MI2025-06-03

OUR PAPER IS NOW COMPOSTABLE, AS WELL AS RECYCLABLE 3 JUNE 2025 ● ISSUE 11 VOLUME 16 ● NEXT ISSUE 17 JUNE 2025 €5.95

Upskilling in genetics and genomics A recent international workshop hosted by the Mater Hospital aimed to address educational gaps in genomic medicine. David Lynch reports

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NEWS 1-14

Aid at a crossroads

Clothesline contemplations

As the US freezes foreign aid, Europe’s humanitarian leadership faces a crucial test, writes Bette Browne

Dr Lucia Gannon on why putting clothes out to dry is a means of connecting with all the women who came before her

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CONFERENCES 16, 28-34 & 36-38

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12-14

OPINION 17-19

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CLINICAL 20-26

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LIFE DIARY 40

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19

QUIZZES 41

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MOTORING 42

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GALLERIES 44 & 45

HSE confirms no extra funding for GPs’ CME NIAMH CAHILL

There is no planned increase in HSE funding for GP continuing medical education (CME) in 2025, a spokesperson for the Executive has told the Medical Independent (MI).

The HSE’s annual contribution to CME is “budget dependent”. The funding for 2026 has yet to be confi rmed, the spokesperson added.

It has been several years since the Irish College of GPs (ICGP) received any increase in CME funding. This situation has forced the College to offset funding deficits to ensure small group learning is maintained.

Dr Illona Duff y, Monaghan

GP and National Director of CME at the College, told MI that access to small group learning had been “a big problem” until recently.

“But the ICGP has provided temporary funding to provide CME tutors in areas that were closed. Galway and Waterford were closed for ages and the problem was both those areas were closely linked with GP training schemes. So we had GPs coming off training schemes who wanted to join groups, but there was no space for them.

“The ICGP said that despite not getting the funding from the HSE, they would provide funding for the time being for new tutors in those areas.”

Dr Duff y also said it had become challenging to fi nd new tutors. In the midlands (Roscommon, Mullingar, Longford), there was no CME tutor for more than three years. She stated that the role of a CME tutor can be difficult.

“It’s night-time work – you’re out in the evening, running the meeting, and you’re going along to three training workshops yourself a year and people aren’t doing it for the money because it’s poorly paid.”

A survey conducted by the College in 2024 showed there were 40 tutors and 161 small group meetings around the country. Some 2,863 GPs reported being members of a CME group, which are limited

to a maximum of 12 people.

Dr Duffy said there are now 43 tutors nationwide and “at the moment, there are very few areas that don’t have availability”.

“CME is different to other forms of education,” Dr Duffy explained. “The big difference is that CME brings about changes in clinical practice for patients. We know that from research, and we know that from feedback and surveys done on GP members of CME, who will say that it has changed their practice and also changed how they manage difficult situations and that’s why it’s important.”

CME groups are a forum in

Decline in approved consultant posts raised by NDTP Medical Director As reported in this newspaper in April, there was a 36 per cent fall in the number of consultant posts processed by the HSE last year, according The Medical Director of HSE National Doctors Trainto the CAAC’s annual report. The HSE’s consultant diing and Planning (NDTP) has raised concerns over vision processed a total of 347 consultant applications the recent decline in the number of consultant posts in 2024, which represented a reduction of 194 applicaapproved by the consultant applications advisory tions when compared to 2023. committee (CAAC).

Writing in the NDTP’s new Medical Workforce Analysis Report 2024-2025, Prof Anthony O’Regan said the drop could impact the continued expansion of the consultant workforce.

The NDTP report noted that the number of consultants employed has “increased dramatically” in recent times, rising from 3,089 in 2018 to 4,620 in 2024.

However, Prof O’Regan stated that the number of new and INVOKANA® is indicated for the treatment of adults with insufficiently controlled replacement posts approved by type 2 diabetes mellitus as an adjunct to diet and exercise: > as monotherapy when metformin is considered inappropriate due to the committee “dropped conintolerance or contraindications siderably” in 2024. > in addition to other medicinal products for the treatment of diabetes For study results with respect to combination of therapies, effects on glycaemic “This is likely to have an efcontrol, cardiovascular and renal events, and the populations studied, see fect on both the retention of sections 4.4, 4.5 and 5.1 of the Summary of Product Characteristics (SmPC). qualified specialists and the Legal category: POM. Marketing Authorisation number: EU/1/13/884/001-004 (100mg) and continued expansion of the EU/1/13/884/005-008 (300mg). Marketing Authorisation holder: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. Further information is available on request consultant workforce to meet from A. Menarini Pharmaceuticals Ireland, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SPC. demand growth.” See news Date of preparation: July 2023 IR-INV-42-2023. feature, p4-5.

DAVID LYNCH

which GPs – particularly newly trained GPs – can discuss challenges and troubleshoot issues, Dr Duff y stated. She added that the groups provide vital education, support, and collegiality, and also help GP retention.

The HSE’s spokesperson commented: “The HSE provides a contribution towards funding for CME and small group learning activities for GPs. However, the value of the contract is commercially sensitive and therefore we cannot supply this detail. Th is funding contribution is intended to help support the ongoing professional development of GPs who, as independent contractors, are not directly employed by the HSE.”

A combination of three

Parkinson’s therapies in a gel

formulation for intestinal infusion

Levodopa (20 mg/ml)

Carbidopa monohydrate (5 mg/ml)

Entacapone (20 mg/ml)

Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinal gel. 1 ml contains 20 mg levodopa, 5 mg carbidopa monohydrate and 20 mg entacapone. Indications: Treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results. Marketing authorisation holder: LobSor Pharmaceuticals AB, Kålsängsgränd 10 D, SE-753 19 Uppsala, Sweden.

Distributed by Clonmel Healthcare Ltd, Clonmel, Co. Tipperary.

Marketing authorisation number: PA23144/001/001. Medicinal product subject to medical prescription. Refer to the Summary of Product Characteristics (SmPC) for full prescribing information. A copy of the SmPC is available upon request or alternatively please go to: www.clonmelhealthcare.ie. Date of preparation: February 2023. 2023/ADV/LEC/026H

%

≥20

Weight loss experienced in 1 out of 3 patients at 68 weeks1,2 *«#†

~17%

FOR WEIGHT LOSS + CARDIOVASCULAR BENEFIT

goes beyond

Wegovy® is proven to treat obesity1,2,3 and reduce the risk of major cardiovascular (CV) events1,4 ¶

20

%

relative risk reduction for major CV events, including heart attack and stroke vs placebo1,4 ¶

mean weight loss sustained over 2 years1,3#§

Irish Clinical Practice Guidelines

Cardiology Guideline Update

Wegovy® is recommended in the Clinical Practice Guideline for the Management of Obesity in Adults in Ireland6

As recommended by the 2024 ESC Guidelines for the management of chronic coronary syndromes5‡

Patient and doctor portrayals.

For weight management, including weight loss and maintenance, in adults with an initial BMI of ≥30 kg/m2, or ≥27 to <30 kg/m2 with ≥1 weight-related comorbidity as an adjunct to a reduced-calorie diet and increased physical activity.1 For weight management in adolescents ≥12 years with obesity (BMI ≥ 95th percentile) and BW >60 kg as an adjunct to a reduced-calorie diet and increased physical activity.1 * Treatment policy estimand (assessed the treatment effects at week 68, regardless of treatment discontinuation or rescue intervention use). « The primary endpoint in the STEP 8 study was change in body weight (%) from baseline to week 68.

16.7% and 6.7 % mean weight loss reported in the Wegovy® and Liraglutide arms respectively.§ # Adults living with obesity (BMI ≥30 kg/m2), or with overweight (BMI ≥27 to <30 kg/m2) and at least one weight-related comorbidity. † This was a confirmatory secondary endpoint in STEP 8. § Trial product estimand (assessed treatment effect if a trial product was taken as intended). ¶ The primary endpoint in the SELECT clinical trial was the time from randomisation to first occurrence of major adverse cardiovascular events (MACE), defined as a composite endpoint consisting of cardiovascular death (including undetermined cause of death), non-fatal myo-cardial infarction, or non-fatal stroke. ‡ 2024 ESC guidelines to reduce CV mortality, MI, or stroke in chronic coronary syndrome patients with overweight (BMI >27 kg/m2) or obesity and without T2D. BMI, Body Mass Index; CV, Cardiovascular; MACE, Major Adverse Cardiovascular Event; ESC, European Society of Cardiology. T2D, type 2 diabetes.

Abbreviated Prescribing Information Wegovy®t(semaglutide) Please refer to the full Summary of Product Characteristics (SmPC) before prescribing. Wegovy® 0.25 mg FlexTouch® solution for injection in pre-filled pen. Wegovy® 0.5 mg FlexTouch® solution for injection in pre-filled pen. Wegovy® 1 mg FlexTouch® solution for injection in pre-filled pen. Wegovy® 1.7 mg FlexTouch® solution for injection in pre-filled pen. Wegovy® 2.4 mg FlexTouch® solution for injection in pre-filled pen. Indication(s): Adults: Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥30 kg/m2 (Obesity) or ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. For trial results with respect to cardiovascular risk reduction, obesityrelated heart failure, and populations studied, see section 5.1. of the Wegovy® SmPC. Adolescents: Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with obesity* and body weight above 60 kg. Treatment with Wegovy® should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose. *See table 1 in the Wegovy® SmPC for BMI cut-off points for obesity by sex and age. Posology and administration: Administered once weekly at any time of the day, with or without meals. Injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed. It should not be administered intravenously or intramuscularly. Injection sites should always be rotated to reduce the risk of injection site amyloid deposits. The day of weekly administration can be changed if necessary, as long as the time between two doses is at least 3 days (>72 hours). After selecting a new dosing day, once-weekly dosing should be continued. Adults: The maintenance dose of semaglutide 2.4 mg once-weekly is reached by starting with a dose of 0.25 mg. To reduce the likelihood of gastrointestinal symptoms, the dose should be escalated over a 16-week period to the maintenance dose. In case of significant gastrointestinal symptoms, consider delaying dose escalation or lowering to the previous dose until symptoms have improved. Adolescents: For adolescents ages 12 years and above, the same dose escalation schedule as for adults should be applied. The dose should be increased until 2.4 mg (maintenance dose) or maximum tolerated dose has been reached. Weekly doses higher than 2.4 mg are not recommended in the adult and adolescent populations. Patients with type 2 diabetes: When initiating Wegovy®, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia. Missed dose: If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped, and the next dose should be administered on the regularly scheduled day. If more doses are missed, reducing the starting dose for re-initiation should be considered. Elderly: No dose adjustment is required based on age. Renal impairment: No dose adjustment is required for patients with mild or moderate renal impairment. Experience in patients with severe renal impairment is limited. Semaglutide is not recommended for use in patients with severe renal impairment (eGFR <30 mL/min/1.73m2) including patients with end-stage renal disease. Hepatic impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment. Experience in patients with severe hepatic impairment is limited. Semaglutide is not recommended for use in patients with severe hepatic impairment and should be used cautiously in patients with mild or moderate hepatic impairment. Paediatrics: The safety and efficacy of semaglutide in children below 12 years of age have not been established. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation.

Therefore, the increased risk of residual gastric content due to delayed gastric emptying should be considered prior to performing procedures with general anaesthesia or deep sedation. Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions that can cause dehydration, which in rare cases can lead to a deterioration of renal function. Patients should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Wegovy® should be discontinued; if confirmed, Wegovy® should not be restarted. Caution should be exercised in patients with a history of pancreatitis. In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis.

Wegovy® should not be used as a substitute for insulin in patients with type 2 diabetes. Wegovy® should not be used in combination with other GLP-1 receptor agonist products. Patients treated with Wegovy® in combination

with a sulfonylurea or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with a GLP-1 receptor agonist.

In patients with diabetic retinopathy treated with semaglutide, an increased risk of developing diabetic retinopathy complications has been observed. Patients with diabetic retinopathy using semaglutide should be monitored closely and treated according to clinical guidelines. There is no experience with Wegovy® in patients with type 2 diabetes with uncontrolled or potentially unstable diabetic retinopathy. In these patients, treatment with Wegovy® is not recommended. The safety and efficacy of Wegovy® has not been investigated in patients treated with other products for weight management, with type 1 diabetes, with severe renal or hepatic impairment or with congestive heart failure New York Heart Association (NYHA) class IV. Use in these patients is not recommended. There is limited experience with Wegovy® in patients aged 85 years or more, with mild or moderate hepatic impairment, with inflammatory bowel disease or with diabetic gastroparesis. Use with caution in these patients. If semaglutide is used in combination with a sulfonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines. Fertility, pregnancy and lactation: Women of childbearing potential are recommended to use contraception when treated with semaglutide. There are limited data from the use of semaglutide in pregnant women. Therefore, semaglutide should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, semaglutide should be discontinued. Semaglutide should be discontinued at least 2 months before a planned pregnancy due to the long half-life. In lactating rats, semaglutide was excreted in milk. A risk to a breast-fed child cannot be excluded. Semaglutide should not be used during breast-feeding. Effect on fertility unknown. Undesirable effects: Very common (≥1/10): Headache, vomiting, diarrhoea, constipation, nausea, abdominal pain, fatigue.

Common (≥1/100 to <1/10): Hypoglycaemia in patients with type 2 diabetes, dizziness, dysgeusia, dysaesthesia, diabetic retinopathy in patients with type 2 diabetes, gastritis, gastrooesophageal reflux disease, dyspepsia, eructation, flatulence, abdominal distension, cholelithiasis, hair loss, injection site reactions. Uncommon (≥1/1,000 to <1/100): Hypotension, orthostatic hypotension, increased heart rate, acute pancreatitis, delayed gastric emptying, increased amylase, increased lipase. Rare (≥1/10,000 to <1/1,000): Anaphylactic reaction, angioedema.

Not known (cannot be estimated from the available data): Intestinal obstruction. The SmPC should be consulted for a full list of side effects. MA number(s): Wegovy® 0.25 mg FlexTouch® EU/1/21/1608/006. Wegovy® 0.5 mg FlexTouch® EU/1/21/1608/007. Wegovy® 1 mg FlexTouch® EU/1/21/1608/008. Wegovy® 1.7 mg FlexTouch® EU/1/21/1608/009. Wegovy® 2.4 mg FlexTouch® EU/1/21/1608/010. Legal category: Product subject to prescription which may not be renewed. For complete prescribing information please refer to the SmPC which is available on www.medicines.ie or by email from infoireland@novonordisk.com or from the Clinical, Medical and Regulatory Department, Novo Nordisk Limited, 1st Floor, Block A, The Crescent Building, Northwood Business Park, Santry, Dublin 9, Ireland. Date last revised: February 2025. tThis medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Adverse events should be reported to the Health Products Regulatory Authority. Information about adverse event reporting is available at www.hpra.ie. Adverse events should also be reported to Novo Nordisk on Tel: 01 8629700 or complaintireland@novonordisk.com.

References 1. Wegovy® [summary of product characteristics] www.medicines.ie. 2. Rubino D, et al. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes. The STEP 8 Randomized Clinical Trial. JAMA. 2022;327(2):138-150. 3. Garvey WT, et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022;28(10):2083-2091. 4. Lincoff AM, et al. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med. 2023;389(24):2221-2232.

5. Vrints C, et al. ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes: Developed by the task force for the management of chronic coronary syndromes of the European Society of Cardiology (ESC). Endorsed by the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024;45(36):3415–3537. 6. ASOI Adult Obesity Clinical Practice Guideline adaptation (ASOI version 1, 2022) by: Le Roux C W1, Fitzgerald I2, Neff K3. Chapter adapted from: Pedersen SD, Manjoo P, Wharton S. Available from: https:// asoi.info/guidelines/pharmacotherapy/ March 2025, IE25SEMO00022

THE MEDICAL INDEPENDENT | 3 JUNE 2025

3

News

Working conditions impacting on retention of psychiatrists – President PAT KELLY

The retention of consultant psychiatrists remains “a problem” due to poor working conditions, lack of multi-disciplinary teams, and inadequate IT, the President of the College of Psychiatrists of Ireland has told the Medical Independent (MI).

At the College’s recent Spring Conference, Dr Lorcan Martin also voiced strong concerns about underfunding of mental health services and planned legislative changes affecting mental healthcare.

A “huge number” of psychiatry posts are unfilled or tem-

porarily filled, Dr Martin told MI. “We think we will need another few hundred psychiatrists by 2030 to achieve the numbers we need. There are big gaps in the system in terms of getting people. And holding onto them is also a problem because very often, they are in situations where work conditions are poor, they are not adequately resourced, they don’t have a multi-disciplinary team, they don’t have IT resources, they don’t have admin resources, and so on.”

Dr Martin also expressed serious concerns about the

Mental Health Bill 2024 and implications for patients who are involuntarily admitted and do not have capacity to consent to treatment.

The current Bill “will put us in a situation where we will be able to detain patients, but we may not be able to treat them without having to go to court, which would cause significant delays in treating them”.

“Th is of course causes protracted suffering and makes it more difficult for people to become well, because ongoing mental illness can have a neurotoxic effect on the brain and so damages the brain the longer it goes untreated. As with any illness, the ideal approach is to treat it as quickly as possible.” See conference coverage, p36-38.

TARGAXAN® 550 mg (rifaximin-α) twice daily for your adult hepatic encephalopathy patients

Medical Council complaints process ‘emotionally taxing’

At home they are still at risk...

CATHERINE REILLY

The Medical Council’s complaints process has been described by doctors as “emotionally taxing” and “traumatising” during focus group sessions.

Doctor and patient focus groups were established as part of the Council’s Complaints Model Framework project. The fi ndings are contained in a new report, Doctor and patient views on reforming the complaints model.

The Council is examining how to “rebalance” its regulatory model through a “proportionate, risk-based, and agile approach”.

The report stated that the necessity of a formal complaints process for serious cases was “evidently expressed” during the focus groups.

“However, the need to improve the current model was also stark; this was required for the Council, patients, and doctors. A number of themes were generated from the discussions during the focus groups including the complaints process being an emotionally taxing experience, which needs to include support for doctors.”

The need for alternate informal processes prior to the complaints procedure, streamlined processes, improved communication, and increased accountability within the Medical Council, were other “strong” themes.

The prospect of receiving a complaint from the Medical Council elicited a strong emotional response among doctors. One doctor spoke about carrying this as a concern “every day for their career” while others remarked on the “constant fear” of being complained about.

Receiving a complaint had a negative impact on a doctor's mental health. One doctor shared feeling “dehumanised” by the process, another commented on suicide risk, and others spoke about how emotionally traumatising it is to be complained about and to undergo a lengthy investigation.

Supports at varying levels of complexity were suggested by doctors, ranging from better signposting to key workers within the Council, peer support, and counselling services.

Patient feedback also indicated the complaints process was “inadequate and inefficient in many ways”.

The possibility of engaging in mediation as a fi rst step arose as a strong theme. More broadly, patients reported feeling that many doctors were operating “through a paternalistic lens” and were not open to communicating and sharing knowledge.

The Council has since launched CAREhub, an external mental health support service for doctors, medical students, and the public who are engaged with its regulatory processes.

Most complaints investigated by the Medical Council do not result in fitness to practise proceedings.

...TARGAXAN® reduces the recurrence of episodes of overt hepatic encephalopathy in adults.1

REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING Presentation: Each film-coated tablet contains rifaximin 550 mg. Uses: Targaxan is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Dosage and administration: Recommended dose: 550mg twice daily as long term treatment for the reduction in recurrence of episodes of overt hepatic encephalopathy.

In the pivotal study, 91% of patients were using concomitant lactulose. Targaxan is administered orally with a glass of water, with or without food. No dosage changes are necessary in the elderly or those with hepatic insufficiency. Use with caution in patients with renal impairment. The safety and efficacy in paediatric patients (aged less than 18 years) have not been established. Contraindications: Contraindicated in hypersensitivity to rifaximin, rifamycin-derivatives or to any of the excipients and in cases of intestinal obstruction. Warnings and precautions for use: Severe cutaneous adverse reactions (SCAR) including: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported (frequency unknown) in association with rifaximin treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, rifaximin should be withdrawn immediately and an alternative treatment considered (as appropriate). If the patient has developed a serious reaction such as SJS or TEN with the use of rifaximin, treatment with rifaximin must not be restarted in this patient at any time. The potential association of rifaximin treatment with Clostridium difficile associated diarrhoea and pseudomembranous colitis cannot be ruled out. The concomitant administration of rifaximin with other rifamycins is not recommended. Patients should be informed that rifaximin may cause a reddish discolouration of the urine. Use with caution in patients with severe (Child-Pugh C) hepatic impairment and in patients with MELD (Model for End-Stage Liver Disease) score > 25. Caution should be exercised when concomitant use of rifaximin and a P-glycoprotein inhibitor such as ciclosporin

is needed. Both decreases and increases in international normalized ratio (in some cases with bleeding events) have been reported in patients maintained on warfarin and prescribed rifaximin. If co-administration is necessary, the international normalized ratio should be carefully monitored with the addition or withdrawal of treatment with rifaximin.

Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Interactions: In patients with hepatic impairment, rifaximin may decrease the exposure of concomitantly administered CYP3A4 substrates (e.g. warfarin, antiepileptics, antiarrhythmics, oral contraceptives). Pregnancy, lactation and fertility: Rifaximin is not recommended during pregnancy. A decision must be made whether to discontinue breast-feeding or to discontinue/ abstain from rifaximin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Animal studies do not indicate direct or indirect harmful effects with respect to male and female fertility.

Undesirable effects: Common adverse reactions (≥1/100 to <1/10) are: depression, dizziness, headache, dyspnoea, upper abdominal pain, abdominal distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle spasms, arthralgia and peripheral oedema. Other less frequently reported adverse reactions are: Clostridial infections, urinary tract infections, candidiasis, pneumonia, cellulitis, upper respiratory tract infection, rhinitis, anaemia, thrombocytopenia, anaphylactic reactions, angioedemas, hypersensitivity, anorexia, hyperkalaemia, dehydration, confusional state, anxiety, hypersomnia, insomnia, balance disorders, amnesia, convulsion, attention disorder, hypoesthesia, memory impairment, hot flush, hypertension, hypotension, presyncope, syncope, pleural effusion, chronic obstructive pulmonary disease, abdominal pain, oesophageal varices haemorrhage, dry mouth, stomach discomfort, constipation, liver function test abnormalities, SJS, TEN, dermatitis, eczema, myalgia, back pain, dysuria, pollakiuria, proteinuria, oedema, pyrexia, asthenia, International normalised ratio abnormalities, fall, contusions, procedural pain. Prescribers should consult the SmPC in relation to other adverse reactions.

Legal category: Prescription only Marketing Authorisation holder: Norgine B.V. Antonio Vivaldistraat 150, 1083 HP, Amsterdam, Netherlands Marketing Authorisation number: PA 1336/009/001 For further information contact: Telephone: +44 (0)1895 826 606 E-mail: medinfo@norgine.com Ref: IE-HEP-XIF-2400015 Date of revision: Dec 2024

Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance. Website: www.hpra.ie. Adverse events should also be reported to Medical Information at Norgine Ltd on: Tel: +44 (0)1895 826 606 Email: medinfo@norgine.com

References: 1. TARGAXAN® 550 Summary of Product Characteristics.

Available for Ireland from: www.medicines.ie.

Product under licence from Alfasigma S.p.A. TARGAXAN® is a registered trademark of the Alfasigma group of companies, licensed to the Norgine group of companies. NORGINE and the sail logo are registered trademarks of the Norgine group of companies.

IE-HEP-RIF-2500005 Date of preparation: March 2025

THE MEDICAL INDEPENDENT | 3 JUNE 2025

4

News Feature DAVID LYNCH david@mindo.ie

‘Significant headwinds’ in doctor recruitment and retention Two new reports describe the growth in the numbers of consultants and trainees, but also warn of challenges ahead, writes David Lynch

A

cross a combined 168 pages of detailed statistics and data analysis, two new reports from HSE National Doctors Training and Planning (NDTP) outline the state of doctor recruitment and retention in Ireland.

While the Medical Workforce Analysis Report 2024-2025 and Medical Recruitment and Retention Report 2024 are densely packed with facts and figures, some trends are clearly discernible.

Most significantly, workforce numbers are rising.

In his introduction to the analysis report, NDTP Medical Director Prof Anthony O’Regan writes that the number of consultants employed by the HSE has “increased dramatically” since 2018 – from 3,089 to 4,620 in 2024.

The number of consultants per 100,000 also increased from 63.8 to 86.3 over the same period. While this expansion is to be welcomed, Prof O’Regan cautioned that the figures remain below comparable countries.

The data also fi nds the number of doctors in postgraduate medical training has continued its recent rise. In 2024, the figure was 5,681, up from 5,435 in 2023.

There have also been “substantial improvements” in the retention of doctors post-certificate of satisfactory completion of specialist training (CSCST).

Of the doctors who completed higher specialist training (HST) in 2019, some 78 per cent were working in Ireland in either a public or private post in 2023. Th is figure rose to 82 per cent in 2024, However, despite some encouraging data, Prof O’Regan has also raised concerns.

Prof O’Regan, Consultant in Respiratory and Internal Medicine at University Hospital Galway, warned of “significant headwinds to recruitment and retention”.

These included the recent fall-off in the number of new consultant posts approved by the consultant applications advisory committee (CAAC).

Th is decline will likely “impact” the retention of HST specialist trainees “in the short- and medium-term”. In addition, the barriers to attracting doctors to work in model 3 hospitals may also result in “reduced retention rates”.

While consultant numbers are rising, there is still considerable workforce demand in the system, according to Mr Tom Pierse, Medical Workforce Analytics Lead, NDTP. Mr Pierse was speaking at an NDTP webinar last month. He pointed to recently published NDTP specialty specific reviews,

which focused on surgery, emergency medicine, and the dual-training specialty of medicine and clinical genetics.

“These reports are saying that there are still substantial demands at a specialty level,” Mr Pierse told attendees.

“When you add those together, there is going to be a need for much more growth in the consultant workforce, both at an absolute value and per capita level.”

A “key challenge” for the health service is creating “a long-term plan” to grow consultant staffi ng, along with the broader health workforce that needs to expand in parallel.

Ms Aimée Maguire, Data Analyst, HSE Medical Workforce Planning, showed how between 2018 and 2024 there was a significant growth in consultant numbers. She noted “substantial increases” in the number of new posts approved by the CAAC between 2021 and 2023.

“These increases were seen as... a positive step in being able to expand the consultant workforce,” she told the webinar.

However, as reported in the Medical Independent (MI) in April, there was a 36 per cent fall in the number of consultant posts processed by the HSE last year, according to the CAAC Annual Report 2024.

The HSE’s consultant division processed 347 applications in 2024, which represented a reduction of 194 applications compared to 2023.

Ms Maguire pointed out the amount of

Credit: iStock.com

consultant posts processed fell to “pre2021 numbers”.

“So, I suppose, it will be important to monitor how this will affect the consultant workforce growth in the future and how it will affect the retention of consultants and post-CSCTs in the future as well.”

HDRM project While workforce and training numbers rise, representative bodies and academic researchers continue to shine a light on recruitment and retention difficulties.

The hospital doctor retention and motivation (HDRM) project, which published considerable data in recent years, came to an end in December 2024.

Dr Niamh Humphries (PhD), who worked on the project, noted that when the HDRM began in 2017/2018, 300 Irish doctors obtained Australian work visas.

In comparison, 624 Irish doctors had obtained Australian work visas in 2023/2024.

“I would say there’s still work to be done to better understand emigration, its impact on the Irish health system and how to retain doctors and reduce that level of turnover,” said Dr Humphries, Senior Lecturer, RCSI Graduate School of Healthcare Management.

Ireland will fi nd it “difficult, if not impossible” to achieve a self-sufficient medical workforce if it continues to lose so many doctors to emigration. Dr Humphries defi ned a self-sufficient workforce as one where enough doctors are trained and retained to deliver healthcare to an ageing population.

She said the HDRM project generated “huge insights” into how hospital doctors feel about work and how their conditions could be improved. The research found

What a difference a contract makes The public-only consultant contract (POCC) was introduced in 2023. What impact has it had on recruitment and retention?

Asked this question by the Medical Independent (MI) at the recent webinar, Mr Tom Pierse, Medical Workforce Analytics Lead, HSE National Doctors Training and Planning (NDTP), said this specific detail is not contained in the new data. However, some increases in retention noted in recent NDTP reports were due to a “number of factors... and the [POCC] would be one of those”.

Additionally, the Medical Workforce Analysis Report 2024-2025 provides data on the popularity of the POCC among specific specialties.

Approximately 55 per cent of HSE consultants held the POCC at the end last year, which has since increased

to over 62 per cent. However, there continues to be a “wide variation” in the proportion of consultants in each medical discipline who have chosen to avail of this contract.

The specialties with the highest percentage uptake of the contract are: Anaesthesiology and intensive care medicine (66 per cent); pathology (64 per cent); radiology (58 per cent); and general medicine (57 per cent).

Next are emergency medicine (54 per cent); paediatrics (54 per cent); and surgery (49 per cent). Psychiatry has a 41 per cent uptake, while obstetrics and gynaecology has just 37 per cent.

Some 92 per cent of permanent consultants under 35 years old hold the POCC. The lowest uptake among permanent consultants is in the 50-54 age group.

At a recent psychiatry symposium, hosted by the IHCA, several speakers highlighted ongoing recruitment and retention challenges affecting nursing and other members of multidisciplinary teams.

However, Dr Donal O’Hanlon, Consultant Psychiatrist and former IHCA President, told MI that while he believed there “will always be some issues around recruitment and retention” across specialties, “there has been an improvement” in relation to consultant psychiatrists. He added that this has been “very valuable”.

Asked if the POCC was the principal reason for this upturn, Dr O’Hanlon replied it was “hard to say”.

“But I suspect the new contract has been important in people’s decision-making.”

THE MEDICAL INDEPENDENT | 3 JUNE 2025

5

Feature News

Divergent migration patterns for GPs The Medical Recruitment and Retention Report 2024 documents the proportion of Irish-trained GPs working in general practice in Ireland. The report was prepared by HSE National Doctors Training and Planning in collaboration with the Medical Council.

