TAKING IT TO THE STREET
Dr Des Corrigan examines the link between veterinary medicines and illicit drugs
CLINICAL CONTENT
CPD MODULE: Migraine
Also clinical content on:
Allergic Rhinitis
Kidney Medications
Rheumatoid Arthritis
A look at the practicalities of the recommendations from the Expert Taskforce
For relief of symptoms of hay fever and other allergic conditions, skin rashes or itchy,
Last month saw the launch of a position paper that emphasised the need for preventive adult immunisation in Ireland, along with all the health benefits that would bring.
The vision for the initiative is "an Ireland where everyone, everywhere, at every age, fully benefits from vaccines for good health and wellbeing".
Previous vaccination strategies have by necessity focused on the younger population, and have brought enormous benefits for that cohort. But as we all know too well, Ireland's population is ageing at a rate never seen before. To quote one of the more blunt statistics, the number of people aged 65 years and over is estimated to have risen by over 40 per cent between 2013 and 2023, from 569,000 to 806,000, and is expected to double again to
1.6 million by the year 2051 (Central Statistics Office).
This is of course going to be a big deal in the years ahead, both for healthcare providers and policy-makers. The paper, titled 'Vision and Strategic Approach to Adult Immunisation in Ireland', is a proactive effort to better prepare for this explosion of the elderly.
Policy-makers are not, of course, heartless brutes. They understand that significant morbidity and mortality occur as a result of preventable diseases. But the authors of the paper realise that economic benefits are also a tasty incentive for funding. A 2024 report by the Office of Health Economics estimated that full implementation of the NIAC recommendations for influenza, pneumococcal disease, herpes zoster and RSV would result in a return of €23 in socioeconomic
benefit for every €1 spent. This equates to approximately €4.8 billion in net monetary benefits. Resourcing will be vital if the vision is to be realised, so this is a crucial point to drive home.
At the launch, it was heartening to see pharmacy, the medical profession, and industry working together. Kathy Maher of the IPU represented pharmacy, while the medical specialties of paediatrics, infectious disease and immunisation were also represented on the panel (see your May issue for a report on the launch).
Attending the event, it was refreshing to see a mix of pharmacists, doctors, nurses and allied professions come together and recognise each other's potential in this area. Encore!
Pat Kelly pat@greenx.ie
04: News
National and international news in pharmacy
16: New territory
A look at the practicalities of the Expert Taskforce recommendations, including the reaction from the medical profession
20: Act now
The EC has proposed a Critical Medicines Act to boost supply
22: Down the drain?
Over €700,000 has been 'needlessly' spent on duplicate communications to healthcare professionals
24: Fintan Moore
Is artificial intelligence our friend, foe, or is it somewhere in between?
26: Dr Des Corrigan
The link between veterinary medicines and the illicit drug trade is an ongoing problem
28: Terry Maguire
There are dark corners down the rabbit hole of mental health research
30: Áine Mac Grory
Technology should be embraced for the PSI Council elections
Earn 2 CPD points with our module on Migraine
41: Allergic rhinitis
A clinical overview of assessment and treatment for the different types of allergic rhinitis
4 6: IBD awareness
Pharmacists are on the front line when it comes to recognising the symptoms of IBD in patients
50: Arthritis
A look at some clinical considerations in treating rheumatoid arthritis, including the importance of a multidisciplinary approach to care
54: Kidney transplants
A clinical overview of current kidney transplant medications and procedures, potential complications, rejection, and what medications to avoid
61 : Motoring
Shane O'Donoghue test-drives
the new MINI Aceman
63: Gallery
Images from the recent IIOP RCSI Parallel Session on 'Next Generation Pharmacy'
64: Gallery
Photos from the launch at the RCPI of a paper titled 'Vision and Strategic Approach to Adult Immunisation in Ireland'
65: Product News
A round-up of product and industry news
Editor
Pat Kelly, pat@greenx.ie
Subeditor
Elaine Walsh
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Laura Kenny laura@greenx.ie
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Daiva Maciunaite, daiva@greenx.ie
Managing Director
Graham Cooke, graham@greenx.ie
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Publisher and Managing Director: Graham Cooke, graham@greenx.ie
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Cover design: Laura Kenny. Imagery used: iStock.com
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Weight loss experienced in 1 out of 3 patients at 68 weeks1,2 *«#†
mean weight loss sustained over 2 years1,3#§
Irish Clinical Practice Guidelines
Wegovy® is proven to treat obesity1,2,3 and reduce the risk of major cardiovascular (CV) events1,4 ¶
relative risk reduction for major CV events, including heart attack and stroke vs placebo1,4 ¶
Cardiology Guideline Update
As recommended by the 2024 ESC Guidelines for the management of chronic coronary syndromes5‡
For weight management, including weight loss and maintenance, in adults with an initial BMI of ≥30 kg/m2, or ≥27 to <30 kg/m2 with ≥1 weight-related comorbidity as an adjunct to a reduced-calorie diet and increased physical activity.1
For weight management in adolescents ≥12 years with obesity (BMI ≥ 95th percentile) and BW >60 kg as an adjunct to a reduced-calorie diet and increased physical activity.1
* Treatment policy estimand (assessed the treatment effects at week 68, regardless of treatment discontinuation or rescue intervention use).
« The primary endpoint in the STEP 8 study was change in body weight (%) from baseline to week 68. 16.7% and 6.7 % mean weight loss reported in the Wegovy® and Liraglutide arms respectively.§
# Adults living with obesity (BMI ≥30 kg/m2), or with overweight (BMI ≥27 to <30 kg/m2) and at least one weight-related comorbidity.
† This was a confirmatory secondary endpoint in STEP 8.
§ Trial product estimand (assessed treatment effect if a trial product was taken as intended).
¶ The primary endpoint in the SELECT clinical trial was the time from randomisation to first occurrence of major adverse cardiovascular events (MACE), defined as a composite endpoint consisting of cardiovascular death (including undetermined cause of death), non-fatal myo-cardial infarction, or non-fatal stroke. ‡ 2024 ESC guidelines to reduce CV mortality, MI, or stroke in chronic coronary syndrome patients with overweight (BMI >27 kg/m2) or obesity and without T2D. BMI, Body Mass Index; CV, Cardiovascular; MACE, Major Adverse Cardiovascular Event; ESC, European Society of Cardiology. T2D, type 2 diabetes.
Abbreviated Prescribing Information
Wegovy®t(semaglutide)
Please refer to the full Summary of Product Characteristics (SmPC) before prescribing. Wegovy® 0.25 mg FlexTouch® solution for injection in pre-filled pen. Wegovy® 0.5 mg FlexTouch® solution for injection in pre-filled pen. Wegovy® 1 mg FlexTouch® solution for injection in pre-filled pen. Wegovy® 1.7 mg FlexTouch® solution for injection in pre-filled pen. Wegovy® 2.4 mg FlexTouch® solution for injection in pre-filled pen. Indication(s): Adults: Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥30 kg/m2 (Obesity) or ≥27 kg/ m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. For trial results with respect to cardiovascular risk reduction, obesity-related heart failure, and populations studied, see section 5.1. of the Wegovy® SmPC. Adolescents: Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with obesity* and body weight above 60 kg. Treatment with Wegovy® should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose. *See table 1 in the Wegovy® SmPC for BMI cut-off points for obesity by sex and age. Posology and administration: Administered once weekly at any time of the day, with or without meals. Injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed. It should not be administered intravenously or intramuscularly. Injection sites should always be rotated to reduce the risk of injection site amyloid deposits. The day of weekly administration can be changed if necessary, as long as the time between two doses is at least 3 days (>72 hours). After selecting a new dosing day, once-weekly dosing should be continued. Adults: The maintenance dose of semaglutide 2.4 mg once-weekly is reached by starting with a dose of 0.25 mg. To reduce the likelihood of gastrointestinal symptoms, the dose should be escalated over a 16-week period to the maintenance dose. In case of significant gastrointestinal symptoms, consider delaying dose escalation or lowering to the previous dose until symptoms have improved. Adolescents: For adolescents ages 12 years and above, the same dose escalation schedule as for adults should be applied. The dose should be increased until 2.4 mg (maintenance dose) or maximum tolerated dose has been reached. Weekly doses higher than 2.4 mg are not recommended in the adult and adolescent populations. Patients with type 2 diabetes: When initiating Wegovy®, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia. Missed dose: If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped, and the next dose should be administered on the regularly scheduled day. If more doses are missed, reducing the starting dose for re-initiation should be considered. Elderly: No dose adjustment is required based on age. Renal impairment: No dose adjustment is required for patients with mild or moderate renal impairment. Experience in patients with severe renal impairment is limited. Semaglutide is not recommended for use in patients with severe renal impairment (eGFR <30 mL/min/1.73m2) including patients with end-stage renal disease. Hepatic impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment. Experience in patients with severe hepatic impairment is limited. Semaglutide is not recommended for use in patients with severe hepatic impairment and should be used cautiously in patients with mild or moderate hepatic impairment. Paediatrics: The safety and efficacy of semaglutide in children below 12 years of age have not been established. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation. Therefore, the increased risk of residual gastric content due to delayed gastric emptying should be considered prior to performing procedures with general anaesthesia or deep sedation. Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions that can cause dehydration, which in rare cases can lead to a deterioration of renal function. Patients should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Wegovy® should be discontinued; if confirmed, Wegovy® should not be restarted. Caution should be exercised in patients with a history of pancreatitis. In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis. Wegovy® should not be used as a substitute for insulin in patients with type 2 diabetes. Wegovy® should not be used in combination with other GLP-1
receptor agonist products. Patients treated with Wegovy® in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with a GLP-1 receptor agonist. In patients with diabetic retinopathy treated with semaglutide, an increased risk of developing diabetic retinopathy complications has been observed. Patients with diabetic retinopathy using semaglutide should be monitored closely and treated according to clinical guidelines. There is no experience with Wegovy® in patients with type 2 diabetes with uncontrolled or potentially unstable diabetic retinopathy. In these patients, treatment with Wegovy® is not recommended. The safety and efficacy of Wegovy® has not been investigated in patients treated with other products for weight management, with type 1 diabetes, with severe renal or hepatic impairment or with congestive heart failure New York Heart Association (NYHA) class IV. Use in these patients is not recommended. There is limited experience with Wegovy® in patients aged 85 years or more, with mild or moderate hepatic impairment, with inflammatory bowel disease or with diabetic gastroparesis. Use with caution in these patients. If semaglutide is used in combination with a sulfonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines. Fertility, pregnancy and lactation: Women of childbearing potential are recommended to use contraception when treated with semaglutide. There are limited data from the use of semaglutide in pregnant women. Therefore, semaglutide should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, semaglutide should be discontinued. Semaglutide should be discontinued at least 2 months before a planned pregnancy due to the long half-life. In lactating rats, semaglutide was excreted in milk. A risk to a breast-fed child cannot be excluded. Semaglutide should not be used during breast-feeding. Effect on fertility unknown. Undesirable effects: Very common (≥1/10): Headache, vomiting, diarrhoea, constipation, nausea, abdominal pain, fatigue. Common (≥1/100 to <1/10): Hypoglycaemia in patients with type 2 diabetes, dizziness, dysgeusia, dysaesthesia, diabetic retinopathy in patients with type 2 diabetes, gastritis, gastrooesophageal reflux disease, dyspepsia, eructation, flatulence, abdominal distension, cholelithiasis, hair loss, injection site reactions. Uncommon (≥1/1,000 to <1/100): Hypotension, orthostatic hypotension, increased heart rate, acute pancreatitis, delayed gastric emptying, increased amylase, increased lipase. Rare (≥1/10,000 to <1/1,000): Anaphylactic reaction, angioedema. Not known (cannot be estimated from the available data): Intestinal obstruction. The SmPC should be consulted for a full list of side effects. MA number(s): Wegovy® 0.25 mg FlexTouch® EU/1/21/1608/006. Wegovy® 0.5 mg FlexTouch® EU/1/21/1608/007. Wegovy® 1 mg FlexTouch® EU/1/21/1608/008. Wegovy® 1.7 mg FlexTouch® EU/1/21/1608/009. Wegovy® 2.4 mg FlexTouch® EU/1/21/1608/010. Legal category: Product subject to prescription which may not be renewed. For complete prescribing information please refer to the SmPC which is available on www.medicines.ie or by email from infoireland@novonordisk.com or from the Clinical, Medical and Regulatory Department, Novo Nordisk Limited, 1st Floor, Block A, The Crescent Building, Northwood Business Park, Santry, Dublin 9, Ireland. Date last revised: February 2025.
tThis medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Adverse events should be reported to the Health Products Regulatory Authority. Information about adverse event reporting is available at www.hpra.ie. Adverse events should also be reported to Novo Nordisk on Tel: 01 8629700 or complaintireland@novonordisk.com.
References 1. Wegovy® [summary of product characteristics] www.medicines.ie. 2. Rubino D, et al. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes. The STEP 8 Randomized Clinical Trial. JAMA 2022;327(2):138-150. 3. Garvey WT, et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med 2022;28(10):2083-2091. 4. Lincoff AM, et al. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med. 2023;389(24):2221-2232. 5. Vrints C, et al. ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes: Developed by the task force for the management of chronic coronary syndromes of the European Society of Cardiology (ESC). Endorsed by the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024;45(36):3415–3537. 6. ASOI Adult Obesity Clinical Practice Guideline adaptation (ASOI version 1, 2022) by: Le Roux C W1, Fitzgerald I2, Neff K3. Chapter adapted from: Pedersen SD, Manjoo P, Wharton S. Available from: https:// asoi.info/guidelines/pharmacotherapy/ March 2025, IE25SEMO00022
Women across Ireland are suffering in silence when it comes to their vaginal health, according to a new survey conducted by PrecisionBiotics. The research, which polled over 1,000 women, reveals that deep-rooted embarrassment is preventing open discussions, leaving many struggling with issues they feel unable to address.
The survey found that 87 per cent of Irish women believe there is embarrassment around simply using the word ‘vagina’, reinforcing the ongoing stigma surrounding female intimate health. As a result, 78 per cent of women admit they would rather suffer in silence than talk about vaginal health concerns, a worrying statistic that highlights the need for more open conversations, said the researchers.
The research also found that embarrassment extends beyond conversation — 36 per cent of people say they would feel uncomfortable asking for a vaginal health product in a pharmacy. This discomfort is even more pronounced among younger women, with 43 per cent of those aged 18-to-29 admitting they would struggle to request help in-store. Some key findings of the study were:
87 per cent believe that people are embarrassed about using the word ‘vagina’.
84 per cent agree that vaginal health is not spoken about in general conversation.
36 per cent admit they would have a problem with asking for a vaginal health product in a pharmacy, including 43 per cent of 18-to-29 year-olds.
38 per cent of the women polled are aware of and believe in the connection between gut microbiome and vaginal health.
Over half (53 per cent) do not understand what the microbiome is.
43 per cent are aware that the vagina has a microbiome.
53 per cent are aware of products specifically designed for vaginal health.
78 per cent of respondents admit that they think women in general would rather
suffer in silence than mention vaginal health issues.
A quarter of the women polled say they feel worried about their intimate health impacting their physical and mental health. Commenting on the survey results, Corkbased GP Dr Maeve Davis said: “We’ve come a long way in terms of having open conversations around menopause but when it comes to vaginal health, unfortunately it’s still very much taboo. A lot of my female patients find it hard to discuss intimate health, and I would really encourage open conversations about the vagina, particularly in terms of understanding the role a healthy and balanced vaginal microbiome plays in preventing unpleasant infections like thrush, which is very common and can cause a lot of distress and discomfort. I would always tell my patients to prioritise their vaginal health and never feel embarrassed about seeking advice from your doctor or pharmacist if you are worried about this.”
Women’s health advocate Catherine O’Keeffe, AKA Wellness Warrior, said: “I travel to workplaces the length and
breadth of the country and the women I meet often have issues with intimate health that they find hard to speak about, even with their doctor, let alone those close to them. There is a real taboo around this aspect of women's health and we should discuss vaginal health just as we do gut health. This research... backs up my experiences and highlights the fact that we need to shatter taboos around discussing vaginal health and encourage women to seek treatment when needed. The time of suffering in silence is in the past.”
PrecisionBiotics, which has its roots in UCC, has launched new product Women’s Flora, designed for women who are actively seeking to maintain a healthy vaginal balance. The product has been formulated with a unique combination of scientifically studied 4 lactobacilli bacterial strains prevalent in a healthy vaginal microbiome. The company, which is known for its flagship products Alflorex and Zenflore, also recently launched ‘Good Bacteria’ on the Irish market, a daily bacterial supplement for use during or after a course of antibiotics.
A new digital tool, developed by researchers at RCSI University of Medicine and Health Sciences, will provide realtime insights into prescribing trends in Ireland. The interactive platform, known as RxTrends, enables healthcare professionals, policy-makers and researchers to analyse national prescribing patterns, offering a valuable resource for decision-making and policy development.
The RxTrends application is the first of its kind in Ireland, using publicly available data from the Health Service Executive’s (HSE) Primary Care Reimbursement Service (PCRS). It allows users to visualise and compare prescribing rates and costs for medications and therapeutic groups over time, giving a clearer picture of medicine usage across the country.
“Understanding how medicines are prescribed and how costs evolve over time is crucial for improving healthcare policy and practice,” said Prof Frank Moriarty, Associate Professor at RCSI’s School of Pharmacy and Biomolecular
Sciences, who led on the development of the application. “RxTrends provides a user-friendly way to analyse prescribing data, which can help us to ensure more efficient use of medicines, to understand how prescribing aligns with national recommendations, how generic medicines can save costs for the health service, and the impact of new policies.”
The application was developed by Prof Moriarty and Dr Ahmed Hassan Ali, Postdoctoral Researcher at RCSI School of Pharmacy and Biomolecular Sciences, using the R-based Shiny framework and incorporates prescribing and cost data from 2016 to the most recent available data, covering the 100 most frequently prescribed medicines and all therapeutic groups. Users can track trends by selecting specific medicines or broader therapeutic categories, making the tool highly flexible and informative.
Key functionality of the tool includes:
Graphs and trend analyses of medication use and costs over time.
Download data for the time frame and medications of interest.
The ability to assess the proportion of prescribing for a medication within therapeutic groups.
Using the data to explore how medication use changes based on seasonal trends or policies, like Ireland’s Preferred Drug Initiative and the introduction of generic medicines.
While RxTrends represents an important step forward in monitoring medication use in Ireland, researchers emphasise that further improvements could be made, with access to more detailed prescribing data.
The development of RxTrends was part of the CDRx project funded by the Health Research Board and developed with collaborators in University College Cork and the HSE.
The approach for developing the tool has been documented in a newly-published paper detailing its methodology and potential applications.
For more information on RxTrends, visit www.cdrx-project.eu.
By hiding inside macrophages (a type of white blood cell in blood and tissue which is the first line of defence against microbes), Enterobacter lies dormant and does not stimulate any inflammatory responses, allowing it to escape the action of the few antibiotics that remain available for treating the infection.
Enterobacter infections, including wound infections, urinary tract infections, gastroenteritis, meningitis, pneumonia and septicaemia, are serious infections with a high mortality rate, even with appropriate treatment.
This breakthrough could help to develop new ways to treat infected patients and
clear Enterobacter infections more efficiently, leading to less deaths, say the authors.
The study has been published recently in the Journal of Infection Diseases
This research was carried out at the Infection Biology Group of the WellcomeWolfson Institute for Experimental Medicine at Queen’s University Belfast by the Valvano Lab Research Team.
Lead researcher on the study, Prof Miguel A Valvano, Chair in Microbiology and Infectious Diseases from the WellcomeWolfson Institute for Experimental Medicine at Queen’s University Belfast, explained: “Despite extensive information on antibiotic resistance by Enterobacter species, very
little is known about how these bacteria cause infection. Our new study has bridged this knowledge gap by showing for the first time that antibiotic-resistant isolates of Enterobacter species can survive inside human macrophages without being killed.
“The demonstration that Enterobacter isolates can hide inside macrophages has important clinical implications for the treatment of infected patients, since antibiotics cannot reach the intracellular bacteria and the macrophages cannot easily remove them.”
The research was funded by the Biotechnology and Biological Sciences Research Council.
Adex Gel has been shown to improve atopic eczema from moderate to mild
Summary of trial results
In a recent trial of children with moderate atopic eczema, conducted in NHS GP practices (to reflect real-life settings), the mean disease severity score (SCORAD) improved significantly:
• from 37.14 (moderate atopic eczema) at baseline
• to 22.56 (mild atopic eczema) after 2 weeks
• and to 18.48 (mild atopic eczema) after 4 weeks, per protocol analysis of 41 children.
Bridges the gap between plain emollients and topical corticosteroids.
Adex Gel is an emollient with an ancillary anti-inflammatory, nicotinamide 4%, to help reduce inflammation.
Adex Gel can be used continuously, for as long as necessary, all over the body including on the face, hands and flexures. Available on NHS prescription and suitable for patients aged 1 year+.
In addition, the mean children’s dermatology life quality index score (CDLQI) improved significantly from 9.3 (moderate effect on child) at baseline, to 3.7 (small effect on child) after 4 weeks.
Application of Adex Gel in the trial
Three times daily, for 4 weeks, instead of usual emollient or as the first-line treatment for moderate atopic eczema, in both scenarios, without supplementary use of any oral or topical steroids or immunomodulators.
Adex Gel has been shown to be an effective treatment for moderate atopic eczema in children in a real-world setting.
SCORAD is a tool used in clinical trials to assess atopic dermatitis severity based on disease area, intensity and subjective symptoms (itch and sleeplessness). The CDLQI is designed to measure the impact of any skin disease on the lives of children.
Product name: Adex™ Gel. Key ingredients: Isopropyl myristate 15%, liquid paraffin 15%, nicotinamide 4%. Uses: Highly moisturising and protective emollient with an ancillary anti-inflammatory medicinal substance for the treatment and routine management of dry and inflamed skin conditions such as mild to moderate atopic dermatitis, various forms of eczema, contact dermatitis and psoriasis. Package sizes: 100g tube and 500g pump pack. Further information is available from: Dermal Laboratories Ltd, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK. ‘Adex’ is a trademark.
Adverse Events/Incidents should be reported. Reporting forms and information for the UK can be found at yellowcard.mhra.gov.uk, and for the Republic of Ireland at www.hpra.ie. Adverse Events/Incidents should also be reported to Dermal.
SCORAD, SCORing Atopic Dermatitis. CDLQI, Children’s Dermatology Life Quality Index.
Reference: 1. Gallagher J. et al. Evaluation of a nicotinamidecontaining emollient for moderate atopic eczema in paediatric patients:
A prospective, multi-centre GP study reflecting real-life settings. Data presented at the Annual Meeting of the Austrian Society of Dermatology and Venereology (ÖGDV), November 2024, Graz, Austria.
Three Women’s Health Fund projects were launched recently aimed at protecting and improving heart health in women who have, or are at risk of, heart failure.
Supported by €570,000 in funding, the projects are a collaboration between University College Dublin (UCD) and the Heart Failure Unit at St Michael’s Hospital in Dun Laoghaire in association with St Vincent’s University Hospital. The Heart Failure Unit is supported by the HeartBeat Trust in maintaining specialist clinical and research services in heart failure and heart failure prevention in Ireland.
The initiatives, launched during Women’s Health Week, align with the commitments in the Women’s Health Action Plan 20242025 to spotlight cardiovascular health in women. They also contribute to the ongoing evolution of women’s health services.
In Ireland, one-in-four women die from heart disease or stroke, while heart failure is also a significant health issue impacting approximately 50,000 women every year.
The three projects aim to address the disproportionately higher impact of heart failure and cardiovascular disease in women by providing data, developing guidelines and establishing services that will ultimately lead to improvement in prevention, treatment and management of heart conditions.
The three UCD projects operating in St Michael’s Hospital are:
1: Maternal Care Clinic: Cardiovascular Assessment and Risk Evaluation (CARE) following hypertensive disorders of pregnancy and gestational diabetes.
Women who are diagnosed with hypertensive disorders of pregnancy and gestational diabetes are more likely to develop cardiovascular disease in later life. This project will support the development of a personalised service for postpartum cardiovascular risk assessment, to ensure swift treatment to prevent cardiovascular disease later in life.
2: Women’s Initiative for Strengthening Empowerment in Heart Failure and
Tackling Social Determinants of Health
Impacting Self-Care Study (WISE-HF):
This project will examine how the social determinants of health impact on selfcare behaviours of women at risk of and diagnosed with heart failure. It aims to provide valuable data that can be used to address the fact that women are more impacted by socio-economic factors, such as the caring burden in life, and how this affects their ability to self-care and manage their symptom burden.
3: Focus on heart failure among women: Enhancing prevention and early diagnostic strategies.
This project aims to ensure that women who are at risk of heart failure are quickly identified and given appropriate onward referral and management. It involves collaboration between 25 GP practices, with 500 female patients over the age of 40 undergoing a blood test to check for risk factors.
Minister for Health Jennifer Carroll
MacNeill said at the launch:
“The projects I’m launching... are a wonderful example of how research can be used to achieve better outcomes for patients. They will provide valuable insights and data that will inform the design and delivery of better, targeted heart health services and interventions, to ensure women get the appropriate care when they need it.”
Clinical Co-lead of the HSE National Heart Programme and Consultant Cardiologist, St Vincent’s Healthcare Group, Prof Ken McDonald, said:
“Increasingly, we are realising that there are critical differences in the pathway to heart failure among women and how women present and are managed with this condition.
"These areas require specific focus and attention and our group at SVUH Healthcare and UCD are delighted to be leading on this with the support of these Women’s Health Fund-funded projects.”
