look B at ngpictures A and B to see how to To see how to do this, look at picture do this.AGently roll your nippleC. If yourBareola is small, place the thumb B and finger a couple of between your fingers. our (HSE, 2022) centimeters past or beyond the areola.

• n:

A put ur

5. You then compress and release the breast tissue using rhythmic PHARMACYNEWSIRELAND.COM movements. Compress and release and, as you can see, a little drop of

C C

Colostrum

C

NOW AVAILABLE

Stelara One-Press ®

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

Same Stelara … now even simpler1 ®

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

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

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

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

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

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

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

CP-416115 | Date of Preparation: October 2023

24

Epilepsy

Epilepsy Ireland – making communities Epilepsy aware!

May 20th – May 26th marked National Epilepsy Week, bringing one of the most common neurological conditions in the country into focus. With this important week for the epilepsy community having just taken place, we invited Epilepsy Ireland – via their Advocacy & Communications Manager, Paddy McGeoghegan - to share more information with Irish Pharmacy News about the work of the organisation….

Written by Paddy McGeoghegan, Advocacy & Communications Manager, Epilepsy Ireland

awareness and advocacy campaigns; and finally, our investment in epilepsy research.

It a pleasure to be writing in this edition of Irish Pharmacy News to give community pharmacists insight about our work on the behalf of people with epilepsy and their families.

Epilepsy Ireland’s vision is to achieve a society where no person’s life is limited by epilepsy.

Our Head Office is in Dublin, but like community pharmacists, we are also based in communities across Ireland – with 9 regional offices from Donegal to Cork.

This strong community presence and work within communities is so important because epilepsy is a condition that affects people in all walks of life across Ireland.

In fact, we estimate that over 45,000 people live with epilepsy in Ireland – making it one of the most common neurological conditions in the country.

Working towards our overall vision involves various strands of work.

This includes our support and information services for people with epilepsy and their families; our training and education programmes for the wider community; our

Our support and information services are much depended upon by people with epilepsy and their families. This service is delivered by our local Community Resource Officers via our regional offices, and experiences circa 20,000 contacts every year. Epilepsy is a very individual journey for those living with it and the families that support them. Our services aim to support people along every step of that journey through one-toone work via the Living Well with Epilepsy ‘Toolkit’ programme, and groups events like our local/ national supports groups in addition to groups targeted at different age cohorts for e.g. Teen Time – an online group for teens to meet others living with epilepsy and discuss challenges they may be facing.

The best example of our Training and Education programmes can be seen via our Epilepsy Awareness and Administration of Buccal Midazolam (BM) training for professionals. I know many of you reading will be familiar with BM and its importance in reducing hospitalisation and reducing risk from prolonged seizures.

Every year, we train circa 3,000 professionals in the administration of BM – with the vast majority of those being teachers/SNAs supporting a child with epilepsy in the classroom.

Some of the Epilepsy Ireland Community Resource Officer team

PHARMACYNEWSIRELAND.COM

Awareness is so important when it comes to epilepsy. Unfortunately, as mentioned, there can still be stigma and misconceptions associated with the condition.

The best way to combat this is by encouraging ongoing education and in particular, encouraging people with epilepsy to speak more openly about their condition to help the public separate the myths from the facts. During National Epilepsy Week, we provided a platform and shared several personal stories of the lived experience of epilepsy; these are the most powerful tools available to us when it comes to educating the public.

Achieving positive policy changes to improve the lives of people with epilepsy is also a key area of our work. As I write this, we have just assisted Minister Heather Humphreys with the launch of a new Free Travel scheme for those medically unfit to drive for at least a year and those who have never held a license due to a long-term health condition or disability. For many years, we advocated for this scheme and are delighted to see it officially launched – with an estimated 32,000 people set to potentially benefit. With elections on the horizon, we hope to

achieve many more positive policy changes for people with epilepsy in the future.

Research can mean many things to many people, but to our community, it represents hope.

Learning more about a condition which still has many unknowns can help to change the outlook for people diagnosed with epilepsy in the future. We first began investing in research in 2009, and last year, we reached the milestone of having invested a total of ¤1.5 million in Irish epilepsy research across 23 different projects.

While this has been a brief overview, I hope I have provided you with some insight into the work we do. As community pharmacists, you will engage with people with epilepsy every day – so please do encourage the people with epilepsy you meet to reach out to us for information and support.

Likewise, we are also there for local communities on all thing’s epilepsy-related so if you need information, please do not hesitate to contact us on info@epilepsy.ie or by calling 014557500.

For more information on epilepsy and Epilepsy Ireland, visit www.epilepsy.ie

Hayfever

55 micrograms/dose Nasal Spray Suspension triamcinolone acetonide

For the treatment of the nasal symptoms of seasonal allergic rhinitis Nasal Congestion Sneezing and Itching Stuffy or Runny Nose

For Adult use only. Not for use in children under 18 years. A copy of the summary of product characteristics is available upon request or alternatively please go to www.clonmelhealthcare.ie. Product not subject to medical prescription. Supply through pharmacies only. PA23180/001/002. PA Holder: Opella Healthcare France SAS, 157 avenue Charles de Gaulle, 92200 Neuilly-sur-Seine, France. Distributed by: Clonmel Healthcare Ltd., Clonmel, Co.Tipperary. Date Prepared: February 2024 2024/ADV/NAS/063H

26

News

New Research shows OTC Buying Choices 83% of Irish consumers signal price as key consideration when purchasing over-the-counter medicines.

One in two consumers (49%) say that the price of over-the-counter medicines has increased in the past 12-months. issue securing a GP appointment.

A further 32% of those who could not secure a GP appointment, sought the advice of their pharmacist instead.

Commenting on the findings in its research, Sandra Gannon, Chief Executive, Azure Pharmaceuticals said, “There are three big insights from this research—price, trust, and the lack of importance that consumers attribute to the brand name relative to price or pharmacy recommendations.

“While we always knew that price matters, how much it matters and to whom are particularly apparent from this research. Inflation has risen steadily for the past two years, and generic medicines have seen an 11% price increase over this period.

 Pharmacy’s recommendation is the key influence for consumers decision-making  Nearly 1 in 2 (48%) have faced an issue in securing a GP appointment  32% of people who could not secure a GP appointment sought the advice of their pharmacist instead  Sandra Gannon, Azure Chief Executive: “Price matters—how much and to whom are particularly apparent from this research. Inflation has risen steadily for the past two years, and generic medicines have seen an 11% price increase over this period.”

The price of everyday, overthe-counter (OTC) medicines is ranked as either ‘very important’ (48%) or ‘important’ (35%) by 83% of participants in a new nationwide poll of over 1,000 consumers published by Azure Pharmaceuticals.

“On trust, the influential role of pharmacies in patient decisionmaking is clear, as is the importance of sustaining that trust.

Patients are savvy and when it comes to OTC medicines, they rate the fundamentals of healthcare expertise and reduced price above all else. That brand ranks as low as it does on their decision-making matrix is notable.

When asked about the price they pay for OTC medicines, one in two consumers (49%) said the amount they pay has increased in the past 12-months. Consumer Price Index data from the Central Statistics Office in February 2024 showed a cumulative 11% increase in OTC medicines versus the previous two years.

Across a range of questions, the research—conducted by Ireland Thinks on behalf of Azure Pharmaceuticals—found that people aged 35 to 54 are particularly concerned with price.

When asked to rank what factors influenced their OTC purchasing decisions, only 8% cited brand as a primary factor. The recommendation of the pharmacist (53%) ranked highest, followed by price (33%). On this issue, there was a divergence in attitudes between men and women. Men (58%) ranked the recommendation of the pharmacist as more important than women (48%), while women (38%) ranked price more highly than men (29%).

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On the issue of generic and branded OTC medicines, the influential role of the pharmacy was again evident with 55% saying a pharmacy recommendation in favour of a generic alternative would have a significant impact on their decision.

The research was published to coincide with Azure’s launch of a new range of cost-effective OTC medicines to be rolled-out over the coming 12-months. The first in the range, available in pharmacies, is Fexofenadine, an antihistamine medicine that helps with the symptoms of allergies such as sneezing, itchiness, running or blocked nose, or red and watery eye.

Azure said that the decision to name the product “Fexofenadine” after the actual active ingredient in the tablet reflects its view that users are “savvy enough to rate medical value over brand name”.

GP shortages are becoming a greater issue with patients waiting weeks to see a GP. 48% of people polled said they had faced an

“Against this backdrop, our new range of OTC medicines has real relevance. We want to empower consumers to make informed choices when it comes to medicines, reassured that they are getting the best value for a product that their pharmacist believes in.

Fexofenadine is the first of these with further products to following in the months ahead”.

Ms Gannon said that the findings published today are the first of a range of research topics it will be publishing over the coming months. It has also undertaken research on a range of other issues such as medicine shortages, difficulties securing a GP appointment, and the rising use of unlicensed medicines.

A copy of the Summary of Product Characteristics is available upon request. Product not subject to medical prescription.

Supply through pharmacies only. PA22871/004/002, License Holder, Azure Pharmaceuticals Ltd, 12 Hamilton Drive, The Rock Road, Blackrock, Co Louth. DPO: 12/4/24. * Ireland Thinks survey on behalf of Azure.

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83%

83% of Irish consumers signal price as key consideration when purchasing medicines.

A copy of the Summary of Product Characteristics is available upon request. Product not subject to medical prescription.

Supply through pharmacies only. PA22871/004/002, License Holder, Azure Pharmaceuticals Ltd, 12 Hamilton Drive, The Rock Road, Blackrock, Co Louth. DOP: 12/04/24. * Ireland Thinks survey on behalf of Azure.

www.azure-pharma.com

28

News

Celebrating a Ground-Breaking Milestone with New Initiative The Migraine Association of Ireland (MAI) is thrilled to announce the launch of a transformative initiative dedicated to enhancing the lives of those affected by migraine. This launch is a pivotal moment in our commitment to advance migraine support, education, and awareness across Ireland.

Pascal Derrien, CEO, Migraine Ireland

For three decades, MAI has stood as a beacon of hope and support for over 700,000 individuals navigating the complexities of migraine - a condition recognised by the World Health Organisation as one of the most disabling illnesses globally. As we celebrate our 30th anniversary, we are proud to unveil a series of innovative programs designed to empower both patients and healthcare professionals with the tools needed for effective migraine management.

This initiative will introduce new educational workshops, robust public awareness campaigns, and enhanced advocacy efforts aimed

at debunking myths and expanding understanding of migraine as a serious neurological condition.

Our CEO, Pascal, explains, "Our goal is to illuminate the profound impact migraines have on health, society, and the economy, and to foster a more informed and supportive community."

Migraine affects approximately 12-15% of the population, with a notably higher prevalence among women due to hormonal influences. The economic toll is substantial, with migraine costing Irish businesses an estimated ¤252 million annually due to lost productivity. Despite these challenges, migraine remains largely misunderstood and undermanaged.

Our new initiatives are tailored to address these issues directly.

They include: Digital Headache Diary: An innovative tool for children and young people to track and

manage their migraine symptoms effectively.

Comprehensive Resource Distribution: For healthcare professionals to enhance their understanding and treatment approaches.

Community Engagement Events: To foster connections and support among those affected.

We invite everyone - from patients and families to healthcare providers and stakeholders - to join us in this exciting journey.

Together, we can forge a path toward a future where migraine no longer dictates the terms of one's life.

For more information about the Migraine Association of Ireland and to get involved, please visit our website at www.migraine. ie. Together, we can make a difference in the lives of those affected by migraine.

Pharmacy Success Ltd. was set up to provide independent Pharmacy owners and Pharmacy Groups, with the advice and knowledge to improve the efficiency of their operations, increase revenue and maximise profitability.

With more than 20 years experience in a range of roles across the industry, I am highly motivated to help clients achieve strategic and organisational goals while consistently producing high quality output.

Core service Offerings HSE Claim Recovery and Process Improvement Margin Maximisation Improving Operational Efficiency Brian Battles – Director Tel: 086 080 9879 Email: brian@pharmacysuccess.ie

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Staff Training

120 mg Film-coated tablets Fexofenadine hydrochloride

Indicated for adults and children 12 years and older for the relief of symptoms associated with allergic rhinitis.

A copy of the summary of product characteristics is available upon request or alternatively please go to www.clonmelhealthcare.ie. Product not subject to medical prescription. Supply through pharmacies only. PA23180/014/001.

PA Holder: Opella Healthcare France SAS, 157 avenue Charles de Gaulle, 92200 Neuilly-sur-Seine, France.

Distributed by: Clonmel Healthcare Ltd., Clonmel, Co.Tipperary Date Prepared: February 2024 2024/ADV/TEL/032H

30

Conference

National Stroke Conference calls for more support for Patient Services A major National Conference on Stroke, hosted by the South Tipperary Stroke Communication Group, took place at the Cashel Palace Hotel, Cashel, Co. Tipperary, on Monday May 20th. The Conference, which attracted around 200 people, heard from professionals and stroke survivors and included demonstrations on developments in the area of innovations for persons with spinal cord injury, stroke, multiple sclerosis and other neurological conditions. At the outset, Cathaoirleach of the Municipal District, Cllr. Declan Burgess, welcomed all the delegates and the speakers to the 'City of the Kings'. Delegates had travelled from as far away as Coleraine in Northern Ireland, from Dublin, Mayo, Carlow and from several other parts of the country.

Martin Quinn opens the National Conference on Stroke at the Cashel Palace Hotel

As one of the organisers and a stroke survivor, I had the great pleasure of opening the Conference. Speaking at the Conference I said that it was an opportunity for experts, practitioners, researchers, and advocates from across the nation, to discuss the pressing health challenge of stroke. "Stroke, with its profound impact on individuals, families, and communities, demands our collective attention and concerted efforts. This conference serves as a platform for sharing knowledge, fostering collaboration, and advancing innovative solutions in stroke prevention, treatment, and rehabilitation. At this Conference we will engage in enlightening discussions, explore research driven initiatives, and exchange invaluable insights that will shape the future landscape of stroke

Professor Joe Harbison addresses the National Conference on Stroke at the Cashel Palace

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Chris Macey of the Irish Heart Foundation speaking to delegates at the National Conference on Stroke at the Cashel Palace Hotel

31 Ronan Langan of the DCU Exoskeleton Programme speaking at the National Stroke Conference at the Cashel Palace Hotel

"Stroke, with its profound impact on individuals, families, and communities, demands our collective attention and concerted efforts. This conference serves as a platform for sharing knowledge, fostering collaboration, and advancing innovative solutions in stroke prevention, treatment, and rehabilitation” care in our country. Today is an opportunity to discuss awareness, access to quality care, the needs of patients and carers, and how

we can make meaningful strides towards reducing the burden of stroke on our society" were my opening remarks.

One of the keynote speakers was Professor Joe Harbison, Associate Professor and Head of Discipline of Medical Gerontology in Trinity College Dublin & Stroke Physician in St James’s Hospital in Dublin and Clinical Lead of the Irish National Audit of Stroke.

Professor Harbison gave a very insightful presentation on data from hospitals around the country in relation to stroke, and he highlighted some of the key messages from the Irish National Audit of Stroke. The Professor also gave a presentation on Atrial Fibrillation and he took questions from the floor on several different aspects of stroke.

Chris Macey, Director of Advocacy and Patient Support at the Irish Heart Foundation, was another speaker at the Conference and he highlighted the current funding challenges facing the Irish Heart Foundation. "The Irish Heart Foundation is running a national support service for the biggest patient group in the country. Out of a total cost of ¤1.24 million a year to operate the service, it is receiving just ¤130,000 a year in statutory funding. This represents funding averaging less than ¤19 a head to deliver a pathway of professional support to people currently in the service, with often complex support needs. Any patients here today who have benefited from these services, know what the impact of losing them would be to individual lives, and on a wider scale across the country. The Irish Heart Foundation has been making up the shortfall by running down its reserves, and we are extremely concerned that we cannot guarantee the continuation of all of our services beyond the end of 2024. This is very worrying and must be addressed by the Government as a matter of urgency" said Chris.

Ronan Langan, Clinical Lead of the DCU Exoskeleton Programme, delivered a hugely interesting presentation, which included a

Young mother and stroke survivor, Heidi Kingston, speaking at the National Conference on Stroke at the Cashel Palace

demonstration of the Exoskeleton.

The Exoskeleton programme is physiotherapist led service allowing persons with reduced mobility due to paralysis, access to the ekso bionics exoskeleton, Ekso GT to allow them to complete sessions of supported walking facilitated by a trained handler. The programme is designed to deliver an array of benefits that regular walking in an exoskeleton provides for persons with spinal cord injury, stroke, multiple sclerosis and other neurological conditions.

Other speakers at the Conference included young stroke survivors Heidi Kingston and Darren Creaven. Young mother Heidi, gave an emotional testimony of suffering a stroke in December 2021. "I was an active and adventurous 32 year-old. I convinced myself that I was having a headache, a hormonal headache or maybe a side-effect of medication I took for the headache. Along with the headache I had numbness and tingling from my right side, from my neck all the way to my foot, and I had darkened peripheral vision. I was visiting family in New Jersey with my husband from our home in Galway, and only went to hospital following a phone call with my GP. It was there that he and I learned I had had a stroke.

I was in complete shock" said Heidi. Actor Darren Creaven from Galway explained that he suffered a stroke almost 7 years ago when he was visiting family in Clonmel, Co. Tipperary. "I suffered a bleed in my brain which caused me to lose all movement on my left side.

I was taken to Tipperary University Hospital and later transferred to Cork University Hospital before going to Galway University Hospital and finally to the National Rehabilitation Hospital for rehab.

Though I still have some deficits I have made a great recovery and am back acting once again" said Darren.

There was a lively and engaging question and answer session during the Conference and there was also a musical treat for attendees with performances from Aoife O'Farrell of the Rockwell Music Academy.

Tea/Coffee and some treats were served by the wonderful staff at the Cashel Palace Hotel with one attendee remarking that they were "treated like Royalty".

The Conference was supported financially by TASK Community Care and Home Instead Ireland and financial and technical support was provided by the Tipperary Volunteer Centre. In excess of 20 stands were in attendance with a wide range of information available.

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32

Acne

Acne: Current Treatment Options Acne is a common skin condition caused by various factors, including excess oil production, clogged pores, bacteria, hormonal fluctuations, and inflammation. Effective treatment often involves a combination of topical and oral medications tailored to acne's severity and underlying causes.

Written by Dr Patrick Treacy Owner and founder of the Ailesbury Clinics in Dublin and Cork

Topical Treatments

Oral Medications

Benzoyl Peroxide (BPO): This topical agent reduces bacteria and unclogs pores. It's often used as a first-line treatment for mild to moderate acne. However, it may cause dryness and irritation.

Recently, Benzoyl peroxide has been subject to scrutiny regarding its potential association with cancer risk. While regulatory agencies like the FDA generally recognize benzoyl peroxide as safe and effective for acne treatment, recent concerns have surfaced regarding the formation of benzene, a known carcinogen, under certain conditions. In a nutshell, the research suggests that benzene, a substance known to cause cancer, can form as a byproduct when benzoyl peroxide interacts with other ingredients or environmental factors such as heat and light.

Benzene is a concerning compound due to its carcinogenic properties and potential health risks.

Oral Antibiotics: Tetracyclines (e.g., doxycycline, minocycline) are often prescribed for moderate to severe acne to reduce inflammation and control bacterial growth. Longterm use may lead to antibiotic resistance. The dose of Doxycycline is usually 100mgs daily.

Retinoids: These derivatives of vitamin A help prevent hair follicles from becoming plugged, promote cell turnover, and reduce inflammation. Common retinoids include tretinoin, adapalene, and tazarotene.

Topical Antibiotics: Antibiotics like clindamycin and erythromycin are used to kill acne-causing bacteria on the skin's surface. They are typically used in combination with other acne treatments to prevent bacterial resistance.

Steroids: In severe cases, corticosteroid injections can quickly reduce inflammation and promote the healing of large, painful acne lesions.

Oral Contraceptives: For women with hormonal acne, oral contraceptives containing oestrogen and progestin can help regulate hormone levels and reduce acne flare-ups. Dianette contains two active ingredients: ethinylestradiol (an oestrogen) and cyproterone acetate (an antiandrogen). Cyproterone acetate works by blocking the effects of androgens, thereby reducing sebum production and preventing acne breakouts. By inhibiting the action of androgens, Dianette helps regulate hormonal fluctuations associated with acne, particularly in conditions such as polycystic ovary syndrome (PCOS), where excess androgens contribute to acne formation. Excessive sebum production is a key factor in the development of acne. Dianette helps decrease sebum production, leading to clearer skin and reduced acne lesions.

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Spironolactone: This medication, originally used as a diuretic, can effectively treat hormonal acne by blocking androgens (male hormones), contributing to oil production. It's commonly prescribed for women with hormonal imbalances. The typical starting dose of spironolactone for acne treatment is usually 25 to 50 milligrams (mg) per day, taken orally. However, the dosage may vary depending on factors such as the severity of the acne, the individual's medical history, and their response to the medication.

In some cases, healthcare providers may gradually increase the dosage to 100 to 200 mg per day if the initial dose is ineffective in managing acne symptoms.

Isotretinoin (Roaccutane): Reserved for severe, persistent acne that has not responded to other treatments, isotretinoin is a potent oral medication derived from vitamin A. It works by shrinking the sebaceous glands, reducing oil production, and preventing acne recurrence.

However, it carries significant potential side effects. It requires careful monitoring, including regular blood tests to check liver function, lipid levels, and pregnancy tests for females due to its teratogenic effects.

Regular monitoring of blood tests, including sex hormone levels (testosterone), liver function tests, and lipid profiles, is crucial during isotretinoin treatment to manage potential side effects and ensure patient safety. Additionally, healthcare providers must determine appropriate medication doses and treatment durations based on individual patient factors, severity of acne, and response to therapy. The dosage of Roaccutane (isotretinoin) for acne treatment varies depending on factors such as the severity of the acne, the individual's weight, and their response to the medication. However, a typical starting dose for Roaccutane is typically around 0.5 to 1 milligram per kilogram of body weight per day, taken orally in divided doses.

For example, a person weighing 70 kilograms might start with a

daily dose of 35 to 70 milligrams.

This dosage may be adjusted over time based on the individual's response to the medication and any side effects experienced.

Treatment with Roaccutane usually lasts 16 to 20 weeks, although it may be shorter or longer depending on the individual's needs and response to treatment.

It is important for individuals to take Roaccutane exactly as prescribed by their healthcare provider and to follow up regularly during treatment to monitor progress and manage any potential side effects.

Since Roaccutane can cause serious side effects and is associated with risks such as congenital disabilities if taken during pregnancy, it is only available by prescription and should be used under the supervision of a qualified healthcare professional.

Laser Treatments for Acne: Cutera AviClear In acne treatment, laser technology has emerged as an innovative approach to combat this condition.

One laser treatment is the Cutera AviClear, which has gained recognition for its efficacy in targeting acne at its source. The Cutera AviClear is an FDA-cleared energy device that addresses mild to severe acne concerns.

It operates at a wavelength of 1726 nm, which is optimized to penetrate deep into the skin and target the root causes of acne. The AviClear laser precisely targets acne lesions, delivering energy to the affected areas without causing damage to surrounding skin tissue. By effectively reducing skin sebum, AviClear helps prevent the formation of acne lesions, addressing both existing acne and preventing future breakouts.

Unlike traditional acne treatments that may involve harsh chemicals or invasive procedures, AviClear offers a non-invasive solution for acne sufferers, minimizing discomfort and downtime. The laser treatment typically carries minimal side effects, making it suitable for many patients.

In conclusion, acne management involves a tailored approach that may include a combination of topical and oral medications, lifestyle modifications, and regular follow-ups to achieve optimal results while minimizing side effects and risks.

RECOMMENDED

BY PCDS AS THE 1ST LINE TREATMENT 1

FOR MILD-TO-MODERATE PAPULOPUSTULAR ACNE PATIENTS 9 YEARS OR OLDER2

Please refer to the summary of product characteristics before prescribing.

Epiduo is contraindicated in pregnancy or in women planning a pregnancy.

1. Primary Care Dermatology Society (May 2024) http://www.pcds.org.uk/clinical-guidance/acne-vulgaris. Last accessed May 2024 2. Epiduo 0.1% Summary of Product Characteristics.

Available https://www.medicines.org.uk/emc/product/451/smpc. Accessed: May 2024

EPIDUO GEL PRESCRIBING INFORMATION (UK AND IRELAND) Please refer to SmPC before prescribing. Presentation: 0.1% adapalene & 2.5% benzoyl peroxide. Indications: Cutaneous treatment of acne vulgaris when comedones, papules and pustules are present in adults, adolescents and children aged 9 Years and over. Dosage and Administration: A thin film should be applied to the entire acne affected areas once a day in the evening to clean & dry skin. If irritation occurs, apply non-comedogenic moisturisers, use the medication less frequently, suspend use temporarily, or discontinue use altogether. Duration of treatment should be determined on the basis of clinical condition; early signs of improvement usually appear after 1 to 4 weeks. The safety and effectiveness of Epiduo have not been studied in children below 9 years of age. Contraindications: Hypersensitivity to the active substances or to any of the excipients. If you are pregnant or planning a pregnancy. Precautions and Warnings: Should not be applied to damaged, broken eczematous or sunburned skin, or come into contact with eyes, mouth, nostrils or mucous membranes (wash immediately with warm water if product enters eyes). Contains propylene glycol (E1520), which may cause skin irritation. Avoid excessive exposure to sunlight or UV light. Avoid contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discolouration. Pregnancy and Lactation: Epiduo should not be used during pregnancy or in women planning a pregnancy. If the patient becomes pregnant while using Epiduo, treatment should be discontinued. To avoid exposure of an infant to Epiduo, application to the chest should be avoided when breastfeeding. Interactions: No interaction studies have been conducted with Epiduo. There are no known interactions with other medicinal products which might be used cutaneously and concurrently with Epiduo. However, other retinoids, benzoyl peroxide or drugs with a similar mode of action should not be used concurrently. Caution should be exercised if cosmetics with desquamative, irritant or drying effects are used, as they may produce additive irritant effects with Epiduo. Absorption of adapalene & benzoyl peroxide through human skin is low therefore interaction with systemic medicinal products is unlikely. Undesirable Effects: Epiduo may cause the following localized adverse reactions: Common (≥ 1/100 to <1/10): dry skin, irritative contact dermatitis, erythema, skin exfoliation, skin burning sensation and skin

irritation. Uncommon (≥ 1/1000 to ≤1/100): pruritus and sunburn. Not known: anaphylaxis, allergic contact dermatitis, swelling face, pain of skin, blisters, eyelid oedema, dyspnoea, skin discolouration (hyperpigmentation and hypopigmentation), urticaria, throat tightness and application site burn.

Most cases of application site burn were superficial burns but cases with second degree burn or severe burn reactions have been reported. If skin irritation appears after application of Epiduo, the intensity is generally mild or moderate, with local tolerability signs and symptoms (erythema, dryness, scaling, burning and pain of skin (stinging pain)) peaking during the first week and then subsiding spontaneously. Prescribers should consult the summary of product characteristics in relation to other side effects. Packaging Quantities and Cost: 45g pump UK - £19.53, IE - € 25.53.

