
Fintan Moore looks at what has happened in recent years to throw gravel into the gears of the supply chain SUPPLY AND DEMAND
Fintan Moore looks at what has happened in recent years to throw gravel into the gears of the supply chain SUPPLY AND DEMAND
Colic and constipation are among the top issues that parents are discussing with their healthcare professionals in Ireland1
In a clinical study of formula fed infants with minor GI problems, 95% of paediatricians observed that Cow & Gate Comfort positively improves symptoms of COLIC and CONSTIPATION in infants2. For example: reduced periods of infant crying and an increase in defecations per day.
In a clinical study of formula fed infants with minor GI problems, 95% of paediatricians observed that Cow & Gate Comfort positively improves symptoms of COLIC and CONSTIPATION in infants2 For example: reduced periods of infant crying and an increase in defecations per day.
Our blend of oligosaccharides (scGOS/lcFOS)* is clinically proven to increase bi dobacteria levels and soften stools3-4
Reduced lactose
Fat blend with beta-palmitate
Partially hydrolysed protein (100% whey)
If an infant is changing formula, allow a settling period of up to 14 days. Stools may be softer, looser & greener in colour. It is recommended that a variable ow teat or a single hole teat with medium or fast ow is used.
*Short Chain Galacto-Oligosaccharides/Long Chain Fructo-Oligosaccharides.
*Short Chain Galacto-Oligosaccharides/Long Chain Fructo-Oligosaccharides.
1. Nutricia Research, 2023 (unpublished data on file). 2. Savino F et al. (2003) Acta Paediatr Suppl. 91(441):86-90. 3. Moro G et al. (2002) J Pediatr Gastroenterol Nutr. 34(3):291-295. 4. Schmelzle H et al. (2003) J Pediatr Gastroenterol Nutr. 3;36(3):343-51.
1. Nutricia Research, 2023 (unpublished data on file). 2. Savino F et al. (2003) Acta Paediatr Suppl. 91(441):86-90. 3. Moro G et al. (2002) J Pediatr Gastroenterol Nutr. 34(3):291-295. 4. Schmelzle H et al. (2003) J Pediatr Gastroenterol Nutr. 3;36(3):343-51.
IMPORTANT NOTICE: Breastfeeding is best. Cow & Gate Comfort is a food for special medical purposes for the dietary management of colic & constipation. 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 as part of a balanced diet from 6-12 months. Refer to label for details.
Scan to access parent resources
IMPORTANT NOTICE: Breastfeeding is best. Cow & Gate Comfort is a food for special medical purposes for the dietary management of colic & constipation. 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 as part of a balanced diet from 6-12 months. Refer to label for details.
Nutricia Ireland, Block 1 Deansgrange Business Park, Deansgrange, Co. Dublin
Accurate at time of publication: February 2024
Nutricia Ireland, Block 1 Deansgrange Business Park, Deansgrange, Co. Dublin
Accurate at time of publication: February 2024
This information is intended for healthcare professionals only
resources
Welcome to this month's issue, which we hope will provide some food for thought on some of the issues affecting you.
Inside, you will find a feature on the PSI's latest annual report, which provides some interesting data that may be encouraging for the profession.
In 2023, 524 pharmacists were added to the Register, bringing the total number to 7,483, representing the largest ever single-year increase in first-time registration numbers. Interestingly, the report notes a 165 per cent increase in pharmacists registering from EU countries compared to 2022.
Of those newly-registered pharmacists, just over one-third received their qualification from Irish universities, with one-fifth graduating in the UK.
However, the total number of pharmacies registered increased by only four compared to 2022. Does this mean owning a pharmacy is not the desirable career path that it used to be? The figures perhaps merit further investigation, but let us know what you think.
Engagement with the ePortfolio review process remains high, and the report notes that 97 per cent of selected pharmacists met the standards for ePortfolio Review for 2023/2024.
The PSI also provided Irish Pharmacist with a breakdown of Expressions of Concern, of which 135 were received during 2023. As you might expect, the majority of these were made by members of the public, but 16 per cent were raised by other pharmacist colleagues. Overall, there was a 14 per cent increase in
the number of Expressions of Concern compared to 2022. Whether or not that figure is entwined with the Covid crisis is open to interpretation.
However, regarding formal complaints, the PSI received 73, which represents an increase of 36 per cent versus 2022.
Of the Expressions of Concern, there were only 11 made regarding dispensing errors (six 'incorrect medication', five 'incorrect dose').
Only one was raised under the category of 'Professionalism', but by far the greatest number was under 'Pharmacy practice issues', at 54.
Eleven were raised under 'Behaviour (manner/attitude)', while another four were raised under 'Behaviour' that were not categorised further. Clearly, as has been learned by the medical profession, many complaints are a result of miscommunication or perceived sleights.
In our clinical section, you will find content written by pharmacists, for pharmacists that may enhance your clinical acumen. Among this month's topics are updates on areas such as fatigue, hair and scalp care, and influenza.
You can also earn 2 CPD points by completing our module on gastroenterology, which covers conditions ranging from the benign to the clinically comple x.
Whether you are reading for information, entertainment or to brushup your clinical knowledge, we hope our August issue will provide you with all three in the correct doses.
Pat Kelly
04: News
The latest national and international news in pharmacy
12: Pharmacy matters
The PSI speaks to Irish Pharmacist about some of the figures from its latest annual report
16: Jab satisfaction
The IIOP has announced new online training programmes and resources to support pharmacists with the delivery of the flu vaccine
18: Fintan Moore
What has happened in recent years to clog-up the supply chain?
20: Dr Des Corrigan
Against the backdrop of a ‘blockbuster’ drug, is there a place for natural remedies among the treatment options for metabolic syndrome?
22: Terry Maguire
How ‘bad science’ is too often used to convince even those who think they know 'the science'
24: U lt an M olloy
The joys of ‘jamming’ with printers in the pharmacy can be a cause for stress above and beyond the call of duty
26: Gastroenterology
Earn 2 CPD points by completing our module on a range of gastroenterological conditions, from the simple to the serious
34: Influenza
All about influenza, from prevention to vaccination, including antiviral treatments for high-risk patients and the role of the pharmacist
The conditions that can affect our hair and scalp, as well as the management strategies and treatment options that are available
41: Fatigue
A clinical perspective on chronic fatigue, including possible causes and different types of fatigue
44: Motoring
Dr Alan Moran test-drives the new Mercedes E220D, a quiet but powerful incarnation of a classic
45: News
A round-up of product and industry news
Editor
Pat Kelly, pat@greenx.ie
Subeditor
Elaine Walsh
elaine@greenx.ie
Creative Director
Laura Kenny
laura@greenx.ie
Administration Manager
Daiva Maciunaite, daiva@greenx.ie
Managing Director
Graham Cooke, graham@greenx.ie
GreenCross Publishing was established in 2007.
Publisher and Managing Director: Graham Cooke, graham@greenx.ie
© Copyright GreenCross Publishing Ltd 2024.
The contents of Irish Pharmacist are protected by copyright. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means – electronic, mechanical or photocopy recording or otherwise –whole or in part, in any form whatsoever for advertising or promotional purposes without the prior written permission of the editor or publishers.
Disclaimer
The views expressed in Irish Pharmacist are not necessarily those of the publishers, editor or editorial advisory board. While the publishers, editor and editorial advisory board have taken every care with regard to accuracy of editorial and advertisement contributions, they cannot be held responsible for any errors or omissions contained.
*Ibuprofen soft capsules vs normal release tablets
Easofen Rapid Relief Max Strength 400 mg soft capsules. Each soft capsule contains 400 mg of ibuprofen. Presentation: Oval shaped, soft gelatin capsule containing clear colourless liquid. Indications: In adults and adolescents weighing from 40 kg (12 years and above) for the short-term symptomatic treatment of mild to moderate pain such as headache, period pain, dental pain and fever and pain associated with the common cold. Dosage: Adults and adolescents weighing from 40 kg (12 years and above): Initial dose is one capsule (400 mg). Then, if necessary, additional dose of 400 mg can be taken with the interval of six hours between doses. A total dose of 1,200 mg ibuprofen (three capsules) should not be exceeded in any 24-hour period. Refer to Summary of Product Characteristics for full prescribing information. Method of administration: Oral use. The capsules should be taken with a glass of water. Contraindications: Hypersensitivity to the active substance or any of the excipients. History of hypersensitivity reactions. History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/haemorrhage. Severe hepatic, renal or heart failure. Patients with cerebrovascular or other active bleeding. Patients with unclarified blood-formation disturbances. Severe dehydration. During the last trimester of pregnancy. Warnings and precautions: Caution is required in patients with certain conditions, which may be made worse: systemic lupus erythematosus and mixed connective tissue disease, congenital disorder of porphyrin metabolism, gastrointestinal disorders and chronic inflammatory intestinal disease, hypertension and/or cardiac impairment, renal impairment, hepatic dysfunction, directly after major surgery, in patients who show allergic reactions to other substances, hayfever, nasal polyps, chronic obstructive respiratory disorders or history of allergic disease. The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases risk of adverse reactions and should be avoided. The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding (GI) and perforation which may be fatal. Serious skin reactions, some of them fatal, have been reported very rarely in association with NSAIDs. Caution is required prior to starting treatment in patients with a history of hypertension and/or heart failure. Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely. At the first signs of a hypersensitivity reaction therapy must be stopped. Ibuprofen may temporarily inhibit the blood-platelet function. It is recommended to monitor patients with coagulation disturbances. In prolonged administration of ibuprofen, regular checking of the liver values, kidney function and blood count is required. Through concomitant consumption of alcohol, undesirable effects may be increased on use of NSAIDs. Ibuprofen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. Contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product. Interactions: Concomitant administration of ibuprofen and acetylsalicylic acid, other NSAIDs, digoxin, phenytoin, lithium, corticosteroids, anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs), anticoagulants, probenecid, sulfinpyrazone, diuretics and other antihypertensive drugs, methotrexate, cyclosporine, tacrolimus, zidovudine, sulphonylureas, quinolone antibiotics, mifepristone and CYP2C9 inhibitors. Fertility, pregnancy and lactation: Ibuprofen should not be given during the first and second trimester of pregnancy unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first and second trimester, the dose should be kept as low and duration of treatment as short as possible. Ibuprofen is contraindicated during the third trimester. Ibuprofen appears in the breast milk in very low concentration and unlikely to affect the breast-fed infant adversely. There is some evidence that drugs which inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility. This is reversible on withdrawal of treatment. Driving and operation of machinery: Ibuprofen generally has no or negligible influence on the ability to drive and use machines. Undesirable effects: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been observed. Particularly the risk of gastrointestinal bleeding occurring is dependent on the dose range and the duration of use. Refer to the SmPC for other undesirable effects. A copy of the SmPC is available on request. Pack size: 20 capsules. Marketing authorisation holder: Clonmel Healthcare Ltd. Marketing authorisation number: PA0126/343/001. Legal Class P. Last revision date: August 2023. 2023/ADV/IBU/149H
The Irish Pharmacy Union (IPU) in its pre-budget submission has emphasised the urgent need to address the chronic underfunding of Ireland’s community pharmacy sector and pay community pharmacists an economically viable dispensing fee. Pharmacists are being paid less than they were 20 years ago, the Union pointed out.
IPU President Tom Murray said it has been outlined to the Department of Health that 10 per cent of community pharmacists are operating at a loss, and another 33 per cent are perilously close to becoming unviable based on the inadequate margins they are currently achieving. “The current fee does not cover the costs and in fact, because of the regressive and penal nature of the fee structure, it does not even cover the labour element of the cost.
“Many pharmacists are at breaking point, and community pharmacy is at a tipping point,” he continued. “The Government needs to take note and immediately provide the necessary funding to set this right and pay the €6.50 flat fee the IPU has been seeking. All other healthcare professionals, workers and contractors have had their payments restored since the 2007 financial crisis ended. We need the autumn Budget to address this situation and put community pharmacy back on a viable, safe and fair footing.
“The majority of pharmacies are
small, family-owned and operated healthcare businesses,” Mr Murray explained. “We provide a vital service to the State and our communities by dispensing medicines under community drug schemes. This revenue accounts for approximately 60 per cent of the average pharmacy’s income. It is no longer viable to administer these schemes without the fee increase. Over the last 20 years, costs have increased significantly, particularly in the past four-to-five years. Community pharmacists effectively spend 82 per cent of their time working on the Community Drugs Scheme and are doing so at a loss. Some pharmacies are having to reduce their opening hours, while a lot of pharmacists are working extensive hours in order to make ends meet.
“The IPU is calling for the introduction
of a core dispensing fee of €6.50 for each medication dispensed under the community drug schemes. The current outdated structure of reducing fees based on the volume dispensed in each pharmacy must be discontinued. Our costs do not decrease with higher volumes, and neither should the payments we receive.”
He also highlighted concerns about the increased administrative burden pharmacies face, saying there has been a dramatic increase in the level of administration and compliance requirements over the years, and this is impacting patient care time. Streamlining and rationalisation must happen, as time spent on out-of-date administration schemes is not adding value to the patient, the State, or the pharmacist, he said. Until such time as administrative burdens are removed from the pharmacists, a €1.50 administration fee per item dispensed will be required to compensate the pharmacy.
Concluding, Mr Murray said: “There is a huge need for expanded pharmacybased healthcare and community pharmacists have the expertise to deliver it, as evidenced by the Covid vaccine programmes and access to emergency contraception, but this expanded role will only be possible if and when pharmacy is put back on a sure financial footing.”
Irish scientists led by a group from Trinity College Dublin have discovered how the dangerous respiratory syncytial virus (RSV) defuses our immune response and, in doing so, they have pinpointed an exciting new target for drug developers.
RSV causes a significant disease burden in the global population, with an estimated 33.1 million cases each year, and is the leading cause of infant bronchiolitis and viral pneumonia. It is also particularly problematic for children and elderly people, with treatment options limited and relatively ineffective. Some RSV vaccines have recently been approved in Europe, but are not currently available through the HSE in Ireland.
Working with human airway
Panadol Actifast Lemon 500mg
Soluble Tablets (paracetamol)
• Can start to relieve pain from 15 minutes
• Dissolves in water to create a lemon-flavour solution
Absorbed up to 2x faster than standard paracetamol tablets
• An alternative for patients who don’t like the taste of unflavoured soluble tablets
Find out how Panadol Actifast
500mg Soluble Tablets can help your patients
Product Information:
Please consult the summary of product characteristics for full product information.
Panadol Actifast Lemon 500 mg Soluble Tablets (paracetamol) Indications: Short-term management of symptoms of headaches, musculoskeletal disorders, menstrual pain, toothache, colds and flu, as well as symptomatic relief of mild to moderate pain associated with doctor-diagnosed osteoarthritis. Dosage: Adults (including the elderly) and children 16 years and over: 1-2 tablets up to 4 times daily, as required. Children aged 10-15 years: 1 tablet up to 4 times daily, as required. Max 4 doses in 24 hours. Do not give to children for more than 3 days without consulting a doctor. Do not give to children under 10 years. Minimum dosing interval: 4 hours. Contraindications: Hypersensitivity to paracetamol or any of the other ingredients. Precautions: Do not use with any other paracetamol-containing products. Use with caution in patients with glutathione depleted states, those with risk factors for hepatotoxicity (see SPC for list). Caution, due to paracetamol, if administered with flucloxacillin due to increased risk of high anion gap metabolic acidosis. Contains: 427 mg sodium per tablet, use with caution in those on a low sodium diet. 50 mg sorbitol per tablet Patients with hereditary fructose intolerance should not take this medicinal product. Side e ects: All very rare: Thrombocytopaenia, hypersensitivity reactions including anaphylaxis, skin rash, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, serious skin reactions, bronchospasm, hepatic dysfunction. MA Holder: Haleon Ireland Limited, 12 Riverwalk, CityWest Business Campus, Dublin 24. MA Number: PA 678/39/17. Legal Category: Pharmacy Only. Text revised: January 2024. Further information available on request. Contains Paracetamol. Always read the label/leaflet.
Trade marks are owned by or licensed to the Haleon group of companies. PM-IE-PAN-24-00008
epithelial cells, the team of scientists has discovered that RSV suppresses a key biological pathway in our cells (the JAK/STAT pathway) and prevents key immune system igniters from moving into the nuclei of cells. These igniters are ordinarily activated by interferon-alpha, our own natural antiviral.
Prof Nigel Stevenson, Assistant Professor of Virology Immunology in Trinity’s School of Biochemistry and Immunology, is the senior author of the research article that has just been published in leading journal Frontiers in Immunology. Nigel, who is based in the Trinity Biomedical Sciences Institute
(TBSI), said: “Interferon-alpha, which activates signals in our cells through the JAK/STAT pathway, is responsible for kick-starting hundreds of antiviral genes into action, which then target the virus in a number of different ways. So when RSV prevents interferon from communicating to these genes, the virus 'slams the brakes' on our immune response, which can result in the virus taking hold and quite quickly causing very serious medical issues.
“Our discovery is an exciting revelation because it identifies the JAK/ STAT pathway as a prime target for therapeutic immune restoration. And
this new knowledge is very valuable to drug designers, as they need to fully understand how a virus evades our immune system before they can successfully create a therapeutic to turn the tide.
“We predict such a therapeutic could make a significant impact in treating RSV and even clear an RSV infection, which would represent a much-needed solution for both children and the elderly, who are very vulnerable to this dangerous virus.”
The research article can be read Open Access at: https://doi.org/10.3389/ fimmu.2024.1395809.
Electrical currents may make body’s cancer-killing cells even better
Scientists have discovered that electrical currents may make natural killer (NK) cells — our very own cancer-killing immune cells — even better 'killers', which could have significant implications for treating some cancers.
The scientists found that tumour treating fields (TTF) in the laboratory (which mimic exposure of brain tumours to electric currents via a simple hat worn by patients) evoked an even more deadly response from NK cells. They hope their promising findings may open the door to new combined therapies for people living with certain brain tumours, such as glioblastoma.
Glioblastoma is an aggressive, common brain cancer that has a very poor prognosis for survival. Treatment may involve surgery combined with chemotherapy and radiation therapy, but the cancer often returns. Consequently, new approaches are urgently required.
In the new study, which has just been published in leading journal Cell Reports Physical Science, the team of scientists explored whether TTF devices would impact the efficacy of NK cells, which
are used as an immunotherapy to treat some cancers. The team was led by Prof Clair Gardiner, Professor in Immunology in Trinity’s School of Biochemistry and Immunology, in collaboration with Prof George Malliaras, an engineer in the University of Cambridge.
Prof Gardiner said: “Immunotherapies have improved outcomes for a large range of cancer types and offer significant potential for hard-to-treat cancers; however, it is likely that a
combination of treatment approaches will ultimately be required for maximum impact on patient outcomes.
“Little is known about whether TTFs can be used successfully in combination with immunotherapies, or even if TTFs might stop immunotherapy from working completely. The findings here, however, are very promising as our work shows that they had minimal negative impact on the NK cells and seemed to make them even more effective as killers.”
Specifically, the team found that exposure to TTFs did not impact NK cell viability or production of cytokines, which are key immunological molecules produced by NK cells. More exciting however was the finding that exposure increased NK cell degranulation, which is a sign of better NK cell killing.
The team now hopes to follow this work up with more in-depth studies, and Prof Gardiner added: “More work is needed, but the data suggest that treatment using a combination of TTF and NK cells could be beneficial, and offer future potential for a new dual-modality treatment for patients with glioblastoma.”
CCF: 26619 Date of preparation: (07-24)
ABBREVIATED PRESCRIBING INFORMATION
Pregnancy and Lactation: Caution in pregnancy due to lack of clinical data. No studies in lactating women, therefore, not recommended during breast-feeding. Ability to Drive and Use
Product Name: Emazole Control 20 mg Gastro-Resistant Tablets
Composition: Each tablet contains 20 mg esomeprazole (as magnesium dihydrate).
Description: Light pink oval lm coated tablet.
tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Emazole Control treatment should be stopped for at least days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of PPI treatment. Contains glucose and sucrose.