The NEW ustekinumab biosimilar from Clonmel Healthcare1 Uzpruvo is the first approved ustekinumab biosimilar in Ireland
Cost-effective option enabling improved access to ustekinumab treatment
Equivalent efficacy, safety and immunogenicity to the reference product*2
Patient-friendy PFS: easy handling, thinner needle† , latex-free††1,3
Uzpruvo® is currently not approved for the ulcerative colitis indication (since the originator still has exclusivity for this indication).
PFS - pre-filled syringe. *Stelara®; †29 vs 27-gauge needle of the reference product, Stelara®1,3; ††Plunger stopper made of bromobutyl rubber. 1. Uzpruvo® SmPC (Feb. 2024); 2. Feldman SR et al. Expert Opin Biol Ther. 2023;23(3):253-60. DOI: 10.1080/14712598.2023.2235263; 3. Stelara® PI (Aug. 2022).
UZPRUVO 45 & 90 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE This medicinal product is subject to additional monitoring. Uzpruvo 45 mg: Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL. Uzpruvo 90 mg: Each pre-filled syringe contains 90 mg ustekinumab in 1 mL. Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology. Presentation: Pre-filled glass syringe. Indications: Uzpruvo is indicated for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease. Dosage: Uzpruvo is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which Uzpruvo is indicated. Refer to Summary of Product Characteristics. Method of administration: Subcutaneous injection. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important, active infection. Warnings and precautions: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and Uzpruvo should not be administered until the infection resolves. Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. Serious hypersensitivity reactions have been reported in the postmarketing setting, in some cases several days after treatment. Cases of allergic alveolitis, eosinophilic pneumonia, and noninfectious organising pneumonia have been reported during post-approval use of ustekinumab. Risk factors for cardiovascular disease should be regularly assessed during treatment with ustekinumab. It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with Uzpruvo. Caution should be exercised when considering concomitant use of other immunosuppressants and Uzpruvo or when transitioning from other immunosuppressive biologics. It is not known whether ustekinumab may affect allergy immunotherapy. In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment. Cases of lupus-related conditions have been reported in patients treated with Ustekinumab. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the
elderly. Interactions: Live vaccines should not be given concurrently with Uzpruvo. In psoriasis studies, the safety and efficacy of ustekinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn’s disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of Ustekinumab. Fertility, pregnancy and lactation: Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment. There are no adequate data from the use of ustekinumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Uzpruvo in pregnancy. Limited data from published literature suggests that ustekinumab is excreted in human breast milk in very small amounts. Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with Uzpruvo must be made taking into account the benefit of breast-feeding to the child and the benefit of Uzpruvo therapy to the woman. The effect of ustekinumab on human fertility has not been evaluated. Driving and operation of machinery: Uzpruvo has no or negligible influence on the ability to drive and use machines. Undesirable effects: Upper respiratory tract infection, nasopharyngitis, sinusitis, dizziness, headache, oropharyngeal pain, diarrhoea, nausea, vomiting, pruritus, back pain, myalgia, arthralgia, fatigue, injection site erythema, injection site pain. Refer to Summary of Product Characteristics for other adverse effects. Adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Pack size: 1 pre-filled syringe. A copy of the Summary of Product Characteristics is available upon request or go to www.clonmelhealthcare. ie. Marketing authorisation holder: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany. Marketing authorisation number: EU/1/23/1784/001,004. Medicinal product subject to restricted medical prescription. Date last revised: February 2024.
Date prepared: July 2024. 2024/ADV/UZP/131H
Data showing an 8.8 per cent increase in practising pharmacists in the healthcare workforce and in healthcare activity were highlighted recently, as the latest national data tables on non-monetary healthcare statistics were published. This data allows researchers and the wider public timely access to national information and provides them with a better understanding of Ireland’s data on a range of health topics.
The tables published include national healthcare statistics compiled by the Department of Health as part of the Non-Monetary Health Care Statistics questionnaire, administered jointly by Eurostat, the OEC and the World Health Organisation (WHO). This will be the third edition of the annually published tables, prior to their release by Eurostat and the Organisation for Economic Co-operation and Development (OECD). The data shows:
The number of practising nurses in Ireland in 2024 was 76,558, an increase of 5.5 per
cent from 2023.
The number of practising dentists in Ireland for 2024 was estimated to be 2,560, an increase of 3.8 per cent from 2023.
The number of practicing pharmacists in Ireland in 2024 was 6,250, an increase of 8.8 per cent from 2023.
Graduates in health-related fields of study amounted to a total of 3,455 students in 2023, an increase of 1.6 per cent from the previous year. These fields of study include medicine, nursing, midwifery, dentistry and pharmacy.
Cataract surgery was the most common surgical procedure in Ireland in 2023 with a total of 44,105 procedures, compared with 39,347 procedures in 2022.
There were 13,491 hip replacement procedures in 2023, compared with 12,830 procedures in 2022.
In 2024, a total of 89 MRI units were operational in Ireland, with nearly 85 per cent of them being used in a hospital setting.
A report has been published recently that focused on slush drinks with glycerol.
The research is titled ‘Glycerol Intoxication Syndrome in Young Children, Following the Consumption of Slush Ice Drinks’ and was authored by a group of Irish- and UK-based clinicians and published in the British Medical Journal Archives of Disease in Childhood
Among the report’s recommendations are the avoidance of slush drinks for children below eight years of age.
Slush ice drinks are beverages that can contain glycerol (E 422) as a substitute or partial substitute for sugar. Glycerol helps maintain the slushy texture by preventing
the liquid from freezing solid. Glycerol is an EU approved additive and is used to lower the sugar content of drinks. Glycerol gives ice drinks a slushy effect and whilst it is generally not harmful, there are concerns about its effects on young children under 10 years of age when consumed in large quantities. Slush ice drinks are sold via slush ice machines in a variety of outlets and are also sold pre-packaged in retail stores.
The Department of Health’s Healthy Eating Guidelines has slush ice drinks at the top end of the healthy eating food pyramid, meaning that they are not part of a healthy balanced diet.
Minister for Health Jennifer Carroll MacNeill commented: “Data for 2024 shows a steady increase in the healthcare workforce in Ireland. There is a 4 per cent rise in physicians, a 3 per cent rise in midwives, and a 6 per cent rise in nurses compared to 2023. Additionally, there has been a consistent increase in graduates in these fields. The increase in the number of practising healthcare professionals and the compiled surgical procedure statistics reflect this Government's commitment to enhance the quality of healthcare services in Ireland, and ensure the best outcomes for patients.
“Publishing these national healthcare statistics also highlights our commitment to transparency and the dissemination of vital health information. By providing a means of easy access to this data, we are empowering researchers and the public with the tools they need to gain a deeper understanding of Ireland’s health service.”
Minister of State at the Department of Health with special responsibility for Public Health, Well Being and the National Drugs Strategy Jennifer Murnane O’Connor said: “As a Minister whose portfolio covers food safety and health promotion, I welcome publication of this research paper, and I have asked my Department and the Food Safety Authority of Ireland to review the findings of the paper. Public health for children is a priority for my Department and I will continue to endorse the work of agencies including the Food Safety Authority of Ireland and safefood in this area.”
Queen’s University Belfast, in collaboration with University of Limerick (UL), has launched a new e-resource aimed at educating undergraduate healthcare students on the acute neurological condition of delirium. The resource is part of the Delirium Health Professionals Ireland (DelHPIre) project, an all-Ireland research initiative designed to improve delirium recognition, management, and prevention across various healthcare professions.
Delirium, a condition characterised by rapid deterioration of mental function due to medical disorders or environmental changes, is common in settings such as hospitals and nursing homes. However, its symptoms can often be mistaken for other conditions like dementia, making early detection crucial for improving patient outcomes.
The newly-launched e-resource is designed to raise awareness of delirium among students in a variety of healthcare fields, including pharmacy, medicine, nursing, occupational therapy, social work, and dietetics. The comprehensive online resource provides a range of information on delirium, including assessment, management, prevention and the provision of multidisciplinary person-centered holistic care to people with delirium. This is supplemented by video, audio, and interactive activities.
Co-designed by researchers and students from both UL and Queen’s University Belfast, this project was funded by the Higher Education Authority (HEA) under the NorthSouth Research Programme.
The Principal Investigators on the DelHPIre project are Dr Gary Mitchell, School of Nursing and Midwifery, Queen’s University Belfast, and Prof Alice Coffey, School of Nursing and Midwifery, University of Limerick.
Commenting on the significance of this work, Dr Mitchell said: “This project and the e-resource highlight the importance of cross-border collaboration in education. By making high-quality, research-informed materials accessible, they support educators
and students across Ireland and Northern Ireland. The e-resource is already being integrated into curricula in Northern Ireland, ensuring its impact on teaching and learning. This work reflects our shared commitment to being stronger together as researchers, educators, and practitioners.”
Prof Coffey added: “This resource has the potential to shape the provision of undergraduate delirium education across the island of Ireland. Throughout the project, we have encouraged the shared and collective voice of our students, who will use and benefit from this resource. The use of co-design methodology ensured that the voice of the end-users, health professional students, was key in informing the development of the learning resource.”
Students who participated in the development of the resource have shared their experiences and insights.
Karen Mulvihill, student of pharmacy from Queen’s University Belfast, explained how the resource has informed her own work: “This project showed the impact and
the importance of multidisciplinary input at an educational level. As my background is in pharmacy, I have limited experience working in multidisciplinary teams in comparison with medicine, nursing and allied health students who are on the front line with patients. The e-resource is comprehensive, easy to follow, and it shows that even simple measures can have a massive difference.”
Sinead Kirby, student of mental health nursing at UL, said: “I benefitted from getting a deeper understanding of what delirium is, the importance of the prevention, and the non-pharmacological interventions that we can do, not just the medications. I enjoyed the co-design and collaboration between the two universities and getting to know the students from all the different disciplines during the workshops. Our voices and opinions were heard, and we felt like we all had an important part to play in caring for a person with delirium.”
The multidisciplinary delirium e-resource for healthcare professional students can be accessed at https://deliriumeresource.com/.
Trinity College Dublin recently hosted the inaugural meeting of a new concussion advocacy group, which brings together researchers, medics, sportspeople and charities, and puts the burning issue of concussive brain injuries in sports such as rugby, GAA, football, and boxing firmly in the spotlight.
Concussive brain injuries in sports have become the focus of increased medical, scientific and public scrutiny over the past decade, yet our understanding of the longterm consequences of these injuries on brain health is still far from clear. Added to that, the views and concerns of the sports participants, current and past, have not been officially recognised or addressed.
Here, in an initiative driven by Dr Mick Molloy, the inaugural meeting of the concussion advocacy group was held at the Smurfit Institute of Genetics in Trinity College Dublin.
Dr Molloy is a former Irish rugby union player and served as a member of the International Rugby Board Medical Advisory Committee, and in 2005 was appointed as the IRB's first ever medical officer. He has been recognised internationally for his achievements, particularly in the key areas of global injury surveillance and the development of concussion guidelines.
Dr Molloy said: “When driving the conversation on improvements in concussion identification, management and treatment, it is essential that the public and participant voice is front and centre. We have established this advocacy group to be the focal point for Ireland in developing cohesive concussion guidelines across all sporting codes.”
Prof Colin Doherty, Head of the School of Medicine at Trinity, added: “It is absolutely critical that we continue to develop the highest levels of research that will
Minister for Mental Health, Mary Butler TD, recently launched a public consultation to inform the development of Ireland’s next suicide reduction policy.
The consultation is an opportunity for members of the public, stakeholder groups and organisations to share their experience, observations and proposals on suicide reduction in Ireland and to express what they would like to see in a new policy. The current suicide reduction strategy, Connecting for Life, is being evaluated, with a final report due in the first half of this year. The successor policy, which this new consultation process will feed into, will build on the successes of Connecting for Life and will take account of new evidence. The new policy will set out the Government’s approach to suicide reduction from 2026 onwards.
The information from the public
consultation will be collated and analysed by the National Suicide Research Foundation and a report will be prepared for the Department of Health. This report will be used to inform the development of the next suicide reduction policy.
The new policy will also be based on learnings from the independent evaluation of the current policy Connecting for Life, lessons from around the world on other successful reduction strategies, and a review of the latest research on effective suicide prevention.
The closing date for the public consultation is 5pm on Friday 18 April 2025.
Minister Butler said: “Preventing the tragedy of suicide remains a priority for me and this Government and it is hugely important that we keep working to reduce suicide in Ireland. There is no greater
lead to the next generation of clinical management of concussive brain injuries. It is only by opening the conversation to all stakeholders that this will happen.”
And as part of the Trinity Research Doctorate awards (TRDA) programme, the event showcased the projects of five PhD students who are each working on various aspects of concussion research, including pre-clinical and clinical research endeavours, the societal implications of head injuries, and the associated legal implications.
“The TRDA programme will take the lead nationally in developing a training network for the next generation of scientists, clinicians and legal professionals that will focus on how we deal with the impact of concussion in society,” said Prof David Loane, Associate Professor of Biochemistry in Trinity’s School of Biochemistry and Immunology.
tragedy than someone deciding that life is not worth living. In my role, I hear heart-breaking personal stories from people whose lives have been devastated by suicide. This public consultation is an important opportunity for those voices to be heard at a national level and be incorporated into our next policy to reduce suicide in Ireland.
“All experiences shared as part of this process are unique and we recognise the hugely important contribution people with lived experience of suicide bring to suicide prevention. Feedback received will inform the development of Ireland’s next suicide reduction policy and I encourage everyone to take part in the consultation process, be it online or by attending the in-person events that the Department of Health will be running in March, April and May.”
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An expert taskforce has laid the groundwork for the expansion of pharmacy services. Pat Kelly examines the practicalities for pharmacists, doctors, and for patient care
In July 2024, the Department of Health released the Final Report from the Expert Taskforce to Support the Expansion of the Role of Pharmacy. It contained a range of recommendations aimed at improving access to care in “the evolving healthcare landscape”.
The expert taskforce was established in 2023. It was given the remit of identifying and supporting the expansion of the role of pharmacists, including prescribing powers for common ailments. The final report maps out a pathway to implementing pharmacist prescribing, initially within the Common Conditions Service (CCS).
Over time, pharmacists should be enabled to exercise independent, autonomous prescriptive authority within their individual scope of practice and competence, according to the report.
The report cites studies on pharmacist prescribing models to manage minor ailments in the UK, US, Canada, and New Zealand, including systematic reviews and pilot projects in these jurisdictions.
A research sub-committee was assembled in February 2024, chaired by a taskforce member, and included participants appointed from research and practice settings. The report authors say the recommendations are supported by national and international experience and are founded in academic research and practice, as well as submissions from a public consultation.
At almost 100 pages long, the final report outlines the operational, strategic, and regulatory frameworks necessary to achieve this objective.
The Department emphasises that full pharmacist prescribing authority, and increased pharmacist autonomy, is
intended to enhance patient care, optimise healthcare resources, and support the development of Ireland’s healthcare system.
The final report follows an interim report that recommended pharmacists be enabled to extend six-month prescriptions by an additional six months, where safe and appropriate. The Minister for Health subsequently accepted the proposals and implemented the scheme.
The taskforce recommendations have been the subject of debate. Some within the medical profession have expressed concerns, which they say are based on patient safety.
The Irish Medical Organisation (IMO) informed this reporter that it has “serious
concerns” about the proposals. “Doctors and pharmacists have a long history of collaboration, each working together in their different roles,” said its spokesperson. “However, in response to the challenges facing healthcare systems today — of an ageing population, increased rates of chronic disease, economic constraints and a shortage of doctors — many jurisdictions have sought to expand the role of pharmacists into activities normally carried out by doctors.
“The IMO is concerned that the transfer of tasks from doctors to pharmacists is unsupported by the evidence and has implications for patient safety, quality of care, healthcare sustainability, and fragmentation of care.”
One of the rationales for the proposals
was to reduce pressure on general practice. However, the IMO sees this prospect as creating more problems than it solves.
“The implication that an increased role for pharmacy in prescribing will help reduce demand on general practice shows a profound misunderstanding of the importance of continuity of care in general practice and risks further fragmentation of care,” according to the Organisation.
The IMO said international evidence shows the importance of continuity of care. It stated that the new proposals would damage this chain of patient care. “Many conditions can deteriorate significantly over time and prescriptions are issued by a medical practitioner for a limited time to allow for review,” said the IMO spokesperson.
“In addition, prescribed medicines may cause adverse reactions, interact with other pharmaceutical products or doses may need to be adjusted, depending on the individual. All of these are issues which are addressed during the review.”
The IMO also stressed the importance of GP-patient relationships: “It is often during these interactions that items of care such as opportunistic screening take place and afford opportunity to discuss lifestyle and disease prevention,” it said. “Time-intensive consultations for complex illness may not always afford the same opportunities.”
The Irish College of GPs was contacted but declined to comment on the proposals.
The Irish Pharmacy Union (IPU) has broadly welcomed the recommendations, but has concerns around some of the plans, particularly in regard to capacity.
“A critical pillar supporting the advancement of pharmaceutical care services in Ireland is the importance placed on the strategic allocation and utilisation of human resources,” the IPU stated. “However, the current landscape reveals a significant deficiency in cohesive workforce planning, hindering the development of an integrated pharmacy care model.”
An integrated pharmacy care model would greatly assist in workforce planning, the IPU argues, and should be led by a Chief Pharmaceutical Officer (CPO) to drive
policies and planning. CPOs are already in place in Northern Ireland, England, Wales, and Scotland. “Strategic workforce planning, led by a CPO, is vital for ensuring continuity and uptake by the profession, addressing skill gaps, enabling and enhancing access to pharmacy education, encouraging professional development, and maintaining appropriate staffing levels,” the spokesperson continued.
The Irish Institute of Pharmacy (IIOP) delivers a CPD system for pharmacists in Ireland and helps to develop pharmacy practice in line with international practice and “evolving healthcare needs”. As acknowledged by the Department of Health, educational training courses underpinned by legislative and regulatory authority will be required for pharmacists.
As the recommendations are implemented, the IIOP — as part of the Pharmaceutical Society of Ireland (PSI)— will be instrumental in supporting pharmacists through the transition. “Our role is to support PSI, DoH, HSE and the pharmacy profession by providing training that enables pharmacists to engage in the services associated with implementation of taskforce recommendations,” the Institute commented.
“The IIOP website, resource hub and training programmes provide accessible, quality-assured, contemporaneous training and sources of information for all pharmacists. Last August, we provided webinars, workshops and information through the IIOP resource hub to support pharmacists in relation to the prescription extension service. We anticipate that we will provide similar types of resources to support the common conditions service.”
The taskforce’s final report provides examples of how common conditions services — also known as ‘minor ailment’ or ‘common ailment’ schemes — work in other jurisdictions by enabling pharmacists to treat self-limiting conditions. According to the Department, this will release capacity in other areas of the health service and improve equity of access to care.
The final report cites policy evidence from other countries to show that pharmacist prescribing for common ailments resulted in clinical improvements.
However, the IMO has serious reservations around the introduction of pharmacist prescribing, which it describes as a “quality of care” issue.
“Pharmacy prescribing of oral contraceptives has been introduced largely to support ease of access, however the progesterone-only pill has been found to be less effective than other long-acting forms of contraception at reducing unplanned [pregnancies], and studies also show that women are more likely to choose this form of contraception if they receive comprehensive information from their GP,” the IMO commented. “Furthermore, sexual health is not just about contraception and preventing unwanted pregnancies. Access to contraception should form part of a comprehensive women’s sexual health programme in general practice that also includes advice on STIs, fertility, and pre-conception. The assessment and consultation with the GP provide an invaluable opportunity to check in on particularly vulnerable patients…”
‘Conflict of interest’
However, the IMO went further and suggested a potential conflict of interest issue in terms of pharmacist prescribing powers. “Patients and the State have always been well served by the separation of the prescriber (the doctor) and the dispenser (the pharmacist) role, as a clear conflict of interest can arise when a healthcare professional incurs a financial gain from the medicine they prescribe,” the IMO told this reporter. “Legislators and regulators must be compelled to recognise that a clear conflict of interest arises when a pharmacist takes on an expanded prescribing role, particularly given the growing number of retail pharmacy chains and the vertical integration of pharmaceutical wholesale distribution and pharmacy retail.
“Other areas of concern are ‘linked sales’ policies, which link the purchase of one pharmaceutical product to other pharmaceutical products which may or may not be necessary,” the IMO continued. “Pharmacists frequently stock and sell vitamin supplements, homeopathic remedies and other products
of limited or no proven therapeutic value. Recently, doctors have witnessed a considerable market drive by pharmacists to sell near-patient testing kits, which present a considerable risk of incorrect diagnosis, over-diagnosis, as well as under-diagnosis. Pharmacists also offer services such as 24-hour ambulatory blood pressure monitoring, ECGs, with no context in which to interpret the data nor expertise to treat it.”
The union reiterated the importance of the GP-patient relationship. “International evidence shows that patient-focused continuity of care in general practice is key to improved patient outcomes, reduced inequalities in health, and longterm cost-effectiveness. Continuity of care is also an essential part of chronic disease management. Many conditions can deteriorate significantly over time and prescriptions are issued by a medical practitioner for a limited time to allow for review,” the IMO added.
The IPU, in contrast, was positive about the recommendations, stating that it looked forward “to working with all stakeholders to support this important modernisation of Ireland’s healthcare system for the benefit of the population”. However, it continues to express concern about investment in the sector. “The recommendations outlined in the report support the vision of Sláintecare to expand community-based care to bring care closer to home and to ensure equity of access to healthcare based on clinical need and not ability to pay,” it commented. “Successful implementation of the taskforce recommendations requires a sustainable pharmacy model, and multi-annual investment in pharmacy services is a key element to that.”
On one issue, both the IMO and IPU are in agreement — each of their sectors requires better supports from Government. “Currently, there is a capacity issue in general practice and further supports are needed,” the IMO stressed. “However, the diversion of care from GPs to pharmacists risks further fragmentation of care, increased medicalisation and consequently, workload for GPs.”
The IMO was also keen to point out that it is not fundamentally against all pharmacist prescribing. “…The IMO recognises that there may be value to patients and the State in allowing pharmacists to extend prescriptions in certain emergency situations, and in allowing GMS patients to access certain OTC drugs without prescription which are currently available to private patients,” it added.
“Rather than supporting pharmacy prescribing, further consideration should be given to supporting the integration of non-commercial/non-retail pharmacists, to enhance prescribing safety, either as part of the practice team or at the request of the GP.”
The union concluded by advocating for “non-commercial/non-retail pharmacists to enhance prescribing safety, either as part of the practice team or at the request of the GP as per the 2019 GP agreement between the IMO, the Department of Health and the HSE”. ●
1. That pharmacists be enabled to exercise independent, autonomous prescriptive authority within and related to the individual practitioner’s scope of practice and competence.
2. This should be implemented in a stepwise manner, commencing with the introduction of a common conditions service, with pharmacists provided with prescriptive authority linked to the service and its parameters.
3. The development, over the coming years, of models of pharmacist prescribing within primary and secondary care settings, recognising the requirements for specific enablers.
The Taskforce also issued guidance to assist in the implementation of the overarching recommendations. These are detailed below.
Patient and public involvement: The inclusion of patients and the public in the implementation, research and review of the recommendations made by the Taskforce.
Regulatory framework and legislative amendments: A regulatory framework, including legislation, standards, guidance, and education requirements be developed in tandem by the responsible and accountable entities.
Leadership and governance: Leadership for the profession at a senior level within the Department of Health.
Education and training: Educational courses of training underpinned by legislative and regulatory authority.
Operational and infrastructure resourcing requirements: Operational and resourcing supports, including supporting technology, information communication, and
infrastructure, should be facilitated to evolve to streamline administrative processes, optimise interprofessional communication, and facilitate recording, reporting and feedback between professions involved in the care of a particular patient, and to facilitate research. These resources are essential to the timely and safe implementation of these recommendations.
Communication and engagement: Campaigns to inform the public about the CCS, highlighting the change in practice and the new services available, as well as the safety and efficacy of the new service. Engagement with stakeholders to inform the implementation of pharmacist prescribing is also envisaged.
Research and review: Ongoing research to provide the implementation with a strong Irish evidence base. Review of the change in policy to ensure the services are achieving their goals are being achieved in accordance with good governance policies and procedures.
Salicylic acid, lactic acid.
Supplied in a complete treatment kit, with a simple once daily application, Salatac Gel offers a very convenient and painless way of treating warts and verrucas. Salatac Gel dries to a water-resistant film... no need for plasters.
Prescribing information
Salicylic acid 12.0% w/w, lactic acid 4.0% w/w. Uses: For the topical treatment of warts, verrucas, corns and calluses.
Directions: Adults, children and the elderly: Apply once daily until the wart, verruca, corn or callus has disappeared (treatment may take up to 12 weeks). Soak the affected area in warm water for 2-3 minutes and dry with patient’s own towel. Carefully apply one or two drops to the lesion avoiding the surrounding skin. (Peel off the previous day’s gel before reapplying). Once a week gently rub away the treated surface with an emery board to remove any hard skin before re-application of the gel.
Contra-indications, warnings, side effects etc: Please refer to SPC for full details before prescribing. Do not use if sensitive to any of the ingredients. Not to be used on or near the face, intertriginous or anogenital regions, or by diabetics or individuals with impaired peripheral blood circulation. Not to be used on moles or on any other skin lesions for which it is not indicated. Keep away from the eyes, mucous membranes and from cuts and grazes. Some mild, transient irritation may be expected, but in cases of more severe or persistent pain/irritation, the treatment should be suspended or discontinued. Avoid inhaling vapour. Highly fl ammable, keep away from fl ames.
Package quantity, trade price and MA number: 8g tube with applicator. €6.22, PA23128/007/001
Legal category: Supply through pharmacy only.