Marketing Authorisation Holder: UK: Galderma (UK) Ltd, Evergreen House North, Grafton Place, London, NW1 2DX, United Kingdom. Ireland: Galderma International, Tour Europlaza, 20 Avenue André Prothin, La Défense 4, 92927 Paris La Défense CEDEX, France. MA Number: PL 10590/0057 (UK), PA 22743/007/001 (IE). Legal Category: POM. Further information is available from: Galderma (UK) Ltd, Evergreen House North, Grafton Place, London, NW1 2DX, United Kingdom, Tel: +44 (0)300 3035674. Date of Revision: April 2023.

Adverse events should be reported.

For the UK, reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

For Ireland, suspected adverse events can be reported via HPRA Pharmacovigilance, www.hpra.ie; Adverse events should also be reported to Galderma (UK) Ltd. E-mail: medinfo.uk@galderma.com Tel: +44 (0)300 3035674

IE-EDG-2400003 I May 2024

34

Acne

Management of Acne Dr Glendinning is a GP specialising in dermatology. She works in Dr Finbar’s Skin Clinic, just over the border in Loughbrickland, County Down.

Written by Dr Christine Glendinning, Dr Finbar’s Skin Clinic.

Facebook: @DrChristineSkinGP

treatment can increase sun sensitivity, but just as much for keeping the skin healthy in later life.

Who to refer for a medical assessment?

A major priority of acne treatment is to prevent scarring, so if the patient has already developed some scars, or if you’re seeing large nodules, pustules or cysts, I’d recommend directing the patient to their GP or dermatologist as soon as possible, as it’s likely they’ll need systemic treatment as well as topical. This will usually entail oral antibiotics, and some will need Roaccutane, which is extremely effective but has numerous side-effects including mood changes. Female patients will need effective contraception.

Among 16–18-year-olds, up to 85% experience some form of acne. Surprisingly though, half of women in their 20s, a third in their 30s, and a quarter in their 40s also experience acne. The disease burden, when considering the frequent impact on mental health and wellbeing, can be comparable to conditions like diabetes or asthma. At Dr Finbar’s Skin Clinic we see many patients with acne each day, from the mild to the most severe end of the spectrum.

for teenagers who are just starting to get acne. It’s quite irritant though, so better to dab on to individual spots. The wash version can cover larger areas and tends to be less harsh on skin, as it stays on for a shorter time.

What causes acne?

Topical retinoids such as adapalene are a popular prescribed option as they’re among the most effective topical treatments. But it’s good to know that they’re available in lower concentrations in numerous commercial creams, in the form of retinol.

Picking at acne exacerbates inflammation and lead to scarring.

Benzoyl peroxide’s effective for drying out particularly troublesome spots. Pimple patches are also a really helpful way to cover pustules and stop picking.

Some of your products will contain salicylic acid which is anti-comedonal and removes dead skin cells. Niacinamide is anti-inflammatory, and specifically improves the redness that lingers after a spot settles.

Emphasise that acne treatments take time to show results. It may

Acne is multifactorial – so there are many ways to help it. It’s true that hormonal factors - androgen production and fluctuations in the menstrual cycle - are the main contributors. But there’s a strong genetic component and as a range of lifestyle factors that are involved, including disrupted sleep, dairy intake, high sugar and high GI index foods. Medication such as anticonvulsants, steroids and the minipill can worsen it – so it’s always worth checking the patient’s drug history.

How do I assess the patient?

Acne may be confined to the face but may also involve the back, chest and neck. In its mildest form it’s comedonal – blackheads and bumpy whiteheads. Moderate acne tends to look red and inflamed, and you’ll see some papules – raised red bumps – and pustules, which are the classic ‘pimple’.

Severe acne has even larger lumps - nodules and cysts. Scarring can occur at any stage and is particularly important to look out for, as we’ll see below.

Helping patients with acne – over-the-counter treatments In mild cases, benzoyl peroxide gel is a great place to start, especially

Azelaic acid, often prescribed as a gel or found in over-the-counter skin serums and suspensions, is less irritant than benzoyl peroxide and useful for patients who describe their skin as sensitive.

Skin care regimes – what to recommend?

So I recommend Cleanse, Active agent, Moisturise, Sunscreen, or ‘CAMS’, to make an acronym!  A non-oil-based cleanser – particularly one that’s labelled as non-comedogenic – used twice a day.  If they have a prescription topical product or OTC gel or serum, apply that ‘active’ preparation next, followed by  a water-based moisturiser  And (in the morning only) finish with a sunscreen of at least SPF 30 and a 5-star UVA rating. The sunscreen’s important as acne

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Similarly, if the acne isn’t as severe but it’s covering the chest or back, topical treatments will be impractical – these patients usually go straight to oral antibiotics or the combined pill.

5 top tips for acne 1. Discourage picking!

2. Encourage patience

take 6-8 weeks for noticeable improvement, and their skin might worsen initially. Avoid frequently changing products!

3. Moisturising is important Moisturising is essential for acne sufferers, including those with oily skin. It helps prevent overdrying, which can increase irritation and trigger more acne. Recommend fragrance-free, water-based moisturisers and caution against facial oils and oil-based products.

4. Offer non-soap cleansers Foaming cleansers that contain soap can strip the skin's natural oils, causing dryness and irritation.

Recommend non-soap-based cleansers that are gentler on skin.

It’s always worth asking patients how their acne’s affecting their day-to-day life – you’ll be amazed how much even a small change, using some of the tips above, can make a difference to confidence and happiness.

Ironically, there are so many skin cleaners and exfoliants available nowadays that many patients are over-exfoliating and over scrubbing their skin, which actually increases inflammation and makes acne worse.

5. Caution against overexfoliation Over-exfoliating can worsen acne by irritating the skin. Advise against daily scrubs, pore strips, or harsh face masks. Recommend gentle exfoliation once a week at most.

IRISH OW

0

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36

Mental Health

‘Hello, How Are You?’: Fostering real connections and mental health support in communities In an era characterised by the frantic pace of modern life and the prevalence of digital communication, genuine human connection can sometimes feel like a scarce commodity. Mental Health Ireland’s mission is to promote and enhance mental health and wellbeing and to create a culture where we are all respected and supported, especially when our mental health is challenged. Our current campaign is called Hello, How Are You? and is about connecting with those around us and engaging in open conversations about mental health. It’s about asking the question, ‘How Are You?’ with meaning, and really listening to the response.

Written by Marie Duffy, PR & Communications Officer with Mental Health Ireland

are listening. Remember you aren’t expected to have all the answers.

• Learn: Seek to understand the person's perspective and validate their experiences. Try to look at things from the other person’s perspective. Ask what has worked in the past. Trust that the person is the expert on themselves and what works for them.

The campaign emerges as a reminder of the profound impact that simple acts of kindness can have on mental well-being. Rooted in the belief that meaningful conversations can change lives, this initiative seeks to destigmatise mental health while fostering a culture of support and understanding.

The essence of the campaign lies in a simple question: "How Are You?" Yet, it's not just about the words; it's about the intention behind them. It's about genuinely caring about the answer and being present to listen. By encouraging individuals, communities, workplaces, friends, and families to engage in open dialogue, the campaign aims to create a ripple effect of empathy and support.

Since its inception, the "Hello, How Are You?" campaign has gained momentum across Ireland.

From distributing conversation cards and bookmarks to facilitating workshops and discussions, Mental Health Ireland has been instrumental in promoting mental well-being through meaningful connections.

By distributing 300,000 conversation cards to people in 2023 alone, the campaign has sparked conversations and

challenged societal attitudes towards mental health.

At the heart of the campaign is the recognition that loneliness often accompanies mental distress.

By nurturing connections and support networks, individuals can combat feelings of isolation and find solace in human connection.

This emphasis on community and belonging underscores the importance of reaching out and checking in on one another, especially during challenging times.

Engaging in meaningful conversations always doesn't require expertise; it requires empathy and sincerity. Mental Health Ireland offers a simple yet effective framework—the HELLO Steps—to guide these interactions: • Hello: Extend an invitation to chat, respecting the person's readiness to engage.

Remember that It’s ok if they say no as they may not be ready to talk. If they say yes, then find a quiet spot to talk.

Bear in mind that now might not be the right time to talk and they might take you up on your invitation another time.

• Engage: Foster an open dialogue by asking openended questions and actively listening. Engage with the

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person by making eye contact with them or whatever feels most comfortable. Be open as possible to the conversation.

It helps to ask open ended questions that don’t require yes or no answers. Phrases like ‘Could you tell me more?’ ‘How does that make you feel?’, ‘What has helped before?’ may be useful. When we begin a conversation, it’s only the tip of the iceberg and it might take time to get to a deeper answer.

You might get an automatic response of I’m ok or I’m fine.

That’s perfectly ok. It takes time to build up trust. This takes us onto the next step • Listen: Demonstrate empathy through both words and body language, creating a safe space for expression. Use words and body language that lets the person know that you

• Options: Empower the individual to explore their options and access support services if needed.

By following these steps, anyone can play a vital role in supporting others' mental well-being. It's about being present, showing compassion, and recognising that small gestures can have a profound impact on someone's life.

In a society where mental health concerns are often met with silence or stigma, initiatives like "Hello, How Are You?" aim to offer something different. They remind us that by fostering connection and empathy, we can create communities where everyone feels respected, supported, and valued. So, the next time you ask someone, "How Are You?", remember, it's more than just a question—it's an opportunity to really listen and meet people where they’re at.

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ABBREVIATED PRESCRIBING INFORMATION Product Name: Cetrine Allergy 10mg film-coated tablets & 1 mg/ml oral solution.

Composition(s): Each tablet contains 10 mg cetirizine dihydrochloride. One ml of the oral solution contains 1 mg cetirizine dihydrochloride. Description(s): White, oblong film-coated tablets, scored on one side. Can be divided into equal halves. Clear, colourless liquid with banana flavour.

Indication(s): Tablets: Adults and paediatric patients 6 years and above. Oral solution: Adults and children 2 years and above. Relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis (hay fever); relief of symptoms of chronic idiopathic urticaria.

Dosage: Tablets: Adults, elderly and children aged 12 years and over: 10 mg once daily. Children from 6 years to 12 years: 5 mg (half a tablet) twice daily. Moderate renal insufficiency (creatinine clearance CrCl 30-49 ml/min): 5 mg once daily. Severe renal insufficiency (creatinine clearance ≤30 ml/min): 5 mg once every 2 days. Children under 6 years: Not recommended.

Oral solution: Children aged from 2 to 6 years: 2.5 mg twice daily (2.5 ml oral solution twice daily (half a measuring spoon twice daily)). Children aged from 6 to 12 years: 5 mg twice daily (5 ml oral solution (a full measuring spoon twice daily)). Adults and adolescents over 12 years of age: 10 mg once daily (10 ml oral solution (2 full measuring spoons)). Not recommended in children aged less than 2 years. Moderate renal insufficiency (creatinine clearance CrCl 30-49 ml/min): 5 mg once daily. Severe renal insufficiency (creatinine clearance ≤30 ml/min): 5 mg once every 2 days. In paediatric patients suffering from renal impairment: Adjust dose on an individual basis taking into account the renal clearance of the patient, his age and his body weight.

Contraindications: History of hypersensitivity to the active substance, to any of the excipients, piperazine derivatives or hydroxyzine. Severe renal impairment < 10 ml/min creatinine clearance.

Warnings and Precautions for Use: Cetirizine may increase risk of urinary retention, therefore caution in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia). Caution in epileptic patients and patients at risk of convulsions. Discontinue use of cetirizine three days before allergy testing. Pruritis and/or urticaria may occur when cetirizine is stopped, even if the symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted.

The symptoms should resolve when the treatment is restarted. Tablets contain lactose. Oral solution contains sorbitol, propylene glycol, sodium (essentially ‘sodium free’), methyl - & propyl-parahydroxybenzoate.

Interactions: Caution is advised when taken concomitantly with alcohol or other CNS depressants. Cetirizine does not potentiate the effect of alcohol (0.5 g/l blood levels). The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.

Pregnancy and Lactation: Caution during pregnancy and breast-feeding.

Ability to Drive and Use Machinery: Usually non-sedative, patients should take their response to the product into account. In sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.

Undesirable Effects: Cetirizine at the recommended dosage has minor adverse effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported. Although cetirizine is a selective antagonist of peripheral H1-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported. Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported which resolves on discontinuation of the drug. Uncommon: Agitation, diarrhoea, pruritus, rash, asthenia, malaise, paraesthesia. See SPC for all adverse reactions.

Marketing Authorisation Holder: Rowex Ltd, Bantry, Co. Cork.

Marketing Authorisation Number: PA0711/075/002-003. 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: March 2021 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

Date of preparation: (04-22) CCF: 24955

Supply status: Supply through pharmacies only.

38

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Stay Hydrated on Your Summer Adventures with O.R.S Hydration Tablets As summer approaches and travel plans and activities with the kids start to take shape, there's one essential element that often gets overlooked: hydration. Whether you're hiking through rugged terrain, lounging on a sun-drenched beach, heading to Summer Camp, or exploring a bustling city, staying hydrated is crucial for maintaining energy levels, supporting bodily functions, and ensuring an enjoyable experience.

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Kids Summer Camps and Activities During Summer Camp season, kids are at a heightened risk of dehydration due to increased physical activity and high temperatures. Dehydration can lead to symptoms such as fatigue, dizziness, and headaches, impacting their ability to enjoy and participate in activities. It's crucial to ensure children drink plenty of water with O.R.S added throughout the day. Dissolve two tablets in 200ml of water and drink as required.

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The mix of electrolytes combined with a low-calorie dose of glucose (17.2 kcal) is not only proven to be the fastest way to restore a healthy level of hydration, it also keeps you hydrated for longer than water alone.

Unlike bulky bottles or powders that can be cumbersome to carry around, O.R.S tablets come in a compact, lightweight tube that easily fits into your pocket, glove compartment, backpack, handbag, or luggage. Having O.R.S tablets

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• 24 tablets – Pharmacy Only • Made in Ireland (Dungarvan) • MRSP* €8.50 • Trade Price €5.67 *price is at the sole discretion of the retailer.

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multidisciplinary team alongside consultant anaesthetist orthogeriatrician Dr Helen O’Brien and pain management CN CPD: Pain analgesia 41 leading to the development and use of post-operative AUTHOR: Marie Richardson Continuing Professional Development

CPD

Marie Richardson is a Senior Pharmacist at Our Lady of Lourdes Hospital (OLOLH) in Drogheda. Marie holds an MPharm from the University of Strathclyde, has over 6 years hospital pharmacy experience, 15 years’ experience working in community pharmacy, has completed an MSc in Clinical Pharmacy from UCC and is currently undertaking an employment-based PhD with UCC, RCSI and OLOLH examining hospital pharmacist prescribing. She has collaborated with a multidisciplinary team alongside consultant anaesthetist Dr Fauzia Bano, consultant orthogeriatrician Dr Helen O’Brien and pain management CNS Gwyneth Mahoko in OLOLH leading to the development and use of post-operative analgesia prescribing guidelines.

200 Word Summary:

60 Second Summary Post-operative analgesia is crucial in enabling patients to mobilise promptly, commence early rehabilitation, have a greater chance of returning to their pre-operative baseline and therefore better long-term prognosis.

Short-acting opioids are preferable to long-acting opioids in opioid naïve patients due to superior effectiveness in managing acute pain, reduced risk of respiratory impairment, and reduced risk of dependence, misuse and diversion. Short acting opioids should be charted both regularly and as required in the immediate aftermath of surgery.

As acute pain subsides, the regular opioid should be weaned down and ceased followed by as required opioids.

Analgesia should be patient specific considering: age, weight, injuries, hepatic function, renal function and titrated to patient functionality and pain.

Post-operative nausea and vomiting, and constipation are very common post-operative side-effects. Patients should have at least one regular laxative prescribed if they are prescribed opioids, except in gastrointestinal surgery where the consultant general surgeon will determine if and when laxatives are needed.

Anti-emetics should be prescribed considering the QTc interval, patient’s other regular medicines and if the patient has Parkinson’s disease.

NSAID’s are best avoided in older patients due to the increased risk of bleeding and acute kidney injuries.

knowledge gap - will thisis article satisfy steps, log and record Post-operative analgesia crucial in4 previous enabling patients to mobi those needs - or will more reading your findings. be required? rehabilitation, have a greater chancePublished of returning to their pre-o

by HPN. 4. EVALUATE - Did this article 2. IDENTIFY - If the answer is no, Copies can be downloaded from meet my learning needs - and how I may still be interested in the area www.irishpharmacytraining.ie better long-term prognosis. has my practise changed as a but the article may not contribute 1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice?

towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.

result? Have I identified further learning needs?

Disclaimer: All material published is copyright, no part of this can be used in any other publication without permission of the publishers and author. Haleon has no editorial oversight of the CPD programmes included in these modules.

Short-acting opioids are preferable to long-acting opioids in opio 5. WHAT NEXT - At this time you may like to record your learning for future effectivenessuseinor managing acute pain, reduced risk of respirator assessment. Follow the 3. PLAN - If I have identified a of dependence, misuse and diversion. Short acting opioids shou as required the immediate aftermath of surgery. acute pa Managing pain inand associated issues in As the should be weaned down and ceased followed by as required opi

post-operative setting

Analgesia should be patient specificresides considering: age, weight, can also be affected: can they be discharged home function and titrated to patient functionality and pain. or do they require additional

Most of us will undergo a surgical on patient recovery and their long-term prognosis. Inadequate procedure at some point in our post-operative pain management lifetime. These can be elective or can result in numerous avoidable acute procedures. However, with consequences that can have a all surgical procedures, there can catastrophic impact on patients be some associated pain and other Managing pain and associated issues in the post-operative setting and their recovery as indicated in side-effects in the aftermath which Figure 1.

Most of us a surgical procedure at some point in our lifetime. These can be elective needs towill beundergo carefully monitored or acute procedures. However, with all surgical procedures, there can be some associated pain and managed.

Delays to early patient post-

rehabilitation or are they unable

reside at home independently Post-operative nausea and vomiting,to and constipation are very in the future? All of this can understandably be very traumatic effects. Patients should have at least one regular laxative pre for patients and their families. opioids, except in gastrointestinal surgery theisconsultant g A furtherwhere consideration that it is and other side-effects in the aftermath which needs to be carefully monitored and managed. predominantly older patients who operative mobilisation has Post-Operative Pain: needed. be with prescrib Post-Operative Pain: and when laxatives present to ourshould acute hospitals potentially are the single greatest Anti-emetics orthopaedic injuries such as hip Management of post-operative impact on the long term prognosis Management of post-operative pain can have a significant impact on patient recovery and their patient’s other regular medicines andfractures if thewhich patient has Parkinso are generally the of themanagement patient. Where the inpatient pain canprognosis. have a significant impact long-term Inadequate post-operative pain can result numerous avoidable consequences that can have a catastrophic impact on patients and their recovery as indicated in Figure 1 below.

most prevalent acute orthopaedic presentation. Every single day a patient is immobile, approximately 4% muscle mass is lost. Most of our acute hip fracture patients tend to be older and frailer, therefore they cannot afford to lose any further muscle mass. To further emphasise the importance of early postoperative mobilisation of hip fracture patients, it has also been associated with reduced mortality.

NSAID’s are best avoided in older patients due to the increased r Psychological Impact injuries.

• Chronic Pain • Depression • Delirium Economic Cost • Increased readmission incidence • Increased length of stay • Additional supports Reduced Mobility • Cannot commence physiotherapy • Increased risk of thromboembolism and pneumonia • Falls & Pressure Ulcers Reduced Sleep & Reduced Physical Function Figure 1: Risks of inadequate management of post-operative pain Delays to early patient post-operative mobilisation has potentially the single greatest impact on the long term prognosis of the patient. Where the patient resides can also be affected: can they be discharged home or do they require additional rehabilitation or are they unable to reside at home independently in the future? All of this can understandably be very traumatic for patients and their families.

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A further consideration is that it is predominantly older patients who present to our acute hospitals with orthopaedic injuries such as hip fractures which are generally the most prevalent acute orthopaedic presentation. Every single day a patient is immobile, approximately 4% muscle mass is lost. Most of our acute hip fracture patients tend to be older and frailer, therefore

Figure 1: Risks of inadequate management of post-operative pain

42

CPD: Pain

If patients were to be immobilised unnecessarily, this will have a significant impact on their long term prognosis and their ability to actively engage with and undertake their rehabilitation program. In turn, this can reduce the likelihood of patients returning home or to their baseline mobility and living as active and as fulfilled a life as they did before their presentation to hospital.

In the elective surgical setting, it is now quite common for patients to undertake a prehabilitation programme i.e. they will be given exercises and advice before their surgical procedure to ensure good muscle tone. This has been shown to have a positive impact on patient mobilisation, recovery and prognosis. However, this is not an option for acute presentations.

prescribing should always be patient specific. Analgesia should consider the patient age, weight, renal function, hepatic function, subjective pain analysis, patient functionality, the type of procedure the patient has undergone, the nature of their injuries, if several pain inducing injuries are noted and any other medication the patient is prescribed.

To put this in context, the postoperative opioid needs of a 93 year old female patient, weighing 50kg, with mild renal impairment presenting with a hip fracture will be markedly different to 45 year old male patient weighting 110kg presenting with polytrauma from a traffic collision who has normal hepatic and renal function, no co-morbidities and no regular medication.

Pain is cited as the main reason noted by physiotherapists for patients being unable to mobilise post-operatively. Therefore, if we can control and manage postoperative patient pain, we can have a significant positive impact on their prognosis and quality of life.

All analgesia prescribed should be carefully monitored, reviewed regularly and titrated to the individual patient requirements and functionality.

Work in OLOLH:

The recommended management of post-operative pain has undergone significant changes in the last decade. Prior to this, it was acceptable to prescribe long-acting opioids in the post-operative setting.

However, significant issues were

A multidisciplinary team in OLOLH including a consultant Anaesthetist Dr Fauzua Bano, consultant Orthogeriatrician Dr Helen O’Brien, Pain Management CNS Gwyneth Mahoko and Senior Pharmacist Marie Richardson worked to develop a post-operative prescribing guideline for the orthopaedic setting.

What is new in post-operative pain management:

arising globally due to misuse, dependence and diversion of long acting opioids.

In addressing this challenge, Hah et al published a paper in 2017 Levy et al published an editorial in 2018 indicating that long-acting opioids should be avoided in opioid naïve patients in the post-operative setting.1,2 An opioid naïve patient is a patient not routinely prescribed or taking opioids.

In 2020, it was followed by the publication of a multidisciplinary international general consensus guideline reinforcing earlier publications, offering clear, concise guidance on how to target the issues of opioid abuse as detailed above.3 Avoidance of long-acting opioids, setting realistic patient pain expectations, regular review and down titration of opioids to cessation,3 utilising only shortacting opioids and short-duration discharge prescriptions were offered as guidance on how to deal with the challenges.

The HSE issued a guidance document in January 2022 “GUIDANCE FOR OPIOID PRESCRIBING FOR ACUTE NONCANCER PAIN, POSTOPERATIVE PAIN AND POST-PROCEDURE PAIN” which sets out clear goals for opioid prescribing in this setting.4 The overall objective of the document is to avoid misuse, diversion

and misappropriation of opioids.

Furthermore, it indicated patient information and education should be provided about opioids and that unneeded opioids and medicine should be safely disposed of at their community pharmacy. It also recommends short-acting opioids are to be prescribed regularly and as required for opioid naïve patients, with a maximum 4 days’ supply of opioids on discharge prescriptions, patients should be down titrated as soon as possible and doses reviewed regularly.

Opioid analgesia is predominantly initiated in acute hospitals and discharge prescriptions are generally prepared by the most junior doctors for patient return to the community setting. It is important that prescribers are aware of this and prescribe safely and appropriately in order to help manage the issues of inappropriate opioid use.

Plan for management: The WHO pain ladder has been the mainstay for a rational stepwise approach to pain management.

The original ladder had 3 steps and solely focused on upward management of pain as it was originally formulated for the management of cancer pain.

However, it was subsequently adopted as a tool for all pain management.

Figure 2: New WHO analgesia ladder indicating bi-directional pain management including a new step 4 ref: Mestdagh et al 20236

It is predominantly Non Consultant Hospital Doctors (NCHDs) who prescribe in the post-operative setting. The goal was that a comprehensive guideline was available for NCHDs to consult, in order to safely and appropriately prescribe analgesia and associated medicines to manage pain and common post-operative side-effects.

Contra-indications to use, cautions in use, dosing guidance, agents in order of preference, dosage adjustments for older patients, and items that needed to be reviewed before prescribing were laid out under 6 distinct headings. The areas on the guideline included: paracetamol, NSAIDs, opioids, laxatives, gabapentenoids and anti-emetics.

Patient Specific: In line with best practice and optimal patient care, analgesia

Figure 2: New WHO analgesia ladder indicating bi-directional pain management including a new step 4 ref: Mestdagh et al 2023(6).

Opioids:

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Opioids are routinely required to manage acute post-operative pain. As detailed above, only short-acting opioids should be used in opioid naïve patients. However, age, renal function, other prescribed medicine and co-morbidities are also a significant consideration, especially for older patients. As we age, our ability to metabolise and excrete medicines naturally declines resulting

possible future use.

When stepping down to step 2 of the WHO pain ladder and utilizing weak opioids such as tramadol and codeine(5), it is necessary to exercise caution and consider their relative potencies 43 compared to morphine as indicated in Figure3 below.

The latest version as detailed in Figure 2 has the addition of a fourth step for interventional treatments and is also bidirectional. This is particularly relevant for the management of acute post-operative pain where treatment starts higher up the pain ladder and is then titrated down as the patient recovers and pain levels reduce alongside their analgesia needs.5 Opioids: Opioids are routinely required to manage acute post-operative pain.

As detailed above, only short-acting opioids should be used in opioid naïve patients. However, age, renal function, other prescribed medicine and co-morbidities are also a significant consideration, especially for older patients. As we age, our ability to metabolise and excrete medicines naturally declines resulting in accumulation of medicines. This is more likely with long-acting opioids and can result in drowsiness, delirium, respiratory depression, confusion and hallucinations.

Short-acting opioids should be prescribed regularly and as required in the immediate aftermath of surgery. Doses should be as per individual patient requirements. Both the regular and as required doses should be reviewed regularly in the context of patient functionality and pain, and titrated to the individual patient needs.

In accordance with Figure 2 above,6 the analgesia prescribed should be reduced, and titrated down as the patients pain reduces and correspondingly their need for opioid analgesia. Patient’s in the acute post-operative setting would usually commence on strong opioids or step 3 of the WHO pain ladder.5,6 Oxycodone: OxyNorm® should be prescribed for regular administration four times per day with additional as required doses charted. The as required doses are crucial for administration approximately 30 minutes before physiotherapists approach the patient and enhance mobilisation and rehabilitation and ultimately ensure optimal pain management and therapeutic outcomes. They can also be administered if needed in between regularly prescribed doses.

Buprenorphine and Fentanyl (100 times more potent than oral Morphine) Oxycodone (2 times more potent than oral Morphine) Morphine Tapentadol (3 times less potent than oral Morphine) Codeine and Tramadol (10 times less potent than oral Morphine) Figure 3: Potencies of opioids Figure 3: Potencies of opioids relative to morphine relative to morphine

Although patients can be reduced to tramadol or codeine products caution should be exercised with older patients. Tramadol can interact with other medicines such as SSRI’s and SNRI’s to increase and seizures.

