IPN 2021 April

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April 2021 Volume 13  Issue 4 PHARMACYNEWSIRELAND.COM

THE INDEPENDENT VOICE OF PHARMACY

In this issue: NEWS: Pharmacy sees Boost on back of Brexit Page 5

COLECALCIFEROL (VITAMIN D₃)

PROFILE: Eoghan talks Evolution of Generations Page 9

REPORT:

BRING SOME

SUNSHINE TO YOUR LIFE

Pandemic taking its toll on Pharmacy Mental Health Page 18

MEDICINES: Know, Check, Ask for Medication Safety Page 23

CORPORATE: Azure Pharmaceuticals Sandra Gannon Exclusive Page 32

FEATURE: Blowin’ in the Wind: Hayfever Page 36

Further information is available from: Galen Pharma Ireland Limited, Finnabair Industrial Estate, Dundalk, Co Louth, Ireland.

Acute Pain in the Pharmacy Setting Page 51

AWARDS:

Legal Classification: POM. MAT-THOR25 CAP-IE-000017

CPD:

Date of Preparation: March 2021

OTC Retail & Pharmacy Product Awards 2021 – Winners Page 56


TREATING ALLERGIC SYMPTOMS IS CHILD’S PLAY WITH1,2† 10mg

Available in 2 formulations: Oral Solution and Orodispersible Tablets*

†*Easy administration - orodispersible tablet is to be placed in the mouth where it disperses rapidly in saliva OR dispersed in water before administration

A non-sedating antihistamine indicated for the symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria in children aged 6 – 11 years with a body weight of at least 20kg1,2 Drynol 10 mg orodispersible tablets and 2.5mg/ml oral solution (bilastine) Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Orodispersible tablets (ODT): round, slightly biconvex white tablets containing 10 mg bilastine. Oral Solution (OS): clear, colourless, slightly viscous aqueous solution. Uses: Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria in children aged 6 to 11 years with a body weight of at least 20 kg. Dosage: Oral administration. Children aged 6 to 11 years with a body weight of at least 20 kg. ODT: Take 1 tablet once daily. OS: Take 4 ml of oral solution once daily. ODT and OS: Take one hour before or two hours after food or fruit juice. Children under 6 years: no information. In adults and adolescents (over 12 years of age) the administration of Drynol 20 mg tablets is appropriate. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings

and Precautions: Avoid co-administration with P-glycoprotein inhibitors in patients with moderate or severe renal impairment. Do not use in children under 6 years of age. Interactions: No interaction data available for children. Consider interactions as for adults: food, grapefruit juice, ketoconazole, erythromycin, diltiazem; medicinal products that are substrates or inhibitors of P-gp, such as cyclosporine. Pregnancy and Lactation: Avoid use during pregnancy. Side Effects: Common: rhinitis, headache, allergic conjunctivitis, abdominal pain/upper abdominal pain. Uncommon: dizziness, loss of consciousness, eye irritation, diarrhoea, nausea, lip swelling, eczema, urticaria, fatigue. Frequency not known: palpitations, tachycardia, hypersensitivity reactions, and vomiting. Pack Sizes: ODT: 30 orodispersible tablets. OS: One bottle containing 120 ml oral solution. Legal Category: POM. Product Authorisation Numbers: PA 865/18/02 and PA 865/18/03. Product Authorisation Holder: Menarini International

Operations Luxembourg S.A, 1 Avenue de la Gare, L-1611 Luxembourg. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC. Date of Preparation: July 2019 References: 1. Drynol 10mg orodispersible tablet Summary of Product Characteristics, last updated March 2019. 2. Drynol 2.5mg/ml oral solution Summary of Product Characteristics, last updated March 2019 Date of Item: January 2021. IR-DRY-02-2021


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Contents

Foreword

Page 5: Ireland employment boost on back of Brexit

One of our leading news stories this issue, shows that medicines scanning under the Falsified Medicines Directive (FMD) is making a positive difference to pharmacy management. This is according to a recent survey by the Irish Medicines Verification Organisation (IMVO), which has recently launched a new website (www.imvo.ie) to provide additional guidance and support on FMD.

Page 6: Medicine scanning under FMD making ‘positive difference’ Page 9: Eoghan Hanly on owning Loughrea’s oldest, and newest, Pharmacy Page 14: Pharmacists start getting their vaccines Page 19: The impact of Covid-19 on pharmacist’s mental health explored

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Niamh Cahill’s exclusive report highlights the shocking reality as to the negative impact Covid is having on mental health. Such was the distress felt by pharmacists that the Samaritans contacted the Irish Pharmacy Union (IPU) last year to inform them of a significant increase in calls from members of the profession.

Page 26: How you can use Social Media to your pharmacy’s advantage Page 32: We talk medicines supply chain issues with Azure Pharmaceuticals’ Sandra Gannon Page 56: OTC Retail & Pharmacy Product Awards 2021 Winners announced

According to Leonie Clarke, General Manager IMVO, this reflects a growing realisation across the EU that the implementation of FMD can support better pharmacy and patient management along with ensuring patient safety by preventing falsified medicines from entering the legal supply chain. Turn to page 6 for the full story.

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Increased workloads, reduced income, Covid-19 infection prevention and control measures, workplace Covid-19 absences and outbreaks, the ongoing infection threat from customers and a slow vaccine rollout have all taken their toll on pharmacy teams in the last 12 months. Turn to page 19 to read more. Elsewhere in this issue we have some fantastic clinical articles, including an overview of Dry Eye Disease, the seasonal ailment that is Hayfever and effective management of urinary tract infections, whilst our Continuing Professional Development module looks at Acute Pain in the Pharmacy setting on page 51.

PUBLISHER: IPN Communications Ireland Ltd. Clifton House, Fitzwilliam Street Lower, Dublin 2 00353 (01) 6690562 MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com

We close the issue with coverage of the OTC & Retail Pharmacy OProduct Award winners for 2021.

EDITOR Kelly Jo Eastwood: 00353 (87)737 6308 kelly-jo@ipn.ie

The OTC and Retail Pharmacy Product Awards are the only industry awards that specifically recognises and rewards the companies and their products within the OTC market.

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ADVERTISING EXECUTIVE Amy Evans: amy@ipn.ie Continued Professional Lead Sibongile Swan Mude swan@ipn.ie CONTRIBUTORS Niamh Cahill | David Kent | Ciara Kirke Theresa Lowry | Kieran Moore Paula Gallagher | Naomi O’Farrell Muriel Pate

PHARMACYNEWSIRELAND.COM

@Irish_PharmNews

IrishPharmacyNews

Irish Pharmacy News is IRISH PHARMACY circulated to all NEWS independent, multiple Pharmacists and academics in Ireland. All rights reserved by Irish Pharmacy News. All material published in Irish Pharmacy News is copyright and no part of this magazine may be reproduced, stored in a retrieval system or transmitted in any form without written permission. IPN Communications Ltd. has taken every care in compiling the magazine to ensure that it is correct at the time of going to press, however the publishers assume no responsibility for any effects from omissions or errors.

They act as a celebration and showcase of product innovation, marketing and value to its customer. All the winners across 19 categories are detailed from page 61 onwards. Congratulations to all the finalists and winning OTC products.

Regulars FEATURE: ALLERGIC RHINITIS TEAM TRAINING: SLEEP DISORDERS CPD: ACUTE PAIN MANAGEMENT FEATURE: URINARY TRACT INFECTIONS FINANCE: PROTECTION POLICIES

FROM

HIGH QUALITY UNIFORMS EXTENSIVE RANGE AVAILABLE FROM SCRUBS TO TUNICS GREAT VALUE FOR MONEY buttercupsuniforms.com | info@buttercupsuniforms.com

P36 P48 P51 P91 P98


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News

Value of Medicines in Ireland Report Innovative new medicines for cancer, heart diseases and respiratory diseases are generating almost €52 billion in socioeconomic value for Ireland over 20 years, according to a ground-breaking new study by the WifOR Economic Research Institute for the Irish Pharmaceutical Healthcare Association (IPHA). The study, ‘The Value of Medicines in Ireland’, is the first thorough assessment of the socioeconomic value of medicines and medicines expenditure. IPHA represents the international originator biopharmaceutical industry in Ireland.

value, according to the study. In cancer, that figure is ¤16.8 billion while ¤9.1 billion is the added socioeconomic value for respiratory diseases.

It shows how society and the economy gain through reduced mortality and added productivity derived from innovation in medicines. Both mortality and morbidity reduce as a result of new treatments.

The total socioeconomic benefit, spread across the three therapy areas, is almost a quarter of modified gross national income, or GNI*, in 2019. It equates to twoand-a-half times the State’s health budget this year. On an annualised basis, the impact is ¤2.5 billion which is more than the State’s ¤2.2 billion spend on medicines in 2019. It represents 22% of the 20-year total expenditure in health. A return-on-investment analysis shows that, for every euro invested in medicines, ¤3.80 will be returned to the economy until 2025.

The study analyses the period between 2005 and 2025, projecting for the remaining four of these years. In that 20-year period, medicines for cardiovascular disease generate ¤25.8 billion in socioeconomic

The study calculates the socioeconomic value of new medicines for the three therapy areas based on avoided years of life lost, on fewer years lived with a disability, and on avoided productivity losses.

The study explores the macroeconomic impact of wealth and health, analysing the three leading causes of death in Ireland in 2019 - cardiovascular diseases, cancer and respiratory diseases.

The analysis shows that, over 20 years, new medicines for cardiovascular diseases result in703,210 fewer years of life lost. It shows 19,416 fewer years lived with a disability. The cumulative socioeconomic impact is ¤25.8 billion because people are more productive for longer. In cancer, the study shows that new medicines result in 470,785 fewer years of life lost over 20 years. It shows 1,943 fewer years lived with a disability. The cumulative socioeconomic impact is ¤16.8 billion, according to the study. In respiratory diseases, 183,397 fewer years of life are lost as a result of innovation in medicines while 71,447 fewer years are lived with a disability. The resulting socioeconomic impact is ¤9.1 billion over the 20-year period. The total impact value over 20 years is ¤51.7 billion. That equates to a per-capita impact of ¤11,000.

Double Pharmacy Excellence LloydsPharmacy were delighted to win the Retail Excellence award at this year’s InBUSINESS Recognition Awards Chambers Ireland. This is the second time in three years that LloydsPharmacy has been recognised with this award which acknowledges the ongoing focus on putting customers and patients first.

“This is a testament to the teams working in LloydsPharmacy stores across Ireland as well as the Support Office teams working together as One Team. This award recognises their relentless dedication and commitment, delivering excellent customer service and patient care throughout communities in Ireland,” Managing Director McKesson Ireland, Paul Reilly, said. Lorraine Brophy, Head of Sales and Retail Operations for LloydsPharmacy added, “This award is even more significant this year as our colleagues have pulled out all the stops to keep our pharmacies open. With new protocols in place, including PPE, social distancing and Perspex screens, they have made patients feel safe and supported at all times. Congratulations to each and every one.” Meanwhile, LloydsPharmacy have recently opened a new store in the Lidl Neighbourhood Centre, Castleknock.

