Medical Independent 16th September 2025

Future obesity care

A multifaceted approach is required to address overweight and obesity in Ireland. David Lynch

Partnerships in global health

Niamh Cahill speaks to the Director of the HSE Global Health Programme Prof David Weakliam

PAGE 12-13

DoH and HSE dissatisfied with NTPF's suspension of Beaumont funding

PAUL MULHOLLAND

e Department of Health (DoH) and the HSE raised serious concerns about the National Treatment Purchase Fund’s (NTPF) recent decision to suspend funding to Beaumont Hospital, Dublin, believing that the move was taken without due process, the Medical Independent (MI) has learned. Internal documents obtained by MI under Freedom of Information law show both the HSE and DoH were surprised by the step, which followed an allegation that NTPF funding for insourcing had been utilised in Beaumont Hospital during core public hours.

e HSE was only informed of the suspension by the DoH

during a phone call on 11 April, after the NTPF noti ed Department o cials. Neither the NTPF nor Beaumont had directly informed the HSE of the allegation or the funding withdrawal, according to the documents.

In brie ng notes for the HSE audit and risk committee in June, HSE Chief Financial Ofcer Mr Stephen Mulvany stated that “it appears [the] NTPF have pulled all funding not just in relation to the specialty where there was an allegation without any investigation or due process. is is concerning to DoH, HSE, and Beaumont.”

e HSE CEO Mr Bernard Gloster, in an email to the Executive’s board on 12 June,

stressed that when the HSE learned about the issue “we had no evidence or information gathered and we simply had a verbal allegation that we were the last to be informed of”.

He con rmed the HSE’s internal audit (IA) team had since commenced a review and that “any proven wrongdoing will be referred to gardaí”.

His comments came the day after the NTPF issued a public statement on the issue. In the statement, the Fund con rmed that insourcing had been reinstated at Children’s Health Ireland (CHI) after CHI provided assurances it was complying with NTPF protocols.

e NTPF also disclosed that insourcing at “another public

Horror in Gaza demands a respons e It’s vital to act in the face of the atrocities we are witnessing, writes Dr Neasa Conneally

PAGE 17

hospital” had been suspended over “potential nancial irregularities”. It said both the DoH and the HSE had been noti ed of the decision.

Beaumont was not named in the NTPF’s statement, but was subsequently identi ed through media reports. Mr Gloster questioned why the NTPF had publicly highlighted Beaumont’s case at all while the audit remained ongoing.

“ e decision by [the] NTPF was to issue a statement which con rmed they, having received assurances, were restoring funding to CHI insourcing,” according to Mr Gloster’s email.

“ ere is no rationale or understanding as to why they now needed to issue additional [de-

The 16th International Conference on Medical Regulation, organised by the International Association of Medical Regulatory Authorities (IAMRA) and hosted by the Medical Council, took place on 3-6 September in Dublin. The conference, which was themed ‘People-focused regulation for a safer global community’, welcomed over 450 delegates from around the world.

(L-to-R) at the welcoming ceremony are

tail] relevant to ‘another public hospital’, ie, Beaumont… the di erence between CHI and Beaumont is that the former had a report… to rely on and the latter doesn’t until IA complete their investigation.”

He added that he had encouraged Beaumont to formally request the restoration of NTPF funding, in line with the assurances that had led to the resumption of funding at CHI.

Mr Gloster also said he was “most surprised” by aspects of the NTPF’s statement and noted he had “no recollection of [the] NTPF having ever contacted me in writing or by phone about any

Pictured

Dr Suzanne Crowe, President, Medical Council; Ms Joan Simeon, Chair, lAMRA; Lord Mayor of Dublin Cllr Ray McAdam; and Dr Maria O’Kane, Chief Executive Officer, Medical Council. See conference coverage on p8

reports

Photo credit: ©Fran Veale/ Julien Behal Photography

The journey to triple protection in type 2 diabetes mellitus1†

INVOKANA® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

> as monotherapy when metformin is considered inappropriate due to intolerance or contraindications

> in addition to other medicinal products for the treatment of diabetes

For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1 of the Summary of Product Characteristics (SmPC).1

† Improvement in glycaemic control and reduction of cardiovascular and renal morbidity and mortality are integral parts of the treatment of type 2 diabetes.1

1. INVOKANA® Summary of Product Characteristics September 2024.

Date of preparation: November 2024 IR-INV-16-2024

Invokana (canagliflozin) 100mg & 300mg film-coated tablets

Abbreviated Prescribing Information: Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Canagliflozin 100mg and canagliflozin 300mg, film-coated tablets. Use: Adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: (1) as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or (2) in addition to other medicinal products for the treatment of diabetes. Dosage and administration: Oral administration. Recommended starting dose is 100mg once daily, preferably taken before the first meal of the day. Tablets should be swallowed whole. In patients needing tighter glycaemic control and tolerating canagliflozin 100mg once daily, dose can be increased to 300mg once daily if eGFR ≥ 60 mL/min/1.73 m2 [Refer to SmPC for dose adjustment according to eGFR]. Care when increasing dose in patients ≥ 75 years of age, patients with known cardiovascular disease (CVD), other patients for whom the initial canagliflozin-induced diuresis poses risk. Correcting volume depletion prior to initiation of canagliflozin is recommended. Consideration of a lower dose(s) of insulin/insulin secretagogue if using canagliflozin as an add-on therapy is recommended. Elderly: Renal function and risk of volume depletion should be taken into account. Paediatric population: The safety and efficacy of canagliflozin in children under 18 years of age have not yet been established. Contraindications: Hypersensitivity to the active substance or any of the excipients. Warnings and

Precautions: [Refer to SmPC for more detail] Renal impairment: Limit dose to 100mg once daily in patients with eGFR < 60 mL/min/1.73 m2. Regardless of pre-treatment eGFR, patients on canagliflozin may experience an initial fall in eGFR that attenuates over time. Monitor renal function prior to and after initiating canagliflozin. Also monitor after initiating concomitant products that may reduce renal function. Patients at risk of volume depletion: Canagliflozin induces osmotic diuresis which may reduce intravascular volume and decrease blood pressure (BP). Caution should be exercised in patients for whom a canagliflozin-induced drop in BP could pose a risk. Advise patients to report symptoms of volume depletion. Canagliflozin is not recommended for use in patients receiving loop diuretics or who are volume depleted. Diabetic ketoacidosis (DKA) Rare cases of DKA, including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors. Presentation of DKA may be atypical. Risk of DKA appears to be higher in patients with moderately to severely decreased renal function who require insulin. Assess patients immediately if symptoms occur, regardless of blood glucose level. Where DKA is suspected/diagnosed, discontinue canagliflozin immediately. Treatment should be interrupted in patients who are hospitalised for acute serious medical illnesses and withheld for an appropriate period of days prior to major surgical procedures or acute serious medical illnesses associated with prolonged fasting. Monitoring of serum ketones is recommended in these patients. Consider alternative antihyperglycaemic therapy, including insulin.. Before initiating canagliflozin, consider factors in patient history that may predispose to DKA. DKA may be prolonged after discontinuation. Canagliflozin should not be used for treatment of patients with type 1 diabetes. Lower limb amputations: Before initiating canagliflozin, consider factors in patient history that may increase risk for amputation. Consider careful monitoring of patients with a higher risk for amputation, and counsel patients. Consider stopping canagliflozin in patients who develop events which may precede amputation. Necrotising fasciitis of the perineum: (Fournier’s gangrene): This rare but serious and potentially life-threatening event requires urgent surgical intervention and antibiotic treatment. Advise patients to seek medical attention if they experience a combination of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Urogenital infection or perineal abscess may precede necrotising fasciitis. If Fournier’s gangrene is suspected, discontinue canagliflozin and institute prompt

* If further glycaemic control is needed, the addition of other anti-hyperglycaemic agents should be considered.

§ Continue dosing until dialysis or renal transplantation.

treatment. Elevated haematocrit: Monitor haematocrit levels in patients with an already elevated haematocrit. Elderly: Elderly patients may be at a greater risk for volume depletion, are more likely to be treated with diuretics, and to have impaired renal function. Genital mycotic infections: Vulvovaginal candidiasis, and balanitis/balanoposthitis were reported in clinical studies. Urinary tract infections (UTIs): Complicated UTIs including pyelonephritis and urosepsis have been reported. Temporary interruption of canagliflozin should be considered. Cardiac failure: Experience in New York Heart Association (NYHA) class III is limited, with no experience in clinical studies with canagliflozin in NYHA class IV. Urine laboratory assessments: Patients taking canagliflozin will test positive for glucose in their urine. Lactose intolerance: Patients with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this product. Interactions: Diuretics: may increase risk of dehydration and hypotension. Insulin and insulin secretagogues: risk of hypoglycaemia; consider lower dose of insulin or insulin secretagogue. Effects of other medicines on Invokana: Enzyme inducers (e.g. St. John’s wort, rifampicin, barbiturates, phenytoin, carbamazepine, ritonavir, efavirenz) may decrease exposure of canagliflozin; monitor glycaemic control. Consider dose increase to 300 mg if administered with UGT enzyme inducer. Cholestyramine may reduce canagliflozin exposure; take canagliflozin at least 1 hour before or 4-6 hours after a bile acid sequestrant. Effects of Invokana on other medicines: Monitor patients on digoxin lithium, other cardiac glycosides, dabigatran Inhibition of Breast Cancer Resistance Protein cannot be excluded; possible increased exposure of drugs transported by BCRP (e.g. rosuvastatin and some anticancer agents). Pregnancy and lactation: Do not use canagliflozin during pregnancy or when breast-feeding. Discontinue canagliflozin when pregnancy is detected. Effect on fertility unknown. Effects on ability to drive and use machines: Canagliflozin has no or negligible influence on ability to drive and use machines. However, patients should be alerted to the risk of hypoglycaemia when canagliflozin is used as add-on therapy with insulin/insulin secretagogue, and to the elevated risk of adverse reactions related to volume depletion. Side Effects (SEs): Adverse reactions are based on the pooled analysis of placebo-controlled, clinical studies. Very Common (≥ 1/10): vulvovaginal candidiasis, hypoglycaemia in combination with insulin or sulphonylurea. Common (≥ 1/100, <1/10): balanitis or balanoposthitis, urinary tract infection (pyelonephritis and urosepsis have been reported post-marketing), constipation, thirst, nausea, polyuria or pollakiuria, dyslipidaemia, haematocrit increased. Uncommon (≥ 1/1,000 to < 1/100): dehydration, dizziness postural, syncope, hypotension, orthostatic hypotension, photosensitivity, rash, urticaria, bone fracture, renal failure (mainly in the context of volume depletion), blood creatinine increased, blood urea increased, blood potassium increased, blood phosphate increased, lower limb amputations (mainly of the toe and midfoot) especially in patients at high risk for heart disease. For less frequent side effects see SmPC. Pack sizes: 30 x 1 film-coated tablets. Legal category: POM.

Marketing Authorisation number: EU/1/13/884/001-004 (100mg) and EU/1/13/884/005-008 (300mg).

Marketing Authorisation holder: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.

Date of preparation: September 2024.

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 A. Menarini Pharmaceuticals Ireland Ltd. Phone no: 01 284 6744

Ex-Medical Council CEO conducting review into PA role

CATHERINE REILLY

Former Medical Council CEO Mr Leo Kearns is conducting an independent review into the role of physician associates/assistants (PAs) on behalf of the HSE.

A HSE spokesperson told the Medical Independent it had appointed Mr Kearns to lead the independent review. He is supported by a project/research team and a clinical advisory group.

“Mr Kearns has extensive expertise in governance within healthcare and a deep background in specialist medical education and training, professional competence, clinical leadership, and quality improvement,” said the spokesperson.

The review, which is due to conclude this year, will make recommendations regarding governance, scope of practice, and appropriate and safe deployment of the PA

Staffing challenges at Coombe

The Coombe Women and Infants University Hospital in Dublin has sought an “uplift” to a “HSE imposed” staff ceiling.

The issue was discussed at a meeting of the Coombe’s board of guardians and directors in May, according to minutes obtained by the Medical Independent (MI) under Freedom of Information law.

Board members discussed human resource matters and the “HSE imposed staffing ceiling”. Members were told that an “uplift” in the ceiling had been sought.

The process for filling maternity leave posts must go through the Regional Executive Officer of HSE Dublin and Midlands, the meeting heard. However, approvals will only be forthcoming if the hospital is operating within its whole-time equivalent (WTE) ceiling and can manage the cost within its financial limit. This was “extremely challenging given we have not had an uplift to our WTE ceiling following the meeting with the HSE in February”, according to the minutes.

A Coombe spokesperson told MI that the uplift to the WTE ceiling had not yet occurred, but the hospital continued to engage with the HSE.

“While it continues to be a challenge, importantly, it has not affected patient care or safety.”

Separately, the board meeting in March considered proposals to invite a GP who provides services in the local area to join the board. This was because the previous GP who retired from the board was not replaced.

The spokesperson said the position had not yet been filled as the hospital was still seeking a suitable candidate.

role. In the meantime, the recruitment of PAs within the HSE is “paused”.

Mr Kearns departed his role as CEO of the Medical Council in September 2024. He is also a former CEO of the RCPI. In December 2024, the Medical Council stated that it would not be the appropriate regulatory body for PAs. Its statement referred to “the potential for emerging patient safety risks arising from confusion for patients, as observed recently because of regulation of PAs by the GMC [General Medical Council] in the UK”.

“The Medical Council is aware that PAs are being trained and employed in the Irish healthcare system, working under the supervision of doctors to support the provision of healthcare, contribute to patient management, and improve healthcare access. [The Council] considers it essential that these PA roles are defined with respect to their scope of practice.”

The RCSI operates the only PA postgraduate programme in this jurisdiction. The College has advocated for regulation of the PA role.

 Continued from p1

matters associated with wait list initiatives concerns”.

In its statement on 11 June, the NTPF had said it would “urgently” work with the Department and HSE on the issue and had written to all public hospitals to seek assurances of compliance with its rules.

A spokesperson for the HSE told MI the audit remains “ongoing” and is “expected to be completed shortly”.

The HSE has committed to ending insourcing in public hospitals by next year.

Crohn’s disease: Diagnosis and management

DAVID LYNCH

DAVID LYNCH david@mindo.ie

Informing the future direction of obesity care

The next national obesity plan will be published against a background of major clinical and diagnostic developments. David Lynch reports

Last month, the Minister for Public Health, Wellbeing and the National Drugs Strategy, Jennifer Murnane O’Connor, launched a public consultation process to inform the development of Ireland’s next national obesity strategy.

“Obesity is one of the most pressing public health challenges facing Ireland today, with over half of our adult population affected by overweight or obesity,” said Minister Murnane O’Connor.

“This is not just a personal health issue. It’s a national concern that impacts our healthcare system, our communities, and our future.”

According to the Department of Health, the upcoming strategy will replace the current policy – A Healthy Weight for Ireland: Obesity Policy and Action Plan 2016–2025 (OPAP) – and address “new and emerging” challenges.

Some 60 per cent of adults and one in five children in Ireland are living with overweight or obesity.

According to the Minister, Ireland has made “important progress in stabilising obesity rates and implementing key actions” as a result of the current strategy.

However, she added, “now we must go further.”

When outlining the “achievements” of the OPAP, the Department highlighted initiatives such as the publication of healthy eating guidelines tailored for young children and older adults, the introduction of the sugar-sweetened drinks tax in 2018, and the development of the HSE’s model of care for the management of overweight and obesity.

Yet despite these measures, the HSE acknowledges that Ireland continues to record some of the highest obesity rates in Europe. The condition places a significant burden on the health system and is closely linked to chronic illnesses including type 2 diabetes, cardiovascular and respiratory disease, several cancers, persistent pain, and musculoskeletal disorders.

Credit: iStock.com/calvindexter

Bariatric surgery

In recent years, advances in obesity care have included both pharmaceutical options (see panel p5) and surgical interventions.

As part of its model of care, the HSE has incorporated bariatric surgery as a key component in the management of severe and complex obesity.

The Medical Independent (MI) has previously reported that the number of surgeries in public hospitals in Ireland has increased in recent years. However, most experts say the level remains too low.

In new figures provided to MI, the HSE said that 175 bariatric surgeries were delivered by model 4 hospitals nationally in 2024.

Of this total, 118 surgeries took place in St Vincent’s University Hospital (SVUH), Dublin, while a further 57 surgeries were delivered by Galway University Hospitals (GUH).

This year, 128 bariatric surgeries were delivered by model 4 hospitals nationally up until the end of July – 77 surgeries in SVUH, and 51 in GUH.

An Executive spokesperson said the HSE National Clinical Programme for Obesity continues to advocate for funding to fully implement the obesity model of care. A full implementation of the model would result in three bariatric surgery services nationally at model 4 sites. Each would deliver a minimum

of 200 surgeries per annum.

The HSE is working towards achieving this target over the next three years, added the spokesperson.

General practice

General practice is regarded as crucial in meeting the national challenges of obesity. Whether or not obesity should be included in the chronic disease management (CDM) programme in general practice is a matter of ongoing debate and discussion (see top panel p6).

According to the HSE, there “are multiple drivers” that influence obesity including genetic, environmental, and socio-economic factors.

The final factor is one keenly felt by members of Deep End Ireland, an organisation of GPs working in some of the most disadvantaged communities in the country.

Dr Edel McGinnity, GP in Mulhuddart, Dublin, told MI that obesity is “very much a disease of poverty”, adding that the cheapest food available in shops is often the most obesogenic.

“There is a lack of headspace for people to do exercise and general selfcare because many of our patients are so busy getting through the day,” Dr McGinnity explained.

For some patients, joint replacement surgery is needed, but this option is often denied when orthopaedic teams refuse to operate on those above a certain

body mass index.

As a result, she added, some patients are left relying on “vast amounts of painkillers” when they cannot access the surgery they need.

Dr Catherine Clifford, GP in Fermoy, Co Cork, said addressing obesity requires “societal change”, which enables a healthy diet and exercise for the entire population.

“Sports club membership can be prohibitively expensive and it is difficult to adjust fees according to financial status from a club administration perspective,” Dr Clifford told MI

“A nationwide scheme where a medical card improves access to sport through entitling someone to reduced fees would be helpful.”

Dr Vivienne Wallace, GP in Coolock, Dublin, pointed to the example of the City of Edinburgh Council in Scotland, which gives reduced rate access to families of children under one year of age to soft play centres and gyms.

“It’s a great idea to get people started on a healthy track. And it’s also for everyone which I think makes it very inclusive.”

Black market

Earlier this year, the Health Products Regulatory Authority (HPRA) reported an upward trend in detentions of illegally traded GLP-1 products. Over 10,000 unauthorised GLP-1 ‘patches’ were among items detained in ongoing enforcement action by the HPRA between January and June this year.

“There has been a notable increase in the prevalence of unauthorised GLP1 products claiming to contain semaglutide, liraglutide, or tirzepatide,” Ms Gráinne Power, Director of Compliance at the HPRA, said earlier this month. These include unauthorised tablets, pens and vials as well as transdermal patches. This trend in the market for unauthorised weight loss drugs is evident at prac-

Minister Jennifer Murnane O’Connor

Prof Susan Smith

tices on the ground.

Dr Niamh O’Brien, GP in Galway, told MI that black market GLP-1 sales are “ very common”.

She added that obesity is a “growing and hugely prevalent issue”, which “needs to be” included under the CDM programme.

Dr O’Brien described the “dreadful dichotomy” that she has in her practice population between the “small minority” who can a ord GLP-1 agonists and the majority who cannot.

Dr Anna Beug, GP in the Coombe, Dublin, also highlighted the “huge issue” of black market GLP-1, with people “spending money that they don’t have” on such medication.

“Regarding funding for GLP-1 agonists, I think the criteria certainly need to be reviewed,” she said.

“But I think given the massive potential cost to the State, a balance needs to be struck between investing in prevention and treatment.”

Dr Beug added that childhood obesity is a major problem and the area where most resources should go. She also emphasised that obesity is an issue strongly linked to poverty.

Stigma

Prof Susan Smith, GP and Professor of General Practice, Trinity College Dublin, told MI that obesity continues to be framed in terms of “blame and personal responsibility” rather than through the lens of wider structural determinants.

e next strategy requires a “stronger focus on healthcare professional education” in obesity care and weight bias, according to Dr Gráinne O’Donoghue (PhD), Associate Professor at the School of Public Health, Physiotherapy and Sports Science, University College Dublin (UCD).

Dr O’Donoghue told MI that people liv-

ing with obesity often encounter stigma and discrimination within the health system. is can reduce their quality of care, damage trust in professionals and discourage them from engaging with health services.

“At present, many Irish health professionals report feeling unprepared to raise weight issues with patients,” Dr O’Donoghue explained. “ ey are often unsure about the most appropriate language to use, lack con dence in their knowledge of treatment pathways, and worry that raising the topic could harm the patient relationship or negatively a ect mental health. is results in missed opportunities for early support and intervention.”

To address this, the next national plan should commit to embedding obesity education into medical, nursing, and allied health curricula, ensuring that new graduates are trained to recognise obesity as a complex, chronic condition rather than an individual failing.

For the existing workforce, regular continuing professional development

should focus on evidence-based care, practical communication skills, and strategies to reduce weight bias, according to Dr O’Donoghue.

Training should also highlight the psychological impact of stigma and equip professionals to discuss weight in a supportive, person-centred, way.

“By prioritising professional education and tackling weight stigma, Ireland can build a healthcare workforce that is condent, compassionate, and better able to support patients living with obesity. is would not only improve individual outcomes, but also strengthen trust in the health system as a whole.”

Education

Dr O’Donoghue highlighted work her UCD team recently completed on the Awareness, Care and Treatment in Obesity maNagement (ACTION) Ireland Study.

e manuscript is currently under review. However, Dr O’Donoghue noted that the data underlines the importance of healthcare professional (HCP) education around obesity care and how tackling weight stigma should be a core component of the upcoming strategy.

e study noted that barriers to e ective care include internalised stigma and self-blame, which can lead to delays in help-seeking. Misconceptions about obesity as a simple lifestyle issue can reduce engagement with professional care.

e study found that despite the recognition that obesity is a chronic disease, clinical management remains largely limited to lifestyle advice.

It also reported that multidisciplinary, pharmacological, and surgical options are underutilised.

The future of weight loss medication

In January, the Medical Independent (MI) reported that expertise in new weight loss medication would be required during the formation of the next national obesity policy.

Minutes from meetings of the obesity policy implementation oversight group in 2024 noted the need for input from the HSE “pharmacology unit” regarding the next plan.

This was “due to the rise of Ozempic [semaglutide] and other obesity drugs in recent years”.

A Department of Health spokesperson told MI that “the next OPAP [obesity policy and action plan] will reflect the many changes that have taken place since 2016 in relation to health promotion, disease prevention, and the management and treatment of obesity.”

Speaking at the IMO AGM in April, Prof Michael Barry, Clinical Director of the National Centre for

Pharmacoeconomics and member of the HSE drugs group, warned that Ireland could experience a significant rise in medicines expenditure if a decision was taken to fund weight loss drugs for all those who could likely benefit.

In such a scenario, he said a figure of €10 billion per year was possible.

Prof Barry estimated that the State’s current annual drugs bill is approximately €4 billion. A number of weight loss drugs are currently being assessed regarding their suitability for State schemes.

The HSE drugs group makes recommendations on the pricing and reimbursement of medicines.

A HSE spokesperson told MI it is committed to providing access to as many medicines as possible, in as “timely a fashion as possible, from the resources provided to it”.

The Executive “robustly assesses applications for pricing and

reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients”.

The HSE said its decisions on which medicines are reimbursed by the taxpayer are made on objective, scientifi c, and economic grounds.

“There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed,” according to the spokesperson.

Prior to making any decision on pricing and reimbursement, the HSE considers criteria including: The health needs of the public; the cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services; and the availability and suitability of items for supply or reimbursement.

MINDO NUMBERS

40 years since Ireland’s first heart transplant at the Mater Misericordiae University Hospital in Dublin. The anniversary was marked on 10 September.

382,395 dosage units of falsified and other illegal medicines were detained between January and June 2025 by the Health Products Regulatory Authority.

30% of these were sedatives, 16 per cent were anabolic steroids, and 16 per cent were erectile dysfunction medicines.

17,239 patients were treated in hospitals and 4,395 patients were treated in hospices by specialist palliative care teams in 2024, according to the HSE. Palliative Care Week ran from 7–13 September.

15,253 patients were treated in their own place of residence in 2024.

6 population-based screening programmes are currently in place. The national screening advisory committee’s annual call for submissions came to an end earlier this month.

Dr Gráinne O’Donoghue

Continued on p6 

NIAMH CAHILL

GPs want CDM programme for obesity, but Department noncommittal

The chronic disease management (CDM) programme in general practice should include overweight and obesity to help prevent the development of other diseases, according to GPs.

However, as reported in the previous issue of the Medical Independent (MI), it is understood the Department of Health currently favours the introduction of other, more narrowly focused, models of care.

According to IMO GP committee member Dr Austin Byrne, the introduction of a programme tackling obesity, which is a risk factor in the development of a number of other diseases, is needed to improve overall population health.

The Waterford-based GP told MI that instead of focusing “on the tail ends of diseases and conditions, we need to move it right back to prevention”.

Dr Byrne called for a programme that would focus on all aspects of care around overweight and obesity, including the use of weight loss medication.

“We don’t have a comprehensive guideline set for GLP-1 agonists,” Dr Byrne said.

“It is something that would very much fit into a standalone programme of care, largely delivered by GPs, with allied healthcare professionals’ input.”

However, he said such a programme would not just be around the prescription of GLP-1 agonists.

“We need a weight loss programme and within that programme some people may use GLP-1s. But we are already seeing early trial evidence about the use of selective beta

One of the study’s recommendations focuses on HCP training to enhance skills in behavioural, pharmacological, and surgical interventions.

It also calls for the promotion of stigma-free, empathetic dialogue using motivational interviewing, and weightneutral language.

