Irish Pharmacist July 2025

E45 knows how to support skin

E45 cream is used for treating dry skin conditions such as dry/flaky skin, eczema, dry psoriasis, dermatitis and sunburn. Suitable for the whole family. Apply 2-3 times daily for best results*.

Pharmacy insights from the hospital and the community

Welcome to your July issue, where we hope to provide you with some insights into the current state of the profession, with commentary from experienced colleagues.

The days of the pharmacist simply being a medicines dispenser are long gone, and will never return. Pharmacists are ever more influential in healthcare, including in research. To reflect this, our content is tailored to not only reflect the current industry, but also broader areas of healthcare, such as breakthrough research and population health.

In this issue, we also continue our Irish Hospital Pharmacist section to focus on colleagues in the acute hospital setting. Here, we feature an interview with Fergus Nugent, Chief Pharmacist at the Mater Private Hospital Cork, who speaks on a number of topics. These include workforce planning and medicine shortages. Clearly, hospital and community pharmacists have plenty of common issues.

Also in this issue, the IPU elaborates on some of the plans contained in its White Paper, and how these can be achieved.

Positioning pharmacies as "dynamic healthcare hubs" is a tantalising prospect, despite the many details that will need to be ironed-out.

Dr Des Corrigan applies his customary judicial eye to the evidence for the benefits of capsaicin in pain relief. Chilli pepper masochists eventually become desensitised to the painful, burning sensation. This is a result of deactivation of pain receptors, and opens the door to research on how capsaicin may have value as an analgesic.

Terry Maguire also raises important questions about 'skinny pens' becoming perceived as the solution to the obesity epidemic.

We also hope you will take a few clinical nuggets of information away with you with our clinical content written by pharmacists, for pharmacists.

Eamonn Brady and Damien O'Brien sharpen their quills to bring you perspectives on Dental Health, Cholesterol, and the complex and often misunderstood topic of Fatigue.

Enjoy the issue, and feel free to get in touch with whatever is on your mind.

Pat Kelly pat@greenx.ie

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News

04: News

National and international news in pharmacy and healthcare

16: Healthcare hubs

The IPU speaks with Irish Pharmacist about its White Paper and ambitions to revolutionise pharmacy

18: Waxing lyrical

Dealing with ear health in the pharmacy, including the common problem of cerumen impaction

21: Treatment evolution

Pharmacists have had a front-row seat for treatment evolutions in multiple myeloma

24: PSI key activities

The PSI has published details from its Annual Report and Financial Statements for 2024

Hospital Pharmacy

A wide-ranging interview with Fergus Nugent, Chief Pharmacist at the Mater Private Hospital Cork

Comment

32: Fintan Moore

It's important to set prices at a level that respects the associated professional time and input

34: Á i ne Mac Grory

A good leader recognises that the goal is never to be ‘righter’ than the next person

36: Dr Des Corrigan

The case for capsaicin, the pungent chemical from chilli peppers, and how it may have a role to play in pain control

38: Terry Maguire

Is obesity a disease, a syndrome, or a response to an abnormal environment?

In Focus

40: Fatigue

More than just tiredness, fatigue can be complex and comes in many different forms

44: Cholesterol

The health complications that can be caused by high LDL cholesterol, including management and prevention

52: Oral health

An overview of some of the dental and oral health issues that can be dealt with effectively in the community pharmacy

Products

58: Product News

A round-up of product and industry news

Editor Pat Kelly, pat@greenx.ie

Subeditor

Elaine Walsh

elaine@greenx.ie

Creative Director

Laura Kenny

laura@greenx.ie

Administration Manager

Daiva Maciunaite, daiva@greenx.ie

Managing Director

Graham Cooke, graham@greenx.ie

GreenCross Publishing was established in 2007. Publisher and Managing Director: Graham Cooke, graham@greenx.ie

© Copyright GreenCross Publishing Ltd 2025.

Cover design: Laura Kenny. Imagery used: iStock.com

The contents of Irish Pharmacist are protected by copyright. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means – electronic, mechanical or photocopy recording or otherwise –whole or in part, in any form whatsoever for advertising or promotional purposes without the prior written permission of the editor or publishers.

Disclaimer

The views expressed in Irish Pharmacist are not necessarily those of the publishers, editor or editorial advisory board. While the publishers, editor and editorial advisory board have taken every care with regard to accuracy of editorial and advertisement contributions, they cannot be held responsible for any errors or omissions contained.

CETIRIZINE DIHYDROCHLORIDE

Clearing ...to a brighter day

For relief of symptoms of hay fever and other allergic conditions, skin rashes or itchy, watery eyes.

ABBREVIATED PRESCRIBING INFORMATION. Anti-Hist Allergy 10 mg film-coated tablets. Anti-Hist Allergy 1 mg/ml oral solution. dihydrochloride.Presentation: Tablet: White circular biconvex film-coated tablet, embossed ‘A’ on one side and a deep score on the other. seasonal and perennial allergic rhinitis. For the relief of symptoms of chronic idiopathic urticaria. tablet/5 ml oral solution twice daily). Children from 2 to 6 years: with severe renal impairment at less than 10 ml/min creatinine clearance. precaution is recommended if alcohol is taken concomitantly. Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention. Caution in epileptic patients and patients at risk of convulsions is recommended. Pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted. The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation. The use of the oral solution is not recommended in children aged less than 2 years. Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them. The tablet contains lactose. The oral solution contains sorbitol and methyl and propyl parahydroxy benzoate. neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/day). The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased. In sensitive patients, the concurrent use of alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance, although cetirizine does not potentiate the effect of alcohol (0.5 g/L blood levels). Fertility, pregnancy and lactation Therefore, caution should be exercised when prescribing cetirizine to lactating women. Limited data is available on human fertility but no safety concern has been identified. Animal data show no safety concern for human reproduction. operation of machinery: Patients intending to drive, engaging in potentially hazardous activities or operating machinery should not exceed the recommended dose and should take their response to the medicinal product into account. In these sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance. that cetirizine at the recommended dosage has minor adverse effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported. Although cetirizine is a selective antagonist of peripheral H1-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported. Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Mostly this resolves upon discontinuation of the treatment with cetirizine

Legislation to ban disposable vapes 'must be fast-tracked'

Legislation to ban the sale of disposable vapes blamed for an ‘epidemic’ of e-cigarette smoking needs to be fast-tracked, a hearthealth charity has insisted.

Single-use vapes faced a ban in Northern Ireland and the UK on June 1, and the Irish Heart Foundation says there should be no delay in making the measure an all-island one.

Cabinet approved draft laws tabled by then Health Minister Stephen Donnelly in September to ban single-use vapes after Government research concluded they are relatively cheap and disproportionately used by younger people.

Ahead of World No Tobacco Day on May 31, the national stroke and heart charity said that while Ireland led the world on the workplace smoking ban in 2004, we are lagging behind in the battle against youth vaping.

“In light of the forthcoming UK ban, Ireland needs to follow suit — and fast,” said Mark Murphy, Senior Policy Manager. “We need an all-island ban on single-use e-cigarettes, which are detrimental to young people’s health and overturning the strides Ireland has made in reducing nicotine addiction.

“However, even if we successfully introduce a ban on these vapes, we need to future-proof it to avoid loopholes which e-cigarette companies will do everything to exploit.”

Among those loopholes is a move by manufacturers to create super-sized ‘Big-Puff’ vapes offering up to 6,000 puffs compared to the regular 600.

These do not breach existing law as their tanks contain 2ml of vape liquid.

Public sentiment here also supports a crackdown — Ipsos research for the Irish Heart Foundation in 2023 showed that 64 per cent of people back the banning of disposable e-cigarettes in Ireland.

Belgium and France have taken action on disposable vapes, whilst other countries have banned child-friendly

flavours and introduced plain packaging.

“It makes no sense to have a two-tier island where single use vapes are banned in Northern Ireland but freely available in the Republic,” added Mr Murphy.

“Vaping can affect teenage brain development, damage blood vessels, cause high blood pressure, cause changes in heart rhythm

and have serious effects on the respiratory system.

“Worst of all, research indicates that vaping is a gateway to smoking, which is still claiming 12 lives every day in Ireland, making it our biggest cause of preventable death.”

The Irish Heart Foundation is also seeking a dedicated quitline for vaping, tailored to young adults.

Generic Product Launch

Ticagrelor Teva

90 mg Film-coated Tablets

ticagrelor

56 tablet pack

Indications

Ticagrelor Teva co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) or a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event

Ticagrelor Teva Film Coated Tablets Abbreviated Prescribing Information.

Presentation: Each film-coated tablet contains 90mg ticagrelor. Indications: Ticagrelor Teva co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS), or a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event. Dosage and administration: For oral use. Patients taking Ticagrelor Teva should also take a daily low maintenance dose of ASA 75-150mg, unless specifically contraindicated. Adults: ACS: Should be initiated with a single 180mg loading dose (two tablets of 90mg) and then continued at 90mg twice daily. Treatment with Ticagrelor Teva 90mg twice daily is recommended for 12 months in ACS patients unless discontinuation is clinically indicated. Adults: History of MI: 60mg twice daily is the recommended dose when an extended treatment is required for patients with a history of MI of at least one year and a high risk of an atherothrombotic event. Treatment may be started without interruption as continuation therapy after the initial one-year treatment with Ticagrelor Teva 90mg or other adenosine diphosphate (ADP) receptor inhibitor therapy in ACS patients with a high risk of an atherothrombotic event. Treatment can also be initiated up to 2 years from the MI, or within one year after stopping previous ADP receptor inhibitor treatment. Children: Not suitable for use in patients under 18 years of age. Elderly: No dose adjustment is required. Renal impairment: No dose adjustment is necessary. In patients with ACS, it is recommended that renal function is also checked one month after initiating the treatment with ticagrelor, paying special attention to patients ≥75 years, patients with moderate/severe renal impairment and those receiving concomitant treatment with an angiotensin receptor blocker (ARB). Hepatic impairment: No dose adjustment is necessary for patients with mild hepatic impairment. No dose adjustment is not recommended for moderate hepatic impairment, but ticagrelor should be used with caution. Ticagrelor has not been studied in patients with severe hepatic impairment and its use in these patients is contraindicated. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active pathological bleeding. History of intracranial haemorrhage. Severe hepatic impairment. Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor. Precautions and warnings: The use of ticagrelor in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events. Ticagrelor should be used with caution in the following patient groups: Patients with a propensity to bleed (e.g. due to recent trauma, recent surgery, coagulation disorders, active or recent gastrointestinal bleeding) or who are at increased risk of trauma. Patients with concomitant administration of medicinal products that may increase the risk of bleeding (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of ticagrelor dosing. Patients should be advised to inform physicians and dentists that they are taking ticagrelor before any surgery is scheduled and before any new medicinal product is taken. If a patient is to undergo elective surgery and antiplatelet effect is not desired, ticagrelor should be discontinued 5 days prior to surgery. ACS patients with prior ischaemic stroke can be treated with ticagrelor for up to 12 months. Patients with an increased risk of bradycardic events (e.g. patients without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree AV block or bradycardic-related syncope) have been excluded from the main studies evaluating the safety and efficacy of ticagrelor. Therefore, due to the limited clinical experience, ticagrelor should be used with caution in these patients. Caution should be exercised when administering ticagrelor concomitantly with medicinal products known to induce bradycardia. Bradyarrhythmic events and AV blocks have been reported in the post-marketing setting in patients taking ticagrelor, primarily in patients with ACS, where cardiac ischemia and concomitant drugs reducing the heart rate or affecting cardiac conduction are potential confounders. Dyspnoea was reported in patients treated with ticagrelor. Dyspnoea is usually mild to moderate in intensity and often resolves without need for treatment discontinuation. Central sleep apnoea including CheyneStokes respiration has been reported in the post-marketing setting in patients taking ticagrelor. If central sleep apnoea is suspected, further clinical assessment should be considered. Hyperuricaemia may occur during treatment with ticagrelor. Caution is advised in patients with history of hyperuricaemia or gouty arthritis. As a precautionary measure, the use of ticagrelor in patients with uric acid nephropathy is discouraged. Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely with the use of ticagrelor. It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever. TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis. Co-administration of ticagrelor and high maintenance dose ASA (>300mg) is not recommended. Premature discontinuation of treatment should be

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

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

Product subject to prescription which may be renewed (B) Further information is available on request or in the

avoided, as this could result in an increased risk of cardiovascular (CV) death MI or stroke due to the patient’s underlying disease. Interactions: Strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir) are known to reduce the C max and AUC of the active metabolite of ticagrelor, therefore, their concomitant use is contraindicated. Moderate CYP3A4 inhibitors (e.g. amprenavir, aprepitant, erythromycin and fluconazole) can be coadministered with ticagrelor. A 2-fold increase of ticagrelor exposure was observed after daily consumption of large quantities of grapefruit juice. CYP3A inducers (e.g. phenytoin, carbamazepine and phenobarbital) would be expected to decrease the exposure to ticagrelor. Co-administration of ticagrelor with potent CYP3A inducers may decrease exposure and efficacy of ticagrelor, therefore, their concomitant use with ticagrelor is discouraged. Co-administration of cyclosporine with ticagrelor increased ticagrelor Cmax and AUC. No data are available on concomitant use of ticagrelor with other active substances that also are potent P-gp inhibitors and moderate CYP3A4 inhibitors (e.g. verapamil, quinidine) that also may increase ticagrelor exposure. If the association cannot be avoided, their concomitant use should be made with caution. Co-administration of ticagrelor with heparin, enoxaparin and ASA or desmopressin did not have any effect on the pharmacokinetics of ticagrelor or the active metabolite or on ADP-induced platelet aggregation compared with ticagrelor alone. Co-administration of ticagrelor with simvastatin increased simvastatin Cmax and AUC. Ticagrelor may have similar effect on lovastatin, therefore, the concomitant use of ticagrelor with doses of simvastatin or lovastatin greater than 40mg is not recommended. Co-administration of ticagrelor with atorvastatin increased atorvastatin C max and AUC, but these increases are not considered clinically significant. Ticagrelor is a mild CYP3A4 inhibitor. Co-administration of ticagrelor and CYP3A4 substrates with narrow therapeutic indices (i.e. cisapride or ergot alkaloids) is not recommended, as ticagrelor may increase the exposure to these medicinal products. Appropriate clinical and/or laboratory monitoring is recommended when giving narrow therapeutic index P-gp dependent medicinal products like digoxin concomitantly with ticagrelor. Co-administration of ticagrelor with tolbutamide resulted in no change in the plasma levels of either medicinal product, which suggests that ticagrelor is not a CYP2C9 inhibitor and unlikely to alter the CYP2C9 mediated metabolism of medicinal products like warfarin and tolbutamide. Ticagrelor may affect renal excretion of rosuvastatin, increasing the risk for rosuvastatin accumulation. Co-administration of ticagrelor and levonorgestrel and ethinyl oestradiol increased ethinyl oestradiol exposure approximately 20% but did not alter the pharmacokinetics of levonorgestrel. No clinically relevant effect on oral contraceptive efficacy is expected when levonorgestrel and ethinyl oestradiol are co-administered with ticagrelor. Due to observations of mostly asymptomatic ventricular pauses and bradycardia, caution should be exercised when administering ticagrelor concomitantly with medicinal products known to induce bradycardia. Due to reports of cutaneous bleeding abnormalities with SSRIs (e.g. paroxetine, sertraline and citalopram), caution is advised when administering SSRIs with ticagrelor as this may increase the risk of bleeding. Pregnancy and lactation: Patients of childbearing potential should use appropriate contraceptive measures to avoid pregnancy during ticagrelor therapy. Ticagrelor is not recommended during pregnancy. Regarding lactation, a risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ticagrelor therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the patient. Effects on ability to drive and use machines: Ticagrelor has no or negligible influence on the ability to drive and use machines. Dizziness and confusion have been reported with treatment, therefore, patients who experience these symptoms should be cautious while driving or using machines. Adverse reactions: Thrombotic thrombocytopenic purpura, hypersensitivity including angioedema, syncope, and haemorrhage (including intracranial, ear, eye, gastrointestinal, retroperitoneal). Very Common: Blood disorder bleedings, hyperuricaemia, and dyspnoea. Common: Gout/gouty arthritis, dizziness, headache, vertigo, hypotension, respiratory system bleedings, diarrhoea, nausea, dyspepsia, constipation, subcutaneous or dermal bleeding, rash, pruritus, urinary tract bleeding, blood creatinine increased, post procedural haemorrhage, and traumatic bleedings. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: In the event of an overdose, any of the above listed adverse reactions could occur, as well as prolonged duration of bleeding risk associated with platelet inhibition. ECG monitoring should be considered. There is currently no known antidote to reverse the effects of ticagrelor, and ticagrelor is not dialysable. Treatment of overdose should follow local standard medical practice. If bleeding occurs other appropriate supportive measures should be taken. Platelet transfusion is unlikely to be of clinical benefit in patients with bleeding. Legal category: POM. Marketing

Authorisation Number: PA1986/123/001. Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands. Job Code: MED-IE-00092. Date of Preparation: May 2025

New FIP handbook expands pharmacists’ role in managing erectile dysfunction

Managing erectile dysfunction (ED) symptoms and supporting men’s selfcare are the focus of a new handbook published recently by the International Pharmaceutical Federation (FIP). This resource aims to equip pharmacists with the knowledge, tools, and confidence to provide effective, people-centered care within accessible pharmacy settings. ED is the most common male sexual dysfunction, affecting up to half of men over the age of 50, with rising prevalence due to ageing populations and comorbidities such as diabetes and cardiovascular disease. However, stigma and limited access to appropriate care often lead to underdiagnosis and undertreatment. Recognising the pharmacist’s trusted position in communities, the new publication offers practical, evidence-based guidance to address these barriers. The handbook was developed under

FIP’s Practice Transformation Programme on Non-communicable Diseases (NCDs), which supports pharmacists in improving prevention, screening, and management of NCDs. It covers key topics including risk assessment, safe use of phosphodiesterase type 5 inhibitors (PDE5Is), lifestyle changes, counselling, referral pathways, and pharmacists’ professional and ethical responsibilities in ED management.

The growing risks of self-medication, substandard or falsified treatments, and online misinformation further reinforce the importance of pharmacists in safeguarding patients through safe and informed care.

“Pharmacists are often the first healthcare professionals men turn to when they experience symptoms of erectile dysfunction. This handbook empowers pharmacists to go beyond dispensing medicines — to start sensitive conversations, recognise red flags, provide evidence-based guidance, and

New resource for women navigating menopause and diet after cancer

A new innovative resource has been launched for women affected by cancer who are experiencing a treatment-induced menopause. Menopause, Diet & Cancer is designed to offer practical, evidencebased guidance on how dietary and lifestyle choices can alleviate menopausal symptoms and enhance overall wellbeing.

Developed by CORU-registered dietitians Dr Samantha Cushen and Ms Katie Johnston from School of Food and Nutritional Sciences and Cancer Research at University College Cork, in partnership with the Irish Cancer Society, the book emerged from the Women’s Health Initiative ‘Linking You with Support and Advice’ (LYSA) Trial.

Cancer treatments can sometimes trigger a sudden, intense menopause, often

leading to more severe symptoms than those of natural menopause. For some, these symptoms are manageable, while others may find them overwhelming. They can impact quality of life and compound the physical and emotional burdens many women face during and after their cancer journey.

The resource integrates lived experiences, sound scientific evidence, and the invaluable perspectives of patients themselves, making it a trusted companion for women embarking on this complex journey.

Dr Cushen said: “Navigating menopause after cancer is hard enough; finding clear nutrition advice shouldn’t be. For too long, women have been left to piece together guidance from too many,

refer patients when needed, while also identifying underlying health conditions contributing to ED and supporting early detection of serious comorbidities, such as cardiovascular disease and diabetes,” said FIP President Mr Paul Sinclair.

The handbook was developed with contributions from Australia, Canada, GB, India, Ireland, New Zealand and Spain.

“In many parts of the world, access to well-informed physicians with sexual health knowledge is lacking. The ability to provide that care at the local pharmacy is cost-effective. The critical information contained within this handbook should result in improved patient and partner outcomes,” said Dr Gerald Brock, Professor Emeritus of Surgery, Division of Urology, Western University, Canada, pastPresident, International Society for Sexual Medicine and Medical Director, Advanced Medical and Surgical Group.

often conflicting, sources. In a world full of nutrition misinformation, this book brings it all together, offering clarity, compassion, and credible answers in one evidence-based guide designed to support, inform, and reassure.”

The authors stated: “The launch of Menopause, Diet and Cancer marks a crucial breakthrough in Ireland, where dietetic support for cancer survivors is virtually non-existent. This resource takes an important step toward making trusted dietetic advice a standard part of care for women after cancer — but much more needs to be done to ensure every woman has access, and we are determined to make that a reality.”

The resource is available at https:// www.cancer.ie/menopauseplate.

ALLERGIES TAKING OVER YOUR LIFE?

Abbreviated prescribing information

Product Name: Fexo Allergy Relief 120 mg Film-coated tablets

Composition: Each tablet contains 120 mg of fexofenadine hydrochloride equivalent to 112 mg of fexofenadine. Description: Peach coloured oblong, bi-convex film-coated tablet. Dimensions of 14.9-15.3 mm x 6.4-6.8 mm; plain on both sides. Indication(s): Adults and children 12 years and older: Relief of symptoms associated with seasonal allergic rhinitis. Dosage: Adults and children aged 12 years and over: One tablet (120mg) once daily taken before a meal. Children under 12 years: Efficacy and safety of fexofenadine hydrochloride 120 mg has not been studied in children under 12. Children from 6 to 11 years of age: Administer fexofenadine hydrochloride 30 mg. Special populations: No need to adjust the dose confirmed by studies in special risk groups (older people, renally or hepatically impaired patients). Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions for Use: Limited data in the elderly and renally or hepatically impaired patients. Administer with care in these special groups. Warn patients with a history of or ongoing cardiovascular disease that, antihistamines have been associated with the adverse reactions, tachycardia and palpitations. Interactions: Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms. Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use with P-gp inhibitors or inducers can affect the exposure to fexofenadine. Co-administration with P-gp inhibitors erythromycin or ketoconazole resulted in 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly. A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted in a 30 % decrease in AUC of fexofenadine. No interaction with omeprazole. Administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids. Pregnancy and Lactation: Pregnancy: Do not use unless clearly necessary No adequate data from the use of fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Breast-feeding: Not recommended. No data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers’ fexofenadine was found to cross into human breast milk. Fertility: No human data available. Ability to Drive and Use Machinery: Based on the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective tests, Fexo Allergy Relief has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks. Undesirable Effects: Nervous system disorders: Common: headache, drowsiness, dizziness. Gastrointestinal disorders: Common: nausea. General disorders and administration site conditions: Uncommon: fatigue. Refer to the SPC for other undesirable effects. Marketing Authorisation Holder: Rowa Pharmaceuticals Limited., Newtown, Bantry, Co. Cork. Marketing Authorisation Number: PA0074/096/001 Further information and SPC are available from: Rowex Ltd., Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417 E-mail: rowex@rowa-pharma.ie

Legal Category: Not Subject to medical prescription. Date of Preparation: September 2024 CCF FOR API: 26741

Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie) or by emailing Rowex pv@rowa-pharma.ie

Research reveals reduced antimicrobial resistance in E.coli cases

A ground-breaking, large-scale research study from University of Limerick marks a major milestone in the battle against antimicrobial resistance (AMR), a global public health threat that could add a trillion US dollars to worldwide healthcare costs over the next 25 years. Published in Eurosurveillance journal, the research highlights the effectiveness of antimicrobial stewardship and reduced antimicrobial usage practices in the Mid-West that have led to a significant decline in antimicrobial resistance (AMR) in community and hospital settings.

Led by Prof Colum Dunne, Head of the School of Medicine, University of Limerick, the research is a collaborative ‘One Health’ initiative involving UL, HSE Mid-West, the Department of Agriculture, Food and Marine and veterinary professionals.

The analysis of data on Escherichia coli ( E.coli ) isolates, from human and bovine populations in the region from 2012 to 2023, tracks a significant decline in AMR in that timeframe.

E.coli is a bacterial species and is one of the most common pathogens in both humans and bovines. It is also a critical indicator of AMR. Researchers analysed the data from more than 125,000 E.coli isolates from human urine, blood, and bovine samples.

Prof Dunne highlighted the importance of the findings, which underline the success of Ireland’s National Action Plan on Antimicrobial Resistance that emphasises the ‘One Health’ collaborative approach across human, animal, and environmental health sectors.

He said: “Most studies on antimicrobial resistance emphasise the threat to our future health. This is a rare study that describes how some of our efforts in prescribing and use of antimicrobials, especially antibiotics, are already making a difference

and improving levels of potentially problematic resistance. It is encouraging.”

Prof Nuala O’Connell, Consultant Microbiologist, University Hospital Limerick, and Adjunct Clinical Professor at UL’s School of Medicine, said: “Antimicrobial resistance remains a global health threat, and this Irish study shows the importance of having a One Health Approach to stewardship in tackling this problem given the spread of resistant organisms between healthcare facilities, animals as well as food and the environment.”

