IPN September 2024 by IPN Communications LTD

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Fruity flavoured liquid food supplement containing a unique blend of vitamins and minerals with added L-lysine. Offering nutritional and immunity support to the little ones!

Page 4: Welcome for Pharmacist

Prescribing news

Page 6: Boots Ireland gain Reputable Status

Page 8: Over 700,000 Illegal Medicines Detained

Page 12: Axium Buying Group expand Operations team

Page 14: Expert taskforce publishes Pharmacy Report

Page 22: Women encouraged to love their hearts

Page 36: School of Pharmacy publish Antipsychotic-Induced Weight Gain research

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Anna Cotter

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Naomi Thornton

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Irish Pharmacy News is circulated to all 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.

Foreword

In one of our lead news stories this month, we report on the publication of the Expert Taskforce established by Health Minister Stephen Donnelly to support the expanded role of community pharmacy.

The Expert Group has recommended that pharmacists should be able to prescribe for a range of common conditions. They have recommended an initial list of eight conditions which can be extended over time as the service evolves. The Group has also recommended the development, over the coming years, of more widespread models of pharmacist prescribing across the health service.

The news has been welcomed across the profession. Joanne Kissane, Registrar and Chief Officer of the Pharmaceutical Society of Ireland, and member of the Expert Taskforce said the recommendations represent ‘another important milestone, providing clear policy direction and a roadmap for delivery of an expanded scope of practice for pharmacists, for the benefit of patients and the health system.’

Meanwhile Tom Murray, President of the Irish Pharmacy Union stated that while the Taskforce and Minister Donnelly are to be commended for getting the process to this stage, ‘a lot of work still needs to be done before implementation can happen. This will require all stakeholders engaging in a collaborative way and agreeing the various protocols and addressing all funding issues.’

On page 8, we reveal that the HPRA has reported continued detentions of substances for likely cosmetic and body image purposes including anabolic steroids and Semaglutide products whilst on page 36, a first-of-its-kind study from St Patrick’s Mental Health Services and University College Cork explores the preferences and needs of those with lived experiences of weight gain from anti-psychotics.

A qualitative study from researchers within the Pharmacy Department of St Patrick’s Mental Health Services and the School of Pharmacy in University College Cork has revealed the urgent need for tailored guidelines in managing antipsychotic-induced weight gain, as findings highlight the gaps between current guidelines and practices and the needs of those taking antipsychotics.

Professor Laura Sahm, co-author of the study and Head of Clinical Pharmacy Practice at UCC, said: “This study represents a crucial step in recognising the importance of a patient-centred and patient-informed approach to combat antipsychoticinduced weight gain. By working collaboratively, patients and prescribers can adopt a strategy that aligns best with their shared and agreed goals of therapy.”

I hope you enjoy the issue.

Regulars

FEATURE:

Welcome for Pharmacy Prescribing

RCSI University of Medicine and Health Sciences has welcomed the announcement by the Minister for Health that pharmacists will be able to prescribe, commencing with prescribing for a range of common conditions.

The Government’s decision follows a recommendation made by the Expert Taskforce to Support the Expansion of the Role of Pharmacy. The group recommended that pharmacists be enabled to prescribe independently, within their scope of practice and competence. This is to be a stepwise implementation, with the introduction of a common conditions service. An initial list of eight conditions for which pharmacists will be able to

Professor Judith Strawbridge,

School of Pharmacy and Biomolecular Sciences, RCSI

¤180m Hole in Cancer Funding

prescribe was outlined: allergic rhinitis, cold sores, conjunctivitis, impetigo, oral thrush, shingles, uncomplicated UTI and vulvovaginal thrush.

Welcoming the announcement, Professor Tracy Robson, Deputy Vice-Chancellor for Academic Affairs, RCSI said, “This decision marks a really important and positive development for patients and the wider health system. Worldwide there is broad agreement that the most promising model for a sustainable healthcare system is one that increases productivity by extending the

scope of practice of healthcare professionals like pharmacists.”

“We look forward to supporting the education and training of pharmacists for pharmacist prescribing, as outlined in the recommendations”, added Professor Robson.

Professor Judith Strawbridge, School of Pharmacy and Biomolecular Sciences, RCSI, is a member of the Expert Taskforce to Support the Expansion of the Role of Pharmacy. She added, “It was a privilege to work with everyone on the Taskforce, colleagues from across the healthcare professions and our patient partners, to bring these recommendations to the Minister for Health.

“Pharmacists are exceptionally wellqualified healthcare professionals who already deliver a range of important healthcare services to their patients. The expansion of their role, to include prescribing, will allow them to enhance their contribution to healthcare for the benefit of patients.”

The PSI launches new website at www.psi.ie

The Pharmacy Regulator has launched a new website that can be visited at www.psi.ie As part of its extended Corporate Strategy 2021-2024, the new website supports the PSI’s commitment to engage in a broad and accessible manner with patients, the public and registrants and to communicate clearly and consistently with stakeholders that include the Department of Health, HSE, other public bodies, regulators and the media.

The new website is mobile responsive and user-friendly with improved accessibility and design. It hosts the registers for pharmacies, pharmacists, pharmaceutical assistants, and the Internet Supply List which are searchable from the homepage. The PSI’s website redevelopment project also supports its commitment as a public body to becoming a digital-first regulator. Underway at the PSI, is a digital transformation programme ‘Better Ways of Working’ that is bringing numerous benefits to the organisation and its registrants and is delivering effective and efficient digital services to members of the public, supported by welldesigned, reliable and robust technology solutions.

“Effective and clear communication and engagement with our stakeholders including

the public is central to our remit as the pharmacy regulator,” said Joanne Kissane, Registrar and Chief Officer, PSI – The Pharmacy Regulator. “The new website is created on a modern scalable digital platform and the innovative approach we’ve taken will help us to build even greater awareness of our role, so that the public can be informed of the standards they can expect from pharmacists and pharmacies. As our primary communication channel, the new website will serve us well into the future as we look to support enhanced and expanded pharmacy services in Ireland.”

The new website delivers an intuitive layout, enhanced search functionality and utilises multimedia in a seamless and engaging way. It also features imagery from pharmacies across Ireland and from within the PSI offices, which were specially commissioned to

give an accurate and authentic representation of modern pharmacy services and pharmacy regulation in Ireland.

The Irish Cancer Society has launched it’s Budget 2025 Submission, urging the Government to stop underfunding the National Cancer Strategy. This call for investment in the National Cancer Strategy is supported by the two main representative bodies for cancer doctors in Ireland, the Irish Society of Medical Oncologists (ISMO) and the Irish Society of Radiation Oncologists (ISRO).

According to the HSE, the National Cancer Control Programme’s annual budget for implementation of the National Cancer Strategy should have increased incrementally over the past 8 years to be ¤110m higher in 2024 than in 2016. The actual incremental increase has only been ¤65m. As a result, the cumulative loss of investment in cancer services from 2017 to 2024 is almost ¤180m.

Due to this underfunding:

• screening has not been expanded as planned;

• target waiting times for cancer are not being met;

• cancer surgeries are frequently delayed;

• investment in infrastructure is lacking;

• radiotherapy services are operating below capacity;

• clinical trials are falling far short of target; and

• access to new medicines is much slower in Ireland than in other European countries.

CEO, Averil Power said, “In the latest year for which comparable data is available, Ireland’s cancer mortality rate was the third highest in Western Europe. Ireland is a leader in many areas. We should not be a laggard in cancer care.

“Budget 2025 must prioritise the National Cancer Strategy, with ringfenced new recurrent development funding for the National Cancer Control Programme of at least ¤20 million.”

The Irish Cancer Society is also urging the Government to address the cost of cancer for cancer patients in Budget 2025, which requires action from several government departments. Recommendations include the abolition of hospital parking fees and a statutory ‘right to be forgotten’ for cancer survivors.

Supporting Skin Cancer Patients

A new guideline launched by the HSE National Cancer Control Programme, aims to support patients who have been diagnosed with melanoma skin cancer. Around 1,100 people are diagnosed with melanoma each year in Ireland, which has become more common in recent years. The guideline will help provide information for treatment planning for people with melanoma. It will also help catch any recurrence or relapse early, leading to earlier treatments and interventions. It was developed in consultation with oncology patients, doctors, nurses and researchers. It aims to improve the quality of clinical care for patients and improve patient experience.

Benefits to patients include:

• Provides information for treatment planning

• Catch a recurrence/ relapse early

• Reassurance that you are being monitored based on the best current evidence

Dr Sinéad Field, Consultant Dermatologist and Chair of the clinical guideline development group, said,

“The new National Clinical Guideline for Radiological Staging and Surveillance of Patients with Cutaneous Melanoma will support people who are undergoing or have had treatment. Staging scans help to determine if a patient’s cancer has spread or is likely to spread to other parts of the body, or recur. This knowledge is useful as it provides an opportunity to optimise the patient’s treatment plan. Surveillance of patients after they have finished their treatment is to check for a recurrence or relapse of their cancer. This is useful as it provides an early opportunity for treatment.”

Dr Eve O’Toole, Head of Evidence and Quality Hub in the NCCP, added, “The purpose of the guideline is to provide evidence-based recommendations on the staging and surveillance of patients with cutaneous melanoma through the integration of the best research evidence with clinical expertise, patient values and experiences.”

New Medicines Funding Urgency

Ahead of Budget 2025, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international research-based biopharmaceutical industry, reiterates the importance of funding new medicines which are an integral and vital part of our healthcare system.

Advances in medical development are steadily growing. To ensure that patients in Ireland can access these therapeutic advances, it is vital that a direct allocation for new medicines is provided for again in 2025 as was done in 2021, 2022, 2023 and eventually in 2024.

For 2025, IPHA members expect to make applications for reimbursement for 36 medicines which, according to most recent estimates, would benefit as many as 3,700 patients in Ireland. These medicines would improve the standard of care for patients suffering from a number of diseases such as cancer – breast cancer, leukaemia, prostate cancer, multiple myeloma and others – Alzheimer’s, stroke, women’s health conditions, migraine, dermatitis, asthma, ulcerative colitis, type 2 diabetes and liver disease. Along with benefitting thousands of patients, these life-enhancing medicines will also positively impact the lives of their families and carers.

It is estimated that an allocation in the order of ¤25 million in new development funding for new medicines in 2025 is required to allow patients in Ireland access to these new life-enhancing treatments.

Budget 2024 initially allocated zero funding for new medicines. Thankfully, this decision was reversed by the Government last December with ¤20 million allocated for new medicines and a further ¤10 million to be made available through savings. As a consequence, by 1st July 2024, 20 new medicines – both IPHA (13) and non-IPHA (7) – have already been reimbursed by the HSE. Current data indicates that at least 700 patients and their families and carers are benefitting from 15 of those new medicines. Further positive reimbursement decisions this year should benefit several thousand patients more.

IPHA Chief Executive Oliver O’Connor said “We believe that there needs to be a clear policy to plan for and fund the

continuous flow of life-enhancing new medicines in 2025 and over multiple years. Efficiencies are both possible and desirable to make the medicines spend sustainable but alone they cannot provide sufficient funding for the uptake of new medicines. Annual new developments Exchequer funding remains a necessity.”

“IPHA member companies are actively delivering significant savings to the State on an annual basis via the Framework Agreement we agreed in 2021 and which expires in September 2025, within the Budget year now being considered. This Agreement has delivered more than ¤400m in savings in its first two years of implementation, well above the anticipated overall savings of between ¤600-¤700 million for the full four-year period. We remain ready and willing to partner with the Government to achieve certainty for clinicians and patients and to work with the HSE to bring newly-authorised medicines to the Irish healthcare system as quickly as possible.”

Setting the McCabes Way Forward

McCabes Pharmacy recently kicked off their ‘The McCabes Way’ Roadshow across Ireland.

The McCabes Way training roadshow began in Citywest, codifing the core values and practices that their Pharmacy teams embody every day, as they deliver exceptional patient care and customer service.

Said a pharmacy spokesperson, “This summer, we’re thrilled to bring this training experience on the road, connecting with our LloydsPharmacy colleagues across the country. We look forward to uniting our teams, as we rebrand to McCabes Pharmacy, and sharing best practices as we transition into Ireland’s largest pharmacy chain.

“Together, as both Lloyd’s and McCabes Pharmacy, we’re setting the standard for unrivalled service and patient care across the country.”

Sharon McCabe, CEO, McCabes, Dervilla McGarry, Head of Marketing, PHX Ireland and Elaine O’Neill, Manager, McCabes

Reputable Status for Boots

Boots Ireland is proud to announce that they have been recognised as one of the most reputable organisations in Ireland, securing third spot this year in the Ireland RepTrak® 2024 study.

Not only have they secured the third position overall, gaining five places on last year, but they are also thrilled to maintain their status as the most reputable pharmacy chain in Ireland for the 15th consecutive year.

Conducted by The Reputations Agency this exhaustive examination of reputation is the largest and longest running in Ireland, drawing insights from thousands of members of the public.

A spokesperson said, “At the heart of our business is a deep commitment to care for our customers, patients, the communities we serve, and the planet. A commitment brought to life by our amazing team members across the country every day.”

Boots Ireland Managing Director Stephen Watkins is pictured right with Niamh Boyle, CEO of The Reputations Agency at the launch of this year’s study

Women in Leadership

The Pharmaceutical Managers’ Institute final Women in Leadership event of 2024 takes place on 16th October at Kingswood House Hotel, Dublin. They will host Averil Power, CEO with the Irish Cancer Society as the guest speaker. Averil is currently leads one of the best known patient advocacy groups in the country, having previously held the role of CEO in the Asthma Society. Prior patient advocacy, Averil was heavily involved in politics, having been employed as a political adviser by Minister Mary Hanafin in the Departments of Tourism, Social and Family Affairs and Education.

Severe Asthma Project

The Irish Asthma Society Severe Asthma Project aims to establish barriers and potential enablers to better care, treatment (including accessibility), and welfare support for people with asthma. They are currently looking for people with diagnosed and undiagnosed severe asthma to participate in an online survey and focus group.

The purpose of the survey is to document the challenges facing those with severe asthma and the solutions which should be addressed at the policy and clinical level.

The focus group session will take place in early September and aims to explore key challenges experienced by people with severe asthma (or suspected severe asthma). The findings, which will be anonymised, will inform an Asthma Society report calling for government action to enhance severe asthma diagnosis, care and treatment in Ireland.

They invite adults and parents/ carers of children with severe or difficult-to-control asthma (as detailed below) to join. The virtual focus group discussion will take place on Thursday 5 or Friday 6 September, from 1 – 2:30 pm via Microsoft Teams.

Severe asthma is defined as asthma that requires treatment with high-dose inhaled corticosteroids plus a second controller and/or systemic corticosteroids to prevent it from becoming ‘uncontrolled’, or that remains ‘uncontrolled’ despite this therapy.

Experts consider severe asthma to be present in any of the following four cases:

Someone who is prescribed a long-term injection treatment for their asthma, often referred to as biologicals.

They have ever ended up in intensive care with their asthma OR

They have had to stay overnight in an Emergency Department or were admitted to hospital with asthma in the past 12 months OR

They are prescribed medications to prevent their asthma from becoming ‘uncontrolled’ or that remains ‘uncontrolled’ despite this therapy.

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Over 700,000 Illegal Medicines Detained

HPRA reports continued detentions of substances for likely cosmetic and body image purposes including anabolic steroids and Semaglutide products

The Health Products Regulatory Authority (HPRA) has reported a sharp increase in the volume of illegal medicines detained in the first half of 2024 compared to the same period last year. The HPRA’s enforcement section detained 706,881 dosage units of falsified and illegal medicines between January and June 2024, compared to 551,582 units for the same period last year. Announcing its detention figures, the HPRA cautioned the public of the serious health risks posed by prescription medicines being purchased online from unauthorised sources. It states that there is no guarantee as to the safety or quality of illegal prescription medicines purchased outside of the regulated pharmacy setting.

In the first six months of 2024, the most significant categories of illegal products detained included anabolic steroids (23%), analgesics (14%), sedatives (11%) and erectile dysfunction medicines (10%)

The breakdown is as follows:

 Anabolic Steroids –160,134 units detained.

 Analgesic medicines –96,481 units detained.

 Sedative medicines –80,773 units detained.

 Erectile dysfunction medicines –72,555 units detained.

As part of its enforcement measures, the HPRA continues to monitor online activity promoting prescription medicines and other substances, and routinely intervenes to disrupt this promotion. In the first six months of this year the key enforcement actions taken include:

 1,603 e-commerce listings and/ or social media pages amended or shutdown.

 One prosecution has been initiated and four voluntary formal cautions have been issued.

Gráinne Power, Director of Compliance at the HPRA

(*OzempicTM, RybelsusTM and WegovyTM)

illegal medicines online and from unregulated sources and this includes products for cosmetic and body image purposes. One such example is the amount of illegal anabolic steroids detained. We believe young men in particular, may be sourcing anabolic steroids for body enhancement while being unaware of the serious health complications posed by these products. Anabolic steroids can cause serious physical and psychological health issues. The potential physical side effects alone include heart failure, liver issues, kidney damage, and infertility.

Additionally, a notable rise is evident in detentions of Semaglutide*, a prescription medication intended for specific medical purposes such as diabetes or weight management under certain conditions. While overall the numbers detained are small in comparison to other products, we have already in the first six months of 2024 detained almost triple the volume of illegal units of Semaglutide detained last year.

Gráinne Power, Director of Compliance at the HPRA, noted the significant increase in 2024 data and the apparent willingness of many people to seek access to unregulated products which may pose significant risks to their health. She emphasized the type of units detained also give an insight into a growing tendency among some consumers to jeopardize their health for aesthetic, cosmetic and body image purposes by seeking out illegal or unapproved substances.

In conclusion, Ms Power stated that “when consumers acquire any medicinal substances outside the regulated supply chain, they forego any assurance of safety, quality, or effectiveness. Some of these substances might not be authorised by any global health authority, while others may be counterfeit or falsified despite appearing legitimate. It’s crucial not to compromise your health by taking such risks. We strongly advise anyone who has bought prescription medications from unauthorised sources to cease using them immediately and to consult their healthcare provider with any concerns about their well-being.”

(*OzempicTM, RybelsusTM and WegovyTM)

In conclusion, Ms Power stated that “when consumers acquire any medicinal substances outside the regulated supply chain, they forego any assurance of safety, quality, or effectiveness. Some of these substances might not be authorised by any global health authority, while others may be counterfeit or falsified despite appearing legitimate. It's crucial not to compromise your health by taking such risks. We strongly advise anyone who has bought prescription medications from unauthorised sources to cease using them immediately and to consult their healthcare provider with any concerns about their well-being."

“It’s alarming to see consumers willing to take risks by purchasing

Other products of note detained by the HPRA:

Units Detained

The HPRA works in close cooperation with colleagues from An Garda Síochána and Revenue’s Customs Service with whom there is significant inter-agency collaboration to combat the illegal supply of health products into and within Ireland. It also co-operates and shares intelligence with other regulatory and law enforcement agencies worldwide to prevent the illegal manufacture, importation and distribution of medicines, medical devices, and cosmetics.

The HPRA works in close co-operation with colleagues from An Garda Síochána and Revenue’s Customs Service with whom there is significant inter-agency collaboration to combat the illegal supply of health products into and within Ireland. It also co-operates and shares intelligence with

28 PACK NOW AVAILABLE

CCF: 26619 Date of preparation: (07-24)

ABBREVIATED PRESCRIBING INFORMATION

Product Name: Emazole Control 20 mg Gastro-Resistant Tablets

Composition: Each tablet contains 20 mg esomeprazole (as magnesium dihydrate).

Description: Light pink oval lm coated tablet.

Indication(s): Proton Pump Inhibitor (PPI): Short-term treatment of re ux symptoms (e.g. heartburn and acid regurgitation) in adults. Dosage: Swallow tablets whole with liquid, do not chew or crush. Disperse in half a glass of non-carbonated water if di culty in swallowing. Stir until tablets disintegrate, drink liquid with pellets immediately or within 15 min, or administer through a gastric tube. Do not chew or crush pellets. Adults: Recommended dose is 20 mg esomeprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Duration of treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. Elderly (≥ 65 years old): As per adults. Paediatric population (< 18 years): Not recommended. No relevant use in this group in the indication: “short-term treatment of re ux symptoms (e.g., heartburn and acid regurgitation)”. Severe impaired renal function: Caution. Severe liver impairment: 20 mg max daily dose. Contraindications: Hypersensitivity to esomeprazole, substituted benzimidazoles or any of the excipients. Not with nel navir. Warnings and Precautions for Use: On demand treatment: Contact a physician if symptoms change in character. In the presence of any alarm symptom (e.g. signi cant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with esomeprazole may alleviate symptoms and delay diagnosis. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium di cile. Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Absorption of vitamin B12 may be reduced due to hypo- or achlorhydria. Not recommended for long-term use as the following may also occur: Hypomagnesaemia; Risk of fracture. Consider stopping Emazole Control in cases of subacute cutaneous lupus erythematosus (SCLE) accompanied by arthralgia. Serious cutaneous adverse reactions (SCARs) such as erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening, have been reported very rarely. Patients should be advised of the signs and symptoms of the severe skin reaction EM/SJS/TEN/DRESS. Discontinue and seek medical advice immediately when observing any indicative signs or symptoms. Do not re-challenge. Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Emazole Control treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of PPI treatment. Contains glucose and sucrose.

Interactions: E ect of esomeprazole on other drugs: Co-administration with atazanavir is not recommended. If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded. Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. Serum levels of cilostazol, cisapride, tacrolimus, methotrexate may be increased. An interaction is observed between clopidogrel and esomeprazole, but the clinical relevance is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged. Gastric acid suppression by PPIs increase or decrease absorption of drugs with pH dependent absorption (decreased absorption of ketoconazole, itraconazole); esomeprazole inhibits CYP2C19 metabolising enzyme and could increase plasma concentrations of diazepam, citalopram, imipramine, clomipramine, phenytoin (monitor plasma levels of phenytoin), etc. resulting in need of a dose reduction; monitor INR when given with warfarin or similar. Caution as absorption of digoxin can increase. E ect of other drugs on esomeprazole: CYP2C19 and CYP3A4 inhibitors (clarithromycin, voriconazole) may increase the esomeprazole exposure. Dose adjustment not regularly required, except in severe hepatic impairment and long-term use. CYP2C19 and/or CYP3A4 inducers (rifampicin and St. John’s wort) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism.

Pregnancy and Lactation: Caution in pregnancy due to lack of clinical data. No studies in lactating women, therefore, not recommended during breast-feeding. Ability to Drive and Use

Machinery: Minor in uence on the ability to drive or use machines. Adverse reactions such as dizziness (uncommon) and blurred vision (rare) have been reported. If a ected, patients should not drive or use machines. Undesirable E ects: Common: Headache, abdominal pain, constipation, diarrhoea, atulence, nausea/vomiting, fundic gland polyps (benign). Uncommon: Peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, dry mouth, increased liver enzymes, dermatitis, pruritis, rash, urticaria, fracture of the hip, wrist or spine. For other side e ects refer to the SPC.

Marketing Authorisation Holder: Rowa Pharmaceuticals Ltd., Newtown, Bantry, Co. Cork. Marketing Authorisation Number: PA 0074/100/001. Further information and SPC are available from: Rowex Ltd, Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417. E-mail rowex@rowa-pharma.ie

Legal Category: Not subject to medical prescription. Date of Preparation: July 2024 CCF for API: 26593

How widespread will prescription extension by the pharmacist actually be?

Prescription extension starting in September 2024 (for prescriptions issued for six months in March 2024) is definitely the topic in community pharmacies in August (alongside preparation for another busy flu vaccination season). The question we are all asking ourselves is how many prescriptions a day will we actually extend? Will there be attempts from patients to force to extend a prescription that does not qualify for it? Will GPs limit the amount of extensions for their own valid reasons? I will attempt to answer some of these questions in the article below.

Disclaimer: By the end of August, the IIOP will have advised pharmacists on how to safely meet the requirements of prescription extension. However, at the time of writing this article, there is no such knowledge available. For anybody interested in having their pressing questions answered, the IIOP also has two webinars planned, on the 28th August and 11th September. They are usually recorded and so can be accessed anytime.

Teething pains patient –pharmacy Staff

Unfortunately, with the new service there is a potential for situations with higher emotional charge in the pharmacy. Our patients are increasingly busy and appreciate convenient and quick

Written by Anna Cotter, MPSI

delivery of their medicines. The patient might have heard on the news their regular prescription can be extended in the chemist, but upon arrival (potentially after running out of meds) they hear they still need the appointment (because their prescription was only for three months, or for one month or for certain controlled meds etc.)… Because of the prescription extension applying to specific prescriptions, there is a need to train all Staff, in the dispensary and front of shop, so everybody knows not all prescriptions can be extended. For the dispensary staff, they should also know specifically which prescriptions can be extended to avoid situations where a patient is informed their prescription will be ready in fifteen minutes and at the point of prescription check, the pharmacist identifies that the supply can’t be issued.

Teething pains patient - GP

Anecdotally, since March some surgeries started to routinely put a message ‘Do not extend’ at the end of six-month prescriptions. What interests me is if they also communicated to the patient that

Virtual Healthcare for COPD Patients

they decided to ‘opt out’ of the pharmacist prescription extension for that particular patient and the reasoning behind it? Pharmacist communicating it to the patient rather than doctor puts the pharmacy between a rock and a hard place. Perhaps patient is just out of the medicines and they didn’t make an appointment, because they heard on the telly that the pharmacist can do it as well? For surgeries that decided to take that approach, why did they do it? Do they not believe the pharmacist extension is safe for patients on multiple medicines and without a full knowledge of their medical history? Do they choose to do so for patients who need regular blood work done? Do they still want to see all their patients as normal to keep the level of care as usual (because they have adequate number of GPs in the surgery)? Do they think pharmacists lack training to evaluate if a patient is eligible for extension? Or perhaps they fear we lack tools to identify potential problems that an experienced GP would pick up in an instant?

I mean no hostility against the medical profession, rather I just aim to understand the process following the ‘Do not extend’ message and come up with most effective way to communicate it to the patient. It is not ideal for the pharmacy staff to start blaming the GP ‘Look, your doctor should have said it to you’. ‘I am sure they had a good reason for wanting to see you as usual’ is probably a better

Patients in the West of Ireland are accessing medical care from home as part of a virtual healthcare initiative being rolled out by Galway University Hospitals in collaboration with Community Healthcare West.

While the patients remain under the care of their treating doctors and medical team this new programme allows them to receive monitoring of their ongoing care from home. The initiative will also reduce the need for hospital attendance and is expected to save hundreds of bed days per year.

It is aligned to the ambitions of Ireland’s 10-year health and social care reform programme Sláintecare, which aims to avoid unnecessary hospital admissions and support patients at home.

The programme’s digital platform is delivered through mobile health apps, which help patients track key health metrics and monitor symptoms from home. A clinician dashboard displays real-time information on a patient’s condition, alerting medical professionals to changes so they can detect deterioration early and deliver timely care.

The programme has had a successful trial in the Galway- based Chronic Obstructive Pulmonary Disease (COPD) service.

way to communicate to the patient that behind the message was patient’s best interest.

Teething pains pharmacy –surgery

I suspect that the pharmacy will have to notify the surgery every time prescription is extended and the surgery staff will have to record it on patients’ file. There might potentially be a delay in busy pharmacies with regards to communication with the surgery and as a result surgery contacting the patient about the upcoming appointment etc. Despite best intentions, there might also be a situation where a supply was issued where there shouldn’t have been one. In such case, the surgery should be quickly informed about which medicines and in which quantity were given, to avoid the patient getting another supply should they choose to change pharmacies after the new prescription is issued. This is critical for the safety of patients on psychiatric meds, tranquilizers etc. Summary

To sum up, prescription extension is a great service that can benefit many patients, but perhaps not all of the qualifying patients will avail of it - as per their GPs decision. First few months might prove challenging, but eventually we will all educate ourselves on the rules of the pharmacist extension –pharmacy staff, surgery staff and patients.

Emma Burke, Advanced Nurse Practitioner in Respiratory at Galway University Hospitals and Virtual Care Lead for the Galway City Integrated Care Hub and Galway patient Frank O’Connell

Are we a nation locked into the stress-sleep cycle?

The global number of reported cases of adults affected by stress has seen an overwhelming increase since the pandemic. A study across 31 countries in 2023 saw a third (34%) of adults say stress has impacted their life multiple times in the last year and 27% say they have felt depressed on a number of occasions, where they couldn’t cope because of stress.1

Stress is usually a reaction to mental, physical or emotional pressure.2 In many everyday situations it can be seen as a normal reaction that helps keep us awake and alert, but when stress becomes excessive or persists over a period of time the opposite happens.

Dr Irshaad Ebrahim, co-founder of The London Sleep Centre and neuropsychiatrist, commented; “When our internal neuro-chemical systems are working normally, they regulate biological processes like sleep, appetite, mood and energy levels. If we are stressed, the Adreno-Cortical System is dysregulated and our energy sources are diverted, resulting in sleep disruption and mood changes. Before we sleep it’s important to de-stress, reducing levels of cortisol, and replacing them with increased levels of melatonin, the hormone released in the brain that signals to the body it’s time to sleep.”

The persistence of stress can in turn worsen our ability to sleep. As we continue to accrue a sleep deficit - the cumulative effect of not getting enough sleep,3 our ability to concentrate worsens, mood drops and productivity decreases, all of which can emphasise feelings of stress and anxiety.

Feeling stressed increases physiological and psychological arousal in ways that are incompatible with the conditions your body and mind need to enter a relaxed, restorative sleep. When this process repeats, a stresssleep cycle is formed. Dr Irshaad Ebrahim explains;

“The stress-sleep cycle is when feelings of stress stop you from achieving a sufficient night’s sleep, or when the thought of not achieving a good night’s sleep intensifies feelings of stress, thus exacerbating the cycle and making it harder to break.”

In order to break the cycle and improve the number of hours sleep achieved, and equally the quality

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of sleep obtained, we can make simple changes to our daily lives.

Sleep expert and neuropsychiatrist, Dr Irshaad Ebrahim comments; “I’m seeing a growing number of patients whose battle with achieving sufficient sleep is becoming increasingly harder. Managing feelings of angst is something we need to tackle in order to improve the quality of sleep achieved.

Here are 5 tips on how to break the stress-sleep cycle:

1. Ensuring consistency with a bedtime routine. Going to bed and waking up at the same time helps maintain the circadian rhythm – the body’s 24-hour internal clock.

2. Bright lights before bed can stimulate us, again interfering with a person’s circadian rhythm. Turning off your electronic

devices an hour before bedtime is a powerful intervention to assist sleep – go on try it for two weeks!

3. Using a herbal remedy can relieve stress and improve sleep. Valerian root is a popular choice that can be used to promote better sleep or simply to relax, depending on the quantities consumed. Traditional herbal remedies such as Kalms Night can be used to improve sleep without experiencing drowsiness the next day, while Kalms Day helps to relieve stress.

4. Reducing cortisol levels, and in-turn stress levels, before we go to bed is a must. Try 15 minutes of meditation or breathing exercises beforehand to help decrease anxiety and promote relaxation.

5. Physical activity is great for helping our body balance hormone levels, improving sleep and reducing stress. It’s a great way to release endorphins and other chemicals in the brain which reduce stress and regulate mood.”

References:

1. https://www.ipsos.com/en/ world-mental-health-day-2023

2. https://www2.hse.ie/ mentalhealth/issues/ stress/#:~:text=Stress%20 is%20usually%20a%20 reaction,relationships%20 difficulties

3. https://www.sleepfoundation. org/how-sleep-works/sleepdebt-and-catch-up-sleep

4. https://www.chemist-4-u.com/ sleep-study/

Axium Buying Group expand their Operations team, delivering best-in-industry customer service

Axium is Ireland’s largest buying group supporting independent pharmacies. Serving 560+ independent pharmacies with ~30% market share, Axium is built on the support of a best-in-class, energised and innovative team who are all focused on the same vision of making pharmacy life easier for their pharmacy business partners.

Axium is an established order management solution that provides speed and convenience to pharmacies when ordering dispensary medicines and consumables across a number of suppliers in the market, with the confidence that the products they are ordering are in stock at time of order, along with the best possible discount.

Business Intelligence reporting

Axium have significantly invested in iGnite, their Business Intelligence reporting solution. iGnite provides a pharmacy with significant savings by helping them analyse their lost opportunities for order savings, margin maximisation in dispensing behaviours and how to reduce claims errors.