Further information is available from: Dermal Laboratories (Ireland) Ltd, Head Offi ce Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK.
Date of preparation: October 2023.
‘Salatac’ is a trademark.
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Dermal.
Recently, the European Commission (EC) has proposed a Regulation to improve the availability of critical medicines in the EU. The proposal aims to protect human health by incentivising supply chain diversification and boosting pharmaceutical manufacturing in the EU. This will support the EU's pharmaceutical sector, which is a major contributor to the European economy. The Act also aims to improve access to other medicines of common interest, which may not be available in certain markets. This initiative contributes to the European Health Union's goal of ensuring that EU patients have access to the medicines they need, when they need them.
EC President Ursula von der Leyen announced the Critical Medicines Act in her political guidelines to reduce dependencies and enhance the EU's resilience, particularly for medicines and active ingredients where there are only few supplying manufacturers or countries.
In recent years, Member States have been confronted with serious medicine shortages and global challenges such as the Covid-19 pandemic, and geopolitical tensions clearly exposed significant vulnerabilities in the EU's pharmaceutical supply chain. Shortages can put patients' lives at risk and place a significant burden on our healthcare systems. These shortages can be caused by manufacturing problems, supply chain vulnerabilities, or global competition for resources. The Critical Medicines Act aims to provide an industrial toolkit to address these problems, by making the EU a market in which producing critical medicines will be more attractive.
The Act will facilitate investments for companies that increase EU manufacturing of critical medicines, while incentivising actions that make supply chains more resilient. It will also offer Member States the possibility to join together to increase their purchasing power.
Key elements of the Critical Medicines Act include:
Strategic projects will create, increase or modernise EU manufacturing capacity for critical medicines or their ingredients. These industrial projects may benefit from easier access to funding and fasttracked administrative, regulatory and scientific support.
State aid guidance has been published to assist Member States in financially supporting such strategic Projects.
Member States can use public procurement to diversify and incentivise the resilience of supply chains. For critical medicines, procurers will have to include a broader set of requirements in their procurement procedures, such as diversified sources of input material and monitoring of supply chains. In case of high dependency on a single or a limited number of countries, they will also have to use procurement requirements that favour critical medicine production in the EU. This will also be possible for other medicines of common interest, when justified.
The Commission will support collaborative procurement among different Member States at the request of Member States, to address availability and access disparities of critical medicines and other medicines of common interest throughout the EU.
International partnerships with likeminded countries and regions will be
explored, to broaden the supply chain and reduce dependencies on a single or limited numbers of suppliers.
Tackling shortages and ensuring access to medicines have been a priority for the EU for many years. The 2020 Pharmaceutical Strategy for Europe set out a series of regulatory measures and additional support for industry to promote research and innovation in the area of medicinal products, while addressing shortages and lack of access for patients. It also led to the launch of a Structured Dialogue on the industrial dimension of security of supply with all stakeholders.
In 2022, the European Medicines Agency (EMA) was given a stronger mandate to manage shortages. Since then, together with groups of national authorities, it has played a key role in monitoring and responding to critical medicine shortages.
In 2023, the Commission proposed an ambitious overhaul of the EU's pharmaceutical legislation, to improve access and strengthen the supply chains of medicines. This reform is currently being negotiated by the European Parliament and Council. Further initiatives taken include the publication of a union list of critical medicines, to help identify and monitor critical medicines; and a Commission Communication on addressing medicine shortages in the EU.
The Critical Medicines Act complements these measures with industrial policy tools to address supply chain vulnerabilities of critical medicines and reduce the EU's dependencies in this strategic area. ●
37.5 mg (additional strength)
Indications
Venlatev 37.5 mg, 75 mg and 150 mg hard prolonged-release capsules
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
Treatment of generalised anxiety disorder.
Venlatev (venlafaxine hydrochloride) Hard Prolonged-Release Capsules Abbreviated Prescribing Information. Presentation: Each hard prolonged-release capsule contains venlafaxine hydrochloride, equivalent to 37.5mg, 75mg and 150mg of venlafaxine respectively. Indications: Treatment of major depressive episodes, generalised anxiety disorder, social anxiety disorder, and panic disorder, with or without agoraphobia. Also indicated for the prevention of recurrence of major depressive episodes. Dosage and administration: For oral use. Adults: For the treatment of major depressive episodes, the recommended dose is 75m/day, up to a maximum of 375mg/day for patients not responding to the initial dose (dose increases can be made at no less than 4-day intervals). For generalised anxiety disorder and social anxiety disorder, the recommended dose is 75mg/day, up to a maximum of 225mg/day (dose increases can be made at intervals of 2 weeks or more). For panic disorder, the recommended dose is 37.5mg/day for 7 days, then increased to 75mg/day, up to a maximum of 225mg/day (dose increases can be made at intervals of 2 weeks or more). Treatment across all indications should be assessed on a case-by-case basis. Consult the SmPC for full details. Children and Adolescents: Not recommended for use in children and adolescents under the age of 18 years. Elderly: No specific dose adjustments of venlafaxine are considered necessary based on patient age alone, however, caution should be exercised in treating the elderly. The lowest effective dose should always be used. Renal impairment: No change in dose is necessary for patients with glomerular filtration rate (GFR) between 30-70 ml/minute, however, caution is advised. For patients that require haemodialysis and in patients with severe renal impairment (GFR < 30 ml/min), the dose should be reduced by 50%. Because of inter-individual variability in clearance in these patients, individualisation of dosage may be desirable. Hepatic impairment: In patients with mild and moderate hepatic impairment, in general a 50% dose reduction should be considered. However, due to inter-individual variability in clearance, individualisation of dose may be desirable. There are limited data in patients with severe hepatic impairment. Caution is advised, and a dose reduction by more than 50% should be considered. The potential benefit should be weighed against the risk in the treatment of patients with severe hepatic impairment. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome. Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible MAOI. Precautions and warnings: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts and should receive careful monitoring during treatment. As with other serotonergic agents, serotonin syndrome, a potenially life-threatening condition, may occur with venlafaxine treatment, particularly with concomitant use of other substances that affect the serotonergic neurotransmitter system. If concomitant treatment with venlafaxine and other medicinal products that may affect the serotonergic and/or dopaminergic neurotransmitter systems is clinically warranted, careful observation of the patient is advised, particularly during treatment
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
initiation and dose increases. Mydriasis may occur in association with venlafaxine. It is recommended that patients with raised intraocular pressure or patients at risk for acute narrow-angle glaucoma (angle-closure glaucoma) be closely monitored. Dose-related increases in blood pressure have been commonly reported with venlafaxine. In some cases, severely elevated blood pressure requiring immediate treatment has been reported in post-marketing experience. All patients should be carefully screened for high blood pressure and pre-existing hypertension should be controlled before initiation of treatment. Increases in heart rate can occur, particularly with higher doses. Caution should be exercised in patients whose underlying conditions might be compromised by increases in heart rate. Venlafaxine has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease, therefore, it should be used with caution in these patients. Convulsions may occur with venlafaxine therapy. Venlafaxine should be introduced with caution in patients with a history of convulsions, and concerned patients should be closely monitored. Treatment should be discontinued in any patient who develops seizures. Cases of hyponatraemia and/or the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion may occur with venlafaxine. Venlafaxine should be used cautiously in patients predisposed to bleeding, including patients on anticoagulants and platelet inhibitors. Clinically relevant increases in serum cholesterol were recorded in venlafaxine-treated patients, therefore, measurement of serum cholesterol levels should be considered during long-term treatment. Mania/ hypomania may occur in a small proportion of patients with mood disorders who have received antidepressants, including venlafaxine. Venlafaxine should be used cautiously in patients with a history or family history of bipolar disorder. Aggression may occur in a small number of patients who have received antidepressants, including venlafaxine. The use of venlafaxine has been associated with the development of akathisia. In patients with diabetes, treatment with an SSRI or venlafaxine may alter glycaemic control. Insulin and/or oral antidiabetic dose may need to be adjusted. Serotonin-norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction. There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SNRIs. Venlafaxine should be gradually tapered when discontinuing treatment over a period of several weeks or months according to the patient’s needs. Interactions: Venlafaxine must not be used in combination with irreversible non-selective MAOIs. Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI. Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible non-selective MAOI. Due to the risk of serotonin syndrome, the combination of venlafaxine with a reversible and selective MAOI, is not recommended. may occur with venlafaxine treatment, particularly with concomitant use of other agents that may affect the serotonergic neurotransmitter system. If concomitant treatment with venlafaxine and an SSRI, an SNRI or a serotonin receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of venlafaxine with serotonin precursors is not recommended. Caution is advised if a patient’s therapy includes a CYP3A4 inhibitor and venlafaxine concomitantly, as this may lead to an increase in levels of venlafaxine and O-desmethylvenlafaxine Serotonin syndrome may occur with the concomitant use of venlafaxine and lithium. Caution should be exercised with co-administration of venlafaxine and imipramine and metoprolol. Pregnancy and lactation: Venlafaxine must only be administered to
Treatment of social anxiety disorder.
Treatment of panic disorder, with or without agoraphobia.
pregnant patients if the expected benefits outweigh any possible risk. Discontinuation symptoms may occur in the newborns if venlafaxine is used until or shortly before birth. Some newborns exposed to venlafaxine late in the third trimester have developed complications requiring tube-feeding, respiratory support or prolonged hospitalisation. Such complications can arise immediately upon delivery. Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SSRI/SNRI exposure within the month prior to birth. A risk to the suckling child cannot be excluded, therefore, a decision to continue/discontinue breastfeeding or to continue/discontinue therapy with Venlatev should be made, taking into account the benefit of breast-feeding to the child and the benefit of Venlatev therapy to the woman. Effects on ability to drive and use machines: Venlatev may impair judgment, thinking, and motor skills. Therefore, any patient receiving venlafaxine should be cautioned about their ability to drive or operate hazardous machinery. Adverse reactions: Agranulocytosis, aplastic anaemia, pancytopaenia, neutropaenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, thrombocytopenia, delirium, neuroleptic malignant syndrome (NMS), serotonin syndrome, convulsion, tardive dyskinaesia, suicidal ideation, suicidal behaviours, Torsade de pointes, ventricular tachycardia, ventricular fibrillation, angle-closure glaucoma, pancreatitis, hepatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, rhabdomyolysis. Very Common: Insomnia, headache, dizziness, sedation, nausea, dry mouth, constipation, hyperhidrosis (including night sweats). Common: Decreased appetite, confusional state, depersonalisation, abnormal dreams, nervousness, libido decreased, agitation, anorgasmia, akathisia, tremor, paraesthesia, dysgeusia, visual impairment, accommodation disorder, including blurred vision, mydriasis, tinnitus, tachycardia, palpitations, hypertension, hot flush, dyspnoea, yawning, diarrhoea, vomiting, rash, pruritus, hypertonia, urinary hesitation, urinary retention, pollakiuria, menorrhagia, metrorrhagia, erectile dysfunction, ejaculation disorder, fatigue, asthenia, chills, weight decreased/increased, blood cholesterol increased. Consult the SmPC in relation to other side effects. Overdose: In post-marketing experience, overdose with venlafaxine was reported predominantly in combination with alcohol and/or other medicinal products, including cases with fatal outcome. Severe poisoning symptoms may occur in adults after intake of approximately 3g of venlafaxine. Published retrospective studies report that venlafaxine overdose may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressants, but lower than that for tricyclic antidepressants. Severe poisoning may require complex emergency treatment and monitoring. Therefore, in event of suspected overdose involving venlafaxine, prompt contact with national poison information centre is recommended. General supportive and symptomatic measures are recommended; cardiac rhythm and vital signs must be monitored. When there is a risk of aspiration, induction of emesis is not recommended. Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Administration of activated charcoal may also limit absorption of the active substance. Legal category: POM. Marketing
Authorisation Number: PA1986/099/001-003. Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands. Job Code: MED-IE-00085. Date of Preparation: September 2024.
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie.
Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com
Prescription Only Medicine. Further information is available on request or in the SmPC. Product Information also available on the HPRA website.
Date of Preparation: January 2025 | Job Code: 00100
Generic, biosimilar and value added medicines industry call for transition to digital-first communications to improve environmental impact and end wasteful duplication of resources
Medicines for Ireland (MFI) recently highlighted the urgent need for transition to digitalfirst communication with healthcare professionals to reduce inefficiencies, environmental impact, and rising costs. Under the current paperbased system, pharmaceutical manufacturers are mandated to print and distribute safety information separately, even when multiple companies are providing the same information for the same medicine. This is resulting in thousands of printed materials being sent to healthcare professionals, much of which is redundant. Data provided by 75 per cent of MFI members shows they were required to print over 1.2 million pages or 6.3 metric tonnes of safety communications in the past three years. The cost of this amounted to more than €700,000 to print, store and distribute.
Chair of Medicines for Ireland, Mr Paul Neill, emphasised the scale of waste caused by the current system ahead of MFI’s ‘Digital Solutions for a Greener Industry’ event recently. Commenting, Mr Neill said: “Very often when a generic or biosimilar medicine is launched, multiple pharmaceutical companies are required to send the same printed safety communication to the same healthcare professionals. The only differentiating factor is the logo at the top of the page. This duplication is inefficient, environmentally damaging, and unnecessary in an era where digital
alternatives are available.
“There is a real opportunity to drive innovation within the Irish healthcare system through enhanced use of digital communications. This is being realised is other European countries like the Netherlands, where the policy for sending direct healthcare professional communications (DHPC) and recall letters has shifted towards digital. The Dutch hybrid system allows for important risk communications to be delivered quickly via email to healthcare providers, while those without a registered email address continue to receive them by post. The Swedish Medicines Agency has also introduced a similar pilot study where important drug information is sent to the digital mailboxes of concerned prescribers."
“Without a clear pathway to digital communications between industry and healthcare professionals in Ireland, we risk falling behind in our ability to communicate critical safety information efficiently and effectively. As a first step, we must consider how the advancements and learnings from our European neighbours can be replicated, complementing the ambition around digital connectivity across the wider Irish healthcare system,” Mr Neill added.
MFI’s ‘Digital Solutions for a Greener Industry’ event brought together experts and representatives from across the healthcare sector to explore the benefits, opportunities, and challenges of transitioning to a digital-first model. Hosted in the Royal Irish Academy in
Dublin 2, attendees heard perspectives from the Irish Pharmaceutical Union (IPU), and the Health Products Regulatory Authority (HPRA).
Highlighting the advantages, Vice Chair of Medicines for Ireland, Deirdre Kelly, said: “The way we communicate has changed dramatically, particularly since the pandemic, yet our sector remains heavily reliant on outdated systems that have not kept pace with technological advancements. Other European countries have successfully adopted digital-first safety communications without compromising patient safety. Ireland must modernise its approach to align with best practices and reduce unnecessary waste.
“There are many examples of advancements in utilising the use of technology within the Irish health sector in recent years. We have recently seen the launch of the HSE patient app and a successful pilot of electronic health records for patients with a commitment to introduce EHRs across the system in the Digital Health Strategy. All of these are to be welcomed and commended. Our members are very much committed to working in partnership with all stakeholders involved to ensure a pathway to achieving the benefits of digital-first communications between industry and healthcare professionals are found.”
For more information about Medicines for Ireland and the conference, visit www.medicinesforireland.ie. ●
“ Cow’s milk allergy is associated with dysbiosis
OURPATENTED COMBINATION REDUCED CONSTIPATION and abdominal discomfort5^ SUPERIOR PALATABILITY compared to other EHFs in Ireland6 and the UK 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.
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.
^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
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
Is AI our friend, foe, or both, asks Fintan Moore
There used to be a joke many years ago that there are three forms of intelligence: Human intelligence, animal intelligence, and military intelligence… in that order. It was possibly a bit mean to the military, but then again, a lot of people might say it was funny because it was true.
Personally, I think it’s a bit unfair
to the animals — if a dog has food, shelter, walks, and company, he’ll invariably be happy, whereas a depressingly large number of humans are still liable to work themselves to an early grave trying to accumulate more stuff that they don’t need.
Anyway, the joke has been overtaken by time and the advent of Artificial Intelligence (AI) as a fourth
option — and it’s hard to know where to rank AI.
There are definitely ways in which AI can make life easier. I’ve spoken to computer programme developers who use AI to do some of the work they used to delegate to more junior programmers, and they say the AI product is accurate and available almost instantly. On the flip side, I’ve
spoken to university lecturers who frequently see work handed in by students that has been generated partially or fully by AI, with mixed results in terms of quality.
One lecturer even recognised that a thesis submission actually contained some of her own work, which the student had unwittingly plagiarised by sloppy use of AI. That story probably counts as a failure of human intelligence but it does show that AI, if left to its own devices, won’t always be your friend, which is a point worth remembering in the world of pharmacy.
There will undoubtedly be ways that AI can help us to do our work as pharmacists. For example, if patients want to learn more about their medication, they can quickly and easily ask AI a question and get an instantaneous response.
However, there is an inherent risk involved in doing this because AI assembles its answers based on a trawl of sources on the Internet, and it combines relevant words into sentences using the frequency of them appearing together in those sources. This is an impressive feat, but it’s not foolproof by any means. The smart way forward will probably involve training selected AI to acquire information only from specific sources that can be trusted, and then recommending patients to preferentially use this AI.
Five years later
It’s hard to believe that five years have passed since Covid-19 crashed into everyday life. In pharmacy, the 'Big Bang moment' was probably the morning of Thursday 12 March, when Leo Varadkar announced that schools and colleges would close for two weeks, large gatherings were cancelled, and that people should work from home if possible. That pressed the pandemonium button and everyone rushed to stock up on bread
and toilet roll.
I was off that morning, so I watched the speech at home then drove to work to troubleshoot the craziness. Some patients wanted three months of their medication because they had been told some nonsense along the lines that their brother-in-law’s barber’s niece’s boyfriend worked as a Garda driver for the Minister of Defence, and that the army were about to start patrolling the streets and locking down the country. I refused pointblank to give more than one month of anything, and that kept things just about manageable, but it was all still pretty manic.
There will undoubtedly be ways that AI can help us to do our work as pharmacists
So five years on, what’s the legacy of the virus? We still have Healthmail, which although far from perfect, still beats the hell out of the pre-Covid medieval world of having no emailed prescriptions whatsoever. So in my book, that’s a win.
We’re still not sending the yellow bags to PCRS, which is good in one way, but finding space to store the paperwork is a challenge in itself.
The use of Zoom for education and meetings is a good way to use time efficiently. In my own pharmacy, I’ve kept the plastic screens to stop people coughing and spluttering various bugs onto me and my co-workers. The biggest change I made during Covid was closing for an hour at lunchtime. Nobody complained because we pitched it as being necessary for cleaning down
the pharmacy, and now I wouldn’t even dream of not closing for lunch. It probably leads to a few lost sales, but the benefits massively outweigh any losses. As the saying goes, never waste a crisis.
Speaking of waste, pharmacies seem to generate an almost depressing amount of plastic and paper waste. A lot of it is unavoidable due to tablets being blister-packed, and patients needing to get patient information leaflets, and that everything needs to go into bags, and to be labelled. However, there are other times when I have to wonder who is making decisions in some companies that send in boxes of medication in shrinkwrapped bundles for no apparent reason, or put large amounts of bubble-wrap in cardboard delivery boxes to ‘protect’ unbreakable smaller cardboard boxes.
Companies also insist on posting out information on new products that I have no patients currently taking, so I simply bin the material, knowing that I can look it up online if a prescription ever comes. As PCs, keyboards, screens, pricing guns, printers, and other tech get upgraded, the old versions are often still serviceable but end up being dumped to be recycled (hopefully) instead of being donated for use by schools or charities. It always seems a shame that there is not more done to reduce waste generally across the sector. ●
Fintan Moore graduated as a pharmacist in 1990 from TCD and currently runs a pharmacy in Clondalkin. His email address is: greenparkpharmacy @gmail.com
The link between veterinary medicines and illicit drug-dealing is nothing new, writes Dr Des Corrigan
The trigger for this month’s article was an alert from the US about the detection of the veterinary sedative medetomidine in street drugs, mainly but not exclusively in the fentanyl that is exercising US President Donald Trump so much.
Having written about another veterinary sedative, xylazine, in 2023, I began to wonder about a new trend. Then I remembered that the link between veterinary medicines and the illicit drug trade was nothing new, dating back as it does to the late 1990s, when ketamine emerged as a drug of abuse. Ketamine is different to the veterinary sedatives in that it is abused in its own right, whereas they, along with the anthelmintic levamisole, are used as cutting agents to enhance the profitability of street opioids, benzos, and cocaine.
Even though it is an effective anaesthetic and analgesic — at present, the Health Products Regulatory Authority (HPRA) has licensed 12 ketaminecontaining or related products, five for human and seven for veterinary use — a letter to the Editor of the Irish Journal of Medical Science last year from staff of the HSE’s National Social Inclusion Office and Drug Treatment Centre highlighted the increasingly prominent use of ketamine in Ireland as part of a repertoire of stimulant and euphoria-producing ‘club drugs’ while socialising.
The letter noted that 63 per cent of respondents to a web survey had used ‘CK’ or ‘Calvin Klein’ — a mixture of cocaine and ketamine — in the past year, with episodes of a schizophrenialike syndrome, impairment of working
memory, and haemorrhagic cystitis being reported. The SPC (Summary of Product Characteristics) for the licensed products also refers to the development of tolerance and dependence.
Seizures of ketamine by gardaí have also increased, sometimes in the form of what is called 'Tuci' or 'Tusi', or 'Pink Cocaine'. The latter rarely contains any cocaine, instead usually consisting of ketamine, MDMA, and the psychedelic stimulant 2C-B coloured pink with food dye or strawberry flavouring as a marketing ploy.
In more recent years, ketamine has been associated with ‘chemsex’, where a mix of psychoactive drugs are used to prolong sexual pleasure, used mainly by
men who have sex with men. As well as ketamine, the mix commonly contains crystal meth, mephedrone, and GHB or G. Sometimes the drugs are injected — a practice known as ‘slamsex’ — which is seen as particularly harmful due to the risk of injection-related infections and STIs. Another veterinary product is levamisole, which has been detected in cocaine samples since 2003. Here, the most recent report (2023) from the Merchant’s Quay/HSE syringe analysis project noted that 77 per cent of the 165 syringes returned to the needle exchange tested positive for levamisole. The thinking behind its use as a cutting agent is that it can boost the effects of cocaine because it is metabolised to the
amphetamine-like drug aminorex. There are no levamisole products licensed for human use, although some 11 are approved as veterinary anthelmintics. There are concerns over its ability to cause neutropaenia and agranulocytosis, as well as cutaneous vasculitis, tissue thrombosis, and necrosis of the skin.
This harmful effect on the skin links levamisole to xylazine, which is now notorious in the US for the gangrenous skin ulceration associated with exposure to it in street fentanyl and benzos. This is apparently not like other injection-related skin wounds and infections, because lifethreatening wounds are reported to occur in limbs where no injection took place, as well as in people who used non-injecting routes of administration.
Another issue is that while it causes severe respiratory depression, it does not respond to naloxone, although this should still be given, as xylazine is usually mixed with opioids. An α2-adrenoceptor antagonist such as atipamezole, tolazoline, or mirtazapine would work but none of these are currently licensed for reversal of xylazine toxicity in humans.
Xylazine or ‘Tranq’ has been mainly a problem in North America until recently, but according to a review conducted by the Advisory Committee on the Misuse of Drugs (ACMD) in the UK last year, it has been detected in nitazene samples seized in Estonia.
In fact, it is not just a cutting agent for opioids such as fentanyl, nitazenes, or heroin, but it has been found mixed with designer benzos such as bromazolam and etizolam in Canada. In the UK, xylazine has been detected in products believed by the purchaser to be benzos, THC vape liquid, codeine and tramadol tablets, heroin, and nitazenes.
The ACMD also reported 16 fatalities since 2022 in which xylazine in combination with other drugs was detected in post-mortem samples. While there is as yet no evidence of xylazine in drugs on the Irish market, it would be unwise to assume that such adulteration is not occurring, especially if the various forensic labs are not yet including it in their
analytical screens.
The most recent veterinary sedative to be detected in street drug samples in many parts of the US is also an α2adrenoceptor agonist. Medetomidine is used mainly in cats and dogs for sedation, analgesia, and as a premedication prior to anaesthesia, often with ketamine. The HPRA lists 10 licensed products, although some contain dexmedetomidine, which is the dextrorotatory isomer, with medetomidine being the racemic mixture. Dexmedetomidine itself is in six products licensed for human use in sedating adult ICU patients or those undergoing certain diagnostic or surgical procedures.
Xylazine or ‘Tranq’ has been mainly a problem in North America until recently
According to an alert from the US Centre for Forensic Science Research and Education (CFSRE) in 2024, dexmedetomidine is the active isomer with a potency some 200-to-300 times that of xylazine. It also has a longer duration of action. The CFSRE alert referred to mass outbreaks of overdoses due to fentanyl adulterated with both xylazine and medetomidine (called ‘rhinotranq’ or ‘mede’) in Philadelphia, Chicago, Toronto, and Vancouver.
Last November, the Philadelphia Department of Public Health issued an alert about atypical but severe withdrawal symptoms in drug users who required ICU levels of care. These symptoms were similar to those seen with dexmedetomidine in the hospital setting and included intractable vomiting, excessive sweating, hypertensive emergency, hypoactive encephalopathy, tremor, and profound bradycardia turning to tachycardia, all of which occurred rapidly after intoxication.