Interactions: E ect of esomeprazole on other drugs: Co-administration with atazanavir is not recommended. If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitor ing is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded. Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. Serum levels of cilostazol, cisapride, tacrolimus, methotrexate may be increased. An interaction is observed between clopidogrel and esomeprazole, but the clinical relevance is uncertain. As a precaution, concomitant use esomeprazole and clopidogrel should be discouraged. Gastric acid suppression by PPIs increase or decrease absorption of drugs with pH dependent absorption (decreased absorption ketoconazole, itraconazole); esomeprazole inhibits CYP2C19 metabolising enzyme and could increase plasma concentrations of diazepam, citalopram, imipramine, clomipramine, phenytoin (monitor plasma levels of phenytoin), etc. resulting in need of a dose reduction; monitor INR when given with warfarin or similar. Caution as absorption of digoxin can increase. E ect of other drugs on esomeprazole: CYP2C19 and CYP3A4 inhibitors (clarithromycin, voriconazole) may increase the esomeprazole exposure. Dose adjustment not regularly required, except in severe hepatic impairment and long-term use. CYP2C19 and/or CYP3A4 inducers (rifampicin and St. John’s wort) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism.
immediately or within 15 min, or administer through a gastric the tablets for 2-3 consecutive days to achieve improve discontinued. If no symptom relief is obtained within 2 weeks of function: recurrent vomiting, dysphagia, haematemesis or melaena) and delay diagnosis. Treatment with proton pump patients, also possibly Clostridium di cile. Patients vitamin B12 may be reduced due to hypo- or achlorhydria. Control in cases of subacute cutaneous lupus erythematosyndrome (SJS), toxic epidermal necrolysis (TEN) and should be advised of the signs and symptoms of the symptoms. Do not re-challenge. Interference with laboratory Emazole Control treatment should be stopped for at least 5 should be repeated 14 days after cessation of PPI
Machinery: Minor in uence on the ability to drive or use machines. Adverse reactions such as dizziness (uncommon) and blurred vision (rare) have been reported. If a ected, patients should not drive or use machines. Undesirable E ects: Common: Headache, abdominal pain, constipation, diarrhoea, atulence, nausea/vomiting, fundic gland polyps (benign). Uncommon: Peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, dry mouth, increased liver enzymes, dermatitis, pruritis, rash, urticaria, fracture of the hip, wrist or spine. For other side e ects refer to the SPC.
Indication(s): Proton Pump Inhibitor (PPI): Short-term treatment of re ux symptoms (e.g. heartburn and acid regurgitation) in adults. Dosage: Swallow tablets whole with liquid, do not chew or crush. Disperse in half a glass of non-carbonated water if di culty in swallowing. Stir until tablets disintegrate, drink liquid with pellets immediately or within 15 min, or administer through a gastric tube. Do not chew or crush pellets. Adults: Recommended dose is 20 mg esomeprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Duration of treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. Elderly (≥ 65 years old): As per adults. Paediatric population (< 18 years): Not recommended. No relevant use in this group in the indication: “short-term treatment of re ux symptoms (e.g., heartburn and acid regurgitation)”. Severe impaired renal function: Caution. Severe liver impairment: 20 mg max daily dose. Contraindications: Hypersensitivity to esomeprazole, substituted benzimidazoles or any of the excipients. Not with nel navir. Warnings and Precautions for Use: On demand treatment: Contact a physician if symptoms change in character. In the presence of any alarm symptom (e.g. signi cant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with esomeprazole may alleviate symptoms and delay diagnosis. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium di cile. Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Absorption of vitamin B12 may be reduced due to hypo- or achlorhydria. Not recommended for long-term use as the following may also occur: Hypomagnesaemia; Risk of fracture. Consider stopping Emazole Control in cases of subacute cutaneous lupus erythematosus (SCLE) accompanied by arthralgia. Serious cutaneous adverse reactions (SCARs) such as erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening, have been reported very rarely. Patients should be advised of the signs and symptoms of the severe skin reaction EM/SJS/TEN/DRESS. Discontinue and seek medical advice immediately when observing any indicative signs or symptoms. Do not re-challenge. Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Emazole Control treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of PPI treatment. Contains glucose and sucrose.
with a PPI is judged unavoidable, close clinical monitorshould not be exceeded. Esomeprazole is a CYP2C19 should be considered. Serum levels of cilostazol, cisapride, relevance is uncertain. As a precaution, concomitant use of pH dependent absorption (decreased absorption of diazepam, citalopram, imipramine, clomipramine, phenytoin absorption of digoxin can increase. E ect of other drugs adjustment not regularly required, except in severe hepatic levels by increasing the esomeprazole metabolism. during breast-feeding. Ability to Drive and Use have been reported. If a ected, patients should not vertigo, dry mouth, increased liver enzymes, dermatitis, 0074/100/001. Further information and SPC are available from:
Marketing Authorisation Holder: Rowa Pharmaceuticals Ltd., Newtown, Bantry, Co. Cork. Marketing Authorisation Number: PA 0074/100/001. 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.
Interactions: E ect of esomeprazole on other drugs: Co-administration with atazanavir is not recommended. If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded. Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. Serum levels of cilostazol, cisapride, tacrolimus, methotrexate may be increased. An interaction is observed between clopidogrel and esomeprazole, but the clinical relevance is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged. Gastric acid suppression by PPIs increase or decrease absorption of drugs with pH dependent absorption (decreased absorption of ketoconazole, itraconazole); esomeprazole inhibits CYP2C19 metabolising enzyme and could increase plasma concentrations of diazepam, citalopram, imipramine, clomipramine, phenytoin (monitor plasma levels of phenytoin), etc. resulting in need of a dose reduction; monitor INR when given with warfarin or similar. Caution as absorption of digoxin can increase. E ect of other drugs on esomeprazole: CYP2C19 and CYP3A4 inhibitors (clarithromycin, voriconazole) may increase the esomeprazole exposure. Dose adjustment not regularly required, except in severe hepatic impairment and long-term use. CYP2C19 and/or CYP3A4 inducers (rifampicin and St. John’s wort) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism.
Pregnancy and Lactation: Caution in pregnancy due to lack of clinical data. No studies in lactating women, therefore, not recommended during breast-feeding. Ability to Drive and Use
Date of Preparation: July 2024 CCF for API: 26593
Machinery: Minor in uence on the ability to drive or use machines. Adverse reactions such as dizziness (uncommon) and blurred vision (rare) have been reported. If a ected, patients should not drive or use machines. Undesirable E ects: Common: Headache, abdominal pain, constipation, diarrhoea, atulence, nausea/vomiting, fundic gland polyps (benign). Uncommon: Peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, dry mouth, increased liver enzymes, dermatitis, pruritis, rash, urticaria, fracture of the hip, wrist or spine. For other side e ects refer to the SPC.
Marketing Authorisation Holder: Rowa Pharmaceuticals Ltd., Newtown, Bantry, Co. Cork. Marketing Authorisation Number: PA 0074/100/001. 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: July 2024 CCF for API: 26593
Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie) or by emailing medsafety@hpra.ie or by emailing Rowex pv@rowa-pharma.ie Supply Through Pharmacy Only
medsafety@hpra.ie
Researchers from Trinity College Dublin have taken a leap forward in understanding how we might fight back against the potentially deadly MRSA bacterium. They have shown in an animal model that targeting a key suppressive immune molecule (IL-10) during the delivery of a vaccine improves the ability of the vaccine to protect against infection.
The bacterium Staphylococcus aureus is one of the leading causes of community- and hospital-acquired bacterial infection, and is associated with over one million deaths worldwide each year. Unfortunately, antibiotics are becoming increasingly less effective against this bacterium, with the antibiotic-resistant form, MRSA, responsible for the highest number of deaths in high-income countries that are attributable to antimicrobial resistant bacterial infections.
As a result, scientists are keenly focused on finding solutions to turn the tide in fighting S.aureus-related infections. One hugely appealing option is a vaccine but, while some progress has been made on that front in recent years, a number of major hurdles remain. One of these appears to be the bacterium’s ability to dampen the immune response by turning on one of the natural breaks that exists within the immune system, an important immune-suppressive molecule known as Interleukin-10 (IL-10), which acts to reduce inflammation in the body.
The interesting thing about S.aureus is that in addition to being a deadly pathogen, forms of this bacteria live in and on our bodies without causing harm. During these asymptomatic interactions the bacterium is, however, shaping the immune response — meaning that when a vaccine against S.aureus is administered, the immune system struggles to respond appropriately. Here, in the work just published
in leading journal JCI Insight , the researchers showed in the animal model that if they immunised subjects with a vaccine that primed their immune systems to respond to infection in tandem with antibodies that neutralised IL-10, the immune response (via specialised T-cells) was improved, and bacterial clearance was likewise improved following subsequent infection.
The research team was led by Rachel McLoughlin, Professor in Immunology in Trinity College Dublin’s School of Biochemistry and Immunology. Rachel, who is based in the Trinity Biomedical Sciences Institute, said:
“Taken in combination, our results offer significant promise for what would be a novel strategy for improving the efficacy of vaccines developed with the aim of suppressing S.aureus infection.
“Our work also strongly suggests that prior exposures to this bacterium may create a situation whereby our immune system no longer sees it as a threat and thus does not respond appropriately to a vaccine due to the creation of this immune-suppressed state. Again, this underlines why immunisation delivered with something that helps neutralise IL-10 offers renewed hope for effective vaccines against S.aureus .”
Drug repurposing shows promise in the treatment of retinal degenerations, according to a new study by an international team of researchers, published recently in Nature Communications. A combination treatment incorporating three existing drugs — tamsulosin, metoprolol and bromocriptine — slowed disease progression in preclinical retinopathy models.
The new study focused on drug repurposing in the context of inherited retinal degenerations (IRDs). IRDs are a group of genetic diseases that cause the deterioration of retinal anatomy and function, leading to gradual loss of vision and often blindness. Most IRDs are currently inaccessible therapeutically, comprising an unmet medical need for a substantial population worldwide.
The researchers found that a combination treatment incorporating three drugs significantly slowed disease progression and decreased disease manifestation in four different animal models of IRD. The combination included the blood pressure and heart failure drug metoprolol, and tamsulosin, which is used for the treatment of benign prostatic hyperplasia, as well as the nowadays less commonly used Parkinson’s disease
drug bromocriptine.
“In drug repurposing, it does not matter which diseases or conditions the drugs were originally developed for, but it is the molecular-level effects of drugs, or pharmacology, that count,” says the article’s first-author Dr Henri Leinonen, currently Adjunct Professor of Neuropharmacology at the University of Eastern Finland, and previously Postdoctoral Researcher at the University of California, Irvine.
In retinal degenerations, intracellular secondary messengers such as cyclic adenosine monophosphate and calcium are believed to be overactive, exacerbating the disease. Metoprolol, tamsulosin and bromocriptine suppress the activity of these secondary messengers via their own distinct cell membrane-receptor actions.
“We hypothesised that the combined effect of these drugs would alleviate the disease, which it indeed did in several distinct animal models of IRDs. However, the efficacy and safety of this combination in humans with retinal degeneration is not guaranteed, and controlled clinical trials to test these are needed,” Dr Leinonen notes.
It is noteworthy that none of the drugs used in the study were effective against
retinal degeneration on their own; instead, their combination was necessary for efficacy. According to Dr Leinonen, the same phenomenon may apply to many diseases that are currently untreatable, and especially in multifactorial diseases, effective treatment may require multiple drugs to be used simultaneously.
Rare diseases, IRDs included, are seldom of major interest for the pharmaceutical industry due to a lack of economic incentives. However, drug repurposing, which is an active research topic in academia, is a promising method to find solutions for rare diseases that remain therapeutically inaccessible.
The most significant advantages of drug repurposing can be found in faster drug development times and lower costs. Since repurposed drugs have already undergone several mandatory safety tests and early stages of clinical trials, their market entry is considerably faster and cheaper than that of completely new drugs.
Drug safety is also an important aspect, as the relative safety of repurposed drugs compared to a completely new chemical reduces risks and uncertainty, which is often considered the most critical point in the drug development process.
The HSE has encouraged everyone who takes regular medicines to keep an upto-date list of their current medication by using the HSE’s ‘My Medicines List’. It has also urged pharmacists to share the list with their patients.
Now available in 52 different languages, My Medicines List is a list of all the medicines and supplements a patient takes. As well as helping patients to become familiar with the medications
they take, the HSE said it hopes it will also help healthcare professionals, including pharmacists, to have informed discussions with patients about their medications.
Ciara Kirke, Clinical Lead of the HSE’s National Medication Safety Programme, said: “Having a list of your medicines is so useful. You can use it to keep track of your medicines. You can use it to communicate information about your medication clearly with healthcare
professionals at appointments, or if you’re admitted to hospital. If you haven’t used this list before, you can now watch a video showing you how to use a medicines list. Our team has worked with translators and people in our community to translate the My Medicines List in 52 languages.
“This means that everybody should be able to keep a list that they understand, and use it when they need healthcare,” she continued. “We hope these resources
will be really useful to patients and all those involved in their healthcare, including your pharmacist and GP. We encourage healthcare professionals, agencies and groups to share the list within their communities.”
In terms of what to include, the HSE recommends:
All prescribed and over-the-counter medicines and supplements.
Inhalers, patches, injections, creams, eye drops and any other prescribed products.
Over-the-counter medicines, vitamins and other supplements, herbal, homeopathic or alternative medicines.
Dosage, the amount of medication and the time taken, along with any allergies. It is recommended to keep the list up-todate regularly, as medications or dosages may change.
Dr Orla Healy, National Clinical Director in the HSE’s Quality and Patient Safety
Directorate, said: “Medication safety is a key priority for the HSE, as outlined in the Patient Safety Strategy 2019-2024. Ten per cent of emergency admissions of older adults are related to medication harm. Seventy-one per cent were potentially preventable. At some point in our lives, we all take medications. For those of us who take multiple medications daily, it can become confusing to keep track. Keeping a medicines list is a simple tool, but it has been shown to help reduce medicationrelated harm.”
Bernie O’Reilly of the Patients for Patient Safety Ireland advocacy group said: “As Chair of Patients for Patient Safety Ireland, I recognise the importance of encouraging everyone on medication to keep their own medicines list. Healthcare systems are not seamless and the information we share as individuals contributes to our own safety. The HSE My Medicines List provides
an excellent template, now available in 52 languages. Medication is the most applied intervention in patient care, and an up-to-date medicines list captures vital information for sharing at every healthcare interaction. When the question is, ‘what medication are you taking?’, the answer is ‘I have it listed here on My Medicines List’.”
The lists and video are available on the HSE National Medication Safety Programme website, www.hse.ie/ safermeds. To order copies of blank medicines lists in English, go to www. healthpromotion.ie and search for ‘medicines’.
My Medicines List is part of the HSE’s ongoing Know Check Ask Medication Safety Campaign. This campaign is the public awareness part of the World Health Organisation (WHO) Global Patient Safety Challenge called Medication Without Harm.
Minister for Health Stephen Donnelly has announced that the flu vaccine is being made available free of charge to all those over 60 years of age and to children aged two-to-17 years for the seasonal flu vaccination programme for 2024/2025.
Children aged two and over will be eligible for the nasal spray flu vaccine. This is a safe, quick and pain-free way to protect children from flu in winter. The vaccine also reduces the risk of children transmitting infection to others, including older, more vulnerable people.
An injectable vaccine will be available for other eligible groups, including those aged 60 and over, individuals with certain health conditions, and healthcare workers.
Minister Donnelly said: “I am very pleased to announce an extension to the seasonal flu vaccination programme, which will see the free flu vaccine
offered to all those over 60 years of age in 2024/2025.
“Children aged between two and 17 will also be able to avail of a free nasal flu vaccine. This measure will help to ensure that those who are most vulnerable to the effects of flu will be offered protection, free of charge.
“The expansion of this programme is particularly important when we consider the pressure that flu cases and hospitalisations place on our healthcare service, so I encourage everyone who is eligible for the vaccine to take up the offer once the programme commences.”
Acting Chief Medical Officer Dr Colette Bonner said: “Vaccination is the most effective means of protection that we can employ to safeguard ourselves and the vulnerable people in our communities. By making the seasonal flu vaccine available free of charge to all adults from 60 years of age, we are helping to protect the population against flu and to reduce its spread in the community. This extension is intended to further limit the burden on our health services for flu-related illnesses over the winter months.”
Not all topical diclofenac products are the same. Formulation Matters.1
Strength
is clinically proven to demonstrate deep tissue penetration into the joint 2
Learn more about the formulation of Voltarol Emulgel Extra Strength Gel
† apply once, morning & evening
References: 1. Derry S et al. Cochrane Database Syst Rev 2015; 6: CD007402. 2. Seefried et al. Ther Adv Musculoskel Dis (2020) Vol 12: 1-13. Product Information: Please consult the Summary of Product Characteristics for full product information. Voltarol Emulgel 1% w/w Gel (diclofenac) and Voltarol Emulgel Extra Strength 2% w/w Gel (diclofenac). Indications: For the local symptomatic relief of pain and inflammation in trauma of tendons, ligaments, muscles and joints, localised forms of soft tissue rheumatism. Dosage: Adults and adolescents 14 years and over: Voltarol Emulgel 1% w/w Gel: 2-4g of gel, applied topically 3-4 times daily. Maximum treatment duration is 7 days. Voltarol Emulgel Extra Strength 2% w/w Gel: 2-4g of gel, applied topically 2 times daily – morning and evening. Maximum treatment duration is 14 days. All gels: Patients should consult their doctor if the condition does not improve within 7 days, or worsens. Contraindications: Patients with or without chronic asthma in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents. Hypersensitivity to diclofenac, acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, or any other ingredient in the gel. Use in third trimester of pregnancy. Use in children and adolescents aged less than 14 years. Warnings and precautions: Apply only to intact, non-diseased skin and not to skin wounds or open injuries. Do not smoke and avoid naked flames. It should not be used with occlusion, allowed to come into contact with the eyes or mucous membranes or ingested. Application over extensive areas for prolonged periods or application in excess of recommended dosage may give rise to systemic effects. Discontinue if rash develops. Use with caution in patients with a history of peptic ulcers, gastrointestinal bleeding, hepatic or renal insufficiency, or bleeding diathesis, or intestinal inflammation. Voltarol Emulgel 1% w/w Gel: Contains propylene glycol and benzyl benzoate, which may cause skin irritation. Voltarol Emulgel Extra Strength 2% w/w Gel: Contains propylene glycol and butylhydroxytoluene which may cause skin reactions or irritations, and fragrance limonene and linalool which may cause allergic reactions. Side effects: Very rare: rash pustular, hypersensitivity (including urticaria), angioedema, asthma, photosensitivity reaction. Rare: Dermatitis bullous. Common: Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus. MA Holder: Haleon Ireland Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. MA Number: Voltarol 1% w/w Gel: PA 678/140/2. Voltarol 2% w/w Gel: PA 678/140/3. Legal Category: 1%: GSL, 2%: Pharmacy only. Text revised: July 2023. Further information available on request. Contains diclofenac diethylammonium. Always read the label/leaflet. Trade marks are owned by or licensed to the Haleon group of companies. PM-IE-VOLT-23-00025.
The PSI tells Irish Pharmacist about the highlights of its latest annual report, as well as the mechanics of the Expression of Concern process
The PSI has published its Annual Report and Financial Statements for 2023, outlining the work undertaken by the pharmacy regulator to protect the health, safety, and wellbeing of patients and the public by regulating pharmacists and pharmacies in Ireland.
The Society says its main activities included:
Being invited to be a representative of the Expert Taskforce to Support the Expansion of the Role of Pharmacy in Ireland.
Publishing the Workforce Intelligence Report, the first report of its kind for pharmacy in Ireland.
Adding 524 pharmacists to the Register, bringing the total number to 7,483, representing the largest ever single-year increase in first-time registration numbers.
Carrying out 143 risk-based pharmacy inspections.
Reviewing 135 expressions of concern about pharmacists and pharmacies.
Receiving 73 formal complaints, an increase of 36 per cent on 2022.
Hosting five regional roadshows as part of an ongoing commitment to engaging with registrants on patient safety and quality initiatives.
Launching a revised Core Competency Framework for Pharmacists.
Publishing a review of the CPD model in place for pharmacists and a report setting out a recommended CPD model for pharmaceutical assistants.
Launching the next phase of the PSI Business Transformation Project.
Commenting on the publication of the Annual Report, PSI Registrar and Chief Officer Joanne Kissane said: “Last year
marked a period of considerable progress for the PSI, as we advanced a number of our strategic objectives, as set out in our Corporate Strategy 2021-2024.
