HPN October 2024 - Honours Winners Edition

HOSPITAL PROFESSIONAL NEWS IRELAND

HPN October 2024 Issue 125 HOSPITALPROFESSIONALNEWS.IE

Ireland’s Dedicated Hospital Professional Publication

IN THIS ISSUE:

Hospital Professional

ONOURS 2024 WINNER'S EDITION

NEWS: Consultants support Digital Health Investment Page 5 REPORT: IPHA publishes New Manifesto Page 8 FEATURE: Updates in Psoriasis Page 12 CONFERENCE: Overview of ESMO 2024 Page 18 WOMEN'S HEALTH: Maternal Medicine Page 22

CPD: Abdominal Pain in Women Page 29 HONOURS: Hospital Professional Honours 2024 Winners Page 38 This Publication is for Healthcare Professionals Only

HOSPITAL PROFESSIONAL NEWS IRELAND Ireland’s Dedicated Hospital Professional Publication

Call for papers: make your contribution to Hospital Professional News  Articles  Research Papers  Reviews  Programme Descriptions  Reports Case Reports  Letters to Editor  Support fellow hospital professionals as well as aspiring junior professionals and early-year hospital pharmacists  Practice reports share innovations on any area of practice, including delivering clinical services, pharmacy administration, or new approaches to inform and engage with patients  Perspective articles focus on a specific field or discipline and discuss current advances or future directions, and may include original data as well as expert insight and opinions

Contact: Kelly Jo Eastwood at: kelly-jo@ipn.ie or Danielle Norton - danielle@hospitalprofessionalnews.ie

www.hospitalprofessionalnews.ie

October Issue Issue125

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Contents

Foreword

Greater Progression is needed for Pharmacy P4

Editor In one of our lead news stories this issue, we publish details of the newly published General Election Manifesto by IPHA. Central to this is an ask for the next Government to commit to a continuous and faster flow of new life-enhancing medicines, and vaccines, for patients in Ireland. The manifesto outlines innovative proposals on how this can be achieved.

New President elected at Irish Pharmaceutical Healthcare Association P8 New Innovation in Blood Pressure Treatment P13

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Advancements in Refracted Eye Surgery P14 ESMO 2024: Future Innovations P18 Hospital Professional Honours – The Winners P38

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The Red Carpet P56

Turn to page 8 to read the full story.

REGULARS

In other news, the European Society for Medical Oncology (ESMO) held its annual congress recently at the Fira Barcelona Gran Via. The ESMO 2024 comprehensive educational and scientific program fostered exchange and debate on translational cancer science, presented groundbreaking data, and encouraged multidisciplinary discussions to improve patient treatment. It also provided updates on cancer prevention, screening, and research breakthroughs, analysed clinical perspectives, and enhanced understanding of novel diagnostics and treatments.

Women’s Health: Perinatal Mental Health P20 Women’s Health: Microbiome-Gut Brain Axis P25

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Women’s Health: Polycystic Ovary Syndrome P26 CPD: Women’s Experience seeking healthcare for Abdominal Pain P29

Full coverage is on page 18.

Clinical R&D: P61

56

Hospital Professional News is a publication for Hospital Professionals and Professional educational bodies only.

ACCOUNTS Fiona Bothwell cs.ipn@btconnect.com

All rights reserved by Hospital Professional News. All material published in Hospital Professional 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 have 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.

SALES EXECUTIVE Avril Boyd avril@hospitalprofessionalnews.ie

PUBLISHER IPN Communications Ireland Ltd Clifton House, Lower Fitzwilliam Street, Dublin 2 (01) 669 0562 GROUP DIRECTOR Natalie Maginnis n-maginnis@btconnect.com EDITOR Kelly Jo Eastwood EDITORIAL danielle@hospitalprofessionalnews.ie

Commenting on the launch of the IPHA General Election Manifesto, Mr. O’Connor said, “Next year, IPHA members expect to make applications for reimbursement for 36 medicines which, according to most recent estimates, would positively benefit as many as 3,700 patients in Ireland, alongside their families and carers. However, we need to ensure that patients in Ireland will have fast and fair access to these new life-enhancing medicines next year, and in subsequent years, through multi-annual funding and reform of the current reimbursement process.”

SALES & TRAINING MANAGER Amy Evans | amy@ipn.ie 0872799317 CONTRIBUTORS Tass Miah | Mr Nakul Mandal Bernie Carter | Hannah Durand Dr Rachel Byrne | Dr Niamh Phelan Mr Frank Kinsella | Brian McGuire Dr Kirsty Hedding | Dr Angie Brown Dr Catherine Hinds Dr. Siobhán Corcoran Dr Siobhain O'Mahony Dr Mariarosaria Cuozzo Eibhlin Windrim Dr Genevieve Ferraris DESIGN DIRECTOR Ian Stoddart Design HOSPITALPROFESSIONALNEWS.IE

@HospitalProNews HospitalProfessionalNews

This October issue carries all the details of the 2024 winners of the Hospital Professional Honours, which were held in the Dublin Royal Convention Centre on September 14th with over 550 in attendance.

The Honours are the most influential and respected networking event, lauding excellence, innovation and service development; judged by key influencers including renowned respected experts. Their foundation lies in our collaboration with leading pharmaceutical companies; without whose investment and support, the event would not be possible.

We were overwhelmed with both the quantity and quality of the entries this year, making it an extremely difficult task for our esteemed judging panel. The winners are featured on pages 40-55.

I hope you enjoy the issue.

HOSPITAL PROFESSIONAL NEWS IRELAND Ireland’s Dedicated Hospital Professional Publication

HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

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News

Health System at a ‘Critical Juncture’ IMO President Dr Denis McCauley

of just 136 GPs with GMS/DVC contracts.

Speaking today, Dr Denis McCauley, President of the IMO, said: “Decades of insufficient planning and investment in our health system have left us at a critical juncture. In our hospitals, the system’s capacity has not kept pace with demand, resulting in overcrowding, patients on trollies, and prolonged waiting times in emergency departments.

The Irish Medical Organisation (IMO) has warned that a consistent failure to properly fund and resource the health system has left it at a “critical juncture” and facing a number of persistent and worsening crises in medical staffing, bed capacity and infrastructure.

The IMO acknowledges that funding for the health system has never been greater; however, this funding is merely allowing the health system to just stand still.

It has not been sufficient to adequately address the bed

capacity and staffing levels needed to effectively meet the demands of a growing and ageing population with ever more complex needs and to build a resilient health system for the future.

Selected key statistics:

• Hospital waiting lists have almost tripled to over 896,000 in the decade between 2013 and 2023 • 20% of consultant posts are either unfilled or filled on a temporary/locum basis

• In the last decade our population has grown by 14.4% to 5.3 million in 2023, with 15.3% of the population now aged 65 or over

• 83% of NCHDs routinely work more than 48 hours a week, leading to unsustainable levels of burnout and creating an unsafe working environment for doctors and patients

• There has been little or no increase in in-patient beds in the last 20 years

• Despite the major population increase, over the past decade there has been a net increase

“General Practice requires targeted measures to help doctors set up and grow practices while a comprehensive plan is needed to increase the number of consultants and non-consultant hospital doctor (NCHD) training posts in line with workforce requirements to ease the burden on overworked and burnt-out doctors who are doing their best in extremely difficult conditions.”

He added that a number of public health campaigns were needed as urgent priorities, including a well-funded public health strategy modelled on successful “tobacco free” policies to combat the harms related to social media; and a coordinated public health campaign to tackle vaccine hesitancy.

Greater Progression for Pharmacy Needed FIP President Paul Sinclair

Innovating pharmacy enhances patient care, improves therapeutic outcomes, addresses the dynamic challenges of health care, and propels the profession forward.”

He said that the application of three principles — integrity, performance and passion — would help facilitate the advancement of the profession.

Greater progression of the pharmacy profession is needed in order to address challenges such as inequitable healthcare access, medicines shortages, antimicrobial resistance, and substandard and falsified medicines, FIP president

Paul Sinclair said in his opening address at FIP’s 82nd World Congress of Pharmacy and Pharmaceutical Sciences.

The president also highlighted a need for innovation in pharmacy

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

to address public health challenges and disparities, citing pharmacy-based vaccination as an example of an innovative approach that has had high impact. He said: “Innovation is not just beneficial — it’s essential.

FIP’s passion for pharmacy had led it to create its “Think Health, Think Pharmacy” campaign to advance the profession, he said, and urged pharmacists from around the world to support it.

“Promoting our professional identity will facilitate more pharmacy services with benefits for our communities,” he added.

The FIP world congress was held in Cape Town, South Africa, from 1 to 4 September. Further details in the next issue of HPN.

News

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Could you help a future pharmacist?

APPEL (Affiliation for Pharmacy Practice Experiential Learning) is now seeking expressions of interest from pharmacists in community and hospital pharmacy settings who would like to facilitate an experiential learning placement for a 2nd-year pharmacy student in 2025.

Experiential learning placements are a key part of the integrated

pharmacy masters (M.Pharm).

Students undertake placements throughout the course and the 2nd-year placement is the first of these placements. These placements take place in two different ways: a two-week block for UCC and TCD students (13th – 24th January) and a longitudinal placement every Tuesday afternoon for RCSI students (7th January – 1st April).

Pharmacists who have previously facilitated APPEL placements have found the experience enjoyable and rewarding. In surveys, 83% of pharmacists said they would recommend facilitating a placement to other pharmacists.

The advantages of facilitating an APPEL placement include: • Continuing Professional Development - APPEL Trainer Training can contribute to pharmacists CPD, as can the experience of facilitating a placement.

• Development of your talent pipeline - many students will look to start their career in the organisations or practice

settings where they undertook their placements • Engagement - participating in the APPEL programme provides you with the opportunity to increase awareness of your pharmacy/organisation.

APPEL training and events provide fantastic networking opportunities.

Please register your interest in offering a placement (or placements) by filling in this short form: https://forms. gle/2haGCChzrzm8zvrz5 If you have any questions or want further information, please email ops@appel.ie.

Calls for Reform to Medical Negligence System The President of the Irish Medical Organisation (IMO) has called for reform of the medical negligence system in Ireland, saying that the current system was leading to unnecessary trauma for patients in a highly legalised and adversarial system and a culture of overreferrals which was putting pressure on an already over-burdened health system.

Dr Denis McCauley, a GP and Donegal Coroner, chaired IMO seminar in Dublin recently to discuss the medico-legal environment in Ireland. Dr McCauley said that the current system for medical negligence cases in Ireland, even taking into account recent legislative changes, is not in the best interests of patients or doctors with lengthy delays and costs leading to a change in how doctors will practice medicine. This is not always in the best interests of the patient and the dangers of over-referral and a culture of “defensive medicine” are bad for doctors, patients and the health system as a whole.

To counteract these unsatisfactory measures, Dr McCauley recommended that a system of no-fault compensation be introduced in Ireland, whereby the facts can be established and the patient can be compensated without the need to enter into lengthy costs legal battles which can compound the trauma for many years. “Such a system would be far more transparent, would enable the patient to have their issues addressed in a timely manner and would enable the doctor to concentrate on treatment and diagnoses without the overt threat of litigation.”

Consultants Support Digital Health Investment generative Artificial Intelligence (AI) can transform health systems, improving patient outcomes and overall productivity. The gap from where we are to where we need to be is stark.

The Irish Hospital Consultants Association (IHCA) has supported the Minister for Health’s call to roll out digital health records across the health service.

Commenting on a report that the Minister for Health, Stephen Donnelly TD is making the case at Cabinet level to use funding from the Apple ruling to invest in digital health, IHCA President, Professor Gabrielle Colleran said: “We fully endorse Minister Donnelly’s efforts to invest in a proper digital health system. In productivity and patient experience terms, it would be transformational.

“Our health system continues to rely on an antiquated records model which is desperately inefficient. It also means healthcare professionals are unable to access

“Digital health records are increasingly the norm globally, enhancing productivity, healthcare outcomes, and service experience for citizens.

“Previous attempts to introduce digital health systems here have been thwarted. Such shortsightedness has proven to be counterproductive. and assess patient records in a joined-up, real time fashion.

“Clipboards, paper, pens, pencils and fax machines remain realities in Irish hospitals. IT hardware

and software are dated and, in some instances, WiFi is not a given. This is at a time when governments around the world are turning their attention to how

“Now is the moment to move on digital health records. We have the means. We need the leadership and Minister Donnelly is to be commended to staking a claim for this investment.”

HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

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News

Surgical Guidelines Launched at RCSI Mr Padraic Regan, National Clinical Advisor for Plastic Surgery and the President of RCSI, Professor Deborah McNamara pictured with NCPS stakeholders

It promotes teamwork and communication by defining a care pathway which should support earlier diagnosis in the management of this rare, complex, multifaceted condition.

RCSI President Professor Deborah McNamara added, “I am very pleased to see the publication of these guidelines which will ensure a standardisation in the care of patients with this rare cancer. I extend congratulations to team involved in their development, and I thank them for their commitment to driving improvements in surgical care for the benefit of patients.”

Mr Padraic Regan, National Clinical Advisor for Plastic Surgery (NCPS), said, “The NCPS is delighted to launch this important BIA-ALCL clinical guideline. It is reassuring for the Plastic and Breast Surgeons to have this document available as a framework for care. More importantly, it offers reassurance to people impacted by this cancer, that their care will be informed by these evidenceinformed guidelines”

The National Clinical Programme in Surgery is a strategic initiative between the HSE and RCSI. The programme aims to design and implement change initiatives which improve and standardise the quality of care and access for all patients in a cost-effective manner. The programme works closely with other National Clinical and Care Programmes under the governance of the HSE CCO to ensure integration across multiple areas of care.

treatment and follow-up of this newly classified, rare lymphoma.

New surgical guidelines for the treatment of a rare form of non-Hodgkin lymphoma which can occur in patients with synthetic breast implants have been launched.

The Clinical Guideline on the Diagnosis and Treatment of Breast Implant Associated – Anaplastic Large Cell Lymphoma (BIA-ALCL), was commissioned by the HSE

National Clinical Advisor and Group Lead for Acute Operations.

It was launched at the 49th Sir Peter Freyer Surgical Symposium

by Mr Padraic Regan, National Clinical Advisor for Plastic Surgery and the President of RCSI, Professor Deborah McNamara.

The objective of this national clinical guideline is to provide standards for care in the diagnosis,

“Getting these guidelines published was a collaboration of many stakeholders and the NCPS is grateful to all those who contributed to this work”, added Mr Regan.

Women in Leadership Event The final Pharmaceutical Managers’ Institute Women in Leadership event of 2024 takes place on 16th October. The PMI are delighted to host Averil Power, CEO with the Irish Cancer Society as the guest speaker.

The WiL series is proudly supported by Uniphar Commercial.

Discovery of New Biological Pathway in IBD Researchers at the Francis Crick Institute, working with UCL and Imperial College London, have discovered a new biological pathway that is a principal driver of inflammatory bowel disease (IBD) and related conditions, and which can be targeted using existing drugs.

About 5% of the world’s population, and one in ten people in the UK, are currently affected by an autoimmune disease, such as IBD, the umbrella term for Crohn’s disease and ulcerative colitis.

These diseases are also becoming

more common, with over half a million people living with IBD in the UK as of 2022, nearly double the 300,000 previously estimated.

Despite increasing prevalence, current treatments do not work in every patient and attempts to develop new drugs often fail due to our incomplete understanding of what causes IBD. In research published in Nature today, scientists at the Crick journeyed into a ‘gene desert’ – an area of DNA that doesn’t code for proteins – which has previously

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

been linked to IBD and several other autoimmune diseases.

They found that this gene desert contains an ‘enhancer’, a section of DNA that is like a volume dial for nearby genes, able to crank up the amount of proteins they make.

The team discovered that this particular enhancer was only active in macrophages, a type of immune cell known to be important in IBD, and boosted a gene called ETS2, with higher levels correlating with a higher risk of disease.

Using genetic editing, the scientists

showed that ETS2 was essential for almost all inflammatory functions in macrophages, including several that directly contribute to tissue damage in IBD. Strikingly, simply increasing the amount of ETS2 in resting macrophages turned them into inflammatory cells that closely resembled those from IBD patients.

The team also discovered that many other genes previously linked to IBD are part of the ETS2 pathway, providing further evidence that it is a major cause of IBD.

Start Strong Go Long Deep and durable relief across psoriatic disease

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Tremfya 100 mg solution for injection in pre-filled pen PRESCRIBING INFORMATION. ACTIVE INGREDIENT(S): Guselkumab. Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATION(S): Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Treatment of active psoriatic arthritis in adult patients, alone or in combination with methotrexate, who have had an inadequate response or have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. DOSAGE & ADMINISTRATION: For use under guidance/supervision of physician experienced in diagnosis and treatment of conditions for which Tremfya is indicated. Subcutaneous injection. Avoid areas showing psoriasis. Adults: For both indications, 100 mg at weeks 0 and 4, followed by maintenance dose every 8 weeks. In the case of psoriatic arthritis, for patients at high risk for joint damage according to clinical judgement, consider a dose of 100 mg every 4 weeks. Consider discontinuation if no response after 16 weeks of treatment for plaque psoriasis and 24 weeks for psoriatic arthritis. Children: No data available in children/adolescents <18 years. Elderly: No dose adjustment required, limited information in subjects aged ≥ 65 years, very limited information > 75 years. Renal & Hepatic impairment: Not studied.

CONTRAINDICATIONS: Serious hypersensitivity to active substance or excipients; clinically important, active infection. SPECIAL WARNINGS & PRECAUTIONS: Infections: Potential to increase risk. If signs/ symptoms of clinically important chronic/acute infection occur, monitor closely and discontinue Tremfya until resolved. Tuberculosis: Evaluate patients for TB pre-treatment; monitor for signs/ symptoms of active TB during and after treatment. Consider anti-TB therapy prior to Tremfya if past history of latent/active TB and adequate treatment course not confirmed. Serious hypersensitivity reaction: Includes anaphylaxis. Some serious hypersensitivity reactions occurred several days after treatment and included urticaria and dyspnoea. If occurs, discontinue Tremfya immediately and initiate appropriate therapy. Hepatic Transaminase Elevations: An increased incidence of liver enzyme elevations has been observed in patients treated with Tremfya q4w compared to patients treated with Tremfya q8w or placebo. When prescribing Tremfya q4w in psoriatic arthritis, consider evaluating liver enzymes at baseline and thereafter according to routine patient management. If increases in ALT or AST are observed and drug-induced liver injury is suspected, Tremfya should be temporarily interrupted until this diagnosis is excluded. Immunisations: Consider completing all appropriate immunisations prior to Tremfya. Do not use live vaccines concurrently with Tremfya; no data available; before live vaccination, withhold Tremfya for at least 12 weeks and resume at least 2 weeks after vaccination. SIDE EFFECTS: Very common: Respiratory tract infection. Common: headache, diarrhoea, arthralgia, injection site reactions, transaminases increased. Other side effects: hypersensitivity, anaphylaxis, rash, herpes simplex infections, neutrophil count decreased. Refer to

Scan this QR code for more information

SmPC for other side effects. LEGAL CATEGORY: Prescription Only Medicine (POM). PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S): Pre-filled pen, X1, EU/1/17/1234/002.

MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER INFORMATION IS AVAILABLE FROM: Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, IRL - Co. Cork, P43 FA46. Prescribing information last revised: July 2022.

Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse events via: HPRA Pharmacovigilance Website: www.hpra.ie. Adverse events should also be reported to Janssen Sciences Ireland UC on 1800 709 122 or at dsafety@its.jnj.com.

References: 1. Reich K. et al., Five-year maintenance of clinical response and improvements in healthrelated quality of life in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2. British Journal of Dermatology, 2021, June. https://doi.org/10.1111/ bjd.20568. 2. Blauvelt A, Papp KA, Griffiths CEM, et al. Efficacy and safety of guselkumab, an antiinterleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placeboand active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol 2017;76:405-17. 3. Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an antiinterleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76:418-31. 4.

McInnes IB, et al. Long-Term Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19 Subunit of Interleukin-23, Through Two Years: Results From a Phase III, Randomized, DoubleBlind, Placebo-Controlled Study Conducted in Biologic-Naive Patients With Active Psoriatic Arthritis.

Arthritis Rheumatol. 2022 Mar;74(3):475-485. 5. Mease PJ, et al. Guselkumab in biologic-naïve patients with actives psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet 2020;395:1126-1136. 6. Ritchlin CT, et al. Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvements in signs and symptoms if active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced.

RMD Open. 2021;7:e001457. 7. Deodhar A et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had a previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet 2020; 395:1115-1125. 8. TREMFYA® Summary of Product Characteristics, available at medicines.ie.

CP-430955 | Date of Preparation: February 2024

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News

IPHA Publishes New Manifesto Shane Ryan, IPHA President

“We believe that doctors should have the right medicine available for prescription for their patients at the right time and are therefore calling for a new voice for doctors in prioritising new medicines for patients” The Board of the Irish Pharmaceutical Healthcare Association (IPHA), the representative body for the research-based biopharmaceutical industry in Ireland, is pleased to announce Shane Ryan as its new President.

Shane is the General Manager for Takeda in Ireland and has retained this role for over six years, carrying with him a track record of success through clarity of purpose and vision. Caitriona Duggan, Country President for Amgen in Ireland, becomes VicePresident. Mr Ryan takes over the role from Biogen’s Michael O’Connell after his two-year term.

Transparent partnerships and building trust with stakeholders across Government, the Department of Health and the Health Service Executive will play a key role in Shane’s presidency, which will focus on driving forward decisions that both value innovation and improve health outcomes for all.

Commenting on this, Shane Ryan, General Manager, Takeda Ireland shared, “I am honoured to serve IPHA members, representing a sector at the forefront of discovering, developing and bringing life-changing medicines and innovation to patients, clinicians and the communities that support them. It is a pivotal time – the recent elections of the European Parliament and the upcoming Irish general election present exciting opportunities for us to work in collaboration with others to achieve our vision of creating an environment which helps patients and places Ireland as the investment destination for life sciences.”

Oliver O’Connor, Chief Executive of IPHA, welcomed the appointments.

“I am delighted to welcome Shane and Caitriona to their respective new roles. They bring experience and expertise at a critical time for the industry in Ireland and globally. As we continue to engage in the

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

reform of the EU Pharmaceutical Legislation, plan ahead to work with the next Government in Ireland and prepare for a new Framework Agreement, I look forward to supporting their goal in creating an innovative, competitive ecosystem which benefits all patients in Ireland”, said Mr O’Connor.

IPHA also publishes its General Election manifesto and central to this is an ask for the next Government to commit to a continuous and faster flow of new life-enhancing medicines, and vaccines, for patients in Ireland. The manifesto outlines innovative proposals on how this can be achieved.

Commenting on the launch of the IPHA General Election Manifesto, Mr. O’Connor said, “Next year, IPHA members expect to make applications for reimbursement for 36 medicines which, according to most recent estimates, would positively benefit as many as 3,700 patients in Ireland, alongside their families and carers. However, we need to ensure that patients in Ireland will have fast and fair access to these new life-enhancing medicines next year, and in subsequent years, through multi-annual funding and reform of the current reimbursement process. Over the next couple of months, in the lead up to the next General Election in Ireland, we look forward to presenting to candidates, and other stakeholders our proposals on how this can be achieved.

“We believe that doctors should have the right medicine available

for prescription for their patients at the right time and are therefore calling for a new voice for doctors in prioritising new medicines for patients. We would also like to see a levelling-up of care for patients with rare diseases through faster access to the medicines they need.

“To further these goals, industry is ready to play its part in speeding up the process and reaching a new Framework Agreement with the State in 2025. Since the last Agreement in 2021, IPHA member companies have actively delivered significant savings to the State well above what had been anticipated for the full fouryear period of the Agreement.

As we start planning for the next Agreement, we remain ready and willing to collaborate to achieve certainty for clinicians and patients to bring newly-authorised medicines to the Irish healthcare system as quickly as possible.

“An innovative life-science sector is of strategic importance to Ireland and Europe. IPHA companies are key contributors to R&D and clinical trials which improve patient outcomes and quality of life here and around the world. However, currently in Ireland we need to do better in terms of the numbers of clinical trials being conducted.

We want to give patients hope through faster access to research treatments. We welcome the recent establishment of a new National Clinical Trials Oversight Group by the Minister for Health to support innovation and patient outcomes and we look forward to seeing its outputs. In particular, we support the Minister’s goal of doubling the number of clinical trials in Ireland. We believe this can be achieved over the lifetime of the next Government with clear and sustained political support.”

“In order to achieve all this and remain at the forefront of innovation and efficiency, it is crucial that we continue to upskill, both through the development of the next generation of talent and the adoption of new technologies.

To place our sector at the cutting edge of data, digital and technology we need to work with all partners to develop the next generation of pharmaceutical leaders. This will be fundamental to creating better experiences for patients, providers and payers while also driving investment and supporting the establishment of a globally competitive ecosystem”.

News

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Breaking Down Barriers University of Galway and Chronic Pain Ireland Host Event on Sex and Gender in Chronic Pain The University of Galway, in collaboration with Chronic Pain Ireland, the Centre for Pain Research, and the PPI Ignite Network, will host a national eventtitled "Exploring Sex and Gender in Chronic Pain" on October 11, 2024, from 2:00-4:00 PM. The event will take place at the Human Biology Building on the University campus as part of the National Patient and Public Involvement (PPI) Festival.

This event will also be streamed online, making it accessible to participants worldwide.

Chronic pain affects over 150 Million people throughout Europe and can persist for months or years, often with significant variations between men and women. The event, moderated by TV presenter and author Andrea Hayes, aims to shed light on the critical role sex and gender play in the diagnosis, treatment, and management of chronic pain.

This event is an essential platform for healthcare professionals, academics, researchers, patient advocacy groups, patients and the general public. It will inform and challenge how chronic pain is viewed across genders, and aims to influence both healthcare and policy.

of Galway, will present findings from the PAINDIFF Network.

This network, which focuses on understanding current approaches and developing guidelines for the study of sex and gender differences in pain research.

She said, "Implementing guidelines and recommendations for studying sex and gender differences in pain research will ensure that research findings are robust and translatable, ultimately leading to better pain management strategies for all people living with chronic pain.

This event will be hosted by TV presenter and author Andrea Hayes.

Professor Brian McGuire, Clinical Psychologist and Co-Director Centre of Pain Research, University of Galway, will provide insights into the wider implications.

Dr. Michelle Roche, Associate Professor in Physiology and Co-Director of the Centre for Pain Research at the University

He added, "Recognising sex and gender differences in chronic pain is essential to developing more personalised treatments. Our goal

is to translate this understanding into better outcomes for patients."

(Dr. Rosemary Keane, Mater Hospital)

The event will also feature Ms. Martina Phelan, Chairperson of Chronic Pain Ireland, will also speak at the event. In her role she emphasises the importance of the patient voice in shaping healthcare.

 The patient’s voice in research (Martina Phelan, Chronic Pain Ireland)

"Lived experiences must be at the heart of research. By including patients in the conversation, we ensure that the solutions developed genuinely address the realities of chronic pain,” said Martina.