The proportion of GPs who trained in Ireland who are on the Medical Council register is 96 per cent. While a percentage of these may not be clinically active or out of the country, “it suggests a different pattern of migration” to other specialties. The report also shows that 84 per cent of Irish-trained GPs were working in the specialty of general practice. A small percentage had gone

that Ireland’s hospital doctors endure difficult working conditions, long working hours, and a heavy workload. Doctors described working in an overstretched, understaffed health system leading to stress, exhaustion, and burnout among staff members.

Dr Humphries believes the HDRM succeeded in voicing the concerns of the medical workforce and generating debate on these issues.

“In terms of the policy response, I’m not sure that the health system has been as responsive as it needs to be,” she told MI. “I think that improved working conditions for hospital doctors are the key to improving doctor retention and doctor wellbeing and it would be good to see a greater policy focus on these important topics.”

IHCA In response to the two new NDTP reports, the IHCA has also raised concerns over the “considerable drop” in the new and replacement consultant posts approved by the CAAC. The Association warned that this “dramatic fall” is likely to deepen in 2025, potentially undermining both the retention of qualified specialists and efforts to expand the workforce in line with rising demand.

IHCA President Prof Gabrielle Colleran welcomed the appointment of additional consultants in recent years. However, she said Ireland was “still has the lowest number of medical specialists per 1,000 population in the EU, approximately one-third below the European average”.

“Addressing this specialist workforce deficit, in parallel with rapidly increasing the number of hospital beds, theatres, diagnostic and other facilities, will start the health service on its journey towards a better and more productive future.”

The recruitment difficulties for the model 3 hospital sector have been a particular focus for NDTP. These were highlighted in the Model 3 Hospitals Report published in late 2023.

However, speaking at the recent webinar, Ms Maguire outlined that model 3 hospitals witnessed an 11 per cent growth in the number of consultants in 2024, compared to an 8 per cent growth in

into other clinical roles.

Further data on GP retention will be available in the coming years following ongoing research.

Funded by a Health Research Board applied partnership award, in collaboration with the Irish College of GPs, the GP Retention Project is undertaking data collection with GPs who work in Ireland and Irish-trained GPs based abroad.

The project is “going really well”, RCSI Lecturer Dr Niamh Humphries (PhD) told the Medical Independent.

The Lead Researcher, Dr Holly Hanlon (PhD), RCSI, is in the process of collecting qualitative data from

model 4 hospitals. In absolute terms, more consultants were added to model 4 hospitals (172) than to model 3 hospitals (104).

Ms Maguire said the model 3 increase “suggests a large recruitment drive”. However, she added that a recent NDTP survey showed that NCHDs were less likely to take up posts at such hospitals.

In the new workforce analysis report, Prof O’Regan writes that notwithstanding the “substantial increases” in the con-

20 GPs working in Ireland. It is hoped to complete data collection and begin sharing results before the end of the year.

“We’re also hoping to interview Irishtrained GPs now living and working abroad. Recruitment for that component of the project is ongoing. We’re hoping that we can connect with emigrant Irishtrained GPs to find out why they left and what might encourage them to return.”

If you are an Irish GP abroad who would like to take part, contact the project at https://doctorretention.eu/ project-invitation/

sultant workforce in model 3 hospitals, “significant challenges” remain. These include high rates of temporary employment of consultants (23 per cent) and an older demographic of consultants (37 per cent over 55 years old).

The new NDTP reports are available here: www.hse.ie/eng/staff/leadershipeducation-development/met/

Is it time for a new permanent grade?

According to the Medical Workforce Analysis Report 2024-2025, the number of doctors in postgraduate medical training has been increasing over recent years. In 2024, the number of doctors in training was 5,681, which was an increase from 5,435 in 2023.

In 2024, 42 per cent of NCHDs were in non-training posts. The number of these non-training scheme doctors (NTSDs) “continues to expand”.

Between 2023 and 2024, there was an 11 per cent increase.

Writing in the report, HSE National Doctors Training and Planning (NDTP) Medical Director Prof Anthony O’Regan states that some medical disciplines, such as emergency medicine, have “particularly high proportions” of NTSDs to consultants.

Data also shows a low retention rate of this cohort in the HSE. Addressing a recent NDTP webinar, Prof O’Regan acknowledged the number of NTSDs is “growing year on year”. However, he stressed that this growth was not due to a lack of expansion in training places.

“We’ve to acknowledge that a lot of work has been done with the postgraduate training bodies to increase training posts. The difficulty is that the NCHD workforce, as a whole, is growing at a greater rate than the expansion of training numbers.”

Gaining a better understanding

of the needs and career journeys of NTSDs will be a particular focus for NDTP in the coming years, he said.

In response to the rising number of NTSDs, Prof O’Regan suggested that the health service consider introducing a new permanent nontraining doctor grade, similar to models in place in other jurisdictions.

He noted such a grade “might be attractive to all graduates”.

In response to a query from this newspaper, the Department of Health noted that the NCHD taskforce report recommended the examination of the feasibility and potential benefits to the health service of formally establishing a new permanent doctor grade.

This recommendation will be considered “over the coming months”, the spokesperson told the Medical Independent.

Writing in the Medical Recruitment and Retention Report 2024, Prof O’Regan noted “two distinct groups” of NTSDs: Those on a gap year between training programmes and those that do not go on to further training.

“The analysis shows that on average 64 per cent of new nontraining scheme doctors do not go on to further training with many leaving the health system after a few years and only a small proportion remaining in the Irish health system for longer than five years.”

MINDO NUMBERS

24%

of post-primary students in Ireland have tried smoking, according to the latest European School Survey Project on Alcohol and Other Drugs (ESPAD) Report.

12%

are current smokers, and 2 per cent smoke daily, the ESPAD Report found.

32%

have tried e-cigarettes, with 16 per cent reporting they are current users.

3

new national clinical guidelines for breast, prostate, and rectal cancer – the most common cancers in Ireland – have been published by the National Cancer Control Programme.

2,000

blood donations were urgently needed over a four-week period to maintain the national supply, the Irish Blood Transfusion Service stated on 21 May.

60%

of people in Ireland with Crohn’s disease and colitis experience financial hardship due to their condition, according to new research from Crohn’s and Colitis Ireland.

THE MEDICAL INDEPENDENT | 3 JUNE 2025

6

News

CUH centre to advance provision of stem cell and cellular therapies NIAMH CAHILL

The HSE is planning a new multi-million euro unit at Cork University Hospital (CUH) as part of efforts to improve cancer services in the region, the Medical Independent (MI) has learned.

A new €27 million stem cell tissue establishment and aseptic compounding unit (ACU) is part of the hospital’s plan to become “the leading comprehensive cancer centre in the country”, a spokesperson for HSE South West told MI. The aim is to improve access and outcomes in medical oncology as demand continues to rise, they stated.

According to a tender notice seeking providers to assist in the design and construction of the unit, CUH was “not providing optimal treatment” in respect of stem cell treatment (SCT) and cellular

therapies (CAR-T), with patients requiring transfer to other parts of the country.

In 2024, a project team was established to progress the construction of the co-located, purpose-built unit. The unit is projected to take up to four years to complete.

“A tissue establishment in CUH would facilitate on-site stem cell procurement and transplantation for our patients, without unnecessary travel or delays and associated potential risk of disease relapse. It would allow HSE South West and CUH to provide optimal treatment in respect of SCT and CAR-T,” the spokesperson said.

The spokesperson listed several benefits associated with the project, including increased capacity in line with National Cancer Registry Ireland projections; enhanced activity and value for money by reducing outsourcing of chemotherapy

services; and expansion of clinical trials and more specialised advanced therapy medicinal products trials.

The proposed ACU will provide “a superior aseptic compounding service”. It will enable operational flexibility (same day dose/regimen adjustment and compliance with National Cancer Control Programme time-to-treatment key performance indicators), avoidance of waste/ excess costs, and production savings, the spokesperson added.

Autologous stem cell transplant (ASCT) and allogeneic stem cell transplant (allo-SCT) are well established therapies for blood cancers.

“With current ongoing trials it might find its indications for other types of non-haematological tumours. Administration of any of these treatments is only possible in sites that have an authorised

DPENDR raises concerns over ‘complexity’ of HSE governance structure

Pictured are Consultant Oncologist Dr Raheel Khan and Oncology Advanced Nurse Practitioner Ms Patrice Kearney Sheehan.

In 2022, Dr Khan and Ms Kearney Sheehan established a clinic at Tallaght University Hospital to screen men for potential health complications following a history of testicular cancer.

Dr Khan (now at St James’s Hospital) and Ms Kearney Sheehan are among the authors of a new paper in Supportive Care in Cancer, which provides a description of common late side-effects in testicular cancer survivors and a care pathway through a nurse-led specialised clinic.

DAVID LYNCH

Officials from the Department of Public Expenditure, NDP Delivery and Reform (DPENDR) raised concerns over the “complexity” of the HSE’s governance structure.

The discussion arose at the health budget oversight group (HBOG) meeting in December. The HSE, the Department of Health, and DPENDR are members of the HBOG. According to meeting minutes, a presentation was delivered by DPENDR on the area of governance. The presentation focused on the “key principles” of good governance in line with international best practice, whilst also presenting an understanding of the existing governance structure within the HSE. Following the presentation, a discussion took place on what the DPENDR referred to as the “complexity of the governance structure” within the HSE. The DPENDR noted that the existing structure has several layers. “This could negatively affect the communication of targets to hospital managers as well as the escalation processes in the HSE.” This discussion occurred in the context of the creation of six health regions, which have replaced hospital groups and community healthcare organisations. This process began in March 2024. The HSE is still a single organisation, but with six regions. The HSE continues to be responsible for standards and guidelines. However, each region has its own budget, leadership team, and responsibility for local decision-making.

According to the HBOG meeting minutes, the HSE said it expected that the new regionalised structure would have “a positive impact on transparency and accountability”, with the six regional executive officers (REOs) sitting on a senior leadership team led by the HSE CEO. “Each REO will be held to account in line with the terms of a signed performance agreement between them and the CEO.” A comment on DPENDR’s concerns was awaited from the HSE at press time.

tissue establishment. Currently, patients from this region are transplanted in St James’s Hospital and University Hospital Galway.

“The main indications for ASCT include multiple myeloma (approximately 80 per cent of all ASCT in CUH) and lymphomas; however, ASCT can also be used for other blood disorders, and non-haematological conditions such as multiple sclerosis.

“The incidence of multiple myeloma has increased by 32 per cent since the early 1990s. On the other hand, the number of ASCT performed for CUH patients has increased from six to seven per year in 2012-2015 to 20 to 30 per year in recent years. As the age of patients undergoing transplant has also increased, it is evident now and going forward that the demand for the service will increase.”

Regulatory requirements impacting consultant workplans DAVID LYNCH

Consultants have called on the HSE to conduct an analysis of the time they spend engaging in mandatory training and regulatory requirements.

At the IMO AGM in April, a motion was passed by the national consultant committee calling for an analysis to ensure this time “is factored into consultant productivity and workforce management”.

Pressures on consultant rostering and workplans featured prominently during the consultant meeting.

Dr Mick Molloy, Consultant in Emergency Medicine, told the meeting that the amount of mandatory training “is significant” for new doctors.

“They arrive in a hospital and the first thing they are given is this list of mandatory things they have to do… and they are thinking ‘how am I going to do all this?’, especially if they are straight into the emergency department or on-call rota.…”

Speaking to the Medical Independent prior to the consultant meeting, Chair of the IMO consultant committee Prof Matthew Sadlier said there are challenges associated with the volume of online training required of doctors and other staff.

These challenges include the impact on overall hospital activity.

He added that doctors support the need for continuing professional development and it can be “one of the more enjoyable parts of the job in many ways”.

“But it’s just as important that rosters take [the amount of time] into consideration,” he said.

Separately, a proposal for a voluntary exit interview for consultants has the potential to “make a difference” in improving recruitment and retention, Prof Sadlier said.

The consultant committee passed a motion calling for such an interview process, with thematic outcomes to be published annually.

TREAT the HEAT

WITH NON-HORMONAL VEOZA VEOZA (fezolinetant) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 1 VMS are also known as hot flushes and night sweats. 2 First-in-class selective neurokinin 3 (NK3) receptor antagonist to be licensed1,3

Evaluated for safety over 52 weeks1

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

Once-daily oral dosing with VEOZA 45 mg 1

Drug-induced liver injury (DILI) has been reported; perform liver function tests (LFTs) before treatment, monthly for the first 3 months, then based on clinical judgement.

Treatment should not be started if ALT or AST is ≥ 2 x ULN or if total bilirubin is elevated (e.g., ≥ 2 x ULN).

Discontinue if ALT/AST > 5 x ULN OR ALT ≥ 3 x ULN with: total bilirubin > 2 x ULN OR symptoms of liver injury.

Contraindications include hypersensitivity to ingredients, concomitant use with moderate/strong CYP1A2 inhibitors, and known or suspected pregnancy.

Common undesirable effects include diarrhoea (3.2%) and insomnia (3.0%). Refer to the SmPC for full prescribing details.1

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare

professionals are asked to report any suspected adverse reactions. See section 4.8 of the SPC for how to report adverse reactions.

NK3: neurokinin 3, VMS: vasomotor symptoms.

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

ABBREVIATED SUMMARY OF PRODUCT CHARACTERISTICS For full prescribing information refer to the Summary of Product Characteristics (SPC).

▼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. NAME OF THE MEDICINAL PRODUCT: Veoza 45 mg film-coated tablets QUALITATIVE AND QUANTITATIVE COMPOSITION: Each film-coated tablet contains 45 mg of fezolinetant. For the full list of excipients, see section 6.1 of the SPC. PHARMACEUTICAL FORM: Film-coated tablet (tablet). Round, light red tablets (approximately 7 mm diameter × 3 mm thickness), debossed with the company logo and ‘645’ on the same side. CLINICAL PARTICULARS: Therapeutic indications: Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause (see section 5.1 of the SPC). Posology and method of administration: The recommended dose is 45 mg once daily. Benefit of long-term treatment should be periodically assessed since the duration of VMS can vary by individual. Missed dose: If a dose of Veoza is missed or not taken at the usual time, the missed dose should be taken as soon as possible, unless there is less than 12 hours before the next scheduled dose. Individuals should return to the regular schedule the following day. Elderly: Fezolinetant has not been studied for safety and efficacy in women initiating Veoza treatment over 65 years of age. No dose recommendation can be made for this population. Hepatic impairment: No dose modification is recommended for individuals with Child-Pugh Class A (mild) chronic hepatic impairment (see section 5.2 of the SPC). Veoza is not recommended for use in individuals with Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment. Fezolinetant has not been studied in individuals with Child-Pugh Class C (severe) chronic hepatic impairment (see section 5.2 of the SPC). Renal impairment: No dose modification is recommended for individuals with mild (eGFR 60 to less than 90 ml/min/1.73 m2) or moderate (eGFR 30 to less than 60 ml/min/1.73 m2) renal impairment (see section 5.2 of the SPC).

Veoza is not recommended for use in individuals with severe (eGFR less than 30 ml/min/1.73 m2) renal impairment. Fezolinetant has not been studied in individuals with end-stage renal disease (eGFR less than 15 ml/min/1.73 m2) and is not recommended for use in this population (see section 5.2 of the SPC). Paediatric population: There is no relevant use of Veoza in the paediatric population for the indication of moderate to severe VMS associated with menopause. Method of administration: Veoza should be administered orally once daily at about the same time each day with or without food and taken with liquids. Tablets are to be swallowed whole and not broken, crushed, or chewed due to the absence of clinical data under these conditions. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SPC. Concomitant use of moderate or strong CYP1A2 inhibitors (see section 4.5 of the SPC). Known or suspected pregnancy (see section 4.6 of the SPC). Special warnings and precautions for use: Medical examination/consultation: Prior to the initiation or reinstitution of Veoza, a careful diagnosis should be made, and complete medical history (including family history) must be taken.

During treatment, periodic check-ups must be carried out according to standard clinical practice.

Liver disease: Veoza is not recommended for use in individuals with Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment. Women with active liver disease or Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment have not been included in the clinical efficacy and safety studies with fezolinetant (see section 4.2 of the SPC) and this information cannot be reliably extrapolated. The pharmacokinetics of fezolinetant has been studied in women with Child-Pugh Class A (mild) and B (moderate) chronic hepatic impairment (see section 5.2 of the SPC).

Drug-induced liver injury (DILI): Elevations in serum alanine aminotransferase (ALT) levels and serum aspartate aminotransferase (AST) at least 3 times the upper limit of normal (ULN) were observed in women treated with fezolinetant, including serious cases with increased total bilirubin and symptoms suggesting liver injury. Elevated liver function tests (LFTs) and symptoms suggestive of liver injury were generally reversible on discontinuation of therapy. LFTs must be performed prior to treatment initiation with fezolinetant. Treatment should not be started if ALT or AST is ≥ 2 x ULN or if total bilirubin is elevated (e.g., ≥ 2 x ULN). LFTs must be performed monthly during the first three months of treatment, then based on clinical judgement. LFTs must also be performed

when symptoms suggestive of liver injury occur. Treatment should be discontinued in the following situations: - Transaminase elevations are ≥ 3 x ULN with: total bilirubin > 2 x ULN OR symptoms of liver injury. - Transaminase elevations > 5 x ULN. Monitoring of liver function should be maintained until they have normalised. Patients should be informed about the signs and symptoms of liver injury and should be advised to contact their doctor immediately once these occur. Known or previous breast cancer or oestrogen-dependent malignancies: Women undergoing oncologic treatment (e.g., chemotherapy, radiation therapy, anti-hormone therapy) for breast cancer or other oestrogen-dependent malignancies have not been included in the clinical studies. Therefore, Veoza is not recommended for use in this population as the safety and efficacy are unknown.

Women with previous breast cancer or other oestrogen-dependent malignancies and no longer on any oncologic treatment have not been included in the clinical studies. A decision to treat these women with Veoza should be based on a benefit-risk consideration for the individual. Concomitant use of hormone replacement therapy with oestrogens (local vaginal preparations excluded): Concomitant use of fezolinetant and hormone replacement therapy with oestrogens has not been studied, and therefore concomitant use is not recommended. Seizures or other convulsive disorders: Fezolinetant has not been studied in women with a history of seizures or other convulsive disorders. There were no cases of seizures or convulsive disorders during clinical studies. A decision to treat these women with Veoza should be based on a benefit-risk consideration for the individual. Interactions: Effect of other medicinal products on fezolinetant: CYP1A2 inhibitors: Fezolinetant is primarily metabolised by CYP1A2 and to a lesser extent by CYP2C9 and CYP2C19. Concomitant use of fezolinetant with medicinal products that are moderate or strong inhibitors of CYP1A2 (e.g., ethinyl oestradiol containing contraceptives, mexiletine, enoxacin, fluvoxamine) increase the plasma Cmax and AUC of fezolinetant. Concomitant use of moderate or strong CYP1A2 inhibitors with Veoza is contraindicated (see section 4.3 of the SPC).

Co-administration with fluvoxamine, a strong CYP1A2 inhibitor, resulted in an overall 1.8-fold increase in fezolinetant Cmax and 9.4-fold increase in AUC; no change in tmax was observed. Given the large effect of a strong CYP1A2 inhibitor and supportive modelling, the increase in fezolinetant concentrations is expected to be of clinical concern also following concomitant use with moderate CYP1A2 inhibitors (see section 4.3 of the SPC). The increase in fezolinetant exposure was however not predicted to be clinically relevant following concomitant use with weak CYP1A2 inhibitors.

CYP1A2 inducers: In vivo data: Smoking (moderate inducer of CYP1A2) decreased fezolinetant Cmax to a geometric LS mean ratio of 71.74%, while AUC decreased to a geometric LS mean ratio of 48.29%. The efficacy data did not point to relevant differences between smokers and non-smokers.

No dose modification is recommended for smokers. Transporters: In vitro data: Fezolinetant is not a substrate of P-glycoprotein (P-gp). Major metabolite ES259564 is a substrate of P-gp. Effect of fezolinetant on other medicinal products: Cytochrome P450 (CYP) enzymes: In vitro data: Fezolinetant and ES259564 are not inhibitors of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. Fezolinetant and ES259564 are not inducers of CYP1A2, CYP2B6, and CYP3A4. Transporters: In vitro data: Fezolinetant and ES259564 are not inhibitors of P-gp, BCRP, OATP1B1, OATP1B3, OCT2, MATE1, and MATE2-K (IC50 > 70 µmol/l). Fezolinetant inhibited OAT1 and OAT3 with IC50 values of 18.9 µmol/l (30 × Cmax,u) and 27.5 µmol/l (44 × Cmax,u), respectively.

ES259564 does not inhibit OAT1 and OAT3 (IC50 > 70 µmol/l). Undesirable effects: Summary of the safety profile: The most frequent adverse reactions with fezolinetant 45 mg were diarrhoea (3.2%) and insomnia (3.0%). There were no serious adverse reactions reported at an incidence greater than 1% across the total study population. On fezolinetant 45 mg, four serious adverse reactions were reported. The most serious adverse reaction was an event of endometrial adenocarcinoma (0.1%). The most frequent adverse reactions leading to dose discontinuation with fezolinetant 45 mg were alanine aminotransferase (ALT) increased (0.3%) and insomnia (0.2%). Tabulated list of adverse reactions: The safety of fezolinetant has been studied in 2203 women with VMS associated with menopause receiving fezolinetant once daily in phase 3 clinical studies. Adverse reactions observed during clinical studies and from spontaneous reporting are listed below by frequency category in each system organ class. Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); and not known (cannot be estimated from the available data).

Table 1. Adverse reactions for fezolinetant 45 mg MedDRA system organ class (SOC)

Frequency category

Adverse reaction

Psychiatric disorders

Common

Insomnia

Gastrointestinal disorders

Common

Diarrhoea, Abdominal pain

Hepatobiliary disorders

Common

Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased*

Not known

Drug-induced liver injury (DILI)*

*see Description of selected adverse reactions Description of selected adverse reactions: ALT increased/AST increased/DILI: In clinical trials, elevations in ALT levels > 3 x ULN occurred in 2.1% of women receiving fezolinetant compared to 0.8% of women receiving placebo. Elevations in AST levels > 3 x ULN occurred in 1.0% of women receiving fezolinetant compared to 0.4% of women receiving placebo. Serious cases with elevations of ALT and/or AST (> 10 x ULN) with concurrent elevations in bilirubin and/or alkaline phosphatase (ALP) were reported post-marketing. In some cases, elevated liver function tests were associated with signs and symptoms suggestive of liver injury such as fatigue, pruritus, jaundice, dark urine, pale faeces, nausea, vomiting, decreased appetite, and/or abdominal pain (see section 4.4 of the SPC). Overdose: Doses of fezolinetant up to 900 mg have been tested in clinical studies in healthy women. At 900 mg, headache, nausea, and paraesthesia were observed. In the case of overdose, the individual should be closely monitored, and supportive treatment should be considered based on signs and symptoms. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. België/Belgique: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten / Agence fédérale des médicaments et des produits de santé; www.fagg.be / www.afmps.be; Afdeling Vigilantie / Division Vigilance: Website/Site internet: www.eenbijwerkingmelden.be / www.notifieruneffetindesirable.be; e-mail: adr@fagg-afmps.be Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie or Astellas Pharma Co. Ltd. Tel: +353 1 467 1555, E-mail: irishdrugsafety@astellas.com. Nederland: Nederlands Bijwerkingen Centrum Lareb; Website: www.lareb.nl Luxembourg/Luxemburg: Centre Régional de Pharmacovigilance de Nancy ou Division de la pharmacie et des médicaments de la Direction de la santé; Site internet: www.guichet.lu/pharmacovigilance MARKETING AUTHORISATION HOLDER: Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, The Netherlands MARKETING AUTHORISATION NUMBERS: EU/1/23/1771/001-004 DATE OF REVISION OF THE TEXT: February 2025 Job Bag Number: MAT-IE-VEO-2025-00015 Detailed information on this medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu. Ireland: Astellas Pharma Co. Ltd., Tel.: +353 1 467 1555. SPC may be found at www.medicines.ie. Delivery Status: subject to medical prescription. Astellas Pharma B.V., NL: Sylviusweg 62, 2333BE Leiden, Netherlands BE/LU: Medialaan 50, 1800 Vilvoorde, Belgium IE: Legal classification: POM/S1A.

MAT-IE-VEO-2025-00052.

May 2025.

THE MEDICAL INDEPENDENT | 3 JUNE 2025

8

News

Critical care units have ‘significant’ gaps in HSCP and pharmacy workforce CATHERINE REILLY

Critical care units are experiencing considerable deficits in their health and social care professional (HSCP) and pharmacy workforce.

Many of the units nationally have no access to medical social workers, occupational therapists or psychologists, found the report by Ms Aine Kelly, HSE National HSCP Lead for Critical Care.

Seven profession-specific surveys were distributed to the 26 adult critical care units nationally.

According to the responses, 100 per cent of units had input from dietetics and

speech and language therapy, 96 per cent from physiotherapy, and 88 per cent from pharmacy. However, only 58 per cent had access to occupational therapy, 52 per cent to medical social work, and 18 per cent to psychology.

All of the professions had workforce gaps when compared to national and international workforce standards.

“Barriers to closing workforce gaps are multifactorial and span from generic profession-related barriers to critical care specific barriers,” stated the report.

It noted that the HSE Model of Care for Adult Critical Care (2014) set out minimum national standards for the medical

‘Small proportion’ of GP bloods outsourced – LUH CATHERINE REILLY

Letterkenny University Hospital (LUH) is outsourcing the testing of some GP blood samples due to lack of processing capacity.

A spokesperson for HSE West and North West told the Medical Independent: “The Pathology Department at LUH has experienced a significant increase in workload and no longer has the capacity to perform all GP samples in the routine 8am to 8pm window. The only solution to this problem is additional analysers and currently LUH has no floor space to accommodate.”

The spokesperson said a “small proportion” (5.5 per cent) of GP blood sciences testing is being outsourced.

“LUH continues to try to resolve the LUH blood sciences laboratory capacity issue with HSE Pro-

curement. Discussions are taking place to progress an arrangement to provide a turn-key solution to deliver a second track on the blood sciences laboratory, including modular accommodation.”

The outsourcing of blood sciences testing has been discussed at LUH management team meetings, according to minutes obtained under Freedom of Information law.

In April 2024, the meeting heard that “blood science work [is] being outsourced at a significant cost”.

In June 2024, the meeting minutes noted that the outsourcing of these samples was leading to “gaps in laboratory records of some patients as these results are not available to LIS [laboratory information system]”.

The spokesperson for HSE West and North West did not comment on the cost of outsourcing or reconciling results onto the LIS.

and non-medical workforce (which included five HSCP professions and pharmacy).

“Unfortunately, unlike medical and nursing colleagues, no critical care workforce plan or training programme exists to align with this national document,” stated the report, which was completed in 2024.

The report made seven key recommendations to support the development of a HSCP and pharmacy workforce plan in critical care. These included the revision of 2014 national workforce standards to bring them in line with international standards and ensuring adequate investment in HSCP and pharmacy staffing by healthcare providers.

A number of recommendations related

to education and training, including increasing undergraduate numbers and the development of critical care rotations for junior staff. In addition, it recommended a “career pathway review” for HSCP and pharmacy to ensure staff retention.

A HSE spokesperson told the Medical Independent the report was presented and shared with the Department of Health, HSE health regions, and senior hospital stakeholders.

“Its findings will be used to inform and support decision-making and workforce planning in line with the implementation of the critical care strategy, as additional critical care beds are brought onstream.”

HSE seeks providers to tackle lengthy waiting lists for audiology care NIAMH CAHILL

The HSE has issued a tender notice seeking providers to help reduce long waiting lists for community-based audiology care.

According to the notice issued by the Executive, there are “significant waiting lists” for new patients across the country “due to limited capacity in services”.

The Community Audiology Service provides hearing assessments and management for “the full spectrum” of patients from infants to older persons. The chosen provider will help to “achieve good countrywide coverage which will be drawn down on by local HSE community service teams to meet the requirements of their service users”.

The delay in accessing services and receiving assessment/treatment leads to an impact on the quality-of-life for patients.

The notice recognises the impact that waiting times can have on children, in par-

ticular. It notes that untreated hearing loss “or late or delayed diagnosis with inadequate support has a detrimental impact on children’s development”.

It is understood that the HSE is seeking a provider to specifically perform paediatric diagnostic assessment and assessment management services.

According to HSE data, some 11,633 children are waiting for initial audiology assessment in the community.

In 2024, the Department of Health established a national hearing care plan working group jointly chaired by the HSE and the Department to examine capacity issues and other matters in the provision of hearing care.

The group is developing a hearing care plan, which will be informed by the World Health Organisation World Report on Hearing. A draft plan is expected in the coming months.

VOX BOX The proportion of pelvic osteotomies taking place at CHI at Temple Street and NOHC [National Orthopaedic Hospital Cappagh], despite not reaching the international criteria used in the audit, was so high that the audit report says further inquiry is mandated.

Renewing your registration is more than an annual legal requirement. By completing the ARAF [annual retention application form] doctors provide valuable data on the state of the medical workforce in Ireland.

HSE CEO Mr Bernard Gloster responding to the publication of the external audit report for Children’s Health Ireland on indications for pelvic osteotomy in children with developmental hip dysplasia.

Medical Council President Dr Suzanne Crowe commenting as the Council opened the annual retention process. The deadline for completion of the ARAF is 30 June.

The emergence and spread of resistant microbes threaten our ability to treat common infections and perform lifesaving medical and surgical procedures that allow people to live healthier for longer.

Chief Medical Officer Prof Mary Horgan commenting as the Department of Health and the Department of Agriculture, Food, and the Marine launched an online survey to inform the development of the next national action plan for antimicrobial resistance.