It can alsoexacerbated cause drowsiness, mood by the common Although patients can be reduced Morphine: the risk of serotonin syndrome to tramadol or codeine products prescribing anti-platelets and changes and dizziness.

It can be administered either caution should be exercised with anti-coagulants in this as Sevredol® 10mg tablets or older patients. Tramadol can patient group.

Paracetamol: ® Oramorph liquid and should be interact with other medicines such prescribed as four times a day o Additionally, non-selective as SSRI’s and SNRI’s to increase Paracetamol is the most commonly prescribed analgesic and is on theNSAID’s first step of thethe WHO for regular administration with increase risk pain of the risk of serotonin syndrome additional asItrequired bleeding 4 fold, while ladder(5). is verydoses well tolerated and can be prescribed for oral, intravenous or rectal and seizures. It can also cause if needed. selective NSAID’s increase drowsiness, mood changes administration. However, consideration of patient weight and hepaticthefunction must 3befold. made risk of bleeding and dizziness.

Tapentadol: prior to prescribing. If a patient is <50 kg, the dose should be reduced to 15mg/kg. o Regular use of NSAIDs has Paracetamol: Palexia® FC tablets can be beenexhibits found to increase Hepatic should reviewedisby If the patient elevatedtheliver prescribedfunction three times a day always be Paracetamol theprescribers. most commonly mortality rate for for regular administration prescribed analgesic and is the function tests (LFTs) indicating impaired ability toonmetabolise medicines bleeds hepatically; gastrointestinal with additional as required first step of the WHO pain ladder.5 to 21%, in contrast to the doses charted.

It is very well tolerated and can be 7% mortality rate observed prescribed for oral, intravenous in patients who do not take Opioid metabolism and or rectal administration. However, NSAIDs. excretion: consideration of patient weight and hepatic function must be • Risk of acute kidney injury Due to the predominant renal made prior to prescribing. If a is doubled within 30 days of metabolism of opioids, dose patient is <50 kg, the dose should commencement of an NSAID reduction may be necessary for be reduced to 15mg/kg. patients with renal impairment • All NSAIDs double the risk of who are prescribed morphine or Hepatic function should always hospitalisation due to heart oxycodone. However, tapentadol be reviewed by prescribers. If failure should avoided in patients with the patient exhibits elevated liver severe renal impairment. function tests (LFTs) indicating • Increased blood pressure, fluid impaired ability to metabolise retention and increased risk of Opioid weaning and tapering: medicines hepatically; paracetamol fatal cardiovascular events dosing should either be reduced or To ensure the safe and effective If NSAID’s are required for older alternatively not prescribed to management of opioids, it is patients in the post-operative avoid further deterioration of recommended to gradually setting, they should be prescribed hepatic functionality. reduce the regular dose before for a short period of time and discontinuing it when appropriate.

Non-Steroidal Antialways prescribed with a proton Additionally, it is important to inflammatories (NSAIDs): pump inhibitor. Low dose as reduce as-needed doses along opposed to maximum doses is with regular short-acting opioid NSAID’s would be a rational choice also preferable.7 In community doses and keep them charted for for use in patients post-surgery pharmacy, regular OTC purchases possible future use. to reduce pain and inflammation of NSAID’s should be borne in accordance with the WHO pain When stepping down to step 2 of in mind. ladder. However, they should not the WHO pain ladder and utilizing be routinely be prescribed to older For younger patients, NSAID’s weak opioids such as tramadol patients for long periods of time can be routinely used. However, and codeine,5 it is necessary to due to:7 consideration should be given exercise caution and consider to their co-morbidities, medical • Older patients are at naturally their relative potencies compared history and other medications higher risk of bleeding due to morphine as indicated in Figure3 below. prescribed. As with older patients to their age, but this risk is

Continued Professional Development supported by

44

CPD: Pain

short-term NSAID use with coprescribing of a proton pump inhibitor is preferable.

Laxatives: Reduced mobility relative to presurgery mobility is normal. This can increase the risk of constipation in its own right. However, in the post-operative setting, patients are routinely prescribed opioids to manage post-operative pain which commonly cause constipation.

This can be uncomfortable and potentially debilitating for patients and reduce their ability to mobilise thereby impeding rehabilitation.

Bowel motion is routinely monitored on surgical wards.8 With this in mind, patients should be prescribed at a minimum one regular laxative if they are prescribed an opioid. The only exception is patients who have undergone gastrointestinal surgery. In this instance laxatives should only be prescribed on and in accordance with the explicit instructions of the consultant general surgeon.

Lactulose should always be prescribed and administered regularly to ensure effectiveness.

Movicol® and senna are also commonly used in this setting.

Phosphate or Microlax® enema’s can be prescribed for as required use.

Gabapentenoids: Post-surgery, certain patients may encounter neurological pain, based on the complexity of the procedure. Gabapentin and pregabalin are potential treatment options that can help manage this type of pain. It is important to note that these medications, like opioids have a high likelihood of being misused leading to misappropriation and dependence. Careful monitoring of their use is essential to prevent any adverse consequences.

When they are prescribed, they should be initiated and used at the lowest effective dose for the shortest period of time necessary.

For instance, gabapentin 100mg three times a day or pregabalin 25mg three times a day prescribed regularly only.

They should be reviewed regularly and ceased when appropriate. It is also prudent to exercise caution when prescribing these agents to older patients, as they may be

more susceptible to orthostatic hypotension symptoms.

Anti-emetics: Post-Operative Nausea and Vomiting (PONV) is a common issue for patients. It can be a side-effect of anaesthesia used during the surgical procedure and can be very prevalent in the first 24 hours post-surgery. PONV is also a common side-effect of opioids which are routinely prescribed in this setting.9,10 PONV is very unpleasant and uncomfortable for patients. It is especially important patients are prescribed an anti-emetic at a minimum on as required basis for the first 24 hours post-surgery to ensure they can rest and recover from the procedure. They should be prescribed separately for oral and/ or intravenous administration. It is often advisable that post-operative anti-emetics remain charted as required for the duration of their hospital admission.

However, the choice of anti-emetic must consider the patient’s comorbidities, other medications prescribed and QTc interval.

Parkinson’s Disease: Parkinson’s disease is a neurodegenerative condition leading to motor symptoms such as tremors, bradykinesia, rigidity, and postural instability due to depletion of dopamine in the substantia nigra of the brain. 15,000 people are currently affected by Parkinson’s disease in Ireland, however as it is the fastest growing neurodegenerative condition, we can anticipate seeing more patients with this condition.

centre. Several anti-emetics exert their effects by antagonising the dopaminergic pathway.

However, given the aetiology and treatment of Parkinson’s disease as detailed above, anti-emetics whose pharmacological actions are mediated via the dopaminergic pathway should be avoided in patient with Parkinson’s disease due to drug-drug interactions which may lead to impaired control of Parkinson’s symptoms.11 The anti-emetics of choice in Parkinson’s disease are: a) domperidone b) ondansetron c) cyclizine Heart Failure: Cyclizine should be avoided in heart failure or acute myocardial infarction as it can cause a reduction in cardiac output.9) QTc interval: Many anti-emetics can prolong the QTc interval. Furthermore, patients are commonly prescribed other regular medication, which they may have been taking pre-admission, which can also cause QTc prolongation. There is an additive effective of adding an additional QTc prolonging medicine to a patient’s medication regimen.12 Common medicines which can prolong the QTc interval includes* citalopram, escitalopram, amitriptyline, amiodarone, clarithromycin, lithium, haloperidol, ivabradine, ranolazine, venlafaxine, tolterodine and sotalol. *Note this is not an exhaustive list of QTc prolonging medicines; check

medicine SPC’s and interaction resources for information.

When we examine commonly prescribed anti-emetics; domperidone, ondansetron, prochlorperazine and metoclopramide, they can all potentially cause QTc prolongation.9 They should therefore not be prescribed to patients who have a prolonged QTc on ECG or if a patient is already prescribed another agent which could prolong the QTc interval. Cyclizine prescribed intravenously and/ or orally is preferred in this instance.

Conclusion: Acute post-operative pain management plays a pivotal role in promoting patient mobilisation.

This in turn has a significant impact on the patient’s longterm prognosis, quality of life and their ability to return to their pre-operative baseline. Short-term use of short-acting opioids as regular and as required analgesia is preferred to avoid dependence, misuse and misappropriation.

The orthopaedic post-operative prescribing guideline in OLOLH, has led to a notable 30% improvement in post-operative mobilisation of patients as noted by our orthopaedic physiotherapists.

Whilst prescribing analgesia correctly and safely is a significant part of post-operative care, other common side effects must also be managed to ensure patient comfort and expedite recovery.

References available on requst

It is treated by administration of medicines that act on the dopaminergic neurological system to aid stimulation of the dopamine receptors in diverse ways:

QUESTIONS

a) levodopa a precursor of dopamine.

True or False

b) dopamine receptor agonists e.g. pramipexole and rotigotine.

b) Patient weight and LFT’s must be reviewed before prescribing paracetamol.

c) monoamine oxidase B inhibitors e.g. rasagiline.

True or False

Nausea and vomiting are mediated in part by the release of dopamine and the activation of dopaminergic pathways in the gastrointestinal tract and chemoreceptor trigger zone. This in turns stimulates the vomiting

a) Long-acting opioid analgesia is preferable in opioid naïve patients in the post-operative setting.

c) Opioid prescribing should always be patient specific.

True or False d) What is the order of preference for anti-emetics for patients who have Parkinson’s Disease? e) What opioid should not be prescribed in severe renal impairment?

Continued Professional Development supported by

Call for papers: make your contribution to Irish Pharmacy News  Articles  Research Papers  Reviews  Programme Descriptions  Reports Case Reports  Letters to editor  In-depth review articles critique fundamental concepts, issues, and problems that define a field of research or practice and support advanced practitioners as well as aspiring early-year pharmacists.  Practice reports share innovations on any area of practice, including delivering clinical services, pharmacy administration, or new approaches to inform and engage with patients with the aim to improving pharmacy practice.  Perspective articles focus on a specific field or discipline and discuss current advances or future directions, and may include original data as well as expert insight and opinions.

Contact: Kelly Jo Eastwood at: kelly-jo@ipn.ie or Aoife Hunter at: aoife@ipn.ie

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46

News

¤17.9m investment for FutureNeuro FutureNeuro, the Science Foundation Ireland (SFI) Research Centre for Neurological Diseases, has announced an ambitious expansion of its research programme dedicated to accelerating the fight against brain diseases. The expansion of the Centre, which is hosted by RCSI University of Medicine and Health Sciences, will be supported with a €17.9m Government investment through SFI. The next phase of investment in FutureNeuro was announced by Minister for Further and Higher Education, Research, Innovation and Science, Patrick O'Donovan, TD; and Minister for Agriculture, Food and the Marine, Charlie McConalogue, TD as part of a formal announcement of new Government investment in four world-leading SFI Research Centres. Colette Daly, a parent and member of the FutureNeuro Public and Patient Involvement Panel, was among those who contributed to a panel discussion at the event.

Brain disease represents one of the most pressing public health and economic challenges of our time, impacting approximately one in three individuals throughout their lives and imposing a profound burden on patients, families and healthcare systems.

FutureNeuro focuses on epilepsy, motor neuron disease (MND), neurodevelopmental disorders, multiple sclerosis (MS), Parkinson’s disease, traumatic brain injury

(TBI), psychosis and the intricate co-morbid aspects of these conditions, such as mental health.

patient journey. The centre’s core areas of focus are diagnostics, therapeutics, and digital health:

drug targets, with an ultimate goal of intercepting disease before it progresses.

Since the initial SFI investment of ¤7.98m in 2017, in its first phase FutureNeuro grew into a ¤44 million national research powerhouse, comparable to other world-leading research centres and generating significant economic, health and societal impact. The centre secured major EU funding awards, partnered with four of the top ten pharma companies and has undertaken pioneering breakthroughs in the areas of precision medicine, genomics, drug development and digital health. This remarkable growth has also helped to expand Ireland's attractiveness as a location for clinical trials.

• In diagnostics research, FutureNeuro aims to develop the next generation of precision diagnostics that combine genetic insights with highresolution measurement of brain structure and function.

And in digital health, FutureNeuro researchers are developing systems that use real-time health data to assist doctors in making informed decisions for improved diagnosis, disease management, clinical trials and health outcomes.

• In therapeutics, the focus is on future treatments, including gene therapies and discovering novel

¤17.9m Government investment from FutureNeuro

In the next phase of the centre, FutureNeuro is adding multiple new research teams across eight higher education institutes to deliver its ambitious roadmap and research challenges as part of its mission to change the

Research Shows Reasons for Presenting for Heart Health Investigations New data has shown that the top reasons why people seek heart health investigations are chest pain at 51%, palpitations caused by possible heart arrhythmia at 30% and heart failure at 10%, according to 2023 admission data from Blackrock Health’s Rapid Cardiac Care Service which is available at Blackrock Clinic, Galway Clinic and Hermitage Clinic. Further research conducted by Blackrock Health last year also showed that 77% of people have experienced one of the symptoms associated with one of these conditions yet almost 20% of people did not take any action regarding their symptoms.

On the back of this data, Consultant Cardiologist Dr Richard Armstrong at Blackrock Health is striving to drive awareness of the most commonly experienced heart health conditions and importantly when to seek medical attention.

experiencing it. Chest pain should always spark action to seek medical attention as there are many conditions related to the heart that should be investigated to ensure the symptom is not masking something more sinister.”

Starting with chest pain, Dr Richard Armstrong said, “Heartrelated chest pain can vary significantly in terms of severity, from quite subtle or a mild discomfort through to crushing or searing pain. A more severe pain should spark an immediate call to 999 to attend the nearest emergency department in case you are experiencing a heart attack, but we know that more milder chest pain can often be put down to other less serious health concerns by the person

Dr Armstrong focused on the area of palpitations caused by a heart arrhythmia as the second most common reason for presenting at the Rapid Cardiac Care Service, “Palpitations can vary in experience from feeling as though the heart beats too fast or slow, or the sensation that the heart is skipping beats. It’s important to seek medical attention if you experience a change in your heartbeat as you might have an underlying heart health issue that needs early intervention and

PHARMACYNEWSIRELAND.COM

management to reduce longerterm damage.”

Heart failure has a very distinct set of symptoms that many wouldn’t associate with a heart condition so awareness of these is important to incite action to seek medical attention. Speaking about heart failure, Dr Armstrong advised, “Heart failure, despite the name, does not mean that your heart stops working entirely but it is an early warning sign of wider heart disease that needs early intervention and management.

Distinct symptoms of heart failure include shortness of breath, swelling in the legs, ankles and feet and very rapid weight gain from fluid build-up. These symptoms occur because the heart muscle is not working as it should to

adequately pump blood around your body causing the blood to back-up. Failing to diagnose heart failure can be life-threatening and can lead to a multitude of other heart health problems, so early diagnosis is key.”

Blackrock Health operates a Rapid Cardiac Care service which provides swift access to its team of cardiology specialists across its three hospitals, Blackrock Clinic, Galway Clinic and Hermitage Clinic, for cardiac patient care, with or without a GP referral. This service provides fast and expert medical care to patients with worrying, acute cardiac symptoms such as chest pain, dizziness, shortness of breath or a racing pulse rate.

Awards The Irish Pharmacy

2024

Excellence. Impact. Innovation Irish Pharmacy Awards 2024 On Saturday, 25th May 2024 over 650 of community pharmacy’s leading individuals, teams and pharma representatives gathered at the Clayton Hotel, Dublin for the biggest night in the pharmacy calendar.

To the public, pharmacy is the most accessible face of the healthcare service.

Pharmacy teams play a pivotal role as a community and health asset across Ireland, striving for excellence in public health care and driving delivery of services focused on prevention, healthcare improvement and protection of their local communities.

Much of this work goes unnoticed but the Irish Pharmacy Awards provide the opportunity to honour and applaud these inspirational and deserving professionals and teams. It is through their work that pharmacy is positioned, at the forefront of healthcare, improving the lives of people across the country.

The Irish Pharmacy Awards are brought to you by Irish Pharmacy News, Ireland’s best and most influential independent community pharmacy magazine.

These Awards recognise the achievements of individuals and teams working in the community pharmacy

sector; their dedication and innovation which positions the profession at the forefront of healthcare, improving the lives of people across the country.

They represent a unique and high-profile opportunity to celebrate the outstanding accomplishments of Ireland’s pharmacy professionals and aim to recognise outstanding examples of high standards, best practice, innovation and excellence.

It has been, and continues to be, the goal of Irish Pharmacy News to recognise the exact added value of the contribution made by community pharmacists and their teams.

The sentiment has been echoed by some of the leading healthcare companies here in Ireland and their support is evident in the most positive way possible with their sponsorship of each of our Awards.

Furthermore, acknowledgement must be given to our prestigious judging panel.

The shortlisting process this year was extremely difficult – with some strong entries failing even to make it as finalists – but it is important to highlight that it’s not just about winning. As double Award winner Mark McPhillips sad, “There is no such thing as a loser, everyone here tonight is winning within the profession.”

14 Awards were given out on the night, and you can read all about the winners on the next pages.

Save the Date: Saturday May 24th, 2025 PHARMACYNEWSIRELAND.COM | 47

Awards The Irish Pharmacy

MGK9299 Haleon Trade Ads.pdf

1

10/08/2022

2024

14:58

Winner

Introducing...

Haleon Self-Care Award 2024

Mark’s Pharmacy Ardee won the Haleon Self-Care Award for 2024.

Mark's Pharmacy in Ardee represents the essence of community healthcare, embodying exceptional service, innovation, and a deep-rooted family ethos. Situated in the heart of Ardee, a town renowned for its community spirit and historical richness, the pharmacy has become a pivotal part of the local fabric.

Haleon, formerly part of GSK

Mark's Pharmacy consistently introduces advanced healthcare solutions tailored to the evolving needs of the Ardee community. From managing chronic conditions to wellness advice, their initiatives reflect a proactive and empathetic approach to health and wellness.

Mark McPhillips said on the night, “This Award of Self-Care means a lot to us as this is something we strive to prioritise every day for our patients. Self-care is a vital aspect of pharmacy and whilst we always strive to make sure we are offering optimum service in this field, it’s always for the betterment of patient care. Receiving recognition for our work makes it all so worthwhile.

“These Awards mean so much to community pharmacy. It’s the coming together which makes us all one big team, and these Awards celebrate that and celebrate all the work we are actively doing as a group.”

Maria McClafferty, Pharmacy Channel Controller with Haleon said, “This is a really important Award within the pharmacy industry so firstly a huge congratulations to all the Finalists and of course Mark and his team on winning.

Haleon Self-Care Award Maria McClafferty, Pharmacy Channel Controller, Haleon with Mark's Pharmacy Ardee

48 | PHARMACYNEWSIRELAND.COM

“Self-care is all about empowering consumers to take action to improve their health and wellbeing and at Haleon we are about better health everyday for consumers. So this Award category is a perfect fit that aligns with our values and we are delighted to be associated with it.”

v

RECOMMEND FOR FAST RELIEF OF TOUGH PAIN

paracetamol/caffeine DUAL ACTIVE FORMULA PROVIDES 30% MORE POWERFUL PAIN RELIEF THAN STANDARD PARACETAMOL1

GENTLE ON THE STOMACH AND NON-DROWSY**

SOLUBLE RELIEF FOR TOUGH PAIN, INCLUDING HEADACHES, PERIOD PAIN AND DENTAL PAIN

FIND OUT MORE AT HALEONHEALTHPARTNER.COM *compared to standard paracetamol. **when used as directed/always read the label before use.

Reference: 1. Laska EM et al. JAMA 1984; 251(13): 1711-1718.

Product Information: Please consult the summary of product characteristics for full product information. Panadol Extra 500mg/65mg Soluble Effervescent Tablets, paracetamol 500mg, caffeine 65mg. Indications: Relief of mild to moderate pain including rheumatism, neuralgia, musculoskeletal disorders, headache, symptoms of colds and flu, fever, toothache and menstrual pain. Dosage: Adults and children 16 years and over: 2 tablets up to 4 times a day. Do not exceed 8 tablets in 24 hours. You may need a lower dose if you are underweight (<50kg), malnourished, dehydrated or if you have alcohol problems. Children aged 12-15 years: 1 tablet up to 4 times a day. Do not exceed 4 tablets in 24 hours. Do not give to children under 12 years.

Minimum dosing interval: 4 hours. Contraindications: Hypersensitivity to paracetamol, caffeine or any ingredients. Precautions: Avoid concurrent use with other paracetamol-containing products. Diagnosed liver of kidney impairment. Patients on concomitant treatment with drugs that induce hepatic enzymes. Patients with depleted glutathione levels or chronic alcoholism or sepsis. Avoid excessive caffeine intake. Caution in those with hereditary sugar intolerance or on a low sodium diet. Should not be used in pregnancy or lactation without medical advice. Caution, due to paracetamol, if administered with flucloxacillin due to increased risk of high anion gap metabolic acidosis. Do not exceed the stated dose. Prolonged use except under medical supervision may be harmful. If high fever, or signs of secondary infection occur or if symptoms persist for longer than 3 days, consult your doctor. Side effects: See SPC for full details. All very rare: Thrombocytopenia, hypersensitivity reactions including anaphylaxis and skin rash, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, bronchospasm, hepatic dysfunction. Frequency unknown: Nervousness, dizziness.

When combined with dietary caffeine intake, higher doses of caffeine may increase potential for caffeine related adverse events such as insomnia, restlessness, anxiety, irritability, headaches, GI disturbances and palpitations. Overdose: Immediate medical advice should be sought in the event of an overdose, even if symptoms of overdose are not present. Legal Category: Supply through pharmacy only. MA Number: PA 678/39/10. MA Holder: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24. Additional information is available upon request. Text prepared: September 2022. Contains paracetamol. Always read the label/leaflet.

Trade marks are owned by or licensed to the Haleon group of companies. PM-IE-PAN-21-00017.

Awards The Irish Pharmacy

2024

Winner

United Drug Business Development (Independent) Award 2024

The United Drug Business Development (Independent) Award was scooped on the night by North Road Pharmacy, Drogheda.

North Road Pharmacy came up with a unique and different idea by opening a Sports Department instore and targeting the individuals who wanted to improve or even begin the road to an active and healthy lifestyle. This proved and is continually proving to display that this was the right decision for the pharmacy.

North Sports is a one-of-a-kind department within North Road Pharmacy which is unique to pharmacy throughout the country and boasts its uniqueness. They stock a wide range of sports equipment, accessories, and sportswear. It bridges the gap between healthy wellbeing and an active lifestyle. North Road are the first and only pharmacy nationwide to include a sports section.

Siobhan Taylor, Pharmacy Owner of North Road Pharmacy (Bradlon Ltd) said, “I am thrilled to win this award as it recognises the hard work and dedication of my team within the business. Their relentless effort and commitment are truly commendable.

Suzanne O’Reilly Burke, Maria Donnelly and Siobhan Taylor, North Road Pharmacy

United Drug Business Development (Independent) Award - Siobhan Taylor, North Road Pharmacy, Drogheda with Sonya Lynch, Senior Key Account Manager United Drug

50 | PHARMACYNEWSIRELAND.COM

“Not only that but it’s their dedication that makes the difference in ensuring the success of our pharmacy.

Everyone enjoys coming into work, we have a fantastic team spirit and foster an atmosphere whereby we support each other whilst supporting our patients and customers. Thank you to United Drug for sponsoring this Award, we have all had an unbelievable night.”

Sonya Lynch, Senior Key Account Manager with United Drug commented, “It has been a difficult year in the pharmaceutical sector and as one of the leading pharmaceutical wholesalers in Ireland it is important for United Drug to sponsor this Award – important for us to recognise the work and the constant dedication that pharmacists and their teams put into the community.”

Congratulations to all winners and nominees Celebrating Excellence in Irish Pharmacy

A Salute to the Innovators, Leaders, and Dedicated Professionals in the Pharmacy Industry. You are all winners.

United, we do better

Contact us: www.udw.ie | 01 463 2300

Awards The Irish Pharmacy

2024

Winner

Easolief DUO Business Development (Chain) Award 2024

TCP Pharmacy in Dublin won the Easolief DUO Business Development (Chain) Award on the night.

Seeing a gap in the pharmacy market, TCP Pharmacy developed a system in 2024 to capture pharmacy clinical interventions.

The clinical intervention system allows the pharmacy team to trend and highlight the pivotal role pharmacists play and our impact on patient safety. The system is used to record all pharmacy recommendations in terms of prescribing excellence and the optimization and safe use of medicines.

TCP has demonstrated their commitment to providing outstanding and exceptional care to their patients by designing and implementing a clinical intervention tool, which has patient safety at its core.

Accepting the Award on behalf of TCP Pharmacy was Alanah Connery, Pharmacist, who said, “This Award truly means the world to us at TCP Pharmacy; it is a real reward for all the hard work that is being done behind the scenes.

Easolief DUO Business Development (Chain) Award - TCP Pharmacy with Samantha Doundoulakis, Marketing Manager, Easolief DUO, Clonmel Healthcare

“For us, even to have reached the stage of being Finalists felt like a huge achievement. There are so many examples of excellence in this room tonight and to be a part of that is a real honour for myself and for the team.

“We have had such as great night and met so many pharmacy peers, both old and new. We are already looking forward to next year.”

Samantha Doundoulakis, Marketing Manager, for Easolief DUO, Clonmel Healthcare said, “Easolief DUO from Clonmel Healthcare is delighted to continue our association with the Irish Pharmacy Awards tonight by sponsoring the Easolief DUO Business Development (Chain) Award.

“Business development is so crucial for pharmacies in this day and age and it really will ensure the sustainability of the sector into the future.

TCP Pharmacy team on stage with Samantha Doundoulakis, Marketing Manager, Easolief DUO, Clonmel Healthcare

52 | PHARMACYNEWSIRELAND.COM

“We at Clonmel Healthcare like to ensure that we support the gate keepers of health in any way we can through partnership with industry. Our driver lies in caring for people’s health as a trusted partner, so we continue to offer pharmacies all the support that we can - together we can continue to innovate and drive new solutions in the market.”

Awards The Irish Pharmacy

2024

Alliance Community Pharmacy Technician of the Year Award 2024

Winner

Emily Ashmore of Adrian Dunne Pharmacy in Ashbourne won the Alliance Community Pharmacy Technician of the Year Award.

Emily is currently working as part of a busy and dynamic Dispensary team. She is a vital part of the pharmacy team and has recently taken up a more senior role. She is eager to learn and is a keen student.

Emily is at the end of her IPU Technician course and has excelled in every part of it. She is self-motivated and it is evident she enjoys learning about all aspects of a Pharmacy Technician’s role.

Her journey from a part-time employee to a lead technician underscores not just her commitment to her role but also her exceptional ability to grow, adapt, learn, and excel in the fast-paced environment of community pharmacy.

She is forward thinking, dynamic and innovative. Her exceptional IT skills have directly contributed to the innovation and improvements in efficiency within the pharmacy.

Emily said after accepting her Award, “This Award means everything to me and I know what it is also going to mean to my team who are always behind me and we work so well together. Every day we show up, happy to be there and ready to get stuck in and so for me, this Award is all of that work for the entire team rewarded.