Key Topics at the event will include:  Research findings on sex and gender in pain (Dr. Michelle Roche)

 Incorporating research into health policy (Dr David Moore, Beaumont Hospital) This event is an essential platform for healthcare professionals, academics, researchers, patient advocacy groups, patients and the general public. It promises to not only inform but to challenge how we view chronic pain across genders, aiming to influence both healthcare and policy.

 Gender differences in pain management (Prof. Brian McGuire)

For more details and registration: https://ppinetwork.ie/event-listing/ exploring-sex-and-gender-inchronic-pain/

 Real-world clinical experiences of treating gender-based pain

For more information visit https:// chronicpain.ie

New Clinical Lead for Emergency Medicine Dr Rosa McNamara has been appointed as HSE’s Clinical Lead for the National Clinical Programme (NCP) for Emergency Medicine.

Dr McNamara is a consultant in emergency medicine, working with the St Vincent’s University Hospital.

She is Associate Clinical Professor at University College Dublin and Chair of the Geriatric Emergency Medicine Special Interest Group at the International Federation for Emergency Medicine.

The National Clinical Programme for Emergency Medicine, operated in partnership between the HSE and RCSI, is responsible for providing a framework for the delivery of appropriately prioritised high-quality emergency care to

the patients who present to our emergency departments. These patients present with emergencies of all types encompassing a wide range of severity from the small number with immediately lifethreatening conditions to those whose condition is found to be less serious after appropriate assessment.

Professor Deborah McNamara, RCSI President, said: “The National Clinical Programme for Emergency Medicine is a really important strategic initiative between the HSE and RCSI, working to develop and deliver change initiatives which improve patient care in emergency medicine. I am delighted to welcome Dr McNamara in her

Dr Rosa McNamara, HSE Clinical Lead, National Clinical Programme for Emergency Medicine

new role as clinical lead and I look forward to working with her as she progresses with the programme’s critical work.”

HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

10 News

¤32m Research Centre opens at Connolly Professor Cathal Kelly, Vice Chancellor and CEO/Registrar, RCSI; Jack Chambers T.D., Minister for Finance; Professor Deborah McNamara, President, RCSI

operating theatre, practical skills rooms and a large public area.

The new facility will also provide increased capacity for RCSI's translational research and will be the location for a new clinical research centre.

A new ¤32 million Education and Research Centre (ERC) at Connolly Hospital was officially opened today by RCSI University of Medicine and Health Sciences.

RCSI President Deborah McNamara formally opened the new facility in the presence of Minister for Finance, Jack Chambers T.D. and Minister for Children, Equality, Disability, Integration and Youth, Roderic O’Gorman T.D. The new centre joins the Smurfit Building, Education and Research Centre at Beaumont Hospital as RCSI's second major clinical centre of academic excellence in Ireland.

Designed by McCauley Daye O'Connell Architects and constructed by Felix O'Hare & Co Ltd. the three-storey building is designed with two distinct interlocking blocks for student, academic, faculty and administration functions with a communal atrium area linking both, providing amenity and support space for students and staff.

Funded by the HSE, a new Hospital Integrated Pathology laboratory is situated on the second floor and will replace the existing hospital laboratory. This state-of-the-art facility will significantly enhance laboratory capacity in the hospital, providing essential diagnostic capacity for the communities of West Dublin, North Kildare and South County Meath.

The Centre will greatly enhance the student experience for the Graduate Entry Medicine students based at Connolly and for all other RCSI students while on clinical rotations at the hospital. Along with tutorial rooms and a large lecture theatre, it includes a mock

Minister for Finance, Jack Chambers T.D. said: "This new Education and Research Centre is an important addition to Connolly Hospital in Blanchardstown.

RCSI is at the forefront of health sciences education in Ireland and internationally. This new centre

gives students a dedicated space to learn and hone their skills in a state-of-the-art facility as well as providing additional capacity for cutting-edge research. I am particularly pleased that the building also includes new HSE pathology laboratories. This is a great example of an academic institution working in partnership with the health service for the benefit of medical students, patients and the local community."

Professor Cathal Kelly, ViceChancellor, RCSI University of Medicine and Health Sciences said: “We are delighted to officially open the new RCSI Education and Research Centre at Connolly Hospital. This futurefocused development reflects the University's commitment to Connolly hospital and the broader RCSI Hospital Group, as well as our long-standing partnership with the HSE. It will provide a world-class learning environment for the RCSI students at Connolly, as well as additional research infrastructure.”

“The inclusion of a new HSE pathology laboratory is a reflection of the strength of our partnership with the HSE, as well as our commitment to supporting improvements in patient care”, added Professor Kelly.

New Appointment at Mercy University Hospital Ms Margaret McKiernan, Chief Executive Officer

Group and is the acute hospital representative in Cork on the LGBT Interagency Group. Ms McKiernan established the Sanctuary Hospital Group within Mercy University Hospital which has hospital and interagency membership to support the delivery of HSE Inclusion Health priorities.

Speaking about the appointment, Ms McKiernan said; “I am honoured to take up this position and to lead Mercy University Hospital into its next chapter.

My commitment is to build upon our strong foundation of compassionate, patient-centred care while embracing innovation and collaboration to best serve our community. Working with partners across health, social care and the voluntary sector, I will guide the hospital’s ambition to provide the right services to meet the health and care needs of our communities both now and in years to come”.

Following a competitive recruitment process, the Board of Directors of Mercy University Hospital (MUH) is pleased to announce the appointment of Ms Margaret McKiernan as Chief Executive Officer.

recently serving as MUH’s Director of Nursing since 2016. In this capacity, she played a key role in the executive management of the hospital, overseeing capital developments and the patient experience pathway.

roles in Ireland and the UK, Ms McKiernan’s professional and academic qualifications include an MSc in Nursing and a post graduate qualification in Intensive Care and Coronary Care Nursing. Most recently, she successfully completed the Florence Nightingale Foundation Scholarship Programme 2022 to 2023. Her clinical background lies in critical care nursing, with specialist interests in healthcare communication, end-of-life care, and inclusion health.

Ms McKiernan brings over 25 years of experience in the acute hospital sector to the role, most

A Registered General Nurse with a distinguished career spanning clinical and leadership

Ms McKiernan represents acute hospitals nationally on the HSE / Irish Hospice Foundation Oversight

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

Scan QR for more info

« Indicated for Plaque Psoriasis, Paediatric Plaque Psoriasis, Psoriatic Arthritis, Crohn’s Disease1 « The NEW ustekinumab biosimilar from Clonmel Healthcare1 « Uzpruvo is the first approved ustekinumab biosimilar in Ireland

Cost-effective option enabling improved access to ustekinumab treatment

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

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

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

PFS - pre-filled syringe. *Stelara®; †29 vs 27-gauge needle of the reference product, Stelara®1,3; ††Plunger stopper made of bromobutyl rubber.

1. Uzpruvo® SmPC (Feb. 2024); 2. Feldman SR et al. Expert Opin Biol Ther. 2023;23(3):253-60. DOI: 10.1080/14712598.2023.2235263; 3. Stelara® PI (Aug. 2022).

UZPRUVO 45 & 90 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE This medicinal product is subject to additional monitoring.

Uzpruvo 45 mg: Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL. Uzpruvo 90 mg: Each pre-filled syringe contains 90 mg ustekinumab in 1 mL. Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology. Presentation: Pre-filled glass syringe. Indications: Uzpruvo is indicated for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease. Dosage: Uzpruvo is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which Uzpruvo is indicated.

Refer to Summary of Product Characteristics. Method of administration: Subcutaneous injection.

Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important, active infection. Warnings and precautions: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and Uzpruvo should not be administered until the infection resolves. Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. Serious hypersensitivity reactions have been reported in the postmarketing setting, in some cases several days after treatment.

Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have been reported during post-approval use of ustekinumab. Risk factors for cardiovascular disease should be regularly assessed during treatment with ustekinumab. It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with Uzpruvo. Caution should be exercised when considering concomitant use of other immunosuppressants and Uzpruvo or when transitioning from other immunosuppressive biologics.

It is not known whether ustekinumab may affect allergy immunotherapy. In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment. Cases of lupus-related conditions have been reported in patients treated with Ustekinumab. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the

elderly. Interactions: Live vaccines should not be given concurrently with Uzpruvo. In psoriasis studies, the safety and efficacy of ustekinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn’s disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of Ustekinumab. Fertility, pregnancy and lactation: Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment. There are no adequate data from the use of ustekinumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Uzpruvo in pregnancy. Limited data from published literature suggests that ustekinumab is excreted in human breast milk in very small amounts. Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with Uzpruvo must be made taking into account the benefit of breast-feeding to the child and the benefit of Uzpruvo therapy to the woman. The effect of ustekinumab on human fertility has not been evaluated. Driving and operation of machinery: Uzpruvo has no or negligible influence on the ability to drive and use machines. Undesirable effects: Upper respiratory tract infection, nasopharyngitis, sinusitis, dizziness, headache, oropharyngeal pain, diarrhoea, nausea, vomiting, pruritus, back pain, myalgia, arthralgia, fatigue, injection site erythema, injection site pain. Refer to Summary of Product Characteristics for other adverse effects. Adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Pack size: 1 pre-filled syringe. A copy of the Summary of Product Characteristics is available upon request or go to www.clonmelhealthcare.ie.

Marketing authorisation holder: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany. Marketing authorisation number: EU/1/23/1784/001,004. Medicinal product subject to restricted medical prescription. Date last revised: February 2024.

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

12 Psoriasis

Updates in Psoriasis Written by Tass Miah, The Psoriasis Association

body) or biologics (injections that target specific parts of the immune system). Holistic approaches such as making changes to diet or lifestyle may also improve symptoms of psoriasis.

When should someone contact their GP? If you notice any changes to your skin or a new itchy, scaly rash it is advisable to contact your GP to book an appointment at your earliest convenience.

Guttate psoriasis is characterised by small, scaly patches. Rare forms include generalised pustular psoriasis (GPP), which causes small blisters, and erythrodermic psoriasis, affecting skin condition and body temperature. If you suspect you have GPP or erythrodermic psoriasis, it is important to seek immediate medical attention as both types can be serious.

What causes psoriasis?

World Psoriasis Day is celebrated annually on 29th October across the world. In the UK, Psoriasis Awareness Week, also runs at the end of October and incorporates World Psoriasis Day. Its aim is to raise awareness of psoriasis and psoriatic arthritis. The theme for 2024 is community.

skin tone. On darker skin, they may appear as purple or brown patches with grey scales, while on lighter skin, they often present as pink or red patches with silverywhite scales. Plaques can vary significantly in shape and size, ranging from small spots to several centimetres wide.

What is psoriasis?

Psoriasis can cause discomfort, with affected areas often feeling itchy and sore. It is important to note that psoriasis is not contagious—it cannot be transmitted between individuals or spread from psoriatic to nonpsoriatic skin.

Psoriasis is an immune-mediated inflammatory disease (IMID) primarily affecting the skin but also commonly associated with psoriatic arthritis (PsA), which impacts the joints.

In the United Kingdom and Ireland, psoriasis affects approximately 2% to 3% of the population. This condition results from an accelerated skin cell replacement process.

Typically, skin cells are replaced every 21-28 days. However, in individuals with psoriasis, this cycle is significantly shortened to just a few days. As a result, there is an excessive accumulation of skin cells on the skin’s surface, forming psoriatic plaques.

How to identify psoriasis?

Dry, thick, and raised patches on the skin are the most common sign of psoriasis. These patches are known as ‘plaques’ and are often covered with a silvery-white or grey coating called scale.

The appearance of psoriatic plaques can differ based on

Currently, there is no cure for psoriasis, but a range of treatments and lifestyle adjustments are available to help individuals manage the condition effectively and maintain a good quality of life.

Are there different types of psoriasis?

There are many different types of psoriasis, with plaque psoriasis being the most common, affecting around 80% of individuals.

It presents as silvery or grey plaques most commonly on elbows, knees, lower back and scalp. Scalp psoriasis can make the scalp feel itchy and tight, and cause dandruff-like flakes.

Other types include guttate psoriasis, commonly affecting children and teenagers, often triggered by throat infections.

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

The precise role of genetics in psoriasis development, is complex, however, psoriasis can run in families.

Research shows the psoriasiscausing changes in the skin begin in the immune system when certain immune cells (T cells) are triggered and become overactive.

In most cases, psoriasis develops following a ‘trigger’.

For example, an infection, injury to skin (Koebner’s Phenomenon) or hormonal changes may lead to psoriasis.

Other triggers such as stress, diet, medication, alcohol or smoking may also cause psoriasis. These triggers can contribute to psoriasis getting worse or flaring.

How can psoriasis be treated?

There are four main types of psoriasis treatment. Depending on the type of psoriasis you have, and how severe it is determines the treatment you will receive.

Topical treatments (applied directly to the skin) are often the first line of treatment. Moisturisers, emollients, coal tar preparations and vitamin D based topicals may be prescribed by your doctor.

The following courses of action are recommended for psoriasis that doesn’t respond to these treatment types. Phototherapy (controlled exposure to UVB or UVA light in a phototherapy unit), systemics (taken orally and affect the entire

For those already diagnosed with psoriasis, if your current treatment is not working or your psoriasis is worsening, do get back in touch with your GP. A GP can diagnose psoriasis by examining your skin or scalp.

If your doctor is unsure or your condition is severe, they may refer you to a dermatologist (skin specialist).

Can I see a specialist?

If your psoriasis is not improving with treatment, covers more than 10% of your body, affects sensitive areas (e.g. your face or genital area), or is impacting your mental health or daily life, your GP can refer you to a dermatologist.

Dermatologists have access to a wider range of treatments in comparison to primary care.

Can community pharmacists support people with psoriasis?

There are many treatment options available over the counter (OTC) for psoriasis.

This includes moisturisers and emollients, as well as coal tar shampoo and salicylic acid treatments which can treat scalp psoriasis. Pharmacists can familiarise themselves with these OTC psoriasis treatments.

Pharmacists should encourage proper usage of these treatments and following dosage guidelines.

This way, if patients return with symptoms or symptoms worsen, they can advise patients to see their GP. Pharmacists may also direct patients to The Psoriasis Association or provide them with relevant literature, such as leaflets and information sheets.

Are there any current issues or advancements surrounding psoriasis care?

Skin of Colour: Psoriasis in individuals with skin of colour can be underdiagnosed, requiring

13 special treatment considerations, including addressing dyspigmentation and adjusting phototherapy.

Impact on Mental Health: Psoriasis is not just a skin condition; it also has significant psychosocial impacts, including anxiety and depression. Few patients seek help, however, early treatment, including therapy and medication, is essential for managing these comorbidities.

introduced a "Patient-Initiated Follow-Up" (PIFU) system. Dr Julia Schofield, Psoriasis Association Chair, shares “PIFU provides a flexible way for patients to stay ‘on the books’ of the specialist service so that they can reaccess care in a timely fashion as and when necessary, without needing a new referral.” The PIFU system is especially beneficial for managing unpredictable flare-ups of psoriasis.

Access to Specialist Care: Historically, people with chronic conditions affecting the skin, like psoriasis, faced difficulties in reaccessing specialist dermatology services after being discharged to primary care. Often, this required a new referral and a long wait to see a specialist when the condition flared up. However, the NHS has

Advancements in Treatment: New biosimilar versions of Ustekinumab for managing psoriasis and PsA are now available, following the expiration of Stelara's patent in July 2024. This milestone introduces new treatment options for those living with these conditions, potentially improving management and outcomes.

AI in Dermatology: Another significant development is the increasing use of artificial intelligence (AI) in dermatology, which is enhancing the diagnosis and monitoring of skin diseases like psoriasis. AI technologies are expected to play a crucial role in improving the accuracy and efficiency of psoriasis care in the future.

Additional Information If you're seeking more information or support, visit the Psoriasis Association. The UK's leading national charity and membership organisation for people affected by psoriasis and psoriatic conditions. The charity supports individuals through funding research, providing information and raising awareness. You can find more out about The Psoriasis

Association and the work they do via their website at www.psoriasis-association.org. uk and @psoriasisuk across social media channels.

(Registered Charity Number: 1180666 Scotland: SC049563) Website - https://www.psoriasisassociation.org.uk/ Instagram - https://www. instagram.com/psoriasisuk/ Twitter - https://twitter.com/ PsoriasisUK LinkedIn - https://uk.linkedin. com/company/psoriasisassociation Facebook - https://www. facebook.com/PsoriasisUK

News

New Innovation in Blood Pressure Treatment Donegal patient Francis Hegarty became the 50th patient to undergo the Renal Denervation (RDN) procedure at Galway University Hospitals; a minimally invasive procedure to help treat high blood pressure in patients who have not responded to medications and lifestyle changes.

Galway University Hospitals were the first hospital in the country to carry out the RDN procedure, and the first internationally to offer RDN as a day-case surgery. This means that patients arrive at the hospital in the morning, have their procedure, and then return home the same day.

Following a number of successful clinical trials at GUH, the RDN procedure went mainstream in 2021. And just recently, on 30 August, the European Society of Cardiology (ESC) updated its guidelines for the management of elevated blood pressure and hypertension incorporating recommendations for the first time on the use of renal denervation to treat various types of hypertension.

These ESC guidelines state that RDN may be considered, after a shared decision with the patient about risks and benefits and only in hospitals like GUH that undertake medium to high volumes of this procedure, among patients with resistant hypertension (not responsive to 3 or more medications) or among patients with very high risk of cardiovascular disease who have uncontrolled hypertension.

Francis Hegarty from Teelin in County Donegal and Prof Faisal Sharif, Consultant Interventional Cardiologist at GUH and University of Galway.

“Approximately 35% of the adult population in Ireland have high blood pressure and around one third of these patients are taking medication but their blood pressure is still uncontrolled. If we are able to control blood pressure adequately overtime than we can reduce the risk of end-organ damage. Even a small reduction in blood pressure can lead to a significant reduction of the risk of stroke or heart attack,” explains Prof Faisal Sharif, Consultant Interventional Cardiologist at GUH and University of Galway.

“Renal denervation is indicated for very high-risk patients with uncontrolled blood pressure or resistant hypertension. First line of treatment is lifestyle changes and adherence to blood pressure medications. If these measures are insufficient to control the blood pressure or patient has intolerance to blood pressure medications, then RDN may be considered. The

treatment is optional and is offered to patients who fit the criteria.

“It’s a minimally invasive procedure involving catheterisation through the femoral artery in the thigh, to deliver radiofrequency or ultrasound waves to the nerves surrounding the renal arteries. This process disrupts the overactive sympathetic nerve activity, leading to a reduction in blood pressure.

Following the procedure, patients are monitored with a 24-hour blood pressure monitor every three months for the first year, and then annually for the next five year.

“Providing this approach as day case procedure has significant benefits for patients in terms of reduced disruption to their lives, recovery at home and we are not

dependent on the availability of beds for an overnight stay which can be a challenge with the current demands on inpatient care, added Prof Sharif.

Prof Bill McEvoy, a Consultant Cardiologist at University Hospital Galway, Professor of Preventive Cardiology at University of Galway and co-Chair of the ESC guidelines for the management of elevated blood pressure and hypertension said, "The ESC guidelines include evidence-based recommendations that provide guidance for clinicians and their patients on the use of this important new technology.

However, it must be stressed that this RDN procedure needs to be undertaken in a centre where there is expertise and experience.”

HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

14 Eye Surgery

Exploring the Latest Advancements in Refractive Eye Surgery Written by Mr Nakul Mandal, MRCOphth, PhD, FEBO, PgDip CRS, Consultant Ophthalmic Surgeon, Blackrock Health Galway Clinic Mr Frank Kinsella, MRCPI, FRCOphth, FWCRS, Consultant Ophthalmic Surgeon, Blackrock Health Galway Clinic Mr Frank Kinsella

refractive error severity, and overall eye health. Preoperative evaluations, including corneal topography and wavefront analysis, are essential to determine the most suitable procedure for each patient.

Mr Nakul Mandal

Introduction Refractive surgery encompasses a range of procedures designed to correct or minimize refractive errors such as myopia (nearsightedness), hyperopia (farsightedness), astigmatism, and presbyopia. With continuous advancements in technology, the options for refractive surgery have become more diverse, offering patients further choices tailored to their specific needs.

Laser Refractive Surgery Laser in Situ Keratomileusis (LASIK) is one of the most wellknown and commonly performed refractive surgeries. It involves creating a thin flap on the cornea using a femtosecond laser or microkeratome. The underlying corneal tissue is then reshaped with an excimer laser to correct the refractive error, and the flap is repositioned. Wavefront-Guided and Topography-Guided LASIK use detailed measurements of the eye's optical system, creating a customized treatment plan to improve visual quality. LASIK provides quick recovery and high success rates, making it a popular choice for patients with myopia, hyperopia, and astigmatism.1 Indeed, the US Patient-Reported Outcomes With Laser In Situ

Keratomileusis (PROWL) Studies showed that the vast majority of patients were satisfied with their treatment.2 Photorefractive Keratectomy (PRK) is a surface ablation technique where the corneal epithelium is removed, and the underlying corneal tissue is reshaped with an excimer laser. Unlike LASIK, PRK does not involve creating a corneal flap, making it a more suitable option for patients with thinner corneas. Though recovery time is longer compared to LASIK, the visual outcomes are similar.3 Small Incision Lenticule Extraction (SMILE) is a minimally invasive procedure that uses a femtosecond laser to create a small lenticule (a thin disc of corneal tissue) within the cornea.

This lenticule is then removed through a small incision, reshaping the cornea and correcting the refractive error. SMILE may offer certain benefits such as the reduction of dry eye symptoms.4 Intraocular Lenses Refractive Lens Exchange (RLE) involves removing the natural lens and replacing it with an artificial intraocular lens (IOL). This procedure is similar to cataract surgery and is commonly used

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

to correct myopia, hyperopia, astigmatism, and presbyopia.

Modern IOL options include toric lenses, which correct astigmatism, and multifocal lenses, which create multiple focal points to provide unaided vision at near, intermediate, and far distances.

Extended Depth of Focus (EDOF) lenses are designed to provide a continuous range of focus, offering excellent unaided distance and intermediate vision, with reasonable near vision.5 Phakic Intraocular Lenses (PIOLs) are advanced vision correction devices implanted in the eye while preserving the natural lens. They are primarily used for patients with high refractive errors or those who are not suitable candidates for laser eye surgery. Given its success and the evolving landscape of refractive surgery, it is anticipated that the indications for PIOLs will broaden in the future, making them a more common option for a wider range of patients. PIOLs can be implanted in either the anterior chamber (between the cornea and iris) or the posterior chamber (behind the iris). The Visian ICL (STAAR Surgical), a popular posterior chamber PIOL, is particularly renowned for its excellent visual outcomes and safety profile.6 Safety and Patient Considerations Refractive surgery has a high success rate, but it is crucial to consider patient-specific factors such as corneal thickness,

Possible side effects of refractive surgery may include dry eye, glare, and halos. While most of these issues resolve over time, some patients may experience persistent symptoms. Serious complications, such as infection or ectasia (corneal weakening), are rare but can occur. It is important for patients to follow postoperative care instructions and attend all follow-up appointments to ensure optimal outcomes.

Future Directions The field of refractive surgery continues to evolve with ongoing research and technological advancements. Future developments may include: • Artificial Intelligence (AI) and Machine Learning: AI algorithms can enhance preoperative evaluations and improve patient selection, leading to better surgical outcomes.

• Stromal Lenticule Implantation: Lenticules removed during SMILE procedures can potentially be used to treat hyperopia or presbyopia, offering a novel approach to corneal reshaping.

Conclusion Although refractive surgery, as discussed here, is an elective procedure, its impact on people’s lives is profound. For many, the decision to undergo refractive surgery goes beyond convenience, marking an important step toward greater independence and an enhanced quality of life. With modern, precise, and reliable techniques, refractive surgery is transformative, offering a newfound sense of freedom to individuals who have long been dependent on contact lenses or glasses.

References available on request

Generic Product Launch Ferric Carboxymaltose Teva 50 mg iron/mL Dispersion for Injection/Infusion iron as ferric carboxymaltose

Indications Ferric Carboxymaltose Teva is indicated for the treatment of iron deficiency when: oral iron preparations are ineffective. oral iron preparations cannot be used. there is a clinical need to deliver iron rapidly.

The diagnosis of iron deficiency must be based on laboratory tests.

Ferric carboxymaltose Teva 50mg iron/ml dispersion for injection/infusion Abbreviated Prescribing Information.

Presentation: One ml of dispersion contains 50mg of iron (as ferric carboxymaltose). Indications: Ferric Carboxymaltose Teva is indicated for the treatment of iron deficiency when: oral iron preparations are ineffective; oral iron preparations cannot be used; there is a clinical need to deliver iron rapidly.

The diagnosis of iron deficiency must be based on laboratory tests. Dosage and administration: For intravenous administration only by injection, infusion or during a haemodialysis session. Ferric Carboxymaltose Teva should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Ferric Carboxymaltose Teva administration. Adults and Adolescents (aged 14 years and older): A single Ferric Carboxymaltose Teva administration should not exceed: 15mg iron/kg body weight (for administration by intravenous injection) or 20mg iron/kg body weight (for administration by intravenous infusion); 1000mg of iron (20ml Ferric Carboxymaltose Teva). Children and Adolescents (aged 1 to 13 years): A single Ferric Carboxymaltose Teva administration should not exceed: 15mg iron/kg body weight; 750mg of iron (15 mL Ferric Carboxymaltose Teva). Children below 1 year of age: Not recommended for use. Hepatic and Renal impairment: In patients with liver dysfunction, parenteral iron should only be administered after careful benefit/risk assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT). Careful monitoring of iron status is recommended to avoid iron overload. No safety data on haemodialysis-dependent chronic kidney disease patients receiving single doses of more than 200mg iron are available. Contraindications: Hypersensitivity to the active substance, to Ferric Carboxymaltose Teva or to any of the excipients. Known serious hypersensitivity to other parenteral iron products.

Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia. Evidence of iron overload or disturbances in the utilisation of iron. Precautions and warnings: Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction). The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy. There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis). If hypersensitivity reactions or signs of intolerance occur during

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

administration, the treatment must be stopped immediately. Facilities for cardiorespiratory resuscitation and equipment for handling acute anaphylactic reactions should be available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate. Symptomatic hypophosphataemia leading to osteomalacia and fractures requiring clinical intervention including surgery has been reported in the post marketing setting. Patients should be asked to seek medical advice if they experience worsening fatigue with myalgias or bone pain. Serum phosphate should be monitored in patients who receive multiple administrations at higher doses or long-term treatment, and those with existing risk factors for hypophosphataemia. In case of persisting hypophosphataemia, treatment with ferric carboxymaltose should be re-evaluated. Parenteral iron must be used with caution in case of acute or chronic infection, asthma, eczema or atopic allergies. It is recommended that the treatment with Ferric Carboxymaltose Teva is stopped in patients with ongoing bacteraemia. Therefore, in patients with chronic infection a benefit/risk evaluation has to be performed, taking into account the suppression of erythropoiesis. Caution should be exercised to avoid paravenous leakage when administering Ferric Carboxymaltose Teva Paravenous leakage of Ferric Carboxymaltose Teva at the administration site may lead to irritation of the skin and potentially long lasting brown discolouration at the site of administration. In case of paravenous leakage, the administration of Ferric Carboxymaltose Teva must be stopped immediately. Interactions: The absorption of oral iron is reduced when administered concomitantly with parenteral iron preparations. Therefore, if required, oral iron therapy should not be started for at least 5 days after the last administration of Ferric Carboxymaltose Teva. Pregnancy and lactation: A careful benefit/risk evaluation is required before use during pregnancy and Ferric Carboxymaltose Teva should not be used during pregnancy unless clearly necessary. Based on limited data on breast-feeding patients it is unlikely that ferric carboxymaltose represents a risk to the breast-fed child. Effects on ability to drive and use machines: Ferric Carboxymaltose Teva is unlikely to impair the ability to drive and use machines. Adverse reactions: Hypersensitivity, anaphylactic reactions, loss of consciousness, phlebitis, syncope, angioedema, hypophosphataemic osteomalacia. Common: Hypophosphataemia, headache, dizziness, flushing, hypertensions, nausea, injection/infusion site reactions. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: Administration of in quantities exceeding the amount needed to correct iron deficit at the time of administration may lead to accumulation of iron in storage sites eventually leading to haemosiderosis.