Other benefits of iGnite BI reporting include:

Margin maximisation

- Monitoring ordering patterns

- Identifying lost margin

- Reviewing better margin options based on current dispensing

Pre-claims analysis

- Up-to-date potential claims losses

- Opportunity to fix issues before they’re submitted at month end

- Up-to-date with current PCRS guidelines for claiming

Post-claims analysis

- Identify partial payments from PCRS payments

- Identify losses due to claiming errors

Improving efficiency

Along with buying power and line level transparency on all purchases, one of Axium’s most attractive benefits is the improvement in operational efficiency it offers pharmacies.

Axium leverages advanced IT systems to streamline ordering processes, making it easier and more efficient for pharmacies to manage inventory, saving valuable staff time in the process. Axium supports customers with information in relation to upcoming manufacturer shortages

and recommended alternatives and have recently developed an electronic back-order feature to assist pharmacy teams in sourcing stock as soon as it becomes available after a shortage. Pack replacement ordering eliminates bulk buying, and all discounted and non-contract lines are set up on one platform, to provide a one stop ordering system. A customer testimonial touches on this;

“I particularly love the backorder facility, due to rising out of stock medication. The alerts option for back in stock products is a win/win for the business - excess stock isn’t ordered and staff time is minimised constantly searching for out of stock medicine. This way, our customers are not without their medicine and the business is not dispensing at a loss by supplying ULM.

I call it the “one stop shop”, as all can be purchased under the one frame ULM, Contract Lines, Ostomy and discounts applied.”Eleanor Hennelly McHale, MPSI. Staunton’s Pharmacy Castlebar.

Axium innovate by fostering a collaborative approach with their members. They are always open to taking feedback on board, understanding challenges their members may be faced with and putting solutions in place to make ordering easier, including in the case of stock outages, where a feature was developed based on feedback from pharmacies, so alternative lines are suggested. Saving this time for the team means more time put back into delivering high quality patient care.

Relationship management support & customer service

Axium prides itself on its high level of customer service, with a team of dedicated pharmacy technicians available to answer all your queries by phone from the Support Office, or online via an interactive chat function.

Axium understands the needs of busy pharmacies to receive the highest level of customer support, and have expanded their team on the road, all of whom have

many years of expertise and are well known in the world of community pharmacy.

The team, who regularly make face-to-face visits to Axium pharmacies, are dedicated to helping them achieve the highest

offering best-in industry levels of customer service.

Interested in joining Axium? email: customerservice@axium.ie

Using the latest, cutting-edge technologies to make dispensing to your patients reliable, safe & e cient.

Heathmail integration now live

Nursing Home module now available

• Unique intervention logging

• IHI (Individual Health Identiﬁer) number now recorded

To learn more or book a demo, get in touch on info@navi.ie or check out our website, navi.ie.

Pharmacy Taskforce

Pharmacists Welcome Taskforce Recommendations

Warnings that ambitious implementation and funding plan required

The Minister for Health Stephen Donnelly has published the report of the Expert Taskforce to Support the Expansion of the Role of Pharmacy.

Enabling pharmacists to prescribe for common conditions (often called minor ailments) means pharmacists can provide advice and treat common conditions.

This will enable pharmacists to manage common conditions by offering advice, and, when appropriate, prescribing prescription-only medicines through established protocols.

As recommended by the Taskforce an initial list of eight conditions will be included to allow pharmacists

working in a community pharmacy to provide treatment to patients:

1. Allergic Rhinitis (Inflammation of the inside of the nose caused by an allergen)

2. Cold Sores (Tiny, fluid-filled blisters on the face or genitals)

3. Conjunctivitis (An eye condition caused by infection or allergies)

4. Impetigo (A contagious skin infection)

Interim Chief Medical Officer Professor Mary Horgan, Minister for Health Stephen Donnelly and Chair of the Expert Taskforce Dr Pat O’Mahony at the final report of the Expert Taskforce to Support the Expansion of the Role of Pharmacy. The “radical report” comes on the back of the pharmacy sectors’ successful involvement in the covid-19 vaccine programme. Photo: Bryan Brophy/1IMAGE Photography

“As the global problem of medicines shortages continue, we look forward to the introduction of a serious shortage

protocol

which will

allow community pharmacists to source a clinically appropriate alternative in the event of a particular medicine being in short supply, thereby ensuring that the patient is looked

after in a timely manner”

“The introduction of a Common Clinical Conditions scheme could be among the most impactful changes in Irish Healthcare in decades. This will allow all people to access pharmacy care for minor conditions in the convenience of their pharmacy”

5. Oral Thrush (A fungal infection in the mouth)

6. Shingles (A skin infection caused by the chickenpox virus)

7. Uncomplicated UTI / Cystitis (An infection in the bladder or urethra)

8. Vulvovaginal Thrush (A genital fungal infection)

Pharmacists will be given the opportunity to undertake training to deliver this new service.

The Pharmaceutical Society of Ireland (PSI) will arrange for the delivery of this training which will delivered over the coming months. Patients will then be able to access treatment in a community pharmacy for these eight conditions to begin with.

Cautious Welcome

The Irish Pharmacy Union (IPU) has welcomed the recommendations of

the Expert Taskforce on the future of pharmacy services, stating that these recommendations when implemented could have a transformative effect on community healthcare. The IPU is now calling on the Minister for Health to realise this potential and agree to an ambitious implementation plan that adequately resources pharmacy care.

The Expert Taskforce made a total of 18 patient-focussed recommendations which when operational will provide significantly easier and quicker access for patients through the network of 1,900 community pharmacies across the country. The IPU has for many years been advocating for many of these changes particularly the introduction of a Common Clinical Conditions scheme.

Welcoming the recommendations, Tom Murray, President of the Irish Pharmacy Union said, “The

Tom Murray, President, Irish Pharmacy Union

Taskforce and Minister Donnelly are to be commended for getting the process to this stage however a lot of work still needs to be done before implementation can happen. This will require all stakeholders engaging in a collaborative way and agreeing the various protocols and addressing all funding issues.”

Highlighting initiatives that will deliver a significant benefit Mr Murray said, “The introduction of a Common Clinical Conditions scheme could be among the most impactful changes in Irish Healthcare in decades. This will allow all people to access pharmacy care for minor conditions in the convenience of their pharmacy.”

He went on to say, “As the global problem of medicines shortages continues, we look forward to the introduction of a serious shortage protocol which will allow community pharmacists to source a clinically appropriate alternative in the event of a particular medicine being in short supply, thereby ensuring that the patient is looked after in a timely manner.

“Extended prescribing is another initiative which should make matters more convenient and easier for patients,” Mr Murray added.

Pharmacy Engagement

Central to this is supporting the vision of Sláintecare where access to services is based on clinical need not ability to pay and equal access to healthcare. This requires a sustainable pharmacy service

and investment in pharmacy services is a key element to that.

Mr Murray said he now expects engagement with the Department of Health to progress these changes and the outstanding pay claim on the basis that there is an agreement that any new services and the pay claim would be dealt with in the round. “The IPU would recommend to members not to implement any new services until there was progress in respect of the pay claim,” he added.

“Community Pharmacists are effectively being paid less than they were in 2009 and the notion of layering on new schemes to an already underfunded and resourced group of healthcare professionals would not be credible, tenable or acceptable.”

Independent Pharmacist Prescribing

The Taskforce has also recommended the development of models of pharmacist prescribing across the health service. In other countries, this has involved pharmacists prescribing for more complex conditions in specific settings. The Minister has asked officials to examine how best to apply these models in an Irish context.

Minister Donnelly said:

“I established the Expert Taskforce to identify ways in which pharmacists can use their expertise to increase their already significant contribution to our healthcare service. Pharmacists are highly trusted, highly accessible and

“The report, which was contributed to by the PSI as members of and participants in the work of the Expert Taskforce, aligns with our commitment to ensuring pharmacy practice and policy is informed by evidence-based research. We also recognise and commend the important contribution of members of the public and patients in the work of the Expert Taskforce”

highly skilled. They’re In every town and village in Ireland. They are not yet being supported to work to their full potential.

“Today’s report was produced by experts including doctors, pharmacists, and other healthcare professionals. It provides an excellent roadmap for the further expansion of pharmacists’ roles.

“It recommends that we begin by supporting pharmacists to prescribe for certain conditions under a new Common Conditions Service. Various countries, including England, Scotland, Northern Ireland, Canada and New Zealand have already initiated pharmacist prescribing.

“I have written to a number of organisations, including the Pharmaceutical Society of Ireland and the Irish Pharmacy Union, to invite them onto an implementation group in order to ensure there is no delay in rolling out this service.

“What we are announcing today represents an important change. The move will also alleviate

Joanne Kissane, Registrar and Chief Officer, PSI

pressure on GPs. I want this Common Conditions Service to be in place in early 2025. The service will be scaled up over time, but we will start with these conditions.

“There is huge public support for this. My department conducted a public consultation on pharmacy in Ireland, and the feedback received was very encouraging, with 8 in 10 (83%) in favour of a Common Conditions Service.

“I would like to thank Dr O’Mahony and the Taskforce members for their work and huge commitment. I fully support the recommendations of the Taskforce.”

An Important Milestone

Speaking at the launch of the final report from the Expert Taskforce to Support the Expansion of the Role of Pharmacy, the Minister outlined the intent of strategic recommendations contained within the report to introduce full pharmacist prescribing authority, in a phased manner over the coming years.

pharmacists. This recommendation is proposed to be implemented in a step-wise manner, and will be dependent on several enablers including a legislative and regulatory framework and the development of dedicated postgraduate training.

The Pharmacy Regulator, has also welcomed announcement by the Minister for Health Stephen Donnelly T.D. to progress the phase two recommendations by the Expert Taskforce on expanding the scope of practice for pharmacists.

This will initially focus on the limited prescribing of prescriptiononly medicines by pharmacists under a common conditions service. Through this service, pharmacists will offer advice and treatment for common, often self-limiting conditions within community pharmacies. They will be authorised to prescribe and dispense prescription-only medicines for an approved list of common conditions that they are trained to diagnose and manage, enhancing access to timely care and reducing the burden on other healthcare providers, aligned to the principles of Slaintecare. To begin with, patients will have access to care for eight conditions* which can be extended over time as the service evolves in community pharmacies.

The Expert Taskforce** established in July 2023 by the Minister for Health was charged with considering and examining ways in which pharmacists can expand upon their present scope of practice, for the benefit of patients, the public and the wider health system.

This most recent announcement follows the adoption by Minister Donnelly of the first recommendation of the Expert Taskforce in November 2023, relating to prescription extension by pharmacists. The legislation to give effect to this first recommendation was enacted in March this year, with pharmacists enabled to extend prescriptions from 1 September, when in their professional judgement it is safe and appropriate to do so.

In the report, the Expert Taskforce has also provided other evidencedbased policy recommendations to the Minister, including the development of independent autonomous prescribing by

“We welcome the announcement by Minister Donnelly and the continued commitment to progress the recommendations in the final report from the Expert Taskforce,” said Joanne Kissane, Registrar and Chief Officer, PSI, and member of the Expert Taskforce. “These recommendations are another important milestone, providing clear policy direction and a roadmap for delivery of an expanded scope of practice for pharmacists, for the benefit of patients and the health system.

“It further reflects the important role that pharmacists, as medicine experts and healthcare professionals with a unique set of skills, can play as part of an integrated health care system.

“Today’s acceptance by Minister Donnelly of the report and the successful implementation of the recommendations contained therein, will contribute positively to improved patient outcomes, alleviate pressure within the health system, facilitate delivery of enhanced care both in community and hospital settings, and utilise to maximum effect, for patient and public good, the skills, training and accessibility of pharmacists.

“The report, which was contributed to by the PSI as members of and participants in the work of the Expert Taskforce, aligns with our commitment to ensuring pharmacy practice and policy is informed by evidence-based research. We also recognise and commend the important contribution of members of the public and patients in the work of the Expert Taskforce.

“As the regulatory body charged with protecting the health, safety and wellbeing of patients and the public by regulating pharmacists and pharmacies, the PSI’s focus is to ensure the necessary training, education, and regulatory supports are in place for pharmacists as an enhanced role and scope of practice is progressed for pharmacy.”

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Clinical Updates in Eczema Care

Atopic eczema (AE), also known as atopic dermatitis, is a chronic, inflammatory skin condition characterised by intense itch and recurring eczematous lesions. This common inflammatory skin disorder affects people of all ages and ethnicities, approximately affecting up to 20% of children and 10% of adults.

Presentation

Clinical presentation varies from mild to severe and depending on severity, symptoms can include severe dryness caused by a dysfunctional epidermal barrier, intense itching, cutaneous inflammation and vesicle formation. Atopic eczema symptoms have a chronic, or relapsing disease course.

Itch is a major symptom of AE, and scratching only provides temporary relief, and leads to more itching and scratching, which is often referred to as the ‘itch-scratchcycle’. The clinical appearance of AE may be modified by scratching, which in time may produce lichenification, broken skin surface resulting in excoriations, exudate and secondary infection. Appearance and location of eczematous lesions of AE may vary with age, and three stages have been recognised, infancy, childhood and adolescent/adult.

Cause and risk factors

The causes of this common inflammatory skin disease are complex, and comprises an interplay of genetics, immunologic and environmental triggers, that contribute to a skin barrier disruption and abnormal immune system response.

A strong risk factor for AE is a positive family history. The strongest known genetic risk factor in AE is associated with null mutations in filaggrin gene (FLG), which encodes a key epidermal structural protein filaggrin, which is necessary for skin barrier function.

Written by Michelle Greenwood, Health Promotion Manager, Irish Skin Foundation

The epidermis acts as a barrier, preventing water loss, as well as entry of foreign substances such as irritants, microbes and allergens. The epidermal barrier is made up of structural proteins including filaggrin (FLG). FLG deficiencies or mutations in the epidermis result in a weakened skin barrier, as it is less able to retain water, and the lipids that surround and support the cells break down more quickly. The impaired skin barrier allows loss of moisture and irritants or allergens to pass through the skin more easily. This can ultimately prompt an inflammatory cascade.

Triggers of AE may include, allergen exposure such as house dust mite, whereas, non-allergic factors such as Staphylococcus aureus infection, abrasive garments, temperature changes, stress, and exposure to irritants such as detergents, harsh soaps and fragrances and habitual scratching can disrupt the skin barrier function.

Assessment and management of atopic eczema

According to the UK Working Party diagnostic criteria, a diagnosis for AE requires: patients must have a history of itchy skin plus a minimum of 3 of the following;

• Flexural involvement, involving skin creases such as behind the knees, bends of elbows, wrists, front of ankles, or neck

• History of generally dry skin in the last 12 months

• Visible flexural eczema

• Personal history of asthma or hay fever (or history of atopic disease in a first degree relative, if patient is under 4 years)

• Onset of signs and symptoms in the first two years of life

Validated measures of severity in AE, include SCORing Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI) and

Patient Orientated Eczema Measure (POEM). Measurement techniques can be helpful in assessment, monitoring and guidance on effective management.

A really useful health-related quality of life measurement tool used in clinical practice is the Dermatology Life Quality Index (DLQI). This tool is not AE specific, however it helps clinicians to assess the impact of AE on the person’s life and assists the clinician to measure effectiveness of treatments. DLQI scores range from 0 (no impairment of quality of life) to 30 (maximum impairment). For children, there is the Children’s Dermatology Life Quality Index (CDLQI) which is also available with added cartoons. The aim of the questionnaire is to measure how much did the child’s skin condition affect them in the last week.

Once a diagnosis of AE is established, treatment decisions are based on disease activity and impact of the disease on the patient’s quality of life.

Management

AE is a life-long skin condition, so the main aim of treatment is to improve symptoms and achieve long-term control. Typically a multistep treatment approach may be considered, according to severity of the disease, patients age, its extent and distribution.

Key principals in AE management are: restoring the skin barrier with emollient therapy, baseline trigger avoidance, antiinflammatory treatment with topical steroids or topical calcineurin inhibitors. In moderate to severe AE, phototherapy or systemic agents may be considered.

Trigger avoidance and Topical treatments

Trigger avoidance: Taking a careful history to help identify any relationship between suspected triggers and AE skin symptoms is important. Identification, elimination and/or control of exacerbating triggers maybe helpful in preventing recurrent symptoms and disease deterioration. Irritants in the environment, such as physical (fabrics such as wool) household chemicals (bleaches or solvents) can aggravate

affected skin in people living with AE. Consideration for nonallergic triggers, may include, psychological stress, temperature extremes, and dry wintery or conditioned air.

Emollients: Ongoing, practical application of over-the-counter emollients is the cornerstone of treatment for the condition, as dry skin is one of the predominant manifestations of AE. The purpose of emollients is to improve the skin barrier by restoring and maintaining skin hydration, therefore soothing the skin and reducing pruritus. Emollients are also a crucial element of maintenance treatment and also in the prevention of flares. Adults require at least 500g/ per week and children at least 250g/ per week. Pump dispensers are preferable, in order to prevent contamination. The use of emollient wash products instead of ordinary soaps and bubble baths are also recommended. Bathing should be limited to short periods of time (e.g. 5-10 minutes) with warm water, and when finished, followed by application of emollients. When choosing an emollient, individual preference, skin type, skin dryness, inflammation and body area may be considered to help promote adherence.

In July 2020 the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, in partnership with the National Fire Chiefs Council, launched a campaign to raise awareness around the potential fire risks of emollients (moisturisers) often used in the management of skin disease.

The British Association of Dermatologists (BAD) released a statement on their website in July 2020 on fire risk associated with emollient use. According to the BAD “emollients represent a safe treatment option, for most patients. That said, it is important that patients, carers, and healthcare professionals are aware of the potential fire risks associated with these products, and how to minimise them. It is important to stress that emollients are not flammable in themselves, nor when they are on the skin. The risk comes when emollient residue dries onto fabrics such as clothing or bedding and then comes into contact with a naked flame or lit cigarette causing them to catch fire.

Capasal Therapeutic Shampoo

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

Capasal™ Therapeutic Shampoo

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

Uses: As a shampoo in the treatment of dry, scaly scalp conditions such as seborrhoeic eczema, seborrhoeic dermatitis, pityriasis capitis, psoriasis and cradle cap in children. It may also be used to remove previous scalp applications.

Contra-indications, warnings, side e ects etc: Please refer to SPC for full details before prescribing. Do not use if sensitive to any of the ingredients. In case of irritation or if there is no improvement a er 4 weeks, or the condition is aggravated, discontinue treatment. Keep away from the eyes. Keep out of the reach of children. Use in pregnancy: avoid use during rst trimester.

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

Legal category: Supply through pharmacy only.

Further information is available from: Dermal Laboratories (Ireland) Ltd, Head O ce Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK.

Date of preparation: June 2024. ‘Capasal’ is a trademark.

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

Prescribing information www.dermal.ie

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

Eczema

To reduce the fire risk, patients using these products are advised to avoid naked flames completely, including smoking cigarettes and being near people who are smoking or using naked flames. It is also advisable to wash clothing and bed linen regularly.”

Wet-wrap therapy: This is a technique used in people with moderate to severe eczema by using two layers of open-weave tubular bandage applied over emollients. The bottom layer is soaked in warm water, squeezed out and then put onto the skin over the emollient wet and then followed by the top layer which is dry. This treatment is reported to introduce moisture, soothe and protect irritated skin from damage caused by scratching and is applied for short periods of time. Caution should be taken when wet wrapping using topical steroids, as absorption is increased. Occlusive medicated dressings or dry bandages should not be used in infected AE.

Topical corticosteroids:

Recognised as first-line antiinflammatory prescribed treatments in acute exacerbations. Selection of agent varies depending on potency, the location and severity of skin affected by AE, patient age and formulation. Topical corticosteroids are grouped into classes depending on their potency, ranging from mild, moderate, potent and very potent. A fingertip unit (FTU) is a useful method for individuals to apply topical corticosteroid in safe quantities. A FTU refers to the amount of ointment or cream applied from the end of an adult index fingertip, to the distal crease (first joint) in the finger, and is equivalent to approximately 0.5grams. The recommended FTU of topical corticosteroid will depend on the part of the body

being treated and whether the patient is an adult or child. The Irish Skin Foundation has a useful guide describing the number of FTU’s required for different parts of the body in adults and children in the eczema booklet on https:// irishskin.ie/eczema/.

Topical calcineurin inhibitors (TCI): Considered as a secondline option for short-term and intermittent treatment of AE. These prescribed non steroidal, antiinflammatory agents do not cause skin atrophy, and are beneficial in treating sensitive skin areas such as the face and groin. Stinging on application is the most common side-effect, but this usually settles within a few days, also sun protection is advised, in patients treated with TCI.

Phototherapy

Phototherapy is a form of artificial ultraviolet light treatment, comprised of either ultraviolet A (UVA) or ultraviolet B (UVB) wavelengths of light, delivered in hospital dermatology day care centres. Phototherapy may be given in combination with topical steroids and emollients to prevent flare-up.

Systemic agents

In circumstances where AE is moderate to severe or widespread, and has not responded to topical or phototherapy treatments or when quality of life is significantly impacted, systemic immunosuppressive treatments may be prescribed. Current options include, methotrexate, ciclosporin, mycophenolate mofetil, and azathioprine. The individual patient profile, lifestyle factors, associated comorbidities, side effect profile along with patient preference all influence choice of drug. These medications have different toxicity profiles,

therefore patients are reviewed and monitored regularly to avoid any potential side effects.

Newer systemic agents which can be prescribed in secondary care for patients with moderate to severe AE, through the HSE managed access programme include; abrocitinib (Cibinqo®), dupilumab (Dupixent®), tralokinumab (Adtralza®) and upadacitinib (RINVOQ®). These agents are available to patients that meet a certain criteria set out by the Managed Access Protocol and prescribing is confined to consultant dermatologists.

AE associated infections

AE is often complicated by bacterial, viral and fungal infections, due to a weakened skin barrier, trauma from scratching and impaired cellular immunity.

Staphylococcus aureus, is the most common organism, to cause bacterial infection in AE. Distinctive signs may include honey-coloured crusts, weeping and pustules, and folliculitis in hair-bearing areas.

Topical or oral antimicrobials may be prescribed. Common viral Infections seen in individuals with AE include molluscum contagiosum, cutaneous warts and herpes simplex virus.

Itch

AE is often referred to as the “itch that rashes” due to the pruritus that patients with AE often experience. The urge to scratch can be overwhelming but only provides temporary relief, leading to more itching and scratching (the itch-scratch cycle) which may lead to excoriation and skin barrier damage. Itch interferes with sleep and negatively impacts on an individual’s quality of life, as well as that of the wider family, with sleep deprivation contributing to difficulties concentrating at

school, and/or work. Sufficient sleep is crucial for health and well-being. In children, both acute and chronic sleep disruption has been associated with a range of ‘cognitive, mood and behavioural impairments’, as well as poor performance in school. In a ISF ‘Living with Atopic Eczema Survey’ in 2019, respondents reported interrupted/ loss of sleep in 86% of children and 84% of adults. Additionally, 26% of carers of children with AE, reported that their child missed 1-2 days of school per month due to their skin condition.

Quality of life

For some, the burden of AE often extends beyond the immediate dermatological effects of this disease. AE can place a serious mental health burden on patients, particularly those living with moderate-to-severe disease, with research indicating that the more severe the AE, the more quality of life is impacted. It has been associated with anxiety, depression and attention deficit hyperactivity disorder. Research has indicated that the health related quality of life in children with AE is comparable to that of other chronic childhood diseases such as diabetes or asthma.

Conclusion

AE is often associated as a disease of childhood, but it is important not to forget that AE can be a very distressing condition for adults as well. While severity of AE varies greatly, most are affected by mild disease. Due to a variety of treatments for AE and different individual symptoms, it is important to educate patients and their families about the disease, and selfcare to ensure compliance and effective management. These include, basic skin care routines that fits in with the individual’s lifestyle, management of future flares and trigger avoidance. Also consideration around any potential fears with regards to side-effects of medications such as topical steroids should be addressed, as this may impede sufficient treatment. Education for self-managing AE, are reported to improve the severity of the disease and also improve the quality of life for these individuals and their carers.

The Irish Skin Foundation operates a Ask-a-Nurse Helpline that provides free, direct, accessible and specialist guidance about skin conditions, delivered by dermatology clinical nurse specialists on an appointment model.

For information on eczema or other skin conditions log onto www.irishskin.ie

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Supporting Women to Love Their Hearts

September is Irish Heart Month, and this year the focus is on ‘Her Heart Matters’ – A campaign highlighting the importance of women’s heart health, particularly in midlife.

Community pharmacy is at the ‘heart’ of women’s health and there is a plethora of support and advice pharmacy teams can give. Already helping millions of women every day, pharmacies have a unique role to play during this important campaign.

In recent years, there has been a welcome focus in the national conversation around women’s health issues, be it reproductive health, menopause, or cancer screening. However, there has been a glaring gap. One in four women dies from heart disease and stroke each year – the same as men and, incredibly, six times more than die from breast cancer. That’s over 4,000 mothers, daughters and sisters each year in Ireland. There is a false belief that cardiovascular disease (CVD) is a man’s disease but there are many female-specific factors that affect a woman’s risk, including menopause and hypertensive disorders of pregnancy. However, the good news is that 80% of premature heart disease and stroke is preventable through healthy lifestyles.

But too many women aren’t aware of these facts and many health professionals are also missing these important messages.

According to the Lancet Women and Cardiovascular Disease Commission, heart disease and stroke in women has been under-researched, underdiagnosed and under-treated.

• under-researched (women have been left out of clinical trials)

• under-diagnosed (women often present with more unusual signs of CVD and can receive an incorrect diagnosis. Rather than the classic version of a heart attack where someone is seen clutching their chest, the symptoms of a heart attack in women can be quite vague making it hard to diagnose. They can include nausea, tiredness, shortness of breath, back pain or tightness in the jaw rather than the more familiar scenario of a crushing pain in the chest that shoots down one arm).

• under-treated (women can be under-treated or treatment can be delayed if they are under-diagnosed. Many treatments are made for men and not adequately researched in women).

There are a number of advice points pharmacy teams can employ to help women take better care of their heart health.

Mindset

Getting into the right frame of mind is essential for change. Women need to feel ready and have clear, powerful reasons for making a change. As part of the Her Heart Matters campaign, the Irish Heart Foundation has created a free Self-Care and Wellbeing Journal to support women to reflect on their lifestyle habits and prepare for meaningful change.

Stress

While stress is a normal part of life, it can be negative when it starts to impact day to day tasks. Many women are juggling multiple demands, and this can be particularly challenging during menopause. Advise them to try to keep a regular sleep routine, be physically active and stay connected to friends and family. If they are struggling, they should contact their GP.

Physical Activity

Regular physical activity is one of the greatest tools for preventing heart disease and stroke as well as helping to reduce some menopause symptoms. Getting at least 150 minutes a week of moderate-intensity activity is recommended for good health. This can be broken down into three 10 minute sessions. They should try to add muscle-strengthening exercises too.

Nourishing your Heart

Research shows that a Mediterranean-style diet can help to reduce heart disease and stroke and help manage menopause symptoms. Like the Irish Food Pyramid, a Mediterranean-style

diet is based around fruit and vegetables, whole grains, beans and other pulses, nuts, and seeds. It includes some olive oil, fish, seafood, and poultry, and is low in sugar, salt, processed foods, and red meat.

Start the Conversation

Be part of the movement of women and men who want to see change and protect all women from one of Ireland’s biggest killers. Talk with your sisters, mothers, daughters, and friends, share the campaign with them, and empower them to make changes.

What can women do?

Diet can play a major role in modifying the risk for CVD, women should focus on what they can add to their diets to make it more heart healthy.

One of the most important things is to focus on following a consistent healthy dietary pattern, one in line with the Mediterranean style of eating. This contains protein sources mainly from plants, nuts, fish, or alternative sources of omega-3 fatty acids; fat mostly from unsaturated plant sources; carbohydrates primarily from whole grains; at least five to seven servings of fruits and vegetables per day; and moderate dairy consumption.

Omega-3 fatty acids are polyunsaturated fats that are beneficial for heart health. Eicosapentaenoic acid (EPA), docosahexaenoic acids (DHA) and alpha-linolenic acid (ALA) are the three main omega-3 fats. As a group, omega-3’s lower blood triglyceride levels, slow the growth of plaque in arteries and have a slight effect on lowering blood pressure. EPA and DHA are found mainly in oily fish and should be consumed once or twice per week. ALA needs to be converted

from ALA to EPA and DHA, but this happens at very slow rates, which means ALA food sources like flaxseed, olive oil, walnuts and avocado need to be consumed daily. Women who completely avoid these food sources or have raised triglyceride levels may benefit from omega-3 supplements with EPA and DHA, 200 to 500mg a day of combined EPA and DHA.

Saturated fats coming from fatty meats, butter, lard, palm oil and coconut oil, as well as cakes, biscuits, pies and pastries need to be reduced to prevent the elevation of LDL levels, which promote plaque build-up in the arteries. Ideally less than 10% of total daily calories should come from saturated fat.

The Role of CoQ10

CoQ10, also known as coenzyme Q10, is a naturally occurring nutrient found in every cell of our bodies. It’s a vital component of our cellular machinery, playing a key role in the production of energy. This compound is synthesised within our cells’ powerhouses, the mitochondria, where it aids in the creation of adenosine triphosphate (ATP), the primary energy source for our cells. CoQ10, a vitamin-like compound, has been linked to potential benefits for heart health. It’s been studied for its potential to improve conditions such as heart failure, atherosclerosis, and coronary artery disease. The high energy requirements of cardiac cells make them particularly susceptible to low levels of CoQ10, which is where supplementation may come into play.

Research suggests that CoQ10 may support heart health by reducing oxidative stress, a factor that can contribute to heart disease. It’s also been found to potentially aid recovery after heart attacks, easing symptoms of heart failure, and helping to regulate blood pressure.

Suppor t i ng energy a nd hear t hea lth

From Pharmacies Nationwide

*Contains Thiamine which contributes to the normal function of the heart, and to normal energy-yielding metabolism

Why this compound is so important for your heart

Coenzyme Q10 is a vitamin-like nutrient that has been shown in multiple studies to improve cardiac function and help those suffering from chronic heart failure.

The human heart contracts around 10,000 times each day on average. That requires a generous amount of energy. For a young and healthy person, this is no problem. However, with increasing age, different factors can interfere with the heart muscle’s ability to contract. There is the inevitable, age-related and gradual loss of heart power, which explains why someone aged 75 is not able to run as fast as a 30-year-old. But the disease can also affect the heart. Some people develop chronic heart failure, a potentially debilitating condition that can reach a stage where it gets in the way of ordinary daily activities.

“Energy-starved” heart

Heart failure is often referred to by cardiologists as having an “energy-starved heart”. This is a very accurate description because the heart is simply unable to generate the amount of energy needed to contract with sufficient force to pump blood through the cardiovascular system. What science has discovered, however, is that energy shortage can be helped with the vitamin-like compound coenzyme Q10. All cells need coenzyme Q10 to convert fat, carbohydrate, and protein into ATP (adenosine triphosphate), which is energy stored in its biochemical form. The body produces the compound endogenously, but this synthesis begins to taper off in our midtwenties. Our cellular levels of coenzyme Q10 can also be diminished by different types of disease. Heart muscle biopsies have revealed that people with chronic heart failure have depleted coenzyme Q10 levels, but this can be corrected with a coenzyme Q10 supplement in capsule form.

Helped sufferers of chronic heart failure

In 2014, a study (Q-Symbio)1 was published in JAAC Heart Failure, in which 420 patients with chronic heart failure had been randomly assigned to either daily supplementation with 300 mg of pharmaceutical-grade coenzyme Q10 or matching placebo. After two years, the heart-related mortality rate in the active treatment group had decreased by 43 percent compared with the placebo group. Also, people in the Q10 group

showed signs of improved quality of life, and they had a significantly lower hospitalisation rate and substantially fewer major adverse cardiovascular events (MACE) compared with the placebo group.

54 percent lower mortality rate

Another study2, which was published in the International Journal of Cardiology in 2013, was conducted on 443 healthy seniors aged 70-88 years. In this double-blind, placebo-controlled intervention trial, participants were randomly assigned to daily supplementation with coenzyme Q10 (200 mg) and selenium yeast (200 mcg) or matching placebo. After four years, the cardiovascular mortality rate in the active treatment group had dropped by 54 percent compared with the placebo group. In addition, heart muscle function had improved significantly.