INTRODUCING

NEW CONSULTANTS AT BEACON HOSPITAL 2025 Dr Paul Shanahan

Ms Anna Walsh Consultant Urologist

Mr Diarmuid Molony

Consultant Orthopaedic & Trauma Surgeon

Dr Stephanie Menzies

Dr Emma Tierney

Dr Ibrahim Imam

Assoc Prof Tom Gallagher Consultant General Surgeon

Dr Anna Whelehan

Consultant Clinical Neurophysiologist

Dr Javaneh Lyons

Dr Wan Aizad Wan Mahmood

Dr Ikhwan Marion

Assoc Prof Charles Gillham

Dr Veronica Keatings

Dr John McHugh

Dr Lucy Perrem

Consultant Neurologist

Consultant Dermatologist

Consultant Rheumatologist

Ms Louise McLoughlin Consultant Urologist

Consultant Neurologist

Consultant Endocrinologist

Consultant in Respiratory & General Internal Medicine

Please see our website for the most up to date list of Consultants at Beacon Hospital

Consultant in Geriatric Medicine

Consultant Clinical Neurophysiologist

Consultant Dermatologist

Consultant Radiation Oncologist

Consultant in Paediatric Respiratory Medicine

THE MEDICAL INDEPENDENT | 3 JUNE 2025

10

News Feature DAVID LYNCH david@mindo.ie

Upskilling healthcare staff in genetics and genomics A recent international workshop hosted by the Mater Hospital aimed to address educational gaps in genomic medicine. David Lynch reports

I

n April, the Mater Misericordiae University Hospital in Dublin hosted the European Society of Human Genetics’ (ESHG) precision genomic medicine workshop.

The hybrid event had a focus on clinical utility. It was described by organisers as the first of its kind “in scale and scope globally”.

The workshop emerged through a collaboration between the Mater, the ESHG, the Human Genomic Society of Australasia, and the Canadian College of Medical Geneticists.

Speaking to the Medical Independent (MI), Dr James O’Byrne, Consultant Clinical Geneticist at the Mater Hospital, said the workshop’s aim was to provide practical education.

With the field of genomics making significant strides in recent years, an educational gap has emerged in its clinical use across medicine.

“This is the reason why [the workshop] is important and the reason why the three major genetics societies have come together for the first time to do this,” Dr O’Byrne told MI.

Dr James O’Byrne “Because there is a recognition that there needs to be a general upskilling of healthcare staff in the application of genetics and genomics in clinical practice.

“This is because, essentially, the technology that has developed to allow for genomics to be used in healthcare has pushed genomics into healthcare in a way that it can’t be ignored.”

Dr O’Byrne said these developments have caught many people working in medicine “by surprise”.

He added that too few healthcare professionals currently have the skills and knowledge to apply genomic technology in “an efficient, effective, and safe way”.

The lack of adequate education to support the implementation of these medical advances remains a significant challenge.

“Because the promise is huge around this,” said Dr O’Byrne, “but you have to know how to do it properly.”

He said it was vital for all healthcare staff – not just consultants but “the support staff around them” – to be informed about genomic advances.

“There has to be a general upskilling across the world.”

International The workshop welcomed speakers and attendees from 54 countries. The participants included educators and experts in the field of precision medicine from multiple clinical and academic institutions, including Ireland.

According to the organisers, the workshop provided up-to-date practical knowledge of the area and equipped the attendees with the basic principles of precision medicine.

Speakers included Dr Leslie Biesecker, Director of the Centre for Precision Health Research at the National Institutes of Health’s National Human Genome Research Institute, US. Dr John McDermott, Clinical Geneticist and National Institute for Health and Care Research Academic Clinical Lecturer, University of Manchester, UK, spoke on the everyday application of genomics in healthcare.

According to Dr O’Byrne, genomics is now being applied in “different shapes and forms” across healthcare.

“It’s not just about making a diagnosis in a patient or a family – it is also the different gene-related therapies that have come in – there are multiple strands to it and they are all interconnected... the bottom unifier is that someone is looking at the person’s DNA information.”

He added that much of this progress has only taken place over the “last 20 to 30 years”.

“There are gene therapies that are coming through now that we would have [only] talked about in the 1990s... we didn’t really see them until very recently.”

The workshop was designed to equip attendees with a broad understanding of key aspects of precision genomic medicine, including both current and emerging applications in germline and somatic contexts.

Participants learned how to build an effective, balanced multi-disciplinary clinic involving both laboratory and clinical experts. They also discussed gene- and genotype-driven therapies that are now becoming available in clinical practice.

Ethical considerations and the role of new technologies, such as artificial intelligence, were also central themes throughout the workshop.

According to organisers, modern healthcare increasingly enables clinicians and scientists to make accurate diagnoses and offer targeted therapies based on

There has to be a general upskilling across the world

well-defined, biologically informed disease subtypes. These approaches take into account individual differences in genetic makeup, behaviour, culture, lifestyle, and environmental factors.

Recent advances in science and technology – particularly in genomics – have generated new insights into the foundations of health and disease, ushering in a new era of medicine.

“It is often likened to the Wright brothers’ first flight in 1903 and then landing on the moon 66 years later,” said Dr O’Byrne, about the scale of recent progress.

From the completion of the Human Genome Project in 2003 to the development of next-generation sequencing – which has enabled “massive parallel sequencing” – the technology has become “a lot quicker and also a lot cheaper”.

Rather than costing billions of US dollars, sequencing a genome can now cost under a thousand dollars, with some now aiming for a ‘hundred-dollar genome’.

Timeframes have also shifted significantly, with processes that once took years now achievable in a matter of hours.

National strategy On a policy level in Ireland, there have been recent publications and developments in the area.

The National Strategy for Accelerating Genetic and Genomic Medicine in Ireland was published in December 2022. The National Genetics and Genomics Office (NGGO) was established in 2023 to drive the implementation of the strategy.

The NGGO has the stated aim of improving Ireland’s genetic and genomic medicine services.

Earlier this year, HSE National Doctors Training and Planning (NDTP) published a report entitled Clinical Genetics Medical Workforce in Ireland 2024-2038.

According to the document, as of July 2024, there were eight consultants employed within the HSE as consultants in clinical genetics.

These consultants all work full-time, with four expected to reach retirement age in the next 10 years.

The majority of this workforce are based in the Department of Clinical Genetics in Children’s Health Ireland (CHI) in Dublin.

The report also highlighted that cancer genetics services are provided at St James’s Hospital in Dublin by consultant medical oncologists with expertise in genetics.

However, these roles fall outside the scope of the NDTP report, which focused solely on consultants in clinical genetics.

According to the report, the current staffing level amounts to roughly 0.15 whole-time equivalent (WTE) consultants per 100,000 people – half the recommended minimum of 0.3 per 100,000 set by international guidelines.

Based on 2024 population figures, the report estimates a need for 16 WTE consultants in clinical genetics, rising to 18 WTE by 2038.

For more information about the precision genomic medicine workshop, visit: www.mater.ie/healthcare-professionals/ eshg-precision-medicine/

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.

Ref: VY 61MG 3_0 Last revised: 02/2023

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.

THE MEDICAL INDEPENDENT | 3 JUNE 2025

12

News Feature

Aid at a crossroads: Is it time for a new role for Europe?

As the US freezes foreign aid, Europe’s humanitarian leadership faces a crucial test.

Bette Browne asks can the EU step up – even as it too diverts funds toward military spending

E

urope’s humanitarian role on the global stage is more critical than ever, experts say, as the freeze on US foreign aid significantly undermines key international programmes.

Yet questions remain over whether Europe can fill the growing void, with escalating conflicts and rising military demands straining available resources.

Those who say that Europe can and will take the lead in providing humanitarian aid point to the fact that the European Union (EU) is the largest development aid donor in the world. It provided over €98 billion in development and humanitarian funding in 2022, almost half of all funding globally. In January, while President Donald Trump was announcing a US foreign aid freeze, the EU launched an initial humanitarian budget of €1.9 billion for 2025 on the basis that more than 300 million people will need humanitarian assistance this year.

“The EU is upholding its commitment to help those most in need as a leading humanitarian aid donor,” said the European Commissioner for Preparedness, Crisis Management, and Equality, Ms Hadja Lahbib, who announced the aid allocation. Her agency, the European Commission’s Civil Protection and Humanitarian Aid Operations department, known as ECHO, manages the EU’s humanitarian assistance.

Since 1992, the European Commission has provided humanitarian aid in more than 110 countries. This funding and support is delivered through a range of partners, including European humanitarian NGOs, international organisations such as UN agencies, and specialised bodies within EU member states.

The aid supports essential needs like food, shelter, healthcare, water, and sanitation. It is distinct from the EU’s emergency support for disasters within the Union. For example, earlier this year, Ireland received emergency energy assistance during Storm Éowyn.

Indeed, Ireland itself plays a central role in response to global aid challenges, according to Irish Aid. It contributed €2.3 billion in Official Development Assistance (ODA) in 2022, which included €0.9 billion allocated for donor refugee costs related to Ukraine.

The charity highlighted the fact that EU institutions fund over 160 ‘Team Europe Initiatives’ around the world.

“Ireland funds over 20 Team Europe Initiatives. We believe that cooperating with our EU partners is an excellent way to ensure real change is being delivered to people’s lives.”

Photo: istock.com/VlatkoRadovic

Ms Eva Hrncirova Commitment While the European Commission highlights the contribution of member states like Ireland in helping to make the EU the largest donor of development aid in the world, it is not resting on its laurels. It says the EU is committed to increasing its contribution and to donating at least 0.7 per cent of its gross national income a year to development aid, managed by the ECHO. This commitment was underlined by European Commission spokesperson Ms Eva Hrncirova in response to emailed questions from the Medical Independent (MI).

“As a leading donor of both development and humanitarian aid, the EU has long been at the forefront of supporting global efforts to promote sustainable development and tackle crises worldwide,” she said.

“The EU continues to remain committed to provide humanitarian assistance globally because we believe not only does it save lives, but it is also in our strategic interest. By tackling humanitarian crises,

we are also investing in security and stability in other countries.”

Ms Hrncirova also emphasised that aid must be allowed to be delivered safely to those in need.

“Respect of international humanitarian law is not only fundamental, it is a basic necessity,” she told MI. “This means protecting civilians during conflicts, civilian infrastructure like hospitals, and ensuring that aid workers are safe and not attacked.”

The largest amounts of EU humanitarian aid for 2025 have been allocated to Africa (over €500 million) and to the Middle East (€375 million). For Ukraine, the initial allocation is €140 million.

It is also worth noting that, since Russia’s invasion of Ukraine three years ago, the EU, its member states, and financial institutions have mobilised €67.7 billion to support Ukraine’s economic, social, and financial resilience. This support has taken forms such as macro-financial assistance, budget support, emergency aid, crisis response, and humanitarian assistance.

In addition, military assistance measures are around €48.7 billion, bringing total support to Ukraine to more than €100 billion.

Including the resources allocated to help member states support Ukrainians fleeing the war, the EU’s total assistance to Ukraine and its people amounts to nearly €135 billion. In addition, the EU has set aside over €295 million for global interventions, enabling rapid responses to sudden-onset emergencies and unforeseen humanitarian crises throughout the year.

In monetary terms, the US contribution to humanitarian assistance has been

enormous at over €72 billion in 2023, but this also includes military aid to countries like Ukraine and Israel.

By contrast, EU humanitarian aid exclusively covers areas, such as food and nutrition, shelter, healthcare, water and sanitation, and education in emergencies.

“All our aid is based on needs, and we provide it where it is needed most. This means in Gaza, Ukraine, in Syria, in the Democratic Republic of the Congo, and many other parts of the world. Sadly, conflicts are a leading cause of many humanitarian crises, as are increasingly natural disasters,” Ms Hrncirova noted.

Reversal The World Health Organisation (WHO) paints a bleak picture of such humanitarian crises and the devastating impact of aid cuts. The WHO predicts a reversal of decades of global progress in halting diseases and protecting people against them.

“We expect that by the end of 2025, up to 25 countries will include malaria vaccines in their childhood immunisation programmes. These vaccines could save tens of thousands of young lives every year.

However, many of the gains in malaria that have been made over the past 20 years are now at risk because of cuts to funding from the US for global health,” the WHO Director-General, Mr Tedros Adhanom Ghebreyesus, said in a press statement in Geneva on 17 March.

“If disruptions continue, we could see an additional 15 million cases of malaria and 107,000 deaths this year alone, reversing 15 years of progress. It’s a similar story with HIV. The suspension of most funding to PEPFAR – the President’s Emergency Plan for AIDS Relief – caused an immediate stop to services for HIV treatment, testing, and prevention in more than 50 countries.”

Over the past two decades, US support for tuberculosis services has helped to save almost 80 million lives.

“Those gains, too, are at risk,” he said.

“On immunisation, WHO’s global measles and rubella network of more than 700 laboratories, which was funded solely by the US, faces imminent shutdown. In many countries, the abrupt loss of US funding threatens to reverse progress in disease control, immunisation rates, maternal and child health, and emergency preparedness.”

He urged the US to continue funding humanitarian aid, stressing that making the world safer would also help protect the US. “We ask the US to reconsider its support for global health, which not only saves lives around the world, it also makes the US safer by preventing outbreaks from spreading internationally. And because health is wealth, fighting disease around the world supports global economic growth and stability, which benefits the US.” But it looks increasingly likely that the US will not heed this impassioned message. If it fails to do so, the WHO is urging other nations to increase their efforts to fill the void.

“Whether or not US funding returns, other donors will need to step up, but so too must countries that have relied on US financing, to the extent they can,” the Direc-

Continued on p14 

*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.

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 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: December 2023.

Two sprays per nostril twice daily 1

IR-RYL-06-2024 March 2024 1. Ryaltris™ Summary of Product Characteristics Oct 2023.

THE MEDICAL INDEPENDENT | 3 JUNE 2025

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News Feature



Continued from p12

tor-General said.

However, some experts warn that the EU’s commitment to funding humanitarian aid may come under pressure, as Europe faces growing demands to increase military spending in response to Russia’s ongoing aggression in Ukraine and President Trump’s abandonment of traditional military support for the continent.

Military funding In a chilling reminder of these new realities, the President of the European Commission, Ursula von der Leyen, declared in a speech at the Royal Danish Military Academy in Copenhagen, on 18 March: “If Europe wants to avoid war, Europe must prepare for war.”

She continued: “By 2030, Europe must have a strong European defence posture as it faces an aggressive Russia and the potential loss of US security protections. The truth is that I quickly became convinced that this truly exceptional period, during which we witnessed the fall of the Iron Curtain and the Berlin Wall, and entire countries and peoples were liberated, is a new norm. This led to underinvestment in defence and, frankly, to excessive complacency. Our adversaries used that period not only to regroup, but also to challenge the rules governing global security.”

Bolstering Europe’s defences also topped the agenda at an EU leaders’ meeting on 20 March after the Union endorsed a commission plan aimed at mobilising up to €800 billion over four years for defence equipment and related investments.

UK A month earlier, on 25 February, UK Prime Minister Keir Starmer announced that military spending would increase to 2.5 per cent of GDP by 2027 and that the country’s foreign aid budget would be cut.

He said it was “not an announcement I’m happy to make” and was aware of the fact that such spending cuts to overseas aid would harm many of the world’s most vulnerable people.

“I’ve taken a difficult choice today because I believe in overseas development, and I know the impact of the decision that I’ve had to take today and I do not take it lightly,” he told reporters at a Downing Street news conference.

“It is not a decision that I, as a British Labour prime minister, would have wanted to take, but a decision that I must make in order to secure the security and defence of our country.”

The move drew swift criticism, including from within Starmer’s own party. Labour MP Sarah Champion, Chair of the UK’s International Development Committee, called the decision “deeply short-sighted and [one that] doesn’t make anyone safer”.

Writing on X, she warned: “Development money can prevent wars and is used to patch up the consequences of them. Cutting this support is counterproductive.”

UK charities also condemned the cuts.

Prime Minister Keir Starmer

Prof Lawrence Gostin (PhD)

In a statement, the Catholic Agency for Overseas Development said the aid cut was “pulling a lifeline away from people in desperate need”. The agency’s CEO said it means that “in some of the most vulnerable places on earth, more people will die and many more will lose their livelihoods”.

Former UK Foreign Secretary Mr David Miliband, who now leads the International Rescue Committee, said that the decision to cut aid by £6 billion (€7 billion) in order to fund defence spending “was a blow to Britain’s proud reputation as a global humanitarian and development leader”.

The criticism continued unabated and three days after the Prime Minister’s announcement, the International Development Minister, Anneliese Dodds, quit her post.

Other cuts France also moved in February to slash its foreign aid by €2.1 billion in a 2025 spending bill.

The 37 per cent reduction followed an earlier cut of nearly €800 million in February 2024.

The new cut will not suspend hundreds of health or food aid programmes immediately, according to Le Monde.

“But the cut comes at a time when global poverty has stopped decreasing for the first time in three decades and low-income countries are stalling, choking under the weight of their debt,” the French newspaper stated.

“Some sectors must prepare for the worst. This is the case for humanitarian aid, which will have to operate with €500 million per year instead of €900 million, at a time when crises are multiplying,

I don’t see Europe having the political will to step up at a time of crisis

“Ultimately, these cuts will remove food and healthcare from desperate people – deeply harming the UK’s reputation,” Ms Dodds wrote in her resignation letter.

“I know you [Starmer] have been clear that you are not ideologically opposed to international development. But the reality is that this decision is already being portrayed as following in President Trump’s slipstream of cuts to USAID.” In reply, the Prime Minister said: “Overseas development is vitally important and I am proud of what we have done. The UK will still be providing significant humanitarian and development support and we will continue to protect vital programmes – including in the world’s worst conflict zones of Ukraine, Gaza, and Sudan.

“The decision I have taken on ODA was a difficult and painful decision and not one I take lightly. We will do everything we can to return to a world where that is not the case and to rebuild a capability on development.”

from Gaza to Goma.”

A month later, on 18 March, German lawmakers voted to allow a huge increase in defence spending, raising questions about the country’s future as the world’s third-largest development aid donor in 2023.

Citing such cuts by key donors like the UK, France, and Germany, Global health expert Prof Lawrence Gostin (PhD) questioned whether Europe had sufficient resources and political will to fill the gap in development assistance left by President Trump’s aid freeze.

“Europe has the capacity to help fill the major gaps in humanitarian assistance left by the US withdrawal and Europe’s values align with humanitarian causes like feeding the hungry, protecting the vulnerable, and fighting infectious diseases,” Prof Gostin, who is Professor of Global Health Law at Georgetown University in Washington, US, and Director of the WHO Collaborating Centre on National and Global Health Law, told MI. “And yet I don’t see Europe having

the political will to step up at a time of crisis. France and Germany have major political turmoil, and the UK recently announced it was actually cutting international assistance.

“Now that the US has disengaged, there is a shortage of both expertise and funding for international health and development.

Europe has the resources and expertise to add value. But, again, I am not seeing that happen,” he said.

If it does not happen, the consequences will be enormous for developing countries. But, as the Covid-19 pandemic illustrated, in an interlinked world there will also be consequences for countries that fail to provide the aid.

“Based on the current trajectory, 7 per cent of the world’s population, nearly 575 million people, will still be living in extreme poverty in 2030. In parallel, the impacts of climate change will disproportionately fall on the most vulnerable, and threaten to push an additional 132 million people into extreme poverty,” the Development Co-operation Report by the Organisation for Economic Co-operation and Development warned in November 2024.

“Ending global poverty and reducing inequalities are interlinked. Now is the time to address these issues, before these goals become harder and more costly to reach in the face of impacts of climate-induced extreme weather, shifting agriculture patterns, rising sea levels, and potential mass migration between and within countries.”

It has also been suggested by the US Centre for Global Development research group that European countries should look to Canada and Japan to help fill the void left by the US. “With USAID freezing funds and repatriating staff, there is an immediate need for other donors – particularly Germany but also Canada, Japan, and Sweden – to take the US’s place as lead provider in the most exposed countries,” the Centre said in a study in February. “Others, including China, Spain, and the UK should bring forward plans to increase assistance to prevent lives from being lost and fragile states from further destabilisation.”

“Should the US fully turn away from the world’s poorest countries, the effect on extremely poor people will be devastating. For governments prepared to commit a modest share of taxpayer revenue to saving lives, averting malnutrition, and maintaining stability, this is a moment to step up. Aid budgets must be reoriented towards the poorest countries – before the cost of inaction becomes irreversible.”

Ms Sania Nishtar, CEO of Gavi, the Vaccine Alliance, sounded a similar warning in an interview with Politico in March.

“As some countries of the world backtrack from development assistance, it would be very important for the EU to signal – to Africa in particular – that development is still a priority and that the EU is a reliable partner.”

Ms Nishtar said she recognised that security is vital for Europe. “But health security is a very important aspect of the security paradigm,” she said. “Both for the European Commission itself and for the EU as a whole, there is a real opportunity to demonstrate leadership [in global health].”

THE MEDICAL INDEPENDENT | 3 JUNE 2025

16

Coverage Conference RCPI Institute of Obstetricians and Gynaecologists, Spring Conference, No 6, Kildare Street, Dublin, 7 March 2025

Placental growth factor testing highlighted at obstetrics conference At a recent meeting, hosted by the RCPI, attendees heard how PlGF testing can help to reduce stillbirths

T

he RCPI welcomed obstetricians and gynaecologists to No 6, Kildare Street for a cross-border conference on Friday 7 March. The RCPI Institute of Obstetricians and Gynaecologists (IOG) annual Spring Conference is a key meeting in the College calendar, showcasing the latest research and practice in the area.

During the conference, Dr Suzanne O’Sullivan was appointed as the new IOG Chair, taking over from Prof Sam Coulter-Smith. Dr O’Sullivan is an accomplished obstetrician, gynaecologist, and sub-specialist urogynaecologist at Cork University Maternity Hospital. She has served as an elected Fellow on the RCPI Council, National Specialty Director for basic specialist training and higher specialist training, and National Director of Training at the IOG, where she led the development of an advanced simulation programme.

Among the eminent conference speakers was Dr John Kingdom, an obstetrician at Mount Sinai Hospital in Toronto, Canada, and co-founder of one of the world’s first dedicated placenta clinics .

Dr Kingdom argued that the inclusion of placental growth factor (PlGF) testing could transform pregnancy screening tests, with an estimated potential of lowering the tragedy of stillbirth by up to 50 per cent.

He recalled his time as an obstetrics trainee at the Queen Mother’s Hospital in Glasgow in the late 1980s and early 1990s.

Later, with the encouragement of a young consultant, he successfully applied for a Fellowship with the UK’s Medical Research Council to do research at its blood pressure unit in London.

“That’s where I got my interest in the placenta,” he said.

After two years of research, Dr Kingdom sub-specialised in foetal medicine at University College Hospital London, but soon decided to relocate.

“I didn’t want to do private practice. I wanted to do academia and make a difference.”

He secured an obstetrician position at Mount Sinai Hospital, where he was reunited with a peer from college, Dr Rory Windrim. Both had studied undergraduate medicine together at Trinity College Dublin in the early 1980s.

“He and I started a placenta clinic within a year of me arriving and we’ve done it together every Tuesday for 27 years, with women all over Ontario with placenta problems,” Dr Kingdom said.

Research With a long-time interest in the molecular biology of placental damage, he was very familiar with PlGF – a protein made in the placenta and secreted into the maternal blood. In 2013, he followed with interest a study from King’s College London, which observed a group of 625 women across seven different maternity units.

Known as the PELICAN Study, it suggested that measuring PlGF could help accurately diagnose pre-eclampsia. Over the next four years, Dr Kingdom managed to persuade the chief of pathology at Mount Sinai to explore PlGF testing.

An opportunity for a cohort study finally presented itself in 2020, during the first months of the Covid-19 pandemic. A call-out was issued for grant proposals to fund innovative new methods to reconcile healthcare needs with Covid-19 safety measures.

“You have got to show up for a blood test at 24 weeks anyway to check for diabetes. Why don’t we tag on a placental blood test?” he said.

Photo credit: David Coleman – Bobby Studio

Dr John Kingdom

“If your blood test is normal at 24 weeks, we can do remote, Zoom-based antenatal care and education safely, from week 24-36. We can therefore strip out a lot of patients coming to hospital for care who are scared to come, and make sure they’re safe and that their babies don’t die from undetected growth restriction and placental insufficiency.

“We ultimately screened 10,000 patients. Between one to two per 100 people would be considered having a low [placental] blood test [level]. For those people, we said we’re going to educate them, monitor their blood pressure, treat and prevent pre-eclampsia from becoming serious for the mother, introduce high-quality ultrasound imaging to monitor the baby, and, if necessary, step in early to deliver the baby and prevent [the baby] from dying inside the mother, so it will be a premature live-born baby that will do well. From this blood test, we’re able to identify 60 per cent of patients who are destined to deliver prematurely before 34 weeks.”

As the evidence of potential links between preventable stillbirth and placental insufficiencies and low PlGF levels become more compelling, new interest has emerged in dedicated placenta and PlGF testing services.

Dr Kingdom spoke fondly of being a medical student in Dublin during the early 1980s, (“I lived above the

We can substantially lower the tragedy of stillbirth by, I’d say, 50 per cent

neonatal unit in the old part of the Rotunda. There were so many beautiful historical buildings as hospitals.”).

While in Dublin for the RCPI conference, he visited the National Maternity Hospital and Rotunda Hospital – both have interest in setting up placenta programmes.

“These approaches we expanded 25 years ago are really coming into play in Irish hospitals as well,” he said.

Stillbirth rate “The stillbirth rate in Ireland is about three or four per 1,000. That’s pretty similar to Canada. What we’re trying to do is minimise the risk of preventable tragedies in pregnancy. What counts is that the placental insufficiencies that killed the baby a week before labour could have been detected much earlier from this blood test, and the patient then could then have been monitored and perhaps had a caesarean delivery or induction of labour two weeks earlier, and therefore have a live-born child that’s healthy.

“The placental complications of pregnancy are the common things doctors and midwives fear. They’re scared of a patient having an eclamptic fit or a stillbirth, or a sudden placental separation where they start bleeding. Here’s a simple way for all of us to substantially lower our fear of these big complications of pregnancy. We can substantially lower the tragedy of stillbirth by, I’d say, 50 per cent,” he said.

During his presentation, Dr Kingdom argued that including PlGF testing could transform pregnancy screening tests. The dominant multi-modal intervention model – combining information about a patient’s ethnic background, weight, pregnancy history, etc, into a sequential algorithm – could be replaced by a more universal, uni-modal blood test. “I think it can make a real difference in obstetrics and maternal foetal medical care,” he said.

Themed ‘Celebrating Obstetrics and Gynaecology’, the conference marked the first time that RCPI’s IOG hosted a joint meeting in No 6, Kildare Street, Dublin, with the Royal College of Obstetricians and Gynaecologists (RCOG) UK, and the Ulster Obstetrical and Gynaecological Society (UOGS), Northern Ireland.

UOGS President Dr Kristine Steele presented on a new category of ectopic pregnancy that is asymptomatic. She urged against gynaecologists feeling pressure to perform unnecessary intervention and recommended expectant management as a treatment.

Dr Ranee Thakar, RCOG President, gave an update on how her college was addressing women’s health priorities through several new projects, including a new Race Equity Project (feedback revealed that 75 per cent of the College’s membership witnessed racial discrimination at work) and a new Avoiding Brain Injury in Childbirth programme co-designed with Royal College of Midwives.

“We have seen nearly a 60 per cent increase in gynaecology referrals in three years up to 2022,” said RCPI IOG Chair, Dr O’Sullivan. Noting the upcoming seventh anniversary of the HSE’s pause on vaginal mesh implants, she thanked Dr Thakar and Dr Lucia Dolan, who volunteered their free weekends to help provide vaginal mesh removal training in the Republic of Ireland. Dr O’Sullivan also said that all 19 recommendations made by the Chief Medical Officer have been addressed.

“I feel our specialty is good at collegiality. If we reach out to each other, there’s a lot we can do,” said Dr O’Sullivan.

This article was produced by the RCPI.

THE MEDICAL INDEPENDENT | 3 JUNE 2025

17

Editorial

PAUL MULHOLLAND paul@mindo.ie

Mounting concerns for Children’s Health Ireland

T

he controversies surrounding Children’s Health Ireland (CHI) show no sign of abating.

Less than two months after HIQA released its damning report into experimental spinal procedures at CHI at Temple Street, another critical publication has followed: A clinical audit examining hip surgery thresholds for children with developmental dysplasia of the hip (DDH).

The audit was triggered by a protected disclosure raising concerns that CHI at Crumlin, CHI at Temple Street, and the National Orthopaedic Hospital Cappagh (NOHC) may have used differing criteria to determine whether DDH surgery was required.

In July 2024, CHI and NOHC announced a joint clinical audit of a random, anonymised sample of DDH surgeries performed between 2021 and 2023. The audit was carried out by a UK-based paediatric orthopaedic consultant with specialist expertise in this area and the results were published at the end of May. The audit reviewed 147 anonymised cases across the three hospitals. Applying retrospective criteria for evaluation, it found significant variation in the thresholds used to recommend pelvic osteotomy procedures. The auditor raised concerns about the indications for surgery in many cases at CHI at Temple Street and NOHC. In contrast, children who underwent surgery at CHI at Crumlin were found to have been appropriately selected for the procedure, according to current international standards.

The audit identified one case in which a child experienced complications due to the surgical approach taken. The family has been contacted and supported through an open disclosure process.

The HSE will now oversee the implementation of the recommendations.

This will include the establishment of an expert panel or panels to respond to queries which may arise from patients and their families in relation to their individual procedures and whether they were necessary.

A plan has been developed to review approximately 1,800 children and young adults who underwent this surgery at CHI at Temple Street and NOHC since 2010, with follow-up continuing until they reach skeletal maturity. The audit also recommends long-term monitoring for all children who undergo pelvic osteotomy and clinical teams at CHI and NOHC are now working to implement this guidance.

“There is little doubt that the fi ndings of this audit raise significant concern,” according to HSE CEO Mr Bernard Gloster.

“Focus on follow-up and putting in place a mechanism to ensure this kind of variation can’t recur is central to our next steps.”

In addition to the audit, a separate CHI internal investigation, recently reported on by The Sunday Times, questioned the manner in which public patients were referred to a private clinic through the National Treatment Purchase Fund.

Mr Gloster said he was “shocked” by the revelation and that any evidence of misuse of public funds will be referred to the gardaí.

In the wake of these controversies, a number of members have resigned from the CHI board.

And with the news that the opening of the New Children’s Hospital has been delayed yet again, political scrutiny of our paediatric services is only likely to intensify.