Monitoring of iron parameters such as serum ferritin and transferrin saturation (TSAT) may assist in recognising iron accumulation. If iron accumulation has occurred, treat according to standard medical practice, e.g. consider the use of an iron chelator. Legal category: POM. Marketing Authorisation Number: PA1986/124/001. Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands. Job Code: MED-IE-00082. Date of Preparation: July 2024

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

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

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

Prescription Only Medicine.

Date of Preparation: July 2024 | Job Code: GEN-IE-00092 Further information is available on request or in the SmPC. Product Information also available on the HPRA website.

fondaparinux sodium

The Only Selective & Synthetic Factor Xa Inhibitor Injectable Anticoagulant Licensed for Use in Adults1

Treatment of Acute Coronary Syndrome1

2.5 mg

Product subject to medical prescription which may not be renewed (A) Reference: 1. Arixtra® 2.5 mg/0.5 ml solution for injection, pre-filled syringe. Summary of Product Characteristics (SmPC). Available at: www.medicines.ie. Last accessed: August 2024.

ABBREVIATED PRESCRIBING INFORMATION Arixtra (fondaparinux sodium) 2.5 mg/0.5 ml solution for injection, pre-filled syringe Please refer to Summary of Product Characteristics (SmPC) before prescribing Indications, Dosage and Administration: Indications: Prevention of Venous Thromboembolic Events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. Prevention of Venous Thromboembolic Events (VTE) in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery. Prevention of Venous Thromboembolic Events (VTE) in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease.

Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in adults for whom urgent (<120 mins) invasive management (PCI) is not indicated. Treatment of ST segment elevation myocardial infarction (STEMI) in adults who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.

Dosage Patients undergoing major orthopaedic or abdominal surgery: The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by subcutaneous injection. The initial dose should be given 6 hours following surgical closure provided that haemostasis has been established. Treatment should be continued until the risk of venous thromboembolism has diminished, usually until the patient is ambulant, at least 5 to 9 days after surgery.

Medical patients who are at high risk for thromboembolic complications based on an individual risk assessment: The recommended dose of fondaparinux is 2.5 mg once daily administered by subcutaneous injection. A treatment duration of 6-14 days has been clinically studied in medical patients.

Treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI): The recommended dose of fondaparinux is 2.5 mg once daily, administered by subcutaneous injection. Treatment should be initiated as soon as possible following diagnosis and continued for up to a maximum of 8 days or until hospital discharge if that occurs earlier. If a patient is to undergo percutaneous coronary intervention (PCI), unfractionated heparin (UFH) as per standard practice should be administered during PCI, taking into account the

Job Code: IE-ARX-2024-00011 Date of Preparation: August 2024

patient’s potential risk of bleeding, including the time since the last dose of fondaparinux, the timing of restarting subcutaneous fondaparinux after sheath removal should be based on clinical judgment. In the pivotal UA/NSTEMI clinical trial, treatment with fondaparinux was restarted no earlier than 2 hours after sheath removal.

Treatment of ST segment elevation myocardial infarction (STEMI): The recommended dose of fondaparinux is 2.5 mg once daily. The first dose of fondaparinux is administered intravenously and subsequent doses are administered by subcutaneous injection. Treatment should be initiated as soon as possible following diagnosis and continued for up to a maximum of 8 days or until hospital discharge if that occurs earlier. If a patient is to undergo non-primary PCI, unfractionated heparin (UFH) as per standard practice should be administered during PCI, taking into account the patient’s potential risk of bleeding, including the time since the last dose of fondaparinux. The timing of restarting subcutaneous fondaparinux after sheath removal should be based on clinical judgment. In the pivotal STEMI clinical trial, treatment with fondaparinux was restarted no earlier than 3 hours after sheath removal.

Patients who are to undergo coronary artery bypass graft (CABG) surgery: In STEMI or UA/NSTEMI patients who are to undergo coronary artery bypass graft (CABG) surgery, fondaparinux where possible, should not be given during the 24 hours before surgery and may be restarted 48 hours post-operatively.

Treatment of superficial-vein thrombosis: The recommended dose of fondaparinux is 2.5 mg once daily, administered by subcutaneous injection.

Patients eligible for fondaparinux 2.5 mg treatment should have acute, symptomatic, isolated, spontaneous superficial-vein thrombosis of the lower limbs, at least 5 cm long and documented by ultrasonographic investigation or other objective methods. Treatment should be initiated as soon as possible following diagnosis and after exclusion of concomitant DVT or superficial-vein thrombosis within 3 cm from the sapheno-femoral junction. Treatment should be continued for a minimum of 30 days and up to a maximum of 45 days in patients at high risk of thromboembolic complications. Patients could be recommended to self-inject the product when they are judged willing and able to do so. Physicians should provide clear instructions for self-injection.

Patients who are to undergo surgery or other invasive procedures: In superficial vein thrombosis patients who are to undergo surgery or other invasive procedures, fondaparinux, where possible, should not be given during the 24 hours before surgery. Fondaparinux may be restarted at least 6 hours post-operatively provided haemostasis has been achieved.

Special populations: Prevention of VTE following Surgery: In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in patients ≥75 years, and/or with body weight <50 kg and/or with renal impairment with creatinine clearance ranging between 20 to 50 ml/min. The first fondaparinux administration should be given not earlier than 6 hours following surgical closure. The injection should not be given unless haemostasis has been established.

Renal impairment: Prophylaxis of VTE - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min. The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min. No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min). Treatment of UA/NSTEMI and STEMI - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min. No dosage reduction is required for patients with creatinine clearance >20 ml/min.

Treatment of superficial-vein thrombosis - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min. The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min. No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min).

Hepatic impairment: Prevention of VTE and Treatment of UA/NSTEMI and STEMI - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment. In patients with severe hepatic impairment, fondaparinux should be used with care as this patient group has not been studied. Treatment of superficial-vein thrombosis - The safety and efficacy of fondaparinux in patients with severe hepatic impairment has not been studied, therefore fondaparinux is not recommended for use in these patients.

Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age due to a lack of data on safety and efficacy.

Low body weight: Prevention of VTE and Treatment of UA/NSTEMI and STEMI Patients with body weight <50 kg are at increased risk of bleeding. Elimination of fondaparinux decreases with weight. Fondaparinux should be used with caution in these patients. Treatment of superficial-vein thrombosis - The safety and efficacy of fondaparinux in patients with body weight less than 50 kg has not been studied, therefore fondaparinux is not recommended for use in these patients.

anaesthesia or spinal puncture. The risk of these rare events may be higher with post-operative use of indwelling epidural catheters or the concomitant use of other medicinal products affecting haemostasis.

Administration Subcutaneous administration: Fondaparinux is administered by deep subcutaneous injection while the patient is lying down. Sites of administration should alternate between the left and the right anterolateral and left and right posterolateral abdominal wall. To avoid the loss of medicinal product when using the pre-filled syringe do not expel the air bubble from the syringe before the injection. The whole length of the needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; the skin fold should be held throughout the injection.

Severe hepatic impairment: Prevention of VTE and Treatment of UA/NSTEMI and STEMI - Dosing adjustment of fondaparinux is not necessary. However, the use of fondaparinux should be considered with caution because of an increased risk of bleeding due to a deficiency of coagulation factors in patients with severe hepatic impairment.

Intravenous administration (first dose in patients with STEMI only) Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50 ml) 0.9% saline minibag. To avoid the loss of medicinal product when using the pre-filled syringe do not expel the air bubble from the syringe before the injection. The intravenous tubing should be well flushed with saline after injection to ensure that all of the medicinal product is administered. If administered via a minibag, the infusion should be given over 1 to 2 minutes.

Heparin Induced Thrombocytopenia: Fondaparinux should be used with caution in patients with a history of HIT.

Presentation: Solution for injection Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Active clinically significant bleeding.

Acute bacterial endocarditis.

Severe renal impairment defined by creatinine clearance < 20 ml/min.

Warnings and precautions: Fondaparinux is intended for subcutaneous use only. Do not administer intramuscularly.

There is limited experience from treatment with fondaparinux in haemodynamically unstable patients and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter.

Haemorrhage: Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups. As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone recent surgery (<3 days) and only once surgical haemostasis has been established.

(For prevention of VTE) Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux. These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). When required, concomitant therapy with vitamin K antagonist should be administered. Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary.

For treatment of UA/NSTEMI, STEMI and superficial-vein thrombosis: Fondaparinux should be used with caution in patients who are being treated concomitantly with other agents that increase the risk of haemorrhage (such as GPIIb/IIIa inhibitors or thrombolytics).

PCI and risk of guiding catheter thrombus: In STEMI patients undergoing primary PCI, the use of fondaparinux prior to and during PCI is not recommended. Similarly, in UA/NSTEMI patients with life threatening conditions that require urgent revascularisation, the use of fondaparinux prior to and during PCI is not recommended. These are patients with refractory or recurrent angina associated with dynamic ST deviation, heart failure, life-threatening arrhythmias or haemodynamic instability.

In UA/NSTEMI and STEMI patients undergoing non-primary PCI: the use of fondaparinux as the sole anticoagulant during PCI is not recommended due to an increased risk of guiding catheter thrombus. Therefore adjunctive UFH should be used during non-primary PCI according to standard practice.

Patients with superficial-vein thrombosis: Presence of superficial-vein thrombosis greater than 3 cm from the sapheno-femoral junction should be confirmed and concomitant DVT should be excluded by compression ultrasound or objective methods prior to initiating treatment of fondaparinux.

Spinal/Epidural anaesthesia: In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in long-term or permanent paralysis cannot be excluded with the concurrent use of fondaparinux and spinal/epidural Job Code: IE-ARX-2024-00011 Date of Preparation: August 2024

Elderly patients: The elderly population is at increased risk of bleeding. As renal function is generally decreasing with age, elderly patients may show reduced elimination and increased exposure of fondaparinux. Fondaparinux should be used with caution in elderly patients.

Low body weight: Prevention of VTE and Treatment of UA/NSTEMI and STEMI - Patients with body weight <50 kg are at increased risk of bleeding. Fondaparinux should be used with caution at a daily dose of 5 mg in this population. Elimination of fondaparinux decreases with weight. Fondaparinux should be used with caution in these patients.

Treatment of superficial-vein thrombosis - Fondaparinux is not recommended for treatment of superficial-vein thrombosis in patients with body weight less than 50 kg.

Renal impairment: Fondaparinux is known to be mainly excreted by the kidney. Prophylaxis of VTE - Patients with creatinine clearance <50 ml/min are at increased risk of bleeding and VTE and should be treated with caution. For the treatment of UA/NSTEMI and STEMI- there are limited clinical data available on the use of fondaparinux 2.5 mg once daily in patients with creatinine between 20 and 30 ml/min.

Therefore, the physician should determine if the benefit of treatment outweighs the risk. For treatment of superficial-vein thrombosis - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min. The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min.

Treatment of superficial-vein thrombosis - Fondaparinux is not recommended for the treatment of superficial-vein thrombosis in these patients.

Latex Allergy: The needle shield of the pre-filled syringe may contain dry natural latex rubber that has the potential to cause allergic reactions in latex sensitive individuals.

Interactions with other medicinal products and other forms of interaction: Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage. In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux did not influence the anticoagulation monitoring (INR) activity of warfarin. Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux. At the 10 mg dose used in the interaction studies, fondaparinux did not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.

If follow-up treatment is to be initiated with heparin or LMWH, the first injection should, as a general rule, be given one day after the last fondaparinux injection.

If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be continued until the target INR value has been reached.

Fertility, pregnancy and lactation: Pregnancy: No clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development because of limited exposure. Fondaparinux should not be prescribed to pregnant women unless clearly necessary.

Breast-feeding: Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk. Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the child is however unlikely.

Fertility: There are no data available on the effect of fondaparinux on human fertility. Animal studies do not show any effect on fertility.

Undesirable effects: Serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/intracerebral and retroperitoneal bleedings). Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage.

Very common (≥1/10): None. Common (≥1/100, <1/10): anaemia, post-operative haemorrhage, uterovaginal haemorrhage, haemoptysis, haematuria, haematoma, gingival bleeding, purpura, epistaxis, gastrointestinal bleeding, hemarthrosis, ocular bleeding, bruise.

For details of uncommon, rare and very rarely reported adverse events and those of unknown frequency, see SmPC. Reporting of adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie. Adverse reactions/events should also be reported to the marketing authorisation holder at the email address: pv.ireland@viatris.com or phone 0044(0)8001218267.

Legal Category: Product subject to prescription which may not be renewed (A).

Marketing Authorisation Number: EU/1/02/206/003 Marketing Authorisation Holder: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland Full prescribing information available on request from: Viatris, Dublin 17.

Email: enquiry.ire@viatris.com.

Date of Revision of Abbreviated Prescribing Information: 27 Feb 2024 Reference Number: IE--AbPI-Arixtra-2.5mg-v003

fondaparinux sodium

18 ESMO 2024

From Practice-Changing Date to Future Innovation Dr Reebecca Dent, ESMO 2024 Chair

benefit from new options to treat this fatal condition going forward. “Prostate cancer is very common, so it is exciting to see research producing a multitude of therapies to help patients beyond castration resistance, including a novel combination of the androgen receptor antagonist enzalutamide with radium 223,4 combination immunotherapy,5 and several new compounds,6” said Dent.

The European Society for Medical Oncology (ESMO) held its annual congress recently at the Fira Barcelona Gran Via. The ESMO 2024 comprehensive educational and scientific program fostered exchange and debate on translational cancer science, presented groundbreaking data, and encouraged multidisciplinary discussions to improve patient treatment. It also provided updates on cancer prevention, screening, and research breakthroughs, analysed clinical perspectives, and enhanced understanding of novel diagnostics and treatments.

ESMO 2024 Scientific Chair Dr Rebecca Dent underlined the importance of the overall survival data to be presented from the KEYNOTE-522 study in this difficult-to-treat breast cancer subtype, as the therapy is not yet approved everywhere in the world.

Dent similarly highlighted that for bladder cancer, where treatment options were limited in the past, the positive phase III NIAGARA trial marks another milestone in a recent surge of research advances already reported at the ESMO Congress 2023.

In anal cancer, a disease usually diagnosed in the advanced stages and where rates of relapse on standard treatment with chemoradiotherapy are high, a combination of immunotherapy and chemo is opening up new, much-needed possibilities for patients.1 As ESMO President

Dr Andrés Cervantes explained: “POD1UM-303/InterAACT 2 is the first phase III randomised controlled trial not just of immunotherapy, but overall in this tumour type. Though uncommon in the developed world, anal cancer is more prevalent in low and middle-income countries and, alongside HPV vaccination as an effective means of prevention, this is an important step in treating a disease that is currently still managed with medicines developed 50 years ago.”

Important data will also be presented on the longterm outcomes of the first melanoma patients treated with immunotherapy, providing novel insights into its survival benefits and toxicities.2, 3 “The arrival of immune checkpoint inhibitors and combination therapies dramatically changed the situation for melanoma patients, who previously had few treatment options and poor life expectancy. Talking about 10-year survival outcomes is outstanding in and of itself, but as clinicians we also need to understand what happens to these patients over time to be able to better differentiate whom to give which treatment to based on the expected benefits,” Dent explained.

An expanding landscape of therapeutic agents With several phase III trials reporting positive results, patients with metastatic castrationresistant prostate cancer will

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

Research introducing antibodydrug conjugates (ADCs) is equally prolific, with over 100 agents currently under development and data to be presented at the ESMO Congress 2024 covering the entire spectrum of phase I,7, 8 phase II9 and phase III/IV trials.10, 11 “ADCs are a smart way of delivering chemotherapy as the antibodies it is bound to in a complex molecular structure deliver their payload directly inside the tumour cells they recognise, preserving healthy tissue and thus offering reduced toxicity alongside potentially higher antitumour activity,” said Cervantes.

An eye on the future of oncology While many research results presented over the next five days will change clinical practice in the short term, the ESMO Congress 2024 will also provide a perspective on the directions in which oncology will evolve in the future during a dedicated Presidential Symposium.

Cervantes highlighted artificial intelligence for its potential to be applied to medical images not just from radiology devices, but also from pathology slides,12 to capture information that the human eye cannot and eventually facilitate better diagnosis, treatment and follow-up.

The ESMO President took the opportunity to announce the launch of a new ESMO AI and Digital Oncology Congress in 2025. “ESMO has a responsibility to keep doctors updated on what is happening in these areas, which are going to transform the way we receive information about cancer and the way we make decisions in oncology,” he said, explaining the rationale for the new event.

Preventing burnout among the oncology workforce The ESMO Congress 2024 is also an important occasion on which to address current issues affecting the profession. Among these, ensuring the resilience and wellbeing of the cancer workforce in the face of increasing pressures from staff shortages and rising workloads will be the subject of a dedicated session. A vital message in this regard was conveyed in the recently published ESMO Resilience Task Force recommendations to manage psychosocial risks, optimise well-being, and reduce burnout in oncology, a proposal for multitiered, concerted action to support and retain oncologists in the field.

“Burnout is a situation in which a professional feels overwhelmed by their responsibilities and is no longer able to cope with the difficulties of performing their day-to-day activities, with possible knock-on effects on the individual’s mental health, such as anxiety, depression or insomnia,” said Cervantes. “We cannot afford to lose our workforce, so we must raise awareness and tackle burnout as the common problem that it has become.” An additional, qualitative analysis13 of the findings from the surveys on how oncologists can best be helped and supported in their mission to care for cancer patients will also be presented in Barcelona.

ESMO 2024 Press Officer Dr Angela Lamarca highlighted the holistic nature of the ESMO Congress in several respects: “We will see everything from the earliest preclinical data to phase III trials comparing new treatment regimens with our current practice, a multitude of different agents and technologies under development, emerging knowledge across a broad range of disease types beyond the most common cancers—and discussions around the health and wellbeing of not just patients, but also oncology professionals,” she said.

With a wealth of high-quality data selected from over 5,000 submitted abstracts, and 600 experts onsite to present and discuss the latest research results with 33,000 registered attendees, the ESMO Congress 2024 is starting as a record-breaking edition. “These unprecedented figures illustrate the strength and the global reach of this meeting in delivering new science to the oncology community,” Cervantes concluded.

References available on request

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Women’s Health Perinatal Mental Health

20

Perinatal Mental Health Written by Dr Catherine Hinds, Consultant Perinatal Psychiatrist, The National Maternity Hospital depression noted. SPMH services have faced substantial increasing demand since their inception, through increased awareness of perinatal mental illness, higher disease burden and also as the profile of the services has become more apparent.

Perinatal mental illness refers to new and recurrent mental illness that occurs during pregnancy and the first postnatal year. It includes all mental health conditions that may emerge or relapse during this time in a woman’s life. People immediately think of Postnatal Depression as the most common concern for new mothers, but Antenatal Depression is at least as common. Antenatal and Postnatal Anxiety are also both common.

Perinatal mental illness includes mental illness specific to mothers, such as Birth Trauma, and the uncommon cases of Puerperal Psychosis. But any condition can occur or relapse during the perinatal period, including PTSD, Eating Disorders, OCD, Personality Disorder, Schizophrenia and Bipolar Affective Disorder.

Perinatal Mental Illness can have a significant impact on those affected, impairing relationships, quality of life and physical health.

There is a substantial body of evidence demonstrating the risks of perinatal mental illness to both mothers and their infants. Perinatal mental illness is associated with a higher risk of pre-term birth, low birth weight, impaired bonding, and long-term emotional, cognitive and psychological problems for the child.

Perinatal Mental Illness is common. 20% of women experience diagnosable mental illness during pregnancy or the first year postpartum. This has been compounded in recent years, by the global impact of the Covid-19 pandemic. Studies in Ireland and the UK have highlighted the impact of the pandemic on women during the peripartum period with higher levels of Antenatal Anxiety and

Specialist Perinatal Mental Health services have been developed globally in the context of the recognition of the importance of prioritising women’s perinatal mental health. It is well recognised that the perinatal period provides a unique opportunity to improve perinatal mental health by early intervention and treatment as well as promotion of perinatal mental health and prevention of illness. There is a clear economic argument for specialist perinatal mental health services. UK research in 2014 estimated the financial cost of perinatal mental illness at £8.1billion, with 72% of this cost relating to adverse impact on the child rather than the parent.

Over the past five years, Specialist Perinatal Mental Health Services (SPMHS) have been established across Ireland to provide specialist care to all women, according to the Model of Care (2017). All six multidisciplinary hub services are now fully staffed, and offer a range of medical, psychological and other interventions to women in the major metropolitan areas.

These services have allowed for more varied psychological interventions to be offered, with more nuanced, individualised mental health care. The spoke services are based in smaller hospitals with lower birth rates in more rural areas. In these settings perinatal mental health midwives attached to the maternity units see women with mild-moderate illness. They are supported by the liaison psychiatry teams (where they exist) who provide the support for women with moderate to severe illness. In the absence of Liaison Psychiatry services, community adult mental health teams provide care.

Treatment and interventions Treatment options include talking therapy, lifestyle advice and

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

accessing support with baby care, and also psychotropic medication. Antidepressants are an effective treatment for anxiety and depression, and a range of other perinatal mental illness.

While there are some risks of using antidepressants in pregnancy and breastfeeding, medication may be an important part of treatment.

Treating perinatal mental illness effectively will have benefits for the mother and her baby in the short and long term.

practitioners, public health nurses, and community midwives. Some referrals to SPMHS services, which are mild-moderate in severity, are redirected to Primary Care where appropriate.

A large part of perinatal mental healthcare is provided in the Primary Care setting, by general

All care is delivered with a traumainformed approach. A range of evidence-based interventions

SPMHS offer assessment and case management of women suffering with perinatal mental illness. Perinatal Psychiatrists also offer preconception counselling to women with severe mental illness who are planning a pregnancy.

21

treatments and support services and a discussion about key family members that need to be involved.

Figure 1: Estimated number of women affected by perinatal mental illness in Ireland each year

Mother and Baby Unit

134 Postpartum Psychosis

Postpartum Psychosis is a severe mental illness that typically affects women in the weeks after giving birth, and causes symptoms such as confusion, delusions, paranoia and hallucinations

Rate: 2/1000 maternities

134 2,013 2,013

Chronic serious mental illness

Chronic serious mental illnesses are longstanding mental illness, such as bipolar disorder or schizophrenia, which may be more likely to develop, recur or deteriorate in the perinatal period.

Rate: 2/1000 maternities

Severe depressive illness

Severe depressive illness is the most serious forms of depression, where symptoms are severe and persistent, and significantly impair a woman’s ability to function normally.

Rate: 30/1000 maternities

Post traumatic stress disorder (PTSD) PTSD is an anxiety disorder caused by very stressful, frightening or distressing events, which may be relived through intrusive, recurrent recollections, flashbacks and nightmares.

Rate: 30/1000 maternities

to moderate depressive illness and 10,066 Mild anxiety states Mild-moderate depressive illness includes symptoms such as persistent sadness, fatigue and a loss of interest and enjoyment in activities. It often co-occurs with anxiety, which may be experienced as distress, uncontrollable worries, panic or obsessive thoughts.

Rate: 100-150/1000 maternities

20,133 Adjustment disorders and distress

Adjustment disorders and distress occur when a women is unable to adjust or cope with an event such as pregnancy, birth or becoming a parent. A woman with these conditions will exhibit a distress reaction that lasts longer, or is more excessive than would normally be expected, but does not significantly impair normal function.

Rate: 150-300/1000 maternities

Ireland desperately needs a specialist, in-patient unit for perinatal women with severe mental health problems who require acute inpatient mental health care. There is currently no inpatient provision for specialist perinatal mental healthcare in the whole of Ireland. The gold standard for inpatient care for postnatal women up to the first year of the baby’s life, is to be admitted to a specialist mother and baby unit, staffed by specialist perinatal mental health staff, providing appropriate care to babies, and offering the full range of therapeutic services.

Unfortunately, despite being a key recommendation in the Model of Care (2017), no such unit has been built to date with plans at a very preliminary stage of development.

Mother and Baby Units (MBUs) have been established in many European countries, Australia, New Zealand, Sri Lanka, India and the United States. Women living in countries or regions without access to an MBU have to be admitted to general psychiatric wards and separated from their babies. This is distressing for women, impairs bonding and attachment with their babies at a crucial stage in the baby’s development, and makes it more likely that formal care arrangements will have to made for the baby where a partner is not available. When mothers and babies are not separated, and positive relationships can continue, mothers tend to retain and enhance their role as primary care-giver.

An MBU service needs to be established in Ireland as a priority.

Given such a project will take time, there is a need for interim training of adult inpatient psychiatrists in specialist management of perinatal mental illness.

What next?

Rate is estimated back on average number of births for the years 2012-2016 There may be some women who experience more than one of these conditions.

Adapted for the Irish population from Prevention in Mind NSPCC, UK 2013 and JCP-MH 2012

are offered, including attachment therapy, CBT, birth trauma support, group therapy for antenatal and postnatal depression and anxiety, and other specialist interventions.

Women are assessed with their babies, to assess bonding and attachment, and support them both as a mother-infant dyad. We

also support partners and fathers, as part of the family unit.

Women with severe or complex mental illness are offered prebirth planning meetings, where a Perinatal Mental Health Care Plan is produced. This plan allows a woman and her carers

to discuss her early warning signs of relapse, treatment preferences, and breastfeeding preferences. It provides guidance on mental health support during the pregnancy, birth and postnatal period, including the identification of relevant healthcare clinicians, the range of appropriate

Watch this space for a new revision of the Model of Care for Perinatal Mental Health Services in Ireland. The revision will lay out plans to expand SPMH services to meet the increasing demands, and in particular to provide multidisciplinary teams in the spoke areas to provide equity of access to all women in Ireland.

The campaign for the MBU is gaining momentum, to provide this much needed inpatient service for women and babies in Ireland.

HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

Women’s Health Maternal Medicine

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Maternal Medicine; Where Teamwork Makes the Dream Work Written by Dr. Siobhán Corcoran, Consultant Obstetrician & Gynaecologist, The National Maternity Hospital The Maternal Medicine Team at The National Maternity Hospital.