Senior Management attend opening of new LloydsPharmacy store in Castleknock Lidl Shopping Centre

PHARMACYNEWSIRELAND.COM

Amazon secures ‘Pharmacy’ Trademark Global technology company Amazon has successfully registered the trademark ‘Amazon Pharmacy’ with the Intellectual Property Office in the UK. The trademark was registered officially on the 4th December 2020. The UK application was first filed on 9th January 2020. Following the revelation regarding the Amazon Pharmacy trademark application, the Royal Pharmaceutical Society (RPS) stressed the crucial role played by bricks-and-mortar pharmacies, urging patients not to rely solely on online outlets. RPS president Sandra Gidley said: “While the public are increasingly buying online, it is vitally important to note that medicines are not normal consumer items. There is real importance and value in the face-to-face interaction between patients and a pharmacist and this must not be lost. “Each interaction is an opportunity to make a health intervention and to ensure people have no issues with their medicines and are taking them safely.” Amazon sent shock waves through the pharmacy world recently, when the global company announced its plans for rapid expansion into the market. Amazon Pharmacy allows customers to complete an entire pharmacy transaction on their desktop or mobile device through the Amazon App. Customers can add their insurance information, manage prescriptions, and choose payment options before checking out. Members of Amazon Prime can also have access to free two-day delivery and discounts of up to 80% on generic medicines and 40% on prescribed brand-name drugs. When asked if the US launch had implications for the Irish pharmacy market, an Amazon UK spokesperson told Irish Pharmacy News, “This is a U.S.only initiative. “There is significant variation in different countries’ healthcare systems, and various teams across Amazon may drive international innovation tailored to meet the needs of our pharmacy customers in different locations. "We don’t have anything else to share at this time.”


News EMA publish Review The European Medicines Agency (EMA) has published the outcome of a preliminary review of a signal of blood clots in people vaccinated with Covid-19 Vaccine AstraZeneca including information for patients and healthcare professionals. Through its membership of the EMA’s safety committee (PRAC), the HPRA has participated fully in this scientific and evidence based review. The conclusion of the preliminary review is that the benefits of the vaccine in protecting against the significant threat of Covid-19 as a disease, and in preventing hospitalisation and death, continue to outweigh the risk of possible side effects. The initial findings of the review include that the vaccine does not cause an increase in the overall risk of blood clots (thromboembolic events) of a more typical nature in those who receive it. However, at this point, it cannot be excluded that the use of the vaccine may be associated with very rare cases of blood clots accompanied by low levels of blood platelets (thrombocytopenia), which are elements in the blood that help it to clot. These rare cases also include a condition known as CVST (cerebral venous sinus thrombosis). Based on the review, the HPRA emphasises that these are very rare cases. The HPRA will continue to participate in this review with the EMA and other national medicines regulators. To date, no national cases of these very rare blood clots associated with low levels of platelets have been reported to the HPRA. In the region of 2,000 reports associated with Covid-19 Vaccine AstraZeneca have been notified, of which seven describe individuals who have been diagnosed or are being investigated for a blood clotting event after vaccination. These events describe a typical profile of clotting seen at any time in the general population, such as clots in the lung or legs.

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Pharmacy Boost on Back of Brexit Ireland is already seeing a boost for employers on the back of Brexit, according to jobs site Indeed. The company said that UK job recovery is lagging behind Ireland, although that may change as vaccine roll-outs continue. Indeed’s research suggests that EU jobseekers are showing more interest in Ireland-based roles after Brexit. It found that pharmacy, media and the social sciences are all sectors in high demand, potentially because EU citizens are finding it harder to obtain work visas under the UK’s new immigration policy.

Clicks for Ireland-based social science roles, including linguists, archivists and psychologists, grew by 1.6% Indeed also saw an uptick in interest for roles in beauty and wellness, arts and entertainment, pharmacy, sales, sports, childcare, food preparation and service, and real estate.

For media and communications roles, Indeed said that clicks on its site from people across the EU looking for work in Ireland had increased by 3.4% compared to the same time last year. Clicks for similar roles in the UK fell by 0.2%.

“Brexit was a somewhat overlooked event in an extremely tumultuous year, although it has potential to have even longer lasting effects on the Irish labour market,” Jack Kennedy, an economist at Indeed, commented.

“With the UK’s migration policy pivoting post-Brexit, Ireland may stand to benefit. Sectors like media and communications, linguistics, the arts and beauty and wellness are seeing rising interest from EU jobseekers who may have previously been drawn to the UK. “Looking at the hoped-for recovery and jobs market post Covid, data shows job postings in Ireland are down less than the UK compared to a year ago. However, the faster pace of the UK vaccination programme may see its labour market recover quicker in the coming months.”

Digital Pharmacy launches Payment Plan Healthwave, a digital pharmacy service, has launched Ireland’s first pharmacy-led payment plan for long-term contraceptive methods. Catherine McNicholas, Director of Pharmacy Services, Healthwave The digital Pharmacy provided over 100,000 free contraceptive pills for women since launch of service in February 2020. This launch marks the first year of Healthwave’s female-focused initiative that, to date, has provided over 100,000 oral contraceptive pills free of charge to Healthwave members. Currently, over 500 female members of Healthwave digital pharmacy avail of the free oral contraception offer. “Our goal at Healthwave is to simplify access to medications. As the only pharmacy platform to offer a free oral contraception service, we are now seeing the increased demand for LARCs. We are in a position to help women access their preferred form of contraception without the worry of a large upfront payment on top of the insertion fee. We hope our payment plan makes accessing LARC contraception

both easier and affordable for women in Ireland and is one of many exciting initiatives planned for our members.” said Catherine McNicholas, Director of pharmacy services at Healthwave. She continued, “Female health is a key focus for us at Healthwave, with improved access to

contraception at the centre. While we advocate strongly for universally free contraception and welcome calls to introduce pharmacist prescribing of progesterone-only pills, we are fully committed to continuing and expanding our original contraception initiative for Irish women.

United Drug Pharmacy Webinar

In sight of mental health - developing awareness and understanding. United Drug’s Pharmacy Webinar series for 2021 continues on April 13th welcoming Stephen McBride, Director of Services for Aware to discuss awareness and understanding of mental health. The global pandemic has had a huge impact on every aspect of our lives, with particular implications for healthcare in general, and for pharmacy. The United Drug Webinar series provide ongoing business support and valuable industry insights to guide customers in maximising their businesses. Stephen is a chartered counselling Psychologist and Group Psychotherapist with a breadth of experience operationally leading teams and working as a Psychotherapist in the Health Service and Charity Sector. The event takes place at 8pm.

PHARMACYNEWSIRELAND.COM


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News

FMD Aiding Pharmacy Management Medicines scanning under the Falsified Medicines Directive (FMD) is making a positive difference to pharmacy management, according to a recent survey by the Irish Medicines Verification Organisation (IMVO). Leonie Clarke, General Manager, Irish Medicines Verification Organisation (IMVO), at the go live of FMD legislation which further protects patients from the threat of counterfeit medicines. The verification system in Ireland has been in a ‘use and learn’ phase to ensure the continuity of safe supply of medicines to patients while all parties gain a better understanding of the system.

One in four pharmacists surveyed say their FMD software is providing additional data that is helping with the running of their pharmacy. According to Leonie Clarke, General Manager IMVO, this reflects a growing realisation across the EU that the implementation of FMD can support better pharmacy and patient management along with ensuring patient safety by preventing falsified medicines from entering the legal supply chain. IMVO has recently launched a new website (www.imvo.ie) to provide additional guidance and support on FMD. “We know from our engagement that pharmacists, hospitals, wholesalers and marketing authorisation holders (MAHs) have worked hard to meet their FMD obligations. What was encouraging to see from our survey was the wider benefits that a significant number are already experiencing, for example with expiry date tracking. We would be hopeful

that the comprehensive range of guidance available on our new website will support more pharmacists in ensuring smooth and efficient scanning so the added-value from FMD software could be of benefit to many more,” added Ms Clarke. The new website is part of an expanded range of supports that IMVO, the non-profit organisation managing the national medicines verification system for Ireland, is introducing over the coming months to help pharmacies and other users of the system become comfortable with scanning and managing alerts. These include a series of webinars and full details of these will be available shortly on the IMVO website. “We recognised the enormous pressures that pharmacists have been under over the past year by extending the ‘Use and Learn’ phase beyond its original deadline. Now, with the roll-out of the COVID-19 vaccine, like everyone, we would be hopeful that society

and business life will start to return to normal across the second half of the year. While a date for ending ‘Use and Learn’ has not been finalised, we will provide ample notice. In the meantime, we would encourage any pharmacist, hospital, wholesaler or MAH who may require additional support or guidance on the implementation of the FMD or want to find out about our upcoming webinars to visit our website,” Ms Clarke added. The Falsified Medicines Directive (Directive 2011/161/EU) introduced several measures to protect European patients from the threat of falsified medicines, including mandatory safety features on medicine packs that enable their authenticity to be verified by wholesalers, pharmacies and hospitals. These safety features take the form of a barcode containing data unique to the product and an anti-tamper device. IMVO is part of a European-wide network of national medicines verification organisations, all operating national databases connected via an EU Hub managed by the European Medicines Verification Organisation. This advanced and robust verification system holds information about prescription medicines legitimately manufactured and supplied across Europe.

Meaghers Score ‘Best Place to Work’ Accolade Meaghers Pharmacy Group have been awarded the title of one of Ireland’s ‘Best Places to Work.’ The pharmacy chain scooped the accolade within the ‘Small Business’ category. Managing Director Oonagh O’Hagan said, “This is our second year to be named as top Irish workplace and We are particularly proud to move up 11 places and now to be ranked within the Top 30 Best Small workplaces in 2021, all whilst working at the frontline throughout this pandemic and with the very many challenges that we faced every day. “Congratulations to everyone at team Meaghers, your commitment and dedication to our customers across all our communities and to each other has been simply outstanding over the past 12 months.”