▶ e consultation on the next obesity national strategy is open until 18 September. See www.gov.ie/en/ department-of-health/consultations/ public-consultation-on-a-new-national-obesity-strategy-in-ireland/

▶ See Dr Faisal I Almohaileb’s and Prof Carel Le Roux’s clinical feature on obesity medication, p23.

agonists and that will be a thing that will feed in next year and the year after – newer and better drugs and safer drugs. This is changing all the time. We need to have programmes funded based on best management of disease entities as opposed to specific drugs.”

As recently reported in MI , talks have commenced between Department officials and IMO representatives on the introduction of a chronic kidney disease management programme.

But, according to Dr Byrne, “narrow models of care” like this are more limited in what they can achieve in comparison to a potential programme for obesity.

GPs are not resourced for the management of obesity and formal supports within the State are inadequate, according to Chief Executive of the IMO Ms Susan Clyne.

This is why the Organisation has called for a structured standalone overweight and obesity management programme in general practice.

“The IMO advocates for a programme of ‘patient first’ care that will prescribe medication for a defined group, based on need, rather than a ‘drug first’ pathway,” Ms Clyne told MI

“This will become an increasing issue in the near future, with the growing number of available agents soon to arrive to market, each with their own suitability for different patient cohorts and monitoring requirements.

“The presence of obesity in early adult years increases the lifetime risk of premature death by around 80 per cent in both men and women via a multitude of direct and indirect disease effects and reduction in this risk is achieved with reduction

in weight. Significant benefit arises from even modest reductions and longitudinal continuity of care, the cornerstone of general practice, can ensure a supportive and responsive environment is created from early on and maintained for the longer term.”

Ms Clyne added that due to the relatively recent and widespread availability of a range of highly effective medications for treating obesity, “we are witnessing a dangerous and growing problem of patients accessing medication both online and backstreet without adequate medical assessment or ongoing medical supervision.”

“It is not just a question of writing a prescription or managing to obtain access to a drug treatment,” she said.

“We know that in unsupervised use, 80 per cent of medication users will have abandoned treatment by 18 months with resulting gain of prior weight and return of health risk. This represents an unfortunate missed opportunity in an initially motivated cohort and GPs are increasingly encountering patients with medication side-effects who seek assistance in managing these side-effects and maintaining their disease management efforts.”

Since its introduction in 2020, the CDM programme has engaged more than 400,000 medical card and GP visit card patients.

Patient with diseases such as asthma, chronic obstructive pulmonary disease, heart disease, and type 2 diabetes and, more recently, women who have experienced gestational diabetes and pre-eclampsia, are treated through the programme.

The statistics underpinning a public health crisis

According to the Healthy Ireland Survey 2024:

▶ Just over three in five men (63 per cent) reported overweight or obese weight measurements, while half (50 per cent) of all women reported the same. These figures are the same as those reported in 2022.

▶ Just over one-quarter (27 per cent) of people said they eat one snack food each day, an increase of three points since 2019 (24 per cent). A further 35 per cent reported they eat two or more

snacks each day.

▶ Just under one-third (32 per cent) of the population reported consuming sugar-sweetened drinks at least once per week. This includes 9 per cent who reported consuming these every day (29 per cent and 8 per cent respectively in 2019).

▶ Fruit was eaten daily by 62 per cent of the population and 73 per cent reported eating vegetables every day. Reports of daily fruit and vegetable consumption declined since 2019 (65 per cent and 75 per

cent respectively). Five or more portions of fruit and vegetables are eaten each day by 28 per cent of the population, six points lower than reported in 2019 (34 per cent).

The survey is conducted annually with a representative sample of the population aged 15 and older living in Ireland.

The summary report is available at: https://assets.gov.ie/static/ documents/healthy-irelandsurvey-summary-report-2024.pdf

Dr Austin Byrne

 Continued from p5

Dublin

GP Study Day

In-person symposium for GPs & Practice Nurses

In-person event only, CPD applied for Saturday, 27th September

Medicine for the Elderly Speakers

Orthopaedics,

REGISTRATION

8:15am – 1:45pm | Crowne Plaza Hotel, Blanchardstown, Dublin 15

8:15am - 8:30am

· Introduction & Welcome – Mr. John Hurley, CEO, Mater Private Network

Session 1 Women’s Health 8:30am - 9:40am

· All About the Vulva! Stopping the Taboo – Ms. Claire Thompson, Consultant Gynaecological Oncologist

· Managing Female Incontinence in Primary Care – Dr. Bobby O’Leary, Consultant Urogynaecologist

· Genetics, HRT & Breast Cancer – Mr. Karl Sweeney, Consultant Breast Surgeon

Session 2 Medicine for the Elderly 9:45am – 10:55am

· Common Presentation of Retinal Diseases – Mr. Shane Whitlow, Consultant Ophthalmologist

· Update on Giant Cell Arteritis – Prof. Andrea Lorente, Consultant Neurologist

· New Horizons in Alzheimer’s Disease – Updates on Diagnosis & Therapy –Dr. Shane O’Hanlon, Consultant Geriatrician

Session 3 Orthopaedics, Spine & Rheumatology 11:20am – 12:30pm

· Hip & Knee Surgery – Pre & Post-operative FAQS – Prof. Kevin Mulhall, Consultant Orthopaedic Surgeon

· Cervical Myelopathy – Clinical and Radiological Aspects – Mr. Paolo Rizzo, Consultant Spinal Neurosurgeon

· Managing the Spondyloarthritis Spectrum – Dr. Len Harty, Consultant Rheumatologist

Session 4 Oncology

12:35pm – 1:45pm

· Role of Stereotactic Radiation in Prostate Cancer – Prof. Daniel Cagney, Clinical Director of Radiation Oncology

· Recent Advances in Urological Surgery – Mr. Ronan Long, Consultant Urologist

· Current Perspectives on Myeloma and Lymphoma – Prof. Andrea Piccin, Consultant Haematologist

This event is free of charge, but pre-registration is essential. Scan QR code or visit the Events page on:

www.materprivate.ie

Ms. Claire Thompson

Mr. Shane Whitlow

Prof. Kevin Mulhall

Prof. Daniel Cagney

Women’s Health Speakers

Dr. Bobby O’Leary

Prof. Andrea Lorente

Mr. Paolo Rizzo

Mr. Ronan Long

Mr. Karl Sweeney

Dr. Shane O’Hanlon

Dr. Len Harty

Prof. Andrea Piccin

Spine & Rheumatology Speakers

Oncology Speakers

International Conference on Medical Regulation, Clayton Hotel, Burlington Road, Dublin, 3-6 September 2025

Open disclosure ‘still not the norm’ in Irish healthcare – Varadkar

The practice of open disclosure is still not “the norm” in Irish healthcare, former Taoiseach Leo Varadkar has stated.

Mr Varadkar, a trained GP and former Minister for Health, was speaking at the International Conference on Medical Regulation in Dublin on 4 September. e event was organised by the International Association of Medical Regulatory Authorities and hosted by the Irish Medical Council.

“I went to college in the 1990s – I studied medicine between 1997 and 2003 –so it is a long time ago, and we were told about the duty of candour, about open disclosure, about how when doctors are sued or when complaints are made against them, it is more often about how they dealt with it afterwards than the mistake they actually made,” Mr Varadkar told the conference.

“I don’t think that penny has dropped, quite frankly, across the professions. We have introduced legislation [in 2024] requiring open disclosure in certain cases where a serious mistake has been made, but I am not convinced we are in a much better place than we were 10 or 20 years ago. I would be interested to know if that is the international experience, but it is something that worries me,” added Mr Varadkar, who is working in consultancy and academia since stepping down as Taoiseach in April 2024.

Mr Varadkar also suggested healthcare regulators should engage in some degree of “surveillance” to proactively identify

serious failures in practice.

“I know some regulators can only act on complaints, others are able to do a bit of surveillance, but I think if you can, you should. And I don’t think you should necessarily wait for legislation to do it; you can do things without a legislative framework.

“We had a situation that we are dealing with now here in Ireland where it became

apparent that a very large number of children were having hip surgeries they didn’t need and it is a very serious issue and quite a scandal in my view….” Mr Varadkar said there should be “adequate surveillance to throw up those red flags”. He said society should not have to rely on whistleblowers or a series of complaints from patients to iden-

tify issues of serious concern.

Mr Varadkar also made strong comments in relation to private healthcare. Based on anecdotal information, he expressed concern about the extent to which “unnecessary” investigations and procedures, driven largely by pro t, were taking place in private healthcare.

“I think we need to open our eyes to the fact that happens in our society. And an unnecessary operation is an assault and we need to treat it as exactly that.”

Separately, Mr Varadkar pointed to a “real challenge” in the system of undergraduate medical education. He noted that a “huge number” of overseas students are trained in Irish medical schools and most return to their home countries.

“We also export a huge number of Irishtrained doctors and therefore have a disproportionate number of people working in our health service who come from abroad. And that is great, but not really ideal when we train so many doctors and at the same time have to invite so many doctors in from other parts of the world.”

Mr Varadkar also spoke about gender bias in healthcare and in the medical profession internationally.

He noted that heart attack symptoms can present di erently in women, but this is often not recognised in healthcare settings. He also referred to underdiagnosis of conditions such as endometriosis and migraine in women.

Mr Varadkar added there was a “significant gender gap” in the medical profession in regard to the most senior roles.

Importance of ‘learning culture’highlighted by advocate

The importance of a learning culture in healthcare was emphasised at the International Conference on Medical Regulation in Dublin.

In an address on 4 September, Mr Tiberius Pereira of Patients for Patient Safety Ireland spoke of the need to gain an understanding of the environment and culture that contributed to adverse events. is was in addition to the requirement for full open disclosure to patients and a level of accountability for what went wrong.

Mr Pereira said it was important to acknowledge the “really high standard of care” in Ireland, which was provided by healthcare professionals “who truly care”.

“For most people, they appreciate the health services they receive, and most people recognise our healthcare is inherently risky, and every now and then something does go wrong.” However,

Mr Tiberius Pereira

people must receive “full and honest and timely” explanations in these situations. is type of response engenders a greater trust in the system. “On the other hand, if that doesn’t happen, people do start to lose trust.”

Patients for Patient Safety Ireland was formed over 12 years ago under a World Health Organisation programme. Members work in partnership and collaboration with healthcare professionals and policymakers to make health services safer and enable the patient voice to be heard fully.

Mr Pereira said most members had experienced serious harm either directly or through a ected family members.

“And most of us have had to go through a process [where it] hasn’t been easy to get answers to… very basic questions and very understandable questions.”

Mr Pereira also highlighted barriers to becoming involved in patient advocacy for those in disadvantaged situations. He said people living in poverty and homelessness often experienced the worst health outcomes, and their voices must be heard.

Speaking to the Medical Independent, Mr Pereira said translating policy into

practice remained a key challenge for the Irish health system.

“ ere are lots of good policies, strategies, and recommendations [for healthcare]; it is how does that make its way to the patient experience?”

In regard to implementation of open disclosure, for example, the level of progress to date was “disappointing”.

He suggested that an independent audit of open disclosure practice could help drive progress. In addition, he said greater use of face-to-face training may be bene cial.

Other speakers at the conference included Prof Dame Carrie MacEwen, Chair of the General Medical Council, UK, who discussed the importance of compassionate leadership in medical regulation; and Dr Austin O’Carroll, GP in inner city Dublin, who spoke on broadening access to medical education and training to people from disadvantaged groups.

Mr Leo Varadkar

Photo Credit: Julien Behal Photography

A.MENARINI PHARMACEUTICALS

IS HOSTING A NATIONAL GP STUDY DAY

SATURDAY 04 OCTOBER 2025

Galmont Hotel

Lough Atalia Road

Galway

09.00 – 13.15

For further information, and to book your place please scan the QR code, or contact your local Menarini representative, or go www.hcp-menarini.ie

CHAIRPERSON

Dr John Lally

GP, GP Trainer, ICGP CME GP Tutor, Galway City Medical Centre

Professor Rónán Collins

Consultant in Geriatric & Stroke Medicine

Tallaght University Hospital

Saving BrainsThe Challenge of Stroke

Professor Anthony O’Regan

Respiratory Consultant

University Hospital Galway

Simplifying COPD Management within the new GOLD Guidelines

Dr Patrick Divilly Consultant of Endocrinology & Diabetes Mellitus

St. Vincent’s University Hospital, Dublin

Type 2 Diabetes in era of Chronic Disease hubs

Dr Juan Trujillo

Paediatric Consultant

Cork University Hospital

Taming the Tissues with Personalised Pathways:

Comprehensive Management Strategies for Allergic Rhinitis

Nurse Selene Daly Tarpey

Nurse Tutor

CNME Sligo Leitrim West Cavan

The Skin-Mind link: A new approach for Holistic patient care in Dermatology

CPD RECOGNITION HAS BEEN SOUGHT FOR THIS MEETING.

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If you would like to hear more about our meetings, products and other valuable information please scan the QR code.

Please note promotional stands will be present at the meeting.

This meeting is being organised and run by A. Menarini

Pharmaceuticals and speakers are being contracted for the purposes of the meeting - A. Menarini has no input into the content of the speakers’ presentations other than reviewing for IPHA code compliance.

NTPF audit reveals delays in outpatient appointments

NIAMH CAHILL

Inefficient processes in the management of outpatient waiting lists meant one patient – whose care was defined as urgent – was left waiting over 400 days for an appointment date, found an audit by the National Treatment Purchase Fund (NTPF).

Published in March this year, the audit took place between May 2024 and November 2024. It was released to the Medical Independent through Freedom of Information law.

The audit and quality assurance report on outpatient data across a number of hospitals found that for 18 patients with a clinical prioritisation category (CPC) of urgent, appointment dates were not scheduled within 28 days of their referral date, as recommended by the NTPF.

The timeframe instead ranged from 42 to 147 days, with one patient waiting 427 days.

The CPC is the level of urgency a clinician assigns to a referral, which can be categorised as urgent, semi-urgent, and non-urgent.

An examination of semi-urgent referrals found that 11 patients were not given appointment dates within the 13-week recommended timeframe from the refer-

ral received date.

Instead, the timeframes ranged between 15 and 55 weeks. The findings were among a number of issues identified in the audit report, which was titled Scheduling of Outpatient Appointments and Management of the Did Not Attend Process in Line with the National Outpatient Waiting List Management Protocol 2022

Outpatient waiting list data relating to 269 patients from seven unnamed public hospitals were reviewed for the audit.

Two areas were examined: The scheduling of outpatient appointments and the management of patients who did not attend (DNA) their outpatient appointment.

The audit sought to examine whether national protocol was followed and identify issues impacting the accuracy of data submitted to the NTPF.

A patient’s start time on outpatient waiting lists should begin on the date the referral was received by the hospital.

Of the 269 referrals reviewed, 87 per cent were confirmed as having a referral received date recorded, the audit showed.

Correct referral entry dates onto hospital patient administration systems (PAS) are important as the date marks the beginning of a patient’s waiting time for care.

HSE group to bring ‘consistency’ to workforce planning across regions

DAVID LYNCH

A newly established HSE group has begun work on bringing greater “consistency” to workforce planning across the health regions.

The strategic workforce planning and resourcing governance group (SWP&RGG) held its first meeting on 28 April.

Its creation was noted at that month’s meeting of the Sláintecare programme board.

According to board minutes, the new group will lead efforts to modernise recruitment, strengthen staff engagement, and retention.

It is also intended to help foster a “positive and inclusive” workplace culture.

A HSE spokesperson told the Medical Independent that the SWP&RGG was established to help align the health regions and the evolving HSE organisational structure.

According to the spokesperson, the group aims to ensure “robust governance”, regional autonomy, and national consistency in workforce planning.

Membership includes senior leadership from across the HSE, including nominees from HSE human resources and the Office of the Chief Clinical Officer.

“While trade unions and representative bodies are not listed as core members of the SWP&RGG, they are explicitly mentioned as key interfaces and may be involved through guest advisory roles... or subgroups,” according to the spokesperson.

The SWP&RGG’s priorities for the second half of 2025 include overseeing the roll-out of agreed governance structures, reviewing 2024 actions, and aligning them with emerging priorities.

Tasks also include finalising and endorsing the updated HSE resourcing strategy, as well as tracking the progress of resourcing workplans.

“The group’s role is to coordinate, align, and streamline efforts across the system, not duplicate them. It aims to ensure a joined-up approach and avoid siloed work,” said the spokesperson.

The audit found that for 73 patients where the referral date did not match the date entered onto the PAS, the discrepancy in start wait time ranged from one to 13 working days.

In three cases, the delay was greater –44, 69, and 140 working days.

According to national protocol, patients should be given a minimum of two weeks’ notice of their appointment. The appointment date should also not be scheduled more than six weeks into the future.

However, in many cases, patients were given appointments outside this timeframe, with one scheduled 148 weeks later.

The examination of the management of DNAs revealed “low compliance levels”, particularly regarding patients assigned a CPC of non-urgent and semi-urgent across all hospitals.

The NTPF recommended that hospitals consider managing and processing referrals in a centralised administration office “to ensure standardisation of processes across all specialties”.

The audit revealed there were three referral management systems in use across the seven hospitals.

Referrals were managed either by a central referrals office, at specialty level, or by the individual consultant secretary.

“This overview report draws together cumulative key findings and trends from the comprehensive analysis of the audits conducted in seven hospitals across the HSE health regions and the Children’s Health Ireland Group,” the report stated.

“It provides information and insights to stakeholders on current outpatient scheduling and DNA management processes, highlighting areas for improvement and adherence to national protocols.

“Based on audit findings, clear opportunities for improvement and efficiencies were identified to a greater or lesser extent across all hospitals which were addressed in the individual hospital reports.

“Senior stakeholders within the health regions and HSE acute Access and Integration have received individual hospital reports; it is our expectation that they will oversee the level of progress achieved in relation to addressing audit recommendations.”

The report stated that the NTPF recognised the “significant challenges at hospital level”. The NTPF would “continue to provide guidance to hospitals” through training and education on the protocol to enhance administrative efficiencies in the delivery of timely and equitable access to outpatient services.

Risk of ‘duplication’ with new Traveller mental health group

DAVID LYNCH

A new specialist group focused on Traveller mental health is to be established under the national mental health policy, despite earlier concerns about possible overlap with existing committees.

The initiative was announced last month by Minister for Mental Health Mary Butler as part of Sharing the Vision – A Mental Health Policy for Everyone (2020–2030). The national implementation and monitoring committee (NIMC), which oversees the policy, is expected to formally establish the group in the autumn.

However, minutes from an NIMC steering committee meeting in May show that some members questioned the need for a new structure.

The discussion noted that the HSEchaired national Traveller and Roma mental health working group is already progressing several policy commitments in relation to Travellers.

Establishing another group with a similar remit, according to the minutes, carried “a risk of duplication”.

As a result, the committee concluded at the time that the proposal “did not meet the criteria for establishing a specialist group”.

Asked about these concerns, a spokesperson for the Department of Health told the Medical Independent that the Traveller mental health group is proceeding under

the NIMC structures and will operate with “defined terms of reference”.

“This will complement the work of the HSE national Traveller and Roma mental health working group, which is focused principally on delivering and monitoring actions across a range of Department of Health and HSE policies and strategies.”

It is envisaged that the specialist group will focus principally on mental health policy enhancement and alignment through “adopting a whole-of-government lens”.

“The specialist group and the HSE working group will collaborate and cooperate as appropriate, to ensure alignment and avoid duplication of effort.”

Minister Mary Butler

Ryaltris™ 25 mcg/actuation + 600 mcg/actuation nasal spray, suspension.

Prescribing information

Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.

Presentation: One delivered dose contains mometasone furoate monohydrate equivalent to 25 mcg mometasone furoate and olopatadine hydrochloride equivalent to 600 mcg olopatadine. White, homogeneous suspension.

Uses: In adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis.

Dosage: For nasal use only. Adults and adolescents (12 years of age and over) two actuations in each nostril twice daily (morning and evening). Elderly: no dose adjustment required. Children under 12 years: not recommended. Renal and hepatic impairment: no dose adjustment expected.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Presence of untreated localised infection involving the nasal mucosa, such as herpes simplex. Recent nasal surgery or trauma until wound healing has occurred.

Warnings and Precautions: Instances of nasal ulceration and nasal septal perforation have been reported. Not recommended in case of nasal septum perforation. Patients using Ryaltris over several months or longer should be examined periodically for possible changes in the nasal mucosa and for evidence of Candida infection. Instances of epistaxis have been reported. Visual disturbance may be reported with systemic and topical corticosteroid use. Consider referral to ophthalmologist with symptoms such as blurred vision or other visual disturbances as cataract, glaucoma or rare diseases such as central serous chorioretinopathy have been reported after use of systemic and topical corticosteroids. Hypersensitivity reactions, including wheezing, may occur - discontinue. Immunosuppression: use with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex. Potential systemic effects of corticosteroids include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Hypercorticism and adrenal suppression may appear at higher-than-recommended dosages or in susceptible individuals at recommended dosages - discontinue slowly. Increased risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis possible with concomitant use with other inhaled corticosteroids. Careful monitoring needed for acute adrenal insufficiency in response to stress in patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids. In patients with asthma or other conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of symptoms. Somnolence has been reported following administration of Ryaltris in clinical studies. Caution in patients operating machinery or driving a motor vehicle. Avoid concurrent use with alcohol or other central nervous system (CNS) depressants. Increased risk of antihistamine adverse effects with concomitant use of olopatadine or other antihistaminic drugs administered via nasal, ocular or oral route. Paediatric population: It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. Contains 0.02 mg benzalkonium chloride in each actuation. Benzalkonium chloride may cause

*Ryaltris™ is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis1

irritation or swelling inside the nose, especially if used for a long time.

Interactions: No interaction studies have been performed with Ryaltris. Any interactions from the combination of olopatadine and mometasone furoate are expected to reflect those of the components taken individually, no pharmacokinetic interaction between olopatadine and mometasone furoate was observed when administered in combination. Olopatadine: No interactions with other drugs expected. Mometasone Furoate: Cotreatment with CYP3A inhibitors should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects and patients should be monitored.

Pregnancy and Lactation: Avoid use during pregnancy unless potential benefit to mother justifies potential risk to mother, foetus or infant. Assess before prescribing in lactating mothers.

Side Effects: Common: dysgeusia, epistaxis, nasal discomfort. Uncommon: dizziness, headaches, somnolence, nasal dryness, dry mouth, abdominal pain, nausea, fatigue. Rare: bacterial vaginosis, anxiety, depression, insomnia, lethargy, migraine, blurred vision, dry eye, eye discomfort, ear pain, nasal inflammation, nasal mucosal disorder, oropharyngeal pain, sneezing, throat irritation, constipation, sore tongue, laceration.

Frequency not known: pharyngitis, upper respiratory tract infection, hypersensitivity (including anaphylactic reactions, angioedema, bronchospasm, dyspnoea), cataracts, glaucoma, increased intraocular pressure and nasal septum perforation.

Pack Sizes: One bottle containing 30ml suspension (240 actuations).

Legal Category: POM.

Product Authorisation Numbers: PA 1543/002/001

Product Authorisation Holder: Glenmark Pharmaceuticals s.r.o., Hvezdova 1716/2b, 140 78 Prague 4, Czech Republic.

Marketed by: A. Menarini Pharmaceuticals Ireland Ltd.

Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.

Date of Preparation: April 2025.

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 A. Menarini Pharmaceuticals Ireland Ltd. Phone no: 01 284 6744.

Two sprays per nostril twice daily (morning and evening)1

IR-RYL-05-2025 April 2025

1. Ryaltris™ Summary of Product Characteristics April 2025.

Building change through international partnership

Director of the HSE Global Health Programme Prof David Weakliam talks to Niamh Cahill about the importance of global healthcare and establishing meaningful collaborations with lower income countries

Prof David Weakliam, Director of the HSE Global Health Programme, first visited Africa over 40 years ago. In the decades since, global health has been an enduring feature of his career.

After studying medicine in Ireland, he initially trained as a GP. However, his growing interest in public health medicine ultimately led him to pursue a career in the specialty.

Several years were spent working in Africa and Asia before the now Adjunct Professor at University College Dublin settled back in Ireland.

On his return in 2003, he joined the Department of Foreign Affairs with Irish Aid, the Government’s overseas aid programme, where he served as a health advisor.

In 2007, Prof Weakliam was recruited to the HSE, playing a key role in establishing the Global Health Programme, launched in 2010.

The Programme emerged from an agreement between the HSE and Irish Aid, enabling the HSE both to support the group’s work in low- and middle-income countries and to strengthen its own global engagement.

“Health is very global,” Prof Weakliam told the Medical Independent (MI)

“Any health issue that we face in Ireland these days really has a global dimension and global connection. For anyone working in the health service, there’s a value in understanding health in a global way.”

The Covid-19 pandemic, he observed, underscored the extent to which health issues in one country affect others.

“I think we now very much appreciate, after the Covid pandemic, how much countries are interconnected when it comes to health,” he said.

Over the past 15 years, the Global Health Programme has steadily evolved and expanded. Prof Weakliam was its sole staff member until 2020; today, it has grown to a team of four.

Funded through Irish Aid via the Department of Foreign Affairs, as well as the Department of Health, the Programme supports work in low- and middle-income countries and in crisis settings, such as Ukraine, with a focus on strengthening health services and improving health outcomes.

Collaboration is at the heart of all its work, Prof Weakliam emphasised. This approach is reflected in partnerships with countries such as Ethiopia, Mozambique, Sudan, Tanzania, and Zambia.

“We respond when other countries request our assistance and we then build up links with those countries to understand

Prof David Weakliam

what their needs are and find out from them what they would like us to contribute to,” he explained.

“The old model of aid was that ‘we were the experts and we provide help to other countries’. That’s not the way we work anymore. We work as partners. Each country has its challenges and problems and we work together in a shared, equal way to learn from each other.”

Prof Weakliam said the Global Health Programme’s focus is often on lower income countries “because their health needs are very great”.

“[But] our approach is very much in terms of equality and a two-way exchange – what we can learn in Ireland as well as what we contribute. There is no doubt that we learn so much working with other countries.”