The data suggest that increased use of ‘preferred’ antimicrobials in humans, along with reduced usage of those ‘to be avoided’, has contributed to the downward trend in resistance. The study’s results underscore the importance of continued surveillance and a One Health approach to monitor

and combat AMR across human, animal, and environmental sectors.

“This study highlights the positive impact that responsible antimicrobial use and stewardship programmes have on combating AMR,” said Prof Dunne.

“It’s clear that a One Health approach, where we integrate human, animal, and environmental health, is essential for addressing this critical global health challenge.”

Dr James Powell, Surveillance Scientist in UL Hospitals and a Principal Investigator for the study, said: “It gives me great pride to see this study reaching completion and publication. It was a big undertaking for us to examine this very large dataset, but the findings are hugely significant, with global implications for the very worrying threat of antimicrobial resistance.”

University of Galway appoints Head of first ever School of Pharmacy and Medical Sciences

University of Galway has announced the appointment of Dr Leo Quinlan as the inaugural Head of the School of Pharmacy and Medical Sciences.

The appointment marks a significant milestone with the creation of the University’s first-ever School of Pharmacy since its foundation in 1845.

Dr Quinlan, a distinguished academic and research leader in the College of Medicine, Nursing and Health Sciences at University of Galway, is currently Vice-Dean for Learning, Teaching and Assessment, and has been a member of the academic community at the University since 1999.

A graduate in Biochemistry with a PhD in stem cell biology, Dr Quinlan has made lasting contributions to education and research, including directing the BSc in Biomedical Science for a decade and serving as the Head of Physiology. Dr Quinlan also played a pivotal role in establishing the University’s new MPharm programme, which will welcome its first cohort of students in September 2025.

The formation of the School of Pharmacy and Medical Sciences is a major strategic development for University of Galway, bringing together pharmacy and the medical sciences in a new academic unit that will shape the future of healthcare education and research in Ireland and beyond.

Dr Leo Quinlan said: “I am honoured to take on this role at such a historic moment for University of Galway. The new School offers a platform to integrate pharmaceutical science into a vibrant, multidisciplinary environment, enabling our students and researchers to make a real and lasting impact on patient care, healthcare systems, and translational research.”

Dr Quinlan also leads the Cellular Physiology Research Lab, a centre of excellence in ion channel, cell and tissue electrophysiology, and serves as a mentor for BioInnovate Ireland, supporting innovation in healthcare technology.

Prof Martin O’Donnell, Dean of the College of Medicine, Nursing and Health Sciences at University of Galway, said: “Dr Quinlan’s appointment represents a

significant step forward for the University. His deep commitment to academic excellence and his leadership in shaping our new pharmacy programme will be instrumental in driving a dynamic, research-led educational environment.

The School of Pharmacy and Medical Sciences is poised to become a centre of excellence, integrating clinical innovation, education, and impactful research that will benefit our students, the region, and healthcare in Ireland.”

Prof John Given, Executive Pharmacy Manager, Galway University Hospitals and Adjunct Professor College of Medicine, Nursing and Health Sciences University of Galway, said: “Dr Quinlan has been instrumental in getting the new Pharmacy programme off the ground at University of Galway. His energy, commitment and organisational skills from day one have been outstanding. To get this programme from the table to the CAO in under two years has been a massive achievement and I wish him well in his new post."

Minister for Health highlights the vital role of community pharmacists at PGEU Conference

At the 2025 PGEU Annual Conference, themed ‘Building a Resilient Pharmacy Workforce for the Future’, Minister for Health Jennifer Carroll MacNeill acknowledged the essential role of community pharmacists as constructive and reliable partners within the healthcare system.

Speaking to an audience of European pharmacy leaders, representatives of national pharmacists’ organisations, chambers, and pharmacy associations, Minister Carroll MacNeill expressed her gratitude for the tireless efforts of pharmacists and their valued partnership in delivering healthcare. She stated: “The future of community pharmacy is bright, with

real and meaningful opportunities for both our health service and pharmacies on many fronts. Governments, particularly the Irish Government, remain committed to supporting community pharmacy services through investment, reform and modernisation.”

The Minister also emphasised her commitment to working collaboratively with pharmacists to unlock new opportunities for the sector: “The report of the Expert Taskforce for Expansion of the Role of Pharmacy in Ireland sets a clear policy direction for future pharmacy care in Ireland and in collaboration with stakeholders, we want a future where Ireland leads the way at a European Level in services available

in community pharmacy. I am keen to work with pharmacists to develop new revenue streams for pharmacies, creating a community pharmacy model that brings care closer to patients.”

Addressing the ongoing workforce challenges facing the sector, PGEU President Clare Fitzell said: "We need to strengthen existing services, broaden the scope of pharmacy practice, and implement effective policy measures to ensure a sustainable workforce capable of meeting growing healthcare demands. This includes efforts to increase the number of pharmacy graduates and to enhance recruitment and retention strategies."

BRIDGING THE GAP IN PAIN RELIEF

DUAL ACTION PAIN RELIEF

References: 1. Daniels et al, Maxigesic® 325 Acute Dental Pain Study. *compared with the same daily dose of standard paracetamol alone. †Faster onset of action than standard Ibuprofen alone. Easolief DUO 500 mg/150 mg film-coated tablets Each tablet contains paracetamol 500 mg and ibuprofen 150 mg. Presentation: White, capsule shaped tablet with breakline on one side and plain on the other side. Indications: Short-term symptomatic treatment of mild to moderate pain. Dosage: Adults/elderly: The usual dosage is one to two tablets taken every six hours up to a maximum of six tablets in 24 hours. Children: Easolief DUO is contraindicated in children under 18 years. Contraindications: Severe heart failure, known hypersensitivity to paracetamol, ibuprofen, other NSAIDs or to any of the excipients, active alcoholism, asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs, history of gastrointestinal bleeding or perforation related to previous NSAID therapy, active or history of recurrent peptic ulceration/haemorrhage, severe hepatic failure or severe renal failure, cerebrovascular or other active bleeding, blood-formation disturbances, during the third trimester of pregnancy. Warnings and precautions: This medicine is for short term use and is not recommended for use beyond 3 days. Clinical studies suggest that use of ibuprofen, particularly at a high dose may be associated with a small increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses should be avoided. Careful consideration should be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events. The use of paracetamol at higher than recommended doses can lead to hepatotoxicity, hepatic failure and death. Patients with impaired liver function or a history of liver disease or who are on long term ibuprofen or paracetamol therapy should have hepatic function monitored at regular intervals. Severe hepatic reactions, including jaundice and cases of fatal hepatitis, though rare, have been reported with ibuprofen. Paracetamol can be used in patients with chronic renal disease without dosage adjustment. There is minimal risk of paracetamol toxicity in patients with moderate to severe renal failure. Caution should be used when initiating treatment with ibuprofen in patients with dehydration. The use of an ACE inhibiting drug, an anti-inflammatory drug and thiazide diuretic at the same time increases the risk of renal impairment. Blood dyscrasias have been rarely reported. Patients on long-term therapy with ibuprofen should have regular haematological monitoring. Like other NSAIDs, ibuprofen can inhibit platelet aggregation. GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered. Use with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided. NSAIDs may lead to onset of new hypertension or worsening of pre-existing hypertension and patients taking antihypertensive medicines with NSAIDs may have an impaired antihypertensive response. Fluid retention and oedema have been observed in some patients taking NSAIDs. NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis and Stevens-Johnson syndrome. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. Products containing ibuprofen should not be administered to patients with acetylsalicylic acid sensitive asthma and should be used with caution in patients with pre-existing asthma. Adverse ophthalmological effects have been observed with NSAIDs. For products containing ibuprofen aseptic meningitis has been reported only rarely. NSAIDs may mask symptoms of infection and fever. In order to avoid exacerbation of disease or adrenal insufficiency, patients who have been on prolonged corticosteroid therapy should have their therapy tapered slowly rather than discontinued abruptly when products containing ibuprofen are added to the treatment program. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA). Interactions: Warfarin, medicines to treat epilepsy, chloramphenicol, probenecid, zidovudine, medicines used to treat tuberculosis such as isoniazid, acetylsalicylic acid, other NSAIDs, medicines to treat high blood pressure or other heart conditions, diuretics, lithium, methotrexate, corticosteroids, flucloxacillin. Fertility, pregnancy and lactation: Easolief DUO is contraindicated during the third trimester of pregnancy. Driving and operation of machinery: Dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected patients should not drive or operate machinery. Undesirable effects: Dizziness, headache, nervousness, tinnitus, oedema, fluid retention, abdominal pain, diarrhoea, dyspepsia, nausea, stomach discomfort, vomiting, flatulence, constipation, slight gastrointestinal blood loss, rash, pruritus, alanine aminotransferase increased, gamma-glutamyltransferase increased, abnormal liver function tests, blood creatinine increased and blood urea increased. Refer to Summary of Product Characteristics for other adverse effects. Adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Pack size: 24 tablets. Marketing authorisation holder: Clonmel Healthcare Ltd. Waterford Road, Clonmel, Co.Tipperary. Marketing authorisation number: PA0126/294/1. Supply through pharmacies only. Date last revised: October 2023. Date prepared: January 2024. 2024/ADV/EAS/004H

Fraudulent websites and adverts using HPRA logo to promote illegal medicines

The Health Products Regulatory Authority (HPRA) recently stated that it has identified a significant increase in recent weeks of online content making false claims whilst promoting medicines, medical devices and cosmetics. It is specifically highlighting a new development where dubious sites and social media posts are using the HPRA logo to falsely claim featured products are endorsed by the HPRA. Other regulatory bodies internationally are being targeted in a similar way.

The unacceptable use of the HPRA logo and name in this way is clearly designed to deceive and mislead consumers. It is urging members of the public not to buy such products online, as they are likely to be from untrustworthy suppliers both engaged in illegal advertising and offering fake or unauthorised products that could pose a health risk. As the independent regulator, the HPRA will never endorse or promote any specific health product or brand, it stressed.

In May alone, the HPRA observed a surge in misleading website activity. The websites, which are hosted outside of Ireland by the e-commerce platform Shopify, are being directly promoted to consumers via fake Facebook profiles and ads. To date, more than 155 Shopify product listings, 124 Facebook profiles and 414 Facebook advertisements have been identified making false claims, with many also fraudulently stating that the product or brand is endorsed by the HPRA.

The HPRA has advised Shopify and Meta of this fraudulent activity and of the public health risks associated with illegal prescription medicines and other unregulated health products sold online. It has requested Shopify and Meta to intercede to proactively identify and remove product listings, fake profiles and adverts from their platforms.

According to Grainne Power, Director of Compliance, HPRA, in recent weeks

there has been an upsurge in fake and misleading online posts. In all cases, despite what is being claimed, these illegal products are manufactured and sourced outside of Ireland.

“We know that a lot of people are being duped into purchasing fake and illegal products via these sites. Working with Revenue’s Customs Service, we have detained a significant number of products at point of entry to the country. A number of these purport to be genuine prescription medicines when in fact the products as presented do not exist as an authorised product in any market.

“One notable example are transdermal delivery microneedle patches which it is claimed contain semaglutide or tirzepatide and, featuring the Irish

flag, are supposedly made in Ireland. In addition to references to the HPRA, there are also claims these products are endorsed nationally by charities, hospitals and individual healthcare professionals. All these claims are untrue. Microneedle patches containing semaglutide, tirzepatide or any GLP1 type medicine are not available as approved medical treatments.

“The key message we are highlighting today is that the HPRA never endorses individual brands nor do we allow our logo to be used in the promotion of health products. Our advice to consumers is that if online sources feature a HPRA logo or suggest a HPRA endorsement, then this is actually a clear sign you are engaging with a dubious site and seller.”

, and

“

Cow’s

“

”

milk allergy is associated with dysbiosis and increased susceptibility for infections

,

and

it has

”

been suggested that it can be managed (in part) by pro-, pre-, and synbiotics

Cow’s milk allergy is associated with dysbiosis and increased susceptibility for infections, and it has been suggested that it can be managed (in part) by pro-, pre-, and synbiotics ”

Pepti Syneo is the only EHF to contain prebiotics probiotics (synbiotics)

CONSTIPATION and abdominal discomfort5^

REDUCED CONSTIPATION and abdominal discomfort5^ SUPERIOR PALATABILITY compared to other EHFs in Ireland6 and the UK CLINICALLY PROVEN to relieve symptoms3 and modulate the gut microbiome4

PALATABILITY compared to other EHFs in Ireland6 and the UK CLINICALLY PROVEN to relieve symptoms3 and modulate the gut microbiome4

DRACMA: Diagnosis and Rationale for Action against Cow's Milk Allergy; EHF: Extensively Hydrolysed Formula; scGOS: Short Chain Galacto-Oligosaccharides; lcFOS: Long Chain Fructo-Oligosaccharides. IMPORTANT NOTICE: Breastfeeding is best. Aptamil Pepti Syneo is a food for special medical purposes for the dietary management of cow's milk allergy. It should only be used under medical supervision, after full consideration of the feeding options available including breastfeeding. Suitable for use as the sole source of nutrition for infants from birth, and/or as part of a balanced diet from 6 months. Refer to label for details. ^Single arm UK study in infants with non-IgE mediated CMA, baseline non-synbiotic formulas vs Aptamil Pepti Syneo, 4 week intervention; ‡ Products can be provided to patients upon request of a healthcare professional. They are intended for the purpose of professional evaluation only.

DRACMA: Diagnosis and Rationale for Action against Cow's Milk Allergy; EHF: Extensively Hydrolysed Formula; scGOS: Short Chain Galacto-Oligosaccharides; lcFOS: Long Chain Fructo-Oligosaccharides. IMPORTANT NOTICE: Breastfeeding is best. Aptamil Pepti Syneo is a food for special medical purposes for the dietary management of cow's milk allergy. It should only be used under medical supervision, after full consideration of the feeding options available including breastfeeding. Suitable for use as the sole source of nutrition for infants from birth, and/or as part of a balanced diet from 6 months. Refer to label for details.

DRACMA: Diagnosis and Rationale for Action against Cow's Milk Allergy; EHF: Extensively Hydrolysed Formula; IMPORTANT NOTICE: Breastfeeding is best. Aptamil Pepti Syneo is a food for special medical purposes for the dietary management of cow's milk allergy. It should only be used under medical supervision, after full consideration of the feeding options available including breastfeeding. Suitable for use as the sole source of nutrition for infants from birth, and/or as part of a balanced diet from 6 months. Refer to label for details. ^Single arm UK study in infants with non-IgE mediated CMA, baseline non-synbiotic formulas vs Aptamil Pepti Syneo, 4 week intervention; ‡ Products can be provided to patients upon request of a healthcare professional. They are intended for the purpose of professional evaluation only.

1. Jensen SA et al. World Allergy Organization Journal. Diagnosis and Rationale for Action against Cow’s Milk Allergy. 2022;15:100668. 2. MIMS Ireland & MIMS UK February 2023. 3. Giampietro PG et al. Pediatr Allergy Immunol 2001;12:83-86. 4. Van der Aa LB et al. Clin Exp Allergy. 2010;(40):795–804 5. Hubbard G et al. Immun Inflamm Dis. 2022;10:e636 6. Data on file, updated independent taste panel report, Campden BRI, October 2020. n=102 HCPs, Campden BRI home usage taste testing. N=102 Dietitians and GPs. Aptamil Pepti 1 & Aptamil Pepti Syneo vs all UK EHFs suitable from birth. Nutricia Ireland, Block 1 Deansgrange Business Park, Deansgrange, Co. Dublin. Date of publication: 03/2024

^Single arm UK study in infants with non-IgE mediated CMA, baseline non-synbiotic formulas vs Aptamil Pepti Syneo, 4 week intervention; ‡ Products can be provided to patients upon request of a healthcare professional. They are intended for the purpose of professional evaluation only.

1. Jensen SA et al. World Allergy Organization Journal. Diagnosis and Rationale for Action against Cow’s Milk Allergy. 2022;15:100668. 2. MIMS Ireland & MIMS UK February 2023. 3. Giampietro PG et al. Pediatr Allergy Immunol 2001;12:83-86. 4. Van der Aa LB et al. Clin Exp Allergy. 2010;(40):795–804 5. Hubbard G et al. Immun Inflamm Dis. 2022;10:e636 6. Data on file, updated independent taste panel report, Campden BRI, October 2020. n=102 HCPs, Campden BRI home usage taste testing. N=102 Dietitians and GPs. Aptamil Pepti 1 & Aptamil Pepti Syneo vs all UK EHFs suitable from birth. Nutricia Ireland, Block 1 Deansgrange Business Park, Deansgrange,

1. Jensen SA et al. World Allergy Organization Journal. Diagnosis and Rationale for Action against Cow’s Milk Allergy. 2022;15:100668. 2. MIMS Ireland & MIMS UK, February 2023. 3. Giampietro PG et al. Pediatr Allergy Immunol 2001;12:83-86. 4. Van der Aa LB et al. Clin Exp Allergy. 2010;(40):795–804 5. Hubbard G et al. Immun Inflamm Dis. 2022;10:e636 6. Data on file, updated independent taste panel report, Campden BRI, October 2020. n=102 HCPs, Campden BRI home usage taste testing. N=102 Dietitians and GPs. Aptamil Pepti 1 & Aptamil Pepti Syneo vs all UK EHFs suitable from birth. Nutricia Ireland, Block 1 Deansgrange Business Park, Deansgrange, Co. Dublin. Date of publication: 03/2024

NEW FROM DRACMA 2022

New research discovery could advance drug treatments for diabetes and obesity

Scientists have unlocked new details on important ‘receptor’ proteins — promising targets for the creation of novel drugs for metabolic conditions ranging from diabetes, to obesity and inflammatory disorders.

The discovery, published recently in Nature and led by Queen’s University Belfast, the University of Glasgow and the University of Pittsburgh, describes ‘atomic level structures’ of an important receptor protein in complex with three different activators, all of which interact and produce their effects in distinct ways.

The researchers believe the new, detailed information on these protein complexes could greatly assist in the discovery of new treatments.

The team studied a receptor, called FFA2, that is normally activated by short-chain fatty acids which are produced when

gut bacteria ferment dietary fibre — compounds that promote positive health outcomes from gut to brain.

Due to its presence in immune cells, the pancreas, fat cells, and hormoneproducing cells that control insulin levels and satiety, FFA2 represents a promising drug target for metabolic disorders, including diabetes and obesity.

The researchers used three different chemical classes of synthetic ‘ligands’ identified by the pharmaceutical industry to activate this receptor and found each to work on FFA2 at different places.

Dr Irina Tikhonova from the School of Pharmacy at Queen’s University Belfast said: "Our molecular dynamics simulations using the Kelvin-2 supercomputer at Queen’s revealed how each compound uniquely changes the receptor's shape, explaining their different signalling

profiles. This computational approach was essential for connecting static structures with dynamic biological function."

Prof Graeme Milligan, Gardiner Chair of Biochemistry at the University of Glasgow’s School of Molecular Biosciences, said: “We are thrilled with our discoveries and believe this work could be extended to be applied across similar receptor proteins that are currently the molecular targets for 35 per cent of clinically used medicines. These principles could have enormous reach and possibility in the world of drug discovery.”

The work demonstrated that each compound makes short-chain fatty acids function more effectively but through different mechanisms, allowing for the possibility of tuning this selectivity to improve pancreatic function, enhance immune cell responses, or control fat storage in adipose tissue.

Scientists solve 30-year micronutrient mystery

An international team of scientists, co-led by researchers at Trinity College Dublin and the University of Florida, has cracked a decades-old mystery in human biology: how our bodies absorb a micronutrient that we rely on for everything from healthy brain function, to guarding against cancer.

Queuosine, a microscopic molecule first discovered in the 1970s, is a vitamin-like micronutrient that we can't make ourselves but can only get from food and our gut bacteria. It’s vital to our health, yet its importance went unnoticed for decades.

Now, in a study published recently in leading international journal Proceedings of the National Academy of Sciences ( PNAS ), researchers have discovered the gene that allows queuosine to enter the cells, a discovery that opens the door for potential therapies to be created to leverage the micronutrient’s role in cancer suppression, memory and how the brain

learns new information.

Scientists have pinpointed the specific gene (SLC35F2) as the first known human transporter of queuosine, which functions as a mysterious ‘transfer RNA’ modification that provides us with the ability to translate genetic code into proteins (the body’s building blocks) correctly.

Prof Vincent Kelly, Professor in Trinity’s School of Biochemistry and Immunology, is senior author of the research article. He said: “We have known for a long time that queuosine influences critical processes like brain health, metabolic regulation, cancer and even responses to stress, but until now we haven’t known how it is salvaged from the gut and distributed to the billions of human cells that take it in.

“For that reason we have been largely hamstrung in our ability to study its role

in health and disease, but this landmark discovery will change that. This study not only paves the way for detailed analysis of potential new therapeutic strategies, but also provides fresh insight into how what we eat — and the microbes we live with — can influence our fundamental biology.”

“For over 30 years, scientists have suspected that there had to be a transporter for this nutrient, but no-one could find it,” said Prof Valérie de CrécyLagard, one of the study’s principal investigators. “We’ve been hunting for it for a long time. This discovery opens up a whole new chapter in understanding how the microbiome and our diet can influence the translation of our genes.

“It’s like a nutrient that fine-tunes how your body reads your genes. The idea that this small compound, which people have barely heard of, plays such an important role, is fascinating.”

KILLS HEAD LICE NATURALLY

Building a community health hub in pharmacies

The Irish Pharmacy Union spoke with Irish Pharmacist about how its White Paper contains a plan to revolutionise community healthcare. Pat Kelly reports

Last year, the Irish Pharmacy Union (IPU) published a White Paper titled Key Enablers for a Sustainable Pharmacy Model: Pharmaceutical Care at the Heart of Healthier Communities In it, the Union provides an overview of the current landscape in community pharmacy in Ireland and key challenges for the sector. The White Paper also offers recommendations for a sustainable future model for community pharmacy, which includes proper resourcing and fostering an environment where pharmacists can utilise their full range of abilities in patient care.

The ultimate objective, says the IPU, is to transform pharmacies into key healthcare hubs in the community, thereby improving access to care and ultimately patient outcomes. The Union also stresses that pharmacies need to be more integrated into our healthcare system and turning them into “dynamic healthcare hubs”.

Practical steps

Irish Pharmacist ( IP ) asked the IPU how this might be achieved. “The White Paper envisions a future where community pharmacies are fully integrated into the Irish healthcare system, transforming them into dynamic healthcare hubs,” said the IPU. “This can be achieved through several practical steps:

1. Digital integration: Streamlining of reimbursement systems to reduce cognitive burden on healthcare professionals. Establishing shared electronic health records (EHRs)

accessible by pharmacists, GPs, and hospitals, and facilitate read and write access that is appropriate to professional function. This ensures seamless communication, improved transitions of care, leading to better continuity of care. It will also facilitate interprofessional collaboration and remove the need for healthcare professionals supporting patients needing to work in the same geographical environment.

2. Policy reform: Develop legislation that empowers pharmacists to practice to their full scope, such as independent prescribing and in the provision of extended primary care services. Pharmacists are medicines experts, and as such are best placed to recommend alternative treatment options when a medicine is in short supply. Facilitating pharmacists to therapeutically substitute supports timely access to medicines and reduces administration for healthcare professionals.

3. Enhanced services: Expand services like health screenings, point of care testing, medication dose adjustment, transitions of care management, expanded vaccination programmes, support for the chronic disease management programmes, and structured medication reviews.

4. Resource allocation: Provide adequate funding and resources to equip pharmacies with the necessary infrastructure and workforce. This would also include that the correct resources across the HSE and Department of Health where in place to enable correct policies to improve pharmaceutical care are in place and implementable plans and cross functional support within the HSE.

“The benefits would include patient accessibility, especially in rural areas, increased efficiency by freeing-up capacity for our GPs and hospital colleagues, and improved health outcomes from early detection through

screenings and preventive care, which can significantly reduce long-term healthcare costs,” the IPU continued.

Admin workload

The White Paper calls for increased “healthcare resilience and capacity building.” IP asked the Union to elaborate on this, and how it can be achieved. Once again, onerous administrative burdens are seen as a barrier to pharmacists working at their full scope of practice. “The IPU’s White Paper emphasises the urgent need to reduce the heavy administrative workload on pharmacists,” the Union commented. “In community pharmacy, 82 per cent of professional service dispensing fees are State-funded and reimbursed. The White Paper seeks to set a vision for interoperability to maximise the potential opportunities for pharmacists to provide care to patients rather than time spent on administrative tasks.”

The IPU also pointed out that it advocates for the implementation of modern ICT systems and streamlined processes to automate routine tasks. “These changes would facilitate pharmacists to dedicate more time to direct patient care, enhancing the overall efficiency and effectiveness of the services they provide,” the spokesperson responded. “By freeingup pharmacists from excessive paperwork, patients would receive more personal attention, create a professional environment to support the future expansion of pharmaceutical care services, ultimately leading to better health outcomes and a more accessible service in community pharmacies.”