That alert also mentioned 46 deaths where medetomidine had been detected between May and November. The various SPCs draw attention to reports of reproductive toxicity, highlighting that pregnant women should not be exposed to this drug. In addition to setting out the risk of respiratory depression, the SPCs state that combination with other sedatives, hypnotics, and opioids is likely to lead to enhanced sedation and cardiorespiratory effects, so using it as a cutting agent for street forms of these drugs does not seem such a bright idea. The risk of local vasoconstriction is also mentioned, which raises the possibility of increased wound prevalence in illicit drug users similar to that reported with xylazine. Neither of the two veterinary sedatives are currently scheduled as controlled drugs, although the ACMD has recommended that the UK include xylazine under their Misuse of Drugs Act.
Notwithstanding the absence at this time of strict storage requirements, can I suggest to those pharmacists who stock xylazine or medetomidine products that they give some thought to preventing diversion of them towards street drugs. ●
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.
Terry Maguire enters the rabbit hole of mental health research
Alice descends
It started with Fergal Keane and an ‘in-depth’ article on the BBC website on a Sunday morning. It was the entrance to a rabbit hole, I knew that if I entered, I would certainly fall down and be there for some considerable time. In Fergal’s excellent piece, he opened up about his mental health challenges — a problem with alcohol, PTSD, and periods of deep depression that had him in and out of hospital over his busy and successful career. He has now achieved an accommodation with his mind following the insight that happiness is ethereal, fleeting, and hard-won. There is a need to work hard for it, he tells us. He has been doing the hard work of real happiness for some time now and is achieving it. It’s a journey, not a destination. Really loving and caring for others, appreciating the beauty of nature, and being kind to yourself is all that is needed. So why is it so difficult, asks Fergal.
He now writes a gratitude list every morning, reads more poetry, goes for long nature walks, and has started to meditate. He goes to the movies, enjoys cleaning, washing, cooking, and paying the bills — small quotidian pleasures. He has returned to a simpler life, one that is more likely to offer the happiness he seeks. Not pleasure, but happiness. Happiness is completely different to pleasure.
What Fergal is doing is fully engaging with the ‘Take 5’ campaign messages currently being promoted by the Public Health Agency in the most recent Living Well Pharmacy campaign in Northern Ireland. Pharmacies are paid to
participate actively in these campaigns. Take 5 tells us that to improve mental health we need to: Connect, exercise, give, take notice, and keep learning. The benefits in these five activities can transform your life and yet what seems so simple is, as Fergal Keane says, difficult, requiring hard work over time, and most of us just don’t want to be bothered.
In a side tunnel in this rabbit warren I meet psychotherapist Philippa Perry, wife of British artist Grayson Perry. She was interviewed in The Times of London , which I moved on to this Sunday morning from the BBC website. Philippa candidly suggested that many of her clients just needed to wise up and stop being so self-centered, negative, and selfish. She is convinced that people are more focused on their own catastrophic
thoughts without any reference to facts. They allow terrifying thoughts to occupy their minds, so it’s not surprising they suffer from poor mental health. We need to know which thoughts are unhelpful and toxic and we need to let them go, she insists. This is something that GPs neither have time or training to address when meeting patients who are seeking help. It’s unlikely too that the Living Well Pharmacy Campaign being run for two months will achieve very much.
Interestingly, The Times ' journalist tells us that the day following this interview, and before it was published, Philippa contacted them, asking if this comment could be deleted as she feared a 'woke' backlash. It wasn’t deleted and she didn’t get the backlash, and the article is much the better for it.
In the same edition of The Times , there was an article reporting that 80 per cent of UK GPs in a survey believe that everyday stresses and strains are too readily identified as mental illness. Most patients prescribed antidepressants probably didn’t need them; instead, they needed to change to be more caring and connected in their lives. However, GPs seem powerless to integrate this into patient advice.
The books section of The Times that Sunday morning featured a number of mental health self-help books and I suppose this is not unusual, given society’s need for magic bullets to improve our mental health and make our lives better.
One of the books by a young author TJ Power, a bestseller called The Dose Effect , was too tempting to ignore and I was off into another tunnel. The book, aimed at millennials and younger adults, makes the case that we need
to learn to live our lives so that our brain neurotransmitters are in optimal balance. Dopamine, oxytocin, serotonin and endorphins (DOSE) are the neurotransmitters discussed and while offering a useful explanation, this book is much too simplistic. I went down this rabbit hole for the following week and didn’t get much in return.
A much better book covering the role brain neurotransmitters play in mental health is The Molecule of More by Daniel Lieberman and Michael Long; which, of course, is about dopamine. Where dopamine focuses on maximising motivation for more of the things we like and for designing our futures, oxytocin, serotonin and endorphins are grouped together as the 'Here and Now' neurotransmitters (H&Ns). The H&Ns are the neurotransmitters that when active, make us appreciate the here and now.
Together with dopamine they create happiness. And the widely-promoted practice of mindfulness gets us to the present, where we can enjoy things. This is also where Fergal Keane had arrived with his hard work, maximising his H&N chemicals to counter and calm the wondrous, dangerous dopamine which is the core of his talent and insatiable ambition. Raging dopamine has over his life suppressed the H&N neurotransmitters, allowing him to succeed, yes, but also exhausting and depressing him and giving him a difficult relationship with alcohol and ultimately, chronic PTSD.
In the final tunnels of my Sunday rabbit hole odyssey, I came across an article on The Conversation website about Senator Robert F Kennedy Jnr (RFK Jr). RFK Jr is against the wide use of antidepressants. The article addressed a recent comment he made that it is easier to come off heroin than it is to come off antidepressants.
Weaning off the most commonly used antidepressants, the SSRIs, can be difficult, causing SSRI discontinuation syndrome. The main symptoms —
dizziness, nausea, headache, and fatigue — are viewed by many as the return of depression, and so they continue with the SSRIs.
Evidence suggests that SSRIs with short half-lives are more likely to cause SSRI discontinuation syndrome. These drugs include paroxetine and fluvoxamine, which cause discontinuation syndrome in about 7 per cent of people. Antidepressants with a long half-life — such as sertraline and fluoxetine — only cause the syndrome in about 2 per cent of people. But some studies suggest that discontinuation syndrome may be as high as 40 per cent when people stop taking SSRIs abruptly.
We fail mainly because current culture demands a diagnoseand-treat approach
The situation is further complicated in that some SSRIs, when broken down by the body, have active metabolites. These metabolites can have similar effects to the SSRI and effectively prolong the half-life of the drug. So, fluoxetine, which has quite a long halflife and an active metabolite, rarely triggers discontinuation syndrome. On the other hand, paroxetine, with a short half-life and no active metabolite, is the SSRI most likely to cause withdrawal effects, accounting for about 65 per cent of cases.
To minimise SSRI withdrawal syndrome, taper-off the dose over several weeks or months before coming off completely. Switch from a shortacting SSRI to one with a long half-life like fluoxetine, and then taper off.
More users of heroin experience withdrawal compared to users of SSRIs. Some 85 per cent who inject the drug experience severe withdrawal
symptoms when stopping. As with SSRIs, opioid withdrawal syndrome severity depends on how long they have been used for and the half-life of the specific opioid. We use methadone and buprenorphine for recovery, as they have a longer half-life.
The half-life of heroin is very short, giving severe withdrawal symptoms. However, heroin produces two active metabolites when it is broken down in the body, 6-MAM and morphine, which, like heroin, activate mu opioid receptors.
But these metabolites do not activate the mu opioid receptor to the same extent as heroin. So in most cases of heroin withdrawal, significant symptoms occur, leading to severe effects.
RFK Jr is wrong. Coming off SSRIs can be very difficult but, for most people, it is not as difficult as coming off heroin. But his core point is that we prescribe SSRIs for too many people when they can naturally enhance their mental health by doing a few simple things.
I knew it would be a long journey when I entered that rabbit hole and when I finally emerged about three weeks later, rubbing my eyes and feeling like Alice, I had a much better appreciation of the mistakes we are making in mental health policy and treatment. We fail mainly because current culture demands a diagnose-and-treat approach. This is not what is required and is likely making things worse. It is difficult to live our lives differently given the Western capitalist culture we are embedded in, but to embrace happiness we really need to support greater harmony with our key neurotransmitters, just as Fergal Keane eventually learned to do. ●
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.
Technology is there to enhance our practice, and these advancements should also apply to the PSI elections, writes Áine Mac Grory
The more I bring up progress and innovation, the more I realise what a large cohort of my professional counterparts consider the use of AI technologies like ChatGPT with the same level of disdain as someone googling answers at a pub table quiz. ‘Bad’, ‘cheating’, ‘lazy’.
A colleague of mine, Leon O’Hagan, recently won the IIOP competition on the future of pharmacy. He wrote an article with the help of AI by providing prompts to encourage it to think of current and developing technologies in pharmacy and pharmaceutical care.
At first, ‘pub quiz cheater’ was my knee-jerk reaction, but a light-bulb moment hit me when he said, “Just because you have access to a Ferrari doesn’t mean you can drive it!”
His work inspired me to experiment with my own AI method (and, of course, I sought permission from the Editor.)
I so badly want this outlook to be reframed and embraced with a proactive drive to consider all the amazing things that can be achieved from this technology.
The potential for administrative tasks to be considerably reduced, or dare I say abolished altogether, freeing-up community pharmacists to have time for a lunch break — imagine.
To have time to go out to each patient that needs that extra bit of counselling.
To have time to make meaningful, impactful engagements with the most vulnerable cohorts — the ones who are the walking definition of the inverse care law.
There is so much scope for the community pharmacist to tackle this, if given the supports required to do it.
During the intro of The Diary of A CEO with Steven Bartlett, episode from 17 March, the host does a piece about
subscribing and following. It gave me pause.
The effort they go to, to implore THEIR FANS to tap a button on a phone, is extraordinary.
Similarly, in the context of the current PSI elections, which are conducted via paper ballots, there is a parallel in the way participation — through voting — shapes the outcome of an institution.
Casting your vote directly impacts leadership in pharmacy and policy direction.
Less than 20 per cent of the total electorate (the number of pharmacists registered with the PSI) voted in the last PSI council election.
If you haven’t heard already, I put my hat in the ring this year, and of course, I would be thrilled to be elected, but what I would really like to see is more voters and more interest in who you are choosing as your council members.
In the absence of a reason to change, the ‘safest’ option is to not change.
The existing sector is becoming less relevant to every new cohort of
pharmacists graduating and registering, and if we keep doing what we’ve always done, we will get more of the same.
If anything in this article resonates with you and you are one of the 80 per cent that didn’t vote, I urge you to consider voting this time.
I can assure you that I will push for this to be the last time you have to do it via this method.
This election isn't just a formality.
The PSI Council is responsible for guiding the PSI in ensuring safe pharmacy services, patient safety, and public trust in the pharmacy profession. They decide how we work, what services we can deliver, and how much of an impact we can really have in our communities.
The PSI Corporate Strategy 2025–2028 outlines three core objectives.
Objective 1: Regulating pharmacists and pharmacies to deliver essential and expanded services safely. This is our bread and butter, our role on the frontlines. Voting for PSI Council members means selecting the voices that will represent us when it comes to guiding policy, enabling new services, and protecting our practice.
Objective 2: Evolving the regulatory approach to enhance patient safety outcomes. This isn’t just a line on a page — this is the day-to-day impact we can have if we’re supported and empowered through clear, meaningful regulation.
Objective 3: Enhancing and aligning the PSI organisation and its people to successfully achieve these strategic goals. None of these objectives can happen in a vacuum. They rely on a strong, focused Council who understand the pharmacy landscape from the ground up.
And that Council is chosen by you.
This potential of the future for
pharmacy is in jeopardy if pharmacists do not take part in the election process. We are the ones who decide our trajectory — our progress depends on participation.
Contrary to popular opinion (or workforce intelligence reports), I don’t believe the administrative burden itself is the problem.
The biggest culprit for delaying and affecting my work is INTERRUPTION.
It’s clangs, clatters, and clashes. It’s computer screens crashing, wires fraying — nerves too, as a result.
It’s the ‘can I just ask you something’s. It’s pop-up boxes, signing in and out, ticking the box to say you are the pharmacist on-site even though I already
*we can all agree on. How do we get it? We generate attention. How? By getting heard. Correctly. Reaching as many people as possible using every resource available to us: Letters, magazines, emails, WhatsApp, Telegram, Facebook, TikTok, YouTube, podcasts, mass followings, influencers, positive controversy. This is a lot of work — if only we had access to specialised services to help with it...
In the dispensary, where possible, I streamline all calls to a WhatsApp phone to reduce incessant ringing. The landline is for the three outliers who truly do not have smartphones or the capacity to text.
An occasion arose for my retail assistant
We need adequate communication methods and modernised equipment and technology to allow us to engage with our patients better
signed in and out, then more pop-up boxes and repetition of tasks.
Did I mention signing in and out?
It’s label reels ending mid-dispense, typos form rushing, jammed OKI printers, and ridiculous unnecessary steps like FMD scanning at the point of dispensing.
Spoiler alert: This is not because it is EU legislation, and we have no choice.
Ask a hospital pharmacist what FMD procedure they follow if you don’t believe me, or @ me on Insta and we can talk.
As I said recently at a forum on this topic, reverse FEMPI to start, and give me a €50k Annual Administration Appreciation Allocation?
Yeah, I’ll do all the administration work you want. Well, I won’t personally, of course.
What I mean to say is, I could afford an in-house administrative consultant to do it for me and remove myself and the dispensary team from any of its involvement.
How do we fix it? MONEY.
That is possibly the only thing
to call one of the three, and there was a pause… the coyness was tactile.
"Sorry… I have just never used one of these before and I don’t know how to use the search function." She was referencing the old ABC vs 123 button presses.
Well. That humbled me. Wireless phones were a top-tier advancement at one point in my life.
Now we have gone further again, and we can stick an Air Pod in and operate completely hands-free. We can cancel noise! Imagine!
I am concerned that what will happen is an upgrade from wires to wireless phones with a cheer of success when, in fact, by the time that is implemented, everyone else has their AirPods in.
We need adequate communication methods and modernised equipment and technology to allow us to engage with our patients better. It would be encouraging to see the people in leadership embracing these tools, allowing their teams to prepare for the pending influx of pharmacists registering soon.
I want to see ourselves as a unified, forward-thinking, and passionate workforce. I want to see technology leveraged correctly to ensure time is freedup for more meaningful work.
I want to see pharmacists no longer bogged down by unnecessary admin, instead focusing on patient care and innovation.
AI is here, whether it is welcome or not, and it must be incorporated into the aims of the PSI strategy 2025-2028 for it to be executed properly. It will serve to benefit everyone and, most importantly, the patients.
To use the phrase ‘happy wife, happy life’, consider pharmacists the wives and patients the lives.
And that’s what it’s all about. Our patients (and ironically, our patience). ●
*We – that’s an article for another day.
In the interest of transparency, this article was produced with the use of several different AI tools. To name a few, the Copilot feature on Microsoft Word and ChatGPT. I look forward to this being a given, like announcing you used excel to populate data or the spell-check feature for an essay submission. I used an AI dictator tool to transcribe and format the transcript from the podcast intro I mentioned above and asked ChatGPT to draft a paragraph that considers the message of this man’s speech with reference to the current PSI elections being paper ballots.
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.
A number of factors can contribute to the development of a migraine. Migraine is often confused with a ‘regular’ headache and can be debilitating if severe. On completion of this module, it is expected the reader will have an enhanced understanding of the pathophysiology of migraine, potential triggers, and management, including the right use of appropriate medications.
AUTHOR: Damien O'Brien MPSI
You can check your answers to the T/F and MCQ questions on PharmacistCPD.ie
Successful completion of this module will earn you 2 CPD points
Migraine is a complex neurological disorder characterised by moderate-to-severe headaches that are often accompanied by nausea, photophobia and phonophobia. Migraine attacks typically last for hours to days and are associated with a reduced ability to function, which worsens with physical activity. They can significantly impact daily activities and reduce the quality of life for individuals. Migraine attacks are both recurrent and complex neurological events. Migraine is a prevalent condition worldwide, affecting approximately 12 per cent of the population. It is approximately three times more
prevalent in females than males, with up to 17 per cent of females and 6 per cent of males affected annually. It tends to peak between the ages of 35 and 39 and decreases later in life, especially after menopause.
Community pharmacists play an important role in managing this complex condition. Pharmacists counsel patients on the proper use of medication and the importance of adherence. They can also educate patients on lifestyle modifications and warning signs that require referral while collaborating with other healthcare professionals.1
The pathophysiology of migraine is not fully understood, but is thought to involve a combination of genetic, vascular and neurological factors. The pathophysiology is very complex, but understanding it is important for effective diagnosis and treatment. Migraine has a very strong genetic component, although a specific inheritance pattern hasn’t been fully identified. The risk of migraine in an individual with a close family relative who has migraine is three times greater than in an unaffected individual. However, the genetic basis of migraine is still not fully known and involves multiple genes and loci. 1
The pathophysiology of migraine
involves complex interactions between the peripheral and central nervous systems. One key mechanism is cortical spreading depression, which is a wave of neuronal depolarisation followed by inhibition that spreads across the brain. This is considered responsible for the aura phase of migraine, triggering subsequent changes in brain activity.
The activation of the trigeminovascular system plays an important role in migraine pathogenesis. This involves the trigeminal nerve, which releases vasoactive neuropeptides like substance P, calcitonin gene-related peptide (CGRP) and neurokinins. These neuropeptides contribute to neurogenic inflammation, vasodilation and increased pain sensitivity. CGRP is a key mediator in migraine, with elevated levels observed in individuals with chronic migraine. Neurogenic inflammation can lead to central sensitisation, a process in which neurons become more responsive to stimuli and potentially contribute to the transition from episodic to chronic migraine. Additionally, serotonin is thought to play a role in migraine pathophysiology. Reduced serotonin levels are associated with migraine onset, and serotonin modulates pain pathways and may influence headache severity. 1
Migraine is a chronic neurological disorder that is characterised by recurrent moderate-to-severe headaches. These headaches are typically unilateral, with a pulsating or throbbing nature. They are generally worsened by physical activity and may be accompanied by nausea, vomiting, and sensitivity to light and sound.
Migraine attacks tend to last for four-to-72 hours and may include aura, which is a series of neurological disturbances (visual changes, sensory symptoms or speech difficulties) that precedes or accompanies the headache. Migraine attacks generally progress through four main phases, each with distinct features.
Prodrome: Premonitory symptoms experienced for up to 48 hours before the onset of a migraine. Common symptoms include yawning, lethargy, mood changes, photophobia, phonophobia and restlessness.
Aura: The aura phase may precede the headache or present simultaneously. They are typically gradual and fully reversible, lasting for up to 60 minutes. Visual auras are the most common, though sensory, motor and language auras are also possible.
Headache: The headache phase typically lasts four-to-72 hours, often increasing in intensity within the first few hours. The pulsating pain may be accompanied by nausea, vomiting, photophobia and phonophobia.
Postdrome: This phase involves symptoms that persist after the headache phase. Movement may cause pain in the location of the headache, with other symptoms including exhaustion and difficulty concentrating.1
Exposure to or withdrawal from various factors can contribute to the onset of migraine. Migraine triggers vary widely among individuals, with many reporting identifiable trigger factors. Some trigger factors are probable contributors, while others are possible or unproven. Some potential trigger factors are listed below:
Q1. Migraine is equally prevalent in males and females.
True or false?
Q2. The risk of developing migraine is not influenced by genetic factors.
True or false?
Q3. Unilateral pain is more common than bilateral pain in migraine.
True or false?
Q4. Migraine with aura is the most common type of migraine, accounting for approximately 70% of cases.
True or false?
Q5. A migraine diary can help identify potential triggers and evaluate the effectiveness of treatments.
True or false?
Q6. Triptans are used to treat mild migraine attacks and should be taken
Generalised stress.
Hormonal changes.
Missed meals.
Caffeine - excessive intake or abrupt withdrawal.
Irregular sleep patterns.
Medications.
Alcohol.
Odours.
Physical exertion.
Weather changes.
Medication overuse.1,2
The diagnosis of migraine is based on the patient’s history, a physical examination, and the application of diagnostic criteria. The International Classification of Headache Disorders
during the aura phase.
True or false?
Q7. Opioids are recommended for the acute treatment of migraine due to their high efficacy.
True or false?
Q8. Antiemetics, such as metoclopramide, help manage nausea and gastric stasis in migraine patients.
True or false?
Q9. Prophylactic migraine treatment is recommended for individuals experiencing four or more migraine attacks per month.
True or false?
Q10. CGRP antagonists, such as erenumab and fremanezumab, are designed specifically for acute migraine treatment.
True or false?
( ICHD-3 ) has developed criteria for diagnosis. It is complex but structured, and is based on the symptoms a patient may have. Accurately diagnosing migraine involves distinguishing it from other types of headaches and neurological conditions. Differential diagnosis must consider factors and symptoms that overlap with other disorders, including tensiontype headache, cluster headache, cerebral aneurysms, encephalitis, intracranial haemorrhage, and meningitis. Neuroimaging, such as computed tomography (CT) scans or magnetic resonance imaging (MRI), may be necessary if secondary causes,
including brain tumour, meningitis or stroke, are suspected. 1
The ICHD-3 classifies migraines into several subtypes:
Migraine without aura is the most prevalent type of migraine, accounting for approximately 70 per cent of migraines. It involves recurrent headache attacks lasting four-to-72 hours without the neurological symptoms associated with aura.
Migraine with aura is characterised by fully reversible neurological symptoms lasting up to 60 minutes. It is estimated that 25 per cent of migraines involve aura.
Chronic migraine is defined as a headache on at least 15 days per month, with features of migraine present on at least eight days. Chronic migraine is highly debilitating and significantly reduces quality of life.
Probable migraine presents with migraine-like symptoms but lacks one of the features required to meet the diagnostic criteria for migraine and does not meet the criteria for another type of headache. 1
Non-pharmacological treatment is an important aspect of migraine management. These approaches can be used alongside pharmacological treatments. They are particularly useful when other treatment options fail or are contraindicated, which can be important in specific patient groups such as pregnant women or adolescents. These methods generally offer an excellent safety profile when practised correctly. 3
There are several lifestyle modifications that may help patients with migraine. Many trigger factors can precipitate a migraine attack; therefore, identifying and limiting exposure to these factors is an important aspect of the non-pharmacological management of migraines. Furthermore, patients may feel a sense of control over their condition by being aware of potential
triggers. Individuals should aim to maintain a regular sleep pattern, balanced diet, adequate hydration, regular exercise, a consistent meal schedule, limit caffeine intake, smoking cessation, and limit alcohol intake. 3
A migraine diary is a simple but effective method of managing migraine. It can help individuals establish certain patterns or identify specific triggers of migraine attacks. The diary should be maintained systematically over time to identify migraine patterns and facilitate effective management. Close attention should be paid to environmental, lifestyle and dietary factors in the hours and days before a migraine attack. Additionally, the diary allows an individual to monitor the success or failure of treatment. 3
Stress management techniques , including cognitive behavioural therapy, relaxation techniques and meditation, may be effective in migraine prevention. Generalised stress is one of the most common trigger factors; therefore, reducing stress can help decrease migraine frequency.
Acupuncture is an alternative therapy that may benefit individuals with episodic migraine. When performed by a trained practitioner, acupuncture is safe and associated with a low incidence of adverse effects.
Dietary supplements may also have effectiveness in the management of migraine. Riboflavin (400mg daily), coenzyme Q10 (300mg daily) and magnesium (400-600mg daily) may serve as preventive measures against migraine. Evidence suggests they may be effective in managing migraine, particularly chronic migraine. These supplements are typically well-tolerated and are associated with a low incidence of adverse effects. However, more research is needed on the efficacy and safety of these supplements, including their interaction with other medications.
Botulinum toxin A injections have been proven effective in treating chronic migraines and are established as a welltolerated prophylactic treatment option
when other pharmacological methods have failed. 3,4
The pharmacological treatment of migraine involves a multifaceted approach aimed at alleviating symptoms, preventing attacks, and improving patients' quality of life. Pharmacological management includes both acute and preventive treatment approaches. Effective management requires both acute treatments to relieve symptoms during a migraine attack, and prophylactic strategies to reduce the frequency and severity of attacks.1,5
Acute pharmacological therapy aims to relieve the pain and associated symptoms during the headache phase of migraine. Treatment should typically be initiated as soon as possible during this phase. The response to treatment may vary considerably between patients. A stepwise approach to treatment should be followed to achieve the safest and most effective therapy; combination therapy may also be considered. 5
Nonsteroidal antiinflammatory drugs (NSAIDs) NSAIDs are first-line acute treatment for mild-to-moderate migraine attacks. They work by blocking the cyclooxygenase enzymes. This inhibits the synthesis of prostaglandins, which are mediators involved in inflammation and pain. NSAIDs are available over the counter (aspirin and ibuprofen) or on prescription (celecoxib, etoricoxib, diclofenac, meloxicam, naproxen, dexketoprofen and mefenamic acid).
If an NSAID is ineffective, switching to another drug class or using an NSAID as part of combination therapy may be considered. A significant proportion of patients with acute migraine may experience nausea and vomiting, which can prevent them from tolerating oral tablets. Diclofenac suppositories may be considered to
The only oral once-daily calcitonin gene-related peptide (CGRP) receptor antagonist for both episodic and chronic migraine patients1,2
Tablet not actual size.