“The establishment of the Expert Taskforce by the Minister for Health to Support the Expansion of the Role of Pharmacy marked one of the most significant developments for pharmacy in Ireland in 2023. The expansion of the role of pharmacists in the public interest has been a strategic focus for the PSI Council and the Department of Health for some time. Our participation in the Expert Taskforce aligns with our objective to expand the role of pharmacy as part of an integrated healthcare system so that pharmacists can make an enhanced contribution to improving patient outcomes and accessibility,” she commented.
The first recommendation of the Taskforce was accepted by the Minister for Health in November 2023. Under the recommendation, pharmacists are enabled to extend the validity of a prescription from six months up to a maximum period of 12 months if, in their professional judgement, it is safe and appropriate to do so. Prescribers are also enabled to issue prescriptions for up to 12 months. This recommendation is the first step in expanding the role of pharmacists in Ireland with the aim of improving patient access, streamlining healthcare delivery at the lowest point of complexity, and contributing to better patient outcomes, in line with the principles of Sláintecare, said the Society. September 2023 saw the publication of the Workforce Intelligence Report, providing a baseline view of the pharmacy workforce in Ireland. The report was commissioned to assess emerging risks to the continued availability of a professional pharmacy workforce in both community and hospital settings. It sheds light on the challenges experienced in relation to pharmacist recruitment and retention, incorporating insights from pharmacists and pharmacy students that will be used to support strategic workforce planning. The report identified six recommendations, each underpinned by a number of actions, and a commitment from stakeholders, including the PSI, to implement these actions to secure a future sustainable pharmacist workforce.
Speaking to Irish Pharmacist (IP) about the highlights of the Report, the PSI said:
“The establishment of the Expert Taskforce by the Minister for Health to Support the Expansion of the Role of Pharmacy marked one of the most significant developments for pharmacy in Ireland in 2023.
“The expansion of the role of pharmacists in the public interest has been a strategic focus for the PSI Council and the Department of Health for some time. The PSI’s participation in the Expert Taskforce aligns with our objective to expand the role of pharmacy as part of an integrated healthcare system, so that pharmacists can make an enhanced contribution to improving patient outcomes and accessibility.”
It also cited the publication of the Workforce Intelligence Report as notable. “The publication of the Workforce Intelligence Report was also a significant development. It is the first report of its kind for pharmacy in Ireland, providing a baseline view of the pharmacy workforce in Ireland. A key priority is the implementation of the recommendations and actions in the Workforce Intelligence Report, which will significantly impact pharmacy and the role of pharmacists in patient-facing settings. The PSI remains committed to working with stakeholders across the system to advance this important work,” the Society told IP
Registration figures are also noteworthy. Of particular interest is the year-on-year increase in the number of pharmacists added to the PSI register. In 2023, 524 pharmacists were added to the Register, bringing the total number to 7,483, representing the largest ever single-year increase in first-time registration numbers.
Of those newly-registered pharmacists, just over one-third received their qualification from Irish universities, with one-fifth graduating in the UK. Additionally, there was a 165 per cent increase in pharmacists registering from EU countries compared to 2022. The total number of pharmacies registered was 1,985, an increase of four from 2022.
“Implementing the recommendations and actions in the Workforce Intelligence Report will significantly impact pharmacy and the role of pharmacists in patient-
facing settings. Achieving these recommendations will require extensive collaboration, and we remain committed to working with stakeholders across the system to advance this important work,” said the Society.
The ePortfolio reviews have also been a matter of interest since The Irish Institute of Pharmacy (IIOP) was established by the PSI in 2013 to oversee the development and management of the Continuing Professional Development (CPD) system for pharmacists in Ireland.
The PSI told IP that engagement with the system remains high. “ePortfolio review first commenced in 2017 and has operated every year since then. The guidelines that support ePortfolio Review are set out in the IIOP ePortfolio Review Policy, which is reviewed annually by the IIOP and approved by the PSI Council thereafter. Standards for ePortfolio Review are updated and developed in consultation with peer pharmacists.
“The standards incorporate two elements; System Based Standards, and Review Standards. All submitted extracts are reviewed against the System Based Standards by the IIOP ePortfolio System, and a sample of extracts are also reviewed against the Review Standards by a reviewer. The IIOP updates the supporting resources and information on ePortfolio Review for pharmacists every year on the IIOP website.
“Engagement levels with the ePortfolio review process continue to remain high, with 97 per cent of selected pharmacists meeting the standards for ePortfolio Review 2023/2024. The outcomes of the process were communicated by the IIOP to all pharmacists on 30 April 2024,” the Society told IP
A robust and transparent process to facilitate the public and pharmacy profession to raise concerns and bring forward complaints is a key pillar of the pharmacy regulator’s work, the PSI added. During 2023, a total of 135
expressions of concern were received, a 14 per cent increase from 2022. Of these, 39 per cent related to pharmacy practice issues. The majority of concerns (78 per cent) were raised by members of the public, while 16 per cent were raised by other pharmacists. Additionally, 73 formal complaints about pharmacists or pharmacies were received, marking a 36 per cent increase on the previous year.
The PSI shares information and learning from complaints and the outcomes of inquiries. This is done in the interest of maintaining and upholding professional standards, raising awareness around patient and public safety matters, and promoting compliance with pharmacy and medicines legislation.
“The public is entitled to a high standard of care from pharmacists, and pharmacies must operate at high standards of quality and safety. We continued to uphold these standards through significant registration, inspection and enforcement activities carried out throughout the year. These activities are at the core of what we do and are delivered by highly committed and skilled colleagues from across the organisation,” stated the PSI.
On Expressions of Concern, the PSI was asked by IP to elaborate on the process.
“An expression of concern is whereby a person brings a matter to the attention of the PSI, but does not want to make a formal complaint. In 2023, 79 per cent of all concerns received were from members of the public, while 16 per cent were raised by pharmacists.
“Once received, a multidisciplinary team in the PSI assesses what regulatory action may need to be taken with these, if any. In the event of a concern becoming a complaint, it is at this point that it will be processed under Part 6 of the Pharmacy Act 2007. Of the 135 concerns received in 2023, (a 14 per cent increase on 2022), 39 per cent related to pharmacy practice issues, and six resulted in formal complaints. These are made in writing to the PSI. Formal complaints are processed strictly in line with the provisions of the Pharmacy Act 2007.”
“Once a complaint is received, the PSI processes it and refers it to the Preliminary Proceedings Committee (PPC) for consideration in accordance with the process set out in the Pharmacy Act 2007. The PPC, upon review of the complaint, advises the PSI Council whether there is sufficient cause to warrant further action being taken in relation to the pharmacist/ pharmacy, the subject of the complaint. The PPC can then refer the complaint to either mediation, or for hearing before a statutory Committee of Inquiry.”
The PSI also broke down the nature of the Expressions of Concern for IP, of which there were 135. These were categorised as:
4: Behaviour.
11: Behaviour (manner/attitude).
16: Commercial/advertising/ employment issues.
6: Dispensing error (incorrect medication).
5: Dispensing error (incorrect dose).
2: Dishonesty.
3: Emergency supply issues.
14: Failure to supply.
19: Other.
54: Pharmacy practice issues.
1: Professionalism.
As part of its remit to ensure pharmacists are engaging in continuing professional development (CPD), the PSI commissioned an independent review of the CPD model for pharmacists and developed a proposal for a CPD model for pharmaceutical assistants. A revised Core Competency Framework for Pharmacists was also published.
“Patients and the public expect and deserve high-quality care and service from their pharmacists. The PSI supports this by setting and ensuring standards for education, training, and CPD. We were pleased to launch a revised Core Competency Framework for Pharmacists, which outlines the range of competencies expected of pharmacists in the early stages of their career,” said the Society.
“This framework also supports a number of statutory functions and
provides structure and guidance for all pharmacists when reflecting on their continuing professional development needs. The review of the current CPD model for pharmacists was a significant achievement, containing a number of recommended changes in line with both emerging developments and international best practice in this area.”
The PSI told IP : “Following an independent review of the CPD model for pharmacists in 2022/2023, the PSI Council at its meeting of 14 December 2023 accepted the findings of the Review of the Continuing Professional Development (CPD) Model for Pharmacists in Ireland Report (2023) (The Mazar’s Report) and approved the recommendations therein.
The review of the current CPD model for pharmacists was a significant achievement
“To further inform and elaborate on the Council’s consideration on the scope of the revised CPD model for pharmacists, an implementation proposal was developed to provide an evidencebased framework to implement the recommendations contained within the Mazar’s Report. This implementation proposal was approved by the PSI Council at its meeting of 25 April 2024. Work continues on implementing the approved changes to the CPD model for pharmacists. Further information is available on the PSI website.”
The annual report highlights and commends the participation of pharmacists in both public health and information and awareness campaigns, with more than 1,300 community pharmacies participating in the autumn/ winter vaccination campaign. In 2023, progress continued on the PSI Business
Transformation Programme, aimed at enhancing ways of working across the PSI and ensuring it optimises use of technology and colleagues’ time and expertise in the best way possible. This multi-annual project is delivering a new digital platform for the PSI to provide a single customer view of all relevant registrant and risk-related data. In 2023, as part of this initiative, an online registration platform for completing Internet Supply List applications and an updated searchable Internet supply list were launched.
“Our work to assure continued trust in the safety and quality of pharmacy is a central part of all activity,” the PSI told IP. “Core to this is the operation of a robust, fair and transparent service to facilitate the public and the profession to bring forward complaints. In addition, registration, inspection and enforcement activities carried out throughout the year ensure that high standards are maintained across the profession and that the public are provided with a high quality and standard of care, which they are fully entitled to and expect.
“To this point, the completion of 143 risk-based pharmacy inspections, coupled with the review of 135 expressions of concern about a pharmacist or pharmacy and the processing of 73 complaints, were important developments, demonstrating our commitment to ensuring the highest standards are maintained. It is important to highlight that we share information and learnings from complaints and from the outcomes of inquiries, with the objective of ensuring learnings are applied, to enhance future care, and crucially for the benefit of patients and the public.
“This past year has seen the progression of several strategic projects which will continue to shape the future of pharmacy in Ireland,” the Society stated. “We are pleased that advances have been made under our strategic objectives to assure continued trust in pharmacy. We look forward to delivering on our commitments in 2024 and to engaging positively and constructively with all stakeholders.” ●
pharmacist before use with any other medication. Antacids may interact with certain medications. Patients with renal or hepatic impairment should consult a physician before using Pepcid Duo Chewable Tablets. In case of renal failure, monitoring of serum magnesium and calcium should be undertaken. Pepcid Duo is contraindicated in patients with severe renal failure. As some serious underlying conditions can have symptoms in common with simple indigestion, it is recommended patients seek medical advice in case of: indigestion symptoms accompanied by unintentional weight loss, difficulty swallowing, persistent abdominal discomfort, heartburn occurring for the
The Irish Institute of Pharmacy (IIOP) has announced the availability of new online training programmes and resources to support pharmacists with the delivery and administration of the seasonal influenza vaccine
New resources are available on the IIOP website to keep pharmacists up-to-date in relation to the Recommendations of the Expert Taskforce to Support the Expansion of the Role of Pharmacy. A dedicated section of the Resource Hub contains information and links to useful websites. A suite of resources has also been developed specifically to support pharmacists in the implementation of Recommendation 1 - Prescription Extension, which comes into effect from 1 September.
Seasonal influenza vaccines: New resources
Ahead of the upcoming influenza season, pharmacists will be able to enrol on the following courses via the IIOP website:
Delivery of a Pharmacy-Based Vaccination Service.
Responding to an Emergency Situation, including the Management of Anaphylaxis (RESMA).
Administration of influenza vaccine 2024/2025.
To register, pharmacists should log into the IIOP website, click on the ‘Courses and Events’ page and select the ‘Vaccination Training’ tab.
Ensuring up-to-date training
In order to administer the seasonal influenza vaccine to adults and children from six months old, there are five training programmes in total, listed below, which pharmacists must complete. Each training programme has a specific validity period. Pharmacists should verify both the date on their certificate of completion and the programme validity, as outlined on the Pharmaceutical Society of Ireland (PSI) website.
Phase 1: Empowering pharmacists to extend prescriptions
On foot of recommendations made by the Expert Taskforce for the Expansion of the Role of Pharmacy, from 1 September, new legislation will come into effect allowing pharmacists to extend and dispense certain prescriptions written on or after 1 March 2024 from six months up to a maximum of 12 months where appropriate. The IIOP is providing a suite of resources designed to help pharmacists meet the requirements of Recommendation 1 -
Training Programme Training Provider Where to complete CPR (Adults and Children) Cardiac First Response Community Level or Heartsaver® CPR AED AHA Contact training provider directly for details
Parenteral Medicines Administration Training (PAMT)
Responding to an Emergency Situation and Management Of Anaphylaxis (RESMA)
Delivery of a Pharmacy-Based Vaccination Service (DPBVS)
Administration of the Influenza Vaccination (2024/25)
Hibernian Healthcare Register on the Hibernian Healthcare website
Hibernian Healthcare Register on the IIOP website
Hibernian Healthcare Register on the IIOP website
Hibernian Healthcare Register on the IIOP website
Prescription Extension. These resources will include case studies, decision making tools and support resources.
In addition, the following events are scheduled for the Autumn:
‘In Conversation With...’ Webinar: August 28, 2024, to introduce the new suite of resources.
‘In Conversation With...’ Webinar: September 11, 2024, to discuss practical implementation of Phase 1 Recommendations.
Interactive Workshops: Three online workshops throughout autumn will provide practical application through case studies, directed at enhancing pharmacists' skills and confidence.
For further information on any of the above training programmes and workshops, visit the dedicated ‘Expert Taskforce Information and Resources’ section of the Resource Hub on the IIOP Website.
Phase 2: Empowering pharmacists to prescribe within their scope of practice
Additionally, a dedicated section has been created on the IIOP Resource Hub to provide information relating to the Pharmacy Expert Taskforce Phase 2 recommendations. Search for IIOP Resource Hub, Expert Taskforce, or enter the following link into your browser: https://iiop.ie/content/expert-taskforce.
How to stay connected with IIOP: Keep an eye on your emails for latest updates.
Subscribe to the IIOP newsletter — past newsletters are available on the IIOP website.
IIOP Website, ‘Resource Hub’ and ‘Latest News’ sections.
See our social media platforms, including X (formerly Twitter), LinkedIn and Instagram. For any queries, contact info@iiop.ie. ●
Fintan Moore looks at what has happened in recent years to throw gravel into the gears of the supply chain
Many years ago, a friend of mine was so exasperated by the unreliability of so many tradesmen (pretty much exclusively men in those days) that he said, ‘you can make money doing anything in this country just by not being a piss-artist’. And he was sadly correct. All it took for any tradesman to be immediately seen as a cut above the rest was to turn up on the agreed day, at the right time, with the required tools and supplies. This basic level of reliability and courtesy catapulted him into the equivalent of a five-star rating before ratings existed, and his phone number would be passed on to friends and family with the reverence befitting that of a healing charm in a medieval plague. Pharmacists, in contrast, were generally regarded as being good service providers most of the time. There have always been complaints from people about having to wait for prescriptions to be ready, and that’s unlikely to ever change, but for the most part we’ve been seen as trustworthy and reliable. However, I think it’s getting more and more difficult for the profession to maintain that standard. In recent months I’ve gained new patients who left their previous pharmacies because they weren’t happy with the level of service, and the problems related mostly to stock not being available when it should have been.
This is a basic requirement of a pharmacy, but it’s been getting harder to keep ticking all the boxes, and these patients moved when their expectations weren’t met. Before I come over as
sounding like a paragon of goldstandard service, I hasten to add that it’s entirely possible I’ve also lost patients for the same reasons, but just haven’t yet realised that they’re missing.
So what’s changed in recent years to throw so much gravel in the gears of our supply chain? There is no one single issue responsible, but rather a number of different straws that have combined to break the camel’s back.
In no particular order:
The service levels from the main wholesalers aren’t as good as they used to be because the cut-off times for ordering have got earlier, and Saturday deliveries no longer exist for second-line accounts.
The High-Tech Hub has made ordering more cumbersome, and often delays can arise if a query gets raised — I accept that these are expensive products and the Hub is a necessary evil to reduce wastage, but that doesn’t stop it being a problem.
The number of out-of-stock products at any given time makes it impossible to maintain a smooth service. Even crucial items like Salbutamol Nebules have been missing for several weeks. We’re also constantly having to switch
The introduction of the ‘10-day rule’ was an act of near-criminal stupidity, but it’s not going to go away
generics as different companies run into supply shortages.
Even more frustrating than products being missing completely is the issue of products being ‘on allocation’ or subject to some other Byzantine protocol that sees my pharmacy completely starved of supply, while other pharmacies have enough stock for both their own patients and mine.
The ‘10-day rule’ on return of products creates the problem of pharmacies deciding to hold less stock and order items when needed, but this leaves them open to the risk that the items might be unavailable when the time comes. The introduction of the ‘10-day rule’ was an act of nearcriminal stupidity, but it’s not going to go away.
There is an ever-growing number of unlicensed or unusual medicines requiring a specific ordering process to be carried out, often from specialist suppliers, which adds to the risk of the staff in a busy pharmacy simply forgetting to follow through on requests. Or the other issue that can arise is that some companies rely for deliveries on courier companies that don’t always hire the world’s smartest van drivers, so it’s not unknown for parcels to get delayed.
When you weigh-up all the ways that things can go wrong, it’s surprising that we keep as many patients as we do.
There are occasions when it doesn’t make sense to upgrade a piece of equipment that is still working, even if
it’s a bit past its best. Then there are other times when you do the maths and realise that a newer, faster machine will pay for itself surprisingly quickly.
As a case in point, I’ve got a scanner linked to each of my dispensing computers. One scanner is fast and always ready to use. The other has a power-down standby mode that it takes about 30 seconds to wake up from, and I’ve developed an almost
irrational dislike for this scanner because of that delay.
I’ve crunched the numbers and reckon this repeated waste of 30 seconds adds up to a daily waste of four minutes, or an annual waste of 20 hours. Even at minimum wage, that’s about €300 wasted, which is exactly what a new scanner costs. So I’ve ordered a new one that should pay its way in about a year, and make me a happier, more productive pharmacist
much sooner than that, as I no longer have to hover, waiting for the current one to drag itself back from the land of nod. ●
Fintan Moore graduated as a pharmacist in 1990 from TCD and currently runs a pharmacy in Clondalkin. His email address is: greenparkpharmacy @gmail.com
Against the backdrop of a ‘blockbuster’ drug, Dr Des Corrigan wonders whether there is a place for natural remedies among the treatment options for metabolic syndrome
The controversy over the proper role of semaglutide in clinical practice seems to be intensifying, if a recent Saturday opinion piece in The Irish Times is anything to go by. In it, a leading expert on obesity treatment was critical of an Irish Medical Council stand restricting use of a low-dose formulation (Ozempic) to diabetics only, and not to treat obesity, citing reduced availability and a lack of evidence of efficacy in obesity.
Whatever about the former, the latter point seems strange because at the time of the Medical Council diktat in 2022, the EMA formally approved the use of Semaglutide in the form of Wegovy as an adjunct to a reduced-calorie diet and increased physical exercise for weight management in obese or overweight adults and adolescents. Indeed, many clinicians see semaglutide as a game-changer in responding to the various health challenges presented by metabolic syndrome.
That syndrome involves at least three metabolic disease abnormalities, such as dyslipidaemia greater than 150mg/ dl; HDL-cholesterol less than 40mg in men or 50mg in women; hypertension greater than 130/85mmHg; impaired fasting glucose greater than 110mg/ dl; and a waist circumference greater than 102cm in men or 88 in women. Its prevalence has increased (because of dietary and lifestyle changes) to 20-to-25 per cent of the population, not only in the developed world, but also in developing countries. Deaths
due to chronic heart disease linked to dyslipidaemia are estimated to climb to 24 million worldwide by 2030.
Because of cost and availability issues surrounding Semaglutide, it is likely that many in both the developed and developing worlds will be looking at herbal products as a possible alternative though more accessible treatments. I have written about some
such herbs and spices a year or two ago, but felt it opportune to update that information for you.
I want to start with a herb of which you may not have heard, called Sumac. Though I had come across the name, I knew nothing about it until I was treated to a salmon fillet that had been covered with a Sumac paste before cooking, while on a visit to Sydney
a few years ago. I have to say that it was the nicest salmon I have ever tasted because of the citrussy flavour from the Sumac, and I can thoroughly recommend it to you if you want to try it for yourself.