“I think many people perhaps don’t still understand the amount of work that goes on behind the scenes every day in their local pharmacy and it’s about much more than just dispensing your medication or offering OTC products. Of course it is so much more than that, it’s about looking after the individual and looking after people who have specific needs and making sure that they are happy when leaving the pharmacy.”

Alliance Community Pharmacy Technician of the Year - Emily Ashmore with Natalie Maginnis, Managing Director IPN Communications

Sam Lands, Head of Ireland, Alliance said in advance of the Awards night, “Alliance Pharmaceuticals Ireland is delighted to sponsor the Community Pharmacy Technician of the Year Category. We understand just how important Community Pharmacy is in offering frontline care for a whole array of ailments and conditions, with technicians playing a vital role in supporting consumers and patients alike. Through your dedication and commitment, you enhance the overall customer experience, promote health and well-being, and contribute to the advancement of the pharmacy industry as a whole.

Without you, our pharmacies wouldn’t be able to run as effectively as they do, so thank you from us all!

“Congratulations to all the Nominees this evening, thank you for your never ending hard work and well done to Emily.”

PHARMACYNEWSIRELAND.COM | 53

Awards The Irish Pharmacy

2024

Winner Uniphar Training & Development Award 2024

Adrian Dunne Pharmacy, Trim walked off with the Uniphar Training and Development Award, a new category for 2024.

The management team with Adrian Dunne Pharmacy, Trim are huge believers in the value of quality training for all colleagues. They believe their colleagues should be experts within their own role and where possible cross-trained for other roles and departments to enhance the customer experience. They provide a service that is personable, efficient and one that goes the extra mile for their customers. To achieve that, training is key. They feel training and development has been hugely important for them to retain their team, ensuring they are engaged and motivated to perform.

Amy Regan, Pharmacy Manager with Adrian Dunne Pharmacy Group said, “We are a team that have worked together for many years and to win this Award is super recognition for the work over the years that everyone has put in.

Uniphar Training & Development Award - Amy Regan, Pharmacy Manager and Adrian Dunne, Pharmacy Owner with the team of Adrian Dunne Pharmacy Trim and Jennifer Fitzgerald, Commercial Operations Manager, Uniphar

“We are a local pharmacy with people at the heart of everything we do and therefore training is everything that we are about at Adrian Dunne Pharmacy. All our customers know us by name and we know them by name. We are lucky that we have such a great team, that we have kept for years; we have fantastic retention and that is largely down to efficient training and development.

“I would say to anyone thinking of entering the Awards – Enter, go for it. You have already done all the work to celebrate that the way it should be celebrated and encourage your team.”

Jennifer Fitzgerald, Commercial Operations Manager with Uniphar said, “What an amazing achievement for Adrian Dunne Pharmacy in Trim and a huge congratulations to all the Finalists for getting this far.

Really everyone has worked so hard that despite there can only be one winner, everyone should be hugely proud.

Jennifer Fitzgerald, Commercial Operations Manager, Uniphar with winners of the Uniphar Training & Development Award, Adrian Dunne Pharmacy Trim

54 | PHARMACYNEWSIRELAND.COM

“Uniphar as a company has been evolving for over fifty years in Ireland, as an Irish company working with pharmacy. We know how important it is for those pharmacies to also evolve, learn and to train.

Pharmacies that sponsor learning and development for their own colleagues and for their own pharmacy and industry is something Uniphar is proud to get behind.”

Awards The Irish Pharmacy

2024

Winner

Perrigo Superintendent Pharmacist of the Year Award 2024 Mark McPhillips’ scooped a second Award of the night when he won the Perrigo Superintendent Pharmacist of the Year for 2024.

Mark’s contributions to public health over the last year are extensive and multifaceted, highlighting his role as a community leader in healthcare. In summary, his role has been exemplary in promoting public health. His mentoring of pharmacists and interns, involvement in setting professional standards, introduction of specialised health services, commitment to community education, and pursuit of professional development, collectively underscore his profound impact on community health and the pharmacy profession.

Mark’s impact on Mark's Pharmacy and the Ardee community over the past year has been significant.. His leadership and innovations have led to measurable improvements in both business performance and community health outcomes.

“I am thrilled with this Award. The whole concept of the Awards for us at Mark’s Pharmacy increases staff morale, creates excitement within the pharmacy. To win is the icing on the cake but I have to say without a win it is still always worth it. There is no such thing in my book as a loser, everyone here tonight is winning within the profession.

Perrigo Superintendent Pharmacist of the Year Award - Anne Marie O'Neill, Field Sales Manager at Perrigo with Mark McPhillips, Mark's Pharmacy

“These Awards really raise the standard among pharmacy and also provide us all with a great networking event to meet our fellow colleagues and learn more about what’s happening in other pharmacies across Ireland. That aspect of shared learning is so important.”

Anne Marie O’Neill, Field Sales Manager at Perrigo said, “Congratulations to all the Finalists. This is a fantastic honour for Perrigo to sponsor this Award and to recognise the work Superintendents are doing; we have 3 amazing nominees.

“Perrigo is at the hub of pharmacy, with pharmacy being the main portion of our business. Pharmacists are a central part of all communities so it’s very important for us that we have our brands with these professionals who are caring for customers and offering services to those who don’t often have access anywhere else in the community.”

PHARMACYNEWSIRELAND.COM | 55

Awards The Irish Pharmacy

2024

Winner

BOI Payment Acceptance (BOIPA) Innovation & Service Development (Chain) Award 2024

The BOI Payment Acceptance (BOIPA) Innovation and Service Development (Chain) Award was won by the CarePlus Pharmacy/Navi Group.

The team behind Navi Group and CarePlus Pharmacy have created DispenSense, a cloud-based pharmacy management solution that is the first of its kind in Ireland.

Designed to enhance the efficiency of pharmacy operations while simultaneously improving patient care, the system's robust architecture ensures that DispenSense is not just a software solution, it is a catalyst for positive change within the pharmacy landscape, setting a new standard for resilience and efficiency in pharmacy management.

This cutting-edge software strives to make dispensing reliable, safe and efficient, empowering teams to overcome everyday challenges.

BOI Payment Acceptance (BOIPA) Innovation & Service Development (Chain) Award Barry Gray, Marketing Director, Bank of Ireland Payment Acceptance (BOIPA) with CarePlus/Navi Group

Accepting the Award was Sarah Whelan, Software Product Manager, DispenSense who said, “This is such a great Award for us. Specifically also because it is the Innovation Award – we have carried out innovation in an area of the industry that hasn’t really witnessed innovation in a long time. For us to win this is super important, and we are delighted to be acknowledged within our peers and we aim to keep progressing and supporting the new community and pharmacy environment as it is today.

“The event of Covid has really brought a lot of recognition to the work being carried out by community pharmacy and the availability of care there is to patients. These Awards really recognise the boots on the ground.”

Barry Gray, Marketing Director, Bank of Ireland Payment Acceptance added, “On behalf of Bank of Ireland Payment Acceptance a huge congratulations to all the Finalists for being nominated and shortlisted for these Awards.

“Clearly a lot of work is going on around Ireland right now and this is a great achievement. BOIPA is delighted to be sponsoring the Innovation & Service Development (Chain) Award recognising pharmacy chains that have prioritised innovation to best serve the needs of their customers. We would like to thank the pharmacy sector as a whole for continually going above and beyond for communities across the country.”

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Awards The Irish Pharmacy

2024

Winner

JPA Brenson Lawlor Young Community Pharmacist of the Year Award 2024

Jill Jennings of Hickey’s Pharmacy, Johnstown was crowned the winner of the JPA Brenson Lawlor Young Community Pharmacist of the Year 2024.

Not only that, but the judges were so impressed with the entry for Kostas Papadimas of Donaghmede Pharmacy, he received a Highly Commended Award.

Jill Jennings has really embraced the expansion of the pharmacists’ role in the Johnstown community. She played a strong role in the delivery of both Covid and flu vaccinations in the store.

In addition to her fantastic vaccine performance, she has carried out many health checks in conjunction with the ‘Healthy Meath’ initiative funded by Meath County Council and the Irish Pharmacy Union.

Jill has had a tremendous impact on not only the pharmacy’s business, but the Johnstown community.

Her commitment to educating staff and patients on the importance of overall health, and in particular gut health, has seen the business’ performance thrive. Jill’s dedication to continuous learning and remaining up to date with the latest advancements in pharmacy is evident in her everyday pharmacy practice.

Kostas is known for giving his patients that need counselling so much more of his time, ensuring that they are confident with a new medicine, or where a dose has changed. He has built a great relationship with the local doctor surgeries and has vaccinated many of the local surgery staff. Donaghmede Pharmacy is one of the busiest pharmacies in North Dublin, dispensing being the number one priority and Kostas is great at working under the most intense pressure, while also finding time to vaccinate, take blood pressure readings, serve on the OTC counter and all the other jobs required.

JPA Brenson Lawlor Young Community Pharmacist of the Year - Jill Jennings, Hickey's Johnstown Pharmacy with Jason Bradshaw, Corporate Finance Partner, JPA Brenson Lawlor

Accepting the Highly Commended Award, Kostas said, “I am overwhelmed. To be faced with such amazing competition tonight that are the other Finalists, I am overwhelmed that the judges deemed my work important enough of such an accolade. To even have been nominated and shortlisted is such an honour for me.”

With the winners trophy in hand, Jill commented, “This represents a huge milestone for me in my career, and represents the work, time and effort since beginning my career as a pharmacist. I have definitely been stepping out of my comfort zone and learning so many new things over the last year and to hold this trophy at the end of that feels amazing.”

Jason Bradshaw, Corporate Finance Partner with JPA Brenson Lawlor said on the night, “We have six Finalists here tonight and all of them are worthy winners and excellent young pharmacists.

“Young pharmacists have an ever-growing role and I have been able to meet many of them while providing business lectures to the pharmacy students at Royal College of Surgeons in Ireland (RCSI). I have also had the pleasure of providing 1:1 meetings with interested first time buyer pharmacists in order to assist them with acquiring their first pharmacy.

“JPA Brenson Lawlor provide awards and bursaries for the pharmacy colleges as we believe young pharmacists are the future of pharmacy.”

JPA Brenson Lawlor Young Community Pharmacist of the Year - Highly Commended, Kostas Papadimas and Jason Bradshaw, Corporate Finance Partner, JPA Brenson Lawlor

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Awards The Irish Pharmacy

2024

Winner

Online Pharmacy Retailer of the Year Award 2024

The Online Pharmacy Retailer of the Year Award was won by McCauley Pharmacy Online.

As an online pharmacy, McCauley offers vitamins and supplements, beauty, skincare, fragrance, electrical items, mother & baby care and healthcare services.

They also have an online photo centre with an amazing range of digital prints and cameras and online Doctor service.

The Mccauley App is available for prescription ordering, advice from doctors and online shopping.

The objective as an online pharmacy is to be one of the leading premium skincare, beauty and haircare providers in Ireland. The team are always updating their range to include the newest products on the market that they see fit the McCauley customer.

Sarah Fogarty is Display and UX Manager at Uniphar. She said on accepting the Award, “I am overwhelmed to see our team recognised as being the Online Pharmacy Retailer of the Year. We provide a huge range of services including click and collect to all of our stores nationwide and provide customers with over-the-counter medication to their homes with a next-day service.

“As a team we are over the moon to win this.”

Kevin Clancy, Founding Member, Clare’s Wish Foundation presented the Award. The Irish Pharmacy Awards raised money on the night for Clare’s Wish Foundation.

Kevin said, “Clare’s Wish Foundation was founded in 2013 and is supported entirely by individuals, businesses and community groups. We are the only Irish charity dedicated to providing wishes exclusively to adults with terminal illnesses.

Iris Daly, Shauna O’Rourke, Sarah Fogarty, Shauna Griffiths and Aoife Connaughton from McCauley Pharmacy Online with Kevin Clancy, Co-founder of Clare’s Wish Foundation

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“Our mission is to grant the wishes of Adults who have a terminal medical illness. To enrich their quality of life. A Wish granted provides respite from the normal routines of Hospitals, doctors and treatments. We believe a wish can have a lasting impact that involves the whole family and can create Memories that last a lifetime.”

Awards The Irish Pharmacy

2024

McLernons Independent Community Pharmacy Award 2024

Winner

This year was the second year of the McLernons Independent Pharmacy of the Year Award category. It was won on the night by the team at Village Pharmacy in Carlingford.

The belief and motto of this team has always been “it’s all about you”, and no more is it apparent than in Village Pharmacy. The team’s aim is to ensure every customer leaves the store feeling better after having a pleasant, courteous and professional experience. Everybody works together to make this a reality. During regular team brainstorming meetings, the upcoming events, new ranges, new products and ideas on how to reach and excel in targets for the store, are always discussed.

The store is a pivotal part of the Village and community and is a go to place for many to meet albeit necessary and chat to other locals. All the team understand that most people crossing their door have their own problems and challenges and require professional advice, understanding, careful approach, a listening ear and at times a bit of light conversation to help them.

Siobhan Taylor, Pharmacy Owner at Village Pharmacy (Bradlon Ltd) said, “I am delighted to accept this Award for the team at Village Pharmacy, such an honour to be named as Independent Pharmacy of the Year.

“The pharmacy team at Village Pharmacy go above and beyond every day; they work together for the benefit of the whole community. I am so honoured that they have been recognised for their pursuit of excellence and team-building.

“What these Awards do, is give validation and admiration to a team. We all know they are doing a great job but it’s important they know that.”

Robin Hanna, Sales Director, with McLernons said, “McLernons are honoured to once again sponsor the Independent Pharmacy of the Year Award. We have 4 fantastic finalists, who are all winners in their own right but huge congratulations to Village Pharmacy on their success.

McLernons Independent Community Pharmacy of the Year - Robin Hanna, Sales Director, McLernons with Nikki Reilly, Siobhan Taylor, Pharmacy Owner and Niamh Ruddy, Village Pharmacy

Robin Hanna, Sales Director, McLernons, Siobhan Taylor, Pharmacy Owner, Village Pharmacy, Nikki Reilly, Manager, Claire O’Neill, Pharmacist, both Village Pharmacy and Marty Whelan

“McLernons have been involved with the Irish Pharmacy Awards since their inception; 12 months have passed since the last fantastic Awards night, and in that time, over 100 million items have been dispended by pharmacy teams, they have delivered healthcare into the heart of the community and so to have an evening like this whereby they can celebrate and collaborate is hugely valuable.

“These teams work so hard, with their own challenges, and it is truly rewarding to be a part of this acknowledgement and recognition which they all so greatly deserve.”

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Awards The Irish Pharmacy

2024

Winner

Reckitt Community Pharmacist of the Year Award 2024

The Reckitt Community Pharmacist of the Year for 2024 went to Michelle O’Hagan of Pharmacy Hub Killinarden.

Michelle is an advocate for her patient’s health, and for the health of the local community. She is heavily involved with South Dublin County Partnership and their HSE health promotion officers. She regularly has the smoking cessation officer in the pharmacy, carrying out clinics and providing information to the community on the free HSE We Can Quit Smoking Cessation programmes. She runs vaccination clinics, all year round for covid vaccines, and the seasonal flu vaccine.

She is also an advocate for mental health and wellbeing, getting personally involved in the ‘Darkness into Light’ campaign (Pieta House) every year and the ‘Hello, How are you’ campaign (Mental Health Ireland) in 2023. She organised for the Marie Keating Mobile Unit to visit the pharmacy in October 2023 (for Tallaght Health Awareness Month) to encourage breast cancer health awareness.

Michelle also enrolled the pharmacy in the IPU Safe Pharmacy initiative, and ensured all staff completed the training and that the pharmacy can be seen as a safe space for those who fall victim to domestic violence.

Reckitt Community Pharmacist of the Year - Michelle O'Hagan, Pharmacy Hub Killinarden with Adam Lee, Country Manager, Ireland, Reckitt

After accepting her trophy Michelle said, “I am shocked yet honoured to win the Reckitt Community Pharmacist of the Year Award. This means everything to me on a personal level having been in pharmacy for over thirty years. My team that I have behind me believe in my vision for what community pharmacy can do and that it’s more than just the 4 walls.

“These Awards present the perfect opportunity to shine a spotlight on pharmacy, something we don’t often get a chance to do. Quite often we are in the shadows or behind the scenes and not always totally comfortable with the spotlight so it’s huge for us that the team at IPN behind the Awards and all of the sponsors are putting our work out there and giving us the chance to come out and take a bow.

Not only do we get so much out of it, but so do our teams and our communities.”

Adam Lee is Country Manager, Ireland, with Reckitt, and he told us, “Can I firstly offer my congratulations to all the Finalists for getting this far. It is a huge honour to be here tonight in this capacity out of all your peers in the industry and to be recognised as one of the best pharmacists in Ireland.

“Pharmacy and pharmacists are at the heart of what we do at Reckitt; self-care is very important to us. These pharmacists are at the front line of ensuring that patients are taking the right products and the right medications for their illnesses and that is something which we hold as valuable.

“We are looking forward to working together in the year ahead to drive more positive change in communities nationwide.”

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Awards The Irish Pharmacy

2024

Athlone Pharmaceuticals Counter Assistant of the Year Award 2024

Winner

In what was an extremely hotly contested Category, Jenny Percival from Ryan’s Pharmacy in Derrinturn won the Athlone Pharmaceuticals Counter Assistant of the Year Award.

Jenny has had a huge impact on her pharmacy team and the community. It is very clear immediately that Jenny goes above and beyond time and time again. Nothing is too much of an ask or too far beyond Jenny’s reach. Her pharmacy in Derrinturn is treated with so much love and attention.

To many customers, Jenny is a counsellor, a friend to listen, a source of valuable healthcare information, a “free” courier service, an out of hours point of contact, always someone to have a joke and a laugh with to brighten your day, a personal shopper, a trusted salesperson, a forward planner/budgeter (ringing customers to tell them something they might like has come in, noticing them that a sale is about to happen), a first aider, the main point of contact even for their dispensary related queries, and a mother figure.

Jenny told us after receiving her Award, “I am so humbled but also delighted to receive this Award, which I have to say is also a reflection of my entire team and how well we work together.

“The recognition these Awards brings to the profession is un-rivalled. I would say to anyone who is thinking of entering – just go for it. Our whole community got behind us, we were inundated with good wishes and messages, the entire process has been exciting and so uplifting for all of us.”

Barry Doyle, Head of Athlone Pharmaceuticals added, “At Athlone Pharmaceuticals, we are very proud to sponsor the ‘Counter Assistant of the Year’ Award. It is never an easy task to shortlist from a cohort which demonstrate such high standards of professionalism and caring on a daily basis. It is important to support and acknowledge the people at the front line of healthcare, who are there to offer help and advice to the public when they need it.

“All of the Finalists here tonight are so deserving of this recognition and we know what this means to them. This is our first time sponsoring with the Irish Pharmacy Awards and we hope it will be the first of many.”

Athlone Pharmaceuticals Counter Assistant of the Year - Barry Doyle, Head of Athlone Pharmaceuticals with Jenny Percival, Ryan's Pharmacy, Derrinturn

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Awards The Irish Pharmacy

2024

Winner

Viatris Community Pharmacy Team of the Year Award 2024

The final Award of the evening – the prestigious Viatris Community Pharmacy Team of the Year Award went to Hilton’s Pharmacy in Cornelscourt.

Hilton’s Pharmacy is a community pharmacy, which to them means that they strive to provide exceptional pharmaceutical care to their community, demonstrating a commitment to delivering a personalised service for their patients, accurate medication dispensing and compassionate patient counselling.

Their goal is to enhance the health and well-being of every patient they serve. Through dedication, teamwork and a patient centred approach, they strive to be a trusted pillar in their local community supporting all of their patients on their healthcare journey. The team embrace every challenge with a smile and a laugh along with a dedication to deliver what is asked of them. It is this togetherness and enjoyment of each other’s company that has allowed the business to thrive.

Viatris Community Pharmacy Team of the Year Award - Hiltons Pharmacy Cornelscourt with James O'Connor, Hospital and Pharmacy Sales Lead, Viatris Hilton’s Pharmacy, winners of the Viatris Community Pharmacy Team of the Year pictured with Marty Whelan, David Gilsenan, Pharmacy Owner and James O’Connor, Hospital and Pharmacy Sales Lead, Viatris

David Gilsenan, Pharmacy Owner said, “I have had my pharmacy and worked in my pharmacy for 21 years and my team is simply incredible. I have never enjoyed working more because of the group around me. I see every day how much dedication they put into their work, both for themselves and for their colleagues and, most of all for the customers and the patients they deal with every day.

“This is really their Award, I am only accepting it as a representative, this is definitely their prize.

“Community pharmacy offers an incredible service all around the country and these Awards recognise the general excellence that is being carried out and how we all strive to provide optimum care and service. Tonight is a perfect demonstration of how much pride we all take in our profession.”

James O’Connor, Hospital & Pharmacy Sales Lead with Viatris added, “We are honoured to present the Viatris Community Pharmacy Team of the Year Award. Viatris is the coming together of three pharma companies, Meda, Mylan and Upjohn and across our five sites in Ireland we employ over 1,600 people. Their primary purpose is to provide medicines access to patients so that they can live healthier.

“I personally am delighted to congratulate the eight Finalists who have all demonstrated dedication and commitment and are all extremely worthy nominees. Huge congratulations to Hilton’s Pharmacy.”

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Awards The Irish Pharmacy

Irish Pharmacy Awards The Best of Pharmacy

2024

Over 650 pharmacy and industry professionals were in attendance as winners across 13 categories were announced at the annual Irish Pharmacy Awards.

Each year Irish Pharmacy News, Ireland’s only independent monthly publication for community pharmacy, celebrates and acknowledges the achievements of teams and individuals within the pharmacy profession.

The 13th annual Irish Pharmacy Awards took place on Saturday, May 25th 2024. Hosted by Marty Whelan, the awards ceremony took place in the Clayton Hotel, Burlington Road, Dublin.

The Irish Pharmacy Awards recognise the achievements of individuals and teams working in the community pharmacy sector; their dedication and innovation which positions the profession at the forefront of healthcare, improving the lives of people across the country.

Pictured are some of those who attended.

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1. Derek and Angie Reilly, Irish Pharmacy Union 2. Erik Jackman, Rosemary King, Nadia Pustoshilova, Zita Canao and Fergus McCauley, IQVIA 3. The pharmacy team from Corach Pharmacy 4. David Beggs, Pure Pharmacy and Guests 5. Karen Ferris, Shauna McElligott, Mary Kelly Cunningham and team from LloydsPharmacy 6. Abigal Byrne, Sinead Kennedy, Jill Jennings, James Coughlan, Hickey’s Pharmacy Johnstown

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Awards The Irish Pharmacy

2024

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1.LloydsPharmacy guests all smiles for the camera 2.The team from Uniphar and Hickey’s Pharmacy Northside 3. Susan Concannon, Emily Ashmore, Georgina Llenas-Bastardas, Lisa Cooper, all from Adrian Dunne Pharmacy, Ashbourne 4. Ciaran Sheehy and Ann Browne, Newpark Life Pharmacy 5. Oonagh O’Hagan and Elizabeth O’Hagan, Meaghers Pharmacy Group 6. The pharmacy team from McCartans Pharmacy Group

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1: The Ryans Pharmacy team enjoying the night 2. Nazum Nahar, Ayia Shakerdi, Bernie Walshe, Stefania Grigoras, Catherine Hanlon and Blathnaid Scanlon, McCartans Pharmacy 3. Paul Hatton and Anne Marie O’Neill, Perrigo 4. Clodagh Conlon, John Kavanagh and Orla Kelly, Ryan’s Pharmacy 5. Frank and Grace Olden, Hickey’s Pharmacy 6. Keith McLernon, Managing Director, Robin Hanna, Sales Director, Anne Marie McWilliams, Communications Manager and the team from McLernons

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Awards The Irish Pharmacy

2024

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4 1. Gloria Carretero and Piero Cambursano, Pharmacist, Netwownpark Pharmacy 2. All smiles for the Irish Pharmacy Awards 3. Adrian Dunne Pharmacy Group 4. Dean Kehoe and Sadhbh Whitty, McCauley Pharmacy 5. The team from McCabes Pharmacy Group

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1. Patrick McCormack and the team from Cara Pharmacy 2. Julianna Sceleder and Loretta Dignam, The Menopause Hub 3. The teams from Millmount Pharmacy, Village Pharmacy and North Road Pharmacy, Bradlon Ltd 4. McCabes Pharmacy enjoying the Irish Pharmacy Awards 5. The pharmacy team from Chemist Warehouse 6. Eoin McCartan with Kostas Papadimas and guest

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Awards The Irish Pharmacy

2024

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1. Juste Lileikyte, Mary Butler and Laura Manley, Pharmacy O’Regan, Moorefield 2. Mark Beddis, Kostas Papadimus and guests, Donaghmede Pharmacy 3. Jenny Percival and team from Ryans Pharmacy 4. Paddy Gahan, Ger Gahan, Tara Kelly and Martin Kelly, Irish Pharmacy Union 5. Dee O’Dwyer, Dr Greens, Sally El Banna and Ola El Garawany, Lilly’s Pharmacy 6. The team from Viatris

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Launches New Packaging Design

Simplified, clear and easy to read packs.

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Products are differentiated through colour

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Key information is displayed on the sides, allowing for the best use of limited shelf space

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No two packs have the same drug and strength colour

5mg 10mg 20mg 40mg

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User-friendly pack experience, with a linear read hierarchy

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Simplified back-of-pack clearly structures additional information

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

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

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

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

Date of Preparation: March 2024 | Job Code: GEN-IE-00059

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

Awards The Irish Pharmacy

2024

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5 1.​John Carroll, Susie Morrissey, Deirdre McLoughlin, Maria Lettice, Jean Tomkins, Joey McNamara and team from Navi Group 2. Adam Lee, Ciaran Leonard, Peter Mulvihill, Laura Herbert, John Clince, Philippine Massie and Ismena Kielkowska, Reckitt 3. Michelle O’Hagan and the pharmacy team from Pharmacy Hub, Killinarden 4. Jade Byrne, Aislinn Lea, Barbara Kelly and Arlene Gleeson, Excel Recruitment 5. Emma McLoughlin and Eimear Hillard, PCO 6. The teams from United Drug, LloydsPharmacy and PHX Ireland

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BEST IRISH PHARMACY BRAND Voted By Irish Pharmacists

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Judges on Zest Active

“Great product – does exactly what it says. Customer feedback is always positive regarding how well it works and they will purchase again.”

Judges on Beauty Complex

“Superior product, formulated to the highest degree. All products in the range are excellent. I love it because its Irish and has different products to suit the needs and lifestyle of everyone.”

Judges on the Revive Active Range

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Menopause

Optimising Health after Early Menopause The average age of menopause in women in the UK is 51. The onset of perimenopause is around 45. Some women may however go into menopause earlier than this. Menopause between 40-45 is referred to as early menopause. Premature ovarian insufficiency (POI) is when menopause occurs below the age of 40.

Dr Genevieve Ferraris, The Menopause Hub

Either HRT or the combined oral contraceptive pill (containing ethinyl estradiol) may be used, however HRT may be more beneficial for bone and cardiovascular health. Hormone replacement aims to maintain normal physiological levels of estrogen and should be continued up to the average age of natural menopause.