Typical characteristics of migraine are headache of unilateral location, pulsating quality, moderate or severe intensity, aggravation by routine physical activity and association with nausea and/or photophobia and phonophobia.3
ABBREVIATED PRESCRIBING INFORMATION. AQUIPTA® (atogepant) 10 mg tablets; 60 mg tablets. Please refer to the Summary of Product Characteristics (SmPC) before prescribing. PRESENTATION: Each tablet contains: 10 mg atogepant in 10 mg tablet, 60 mg atogepant in 60 mg tablet. INDICATION: Prophylaxis of migraine in adults who have at least 4 migraine days per month. DOSAGE AND ADMINISTRATION: The recommended dose is 60 mg taken orally once daily with or without meals; swallowed whole and not split, crushed or chewed. Missed dose to be taken as soon as it isremembered. If forgotten for an entire day, missed dose to be skipped and next dose taken as scheduled. Dose Modification: The recommended dosage of atogepant with concomitant use of strong CYP3A4 inhibitors or strong OATP inhibitors is 10 mg once daily. Special Populations: Elderly: No dose adjustment needed. Renal impairment: In patients with severe renal impairment (creatinine clearance [CLcr] 15-29 mL/min), and in patients with end-stage renal disease (ESRD) (CLcr <15 mL/min), the recommended dose is 10 mg once daily. For patients with ESRD undergoing intermittent dialysis, atogepant should preferably be taken after dialysis. No dose adjustment is recommended for patients with mild or moderate renal impairment. Hepatic impairment: Avoid use of atogepant in patients with severe hepatic impairment. No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Paediatric Population: The safety and efficacy of atogepant in children (< 18 years of age) have not yet been established. CONTRAINDICATIONS: Hypersensitivity to active substance or any of the excipients. SPECIAL WARNINGS AND PRECAUTIONS: Serious hypersensitivity reactions reported, including anaphylaxis, dyspnoea, rash, pruritus, urticaria and facial oedema. Most serious reactions have occurred within 24 hours of first use, however, some hypersensitivity reactions can occur days after administration. Patients should be warned about symptoms of hypersensitivity. If a reaction occurs, discontinue atogepant and institute appropriate therapy. AQUIPTA 60 mg tablets contain 31.5 mg sodium per tablet; this is equivalent to 1.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult. AQUIPTA 10 mg tablets contain less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree’. Atogepant has no or negligible influence on the ability to drive and use machines. However, if affected by somnolence, patients should exercise caution before driving or using machinery. FERTILITY, PREGNANCY
AND LACTATION: Pregnancy: Atogepant is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding: It is unknown whether atogepant is excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility: No human data on the effect of atogepant on fertility are available. Animal studies showed no impact on female and male fertility with atogepant treatment. UNDESIRABLE EFFECTS: Common (≥ 1/100 to < 1/10): Decreased appetite, nausea, constipation, fatigue/somnolence, weight decreased. Refer to Section 4.8 of the SmPC for details of other side effects, and for further information.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; website: www.hpra.ie.
LEGAL CATEGORY: POM (S1B). MARKETING AUTHORISATION NUMBERS: EU/1/23/1750/001 AQUIPTA 10 mg tablets in blisters, in cartons of 28 tablets; EU/1/23/1750/003 AQUIPTA 60 mg tablets in blisters, in cartons of 28 tablets.
MARKETING AUTHORISATION HOLDER: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany. Further information is available on request from: AbbVie Limited, 14 Riverwalk, Citywest Business Campus, Dublin 24. DATE OF REVISION: November 2024. PI/1750/002.
References: 1. AQUIPTA® Summary of Product Characteristics, available at www.medicines.ie. 2. Morena-Ajona D, et al. J Clin Med. 2022;11(6):1656. 3. Ferrari MD, et al. Nat Rev Dis Primers. 2022;8(1):2.
IE-AQP-250001 | Date of preparation: January 2025
ensure the medication enters systemic circulation. The adverse effects of NSAIDs include gastrointestinal discomfort, gastrointestinal bleeding, hepatotoxicity, reduced kidney function, hypertension, and thromboembolic events.1,5,6
Paracetamol
Paracetamol is an option for the acute treatment of migraine. Although it is not as effective as NSAIDs, it can be useful when NSAIDs are not tolerated or are contraindicated. It is available over the counter in Ireland. It has an excellent safety profile when used correctly and is particularly useful for treating migraines in certain populations, such as adolescents and pregnant women. 5
Triptans are effective in the acute treatment of moderate-to-severe migraine and menstrual migraine. Sumatriptan, zolmitriptan, eletriptan, naratriptan, rizatriptan, frovatriptan, and almotriptan are licensed for the treatment of migraine, but they tend to be more expensive than NSAIDs. Triptans are pharmacologically specific for acute migraine treatment and can be used as monotherapy or in combination with other acute treatment options. Unlike NSAIDs, patients who do not respond to one triptan may respond to another, necessitating individualised treatment.
Triptans are serotonin-receptor agonists with affinity for the 5-HT1B and 5-HT1D receptors. The agonism of 5-HT1B receptors on the smooth muscle cells of blood vessels causes vasoconstriction of dilated blood vessels, thereby reducing the pulsating or throbbing pain. Agonism of 5-HT1D receptors on the trigeminal nerve prevents the release of vasoactive neuropeptides, such as CGRP, substance P and neurokinins.1,5,7 Triptans should be administered at the onset of the headache phase rather than during the aura phase.
If the first dose of a triptan relieves symptoms but the headache returns, the dose can be repeated after two hours. Similarly, if there is a partial response to the first dose, the dose can be repeated after two hours.
Sumatriptan 50mg tablets are now licensed as a pharmacy-only medicine for acute treatment of migraine when a diagnosis of migraine has been previously made by a physician. This ensures timely access to healthcare while reducing the burden on the healthcare system.
A pharmacist carries out a structured consultation with the patient, considering cardiovascular risk and medication overuse headache. Triptans
domperidone, metoclopramide, and prochlorperazine, enhance gastrointestinal motility, promoting gastric emptying and improving the absorption of acute migraine treatments. These medications provide a dual benefit by alleviating nausea and vomiting while also counteracting gastric stasis, even in patients without nausea and vomiting.
Parenteral formulations of antiemetics may be preferred for patients unable to tolerate oral medications. Metoclopramide, a benzamide, acts as a dopamine D₂ receptor antagonist at lower doses and also inhibits serotonin (5-HT₃) receptors at higher doses. Prochlorperazine and chlorpromazine primarily block D₂
Triptans are effective in the acute treatment of moderate-to-severe migraine and menstrual migraine
are generally well tolerated. Common adverse effects include pressure in the chest, throat and jaw, fatigue, myalgia, flushing, paraesthesia and dizziness. Triptans should be avoided in patients with uncontrolled hypertension, ischaemic heart disease, and cerebrovascular conditions. Patients taking serotonergic medications concurrently should be monitored for the risk of serotonin syndrome. 5,7,8
Antiemetics are often required for the acute treatment of migraine, particularly in moderate-to-severe cases where nausea and vomiting are present. They are also beneficial in managing migraine-induced gastric stasis, a condition characterised by delayed gastric emptying and reduced peristalsis, causing stomach contents to remain in the stomach longer instead of passing into the duodenum. This delay can impair the absorption and effectiveness of orally administered migraine medications. Prokinetic agents, such as
receptors, providing both antiemetic and migraine-relieving effects. However, most antiemetics used in migraine treatment carry a risk of QT interval prolongation and the development of torsades de pointes Additionally, dopamine antagonists like metoclopramide, prochlorperazine and chlorpromazine may cause extrapyramidal side-effects, such as dystonia, tardive dyskinesia, and akathisia.5,7
Opioids are not recommended for the acute treatment of migraine due to their limited efficacy, lack of migraine specificity, risk of adverse effects, and risk of medication overuse headaches. Opioids are associated with numerous adverse effects, including constipation, respiratory depression, and the potential for dependence, abuse and tolerance. Medication overuse headache develops and worsens with the frequent use of acute migraine treatments. This occurs due to sensitisation of the central nervous system. Opioids carry a high
risk of medication overuse headache and should therefore be avoided. The use of acute migraine treatments, including NSAIDs and triptans, should be limited to a maximum of two days per week to reduce this risk. This can limit the effectiveness of prophylactic treatment, and many patients with chronic migraine experience associated medication overuse headache. 5,9
Prophylactic pharmacological treatment may be offered to patients whose quality of life remains impaired despite acute treatment. Preventive treatment is indicated in two main cases: (i) when an individual experiences four or more migraine attacks per month, or (ii) when migraine attacks last longer than 12 hours. The primary objectives of treatment are to achieve at least a 50 per cent reduction in headache days or a 50 per cent reduction in the disability associated with attacks.
The selection of prophylactic therapy should be evidence-based, considering safety, efficacy and comorbidities. Titrating slowly to the maximum effective tolerated dose for a minimum of three months is recommended before deciding on effectiveness. If there is no improvement after three months at the maximum tolerated dose, the treatment may be considered a failure, and alternative options should be explored. A migraine diary is useful in this regard.
Gradual withdrawal may be considered after six-to-12 months of effective treatment to evaluate the necessity of ongoing therapy. 5
Propranolol
Propranolol is a non-selective betaadrenergic receptor antagonist that is first-line treatment for migraine preventive therapy. It is also used to treat hypertension, angina, essential tremor and anxiety. It is recommended to start at 80mg once daily in a prolongedrelease formulation, increasing up to 160mg daily. Higher doses are unlikely to provide additional benefit and carry a
Q1. Which type of migraine is the most prevalent, accounting for approximately 70% of cases?
a) Migraine with aura
b) Chronic migraine
c) Migraine without aura
d) Probable migraine
Q2. What percentage of the global population is affected by migraines?
a) 6%
b) 12%
greater risk of adverse effects.
c) 18%
d) 24%
Q3. Which class of medication is considered a first-line acute treatment for mild-to-moderate migraine attacks?
a) Opioids
b) NSAIDs
c) Beta-blockers
d) CGRP inhibitors
Q4. Triptans should be
Propranolol can be particularly useful when anxiety is a comorbid condition. Common adverse effects include nausea, gastrointestinal pain, constipation, and hypotension. It is contraindicated in patients with asthma due to its nonselective antagonism of beta-2 receptors in the lungs. 5,10
Amitriptyline is a tricyclic antidepressant licensed to treat multiple conditions and is effective for migraine prophylaxis. It is also used to treat major depressive disorder, neuropathic pain, chronic tension-type headache, and nocturnal enuresis in children. It works by blocking the reuptake of both serotonin and noradrenaline, thereby increasing noradrenergic and serotonergic neurotransmission. It is initiated at 10mg at night and increased weekly up to a maximum of 100mg daily. It may be particularly useful for patients who also suffer from insomnia.
Common adverse effects of amitriptyline include dry mouth,
taken at which phase of a migraine attack?
a) Prodrome
b) Aura
c) Headache
d) Postdrome
Q5. Which of the following medications is NOT commonly used for migraine prophylaxis?
a) Sumatriptan
b) Topiramate
c) Propranolol
d) Amitriptyline
drowsiness, dizziness, constipation and weight gain. Rarer but more serious adverse effects include hepatotoxicity, abnormal heart rhythm, glaucoma and serotonin syndrome. 5,11
Topiramate is an anticonvulsant that serves as a first-line prophylactic treatment option for migraine. It works by increasing GABA activity and inhibiting glutamate activity, blocking neuronal excitability and thereby preventing seizures and migraines.
Topiramate also inhibits the release of CGRP and glutamate from trigeminal neurovascular nerve endings. The starting dose is 25mg once daily, titrating up to 50-to-100mg daily.
Common adverse effects of this drug include tingling, fatigue, gastrointestinal pain, loss of appetite, weight loss, and decreased cognitive function.
Topiramate is also associated with a risk of teratogenicity, which should be carefully considered.
Sodium valproate is another anticonvulsant that may be used in rare
cases, though its use is limited due to safety concerns. A pregnancy prevention programme must be implemented for women of childbearing potential due to its teratogenic nature. 5,12
Candesartan is an angiotensin receptor blocker traditionally used to treat hypertension and heart failure, but it has also been used for migraine prevention in recent years. It works by blocking the angiotensin II receptor. The use of candesartan for migraine prevention is considered off-label, differing from its licensed indications in the summary of product characteristics. It is typically administered at a daily dose of 16mg, which can be split into 8mg twice daily. Candesartan is particularly useful in patients with hypertension as a comorbid condition. It is a relatively welltolerated drug, with the adverse effects including hypotension, abnormal renal function, and hyperkalaemia. 5,13
Calcitonin gene-related peptide (CGRP) antagonists
CGRP antagonists are the only class of migraine prophylactic treatments developed specifically for migraines, unlike other treatments developed for different indications. CGRP is fundamental in the pathophysiology of a migraine attack, mediating vasodilation and neurogenic inflammation. These medications target CGRP or its receptor, leading to long-term blockade and serving as an effective method of migraine prophylaxis. This class of medication is effective as preventive treatment and may have fewer adverse effects.
There are two classes of CGRP inhibitors: Injectable monoclonal antibodies (mAbs) against the CGRP receptor, and oral CGRP receptor antagonists (gepants). These drugs are indicated for individuals with more than four migraine days per month when at least three prophylactic drug treatments have failed. 7,14 Erenumab, fremanezumab and
galcanezumab are mAbs licensed for monthly subcutaneous injection for migraine prophylaxis. They are supplied through the High-Tech scheme in Ireland and prescribed under the care of a consultant. Clinical benefits may be observed within a few weeks. Eptinezumab is administered as a quarterly intravenous infusion in a hospital setting. They are generally well-tolerated, with possible adverse effects including injection site reactions, hypersensitivity and gastrointestinal discomfort. 7,14
Gepants are small-molecule CGRP receptor antagonists administered orally. They are effective in both the acute and prophylactic treatment of migraine, with rimegepant and atogepant as examples. Rimegepant is administered once daily as required for acute treatment, indicated when at least two triptans have failed or are contraindicated, and NSAIDs have been ineffective. It is also indicated for migraine prophylaxis on an alternate-day dosing schedule for patients experiencing four or more migraine attacks per month when at least three prophylactic treatments
1. Pescador Ruschel MA, and De Jesus O (2024). Migraine headache. [online] PubMed.
2. Martinelli D, Pocora MM, De Icco R, Putortì A, and Tassorelli C (2022). Triggers of migraine: where do we stand? Current Opinion in Neurology, 35(3), pp.360–366.
3. Haghdoost F, and Togha M (2022). Migraine management: Non-pharmacological points for patients and health care professionals. Open Medicine , [online] 17(1), pp.1869–1882.
4. Becker WJ (2020). Botulinum Toxin in the Treatment of Headache. Toxins , 12(12), p.803.
have failed. Adverse effects of gepants include nausea, weight loss, fatigue, and hypersensitivity. 7,14
Pharmacists play a crucial role in the management of migraines by providing patient education, optimising treatment regimens, and promoting medication adherence. Pharmacists are accessible healthcare professionals and can help patients identify potential migraine triggers and provide counselling on lifestyle modifications that may reduce attack frequency.
Pharmacists can advise on the appropriate use of over-the-counter medications to treat migraines. Furthermore, they can provide counselling on medication regimens to improve efficacy, minimise adverse effects, enhance medication adherence, and prevent medication overuse headache. In conclusion, a pharmacist’s role in patient counselling, medication management and collaboration with other healthcare professionals makes them integral to improving clinical outcomes and enhancing patients' quality of life. ●
6. Pardutz A, and Schoenen J (2010). NSAIDs in the Acute Treatment of Migraine: A Review of Clinical and Experimental Data. Pharmaceuticals, [online] 3(6), pp.1966–1987.
7. Lew C, and Punnapuzha S (2023). Migraine Medications. [online] PubMed.
8. Pharmaceutical Society of Ireland (2025). Guidance for Pharmacists on the Safe Supply of Sumatriptan 50mg Tablets | PSI. [online].
5. Mayans L, Walling A (2018). Acute Migraine Headache: Treatment Strategies. American family Physician, [online] 97(4).
10. Shahrokhi M, and Gupta V (2023). Propranolol. [online] PubMed.
11. Amit Thour and Raman Marwaha (2023). Amitriptyline. [online] Nih.gov.
12. Fariba K, and Saadabadi A (2020). Topiramate. [online] PubMed.
13. Bulsara KG, and Makaryus AN (2020). Candesartan. [online] PubMed.
9. Casucci G, and Cevoli S (2013). Controversies in migraine treatment: Opioids should be avoided. Neurological Sciences , 34(S1), pp.125–128.
14. Rashid A, and Manghi A (2022). Calcitonin GeneRelated Peptide Receptor. [online] PubMed.
One-A-Day
Abbreviated
Abbreviated prescribing information
Product Name: Fexo Allergy Relief 120 mg Film-coated tablets
Product Name: Fexo Allergy Relief 120 mg Film-coated tablets
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
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 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 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 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 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 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 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 Abbreviated
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
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
Date of preparation: (02/2025) CCF: 26995
Date of preparation: (02/2025) CCF: 26995
of preparation: (02/2025) CCF: 26995
Supply status: Supply through pharmacies only
Supply status: Supply through pharmacies only
Supply status: Supply through pharmacies only
Allergic rhinitis (AR) is an atopic disease characterised by symptoms of sneezing, nasal congestion, rhinorrhoea, itching, and postnasal drip. AR is an inflammatory condition of the nasal mucosa that can range from mild nasal congestion, to severe allergic responses.
It can be classified into seasonal allergic rhinitis and perennial allergic rhinitis. Seasonal allergic rhinitis, also known as hay fever, is triggered by pollen and is particularly common during spring and summer. Perennial allergic rhinitis is present all year and may be triggered by exposure to allergens such as dust mites, animal dander, and mold spores. Pharmacists are often the first point of contact for patients with AR, and they play an important role in providing advice on both pharmacological and nonpharmacological treatment options.
The prevalence of AR based on clinical diagnosis is approximately 15 per cent, but it may be double that based on patients experiencing symptoms. AR was previously thought to be a condition of the nasal passage, but it is now considered a systemic allergic response and is associated with conditions such as atopic dermatitis and asthma.
Symptoms can vary widely in severity and may be classified into nasal, ocular and systemic symptoms. Nasal symptoms may include sneezing, congestion, rhinorrhoea, itching and postnasal drip. Ocular symptoms include itchy, watery and red eyes, with associated allergic conjunctivitis also possible. Fatigue and headache may also be present as systemic symptoms. AR is associated with significant morbidity, reduced productivity, and increased healthcare costs. Poorly-
Damien O’Brien MPSI provides a clinical overview of assessment and treatment for allergic rhinitis
AR is caused by an immune-mediated response to environmental allergens. When an individual is exposed to an inhaled allergen, the immune system reacts, triggering a cascade of immune reactions. Firstly, the sensitisation phase occurs upon first exposure to an allergen, leading to production of allergen-specific IgE antibodies by B cells and inflammation in
such as histamine, leukotrienes, and prostaglandins. These mediators, particularly histamine, play a key role in AR, causing symptoms such as nasal congestion, sneezing and rhinorrhoea.
The late-phase reaction occurs fourto-six hours after the initial response, during which inflammatory cells such as eosinophils, basophils and T cells
are released. This leads to persistent inflammation and prolonged symptoms.1 Several risk factors contribute to the development of AR. There is a genetic predisposition to AR, with a family history increasing the risk. Furthermore, a personal history of asthma or eczema also raises the likelihood of developing AR. Exposure to environmental allergens and pollutants may contribute to AR or exacerbate symptoms. Lifestyle factors, including smoking, poor air quality and urban living, may also play a role in symptom severity.1,2
The diagnosis of allergic rhinitis is typically clinical, based on a thorough history-taking and physical examination. History-taking should focus on the type, timing, duration and frequency of symptoms, as well as suspected triggers, exacerbating factors, alleviating factors, and seasonality. A positive response to treatment can support the diagnosis. A formal diagnosis may be made using serum testing for allergen-specific IgE or allergy skin testing, but this is usually reserved for patients who are unresponsive to empirical treatment or those who require identification of a specific allergen for targeted treatment. Testing should be carried out during the peak symptom season in patients with seasonal AR.1
Pharmacological treatment plays a crucial role in the management of AR. The choice of treatment depends on symptom severity, frequency, and patient preference. Pharmacological options include antihistamines, corticosteroids, decongestants, leukotriene receptor antagonists (LTRAs), and immunotherapy, which may be administered orally, intranasally, intraocularly, or via subcutaneous injection. Patients with severe symptoms may benefit from combination therapy rather than monotherapy.1
Antihistamines are a first-line treatment option for AR. Histamine is one of the primary inflammatory mediators of AR. Antihistamines treat histamine-mediated conditions by acting as antagonists at the H₁ receptor, reducing allergy symptoms. Antihistamines are typically administered orally, while intravenous or intramuscular administration is also possible, but is usually reserved for hospital settings for the treatment of specific conditions.
H₁ antihistamines can be classified into first- and second-generation agents. First-generation H₁ antihistamines cross the blood-brain barrier into the central nervous system, whereas secondgeneration H₁ antihistamines do not. The duration of action of first-generation antihistamines is approximately fourto-six hours, while second-generation antihistamines work for 12-to-24 hours. There is a broad range of dosedependent adverse effects associated with antihistamines. Common adverse effects of first-generation H₁ receptor antihistamines include sedation, dry mouth, urinary retention, dizziness, tinnitus, and decreased co-ordination. Secondgeneration antihistamines have a much more favourable adverse effect profile. However, some may be cardiotoxic in certain individuals due to QT-prolonging effects. They also offer ease of use due to their once-daily dosing schedule.1,3
Chlorphenamine is an example of a first-generation antihistamine available over the counter. Second-generation antihistamines available over the counter include fexofenadine, loratadine, and cetirizine, while bilastine and levocetirizine are available on prescription.
Both first- and second-generation antihistamines are effective at controlling symptoms of AR. Second-generation antihistamines exhibit similar efficacy in symptom relief and have favourable safety profiles. Intranasal antihistamines have a rapid onset of action and may be more effective than oral antihistamines in relieving nasal symptoms, as they deliver a higher concentration of medication to the target area. They
may be used in combination with intranasal corticosteroids. Common adverse effects include nosebleeds, headache, and nasal irritation.1,3
Ocular allergic symptoms can be treated rapidly with antihistamine eye drops, which directly target ocular tissue and have a better safety profile due to reduced systemic absorption. They can also be used in combination with oral or intranasal agents. Olopatadine and ketotifen are two antihistamines used in the treatment of ocular symptoms of seasonal allergic conjunctivitis. 4
Corticosteroids exert their effects by reducing inflammatory cytokine production, mast cell proliferation and cell-mediated immune responses. This results in decreased inflammation in the nasal passages and is effective in alleviating symptoms of AR. However, oral corticosteroids are not recommended as first-line treatment due to their associated adverse effects, including weight gain, abdominal pain, fluid retention, mood alterations, increased risk of osteoporosis, and adrenal insufficiency. In certain cases of severe or refractory symptoms, a short course of systemic corticosteroids may be indicated.1,5
Intranasal corticosteroids are the cornerstone of the pharmacological management of AR. Fluticasone propionate, mometasone furoate, and triamcinolone acetonide are commonly used intranasal corticosteroids. They effectively reduce nasal congestion and inflammation. These agents have an onset of action of approximately 30 minutes, although peak effects may take several hours to days, with maximum benefit achieved after two-to-four weeks of consistent use.
Studies have demonstrated that intranasal corticosteroids are more effective than oral antihistamines in reducing nasal inflammation and are therefore considered first-line treatment for AR. Intranasal corticosteroid therapy can be used as monotherapy or in combination with oral antihistamines.
Common adverse effects include nasal irritation, nosebleeds and throat irritation. Proper administration of nasal sprays is essential to achieve an optimal clinical response and minimise adverse effects. Additionally, intranasal corticosteroids require regular use for maximum efficacy.1,5
Oral decongestants, such as pseudoephedrine and phenylephrine, are useful in relieving nasal congestion; however, they are not recommended for long-term daily use due to their adverse effect profile. These medications act on adrenergic receptors, resulting in vasoconstriction of the nasal passages and subsequent reduction of inflammation. Adverse effects of decongestants may include insomnia, heart palpitations and increased blood pressure.
Xylometazoline is an alpha-adrenergic agonist used intranasally to cause vasoconstriction and reduce inflammation. However, prolonged use can lead to rebound nasal congestion (rhinitis medicamentosa); therefore, it should not be used for more than one week.1,6
LTRAs work by blocking leukotriene receptors, thereby inhibiting the function of these inflammatory mediators. Montelukast is an example of an LTRA used in the treatment of AR. It is administered once daily at night. Although not a first-line treatment for AR, it may be used in combination with other medications for severe or refractory cases. It is particularly beneficial in patients with coexisting asthma. Montelukast is relatively well-tolerated and safe, with the most common adverse effects including headache, abdominal pain, nausea and viral infections.1,7
Allergen immunotherapy may be considered in patients where preventive measures and combination pharmacological treatments are
ineffective. It is the only treatment that modifies the disease rather than alleviating the symptoms.
Subcutaneous immunotherapy (SCIT) or sublingual immunotherapy (SLIT) are commonly-used approaches. These therapies involve the administration of gradually increasing doses of the allergen extract until a dose is reached that can effectively induce immunological tolerance. Maintenance doses are typically administered for three-to-five years, providing prolonged and protective effects. The greatest risk associated with immunotherapy is anaphylaxis. However, aside from this risk, allergen immunotherapy has a relatively low incidence of serious adverse effects.1,5
Non-pharmacological strategies play a vital role in the management of AR, particularly when pharmacological treatments are contraindicated or not well-tolerated. They can also be used alongside medications to enhance symptom control.
Nasal irrigation clears allergens from the nasal passages and reduces symptoms. Allergen avoidance should be encouraged to minimise exposure to pollen, animal dander, dust mites and other allergens. Some useful tips to help reduce symptoms of AR are listed below: Monitor pollen forecasts and stay
1. Akhouri S, and House SA (2023). Allergic rhinitis. [online] PubMed.
2. Wang DY (2005). Risk factors of allergic rhinitis: genetic or environmental? Therapeutics and Clinical Risk Management, 1(2), pp.115–123.
3. Farzam K, O’Rourke MC, and
indoors during peak counts, keeping windows and doors closed.
Apply a barrier around the nostrils o trap pollen and other allergens.