The White Paper also proposes a continued expansion of pharmacists’ role in healthcare, and an expansion of prescribing responsibilities. The Expert Taskforce recommended expanding the illnesses that can be prescribed for in the pharmacy, including:

 Allergic rhinitis.

 Cold sores.

 Conjunctivitis.

These changes would facilitate pharmacists to dedicate more time to direct patient care

 Impetigo.

 Oral thrush.

 Shingles (early-stage, mild cases).

 Uncomplicated urinary tract infections.

 Vulvovaginal thrush.

Common conditions

The IPU was also asked about its position on a common clinical conditions service in community pharmacies.

“Many countries have expanded pharmacists’ scope of practice through nationwide pilots and dedicated service programmes, such as prescribing for common clinical conditions, to increase healthcare access,” the IPU told IP. “These clinical services have improved public health when supported by legislative and policy changes, appropriate remuneration models, accredited training and qualifications, and the integration of information technology across care settings.

“The IPU have long highlighted the benefits of a community pharmacy common clinical conditions service and we welcome the development that, in Ireland, the Expert Taskforce on the Expansion of the Role of Pharmacy have recommended that a common conditions service be introduced, with pharmacists provided with prescriptive authority linked to the service and its parameters.”

Concluding, the Union stated: “Pharmacists are at the heart of community healthcare, and the proposed changes outlined in the White Paper represent an opportunity to reimagine their role in line with modern healthcare needs. By addressing systemic challenges and empowering pharmacists, we can create a patientcentered healthcare system that is accessible, efficient, and resilient.” ●

Waxing lyrical about ear health

Eamonn Brady MPSI looks at the problems caused by excess earwax

Earwax, or cerumen, is a naturally occurring substance produced by glands in the ear canal. It serves essential functions such as trapping dust, debris, and microorganisms, preventing infections, and lubricating the ear canal. However, when earwax accumulates excessively, it can lead to a range of issues affecting hearing, comfort, and overall health. This condition is known as cerumen impaction.

Part 1: Who is affected

Excess earwax, or cerumen impaction, is a common condition affecting a significant portion of the population. Studies estimate that approximately 10 per cent of children, 5 per cent of healthy adults, and up to 57 per cent of older adults experience excessive earwax build-up at some point.

Prevalence by age group

 Children: Around 5-10 per cent of children have impacted earwax due to smaller ear canals and increased wax production.

 Adults: About 5 per cent of healthy adults experience cerumen impaction, often due to improper cleaning habits or excessive wax production.

 Elderly (65+ years): The prevalence rises to 35-57 per cent, as ageing leads to drier and harder earwax, making natural removal more difficult.

 Hearing aid users: Between 60-70 per cent of hearing aid wearers develop earwax blockages, as devices can push wax deeper into the ear canal.

Part 2: Reasons for excess earwax

Overproduction of earwax

Some people naturally produce more

earwax than others. Factors such as genetics, age, and hormonal changes can influence earwax production, increasing the likelihood of build-up.

Improper ear cleaning

Using cotton swabs, bobby pins, or other objects to clean the ears often pushes wax deeper into the ear canal rather than removing it. Over time, this leads to impaction, making it harder for the earwax to exit naturally.

Narrow or curved ear canals

People with narrow or uniquely shaped ear canals may have difficulty expelling earwax naturally, causing accumulation. Certain conditions, like exostoses (bony growths in the ear canal), can also block the natural movement of wax.

Ageing and dry earwax

As people age, their earwax tends to become drier and harder, making it more likely to accumulate instead of exiting the ear on its own. This is particularly common in older adults.

Use of hearing aids and earplugs

Hearing aids, earplugs, and earbuds can block earwax from exiting the ear, causing it to build up. These devices may also stimulate the glands to produce more wax.

Environmental factors

Exposure to dusty or polluted environments can lead to increased earwax production as the body works to trap and remove foreign particles.

Part 3: Problems

excess ear wax cause

1. Hearing loss

One of the most common issues caused by excessive earwax is temporary hearing loss. When wax builds up and blocks the ear canal, it prevents sound waves from reaching the eardrum effectively. This can result in:

 Muffled hearing;

 A sensation of fullness in the ear;

 Difficulty understanding speech, especially in noisy environments.

For people who rely on hearing aids, earwax accumulation can further reduce hearing clarity by blocking the microphone or speaker of the device.

2. Ear pain (otalgia)

Excess earwax can cause discomfort and pain, particularly when it hardens or gets impacted against the eardrum. This may lead to:

 A persistent dull ache;

 Pressure in the ear;

 Tenderness or soreness, especially when touching the outer ear.

The pain can be mild or severe, depending on the extent of impaction. In some cases, people may mistake earwax-related pain for an ear infection.

3. Tinnitus (ringing in the ears)

Tinnitus, a condition characterised by ringing, buzzing, or humming sounds in the ears, can be triggered by earwax impaction. This occurs because:

 The blockage affects how sound is transmitted to the auditory nerve.

 Pressure from accumulated wax irritates the eardrum and inner ear structures.

People with tinnitus due to earwax build-up may experience a worsening of symptoms until the blockage is cleared.

4. Dizziness and balance issues

The ear plays a crucial role in balance, and excessive wax build-up can interfere with the vestibular system located in the inner ear. This can result in:

 Dizziness or vertigo (a spinning sensation);

 Unsteadiness or loss of balance;

 Increased risk of falls, particularly in older adults.

Severe cases may lead to nausea and motion sickness-like symptoms.

5. Increased risk of ear infections

Earwax helps prevent infections by trapping harmful bacteria and fungi. However, when too much wax accumulates, it can create an ideal environment for bacterial growth, leading to infections. Symptoms of an ear infection due to excess wax include:

 Pain and swelling;

 Redness around the ear canal;

 Fluid drainage (sometimes foul-smelling);

 Fever in severe cases.

Chronic ear infections can lead to longterm complications such as hearing loss or damage to the ear structures.

6. Coughing and throat irritation

Excess earwax can stimulate the auricular branch of the vagus nerve, which has connections to the throat and respiratory system. As a result, impacted wax may cause:

 Chronic coughing;

 A tickling sensation in the throat;

 A feeling of something being stuck in the throat.

These symptoms can be frustrating, especially if the underlying cause is not immediately recognised.

7. Itching and irritation

Some individuals experience persistent itching in the ear canal due to excess wax. This can be caused by:

 Dry or flaky earwax;

 An allergic reaction to the wax itself;

 Irritation from trapped debris or bacteria.

Scratching or inserting objects into the ear to relieve the itching can worsen the problem by pushing the wax deeper or causing injuries.

8. Ear fullness and pressure

Earwax impaction can create a sensation of fullness or pressure in the ear, similar to what is felt during air travel or sinus congestion. This pressure can be uncomfortable and sometimes mistaken for sinus-related issues or eustachian tube dysfunction.

9. Complications with hearing aids and earphones

People who use hearing aids or earbuds are more prone to earwax build-up, as these devices can:

 Push wax deeper into the canal;

 Block natural wax expulsion;

 Cause irritation, leading to increased wax production.

This can result in reduced device performance, frequent cleaning needs, and discomfort for users.

10. Sleep disturbances

Some people with impacted earwax report difficulties sleeping due to:

 Persistent ear discomfort;

 Tinnitus-related sleep disruption;

 Increased sensitivity to internal noises, such as breathing or heartbeat.

Poor sleep quality can affect overall health, leading to fatigue and difficulty concentrating.

11. Headaches

In rare cases, excessive earwax can

contribute to headaches, especially if it creates significant pressure against the eardrum or inner ear structures. This can lead to tension headaches or exacerbate migraines in susceptible individuals.

12. Psychological impact

Chronic earwax problems can cause frustration, anxiety, and embarrassment, particularly if hearing loss or tinnitus is severe. Some individuals may experience:

 Social withdrawal due to difficulty hearing conversations;

 Anxiety over persistent ear symptoms;

 Decreased quality of life.

Addressing the issue promptly can help alleviate these psychological effects.

Part 4: Safe methods for earwax removal

If excess earwax causes problems, several safe removal methods are available:

1. Over-the-counter ear drops

Earwax-softening drops, containing hydrogen peroxide, mineral oil, or saline, can help loosen wax for easier removal.

2. Irrigation (ear flushing)

 A doctor may use warm water or saline to flush out excess wax.

 At-home irrigation kits are available, but care must be taken to avoid ear infections.

3. Manual removal by a doctor/audiologist or trained specialist

An ear specialist can use specialised tools like curettes or suction devices to safely remove impacted wax.

4. Micro-suction

A professional procedure that uses a small vacuum to remove wax without water, reducing the risk of infections.

5. Avoiding unsafe methods

 Cotton swabs: These often push wax deeper and can cause damage.

 Ear candling: This alternative remedy is ineffective and may lead to burns or

further blockage.

 Sharp objects: Using hairpins or other tools can damage the ear canal or eardrum.

Part 5: When to seek medical attention

You should consult a healthcare provider if you experience:

 Severe ear pain;

 Sudden or significant hearing loss;

 Persistent tinnitus or dizziness;

 Signs of infection (ie, fever, drainage, swelling);

 No improvement after using over-thecounter treatments.

A doctor/audiologist can assess the severity of the impaction and recommend appropriate treatment.

Part 6: What patients can do themselves to prevent excess ear wax

Some of the information below covers what is discussed above but gives further details of what the patients can do themselves to prevent excess earwax.

1. Avoid cotton swabs

Using cotton buds or other objects can push wax deeper into the ear canal, leading to impaction.

2. Use ear drops

Over-the-counter ear drops, containing hydrogen peroxide, saline, or baby oil, can help soften and naturally remove excess wax.

3. Practice good ear hygiene

Clean the outer ear with a damp washcloth regularly but avoid inserting anything inside the ear canal.

4. Stay hydrated

Proper hydration helps maintain the ear’s natural self-cleaning process.

5. Limit earphone use

Frequent use of earbuds can block earwax

from exiting naturally, causing build-up.

6. Try ear irrigation

Occasionally flushing the ear with warm water (using a bulb syringe) can help prevent wax accumulation. However, avoid doing this too often.

7. Use oils

A few drops of olive oil, mineral oil, or coconut oil in the ear once a week can help keep wax soft and prevent excessive build-up.

8. Visit a doctor or other specialist for regular cleaning

If you are prone to earwax build-up, consider professional cleaning by an ENT specialist every few months.

9. Be mindful of skin conditions

Eczema or psoriasis can increase earwax production. Managing these conditions can help prevent build-up.

10. Monitor symptoms

If you experience ear fullness, muffled hearing, etc, get it checked out in case excess ear wax is the issue.

Part 7: Situations where excess earwax becomes an emergency

I discussed some of the symptoms below already, but if they are or become severe as described below, quick medical attention is needed.

1. Sudden and severe hearing loss

If earwax completely blocks the ear canal, it can cause sudden hearing loss. While not life-threatening, it can be alarming and may require urgent removal, especially for individuals who rely on hearing aids or have pre-existing hearing impairments.

2. Extreme dizziness or vertigo

Impacted wax pressing against the eardrum or inner ear can disrupt balance, causing severe dizziness (vertigo). If

vertigo is intense and accompanied by nausea, vomiting, or falls, immediate medical attention is necessary to rule out other serious conditions like Meniere’s disease or inner ear infections.

3. Severe ear pain and infection

Painful earwax impaction can lead to ear infections (otitis externa or media). If an infection develops, symptoms like fever, swelling, fluid discharge (pus), and worsening pain may indicate a need for urgent care. In rare cases, untreated infections can spread to surrounding tissues, leading to serious complications like mastoiditis (infection of the skull bone behind the ear).

4. Persistent coughing or breathing difficulties

Earwax pressing on the vagus nerve can cause chronic coughing or, in rare cases, breathing irregularities. If someone experiences difficulty breathing, medical attention is needed to rule out other causes.

5. Trauma or injury from unsafe removal attempts

Using cotton swabs, sharp objects, or ear candles can push wax deeper, damage the eardrum, or cause bleeding. A perforated eardrum can lead to sudden pain, hearing loss, and dizziness, requiring emergency care. When to seek immediate medical attention if you experience: Sudden or complete hearing loss in one or both ears; Severe ear pain that worsens or spreads; fever and pus-like discharge from the ear; intense dizziness or balance problems leading to falls; headache, swelling, or tenderness behind the ear (possible mastoiditis); bleeding from the ear due to injury. ●

Written by Eamonn Brady (Pharmacist). Whelehans Pharmacies, 38 Pearse St and Clonmore, Mullingar. Tel 04493 34591 (Pearse St) or 04493 10266 (Clonmore). www.whelehans.ie

In partnership with

The evolution of multiple myeloma treatment

Treatment options in multiple myeloma have evolved in recent decades, and pharmacists have had a front-row seat for these advances, working on clinical trials of new therapies and then seeing them enter everyday use in the clinic.

Evelyn Garvey is a hospital pharmacist who began her career in St James’s Hospital, a centre of excellence for haematology, which is where her personal interest in multiple myeloma was cultivated. She moved to the Midlands Regional Hospital in 2005 and has been working there for the past two decades, a period that has seen the field of multiple myeloma treatment undergo huge change.

Garvey recalls her early days working to prepare medications for multiple myeloma patients.

“When I started out, bortezomib was new and it was being used as a part of a doublet — now we know that triplet treatments are more effective and most patients will actually start on a quad,” she notes.

Garvey has a keen interest in clinical research and has participated in many clinical trials involving multiple myeloma patients, both in terms of supportive care and active treatments.

“In multiple myeloma it’s an especially interesting area to work in, because there is such heterogeneity — no two patients are the same,” she says. “Treatments tend to be very individualised for the patient and multiple myeloma can affect multiple areas of the body, so we have to take into account their renal function, their bones, etc.”

As treatment paradigms have evolved, Garvey says she has borne witness to the improvement in patient outcomes that occurred in parallel. “Twenty years ago, I remember patients not having anything

like the outcomes of someone with a similar presentation today,” she says.

These advances are reflected in the data — Irish figures show that the fiveyear net survival for someone diagnosed with MM has increased from 30 per cent in the mid-1990s, to 60 per cent by 2020. Yet a greater number of treatment options has meant greater complexity, with clinicians and pharmacists getting to grips with a plethora of different combinations and balancing the associated toxicities. The hospital pharmacist can recall a number of standout moments over the years.

“The development of bortezomib was a massive one — getting rid of all the alkylators and essentially substituting them with bortezomib has been huge for patients as it’s better tolerated,” she says.

“Lenalidomide would have been a big step forward too, as it was oral and welltolerated, generally speaking.”

In more recent times, the monoclonal antibody daratumumab quickly became a foundational therapy in the treatment of multiple myeloma.

“The efficacy and tolerance are very good with daratumumab,” Garvey points out. “It is an easy add-on to current treatment — typically, if you begin to add in a third drug, you get extra toxicity that becomes unmanageable, but this wasn’t the case with daratumumab. So, we get better outcomes and extra benefits but without that additional toxicity, which is especially important in older patients.”

While originally given intravenously (IV), during the Covid-19 pandemic,

Illustration of microscopic view of bone marrow showing multiple myeloma

the subcutaneous (SC) formulation of daratumumab became available in Ireland — the reduced infusion time meant that multiple myeloma patients who had been advised to cocoon were spending much less time in busy hospitals. Not only did this transform the patient experience, it also led to significant efficiencies on the pharmacist side, Garvey notes.

“When it was IV, there were a large number of vials that had to be drawn up and it was a complex preparation that we would do within the pharmacy,” she explains. “Now that we have moved to subcutaneous, the nurses just draw it up on the ward because it’s faster, so it has reduced our workload. So many patients were on daratumumab and tolerating it so well, that it was taking up more and more of our time — without the introduction of the subcutaneous formulation, we wouldn’t have been able to cope with the sheer volume of work.”

The subcutaneous formulation has also meant that treatment time has been reduced by 97 per cent — while patients previously spent 3.5 hours having an infusion, the typical time for SC administration is less than five minutes. Garvey notes that infusion reactions have also been significantly reduced, from 34 per cent down to 12 per cent.

“It means a much better experience for the patient if they are not having any

adverse reaction but also it’s so quick, they are in and out.” The SC formulation is also not considered a hazardous medicine, so it no longer has to be compounded within the hospital pharmacy. “It could technically be administered anywhere, such as a community satellite unit, primary care centre, or even the patient’s own home.”

The combination of daratumumab, lenalidomide and dexamethasone (DRd) has now become a standard treatment, and Garvey says that the positive results from the MAIA Study, where the combination regimen was seen to reduce the risk of disease progression or death by 44 per cent in newly diagnosed patients who are transplant ineligible, are clearly being replicated in the clinic every day. For pharmacists, fewer support medicines are required compared with the previous combination of Velcade, lenalidomide and dexamethasone (VRd), meaning their workload has been reduced.

Patient support programmes (PSP) have also been a hallmark of the DRd regimen, and Garvey says they have proven invaluable.

“It is proven that they help improve patient adherence and improve patient education because it is ongoing,” she says. “They also improve the reporting of adverse events, meaning there is early management of toxicities so that they can remain on the drug rather than having to stop it because it’s gone too far.”

Another paradigm shift is now on the horizon with the advent of new bispecific therapies such as TECVAYLI® (teclistamab) and TALVEY® (talquetamab), which are new options for patients with relapsed or refractory multiple myeloma. Both agents were made available to Irish patients prior to EMA licence via early access programmes, a move that was hugely welcomed in the multiple myeloma community, Garvey says.

“It was great to be able to access the treatments early, as this group of patients had really failed all other available treatments. We have had several patients who were refractory to all other treatments but because the bispecifics

offer a novel mode of action, they have had a very good response.” Prior to this, their only other option would have been palliative care, she notes, “so this offers a huge advantage”.

In such a dynamic field with emerging therapies, keeping abreast of developments can be a challenge for pharmacists who already have a very busy day job. “As each new drug came along, it was easy for me as the pharmacist to acquire the new information one-by-one but for someone new starting in this area, it is quite difficult to wrap your head around all of this, it is a challenge,” agrees Garvey. She says there are a number of ways in which pharmacists keep themselves educated and get up to speed on the constant advances within the field. Weekly haematology education meetings at the hospital involve someone from the haematology team presenting on a particular topic or case, while pharmaceutical representatives are also welcome to make presentations on medicines that are new to market.

Conferences and educational meetings also form part of their continuing professional development, but Garvey notes that individual pharmacists are well able to educate themselves in their own time, checking websites, journals and even listening to podcasts.

JanssenMedicalCloud is a very useful online resource for up-to-date myeloma treatment information and is one she regularly refers to.

As the field continues to evolve, Garvey is excited to see trial results of therapies involving novel targets such as the antiapoptotic pathway or the bone marrow microenvironments. But overall, she is keen to see more treatments come to clinic that will offer a deeper response. “There is a lot going on in the background and it will be interesting to see the results of all the ongoing clinical trials.”

References available on request

Illustration of microscopic multiple myeloma in a slide

DARZALEX® + Rd results in mPFS 61.9 months vs 34.4 months for Rd alone1*

No new safety concerns were observed1*

*In newly diagnosed transplantineligible multiple myeloma patients. Median follow-up of 64.5 months1

DARZALEX® 20 mg/ml Concentrate for Solution for Infusion and 1,800 mg Solution for Injection PRESCRIBING INFORMATION. ACTIVE INGREDIENT(S): Daratumumab. Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATION(S): Darzalex SC and IV: Newly diagnosed multiple myeloma: in combination with lenalidomide/dexamethasone or bortezomib/melphalan/ prednisone in adults, ineligible for autologous stem cell transplant; in combination with bortezomib, thalidomide and dexamethasone in adults, eligible for autologous stem cell transplant. Relapsed/Refractory multiple myeloma: Monotherapy for adults whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on last therapy. In combination with lenalidomide/dexamethasone or bortezomib/dexamethasone in adults who have received = one prior therapy. Darzalex SC only: in combination with bortezomib/ lenalidomide/dexamethasone in adults with newly diagnosed multiple myeloma; in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy. AL Amyloidosis: Darzalex SC in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. DOSAGE & ADMINISTRATION: Administration by healthcare professional where resuscitation facilities are available, intravenous (IV) infusion or subcutaneous (SC) injection. For SC injection, resuscitation facilities required only for first dose. Adults: Recommended IV dose: 16 mg/kg body weight. Dilute with sodium chloride 0.9% solution for injection and administer by IV infusion using incremental escalation of infusion rate, only if previous infusion well-tolerated. SC dose: inject 15 mL (1,800 mg) Darzalex solution for SC injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes according to dosing schedule. Patients > 120 kg, flatdose 1,800 mg SC, efficacy not established. SC injection: no dose adjustments based on body weight recommended. Darzalex solution for SC injection should never be injected

into areas where the skin is red, bruised, tender, hard or areas where there are scars, rotate injection site. During treatment with Darzalex SC injection, do not administer other medicinal products for subcutaneous use at the same site as Darzalex. Check the vial labels to ensure that the appropriate formulation (IV or SC formulation) and dose is being given as prescribed. For dose and schedule of medicinal products administered with DARZALEX, refer to SmPC 4.2 and the corresponding SmPC for other products. Administer preand post-injection medicinal products to reduce the risk of infusion-related reactions (IRRs). Recommended concomitant medications for management of infusion/injection-related reactions (IRRs): administer pre- IV infusion/ SC Injection medicinal products to all patients 1-3 hours prior to every infusion (corticosteroid, antipyretics and antihistamine). For SC injections, pre-medications can be given orally from the first dose. When dexamethasone is background-regimen specific corticosteroid, this dose will serve as pre-medication on infusion days. If dexamethasone given on infusion day, do not take additional background regimen specific corticosteroids (e.g. prednisone). Post- IV infusion/SC injection medicinal products should be administered to reduce the risk of delayed IRRs: administer oral corticosteroid. SC injections: if the patient experiences no major IRRs after the first three SC injections, post-injection corticosteroids (excluding any background regimen corticosteroids) may be discontinued. Consider short/long acting bronchodilators and inhaled corticosteroids in patients with history of chronic obstructive pulmonary disorder. IV Infusion: Any grade/severity IRRs, interrupt Darzalex immediately and manage symptoms. Re-starting Darzalex IV infusion: reduce infusion rate (refer to SmPC); Grade 4 IRRs (or third occurrence of Grade 3) –permanently discontinue. For haematological toxicity dose delay may be required to allow recovery of blood cell counts. No dose reduction of Darzalex recommended. Consider anti-viral prophylaxis for prevention of herpes zoster virus reactivation. Children: No data available. Elderly/Renal impairment/Hepatic impairment: No dose adjustments. CONTRAINDICATIONS: Hypersensitivity to active substance or excipients. SPECIAL WARNINGS & PRECAUTIONS: Please refer to SmPC for information on the following special warnings and precautions: Traceability; Infusion-related reactions, Neutropenia/Thrombocytopenia, Interference with indirect antiglobulin test (indirect Coombs test), Interference with

determination of complete response, Hepatitis B virus (HBV) reactivation, Body weight (> 120 kg), Excipients. SIDE EFFECTS: Very common: IRRs (Darzalex IV), upper respiratory tract infection, COVID-19, pneumonia, bronchitis, neutropenia, thrombocytopenia, anaemia, lymphopenia, leukopenia, decreased appetite, hypokalaemia, insomnia, peripheral neuropathy, headache, paraesthesia, dizziness, hypertension, cough, dyspnoea, constipation, diarrhoea, nausea, vomiting, abdominal pain, rash, musculoskeletal pain, arthralgia, muscle spasms, oedema peripheral, fatigue, pyrexia, asthenia. Common: IRRs (Darzalex SC), urinary tract infection, sepsis, cytomegalovirus infection, hypogammaglobulinemia, hyperglycaemia, hypocalcaemia, dehydration, syncope, atrial fibrillation, pulmonary oedema, pancreatitis, pruritus, chills. SC only: injection site reactions. Uncommon: Hepatitis B Virus reactivation. Refer to SmPC for further information on side effects. LEGAL CATEGORY: Prescription only medicine (POM). PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S): 5 ml vial (100 mg daratumumab), X 1, EU/1/16/1101/001; 20 ml vial (400 mg daratumumab), X 1, EU/1/16/1101/002; 15 ml vial (1 800 mg daratumumab), X 1, EU/1/16/1101/004. MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER INFORMATION IS AVAILABLE FROM: Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, IRL – Co. Cork P43 FA46. Prescribing information updated: April 2025.

Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse events via: HPRA Pharmacovigilance, Website: www.hpra. ie. Adverse events should also be reported to Janssen Sciences Ireland UC a Johnson & Johnson Company 0044 1494 567447 or at dsafety@its.jnj.com.

mPFS, median progression free survival; Rd, lenalidomide + dexamethasone; SC, subcutaneous.

References: 1. Kumar DJ, et al. Poster presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition. December 10–13, 2022. #4559.

CP-525771 | Date of Preparation: June 2025

Johnson & Johnson Ireland 2025

PSI publishes Annual Report

Regulator outlines its activities and financial statements for 2024

The PSI has published its Annual Report and Financial Statements for 2024, outlining the ways the pharmacy regulator pursued its objectives in regulating pharmacists and pharmacies in Ireland.