READER COMMENTS REACTION TO OUR NEWS STORY, ‘NCCP CALLS FOR MORE “IN-HOUSE” COMPOUNDING OF ANTI-CANCER THERAPIES’, 20 MAY “Prof Ó Laoide and the @hseNCCP are correct on this point. The advantage of on-site compounding is that dose changes or treatment change decisions can be made in real time. Outsourcing to private companies in most cases means ordering SACT 2 weeks in advance. It increases inflexibility in the system. The objective should be to increase efficiency. Maximise onsite SACT compounding.”

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Prof @offiah_gozie, MPS Council member for Ireland and Chair of the MPS Foundation, discusses in @med_indonews @CfAA_York @Improve_Academy.”

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THE MEDICAL INDEPENDENT | 3 JUNE 2025

18

Opinion Medico-Legal MS CLAIRE CREGAN, Legal Counsel, Medisec

Recording clinical consultations Ms Claire Cregan addresses the ethical and legal considerations of patients recording consultations

I

n January 2024, the Medical Council published its updated Guide to Professional Conduct and Ethics for Registered Medical Practitioners (‘the Guide’). It includes the following best practice guidance on photographic, video or audio recording by a patient during a consultation: “You should be aware that patients may wish to record all or part of a consultation. If they wish to do so, you should facilitate their request. If you consider that recording could have a negative impact on your consultation, you should explain this to your patient and, if possible, come to agreement.”

While some doctors may be comfortable to have their consultations recorded and believe that a genuine recording serves to protect doctors and to provide evidence of their professionalism, we understand from speaking with our members that the majority do not favour their patients recording their consultations and have cited several reasons for their views. Some advised that the recording device (usually a smartphone) placed in the middle of the room is an unnecessary distraction and can interrupt the natural flow of the consultation. Others have highlighted that an audio recording is unlikely to capture the full extent of what was discussed; for example, the nature of a physical examination or the non-verbal communications that can be important during a consultation.

At Medisec, we are often asked by our members how they should manage and facilitate requests by patients to record their consultations and to clarify if it is legal for a patient to make a recording; whether done overtly or covertly.

Is it legal?

In Ireland, there is no specific legislation to prohibit a patient from recording their own clinical consultation, with or without the doctor’s knowledge and consent. This may seem unfair to the treating clinician, particularly where the patient is recording covertly. However, where it is the patient’s own personal and sensitive clinical information being discussed during the consultation, and the recording is for the patient’s own personal use, the General Data Protection Regulation (GDPR) will not apply to this recording.

There may, however, be situations where other rights and laws place limits on what the patient can do with their recording.

For example, if the doctor’s personal information was recorded, their constitutional right to privacy or rights under the European Convention on Human Rights may limit how the patient could use the recording. If the patient altered or edited the recording to damage the reputation of the doctor, publication of that recording could form the basis for a claim for defamation by the doctor.

By comparison, if the doctor decided to record a patient consultation, the ob-

also be happy to send a letter following the consultation, detailing any pertinent clinical information discussed. It may also be appropriate to suggest that a family member or support person attend the consultation with the patient.

If agreement cannot be reached and the patient refuses to stop recording the consultation, despite the doctor discussing their concerns/reservations, and alternative options with the patient, it will be a matter for the doctor to consider whether recording could have a negative impact on the consultation.

To avoid any potential patient safety issues, we do not recommend immediately terminating the consultation, or without first assessing the patient to ensure there are no serious clinical issues requiring urgent attention. It is worth bearing in mind that a refusal to proceed with the consultation or to assess the patient is likely to be recorded and may result in a patient complaint.

The doctor will then have to determine whether they are comfortable to continue treating the patient in the future, or if they believe the therapeutic relationship has irrevocably broken down as a result.

Credit: istock.com

In Ireland, there is no specific legislation to prohibit a patient from recording their own clinical consultation, with or without the doctor’s knowledge and consent

ligations placed on data processors and controllers under Articles 17-19 of GDPR would apply to that recording, as they would be processing the sensitive personal data of another person.

The Guide also provides guidance to doctors who “determine that making audio, video or photographic recordings of a patient is necessary and appropriate for patient-care and/or beneficial for education and training purposes”.

The guidance includes an absolute duty on the doctor who “must explain this to the patient and obtain their consent to both the making and any proposed sharing of a recording” and “must take particular care in relation to the storage and sharing of recordings of a patient”.

The Guide further states that the doctor “must take all reasonable and required steps” to ensure that they follow their professional duty of confidentiality, as well as their legal duties regarding data protection.

In summary, it is necessary for a doctor to inform and seek consent from a patient prior to recording their consultation, but the same level of disclosure is not required from the patient.

Negative impact Although it is not unlawful for a patient to record their consultation, the Guide acknowledges that this may impact negatively on the consultation and encourages discussion and agreement on the issue between the doctor and their patient.

Where the therapeutic relationship between a doctor and a patient is based on mutual trust and respect, it is important for the doctor to explain any discomfort with being recorded. They should clearly outline their reasons and seek to understand why the patient wishes to make a recording in the first place.

The patient may have valid or personal reasons. For example, they may have poor hearing or have difficulty retaining clinical information and this could be embarrassing for the patient. Following an open and honest discussion, it may be possible to reach agreement on the use of alternative options. In some circumstances, it may be appropriate for the doctor to use visual aids throughout the consultation or to provide information leaflets to the patient. The doctor may

Breakdown of therapeutic relationship The Guide acknowledges that good medical practice depends on doctors working together with patients towards shared aims and with mutual respect and describes the relationship as a partnership dependent on establishing trust, working collaboratively, and communicating effectively with patients.

Although the act of recording a consultation may not in itself be sufficient to ask a patient to attend another doctor, if a doctor believes that it negatively impacts them to the point they are unable to continue to provide effective care to the patient because the therapeutic relationship has broken down, it may be in the patient’s best interests to receive their clinical care from another doctor.

It is important that the doctor adopts a fair, balanced, and unbiased approach to managing the situation.

We appreciate that the breakdown of a doctor-patient relationship can be challenging and these conversations can be difficult. Prior to asking a patient to attend another doctor, we recommend seeking specific advice from your indemnifier on how best to manage the situation.

In conclusion, it is important for doctors to be aware of the Medical Council’s best practice guidance to facilitate a patient’s request to record their consultation if they wish to do so, while also considering the impact this may have on their consultation and overall therapeutic relationship with their patient. We appreciate that each patient and each consultation will be different and we strongly encourage doctors to seek specific guidance from their indemnifier.

THE MEDICAL INDEPENDENT | 3 JUNE 2025

19

Opinion

The joy of hanging out the wash Putting clothes out to dry is a means of connecting with all the women who went before me DR LUCIA GANNON Read more by Dr Lucia Gannon at www.mindo.ie @LuciaGannon

The cool that came off sheets just off the line Made me think the damp must still be in them But when I took my corners of the linen And pulled against her, first straight down the hem And then diagonally, then flapped and shook The fabric like a sail in a cross-wind, They made a dried-out undulating thwack.

Seamus Heaney, Clearances (In Memoriam M.K.H.)

O

ne of my favourite things to do in summer is to hang washing on the line. Even more than slipping newly painted toenails into open toe sandals, or the taste of a perfectly crafted 99 topped with a Cadbury flake. To stand beneath the recently awakened branches of the cherry trees, blossoms sprinkled like confetti at my feet and slowly, methodically peg a basket of freshly washed sheets or towels on the line, while swifts and swallows swoop and soar and pigeons thrash in and out of the laurels, there is no greater joy. Honestly! A sunny day, a gentle breeze and I will scour every wardrobe, every drawer, every nook and cranny of the house, gathering unloved, discarded, slightly sniffy shirts or socks, anything that can be put in a washing ma-

chine and strung on a line.

My clothesline is an old-fashioned, fixed, double-corded structure, strung between two poles. It has a pulley system for raising and lowering so I don’t have to stand on my toes to reach it. I had chosen the place for its installation as the first blocks of our house were being laid. It would be a sacred place, I knew.

I say ‘my’ clothesline because even though others use it occasionally, I am the one who lovingly cleans the nylon cord, oils the cranking handle, and replenishes the store of clothes pegs every year, as the days lengthen and the rain takes a well-deserved rest. And it is I who makes numerous trips, up and down the garden steps, standing in that space, shaking, stretching, hanging, and folding the family’s laundry. It isn’t a chore. It’s a means of connecting with all the women who went before me and those women everywhere who still perform this act. Because laundry has usually been women’s work, and there is something about hanging it on the line, raising it to the sun, allowing it to billow freely in the breeze, that lifts this task (and all the other unseen repetitive, menial chores that women perform) out of the shadows, releases it from all associations with punishment, shame, drudgery, and powerlessness.

My daughter-in-law told me that her mother always insisted on hanging out the wash. There was a correct way of doing it, she had said. Large items like towels and sheets went on the line that faced the street, smaller more personal items (unmentionables) on the line facing the kitchen. She had learned this from her own mother and while she really didn’t care who saw her washing, nothing would make her break this habit. She had been late for a flight once because on her

Swearing under pressure Is swearing really just rude, or can it actually help us cope?

DR MUIRIS HOUSTON Read more by Dr Muiris Houston www.mindo.ie @muirishouston

A

m I the only one to observe an increase in apologies by sports commentators for “offensive language you may have heard”?

I’ve noticed it more this season in coverage of the United Rugby Championship and, perhaps more surprisingly, when watching the latest Masters golf tournament. It may be that on-course and referee microphones are more sensitive or it could be due to a real increase in bad language in the sports environment.

Interestingly, motorsport’s governing body, the FIA (Fédération Internationale de l’Automobile), has suggested it may introduce a ban on swearing in Formula 1 team radio communication. Recently, the FIA President, Mohammed Ben Sulayem, said the body could “shut down the radios of live communication” over the issue.

For some, the idea that drivers need to swear during races may seem unconvincing, given that emotions can be expressed through other word choices. Many of us are not permitted to swear in our workplaces, so why should Formula 1 drivers be any different?

Research, highlighted recently in The Conversation, suggests that prohibiting drivers from using strong language

during races might have unintended consequences. In the intense, high-stakes world of Formula 1, such a ban could interfere with how drivers manage their emotional responses under pressure.

Drivers themselves have pushed back, claiming that their use of profanity isn’t simply casual or careless – it serves as an essential outlet, helping them cope with the psychological demands of their high-adrenaline environment.

The author of The Conservation article, Kieran File, Associate Professor at the Department of Applied Linguistics, University of Warwick, writes that research may support this claim as studies have shown that swearing is deeply linked to emotional regulation.

“Experimental and lab-based studies suggest that swear words are processed differently to other words. They have been linked to brain regions responsible for processing emotion, threat detection, and survival responses,” he writes.

“Some studies also suggest that swearing activates the fight-or-flight response, triggering physiological changes like increased heart rate, faster breathing, and adrenaline release. The fight-or-flight response is an instinctive mechanism that helps humans react to danger.”

Formula 1 drivers are required to make rapid, precise choices while staying mentally sharp. In that context, letting off steam through swearing – and the physical activation that comes with it – might actually support their ability to stay focused and perform at their best. And swearing isn’t just about emotional release or mental focus – it may also help raise pain tolerance. This could be particularly relevant for Formula 1 drivers, who endure extreme physical

way to the car she noticed the shirts hanging the wrong way around and had to fix them.

My daughter-in-law is from Glasgow, a city where the old tradition of drying laundry on poles in the public green is guaranteed by city law. Up until the 1970s people would wash their clothes in communal sinks or washhouses and peg them on lines strewn between iron drying poles. The poles still exist but are never used. I imagine there was competition for the most aesthetically pleasing clothesline. In other parts of the city, where houses opened onto a communal back garden, it was common for women to rescue each other’s laundry at the first drop of rain, quickly grabbing it from the line, and leaving it in a strategically placed basket inside the unlocked back door. Laundry, it seems, fosters community.

Unlike Glasgow, the US has laws that forbid most people from hanging washing outside. Younger generations will never see a line of tiny babygrows or stark white sheets flapping in the wind or savour the plant and floral scents of line-dried clothes. Instead, they will rely on painters and poets, like Heaney, who commemorates his mother in the poem above, to conjure this nostalgic practice.

In London, Parliament Square’s first monument to a woman and first sculpture by a woman was unveiled in 2018. It is the suffragist Dame Millicent Fawcett, designed and created by the artist Gillian Wearing, and stands alongside similar monuments to Winston Churchill, Lloyd George, and other male leaders. In her hands, Fawcett holds a banner that reads, ‘courage calls to courage everywhere.’ The initial design was modified as the Westminster City Council thought that Fawcett looked like she was hanging out the wash. What, I wonder, was wrong with that?

stress and the discomfort of being strapped into a cramped cockpit for long stretches.

Also, swear words tend to trigger stronger mental responses than neutral language, according to research, which means they can be especially useful in urgent situations. In the context of racing, a message that includes expletives might prompt a quicker reaction from race engineers and support staff, signalling the need for immediate attention or action, File notes.

As I read his piece, I have to admit, it crossed my mind that the same arguments could be made by those undertaking emergency surgery. As far as I am aware, surgeons do not use expletives when working under extreme operating theatre pressure. In general, the Medical Council takes a dim view of swearing at or in front of patients. So whatever about research that might back up such behaviour, I can’t see the regulatory authority taking a more liberal view of the practice.

Taboo language encompasses a wide spectrum of offensive expressions, including general profanity, personal insults, and more extreme forms such as racial slurs and hate speech.

Another article in The Conversation discussed a 2024 study published in Behaviour Research Methods, entitled ‘Taboo language across the globe: A multi-lab study’.

The study compared speakers from different regions. It found that participants from Spain and the UK produced fewer than 16 taboo terms each on average, while Belgian Dutch speakers listed nearly twice as many. Preferences for specific words also varied. For instance, “shit” appeared among the 10 most commonly mentioned taboo words by English and Italian speakers, but didn’t feature prominently for French, Dutch, Spanish, or German respondents.

It seems swearing serves as a cultural mirror, reflecting what topics are considered off-limits and what boundaries are being tested.

Just don’t expect to hear it in a professional medical setting near you.

THE MEDICAL INDEPENDENT | 3 JUNE 2025

20

Clinical Haematology THERESA LOWRY LEHNEN, RGN, PG Dip Coronary Care, BSc, MSc, RNP, PG Dip Ed (QTS), M Ed, PhD, FFNMRSCI, Advanced Nurse Practitioner, General Practice

Sickle cell disease: An overview Sickle cell disease is a complex, systemic disorder, and healthcare staff awareness of its risks and acute presentation is vital to reduce the risk of morbidity and mortality

S

ickle cell disease is a monogenic, inherited haemoglobinopathy that results in multisystem complications due to chronic haemolysis, vaso-occlusion, and inflammatory endothelial dysfunction.

It is most prevalent in people of African or Caribbean background. The disease poses a significant global health burden and affects approximately 20-to-25 million individuals globally, with an estimated 300,000 infants born annually with the condition. This figure is projected to rise due to demographic growth in high-prevalence regions such as sub-Saharan Africa and India.1,2,3 In some high-income countries, improved neonatal screening and comprehensive care programmes have extended life expectancy for those with sickle cell disease, but morbidity remains significant.

Sickle cell disease is classified as rare within the EU. The 2017 EU Rare Diseases Plan established 24 European Reference Networks (ERNs), including ERN-EuroBloodNet which is focused on rare haematological conditions. This initiative enhanced collaboration across member States and identified unmet needs in care provision, aiming to improve the management and treatment of individuals with rare diseases such as sickle cell disease.4 While the patient population in Ireland remains relatively low, at an estimated 600 people, the prevalence of sickle cell disease is rapidly growing here due to migration patterns.

Pathophysiology Sickle cell disease is an autosomal recessive haemoglobinopathy. The clinical hallmark is a triad of painful vaso-occlusion, micro-infarct end organ damage, and a haemolytic anaemia.

The condition arises from a single point mutation in the β-globin gene, resulting in the substitution of valine for glutamic acid at position six of the β-globin chain, forming haemoglobin S (HbS).1,2,3 Under hypoxic, acidic, or dehydrated conditions, the mutant HbS undergoes a structural change that promotes polymerisation of the deoxygenated HbS tetramers. This polymerisation forms long, rigid intracellular fibres that distort the normal biconcave erythrocyte into the characteristic sickle shape. The sickling process is initially reversible; however, with repeated cycles of deoxygenation and reoxygenation, red blood cells (RBCs) become permanently deformed and lose membrane flexibility.1,5 These distorted erythrocytes are rigid, poorly deformable, and more adhesive to the vascular endothelium and to each other. Their impaired deformability hinders passage through the microcirculation, leading to vascular occlusion, tissue hypoperfusion, and local ischaemia.

These events precipitate painful vaso-occlusive crises and underlie many of

and kidneys.1,2,3,6,7 Acute chest syndrome is the most common cause of hospitalisation for patients with sickle cell disease, with a peak incidence in early childhood, and is responsible for approximately 25 per cent of sickle-related deaths.

the acute and chronic complications associated with the disease.5,6,7 Sickled cells have a shortened lifespan, with an average survival of only 10-to-20 days compared to the normal 120 days for healthy RBCs. This accelerated destruction leads to chronic haemolytic anaemia.

Intravascular haemolysis results in the release of cell-free haemoglobin into the plasma, which rapidly binds to and depletes nitric oxide, a critical vasodilator.

The resultant nitric oxide scavenging contributes to vasoconstriction, endothelial dysfunction, and platelet activation, creating a pro-inflammatory, and prothrombotic vascular environment.5,6,7 Haemolysis frees arginase-1 and other erythrocyte-derived molecules that exacerbate nitric oxide depletion and promote oxidative stress. The exposed phosphatidylserine on the outer membrane of sickled RBCs enhances their clearance by macrophages and supports a hypercoagulable state. Concurrently, leukocytes, particularly neutrophils, become activated and adhere to the endothelium, secreting pro-inflammatory cytokines and generating reactive oxygen species that amplify vascular injury.5,6,7 Endothelial cells respond to this by upregulating adhesion molecules such as VCAM-1, ICAM-1, and E-selectin, which further facilitate the entrapment of sickled erythrocytes, platelets, and leukocytes. This adhesive interaction is central to the pathogenesis of vaso-occlusion.

The cumulative effect is a cyclical cascade of hypoxia, inflammation, endothelial activation, and microvascular occlusion that leads to ischaemia-reperfusion injury and promotes progressive damage to vital organs. 5,6,7 Over time, these pathophysiological processes culminate in multisystem organ dysfunction. In the lungs, recurrent infarction and inflammation contribute to the development of pulmonary hypertension and acute chest syndrome. The brain is highly susceptible to both overt stroke and silent cerebral infarction, particularly in children. Chronic renal injury develops from persistent hypoperfusion and glomerular hyperfiltration, while

avascular necrosis occurs in bones due to repeated ischaemic insults. In the eyes, proliferative sickle retinopathy can result in visual impairment or blindness. The spleen is often rendered non-functional early in life due to repeated infarctions, leaving individuals highly susceptible to bacterial infections.5,6,7 Clinical presentation Sickle cell disease is typically asymptomatic in early infancy, with manifestations emerging as foetal haemoglobin levels decline.1 Over time, a variety of factors influence the severity and type of symptoms. Common features of the disease include haemolytic anaemia, chronic low-level pain, and intermittent vaso-occlusive crises, often causing pain in bones and joints. Other complications include hand-foot syndrome, acute chest syndrome, splenic sequestration, vision loss, growth retardation, leg ulcers, deep vein thrombosis, and organ damage, particularly to the liver and bones.2,3,6,7 Cardiac, renal, and hepatic disorders, along with gallstones, priapism, and, notably, stroke, are also prevalent. Children with sickle cell disease are at risk of asymptomatic strokes, ischaemic stroke, sino venous thrombosis, posterior leukoencephalopathy, and acute demyelination, which can lead to additional complications, such as seizures, learning difficulties, physical disabilities, and coma. Painful crises caused by vaso-occlusion and bone infarction are common, with dactylitis (painful swelling of fingers or toes) seen in infants.1,2,3,6,7 Long-term complications of sickle cell disease include avascular necrosis of bones, especially in the heads of long bones, leading to joint damage. Osteopaenia and osteoporosis can contribute to vertebral collapse and chronic back pain. Factors such as higher haematocrit levels and the presence of α-thalassemia trait have been linked to an increased risk of bone infarctions, although the data remains inconclusive. Among the most frequent morbidities related to sickle cell disease are pain crises, cerebrovascular accidents, and dysfunction of the spleen

Diagnosis Sickle cell disease can be diagnosed in utero or in the new-born period by screening, or be detected at any time during life. Diagnosis is established through haemoglobin electrophoresis or high-performance liquid chromatography, with confirmation by genetic testing if necessary. New-born screening programmes are established in some high-income countries, allowing for early diagnosis and the initiation of prophylactic measures such as penicillin prophylaxis and vaccination against Streptococcus pneumoniae and Haemophilus influenzae. In low-resource settings, however, diagnostic infrastructure is often lacking, resulting in delayed identification and increased early mortality.1,2,7 Ireland does not currently screen all new-born babies for sickle cell disease as part of the national new-born screening programme. However, there are calls to expand the screening programme to include sickle cell disease, as it is part of new-born screening in other European countries.

Targeted screening for sickle cell disease for babies at increased risk based on their family history is available in Ireland, and blood tests in pregnancy should be offered for those who may be at risk. 8 Management strategies Treatment goals for sickle cell disease primarily focus on preventing and managing symptoms (pain) and complications.1,2,9 Timely identification and intervention are important to minimise disease-related morbidity and pain. This includes regular monitoring, such as transcranial Doppler ultrasounds in children to assess stroke risk, early detection and management of pulmonary hypertension, and surveillance for organ dysfunction commonly associated with the disease.3,7,10 Most patients with sickle cell disease will experience vaso-occlusive events at some point in their life and these episodes account for the vast majority of emergency hospital admissions. They can lead to acute organ failure or chronic organ damage affecting all systems.

A range of disease-modifying therapies are available to reduce the frequency and severity of sickle cell disease complications. Hydroxyurea remains a cornerstone of treatment. It functions by increasing levels of foetal haemoglobin, thereby reducing red cell sickling and haemolysis.

Additionally, hydroxyurea lowers circulating leukocyte counts, which helps reduce inflammation and vascular adhesion events. Other treatments include crizanlizumab, a P-selectin inhibitor that mitigates vaso-occlusion by reducing cel-

THE MEDICAL INDEPENDENT | 3 JUNE 2025

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Haematology Clinical

lular adhesion, and voxelotor, a HbS polymerisation inhibitor that stabilises haemoglobin in its oxygenated form, thereby improving haemoglobin levels and reducing haemolysis.2,3 7,9,10 Supportive multidisciplinary care continues to play a vital role in managing acute complications and preventing long-term sequelae. This includes blood transfusion therapy for stroke prevention and acute anaemia, and iron chelation for transfusional siderosis. As blood transfusion therapy is of benefit in both the acute management of vaso-occlusive events and chronic management to prevent micro-infarct end organ damage, most patients with sickle cell disease will undergo numerous transfusions in their lifetime.

Comprehensive care models are important to optimise outcomes.2,3,7 Emerging therapies Ongoing clinical trials are evaluating newer agents aimed at targeting the underlying pathophysiology of sickle cell disease through diverse mechanisms.

These include agents that reduce HbS polymerisation, such as pan-histone deacetylase inhibitors, and DNMT1 inhibitors. Therapies targeting oxidative stress and inflammation are also under investigation. For example, carbon monoxide-releasing molecules aim to improve oxygen delivery, while phosphodiesterase-9 inhibitors are being explored for their potential to raise foetal haemoglobin levels.7 Investigational agents include poloxamer and vepoloxamer, which are surfactants designed to prevent red cell adhesion and improve blood flow, thus reducing vaso-occlusion. Inflammatory pathways are another focus, with therapies being tested to inhibit platelet activation, modulate immune response, or target endothelial dysfunction. Anticoagulants like rivaroxaban and antioxidants such as N-acetylcysteine are also under evaluation for their roles in minimising thrombosis and oxidative injury, respectively.7,10 This multifaceted therapeutic approach highlights the complexity of sickle cell disease and the importance of individualised treatment plans that address both acute complications and longterm disease progression. While these agents represent important additions to the therapeutic arsenal, their cost and limited long-term data remain barriers to widespread adoption.

References 1. Mangla A, Agarwal N, Maruvada S. Sickle cell anemia. StatPearls Publishing; 2025. Available at: www.ncbi.nlm.nih.gov/ books/NBK482164/ 2. Kavanagh L, Fasipe T, Wun T. Sickle cell disease: A review. JAMA. 2022 Jul 5;328(1):57-68 3. O’Brien E, Ali S, Chevassut T. Sickle cell disease: An update. Clin Med (Lond).

2022;22(3):218-20 4. Mañú Pereira M, Colombatti R, Alvarez F, Bartolucci P, Bento C, Brunetta A, et al. Sickle cell disease landscape and challenges in

Curative therapies Allogeneic haematopoietic stem cell transplantation remains the only established curative therapy for sickle cell disease. Outcomes are most favourable in children with matched sibling donors, with event-free survival rates exceeding 90 per cent. However, only a minority of patients have access to a suitable donor.

Advances in haploidentical transplantation and the use of reduced-intensity conditioning regimens are expanding the potential candidate pool.10 Gene therapy has emerged as a transformative frontier in treatment. Recent approaches include lentiviral vector-mediated addition of anti-sickling β-globin genes and gene editing strategies to reactivate foetal haemoglobin production. In 2021, a study (CRISPR-Cas9 gene editing for sickle cell disease and β-thalassemia) reported the successful application of

sations, and complications, contributes to emotional distress, anxiety, and difficulty coping. Daily life is often disrupted due to physical limitations, treatment regimens, and the unpredictability of disease-related events. These challenges can lead to reduced participation in educational, occupational, and social activities, significantly affecting quality-of-life.1,2,3,9 Neurocognitive impairments, in combination with the physical symptoms of the disease, may hinder the individual’s functional abilities. Psychological distress is common and requires ongoing support.

A comprehensive care approach is important, especially during hospital admissions or periods of crisis. Disruptions in schooling during key developmental stages can affect academic progress and social development, while the burden of care may place strain on family relationships and routines.1,2,3,9

Sickled cells have a shortened lifespan, with an average survival of only 10-to-20 days compared to the normal 120 days for healthy red blood cells

CRISPR-Cas9 gene editing in a small cohort of patients, resulting in transfusion independence and resolution of vaso-occlusive crises. The subsequent US FDA approval of exagamglogene autotemcel in 2023 marked the first approved CRISPR-based gene therapy for sickle cell disease, setting a new precedent in precision medicine. While these advances are ground-breaking, longterm safety data, and equitable access are key considerations.11,12

ience and overall wellbeing.1,2,3,9 In 2021, a UK All-Parliamentary Group on Sickle Cell and Thalassaemia published a report which highlighted that “awareness of sickle cell among healthcare professionals is low, with sickle cell patients regularly having to educate healthcare professionals about the basics of their condition at times of significant pain and distress”.13 Specialised services for sickle cell disease St James’s Hospital in Dublin has a specialised service for sickle cell disease and thalassaemia, also referred to as the haemoglobinopathy service. The service is available to adult patients diagnosed with sickle cell disease or thalassaemia, referred by their GP, consultant, or through a transition clinic. The primary goal is to offer specialised medical care and provide support and advice to patients regarding their physical and social needs. A weekly outpatient clinic is available, with daily treatments provided in the day ward.14 The service works in close partnership with Our Lady’s Children’s Hospital, Crumlin (OLCHC), which offers specialised care for children with sickle cell disease and thalassaemia in Ireland. When young patients reach the age of 16-to-18, their care is transferred to the adult service. This transition is supported by a monthly clinic at OLCHC, giving young people the chance to meet the adult care team. The clinic also helps them begin taking more responsibility for managing their condition as they move into adult life.14

Psychosocial impact and quality-of-life Sickle cell disease has profound social and psychological impacts on affected individuals and their families, with a sense of stigma and fear still common. Managing the disease and its complications can be particularly challenging for patients, caregivers, and healthcare providers. The unpredictable nature of sickle cell disease, including recurrent pain, hospitali-

The psychosocial burden of sickle cell disease extends to employment and personal independence in adulthood, often limiting career opportunities and affecting economic stability. Adapting psychologically to living with sickle cell disease depends on several factors, including family dynamics, social support systems, community inclusion, personality traits, and access to care and information. For individuals from minority backgrounds, additional social and systemic challenges may further complicate adjustment.1,2,3,9 Psychosocial support, disease education, emotional counselling, and opportunities for peer interaction can all play vital roles in helping individuals with sickle cell disease cope more effectively. Encouragement, reassurance, and structured interventions tailored to the patient’s environment and life stage can significantly enhance psychological resil-

Conclusion Sickle cell disease is a complex, systemic disorder, which can place a substantial medical, social and financial burden on patients, their families and their carers.

Although survival rates have improved with comprehensive care and therapy, disease-related complications continue to impact quality-of-life and functional outcomes. The development of novel agents targeting specific molecular pathways and the introduction of gene therapy mark a paradigm shift in the management of sickle cell disease. Future efforts should focus on improving global access to existing therapies, ensuring safe and equitable deployment of curative treatments, and addressing the psychosocial dimensions of care.

World Sickle Cell Disease Awareness Day takes place on June 19.

the EU: The ERN-EuroBloodNet perspective.

Lancet Haematol. 2023;10(8): e687-94 5. Sundd P, Gladwin M, Novelli E. Pathophysiology of sickle cell disease. Annu Rev Pathol. 2019; 14:263-92 6. Inusa B, Hsu L, Kohli N, Patel A, OminuEvbota K, Anie K, et al. Sickle cell disease – genetics, pathophysiology, clinical presentation, and treatment. Int J Neonatal Screen. 2019; 5(2), p.20 7. Tebbi C. Sickle cell disease: A review.

Haemato. 2022;3(2):341-66 8. Health Service Executive (HSE). Blood tests offered in pregnancy. HSE; 2023.

Available at: www2.hse.ie/pregnancybirth/scans-tests/blood-tests/bloodtests-offered/ 9. Spurway A, George S, Thompson C, Weeks S. Sickle cell disease: Causes, treatments, and the patient experience.