A powerful antioxidant

Besides its essential role in cellular energy metabolism, coenzyme Q10 is a powerful antioxidant. This is also highly relevant for its role in cardiovascular protection. The compound effectively prevents free radicals from attacking and oxidizing blood lipids such as

cholesterol, thereby counteracting the inflammatory process in the blood vessel endothelium that eventually leads to atherosclerosis.

While we are on the topic of cholesterol, it is relevant to mention that cholesterol-lowering statins have been shown to reduce levels of coenzyme Q10 in the body. Both cholesterol and coenzyme Q10 are downstream products of the same biochemical pathway (the mevalonate pathway). By blocking this pathway, statins interfere with the body’s coenzyme Q10 synthesis. The impaired Q10 synthesis causes dysfunctions in the cellular powerhouses (the mitochondria), which is believed to be one of the reasons why statins can cause side effects such as aching muscles.

Counteracts side effects of statins

Studies have demonstrated that this problem can be prevented by taking coenzyme Q10 in combination with the statin drug. In a study3 published in American Journal of Cardiology, the administration of coenzyme Q10 (100 mg daily) in combination with statin therapy reduced muscle pains by around 40 percent. Other studies have shown similar results.

Overall, studies point to coenzyme Q10 as having a key role in cardiovascular health. The compound is needed for a sufficient cardiac output, and supplementation with coenzyme Q10 can be useful for compensating for the age-related loss of heart power and improving the condition of patients suffering from heart failure.

References:

1 Cardiovascular mortality and N-terminal-proBNP reduced after combined selenium and coenzyme Q10 supplementation: A 5-year prospective randomized doubleblind placebo-controlled trial. Int J Cardiol. 2013;167: 1860-1866.

2 The Effect of Coenzyme Q10 on Morbidity and Mortality in Chronic Heart Failure: Results From Q-SYMBIO: A Randomized Double-Blind Trial

JACC: Heart Failure, Volume 2, Issue 6, December 2014, Pages 641-649

3 Effect of coenzyme q10 on myopathic symptoms in patients treated with statins

American Journal of Cardiology, 2007 May 15;99(10):1409-12.

RCSI MyHealth

RCSI has launched the 2024/25 programme for RCSI MyHealth, an initiative that aims to bring reliable and trustworthy healthcare information to the public.

This year, the programme will feature in-person events offering the public the unique opportunity to engage directly with RCSI experts at our live sessions, as well as our popular online episodes.

The upcoming series will explore important health topics starting with the emotional impact of a dementia diagnosis and practical ways to maintain brain health, followed by the management of chronic pain and mental health. The third episode, focusing on emotional well-being following a cancer diagnosis, will take place as an in-person event at RCSI’s St Stephen’s Green campus in Dublin city centre.

In 2025, the series will address changing sleep patterns throughout life, best practices in diabetes management and the importance of clean air for health. The episodes are for anyone wanting to learn about common illnesses and healthrelated topics directly from leading healthcare experts and explore a wide range of areas in health and well-being.

The upcoming episodes of the 2024 RCSI MyHealth series are:

• 19 September: Dementia and maintaining a healthy brain for life

• 17 October: Understanding and managing chronic pain

• 13 November: In-person event: “I don’t know how to feel” – Coping strategies for life with cancer

Chaired by Professor Annie Curtis, Associate Professor in RCSI’s School of Pharmacy and Biomolecular Sciences, panelists will include Professor Alan Moore, Consultant Geriatrician, Beaumont Hospital and Honorary Clinical Lecturer, RCSI, Professor Norman Delanty, Consultant Neurologist, FutureNeuro Research Centre Clinical Investigator and RCSI Honorary Clinical Professor and Ms Kathleen Farrell, patient advocate for people living with dementia.

For more information, to subscribe to the mailing list or to register for any of the upcoming lectures visit the MyHealth Lecture Series webpage.

LloydsPharmacy Rebrands and Opens First McCabes Pharmacy Move

Sparks National Rollout

Last month marked the first step in McCabes Pharmacy’s journey to becoming Ireland’s largest and most patient-centric pharmacy brand with the official rebranding of their LloydsPharmacy, Ashleaf store in Dublin to McCabes Pharmacy - the first of many to follow.

Joining the celebrations and to help cut the ribbon of the newly rebranded McCabes Pharmacy

Sharon McCabe, CEO of McCabes Pharmacy, Karen Doherty, General Manager, Jan Pieter Hallema, Managing Director LloydsPharmacy and Brian

O’Keeffe, Retail Director along with the Ashleaf Pharmacy team

The Ashleaf Shopping Centre in Crumlin was energised with excitement this morning with the official rebranding of the store which saw cheers from the pharmacy team and members of the community. An official ribbon-cutting took place, marking the beginning of a new era in community pharmacy care as McCabes Pharmacy expands its footprint with 112 stores employing 1,400 people.

In the coming months, a further 79 pharmacies across Ireland will undergo rebranding across many counties, stretching the length and breadth of Ireland from Letterkenny, to Sligo to Kenmare, Limerick, Wexford, and Dublin.

Both LloydsPharmacy and McCabes Pharmacy teams are uniting under the McCabes name with the objective of creating a stronger, more resilient pharmacy network that puts patients at the heart of everything, aiming to provide exceptional care and an enhancement of services to reflect evolving healthcare needs - including the rise of digital health, a focus on personalised and preventative care, and the expanding role of pharmacies in providing integrated health services.

Joining the celebrations and to help cut the ribbon of the newly rebranded McCabes Pharmacy Sharon McCabe, CEO of McCabes Pharmacy, Karen Doherty, General Manager, Jan Pieter Hallema, Managing Director LloydsPharmacy and Brian O’Keeffe, Retail Director along with the Ashleaf Pharmacy team.

Sharon McCabe, CEO of McCabes Pharmacy, said, “Today marks a new chapter for McCabes Pharmacy as we extend our renowned patient care to locations right across Ireland. By coming together under the McCabes Pharmacy name, we are not only expanding our reach and becoming more accessible to our patients but becoming the leading pharmacy services provider in Ireland the opportunities this rebranding brings as we become Ireland’s leading Pharmacy brand with 112 pharmacies. We also are excited that we can now bring our successful MccabesPharmacy. com and app offering to customers across the country which boosts excellent customer ratings for service including next-day delivery and click-and-collect.”

Jan Pieter Hallema, Managing Director LloydsPharmacy, added, “Whilst our patients will still see the same familiar faces from the teams they know and trust, this new more resilient pharmacy network combines the strengths of both

brands allowing us to enhance our services and continue to meet the evolving needs of our customers.”

The rebrand is well underway and customers will start to see the McCabes Pharmacy name on stores over the coming months and expected to be fully branded by end of December. Prescriptions and medication orders will not be affected, and service will continue as usual with the same dedicated pharmacy teams providing their patients with a high standard of care and advice.

McCabes Pharmacy is committed to providing top-tier healthcare services across Ireland. With a focus on personalised patient care, and digital know how, McCabes Pharmacy continues to set the standard for excellence in the retail pharmacy sector.

Sharon McCabe, CEO of McCabes Pharmacy with Jan Pieter Hallema, Managing Director LloydsPharmacy and Brian O’Keeffe, Retail Director

Consultant in Pain Management & Neuromodulation,

Clinical Director Mater Private Hospital, Cork

Associate Professor of Pain Medicine, UCC, Ireland

Honorary Consultant Guy's & St. Thomas' Hospital, London

Clinical Lead Neuromodulation Research, Tyndall National Institute, UCC

President World Institute Of Pain (WIP)

Clinical Director Pain Relief Ireland www.painreliefireland.ie

Topical Analgesics in the Management of Acute & Chronic Pain

Ref

The use of topical analgesics can offer a potentially valuable strategy in the management of a variety of conditions associated with acute or chronic pain, including acute soft tissue injuries, chronic musculoskeletal pain, and various neuropathic pain disorders. Initially, they were developed to provide symptomatic benefits without the systemic adverse effects (AEs) associated with their oral counterparts. They can produce clinically effective drug concentrations at a peripherally located site of injury or inflammation, without resulting in high systemic concentrations that may increase the likelihood of AEs. They probably get unfairly criticised because of irregular and inadequate application.

In this overview, we have restricted our scope to non-opioid drugs that are applied to intact skin, which is the situation where topical analgesics are most frequently used outside special circumstances. The reader is directed to Derry et al. 2017 for the Cochrane review.

How do topical analgesics work?

For a topical formulation to be effective, it must first pass through the skin at or near the injury site. Individual drugs have different degrees of penetration, and some formulations add substances that improve skin penetration and result in higher drug concentrations in tissues. The balance between lipid and aqueous solubility is used to optimise penetration. The use of prodrug esters has been suggested as a way of enhancing permeability. Experiments with artificial membranes or human epidermis suggest that creams are generally less effective than gels or sprays, but newer formulations such as microemulsions may have greater potential. More recently the use of a patch system to deliver the product can increase the opportunity to penetrate the skin over time.

Professor Dominic A. Hegarty

Consultant in Pain Management & Neuromodulation, Clinical Director Mater Private Hospital, Cork

Associate Professor of Pain Medicine, UCC, Ireland

Derry S, Wi en PJ, Kalso EA, Bell RF, Aldington D, Phillips T, Gaskell H, Moore RA. Topical analgesics acute and chronic pain in adults - an overview of Cochrane Reviews. Cochrane Database of Systematic 2017, Issue 5. Art. No.: CD008609. DOI: 10.1002/14651858.CD008609.pub2

Argoff C. Topical Analgesics in the Management of Acute and Chronic Pain Mayo Clin Proc. n February 2013;88(2):195-205 n http://dx.doi.org/10.1016/j.mayocp.2012.11.015

Topical NSAIDs

Description of the interventions

A number of different topical analgesics have been tested in a wide range of different painful conditions. The scope of this overview covers several possible interventions.

Non-steroidal anti-inflammatory medication (NSAIDs) reversibly inhibit the enzyme cyclooxygenase (prostaglandin endoperoxide synthase or COX), now recognised to consist of two isoforms, COX-1 and COX-2, mediating production of prostaglandins and thromboxane A2. Inhibition of the COX-2 format reduces inflammation and produces analgesic effects.

Description of the interventions

use of a patch system to deliver the product can increase the opportunity to penetrate the skin over time.

The rationale behind topical application is based on the ability of NSAIDs to inhibit COX enzymes locally and peripherally, with minimum systemic uptake. Their use is therefore limited to conditions where the pain is superficial and localised, such as in joints and skeletal muscle.

Once the drug has reached the site of action, it must be present at a sufficiently high concentration to inhibit COX enzymes and produce pain relief. It is probable that topical NSAIDs exert their action by local reduction of symptoms arising from periarticular and intracapsular structures. Tissue levels of NSAIDs applied topically certainly reach levels high enough to inhibit COX-2. Plasma concentrations found after topical administration, however, are only a fraction (usually much less than 5%) of the levels found in plasma following oral administration. Topical application can potentially limit systemic adverse events by minimising systemic concentrations of the drug. Current guidelines in the UK encourage

A number of different topical analgesics have been tested in a wide range of different painful conditions. The scope of this overview covers several possible interventions.

Table 1 Indications for topical analgesics

• For strains and sprains, topical nonsteroidal anti-inflammatory drugs (NSAIDs) or topical rubefacients.

• For osteoarthritis, topical NSAIDs, topical rubefacients, and low concentration topical capsaicin.

• For neuropathic pain, topical local anaesthetic (lidocaine, for example) or high-concentration topical capsaicin.

• Topical herbal medicines have been used for a variety of painful conditions.

TOPICAL ANALGEICS FOR PAIN MANAGEMENT

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

use of topical NSAIDs ahead of oral agents where possible.

Topical capsaicin

Capsaicin is the active compound present in chili peppers, responsible for making them hot when eaten. It binds to nociceptors (sensory receptors responsible for sending signals that cause the perception of pain) in the skin, and specifically to the TRPV1 receptor, which controls movement of sodium and calcium ions across the cell membrane. Initially, binding opens the ion channel (influx of sodium and calcium ions), causing depolarisation and the production of action potentials, which are usually perceived as itching, pricking, or burning sensations.

Repeated applications or high concentrations give rise to a long-lasting effect, which has been termed desensitisation, probably owing to a number of different effects that together overwhelm the cell’s normal functions and can lead to reversible degeneration of nerve terminals.

Topical creams with lowconcentration capsaicin designed for repeated applications are used to treat pain from a wide range of chronic conditions including postherpetic neuralgia (PHN), peripheral diabetic neuropathy (PDN), osteoarthritis and rheumatoid arthritis, in addition to pruritus and psoriasis. The creams typically contain capsaicin 0.025% or 0.075%, but in some countries 0.25% creams are available

A high-concentration (8%) patch has been developed to increase the amount and speed of delivery of capsaicin to the skin and improve tolerability. Rapid delivery is thought to improve tolerability because cutaneous nociceptors are desensitisation quickly, and the single application avoids both noncompliance and contamination of the home environment with particles of dried capsaicin cream (Anand 2011). The highconcentration product is a single

application with a minimum interval of 3 months, performed in a clinic, with cooling, local anaesthesia or short-acting opioids to reduce local pain on application. Patients are usually monitored for up to two hours after treatment.

Stringent conditions are required, and as well as using trained healthcare professionals, the treatment setting needs to be well ventilated and spacious due to the vapour of the capsaicin, and cough due to inhalation of capsaicin particles/dust is a hazard for both the healthcare professionals and the patients.

High-concentration capsaicin is licensed in the European Union (EU) to treat neuropathic pain, and in the USA to treat peripheral postherpetic neuralgia. It is available on prescription only; it was licensed in 2009 in Europe and the USA. The US Food and Drug Administration (FDA) refused a licence for neuropathic pain in HIV in 2012. The EU

licence originally restricted use to non-diabetic patients, but this restriction was lifted in 2015.

Topical lidocaine

Topical lidocaine dampens peripheral nociceptor sensitisation and central nervous system hyperexcitability if used in recommended doses. It may benefit people with PHN or traumatic nerve injury, where its lack of systemic side effects makes it an attractive option. As cream and gel, lidocaine is cumbersome to administer. The patch is more convenient, being worn for 12 hours in every 24 hours. In addition to the local anaesthetic effect, the patch provides protection against mechanical stimulation (dynamic allodynia), which is a frequent problem in PHN.

Lidocaine is an amide-type local anaesthetic agent that acts by stabilising neuronal membranes. It impairs membrane permeability to sodium, which in turn blocks impulse propagation, and thus dampens both peripheral nociceptor sensitisation, and eventually central nervous system hyperexcitability. It also suppresses neuronal discharge in A delta and C fibres. Regenerating nerve fibres have an accumulation of sodium channels. When lidocaine binds to such sodium channels it initiates an ‘inactive state’ from which normal activation is unable to occur. Lidocaine reduces the frequency rather than the duration of sodium channel opening. In a small dose it inhibits ectopic discharges, although it does not disrupt normal neuronal function. Lidocaine also suppresses

Table 2: Summary of Number Needed to Treat (NNT) for topical anti-inflammatory products in acute pain

spontaneous impulse generation from dorsal root ganglia, where the herpes virus remains dormant after initial infection by Varicella zoster (chickenpox)

Other effects on keratinocytes and immune cells, or activation of irritant receptors (TRPV1 and TRPA1), may also contribute to the analgesic effect of topical lidocaine (Long-term use may cause a loss of epidermal nerve fibres.

Expected outcomes

In acute musculoskeletal pain (strains and sprains) with assessment at about seven days, therapies were diclofenac Emulgel (78% Emulgel, 20% placebo; 2 studies, 314 participants, NNT 1.8 (95% confidence interval 1.5 to 2.1)), ketoprofen gel (72% ketoprofen, 33% placebo, 5 studies, 348 participants, NNT 2.5 (2.0 to 3.4)), piroxicam gel (70% piroxicam, 47% placebo, 3 studies, 522 participants, NNT 4.4 (3.2 to 6.9)), diclofenac Flector plaster (63% Flector, 41% placebo, 4 studies, 1030 participants, NNT 4.7 (3.7 to 6.5)), and diclofenac other plaster (88% diclofenac plaster, 57% placebo, 3 studies, 474 participants, NNT 3.2 (2.6 to 4.2)).

In chronic musculoskeletal pain (mainly hand and knee osteoarthritis) therapies were topical diclofenac preparations for less than six weeks (43% diclofenac, 23% placebo, 5 studies, 732 participants, NNT 5.0 (3.7 to 7.4)), ketoprofen over 6 to 12 weeks (63% ketoprofen, 48% placebo, 4 studies, 2573 participants, NNT 6.9 (5.4 to 9.3)), and topical

Table 2 Summary of the Number Needed to Treat (NNT) NSAID (to achieve 50% improvement compared to placebo for NSAIDS) Agent

Not all topical diclofenac products are the same. Formulation Matters.1

Voltarol Emulgel Extra Strength Gel is clinically proven to demonstrate deep tissue penetration into the joint 2

For all-day relief from joint pain†

Learn more about the formulation of Voltarol Emulgel Extra Strength Gel

† apply once, morning & evening

References: 1. Derry S et al. Cochrane Database Syst Rev 2015; 6: CD007402. 2. Seefried et al. Ther Adv Musculoskel Dis (2020) Vol 12: 1-13.

Product Information: Please consult the Summary of Product Characteristics for full product information.

Voltarol Emulgel 1% w/w Gel (diclofenac) and Voltarol Emulgel Extra Strength 2% w/w Gel (diclofenac). Indications: For the local symptomatic relief of pain and inflammation in trauma of tendons, ligaments, muscles and joints, localised forms of soft tissue rheumatism. Dosage: Adults and adolescents 14 years and over: Voltarol Emulgel 1% w/w Gel: 2-4g of gel, applied topically 3-4 times daily. Maximum treatment duration is 7 days. Voltarol Emulgel Extra Strength 2% w/w Gel: 2-4g of gel, applied topically 2 times daily – morning and evening. Maximum treatment duration is 14 days. All gels: Patients should consult their doctor if the condition does not improve within 7 days, or worsens. Contraindications: Patients with or without chronic asthma in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents. Hypersensitivity to diclofenac, acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, or any other ingredient in the gel. Use in third trimester of pregnancy. Use in children and adolescents aged less than 14 years. Warnings and precautions: Apply only to intact, non-diseased skin and not to skin wounds or open injuries. Do not smoke and avoid naked flames. It should not be used with occlusion, allowed to come into contact with the eyes or mucous membranes or ingested. Application over extensive areas for prolonged periods or application in excess of recommended dosage may give rise to systemic effects. Discontinue if rash develops. Use with caution in patients with a history of peptic ulcers, gastrointestinal bleeding, hepatic or renal insufficiency, or bleeding diathesis, or intestinal inflammation. Voltarol Emulgel 1% w/w Gel: Contains propylene glycol and benzyl benzoate, which may cause skin irritation. Voltarol Emulgel Extra Strength 2% w/w Gel: Contains propylene glycol and butylhydroxytoluene which may cause skin reactions or irritations, and fragrance limonene and linalool which may cause allergic reactions. Side effects: Very rare: rash pustular, hypersensitivity (including urticaria), angioedema, asthma, photosensitivity reaction. Rare: Dermatitis bullous. Common: Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus. MA Holder: Haleon Ireland Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. MA Number: Voltarol 1% w/w Gel: PA 678/140/2. Voltarol 2% w/w Gel: PA 678/140/3. Legal Category: 1%: GSL, 2%: Pharmacy only. Text revised: July 2023. Further information available on request. Contains diclofenac diethylammonium. Always read the label/leaflet. Trade marks are owned by or licensed to the Haleon group of companies. PM-IE-VOLT-23-00025.

Diclofenac diethylammonium

diclofenac preparations over 6 to 12 weeks (60% diclofenac, 50% placebo, 4 studies, 2343 participants, NNT 9.8 (7.1 to 16)). In postherpetic neuralgia, topical high-concentration capsaicin had moderate equality evidence of limited efficacy (33% capsaicin, 24% placebo, 2 studies, 571 participants, NNT 11 (6.1 to 62)).

Summary

• There is good evidence that

some formulations of topical analgesics can provide reasonable outcome without AE’s associated with oral products. Regular application is important to optimise the benefits.

• Patient selection is an important factor. The ability of the individual to “apply” the agent is important and “patch” delivery systems can offer more reliable options.

NEWS - Digital Health Records

• Diclofenac and ketoprofen are useful in acute pain conditions such as sprains or strains, with low (good) NNT values. There is a strong message that the exact formulation used is critically important in acute conditions, and that might also apply to other pain conditions.

• In chronic musculoskeletal conditions with assessments over 6 to 12 weeks, topical

diclofenac and ketoprofen had limited efficacy in hand and knee osteoarthritis. Though NNTs were higher, this still indicates that a small proportion of people had good pain relief.

• Application of high-dose capsaicin in selective cohorts can have a significant impact although it might be 6-12 weeks before the full benefit can be seen. Topical lignocaine patches can be useful in some cases with benefits noticed usually after 5-10 days particularly in herpes zoster or persistent surgical incisional scar pain.

Author

Professor Dominic A. Hegarty. BSc., BMedSc., MB., MSc. (Pain Management), PhD. FCARSCI, FFPMCAI, FIPP

Consultant in Pain Management & Neuromodulation, Clinical Director Mater Private Hospital, Cork Associate Professor of Pain Medicine, UCC, Ireland

Honorary Consultant Guy’s & St. Thomas’ Hospital, London Clinical Lead Neuromodulation Research, Tyndall National Institute, UCC

President World Institute Of Pain (WIP)

Clinical Director Pain Relief Ireland www.painreliefireland.ie

Ref

Derry S, Wi en PJ, Kalso EA, Bell RF, Aldington D, Phillips T, Gaskell H, Moore RA. Topical analgesics for acute and chronic pain in adults - an overview of Cochrane Reviews. Cochrane Database of Systematic Reviews 2017, Issue 5. Art. No.: CD008609. DOI: 10.1002/14651858. CD008609.pub2.

Argoff C. Topical Analgesics in the Management of Acute and Chronic Pain Mayo Clin Proc. n February 2013;88(2):195-205 n http://dx.doi. org/10.1016/j.mayocp.2012.11.015

Minister for Health, Stephen Donnelly has published the Health Information Bill 2024, following approval by Government. The legislation, once enacted, will provide a legal basis for digital health records in Ireland, along with legal provisions on the sharing of patient data for care and treatment. It will also support Ireland’s obligations under the European Health Data Space (EHDS) Regulation, which will enter into force in autumn 2024.

The Health Information Bill is a vital component for the successful implementation of ‘Digital for Care: A Digital Health Framework for Ireland 2024 – 2030’ which was launched in June. The Bill empowers the Health Service Executive (HSE) to draw together health information from across care settings – public, private, and voluntary – for the development and deployment of digital health records for all patients.

Minister Donnelly said, “Integrated care as envisioned in Sláintecare, needs the right information, in the right place, at the right time. The Health Information Bill gives patients greater access to their own information so they can make informed decisions about their health and care options. It also enables health professionals to have a more complete, holistic view of the patients they are treating.”

Minister Donnelly added, “This legislation supports our national preparations for implementation of the EU Regulation on the EHDS which will come into force in autumn. This will transform how we access and use health information for care and treatment, as well as for important secondary-use purposes such as research and innovation.

“By harnessing digital, and unlocking the power of quality data, we are laying the foundations for an innovative, efficient, and truly modern health service.”

Migraine Care in Ireland

Over a billion people live with migraine worldwide, across all cultures, world regions and socioeconomic statuses, including over 700,000 in Ireland based on the current population. It is the 2nd leading cause of disability worldwide and accounts for more disability than any other neurological disorder, according to the Lancet Burden of Disease Study 2016.1 Migraine and other headache disorders are estimated by WHO to be the second leading cause of years lived with disability worldwide, the first for women under fifty years of age.2 A migraine attack is considered to be one of the most disabling experiences that a human being can have.3

It is believed that only a small percentage of individuals living with headache disorders ever come forward to receive care, making it largely a silent and invisible illness. Patients who live with headache disorders are recognised as being a heavily stigmatised and misunderstood group, perhaps the most stigmatised patient group of all (Shapiro

et at 2024,4 Migraine has historically been chronically under researched, underfunded, misunderstood, minimised and dismissed across broader society, within healthcare and within patients themselves through internalised stigma. Stigmatisation itself is recognised as a driver in the chronic underfunding and under researching of headache care. The experience of stigma has been shown to play a significant role in the exacerbation of chronic pain.5

Thankfully, there is something of a culture shift in migraine care. More research into and awareness of the condition and its manifestations alongside newly developed treatments are hopefully improving the quality of life of the many who live with the daily, often unnoticed challenges of the condition. This article hopes to explore how impactful changes can be made within the healthcare setting.

What is Migraine?

Migraine is understood now to be a disorder of nerve activity in the brain. When an attack is triggered, it causes a wide range of different symptoms and disabling experiences to the individual. Migraine

is classified into episodic and chronic migraine, depending on the number of days per month a person experiences migraine symptoms. Typically, a migraine attack lasts 4-72 hrs untreated and manifests with symptoms such as a one-sided pulsating headache of moderate to severe intensity, aggravated or causing avoidance of physical activity, nausea, vomiting, photophobia and phonophobia. (ICHD3, 6). It is a highly individualised condition however with an extremely broad range of other symptoms and manifestations, however. There are many subtypes with individual features. Some subtypes include migraine with aura, vestibular migraine, hemiplegic migraine, retinal migraine, menstrual migraine. It is helpful to be aware of other types of primary headache conditions, including New Daily Persistent Headache, Cluster Headache and TensionType Headache. These are conditions experienced by individuals with whom we regularly interact at Migraine Ireland. People who live with a headache disorder are at risk of developing complex complications such as secondary headache condition known as Medication Overuse Headache.

Written by Naomi Thornton, Migraine Association of Ireland

A LIFE IN MOTION

BEGINS WITH LESS MIGRAINE TM

Maintain a life in motion with only 4 injection days per year *1

• Flexible quarterly and monthly dosing1

• Rapid† and long-acting‡ efﬁcacy1,2

• Safety proﬁle comparable to placebo3,4

To ﬁnd out more, get in touch with an AJOVY® representative

AJOVY® is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month1

*Based on the quarterly dosing regimen1 †In Phase III pivotal studies, fewer migraine days were seen with AJOVY® vs placebo as early as Week 1 (p<0.0001)1 ‡Long-acting deﬁned as efﬁcacy over 12 months and is based on data for patients treated with AJOVY® in the HALO extension study (n=1,890)2

Please refer to the Summary of Product Characteristics (SmPC) for full details of Prescribing Information.

Ajovy® (fremanezumab) 225mg Solution for Injection in Pre-filled syringe and Ajovy® (fremanezumab) 225mg Solution for Injection in Pre-filled Pen Abbreviated Prescribing Information. Presentation: Fremanezumab 225mg solution for injection in pre-filled syringe. Fremanezumab 225mg solution for injection in pre-filled pen. Indications: For prophylaxis of migraine in adults who have at least 4 migraine days per month. Dosage and administration: The treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine. Ajovy is for subcutaneous injection only and can be injected into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. For multiple injections, injection sites should be alternated. Patients may self-inject if instructed in subcutaneous self-injection technique by a healthcare professional. Adults: Two dosing options are available: Monthly dosing: 225mg once monthly. Quarterly dosing: 675mg every three months. When switching dosing regimens, the first dose of the new regimen should be administered on the next scheduled dosing date of the prior regimen. The treatment benefit should be assessed within 3 months after initiation of treatment. Evaluation of the need to continue treatment is recommended regularly thereafter. Missed dose: The indicated dose

should resume as soon as possible, a double dose must not be administered to make up for a missed dose. Children: No data are available. Elderly: Limited data available. Based on the results of population pharmacokinetic analysis, no dose adjustment is required. Renal impairment: No dose adjustment is required. No data in severe renal impairment. Hepatic impairment: No dose adjustment is required. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions and warnings: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Anaphylactic reactions have been reported rarely with fremanezumab. Most reactions have occurred within 24 hours of administration although some reactions have been delayed. Patients should be warned about the symptoms associated with hypersensitivity reactions. If a serious hypersensitivity reaction occurs, initiate appropriate therapy and do not continue treatment with fremanezumab. No safety data are available in patients with certain major cardiovascular diseases. Interactions: No formal clinical drug interaction studies have been performed. Pregnancy and lactation: It is preferable to avoid the use of Ajovy during pregnancy as a precautionary measure. A risk to the breast-fed child cannot be excluded. A decision must be made whether to continue Ajovy therapy while breast-feeding. Effects on ability to

drive and use machines: No inﬂuence on the ability to drive and use machines. Adverse reactions: Anaphylactic reaction, hypersensitivity reactions such as rash, pruritus, urticaria and swelling. Very Common: Injection site pain, injection site induration and injection site erythema. Common: Injection site pruritus. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: It is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment if necessary. Legal category: POM. Marketing Authorisation Number: EU/1/19/1358/001004. Marketing Authorisation Holder: Teva GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany. Job Code: MED-IE-00076. Date of Preparation: November 2023.

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

References:

1. AJOVY® Summary of Product Characteristics. Teva Pharmaceuticals Ireland. 2. Goadsby PJ et al. Neurology 2020; 95(18): e2487–e2499. 3. Dodick DW et al. JAMA 2018; 319(19): 1999–2008. 4. Silberstein SD et al. N Engl J Med 2017; 377(22): 2113–2122.

Correct, informed management of headache conditions is essential to protect patients.

Migraine Burden

The burden of disability that comes with living with migraine is often not fully understood by society. Individuals can live with highly debilitating, pain, focal disturbances, nausea and vomiting, aphasia, dizziness, mobility issues and much more, depending on their diagnosis. Hemiplegic migraine for example can cause temporary paralysis of the face and limbs on one side of the body. In some cases, more commonly in the older populations, migraine symptoms can present without headache at all. Symptoms that are often overlooked yet carry significant quality of life issues include the pre and postdrome stages, where following an attack patients can be left for days with lingering symptoms such as exhaustion and brain fog. There is also what is known as inter-ictal burden of headache. This is the burden of living with the fear of the next attack. This burden can significantly impact a person’s quality of life, decision making and ability to live independently and interact with society.

Migraine is often described as an invisible or hidden disability. Many living with this condition live lives punctuated by stigma, misunderstanding and silent suffering. Much of this stems from societal legacy issues, for example, migraine has had an historic association as disease of women. This association has had a heavy hand in the chronic stigmatisation of the condition, and all that stems from this stigma. It is well documented that societal pressures on men have obstructed men from coming forward for help early in relation to their health concerns overall. This can put men at risk of developing more complex and severe manifestations of headache conditions before they come forward for help, which often require more complicated treatment and management.

Individuals living with migraine are at increased risk of social isolation and misunderstanding and discrimination in the workplace or at school or college. The largely invisible nature of the condition and its symptoms, coupled with fact that the term “migraine” is generally synonymous in daily society, with a bad headache attack, has caused many to manage the condition silently, alone and misunderstood, managing a silent burden that is even at times, unbeknownst to themselves. Individuals living with migraine are at risk of the socioeconomic dangers that come with disability. Building the awareness needed through education at all levels, healthcare practitioner - patient interactions, within healthcare itself and across broader public, societal and cultural spheres is paramount.

Migraine Care In Ireland

The patient who is concerned about headache symptoms, usually starts their journey by visiting their GP Practice or Emergency Department. Migraine can, and is often, managed at Primary Care level, often a specialist referral is needed too. Community pharmacists are crucial resources for migraine management in the community.

In recent years, migraine and headache care in Ireland has significantly improved. There are now several specialist headache clinics in the Dublin area, clinics in Cork and Galway, Limerick and more. There are a growing number of Consultant Neurologist Headache Specialists, Clinical Nurse Specialists and Psychologists providing specialist headache care within the hospital settings. Sometimes these clinics aren’t well known. Contacting your neurology department a finding out what resources are available within your clinical setting could prove a valuable resource to patients and to staff members.

Diagnosis can be lengthy, and usually involves a detailed history and patient diary keeping. Treatment depends on the history, diagnosis and circumstances of the patient, there are a range of acute and preventative treatments, including advanced treatments. Patient support with lifestyle management, understanding of their condition and how it manifests, and getting to understand “triggers” are all part of the process. Specialist physiotherapy, cognitive behavioural therapy, acupuncture are also recognised as supportive options for migraine care.

When Migraine Is Diagnosed

Often times a patient receives their diagnosis of migraine in hospital. Patients may have presented with what can be frightening symptoms. A series of investigations is carried to determine the cause and rule out life threatening conditions before the diagnoses is given. Understandably, there can be some initial relief experienced by both the patient themselves and their healthcare team, once more sinister or acutely threatening causes of their symptoms have been ruled out.