So, I was pleasantly surprised when I came across a systematic review and meta-analysis of the effects of Sumac supplementation on lipid profile. The dried crimson-coloured fruits of Sumac from a species of Rhus are widely used as a spice in the Middle East and North Africa because of the tart lemony taste. If the name Rhus seems familiar to you, it is probably because poison ivy was originally known botanically as Rhus toxicodendron , but is now a separate species called Toxicodendron radicans .
The review appeared in Phytotherapy Research earlier this year and included seven RCTs involving 570 subjects. Sumac supplementation decreased total cholesterol, LDL-cholesterol and triglycerides and significantly increased HDL-cholesterol. Such increases were greater in studies lasting longer than 12 weeks.
Saffron, a spice about which I had written in 2022, was the subject of an updated systematic review and meta-analysis in the Journal of Ethnopharmacology a few months ago. Both saffron and its major constituent crocin were used in the treatment of type-2 diabetes. The review included 15 RCTs involving 600 patients and found that extracts decreased HbA1c, fasting blood glucose (FBG), creatinine and total cholesterol levels, as well as systolic blood pressure, but had no effect on diastolic BP, triglycerides or cholesterol fractions. Crocin also decreased HbA1c, FBG and systolic BP, but creatinine levels increased. Powdered saffron decreased AST but not ALT levels, and BMI increased. Given that saffron is the world’s most expensive spice, it is hard to justify a major medicinal role for it, even if there are multitudinous products on the market already.
I am never certain as to whether
I should refer to garlic as a herb or a spice, but like saffron, there are numerous products based on garlic available as food supplements. The EMA lists it as a traditional herbal medicinal product (THMP) used for the relief of symptoms of the common cold, but more importantly, given the clinical data, as a THMP for use as an adjuvant for the prevention of atherosclerosis.
A systematic review and metaanalysis of studies of the effect of garlic extract on markers of lipid metabolism and inflammation in coronary artery disease (CAD) patients appeared in Phytotherapy Research in
Both saffron and its major constituent crocin were used in the treatment of type-2 diabetes
2023. Both powdered garlic bulb and aged garlic extract were included in the RCTs reviewed. Aged garlic is prepared by soaking sliced raw garlic at room temperature for up to 20 months in aqueous ethanol (15-to-20 per cent).
Whereas the bulb contains the wellknown smelly sulphur-containing allicin that has been shown to be antisclerotic, the aged extract’s main component is another equally pongy sulphur derivative S-allylcysteine with the ability to inhibit cholesterol synthesis.
The meta-analysis found statistically significant changes in HDL, LDL, Apolipoprotein-A, C-Reactive Protein (CRP), Interleukin-6 (IL-6), homocysteine and the Coronary Artery Calcium Score that gives a measure of the degree of calcification in coronary arteries. A more recent (2024) review in the Journal of Ethnopharmacology specifically looked at the effects of garlic on the components of metabolic syndrome. This systematic review and
associated meta-analysis included 34 RCTs involving 2,471 participants and reported significant changes in waist circumference, total cholesterol, LDLand HDL-lipoproteins, triglycerides, BP, Homeostatic Model Assessment for Insulin Resistance, CRP, TNF- α and IL-6. The authors concluded that garlic could decrease the risk factors associated with metabolic syndrome by lowering BP, glucose and lipid levels. They suggested that it could also reduce the inflammation that is a major concern in the progression of the syndrome.
The existence of a ‘blockbuster’ medication such as Semaglutide makes it difficult to see any major role for ‘natural’ alternatives if health systems evolve to allow the more widespread use of the former. However, if supply is restricted, then some will inevitably look for more accessible and less-expensive therapies, especially in those developing countries faced with increased levels of obesity and a shrinking health budget. ●
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 looks at how ‘bad science’ is too often used to convince even those who think they know 'the science'
Back in the early years of the new millennium, I was invited to join an elite group called The UK Pain Management Advisory Board, or some such grandiose title. A PR company I worked for, on and off, made the approach and I quickly said ‘yes’, since to get such an invite was a great boost to my young and naive ego. Me being asked to advise a major pharmaceutical company on pain management and being remunerated handsomely suggested my stock was high — or so I thought.
And so, over the next two years, I attended about six meetings with a small select group consisting of pain consultants, GPs, nurses, and pharmacists. Meetings were held in the most auspicious of venues — on one occasion we met in the boardroom of the Royal College of Surgeons in London, with wood-panelled walls hung with huge portraits of past Presidents. Our task was simple: To work towards a consensus statement on pain management for the UK. For reasons unclear to me then, we failed to reach that agreed consensus and the project just seemed to fall away.
The ‘Ad Board’ — which is how those in the business referred to us — were given research papers to study and presentations from experts at meetings. It was made clear to us that there was, in the UK and around the globe, an epidemic of unmet need in the management of chronic pain. Healthcare professionals were failing
their patients by not addressing this, and a key problem was our irrational fear of opiate addiction. This, we were told, was unfounded. Opiates were not, after all, the nasty habitforming drugs of myth but, when used appropriately, were the solution to chronic pain, that unmet clinical need.
We were given three key scientific facts which were pressed home to us at every possible opportunity during our discussions:
Less than 1 per cent of people treated with opiates become addicted;
Patients in pain do not become addicted to opiates (opiates are only addictive if used recreationally in people without pain);
Slow-release formulations significantly reduce opiate addiction, as they avoid the highs and lows associated with reward and punishment, and which are also linked with addiction.
These scientific facts were new to most of the Ad Board; well, certainly to me. Many of the pain consultants and the pharmacists, including myself, were unconvinced. A nationally known doctor, who was also a professor of clinical pharmacology, was brought into one of our final meetings to present a lecture on the fact that patients in pain, due to sensitivity of their mu opiate receptors, were unlikely to become addicted. Opiates, he assured us, citing a body of published work, were not addictive in chronic
pain sufferers — opiates only block pain, they don’t give the ‘high’.
I remember the difficult silence at the last meeting when both the doctors and pharmacists refused to accept that the addictive potential of opiates is extremely low in chronic pain patients. The consensus statement must acknowledge, we insisted, a reference
to the potential for addiction in some patients. That, it seems, was not what our benefactor wanted.
I was reminded of these meetings while reading Dreamland: The True Story of America’s Opiate Epidemic by investigative journalist Sam Quinones which details US opiate deaths, estimated to number about 600,000 over 15 years.
In Dreamland , Sam Quinones blames the massive rise in oxycodone use in the early years of the millennium squarely on marketing that tricked doctors to change their prescribing practice for pain. This was based on professional consensus statements. Sam identifies these same three scientific facts as the basis of this change. Quinones is not the first author to identify the much-overstated figure that less than 1 per cent of pain patients get addicted to opiates as the key to understanding why so many opiate deaths are now happening in the US. So where did the ‘less than 1 per cent’ figure come from?
The basis of this figure is a short letter to the Editor of the New England Journal of Medicine ( NEJM ) published in January 1980. It was written by Hershel Jick, a doctor at Boston University School of Medicine. Dr Jick had developed a drug database of hospital-based patients which he hoped to use, and subsequently did use, to publish research on inpatients’ drugs. This database still exists and today is known as The Boston Collaborative Drug Surveillance Programme.
Back in 1980 Dr Jick, with graduate student Jane Porter, who did the calculations for the letter, was wondering about useful ways he could use the data — and the letter to the NEJM was a first test. They observed that only four out of 12,000 hospital patients — mostly those suffering acute pain due to injury or surgery and who were treated with opiates — continued to use opiate medications
when they left hospital. This is certainly an interesting observation, but the limits are instantly obvious. The letter — consisting of a single paragraph — did not distinguish between acute and chronic pain, did not identify the opiates used, or for how long, and at what doses.
It really was shocking to see this letter as the basis for the longaccepted scientific fact that less than 1 per cent of patients treated with opiates become addicted. Our Ad Board never saw this paper and it wasn’t readily available before the era of research databases.
In the 1980s, the palliative care movement was keen to make better use of opiates in end-of-life care
In the 1980s, the palliative care movement was keen to make better use of opiates in end-of-life care. Some of their leaders used this paper in their publications, so the letter became cited in other papers by eminent clinicians that were further cited and, in this way, it became an accepted scientific fact. A fact that PR agencies on behalf of large pharmaceutical companies were later able to spin and spin and, in the end, convince US doctors that prescribing opiates was no bad thing at all but a necessary good thing.
The other two facts were equally spurious. The idea that patients in pain have different sensitivity on the mu opiate receptors is largely theoretical with no science to support the idea that addiction is less likely.
The use of slow-release formulations likewise is theoretical
and is borrowed from other studies on other drugs that show more rapid delivery of a potentially addictive drug leads to higher levels of addiction — think coca leaves versus crack cocaine. So, the three scientific facts are not scientific facts at all, but instead spin from marketing companies working for drug companies.
My benefactor back in 2002 was Napp Pharmaceuticals, which had invented the MS Contin slow-release drug delivery system and first applied it to theophylline and then to morphine sulphate, giving rise to the successful MST brand. It would of course be then applied to oxycodone in OxyContin. In 1966, Napp had become a fully-owned subsidiary of Purdue Pharma, the company responsible for the marketing of OxyContin in the US and the subsequent unacceptable loss of lives there. In 2002, Purdue were calling the shots at Napp. That has changed with the break-up of Purdue Pharma, and Napp now fully accepts and supports the need for careful use of opiates in the management of pain.
I am not suggesting for a moment that our Ad Board stopped a similar opiate problem in the UK. Far from it, we were just lucky that we stood our ground but equally, we could have agreed to the consensus. Certainly, the UK does not have the profit-based healthcare system that the US has, and which exposed it to the egregious marketing that was core to the problem. Bad science is too often used to convince even those who think they know the science. ●
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.
Ultan Molloy reflects on the joys of ‘jamming’ with printers in the pharmacy and the concept of innovation in the profession
So we have a commitment from the HSE to move away from our present OKI blue paper printers for receipt-printing lauded as progress in the last week or so. When we are spending circa €500 on printer consumables, paper and ink presently, the prospect of spending more doesn't feel or sound like it’s going to progress our bottom line in any significant way.
I remember the ‘blue printer breaking down’ on me on a locum in Riverstown in Sligo, not long after returning from the UK. It was pension day, I wasn't very familiar with the Irish schemes or the dispensing computer system and having accepted the locum, I assumed there would be at least one other staff member there with me.
Not the case. I nearly had a nervous breakdown. The repeated jamming of the OKI receipt printer was the icing on the cake. We have gotten to know one another over the years — the blue printer and myself, that is — with the usual cause of jamming being a tiny scrap of paper that has fallen into the working parts of the printer, which can be easily rectified. They're relatively trouble-free once they're set up and running, and shaken out and Hoovered on a frequent basis. So I'm not feeling like I can yet celebrate this change as progress.
‘Innovation’ is a word that's fired around a lot, and interchanged with the words ‘concept’ or ‘progress’, isn't it? To innovate is to make changes to something that is established, especially by introducing new
methods, ideas or products, according to our friend Google. It can be a costly journey in terms of time, finances, and other resources, and making changes for the sake of making changes can often be tantamount to folly.
We will see how the recentlyestablished pharmacy working group gets on in due course. I've already given my tuppence worth on how
We will see how the recently-established pharmacy working group gets on in due course
extending prescription validity will lead to further disjointed patient care in the community, discrepancies in GP and pharmacy records, and is potentially dangerous for patients, given pharmacists are not usually privy to the clinical reasoning for the use of particular medicines on a patient-by-patient basis. We already have one surgery auto-inserting ‘DO NOT EXTEND PRESCRIPTION’ as a default beside every item they prescribe. I suspect others may follow suit, if they were to think it through and want to keep track of what their patients are taking in real time, and want to have them back for regular
and appropriate monitoring associated with the medicines they are on, and indeed for ongoing health screening.
I took a call on Saturday last from a lady who is looking to "find the pain points", and innovate to offer a data-driven solution to community pharmacies as a new business. We spoke through medicine shortages, increasing costs across the board, skilled staff cover and HR, FEMPI cuts, as well as purchasing and maintaining margins. There are a number of pain points indeed, so I hope that she can find opportunities for us to address some of these, although I could not provide her with an idea of where to start that we hadn't looked at already.
I'm sure I have blind spots, and wish her the best, as I've said, so we'll see. "Can the communication between the GPs and yourselves be improved, for example?" she asked. I stopped myself from saying "What communication?", although we aren't doing too bad at all by some people’s experience in terms of communication with GP surgeries. I believe we are supposed to discuss prescription queries directly with GPs by law, and yet we have one lead GP who "doesn't take calls from pharmacies", and so we have had to go through secretarial staff since 2007. We had so many errors coming across on prescriptions from another surgery many years back preHealthmail that I took to pnc'ing them on the paper copies of the script one week (rather than spending time on the phone, where there was little
appetite for correcting the patient records to prevent a recurrence), and faxing them back to the surgery with notes requesting them to update their records. We were subsequently admonished for "clogging up their fax
machine". Like that's what I wanted to achieve, rather than accurate patient records for patient safety and care. Go figure. Ah, the joys of it. Anyway, we'll find out soon enough if the Department of Health has
taken on board any of the recommendations in the IPU's pre-budget submission. Talk about ‘negotiating’ with one hand tied behind one’s back. While there are patients who can't get a GP still, I suspect the number petitioning their local politicians because they can't get a pharmacy is much lower. The number of pharmacies closing seems to have slowed down, prescription volumes nationally are increasing, and the cost of pharmacist cover seems to have reduced. It is difficult to predict the future, but the outcomes of the consultation (not negotiation) process with the Minister and Department of Health, and the recommendations of the MoH-appointed working group, will be interesting to see in the coming months. Hopefully some resourcing of the sector and some useful change and innovation in the sector will transpire. Pharmacies and community pharmacists continue to be a valuable national resource on a walk-in basis, with thousands of people daily, when it can take weeks now to get a GP appointment. The sector appears to have weathered FEMPI and the turbulence of the last 10-plus years now. Let’s hope that the future brightens for the pharmacists joining the community into the future, and our communities can see and benefit from a well-resourced healthcare sector going forward. ●
Ultan Molloy is a business and professional performance coach, pharmacist, facilitator, and development specialist. He works with other pharmacists, business owners, and third parties to develop business strategies. Ultan can be contacted on 086 169 3343.
Many GI issues can be extremely troublesome and have life-long consequences. However, research and treatments are constantly evolving in this area. After reading this module, it is expected the reader will have an enhanced understanding of certain GI conditions, how preventative measures can help, and the diagnostic and treatment options for some of these illnesses.
AUTHOR: Damien O'Brien MPSI
COMPLETE THIS MODULE ONLINE
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.
Introduction
Gastroenterology is the branch of medicine that focuses on the digestive system and the conditions associated with it. The function of the digestive system is to move material through the gastrointestinal (GI) tract via peristalsis, process the food, absorb nutrients, and remove waste from the body. The main components of the digestive system are the mouth, oesophagus, stomach, small intestine, large intestine (colon), rectum and anus. The gallbladder, liver and
pancreas are also organs that are vital for digestion.1
The GI tract is made up of several components that have certain functions. The mouth is the entry point of the digestive system where mechanical digestion begins. Chemical digestion, through enzymes in the saliva, also begins to occur. The mouth also lubricates food with mucus and saliva.
The oesophagus is a muscular tube that moves food from the mouth to the stomach via peristalsis. The stomach is a muscular organ that further helps mechanically and chemically digest food. The muscular layer of the stomach assists in mixing and churning, which are important in the mechanical digestion of food. Food is also mixed with hydrochloric acid and digestive enzymes, which helps break food down into a semi-liquid form called chyme.1
The small intestine has villi, each with multiple microvilli, which increase surface area for nutrient absorption. There is an extensive network of capillaries that optimise absorption. The intestine also has exocrine and endocrine glands that produce hormones and enzymes. The small intestine consists of three parts
— the duodenum, jejunum and ileum. The large intestine has the function of absorbing electrolytes and water from indigestible food to form solid waste called faeces. The rectum and anus are where faeces are stored and then eliminated from the body.1
The liver, pancreas and gallbladder are other organs that are important in the digestive process. The liver produces bile, which is important in digesting and absorbing fats. The gallbladder stores bile and releases it into the small intestine as required. The pancreas produces enzymes and hormones, such as insulin.1
There are several preventive strategies that are vital in GI health and many lifestyle modifications that individuals can make to manage digestive symptoms. Many foods and drinks can irritate the GI tract and trigger conditions such as gastroesophageal reflux disease (GERD), coeliac disease, and inflammatory bowel disease (IBD). These foods can include gluten, acidic, spicy and fatty foods. Dietary modifications, including minimising alcohol and caffeine intake, can improve the management of these conditions. A balanced diet, rich in fruits, vegetables and fibre, with limited red meats can improve GI health. Furthermore, smoking cessation can improve GI health. Maintaining a healthy weight is also important in improving the management of many conditions, and regular exercise can help with this. 2
Vaccination can also help prevent certain disorders in gastroenterology. Vaccination against hepatitis A and B viruses can prevent liver infections, while the human papillomavirus (HPV) vaccination can reduce the risk of HPV-related cancers, including anal and liver cancer.
Screening and surveillance are important for early detection of conditions, as well as regular monitoring of patients with certain conditions.2 A bowel screening service is available for 59-to-61 year-old individuals in Ireland. Individuals
will receive a home screening test, with the objective of early detection of bowel cancer before symptoms are present.3
GERD is a condition that develops due to retrograde flow of the contents of the stomach back into the oesophagus. It is a very common disorder, with a prevalence of approximately 20 per cent. It can be classified into three different types: Non-erosive reflux disease, erosive oesophagitis, and Barrett’s oesophagus. There is no known cause of GERD, but many different mechanisms have been identified that cause the oesophagus to be exposed to acidic gastric contents. Anatomical factors such as hiatal hernia or increased intra-abdominal pressure are associated with an increase in GERD. Motor abnormalities such as impaired oesophageal acid clearance, impairment in the tone of the lower oesophageal sphincter, and delayed gastric emptying are also associated with GERD.
Risk factors for GERD include obesity, increasing age, tobacco use, excessive consumption of alcohol, pregnancy, and medications, including non-steroidal anti-inflammatory drugs (NSAIDs), anticholinergics, benzodiazepines and calcium channel blockers. GERD presents with typical symptoms of heartburn and regurgitation, while atypical and extraoesophageal symptoms include chronic cough, chest pain, dental erosions, laryngitis and asthma. 4
There is no gold standard test in the diagnosis of GERD. The diagnosis is usually made based on presenting symptoms or in combination with other methods, including responsiveness to therapy, esophagogastroduodenoscopy, or ambulatory reflux monitoring. GERD may be diagnosed in most cases when a patient presents with typical symptoms of heartburn and regurgitation. If there are no warning symptoms, the patient may be initiated on empiric therapy. Esophagogastroduodenoscopy may
be used if the patient has one or more warning symptoms, which include dysphagia, anaemia, weight loss and hematemesis. Ambulatory reflux monitoring may be used if the patient does not respond to treatment.
Lifestyle modifications are an important aspect of GERD treatment. Patients should be counselled on the importance of maintaining a healthy weight, as this can reduce GERD symptoms. Avoiding meals for at least three hours before sleeping and maintaining good sleep hygiene are also important points. Diet modifications, including reducing caffeine, chocolate and spicy foods may help some individuals, but the evidence is inconclusive.
Pharmacological treatment may be initiated in patients who don’t respond to lifestyle modifications. Proton pump inhibitor (PPI) therapy is the cornerstone of pharmacological treatment. PPIs have been shown to improve symptoms and heal esophagitis. They work by inhibiting the H+/K+ ATPase proton pump in the stomach and therefore inhibit acid secretion. Patients should be initiated on once-daily dosing on an empty stomach, at least 30 minutes before the first meal of the day. Patients who don’t fully respond to treatment may be treated with twice-daily dosing.
Omeprazole, lansoprazole, pantoprazole, rabeprazole and esomeprazole are all examples of PPIs. Histamine 2 receptor antagonists, such as famotidine and cimetidine, may also be used to treat GERD. These may be used as add-on therapy if symptoms are not fully resolved with maximal PPI therapy. Antacids are a group of drugs that include salts of calcium, magnesium and aluminium as active ingredients. They neutralise stomach acid, but use is restricted to relieving mild symptoms of GERD. 4,5
IBD is a group of autoimmune conditions that are characterised by repeated episodes of inflammation of the GI tract. IBD consists of two separate conditions — Crohn’s disease (CD) and ulcerative
Q1. Chemical digestion of food begins in the stomach.