Left to Right: Professor Mary Higgins, Consultant Obstetrician & Gynaecologist; Dr. Siobhán Corcoran, Consultant Obstetrician & Gynaecologist; Maternal Medicine Pharmacist, Benedetta Soldati; SpR Dr. Rachel O’Keefe; Maternal Medicine Midwives, Ms Shauna O’Callaghan, and Ms Celine O’Brien

We are all familiar with older generations saying “It wasn’t like that in my day!”. Indeed, when it comes to Obstetrics, never a truer word was said.

Women are now embarking on childbearing later in life due to a variety of socio-economic factors. The Irish CSO figures show that the average age at first childbirth in 1980 was 24.9 years.

In 2018 this had risen to 31.1 years. The National Maternity Hospital’s Annual Report in 2022 demonstrated that 11.6% of all births in that year were to women aged over 40. Older mothers are more likely to have comorbidities than younger counterparts. Added to this, developments in medical and surgical therapies over the last 20-30 years have meant that more women with complex

medical and surgical conditions in early life are now surviving & reaching childbearing years. All of these facts, coupled with a frameshift in societal expectation of what is now possible, has led to the development of Maternal Medicine as a distinct subspecialty of Obstetrics.

There are two key questions which the Maternal Medicine team must consider when meeting a woman with a complex medical condition who is now pregnant. How does the disease affect the pregnancy?

And how does the pregnancy affect the disease? For example, the woman with epilepsy will have an increased risk of seizures in pregnancy due to the physiological plasma expansion and lowered serum levels of antiepileptic drugs that occurs in pregnancy

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and also the effects of pregnancy hormones on lowering the seizure threshold. Nausea and vomiting in pregnancy can affect medication compliance and sleep deprivation in late pregnancy can be a trigger for seizure activity also.

Medication safety will be of critical importance to these women.

Understanding the risk/benefit profile of the various anti-epileptic drugs will help get the best outcome for mother and baby.

A second example of this could be a woman with active Lupus and hypertension. She will have a significant risk of pre-eclampsia, fetal growth restriction and iatrogenic preterm delivery due to her disease and so a care plan will need to be devised to mitigate against and offer surveillance for this. In turn, should she develop severe pre-eclampsia this may cause her renal function to deteriorate in the long term also and so the pregnancy may impact on her disease trajectory.

Medication safety and optimisation will be a critical focus of the team here too.

Maternal Medicine is a team sport!

Owing to the highly complex nature of the care provided at the Maternal Medicine Clinic, it is necessary to have a wide range of health care professionals working together on any given pregnancy.

Obstetricians, Specialist Midwives and Advanced Nurse Practitioners, Maternal Medicine Pharmacists,

Anaesthetics, Renal, Haematology, GI, Endocrinology and Neurology physicians among many others will frequent input to the care of any one women.

So what makes a Maternal Medicine team effective? The most critical skill in Maternal Medicine is good communication.

Pregnancy is dynamic and deteriorations or changes in a patient’s status can happen quickly. Added to this, the unpredictability of obstetrics means that timely and effective communication between members is essential. The MultiDisciplinary Team (MDT) meeting is the lynchpin of the service where members are updated weekly and careplans are made. Shared decision making with the patient is an important part of any effective service and of course the Maternal Medicine team has a critical role in clinical teaching and improving the care of women with complex medical needs. Flexibility in delivery planning means that the Maternal Medicine team will often have developed 2 or 3 different delivery plans with one woman to account for the unpredictability of childbirth.

Increasingly, Preconceptual Counselling has come to the fore in recent years as an opportunity and a challenge in Maternal Medicine. Pregnancy outcomes in many conditions are improved following preconceptual planning.

Medications can be optimised, potential risks & complications can be explored and a pregnancy care plan can be devised. In very rare situations, pregnancy may not be advised due to serious risks to the health of the mother and alternatives can be explored.

Maternal Medicine as a subspecialty is both challenging and incredibly rewarding due to the variety and the complexity each day brings. Seeing a mother and her baby safely through pregnancy and supporting them through any complications means that no two days are the same.

Working in a diverse and highly effective team with this shared goal is hugely fulfilling. The future is bright here.

Women’s Health BRCA Gene

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An Overview of BRCA – BReast CAncer Gene What is BRCA?

Genetic test for BRCA

BRCA stands for BReast CAncer gene. Everyone has BRCA1 and BRCA2 genes. They are important genes that stop the cells in our body from growing and dividing out of control. By doing this, the genes help to protect us from getting cancer. They are often referred to as tumour suppressor genes. Everyone has two copies of each of the BRCA1 and BRCA2 genes—one copy inherited from each parent.

If you are worried about a pattern of cancer in your family, talk to your GP. If your GP thinks that there may be an inherited cause for cancer, based on your family history, they will refer you to a genetics clinic. The clinic will do a detailed review of your family history to find your level of risk and whether you and or your close blood relatives should be referred for genetic testing. The most useful way of carrying out genetic testing is to start with someone who had a diagnosis of breast or ovarian cancer. This is called a diagnostic genetic test and involves a blood test.

Written by Bernie Carter, Assistant Director of Nursing, Marie Keating Foundation

females with a BRCA1 or BRCA2 fault. Most resent research shows that:

Both men and women can inherit o 65 - 79% of females who a fault in their BRCA1 or BRCA2 have inherited a faulty BRCA1 genes. A fault in the BRCA1 or gene and BRCA2 gene means that the cells o 61 - 77% of females who can grow out of control and this have inherited a faulty BRCA2 If a BRCA1 or BRCA2 alteration can lead to cancer developing.2 will develop breast iscancer alteration or BRCA2 gene:breast • have Risks found with in thean family, it may in the BRCA1gene If you onefor of developing the faulty BRCA cancer by the age develop of 805 be possible to offer genetic On average, genes, there o is a 50% (1 in 2) between 11 – 14% of females without a genetic alteration will testing to other members for females chance you will pass thiscancer on to in their o A large breast life time.

Thisfamily risk increases withprospective a BRCA1 orcohort including those unaffected by any children you have and a 50% study of 6036 BRCA1 and BRCA2 fault.

Most resent research shows that: cancer, to check if they share this (1 in 2) chance that each of your 3820 BRCA2 female carriers alteration.

Thishave is called a o 65 - 79%gene of females who inherited a faulty(5046 BRCA1 gene and siblings also has it.9 unaffected and 4810 8 predictive genetic test. with breast or ovarian o 61 77% of females who have inherited a faulty BRCA2 gene will cancer • Most cancers are not linked to or both at baseline) showed will need a GP referral developYou breast cancer by the agefor of 80 (5) inherited faulty genes. Between that breast cancer incidences public or private testing 5 and 10 in every cancers (5 o 100 A large prospective cohort studygenetic of 6036 BRCA1 and 3820 BRCA2rapidly femaleincarriers increased early in Ireland. to 10%) diagnosed are linked to adulthood until ages 30 to (5046 or both at baseline) 2 unaffected and 4810 with breast or ovarian cancer an inherited faulty gene.

What is the risk for breast and BRCA1 and showed that breast cancer incidences increased rapidly40 in years early for adulthood until ovarian cancer with BRCA1 until ages 40 to 50 years for • A fault in the BRCA1 or the ages 30 to 40 years for BRCA1 and until ages 40 to 50 years for BRCA2 carriers or BRCA2?

BRCA2 carriers BRCA2 gene can lead to an o female This study increased risk for and showed that the cumulative risk for developing breast cancer in the The risks of developing breast o This study showed that the male breast cancer,opposite ovarian breast (contralateral breast cancer) 20 years after breast cancer and ovarian cancer are markedly cumulative risk for developing cancer (including fallopian increased in people who inherit a for BRCA2 breast diagnosis (5) cancer in the opposite tube and primary peritoneal is 35%-45% for BRCA1 and 20%-33% fault in their BRCA1 or BRCA2.2 breast (contralateral breast cancers), and to a lesser extent cancer) 20 years after breast other such as prostate • Risks developing breast in the BRCA1 or BRCA2 gene: • cancers Risks for developing ovarian cancerforwith an alteration cancer diagnosis is 35%-45% cancer, pancreatic cancer, cancer with an alteration in the for BRCA1will anddevelop 20%-33% o On average, between 1-2% of females without a genetic alteration 10 and melanoma.

BRCA1 or BRCA2 gene: for BRCA25 ovarian cancer in their life time. This risk increases for females with a BRCA1 or People who have inherited a o On average, between 11 – Managing your cancer risk with Most resent research shows that:a harmful change in BRCA2 BRCA1 fault. or 14% of females without a BRCA1 or BRCA2 Alteration: o 36cancer - 53% of females who have inherited a faulty BRCA1 gene and BRCA2 also tend to develop genetic alteration will develop at a younger age than people breastwho cancer their life a faulty Individuals who will havedevelop inherited o 11who - 25% of females havein inherited BRCA2 gene a harmful change in BRCA1 or do not have such a variant.2 time. This risk increases for

ovarian cancer by the age of 80 (5)

Risk of Breast and Ovarian Cancer in female carriers with a BRCA1 or BRCA2 alteration (Kuchenbaecker 2017) (5) Cancer Type

General Population (No Genetic Fault)

Individuals with BRCA Fault BRCA1

BRCA2

Breast

11 – 14%

65 - 79%

61 - 77%

Ovarian

1-2%

36 - 53%

11 - 25%

Managing your cancer risk with a BRCA1 or BRCA2 Alteration:

BRCA2 have several options for reducing their risk of cancer. These include enhanced screening, taking medication to reduce their breast cancer risk and riskreducing surgery (sometimes referred to as prophylactic or preventive surgery).7 • Enhanced screening: Individuals who are confirmed as having a BRCA1 or BRCA2 gene alteration are typically offered breast screening from the age of 308 o Most women will be offered regular mammograms (X-rays of the breast) and a breast examination by a specialist clinician. o Sometimes the clinician will include ultrasound scans, or Magnetic Resonance Imaging (MRI) of the breast because breast screening with mammogram alone is difficult in younger women who tend to have denser breast tissue.

Dense breast tissue (nonfatty tissue) looks solid and white on a mammogram. You cannot see through it. This makes the mammogram more difficult to read12 o There is no known effective ovarian cancer screening methods. You may be offered an internal (transvaginal) ultrasound scan every year and a blood test called CA125. This is the only method available at present, but these procedures are not proven to be reliable in picking up early ovarian cancer.

HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

Individuals who have inherited a harmful change in BRCA1 or BRCA2 have several options for

Women’s Health BRCA Gene

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• Risk-reducing medications (sometimes called chemoprevention) o Chemoprevention describes drugs that are used to reduce the risk of cancer developing. This is different from chemotherapy which describes drugs that are used in the treatment of cancer o Two drugs have been recommended by the National Institute for Health and Care Excellence (NICE) – Tamoxifen and Raloxifene.

Both these drugs have antioestrogen properties o Women with a BRCA2 gene alteration who are considering chemoprevention should have a discussion with their doctor regarding the potential benefits and side effects.

Chemoprevention is not recommended for women with a BRCA1 gene alteration because most women with a BRCA1 gene alteration develop a breast tumour that is not oestrogen sensitive, and there is no evidence that Tamoxifen or Raloxifene would reduce their risk of breast cancer11

Risk-reducing surgeries (sometimes referred to as prophylactic or preventive surgery • Risk-reducing, or prophylactic, surgery involves removing as much of the “at-risk” tissue— that is, the tissue where cancer may develop—as possible11 Managing your risk of breast cancer: • Women may choose to have both breasts removed (bilateral risk-reducing mastectomy) to reduce their risk of breast cancer3

• It is a personal choice to have reconstruction or not and it may not be suitable for all women.

Some people choose not to have breast reconstruction • There are several types of breast reconstruction. Some techniques use implants.

Others use tissue from your body (tissue from your belly (abdomen), back, or thigh) to recreate the breast • Your surgeon and breast care nurse will talk to you about all your options. They will explain the advantages and disadvantages to help you make the right decision for you13

• Women who have risk-reducing mastectomies reduce their risk of developing breast cancer to less than 5% over their lifetime, which is less than the risk in the general population11

Managing your risk of ovarian cancer:

• Breast Reconstruction or Not: Breast reconstruction is surgery to make a new breast after removal of the breast, part of the breast or both breast (double mastectomy)

• This surgery is carried out to reduce the risk of developing ovarian or fallopian tube cancer and lowers the risk to less than 5%

• The aim is to make a breast of similar size and shape to your original breast but they won't be identical

• Surgery to remove the ovaries and fallopian tubes is called bilateral risk-reducing salpingo-oophorectomy13

• There are studies looking at whether it is possible to remove the fallopian tubes first, and delay removing the ovaries until a later date, to prevent ovarian cancer11

o One of those studies is called PROTECTOR study but it is not open to people in the Republic of Ireland. It includes 42 hospitals across England, Wales, Scotland and Northern Ireland and recruitment is due to close in December 202414 Be Breast Aware and know the signs and symptoms for Ovarian Cancer After discussion with your doctor, you may decide that none of the above options are appropriate for you at this time. It may be that you are younger than the recommended age for surgery, or it may be that you wish to stay fertile as you have not completed your family. It is important to make the decision that is right for you, and this decision can be discussed with your doctor, nurse, or genetic counsellor at any time.11 It is important to be ‘Breast Aware’ as part of your surveillance and to know the signs and symptoms of ovarian cancer. Please visit the Marie Keating Foundation website www.mariekeating.ie for further information and to view a video on how to check your breasts for changes.

References available on request

Women’s Health News

New Research on Women’s Heart Health Broadcaster Maura Derrane is pictured with consultant cardiologist and Medical Director of the Irish Heart Foundation, Dr Angie Brown

It was commissioned by the Irish Heart Foundation for its ‘Her Heart Matters’ campaign, running throughout September.

Only half of women say they recognise the symptoms of heart disease and stroke, while 28% have never had a heart health check, new research shows.

The national Ipsos survey also reveals 70% of the public believe females are more likely to contract breast cancer than both heart disease and stroke - despite statistics showing they are six times more likely to die from both conditions.

“The perception is quite different to the reality that one in four women dies from heart disease and stroke,” said Dr Angie Brown, Consultant Cardiologist and Medical Director with the Irish Heart Foundation.

“Women are six times more likely to die from heart disease and stroke than they are from breast cancer so a significant gap in awareness of the symptoms has opened up.”

The research, conducted among 1,056 respondents, shows that

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a third of people in Ireland (33%) believe women are at lower risk of heart disease and stroke than men, 41% believe the risk is the same and 16% think women are more at risk.

And when women only were asked, just 50% said they recognised the symptoms of heart disease and stroke, 23% did not and 27% neither agreed nor disagreed. The 50% figure compares to 64% of women who said they recognise breast cancer symptoms.

The Ipsos poll also showed that 41% of women have spoken to a healthcare professional about their heart health within the last year – but 28% have never done so.

“We are encouraging all women, but especially those in their mid50s and beyond, to have their heart health checked, particularly if they experience chest or back pain, difficulty breathing, dizziness or extreme fatigue – please don’t

put it on the long finger,” said Dr Brown.

“Society as a whole needs to confront this embedded myth that heart disease is a male disease; it is still not seen as a disease that affects women to the degree that it does.

“Women need to seek help earlier if they have any suspicion something might be wrong, advocate for themselves, recognise the signs and potentially save their own lives.”

Sarah O'Brien, HSE, Healthy Eating & Active Living Programme, Health & Wellbeing, said regular physical activity, quitting smoking, eating healthier and limiting alcohol use are among the crucial steps in helping to prevent up to 80% of premature cardiovascular disease and stroke cases.

“Small steps now can result in substantial health benefits in the future,” she said.

Women’s Health Pain

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The Role of the Microbiome-Gut Brain Axis in Women’s Health and Pain While chronic pain affects approximately 20% of adults, women and girls are disproportionally affected. Despite this, traditionally most of the pain research in the pre-clinical setting has been conducted solely in male animals. More recently, with the inclusion of females in animal research it has been revealed that sex differences exist in many of the fundamental mechanisms underlying pain. Human studies have also identified differences in the neural circuitry involved in pain processing between the sexes using neuroimaging (Osborne and Davis, 2022). The gut microbiome is defined as the ecosystem of commensal, symbiotic, and pathogenic microorganisms (Armet et al., 2022) and is different between the sexes (Caputi et al., 2022). This community of microorganisms has been associated with both health and disease states and through a series of pathways, referred to as the microbiome-gut-brain axis, can impact the central nervous system including pain processing.

The microbiome-gut-brain axis is composed of neuronal, immune, and endocrine signalling pathways allowing bi-directional interactions between the gastrointestinal tract and the central nervous system (Cryan et al., 2019).

The microbiome is capable of producing neurotransmitters as well as microbial-derived neuroactive products such as short-chain fatty acids, which allow microbes to directly impact the nervous systems. The gut microbiome is also directly involved in the production and metabolism of female hormones such as oestrogen, progesterone and luteinizing hormone (Diviccaro et al., 2021). The physiological levels of these hormones vary across the menstrual cycle and menstruation itself has various biological, social and psychological aspects associated with it (Jain et al., 2023) with the period preceding menstruation being linked to several nervous system and peripheral symptoms including anxiety, fatigue, decreased concentration, and abdominal bloating (Jain et al.,

2023). The gut microbiome has been noted to be altered in certain female-specific conditions linked with hormonal imbalance such as polycystic ovaries, endometriosis and menopause (Siddiqui et al., 2022) with a specific community of gut bacteria, referred to as the estrobolome, being capable of metabolising oestrogens and preventing their excretion.

The association between the gut microbiome and visceral pain as noted in irritable bowel syndrome has been extensively studied and verified in many cases (Moloney et al., 2016). In more recent times the gut microbiome has been proposed as being used to predict somatic pain conditions such as post-operative pain (Masaud et al., 2024). Furthermore, certain microbes are associated with female-specific pain conditions and those that present more frequently in women such as postoperative pain, fibromyalgia and endometriosis. The interaction of the gut microbiome and female hormones as well as the potential links to pain syndromes in women provides potential therapeutic opportunities such as microbiomemodulating interventions such as diet changes particularly increasing fibre and prebiotic foods that enhance microbes associated with anti-inflammatory properties and anti-nociceptive properties. Other potential interventions include synbiotics where both prebiotics and probiotics (health-promoting bacteria) are administered together to optimise colonisation and efficacy. While fecal microbiota transplantation has been used to define the role of the microbiome in pain (Lucarini et al., 2022) there is still a long road to develop it as a therapeutic for pain.

Given the potential of the microbiome in healthcare for women, there is a real need to conduct further research into sexspecific therapeutic interventions that alleviate painful conditions in women. This research will hopefully shape the future of women's health and improve outcomes for women's health and pain management.

Authors: Dr Siobhain O'Mahony and Dr Mariarosaria Cuozzo, Department of Anatomy and Neuroscience, APC Microbiome Ireland, University College Cork, Ireland

References • Osborne NR, Davis KD. Sex and gender differences in pain. Int Rev Neurobiol 2022:164:277-307.

• Armet AM, Deehan EC, O'Sullivan AF, Mota JF, Field CJ, Prado CM, Lucey AJ, Walter J. Rethinking healthy eating in light of the gut microbiome. Cell Host Microbe.

2022 Jun 8;30(6):764-785.

• Caputi V, Bastiaanssen TFS, Peterson V, Sajjad J, Murphy A, Stanton C, McNamara B, Shorten GD, Cryan JF, O'Mahony SM. Sex, pain, and the microbiome: The relationship between baseline gut microbiota composition, gender and somatic pain in healthy individuals. Brain Behav Immun. 2022 Aug;104:191-204.

• Cryan JF, O’Riordan KJ, Cowan CSM, Sandhu KV, Bastiaanssen TFS, Boehme M, Codagnone MG, Cussotto S, Fulling C, Golubeva AV, et al.

The Microbiota-Gut-Brain Axis.

Physiol. Rev. 2019;99:1877– 2013.

• Diviccaro S, Caputi V, Cioffi L, Giatti S, Lyte, Caruso D, O’Mahony SM, Cosimo Melcangi R. Exploring the Impact of the Microbiome on Neuroactive Steroid Levels in Germ-Free Animals. Int J Mol Sci. 2021 Nov; 22(22): 12551.

• Jain P, Chauhan AK, Singh K, Garg R, Jain N, Singh R. Correlation of perceived stress with monthly cyclical changes in the female body. J Family Med Prim Care. 2023 Nov; 12(11): 2927–2933.

• Siddiqui R, Makhlouf Z, Alharbi AM, Alfahemi, Khan NA. The Gut Microbiome and Female Health. Biology (Basel). 2022 Nov; 11(11): 1683.

• Moloney RD, Johnson AC, O'Mahony SM, Dinan TG, Greenwood-Van Meerveld B, Cryan JF. Stress and the Microbiota-Gut-Brain Axis in Visceral Pain: Relevance to Irritable Bowel Syndrome.

CNS Neurosci Ther. 2016 Feb;22(2):102-17.

• Masaud K, Collins JM, Rubio RC, Corrigan M, Cotter PD, O'Brien N, Bluett R, Jimenez CK, O'Mahony SM, Shorten GD. The gut microbiota in persistent post-operative pain following breast cancer surgery. Sci Rep. 2024 May 30;14(1):12401.

• Lucarini E, Di Pilato V, Parisio C, Micheli L, Toti A, Pacini A, Bartolucci G, Baldi S, Niccolai E, Amedei A, Rossolini GM, Nicoletti C, Cryan JF, O'Mahony SM, Ghelardini C, Di Cesare Mannelli L. Visceral sensitivity modulation by faecal microbiota transplantation: the active role of gut bacteria in pain persistence.

Pain. 2022 May 1;163(5):861-877.

HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

Women’s Health PCO Syndrome

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Polycystic Ovary Syndrome Written by Dr Rachel Byrne and Dr Niamh Phelan. Department of Endocrinology, St James’s Hospital, Dublin stimulating hormone (FSH) leads to impaired folliculogenesis, ovulatory dysfunction and increased ovarian androgen synthesis. This results in a vicious cycle as androgen excess further exacerbates abnormal GnRH pulsation. Insulin resistance enhances ovarian androgen production from theca cells and inhibits hepatic sex hormone binding globulins (SHBG) production thereby increasing circulating free androgens.

Clinical manifestations Dr Rachel Byrne

Dr Niamh Phelan

Introduction

descent. It is a complex condition with endocrine, reproductive and metabolic health implications.

Polycystic ovary syndrome (PCOS) is the most common endocrinological condition seen in women of reproductive age affecting 8-13% of women in this cohort. In Ireland it is reported to affect 128 in 100’000 women, but a higher incidence is seen in women of eastern European and Asian

Figure one: Pathogenesis of PCOS. Image source: Miyuki Harada.

Pathophysiology of polycystic ovary syndrome revisited: Current understanding and perspectives regarding future research. 2022.

Pathogenesis The cause of PCOS is not fully understood, but is thought to be a multifactorial relationship between genetic predispositions, lifestyle and environmental factors.

A complex interplay between insulin resistance and androgen excess appears to be a key driver in the pathogenesis of PCOS. Abnormalities in gonadotrophin releasing hormone (GnRH) pulsation and gonadotrophin secretion with raised luteinising hormone (LH) compared to follicle

PCOS can have a varied clinical presentation. It most often presents in the teenage years/early to mid20s but many women will not seek medical advice for many years so it is not unusual to diagnose in women in their 30’s. The most common symptoms are menstrual irregularity with oligomenorrhea/ amenorrhoea but some women have polymenorrhoea. Features of androgen excess including acne, hirsutism and androgenic alopecia are also common presenting complaints. For some women fertility issues may be the initial presentation. Women with PCOS may also have secondary metabolic effects of PCOS including obesity, diabetes, hyperlipidaemia or obstructive sleep apnoea. There are also significant psychological

impacts from PCOS, particularly around fertility, obesity and overall body image.

Diagnosis There are a number of diagnostic criteria for PCOS, but the most widely accepted is the Rotterdam criteria. This criterion requires at least two of the three following features for diagnosis: 1.

Biochemical or clinical features of hyperandrogenism 2. Ovulatory dysfunction 3. Polycystic ovaries on ultrasound with exclusion of other potential causes. The most important conditions to exclude are late-onset (non-classic) congenital adrenal hyperplasia (CAH), androgen secreting tumours, Cushing’s syndrome, hyperprolactinaemia and thyroid disorders. A thorough history, clinical examination and initial laboratory investigations outlined in Table 1 will guide further investigations if needed.

Table 1: Recommended investigations for diagnosis of PCOS and for exclusion of alternate causes Initial Laboratory investigations • LH, FSH and oestradiol • Androgens: Testosterone, Androstenedione, DHEAS • Prolactin • Thyroid function tests • 17 hydroxyprogesterone (to outrule CAH) Further tests if indicated • Dexamethasone suppression test (to outrule Cushing’s) • Transvaginal ultrasound/CT adrenals (to exclude androgen secreting tumour) The recent 2023 international consensus guidelines suggest the stepwise approach outlined in figure 2 for diagnosis. Ovulatory dysfunction is characterised by irregular menstruation with cycles <21 or >35 days apart or <8 menses a year in women who are at least 3 years post menarche.

For adolescents between 1-3 years post menarche, cycles <21 or >45 days are considered irregular. It is important to note that pelvic ultrasound is not required for the majority of patients in order to make a diagnosis of PCOS.

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Figure two: Diagnostic algorithm in PCOS. Image source: Recommendations From the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome

Polycystic ovarian morphology is defined as ≥20 follicles per ovary in either ovary and/or ≥10 cm3 ovarian volume based on transvaginal ultrasonography.

However, 20-40% of normal healthy women may have polycystic ovarian morphology (PCOM) on ultrasound but do not have PCOS. Management Treatment is aimed at tackling the varying symptoms of PCOS and these may change throughout a patient’s lifetime. However, a particular continual focus should be to promote a heathy lifestyle to prevent weight gain and metabolic complications, improve fertility potential and reduce pregnancy complications.

Metabolic Health Lifestyle factors should firstly be addressed with the promotion of healthy diet and exercise.

Research has shown that a modest weight loss of up to 5% of body weight improves insulin sensitivity and reduces hirsutism.

It can also lead to recovery of a normal menstrual cycle and restoration of fertility. Weight loss is therefore a key initial management of PCOS. This is best approached by linking with dieticians and exercise programs.

Consideration can also be given to the addition of medications such as glucagon-like peptide-1 (GLP1) agonist to aid weight loss.

Unfortunately, these medications must be self-funded in Ireland when used for obesity and ongoing supply issues pose a challenge. For women seeking fertility, GLP1 agonist must be stopped at least 8 weeks prior to conception as the safety of these agents in pregnancy is unknown.

In more difficult cases, surgical options for weight loss can also be explored.

All women with PCOS should be considered as at increased risk for cardiovascular disease and should have assessment of cardiovascular risk factors including blood pressure, lipids and screening for diabetes regardless of age and BMI. Obstructive sleep apnoea is also more common in women with PCOS and again can occur in women with normal BMI. Irregular menses In women with PCOS who are not seeking fertility, it is important to manage amenorrhoea/ very infrequent menses due to the risk of endometrial hyperplasia.

Women with PCOS are five times more likely to develop endometrial carcinoma because of endometrial hyperplasia which can occur due to chronic exposure to oestrogen which is unopposed by progesterone in women with infrequent menses. To reduce this risk, it is recommended to ensure women with PCOS have a menstrual bleed at least once every three months. Strategies to achieve this include weight loss, hormonal contraceptives, regular progesterone therapy or hormonal intrauterine device (IUD).