Pharm J. 2024 Jan 9 10. Brandow A, Liem R. Advances in the diagnosis and treatment of sickle cell disease. J Haematol Oncol. 2022; 15:20 11. Frangoul H, Altshuler D, Cappellini M, et al. CRISPR-Cas9 gene editing for sickle cell disease and β-thalassemia. N Engl J Med. 2021;384(3):252-260

12. Ledford H. CRISPR gene therapy shows promise against blood diseases. Nature.

2020 Dec;588(7838):383 13. UK All-Parliamentary Group on Sickle Cell and Thalassaemia. No one’s listening: An inquiry into the avoidable deaths and failures of care for sickle cell patients in secondary care. 2019. Available at: www.sicklecellsociety. org/wp-content/uploads/2021/11/No-OnesListening-Final.pdf 14. St James’s Hospital Dublin. (2025).

Sickle Cell and Thalassaemia. Available at: www.stjames.ie/services/hope/ sicklecellandthalassaemia/

fondaparinux sodium

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

Treatment of Acute Coronary Syndrome1

2.5 mg

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Active clinically significant bleeding.

Acute bacterial endocarditis.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Email: enquiry.ire@viatris.com.

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

fondaparinux sodium

24

THE MEDICAL INDEPENDENT | 3 JUNE 2025

Clinical Haematology

Statin usage may reduce death rate in leukaemia

P

atients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who were taking cholesterol-lowering statin medications at the start of their oncology treatment had a 61 per cent lower risk of dying from their cancer compared to similar patients who were not taking statins, according to a study published recently in the journal Blood Advances.

“This is the first systematic evaluation of the association of statin use with survival outcomes in patients with CLL or SLL who have been treated with contemporary targeted agents such as ibrutinib,” said the study’s principal investigator Dr Ahmad Abuhelwa, PhD, an assistant Professor of Pharmacy Practice and Pharmacotherapeutics at the University of Sharjah in the United Arab Emirates.

“Our results highlight a strong link between statin use and improved survival in this patient population.”

Study details Previous studies have linked statin use to reduced death rates from several cancers, including CLL, said Dr Abuhelwa. However, those studies did not evaluate the effects of statin use in patients who were treated with newer cancer therapies such as the targeted drug ibrutinib, he said.

In the current study, Dr Abuhelwa and his colleagues analysed data from 1,467 patients with CLL or SLL who participated in four international clinical trials conducted between 2012 and 2019.

In these trials, patients were randomly assigned to treatment with ibrutinib either alone or in combination with other anti-cancer drugs, or to a drug regimen that did not include ibrutinib. A total of 424 patients (29 per cent) were taking a statin at the time they started treatment across the four clinical trials. The median patient age was 65, and two-thirds (66 per cent) were men; 92 per cent had CLL, which was either newly diagnosed, had recurred, or had not responded to prior treatment.

The study’s primary endpoints were cancer-specific survival, overall survival, and progression-free survival. The secondary endpoint was the proportion of patients who experienced severe or life-threatening adverse events. The median follow-up time for all patients enrolled in the four trials was five years for overall survival and 22 months for progression-free survival.

To account for potential confounding factors, the investigators adjusted their analysis for variables including each patient’s diagnosis, age, sex, weight, physical functioning, disease severity, length of time since their diagnosis, number of co-existing illnesses, use of other medications for heart conditions or high blood pressure, and the specific anti-cancer treatment regimen received.

Credit: istock.com/sittithat tangwitthayaphum

Results Results showed that, regardless of any of these factors, patients who took a statin had, on average, a 61 per cent reduced risk of dying from their cancer, a 38 per cent reduced risk of death from any cause, and a 26 per cent reduced risk of disease progression. Importantly, statin use did not increase the likelihood of severe or life-threatening adverse events.

“These findings don’t allow us to say for certain that statins directly improve cancer outcomes,” acknowledged Dr Abuhelwa.

“However, the fact that this association remained strong even after accounting for multiple factors makes it an important area for future research.”

As next steps, he recommended conducting laboratory studies to better understand how statins may influence cancer biology, as well as prospective clinical trials in which patients with CLL or SLL are randomly assigned to take a statin or not.

Limitations The study has several limitations given its observational nature. For example, patients enrolled in clinical trials tend to be monitored more closely than those who receive treatment outside of a clinical trial, so the study findings may not be generalisable to patients treated in non-clinical trial settings. Additionally, because patients used various statins at different doses, the study could not determine the effects of specific statin types, doses, or duration of use on patients’ survival.

“While our results are very promising, we can’t recommend starting statins for CLL/SLL treatment based on this study alone,” Dr Abuhelwa said.

“Future clinical trials are needed to determine definitively whether statins have a direct benefit on cancer survival.”

Our results highlight a strong link between statin use and improved survival in this patient population

PRESCRIBING INFORMATION 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 official 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 efficacy of rezafungin has only been evaluated in a limited number of neutropenic patients.

Hepatic effects: 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 effect of rezafungin on human fertility are available. Rezafungin did not affect fertility in female rats or reproductive performance in male rats, despite reversible testicular effects in male rats. Side effects: 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 effect 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

Promotional content for ROI HCPs only ® REZZAYO is a Registered Trademark of Napp Pharmaceutical Group Limited, a Mundipharma network company.

Job Code: IE-RZF-2500011 | March 2025

THE MEDICAL INDEPENDENT | 3 JUNE 2025

26

Clinical Haematology Sickle cell disease research

Children taking hydroxyurea visited emergency department less, had fewer hospital days – study

H

ydroxyurea remains effective long-term in reducing emergency department visits and hospital days for children living with sickle cell disease, according to new research published in Blood Advances.

“This is one of the first large, real-world, long-term studies to assess the efficacy of hydroxyurea outside of a controlled setting,” said study author Dr Paul George, a paediatric haematology/oncology Fellow and PhD candidate at Emory University School of Medicine and Aflac Cancer and Blood Disorders Centre at Children’s Healthcare of Atlanta, US. “Our results reinforce that hydroxyurea, the most efficacious medicine available for sickle cell disease, continues to have really important benefits over time for paediatric patients.”

Sickle cell disease is the most common inherited red blood cell disorder in the world. According to the US Centre for Disease Control and Prevention, sickle cell disease affects one out of every 365 Black or African American births and one out of every 16,300 Hispanic American births.

Hydroxyurea, an oral, once-daily, and typically lifelong medication, reduces the frequency and severity of sickle cell disease pain crises, in addition to decreasing the need for blood transfusions, improving anaemia, and reducing the risk of acute chest syndrome, when abnormally shaped blood cells block vessels in the lungs. Currently, in the US, the National Heart, Lung, and Blood

Institute recommends that hydroxyurea be offered as a therapy to every patient with the more severe variant of sickle cell disease, HbSS/HbSβ0 starting between nineto-12 months of age.

“Hydroxyurea has been a mainstay in sickle cell disease treatment for a long time, but was initially used as a chemotherapy, so there have always been some lingering fears about its safety and efficacy, especially for children,” said study author Prof Wilbur Lam, a Professor of Paediatrics and biomedical engineering at Emory University and at the Georgia Institute of Technology, and a Paediatric Haematologist at Children’s Healthcare of Atlanta. “This study can provide some reassurance to patients and their families that this therapy, one of the most accessible for sickle cell disease, continues to be a safe option with a true benefit outside of a controlled setting.”

The study’s total cohort was made up of 2,147 children under the age of 18. All participants had the HbSS/ HbSβ0 variant of sickle cell disease, had more than three clinical encounters between 2010 and 2021 at Children’s Hospital of Atlanta, and had not received a bone marrow transplant, gene therapy, chronic transfusion therapy, or treatment with disease-modifying medications outside of hydroxyurea. Of the 2,147 participants, 1,240 (58 per cent) had used hydroxyurea; of those, the average time on hydroxyurea was 5.1 years, with 304 children aged eight or older on continuous hydroxyurea therapy.

The researchers found that, generally, children using

Menstrual cycle may contribute to sickle cell disease pain crises

A

marker linked to inflammation, C-reactive protein, may increase significantly during the follicular phase of the menstrual cycle in female patients with sickle cell disease, according to emerging research published in Blood Vessels, Thrombosis & Haemostasis. This observation provides insight into the pattern of painful vaso-occlusive events (VOEs), driven by inflammation, in female patients with the disorder.

“We know both from the literature and anecdotally from our patients that women with sickle cell disease have VOEs that cluster around their menstrual periods. We wanted to examine the potential reason behind that,” said the study’s lead author, Dr Jessica Wu, a resident physician in the Department of Obstetrics and Gynaecology at the Perelman School of Medicine at the University of Pennsylvania, US. “Our study is the first to examine the association between menstrual cycles and inflammation in female patients with sickle cell disease.”

“The menstrual cycle is often overlooked in research and clinical care, but can interact with health in important ways, as we are seeing in sickle cell disease,” said the study’s principal investigator, Dr Andrea Roe, an Assistant Professor of Obstetrics and Gynaecology at the Perelman School of Medicine at the University of Pennsylvania.

Dr Wu, Dr Roe, and their colleagues analysed plasma samples in the Penn Medicine BioBank repository from individuals with a confirmed sickle cell disease diagnosis. After excluding samples from participants who were pregnant, hospitalised with a VOE, or treat-

ed at an emergency department or infusion centre at the time of sample collection, 31 plasma samples were included in their analysis – 13 from female patients and 18 from male patients.

Previous literature has shown that female patients with sickle cell disease have more frequent, severe VOEs, often around the time of their menstrual periods.

The researchers measured C-reactive protein in all samples and female sex hormones, including oestradiol, progesterone, and luteinising hormone, in samples from female patients. They compared C-reactive protein, clinical laboratory markers, and other biomarkers by patient sex, sickle cell disease genotype, hydroxyurea use, and, in the cases of the 13 female patients, made the same comparisons between samples from the follicular and luteal phases of the menstrual cycle. A progesterone level of 1.75ng/mL was used to define the occurrence of ovulation and cut-off between the follicular and luteal phases.

Among the 31 samples, the average concentration of C-reactive protein was 4.45mg/L, with no significant differences observed based off sickle cell disease genotype or treatment with hydroxyurea. When Dr Wu and her colleagues compared C-reactive protein between samples from female patients and male patients, they observed no significant difference (3.88 vs 4.45mg/L, p=0.89); however, when they compared C-reactive protein between samples taken during the follicular or luteal phases of the female patients, they observed higher median C-reactive protein in the follicular phase versus the luteal phase (8.80 vs 0.82mg/L, p=0.03).

“The amount of inflammation is significantly elevated

hydroxyurea visited the emergency department less (0.36 fewer visits per patient-year) and spent fewer days in the hospital (0.84 fewer days per patient-year) across prolonged use when compared to children not on hydroxyurea. These results remained consistent even when the researchers accounted for disease severity and adherence by including only patients who began hydroxyurea at age one – before severe symptoms typically emerge – and limiting the sample to patients with laboratory markers that indicated consistent medication intake.

“Overall, hydroxyurea remained effective over time in these children,” said Dr George. “However, one important takeaway from this study is that improvements in haemoglobin concentration – or reductions in anaemia – were seen only in patients whose data indicated they were regularly taking the medication.” Dr George added that these results reflect real-world use and point to a continued need for providers to emphasize to patients the importance of taking hydroxyurea every day.

The researchers cautioned that the study does have some data limitations due to its real-world nature, including the reliance on laboratory markers to determine hydroxyurea adherence and lack of data on intermittent transfusions and acute events causing ongoing anaemia, such as pain crises. They hope to make up for these gaps in data in future studies and incorporate patient-reported outcomes to better gauge how hydroxyurea impacts children outside of the hospital setting.

in the follicular phase, or first half, of the menstrual cycle in female patients with sickle cell disease,” said Dr Wu. “This observation correlates with what we see in the literature; that this is the time in which this patient population has the most VOEs.” These results also mirror the trend seen in the menstrual cycles of the general population, though the magnitude of elevation is much greater in female patients with sickle cell disease than in those without sickle cell disease during the follicular phase (8.80mg/L vs 0.74mg/L). The significant fluctuation of C-reactive protein in female patients with sickle cell disease could have clinical implications given the similar temporal pattern of VOEs, providing a target for intervention.

“Many hormonal contraceptives can suppress menstruation or suppress the hormone fluctuations that occur from cycle to cycle, so contraceptives could help these patients manage their pain crises,” said Dr Wu. “Sickle cell disease is a really debilitating and painful disease. The more data we have about how it presents in female patients, the better we can counsel them on anticipating and managing their pain.”

Dr Wu cautioned that this research is still early and has several limitations, including its small sample size and cross-sectional, retrospective nature. Specifically, since each sample was from a singular time point in different individuals, menstrual phase comparisons in C-reactive protein (follicular vs luteal phase) were unable to be performed within the same individual. Additionally, because VOEs evolve through different stages, the researchers could not confirm that the subjects were at their baseline inflammatory levels, even if they did not have symptoms of an acute VOE. The researchers intend to validate their findings through further prospective studies with larger sample sizes and plan to explore menstrual patterns of other biomarkers associated with sickle cell disease, as well as correlation with clinical symptoms.

Scan to find Scan to find out more out more

TheThe first-and-only subcutaneous first-and-only subcutaneous continuous levodopa-based continuous levodopa-based therapy forfor patients with therapy patients with 1 advanced Parkinson’s disease advanced Parkinson’s disease1

Now Nowthey theycan can

more. more.

More refers to “On” time compared oralimmediate-release immediate-release(IR) (IR) levodopa/carbidopa. levodopa/carbidopa.11** More refers to “On” time compared totooral ® * Patients in the Produodopa study experiencedsignificant significantimprovements improvements compared compared with * Patients in the Produodopa study experienced with oral oral IR IR 1,2 levodopa/carbidopa at Week 12, including “On” time without troublesome dyskinesia and “Off” time. levodopa/carbidopa at Week 12, including “On” time without troublesome dyskinesia and “Off” time.1,2 ®

Produodopa® (foslevodopa/ foscarbidopa) 240 mg/ml + 12 mg/ml solution for infusion Please refer to the Summary of Product Produodopa® (foslevodopa/ foscarbidopa) 240 mg/ml + 12 mg/ml for infusion referand to 120 themgSummary of 1Product Characteristics (SmPC) before prescribing.

PRESENTATION: Each 10solution ml vial contains 2400 mgPlease foslevodopa foscarbidopa. ml contains Characteristics before PRESENTATION: Eachand 10 ml vial contains mg foslevodopa 120 mg foscarbidopa.

1 ml contains 240 mg(SmPC) foslevodopa andprescribing.

12 mg foscarbidopa.

Foslevodopa foscarbidopa are2400 prodrugs equivalent toand approximately 170 mg levodopa and 9 mg 240 mg foslevodopa and 12 mg foscarbidopa.

Foslevodopa and foscarbidopa are prodrugs equivalent to approximately 170 mg levodopa and 9 mg or carbidopa per 1 ml. INDICATION: Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia carbidopadyskinesia per 1 ml. INDICATION: Treatment of advanced levodopa-responsive Parkinson’ disease severe motor fluctuations and hyperkinesia or when available combinations of Parkinson medicinal products haves not givenwith satisfactory results.

DOSAGE AND ADMINISTRATION: dyskinesiaPosology: when available combinations of Parkinson medicinalsubcutaneous products have not given satisfactory results. DOSAGE ADMINISTRATION: Produodopa is administered as a continuous infusion, preferably in the abdomen, 24 hoursAND per day.

The recommended Posology:starting Produodopa administered as aiscontinuous infusion, preferably the abdomen, hours per (LE) day.and Thethen recommended infusionis rate of Produodopa determinedsubcutaneous by converting the daytime levodopainintake to levodopa24equivalents increasing it to starting infusion Produodopa is determined by converting the daytime levodopa to to levodopa equivalents (LE) that andmaximises then increasing it to accountrate for aof24-hour administration (see Initiation of treatment).

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The per maximum recommended dose of foslevodopa is 6000 (or 25 of ml“Off” of Produodopa per day approximately 4260 mg levodopa day). Produodopa replaces medications andof catechol-O-methyl transferase If required, other classes medicinal products daily doselevodopa-containing of foslevodopa is 6000 mg (or 25 ml Produodopa per day equivalent(COMT)-inhibitors. to approximately 4260 mg levodopa per day).ofProduodopa replaces for Parkinson’s disease can beand taken concurrently. Initiation of treatment: Patients selected for treatment with Produodopa should be capable levodopa-containing medications catechol-O-methyl transferase (COMT)-inhibitors.

If required, other classes of medicinal products for of using concurrently. the delivery system themselves or with Patients assistance from a for caregiver.

Patients be trained on be thecapable proper use Parkinson’understanding s disease can and be taken Initiation of treatment: selected treatment with should Produodopa should of of Produodopa and the (seethemselves Method of administration) prior to initiating treatment with Produodopa as necessary, thereafter. understanding and using thedelivery deliverysystem system or with assistance from a caregiver.

Patients should be and, trained on the proper use Three of steps initiate(see treatment Produodopa: Step 1: Calculate thetreatment LE based with on the levodopa-containing medications used during Produodopa andare therequired deliverytosystem Methodwith of administration) prior to initiating Produodopa and, as necessary, thereafter.

Three the s awake time.treatment Step 2: Determine the hourly infusion rate of Produodopa.

Step on 3: Determine the volume of themedications loading dose.used Referduring to Section steps are patient’ required to initiate with Produodopa: Step 1: Calculate the LE based the levodopa-containing the 4.2 of the SmPC for further information.

Method of administration: For administration of Produodopa onlyofthetheVyafuser used (refer patient’s awake time. Step 2: Determine the hourly infusion rate of Produodopa.

Step 3: Determine the volume loadingpump dose.should Refer tobeSection 4.2 to thefor pump instructions for use for details) using sterile, single-use infusion components (syringe, set, andpump vial adapter) qualified for use.toThe of the SmPC further information.

Method of administration: For administration of Produodopa onlyinfusion the Vyafuser should be used (refer are for useusing only.sterile, Once the content ofinfusion a vial iscomponents transferred into the syringe, theset, contents of the syringequalified should be the pump medication instructionsvials for use forsingle details) single-use (syringe, infusion and vial adapter) foradministered use. The within 24 hours. Refer to SmPC for details. Special populations: The pharmacokinetics of Produodopa has not been evaluated in any special medication vials are for single use only. Once the content of a vial is transferred into the syringe, the contents of the syringe should be administered population. Produodopa is intended for use in Parkinson’s disease patients who are already on a stable dose of oral levodopa. Elderly: The impact of within 24 hours. Refer to SmPC for details. Special populations: The pharmacokinetics of Produodopa has not been evaluated in any special age on the levodopa pharmacokinetics following Produodopa infusion was not specifically evaluated. Studies with levodopa suggest a modest population. Produodopa is intended for use in Parkinson’s disease patients who are already on a stable dose of oral levodopa. Elderly: The impact of reduction of levodopa clearance with increasing age. Paediatric: Safety in patients under 18 years has not been established and its use in patients age on thebelow levodopa pharmacokinetics following Produodopa infusion was not specifically evaluated. Studies with levodopa suggest a modest the age of 18 is not recommended. Renal/hepatic impairment: The pharmacokinetics of Produodopa in subjects with renal and/or hepatic reduction impairment of levodopahas clearance with increasingCaution age. Paediatric: Safety in patients under years hasRenal not been established its use treatment in patientswith not been established. should be exercised in patients with18End Stage Disease on dialysisand requiring below theProduodopa age of 18 is because not recommended.

Renal/hepatic impairment: The pharmacokinetics of Produodopa inHypersensitivity subjects with renal and/or hepatic or of diminished ability of the kidneys to eliminate phosphate. CONTRAINDICATIONS: to active substances impairment has not narrow-angle been established.

Caution should befailure exercised in patients with End Diseasewhere on dialysis requiring treatment with(e.g. excipients, glaucoma, severe heart or cardiac arrhythmia, acuteStage stroke.Renal Conditions adrenergics are contraindicated Produodopa because of diminished ability of the kidneys to eliminate phosphate.MAO-inhibitors CONTRAINDICATIONS: Hypersensitivity to activeare substances or pheochromocytoma, hyperthyroidism, Cushing’ s syndrome).

Non-selective and selective MAO type A inhibitors contraindicated excipients,and narrow-angle glaucoma,atsevere heart failure or cardiac acute stroke. Conditions are contraindicated (e.g. must be discontinued least two weeks before startingarrhythmia, Produodopa.

Produodopa should not where be usedadrenergics in patients with suspicious undiagnosed pheochromocytoma, Cushing’SPECIAL s syndrome).

Non-selective MAO-inhibitors and warnings selective and MAOprecautions type A inhibitors aregeneric contraindicated skin lesions hyperthyroidism, or a history of melanoma.

WARNINGS AND PRECAUTIONS: Several below are for levodopa and must and, be discontinued at for least two weeksNot before starting Produodopa.

Produodopa should not be usedCaution in patients with pulmonary suspicious or undiagnosed therefore, also Produodopa. recommended for drug-induced extrapyramidal reactions. in severe cardiovascular skin lesions or a history of melanoma.

SPECIAL AND PRECAUTIONS: warnings andorprecautions below are generic for levodopa disease, bronchial asthma, renal, hepaticWARNINGS or endocrine disease, or history ofSeveral peptic ulcer disease of convulsions, chronic wide-angle glaucoma. In patients history of myocardial infarction who have residual atrial nodal or ventricular arrhythmias, should be monitored with and, therefore, alsowith for aProduodopa.

Not recommended for drug-induced extrapyramidal reactions.

Caution incardiac severefunction pulmonary or cardiovascular care during initial dose Monitor alldisease, patientsorforhistory development of ulcer mentaldisease changes, with chronic suicidal wide-angle tendencies and other serious disease, bronchial asthma, renal,adjustments. hepatic or endocrine of peptic or depression of convulsions, glaucoma.

In mental changes, past or current psychosis shouldresidual be treated caution.

Higher frequency of hallucinations can should occur inbepatients treated patients with a history of myocardial infarction who have atrialwith nodal or ventricular arrhythmias, cardiac function monitored withwith dopamine agonists and/or Monitor other dopaminergic treatments containing levodopa including Produodopa.

Review of treatment recommended care during initial dose adjustments. all patients for development of mental changes, depression with suicidal tendencies and other serious if symptoms develop.

Co-administration of antipsychotics with dopamine receptor blocking of properties should be with caution.

Produodopa mental changes, past or current psychosis should be treated with caution. Higher frequency hallucinations cancarried occurout in patients treated with induceand/or orthostatic therefore, cautioncontaining in co-administrating products which mayReview cause orthostatic hypotension.

A symptom dopaminemay agonists otherhypotension, dopaminergic treatments levodopa with including Produodopa. of treatment recommended if complex resembling Neuroleptic Malignant Syndrome (NMS), including muscular rigidity, increased body temperature, mental changes symptoms develop. Co-administration of antipsychotics with dopamine receptor blocking properties should be carried out with caution. Produodopa(e.g., agitation, confusion, coma) and increased serum creatine phosphokinase, has been reported when anti-Parkinsonian medicinal products were may induce orthostatic hypotension, therefore, caution in co-administrating with products which may cause orthostatic hypotension. A symptom withdrawn abruptly.

Rhabdomyolysis secondary (NMS), to NMSincluding or severe muscular dyskinesiasrigidity, have been observed rarely in patientsmental with Parkinson’ disease. complex resembling Neuroleptic Malignant Syndrome increased body temperature, changess (e.g., Therefore, patients should be carefully observed when the dose of levodopa/carbidopa combinations are abruptly reduced or discontinued, agitation, confusion, coma) and increased serum creatine phosphokinase, has been reported when anti-Parkinsonian medicinal products were especially if the patient is receiving antipsychotics. Neither NMS nor rhabdomyolysis has been reported in association with Produodopa. Periodically withdrawn abruptly. Rhabdomyolysis secondary to NMS or severe dyskinesias have been observed rarely in patients with Parkinson’s disease. evaluate hepatic, haematopoietic, cardiovascular and renal function during extended therapy. Increases in impulse control disorders have been Therefore, patients should be carefully observed when the dose of levodopa/carbidopa combinations are abruptly reduced or discontinued, reported and patients should be monitored and reviewed. Patients and providers are advised to monitor for melanomas on a regular basis when using especiallyProduodopa. if the patientIdeally, is receiving antipsychotics. Neither NMS nor rhabdomyolysis has been reported in association with Produodopa. Periodically periodic skin examinations should be performed by dermatologists. Dose may need to be adjusted downwards to avoid levodopa evaluate hepatic, cardiovascular and renal function during extendedantherapy.

Increases in impulse control disorders have been induced haematopoietic, dyskinesia. Sudden or gradual worsening of bradykinesia may indicate obstruction in the device and should be investigated.

Produodopa reported and patients should be monitored and reviewed. Patients and providers are advised to monitor for melanomas on a regular basis when using Produodopa. Ideally, periodic skin examinations should be performed by dermatologists. Dose may need to be adjusted downwards to avoid levodopa induced dyskinesia. Sudden or gradual worsening of bradykinesia may indicate an obstruction in the device and should be investigated. Produodopa

contains hydrazine, a degradation product of foscarbidopa that can be genotoxic and probably carcinogenic, clinical significance of exposure is contains hydrazine, a degradation productpatients of foscarbidopa that can be genotoxic probably carcinogenic, clinical Dopamine significance of exposure is unknown.

Before initiation of treatment, and caregivers should be warnedand of the potential risk of developing Dysregulation unknown.

Before of treatment, patients and caregivers should with be warned of the potential risk of developing Dopamine Dysregulation Syndrome (DDS).initiation Polyneuropathy has been reported in patients treated levodopa/carbidopa containing products. Before starting therapy Syndrome has of been reported in and patients with levodopa/carbidopa containing products. therapy evaluate(DDS). patientsPolyneuropathy for history or signs polyneuropathy knowntreated risk factors, and periodically thereafter.

Reduced ability toBefore handlestarting the delivery evaluate patients for history or signs of polyneuropathy and known risk factors, and periodically thereafter.

Reduced ability to handle the delivery system can lead to complications, in such case assistance should be provided. Infusion site events have been reported in patients receiving system can lead to complications, in suchwhile caseusing assistance should be Infusionofsite events have reported into patients Produodopa.

Following aseptic techniques this medication andprovided. frequent rotation the infusion site arebeen recommended reduce thereceiving risk.

Produodopa.

Following techniques while using this medication and diet. frequent rotation of the sitestudies are recommended to reduce with the risk.

Produodopa is high inaseptic sodium, to be considered in patients on a low salt INTERACTIONS: Noinfusion interaction have been performed Produodopa is high sodium,interactions to be considered in patients on generic a low salt diet. INTERACTIONS: No interaction studies been Produodopa.

The in following are known from the combination of levodopa/carbidopa.

Caution is have needed in performed concomitantwith Produodopa.

Theoffollowing interactions are known from the generic combination oftricyclic levodopa/carbidopa. is needed concomitant administration Produodopa with the following medicinal products: antihypertensives, antidepressants,Caution dopamine receptor in antagonists, administration of Produodopa with the following medicinal products: antihypertensives, tricyclic antidepressants, antagonists, benzodiazepines, isoniazid, phenytoin, papaverine, sympathomimetics (may increase cardiovascular adverse eventsdopamine related toreceptor levodopa), COMT inhibitors (e.g. tolcapone, entacapone,papaverine, opicapone),sympathomimetics amantadine (may increase levodopa related adverse events).

An adjustment the dose COMT of benzodiazepines, isoniazid, phenytoin, (may increase cardiovascular adverse events related to oflevodopa), Produodopa may be needed.

Foscarbidopa has been identified as a potential of CYP1A2 vitro. Care shouldAn be adjustment taken when of prescribing inhibitors (e.g. tolcapone, entacapone, opicapone), amantadine (may increaseinducer levodopa relatedinadverse events). the dose of Produodopa in be combination with sensitivehas CYP1A2 (e.g., fluvoxamine, clozapine, caffeine, theophylline, duloxetine melatonin).

Produodopa may needed. Foscarbidopa been substrates identified as a potential inducer of CYP1A2 in vitro.

Care should be takenand when prescribing Produodopainmay be administered concomitantly withsubstrates the manufacturer’ s recommended dose of acaffeine, MAO inhibitor with selectivity for MAOand typemelatonin).

B (e.g., Produodopa combination with sensitive CYP1A2 (e.g., fluvoxamine, clozapine, theophylline, duloxetine selegiline HCl).

Theadministered dose of Produodopa may need to the be reduced when as recommended MAO inhibitor selective typeinhibitor B is added.

Produodopa may be concomitantly with manufacturer’ dose of for a MAO withFERTILITY, selectivityPREGNANCY for MAO typeAND B (e.g., LACTATION: not recommended during pregnancy in women childbearing potential not Busing contraception unless the benefitsAND selegiline HCl). Produodopa The dose of isProduodopa may need to be reducedand when a MAO of inhibitor selective for type is added.

FERTILITY, PREGNANCY for the mother outweigh the possible risks to the foetus.

Breast-feeding should be discontinued during treatment with Produodopa.

In reproduction LACTATION: Produodopa is not recommended during pregnancy and in women of childbearing potential not using contraception unless the benefits no effects on fertility were observed in rats receiving levodopa/carbidopa.

TO DRIVE ANDtreatment USE MACHINES: ProduodopaIncan have a for studies, the mother outweigh the possible risks to the foetus.

Breast-feeding should beABILITY discontinued during with Produodopa. reproduction majorno influence on fertility the ability to drive and use machines.

May cause dizziness or orthostatic exercise caution.

Refrain studies, effects on were observed in rats receiving levodopa/carbidopa.