Mozambique

During a recent visit to Mozambique, Prof Weakliam and the Programme marked the 10-year anniversary of partnership with the nation.

“It’s very nice to see what’s been accomplished over the years,” Prof Weakliam told MI

“I met the Health Minister there and he is keen to continue the collaboration. It was good to get strong endorsement from their side that they wanted to continue the partnership.”

Mozambique was among the Global

Health Programme’s earliest partners.

The collaboration began when Mozambique’s Ministry of Health highlighted major challenges in the quality and safety of hospital care – areas it has since worked to improve with Ireland’s support.

Together with the Global Health Programme, they developed a training initiative with Irish clinicians travelling to Mozambique to support hospital staff. Teams there gained skills in quality improvement, from identifying and analysing problems and implementing practical measures to address them.

Mozambique has shortages of staff and

A wide range of problems were identified across hospitals, including high patient mortality rates after admission, elevated maternal deaths, long waiting times in emergency departments, delays for gynaecology outpatient appointments, and poor communication with patients.

The initiative helped to provide practical skills and learning, which has resulted in real improvements in care, according to Prof Weakliam.

“To give an example, one hospital was recording on average 11 deaths per month on their medical ward within 24 hours of admission,” he said.

“At the end of their training, and the project they implemented, they had reduced that to four a month. This was in 2017. Subsequently they saw a reduction from 58 deaths in a year in 2017 to eight deaths in 2019.”

Prof Weakliam said on his recent visit it was “very satisfying” to “see they are still sustaining those ongoing and continued benefits”.

He added that staff there continue to implement measures on an ongoing basis. The Global Health Programme visits

equipment in its hospitals, but addressing those deficits was not the objective of the initiative.

“We believe there is a lot staff can do themselves in their way of working,” Prof Weakliam said.

“Each hospital identified a particular challenge they faced around quality and they worked on that using the training that we provided with the Ministry of Health.”

For anyone working in the health service, there’s a value in understanding health in a global way

once a year to provide further coaching and training. Online training and coaching are also provided.

“In one hospital, when we visited last week, we saw they have established a whole department for improving quality of care, with staff assigned to work across the hospital improving care with quality coordinators,” Prof Weakliam said.

About 18 hospitals in Mozambique are now involved in the initiative.

In many cases, hospitals can demonstrate measurable improvements in patient care, from shorter waiting times to reduced mortality.

Maternal health

There is currently a concentrated focus in Mozambique on reducing maternal deaths, as the country has a very high maternal mortality rate.

In just one large hospital in Maputo, the capital, 38 maternal deaths were reported last year, according to Prof Weakliam.

Pictured L-to-R: Ms Ciara Norton, HSE Global Health Programme; Dr Elrasheid Kheirelseid, Consultant Vascular and Endovascular Surgeon, Beaumont Hospital, Dublin, and RCSI; and Prof David Weakliam

“The work that we’re doing with them will be to provide more training and support them to tackle that problem, which is solvable without them having to get lots of extra resources, if they can improve the way they provide care,” he explained.

Prof Weakliam highlighted the importance of the partogram in maternal health. This graphical tool is used during labour and delivery to track the progress of childbirth and monitor the wellbeing of both mother and baby.

“What’s important is that in doing this they are identifying women at risk of developing complications that could be serious and that allows them to intervene and take measures to prevent deaths.”

In the north of the country, in Niassa province, a project has been launched to reduce maternal mortality.

According to Prof Weakliam, all women in the project receive partogram monitoring and early results indicate a significant reduction in maternal deaths.

Despite Mozambique being a poor country with scarce resources, Prof Weakliam believes many problems in hospitals can be addressed through training and advice.

“It’s a very effective model because it doesn’t cost a lot when you look at all the potential benefits and lives saved. It’s a very small cost. It’s efficient and it’s sustainable. That’s the key thing for us – when improvements happen, that they are sustained.”

Zambia

In Zambia, the Global Health Programme works as part of the EQUALS Initiative with the RCPI. This is a joint initiative that seeks to improve healthcare and address healthcare inequalities by providing equipment and training.

The initiative commenced with Zambia, but has since been extended to Uganda and Ukraine. It began in response to a request from Zambia for medical equipment. Since 2014, the HSE has been sending containers of reusable medical equipment to Zambia every year.

“This is equipment that’s being replaced in our health service under our national equipment replacement programme that is no longer going to be used in Ireland and would otherwise be discarded or go back to the companies. We make that available for donation and we have been donating to Zambia for over 10 years now,” Prof Weakliam said.

Biomedical engineers working with Irish hospitals support training of engineers in Zambia to enable them to maintain the equipment, he added.

It was through this process that Prof Weakliam learned about efforts to develop a specialist postgraduate medical training programme for doctors in Zambia.

“What has been happening historically in Zambia, like most of Africa, is doctors leave the country in order to get their specialist training because it’s not available in their own country. But with that comes a brain drain and they [often] don’t go back,” Prof Weakliam said.

In 2017, Zambia established the Zambian College of Medicine and Surgery and through the EQUALS Initiative they requested support to develop a training programme.

“So, with our experience working with the RCPI, who have developed world-class training programmes in Ireland, we’ve been in a position to give them advice about how they might go about setting up a training programme,” he said.

“I was in Zambia in June for a graduation of the latest batch of doctors and this year they will have reached 388 specialists trained in 16 specialties. That’s an amazing achievement.

“We enabled them to put that programme in place. Last year we supported them with a small amount of funding and then with advice to develop their strategic plan for their training for the next five years. We tailor our support to what they request and need at a particular time.”

Crises

The Global Health Programme has responded and continues to respond to requests from countries for assistance in times of crises.

During the Covid pandemic, it facilitated the donation of Covid-related medical equipment to India and Nepal when they were experiencing high rates of Covid cases and when Ireland’s peak had passed.

“We had purchased a lot of equipment in the event that it might be needed and when it was identified that there was equipment no longer needed, we were able to donate that to countries like India and Nepal.

“Since then, we have been responding

at the request of other Government departments to crisis situations like the conflict in Ukraine and Sudan and we’ve been donating medical equipment to those two countries.”

In Ukraine, the Global Health Programme works with non-governmental organisations to help deliver medical equipment.

It also provides advice and supports the distribution of funding for the University College Dublin Ukraine Trauma Project, Prof Weakliam said.

“The project aims to provide emergency resuscitation training for a range of personnel working in conflict areas, but also for [civilians] to resuscitate people seriously injured and the funding for that is administered by our Programme,” Prof Weakliam stated.

In response to the crisis in Gaza, Ireland has brought sick children here for medical care; however, the Global Health Programme has not been directly involved in that aspect of support.

According to Prof Weakliam, the Programme has contributed in other ways.

“We have provisions within the HSE to release staff to work with other agencies for short-term assignments.”

He said that “under approved arrangements”, some staff have been deployed to countries near Gaza to provide specialist skills, such as epidemiology, as a result of the crisis.

Each country has its challenges and problems, and we work together in a shared, equal way to learn from each other

Learning at home

As Chair of the global health committee of the Forum of Irish Postgraduate Medical Training Bodies, Prof Weakliam has helped develop a global health curriculum that has been incorporated into specialist training programmes for doctors across all specialties.

The curriculum addresses topics including culture, epidemiology, diseases, climate change, sustainability, and health workforce and systems issues, highlighting the relevance of global health knowledge and skills for all health service workers.

It is also available as an e-learning module through the training bodies’ platforms, allowing doctors to further develop their expertise in the area.

In addition to his work on the curriculum, Prof Weakliam serves on committees such as the Ireland African Alliance for Non-Communicable Diseases and the UK and Ireland Global Cancer Network.

The Global Health Programme also collaborates with the Irish Global Health Network, which brings together people in Ireland and abroad with an interest in global health, facilitates knowledge sharing, organises events, and develops learning and training opportunities.

Prof Weakliam emphasises that much can be learned from other countries, particularly those with limited resources facing health challenges far greater than in Ireland, where the tools and support available are only a fraction of what exists here.

“That is very challenging for them [lower income countries]. They are forced to learn how to use resources to get the best results from their health system. That’s something we can learn, how to be resourceful with what you have. They are very innovative,” he maintained.

“One of the opportunities we have at this point, as the Programme is more established, is to systematically try to capture some learning from those countries and bring it into our own health service planning and strategy.”

Launch of the global health curriculum at the RCPI in 2023. Pictured are: Mr Eric O’Flynn; Ms Sinead Lucey; Prof Brian Kinirons; Prof David Weakliam; Prof Jean O’Sullivan; and Dr Diarmuid O’Shea

RCPI meeting to explore ‘healthcare horizons’

The College’s Annual Conference aims to challenge, inspire, and equip attendees to lead with purpose in an evolving medical landscape

The RCPI Annual Conference returns on 1416 October. It will bring together clinicians, educators, researchers, and thought leaders under the title of Healthcare Horizons: Inspire. Lead. Transform.

This flagship event is a call to action to healthcare professionals to add their voice as we reflect on the future of medicine and the evolving role of physicians in shaping equitable, innovative, and resilient healthcare systems.

Groundbreaking advances in medical training and education, clinical practice and care, are reshaping the future of medicine – enhancing outcomes for patients and empowering doctors to thrive in a rapidly changing medical landscape. Across three days, the conference will explore healthcare equity from access to treatment, diverse training and career pathways, the importance of clinical leadership, the evolution of disease, and the latest clinical pearls from leading specialists.

Speakers include:

▶ Ms Mary Robinson, former President of Ireland, Chair of the Elders, and climate and justice advocate.

▶ Prof Katriona O’Sullivan (PhD), Author of the bestselling memoir Poor.

▶ Dr Fiona Gallagher (PhD), Urban Historian, School of History and Geography, Dublin City University.

▶ Prof Robert Califf, Department of Medicine, Duke University, and former Commissioner of Food and Drugs, US Food and Drug Administration.

▶ Dr Colm Henry, HSE Chief Clinical Officer.

▶ Prof Mary Horgan, Interim Chief Medical Officer, Department of Health.

▶ Prof Andrew Elder, President, Royal College of Physicians of Edinburgh, UK.

The conference will take place at the College’s home, No 6, Kildare Street, Dublin, and will also be streamed online.

RCPI President Dr Diarmuid O’Shea emphasised that the gathering will inform attendees of how to shape the future of medicine through leadership, collaboration, and bold thinking.

“Healthcare is changing at an unprecedented pace,” Dr O’Shea said.

“This demands that postgraduate medical training bodies evolve, innovate, and prepare doctors not just for today’s challenges, but for tomorrow’s possibilities. This is a call to reimagine our roles together and build a future where innovation and equity go hand in hand.”

Advancing inclusive healthcare

Prof Katriona O’Sullivan will bring her powerful personal and professional insights to the RCPI public meeting on healthcare equity and inclusion health on Tuesday 14 October.

Drawing on her own journey from a childhood marked by poverty, homelessness, addiction, and exclusion to becoming an award-winning academic, Prof O’Sullivan will share her experiences and highlight ways to improve access to education and health services for all.

In Poor, Prof O’Sullivan reflects on the systemic barriers that shape lives long before opportunity ever arrives.

As she writes: “Being poor controls how you see yourself, how you trust and speak, how you see the world, and how you dream.”

Her story is a powerful reminder that resilience alone is not enough. Systemic barriers rooted in inequality, discrimination, and neglect hinder countless people in our society from accessing education, healthcare, opportunity, and dignity.

Following her talk, Prof O’Sullivan will be joined for a panel discussion by Prof Brendan Kelly, Consultant Psychi-

atrist; Dr Aoibhinn Walsh, Consultant Paediatrician; and Mr Paul Merrigan from the Inclusion Health Team at St James’s Hospital, Dublin. They will explore the systemic barriers to equitable healthcare, a framework to support physicians, and a path toward a more inclusive health service for all.

The evolution of cholera

On Wednesday 15 October, our heritage programme shines a light on cholera – a disease that, while now rare in Ireland, remains endemic in many regions of the world. The World Health Organisation has classified the period from 1961 to the present as the seventh cholera pandemic.

An expert panel will trace cholera’s journey from the first Irish outbreak in 1832, through its representation in literature to today’s efforts to eradicate the disease in Zambia.

The panel will feature Dr Fiona Gallagher, who will examine the spatial impact of the 1832 epidemic. Prof Geraldine Meaney (PhD), School of English, Drama and Film, University College Dublin, will explore cholera’s representation in literature, while Prof Viktor Mukonka, Professor of Public Health, will share his experience managing outbreaks in Zambia at different periods, such as during the 2017/18 cholera crisis and the Covid-19 pandemic.

After coffee, there will be a reading of Miasma , a play by Colin Murphy, inspired by Dr John Snow’s pioneering epidemiological research on the 1850s outbreak in London. The play explores issues around trust in science and pandemic response – themes that are as critical today as they were 170 years ago.

A special pop-up exhibition, featuring items from our heritage collections, showcasing the history of cholera in Ireland, will also be on display throughout the Annual Conference.

Empowering clinical leadership

St Luke’s Symposium is the flagship clinical event of the meeting and will be held on Thursday 16 October. It will deliver a thought-provoking programme with world-class speakers and networking opportunities for trainees, members, Fellows, and learners.

The programme will inform how we think about medical training, clinical leadership, and population health in the year ahead. We will explore the role of clinical leadership in

unlocking the future of healthcare and how training and practice are adapting to address the needs of doctors and the communities we care for, supported by new models of care. Discussions will centre around emerging population healthcare needs and threats and the intensifying challenges of climate change and health.

There will be an exclusive pre-recorded interview with Ms Mary Robinson, followed by a live panel discussion on the themes of leadership, climate, health, and global responsibility.

Next, doctors who have paved unconventional paths during their careers in medicine will share their stories. We will hear updates on the training landscape, and a keynote address from Prof Robert Califf, who will discuss the role of leadership in public health and explore how we can leverage population demographics to lead progress.

Prof Andrew Elder will speak about the evolving role of the doctor in modern medical practice.

He will be joined by Prof Pat Nash, Regional Clinical Director, HSE West North West, and Prof Richard Green, HSE Chief Clinical Information Officer, who will consider the evolution of digital innovations in healthcare.

Other speakers include Prof Dara Byrne, Professor of Simulation Education, School of Medicine, University of Galway, who will speak on clinical leadership in advancing practice, while Prof Mary Horgan will discuss population health needs and emerging threats. Finally, Dr Colm Henry will reflect on Sláintecare and the way forward in healthcare policy.

Our closing session will focus on clinical pearls and medical vignettes, including age-friendly healthcare, rewriting the script of penicillin allergy, integrating women’s health across medicine, and truth and power in science.

During the conference, the RCPI will welcome new Fellows and three new Honorary Fellows: Prof Andrew Elder, Prof Viktor Mukonka, and Prof Robert Califf.

Book your place here: https://web-eur.cvent.com/ event/5e2067b9-403f-4572-bfbd-5fb67a17c80a/ summary

Pictured L-to-R: Prof Diarmuid O’Donovan, HSE Director of National Health Improvement; and Dr Diarmuid O’Shea, RCPI President, at the St Luke’s Symposium 2024

Medical regulation under the spotlight in Dublin

Key issues in medical regulation and patient safety were highlighted at the recent International Conference on Medical Regulation in Dublin. e event held on 3-6 September, which attracted over 400 delegates from around the world, was organised by the International Association of Medical Regulatory Authorities and hosted by the Irish Medical Council.

e event o ered a deep insight into the evolution and challenges of medical regulation internationally through a series of presentations and workshops.

In a video address to delegates, Dr Tedros Adhanom Ghebreyesus, Director General, World Health Organisation, underlined the need to invest in regulation. He emphasised the important role of medical regulation for both patient safety and to enable the workforce to meet broader health system goals.

The health workforce was the backbone of any health system, stated Dr Ghebreyesus. He said ensuring the availability of health workers with the right competencies and skill-mix was fundamental to achieving universal health coverage.

Sessions on leadership and remediation emphasised that regulation must not dehumanise doctors. Delegates also heard about e orts to strengthen the voices of doctors and patients in the regulatory complaints process in Ireland.

e importance of training doctors from underrepresented groups, and training in marginalised communities, was also discussed. Training placements in rural areas, migrant communities, and prisons were cited as essential to tackling health inequalities, disparities in medical education and training,

The health workforce was the backbone of any health system, stated Dr Ghebreyesus

and improving population health.

During his address, which centred on ‘reflections from the political world’, former Taoiseach Mr Leo Varadkar said he believed open disclosure was still not “the norm” in Irish healthcare – despite the recent introduction of legislation in the area.

Mr Tiberius Pereira of Patients for Patient Safety Ireland spoke on the role of patient partnership. He underlined the requirement for timely, honest and full responses when things go wrong in healthcare – and supporting a culture of accountability and learning. This, in turn, generated greater trust in the system.

Dr Alan Clamp, CEO of the Professional Standards Authority (PSA), UK, gave an interesting insight into the Authority’s role as the ‘regulator of regulators’. e PSA oversees 10 health and social care regulators encompassing around two million registrants. It conducts an annual performance review of each regulator, including the General Medical Council, which is published on its website. Dr Clamp outlined that the PSA uses its standards of good regulation to encourage healthcare regulators to engage with patients. He said healthcare regulation exists to protect patients, and it is critical that patients are involved in its design, delivery, and evaluation.

Unsurprisingly, artificial intelligence (AI) in healthcare was a topic of much discussion – encompassing both doctors’ and regulators’ use of such technologies.

During the conference, the Medical Council also announced that it will soon publish a position paper on AI in Irish medicine. Ms Jantze Cotter, Executive Director of Regulatory Policy, Standards and Research, said the pace of AI development was accelerating at unprecedented rates in modern society, presenting novel opportunities and challenges.

Closing the conference, Dr Suzanne Crowe, President of the Medical Council, said doctors entered medicine to make a difference.

“Our discussions this week have shown that medical regulation can’t stand still. e overarching need for strong collaboration is also clear. We must focus on shared outcomes, rather than shared processes, to achieve people-focused regulation. is means taking concrete steps that will make a real di erence for doctors and patients. is is the spirit we must carry forward.”

READER COMMENTS

REACTION TO MR BARRY MCKENNA’S OPINION ARTICLE, ‘DRIVING GREENER PRACTICES AT ST JAMES’S’, 2 SEPTEMBER

“Congratulations to the great team in @stjamesdublin on their well-deserved ‘Green Flag’ award from @GreenCampusIE acknowledging all of their impressive achievements #SustainabilityInAction #SustainableHealthcare.”

An Taisce, @AnTaisce, 4 September

REACTION TO OUR NEWS FEATURE, ‘DEBATING THE NURSING HOME MODEL’, 2 SEPTEMBER

“@NursingHomesIre @kodonnellLK. This is a must read! Minister, you have ALL the control.” Jim Foley, @Jimcfoley, 3 September

REACTION TO OUR NEWS STORY, ‘MEDICAL COUNCIL TO MONITOR ETHNICITY AND DISABILITY DATA’, 19 AUGUST

“This is a welcome step of progress, albeit small and overdue.”

Dr Shubhangi Karmakar, LinkedIn, 22 August

REACTION TO OUR NEWS FEATURE, ‘A LIFETIME OF INNOVATION IN EYE CARE’, 19 AUGUST

“Congratulations on the publication, we are very pleased to have this book available in our library, very interesting read #proudtobepartofthehistory @HSEDubSouthEast @NAS_Waterford.” University Hosp Waterford, @UHW_Waterford, 29 August

“Thank you @med_indonews @PriscillaLynch. Mr Patrick Condon is among the guest speakers at ‘Eye Care in Focus’ Oct 1st Gibson Hotel, in conversation with #EyesOnTomorrow podcast hosts Dr John Ferris (Eye Doc) and Dermot Keogh (optometrist) https://eyedoctors.ie/eyecareinfocus/.”

Irish College of Ophthalmologists, @eyedoctorsIRL, 26 August

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DR AISLING NÍ SHÚILLEABHÁIN, Clinical Risk Advisor, Medisec

Medico-legal dilemmas in occupational health

Dr Aisling Ní Shúilleabháin provides advice on some challenging areas relating to occupational health

Doctors practising outside the specialty of occupational health – both GPs and consultants – will occasionally receive requests from patients to complete forms relating to different aspects of occupational health.

Medisec regularly assists members with queries ranging from basic pre-employment medicals and fitness-to-work certification, to full medical assessments, sometimes in contemplation of litigation, or as part of a grievance procedure. Often these are simple requests for advice, but on occasion members receive complaints from patients in relation to occupational health work. Certain issues arise repeatedly, and can involve:

▶ Confusion over who has access to reports – patient or employer;

▶ Consent to disclose information to employers;

▶ Recreational drugs – disclosure, and screening;

▶ Medical diagnoses arising in pre-employment medicals;

▶ Unsuitable wording on occupational health forms offered for completion. Occasionally, the employer and patient may have differing views or agendas and these can be challenging situations for doctors to navigate.

1. Who has access to reports?

The question of access to completed reports can cause confusion to doctors and patients alike. It is important that it is clear to both patient and doctor in advance of any assessment:

▶ Who has requested the report;

▶ The nature and extent of the advice to be reported upon;

▶ Where it will be sent;

▶ Who will ultimately have access to it. Difficulties can arise for a doctor who is both the patient’s usual healthcare provider and is acting on behalf of the employer (eg, to undertake a pre-employment medical, or a return-towork assessment).

The Faculty of Occupational Medicine of the RCPI in its Guidance on Ethical Practice for Occupational Health Physicians (‘the RCPI Guide’) quotes clearly: 1.2 “It is recognised that the practice of occupational medicine may at times place doctors in positions in which conflicts of interest or loyalty may arise as a consequence of their dual obligations. In all of their relationships with people, occupational physicians should understand the capacity in which they are acting at that time and ensure that other parties also understand that position. In particular, doctors giving occupational medical advice to companies where employees of the company may also be their patients should

ensure that the roles are distinct, separate, and that this is understood by all.”

Good practice dictates that in advance of any occupational assessment, a discussion is held with the patient and the situation clarified at the outset, and that the discussion is appropriately noted in the records. The discussion should include the purpose of the examination, the form that it will take, and the nature and extent of any information to be given to the employer.

2. Consent and extent of disclosure

The doctor should ensure that the patient consents to the process, and where possible, written consent should be obtained. If not, verbal consent should be recorded contemporaneously in the notes. Consent to undergo assessment and disclose clinical information is usually, but not always, forthcoming. If there is concern that the patient is under duress to present themselves for a medical assessment, the examining doctor should ensure that the patient does indeed consent to the assessment, and if clear consent does not ensue, the consultation should be terminated and further advice sought.

In an assessment for fitness-to-work, the advice and information given to the employer should be confined to ‘fit for work’, ‘unfit for work’, or ‘fit for work with certain accommodations’. Typically, the generic term ‘medical condition’ can be used. The details of the patient’s medical history and/or findings should not ordinarily be disclosed to the employer, except under exceptional circumstances and normally only with the express written consent of the employee.

Again, the RCPI Guide states:

2. “Individual clinical findings are confidential and information given to the employer should generally be confined to advice on ability and functional limitation.”

“.... More detailed information should only be disclosed with the consent of the employee. This latter course of action should only be in exceptional circumstances, in individual cases, where more detailed insights on the impact of the condition are necessary and appropriate to enable the employer to come to a decision.”

When an employer sends an employee for a review in the context of establishing the employee’s fitness-to-work, the employee will be entitled to receive a copy of the report prepared.

The Medical Council’s Guide to Professional Conduct and Ethics for Registered Medical Practitioners (2024) states that:

51.2 “You should be satisfied that the patient understands the purpose and scope of the report and of any examinations or investigations required to support its preparation and that the professional standards for consent and disclosure are followed.”

51.3 “The report should be confined to the purpose for which the report has been requested. You should inform the patient that you have a duty to the third-party as well as to the patient and that you cannot omit relevant information from the report.”

3. Contemplation of litigation

Where an employer is aware that an employee intends to initiate litigation arising out of an incident that occurred in the workplace, the employer, in engaging a doctor to prepare a report, may be entitled to assert legal privilege over any resulting report. Factors such as a verbal or written threat of litigation, or receipt of an initiating letter from the employee’s solicitors, would strongly support an employee’s right to assert legal privilege. In that scenario, the employee is not entitled to a copy of the report. However, the employee would ordinarily receive a copy of the employer’s litigation reports – for example, through disclosure and mutual exchange of reports – in the course of the litigation.

4. Storage and access to employee medical records

Doctors attending employees on-site should take extra care regarding security of confidential medical records. Records should not be accessible by management or staff. This remains true in cases of litigation, where the records should be only disclosed to the employer with the express informed consent of the employee or on foot of a court order. In order to provide truly informed consent, the employee should be advised in relation to whom the records

Remember that patient consent is almost always needed for disclosure of medical information to an employer

are likely to be disclosed. The RCPI Guide states: “Companies or their legal advisors or insurers have no automatic right of access to any medical records or reports.”

If the doctor ceases to provide occupational health services to the company, the records should be securely transferred to the new provider, and if the occupational health department ceases to operate, the records should be securely transferred to the patient’s GP – subject to the employee giving consent. In this circumstance, specific legal advice should be sought on the requirements around retention of occupational health data (eg, the Health and Safety Authority requires certain health surveillance records to be held for up to 40 years after the employee’s occupational exposure).

5. Drug screening

Many companies request that employees undergo regular screening for prohibited substances. As can be expected, this is an area beset with ethical complexities. Before agreeing to partake in such screening, the doctor should ensure that the employee is clear on what the company policies state and what they require regarding disclosure. The employee’s consent is still required, even if testing is required by law as per Section 13 of the Safety Health and Welfare at Work Act 2005, or other legislation.

6. Unexpected clinical findings

Where a doctor, in the process of performing an examination makes an unexpected clinical finding, they must act in the best interest of the patient and inform the patient of any follow-up investigations or treatment that may be necessary, whether with their own GP or a specialist. The fact that a doctor may be contracted by a company to prepare a report does not obviate the duty of care owed to the patient and appropriate follow-up should be arranged.

7. Standard forms

Occasionally a doctor will be presented with a pre-employment or other medical form that is unsuitable for the intended purpose. The doctor is not obliged to adhere to the exact questions and can give the information they see fit in accordance with appropriate standards of language, clinical practice, and confidentiality.