The PSI said its key activities during 2024 included:

 Significant contribution to the Department of Health’s Expert Taskforce to support the expansion of the role of pharmacy, resulting in recommendations empowering pharmacists to extend prescriptions and to prescribe within their scope of practice.

 Participation in the Community Pharmacy Expansion Implementation Oversight Group to oversee the delivery of a Common Conditions Service in community pharmacies, a recommendation of the Taskforce report.

 Progressing initiatives to ensure the sustainability of community pharmacy, through implementation of recommendations from the PSI’s Workforce Intelligence Report, including establishing a multi-stakeholder Future Pharmacy Workforce Group with the Department of Health.

 Development of a new PSI Corporate Strategy for 2025-2028.

 Launch of a new PSI website.

 Streamlining the Third Country Qualification Recognition Route (TCQR), the application process for non-EU pharmacists to apply for recognition to practise in Ireland.

 Registering 417 new pharmacists, bringing the total number of pharmacists eligible to practise in Ireland to 7,731 at the end of 2024.

 Maintaining the register of pharmacies, which at the end of the year numbered 1,989, an increase of four on 2023.

 Handling 78 formal complaints, an increase of 6% on the previous year, and improving the PSI’s online facility to make these complaints online.

 Conducting 347 risk-based pharmacy inspections.

Commenting on the publication of the Annual Report, PSI Registrar and Chief Officer Joanne Kissane said: “This annual report marks the progression of a significant body of work that comes at a time of enormous change and development for pharmacy.”

Expert taskforce

“We were pleased to continue our work as part of the Expert Taskforce to support the expansion of the role of pharmacy, established by the Minister for Health in 2023. It has been a long-term objective of the PSI and the Department of Health to expand the role of pharmacy, as part of an integrated healthcare system and to realise the vision as set out in Sláintecare to best meet patient needs within the community. As part of this, the PSI has very actively participated in initiatives which are integral to advancing the recommendations of the Expert Taskforce, bringing about

changes in how care will be available through pharmacies into the future.”

The first recommendation of the Taskforce – empowering pharmacists to extend certain prescriptions – came into legislative effect in March 2024.

The PSI has supported legislative changes, developed resources including principle-based guidelines for pharmacists, and collaborated with the Irish Institute of Pharmacy to develop further training and practice supports for pharmacists. The final report of the Taskforce, published in August 2024, included a recommendation to enable pharmacists to act as independent prescribers within and

relating to their scope of practice and competence, to be implemented in a stepwise manner, beginning with a Common Conditions Service.

Milestone

“The final recommendations of the Taskforce marked another important milestone for pharmacy and its future direction. We were pleased to contribute to the final report, in collaboration with other stakeholders. The establishment of the Community Pharmacy Expansion Implementation Oversight Group to oversee the delivery of a Common Conditions Service in 2025 benefits from a range of clinical, regulatory, academic and policy colleagues’ expertise.  We are pleased

PSI are documented in the annual report, including registration data, work in relation to compliance, and complaint-handling.

There was a continued increase in the Register of Pharmacists in 2024, with a total of 7,731 registered pharmacists at the end of the year. In 2024, there were 417 new pharmacist registrations. Of those newlyregistered pharmacists, 41 per cent received their qualification from Irish universities. Other new registrants to Ireland have qualifications from 31 different countries worldwide. The total number of pharmacies registered was 1,989, an increase of four from the previous year.

The PSI said it conducted 347 risk-

In 2024, there were 417 new pharmacist registrations. Of those newly-registered pharmacists, 41 per cent received their qualification from Irish universities

to support its ongoing work.”

The PSI said it remains focused on ensuring the sustainability of the pharmacy workforce, in collaboration with a range of pharmacy, health service, and policy partners. During 2024, the regulator sought to clarify governance roles and responsibilities in pharmacy with the publication of new guidance.

Further to the Government decision to expand access to new healthcare training places last year, the PSI has been supporting the move to establish three new pharmacy programmes in the State. One of the PSI’s core functions is to evaluate, for accreditation purposes, programmes of education that lead to qualifications appropriate for practice as a pharmacist. There was important engagement with the higher education institutions in preparation for new programme accreditation visits. The core statutory functions of the

based inspections last year, as well as 18 registration-related inspections for new pharmacy openings or changes in pharmacy ownership. Risk-based inspections are undertaken following a review of information available to the regulator, and/or in the event of a member of the public or external body raising a concern. The PSI’s compliance role involves ensuring the safety of pharmacy care and services in accordance with legislative and regulatory requirements.

Complaints

As the body responsible for dealing with statutory complaints about pharmacists and pharmacies, the PSI received 78 complaints in 2024, up from 73 in 2023. The majority of these were made by members of the public. Not all complaints reach the threshold to be dealt with by an inquiry. Twenty hearings were conducted before the PSI’s Committees of Inquiry in 2024.

In addition, the PSI reviewed and took actions to address general concerns raised with it about a range of pharmacy matters. Almost all (92 per cent) of the 111 concerns came from members of the public. These concerns are expressed where someone does not wish to make a formal complaint but provides information to the PSI.

The PSI also made inroads as part of its strategic objective to build its organisational capabilities and enhance its performance as a regulatory body, particularly its digital offering to the public. A new website was launched in the summer of 2024, offering significantly improved functionality and searchability for users. This is an important information platform for the public, including those registered or seeking to register as a pharmacist, or to open a pharmacy, as well as for those interested in pharmacist education or pharmacy resources provided by the PSI. Advancing its ongoing business transformation project, the regulator said it developed a new online facility, where people can submit their complaints, concerns or queries in relation to pharmacists and pharmacies.  President of the PSI, Katherine Morrow, reflected on the achievements and future direction of the PSI: “This annual report is the last under our Corporate Strategy 20212024, and it marks the progression of several significant strategic work programmes in addition to delivering our significant functions as a regulatory body. During the year, the PSI Council also focused on the organisation’s future development and strategy for 2025-2028. This considers the evolving pharmacy and healthcare landscape and benefitted from broad public consultation.

“The PSI looks forward to continuing its remit to ensure continued trust in pharmacy through effective regulation, achieved successfully in collaboration with patients, and wider public, all those registered with PSI, and our many other stakeholders.” ●

From community to hospital IRISH HOSPITAL

PHARMACIST

NEWS AND OPINION FROM THE IRISH HOSPITAL PHARMACY SECTOR

Fergus

Nugent, Chief Pharmacist at the Mater Private Hospital Cork, speaks to Niamh Cahill about his education, career, and the future of Irish hospital pharmacy

As a self-proclaimed ‘chemistry nerd’, it was perhaps no accident that Fergus Nugent chose to pursue a career in pharmacy. Coming from a family with two GPs (father and sister) and a physiotherapist (sister), you could say that medicine was in the genes.

“I was quite a chemistry nerd as a kid. Physics, chemistry, and maths were really my strong suits,” he recalled. “Unfortunately, my Gaeilge and English were not my strong points. I wasn’t going to get the points here and pharmacy places were limited in Ireland in 1995, so I went through the UK system. I headed over and did my degree at the University of Brighton.”

The move was a fortunate one, as it provided the Tipperary native with a great breadth of pharmacy experience and education. The pharmacology department at his university had established links with local hospitals, which enabled his enthusiasm for hospital pharmacy to flourish. “During our undergrad, we were able to go into hospitals and go to consultant clinics. It was very hands-on. That drew my attention to the hospital side of things.”

After completing his pre-registration year in hospital pharmacy, Mr Nugent moved to Guy’s and St Thomas’ NHS Foundation Trust in London to complete a residency. He fondly recalled how he was among 16 newly-qualified pharmacists who worked on-call late at night there. “Effectively it was

Fergus Nugent

mirroring what the junior doctors were doing. We had a senior pharmacist we could call if we got into trouble in the middle of the night. There was a good support structure there and I enjoyed that, not necessarily the calls at 3 o’clock in the morning, but it was a very good education and gave me a really good grounding.”

After about 18 months in London, he decided to move to New Zealand “for a bit of a round-the-world trip” and worked at a hospital in Auckland before returning to London. But it wasn’t long before home beckoned and he moved back to Ireland. “It was time to head back and see what was happening,” he explained. “At that time, it was 2001 or 2002 and we were riding the Celtic Tiger wave, so the country was really prospering and it was an exciting place to come back to.”

Despite the booming economic environment, however, the

opportunities in hospital pharmacy were limited. Mr Nugent moved into community pharmacy, where he spent many years before an opportunity came up 11 years ago at the Mater Private in Cork. He served there as pharmacy manager before becoming Chief Pharmacist five years ago.

“Because I had a hospital background, I was able to get work here. Then once the hospital got to a level where they needed a pharmacy team, they asked me to set it up. Five years later, here we are. I find it quite fulfilling in hospital. It is a bit more on the acute side as opposed to in the community, where it’s more long-term, primary-care focused.”

As head of the hospital’s Pharmacy Department, Mr Nugent manages a team comprising 12 people.

He is Secretary of the Drugs and Therapeutics committee and a member of the QUEST committee of Mater Private Cork. He also holds the position of adjunct lecturer at University College Cork School of Pharmacy.

His hospital role is multifaceted. It is both patient facing and non-patient facing. It involves setting policies and procedures and ensuring standards are maintained. Important aspects of his work include oversight of medication use within the hospital, and working to ensure patient safety.

“Pharmacists by their nature are very careful,” Mr Nugent said. “They are conscientious and they really do want patients to have the best treatment

plan possible. I see that day-in, dayout. The main goal is the same, and it is to optimise patient care. The team here are all very hard-working and I find it really easy to manage them.

“It’s a lovely team. We get great support from the management team within the hospital and as a result, it allows us to use our skills to the best of our ability, to give the best care to patients. The role here for the clinical pharmacy department is to make sure that what is prescribed to inpatients is correct. We advise on administration, be it intravenous drugs or what not, and make sure that discharge prescriptions are correct.

“We also ensure the patient has the information they need to take their medication, and we ensure there is a concordance between the patient and the prescriber and other healthcare professionals on the best course of action.”

The Mater Private Cork has a fully electronic hospital prescribing system, which provides pharmacists with the ability to see in real time when prescriptions are issued. This allows Mr Nugent and his team to “ensure the prescription is correct and appropriate for the patient and optimise safe patient care, that’s the key role from a clinical pharmacy point of view.

“Ultimately, we track medication errors and we have open disclosure and a ‘no blame’ culture within the hospital for any medication error that might occur. For anyone to know the correct doses and get it right all the time is very difficult, but certainly the electronic system helps.”

Medicine shortages

The most challenging aspect of his work, “without doubt”, are medicine shortages. In fact, he believes it is the biggest challenge facing the industry at present. “It’s a huge burden on hospital and community pharmacy. It consumes huge

amounts of time,” he said.

“Most of it is outside our control but, unfortunately, we’re at the forefront and be it a doctor or a patient, or whoever, it can be very difficult to explain the issues around why something has gone short. The challenge is to try to find solutions to that, be it either by using different products or finding a different supply route. It's not getting any better.

“When you’re facing these challenges, it’s really serious and it’s time consuming. It’s not what we want to spend our time doing. Pre-Covid and pre-Brexit, the supply chain was relatively straightforward. There were lots of options. But since Covid and the boom in biologic monoclonal antibodies, the interest and focus on smaller drug molecules has waned. This has been detrimental to patients… the vast majority of medications are consumed by older people who do worry and get anxious about any change to anything in their lives, including medications.”

He maintains that the European Union (EU) needs to take greater action to address the problem.

“It’s not just within Ireland, this is a Europe-wide and worldwide phenomena and really, the EU needs to step up… I think the EU needs to step up and put in a good supply chain mechanism and bring some manufacturing back to Europe to help ensure we have continuity of medicine supply,” he stated.

“We are five years in now and this is not getting any better. It is a huge waste of time for everybody when we could be doing other things and optimising patient care. It’s grinding people down and leading to conflict with colleagues, and also with patients. That leads to huge amounts of stress for community and hospital pharmacists and technicians and really, if this was a short-lived type problem we could grin and bear it, but the pressure is incessant now

and there’s no light at the end of the tunnel for people on this.”

Education and career progression

Challenges for pharmacists are not limited to medication shortages, unfortunately. While the number of colleges offering pharmacy degrees in Ireland has thankfully increased since the mid-1990s, Mr Nugent believes that more student places need to be provided in Ireland.

The structure of pharmacy has changed here in recent years, with more opportunities available for career progression with the introduction of the advanced specialist pharmacist grade.

But, Mr Nugent argued, more training placements in hospitals for pharmacy students are required to enable undergraduates to gain hospital experience. Ireland, he maintained, is lagging behind the UK and other countries on the development of pharmacy departments and pharmacy career progression within hospitals.

“When I was doing my undergraduate degree and went into hospital subsequently, there was actually quite a lot of opportunities to get into hospital pharmacy departments in the UK; pharmacy departments were much more established and much bigger and were 24/7, and maybe that’s where we need to go to eventually in Ireland. We are the medicine experts, so it is something that will in time need to happen,” he said.

“Some 25 years ago in the UK, specialist posts in areas such as chemotherapy and aseptic compounding, for example, were already there in spades. We’re always floating about 15 or 20 years behind the UK, in my experience.”

Having clinical pharmacy training programmes in place in hospitals “is a good thing” as it gives students the chance to undertake placements, he

said. “We take three interns here on rotation and we’re very lucky to get the support of the management team to do that. That has helped us to train and educate young pharmacists and bring them into the hospital and give them that experience.

“A number of them have come back to work within our department after qualifying. I think the common complaint for a lot of hospital pharmacies in Ireland will be that they find it difficult to recruit qualified staff who have hospital experience. I think we have to do a bit better in terms of training staff.

“We really have to get management teams in hospitals to see the benefit of having training programmes. The APPEL system is there, it really is a case of just applying it and you will get people who want to do it. We get 40 candidates, roughly, every single time we go out to the fourth- and fifth-year students, so they want to come — the barrier for them is that there aren't enough training places.

“Within the actual degrees and masters in Ireland, when students

get to third, fourth, and fifth year, the number of opportunities for hospital experiences is limited.”

Another issue for young pharmacists is pay. According to Mr Nugent, hospital pharmacist salaries are significantly smaller than salaries in community pharmacy. “One of the barriers does come down to pay. When you graduate, your community salary versus your hospital salary has quite a large gap.

“That’s a tough choice for someone to make, where you’ve spent five years in college and maybe you’ve got college debt. A huge proportion, probably 70 per cent of pharmacy students, go into community pharmacy when they qualify.

“When you look at your pals in community pharmacy and they’re earning an extra €15,000 or €20,000 a year, then that can be a difficult decision to make. It does level-up as the years go by, but in the initial phase, the salary is a barrier.”

Mr Nugent advised undergraduate and young pharmacists to gain some experience in hospital. This

would, he said, help ensure that any possible future move from community to hospital pharmacy is easier to undertake. “It is an easier transition if you’ve had some hospital experience in your career. It’s easy to go back to hospital. If you only go down the community route, it’s quite a difficult transition to hospital,” he explained.

“It’s a slightly harder transition. It’s not insurmountable and we’ve quite a few who have come here from the community… People shouldn’t be daunted by it, they can transition, but it is just that bit more difficult. For young pharmacists, if they can get some experience within hospitals, it will help them later on.”

Despite the difficulties, however, he believes the future of pharmacy in Ireland is bright and that studying pharmacy offers a rewarding career. Hospital pharmacy departments are only going to expand and get bigger in the future, he said.

“I don’t think there is any hospital department in the country that has got smaller in the last five years. They are only going one way.”

Minister welcomes publication of report on future capacity requirements for public acute hospitals

Minister for Health, Jennifer Carroll MacNeill TD, has welcomed publication of the first of three Health Service Capacity Review reports produced by the ESRI on behalf of the Department of Health. The report projects future demand for public acute hospitals in Ireland to 2040, indicating that a substantial increase in capacity will continue to be required to meet the demands of our growing and ageing population.

ESRI’s independent report sets out acute bed projections to 2040, with a range of 5,091 to 7,780 additional inpatient and day-patient beds required. It also projects an increase in ED attendances of between 333,000 and 444,000 by 2040 from a baseline of 1.6 million, and an increase of 950,000 to 1,298,000 outpatient department attendances from a baseline of 4.56 million.

In 2023, there were 5.3 million

people in Ireland. This is expected to grow by 15 per cent to 6.1 million by 2040. Approximately 87,000 people were aged 85 years and over, projected to more than double by 2040 to 204,000 people. Older age groups tend to use healthcare services more frequently and for longer durations. Bed day rates for males aged 90 years and over are 8,250 per 1,000 population, while females are 6,203 per 1,000

population. This compares to adults under 49, for whom the rates are less than 500 per 1,000 population.

Minister Carroll MacNeill said: “I am grateful to the ESRI for this

report, which highlights the capacity challenges we face in meeting the needs of our growing and ageing population. This evidence base is crucial for future planning, ensuring

we have the facilities to provide the best care to patients. Increasing bed numbers and the necessary resources and workforce requires careful long-term planning.”

Details of EAHP BOOST event announced

The European Association of Hospital Pharmacists (EAHP) has announced the preliminary programme for its BOOST event. This year, BOOST will be held on 14-15 November in Prague, Czech Republic, under the theme ‘Supply Chain Strategies for a Shortage-Free World’.

A keynote speech will be delivered by Joao Francisco Ferreira (European Medicines Agency), who will speak on the topic ‘Value of Real-World Evidence in Managing Medicinal Product Shortages’. Théo Henriet (European Directorate for the

Quality of Medicines & HealthCare) and Maggie Saykall (The European Chemical Industry Council) will deliver a presentation titled ‘Compounding in Times of Shortages – From API to Critical Medicine in Europe’, while Kasper Ernest (European Healthcare Distribution Association) and Tolonen Hanna (Helsinki University Hospital) will present on the topic of ‘Supply Chain Management in Times of Shortages’. Another keynote speech will be delivered on the synergy of the European and the national systems

in managing medicinal product shortages, and the event will also feature interactive workshops, industry satellite sessions, and an SIG session on ‘Interoperability in Automation’. EAHP BOOST is being accredited by the European Council for Pharmacy Education Accreditation (ECPhA) for a maximum of 7 ECPEC. BOOST participants need to attend all sessions and workshops (except the nonECPhA accredited session) to receive their ECPhA accreditation certificate.

For more information, see https:// eahp.eu/education/eahp-boost-2025/.

2025 European Medicine Shortage Survey launched

The 2025 EAHP Shortages Survey is open, the Association has announced. For the first time, the survey covers not only medicines and medical devices, but also compounding practices and critical medicines lists, providing a broader picture of the challenges faced in hospitals.

EAHP is calling on healthcare professionals working in the hospital setting and patients to share their experiences. Your insight is vital in helping to shape effective, long-term solutions to this growing problem, said the EAHP.

“Managing medicines shortages and ensuring continuity of supply

can also cause the diversion of significant amounts of the time and attention of a hospital pharmacist from other tasks important in the provision of high-quality, safe and efficacious care,” said the Association. “Furthermore, the medicines shortage problem can undermine efforts to reduce costs in health systems as often, in the case of shortage, a more costly alternative must be used — or worse, a less effective alternative.”

In 2023, the EAHP conducted its sixth Shortages Survey to assess the scale of the issue. The findings indicated that, as in 2019, 95 per cent

of hospital pharmacists identified medicine shortages as a serious concern. Comparatively, 86 per cent of other healthcare professionals, 84 per cent of physicians, and 68 per cent of nurses also recognised shortages as a significant issue within their hospitals. New questions have been introduced in the 2025 survey to explore the role of compounding in managing medicine shortages and the use of national and European lists of critical medicines.

To take the survey, visit https://www. surveymonkey.com/r/JTGHFDH?utm_ campaign=website&utm_medium=email&utm_source=EAHP25Congress.

Clinical Podcast

EPISODE FOUR TOPIC:

Managing menopause symptoms in general practice

Presented by Dawn O’Shea with Dr Genevieve Ferraris

SCAN HERE TO LISTEN

SPONSORED BY

Respect money, worship time

Fintan Moore on the nationalisation of our income streams

As healthcare professionals, we are in a very trusted position when it comes to how we operate and are quite rightly expected to work legally and ethically, but it’s also essential that we work profitably. At the end of the day, we all need money to keep the world going around. As a general rule, we’re lucky enough in our line of business that if we take care of our patients, then the money will take care of itself but like a lot of general rules, it comes with a few specific caveats. Like any other retailers, we need to buy low and sell high, which is often easier said than done on both sides of the equation.

Regular shortages of medication frequently limit our options on how well we buy, and because the HSE is our main customer, we have no control over what we sell most medication for. In recent years, there has been a creeping nationalisation of our income streams as the DPS threshold has been steadily reduced, and now the pricing of all our contraception and HRT business is also under State control.

For whatever private prescription business still remains, it has never been easier for patients to ‘compare the market’, so price competition will remain keen. Having said all of that, it’s

still important to set prices at a level that respects the associated professional time and input. Personally, I regard my time and that of my employees as a valuable commodity. We have a charge for blister-packing medicines to reflect the time required to prepare them, and I genuinely struggle to fathom why any pharmacy would do them for free. I accept that there can be local competitive pressures if ‘the place down the road’ does them for nothing, but it’s equally likely that they’re only doing them for nothing because you are. If one pharmacy introduces a charge, the other will probably follow suit. Even some of the chains that used to trumpet about doing various free services are steadily rolling in fees to cope with the costs involved.

At the risk of sounding like I’m contradicting myself, I will also throw money at a problem if it saves me time and effort. If there’s a minor shortfall between what the HSE pays for something and the price I have to pay for it, then I’ll take the hit and move on, rather than waste several minutes debating it with the patient. In a perfect world, this shouldn’t happen but Utopia hasn’t arrived yet. I also believe in buying more equipment if it will regularly save even a few seconds. I changed an otherwise perfect Kodak scanner to a Brother because the Kodak

Maybe over the years pharmacists hyper-develop the part of the brain that relates to guesswork

had a stupid power-saving mode, which it took about 15 seconds to wake up from. Even minor things can make a difference — if you regularly have to cross the dispensary to use a stapler, then you probably need to buy another stapler. At the very least, time is money — but it’s actually a lot more valuable.

Local loop

Speaking of saving time, a very useful way to do that is to set up all your local or neighbouring pharmacies as a group on Healthmail, assuming of course that they’re all happy to be included. It takes a little bit of time to get all the various Healthmail addresses and to add them in, but the payback in terms of time saved makes it very worthwhile.

If you’re ever stuck for an item because your order hasn’t arrived or because a hospital has done a Friday-evening special and released a patient on some obscure medication, then you can canvass the neighbourhood with a single email rather than spending the time on the phone. An additional benefit is that it can offer a quick and easy way to circulate a warning regarding forged scripts or known shoplifters circulating in the area.

Chairman of the board game

When it comes to family board games, I’m usually fairly average. I’m reasonably good at Scrabble,

and a bit hit-and-miss with Pictionary. However, we recently had a new addition to the games collection, which is a game called Concept, in which one person has to point to a selection of various pictures and symbols as clues to help the others guess the answer, which can be almost anything, such as a person, book, place or even a phrase.

As an example, for Dora the Explorer, the pictures and symbols pointed to were the ones for humans, small animals, and aeroplanes to indicate that a young person travelled with animals. So far, I’ve won every game we’ve played, and this might be just beginner’s luck, but I’m wondering if it’s because I spend all day in work figuring out what people mean. Patients order medication with vague descriptions of what they need, doctors write vague prescriptions, and customers present with vague symptoms of mystery ailments, so maybe over the years pharmacists hyperdevelop the part of the brain that relates to guesswork. It’s not much of a superpower, but I’ll take it. ●

Fintan Moore graduated as a pharmacist in 1990 from TCD and currently runs a pharmacy in Clondalkin. His email address is: greenparkpharmacy @gmail.com

Different paths, same destination

A good leader recognises that the goal is never to be ‘righter’ than the next person, writes Áine Mac Grory

We return from that brief interlude. I left the reader in suspense while I revelled in my favourite county’s win. I know, priorities, right? Donegal v Cavan… for those of you asking, 3-26 to 1-13. We must move on though. That was ego, this is leadership. There is no place for gloating in leadership.

I have often pondered the role of leadership in pharmacy. From these internal musings I have concluded, much like ego, how much of a role it plays in healthcare. Where multidisciplinary teams are involved, we all desire the credit when we have a positive outcome and equally, we want none of it when it doesn’t.

When communication breaks down, when no-one leads clearly, when too many people try to take charge of the reins, things don’t just become inefficient. They can become damaging.

The real problem isn’t always misinformation. Sometimes, it’s conflicting information — delivered confidently, passionately, and with completely different takes, depending on which professional the patient speaks to.

None of it is necessarily wrong. But together, it feels fragmented. Disjointed.

And the patient, caught in the middle, doesn’t see professional nuance. They see contradiction. They start to doubt everyone. They ask the same question six different ways, hoping to land on a single, unified truth.

This is where leadership really matters. Not because someone needs to ‘win’ the clinical argument, but because someone needs to steer the ship back to clarity.