PHARMACYNEWSIRELAND.COM

Research on Smoking New research shows that people diagnosed with a genetic condition, called alpha-1 antitrypsin deficiency (AATD), are far more likely to stop smoking and therefore prevent the development of lung disease. The study was led by researchers from RCSI University of Medicine and Health Science. It is estimated that 265,000 people on the island of Ireland are affected by either severe or moderate AATD, but the vast majority of people with AATD have not been diagnosed. Recent Irish research has shown that people with the far more common moderate form of AATD are also at risk of lung disease if they are smokers. With the smoking rate in the general population in Ireland at 17%, this means there are approximately 45,000 current smokers with either severe or moderate AATD who are at increased risk of lung damage due to cigarettes. According to the latest figures from the national targeted detection programme for AATD based at RCSI Beaumont Hospital, 90% of these smokers with AATD remain undiagnosed. The researchers surveyed patients enrolled in the National AATD Registry with a questionnaire relating to demographics, parental smoking history, personal smoking history, AATD awareness and personal medical history. Of the 293 respondents, 58 reported being smokers at the time of their AATD diagnosis. Their subsequent reported quit rate was 70.7%. “Our study has shown that those who receive a diagnosis of alpha-1 antitrypsin deficiency are far more likely to stop smoking. We hope this study will lead to increased testing for AATD, with more people being diagnosed and choosing to stop or completely avoid smoking in order to prevent lung disease from developing,” said Dr Tomás Carroll, senior lecturer at RCSI and the study’s corresponding author. “People with AATD who use electronic cigarettes are also potentially at risk, but more research is needed.”


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Enabling people with depression to feel, think and do better1

Brintellix is indicated for the treatment of major depressive episodes in adults1 Brintellix® (vortioxetine) film-coated tablets Prescribing information: Please refer to the full Summary of Product Characteristics (SPC) before prescribing, particularly in relation to side effects, precautions and contraindications.Presentation: Tablets containing 5, 10, 15 or 20mg of vortioxetine (as the hydrobromide). Indication: Treatment of major depressive episodes in adults. Dosage: 10mg once daily. Dose may be increased to a maximum of 20mg daily or reduced to 5mg if necessary. After depressive symptoms resolve, treatment for at least 6 months is recommended. Can be taken with or without food. Elderly (≥65 years): Initial dosage is 5mg once daily. Caution advised if using doses above 10mg daily as data are limited. Children and adolescents (<18 years): Not recommended as safety and efficacy not established. Cytochrome P450 inhibitors and inducers: Consider a dose reduction of vortioxetine if a strong CYP2D6 inhibitor is added. Consider a dose adjustment if a broad CYP450 inducer is added to treatment. Renal or hepatic impairment: No dose adjustment is needed, however exercise caution given that these subpopulations are vulnerable and data on the use of Brintellix is limited. Contraindications: Hypersensitivity to the active substance or excipients. Concomitant use with non-selective, monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (e.g. moclobemide). Fertility, pregnancy and lactation: Should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus. Limited data on the use of vortioxetine in pregnant women. Animal studies have shown reproductive toxicity. Use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). It is expected that vortioxetine will be excreted into human milk, and a risk to the breastfeeding child cannot be excluded. Animal data showed no effect on fertility, sperm quality or mating performance. Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far. Warnings & Precautions: Closely supervise patients, especially those at high risk, for suiciderelated behaviours during first few weeks of treatment and during dose changes. Use with caution in patients: at risk of hyponatraemia; with a history of mania/hypomania; aggression/agitation; undergoing ECT; with unstable epilepsy (discontinue if seizures begin for the first time or increase in frequency); with bleeding tendencies/disorders, taking anticoagulants or medicines affecting platelet function; in patients on lithium or tryptophan; with increased intraocular pressure, or those at risk of acute narrow angle glaucoma. Monitor patients for appearance of serotonin syndrome or neuroleptic malignant syndrome and discontinue if occurs. Patients may experience feelings of aggression, anger, agitation and irritability. Patients/caregivers should seek medical advice if such behaviour emerges or aggravates. Brintellix tablets contain sodium (<1mmol/tablet). Drug interactions: Alcoholic drinks not advisable. Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6 and to a minor extent CYP3A4/5 and CYP2C9. Potential for interactions with: MAOIs, MAO-A and MAO-B inhibitors; serotonergic medicines (e.g. triptans or tramadol); St John’s wort; products which may lower the seizure threshold, e.g. antidepressants (tricyclic, SSRIs, SNRIs), neuroleptics (phenothiazines, thioxanthenes and butyrophenones), mefloquine or bupropion. Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment. Additionally, these effects may be greater in patients who are poor metabolisers of CYP2D6. A dose adjustment may be considered if a broad

cytochrome P450 inducer (e.g. rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment. There have been reports of false positive results in urine enzyme immunoassays for methadone in patients taking vortioxetine. Exercise caution in interpreting positive drug screen results. Effects on ability to drive and operate machines: No or negligible influence however, as dizziness has been reported, use caution at the start of treatment or when the dose is changed. Adverse events: The most common adverse reaction is nausea, which is usually mild or moderate, transient and occurs within the first two weeks of treatment. The following have been reported in clinical trials and during post-marketing use: Very common (≥1/10 patients); nausea. Common (≥1/100 to <1/10); abnormal dreams, dizziness, diarrhoea, constipation, vomiting, pruritus, including generalised pruritus. Uncommon (≥1/1,000 to <1/100); flushing, night sweats. Rare (≥1/10,000 to <1/1,000); mydriasis (which may lead to acute narrow-angle glaucoma). Not known (from post-marketing reports); anaphylactic reaction, hyponatraemia, insomnia, agitation, aggression, serotonin syndrome, haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding), angioedema, urticaria, rash. Sexual dysfunction: The 20mg dose of vortioxetine was associated with an increase in sexual dysfunction. Class effect: Studies in patients ≥50 years of age, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. Not known if relevant to vortioxetine. Prescribers should consult the full SPC in relation to other side effects. Overdose: Management consisting of treating clinical symptoms and relevant monitoring. Legal category: POM, for non-renewable supply. Brintellix Tablets, blisters of: 5mg (EU/1/13/891/002) 28 tablets. 10mg (EU/1/13/891/010) 28 tablets. 15mg (EU/1/13/891/019) 28 tablets. 20mg (EU/1/13/891/028) 28 tablets. Further information available from: Lundbeck Ireland Ltd, 4045 Kingswood Road, Citywest Business Park, Co. Dublin. Tel: 01 468 9800. Date of last revision of PI: July 2020. Reference: IE-BRIN-0214. Brintellix® is a Registered Trade Mark. Job number: IE-BRIN-0222 Date of preparation: July 2020 Reference: 1. Brintellix Summary of Product Characteristics. Available at https://www.medicines.ie/medicines/brintellix-10-mg-film-coated-tablets-34817/smpc (Accessed: July 2020). Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Lundbeck on: 01 468 9800 Email: SafetyLuIreland@lundbeck.com


Profile

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Evolution through Generations Loughrea Pharmacist Eoghan Hanly is now the proprietor of both the oldest and newest family-owned pharmacies in town. He recently spoke to Irish Pharmacy News about his family’s long-standing reputation within community pharmacy, and describes how he his embracing digital innovation and changing the retail pharmacy landscape.

Eoghan Hanly, Pharmacist/ Proprietor, Killian's CarePlus Pharmacy and Loughrea CarePlus Pharmacy Pharmacist Eoghan Hanly has been a member of the CarePlus Pharmacy network since the early days of the company. The Loughrea man was one of the first pharmacists to join the group, bringing his premises - first established by his grandfather in 1940 - under the CarePlus Pharmacy umbrella.

In February, he marked another major milestone for his family, CarePlus and the retail pharmacy landscape, when Eoghan’s second outlet opened as a fully digital pharmacy - the first of its kind in Ireland and Europe. “The stars aligned for us on this project”, says Eoghan. “We had been considering opening a second, traditionalstyle pharmacy, but when CarePlus Pharmacy began rolling out their Gen2 format and a site with a smaller footprint

became available, it was the perfect solution. “I had been keeping an eye on the evolving plans for Gen2 models and I loved the forward-thinking creativity of it. I knew a couple of other premises in the group had been converted into these new pharmacies over the last year so it was exciting to think we could bring the inaugural ‘digital-first’ project to our customers in Loughrea”. CarePlus Pharmacy opened its first Gen2 outlet in Dunboyne, Co.

Meath last year. Two have opened since, and each of those has been adapted from a conventional pharmacy design into the digital format. Revamped Environments Customers who visit a Gen2 CarePlus Pharmacy now find a transformed and revamped environment. There are no shelves and no baskets cluttering the floor, creating customer bottlenecks. The layout is bright, airy and open, with staff freed up to engage more with customers.

PHARMACYNEWSIRELAND.COM


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Profile

Eoghan now owns both the oldest, and newest pharmacies in Loughrea

A series of large touchscreens invite customers to browse and shop for OTC and front of store products, with features including product information leaflets, ingredients, usage instructions and contraindications available on screen. Another feature of the screen technology is the introduction of recommended or linked products which assist customers along their purchase journey. As a result, the average basket spend per customer across Gen2 pharmacies has increased. Most customers have become accustomed to shopping online within the last 12 months, if not before, and the bright, clear displays make the screens extremely user-friendly, with an easy-to-navigate layout similar to what a customer would see online. The screens can be self-service or assisted service, with staff always on hand to assist people who may need help adjusting to the new format. Once a customer finds what they need on screen, they select it for purchase and the unit prints a docket, which the customer takes with them to the point of sale. Here, they can chat to staff as the in-store robotic technology selects and dispenses their item(s), delivering them via chute to the pay point. The staff member processes the sale and can answer any other questions or queries the customer may have.

“Our digital pharmacy offers all the services a ‘traditional’ pharmacy would, the only difference is how you interact” Engaging with Customers Behind the scenes, a Gollmann robot customised specifically for CarePlus Gen2 pharmacies is looking after the stock. All information regarding stock levels, expiry dates and more is stored in the robot and is fully accessible to staff. The robot acts as an inventory repository as much as a dispensary unit and can rapidly access items selected by customers and deliver to the pay point on the shop floor, adding retail theatre to the customer experience.

Gollmann robots are customised specifically for CarePlus Gen2 Pharmacies

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Besides being quick and efficient, Eoghan says it brings multiple other benefits to the business. “If you walk into a traditional shop, you might see three front of shop staff, but only one can interact, while others are busy with time-consuming manual tasks, such as rotating stock, disinfecting

shelves, carrying out stock control and date-checking. These duties are either eliminated or catered for by the Gollmann robotic system. As a result, the staff are all on hand to engage with and assist customers.” Having stock off the floor and no longer on public display means it can be stored more efficiently, as well as eliminating theft. The current robot units can be located anywhere in store, including in some cases, above pharmacy shops, giving pharmacists the option to take on a premises with a smaller footprint for a lower investment, while offering customers an identical range and level of stock as larger stores. Eoghan says there are requirements that must be adhered to in every pharmacy. “Of course you must have your consultation room, bathroom and wash facilities for staff, a controlled drugs safe, temperature controlled units. Once you factor all that in for a small site, you might not have much space left. That’s where the stacking of the stock in the robot unit comes into its own.” As Eoghan explains, “Our digital pharmacy offers all the services a ‘traditional’ pharmacy would, the only difference is how you interact. There are shelves in the digital pharmacy, but they happen to be virtual rather than physical. We call this a limitless aisle solution.” Although it was in the works for several years, the layout of a Gen2 CarePlus Pharmacy is ideally


11 A series of large touchscreens invite customers to browse and shop for OTC and front of store products

suited to comply with current public health guidelines. Social distancing is comfortable in the absence of shelf-filled aisles and display units. Customers no longer need to reach over each other or queue in confined spaces.

sessions for all staff working in Gen2 format stores to ensure all staff are comfortable to interact with and get the best out of the new technology. Eoghan Hanly says his teams have really embraced the Gen2 technology.