Conclusion

These are but a few of the aspects of occupational health, which can give rise to challenges for practitioners.

Any doctor who undertakes occupational health assessments and provides occupational health reports should, at the outset, clarify that both doctor and patient understand the reason for the assessment, the scope of the examination, what information may be disclosed, and the duty owed to all parties. Remember that patient consent is almost always needed for disclosure of medical information to an employer. Whenever there is doubt consider referring the employee for an independent occupational health assessment, and if guidance is needed, you should contact your indemnifier for advice.

References available on request

Horror in Gaza demands a response

Though we may feel powerless, it’s vital to act in the face of the atrocities we are witnessing

DR NEASA CONNEALLY

Almost two years into the war on Gaza, the devastation has surpassed even the darkest expectations. The death toll is beyond comprehension, famine is being engineered, and what unfolds amounts to the genocide of an entire nation – innocent men, women, and children

It’s hard to know what to do with the daily images of these horrors from my comfortable world where I will never want for a warm safe home to sleep in or for my next nourishing meal. I know plenty of people who endlessly share posts of atrocities on their social media feeds – I find myself wondering how healthy that can be or what that really achieves. However, everything we do from our safety here seems inadequate. In other humanitarian crises the most obvious response is to donate to the large NGOs and charities who can get aid to where it’s needed. In a conflict where food and basic supplies are being deliberately stopped at the border, it’s impossible to know how to respond as an individual.

Lobbying our Government also feels futile. Sure, it has been much stronger than other nations in words of solidarity since the start of this war, yet it can be argued that it has been very weak in terms of taking meaningful action that could potentially harm trade or relationships with

our biggest allies.

One feature of this conflict that is particularly monstrous is the deliberate targeting of our fellow healthcare workers and hospitals in actions which human rights organisations state may constitute war crimes. Israel is carrying out the systematic destruction of hospitals and targeting of particular individual doctors. As a result, Gaza is losing critical clinical knowledge and experience as well as the physical infrastructure which will be incredibly difficult to rebuild. It’s impossible to imagine the horrors that our colleagues are being subjected to, impossible to imagine the terror of working in a hospital in say, Dublin, Cork, or Galway while it’s under attack, all while not knowing if your family is still alive.

In Ireland, there is a growing movement to boycott the

use of medications made by an Israeli company where a viable alternative exists. The company is one of the largest suppliers of generic medicines in Ireland and is known to supply the Israeli military with medical supplies and donations. The movement is asking the HSE and hospital groups to remove products from their formularies, GPs not to prescribe, and for patients to request that pharmacies do not dispense these medications.

As a GP, I rarely think about the actual products that patients collect from the pharmacy once I write out their prescription, or where they come from.

One feature of this conflict that is particularly monstrous is the deliberate targeting of our fellow healthcare workers

But if this small act allows us to show solidarity with our Palestinian colleagues as well as signal to the world that we will not stand idly by, then I can only support it. I know that my asking the local pharmacy to dispense an alternative version is not going to make Benjamin Netanyahu suddenly sit up and stop the bombing and starvation. I’m sure there are people who would say that such actions are nothing more than ‘virtue signalling’ that only serve to make us feel better rather than achieve anything meaningful.

As a child, I remember learning in school about various wars, famines, and the Holocaust. I just couldn’t understand how they were not stopped by other nations who clearly knew what was happening. I couldn’t understand how they wouldn’t say ‘enough is enough’ and bring it all to an end.

One day, when international condemnation finally comes to bear and history looks back on these events, I may not be able to say I did very much – but at least I can say I did this.

Appreciating the small things (but not all the time)

Sometimes we need permission to be grumpy

Read more by Dr Sarah Fitzgibbon at www.mindo.ie

@SarahFitzWiMIN

What are the best things in life?

A clear run of green traffic lights on your usual route home.

A single successful swipe of nail varnish on a nail.

A perfect scoop of ice cream in a crisp cone.

Picking the most efficient passport queue.

Opening your book on the right page, even though your bookmark fell out.

A perfectly toasted marshmallow – crispy, gooey, and chewy all at the same time.

A moment in the garden when no one nearby is strimming/mowing/leaf-blowing/chainsawing or otherwise manhandling the silence.

The moment when your head hits your own pillow after days of sleeping in a strange bed.

Opening an optimal avocado.

Discovering your mandarin has not a single seed.

Hearing a long-lost song from your youth, while sitting in your car waiting for a child.

Babies’ heads.

A cup of tea at the top of a mountain.

A beer on a boat at 4pm.

Five minutes of bubblewrap popping.

A diagnostic discovery which turns out to be treatable. Opening the jam jar when others have failed. Blackberry jam.

These are all very individual and I realise not everyone will agree. I also accept that the syrupy “wellness” business of ‘Gratitude’ (has to have a capital G if you want to market it) and mindfulness and appreciating the little things in life is all very well and all very boring. Yes, yes, we know we are supposed to cherish every little rosebud that we see and marvel at the beauty of the raindrops gathering on the window, but God it can be hard work sometimes.

I live a life of extremes when it comes to seizing the day and all that. Some days I’m as ungrateful and intolerant as any angry radio DJ.

Other days I’m in floods of tears as I cradle a perfect

I live a life of extremes when it comes to seizing the day

strawberry in my hand.

How do we live our lives to the fullest, without killing ourselves in the process? Maybe lying on your bed in grubby pyjamas scrolling through TikTok is actually just as important as paddling along a palm-fringed beach with your perfectly dressed children shrieking in delight around you.

I am constantly bouncing from imminent death to endless life (mostly metaphorically, but sometimes literally) and the push and pull of it is exhausting. The guilt about not living every day to its absolute fullest is almost as consuming as the guilt that comes from wanting to wallow in my own misery for weeks on end. Neither of these options is fair on my children, who would presumably prefer a mother who trundles through life more concerned about managing her chin hairs than whether she will die before the chicken in the fridge goes out of date.

Taking pleasure from the small things in life does help me through some of the darker days and I do feel bad for people who are not filled with joy when they manage to return all of their plastic bottles without a single sticky reject hurling itself back out of the machine. Taking a moment to appreciate a satisfying burp can sometimes be the best part of my week. And a successful potshot of an apple core into the distant compost bin is almost unbeatable in its pleasure.

But sometimes we need permission to be grumpy and ungrateful and selfish. We need to allow ourselves the opportunity to take a day off from being a better person.

Then we can wake up again the next day and marvel at the wonder of a perfect soft-boiled egg.

Read more by Dr Neasa Conneally at www.mindo.ie

DR SARAH FITZGIBBON

Improving clarity and convenience in nAMD care

Real-world data confirms the efficacy, safety, and extended dosing benefit of VABYSMO (faricimab) in nAMD care

Age-related macular degeneration (AMD) is the primary cause of irreversible vision loss in people aged 50 and older in developed countries. In Ireland, AMD a ects approximately 7 per cent of those over 50 – a gure expected to rise with the ageing population.1

e disease thus places a signi cant burden on patients, families, and healthcare systems, both in terms of quality-of-life and healthcare resource use.

Advances in management

Treatment options for AMD have evolved considerably over recent decades. e introduction of anti-vascular endothelial growth factor (anti-VEGF) therapies has transformed the management of ‘wet’ neovascular AMD (nAMD).2 ese intravitreal agents target the pathological neovascularisation process, leading to reduced leakage and regression of abnormal vessels. is results in stabilisation or even improvement in visual acuity in many patients.3,4 Prior to anti-VEGF therapy and photocoagulation, a diagnosis of nAMD often meant inevitable and rapid vision loss. Many patients would become functionally blind within three to six months.4 e introduction of anti-VEGF agents has therefore marked a critical turning point, signi cantly reducing rates of severe vision impairment due to nAMD.2

“ e whole development of treatment for nAMD has revolutionised in my time,” Ms Patricia Quinlan, Consultant Ophthalmologist at Blackrock Health, a specialist in AMD, diabetic retinopathy and glaucoma, commented. “It is absolutely wonderful to have agents that work for this condition and are of tremendous bene t for patients.”

Patients with nAMD have bene ted from long-term vision preservation through regular intravitreal anti-VEGF injections. However, the intensive treatment regimen – requiring frequent injections and ongoing monitoring – places a substantial burden on patients and caregivers, particularly those travelling long distances. is demand also presents a growing capacity challenge for ophthalmology services, as patient numbers continue to rise, Ms Quinlan noted.

“So while we have excellent treatment, these agents have to be administered in a timely regular manner as required,” she said. “ e pressure is really on to pick up this condition before it results in huge irreversible loss of sight so this puts the pressure very much on the clinic to diagnose and treat. ere is huge strain on doctors and clinics as a result. Not to mention the commitment that is required from patients, who can be very elderly, and also their carers and families who may often have to take a day o work to bring them to their appointment so it is a

lot of pressure on everybody.”

Unsurprisingly, there is now a lot of interest in trying to reduce the burden of nAMD care on clinics, patients, and their families. e introduction of VABYSMO ▼ (faricimab),3 the rst bispeci c monoclonal antibody (see tinted panel), represents a signi cant breakthrough in the treatment of nAMD: Delivering e cacy, durability, and reduced care burden.

Data from international phase 3 clinical studies con rm its clinical e cacy and safety pro le,3,4 while demonstrating meaningful reductions in treatment frequency. is not only bene ts patients – by lowering injection burden and improving adherence – but also helps alleviate the growing

turing how treatments perform in routine clinical settings, across broader and more diverse patient populations. is is particularly important for chronic conditions like nAMD, where long-term e ectiveness, safety, and treatment burden are key considerations.

Clinical trial data with anti-VEGF therapies has not always been replicated in clinical practice.

However, beyond the positive trial data,4 VABYSMO has shown promising real-world outcomes since its introduction. e widespread use of VABYSMO since 2022 (over eight million doses administered globally)6 means there is now a wealth of real-world data in both extended follow-up studies

Without question the benefit of VABYSMO is not only effective, as it works on two pathways, it allows greater extension between the treatments so the patient has to come in less frequently

pressure on ophthalmology services.

Ms Quinlan has extensive experience in treating patients with nAMD, from the original anti-VEGF agents to VABYSMO.

“Without question the bene t of VABYSMO is not only e ective, as it works on two pathways, it [through fast drying] allows greater extension between the treatments so the patient has to come in less frequently for their assessments and injections. at is a huge bene t to everybody and it is very reassuring to know that it is a reliable treatment, so we can trust that it allows us that treatment extension.”

Importance of real-world evidence

Real-world evidence plays a vital role in complementing clinical trial data by cap-

and real-life clinical use to con rm its efcacy and extend to treat potential. VABYSMO is supported by a real-world data programme of >200,000 (nAMD and DME) patients. is includes eight ongoing real-world studies (eg, VOYAGER, FARWIDE nAMD & DME, FARETINA nAMD & DME, FaREAL, FARSEEING, PASSENGER) in 38 countries, including FaREAL sites in Ireland.7-14 ese data give crucial insight into under-served patient populations; excluded trial cohorts, comorbidities, and heavily pre-treated patients.

“Real-world evidence is where it’s at. We all look for guidance from the clinical trials and they are hugely important, but it is very encouraging to see how that translates into day-to-day clinic activity where

the patients are not selected [per strict trial protocols] and you see the real-world situation,” Ms Quinlan said. She acknowledged that when a new agent comes on stream, people are understandably cautious initially. Like many ophthalmologists, Ms Quinlan started by transitioning non or poor responders to other nAMD treatments on to VABYSMO and following good results extended her use to other already-treated and treatment-naive nAMD patients. “I would use it rst-line now quite a lot. As you use it more, you gain more con dence.”

As well as the reduced travel burden for nAMD patients and caregivers, she said another bene t is that the longer treatment intervals facilitated by VABYSMO can be useful if a patient is delayed by a week or so in having their scheduled injection due to illness. “ ese patients are often very elderly, frail, and can have many co-morbidities. at exibility is thus an important bene t with VABYSMO.”

Showcasing real-world use of VABYSMO Ms Quinlan chaired a special dedicated session on the real-world use of VABYSMO at the Irish College of Ophthalmologists Annual Conference in Kilkenny on 22 May. e session gave a refresher on the results of the phase 3 clinical trials for VABYSMO, discussed the importance of real-world data in retinal diseases and the impact on real-world clinical practice and speakers shared their real-world experiences of VABYSMO from UK and Ireland.

Mr Robin Hamilton, Consultant Ophthalmologist, Moor elds Eye Hospital, London, UK, outlined how VABYSMO works, and shared his, and his colleagues, extensive real-world experience of using the agent, presenting data from a number of studies examining the use of VABYSMO in nAMD patients at Moor elds. “ e real-world durability of VABYSMO in treatment-naïve patients re ects clinical trial data,” he commented, comparing the results of clinical trials and UK real-world data.

Pooled analysis of data from TENAYA/ LUCERNE3,4 showed 80 per cent of treatment-naïve patients with nAMD treated

Ms Patricia Quinlan

Mr Robin Hamilton

Mr Tomas Burke

with VABYSMO achieved extended treatment intervals of Q12W by year one, while 75 per cent of treatment-naïve patients with nAMD treated with VABYSMO achieved extended treatment intervals in the real-world (pooled Liverpool and Moor elds data),15,16 Mr Hamilton outlined.

A two-year follow-up study in Moor elds showed there were good visual acuity and CST outcomes in treatment-naïve nAMD patients (n=141), with 67 per cent of patients on treatment intervals ≥Q12W or extended to monitoring due to disease stability at 24 months.17

“If you look at the data and at the end of year two – you have nearly 90 per cent of patients beyond eight-weekly injections. at is an incredible number and that is certainly going to reduce patient and caregiver time, clinic time, and costs,” Mr Hamilton said.

Other Moor elds data showed that the use of VABYSMO led to stable visual acuity outcomes and robust drying e ect with extension of treatment intervals in the majority of high-frequency use, previously-treated nAMD patients.18 e data also con rms that VABYSMO’s safety pro le was comparable to registration trials in terms of the incidence of intraocular in ammation (one-year follow-up of 1,860 nAMD and DME patients).19

“So if you look at the data on those who switched [to VABYSMO], after a year, these patients are not losing vision,” he said. e need for less frequent nAMD treatment has seen a clear bene t to patients, caregivers, sta , and the service at Moor elds, Mr Hamilton said, point-

ing out that demand for nAMD and DME care continues to grow, and that while Moor elds is a very large unit this is a signi cant challenge.

“If you look at our projections for this year, we will give potentially 65,000 injections [in Moor elds] and if we can even drop that down to 60,000, that gives us breathing space for a year to 18 months before the numbers go back up again because of the ageing population and increasing number of diagnoses.”

Not every nAMD patient is suitable for treatment interval extension, he acknowledged, stressing the need for an individualised approach.

“ ere is no one size ts all approach for every patient. You must tailor the approach to each patient,” Mr Hamilton emphasised.

“Yes, there are some patients who you will not be able to extend the intervals for, who will still require four-weekly injections, but if you are reducing the burden en masse, it means your clinic can cope with those patients.”

Looking to the future, Mr Hamilton said extending treating intervals for VABYSMO beyond 12 weeks to 16 weeks, and even further, is now being studied, at both real-world and clinical trial level and he looks forward to seeing how that goes.

Real-world Irish experience

Mr Tomas Burke, Consultant Ophthalmologist and Ophthalmic Surgeon at Mater Private Network and Bons Secour Hospital, Dublin, attended the VABYSMO session at the ICO Conference in

VABYSMO: The science and data

VABYSMO is the first intraocular bispecifi c antibody that acts through inhibition of two distinct pathways by neutralisation of both angiopoietin-2 (Ang-2) proteins and vascular endothelial growth factor-A (VEGF-A). 3,4

By independently blocking both pathways involving Ang-2 and VEGF-A, VABYSMO is designed to stabilise blood vessels and thereby reduce inflammation, leakage and abnormal vessel growth (neovascularisation) more than inhibition of VEGF-A alone. 3,4

The phase 3 clinical trials (TENAYA/ LUCERNE)3,4 and real-world findings7 of VABYSMO confirm that dual Ang-2/ VEGF-A pathway inhibition may result in greater disease control versus anti-VEGF alone, potentially reducing treatment burden, and improving real-world outcomes and compliance in retinal vascular diseases.

The dual mechanism also appears to provide faster disease control, with post-hoc analysis from the LUCERNE and TENAYA trials showing 75 per cent of VABYSMO-treated eyes achieving absence of fluid (resulting in vision stability and tight anatomic control) within two injections, compared to three

injections with aflibercept.20

Vabysmo's safety profile has been shown to be comparable to available anti-VEGF agents in phase 3 clinical trials. 3,4 Now, considerable real-world evidence is demonstrating that the safety findings from clinical studies are replicated in real-world clinics, both from sponsored real-world studies, as well as independent cohort studies.18,19

The therapeutic advantages of less injections into the eye, and therefore reduced risk of side-effects and complications, in a disease that needs continuous ongoing treatment, is also an important advantage.

Initial treatment with VABYSMO typically involves monthly injections for the first four months, which can be followed by less frequent dosing based on the patient’s individual response and disease activity.5 Many patients can achieve stable vision with dosing intervals of up to 16 weeks,5 which is a significant improvement over the typically more frequent dosing required by other anti-VEGF therapies.

In 2022, the UK’s National institute for Health and Care Excellence recommended VABYSMO as an option

Kilkenny. He is now treating many of his nAMD patients with VABYSMO, both treatment-naïve and those who have been receiving anti-VEGF injections for many years.

“I’ve certainly been impressed from my own experience of using it in both groups,” he said. “From the initial clinical trial data and now from real-world experience; the drying [of retinal uid] is very fast and the visual results appear to be maintained, which is really encouraging.”

As well as the visual acuity improvements, the extended intervals in dosing is a key bene t, Mr Burke agrees. “ e bene ts of fewer injections are multiple – from fewer visits to the clinic for the patient, and the family or friends bringing them to their appointments, and some of them have long journeys. As well as less risk to the eye, with less injections.”

ere are also bene ts from an environmental and sustainability point of view, Mr Burke noted, with less travel, and less packaging and consumables associated with fewer visits.

“Fewer injections with the same visual outcomes compared to the previous standard of care is a major bene t.”

Mr Burke said he is looking forward to seeing longer-term real-world data on VABYSMO to support its increased use in nAMD care.

“For new patients we can now reference the clinical trials and the real-world data when discussing the option of VABYSMO with them. My own experience of VABYSMO has been very positive, and in the future there will be more data to show if those visual gains and the drying

to treat adult patients with neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DMO), noting it had been shown to be effective in improving vision or reducing vision loss in these patient groups, but had the added benefit in that it could be given less frequently in selected patients than the other medicines currently available for treating nAMD.21

In Ireland, VABYSMO is available privately and is covered for suitable patients by health insurance.

Ireland recently became the first country to recruit patients as part of the new global FaReal study to evaluate the effectiveness, safety, clinical insights, and treatment patterns of VABYSMO in the real-world treatment of nAMD or DMO in at least one eye. The study is taking place in real-world clinical environments over a two-year period.

The study is being conducted at the Institute for Eye Surgery, UMPC Whitfield Hospital in Waterford and has already recruited the first patients. In total, close to 50 Irish patients will be included in the trial in Waterford and three other sites across Ireland as part of an expected trial of 850 patients across 17 countries.12,22

are maintained over a number of years.” Ms Quinlan, Mr Hamilton, and Mr Burke all noted that demand for nAMD care is increasing as our population grows and ages and the number of cases rises and that solutions to this are needed, which is where VABYSMO can play a part.

Conclusion

e evolution of nAMD treatment has delivered major clinical bene ts for patients, with VABYSMO taking the next step by combining e cacy with reduced injection frequency. Real-world data, including early Irish ndings, strongly support its role in reducing patient burden and helping address the growing demand of nAMD care on ophthalmology services.

Roche financially supported the publication of this article.

References

1. Fighting Blindness: AMD. Available at: www. fightingblindness.ie/living-with-sight-loss/eyeconditions/age-related-macular-degenerationamd/ [accessed August 2025]

2. Averty RL. Retina Today. May/June 2021. Available at: https://retinatoday.com/ articles/2021-may-june/anti-vegf-therapy-pastpresent-and-future [accessed August 2025]

3. Agostini H, et al. Graefes Arch Clin Exp Ophthalmol 2024;262:3437–3451

4. Heier JS, et al. Lancet 2022;399:729–40

5. VABYSMO 120mg/mL solution for injection and VABYSMO 120mg/mL solution for injection in pre-filled syringe, SmPC, available at www.medicines.ie

6. Data on file

7. VOYAGER Study. Available at: clinicaltrials.gov/study/NCT05476926 [accessed August 2025]

8. McKibbin M, et al. EURETINA 2024

9. Peto T, et al. EURETINA 2024

10. Borkar D, et al. ARVO 2025. Poster 3108

11. Singh RP, et al. ARVO 2025

12. FaReal Study. Available at: clinicaltrials.gov/ study/NCT06680817 [accessed August 2025]

13. FARSEEING Study. Available at: clinicaltrials.gov/study/NCT06439576 [accessed August 2025]

14. Paul-Ehrlich-Institut. pei.de/Shared Docs/awb/nis-0701-0800/0711 [ accessed August 2025]

15. Sim SY, et al. ARVO 2024. 246- B0309

16. Babiker S, et al. ARVO 2024

17. Sim YS, et al. ARVO Abstract 2025

18. Sim YS, et al. Ophthalmol Retina 2025;9(1):22–30

19. Montesel A, et al. Retina 2025;45(5)827-832

20. Roche Press release. Available at: www.roche.com/media/releases/medcor-2023-04-25 [accessed August 2025]

21. NICE. Available at: www.nice.org.uk/ guidance/ta800 [accessed August 2025]

22. Ireland Leads The Way With New Global Eye Study. Available at: www.roche.ie/stories/eyestudy [accessed August 2025]

Additional references available on request

Number: M-IE-00002215 Date of Preparation: September 2025

Veeva

Prefilled Syringe1

Ready for an upgrade?2 VABYSMO (faricimab)

Ready for an upgrade?2 VABYSMO (faricimab) Prefilled Syringe1

VABYSMO is indicated for the treatment of adult patients with: neovascular (wet) age-related macular degeneration (nAMD),

VABYSMO is indicated for the treatment of adult patients with:

• visual impairment due to diabetic macular oedema (DME),

• neovascular (wet) age-related macular degeneration (nAMD),

• visual impairment due to diabetic macular oedema (DME),

• visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).1

THIS MATERIAL IS INTENDED FOR HEALTHCARE PROFESSIONALS WORKING IN IRELAND ONLY.

References: 1. VABYSMO 120 mg/mL solution for injection and VABYSMO 120 mg/mL solution for injection in pre-filled syringe, Summary of Product Characteristics, available at www.medicines.ie. 2. UzzanJ, et al. Clinical Outcomes and Experiences with Prefilled Syringes Versus Vials for Intravitreal Administration of Anti‑VEGF Treatments: A Systematic Review. Ophthalmol Ther 2024; 13:2445 2465. Date of item: August 2025. M IE 00002216 (v 1.0)

• visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).1 THIS MATERIAL IS INTENDED FOR HEALTHCARE PROFESSIONALS WORKING IN IRELAND ONLY.