True or false?
Q2. Histamine 2 receptor antagonists are the first-line treatment of GERD. True or false?
Q3. Antacids, including salts of calcium, magnesium and aluminium as active ingredients, are the firstline treatment of GERD.
True or false?
Q4. Ulcerative colitis is characterised by continuous inflammation in the colon and rectum.
True or false?
Q5. Corticosteroids have a role in treating flare-ups of IBD.
True or false?
Q6. NSAIDs are the leading cause of peptic ulcer disease.
True or false?
Q7. Urea breath testing is used in diagnosing the presence of Helicobacter pylori.
True or false?
Q8. Coeliac disease can be treated pharmacologically with ursodeoxycholic acid.
True or false?
Q9. Acute cholecystitis can present as jaundice.
True or false?
Q10. The cause of GERD has been clinically established.
True or false?
colitis (UC). The exact aetiology of IBD is unknown, but genetics plays a role. Extraintestinal manifestations of IBD can include arthritis, osteoporosis, uveitis, and ankylosing spondyloarthropathy.
CD and UC share similarities, but they also differ in many ways. CD can affect any part of the GI tract, from the mouth to the anus. Symptoms are commonly in the intestine, but symptoms can also affect the mouth, oesophagus and stomach. Inflammation in CD is noncontinuous, with healthy patches of tissues often present between lesions. On the other hand, UC only affects the colon and rectum, while the inflammation is continuous with no healthy areas between lesions.
Symptoms of CD and UC include diarrhoea, abdominal pain, rectal bleeding and weight loss. UC is associated with blood or mucus in the stool, rectal bleeding and tenesmus. Rectal bleeding is not as common in CD, but anal fistula is common. Malnutrition and weight loss are more common in CD due to the fact that damage to the small intestine can reduce absorption of nutrients.
The diagnosis of IBD is based on a combination of clinical findings, inflammatory laboratory markers, imaging findings and endoscopic biopsies. Laboratory blood testing can show raised erythrocyte sedimentation rates and white cell counts, which are associated with intestinal inflammation. Imaging techniques such as ultrasound, computed tomography (CT) scans and magnetic resonance imaging (MRI) are also useful in the diagnosis of IBD or to assess for intraabdomen complications. Endoscopy evaluation is necessary to obtain a biopsy to confirm diagnosis of IBD. 6
There is no pharmacological or surgical cure for IBD, with the treatment objectives to reduce symptoms of the disease and induce remission. Treatment will depend on the disease severity, presence of extraintestinal manifestations, and the portion of the GI tract affected. A stepwise approach is required for IBD
management, and treatment for flareups may also be necessary.
Aminosalicylates are often used in treating IBD, with mesalazine and sulfasalazine commonly used for treating mild-to-moderate disease. These drugs can be administered either orally or rectally. The exact mechanism of aminosalicylates is not fully clear, but it is thought that they reduce the synthesis of prostaglandin and leukotriene, which modulates the inflammatory response. Immunomodulators can also be used to treat IBD and include thiopurines, methotrexate, and calcineurin inhibitors.
Anti-tumour necrosis factor therapy and antiinterleukin therapy are the two main categories of biologic agents used to treat IBD
These immunomodulators all have different mechanisms of action but generally work by reducing the immune response by inhibiting T-lymphocyte proliferation and activation. Azathioprine and 6-mercaptopurine are thiopurines that are effective in treating IBD. Methotrexate is effective in achieving remission in CD patients, but is not as effective in UC.
Calcineurin inhibitors, such as ciclosporine and tacrolimus, can also be effective in achieving remission in patients with IBD. These drugs don’t have a favourable adverse effect profile, which can include bone marrow suppression, liver damage, renal damage and gastrointestinal intolerance. The adverse effect profile of these drugs has led to a move towards biologics in treating IBD. 6 Biologic drugs are often initiated in patients with moderate-to-severe disease. Biologic therapy is often introduced earlier in high-risk patients and patients with severe disease, with
de-escalation possible when a clinical response is observed. Biologics can be effective in treating IBD and have the advantages of reduced toxicity, high selectivity, and high efficiency when compared to other therapeutic options. 8
Anti-tumour necrosis factor (TNF) therapy and anti-interleukin (IL) therapy are the two main categories of biologic agents used to treat IBD. TNF and IL are cytokines that can cause chronic inflammation in the GI tract. Infliximab and adalimumab are examples of antiTNF therapy, while ustekinumab is a commonly used anti-IL agent. Biologics are administered parenterally. The main adverse effects associated with biologic therapy include increased risk of infection, congestive heart disease, malignancies, cardiovascular events and skin reactions.
Corticosteroids can be a useful treatment option if other therapies have failed, or in the case of flare-ups. They are effective in reducing inflammation and inducing remission. Corticosteroids can also be used both orally and rectally, with rectal administration reducing the chance of systemic adverse effects. Surgical intervention can also be used in certain cases, either as monotherapy or in combination with pharmacological treatment. The main indications include heavy bleeding, intestinal perforation, carcinogenesis and highly suspected carcinogenesis. Surgery may also be used in patients with severe IBD who have not responded to medical treatment or can’t tolerate medical treatment. 6
Irritable bowel syndrome (IBS) is a functional disorder characterised by the presence of abdominal pain or discomfort, accompanied by altered bowel habits. IBS is more commonly diagnosed in females than males, with a decrease in prevalence observed with age.
IBS can be classified into three main categories: IBS with constipation (IBS-C), IBS with diarrhoea (IBS-D), and IBS with mixed bowel patterns (IBS-M). The aetiology of IBS is not fully understood, with brain-gut interaction, visceral sensation, motility
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
and psychosocial distress all potential causes. Environmental factors that may contribute to IBS include life stress, enteric infections, food intolerance, and antibiotic use.
The main symptoms of IBS typically include abdominal pain or discomfort, constipation, diarrhoea and altered bowel habits. Other symptoms can include bloating and distention. Diagnosis of IBS can be difficult, but the Rome IV criteria is a validated tool to aid diagnosis. If symptoms are typical of IBS and no warning symptoms are present, routine diagnostic testing may not be required. If warning symptoms are present, further investigations may be necessary. Diagnosis criteria require at least three days per month in the last three months associated with at least two of the following:
Improvement in abdominal pain or discomfort with defecation.
Onset associated with a change in frequency of stool.
Onset accompanied by a change in appearance of stool.7
Treatment objectives are aimed at relieving symptoms of pain, cramping, diarrhoea and constipation. A wide range of fibre supplements and laxatives are available both over the counter and on prescription for treating constipation, including stimulant laxatives (bisacodyl and sennosides), bulk forming laxatives (ispaghula husk), and osmotic laxatives (macrogol and lactulose).
In patients with diarrhoea, loperamide is an opioid receptor agonist and decreases the frequency of diarrhoea, without crossing the blood-brain barrier. Mebeverine hydrochloride, hyoscine butylbromide and alverine citrate can be used for the relief of gastrointestinal spasm in IBS. Peppermint oil is generally a safe treatment option and can be effective for symptoms of discomfort and distension.
Patients with chronic symptoms may respond to low-dose tricyclic antidepressants or SSRIs. Rifaximin has also been shown to be effective in treating IBS. Rifaximin is a broad-
spectrum antibiotic that is not well absorbed, which allows it to work locally in the gut. The effectiveness of rifaximin gives support to the theory that bacterial overgrowth plays a role in the aetiology of IBS. 7
Peptic ulcer disease (PUD) is a condition characterised by discontinuation in the inner lining of the GI tract due to secretion of gastric acid or pepsin. It usually presents in the stomach and proximal duodenum, but may involve the lower oesophagus, distal duodenum or jejunum. There are several potential causes of PUD, with Helicobacter pylori and NSAID use the two most common causes. Less-common causes of PUD include Zollinger-Ellison syndrome, viral infection, CD, radiation therapy, chemotherapy and malignancy. H.pylorus is a gram-negative bacterium that is found within the gastric epithelial cells and is responsible for up to 90 per cent of GI ulcers. Symptoms of PUD include epigastric abdominal pain, bloating, nausea, vomiting, hematemesis and abdominal fullness. Epigastric pain will usually occur within 30 minutes following a meal with a gastric ulcer, while the pain will usually occur two-tothree hours after a meal with a duodenal ulcer. Warning symptoms can include weight loss, GI bleeding, anaemia, emesis, progressive dysphagia, and family history of upper GI malignancy. Diagnosis of PUD is based on patient history and various medical tests. Esophagogastroduodenoscopy is the gold standard in diagnosing PUD, with specificity and sensitivity up to 90 per cent. H.Pylori testing through serologic testing or urea breath testing is useful in diagnosing the presence of the bacterium. Similarly to GERD, PPIs are the cornerstone of treatment of PUD. They have replaced histamine 2 receptor antagonists due to their superior symptom relief and promotion of healing. PUD due to NSAID use can be treated by withdrawal of the NSAID or reducing the dose. Anticoagulants, bisphosphonates and corticosteroids
may also be withdrawn if possible. Firstline treatment for H.pylori -induced PUD is a triple-therapy regimen consisting of two antibiotics and a PPI, which work synergistically against H.Pylori Clarithromycin 500mg every 12 hours, amoxicillin 1g every 12 hours and a PPI every 12 hours is the first-line treatment option. Bismuth may be added for quadruple therapy, while metronidazole may be used in the case of penicillin allergy. Surgery is indicated if the patient does not respond to medical treatment or is at high risk of complications. 8
Coeliac disease is an autoimmune disease of the small intestine, where the body’s immune system reacts with gluten to cause inflammation and damage to the small intestine. It is a genetic disease and is triggered by exposure to gluten in the diet in susceptible individuals. The local inflammation leads to destruction of the villi in the small intestine. This leads to a decrease in the function of the small intestine and impaired nutrient absorption, leading to malnutrition. This can impact on all body systems and result in general poor health.
Common symptoms include lethargy, diarrhoea, constipation, vomiting, abdominal distension, abdominal pain and failure to thrive. Serological tests are generally one of the first steps involved in diagnosis. A duodenal mucosal biopsy, showing villous atrophy, is the gold standard for diagnosis. Coeliac disease is a chronic disorder, with a strict gluten-free diet the only recommended treatment. 9
Gallstones, also known as cholelithiasis, are stones that are formed in the gallbladder composed of cholesterol, bilirubin and bile. Gallstones are usually formed from the slow emptying of bile from the gall bladder. Biliary obstruction from a variety of causes can lead to impaired draining, which can cause bile to precipitate as sludge and develop into gallstones. The most common cause is the precipitation of cholesterol from cholesterol-rich bile. Risk factors for gallstones include obesity, pregnancy,
certain medications, metabolic syndrome , and prolonged fasting. In most cases, gallstones are asymptomatic, with 10 per cent of patients developing symptoms within five years, and 20 per cent of patients developing symptoms within 20 years of diagnosis. The main symptoms of gallstones include pain in the right upper abdomen after eating greasy or spicy food, nausea, vomiting and epigastric pain.
Acute cholecystitis is inflammation of the gall bladder and can be more severe and present as jaundice. A right-upper quadrant abdominal ultrasound has 90 per cent specificity in diagnosing gallstones. Cholecystectomy is indicated to treat symptomatic gallstones, with laparoscopic the preferred approach. Gallstones can be also treated pharmacologically. Ursodeoxycholic acid can be administered once daily for dissolution of radiolucent gallstones in patients with a functioning gall bladder. This has mixed results, but can
be effective for some patients.10
Pharmacists play a crucial role in the management of GI conditions. They play an important role in patient education, particularly around the proper use of medication, adherence to medication, and lifestyle modifications. Pharmacists also monitor patients to ensure safe and effective use of medications in the treatment of GI conditions.
Many conditions in gastroenterology involve complex drug regimens and pharmacists can help to manage these treatment regimens to improve clinical outcomes for patients, while reducing adverse effects. Pharmacists also collaborate as part of a multidisciplinary team with other healthcare professionals to ensure comprehensive care and continuity of care for patients. The field of gastroenterology will continue to evolve with new treatment options, and pharmacists are ideally placed to continue to provide comprehensive patient-centred care.11,12 ●
Q1. Villi, important for absorption of nutrients, are mainly found in what part of the digestive system?
a) Stomach.
b) Small intestine.
c) Large intestine.
d) Liver.
Q2. What is the class of drug that is the cornerstone of treating GERD?
a) PPIs.
b) Histamine 2 receptor antagonists.
c) Ursodeoxycholic acid.
d) Metoclopramide.
Q3. Which of the following is sometimes added to a triple therapy course of a PPI and two antibiotics to make quadruple therapy?
a) Diphenoxylate/ atropine.
b) Domperidone.
c) Bismuth.
d) Loperamide.
Q4. Which of the following is a stimulant laxative?
A) Bisacodyl.
B) Ispaghula husk.
C) Macrogol.
D) Loperamide.
Q5. Which of the following class of drugs is most likely to cause peptic ulcer disease?
A) Opioids.
B) Benzodiazepines.
C) NSAIDs.
D) Statins.
1. Ogobuiro I, and Tuma F (2023). Physiology, Gastrointestinal. [online] Nih.gov. Available at: https://www.ncbi.nlm.nih.gov/ books/NBK537103/.
2. Hospitals, Y (2023). Preventive Care in Gastroenterology. [online] Yashoda Hospitals. Available at: https://www. yashodahospitals.com/blog/preventive-care-in-gastroenterology/.
3. HSE.ie (nd). Bowel screening - BowelScreen. [online] Available at: https:// www2.hse.ie/conditions/bowel-screening/ screening-information/.
4. Antunes C, Curtis SA, and Aleem A (2023). Gastroesophageal reflux disease. [online] National Library of Medicine. Available at: https:// www.ncbi.nlm.nih.gov/books/NBK441938/.
5. Singh P, and Terrell JM (2023). Antacids. [online] Nih.gov. Available at: https://www. ncbi.nlm.nih.gov/books/NBK526049/.
6. McDowell C, Farooq U, and Haseeb M (2023). Inflammatory Bowel Disease (IBD). [online] PubMed. Available at: https://www. ncbi.nlm.nih.gov/books/NBK470312/.
7. Patel N, and Shackelford K (2022). Irritable Bowel Syndrome. [online] PubMed. Available at: https://www.ncbi.nlm.nih.gov/ books/NBK534810/.
8. Malik TF, Singh K and Gnanapandithan K (2023). Peptic ulcer disease. [online] National Library of Medicine. Available at: https:// www.ncbi.nlm.nih.gov/books/NBK534792/.
9. Posner EB, and Haseeb M (2023). Celiac Disease. [online] PubMed. Available at: https://www.ncbi.nlm.nih.gov/books/ NBK441900/.
10. Tanaja J, and Meer JM (2019). Cholelithiasis. [online] Nih.gov. Available at: https:// www.ncbi.nlm.nih.gov/books/NBK470440/.
11. Choi D, Patel SA, Trivedi I, Rubin DT, Moss AC and Bhat SP (2021). A survey of pharmacists’ roles in gastroenterology and hepatology. 4(10), pp.1280–1286. doi:https:// doi.org/10.1002/jac5.1499.
12. Lupascu F, Herciu LA, Tatarusanu S-M, Vasincu, I-M, and Profire L (2021). The role of the pharmacist in the prevention of gastrointestinal diseases. Romanian Journal of Pharmaceutical Practice, 14(S), pp.7–10. doi:https://doi.org/10.37897/rjphp.2021.s.1.
Amgevita®
awarded for 20mg adalimumab.
Amgevita®
value biologic medicine in a citrate free formulation of adalimumab and is the only BVBM awarded for 20mg adalimumab.
Amgevita®
awarded best value biosimilar medicine in a citrate free formulation of adalimumab by the Medicines Management Programme
awarded best value biosimilar medicine in a citrate free formulation of adalimumab by the Medicines Management Programme
Awarded best value biologic medicine in a citrate free formulation of adalimumab and is the only BVBM awarded for 20mg adalimumab.
AMGEVITA® is injected under the skin (a subcutaneous injection) a specially designed pen called SureClick® or using a pre-filled
AMGEVITA® is injected under the skin (a subcutaneous injection) a specially designed pen called SureClick® or using a pre-filled
injected under the skin (a subcutaneous injection) with designed pen called SureClick® or using a pre-filled syringe.
is injected under the skin (a subcutaneous injection) with designed pen called SureClick® or using a pre-filled syringe.
AMGEVITA® is injected under the skin (a subcutaneous injection) a specially designed pen called SureClick® or using a pre-filled
is injected under the skin (a subcutaneous injection) with designed pen called SureClick® or using a pre-filled syringe.
is injected under the skin (a subcutaneous injection) with designed pen called SureClick® or using a pre-filled syringe.
AMGEVITA® is injected under the skin (a subcutaneous injection) a specially designed pen called SureClick® or using a pre-filled
AMGEVITA® is injected under the skin (a subcutaneous injection) a specially designed pen called SureClick® or using a pre-filled
AMGEVITA® 40mg SureClick® Pre-filled pen
injected under the skin (a subcutaneous injection) with designed pen called SureClick® or using a pre-filled syringe.
You should inject in the tummy, or the tops of your legs (thighs), see diagram below.
You should inject in the tummy, or the tops of your legs (thighs),
AMGEVITA® 40mg SureClick® Pre-filled pen
You should inject in the tummy, or the tops of your legs (thighs),
The medicine travels into your bloodstream to work on the that are inflamed and causing your symptoms.
inject in the tummy, or the tops of your legs (thighs), below.
The medicine travels into your bloodstream to work on the areas that are inflamed and causing your symptoms.
You should inject in the tummy, or the tops of your legs (thighs),
AMGEVITA® 20mg Pre-filled syringe
inject in the tummy, or the tops of your legs (thighs), diagram below.
AMGEVITA® 20mg Pre-filled syringe
inject in the tummy, or the tops of your legs (thighs), diagram below.
The medicine travels into your bloodstream to work on the areas that are inflamed and causing your symptoms.
You should inject in the tummy, or the tops of your legs (thighs), see diagram below.
The medicine travels into your bloodstream to work on the areas that are inflamed and causing your symptoms.
travels into your bloodstream to work on the areas inflamed and causing your symptoms.
inject in the tummy, or the tops of your legs (thighs), diagram below.
medicine travels into your bloodstream to work on the areas inflamed and causing your symptoms.
medicine travels into your bloodstream to work on the areas inflamed and causing your symptoms.
Your doctor, pharmacist or nurse will show you or your parent/carer how to give the injection. It’s important the injection is given correctly for it to work.
Your doctor, pharmacist or nurse will show you or your parent/carer how to give the injection. It’s important the injection is given correctly for it to work.
The medicine travels into your bloodstream to work on the that are inflamed and causing your symptoms.
inject in the tummy, or the tops of your legs (thighs), below.
medicine travels into your bloodstream to work on the areas inflamed and causing your symptoms.
Your doctor, pharmacist or nurse will show you or your parent/carer how to give the injection. It’s important the injection is given correctly for it to work.
Your doctor, pharmacist or nurse will show you or your parent/carer how to give the injection. It’s important the injection is given correctly for it to work.
doctor, pharmacist or nurse will show parent/carer how to give the It’s important the injection is given for it to work.
pharmacist or nurse will show parent/carer how to give the important the injection is given to work.
Your doctor, pharmacist or nurse will show you or your parent/carer how to give the injection. It’s important the injection is given correctly for it to work.
doctor, pharmacist or nurse will show parent/carer how to give the It’s important the injection is given for it to work.
40mg Pre-filled syringe
AMGEVITA 40mg Pre-filled syringe
travels into your bloodstream to work on the areas inflamed and causing your symptoms.
AMGEVITA® 20mg Pre-filled syringe 40mg Pre-filled syringe
AMGEVITA 40mg Pre-filled syringe
doctor, pharmacist or nurse will show parent/carer how to give the It’s important the injection is given for it to work.
You may have the injection in hospital or at home. You can give it to yourself or your parent/carer can do this for you. Usually, the injection is given every 2 weeks, but your doctor may change this to best suit what works for you.
Further information is available on request or in the Summary of Product Characteristics (SmPC) at www.medicines.ie.
©2022 Amgen Inc. All rights reserved.
You may have the injection in hospital or at home. You can give it to yourself or your parent/carer can do this for you. Usually, the injection is given every 2 weeks, but your doctor may change this to best suit what works for you.