Eoghan says the overall experience is more hygienic. “Social distancing is easier to manage in the Gen2 store as we’re not navigating around shelves and bottlenecks. The staff and customers don’t need to worry about stock or display areas becoming contaminated and the screens are cleaned multiple times during the day.”

“There’s even some joking going on over who gets to try out the new format and who is based in the traditional store. Gen2 removes the tedious jobs for staff and allows them to do what they are trained to do, which is help the customers and fulfil the real role of a community pharmacy. All of our staff have been trained up on the Gen2 format, as we’ll rotate staff across the two premises to cater for longer opening hours in the new outlet”.

Unique Perspectives According to Eoghan, customers at Loughrea's CarePlus Pharmacy have taken to the new format with ease. “The reaction has been overwhelmingly positive so far. We’ve had a few surprised faces when they come in the door, but our staff are well-trained to talk them through the process, which they quickly see is easy to use. For the more sensitive items or concerns, we’ve installed a screen in the consultation room so people can choose items via that screen with the help of a staff member, or simply have a quiet word with staff, as they always would have been able to.”

Eoghan’s grandfather opened his first pharmacy in Loughrea over 80 years ago. In his new position as proprietor of both the oldest and newest family-owned pharmacies in the town, Eoghan has a unique perspective on the realities of the industry, both now and in the future. “More businesses are using the kind of technology you see in a CarePlus Gen2 Pharmacy and the number is going to continue to increase. Fewer retail units will offer the kind of floor space we enjoy in our longer-established outlet in Loughrea, and in this increasingly competitive industry, the more options newly-qualified pharmacists have, the better for their future.”

“In this increasingly competitive industry, the more options newlyqualified pharmacists have, the better for their future”

CarePlus Pharmacy’s Support Office runs in depth training

Gen2 removes the tedious jobs for pharmacy staff

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News

Qualifying during Trying Times Murphy’s Pharmacy in Midleton team member Mary Waters recently qualified as a Pharmacy Technician, graduating from the IPU Pharmacy Technicians course receiving an NVQ LEVEL 3 Pharmacy Technicians Diploma. Mary Waters, Pharmacy Technician, Murphy's Pharmacy snapshot may provide a small insight into life on the frontline. “Having worked for 7 years at the OTC counter I was always interested in the dispensary, how certain drugs worked and what diseases & ailments they were used for. I love engaging with patients, discussing their different medications and helping them if they are unsure about anything.

Jane Fleming, Supervising Pharmacist said, “We are hugely proud of Mary and what she has achieved. She is a key member of the pharmacy team here in Midleton and I am sure this is the only the start of a long and successful career for her within pharmacy.” Mary told Irish Pharmacy News more about her time studying whilst working full time in a busy dispensary, and dealing with a global pandemic. For those of you considering a career as a pharmacy technician, this

“I had the owner of the pharmacy, John Murphy as my tutor in year 1 and in year 2 I had our Supervising Pharmacist Jane Fleming. They were both informative, patient & helpful, and always encouraged me even when I hit a bump in the road to get me back on track!!! The whole team here in Murphys are absolutely amazing, and were so supportive of me in completing this course. “The course itself is very hard work, but looking back now it was worth all the effort. Our first year we had actually training seminars to help us but unfortunately in Year 2 Covid struck and we had virtual training seminars. This was very daunting at the time but in fairness they were very informative, explaining everything, each submission at a time.

“As I work full-time in a very busy pharmacy I did a lot of my course work at home at the weekends and some evenings after work. A lot of the practical course work was actually done while working in the dispensary; things like accuracy checks, making up antibiotics and extemps as well as doing MCQ tests in the office whenever I could get the time. “Covid definitely put extra pressure on. At the very start, back in March, we were split into 2 different teams in the pharmacy which meant we were down to half the staff on a daily basis & had to work tirelessly to get the same workload done. Those were the evenings that I really had to dig deep to complete any course work and meet my deadlines. “Sheer determination and several months later I eventually got there, something that I have to say I am very proud of. Anyone thinking of doing the course should definitely give it a try. Though it is very hard work at times, it is also very rewarding. I am extremely happy now working in our very busy dispensary and hopefully at the end of 2021 I might even get to Graduate properly in style. This will be a very proud moment for me!”

New way to halt excessive inflammation RCSI researchers have discovered a new way to ‘put the brakes’ on excessive inflammation by regulating a type of white blood cell that is critical for our immune system. The discovery has the potential to protect the body from unchecked damage caused by inflammatory diseases. The paper, led by researchers at RCSI University of Medicine and Health Sciences, is published in Nature Communications. When immune cells (white blood cells) in our body called macrophages are exposed to potent infectious agents, powerful inflammatory proteins known as cytokines are produced to fight the invading infection. However, if these cytokine levels get out of control, significant tissue damage can occur.

The researchers have found that a protein called Arginase-2 works through the energy source of macrophage cells, known as mitochondria, to limit inflammation. Specifically they have shown for the first time that Arginase-2 is critical for decreasing a potent inflammatory cytokine called IL-1. This discovery could allow researchers to develop new treatments that target the Arginase-2 protein and protect the body from unchecked damage caused by inflammatory diseases. “Excessive inflammation is a prominent feature of many diseases such as multiple sclerosis, arthritis and

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inflammatory bowel diseases. Through our discovery, we may be able to develop novel therapeutics for the treatment of inflammatory disease and ultimately improve the quality of life for people with these conditions,” commented senior author on the paper Dr Claire McCoy, Senior Lecturer in Immunology at RCSI. The study was led by researchers at the School of Pharmacy and Biomolecular Sciences, RCSI (Dr Claire McCoy, Dr Jennifer Dowling and Ms Remsha Afzal) in collaboration with a network of international researchers from Australia, Germany, and Switzerland.

Clinical Pharmacy Learning Course MSc Clinical Pharmacy is a twoyear, part-time distance learning course specially designed for pharmacists employed in a healthcare setting, who want to enhance their clinical pharmacy knowledge and practice skills. Much of the learning is case-based so scientific and professional elements are integrated. The course is designed to maximise contact between student and tutor while allowing distance learning via the internet and through teleconferences/webinars with experienced medical and pharmacy practitioners. Entry Requirements • Candidates must hold a Primary honours degree (NFQ, Level 8 or equivalent) from a School of Pharmacy that is approved by the Programme Committee; • They must be registered with the professional accreditation authority in the country in which they are practising; • Candidates should have practical experience in their area of qualifications of at least one year post-registration; • Candidates must be employed in a healthcare setting; • Applicants may be requested to undergo an interview; • All candidates will be required to have full access to computer and internet facilities and to be computer literate; • In some exceptional circumstances candidates, by virtue of their training and experience may, at the discretion of the Programme Director and the Head of School, be deemed suitable for entry to the degree under Recognition of Prior Learning (RPL). To be considered for entry to this programme, candidates must have completed their Clinical Pharmacy Postgraduate Diploma no later than five years prior to the date of registration for this programme. The closing date for non-EU applications is 30 June, 2021.


Esomeprazole Krka®

Esomeprazole KRKA

– the right choice for your patients • 100% manufactured in EU • Krka is the leading supplier of generic esomeprazole in the EU, including Ireland • Innovative, patient-friendly pharmaceutical form – capsule with pellets (1)

esomeprazole

Composition Each gastro-resistant capsule, hard, contains 20 mg or 40 mg esomeprazole (as esomeprazole magnesium dihydrate). Therapeutic indications, posology and method of administration Gastroesophageal reflux disease (GERD): Treatment of erosive reflux esophagitis (40 mg once daily for 4 to 8 weeks), long-term management of patients with healed esophagitis to prevent relapse (20 mg once daily), symptomatic treatment of GERD (20 mg once daily in patients without esophagitis. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily.). In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori: Healing of Helicobacter pylori associated duodenal ulcer, prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers (20 mg Esomeprazole Krka with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days). Patients requiring continued NSAID therapy: Healing of gastric ulcers associated with NSAID therapy (The usual dose is 20 mg once daily. The treatment duration is 4-8 weeks.), prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk (20 mg once daily). Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers: 40 mg once daily for 4 weeks. Treatment of Zollinger Ellison syndrome: The recommended initial dosage is 40 mg twice daily. The majority of patients can be controlled on doses between 80 to 160 mg – the dose should be divided and given twice daily. Children below the age of 12 years: Esomeprazole Krka should not be used in children younger than 12 years since no data is available. The capsules should be swallowed whole with some water. The capsules should not be chewed or crushed. The capsules can also be opened and the pellets mixed in non-carbonated water. They can be administered through a gastric tube. Contraindications Hypersensitivity to esomeprazole, substituted benzimidazoles or to any of the excipients. Esomeprazole should not be administered with nelfinavir. Special warnings and precautions for use In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded. Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance. Patients on on-demand treatment should be instructed to contact their physician if their symptoms change in character. Special information about some of the ingredients: Esomeprazole Krka contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Interaction with other medicinal products and other forms of interaction The decreased intragastric acidity during treatment with esomeprazole might increase or decrease the absorption of drugs if the mechanism of absorption is influenced by gastric acidity. In common with the use of other inhibitors of acid secretion or antacids, the absorption of ketoconazole and itraconazole can decrease during treatment with esomeprazole. If the combination of atazanavir with a proton pump inhibitor 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. Monitoring is recommended when initiating and ending concomitant esomeprazole treatment during treatment with warfarin or other coumarine derivatives. Esomeprazole has been shown to have no clinically relevant effects on the pharmacokinetics of amoxicillin or quinidine. Fertility, pregnancy and lactation For esomeprazole, clinical data on exposed pregnancies are insufficient. Caution should be exercised when prescribing to pregnant women. It is not known whether esomeprazole is excreted in human breast milk. No studies in lactating women have been performed. Therefore Esomeprazole Krka should not be used during breast-feeding. Undesirable effects Common undesirable effects are headache, abdominal pain, constipation, diarrhoea, flatulence, and nausea/vomiting. Uncommon undesirable effects are peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, dry mouth, increased liver enzymes, dermatitis, pruritus, rash and urticaria. Other undesirable effects are rare and very rare. Contents of container 28 gastro-resistant capsules of 20 mg and 40 mg of esomeprazole. Legal category Prescription only medicine. Date of revision of the text July 2011 Marketing authorisation holder Krka, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto. Marketing authorisation number PA1347/006/001-002. Further information is available on request. References 1. European patent office. http://ep.espacenet.com/, May 2011.