ABILITY TOhypotension, DRIVE ANDtherefore USE MACHINES: Produodopa canfrom have a driving/operating machinery if somnolence and/or sudden sleep episodes occur. UNDESIRABLE EFFECTS: Very common (≥1/10): infusion site major influence on the ability to drive and use machines. May cause dizziness or orthostatic hypotension, therefore exercise caution. Refrain from cellulitis, infusion site infection, anxiety, depression, hallucination, infusion site erythema, infusion site reaction, infusion site nodule, infusion site driving/operating machinery if somnolence and/or sudden sleep episodes occur. UNDESIRABLE EFFECTS: Very common (≥1/10): infusion site oedema, infusion site pain, fall. Common (≥1/100 to <1/10): infusion site abscess, decreased appetite, confusional state, delusion, impulse control cellulitis, infusion site infection, anxiety, depression, hallucination, infusion site erythema, infusion site reaction, infusion site nodule, infusion site disorder, insomnia, paranoia, psychotic disorder, suicidal ideation, cognitive disorder, dizziness, dizziness postural, dyskinesia, dystonia, headache, oedema, infusion site pain, Common (≥1/100 to <1/10): infusion sitesomnolence, abscess, decreased appetite, confusional state,orthostatic delusion, hypotension, impulse control hypoaesthesia, on and offfall. phenomenon, paraesthesia, polyneuropathy, syncope, hypertension, hypotension, disorder, insomnia, paranoia, disorder, suicidal cognitive disorder,pruritus, dizziness, dyskinesia, dystonia, urinary headache, dyspnoea, abdominal pain,psychotic constipation, diarrhoea, dry ideation, mouth, nausea, vomiting, rash,dizziness muscle postural, spasms, urinary incontinence, hypoaesthesia, on andfatigue, off phenomenon, paraesthesia, polyneuropathy, somnolence, hypertension, hypotension, orthostatic hypotension, retention, asthenia, infusion site bruising, infusion site exfoliation, infusionsyncope, site extravasation, infusion site haematoma, infusion site dyspnoea, abdominal pain, diarrhoea, dry mouth, infusion nausea,site vomiting, muscle spasms, urinaryinfusion incontinence, urinary haemorrhage, infusion site constipation, induration, infusion site inflammation, irritation,pruritus, infusion rash, site mass, infusion site papule, site pruritus, retention, asthenia, fatigue, infusion site bruising, infusion site exfoliation, infusion site extravasation, infusion site haematoma, infusion infusion site rash, infusion site swelling, malaise, oedema peripheral, vitamin B6 decreased, weight decreased. The following adverse reactionssite haemorrhage, infusion induration, infusion site inflammation, infusion irritation, infusion mass, infusion site papule, site pruritus, were identified withsite Duodopa (levodopa/carbidopa) intestinal gel assitedrug-related events;site however, these events wereinfusion not considered infusion sitereactions rash, infusion site swelling,Very malaise, oedema peripheral, vitaminCommon: B6 decreased, weight decreased.

The following adverse adverse for Produodopa: common: urinary tract infection; anaemia, abnormal dreams, agitation, sleep attacks,reactions sleep were identified Duodopa (levodopa/carbidopa) as drug-related however, theseflatulence, events were not considered disorder, tremor,with heart rate irregular, oropharyngeal pain,intestinal abdominalgeldistension, dysgeusia,events; dyspepsia, dysphagia, dermatitis contact, adverse reactions for pain, Produodopa: Veryacid common: urinary tract infection; Common: anaemia, abnormal dreams,level agitation, sleepvitamin attacks,B12 sleep hyperhidrosis, neck pain, amino level increased (methylmalonic acid increased), blood homocysteine increased, deficiency, weight increased.

Laboratory values: The following laboratory abnormalities havedyspepsia, been reported with levodopa/carbidopa treatment disorder, tremor, heart rate irregular, oropharyngeal pain, abdominal distension, dysgeusia, dysphagia, flatulence, dermatitis contact, and should, therefore, be pain, acknowledged when treating patients with Produodopa: urea nitrogen, alkaline phosphatases, S-AST, S-ALT, LDH, B12 hyperhidrosis, neck pain, amino acid level increased (methylmalonic acidelevated increased), blood homocysteine level increased, vitamin bilirubin,weight blood sugar, creatinine, uric acidvalues: and positive Coomb’s test, and lowered values of haemoglobin and haematocrit.

Leucocytes, bacteria and deficiency, increased.

Laboratory The following laboratory abnormalities have been reported with levodopa/carbidopa treatment in the urine have been reported. Refer Section 4.8 of with the SmPC for details of other effects,alkaline and forphosphatases, further information.

LEGALLDH, andblood should, therefore, be acknowledged when to treating patients Produodopa: elevated ureaside nitrogen, S-AST, S-ALT, CATEGORY: (S1A).

MARKETING AUTHORISATION PA 1824/2/3 (7 x 10 values ml vials).ofMARKETING HOLDER: AbbViebacteria Limited,and bilirubin, bloodPOM sugar, creatinine, uric acid and positive NUMBER: Coomb’s test, and lowered haemoglobinAUTHORISATION and haematocrit.

Leucocytes, Citywest Campus, 24, Refer Ireland.toFurther information available on request from:side AbbVie Limited, Riverwalk, Business blood in theBusiness urine have been Dublin reported.

Section 4.8 of the isSmPC for details of other effects, and14for furtherCitywest information.

LEGAL Campus, Dublin 24, Ireland.

CATEGORY: POM (S1A).

MARKETING AUTHORISATION NUMBER: PA 1824/2/3 (7 x 10 ml vials). MARKETING AUTHORISATION HOLDER: AbbVie Limited, Citywest Business 24, Ireland.

Further information is available on request Limited, 14 Riverwalk, Citywest Business Adverse eventsCampus, should Dublin be reported.

Healthcare professionals are asked to reportfrom: anyAbbVie suspected adverse reactions via HPRA Campus, Dublin 24, Ireland.

Pharmacovigilance, website: www.hpra.ie.

Date ofevents Revision:should February PI/2/3/003.

Adverse be2024. reported.

Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, website: ® www.hpra.ie.

References: 1. Produodopa (foslevodopa/foscarbidopa solution for infusion) Summary of Product Characteristics, available on www.medicines.ie. 2. Soileau MJ, et al. Lancet Neurol. 2022; Date of Revision: February 2024. PI/2/3/003.

21:1099–1109 (incl. suppl.).

References: 1. Produodopa® (foslevodopa/foscarbidopa solution for infusion) Summary of IE-PRODD-240048 | Date of preparation: November 2024 Product Characteristics, available on www.medicines.ie.

2. Soileau MJ, et al. Lancet Neurol. 2022; 21:1099–1109 (incl. suppl.).

IE-PRODD-240048 | Date of preparation: November 2024

THE MEDICAL INDEPENDENT | 3 JUNE 2025

28

Conference Coverage ALL REPORTS NIAMH CAHILL

Irish Neurological Association, Annual Meeting, The Rose Hotel, Tralee, Co Kerry, 15-16 May 2025

Updates and developments in epilepsy treatment

T

he Irish Neurological Association (INA) 61st Annual Meeting, organised by the Irish Institute of Clinical Neuroscience, took place in Tralee, Co Kerry, last month.

Approximately 150 attendees gathered at the Rose Hotel on Thursday 15 May for the two-day meeting.

Proceedings began with INA President Dr Helena Moore delivering the opening address.

Following the address, Prof Norman Delanty, Consultant Neurologist, Beaumont Hospital, Dublin, provided a treatment update on important developments in epilepsy.

Prof Delanty outlined a number of new anti-seizure medications that are in development and have been approved for epilepsy.

He observed that cenobamate, a new anti-seizure medication, has shown benefits for patients with previously

Credit: istock.com

He also highlighted fenfluramine, a niche medication and serotonergic agonist, used in managing seizures associated with Dravet syndrome and Lennox-Gastaut syndrome

treatment-resistant epilepsy.

“It can be a very effective drug, but it can be a tricky drug to use and if a person is on multiple other drugs because they have a history of bad epilepsy, they need to proactively start reducing the medications,” according to Prof Delanty. “…. But it remains to be seen how broad spectrum cenobamate is. It probably is broad spectrum in a certain amount of patients,” he said.

He also highlighted fenfluramine, a niche medication and serotonergic agonist, used in managing seizures associated with Dravet syndrome and Lennox-Gastaut syndrome.

Recently approved for reimbursement under the HSE High-Tech Drug Scheme, the drug requires clinicians to

complete a registration and approval process before it can be prescribed.

“This is a very useful drug for patients with Dravet syndrome and Lennox-Gastaut syndrome,” he told delegates.

He went on to discuss another emerging treatment for complex epilepsy, zorevunersen.

Dravet syndrome is most often caused by loss-of-function mutations in one copy of the SCN1A gene, which encodes the Nav1.1 sodium channel essential for brain function. This results in reduced Nav1.1 levels (haploinsufficiency), leading to seizures and other symptoms.

Zorevunersen, an antisense oligonucleotide, works by increasing expression from the healthy SCN1A gene copy to restore Nav1.1 levels. It binds to specific RNA sequences, enhancing the gene's productivity and helping to correct the underlying protein deficiency.

“It has completed early clinical trials in 81 patients and the outcomes so far are very promising,” Prof Delanty said.

“The FDA [Federal Drug Administration in the US] have given Stoke Therapeutics the go ahead to do a multi-centre phase 3 regulatory trial. This is starting around now and will take two years. If this is positive and early indications are promising, we will have the first gene therapy for epilepsy.”

He also informed delegates that individuals of all ages with epilepsy are now eligible for a free travel pass if they are unable to drive or feel uncomfortable doing so. A consultant or GP can complete the necessary form to facilitate access to the pass, he explained.

Following his update, Prof Delanty chaired the session which focused on epilepsy and neurophysiology and featured several presentations.

Over the course of the two-day meeting, presentations were also delivered on a range of other topics, including multiple sclerosis, neurosurgery, movement disorders, and neuromuscular conditions.

An inclusive future for healthcare

T

he Noel Callaghan Guest Lecture at the Irish Neurological Association (INA) Annual Meeting was delivered by Prof Geraldine McGinty, Professor of Clinical Radiology and Population Health, Weill Cornell Medical

School, US. The title of her lecture was ‘An inclusive future for healthcare: Provider-driven, patient-powered, AI-enabled’.

INA President Dr Helena Moore welcomed Prof McGinty to the stage, noting their shared time as students in Galway before Prof McGinty's move to the US. She also paid tribute to Dr Noel Callaghan – the first neurologist appointed in Cork and a founding member of the INA – whose legacy the lecture commemorates.

A warm welcome was extended to Dr Callaghan’s daughter, Helen, and granddaughter, Ella, both of whom were in attendance for the occasion.

Prof McGinty, who trained as a radiologist in Pittsburgh, opened her lecture on the subject of inclusivity and detailed her work in trying to deliver positive change in the US healthcare system.

She outlined how the US provides the best medical care in the world “to some”, but not all, people.

Prof McGinty highlighted the stark contrast in life expectancy within New York City, noting that while residents of aff luent Manhattan live on average to 85 years, just 10 miles north in the less advantaged Bronx, the average drops to 75 years.

Prof Geraldine McGinty “We spend a lot of money on healthcare in the US, about 20 per cent of our national output, and yet our outcomes are often nothing to be proud of, especially if you’re from certain demographic groups. People of colour in the US have dramatically poorer outcomes....

And our incredibly complex payments system means

that the single most common cause of personal bankruptcy in the US is medical bills,” she said.

According to Prof McGinty, healthcare is most effectively delivered by teams – especially diverse ones.

“Physician-led hospitals, like the one I work in, do perform better… there is data that shows patients tend to have better experiences in those health systems,” Prof McGinty said, though she acknowledged that “it’s not something where there is P value”.

However, there is no doubt that if positive change is being sought in healthcare “we will not do it without the buy in and support of the doctors in that healthcare system”, she maintained.

Unfortunately, doctors do not necessarily think of themselves intuitively as healthcare leaders, she added, and they are not taught how to be leaders in medical school.

“There is a mythology there about being the smartest person in the room being the person who has to take the hard decisions,” she said. Prof McGinty also pointed out that relationships medical professionals “have with non-physicians and non-healthcare providers on our teams or who lead our systems” can be "fractured and fractious”. “So how do we get comfortable thinking about ourselves as leaders?,” she asked.

Continued on p30 

ADD ON TO LIFE

ONgentys® is indicated as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Taken OD at bedtime at least 1 hour before or after levodopa combinations.

Capsules should be swallowed whole with water.

Further prescribing information or the SmPC is available from: Athena Pharmaceuticals Ltd, 4045 Kingswood Rd, Citywest Business Campus, Dublin 24, Ireland. medical@ athenapharm.com. Tel +353 (1) 4688202. Legal Status: POM. Pack Size: 50mg pack of 30. Price on application.

MA no: EU/1/15/1066/003. MA Holder: Bial-Portela & Ca., S.A., A Avenida da Siderurgia nacional 4745-457 Coronado (S. Romao e S. Mamede) - Portugal.

Adverse events should be reported to: BIAL +44 (0) 1628 531171 or bial@pharmalex.com or Health Products Regulatory Authority www.hpra.ie e: medsafety@hpra.ie Tel +353 (1) 6764971.

Product Reference: ONG 11-24-76 Date of Preparation: November 2024

THE MEDICAL INDEPENDENT | 3 JUNE 2025

30

Conference Coverage Irish Neurological Association, Annual Meeting, The Rose Hotel, Tralee, Co Kerry, 15-16 May 2025



Continued from p28

According to Prof McGinty, the answer lies in greater self-awareness and team understanding – something that can begin with tools like personality assessments.

Pulling together teams of people who are different who can complement our skills can also help doctors drive change, she said.

“But we have to amplify the power of that diversity,” she stressed. Doctors can do this by fostering diverse teams and teams in which people feel comfortable “speaking up”.

Prof McGinty spoke about the importance of “psychological safety”, clarifying that it does not mean “everybody feels comfortable all the time”, but rather that a team unable to respectfully challenge one another cannot be truly effective.

Strong teams are built on the absence of fear, where problems and challenges can be openly acknowledged and discussed, she said.

Healthcare can often feel overwhelming due to its complexity and the multitude of stakeholder groups – each viewing the system through a different lens – which, she noted, can lead to friction.

Prof McGinty advised doctors to try to understand the levers of change in healthcare, particularly the “financial drivers” within health systems, in order to help foster change.

Prof McGinty concluded by urging healthcare professionals to reflect on their own readiness for change, especially in the aftermath of the Covid-19 pandemic.

While five years have passed since the beginning of the pandemic, the strain of physician and provider burnout remains a serious concern.

“We have to be thoughtful about our ability to pick ourselves up and make changes when we are feeling challenged by our day-to-day work,” she said.

She also pointed to evidence linking burnout to poorer clinical outcomes, including higher rates of surgical site infections and even mortality, as well as increased malpractice claims within healthcare systems.

She spoke about the “transformative” nature of mentorship – whether through career guidance, coaching, or psycho-social support.

“We need to take care of each other and ourselves,” she advised.

Prof McGinty then turned to the subject of patients, and the influential power they can have, both in a positive and negative way. Patients, she said, are the most

important stakeholder in healthcare.

She discussed the lack of trust among some communities in healthcare.

Prof McGinty noted, in particular, the level of distrust among the black community in the US following decades of inadequate care.

“We have a maternal mortality scandal in the US and what’s really unfortunate and telling is that even black women who have resources are at a much higher risk of dying in childbirth,” she said.

She noted the power of social media in disseminating disinformation, which needs to be counteracted, she argued.

Shifting focus to artificial intelligence (AI), Prof McGinty, a radiologist, noted the widespread belief that AI could replace radiologists However, she said, the majority of US radiologists are not using AI despite working in a specialty that “loves innovation”. AI adoption has been much slower in healthcare than initially envisioned.

Prof McGinty said there is a role for the technology, given the “severe workforce shortage” in radiology and “the volume of imaging” required due to ageing populations.

“There is ample evidence… that an algorithm can perform at least as well as me and, [speaking] candidly, at the end of the day, when I’m distracted… the algorithm can probably outperform me.”

However, she asked “why is it that after all this hype, we are not seeing AI not just replacing radiologists, but also featuring more prominently in how we deliver and transform healthcare?”.

We have to be thoughtful about our ability to pick ourselves up and make changes when we are feeling challenged by our day-to-day work

The complex nature of stakeholders in healthcare has played a role in limiting the adoption of AI in healthcare, she said.

She added that AI tools often seek to answer just one question or one part of a puzzle when several issues are usually at play in assessing patients.

Access to datasets used to train AI algorithms is another limitation, along with regulatory barriers in sharing data outside hospital systems, she said.

“Until we start to see more data being shared that is going to limit it [AI],” she told delegates.

“That’s not to say we are not using any AI in the US. There is a lot of AI happening informally in health systems and a lot of academic systems are developing their own algorithms.”

Prof McGinty remains excited, however, about the potential of AI in radiology imaging and in helping to alleviate radiology workforce shortage that exists not only in the US, but worldwide.

“What we are seeing is the ability of AI to extend what we do as imagers across areas where there are simply never going to be enough human imagers.”

Note-taking places a significant burden on providers, affecting both their time and wellbeing, she said.

AI-powered medical scribe tools can help ease this workload. She also emphasised that AI’s potential to streamline administrative tasks should not be underestimated. Additionally, AI could integrate siloed datasets to support more timely and accurate diagnoses.

However, she argued that significant concerns about the technology must be addressed. Prof McGinty questioned the potential negative effects of these innovations, warning against over-enthusiasm and stressing the importance of understanding how these imperfect tools operate. Among the key challenges she highlighted were AI bias – not just its presence, but the risk of amplifying existing societal biases – and misaligned incentives, which could further complicate responsible development and use.

“We have to be very clear when we consume information, when we make decisions, that we understand who is getting paid for what, and who is doing what for who, so we can… understand what the incentives are,” she advised.

Post-market monitoring and governance are critically important in AI and AI algorithms need to be attuned to the needs of all patients, she warned.

Despite the challenges, all tools, including AI, should be used by doctors to help change healthcare, Prof McGinty said.

High quality research recognised at neurology meeting

T

he Irish Neurological Association Annual Meeting 2025 recognised excellence in neurological research and clinical practice, with prizes awarded across a range of specialties including epilepsy, Parkinson’s disease, and neurosurgery.

The John Kirker Prize for the best epilepsy-related presentation went to ‘Epilepsy and women’s health – practice review in our regional epilepsy service’.

Dr Julie Sheehan presented the findings of the study to attendees.

The audit by doctors at St James’s Hospital, Dublin, and Trinity College Dublin examined the quality of

management of 320 women with epilepsy who attended clinics at St James’s Hospital in 2024.

The research highlighted deficiencies in the current practice for managing women with epilepsy.

Guidelines have not been updated “since the emergence of research relating to teratogenicity of specific anti-seizure medications, nor do they acknowledge the developments in women’s healthcare in Ireland, including in vitro fertilisation and medical termination of pregnancy”.

The audit concluded that there is a need for greater emphasis on women’s healthcare among people with epilepsy and advised that the lack of attention current-

ly paid to the area is “likely a reflection of the historical male bias in scientific literature.”

“A proactive approach is required to improve these knowledge gaps and overall care for female patients in neurology.”

Meanwhile, the John Lynch Prize for best poster presentation went to a study titled ‘Introduction of a pilot seizure pathway in Tallaght University Hospital’. The findings were presented by Dr Shamseela Waqar and Dr Farkhanda Qaiser.

Continued on p32 

PREVENT PREVENT PREVENT

1 1 THE DISRUPTION OF MIGRAINE THE DISRUPTION OF MIGRAINE 1

THE DISRUPTION OF MIGRAINE only oral once-daily TheThe only oral once-daily calcitonin gene-related peptide (CGRP) calcitonin gene-related (CGRP) The onlypeptide oral once-daily receptor antagonist both episodic receptor antagonist for for both episodic calcitonin gene-related peptide (CGRP) 1,2 1,2 chronic migraine patients andand chronic migraine patients receptor antagonist for both episodic and chronic migraine patients1,2

Tablet actual Tablet not not actual size.size.

Tablet not actual size.

Typical characteristics of migraine headache of unilateral location, pulsating quality, moderate or severe intensity, Typical characteristics of migraine are are headache of unilateral location, pulsating quality, moderate or severe intensity, 3 3 aggravation by routine physical activity association nausea and/or photophobia Typical characteristics of migraine are headache of unilateral location, pulsating quality, moderate or phonophobia. severe intensity, aggravation by routine physical activity andand association withwith nausea and/or photophobia andand phonophobia. aggravation by routine physical activity and association with nausea and/or photophobia and phonophobia.3

ABBREVIATED PRESCRIBING INFORMATION. AQUIPTA® (atogepant) mg tablets; mg tablets.

AND LACTATION: Pregnancy: Atogepant not recommended pregnancy in women of childbearing AND LACTATION: Pregnancy: Atogepant is notisrecommended duringduring pregnancy and inand women of childbearing ABBREVIATED PRESCRIBING INFORMATION. AQUIPTA® (atogepant) 10 mg10 tablets; 60 mg60 tablets.

PleasePlease refer refer the Summary of Product Characteristics (SmPC) before prescribing.

PRESENTATION: Each tablet contains: 10 potential not using contraception.

Breast-feeding: It is unknown whether atogepant is excreted in human potential using contraception.

Breast-feeding: It is unknown whether atogepant in childbearing human milk. milk. to thetoSummary of Product Characteristics (SmPC) before prescribing.

PRESENTATION: Each60tablet contains: 10 refer ABBREVIATED PRESCRIBING INFORMATION. AQUIPTA® (atogepant) 10 mg tablets; mg tablets.

Please AND not LACTATION: Pregnancy: Atogepant is not recommended during pregnancy andisinexcreted women of mg atogepant in 10 mgoftablet, mg atogepant in mg tablet.

INDICATION: Prophylaxis of migraine in adults A decision must becontraception. made whether to discontinue or toatogepant discontinue/abstain from therapy mg atogepant mg tablet, 60 mg60 atogepant in 60(SmPC) mg60 tablet.

INDICATION: Prophylaxis of migraine in adults A10 decision must be made whether to discontinue breast-feeding to discontinue/abstain fromintherapy taking to in the10Summary Product Characteristics before prescribing.

PRESENTATION: Each tablet contains: potential not using Breast-feeding: It isbreast-feeding unknownorwhether is excreted human milk. taking who at have at 4 migraine daysmonth. per DOSAGE AND The recommended dose is mg into account thebebenefit of breast-feeding forchild the childthe andbenefit the of therapy forwoman. the therapy woman.

Fertility: into account themust benefit of breast-feeding for the and of therapy for the Fertility: No No who have least 4least migraine days DOSAGE ANDinADMINISTRATION: The recommended dose is 60 mg mg atogepant in 10 mg per tablet, 60 month. mg atogepant 60 mgADMINISTRATION: tablet. INDICATION: Prophylaxis of migraine in 60 adults A decision made whether to discontinue breast-feeding or tobenefit discontinue/abstain from taking onceatwith daily with or without meals; swallowed andsplit, not crushed split, crushed or chewed.

Missed dose human data on the effect atogepant onfor fertility are and available.

Animal showed no impact on female who have leastor 4 without migraine days per month.

DOSAGE AND The dose is 60 mg into account benefit of of breast-feeding the child the benefit of studies therapy forno the woman.

No and human data on thethe effect of atogepant on fertility are available.

Animal studies showed impact onFertility: female and akentaken orally orally once daily meals; swallowed wholewhole and ADMINISTRATION: not or recommended chewed.

Missed dose be taken as soon asdaily it isremembered.

Ifmeals; forgotten anwhole entire day, missed dose skipped and dose next male fertility with atogepant treatment.

UNDESIRABLE EFFECTS: Common (≥ 1/100 to 1/10): Decreased appetite, taken orally with or without swallowed not split, orbe chewed. human data the effect of atogepant on fertility areEFFECTS: available.

Animal studies showed no<impact on female and o be to taken as soon as once it isremembered.

If forgotten for anfor entire day, and missed dosecrushed to be to skipped andMissed next male fertility withon atogepant treatment.

UNDESIRABLE Common (≥ 1/100 to < 1/10): Decreased appetite, dose taken scheduled.

Dose The recommended dosage of atogepant with concomitant of male nausea, constipation, fatigue/somnolence, decreased.

Refer Section 4.8 the SmPC for details of to scheduled. beas taken asDose soonModification: as it Modification: isremembered.

If forgotten for an entire day, missed dose to be skipped next fertility with fatigue/somnolence, atogepant treatment. UNDESIRABLE EFFECTS: Common (≥to1/100 to of < 1/10): Decreased appetite, nausea, constipation, weightweight decreased.

Refer to Section 4.8 theofSmPC for details of dose taken as The recommended dosage of atogepant with concomitant useand ofuse CYP3A4 inhibitors or strong inhibitors isrecommended 10once mg daily. once daily.

Special Populations: Elderly: Nouse dose other side effects, and for further information. dose taken asor scheduled.

DoseOATP Modification: Themg dosage of atogepant with concomitant of nausea, constipation, fatigue/somnolence, weight decreased. Refer to Section 4.8 of the SmPC for details of other side effects, and for further information. strongstrong CYP3A4 inhibitors strong OATP inhibitors is 10 Special Populations: Elderly: No dose strongneeded.

CYP3A4 or strong OATP inhibitors 10renal mg once daily.

Special Populations: Elderly: No[CLcr] dose other side effects, and for further information. adjustment Renal impairment: In patients withis severe renal impairment (creatinine clearance adjustment needed.

Renalinhibitors impairment: In patients with severe impairment (creatinine clearance [CLcr]  medicinal This medicinal product is subject to additional monitoring.

Thisallow will allow identification of new  This product is subject to additional monitoring.

This will quick quick identification of new adjustment needed.

Renal impairment: In renal patients with (ESRD) severe impairment clearance mL/min), in patients with end-stage disease (CLcr <15 mL/min), the recommended dose 15-29 15-29 mL/min), and inand patients with end-stage renal disease (ESRD) (CLcr renal <15 mL/min), the (creatinine recommended dose [CLcr]  This information. medicinal product is subject to additional monitoring.

Thissuspected will allow quickadverse identification of HPRA new safety Healthcare professionals are asked to report any suspected reactions via HPRA safety information.

Healthcare professionals are asked to report any adverse reactions via 15-29 mL/min), and in patients with end-stage renal disease (ESRD) (CLcr <15 mL/min), the recommended dose is 10 mg once daily.

For patients with ESRD undergoing intermittent dialysis, atogepant should preferably be s 10 mg once daily. For patients with ESRD undergoing intermittent dialysis, atogepant should preferably be Pharmacovigilance; safety information.

Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; website: www.hpra.ie. website: www.hpra.ie. is 10 dialysis. mg onceNo daily.

Foradjustment patients with ESRD undergoing dialysis, atogepant should preferably be Pharmacovigilance; after dose is recommended forintermittent patients with mild or moderate impairment. website: www.hpra.ie. akentaken after dialysis.

No dose adjustment is recommended for patients with mild or moderate renal renal impairment. taken after dialysis.

No dose adjustment is recommended for patients with mild or moderate renal impairment.

LEGAL CATEGORY: POM (S1B).

MARKETING AUTHORISATION NUMBERS: EU/1/23/1750/001 AQUIPTA mg tablets Hepatic impairment: of atogepant in patients with severe hepatic impairment.

No adjustment dose adjustment LEGAL CATEGORY: POM (S1B). MARKETING AUTHORISATION NUMBERS: EU/1/23/1750/001 AQUIPTA 10 mg10 tablets Hepatic impairment: Avoid Avoid use ofuse atogepant in patients with severe hepatic impairment.

No dose LEGAL CATEGORY: POM of (S1B).

MARKETING AUTHORISATION NUMBERS: EU/1/23/1750/001 AQUIPTA 10 mg tablets Hepatic impairment: Avoidwith use mild of atogepant in patients withimpairment. severe hepatic impairment.

No dose adjustment in blisters, in cartons 28 tablets; EU/1/23/1750/003 AQUIPTA 60 mg tablets in blisters, in cartons of 28 tablets. is recommended for patients or moderate hepatic Paediatric Population: The safety in blisters, in cartons of 28 tablets; EU/1/23/1750/003 AQUIPTA 60 mg tablets in blisters, in cartons of 28 tablets. s recommended for patients with mild or moderate hepatic impairment.

Paediatric Population: The safety in blisters, in AUTHORISATION cartons of 28 tablets; EU/1/23/1750/003 AQUIPTA 60 mg tablets inKG, blisters, in cartons of 28Ludwigshafen, tablets. is recommended for in patients with mild or moderate hepatic impairment.

Paediatric Population: The safety MARKETING HOLDER: AbbVie Deutschland GmbH & Co.Knollstrasse, Knollstrasse, 67061, and efficacy of atogepant children (< 18 years of age) not have notbeen yet been established.

CONTRAINDICATIONS: MARKETING AUTHORISATION HOLDER: AbbVie Deutschland GmbH Ludwigshafen, and efficacy of atogepant children (<children 18 years yet established.

CONTRAINDICATIONS: AUTHORISATION HOLDER: AbbVie Deutschland GmbH&&Co. Co.KG, KG, Knollstrasse, 67061, 67061, Ludwigshafen, and efficacy of in atogepant in (<of18age) yearshave of age) have not yet been established.

CONTRAINDICATIONS: MARKETING Germany.

Further information is available on request from: AbbVie Limited, 14 Riverwalk, Citywest Business Hypersensitivity to active substance or any of the excipients.

SPECIAL WARNINGS AND PRECAUTIONS: Serious Germany.

Further information is available on request from: AbbVie Limited, 14 Riverwalk, Citywest Business Hypersensitivity to active substance or any of the excipients.

SPECIAL SPECIAL WARNINGS AND PRECAUTIONS: Serious Further information is available on request from: AbbVie Limited, 14 Riverwalk, Citywest Business Hypersensitivity to active substance or any of the excipients.

WARNINGS AND PRECAUTIONS: Serious Germany.

Campus, 24. OF DATE OF REVISION: November 2024. PI/1750/002. hypersensitivity reactions reported, including anaphylaxis, dyspnoea, rash, pruritus, urticaria and facial oedema.

Campus, DublinDublin 24. DATE REVISION: November 2024. PI/1750/002. hypersensitivity reactions reported, dyspnoea, rash, pruritus, urticaria and facial hypersensitivity reactionsincluding reported,anaphylaxis, including anaphylaxis, dyspnoea, rash, pruritus, urticaria andoedema. facial oedema. Campus, Dublin 24. DATE OF REVISION: November 2024. PI/1750/002.

Most serious reactions have occurred within 24 hours ofuse, first use,use, however, hypersensitivity reactions References: AQUIPTA® Summary Product Characteristics, available at www.medicines.ie.

2. Morena-Ajona D, Most serious reactions have occurred 24 hours however, some some hypersensitivity reactions can can Most serious reactions havewithin occurred withinof 24first hours of first however, some hypersensitivity reactions can References: 1. AQUIPTA® Summary of Product Characteristics, available atatwww.medicines.ie.