You may have the injection in hospital or at home. You can give it to yourself or your parent/carer can do this for you. Usually, the injection is given every 2 weeks, but your doctor may change this to best suit what works for you.
Further information is available on request or in the Summary of Product Characteristics (SmPC) at www.medicines.ie.
IE-AMB-0122-00002. Date of preparation: January 2022.
Legal Category: POM. Marketing Authorisation Numbers:
©2022 Amgen Inc. All rights reserved.
IE-AMB-0122-00002. Date of preparation: January 2022.
You may have the injection in hospital or at home. You can give it to yourself or your parent/carer can do this for you. Usually, the injection is given every 2 weeks, but your doctor may change this to best suit what works for you.
AMGEVITA® 40mg Pre-filled syringe
pharmacist or nurse will show parent/carer how to give the important the injection is given to work.
have the injection in hospital or You can give it to yourself or your parent/carer can do this for you. Usually, the given every 2 weeks, but your change this to best suit what you.
Further information is available on request or in the Summary of Product Characteristics (SmPC) at www.medicines.ie.
Further information is available on request or in the Summary of Product Characteristics (SmPC) at www.medicines.ie.
have the injection in hospital or You can give it to yourself or your parent/carer can do this for you. Usually, the given every 2 weeks, but your change this to best suit what you.
©2022 Amgen Inc. All rights reserved.
have the injection in hospital or You can give it to yourself or your parent/carer can do this for you. Usually, the given every 2 weeks, but your change this to best suit what you.
EU/1/16/1164/001 – 1 pack: AMGEVITA® 20 mg solution for injection in pre-filled syringe
EU/1/16/1164/003 – 2 pack: AMGEVITA® 40 mg solution for injection in pre-filled syringe
Legal Category: POM. Marketing Authorisation Numbers:
IE-AMB-0122-00002. Date of preparation: January 2022.
EU/1/16/1164/007 – 2 pack: AMGEVITA® 40 mg solution for injection in pre-filled pen
Legal Category: POM. Marketing Authorisation Numbers:
©2022 Amgen Inc. All rights reserved.
Adult
• Rheumatoid arthritis
Adult
• Ankylosing spondylitis (AS)
Adult
• Rheumatoid arthritis
• Rheumatoid arthritis
Paediatric
You need to follow the advice of your healthcare team and ask to speak to them if you are not feeling well.
EU/1/16/1164/001 – 1 pack: AMGEVITA 20 mg solution for injection in pre-filled syringe
Marketing Authorisation Holder: Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands.
IE-AMB-0122-00002. Date of preparation: January 2022.
EU/1/16/1164/001 – 1 pack: AMGEVITA 20 mg solution for injection in pre-filled syringe
EU/1/16/1164/003 – 2 pack: AMGEVITA® 40 mg solution for injection in pre-filled syringe
EU/1/16/1164/003 – 2 pack: AMGEVITA 40 mg solution for injection in pre-filled syringe
Legal Category: POM. Marketing Authorisation Numbers:
EU/1/16/1164/007 – 2 pack: AMGEVITA® 40 mg solution for injection in pre-filled pen
EU/1/16/1164/007 – 2 pack: AMGEVITA 40 mg solution for injection in pre-filled pen
EU/1/16/1164/001 – 1 pack: AMGEVITA 20 mg solution for injection in pre-filled syringe
• Axial spondyloarthritis without radiographic evidence of AS
Adult
• Ankylosing spondylitis (AS)
• Ankylosing spondylitis (AS)
• Psoriatic arthritis
• Rheumatoid arthritis
You need to follow the advice of your healthcare team and ask to speak to them if you are not feeling well.
Paediatric
• Polyarticular juvenile idiopathic arthritis (JIA) (from 2 years of age)
Paediatric
You need to follow the advice of your healthcare team and ask to speak to them if you are not feeling well.
Marketing Authorisation Holder: Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands.
EU/1/16/1164/003 – 2 pack: AMGEVITA 40 mg solution for injection in pre-filled syringe
EU/1/16/1164/007 – 2 pack: AMGEVITA 40 mg solution for injection in pre-filled pen
Adverse reactions /events should be reported to the Health Products Regulatory Authority (HPRA) using the available methods via www.hpra.ie. Adverse reactions/events should also be reported to Amgen Limited on +44 (0) 1223 436441 or Freephone 1800 535 160.
You may have the injection in hospital or at home. You can give it to yourself or your parent/carer can do this for you. Usually, the injection is given every 2 weeks, but your doctor may change this to best suit what works for you.
• Enthesitis-related arthritis (from 6 years of age)
Marketing Authorisation Holder: Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands.
You need to follow the advice of your healthcare team and ask to speak to them if you are not feeling well.
Marketing Authorisation Holder: Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands.
to follow the advice of your team and ask to speak to them not feeling well.
©2022 Amgen Inc. All rights reserved.
the injection in hospital or can give it to yourself or your can do this for you. Usually, the given every 2 weeks, but your change this to best suit what
Further information is available on request or in the Summary of Product Characteristics (SmPC) at www.medicines.ie.
References:
IE-AMB-0122-00002. Date of preparation: January 2022.
Legal Category: POM. Marketing Authorisation Numbers:
• Polyarticular juvenile idiopathic arthritis (JIA) (from 2 years of age)
• Polyarticular juvenile idiopathic arthritis (JIA) (from 2 years of age)
Further information is available on request or in the Summary of Product Characteristics (SmPC) at www.medicines.ie.
Adverse reactions /events should be reported to the Health Products Regulatory Authority (HPRA) using the available methods via www.hpra.ie. Adverse reactions/events should also be reported to Amgen Limited on +44 (0) 1223 436441 or Freephone 1800 535 160.
Adverse reactions /events should be reported to the Health Products Regulatory Authority (HPRA) using the available methods via www.hpra.ie. Adverse reactions/events should also be reported to Amgen Limited on +44 (0) 1223 436441 or Freephone 1800 535 160.
Adverse reactions /events should be reported to the Health Products Regulatory Authority (HPRA) using the available methods via www.hpra.ie. Adverse reactions/events should also be reported to Amgen Limited on +44 (0) 1223 436441 or Freephone 1800 535 160.
to follow the advice of your team and ask to speak to them not feeling well.
References:
Further information is available on request or in the Summary of Product Characteristics (SmPC) at www.medicines.ie.
References:
the injection in hospital or can give it to yourself or your can do this for you. Usually, the given every 2 weeks, but your change this to best suit what follow the advice of your and ask to speak to them feeling well. detailed instructions on how to
1. BVBM Amgevita Product Information Sheet. https://www.hse.ie/eng/about/who/cspd/ncps/ medicines-management/best-value-medicines/best-value-biological-medicines/bvb-medicineamgevita-product-information-sheet.pdf. Accessed January 2022.
Further information is available on request or in the Summary of Product Characteristics (SmPC) at www.medicines.ie.
EU/1/16/1164/001 – 1 pack: AMGEVITA 20 mg solution for injection in pre-filled syringe
EU/1/16/1164/003 – 2 pack: AMGEVITA 40 mg solution for injection in pre-filled syringe
Further information is available on request or in the Summary of Product Characteristics (SmPC) at www.medicines.ie.
References:
to follow the advice of your team and ask to speak to them not feeling well.
EU/1/16/1164/007 – 2 pack: AMGEVITA® 40 mg solution for injection in pre-filled pen
• Crohn’s disease
• Ankylosing spondylitis (AS)
• Axial spondyloarthritis without radiographic evidence of AS
• Axial spondyloarthritis without radiographic evidence of AS
• Ulcerative colitis
For full and detailed instructions on how to administer your AMGEVITA®, please read the instructions provided in the product carton.
• Psoriatic arthritis
• Psoriatic arthritis
• Psoriasis
• Axial spondyloarthritis without radiographic evidence of AS
• Crohn’s disease
• Crohn’s disease
• Psoriatic arthritis
• Hidradenitis suppurativa
• Ulcerative colitis
• Ulcerative colitis
• Uveitis
Adult
• Psoriasis
• Crohn’s disease
• Psoriasis
• Ulcerative colitis
• Rheumatoid arthritis
• Hidradenitis suppurativa
• Crohn’s disease (from 6 years of age)
• Enthesitis-related arthritis (from 6 years of age)
• Polyarticular juvenile idiopathic arthritis (JIA) (from 2 years of age)
• Enthesitis-related arthritis (from 6 years of age)
For full and detailed instructions on how to administer your AMGEVITA®, please read the instructions provided in the product carton.
• Hidradenitis suppurativa
• Psoriasis
• Ulcerative Colitis (from 6 years of age)
For full and detailed instructions on how to administer your AMGEVITA®, please read the instructions provided in the product carton.
1. BVBM Amgevita Product Information Sheet. https://www.hse.ie/eng/about/who/cspd/ncps/ medicines-management/best-value-medicines/best-value-biological-medicines/bvb-medicineamgevita-product-information-sheet.pdf. Accessed January 2022.
2. Medicines Management Programme Best-Value Biological Medicines: Adalimumab 20 mg solution for injection. https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-valuemedicines/best-value-biological-medicines/mmp-report-bvb-medicine-adalimumab-20mgmarch-2021.pdf. January 2022.
• Uveitis
• Ankylosing spondylitis (AS)
• Enthesitis-related arthritis (from 6 years of age)
• Crohn’s disease (from 6 years of age)
• Crohn’s disease (from 6 years of age)
For full and detailed instructions on how to administer your AMGEVITA®, please read the instructions provided in the product carton.
• Uveitis
• Hidradenitis suppurativa
You need to follow the advice of your healthcare team and ask to speak to them if you are not feeling well.
Marketing Authorisation Holder: Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands.
1. BVBM Amgevita Product Information Sheet. https://www.hse.ie/eng/about/who/cspd/ncps/ medicines-management/best-value-medicines/best-value-biological-medicines/bvb-medicineamgevita-product-information-sheet.pdf. Accessed January 2022.
1. BVBM Amgevita Product Information Sheet. https://www.hse.ie/eng/about/who/cspd/ncps/ medicines-management/best-value-medicines/best-value-biological-medicines/bvb-medicineamgevita-product-information-sheet.pdf. Accessed January 2022.
2. Medicines Management Programme Best-Value Biological Medicines: Adalimumab 20 mg solution for injection. https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-valuemedicines/best-value-biological-medicines/mmp-report-bvb-medicine-adalimumab-20mgmarch-2021.pdf. January 2022.
• Axial spondyloarthritis without radiographic evidence of AS
• Uveitis
• Psoriatic arthritis
• Plaque psoriasis (from 4 years of age)
Paediatric
• Ulcerative Colitis (from 6 years of age)
• Crohn’s disease (from 6 years of age)
• Ulcerative Colitis (from 6 years of age)
detailed instructions on how to your AMGEVITA®, please read the provided in the product carton.
2. Medicines Management Programme Best-Value Biological Medicines: Adalimumab 20 mg solution for injection. https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-valuemedicines/best-value-biological-medicines/mmp-report-bvb-medicine-adalimumab-20mgmarch-2021.pdf. January 2022.
Adverse reactions /events should be reported to the Health Products Regulatory Authority (HPRA) using the available methods via www.hpra.ie. Adverse reactions/events should also be reported to Amgen Limited on +44 (0) 1223 436441 or Freephone 1800 535 160.
• Crohn’s disease
2. Medicines Management Programme Best-Value Biological Medicines: Adalimumab 20 mg solution for injection. https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-valuemedicines/best-value-biological-medicines/mmp-report-bvb-medicine-adalimumab-20mgmarch-2021.pdf. January 2022.
detailed instructions on how to
detailed instructions on how to your AMGEVITA®, please read the
Further information is available on request or in the Summary of Product Characteristics (SmPC) at www.medicines.ie.
follow the advice of your
• Ulcerative colitis •
• Plaque psoriasis (from 4 years of age)
• Ulcerative Colitis (from 6 years of age)
• Adolescent hidradenitis suppurativa (acne inversa) (from 12 years of age)
• Polyarticular juvenile idiopathic arthritis (JIA) (from 2 years of age)
• Plaque psoriasis (from 4 years of age)
• Plaque psoriasis (from 4 years of age)
• Adolescent hidradenitis suppurativa (acne inversa) (from 12 years of age)
• Uveitis (from 2 years of age)
• Enthesitis-related arthritis (from 6 years of age)
For full and detailed instructions on how to administer your AMGEVITA®, please read the instructions provided in the product carton.
• Uveitis (from 2 years of age)
• Adolescent hidradenitis suppurativa (acne inversa) (from 12 years of age)
• Adolescent hidradenitis suppurativa (acne inversa) (from 12 years of age)
• Uveitis (from 2 years of age)
• Crohn’s disease (from 6 years of age)
• Uveitis (from 2 years of age)
• Ulcerative Colitis (from 6 years of age)
• Plaque psoriasis (from 4 years of age)
Influenza is a global health concern, with around one billion cases globally each year and up to 650,000 deaths. Vaccination remains the most effective method of preventing infection
Introduction
Influenza is a highly contagious viral infection that affects both the upper and lower respiratory tracts. Influenza is caused by a wide spectrum of influenza viruses. Influenza viruses are transmitted through respiratory droplets that are expelled from the respiratory system. These viruses can also live on surfaces and be transmitted in this way. Influenza can be transmitted before symptoms appear and until up to seven days after infection. There are four classes of influenza viruses: A, B, C, and D. Type A and B are the most common causes of seasonal influenza. Influenza can lead to mild-to-severe illness and can sometimes result in hospitalisation or death. It is a global health concern, with seasonal outbreaks occurring primarily in the winter months in temperate regions. The World Health Organisation (WHO) estimates that there are approximately one billion cases of influenza globally each year, with up to five million cases of severe illness, and up to 650,000 deaths.
All age groups can be affected by influenza, but
certain groups are more at risk than others. Healthcare workers are at a higher risk of influenza virus infection due to increased exposure and are at risk of spreading the virus to other individuals. Those at a greater risk of disease include:
Older individuals.
Children under five years of age.
Pregnant women.
Individuals with chronic medical conditions, including cardiovascular, renal, pulmonary, hepatic, or metabolic disease.
Immunosuppressed individuals, either due to disease or treatment.
Influenza is an acute disease that targets the respiratory system and causes inflammation. Symptoms usually begin approximately two days after infection. The disease is usually self-limiting in most healthy individuals and acute symptoms can persist for seven-to-10 days. Symptoms of influenza include:
Sudden onset of fever.
Cough.
Headache.
Muscle and joint pain.
Malaise.
Fatigue.
Sore throat.
Gastrointestinal symptoms such as nausea, vomiting, and diarrhoea, particularly in children. Most people will recover from fever and other symptoms within 10 days without medical attention, but the cough can often persist for longer than two weeks. Severe complications can arise within 48 hours from onset of symptoms and can include primary viral pneumonia, secondary bacterial pneumonia, sepsis, and haemorrhagic bronchitis. Furthermore, influenza can worsen symptoms of chronic diseases and lead to poor clinical outcomes. Hospitalisation and death can occur in high-risk individuals.
Prevention is vital in reducing the spread of influenza. Measures including regular hand-washing with soap, avoidance of touching the face, and covering coughs and sneezes with a tissue (and discarding the tissue immediately after use) are very effective in preventing the spread of influenza viruses. Cleaning surfaces that people regularly touch and improving ventilation can also be effective in this regard. Avoiding close contact with individuals when symptomatic is also an important practical measure which helps to reduce the transmission of influenza.
In high-risk patients, initiation of treatment should not be delayed until test results confirm diagnosis
Vaccination is the most effective method of preventing infection. Furthermore, vaccination reduces morbidity associated with influenza. Vaccinations contain weakened or inactive parts of a pathogen, which triggers an immune response in the body that will produce antibodies and offer protection if exposed to the pathogen at a later stage. The influenza vaccination should be administered annually, given that antibodies decline over time and influenza strains can differ year-to-year. Timing of immunisation is important, with the recommendation for administration during September or October. Vaccination can continue for as long as influenza viruses are circulating. Vaccination generally reduces the risk of getting flu by 40 per cent to 60 per cent and can also reduce the intensity and
duration of symptoms. There are usually two vaccines available in Ireland: A quadrivalent influenza vaccine (QIV) and a live attenuated influenza vaccine (LAIV). The QIV is generally used for individuals over 18 years old and is administered via intramuscular injection. The LAIV is used for those aged two to 17 years old and is administered nasally. Mild adverse effects are possible after vaccination and can include fever, fatigue, soreness or swelling at injection site, body aches, and headaches. Nasal congestion is common after nasal administration. The adverse effects are generally self-limiting and usually resolve within 48 hours. Administration of paracetamol and rest are advised if adverse effects are experienced.
The diagnosis of influenza is generally based on clinical symptoms and physical examination. Most healthy individuals recover without medical intervention and would not require laboratory testing. In high-risk patients, initiation of treatment should not be delayed until test results confirm diagnosis. Therefore, especially during influenza season, diagnosis can often be reached clinically. The gold standard for diagnosis is a polymerase chain reaction (PCR) test or taking a viral culture of throat secretions. However, these tests may take days to confirm diagnosis. These tests may be useful in cases to inform clinical action or public health interventions. Further investigations, including chest x-rays, may be obtained to exclude bacterial pneumonia.
Influenza is self-limiting in most healthy individuals and therefore won’t require antiviral treatment, unless deemed necessary by a clinician. In these individuals, relief of severity and duration of symptoms
may be the treatment objective.
Antihistamines that are available over-the-counter (OTC), such as brompheniramine and chlorpheniramine, may reduce symptoms associated with nasal discharge and sneezing, but these are accompanied by drowsiness.
Decongestants can be effective in reducing symptoms of rhinorrhoea, nasal congestion, and sneezing. Pseudoephedrine and phenylephrine are two decongestants that are available OTC for oral administration, while xylometazoline is available as a nasal spray. Adverse effects can include hypertension, agitation, tachycardia, and dysrhythmia. A wide range of cough medications are available to treat cough associated with influenza. Dextromethorphan is a non-opioid antitussive and can be effective in suppressing cough. Expectorants and mucolytics, such as carbocisteine and guaifenesin, can treat a productive cough by increasing the volume of sputum in the airway and decreasing the viscosity, promoting effective clearance of mucus.
Codeine is an opioid antitussive and used to be the gold standard treatment for cough. However, it is no longer recommended for first-line treatment due to lack of evidence of efficacy and many adverse effects associated with it, including dependence, drowsiness, and constipation. Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) may provide analgesia for associated headaches and body aches. Additionally, self-care measures such as rest, hydration, nutrition, and avoiding smoking can also help to alleviate symptoms.
Antiviral medication may be required to treat or prevent influenza infection, particularly in high-risk patients or during outbreaks in healthcare settings. Oseltamivir is an antiviral of the neuraminidase inhibitor class that is administered orally and has
activity against both influenza A and B. High-risk patients or those who are deemed to be at risk of complications should be commenced on oseltamivir as soon as possible, even without laboratory confirmation of diagnosis. Oseltamivir is also recommended for treating influenza in pregnancy due to potential adverse clinical outcomes for this patient group. Initiating antiviral treatment within 48 hours of symptom onset can reduce risk of complications, including pneumonia and respiratory failure. It can also reduce risk of hospitalisation, morbidity, and mortality. The recommended treatment dose of oseltamivir is 75mg twice daily for
Dextromethorphan is a non-opioid antitussive and can be effective in suppressing cough
adults and adolescents aged 13 years and over, with a body weight of greater than 40kg. In infants and children aged from one-to-12 years, a weight-adjusted dosing regimen is recommended. Adverse effects of oseltamivir include skin reactions and sporadic transient neuropsychiatric events. Duration of treatment is usually five days, with 10 days recommended for immunocompromised individuals. If oseltamivir resistance is suspected, zanamivir can be initiated within 48 hours of symptom onset. Zanamivir is also a neuraminidase inhibitor class that is effective against both influenza A and B. The recommended dose is 10mg (two inhalations) every 12 hours. The product is authorised for use in the EU but as it is not marketed in Ireland, it is only available as an unlicensed product. Specialised advice should be sought if considering initiating zanamivir.