At Migraine Ireland, we frequently receive calls from patients who have been newly diagnosed with migraine after being hospitalised with their symptoms. Patients are often left reeling from a rollercoaster journey from hospital. Having for perhaps the first time experienced the scary and debilitating symptoms of migraine, the fear and trauma of having gone through the process of ruling out life threatening conditions, followed then perhaps by initial feelings of surprise and relief from receiving a diagnosis of migraine, only to be then faced with the gravity of being diagnosed with a complex, debilitating neurological condition, can be extremely confusing and hard to process the meaning of the experience and new diagnosis for many reasons.

Healthcare professionals are in an optimum position to significantly impact patient’s quality of life and outcome, and ability to cope. Providing education at this crucial stage can have a long-lasting positive effect. Resourcing patients in understanding, and preparing to manage their condition once discharged, empowers patients and makes a meaningful impact on a person’s ability to cope and quality of life, both of which have been shown to improve patient outcomes, and reduce the impact of symptoms.

Some examples of patient education could include, but are not limited to

- building an understanding of migraine as a condition within the patient

- explaining terms and developing understanding of terms such as episodic and chronic migraine

- the patient’s particular migraine condition and what this may mean for them, for example migraine without/with aura, hemiplegic migraine, vestibular migraine.

- Skill building, such as informed diary keeping, lifestyle and trigger knowledge in a sense that empowers the patient.

- Navigation and signposting for multidisciplinary follow up care

- Establishing the importance of GP and community pharmacy relationships

- Awareness of risks that the migraine community may face on their journey such as stigmatisation, social isolation, workplace challenges and supports that are available, such as Migraine Ireland, Disability Federation of Ireland, HSE Living Well Course, Social Prescribing.

Hopes For the Future

With greater awareness, understanding and knowledge, there is hope that the quality of life and disease burden of individuals living with migraine can be improved. Thankfully, in many cases, the condition is treatable when managed effectively. Healthcare professionals, both in the hospital setting and elsewhere are placed within a unique opportunity to make long lasting meaningful impacts into the lives of many who are often overlooked. We at Migraine Ireland wish to thank you profoundly for your interest in this patient cohort and remain at your disposal for any support whatsoever that we can provide.

References

1. Global Burden of Disease Study 2016 (GBD 2016) Data Resources | GHDx (healthdata. org)

2. Vos T, Allen C, Arora M. Global regional and national incidence prevalence and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1545–602.

3. Silver, Nick (2018) Migraine - a comprehensive guide (thewaltoncentre.nhs. uk)

4. Shapiro et al 2024 Migraine-Related Stigma and Its Relationship to Disability, Interictal Burden, and Quality of Life | Neurology

5. Parikh et al Stigma and Migraine: Developing Effective Interventions | Current Pain and Headache Reports (springer.com)

6. 1. Migraine - ICHD-3

7. Hämel et al How do nurses support chronically ill clients’ participation and self-management in primary care? A crosscountry qualitative study | BMC Primary Care | Full Text (biomedcentral.com)

8. Benkel et al Living with a chronic disease: A quantitative study of the views of patients with a chronic disease on the change in their life situation - Inger Benkel, Maria Arnby, Ulla Molander, 2020 (sagepub.com)

of liquid pain relief

Rapidly Absorbed

Targets Pain Fast*

*Ibuprofen soft capsules vs normal release tablets

Easofen Rapid Relief Max Strength 400 mg soft capsules. Each soft capsule contains 400 mg of ibuprofen. Presentation: Oval shaped, soft gelatin capsule containing clear colourless liquid. Indications: In adults and adolescents weighing from 40 kg (12 years and above) for the short-term symptomatic treatment of mild to moderate pain such as headache, period pain, dental pain and fever and pain associated with the common cold. Dosage: Adults and adolescents weighing from 40 kg (12 years and above): Initial dose is one capsule (400 mg). Then, if necessary, additional dose of 400 mg can be taken with the interval of six hours between doses. A total dose of 1,200 mg ibuprofen (three capsules) should not be exceeded in any 24-hour period. Refer to Summary of Product Characteristics for full prescribing information. Method of administration: Oral use. The capsules should be taken with a glass of water. Contraindications: Hypersensitivity to the active substance or any of the excipients. History of hypersensitivity reactions. History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/haemorrhage. Severe hepatic, renal or heart failure. Patients with cerebrovascular or other active bleeding. Patients with unclarified blood-formation disturbances. Severe dehydration. During the last trimester of pregnancy. Warnings and precautions: Caution is required in patients with certain conditions, which may be made worse: systemic lupus erythematosus and mixed connective tissue disease, congenital disorder of porphyrin metabolism, gastrointestinal disorders and chronic inflammatory intestinal disease, hypertension and/or cardiac impairment, renal impairment, hepatic dysfunction, directly after major surgery, in patients who show allergic reactions to other substances, hayfever, nasal polyps, chronic obstructive respiratory disorders or history of allergic disease. The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases risk of adverse reactions and should be avoided. The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding (GI) and perforation which may be fatal. Serious skin reactions, some of them fatal, have been reported very rarely in association with NSAIDs. Caution is required prior to starting treatment in patients with a history of hypertension and/or heart failure. Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely. At the first signs of a hypersensitivity reaction therapy must be stopped. Ibuprofen may temporarily inhibit the blood-platelet function. It is recommended to monitor patients with coagulation disturbances. In prolonged administration of ibuprofen, regular checking of the liver values, kidney function and blood count is required. Through concomitant consumption of alcohol, undesirable effects may be increased on use of NSAIDs. Ibuprofen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. Contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product. Interactions: Concomitant administration of ibuprofen and acetylsalicylic acid, other NSAIDs, digoxin, phenytoin, lithium, corticosteroids, anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs), anticoagulants, probenecid, sulfinpyrazone, diuretics and other antihypertensive drugs, methotrexate, cyclosporine, tacrolimus, zidovudine, sulphonylureas, quinolone antibiotics, mifepristone and CYP2C9 inhibitors. Fertility, pregnancy and lactation: Ibuprofen should not be given during the first and second trimester of pregnancy unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first and second trimester, the dose should be kept as low and duration of treatment as short as possible. Ibuprofen is contraindicated during the third trimester. Ibuprofen appears in the breast milk in very low concentration and unlikely to affect the breast-fed infant adversely. There is some evidence that drugs which inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility. This is reversible on withdrawal of treatment. Driving and operation of machinery: Ibuprofen generally has no or negligible influence on the ability to drive and use machines. Undesirable effects: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been observed. Particularly the risk of gastrointestinal bleeding occurring is dependent on the dose range and the duration of use. Refer to the SmPC for other undesirable effects. A copy of the SmPC is available on request. Pack size: 20 capsules.

Pharmacy Research

School of Pharmacy Antipsychotic-Induced Weight Gain Research

First-of-its-kind study from St Patrick’s Mental Health Services and University College Cork explores preferences and needs of those with lived experiences of weight gain from anti-psychotics.

Professor Laura Sahm, Head of Clinical Pharmacy Practice at UCC and Senior Pharmacist at St Patrick’s Mental Health Services, Ita Fitzgerald

The study, Informing the development of antipsychoticinduced weight gain management guidance: patient experiences and preferences - a qualitative descriptive study, which was published in BJPsych Open on 1 August 2024, explores how patients with lived experiences of antipsychotic-induced weight gain (AIWG) perceive and manage this challenging side-effect.

Clinically significant weight gain has been linked to almost all antipsychotic medications, prescribing of which extends to many mental health difficulties beyond psychosis, and is usually seen within weeks of starting treatment.

Managing weight gain effectively in patients with mental health difficulties who are taking

antipsychotics is crucial to ensuring their physical health is maintained. However, while limited international guidance exists, management recommendations for clinicians largely replicates recommendations for population level weight management practices, with self-led ‘lifestyle changes’ given prominence, and the use of additional medications to reduce antipsychotic-induced appetite increases considered only when other options have proven ineffective.

The development of available management recommendations has largely been informed by the expert opinion of guideline development groups, with no or minimal representation of the voice of lived experience. This study was the first of its kind to explore the management preferences of patients with experience in managing weight gain from antipsychotics and to compare this with current management algorithms informing clinicians’ practice.

A diverse range of people (n = 17) with experiences of mild to severe antipsychotic-induced weight gain and mental health difficulties including schizophrenia, bipolar affective disorder and

major depressive disorder were interviewed regarding:

• Their experiences of managing AIWG

• The acceptability, feasibility, and transferability of current management algorithms and the interventions contained within (both pharmacological and non-pharmacological)

• How patient-centred management practices can be realised within Irish healthcare settings.

Speaking about the study, Lead Researcher and Senior Pharmacist at St Patrick’s Mental Health Services, Ita Fitzgerald said: “Findings have shown that the lack of available management guidance for antipsychotic-induced weight gain remains a challenge for clinicians, with currently endorsed approaches neither being fitfor-purpose or aligned with the experiences and needs of those prescribed antipsychotics and who experience unwanted weight gain.

This study provides guidance and recommendations for ways in which a proactive, individualised, holistic, and collaborative approach to AIWG management can be practically realised both within guidelines and services. It is hoped that the publication of this study will mark a significant step towards empowering and supporting clinicians to manage the complex side effect of antipsychotic-induced weight gain in a way that is most responsive to the needs of the individual patient.”

Key Findings

1. Patient preferences for management differ significantly from that advocated for in management guidelines: Patients with AIWG describe current management guidelines as overly simplistic and lacking the flexibility required for management to be tailored towards their needs. The standardised, stepwise approach, universally recommended and focusing primarily on the use of lifestyle changes, does not reflect the realities of managing overweight or obesity caused by antipsychotics.

2. Behavioural changes are often insufficient: Many participants

reported that lifestyle changes alone were insufficient to manage AIWG. Continued recommendations from clinicians to implement lifestyle changes could worsen feelings of isolation and internalised stigma, while also reducing the likelihood of seeking help in future due to fear of stigma.

3. Individualised approaches are key: Participants emphasised that AIWG is a unique cause of weight gain and as such, requires an equally distinctive approach to management. Recommendations for management of AIWG must recognise diversity among individuals and allow for interventions to be tailored towards risk of living with overweight or obesity, individual physical and mental health capabilities and patients’ treatment preferences.

4. Need for early use of pharmacological interventions: Study participants advocated for the earlier use of pharmacological interventions, such as metformin, especially for those who are severely ill at the onset of antipsychotic treatment, have a personal or family history of living with obesity, or where appetite increases following starting an antipsychotic are severe.

Professor Laura Sahm, co-author of the study and Head of Clinical Pharmacy Practice at UCC, said: “This study represents a crucial step in recognising the importance of a patient-centred and patientinformed approach to combat antipsychotic-induced weight gain. By working collaboratively, patients and prescribers can adopt a strategy that aligns best with their shared and agreed goals of therapy.”

Based on the experiences of participants, the study recommends that current guidelines are expanded to include preventive measures and early interventions tailored to individual patient needs and risks. The study recommendations also put forward ways in which the four tenets of patient-centred management (proactive, individualised, holistic and collaborative approaches) can be enacted both within guidelines and psychiatric services.

A LIFE IN MOTION

BEGINS WITH LESS MIGRAINE TM

Maintain a life in motion with only 4 injection days per year *1

• Flexible quarterly and monthly dosing1

• Rapid† and long-acting‡ efﬁcacy1,2

• Safety proﬁle comparable to placebo3,4

To ﬁnd out more, get in touch with an AJOVY® representative

AJOVY® is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month1

Please refer to the Summary of Product Characteristics (SmPC) for full details of Prescribing Information.

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

References:

Ground-Breaking App for Menopause

Women will soon have the power to overcome devastating menopause symptoms in the palm of their hand, thanks to a ground-breaking Irish digital health app.

The Menopause Hub App, the first of its kind in this country, includes the latest information and research about the hormonal changes women in their 40s and 50s experience.

Women can also use the mobile app to monitor their own menopausal and perimenopausal symptoms, and receive medication reminders.

Launched by award-winning treatment specialists, The Menopause Hub, the app is the brainchild of the clinic’s CEO and founder, Loretta Dignam.

She opened her first clinic in 2019 after finding out for herself the lack of help available to menopausal and perimenopausal women – and said the data gathered by the app can be used by researchers investigating future treatments.

“The aim is that the data gathered by the app will provide a valuable insight into the effectiveness of current therapies, such as HRT and/or cognitive behavioural therapies, and this knowledge can also be used by clinicians when prescribing treatments.

“Combining the latest technology with up-to-date data about female health will not only improve outcomes for women today, but will also improve the range and

impact of menopause treatments available to future generations,” said Ms Dignam.

“There is a myriad of menopausal symptoms which women in their 40s and 50s experience in varying degrees, including insomnia, hot flushes, anxiety, depression, and brain fog, to name but a few.

“Every women’s menopause will be vastly different.

“Some will sail through it, while others will struggle to such an extent that they feel they have to give up their careers or their longterm relationships break down.

“It is, therefore, vital that we gather as much clinical data as we can to help medical researchers develop future treatments.

“For far too long, the impact menopause was having on women’s lives was ignored.

“But women are now demanding –and deserve – more help with symptoms.”

The app was developed by medical technology company, Zendra Health, who are helping over 80 healthcare services and organisations across the US, UK and Ireland digitalise their care pathways.

Zendra CEO, Thomas Coleman, said that the App was co-

Menopause Society Conference

Join the Menopause Society of Ireland for its inaugural annual conference on 14 September 2024 at the Mansion House in Dublin. This event marks a significant step forward in the society’s mission to advance menopause care in Ireland.

By fostering collaboration between local and international experts, the conference will enhance knowledge, exchange best practices, and improve outcomes for women experiencing menopause. Through insightful presentations, interactive discussions, and networking opportunities, attendees will gain valuable insights and forge connections to drive progress in menopausal health.

For further information about the Irish Menopause Society or to find out more about the conference, visit the society’s website at www.menopausesociety.ie

The event will be held on Saturday 14th September and will held all day at The Mansion House, Dublin 2.

“Hundreds of thousands of lives across Ireland, male and female, are impacted by menopause,” said Mr Coleman, who co-founded the Dún Laoghaire-based tech firm with his twin brother, David.

“So we were delighted to develop this streamlined digital care solution for The Menopause Hub.

“Loretta is one of the thought leaders in this area and we were guided not only by her expertise but by the expertise of her medical team and by the experiences of their clients.”

The Menopause Hub App will be available to download FREE in September from the Google Play Store and the App Store Visit themenopausehub.ie for more details.

TREAT the HEAT WITH

NON-HORMONAL VEOZA

VEOZA (fezolinetant) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 1

VMS are also known as hot flushes and night sweats. 2

First-in-class selective neurokinin 3 (NK3) receptor antagonist to be licensed 1,3

Statistically significant reductions in VMS frequency & severity at Weeks 4 & 12 vs. placebo.1

Evaluated for safety over 52 weeks1

Once-daily oral dosing with VEOZA 45 mg 1

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Concomitant use of moderate or strong CYP1A2 inhibitors. Known or suspected pregnancy. 1 The most frequent adverse reactions with Veoza were diarrhoea (3.2%) and insomnia (3.0%). 1

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

NK3: neurokinin 3, VMS: vasomotor symptoms.

References: 1. VEOZA Summary of Product Characteristics. 2. Thurston RC. Vasomotor symptoms. In: Crandall CJ, et al. eds. Menopause Practice: A Clinician’s Guide. 6th ed. Pepper Pike, OH: The North American Menopause Society. 2019:43–55. 3. Depypere H, et al. Expert Opin Investig Drugs. 2021;30(7):681–694.

Prescribing Information

VEOZA™▼ (fezolinetant) 45 mg film-coated tablets

Name: VEOZA 45 mg film-coated tablets. Presentation: Film-coated tablets containing 45 mg fezolinetant. Indications: Treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Posology and Administration: The recommended dose is 45 mg orally once daily at about the same time each day with or without food. Tablets are to be taken with liquids, swallowed whole and not broken, crushed, or chewed. Benefit of long-term treatment should be periodically assessed since the duration of VMS can vary by individual. Missed dose: Take as soon as possible, unless there is < 12 hours before the next scheduled dose. Return to regular schedule the following day. Elderly: Safety and efficacy has not been evaluated in women initiating VEOZA over 65 years of age. No dose recommendation. Hepatic impairment: Mild hepatic impairment: No dose modification. Moderate/severe hepatic impairment: Not recommended (See summary of product characteristics [SPC] section 4.2 & 5.2). Renal impairment: Mild/moderate renal impairment: No dose modification. Severe renal impairment/ end-stage renal disease: not recommended (See SPC section 4.2 & 5.2). Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SPC; Concomitant use of moderate or strong CYP1A2 inhibitors (see SPC section 4.5); Known or suspected pregnancy (see SPC section 4.6). Warnings and precautions: Medical examination/ consultation Prior to the initiation or reinstitution of VEOZA, a careful diagnosis should be made, and complete medical history (including family history) must be taken. During treatment, periodic check-ups must be carried out according to standard clinical practice. Liver disease Veoza is not recommended for use in individuals with Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment. Women with active liver disease or Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment have not been included in the clinical efficacy and safety studies with fezolinetant (see SPC section 4.2) and this information cannot be reliably extrapolated. The pharmacokinetics of fezolinetant has been studied in women with Child-Pugh Class A (mild) and B (moderate) chronic hepatic impairment (see SPC section 5.2). Monitoring of liver function in women with known or suspected hepatic disorder is advised during treatment. ALT and AST elevations Elevations in serum alanine aminotransferase (ALT) levels at least 3 times the upper limit of normal (ULN) occurred in 2.1% of women receiving fezolinetant compared to 0.8% of women receiving placebo. Elevations in serum aspartate aminotransferase (AST) levels at least 3 times the ULN occurred in 1.0% of women receiving fezolinetant compared to 0.4% of women receiving placebo (see SPC section 4.8). ALT and/or AST elevations were not accompanied by an increase in bilirubin (greater than two times

the ULN, i.e., there were no cases of Hy’s law) with fezolinetant. Women with ALT or AST elevations were generally asymptomatic. Transaminase levels returned to pre-treatment levels (or close to these) without sequelae with dose continuation, and upon dose interruption, or discontinuation. Acute liver test abnormalities may necessitate the discontinuation of Veoza use until the liver tests return to normal. Known or previous breast cancer or oestrogen-dependent malignancies Women undergoing oncologic treatment (e.g., chemotherapy, radiation therapy, anti-hormone therapy) for breast cancer or other oestrogen-dependent malignancies have not been included in the clinical studies. Therefore, VEOZA is not recommended for use in this population as the safety and efficacy are unknown. Women with previous breast cancer or other oestrogen-dependent malignancies and no longer on any oncologic treatment have not been included in the clinical studies. A decision to treat these women with Veoza should be based on a benefit-risk consideration for the individual. Concomitant use of hormone replacement therapy with oestrogens (local vaginal preparations excluded) Concomitant use of fezolinetant and hormone replacement therapy with oestrogens has not been studied, and therefore concomitant use is not recommended. Seizures or other convulsive disorders Fezolinetant has not been studied in women with a history of seizures or other convulsive disorders. There were no cases of seizures or convulsive disorders during clinical studies. A decision to treat these women with VEOZA should be based on a benefit-risk consideration for the individual. Interactions: Effect of other medicinal products on fezolinetant: CYP1A2 inhibitors Fezolinetant is primarily metabolised by CYP1A2 and to a lesser extent by CYP2C9 and CYP2C19. Concomitant use of moderate or strong CYP1A2 inhibitors (e.g., ethinyl oestradiol containing contraceptives, mexiletine, enoxacin, fluvoxamine) with VEOZA is contraindicated (see SPC section 4.). See SPC section 4.5 for full list of interactions. Fertility, pregnancy and lactation: Pregnancy VEOZA is contraindicated during pregnancy. If pregnancy occurs during use with VEOZA, withdraw treatment immediately. Perimenopausal women of childbearing potential should use effective contraception; non-hormonal contraceptives are recommended. Breast-feeding VEOZA is not indicated during lactation. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or discontinue/abstain from VEOZA therapy. Fertility No data is available on the effect of fezolinetant on human fertility. Undesirable effects: Summary of the safety profile: The most frequent adverse reactions with fezolinetant 45 mg were diarrhoea (3.2%) and insomnia (3.0%). There were no serious adverse reactions reported at an incidence greater than 1% across the total study population. On fezolinetant 45 mg, four serious adverse reactions were reported. The most serious adverse reaction was an event of endometrial

adenocarcinoma (0.1%). The most frequent adverse reactions leading to dose discontinuation with fezolinetant 45 mg were alanine aminotransferase (ALT) increased (0.3%) and insomnia (0.2%). List of adverse reactions: The safety of fezolinetant has been studied in 2203 women with VMS associated with menopause receiving fezolinetant once daily in phase 3 clinical studies. Adverse reactions observed during clinical studies are listed below by frequency category and MedRA system organ class. Frequency categories are defined as follows: common (≥ 1/100 to < 1/10). Psychiatric disorders: Common: Insomnia. Gastrointestinal disorders: Common: Diarrhoea, abdominal pain. Investigations: Common: Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased. Prescribers should consult the full summary of product characteristics in relation to other adverse reactions. Effect on ability to drive and use machines: VEOZA has no/negligible effect on ability to drive or use machines. Overdose: Doses of fezolinetant up to 900 mg have been tested in clinical studies in healthy women. At 900 mg, headache, nausea, and paraesthesia were observed. In case of overdose, closely monitor the individual. Consider supportive treatment based on signs and symptoms. Package Quantities, Basic cost: VEOZA (30 pack tablets): POA. Legal Classification: POM/S1A. Product licence number: EU/1/23/1771/001. Marketing Authorisation Holder: Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, The Netherlands. Date of Preparation of Prescribing Information: December 2023. Document number: MAT-IE-VEO-2023-00001. Further information available from: Astellas Pharma Co. Ltd., Tel.: +353 1 467 1555. For full prescribing information, please see the SPC which may be found at: www.medicines.ie

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

The hyperlinks on this page will take you to non-Astellas websites. Astellas does not endorse or accept liability for sites controlled by third-parties.

MAT-IE-VEO-2024-00022. June 2024.

F i n d Y o u r N a t u r a l B a l a n c e

Continuing Professional Development

CPD: Emergency Contraception

AUTHOR: Donna Cosgrove, MPSI, PhD

Donna did her Pharmacy degree in RCSI, and then returned to university to pursue an interest in psychiatric conditions and treatments through a MSc in Neuropharmacology. This led to a PhD investigating the genetics of schizophrenia using data from genome-wide association studies and cognitive test data. This was followed by a postdoctoral research position in a similar area. Donna has worked in hospital, research and community pharmacy settings, and currently works as a community pharmacist in Galway, and as a clinical writer. Donna’s overall aim is to improve patient outcomes through education.

60 Second Summary

Incorrect use of contraceptives or contraceptive failure such as condom breakage, missed pills, incorrect timing of patch or vaginal ring application, contraceptive non-use, forced intercourse, and other circumstances, place women at risk of unintended pregnancy. There is a critical role for emergency contraception (EC) in preventing those pregnancies. Pharmacists are equipped with the skills and knowledge about EC to advise women, and where necessary, to address potential barriers to emergency contraceptive use. It is important for pharmacists to have an awareness of these barriers described by women seeking EC, and that evidence based information is used to address specific individual needs to ensure appropriate advice about EC use.

Pregnancy is theoretically possible after UPSI on most days of the cycle, but is highest during the 6 days leading up to and including the day of ovulation. It can be difficult to accurately estimate the timing of ovulation using the usual cycle length and date of the last menstrual period.

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

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

3. PLAN - If I have identified a

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

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

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

4 previous steps, log and record your findings.

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

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

The Research Behind Emergency Contraception

Introduction

A national report from Ireland found that 16% of all pregnancies experienced by women in 2010 were defined as a crisis (unplanned) pregnancies.1

Incorrect use of contraceptives or contraceptive failure such as condom breakage, missed pills, incorrect timing of patch or vaginal ring application, contraceptive non-use, forced intercourse, and

other circumstances, place women at risk of unintended pregnancy. There is a critical role for emergency contraception (EC) in preventing those pregnancies. EC is indicated for women who do not want to conceive after unprotected sexual intercourse (UPSI) on any day of a natural menstrual cycle, or if their regular contraception use has been compromised. It is intended for occasional use, i.e. not to replace effective contraception.2

877 out of the 1,213 survey respondents had unprotected sex in the past year, for various reasons (Figure 1). This figure came from research conducted by Empathy Research on behalf of ellaOne®,3 collected through an online survey (n=1,213 females, aged 18-34 years) in May 2023.

Incidence & Frequency of Having Unprotected Sex

Figure 1. Incidence and Frequency of Having Unprotected Sex3

The way that EC effectiveness is explained to women is important, e.g. if 1% of all women receiving a particular method of EC within 72 hours of UPSI at any time in the cycle become pregnant, the overall pregnancy rate is quoted as 1%. However, for a large proportion of women included, UPSI would not have occurred during the fertile period, and pregnancy would not have occurred in any case.

In terms of drug interactions and EC, enzyme inducing drugs can reduce the effectiveness of oral EC. In some cases, a double dose (3mg) of LNG-ED may be considered, however, the efficacy of this has not been fully established.

Have you ever had unprotected sex (with vaginal penetration), where the contraception failed or where no contraception was used (when not trying to get pregnant)

Results from the survey3 indicated that advice from health care professionals about EC is important in influencing decisions about EC use (Figure 2), although Google is the most likely source of information on sex and sexual health.

Role of the Pharmacist

Pharmacists are equipped with the skills and knowledge about EC to advise women, and where necessary, to address potential barriers to emergency contraceptive use. It is important for pharmacists to have an awareness of these barriers described by women seeking EC, and that evidence based information is used to address specific individual needs to ensure appropriate advice about EC use. Some women may be uncomfortable discussing sensitive sexual health topics or hesitant to ask for more information on EC. It is essential that anyone seeking information in a pharmacy setting feels a level of trust and comfort in order to enable discussion about the safe and effective use of EC.

(Base: All females aged 18-34 that had sex before n=1,201)

42 CPD: Emergency Contraception

Where information is sought in relation to sex and sexual health

(Base: All females aged 18-34 n=1,213)

Figure 2. Where information is sought in relation to sex and sexual health3

(Base: All females aged 18-34 n=1,213)

customers of pharmacies often need encouragement to ask questions, especially those who do not have knowledge of a product, or for sensitive or uncomfortable topics. Almost a third of women surveyed stated embarrassment about asking for EC in pharmacy as a reason for not taking it (Figure 3), showing just how common an issue this is. When this engagement between a woman and a member of pharmacy staff takes place, empathy and a non-judgemental tone is a key step to a successful consultation: this consultation can then open a discussion further to the broader area of sexual health and awareness. The PSI recommends use of the consultation room for these conversations due to the nature of these medicines and the counselling requirements.4

Where do you seek information on sex and sexual health?

Google

Health Professionals – doctors, nurses, pharmacists

Friends

Sexual Health Clinic

TikTok

Instagram

Parents

Other family members

Google (74%) is cited as the most likely source of information on sex and sexual health, with health professionals next most likely to be cited.

Although 67% of respondents to this online survey (aged 18-24) had availed of the free contraception scheme in Ireland, nearly 20% of women were still not even aware of the government’s free contraception scheme (Figure 4).

opted for oral options, either the combined oral contraceptive (COC) or progestogen only pill (POP). 25% have used EC (Figure 5).

Emergency Contraception

Pregnancy is theoretically possible after UPSI on most days of the cycle, but is highest during the 6

Figure 3. Reasons for not taking EC when potentially needed3

(Base: All females aged 18-34 that had unprotected sex and didn't take the morning after pill when it may have been needed in the past year n=360)

difficult to accurately estimate the timing of ovulation using the usual cycle length and date of the last menstrual period. There is evidence to show that ovulation estimation in this way is imprecise when correlated with serum and ultrasound markers of ovulation. The resulting advice is to offer EC after UPSI on any day of the cycle, although choice of EC may be influenced by timing. The Faculty of Sexual and Reproductive Healthcare EC guidelines3 includes a decision-making algorithm that may help with choice of EC.

begins at implantation, therefore, any intervention given for EC must prevent fertilisation or implantation, and not disturb established implantation.2 The shortest time from ovulation to implantation is 6 days (although more usually 8-10 days).

Mechanism of Action of Emergency Contraception

Reasons For Not Taking The Morning After Pill When Potentially Needed

(Base: All females aged 18-34 that had unprotected sex and didn’t take the morning after pill when it may have been needed in th e past year n=360)

2023

I didn't think I was near ovulation/ in my fertile window

I decided to risk it and hope that it didn't result in an unplanned pregnancy

I thought I was just overreacting

I’ve had unprotected sex before and it has never resulted in an unplanned pregnancy so thought it would be ok

I was too embarrassed to go into a pharmacy to get it

I researched online and decided that I probably didn't need to take it

I couldn’t afford it

I was worried about the side effects

I was concerned it could affect my future fertility

A friend convinced me that I didn’t need to take it

What were the reasons for not taking the morning after pill when it may have been needed on other occasions?

The copper intrauterine device (Cu-IUD) has multiple mechanisms of action:2 one is through its adverse effects on the motility

Increases in the proportion of those who did not take the morning after pill because they could not afford to do so or becaus they were too embarrassed to do so.

Figure 4. Proportion of women who have availed of

and viability of the sperm, and the viability and transport of the egg. In addition, the local endometrial inflammatory reaction which results from the presence of the Cu-IUD prevents implantation, meaning that it is effective pre and post fertilisation.

Ulipristal acetate (UPA) is a selective progesterone receptor modulator which delays ovulation for at least 5 days, i.e. until sperm from the UPSI are no longer viable. Ulipristal acetate emergency contraception (UPA-EC) delays ovulation even after the luteinising hormone (LH) surge, whereas LNG-EC does not. However, UPA-EC cannot inhibit ovulation at or after the LH peak. With UPA-EC, no significant reduction in effectiveness is observed with increasing time between UPSI and administration (up to 120 hours).

Levonorgestrel (LNG) inhibits ovulation, delaying follicular rupture and causing luteal dysfunction. If taken before the LH surge, ovulation is delayed for 3 days.

Neither oral EC impaired endometrial receptivity (in vitro), or embryo attachment. Women who take oral EC should be made aware that they are likely to go on to ovulate later in the cycle.

Effectiveness of Emergency Contraception

Incidence of Having Availed the Government’s Free Contraception Scheme

(Base: All females aged 18-34 n=1,213)

Have you availed of the government’s free

Almost a third (31%) claim to have availed of the government’s free contraception scheme, with`18 done so.

Almost a third (31%) claim to have availed of the government’s free contraception scheme, with`18-24’s more likely to have done so.

If an individual woman requests the method of EC after UPSI that has taken place just before her likely time of ovulation, it would be inappropriate to tell her that if she uses the method she has only a 1% chance of pregnancy. The overall pregnancy rate after administration of UPA-EC is about 1-2%: this is out of all women who take UPA-EC, not specifically women who have taken UPAEC just prior to ovulation. The estimated percentage of pregnancies likely to be prevented by UPA-EC is 60-80%.

A meta-analysis5 has suggested that UPA-EC is significantly more

effective than LNG-EC when taken from 0-120 hours post UPSI. The analysis included 1696 women who received emergency contraception within 72 h of sexual intercourse (UPA, n=844; LNG, n=852). There were 15 pregnancies in the UPA group (1.8%) and 22 in the LNG group (2.6%). In 203 women who received emergency contraception between 72 h and 120 h after sexual intercourse, there were three pregnancies, all of which were in the LNG group. In general, studies have reported the overall pregnancy rate in women taking LNG-EC at any time in the cycle as 0.6-2.6%.

In terms of which type of EC is the most effective, the Cu-IUD is the most effective method of EC. A Cu-IUD can be inserted up to 5 days after the first UPSI in a natural menstrual cycle, or up to 5 days after the earliest likely date of ovulation (whichever is later). Cu-IUD is the only method of EC that is effective after ovulation has taken place (but is inserted well before the earliest likely date of implantation to ensure it does not disrupt an already implanted pregnancy). It is not affected by BMI or other drugs.2

Methods of Contraception Availed from the Government’s Free Contraception

(Base: Those that vailed the Government’s Free Contraception Scheme n=376)

Figure 5. Rates of use of

(Base: Those that availed the Government's Free Contraception Scheme n=376)

UPA-EC is effective for up to 120 hours post UPSI, and LNG-EC up

Which form of contraception have you availed of?