References: 1. VABYSMO 120 mg/mL solution for injection and VABYSMO 120 mg/mL solution for injection in pre-filled syringe, Summary of Product Characteristics, available at www.medicines.ie. 2. UzzanJ, et al. Clinical Outcomes and Experiences with Prefilled Syringes Versus Vials for Intravitreal Administration of Anti‑VEGF Treatments: A Systematic Review. Ophthalmol Ther 2024; 13:2445 2465. Date of item: August 2025. M IE 00002216 (v 1.0)

ABRIDGED PRESCRIBING INFORMATION (API)

ABRIDGED PRESCRIBING INFORMATION (API)

For full prescribing information refer to the Summary of Product Characteristics [SmPC]

For full prescribing information refer to the Summary of Product Characteristics [SmPC]

Vabysmo®▼(faricimab) 120 mg/mL solution for injection

Vabysmo®▼(faricimab) 120 mg/mL solution for injection

Vabysmo®▼ (faricimab) 120 mg/mL solution for injection in pre-filled syringe ▼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 box below for details on how to report. Therapeutic Indications: Vabysmo is indicated for the treatment of adult patients with: neovascular (wet) age related macular degeneration (nAMD); visual impairment due to diabetic macular oedema (DME); visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO). Posology and Method of Administration: This medicinal product must be administered by a qualified physician experienced in intravitreal injections. Posology: Monitoring between dosing visits should be scheduled based on patient’s status and at the physician’s discretion. nAMD: the recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses. Thereafter, an assessment of disease activity based on anatomic and/or visual outcomes is recommended 16 and/or 20 weeks after treatment initiation so that treatment can be individualised. In patients without disease activity, administration of Vabysmo every 16 weeks (4 months) should be considered. In patients with disease activity, treatment every 8 weeks (2 months) or 12 weeks (3 months) should be considered. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reduction should be implemented if anatomic and/or visual outcomes deteriorate. There is limited safety data on treatment intervals of 8 weeks or less between injections. DME and RVO: The recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly); 3 or more consecutive, monthly injections may be needed. Thereafter, treatment is individualised using a treat and extend approach. Based on the physician’s judgement of the patient’s anatomic and/or visual outcomes, the dosing interval may be extended in increments of up to 4 weeks. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reduction should be implemented if anatomic and/or visual outcomes deteriorate. Treatment intervals shorter than 4 weeks and longer than 4 months between injections have not been studied. Method of administration: Refer to Vabysmo SmPC and package leaflet for full administration details and instructions for use. Vabysmo is for intravitreal use only. Each vial or pre filled syringe (PFS) should only be used for the treatment of a single eye. Vabysmo should be inspected visually for particulate matter and discoloration prior to administration, and if present, the PFS or vial should not be used. Proper aseptic injection techniques

Vabysmo®▼ (faricimab) 120 mg/mL solution for injection in pre-filled syringe ▼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 box below for details on how to report. Therapeutic Indications: Vabysmo is indicated for the treatment of adult patients with: neovascular (wet) age related macular degeneration (nAMD); visual impairment due to diabetic macular oedema (DME); visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO). Posology and Method of Administration: This medicinal product must be administered by a qualified physician experienced in intravitreal injections. Posology: Monitoring between dosing visits should be scheduled based on patient’s status and at the physician’s discretion. nAMD: the recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses. Thereafter, an assessment of disease activity based on anatomic and/or visual outcomes is recommended 16 and/or 20 weeks after treatment initiation so that treatment can be individualised. In patients without disease activity, administration of Vabysmo every 16 weeks (4 months) should be considered. In patients with disease activity, treatment every 8 weeks (2 months) or 12 weeks (3 months) should be considered. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reduction should be implemented if anatomic and/or visual outcomes deteriorate. There is limited safety data on treatment intervals of 8 weeks or less between injections. DME and RVO: The recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly); 3 or more consecutive, monthly injections may be needed. Thereafter, treatment is individualised using a treat and extend approach. Based on the physician’s judgement of the patient’s anatomic and/or visual outcomes, the dosing interval may be extended in increments of up to 4 weeks. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reduction should be implemented if anatomic and/or visual outcomes deteriorate. Treatment intervals shorter than 4 weeks and longer than 4 months between injections have not been studied. Method of administration: Refer to Vabysmo SmPC and package leaflet for full administration details and instructions for use. Vabysmo is for intravitreal use only. Each vial or pre filled syringe (PFS) should only be used for the treatment of a single eye. Vabysmo should be inspected visually for particulate matter and discoloration prior to administration, and if present, the PFS or vial should not be used. Proper aseptic injection techniques

must always be used when administering Vabysmo. PFS: The PFS contains an excess of volume expel excess before injecting the recommended dose otherwise it could result in overdose. To expel the air bubbles along with excess medicinal product, slowly push the plunger rod until the lower edge of the rubber stopper’s dome is aligned with the 0.05 mL dose mark (refer to SmPC). Insert the injection filter needle (included in the package) 3.5 to 4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 mL is then delivered slowly; a different scleral site should be used for subsequent injections. Vial: The injection needle (30 gauge x ½ inch, not included in the package) should be inserted 3.5 to 4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 ml should be delivered slowly; a different scleral site should be used for subsequent injections. Post-injection monitoring: Following injection, patients should be monitored for elevation in intraocular pressure. Treatment duration: Vabysmo is intended for long term treatment. If visual and/or anatomic outcomes indicate that the patient is not benefitting from continued treatment, treatment should be discontinued. Delayed/ Missed Doses: If a dose is delayed or missed, the patient should return to be assessed by physician at the next available visit and continue dosing depending on physician’s discretion. Special Populations: No dose adjustment is required in renal/hepatic impaired patients or patients ≥ 65 years. Safety data in nAMD and RVO patients ≥ 85 years is limited. There is no relevant use in the paediatric population. Contraindications: Hypersensitivity to faricimab or to any of the excipients listed in the SmPC. Active or suspected ocular or periocular infections. Active intraocular inflammation. Special Warnings and Precautions for Use: Refer to Vabysmo SmPC for full details. Traceability: in order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Intravitreal injection related reactions: intravitreal injections, including those with faricimab, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract. Patients should be instructed to report any symptoms, such as pain, loss of vision, photophobia, blurred vision, floaters, or redness, suggestive of endophthalmitis or any of the above mentioned adverse reactions without delay. Patients with increased frequency of injections may be at increased risk of procedural complications. Intraocular pressure increases: transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including those with faricimab. Special precaution is needed in patients with poorly controlled glaucoma (do not inject Vabysmo while the IOP is ≥ 30 mmHg). In all cases, both the IOP and perfusion of the optic nerve head must be monitored and managed appropriately. Systemic effects: systemic adverse events including arterial thromboembolic events have been reported following intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors. A low incidence rate of arterial thromboembolic events was observed in the Vabysmo clinical trials. This is similar to that reported in the other clinical trials with anti VEGF inhibitors in patients. Refer to SmPC for full details. Immunogenicity: there is a potential for immunogenicity. Patients should be instructed to inform their physician of any signs or symptoms of intraocular inflammation such as vision loss, eye pain, increased sensitivity to light, floaters or worsening eye redness, which might be a clinical sign

must always be used when administering Vabysmo. PFS: The PFS contains an excess of volume expel excess before injecting the recommended dose otherwise it could result in overdose. To expel the air bubbles along with excess medicinal product, slowly push the plunger rod until the lower edge of the rubber stopper’s dome is aligned with the 0.05 mL dose mark (refer to SmPC). Insert the injection filter needle (included in the package) 3.5 to 4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 mL is then delivered slowly; a different scleral site should be used for subsequent injections. Vial: The injection needle (30 gauge x ½ inch, not included in the package) should be inserted 3.5 to 4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 ml should be delivered slowly; a different scleral site should be used for subsequent injections. Post-injection monitoring: Following injection, patients should be monitored for elevation in intraocular pressure. Treatment duration: Vabysmo is intended for long term treatment. If visual and/or anatomic outcomes indicate that the patient is not benefitting from continued treatment, treatment should be discontinued. Delayed/ Missed Doses: If a dose is delayed or missed, the patient should return to be assessed by physician at the next available visit and continue dosing depending on physician’s discretion. Special Populations: No dose adjustment is required in renal/hepatic impaired patients or patients ≥ 65 years. Safety data in nAMD and RVO patients ≥ 85 years is limited. There is no relevant use in the paediatric population. Contraindications: Hypersensitivity to faricimab or to any of the excipients listed in the SmPC. Active or suspected ocular or periocular infections. Active intraocular inflammation. Special Warnings and Precautions for Use: Refer to Vabysmo SmPC for full details. Traceability: in order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Intravitreal injection related reactions: intravitreal injections, including those with faricimab, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract. Patients should be instructed to report any symptoms, such as pain, loss of vision, photophobia, blurred vision, floaters, or redness, suggestive of endophthalmitis or any of the above mentioned adverse reactions without delay. Patients with increased frequency of injections may be at increased risk of procedural complications. Intraocular pressure increases: transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including those with faricimab. Special precaution is needed in patients with poorly controlled glaucoma (do not inject Vabysmo while the IOP is ≥ 30 mmHg). In all cases, both the IOP and perfusion of the optic nerve head must be monitored and managed appropriately. Systemic effects: systemic adverse events including arterial thromboembolic events have been reported following intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors. A low incidence rate of arterial thromboembolic events was observed in the Vabysmo clinical trials. This is similar to that reported in the other clinical trials with anti VEGF inhibitors in patients. Refer to SmPC for full details. Immunogenicity: there is a potential for immunogenicity. Patients should be instructed to inform their physician of any signs or symptoms of intraocular inflammation such as vision loss, eye pain, increased sensitivity to light, floaters or worsening eye redness, which might be a clinical sign

INDICATIONS PATHWAYS CHOICE Roche C4 NJ

INDICATIONS PATHWAYS CHOICE

Make VABYSMO your first choice

attributable to hypersensitivity against Vabysmo. Bilateral treatment: the safety and efficacy of Vabysmo administered in both eyes concurrently have not been studied. As such there is a theoretical risk for bilateral ocular adverse reactions and/or systemic adverse reactions. Concomitant use of other anti-VEGF: there are no data available on the concomitant use of Vabysmo with anti VEGF medicinal products in the same eye. Vabysmo should not be administered concurrently with other anti VEGF medicinal products (systemic or ocular). Use of other injection needles with the PFS: Only use the PFS with the co packaged injection filter needle. No clinical data available on the use of other injection needles with the PFS. Withholding treatment: treatment should be withheld in patients with: Rhegmatogenous retinal detachment, stage 3 or 4 macular holes, retinal break; treatment should not be resumed until an adequate repair has been performed; treatment related decrease in Best Corrected Visual Acuity (BCVA) of ≥ 30 letters compared with the last assessment of visual acuity; treatment should not be resumed earlier than the next scheduled treatment; an intraocular pressure of ≥ 30 mmHg; a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥ 50%, of the total lesion area; performed or planned intraocular surgery within the previous or next 28 days; treatment should not be resumed earlier than the next scheduled treatment. Retinal pigment epithelial (RPE) tear: Refer to SmPC. Caution should be used when initiating Vabymso in patients with risk factors for RPE tears. RPE tears are common in nAMD patients with PED, treated with intravitreal anti VEGF agents including Vabysmo. There was a higher rate of RPE tear in the Vabysmo group (2.9%) compared to aflibercept group (1.5%). Populations with limited data: there is only limited experience in the treatment of nAMD and RVO patients ≥ 85 years, and DME patients with type I diabetes, patients with HbA1c over 10%, patients with high risk proliferative diabetic retinopathy (DR), high blood pressure (≥ 140/90 mmHg) and vascular disease, sustained dosing intervals shorter than every 8 weeks (Q8W), or patients with active systemic infections. There is limited safety information on sustained dosing intervals of ≤Q8W and these may be associated with a higher risk of ocular and systemic adverse reactions, including serious adverse reactions. There is also no experience of treatment with Vabysmo in diabetic or RVO patients with uncontrolled hypertension and patients with RVO who have failed previous therapy. This lack of information should be considered by the physician when treating such patients. Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per dose. Polysorbate content: This medicinal product contains 0.02 mg of polysorbate per 0.05 mL dose. Patients with hypersensitivity to polysorbate should not take this medicine. Educational materials: Prescribers should be familiar with the patient guide prepared to ensure awareness of signs and symptoms of intraocular inflammation and endophthalmitis and provide this to the patient/caregiver explaining these events. Interactions: No interaction studies have been performed. However, Vabysmo should not be administered concurrently with other systemic or ocular anti VEGF medicinal products. Fertility, Pregnancy and Lactation: Women of childbearing potential: should use effective contraception during treatment and for at least 3 months following the last intravitreal injection. Pregnancy: there are no or limited amount of data in pregnant women. Vabysmo must be regarded as potentially teratogenic and embryo /foetotoxic and should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus. Breast-feeding: it is unknown whether faricimab is excreted in

attributable to hypersensitivity against Vabysmo. Bilateral treatment: the safety and efficacy of Vabysmo administered in both eyes concurrently have not been studied. As such there is a theoretical risk for bilateral ocular adverse reactions and/or systemic adverse reactions. Concomitant use of other anti-VEGF: there are no data available on the concomitant use of Vabysmo with anti VEGF medicinal products in the same eye. Vabysmo should not be administered concurrently with other anti VEGF medicinal products (systemic or ocular). Use of other injection needles with the PFS: Only use the PFS with the co packaged injection filter needle. No clinical data available on the use of other injection needles with the PFS. Withholding treatment: treatment should be withheld in patients with: Rhegmatogenous retinal detachment, stage 3 or 4 macular holes, retinal break; treatment should not be resumed until an adequate repair has been performed; treatment related decrease in Best Corrected Visual Acuity (BCVA) of ≥ 30 letters compared with the last assessment of visual acuity; treatment should not be resumed earlier than the next scheduled treatment; an intraocular pressure of ≥ 30 mmHg; a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥ 50%, of the total lesion area; performed or planned intraocular surgery within the previous or next 28 days; treatment should not be resumed earlier than the next scheduled treatment. Retinal pigment epithelial (RPE) tear: Refer to SmPC. Caution should be used when initiating Vabymso in patients with risk factors for RPE tears. RPE tears are common in nAMD patients with PED, treated with intravitreal anti VEGF agents including Vabysmo. There was a higher rate of RPE tear in the Vabysmo group (2.9%) compared to aflibercept group (1.5%). Populations with limited data: there is only limited experience in the treatment of nAMD and RVO patients ≥ 85 years, and DME patients with type I diabetes, patients with HbA1c over 10%, patients with high risk proliferative diabetic retinopathy (DR), high blood pressure (≥ 140/90 mmHg) and vascular disease, sustained dosing intervals shorter than every 8 weeks (Q8W), or patients with active systemic infections. There is limited safety information on sustained dosing intervals of ≤Q8W and these may be associated with a higher risk of ocular and systemic adverse reactions, including serious adverse reactions. There is also no experience of treatment with Vabysmo in diabetic or RVO patients with uncontrolled hypertension and patients with RVO who have failed previous therapy. This lack of information should be considered by the physician when treating such patients. Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per dose. Polysorbate content: This medicinal product contains 0.02 mg of polysorbate per 0.05 mL dose. Patients with hypersensitivity to polysorbate should not take this medicine. Educational materials: Prescribers should be familiar with the patient guide prepared to ensure awareness of signs and symptoms of intraocular inflammation and endophthalmitis and provide this to the patient/caregiver explaining these events. Interactions: No interaction studies have been performed. However, Vabysmo should not be administered concurrently with other systemic or ocular anti VEGF medicinal products. Fertility, Pregnancy and Lactation: Women of childbearing potential: should use effective contraception during treatment and for at least 3 months following the last intravitreal injection. Pregnancy: there are no or limited amount of data in pregnant women. Vabysmo must be regarded as potentially teratogenic and embryo /foetotoxic and should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus. Breast-feeding: it is unknown whether faricimab is excreted in

Make VABYSMO your first choice

human milk. A risk to the breast fed newborn/infant cannot be excluded. Vabysmo should not be used during breast feeding. Refer to SmPC. Fertility: no effects on reproductive organs or fertility were observed in a 6 month cynomolgus monkey study. Effects on ability to drive and use machines: Temporary visual disturbances may occur following Vabysmo intravitreal injection and the associated eye examination. Patients should not drive or use machines until visual function has recovered sufficiently. Undesirable Effects: The most frequently reported adverse reactions were cataract (10%), conjunctival haemorrhage (7%), vitreous detachment (4%), IOP increased (4%), vitreous floaters (4%), eye pain (3%) and retinal pigment epithelial tear (nAMD only) (3%). The most serious adverse reactions were uveitis (0.5%), endophthalmitis (0.4%), vitritis (0.4%), retinal tear (0.2%), rhegmatogenous retinal detachment (0.1%) and traumatic cataract (< 0.1%). All grades: Common (≥1/100 to <1/10): cataract, conjunctival haemorrhage, vitreous detachment, increased intraocular pressure, vitreous floaters, retinal pigment epithelial tear (nAMD only), eye pain. Uncommon (≥ 1/1,000 to < 1/100): corneal abrasion, eye irritation, increased lacrimation, blurred vision, eye pruritus, ocular discomfort, ocular hyperaemia, iritis, reduced visual acuity, uveitis, endophthalmitis, sensation of foreign body, vitreous haemorrhage, vitritis, iridocyclitis, conjunctival hyperaemia, procedural pain, retinal tear, rhegmatogenous retinal detachment. Rare (≥ 1/10,000 to < 1/1,000): transiently reduced visual acuity, traumatic cataract. Not known (frequency cannot be estimated from the available data): retinal vasculitis, retinal occlusive vasculitis. Refer to SmPC for full listings of adverse events. Refer to SmPC section 4.8 for instructions on reporting of suspected adverse events. Legal Category: Product subject to prescription which may not be renewed (A). Presentation(s) and Marketing Authorisation Number(s): Vial (120mg/mL) EU/1/22/1683/001 pack size of one vial and one needle; PFS (120mg/mL) EU/1/22/1683/002 pack size of one injection filter needle, co packed with one pre filled syringe. Marketing Authorisation Holder: Roche Registration GmbH, Emil Barell Strasse 1, 79639 Grenzach Wyhlen, Germany. Vabysmo® is a registered trademark. Further information is available from Roche Products (Ireland) Limited, 3004 Lake Drive, Citywest, Naas Road, Dublin 24. Telephone: (01) 4690700. Date of API Preparation: July 2025.

human milk. A risk to the breast fed newborn/infant cannot be excluded. Vabysmo should not be used during breast feeding. Refer to SmPC. Fertility: no effects on reproductive organs or fertility were observed in a 6 month cynomolgus monkey study. Effects on ability to drive and use machines: Temporary visual disturbances may occur following Vabysmo intravitreal injection and the associated eye examination. Patients should not drive or use machines until visual function has recovered sufficiently. Undesirable Effects: The most frequently reported adverse reactions were cataract (10%), conjunctival haemorrhage (7%), vitreous detachment (4%), IOP increased (4%), vitreous floaters (4%), eye pain (3%) and retinal pigment epithelial tear (nAMD only) (3%). The most serious adverse reactions were uveitis (0.5%), endophthalmitis (0.4%), vitritis (0.4%), retinal tear (0.2%), rhegmatogenous retinal detachment (0.1%) and traumatic cataract (< 0.1%). All grades: Common (≥1/100 to <1/10): cataract, conjunctival haemorrhage, vitreous detachment, increased intraocular pressure, vitreous floaters, retinal pigment epithelial tear (nAMD only), eye pain. Uncommon (≥ 1/1,000 to < 1/100): corneal abrasion, eye irritation, increased lacrimation, blurred vision, eye pruritus, ocular discomfort, ocular hyperaemia, iritis, reduced visual acuity, uveitis, endophthalmitis, sensation of foreign body, vitreous haemorrhage, vitritis, iridocyclitis, conjunctival hyperaemia, procedural pain, retinal tear, rhegmatogenous retinal detachment. Rare (≥ 1/10,000 to < 1/1,000): transiently reduced visual acuity, traumatic cataract. Not known (frequency cannot be estimated from the available data): retinal vasculitis, retinal occlusive vasculitis. Refer to SmPC for full listings of adverse events. Refer to SmPC section 4.8 for instructions on reporting of suspected adverse events. Legal Category: Product subject to prescription which may not be renewed (A). Presentation(s) and Marketing Authorisation Number(s): Vial (120mg/mL) EU/1/22/1683/001 pack size of one vial and one needle; PFS (120mg/mL) EU/1/22/1683/002 pack size of one injection filter needle, co packed with one pre filled syringe. Marketing Authorisation Holder: Roche Registration GmbH, Emil Barell Strasse 1, 79639 Grenzach Wyhlen, Germany. Vabysmo® is a registered trademark. Further information is available from Roche Products (Ireland) Limited, 3004 Lake Drive, Citywest, Naas Road, Dublin 24. Telephone: (01) 4690700. Date of API Preparation: July 2025.

▼ 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.

▼ 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.

In the event of a suspected adverse reaction, please report it to: The Drug Surveillance Centre Roche Products (Ireland) Limited Telephone: (01) 4690700

Email: ireland.drug_surveillance_centre@roche.com

In the event of a suspected adverse reaction, please report it to: The Drug Surveillance Centre Roche Products (Ireland) Limited Telephone: (01) 4690700

Alternatively, suspected adverse reactions should be reported to:

HPRA Pharmacovigilance

Email: ireland.drug_surveillance_centre@roche.com

Website: www.hpra.ie

Alternatively, suspected adverse reactions should be reported to: HPRA Pharmacovigilance Website: www.hpra.ie

Vabysmo® Summary of Product Characteristics [SmPC] is available on www. medicines.ie. M IE 00002187 basedonVabysmo120mg/mLsolutionforinjection and120mg/mLsolutionforinjectioninpre-filledsyringeSmPCdated08May2025

Vabysmo® Summary of Product Characteristics [SmPC] is available on www. medicines.ie. M IE 00002187 basedonVabysmo120mg/mLsolutionforinjection and120mg/mLsolutionforinjectioninpre-filledsyringeSmPCdated08May2025

DR FAISAL I ALMOHAILEB and PROF CAREL LE ROUX, Diabetes Complications Research Centre, University College Dublin

Obesity medication – a long-term management strategy focusing on sustained health improvements

How obesity management has shifted toward long-term health outcomes instead of merely achieving short-term weight loss

In the late 19th Century, obesity was largely dismissed as a mere spectacle rather than a genuine medical concern. Figures like Miss Conley, infamously labelled the ‘fattest woman in the world’, and Daniel Lambert, who weighed an astonishing 335 kilograms at his death in 1809, were objects of public curiosity rather than being considered as patients with a severe form of a common disease. Their extreme cases captivated the public’s imagination, yet they were exploited for entertainment rather than managed medically. During this period, the prevailing view was that obesity was a visible manifestation of gluttony and sloth due to a lack of self-control. Obesity was thus considered a personal failure rather than a disease.

The history of obesity as a chronic disease

In 1904, Dr Leonard Williams suggested that obesity might not solely result from overeating and sedentary behaviour, but could also be linked to metabolic imbalances. This revolutionary idea challenged the simplistic view that weight gain was entirely within an individual’s control. Williams recognised that the habit of overeating often formed in youth, during periods of high physical activity, and these habits could persist into adulthood, even as physical activity levels decreased. He also noted that drinking fluids with meals could increase appetite and accelerate the passage of food through the stomach, leading to greater food consumption. Williams emphasised the importance of chewing food until it becomes fluid and tasteless as a natural method to reduce food intake. His approach to treating obesity focused on dietary modifications and increased physical activity, laying the groundwork for more structured interventions in the future.

In 1902, W M Bayliss and E H Starling published their discovery of secretin, a hormone released into the bloodstream by the small intestine when acidic stomach contents enter it. This hormone stimulates the secretion of digestive juices from the pancreas needed for food breakdown. This showed that pancreatic regulation involves the nervous system and chemical signals, allowing Bayliss and Starling to speculate that organs can communicate and coordinate their activities through blood-borne chemical messengers; a concept now fundamental to our understanding of endocrinology and human biology.

In 1958, Dr Daniel Cappon argued that obesity should not be defined solely by body weight, but by the pathological accumulation of adipose tissue. He emphasised that obesity was not just about how much

someone weighed, but about the distribution and function of fat within the body. This perspective highlighted the inadequacy of using simple bodyweight measurements to define obesity.

In 1994, leptin was discovered, and in 1999, ghrelin was also shown to regulate hunger and fat storage. Leptin, produced by adipose tissue, signals the brain to reduce appetite when fat stores are sufficient, while ghrelin, made in the gastrointestinal tract, stimulates hunger. These discoveries were pivotal in shifting the understanding of obesity from a matter of willpower to a complex endocrine disorder, and a turning point that began to focus on the intricate systems that regulate metabolism and body weight. It became clear that obesity was not simply a result of overeating, but involved a complex interplay of genetic, hormonal, and environmental factors. This realisation laid the groundwork for a more sophisticated approach to treating obesity; one that considered the underlying biological processes driving weight gain.

The birth of statins

Another disease that caused high rates of cardiovascular death, dyslipidaemia, was managed primarily through diet and exercise. However, in 1985, the work of Michael Brown and Joseph Goldstein was awarded the Nobel Prize for discovering the low-density lipoprotein receptor and the HMG-CoA reductase pathway, which explained how cholesterol is synthesised and regulated in the liver. Their research led to the development of statins, a class of drugs that inhibit the HMG-CoA reductase enzyme in the liver, lowering LDL (low-density lipoprotein) cholesterol levels and reducing the risk of cardiovascular death. Statins quickly became the gold standard for managing dyslipidaemia and preventing death, transforming the treatment landscape. The introduction of statins was a watershed moment, as it provided a highly effective pharmacological tool for managing a condition previously unsuccessfully treated with diet and exercise.

Despite their effectiveness, statins also highlighted the challenges of long-term therapy for chronic diseases. By the late 1990s, it became clear that while statins were highly effective in reducing cholesterol levels and preventing cardiovascular events, patient adherence was a significant issue. Recognising dyslipidaemia as a disease catalysed effective management. This shift paved the way for innovative strategies addressing the root causes of poor adherence. By integrating patient-centred approaches and leveraging technology, we have developed personalised treatment plans and support systems that enhance

patient engagement and adherence – resulting in patients living longer and with a better quality-of-life. This lesson is now relevant when treating obesity, where longterm adherence to therapy is equally critical for achieving sustained health benefits.

Pharmacological

management of obesity

The story of how the treatment of dyslipidaemia was transformed is repeated for obesity treatment with glucagon-like peptide (GLP) receptor agonists. In the 1980s, the role of GLP-1 in glucose metabolism was discovered, particularly its ability to stimulate insulin secretion, inhibit glucagon release, and slow gastric emptying –fundamental mechanisms for managing type 2 diabetes and obesity. However, the native GLP-1 peptide was rapidly degraded in the body, necessitating the development of long-acting analogues. In 2004, liraglutide was discovered as a longer-acting GLP1 receptor agonist, allowing for once-daily dosing. Approved by the US Food and Drug Administration (FDA) in 2009 for type 2 diabetes, and later in 2014 for obesity, liraglutide significantly improved glycaemic control and promoted weight loss, marking a significant advance in obesity treatment.

Building on liraglutide’s success, semaglutide was developed as a once-weekly GLP-1 receptor agonist, offering greater convenience and efficacy. Approved in 2017 for diabetes and in 2019 for obesity, semaglutide enabled 15 per cent weight loss, which was unprecedented for obesity pharmacotherapies. The next leap came with tirzepatide, a dual GIP (gastric inhibitory polypeptide, also known as a glucose-dependent insulinotropic polypeptide), and GLP-1 receptor agonist, pushing weight loss to over 20 per cent. These drugs also significantly improved obesity-related complications such as type 2 diabetes, hypertension, and dyslipidaemia. The turning point was in 2023, when, for the first time ever, a randomised control trial confirmed that treating the disease of obesity with semaglutide resulted in fewer cardiac deaths.

However, as with the introduction of statins, the widespread adoption of GLP-1 therapies faced significant hurdles. Currently, adherence to these medications remains a challenge. The high cost of GLP-1 analogues also posed a substantial barrier to long-term use. Additionally, gastrointestinal side-effects such as nausea and vomiting, while generally mild, especially during the initial phase of treatment, contributed to the discontinuation of therapy for some patients. Most importantly, neither patients nor doctors thought of obesity as a biological disease, and hence, taking

lifelong medication made little sense to them. This was problematic because the full benefits of GLP-1 therapy only manifest with long-term usage. Early discontinuation prevents many patients from realising these long-term health improvements. This mirrored the challenges seen with statins, where the benefits of continuous use were clear, but patient adherence was the Achilles’ heel.