Wear wraparound sunglasses to protect the eyes.
Shower and change clothes after being outside.
Use allergen-proof bedding.
Vacuum-clean the home regularly.
Avoid pets or groom them regularly.
Use high-efficiency particulate air (HEPA) filters to trap allergens.
Avoid smoking and exposure to pollutants.1,8
AR is a common condition that significantly impacts quality of life. This is particularly relevant in Ireland, where seasonal triggers are common, and pharmacists can play a crucial role in its management.
Pharmacists can educate patients about potential allergens and how to reduce exposure. They can also assess symptom severity and recommend appropriate over-the-counter treatment for patients, considering potential drug interactions and medication adherence.
Counselling patients on proper medication use, including correct nasal spray and eye drop techniques, is an important aspect of a pharmacist’s job. Finally, pharmacists provide accessible healthcare services and collaborate with other healthcare professionals to ensure optimal patient outcomes. ●
Sabir S (2022). Antihistamines. [online] PubMed.
4. Bielory L (2002). Role of antihistamines in ocular allergy. The American Journal of Medicine, [online] 113(9, Supplement 1), pp.34–37.
5. Sur DK, and Scandale S (2010). Treatment of allergic rhinitis. American Family Physician, [online] 81(12), pp.1440–1446.
6. Empey DW, and Medder KT (1981). Nasal Decongestants. Drugs, 21(6), pp.438–443.
7. Choi J, and Azmat CE (2023). Leukotriene Receptor Antagonists. [online] PubMed.
8. HSE.ie (2024) Hay fever. [online] Available at: https://www2. hse.ie/conditions/hay-fever/.
Ryaltris™ is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis1
indicated in adults and adolescents 12 years of age and older for
severe nasal symptoms associated with allergic rhinitis1
Ryaltris™ 25 mcg/actuation + 600 mcg/actuation nasal spray, suspension.
Prescribing information
Ryaltris™ 25 mcg/actuation + 600 mcg/actuation nasal spray, suspension.
Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.
Ryaltris™ 25 mcg/actuation + 600 mcg/actuation nasal spray, suspension.
Prescribing information
Please consult the Summary of Product Characteristics (SmPC) for full prescribing
Presentation: One delivered dose contains mometasone furoate monohydrate equivalent to 25 mcg mometasone furoate and olopatadine hydrochloride equivalent to 600 mcg olopatadine. White, homogeneous suspension.
Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.
One delivered dose contains mometasone furoate monohydrate equivalent to 25 mcg mometasone furoate and olopatadine hydrochloride equivalent to 600 mcg olopatadine. White, homogeneous suspension.
Uses: In adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis.
Presentation: One delivered dose contains mometasone furoate monohydrate equivalent to 25 mcg mometasone furoate and olopatadine hydrochloride equivalent to 600 mcg olopatadine. White, homogeneous suspension.
In adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis.
Dosage: For nasal use only. Adults and adolescents (12 years of age and over) two actuations in each nostril twice daily (morning and evening). Elderly: no dose adjustment required. Children under 12 years: not recommended. Renal and hepatic impairment: no dose adjustment expected.
Uses: In adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis.
For nasal use only. Adults and adolescents (12 years of age and over) two actuations in each nostril twice daily (morning and evening). Elderly: no dose adjustment required. Children under 12 years: not recommended. Renal and hepatic impairment: no
Dosage: For nasal use only. Adults and adolescents (12 years of age and over) two actuations in each nostril twice daily (morning and evening). Elderly: no dose adjustment required. Children under 12 years: not recommended. Renal and hepatic impairment: no dose adjustment expected.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Presence of untreated localised infection involving the nasal mucosa, such as herpes simplex. Recent nasal surgery or trauma until wound healing has occurred.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Hypersensitivity to the active substance or to any of the excipients. Presence of untreated localised infection involving the nasal mucosa, such as herpes simplex. Recent nasal surgery or trauma until wound healing has occurred.
Warnings and Precautions: Instances of nasal ulceration and nasal septal perforation have been reported. Not recommended in case of nasal septum perforation. Patients using Ryaltris™ over several months or longer should be examined periodically for possible changes in the nasal mucosa and for evidence of Candida infection. Instances of epistaxis have been reported. Visual disturbance may be reported with systemic and topical corticosteroid use. Consider referral to ophthalmologist with symptoms such as blurred vision or other visual disturbances as cataract, glaucoma or rare diseases such as central serous chorioretinopathy have been reported after use of systemic and topical corticosteroids. Hypersensitivity reactions, including wheezing, may occur - discontinue. Immunosuppression: use with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex. Potential systemic effects of corticosteroids include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Hypercorticism and adrenal suppression may appear at higher than recommended dosages or in susceptible individuals at recommended dosages - discontinue slowly. Increased risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis possible with concomitant use with other inhaled corticosteroids. Careful monitoring needed for acute adrenal insufficiency in response to stress in patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids. In patients with asthma or other conditions requiring long term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of symptoms. Somnolence has been reported following administration of Ryaltris™ in clinical studies. Caution in patients operating machinery or driving a motor vehicle. Avoid concurrent use with alcohol or other central nervous system (CNS) depressants. Increased risk of antihistamine adverse effects with concomitant use of olopatadine or other antihistaminic drugs administered via nasal, ocular or oral route. Paediatric population: It is recommended that the height of children receiving
Presence of untreated localised infection involving the nasal mucosa, such as herpes simplex. Recent nasal surgery or trauma until wound healing has occurred.
Instances of nasal ulceration and nasal septal perforation have been reported. Not recommended in case of nasal septum perforation. Patients using Ryaltris™ over several months or longer should be examined periodically for possible changes in the nasal mucosa and for evidence of Candida infection. Instances of epistaxis have been reported. Visual disturbance may be reported with systemic and topical corticosteroid use. Consider referral to ophthalmologist with symptoms such as blurred vision or other visual disturbances as cataract, glaucoma or rare diseases such as central serous chorioretinopathy have been reported after use of systemic and topical corticosteroids. Hypersensitivity reactions, including wheezing, may occur - discontinue. Immunosuppression: use with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex. Potential systemic effects of corticosteroids include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Hypercorticism and adrenal suppression may appear at higher than recommended dosages or in susceptible individuals at recommended dosages - discontinue slowly. Increased risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis possible with concomitant use with other inhaled corticosteroids. Careful monitoring needed for acute adrenal insufficiency in response to stress in patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids. In patients with asthma or other conditions requiring long term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may
Warnings and Precautions: Instances of nasal ulceration and nasal septal perforation have been reported. Not recommended in case of nasal septum perforation. Patients using Ryaltris™ over several months or longer should be examined periodically for possible changes in the nasal mucosa and for evidence of Candida infection. Instances of epistaxis have been reported. Visual disturbance may be reported with systemic and topical corticosteroid use. Consider referral to ophthalmologist with symptoms such as blurred vision or other visual disturbances as cataract, glaucoma or rare diseases such as central serous chorioretinopathy have been reported after use of systemic and topical corticosteroids. Hypersensitivity reactions, including wheezing, may occur - discontinue. Immunosuppression: use with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex. Potential systemic effects of corticosteroids include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Hypercorticism and adrenal suppression may appear at higher than recommended dosages or in susceptible individuals at recommended dosages - discontinue slowly. Increased risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis possible with concomitant use with other inhaled corticosteroids. Careful monitoring needed for acute adrenal insufficiency in response to stress in patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids. In patients with asthma or other conditions requiring long term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of symptoms. Somnolence has been reported following administration of Ryaltris™ in clinical studies. Caution in patients operating machinery or driving a motor vehicle. Avoid concurrent use with alcohol or other central nervous system (CNS) depressants. Increased risk of antihistamine adverse effects with concomitant use of olopatadine or other antihistaminic drugs administered via nasal, ocular or oral route. Paediatric population: It is recommended that the height of children receiving
prolonged treatment with nasal corticosteroids is regularly monitored. Contains 0.02 mg benzalkonium chloride in each actuation. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
prolonged treatment with nasal corticosteroids is regularly monitored. Contains 0.02 mg benzalkonium chloride in each actuation. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
prolonged treatment with nasal corticosteroids is regularly monitored. Contains 0.02 mg benzalkonium chloride in each actuation. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
Interactions: No interaction studies have been performed with Ryaltris™. Any interactions from the combination of olopatadine and mometasone furoate are expected to reflect those of the components taken individually, no pharmacokinetic interaction between olopatadine and mometasone furoate was observed when administered in combination.
Interactions: No interaction studies have been performed with Ryaltris™. Any interactions from the combination of olopatadine and mometasone furoate are expected to reflect those of the components taken individually, no pharmacokinetic interaction between olopatadine and mometasone furoate was observed when administered in combination. Olopatadine: No interactions with other drugs expected. Mometasone Furoate: Cotreatment with CYP3A inhibitors should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects and patients should be monitored. Pregnancy and Lactation: Avoid use during pregnancy unless potential benefit to mother justifies potential risk to mother, foetus or infant. Assess before prescribing in lactating mothers.
Interactions: No interaction studies have been performed with Ryaltris™. Any interactions from the combination of olopatadine and mometasone furoate are expected to reflect those of the components taken individually, no pharmacokinetic interaction between olopatadine and mometasone furoate was observed when administered in combination. Olopatadine: No interactions with other drugs expected. Mometasone Furoate: Cotreatment with CYP3A inhibitors should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects and patients should be monitored. Pregnancy and Lactation: Avoid use during pregnancy unless potential benefit to mother justifies potential risk to mother, foetus or infant. Assess before prescribing in lactating mothers.
Olopatadine: No interactions with other drugs expected. Mometasone Furoate: Cotreatment with CYP3A inhibitors should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects and patients should be monitored.
Pregnancy and Lactation: Avoid use during pregnancy unless potential benefit to mother justifies potential risk to mother, foetus or infant. Assess before prescribing in lactating mothers.
Side Effects:
Side Effects: Common: dysgeusia, epistaxis, nasal discomfort. Uncommon: dizziness, headaches, somnolence, nasal dryness, dry mouth, abdominal pain, nausea, fatigue. Rare: bacterial vaginosis, anxiety, depression, insomnia, lethargy, migraine, blurred vision, dry eye, eye discomfort, ear pain, nasal inflammation, nasal mucosal disorder, oropharyngeal pain, sneezing, throat irritation, constipation, sore tongue, laceration.
Side Effects: Common: dysgeusia, epistaxis, nasal discomfort.
Frequency not known: pharyngitis, upper respiratory tract infection, hypersensitivity (including anaphylactic reactions, angioedema, bronchospasm, dyspnoea), cataracts, glaucoma, increased intraocular pressure and nasal septum perforation.
Uncommon: dizziness, headaches, somnolence, nasal dryness, dry mouth, abdominal pain, nausea, fatigue. Rare: bacterial vaginosis, anxiety, depression, insomnia, lethargy, migraine, blurred vision, dry eye, eye discomfort, ear pain, nasal inflammation, nasal mucosal disorder, oropharyngeal pain, sneezing, throat irritation, constipation, sore tongue, laceration.
Pack Sizes: One bottle containing 30ml suspension (240 actuations).
Frequency not known: pharyngitis, upper respiratory tract infection, hypersensitivity (including anaphylactic reactions, angioedema, bronchospasm, dyspnoea), cataracts, glaucoma, increased intraocular pressure and nasal septum perforation.
Uncommon: dizziness, headaches, somnolence, nasal dryness, dry mouth, abdominal pain, nausea, fatigue. Rare: bacterial vaginosis, anxiety, depression, insomnia, lethargy, migraine, blurred vision, dry eye, eye discomfort, ear pain, nasal inflammation, nasal mucosal disorder, oropharyngeal pain, sneezing, throat irritation, constipation, sore tongue, laceration. Frequency not known: pharyngitis, upper respiratory tract infection, hypersensitivity (including anaphylactic reactions, angioedema, bronchospasm, dyspnoea), cataracts, glaucoma, increased intraocular pressure and nasal septum perforation.
Pack Sizes: (240 actuations).
Legal Category: POM.
Product Authorisation Numbers: PA 1543/002/001
Pack Sizes: One bottle containing 30ml suspension (240 actuations).
Legal Category:
Legal Category: POM.
Product Authorisation Numbers:
Product Authorisation Holder: Glenmark Pharmaceuticals s.r.o., Hvezdova 1716/2b, 140 78 Prague 4, Czech Republic.
Product Authorisation Numbers: PA 1543/002/001
Marketed by: A. Menarini Pharmaceuticals Ireland Ltd.
Product Authorisation Holder: s.r.o., Hvezdova 1716/2b, 140 78 Prague 4, Czech Republic.
Product Authorisation Holder: Glenmark Pharmaceuticals s.r.o., Hvezdova 1716/2b, 140 78 Prague 4, Czech Republic.
Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.
Marketed by: Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.
Date of Preparation: December 2023.
Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.
Date of Preparation:
Date of Preparation: December 2023.
May marks World IBD Day 2025, where healthcare professionals and patients unite to educate and inform on irritable bowel disease
Each year, 19 May marks World IBD Day 2025, which will see a number of international initiatives to recognise the challenges and opportunities in treating irritable bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC). Each year, the event sees organisations and individuals across the world help to break the taboos and stigma around IBD, in particular the difficulty many patients have in
discussing their bowel movements.
The European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA) is an umbrella group that comprises IBD advocacy associations throughout Europe. The EFCCA engages with other organisations and policy-makers in an effort to challenge societal norms and taboos around bowel health, and IBD in particular. The group says it aims to normalise conversations about IBD, making it easier for people to talk
openly about their experiences and dispelling stigma.
This openness is designed to positively influence clinical practice to foster better care for IBD patients everywhere, and foster early diagnosis where appropriate.
Pharmacists are on the front line when it comes to recognising the early symptoms of IBD. As the symptoms can often mimic irritable bowel syndrome
(IBS), there is potential for IBD to be missed in its early stages. This is often compounded by patients receiving confusing and sometimes conflicting information from Internet searches.
Pharmacists can help educate patients and open the dialogue that is promoted by the EFCCA and similar organisations. Pharmacists are also an important link in the IBD care ‘chain’, as they can refer patients to their GP for further investigation if IBD is suspected.
Therefore, correctly distinguishing IBD from IBS or other gastroenterological symptoms is important to positively affect patient outcomes.
True diagnosis can be confirmed by medical tests, but generally speaking, the Crohn’s and Colitis Foundation says the following helps to differentiate the two conditions.
IBS features
Chronic and persistent abdominal pain.
Constipation alternating with diarrhoea.
Mucus in the stool.
Gassiness.
Abdominal bloating, or the sensation of feeling full.
Abdominal distention, or swelling.
The urge to move your bowels without being able to have a bowel movement.
Nausea.
IBD features
Crohn’s and Colitis Ireland outlines the main symptoms of IBD, which are listed below. The most predominant overlapping symptom with IBD and IBS is diarrhoea and loose stools. The symptoms and disease severity vary from person-to-person, the location of the disease, and the individual’s response to the disease. However, the symptoms can be broadly listed as:
Fever (sometimes in the form of night sweats).
Fatigue, tiredness.
Anaemia (low blood count).
Nausea, vomiting.
Cramps, abdominal pain.
Fistulae, particularly perianal fistulae (connections or short cuts between the bowel and the skin or the bowel and other organs).
Skin tags.
Weight loss.
Mouth ulcers.
Deep ulcers in the bowel or stomach.
Growth can be affected with children. IBD is classified as a disease, rather than a syndrome (collection of symptoms). It causes permanent harm to the intestines and destructive inflammation, and results in an increased risk of colon cancer.
OTC eye treatments as well as something for stomach complaints. UC can also cause liver abnormalities due to involvement of the cells (chronic active hepatitis) or bile ducts (primary sclerosing cholangitis). The condition can also debilitate a person’s quality of life by inducing anaemia in some cases.
IBD also presents financial challenges, not only for the State, but also for the individual. The organisation Crohn’s and Colitis Ireland has recently been compiling data from new research that
IBD also presents financial challenges, not only for the State, but also for the individual
Again, there are overlapping symptoms between CD and UC, but the symptoms of UC can be broadly listed as:
Diarrhoea/loose stools often with mucus containing blood.
Feeling of being unable to completely empty the bowel.
Bleeding from the bottom.
Fatigue/tiredness.
Anaemia (low blood count).
Cramps, abdominal pain.
Fever occurs in severe cases.
Weight loss is less common than in Crohn’s disease.
Ultimately, UC can lead to strictures, perforations and fistulae and other complications both inside and outside the gut. External complications are less common but can include inflammation of the large and small joints of the arms, legs, pelvis and spine. Skin can become painful, especially on the shins, and eyes can become gritty or watery, which can raise suspicion if a patient is seeking
looks into the cost of IBD, and the release of those figures is expected. However, a 2024 survey showed that 62 per cent of respondents revealed that IBD is a significant financial burden.
Crohn’s and Colitis Ireland hopes the results from the survey will help them to strengthen their advocacy for IBD sufferers and the organisation will present a report to the Department of Health and Finance, urging them to recognise IBD as a long-term illness and to provide better financial support for those suffering with the condition.
It is estimated that there are approximately 40,000 people in Ireland currently diagnosed with IBD. Early diagnosis and treatment are vital to improve outcomes and this year, more than ever, it is important for pharmacists to collaborate with other healthcare professionals in recognising this debilitating disease early and putting patients on the right treatment pathway. ●
Further information is available on request or in the Summary of Product Characteristics (SmPC) at www.medicines.ie
Legal Category: POM.
AMGEVITA® is a registered trademark of Amgen Inc.
Marketing Authorisation Holder: Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands.
Reference:
1. AMGEVITA® (adalimumab) summary of product characteristics
Available at: https://www.medicines.ie/medicines/amgevita-prefilled-pen-34641/spc and https://www.medicines.ie/medicines/amgevita-prefilled-syringe-34642/spc.
Rheumatoid arthritis follows a progressive course and requires a multidisciplinary approach, writes Damien O’Brien MPSI
Rheumatoid arthritis (RA) is a systemic autoimmune condition that affects the synovial joints, leading to inflammation, pain, stiffness and joint destruction. It is a chronic inflammatory disorder that involves an interaction between genetic and environmental factors. RA can also cause extraarticular manifestations, including cardiovascular, pulmonary and ocular complications. Without treatment,
RA is a progressive disease with significant morbidity and mortality. It can cause substantial disability and greatly impact patients' quality of life.
RA affects approximately 0.5-to1 per cent of the population, with women being two-to-three times more likely to develop RA than men. The complexity of RA management requires a multidisciplinary approach where pharmacists play a vital role in optimising treatment, providing
patient education, supporting adherence to treatment, and minimising adverse effects. 1,2
The exact aetiology of RA is unclear, but it is accepted that genetic, environmental and hormonal factors play an important role in disease development. The risk of developing RA is linked to the HLA-DR4 and HLA-DR1 genes.
RA results from immune system dysregulation that causes joint inflammation, whereas osteoarthritis arises from mechanical wear-andtear. The fact that women are twoto-three times more likely to develop RA than men suggests that hormonal factors play a role in the development of the disease. Women are also more likely to have a more aggressive disease course with greater disability.
Cigarette smoking is the strongest environmental risk factor for RA. Smoking increases the body’s oxidative stress, disrupts apoptosis, triggers pro-inflammatory processes, and causes DNA methylation. Exposure to certain infectious agents, silica and asbestos is also a risk factor for developing RA. 1,2
The pathophysiology of RA involves complex mechanisms that result in chronic synovial inflammation and joint destruction. An environmental trigger may activate the immune response in genetically susceptible individuals, leading to the loss of immune tolerance and the production of autoantibodies, such as rheumatoid factor and anti-citrullinated protein antibodies (ACPA). This leads to the presence of activated immune cells, such as T cells and B cells, in the synovial membrane, causing the release of pro-inflammatory cytokines like tumour necrosis factor-alpha (TNF- α ) and interleukins. This results in persistent inflammation that can progress to joint deformity and loss of function.
Extra-articular manifestations, including vasculitis and interstitial lung disease, may develop, illustrating the systemic nature of RA. 1
RA follows a progressive course, initially having non-specific symptoms such as fatigue, weight loss and malaise, before developing into more distinct joint symptoms. The severity and pattern of symptoms can vary from individual-to-individual, with periods of flare-ups and remission.
The most common symptoms of RA are pain and inflammation that gradually worsen over weeks and months. The pain is typically symmetrical and affects the small joints of the hands and feet. As RA
features that may be indicative of RA include symmetrical joint involvement, morning stiffness, fatigue, weight loss and inflammation, pain, and warmth in the joints.
Serological testing for the presence of rheumatoid factor or ACPA is useful. RF is present in 80-to-90 per cent of patients with RA, and ACPA is present in 70-to-80 per cent of patients. However, there will be approximately 10 per cent of RA patients with neither RF nor ACPA. Furthermore, the presence of rheumatoid factor is not necessarily diagnostic of rheumatoid arthritis, as it may be present in other conditions such as systemic lupus erythematosus and Sjögren syndrome.
The pathophysiology of RA involves complex mechanisms that result in chronic synovial inflammation and joint destruction
progresses, it can involve larger joints such as the knees, shoulders and elbows. Joint deformities and loss of function can occur over time due to persistent inflammation and erosion of the cartilage and bone. Morning stiffness lasting more than one hour is a classic feature of RA.
Fatigue, malaise, weight loss and low-grade fever are commonly observed systemic symptoms. Extra-articular manifestations may occur, impacting organs and tissues beyond the joints. These may include rheumatoid nodules, Sjögren syndrome, interstitial lung disease, and cardiovascular complications. 1
The diagnosis of RA is based on a combination of clinical, laboratory, and imaging findings, with early diagnosis important for preventing irreversible joint damage and disability. Clinical
Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels are often elevated in patients with active disease and can be used to assess disease activity. X-rays may be useful to illustrate joint space narrowing and bony erosions, while ultrasound and magnetic resonance imaging (MRI) can be used in early disease to detect synovitis. 1
The objective of pharmacological treatment is to control inflammation and prevent irreversible joint damage. Long-term remission, with the absence of symptoms of inflammatory disease, helps to optimise quality of life. In cases where clinical remission cannot be achieved, low disease activity is the aim.
Early treatment with disease-
modifying antirheumatic drugs (DMARDs) is the cornerstone of RA pharmacological treatment. DMARDs can be classified as biologic or nonbiologic. Nonbiologic agents include methotrexate, leflunomide, sulfasalazine and hydroxychloroquine. Biologic agents are a newer class of medications and offer more targeted therapy. Combination therapy with two or more DMARDs may be more effective than monotherapy, but there is a greater risk of adverse effects, which should be carefully considered. If RA is not controlled with a nonbiologic DMARD, a biologic DMARD may be considered. Targeted synthetic DMARDs are a final class of drugs that may be used as second-line therapy in RA. 1,3
Methotrexate is a first-line treatment for RA due to its efficacy, safety, low cost and flexibility of administration. It may be used as monotherapy or in combination with other DMARDs. It is an immunosuppressive drug that acts as an antifolate antimetabolite. It inhibits enzymes involved in purine synthesis, which reduces T cell and B cell activity. This reduces the activity of the immune system and thereby reduces inflammation in RA. It is administered once weekly, and in patients who still have disease activity, the dose can be split into twice daily on that day to increase bioavailability. Subcutaneous injection may be used in patients who do not respond adequately or are intolerant to oral administration. Gastrointestinal issues are the most common adverse effects associated with methotrexate, including nausea, vomiting, pain and ulceration. Other adverse effects include fatigue, alopecia, hepatotoxicity, increased risk of infection, and malignancy. A folic acid dose of at least 5mg once weekly can reduce the risk of adverse effects and toxicity. Patients on methotrexate require regular blood tests to monitor liver function, renal function and bone
marrow deterioration.1,3,4
Leflunomide is a medication that may be used in combination with methotrexate or as an alternative treatment option in patients with poor tolerance to methotrexate. It inhibits the synthesis of uridine monophosphate pyrimidine and thereby inhibits the reproduction of lymphocytes, promoting antiinflammatory and immunomodulatory effects. It is administered orally once daily. It is effective in reducing symptoms and slowing the progression of RA. Common adverse effects include gastrointestinal issues, liver damage, hypertension, and alopecia. 4,5,6
Sulfasalazine is a DMARD that can be used as monotherapy or combination therapy in the treatment of RA. The mechanism of action is
adverse effects include gastrointestinal, skin, and ocular problems. 3,4,5
Biologic DMARDs are a newer option for treating RA in cases where nonbiologic medications are ineffective or poorly tolerated. They are effective in slowing the progression of joint damage and provide a direct targeted therapy on the immune system. They are genetically modified molecules that are divided into several classes, based on their mechanism of action. 5
TNF- α is a pro-inflammatory cytokine that promotes inflammation in joints. TNF- α inhibitors, including etanercept, infliximab, adalimumab, golimumab and certolizumab pegol, block the action of TNF- α and therefore bring symptom relief.
Combination therapy with two or more DMARDs may be more effective than monotherapy, but there is a greater risk of adverse effects
not fully understood, but it is thought that it may reduce the secretion of interleukins. It may be useful as monotherapy in patients with low disease activity and who lack poor prognostic features. It is administered orally and generally is quite well tolerated, but should be avoided in individuals with sulfa allergies. Common adverse effects include gastrointestinal problems, rash, urticaria and reversible male infertility. 3,4,5
Hydroxychloroquine is an antimalarial drug used in the treatment of RA. It works by decreasing the secretion of proinflammatory cytokines. It is a suitable treatment option for early or less-aggressive RA. It is administered orally and has the benefit of possessing a favourable safety profile, with no myelosuppressive, renal and hepatic adverse effects. Common
Interleukin (IL) 6 inhibitors, such as tocilizumab, and IL-1 inhibitors, such as anakinra, have a similar mechanism of action. They work by blocking the action of interleukins, cytokines that are involved in persistent inflammation. Abatacept is a T cell costimulation inhibitor that modulates T cell activation to reduce inflammation. 1 Biologics are immunomodulators that target the disease-causing mechanism and have been used more in treating RA in recent years. They can have a significant positive impact on disease activity and a good safety profile. They can be used as first-line treatment for severe RA, but are more commonly used if other conventional treatments are ineffective or not tolerated.