07/2011, Ireland, 506A-2011, RB.

Gastro-resistant capsules, 20 mg, 40 mg


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News

Vaccination of Pharmacists ‘Pushing Ahead’ Pharmacist and Managing Director of Meaghers Pharmacy Group Oonagh O’Hagan recently received hers and stated, “Many of our pharmacists and myself at Meagher's Pharmacy Group have now received our first dose of the Covid-19 vaccine Meaghers Pharmacy Group MD Oonagh O’Hagan receiving the Covid-19 vaccine

“It’s proceeding well in most parts of the country but we have a couple of blackspots. We’re still pushing to try and get vaccination appointments for pharmacists in Longford and Westmeath. We don’t understand why they have not been vaccinated or given appointments,” he said. “We have that with the HSE to try and get that resolved. Individual pharmacists around the country haven’t been vaccinated yet but the vast majority have. There is a mop up exercise ongoing to identify those missed and get them vaccinated. “We are still pushing hard on pharmacy team numbers and are making steady progress. We are about half way there.” The majority of pharmacists and pharmacy team members have received the Oxford/Astra Zeneca vaccine to date. “The entire process was seamless and the vaccinating team at Health Service Executive in Connolly hospital could not have been more professional. Special shout out to Concepta who really made me feel very much at ease. “The day was filled with optimism and despite all the masks many eyes were smiling at the centre. “I and my pharmacist colleagues are so incredibly grateful to have received the vaccine this week. The pharmacy profession is absolutely determined to now play our part and get all of our patients within our communities vaccinated at speed. “I really feel the end is in sight now and brighter days are ahead.” Meanwhile Cara Pharmacy Group Superintendent Pharmacist Rob Wood shared an image on social media of his vaccination date adding, “Now we're off. Feel like pharmacy was late to the party but onwards and upwards to rolling out vaccinations. All of our colleagues will be able to update their Health Passport Worldwide.” The majority of pharmacists had received their first Covid-19

vaccination by the middle of March, according to the Irish Pharmacy Union (IPU). Further improvements in the level of pharmacy team members vaccinated are being prioritised, according to IPU Secretary General Darragh O’Loughlin. In about 50% of regions nationally pharmacy teams had either been vaccinated or received vaccine appointments by the middle of March.

"Now we're off. Feel like pharmacy was late to the party but onwards and upwards to rolling out vaccinations"

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The second dose of the vaccine is given 12 weeks after the first dose, meaning many pharmacists will not be fully vaccinated when they commence administering vaccinations. The pause in administration of the Oxford/Astra Zeneca vaccine in March due to clotting concerns delayed the rollout of vaccines to healthcare staff and pharmacists. But the HSE has said it is confident it can catch up quickly now that

the vaccine has been given the goahead once again. Meanwhile, at the time of writing, a resolution on discrepancies in rates of pay for pharmacists providing vaccinations in mass vaccination centres (MVCs) had not been resolved, according to O’Loughlin. The Government agreed a rate of pay for pharmacists administering vaccines MVCs but the HSE’s recruitment agency is not honouring the agreement and is instead offering “considerably lower” pay. “We’ve raised that with the HSE a couple of times and haven’t got an explanation as to why that is,” said O’Loughlin. “The issue concerns fees in the vaccination centres only. There is no issue with fees to be paid to pharmacies for doing vaccinations in pharmacies.” The dispute is likely to result in few pharmacists putting themselves forward to work in MVCs. Pharmacists are due to begin administering Covid-19 vaccines in April and the IPU is working closely with the HSE to “get the service rolled out in pharmacies as soon as we can”, said O’Loughlin. “As soon as we have supplies we will do that. We are working towards a target of getting that rolled out in April.” Rob Wood, Superintendent Pharmacist at Cara Pharmacy also received his first vaccine


Speed up your blood flow Ginkgo biloba is a traditional herbal medicinal product used to alleviate the symptoms of poor blood flow in conditions such as cold hands and feet. To get the desired effects, it is essential that you choose a product with a documented content of active compounds.

Warm hands and feet again A thermo-graphic camera can be used to test ginkgo biloba's ability to improve circulation in the hands. When the test subject takes ginkgo biloba, their hands become significantly warmer in the minutes right after they have been cooled down in very cold water.

Your bloodstream carries oxygen and nutrients to every single part of your body – from head to toe – to ensure that all your body functions work properly. However, the flow of blood through the smallest capillaries can decrease for various reasons, and that may cause problems like cold fingers and toes.

35° C 30° C 25° C

Without Ginkgo-Biloba Pharma Nord: After 10 minutes, the skin temperature increased from 12.6° to approx. 20.0° C.

20° C 15° C 10° C 5° C

35° C

With Ginkgo-Biloba Pharma Nord: After 10 minutes, the skin temperature increased from 13.8° to approx. 30.9° C.

30° C 25° C 20° C 15° C 10° C 5° C

Cold hands and feet? This problem may be a result of having poor blood circulation, and the solution could be tablets with ginkgo biloba. Every inch of the body depends on a wellfunctioning blood supply that delivers oxygen and nutrients to the cells. As we humans age, our blood circulation becomes less efficient, leading to problems like cold hands and feet. Supports your blood circulation It stands to reason that ginkgo biloba is so popular among older people. The active compounds in the extract dilate your blood vessels, helping your blood to flow more easily through them.

What is ginkgo biloba? Ginkgo biloba is a plant extract made from the leaves of ginkgo biloba, an ancient temple tree that is also known as maidenhair tree. The extract contains a variety of biologically active compounds. Two specific compounds – ginkgoflavone glycosides and terpene lactones – are particularly well-documented and have been shown to support good blood circulation and good cognitive function. Today, thanks to scientific research that has delved into

the underlying mechanisms of these active ingredients, it is possible to manufacture high-quality extracts that deliver the exact same amount of active compound with each tablet. Ginkgo-Biloba Pharma Nord represents this new generation of pharmaceutical-standard ginkgo biloba products that have become increasingly popular, namely among the elderly.

IE_Biloba_Ad_IrishPharmacyNews_210x297_0920

Ginkgo-Biloba Pharma Nord has a high content of active compounds: The high content of active compounds makes it possible to obtain the desired effect with 1 tablet twice a day. Traditional herbal medicinal product used to alleviate the symptoms of poor blood flow in conditions such as cold hands and feet, exclusively based upon long-standing use. Always read the leaflet.

Tel: 01 899 1650 • Fax: 01 885 3893 ireland@pharmanord.com • www.pharmanord.ie


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News

Question Mark over Patient Access to Medicines Keeping an eye on trends impacting medicines supply to Irish families, Medicines for Ireland (MFI), the Irish pharmaceutical trade association and the supplier of the majority of medicine in Ireland to the HSE and patients directly, has published its most recent report, entitled “Brexit Impact on Imports and Exports of medicines and medical devices in Ireland.” Medicines for Ireland (MFI) Chairperson, David Delaney days. Let’s also re-double our work with the logistics sector to ensure they continue to invest to make the new routes and systems work.

According to Medicines for Ireland (MFI) Chairperson, David Delaney, “The good news is that following continuous consultation with our members we don’t currently anticipate any issues with regard the supply of medicines in Ireland despite experiencing increase in demand. “We are however concerned that the temporary nature of some of the current measures employed by the Government need to be addressed, as they are not sustainable moving forward and they threaten to undermine our ability to supply medicines to those who need them the most. “Further shocks to the supply chain, such as a new variant of Covid-19, could render the current patchwork Government policy inadequate to support our efforts in this regard.” The report highlights the direct impact that Brexit has had on the imports and exports of medicines and medical devices in Ireland, with 90% of Medicines for Ireland member companies reporting delays in importing and exporting since 1st January 2021.

All member companies are experiencing increased pressure on the supply chain, putting patient access to medicines in jeopardy on the island of Ireland, unless stakeholders organise sustainable solutions quickly. Speaking about the report, Mr Delaney said, “Let’s put on record our industry’s thanks for the hard work of officials in the Irish and UK public services leading up to the end of the Transition period. But we need to build on those temporary fixes now to overcome the considerable challenges for Medicines for Ireland (MFI) members who are on the front line of dealing with the impact of new trading routes and procedures and ensuring no impact for patients in relation to access to medicines. “Some of the findings of the report speak for themselves and illustrate the direct impact that the new trading systems has had on imports and exports, with 56% of our members having experienced delays of up to two to three days, since the start of the year. Another 22% of companies have experienced delays of up to five

“Nevertheless, our mission statement remains the same, to keep patients and their families front and centre of our efforts, and this report indicates that MFI member companies have reacted by changing distribution routes to ensure the continued supply of medicines. 73% of respondents have had to change distribution routes into or out of Ireland since 1st January. This disruption to transport routes and changes from the impact of Covid-19 on business operations have led to increased pressures with 91% of respondents having experienced increased costs associated with importing and exporting.” Mr Delaney added: “MFI are continuing to work pro-actively with Government and key policy makers on aspects of policy to ensure round the clock continuity of supply in Ireland. We’re also communicating with the Department of Health and the Health Products Regulatory Authority (HPRA) as well as the HSE, EU Commission and all relevant EU institutions and officials North and South of the border to ensure a solution focused approach is taken to secure a stable supply of medicines to the Irish market.” MFI member companies which include Accord Healthcare; Clonmel Healthcare; Consilient Health; Celltrion; Fannin; Fresenius-Kabi; Nasal Medical; Pinewood; Rowa; Teva and Viatris, contribute significantly to Ireland’s ¤40 billion annual pharmaceutical industry.

Date for your Diary - RCSI Medical Professionalism, supported by the Bons Secours Health System (lead Sponsor) and Medical Protection Society (Picture Competition Session Sponsor) presents their first virtual conference – Professionalism in a Pandemic: Lessons from COVID-19. Friday, 23 April 2021 for a half day of talks and presentations from 12.00-18.00 GMT. The event focuses on professionalism in education and professionalism in clinical practice, and promises to be a day of exciting talks and presentations frm speakers including Professors Richard and Sylvia Creuss, Dr Colm Henry, Prof Samuel McConkey and an international panel from Canada, USA, UK, UAE and Ireland. Registration is FREE but places are limited, so register early to secure your place. Further Details and Registration - https://www.rcsi.com/dublin/news-and-events/events/event/2021/medicalprofessionalism-conference

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RB Rebrands as Reckitt RB has announced this month that it has rebranded as Reckitt. The redevelopment of the corporate identity is a key milestone in the organisation’s ongoing journey of transformation towards sustainable growth. The new brand identity and iconography is more recognisable and is built on the company’s purpose: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. Commenting on the new identity, Jo Osborn, VP Internal Communications and Corporate Brand, said, “From Dettol to Lysol, Nurofen to Durex and Finish to Vanish, we sell more than 20 million of our trusted products to people every day, yet there is less recognition of the company behind those brands. Our new Reckitt identity will better enable us to communicate our corporate purpose to the world, and to do so in a way that is powerful, consistent and impactful.” Rolling out across all of Reckitt’s touchpoints and platforms – internal and external, physical and digital – it comprises: • A new name and logo – the R at the heart of the symbol stands for unity, strength and relentless pursuit, inspired by Reckitt’s purpose to protect, heal and nurture. • An evolved colour palette – the highly distinctive and recognisable ‘Energy Pink’ is Reckitt’s primary brand colour, signifying its perpetual energy – while secondary colours reflect its portfolio of products and connection to a cleaner, healthier world. • Bespoke typography – a new, bespoke typeface ‘Energy’ is distinctive, accessible and unique to the Reckitt brand. • Photography – new photography principles and categories illustrate how everything Reckitt does is connected and has an impact on the world.