Hormonal contraceptives are generally considered first line for regulation of the menstrual cycle.

Combined oral contraceptive pills (COCP) also help to manage symptoms of androgen excess in a number of ways. Firstly, the progesterone component inhibits LH and in turn reduces ovarian androgen production. The oestrogen component increases SHBG levels and therefore reduces free androgen concentrations.

However, many women may not be suitable for COCP due to risk of thromboembolic events or be intolerant, so the other options include the progesterone only pill or insertion of a hormonal IUD. Hormonal IUDs contain progesterone which maintains a

thin endometrial lining and since they are an effective contraceptive, they can be used in conjunction with antiandrogens.

should be offered combined oral contraceptives and antiandrogens as targets for the underlying hyperandrogenism.

Androgenic features

Metformin and inositol

Androgenic features of PCOS (acne, hirsutism and androgenic alopecia) respond to COCPs which are usually the first line agent of choice. However, another option in those not suitable for COCP, those intolerant or where they have proved ineffective is to add an anti-androgen such as spironolactone, provided effective contraception is in place.

Others antiandrogens such as cyproterone acetate or finasteride could also be considered but have a more deleterious side effect profile. These inhibit the binding of testosterone to the androgen receptor, thus reducing the features of hirsutism and acne.

The recommended starting regime is Spironolactone 25mg once a day increasing up to 100mg once a day.

The use of metformin in PCOS is controversial with many conflicting studies published around its long-term benefits.

Metformin undoubtedly reduces insulin resistance and has been shown to reduce visceral fat and overall body weight, however these effects are only significant when used in conjunction with lifestyle modifications.

Metformin is also reported to improve ovulatory function, thus aiding fertility, however when compared to ovulation induction with clomiphene/ letrozole or gonadotrophins, metformin alone is inferior. Overall, there seems to be some benefit in the addition of metformin but only in tandem with other targeted therapies and lifestyle optimisation. Inositol supplementation could also be considered in PCOS. Early evidence has shown it can help tackle the metabolic syndrome, however there is limited evidence to suggest it helps with fertility, hyperandrogenism or obesity. It is therefore not recommended ahead of metformin but may be considered in addition to or when metformin is poorly tolerated due to gastrointestinal side effects.

There are a number of options for mechanical removal of troublesome hair growth. These include shaving, waxing and electrolysis. Laser therapy is another option and often proves superior due its long-term impact.

Topical elfornithine 11.5% which targets the hair follicle and slows hair growth may also be beneficial particularly if used in conjunction with mechanical removal. Patients should also be warned this can result in irritation of the skin and can take up to 8 weeks before any benefits are noted.

Treatment for acne should not be forgotten nor delayed during the holistic approach to PCOS. Delay in treatment can lead to unduly emotional and psychological distress as well as increase the risk of long-term scarring. In addition to the standard approach to acne management, women with PCOS

Fertility treatment 70-80% of women with PCOS are reported to experience some degree of infertility, while PCOS is responsible for 75-80% of all infertility cases relating to anovulation. It is therefore very important that clinicians do not delay in referral for fertility support for PCOS patients. Prior to commencing fertility treatment, it is imperative that other causes of subfertility are ruled out. This includes tubal patency testing and

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Women’s Health PCO Syndrome

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Figure 3: infertility algorithm for PCOS. Image source: Recommendations From the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome

semen analysis. As mentioned previously lifestyle improvement is key to fertility optimisation.

The cornerstone of this is weight management, ensuring smoking and alcohol cessation as well as commencing high dose 5mg folic acid daily prenatally in obesity.

The 2023 international consensus guidelines outline an algorithm for approaching infertility in PCOS (Figure 3). First line medical management of infertility is Letrozole, which is recommended before clomiphene due to the lower risk of multiple pregnancy.

Metformin can also be added to clomiphene and is shown to be more effective than clomiphene alone. Further approaches are based on the presence or absence of ovulation. If ovulation is not achieved, ovulation induction with gonadotrophins and follicular tracking is recommended. If ovulation is detected repeated cycles of these medications is recommended before moving to assisted reproductive technologies (ART) such as in vitro fertilisation (IVF) +/- intracytoplasmic sperm injections. Recent research has shown that although more people with PCOS are using fertility treatments (38%) compared to those without PCOS (13%), the birth rate is the same across both groups. Therefore, with careful management and optimisation of fertility treatments PCOS patients can go on to have healthy and successful pregnancies.

Conclusion Polycystic ovary syndrome is a common and underdiagnosed condition amongst women, resulting in menstrual irregularities, androgenic features, subfertility, and long-term metabolic health

complications. Early consideration and workup are imperative for prompt diagnosis and initiation of treatment. PCOS patient’s care needs are very likely to vary and develop throughout their journey, therefore a holistic and flexible

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management approach is key to ensure these needs are met across each juncture in their lives.

Key further reading: Recommendations From the 2023 International Evidence-based

Guideline for the Assessment and Management of Polycystic Ovary Syndrome. Eur J Endocrinol.

2023 Aug;189 (2):G43-G64. doi: 10.1093/ejendo/lvad096.

References available on request

CPD 112: WOMEN’S ABDOMINAL PAIN Continuing Professional Development

CPD

AUTHORS: Eibhlín B. Windrim1, Brian E. McGuire1,2 & Hannah Durand3 1

School of Psychology, University of Galway

2

Centre for Pain Research, University of Galway

3

Division of Psychology, University of Stirling

Brian McGuire

60 Second Summary Abdominal pain refers to pain that occurs between the chest and the pelvic area. It can present as cramping, dull, aching, sharp, or stabbing pain that may be either constant or intermittent.

Abdominal pain affects between 22% and 25% of the population, with a higher prevalence among women (24%) than men (17%).

The Gender Pain Gap refers to the phenomenon in which women’s pain is more poorly understood and undertreated compared to pain in men due to systemic gaps and biases.

Sex and gender influence the presentation of pain, which in turn influences patient care. In general, pain is underestimated by healthcare professionals (HCPs); however, evidence suggests male patients’ pain is overestimated relative to female patients’ pain.

The ability of HCPs to accurately assess patient pain is often compromised by pre-existing gender biases, which determine how pain is addressed and treated in healthcare settings.

The current study aimed to explore women’s experiences of accessing healthcare for abdominal pain in Ireland using a qualitative approach. Women over the age of 18 years who were resident in Ireland and had attended Irish healthcare services for abdominal pain were invited to take part in the study.

Our findings also have implications for healthcare practice and public health.

Participants in this study had a wide variety of underlying causes for their abdominal pain, and as such encountered several different medical specialists. It is therefore particularly striking that participants’ experiences of engaging with the healthcare system were so similar.

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

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

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.

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

3. PLAN - If I have identified a

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

Hannah Durand 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.

Women’s experiences of seeking healthcare for abdominal pain in Ireland: a qualitative study Abdominal pain refers to pain that occurs between the chest and the pelvic area. It can present as cramping, dull, aching, sharp, or stabbing pain that may be either constant or intermittent.

Abdominal pain can be acute or chronic. Acute abdominal pain typically presents suddenly and may be associated with nausea or vomiting, and is often attributable to infection, inflammation, perforation, or obstruction.1 Chronic abdominal pain lasts for greater than three months’ duration,2 and may be indicative of underlying pathology;3 however, the underlying cause of abdominal pain cannot be specified in about one third of patients.4 Abdominal pain often affects functional capacity and quality of life and is a leading cause of healthcare utilisation internationally.3 Abdominal pain affects between 22% and 25% of the population, with a higher prevalence among women (24%) than men (17%).5,6 Gastrointestinal issues such as irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) account for much of the abdominal pain experienced by both men and women, with sexbased differences in pathogenesis and presentation being well established.7,8 However, abdominal

pain is also a common symptom of a wide variety of gynaecological conditions, such as endometriosis, fibroids, ovarian syndromes, and pelvic inflammatory disease.3,9 Pain in the abdomen during menstruation (i.e., dysmenorrhea) secondary to various gynaecological disorders and/or as a primary form of disease is also common and debilitating.10, 11 Healthcare and the gender pain gap The Gender Pain Gap refers to the phenomenon in which women’s pain is more poorly understood and undertreated compared to pain in men due to systemic gaps and biases. Clinical trials and other types of health research have traditionally adopted a ‘male as default’ or andronormative approach,12 which limits our understanding of pain conditions that predominantly affect women or how certain conditions affect men and women differently. This phenomenon has also contributed to the normalisation of women’s pain and gender biases within healthcare,13 which may result in women not seeking help for debilitating symptoms and impact the nature and quality of healthcare interactions for those who do. In their systematic review on gender

bias in healthcare, Samulowitz and colleagues12 identified a distinct pattern of gendered norms in the chronic pain literature. Women were presented as having greater bodily awareness and therefore heightened sensitivity to pain relative to men. It was also commonly suggested that pain without an identifiable cause is a natural characteristic of the female body. Additionally, women’s pain is more likely to be considered hysterical or psychological in origin, and as such is more likely to be described as ‘medically unexplained.’

Sex and gender influence the presentation of pain, which in turn influences patient care. In general, pain is underestimated by healthcare professionals (HCPs); however, evidence suggests male patients’ pain is overestimated relative to female patients’ pain.14 The ability of HCPs to accurately assess patient pain is often compromised by pre-existing gender biases, which determine how pain is addressed and treated in healthcare settings.15 Gender variations in healthcare experiences have been observed for abdominal pain, specifically. In their study on gender disparity in the analgesic treatment of acute abdominal pain in emergency

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CPD 112: WOMEN’S ABDOMINAL PAIN

Table characteristics Table 11 Participant Participant characteristics From: Women’s experiences of seeking healthcare for abdominal pain in Ireland: a qualitative study

From: Women’s experiences of seeking healthcare for abdominal pain in Ireland: a qualitative study ID no.

Pseudonym

Age group

Nature of pain

01

Alice

18–29

Dysmenorrhea, PCOS, ruptured cysts

02

Barbara

18–29

Dysmenorrhea, unidentified gastrointestinal issues, IBS

03

Charlotte

18–29

Unidentified abdominal pain, dysmenorrhea

04

Danielle

18–29

Unidentified abdominal pain

05

Emily

18–29

Endometriosis, PCOS

06

Fiona

30–39

Interstitial cystitis, PCOS, IBS, fibroids, endometriosis, PMDD

07

Grace

18–29

Dysmenorrhea, unidentified abdominal pain, PMDD

08

Hilary

18–29

PCOS, endometriosis, adenomyosis

09

Isabelle

18–29

Unidentified gastrointestinal issue

10

Jessica

18–29

Unidentified abdominal pain

11

Katherine

30–39

Endometriosis, fibroids

departments, Chen et al.16 reported that, although women were more likely to present with abdominal pain than men, they were less likely to receive pain relief than men reporting similar pain scores.

Women’s abdominal pain is often considered less serious than men’s, oftentimes being dismissed as ‘just’ dysmenorrhea17 without due regard for severity or impact of the pain.18 Due to the normalisation of dysmenorrhea, both socially and medically, perceived dismissal of women’s abdominal pain symptoms in healthcare contexts is common.16, 17, 19, 20 Experiences of dismissal by HCPs can lead to feelings of guilt, inadequacy, and helplessness, which can impact self-efficacy and resilience as well as future help-seeking behaviour.

In Ireland, women have been demonstrated to delay seeking necessary healthcare assistance for a month or more on average.21 Delay was influenced by women’s knowledge, beliefs, and social factors; in particular, women were more likely to delay when they anticipated that they would not be heard by HCPs. Validation from HCPs is important to ensure patients feel comfortable in seeking help.22, 23 Anticipated or experienced invalidation by HCPs

may explain the greater tendency for women to self-advocate and utilise more self-advocacy strategies than men.24 Women may develop these skills and strategies, particularly health informationseeking,25 in an attempt to overcome the challenges they face in accessing care.

The Gender Pain Gap is a systemic issue; therefore, it is useful to consider the various contextual determinants that may influence the experiences of women with pain within specific healthcare systems and distinct socio-political and cultural landscapes. Ireland has a two-tier healthcare system, consisting of both private and public healthcare services.26, 27 This type of system can exacerbate healthcare disparities and result in fragmentation of care and strain on public service resources.27 This two-tier system has its origins in the early 1900s and is in large part a consequence of the Catholic church’s historical alliance with the medical profession in Ireland.28 Although modern Ireland may be described as socially liberal, some would argue its conservative history can still be seen in the church’s continued influence over Irish

healthcare policy and delivery,28 which may disproportionately impact female patients. Repeated women’s healthcare-related scandals, both historical29, 30 and contemporary,31, 32 have demonstrated Ireland’s poor track record in providing adequate care to women. Although there have been substantive changes to women’s health policy in response to public outcry in recent years, the extent to which these have impacted women’s healthcare experiences to date is unclear.

Cumulatively these factors are likely to influence women’s painrelated help-seeking behaviour, as well as the quality of care they receive. However, there is a dearth of research on the experiences of women seeking healthcare for abdominal pain in the Irish context to date.

undertreated. However, there is a dearth of research on the experiences of women with abdominal pain accessing healthcare in the Irish context, specifically. Given the unique interplay of healthcare systemrelated factors, social and cultural factors, and recent changes in women’s health policies and practice,33, 34 understanding women’s experiences of seeking help for abdominal pain in Ireland can provide important insights to help optimise healthcare delivery nationally, while contributing to the broader global discourse on sex- and gender-based disparities in healthcare.

The current study aimed to explore women’s experiences of accessing healthcare for abdominal pain in Ireland using a qualitative approach.

Cumulatively the literature suggests that there are clear gender-based disparities present in healthcare systems, which can negatively impact the experiences of women with pain. In particular, women who present with abdominal pain are likely to have their pain experiences dismissed or invalidated, and to have their conditions misdiagnosed and

Method Participants and recruitment Women over the age of 18 years who were resident in Ireland and had attended Irish healthcare services for abdominal pain were invited to take part in the study. No restrictions were placed on the type, severity, or duration of abdominal pain. A

31 convenience sampling approach was taken. Study information was disseminated via social media platforms (Reddit, LinkedIn, Facebook, and Twitter) and flyers were posted on the university campus and at healthrelated conferences. Snowball sampling was also used, whereby participants were encouraged to share the study information with others who may have been eligible to take part. Recruitment took place over a period of four months (March–June 2023).

A total of 14 women took part in the study. Data collection ceased once data adequacy (i.e., data sufficient to answer the research question in both amount and variety35) was achieved according to evaluation by all members of the research team. Participant information is presented in Table 1. Only age groups are reported to better protect participant anonymity.

Study design and procedure A qualitative interpretative approach to the research was employed. One-to-one interviews were used to explore participants’ experiences of the healthcare system in Ireland when presenting with abdominal pain. Interviews were conducted by the lead author (EBW) via video-conferencing platforms Zoom and Microsoft Teams, where participants were invited to remain on- or offcamera, as desired. Interviews were semi-structured and followed a previously prepared interview guide. Time was allocated at the start of each interview to inform the participant of the study’s purpose and content, to obtain Windrim et al. BMC Women's Health

informed consent, and to build rapport with the participant.

Participants were encouraged to ask any questions they had concerning the research and their participation and were reminded that they were not obligated to share any information with which they were uncomfortable. The interviews lasted an average of 31 min (range: 15–55 min).

Interviews were audio-recorded and transcribed verbatim by the lead author (EBW) for analysis.

Transcripts were validated by a senior author (HD) to ensure they accurately captured participants’ verbal and non-verbal communication (e.g., pauses, laughter). After transcription, audio recordings were destroyed.

Ethical approval was obtained from the School of Psychology Research Ethics Committee at the University of Galway (Ref: SREC-17-Feb-23). Ethical standards of the institutional research committee were upheld throughout the research process.

Data was handled and stored in accordance with requirements set out by General Data Protection Regulation (GDPR).

Data analysis Reflexive thematic analysis according to Braun and Clarke36,37,38 was used to analyse the data. An inductive approach was taken, whereby themes were entirely derived from the data. This analysis approach comprised the following six stages: 1. Familiarising yourself with the data: Interview recordings were transcribed verbatim by the lead author, facilitating familiarisation with the data.

(2024) 24:166

2. Generating initial codes: A semantic approach was taken to generate codes, by extracting relevant phrases and sentences from the data, establishing recurrences throughout the data.

3. Searching for themes: Relationships between codes were considered using visual representations. Codes were then divided based on similarity, creating themes.

4. Reviewing themes: The coded data extracts were reviewed for each theme. The validity of each theme was reviewed in relation to the dataset and the research topic, to ensure the analysis provided an accurate representation of the data and addressed the research aim.

5. Defining and naming themes: Each theme was given an operational name and definition.

Each theme was defined by identifying its context and depth in relation to the research question.

6. Producing the report: A detailed account of each theme supported with extracts from the transcripts was established within the final report.

The analysis was undertaken by the lead author, with support from a senior author (HD) with extensive experience in qualitative health research. The lead author transcribed the interviews, developed the codes, and generated an initial set of themes. The research team had frequent meetings to discuss the data and analysis throughout this phase. Codes, categories, Page 5 of 12

Fig 1. Summary of themes

and initial themes were reviewed by a senior author (HD) for comprehensiveness, coherence, and grounding in the data. Any proposed refinements to the themes were agreed among all authors.

The credibility of the findings was ensured through prolonged engagement with the data and frequent in-depth discussions among the research team during the data collection, analysis, and writing processes. Peer debriefing, whereby findings and interpretations were discussed with colleagues not directly involved in the research to help identify any potential biases, challenge assumptions, and gain additional relevant insights, was practiced during the analysis stage to enhance the credibility of the findings.39 Reflexivity Reflexivity was practiced throughout the research process.

Reflexivity involves researchers acknowledging and critically reflecting their role in shaping the research and its findings, including how personal beliefs, values, and experiences may impact data collection, analysis, and interpretation.40 The lead author and interviewer (EBW) was a young cisgender female living in Ireland with experience of the Irish healthcare system. This may have facilitated rapport-building with participants, who largely shared similar characteristics.

Reflexive writing was employed to record the researchers’ viewpoints and decisions throughout the research process, establishing a reference log for later stages of the research. This also enhanced the dependability and confirmability of the findings.41 The research team also met frequently to practice collaborative reflexivity, questioning each other’s assumptions and decisions from their individual perspectives across all stages of the research. Peer debriefing, as described above, also facilitated reflexivity.

Results Four themes were constructed from the data. These are outlined to the left (See Fig 1) and illustrated using supporting quotations.

Discussion The current study aimed to explore the help-seeking experiences of women with abdominal pain in Ireland. Participants’ experiences were largely negative, characterised by feelings of dismissal and invalidation, struggle to have symptoms taken

Fig. 1 Summary of themes

“‘Oh, it’s normal, and a lot of people have really painful periods, it’s just part of being a woman, blah blah blah…’” (P01, quoting HCP)

participants described doctors treating their pain as standard for their condition rather than listening to their individual pain experience or the ways in which pain impacted their lives.

32

CPD 112: WOMEN’S ABDOMINAL PAIN

seriously, and frustration with systemic barriers to diagnosis and treatment. Internalised normalisation of pain was apparent in this sample, with many participants describing a perceived need for their pain to reach a certain (high) threshold of severity, as evaluated by themselves or others, before seeking medical attention. Participants felt that they were primarily responsible for making sure they received the care that they needed. Despite feeling frustrated with their healthcare experiences, participants acknowledged that many of the barriers they faced were systemic and expressed empathy for HCPs operating within a flawed system.

Past experiences of perceived dismissal by HCPs affected participants’ willingness to seek healthcare. Participants emphasised the importance of feeling heard by HCPs, with some stating that their doctor’s ability to make them feel heard was more important to them then their medical expertise. This is consistent with previous literature, which highlights that listening is essential for building a trusting patient-doctor relationship that facilitates open communication.22,42 Resource limitations within the healthcare system, particularly in public healthcare, place extreme pressures on HCPs’ time, which may exacerbate patients’ feelings of dismissal.

Participants suggested that a more collaborative approach to healthcare could be beneficial not only for their own health, but also for HCPs. This could alleviate some of the pressures faced by HCPs, and GPs in particular, to be “expert in everything.”

All women in this study emphasised the importance of self-advocating in order to be taken seriously by HCPs. Although women have been shown to have greater self-advocacy intentions, these do not appear to be associated with less negative clinical experiences regarding pain,24 suggesting that disparities in care cannot be attributed to women failing to self-advocate. It is likely that these disparities are in part due to the normalisation of women’s abdominal pain.

Both women and doctors may assume that their abdominal pain is normal, even when that pain is severe.17, 20, 43 This is also a systemic issue, whereby pressures on the healthcare system result in the de-prioritisation of “nonurgent” or “non-malignant” issues, without due consideration for the impact on functioning or quality of life. Clearer conceptualisation

of health and illness according to the International Classification of Functioning, Disability and Health (ICF)44 in the healthcare system, whereby activity limitations and participation restrictions are central, could help alleviate some of these issues.

Implications of the findings The current findings have important implications for future research. This qualitative study provides important insight into the lived experience of women seeking care for abdominal pain in Ireland. Large-scale quantitative research is now needed to better understand the extent of the issues identified in the current study.

Probability sampling approaches that account for key demographic factors like age, socioeconomic status, and geographic location should be used to ensure findings are as robust as possible. This research should also consider the experiences of male patients presenting with abdominal pain to better understand the gendered and non-gendered issues in this context. Quantifying the extent of gender-based disparities in assessment and treatment of abdominal pain is necessary to underscore the importance of future investment in efforts to make healthcare in Ireland more equitable. Future research should also aim to understand the views and perspectives of HCPs on how care is delivered to women with abdominal pain in Ireland. The experiences of HCPs are typically overlooked in this literature, which may result in a biased assessment of the barriers and facilitators of care for women with pain.

Understanding their perspectives as well as those of patients would enable the development of a more comprehensive approach to addressing these issues.

Our findings also have implications for healthcare practice and public health. Participants in this study had a wide variety of underlying causes for their abdominal pain, and as such encountered several different medical specialists. It is therefore particularly striking that participants’ experiences of engaging with the healthcare system were so similar. This demonstrates that the issues raised in this study are not specific to any one medical discipline, but rather reflective of the healthcare system as a whole. Medical education and professional development opportunities are needed to ensure HCPs are equipped to understand and treat women’s abdominal pain, and to refer to the appropriate specialists as needed. Consideration of

the impact of pain on women’s functioning is essential in this regard; therefore, these initiatives should be informed by the ICF44 and emphasise the impact of unmanaged pain on quality of life. Furthermore, it was apparent in this study that participants internalised normative views of women’s pain, which affected their help-seeking behaviours.

Public health campaigns to promote appropriate help-seeking for pain that interferes with daily functioning should be developed to ensure women with abdominal pain receive pain management support and timely diagnosis of any underlying pathology.

Strengths and limitations Certain limitations should be considered when interpreting the findings of this study. Participants self-selected into the study, which means the findings may be subject to certain biases. In particular, individuals with negative healthcare experiences may have been more motivated to take part. Participants were also white, well-educated, and largely had the means to access private healthcare. Therefore, the research lacks insight into potential cultural or sociodemographic factors that may affect help-seeking experiences. That said, cost was discussed by most participants as a prohibitive factor. Ireland has a two-tiered public-private health service.26, 27 Primary healthcare costs are payable by roughly 60% of the population, at an average cost of approximately ¤50 per GP visit,45 with over one-third of private patients paying up to ¤75 per visit.46 Though the General Medical Services Scheme exists to allay some of these costs for individuals on a reduced income,47 it is likely that those who are less well-off financially may experience additional barriers to accessing care.48 Additionally, most participants were between 18 and 29 years of age, which may limit the generalisability of findings to other age groups.

Older women may have different healthcare needs, expectations, and experiences, and engage in different healthcare-seeking behaviours compared to younger women. That said, the current findings provide important insight into the experiences of young women, who may face unique barriers to receiving adequate care.49 Finally, only cisgender women took part in the study. Experiences of and barriers to healthcare for LGBTQIA + individuals with female anatomy who experience abdominal pain are likely to be

different from those of cisgender women.50, 51 Future research should aim to understand the experiences of diverse groups of individuals to make the research literature and healthcare practice more inclusive.

Limitations notwithstanding, the current study makes an important contribution to the literature on help-seeking experiences for women with abdominal pain.

Steps were taken to ensure the analysis was conducted rigorously and that principles of reflexivity were adhered to throughout the research process, which strengthens the validity of our conclusions. Inclusion of women with different kinds of abdominal pain, including unspecified pain, strengthens the research.

Condition-specific approaches run the risk of forcing conclusions that challenges to accessing healthcare may be discipline-specific. While certain specialties or treatments may be less accessible due to, for example, resource limitations, our findings provide evidence that gender-specific challenges to receiving care for abdominal pain are prevalent across the healthcare system. This strengthens our assertion that system-wide change is needed to promote the health and wellbeing of women experiencing pain.

Conclusions Participants described mostly negative experiences of seeking healthcare for abdominal pain.

Previous experience of dismissal of symptoms and social perceptions influenced participants’ willingness to engage with healthcare services. Women may internalise the idea that severe pain is normal and attempt to tolerate it without effective support, potentially to their long-term detriment.

Participants’ experiences with healthcare reinforced their view that self-advocacy is essential to allow them the chance to receive care for their pain. There are systemic issues at play within the Irish healthcare system that limit women’s ability to access abdominal pain management support. Public health campaigns that challenge normative views of women’s abdominal pain as not warranting healthcare intervention and promote appropriate helpseeking for disabling pain are needed. Education and training for HCPs on the Gender Pain Gap and its implications for patient care, as well as clear referral pathways for women presenting with abdominal pain, are needed to ensure more equitable healthcare delivery for individuals with pain in Ireland.

References available on request

Women’s Health Genitourinary Syndrome

33

Genitourinary Syndrome of Menopause Genitourinary syndrome of menopause (GSM), previously referred to as vulvovaginal atrophy (VVA) or atrophic vaginitis, is a common symptom of menopause. It may be present in perimenopause, but is more likely to become apparent as women progress through their menopause journey. Unlike vasomotor symptoms of menopause which will improve with time, genitourinary problems often persist and progress due to prolonged hypoestrogenism.

GSM is one of the most consistently identified predictors of sexual dysfunction in women, but is often underdiagnosed and undertreated. Many women do not voluntarily discuss these symptoms with their healthcare provider, and many healthcare professionals do not ask patients about it directly.

While the exact prevalence rates vary depending on the source it is estimated that between 36% and 84% of women in perimenopause and menopause will experience genitourinary symptoms.

GSM refers to a syndrome of defined signs and symptoms related to hypoestrogenic changes of the female genitourinary tract.

The symptoms of GSM are directly related to the reduction in circulating estrogen levels after menopause. An abundance of estrogen receptors are present in the vagina, vulva, pelvic floor muscles, urethra, and bladder. As a result of the estrogen deficiency that occurs in menopause, both histological and anatomical changes occur in urogenital tissues. These changes lead to a thinning of the vaginal mucosa, reduced vaginal elasticity, increased vaginal pH leading to changes in the normal vaginal flora and decreased lubrication, all of which leave the tissues vulnerable to irritation, infection and trauma.