A complex and chronic disease

The evolution of obesity treatment reflects a broader shift in understanding the disease as complex and chronic, requiring long-term management. Treating obesity as a biological disease, much like dyslipidaemia, offers significant opportunities for improving patient outcomes. Just as statins became a lifelong therapy for those at risk of cardiovascular disease, GLP-1 analogues and other emerging obesity treatments will have to become integral components of long-term management strategies, focusing on sustained health improvements rather than short-term weight loss. This approach requires a shift in how clinicians and patients view obesity. The goal must move beyond short-term weight loss to achieving health gain, sustained improvements in overall health metrics such as blood pressure, glucose levels, lipid profiles, and, most importantly, obesity complications prevention. Treating obesity as a chronic disease necessitates lifelong management strategies akin to the treatment of hypertension or diabetes. It also means that healthcare systems must adapt, ensuring that these treatments are accessible and that patients receive the ongoing support they need to adhere to long-term therapy. The understanding of obesity has changed from lifestyle choices to recognising it as a biological disease. This marks a significant milestone in medical science, opening doors to more effective and compassionate patient care. The evolution from essential dietary advice to advanced hormonal therapies highlights the tremendous strides in treating obesity. This progress underscores the critical need for ongoing research, robust patient education, and the development of comprehensive, accessible treatment strategies to maximise the benefits of these advancements.

Conclusion

The journey of GLP-1 receptor agonists –from their initial research stages to their prominent role in managing obesity – mirrors the broader evolution in chronic disease treatment. By acknowledging obesity as a biological disease that demands continuous management rather than a onetime cure, the focus has shifted toward long-term health outcomes instead of merely achieving short-term weight loss. This approach aligns obesity management with the treatment models of other chronic diseases, such as asthma, hypertension, and diabetes.

Obesity is thus no more or less unique than any other chronic disease and all we need to do is put it in the same box and manage it the same way we do with other chronic diseases.

References available on request

DR HANNAH FORDE, Consultant Endocrinologist, Beaumont Hospital, Dublin

The evolution of technology in the management of type 1 diabetes

Technological advances are expected in the next few years for the management of diabetes, with improvements in continuous glucose monitoring and more available choices of systems that automate insulin delivery

Type 1 diabetes (T1D) is a chronic autoimmune disease characterised by progressive destruction of the pancreatic beta cells causing insulin deficiency and resultant hyperglycaemia.1 T1D accounts for approximately 5-10 per cent of all diabetes and there are between 20,000 to 30,000 people currently living in Ireland with this disease.2,3 There is currently no cure for T1D and the mainstay of treatment is physiological insulin replacement via multiple daily injections (MDI) of insulin or continuous subcutaneous insulin infusion (CSII) therapy. The aim of care and management is to support the person with diabetes to live a long and healthy life by achieving glycaemic targets, effectively managing cardiovascular risk factors, minimising hypoglycaemia, and maintaining quality-of-life.

People with T1D must learn to self-adjust their insulin doses in order to achieve glycaemic targets and minimise the risk of microvascular and macrovascular complications. The landmark Diabetes Control and Complications Trial (DCCT) demonstrated that intensive insulin therapy reduced the risk of development and progression of diabetic retinopathy, neuropathy, and nephropathy compared with conventional treatment in people with T1D.4 Data from the Epidemiology of Diabetes Interventions and Complications (EDIC) follow-up observational study confirmed sustained benefits of early intensive glycaemic control for diabetes-related microvascular complications and a lower incidence of cardiovascular disease.5 The intervention group in the DCCT maintained a mean haemoglobin (Hb)A1c of ~7 per cent (53mmol/ mol), and this study forms the basis for current glycaemic target recommendations for most people with T1D.4

One of the greatest challenges in the management of T1D is balancing tight glycaemic control with the risk of hypoglycaemia and indeed there was a two- to three-fold increase in the rate of severe hypoglycaemia in the intervention group in DCCT.4 Reported rates of severe hypoglycaemia in unselected cohorts of people with T1D vary from 0.3-3 events per year, whilst non-severe hypoglycaemic events tend to occur twice per week.6 Structured education courses (eg, DAFNE) have been shown to reduce the incidence of severe hypoglycaemia and newer diabetes technologies can also help with many aspects of daily diabetes management including hypoglycaemia prevention.7

CGM: The evidence

Continuous glucose monitoring (CGM) devices have proven to be effective at improving glycaemic control while also reducing hypoglycaemia.8,9 These devices consist of

three components. A sensor containing a glucose oxidase electrode is inserted under the skin and reacts with glucose in the interstitial fluid to generate hydrogen peroxide and an electron signal.10 A transmitting device sends the electric signal to a receiving device (eg, an insulin pump, a mobile phone, a handheld receiver), which displays the glucose reading, the direction the glucose is travelling, and retrospective glucose data over the preceding number of hours.

These devices have multiple benefits, most obviously the instant availability of 24 hours of sensor glucose data without any additional fingerstick glucose measurements required of the person with diabetes. In addition, trend arrows are useful for the person with diabetes when deciding on how much quick-acting insulin to deliver. Alerts on sensors can warn the person with diabetes about impending hypo- or hyperglycaemia, allowing the person time to take action and prevent the event. In randomised controlled trials, CGM has been associated with a HbA1c reduction of approximately 0.5 per cent compared with self-monitoring of blood glucose.8,11 In 2021, the American Diabetes Association and European Association for the Study of Diabetes published a joint consensus statement recommending CGM for all people with T1D.12 This was mirrored in the updated UK National Institute for Health and Care Excellence (NICE) guidelines published in 2022, and in the recently published guidelines for the management of T1D in Ireland.3,13

As CGM is now the standard of care in T1D, there are numerous agreed-upon CGM metrics which provide guidance for clinicians and individuals with diabetes in using, interpreting, and reporting CGM data in clinical practice. The most commonly used metric to guide diabetes manage-

ment is time in target range (sensor glucose between 3.9-10mmol/l), and the international consensus recommendation is that most people with T1D and type 2 diabetes should aim to spend >70 per cent of their time with their sensor glucose values in the target range.14

Pump therapy

The first use of CSII with an insulin pump was described in 1978.15 However, rapid uptake of pump therapy did not occur until publication of the DCCT, as individuals on CSII had better glycaemic outcomes compared to those treated with MDI.4 Insulin pumps are small computerised devices that continuously deliver rapid-acting insulin to the person with diabetes via a subcutaneous cannula. Historically in Ireland, uptake of pump therapy has been far lower than that of our European counterparts. However, recent data indicates that the number of pump users in Ireland is increasing, and approximately 15 per cent of people with T1D in Ireland are using insulin pump therapy.16 The main advantages of traditional pump therapy were the ability to vary basal insulin delivery and the ease of administering frequent boluses throughout the day. Although the evidence-base for pump therapy suggests their use is associated with reduced hypoglycaemia and improved quality-of-life, pump use only modestly improves glycaemic control.17-19

a control algorithm, which automatically adjusts basal insulin delivery every few minutes based on sensor glucose values. Although there are differences between the various algorithms contained within the systems, typically, if sensor glucose is dropping or predicted to drop below the glucose target, the system will reduce basal insulin delivery. If sensor glucose is rising or predicted to rise above the glucose target, the system will increase insulin delivery. Most systems will deliver auto-corrections to manage hyperglycaemia and will halt basal insulin delivery if sensor glucose is predicted to enter the hypoglycaemic range. HCL systems do not fully automate diabetes management and users must continue to deliver boluses for their meals. All of the systems have an override feature, which will make the algorithm less aggressive, and this is commonly enabled by the person with diabetes to manage insulin delivery around exercise/activity. There is now ample randomised control trial (RCT) data, as well as real world evidence, demonstrating the benefits of HCL therapy for people with T1D.

The ADAPT study was a multi-centre RCT which compared advanced HCL therapy with the Medtronic 780G system with intermittently scanned CGM and MDI in 82 adults with T1D who had HbA1c levels above 8.0 per cent.20 In this study, the mean HbA1c of the participants in the intervention group decreased from 9.0 per cent at baseline to 7.3 per cent after three months of HCL.20 This improvement in HbA1c was sustained at six months. Participants in the control group had minimal improvement in their mean HbA1c levels, which reduced from 9.1 per cent at baseline to 8.9 per cent at six months.20

Studies comparing HCL therapy with sensor augmented pump therapy in young children and older adults with T1D have also yielded positive results, with HCL use being associated with higher time in range compared to sensor augmented pump therapy.21,22 In 2021, the NHS in England announced funding for a real-world pilot of HCL systems for people with T1D who had suboptimal HbA1c levels (>8.5 per cent) despite the use of CGM and traditional pump therapy. Hundreds of individuals from adult diabetes centres in England were invited to participate in this pilot and offered any of the commercially available closed loop systems at the time. Glycaemic and psychosocial outcomes from 520 people with diabetes who were included in the pilot were assessed after six months of HCL therapy.23 The use of HCL was associated with significant improvement in glycaemic metrics with a mean reduction in HbA1c of

Over the last 10 years or so, insulin pump technology has significantly progressed and most pump users are now using hybrid closed loop (HCL) therapy. HCL therapy (also called automated insulin delivery systems or the artificial pancreas) is the most advanced form of insulin delivery available. It involves the augmentation of pump therapy with integrated real-time CGM and  Continued on p26

Credit: istock/rudi_suardi

TOUJ0O® From the start,1 there to help your patients on their basal insulin journey 1 insulin glargine 3D0U/mL

• Help your patients find balance between HbA le reduction and hypoglycaemic risk1 -7

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Toujeo® DoubleStar ™ prefilled pen is recommended for patients requiring at least 20 units per day.1

t Toujeo® is available in easy-to-use pens,1.s.9 to be administered once daily at any time of the day, preferably at the same time every day.1 When needed, patients can administer Toujeo� up to 3 hours before or after their usual time of administration. Flexible dosing time was evaluated in two randomised, open-label clinical studies, in patients with T2DM.

prescribing Information: Toujeo®(insulin qlargine 300 uni ts/ml) Please refer to Summary of Product Characteristics (SmPC) before prescribing. Presentation: Toujeo SoloStar and DoubleStar pre-filled pens. Each ml contains 300 units of insulin glargine. SoloStar pen contains 1.5ml (450 units) of solution for injection. DoubleStar pen contains 3ml (900 units) of solution for injection. Indication: Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years. Dosage and Administration: Toujeo is administered subcutaneously, by injection into the abdominal wall, the deltoid or the thigh, once daily, at any time of the day preferably at the same time every day. Injection sites must be rotated within a given injection area from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis. The dose regimen (dose and timing) should be adjusted according to individual response. Do not administer intravenously. In type 1 diabetes mellitus, Toujeo must be combined with short-/rapidacting insulin to cover mealtime insulin requirements. In patients with type 2 diabetes mellitus, recommended daily starting dose is 0.2 units/kg followed by individual dose adjustments. Toujeo can also be given together with other anti-hyperglycaemic medicinal products. Switch between insulin glarqine 100 units/ml and Tou;eo: Insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not directly interchangeable. When switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit-to-unit basis, but a higher Toujeo dose (approximately 10-18%) may be needed to achieve target ranges for plasma glucose levels. When switching from Toujeo to insulin glargine 100 units/ml, the dose should be reduced (approximately by 20%). Switching from other basal insulins � A change of dose and/or timing of the basal insulin and concomitant anti-hyperglycaemic treatment may be required. Dose adjustments may also be required if the patient's weight or lifestyle changes, the timing of insulin dose is changed, or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia. Toujeo must not be mixed or diluted with any other insulin or other medicinal products. Close metabolic monitoring is recommended during a switch and in the initial weeks thereafter. SoloStar 1-80 units per single injection in steps of 1 unit and DoubleStar 2-160 units in steps of 2 units. When changing from Toujeo SoloStar to Toujeo DoubleStar, if the patient's previous dose was an odd number then the dose must be increased or decreased by 1 unit. Toujeo DoubleStar prefilled pen is recommended for patients requiring at least 20 units per day. Special Populations: Insulin requirements may be diminished in the elderly or patients with renal or hepatic impairment. Paediatdc: When switching basal insulin to Toujeo, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to minimise the risk of hypoglycaemia. The safety and efficacy of Toujeo in children and adolescents below 6 years of age have not been established. Contraindications: Hypersensitivity to insulin glargine or any excipients. Precautions and Warnings: Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Toujeo is not the insulin of choice for treatment of diabetic ketoacidosis. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood

Intended for Healthcare Professionals in the Republic of Ireland only.

glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered. Hypoglycaemia: In case of insufficient glucose control or a tendency to hyper/hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Particular caution should be exercised, and intensified blood glucose monitoring is advisable for patients in whom hypoglycaemic episodes might be of clinical relevance and in those where dose adjustments may be required. Warning signs of hypoglycaemia may be changed, less pronounced or absent in certain risk groups, potentially resulting in severe hypoglycaemia and loss of consciousness. Risk groups include patients in whom glycaemic control is markedly improved, hypoglycaemia develops gradually, an autonomic neuropathy is present, or who are elderly. The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia. lntercurrent illness: Requires intensified metabolic monitoring and often it is necessary to adjust the insulin dose. Insulin antibodies: administration may cause insulin antibodies to form. Use with pioglitazone: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Medication errors: Insulin labels must always be checked before each injection to avoid errors between Toujeo and other insulins. Patients must be instructed to never use a syringe to remove Toujeo from the SoloStar or DoubleStar prefilled pen, A new sterile needle must be attached before each injection. Needles must not be re-used. Pregnancy and lactation: There are no data from exposed pregnancies in controlled clinical trials. However there is a large amount of data on use of insulin glargine 100 units/ml in pregnant women indicating no specific adverse effects on pregnancy and no specific malformative nor feta/neonatal toxicity. The use of Toujeo may be considered during pregnancy, if clinically needed. Careful monitoring of glucose control is essential. It is unknown if insulin glargine is excreted in breast milk. Interactions: Substances that affect glucose metabolism may require adjustment of insulin glargine. Adverse Reactions: Very common· Hypoglycaemia. Prolonged or severe hypoglycaemia may be life-threatening.� Lipohypertrophy injection site reactions, including redness, pain, itching, hives, swelling, or inflammation. Prescribers should consult the SmPC in relation to other adverse reactions. Legal Category: POM. Marketing Authorisation Number: SoloStar 5 pen pack: EU/1/00/133/035; Double5tar 5 pen pack: EU/1/00/133/038. Marketing Authorisation Holder: Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. Further information is available from: Medical Information, Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com. Date of preparation: July 2022

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie; email: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via email to IEPharmacovigilance@sanofi.com

Abbreviations: HbAlc, Hemoglobin A1c; PD, Pharmacodynamics; PK Pharmacokinetics; TlDM. Type 1 Diabetes Mellitus; T2DM, Type 2 Diabetes Mellitus. References: 1. Toujeo', Summary of Product Characteristics 2. Home PD, et al Diabetes Care 2015;38(12):2217-2225. 3. Matsuhisa M, et al Diabetes Obes Metab 2016;18(4):375-383. 4 Danne T. et al. Diabetes Care 2020: 43(7):1512-1519, 5. Riddle MC, et al. Diabetes Care 2014;37:2755-2762. 6. Yki-Jarvinen H, et al Diabetes Care 2014;37:3235-3243. 7. Bolli GB, et al. Diabetes Obes Metab 2015;17:386-394. 8 Singh R, et al. Eur Endocrinol 2018;14:47-51. 9 Pohlmeier H, et al. J Diabetes Sci Technol 2017;11;263-269. MA T IE-2500032 (v2 .OJ April 2025

 Continued from p24

1.7 per cent and a mean increase in time in range of 27.6 per cent.23 Use of HCL was also associated with a reduction in diabetes distress and an improvement in awareness of hypoglycaemia.23

In the past, people with very high HbA1c levels, on MDI, would never have been considered suitable candidates for pump therapy due to concerns around adherence with glucose monitoring, performing set changes, engaging with the clinical team, etc. However, it is likely that this cohort will derive the most benefit from HCL systems. Indeed, a recent observational study investigating the impact of initiating closed loop therapy in high-risk individuals with diabetes who had a mean HbA1c of 10.5 per cent at baseline, demonstrated substantial and sustained improvements in both glycaemic control and quality-of-life after 12 months of HCL therapy.24

In 2023, NICE criteria for HCL eligibility was updated and now all children with T1D under 18 years of age are eligible for HCL therapy. Adults with T1D are eligible for HCL therapy if, despite the use of either CGM or open-loop pump therapy, they have a HbA1c above 7.5 per cent, are experiencing disabling hypoglycaemia, or trying for pregnancy.25 In Ireland, there are no specific eligibility criteria for HCL in T1D. In theory, anyone with T1D could access HCL; however, significant geographical variation exists in terms of the number of adult diabetes services providing pump therapy.

References

1. Katsarou A, Gudbjörnsdottir S, Rawshani A, et al. Type 1 diabetes mellitus. Nat Rev Dis Primers. 2017;3:17016

2. Daneman D. Type 1 diabetes. Lancet 2006;367(9513):847-58

3. Department of Health. Type 1 diabetes mellitus in adults version 2: National Clinical Guideline No 17. Dublin: DoH; 2024. Available at: www.gov. ie/en/collection/2269a-type-1-diabetes-mellitus-in-adults-version-2/

4. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. New Eng J Med. 1993;329(14):977-86

5. The Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular outcomes in type 1 diabetes: The DCCT/EDIC study 30-year follow-up. Diabetes Care. 2016;39:686-693

6. Pedersen-Bjergaard U, Thorsteinsson B. Reporting severe hypoglycaemia in type 1 diabetes: Facts and pitfalls. Curr Diab Rep. 2017;17(12):131

7. Hopkins D, Lawrence IA, Mansell P, Thompson G, Amiel S, Campbell M, et al. Improved biomedical and psychological outcomes 1 year after structured education in flexible insulin therapy for people with type 1 diabetes: The UK DAFNE experience. Diabetes Care. 2012;35(8):1638-42

8. Beck RW, Riddlesworth T, Ruedy K, et al. Effect of continuous glucose monitoring on glycaemic control in adults with type 1 diabetes using insulin injections: The DIAMOND randomised clinical trial. JAMA. 2017;317(4):371-8

Available technology

There are currently three commercially available HCL systems in Ireland; the Medtronic 780G system with Smartguard algorithm, the Tandem T:slim X2 pump with Control-IQ algorithm, and the Ypsomed pump with mylife loop algorithm. Unfortunately, Omnipod 5, which is currently the only tubeless automated insulin delivery system, is not available in Ireland at present. There are several factors that need to be considered by the person with diabetes when choosing the right HCL for themselves.

There are differences in the licensing for the systems, which may need to be taken into account for young people with diabetes or those planning pregnancy. Some people may have a preference for a particular pump or CGM device which may dictate their choice of HCL system. There are also subtle differences in the algorithms, which may have an impact on which system the person with diabetes deems most suitable for their needs. Fortunately, glycaemic outcomes from each of the three systems are very similar. Data from thousands of users of these systems have demonstrated that the mean time in range associated with these systems is 71.5-72.6 per cent, with minimal hypoglycaemia.26,27,28 Glycaemic outcomes with HCL can be further improved by optimising algorithm settings, pre-meal bolusing, accurate carbohydrate counting, and appropriate management of hypoglycaemia, set failures, and activity.

With HCL therapy, as with MDI regimes,

9. Heinemann L, Freckmann G, Ehrmann D, et al. Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): A multicentre, randomised controlled trial. Lancet. 2018;391(10128):1367-77

10. Soni A, Wright N, Agwu JC, et al. Fifteen-minute consultation: Practical use of continuous glucose monitoring. Archives of Disease in Childhood-Education and Practice. 2022;107(3):188-93

11. Leelarathna L, Evans ML, Neupane S, et al. Intermittently scanned continuous glucose monitoring for type 1 diabetes. New Eng J of Med. 2022;387(16):1477-87

12. Holt RI, DeVries JH, Hess-Fischl A, Hirsch IB, Kirkman MS, Klupa T, et al. The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2021;44(11):2589-625

13. National Institute for Health and Care Excellence. Type 1 diabetes in adults: Diagnosis and management. NICE guideline [NG17]. NICE; 2022. Available at: www.nice.org.uk/guidance/NG17

14. Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: Recommendations from the international consensus on time in range. Diabetes Care. 2019;42(8):1593-603

15. Pickup JC, Keen H, Parsons JA, Alberti KG. Continuous subcutaneous insulin infusion: An approach to achieving normoglycaemia. Br Med J. 1978;1(6107):204-7

16. Blood Sugar Trampoline. Insulin pump use in Ireland. 2023. Available at: www.bloodsugartrampoline.com/blog/2023/8/16/insulin-pump-use-

optimal bolusing behaviours is associated with higher time in range; ie, bolusing for all meals in advance of the meals. An ancillary study from an RCT evaluating HCL in children with T1D demonstrated time in range of 80 per cent when timing of boluses were optimum.29 However, time in range was still 59 per cent when the children had two or more suboptimal boluses per day. Furthermore, when children missed two or more boluses per day, they were still able to achieve a time in range of 62 per cent, indicating that the closed loop system in this study compensated remarkably well for missed meal boluses.29

Historically, in many diabetes services, completion of a structured education course (eg, DAFNE) was a pre-requisite for commencement on insulin pump therapy. However, HCL therapy can somewhat alleviate hyperglycaemia resulting from an underestimation of carbohydrate intake by increasing basal insulin delivery and administering autocorrections. This was demonstrated in the FLEX study, which evaluated adolescents using the Medtronic 780G system and compared accurate carbohydrate counting with simplified meal announcements, ie, inputting fixed carbohydrate amounts into the bolus advisor for each meal.30 After 12 months of follow-up, there was no significant difference in HbA1c levels between the two groups, although time in range was higher in those who were accurately carbohydrate counting.30

The importance of completing set changes every two-to-three days cannot be reiterated strongly enough to people using HCL

in-ireland

17. Misso ML, Egberts KJ, Page M, et al. Cochrane review: Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2010;5(4):1726-867

18. REPOSE Study Group. Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: Cluster randomised trial (REPOSE). BMJ 2017;356:j1285

19. Pickup JC, Sutton AJ. Severe hypoglycaemia and glycaemic control in type 1 diabetes: Meta‐analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diabetic Medicine. 2008;25(7):765-74

20. Choudhary P, Kolassa R, Keuthage W, et al. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): A randomised controlled study. Lancet Diabetes Endocrinol. 2022;10(10):720-31

21. Ware J, Allen JM, Boughton CK, et al. Randomised trial of closed-loop control in very young children with type 1 diabetes. New Eng J Med. 2022;386(3):209-19

22. McAuley SA, Trawley S, Vogrin S, et al. Closedloop insulin delivery versus sensor-augmented pump therapy in older adults with type 1 diabetes (ORACL): A randomised, crossover trial. Diabetes Care. 2022;45(2):381-90

23. Crabtree TS, Griffin TP, Yap YW, et al. Hybrid closed-loop therapy in adults with type 1 diabetes and above-target HbA1c: A real-world observational study. Diabetes Care. 2023;46(10):1831-8

24. Michaels VR, Boucsein A, Watson AS, et al. Glucose and psychosocial outcomes 12 months

systems. Any reduction in insulin absorption because of a problem at the insertion site or an issue with the infusion set can affect the algorithm as the system operates based on the assumption that the person is receiving the insulin being delivered by the pump. The absence of long-acting basal insulin in pump users contributes to the rapid development of diabetic ketoacidosis in the event of an infusion set failure. With HCL therapy, it is very unusual to have glucose readings above 15mmol/l for over two hours. If this occurs, the person with diabetes should give the pump one opportunity to correct the hyperglycaemia, and if this does not result in an improvement in glucose levels, infusion site failure should be considered and a complete set change performed.

Conclusion

Over the last decade considerable progress has been made in diabetes care with advancements in automated insulin delivery systems. HCL technology may be useful in a wide array of patient populations including older adults, those with cystic fibrosis-related diabetes, or chronic kidney disease, and could also address unmet needs in inpatient diabetes care. The technology continues to evolve and more advanced systems with more aggressive algorithms and no requirement for food boluses are in development. The future looks bright for T1D care, but increasing access and ensuring equitable access to these technologies is likely to challenge diabetes services going forward.

following transition from multiple daily injections to advanced hybrid closed loop in youth with type 1 diabetes and suboptimal glycaemia. Diabetes Technol Ther. 2024;26(1):40-8

25. National Institute for Health and Care Excellence. Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes. Technology appraisal guidance. TA943. NICE; 2023. Available at: www.nice.org.uk/guidance/ta943/

26. Choudhary P, Arrieta A, van den Heuvel T, Castañeda J, Smaniotto V, Cohen O. Celebrating the data from 100,000 real-world users of the MiniMed 780G system in Europe, Middle East, and Africa collected over three years: From data to clinical evidence. Diabetes Technol Ther. 2024;26(S3):32-7

27. Messer LH, Breton MD. Therapy settings associated with optimal outcomes for t:slim X2 with control-IQ technology in real-world clinical care. Diabetes Technol Ther. 2023;25(12):877-82

28. Alwan H, Wilinska ME, Ruan Y, et al. Real-world evidence analysis of a hybrid closed-loop system. J Diabetes Sci Technol. Published online July 8, 2023

29. Coutant R, Bismuth E, Bonnemaison E, et al. Hybrid closed loop overcomes the impact of missed or suboptimal meal boluses on glucose control in children with type 1 diabetes compared to sensor-augmented pump therapy. Diabetes Technol Ther. 2023;25(6):395-403

30. Petrovski G, Campbell J, Pasha M, et al. Twelvemonth follow-up from a randomised controlled trial of simplified meal announcement versus precise carbohydrate counting in adolescents with type 1 diabetes using the MiniMed 780G Advanced Hybrid Closed-Loop System. Diabetes Technol Ther. 2024;26(S3):76-83

PRISCILLA LYNCH

Predicting kidney risk and survival in diabetes

Scientists reveal how simple blood markers predict risks of kidney disease and death in people with diabetes mellitus

People with diabetes often develop kidney disease without warning, leading to life-threatening complications. Now, researchers have discovered that two simple blood markers, estimated glomerular filtration rate difference (eGFRdiff) and growth differentiation factor-15 (GDF-15), can independently predict who is at an elevated risk of kidney function decline and early death. The findings could help clinicians identify vulnerable patients sooner, paving the way for timely, personalised treatments that slow disease progression, and improve outcomes for millions living with diabetes.