News

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Covid Learnings Contribute to Pharmacy Plans Pharmacy regulator launches new Corporate Strategy 2021-2023 The Pharmaceutical Society Ireland (PSI) has launched its latest Corporate Strategy setting out the pharmacy regulator’s key objectives until 2023. Developed against the backdrop of the Covid pandemic, which caused a dramatic shift in the delivery of healthcare services, including pharmacy services, the new strategy recognises the need to enhance the resilience of the sector over the coming years, given its evolving role within the future integrated system. It also sets out the PSI’s plans for developing a more effective regulatory model for community pharmacies which are recognised as a critical part of our healthcare system. The regulator’s ‘digital first’ business transformation programme will also be completed on a phased basis over the lifetime of the plan. “Our role as regulator is to assure the public’s continued trust in pharmacy through effective regulation,” said Niall Byrne, Registrar and Chief Officer, PSI. “The key focus of this plan is to ensure the continued provision of safe, quality pharmacy care within pharmacies and to ensure that pharmacists maintain high standards of professionalism. The healthcare system has been tested this past year like never before. And there have been important learnings, including for the community pharmacy sector, whose position and importance as a highly accessible part of the healthcare system has been very much reinforced. Under this strategy, we are committed to working with stakeholders to help make the pharmacy sector as resilient as possible for the future as well as helping shape the evolving role of the pharmacy sector within the future, more integrated model of healthcare delivery.” The Registrar added, “Significant changes have occurred in recent years in pharmacy practice with the role of pharmacists expanding. The pandemic has led to additional changes and further amplified the benefits of the reorientation of the health system towards integrated care through the implementation of Sláintecare. For our part, we are committed, over the lifetime of this strategy and via the annual service plans that we will develop to deliver it, to actions that will facilitate continued high-quality, and where necessary enhanced, healthcare provision by pharmacists.” “Furthermore, we will continue our work to reform and develop our regulatory frameworks so that we can be the most effective type of pharmacy regulator – one which

adds value for the public without imposing undue burden. A key focus over the next three years will be the continued development of outcome-based standards, such as our Covid-19 Operational Standards, which we developed during 2020. The standards, which are informed by approaches adopted both nationally and internationally, will inform the public as to the standard of care and professionalism which they can expect to receive from a registered pharmacy. Fundamentally, this is about PSI assuring the public that safe systems of care are in place and that these operate within clear accountability structures.” “Ease of engagement is critical to effective regulation, and we are committed to making it easier for our stakeholders to engage with us through a digital-first approach. Our transformation in this regard is well underway and will be delivered on a phased basis, starting with the launch of a new streamlined registration platform in 2021. This new platform will provide registrants with a single online point of contact with the PSI. It will also make it easier for the public and patients to access information on our public register – from details of a pharmacy’s supervising pharmacist to its opening hours.” President of the PSI, Joanne Kissane, described the PSI’s new three-year strategy as providing much needed strategic continuity rather than radical strategic change. “As a regulator, the PSI must be capable of meeting future health requirements. Notwithstanding the more recent and ongoing challenges presented by Covid, Ireland’s healthcare system was already facing several significant challenges, including an ageing population and escalating demand.” “Currently, there are 20+ million visits to pharmacies each year and 80+ million items dispensed annually, and we can expect those figures to rise significantly. By 2030, the share of the population aged 65 and over is projected to grow from one in eight to one in six, while the number of people aged over 85 is projected to

“The key focus of this plan is to ensure the continued provision of safe, quality pharmacy care within pharmacies and to ensure that pharmacists maintain high standards of professionalism” Niall Byrne, Registrar, PSI almost double. Pharmacists have a critical role in delivering safe, effective healthcare services to this changing demographic. The PSI’s role is to ensure that all of this vital healthcare activity is regulated to a high and consistent standard – building our capacity to deliver on this responsibility has been the cornerstone of our recent corporate strategies.” “While the PSI made significant progress under its previous strategy during 2018-2020,

we would have liked to have achieved more. PSI’s plans for 2020, in particular, were significantly impacted by the Covid-19 pandemic. This new strategy continues some of the work already underway while also setting a course for the next three years and recommitting the PSI to its core mission of ensuring safe and reliable care. We are confident that, in partnership with our stakeholders, further and valuable progress on this mission will be made in the coming three years.”

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PRESCRIBING INFORMATION Levetiracetam 100mg/ml oral solution (levetiracetam)

Presentation: Each ml of oral solution contains 100mg Levetiracetam. Indication: Monotherapy in the treatment of partial onset seizures in adults and adolescents from 16 years of age with newly diagnosed epilepsy. As adjunctive therapy: In the treatment of partial onset seizures in adults, adolescents, children and infants from 1 month of age with epilepsy, in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy and in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. Dosage and administration: Route of administration: Oral. Adults: monotherapy: 250mg twice daily which should be increase to 500mg twice daily after two weeks. The dose can be further increased by 250mg twice daily every two weeks depending upon the clinical response. Add-on therapy: 500mg twice daily. Can be increased up to 1500mg twice daily. Dose changes can be made in 500mg twice daily increases or decreases every two to four weeks. Paediatric population: monotherapy: The safety and efficacy have not been established. Add-on therapy: 10mg/kg twice daily, can be increased up to 30mg/kg twice daily. Dose changes should not exceed increases or decreases of 10mg/kg twice daily every two weeks. The lowest effective dose should be used. Elderly: Adjustment of the dose is recommended in patients with compromised renal function. Renal impairment: daily dose must be individualized. Hepatic impairment: 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is <60ml/min/1.73m2. Contraindications: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients. Precautions and warnings: Renal impairment, patients with suicidal ideation and behaviors, depression or behavior emerge. Psychotic symptoms, irritability and aggressiveness. Patients are advised not to drive

Reference:

1. Data on file Levetiracetam 100mg/ml oral solution June 2020 ADV/LVI/PM/0007

Date of Preparation - April 2021

or use machines until it is established that their ability to perform such activities is not affected. Interactions: Methotrexate, macrogol. Pregnancy and lactation: can be used during pregnancy, if after careful assessment it is considered clinically needed. Breast-feeding is not recommended. Undesirable effects: Nasopharyngitis, somnolence, headache, anorexia, depression, hostility/aggression, anxiety, insomnia, nervousness/irritability, convulsion, balance disorder, dizziness, lethargy, tremor, vertigo, cough, abdominal pain, diarrhea, dyspepsia, vomiting, nausea, rash, asthenia/fatigue, infection, suicide attempt, suicidal ideation, pancreatitis, hepatic failure, acute kidney injury. (Please refer to the Summary of Product Characteristics for detailed information) Overdose: Symptoms and signs: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma. Management: stomach may be emptied by gastric lavage or by induction of emesis. There is no specific antidote for levetiracetam. Treatment will be symptomatic and may include haemodialysis Legal category: POM Marketing Authorisation Number: PA22697/012/001 Marketing Authorisation Holder: Syri Pharma Limited t/a Thame Laboratories Floor 0, 1 WML, 1 Windmill Lane, Dublin 2, D02 F206, Ireland. (Distributed by Advanz Pharma Ltd in Ireland) Date of preparation: September 2020 [ADV/LVI/PI/0001] Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Syri Pharma Medical Information via telephone on 00 44 330 1359 422 or via e-mail at medinfo@syripharma.com


Report

19

Taking its Toll Pharmacists and their teams across Ireland have been feeling the pressure. Alarmingly, the Samaritans even reached out to the regulatory body following an increase in calls from the profession. Niamh Cahill reports. In June 2020 the Irish Institute of Pharmacy (IIOP) revealed that 80% of pharmacists were “moderately to highly” stressed. Another survey conducted by the IIOP in October illustrated even greater stress levels among the profession. Such was the distress felt by pharmacists that the Samaritans contacted the Irish Pharmacy Union (IPU) last year to inform them of a significant increase in calls from members of the profession. Increased workloads, reduced income, Covid-19 infection prevention and control measures, workplace Covid-19 absences and outbreaks, the ongoing

“Such was the distress felt by pharmacists that the Samaritans contacted the Irish Pharmacy Union (IPU) last year to inform them of a significant increase in calls from members of the profession” infection threat from customers and a slow vaccine rollout have all taken their toll on pharmacy teams in the last 12 months. In 2020 as pharmacy income fell by about 36% around one in five pharmacies laid off staff with more job losses predicted, an IPU survey showed. The pressure of dealing with anxious and sometimes aggressive patients in pharmacies, some of whom violated guidelines by entering the premises when suffering from Covid-19, has been immense. In the face of such challenges the psychological and emotional wellbeing of pharmacy owners and their teams has come under enormous and continuing strain. An ‘Eye Opener’ to Stress

“So many pharmacists were willing to be involved with such excellent experience and knowledge in mental health so we set up a mental health ambassador group” Alicia O’Dwyer, CPD Quality Assurance Pharmacist at the Irish Institute of Pharmacy (IIOP)

The survey results were “an eye opener to us in some ways,” according to Alicia O’Dwyer, CPD Quality Assurance Pharmacist at the Irish Institute of Pharmacy (IIOP). At the beginning of the pandemic the IIOP reached out to its peer support pharmacist network looking for ways to support the profession. A webinar series was suggested as a way of providing information to pharmacists and to maintain connections within the profession. In particular, it was highlighted that webinars should include clinical and personal development topics, according to O’Dwyer.

give their time to help with mental health and wellbeing initiatives to support pharmacists.” In October last year the IIOP issued another survey to pharmacists on stress levels and their requirements in managing stress. About 370 responses revealed significant stress levels among pharmacists. Results were compared with those received after the June webinar on stress and “we found stress levels were even higher”, says O’Dwyer.