A good leader recognises that the goal is never to be ‘righter’ than the next person — the goal is to instill confidence. To make the patient feel like the whole team is working from the same page, even

if they took different paths to get there. A good leader will recognise this. A good leader will stay on-task.

Caught out

I’ve been caught out before. I think we have all had those moments.

I often assume that as a pharmacist, the patient has sourced me as their first point of contact, when in fact it is often the reverse.

‘What’s THE BEST thing for a migraine?’ — you enter your basic counselling, and you are met with reluctance to disclose.

Why? Because this is a test. And it is negative marking. That patient came in with an agenda and you didn’t get a copy of the minutes.

The patient has decided to take matters into their own hands and is now trying to gather evidence before they throw the book at us all.

So, here’s muggins yapping at the counter about analgesia and NSAIDs, not realising the person before them is getting more and more irate.

‘That’s not what my neurologist said’ — you realise at that point you never stood a

chance because when that patient came in and asked that question, they didn’t want to hear my response. It was a set-up. An opportunity to unleash their pent-up fury and frustration.

‘I have been suffering from migraines for years now and nobody can tell me why!’

Migraines? Who said anything about migraines?

‘I was on a waiting list for this guy for almost a year and when I finally got to see him, he gave me an antidepressant and a medicine to reduce my blood pressure, And I don’t even have any blood pressure! Can you believe that?’

Do I have the strength not to retort? It’s taken years of practice but in this case, yes. A conversation for another day, I think.

So, here I am. I have options. I’ve been caught off-guard. Raging, I missed the sneak attack. How did I not see that coming? The signs were all there.

Hindsight — let me tell you. If only I could have activated more foresight, eliminating the need for the ‘hind’, and saving my own in the process.

Resign ego

How do I lead effectively here? First, resign ego. Encourage engagement. Offer clarification where possible and reassure the patient about the reason for these clinical decisions, even if they were not my own.

Does this method serve me or the patient? If the answer is the patient, then I can live with this decision. That is a positive outcome, but it is a harder one to achieve.

Having considered the factors that influence leadership, I stumbled upon the theme of unconscious bias. The internal filter that tells us who looks competent. Who sounds authoritative. Who we instinctively trust, and who we don’t.

It operates in the background of every decision we make.

What has that got to do with leadership? Everything. Don’t believe me? How quickly do you form an opinion based on their tone, their confidence, their age… or even their profession? We’re not always aware of these patterns, but they’re powerful — and they can subtly shape how we lead, how we follow, and how we collaborate. Not you? No chance?

Let’s give this a go, if only to prove me wrong. In comes the patient, or advocate for the patient in some cases. You begin your standard counselling, only to be immediately interrupted. “Oh — I know. I’m a N _ _ _ _.”

Did you struggle to fill in the blanks? I have yet to meet a pharmacist who doesn’t resonate with the panic that sets in, and the instant need to double down on the counselling — because that one phrase, delivered with pride and zero hesitation, tells me exactly what’s about to happen next. It’s a classic clash of leaders. The need to assert your authority because in the movie that is your life you are cast as the leader, and you don’t know what other role to play.

I’m not at the stage of being a nanny just yet, but I have seen the role of the matriarch in my own household and when growing up, I knew not to question it.

So, what happens here? Do I respect and recognise this Nanny’s wisdom and position? Of course. Does she respect mine? It’s unclear. Do I want to engage in one big power struggle and mark my territory in this instance? Maybe, yeah. But does that aid in achieving the main goal? No.

I’ve been on the receiving end of that pointed finger and scolding tone far too many times, usually followed by something like, ‘Listen here, young lady, I’ve been pouring boiled olive oil in ears since before you were born.’

Which, while medically concerning, does offer me a small glimmer of joy when the word ‘young’ is used. Fine. I’ll spare Betty her index finger today.

I don’t question that these methods may have been used in the past with no

complaint, but these old wives’ tales are just that. Old. Outdated, and not evidence-based.

No, Nanny Betty, we don’t give a double dose of the yellow-flavoured antibiotic ‘to get it started’.

Back away from the air — that gaping wound needs to be clean and covered.

And no, Coca-Cola and crisps are not an acceptable treatment plan for diarrhoea. Do not get me started on the boiled 7Up.

In this instance, the need to retire the ‘respect your elders’ phenomenon is critical. It might go against the grain to contradict or not submit to that pointed finger, but no more than the need to step back in a multidisciplinary team is necessary for the safety of the patients, so is the need to speak up against one. In another lifetime, one would be taking their lives into their own hands.

Welcome curiosity

If no-one can question the person ‘in charge’, then that person isn’t leading; they’re being enabled. A good leader in any setting, but especially in modern healthcare, welcomes curiosity. They create a culture where it feels safe to ask a question. Where disagreement isn’t seen as insubordination, but as insight. Where a junior team member can say, ‘Are we sure about this?’ without fear of reprimand or ridicule.

That kind of leader doesn’t just tolerate a fresh perspective; they actively seek them out. When every voice around the table looks the same, thinks the same, agrees by default, and shares the same belief system, what you end up with isn’t unity — it’s herd mentality. This is where leadership goes to die, and ego goes to thrive.

A confident leader isn’t threatened by challenge. They know that progress happens when people feel empowered to question, explore, and even disagree — because that’s how you avoid blind spots. That’s how you expand your scope of understanding. And that’s how you find real solutions, not just the most comfortable ones.

I’ve never heard a GP say, ‘I’m basically a pharmacist’. I’ve never seen a consultant imply they could do my job better. And yet, I’ve lost count of how many times my patients say, with good intention, ‘sure, you’re as good as any GP’ and while intended as compliment (which I never shy away from receiving ordinarily), it is one I refuse to accept.

We shouldn’t have to justify our value by borrowing someone else’s title. Pharmacy isn’t a stepping stone. It’s a profession. A field of expertise that patients rely on and healthcare would collapse without.

Understanding the limits of your role doesn’t make you smaller; it makes you smarter.

Surrounding yourself with people who have knowledge, specifically in areas you don’t, is not a threat. It’s a resource. When you engage with them, ask questions, and listen, you don’t lose leadership — you gain depth.

Leadership in community pharmacy isn’t about having all the answers. It’s about knowing when to ask the right questions and when to let someone else answer. It’s not about dominance. It’s about discernment.

And yes, sometimes it’s about standing up to Nanny Betty, and other times it’s about silencing your defence to allow the patient to regain some control.

Let’s keep championing our professions, not as a doctor, not as a nurse (who said anything about nurses?). But proudly, confidently, as pharmacists. ●

Áine is a Superintendent Pharmacist and pharmacy owner with over 18 years of experience working in community pharmacies across Ireland. In 2014, she earned her Master of Pharmacy (MPharm) degree in the UK. Her career journey has encompassed a variety of roles, including locum, support, and supervising, culminating in her recent transition to pharmacy ownership. She is deeply committed to upholding the integrity and vital role of community pharmacy in Ireland, combining her extensive experience with a passion for patient care and professional excellence.

Some like it hot — and it could help their arthritis pain

Dr Des Corrigan looks at the evidence for and against capsaicin for pain relief

The heat I am referring to comes from capsaicin, the pungent chemical from chilli peppers. The fact that we call them ‘peppers’ is down to Christopher Columbus and his merry men who, when they reached the Americas and first came across these fruits, named them after black pepper — with which they were already familiar — due to their hot spicy taste.

There is no capsaicin, which comes from the Latin botanical name C.annuum , in what we call red and green peppers — called bell peppers or simply capsicums in most other countries. Other varieties of this particular species do contain capsaicin and other capsaicinoids and are thus hotter, ie, cayenne and jalapeño peppers. The related species C.frutescens (tabasco and piri-piri) has much hotter chillies and C.chinense produces the hottest chillies of all, including the naga, habanero, and scotch bonnet varieties.

Aficionados vie fiercely with one another to breed the hottest varieties possible. The level of heat, not to mention the intensely painful burning sensation, is a badge of pride and usually expressed as Scoville Heat Units (SHU), named after the American pharmacist who invented the measurement.

Traditionally, SHUs are measured by how much an extract needs to be diluted so that it is undetectable according to a taste panel. Nowadays, quantitative HPLC (high performance liquid chromatography) is used to measure total capsaicinoid content expressed as capsaicin, on the basis that pure capsaicin has an SHU of 16 million.

According to the Guinness Book of Records , the hottest chilli pepper is called Pepper X, with an SHU of 2.69 million, followed by the Carolina Reaper at 2.2 million, the Trinidad Scorpion (1.46 million), and the Naga Viper from Bangladesh (1.38 million). Contrast those values with the (relatively) measly 50,000 SHU for cayenne chillies and 100,000 SHU for the piri-piri variety.

The painful burning sensation that can be caused by chillies, all too familiar to many, is due to the binding of capsaicin to TRVP1 (transient receptor potential cation channel subfamily V member1), the receptor that causes perception of pain and a burning sensation.

However, repeated exposure to capsaicin gives rise to a long-lasting ‘defunctualisation’ or persistent

desensitisation of the receptor, with a subsequent lack of pain perception. It is this property that has attracted medical attention for many years, originally in cases of post-herpetic neuralgia (PHN) associated with shingles.

A Cochrane Review in 2017 looked at the topical use of products containing high concentrations of capsaicin for chronic neuropathic pain in adults. It advised that patches with 8 per cent capsaicin must be applied to the skin under local anaesthetic because of the intense burning sensation caused. Of the eight randomised controlled trials (RCTs) involving 2,488 participants included in the review, two used a placebo control, while the remainder used a 0.04% capsaicin topical product as an active placebo. Four of the studies included patients with PHN.

After 12 weeks, 10 per cent more participants reported being much or very much improved compared to those on the active placebo. Two studies included patients with painful HIV-related neuropathy. In the treatment group, 27 per cent reported that they were much or very much improved compared to 10 per cent on the active placebo.

There was one trial in patients with peripheral diabetic neuropathy in which 10 per cent more participants reported being much or very much improved. While no serious adverse drug reactions were recorded, local effects such as redness, burning, or pain were common. The trials were of moderate or very low quality, according to the reviewers.

In 2023, a more recent systematic review in Pain Management looked at four trials with patches containing 8 per cent capsaicin as well as six RCTs involving either cream or gel formulations in the management of painful diabetic neuropathy. The patches were found to significantly reduce symptoms and improve sleep quality, with a 33 per cent reduction in symptoms after an hour. A cream containing 0.75% capsaicin reduced pain after two weeks but not at week eight, whereas a 0.025% gel gave no reduction in pain.

Over the years, efforts have been made to extend the medicinal use of capsaicin to other conditions. In 2018, the journal Osteoarthritis and Cartilage carried a meta-analysis of RCTs investigating the relative efficacy of capsaicin and non-steroidal anti-inflammatory drugs (NSAIDs) in osteoarthritis. None of the 17 RCTs included a direct comparison between topical NSAIDs and capsaicin. No significant difference in pain relief was seen between topical NSAIDs and capsaicin, with the latter being statistically superior to placebo.

When used as licensed, effect size calculations favoured capsaicin. The authors suggested that a decision

about which to prescribe “should be guided by patient preference, safety, costs, and subsequent individual patient response”. Guidelines from the Osteoarthritis Research Society International and the European League against Rheumatism recommend both equally.

A more recent systematic review and meta-analysis of trials examining the efficacy and safety of topical capsaicin in osteoarthritis treatment appeared in Phytotherapy Research (2024). The evaluation included eight RCTs with 498 patients. The metaanalysis showed that, compared to placebo, capsaicin in concentrations

Over the years, efforts have been made to extend the medicinal use of capsaicin to other conditions

ranging from 0.0125-5% may reduce pain severity as measured with a visual analogue scale. However, the review identified a number of issues with the trials, such as short study periods and small sample sizes resulting in low to very low certainty of the evidence, with the consequent statement that more work was needed.

Capsaicin should not be considered a one-trick pony, as many studies point to its potential in atherosclerosis, metabolic syndrome, and diabetes. A 2024 article in Drug Research reviewed the role of capsaicin in the prevention and treatment of various cancers. It inhibits growth of different types of tumours and induces apoptosis in such cells. An RCT regarding its use for prostate cancer patients is underway in Canada, and combinations of capsaicin and chemotherapy are also under investigation.

The molecule also shows promise in some neurological conditions, especially in animal models of stroke. One RCT of patients with stroke-related dysphagia involved a comparison of capsaicin in tomato juice with a technique called transcutaneous sensory electrical stimulation, and the response rate was higher with capsaicin.

According to a 2022 paper in Molecules , nebulised capsaicin enhanced coughing and sputum excretion in patients who had suffered a haemorrhagic stroke. Meanwhile, capsaicin jelly (0.1%) reduced the severity of migraine and cluster headaches as did an intranasal product but in a small number of patients.

As Joe E Brown’s character famously observes at the end of comedy film classic Some Like it Hot , “nobody’s perfect” and that certainly applies to capsaicin. However, it, and the peppers that produce it, have exciting medical applications as opposed to being solely of interest to culinary sado-masochists. ●

Dr Des Corrigan, Best Contribution in Pharmacy Award (winner), GSK Medical Media Awards 2014, is an Adjunct Associate Professor at the School of Pharmacy and Pharmaceutical Sciences at TCD where he was previously Director and won the Lifetime Achievement Award at the 2009 Pharmacist Awards. He was chair of the Government’s National Advisory Committee on Drugs from 2000 to 2011, having previously chaired the Scientific and Risk Assessment Committees at the EU’s Drugs Agency in Lisbon. He chaired the Advisory Subcommittee on Herbal Medicines and was a member of the Advisory Committee on Human Medicines at the HPRA from 2007 to 2024. He has been a National Expert on Committee 13B (Phytochemistry) at the European Pharmacopoeia in Strasbourg and served on the editorial boards of a number of scientific journals on herbal medicine.

A very important day for public health?

Is obesity a disease, a syndrome or a natural response to an abnormal environment, asks Terry Maguire

Ministerial announcement

In many quarters, there was unrestrained jubilation on the announcement by N Ireland’s Health Minister Mike Nesbitt that he was setting up a Regional Obesity Management Service (ROMS). The community-based service will allow health service access to Wegovy and Mounjaro — better known as the 'skinny-pens', as the headlines ran. Speaking to the BBC at the end of May, the Minister said it was a "very important day for public health". Unfortunately, a superficial reading of the report would have informed the laziest of journalists that skinny pens will not be available on prescription anytime soon, and it was probably not an important day for public health by any stretch of the imagination. What the Consultation Analysis Report on a Proposed ROMS for N Ireland is, is a skilful blocking tactic. It allows our DoH to say it’s doing something about obesity, when it has little intention of doing anything because it doesn’t have the money. With this report, it can duck accusations of denying access to life-saving medicines, as the lobbyists are claiming. The game however has changed, personal responsibility for health is out, mass medicalisation for obesity, it seems, is in and it is coming to the Health Service when budgets permit.

Abuse on the BBC

At the end of last year, I took part in a BBC radio discussion about ‘skinny-pens’. NICE had just published its direction on tirzepatide (Mounjaro) and although the drug is licensed for management of obesity (BMI 30) in the UK, the NHS only funds it for patients with a BMI over 35

plus one weight-related condition — diabetes, hypertension, or sleep apnoea. I suggested to my radio host that using these drugs for “cosmetic purposes” was impacting availability for patients with, for example, diabetes. An expert on the panel was having none of it. All obese patients would benefit from the drugs, he insisted, and the NHS needed to make it more widely available. This would in turn reduce future treatment costs for diabetes, hypertension or sleep apnoea. There were, after all, too many people living with obesity, and obesity is as much a disease as diabetes and hypertension.

It is a seductive argument indeed. Skinny pens Wegovy and Mounjaro are being positioned by vested interests as the solution to our obesity problem. Initially in the ROMS, access will not allow “cosmetic use”, but of course mission creep remains a risk.

The fully-engaged citizen

It’s now over 20 years since retired banker Derek Wanless published his report for the then UK Chancellor of the Exchequer Gordon Brown. Wanless was asked to consider how the NHS might be funded in the future, given its escalating year-

on-year costs. He was not the first to realise that unless individuals take more responsibility for their own health, lose weight, take exercise, stop smoking and reduce stress, a time would come when the NHS would be bankrupted by demand. He predicted that by 2025, diabetes itself would most likely destroy the NHS. You could argue that it does feel that way now that we have arrived.

Wanless promoted the “fully engaged” citizen, actively adopting behaviours to keep healthy and, as a result, reduce NHS costs. It hasn’t really worked out like that, mainly due to a lack of investment in primary prevention and perhaps the wrong advice on diet. The obesity epidemic remains, with some 66 per cent of the population either overweight or obese. The incidence of type 2 diabetes increased by 10 per cent, from three million in 2017, to 3.3 million in 2021.

The wrong dietary advice?

In his book Too Many Pills, doctor and journalist James Le Fanu details a research paper published in 1975 by Dr David Hadden and colleagues from the Royal Victoria Hospital, Belfast. Dr Hadden took 50 patients with type 2 diabetes, split them into two groups, placed one group on a high-fat/lowcarbohydrate diet, and the other group stayed as they were. He recorded significant weight loss at six months in the study group and more importantly, a reversal of some aspects of diabetes. The control groups showed weight increase and worsening of diabetic parameters. His study was ignored because in those days, fat was the enemy, it caused heart disease, and there were no exceptions; everyone had to reduce fat.

To reduce fat, we must increase calories from carbohydrates. This was, and still largely is, government dietary advice and ironically, it may be the main cause of the current obesity crisis.

Low-carb/high-fat diets were ridiculed by medical authorities and banished to the Fad Diet section of high street bookstores and promotional articles in fashion magazines. And I’m not talking about the Dr Atkins Diet, which is too difficult to comply with. Dr Hadden was right, we need to be eating more natural fats and we need improved and updated public messaging on foods with more regulation of processed foods that are disproportionately affecting the health of the less-well-off in society. In the US, Robert Kennedy Jr is, to his credit, doing this.

Dietary advice based on evidence

In his book Why We Eat (too much), bariatric surgeon Andrew Jenkinson updates current scientific thinking on the mistakes in public health messaging on diet. Excessive consumption of processed foods, which are based on simple sugars/ starches (carbohydrates) and vegetable fats, is the problem. This is the Western Diet. Seed-based vegetable fats (not olive oil) contain too many trans-fats and are too high in omega-6-fatty acids. We need a one-to-one ratio (1:1) in our diet for the essential fatty acids, omega-3 and Omega-6. In the Western Diet, it is 1:30. Our body weight is certainly much more complex than calories-in/caloriesout. We each have a ‘weight set-point’, or so the theory goes. The set-point is the weight our bodies aim to maintain and will do so with tireless determination by use of hunger and satiety hormones. Try interfering with your set-point by, for example, going on a calorie-reducing diet, the set-point will kick back and you’ll end up heavier as a result. Dieting does make you fat.

The set-point is determined by our genes, our epigenes, and our environment. For example, the genes in people living in the Middle East who over recent

centuries were subjected regularly to severe famines (and survived) have a genetically selected high set-point and when faced with a Western Diet, pile on the fat. More amazingly, a mother with a normal set-point who is subjected to famine during pregnancy will cause her foetus, by epigenetic processes, to raise his/her set-point because the environment they are about to enter is predicted to be a harsh place where calories are few and far between. This is what was recorded in the Dutch Famine in 1944.

In the Irish population, in common with other European nations, there will be roughly equal numbers of individuals with low, medium and high set-points. Faced with a Western Diet, these will manifest in the statistics that have emerged over the last 40 years, giving us the obesity problem we now face. Onethird are unaffected and remain normal weight, one-third become overweight, and one-third become obese. Resetting our set points requires a significant shift in diet, back to how we lived and ate in the 1970s. That’s perhaps too great a challenge for public health.

A pharmacological solution?

Minister Nesbitt’s ROMS announcement brings N Ireland into line with other UK regions. For England, NICE has allowed NHS prescribing of GLP-1 agonists for patients in Tier 3 and Tier 4 weight management services, mostly specialist centres in hospitals, and which covers about 35,000 patients — not very many, given the 12 million who potentially need treatment. NICE guidance generally applies to N Ireland, so ROMS should now allow us access to these drugs, but how many are we planning to treat?

In June 2023, the UK government announced a pilot to add 40,000 patients to treatment by GPs and to determine Wegovy’s real-World effect. I’m not aware of any outcomes, and I do wonder why.

When these drugs are used as recommended, patients reduce weight by 15-to-20 per cent, and that is really significant. However, when treatment is stopped, the weight returns, questioning

the sustainability of this approach. This certainly means skinny pens do not lower the set-point as 50 per cent of weight loss of muscle tissue, which reduces basal metabolic rate.

On the wrong side of history?

Where debate will continue on whether obesity is a disease, a syndrome or a natural response to an abnormal environment, there remains little disagreement on the causal link between obesity and illness. Yet for obesity, the question of whether a drug or a lifestyle intervention is superior has been, up until now, in favour of lifestyle intervention; better diet and increased activity have been proved effective in reducing morbidity and mortality. To say it should be both drugs and lifestyle is naive and suggests we really don’t appreciate how these potent satiety drugs work.

Losing weight is difficult and perhaps too many people struggle to achieve meaningful targets. Individuals with insulin resistance, for instance, have been shown to lose weight only half as successfully as others by whichever means is attempted. I have no issue with using these drugs in patients with diabetes.

I might find myself on the wrong side of history in this debate, but I do feel it perverse that ‘skinny-pens’ are being positioned as a key solution to our obesity problem. I worry about mass medicalisation, because ‘moral hazard’ is writ-large across this policy trend. With these drugs there is no need to change, alter food intake, or to bother taking exercise.

A ROMS with an emphasis on satiety agonist drugs is a dystopian future, and one that would have Derek Wanless and David Hadden turning in their graves. ●

Terry Maguire owns two pharmacies in Belfast. He is an honorary senior lecturer at the School of Pharmacy, Queen’s University Belfast. His research interests include the contribution of community pharmacy to improving public health.

The many facets of fatigue

Damien O’Brien MPSI on the different types of fatigue and how patients can get back on the road to recovery

Introduction

Fatigue is a common complaint encountered in both primary and secondary care. It is a complex and multifaceted symptom characterised by a persistent sense of exhaustion or lack of energy. Fatigue often persists despite usual strategies for restoring energy and can impair an individual’s ability to carry out their daily activities. Although often equated with tiredness, fatigue is a more complex and multifaceted condition. It may be both a symptom and a syndrome, often without a clear organic cause, and can have a significant impact on daily functioning, productivity, emotional wellbeing, relationships, and quality of life.

Fatigue can be broadly described as physical, mental, or emotional in nature. Physical fatigue involves muscle weakness, reduced physical performance, and low stamina. Mental fatigue is marked by decreased cognitive functioning, such as difficulty concentrating and memory issues. Emotional fatigue is characterised by low motivation and apathy. This article aims to explore fatigue from a pharmacist’s perspective — discussing its classification, causes, evaluation, pharmacological management, and

non-pharmacological interventions. The role of the pharmacist has extended beyond medication dispensing to include the assessment and management of symptoms, ensuring a holistic approach to patient care.

Fatigue can be broadly categorised into acute fatigue and chronic fatigue. Acute fatigue is generally self-limiting and often results from identifiable causes such as overexertion, temporary sleep disturbances, or acute illness. Chronic fatigue is defined as persistent fatigue lasting longer than six months. It may be indicative of chronic medical conditions or psychological disorders.

Aetiology

The aetiology is multifactorial, encompassing a wide range of physiological, psychological, environmental, and lifestyle factors.

Understanding the root cause is important in managing fatigue effectively.

Medication-induced fatigue

Many medications list fatigue as a known adverse effect. Beta-blockers decrease cardiac output, which may result in reduced energy levels. Sedative drugs, including antihistamines, antidepressants, benzodiazepines, antipsychotics, opioids, and antiParkinsonian drugs, have central nervous system depressant effects and may cause fatigue. Chemotherapeutic agents can induce fatigue through various mechanisms, including anaemia and effects on the central nervous system. Substance abuse disorders, including alcoholism, may also contribute to fatigue.

Pharmacists are uniquely positioned to identify medication-induced

fatigue during routine medication reviews. They can collaborate with other healthcare professionals to deprescribe, adjust dosages, or switch medications when appropriate.

Physiological causes

Fatigue is often secondary to an underlying medical condition, with many chronic medical conditions being significant contributors. Both type 1 and type 2 diabetes can lead to fatigue due to fluctuating blood glucose levels. Other endocrine disorders, such as hypothyroidism, often cause fatigue, as slower metabolic processes can reduce energy levels.

Anaemia is a common cause of fatigue, in which the body lacks sufficient red blood cells, leading to reduced oxygen delivery to tissues. Anaemia may result from iron deficiency, vitamin B12 deficiency, or chronic conditions such as kidney disease. Heart conditions, including congestive heart failure and coronary artery disease, may also contribute to fatigue due to impaired oxygenation and nutrient delivery. Sleep apnoea can lead to poorquality sleep and persistent daytime fatigue. Chronic infections, such as hepatitis, human immunodeficiency virus (HIV), and tuberculosis, can also cause systemic fatigue.