2.

Morena-Ajona References: 1.1.AQUIPTA® Summary of of Product Characteristics, available www.medicines.ie.

2. Morena-Ajona D,D, days after Patients should be warned about symptoms ofof hypersensitivity.

IfIfaa reaction etClin al. JMed. J Clin ClinMed. Med.2022;11(6):1656.

2022;11(6):1656.

Ferrari et Nat al.Rev Nat Rev Dis Primers.

2022;8(1):2. occur occur days after Patients should beshould warned symptoms of hypersensitivity.

If a reaction occuradministration. days administration. after administration.

Patients beabout warned about symptoms hypersensitivity. reaction et al. Jet 2022;11(6):1656.

3. Ferrari MD,MD, etMD, al.

Nat Dis Primers.

2022;8(1):2. al.

3. 3.

Ferrari et al.

Rev Dis Primers.

2022;8(1):2. occurs, discontinue atogepant and institute appropriate therapy.

AQUIPTA mgmg tablets 31.5 mg occurs, discontinue atogepant and institute therapy.

AQUIPTA 60 mg60 tablets contain 31.5 mg sodium occurs, discontinue atogepant andappropriate institute appropriate therapy.

AQUIPTA 60 tabletscontain contain 31.5 mgsodium sodium per tablet; this is this equivalent toof 1.6% of the WHO recommended maximum daily intake peristablet; is to equivalent to 1.6% ofrecommended the WHO recommended maximum daily of2 2g gsodium sodium foran anadult. adult. per tablet; this equivalent 1.6% the WHO maximum daily intake ofintake 2 g of sodium for anfor adult.

AQUIPTA 10 mg tablets contain less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumAQUIPTA 10 contain mg tablets thansodium 1 mmol(23 sodium (23 dose, mg) per dose, that to say essentially ‘sodiumAQUIPTA 10 mg tablets lesscontain than 1less mmol mg) per that is to sayis essentially ‘sodiumfree’. Atogepant has orno negligible influence the ability to drive and use machines.

However, ifif affected free’.has Atogepant has or influence negligible influence on the to drive and use machines.

However, affected ree’. Atogepant no or no negligible on theonability toability drive and use machines.

However, if affected IE-AQP-250001 Date preparation: January 2025 by somnolence, patients should exercise caution before driving or or using machinery.

FERTILITY, PREGNANCY IE-AQP-250001 | |Date ofofpreparation: January 2025 by somnolence, patients should exercise caution before driving using machinery.

FERTILITY, PREGNANCY IE-AQP-250001 | Date of preparation: January 2025 by somnolence, patients should exercise caution before driving or using machinery.

FERTILITY, PREGNANCY

THE MEDICAL INDEPENDENT | 3 JUNE 2025

32

Conference Coverage Irish Neurological Association, Annual Meeting, The Rose Hotel, Tralee, Co Kerry, 15-16 May 2025



Continued from p30

The study included the introduction of a SPARK-funded pilot seizure pathway that commenced in Tallaght University Hospital, Dublin, in the last quarter of 2024 with the aim of avoiding admission of appropriate patients presenting with seizures.

Retrospective data was collected for six months before the pilot was introduced and showed that 512 patients were admitted with an initial diagnosis of seizure. Pro-

spective data will be analysed in the future to determine the impact of the pilot.

The authors found that many patients are admitted for possible seizures, often in cases where they require access to timely investigations.

The Mark Gibson Prize for best movement disorder-related presentation was given for a study titled ‘Continuous subcutaneous infusion of foslevodopa/foscarbidopa for people with advanced Parkinson’s disease (PD): A real-world single-centre experience’. Dr Manisha Coran shared findings from the study at the meeting.

The work investigated the impact of continuous subcu-

doctor cpd

taneous infusion of foslevodopa/foscarbidopa in improving gait parameters in patients with advanced PD. The small study of 17 patients found that foslevodopa/ foscarbidopa “is expected to positively impact gait stability, through consistent dopaminergic stimulation and reducing dyskinesia/bradykinesia”.

The study ‘How has the WHO CNS tumour classification of 2021 impacted neuropathology glioma practice?’ received the Hugh Staunton Prize for best presentation by an intern or medical student.

Dr Ciara O’Donoghue told attendees how the authors, based at the National Neuroscience Centre, Beaumont Hospital, Dublin, and Trinity College Dublin, examined whether molecular testing investigations had improved glioma diagnosis and patient care or simply increased diagnostic complexity.

Dr O’Donoghue noted how the World Health Organisation in 2021 had introduced significant changes in the role of molecular diagnostics in investigating tumours.

A retrospective database was compiled spanning the years 2018-2024 and 2,063 gliomas diagnosed in the Beaumont Hospital neuropathology department were identified.

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A proactive approach is required to improve these knowledge gaps and overall care for female patients in neurology

“Of the 361 diffuse gliomas histologically diagnosed in 2024, 10 tumours were reclassified to an alternative histologic type and four tumours were regraded following integration of the molecular findings into a final diagnosis,” the study found.

The authors concluded that: “The risks of overreliance on molecular testing and lack of availability of molecular testing in several centres indicate that high-quality histologic diagnosis will be required for the foreseeable future.”

The neurosurgical prize was won for a study titled ‘A series of unfortunate and uncommon events: Discussing unusual bithalamic infarction with artery of percheron secondary to traumatic vertebral dissection following a cycling accident’.

The winning study, which was presented by Dr Yuval Belisha, looked at the care of a 44-year-old cyclist who suffered injuries after colliding with a vehicle. What was initially an isolated trauma event led to multiple complicated events for the patient, Dr Belisha said.

This led the authors to conclude that “understanding the mechanics of the healthcare system is vital”, while emphasising that the importance of multi-disciplinary team care cannot be overstated.

Finally, the Harold Millar Prize for best overall presentation at the meeting went to a team of doctors at St Vincent’s University Hospital, Dublin, for their work titled ‘Disease-modifying therapies and disease activity in pregnant women with multiple sclerosis’.

In her presentation, Dr Grainne Mulkerrin explained that the study examined the management of pregnant women with multiple sclerosis (MS) between January 2018 and July 2024, during which time 52 pregnancies occurred.

The authors concluded that the evolving management of MS “before and during pregnancy appears to confer better outcomes postpartum”.

A combination of three effective Parkinson’s therapies

in one convenient gel formulation for intestinal infusion1 Carbidopa monohydrate

Levodopa (20 mg/ml)

Increased levodopa bioavailability with LECIGON®

(5 mg/ml)

Entacapone (20 mg/ml)

S t a n d a r d LC I G *

... a reduced levodopa dose can be given

The same effective and stable plasma levodopa levels are achieved

*Levodopa-Carbidopa Intestinal Gel 1. Lecigon Summary of Product Characteristics, 2021.

ABBREVIATED PRESCRIBING INFORMATION. Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinal gel. 1 ml contains 20 mg levodopa, 5 mg carbidopa monohydrate and 20 mg entacapone. Presentation: Yellow or yellowish-red opaque viscous gel. Indications: Treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results. Dosage and administration: Adults/Elderly: Administration by a portable infusion pump directly into the duodenum or upper jejunum via a percutaneous endoscopic gastrostomy(PEG) tube or radiological gastrojejunostony tube. Please consult Summary of Product Characteristics (SmPC) for further information. Only pump Crono LECIG (CE 0476) may be used for the administration of Lecigon. The dose should be titrated to achieve the optimal clinical response in the individual patient, which involves maximising the functional ON-time during the day by minimising the number and duration of OFF episodes (bradykinesia) and minimising ON-time with disabling dyskinesia. Total dose/day of Lecigon is composed of three individually adjusted doses: the morning bolus dose, the continuous maintenance dose, and extra bolus doses. Treatment is usually limited to the patient’s awake period. If medically justified, Lecigon can be administered up to 24 hours/day. The maximum recommended daily dose is 100 ml (2000 mg levodopa, 500 mg carbidopa monohydrate and 2000 mg entacapone. Please consult SmPC for further information. Total morning dose is usually 5–10 ml (100–200 mg levodopa) but not exceeding 15 ml (300 mg levodopa). Continuous maintenance dose is usually 0.7–5.0 ml/hour (15–100 mg levodopa/hour). Extra bolus doses are given if the patient becomes hypokinetic and are normally less than 3ml. An increase in the continuous maintenance dose should be considered if the need for extra doses exceeds 5 doses per day. Please consult SmPC for further information. After initial titration, the morning dose and maintenance dose are fine-tuned over the course of a few weeks.

Lecigon is initially given as monotherapy. If needed, other anti-Parkinsonian medicinal products can be taken concurrently. If treatment with other anti-Parkinsonian medicinal products is discontinued or changed, it may be necessary to adjust the doses of Lecigon. Sudden deterioration in response with recurring motor fluctuations may indicate that the tube has dislocated to the stomach. This needs confirmation by X-ray and may require repositioning. Please consult SmPC for further information. The cartridge is for single use only and should not be used for more than 24 hours. Children: There is no relevant indication for use in children and adolescents. Contraindications: Hypersensitivity to the active substances or any of the excipients, narrow-angle glaucoma, severe heart failure, severe cardiac arrhythmia, acute stroke, severe hepatic impairment. Non-selective MAO-inhibitors and selective MAO type A inhibitors are contraindicated and should be discontinued at least two weeks prior to initiating therapy with Lecigon. Conditions in which adrenergics are contraindicated. Previous neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis. Suspected undiagnosed skin lesions or a history of melanoma. Please consult SmPC for further information. Warnings and precautions: Not recommended for the treatment of drug-induced extrapyramidal reactions. Caution in ischaemic heart disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or of convulsions, past or current psychosis, chronic wide-angle glaucoma, concomitant administration of antipsychotics with dopamine receptor blocking properties or with medicines which may cause orthostatic hypotension. In patients with a history of myocardial infarction who have residual atrial nodal or ventricular arrhythmias, cardiac function should be monitored with particular care during the period of initial dosage adjustments.

Monitor all patients for mental changes, depression with suicidal tendencies, and other serious mental changes. Neuroleptic malignant like syndrome with secondary rhabdomyolysis may occur on abrupt dose reduction/discontinuation of Lecigon. Patients should be monitored for the development of impulse control disorders and review of treatment is recommended if such symptoms develop. Patients and caregivers are advised to monitor for melanomas on a regular basis when using Lecigon. Dose may need to be adjusted downwards to avoid levodopa-induced dyskinesia. Periodically evaluate hepatic, haematopoietic, cardiovascular and renal function during extended therapy. Lecigon contains hydrazine, a degradation product of carbidopa that can be genotoxic and possibly carcinogenic. Reported complications for levodopa/carbidopa in clinical studies include bezoar, ileus, implant site erosion/ulcer, intestinal haemorrhage, intestinal ischaemia, intestinal obstruction, intestinal perforation, intussusception, pancreatitis, peritonitis, pneumoperitoneum and post-operative wound infection. Sudden or gradual worsening of bradykinesia may indicate an obstruction in the tubing system and should be investigated. Weight loss has been associated with the active substances contained in Lecigon, and caregivers should therefore be aware of weight loss. Monitoring of weight is recommended to avoid severe weight loss. Prolonged or persistent diarrhoea that appears during use of entacapone could be a sign of colitis. In case of prolonged or persistent diarrhoea, treatment with the medicinal product should be discontinued and other appropriate medical treatment and investigation considered. Replacement of Lecigon with either levodopa and a DDC inhibitor without entacapone or other dopaminergic therapy may be necessary and should be done slowly. For patients who experience progressive anorexia, asthenia and weight loss within a relatively short period of time, a general medical evaluation including liver function assessment should be considered. Please consult SmPC for further information. Interactions: Antihypertensives, antidepressants, anticholinergics, dopamine receptor antagonists, benzodiazepines, isoniazide, phenytoin, papaverine, sympathicomimetrics , iron, protein-rich diet, amantadine and dopamine agonists (e.g. piribedil) may increase levodopa-related adverse events. Lecigon dose adjustment may be needed when used with these medicines. Lecigon can be taken with MAO type B inhibitors (e.g. selegiline) although serious orthostatic hypotension may occur and the dose of levodopa may need to be reduced. Lecigon may affect metabolism of medicinal products such as S-warfarin and patients should be monitored during initiation with Lecigon therapy when used with this medicine. Please consult SmPC for further information. Pregnancy and lactation: Lecigon is not recommended during pregnancy or in women of childbearing potential not using contraception unless the benefits for the mother outweigh the possible risks to the foetus. It is unknown whether carbidopa and entacapone or their metabolites are excreted in human milk. Breastfeeding should be avoided during treatment with Lecigon. Driving and operation of machinery: Caution; Lecigon can have a major influence on the ability to drive and use machines. Refrain if somnolence and/or sudden sleep episodes occur.

Undesirable effects: Weight loss, anxiety, depression, insomnia, dyskinesia, Parkinson’s disease /exacerbation of parkinsonism (e.g. bradykinesia), orthostatic hypotension, nausea, constipation, diarrhoea, pain in muscles and tissues, musculoskeletal pain, chromaturia, fall. Complications of the device and surgery: Postoperative wound infection, abdominal pain, excessive granulation tissue, complication of device insertion, incision site erythema, post-procedural discharge, procedural pain, procedural site reaction. Refer to SmPC for other undesirable effects. Adverse events should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Special precautions for storage: Store in a refrigerator 2°C - 8°C. Do not freeze. Store in the original package in order to protect from light. For storage instructions after first opening of the medicinal product, refer to the summary of product characteristics.

Pack size: 7 x 47 ml cartridges. Marketing authorisation holder: LobSor Pharmaceuticals AB, Kålsängsgränd 10 D, SE-753 19 Uppsala, Sweden. Distributed by Clonmel Healthcare Ltd, Clonmel, Co. Tipperary. Marketing authorisation number: PA23144/001/001. Medicinal product subject to medical prescription. A copy of the summary of product characteristics is available upon request or alternatively please go to: www.clonmelhealthcare.ie Last revision date: March 2022. Date of Preparation: October 2022. 2022/ADV/LEC/268H

THE MEDICAL INDEPENDENT | 3 JUNE 2025

34

Conference Gallery Irish Neurological Association, Annual Meeting, The Rose Hotel, Tralee, Co Kerry, 15-16 May 2025

Pictured L-to-R: Dr Helena Moore, Irish Neurological Association President, with Dr Cliona O’Donoghue, who was awarded the Hugh Staunton Medal for best presentation by an intern or student

Dr Mark John Kelly

Dr Helena Moore presenting Dr Farkhanda Qaiser with the award for best poster presentation

Dr Julie Sheehan, who was awarded the John Kirker Prize for best epilepsy-related presentation

Dr Helena Moore presenting Dr Manisha Coran with the Mark Gibson medal for best movement disorder presentation

Dr Tze Hong Yong

Dr Robert McFarlane

Dr Alex Dudley

Say

Yes!

Brabio 20 mg/ml & 40 mg/ml (glatiramer acetate) from Viatris The first and only clinically equivalent1 glatiramer acetate alternative in Ireland for adult patients with relapsing-remitting multiple sclerosis (RRMS).

The Medicines Management Programme recommends Brabio® as the preferred product for glatiramer acetate on the High Tech Arrangement.2

ABBREVIATED PRESCRIBING INFORMATION Brabio (glatiramer acetate) 20 mg/ml & 40 mg/ml solution for injection, pre-filled syringe Please refer to Summary of Product Characteristics (SmPC) before prescribing Indications, Dosage and Administration: Glatiramer acetate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) (see SmPC section 5.1 for important information on the population for which efficacy has been established). Glatiramer acetate is not indicated in primary or secondary progressive MS. The initiation of glatiramer acetate treatment should be supervised by a neurologist or a physician experienced in the treatment of MS. 20 mg/ml: The recommended dosage in adults is 20 mg of glatiramer acetate (one pre-filled syringe), administered as a subcutaneous injection once daily.

40 mg/ml: The recommended dosage in adults is 40 mg of glatiramer acetate (one pre-filled syringe), administered as a subcutaneous injection three times a week with at least 48 hours apart. At the present time, it is not known for how long the patient should be treated. A decision concerning long term treatment should be made on an individual basis by the treating physician. Paediatric population: The safety and efficacy of glatiramer acetate in children and adolescents has not been established. 20 mg/ml: However, limited published data suggest that the safety profile in adolescents from 12 to 18 years of age receiving glatiramer acetate 20 mg subcutaneously every day is similar to that seen in adults. There is not enough information available on the use of glatiramer acetate in children below 12 years of age to make any recommendation for its use. Therefore, glatiramer acetate should not be used in this population. 40 mg/ml: There is not enough information available on the use of glatiramer acetate 40 mg/ml TIW in children and adolescents below 18 years of age to make any recommendation for its use. Therefore, glatiramer acetate 40 mg/ml TIW should not be used in this population. Elderly: Glatiramer acetate has not been specifically studied in the elderly. Renal impairment: Glatiramer acetate has not been specifically studied in patients with renal impairment (see SmPC section 4.4). Method of administration Glatiramer acetate is for subcutaneous use. Patients should be instructed in self-injection techniques and should be supervised by a health-care professional the first time they self-inject and for 30 minutes after. A different site should be chosen for every injection, so this will reduce the chances of any irritation or pain at the site of the injection. Sites for self-injection include the abdomen, arms, hips and thighs. The MyJECT device is available should the patients want to make their injection with an injection device. The MyJECT device is an autoinjector to be used with Brabio pre-filled syringes and it has not been tested with other pre-filled syringes. The MyJECT device should be used as recommended in the information provided by the device manufacturer.

Presentation: Solution for injection.

Contraindications: Glatiramer acetate is contraindicated when there is hypersensitivity to the active substance (glatiramer acetate) or to any of the excipients listed in SmPC section 6.1.

Warnings and precautions: Glatiramer acetate should only be administered subcutaneously. Glatiramer acetate should not be administered by intravenous or intramuscular routes. Glatiramer acetate can cause post-injection reactions as well as anaphylactic reactions (see SmPC section 4.8): Post-injection reactions The treating physician should explain to the patient that a reaction associated with at least one of the following symptoms may occur within minutes of a glatiramer acetate injection: vasodilatation (flushing), chest pain, dyspnoea, palpitations or tachycardia (see SmPC section 4.8). The majority of these symptoms is short-lived and resolves spontaneously without any sequelae. Should a severe adverse event occur, the patient must immediately stop glatiramer acetate treatment and contact his/her physician or any emergency doctor.

Symptomatic treatment may be instituted at the discretion of the physician. There is no evidence to suggest that any particular patient groups are at special risk for these reactions.

Nevertheless, caution should be exercised when administering glatiramer acetate to patients with pre-existing cardiac disorders. These patients should be followed up regularly during treatment. Anaphylactic reactions Anaphylactic reactions may occur shortly following administration of glatiramer acetate, even months up to years after initiation of treatment (see SmPC section 4.8). Cases with fatal outcome have been reported. Some signs and symptoms of anaphylactic reactions may overlap with post-injection reactions. All patients receiving treatment with Brabio and caregivers should be informed about the signs and symptoms specific for anaphylactic reactions and that they should seek immediate emergency medical care in case of experiencing such symptoms (see SmPC section 4.8). If an anaphylactic reaction occurs, treatment with Brabio must be discontinued (see section SmPC 4.3). Glatiramer acetate-reactive antibodies were detected in patients' sera during daily chronic treatment with glatiramer acetate. Maximal levels were attained after an average treatment duration of 3-4 months and, thereafter, declined and stabilised at a level slightly higher than baseline. There is no evidence to suggest that these glatiramer acetate-reactive antibodies are neutralising or that their formation is likely to affect the clinical efficacy of glatiramer acetate. In patients with renal impairment, renal function should be monitored while they are treated with glatiramer acetate. Whilst there is no evidence of glomerular deposition of immune complexes in patients, the possibility cannot be excluded. Rare cases of severe liver injury have been observed (including hepatitis with jaundice, liver failure, and in isolated cases liver transplantation). Liver injury occurred from days to years after initiating treatment with glatiramer acetate. Most instances of severe

liver injury resolved with discontinuation of treatment. In some cases, these reactions have occurred in the presence of excessive alcohol consumption, existing or history of liver injury and use of other potentially hepatotoxic medication. Patients should be regularly monitored for signs of hepatic injury and instructed to seek immediate medical attention in case of symptoms of liver injury. In case of clinically significant liver injury, discontinuation of glatiramer acetate should be considered.

Interactions with other medicinal products and other forms of interactions: Interaction between glatiramer acetate and other medicinal products have not been formally evaluated. 20 mg/ml: Observations from existing clinical trials and post-marketing experience do not suggest any significant interactions of glatiramer acetate with therapies commonly used in MS patients, including the concurrent use of corticosteroids for up to 28 days. 40 mg/ml: There are no data on interaction with interferon beta. An increased incidence of injection site reactions has been seen in glatiramer acetate patients receiving concurrent administration of corticosteroids. In vitro work suggests that glatiramer acetate in blood is highly bound to plasma proteins but that it is not displaced by, and does not itself displace, phenytoin or carbamazepine. Nevertheless, as glatiramer acetate has, theoretically, the potential to affect the distribution of protein-bound substances, concomitant use of such medicinal products should be monitored carefully.

Fertility, pregnancy and lactation: Pregnancy A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity. Animal studies do not indicate reproductive toxicity (see SmPC section 5.3). The use of Brabio may be considered during pregnancy, if necessary. Breast feeding The physico-chemical properties and low oral absorption suggest that exposure of newborns/infants to glatiramer acetate via human breast milk is negligible. A non-interventional retrospective study in 60 breastfed infants of mothers exposed to glatiramer acetate compared to 60 breastfed infants of mothers not exposed to any disease modifying therapy and limited post-marketing human data showed no negative effects of glatiramer acetate. Brabio can be used during breast-feeding.

Undesirable effects: Very common (≥ 1/10): Infection, Influenza, Anxiety*, Depression, Headache, Vasodilatation*, Dyspnoea*, Nausea*, Rash*, Arthralgia, Back pain*, Asthenia, Chest pain*, Injection site reactions*§, Pain*. Common (> 1/100, < 1/10): Bronchitis, Gastroenteritis, Herpes simplex, Otitis media, rhinitis, Tooth abscess, Vaginal candidiasis*, Benign neoplasm of skin, Neoplasm, Lymphadenopathy*, Hypersensitivity, Anorexia, Weight increased*, Nervousness, Dysgeusia, Hypertonia, Migraine, Speech disorder, Syncope, Tremor*, Diplopia, Eye disorder*, Ear disorder, Palpitations*, Tachycardia*, Cough, Rhinitis seasonal, Anorectal disorder, Constipation, Dental caries, Dyspepsia, Dysphagia, Faecal incontinence, Vomiting*, Liver function test abnormal, Ecchymosis, Hyperhidrosis, Pruritus, Skin disorder*, Urticaria, Neck pain, Micturition urgency, Pollakiuria, Urinary retention, Chills*, Face oedema*, Injection site atrophy♣, Local reaction*, Oedema peripheral, Oedema, Pyrexia. * More than 2% (> 2/100) higher incidence in the glatiramer acetate treatment group than in the placebo group. Adverse reaction without the * symbol represents a difference of less than or equal to 2%. § The term ‘Injection site reactions’ (various kinds) comprises all adverse events occurring at the injection site excluding injection site atrophy and injection site necrosis, which are presented separately within the table. ♣ Includes terms which relate to localised lipoatrophy at the injection sites. For details of uncommon, rare and very rarely reported adverse events and those of unknown frequency, see SmPC. Reporting of adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie.

Adverse reactions/events should also be reported to the marketing authorisation holder at the email address: pv.ireland@viatris.com or phone 0044(0)8001218267.

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

Marketing Authorisation Number: 20 mg/ml: PA23266/010/001; 40 mg/ml: PA23266/011/001 Marketing Authorisation Holder: Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland.

Full Prescribing Information available on request from: Viatris, Dublin 17. Phone 01 8322250.

Date of revision of Abbreviated Prescribing Information: 02 December 2024 Reference Number: IE-AbPI-Brabio-v009 References: 1. Cohen J, et al. Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis A Randomized Clinical Trial. JAMA Neurol. 2015;72(12):1433-1441.

2. HSE-Medicines Management Programme. Preferred Product: Glatiramer acetate on the High Tech Arrangement. 6 October 2020.

Accessed at https://www.hse.ie/eng/about/who/cspd/medicinesmanagement/evaluation-reports/glatiramer-acetate-preferredproduct.pdf Last accessed 02 Dec 2024.

Job code: IE-GA-2024-00012 DOP: December 2024

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Conference Coverage College of Psychiatrists of Ireland, Spring Conference, Johnstown House Hotel, Co Meath, 10-11 April 2025 ALL REPORTS BY PAT KELLY

Psychiatrists ‘must make their voices heard’

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n his address at this year’s College of Psychiatrists of Ireland (CPsychI) Spring Conference, CPsychI President Dr Lorcan Martin expressed frustration about the failure of policymakers to address the ongoing challenges in psychiatry.

“Our profession still looks over a landscape where challenges and obstacles meet up for an unfortunate [encounter] with bureaucracy,” said Dr Martin. “No one takes up medicine for an easy life, but it can be disheartening when we are faced with the ongoing issues of recruitment and retention, burnout, and presenteeism.”

He criticised the “ever-burgeoning management system with titles we can’t remember”, against a backdrop of

inadequate staffi ng.

He also described the Mental Health Bill 2024 as a “convoluted and unhelpful document” that will make it “almost impossible for psychiatrists to properly do their jobs”.

While proponents of the Bill say it is firmly embedded in human rights, Dr Martin was scathing in his assessment. “‘Human rights’ – the clarion call of those who wish to justify their opinion and signal their virtue,” he told the attendees.

“But do they ever think about the consequences of their view of ‘human rights?’”

Dr Martin referred to the European Convention of Human Rights, specifically the right “not to be subjected to inhuman or degrading treatment or torture”.

“Depriving a psychotic patient of treat-

Mental illness: The autoimmune connection

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he College of Psychiatrists of Ireland Spring Conference featured a talk by Prof Belinda Lennox of the Department of Psychiatry at the University of Oxford, UK. Prof Lennox delivered a presentation titled ‘Autoimmune causes of mental illness and the challenge (and opportunity) for psychiatry’.

In her address, Prof Lennox outlined the growing body of evidence suggesting that a subset of severe mental illnesses may have an autoimmune origin.

She referred to the discovery of neuronal cell surface antibodies that are considered pathogenic in patients with limbic encephalitis, often with prominent psychiatric symptoms, she said. Removal of the antibody results in clinical improvement, and often remission, but the relevance of the same antibodies in patients with purely psychiatric presentations is more controversial.

Screening for antibodies and subsequent treatment is not readily available.

In her talk, Prof Lennox attempted to address these uncertainties, including the challenges and opportunities for psychiatrists and other doctors.

Prof Lennox provided examples of diseases that have an autoimmune basis and told the attendees: “I want to highlight the curious lack of association with rheumatoid arthritis [and mental illness]. If you have schizophrenia, you have half the risk of having rheumatoid arthritis compared to other people. It’s fascinating and we still don’t know why that is.”

She highlighted research that looked at this phenomenon from another angle. “If you have a pre-existing autoimmune condition, you then have an increased risk of developing schizophrenia, and that risk is increased with each infection that you have,” said Prof Lennox. “So, in a stepwise fashion, the more infections you have, the greater your risk of developing schizophrenia.” This risk is increased even more if a patient has a pre-existing autoimmune disorder, she explained.

Prof Lennox gave an overview of a screening study she is conducting with colleagues to identify antibodies in patients and shared research involving plasma exchange as a treatment approach.

“Fifteen years ago, along with a neurologist, I started treating patients with any illness if they had an antibody and had not improved with symptomatic treatment. And we decided we will offer a treatment trial with plasma exchange.

“We described how people got better,” she continued. “I saw young people with profound presentations who were catatonic and couldn’t tolerate antipsychotics… they had plasma exchange and within a week, their illness melted away without other treatments. It melted away and stayed away, so they didn’t have to be transferred back to the psychiatric ward at all.”

Prof Lennox commented: “If you have autoimmune encephalitis and an antibody, and you get treated in less than six weeks, you get a lot better than if that treatment is delayed….

“If there is anything in the patient’s clinical history that makes you suspicious that they have autoimmune encephalitis; if they have had a problem with movements or catatonia; if they have had a recently-diagnosed tumour; if there is a possibility of a paraneoplastic syndrome; if they have had an adverse response to antipsychotics…. If the patient has severe disproportionate cognitive dysfunction, a decreased level of consciousness or new-onset seizures, then you should have this in mind and you should test for antibodies.”

She also warned that there can be a lot of false-negatives in serum antibody blood tests, so clinicians should also be prepared to do more investigations. “And the number one way to do this, unfortunately, is a lumbar puncture,” she said.

“That is the most useful investigation because if there is no inflammation, that is reassuring. But if there is inflammation, we really need to do more.”

ment, or delaying that treatment so that they continue to be tormented by delusions or terrified by persecutory hallucinations, is almost certainly torture,” said Dr Martin.

He added that he wondered if the people who prepared the legislation “ever have known, or have forgotten what it is like, to see a patient profoundly distressed by symptoms that should be alleviated at the earliest opportunity and not delayed by legislation.”

Dr Martin also encouraged attendees to remember the core of their profession.

“We are physicians who tend to the ill with skill and compassion,” he told the conference.

“We are scientists who base our practice on gold-standard outcomes and we are

leaders in our field who can inspire and advocate. What we do require is years of training and professional and personal resilience. We should not and cannot allow that to be buried under rainforests’ worth of paper as we still don’t have proper IT support, or thwarted by management, into which all responsibility and decision-making ability dissolves.

“We are told that restructuring the health service will bring about greater efficiency and a better patient experience,” he continued. “Whether that happens or not remains to be seen, but we must make sure that our voice is heard, especially when it comes to resources and opportunities for training that are on a par with those of our acute hospital colleagues.”

Behavioural disturbances at all stages of life

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he College of Psychiatrists of Ireland Spring Conference featured a number of fascinating parallel sessions that encompassed a variety of ‘hot’ clinical topics.

These included a session on the ‘Management of acute behavioural disturbance across the lifespan: Evidence, guidelines, and best practices’. This session was chaired by Dr Jenny Bond and the talks were delivered by Dr Bond, Dr Sharon Ryan, Dr Sarah O’Dwyer, and Dr Matthew Sadlier.