Mental health implications

Early menopause and POI are defined as the loss of normal ovarian activity. Ovulation is diminished and the ovaries produce insufficient levels of estrogen. This clinical syndrome is characterized by erratic or absent periods, raised gonadotrophins (FSH and LH) and low estradiol levels. The prevalence of POI is approximately 1%.

An early menopause may be spontaneous or induced/iatrogenic.

The etiology of spontaneous POI is wide ranging, including chromosomal and genetic defects (like Fragile X syndrome and Turner syndrome), autoimmune disorders, infections, exposure to environmental toxins and idiopathic.

Iatrogenic causes include radiotherapy, chemotherapy and surgery (oophorectomy).

What are the symptoms of early menopause?

The most common symptoms of POI and early menopause are loss of periods and vasomotor symptoms (hot flushes and night sweats). Other symptoms include mood changes, insomnia, genitourinary symptoms and brain fog. However up to 14% of women with POI will not experience symptoms.

What are the long term implications of early menopause?

Early menopause has consequences not just for fertility,

but also impacts bone health, cardiovascular health and neurological function long term. Awareness that these effects may have long-term consequences has led to the hypothesis that POI, and early menopause, may be associated with higher mortality rates.

Multiple studies have shown that POI is associated with an increased risk of coronary heart disease, heart failure and stroke, as well as an increased mortality from these diseases.

Estrogen plays an important role in regulating and maintaining bone structure in women. POI has been associated with a reduction in bone density and an increase in fractures. Observational data show that 8-14% of women with POI develop osteoporosis.

Observational studies have also shown an increased risk of cognitive impairment and dementia in women with early menopause.

Hormone Replacement Therapy (HRT) Hormone replacement has a beneficial role for women in early menopause. In addition to providing good symptom control, it will also help to maintain bone and cardiovascular health and neurological function. It is likely to reduce the long term risk of cardiovascular disease, prevent osteoporosis and have a beneficial effect on cognition.

PHARMACYNEWSIRELAND.COM

For most women, a diagnosis of early menopause or POI can be a challenging experience.

They may feel isolated as their peers are not yet going through menopause, there can be a sense of loss of identity and femininity, and the possibility of not being able to conceive naturally can be very distressing. They are also often experiencing symptoms which are unpleasant and may exacerbate low mood or anxiety.

These women should be offered support as required – including HRT, referral to mental health services as appropriate, and/or antidepressant therapy. Support groups can be of great benefit – The Daisy Network is a UKbased charity aimed at providing information and support for women with POI. Exercise The benefits of exercise can’t be overstated. In women with early menopause and POI it is important for maintaining bone density and good cardiovascular health, improving mood and cognitive function, and helping to support a healthy weight. The question is often – how much exercise and what type? The WHO recommends 150-300 minutes of moderate to vigorous exercise per week. The biggest benefits seem to come from combining regular aerobic exercise (like walking, running, dancing, tennis or cycling) with resistance training (weight lifting).

Strength training in women has enormous benefits – by lifting weights we are maintaining healthy muscle mass (which reduces with age), supporting good bone and heart health, improving mobility and preventing falls, improving metabolic health and reducing the risk of dementia. For many women the thought of going to a gym and

lifting weights can be daunting, but you can consider going to a women’s only gym, working with a trainer initially to build up your confidence, or doing workouts from the comfort of your home.

Healthy Lifestyle A healthy lifestyle is really important for women with early menopause and POI. Besides exercise, other ways to look after your health during this rime include: • Stopping smoking • Reducing alcohol • Ensuring adequate intake of calcium in your diet – through foods such as dairy products, nuts and seeds, green leafy vegetables, sardines and tinned salmon • Maintaining adequate vitamin D levels – often a daily supplement is required as this is made in the skin after exposure to sunlight and many people in the Northern Hemisphere are vitamin D deficient • Eating a balanced, Mediterranean-type diet – that is plenty of vegetables and fruits, lean good quality protein, wholegrain carbohydrates and healthy fats • Stress management with practices like meditation, journaling and breathing exercises Conclusion Early menopause can have significant long-term implications for women, with increased risk of cardiovascular disease, osteoporosis and cognitive impairment. Both physical and mental health should be supported during this time.

HRT should be offered to these women up until the age of natural menopause (if no contraindication), and patients should be counseled on the importance of exercise and maintaining a healthy lifestyle.

If required patients should be referred for mental health support, and should have access to support networks.

News

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School of Pharmacy Host HSRPP Conference The School of Pharmacy at University College Cork recently hosted the 30th Health Services Research and Pharmacy Practice (HSRPP) Conference on 25-26 April 2024 in Cork, the theme of which was 'Sustainable Development in Healthcare'.

The conference attracted over 110 national and international delegates from over 15 countries across a range of disciplines, bringing together leading experts in the areas of health services and pharmacy research, as well as pharmacy practice and education.

sustainability in healthcare. Through keynote speakers, workshops, oral presentations, and poster presentations, we had a packed programme exploring innovative strategies to ensure sustainable healthcare delivery with the patient at the centre of our efforts.

Professor Stephen Byrne, Deputy President and Registrar of UCC, opened proceedings, acknowledging the rich and impactful history of the HSRPP conference, while also emphasising UCC’s commitment to sustainability. The conference co-chairs, Dr Suzanne McCarthy and Dr Kieran Dalton, outlined the main goal of the conference – to provide a forum to share ideas, innovations, and best practices aimed at enhancing developing

The conference’s exciting line-up of keynote speakers included: • Barry Melia, Principal Pharmacist at Public Health Scotland: ‘Environmental Sustainability – A public health perspective’.

• Carmel Hughes, Professor of Primary Care Pharmacy at the School of Pharmacy, Queen’s University Belfast: ‘Move fast and break things: Efficiency and sustainability in development and implementation of

interventions focusing on medicines use in older people’.

• Debi Bhattacharya, Professor of Behavioural Medicine at the University of Leicester: ‘Embracing the diversity of research methodology to develop interventions’.

Several engaging and informative workshops were delivered during the conference on topics such as: sustainability, exploratory research, human factors, public and patient engagement, and health literacy.

Oral Presentations 1st Prize: Ita Fitzgerald 2nd Prize: Frank Moriarty and Maria Donovan (Joint) 3rd Prize: Darren Walsh

Poster Presentations 1st Prize: Sarah Wilson and Aisling McGowan (Joint) 3rd Prize: Rosemary Lim Speaking after the event, Dr Suzanne McCarthy and Dr Kieran Dalton said, “We would like to sincerely thank the HSRPP Conference steering committee, Pharmacy Research UK, our esteemed speakers, workshop leaders, sponsors (including Fáilte Ireland and UCC), the dedicated team at the School of Pharmacy, including our postgraduate students who were wonderful conference ambassadors, and all attendees who contributed to making HSRPP 2024 a great success.”

Calls for All-Ireland Cancer Institute An Tánaiste Micheál Martin has called for an All-Island Cancer Institute, stating initiatives such as the (opens in a new window)All-Island Cancer Research Institute (AICRI), a partnership of 10 universities which UCD co-leads, has shown a cross-border approach to cancer can deliver better outcomes for patients.

Citing the hugely successful ‘Ireland-Northern Ireland-US National Cancer Institute Cancer Consortium’, which celebrates its 25th anniversary this year, the Tánaiste said he favoured the establishment of an All-Island Cancer Institute while speaking at the inaugural Joint EuroAmerican Forum on Cancer at Farmleigh House.

An Tánaiste Micheál Martin, Professor Alberto Costa, Special Advisor to EU Health Commissioner Stella Kyriakides and CEO of the European School of Oncology, Professor Mark Lawler, Professor of Digital Health at Queen’s University Belfast and Co-Lead of AICRI

Echoing the sentiment, (opens in a new window)Professor William Gallagher, Professor of Cancer Biology at UCD School of Biomolecular and Biomedical Sciences, and co-lead of AICRI, said he “wholeheartedly agree with the Tánaiste’s call for an All-Island Cancer Institute”.

“Our work in AICRI has demonstrated the benefit of working together on a crossborder basis. Projects such as AICRIstart, funded through the Shared Island-funded North South Research Programme, emphasise the importance of collaborative research. Critical areas of all-island partnership should encompass cancer biobanking, crossborder cancer clinical trials, and survivorship research.”

Support for All-Island Cancer Institute was also raised by Professor Deirdre Heenan, Ulster

border collaboration, coupled with the evidence linking quality research to better care and improved outcomes for patients,” said Professor Lawler.

An Tánaiste Micheál Martin University, and Professor Mark Lawler, Queen’s University Belfast and Co-Lead of AICRI at the forum, as they jointly launched the ‘Cancer Knows No Borders – an all-island blueprint for cancer research and care’ at the conference.

“Our data are compelling, demonstrating how the quality of research increases with cross-

“We firmly believe that a dataenabled patient-centred All-Island Cancer Institute would deliver unparalleled benefits for the health and wealth of our societies North and South. Cancer Knows No Borders, neither should we.”

Doctor Julie Gralow, Chief Medical Officer of the American Society for Clinical Oncology (ASCO), who with Professor Lawler was Scientific CoChair of the Forum concurred.

“These two days of discourse and debate have firmly embedded the

concept of enhanced transatlantic cooperation as a means of delivering research-enabled enhanced cancer care on the island of Ireland. An All-Island Cancer Institute would be the logical next step.”

Professor Heenan added: “We aim to bring together the combined strengths of cancer researchers, clinicians, academics, and service users across the island of Ireland to create a blueprint to tackle this common enemy.

“This is an opportune time to redouble our efforts to significantly improve services and outcomes for cancer patients throughout this island.”

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74

Anticoagulants

Anticoagulation therapy in the context of women’s health Written by Dr Katie Liston Haematology Specialist Registrar in Haematology and Dr Maeve Crowley Consultant Haematologist, Cork University Hospital anaemia was iron deficiency (www. who.int/news-room/fact-sheets/ detail/anaemia). During this period, women have an increased requirement for iron in the form of menstruation and pregnancy.

Iron supplementation outside of dietary sources is not always easy to tolerate so once you become iron deficient, it can be difficult to resolve. This is important in the context of anticoagulation as if you know menstruating women are commonly anaemic at baseline, putting on a treatment that leads to increased and prolonged bleeding is only likely to make things worse.

Heavy menstrual bleeding (HMB): HMB is common and can be caused by structural issues (e.g. polyps, leiomyomas, malignancy or adenomyosis) or non-structural issues (e.g. anovulatory cycles, medications, coagulopathy); (Samuelson Bannow B et al.

Res Pract Thromb Haemost.

2021 Aug). Consequences of and antiphospholipid syndrome.

Background: Anticoagulants HMB include iron deficiency are frequently prescribed Anticoagulants remain high risk +/- anaemia, impaired quality of medications. In Ireland, direct medications (https://ipu.ie/wplife, missing school/work, missed oral anticoagulants are the content/uploads/2022/03/highdoses ofhealth anticoagulation due to anticoagulants of choice in most risk-medicines.pdf). face Anticoagulation therapy in theWomen context of women’s fear of HMB and missing out on cases but vitamin K antagonists specific and evolving bleeding and social activities and sport. A 2015 still have a vital role to play, thrombotic challenges throughout European survey (Fraser IS et al. especially in the management of their lives (Figure 1.)

Int J Gynaecol Obstet. 2015 Mar) patients with metallic valves Written

by Dr Katieheart Liston Haematology Specialist Registrar in Haematology and Dr Maeve Crowley Women and Iron deficiency: found that ~27% of the women Consultant Haematologist, Cork University The WHOHospital estimate that ~half a surveyed had experienced 2 billion women worldwide aged or more HMB symptoms in the 15-49 are anaemic.

In 2019 30% Background: Anticoagulants are frequently prescribed medications.

In Ireland, direct previous year; 46%oral of these of non-pregnant and but vitamin women never consulted anticoagulants are the anticoagulants of choice inwomen most cases K had antagonists still have a 37%of pregnant women in this a physician about it. 7% of vital role to play, especially in the management of patients with metallic heart valves and age group were anaemic and the respondents completed an Figure 1. Bleeding and the most common of this extended survey – 63% of these antiphospholipid syndrome. Anticoagulants remaincause high risk medications (https://ipu.ie/wpThrombotic Challenges Faced content/uploads/2022/03/high-risk-medicines.pdf).

Women face specific and evolving bleeding and

by Women. HRT=Hormone Replacement challenges Therapy. thrombotic throughout their lives (Figure 1.)

women had been diagnosed with iron deficiency or iron deficiency anaemia but only 46% had been prescribed supplementation. To identify menstrual problems, it’s important to know what is normal.

A normal cycle length is 21-35 days with each cycle lasting 2-7 days and a median blood loss of 57ml/cycle. HMB is a loss of > 80mls/cycle or excessive menstrual blood loss that interferes with a woman’s physical, social, emotional, or material quality of life. It is important to identify if a woman has an underlying menstral disorder prior to starting them on anticoagulation as we know that anticoagulation is likely to make things worse. About 2/3 of women on anticoagulation experience heavy menstrual bleeding and almost ¾ of women on rivaroxaban (De Crem N et al. Thromb Res. 2015 Oct).

Table 1. Clinical Features of Heavy Menstrual Bleeding Changing sanitary products more than every 2 hours or requiring double protection Leaking or soaking through clothing or needing to change sanitary products overnight Periods lasting >7 days Passing clots >2.8cm (1.1 inch) When trying to assess if a women has an underlying menstrual disorder, Table 1 contains some things to ask women about.

Starting a menstruating women on anticoagulation: It is good practice to try to address 4 issues when starting a menstruating women on anticoagulation. (Figure 2.)

This is particularly important if a patient is going to be on indefinite anticoagulation. If a women has underlying menstrual disorders, they may need further investigations such as imaging or a review by a gynaecologist or haematologist. Different anticoagulants have different risk of menorrhagia so agent choice is important. If a women has always had HMB and sinister causes have been out-ruled, it is better to consider measures early to

Figure 1. Bleeding and Thrombotic Challenges Faced by Women. HRT=Hormone Replacement Therapy.

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Women and Iron deficiency: The WHO estimate that ~half a billion women worldwide aged 15-49

When trying to assess if a women has an underlying menstrual disorder, Table 1 contains some things to ask women about.

Starting a menstruating women on anticoagulation: It is good practice to try to address 4 issues when starting a menstruating women on anticoagulation. (Figure 2.) to ask about as they also have an antiplatelet effect. It may not be possible to stop these medications but at least you can flag that the patient may be at a higher risk for bleeding and counsel them regarding this.

Hormonal therapy: The combined oral contraceptive pill (COCP) is associated with an increased risk of venous thrombosis. Women are prescribed it for many reasons, including contraception, HMB, acne, endometriosis, polycystic ovarian syndrome, dysmenorrhoea, cycle regulation.

It is important to find out what the indication for the COCP was when you are considering if it should continue or be changed to an alternative. Whatever their indication, it is reassuring the note that if a women is on therapeutic anticoagulation, then their risk of recurrent VTE appears similar if Figure 2. Issues to address when starting a menstruating women on anticoagulation.

HMB Heavy they are on= oestrogen containing Menstrual Bleeding. therapies or no hormonal therapy (Patel JP et al. Res Pract Thromb Figure 2. Issues to address when (Martinelli I et al. Blood. 2016 ongoing starting a menstruating women This is particularly important if a patientHaemost. is going to2023). be on The indefinite anticoagulation. a women has Mar).IfTherefore, if a woman is randomized MEDEA (Hamulyák ENas imaging on anticoagulation.

HMB = Heavythey may underlying menstrual disorders, need further investigations such or a on review by remaining anticoagulation, et al. Res Pract Thromb Haemost.

Menstrual Bleeding. can stay so on the COCP but if a gynaecologist or haematologist. Different anticoagulants have different risk ofthey menorrhagia 2020 Dec) study will hopefully they been are stopping anticoagulation, agent choice is important. If a women has alwaysfurther had HMB and sinister causes have out-ruled, provide evidence to guide an alternative needs to be it is better to consider measures early toagent ameliorate issue rather than risk the woman choicethe in the future. found. Different modalities have different levels of efficacy in terms Concurrent medications: It is of contraception thrombosis important to review a patients risk and amenorrhoea rates regular medications to look for (DeLoughery E et al. Hematology drug-drug interactions as well Am Soc Hematol Educ Program. as those that may increase the ameliorate the issue rather than 2022 Dec). Exploring these bleeding risk. Co-prescription of risk the woman experiencing factors allows clinicians to antiplatelet agents increases the significant bleeding. Ensuring counsel women about the most risk of bleeding. The prescription that women are iron replete is appropriate modality for them. of an anticoagulant may negate vital as you are lowering their the need for an antiplatelet agent.

Tranexamic acid (TXA): TXA is bleeding threshold so you want to Selective Serotonin Reuptake an antifibrinolytic agent which ensure they have some reserve. In experiencing significant bleeding. Ensuring women are iron replete is vital as you areoflowering Inhibitors that (SSRIs) are commonly stops the breakdown clots. general, a multifaceted approach prescribed antidepressant A Danish historical prospective their threshold so you want to ensure they have some reserve.

In general, a multifaceted worksbleeding best. medications. Many of the cohort study attempted to approach works best. haemostatic functions of platelets Anticoagulant choice: estimate the risk of thrombosis are mediated through serotonin Rivaroxaban appears to be in women aged 15-49, not on Anticoagulant choice: Rivaroxaban to be associated highest rates with of menorrhagia, soappears SSRIs potentially can makewith the theanticoagulation associated with the highest rates a standard when compared withcompared apixaban, dabigatran or warfarin Bannow B et al. ResThey Pract haemostatic function of(Samuelson platelets of menorrhagia, when risk of thrombosis. looked at less andlife increase with apixaban, dabigatran on 2 million women Thromb Haemost.

2021)or– see Table 2. effective Quality of is alsothe differentlydata impacted (Patel JP et followed al. Res bleeding risk (Ann Med. 2022 Dec). warfarin (Samuelson Bannow B et for 13.8 million person years. The Pract Thromb Haemost. 2023). TheOver ongoing randomized MEDEA (Hamulyák EN et al. Res Pract the counter medications such al. Res Pract Thromb Haemost. incidence of venous thrombosis Thromb Haemost.

2020 Dec) willnon-steroidal hopefully provide further evidence to guide choice in anti-inflammatory 2021) – see Table 2. Quality of study as appeared to be agent increased but the life isfuture. also differently impacted drugs (NSAIDs) are also important number of women who needed the

75 to get a 5 day course of TXA to cause harm was >78,000 (Meaidi A et al. EClinicalMedicine. 2021).

There was no increased risk of thrombosis in the high risk patients recruited to the CRASH2 and WOMAN studies which is reassuring. It is frequently used in the prevention and management of bleeding in patients with bleeding disorders. It is not well studied in patients with thrombosis or on anticoagulation. A survey of clinicians’ prescribing habits showed that there is often a reluctance to use it in the acute setting, with 1/3 of those surveyed never prescribing it in the first 3 months and 46% very concerned with the risk of progression or recurrence. (Abdulrehman J et al.

Thromb Res. 2024 Jan).

Conclusion: It’s important to be both frank and open when starting a woman on anticoagulation.

Heavy Menstrual Bleeding is common, especially in woman on anticoagulation. Women are often reluctant to talk about it without prompting. Discussing where they are at present in terms of menstruation and their past experiences will help you predict how they will be on anticaogulation. If they are anaemic or iron deficient, this is a good time to address it.

Anticoagulation stewardship is an emerging movement focusing on the appropriate use of anticoagulants, which persist in being high risk medications despite the availability of newer agents. Choosing the correct agent, following consideration of patient and disease factors, at the correct dose, for an appropriate duration should ensure maximum efficacy with the minimal amount of harm.

Educational resource: The team in Kings College hospital have developed a short educational video for patients entitled ‘anticoagulants and your periods’ which is freely available on youtube https: //youtu.be/kAIirzFVFKc?si=IrSfQUGvygKQcZDS

Table 2. Relative risk of Heavy Menstrual Bleeding by choice of Anticoagulant.

Anticoagulant Incidence of uterine Relative risk CRNMB/MB Warfarin 4.5%-9.6% Reference Apixaban 5.4% 1.18 Edoxaban 9.0% 1.26 Rivaroxaban 9.5% 2.10* Dabigatran 4.7% 0.53*

*statistically significant , P<0.01. CRNMB= Clinically Relevant Non-Major Bleeding. MB=Major Bleeding. Adapted from ‘Management of heavy menstrual onClinically anticoagulation’ Bannow B. Hematology Soc Hematol Educ *statistically significant , P<0.01. bleeding CRNMB= RelevantSamuelson Non-Major Bleeding.

MB=Major Am Bleeding.

Adapted Program.

2020 Dec of heavy menstrual bleeding on anticoagulation’ Samuelson Bannow B. Hematology Am Soc from ‘Management Hematol Educ Program. 2020 Dec

Concurrent medications: It is important to review a patients regular medications to look for drugdrug interactions as well as those that may increase the bleeding risk. Co-prescription of antiplatelet agents increases the risk of bleeding. The prescription of an anticoagulant may negate the needPHARMACYNEWSIRELAND.COM for an antiplatelet agent. Selective Serotonin Reuptake Inhibitors (SSRIs) are commonly prescribed

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Empowering Individuals to Feel their Best Nuasan, is an Irish, natural body care brand focusing on total body wellness and recovery.

Nuasan’s founder, Dara Scott

Originally developed for athletes, Nuasan was designed to address body and skin issues commonly experienced by this group including body and muscle recovery, joint support, skin and foot problems. However, its customer base has now expanded far beyond this, encompassing individuals from all walks of life seeking relief from joint pain, arthritis, menopausal symptoms, sleep issues, and more.

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When he returned home to Ireland, he bought his first beehive and started developing Hive Alive – a natural food supplement for bees that strengthens and protects honeybee colonies. Hive Alive is now sold in over 40 countries and is the number one natural food supplement for bees worldwide.

Dara’s active lifestyle continued once home but his body was not recovering at the pace it used to. Unhappy with the selection of products available to him and taken aback by the lack of supportive body care products for athletes, particularly endurance athletes, triathletes, and marathon runners, he decided to create something for himself. He was confident in the power of natural ingredients from his work on Hive Alive and determined to use only high quality, functional, natural ingredients. He spent 4 years researching and developing an entire range of natural body care products to specifically support athletes and active lifestyles and, in early 2020, Nuasan was born.

Despite a rocky start to the brand, launching at the beginning of the Covid-19 pandemic, Nuasan has gone from strength to strength and has a brilliantly loyal following of customers amongst the athletic community. Its recent launch in Boots Ireland has opened the door to an entirely new customer and the range is being used to support people with joint pain and arthritis, women with perimenopausal symptoms, those with recurring fungal and bacterial foot infections and those struggling to sleep.

Nuasan is launching in Holland & Barrett Ireland this coming summer 2024 and the team have set their sights on the US and the UK. Nuasan Active CBD Muscle Gel is their bestseller and provides targeted, warming relief for muscles and joints. It contains a high concentration of CBD to combat discomfort and inflammation, Chilli extract to give instant warming relief and a unique blend of plant extracts to support recovery. This gel comes in an easy to squeeze tube and absorbs rapidly without leaving a residue on the skin. It is perfect for use pre

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78

Advertorial

Novel plant-based hormone-skin-inflammasome approach to treating adult female hormonal acne Adult female acne happens when hormonal imbalances increase sebum production, accelerating skin sebum production and thereby increasing the possibility of C. acnes colonization of hair follicles. The timing and positioning of this acne, usually on the chin, jawline, and neck, indicate that it is hormone related.

This type of acne occurs most often around the menstrual cycle and is especially common in women who have excess androgens, insufficient estrogen, or chronically elevated stress hormones (like cortisol).

Therefore, in additional to topical management, hormonal imbalance and chronic inflammation must be simultaneously addressed in patients.

Written by Barbara Paldus, pictured with Codex Lab's Products

• Holy Basil (Tulsi) is an herb commonly used in Ayurveda.

Studies have suggested that it can be used to relieve anxiety, stress, and depression. It may also be associated with a decrease in glucose levels, inflammation, and joint pain, and help enhance the body’s immune system.

• Turmeric root extract is an herb also commonly used in Ayurveda due to curcuminoids that possess anti-inflammatory properties and has been studied on various skin conditions such as psoriasis, itchy skin, oral lichen planus, facial redness, and certain forms of skin cancer.

Acne Hormone-SkinInflammasome Axis The premenstrual period - when estrogen levels are lowest and progesterone levels are increasing – is characterized by higher sebum production, making hormonal acne flares one of the primary symptoms of premenstrual syndrome (PMS). Elevated levels of male hormones - androgens like testosterone or androstenedione or a higher-than-average sensitivity to progesterone may also lead to hormonal acne.1 About 10% of adult women experience polycystic ovary syndrome (PCOS). Not all women with PCOS will experience hormonal acne, and for those that do, its severity can vary. Acne in PCOS tends to appear more as tender knots under the skin, rather than the surface bumps of regular hormonal acne.

High cortisol levels from chronic stress or lack of sleep have recently been correlated with the severity of acne2,3 as well. Elevated cortisol levels and increased inflammation are now frequently linked: the older 'glucocorticoid resistance' model is being updated to a model where cortisol

possesses immune potentiating properties and may thus directly cause the increased inflammation.4 Chronic inflammation plays a significant role acne because it activates the inflammatory response in skin: pro-inflammatory cytokines stimulate excess sebum production and disrupt normal skin cell shedding. This leads to clogged pores, overgrowth of C. acnes, and pus-filled pimples.5 In addition, chronic inflammation and immune cell activity can compromise the skin barrier and negatively affect its ability to protect the body.

Clinical-Grade Ayurvedic Solutions for Acne Vulgaris In view of the hormone-skininflammasome axis, a plantbased supplement that combines anti-inflammatory and hormonemodulating actives can provide an alternative treatment to traditional oral contraceptives and spironolactone. Recent clinical studies demonstrate that Codex Labs’ Shaant Skin De-Stress supplement helps reduce acne lesions by 61% within 8 weeks. It contains a blend of four Ayurvedic plants and four dietary supplements:

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• Milk thistle extract is derived from the milk thistle plant. One of its primary active ingredients, silymarin, is used for its antioxidant, liver-supporting, and anti-inflammatory properties. It is thought to possess beneficial properties like doxycycline for acne.

• Barberry extract is used in Ayurveda to promote vigor and a sense of well-being.

Scientifically, berberine not only is anti-inflammatory and antibacterial, but the antilipogenic effect of barberry on the sebaceous glands may further support its effectiveness as an anti-acne agent.

administration of inositol has been found to significantly reduce plasma testosterone, free testosterone, and insulin (where insulin resistance can cause chronic inflammation).

• Folic and Pantothenic acids are water-soluble vitamins that are typically used for conditions such as depression, stroke, and decline in memory. They have also been shown to improve insulin resistance and decrease testosterone levels.

Local topical Management of the Acne Inflammasome Many standard acne topicals like benzoyl peroxide or strong retinols may further perturb an inflamed skin barrier, strip the microbiome, or lead to excessive dryness during acne treatment.