Pharmacists play a vital role in the management, treatment, and prevention of influenza. Due to their expertise, accessibility, and patient interactions, they are ideally placed to combat influenza. Pharmacists can counsel patients on signs of complications, including difficulty breathing, chest pain, and persistent high fever — and when to seek further medical attention. Pharmacists can also advise on appropriate OTC treatment to relieve symptoms, as well as thoroughly counselling on antiviral therapy. Pharmacists can also collaborate with other healthcare professionals as part of antimicrobial stewardship programmes. These are a set of measures that have the objective of improving the appropriate use of antimicrobials. It does this by ensuring the correct antimicrobial treatment is selected for the appropriate infection, as well as the correct duration of therapy, dosage, and route of administration. Pharmacists can play their role in this as part of a multidisciplinary team and effectively communicate clinical decisions to patients.
Pharmacists also play an integral role in preventive measures around influenza. Pharmacists can counsel patients on hand hygiene techniques and other measures to reduce transmission of influenza viruses. As part of preventive measures, pharmacists have been providing a seasonal influenza vaccination service in community pharmacies since 2011, which has seen an increase in the uptake of the vaccination. Pharmacists are trusted healthcare professionals and play an important role in patient education about influenza vaccination. Pharmacists can counsel patients on the benefits of vaccination, risks of not getting vaccinated, and ease patient concerns regarding potential adverse effects. ●
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Selenium contributes to: normal functioning of the immune system and thyroid, normal spermatogenesis, maintenance of normal hair and nails, and the protection of cells from oxidative stress
An overview of the various conditions that can affect our hair and scalp, as well as the management strategies and treatment options available
Introduction
Hair and scalp care is an important aspect of health and personal hygiene that is often overlooked. It is an important part of overall health, often having an impact on self-esteem and quality-of-life. The scalp has the function of acting as a physical barrier to protect the cranium from physical trauma and pathogens that can cause infection. The scalp is also a highly vascularised area with hair follicles and sebaceous glands. Hair has an important role in thermoregulation. Additionally, hair protects from ultraviolet radiation. Hair also plays a role in sexual signalling and is important in an individual’s self-identity. However, there are several conditions that can affect the hair and scalp. This article will provide an overview of good hair and scalp care practices; various conditions that can affect hair and scalp; management strategies; and treatment options available.
Hair and scalp health is influenced by several factors, including genetics, hormonal changes, environmental factors, diet, personal care practices, and overall health. Many conditions have a genetic component, while hormonal changes due to pregnancy, menopause, or thyroid issues can have an impact on hair and scalp health. Physical and emotional stress can negatively impact hair and scalp health, while deficiencies in essential vitamins and minerals can also play a role. Keratin is a protein that is the primary component of hair that grows from
hair follicles in the scalp.
The scalp is a sensitive area and environmental factors — including UV radiation, pollution, and harsh hair treatments — can damage the structure. Additionally, underlying health conditions can have an impact on the scalp, with psoriasis and seborrheic dermatitis common examples.
Alopecia is the absence or loss of hair in areas where hair is expected to be present. It can affect both males and females and all age groups. Patients may experience significant psychological distress and have a diminished quality of life. Alopecia may be temporary or permanent, and can be classified as scarring or non-scarring.
Androgenetic alopecia is a scarring alopecia, commonly known as male or female pattern baldness. It is due to an excessive response to androgens and is characterised by progressive loss of terminal hair at any stage after puberty.
Alopecia areata is a chronic autoimmune disorder that disrupts the normal hair cycle and leads to hair loss without permanent follicle damage.
Telogen effluvium is a temporary scarring alopecia characterised by excessive shedding of resting hair after metabolic stress, hormonal changes, or medication.
Scarring alopecia occurs when the hair follicle is irreversibly destroyed and replaced by fibrous tissue. Scarring alopecia is rarer, with limited treatment options available.
Patient history and physical examination are generally used in the diagnosis of alopecia. Further investigations may be used to confirm diagnosis, and these include a complete blood count, complete metabolic panel, iron levels, thyroid-stimulating hormone levels, and vitamin D levels.
The main objective of androgenetic alopecia treatment is to stop hair loss, preventing or slowing further hair loss, and promoting hair growth. Topical
minoxidil and oral finasteride are firstline treatments in males, while topical minoxidil is the first-line treatment for females. Finasteride is a 5 alpha-reductase inhibitor and works by decreasing the production of dihydrotestosterone. It is generally administered orally at a dose of 1mg, with sexual dysfunction the most common adverse effect. Minoxidil acts a potassium channel blocker, which facilitates dilation of blood vessels. This increases vascularisation and enables greater delivery of blood, oxygen, and nutrients to hair follicles, and stimulates hair growth. Treating underlying conditions such as nutritional deficiency and hyperandrogenism may also be
Seborrheic dermatitis is an inflammatory skin disease that presents in areas of the body that are rich in sebaceous glands
useful. Other treatment options include microneedling, low-level laser therapy, platelet-rich plasma, and autologous hair transplantation.
Treatment for alopecia areata aims to immunomodulate the activity of the autoimmune disease. Topical corticosteroids are first-line therapy for mild alopecia areata and are used as adjunctive therapy in more severe disease, while intralesional corticosteroid injections can also be used. Oral corticosteroids may be used for moderate-to-severe disease, while immunomodulators such as methotrexate may be a treatment option. Telogen effluvium is reversible — removing the trigger and treating any underlying condition is recommended — while counselling is also an important aspect of treatment.
Seborrheic dermatitis (SD) is an inflammatory skin disease that presents
in areas of the body that are rich in sebaceous glands. SD can occur on the scalp, face, and body folds. SD causes flaking, scaling, inflammation, and pruritus on different areas of the body, while dandruff is a milder form of SD that is restricted to the scalp and causes itchy, flaking skin without visible inflammation. Infantile SD usually appears in the first three months of life and presents as cradle cap — greasy scales on the crown and front of the scalp. This is usually self-limiting and resolves within the first 12 months. Adult SD or dandruff is characterised by a relapsing and remitting presentation. The aetiology of SD is believed to be multifactorial, with the Malassezia species of fungus, composition of lipids on the skin, and individual susceptibility thought to play a role. Risk factors for the development of SD include age, male sex, immunodeficiency, increased sebaceous activity, exposure to certain medications, and comorbidities.
Diagnosis is usually based on a physical evaluation, while treatment can vary depending on the age of the patient and severity of the symptoms. Using a soap substitute and appropriate moisturising are important in the management of this condition. The objectives of treatment are improving symptoms and maintaining remission. Topical antifungal therapy is often the first-line treatment, with shampoo formulations often containing ketoconazole and ciclopirox. Corticosteroids are also used topically to reduce inflammation and relieve other symptoms, with betamethasone and clobetasol two common examples. Newer therapies include immunomodulators such as topical calcineurin inhibitors, for example, tacrolimus. Coal tar can be used as a keratolytic agent to remove scaling, while alternative treatments such as tea tree oil and coconut oil may have some benefit. Systemic treatment is generally reserved for very severe symptoms or if the patient has not responded to topical therapy. Pediculosis, also known as louse infestation, is a common condition that affects millions of people worldwide. Lice are obligate parasites that are transmitted
through direct skin-to-skin contact, or object-to-skin contact. Two main variations affect humans — pediculus humanus capitis (head lice) and pthirus pubis (pubic or crab lice).
Head lice are typically 1-3mm long, while pubic lice are much smaller. Pruritis, generally from an immune-mediated hypersensitivity reaction, is the most frequent presentation. This may take twoto-six weeks to develop and can lead to secondary bacterial infection. Diagnosis is usually made after physical examination in most cases. Lice can be removed physically, through shaving affected areas or by physical removal with a comb, with cure rates varying widely. Treatment often kills the lice, but doesn’t reliably kill the eggs, therefore repeat treatment is often necessary for complete eradication. Permethrin and malathion are pediculicides and work by causing neurotoxicity and resulting in paralysis of the louse. Other methods, such as dimethicone, work by suffocation of the louse from topical application.
Bacterial, fungal, and viral infections can affect the scalp and cause symptoms such as inflammation, redness, itching, and hair loss. Tinea capitis, often known as scalp ringworm, is a fungal infection of the scalp hairs primarily caused by dermatophyte species Microsporum and Trichophyton. Tinea capitis often presents in children aged between three and 14 years, but can affect any age group.
Eyelashes and eyebrows may also be involved. Red papules, that usually spread over time, are one of the first symptoms. The whole scalp may be involved, and symptoms include redness, inflammation, itching, scale formation, and alopecia. A fungal culture swab, biopsy, or scraping from the scalp can be used to confirm diagnosis. Systemic antifungal medications are first-line treatment for tinea capitis. Griseofulvin, itraconazole, and fluconazole are all oral treatment options. Terbinafine, an allylamine agent, is also an oral treatment option. Oral corticosteroids may be used for a short period if inflammation is present. Antifungal and
corticosteroids may be used topically as an add-on treatment.
Common dermatology conditions, including psoriasis and dermatitis, can affect the scalp. Psoriasis is an immunemediated inflammatory disease, involving skin and joints. Plaque psoriasis is the most common clinical presentation of psoriasis. Plaque psoriasis usually presents with large plaques over the scalp, trunk, and extensor body surface. These plaques may be covered with silvery-white scales and may cause some pain. Plaque psoriasis can cause itching, particularly when the scalp is involved. Treatment should be individualised for the patient depending on the severity, patient age, and quality-of-life issues. Treatment can be categorised into topical treatments, systemic therapy, phototherapy, and biologic treatment.
Paraphenylenediamine is present in hair dye and is a common cause of allergic contact dermatitis on the scalp
Topical treatment includes the use of emollients, moisturisers, corticosteroids, vitamin D analogues, calcineurin inhibitors, and keratolytic agents. A combination of topical agents may be more effective than monotherapy. Systemic medication to treat psoriasis are generally immunomodulators and include acitretin, methotrexate, cyclosporine, tacrolimus, and hydroxyurea. Biologic agents, including etanercept, adalimumab, infliximab, secukinumab, and ustekinumab, can be effective in treating moderate-to-severe disease.
Contact dermatitis is an inflammatory skin disease that can also affect the scalp. It is caused by chemicals that exert toxic effects without inducing a T-cell response (irritant contact dermatitis) or by inducing innate and adaptive immune responses (allergen contact dermatitis).
Paraphenylenediamine is present in hair dye and is a common cause of allergic contact dermatitis on the scalp. Contact dermatitis usually presents with symptoms of burning, itching, stinging, pruritus, and pain.
Contact dermatitis can present with three morphological patterns. The acute phase includes symptoms of erythema, oozing, crusting, vesicles, or pustules; the subacute phase with crusting, scales and hyperpigmentation; and the chronic phase with lichenification. The mainstay of management of contact dermatitis is avoidance of the causative agent. Topical corticosteroids may be used to reduce inflammation associated with dermatitis. Oral or topical antihistamines can be helpful in controlling pruritus. Systemic corticosteroids may be used in severe cases.
Pharmacists can play an integral role in maintaining good hair and scalp care, including the management of related conditions. Pharmacists are ideally positioned in the community to provide advice and treatment for common hair and scalp conditions. Pharmacists can provide over-the-counter products and counsel patients on their use if appropriate. They can also educate patients on appropriate use of prescription medications, while emphasising the importance of medication adherence in improving clinical outcomes.
Pharmacists can also identify cases that require referral to other healthcare professionals for evaluation, with early intervention important in improving clinical outcomes. Patients may be referred in the case of severe or persistent symptoms, signs of infection, and sudden or extensive hair loss.
Pharmacists can also educate patients on proper hair and scalp care practices, including good hygiene, proper nutrition, adequate hydration, and product selection. Furthermore, pharmacists can encourage patients to practise stress management techniques, as stress can contribute to hair loss and scalp conditions. ●
Introduction
Fatigue is a disabling symptom in which physical and cognitive function is limited, and there is a complex and multifactorial pathophysiology.1 It is a common, nonspecific symptom with a broad range of causes which include acute and chronic medical conditions, psychological conditions, medication toxicity, and substance abuse.2 Different definitions exist for 'energy' or 'fatigue'. Fatigue can be a perceived lack of energy or vitality,3 described as a difficulty or inability to initiate activity (subjective sense of weakness); reduced ability to maintain activity; difficulty with concentration,
With up to 33 per cent of adults experiencing chronic fatigue of six months or longer, it is more important than ever to explore treatment of this complex and multifactorial symptom memory, and emotional stability; or sleepiness/uncontrollable need to sleep. Generally, energy is associated with feelings of wellbeing, stamina, and vitality and it allows people to perform their daily physical and intellectual activities, and enjoy social relationships.
Fatigue is a complex and wide-reaching state with no clear aetiology. Up to 33 per cent of adults can experience chronic fatigue lasting for six months or longer.1 Fatigue has a negative effect on physical and mental health and is associated with increased levels of anxiety and depression. Long-term or severe fatigue can also lead to ageing, cancer, multiple sclerosis, and Parkinson’s disease.
Fatigue is also common in healthy people. Normal levels of fatigue –usually occurring after, for example, strong physical effort – are a protective signal from the body to tell us that rest is needed. Pathological fatigue does not improve with rest. It is usually more intense and longer lasting. Table 1 describes some of the possible mechanisms behind pathological fatigue.
The most common causes of tiredness and fatigue include:4
Not getting enough sleep or finding it difficult to fall asleep.
Unhealthy lifestyle (poor diet and
Endocrine system HPA axis dysregulation
CNS Reduction/polymorphism of neurotransmitters
Increase in serotonin/dopamine ratio
PNS Altered autonomic nervous system
Metabolic activity
Stimulation of vagus nerve from inflammation
Metabolite accumulation
Reduced free energy from ATP breakdown
Limited oxygen/substrate availability
Mitochondrial dysfunction
Glycogen storage Reduction of glycogen storage leading to a drop in blood glucose levels
Immune system Increase in pro-inflammatory cytokines (IL-1, IL-6, TNF alpha)
Proliferation of immune cells
Anaemia Reduced tissue oxygenation
Oxidative stress Excess ROS formation
Others Side-effects from treatments, viral infection, circadian rhythm disorder
Hypothalamic-pituitary-adrenal (HPA); central nervous system (CNS); peripheral nervous system (PNS); adenosine triphosphate (ATP); interleukin (IL); tumour necrosis factor (TNF).
Sleep apnoea
Iron-deficiency anaemia
Tired during the day due to night-time waking; gasping, choking, or snorting noise at night; loud snoring
Low energy, palpitations, shortness of breath, pale skin
Diabetes Tired, thirsty, increased urination, weight loss
Hyperthyroidism
Myalgic encephalomyelitis (ME) or chronic fatigue syndrome (CFS)
lack of exercise).
Tired all the time, feeling nervous, anxious, irritable, muscle weakness, tachycardia
Extreme fatigue for ≥ three months that impacts quality of life, problems with cognitive function and concentration, flu-like symptoms
Stress or depression, life challenges like bereavement or looking after a new baby.
Hormonal changes (puberty, pregnancy, menopause).
Illnesses.
Medical treatment, ie, chemotherapy. On average, adults need between six and nine hours of sleep. Increasing sleep duration and quality, if possible, may be sufficient to improve fatigue. A healthy diet with no meals before bed, regular exercise, and cutting out alcohol/smoking can help with this. Avoiding screens and exercise late in the evening, as well as
winding down before bed (ie, read, listen to music or a podcast) can also help. Certain medical conditions can lead to fatigue, including diabetes, hyperthyroidism, anaemia, high BMI, and liver disease.1 Any prolonged, unexplained fatigue may be a symptom of an underlying condition (see Table 2) and should be assessed by a GP. Blood tests can be used to ascertain the cause of many cases of fatigue.
Muscle fatigue from intense and/or sustained physical activity has both
Chronic fatigue includes chronic fatigue syndrome and idiopathic chronic fatigue
central and peripheral components.1
Central fatigue, mediated by the CNS, is characterised by the inability to transmit motor impulses, with a decrease in the number/discharge rates of the motor units (ie, the combination of an individual motor neuron and all of the muscle fibres that it innervates). This phenomenon may also be linked to the depletion or accumulation of certain neurotransmitters – ie, serotonin and dopamine – which results in reduced neuronal excitability and depleted brain glycogen levels.
Peripheral fatigue results from the lack of response of, or loss of maximal force, in the neuromuscular system after central stimulation. This is associated with metabolite and free radical accumulation, limited oxygen and substrate availability, exhaustion of available glycogen, and increased levels of lactic acid.
Mental fatigue is a psychobiological state that manifests due to prolonged periods of demanding cognitive activity. Complicated information bombardment, noise, poor working conditions, disease, family issues, interpersonal tension, career frustration, and overwork are just some contributors to mental fatigue in today’s fast-paced and competitive environment.
Chronic fatigue includes chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF). CFS is diagnosed with six months or more of chronic fatigue, not alleviated by rest, accompanied by four of eight additional symptoms including headaches, sore throat, and myalgia. Physiological biomarkers of the disease have not been identified conclusively and the pathophysiology is unclear, although it is thought that viral infection, as well as endocrine, psychosocial, and
immunological factors, are involved.
Acute fatigue, which is defined as lasting for a month or less, is usually attributed to a recent life stressor or acute medical condition. 2
Subacute/chronic fatigue lasts between one and six months and is often linked to an underlying medical or psychological issue, medication toxicity, or substance abuse. It is estimated that the origin of chronic fatigue can be identified in about two-thirds of people. In the remaining third with no identifiable cause, fatigue is classified as ICF, or attributed to CFS/ME if appropriate given the diagnostic criteria.
When patients seek treatment of fatigue with unclear aetiology, the following should be looked at:2
Complete blood count.
Glucose, electrolytes, calcium, renal, and hepatic function.
Thyroid stimulating hormone.
Creatinine kinase (if muscle pain or weakness is an issue).
A supportive relationship between the patient and treating clinician should be established, with acceptance that chronic fatigue is a real and debilitating symptom. Therapeutic goals, for example returning to work and managing daily activities, should be identified. Depending on the cause, possible treatments include cognitive behaviour therapy (CBT); advice on how to get better sleep; or advice on how to relax/change your lifestyle.
It is important to address any underlying medical conditions and fatigue should be monitored for improvement. Patients who still experience residual or idiopathic fatigue may benefit from a trial of antidepressants (SSRI/SNRI), CBT, or exercise therapy. CBT for chronic fatigue includes explaining the model for chronic fatigue, challenging beliefs and awareness of fatigue and reorienting these, promoting physical/personal goals, and attaining control of symptoms.
Exercise therapy has shown comparable efficacy to CBT in unexplained fatigue in a three-month trial, although it does not
specifically address cognition.
All of the B vitamins except folate play a role in energy production in the body; for example, vitamins B6, B9, and B12 are required for oxygen transport. 3 Vitamin C also plays an important role in mitochondrial energy production, while iron is required in oxygen transport for cellular energy production. Magnesium has a large role in production and use of adenosine triphosphate (ATP). The role of vitamins and minerals in cellular energy production strongly impacts functional and physiological outcomes in humans, including fatigue. Supplementation with vitamins and minerals can be beneficial in treating mental and physical fatigue, as well as in supporting cognitive and psychological functions.
There is some evidence that ginseng supplementation may help with certain types of fatigue, ie, a beneficial impact was observed on cancer-related fatigue from taking American ginseng, 2,000mg daily, over an eight-week period. 5 However, in a separate randomised controlled trial looking at the effect of Siberian ginseng on chronic fatigue (no identifiable cause), no definitive reduction in fatigue levels was established. 6 In a systematic review looking at
1. Luo C, Xu X, Wei X, et al. (2019). Natural medicines for the treatment of fatigue: Bioactive components, pharmacology, and mechanisms. Pharmacological Research, 148, 104409.
2. Fosnocht K and Ende J (2024). Approach to the adult patient with fatigue. UpToDate. Retrieved 26 June 2024 from: www.uptodate.com/contents/approach-to-the-adultpatient-with-fatigue.
3. Tardy AL, Pouteau E, Marquez D, et al (2020). Vitamins and minerals for energy, fatigue and cognition: A narrative review of the biochemical and clinical evidence. Nutrients , 12(1), 228.
4. National Health Service (2023). Tiredness
pharmacological treatment specifically of cancer-related fatigue, methylphenidate, modafinil, and paroxetine were identified as superior to placebo.7
There is a limited range of established pharmacological treatments available for the treatment of fatigue. Much of the assessment of available pharmacological treatments for fatigue have been tested on animals in terms of physical fatigability, and measured by, for example, improving exercise time.1 The translational success of this narrow definition of reduced fatigue to a predictable and meaningful effect in humans is varied. Patient-reported outcomes are usually used to assess the efficacy of an anti-fatigue treatment in humans; however, the inherent problem with lack of biomarkers for fatigue makes objective evaluation difficult. As health professionals, pharmacists are often questioned about fatigue, and possible psychological or cognitive difficulties. Once any pathological cause is ruled out, the person’s vitamin and mineral intake may need to be assessed, and advice given – firstly on a balanced diet and food choices, and secondly on use of vitamin and mineral supplementation. 3 ●
and Fatigue. Available from: www.nhs.uk/ conditions/tiredness-and-fatigue/.