The presenters explored the management of acute behavioural disturbance across different age groups right through the lifespan, from children and adolescents to adults and the elderly. The speakers discussed age-specific presentations and the development of guidelines, including the recent work on paediatric guidelines at Children’s Health Ireland.

The role of physical restraint was also discussed, as well as rapid tranquilisation in a crisis. The speakers also used case studies to illustrate the challenges in implementing safe and effective interventions, as well as real-world applications.

Dr Bond pointed out the “huge variation in practice” around psychotropic medication between hospitals and different jurisdictions. She also touched on observational studies suggesting that olanzapine is often effective in behavioural disturbances and acute agitation.

She also discussed special considerations, such as using off-label medications, and reviewed more case studies from Children’s Health Ireland.

Dr Ryan discussed current guidelines and the use of rapid tranquilisation and subsequent monitoring for sedation.

“We have tried to give users of this guideline a framework to use to determine when to use rapid tranquilisation,” said Dr Ryan.

“We talk about using it for aggressive or

combative behaviour, [while] also thinking about where that presentation happens and whether there is a need for that patient to remain in hospital.” Other considerations include whether the level of behaviour is causing a risk to themselves or others. “Just as important as knowing when to use it is knowing when not to use it,” said Dr Ryan.

Dr O’Dwyer provided an overview of medications to treat behavioural disturbances, as well as dosing considerations, and the first step is to offer the patient oral medications, she said. Dr O’Dwyer discussed specific medications, and circumstances where ketamine may be appropriate. Among the considerations for doctors in this scenario is respiratory depression, she pointed out.

Dr Sadlier told the conference that the majority of aggressive older adult patients in his clinic suffer with delirium.

“Hyperactive delirium is the one that leads to agitated behaviour,” he pointed out. Dr Sadlier presented data from studies and also discussed the causes of delirium and the brain’s arousal networks.

“What we are essentially trying to do is ease the patient from a hyperactive delirium to a hypoactive delirium,” said Dr Sadlier.

“Medication doesn’t solve delirium in the older adult – what solves delirium is fixing the negative reason for the systemic inflammation that is leading to a breakdown in their neural networks and neural pathway. By giving the medication, you are trying to induce a safer state for the person, which leads them to a lower risk, which leads them to have a period where they can avoid tripping over a chair, or assaulting somebody. The treatment is on that risk basis and overall, the treatment is the removal of the thing that is causing them to have the delirium in the first place.” 

Continued on p38

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Conference Coverage College of Psychiatrists of Ireland, Spring Conference, Johnstown House Hotel, Co Meath, 10-11 April 2025 

Continued from p36

Wide variety of mental health topics discussed at Spring Conference

T

his year’s College of Psychiatrists of Ireland Spring Conference featured a diverse and engaging array of presentations.

Among the topics on the fi rst day was a presentation by Mr John McKeon, CEO and Founder of Kyrie Farm. The inaugural ‘therapeutic farm’ is set to open in Co Kildare in 2026. It is led by mental health specialists and aims to emulate the success of similar initiatives internationally. For example, Hopewell Therapeutic Community and Gould Farm in the US have demonstrated the therapeutic value of farm-based communities in supporting mental health recovery.

Mr McKeon gave the attendees an overview of the history of the project, including a partnership with Maynooth University and consultations with other stakeholders.

In the same session, retired Consultant Adult Psychiatrist Dr Justin Brophy delivered a fascinating presentation titled ‘A motif for navigating the journey of being

Pictured L-to-R: Prof Tom Hutchinson; Dr Aoibhinn Lynch; and Dr Justin Brophy

a psychiatrist’. Using motifs from Carl Jung’s writings and Joseph Campbell’s Th e Hero with a Thousand Faces, Dr Brophy shed light on the possibilities and challenges inherent in a demanding psychiatry career.

Later in the session, chaired by Dr Aoibhinn Lynch, Prof Tom Hutchinson, Director of the McGill Programmes in Whole-Person Care and the Department of Medicine and Department of Oncology at McGill University, Canada, delivered a talk titled ‘Whole-person care: The key to medical practice’.

Prof Hutchinson told the attendees that whole-person care recognises two very different but essential components of patient care – curing and healing.

He said “we have lost touch with our ability to promote healing in our patients”.

In his presentation, Prof Hutchinson used examples from practice to elucidate the difference between ‘curing’ and ‘healing’, and how they can be effectively combined to improve outcomes.

Conference Gallery

Pictured L-to-R: Dr Suzan Elmoula; Dr Thatsinee Jegathesan; and Dr Regina Saku

Dr Andreea Oancă-Gherasim; Dr Victor Oancă; and Dr Deniz Kutay

Dr Louise O’Rourke; Dr Sharon Ryan; and Dr Helen Fitzpatrick

Dr Mohanad Eltieb; Dr Lesley Yau; and Dr Amr Abdoon

THE MEDICAL INDEPENDENT | 3 JUNE 2025

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Life Diary

MI

Photo: istock.com/skynesher

JUNE

41 MINDO QUIZ

Test your knowledge and win €50

42 MOTORING

Shane O’Donoghue on the BMW iX

44 GALLERY

RCPI Institute of Obstetricians and Gynaecologists, Spring Conference

45 GALLERY

RCPI Institute of Medicine, Spring Symposium

THURSDAY 12 – FRIDAY 13 United Kingdom and Ireland Controlled Release Society (UKICRS) Annual Meeting, RCSI, 123 St Stephen’s Green, Dublin 2. The Controlled Release Society was founded in the US in 1978 to advance the science and technology of controlling the release and delivery of active agents. It is recognised worldwide as the premier professional society in this still developing field. The Society has been establishing local ‘chapters’ around the world and the UK chapter was formed in 1994.

In 1998, the UKICRS was formed. The UKICRS addresses a broad range of research fields based on controlled release, which include agriculture, veterinary, food, and cosmetic sciences.

Visit https://www.ukicrs.org MONDAY 16 – THURSDAY 19 International Health Promoting Campuses Conference, University of Limerick. The conference will mark the 10th anniversary since the creation of the Okanagan Charter for Health Promoting Campuses, so the overarching theme is celebration and recognition of 10 years and planning the next steps. The Okanagan Charter has two calls to action: To embed health into all aspects of campus culture across the administration, operations, and academic mandates; and to lead health promotion action and collaboration locally and globally.

Visit https://www.2025ihpc.com SEPTEMBER WEDNESDAY 3 – SUNDAY 7 16th International Conference on Medical Regulation, Dublin. This conference is organised by the International Association of Medical Regulatory Authorities (IAMRA).

Through scientific, educational, and collaborative activities, IAMRA strives to encourage best practices among the world’s medical regulatory authorities and to respond to their current and future needs.

Visit https://www.iamra.com

THURSDAY 4 HSE Integrated Healthcare Conference, Convention Centre, Dublin 1. The Integrated Healthcare Conference returns to the Convention Centre this September. This event will bring together healthcare colleagues, representative groups, service users, and wider health sector stakeholders to explore key themes such as integrated care, healthcare transformation, and building a sustainable and high-functioning healthcare system. The agenda will again feature a combination of plenary and breakout sessions. An international speaker will deliver the conference keynote address. The conference will also feature poster presentations through a call for abstract submissions. Further details to be announced at a later date.

Visit https://healthservice.hse.ie 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 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, which attracts in the region of 350 delegates.

Scientific sessions and a poster exhibition will form an important part of the meeting.

Visit https://www.radiology.ie OCTOBER FRIDAY 10 – SATURDAY 11 Irish Society of Urology, Annual Meeting, Radisson Blu Hotel and Spa, Ballincar, Rosses Point, Co Sligo. More details to follow. For queries or to be included on the mailing list, email: isuevents@rcsi.ie Visit https://www.rcsi.com 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 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

THE MEDICAL INDEPENDENT | 3 JUNE 2025

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Life Mindo Quizzes OUR NEW ADDRESS

Mindo Quizzes Life

Post your answers to: Mindo Quizzes, The Medical Independent, Greencross Publishing Ltd, 1st Floor Ebony House, Main St, Wicklow Town, A67R272. Closing date for entries is 1 July 2025

WIN €50

SPORTS QUIZ 3 June 2025 Q1

Which team won the FA Cup and in doing so won their first ever major trophy?

Q2

Which rugby club won their first European Champions Cup title last month?

Q3

Who won the 2025 Giro d’Italia?

Q4

Name the Irish soccer player who won a Champions League medal with Arsenal recently.

Q5

Name the men’s tennis star who has recently officially retired, having won 22 Grand Slam singles titles in his career.

Q6

Who won the Connacht Senior Football Championship last month, beating Mayo in the final?

CROSSWORD COMPETITION

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For the first time in 15 years, the Leinster Football Final will not feature Dublin. Who will face off in this final? A: Louth v Meath

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Who defeated Cork Constitution to win the All-Ireland League Championship last month? A: Clontarf

Q5

The second tennis Grand Slam event of the year begins later this month. Who is the defending men’s singles champion?

A: Carlos Alcaraz

Q6

Who did the Tennessee Titans select as their number one draft pick in last month’s NFL [National Football League] draft? A: Cam Ward

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Answers to Sports Quiz Competition Solution to Crossword Competition

Liverpool have equalled the record of 20 top flight league titles set

by Manchester United. What year did United win their 20th title?

A: 2013

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A: Zhao Xintong

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The winner of the 6 May 2025 Crossword is Christine Callan, Dublin 15 The winner of the 6 May 2025 Sporting Quiz is Dr Colleen Clinton, Co Galway

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THE MEDICAL INDEPENDENT | 3 JUNE 2025

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Life Motoring SHANE O’DONOGHUE Read more at www.mindo.ie

BMW IX – UPDATED AND BETTER THAN EVER, BUT STILL NOT FOR EVERYONE

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MW first launched the divisive-looking iX back in 2021 as the one and only standalone ‘i’ product, ie, an all-electric model that wasn’t based on an existing range of cars in the Bavarian company’s portfolio. It was tasked with setting the scene for the next generation of BMWs in terms of interior design, technology and, of course, electrification. But all anyone wanted to talk about was its controversial design, which certainly wasn’t to everyone’s liking. Four years later, the market is awash with high-tech electric vehicles, so it’s time for BMW to update the iX to keep it fresh, focusing more on the performance, driving experience, and electric range than anything else.

Exterior design and image If you’re familiar with the original BMW iX and you expected to see a restyle for the new one, then you’re probably looking at the images here and wondering if we used the wrong pictures. Sadly not, as BMW hasn’t dramatically redesigned the car at all. It’s still a large five-door SUV, and it still features an upright “grille” at the front, ultra-slender headlights, and blocky surfacing at the side and rear.

There are some changes that do arguably enhance the appearance, but they’re subtle. The grille finish and

surround have been tweaked and it’s possible to have a sharp thin line of LED light around it that BMW calls the “Iconic Glow”, ensuring everyone knows you’re driving a BMW, even at night. That’s when you’ll spot the redesigned headlights as well, which to these eyes are more successful.

The biggest external change, however, is the addition of a new M Sport option, allowing buyers of lesser models to give them the look of the top-of-the-line M70 derivative. It’s an effective transformation, though the M70 – which is the car featured here – does come with a few unique bits and pieces commensurate with its loftier pricing.

Interior and practicality Whatever your feelings on the exterior design of the BMW iX, the car’s interior has always been universally admired. Somewhat surprisingly, its tactile materials and unusual approach to colours and finishes were never rolled out to the rest of the BMW line-up.

So while there’s a certain homogeneity to most of the firm’s other cars’ interiors, the iX’s is quite different – in a good way.

It gets unique – and really quite appealing – seats, for example, with quilted upholstery, while the door panels are relatively simple yet still manage to feel luxuri-

ous. Though the dashboard features digital instrumentation and a touchscreen behind one smoothly curved surface, it doesn’t dominate the cabin, and the surface underneath extending to the huge windscreen is quite large. All this gives the interior a wonderfully spacious and airy feel, added to by the glass roof and tall side windows.

That sensation continues in the back seats, which are hugely comfortable. All passengers get plenty of headroom and legroom thanks to the completely flat rear floor. About the only demerit in terms of practicality is that the boot – at 500 litres – isn’t as large as you might expect from a car of this size. For example, the BMW X5 SUV, which is a little shorter than the iX, holds up to 650 litres in its boot, depending on specification.

Price and electric range Prices for the revised iX start at €92,585 for the xDrive45 Sport model, undercutting the BMW X5 mentioned above. There’s no ‘basic’ car in the lineup though, as all use two electric motors for all-wheel drive and even the entry-level version produces up to 408hp. Its updated powertrain also means it comes with an impressive official range figure of 603 kilometres.

The new M Sport trim level is available in both xDrive45 and xDrive60 guises, starting at €96,275. The

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Motoring Life

The M70 is competent, but there’s nothing outstandingly different about the way it drives that might curry favour with those who love to drive

xDrive60 model comes with a peak power figure of 544hp, yet an incredible official range of 687 kilometres on a charge. And all cars can make effective use of fast DC chargers, meaning a 10-80 per cent top up in about half an hour at their fastest.

Topping the line-up is the M70, raising the performance with up to 659hp from its motors, though at the expense of outright range. Its official 589-kilometre figure isn’t too shabby, though this model costs considerably more than the others, at €140,465.

BMW driving experience Fans of BMW’s ‘M’ badge may raise an eyebrow at its appearance on the M70 model. Despite the impressive technology and sophistication BMW has poured into the chassis, the iX remains a large, heavy EV. Realistically, how many buyers of such a car truly expect it to handle like a sporty BMW M5?

And so it proves on the road. The M70 is competent, but there’s nothing outstandingly different about the way it drives that might curry favour with those who love to drive. Its quite ridiculous straight-line speed dominates proceedings until you’ve grown used to it, as its 659hp is accompanied by a simply massive 1,015Nm of torque. That means instantaneous acceleration at any time and it goes some way to explaining the sports-carbaiting 3.8-second 0-100km/h time. Your passengers

won’t thank you for demonstrating that to them, as it’s uncomfortably rapid.

One to buy?

As incredible as the performance is from the M70’s powertrain, all versions of the new iX come with more-than-adequate power so, unless you really have to have the top-ranking model, it’s not the one we’d recommend. We’d certainly advocate for choosing the M Sport specification, however, as it gives the iX’s design a much-needed fillip. While the xDrive45’s performance is perfectly strong enough, some will prefer to pay for the reassurance of the xDrive60’s extra range. That’s where the smart money goes.

SPECS FOR BMW IX M70 Motors

All-wheel drive. Electric

Power

659hp during launch control

Torque

1,015Nm

0-100km/h

3.8 seconds

Range

Up to 589km, real world estimate 450km

Battery

108.9kWh usable

Luggage capacity

500 litres, 2.5MT braked towing

Price

Entry from €92,585

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Conference Gallery

Photos: David Coleman – Bobby Studio

RCPI Institute of Obstetricians and Gynaecologists, Spring Conference, No 6, Kildare Street, Dublin, 7 March 2025

Pictured L-to-R: Dr Nikhil Purandare; Prof Sam Coulter-Smith; Dr Suzanne O’Sullivan; Dr Ranee Thakar; and Dr Kristine Steele

Dr Rhona Mahony; Dr Ranee Thakar; Dr Geeta Kumar; Dr Suzanne O’Sullivan; Dr Carmen Regan; and Dr Nadine Farah

Dr Jill Mitchell; Dr Rosie McConnell; Dr Aoife McEvoy; Prof Maeve Eogan; and Dr Cathy Monteith

Dr Sahr Yambasu; Dr Fiona O’Toole; Prof Karen Flood; Dr Farah Nazir; Prof John Higgins; Dr Alex Dakin; and Prof Sam Coulter-Smith

Dr Sarah McDonnell; Dr Ailbhe Duffy; Dr Anne-Marie Dromey and baby Fiona; Dr Jacqui Clifford; and Dr Caoimhe Newell

Dr Francois Gardeil; Dr Mary Holohan; Dr Méabh Ni Bhuinneáin; and Dr Niamh Joyce

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Gallery Life

Photos: David Coleman – Bobby Studio

RCPI Institute of Medicine, Spring Symposium, No 6, Kildare Street, Dublin, 23 January 2025

Pictured L-to-R: Dr Diarmuid O’Shea, President, RCPI; Dr Emer Kelly; Dr Karen Dennehy; and Dr Jeffrey Harte

Mr Diarmuid Breathnach; Prof James O’Neill; Dr Aisling Smith; Dr Nick Power; and Mr Chris McCormack

Dr Diarmuid O’Shea; Prof Ed McKone, Dean, Institute of Medicine, RCPI; Dr Emer Kelly; and Dr Garret Cullen

Dr Peter Lachman; Dr Aisling Smith; Prof Mary Keogan, Dean, Faculty of Pathology, RCPI; and Dr Nick Power

Dr Claire Murray; Dr Eleanor Morris; and Dr Diarmuid O’Shea

Dr Emer Kelly; Dr Maya Hammoud; and Prof Ed McKone

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RXDX Product Focus

Ms Michaela Hagenhofer, General Manager, Commercial Operations, Johnson & Johnson, said: “This report lays bare the reality of the impact Crohn’s disease and colitis can have on a person’s overall quality-of-life and provides a critical insight into the supports needed to improve their wellbeing.

It’s vital that the voices of the community are heard and acted upon to ensure that care and support are tailored to their specific needs. We're committed to supporting CCI and the entire community in this important campaign to improve the lives of people with these conditions in Ireland.”

For more information, visit https://crohnscolitis.ie

CLONMEL HEALTHCARE ANNOUNCES MR DONAGH O'LEARY AS MANAGING DIRECTOR Clonmel Healthcare has announced the appointment of Mr Donagh O'Leary as Managing Director.

Prior to taking up this role, Mr O’Leary served as Director of Marketing and Business Development. He was recently appointed as Vice-Chair of Medicines for Ireland, which represents the manufacturers and suppliers of generic, biosimilar and value added medicines.

In his role, Mr O’Leary is responsible for leading the company’s strategic direction, overMr Donagh O'Leary seeing all aspects of operations, and driving continued growth and innovation. He also focuses on strengthening relationships with key stakeholders, including healthcare professionals, pharmacies, and regulatory bodies.

Bringing over 25 years’ experience in the pharmaceutical and healthcare industries to the role, Mr O’Leary previously held senior positions in Eco Biotechnics Distributors and Mundipharma Pharmaceuticals. He has a proven track record of success in driving commercial growth and managing complex supply chains. He holds a Master’s degree in business from Maynooth University and postgraduate certificate in sustainability leadership in business from Technological University Dublin.

Mr O'Leary said: “Clonmel Healthcare has a strong reputation for providing essential healthcare products to the Irish market, and I'm thrilled to continue collaborating with our exceptional team, building upon this foundation of success.

Our unwavering commitment remains ensuring the right medicine reaches the right patient at the right time, empowering individuals across Ireland to proactively manage their health and wellbeing with dignity and caring for people’s health as a trusted partner."

Clonmel Healthcare is the number one generic supplier of medicines by value and volume in the Irish market. It has a long and proud history of serving the Irish community, offering a wide range of over-the-counter medicines, prescription pharmaceuticals, and innovative speciality medication solutions in areas such as Parkinson’s disease and biosimilars.

For further information, visit: www.clonmelhealthcare.ie

60 PER CENT OF PEOPLE LIVING WITH CROHN’S DISEASE AND COLITIS FACE FINANCIAL DIFFICULTY AS A RESULT OF THEIR CONDITION A new report has shown that 60 per cent of individuals in Ireland living with Crohn’s disease and colitis experience financial difficulties, highlighting the significant financial burden associated with these conditions.

Concerningly, because of costs involved with accessing medical treatment, 47 per cent of people have avoided seeking necessary medical care. The report, Uncovering the Hidden Cost of Crohn’s and Colitis, was launched by Crohn’s and Colitis Ireland (CCI), in partnership with Johnson & Johnson Ireland.

The report provides insight into the challenges faced by people living with Crohn’s disease and colitis and identifies the key areas of improvement in care. The findings revealed that direct medical costs are the most significant financial challenge. People living with these uncurable conditions

Pictured L-to-R: Ms Amy Kelly, Chief Operating Officer, Crohn's & Colitis Ireland; Deputy Ged Nash; Ms Michaela Hagenhofer, General Manager, Commercial Operations, Johnson & Johnson Innovative Medicine; Dr Orlaith Kelly, Consultant Gastroenterologist, Connolly Hospital, Dublin; and Mr Jonathan Healy, who lives with Crohn's disease Photo: Jason Clarke

spend approximately €3,252 annually to manage their disease, which includes treatment and dietary needs. On average, this cohort spends a minimum of 33 hours a year accessing healthcare services, including travelling to and attending appointments.

Indirect costs also significantly impact patients' overall financial stability. ▶ 62 per cent reported that taking time off work due to their condition has negatively affected their financial situation to some or great extent. ▶ 82 per cent of respondents said that they missed work or lost wages as a result of their condition, while 86 per cent reported they have attended work when they have needed to take time off work. ▶ Costs associated with attending medical appointments also play a significant role in the financial burden with 85 per cent citing mileage and travel costs, 83 per cent citing parking fees, 62 per cent citing overnight stays for medical appointments and 49 per cent citing childcare fees.

Ms Amy Kelly, Chief Operations Officer at Crohn’s and Colitis Ireland, said: “We urge the Government to listen to the needs of the community and to improve access to care in Ireland. This includes including Crohn’s disease and colitis in the chronic disease management programme and expanding medical card eligibility, ensuring equitable access to essential medical care. This inclusion would provide free, structured care, potentially reducing patients' out-of-pocket healthcare expenses through fewer emergency room visits, hospital admissions, and lower medication costs.”

While the majority of people living with Crohn’s disease and colitis have qualified for the drugs payment scheme (74 per cent), accessing broader support remains a challenge.

Some 39 per cent expressed difficulty in seeing a GP. Only 29 per cent of people with Crohn’s disease and colitis have a medical card and only 13 per cent have qualified for a GP visit card, frequently denied due to these conditions not automatically meeting the eligibility criteria.

Painting an even more concerning picture is that over a quarter of respondents (26 per cent) reported delaying taking their medication to make it last longer due to the costs involved.

Dr Orlaith Kelly, Consultant Gastroenterologist, Connolly Hospital, Dublin, said: “It's deeply concerning that this report reveals so many people are delaying or skipping essential treatment due to cost, as this negatively impacts how they manage their condition. As a consultant gastroenterologist, I see firsthand the immense challenges people living with Crohn’s disease and colitis face, not only with their health, but also with the financial and emotional burden of managing their condition. This research underscores the urgent need for a more comprehensive approach to care in Ireland, one that ensures financial barriers do not prevent patients from receiving the treatment they desperately need to manage their condition effectively.”

NORDIC PHARMA ANNOUNCES CE MARK APPROVAL FOR LACRIFILL CANALICULAR GEL, PAVING THE WAY FOR EUROPEAN LAUNCH Nordic Group BV, an international pharmaceutical company operating as Nordic Pharma, has announced that Lacrifill, a novel therapy for dry eye, has just received CE mark approval. This significant regulatory milestone, achieved several months ahead of schedule, allows Nordic Pharma to introduce Lacrifill across European markets, with a planned launch in the coming months.

Lacrifill is a cross-linked hyaluronic acid gel designed to temporarily block tear drainage by occluding the canalicular system. By enhancing tear film preservation, Lacrifill helps keep the eyes bathed in their own natural tears, offering an individualised approach to dry eye management. The in-office procedure provides a full fill of the canalicular system and delivers long-lasting effects for up to six months. Dry eye disease is a very prevalent condition affecting up to 30 per cent of the European population. Management of dry eye is particularly challenging in the context of certain ocular surgeries such as cataract and LASIK surgery.

Following the launch of Lacrifill in the US last year, Nordic Pharma now plans to expand its footprint in Europe, bringing this innovative dry eye solution to a broader patient population.

“Receiving CE mark approval for Lacrifill is an important milestone for Nordic Pharma and adds to our commitment to innovative ophthalmic therapies in Europe,” said Ms Charlotte Phelps, CEO of Nordic Group BV. “We are excited to bring this novel dry eye solution to patients and healthcare professionals across Europe and look forward to the upcoming launch.”

With its regulatory approval secured, Nordic Pharma is now preparing for the commercial roll-out of Lacrifill in key European markets. Further details regarding availability and distribution will be shared closer to the launch date.

About Nordic Group BV Nordic Group BV is a privately owned, medium sized international pharmaceutical company focused on the development and commercialisation of specialty products. Its portfolio includes innovative therapies in ophthalmology, rheumatology, and women’s health. With strong roots across Europe, Nordic Group BV now has affiliates in Canada, the US, and Japan and continues to expand globally through strategic acquisitions and partnerships.

For more information about Nordic Pharma, visit www. nordicpharma.com or contact Nordic Pharma Ireland on 01 468 8998 or by email at info@nordicpharma.ie

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Classifieds & Recruitment

HOLIDAY HOMES TO LET Holiday homes available for short-term holiday lets in the heart of Wicklow town.

Choice of a three-bed, sleeping six, or a four-bed, sleeping eight.

Golf, beaches, gardens, hill-walking, Ireland’s garden county has it all.

Contact admin@wicklowholidays.ie for rates and availability

GP AVAILABLE Highly experienced GP seeks sessional work in south-east Dublin.

Available immediately.

CV can be provided via email.

Tel: 089 229 4743

HSE South West currently has the following opportunity:

GENERAL PRACTITIONER, GENERAL MEDICAL SERVICES SCHEME Castleisland, Co Kerry (Post held under GMS Contract) SWMDS79506 The GMS Panel has 662 patients, approximately.

The GMS Scheme provides for the provision of medical care at general practitioner level for medical card patients. Full details of the scheme are set out in the contract documentation and in circulars/regulations issued by the Department of Health and Children.

Doctors participating in the scheme do so under a formal contract for ser vice, so they are contractors rather than employees of the Health Ser vice Executive.

Informal enquiries to: Michael Moriarty, Primary Care Services Manager, HSE South West Email: michael.moriarty@hse.ie Phone: 066 7195690 Closing Date: 13/06/2025 at 12 noon Job Specification and Application Form are available from: www.rezoomo.com/job/79506

Free, independent CPD for doctors, nurses, and pharmacists… all under one roof

THE MEDICAL INDEPENDENT IS AVAILABLE IN PRINT AND DIGITAL

Top up your points on www.medilearning.ie

To advertise, email Daiva at daiva@greenx.ie or Gemma at gemma@greenx.ie

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The Dorsal View

If you have anything you would like to share, please email: info@mindo.ie

A round-up of news and oddities from left field by Dr Doug Witherspoon

Let there be light: How neutrophils have an ‘internal clock’ when it comes to boosting immunity

N

ew research has discovered that daylight not only lifts our spirits, but also boosts our immune systems. A team at the University of Auckland in New Zealand has found that neutrophils seem to have a type of ‘body clock’ of their own and daylight hours have a positive impact on their ability to fight off infections.

The good old zebrafish was called upon again for this re-

search, taking advantage of the ability to breed transparent versions of this fish so researchers can get a good visual overview of what’s happening internally. Its genetic makeup is similar to ours, which doesn’t hurt in the lab.

From the results, it would appear that neutrophils have a type of circadian rhythm. The team observed that neutrophils are able to ‘recognise’ when it is daytime and daylight hours enhance their ability to turbo-charge the immune

system and destroy bacteria.

“Given that neutrophils are the first immune cells to be recruited to sites of inflammation, our discovery has very broad implications for therapeutic benefit in many inflammatory diseases,” commented Associate Prof Christopher Hall from the Department of Molecular Medicine and Pathology at the University and lead researcher. “We think this represents an evolutionary response such that during daylight hours, the host is more active so more likely to encounter bacterial infections.”

It was shown in previous research that immune responses in fish models peaked in the morning, which is their most active early phase. The focus is now on finding out exactly how and why this happens.

Prof Hall added: “This finding paves the way for development of drugs that target the circadian clock in neutrophils to boost their ability to fight infections.”

The authors wrote in their paper: “Host protection against bacterial pathogens, including salmonella, Streptococcus pneumoniae, and Chlamydia muridarum, is greatest when infections occur during an animal’s active phase. This has contributed to the view that the circadian system likely boosts antibacterial immunity as animals transition to activity and the risk of infection increases.”

“Here, we show that neutrophils provide a critical component of the circadian-gated host response to infection by demonstrating that they use their circadian clock machinery to transcriptionally amplify bactericidal activity during the active phase.”

The results may have therapeutic implications for patients who are immunocompromised – if they are not bedbound, a little daylight might be beneficial in ways that extend beyond mental wellbeing. But whether this research is good news for Irish people – or others in the Northern Hemisphere – is debatable. It does make the prospect of another winter with shorter, darker days even less appealing.

If you want to take a deep-dive, the research was published recently in Science Immunology.

Another interesting piece of recent research comes from Tufts University in the US and may also have a wide range of applications, including the ability to regularly and easily monitor toxic stress levels.

This team has come up with an ingenious dental floss that is capable of sampling the cortisol in saliva, which can then be quantified to indicate chronic stress levels in the user.

The device utilises polymer casting technology that has the potential to be adapted to a number of applications, such as monitoring diabetes or tracking fertility. It looks like any standard floss, but contains extremely narrow channels in the floss, from which fluid is drawn into the handle, and then channelled into an attached collection device. The actual cortisol recognition is performed using electropolymerised molecularly imprinted polymers (eMIPs) technology, and is another example of how medicine and engineering can lead to better patient care.

“We didn’t want measurement to create an additional source of stress, so we thought, can we make a sensing device that becomes part of your day-to-day routine? Cortisol is a stress marker found in saliva, so flossing seemed like a natural fit to take a daily sample,” said Prof Sameer Sonkusale, Professor of Electrical and Computer Engineering at Tufts. “The eMIP approach is a game changer.

Biosensors have typically been developed using antibodies or other receptors that pick up the molecule of interest.

Once a marker is found, a lot of work has to go into bioengineering the receiving molecule attached to the sensor. eMIP does not rely on a lot of investment in making antibodies or receptors. If you discover a new marker for stress or any other disease or condition, you can just create a polymer cast in a very short period of time.”

If widely adopted, the system could provide a much more reliable indicator of chronic stress than self-reports and questionnaires.