The ShaantComplexTM is clinically proven to reduce sebum overproduction via the successful regulation of endocannabinoid pathways that manage inflammation of the sebaceous glands, inciting desquamation, along with pore diameter reduction. Together these effects prevent clogging of the pores and promote skin homeostasis to maintain epidermal structure and function by balancing skin cell proliferation and apoptosis, all in a microbiome-friendly manner.

• L-theanine is a water-soluble non-protein amino acid found in green/black tea and mushrooms, that is believed to promote relaxation, by modulating aspects of brain function resulting in a significant decrease in stress- and anxiety-related symptoms.

It is composed of both terrestrial and marine plants:

• Methylsulfonylmethane (MSM) is a naturally occurring organosulfur compound used for reducing inflammation, joint and muscle pain, and oxidative stress.

• Green Microalgae (Tetraselmis chui) help decrease sebum production

• Inositol (myo-inositol) is a carbocyclic that mediates cell signalling in response to hormones and is used to help manage polycystic ovary syndrome (PCOS). Consistent

• Ghotu Kola (Centella asiatica) helps reduce redness and supports wound healing • Patchouli (Pogostemon Cablin) soothes and helps enhance skin homeostasis via CB2 receptors

• Spiral Wrack (Fucus Spiralis) helps comfort irritated skin with anti-inflammatory polysaccharide fucoidans.

The ShaantComplex™ is supplemented by other Ayurvedic plants.

References available on request

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New Data shows High Protection against Shingles New long-term data show Shingrix continues to provide high protection against shingles in adults aged 50 and over for more than a decade GSK plc has announced positive data from the ZOSTER-049 long-term follow-up phase III trial which followed participants for up to approximately 11 years following initial vaccination with Shingrix (Recombinant Zoster Vaccine or RZV). The final trial data demonstrate that RZV maintains efficacy against shingles for more than a decade in adults over 50. The data presented at the European Congress of Clinical Microbiology and Infectious Diseases (ESCMID) in Barcelona, Spain (27–30 April 2024) is based on the ZOSTER-049 study.

The results from ZOSTER-049, an extension from two phase III clinical trials in adults aged 50 and over (ZOE-50 and ZOE-70), include:  The primary endpoint focused on cumulative vaccine efficacy (VE) in the period from year six to year 11 after vaccination, with 79.7% VE observed in adults aged ≥50 (95% CI 73.7–84.6)  VE in adults ≥50 remained high within each individual year after initial vaccination in ZOE-50 and ZOE-70, with VE in the 11th and final year at 82.0% (95% CI 63.0–92.2)  High VE rates were observed across all age groups over 50 years of age, including the ≥70 group which had a cumulative VE of 73.1% from six to 11 years after vaccination (95% CI 62.9–80.9)

Dr Javier Díez-Domingo, Principal Investigator, FISABIO (Foundation for the Promotion of Health and Biomedical Research of the Valencian Community, Spain) says, “These final data demonstrate continued protection with the Recombinant Zoster Vaccine over more than a decade with high efficacy maintained in both the 50+ and 70+ age groups.

Infectious diseases like shingles pose a significant risk to adults due to the natural decline in our immune system, and these data represent a remarkable advancement in our understanding of what can be achieved long-term for effective protection against shingles.”

Dr. Edel Doorley, MICGP, Rowan Family Practice, added, “Preventative medicine is a key part of my medical practice. With this in mind, I regularly recommend the Shingrix vaccine to patients over 50 years of age because of its strong protection against Shingles and Post Herpetic Neuralgia. It's great to know that the protection lasts more than a decade.”

Philip Dormitzer, Senior Vice President, Head of Vaccines R&D, said, “We are delighted with the conclusions from this trial, demonstrating that the Recombinant Zoster Vaccine can provide long-term protection for adults aged 50 and over against shingles, a disease that can have debilitating impacts and potentially severe complications. These data

go far beyond the typical long-term follow-up period for a trial, tracking the efficacy of RZV vaccination for some participants as they aged into their 80s and 90s. With RZV now included in many national immunisation programmes around the world, these data add to the body of evidence on the extended long-term protection against shingles provided by RZV and provide further confidence to inform public immunisation strategies.”

Globally, shingles will affect up to 1 in 3 people in their lifetime.

As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.

A variety of factors can increase the risk of developing shingles, including advancing age and immunodeficiency or immunosuppression, as well as other chronic conditions such as COPD, diabetes, and asthma.

The risk of shingles complications, such as post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years, also increases with age. PHN is the most common complication of shingles, occurring in 5–30% of all shingles cases from findings in various studies.

The World Health Organization estimates that by 2050, the world’s population of people aged 60 years and older will double

to 2.1 billion. The ageing of the population will place more people at risk of developing shingles and its complications. Shingles is also associated with significant healthcare and human cost, with 1–4% of cases requiring hospitalisation, while 57% of people with shingles reported missing work for an average of 9.1 days.

ZOSTER-049 is a phase III openlabel, long-term follow-up trial from two pivotal phase III randomised clinical trials (ZOE-50, ZOE-70).

The trial evaluated the efficacy, safety, and immunogenicity in adults 50 years and over at time of vaccination, for six additional years after completion of the ZOE-50 and ZOE-70 trials, up to approximately 11 years of follow-up.

ZOSTER-049 included over 7,000 participants from 18 countries across five continents, with vaccine recipients compared to historical controls.

No new safety concerns were identified during the followup period in ZOSTER-049. No serious adverse events were considered causally related to RZV vaccination by the investigators. In adults aged 50 years and over, the most frequently reported adverse reactions with RZV are pain at the injection site, myalgia, fatigue and headache. Most of these reactions were mild to moderate in intensity and generally lasted less than three days.

Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. By age 50, VZV is present in most adults, and may reactivate with advancing age. As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.

Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face. The pain is often described as aching, burning, stabbing or shock-like.

Following the rash, a person can also experience post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years. PHN is the most common complication of shingles, occurring in 5–30% of all shingles cases from findings in various studies.

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Supplementation

83

The Experience of Anaemia and Ingesting Oral Iron Supplementation in Pregnancy: A Qualitative Study Written by F.E O'Toole1, 2, E. Hokey1, F.M McAuliffe1,2, J.M Walsh1,2 1 UCD Perinatal Research Centre, University College Dublin, National Maternity Hospital, Dublin, Ireland 2 National Maternity Hospital, Dublin, Ireland Highlights • Qualitative research exploring anaemia and supplemental iron in pregnancy.

• Gastro-intestinal side-effects and forgetfulness negatively impact compliance.

• Improvement in symptoms, routine and alternate day dosing all aid compliance.

• Patient knowledge on possible negative sequelae of anaemia was limited.

Introduction Iron deficiency anaemia is the most common haematological problem in pregnancy. It affects approximately 38 % of women in pregnancy globally. Crosssectional data from fifteen European countries gives a prevalence of iron deficiency anaemia in pregnancy of 35 %.

Prevalence of iron deficiency anaemia in pregnancy from an audit encompassing 86 maternity units across the United Kingdom and Ireland was 30.4 %. It remains a common problem in Western well-nourished nations despite these countries being much less afflicted by helminths, malaria or haemolytic conditions.

Significant adverse pregnancy, maternal, foetal, neonatal and childhood outcomes are associated with iron deficiency anaemia. Maternal complications include fatigue, post-partum haemorrhage, increased risk of caesarean section, postpartum anaemia, blood transfusion, and labour induction. Infant complications include preterm birth, low birth weight infant, increased risk of stillbirth, lower Apgar scores at delivery and increases in perinatal and

neonatal mortality. Symptoms of anaemia include fatigue, breathlessness, and dizziness.

Postpartum anaemia has been linked to depression, fatigue, lactation failure and early cessation of breastfeeding.

Maternal anaemia has also been associated with behavioural and neurodevelopmental abnormalities in offspring.

Iron deficiency anaemia in pregnancy has a multitude of contributing causes including physiological changes and inadequate nutrient intake, rates will depend on baseline iron stores pre-conception.

Women of reproductive age are at increased risk of anaemia due to menstruation. Acute blood loss can also occur from miscarriage, placental events such as abruption or praevia or recent childbirth resulting in postpartum haemorrhage. Both breastfeeding and pregnancy deplete maternal iron stores. The iron demands of pregnancy can cause an iron deficit even in iron-replete women.

Insufficient dietary iron intake may compound the problem.

Iron deficiency anaemia in pregnancy can be challenging to treat. The hormonal and physiological effects of pregnancy predispose women to slowed gut transit, hemorrhoidal disease, heartburn, nausea, vomiting.

Oral iron supplementation is the recommended first-line treatment and is often commenced as both a diagnostic and therapeutic trial without further investigations, as iron deficiency is commonly the underlying cause of anaemia.

The commencement of oral iron in pregnancy may exacerbate pre-existing pregnancy-induced gastro-intestinal disturbances or may cause new unpleasant gastrointestinal side-effects to include nausea, vomiting, constipation, abdominal discomfort, and black stools. Advice on optimal absorption of oral iron will typically be to take in the morning, on an empty stomach and with a

source of vitamin C. Women are generally advised to increase their dietary iron and often given advice on foodstuff that may hinder absorption. Compliance with treatment can be limited secondary to side-effects, among other factors.

Rates of iron deficiency anaemia in pregnancy appear to be relatively unchanged over the past two decades, despite treatment being affordable, accessible and in theory straight-forward.

The World Health Organization Global Health repository data only demonstrated a 4 % reduction over a twenty-year period to a prevalence of 37 %. The 2017 World Health Organization Global Nutrition Targets include a 50 % reduction of anemia in women of reproductive age by 2025.

There a paucity of published qualitative data from higher income countries on women’s experience of taking oral iron in pregnancy.

This study was performed to examine the lived experience of ingesting supplemental oral iron to treat anaemia in pregnancy.

We specifically wished to explore women’s awareness and experience of this problem both before and during pregnancy, their awareness of any potential negative sequelae of untreated anaemia, how they felt about the role of diet in its management, and what factors contributed negatively or positively to their compliance with oral iron supplementation in pregnancy. Feedback was also sought on acceptability of a proposed randomized controlled trial of daily versus alternate day oral iron for the treatment of confirmed iron deficiency anaemia in pregnancy. This project successfully answered these research questions.

Materials and methods Recruitment for this qualitative study performed between 4th November 2021 and 17th December 2021. Ethical approval

was obtained in advance of recruitment by the National Maternity Hospital Research Ethics Committee (EC23.2021).

Informed written consent from each participant was obtained in advance of an interview. Pregnant or recently pregnant women who required iron supplementation in pregnancy were invited to take part in interviews. Women were invited to participate in the study via social media channels such as on the UCD Perinatal Research Centre Twitter account and women were also approached for study participation during antenatal hospital visits. Ethically approved patient information leaflets on the study and study-specific consent forms were provided in advance of participation and an opportunity to ask questions was provided.

Interviews were audio-recorded virtually or in person using the audio function in Zoom (Zoom Video Communications Inc. 2016).

Interviews were then transcribed using Sonix (Sonix, Inc. San Francisco, 2021). To ensure patient confidentiality all transcripts were anonymised and allocated a unique study identifier (P1–P14) and the audio files were destroyed.

Interviews were carried out by one member of the research team (FOT). This researcher was a female obstetric trainee performing research as part of an MD thesis.

There was no prior relationship with any of the interviewees.

Participants were provided with clear typed information regarding the study and the researcher’s background and role as part of the consent process in advance of participation. Consent forms were stored on a secure server and could not be linked to the transcripts to ensure participant confidentiality. No medical records were accessed as part of this study and participants contact details were deleted following a two-week period after the interview. Participants were offered an opportunity to review their anonymized typed transcript

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Supplementation for a two-week period after the interview. After this period, their contact details were destroyed as per the consent form and planned management of their data.

P8- “I did have people telling me in the first pregnancy that I looked pale, and they were like you’re anaemic. You need to take iron.

Other Mums were telling me.”

The interview took the following format: an interview tool comprising of 5 open-ended questions for semi-structured interviews was developed by the research team. Interview length varied between 14 and 17 min duration. There was scope for exploratory questions on new themes. Open-ended questions were asked of each participant surrounding their awareness of iron deficiency anaemia both before and during pregnancy, their knowledge of its symptoms and of potential sequelae, how big a role they felt diet played as part of management, and their experience of taking iron tablets in pregnancy.

Factors affecting compliance with oral iron supplementation were explored. Finally, each participant was asked about how acceptable they felt participation in a randomized controlled trial of daily versus alternate day iron would be to other women. Details of what participation in the trial would involve was outlined and feedback was sought on how acceptable they felt this would be.

P13- “I was aware, because of all my sisters who’ve gone through pregnancy. I know it’s quite common now.”

The anonymized transcripts were then analysed separately by two members of the research team (EH, FOT). Data saturation was felt to be reached with clear recurring themes.

Individual analyses were compared, and agreement of themes and subthemes was reached through discussion. Rigour in the analytic process was ensured through review and confirmation of themes by other members of the team (FMcA, JW).

Main findings Overall, there appeared to be a varied awareness that iron deficiency could become a problem in pregnancy. Prior awareness was sometimes from previous personal experience, and often from anecdotal reports from friends or family who had previously been pregnant.

Personal experience ranged from experience of anaemia as a teenager, vegetarianism, and during work-up for a history of subfertility. Often, however, it was their first pregnancy that initially highlighted the problem to them.

Women described being warned of it as a potential problem more in their initial pregnancies:

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With regards to participants’ experience of symptoms of iron deficiency anaemia in pregnancy, significant and depleting fatigue was a recurring theme. Women described it as a more severe fatigue than previously experienced: P2- “I was absolutely exhausted and the tiredness, it’s just inexplicable if you’ve never been pregnant. It’s a completely flattening experience.”

Knowledge and awareness on the potential effects of untreated anaemia on the pregnancy and baby were limited. Participants did not demonstrate good knowledge on the potential negative consequences/sequelae for themselves in their pregnancy or afterwards in the postpartum period. Awareness and knowledge of potential foetal sequelae such as childhood iron deficiency was poor: P8- “No actually, I don’t. I’m not aware of any of the effects in pregnancy of untreated anaemia for me in pregnancy or for the baby in the long-term.”

With regards to the lived experience of ingesting oral iron in pregnancy, the unpleasant side-effects of ingesting oral iron were a commonly recurring theme. Constipation and nausea appeared to be the most frequently described and troublesome: P2- “It did not agree with me at all, it was absolutely horrendous to take. I got constipation, I got heartburn. It just really played havoc with my digestive system.

Made me nauseous if I took it without food, it was really hard. It was really unpleasant to take.”

P12- “It helped me, but the sideeffects were horrible. It’s not nice to be constantly sick for 50 days.”

Barriers and enablers to oral iron supplementation in pregnancy were explored in this study.

Gastro-intestinal side-effects featured heavily in the interview transcripts and appeared to contribute to poor compliance with oral iron supplementation in pregnancy. Forgetfulness also negatively impacted compliance.

One participant commented that the cost of a more expensive brand of iron supplementation influenced compliance. A prior experience

HEARTBURN?

Famotidine, Magnesium Hydroxide, Calcium Carbonate.

WORKS IN 3 Neutralises existing acid 3 Reduces acid production 2 MINUTES AND LASTS 3 Effective relief in just one dose FOR UP TO 12 HOURS 3 Lasts all day or night PEPCID DUO HAS THE BENEFIT OF ANTACIDS AND A H2 BLOCKER

ANTACIDS

Calcium Carbonate and magnesium hydroxide neutralises the exisiting acid in the stomach.

H2 BLOCKER

Famotidine actively reduces the amount of acid produced.

Pepcid Duo Chewable Tablets Composition: Each chewable tablet contains: Famotidine 10.0 mg, Magnesium hydroxide 165.00 mg, Calcium carbonate 800.00 mg. Pharmaceutical form: Chewable tablet. Indications: Pepcid Duo is indicated in short-term symptomatic treatment of heartburn and acid regurgitations in adults and adolescents 16 years & over. Dosage: FOR ADULTS AND ADOLESCENTS (16 years & over): Chew one tablet thoroughly when symptoms occur, and swallow preferably with a glass of water. Do not exceed 2 tablets per day. Treatment duration is limited to 2 weeks (see section 4.4 Special warnings and Precautions for use). Paediatric population: The safety and efficacy of Pepcid Duo in children under 16 years of age has not yet been established (no data are available). Elderly: No dosage adjustment is required for the elderly. Renal Impairment: This medicine is contraindicated in patients with severe renal failure. Patients with renal impairment should consult their physician before taking famotidine/antacid combination. Hepatic Impairment: No dosage adjustment is required for famotidine/antacid combination in hepatic impairment. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Severe renal failure. Cross sensitivity in H2receptor antagnonists has been observed. Famotidine/antacid combination should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists. Special warnings and precautions for use. Warnings: Patients should consult a physician or pharmacist before use with any other medication.

Antacids may interact with certain medications. Patients with renal or hepatic impairment should consult a physician before using Pepcid Duo Chewable Tablets. In case of renal failure, monitoring of serum magnesium and calcium should be undertaken. Pepcid Duo is contraindicated in patients with severe renal failure. As some serious underlying conditions can have symptoms in common with simple indigestion, it is recommended patients seek medical advice in case of: indigestion symptoms accompanied by unintentional weight loss, difficulty swallowing, persistent abdominal discomfort, heartburn occurring for the first time or if these symptoms have recently changed. Patients with pre-existing known hypercalcaemia, hypermagnesaemia, hypophosphataemia, hypercalcuria, a history of renal calculi or nephrocalcinosis should consult a physician before using famotidine/antacid combination. As this product contains lactose, glucose and benzyl alcohol: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients with rare glucose-galactose malabsorption should not take this medicine. This medicine contains 0.000238 mg benzyl alcohol in each tablet which is equivalent to 0.000129 mg/g. Benzyl alcohol may cause allergic reactions. High volumes of benzyl alcohol should be used with caution and only if necessary, especially in subjects pregnant or breastfeeding, or with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis). With long term use, especially during concomitant treatment with other calcium products and/or Vitamin D products, there is a risk of hypercalcaemia with subsequent kidney function impairment. Patients should stop use and consult a physician if new symptoms develop or if they experience dysphagia (difficulty swallowing) odynophagia (pain on swallowing), sever vomiting, melaena (black stools), choking or chest pain. Precautions for use: If symptoms persist after 2 weeks of continuous treatment or get worse, an etiologic survey must be done and the conduct of the treatment should be re-evaluated. Undesirable effects: Immune system disorders Not known Hypersensitivity, Anaphylactic reaction. Nervous system disorders Common Headache Uncommon Nervousness, Paresthesia, Dizziness Not known Somnolence. Gastrointestinal disorders Uncommon Abdominal discomfort and pain Abdominal distension Nausea Diarrhoea Flatulence Dyspepsia Eructation Dysgeusia Oropharyngeal discomfort and pain Dry mouth, thirst Vomiting Not known Abdominal pain upper. Skin and subcutaneous tissue disorders Not known Pruritus Rash Urticaria Angioedema. General disorders and administration site conditions Not known Asthenia, fatigue. Other side effects noted in isolated reports with higher dosages of famotidine in principle cannot be excluded. There have been very rare reports of: Cutaneous: as with other H2 antagonists, severe skin reactions (toxic epidermal necrolysis). Hypersensitivity reactions: bronchospasm. Hepatic disorders including hepatic cholestasis and such as raised laboratory values for transaminases, gamma-GT, alkaline phosphatase and bilirubin. Neurological disorders such as hallucinations: disorientation, confusion and insomnia, epileptic seizures, drowsiness and agitation and depression related states. These have been reported to be reversible on stopping medication. Blood disorders such as thrombocytopenia, leucopenia, agranulocytosis and pancytopenia. Musculoskeletal disorders, such as muscle cramps. Others such as impotence, reduced libido, breast tension. Alopecia Malaise. The following side effects are generally attributed to antacids containing calcium and magnesium salts: change in stool frequency and consistence, bloating and fullness. MAH: JNTL Consumer Health I (Ireland) Ltd, Block 5, High Street, Tallaght, Dublin 24, Ireland. MA Number: PA23490/027/001. Date of revision: March 2024. Product not subject to medical prescription. Supply through pharmacies only. Full prescribing information available upon request from JNTL Consumer Health I (Ireland) Ltd. IE-PE-2400001

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Supplementation

of poorly tolerating oral iron in the past also caused hesitation with compliance.

Factors that positively affected compliance included a noticeable or anticipated improvement in fatigue with oral iron supplementation. The benefit of a routine with ingestion of oral iron was also cited as an aid in terms of assisting compliance. A fear of worsening symptoms of anaemia and a desire to avoid the risks of a blood transfusion were other factors which appeared to motivate compliance with oral iron therapy. There was also evidence that reduced dose frequency positively impacted compliance with oral iron supplementation.

Pregnancy as motivating factor recurred as a theme in analysis of the interviews. Participants felt that most women were highly motivated to do everything in their power for the best possible outcome for themselves and their baby. This effect was described as greater than any motivation for compliance with treatment outside of pregnancy.

P6- “I presume, like most women, when they’re pregnant, you just want to do the best thing for your health and the baby’s health. In more normal times… I probably wouldn’t have been as compliant, but I think being pregnant, you just want to look after yourself and the baby. So that was definitely a motivating factor.”

P2- “I didn’t object to taking them because you do take whatever you need to take. You know, whatever they tell you. They tell you; you need coal. You’re going to take the coal. Your motivation is high in pregnancy.”

In terms of the role of diet in the management of iron deficiency anaemia in pregnancy, participants’ knowledge and awareness of iron-rich foods was generally good. There also was evidence that women believed and understood that diet alone would not rectify their anaemia: P4- “For me, dietary stuff was ineffective. I’d go for all the ironrich foods, and it was just neglible.

It was just the impact was too tiny for the mountain I was trying to climb.”

Pregnancy symptoms and nausea negatively impacted appetite for some women. For some, they felt a reliance on supplementation due to this. Knowledge of facilitators and inhibitors of iron absorption was also widely good.

Themes that emerged in relation to trial acceptability included the benefit and attraction of extra supportive care in pregnancy and

the time constraints women can be under. Participants highlighted the demands on women’s time and to try to work around this for convenience for any trial participants. Pregnancy alone requires planning for regular and frequent appointments in women who have busy lives and would not otherwise require planning for regular medical appointments outside of pregnancy.

The proposed trial generally received very positive feedback with participants feeling that this was an important area of research: P1- “I think this trial is very important and it sounds like it’s going to be very educational for women in the longer term.”

P5- “I think it’s a very interesting study. So very, very much needed… I’m happy you are working on it” P6- “There doesn’t seem to be a particularly large burden on the participants, and I think that it would be largely acceptable.”

There were mixed responses to the acceptability of taking alternate day versus daily iron.

Some women felt alternate day iron would be acceptable and potentially beneficial for that arm of the trial. However, there was doubt among some participants about the willingness of patients to accept alternate day iron over daily iron.

Main findings Themes of awareness, compliance, the role of diet and pregnancy as a motivating factor recurred throughout our analysis. Fatigue emerged as the predominant and most troubling symptom.

Knowledge and awareness of possible adverse consequences of iron deficiency anaemia in pregnancy were poor. Significant unpleasant gastro-intestinal side-effects appeared to be experienced widely among interviewees and affected compliance. Factors that positively impacted compliance with oral iron supplementation included routine, a perceived or historical improvement in symptoms with supplementation, reduced dose frequency and a desire to avoid both worsening symptoms of anaemia and a blood transfusion.

Clinical significance Awareness pre-pregnancy of iron deficiency anaemia varied in our cohort. When present, it stemmed from personal experience of friends and family and anecdotal advice. However, knowledge on symptoms and the potential need for iron supplementation in pregnancy was generally

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good. First pregnancy also appeared to be a time when women noticed an emphasis from health professionals on the problem. This may possibly be explained by health providers assuming prior knowledge from previous pregnancies in multiparous women. Participants knowledge on both iron-rich diets and foodstuff that could impact iron absorption was also good. This may be due to the population in our catchment area being generally well-educated, from a higher socio-economic background and the mean age of our participants being 36. The appreciation that an iron-rich diet alone was not sufficient to rectify anaemia in pregnancy appeared to stem from personal experience of increasing dietary iron with no noticeable improvement in symptoms: P4- “For me, dietary stuff was ineffective. I’d go for all the iron-rich foods, and it was just neglible. It was just the impact was too tiny for the mountain I was trying to climb.”

Knowledge on the possible negative sequelae of untreated iron deficiency anaemia in pregnancy however was poor. None of our participants commented on the potential for maternal complications or the negative associations including preterm birth, low-birth weight, Caesarean delivery, post-partum haemorrhage. Knowledge surrounding possible adverse outcomes for the foetus in the short and long-term were also poor. Only one participant commented on the effect maternal iron deficiency anaemia might have on the baby’s iron stores in the 6 months post-delivery.

Fatigue emerged as a pervasive and debilitating symptom women experienced with iron deficiency anaemia in pregnancy.

The effects were dramatic and appeared worse than previously experienced tiredness. Significant fatigue is known to affect quality of life and increase the likelihood of depressive symptoms in pregnancy. Undetected and untreated antenatal depression is one of the strongest risk factors for postnatal depression.

The feedback on trial acceptability from our study was used to inform our design for a planned randomized controlled trial of daily versus alternate day oral iron in pregnancy. Acceptability refers to determining how well an intervention will be received by the target population and the extent to which the new intervention or its components might meet the needs of the target population and organizational setting.

It has become a key consideration in the design, evaluation and implementation of clinical trials.

Positive feedback noted from this qualitative study included the benefit of extra supportive care in pregnancy and the potential to improve side-effects of oral iron for women in pregnancy.

Perceived research relevance has been shown to be an important factor for clinical trial recruitment in pregnancy.

Advice on incorporating research visits with routine antenatal care and limiting extra hospital visits was used to finalise our trial protocol. Time constraints on women has been shown to be a factor affecting both recruitment and retention in clinical research trials in pregnancy.

It is useful to be aware that some participants may resist or refuse their randomized dosing regimen.

Participants’ understanding that a scientific question is being answered and the nature of participation will need to be ensured prior to recruitment.

Randomised trials in pregnancy face specific enrolment challenges and research in pregnancy can be limited due to an individual’s risk perception.

Altruism and a wish to contribute to scientific research has been shown to be a previous motivating factor in trial participation in pregnancy. However, key motives which have previously been identified for non-participation in clinical trials in pregnancy include a dislike for the intervention, either because of a risk of harm or due to practical considerations.

Future research Further qualitative research in this area could focus on a younger cohort and populations from lower socio-economic groups but who are still residing and receiving antenatal care in a higher income country. Purposive sampling from ethnicities more strongly affected by iron deficiency anaemia would also be of interest to ascertain if the same themes recur and if there are any cultural differences in the analyses.

Conclusion In conclusion, women view sideeffects as a significant barrier to taking oral iron. Informing women on the important maternal and infant complications associated with iron deficiency may prove to improve compliance with oral iron treatment. Women clearly view this topic as an important research area.

News

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Improving Assessment of MS RCSI has partnered with Dublin-based Head Diagnostics on a clinical study to enhance the assessment and monitoring of multiple sclerosis (MS) through innovative technology. The study, launched to coincide with World MS Day, will explore the use of novel digital biomarkers to monitor disease, with the aim of providing greater objectivity in assessing the condition.