Symptoms include: • Vaginal and vulval irritation, itching, burning or discomfort • Urinary symptoms of urgency, frequency, nocturia and dysuria • Recurrent urinary tract infections • Lack of lubrication and pain during intercourse • Light bleeding related to local trauma (for example insertion of a pessary)

Diagnosis is made based on the patient’s history and examination.

As mentioned above, patients may not willingly disclose these symptoms and so healthcare providers should actively ask about them. An examination is important to rule out other causes of vaginal discomfort including Lichen Sclerosis, Lichen Planus, vulval dermatoses and malignant conditions. Signs of GSM include changes in tissue colour (ranging from pallor to inflammation), loss of elasticity, friable tissue that easily bleeds, petechiae and vaginal discharge.

For most women, further investigations are not necessary.

If a vaginal discharge is present a high vaginal swab may be done to rule out candidiasis, bacterial vaginosis and sexually transmitted infections. Cervical smear tests should be kept up to date, although the smear taker should be mindful that the procedure may be traumatic to local tissues and extra lubrication may be required.

Urinalysis may be required in patients presenting with urinary symptoms and a microscopy and culture should be considered for women experiencing recurrent urinary tract infections. Any abnormal vaginal bleeding should be investigated as appropriate.

Treatment of GSM is vital in order to restore normal function of the urogenital tissues as well as to alleviate these very bothersome symptoms and improve quality of life. As the primary cause of these symptoms is a lack of estrogen, local estrogen therapy and/or systemic HRT would be considered the most logical first line therapy unless there is a contra-indication.

It is important to note that local estrogen therapy is not considered to be HRT as it has little to no systemic absorption. The NICE Guidelines are quite clear that vaginal estrogen should be offered to women with GSM, even if on systemic HRT, and that it should be continued for as long as needed to relieve symptoms. It can and should be considered in women in whom systemic HRT is contraindicated, after seeking advice from a menopause specialist.

Local estrogen replacement can restore vaginal pH and helps to thicken and revascularise the vaginal epithelium. Vaginal estrogen use is also associated with a reduction in urinary symptoms and a decreased

incidence of urinary tract infections. Vaginal estrogen can be absorbed from the vagina and surrounding area via a pessary, cream, gel or vaginal ring. There are two types of estrogen used – estradiol and estriol. Time to respond to therapy will depend on the degree of atrophic changes present when starting. Women with severe symptoms may only notice an improvement after several months. For many women, symptoms will return once the treatment is stopped, and so it is both safe and reasonable to continue vaginal estrogen therapy long-term.

Systemic HRT will very effectively treat genitourinary symptoms in women who have other menopausal symptoms and in whom HRT is not contra-indicated.

Systemic HRT may also be used together with vaginal estrogen in those women who have persistent symptoms of GSM. Non-hormonal treatments may be used alongside, or in place of, hormone therapies. They do not restore normal vaginal physiology.

They are a good treatment option for women with mild symptoms, or for those women that do not want to use hormonal treatment.

Vaginal moisturisers, used on a regular basis, may offer relief from symptoms of vaginal dryness.

They help to retain moisture in the mucosa and may balance the vaginal pH. They should be used regularly for maximum benefit.

Vaginal lubricants are intended for use with any sexual or penetrative activity, including speculum exams. Care is needed in selecting preparations which are appropriate for the vaginal environment and free of potential irritants such as glycerol. There are a wide variety

Written by Dr Genevieve Ferraris, Menopause Specialist at The Menopause Hub, Dublin

Written by Dr Genevieve Ferraris, Menopause Specialist at The Menopause Hub, Dublin of overthe-counter products available and these may be water, oil, or siliconbased. Patients should be advised that oil-based lubricants may negatively affect condom integrity.

Vaginal laser therapy should not be offered to patients, as studies have shown no benefit over placebo.

Patients may require referral to a pelvic floor physiotherapist who can assist with treatment of vaginismus and hypertonicity, pelvic floor dysfunction, and the use of vaginal dilators if appropriate.

Other general recommendations for patients with GSM would be around minimising vaginal irritation.

This can include wearing cotton underwear, avoiding very tight underwear and trousers, washing with warm water only and to avoid the use of soaps, bubble baths and feminine hygiene sprays.

In conclusion, genitourinary symptoms of menopause are common, bothersome and underdiscussed by both patients and doctors. Healthcare providers should actively ask about symptoms, and should feel reassured that local estrogen therapy can be safely prescribed in almost all menopausal women with GSM. Systemic HRT may be offered to women who have other menopause symptoms and do not have contraindications to use. Vaginal moisturisers and lubricants can be helpful adjuncts to hormone therapy, or may be used alone in women with mild symptoms or who do not wish to use hormonal treatments.

HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

Women’s Health Menopause

34

Movement through Menopause Written by Dr Kirsty Hedding, The Menopause Hub Menopause Society Certified Practitioner, MBChB (UCT), MPhil (EM) (UCT)

exercise creates and how that influences a woman’s physiology in a positive manner improving sensitivity to pain and hot flushes.3 However, the size of this effect may vary between individuals. Other evidence suggests that regular sustained aerobic exercise (like swimming) has the most benefit in reducing these symptoms.1 2) Improved sleep: regular moderate to vigorous exercise can help sleep by reducing the time it takes to fall asleep as well as improving the quality of sleep.3 Improved sleep results in less fatigue during the day, an improvement in mood and a greater chance of repeating regular exercise.1 Good sleep can also help women make better food choices during the day.

Exercise has long been a fundamental component of being healthy. However, for women in particular, it has largely been seen as a tool to either ‘look a certain way’ or manage their weight. The idea that only certain exercises are beneficial has also contributed to this negative image.

Exercise or movement should instead be explored and celebrated as a means to improve our health and wellbeing. It is one of the most powerful tools we can use to remain healthy and prevent disease, but also challenge ourselves and feel great.

This is important for anyone as they age, but particularly for women as they transition through menopause. The menopause transition can be one of the most challenging periods in a woman’s life.1 This is due to the wide variety of symptoms they can experience at this time from physical to mental.1 These symptoms can vary in severity, duration and most importantly how they impact her daily life, and ultimately her future.1,2,3

While symptoms and management of menopause have gained more attention recently, there is still not enough awareness of the health consequences associated with being post-menopausal.

Post-menopausal women are at higher risk for certain diseases, particularly cardiovascular disease and osteoporosis.1 • Did you know that 1 in 4 women die from heart disease and stroke?4 • Did you know that coronary heart disease (atherosclerotic heart disease) results in twice as many deaths in women as breast cancer?1 • Did you know that around 25% of women will have developed osteoporosis by the time they are 80 years old?1 • Did you know that 20% of women who sustain a hip fracture will die as a result?

For those that survive, most will be left with some form of disability, requiring long-term care and possibly the inability to live independently.1

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

While hormone replacement therapy (HRT) can play an important role in both treating the symptoms and helping prevent diseases caused by the lack of oestrogen, our day-to-day lifestyle is as pivotal.1 Things like smoking, obesity and excessive alcohol consumption can all impact a woman’s risk of developing ischaemic heart disease, diabetes, and a variety of cancers, most especially breast.1 Given that a lot of these factors are within our control, relying on HRT alone would be unwise, especially as not everyone is able to use it.

So how can movement help women during the menopause transition?

1) Reducing severity of symptoms: although the studies done in this regard are small and limited, women who were more physically active during this period, reported less severe symptoms, particularly vasomotor symptoms (hot flushes/night sweats).3 It is thought that this may be attributable to the endorphins

3) Reducing stress: movement reduces stress through enjoyment, time to oneself or through connection with a community.3,4 Also, depending on the type of exercise you participate in, it can bring you closer to nature which often has a calming effect.5 4) Improvement in mood symptoms: Irritability, low mood and mild depression is common during menopause.6 Exercise can be as effective as some medications at treating this.

It additionally helps improve your self-esteem, which in turn improves overall well-being.3 How does exercise help prevent disease?

• Exercise stresses our bones by applying force to them, either through impact (like running) or through the muscles exerting a force on them through pulling. This in turn forces the bone to adapt and become stronger, reducing the likelihood of a fracture.

• Exercise can assist with increasing muscle mass which both enhances our metabolism, helping with weight maintenance.

• Movement assists with strengthening our balance, which will prevent a fall, and

35

possible broken hip.1 Exercising with a focus on balance is particularly important for women over the age of 65 years.4 • Mobility and strong muscles enable us to remain active and independent for as long as possible.1 • It can strengthen the heart and cardiovascular system, allowing it to function at an optimal level.4 • Daily exercise can help lower blood pressure in women with high blood pressure, decreasing it by up to 5-7mmhg. This ultimately helps to decrease the risk of developing strokes or heart attacks.5 • Atherosclerosis, which results in cerebrovascular disease, is thought to be worsened by chronic inflammation, and exercise has been shown to play a role in decreasing inflammatory markers and preventing vascular endothelial dysfunction.7

• Obesity increases a person’s risk for chronic diseases, like diabetes as an example.1 The menopause transition is known to be associated with significant weight gain, although studies have attributed this to age and lifestyle, not specifically menopause. Although once again small, studies that looked at women who did regular physical exercise during menopause, were found to gain the least amount of weight.8 Understanding the benefits of exercise in more detail can help motivate women to add movement to their lives both during the menopause transition and afterwards. Yet, it must be said that for many women, the very idea of ‘exercise’ can be completely overwhelming. This can be for many external reasons like shift work, long commutes or family responsibilities. Most importantly, the menopause itself contributes significantly to fatigue, lack of motivation and pain, all

of which can prevent women from doing something.

Encouraging movement isn’t to undermine the experience women go through during this time, but rather to help fuel their ‘why’ to do something worthwhile.

So where can you start?

1) Chat to your healthcare provider about what exercise is safe for you and/or would be of most benefit to you. This is particularly important if you have medical conditions or physical limitations that may make certain exercises risky.

2) Movement comes in a variety of shapes and sizes, so pick something that brings you joy.

You get to choose what this looks like and it will be unique for every woman.

3) Start small and increase slowly. the recommended time by the World Health Organisation (WHO) for aerobic exercise is 150 minutes of moderate

exercise per week.1 Breaking this into chunks of ten minutes at a time still provides the benefit, so don’t be intimidated by the overall amount.

4) Consistency is key, rather than an all or nothing approach.

5) Factor in failure and be kind to yourself when you skip a day.

6) In time, try to incorporate all forms of exercise: aerobic, balance exercises (particularly over the age of 65), resistance training and mobility.

Movement has the power to add considerable value to our lives, particularly in women experiencing menopause. Women who are just starting their movement journey, stand the most to gain. Rather than being intimidated by it, it can be seen as an opportunity for discovery, adventure, health and even growth. Our health after all, is one of our most important assets to living a life we love.

References available on request

HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

Women’s Health Heart Health

36

Her Heart Matters Written by Dr Angie Brown, Consultant Cardiologist & Medical Director, Irish Heart Foundation

Though the commonest symptom remains chest pain sometimes radiating to the arms, they can be more vague in women, who may also be breathless and dizzy. Women also tend to have more nausea and may underplay their symptoms.

The traditional risk factors of hypertension, high cholesterol, a family history of premature IHD, a sedentary lifestyle and obesity, affect men and women equally.

Cardiovascular disease is the leading cause of death in women in Europe and worldwide with many women living with chronic cardiovascular disease. Similarly, in Ireland one in four women dies from heart disease or stroke every year, the same as men.

Surprisingly very few women realise this or that their risk of dying of a heart attack or stroke is 6 times more likely than dying of breast cancer.

There are differences in the aetiology and sometimes the presentation of CVD in women leading to misdiagnoisis. For instance, younger women are more likely to present with myocardial infarction/ischaemia in the absence of obstructive coronary artery disease (MINOCA/ INOCA), with coronary artery dissection (SCAD) or Takotsubo cardiomyopathy. Further more women are protected by their hormones until the menopause so may develop atherosclerotic disease a bit later than men.

Together this has meant that historically the public feel that heart disease is a man’s disease.

Research has shown that cardiovascular disease in women

has been under recognised, under diagnosed and under treated in the past. This is only now starting to change, though there are still far fewer women enrolled in clinical trials. This lack of awareness has meant women delay seeking help, and their symptoms may not be recognised and diagnosed quickly by health professionals, all of which lead to delays in effective and often life-saving treatment. The lack of women’s involvement in clinical trials has limited our knowledge of the efficacy, safety, and correct dose of many therapies in women compared to men which has led to the underutilisation of preventative treatments and interventions for CVD in women. It is therefore important to remove barriers for women entering clinical trials and encourage their participation so we can better understand their specific risk factors and response to treatment.

The Irish Heart Foundation’s campaign ‘Her Heart Matters’ is a very important campaign trying to address these misconceptions and raise awareness of the signs and symptoms of a heart attack as 50% of women are unaware of these signs and symptoms.

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

However, diabetes in women increases the risk of developing cardiovascular disease more than men and may mean they are less likely to feel pain if they are having a heart attack.

Smoking increases the risk of cardiovascular disease in everyone but women who smoke have a much higher risk of heart disease than men, the risk increasing with the number of cigarettes smoked. The recent AMI audit confirmed smokers have a heart attack 9 years earlier than those who don’t smoke.

It’s also important to know there are sex specific risk factors. These include a premature menopause.

The lack of oestrogen leads to stiffening of the coronary arteries and alters the lipid profile increasing cardiovascular risk.

Preeclampsia and gestational diabetes increase’s a women’s long term risk of developing CVD. Polycystic ovaries, inflammatory and autoimmune disorders may also increase the risk of heart disease. Psychosocial risk factors, socioeconomic depravation, poor health literacy and environmental risk factors also have a role in increasing risk.

The good news is 80% of premature cardiovascular disease is preventable.

In addition to managing the traditional risk factors by ensuring control of blood pressure, blood sugar and cholesterol, stopping smoking and modifying the diet, it is important to remember that physical activity is one of the greatest tools for prevention of cardiovascular disease, as well as improving mental health and menopause symptoms. A minimum of 150 minutes of moderate intensity activity a week divided into manageable and enjoyable sessions is recommended.

Stress is something else we all have in our lives but it’s important to manage it. For some it becomes negative, impacting on day to day lives. When we are stressed we are more likely to drink and smoke more and eat unhealthily.

This coupled with the release of cortisol, which raises blood glucose and adrenalin, raises the heart rate and blood pressure and can increase cardiovascular risk.

Again, exercise has a role here as it releases tension and helps improve sleep. Staying connected to friends and family and your support network is important.

Sometimes if things become overwhelming it’s worth talking to your GP and seeking professional help.

There has been a welcome focus around women’s health issues with the Governments Women’s Health Action Plan as phase 2 includes emphasis on improving cardiovascular health. Hopefully this will address some of these issues. We need to invest in research assessing women’s cardiovascular health, support more awareness raising activity and ensure educational activities for healthcare professionals to ensure they are better equipped to assess and treat specific risk factors and identify signs and symptoms of CVD in women.

Currently females are also under represented in the cardiology profession so we need to continue to increase the number of women working as cardiologists.

For more information see irishheart.ie

®

®

GO BEYOND LOWERING LDL-C

ADD ON TO REDUCE CV RISK When statins* and ezetimibe are not enough, add on once daily oral Bempedoic Acid earlier, to help your patients go even further.1,2Δ * Concomitant use with simvastatin >40 mg daily is contraindicated; please refer to the relevant SmPC for more information.1,2

NILEMDO® and NUSTENDI® are indicated in adults with established, or at high risk for, ASCVD to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors, who are on maximally-tolerated statins, or statin-intolerant, or statin-contraindicated with or without ezetimibe or not adequately controlled with ezetimibe treatment.1,2

Δ

NILEMDO▼ (bempedoic acid) 180 mg / NUSTENDI▼ (bempedoic acid/ezetimibe) 180 mg/10 mg filmcoated tablets Abbreviated Prescribing Information ▼These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Refer to Summary of Product Characteristics (SmPC) prior to prescribing.

Presentation: Each Nilemdo film-coated tablet contains 180 mg bempedoic acid. Each Nustendi filmcoated tablet contains 180 mg of bempedoic acid and 10 mg of ezetimibe. Indications: Hypercholesterolaemia and mixed dyslipidaemia: Nilemdo/Nustendi are indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet: In combination with a statin (Nilemdo: or statin with other lipid-lowering therapies) in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin; alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated (Nustendi: and are unable to reach LDL-C goals with ezetimibe alone). Cardiovascular disease: In adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe or, in patients who are either statin-intolerant, or for whom a statin is contraindicated (Nustendi in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.) Posology and method of administration: The recommended dose is one tablet of 180 mg Nilemdo or 180 mg/10 mg Nustendi taken once daily, with or without food. Tablet should be swallowed whole. Concomitant simvastatin therapy: When Nilemdo/Nustendi are co-administered with simvastatin, simvastatin dose should be limited to 20 mg daily (or 40 mg daily for patients with severe hypercholesterolaemia and high risk for cardiovascular complications, who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks). Coadministration with bile acid sequestrants: Dosing of Nustendi should occur either at least 2 hours before or at least 4 hours after administration of a bile acid sequestrant. Patients with renal impairment: No dose adjustment is necessary when Nilemdo/Nustendi is administered in patients with mild or moderate renal impairment.

Additional monitoring for adverse reactions may be warranted in patients with severe renal impairment and patients with end-stage renal disease (ESRD) on dialysis when Nustendi is administered. Patients with hepatic impairment: No dose adjustment is necessary when Nilemdo/Nustendi is administered in patients with mild hepatic impairment (Child-Pugh A). Treatment with Nustendi is not recommended in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment due to the unknown effects of the increased exposure to ezetimibe. Contraindications: Hypersensitivity to the active substance or any of the excipients (see SmPC); pregnancy; breast-feeding; concomitant use with simvastatin > 40 mg daily. When Nustendi is co-administered with statin in patients with active liver disease or unexplained persistent elevations in serum transaminases; when Nustendi is co-administered with a statin, consult the SmPC for that particular statin therapy. Warnings and precautions: Potential risk of myopathy with concomitant statins: Bempedoic acid increases plasma concentrations of statins. Patients receiving Nilemdo and a statin should be monitored for adverse reactions that are associated with high doses of statins. Statins occasionally cause myopathy. In rare cases, myopathy may take the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria and can lead to fatality. In post marketing experience with ezetimibe, very rare cases of myopathy and rhabdomyolysis were reported. Most patients who developed rhabdomyolysis were taking a statin with ezetimibe. Patients receiving Nilemdo/Nustendi and a statin should be advised of the potential increased risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness. If such symptoms occur, a lower maximum dose of the same statin or an alternative statin, or discontinuation of Nilemdo/Nustendi and initiation of an alternative lipid-lowering therapy should be considered under close monitoring of lipid levels and adverse reactions. If myopathy is confirmed by creatine phosphokinase (CPK) > 10× upper limit of normal (ULN), immediately discontinue Nilemdo/ Nustendi and any statin. Doses of simvastatin > 40 mg should not be used with Nilemdo/Nustendi. Increased serum uric acid: Bempedoic acid may raise serum uric acid due to inhibition of renal tubular OAT2 and may cause or exacerbate hyperuricaemia and precipitate gout in

patients with history of gout or predisposed to gout. Discontinue Nilemdo/Nustendi if hyperuricaemia accompanied with symptoms of gout appear. Elevated liver enzymes: Liver function tests should be performed at initiation of therapy. Discontinue Nilemdo/Nustendi if increase in transaminases > 3× ULN persists. Renal impairment: Additional monitoring for adverse reactions may be warranted in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) or patients with ESRD on dialysis. Hepatic impairment: Periodic liver function tests should be considered for patients with severe hepatic impairment (Child-Pugh C) taking Nilemdo. Nustendi is not recommended in moderate to severe hepatic impairment (Child-Pugh B and C) due to unknown effects of increased exposure to ezetimibe. Fibrates: If cholelithiasis is suspected in a patient receiving Nustendi and fenofibrate, gallbladder investigations are indicated, and therapy should be discontinued. Ciclosporin: Caution when initiating Nustendi in the setting of ciclosporin.

Ciclosporin concentrations should be monitored. Anticoagulants: Appropriately monitor INR if Nustendi is added to warfarin, other coumarin anticoagulants, or fluindione. Contraception: Women of childbearing potential must use effective contraception during treatment. Patients should be advised to stop Nilemdo/ Nustendi before stopping contraceptive measures if planning to become pregnant. Excipients: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take Nilemdo/Nustendi as it contains lactose. Patients at high risk of cardiovascular disease: Evidence for the use of the fixed combination medicinal product of bempedoic acid with ezetimibe in patients at high risk of cardiovascular disease is only available for the lipid-lowering effect in absence of any cardiovascular risk reduction estimation for ezetimibe in primary prevention patients. Driving and use of machines: Nustendi has minor influence on ability to drive and use machines.

Dizziness has been reported. Interaction with other medicinal products: Refer to SmPC for full information on interactions. Adverse reactions: Nilemdo: Common (≥ 1/100 to < 1/10): Glomerular filtration rate decreased, anaemia, gout, hyperuricaemia (includes blood uric acid increased), AST increased, pain in extremity. Uncommon (≥ 1/1,000 to < 1/100): weight decreased, haemoglobin decreased, ALT increased, liver function test increased, blood creatinine increased, blood urea increased, Consult Nilemdo SmPC in relation to other adverse reactions. Nustendi: Common (≥ 1/100 to < 1/10): Glomerular filtration rate decreased, anaemia, decreased haemoglobin, hyperuricaemia (includes uric acid increased), decreased appetite, dizziness, headache, hypertension, cough, constipation diarrhoea, abdominal pain, nausea, dry mouth, flatulence, gastritis, liver function test increased (includes liver function test abnormal), back pain, muscle spasms, myalgia, pain in extremity, arthralgia, blood creatinine increased, fatigue, asthenia, gout, AST increased (for bempedoic acid), blood CPK increased. Uncommon (≥ 1/1,000 to < 1/100): weight decreased, ALT increased, blood urea increased, hot flush, dyspepsia, gastrooesophageal reflux disease, AST increased (for ezetimibe), GGT increased, pruritus (with statin), neck pain, muscular weakness (with statin), chest pain, pain, oedema peripheral (with statin). Frequency not known: Thrombocytopaenia, hypersensitivity (including rash, urticaria, anaphylaxis, angio-oedema), depression, paraesthesia (with statin), dyspnoea, pancreatitis, hepatitis, cholelithiasis, cholecystitis, erythema multiform, myopathy / rhabdomyolysis. Consult Nustendi SmPC in relation to other adverse reactions. Legal Classification: POM. Package quantity, marketing authorisation (MA) number: Nilemdo 28 tablets: EU/1/20/1425/002.

Nustendi 28 tablets: EU/1/20/1424/002. MA Holder: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany. Further information available on request from Daiichi Sankyo Ireland Ltd. D09 YF97. Telephone: (01) 489 3000. Fax: (01) 489 3033. Email: medinfo@daiichi-sankyo.ie Date of Preparation: May 2024 JOB ID: IE/BIL/05/24/0004 ▼ These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information.

Reporting suspected adverse reactions after authorization of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the HPRA Pharmacovigilance Website: www.hpra.ie. Adverse events or a product complaint about a Daiichi Sankyo medicine can also be directly reported to Daiichi Sankyo Ireland Ltd. D09 YF97 by telephone: +353 (1) 4893000

References: 1. NILEMDO®. Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/nilemdoeparproduct-information_en.pdf [Accessed August 2024].

2. NUSTENDI®. Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/nustendieparproduct-information_en.pdf [Accessed August 2024].

IE/BEM/08/24/0003 | Date of preparation: August 2024

38 Honours

Hospital Professional Honours Winners 2024 In the surroundings of Dublin Royal Convention Centre, over 550 hospital professionals and industry leaders gathered for the 2024 Hospital Professional Honours.

The Honours are the most influential and respected networking event, lauding excellence, innovation and service development; judged by key influencers including renowned respected experts. Their foundation lies in our collaboration with leading pharmaceutical companies; without whose investment and support, the event would not be possible.

Kelly Jo Eastwood, Editorial Director with Hospital Professional News welcomed guests stating, “Tonight is about recognizing the people who stand at the very heart of healthcare: the Consultants, Clinical Specialist Teams, Pharmacists, Technicians and much more, who tirelessly work to improve the lives of others.

You are the lifeblood of Ireland’s hospitals, and it is your expertise, compassion, and resilience that allow Ireland to achieve the highest standards of care, day after day.

“Each of you here tonight has played a vital role in advancing healthcare—not just within these walls but across the island at large. In a time when healthcare faces unprecedented challenges, you continue to rise above, showing strength, innovation, and an unyielding dedication to your patients. Your contributions have not only saved lives but

also transformed them, giving countless families hope and a brighter future.

“We are here to celebrate more than just achievements; we are here to honour the passion behind them. The long hours, the difficult decisions, the moments of triumph, and sometimes heartbreak—all of which are driven by a deep commitment to the wellbeing of others. Your work reminds us that healthcare is not just a profession, it is a calling.

“As we recognise your extraordinary contributions today, let this also be a moment to reflect on the critical role you play in shaping the future of healthcare. Your innovations, your compassion, and your unwavering dedication to excellence set the standard for others to follow.

“I would like to take a moment to express our deepest gratitude to the sponsors who have made this evening possible. Without your generous support, tonight’s event would not have been realized, and for that, we owe you our sincerest thanks.

Our sponsors are more than just contributors; they are true partners in our mission to advance healthcare.”

We were overwhelmed with both the quantity and quality of the entries this year, making it an extremely difficult task for our esteemed judging panel. The winners are featured over the next pages.

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

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 licensed1,3

Evaluated for safety over 52 weeks1

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

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.

40 Honours

Grünenthal Advancing the Standard of Care in Pain Management The Grünenthal Advancing the Standard of Care in Pain Management category was hotly contested with six finalists. The accolade went to the team at Beaumont Hospital iPainCentre.

Beaumont Hospital is the only Pain Service in the RCSI Hospital Group and with a catchment area of nearly 1 million people, the largest catchment area of the 17 public funded Pain Services in the country. The team recognised that the model of care for patients with lower back pain (LBP) was not optimal, and a new approach to managing patients with low back pain was required. Based on the teams experience, they applied to Sláintcare for funding to reform the way low back pain is managed by their hospital pain service and to explore if the multi-disciplinary hospital pain team can work with the community based services to improve access to care and patient outcomes.

The team aim to reduce the burden of pain and disability by supporting patients to remain in employment, continue with social interactions, and every day activities. They are the first Pain Service in Ireland to reach out into the community to

Winners of the Grünenthal Advancing the Standard of Care in Pain Management Honour Professor David Moore and team from Beaumont Hospital iPainCentre with Hilary Baseley, Head of Commercial Excellence, UK, Ireland & Nordics (Norway, Denmark, Sweden, Finland), Grunenthal

integrate services for the benefit of the patient and have called this new service the iPainCentre at Beaumont Hospital.

Dr David Moore, Consultant in Pain Medicine and Team Lead stated, “Our project is something that we feel is very important – introducing a community pain team into North

Dublin and trying to improve the practice of pain management. This is a Slaintecare funded project and so we also want to thank them for the support.

“Being able to witness tonight all the projects and innovations being carried out by professionals and teams across Ireland has been fantastic and really serves to raise the profile of all this work across a number of specialties. This is a wonderful opportunity for us as a Pain Team to present our project and even better that it has been valued and won.”