In May the webinar series was launched, commencing with the topics resilience and optimism. “We found it was really popular with pharmacists and after each webinar we asked pharmacists to complete a short survey where we ask them for suggestions for future webinars and support services.” In June, a set of pre-webinar questions issued to pharmacists included a question on stress, asking them to rate their stress level from zero to 10. From almost 250 responses, says O’Dwyer, about 80% of respondents scored their stress levels as “medium to high”. “That was eye opening in some ways and highlighted a high level of stress amongst the profession.” In an effort to respond to the findings, in July the IIOP launched a Covid hub, which included a section on mental health and wellbeing. A mental health working group was established to help design content for the hub. An expression of interest issued for group members revealed a huge desire among pharmacists to get involved, according to O’Dwyer. “So many pharmacists were willing to be involved with such excellent experience and knowledge in mental health so we set up a mental health ambassador group. These are pharmacists that are willing to

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20

Report

The workplace was noted as a significant contributor to stress due to increased workload, inadequate staff levels and increased patient expectations.

“When I saw the results I thought ‘that’s how we were feeling too’. Pressures were definitely being felt by pharmacy staff and their teams.

and the patient was often having the first face to face consultation with their pharmacist. As a profession we tried to spend time with them.”

“We found pharmacists were mainly using personal stress alleviation techniques. Trying to get out for a walk or practicing mindfulness and meditation, or going to counselling.”

“Pharmacy is an isolated profession, particularly when you are working as an independent as we are, with just one store. You are with the same people all the time. You are trying to mind your staff and your business.”

A Profession Neglected

The mental health working group analysed the results and a report was created. A mental health and wellbeing strategy was subsequently developed. The IIOP recently launched a pilot mentoring programme with a view to developing, by the end of the summer, a broader mentoring programme to assist pharmacists. A significant expansion of the Covid hub mental health and wellbeing section with additional resources has occurred, along with the provision of more webinars on wellbeing. Further initiatives and research are planned in the coming months. Isolated Profession Duleek based pharmacy owner and pharmacist Kathy Maher is a member of the IIOP mental working group. She says the institute’s survey results on stress and anxiety were “not surprising”.

As some pharmacists struggled to cope, she says she and her colleagues began to notice in May last year that the predominant conversation with patients was around anxiety and stress. “Everybody was really highly stressed and highly anxious and that hasn’t settled. It hasn’t gone away,” she says. “Not only was the frequency of these conversations noticeable but the intensity of mental health conversations were really increasing, the depths of their distress and the severity with which they were presenting. We had a couple of cases where we had to call crisis numbers from the consultation area because we were so concerned.” What was striking, according to Maher, was that all age groups and both genders were presenting with mental health issues. The worry and stress of Covid-19, social isolation, financial worries and unemployment were some of the concerns raised during consultations. Difficult discussions of this nature placed a heavy burden on pharmacists and staff, many of whom were experiencing hardships of their own, according to Maher. “This has a knock on effect on the pharmacists dealing with these patients…Because we were the only healthcare professional that entirely remained open and accessible that had an impact on ourselves and our teams. It was really intense.”

“We had a couple of cases where we had to call crisis numbers from the consultation area because we were so concerned” Kathy Maher, pharmacy owner and pharmacist, member of the IIOP mental working group

Last year an increase in antidepressants dispensed here was recorded, according to Health Market Research data. Compared to the same time period in 2019, from January to November 2020 antidepressant dispensing rose by six per cent. Maher says in some cases patients unable to access in person consultations with other healthcare professionals visited local pharmacies instead. “The prescription was emailed in

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In January 2021 Secretary General of the IPU Darragh O’Loughlin wrote to Minister for Health Stephen Donnelly urgently seeking extra supports for pharmacy services. Mr O’Loughlin outlined the immense burden on pharmacists and pharmacy teams since the beginning of the pandemic and highlighted the IIOP’s survey results. At the time of writing a response to the IPU’s letter had yet to be received. Mr O’Loughlin wrote: “You and your Department have repeatedly stated that pharmacies have played a pivotal role in the national response to the Covid-19 pandemic, in particular in supporting patients and their access to medicines.

“This has come at considerable cost to pharmacies, both psychologically, with recent research by the Irish Institute of Pharmacy finding worryingly high levels of stress, anxiety and burnout among pharmacists, and financially, with increased hours for existing staff and in many cases staff required to work overtime hours and/or additional temporary staff being brought in to plug gaps caused by Covid-19 infections among staff or the related need to restrict movements as a result of close contact with confirmed cases. “Community pharmacists are performing patient assessments, extending and repeating prescriptions where appropriate to ensure continuity of care for patients whose GPs are unavailable, and have performed a critical role in helping patients in need of medical attention by guiding them towards the services that are available. He went on to highlight a letter issued by the HSE to GPs thanks before Christmas thanking them for their efforts during the pandemic.


21 “No such letter went to pharmacists or pharmacies, all of which have continued to offer a full pharmacy service ensuring the continuation of medicine supplies and essential care during a period when much of the rest of the health system was unavailable.” He argued that “pharmacists are an essential part of primary care infrastructure…and are in desperate need of support. They have, however, so far been neglected.”

“There is certainly no end in sight yet but we’ve got this far. We are further along the tunnel than we were - but there is no light at the end yet”

Struggling to cope According to Maher, many pharmacists, while continuing to work through the pandemic, struggled to meet mortgage payments due to income shortfalls. Front of shop sales used to prop up pharmacy business disappeared due to limits on customer numbers. New counter screens to protect staff, measures to ensure social distancing and personal protective equipment (PPE) spending resulted in costs of between ¤3,000 and ¤10,000 for pharmacies, according to an IPU survey conducted last year.

The survey revealed that staff costs, as well as additional security, delivery and sanitisation costs, increase by an average of ¤5,000 per month, equating to almost ¤10 million per month on average across the sector.

no funding for PPE has been provided yet.

In the absence of Government supports, pharmacies were forced to fund their own infrastructure changes and PPE, despite GPs receiving free protective equipment from the HSE.

Increased costs, reduced income have resulted in some pharmacy owners struggling to meet mortgage repayments while others have reached their credit limit with wholesalers, the IPU has warned.

According to Maher, “despite it being promised from the start”,

O’Loughlin says pharmacists have taken on extra patient work. In an unprecedented development, some pharmacists have even received prescriptions from GPs containing a request to measure the patient’s blood pressure.

This is unlike other jurisdictions, such as Northern Ireland, where Governments have supplied grants to pharmacies to assist with infrastructure changes.

Support As swathes of new information on Covid-19 emerged the IPU did its best to keep members informed, says Maher. At the end of every day for many months the IPU issued an email with information for pharmacists, which Maher says “was a huge comfort”. “You felt they had your back. That was a Godsend.” The IPU has held support seminars for pharmacists “almost weekly” since the pandemic began, according to O’Loughlin.

Pharmacists and staff feeling anxious or stressed can contact the programme and have a confidential conversation with a trained member of the VHI Health team by dialling 1800 995 955. Future Kerry based Pharmacist Dr Jack Shanahan confirmed that as pharmacists continued to work throughout the pandemic they faced immense strain and anxiety, both directly and indirectly, due to Covid-19. But, in his view, pharmacists have not experienced worse mental health challenges than general population, who have also displayed greater levels of stress and anxiety, evidenced by the increase in antidepressant prescribing. “Most pharmacists are seeing the light at the end of the tunnel now with the vaccines being rolled out.” Tomás Conefrey, a community pharmacist based in Dublin, says the feeling among pharmacists in his area was that “we are at a better stage of the pandemic journey now”. “There is certainly no end in sight yet but we’ve got this far. We are further along the tunnel than we were but there is no light at the end of the tunnel yet.” There have been a great deal of “what ifs” and uncertainty surrounding Covid-19, which have negatively impacted the mental health of pharmacists, he believes. Further information Further information on supports is available at https://www2.hse.ie/ services/mental-health-supportsand-services-during-coronavirus/. The Samaritans can be reached by dialling 116 123 .

Several wellbeing supports have been highlighted and provided to pharmacists and their teams throughout the pandemic.

The IIOP Mental Health and Wellbeing section of the COVID Hub is available at https://iiop.ie/ content/mental-health-wellbeing

They include the Practitioner Health Matters Programme (PHMP), an independent service for pharmacists, doctors and dentists experiencing mental health or addiction problems. The confidential helpline number is 01 297 0356.

Resources for pharmacists can be found in the Mental Health & Wellbeing Resources section: https://iiop.ie/content/mentalhealth-resources

The IPU Member Assistance Programme (MAP), in conjunction with VHI Health, provides a free confidential service to IPU members and their staff with information, specialist counselling and support.

IIOP Wellbeing Webinars can be accessed here: https://iiop.ie/ content/iiop-webinars-resources Information to support vulnerable populations at this time, including information about various Support Groups, can be accessed at the following link: https://iiop.ie/ content/vulnerable-populations

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Medication Safety

23

“Know, Check, Ask” for Medication Safety Written by Muriel Pate, Medication Safety Pharmacist and Ciara Kirke, Clinical Lead, Medication Safety, HSE National Quality Improvement Team Each year, adverse drug events are the third most common type of adverse events in the Irish Healthcare system1 with 8.8% of emergency admissions being adverse drug related.2 The HSE’s Know Check Ask campaign aims to reduce medication-related harm through better understanding of medication and communication about it. The medication safety campaign was launched by the National Medication Safety Programme, part of the HSE National Quality Improvement Team, in 2019. The campaign was developed in line with the World Health Organization (WHO) Global Patient Safety Challenge “Medication Without Harm”. The aim of the WHO challenge is to reduce severe avoidable harm by 50% globally over 5 years. As in previous WHO campaigns, such as Clean Care is Safer Care, which focussed on hand hygiene, there is a public awareness component to the programme. Know Check Ask The campaign encourages people taking medicines and their carers or family to: Know your medicines and keep a list Check that you are using the right medicine the right way and Ask your healthcare professional if you’re unsure. My Medicines List

 Reduced inappropriate polypharmacy, through better shared decision-making Optimising the “Know, Check, Ask” Message The HSE’s My Medicines List was based on work previously undertaken in Tallaght University Hospital. The campaign message and proposed draft materials were tested by patient representatives and feedback was sought from patients, advocates, staff and managers at several events such as patient and staff engagement fora and via surveys. Copies were initially distributed from community pharmacies. Large supplies of the leaflet are now available for all settings from HSE Health Promotion. They can be ordered in boxes of 2000 by those who login to the site as a professional to www.healthpromotion.ie Smaller quantities may be requested by emailing safermeds@hse.ie A pdf or Word version of the list is available on www.safermeds. ie , along with other campaign resources including posters and videos.

Muriel Pate, Medication Safety Pharmacist, HSE National QI Team

Ciara Kirke, Clinical Lead, Medication Safety, HSE National QI Team

How can people complete their list?

Consultation with a broad range of stakeholders suggests that both a person’s own list, and a pharmacy or GP generated list may both be suitable options, and that the most appropriate approach will depend on the individual.

People taking regular medicines can: • use the template to complete their own list (with help from a caregiver if necessary). • ask their pharmacist or GP to print a copy of their current medication for them.