Total

The pill (combined pill or mini pill)

The morning after pill

The Coil (IUD or IUS)

An implant/ ‘The bar’

Contraceptive patch

Injectable contraception

Vaginal ring

Other

7 in 10 (70%) of those who have availed of the free contraception from the government have availed of the pill.

CPD: Emergency Contraception

to 72 hours. UPA-EC, however, has demonstrated greater efficacy. UPA-EC should be considered as the first-line oral EC for a woman who has had UPSI 96–120 hours ago, and as the first-line oral EC for a woman who has had UPSI within the last 5 days if the UPSI is likely to have taken place during the 5 days prior to the estimated day of ovulation.

The percentage of pregnancies prevented was significantly higher in subjects who were pre-ovulatory (77.6%) compared with those who were post-ovulatory (36.4%) at the time of UPA administration.6 It was observed that pre-ovulatory administration resulted in a delay of the next menstruation by a median of 3 days, whereas postovulatory administration resulted in a minimal advancement of the next menstruation by a median of 1 day.

Factors to Consider when Providing Emergency Contraception

 Providers of EC who don’t offer the complete range of EC methods should offer information about the other methods and advise where these may be available, e.g. Cu-IUD. Oral EC should still be given in case the Cu-IUD cannot be inserted for whatever reason.2

 Available evidence suggests that both oral ECs have their effect by delaying ovulation, therefore if taken after ovulation it is not effective: women seeking EC should be given this information.

 The Cu-IUD provides both EC and effective ongoing contraception, unlike oral methods.

 If pregnancy risk from UPSI is low, it may be important to prioritise the immediate quick start of hormonal contraception in order to reduce pregnancy risk from further UPSI. LNG-EC may be preferred over UPA-EC in this case. LNG-EC is also preferred in cases of recent progestogen use, i.e. if a woman requires EC due to missed pills, because theoretically the effectiveness of UPA-EC may be reduced with circulating progestogen.

 After taking LNG-EC, women can start appropriate hormonal contraception immediately, whereas with UPA-EC, they must wait for 5 days. Reliable condom use or abstinence is necessary until contraception becomes effective.

 If a woman has a BMI >26 kg/m2 or weight >70 kg, the efficacy of LNG-EC may be reduced, but not UPA-EC. A double dose of LNG-EC can be given, or else UPA-EC. It has not been established which is more effective.

 BMI can affect (reduce) the effectiveness of oral EC, but does not affect Cu-IUD.

 It’s important to make women aware that oral EC does not prevent pregnancy for subsequent UPSI, and that they need to take the usual contraceptive precautions.

 UPA-EC is not suitable for women who have severe asthma requiring oral glucocorticoid treatment.

 For breastfeeding women, (limited) evidence indicates that LNG-EC has no adverse effects on breastfeeding or infants. Those who take UPA-EC should be advised not to breastfeed for a week after administration.

 Oral EC can still be used if there was UPSI earlier in the menstrual cycle: evidence suggests that neither type of EC disrupts an existing pregnancy. Both ECs can also be used more than once in a single cycle. However, if UPA-EC has already been taken, LNG-EC should not be taken within the following 5 days. If LNG-EC has already been taken, UPA-EC could theoretically be less effective if taken in the following 7 days.

 Repeated administration of UPA-EC is well tolerated and can continue to delay ovulation for some time. However, ovulation does eventually occur after UPAEC in the majority of women.

 Information about methods of ongoing contraception, and how to get these, should also be offered to women requesting EC.

 If a woman is less than 16 years old, it is usual that parental consent is sought: the age of sexual consent in Ireland is 17 years.4

Drug Interactions

be advised to use a Cu-IUD, which is not affected by liver enzyme inducers. If this is not an option, the doubling of the usual dose of LNG-EC is recommended to compensate for the reduction in blood LNG-EC levels. No increased risk of side effects is expected with a double dose of LNG-EC.4

Another particular interaction of note, as mentioned previously, is that the contraceptive effect of UPA-EC may be reduced if a progestogen is taken in the 5 days after taking UPA-EC, i.e. if a woman continues taking certain types of oral contraception containing progestogens like cyproterone, drospirenone and estradiol, among others.7 Ulipristal prescribing information cautions that concurrent use of progestogen-containing products should be avoided and that patients should wait at least 5 days after stopping ulipristal before resuming or starting any hormonal contraceptive. The effect of UPA-EC on delaying ovulation

by 5 days is significantly reduced by the use of a desogestrel POP started immediately after UPA-EC administration. The effect of other progestogen-containing drugs has not been officially studied, but it is still recommended that all products containing progestogen/ progesterone be avoided for 5 days post UPA-EC administration (i.e. contraception and HRT). Similarly, although the effect of progestogen when taken before UPA-EC has not been formally studied, as a general rule, if a woman has taken any progestogen in the week prior to EC, UPA-EC efficacy may be reduced and as a result LNG-EC is preferred.

In a prospective, randomised study, administration of UPA-EC followed by desogestrel (0.75 mg daily) initiated the next day resulted in ovulation occurring in 13 of 29 (45%) cycles compared to ovulation occurring in 1 of 29 (3%) cycles when UPA-EC was administered alone.

References available on request

Additional Important Counselling Points

 It is recommended that a pregnancy test is carried out if menstruation is delayed by more than 7 days after EC. After UPAEC, 75% of women had their next menstrual period at the expected time or within 7 days of the expected time. The majority of women also menstruate within 7 days of the expected time after LNG-EC.

 Studies have demonstrated a higher pregnancy rate after EC amongst women who have further UPSI in the same cycle than amongst women who do not have further UPSI.

 When (re)starting contraception 5 days after UPA-EC, it takes 7 days for the COC, ring, patch, and progesterone implant to take effect. It takes 2 days for the POP (traditional or desogestrel) to take effect. It takes Qlaira 9 days. Additional contraceptive precautions should be taken during this time.

her morning af ter

PRODUCT INFORMATION ellaOne® 30 mg film-coated tablet (ulipristal acetate). Refer to the SmPC for further information. INDICATION: Emergency contraception (EC) within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. DOSAGE: one 30mg tablet taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure. Another tablet should be taken if vomiting occurs within 3 hours of intake. Can be taken at any time during the menstrual cycle. Not recommended for women with severe hepatic impairment. CONTRAINDICATIONS: Hypersensitivity to the active substance or excipients. SPECIAL WARNINGS AND PRECAUTIONS: Occasional use only. Use reliable barrier method after use until next menstrual period. If next menstrual period is delayed >7 days or is abnormal or suggestive symptoms occur then perform pregnancy test. Consider ectopic pregnancy. If pregnancy confirmed, woman should contact their doctor. Concomitant use with EC containing levonorgestrel not recommended. Does not contraindicate the continued use of regular hormonal contraception but reliable barrier method should be used until next menstrual period. Not recommended in severe asthma treated by oral corticosteroids. Concomitant use of CYP3A4 inducers [e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John’s wort), rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine] not recommended (may decrease efficacy of ellaOne). Long term use of ritonavir not recommended. Not recommended for women who have used enzyme-inducing drugs in the past 4 weeks. Non-hormonal emergency contraception (i.e. a copper intrauterine device (Cu-IUD)) should be considered. Contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Contains

less than 1 mmol sodium (23 mg) per vial, essentially ‘sodium free’. FERTILITY, PREGNANCY AND LACTATION: Not intended for use during existing or suspected pregnancy. Limited human data does not suggest safety concern. Does not interrupt existing pregnancy. No teratogenic potential was observed; animal data insuﬃcient with regard to reproduction toxicity. Marketing Authorisation Holder maintains a pregnancy registry (www.hra-pregnancy-registry.com) to monitor outcomes of pregnancy in women exposed to ellaOne®. Patients and health care providers are encouraged to report any exposure. Ulipristal acetate is excreted in human breast milk; breastfeeding is not recommended for one week after intake. Breast milk should be expressed and discarded. A rapid return of fertility is likely following ellaOne use; regular contraception should be continued or initiated as soon as possible; subsequent acts of intercourse should be protected by reliable barrier method until next menstrual period. UNDESIRABLE EFFECTS: Always consult the SmPC before prescribing. Only the most common side eﬀects and those which are rare but may be serious are listed below. Most commonly reported adverse reactions: headache, nausea, abdominal pain and dysmenorrhea. Common (≥ 1/100 to <1/10): mood disorders, dizziness, vomiting, abdominal discomfort, myalgia, back pain, pelvic pain, breast tenderness and fatigue. Rare (≥1/10,000 to <1/1,000): ruptured ovarian cyst.

MARKETING AUTHORISATION HOLDER: Laboratoire HRA Pharma, 200 avenue de Paris 92320 Châtillon - France. MARKETED IN IRELAND BY: Chefaro Ireland DAC, The Sharp Building, 10-12 Hogan Place, Dublin 2, D02 TY74, Ireland MARKETING AUTHORISATION NUMBER(S): EU/1/09/522/003. LEGAL CATEGORY: Medicinal product not subject to medical prescription. Date of last revision of text: October 2023. Unique ID: IE/ELLA/0319.

REFERENCE: 1. Glasier A et al. Lancet 2010; 375 (9714): 555-62.

New Blood Test for Alzheimer’s Disease

Trinity researchers have examined the effectiveness of a new blood test which could change the way Alzheimer’s Disease is identified. The blood test (plasma p-tau217) detects the presence of ‘amyloid plaques’ that build up in the brain of people with Alzheimer’s Disease. In the Alzheimer’s brain, abnormal levels of this naturally occurring protein clump together to form plaques that disrupt normal cell function.

Research just published in the leading international journal Alzheimer’s Research & Therapy outlines a study undertaken in the Institute of Memory & Cognition at Tallaght University Hospital (TUH) which could change the way Alzheimer’s Disease is detected. Researchers wanted to know if a simple blood test would be easier and more accurate than a lumbar puncture (spinal tap), which currently is the only method to detect amyloid plaques. The lumbar puncture is invasive, and scans are limited in their availability. The use of blood tests has clear advantages over both of these methods being less invasive, more straightforward for patients, easier to scale up and less costly.

Using samples from the biobank at the TUH Institute of Memory and Cognition, study lead, Dr Adam

Dyer, examined the performance of the new blood test. Adam is a Geriatric Medicine Trainee at Tallaght University Hospital and Medical Gerontology, Trinity College Dublin. Patients who are undergoing a diagnostic lumbar puncture for the detection of Alzheimer’s disease at TUH opt to donate cerebrospinal fluid and blood samples for future research. This is crucial in examining the performance of these new blood tests in real-world clinical cohorts.

The research examined how well the new blood test performed in detecting the same proteins (in particular “amyloid” protein) that are looked for in cerebrospinal fluid in samples from the existing biobank

The potential for significant change in detection

Overall, the blood test was more

than 90pc as accurate as the outcome from lumbar punctures. Different blood test cut-off values were then examined and it was found that if - theoretically - the blood test was used in the future, over half of lumbar punctures could be avoided.

This has significant implications in terms of invasiveness, length of time to a diagnosis and also may reduce cost. Lumbar punctures are safe and well-tolerated as diagnostic procedures, however a small number of individuals may experience side-effects such as post lumbar-puncture headaches.

Commenting on the research

Dr. Dyer said, “This study found that blood tests such as plasma p-tau217 demonstrate excellent performance to detect the changes that are characteristic of

Alzheimer’s disease. In the future, clinical use of these blood tests may enable us to avoid invasive tests such as lumbar punctures in over half of individuals who currently have these procedures performed”. This research is one of a handful in the world to assess this in ‘real-world’ clinical cohorts and the first Irish study to examine the performance of these blood tests.”

Moving forward, the next step in this research is to examine if the performance of these blood tests can be matched in diagnostic laboratories. This would mean that patients referred can hopefully have a blood test in the first instance, and that those who clearly have a negative or positive result could avoiding the need for diagnostic lumbar puncture.

New Appointment at Johnson & Johnson

Johnson & Johnson Innovative Medicine has appointed Michaela Hagenhofer as General Manager of its commercial operations for Ireland. Michaela will be responsible for leading all aspects of the commercial business in Ireland, focused on driving sustainable business growth through enhanced access to innovative therapies.

Michaela brings a wealth of experience to her new role, having previously served as Commercial Director for Specialty Care at J&J Innovative Medicine in Austria. During her tenure, she achieved consistent business growth across key therapeutic areas including

immunology, central nervous system, and cardiopulmonary therapies, driven by a customercentric approach and a commitment to talent development. She has dedicated her career to date to the pharmaceutical

industry, having previously worked for Takeda, AbbVie and Merck in roles with increased responsibility across many therapy areas including haematology, oncology and gastroenterology.

Johnson & Johnson Innovative Medicine innovates with purpose to lead where medicine is going. Its ambition is to tackle the toughest health challenges, where patient need is highest. Currently, its research and development are focused on the areas of oncology, immunology, neuroscience, cardiopulmonary and speciality ophthalmology, with a commitment

to changing the standard of care including evaluation of new medicines and therapeutic interventions that are personalised for optimised clinical outcomes.

Based in Dublin, Michaela is enthusiastic about the opportunities that lie ahead. Commenting on her appointment, Michaela said, “Taking on the role of General Manager for Johnson & Johnson Innovative Medicine Commercial Operations Ireland is an exciting next chapter in my career. As a business, we are committed to leading where medicine is going, identifying the patients with the highest unmet needs and developing increasingly personalised care for specific subsets of patients. I am committed to continuing to collaborate with our talented team in Ireland to seek timely access to these innovative treatments, working in partnership with the Government, patient groups, the health service, academia and the wider industry to make a tangible difference in the lives of people, health systems and society here.”

Michaela Hagenhofer

Have News to Share?

We want to Hear from You

We want to celebrate and share the amazing work you’re doing in the community. If you have any exciting news, stories, or updates from your pharmacy, we’d love to hear about them! Whether it’s a heartwarming customer interaction, a community event you’re hosting, or any innovative services you’re offering, share the good vibes and let us spread the positivity.

Editorial 2024/25 Deadlines:

September Issue - 9th August

October Issue - 13th September

November Issue - 11th October

December Issue - 8th November

January 2025 Issue - 13th December

February Issue - 10th January

Contact the Editorial Director Kelly Jo Eastwood at: kelly-jo@ipn.ie Or Michelle Fullerton at: michelle@ipn.ie

ICO Host Annual Conference 2024

The Irish College of Ophthalmologists hosted their Annual Conference 2024 at the Knockranny House Hotel in Westport, Co Mayo from Wednesday 15th to Friday 17th May. Over 200 ophthalmologists gathered for the three-day scientific conference to hear the latest clinical and scientific developments in the speciality from eye experts at home and abroad.

Key symposia at this year’s conference focused on Vision and Strabismus, Orbit and Socket, and Sustainability in Ophthalmology.

Among the keynote guest speakers, the College was delighted to welcome Mr Ian Marsh, Consultant Ophthalmic Surgeon at the Liverpool University Hospital NHS Trust and Dr Arvind Chandna, Consultant Paediatric Ophthalmologist at Alder Hey Children’s Hospital, Liverpool and Senior Clinician Scientist at Smith Kettlewell Eye Research Institute, San Francisco to present at the Vision and Strabismus symposium, alongside Ms Kathryn McCreery, Consultant Ophthalmic Surgeon at Children’s Health Ireland at Crumlin Hospital.

In her talk, Ms McCreery discussed difficult paediatric ophthalmology and strabismus consultations including drop administration in children, evaluation of the child with autism and delivering bad news. The management of strabismus surgery complications and the informed consent process in paediatric and adult strabismus surgery was also discussed, with an emphasis on effective communication with children, their parents and adults in advance of undergoing strabismus surgery.

Mr Ian Marsh currently runs a comprehensive strabismus

service mainly for adults but also including more complex children squint at Liverpool University Hospital NHS Trust in Liverpool and spoke to delegates about decoding the process of strabismus management. Recent developments have included the introduction of Bupivacaine injections to permanently straighten eyes, the use of inferior medial rectus plication in near exotropia and since the Covid pandemic, a regular video clinic and a monthly local anaesthetic squint list.

Dr Arvind Chandna delivered a comprehensive talk on Cerebral Visual Impairment and a structured approach to managing the condition beyond visual acuity.

Dr Chandna conducts research programmes dealing with significant gaps in clinical and scientific knowledge of common childhood eye conditions with poor management outcomes, investigating them in collaboration with SKERI’s vision scientists. His talk outlined this investigation of visual brain neuroscience and oculomotor behaviour using eye tracking, photorefraction, psychophysics and visually evoked brain potentials in childhood eye disease.

Mr Manoj Parulekar, Consultant Ophthalmic Surgeon at the

Former international rugby player, Ian McKinley, is pictured during his keynote speech ‘SCNF - Second Chances Never Forget’ at the Irish College of Ophthalmologists ‘Eye Care in Focus 2023’ Conference on Tuesday September 19, The Gibson Hotel Dublin

Birmingham Women’s and Children’s NHS Foundation Trust and Oxford University Hospitals NHS Trust and Professor Geoffrey Rose, Consultant Orbital, Lacrimal and Plastic Reconstructive Surgeon at Moorfields Eye Hospital, London were guest speakers at the Orbit and Socket symposium. Mr Tim Fulcher, Consultant Ophthalmic Surgeon at the Mater Misericordiae University Hospital Dublin chaired and presented on the management of socket complications at this session.

Mr Parulekar outlined the clinical assessment, differential diagnosis and management of benign and malignant lesions of the paediatric orbit. He contributes to the paediatric ophthalmology service at the Birmingham Women’s and Children’s Hospital, the largest women’s and children’s hospitals in Europe, where he treats a wide range of childhood eye conditions including strabismus, paediatric cataracts and glaucoma, oculoplastics and neuro-ophthalmology, ocular oncology, and external eye diseases. He has special expertise in the treatment of eye cancers in children and is consultant ophthalmologist to the Birmingham National Retinoblastoma Unit, the largest nationally designated retinoblastoma center in the UK.

Mr Parulekar contributes to the ocular motility service (squints and complex eye movement disorders), and the neuro-ophthalmology service at the Oxford University Hospital where he provides a supra-regional service to Oxfordshire, Buckinghamshire, Berkshire and Wiltshire.

Prof Geoffrey E. Rose, Honorary Consultant Ophthalmic Surgeon,

Moorfields Eye Hospital, and Senior Research Fellow of the Biomedical Research Centre at the Institute of Ophthalmology, London, gave a detailed presentation on ‘Managing the Removal of an Eye’ at the Orbit and Socket symposium. In his talk, he discussed the problems that can occur with socket management and the alternatives to eye removal, the patient consent process and challenges which can occur as a result of “over promise” by the physician. Prof Rose addressed the mechanics of eye removal and how to manage (largely by prevention) the volume deficiency that would otherwise arise from the removal of the globe.

It was a great honour for the College to invite Professor Rose to deliver the Annual Mooney Lecture at the 2024 ICO Conference, which he presented on the evening of Wednesday 15th May.

Prof Rose’s lecture entitled “Trends in rehabilitation of patients with thyroid eye disease” considered what thyroid eye disease means, in practical terms, to the patient and the mechanism of the disease in terms of the underlying inflammatory mechanism, and the biomechanics of the condition.

Prof Rose outlined the historical treatment of thyroid eye disease in patients, up to the modern day advances and the changes in treatment approaches. Four decades ago, changes in treatment were largely directed to improving surgical techniques to allow a better restoration of function and appearance, with less injury to neighbouring tissues. Early immunosuppressive regimes were based on various regimes for systemic corticosteroids, either oral or intravenous (and occasionally intraorbital administration). More recently, the immune response has been mollified with monoclonal antibodies directed against the inflammatory mediators or cells and over the last 20 years, it has been shown that changes in thyroid eye disease appear to be produced through an immune activation of the TSH-receptor and IGF1-receptors.

On the final day of the conference, a dedicated symposium on Sustainability in Ophthalmology welcomed experts from both

50 Conference

home and overseas to share their knowledge on ways to minimise the carbon footprint of the speciality and plan for the future from both an environmental and sustainable practice perspective. Healthcare is a notable contributor to greenhouse gas emissions, accounting for an estimated 5% of total emissions globally. The ophthalmic field, like many others in healthcare, has a significant environmental footprint. From the disposal of single-use instruments to the energy consumption of diagnostic equipment, the impact is significant.

Miss Radhika Rampat, Consultant Ophthalmic Surgeon at the Royal Free London NHS Trust outlined the sustainability in the ophthalmology journey so far of the American European Congress Of Ophthalmic Surgery - Green Working Group, examining “How can I act locally and share globally”. She examined what has been achieved to date in eye clinics and theatres locally and internationally in the efforts to reduce the carbon footprint in the specialty. Miss Rampat is the co-chair of AECOS Green Working Group.

Ireland is among the major healthcare emitters per capita internationally. The ICO welcomed Dr Philip Crowley, National Director of Strategy and Research and HSE National Lead for Climate Change who spoke to delegates about the HSE Climate Action Strategy 2023-2050 being adopted to reduce emissions and protect population health in the Irish healthcare system.

The strategy is one of the first national health service climate strategies globally, and Dr

PIctured at the Irish College of Ophthalmologists ‘Eye Care in Focus 2023’ Conference, The Gibson Hotel, Tuesday 19 September:

(L-R) keynote speakers at the Glaucoma clinical education session Dr Robert Harper, Optometrist, Manchester Royal Eye Hospital and Honorary Professor of Optometry, School of Health Sciences, University of Manchester; Dr Margaret Morgan, Consultant Medical Ophthalmologist, CHO 7 and Royal Victoria Eye and Ear Hospital, Dublin; Ms Elaine Brennan; Clinical Nurse Specialist, Glaucoma Clinic, Beaumont Hospital Eye Department with ICO President, Mr John Doris

Crowley outlined the progress on implementation of its target to achieve net-zero emissions for the HSE by 2050, the relevant actions for ophthalmology practice and the work to mobilise health service staff.

Dr Emilie Mahon, RCSI Ophthalmology Clinical Tutor at the Royal Victoria Eye and Ear Hospital, outlined the findings of her research on the ecological impact of phacoemulsification cataract surgery where she examined the single-use items consumption and the results concerning the carbon footprint of cataract surgery in the Eye and Ear Hospital.

Mr Arthur Cummings, Consultant Ophthalmologist at the Wellington Eye Clinic in Dublin looked at the practice side of sustainability in ophthalmology in light of the

growing burden of ophthalmic needs building globally while the number of ophthalmologists is decreasing.

Mr Cummings highlighted the need for the specialty to become more efficient and effective while the shortage of ophthalmologists is addressed. His talk reviewed three areas that can help achieve greater efficacy and efficiency, namely system design, artificial intelligence and the role of the allied health professional team in leading to improvements in making ophthalmic practice sustainable.

Workshop sessions, paper and poster presentations and the European Society of Ophthalmology (SOE) Lecture 2024 presented by Mr Michéal O’Rourke, Royal Victoria Eye and Ear Hospital, St James’s Hospital and Children’s Health Ireland at Crumlin, Dublin on the topic of Paediatric Oculoplastics also featured on the three day conference programme.

The Barbara Knox Medal for Best Paper was awarded to Dr Shane O’Regan for his paper entitled

“Eyes on Spina Bifida: A TwoDecade Retrospective Exploration of Ophthalmic Manifestations in Paediatric Patients at Temple Street Children’s University Hospital, Dublin.”

The William Wilde Medal for Best Poster was awarded to Dr Patrick Murtagh for his poster “Uveal Melanoma Patients Treated with Iodine Plaque versus Ruthenium Plaque versus Proton Beam Radiation: A Ten-Year Review.”

Dr Murtagh was presented with his medal by Professor Brendan Kelly, Consultant Psychiatrist, Tallaght University Hospital, Dublin and Professor of Psychiatry at Trinity College Dublin who shared with the audience his insights on human behaviours and reactions to perceived challenges in his fascinating talk on “Pandemics in Ireland, and Lessons Learned from Covid (If Any)”

Prof Kelly’s recently published book ‘Resilience: Lessons from Sir William Wilde on Life After Covid’ reflects on the pandemic in Ireland and what we might learn as a society and as individuals from the experience.

Former international rugby player, Ian McKinley is pictured with Mr John Doris, President, Irish College of Ophthalmologists (ICO) and Ms Janice Brady, Consultant Ophthalmic Surgeon, University Hospital Waterford at the ICO ‘Eye Care in Focus 2023’ Conference on Tuesday September 19, The Gibson Hotel Dublin

The ICO announced the publication of its Annual Report for 2023 at the conference in Westport. The ICO is a registered Irish charity. The organisation is committed to the advancement and improvement of eye health and patient safety and works to protect, enhance and promote the highest standards in the delivery of eye care

The Annual Report 2023 outlines the activities undertaken by the College and finances for that year.

Understanding Autoimmune Disease

Researchers from the School of Medicine and the ADAPT Centre at the School of Computer Science and Statistics at Trinity College Dublin have made a significant breakthrough in vasculitis research, in collaboration with researchers at Lund University.

The findings, recently published in The Lancet Rheumatology, offer new insights into the diagnosis and treatment of systemic vasculitis, a group of rare and complex autoimmune diseases.

The study, part of the EU-funded FAIRVASC project, leverages advanced artificial intelligence (AI) and big data techniques to address critical challenges in diagnosing and treating systemic vasculitis. FAIRVASC connects vasculitis patient registries across Europe, enabling seamless data sharing and advanced analysis to drive forward research and improve patient care.

Focusing on antineutrophil cytoplasm antibody (ANCA)associated vasculitis, the research introduces a novel approach to classifying this disease using a

federated dataset ten times larger than previous studies.

Access to this much larger dataset enabled more detailed analysis, revealing previously unidentified disease clusters. This new classification method offers more accurate predictions of outcomes like overall survival and kidney health, paving the way for more personalised treatment strategies that can significantly enhance patient care.

Professor Mark Little, Professor of Nephrology and Consultant Nephrologist at Trinity College Dublin, and Tallaght and Beaumont Hospitals, said, “Our research shows that by leveraging advanced AI systems and broad datasets, we can uncover new patterns of this rare autoimmune disease, which have impacts on the probability of

adverse outcomes. This allows us to focus potentially toxic therapies on those most likely to benefit.

“Such progress was possible only through a multidisciplinary approach and with direct involvement of patients with lived experience of the condition, and this collaborative project has successfully brought together experts in medicine, computer science, and statistics.”

Professor Declan O’Sullivan, ADAPT Principal Investigator and Professor in Computer Science at Trinity, added, “I am delighted to see the research that we focus on in our group, Knowledge Graphs for data integration, is bringing impact in advancing medical research. In particular here, federating patient registries for rare diseases.”

The study highlights the transformative potential of AI in medical research, particularly in addressing the complexities of rare diseases, where it has previously been impossible to generate sufficiently large cohorts to enable meaningful research.

By enabling more precise identification of disease patterns, AI can revolutionise how clinicians approach diagnosis and treatment, offering hope for better outcomes not only for vasculitis patients but also for those suffering from other rare and challenging diseases. This research provides a blueprint for using advanced technologies to tackle similar challenges in the broader field of rare diseases, potentially leading to breakthroughs that could benefit countless patients worldwide.

The first ophthalmologist approved eye makeup remover is now available

Leading eyecare company, Scope Eyecare has launched a first-of-its-kind make-up remover for sensitive eyes. Optase Life Sensitive Eye Makeup Remover incorporates a unique, patented Ionised Water Technology that offers a gentle yet effective solution to eye makeup removal, while respecting the ocular surface and promoting a protective skin barrier.

Optase Life Sensitive Eye Makeup Remover is scientifically formulated to address the challenges faced by individuals with sensitive eyes—a condition affecting approximately 46% of the population.It not only removes makeup effectively but does so in a way that respects the delicate balance of the skin and eye’s natural defences.

Product Innovations and Benefits:

• Patented Ionised Water Technology: This innovative technology utilises negatively charged ions that effectively attract and encapsulate makeup particles, allowing for their gentle removal without the need for harsh rubbing or potentially irritating surfactants.

• Enhanced Skin Barrier Protection: Recent studies have demonstrated that Optase Life’s patented ionised water supports the natural ceramides in the skin, vital components in maintaining the integrity of the skin’s barrier

function, reducing transepidermal water loss by 14%.

• Clinically Approved: Rigorously tested by dermatologists and ophthalmologists. It is free from preservatives, fragrances, and allergens, making it suitable for even the most sensitive skin types.

Dr. Elizabeth Hawkes, a leading ophthalmologist, states, “The introduction of Optase Life Sensitive Eye Makeup Remover marks a significant advancement in the care regimen for individuals with sensitive eyes. Its ability to cleanse effectively without disrupting the ocular surface and dermal surfaces is unprecedented in eyecare.”

The launch of this product is particularly timely, given the increasing prevalence of eye irritations exacerbated by cosmetic use. Optase Life offers a soothing, hydrating solution that minimises the risk of irritation and supports the natural function of the skin.

Life Sensitive Eye

sensitive eye sufferers. For stockist information, please contact Scope Eyecare to learn more.

Optase

Makeup Remover is set to become a bathroom cupboard staple for

Youth Mental Health in Crisis

New research reveals an “unprecedented” mental health crisis among young people, with calls to make the matter an “international health priority”.

Intergenerational inequality, unregulated social media, insecure employment and the climate crisis are driving a global surge in mental ill health among youth, according to a new study published in The Lancet Psychiatry Journal.

Evidence suggests that in many countries, the mental health of young people has been declining over the past two decades, and changes in many societies are increasing mental ill health.

The report was released by Orygen - Australia’s Centre of Excellence in Youth Mental Health

-following years of extensive research and was developed by an international team of researchers, including Professor Barbara Dooley, Dean of Graduate Studies & Deputy Registrar at University College Dublin.

Professor Patrick McGorry, lead author of the report and Executive Director of Orygen, the new study is a “major step” towards the recognition of youth mental health as an “international health priority”.

According to the research, mental illness accounts for 45% of the overall burden of disease

in individuals aged 10-24 years globally.

It also found the need for mental health support for this age bracket has risen by 50% in the last two decades.

Speaking on RTÉ Radio One’s Drivetime, Professor Dooley said there was an urgent need to address the driving factors behind the growth in mental ill health and improve mental health treatments for young people as mental illnesses have their peak onset at age 15 years.

Enhancing Care for Patients with Lower Urinary Tract Symptoms

The introduction of a Nurse-Led Urology Clinic at Roscommon University Hospital for Lower Urinary Tract Symptoms (LUTS) has significantly enhanced patient care, reduced wait times, while also reducing the number of patients who require consultant urologist review.

The clinic was established to provide a focused targeted urological assessment of symptoms, as well as treatment, support, and education to enable patients to manage their urological condition without surgery and to reduce wait times for LUTS assessment and management.

Prior to the commencement of the Advanced Nurse Practitioner (ANP) LUTS clinic in February, patients requiring ongoing nursing management or intervention were referred to University Hospital

Galway. Wait times from referral to review have decreased from 1-2 years to 6-8 weeks at present, with 156 new patients assessed between February and June.

LUTS and specifically male LUTS is one of the most prevalent complaints presenting to urology outpatients. Research conducted by the National Clinical Programme in Surgery (NCPS) revealed that male LUTS is one of the more common causes for referral to a urologist in the Saolta University Health Care Group.

Mental Health Bill

Minister for Mental Health and Older People, Mary Butler, hasannounced the publication of the Mental Health Bill 2024 , which was approved by Government on 24 July.

The development of the new Mental Health Bill, which will replace the existing Mental Health Acts 2001 – 2022, is a longstanding priority of the Department of Health and features in the current Programme for Government.

Minister Butler said:

“I am delighted to publish this important piece of legislation today. The publication of the Bill is an important milestone, and I am happy to deliver on my commitment to read the Bill for the next steps in the legislative process. Today’s publication means that the Bill will be ready for introduction to the Oireachtas as soon as possible on the return of the Dáil in September.

Michelle Healy, Advanced Nurse Practitioner and Clinic Lead for the Lower Urinary Tract Symptoms (LUTS) Clinic at Roscommon University Hospital

Professor Eamonn Rogers, Consultant Urologist at Saolta University Health Care Group and Co-Lead National Clinical Programme in Surgery said, “The Nurse-Led Urology Clinic is one of the strategies of the Model of Care in Urology developed by the NCPS to improve access for urological care and to reduce waiting times to be seen in clinics.”