Identifying individuals with diabetes who are at risk of rapid kidney function decline or early death has challenged doctors for decades, with traditional markers like serum creatinine and urinary albumin falling short of accurately predicting these risks.

However, a new observational study, published recently in the Journal of Cachexia, Sarcopenia, and Muscle, offers a promising solution. A team of researchers led by Associate Professor Tomohito Gohda from the Department of Nephrology, Juntendo University Faculty of Medicine, Japan, found that two simple blood markers – eGFRdiff, a measure that reflects differences between cystatin C- and creatinine-based kidney function estimates, and GDF-15, a protein increasingly recognised as a marker of inflammation and frailty –can independently predict kidney disease progression and mortality in people with diabetes.

“Currently, eGFR and urinary albumin, which are com-

MULTIPLE CHOICE QUESTIONS

1

In ectropion

monly used in routine clinical practice, are not sufficient to accurately predict kidney outcomes in individuals with diabetes,” said Dr Gohda.

“The development of novel biomarkers that complement these existing markers may allow for the earlier and more convenient identification of patients at high-risk for kidney disease progression and mortality.”

The research team analysed data from 638 Japanese adults living with diabetes mellitus. Participants were observed for a period of more than five years, during which 11.8 per cent experienced significant kidney function decline and 6.9 per cent died from various causes. Blood samples were used to calculate eGFRdiff and to determine serum levels of GDF-15.

The analysis revealed a powerful link: Patients with lower eGFRdiff values faced a dramatically higher risk of chronic kidney disease (CKD) progression, while those with elevated GDF-15 levels were at higher risk of increased mortality. Specifically, every 10-unit increase in eGFRdiff reduced the risk of CKD progression by 33 per cent, while higher GDF15 levels were strongly linked to an increased risk of death by 235 per cent.

“eGFRdiff may contribute to early risk stratification in diabetic kidney disease and assist in developing personalised treatment strategies, potentially leading to improved quality-of-life for individuals with diabetes and reduced healthcare costs,” explained Dr Gohda.

Importantly, this research demonstrated that these two markers provide complementary insights. eGFRdiff, which can reflect muscle mass loss and metabolic changes, was

A. The lower lid ‘droops’ away from the eye.

B. The affected eye constantly waters.

C. A stringy white mucoid discharge is characteristic.

D. Eyelid retraction causes the patient to have a ‘staring’ appearance.

E. Plastic surgery may help to correct the problem.

E. Diurnal variation in mood. Question 2

Question 4

When screening for asymptomatic disease

A. The outcome of screening must be judged in terms of restoration of biochemical or other test results to normal.

B. Earlier diagnosis by itself will increase survival rates over a short period.

C. The specificity of a test measures its ability to detect a high proportion of the true cases.

D. The yield is measured solely by the number of cases identified.

E. Population scale screening for asymptomatic diabetes has been proven to be well worthwhile.

In an older patient, clinical features supporting a diagnosis of depression rather than one of dementia include

A. Disturbed sleep-wake cycle with day-night reversal.

B. Clouded consciousness.

C. Abrupt onset.

D. Memory loss equal for recent and remote events.

Question 5 Keratoacanthoma lesions

A. Occur mainly on exposed skin.

B. Rarely exceed 0.5cm in size when fully mature.

C. Develop a keratinised plug in their centre.

D. Take about nine months from start to resolution.

E. Leave no scar on healing.

Characteristic features of rheumatoid arthritis include

A. Morning stiffness.

B. Monoarthropathy.

C. Rheumatoid nodules.

D. Positive test for rheumatoid factor.

E. Erosions seen on radiographs of the hands and feet (within three years of diagnosis).

more strongly associated with kidney disease progression. On the other hand, GDF-15, a stress-responsive cytokine linked to inflammation, better predicted mortality risk. This distinction suggests that using the two markers together could enhance precision in identifying which patients are most vulnerable to serious complications. Future research should focus on identifying modifiable factors that contribute to lower eGFRdiff values and elucidating their clinical implications.

Globally, diabetes is a leading cause of CKD, which can progress to end-stage kidney disease requiring dialysis –a treatment with profound impacts on patients’ lives and high costs for healthcare systems. Early detection of kidney risk using eGFRdiff and GDF-15 could enable clinicians to tailor interventions sooner, slowing or even preventing disease progression and potentially saving lives.

“Our results suggest that frailty and sarcopaenia, driven by inflammation and metabolic abnormalities, may contribute to CKD progression and mortality in individuals with diabetes mellitus,” concluded Dr Gohda. “eGFRdiff assessment may enhance the identification of high-risk individuals.”

Reference Gohda T, Kamei N, Tanaka M, Furuhashi M, Sato T, Kubota M, et al. Association of difference between eGFR from cystatin C and creatinine and serum GDF-15 with adverse outcomes in diabetes mellitus. J Cachexia Sarcopenia Muscle. 2025 Aug;16(4):e70011

E. TRUE. 70 per cent develop erosions within three years of diagnosis.

D. TRUE. 75 per cent have a positive test.

C. FALSE. May get these, but in a minority of patients.

B. FALSE. Is normally a polyarthritis.

A. TRUE. Painful swollen joints and stiffness, especially in the morning, is characteristic.

ANSWER 5

E. FALSE. They leave an ugly scar and as a few lesions may become malignant, the treatment of choice is excision.

D. TRUE. They usually take three months to develop, remain unchanged for three months and then take three months to resolve.

C. TRUE. Which may break down to form a crater.

B. FALSE. They rapidly expand to a diameter of about 1cm.

A. TRUE. Of fair-skinned patients.

ANSWER 4

E. TRUE. More stable on dayto-day basis in dementia.

D. TRUE. Greatest for recent events in dementia.

C. TRUE. Or relatively insidious in depression, whereas insidious, chronic illness progressing over years in dementia.

A. FALSE. This is dementia. Early morning waking is depression.

ANSWER 3

E. FALSE. No clear evidence that prognosis for this group is improved by treatment, therefore little value in finding cases.

D. FALSE. Cases where prognosis is improved as a result of early detection related to the total number of tests performed.

A sensitive test detects a high proportion of the true cases.

C. FALSE. A specific test has few false positives.

B. TRUE. Simply by increasing the time between diagnosis and death.

A. FALSE. In terms of its effect on mortality or illness.

ANSWER 2

is common in older people and those with facial palsies. B. TRUE. As the lower punctum of the tear duct is no longer draining. C. FALSE. This occurs in entropion. D. FALSE. This would suggest hyperthyroidism. E. TRUE. A lubricating ointment may help in the interim.

B. FALSE. Not clouded in either, except in terminal stages of dementia.

Question

Irish Cardiac Society, Annual Scientific Meeting and AGM, Great Southern Hotel, Killarney, Co Kerry, 16-18 October 2025

AI, advocacy, and women’s cardiovascular health on ICS agenda

The upcoming Annual Scientific Meeting of the Irish Cardiac Society will feature distinguished speakers sharing the latest evidence in the field of cardiology

The Irish Cardiac Society (ICS) Annual Scienti c Meeting and AGM is the largest gathering of the Irish cardiology profession each year, attracting hundreds of delegates. e meeting delivers a varied scienti c programme comprising of ex-

pert keynote presentations, showcasing of selected abstracts, training programme updates, and interactive sessions.

e event, which facilitates the meetings of the Irish Atherosclerosis Society, the Irish Nurses Cardiovascular Association and the Irish Clinical Physiologists, is an excellent

networking opportunity for members and all healthcare professionals working in cardiology, who come together to share information and knowledge.

is year’s meeting will take place at the Great Southern Hotel, Killarney, Co Kerry, on 16-18 October. ICS President Prof Brendan McAdam told the Medical Independent: “I’m very much looking forward to welcoming ICS members, faculty, and invited guests to Killarney next month. Our 76th Annual Scienti c Meeting o ers a valuable platform to showcase new and emerging cardiovascular research, alongside keynote presentations from leading international experts.”

He added: “ is year, we’re honoured to welcome Prof Garret FitzGerald, who will deliver the prestigious Stokes Lecture, and Dr Robert Cali , who will speak on the timely topic, ‘Tackling the tsunami of cardiovascular disease in tumultuous times'.” He added that an Honorary Fellowship of the Society will be awarded to 11 recipients.

“Beyond the scienti c programme, the meeting is a wonderful opportunity for colleagues and friends in cardiology to reconnect and engage in what promises to be another informative and enjoyable ICS meeting for all.” e ICS scienti c programme will open on 17 October with a welcome address from Prof McAdam. An update on management of hypertrophic cardiomyopathy will be provided by Dr Carolyn Ho, Brigham and Women’s Hospital, Boston, US. Dr Ho is the author of over 30 peer-reviewed publications. Her research focuses on characterising early phenotypes of sarcomere mutations in inherited cardiomyopathies and developing clinical trials to diminish the progression of hypertrophic cardiomyopathy.

Later in the morning there will be an international session on women and cardiovascular disease featuring speakers Dr Sandra Lewis (American College of Cardiology); Prof Cecilia Linde (European Society of Cardiology); and Prof Andre Ng (British Cardiovascular Society).

e event will also feature the Brian Maurer Young Investigator Award 2025. e Award is aimed at promising early career investigators to encourage and promote quality and original research in cardiology. e award is named in honour of the late Dr Brian Maurer who was President of the ICS from 1988 to 1990 and who, throughout his career, was a strong advocate for research and very supportive of all early career cardiologists.

e Stokes Lecture is the keynote address of the conference. Each year an individual who has made an outstanding contribution to the profession of cardiology and who has Irish connections is invited to present to the membership body.

e title of the 2025 Stokes Lecture, by Dr Garret FitzGerald, is 'Time's arrow: e ageing chronobiome’. Dr FitzGerald, a distinguished physician-scientist based at the University of Pennsylvania, is a graduate of University College Dublin. His research contributed fundamentally to the development of low dose aspirin for cardioprotection and both predicted and elucidated the mechanism by which other nonsteroidal anti-in ammatory drugs can cause a cardiovascular hazard.

On 18 October, Dr Ben Freed, Illinois Chapter, American College of Cardiology, will present on pulmonary hypertension and right ventricular dysfunction. In addition, the latest developments in heart failure treatment will be explored by Prof Mark Petrie, Glasgow Royal In rmary, Scotland. Prof Petrie's research interests include revascularisation in heart failure, interventional heart failure, peripartum cardiomyopathy, and diabetes and cardiovascular disease, among other areas.

e afternoon will also feature a discussion on novel and current issues in cardiology. Topics will include AI and cardiology; advocating for an EU cardiovascular health strategy; and implementation of the national review of cardiac services.

If you suspect ATTR-CM, consider VYNDAQEL ▼ (tafamidis) 61 mg

– the first and only treatment proven to reduce all-cause mortality and frequency of CV-related hospitalisations in patients with wild-type or hereditary ATTR-CM. 1,2

ATTR-CM is an underdiagnosed, overlooked cause of heart failure.3

Once diagnosed, untreated patients have a median survival of ~2–3.5 years 4

You can change that. Timely diagnosis and treatment of ATTR-CM has been predicted to extend mean life expectancy by 5.46 years (wild-type) and 7.76 years (hereditary) compared with delayed diagnosis.5

Help your patients add meaningful new steps to their journey, with proven efficacy, while retaining their quality of life – with VYNDAQEL2,6

Visit www.vyndaqel.ie for more information.

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. Refer to section 4.8 of the SPC for how to report adverse reactions.

Vyndaqel 61 mg soft capsules (tafamidis) Prescribing Information: Before prescribing Vyndaqel please refer to the full Summary of Product Characteristics. Presentation: Vyndaqel 61 mg soft capsules. Each soft capsule contains 61 mg tafamidis. Uses: Vyndaqel is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Dosage: Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. When there is a suspicion in patients presenting with specific medical history or signs of heart failure or cardiomyopathy, etiologic diagnosis must be done by a physician knowledgeable in the management of amyloidosis or cardiomyopathy to confirm ATTR-CM and exclude AL amyloidosis before starting Vyndaqel, using appropriate assessment tools such as: bone scintigraphy and blood/urine assessment, and/or histological assessment by biopsy, and transthyretin (TTR) genotyping to characterise as wild-type or hereditary. The recommended dose is one capsule of Vyndaqel 61 mg (tafamidis) orally once daily. Vyndaqel 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine, tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Vyndaqel should be started as early as possible in the disease course when the clinical benefit on disease progression could be more evident. Conversely, when amyloid-related cardiac damage is more advanced, such as in NYHA Class III, the decision to start or maintain treatment should be taken at the discretion of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. There are limited clinical data in patients with NYHA Class IV. If vomiting occurs after dosing, and the intact Vyndaqel capsule is identified, then an additional dose of Vyndaqel should be administered if possible. If no capsule is identified, then no additional dose is necessary, with resumption of dosing the next day as usual. There are no recommended dosage adjustments for elderly patients or patients with renal or mild and moderate hepatic impairment. Limited data are available in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min). Tafamidis has not been studied in patients with severe hepatic impairment and caution is recommended. There is no relevant use of tafamidis in the paediatric population. Method of Administration: The soft capsules should be swallowed whole and not crushed or cut. Vyndaqel may be taken with or without food. Contra-indications: Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1 of SPC. Warnings and Precautions: Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis and for one month after stopping treatment. Tafamidis should be added to the standard of care for the treatment of patients with transthyretin amyloidosis. Physicians should monitor patients and continue to assess the need for other therapy, including the need for organ transplantation, as part of this standard of care. As there are no data available regarding the use of tafamidis in organ transplantation, tafamidis should be discontinued in patients who undergo organ transplantation. Increase in liver function tests and decrease in thyroxine may occur. This medicinal product contains no more than 44 mg sorbitol in each capsule. Sorbitol is a source of fructose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Pregnancy and Lactation:

Tafamidis is not recommended during pregnancy and in women of childbearing potential not using contraception. Available data in animals have shown excretion of tafamidis in milk. A risk to the newborns/infants cannot be excluded. Vyndaqel should not be used during breastfeeding. Interactions: In a clinical study in healthy volunteers, 20 mg tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4. In vitro tafamidis inhibits the efflux transporter BCRP (breast cancer resistant protein) at the 61 mg/day tafamidis dose with IC50=1.16 μM and may cause drug-drug interactions at clinically relevant concentrations with substrates of this transporter (e.g. methotrexate, rosuvastatin, imatinib). In a clinical study in healthy participants, the exposure of the BCRP substrate rosuvastatin increased approximately 2-fold following multiple doses of 61 mg tafamidis daily dosing. Likewise, tafamidis inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) with IC50=2.9 μM and IC50=2.36 μM, respectively, and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters (e.g. non-steroidal anti-inflammatory drugs, bumetanide, furosemide, lamivudine, methotrexate, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, zidovudine, zalcitabine). Based on in vitro data, the maximal predicted changes in AUC of OAT1 and OAT3 substrates were determined to be less than 1.25 for the tafamidis 61 mg dose, therefore, inhibition of OAT1 or OAT3 transporters by tafamidis is not expected to result in clinically significant interactions. No interaction studies have been performed evaluating the effect of other medicinal products on tafamidis. Undesirable Effects: The following adverse events were reported more often in 176 ATTR-CM patients treated with tafamidis meglumine 80 mg compared to placebo: flatulence [8 patients (4.5%) versus 3 patients (1.7%)] and liver function test increased [6 patients (3.4%) versus 2 patients (1.1%)]. A causal relationship has not been established. Safety data for tafamidis 61 mg are available from its open-label long-term extension study. Adverse reactions from cumulative clinical data in ATTR-CM participants: Common (≥ 1/100 to < 1/10) Diarrhoea, rash, pruritus. Legal category: S1A. Marketing Authorisation Numbers: EU/1/11/717/003–61mg (30 capsules). Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at medical.information@pfizer.com. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500.

Last revised: 02/2023

Ref: VY 61MG 3_0

ATTR-CM, transthyretin amyloid cardiomyopathy; CV, cardiovascular 1. VYNDAQEL 61 mg (tafamidis) Summary of Product Characteristics, 2023. 2. Maurer MS et al. ATTR-ACT study investigators. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018; 379:1007–1016. 3. Witteles RM et al. Screening for transthyretin amyloid cardiomyopathy in everyday practice. JACC Heart Fail. 2019; 7:709–716. 4. Maurer MS et al. Addressing common questions encountered in the diagnosis and management of cardiac amyloidosis. Circulation. 2017; 135:1357–1377. 5. Rozenbaum MH et al. Estimating the health benefits of timely diagnosis and treatment of transthyretin amyloid cardiomyopathy. J Comp Eff Res. 2021; 10:927–938. 6. Rapezzi C. Efficacy and safety of tafamidis in transthyretin amyloid cardiomyopathy: results of the ATTR-ACT trial. European Society of Cardiology Congress 25–29 August, 2018.

PP-VYN-IRL-0236. May 2024.

Cardiac Society, Annual Scientific Meeting and AGM, Great Southern Hotel, Killarney, Co Kerry, 16-18 October 2025

PROGRAMME

Empowering people worldwide to live healthier at every stage of life

With 1,600 people working across five sites in Ireland, Viatris provides access to medicines, develops innovative solutions and improves healthcare for patients.

Job Code: CC-2023-001

Date of Preparation: July 2023

www.viatris.ie

Viatris

Newenham Court, Malahide Road, Dublin 17, Dublin, Ireland.

Viatris.ie

Empowering people worldwide to live healthier at every stage of life

With 1,600 people working across five sites in Ireland, Viatris provides access to medicines, develops innovative solutions and improves healthcare for patients.

Job Code: CC-2023-001

Date of Preparation: July 2023

www.viatris.ie

Viatris

Newenham Court, Malahide Road, Dublin 17, Dublin, Ireland.

Viatris.ie

Key national meeting for haematologists to take place next month

The upcoming Haematology Association of Ireland Annual Meeting will showcase the latest clinical and research developments in the specialty

The Haematology Association of Ireland (HAI) will hold its Annual Meeting on 10-11 October at the Radisson Hotel, Athlone, Co Westmeath. e programme brings together Irish and international experts to highlight developments in haematology ranging from myeloproliferative neoplasms and leukaemia to CAR T-cell therapies. e meeting also provides a platform for oral and poster presentations, trainee education, and professional networking.

HAI President Prof Paul Browne will open the meeting. In his address, Prof Browne will set the stage for what is expected to be a highly practical and clinically relevant event.

Following the address, the rst session will begin with oral abstract presentations, giving researchers an opportunity to showcase current work.

State-of-the-art lectures

Attention then shifts to the rst state-ofthe-art lecture, where Prof Andreas Reiter of the University Medical Centre, Mannheim, Germany, will speak on myeloproliferative neoplasms (MPNs). Prof Reiter is internationally recognised for his work in this eld. He has contributed to several landmark studies, including the JAKARTA and RESPONSE trials, a multicentre study of imatinib in hypereosinophilic syndrome (HES), and the development of a MPN patient registry to support more precise treatment decisions.

His research also focuses on rare MPNs, applying modern sequencing approaches and examining organ involvement to improve the distinction between chronic eosinophilic leukaemia, HES, and reactive eosinophilia.

Following a short break after Prof Reiter’s talk, Dr Nina Orfali, Consultant Haematologist, St James’s Hospital, Dublin, will take the podium to review advances

in relation to transplantation and leukaemia. Dr Orfali is a medical graduate of the University of Galway. After completing her internal medicine training between Galway University Hospital and the Mayo Clinic, Minnesota, US, she branched into laboratory research, spending three years in laboratories at the Cork Cancer Research Centre and Weill Cornell University, New York, US. Dr Orfali was awarded a PhD from University College Cork for her work on the role of autophagy in leukaemic cell di erentiation.

Dr Orfali trained as a haematology specialist here in Ireland and then returned to Cornell University to undertake further specialist training in stem cell transplantation for two years. She moved to Dublin in 2020 to take up her position on the adult bone marrow transplant team at St James’s Hospital.

Her lecture promises to provide practical insights from a frontline clinical perspective.

e next lecture will feature Dr Maeve O’Reilly, Honorary Lecturer, University College London. Her presentation will address CAR T-cell therapy and lymphoma, an area where clinical trials and real-world data continue to evolve rapidly.

Following the HAI Annual General Meeting and lunch, Dr Catherine Cargo, Consultant Haematologist, Leeds University Hospital, UK, will speak about myelodysplastic

Haematology Association of Ireland, Annual Meeting, Radisson Hotel, Athlone, Co Westmeath, 10-11 October 2025

syndromes. is state-of-the-art lecture is expected to highlight recent diagnostic criteria and their implications for patient care.

Next on the agenda is another stateof-the-art lecture and then the President’s Symposium.

Liam O'Connell Lecture

e rst day will close with the Liam O’Connell Lecture, one of the traditional highlights of the HAI meeting. is year’s lecture will be given by Dr Mohandas Narla, Head, Laboratory of Red Cell Physiology, New York Blood Centre, US. Dr Narla will speak about red cell disorders, drawing from decades of laboratory and translational research.

His work has advanced understanding of the molecular and structural basis of red cell membrane disorders, as well as the mechanisms underlying thalassaemia and sickle cell anaemia. He has characterised how Plasmodium falciparum infection alters red cell structure and function. Dr Narla’s research has also focused on the molecular regulation of erythropoiesis, with particular attention to disordered red cell production in conditions such as Diamond-Blackfan anaemia and myelodysplasia.

Following the lecture, there will be an ofcial poster viewing and adjudication, providing younger researchers and trainees a platform to share their work in an interactive format.

Day two

e second day again begins with oral abstract presentations. ese sessions are often the most diverse part of the meeting, re ecting the breadth of clinical and scienti c activity across Ireland. e opening state-of-the-art lecture of the day will be delivered by Dr Mary Gleeson, Consultant Haematologist, Guy’s and St omas’ NHS Foundation Trust, London, UK. Her topic is T-cell lymphoma, with a focus on current treatment challeng-

e rst day will close with the Liam O’Connell Lecture, one of the highlights of the HAI meeting

es and research directions. Dr Gleeson has a special interest in lymphoma, clinical research, and lymph node diagnostics.

Following specialist training in haematology, she completed a clinical research Fellowship at the Royal Marsden, where she worked on UK National Cancer Research Institute clinical trials in di use large B-cell lymphoma and peripheral T-cell lymphoma, and earned a Doctorate in Medical Research from the University of London.

Dr Gleeson is a member of the RCPI, the Royal College of Pathologists (UK), and the European Haematology Association. She is Research and Development Lead for Haematology at Guy's Hospital, Principal Investigator for lymphoma clinical trials, and also leads early-phase trials at the Sarah Cannon Research Institute in London.

After the mid-morning break, the programme turns to clinical vignette presentations, a format that allows trainees to present instructive or unusual cases. is session continues to be a valued educational part of the HAI Annual Meeting. e nal state-of-the-art lecture of the conference will be given by Dr Michael Desborough, Consultant Haematologist, Oxford University Hospitals NHS Foundation Trust, UK. He will discuss foetal and neonatal alloimmune thrombocytopaenia (FNAIT).

Dr Desborough leads a research programme focused on developing and trialling new treatments for platelet disorders, with a particular emphasis on identifying alternatives to platelet transfusion. His work spans several key areas, including clinical trials to reverse antiplatelet drugs in intracerebral haemorrhage, optimising the management of FNAIT, and advancing therapies in transfusion medicine and immunohaematology. is includes conditions such as thrombotic thrombocytopenic purpura, immune thrombocytopenia, warm autoimmune haemolytic anaemia, and cold agglutinin disease.

rough these projects, Dr Desborough is building the evidence-base to re ne platelet transfusion practice and support the development of e ective alternatives. e formal programme concludes with the awarding of educational prizes, recognising excellence in both abstract presentations and posters.

After lunch, there will be a dedicated educational session for specialist registrars, registrars, and trainees in haematology, reinforcing the HAI’s commitment to professional development and mentoring.