Professor David Moore and team from Beaumont Hospital iPainCentre with Hilary Baseley, Head of Commercial Excellence, UK, Ireland & Nordics (Norway, Denmark, Sweden, Finland), Grünenthal Hilary Baseley, Head of Commercial Excellence, UK, Ireland & Nordics, Grünenthal, said, “We are delighted to sponsor this Honour for raising the standard of care in pain management. It demonstrates pain management at its absolute best and recognises all of those who work in this field.

“It is a real privilege to present this Honour. I would like to congratulate all of the finalists and of course, Beaumont Hospital iPainCentre.”

Hospital Professional

ONOURS 2024 OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

Adverse events should be reported to www.hpra.ie Adverse events should also be reported to Grünenthal Pharma Ltd Tel: +44 (0)870 351 8960 medicalinformationie@grunenthal.com

FURTHER INFORMATION AVAILABLE FROM: Grünenthal Pharma Ltd. 4045 Kingswood Road, Citywest Business Park, Co. Dublin.

FOR FULL PRESCRIBING INFORMATION REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS. M-ALL-IE-02-23-0001 – February 2023

42 Honours

Excellence in Patient Safety 2024

Hospital Professional

ONOURS 2024

The Excellence in Patient Safety Honour for 2024 went to the Senior Antimicrobial Stewardship Pharmacists at Mayo University Hospital.

The Antimicrobial Stewardship (AMS) pharmacists in MUH in collaboration with the microbiologists and immunologists in GUH have developed a penicillin allergy-delabelling programme.

Education on this programme was provided to pharmacists in MUH and to medics and nursing within the hospital. The penicillin allergy delabelling process is crucial for reassessing the accuracy of a penicillin allergy label. These steps provide valuable insights into the nature, severity, and appropriateness of the reported allergy.

The AMS pharmacists in collaboration with other team members designed a comprehensive questionnaire/ consent forms for patients to complete and also referral and communication letters for the patients GPs and the immunology service in GUH.

Rose Cafferty and Marie Ronan, Senior Antimicrobial Stewardship Pharmacists at Mayo University Hospital with Martina Phelan, CEO, Chronic Pain Ireland

Rose Cafferty and Marie Ronan, Senior Antimicrobial Stewardship Pharmacists at Mayo University Hospital, winners of the Excellence in Patient Safety 2024

Communication stickers were also designed for patient’s medical notes and standard operating procedures wrote and implemented. Since the service formally began in July 2023, the AMS pharmacists have reviewed over 70 patients that meet the criteria for penicillin allergy delabelling review. 33% of patients were delabelled in MUH by the AMS pharmacists on history taking and medication record review alone, demonstrating the vital roles that these have in the process of delabelling penicillin allergy. 26% of patients have been referred to our colleagues in the immunology department in GUH. Marie Ronan who spoke on behalf of the team said, “Patient safety is at the core of everything we do, guiding every decision and action we take. It’s more than just

a priority—it’s a responsibility we uphold with the utmost dedication.

“We are absolutely thrilled to win this Honour, as it highlights our unwavering commitment to ensuring the safety and wellbeing of those we care for. This achievement is a reflection of true teamwork; it was a collaborative effort where every member of the team played a vital role. Each individual’s contributions were essential to the success of this project, and together, we worked tirelessly to make a real impact. We couldn't be more proud of what we've accomplished as a team.”

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Honours 43

MSD Excellence in Oncology Initiative The UHL Lymphoedema Early Detection Team won the MSD Excellence in Oncology Initiative for their innovative project which aimed “to introduce a lymphoedema early detection service in UHL oncology unit for all breast and gynae patients who have had surgery and/ or radiation to reduce the incidence and impact of lymphoedema in Ireland. The findings from the pilot will be used to support future funding for similar services in all oncology centres.”

Breast cancer Related Lymphoedema (BCLR) is a well-known side effect of breast cancer treatments including surgery, chemotherapy, radiation therapy and endocrine therapies.

Damage or overload to the lymphatics predisposes high-risk cohorts to the development of arm lymphoedema.

Kathy Nugent, University Hospital Limerick Lymphoedema Early Detection Team said, “Our goal has always been to make a real difference for patients.

Lymphoedema is still a relatively new diagnosis for many, and understanding and managing it can be a challenge. That’s why our service is so crucial—it's focused on early detection and preventing the condition from progressing.

“We are absolutely thrilled and honoured to receive this recognition, as it brings greater

Shirley Real and Kathy Nugent, University Hospital Limerick Lymphoedema Early Detection Team with Fergal Scully, Pharmaceutical Manager at MSD

awareness to both our service and the condition itself. If we can help patients become aware of the support available, we can truly improve their quality of life and make a lasting impact."

Sinead Gibbons, Communications Manager, MSD said, “MSD are proud to sponsor the Excellence

Winners of the MSD Excellence in Oncology Initiative 2024 Sinead Cobbe, Shirley Real and Kathy Nugent, University Hospital Limerick Lymphoedema Early Detection Team with Fergal Scully, Pharmaceutical Manager at MSD

in Oncology Initiative 2024.

We recognise and applaud the essential role that oncology healthcare professionals and their teams play every day in helping to improve oncology services and care for people with cancer in Ireland and we would like to congratulate all of the nominees for their tireless dedication.

seven sites in Tipperary, Cork, Carlow, Dunboyne, and Dublin.

MSD colleagues have the privilege to work with the entire cancer community - advocacy partners, health care providers, governments and industry colleagues - all who share our mission to extend and improve the lives of people with cancer.

“Established in Ireland over 50 years ago, MSD is one of the country’s leading healthcare companies. We have a dynamic and diverse team of over 3,000 employees currently across

“We would like to thank all Healthcare Professional partners for their unwavering dedication to enhancing patient care. Thank you to HPN for organising a great event.”

Hospital Professional

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44 Honours

Excellence in Respiratory

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ONOURS 2024

The Excellence in Respiratory was won by Galway University Hospitals & Galway City Integrated Care Respiratory Team.

This new respiratory team was implemented under the Enhanced Community Care (ECC) programme. A significant aspect of the ECC rollout is the establishment of the Integrated Care Programme for the Prevention and Management of Chronic Disease (ICPCD).

Under this programme, the newly formed team created the ‘OneStop-Shop’ Respiratory Clinic for patients with suspected or confirmed asthma or COPD. This ‘one-stop-shop’ model of respiratory specialist care is in line with Slaintecare, providing holistic specialist care close to the patient’s home in a manner that is most convenient to them i.e. one place, on the one day where they get everything from the diagnosis right through to treatment, management and an ongoing care plan.

Sinead Walsh, Galway University Hospitals & Galway City Integrated Care Respiratory Team, winner of the Excellence in Respiratory Honour: pictured with presenter, Mary McDonald, Patient Services Manager, Asthma Society Ireland

Dr Sinead Walsh said, “It’s amazing for myself and my team to win this category. We are a relatively new team, formed as part of the Enhanced Community Care Greater Care Programme for Chronic Disease. We are a multidisciplinary team that came together to design a one-stop shop for patients to deliver excellence in respiratory care for patients with asthma and COPD in Ireland.

Sinead Walsh, Galway University Hospitals & Galway City Integrated Care Respiratory Team, winner of the Excellence in Respiratory Honour: pictured with presenter, Mary McDonald, Patient Services Manager, Asthma Society Ireland

“These Honours are so important to the hospital world because often in the media there can be a focus on the negative stories and what is wrong with the healthcare system but there is actually really good things happening in the world of healthcare everyday.

“To have an Honours ceremony like this highlights this good work being carried out by teams and professionals for their patients every day.”

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Honours 45 Galapagos Biotech Ltd, an Alfasigma Company, Multidisciplinary Team of the Year 2024 The Galapagos Biotech Ltd, an Alfasigma Company, Multidisciplinary Team of the Year 2024 went to the Rapid Access Frailty Team at Midland Regional Hospital Tullamore.

The RAFT (Rapid Access Frailty Team) at Midland Regional Hospital Tullamore is a team of healthcare professionals specialising in the care of older people in the Emergency Dept (ED). The team focus on people with frailty over the age of 75 years attending the ED. The RAFT initiative was set up in 2016 as a joint initiative with ED and the Geriatric department at MRHT to address the increasing presentations of frail patients to the ED. The primary goal was enhanced frailty assessments in ED with discharge to Community Reablement teams. Following a success pilot in 2016, a business application followed and the team has evolved since then.

Dr Theresa Donnelly and Dr Joanna McGlynn, both Consultant Geriatrician collected the Honour.

Dr Donnelly stated, “This is a huge recognition of all the dedicated work from the staff at every hospital across Ireland and shows the ability to upskill to create a great service for their patients.”

Winners of the Galapagos Biotech Ltd, an Alfasigma company, Multidisciplinary Team of the Year 2024 the Rapid Access Frailty Team at Midland Regional Hospital Tullamore with Patrick Oliver, General Manager at Alfasigma

Patrick Oliver, General Manager at Alfasigma pictured with the winners of the Galapagos Biotech Ltd, an Alfasigma company, Multidisciplinary Team of the Year 2024 the Rapid Access Frailty Team at Midland Regional Hospital Tullamore

Dr McGlynn added, “Our focus is always on the patients. But it is also fantastic for us to realise that what we are doing is helping people and helping our patients and to receive that appreciation for our own team is a great motivation to continue what we are doing Patrick Oliver, General Manager with Alfasigma said, “We are delighted to be here tonight to support all the finalists and their team all the work they do for patients. We are delighted to be here to support them and to celebrate with them.

“We were keen to support this category specifically as we recognised within our own organisation the importance of collaborative working.

“We know that across the healthcare sector, it continues to be a complex and relentlessly changing environment. Tonight’s Honours ceremony are a testament to the outstanding commitment, hard-work and tenacity teams have shown on behalf of the patients and communities that they serve.”

Hospital Professional

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46 Honours

Consultant-Led Team of the Year

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ONOURS 2024

Consultant-Led Team of the Year went to the Pain Management Service at Croom Orthopaedic Hospital, ULHG for 2024.

Each team member here is recognised and appreciated for the individual contribution as well as the team-based contribution to patient care and treatment outcome. There is a shared team goal and mission which fosters a sense of purpose and encompasses unity among team members. Monthly MDT meetings, multidisciplinary patient feedback and open-door policy among the team facilitates open and transparent communication.

Team members are encouraged and empowered to share views and ideas to care as well as being supported in shared decision making for the benefit of staff, the patients, the service and the community as a whole.

The Pain Management Centre is the first dedicated Pain Management Unit in Ireland. Since its establishment, the team have strived to continuously develop and expand on services provided to ensure the delivery of the best care. Waiting lists have reduced from 49 months to 12 weeks from referral to review for routine patients. Time to pain intervention

Winners of the Consultant-Led Hospital Team of the Year 2024 Professor Dominic Harmon and Team at Pain Management Service, Croom Orthopaedic Hospital, ULHG with presenter Professor William Gallagher, UCD School of Biomolecular and Biomedical Science

Pictured Left to Right are Winner(s) of the Consultant-Led Hospital Team of the Year 2024: Prof Dominic Harmon and Team at Pain Management Service, Croom Orthopaedic Hospital, ULHG with presenter Professor William Gallagher, UCD School of Biomolecular and Biomedical Science. Photo: Aidan Oliver Photography

has also reduced from 60 weeks to 12 weeks from review time with the ability to facilitate larger lists. Emergency procedures can now be facilitated in day-theatre immediately following assessment in outpatient clinics. Points of contact for the patient have been successfully reduced to a minimum of 1 and this has allowed for a larger number of patients to be reviewed thus reducing wait times.

Commenting on receiving the Honour, Professor Dominic Harmon Consultant in Pain Medicine and Anaesthesia in Limerick University Hospitals told us, “This is a fantastic accolade. For us it’s all about working together.

"Within the healthcare profession, our mission is always to grow and deliver the highest quality care for our patients. As a team, we are deeply honoured and grateful to receive this recognition. I am confident that, as a dedicated and united group, we will continue to work together, pushing forward and striving for excellence in everything we do.”

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

Honours 47 Fresenius Kabi Innovation in Aseptic Compounding The Pharmacy Aseptic Compounding Unit Team at St James’s Hospital celebrated winning the Fresenius Kabi Innovation in Aseptic Compounding Honour, 2024.

With projected increases in demand in future years, the pharmacy department at St James’s Hospital undertook a scoping exercise to investigate the potential impact of Robotic Compounding would have on services. After completing thorough research and on procurement of a Compounding Robot the team have observed huge benefits including an improved patient experience, service resilience and improved quality assurance.

They are the first hospital in Ireland to successfully introduce this innovative technology to their Aseptic Compounding Unit. The benefits to patients, pharmacy staff and healthcare colleagues have been immense.

Gail Melanophy said on behalf of the ACU Team, “We are absolutely delighted to win this category, as it serves as a testament to the hard work, dedication, and skill of our aseptic compounding team. Every day, they commit themselves to delivering high-quality, precise, and safe treatments, ensuring that patients receive the best care possible. This Honour is not just recognition of their technical expertise, but also of their unwavering commitment to excellence, even in the most challenging circumstances.

“Their teamwork and passion truly make a difference, and we couldn't be prouder to see their efforts acknowledged in such a meaningful way.”

Conor Sadlier, National Sales Manager Pharma with Fresenius Kabi Ltd said, “Fresenius Kabi is

Conor Sadlier, National Sales Manager Pharma at Fresenius Kabi Ireland pictured with the Pharmacy Aseptic Compounding Unit Team at St James’s Hospital, winners of the Fresenius Kabi Innovation in Aseptic Compounding Honour

Fresenius Kabi Innovation in Aseptic Compounding Honour 2024 winners, the Pharmacy Aseptic Compounding Unit Team at St James’s Hospital with Conor Sadlier, National Sales Manager Pharma at Fresenius Kabi Ireland a global healthcare company that specialises in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition.

Our products and services are used to help care for critically and chronically ill patients.

“Fresenius Kabi is excited and honoured to sponsor the HPN honour for ‘Innovation in Aseptic Compounding.’

“Aseptic compounding is a key part of the delivery of safe medical treatments to cancer patients across the country of

Ireland. The continued innovation of all nominees in this category is crucial in the fight against cancer. Innovations in aseptic compounding create safer working conditions for our health care professionals and ultimately help to improve the quality of medicines for patients across the country.

“I want to congratulate all the nominees for helping to highlight the amazing work being done in compounding units across Ireland.”

Hospital Professional

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48 Honours

Young Hospital Pharmacist of the Year 2024

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ONOURS 2024

Showcasing herself as a Rising Star in the profession, Jayne Tuthill from Mater Misericordiae University Hospital won the Young Hospital Pharmacist of the Year 2024.

Jayne is currently working in a Chief II project manager post, leading implementation of the National Cancer Information System (NCIS) at MMUH. She has managed the Drug Safety Service for over a year and consistently delivered an excellent service output. Jayne has provided crucial support to the Clinical Pharmacy Service and has progressed a number of pharmacy services including the psychiatry ward service and the drug safety service. She has implemented a number of high-risk drug audits and risk management initiatives throughout the hospital.

Jayne has worked in the MMUH since 2018 when she qualified as a pharmacist and has gained extensive experience across pharmacy services and a strong clinical background.

Jayne has been a dedicated

Young Hospital Pharmacist of the Year 2024 Jayne Tuthill, Mater Misericordiae University Hospital with presenter Marguerite Vaughan, Dispensary Manager, Tallaght University Hospital

and trust-worthy colleague with excellent attention to detail and follow-up. She progressed to senior pharmacist grade in 2021, working in the Medicines information and Clinical Pharmacy services. She was appointed into an Acting Chief II post in September 2022 before securing a Chief II post in Jan 2024.

Jayne said after collecting her accolade, “It means a lot to me personally to win this category as a reflection of my hard work.

But also, it’s a reflection of the wonderful team I work with in the

2019 winner of the Young Hospital Pharmacist of the Year presents the 2024 Honour to Jayne Tuthill, Mater Misericordiae University Hospital

Mater Misericordiae University Hospital and the progressive pharmacy department that we have. Being patient-focused and delivering excellence in pharmacy is always our priority.

“It’s truly fantastic to have an event such as this which allows us all to take a step back and appreciate how far you have come and your achievements whilst celebrating with your team around you. My team are the people that support me every day and help me to reach my goals in work.”

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

Honours 49 Medisource Hospital Pharmacy Technician of the Year 2024 The Medisource Hospital Pharmacy Technician accolade was scooped on the night by Caroline Monaghan, Tallaght University Hospital.

Caroline Monahan is a hardworking, reliable and enthusiastic team player who strives for excellence in all her endeavours.

As a Senior Pharmaceutical Technician and Medicine Management Technician Supervisor, Caroline has spent the last 20 years championing the expanding role of the hospital technician and has demonstrated exceptional leadership in rolling out innovative technician services in Tallaght University Hospital (TUH).

Caroline said, "I am truly honoured to receive this title. It’s also incredibly gratifying to see Hospital Pharmacy Technicians being recognised as an integral part of the wider healthcare team. The Hospital Professional Honours are a wonderful way to highlight the incredible work being done by Ireland's healthcare professionals every day. These s also create a valuable opportunity for us to exchange ideas and continue learning from one another.

“If there’s one key message I’d like to share, it’s this: let’s stay focused and keep pushing for what we believe in—always striving to deliver the best care and to advance our profession."

Winner of the Medisource Hospital Pharmacy Technician of the Year 2024 Caroline Monahan, Tallaght University Hospital with Pat Tehan, Managing Director of Medisource Pat Tehan, Managing Director of Medisource added, “Medisource are delighted to sponsor the HPN Hospital Pharmacy Technician of the Year Honour again this year.

“Established in 2004 and celebrating our 20th anniversary on the weekend of the Honours, Medisource continues to be a wholly Irish owned company with 30 experienced staff, with our mission to source and supply exempt medicines to all parts within the Irish healthcare system. We work with a wide range of organisations, including multinationals to niche biotech companies around the world to source and deliver urgent medicines to patients in Ireland.

“Our continued commitment is an emphasis on personal communication to ensure that medicines are sourced and delivered within the required timeframe and that such sourcing is done only through verified and legitimate distribution channels

Winner of the Medisource Hospital Pharmacy Technician of the Year 2024 Caroline Monahan, Tallaght University Hospital with Pat Tehan, Managing Director of Medisource

within regulations. We offer a global reach and commit to significant local stockholding so that your patient doesn’t have to suffer a break in treatment.

“We invest heavily in our human resources so that we can provide live information through one to one communications.”

Hospital Professional

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50 Honours

GSK ViiV Infectious Diseases Project of the Year Dr Peter Barrett and the Health Protection Team in the Department of Public Health, Cork & Kerry won the Honour for the GSK ViiV Infectious Diseases Project of the Year category.

The team recognised that their internal and external communication mechanisms needed to become more robust and streamlined; most new cases and outbreaks of infectious diseases were being notified electronically to the Department, rather than via the more traditional mechanisms of paper/postage.

More clinical staff were required to respond to the additional volume and complexity of notifications across the region, yet they needed a clear structure to ensure that high-priority strategic/prevention work could continue to progress in Cork & Kerry, rather than allocating all of limited clinical resources to the acute ‘reactive’ response.

An Acute Health Protection Duty Room was developed at the end of 2022 to provide a more robust model of delivering the acute public health response to new cases and outbreaks of infectious disease. This new model of service delivery was informed by international health protection experience obtained by Dr. Barrett during Higher Specialist Training in Public Health Medicine, as well as by evidence reviews of alternative models of service delivery undertaken by the MDT in HSE South West.

The objectives of this initiative align with the HSE Health Protection Strategy 2022-2027.

Dr Barrett said, “Receiving this Honour means a great deal to our

team. In public health we have been through a pretty tumultuous time over the last few years.

Obviously, in trying to manage a pandemic, our speciality has also gone through a lot of reform and restructuring and so it has been a busy time and a time of a lot of change for our staff. This is acknowledgement of the high quality service that our staff in the Department of Public Health South

Dr Peter Barrett and the Health Protection Team in the Department of Public Health, Cork & Kerry, winners of the GSK ViiV Infectious Diseases Project of the Year 2024 presented by Youssef Youssef, Business Unit Head, HIV, GSK ViiV Ireland

Youssef Youssef, Business Unit Head, HIV, GSK ViiV Ireland with Dr Peter Barrett and the Health Protection Team in the Department of Public Health, Cork & Kerry, winners of the GSK ViiV Infectious Diseases Project of the Year 2024 West are continuing to provide for the population of Cork and Kerry.”

approaches to enhance the field of infectious disease.

Youssef Youssef, Business Unit Head with GSK Viiv said, “The GSK × ViiV team are honoured to sponsor the Infectious Diseases Project of the Year for 2024, recognising exceptional achievements from our remarkable hospital professionals here in Ireland.

“Our commitment to sponsoring this Honour stems from our focus of being Ambitious for Patients, Accountable for Impact, and Doing the Right Thing, driven from our purpose of uniting science, talent & technology to get ahead of disease together.

“Infectious Disease present ongoing challenges globally, putting increased pressure on our healthcare system and its staff. This demands dedication, innovative solutions and research to find new

“This is where we believe this Honour gives our healthcare professionals the recognition they deserve, and an opportunity to celebrate those key contributions that are directly impacting patients and enhancing care in the field.”

Hospital Professional

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Honours 51

Viatris Excellence in Cardiovascular Initiative Beaumont Cardiac Rehabilitation Team won the Viatris Excellence in Cardiovascular Initiative for 2024.

Beaumont Hospital’s Cardiology Department provides cardiac patients with the most comprehensive Cardiac Rehabilitation (CR) programme in Ireland. As well as delivering the largest annual throughput of patients, the department is internationally recognised as a centre of excellence for CR. Beaumont Hospital is the first and only CR centre in Ireland and the UK to achieve international accreditation in CR and secondary prevention.

Patients are provided with an exceptionally high concentration of multi-disciplinary expertise overseen by an actively involved Medical Director (Consultant Cardiologist), and each member of the multi-disciplinary team (MDT) has recognised expertise in their respective field. This seamless CR service benefits from close cooperation and communication between MDT members, allowing patients to achieve optimal health.

Accepting the Honour team members Alison Cahill, Sadhdbh ni Cheallaigh and Lorna Carroll told us, “We are thrilled and delighted, and feel very privileged to accept this Honour here tonight because we are accepting it collectively on behalf of our entire team of staff who deliver first class service to patients.

“Through all our team members skills we are able to offer a well-rounded service and help

get patients back on the road to recovery and to full health.

For those hospital professionals such as in our team who work constantly on the front-line, we are always striving for a better service that will benefit our patients, engage with our patients and which is all about giving our patients the best opportunity and the easiest access to help them stay well and out of hospital.

Winners of the Viatris Excellence in Cardiovascular Initiative Honour 2024, Beaumont Cardiac Rehabilitation Team with Niamh Brennan, Marketing Lead at Viatris and Host Marty Whelan

“To get recognition for that work is our sign to keep going.”

Enis Otuk, Country Manager Ireland, Viatris said, “Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both, to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale.

“In Ireland, we have over 1,600 dedicated colleagues across five sites who work to provide access to medicines, develop innovative solutions and improve healthcare for patients.

Winners of the Viatris Excellence in Cardiovascular Initiative Honour 2024, Beaumont Cardiac Rehabilitation Team with Niamh Brennan, Marketing Lead at Viatris “As the Country Manager for Ireland, it is my great pleasure to congratulate the finalists of the Viatris Excellence in Cardiovascular Initiative Honour 2024.

“It is wonderful to showcase the commitment of cardiovascular healthcare professionals and teams in Ireland. This Honour recognises the pivotal role that these professionals play in driving excellence through innovation in cardiovascular services and care for their patients.

“Thank you all for your ongoing dedication to patients across Ireland.”

Hospital Professional

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Pharmasource Hospital Pharmacist of the Year 2024 The highly contended Pharmasource Hospital Pharmacist of the Year title was won by Darren Walsh of University Hospital Waterford.

Darren’s role is a unique one within oncology in Ireland, breaking barriers for pharmacy practice.

His versatility as a pharmacist has been shown by him stepping in to cover roster gaps in a care of the elderly and acute stroke ward for a number of months this year. He has shown leadership in advancing pharmacy practice, teamwork as an integral member of a diverse MDT and a commitment to pharmacy as a profession mentoring and teaching students, pharmacists, and pharmacy technicians.

Darren said after collecting his Honour, “These Honours present a fantastic opportunity for us as hospital workers to receive the recognition for the work that we do. Often we work in a tough environment, and see a lot of difficult cases and that can takes its toll. To be recognised by your peers is extremely rewarding and justifies the work that we do; we can put in a lot of hours both inside and outside of the work setting.

“I am accepting this Honour for my work in our Geriatric Oncology Clinic in University Hospital Waterford, which is the only one of its kind in the country.

Within this setting I work with a multidisciplinary team led by Dr Anna Horgan, who is such a pioneer of hospital pharmacists involvement within the MDT and she has really promoted my role

Pharmasource Hospital Pharmacist of the Year 2024 Darren Walsh, University Hospital Waterford with Emma Malone, Pharmasource Business Unit Director so this is fantastic recognition of her efforts. Also for my pharmacy department, who have created the time and space to allow me to carry out my work within the clinic, their support has also led to me collecting this Honour tonight.”

Emma Malone, Pharmasource Business Unit Director said, “Pharmasource are delighted to sponsor the Hospital Pharmacist of the Year 2024.

“This Honour is a testament to the unwavering commitment and professionalism displayed in the face of ever-evolving healthcare challenges. In Ireland we are seeing an expanding role for pharmacists within the population where leadership and evolution will be paramount.

“Part of Uniphar and Ireland’s largest unlicensed medicine supplier, Pharmasource understand the real-life challenges faced daily in hospitals around the country. Our dedicated team of pharmacy technicians are on hand to procure unlicensed, out-of-stock, and difficult to source medicines. The team work

tirelessly to improve our service offering and our product range to help you in responding to market shortages or sourcing requests.

“The foundation of Pharmasource is putting the patient first by helping to ensure access to essential medicines and healthcare products. We are thrilled to work with so many dedicated experts in hospitals around the country every day, who share these values.

“Pharmacists can have a profound impact on the lives and well-being of their patients from optimizing medication therapies to implementing cutting-edge technology, and all that is in between. We are delighted to celebrate excellence and dedication in the field of pharmacy, and to recognise the outstanding contribution of hospital pharmacists.”

Hospital Professional

Pharmasource Hospital Pharmacist of the Year 2024 Darren Walsh, University Hospital Waterford with Emma Malone, Pharmasource Business Unit Director

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Honours 53 Athlone Pharmaceuticals Hospital Pharmacy Team of the Year The St James’s Hospital Pharmacy Department took home the coveted Athlone Pharmaceuticals Hospital Pharmacy Team of the Year title for 2024.

The staff working in St James’s Hospital Pharmacy department bring dynamism, energy, collegiality, and respect to their everyday activities. The result is a department that is vibrant, curious, willing to challenge the status quo whilst caring for their patients and supporting and respecting colleagues.