Michelle Healy, Advanced Nurse Practitioner and Clinic

Lead, stated, “We have an excellent urology service here at Roscommon University Hospital, between the Rapid Access Haematuria service and the LUTS service, and to have two visiting Consultant Urologists from University Hospital Galway aligned to service and supporting us, is fantastic.”

“We are providing care to patients as close to home as possible and our patients always comment on how easy it is to travel to Roscommon, and how tremendous the service is. So it’s wonderful to see that the clinic is already making a significant difference in the lives of our patients.

“The Bill will replace the 2001 Act, introducing a more modern, person-centred approach to mental health legislation and will put in place a more robust framework in which our mental health services will be delivered and regulated. Importantly, the Bill introduces the regulation of community mental health services, including CAMHS, for the first time.”

Minister Butler added, “The Bill contains numerous important measures, which will have a tangible beneficial impact on individuals accessing mental health services, empowering them to play a more active role in making decisions about their care and treatment.

“The Bill is lengthy and complex, containing 202 sections, and I look forward to guiding it through the legislative process and to bringing it to Committee Stage in the Autumn.”

The Bill was subject to extensive consultation during the current drafting process and prior to the publication of the General Scheme in July 2021, including ongoing consultation with the Mental Health Commission, the Health Service Executive (HSE) and other Government Departments and stakeholders.

Specialist infant formula is one area where pharmacists could provide a valuable service to those mothers who are unable to breastfeed and whose babies have an intolerance or a sensitivity to regular formula milk, or for those women whose baby has a problem such as reflux, colic or constipation.

Topic Team Training – Infant Feeding

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

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

Parents welcome the advice of healthcare professionals for infant feeding and the community pharmacy will be the first call when looking for guidance.

Feeding in the first 2 years of a child’s life are particularly important: research has shown that adequate nutrition during this time decreases morbidity and mortality, reduces the risk of chronic disease, and contributes to optimal development.

Breast milk, when it is the sole source of nutrition for infants in the first six months of life, plays a critical role in development.

Pharmacists and their teams are ideally placed to provide advice and support to mothers when it comes to infant feeding. From giving practical tips and support on breastfeeding to identifying and advising on potential problems, the pharmacy team can make a real difference to young families in those early months

Informed choice must be promoted, many maternity and infant experts advise.

Consider:

Many pharmacies can benefit from adopting a merchandising approach, with clear signposting to ‘Ask the pharmacist for advice.’ There has been an increase in the number of babies who do not thrive on standard formulas, which is why much of the growth in the infant formula market over the past year has been driven by an increase in purchases of specialist milks, aimed at addressing feeding problems.

Table One: Milk for Infants

0-6 months 6-12 months After 12 months

Breast or infant Formula Yes Yes Yes

Follow-on milk No Yes Yes

Whole cows’ milk No No Yes

Semi-skimmed or skimmed milk No No No

Formula Feeding

Who? Newborn babies

milks, as this can be bewildering for new parents. While leaflets on bottle feeding are essential, so are one-to-one discussions.

What are the symptoms? Hiccups, coughing, sudden crying, bringing up milk, poor weight gain

How long has the patient had the symptoms? Can occur up to age 18 months

There is a range of infant formulas available over-the-counter and either a whey or casein based formula is a suitable choice for infants from birth to the age of 12 months. Follow-on formulas, which contain more iron and vitamin D than ordinary formulas, are available for infants over the age of six months.

Cows’ milk is not suitable as a main drink for children under the age of 12 months. It contains little iron and vitamin D and may lead to intestinal blood loss in some children. Skimmed and semi-skimmed milks should not be used in infancy because of their low energy content. Semiskimmed milk may be used from the age of 2 years where it is the milk used in the household and the infant’s diet is varied. However, skimmed milk should not be used under the age of 5 years. Fruit juice is not necessary, but helps the absorption of iron from fruit, vegetables and cereals.

It is important to remember that many parents do not receive instruction on appropriate techniques for making up bottles; if formula preparation is not done properly, the baby may be at risk of dehydration and over- or under-nutrition.

Parents who bottle-feed can feel that they are not given enough impartial information about formula milks. Pharmacy teams should know the differences between the different types of

 Am I aware of the regulations around infant and follow-on formula?

 The differences between different types of infant formula?

 Is the pharmacy area set-up for discreet conversations with customers?

 Do we stock an efficient range of formula? Do I, and my team, know enough about them to recommend them?

 Are we are of the permitted sources of protein on which formula is based?

Whey Based Formulae - These are similar to breastmilk because the protein content is made up of more whey than casein. However, the total protein content of infant formulae is higher than breastmilk and as a result, infant formulae are not as digestible as breastmilk. These formulae are the most suitable for newborn and older infants.

Action already taken? Mums may already have tried switching feeds, feeding times, holding baby upright

Casein Based Formulae - Babies fed casein based formulae may have to work harder to digest each feed. This means that baby may sleep more - All babies need time every day to be awake and alert, in order for them to grow and develop.

“Follow-on” Milks - These are made from modified cow’s milk with extra iron and vitamins.

Soya Based Formulae - Soya based formulae and other specialised formulae should not be used without the advice of a dietician or doctor. All infant formulae on the Irish market must conform to the same EU standards and provide the same nutritional value. There should be no reason to change a baby from one “type” of formula to another.

Key Points:

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

 The age of use appropriate daily reference intake values

 The recent reduction in Vitamin D

 Permitted carbohydrates and required minerals and vitamins

 Labelling requirements and the promotion of breastfeeding over formula

Actions:

 Ensure the pharmacy team are aware of the benefits of breastfeeding and the different formulas on the market

 Ensure efficient sign posting to discreet consultation areas within the pharmacy for further help and advice

 Check that all pharmacy team members are able to understand the different stages of feeding, infant nutrition and development at each stage

 Keep products merchandised together, along with related products

 Ensure that this important category is fully stocked at all times and merchandising plans are amended based on time of year

 Train the team to meet all the above considerations

Bottles

Conception & Pregnancy

Pregnancy and Contraception Care in Pharmacy

Pre-Pregnancy & Fertility

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

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

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

Factors Affecting Fertility

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

strongest in their mid-twenties and starts to decrease after the age of 40.

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

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

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

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

Diet & Lifestyle: The HSE recommends all women begin taking folic acid for at least 3 months before conception. There are number of other vitamins, minerals and amino acids that are known to be beneficial to the reproductive system, however

it can be difficult to get all of these nutrients in the diet in today’s busy world. This is where supplements can help, by providing extra support needed to support good pre-conception health.

How Do Fertility Supplements Work?

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

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

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

Egg quality can be enhanced if it is released into a healthy nutritious environment. Fostering a good

diet and ensuring that you are taking the essential nutrients can positively affect the health of your eggs and subsequently the developing foetus.

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

Key Nutrients for Conception:

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

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

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

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

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

Antioxidants such as Co-Q10 are important for reproduction. CoQ10 is a powerful antioxidant and energy powerhouse. It is present in the membrane of almost every cell in the body.

Improved Absorption: Readily absorbed and used by the body.

Effective for all: Works regardless of genetic makeup.

Higher Bioavailability: Unique bioavailable composition for daily use.

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

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

Heartburn and Indigestion

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

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

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

2. During the latter stages of pregnancy symptoms can also be caused by the baby physically putting pressure on the woman’s digestive tract.

Although harmless to the baby, heartburn and indigestion can be painful and uncomfortable for expectant mothers and pharmacists can advise patients that eating a healthy diet and sitting and/or sleeping in a more upright position can help ease heartburn and indigestion.

Fatigue

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

A number of tips to give expectant mums include:

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

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

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

Morning Sickness

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

Although it’s not known exactly what causes expectant mums to feel nauseous, it’s most likely that the feelings of nausea are all down to hormones, particularly Beta hCG, although it is thought that it can be due to a lack of vitamin B6, too.

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

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

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

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

4. Try food or drinks that contain ginger.

5. Wearing acupressure bands throughout the day.

Sciatica and Muscular Back Pain

As many as 98% of women will suffer from muscular back pain at some stage during their pregnancy. The pain is caused by the additional weight and changes in the body during pregnancy; hormonal changes can cause

ligaments which support the spine to become loose, which puts more pressure on the lower back.

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

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

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

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

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

Medication taking whilst pregnant

As 50% of pregnancies are unplanned, a woman often discovers she is pregnant while already taking medication and visits a pharmacy which is easily accessible, to enquire if she has harmed her baby by this action.

Whilst studies show there may be a lack of adequate information regarding use of certain medications during pregnancy, it has been suggested that pharmacists should be able to integrate available information with their medication expertise, to make appropriate individual risk/ benefit decisions. This requires active engagement with pregnant women, rather than automatically referring them to their physician.

The trimester of the pregnancy often plays an important part in whether medications can be taken, for example some medicines can be dangerous to take in the first three months but safe in the second or third, or vice versa.

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

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

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Get Moving on Sports Injuries

The arrival of summer evokes the promise of sun-filled days, allowing us to enjoy the outdoors. Furthermore, with several big sporting events on the calendar, such as Wimbledon and the Open Golf, many are inspired to dust off their trainers.

With this upsurge in activity, comes an increased risk of sports-related injuries, presenting community pharmacists and their teams with an opportunity to treat and help with minor sports injuries.

Knowing how to identify common sporting injuries and provide specific advice to patients on their effective management, including the role of over-the-counter treatments, as well as when to refer for specialist assessment and treatment, can help many steer clear of long-term muscular pain and joint damage.

A worryingly high percentage of people simply ignore niggling sports injuries or treat them incorrectly, according to research. Research also show that men are three times more likely to injure themselves playing sport than women.

Not only is physical inactivity linked to poor cardiovascular fitness and obesity, the World Health Organisation (WHO) estimates it to be the main cause for approximately 21–25% of breast and colon cancers, 27% of diabetes and approximately 30% of ischaemic heart disease burden.

Acute and Chronic Injuries

Sport injuries can be acute or chronic. Acute sports injuries occur as a result of a sudden impact or awkward movement. Examples include a cut to the skin or a sprained ankle. Chronic sports injuries develop over time, often due to continual use of the same joints or muscle groups.

Written by Denis O’Driscoll, Superintendent Pharmacist, LloydsPharmacy

Chronic sports injuries can occur due to bad technique or occasionally structural abnormalities, such as an inherited bone or muscle problem. These injuries should be further investigated by a medical professional to determine the cause and to prevent the injury getting worse.

Some of the most common sports injuries include:

• Sprains,

• Strains,

• Cuts and bruises,

• Bone fractures and breaks,

• Tendonitis (inflammation of a tendon),

• Blisters, and

• Head injuries.

Whilst the figures regarding sports injury presentation to A&E are of note, community pharmacies will collectively see many more minor sports injuries.

Common risk factors for sports injury include inadequate warm up, fatigue, over intensive training, unsuitable equipment and a changed environment (e.g. very hot weather, poor lighting, or physical contact with another person or equipment).

Injury prevention can be achieved through dynamic stretching before activity.

A sprain or a twisted joint can happen in most limbs but most

commonly in the ankle. One or more ligaments of the ankle experience excessive stress and become abnormally stretched when the foot is moved past its normal range of motion. The sudden excess stress puts a strain on the ligaments. Once the strain goes beyond the yield point, the ligament becomes damaged, or sprained.

Blood vessels leak fluid into the joint, starting from the site of the injury. Increased blood flow and inflammatory exudates including white blood cells, macrophages and leukocytes migrate to the area, causing both inflammation and swelling.

This results in pain, sensitivity and throbbing as the nerves are further sensitised. As further blood flow increases to the site, the area looks a lot redder, feels a lot warmer, becomes more sensitive and there is a decrease in mobility.

Use non-steroidal antiinflammatory drugs (NSAIDs) to treat pain, reduce any localised heat, decrease swelling and improve mobility. Oral pain relief normally starts soon after the first dose and the full analgesic effect occurs within a week.

Topical NSAIDs can be applied directly to the site of the injury. Topically applied NSAIDs penetrate the skin and result in therapeutically significant concentrations in underlying inflamed soft tissues, joints and synovial fluid, probably entering the synovial joint mainly via systemic circulation.

In tendinopathies (painful tendons), inflammation plays a lesser role and so NSAIDs have little influence on healing but they can help with short-term analgesia. If used in the first seven days inn sprains, strains or ligament tears NSAIDs can also be used to limit pain and swelling thus increasing the chances of the patient regaining function and returning to activity sooner.

Patients should be advised to take NSAIDs with food. Following that advice, short-term use of NSAIDs is safe but patients should be advised that long-term use increases the risks of systemic side effects (such as gastrointestinal and cardiovascular effects).

Tennis elbow (epicondylitis) is a painful condition that affects the

outside of the elbow. It is caused by strenuous overuse of the muscles and tendons of the forearm and around the elbow joint.

The symptoms of tennis elbow include:

• tenderness around the elbow, and

• pain when moving the elbow.

Tennis elbow is caused by repetitive movement of the muscles in the lower arm. It can be treated with anti-inflammatory medication, an elbow splint to support the arm or a cortisone injection. Sufferers should be advised to avoid activities that cause pain and, in a sporting setting, obtain advice to correct faulty technique.

Tendonitis is inflammation (swelling) of a tendon. Symptoms of tendonitis include:

• swelling, redness and pain at the injured area,

• restricted movement of the affected area, and sometimes

• a change in appearance of the affected area, such as a lump or a visible change in position of a limb.

Tendonitis is a fairly common injury that can result from a strain or tear in a tendon. Tendonitis can occur in the tendons around the shoulder, elbow, wrist, finger, thigh, knee or the back of the heel (Achilles tendonitis).

Blisters are a common minor injury caused by friction on soft skin. Endurance athletes, such as long-distance runners, sometimes develop blisters on their feet. Rowers are at risk of developing blisters on the palms of their hands.

Although painful, most blisters will heal on their own unless they become infected, but they can be easily prevented in the first place by covering tender spots with a friction-resistant dressing or plaster. If they do occur, then specialist blister plasters, which claim to aid rapid healing by absorbing the fluid, protecting skin from bacteria and helping relieve the pain of friction and pressure, can be used.

Remind customers who have diabetes to be particularly vigilant when checking for blisters, as their

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62 Sports Injuries

foot injuries take longer to heal due to poorer blood circulation.

Athlete’s foot (tinea pedis) is a fungal infection that usually begins between the toes.

Symptoms include itching or burning and flaking skin, particularly between the toes, although the whole foot can be affected. The condition can be treated with products containing fungicidal or fungistatic ingredients. Making sure the feet are completely dry after washing; regularly changing footwear and wearing cotton socks can help ensure feet are less fungus-friendly.

Role of the Pharmacist

Two approaches exist for the immediate treatment of acute injuries, the main one being a simple five-step protocol, PRICE (P rotection, R est, I ce, C ompression, E levation). Rest after injury is usually considered appropriate for the first 48–72 hours. During this time, non-weight bearing is usually recommended and crutches or slings can provide support. After 48 hours, MICE (M ovement, I ce, C ompression, E levation) can be introduced, with gentle movement replacing rest. If pain is experienced on repetition of gentle movement, or if there is constant pain, then rest should continue for another 24 hours before the introduction of movement is tried again. If this is unsuccessful, referral to a GP should be considered. Earlier referral may be advised if pain is particularly severe.

Points to consider when taking a history from the patient include:

• Was the patient treated immediately or later after the injury?

• What treatment was received?

• Was the patient able to continue with their activity?

• What was the intensity of the activity leading up to sustaining the injury?

• Has this or any other injury occurred before?

• Is this an acute or chronic injury? Injuries to the head, cervical spine, or the thoracic or abdominal organs should be treated as potentially life-threatening and referred to secondary care urgently. A patient with suspected concussion following a blow to the head, face, neck or where an ‘impulsive’ force may be transmitted to the head, who presents subsequently with changes in behaviour, vomiting, dizziness, headache, doublevision or excessive drowsiness requires urgent medical assessment.

Treating Cuts and Scrapes

Minor scrapes and cuts are easily treated at home with basic wound-care or first-aid supplies. Because cuts can happen at any time, every home should have tweezers, gauze pads, bandages, and antibiotic ointment.

Here are some steps that pharmacists should tell patients to follow in treating cuts at home:

• Rinse a cut with cool water

• Wash around the cut with soap; avoidgettingsoapinto the wound

• Remove dirt and debris from the wound with tweezers; clean the tweezers with rubbing alcohol before using them

• Apply direct pressure with a clean gauze pad to a bleeding cut

• Treat the cut with antibiotic ointment

• Cover the cut with a bandage (deeper cuts may require a butterfly bandage)

• Do not pick at a scab while a cut is healing

Treating Bruises

Although bruises can be painful, treatment is limited. The best care for bruises involves rest and ice. Ice stops blood flow to the injury site, thus limiting the size of the bruise. Rest allows the site to heal.

Here are some further guidelines for patients for treating bruises at home:

• Apply ice packs or cold compresses as soon as possible

• Reapply ice packs every hour for 10-15 minutes during the first day, if needed

• With bruised legs or feet, elevate the legs as much as possible during the first day

• Take acetaminophen, if needed, for pain; do not take aspirin

• With large bruises, limit activity during the first day

• Use heat packs after 48 hours to promote healing

Here are some signs that bruises need medical attention:

• The bruise swells

• The bruise does not start to fade within a week

• The bruise occurs easily or for no obvious reason

Sports Injuries are one of the most common presenting to the pharmacy with pain. The are are three OTC oral analgesics available.

Aspirin

• Analgesic

• Antipyretic (reduces a fever)

• Anti-inflammatory

• Contra-indicated in under 16s

• Refer to pharmacist for patients on anticoagulants (blood thinners)

• Refer to pharmacist for patients with a history of gastrointestinal symptoms

Paracetamol

• Analgesic

• Antipyretic

• First line agent for pain and fever in children over 2 months

• Not an anti-inflammatory

• Caution not to take other products that contain paracetamol. Always read the label!

• Licensed for use in pregnancy when required Ibuprofen

• Analgesic

• Antipyretic

• Anti-inflammatory. Ibuprofen is a Non Steroidal Anti-Inflammatory Drug (NSAID).

• Anti-inflammatory effect may take more than one dose but analgesic effect is immediate

• For children from 3 months Diclofenac

• Analgesic

• Antipyretic

• Anti-inflammatory (NSAID) –Diclofenac is more potent than Ibuprofen

• Typically administered in topical form

One solution for muscle and joint pain

Reduces pain and inflammation to improve physical function

Diclofenac gel provides superior pain relief compared with ibuprofen gel*

Available in 100g and 50g pack sizes. Always read the label. Suitable for 14+ years.

Indicated for mild to moderate pain from acute strains, sprains or contusions following blunt trauma.

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

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

Mpox – Key Facts for Pharmacy

On 14 August 2024, the World Health Organisation announced that an upsurge of mpox in the Democratic Republic of the Congo (DRC) and a growing number of countries in Africa constitutes a public health emergency of international concern (PHEIC) under International Health Regulations (IHR).

This definition implies that a situation that is:

• serious, sudden, unusual or unexpected;

• carries implications for public health beyond the affected State’s national border; and

• may require immediate international action.

Mpox is a disease with symptoms similar to smallpox. It can be transmitted by animals and humans, through contact with bodily fluids, lesions on the skin or on internal mucosal surfaces, respiratory droplets and via contaminated objects. Most people fully recover from this illness.

Pharmacists may find Key facts from the WHO of use below.

Overview

Mpox is an infectious disease that can cause a painful rash, enlarged lymph nodes, fever, headache, muscle ache, back pain and low energy. Most people fully recover, but some get very sick.

Mpox is caused by the monkeypox virus (MPXV). It is an enveloped double-stranded DNA virus of the Orthopoxvirus genus in the Poxviridae family, which includes variola, cowpox, vaccinia and other viruses. There are two distinct clades of the virus: clade I (with subclades Ia and Ib) and clade II (with subclades IIa and IIb).

A global outbreak of clade IIb began in 2022 and continues to this day, including in some African countries. There are also growing outbreaks of clades Ia and Ib affecting the Democratic Republic of the Congo and other countries in Africa. As of August 2024, clade Ib has also been detected beyond Africa.

The natural reservoir of the virus is unknown, but various small mammals such as squirrels and monkeys are susceptible.

Transmission

Mpox spreads from person to person mainly through close contact with someone who has mpox, including members of a household. Close contact includes skin-to-skin (such as touching or sex) and mouth-to-mouth or mouth-to-skin contact (such as kissing), and it can also include

being face-to-face with someone who has mpox (such as talking or breathing close to one another, which can generate infectious respiratory particles).

People with multiple sexual partners are at higher risk of acquiring mpox.

People can also contract mpox from contaminated objects such as clothing or linen, through needle injuries in health care, or i n community settings such as tattoo parlours.

During pregnancy or birth, the virus may be passed to the baby. Contracting mpox during pregnancy can be dangerous for the fetus or newborn infant and can lead to loss of the pregnancy, stillbirth, death of the newborn, or complications for the parent.

Animal-to-human transmission of mpox occurs from infected animals to humans from bites or scratches, or during activities such as hunting, skinning, trapping, cooking, playing with carcasses or eating animals. The animal reservoir of the monkeypox virus remains unknown and further studies are underway.

More research is needed on how mpox spreads during outbreaks in different settings and under different conditions.

Signs and symptoms

Mpox causes signs and symptoms which usually begin within a week but can start 1–21 days after exposure. Symptoms typically last 2–4 weeks but may last longer in someone with a weakened immune system.

Common symptoms of mpox are:

• rash

• fever

• sore throat

• headache

• muscle aches

• back pain

• low energy

• swollen lymph nodes. For some people, the first symptom of mpox is a rash, while others may have fever, muscle aches or sore throat first.

The mpox rash often begins on the face and spreads over the body, extending to the palms of the hands and soles of the feet. It can also start on other parts of the body where contact was made, such as the genitals. It starts as a flat sore, which develops into a blister filled with liquid that may be itchy or painful. As the rash heals, the lesions dry up, crust over and fall off.

Some people may have one or a few skin lesions and others have hundreds or more. These can appear anywhere on the body including:

• palms of hands and soles of feet

• face, mouth and throat

• groin and genital areas

• anus.

Some people also have painful swelling of their rectum (proctitis) or pain and difficulty when peeing (dysuria) or when swallowing.

People with mpox can pass the disease on to others until all sores have healed and a new layer of skin has formed. Some people can be infected without developing any symptoms. Although getting mpox from someone who is asymptomatic (not showing symptoms) has been reported, information is still limited on how common it is.

Children, pregnant people and people with weak immune systems, including people living with HIV that is not well controlled, are at higher risk for serious illness and death due to complications from mpox.

Some people with mpox become very sick. For example, the skin can become infected with bacteria, leading to abscesses or serious skin damage. Other complications

include pneumonia; corneal infection with loss of vision; pain or difficulty swallowing; vomiting and diarrhoea causing dehydration or malnutrition; and infections of the blood (sepsis), brain (encephalitis), heart (myocarditis), rectum (proctitis), genital organs (balanitis) or urinary passages (urethritis). Mpox can be fatal in some cases.

Diagnosis

Identifying mpox can be difficult because other infections and conditions can look similar. It is important to distinguish mpox from chickenpox, measles, bacterial skin infections, scabies, herpes, syphilis, other sexually transmitted infections, and medicationassociated allergies. Someone with mpox may also have another sexually transmitted infection at the same time, such as syphilis or herpes. Alternatively, a child with suspected mpox may also have chickenpox. For these reasons, testing is key for people to get care as early as possible and prevent severe illness and further spread.

The preferred laboratory test for mpox is detection of viral DNA by polymerase chain reaction (PCR). The best diagnostic specimens are taken directly from the rash –skin, fluid or crusts – collected by vigorous swabbing. In the absence of skin lesions, testing can be done using swabs or the throat or anus. Testing blood is not recommended. Antibody detection methods may not be useful as they do not distinguish between different orthopoxviruses.

HIV testing should be offered to adults with mpox, and children as appropriate. Diagnostic tests for other conditions should be considered where feasible, for example, varicella zoster virus (VZV), syphilis and herpes.

Deferment of Maternity

The Irish Cancer Society has welcomed cabinet approval for a legislative amendment allowing women to defer maternity leave in cases of serious illness and paid tribute to campaigners who have fought for this change. The Maternity Protection (Amendment) and Miscellaneous Provision Bill will ensure that women undergoing treatment for cancer, or other serious illnesses can postpone their maternity leave for a year. The need for change was spearheaded by a group of women who went through cancer postpartum as part of the Irish Cancer Society’s ‘Leave Our Leave’ campaign.

Averil Power, CEO at the Irish Cancer Society, said, “Currently, women with cancer can’t defer their maternity leave until their treatment ends.

“This means that when their maternity leave runs out, working mothers have to return to work and never get back the vital bonding time they missed when they were sick. The Irish Cancer Society’s ‘Leave Our Leave’ campaign, led by women affected, has been highlighting the distressing impact this is having on women and their babies.

“Last year, Minister O’Gorman signalled he would change the law and we’re delighted that legislation is now moving forward. We also welcome the Minister’s commitment to fast tracking the legislation.

“It is essential it now passes through the Oireachtas as quickly as possible, so the change is made before the next general election. I’d like to thank the women and their families who have supported the campaign.

“By bravely sharing their stories, they have highlighted how awful it is to go through cancer while pregnant or with a young baby and how cruel it is to be unable to postpone your maternity leave until you are better. Thanks to them, when this change is implemented, other women will be spared that heartbreak.”

Focusing on Inclusive Health

The HEPA Europe (the European Network for the Promotion of Health-Enhancing Physical Activity) 2024 Conference, a major international event jointly organised by RCSI University of Medicine and Health Sciences and the World Health Organization (WHO) Europe, opened last month in RCSI.

The conference was focused on the theme “Optimising HealthEnhancing Physical Activity: The Importance of Inclusion” and brings together over 420 experts, researchers, and policymakers from 36 countries.

With 184 abstracts from leading researchers in the field of physical activity and an additional 55 covering policy and practice, the conference bridged the gap between research, policy, and practice in health-enhancing physical activity. This synergy is needed to drive transformative change in health policies and practices, thereby improving the health outcomes of people in Ireland and across Europe.

Professor Suzanne McDonough, Professor of Health and Rehabilitation and Head of the School of Physiotherapy at RCSI, highlighted the significance of this year’s theme. “Our goal at this conference is to explore innovative ways to engage underrepresented groups, including people with disabilities, in healthenhancing physical activity. With representatives from policy and practice at the same table we can create a more inclusive environment that promotes physical activity for all.”

The importance of this collaborative effort was echoed by

Professor Adrian Bauman, keynote speaker

Dr Anna Chalkley, Chair of HEPA Europe. “The HEPA Europe 2024 conference represents a crucial platform for advancing our shared vision of an active and healthy Europe. By focusing on inclusion, we are not only addressing the disparities in physical activity participation but also promoting health equity.”

RCSI’s contribution to the conference was substantial, with 13 abstracts from the Schools of Physiotherapy, Nursing and Midwifery, Population Health, and Medicine. The research presented covers a broad spectrum of topics, including health-enhancing physical activity in chronic disease, pregnancy, sporting populations, and university students. Additionally, innovative approaches such as digital and nature-based physical activities are being explored to enhance participation among diverse groups.

The regional Advisor for Nutrition, Physical Activity and Obesity from the WHO Regional Office for Europe, Dr Kremlin Wickramasinghe, underscored the significance of the conference. “WHO Europe is committed to

Public Consultation Report

working with partners like RCSI and HEPA Europe to ensure that health-enhancing physical activity is accessible to everyone, regardless of their background or circumstances. This conference is a testament to our collective dedication to improving public health through inclusive and evidence-based strategies”.

The conference has been jointly organised by RCSI’s Schools of Physiotherapy and Population Health. These schools collaborate closely in research and education, offering programmes that equip healthcare clinicians with the skills needed to conduct physical activity consultations across clinical populations.

Minister for Health, Stephen Donnelly T.D and Minister of State with responsibility for Public Health, Wellbeing and the National Drug Strategy, Colm Burke T.D. has published the findings from the Public Consultation on Further Regulation of Tobacco and Nicotine Inhaling Products. The consultation ran for six weeks from November 2023 to January 2024.

The consultation looked at potential additional measures to decrease the appeal of nicotine inhaling products to young people, further denormalise smoking, and improve public health.

15,821 responses were received in total, with 90% of members of the public who responded being current vapers. Other responses were received from organisations and individuals in the spheres of health, education, consumer

rights, retail, hospitality and the manufacture and distribution of nicotine inhaling products and tobacco products.

Findings showed strong support for all possible interventions from health organisations, healthcare workers, teachers and non-vapers, highlighting the need to protect children and the uncertainty about the longterm impact from vaping. There was majority support from all

respondents for some regulation of point-of-sale display and of the packaging and appearance of nicotine inhaling products. There were mixed views on other measures from vapers, the tobacco and vaping industries and retailers, particularly in relation to flavours. In particular, many vapers and industry said that these were important for adults using nicotine inhaling products to stop smoking.

Promoting Good Eye Health

Pharmacists play a significant role in promoting good eye health, acting as accessible healthcare professionals who can provide essential services, education, and guidance to the public.

The pharmacy team’s role in eye health is multifaceted, including key areas such as;

Educating Patients: Pharmacists can educate patients about the importance of regular eye exams, the use of protective eyewear, and the impact of lifestyle choices on eye health, such as smoking cessation and diet.

Counselling on Eye Health: They provide information on eye health and advice on digital eye strain. With increasing screen time, pharmacists can offer guidance on managing digital eye strain, including tips like the 20-20-20 rule (every 20 minutes, look at something 20 feet away for 20 seconds).

Reviewing Medications: Pharmacists review patients’ medications to ensure there are no side effects impacting vision or contraindications with eye health.

Advising on Eye Drops and Ointments: They assist in selecting appropriate over-the-counter (OTC) eye drops

and ointments, ensuring proper usage and understanding potential side effects.

Benefits of Omega-3 for Eye Health

Photoreceptor cells in the retina contain omega-3 fatty acids. Docosahexaenoic acid (DHA), a type of omega-3 fatty acid, is found in high concentrations in the retina. For good reason too, as it helps to maintain normal vision, the beneficial effect is obtained with a daily intake of 250mg of DHA.

The retina is a specialised part of the inner eye. It’s important because the retina’s lightsensitive cells, called photoreceptors, convert light into electric signals, which are sent via the optic nerve to the brain and become the images that we see. These cells have a high concentration of DHA.

The retina needs a constant supply of DHA to function normally. Because the body can

only make small amounts of DHA, diets rich in Omega 3 can help to maintain normal vision. Salmon, tuna and other cold-water fish can be a good source of Omega-3.

Why MacuShield is First Choice

Every MacuShield product contains LMZ3, a nutrient blend of all three macular carotenoids, providing:

• 10mg of lutein

• 10mg of meso-zeaxanthin

• 2mg of zeaxanthin.

The macular carotenoids in MacuShield are obtained from marigolds (Tagetes erecta), the petals are specifically used

Throughout adulthood our bodies need different things. That’s why the products in MacuShield’s range contain different nutrients, depending on a consumer’s nutritional needs. Which one’s right for each consumer?

MacuShield Original+: MacuShield Original+ is a one-a-day food supplement combining the three macular carotenoids as well as Vitamin B2, which helps maintain normal vision. For those who don’t like swallowing capsules, it also comes in a tasty bilberry flavour chewable tablet.

Macushield Gold: MacuShield Gold is a three-a-day soft gel capsule food supplement, combining a blend of LMZ3, with high dose vitamin C, vitamin E and copper, each help protect cells from oxidative stress, as well as zinc to help maintain normal vision.

MacuShield Original+ Omega 3: Original+ Omega 3 is MacuShield’s new one-a-day food supplement, combining all three macular carotenoids, as well as Vitamin B2 and 250mg of the Omega 3 fatty acid DHA, which each help to maintain normal vision. The beneficial effect on vision is obtained with a daily intake of 250mg of DHA. This product is also suitable for vegetarians and vegans, as the DHA is obtained from algal oil, a sustainable alternative to fish oil.

Our Original+ formula, now with Omega 3 Scientifically proven to help maintain normal vision*

Combines our LMZ3 (lutein 10mg, meso-zeaxanthin 10mg, zeaxanthin 2mg) with Omega 3 Contains 250mg DHA, the amount of Omega 3 required daily to have a beneficial effect on vision

A one-a-day capsule, made using algal oil suitable for vegans and vegetarians

*MacuShield Original+ Omega 3 contains Vitamin B2 and 250mg DHA, which each help to maintain normal vision. The beneficial effect is obtained with a daily intake of 250mg of DHA.