Biologics tend to be expensive, and they also have a risk of serious adverse effects. Due to
their immunosuppressive nature, they increase the susceptibility to infection. Patients therefore require screening before initiation of therapy, and monitoring while taking the medication. Other adverse effects include fatigue, fever, increased risk of malignancy, and increased risk of multiple sclerosis. They are often used in combination with nonbiologic DMARDs, particularly methotrexate. Biologics are typically administered by either intravenous infusion or subcutaneous injection, with the dosing schedule varying between the different medications. 1,3,4,5
Targeted synthetic DMARDs are not biologics, but may be useful in the second-line treatment of RA if other therapies have failed. Janus kinase (JAK) inhibitors, such as tofacitinib, inhibit intracellular signalling pathways involved in cytokine production, thereby reducing inflammation. Tofacitinib is orally administered twice daily, as monotherapy or in combination with MTX. It should not be used in combination with biologic medications. Common adverse effects include upper respiratory tract infections, hypertension, gastrointestinal issues, and hyperlipidaemia, while more serious adverse effects include malignancy and opportunistic infections.1,5
Non-steroidal antiinflammatory drugs (NSAIDs) and corticosteroids
Pharmacological management of RA may involve the use of NSAIDs and corticosteroids for controlling pain and inflammation. These should only be used in the short-term treatment of RA, with DMARDs the preferred therapy for long-term management. NSAIDs work by blocking the cyclooxygenase enzymes, thereby inhibiting the synthesis of prostaglandins, which are mediators involved in inflammation and pain. NSAIDs do not possess disease-
modifying effects, but may be effective in relieving symptoms of inflammation and pain.
Aspirin and ibuprofen are examples of NSAIDs available over-the-counter, with celecoxib, etoricoxib, diclofenac, meloxicam, naproxen, dexketoprofen and mefenamic acid available on prescription. The adverse effects of NSAIDs include gastrointestinal discomfort, gastrointestinal bleeding, hepatotoxicity, reduced kidney function, hypertension, and thromboembolic events. 1,3
Corticosteroids are also effective in reducing inflammation and pain in RA. Corticosteroids have two main indications in RA — used as bridging therapy for DMARDs until their effects start, and as adjuncts to treatment in exacerbations. Long-term use of corticosteroids is discouraged due to their adverse effect profile. Potential adverse effects include immunosuppression, reduced bone mass density, weight gain, and diabetes. Corticosteroids should not be abruptly withdrawn, as this can lead to adrenal insufficiency and flares of RA. 4
Non-pharmacological management of RA is important in addition to pharmacological therapy, with the objective of improving patients’ quality of life and slowing disease progression. Smoking cessation and maintaining a healthy weight are important lifestyle modifications that can help reduce disease activity. A diet high in omega fatty acids, including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), may reduce inflammation and be beneficial in RA. Physiotherapy and occupational therapy may also be effective in reducing inflammation and improving joint function. Joint surgery is an option for individuals
with severe RA, which may provide pain relief and improve joint function. 5
Pharmacists play an integral role in the multidisciplinary care of RA patients, offering expertise in medication management, patient education, and medication adherence support. Pharmacists are important in optimising medication regimens for patients with RA, ensuring appropriate drug selection, dosing and monitoring. They can also identify and reduce the incidence of adverse effects and drug interactions.
Pharmacists can educate patients on the importance of medication adherence to ensure optimal clinical outcomes. Furthermore, they can provide counselling on correct administration techniques for injectable medications.
In conclusion, pharmacists are accessible and knowledgeable healthcare professionals, and can collaborate with other healthcare providers to reduce symptoms and enhance the quality of life for individuals living with RA. ●
References
1. Chauhan K, Jandu J, and Al-Dhahir M (2023). Rheumatoid Arthritis. [online] PubMed.
2. Venetsanopoulou AI, Yannis Alamanos, Voulgari, PV, and Drosos AA (2023).
Epidemiology and Risk Factors for Rheumatoid Arthritis Development. Mediterranean Journal of Rheumatology. [online] 34(4), pp.404–404.
3. Wasserman AM (2011). Diagnosis and Management of Rheumatoid Arthritis. American Family Physician, 84(11), pp.1245–1252.
4. Bullock J, Rizvi, Syed AA, Saleh, Ayman M, Ahmed, Sultan S, Do, Duc P, Ansari, Rais A, and Ahmed J (2019). Rheumatoid arthritis: a Brief Overview of the Treatment. Medical Principles and Practice
5. Radu AF, and Bungau SG (2021). Management of Rheumatoid Arthritis: An Overview. Cells , [online].
6. Padda IS, and Goyal A (2021). Leflunomide. [online] PubMed.
Eamonn Brady MPSI examines the current range of kidney transplant medication advice and what to avoid
Our kidneys are situated at our lower back behind the stomach, one each side of the spinal cord, with the lower ribs acting as a cage for the kidneys, helping to prevent injury.
Each kidney is approximately the size of a person’s fist. The main role of the kidneys is to filter waste products and excess water from the blood; produce hormones to regulate blood pressure and red blood cell production; and maintain balance of water, salts, and acid.
Kidney failure is usually caused by a condition that prevents the kidneys from functioning normally — including the likes of diabetes mellitus, high blood pressure, polycystic kidney disease, and glomerulonephritis.
Injury and birth defects can also cause kidney failure. Damage to the kidneys from a condition like diabetes can take years before the effects of kidney failure start to be noticed.
A sudden loss of kidney function is rarer but can occur due to some conditions. Kidney failure causes problems like a build-up of waste products and fluids and can end up developing into side-effects like tiredness and fatigue, oedema (swelling) in ankles and face, nausea, and a poor appetite.
Kidney transplants are not a cure, but they allow maintenance of a normal standard of living. A successful kidney transplant should mean a patient no longer needs dialysis, and fluid and diet restrictions end. Energy levels should increase as the new kidneys start producing red blood cells.
the transplant team?
Temperature is 38.3 o C or higher. Do not take temperature-reducing
medication such as paracetamol until speaking to a member of the transplant team. Taking the likes of paracetamol to decrease temperature means the transplant team cannot determine the level of temperature increase, thus making possible rejection diagnosis more difficult.
Weight increases by two-to-three pounds in one day, or five-to-seven pounds over three-to-five days.
Urine output halves within a 24-hour period (ie, 2,000ml then 1,000ml 24 hours later).
Changes to urine pattern, ie, pain or
bleeding while urinating.
Pain, swelling, tenderness, or drainage in the area of the new kidney.
Nausea, vomiting, or diarrhoea.
Cold or flu-like symptoms, ie, sore throat, fever, chills, etc (can be a sign of reaction to anti-transplant medication).
Blood pressure is outside regular readings, or below 90/60 or greater than 170/110.
Patients need to let a dentist know if they have had a kidney transplant. It is recommended to take an antibiotic before any dental work, including cleaning. Experts advise Amoxicillin 2g one hour before the dental procedure. If allergic to penicillin, Clindamycin (Dalacin C) 600mg one hour before the procedure may be used instead.
Some therapies interfere with the immunosuppressive medications. They can include meds for cold, allergy, cough syrup, or antibiotics. Antibiotics to avoid include clarithromycin (Klacid), erythromycin, and azithromycin (Zithromax). Other drugs to avoid include the antifungal fluconazole (Diflucan) and the heart rhythm drug diltiazem (Dilzem). Avoid grapefruit or grapefruit juice when prescribed Neoral, Prograf, or Rapamune, as it changes the metabolism of these medications. Avoid magnesium oxide or antacids such as calcium carbonate, Rennies, Maalox, or Gaviscon within two hours of taking medications, as they may reduce absorption of some drugs such as immunosuppressants and antibiotics.
There are very few scientific studies to indicate whether herbs are effective, safe, or interfere with prescribed medications. Herbs can cause serious interactions and kidney problems for patients with renal failure and those taking medications after a transplant. Possible issues with herbs are:
Interactions between herbs and medications, which can include reducing the effectiveness of transplant rejection medication.
Herbs may not be pure because of unregulated manufacturing procedures. Herbs come from plants that may cause bacterial, fungal, or parasitic infections. There have been reports of herbs containing pesticides and metals, including lead and mercury.
Some herbs have toxic effects on the liver, kidneys, and heart, especially when taken with other medication, and can result in changes in blood pressure, blood sugar, and potassium levels, leading to risk of bleeding and transplant rejection.
Dosages can vary from pill-to-pill, manufacturer-to-manufacturer, or from what is stated on the label.
To be safe, transplant patients should avoid herbal preparations.
Cyclosporin prevents the body rejecting the new kidney. It is available in 100mg and 25mg capsules. If a patient forgets to take a dose of Cyclosporin and it is less than six hours since the missed dose, they can take the missed dose and go
Some therapies interfere with the immunosuppressive medications. They can include meds for cold, allergy, cough syrup, or antibiotics
back to the normal schedule with the next dose. If it has been longer than six hours, skip that one dose and go back to normal schedule with the next dose. Never double-up a dose. If more than one dose is missed because of vomiting, inability to swallow, or any other reason, let the transplant team know immediately.
Possible side-effects with Cyclosporin include high blood pressure, hand tremors, tingling sensation in hands and feet, increased hair growth on face, and gum problems. Increased creatinine levels can occur due to high Cyclosporin blood levels.
Tacrolimus prevents the body rejecting the new kidney. This medication is available in 1mg (white), 5mg (pink) and 0.5mg (white) smaller capsules. It must be taken twice a day.
If a patient forgets to take a dose of Tacrolimus and it is less than six hours since the missed dose, take the missed dose and get back on schedule with the next dose. If it has been longer than six hours, skip that one dose and get back on schedule with the next one. Do not double-up. If more than one dose is missed due to vomiting, inability to swallow, or any other reason, notify the transplant team immediately.
Some side-effects that have been reported with Tacrolimus are hand tremors, burning or tingling of the mouth, hand, or feet (this will likely improve as the dose is reduced), headaches, difficulty sleeping, high blood sugars, high blood pressure, nausea and/or vomiting (if this occurs, try taking with food), and an increase in creatinine.
Prednisone is a steroid that prevents or treats rejection of the new kidney. The dose may be increased or decreased depending on response. High doses of Prednisone may be prescribed immediately after the
transplant to prevent rejection, with the dose gradually reducing once the transplant is deemed successful. Prednisone may need to be taken longterm. It should be taken with food to prevent stomach irritation. If a patient forgets to take a dose of Prednisone, take the missed dose as soon as possible and get back on schedule with the next dose. Never double-up a dose. If more than one dose is missed due to vomiting, inability to swallow, or any other reason, let the transplant team know immediately.
The adrenal glands make a hormone called cortisol that is very similar to Prednisone and after a few weeks of taking prednisolone, the adrenal glands stop making this hormone. Prednisone should never be stopped abruptly; it should be gradually tapered-off slowly to give the adrenal glands a chance to start making cortisol again. Sudden withdrawal can cause severe fatigue, weakness, body aches, and joint pains, and possibly even cause life-threatening symptoms. Notify your doctor if taking steroids and carry a ‘steroid treatment card’ at all times. A steroid treatment card alerts any medic who treats a patient that they must keep administering steroids.
Side-effects include:
Stomach irritation;
Blurred vision or disturbed eyesight. Long-term use gives risk of cataracts or glaucoma;
Bone or joint pain, especially in hips;
Raised blood pressure;
Diabetes;
Weight gain;
Rounded, puffy face (called ‘moon face’);
Acne;
Insomnia;
Low mood;
Muscle weakness;
Slow wound healing;
Bruising;
Stretch marks;
Dry skin.
Sirolimus may be combined with other immunosuppressive medications to prevent organ rejection. If a dose of Sirolimus is forgotten, take the missed dose as soon as possible and get back on schedule with the next dose. Never double up a dose. If more than one dose is missed due to vomiting, inability to swallow, or any other reason, let the transplant team know immediately.
Side-effects include:
Headache;
Swelling;
Tremor;
Insomnia;
Diarrhoea, nausea, vomiting;
Constipation and bloating;
Low platelet count or anaemia;
High or low potassium levels;
Diabetes;
Back or abdominal pain;
Cough;
Rash or acne;
High cholesterol. Blood counts (white blood cells, platelets, haemoglobin) need to be monitored while on sirolimus. It can cause anaemia (low red blood cells). If it does, the sirolimus dose will be lowered or held for a while and the patient may be prescribed erythropoietin (Aranesp). Erythropoietin is a naturally occurring hormone produced in the kidneys to produce red blood cells. Neupogen may be prescribed if neutrophils (a type of white blood cell) are low, as sirolimus can cause neutropaenia (low levels of neutrophils). Cholesterol levels can be increased by sirolimus, so a cholesterollowering medication (ie, a statin) may need to be prescribed.
Mycophenolate Mofetil (Cellcept) may be combined with other immunosuppressive medications to prevent organ rejection. Mycophenolate comes in 250mg capsules or 500mg tablets. It is usually taken two-to-four times a day and the usual total daily dose is 1,000-2,000mg.
If taking Mycophenolate four times a day and a dose is forgotten:
If less than two hours since the missed dose, take the missed dose and get back on schedule with the next dose. If it is close to the next dose, skip the missed dose and resume normal schedule.
If taking Mycophenolate twice a day and a dose is forgotten:
If it is less than six hours since the missed dose, take the missed dose and get back on schedule with the next dose. If more than six hours since missing dose, skip that dose and get back on schedule with the next dose. Never double-up a dose. If more than one dose is missed due to vomiting, inability to swallow, or any other reason, let the transplant team know immediately.
Side-effects include:
Nausea and vomiting;
Diarrhoea or constipation;
Stomach pains and cramps;
Low white blood cell count;
Anaemia;
High or low potassium levels;
Tremor;
Headache;
Diabetes;
Insomnia.
Blood counts (white blood count and haemoglobin) must be monitored regularly while taking Cellcept. If blood counts are less than the normal range, Cellcept may be lowered or held. Neupogen will need to be prescribed to increase white cell count, or erythropoietin (Aranesp) will need to be prescribed to increase red cell count. Cholesterol levels can be increased by Cellcept so a cholesterollowering medication (ie, a statin) may need to be prescribed.
Immunosuppressants reduce the body’s ability to fight infections, meaning a patient may need to be prescribed medication to prevent infections while on immunosuppressants.
Co-trimoxazole (Septrin)
Septrin is an antibiotic used to prevent and/or treat pneumonia and other bacterial infections.
Immunosuppressants increase the risk of pneumonia and other infections as they reduce the body’s ability to fight infections. Drink plenty of fluids while taking Septrin.
Side-effects include:
Nausea;
Rash;
Itching;
Increased risk of sunburn.
Valganciclovir (Valcyte), acyclovir (Zovirax), valacyclovir (Valtrex)
These antivirals are used for the treatment and prevention of viral infections, including cytomegalovirus (CMV), which is a type of herpes virus transmitted via bodily fluids. Valtrex is used to prevent or treat herpes simplex and shingles. Valtrex will not cure herpes virus completely, but it will reduce the pain and help heal the sores.
Valganciclovir (Valcyte) or acyclovir (Zovirax) are mainly used to treat and prevent CMV. Antivirals are usually prescribed for about three months after transplant. Men should take contraceptive precautions while taking these drugs due to the risks of birth defects.
Side-effects include:
Headaches;
Fever;
Nausea and vomiting;
Diarrhoea;
Low blood counts;
Insomnia.
Taking antivirals with food or milk will increase absorption and reduce stomach irritation. Blood counts must be monitored when taking antivirals and, if lower than expected, the anti-viral must be lowered or held. Antivirals should be avoided during pregnancy and women must not become pregnant for 90 days after finishing the antiviral course because of the risk of birth defects. Men
should also use barrier contraception (condoms) during and for three months after the course of antivirals.
Diflucan (fluconazole) oral capsules or Mycostatin (nystatin) oral suspension
Antifungal medication is used for the treatment and prevention of fungal infections of the mouth and throat. Antifungals usually need to be prescribed for about three months. Immunosuppressant medication increases the risk of fungal mouth infections and symptoms include mouth sores, white coating on tongue, or difficulty swallowing. Antifungal medication may need to be recommenced at different stages in the years after the transplant.
stomach ulcers.
A proton pump inhibitor (PPI) may be prescribed to reduce stomach acid and protect the stomach and prevent ulcers. PPIs used include lansoprazole, pantoprazole, omeprazole, rabeprazole, and esomeprazole.
Antifungal medication may need to be recommenced at different stages in the years after the transplant
Fluconazole and related antifungal medication can interact with some anti-rejection medications, so the doses of anti-rejection medications will need to be adjusted when starting and stopping antifungal medication. Topical Mycostatin oral suspension (nystatin) does not interact with the anti-rejection drugs in the same way.
Side-effects include:
Nausea and vomiting;
Diarrhoea;
Mouth and throat irritation;
Unpleasant taste.
Anti-rejection medication can irritate the stomach lining and bring on
Rejection occurs as the body recognises the transplanted kidney as a foreign object, thus the transplanted kidney is attacked by the body’s immune system. Rejection is possible even if all precautions are taken. It is reckoned that 50 per cent of kidney transplant patients will suffer at least one rejection episode; however, a rejection episode does not mean the patient will lose the kidney. Swift action from the transplant team (ie, increasing immunosuppressant dose or changing to a different dose) will normally stop the rejection and save the kidney. This is why it is so important to recognise the symptoms of rejection, as getting quick treatment will save the kidney in most cases. The first rejection episode occurs within six months of transplant surgery in most cases. Rejection may be chronic, meaning that it occurs slowly over a long period of time, or it can be acute, which means it occurs suddenly. The patient may feel perfectly well during a rejection episode, which is why it is important to have lab tests checked regularly. High laboratory results (blood, urea, nitrogen, and creatinine) can mean a rejection episode is occurring. An ultrasound or renal scan can help confirm a rejection episode and a kidney biopsy can act as a final confirmation. Possible symptoms of a rejection episode:
Temperature of 38.3 o C or higher;
Urine output halves, ie, if normal fluid intake is about 2,000ml per day and output reduces to 1,000ml. Urine output should roughly equal to fluid intake, so if drinking 2,000ml per 24-hour period, then urine output should also be about 2,000ml (though a 300 to 400ml
difference is acceptable);
Weight increases by five pounds or more within three days;
Fluid retention, which can show as mild swelling of the face, feet, hands, ankles, and legs;
If two blood pressure readings (taken at least one hour apart) are outside normal range or below 90/60 or above 170/100;
Swelling or tenderness around the transplanted kidney;
Raised Blood Urea Nitrogen (BUN) and creatinine.
How a rejection episode is reversed:
Increasing prednisone dose;
Intravenous (IV) steroids;
Thymoglobulin or OKT3 (antirejection serum);
Reducing Prograf or Neoral dose;
Temporary dialysis may be required. If a rejection occurs, return to dialysis will be necessary. The rejected kidney may remain in place unless fever, pain, swelling, vomiting, etc, occurs. If these symptoms occur, the rejected kidney may need to be removed surgically. Immunosuppressive medications will then be discontinued.
Kidney transplant patients: What OTC medication can be taken?
Medication to avoid
Some medications interfere with the immunosuppressive medications. They can include meds for cold, allergy, cough syrup, or antibiotics. I discussed some medicines to avoid earlier.
What OTC medication is safe?
Headache, fever, and body aches
Paracetamol eases mild pain and fever and is safe for kidney transplant patients. The maximum daily dose of paracetamol is 4,000mg (8 x 500mg tablets).
Non-steroidal anti-inflammatory drugs (NSAIDs) must be avoided, as they can harm the kidneys and interact
with some immunosuppressants. Ibuprofen is a common NSAID sold OTC. Aspirin is a relation of NSAIDs, so should also be avoided unless prescribed for medical reasons, ie, lowdose aspirin to prevent clots.
Antihistamines can be safely used by transplant patients. Loratadine (Clarityn) and cetirizine (Zirtek) are recommended, as they cause less drowsiness than other antihistamines. Chlorpheniramine (Piriton) is also safe to use but is best used at bedtime, as it causes more drowsiness. Antihistamines should be used with caution for those with glaucoma, as they can increase pressure in the eye. They can also cause fluid retention, so are best avoided in those with an enlarged prostate or those experiencing trouble urinating. Sodium cromoglicate eye drops (Opticrom drops) are a safe option to prevent eye allergy symptoms. It works best if begun at least one week before contact with possible allergens. Avoid combination (multi-symptom) cold, sinus, and flu products (Benylin Day and Night, Benylin 4 Flu, Nurofen Cold and Flu). Treat each symptom individually to avoid accidentally giving a drug that can cause kidney problems.
Topical nasal sprays are the safest for congestion problems. Topical decongestants such as xylometazoline (Otrivine and Sudofed nasal spray) should not be used for longer than three days because longer use can cause a rebound effect, making congestion worse. Sodium chloride 0.9% or salt sprays, ie, Sterimar, can ease sinus systems by moistening sinus cavities and acting as a natural anti-inflammatory and they can safely be used long-term. Saline (salt) solutions are also available as nasal washes through various devices or bottles, ie, Neilmed Sinus Rinse.
Oral decongestants, such as pseudoephedrine (Sudafed tablets),
should be used with care for transplant patients as they can raise blood pressure, which can put pressure on the kidneys. Decongestants are often present in many cough and cold remedies, so check the label before trying.
Most throat lozenges, ie, Strepsils, are safe to use and there are sugar-free versions for diabetics.
Guaifenesin (Robitussin, Viscolex, or Exputex) is recommended for chest congestion. Drinking plenty of water can also help loosen chest congestion.
The cough suppressant dextromethorphan (Benylin Dry Cough) is safe to use — use the nondrowsy version during the day, as the night-time version has a sedative antihistamine called diphenhydramine added. Vicks VapoRub can help relieve a cough for a time. For diabetics, use a sugar-free version such as Robitussin Dry Cough Mixture.
Loperamide (Imodium) can be used for short-term relief of diarrhoea. Do not use for longer than 48 hours. For diarrhoea caused by infection, do not treat it with OTC products. If diarrhoea is heavy, bloody, or lasts for more than a day, it is important to get checked by a doctor.
Products safe to use for transplant patients include bulk-forming products (Fybogel); stool softeners, such as docusate (Fletcher’s phosphate enema); stimulants such as bisacodyl (Dulcolax) or senna (Senokot), and osmotic laxatives such as lactulose (Duphalac) and macrogols (Movicol, Molaxole). Do not use stimulant laxatives such as bisacodyl or senna long-term, as this will cause lazy bowel (which causes rebound constipation), prolonged
diarrhoea, and loss of important electrolytes (sodium, potassium, etc). Lactulose is a good option if a laxative is needed long-term, as it doesn’t cause long-term problems. If constipation last longer than 48 hours, see a doctor.
Mild stomach upset can be eased with some OTC remedies such as antacids (ie, Rennies), famotidine (Pepcid AC), and pantoprazole. Avoid antacids or magnesium-containing products at the same time as immunosuppressants such as mycophenolate (Cellcept), tacrolimus (Prograf), or sirolimus (Rapamune), as they can reduce absorption of these drugs. Take OTC remedies such as antacids at least
one hour before or two hours after the immunosuppressant. If loose stools, avoid magnesium containing products like Maalox, because magnesium can make diarrhoea worse, or worse again, they can cause magnesium levels to become too high, especially if kidneys are not functioning properly.
Simethicone (Imogas) is recommended for gas, which is a common cause of bloating.
Artificial tear eye drops should be first choice for the symptoms of dry eyes and eye irritation. They replicate the role of natural tears. Drops are often
Headache, fever, body aches
Sneezing, itching, or runny nose
Nasal and sinus congestion
Chesty cough
Chesty cough with congestion
Sore throat
Constipation
Diarrhoea
Indigestion/Heartburn
Gas/bloated stomach
Dry eyes and eye irritation
Skin irritation, insect bites, rashes
Nausea and vomiting
Paracetamol
Chlorpheniramine (Piriton)
Brompheniramine (Actifed)
Xylometazoline (Otrivine spray)
Sodium Chloride 0.9% (Sterimar Nasal spray)
Pseudoephedrine (Sudofed)
Guaifenesin (Robitussin)
Guaifenesin/ Pseudoephedrine (Robitussin Plus)
Antiseptic lozenges/spray (Strepsils)
Lactulose (Duphalac)
Bisacodyl (Dulcolax)
Senna (Senokot)
Loperamide (Imodium)
Famotidine (Pepcid AC)
Pantoprazole
Simethicone (Imogas)
Artificial Tears (Tears Naturale, Artelac Drops)
Hydrocortisone 1% cream
Domperidone (Motilium, Domerid)
used during the day (ie, three times daily) and an ointment or gel is used at night, as they are thicker and tend to last for longer while sleeping. There is no evidence that one brand is any more effective than the next. Examples include Tears Naturale and Artelac Drops. They should not be used for contact lens-associated irritation.
Domperidone (Motilium, Domerid) can be used to treat and prevent symptoms of nausea and vomiting, but should only be used short-term and at the lowest possible dose (maximum of one 10mg tablet three times daily). See a doctor if nausea and vomiting lasts more than 24 hours, as it can be caused by prescription medication.
bites, and poison ivy
Topical corticosteroids, such as hydrocortisone 1% cream (Cortisol 1% cream), are safe to use for skin irritation, insect bites, and skin rashes. Use of corticosteroids should be shortterm (no longer than seven days), as they can thin and mark the skin if used long-term.