Chronic fatigue syndrome (CFS) is a complex, debilitating disorder characterised by persistent fatigue that is not alleviated by rest and is worsened by physical or mental activity, significantly impairing daily functioning and quality of life. The exact aetiology is unclear, but a combination of factors — including immune system dysregulation, viral infections, and stress — may play a role. Patients typically present with persistent fatigue, unrefreshing sleep, post-exertional malaise, and cognitive impairments. Additional symptoms may include orthostatic intolerance, muscle pain, and headaches. Diagnosis is typically clinical, based on patient history and

symptoms, as there are no definitive laboratory tests, and the exclusion of other medical conditions is essential.

Psychological factors

Fatigue often arises from psychological origins, overlapping with mental health conditions such as depression, anxiety, and stress-related disorders. It is often one of the presenting symptoms of depression, with patients experiencing persistent low energy, reduced cognition, and low motivation, regardless of levels of physical activity. Anxiety disorders may present with sustained hyperarousal and sleep disturbances, leading to daytime fatigue. Chronic stress, whether from personal trauma or burnout, can result in hormonal imbalances that manifest as physical exhaustion.

Lifestyle and environmental factors

Fatigue is often influenced by modifiable lifestyle and environmental factors that can be addressed to improve energy levels and overall wellbeing. Leading a sedentary lifestyle is associated with increased fatigue. Inadequate nutrition can contribute to fatigue, with a high intake of processed foods and a low intake of fruits and vegetables leading to nutritional deficiencies. Furthermore, excessive alcohol consumption and smoking have been linked to increased fatigue levels. High caffeine intake can also impair sleep quality and energy levels. Sleep quality is another important factor: Poor sleep hygiene, irregular sleep patterns, and insufficient sleep duration can all contribute to persistent fatigue.

Assessment and diagnosis

Accurate assessment of fatigue involves a comprehensive evaluation of the patient’s medical history, medication regimen, lifestyle, and psychological state. Detailed medication reviews are important for identifying potential medication-related causes of fatigue. History-taking and

Pharmacists are uniquely positioned to identify medicationinduced fatigue during routine medication reviews

physical examination should focus on identifying common secondary causes, as well as life-threatening conditions such as cancer. Laboratory testing is useful to assess for anaemia, thyroid dysfunction, and other conditions. Women of childbearing age should undergo a pregnancy test. Standardised assessment tools can help quantify fatigue levels and monitor response to treatment.

Pharmacological management

Pharmacological treatment of fatigue should be personalised, focusing on addressing underlying conditions and providing symptom relief. Its management necessitates a comprehensive approach. While non-pharmacological interventions remain the cornerstone of treatment, pharmacological options can play an important role in alleviating fatigue when tailored to each patient’s needs. A cautious approach is often warranted due to the limited efficacy and potential risks associated with certain medications.

In the case of CFS, the National Institute for Health and Care Excellence (NICE) guidelines emphasise a cautious and individualised approach to pharmacological interventions. The use of medication as a curative treatment is discouraged. Pharmacological strategies focus on symptom management, taking sensitivities and potential adverse effects into account. Starting medications at lower doses

and titrating slowly is recommended to enhance tolerability.

Antidepressants can play an important role in the treatment of fatigue in certain cases, particularly where it coexists with mood disorders. Selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and other antidepressants may alleviate fatigue by addressing underlying depression or anxiety. However, the effectiveness of antidepressants specifically on fatigue symptoms is uncertain, and they should be used only following a comprehensive evaluation of the patient’s mental health status.

Central nervous system stimulants, including modafinil and methylphenidate, are sometimes used to reduce fatigue, particularly in conditions such as multiple sclerosis and cancer-related fatigue. These drugs promote wakefulness and enhance cognitive function. However, evidence for their efficacy is mixed, and there is potential for adverse effects such as insomnia and cardiovascular complications. Their use is off-label and not recommended in the NICE guidelines for routine fatigue management.

Corticosteroids, such as dexamethasone, are occasionally used to provide temporary relief from fatigue, particularly in cancer patients. However, long-term use is discouraged due to adverse effects, including immunosuppression, osteoporosis, increased infection r isk, and adrenal insufficiency.

Non-pharmacological management

There are a range of nonpharmacological interventions that are important in the management of fatigue. In some cases, they may offer a lowcost treatment option that can be used as monotherapy or in combination with pharmacological treatment.

Cognitive behavioural therapy

Cognitive behaviour therapy (CBT) is an evidence-based approach that

addresses the psychological aspects of fatigue. It has effectiveness in reducing fatigue symptoms in various conditions, including CFS, depression, and anxiety. CBT helps identify and modify maladaptive behaviours that may contribute to fatigue. Patients can develop coping strategies, improve sleep patterns, and reduce fatigue using this method. NICE guidelines state that CBT is not curative for CFS but may support patients in managing their symptoms, improving functioning, and reducing distress.

Sleep hygiene

Sleep hygiene refers to behavioural and environmental practices that promote high-quality sleep. Promoting good sleep hygiene is crucial in managing fatigue. This involves maintaining a regular sleep schedule, creating a restful sleep environment, limiting screen exposure in the evening, and avoiding stimulants before bedtime. Poor-quality sleep is a major contributor to daytime fatigue, and small improvements in sleep quality can significantly impact energy levels and cognitive performance.

Nutrition and hydration

Optimising nutrition and hydration are fundamental in managing fatigue, especially when underlying deficiencies are contributing factors. A balanced diet rich in whole grains, lean protein, fruits, and vegetables provides essential nutrients that support energy metabolism. Deficiencies in iron and vitamins often cause fatigue and should be assessed and corrected where necessary. The intake of nutrient-dense foods and, when appropriate, supplementation can help address these deficiencies. This is emphasised in the NICE guidelines, and referral to a dietitian may be required in certain cases.

Coenzyme Q10 (CoQ10) is a mitochondrial cofactor involved in adenosine triphosphate (ATP) production and may play a role in reducing fatigue. Studies have

shown that CoQ10 supplementation is effective and safe for alleviating fatigue symptoms, with greater benefits observed at higher doses and with longer treatment durations. Doses typically range from 100mg to 200mg daily, and adverse effects are rare, though mild gastrointestinal discomfort may occur.

Hydration is also vital in the management of fatigue. Even mild dehydration can impair physical performance, cognitive function, and mood, thereby exacerbating feelings of fatigue. Ensuring adequate fluid intake supports optimal physiological function and energy levels. Fluid intake should be individualised based on personal needs, activity levels, and environmental conditions.

Role of the pharmacist

Fatigue is a multifaceted and complex condition, requiring a multidisciplinary approach to management.

Pharmacists are accessible healthcare professionals who play a critical role in identifying contributing factors, optimising pharmacological management, and guiding nonpharmacological interventions. They may identify and mitigate drug-induced fatigue by adjusting dosages, switching medications, or deprescribing when appropriate.

Pharmacists may also help manage fatigue symptoms using over-the-counter options, including iron, vitamin B12, or caffeine supplementation. Additionally, they can counsel patients on lifestyle modifications and emphasise the importance of adherence to prescribed treatment plans.

Pharmacists collaborate closely with other healthcare professionals to develop comprehensive care plans that address the multifactorial nature of fatigue, ultimately helping individuals manage and overcome fatigue to improve their overall health and quality of life. ●

References available on request

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Controlling cholesterol

Eamonn Brady MPSI looks at the role of cholesterol in the body and how it can be managed to prevent a number of serious conditions

Cholesterol is a lipid (fat). It is manufactured by the liver from the fatty foods that we eat, and plays a vital part in allowing the body to function normally. Cholesterol is present in the membrane (outer layer) of every cell in the body. It insulates nerve fibres and is an essential building block for hormones, such as the sex hormones, and the hormones of the adrenal cortex. It also enables the body to produce bile salts.

Cholesterol is carried in the blood by molecules called lipoproteins. There are

several different lipoproteins, but the three main types are:

f Low density lipoprotein (LDL). This is often known as ‘bad cholesterol’ and is thought to promote arterial disease. It carries cholesterol from the liver to the cells and can cause a harmful build-up if there is too much for the cells to use. Normally, the blood contains about 70 per cent of LDL but the level will vary from person-to-person. The recommended LDL level is below 3.37mmol/l.

f High density lipoprotein (HDL). This is often referred to as ‘good cholester-

ol’, and is thought to prevent arterial disease. It takes cholesterol away from the cells and back to the liver, where it is either broken down or is passed from the body as a waste product. Recommended HDL range is 1.45-4mmol/l.

f Triglycerides are another type of fatty substance present in the blood. They are found in dairy products, meat, and cooking oils. Triglycerides are also produced by the liver. Those who are overweight, have a diet that is high in fatty or sugary foods, or drink a large amount of alcohol, have an increased risk of having a high

triglyceride level. Recommended triglyceride level is below 1.71mmol/L.

The amount of cholesterol present in the blood can range from 3.6-7.8mmol/l. A level above 6mmol/l is considered high, and a risk factor for arterial disease. A total cholesterol level of below 5.2mmol/l is recommended to prevent heart disease.

Evidence strongly indicates that high cholesterol levels can cause narrowing of the arteries (atherosclerosis), heart attacks, and strokes. The risk of coronary heart disease also rises as blood cholesterol levels increase. If other risk factors, such as high blood pressure and smoking, are present, the risk increases even more.

High cholesterol is not a disease in itself, but it is linked to serious conditions, such as cardiovascular illness, angina, stroke, and mini-stroke

Symptoms

High cholesterol is not a disease in itself, but it is linked to serious conditions, such as cardiovascular conditions, angina, stroke, and mini-stroke, known as transient ischaemic attack (TIA). A high level of cholesterol in the blood, together with a high level of triglycerides, can increase the risk of developing coronary heart disease. Coronary heart disease is caused by a narrowing of the arteries that supply the heart with blood. This narrowing of the arteries is called atherosclerosis. Fatty deposits, such as cholesterol, cellular waste products, calcium, and other substances build up in the inner lining of an artery. This build-up, known as plaque, usually affects small and medium-sized arteries. The flow of blood through the arteries is restricted as the inside diam-

eter is reduced. Blood clots, which often happen in the coronary arteries during a heart attack, are more likely to develop when arterial walls are roughened by the build-up of fatty deposits.

A high cholesterol level may only be revealed with symptoms of atherosclerosis. These can include:

f Angina: Caused by narrowed coronary arteries in the heart.

f Leg pain on exercising: Due to narrowing of the arteries that supply the lower limbs.

f Blood clots and ruptured blood vessels: Can result in a stroke or mini stroke/TIA.

f Ruptured plaques: Can lead to a blood clot forming in one of the arteries delivering blood to the heart (coronary thrombosis), and may lead to heart failure if a significant amount of heart muscle is damaged.

f Thick yellow patches (xanthomas): Seen around the eyes or elsewhere on the skin. These are cholesterol deposits and can often be observed in people with inherited or familial cholesterol (where close family members have a history of high cholesterol).

Causes

A number of different factors can contribute to high blood cholesterol:

1. Lifestyle risk factors

There are a number of preventable lifestyle-related risk factors that can increase the risk of developing high blood cholesterol.

They include:

f Unhealthy diet: Some foods contain cholesterol – known as dietary cholesterol – for example, liver, kidneys, and eggs. However, dietary cholesterol has little effect on blood cholesterol. More important is the amount of saturated fat in the diet. Foods that are high in saturated fat include red meat, meat pies, sausages, hard cheese, butter and lard, pastry, cakes, biscuits, and cream, such as soured cream and crème fraiche.

f Lack of exercise or physical activity: Can increase level of bad cholesterol

(LDL) and decrease level of good cholesterol (HDL).

f Obesity: Being overweight means an increased risk of high LDL and a decreased level of HDL, increasing overall blood cholesterol level.

f Smoking.

f Drinking excessive amounts of alcohol: The recommended amount is three-to-four units a day for men, and two-to-three units a day for women.

2. Treatable risk factors

f Hypertension.

f Diabetes.

f A high triglyceride blood level.

f Medical conditions: Kidney and liver diseases, and an under-active thyroid gland.

3. Fixed risk factors

f A family history of heart disease or stroke: A person is more likely to have high cholesterol if a close male relative (father or brother) aged under 55, or a female relative (mother or sister) aged under 65, has been affected by coronary heart disease or stroke.

f A family history of cholesterol-related conditions: For example, if a close relative, such as a parent, brother, or sister has familial hypercholesterolaemia, or combined hyperlipidaemia.

f Being male: Men are more at risk of having high blood cholesterol than women.

f Age: The older we get, the greater the likelihood of developing atherosclerosis.

f Early menopause in women.

f Ethnic group: People who are of Indian, Pakistani, Bangladeshi, or Sri Lankan descent have an increased risk of high blood cholesterol.

If a patient has a fixed risk factor (or several fixed risk factors), it is even more important to take steps to address any lifestyle or treatable risk factors.

Reduction in death rate from CHD in Ireland over the last 35 years

According to research published in the Journal of Epidemiology and Community

Health in 2006, changes in three classic cardiovascular risk factors (smoking, cholesterol, and blood pressure) contributed to a 61.9 per cent decrease of total coronary heart disease (CHD) mortality in Ireland between 1985 and 2000. This was consistent with studies in other developed countries.

In Ireland in 2000, heart disease was the leading cause of death, being responsible for 41 per cent of all deaths. In 2020, Central Statistics Office (CSO) figures show that diseases of the circulatory system (which includes CHD) were responsible for 26.3 per cent of all deaths. Smoking reduction, better diagnosis of cholesterol and hypertension, and better and earlier treatment interventions are all important factors contributing to this drop in deaths from heart disease. The better availability and affordability of statins in controlling cholesterol is also seen as a major factor that has reduced deaths from CHD.

Diagnosis

To measure cholesterol, a simple blood test is often carried out. Before the test is done, it is best not to eat for 12 hours (usually including the night-time when asleep). This ensures that all food is completely digested and will not affect the outcome of the test. A GP, practice nurse, or pharmacist can carry out the blood test. They will take a sample by either using a needle and a syringe or by pricking a finger.

The blood sample that is taken will be used to determine the amount of LDL (bad cholesterol), HDL (good cholesterol), and triglycerides in blood. Blood cholesterol is measured in units called millimoles per litre of blood (mmol/l). It is recommended a total blood cholesterol level of less than 5mmol/l, and an LDL cholesterol level of under 3mmol/l.

Anyone can have their blood cholesterol level tested, but it is particularly important to have it checked if you: f Are aged over 40.

f Have a family history of cardiovascular disease: For example, if your father or brother developed heart disease, or had

a heart attack, or a stroke before the age of 55, or if your mother or sister had these conditions before the age of 65.

f Have a close family member has a cholesterol-related condition: Examples include familial hypercholesterolaemia or combined hyperlipidaemia.

f Are overweight or obese.

f Have high blood pressure (hypertension).

f Have a medical condition: Examples include a kidney condition, an under-active thyroid gland, or acute inflammation of the pancreas (acute pancreatitis). This is because these conditions can cause an increased level of cholesterol.

In assessing risk of cardiovascular disease, heart attack, or stroke, cholesterol ratio should not be taken on its own. Lifestyle factors should also be taken into consideration. For example:

f Smoking.

f Diet.

f BMI (body mass index or weight in relation to height).

f Treatable risk factors, such as high blood pressure and diabetes.

f Fixed risk factors, such as age, sex, and ethnicity.

Complications of high cholesterol

High cholesterol levels can be made worse by other medical conditions such as an under-active thyroid gland, an overactive pituitary gland, liver disease, or kidney failure.

Some people have inherited disorders, such as familial hypercholesterolaemia, or combined hyperlipidaemia, that prevent fats from being used properly and eliminated from the body. This allows the level of cholesterol to build up in the blood.

The major complications of raised blood cholesterol are heart attacks, strokes, and arterial disease. The risks of all of these are increased if the patient is/has:

f Overweight.

f A smoker.

f High blood pressure.

f A strong family history of these conditions.

f Diabetic.

Prevention

Patients can prevent high blood cholesterol by eating a healthy, balanced diet that is low in saturated fat. Including a small amount of unsaturated fats in the diet is a healthy choice, as this type of fat can actually reduce cholesterol levels. Current thinking is that the traditional Mediterranean diet, with its emphasis on raw olive oil in many foods, and low animal-fat content, is effective in ensuring cardiovascular health.

Foods high in unsaturated fats include: f Oily fish.

f Avocados.

f Nuts and seeds.

f Sunflower, rapeseed, and olive oil.

f Vegetable oils.

Treatment

When diagnosed with high cholesterol, the first method of treatment will usually involve making dietary changes (adopting a low-fat diet), and ensuring plenty of regular exercise. After a few months, if the cholesterol level has not dropped, the advice may be to take cholesterol-lowering medication.

Diet

It is important to ensure a healthy diet by changing to one that is low in saturated fats which can reduce the level of LDL or bad cholesterol. If the person is in a high-risk category of getting cardiovascular disease, altering his or her diet will not lower risk sufficiently. A healthy diet includes foods from all different food groups including carbohydrates (cereals, wholegrain bread, potato, rice, and pasta), proteins (for example, from lean meat, such as chicken, and oily fish, like mackerel or sardines), and fats (varieties that are unsaturated, such as low-fat, mono- or poly-unsaturated spreads, and vegetable or sunflower oil). At least five portions of a variety of different fruit and vegetables should be eaten daily.

Cholesterol-lowering medication

There are several different types of cholesterol-lowering medication which work

GO BEYOND LOWERING LDL-C

ADD ON TO REDUCE CV RISK

When statins* and ezetimibe are not enough, add on once daily oral bempedoic acid earlier, to help your patients go even further.1,2Δ

* Concomitant use with simvastatin >40 mg daily is contraindicated; please refer to the relevant SmPC for more information.1,2

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

NILEMDO (bempedoic acid) 180 mg / NUSTENDI (bempedoic acid/ezetimibe) 180 mg/10 mg film-coated tablets

Abbreviated Prescribing Information   Refer to Summary of Product Characteristics (SmPC) prior to prescribing. Presentation: Each Nilemdo film-coated tablet contains 180 mg bempedoic acid. Each Nustendi filmcoated tablet contains 180 mg of bempedoic acid and 10 mg of ezetimibe. Indications: Hypercholesterolaemia and mixed dyslipidaemia: Nilemdo/Nustendi are indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet: In combination with a statin (Nilemdo: or statin with other lipid-lowering therapies) in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin; alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant; or for whom a statin is contraindicated (Nustendi: and are unable to reach LDL-C goals with ezetimibe alone). Cardiovascular disease: In adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in patients on a maximum tolerated dose of a statin with or without ezetimibe or; alone in patients who are either statin-intolerant, or for whom a statin is contraindicated (Nustendi: or in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.) Posology and method of administration: The recommended dose is one tablet of 180 mg Nilemdo or 180 mg/10 mg Nustendi taken once daily, with or without food. Tablet should be swallowed whole. Concomitant simvastatin therapy: When Nilemdo/Nustendi are coadministered with simvastatin, simvastatin dose should be limited to 20 mg daily (or 40 mg daily for patients with severe hypercholesterolaemia and high risk for cardiovascular complications, who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks). Coadministration with bile acid sequestrants: Dosing of Nustendi should occur either at least 2 hours before or at least 4 hours after administration of a bile acid sequestrant. Paediatric Population: The safety and efficacy of Nilemdo/Nustendi in children aged less than 18 years have not yet been established. Contraindications: Hypersensitivity to the active substance or any of the excipients (see SmPC); pregnancy; breast-feeding; concomitant use with simvastatin > 40 mg daily. When Nustendi is co-administered with statin in patients with active liver disease or unexplained persistent elevations in serum transaminases; when Nustendi is co-administered with a statin, consult the SmPC for that particular statin therapy. Warnings and precautions: Potential risk of myopathy with concomitant statins: Bempedoic acid increases plasma concentrations of statins. Patients receiving Nilemdo and a statin should be monitored for adverse reactions that are associated with high doses of statins. Statins occasionally cause myopathy. In rare cases, myopathy may take the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria and can lead to fatality. In post marketing experience with ezetimibe, very rare cases of myopathy and rhabdomyolysis were reported. Most patients who developed rhabdomyolysis were taking a statin with ezetimibe. Patients receiving Nilemdo/ Nustendi and a statin should be advised of the potential increased risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness. If such symptoms occur, a lower maximum dose of the same statin or an alternative statin, or discontinuation of Nilemdo/Nustendi and initiation of an alternative lipid-lowering therapy should be considered under close monitoring of lipid levels and adverse reactions. If myopathy is confirmed by creatine phosphokinase (CPK) > 10× upper limit of normal (ULN), immediately discontinue Nilemdo/ Nustendi and any statin. Increased serum uric acid: Bempedoic acid may raise serum uric acid due to inhibition of renal tubular OAT2 and may cause or exacerbate hyperuricaemia and precipitate gout in patients with history of gout or predisposed to gout. Discontinue Nilemdo/Nustendi if hyperuricaemia accompanied with symptoms of gout appear. Elevated liver enzymes: Liver function tests should be performed at initiation of therapy. Discontinue

Nilemdo/Nustendi if increase in transaminases > 3× ULN persists. Renal impairment: Additional monitoring for adverse reactions may be warranted in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) or patients with ESRD on dialysis. Hepatic impairment: Periodic liver function tests should be considered for patients with severe hepatic impairment (Child-Pugh C) taking Nilemdo. Nustendi is not recommended in moderate to severe hepatic impairment (Child-Pugh B and C) due to unknown effects of increased exposure to ezetimibe. Fibrates: If cholelithiasis is suspected in a patient receiving Nustendi and fenofibrate, gallbladder investigations are indicated, and therapy should be discontinued. Ciclosporin: Caution when initiating Nustendi in the setting of ciclosporin. Ciclosporin concentrations should be monitored. Anticoagulants: Appropriately monitor INR if Nustendi is added to warfarin, other coumarin anticoagulants, or fluindione. Contraception measures in women of childbearing potential: Before initiating treatment in women of child-bearing potential appropriate advice on effective methods of contraception should be provided, and effective contraception initiated. Patients taking oestrogen-based oral contraceptives should be advised to stop Nilemdo/Nustendi before stopping contraceptive measures if planning to become pregnant. Excipients: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take Nilemdo/Nustendi as it contains lactose. Patients at high risk of cardiovascular disease: Evidence for the use of the fixed combination medicinal product of bempedoic acid with ezetimibe in patients at high risk of cardiovascular disease is only available for the lipid-lowering effect in absence of any cardiovascular risk reduction estimation for ezetimibe in primary prevention patients. Driving and use of machines: Nustendi has minor influence on ability to drive and use machines. Dizziness has been reported. Interaction with other medicinal products: Refer to SmPC for full information on interactions. Adverse reactions: Nilemdo: Common (≥ 1/100 to < 1/10): Glomerular filtration rate decreased, anaemia, gout, hyperuricaemia (includes blood uric acid increased), AST increased, pain in extremity. Uncommon (≥ 1/1,000 to < 1/100): weight decreased, haemoglobin decreased, ALT increased, liver function test increased, blood creatinine increased, blood urea increased, Consult Nilemdo SmPC in relation to other adverse reactions. Nustendi: Common (≥ 1/100 to < 1/10): Glomerular filtration rate decreased, anaemia, decreased haemoglobin, hyperuricaemia (includes uric acid increased), decreased appetite, dizziness, headache, hypertension, cough, constipation diarrhoea, abdominal pain, nausea, dry mouth, flatulence, gastritis, liver function test increased (includes liver function test abnormal), back pain, muscle spasms, myalgia, pain in extremity, arthralgia, blood creatinine increased, fatigue, asthenia, gout, AST increased (for bempedoic acid), blood CPK increased. Uncommon (≥ 1/1,000 to < 1/100): weight decreased, ALT increased, blood urea increased, hot flush, dyspepsia, gastrooesophageal reflux disease, AST increased (for ezetimibe), GGT increased, pruritus (with statin), neck pain, muscular weakness (with statin), chest pain, pain, oedema peripheral (with statin). Frequency not known: Thrombocytopaenia, hypersensitivity (including rash, urticaria, anaphylaxis, angio-oedema), depression, paraesthesia (with statin), dyspnoea, pancreatitis, hepatitis, cholelithiasis, cholecystitis, erythema multiform, myopathy / rhabdomyolysis. Consult Nustendi SmPC in relation to other adverse reactions. Legal Classification: POM. Package quantity, marketing authorisation (MA) number: Nilemdo 28 tablets: EU/1/20/1425/002. Nustendi 28 tablets: EU/1/20/1424/002. MA Holder: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany. Further information available on request from Daiichi Sankyo Ireland Ltd. D09 YF97. Telephone: (01) 489 3000. Fax: (01) 489 3033. Email: medinfo@daiichi-sankyo.ie Date of Preparation: December 2024. JOB ID: IE/BEM/12/24/0005.