Views of the Visually Impaired

Views of visually impaired adults on the quality of care provided by community pharmacies in Ireland: A qualitative interview study

Written by Ellen Roche Ryan & Dr Harriet Bennett-Lenane, Lecturer in Clinical Pharmaceutics, School of Pharmacy, University College Cork

According to the 2022 Census, approximately 297,000 people in Ireland experience blindness or a Visual Impairment (VI). It is well documented that people with VI typically experience a higher incidence of negative health outcomes. Significantly, the World Health Organisation have attributed this in part to unfair conditions experienced within the health system.

As community pharmacists we are the health system’s first point of contact for many patients. As VI poses various challenges to individuals in how they obtain and take medications, more needs to be understood regarding how we, as pharmacists, can optimally assist these patients. Given the current landscape of expanding responsibilities within community pharmacy in Ireland, we in the School of Pharmacy, University College Cork, believed this was the right time to investigate visually impaired patient experiences of community pharmacy care in Ireland.

Aims and Methods

This work aimed to seek opinions of patients with VI, regarding the level of care provided by community pharmacies in Ireland, to explore their personal experiences and recommendations. Our work focused on adults over the age of 18, with a VI, i.e., reduction in visual acuity and/or visual field of any severity and duration. Vision Ireland assisted in recruiting

interviewees and eighteen interviews took place between October and December 2023.

Main Results

Interviewees highlighted how disability awareness amongst pharmacy staff should be improved and how previous interactions, involving staff members not identifying their VI, had led to misunderstandings. It was felt that in some instances staff were unaware and lacked confidence of how to best communicate with patients with VI. Patients reiterated their happiness to explain communication preferences if asked and stressed the importance of speaking directly to the patient rather than a fully sight representative who may accompany them.

‘They literally handed me a pen and went tick the ones that you use regularly, and I was like ‘ahh...’ So, I asked them ‘could you actually read them out’. So, just a bit more awareness maybe, awareness is huge thing.’

(Interviewee 2, Female)

“A tailored approach to community pharmacy care for this cohort can be achieved through minor adjustments to our usual practice”

Furthermore, interviewees emphasised the importance of not covering braille instructions on medication packaging which facilitates their identification of different products. Most reported that the braille instructions on their medicines have previously been covered by a dispensing label. The importance of consistent medicines packaging, such as keeping products in original containers was also highlighted.

‘You have the packet and then they’re put into the Ziplock bags. You can’t distinguish which is which, whereas if they’re in the box, you can say yeah, these are paracetamol.’

(Interviewee 3, Male)

Interviewees also provided insights into how the internal layouts of pharmacies could be adjusted to improve accessibility. Currently, depending on the layout of certain pharmacies, particularly in larger premises, locating the correct counter is often difficult. In smaller premises, navigating narrow aisles is sometimes a challenge, particularly with guide dogs. Poor lighting and presence of various physical obstacles, more prevalent around Christmas time, also causes problems.

‘Steps and narrow aisleways, or stuff in the aisleways, like boxes on the ground or the bargain basin at the end, those kinds of things give you bad access.’

(Interviewee 1, Male)

However, it was clear that there are lots of supportive measures currently being implemented by

pharmacy staff to support these patients. Examples of aids to help with medication management included blister packs, measured syringes, cutting tablets in half and placing medications in different sized packaging or separate containers. The potential to use mobile applications as assistive technologies were also highlighted. Applications highlighted included NaviLens, SeeingAI and Be My Eyes. Throughout our interviews the strong correlation between close patient-staff relationships and improved service was clear, with these patients usually preferring to attend one pharmacy. A small but significant recommendation was that staff should learn the names of patients with VI and to use them frequently to avoid unnecessary confusion.

‘If you do know the customer’s name, use it. There is nothing more embarrassing if they say ’what can I do for you?’ and you answer, and they’re talking to the person next to you.’

Conclusions

(Interviewee 8, Male)

Overall, our work suggests that a tailored approach to community pharmacy care for this cohort can be achieved through minor adjustments to our usual practice. Even as small as learning someone’s name! This study identified the importance of communication, collaboration and relationship building with these patients to achieve positive community pharmacy experiences and health outcomes for patients with VI across Ireland.

Ellen Roche Ryan Dr Harriet Bennett-Lenane

Clinically

ophthalmologist

Lead with Coaching - Empowering Sustainable Growth and Workforce Wellbeing

Pharmacy, should be a sanctuary where brilliant people thrive, yet too often it becomes a graveyard for faded hopes and dreams.

Have you tried everything you know? Have you noticed that no matter how hard you work, how many hours you put in, how many holidays and family events you sacrifice, it is never enough? Does it feel like a relentless treadmill, with no obvious or healthy escape?

It doesn’t have to be that way. When the way you are working isn’t working, a different approach is required. But what?

Over the first 25 years of this century, community pharmacies have faced unprecedented challenges and opportunities, and the pace of change continues to accelerate. Pharmacists, once seen primarily as dispensers of medications, are now expanding their roles, integrating clinical services, embracing digital health, and collaborating more closely with other healthcare providers. This shift opens up vast potential for growth and innovation, but it also brings significant pressures, including workforce burnout, regulatory challenges and resistance to change.

Coaching for Sustainable Growth

Leadership development, and especially developing leaders to lead with a coaching style of leadership, is an essential tool for navigating these complexities. By focusing on personal, professional and team growth, within a systems based philosophy, coaching empowers pharmacy leaders to foster a culture of continuous improvement, innovation, and sustainable growth and to thrive in the face of increasing complexity within their pharmacy businesses,

Written by Rachel Dungan, MPSI MCC ACTC

the healthcare system and the global context.

• Enhancing Leadership Capabilities: Pharmacists and their teams are stepping into increasingly diverse and demanding roles. No single person has the capability or capacity to manage it all. Therefore the most future ready leaders are those who have the capability to create the environment where leadership is developed within and across the entire team, enabling them to be more responsive as they navigate change. Coaching builds the confidence and skills necessary to lead effectively,

develop teams, communicating a clear vision, and aligning strategies with the evolving demands of healthcare.

• Driving Strategic Innovation: Community pharmacy is at the forefront of innovation, from tele-pharmacy to personalised medicine. Coaching equips leaders and their teams to embrace these innovations by fostering strategic thinking and adaptability. This growthmindset enables pharmacies to adopt cutting-edge technologies, explore new business models which create more value with less stress, creating sustainable initiatives.

• Fostering Workforce Wellbeing: Burnout is a critical issue in the pharmacy profession. Coaching addresses

this by connecting back to purpose, promoting resilience and wellbeing among leaders and their teams, leading to higher job satisfaction, reduced turnover, and a more sustainable workforce.

Overcoming

Barriers with Coaching

Despite the opportunities for growth, several barriers hinder progress in community pharmacies. Leadership development coaching plays a vital role in overcoming these obstacles.

• Navigating Regulatory and Reimbursement Challenges: Many expanded services are not fully supported by current regulations or reimbursement structures. Coaching helps leaders develop the strategic skills needed to optimise their

full scope of practice, advocate for change, navigate complex regulations, and explore additional funding models.

• Addressing Workforce Shortages: Workforce shortages and burnout make it difficult for pharmacies to capitalise on new opportunities. Coaching helps leaders create compelling environments that enhance employee wellbeing and foster and inspire teamwork, thereby building a more resilient workforce.

• Overcoming Resistance to Change: It requires energy to change. Resistance to change is therefore a common barrier, especially in professions and organisations where the workforce is burnt out and exhausted. Coaching helps leaders to create the conditions for change to happen, by creating clarity on the desired outcome, the conditions that are most likely to optimise that outcome and engaging teams in the transformation process towards aligned goals.

Case Study: Proactively Facing Challenges

Can you relate to community pharmacist Emma?

From early in the pandemic, Emma recognised that many of the old ways of working were not fit for purpose anymore. She saw that if she and her team continued with the same approach burnout and decline were inevitable. Instead of clinging to the past, Emma chose to invest in her vision for the future.

In the midst of the COVID crisis, Emma decided to embark on a journey of transformation. She began with leadership development coaching, starting with herself and then extending the opportunity to her team. Through coaching, Emma learned to prioritise her own mental, physical, and social wellbeing. She understood that she needed to be strong to support her team effectively.

With her coach’s guidance, Emma fostered a culture of curiosity and continuous learning within her pharmacy. She encouraged her team to embrace change as an opportunity rather than a threat. This mindset shift led to tangible results. Emma’s pharmacy not only started offering vaccination services but also expanded into private clinical services— something she would have never actively considered before. The response from patients was overwhelmingly positive, further energising the team.

Top Tips for Sustainable Growth and Workforce Wellbeing

1. Invest in Leadership Development: Develop yourself and your team members’ leadership skills through cross-professional, inter-industry leadership development training and internal strategic coaching days. If you are a team leader, regularly engage in leadership coaching yourself, so you role-model your own leadership growth and adapt your leadership style for maximum positive impact in the changing pharmacy landscape.

2. Prioritise Employee Wellbeing: Starting with yourself, prioritise and model self-care health care. Put your own oxygen mask on first and learn how to create the workplace culture where you foster a culture of resilience, support and care for each other to prevent burnout and enhance job satisfaction.

3. Embrace Innovation: Actively foster an open, growth-mindset, including keeping up-to-date with technological developments, leadership best practices and business models. Healthcare professionals that proactively seek to expand their perspectives and models of the world e.g. by developing the ability to partner with other leaders, healthcare professionals, patients and team members in innovative, thoughtprovoking ways, will outperform those who don’t adapt to emerging approaches to drive growth and improve patient care.

4. Choose Life: If the way you are working isn’t working, name it, face it, accept that reality and do something different! Ask for help! Face your fears! Embrace your genius! Get a coach! Changing is not easy but not changing sucks your soul.

Questions to Ask Your Team

1. How do you feel about the current direction and workplace culture of our pharmacy?

2. What challenges are you facing in your role, and what are your ideas about how can we address them together?

3. What are our shared goals and how can we better support each other to achieve them?

Questions to Ask Yourself

1. What am I doing that is helping and hindering my team members to grow, develop and shine in their role?

2. Am I showing up at my best, playing to my strengths and bringing out the best in myself and others?

3. How can I become the person I need to become in order to survive and thrive in tomorrow’s world?

Case Study: From Burnout to Brilliance

Sarah, a pharmacy manager, who had just come back from maternity leave, was overwhelmed by the demands of her role. She and her team were struggling with burnout, and the pharmacy had become stuck in a cycle of high turnover and low morale. After engaging in leadership coaching, Sarah learned to prioritise her own and her team’s wellbeing, foster a culture of collaboration, and lead with a compelling vision. As a result, she chose to stay in her role as supervising pharmacist, her pharmacy transformed into a thriving business with a motivated, engaged team. The connection with Purpose, Personal Wellbeing, and Professional Growth became stronger, leading to improved People Skills, Product and Service Innovation, and overall Pharmacy Prosperity.

Case Study: Stuck in a Relentless Loop of Firefighting

Can you relate to community pharmacist John?

John is exhausted. His pharmacy, once his pride and joy, now feels like a sinking ship. His team is stretched thin, morale is at an all-time low, and he hasn’t taken a holiday since before COVID. The pressures have only intensified as the demand for clinical services grows, yet John hesitates to change. He and his team are already at their breaking point, too overwhelmed to even consider taking on anything new. The pharmacy operates as it always has, with a singular focus on dispensing medications. But as the workload continues to increase relentlessly, so does the stress.

Despite the long hours and the relentless effort to keep things afloat, the situation worsens. Key staff are leaving, unable to cope with the burnout, and John finds himself trapped in a vicious cycle of firefighting. Every day, he battles with incessant medicine shortages, trying desperately to stay above water. The passion that once fuelled his career has faded, replaced by a crushing sense of hopelessness.

In a moment of desperation, John reaches out to inquire about coaching—not to find a way to save his pharmacy, but to find a way out. His partner has been blunt: the way he’s working isn’t sustainable, and they can no longer see a viable future in pharmacy. They know there has to be another way, but they have no idea where to begin.

Through coaching, John finally takes a breath. He gains clarity on what he needs to stop doing and identifies the skills he must develop to create a more compelling future. Both he and his partner join a leadership mental fitness coaching programme, and for the first time in years, they feel a spark of hope. They see a path forward—not just to survive in pharmacy, but to thrive. Inspired by this new perspective, John is now preparing to develop the coaching leadership skills needed to lead others through the challenges ahead.

72 Growth & Innovation

Emma also began integrating digital health technologies to streamline operations and enhance both patient and team experiences. Collaboration with other healthcare providers became a cornerstone of her pharmacy’s approach. The changes were profound: her team became more engaged, motivated, and excited about the future. The pharmacy began to grow, attracting new customers and retaining talented staff. Emma’s passion for pharmacy was reignited, and her business began to thrive despite the ongoing challenges.

Far from feeling overwhelmed, Emma and her team now feel well-positioned to seize new opportunities, such as those presented by the Expert Task Force.

The Power of Coaching: A Tale of Two Pharmacists

What made the difference between John and Emma? Both faced similar external pressures, but their internal responses were worlds apart. John’s story is a cautionary

tale of what happens when you cling to the status quo, pushing harder and longer in a desperate bid to make a failing system work. His reluctance to change, and focus on what wasn’t working led to a downward spiral of exhaustion and despair, highlighting the painful consequences of resisting change and neglecting personal and team wellbeing.

Emma, on the other hand, illustrates the transformative power of proactivity. By choosing to think strategically, act proactively, and seek support to lead with confidence, creativity, and compassion, Emma turned challenges into opportunities. Her focus towards wellbeing, innovation, and collaboration not only revitalised her pharmacy but also reignited her passion for the profession.

John’s eventual realisation that “the way we are working isn’t working” marked a turning point—an acknowledgment that continuing down the same path

would only lead to more suffering. His decision to stop, reflect, and seek new perspectives through coaching is what finally allowed him to see and start to create a hopeful path forward. Their stories demonstrate that the same thinking that created the problem will not solve it. But as soon as we recognise this and open ourselves up to new ideas, new strategies, and new ways of leading, hope—and success—are within reach.

Will you continue to cling to the status quo, or will you take the courageous step towards transformation?

Leadership in Pharmacy: A Conversation about Coaching and Change

Q: Why is the current state of community pharmacy unsustainable?

A: Too many community pharmacies are stuck in a cycle of burnout, high turnover, and declining morale. The focus on dispensing medications, coupled with the pressure of medicine shortages and regulatory challenges, leaves little room for innovation or personal wellbeing. This environment is exhausting and uninspiring, leading to negative workplace cultures where pharmacists feel trapped and unfulfilled.

Q: How can leadership coaching change this situation?

A: Partnering with a professional leadership coach helps pharmacy leaders shift their mindset, embrace change, and foster a positive, supportive work environment. By focusing on personal, professional and team growth, coaching empowers leaders and their teams to create a culture of learning, collaboration, and innovation. This not only improves job satisfaction but also drives business growth and sustainability.

Q: What are the key benefits of leading with coaching?

A: Leading with coaching can transform a pharmacy by improving team morale, reducing burnout, and enhancing service delivery. It helps leaders and their teams develop the skills needed to navigate challenges, inspire each other, and explore new opportunities. The result is a thriving pharmacy with a motivated, engaged workforce and a strong connection to its purpose.

Q: How does coaching impact the culture of a pharmacy?

A: Coaching fosters a coaching and learning culture, where continuous improvement, collaboration, and shared

responsibility are prioritised. This contrasts with a stagnant or negative workplace culture, where fear, resistance to change, and a lack of support dominate. A vibrant, positive culture leads to a more fulfilling work environment, better patient care, and a more sustainable business.

Q: What are the biggest challenges pharmacy leaders face today?

A: The biggest challenges include navigating regulatory and reimbursement barriers, addressing workforce shortages, and overcoming resistance to change. Many pharmacists also struggle with a lack of business and leadership skills, making it difficult to drive growth and innovation.

Q: How can leadership coaching help overcome these challenges?

A: Leading with coaching empowers pharmacy leaders with the additional mindset, tools and strategies needed to tackle these challenges head-on. By developing strong leadership capabilities, enhancing business acumen, and fostering resilience, leading with coaching enables leaders to co-create a sustainable, thriving pharmacy that can adapt to the evolving healthcare landscape.

Invitation to Pharmacy Leaders

If you recognise that the way you and your team(s) are working isn’t sustainable and are ready to invest in developing the leadership capabilities required to embrace current and future challenges, we invite you to explore our leadership coaching programs. Together, with your team we can create strategic coaching days for you and your team to

1. Create a compelling vision for you, your pharmacy and your team

2. Shape a workplace culture that attracts and retains brilliant people

3. Develop the coaching and conversational skillset that unlocks the brilliance of your people and the business

4. Put the infrastructure and resources in place to ethically scale and grow the business

Email Rachel@racheldungan.com for the dates of our upcoming open Lead With Coaching Programmes and request a brochure.

Rachel Dungan MPSI MCC ACTC

Known as ‘The Pharmacist Coach,’ Rachel is an awardwinning, Master Certified Coach (ICF-MCC-ACTC) to purposeful leaders & their teams.

New HSE Immunisation Programme

treatment in intensive care units.

This new programme will protect babies immediately after birth as it is being offered free of charge to all newborns in every maternity hospital in Ireland before they are discharged home. I would urge parents of all babies born in this period to take up the offer when the programme begins in September.

Her coaching clients come from a range of backgrounds, including pharmacy, healthcare, entrepreneurship and technology. She is Director of Education on ‘Lead With Coaching’ Programme, a sought-after, cross-industry leadership development programme for growth-oriented leaders, managers and business teams, committed to expanding their leadership skills to create and sustain thriving workplace cultures that unlock the potential of themselves, team members, teams and the business. https://racheldungan. coachesconsole.com/lead-withcoaching-programme

She is a seasoned Professional, Clinical & Business Leader, who has served in a leadership capacity in hospital, community and retail pharmacy over the last 30 years.

She lives in Lismore, Co Waterford, with her home team - her husband & three teenage children – a case study in team dynamics! She enjoy practicing yoga, walking by the Blackwater, cooking for friends & growing her own food & medicinal plants.

LinkedIn: https://www.linkedin. com/in/racheldungan/

A new HSE immunisation programme to protect new born babies against respiratory syncytial virus (RSV) is now available. Babies born between 1 September 2024 and 28 February 2025 will be offered a new monoclonal antibody immunisation, which is the best way to protect against RSV. RSV is a common virus that causes respiratory infections in young babies and the risk of severe infection is highest in the youngest infants, especially those born during the RSV season, according to the Director of the HSE National Health Protection Office, Dr Éamonn O’Moore. This is why we are offering the immunisation to those born between September 2024 and February 2025 which corresponds to the time of the year when RSV is circulating.

Dr O’Moore says, “Each winter in Ireland one in two newborn babies will get RSV and many will need medical care from their GP or the emergency department of a children’s hospital. Four out of a hundred newborn babies are hospitalised due to RSV, with some babies needing special

“The immunisation - nirsevimab - is strongly recommended by the HSE and the National Immunisation Advisory Committee (NIAC), for all infants born in Ireland and has been approved by the European Medicines Agency. Nirsevimab starts working as soon as the baby receives the injection and protects against RSV for 150 days, covering the very early period in a baby’s life when they are most vulnerable to serious RSV related illness.’’

As well as protecting young babies against serious illness, the RSV immunisation programme will help safeguard vital hospital paediatric services during the very busy winter months by limiting preventable admissions caused by RSV related illness. Based on evidence from a similar programme implemented in Spain, it is estimated that the infant RSV programme in Ireland will lead to the avoidance of up to 453 hospitalisations and up to 48 ICU admissions.

“The programme is initially being rolled out as a ‘pathfinder’ initiative which is designed to explore and establish innovative approaches to improving health outcomes within a community or population. Such programmes often serve as pilots or models that can be scaled up and replicated in other settings,” added Dr O’Moore.

Date for your Diary

The Irish College of Ophthalmologists Eye Care in Focus Conference 2024 takes place on Tuesday, 1st October at The Gibson Hotel, Dublin from 8am-4pm.

The 1-day clinical education meeting is organised by the College for the multi disciplinary team working across community and hospital care, providing an excellent forum for knowledge sharing amongst those involved in the delivery of eye care in Ireland.

Programme Overview

• Cataract - Challenging clinical situations in cataract diagnosis

• Paediatric OphthalmologyWhat to look out for at the first visit

• Making your Practice more Sustainable

• National Clinical Programme in Ophthalmology

• Update on Plans for a New School of Optometry at South East Technological University This year clinical talks will be focused on Paediatrics and Cataract. There will be a dedicated session on how to make eye care practice more

sustainable. Presenters include ophthalmologists Mr Tim Fulcher and Ms Lisa McAnena, Mater Hospital and Beaumont Hospital, Dr Margaret Morgan, Royal Victoria Eye and Ear Hospital and CHO7, Dr Ger Comer, University Hospital Galway and CHO2 (West), Dr Christine Bourke, Children’s Health Ireland and Dr Alison Green, University Hospital Waterford alongside allied health professional team colleagues, Ms Tania Constable, Clinical Optometrist CHO7 and President of Optometry Ireland, Ms Chriosa O’Connor, Clinical Optometrist, Mater Hospital, Dublin, Ms Louise Doyle, Theatre Nurse, University Hospital Waterford and Keith McCallion, Optometrist, Director; Specsavers Opticians and Audiologists, Athlone and Longford.

Ms Aoife Doyle, National Clinical Lead for Ophthalmology will provide an update on the latest programme developments and delegates will also hear from Ms Sarah Spain, Orthoptist, who has been recently appointed

the Health and Social Care Professions (HSCP) Orthoptist Lead for the Clinical Programme for Ophthalmology

Prof John Nolan, Founder and Director of the Nutrition Research Centre Ireland and Principal Investigator of the Macular Pigment Research Group, South East Technological University will discuss the findings of his Centre’s research into the role of nutrition in eye and brain health. Prof Nolan will also update delegates on the new school of optometry planned for the south east.

Chair of the upcoming meeting, Mr John Doris, President of the Irish College of Ophthalmologists, said,

“Now in its 3rd year, the annual Eye Care in Focus conference has been a very welcomed event for all involved in the delivery of eye care in Ireland. The meeting programme will be of interest to ophthalmologists and those in training, general practitioners, optometrists, orthoptists, ophthalmic nurses and technicians working in the hospital and community setting as an important forum for shared learning across the disciplines. We’re looking forward to another great event in October.”

Visit the ICO website www.eyedoctors.ie and follow us @eyedoctorsirl for programme and guest speaker updates!

Astellas Receives Positive CHMP Opinion for PADCEVTM (enfortumab

vedotin)

in combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of

Astellas Pharma recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of PADCEVTM (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.1

Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas

“Treatment options available to patients with unresectable or metastatic urothelial cancer are currently limited mainly to platinum-containing chemotherapy. The data underpinning the CHMP’s approval recommendation show that this combination could change how clinicians manage first-line treatment of

this disease. We are delighted that the CHMP recognized the potential for enfortumab vedotin in combination with pembrolizumab as first-line treatment for patients with unresectable or metastatic urothelial cancer.”

The positive CHMP opinion is based on data from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed enfortumab vedotin in combination with pembrolizumab significantly extends overall survival (OS) and progression-free survival (PFS) compared to platinum-containing chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). Treatment with the combination resulted in a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months (95% CI: 13.9-18.3) with chemotherapy, representing a 53% reduction in risk of death (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.380.58; P<0.00001). The median

Advanced Bladder Cancer

PFS of 12.5 months (95% CI: 10.4-16.6) with the combination compared to 6.3 months (95% CI: 6.2-6.5) with chemotherapy represents a 55% reduction in the risk of cancer progression or death (HR=0.45; 95% CI: (0.380.54); P<0.00001). During the EV-302 trial, approximately 30% of patients completed treatment with chemotherapy and then went on to receive maintenance therapy with avelumab, a PD-L1 inhibitor, which is reflective of current real world clinical practice.1 Results were presented at the 2023 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine.

The positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines in all 27 EU member states as well as Iceland, Liechtenstein and Norway.4

In December 2023, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin in

combination with pembrolizumab for the treatment of adult patients with la/mUC.5 In December 2023, the HSE reimbursed enfortumab vedotin monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have previously received a platinumcontaining chemotherapy and a programmed death receptor-1 (PD1) or programmed death-ligand 1 (PD-L1) inhibitor.6

Astellas has already reflected the impact from this result in its financial forecast for the current fiscal year ending March 31, 2025.

For more information, please see the press release “European Medicines Agency Validates Type II Variation Application for PADCEVTM (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer” issued on January 29, 2024.

References available on request

O N LY

TRIPLE

ACTIVE FORMULATION

Solpa Cold & Flu Multi Relief Max Powder for Oral Solution, Paracetamol 1000 mg, Guaifenesin 200 mg, Phenylephrine Hydrochloride 12.2 mg.

For the relief of symptoms of colds and flu and the pain and congestion of sinusitis, including aches and pains, headache, blocked nose and sore throat, chills, lowering of temperature, and to loosen stubborn mucus and provide relief from chesty coughs. Adults, the elderly and adolescents aged 16 years and over: One sachet every 4-6 hours as required to a maximum of 4 sachets (4 doses) in a 24-hour period. Do not give to children and adolescents under 16 years. Not to be continued for over 3 days without consulting a doctor. Contraindications: Hypersensitivity to any of the ingredients, severe hepatic impairment, hyperthyroidism, hypertension, diabetes, cardiovascular disease, those taking tricyclic anti-depressants or beta-blockers or other antihypertensive agents, patients who are taking or have taken monoamine oxidase inhibitors within the last two weeks or those currently receiving other sympathomimetics, phaeochromocytoma, closed angle glaucoma, and porphyria. Precautions: circulatory disorders, chronic alcoholism, urinary retention or prostatic hypertrophy, gilbert’s syndrome, concomitant treatment with flucloxacillin and medicinal products affecting hepatic function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia, glutathione deficiency, dehydration, chronic malnutrition, elderly, adults and adolescents weighing less than 50kg, may act as a cerebral stimulant. Use with paracetamol-containing products. Do not take with alcohol. Pregnancy and lactation: Not to be taken during pregnancy or whilst breast feeding without medical advice. Side effects: Thrombocytopenia, agranulocytosis, anaphylaxis, severe cutaneous hypersensitivity, bronchospasm, hepatic dysfunction, acute pancreatitis, angioedema, angle glaucoma. See SmPC for full list of side effects and further information. Product not subject to medical prescription. PA1186/021/003. MAH: Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland. Date of preparation: Feb 2023. SPC: https://www.medicines.ie/medicines/solpa-cold-flu-multi-relief-max-powder-for-oral-solution-35312/spc#tabs

The Intersection of Conduct and Care

Written by Stephen A McMahon Co-Founder Irish Patients Association

The Irish Patients Association, founded as Ireland’s first independent, cross-disease patient advocacy group, operates on a non-political basis with a focus on patient safety and rights protection. Since 2013, the association has been reliant on voluntary work without public funding from the Health Service Executive (HSE) or paid staff.

Patient safety in Ireland's healthcare system remains fraught with issues, including problems within Emergency Departments, prolonged waiting times for consultant appointments and surgeries, restricted access to GP panels in various regions, and persistent funding overruns. While some issues are due to resource limitations, others require cultural and operational changes rather than just financial input. A critical area for improvement is the corporate conduct towards patients, which often lacks the expected standards of respect and professionalism. Corporate conduct encompasses how healthcare organizations interact with patients, manage medical errors, allocate resources, and ensure transparency and responsiveness in addressing patient concerns and complaints.

Financial Concerns Amid Workforce Issues

The HSE has secured a ¤1.5 billion supplemental budget to manage this year's overspending, aiming to mitigate any adverse impacts on patients. However, there is concern regarding the HSE’s workforce cap of 130,000 by the end of 2024, which is significantly lower than the current annual turnover rate of 145,985 WTE or 163,792 personnel. Clarity on this cap is necessary to ensure adequate staffing levels to meet patient needs. Furthermore, the unresolved Internal Audit investigation into the ¤19 million intended for children's spinal operations raises additional concerns. The HSE's approach needs to transition from a reactive to a proactive stance, identifying and addressing issues before they escalate.

Patient User Experience

The HSE own Patient Experience Survey conducted by HIQA for 2022 reports high satisfaction levels however Patients were also less positive about the availability of emotional support, time to discuss care and treatment with a Doctor, information on how to manage a condition after leaving

hospital, and opportunities for family members to talk to a Doctor.

22% of participants said that they did not find a member of staff to talk to about their worries and fears.

On the other hand, benchmarking against other industries presents a different insight.

In May 2024, the strategic communications firm, The Reputations Agency, published its Ireland RepTrak® 2024 report which studies public perceptions of 100 of the largest, most important and most familiar organisations in Ireland. This year the HSE, with an annual budget of ¤23Billion, was positioned in the weak reputation tier and ranked in 95th place. The challenge for the HSE is to understand why they have performed in this way compared to for example the Mater Private Network and the Blackrock Healthcare Group who ranked in 7th and 10th position respectively in the same study.

[See table 3.]

Patient Experiences Reflect Systemic Issues

Several patient experiences in 2024 highlight systemic failures requiring urgent attention. Issues

include poor communication and unprofessional behavior from healthcare providers. For instance, patients have reported being told that there are "sicker people" who need attention or that management prioritizes other issues over their concerns, which is disrespectful and unprofessional.

Examples of Problematic Conduct Include:

Handling Phone Calls: One patient’s calls to Hospital A were redirected to Hospital B, resulting in a curt response and a disconnected line when attempting to proceed with a transfer request.

Mixed Wards: An elderly patient was repeatedly placed in mixed wards against her will and preferences, allegedly due to discriminatory practices favoring certain patients for private or female-only wards.

Long Waits and Communication: The extended wait for ADHD assessments has left patients in limbo for over a year without clear timelines, significantly impacting their well-being.

Surgical and Equipment Failures: Last-minute cancellations of surgeries due to overlooked health issues and denial of necessary

Figure 1: Half Year Review - Health Systems Performance January - June 2024 vs Year End 2023

medical equipment for home discharge demonstrate a lack of thoroughness and disregard for patient needs.

Challenges in Care Transfer and Delayed Diagnoses

Patients also face difficulties in transferring care closer to home. One patient, who had traveled extensively for 20 years, struggled to switch to a more conveniently located hospital due to new waiting lists, despite serious conditions. This highlights systemic issues in patient management and accessibility. Additionally, delayed diagnoses and dismissive responses to patient complaints further tarnish the healthcare experience. For instance, a patient's injury was ignored for months, and when accountability was sought, the response from the Doctor was irritated and dismissive.

"Change and Reform in our healthcare systems should not be preceded by preventable funerals and injury to patients"

Waiting Lists and Cancellations

Waiting lists for operations are growing, with adult lists increasing by 4.4% by Q2 2024 compared to the previous year. The number of patients waiting 6-12 months, 12-18 months, and over 18 months has also risen. For children aged 0-15 years,

waiting lists grew by 28,000 in the first 16 weeks of 2024, despite a minor overall drop. Misallocation of ¤19 million intended to reduce waiting times and improve spinal and orthopaedic services for children underscores the need for accountability and effective fund management. The Department of Health has requested an audit of children's orthopaedic care to examine the use of this funding.

Cancelled Operations and Overcrowded Emergency Departments

Overcrowding in emergency departments led to 50,000 operation cancellations in the first quarter of 2024, which could have reduced the waiting list by 55%. This overcrowding significantly impacts patient safety and highlights issues in capacity and processing efficiency within the HSE. The HSE should adopt best practices, including detailed reporting on rescheduled operations post-cancellation, similar to the NHS in England.

Disparities in Consultant Waiting Times

As of mid-2024, 20.5% of the population without private health insurance is waiting for their first consultation with a hospital

consultant, whereas those with private insurance face minimal waiting times. This disparity raises concerns about the effectiveness of Sláintecare, especially if unsafe waiting times are not reduced significantly. While there has been a 5% decrease in patients waiting over 18 months, the number waiting between 12 and 18 months has surged by 17.7%. Alarmingly, children are now experiencing longer waits than adults, with 16.1% of children waiting over 12 months by June 2024 compared to 14.2% at the end of the previous year.

Conclusion: The Importance of Conduct

The Importance of ConductThe Reputations Agency Ireland RepTrak® 2024 report highlights that conduct is as crucial as products and services in building and protecting reputations. Healthcare organisations must prioritise fairness, transparency, and ethical behaviour to uphold patient rights and improve care quality. A commitment to respectful and compassionate interactions with patients and their carers is essential. This commitment is vital in a financially constrained yet hungry industry and starts with genuinely listening to patients and their families.