Prof Paul Browne

Dr Nina Orfali

Dr Michael Desborough

Dr Mohandas Narla

Haematology Association of Ireland, Annual Meeting, Radisson Hotel, Athlone, Co Westmeath, 10-11 October 2025

PROGRAMME

FRIDAY 10 OCTOBER

PRESCRIBING INFORMATION

8.00 – 08.45

TEA/COFFEE/MEET THE SPONSORS –

(All sponsors have supported this meeting through the sponsorship of exhibition space alone. They have had no input into the agenda, speaker selection, or content of this meeting)

Prof Andreas Reiter, University Medical Centre, Mannheim, Germany Topic: Myeloproliferative neoplasms

–

Dr Nina Orfali, St James’s Hospital, Dublin Topic: Transplant/Leukaemia

Dr Mohandas Narla, New York Blood Centre,

REZZAYO (rezafungin) 200 mg powder for concentrate for solution for infusion RoI PRESCRIBING INFORMATION Refer to Summary of Product Characteristics (SmPC) before prescribing. Presentation: Each vial contains 200 mg rezafungin (as acetate). Powder for concentrate for solution for infusion. White to pale yellow cake or powder. Indication: REZZAYO is indicated for the treatment of invasive candidiasis in adults. Consideration should be given to o cial guidance on the appropriate use of antifungal agents. Dosage and administration: A single 400 mg loading dose on Day 1, followed by 200 mg on Day 8 and once weekly thereafter. The duration of treatment should be based upon the patient’s clinical and microbiological response. In general, antifungal therapy should continue for at least 14 days after the last positive culture. During clinical trials patients were treated with rezafungin for up to 28 days. The safety information on rezafungin treatment durations longer than 4 weeks is limited. For intravenous use only. After reconstitution and dilution, the solution should be administered by slow intravenous infusion over approximately 1 hour, infusion time may be increased up to 180 minutes to manage any evolving symptoms of infusion-related reaction. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to other medicinal products of the echinocandin class. Warnings and precautions: The e cacy of rezafungin has only been evaluated in a limited number of neutropenic patients. Hepatic e ects: In clinical trials, elevations in liver enzymes have been seen in some patients treated with rezafungin. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with rezafungin, clinically significant hepatic dysfunction has occurred; a causal relationship to rezafungin has not been established. Patients who develop elevations in liver enzymes during rezafungin therapy should be monitored and the risk/benefit of continuing rezafungin therapy should be re-evaluated. Infusion-related reactions: Transient infusion-related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness. In clinical trials, infusion reactions resolved within minutes, some without interruption or discontinuation of the infusion. Patients should be monitored during the infusion. If the infusion is stopped due to a reaction, consideration may be given to restarting the infusion at a slower rate after the symptoms have resolved. Phototoxicity: Rezafungin may cause increased risk of phototoxicity. Patients should be advised to avoid sun exposure and other sources of UV radiation without adequate protection during treatment and for 7 days after the last administration of rezafungin. Interactions: The drug-drug interaction potential of rezafungin with a number of probe substrates of cytochrome P450 enzymes and/or transporter proteins has been assessed clinically. The need for dose adjustments is considered unlikely for medicinal products that are substrates for the CYP2C8, CYP3A4, CYP1A2, and CYP2B6 enzymes and P-gp, BCRP, OATP, OCT1, OCT2, MATE1, and MATE2 transporter proteins, when administered with rezafungin. The drug-drug interaction potential of rezafungin with a number of co-administered medicinal products has also been assessed clinically. The need for dose adjustments is considered unlikely for tacrolimus, cyclosporine, ibrutinib, mycophenolate mofetil, and venetoclax when administered with rezafungin. In vitro, rezafungin is metabolically stable and was found not to be a substrate for BCRP, P-gp, MRP2, OATP1B1, OATP1B3, OCT1, OCTN1, and OCTN2 transporter proteins. Therefore, the need for dose adjustments of rezafungin is considered unlikely when rezafungin is co-administered with other medicinal products. Fertility, pregnancy and lactation: There are no data from the use of rezafungin in pregnant women. Studies in animals did not show reproductive or developmental toxicity. Rezafungin has been shown to cross the placental barrier in animal studies. The potential risk for humans is unknown. Rezafungin is not recommended to be used during pregnancy and in women of childbearing potential not using contraception unless the benefit outweighs the potential risk to the foetus. There are no data from the use of rezafungin in lactating women. It is unknown whether rezafungin or its metabolites are excreted in human milk. Rezafungin excretion into milk was observed in rats. No data on the e ect of rezafungin on human fertility are available. Rezafungin did not a ect fertility in female rats or reproductive performance in male rats, despite reversible testicular e ects in male rats. Side e ects: Based on clinical trial experience, the most frequently reported adverse reactions for rezafungin were hypokalaemia, pyrexia, and diarrhoea (very common adverse reactions(≥ 1/10)). Common adverse reactions (≥ 1/100 to < 1/10 ) were: anaemia, hypomagnesaemia, hypophosphataemia, hypotension, wheezing, vomiting, nausea, abdominal pain, constipation, erythema, rash, blood alkaline phosphatase increased, hepatic enzymes increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased. Transient infusion-related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness. Uncommon (≥ 1/1 000 to < 1/100) were: hyperphosphataemia, hyponatraemia, phototoxicity, tremor, increased eosinophil count. Unknown incidence: urticaria. Refer to the SmPC for details on full side e ect profile and interactions. Classification: POM Marketing authorisation (MA): EU/1/23/1775/001 Name and address of MA holder: Mundipharma GmbH, De-Saint-Exupery-Strasse 10, Frankfurt Am Main, 60549, Germany. Tel: 01223424444.

Additional information is available on request. For medical information enquiries, please contact medicalinformation@mundipharma.ie IE-RZF-2400001 November 2024

REZZAYO® rezafungin

a next generation echinocandin for an evolving treatment landscape1-3

Learn more about the benefits of REZZAYO® Visit https://pro.mundipharma.com/ie/rezzayo/rezzayo-introduction Or scan here:

REZZAYO ® is an echinocandin with a differentiated PK/PD profile, 4,5 indicated for the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents. 4

Prescribing information can be found overleaf.

1. Thompson GR III, et al. Lancet 2023;401(10370):49–59.

2. World Health Organization. WHO fungal priority pathogens list to guide research, development and public health action, 2022. https://www.who.int/publications/i/ item/9789240060241. Accessed March 2025.

3. Salmanton-García J, et al. J Infect 2024; epub ahead of print. doi: https://doi. org/10.1016/j.jinf.2024.106229.

4. REZZAYO® (rezafungin). Summary of Product Characteristics. Mundipharma 2023.

5. Sandison T, et al. Antimicrob Agents Chemother 2016;61:e01627-16.

Reporting adverse events

Adverse events should be reported to HPRA Pharmacovigilance. Reporting forms and information can be found at www.hpra.ie Email: medsafety@hpra.ie

Adverse events should also be reported to Mundipharma Pharmaceuticals Limited on +44 1748 828867 or email drugsafetyUKandROI@mundipharma.com

SEPTEMBER

WEDNESDAY 17

3rd National Patient and Public Partnership Conference, Croke Park, Drumcondra, Dublin 3.

The HSE National Patient and Public Partnership Conference brings together health and social care professionals and patient/service user partners to celebrate and advance meaningful partnership in healthcare. The theme of this year’s conference is ‘Navigating our patient partnership journey together’. Visit https://healthservice.hse.ie

THURSDAY 18 – FRIDAY 19

Irish Society for Rheumatology (ISR), Autumn Meeting, Radisson Blu Hotel, Little Island, Cork. The ISR’s Autumn Meeting is a key event in the Society’s calendar. The ISR comprises of members with specialist training in rheumatology. They include consultants, trainees, scientists, and researchers. The Society includes those who are based in the Republic of Ireland, Northern Ireland, the rest of the UK and some from further afield. The ISR organises and hosts regular platforms and conferences allowing members to present clinical and scientific material. Visit https://isr.ie

FRIDAY 19

Annual Dr Sarah Fitzgibbon Lecture, Women in Medicine in Ireland Network, RCSI, St Stephen’s Green, Dublin 2. This year’s Dr Sarah Fitzgibbon Lecture will be delivered by Prof Suzanne Crowe, President of the Irish Medical Council, and Consultant in Paediatric Intensive Care and Anaesthesiology, Children’s Health Ireland. Prof Crowe is a strong voice for healthcare improvement, reducing health inequities, and supporting underserved communities. This event is organised by the Women in Medicine in Ireland Network. Visit https://www.wimin.ie

FRIDAY 19

Irish Epilepsy League, Annual Epilepsy Expert Day, Gibson Hotel, Point Square, Dublin 1. This meeting promises to have something for everyone involved in the field of epilepsy. The expert speakers will include Prof Jacqueline French, Comprehensive Epilepsy Centre, NYU Langone School of Medicine, US, and Prof Katja Kobow, Department of Neuropathology, Universitätsklinikum Erlangen, Germany. The event will also feature clinical case presentations, updates, and the annual debate. The meeting is aimed at healthcare professionals and researchers. Visit https://www.irishepilepsyleague.com

SATURDAY 20

Epilepsy Ireland National Conference, Gibson Hotel, Point Square, Dublin 1. This conference is an important opportunity for people to meet with others living with epilepsy and hear about topics of interest to the epilepsy community. The conference will feature expert talks on treating and managing the condition.Visit https://www.epilepsy.ie

WEDNESDAY 24 – FRIDAY 26

18th International Symposium on Translational Research in Oncology, Herbert Park Hotel, Ballsbridge, Dublin 4. This conference is organised by Cancer Clinical Research Trust (CCRT), a registered charity founded by Prof John Crown. It supports a translational cancer research programme under the leadership of the CCRT board of directors. Over 35 internationally renowned speakers will present on latest advances in cancer research and treatments. Confirmed speakers include Prof Sara Hurvitz, Fred Hutchinson Cancer Centre, US; Dr Mark Pegram,

Stanford University School of Medicine, US; Prof Robert Kerbel, University of Toronto, Canada; Prof Lajos Pusztai, Yale University, US; Prof Patrick Forde, Trinity St James’s Cancer Institute, Trinity College Dublin; Prof Cyrus Ghajar, Fred Hutchinson Cancer Centre, US; and Prof Grainne O’Kane, Pat Smullen Chair in Pancreatic Cancer, University College Dublin. Visit https://ccrt.ie

THURSDAY 25 – FRIDAY 26

Faculty of Radiologists and Radiation Oncologists, Annual Scientific Meeting, RCSI, 123 St Stephen’s Green, Dublin 2. This is the Faculty’s major annual scientific gathering. Scientific sessions and a poster exhibition will form an important part of the meeting. Visit https://www.radiology.ie

OCTOBER

WEDNESDAY 1

Eye Care in Focus Conference, Gibson Hotel, Point Square, Dublin 1. This annual conference, now in its fourth consecutive year, is organised by the Irish College of Ophthalmologists (ICO). This is a oneday clinical education conference for the extended eye care team (ophthalmologists, orthoptists, optometrists, ophthalmic nurses, technicians, and opticians) working across the public and private healthcare system. Further details will be posted on the ICO’s website. Visit https://www.eyedoctors.ie

FRIDAY 10

24th Annual Neurology Update Meeting, O’Reilly Hall, University College Dublin, Dublin 4. This is an Irish Institute of Clinical Neuroscience meeting under the directorship of Dr Petya Bogdanova–Mihaylova, Consultant Neurologist, Tallaght University Hospital, Dublin. This education day will be of interest to neurologists, general physicians, and general practitioners. The meeting will be relevant for specialists and generalists who manage neurological illness. Speakers will present new developments in diagnosis and treatment in a practical ‘what you need to know’ format, with short talks and clinical insights for the management of neurological patients. Visit https://iicn.ie

FRIDAY 10 – SATURDAY 11

Irish Society of Urology, Annual Meeting, Radisson Blu Hotel and Spa, Ballincar, Rosses Point, Co Sligo. For queries or to be included on the mailing list, email: isuevents@rcsi.ie Visit https://www.rcsi.com

FRIDAY 10 – SATURDAY 11

Haematology Association of Ireland (HAI), Annual Conference, The Radisson Hotel, Athlone, Co Westmeath. The HAI nurtures the development of haematology knowledge and research on the island of Ireland. Its Annual Meeting features expert national and international speakers presenting on the latest clinical practice and research in haematology. Visit https://www.haematologyireland.ie

SATURDAY 11

Annual Interventional Radiology Nurses Conference, Mater Misericordiae University Hospital, Dublin 7. This conference is organised by the Association of Nurses in Radiology of Ireland. Visit https://www.eventbrite.ie

THURSDAY 16 – SATURDAY 18

Irish Cardiac Society (ICS), Annual Scientific Meeting and AGM, Killarney, Co Kerry. Established in 1949, the Irish Cardiac Society is the professional society in Ireland for those whose primary interest is in the practice of cardiology, cardiovascular surgery, and cardiovascular research. Visit https://irishcardiacsociety.ie

SATURDAY 18

Irish Society of Lifestyle Medicine, Annual Conference, RCSI, St Stephen’s Green, Dublin 2. The Irish Society of Lifestyle Medicine is an independent, evidence-based, not-for-profit organisation that recognises lifestyle as a leading cause of disease and therefore as an appropriate medical intervention, alongside usual medical care. The Society is a north-south multidisciplinary organisation promoting lifestyle as medicine for disease prevention, management and health promotion. Visit https://www.islm.ie

NOVEMBER

FRIDAY 7 – SATURDAY 8

49th Annual Meeting, Irish Endocrine Society (IES), Portlaoise, Co Laois. The IES aims to promote the development of endocrinology through education and interchange of scientific material. Membership is open to all physicians, surgeons, gynaecologists, scientists, and laboratory technologists with a significant interest in diabetes and endocrinology. The local organiser for the 2025 IES Annual Meeting is Dr Ma Pyeh Kyithar, Consultant Endocrinologist and Physician, Midland Regional Hospital, Portlaoise. Visit https://irishendocrinesociety.com

THURSDAY 20 – FRIDAY 21

Irish Society of Gastroenterology (ISG), Winter Meeting, Killashee Hotel, Naas, Co Kildare. The Winter Meeting is a seminal event in the calendar of the ISG. The ISG comprises of medical specialists working in the field of gastrointestinal and liver disease and associated research. The Society also caters for specialist trainees and non-medical scientists. The majority of members are located in or have links to Ireland. The ISG organises and hosts regular platforms and conferences allowing members to present clinical and scientific material. Visit https://isge.ie

THURSDAY 20 – SATURDAY 22

Irish Thoracic Society (ITS), Annual Scientific Meeting, Galway Bay Hotel. This is a key date in the calendar of the ITS. The Society is the national organisation representing respiratory healthcare professionals throughout Ireland. It is dedicated to championing excellence in the prevention, diagnosis, and clinical care of respiratory disease through its work in advocacy, education, and research. Registration for its Annual Scientific Meeting has opened. Visit https://irishthoracicsociety.com

DECEMBER

TUESDAY 9

University College Dublin (UCD) One Health Conference, O’Reilly Hall, UCD, Belfield, Dublin 4. This year’s UCD One Health Annual Conference will bring together internationally renowned speakers and showcase the depth and breadth of UCD and Ireland’s One Health expertise. From cutting-edge research and education to policy, public health, agriculture, and environmental action, contributors will span government, academia, civil society, and international organisations. This will be a great opportunity to engage with leaders shaping the future of One Health in a complex and interconnected world. Speakers include: Prof Lisa Boden, Chair of Population Medicine and Veterinary Public Health Policy, University of Edinburgh, UK; and Prof Katie Woolaston, KW Green Governance Solutions and Adjunct Research Fellow, Griffith University, Australia.Visit https://www.ucd.ie/onehealth/

Q1 Who was named as inter-county manager of the Dublin men’s senior football team? A: Ger Brennan

Q2 Which English golfer won the St Jude Classic this month and, in doing so, secured his place for the seventh time on the European Ryder Cup team? A: Justin Rose

Q3 What country will host the upcoming women’s Rugby World Cup? A: England

Q4 Who won English football’s curtain raiser, the Community Shield, earlier this month? A: Crystal Palace

Q5 Who was named player of the series from the British and Irish Lions tour of Australia? A: Tadhg Beirne

Q6 Name the former world snooker champion who has been named as Chair of the new Professional Snooker Players Association? A: John Higgins

JOHNSON & JOHNSON INNOVATIVE MEDICINE PARTNERS WITH MULTIPLE MYELOMA IRELAND TO LAUNCH THE 2025 ‘MILES FOR MYELOMA’

CHALLENGE

Johnson & Johnson (J&J) staff have embarked on the first mile of the 2025 ‘Miles for Myeloma’ challenge with Multiple Myeloma Ireland (MMI), kicking off the annual month-long challenge at J&J’s state-of-the-art biopharmaceutical site in Ringaskiddy, Cork.

This September, during Blood Cancer Awareness Month, the J&J team from Cork and the commercial organisation in Dublin have joined forces to walk, run, cycle, and swim to clock up Miles for Myeloma and raise funds for this important cause.

HSE APPROVES MIRIKIZUMAB▼ FOR THE TREATMENT OF ELIGIBLE ADULTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Eli Lilly and Company has announced that the HSE has approved mirikizumab for the treatment of adult patients who have had moderately to severely active ulcerative colitis (UC) who had inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. Reimbursement is restricted to use as a subsequent line of therapy following treatment with a lower-cost biologic therapy.

“This decision means mirikizumab will now be made available in Ireland for the treatment of adults with moderate to severe ulcerative colitis. Ulcerative colitis is a chronic, relapsing inflammatory disorder affecting the large intestine. It is characterised by symptoms of diarrhoea, bleeding, and urgency, and often has negative effects on patients’ personal, psychological, professional, and social wellbeing,” said Prof Glen Doherty, Consultant Gastroenterologist at the Centre for Colorectal Disease at St Vincent’s University Hospital, Dublin. “I am delighted that an additional treatment option will now be available through Ireland’s healthcare system for eligible patients diagnosed with ulcerative colitis.”

Ms Victoria Spillane, Chief Operating Officer of Crohn’s & Colitis Ireland, commented: “Over 40,000 people in Ireland are living with Crohn’s disease and ulcerative colitis. They are lifelong conditions for which there is no known cure and the symptoms are painful and debilitating. Existing medications may not work for some people or indeed stop working for others. Expanding the treatment options for eligible people living with colitis

MMI is the only charitable organisation in Ireland working to empower people affected by multiple myeloma and related conditions to live full lives, offer crucial support, education, and advocacy. The longstanding partnership between J&J and MMI underscores a shared mission to advance patient care and support critical research, truly making a difference in the lives of those affected by this challenging disease.

Visit www.multiplemyelomaireland.org to find out more.

is a promising step forward and we welcome the HSE’s decision to recommend mirikizumab.”

This approval for reimbursement was based on results from the LUCENT programme, which included two randomised, double-blind, placebo-controlled phase 3 clinical trials, consisting of one 12-week induction study (LUCENT-1) and one 40-week maintenance study (LUCENT-2) for 52 weeks of continuous treatment.

▼ This medicinal product is subject to additional monitoring. Healthcare professionals are asked to report any suspected adverse reactions via the Health Products Regulatory Authority website: www.hpra.ie/reportan-issue/medicines-for-human-use/side-effects Adverse events and product complaints should also be reported to Lilly on 01 664 0446.

CHRONIC PAIN IRELAND LAUNCHES NATIONAL CAMPAIGN TO TACKLE STIGMA FOR PAIN AWARENESS MONTH

Chronic Pain Ireland has launched its 2025 Pain Awareness Month campaign with the theme ‘Beyond the surface’, focusing on the hidden struggle and stigma surrounding chronic pain.

Chronic pain – defined as pain lasting longer than three months – often arises from injury, illness, or unknown causes. It can affect anyone, at any age, and has wide-reaching impacts on mental health, mobility, work, relationships, and quality-of-life.

It is one of the most prevalent health issues in Ireland, yet it continues to receive limited recognition, understanding, and visibility. Many people living with chronic pain report not being believed – even by healthcare professionals, employers, and family members.

Throughout September, Chronic Pain Ireland will host free workshops and events to mark Pain Awareness Month. The public is invited to join the global campaign using the hashtag #PainAwarenessMonth.

Chronic pain is a leading reason people reduce or leave work, withdraw from daily activities and experience long-term disability. According to the Irish Pain Society, chronic pain costs the Irish economy over €4.7 billion annually.

Despite the cost, chronic pain remains under-recognised and underfunded in Ireland and across Europe. Chronic Pain Ireland and the Societal Impact of Pain (SIP) Ireland are calling for urgent investment in prevention and early intervention, including:

▶ Public health campaigns to raise awareness and improve health literacy.

▶ Structured education and exercise programmes in healthcare and workplace settings.

▶ Timely access to biopsychosocial rehabilitation for people at risk of long-term pain.

▶ Inclusive employment policies that support job retention and return to work.

▶ Stronger primary care pathways to ensure early diagnosis and treatment.

Ms Christina Donnelly, Executive Director of Chronic Pain Ireland, said: “Chronic pain is a heavy burden as often pain is invisible. Stigma adds more weight to that burden, wearing you down, impacting on mental health and wellbeing. This campaign aims to bring that pain to the surface – to challenge and end pain stigma, to help promote understanding, and to call for a system that believes and supports people from the start.”

Chronic Pain Ireland member Ms Elizabeth Mansfield said: “My pain is real, but invisible. When people can’t see it, they doubt it, question it, lose patience with you by thinking you are making it all up. That doubt slowly wears you down physically and mentally. This campaign matters because it gives us a voice – and helps others see what we live with every day.”

University of Galway Professor of Clinical Psychology and representative for SIP Ireland, Prof Brian McGuire, said: “We have the tools to prevent chronic pain from becoming a lifelong disability, but people are still falling through the cracks. We need a coordinated, compassionate response – one that sees pain not just as a symptom, but as a priority in its own right.” For further information, visit www.chronicpain.ie

EUROPEAN COMMISSION AUTHORISES TWICE-YEARLY LENACAPAVIR (YEYTUO) FOR HIV PREVENTION

Gilead Sciences has announced that the European Commission (EC) has granted marketing authorisation for lenacapavir for pre-exposure prophylaxis (PrEP) (under the brand name Yeytuo) – the company’s twice-yearly injectable HIV-1 capsid inhibitor – for use in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk, who weigh at least 35kg. Initiation of lenacapavir requires two days of oral tablets at the time of the first injection. Lenacapavir for PrEP is licensed for use in the European Union’s 27 member states, as well as Norway, Iceland, and Liechtenstein. The marketing authorisation application was reviewed under an accelerated timeline based on the assessment by the European Medicines Agency’s committee for medicinal products for human use (CHMP) that twice-yearly lenacapavir for PrEP is a product of major interest for public health. In July, the CHMP adopted a positive opinion recommending lenacapavir for PrEP for EC authorisation.

The EC decision follows authorisation by the US Food and Drug Administration in June, as well as the issuance of guidelines by the World Health Organisation in July that recommended twice-yearly lenacapavir as an additional PrEP option for HIV prevention.

The teams from Johnson & Johnson Innovative Medicine and Multiple Myeloma Ireland

Clinical/reception rooms available for rent in medical centre opposite University College Dublin. Would suit paramedic or psychologist. Free parking.

Phone 086 827 6508 or email kevinalicegriffin@gmail.com

September is lung fibrosis awareness month

Interstitial lung diseases – ILDs are a group of lung disorders with the potential to display a progressive fibrotic phenotype and be termed progressive pulmonary fibrosis or lung fibrosis. ILDs can cause irreversible lung damage, leading to early mortality. It primarily affects males over the age of 60 with a history of smoking or environmental exposures.

If your patient fits this profile and you detect dry inspiratory crackle on lung auscultation, especially if pulmonary function test/spirometry follows an ILD (restrictive spirometry) pattern, a CT Thorax should be ordered with referral to one of Ireland’s eight ILD specialist centres.

As a medical professional you have legal obligations when it comes to Data Protection and GDPR. Eileen Ireland (Certified Data Protection Officer) is here to help you with whatever your GDPR questions and needs are.

BESPOKE TRAINING FOR BUSINESSES

Now offering a three hour long CPD Accredited training on the fundamentals of GDPR. This is tailored to your business/organisation and full of practical advice on how to implement a GDPR programme. The training is comprehensive and covers everything from your basic GDPR principles to how to respond to a Data Subject Access Request and what to do if a Data Breach takes place within your organisation.

Irish Lung Fibrosis Association (ilfa.ie)

A round-up of news and oddities from left field by Dr Doug Witherspoon

What’s so funny about dying? Laughing in the face of the inevitable

Finding humour in daily life has many positive psycho-social benefits – but what about when we are faced with serious and life-limiting illness? It raises the question: What happens to a patient’s mind when they are confronted with

serious illness or disability and where does their sense of humour come into the equation?

Serious and potentially fatal illness deconstructs the ‘self’ like no other event in life. These events can challenge our identity as that sense of control over life withers away.

For words of wisdom on the topic, there is a fascinating article from 2022 in Psychology Today by medical doctor Dr Daniel Miller, titled ‘Humour, Serious Illness, and End of Life’.

“And what is a life-limiting illness, if not an absurdity?” posits Dr Miller. As any physician knows, when faced with disastrous news, patients react in different ways – some blame past misdeeds, others just put it down to genetic bad luck, some adapt to the new circumstances, while others may develop a nihilistic frame of mind.

“Absurdist or surreal humour can both reveal an odd similarity to the person’s existential predicament and at the same time evoke a bit of catharsis so needed when one is solely preoccupied with their struggle,” according to Dr Miller, who is a palliative care specialist.

Naturally, engaging with humour with a seriously ill patient is delicate. Inappropriately used, it can be a disaster for the doctor-patient relationship. But used judiciously, it can serve to enhance that relationship.

In profound suffering, “our worldview shrinks tremendously,” he writes.

“It shrinks into the black hole of suffering with a mass of a thousand suns. Hope, joy, pleasantries, goodwill, connection with others, meaning in life just disappear. We become less than human. We are taken over by the suffering.

Heart failure and iron defi ciency: Guidelines and practicalities

“What humour allows is the reconnection of one’s suffering with their humanity and brings just a bit of temporary joy back into view. It’s not a panacea, but it makes its mark. It’s a therapy that only we humans can share with other humans without needing any technology, pills, or procedures. All that is required is lived experience, a bit of tact, and a sense of humour.”

From the patient’s perspective, a ‘good doctor’ is one who sees the patient on time and is competent. A ‘great doctor’ is the one who is also competent, but has a warm and skilled bedside manner, he points out.

“So, why use humour?” Dr Miller asks.

“To build rapport, to form a connection, to create a less threatening space where psychological suffering can take a back seat (even temporarily) to a more positive frame of reference, to achieve catharsis with a release of negative emotion/energy, to foster resilience in a very challenging situation, to allow one to think more broadly about their predicament, and get unstuck from their all-absorbing suffering and negative affect.

“Laughter is the closest distance between two people.”

Granted, the palliative care setting is a different world to a busy oncology ward in a general hospital, but the principles of humanity through humour still apply. So too does the need to foster the doctor-patient relationship, especially for the most vulnerable.

This is a concept worth thinking about, especially now that Palliative Care Week, which ran from 7-13 September, has come to a close

Palliative Care Week 2025 was led, as ever, by the All-Ireland Institute of Hospice and Palliative Care.

It’s the 12th year of the campaign and the 2025 theme was ‘Palliative Care: Living for Today, Planning for Tomorrow’.

To conclude, here are a few quotes from some familiar names on facing ‘the final curtain’.

“Always read something that will make you look good if you die in the middle of it.” PJ O’Rourke.

“Dying is a very dull, dreary affair. And my advice to you is to have nothing to do with it.” W Somerset Maugham

“This wallpaper and I are fighting a duel to the death. Either it goes, or I do.” Oscar Wilde’s final words.

“I am dying beyond my means.” Wilde again.

“If any of you cry at my funeral, I’ll never speak to you again.” Stan Laurel.

“This is no time to be making new enemies.” Voltaire after a priest asked him to renounce Satan.