5. Barton DL, Liu H, Dakhil SR, et al (2013). Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: A randomised, double-blind trial, N07C2. Journal of the National Cancer Institute , 105(16), 1230-1238.
6. Hartz AJ, Bentler S, Noyes R, et al (2004). Randomised, controlled trial of Siberian ginseng for chronic fatigue. Psychological Medicine , 34(1), 51-61.
7. Chow R, Bruera E, Sanatani M, et al (2023). Cancer-related fatigue – pharmacological interventions: Systematic review and network meta-analysis. BMJ Supportive & Palliative Care , 13(3), 274-280.
Dr Alan Moran test drives the new E220D, a quiet but powerful beast
There is a lot of publicity given to the Volkswagen Golf, which is celebrating 50 years in production. Fair dues to them. I have memories of the first Golfs appearing on the roads when I was a teenager. What Mercedes has kept as a closely guarded secret is that their saloon has been in production since 1953, although it was not always known as an E-Class. The car has been evolving ever since — the link is obvious if you were to see sequential photographs of all the models.
This week’s test car is the latest incarnation. It is a direct replacement for our own family vehicle, an E200, known internally as W212. And, I have to say, the difference is massive. Although the S-Class has been the leader with technological innovations (first with a driver’s airbag, first with a reliable antilock braking system, a padded steering wheel, the list goes on) the E-Class always follows closely behind.
Now the upgraded E-Class, the W124, has an interior that closely resembles the current S-Class. Although its dimensions are similar to the outgoing model, it manages to look bigger and, judging by the careful redesign of the interior, it is catching up to the S-Class for space.
Features
Mercedes prices have gone up, but they are promising an increase in quality. They are also reducing sales targets. Anyway, my previous car, the E200, is no longer available. Although the old car has 134bhp, enough for most needs, you’d know it was struggling if you had four adults and were trying to overtake going uphill on a motorway. Now the E220D has 197bhp with 440Nm of torque, with the now-standard mild hybrid adding 23bhp and 205Nm of torque. And, with the
much-praised aluminium diesel engine, it is a lot quieter. An automatic gearbox is standard (manual E and C-Class were sales proof – don’t ever buy one) and is now an extremely smooth nine-speed. Upgrades from the previous model include, amongst others, folding back seats (very welcome), memory electric seats (ditto), folding door mirrors, LED headlights, and navigation via the multimedia interface. And it has a 360-degree camera.
The Mercedes badge has reappeared on the end of the bonnet. But with increasing safety, and with the slight bow shape of the bonnet for pedestrian safety, the mascot now appears like a setting sun.
I’ve had issues before with Mercedes’ navigation. Using their interactive commands, similar to Alexa and Siri, the car can be addressed by just saying 'Hey Mercedes'. I asked if it could navigate to Drogheda? No. It was sending me to the UK. I tried using the ‘what3words’ system. That didn’t work either. At times I felt I needed the diction of a BBC newsreader for it to understand me. And yet other times it will change the air con settings, close the electric windows, or adjust the radio volume without question. It may well be a learning curve thing. Although the multimedia screen is large, it is discreet. The screen is placed low and
tilted forwards, which is much better than the vertical positioning in other cars. It is also available as a full-width screen, called Superscreen (Hyperscreen is for the S-Class), which allows passengers to watch films and surf the Internet while someone else drives and wonders what they’re laughing at.
To me, the single biggest improvement was the engine. Not only does it produce more power and operate more quietly, but it is also very economical.
My wife is a harsh critic of any new car. She did not like the new E-Class, saying it was noisier than her car. I blamed the wheels and tyres. Normally, when we opt for tyres in our household, we will buy Michelin, based on driving a previous Punto, which was remarkably sensitive to tyre choice and road noise. In our locality, we have quite a number of road surfaces covered in a mix of tarmac and stone. And it is noisy. The E-Class was shod with the optional 19-inch wheels and Pirelli tyres, which are fine on smooth motorways. They are also great for roadholding. But not on the back roads around Drogheda. And, in my opinion, I don’t think 19inch wheels are really necessary on a comfortable executive saloon.
Car prices have risen, both new and used. I know people who have bought Mercedes with monotonous regularity over the years and previously received discounts. But they have been told over the last couple of years: 'No discount.'
So, is it worth 50 per cent more than it was nine years ago? Considering the level of equipment, the performance, and the economy, a 50 per cent rise in price is not surprising. The E220d can be yours from €81,000, or the petrol plug-in hybrid from €79,000. And if it is anything like the car we have, you might well be keeping it for quite a while. ●
Alexion, AstraZeneca Rare Disease, has announced a partnership with Hometree, an environmental charity, to accelerate the regeneration of Atlantic rainforests in Ireland. Launched at Hometree’s site in Avoca, the partnership includes a €90,000 investment from Alexion to support the reintroduction of rainforest ecosystems across eighteen acres of agricultural land in the Maam Valley, Connemara, Co Galway.
Once covering 80 per cent of Ireland, natural forests have experienced significant decline over the centuries from agriculture, fuel, and timber industries, leading to significant deforestation. Today less than 1 per cent of Ireland’s ancient woodland cover remains, with only a few fragments of that being Atlantic rainforest.
Within five years of starting the project, early signs of woodland regeneration are expected to be visible, alongside restored peatlands, heath, and species-rich grasslands. After 15 years, the landscape is predicted to increasingly resemble its original natural state, the most striking feature being the abundance and lushness of mosses, liverworts (collectively known as bryophytes) and ferns. As the rainforest returns, rocks and boulders will be covered in a luxuriant, vibrant mat of mosses and liverworts or Filmy Ferns (Hymenophyllum species), as will the trunks and branches of the trees. This will, in turn, encourage the animals once native in the area to return, such as the pine marten, wood mouse, and tree creeper.
According to Alexion, the partnership reflects its commitment to sustainability in Ireland, local communities, and to its workforce operating across Dublin and Athlone. Recognising the connection between a healthy planet and healthy people, and as part of an overall sustainability strategy, the company said it is committed to proactively managing its environmental impact, and investing in nature and biodiversity. The forest regeneration partnership with Hometree
Safety, Alexion.
complements AstraZeneca’s global AZ Forest commitment to plant and maintain 200 million trees across six continents by 2030. Working in partnership with planting experts, local communities and governments, AZ Forest projects are designed to build ecological and community resilience.
Mr Shane Doyle, Senior Vice President, Global Head of Operations and Sustainability, Alexion, AstraZeneca Rare Disease, said: “Whilst we don’t commonly associate Ireland with rainforests, they are a vital part of our heritage, and restoring these ecosystems is essential for the wellbeing of both present and future generations. Through this partnership with Hometree we are underscoring our commitment to sustainability in Ireland, and taking affirmative action to reinstate ecosystems that will improve biodiversity, human health, and restore our cultural heritage.”
Mr Matt Smith, Chief Executive, Hometree, said: “I am thrilled to announce
our partnership with Alexion, AstraZeneca to restore Atlantic rainforests in Ireland. Their investment fuels practical action, enabling Hometree to restore ecosystems that benefit us all. There is more investment needed and partnership between industry and not-for-profits is central to that, but today we have made a strong start to building a sustainable future, grounded in real impact.”
The partnership follows the passing of the EU Nature Restoration Law, which set a target for the EU to restore at least 20 per cent of its land and sea areas by 2030 and all ecosystems in need of restoration by 2050.
The initiative will also provide Alexion and AstraZeneca employees across Ireland with an opportunity to engage with Hometree through educational programmes and volunteerism, fostering a sense of stewardship and environmental responsibility among its 1,200 strong workforce across its Dublin and Athlone sites.
The Accelerating Clinical Trials in the EU (ACT EU) initiative has launched two advice pilots aimed at improving the quality of applications for clinical trials.
ACT EU is a collaboration between the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) in the Member States and the European Commission (EC), which seeks to transform how clinical trials are initiated, designed and run.
The first pilot offers developers of medicinal products scientific advice on clinical trials and on requirements for marketing authorisation applications (MAA). Assessors of clinical trials are not consistently involved in scientific advice procedures for MAAs, and vice versa. In this pilot programme, the scientific advice working party (SAWP), co-ordinated by the EMA, and the clinical trials coordination group (CTCG), managed by HMA, will be the bodies assessing incoming requests of a scientific nature. The SAWP is responsible for advice on
marketing authorisation applications and the Member States represented at CTCG oversee clinical trial applications (CTA). This pilot consolidates the views of these two groups to minimise avoidable divergences. It is the first time that both entities are providing joint scientific advice on clinical trials.
The second pilot is co-ordinated by the CTCG and provides technical and regulatory support on the dossier of a CTA prior to its submission through the Clinical Trials Information System. Before this pilot, applicants could only receive technical and regulatory support at national level from the Member State evaluating the application. The pre-CTA pilot will provide consolidated views of the Member States concerned on pre-submission topics. The scope of this pilot covers areas such as advice on regulatory aspects of low interventional clinical trial status and submission of trials with decentralised elements or complex designs.
Developers of medicinal products who
wish to receive advice on the requirements for a MAA or a CTA may apply to these pilots. The duration of both pilots will be evaluated over time based on data and feedback collected from applicants. This information will inform a possible change of scope and a final decision from the ACT EU steering group on how to optimise clinical trial support in the future.
By strengthening the co-ordination of the European medicines regulatory network, the advice pilots offer applicants additional support to enhance the quality of their applications for marketing and/or clinical trial authorisation.
ACT EU was launched in January 2022 and aims to further develop the EU as a focal point for clinical research, to promote the development of highquality, safe and effective medicines, and to better integrate clinical research in the European health system. ACT EU features priority action areas that are the basis for its multi-annual workplan covering the period 2023 to 2026.
Clonmel Healthcare launches Uzpruvo (Ustekinumab) –the first approved
Clonmel Healthcare are delighted to announce the introduction of Uzpruvo®, the new Ustekinumab biosimilar. Uzpruvo has been marketed from 22 July 2024, upon expiry of patent protection of the active ingredient of the reference biological medicine.
Uzpruvo 45mg and 90mg solution for injection in pre-filled syringe are indicated for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease. Uzpruvo is currently not approved for the treatment of ulcerative colitis indication (since the originator still has exclusivity for this indication).
Uzpruvo offers patients a wide variety of benefits:
European manufacturing and supply chain*
Equivalent efficacy, safety and immunogenicity to the reference product**
Patient-friendly PFS: Easy handling, thinner needle+, latex-free++1,3
Cost-effective option enabling improved access to ustekinumab treatment
Donagh O’Leary, General Manager, said: “Clonmel Healthcare continues to grow and strengthen its portfolio of biosimilar medicines, which now spans several therapeutic areas including rheumatology, gastroenterology dermatology and oncology. We remain steadfastly committed to bringing a comprehensive range of biosimilar medicines to the market, thereby increasing access for
patients, physicians and pharmacists to affordable medicines and treatments. We are delighted to contribute to the ongoing savings to the Irish healthcare system and supporting patient needs.”
*Supply chain is constantly being optimised and manufacturing location is subject to change.
**Stelara ®. + 29 v 27-gauge needle of the reference product, Stelara ®. ++ 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).
MS Ireland has launched the results of the ‘My MS My Needs’ survey which highlights the challenges faced by the over 10,000 individuals living with multiple sclerosis (MS) in Ireland.
This pivotal research, which builds on a similar survey conducted in 2016, provides critical insights into the challenges faced by the MS community and offers evidence-based recommendations to enhance support and services.
Ms Ava Battles, CEO of MS Ireland, said: "This survey provides invaluable insights that will guide our advocacy efforts and service improvements, ensuring that we continue to meet the evolving needs of the MS community in Ireland.
“We believe these findings will drive positive changes for those living with MS in Ireland. The detailed insights from the ‘My MS My Needs’ survey provide a clear roadmap for addressing the gaps in care and support, ensuring that every individual with MS can access the necessary resources and services.”
Key insights from the survey:
Neurologist appointments: 19 per cent of respondents waited more than six months for their last neurologist appointment.
MRI scans: 68 per cent had an MRI in the past year, with 19 per cent waiting over six months.
Travel for care: 41 per cent travel over an hour (one-way) to see their neurologist.
Neurorehabilitation: Less than 2 per cent accessed services, and 60 per cent are unaware of them.
Care and support: 52 per cent receive help from family/friends; 35 per cent need over 31 hours of care weekly, with 8 per cent requiring full-time care.
Financial strain: Nearly 20 per cent are struggling financially.
The survey, which gathered responses from over 900 people with MS (PwMS), revealed significant
insights into the diverse experiences and needs within the community.
A striking 91 per cent of respondents reported that MS affects their daily lives, with 31 per cent indicating a substantial impact.
Respondents highlighted a range of symptoms and practical needs, with the most frequent challenges being fatigue, mobility issues and cognitive difficulties. Psychological and social impacts, such as mental health concerns and fears for the future, were also significant.
While access to treatments has improved since 2016, many PwMS still face challenges in accessing essential healthcare services, including neurology, physiotherapy, and
psychological support. Notably, 24 per cent of respondents expressed an unmet need for physiotherapy, and 31 per cent highlighted the need for better psychological support.
The survey found that 79 per cent of respondents are currently on a disease-modifying treatment, a slight increase from 75 per cent in 2016.
Based on the survey findings, MS Ireland has developed 10 key recommendations to improve support and services for the MS community. These include addressing regional variations in access to neurology services, and a streamlined process for medical card applications considering the additional financial burdens imposed by the condition.
A new app for people with pulmonary arterial hypertension (PAH) has been introduced through a partnership by Johnson & Johnson Innovative Medicine, the Science Foundation Ireland CONNECT Centre for Future Networks and Communications (CONNECT), Maynooth University, and the Mater Misericordiae University Hospital, Dublin.
This application has been specifically developed using award-winning technology deployed by many UK-based hospitals and is designed to provide essential tools and information for patients living with PAH. The app also enables medical teams to educate patients about their condition and encourages proactive health management.
PAH is a rare form of pulmonary hypertension, which is high blood pressure in the lungs with an annual incidence rate of 3.11 patients per million of the total population of Ireland. Symptoms can severely impact a patient’s ability to carry out normal daily activities. As the disease progresses, some patients may experience constant dyspnoea and fatigue.
The Mater is the national centre of excellence for PAH and is attended by patients from across Ireland. The initial rollout of the app will benefit up to 250 people living with the rare disease who attend the hospital.
The app’s integration into the patients’ care routine is expected to:
Improve the quality-of-life of patients, empowering them to selfmanage elements of their condition through access to credible and localised information about the management of their condition, treatment pathways and online support services.
Improve medication adherence by providing patients with medication support and education.
Reduce hospital appointments by providing patients with self-management information and the use of a health tracker to enable patient-initiated reviews.
Provide holistic guidance and education to patients on their emotional, physical and nutritional wellbeing with the aim of improving their quality-of-life.
Improve the quality of care through personalised, up-to-date medical advice from clinical teams as well as deploying remote education for healthcare professionals through the app.
Enhance the experience of healthcare professionals by streamlining patient interactions and reducing administrative burdens, creating greater efficiencies that benefit both the professionals and the patient.
This partnership brings together the expertise and resources of Johnson & Johnson Innovative Medicine, formerly
known as Janssen, alongside Maynooth University, CONNECT and the Mater to offer innovative support for patients. Developed by Health and Care Innovations, the CONNECTPlus app has been designed in collaboration with nurses, clinicians and PAH patients.
Prof Sean Gaine, Consultant Respiratory Physician at the Mater, said: “Our teams are actively involved in shaping this innovative app to ensure the technology will best suit the needs of our patients and support our goal of empowering people living with PAH to play an active role in the management of their disease. We are delighted to deliver this new innovation to help patients better manage their condition.”
Reduces pain and inflammation to improve physical function
Diclofenac gel provides superior pain relief compared with ibuprofen gel*
Order today 1800 26 26 26
Available in 100g and 50g pack sizes. Always read the label. Suitable for 14+ years.
Indicated for mild to moderate pain from acute strains, sprains or contusions following blunt trauma.
*Wade AG, Crawford GM, Young D, et al. Comparison of diclofenac gel, ibuprofen gel, and ibuprofen gel with levomenthol for the topical treatment of pain associated with musculoskeletal injuries. J Int. Med Res. 2019;47(9):4454-4468.
DICLOMEL MAX STRENGTH 2% w/w GEL. 1 g of gel contains diclofenac as 23.2 mg diclofenac diethylamine corresponding to 20 mg of diclofenac sodium. Presentation: Tube containing white, homogeneous gel. Indications: For short-term local symptomatic treatment of mild to moderate pain in acute strains, sprains or contusions following blunt trauma. Dosage: Adults and adolescents aged 14 years and over: Diclomel Max Strength is used 2 times a day (preferably morning and evening). Depending on the size of the affected site to be treated, cherry to walnut size quantity is required, corresponding to 1-4 g of gel corresponding to 20-80 mg diclofenac sodium. This is sufficient to treat an area of 400-800 cm2. The maximum daily dose is 8 g of gel corresponding to 160 mg diclofenac sodium. Method of administration: For cutaneous use. Contraindications: Hypersensitivity to the active substance or any of the excipients, patients with a history of hypersensitivity reactions, such as asthma, bronchospasm, urticaria, acute rhinitis or angioedema in response to acetylsalicylic acid or NSAIDs, on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes, in the last trimester of pregnancy, in children and adolescents under 14 years of age. Warnings and precautions: The possibility of systemic undesirable effects from application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and over a prolonged period. The gel should therefore be used with caution by patients with reduced renal function, reduced heart function or reduced liver function as well as patients with active peptic ulcers in the stomach or duodenum. Diclomel Max Strength must only be applied to intact, not diseased or injured skin. Eyes and oral mucous membranes must not come into contact with the gel and it must not be taken orally. Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing. If symptoms worsen or do not improve after 3-5 days, a doctor should be consulted. Patients suffering from asthma, hay fever, swelling of nasal mucous membranes (nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory infections (particularly hay fever-like symptoms), and patients with hypersensitivity to painkillers and anti-rheumatic medicinal products of all kinds are rather at risk to asthma attacks, to local skin or mucous membrane swelling (Quincke oedema) or to urticaria than other patients when treated with Diclomel Max Strength. In these patients, Diclomel Max Strength may only be used under certain precautions (emergency preparedness) and direct medical supervision. The same applies for patients who are also allergic to other substances, e.g. with skin reactions, itching or urticaria. If a skin rash occurs with Diclomel Max Strength the treatment should be stopped. Direct sunlight or artificial sun should be avoided during treatment and two weeks after treatment to avoid the risk of photosensitivity. Preventive measures should be taken so that children do not contact the skin areas to which the gel has been applied. Diclomel Max Strength contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. Diclomel Max Strength contains fragrance with eugenol and citral which may cause allergic reactions. Interactions: Since the systemic absorption of diclofenac is very low with topical application, such interactions are very unlikely in use as intended. Fertility, pregnancy and lactation: During the first and second trimester of pregnancy, diclofenac should not be used unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Diclofenac is contraindicated during the third trimester of pregnancy. Diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Diclomel Max Strength no effects on the breast-fed child are anticipated. Because of a lack of controlled studies in breast-feeding women, the medicinal product should only be used during breast-feeding under advice from a healthcare professional. Under this circumstance, Diclomel Max Strength should not be applied on the breasts of breast-feeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time. Driving and operation of machinery: The topical use of diclofenac has no or negligible influence on the ability to drive and use machines. Undesirable effects: Dermatitis (including contact dermatitis), skin rash, erythema, eczema, pruritus. Refer to Summary of Product Characteristics for other adverse effects. Adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Pack size: 50 and 100 mg tubes. A copy of the Summary of Product Characteristics is available upon request or go to www.clonmelhealthcare.ie Marketing authorisation holder: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, Ireland. Marketing authorisation number: PA0126/372/001. Medicinal product not subject to medical prescription. Date last revised: March 2024. Date prepared: June 2024. 2024/ADV/DIC/122H.