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

References: 1. NILEMDO®. Summary of Product Characteristics. Available from: https://www.medicines.ie/medicines/nilemdo-180mg-film-coated-tablets-36336/spc [Accessed December 2024]. 2. NUSTENDI®. Summary of Product Characteristics. Available from: https://www.medicines.ie/medicines/nustendi-180mg-10mg-film-coated-tablets-36337/spc [Accessed Date: December 2024] . IE/BEM/12/24/0010 | Date of preparation: January 2025

in different ways. Commonly prescribed medication includes:

f Statins (HMG-CoA reductase inhibitors), such as simvastatin and atorvastatin, work by blocking the enzyme (chemical) in the liver that is needed to make cholesterol. Statins are used to reduce cholesterol to less than 4mmol/l and LDL cholesterol to less than 2mmol/l. They are, therefore, useful in preventing and treating atherosclerosis which can cause chest pain, heart attacks, and strokes. Statins sometimes have mild side-effects which can include constipation, diarrhoea, headaches, and abdominal pain.

f Aspirin may be recommended, depending on age and several other factors. A low daily dose of aspirin can prevent blood clots from forming. (Children under 16 years should not take aspirin).

f Niacin is a B vitamin that is found in foods and in multivitamin supplements. In high doses, available by prescription, niacin lowers LDL cholesterol and raises HDL cholesterol. Minor side-effects include flushing or tingling skin, itching, and headaches. More research is needed to prove the effectiveness of niacins in reducing cholesterol.

f Other medications , such as cholesterol absorption inhibitors (ezetimibe), and bile-acid sequestrants (ie, cholestyramine), are sometimes used to treat high cholesterol. However, bile-acid sequestrants may be less effective than other forms of treatment and have more side-effects. PCSK9 inhibitors are a new type of cholesterol medication for resistantly high cholesterol administered subcutaneously either every two weeks or monthly.

If the patient has high blood pressure (hypertension), the GP may also prescribe medication to lower it.

Statins

Statins are the world’s most prescribed drugs and are an effective medication in reducing cholesterol in most patients. There are several types of statins on the market, but they all work in the same way. Examples include atorvastatin,

Table 1: Statin intensity table (NHS England) *

*Table 1: Statin intensity table is from NHS England (Summary of National Guidance for Lipid Management for Primary and Secondary Prevention of CVD)

pravastatin, rosuvastatin, simvastatin, and fluvastatin.

Statins are only available with a doctor’s prescription in Ireland. Since 2004, simvastatin 10mg has been available over the counter (OTC) in pharmacies in the UK; however, it is sold under strict guidelines under the supervision of the pharmacist, and the patient must meet specific criteria. For example, patients targeted are those at a 10 per cent to 15 per cent risk of an event in 10 years. Clinical trials show that statins are very effective at reducing cholesterol and hence heart disease. Statins are one of the major reasons for the significant fall in death rate from heart disease in Ireland since they were first launched more than 30 years ago. Statins work by blocking the enzyme HMG-CoA reductase, which plays an important role in the production of cholesterol in the liver. They are therefore useful in preventing and treating atherosclerosis which can cause chest pain, heart attacks, strokes,

and cardiac deaths.

Most statins must be taken at night, as most cholesterol is made while we sleep. The only statin which does not have to be taken at night is atorvastatin, which can be taken morning or night. Statins are more effective in reducing LDL cholesterol than other cholesterol medication.

How effective are statins?

A study published in the British Medical Journal in 2003 showed that, on average, statins reduce LDL cholesterol by 1.8mmol/l. This resulted in a 60 per cent reduction in the risk of cardiovascular events such as heart attacks, clots, and sudden cardiac death – and a 17 per cent reduction in the risk of stroke.

Which statin is best?

No major study has shown one statin to be significantly more effective than others. The CURVEs study in America in 1998 indicated that atorvastatin was

more effective than other statins at lowering cholesterol and this was one of the major reasons that atorvastatin became the most prescribed statin in the intervening years, and Lipitor became a ‘blockbuster’ drug for Pfizer.

However, the effectiveness of atorvastatin over other statins has been somewhat discounted since – for example, another study published in the American Heart Journal in 2006 showed that there was no significant difference between atorvastatin and other statins (simvastatin and pravastatin) at reducing heart disease. A study published in the International Journal of Endocrinology and Metabolism in 2017 (the study was on an Asian population) indicated that the effects of statins on a patient’s lipid profile are dose-dependent and showed that rosuvastatin has the best effect on lipid profile. However, overall studies indicate there is no real reason to recommend one statin over another. Atorvastatin has the benefit that it can be taken in the morning. The HSE recommends simvastatin as the first choice on State

PCRS schemes for cost reasons; however, all generic statins have become similarly priced in Ireland in recent years with the advent of reference pricing by the HSE.

When should statins be prescribed?

In Ireland, over 20 per cent of adults are at risk of coronary heart disease due to high cholesterol. There is some controversy about who should be prescribed statins. The general guideline for people who have no previous heart problems is that they should be used if cholesterol is high (over 6mmol/l) and there is a cardiovascular risk of greater than 20 per cent over the next 10 years.

Cardiovascular risk over 10 years is the risk of having any cardiovascular event such as stroke or heart attack over the next 10 years. It depends on many factors such as age, sex, weight, blood pressure, cholesterol, family history of heart disease, smoker, or diabetic.

For those who have already suffered a cardiovascular event such as a stroke,

statins are recommended if total cholesterol is over 3.5mmol/l. Guidelines state that they should be considered in all diabetic patients over 40. Statins are very frequently prescribed in the elderly, as elderly patients generally have a higher risk of heart disease.

Side-effects of statins

Like all medication, statins can cause side-effects. The most serious side-effect of statins is a muscle complaint called myalgia. It is characterised by muscle pain and weakness. If it occurs, the statin should be stopped as it can lead to a potentially fatal condition called rhabdomyolysis. It is estimated that one in 1,000 people using statins may suffer from myalgia and onein-10,000 may suffer from rhabdomyolysis. Patients must report to their doctor immediately if they are suffering from muscle pain, tenderness, or weakness while taking a statin. The myalgia from statins is reversible if the statin is stopped promptly.

Statins can also raise liver enzymes,

Table 2: LDL-C concentrations above which PCSK9s are recommended by NICE:

which can lead to liver problems. A liver function test is very important for those starting statins. Current guidelines are to get a liver function test before starting a statin, three months after starting, and again after 12 months.

Gastrointestinal effects (nausea, indigestion, constipation, diarrhoea, and flatulence) are the most common side-effects of statins. Headache, dizziness, and rash occur less frequently. Sleep disturbance can occur, although it seems to be more of a problem with simvastatin and atorvastatin. Most people who take statins have no problems and they are proven to save lives by preventing heart disease.

Can co-enzyme Q10 reduce muscle problems from statins?

Statins can reduce naturally occurring coenzyme Q10 in the body. Co-enzyme Q10 has a role in muscle cell energy production, so some studies have proposed that a co-enzyme Q10 supplement could reduce risk of muscle-related side effects. However, scientific studies to determine how effective coenzyme Q10 is in reducing statin-related muscle pain have mixed results. Some studies show a benefit, while other studies show no effect. So, as coenzyme Q10 rarely has any side-effects, a trial to determine if it helps any potential muscle problems will do no harm.

Non-statin cholesterol medication

Statins are less effective than fibrates in reducing triglycerides. Fibrates – for example, gemfibrozil (Lopid) – are another type of cholesterol-lowering medication but are rarely used nowadays mainly due to gastrointestinal side-effects such as nausea.

Other non-statin drugs used to lower cholesterol include ezetimibe, which reduces the absorption of cholesterol and is used instead of a statin if a statin is not tolerated, or in addition to a statin if a statin is not reducing cholesterol sufficiently.

Ezetimibe

Ezetimibe can be a valuable adjunct in cholesterol management. Ezetimibe is a cholesterol absorption inhibitor that selectively blocks the Niemann-Pick C1Like 1 (NPC1L1) transporter in the small intestine, reducing intestinal absorption of dietary and biliary cholesterol. It offers a useful alternative or adjunct to statins for managing hypercholesterolaemia, particularly when stains are insufficient or not tolerated.

According to NICE UK guidance (NG238), ezetimibe monotherapy is appropriate for adults with primary hypercholesterolaemia (including familial heterozygous hypercholesterolaemia) who are statin-intolerant or for whom statins are contraindicated. It is also recommended as an add-on therapy when maximal tolerated statin doses do not achieve target lipid levels.

Ezetimibe can lower LDL-C by approximately 18-to-25 per cent, and in combination with statins, offers an additive effect without significantly increasing the risk of adverse reactions.

Compared to statins, ezetimibe does not impact liver enzymes or cause myalgia as frequently, making it a gentler option for sensitive patients. The side effects are usually mild and may include abdominal pain, diarrhoea, fatigue, or myalgia. It does not significantly affect HDL-C or triglycerides.

Nilemdo® and Nustendi® LDL-C reduction: Expanding lipid management options in high-risk patients

Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) offer new oral options LDL-C reduction, especially valuable for specific patient subgroups.

LDL-C (Low-density lipoprotein cholesterol) is often called 'bad cholesterol'. It transports cholesterol to arteries, where it can build up, increasing risk of heart disease, stroke, and atherosclerosis.

What Are Nilemdo and Nustendi?

Nilemdo is a once-daily oral lipid-lower-

ing agent containing 180mg of bempedoic acid, while Nustendi is a fixed-dose combination tablet containing 180mg of bempedoic acid plus 10mg of ezetimibe. Both are indicated as adjuncts to diet and maximally tolerated statin therapy, or as monotherapy in statin-intolerant patients, for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia, and to reduce cardiovascular risk in adults with established or high-risk atherosclerotic cardiovascular disease.

Clinical effectiveness

The combination of bempedoic acid and ezetimibe (Nustendi) demonstrated a 36.2 per cent LDL-C reduction compared to placebo in patients already on maximally tolerated statins, outperforming ezetimibe monotherapy (23.2 per cent) and bempedoic acid alone (17.2 per cent). These effects were maintained across diverse subgroups, including those with diabetes and moderate renal impairment.

Beyond LDL-C, the CLEAR Outcomes trial, a landmark 13,970-patient study, demonstrated a 13 per cent relative reduction in MACE-4 events (CV death, non-fatal MI, non-fatal stroke, or revascularisation), driven notably by a 27 per cent reduction in non-fatal MI and 19 per cent reduction in revascularisation procedures (Procedures to restore blood flow in blocked or narrowed arteries, like stents). The LDL-C reduction observed in this study was approximately -20% in six months.

Mechanism and muscle safety

Bempedoic acid inhibits ATP citrate lyase, an enzyme upstream of HMG-CoA reductase in the cholesterol biosynthesis pathway but is activated only in the liver (not in skeletal muscle), reducing the risk of myopathy associated with statins. This makes it particularly attractive for patients who are statin-intolerant or at risk of adverse muscular effects.

NICE guidance

In the UK, NICE recommends bempedoic acid (alone or with ezetimibe) for

patients with primary hypercholesterolaemia or mixed dyslipidaemia, when LDL-C remains above target despite statins and ezetimibe, or where statins are not tolerated. Notably, use must be within a specified risk-based LDL-C threshold and is recommended under specialist or primary care initiation with shared care arrangements.

Reimbursement status in Ireland

In Ireland, both Nilemdo and Nustendi are available under the GMS (medical card) scheme and the Drugs Payment Scheme (DPS). They are classified as prescription-only medicines (POM). In Ireland, GPs can prescribe Nilemdo and Nustendi, especially for statin-intolerant patients; however, initiation often follows cardiology or lipid specialist recommendation, ie, cardiologist recommendation.

Side-effects and monitoring

The most common adverse effects of bempedoic acid include:

f Hyperuricaemia (4.7 per cent) – due to OAT2 inhibition, can precipitate gout.

f Anaemia and decreased haemoglobin.

f Liver enzyme elevations (ALT/AST >3× ULN in up to 2.4 per cent with Nustendi).

f GI symptoms: constipation, flatulence, nausea.

There is also a potential increase in serum creatinine and blood urea nitrogen, though these typically stabilise and reverse post-treatment. Co-administration with simvastatin doses >40mg is contraindicated, and caution is advised with ciclosporin and anticoagulants due to interaction potential.

When to consider?

Bempedoic acid, either alone (Nilemdo) or in combination with ezetimibe (Nustendi), may be particularly suitable in:

f Statin-intolerant patients who cannot reach LDL-C targets on ezetimibe alone.

f Patients on maximally tolerated statins with suboptimal LDL-C levels.

f Those preferring oral therapy over

injectables (ie, PCSK9 inhibitors).

The formulation is not approved for use in children, during pregnancy or breastfeeding, and should be avoided in moderate to severe hepatic impairment.

Why are they a welcome addition to the lipid-lowering toolkit?

Nilemdo and Nustendi represent useful additions to the lipid-lowering toolkit, offering solid LDL-C reductions, oral convenience, and a good safety profile, particularly for those who cannot tolerate statins. While not a substitute for statins or PCSK9 inhibitors in all cases, they serve as important adjuncts or alternatives in patients where traditional therapies fall short. With evidence supporting not just lipid-lowering but also cardiovascular event reduction, their role in cardiology is set to grow.

PCSK9 inhibitors

PCSK9 inhibitors are a new class of cholesterol-lowering drugs that are showing excellent results in bringing down non-HDL levels in certain highrisk patients. They work by blocking a protein called PCSK9, which has a role in moderating cholesterol levels in the blood.

In June 2016, NICE recommended two PCSK9 inhibitor drugs for the NHS – Repatha (evolocumab) and Praluent (alirocumab) – for treating certain patients with primary hypercholesterolaemia or mixed dyslipidaemia who cannot tolerate statins or who have reached the maximum statin dose without sufficient cholesterol reduction.

Researchers on the FOURIER trial investigating the effectiveness of evolocumab in the UK described it as “probably the most important trial result of a cholesterol-lowering drug in over 20 years”. Results showed a 59 per cent drop in cholesterol levels compared to placebo and a 15 per cent lower risk of cardiovascular events.

According to NICE, additional lipid-lowering therapies should be considered:

1. If target LDL-C level is not attained on statins alone, add ezetimibe and trial for at least three months.

2. If target LDL-C level is still not attained, consider PCSK9 inhibitor, subject to NICE criteria in Table 1 , in addition to existing lipid-lowering therapy.

PCSK9 inhibitors in Ireland

Repatha (evolocumab) and Praluent (alirocumab) are both licensed in Ireland. Repatha (evolocumab), for example, is a 140mg solution for injection in Sureclick pre-filled pen and has been available under the High Tech Scheme in Ireland from 1 July 2019. Specific criteria must be satisfied for a patient to be recommended for reimbursement of Repatha under the High Tech Arrangement. The prescribing of Repatha under the High Tech Scheme is confined to designated clinicians who have agreed to the terms of the HSE Managed Access Protocol and have been approved by the HSE Medicines Management Programme. The clinician must submit an online application for individual reimbursement approval for each patient. Applications for individual reimbursement approval will only be considered from approved clinicians. Pharmacists like myself have noticed that a small number of high-risk patients with very stubbornly high cholesterol have been prescribed PCSK9 inhibitors in the last few years under the High Tech Scheme. ●

References: Available upon request

Disclaimer: Brands mentioned in this article are meant as examples only and not meant as preference to other brands.

Author: Eamonn Brady MPSI (Pharmacist). Whelehans Pharmacies, 38 Pearse St and Clonmore, Mullingar. Tel 04493 34591 (Pearse St) or 04493 10266 (Clonmore). www.whelehans.ie. Eamonn specialises in the supply of medicines and training needs of nursing homes throughout Ireland. Email ebrady@whelehans.ie

Considerations in dental health

Many oral health issues can be effectively dealt with in the pharmacy, writes Eamonn Brady MPSI

It is recommended to have a check-up and cleaning with the dentist and dental hygienist every six months. Some people, depending on their specific oral health needs, may require a dental visit more frequently. However, many people visit their dentist less often for many reasons, including financial constraints, lack of time, and fear of the dentist. When people with dental problems visit a pharmacy, the pharmacist is in an ideal position to encourage them

to visit their dentist every six months, as prevention is better than cure. Here are some of the more common dental issues that pharmacists encounter in their practice.

Gingivitis (gum disease)

Gingivitis is more commonly called gum disease (also known as periodontal disease) and is caused by a build-up of bacteria in the gums. It causes gum irritation, red swollen gums, and bleeding.

Gingivitis can be mild, with many not aware they have the condition and only getting treatment when it is too late; ie, when gum and dental damage are evident. Gingivitis is generally not painful but if not treated early, it will result in more serious gum disease (periodontitis), which can cause tooth loss. Gum problems can begin in adolescent years and continue into adulthood.

Periodontitis and general poor oral health can have a detrimental effect on overall health. Periodontal disease

is associated with more risk of heart attack, stroke, and lung disease. In women, it is linked to premature birth or low birth weight babies. It is not fully understood if periodontal disease is a cause of any of these conditions or why people with periodontal disease have higher incidences of these health problems.

Poor oral hygiene is the main cause of gingivitis, as it increases formation of plaque. Plaque, a ‘furry’ coating – that is colourless or sometimes a pale-yellow colour – is a sticky film of bacteria that forms on teeth due

Dry mouth can vary from being a slight nuisance to having a major effect on general health and dental health

to starches and sugars reacting with bacteria found in the mouth. Plaque requires removal daily, via brushing and flossing, as it reforms quickly again within 24 hours after its last removal. If not removed, the bacteria in plaque forms acid, which damages enamel and causes tooth decay and when plaque develops under the gums on the tooth’s root, it can lead to bone damage and eventual tooth-loosening and loss.

While poor oral hygiene is the most common cause of gingivitis, other factors that increase the risk include smoking, being diabetic, increasing age, dry mouth, hormonal changes (due to pregnancy, menstrual cycle, or taking the contraceptive pill), poor diet, substance misuse (ie, alcohol or illegal drugs), and poorly-fitting dentures.

Symptoms

Healthy gums will be firm and a pale pink colour. Signs of gingivitis include

soft, puffy, tender, dark red and easy bleeding gums (may be red or pink colour on the toothbrush or floss). Other signs include swollen gums, receding gums, and bad breath.

A dental appointment is important if some of these symptoms are noticed, as a dentist can quickly diagnose gingivitis and advise on the best course of action. Prompt treatment will clear gingivitis symptoms and prevent development of more serious gum disease and tooth loss. Treatment requires professional care with the dentist followed by improved regular oral hygiene practice at home.

What a dentist will do

After checking teeth, the dentist – or dental hygienist – will do a thorough cleaning to remove all plaque and tartar. Dentists remove plaque and tartar using a procedure called scaling. Scaling may be temporarily uncomfortable, especially as gums are sensitive (which is often the case with gingivitis) or if there is excessive plaque and tartar build-up. Bridges, fillings, teeth that are misaligned, and crowns that are poorly fitting can all irritate gums and prevent the removal of plaque by flossing and brushing in certain areas, so the dentist may need to fix some of these issues. The dentist will advise on effective brushing and flossing techniques at home.

Self-help

Gingivitis will clear up with a thorough professional cleaning by a dentist or hygienist and if the person then practices good oral hygiene by brushing and flossing. There are steps a person can take to prevent and reverse gingivitis, which include: Regular professional dental cleanings every six months; use a soft rather than hard toothbrush and replace it every three or four months; consider using an electric toothbrush as it may be better for removal plaque and tartar. It is important to brush teeth twice daily or better again, after every meal or snack. Floss at least once

daily (this is where many people fail, and it is very important). Use an antiseptic mouthwash if a dentist advises. A thorough cleaning using a toothbrush and floss will take three-to-five minutes if done properly.

Dry mouth

Dry mouth – medically known as xerostomia – is due to a reduction in the saliva produced by salivary glands. Dry mouth is often a side-effect of medication and, less frequently, can also be caused by a condition that damages or blocks salivary glands. Dry mouth can vary from being a slight nuisance to having a major effect on general health and dental health. It affects appetite and taste, hence reducing the enjoyment of food and hence impacting nutrition. Saliva also helps prevent tooth decay by neutralising acids caused by bacteria, preventing growth of bacteria, and washing away food pieces.

Causes

Medicines

Many medicines, including over-thecounter medicines, can cause dry mouth. Medicines with an anticholinergic effect are a common culprit. These include tricyclic antidepressants and older antipsychotic drugs, drugs used for neuropathy (ie, Gabapentin), benzodiazepines, some antihistamines (especially the ones that cause drowsiness), decongestants, analgesics, and muscle relaxants.

Ageing

The ageing process in of itself does not cause dry mouth, but older people are more likely to have conditions that can cause dry mouth and are also more likely to be taking medicines that cause dry mouth.

Cancer treatment

Both chemotherapy and radiation therapy change the quality of saliva and can reduce the amount and quality

of saliva produced. Radiation treatment of the head and neck area is especially known to damage salivary glands and reduce saliva. This may be reversible after treatment but in some cases, it may cause permanent damage and ongoing dry mouth.

Nerve damage

A head or neck injury or surgery that results in nerve damage to the head or neck can lead to dry mouth.

Other health conditions

Dry mouth can be a result of some health conditions, including Sjogren’s syndrome (an autoimmune disease which is a relation of arthritis and causes enlarged salivary glands, dry mouth, and dry eyes) and HIV/AIDS. Stroke and Alzheimer’s disease can make a person perceive they have dry mouth despite normal functioning of the salivary glands. Snoring and breathing with an open mouth (while sleeping) can also contribute to dry mouth.

Smoking

Smoking can cause and exacerbate symptoms of dry mouth.

Symptoms

While dry mouth is a nuisance, it is the symptoms and problems caused by dry mouth that impacts on people’s lives. When not enough saliva is being produced, it can lead to problems that include: Dryness of the mouth or throat; thick and stringy saliva; bad breath; changed taste sensations (or inability to taste flavours properly); problems with chewing; swallowing and speech problems; increased tooth decay, gum irritation, and gum disease; and problems wearing dentures, including friction and pain.

Reduced saliva also leads to more oral problems, including increased plaque, tooth decay, gum disease, mouth sores, fungal infection (candida) in the mouth, coated (discoloured) tongue, cracked lips, and sores or skin splits occurring at the corners of the

mouth. All these problems can lead to poor nutrition due to chewing and swallowing difficulties.

Treatment

Input can be from a doctor, dentist, or pharmacist to advise on the condition. Initially an examination of the mouth, review of medical history, and details of medication being taken, including over-the-counter (OTC) medicines, will be required to rule out and determine possible causes.

Depending on the causes of dry mouth, a GP may need to change medicines that can cause dry mouth. In most cases there are alternative options that will not cause dry mouth. In some cases, it may not be possible

Dry mouth can be a result of some health conditions, including Sjogren’s syndrome and HIV/AIDS

to change the medicines causing the dry mouth, as there may not be suitable alternatives and the benefits may outweigh the risks.

Mouth moisturising products

Options include mouth rinses, artificial saliva, and moisturisers that lubricate the mouth. For severe dry mouth, options include prescription medication that works by stimulating saliva. Options include pilocarpine or cevimeline that stimulates saliva production. There are OTC saliva substitutes available from pharmacies, including the Bioxtra and Biotene range of products. These brands – available as gels, mouthwashes, toothpaste, and chewing gums – have been shown in studies to increase saliva flow by up to 200 per cent and shown to relieve pain

associated with dry mouth and improve taste and flavours. These products stimulate saliva flow, as well as lubricate the mouth.

Other tips

Sip water or sugar-free drinks regularly to moisten mouth and drink water during meals, as it will help make chewing and swallowing easier. Use sugar-free chewing gum or suck sugar-free hard sweets. Bear in mind however that xylitol is often a sugar substitute in sugar-free products, and it can bring on diarrhoea and cramps if taken in large amounts. Aim to breathe through the nose, not the mouth. Treatment for snoring may be recommended, as snoring causes breathing through the mouth during the night. A room humidifier may also help, as it will add moisture to the air while sleeping. Regular moisturisation of the lips will soothe dry or cracked areas. Because of increased risk of dental problems, regular check-ups with a dentist are recommended.

What to avoid?

Avoid substances that can exacerbate dry mouth, including caffeine and alcohol; avoid mouthwashes containing alcohol; avoid salty and dry food; stop smoking; and discuss with your GP or pharmacist medicines to avoid, including OTC medicines, that can cause dry mouth, such as antihistamines and decongestants.

Mouth ulcers

Also known as aphthous ulcers, mouth ulcers are painful, clearly defined, round, or oval sores which form in the mouth. Most people suffer from occasional mouth ulcers, but one-in-five people suffer from recurrent mouth ulcers. The three main types of mouth ulcer are: Minor ulcer : This is the most common type of ulcer. It accounts for 80 per cent of all mouth ulcers. They are small (2-8mm in diameter) and normally heal naturally within 10-14 days. A minor ulcer will not cause any scarring. Major ulcer : This type of ulcer is

deeper and larger than a minor ulcer and usually has a raised or irregular border. A major ulcer is usually 1cm or more in diameter. This type of ulcer will heal more slowly, over a period of several weeks, and can cause scarring. Approximately 10 per cent of mouth ulcers are major.

Herpetiform ulcers : These ulcers form as multiple, pinhead-sized sores. The number of ulcers can range from 5-100. These tiny ulcers often fuse together to form larger, irregular shaped sores which are extremely painful. Approximately 5-10 per cent of mouth ulcers are herpetiform.