Daily the technicians and pharmacists, within each of their specialist area strive for excellence during their routine duties. Pharmacists, technicians and support staff work together to ensure the correct medications are prescribed and available for use, that patients understand their medicines and that all clinical staff are up to date with the relevant medicines information.

Their goal is to work with, encourage and upskill all staff so that each member of the team works to their fullest potential.

Speaking on behalf of the team, Gail Melanophy said, “We are deeply honoured to win this category, as teamwork truly reflects the core of who we are and what we stand for. Every member of our team works tirelessly, day in and day out, with one shared goal: to improve patient care. Each individual brings their unique skills and expertise to the table, and together, we create a

Barry Doyle, Head of Athlone Pharmaceuticals with the pharmacy team from the Pharmacy Department at St James’s Hospital – winners of the Athlone Pharmaceuticals Hospital Pharmacy Team of the Year

synergy that allows us to deliver the highest standard of care. We support, complement, and uplift one another, ensuring that every patient receives the best possible treatment. Winning the Team of the Year is a testament to the strength of our collaboration, and we are incredibly proud to be recognised for something that is so central to our mission.”

Barry Doyle, Head of Athlone Pharmaceuticals said, “At Athlone Pharmaceuticals, we are very proud to sponsor the ‘Hospital Pharmacy Team of the Year’

Winners of the Athlone Pharmaceuticals Hospital Pharmacy Team of the Year 2024, the Pharmacy Department at St James’s Hospital with Barry Doyle, Head of Athlone Pharmaceuticals

Honour. It is never an easy task to shortlist pharmacy teams from a cohort which demonstrate such high standards of professionalism and caring daily. It is important to support and acknowledge the teams whose exceptional efforts and dedication contribute so much to patient care.

“Congratulations to those who have been shortlisted.

“Athlone Pharmaceuticals is one of the fastest growing generic pharmaceutical companies in Ireland and is delighted to begin

our association with the 2024 Hospital Professional Honours.

Athlone Pharmaceuticals is part of the Kent-Athlone Pharma Group, working alongside our sister company Kent Pharma in the UK. “I would also like to say to all the finalists here tonight, and all the guests, thank you for the exceptional work that you do, the excellence that you demonstrate.

It is obvious here in this room this evening that there was a huge number of exceptionally talented and skilled hospital professionals in the room.”

Hospital Professional

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54 Honours

Haematology Project of the Year

Hospital Professional

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The VTE Prevention team at Bantry General Hospital won the Haematology Project of the Year Honour for 2024.

Local rates of hospital acquired VTE had exceeded the national rates. National HA-VTE rates were approximately 8 per 1000 while local HA-VTE rates are at an average of 32.2 per 1000 for 2022.

The hospital group introduced VTE risk assessments on the medication charts but this failed to reduce rates. Emer O’Sullivan and Carol Walsh undertook a Postgraduate Certificate in Quality Improvement Leadership in Healthcare in the RCPI with the goal of using the skills gained during the course to find a solution to this problem and improve care for patients attending Bantry General Hospital. The overall aim of the project was to reduce the rate of HA-VTE to zero for patients admitted to Bantry General Hospital.

Overall, this project improved the patient experience by reducing the patient’s risk of developing HA-VTE, increased LOS, post thrombotic syndrome, reoccurrence of VTE, and death.

The project remains ongoing, and is currently in the sustainability phase. Audits are performed quarterly and interventions increased if results indicate.

The QIP also has increased the awareness of the importance of empowering and education patients allowing them to become partners in their care.

Winner of the Haematology Project of the Year Eimear O’Sullivan, VTE Prevention Team at Bantry General Hospital with presenter, Ann Marie O’Neill, CEO, Thrombosis Ireland

Winner of the Haematology Project of the Year Eimear O’Sullivan, VTE Prevention Team at Bantry General Hospital with presenter, Ann Marie O’Neill, CEO, Thrombosis Ireland

Emer O’Sullivan, QPS & Risk Manager with Bantry General Hospital said, “We are absolutely delighted to receive this Honour, which acknowledges the hard work we've put in over the past few years—not just within our team, but across the wider hospital group as well.

“It’s especially important for us to recognize the dedication and effort of our team here, and it’s truly rewarding to see our small hospital in Bantry gain this welldeserved recognition.”

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

Honours 55 MedFind Solutions Innovation and Service Development

MedFind Solution’s Innovation and Service Development Honour for 2024 went to The Impact of Affirmations Cards during Pregnancy, Birth and Postnatal: A Research Study or (in short) “The Affirmation project” – from The National Maternity Hospital.

A Community Midwife in The National Maternity Hospital (NMH), upon recognising the impact of spoken affirmations for women during labour, designed a set of positive affirmation cards for pregnancy, labour and the postnatal period. She successfully pitched for funding from The NMH foundation who award small grants twice a year.

Over 800 sets of cards were distributed nationally over a six-month period in 2023. This demonstrates the transfer ability of this project not only nationally but internationally.

This project was largely successfully through the deep commitment and passion for women centred midwifery care by the team. A collective leadership style was adopted. Each team member is driven by a mutual purpose and shared vision namely to provide maternity service users with support tools to assist in a positive journey into parenthood.

Matthew Farrelly, Chief Executive Officer at MedFind Solutions presents the MedFind Solutions Innovation and Service Development Honour to Alice Hoffmeister, The Impact of Affirmation Cards During Pregnancy, Birth, and Postnatal: A Research Study, The National Maternity Hospital

Alice Hoffmeister, The Impact of Affirmation Cards During Pregnancy, Birth, and Postnatal: A Research Study, The National Maternity Hospital, winner of the MedFind Solutions Innovation and Service Development Honour 2024 with Matthew Farrelly, Chief Executive Officer at MedFind Solutions Alice Hoffmeister, The National Maternity Hospital commented, “This means so much to me and to the wider team. It truly is a validation of all the hard work that has gone into promoting a positive birth experience for women.

“These Honours are so important to recognise the work healthcare professionals do and encourage continuous improvement in services.

“It is important to acknowledge that no idea is too small and we should all be making the best use of our supports in the hospital.

Together we will be able to strive forward and make the best difference to patient care.”

Sandra Cullen, Hospital Sales Manager, MedFind Solutions also stated, “Established and headquartered in Ireland, MedFind Solutions is a full service, leading pharmaceutical support, and services partner.

“Specialising in the procurement and supply of exempt medicinal products and licensed medicines, MedFind covers all therapeutic areas. From our Aseptic compounding service to the supply of critical care antidotes, we engage with our Hospital Pharmacy colleagues daily, ensuring that every patient receives the right medicine, at the right time, in a fully compliant manner.

“The combination of MedFind’ s EU and UK footprint also means they are strategically placed to offer access across geographies and mitigate against potential supply chain issues from our Dublin and London offices.

“The combination of a highquality service level, a diverse and strong portfolio and competitive pricing adds significant value to MedFinds’ customer base according to Hospital Sales Manager, Sandra Cullen: “Getting

the right medications to the patients who need them most is at the core of everything we do in MedFind,” explains Sandra.

“We’ve built an incredibly experienced team who have a wealth of knowledge behind them, but we have also kept the business agile so that we can adapt swiftly to the ever-changing patient requirements. We believe in closing the gap in patient access for effective medicines and niche therapies.”

Hospital Professional

ONOURS 2024 HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

56 Honours

Honours Red Carpet Over 550 hospital professionals and industry leaders were in attendance as winners across 15 categories were announced at the annual Hospital Professional Honours.

Each year Hospital Professional News, Ireland’s only independent monthly publication for hospital professionals, celebrates and acknowledges the achievements of teams and individuals within the profession.

The Honours took place on Saturday, September 14th; hosted

by Marty Whelan, the Honours ceremony took place in the Radisson Blu Hotel, Dublin.

The Hospital Professional Honours recognise the achievements of individuals and teams working in the hospital sector; their dedication and innovation which positions the profession at the forefront of healthcare, improving the lives of people across the country.

Pictured are some of those who attended.

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5 1. Caroline Conlon and Liz Devlin, Medisource 2. Matthew Coleman, Margo Keating, Claire Hamilton and Patrick Oliver from Galapagos Biotech Ltd, an Alfasigma Company 3. All smiles at the Hospital Professional Honours 2024 4. Pictured are the team from Blackrock Clinic 5. Emma Malone, Eimear McEnteggart and Alice Murphy, Pharmasource with and guests from Sligo Hospital 6. Galway University Hospital guests OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

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1. The team from Blackrock Health Hermitage Clinic 2. Lorna and Colin Galvin 3. University Hospital Waterford Aseptic Compounding Team 4. Katie Butler and Kevin Fahy, St James’s Hospital 5. The Cardiothoracic Team from Galway University Hospital 6. Eileen Dineenan and Claire Byrne, Grünenthal HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

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1. ​Dr Laura and Michael Sahm 2. Andrea Burke, Midland Regional Hospital Portlaoise with Honours guests 3. Christina Donnelly, Martina Phelan and Niamh Walsh, Chronic Pain Ireland 4. Pictured are the Aseptic Team from St James’s Hospital 5. Alice Griffin and Professor Jonathon Lyne, Beacon Hospital 6. Martyna and Joe Egan, MyFeet.ie with guests OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

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1: Alice Hoffmeister and Tim Nugent, National Maternity Hospital 2. Hilary Baseley, Claire Byrne and Elaine Dinneenan, Gruenthal 3. The team from Tallaght University Hospital 4. Ninv and Sangeetha pictured from Blackrock Health Hermitage Clinic 5. Barbara Kelly and Jade Donovan, Excel Recruitment 6. Roisin Byrne, Paulina Zagrabsha, Tara Hayden and Catherine Kelly, St Luke’s Hospital HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

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6 1. The team from Mater Misericordiae University Hospital 2. The team from Tallaght University Hospital 3. Pictured from the University Hospital limerick Pharmacy Department 4. Munaza Wajahat, Dr Muhammed Raheel Khan, from Tallaght University Hospital with Ciara Keany Sheehan and Patrice Kearney Sheehan, St James’s Hospital Testicular Team 5. Liam Townsend and team from St James’s Hospital and University Hospital Galway 6. The pharmacy team from University Hospital Limerick 7. The team from Viatris

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Clinical R&D 61 ASTELLAS INITIATES PHASE 3 CLINICAL STUDY OF FEZOLINETANT FOR VMS IN WOMEN WITH BREAST CANCER RECEIVING ADJUVANT ENDOCRINE THERAPY Astellas Pharma has recently announced dosing of the first patient in the HIGHLIGHT 1™ Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy.

Breast cancer is the most common cancer in women globally, with approximately 2.3 million new cases in 2022. Hot flashes and night sweats, also known as VMS, are recognized as the most prominent side effect of adjuvant endocrine therapies used in the treatment of breast cancer. Approximately 77% of breast cancers can be treated with adjuvant endocrine therapies, most commonly tamoxifen and aromatase inhibitors, and up to 97% of breast cancer patients experience hot flashes or night sweats.

Marci English, Vice President, Head of BioPharma Development, Astellas “VMS can adversely affect quality of life, as well as compliance with treatment, for patients with breast cancer taking adjuvant endocrine therapy. We are excited to get the HIGHLIGHT 1 study underway, as currently there are no approved treatments for moderate to severe VMS that can be used by these patients.”

NEED TO SUPPORT FUTURE TECHNOLOGIES IN SURGERY A new report from the Royal College of Surgeons in Ireland (RCSI) has heard from surgeons across a range of specialties and training stages about how technology is changing surgery.

The study explores the current technology-enabled trends that are

enabling surgery and improving patients’ lives and also what is needed to ensure surgeons can use emerging and new technologies into the future.

The New Technologies for Future of Surgery in Ireland RCSI Working Group Report 2024 engaged with 30 surgeons, surgical trainees and researchers across a range of disciplines.

Their responses identified biomaterials, robotics and digital platforms for collaboration as the most important current technologies for surgery, followed by data analytics and 3D-reconstructive models for planning operations.

Looking forward, the study participants believe that artificial intelligence, wearables, virtual/ augmented-reality displays and genomic analysis will be of great importance for surgery over the next decade.

Based on the study, surgeons are generally excited by the opportunities for more personalised and less invasive surgeries and across the board their interest in new technologies is being driven by the desire to improve patient care and outcomes.

However, the study respondents also highlighted potential challenges such as the steep learning curve for surgeons, data security and overreliance on or inappropriate use of technology. They also conveyed general concern about the ability of surgeons and their units to make best use of new/ disruptive technologies.

L-R Ms Debbie Killeen, Professor Deborah McNamara, Mr Kieran Ryan, Professor Ronan Cahill, Mr Ashokkumar Singarelvu, Professor Laura Viani, Dr Alice Moynihan

The majority of study participants believe that such technologies in surgery require a clear national strategy involving all stakeholders including the public, shared procurement considerations and they were concerned at current levels of investment.

Professor Ronan Cahill, RCSI Council Member and Chair of the Committee on New Technologies in Surgery in Ireland, described the work in the report as a first step in engagement. “Like everywhere else in society, technology is embedded in surgery with increasing capability coming onstream,” said Professor Cahill.

“With advances in computing power alongside improved patient diagnostics, including imaging and genomic analysis, the role of technology in surgery is set to accelerate further into the 21st century,” he added. “Such capabilities require consideration of training, working, implementation and administration.”

The New Technologies for Future of Surgery in Ireland RCSI Working Group Report 2024 also features a series of invited perspectives on surgical training and education, environmental impact, integrating innovation, the need for surgeons to adapt throughout their career and the medtech industry.

RCSI President Professor Deborah McNamara welcomed the insights expressed by surgeons in Ireland on new technologies for surgical practice. “Technologies are rapidly changing the landscape of surgery and RCSI has a leading role to play to ensure that our surgeons can practise, innovate and improve patient outcomes and lives in this fast-changing environment,” she said.

“The findings and insights from this report will help RCSI to shape our training programmes, to ensure we meet the needs of our current and future surgeons.”

The report was commissioned by immediate past president of RCSI, Professor Laura Viani during her term of office. The initiative involved 30 participants who answered survey questions with 17 of these taking part in more indepth interviews.

IKA CALLS FOR THE INCLUSION OF CHRONIC KIDNEY DISEASE IN IRELAND’S CHRONIC DISEASE MANAGEMENT PROGRAMME The HSE's Opportunistic Case Finding (OCF) Programme report, released on 5th September 2024, highlights an urgent need to address the growing impact of Chronic Kidney Disease (CKD) in Ireland, said Colin White, National

Advocacy & Projects Manager for the Irish Kidney Association.

Following the OCF Programme report stark findings, the Irish Kidney Association (IKA) is calling for funding to be put in place to include Chronic Kidney Disease (CKD) in the Chronic Disease Management Programme (CDMP) for GPs, to ensure that vulnerable patients receive the necessary care and treatment they need. In addition, the IKA is calling for the enrolment age for the Chronic Disease Management Programme to be lowered to 18+ years for people with advanced stage CKD (stage 4 - 5) and for the Prevention Programme for people with earlier stage CKD (stages 1- 3). The enrolment age for the Chronic Disease Management Programme should also be set at 18+ for all CKD-related conditions.

The Irish Kidney Association asserts that based on domestic and international research, these measures will result in significant long-term benefits for the population’s health outcomes, reducing the burden on our healthcare system and savings to the exchequer.

The 2023 TILDA and NRO Report revealed the scale of the challenge, indicating that an estimated one in ten of the general population is living with Chronic Kidney Disease (CKD). This rises to one in seven over the age of 50, a startling 98% of whom are not aware they have it. Including a dedicated treatment pathway for people with chronic kidney disease (CKD) within the Chronic Disease Management Programme is the most logical way forward as slowing the progression of CKD is now a realistic outcome for many whilst also being the most cost-effective approach.

Chronic Kidney Disease is closely linked to cardiovascular disease, hypertension, and diabetes, all three of which are already covered by the Chronic Disease Management Programme.

Without intervention, chronic kidney disease can worsen these conditions, increasing the risks of heart attack, stroke, and heart failure, while leading to avoidable hospitalisations.

Earlier diagnosis and intervention are essential for not only stopping or slowing down the progression of kidney disease, but also to alleviate the increasing burden on the Irish health service and the economy. There is a significant legal and financial risk to the State if no action is taken to manage the progression of the disease, as patients have been identified as having CKD but follow up treatment pathways are not established.

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62 Clinical R&D Colin White, from the Irish Kidney Association stated that, “According to the report, 14.2% of those assessed through the Opportunistic Case Findings (OCF) programme which focussed only on Diabetes and Cardiovascular disease, were found to have abnormal kidney function, that is with an eGFR, glomerular filtration rate, below 60. The report identified 26,334 patients with an eGFR below 60 ml/min, the mean eGFR was 47.8 ml/min.

Whilst a history of chronic kidney disease is a reason for which GPs can do the OCF assessment, it is not currently a condition for which they can register patients on the Prevention or Treatment programmes. Hence, currently while patients with chronic kidney disease are being identified by the OCF Programme they are not eligible to be enrolled in the Treatment or Prevention Programmes. This leaves thousands of at-risk patients without necessary follow-up care.

High blood pressure is not only a cause of kidney disease, but kidney disease is also a cause of high blood pressure.

Cardiovascular disease rather than end-stage kidney disease (CKD stage 5) is the leading cause of death in people with Chronic Kidney Disease (CKD). CKD mimics an accelerated aging of the cardiovascular system.

According to an answer to a Dail question (on 22nd February 2023 pq-7216-23-colm-burke.pdf (hse. ie), the cost of providing care for patients with End Stage Kidney Disease (stage 4 and 5) in Ireland in 2022 was ¤352 million. This figure includes cost of dialysis care and transplantation care.

The HSE National Renal Office 2023 figures revealed that there are 5,275 patients in Ireland with End Stage Kidney Disease (ESKD), also referred to as Stage 5 kidney disease, who are being treated with dialysis (2,502) or a kidney transplant (2,755).

Chronic Disease Management Programme is critical to improving care, reducing long-term costs, and enhancing quality of life for patients.”

Earlier diagnosis and intervention are essential for not only stopping the growth of kidney disease, but also to alleviate the increasing burden on the Irish health service and the economy. There is a significant legal and financial risk to the State if no action is taken to manage the progression of the disease, as patients have been identified as having Chronic Kidney Disease but follow up treatment pathways are not established.

GROUNDBREAKING RESEARCH AT TYNDALL AIMS TO ELIMINATE SKIN COLOUR BIAS IN HEALTHCARE IPIC, the SFI centre for Photonics based at Tyndall National Institute (a research flagship of University College Cork) is pleased to announce that Dr Sanathana Konugolu Venkata Sekar has been awarded a European Research Council (ERC) Starting Grant. The grant, worth ¤1.58m, will support Dr Konugolu Venkata Sekar’s groundbreaking research project NOBIAS: “Novel diffuse Optical method to combat skin colour bias in non-invasive optical biomarker sensing devices”.

Skin colour bias in optical healthcare devices affects 2.2 billion people of colour worldwide.

Dr Konugolu’s project, NOBIAS, aims to develop a revolutionary Time Domain Diffuse Optical Spectroscopy (TDDOS) method to eliminate colour bias, motion artefacts and inaccuracies in optical biomarker devices such as pulse oximeters (used to measure Dr Sanathana Konugolu Venkata Sekar has been awarded ¤1.58 million from the European Research Council for his research project which aims to combat skin colour bias in healthcare

Colin White concluded, “Introducing the measures that we are calling for will require an estimated initial investment of approximately ¤350,000 for setup including Information and Communications technology, and recurring annual GP fees of an estimated ¤4.4 million.

However, It is clear this cost will be far outweighed by savings from slowing Chronic Kidney Disease progression, reducing hospital visits and interventions, fewer people needing dialysis, and improving patient outcomes and quality of life. With Chronic Kidney Disease rates continuing to rise, immediate inclusion in the

OCTOBER 2024 • HPN | HOSPITALPROFESSIONALNEWS.IE

oxygen levels in blood) and smartwatches.

This pioneering technology will address the critical need for more accurate and equitable medical diagnostics by focusing on the influence of skin pigmentation, variations in skin layer thickness, and composition across different ethnicities. The goal is to create a bias-free foundation for optical biomarker assessments that will enable a new era of accurate optical biomarker sensors for fitness and clinical bedside monitors.

The prestigious ERC Starting Grants, awarded by Europe’s leading research funding body, are designed to support emerging research leaders in building their independent teams and conducting pioneering research with the potential for significant global impact.

Speaking about his work, Dr Konugolu explains: “My goal with the NOBIAS project is to lay the foundation for the world’s first bias-free and accurate optical biomarker sensing device and our hope is that its legacy will be the gold standard for bias-free clinical and personal biomarkers sensing”.

Professor Paul Townsend, Head of Photonics, Tyndall and Director of IPIC, said: “Dr Konugolu has consistently impressed me with his passion and commitment to the generation of new ideas and knowledge, as well as his ability to commercialise those ideas to realise new medical technologies that will benefit society in the future.

This significant award confirms his outstanding potential as a worldleading biophotonics researcher, and I am confident the project will lead to new innovations that will be very impactful for the field”.

Welcoming the news, Martin O’Connell, EU Programme Manager at IPIC said: “ERC grants are among the most prestigious of any funding body worldwide and

the successful award is testament to the research excellence consistently on display on an ongoing basis in IPIC.” ¤40MILLION INNOVATIVE ARRANGEMENT TO SET A NEW STANDARD FOR PRIVATE MEDICAL CARE IN IRELAND St. Vincent’s Private Hospital (SVPH), part of St. Vincent’s Healthcare Group, has formed a 10-year Value Partnership worth ¤40m with Siemens Healthineers, the first-of-its-kind in the Republic of Ireland, setting new standards for private medical care and diagnostics. The partnership includes advanced AI technology and ensures the provision, maintenance and replacement of over 50 key radiology and cardiology assets from multiple vendors through a phased equipment replacement cycle.

With value-add elements including facility re-design as well as continuous service improvement and workforce development programmes, the partnership will enable operational efficiency and enhance delivery of patient care across Dublin.

The partnership will enable SVPH, Dublin’s largest acute private hospital, to care for patients with complex requirements in Ireland’s only integrated multihospital campus. Having a co-located public and private hospital on a single campus, SVPH shares resources, expertise and medical facilities with St. Vincent’s University Hospital, supporting care delivery for St. Vincent’s Healthcare Group which serves 470,000 patients annually. Dedicated management of the radiology and cardiology equipment, plus advanced AI technology, will further enhance cancer care at SVPH, one of the few Irish hospitals offering radiotherapy, immunotherapy, surgery, and chemotherapy in one location. The hospital has already integrated Deep Resolve AI image reconstruction technology from Siemens Healthineers, accelerating MRI scan times and improving image quality.

Facility redesign expertise from the International Design Solutions team at Siemens Healthineers will aid future expansion, enabling the hospital to adapt to changing population health needs. The team brings decades of experience and will work collaboratively with the SVPH Building Services Department to achieve greater operational efficiency and improve patient flow, while allowing for future growth.

Support will include analysis of the current situation through the development, visualisation and

63 simulation of potential solutions, ultimately aiding the delivery of a sustainable healing environment, boosting patient experience and staff satisfaction.

The partnership will also include a bespoke workforce development programme designed to support recruitment, retention and development of staff following the challenging years of the COVID-19 pandemic. Covering both vendor-specific and vendorneutral learnings, the programme includes a range of training, education and hands-on learning experiences and is set to bolster the workforce and improve the patient journey. SVPH will also introduce a continuous service improvement programme focused on developing staff and optimising clinical workflows. The programme will ensure the hospital uses its technology in the most effective way while continuing to maximise sustainable, long-term efficiencies.

Brian Fitzgerald, CEO, St Vincent’s Private Hospital said “This ¤40 million investment programme in cardiology and radiology is an investment in the future health and wellbeing of our Professor Ronan Killeen Consultant Radiologist at St. Vincent's Private Hospital, Andy Wilks - Head of Enterprise Services for Siemens Healthineers Great Britain and Ireland, Edel O’Keeffe Director of Finance at St. Vincent's Private Hospital, Ghada Trotabas - Managing Director of Siemens Healthineers Great Britain and Ireland, Brian Fitzgerald - Chief Executive Officer of St. Vincent's Private Hospital with Grania Heal – Country Head for Ireland at Siemens Healthineers, and Rob Ruttledge - Director of Building Services at St. Vincent's Private Hospital

patients. Partnering with Siemens Healthineers in a first of its kind partnership in Ireland reflects our pioneering approach and our leadership at the forefront of new developments that enable us to deliver exceptional patient care.

The potential for AI in healthcare is vast and we believe that this new investment programme will improve clinical outcomes for patients and sets new standards for the delivery of personalised treatment and care in Ireland”.

Professor Ronan Killeen, Consultant Radiologist at St. Vincent's Private Hospital said: "The provision of AI solutions from Siemens Healthineers, such as Deep Resolve AI technology, as part of the Value Partnership significantly impacts our ability to improve MRI access and experience for patients. Higher resolution MRI imaging improves our interpretation and enables us to deliver more timely, accurate patient care. For example, the time to acquire a Lumbar Spine MRI has been reduced by more than 50 per cent, which is quite amazing."

HEARTFEST 2024: THE CROÍ MOBILE HEALTH HUB IS COMING TO EYRE SQUARE, GALWAY Get ready, Galway! Croí, the heart and stroke charity, is thrilled to announce that the Croí Mobile Health Hub will be arriving at Eyre Square for the much-anticipated Heartfest—a three-day festival dedicated to cardiovascular health and wellness. This event, now in its third year, will take place on the plaza at the top of Eyre Square from Wednesday 25th – Friday 27th September and is set to be a vibrant celebration of heart health.

The event runs from 10am to 4pm on the Wednesday and Thursday and 10am to 1pm on the Friday.

Heartfest is a free, holistic event designed to empower individuals and communities to take control of their cardiovascular health. Visitors can expect an array of interesting activities and resources, all aimed at making heart health accessible, engaging, and meaningful. Free blood pressure and pulse checks will be available, with cholesterol and stethoscope checks offered to those who meet specific criteria.

The Croí Health Team will be on hand to answer questions and discuss heart health with the public at this special event.

The Croí Mobile Health Hub is a first-of-its-kind in Ireland—a custom-built, 13.6-metre-long, multi-purpose mobile health unit that stands as the largest mobile stroke and heart disease detection unit in the country. This innovative vehicle can be converted from a facility with six private assessment cubicles and two consultation rooms into an open-plan educational space capable of hosting up to forty visitors. Its primary mission is to bring stroke and heart disease prevention into communities across Ireland through mobile early detection and

risk assessment programmes. It is designed to serve as a mobile community education and training facility, visiting towns, villages, schools, universities, workplaces, and sports clubs.

The state-of-the-art Croí Mobile Health Hub is the latest addition to Croí’s expanding fleet of community vehicles. Funded by the Joe & Helen O'Toole Charitable Trust, this hub will serve as the festival's centrepiece, offering visitors a chance to learn from Croí’s multidisciplinary health team about the risk factors for heart disease and stroke, healthy eating, physical activity, and even CPR. Over the three days, visitors can speak with Croí’s experts about the comprehensive support services and programmes available at Croí Heart and Stroke Centre, as well as the vital community resources offered by Croí’s mobile health units. Whether you are looking to check your blood pressure, get a stethoscope check, learn about bystander CPR or set new health goals, Heartfest is the place to be!

HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER 2024

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