Figure 2: Disparities in Consultant Waiting Times

Figure 3: Table 3 HSE scores over the past seven years

Health Provider Portal Update

The Evolution and Impact of Ireland’s Health Provider Portal

The Health Provider Portal (HPP), built in-house by the A2I-HIDs development team, is a suite of four web-based applications:

• HSE PharmaVax

• HSE GPVax

• HSE CommunityVax

• HSE Vaccination History Search

The first of these applications, HSE PharmaVax, went live on 14 June 2021. Developed initially to support COVID-19 vaccine administration across Community Pharmacies, HSE PharmaVax is now available to over 1600 registered Pharmacies in Ireland.

In late August 2021, the user base was expanded with the creation of the HSE GPVax application

to enable GPs, who do not have accredited practice management systems, to electronically record the COVID-19 vaccinations administered in their practices. The Vaccination History Search facility was also developed at this time to allow users to confirm the vaccination history of a client prior to vaccination.

Both HSE PharmaVax and HSE GPVax are integrated with the national vaccination system, COVAX. This integration, supported by the Individual Health Identifier, ensures that all citizens’ vaccination records can be managed centrally regardless of where the vaccination was administered. Reimbursement claims relating to the administration of vaccinations

WEBINAR Transforming Clinical Pharmacy Processes Using MEG

are also communicated from HSE PharmaVax and HSE GPVax to the Primary Care Reimbursement Service (PCRS) to enable payments to be processed to participating Pharmacies and GPs.

Progression of the Health Provider Portal

In 2022, HSE PharmaVax and HSE GPVax functionality was extended to enable users to record influenza and pneumococcal vaccinations.

In 2023, the corrections facility for vaccinations was introduced, along with the launch of the HSE CommunityVax application. The CommunityVax application provides a vaccination event recording service for community organisations, care homes and private hospitals that administer influenza vaccinations, as part of the yearly seasonal flu campaign. The HPP Admin Portal also went live in 2023. This provides the HPP Support Team with key system admin functionalities to manage user onboarding and resolve user issues effectively.

The Year Ahead

This year the HPP team has already delivered application enhancements to facilitate the Spring COVID-19 Vaccination Programme as well as expanding the HPP System Admin functionality.

By mid-year, reimbursement claims to PCRS for Pharmacies and GPs enrolled in the vaccination programme, will be

Wednesday 2nd October 12:30 pm

progressed to near real-time automatic transfer via Healthlink HL7 messaging integration.

Work is ongoing to make our applications as user-friendly as possible with improvements planned for the reporting features and client registration process. Changes will also be implemented to cater for the 2024/2025 influenza campaign.

Conclusion

As we approach the 3rd anniversary of the inception of the Health Provider Portal, it is humbling to reflect that our in-house developed applications have now recorded nearly 2.5 million vaccinations.

Thanks to everyone involved in the design, implementation and ongoing support of this national public health solution, in particular the Technology and Transformation A2i-HIDs team who led this development, in close co-operation with our Technology and Transformation and clinical/ service colleagues (e.g. Covax and IIS teams, National Immunisation Office, Primary Care, Pharmacy and GP representatives, PCRS, Health Protection Surveillance Centre and HSE Live).

The future truly is bright for HPP. A2i-HIDs look forward to expanding the platform’s capability further to host new services as and when required.

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HEAR FROM EPILEPSY EXPERTS THIS SEPTEMBER!

September will be a busy month for the epilepsy community in Ireland, with two major events set to take place at the Gibson Hotel, Dublin!

First, the Irish Epilepsy League (IEL) will be hosting their annual Expert Day on Friday September 20th. The Irish Epilepsy League

are the Irish chapter of the International League Against Epilepsy. Their membership is made up of epilepsy healthcare professionals, scientists and researchers working in or investigating epilepsy in Ireland.

The Expert Day is an annual event organised by the IEL, specifically targeted at healthcare professionals and researchers working in epilepsy, but the event is also open to all healthcare professionals who may want to learn more about the condition and hear from experts working within the field of epilepsy.

The full agenda for the IELs Expert Day is as follows:

• 09.00 - Opening remarks and ILAE update - Dr. Peter Widdess-Walsh, President IEL

• 09.10 - Update from Epilepsy Ireland - Peter Murphy, CEO, Epilepsy Ireland

• 09.20 - Epilepsy nursing update – TBA

• 09.30 - John Kirker lecture

- The first epileptic seizure: Prof Tony Marson, The Walton Centre NHS Foundation Trust

• 10.30 - Break – tea/coffee and pastries

• 10.50 - Paediatric epilepsy surgery update: Dr. Sophia Varadkar, Great Ormond Street London

• 11.45 - How to order genetic tests for epilepsy: Prof Norman Delanty, Beaumont Hospital

• 12.30 - Lunch

• 13.30 - John Lynch Memorial Lecture - A mirror on social attitude: how epilepsy is depicted in film and literatureProf. Simon Shorvon, UCL/ Queen Square

• 14.30 - Debate – Folic acid 5mg (high dose) should be given to all women of childbearing age; For: Dr.Tudor Munteanu, Our Lady’s Hospital Drogheda; Against: Dr. Elisabeth Doran, St. James Hospital

• 15.30 - Prizewinner platform presentations – Chair Dr. Cristina Reschke, RCSI

• 16.00 - Concluding remarks –Dr. Peter Widdess-Walsh

If you are interested in attending the Irish Epilepsy League’s Expert Day, you can do so by registering via Eventbrite. The cost of attending is ¤20 for nonconsultant and ¤50 for consultants. Registration closes on the 12th of September. The link to the registration page is below or scan the QR code alongside this article!

https://bit.ly/IELED24

Following the conclusion of the Irish Epilepsy League Expert Day, Epilepsy Ireland will be hosting their National Conference at the Gibson the following day on Saturday September 21st. Epilepsy Ireland are the national organisation representing people with epilepsy and their families and are the Irish chapter of the International Bureau for Epilepsy.

While the Irish Epilepsy League’s Expert Day is targeted solely at Health Care Professionals, Epilepsy Ireland’s conference is patient-focused and sees people with epilepsy and their families from across Ireland attending, aiming to learn more about clinical developments and research in epilepsy. The conference also acts as an opportunity for people with epilepsy to meet with others in a similar situation to themselves. It is also open to allied Health Care Professionals, those working in education or any interested professional.

The full agenda for the conference is as follows:

• 9:00 – 10:00: Registration

• 10:00 – 10:05: Welcome and official opening

• 10:05 – 10:45: Dr Sophia Varadkar – Developments in diagnosis and treatment of complex childhood epilepsies

• 10:45 – 11:20: Professor Tony Marson – The First Epileptic Seizure

• 11:20 – 11:35: Questions and Answers for first two speakers

• 11:35 – 11:50 – Movement Break

• 11:50 – 12:30 - Dr Cristina Ruedell Reschke, Royal College of Surgeons in Ireland –Circadian Rhythms and epilepsy and sleep hygiene

• 12:30 – 1:00 – Epilepsy Ireland Updates and Volunteer of the Year awards presentation

• 1:00 – 2:15 - Lunch

• 2:15 – 2:50 – Registered Advanced Nurse Practitioner in Epilepsy, Sinéad Murphy –Women with epilepsy, the need to knows!

• 2:50 – 3:25 – Professor David Henshall, FutureNeuro –Epilepsy in dogs as a way to trial a new gene therapy.

• 3:25 – 4:00 – Dr Aoife Morrin, Dublin City University – AI, seizure scents and dogs!

• 4:00 – 5:00 – Epilepsy Community Meet-Up!

If you are interested in attending Epilepsy Ireland’s National Conference, tickets are available at the cost of ¤45 (including a two-course lunch) and can be purchased on Epilepsy Ireland’s website Epilepsy Ireland National Conference or by scanning on the QR code alongside this article.

Commenting on the busy September for the epilepsy community in Ireland, Epilepsy Ireland Advocacy & Communications Manager Paddy McGeoghegan said, “This year is the first year where we have our National Conference directly after the Irish Epilepsy League Conference – and it has allowed us to collaborate with our colleagues in the IEL to have international speakers attend both – seen by the fact Prof Tony Marson and Dr. Sophia Varadkar are speaking at both the patient and professional conferences. Hopefully this will be something that we will see replicated in the years ahead!

“We’re really looking forward to both conferences and would encourage HCPs with an interest in epilepsy to come to either or both to hear from experts working in the field! We hope to see you there!”

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80 Clinical Profiles

CORMICA‘S LABORATORY, MET ACHIEVES FIRST-TIME FDA INSPECTION SUCCESS

Cormica, as a global leader in comprehensive microbiological, analytical and physical testing services, upholds a commitment to quality across all its world renown laboratories. Our accreditations include Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), ISO 17025, and recognitions from leading regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA), and the United Kingdom Accreditation Service (UKAS). These certifications validate our dedication to excellence, enabling us to support clients in launching and releasing their products safely and rapidly worldwide.

MET (Medical Engineering Technologies Ltd), a Cormica laboratory, is dedicated to delivering world-class Combination Device, Medical Device and Pharmaceutical testing services. MET’s capabilities include performance, verification, validation, ageing, transit, packaging testing and analytical chemistry with a keen interest in extractables and leachables. By upholding the highest standards of quality and safety, we ensure that products meet rigorous safety and efficacy standards, maintaining their integrity from development through to market release. We are excited to announce that MET, has successfully passed its first FDA inspection. The inspection, which took place in April, focused on batch release testing after MET was named on a client’s submission. The result of this rigorous examination was NAI (No Actions Indicated), a significant achievement for our team.

“Passing our first FDA inspection with no actions indicated is a testament to the hard work and dedication of our team.

We have worked tirelessly to adhere to GMP principles, and this achievement validates our commitment to quality and excellence,” said Naomi Allkins, Quality Assurance Manager.

The positive outcomes from both the FDA inspection and the UKAS audit underscore MET’s position as a trusted and reliable partner in the field of pharmaceutical and medical device testing. These achievements demonstrate our capability to meet and exceed regulatory standards, providing our clients with the confidence that their products are tested with the utmost precision and care.

“This significant achievement by MET highlights the strength and commitment of our entire organisation to quality and regulatory compliance. It reinforces our mission to improve patients’ lives by providing comprehensive testing services that enable our clients to launch and release their products safely and rapidly,” said Mark Hammond, CEO of Cormica.

SARCLISA INDUCTION TREATMENT DEMONSTRATED SIGNIFICANTLY IMPROVED PROGRESSION-FREE SURVIVAL IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA ELIGIBLE FOR TRANSPLANT

New results from the two-part, double-randomized, German-

speaking Myeloma Multicenter Group (GMMG)-HD7 phase 3 study shows that Sarclisa (isatuximab) in combination with lenalidomide, bortezomib, and dexamethasone (RVd) during induction therapy in transplant-eligible, newly diagnosed multiple myeloma (NDMM) significantly prolonged progression-free survival (PFS) from first randomization, resulting in a statistically significant and clinically meaningful reduction in disease progression or death, compared to RVd induction regardless of the maintenance regimen. Full results will be submitted for presentation at a forthcoming medical meeting.

Hartmut Goldschmidt, MD, President of GMMG, Professor of Medicine at the Heidelberg University Hospital (UKHD), Germany and principal investigator of the study says, “Successful induction therapy is one of the most critical components to reduce the relapse or recurrence risk in patients with newly diagnosed multiple myeloma. While we observed this investigational combination showed improved minimal residual disease negativity rates in the bone marrow, indicating potentially deeper responses after induction, further follow-up was needed to better understand how this translated to long-term outcomes. These data provide evidence that the Isa-RVd regimen potentially improves progressionfree survival in the frontline, transplant-eligible population and supports the potential of this quadruplet to become a new standard-of-care induction regimen in this treatment setting.”

GMMG-HD7 is one of six phase 3 studies to report positive results for Sarclisa in patients with multiple myeloma, which includes four positive readouts of a Sarclisabased quadruplet in the frontline setting. The most recent included results from the IMROZ phase 3 study evaluating the investigational use of Sarclisa with VRd versus VRd for patients with transplantineligible NDMM, demonstrating a statistically significant and clinically meaningful improvement in PFS and a higher proportion of patients with minimal residual disease (MRD) negativity.

In December 2021, Sanofi and GMMG shared the results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients. The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. The use of Sarclisa in combination

with RVd is investigational and has not been evaluated by any regulatory authority.

While considered a rare disease, MM is the second most common hematologic malignancy,1 with more than 180,000 new diagnoses of MM worldwide yearly.2 Despite available treatments, MM remains an incurable malignancy in most patients with an estimated 61% five-year survival rate for newly diagnosed patients.3 Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.

GILEAD’S TWICEYEARLY LENACAPAVIR DEMONSTRATED 100% EFFICACY AND SUPERIORITY TO DAILY TRUVADA® FOR HIV

PREVENTION

Gilead Sciences, Inc. (Nasdaq: GILD) has announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women.

PURPOSE 1 met its key efficacy endpoints of superiority of twiceyearly lenacapavir to once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV). Based on these results, the independent Data Monitoring Committee (DMC) recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.

“With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We look forward to additional results from the ongoing PURPOSE clinical program and continuing toward our goal of helping to end the HIV epidemic for everyone, everywhere.”

These are the first data generated from Gilead’s landmark PURPOSE program, which is the most comprehensive and diverse HIV prevention trial program ever conducted. The PURPOSE program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity.

Mark Hammond, CEO, Cormica

Topline PURPOSE 1 data

PURPOSE 1, a Phase 3, doubleblind, randomized study, is evaluating the safety and efficacy of twice-yearly, subcutaneous lenacapavir for pre-exposure prophylaxis (PrEP) and oncedaily oral Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF) in more than 5,300 cisgender women and adolescent girls aged 16-25 across 25 sites in South Africa and three sites in Uganda. The drugs are being tested in parallel, with one group receiving twice-yearly lenacapavir and one group taking once-daily oral Descovy. Additionally, a third group was assigned once-daily oral Truvada. Study participants were randomized in a 2:2:1 ratio to lenacapavir, Descovy and Truvada, respectively. Because effective PrEP options already exist, there is broad consensus in the PrEP field that a placebo group would be unethical; thus, the trial used bHIV as the primary comparator and Truvada as a secondary comparator.

There were 0 incident cases of HIV infection among 2,134 women in the lenacapavir group (incidence 0.00 per 100 person-years). There were 16 incident cases among 1,068 women in the Truvada group (incidence 1.69 per 100 personyears). The results demonstrated superiority of twice-yearly lenacapavir over bHIV (primary endpoint, incidence 2.41 per 100 person-years) and superiority of twice-yearly lenacapavir over once-daily Truvada (secondary endpoint), with p<0.0001 for both endpoints. In the trial, lenacapavir was generally well-tolerated and no significant or new safety concerns were identified.

HIV incidence in the Descovy group was numerically similar (39 incident cases among 2,136 women, incidence 2.02 per 100 person-years) to that in the Truvada group and was not statistically superior to bHIV. Previous clinical trials among cisgender women have commonly found challenges with adherence to daily oral pills for PrEP, and adherence analyses for Descovy and Truvada from PURPOSE 1 are ongoing. In the trial, both Descovy and Truvada were generally well-tolerated and no new safety concerns were identified.

More detailed data from PURPOSE 1 will be presented at a future conference.

“Twice-yearly lenacapavir for PrEP, if approved, could provide a critical new choice for HIV prevention that fits into the lives of many people who could benefit from PrEP around the world—especially cisgender women,” said Linda-Gail

Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, and past President of the International AIDS Society. “While we know traditional HIV prevention options are highly effective when taken as prescribed, twiceyearly lenacapavir for PrEP could help address the stigma and discrimination some people may face when taking or storing oral PrEP pills, as well as potentially help increase PrEP adherence and persistence given its twice-yearly dosing schedule.”

The use of lenacapavir and the use of Descovy for the prevention of HIV in cisgender women are investigational and have not been determined to be safe or efficacious and are not approved anywhere globally.

ADULT PATIENTS IN IRELAND WITH ADVANCED NONSMALL LUNG CELL CANCER WITH METEX14 SKIPPING ALTERATIONS TO BENEFIT FROM ACCESS TO TREATMENT AS HSE REIMBURSES MERCK’S TEPMETKO® (TEPOTINIB) AS ORAL MET INHIBITOR SECONDLINE TREATMENT OPTION

Merck, a leading science and technology company, has today announced that the HSE has approved TEPMETKO® (tepotinib) for reimbursement in Ireland, for the second-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.

Tepotinib is the first and only oral MET inhibitor to be reimbursed in Ireland for the second-line treatment of adult patients with advanced NSCLC harbouring METex14 skipping alterations, and was previously only available for use on the NHS in England, Wales, Scotland and Northern Ireland.

Roisin Molloy, Managing Director of Merck Healthcare in Ireland, said, “This is an important step forward for targeted treatments in Ireland and it is fantastic news that the HSE has reimbursed tepotinib. There are a myriad of lung cancer types and we know that patients with METex14 skipping mutations suffer from poorer survival rates. Cancer treatments are thankfully evolving to personalise and target these specific variations. Every new reimbursement for a targeted treatment will be a game-changer for certain sets of patients who previously felt less hope than others with existing treatment options.”

Dr Stuart Hill, Medical Director of Merck Healthcare UK and Ireland,

said, “We know from working with healthcare professionals in oncology for many years that this particular variation of lung cancer brings a whole host of challenges and uncertainties for patients. It is brilliant that research is diversifying to start to target the wide spectrum of aggressive lung cancers. With tepotinib, a crucial next step will be ensuring that when patients initially present with lung cancer symptoms, they are able to easily access genomic testing to find out if this treatment might benefit them.”

Professor Stephen Finn, Consultant Pathologist, said, “Nonsmall cell lung cancer is a difficult disease to treat, but those who have METex14 skipping mutations sadly suffer from lower chances of progression-free survival than others. It is therefore very welcome news to have tepotinib made newly available to treat these patients in the second line and provide a targeted therapy. Studies have shown that it has clear benefits for eligible patients who are facing the challenges posed by this aggressive type of lung cancer. With the various mutations that lung cancer patients can develop, using targeted treatment and developing our genomics offer will be an important step forward for improving our personalised treatment offer to cancer patients in Ireland.”

NSCLCs with MET alterations are generally associated with poorer clinical prognosis compared to NSCLCs without MET alterations, with a lower median overall survival observed. The presence of these genetic alterations has been recognised as an important therapeutic target for personalised treatment, which can be identified via a tissue and/or blood sample. Targeted treatments, like tepotinib, require genomic testing to determine which patients are eligible. To enable advanced genomic testing, in 2022 HSE launched the National Strategy for Accelerating Genetic and Genomic Medicine in Ireland. The model will allow the HSE to develop a genomics service that improves health outcomes, reduces cost of care and fuels scientific innovation and discovery.

NEW HSE GUIDELINE TO SUPPORT PEOPLE DIAGNOSED WITH SKIN CANCER

The guideline will help provide information for treatment planning for people with melanoma. It will also help catch any recurrence or relapse early, leading to earlier treatments and interventions. It was developed in consultation with oncology patients, doctors, nurses and researchers. It aims to improve the quality of clinical care for patients and improve patient experience

Melanoma cancer patients and members of the Guideline Development Group, Kay Curtin, and Miriam Staunton said: “It was great to be involved in the process of creating the guidelines we felt the patient voice was heard. Melanoma Cancer guidelines are essential as they give patients an ability to advocate for themselves and help ensure consistency across Irelands cancer centres.”

Benefits to patients include:

• Provides information for treatment planning

• Catch a recurrence/ relapse early

• Reassurance that you are being monitored based on the best current evidence

Dr Sinéad Field, Consultant Dermatologist and Chair the clinical guideline development group, said: “Melanoma is on the increase in Ireland and while it is more common in people over 50, you can get it at any age. The new National Clinical Guideline for Radiological Staging and Surveillance of Patients with Cutaneous Melanoma will support people who are undergoing or have had treatment. Staging scans help to determine if a patient’s cancer has spread or is likely to spread to other parts of the body, or recur. This knowledge is useful as it provides an opportunity to optimise the patient’s treatment plan. Surveillance of patients after they have finished their treatment is to check for a recurrence or relapse of their cancer. This is useful as it provides an early opportunity for treatment.”

Dr Eve O’Toole, Head of Evidence and Quality Hub in the NCCP, said: “The purpose of the guideline is to provide evidence-based recommendations on the staging and surveillance of patients with cutaneous melanoma through the integration of the best research evidence with clinical expertise, patient values and experiences. Knowing what is happening now and what will be happening next can provide reassurance to patients that an optimum plan for them is in place. The guideline describes what tests patients should have and for how long surveillance should continue.”

82 Clinical Profiles

CLONMEL HEALTHCARE LAUNCH UZPRUVO® (USTEKINUMAB) – THE FIRST APPROVED USTEKINUMAB BIOSIMILAR IN IRELAND

Clonmel Healthcare are delighted to announce the introduction of Uzpruvo®, the new Ustekinumab biosimilar. Uzpruvo® will be marketed from July 22nd 2024, upon expiry of patent protection of the active ingredient of the reference biological medicine.

Uzpruvo® 45mg and 90mg solution for injection in pre-filled syringe are indicated for the treatment of Plaque Psoriasis, Paediatric Plaque Psoriasis, Psoriatic Arthritis and Crohn’s Disease1. Uzpruvo® is currently not approved for the treatment of ulcerative colitis indication (since the originator still has exclusivity for this indication).

Uzpruvo® offers patients a wide variety of benefits:

• European manufacturing1 and supply chain*

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

• Patient-friendly PFS: Easy handling, thinner needle+, latexfree++1,3

• Cost-effective option enabling improved access to ustekinumab treatment

Donagh O’Leary, General Manager said “Clonmel Healthcare

UZPRUVO 45 & 90 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

continues to grow and strengthen its portfolio of biosimilar medicines, which now spans several therapeutic areas including rheumatology, gastroenterology dermatology and oncology. We remain steadfastly committed to bringing a comprehensive range of biosimilar medicines to the market, thereby increasing access for patients, physicians and pharmacists to affordable medicines and treatments. We are delighted to contribute to the ongoing savings to the Irish healthcare system and supporting patient needs”.

*Supply chain is constantly being optimised and manufacturing location is subject to change.

**Stelara®. + 29 v 27-guage needle of the reference product, Stelara® ++ Plunger stopper made of bromobutyl rubber.

1 Uzpruvo® SmPC (Feb. 2024).

2 Feldman SR et al. Expert Opin Biol Ther. 2023;23(3);253-60. DOI: 10. 1080/14712598.2023.2235263;

3 Stelara® PI (Aug. 2022).

APC MICROBIOME IRELAND WELCOMES DR. SEBASTIAN SCHMIDT AS A NEW PRINCIPAL INVESTIGATOR

APC Microbiome Ireland (APC), a world-leading SFI Research Centre based at University College Cork (UCC), is proud to announce the appointment of Dr. Sebastian Schmidt, an outstanding computational biologist with a global reputation for pioneering advancements in microbiome data analysis, as a new Principal Investigator.

Previously based in the prestigious European Molecular Biology Laboratory (EMBL) in Heidelberg, Dr. Schmidt brings to APC an exceptional background in computational biology, focusing on the development of cuttingedge tools to analyse complex microbiome data. His innovative work has already made significant impacts on the field, including contributions to two seminal papers recently published in the leading international scientific journals Cell and Nature. As part of the UCC Futures Food, Microbiome & Health recruitment drive, Dr. Schmidt will also serve as a lecturer in microbiome and health affiliated with the UCC School of Medicine.

With nearly a decade of experience in microbiome research, Dr. Schmidt has explored fundamental questions of microbial ecology and evolution, while also engaging in applied work, such as discovering predictive microbiome signatures of diseases. His expertise in integrating large datasets to address new challenges in microbiome science has led to the development of several influential computational tools and resources.

Reflecting on his appointment, Dr. Schmidt stated, “APC and UCC have one of the longest and most distinguished histories in modern microbiome research. I am thrilled to join such a highly stimulating environment, surrounded by worldleading researchers in the field. I look forward to building a team here and working on fascinating research questions relevant to the global challenges of our time.”

A Future of Cutting-Edge Research

Dr. Schmidt’s appointment signals high ambition on the part of the APC as it continues to strengthen

its position as a global leader in microbiome research. His focus on developing cutting-edge computational tools and resources that push the boundaries of microbiome science will undoubtedly play a crucial role in advancing the APC’s research and strategic goals.

Welcoming Dr. Schmidt, APC Director Prof. Paul Ross, noted that “Dr. Schmidt’s expertise in computational biology, particularly in large-scale data analysis and tool development will hugely contribute to our capacity for microbiome research. We are excited to see the innovations and breakthroughs that will emerge from his work here at APC.”

Dr. Schmidt will initially focus his research at APC on the intricate interactions between diet and the gut microbiome. He aims to develop computational models that predict how dietary changes impact the microbiome at an individual level, with the ultimate goal of creating dietary interventions that can modulate the gut microbiome to improve health and wellbeing.

TEPKINLY® (EPCORITAMAB) RECEIVES SECOND EUROPEAN COMMISSION APPROVAL FOR THE TREATMENT OF ADULTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA

Genmab A/S (Nasdaq: GMAB) has announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) and Northern Ireland.

New APC PI Dr Sebastian Schmidt pictured with APC Director Prof Paul Ross and COO Dr Brendan Curran

“Follicular lymphoma can be challenging to treat and today’s approval of TEPKINLY for the treatment of relapsed/refractory follicular lymphoma after two or more lines of systemic therapy marks an important milestone for patients in the European Union who are in need of more options offering a balance of meaningful efficacy and favorable safety,” said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab. “Alongside our partner AbbVie, we are committed to exploring the continued development of epcoritamab as a potential core therapy across B-cell malignancies.”

FL is typically a slow-growing form of Hodgkin’s lymphoma (NHL) that arises from B-cell lymphocytes. FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases, and represents 10-20 percent of all lymphomas in the western world.i FL is considered incurable, and there is no standard of care treatment for third-line or later FL.i,ii Patients who achieve remission also often experience relapse.iii,iv,v

The conditional marketing authorization is supported by data from the Phase 1/2 EPCORE® NHL-1 clinical trial: an open-label, multi-cohort, multicenter, singlearm trial that evaluated TEPKINLY as monotherapy in patients with R/R FL after two or more lines of prior systemic therapy. Patients included in the study were refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent (70% having double refractory disease), patients who were refractory to last prior treatment (82%), and patients whose disease progressed within two years of initiating first systemic therapy (52%). The results published in the Lancet Haematology showed that patients treated with TEPKINLY (n=128) had an overall response rate (ORR) of 83% and a complete response (CR) rate of 63%. At a median follow-up of 16.2 months, the median duration of response was 21.4 months (13.7, NR). Duration of complete response (DOCR) was not reached.

The study included a planned separate optimization cohort, which evaluated 86 patients with the recommended 3-stepup doses for cytokine release syndrome (CRS) mitigation. Hospitalization was not mandatory in the cycle 1 optimization cohort. With the optimized regimen, 40% of patients experienced Grade 1 CRS and 9% experienced Grade 2 (no Grade 3 or higher CRS were reported). No immune effector cellassociated neurotoxicity syndrome

(ICANS) cases were reported in this cohort.

The safety profile of epcoritamab in the pivotal cohort was similar to reports of epcoritamab monotherapy in the pivotal EPCORE NHL-1 diffuse large B-cell lymphoma (DLBCL) cohort. In the pooled safety population (n=382), the most common adverse reactions (≥ 20%) with TEPKINLY were CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia, and diarrhea. The most frequent serious adverse reaction (≥ 10%) was cytokine release syndrome (34%). Fourteen patients (3.7%) experienced a fatal adverse reaction (pneumonia in 9 (2.4%) patients, viral infection in 4 (1.0%) patients, and ICANS in 1 (0.3%) patient.

“The approval of epcoritamab by the European Commission is a promising update for the lymphoma community,” said Kate Rogers, CEO of the Follicular Lymphoma Foundation. “Given that relapsed or refractory follicular lymphoma can be a very challenging form of cancer to treat, especially in later lines of therapy, it is critical that patients and physicians have additional options when it comes to treating this type of cancer.”

IRELAND’S FIRST ASIAM ACCREDITED AUTISMFRIENDLY CAMHS AT LUCENA CLINIC

St John of God Community Mental Health Services (CAMHS) at Lucena Clinic, a leading provider of mental health services for young people, today announces its formal accreditation as the first mental health service in Ireland to be recognised as autism-friendly by AsIAm.

This prestigious recognition underscores the service’s commitment to provide all young people with inclusive, compassionate, and supportive care. The accreditation, awarded by AsIAm, is testament to the service’s ongoing dedication to fostering an environment where all those attending feel respected, understood, and valued.

Community Mental Health Services is specifically a mental health service and not an autism service but at least 50% of young people who attend may also have a cooccurring diagnosis of autism or other neurodivergence. Therefore, the service needs to show leadership in neuroaffirmative practices. This new accreditation reflects the continuing efforts to integrate best practice and promote a culture of acceptance and understanding.

This project is funded by a ¤200k grant from the St John of God Foundation’s “Better Life” Programme. It encompasses six key components: a sensory and environmental audit, an evaluation of written communication, consultation with service users, staff training, a roadmap report, and a blueprint for creating an autistic and neurodivergentfriendly environment in other service settings.

In consultation with the autistic and wider neurodivergent community, this project seeks to extend the renowned St John of God hospitality to neurodivergent service users and their families and to improve the experience and engagement of all those involved in the service.

The project also involved partnering with ADHD Ireland, who contributed with consultation and by delivering staff training. The National Adult Literacy Agency (NALA) collaborated by reviewing communication documents to award the Plain English mark, as well as training staff. The project team at Community Mental Health services will continue to work closely with these organisations to ensure universal accessibility best practice.

The neurodiversity movement highlights the life-long and positive aspects of naturally occurring cognitive ‘differences’ such as creativity and passions as opposed to a focus on developmental deficits.

CORK HOSPITAL TRANSLATES CRUCIAL PATIENT INFORMATION INTO SIX LANGUAGES

A Cork hospital has begun translating complex health information into six different languages in a project which organisers say should be replicated nationwide.

Cork University Hospital Charity is funding the unique initiative at CUH to reflect the growing number of foreign national patients presenting at its breast radiology department.

Crucial patient care information is now available in Arabic, Lithuanian, Polish, Romanian, Ukrainian and Russian.

The pamphlets will explain in their native language what a mammogram, ultrasound or biopsy involves, risk factors to be aware of, breast symptoms and lifestyle advice.

“It will have a widespread impact. The information is there, not only for these patients, but for other patients into the future,” said Advanced Nurse Practitioner Susan Walsh of the Rapid Access Breast Service at CUH.

“Because we have so many nationalities residing in Ireland, it should be in all hospitals and part of the standard of care to provide information in as easy-tounderstand language as possible.”

Patient care information has already been produced in four different languages by the Breast Family History Service at CUH.

Most of the 5,500 new patients seen every year at the hospital’s symptomatic breast clinic will be further referred to the radiology department for diagnostic scans.

CUH collaborated on the translation project with the National Adult Literacy Agency (NALA), which helps remove barriers to people with literacy difficulties.

Census data from 2022 shows that the number of non-Irish citizens living in this country stands at almost 632,000 (12%) and to address the communications gap, a multi-disciplinary team from the breast radiology department set about reviewing patient letters and information.

The documentation was reviewed and edited over several months with NALA and achieved the ‘plain English’ mark before being translated into the six languages based on Census figures and the most frequently requested translators in the breast service.

The next step is transferring the common information onto an online platform.

“A lot of information is given to patients at these clinics and the main purpose is that what we provide to them is easily understood, regardless of nationality,” said Ms Walsh.

AIM FOR PROVEN SCIENCE

NEW

10 YEARS OF INNOVATION. A LIFETIME OF CHANGE.

We’re celebrating Alflorex®’s 10th birthday with a fresh new look! While the packaging has changed, the incredible 35624 ® strain you know and love remains the same. Additionally, we’re thrilled to introduce our NEW Alflorex®Children sachets.

Alflorex® Children brings you the benefits of our scientifically studied Bifidobacterium longum 35624 ® strain in a convenient and reliable dissolvable powder form that has a hint of vanilla.

Talk to our sales partner Pamex to learn more!

Email: info@pamex.ie | Phone: 094 9024000