Give the gift of life, become an organ donor today. For an organ donor card, contact the Irish Kidney Association on LoCall 1890 543639 or log on to www.ika.ie. ●
Disclaimer: Brands mentioned in this article are meant as examples only and not meant as preference to other brands.
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
The BMW-owned MINI brand, one of the first premium marques to launch an electric option, is rapidly adopting electrification across the line-up. But while the familiar MINI hatch and the larger-than-life Countryman SUV have been launched as new generations with electric power to the fore, there’s also an all-new, all-electric option in the line-up called the Aceman. Weird name aside, this is a compact five-door, five-seat crossover that takes aim at one of the fastest-growing market segments, offering MINI fans all the style and attitude of its established models in an electric-only package that promises to be more practical than the standard car.
Few compact crossovers on sale have the showroom impact of the MINI Aceman. It takes the cheeky, large-headlight face
of the regular MINI, plus some of its other characteristic detailing, but adds roof rails and an angularity that align it with the Countryman in terms of off-road styling.
The Aceman is clearly a road-biased car, though, and its dimensions make it only a little longer and taller than the existing five-door version of the MINI Cooper hatchback.
It undoubtedly holds visual appeal, nonetheless, something buyers can amp up or tone down to their hearts’ (and wallets’) content, as MINI is the king of personalisation. There are Classic, Exclusive, and Sport trim lines for starters, each with their own range of colours, alloy wheel designs and accent detailing, and further enhancement can be found in the John Cooper Works styling options.
Our test car was finished in moody black, disguising the crossover styling to some extent, while its large wheels
made the design pop. Amusingly, as you approach the Aceman with its key on your person, the LED lights front and rear do a little light show and the MINI logo illuminates the ground near the doors.
Practicality has never been a MINI forte, though the five-door version improves on the original and makes the rear seats more accessible. That continues in the Aceman, which has slightly better interior space than that car, nothing more. Adults of average size won’t complain too much about being in the back of this model, while the 300-litre boot behind is larger than those of the two MINI hatchbacks as well — though not by much. You can just about squeeze a charging cable under the boot floor, too.
Back in the main cabin, the Aceman receives the brand’s latest interior
design, material, and technology bundle, as launched last year in other models. Sustainability is at the heart of the construction and material selection, but MINI’s designers have clearly had a lot of fun with it as well.
The traditional circular instrument pod in the centre of the dashboard has been reinvented as a snazzy OLED screen that’s quick to respond to touch and packed full of features. Sensibly, the temperature controls are always visible, though there are lots of quirks to the system, such as a personal digital assistant named Spike and a cheesy “Wahoo!!” emanating from the speakers if you choose the sportiest driving mode. Some will find all this endearing, though thankfully, for the rest of us, they’re not omnipresent.
Interior storage is at a premium as the centre console is quite slim and not very versatile, while the textile-wrapped fascias won’t be to all tastes. We do like how they work with the customisable ambient lighting, however.
On the face of it, a starting price for the Aceman of €39,190 doesn’t sound bad. This is, after all, a premium brand and the car lives up to that. We suspect, however, that few buyers will stick with the standard specification and prices can rapidly rise from there. The entry-level car is the Aceman E, powered by a 184hp electric motor and featuring a battery pack that allows an official range between charges of up to 309 kilometres. It can be had in Classic, Exclusive, or Sport trim lines, the latter rising to €43,393.
The ‘SE’ specification tested here brings with it a more powerful electric motor — producing up to 218hp — and, probably of more importance, a larger-capacity battery. In its most modest (Classic) guise, this allows for a more useful range of up to 404 kilometres. Again, it can be had in all three grades and prices start at €44,720 for the Aceman SE Classic.
Our test car started life as the Aceman SE Sport, priced from €48,923, but with quite a few options fitted, it retails at nearly €57,000. Bizarrely, that’s seven grand more than the range-topping John
Cooper Works Aceman Sport costs, a particularly sporty variant with even more performance on tap. Anyway, all this goes to show that the Aceman can be fair value, or not so much if you go mad with the options.
Ever since BMW relaunched the MINI brand back in the early 2000s it has latched onto the original’s image for 'gokart-like handling' — ie, it was agile and fun to drive. In truth, most MINIs since have lived up to the billing to a certain extent, but we do wonder how much the average buyer cares about such things.
The Aceman, for example, handles very well on a twisty road with exceptional body control, quick steering, and rapid reactions to the driver’s input. But all this superb control comes at the expense of comfort and we suspect that many buyers would gladly give up half the agility in return for double the comfort. The Aceman’s suspension is just a little too firm for our liking, resulting in unwanted jiggling throughout the car over most road surfaces, notably so at lower speeds.
Part of this is likely down to the lowprofile tyres fitted to the 19-inch wheels on our test car. They don’t offer much cushioning from bumps and other imperfections on the road and we’d advise buyers to try to test drive a car sitting on the same size wheels they’re likely to buy. The good news is that the Aceman can be purchased with much smaller rims. And yes, I admit they don’t look as good, but that’s a balancing act every buyer needs to consider for themselves.
The electric MINI hatchback drives a little better than the Aceman, but there’s really not much in it and you can have a larger influence on that with the options chosen. They share electric powertrains and are effectively just as efficient as each other in terms of using the charge in their batteries. The electric MINI hatchback is a little more affordable, but it’s not available as a five-door with electric power so in reality, the Aceman will be chosen as much for its extra practicality as its image. Either way, we expect it to become the brand’s most popular electric vehicle. ●
A paper was recently launched at the RCPI titled Vision and Strategic Approach to Adult Immunisation in Ireland . The paper outlines how healthcare professionals can collaborate to bridge the gap in adult immunisation to protect against morbidity and mortality.
The Irish Institute of Pharmacy (IIOP) recently held a parallel session at the RCSI Charter Meeting 2025. The title of the session was’ Next Generation Pharmacy’ and was chaired by Dr Catriona Bradley, IIOP Executive Director. Some of the topics covered included specialist pharmacists, ePrescribing, and personalised medicine, among others.
i-team Global has unveiled the SAFE-T product family, the world’s first batterypowered cleanroom floor cleaning range. These innovations help businesses keep contamination out of critical environments while saving time, reducing costs, and addressing staff shortages.
Combining stringent floor cleaning ability, ergonomic design and efficient battery systems, these trailblazers transform controlled environments. Industry sectors such as high-tech, semiconductors, medical devices, healthcare, pharmaceuticals, and food production can now meet the required cleanliness standards with less effort.
Traditional cleanroom floor cleaning relies heavily on manual wiping and mopping, which is time-consuming and inconsistent. With powerful mechanical scrubbing and Ultra-Low Particulate Air (ULPA 15) filtration, SAFE-T removes more embedded particles than manual methods, capturing over 99.999% of contaminants as small as 0.1 microns.
When contamination issues occur,
production temporarily comes to a halt. The quicker the cleaning is done, the sooner production can resume. Cleaning teams play a vital role in minimising downtime costs by following strict protocols. With staff shortages becoming
The locations for two additional eating disorder teams has been announced, funded under Budget 2025. Fourteen of the 16 teams are now established.
The new teams will be a Child and Adolescent Mental Health Services (CAMHS) eating disorder team in HSE Midwest, and an adult eating disorder team across the regional health areas of HSE Dublin and Midlands, and HSE Dublin and North East. The new CAMHS eating disorder team will cover Limerick city, county, and Co Clare, and the new adult team will cover counties that to date have not been served by an eating disorder team — Louth,
Meath, Longford, Westmeath, Laois, and Offaly. Their commencement is part of the nationwide rollout of the HSE’s National Clinical Programme on Eating Disorders, and is supported by an additional investment of €1.2 million this year.
The announcement takes place during Eating Disorders Awareness Week, an annual campaign to educate the public about the realities of eating disorders and to provide support to individuals and loved ones impacted by eating disorders.
The Minister for Mental Health, Mary Butler TD said: “I am really pleased to confirm new eating disorder teams
a challenge, smarter processes help ease their workload. These tools are intuitive, easy to use, and require minimal training to get started.
In an already challenging environment, the SAFE-T range is designed to make cleaning easier and reduce physical strain on operators. No more dealing with floor cables or searching for a power socket.
Lightweight machines with ergonomic features and intuitive controls improve both comfort and efficiency. These sustainable products also eliminate single-use mop waste, as well as water and chemical usage.
Each solution is designed specifically for cleanroom settings and the exhaust output is certified to the rigorous ISO standards for these controlled environments:
SAFE-T-IMOP, a vertical scrubber dryer for cleanrooms and sticky mats: ISO 5-6
SAFE-T-VAC, a cordless vacuum cleaner: ISO 4-5
SAFE-T-BOT 45, a robotic scrubber dryer: ISO 5
for the Midwest and Midlands. These multidisciplinary teams will support children and adults with eating disorders, working to assess people’s needs, diagnose eating disorders, and commence person-centered treatment based on a variety of evidence-based interventions.
“Eating disorder teams have greatly enhanced screening and early recognition of eating disorders in Ireland, and are providing swifter access to specialist services.”
By the end of 2025, 14 of the 16 teams outlined in the Model of Care on Eating Disorders will be fully operational.
Meaghers Pharmacy Group recently hosted an online event with worldrenowned sports and exercise specialist Dr Noel McCaffrey.
The founder of ExWell Medical and former Dublin GAA footballer was in conversation with Meaghers Pharmacist and Integrative Health Expert Liz O’Hagan in an Instagram Live event on the @meagherspharmacy page on 18 March.
The event highlighted the wideranging benefits of exercise classes for chronically-ill patients.
ExWell Medical is a rapidlygrowing, not-for-profit social enterprise that has over 6,500 inperson participant visits per week across 44 centres in Ireland. It works
▼(teclistamab)
closely with the HSE, GPs and other healthcare professionals in providing exercise classes to chronically ill patients who are referred to it by medical practitioners.
Dr McCaffrey is a sports and exercise medicine specialist. He was named as one of the United Nations 2022 Healthy Ageing 50, a group of 50 individuals from around the world recognised as outstanding leaders with extraordinary achievements in the area of healthy ageing. Noel – as well as his son Jack – both played senior county football for Dublin GAA.
ExWell’s service has proven impact and is changing the face of community-based chronic illness rehabilitation in Ireland. Participants exercise within the limitations of
their illness and enjoy a socially connected and fun atmosphere during the classes that contributes to their overall wellbeing.
Classes, which emphasise enjoyment and fun, involve a combination of aerobic, resistance, core strength and balance exercises led by trained instructors. All classes have been designed with medical oversight.
This ties in with Meaghers Pharmacy Group’s own approach to promoting wellbeing through the Pharmacy 360 initiative it launched last year. Pharmacy 360 complements patients’ treatment plans by advising them on other factors that might be adding to their conditions.
Teclistamab, an off-the-shelf (ready to use) subcutaneously administered therapy, induced deep and rapid responses in triple-class exposed patients with relapsed and refractory multiple myeloma
Johnson & Johnson Innovative Medicine announced recently that TECVAYLI (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) has been approved for reimbursement in Ireland. Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and
have demonstrated disease progression on the last therapy. The announcement follows conditional marketing authorisation (CMA) from the European Commission (EC) granted in 2022 for teclistamab, a bispecific antibody that redirects CD3-positive T-cells to B-cell maturation antigen (BCMA)-expressing myeloma cells to induce the killing of tumour cells.
Multiple myeloma remains an incurable blood cancer, with nearly all patients relapsing and requiring subsequent therapy. As the disease progresses, relapses for patients become more aggressive with each new line of therapy, and remissions become progressively shorter. Approximately
380 people are diagnosed with multiple myeloma each year in Ireland.
Prof Siobhan Glavey, Consultant Haematologist, said: "Multiple myeloma is a complex disease, and despite important scientific progress, patients who develop relapsed and refractory disease after having been exposed to three major drug classes have limited therapeutic options and generally face poor outcomes. This new treatment option has the potential to provide substantial clinical benefit and new hope to patients, with high rates of deep and durable responses, as well as the added convenience of being off-the-shelf. The reimbursement of teclistamab in Ireland marks a major step towards ensuring Irish patients have access to the most innovative treatments available.”
Michaela Hagenhofer, General Manager, Commercial Operations, Johnson & Johnson Innovative Medicine Ireland, said: "Our ambition to eliminate
multiple myeloma is stronger today than ever before. We aim to reach this goal by investing in cutting-edge innovations that address individual patient needs and offer healthcare professionals options they have not had before. We are proud to have provided early access of teclistamab to Irish patients which not only provided valuable extra time, but also allowed clinicians to gain real-world experience with a bispecific. The reimbursement of teclistamab in Ireland marks exciting progress on this journey and we are proud to bring this innovation to Irish myeloma patients.”
CMA is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the benefit of immediate availability of the medicine outweighs the risk, and the applicant is able to provide comprehensive clinical data in the future.
Teva Pharmaceuticals is pleased to announce that Ireven will now be marketed under the new brand name Venlatev (venlafaxine). Previously, Ireven 75mg (PA1368/002/001) and 150mg (PA1368/002/002) hard prolonged-release capsules were sourced through a third-party provider. Teva has made the decision to manufacture venlafaxine inhouse, creating a new brand name Venlatev.
In addition to Venlatev 75mg (PA1986/099/002) and Venlatev 150mg
(PA1986/099/003), Venlatev will also be available in a 37.5mg dosage (PA1986/099/001). Each pack contains 28 hard prolonged-release capsules. For any queries or further information, please contact your local
The approval was supported by positive results from the multicohort, open-label Phase 1/2 MajesTEC-1 study (NCT03145181 and NCT04557098), evaluating the safety and efficacy of teclistamab in adults with RRMM (n =165). Patients received a weekly subcutaneous injection of teclistamab at a dose of 1.5mg/kg, after receiving step-up doses of 0.06mg/kg and 0.3mg/kg. In the study, 104 out of 165 patients achieved an overall response rate (ORR) of 63 per cent (95 per cent Confidence Interval [CI]; range, 55.2–70.4) after a median of five prior lines of therapy. Notably, 58.8 per cent of patients receiving teclistamab achieved a very good partial response (VGPR) or better and 39.4 per cent achieved a complete response (CR) or better. The median time to the first confirmed response was 1.2 months (range, 0.2–5.5 months) and the median duration of response was 18.4 months (95 per cent CI; range, 14.9–not estimable).
Teva representative. Further 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 www.hpra. ie. Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com.
Date of preparation: February 2025 Job code: GEN-IE-NP-00135
The Food Safety Authority of Ireland’s (FSAI) Food Safety Consultative Council recently held an open meeting to explore the transformative role of artificial intelligence (AI) in food safety. ‘AI in Food Safety: Innovation, Risks, and Opportunities’ brought together leading experts to explore the potential of AI and its real-world applications in reshaping the future of food safety systems.
Over 220 people registered for the event, which took place at the Gibson Hotel in Dublin, with a line-up of Irish and international speakers from the FSAI and representatives from UCD, Kerry Foods, Teagasc, TOMRA, Creme Global, and The Netherlands Food and Consumer Product Safety Authority.
Chaired by Suzanne Campbell, author and journalist, the event also offered insights into the practical applications
of AI technologies, including machine learning, predictive modelling, and machine vision, highlighting their potential to revolutionise food safety systems. Discussions also addressed the challenges and risks associated with AI implementation, underscoring the necessity for robust regulatory frameworks and ongoing research.
Dr Pamela Byrne, Chief Executive, FSAI, highlighted that while AI offers incredible opportunities for enhancing food safety, it also comes with potential risks.
“Artificial intelligence is a powerful tool that can enhance our food safety systems in ways we have never seen before. From ensuring traceability in the food supply chain to creating predictive models for disease outbreaks and implementing machine vision systems for quality control, AI
is already becoming embedded in the day-to-day operations of the agrifood sector.
“As we stand at the intersection of innovation and responsibility, we must be mindful of both the tremendous opportunities and the inherent risks associated with these technological advances. We must ask critical questions: How can we leverage AI to enhance food safety while safeguarding public trust? What steps must we take to ensure that AI technologies are applied responsibly, in line with legislation and best practice, and that the reliance on emerging technologies does not compromise food safety standards? The FSAI remains committed to embracing technology while upholding the highest standards of food safety and consumer protection,” said Dr Byrne.
Teva Pharmaceuticals is pleased to announce the launch of Perindopril arginine/Indapamide/Amlodipine Teva, available in four strengths:
Perindopril arginine/Indapamide/ Amlodipine Teva 5mg/1.25mg/5mg Film-coated Tablets.
Perindopril arginine/Indapamide/ Amlodipine Teva 5 mg/1.25 mg/10 mg Film-coated Tablets.
Perindopril arginine/Indapamide/ Amlodipine Teva 10 mg/2.5 mg/5 mg Film-coated Tablets.
Perindopril arginine/Indapamide/ Amlodipine Teva 10 mg/2.5 mg/10 mg Film-coated Tablets.
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. Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com.
Date of preparation: February 2025
Job code: GEN-IE-NP-00144
Film-coated Tablets
perindopril arginine/ indapamide/amlodipine
Perindopril arginine/Indapamide/Amlodipine Teva:
As substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril/indapamide fixed dose combination and amlodipine, taken at the same dose level.
Perindopril arginine/Indapamide/Amlodipine Teva Abbreviated Prescribing
Information
Presentation: Each film-coated tablet contains 5mg or 10mg perindopril arginine, 1.25mg or 2.5mg indapamide and 5mg or 10mg of amlodipine. Indications: As substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril/indapamide fixed dose combination and amlodipine, taken at the same dose level. Dosage and administration: For oral use. Adults: One Perindopril/Indapamide/Amlodipine film-coated tablet per day as a single dose. Children: Not recommended for use in children and adolescents. Elderly: Elimination of is decreased in the elderly. Treatment should be initiated after considering blood pressure response and renal function. Renal impairment: Contraindicated in patients with severe renal impairment (creatinine clearance below 30mL/min). In patients with moderate renal impairment (creatinine clearance 30-60mL/min), treatment at doses of 10mg/2.5mg/5mg and 10mg/2.5mg/10mg is contraindicated. In patients with creatinine clearance greater than or equal to 60ml/min, no dose modification is required. Hepatic impairment: Contraindicated in patients with severe hepatic impairment. In patients with mild to moderate hepatic impairment, Perindopril/ Indapamide/Amlodipine should be administrated with caution, as dosage recommendations for amlodipine in these patients have not been established. Contraindications: Hypersensitivity to the active substances, to other sulphonamides, to dihydropyridine derivatives, any other ACE-inhibitor or to any of the excipients. History of angioedema (Quincke’s oedema) associated with previous ACE inhibitor therapy. Dialysis patients. Patients with untreated decompensated heart failure. Severe renal impairment. Moderate renal impairment for Perindopril/Indapamide/ Amlodipine 10mg/2.5mg/5mg and 10mg/2.5mg/10mg. Hereditary/idiopathic angioedema. Second and third trimesters of pregnancy. Hepatic encephalopathy. Severe hepatic impairment. Hypokalaemia. Combination with non-antiarrhythmic agents causing Torsades de Pointes. Severe hypotension. Shock, including cardiogenic shock. Obstruction of the outflow-tract of the left ventricle (e.g. high-grade aortic stenosis). Haemodynamically unstable heart failure after acute myocardial infarction. Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment. Concomitant use with sacubitril/valsartan therapy. Extracorporeal treatments leading to contact of blood with negatively charged surfaces. Significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Precautions and warnings: The combination of lithium and the combination of perindopril/indapamide is usually not recommended. There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). If dual blockade therapy is considered necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. The combination of perindopril and potassium-sparing drugs, potassium supplements or potassium containing salt substitutes is usually not recommended. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. Perindopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function. There is an increased risk of hypotension and renal insufficiency when patient with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with ACE inhibitors. Treatment with diuretics may be a contributory factor. Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin converting
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 Prescription Only Medicine.
enzyme inhibitors, including perindopril. This may occur at any time during treatment. In such cases perindopril should be discontinued promptly. Angioedema associated with laryngeal oedema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, which may include subcutaneous epinephrine solution and/or measures to ensure a patent airway, should be administered promptly. There have been isolated reports of patients experiencing sustained, life-threatening anaphylactoid reactions while receiving ACE inhibitors during desensitisation treatment with hymenoptera (bees, wasps) venom. ACE inhibitors should be used with caution in allergic patients treated with desensitisation and avoided in those undergoing venom immunotherapy. Rarely, patients receiving ACE inhibitors during low density lipoprotein (LDL)apheresis with dextran sulphate have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE-inhibitor therapy prior to each apheresis. Patients with primary hyperaldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the reninangiotensin system. Therefore, the use of this product is not recommended. ACE inhibitors should not be initiated during pregnancy; when pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately. When liver function is impaired, administration of the diuretic should be stopped immediately if this occurs. If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun. Thiazide diuretics and thiaziderelated diuretics may reduce urinary excretion of calcium and cause a mild and transient increase in plasma calcium levels. Thiazides and related diuretics including indapamide have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia. If Perindopril/Indapamide/Amlodipine is prescribed to patients with known or suspected renal artery stenosis, treatment should be started in a hospital setting at a low dose and renal function and potassium levels should be monitored, since some patients have developed a functional renal insufficiency which was reversed when treatment was stopped. A dry cough has been reported with the use of angiotensin converting enzyme inhibitors. If the prescription of an angiotensin converting enzyme inhibitor is still preferred, continuation of treatment may be considered. The risk of hypotension exists in all patients, but particular care should be taken in patients with ischaemic heart disease or cerebral circulatory insufficiency, with treatment being started at a low dose. The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with heart failure should be treated with caution. ACE inhibitors should be used with caution in patients with an obstruction in the outflow tract of the left ventricle. In patients with insulin dependent diabetes mellitus (spontaneous tendency to increased levels of potassium), treatment should be started under medical supervision with a reduced initial dose. As with other angiotensin converting enzyme inhibitors, perindopril is apparently less effective in lowering blood pressure in black patients than in non-black patients, possibly because of a higher prevalence of low-renin states in the black hypertensive population. Angiotensin converting enzyme inhibitors can cause hypotension in cases of anaesthesia, it is therefore recommended that treatment with long-acting angiotensin converting enzyme inhibitors such as perindopril should be discontinued where possible one day before surgery. Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Tendency to gout attacks may be increased in hyperuricaemic patients. Interactions: Concomitant use of ACE inhibitors with sacubitril/valsartan, racecadotril, mTOR inhibitors (e.g. sirolimus, everolimus,
temsirolimus) and gliptins (e.g. linagliptin, saxagliptin, sitagliptin, vildagliptin) may lead to an increased risk for angioedema. Hyperkalaemia may occur in some patients treated with Perindopril/Indapamide/Amlodipine. Some drugs or therapeutic classes may increase the occurrence of hyperkalaemia: aliskiren, potassium salts, potassiumsparing diuretics (e.g. spironolactone, triamterene or amiloride), ACE inhibitors, angiotensin-II receptors antagonists, NSAIDs, heparins, immunosuppressant agents such as ciclosporine or tacrolimus, trimethoprim and cotrimoxazole (trimethoprim/ sulfamethoxazole), as trimethoprim is known to act as a potassium-sparing diuretic like amiloride. The combination of these drugs increases the risk of hyperkalaemia, therefore, the combination of Perindopril/Indapamide/Amlodipine with the abovementioned drugs is not recommended. If concomitant use is indicated, they should be used with caution and with frequent monitoring of serum potassium. Please refer to the SmPC for the full list of known interactions with concomitant products which are either contraindicated, “not recommended”, or “require special care”. Pregnancy and lactation: Not recommended during the first trimester of pregnancy. This medicine is contraindicated during the second and third trimesters of pregnancy. Perindopril/Indapamide/Amlodipine is contraindicated during lactation. A decision should be made whether to discontinue nursing or to discontinue Perindopril/ Indapamide/Amlodipine taking account the importance of this therapy for the patient. Effects on ability to drive and use machines: No studies on the effects of fixed combination of perindopril/indapamide/amlodipine on the ability to drive and use machines have been performed. Perindopril and indapamide have no influence on the ability to drive and use machines but individual reactions related to low blood pressure may occur in some patients. Amlodipine can have minor or moderate influence on the ability to drive and use machines. If patients suffer from dizziness, headache, fatigue, weariness or nausea, the ability to react may be impaired. Adverse reactions: Agranulocytosis, aplastic anaemia, pancytopenia, leukopenia, neutropenia, thrombocytopenia, hypersensitivity, hyperkalaemia, hypokalaemia, syncope, peripheral neuropathy, angina pectoris, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, Torsade de Pointes (potentially fatal), pancreatitis, gastritis, hepatitis, jaundice, pemphigoid, erythema multiforme, Stevens-Johnson Syndrome, exfoliative dermatitis, toxic epidermal necrolysis, rhabdomyolysis, renal failure, electrocardiogram QT prolongation. Common: Dizziness, headache, paraesthesia, dysgeusia, visual impairment, tinnitus, vertigo, hypotension, cough, dyspnoea, abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, pruritus, rash, muscle spasms, asthenia. Consult the Summary of Product Characteristics in relation to other side effects. Overdose: There is no information on over-dosage with fixed combination of perindopril/indapamide/amlodipine in humans. For perindopril/indapamide combination the most likely adverse reaction in cases of overdose is hypotension, sometimes associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion. For amlodipine, experience with intentional overdose in humans is limited. Gross overdosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported. Non-cardiogenic pulmonary oedema has rarely been reported that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Please refer to the SmPC for full guidance on management of overdosage. Legal category: POM. Marketing Authorisation Number: PA1986/108/001-004. Marketing Authorisation Holder: Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands. Job Code: MED-IE-00091. Date of Preparation: January 2025
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com
Date of Preparation: January 2025 | Job Code: GEN-IE-00114