Mouth ulcers cannot be passed from person-to-person. For example, a person cannot get an ulcer from kissing someone, or from sharing a glass or cutlery.

Most mouth ulcers will only last between 10-to-14 days, although in more severe cases, they may last for several weeks

Symptoms

A mouth ulcer will be round or oval. It will be white, yellow, or grey in colour, and will be inflamed around the edge. Most mouth ulcers will only last between 10-to-14 days, although in more severe cases, they may last for several weeks.

Causes

Most minor, single mouth ulcers are caused by damage to the mouth. For example, accidentally biting the inside of the cheek while eating or burning the inside of the mouth with hot food. Damage to the mouth can also occur if a toothbrush is used incorrectly, or from a sharp tooth or filling.

Recurrent mouth ulcers

The cause of recurrent mouth ulcers is often unknown. Potential causes include:

1. Oral trauma – ie, excessive tooth brushing, or chewing sharp, or hard, foods.

2. Anxiety.

3. Stress.

4. Certain foods – some people may find that eating certain foods can cause them to develop more ulcers. Foods that have been identified as increasing the risk of ulcers include chocolate, coffee, peanuts, almonds, strawberries, cheese, tomatoes, and wheat flour.

5. Hormonal changes – women notice that they are more likely to have an ulcer during their period due to hormonal changes.

6. Smoking cessation – may cause a temporary increase in ulcers.

7. Family history – ulcers can run in families.

8. Underlying condition – certain conditions can cause ulcers, including low vitamin B12 , iron deficiency, coeliac disease , Crohn’s disease, and immunodeficiency.

9. Medication – some prescription medication can cause mouth ulcers. Examples include non-steroidal antiinflammatory drugs, nicorandil, and beta-blockers.

Treatment

Mouth ulcers will normally heal naturally without the need for treatment. However, if an ulcer lasts for more than three weeks, the patient should get checked at a GP, as it may be due to a more serious condition. Some of the treatment options available OTC or on prescription are listed below.

Corticosteroids

These should only be prescribed in more severe cases. A corticosteroid will reduce the inflammation of the ulcer, making it less painful. A GP may prescribe soluble prednisolone for the patient to use as a mouthwash in severe cases.

Antimicrobial mouthwash

Antimicrobial mouthwash helps to kill any micro-organisms, such as bacteria, viruses, or fungi that may cause a mouth infection if the patient cannot brush their teeth properly.

Analgesics

There are many OTC remedies available in pharmacies.

When to refer?

Refer to a GP or dentist if a mouth ulcer lasts more than two-to-three weeks, particularly if it does not appear to be like my description in this article or shows no sign of healing or going. This is because other types of ulcers can occur in the mouth and mouth cancer may at first seem like a mouth ulcer.

Prevention

To prevent getting mouth ulcers, try to avoid becoming run-down by eating a balanced diet, take regular exercise, and learn to effectively manage stress. If prone to recurrent ulcers, try to avoid damaging the inside of the mouth by using a softer toothbrush and avoiding hard, brittle, or sharp-edged foods. Make sure your teeth are in good order by regularly visiting a dentist. Flossing regularly reduces bacteria in the mouth.

Halitosis (bad breath)

Up to 50 per cent (22 to 50 per cent) of the population suffer from bad breath, and about half of these experience a severe problem leading to personal and social discomfort and social embarrassment. The ‘mouth air’ of those suffering from more severe halitosis is tainted with compounds including hydrogen sulphide, methyl mercaptan, and organic acids leading to foul-smelling air.

Aetiology

The source of the bad odour is located within the oral cavity in approximately 90 per cent of cases of halitosis, meaning only a small percentage of cases are due to non-oral causes

such as a serious underlying medical condition, which warrants immediate referral to a doctor, ie, diabetes.

The biggest source of bad breath is the tongue, which is the main cause in up to 90 per cent of cases, say experts. Other causes like gingivitis are considered a cause in only a fraction of causes compared to tongue hygiene.

Oral micro-organisms most likely to cause halitosis are gram-negative bacteria species, which includes treponema denticola, porphyromonas gingivalis, prevotella intermedia, bacteroides loescheii, enterobacteriaceae, centipeda periodontii, and fusobacterium nucleatum (this oral bacteria list is not exhaustive).

Common causes

f Failing to brush teeth twice daily.

f Improper cleaning of dentures.

f Bad breath in the morning. This affects most people, and dry mouth is the most common cause.

f Alcohol causes dehydration and less saliva production, leading to bad breath.

f Smoking, often called 'smokers’ breath', which is a stale scent caused by the scent of cigarette smoke lingering in the mouth and the chemicals from cigarette smoke mixing with saliva.

f Certain foods and drinks such as onion, garlic, coffee, and acidic fizzy drinks

f Infection (more below).

More specific causes

Tongue bacteria : Considered one of the main causes of bad breath. It can be caused by catarrh from the back of the throat and nasal area. It is more often caused by a general build-up of oral bacteria due to poor dental hygiene. Brushing the tongue with toothpaste (especially if coated) can help. A tongue scraper or cleaner may be used in more severe tongue coating. Despite the tongue being considered the biggest factor in halitosis, simple general oral hygiene measures such as regular teeth brushing, flossing, and staying

well hydrated will minimise build-up of bacteria in all areas of the mouth, including the tongue (not just the gums and teeth).

f Gum disease (gingivitis): Due to poor oral hygiene. Bacteria in plaque cause a bad odour.

f Tooth decay: Like the bacteria that causes food to break down (creating plaque) and causing gingivitis, the bacteria trapped in a decaying tooth can emit a foul smell.

f Trapped food: Food getting caught between the teeth getting broken down by bacteria.

f Dry mouth: Poor saliva flow means food debris is less likely to get washed away. Described above.

f Acid reflux from the stomach:

Specific diagnostic tools are only used in rare cases in which halitosis remains severe and persistent

These acids have a sour odour, causing bad breath

f Diabetes: Diabetics are more prone to high blood sugar levels, meaning higher glucose levels in saliva, which promotes oral bacteria growth (glucose is a food source for bacteria), leading to more dental plaque. Well-controlled diabetes and good oral hygiene reduce this risk in diabetes.

f Chest infection: Phlegm or mucus infected with bacteria or viruses that can have a smell.

f Other infections: In tonsil, throat, and sinus infections the bacteria/viruses involved can emit a foul smell.

f Other chronic conditions : Certain lung conditions, kidney and liver disease, chronic irritation of the stomach and oesophagus, and autoimmune disorders like Sjogren’s

syndrome can cause halitosis.

Diagnosis in severe cases

It is rare that someone must get diagnosed with halitosis, as they will be aware of it themselves or those close to them will make them aware of it and the steps described in this article will ease symptoms in most cases. Specific diagnosis tools are only used in rare cases in which halitosis remains severe and persistent, despite the person already taking simple steps to improve their dental hygiene and diet.

In this situation, three methods for measuring halitosis are:

Organoleptic measurement.

Gas chromatography.

Sulphide monitoring.

Organoleptic measurement has shortcomings but is nonetheless the gold standard method to assess severe halitosis.

Interventions to stop bad breath

Improving oral hygiene is the number one step to improving bad breath. Some of the other interventions described below – in addition to the usual oral hygiene interventions like regular brushing and flossing – may be considered if bad breath persists despite good oral hygiene.

f Regular brushing : Brushing teeth morning and night with fluoride and antimicrobial toothpaste. Do not rinse the mouth out with water straight away after brushing, as this will rinse away the fluoride and antimicrobial benefits.

f Dental flossing: Should be done daily using the proper technique.

f Regular dental check-ups : A dental check-up with dentist once a year and cleaning with dental hygienist every six months.

f Dental mouthwash daily: There are also specific brands of mouthwashes on the market specifically designed to tackle bad breath. The gold standard was traditionally chlorhexidine but there are many others with other ingredients that work by reducing

volatile sulphide compounds (VSC). Side-effects of mouthwashes may include staining of teeth (more in the case of chlorhexidine), a burning sensation, and changing sense of taste.

f Balanced diet: Eating a healthy balanced diet limiting sugary foods and drinks.

f Drinking water : Regularly drinking throughout the day. An average of two litres per day for adults is advised.

f Chewing sugar-free gum . Chewing gum loosens food and dead cells from teeth, gums, tongue, and promotes saliva production. Sugar-free gum sweetened with xylitol is very effective for easing bad breath because xylitol inhibits mouth bacteria. To get the full benefit of chewing xylitol-sweetened gum, aim to chew it for at least five minutes after meals.

f Probiotics: This is less proven, but some research in Japan found that consuming sugar-free yogurt with probiotic bacteria twice a day for six weeks reduced bad breath by reducing the levels of odour-producing sulphide compounds. One Japanese study found that eating yogurt with the probiotic strains of streptococci and lactobacilli bacteria has the best effect.

f Avoid crash diets: Apart from the many other negative effects of crash diets, a low-carbohydrate diet breaks fat into ketones to create ketosis. These ketones accumulate in urine and saliva and can cause bad breath. The effect of ketones in the mouth is a metallic taste in the mouth and a smell that is described as sweet, fruity, or like the smell of nail polish remover. Drinking plenty of water will dilute the concentration of ketones, thus reducing bad breath from ketones.

Dental flossing

Proper dental flossing removes plaque and food particles from areas where a toothbrush cannot reach including under the gum-line and between teeth. Plaque build-up can lead to tooth decay and gum disease. As brushing alone will not remove all plaque, daily flossing is highly recommended.

How to floss?

To ensure one gets to all areas that are inaccessible by toothbrush and to ensure the gums are not damaged by poor flossing technique, it is important to use the correct technique. Start with approximately 15 inches of floss. Wind most of the floss around each middle finger allowing about two inches of floss to floss with. Grip the floss firmly between the thumbs and index fingers; glide it very gently up and down between the teeth. It is important to curve the floss gently around the base of each tooth and ensuring the floss goes beneath the gum-line to where more food can be trapped. Do not use a 'sawing' motion as this will cut into the gums and damage the gums and cause bleeding. Likewise, do not snap or force the floss as this will also damage the gums. It is best practice to use clean sections of floss when moving from tooth-to-tooth. To remove floss, use the same gentle back and forth movement to glide the floss out and away from each tooth base.

What type of floss to use?

To be very general, there are two main types of floss, a flat ‘tape-like’ floss and a round floss which is thinner and more like a thread. The ‘tape’ floss is designed to increase contact area with the tooth.

It is best practice to use clean sections of floss when moving from tooth-to-tooth. To remove floss, use the same gentle back and forth movement to glide the floss out and away from each tooth base

There are other slight differences between different flosses, including differences in the material they are made from (nylon or polytetrafluoroethylene), whether they are waxed or unwaxed (waxed is meant to slide easier between teeth), if they have different flavours, or are with or without fluoride etc. However, these subtle differences do not make too much of a difference.

The most important thing is to floss at least once daily and to use the correct technique to remove plaque and debris between teeth. After that, it is up to individual preference which brand and type to use.

More about flossing

A thorough cleaning with a toothbrush and floss should take only three-to-five minutes. Flossing before brushing is important as it clears food particles and bacteria between teeth that a toothbrush cannot reach. It is reckoned that 80 per cent of people do not floss. Brushing only reaches 65 per cent of the surface area of teeth – flossing is needed to reach the other 35 per cent. If someone has never flossed before, teeth may bleed slightly during the first few times, however, this bleeding will stop after a few times as gums get used to flossing. The patient should ask their dentist or hygienist how to floss properly. If a patient has never flossed before, they should see their gums turn a healthier pink colour within a few weeks of starting. ●

References upon request

Disclaimer: Brands mentioned are meant as examples only and not meant as preference to other brands.

Author: Eamonn Brady MPSI (Pharmacist). Whelehans Pharmacies, 38 Pearse St and Clonmore, Mullingar. Tel 04493 34591 (Pearse St) or 04493 10266 (Clonmore) W. www.whelehans.ie Eamonn specialises in the supply of medicines and training needs of nursing homes throughout Ireland. Email ebrady@whelehans.ie.

European Commission approves two new indications of TREMFYA (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction, for the treatment of inflammatory bowel disease

 TREMFYA is the first and only fullyhuman, dual-acting IL-23p19 subunit inhibitor approved in both ulcerative colitis and Crohn’s disease.

 The approval expands the treatment portfolio available to people living with inflammatory bowel disease in Ireland.

Johnson & Johnson Innovative Medicine recently announced that the European Commission (EC) has approved a Marketing Authorisation (MA) for two new indications of TREMFYA (guselkumab), for the treatment of two types of inflammatory bowel disease (IBD). Following two separate MA announcements in April and May, guselkumab is now approved for the treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s disease, who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. Guselkumab is now the first dual-acting IL23 inhibitor offering both intravenous (IV) and subcutaneous (SC) induction options.    Crohn’s disease and ulcerative colitis are the two main forms of IBD, which are chronic gastrointestinal conditions affecting an estimated 40,000 people in Ireland. These diseases can present at any

age but are most commonly diagnosed in young adults between 15 and 35 years, with a second peak incidence observed between 50 and 60 years of age. Symptoms such as diarrhoea, abdominal pain, fatigue, and weight loss often lead to significant impairment in daily functioning and quality of life.

Professor Aoibhlinn O’Toole, Consultant Gastroenterologist at Beaumont Hospital, said: “These approvals mark a welcome development in how we care for people with Crohn’s disease and ulcerative colitis. Having additional treatment options supported by strong clinical and endoscopic data allow us to better tailor therapy to each patient’s needs, with the goal of achieving sustained remission and improving long-term quality of life. Guselkumab has demonstrated robust rates of endoscopic remission with both IV and SC induction options, giving patients and physicians more flexibility.”

Michaela Hagenhofer, General Manager, Commercial Operations at Johnson & Johnson Innovative Medicine, said: “These MA decisions represent an important step forward for people living with IBD, who often face lifelong challenges in managing their condition. Our focus has always

been on driving science that makes a real difference in patients’ lives. With these approvals, we are broadening the tools available to clinicians and supporting more tailored, effective care for those impacted by Crohn’s disease and ulcerative colitis.”

The CD approval is supported by results from the Phase 3 GALAXI and GRAVITI programmes in moderately to severely active CD, in adults who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. Data from the pooled Phase 3 GALAXI 2 and 3 studies, which evaluated guselkumab IV induction and SC maintenance therapy, showed that guselkumab demonstrated greater efficacy compared to ustekinumab in endoscopic response and endoscopic remission at Week 48, the only IL-23 inhibitor to achieve this in a doubleblinded registrational programme. The GRAVITI study evaluated guselkumab SC induction and maintenance therapy versus placebo following 12 weeks of induction and at 48 weeks of maintenance therapy. The results from these Phase 3 studies demonstrated the efficacy of IV or SC guselkumab in achieving clinical and endoscopic endpoints.

Teva launches ticagrelor teva 90 mg film-coated tablets

Teva Pharmaceuticals is pleased to announce the launch of Ticagrelor Teva 90mg Film-coated Tablets.

Ticagrelor Teva co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) or a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.

For any queries or further information, please contact your local Teva representative or contact Teva on 1800 201 700.

Further product information is available upon request or from the SmPC available at hpra.ie.

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

Anam Pharmacy and West Sligo Athletics Club announce new partnership

Anam Pharmacy in Enniscrone is proud to announce a landmark three-year partnership with West Sligo Athletics Club, becoming the club’s first ever main sponsor. This collaboration marks a significant step forward for both organisations and underscores a shared dedication to health, wellbeing, and community spirit in West Sligo.

“We’re thrilled to partner with West Sligo AC,” said Sarah Collins, proprietor of Anam Pharmacy. “As a vibrant and fast-growing club, they represent everything we value — community engagement, youth development, and promoting healthy, active lifestyles. Supporting them is our way of giving back to the community that has shown us so much support since we opened our doors last October. We’re really excited to grow together

Pictured at Anam Pharmacy Enniscrone at the announcement of the new sponsorship were: L-R: Lisa Browne (Anam Pharmacy), Rachel Burke (West Sligo Athletics Club), Sarah Collins (Anam Pharmacy), Louise O'Neill (West Sligo Athletics Club), Sharon Crean (Anam Pharmacy), Keira Harrington (Anam Pharmacy), Martin McHale (West Sligo Athletics Club). Photographer: Denise K, Easkey

over the coming years.”

West Sligo AC, established just three years ago, has already become a cornerstone of the local community in Enniscrone. Welcoming the new partnership, club treasurer Louise O’Neill

said: “This sponsorship is a huge boost for West Sligo AC. It will directly support the club’s growth and day-to-day activities, from equipment to event participation. We are very grateful to Sarah and her

team at Anam Pharmacy for the support.”

Located just off the main street in Enniscrone, Anam Pharmacy is a modern, communityfocused pharmacy offering expert advice, prescription services, health screenings, and personalised care in a welcoming environment.

Led by experienced Pharmacist Sarah Collins, already a familiar face to many through her work as a Pharmacist in Ballina, Anam Pharmacy has quickly become a trusted local health hub.

Two private consultation rooms and a strong focus on patient care make Anam Pharmacy a standout in the community. And with an ever-expanding range of services, Sarah and her team are committed to ensuring the people of West Sligo have easy, local access to the healthcare support they deserve.

Piecing together awareness for haemochromatosis: Over 20,000 people in Ireland living with undiagnosed iron overload

An estimated 20,000 people in Ireland are living with undiagnosed haemochromatosis, commonly known as an ‘iron overload’ condition. Also known as the ‘Celtic Gene’, Ireland has the highest rates of haemochromatosis in the world, with one-in-83 people at risk of developing it and one in

five carrying the gene. Despite its prevalence, haemochromatosis remains one of the least recognised genetic conditions in the country.

Haemochromatosis is a genetic disorder where large amounts of iron are absorbed from the diet into vital organs, in other words ‘iron overload’. Symptoms

of haemochromatosis can range from chronic tiredness and joint pain to abdominal pain, irregular heartbeat and liver problems. Early diagnosis is crucial in ensuring effective management on the condition and preventing serious complications if left untreated, such as organ damage or even premature death.

To mark World Haemochromatosis Awareness Week, which took place from 1 June to 7 June 2025, the Irish Haemochromatosis Association (IHA) amplified the conversation and educated the public on the symptoms to promote early diagnosis of Ireland's most common genetic disorder. The IHA is urging anyone experiencing related symptoms to ‘Get Checked for Haemochromatosis’ to save lives by consulting their GP, who can arrange a simple blood test alongside an iron panel to detect high levels of iron in the blood.

This year, the Irish Haemochromatosis Association has partnered with Meath GAA star and 2023 Tailteann Cup Footballer of the Year, Mathew Costello. Speaking about the awareness drive for World Haemochromatosis Awareness Week, Mathew says:“I know how important it is to stay on top of your health, both on and off the field. That’s why I am honoured to help

raise awareness of the nation’s most common genetic condition in the hope that someday everyone in Ireland will be aware of the symptoms. While it’s not something I’ve personally encountered, the more I learn about it, the more I realise how crucial early detection is. It’s about staying ahead of the game - catching things early can save your life. I’m proud to team up with the IHA this year to spread the word and encourage people to ‘Get Checked for Haemochromatosis’. Health is everything, and we all need to take care of it."

Prof John Ryan, Consultant Hepatologist at Beaumont Hospital, said: "Early diagnosis of haemochromatosis is crucial, as it allows for the prevention of serious complications. When diagnosed early, treatment can effectively manage the condition. The Irish Haemochromatosis Association has played a key role in raising awareness of

First patient in the world treated for muscle-weakness disease in

Ireland's most common genetic condition educating the public on recognising symptoms and seeking timely treatment."

This year will see several City and County Councils throughout the country supporting the campaign and joining the wider, international initiative to ‘Light Up Red’, lighting up several iconic public buildings during World Haemochromatosis Awareness Week. Buildings being illuminated in red will include the Mansion House, Dublin, Dublin Convention Centre, County Hall Swords, Swords Castle, Fingal Town Hall and Casino Model Railway, Swords, Cork City Hall, Cork County Hall, Limerick Council Offices, Sligo City Hall, Donegal Public Services Centre and Kerry County Council Buildings, Tralee, Princes Quay and Ashe Memorial Hall Building, Tralee, Killarney Town Hall and Killorglin Area Services Centre, Co. Kerry.

For more information, please visit www.haemochromatosis.ie.

clinical trial at HonorHealth Research Institute

Myasthenia gravis most often attacks young women and older men, often leaving them unable to properly care for themselves

The first patient enrolled in a planned international clinical trial has been treated at HonorHealth Research Institute with a new type of immune therapy for those with rare muscleweakness disease myasthenia gravis. In an odd medical twist, this autoimmune disease – in which antibodies interfere with the connection between nerves and muscles – most often strikes young women in their 20s and 30s, and older men in their 60s and 70s, though it can affect others.

The disease affects fewer than 200 in one million people. Symptoms range from

droopy eyelids, problems chewing, general fatigue, difficulty swallowing, and even problems breathing when the muscles surrounding the lungs are weakened. Patients often find it difficult to conduct basic hygiene and grooming including things as simple as brushing their teeth, taking a shower, and getting dressed.

Anne Hatch, principal investigator for this international clinical trial, which will consider the safety and effectiveness of drug Remibrutinib, manufactured by Novartis Pharmaceuticals, described the trial as “exciting”.

Dr Hatch explained that, for the first time in this disease, the drug will target B cells, a type of white blood cell that makes antibodies. While usually an important part of the body’s immune system, she said, in myasthenia gravis malfunctioning

white blood cells interfere with the messaging between the nervous system and muscles in what is known as the neuro-muscular-junction pathway.

“This new drug blocks a different part of the pathway than before,” Dr Hatch said. “Hopefully, with this new mechanism of action, the patient’s symptoms will improve.”

If successful, this Phase III clinical trial could lead to the drug being approved for myasthenia gravis by the US Food and Drug Administration. The treatment has already been approved for some types of cancer.

Trial participants must be 18-75 years old with a confirmed diagnosis of myasthenia gravis. They must be able to breathe without a respirator and be able to safely swallow the oral medication.

Effective and safe for the treatment of allergic conjunctivitis1

NEW PACK

Opticrom® Allergy is now available in a fresh new pack at your local pharmacy.

Can provide rapid of symptoms within 2 minutes2,3

Significantly reduces ocular itching, redness and foreign body sensation1

1. Liu YL, Hu FR, Wang IJ, Chen WL, Hou YC. A double-masked study to compare the efficacy and safety of topical cromolyn for the treatment of allergic conjunctivitis. J Formos Med Assoc. 2011;110(11):690-4. 2. Mösges R, Hassan HA, Wenzel MR. Optimal use of topical agents for allergic conjunctivitis. BioDrugs. 1997;8(4):250-64 3. Montan P, Zetterström O, Eliasson E, Strömquist LH. Topical sodium cromoglicate (Opticrom) relieves ongoing symptoms of allergic conjunctivitis within 2 minutes. Allergy. 1994;49(8):637-40. Opticrom Allergy Single Dose 2% w/v eye drops solution Each single dose container contains 2% w/v of sodium cromoglicate. Also contains sodium chloride and purified water. Presentation: Single dose containers containing a clear colourless or pale yellow liquid packaged in an aluminium sachet. Indications: For the relief and treatment of seasonal and perennial allergic conjunctivitis. Dosage: Adults and children: The recommended dose is one or two drops in each eye four times a day. Opticrom Allergy single dose should be used regularly to ensure optimal control of symptoms. It is recommended that treatment is continued during the period of exposure to allergen. Paediatric: In children, caregiver supervision and/or assistance may be required. Method of administration: For ocular use only. It should be administered in the conjunctival sac of the affected eye. To avoid contamination, the tip of the container should not touch the eye or any surface. As with most ophthalmic preparations, contact lenses should be removed before each application and may be inserted after 15 minutes. In case of concomitant treatment with other eye drops, instillations should be 15 minutes apart. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and precautions: Opticrom Allergy single dose is sterile, preservative-free, and presented in a single dose container which should be used immediately after opening and any remaining contents discarded after use. Interactions: No interaction studies have been performed. Fertility, pregnancy and lactation: Pregnancy: As with all medication, caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on foetal development. It should be used in pregnancy only where there is a clear need. Breast-feeding: It is not known whether sodium cromoglicate is excreted in human breast milk but, on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest the use of sodium cromoglicate has any undesirable effects on the baby. Fertility: Animal studies did not show any effect on fertility. It is not known if sodium cromoglicate has an effect on human fertility. Driving and operation of machinery: As with all eye drops, instillation of these eye drops may cause a transient blurring of vision. Patients are advised not to drive or operate machinery if affected, until their normal vision has been re-established. Undesirable effects: Transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported. Local and systemic hypersensitivity reactions have been reported. Adverse events should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Pack size: 20 single dose containers. Marketing authorisation holder: Clonmel Healthcare Ltd. Marketing authorisation number: PA0126/381/003. Medicinal product not subject to medical prescription. Supply through pharmacies only. A copy of the Summary of Product Characteristics is available upon request or alternatively please go to: www.clonmelhealthcare.ie. Last revision date: February 2025. 2025/ADV/OPT/028H