MS is a complex neurological disorder that affects millions of people worldwide. The current methods of assessing disease progression and treatment effect for MS patients are limited and often subjective. This new collaboration aims to address this issue by exploring the potential of non-invasive digital biomarkers, including a little-known tremor of the eye and measures of a person’s manner of walking, to provide accurate and real-time data on disease activity.

Central to the study is Head Diagnostics' innovative iTremor One device, a handheld medical device that gives a rapid and non-invasive measure of ocular microtremor (OMT), a high-frequency involuntary fixational eye movement that is believed to reflect activity in the brainstem. Previous studies have found that OMT changes in people with MS, as well as other neurological conditions, although the traditional approach to measuring this has been particularly invasive, limiting research.

Combining this measure with gait analysis offers the potential to provide more comprehensive, accurate and real-time data on disease activity.

This observational study based in Beaumont Hospital is designed to evaluate the utility of OMT and gait

This new clinical study will enhance the assessment and monitoring of multiple sclerosis in monitoring MS, enrolling 120 participants including those with and without a diagnosis of MS, and assessing them regularly over a 12-month period.

New direction “Exploring the potential of measuring patients’ microtremors of the eye and their gait as measures of MS progression offers a promising new direction in our management approach,” said Dr Lisa Costelloe, Honorary Clinical Senior Lecturer at RCSI, Consultant Neurologist at Beaumont Hospital, and study coprincipal investigator.

“The treatment options for MS patients have advanced dramatically in recent decades but the outcome measures we use in clinical practice do not capture all aspects of the disease, in particular early disease progression. This study marks a significant step in exploration of more precise and robust monitoring of MS, which is crucial for effective management and treatment.”

RCSI’s School of Pharmacy and Biomolecular Sciences and study co-principal investigator, noted the importance of this research, saying: “This study presents a unique opportunity to develop digital measures that can provide a more convenient, comprehensive, and objective measure of MS. By leveraging digital health technologies, we seek to support assessment, enhance disease monitoring, and contribute to the advancement of precision medicine in MS.”

Dr Rob Argent, Lecturer in Digital and Connected Health in

“In combining our innovative iTremor One device with RCSI's

research expertise, we aim to revolutionise the way MS is assessed and monitored,” said David van Zuydam, Head Diagnostics’ CEO. “This study supports our mission to provide objective and real-time disease management tools for neurological diseases and impairments.”

This study is supported by the Enterprise Ireland Innovation Partnership Programme, which provides funding and support for collaborative research projects between industry and academic institutions in Ireland.

HIQA launches public consultation on Enhanced Flu Vaccines The Health Information and Quality Authority (HIQA) has launched a public consultation on its draft health technology assessment (HTA) on the use of an enhanced inactivated influenza (flu) vaccine in those aged 65 years and older, as part of the HSE’s Seasonal Influenza Vaccination Programme.

HIQA agreed to undertake this assessment at the request of the Department of Health to inform the Minister for Health’s decision on whether enhanced flu vaccines should be funded by the HSE for those aged 65 years and older.

Dr Máirín Ryan, HIQA’s Deputy CEO and Director of Health Technology Assessment, said: “Sometimes vaccine effectiveness can be suboptimal due to a mismatch between the content of the vaccine and the flu strains circulating that year. Vaccine effectiveness may also be reduced due to an ageing or compromised immune system.”

“Enhanced flu vaccines have been developed in an attempt to increase vaccine effectiveness.”

In Ireland, people aged 65 years and older can already receive the flu vaccine free of charge through the HSE Seasonal Influenza Vaccination Programme.

Currently, a standard flu vaccine is used for this age group, with uptake of almost 77% among those aged 65 and older in the 2022-2023 flu season. Despite this, Irish data demonstrate that those aged 65 years and older are disproportionately affected by influenza, both in terms of morbidity and mortality, and that influenza can place a substantial

burden on healthcare services every winter. In the 2022-2023 flu season, there were over 1,700 admissions to hospital for flu in this age group.

HIQA found that enhanced flu vaccines are safe and that a number of these vaccines are potentially more effective than standard vaccines. It also found that offering an enhanced vaccine, in place of a standard one, to those aged 65 years and older would be a good use of HSE resources. However, this finding was highly sensitive to the cost of the vaccines, making this a key consideration in any decision to fund enhanced flu vaccines

and in price negotiations with vaccine manufacturers.

HIQA has now published its draft findings and wants to get feedback from the public on the draft report. An online survey and details of how to take part in the consultation are available on HIQA’s website, including a form that can be posted to HIQA. The deadline for submissions is 5pm on 11 July 2024.

Following the public consultation, the report will be finalised and submitted as advice to the Minister for Health, and published on the HIQA website.

Read the draft report and take part in the consultation at www.hiqa.ie.

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News

New Survey shows Alarming Asthma Concerns An estimated 450,000 people in Ireland have asthma and, according to a recent patient survey, concerning numbers are experiencing persistent symptoms that may indicate their asthma is uncontrolled. In response, this World Asthma Day, the Asthma Society of Ireland is launching a campaign to empower people with asthma to recognise the signs and symptoms of uncontrolled asthma and when to seek medical help.

Professor Marcus Butler

reduce the risk of exacerbations, and improve their overall quality of life.

The Asthma Society is also joining the global call on healthcare professionals, led by the Global Initiative for Asthma (GINA), to increase their awareness of the continuing avoidable morbidity and mortality from asthma. According to CSO figures, 81 asthma deaths were registered in 2022. The majority of asthma deaths are believed to be preventable. By following up-to-date guidelines and published evidence on effective asthma management, healthcare professionals will ensure that they are equipped to provide reliable information and optimal treatment for their patients.

• Almost one-quarter (24%) of adults and children have used their reliever/rescue inhaler at least once daily.

Despite significant advances in asthma care over recent years, key challenges persist. These include missed or mis-diagnoses, underuse of anti-inflammatory inhaled corticosteroid inhalers, over-reliance on short-acting beta2–agonist (SABA) inhalers and oral corticosteroids, and poor recognition of patients requiring specialist assessment and further management.

If left untreated, uncontrolled asthma can lead to decreased quality of life, asthma attacks, and even fatalities. Recognising the urgent need for action, the Asthma Society of Ireland encourages individuals to speak to their healthcare provider for an initial or updated assessment and urges healthcare professionals to reexamine their treatment protocols for patients.

In a recent Asthma Society survey of 1,205 asthma patients and their carers,

In addition to providing helpful educational resources for patients, the campaign will highlight the importance of implementing a personalised asthma action plan under the guidance of a GP and working closely with their primary healthcare physician to develop comprehensive strategies to control their asthma symptoms,

• Over half (51%) of those surveyed reported that they or their child had had an asthma attack in the last year, and nearly one quarter (24%) had an attack in the previous month.

• 43% of people surveyed had taken steroid tablets at least twice in the past year, with onefifth (20%) having taken them more than three times.

• 74% said they or their child’s sleep had been disturbed by asthma in the past year.

The survey also found that almost a quarter (24%) of respondents felt that healthcare providers did not take asthma seriously.

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The Asthma Society of Ireland also provides a range of free self-management education services and resources to help people manage their asthma in between consultations with healthcare providers, which can be accessed via asthma.ie. There is also an e-referral system in place for healthcare professionals to refer their patients to the Asthma Society’s free nurse-led Adviceline and WhatsApp messaging service.

"Knowledge is power when it comes to managing asthma effectively," said Eilis Ní Chaithnía, CEO of the Asthma Society of Ireland. “Our campaign is supporting people to recognise the signs and symptoms of uncontrolled asthma and when to seek medical help. Worryingly, however, according to our recent patient survey, almost a quarter (24%) of the 1,205 respondents say that healthcare providers do not take asthma seriously.

Asthma is a complex disease that can be challenging to manage effectively. Patients need confidence in their diagnosis, treatment and their healthcare professional. While patient education and professional education in asthma are time consuming in an already overburdened healthcare service, they are integral to achieving optimal quality of life and health outcomes.”

Professor Marcus Butler, Consultant Respiratory Physician at St Vincent's Hospital and Medical Director of the Asthma Society, highlights the role of healthcare professionals in supporting self-management saying, “Our findings released

today indicate a high prevalence of potentially uncontrolled asthma in the Irish asthma population. Asthma is a chronic condition, but there is no room for complacency—managing asthma requires a combined effort, and we, as healthcare professionals, have an important role to play.

This is why education by and for healthcare professionals is crucial—we need to keep up to date with the latest clinical guidelines and ensure our patients have the required support, information, and treatment.”

Professor Butler continued, “Adherence to asthma medications is only about 30%. This is due to a number of factors including cost and a lack of education about their uses, correct mode of delivery and potential side effects. Up-to-date knowledge of the various asthma treatments is crucial for healthcare professionals and patients to support shared decision making.”

“Through our regular webinars featuring expert speakers, our asthma management resources, and our free nurse-led patient services, the Asthma Society empowers patients, carers and healthcare professionals through education. All of its supports and services are governed by its Medical Advisory Group, of which I am a member. I’d recommend referring asthma patients to these services via our e-referral system for self-management support between consultations.”

The Medicines Management Programme (MMP) recommends Lonquex® (Lipegfilgrastim) as a Best-Value Biological (BVB) Medicine for the long-acting granulocyte-colony stimulating factors on the High Tech Arrangement.

Prescribing Lonquex® will lead to significant savings for the health service.

Lonquex

® ,c® 6 r119

6 mg solution for injection pre-filled syringe

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(Lipegfilgrastim) Indications • Lonquex is indicated in adults for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndrome).

Further information available from the SmPC available at HPRA.ie Lonquex® (lipegfilgrastim) Information

6mg solution

for injection Abbreviated

Prescribing

Presentation: Lipegfilgrastim 6mg solution for injection in 0.6ml pre-filled syringe.

Indications: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Dosage and administration: Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology. Adults and Children 2 years and older (weighing� 45kg): 6mg of Lonquex for each chemotherapy cycle, approximately 24 hours after cytotoxic chemotherapy. Elderly: No relevant age-related difference with regards to safety or efficacy. Impaired renaVhepatic function: The pharmacokinetic profile is not expected to be affected. However, no recommendation on a posology can be made. Children less than 2 years: No data available. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions and warnings: Not to be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens. Patients hypersensitive to G-CSF or derivatives are at risk of hypersensitivity reactions to lipegfilgrastim. Regular monitoring of the platelet count and haematocrit is recommended since lipegfilgrastim does not preclude thrombocytopenia and anaemia caused by myelosuppressive chemotherapy. Leukocytosis may occur; therefore a white blood cell count should be performed at regular intervals during therapy owing to the clinical effects of lipegfilgrastim and the potential for leukocytosis. Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings. Not to be used in patients with chronic myeloid leukaemia, myelodysplastic syndromes or secondary acute myeloid leukaemia. Spleen size should be carefully monitored since frequent asymptomatic cases of splenomegaly and infrequent cases of splenic rupture, including fatal cases, have been reported. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk of pulmonary adverse reactions. Physicians should exercise caution when administering Lonquex in patients with sickle cell anaemia, since sickle cell crisis has been associated with the use of G-CSF in these types of patients. Hypokalaemia may occur; therefore serum K+ levels should be carefully monitored and K+ substituted if necessary, in patients at risk of hypokalaemia. Not to be used in patients with rare hereditary problems of fructose intolerance since Lonquex contains sorbitol. During post-marketing, capillary leak syndrome has been reported after administration of G CSF or derivatives and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients who develop symptoms of

Teva Pharmaceuticals Ireland, Digital Office Centre Swords, Suite 101 - 103, Balheary Demesne, Balheary Road, Swords, Co Dublin, K67ESAO, Ireland.

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

Prescription Only Medicine.

capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care. This has generally occurred in patients suffering advanced malignant disease, having sepsis, taking multiple chemotherapy medications or undergoing apheresis. Glomerulonephritis has been reported in patients receiving filgrastim, lenograstim or pegfilgrastim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim, lenograstim and or pegfilgrastim. Urinalysis monitoring is recommended. Interactions: Concomitant use of lipegfilgrastim with any chemotherapeutic medicinal product has not been evaluated in patients. In animal models, concomitant administration of G-CSF and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression. The safety and efficacy of Lonquex in patients receiving chemotherapy for delayed myelosuppression has not been evaluated. The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated. Pregnancy and lactation: Not recommended in pregnancy or whilst breastfeeding. No data available with regards to fertility. Effects on ability to drive and use machines: No or negligible influence on the ability to drive and use machines. Adverse reactions: Serious: Leukocytosis, hypersensitivity reactions, pulmonary adverse reactions including haemorrhage, glomerulonephritis.

Capillary leak syndrome, which can be life-threatening, has been reported in post-marketing experience and aortitis. Very common: Musculoskeletal pain, nausea.

Common: Thrombocytopenia, hypokalaemia, headache, skin reactions, chest pain, haemoptysis. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: In the case of overdose, white blood cell and platelet counts should be performed regularly, and spleen size should be carefully monitored. Legal Category: POM. Marketing Authorisation Number: EU/1/13/856/001-002. Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands. Job Code: MED-IE-00061. Date of Preparation: August 2022.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com Date of Preparation: May 2024 Job Code: LQX-IE-00006

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

te a

T E G R O F E T ’ H T N O K C D S A L P A I O T T N E S ES

Date of preparation: (04-24) CCF: 26475

The end of erectile problems?

Touch wood.

Sidena. Your new firm favourite.

Sidena 50mg Tablets are now available over the counter in a 4 and 8 pack.

ABBREVIATED PRESCRIBING INFORMATION Product Name: Sidena 50 mg Tablets.

Composition: Each tablet contains, 50 mg sildenafil (as citrate) .

Description: Light blue, round, slightly dotted tablets. Cross breaking notch on one side and marked ‘50’ on the other side. Can be divided into equal quarters. (Only two quarters of the 50 mg is covered by posology).

Indication(s): Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

Dosage: Adults and elderly: 50 mg taken as needed approximately one hour before sexual activity. Dose may be decreased to 25 mg. Max dose: 50mg once daily. Impaired renal and hepatic function: Sildenafil clearance is reduced in hepatic and severe renal impairment. Consider a dose of 25 mg. Dose may be increased step-wise to 50 mg if tolerated. Children and adolescents below 18 years of age: Contraindicated. Use in patients using other medicines: Starting dose of 25 mg with CYP3A4 inhibitors (not advised to use with ritonavir). To minimise postural hypotension in patients receiving and alpha-blocker, stabilise patient first on the alpha blocker and use a starting dose of 25 mg sildenafil.

Contraindications: Hypersensitivity to sildenafil or any of the excipients. Concomitant with ritonavir, nitric oxide donors or nitrates in any form, guanylate cyclase stimulators e.g. riociguat. In patients that sexual activity is inadvisable (e.g. severe cardiovascular disorders such as a recent (6 months) acute myocardial infarction (AMI) or stroke, unstable angina or severe cardiac failure). Refer these patients to a doctor. Patients with loss of vision in one eye due to NAION. Known hereditary degenerative retinal disorders. Severe hepatic impairment.

Hypotension. Anatomical deformation of the penis. Women. Not intended if no erectile dysfunction.

Warnings and Precautions for Use: First diagnose erectile dysfunction and determine potential underlying causes (e.g. hypertension, diabetes mellitus, hypercholesterolaemia or cardiovascular disease), before considering pharmacological treatment. Consider the cardiovascular status of patients, since there is a degree of cardiac risk associated with sexual activity. Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of sildenafil. Most, but not all, of these patients had pre-existing cardiovascular risk factors. Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure. Caution: Patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). Advise patients that in case of priapism, prolonged erections (longer than 4 hours) or sudden visual defect, they should stop taking sildenafil and consult a physician immediately. Administer to patients with bleeding disorders or active peptic ulceration only after careful benefit-risk assessment, as there is no safety information available.

Interactions: Inhibitors of the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route) isoenzymes such as CYP3A4 inhibitors: Itraconazole, ketoconazole, erythromycin, cimetidine, HIV protease inhibitor saquinavir: May reduce sildenafil clearance and increase sildenafil plasma levels. Consider a starting dose of 25 mg. Strong CYP3A4 inducers e.g. rifampicin may increase sildenafil clearance and decrease sildenafil plasma concentrations. Grapefruit juice: May give rise to modest increases in plasma levels of sildenafil. Nicorandil (Hybrid of potassium channel activator and nitrate): Due to the nitrate component it has the potential to have serious interaction with sildenafil. Sildenafil potentiates the hypotensive effect of nitrates. Alpha blocker: Concomitant administration of sildenafil may lead to symptomatic hypotension in a few susceptible individuals. Patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Not recommended in patients with a history of bleeding disorders or active peptic ulceration. Not recommended to use with other pulmonary arterial hypertension treatment containing sildenafil.

Ability to Drive and Use Machinery: Minor influence, dizziness and altered vision were reported. Patients should be aware of how they react to sildenafil before driving or using machinery. Undesirable Effects: Very common: Headache. Common: Dizziness, visual disorders, visual colour distortion, vision blurred, flushing, hot flush, nasal congestion, nausea, dyspepsia. See SPC for more adverse effects.

Marketing Authorisation Holder: Rowex Ltd, Bantry, Co. Cork. Marketing Authorisation Number: PA 0711/170/002. 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 Adverse events should be reported. Reporting forms and information can be found on the Legal Category: Not subject to medical prescription.

HPRA website (www.hpra.ie) or by emailing Rowex pv@rowa-pharma.ie Date of Preparation: Aug 2022

Supply status: Supply through pharmacies only.

Topic Team Training – Erectile Dysfunction 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. penile arteries, nerves, hormone levels, smooth muscle tissue, corporal endothelium, or tunica albuginea. It is closely related to cardiovascular disease, diabetes mellitus, hyperlipidaemia, hypertension, and endothelial dysfunction.

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 Erectile Dysfunction.

Erectile dysfunction (ED) is a common condition occurring in males over 40 years of age, although it can occur earlier. It is estimated that at least 150 million men globally have ED. It is difficult to obtain accurate values for the true prevalence of erectile dysfunction however, as many patients fail to seek medical attention, and many clinicians are reluctant to ask patients about their sexual health.

Erectile dysfunction is the inability to achieve or maintain an erection for satisfactory sexual performance, and affects a considerable proportion of men at least occasionally. It is often

treatable, however, if left untreated, ED can be a source of severe emotional stress for both the man and their partner.

Although most men will experience periodic episodes of erectile dysfunction, it tends to become more frequent with advancing age.

Many factors can contribute to sexual dysfunction in older men, including physical and psychological conditions, comorbidities and polypharmacy.

Aspects of an ageing man’s lifestyle behaviour and androgen deficiency, most often decreasing testosterone levels, can affect sexual function.

While ED is associated with ageing, many studies and largescale surveys have concluded that ED is a major health concern among young men.

The condition can be caused by any disease process which affects

Consider:

Besides cardiovascular disease, there are strong correlations between ED and hyperlipidaemia, diabetes, hypogonadism, obesity, smoking, alcoholism, benign prostatic hyperplasia (BPH) with lower urinary symptoms (LUTS), depression, and premature ejaculation. Diabetes is a common aetiology of sexual dysfunction, because it can affect both the blood vessels and the nerves that supply the penis. Men with diabetes are four times more likely to experience erectile dysfunction, and on average, experience it 15 years earlier than men without diabetes.

A thorough medical history, detailed sexual history, and physical examination are required before commencing treatment or further investigations. It is important to distinguish between psychological and organic causes of ED, as well as to ensure that the patient has erectile dysfunction and not another disorder. History that points towards a psychological aetiology include, sudden onset of erectile dysfunction especially if it is related to a new partner or a major life-changing event, situational ED, normal erections with masturbation or a different partner, presence of morning erections and high daily variability in erectile rigidity.

Numerous medications are listed with erectile dysfunction and/ or a decreased libido as a side effect.

Drugs that can cause ED include hydrochlorothiazide’s and betablocking agents. Medications used to treat depression, particularly the SSRIs such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline, can also contribute to ED. The severity of erectile dysfunction is often described as mild, moderate or severe according to the five-item International Index of Erectile Function (IIEF-5) questionnaire,

A complete medication list including supplements should be checked with the patient. ED can be a result of prescription or other medications. Prescription drugs that can cause ED include, antidepressants especially SSRIs, cimetidine, ketoconazole, spironolactone, sympathetic blockers, thiazide diuretics, and other antihypertensives. ACE inhibitors and calcium channel blockers are the least likely to cause ED. Beta-blockers are only a minor contributor, while alpha-blockers can improve erectile function.

Key Points:

Actions:

 Erectile dysfunction is the inability to achieve or maintain an erection for satisfactory sexual performance

Ensure support staff understand the following key points:

 The importance of asking questions to enquire about medication and supplement use is important as ED can sometimes be the result of prescription or other medicines

 Does my pharmacy team have a general understanding of erectile dysfunction?

 Common causes and signs/symptoms of Erectile Dysfunction

 Is the team aware and familiar with the common causes of this condition?

 The importance of lifestyle factors

 Do we make the most of the potential for linked sales?  Am I up to date with the latest guidance?

 Types of medications available to treat the condition

 Is the team aware of the lifestyle measures that may help?

 When to refer.

92 | PHARMACYNEWSIRELAND.COM

with a score of 1–7 indicating severe, 8–11 moderate, 12–16 mild–moderate, 17–21 mild and 22–25 no erectile dysfunction.

 Those who will typically present with to the pharmacy with Erectile Dysfunction  The key symptoms of Erectile Dysfunction  The benefits and limitations of OTC medicine  The importance of what outcome a patient presenting with Erectile Dysfunction wants  Lifestyle issues that may impact on Erectile Dysfunction  When to refer customers to the pharmacist

Legal Category: Not subject to medical prescription. Supply through pharmacies only. Marketing Authorisation Number: PA23055/016/001 Marketing Authorisation Holder: Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands. Full prescribing information available on request from: Viatris, Dublin 17. Phone 01 8322250 Date of Revision of Abbreviated Prescribing Information: 01 Feb 2024 Reference Number: IE-AbPI-ViagraConnect-v004

Helps you

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Reporting of adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie. Adverse reactions/events should also be reported to the marketing autorisation holder at the email address: pv.ireland@viatris.com or phone 0044(0)8001218267.

tablets

50 mg

LITT

Indications, Dosage and Administration: Indications: For erectile dysfunction in adult men. Dosage and Method of use: Adults: one 50 mg tablet taken with water approx. one hour before sexual activity. The maximum dosing frequency is once per day. The onset of activity may be delayed if taken with food. Patients should be advised that they may need to take Viagra Connect a number of times on different occasions (max of one 50 mg tablet per day), before they can achieve a penile erection satisfactory for sexual activity. If patients are still not able to achieve a sufficient penile erection they should be advised to consult a doctor. Elderly: no dosage adjustments required (≥ 65 years old).

Renal Impairment: No dosage adjustments for patients with mild to moderate renal impairment.

Dosage adjustments required for those with severe renal impairment, see SmPC. Hepatic Impairment: Dosage adjustments required for those with mild-moderate hepatic impairment, see SmPC. Viagra Connect is contraindicated for patients with severe hepatic impairment (see contraindications). Presentation: Film-coated tablets containing sildenafil citrate equivalent to 50 mg of sildenafil. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Co-administration with nitric oxide donors (such as amyl nitrite), nitrates, ritonavir, guanylate cyclase stimulators (such as riociguat) is contraindicated. Agents for the treatment of erectile dysfunction, including sildenafil, should not be used by those men for whom sexual activity may be inadvisable, and these patients should be referred to their doctor. This includes patients with severe cardiovascular disorders such as a recent (6 months) acute myocardial infarction (AMI) or stroke, unstable angina or severe cardiac failure. Sildenafil should not be used in patients with severe hepatic impairment, hypotension (blood pressure < 90/50 mmHg) and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases). Sildenafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure. Viagra Connect should not be used in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease). Viagra Connect is not indicated for use by women. The product is not intended for men without erectile dysfunction. This product is not intended for men under 18 years of age. Warnings and precautions: Erectile dysfunction can be associated with a number of contributing conditions, e.g. hypertension, diabetes mellitus, hypercholesterolaemia or cardiovascular disease. As a result, all men with erectile dysfunction should be advised to consult their doctor within 6 months for a clinical review of potential underlying conditions and risk factors associated with erectile dysfunction (ED). If symptoms of ED have not improved after taking Viagra Connect on several consecutive occasions, or if their erectile dysfunction worsens, the patient should be advised to consult their doctor. Cardiovascular risk factors: Since there is a degree of cardiac risk associated with sexual activity, the cardiovascular status of men should be considered prior to initiation of therapy. Agents for the treatment of erectile dysfunction, including sildenafil, are not recommended to be used by those men who with light or moderate physical activity, such as walking briskly for 20 minutes or climbing 2 flights of stairs, feel very breathless or experience chest pain. For a list of patients who are considered at low cardiovascular risk from sexual activity see SmPC. Patients previously diagnosed with the following must be advised to consult with their doctor before resuming sexual activity: uncontrolled hypertension, moderate to severe valvular disease, left ventricular dysfunction, hypertrophic obstructive and other cardiomyopathies, or significant arrhythmias.

Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure.

Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g. aortic stenosis), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure. Priapism: Patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia), should consult a doctor before using agents for the treatment of erectile dysfunction, including sildenafil. Prolonged erections and priapism have been occasionally reported with sildenafil in post-marketing experience. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. Concomitant use with other treatments for erectile dysfunction is not recommended. Effects on vision: Patients should be advised that in the event of any sudden visual defect, they should stop taking Viagra Connect and consult a physician immediately. Concomitant use with CYP3A4 inhibitors: patients should be advised to consult a doctor before taking Viagra Connect as a 25 mg tablet may be more suitable for them. Concomitant use with alpha-blockers: Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the co-administration may lead to symptomatic hypotension in a few susceptible individuals.

This is most likely to occur within 4 hours post sildenafil dosing. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Thus, patients taking alpha blockers should be advised to consult their doctor before taking Viagra Connect. Treatment should be stopped if symptoms of postural hypotension occur, and patients should seek advice from their doctor on what to do. Effect on bleeding: the use of sildenafil is not recommended in those patients with history of bleeding disorders or active peptic ulceration, and should only be administered after consultation with a doctor. Hepatic impairment: Patients with hepatic or renal impairment must be advised to consult their doctor before taking Viagra Connect, since a 25 mg tablet may be more suitable for them.

Lactose: The film coating of the tablet contains lactose. Viagra Connect should not be administered to men with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet. Patients on low sodium diets can be informed that this medicinal product is essentially ‘sodium-free’. Use with alcohol: Drinking excessive alcohol can temporarily reduce a man's ability to get an erection. Men should be advised not to drink large amounts of alcohol before sexual activity.

Interactions with other medicinal products and other forms of interaction: Individuals receiving concomitant treatment with CYP3A4 inhibitors must be advised to consult their doctor before taking Viagra Connect, dosing adjustments may be required, see SmPC. Patients receiving alpha blocker treatment should be stabilised on therapy prior to initiating sildenafil treatment and must be advised to consult their doctor before taking Viagra Connect as dosing adjustments may be required, see SmPC. Caution when sildenafil is initiated in patients treated with sacubitril/valsartan, see SmPC. Fertility, pregnancy and lactation: There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers. Viagra Connect is not indicated for use by women. Undesirable effects: Very common (≥1/10): headache. Common (>1/100, <1/10): dizziness, visual colour distortions, visual disturbance, vison blurred, flushing, hot flush, nasal congestion, nausea, dyspepsia. For details of uncommon, rare and very rarely reported adverse events and those of unknown frequency, see SmPC.

Viagra Connect (sildenafil) 50 mg film-coated tablets

E

PI

Viagra Connect (sildenafil) 50 mg film-coated tablets Please refer to Summary of Product Characteristics (SmPC) before prescribing

TH

ABBREVIATED PRESCRIBING INFORMATION

BLUE

For more information please contact Viatris or refer to the SmPC for full prescribing information VIAC-2024-0035. DOP: February 2024

www.viagraconnect.ie

Congratulations to all the Winners and Finalists of the 2024 Irish Pharmacy Awards.

Thanks to all of our Sponsors.

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Haleon, formerly part of GSK

Thank You IPN Communications would like to take this opportunity to thank all the companies below who gave their support to the 2024 Irish Pharmacy Awards through the donation of gifts and samples to our Awards Goody Bags and to the raffle prizes in fundraising for Clare’s Wish Foundation.

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Clinical Profiles

IRISH REIMBURSEMENT GRANTED TO PRODUODOPA® (FOSLEVODOPA/ FOSCARBIDOPA) FOR PEOPLE LIVING WITH ADVANCED PARKINSON’S DISEASE AbbVie has announced that the Irish health authorities have approved reimbursement of PRODUODOPA® (foslevodopa/ foscarbidopa) for the treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement) when available combinations of Parkinson medicinal products have not given satisfactory results.

This follows granting of the product authorisation for PRODUODOPA® (foslevodopa/foscarbidopa) in Ireland on 23 September 2022.1 It is a subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations in people living with advanced Parkinson’s disease whose symptoms are inadequately controlled by other therapies.1 The continuous delivery of foslevodopa/foscarbidopa provides levodopa 24-hours a day which may help patients by extending the period when symptoms are well-controlled, often referred to as “On” time.

The VYAFUSER™ pump for the subcutaneous delivery of PRODUODOPA® received Conformité Européenne (CE) Mark in November 2023.

Parkinson’s disease is a chronic, progressive neurodegenerative disorder affecting approximately 6.1 million people globally.

Parkinson’s disease is characterised by tremor, muscle rigidity, slowness of movement and difficulty with balance. As the disease progresses, the severity of symptoms increases , and patients tend to experience greater disability and an impaired ability to perform activities of daily living , as well as the reemergence of symptoms as standard treatment wears off. Characteristics of advanced Parkinson’s disease may include needing help with performing daily activities, increased motor fluctuations (changes in the ability to move referred to as “On-Off” times), difficulty swallowing, recurrent falls, dementia, dyskinesia (involuntary movements) and other symptoms.5 “People living with Parkinson’s disease experience daily challenges and uncertainty, especially as their disease progresses and symptoms are no longer adequately controlled” said Andres Rodrigo, General Manager of AbbVie in

Ireland.7,8, 9,10 “I welcome the availability of foslevodopa/ foscarbidopa for the therapeutic management of Parkinson’s disease in indicated patients.”

Federico Martinon Torres Head of Pediatrics, Hospital Clínico Universitario Santiago, Spain and principal investigator of NIRSEGAL study

Three Studies

“Galicia provides the first population-based real-world evidence of the impact of nirsevimab to prevent RSV disease in infants, showing a reduction by almost 90% in the number of hospitalizations due to this virus when compared with several previous RSV seasons. This achievement is the result of the exemplary pragmatic collaboration among scientists, industry, healthcare providers and policy makers aligned with a carefully planned roll-out of the immunization campaign, and the outstanding response of the Galician parents to this prophylaxis campaign.”

The authorisation was supported by three studies: the Phase 3, 12-month open label study (M15-741 study) which evaluated the long-term safety, tolerability, and efficacy of continuous subcutaneous infusion of foslevodopa/foscarbidopa , the Phase 3, 12-week study (M15736 study) which compared the efficacy and safety of foslevodopa/foscarbidopa to oral levodopa/carbidopa2, and a Phase 1 pharmacokinetic comparability study.

The most frequent adverse reactions (greater than or equal to 10 percent) were infusion site events (infusion site erythema, infusion site cellulitis, infusion site nodule, infusion site pain, infusion site oedema, infusion site reaction, and infusion site infection), hallucination, fall, and anxiety.

The majority of infusion site events were non-serious, mild or moderate in severity and resolved spontaneously or with treatment.1 References available on request BEYFORTUS REAL-WORLD EVIDENCE PUBLISHED IN THE LANCET SHOWS 82% REDUCTION IN INFANT RSV HOSPITALIZATIONS Beyfortus reduced respiratory syncytial virus (RSV) hospitalizations by 82% (95% CI: 65.6 to 90.2) in infants under 6 months of age, compared to infants who received no RSV intervention, according to the interim results of an ongoing study published in The Lancet. These results, from the first RSV season after Beyfortus’ introduction, are part of the three-year NIRSE-GAL study conducted in Galicia, Spain under a collaborative framework with the Galician Directorate of Public Health of the Xunta de Galicia (Galician government) and Sanofi.1 The results echo real-world evidence (RWE) reported from several broad infant immunization programs across the US, Spain and France during the 2023-2024 RSV season, which add to the consistent and high efficacy seen in pivotal clinical studies with Beyfortus. Real-world evidence demonstrates if a treatment or immunization is effective in dayto-day practice, as opposed to “efficacy” determined in carefully controlled clinical trials. A favorable safety profile was observed following Beyfortus use, consistent with clinical study results.1-10

PHARMACYNEWSIRELAND.COM

Thomas Triomphe Executive Vice President, Vaccines, Sanofi “The scale and speed of impact seen after Beyfortus’ introduction demonstrates the strength of all-infant immunization strategies against RSV in babies. In Galicia, we saw an effectiveness of 82% in reducing RSV hospitalizations following the launch of Beyfortus, with more than 90% of eligible infants immunized. A growing body of evidence from these programs support policymakers, healthcare providers and parents who share our collective ambition to safeguard babies from RSV disease.”

NIRSE-GAL is a large, populationbased, three-year follow-up study to evaluate the effectiveness of Beyfortus following its inclusion in the Galician immunization schedule. The study aims to measure the impact of Beyfortus on hospitalizations due to RSV, all-cause lower respiratory tract disease, severe lower respiratory tract disease caused by RSV, all-cause lower respiratory tract disease hospitalizations, and all-cause hospitalizations among infants born during the RSV season, infants under 6 months of age at the start of the season, and children aged 6-24 months who are vulnerable to severe RSV disease at the start of the season.

The 2023-2024 immunization campaign ran from September 25, 2023 to March 31, 2024.1 RWE from countries with Beyfortus all-infant immunization programs in 2023-24

in the US Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report (MMWR) shows a single dose of Beyfortus was 90% effective in preventing hospitalizations due to RSV in babies who were immunized below 8 months of age.2 • A recent draft recommendation from Haute Autorité de Santé in France reported, across six hospitals, an effectiveness of 83% against RSV-associated hospitalization in infants who received Beyfortus compared to those with no intervention.3 • In Catalonia, Spain, a study pre-printed in The Lancet showed reductions of 87.6% and 90.1% in hospital and ICU admissions for RSV, respectively, among babies born before the start of the RSV season, who were eligible to receive Beyfortus, compared to those with no intervention.4 • A pooled analysis of data from three Spanish regions, including Valencia, Murcia, and Valladolid, showed an 84.4% effectiveness in preventing hospitalizations due to RSV in infants under 9 months of age versus infants who received no intervention.

The results were published in Eurosurveillance.5 • A study from Navarra, Spain published in Vaccines found an effectiveness of 88.7% in preventing hospitalizations among infants immunized at birth with Beyfortus, compared to no intervention.6 The expansion of the Beyfortus manufacturing network is progressing well and according to plan. This expansion will allow Sanofi and AstraZeneca to more than triple manufacturing capacity. Based on this, and assuming regulatory validations are delivered in due time by regulatory agencies, Sanofi and AstraZeneca are confident to meet global commitments and build inventory that can be used in future RSV seasons. In addition, the companies are producing Beyfortus well in advance of the RSV season, with the vast majority of doses planned to be available

by October.

References available on request

In addition to this new effectiveness study, evidence of the high impact following Beyfortus’ introduction has been consistently shown in several other real-world studies.

TAR-210 RESULTS SHOW 90 PERCENT RECURRENCE-FREE SURVIVAL AND 90 PERCENT COMPLETE RESPONSE IN PATIENTS WITH HIGH-RISK AND INTERMEDIATE-RISK NONMUSCLE-INVASIVE BLADDER CANCER, RESPECTIVELY

• An interim analysis of 2023-24 surveillance data published

Janssen-Cilag International NV, a Johnson & Johnson company,

97 has announced updated results from an open-label, multicentre, multi-cohort Phase 1 study of the safety and efficacy of TAR210, an intravesical targeted releasing system designed to provide sustained, local release of erdafitinib into the bladder, in patients with non-muscle-invasive bladder cancer (NMIBC) with select FGFR alterations.1 These data were featured today in an Oral Presentation Session (Abstract #PD48-02)1 at the 2024 American Urological Association (AUA) Annual Meeting taking place 3-6 May, 2024, in San Antonio, Texas.

Results featured updated data from Cohort 1 (C1); patients with recurrent, Bacillus Calmette-Guérin (BCG)-unresponsive high-risk (HR) NMIBC (high-grade Ta/T1; papillary only) who refused or were ineligible for radical cystectomy and Cohort 3 (C3); patients with recurrent, intermediate-risk (IR) NMIBC (Ta/ T1) low-grade papillary disease left in situ as tumour marker lesions.1 First results were featured at the European Society for Medical Oncology 2023 Congress, with interim results presented at the European Association of Urology (EAU) 2024 Annual Congress.2,3 “Advancement in the treatment landscape of high or intermediaterisk non-muscle-invasive bladder cancer has remained stagnant for more than 50 years,” said Antoni Vilaseca*, M.D., Ph.D., of the Hospital Clínic de Barcelona, presenting author of the Phase 1 TAR-210 study. “Results presented today further underscore that TAR210 for the localised treatment of bladder cancer may offer a promising alternative for patients with limited treatment options.”

At the data cutoff of 22 March, 2024, 64 patients had been treated with TAR-210 across the two cohorts.1 Of the 21 patients in C1 with HR-NMIBC, the 12-month recurrence free (RF) survival rate was 90 percent (95 percent confidence interval (CI), 66-97).1 In C3, 31 patients were efficacy evaluable with 28/31 achieving a complete response (CR) rate of 90 percent (95 percent CI, 74-98).1 The most common treatmentrelated emergent adverse events (TEAEs) were Grade 1/2 lower urinary tract events.1 There were no dose-limiting toxicities and no deaths.1 Two patients (3 percent) discontinued the study due to TEAEs of low-grade urinary symptoms and two patients had serious TEAEs with pyelonephritis and sepsis or UTI (urinary tract infection) and sepsis, respectively.1 “FGFR genetic alterations are most common in NMIBC,” said Sabine Brookman-May, M.D., Vice President, Late Development

Oncology, Johnson & Johnson Innovative Medicine. “These results further support the potential of TAR-210 with quarterly administration as a bladdersparing and BCG-free treatment option, underscoring our deep commitment to pioneering novel therapies for patients who face limited treatment avenues.”

“At Johnson & Johnson, we are committed to transforming bladder cancer treatment with novel drug delivery technology and precision-based therapies,” said Henar Hevia, Senior Director, EMEA Therapeutic Area Lead, Oncology at Johnson and Johnson Innovative Medicine. “As the data continue to mature, it is encouraging to see sustained positive responses to treatment.

We look forward to investigating the full potential of TAR-210 in patients with FGFR-altered non-muscle invasive bladder cancer through an ongoing and comprehensive clinical development programme.”

Europe has one of the highest rates of bladder cancer in the world4 with nearly 225,000 patients diagnosed in 2022,5 a 10 percent increase from 2020.6 NMIBC constitutes approximately 75 percent of all newly diagnosed bladder cancers.7 Currently, adjuvant intravesical immunotherapy with BCG or intravesical chemotherapy is the standard of care for patients with intermediate- and highrisk NMIBC.8 Between 30 to 40 percent of patients do not respond to BCG, facing disease recurrence or progression.9 In such scenarios of HR-NMIBC, radical cystectomy (removal of the bladder) emerges as the primary treatment option.9 This major abdominal procedure requires a urinary diversion to be created to collect and store urine.10 References available on request URGENT CALL TO ‘MAKE LUPUS VISIBLE’ AS NEW RESEARCH SHOWS THE IMPACT THE AUTOIMMUNE DISEASE HAS ON PATIENTS’ LIVES

affects women within the 15–45-year-old age cohort.4 Arthritis Ireland conducted a new survey to understand the impact of lupus and to know more about the day-to-day problems that affect those living with the disease. 90% of those surveyed indicated that lupus negatively impacts physical activity and their ability to exercise.

69% said lupus negatively impacts their family life and over 70% of those surveyed reported that the condition negatively impacts on their career, with many having to take prolonged time off work.

Respondents also indicated a negative impact on their mental health due to their disease with anxiety (57%), loneliness (45%) and depression (36%) featuring strongly. (refer to reference 1) As part of their joint initiative, Arthritis Ireland and AstraZeneca Ireland are calling on people living with lupus or who have family with the condition to share their stories online using the hashtag #makelupusvisible.

Commenting on the results of this survey, Arthritis Ireland chief executive Gráinne O’Leary said, “The results of this Arthritis Ireland survey clearly indicate the huge impact lupus has on the day-today lives of those living with the disease. As lupus predominately affects women between the ages of 15 and 45, it can have a significant impact on fertility and on family life in general. There is a financial burden as well with many patients having to take time off work. At Arthritis Ireland, we provide support and resources for those living with lupus and through this campaign are aiming to increase awareness of the condition amongst the general public.”

Pictured at the Butterfly House, Malahide Castle is Ruth Levins from Drogheda who lives with lupus and Arthritis Ireland chief executive Gráinne O’Leary

In Ireland, Lupus is recognised as a relatively uncommon condition, but its exact prevalence is difficult to determine due to the complexity of its diagnosis, variability of its symptoms, and lack of official data on prevalence. There is also a large unmet need in relation to effective and targeted treatments for lupus.

Speaking to the difficulties of diagnosing lupus and the lack of dedicated treatments, Professor Gráinne Murphy, Consultant Rheumatologist from Cork University Hospital said, “Lupus remains a challenging diagnosis to treat. While there have been significant therapeutic advances in many other immunemediated conditions, there have been many disappointments in clinical trials for SLE. In more recent times, reassuringly, there have been some positive developments in clinical research which have led to the development of a limited number of new therapies.

Unfortunately, these agents are not yet widely available and equity of access remains an issue. There remains a significant need for more effective treatment options.”

References available on request 78% OF CHILDREN IN LEINSTER ARE REPORTED NOT TO CONSUME THE RECOMMENDED DAILY AMOUNT OF FRUIT AND VEGETABLES EVERY DAY ACCORDING TO RESEARCH FROM VIVIO® JUNIOR A study by innovative children’s range Vivio® Junior has revealed the concerns that parents in Leinster have around their children’s health and immunity.

The research,* shows that 8 in 10 (80%) parents surveyed from Leinster claim they aim to keep their children healthy by providing them with a healthy diet / ensuring that they are eating a variety of foods, with just under half (49%)

Arthritis Ireland and AstraZeneca Ireland came together on World Lupus Day to call for people living with lupus to share their stories to increase visibility of the autoimmune condition and its impact on patients.

Lupus, also known as Systematic Lupus Erythematosus (SLE), is a complex autoimmune disease that is experienced differently by each person and causes a variety of symptoms, including skin rash, joint pain, swelling and fevers.2 It is an often under recognised condition that can take many years to be diagnosed3 and disproportionately

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98

Clinical Profiles

claiming they use vitamins and supplements. Only 1 in 5 (21%) parents claim their child(ren) are consuming five portions of fruits and vegetables every day.

As the seasons change, so too do the myriad of concerns that parents have. Just over half (54%) of parents surveyed in the region claim illness is their main concern, almost half (48%) are concerned about schoolwork and keeping grades high, while just over a third (35%) listed their children socialising with peers as their biggest concern.

The research also revealed how parents of school-going children are experiencing 'lunchbox anxiety'. Over a third (37%) of parents surveyed in Leinster find it difficult to come up with new ideas for lunchboxes, with females (43%) more likely to claim they find it difficult to present new ideas on a daily basis. Inspiration for lunchboxes is most likely to come from friends (58%), social media (34%) or online recipes (26%).

Growing children need to absorb vital nutrients from their food but to do so they need to be eating enough of the right foods. The Vivio® Junior expert Clinical Nutritionist is supporting parents in providing a holistic approach to ensure that their children are prepared for the season ahead. Éva Hill Hamilton, Clinical Nutritionist comments, “We know parents can struggle to fulfil their children’s needs of five portions of fruits and vegetables every day – just 1 in 5 parents surveyed in Leinster are managing this every day. Equally, preparing school lunches for children can pose a problem for many parents in Leinster seeking to meet those needs. Selecting colourful fresh fruit and vegetables balanced with protein and healthy fats will provide children with a spectrum of nutrients that bolsters the immune system.

MATER PRIVATE NETWORK SELECTED AS ONE OF THREE CENTRES WORLDWIDE FOR GLOBAL AFIB STUDY Mater Private Network has been selected as one of only three centres worldwide and the only centre in Ireland to participate in the prestigious NAVIGATEPF clinical study, led by Boston Scientific. This recognition highlights Mater Private Network's status as one of the most acknowledged atrial fibrillation (AFib) centres in Europe.

The prospective, single-arm, openlabel, multi-centre NAVIGATE-PF study will begin at the Dublin site from today, Friday 10th May, marking a significant step in Mater Private Network's involvement in pioneering medical research.

AFib is the most common irregular heart rhythm, which significantly reduces the quality of life and life expectancy of patients. An estimated 8 million patients live with this condition in Europe.

The NAVIGATE-PF study will examine the FARAVIEW™ Software Module* when it is used to visualize and track the FARAWAVE™ Nav Pulsed Field Ablation (PFA) Catheter* for the treatment of patients with paroxysmal and persistent atrial fibrillation (AF).

The FARAVIEW technology and the FARAWAVE Nav catheter expand the capabilities of the FARAPULSE™ PFA System through integration with the Boston Scientific cardiac mapping system. The FARAWAVE Nav PFA Catheter adds magnetic navigation capabilities to the current

Mater Private Network’s CVRI research team involved in the study: Heta Jigar Panchal, Prof. Gábor Széplaki and Fionnuala Duffy

To support the growth and well-being of children who are not consuming sufficient fruits and vegetables, I recommend incorporating a multivitamin tonic for extra nutrients in their diet and introducing a probiotic supplement with live bacteria.

These measures can improve gut health, assist in nutrient absorption, and boost immunity.

As the seasons transition and children develop colds or coughs, natural remedies that can alleviate the symptoms without suppressing them are also beneficial.

Remember, coughs act as the body's innate defence mechanism to expel and safeguard against harmful substances.”

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FARAWAVE PFA catheter, enabling detailed mapping and PFA therapy within the same device.

focused on advancing medical science and improving the health of those it serves.

This mapping data is visualised using the new FARAVIEW Software Module, offering a tailored mapping solution for procedures with the FARAPULSE PFA System.

This will be the second generation of the novel FARAWAVE catheter as a part of the FARAPULSE PFA System, which has had extensive real-world use demonstrating safety of the system with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or oesophageal injury.

In a pulsed field cardiac ablation procedure, a catheter is guided into the heart to administer targeted non-thermal electrical fields that selectively treat heart tissue cells, while avoiding damage to nearby structures.

Mater Private Network has been one of the first centres which has adopted the groundbreaking technology and delivered >750 procedures since 2022.

Prof. Gábor Széplaki, Head of Cardiac Electrophysiology at Mater Private Network, expressed his enthusiasm for the project: "We are honoured to participate in this groundbreaking study, which will be another milestone in our journey to transform the way arrhythmias are treated globally. This initiative represents a significant stride towards integrating advanced cardiac mapping with ablation technology, aiming to elevate the standard of care for our patients with atrial fibrillation.

As a centre of excellence in cardiac electrophysiology, we are committed to contributing to research that may significantly improve patient outcomes. As early adaptors of the most advanced technologies we are hoping to deliver safe and efficient therapies to the wider patient populations, including elderly patients living with atrial fibrillation."

Mater Private Network continues to demonstrate its commitment to medical innovation and dedication to providing the latest and most effective treatments to its patients.

The Electrophysiology team is offering comprehensive, multidisciplinary patient management at the Atrial Fibrillation Institute in Dublin. The network remains

LONQUEX® (LIPEGFILGRASTIM) RECOMMENDED AS A BESTVALUE BIOLOGICAL ON THE HIGH TECH ARRANGEMENT

Teva Pharmaceuticals is pleased to announce that the Medicines Management Programme (MMP) now recommends Lonquex® (lipegfilgrastim) as a Best-Value Biological (BVB) Medicine for the long-acting granulocyte-colony stimulating factors on the High Tech Arrangement. Prescribing Lonquex® will lead to significant savings for the health service.

Lonquex is indicated in adults for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndrome).

Contact your local Teva representative, for any queries in relation to Lonquex® (Lipegfilgrastim).

Further information is available upon request or from the SmPC available at HPRA.ie. Product Information is also available on the HPRA website.

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: May 2024 Job code: LQX-IE-00005

99 FIRE1™ System for remote heart failure monitoring. The innovative system has the potential to positively impact thousands of people living with heart failure in Ireland every year and alleviate the burden on hospital emergency rooms. The successful implantation took place at University Hospital Galway in the First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF). The study will assess FIRE1’s novel solution to improve outcomes for those living with heart failure.

BREAKTHROUGH AT TYNDALL REVOLUTIONISES SURGICAL NAVIGATION FOR CANCER A groundbreaking development by researchers at Tyndall National Institute and Microelectronics Circuits Centre Ireland (MCCI), based at University College Cork (UCC), is set to transform surgical navigation. In a significant breakthrough, researchers have developed the first sensor-on-a-chip for magnetic tracking in surgery and other image-guided interventions.

This development accelerates a move away from reliance on harmful radiation imaging (x-rays) towards a safer, more precise approach to navigating medical instruments within the body.

Traditional image-guided interventions often use x-rays for navigation of instruments.

However, a pioneering technology known as ‘magnetic tracking’ is revolutionising clinical practice by minimising the dependency on x-rays, while accelerating the use of surgical robotics and image-guidance.

Magnetic tracking uses lowfrequency magnetic fields, similar to everyday devices like electric motors and radios, to precisely detect the position of tiny sensors inside the patient. However, existing sensors are complex to manufacture, they are expensive, and are extremely delicate.

Preliminary results published in the IEEE Transactions on Biomedical Circuits journal report tracking accuracy of less than a millimetre, making the new sensor the most accurate on-chip sensor to date for navigating instruments inside the body.

Researchers were able to demonstrate the use of the chip for tracking instruments inside the lungs, an important application for effective targeting and treatment of diseases like lung cancer, which is the leading cause of global cancer incidence and mortality (source: ncbi.nlm.gov).

The sensor is manufactured using standard silicon chip technology resulting in a simplified manufacturing process. Silicon chips are cost-effective at scale allowing the technology to be manufactured at a fraction of the cost of existing medical sensor technology. Silicon chips are also easily integrated with the latest flexible circuits, making assembly quick and reliable.

Pádraig Cantillon-Murphy, Professor of Biomedical Engineering at Tyndall and UCC, who led the research team, said: “This represents the culmination of

Professor Pádraig Cantillon-Murphy and Researcher Manish Srivastava 10 years development of magnetic tracking technology at Tyndall and UCC. I'm immensely proud of the team's achievements over that time and we look forward to translating this technology to clinical applications where it can make a significant difference in patient outcomes.”

Marcus Kennedy, Professor of Medicine at Cork University Hospital and President of the Irish Thoracic Society who has been collaborating with Tyndall and UCC said: “Magnetic navigation has huge potential in helping with the diagnosis of diseases like lung cancer. Accurate and low-cost access to peripheral lung cancers via bronchoscopy provides a pathway towards not only safe and low-cost biopsy, but also endobronchial treatment of lung cancer without the need for invasive surgery. However, the high costs of robotic-assisted interventions and the cost per tracked instrument are prohibitive in most countries.

This on-chip sensor could be a real game-changer for navigation in bronchoscopy and many other image-guided interventions.”

Irish medtech company FIRE1, whose CEO, Conor Hanley was recently announced as a 2024 EY Entrepreneur of the Year finalist, seeks to transform heart failure management by enabling patients to monitor and control their fluid volume themselves with a device at home, similar to how continuous glucose monitoring transformed diabetes care. Fluid overload is a classic clinical feature of heart failure, which affects approximately 90,000 Irish people and is a leading cause of hospitalisations, including high admission and readmissions rates in Ireland.

FIRE1 CEO and President, Conor Hanley said: “I am especially pleased to announce our first patient in Ireland. This represents a true clinical research success for Ireland, being one of the first systems of its nature to be developed, manufactured and now to be in a clinical trial in Ireland. It showcases Ireland's capability for groundbreaking medical innovation with the potential to change healthcare delivery globally. The FIRE1 team is steadfast in our mission to help millions of people around the world living with heart failure to get their normal lives back, but it is very special to be able to give access to people here at home. It is gratifying to see the physician interest in our novel technology. I would like to extend

my thanks on behalf of the whole FIRE1 team to the fantastic staff at UHG, and most importantly to the patients who continue to put their trust in us and participate in this important research.”

The FIRE1 sensor is implanted into the body's largest vein, located in the abdomen, known as the inferior vena cava (IVC) and works by continuously measuring the size of the IVC, giving a marker of the amount of fluid in the body.

High levels can increase the risk of breathing difficulties and a build-up of fluid in the lungs which lead to an emergency hospital admission. The patient wears a belt reader around the abdomen for around a minute a day to take a reading from the sensor and the data is sent to the patient’s clinical team at the hospital. The system is designed to alert whenever the patient's condition deteriorates.

Professor of Interventional Cardiology and Translational Medicine at University Hospital Galway (UHG), Prof Faisal Sharif performed the implant. “We are delighted to bring this new, transformative technology to Ireland for the first time,” said Prof Sharif. “The procedure was very straightforward, minimally invasive and the patient was confident using the FIRE1 system and taking the readings. The data we will get from this patient will give a new window into heart failure management and has the potential to dramatically improve our understanding of this patient’s condition, and to enable proactive changes in medications that will keep them healthy and at home. We hope to implant further patients at UHG while recruitment is still active.”

Conor Hanley of FIRE1. EY EOY 2024 Finalist. Photograph by Naoise Culhane

The breakthrough research was made possible through funding from the European Research Council, Science Foundation Ireland, Enterprise Ireland, and through the Microelectronics Circuit Centre Ireland (MCCI) at Tyndall.

FIRST IRISH PATIENT IMPLANTED WITH INNOVATIVE HEART FAILURE MANAGEMENT SYSTEM FROM IRISH COMPANY FIRE1 Dublin-based FIRE1 ha announced that the first Irish patient has been successfully implanted with its

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LET HER SHINE IN THE SUN WE KEEP HER PROTECTED

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