Name

Example: ABC Tablets

With traditional medication history taking, Irish research

My allergies and how I react:

My medicines Name of medicine or supplement

Is a medicines list reliable?

Date I filled out this form

Date of birth Strength 25mg

How much I take each time 2 tablets

I take it Once in the morning

I take it every day (Yes / No)

Yes

Why I take it? For my heart

My notes Take with food

The key to the campaign is the use of a medicines list. We are encouraging everyone who takes regular medicines to keep an up-to-date list of their current medication and to take this with them to all healthcare appointments. The use of a medicines list for the person’s own purposes and at healthcare appointments, facilitates:  Improved understanding and communication about medicines, at home, at appointments and at transitions of care, improving safety  Improved adherence, through better understanding and shared decision-making

This document belongs to the person named above. If taking a copy, return the original to the person.

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Medication Safety

Before

you take it…

KNOW your medicines and keep a list

CHECK

that you are using the right medicine the right way

ASK

your healthcare professional if you’re unsure

• Ask the person if anyone helps them with their medicines at home and if they would like for that person to be involved in discussions about their medicines. • Refer to the person’s list when discussing medication, particularly at out-patient appointments and at transitions of care. • If you cannot answer all of a person’s questions about their medication, refer them to someone who can help answer the query, or to appropriate sources of written information. • Consider how you could promote this campaign in your place of work. The list may be helpful when building a medication history.

www.safermeds.ie

has shown that 41% of patients had at least one medication error at admission.3 At the time of discharge 56% of patients experienced prescribing errors and mis-communication.4 People who use a memory aid, such as a medicines list are more likely to be able to recall their medicines accurately than those who do not with 65% vs 21% (P<0.05).5 Messages for people who take regular medicines Why should I keep an up-to-date list of my medicines? Knowing what medicines you take and how you take them helps everyone involved to make correct decisions about your care. Having an up-to-date, written or printed list of your medicines can help: • when you might not be able to remember your medications, for example in an emergency • reduce the chance of errors • when requesting a repeat prescription from your GP. Make sure to keep a copy for yourself! Did you know? You can complete your own medicines list or ask your local pharmacist or GP to print out a copy of your medicines. Tips  Some people find it useful to keep a photo of their medicines list on their phone.

 Another option is to take a photo of your medicines with all the labels in full view.  It can be helpful if you share this list with a family member or carer. Changes to your medicines? Before leaving your appointment or being discharged from hospital: • Ask your doctor, pharmacist or nurse to explain any changes to your medicines. • Find out which medicines to stop, which to continue or which new ones to start. • Keep your list up-to-date by adding any new medicines to the list or drawing a line through any medicines you no longer take. What can I do as a Healthcare Professional? As a healthcare professional, you can engage with people as part of the “Know, Check, Ask” campaign. You can also promote the campaign and use materials in your place of work, using the resources on www.safermeds.ie These are some ideas to get started… • Encourage people to keep an up-to-date list of their medicines and explain why it can be helpful. Suggest that they keep a photo of their list.

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• Transitions of care are a high risk time for medication errors. Take special care to communicate all medication, and any changes, to the healthcare staff who will be continuing the care of the person, and also with the person taking the medication. You may need to verify a person’s medicines list with an additional reliable source, such as contacting the patient’s community pharmacy, residential setting or GP surgery. If there are any differences, return to clarify these with the patient. In addition to the public engagement campaign, there is a parallel message for healthcare professionals to - Know – the medicines they are giving - Check – the five rights of medication (the right patient, the right drug, the right dose, the right route, and the right time) - Ask – discuss medicines with the person taking them. If you wish to promote these messages locally, posters are available on www.safermeds.ie Benefits and outcomes Early engagement at the development phase helped to build partnerships with groups such as Family Carers Ireland, the Irish Heart Foundation and the Asthma Society of Ireland. All are actively involved in promoting the campaign. The My Medicines List and supporting information is now incorporated into the new national handbook for the ‘Discover Diabetes - Type 2’ course and is being employed by co-ordinators for the HSE ‘Living well with a Chronic Disease’ programme. The message to keep a list of your medicines has been incorporated into multiple HSE communications on social media and publications.

The social media campaign to date has featured messages using the hashtag #KnowCheckAsk across Twitter, Facebook, Instagram and LinkedIn. Facebook and Instagram posts featured two videos which have reached over 1 million people. HSE Tweets have reached over 75,763 people to date and the most popular tweet including a direct link to the My Medicines List. The #KnowCheckAsk message has been widely shared and promoted by many organisations, including hospitals, community care organisations, the emergency services, and the campaign has reached an international audience, with requests to adapt the materials from as far as Tasmania. Further Evaluation (Research Collaboration for Quality and Patient Safety) The Know Check Ask campaign is being evaluated by a team at RCSI, having received funding from the Research Collaboration for Quality and Patient Safety (a HSE, HRB and RCPI collaboration). The evaluation will comprise interviews and surveys of health care professionals and people using medicines and their carers. The evaluation seeks to learn from the campaign and how the campaign or other measures could better achieve the goal of reducing medication-related harm and improving awareness and communication about medicines in future. If you are interested in getting involved in this research, please contact Bernadine O'Donovan <bernadineodonovan@rcsi.ie> Conclusion The medicines list can act as a focus for discussions and to help share information about medicines between people using medicines and healthcare professionals. This work can help to improve medication safety in all healthcare settings, and can be helpful as an aid to medicines reconciliation at transitions of care. Where can I find out more? Resources to support the campaign, including posters, a video, and the My Medicines leaflet are available on: www.safermeds.ie Printed supplies of the medicines list can be ordered from: www.healthpromotion.ie. Please login as a professional if you wish to order in multiples of a box of 2000. If you want to order a smaller quantity, email safermeds@hse.ie References on request


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26

Social Media

#R U Social Media Savvy? Are you maxmising your pharmacy's social media potential? Having learned much through supporting over 80 independent member pharmacies with social media planning, Paula Gallagher and Naomi O’Farrell from the central totalhealth support team give us some insight into how independent pharmacies can make the most of social media to engage with their communities.

Paula Gallagher, totalhealth Pharmacy Group, Business Development Manager

Do you know your DMs from your PMs? Could you give someone your ‘handle’ from memory? Do you believe a Twitter Egg is all about Easter?

Naomi O’Farrell, Marketing and Communications Manager, totalhealth Pharmacy Group

There are 3.79 million active social media users in Ireland, accessing their accounts at least once a month (Hootsuite, 2021), so it is safe to assume that a significant percentage of your current and potential customers and patients have social media presence, and that they expect you to have presence, too. This represents a potentially powerful and efficient means of engaging with your target audience; in fact, social media was ranked as the number one means for brands to connect with their customers in a 2018 U.S. survey (SproutSocial, 2018). However, it is not as simple as setting up social media accounts for your pharmacy and sharing special offers; you should have a clear plan for your activity across the most appropriate platforms and tailor that activity to suit your brand and, more importantly, your audience. All the while remembering the obligation to be professional, ethical, and compliant with industry regulations and standards,

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including the PSI Guidance for Pharmacists on the use of Digital and Social Media.

at some of the areas you should focus on when planning a social media strategy for your pharmacy.

The approach taken by totalhealth to social media marketing is centred on each member pharmacy retaining their own personality; we support our members with calendars, planning, content, tools and guidance on social media usage, but local teams have the freedom to tailor the messaging to their audience. You can maximise the impact of social media for your community pharmacy by using a similar approach when planning your strategy. Your audience will not engage in generic content that is clearly not designed for them or for you. It is important that community pharmacies avoid competing with big brands and chains by mirroring approaches aimed at a very different audience; the banter between two national airlines on Twitter might be funny and engaging for their target customer but that probably wouldn’t work in our sector! The key is to carefully tailor your social media content so that it reflects your brand and meets your followers’ expectations. Let’s take a look

What should be your objectives for social media marketing? Social media presence has various potential advantages for your brand and your business, which should inform your goals when designing a strategy: • Increase awareness of your business and the services you provide • Promote your personality and brand values • Staying current, keeping up-todate with relevant trends and competitor activity • A means for your customers to contact you, ask questions or provide feedback • A platform to thank your customers and showcase your team • Attracting new patients and customers • Driving traffic to your website or other social media accounts


27 • Connecting better with your current customers and patients, and learning more about what they want and expect from you • Offering reliable and useful advice and information to your followers • Promotion of events or offers that will interest and benefit your followers. These benefits will only be brought about with a carefully-planned strategy, designed with your desired outcomes in mind. Your Values and Personality What do you want people to associate with your brand? Your social media personality should reflect your pharmacy’s values and approach, and both should be apparent throughout any social media content or activity. This sets the tone for your approach and lets your followers know what they can expect from a visit to your pharmacy. Think about what aspects of your pharmacy are most important to promote and how best to do that through your content. Authenticity is one of the most important things to consumers when connecting with a brand (Ballantyne, Warren, and Nobbs 2006), so consider this when developing your social media personality. Make sure that your profile imagery and descriptions are accurate, appropriate and informative. If multiple team members are involved in social media management, they should all follow the same approach in terms of tone, language and standard of content. What social media platforms should you be active on? The top 5 social media platforms in Ireland are (Hootsuite, 2021): 1. YouTube 2. Facebook 3. Instagram 4. Twitter 5. LinkedIn. Following closely behind those 5 are TikTok, Snapchat and Pinterest. However, when considering what platforms you should have presence on, think about what users typically expect from these platforms and whether they are appropriate for your business. Have your current and target customers and patients in mind while you assess which platform will work best for you. You also need to think about whether you can suitably tailor your content to match each platform, as they each require very different types of content. One of the biggest mistakes to

Michael and Mary from Maher’s totalhealth Pharmacy in Drogheda after getting their first dose of Covid-19 vaccine. Telling the story about your team, allowing your followers to get to know you better, is a big part of what social media is all about

make is to have a social media account for your business that is out-of-date, inactive, or irrelevant to the platform. It is better to be selective about what platforms you use rather than simply re-post links to content across many platforms. Pay close attention to the reception of your content and try to understand the dynamics of your followers so you can adapt your content to match. Whatever platform you use, make sure you use a business profile and not your personal account. What do your followers want to see from you? Social media is just that – social. So successful strategies on any platform will involve active engagement with your followers. When considering social media as part of the marketing strategy for your independent pharmacy, it is important to think about what social media users expect from the brands and companies they follow. The most common reason for using social media is to stay up-to-date with news and current events (Hootsuite, 2021). Covid-19 provided a clear example of how this was of particular relevance to healthcare providers. totalhealth has focused on disseminating public health information on social media in an accessible way, as well as communicating changes in business operations and what customers should expect when they visit the pharmacy. The engagement with these posts was the highest we have seen, reaching over 50% in some cases – the standard engagement level for posts is less than 1% (Hootsuite, 2021). Researching products to buy is the 6th reason for social media use, behind finding funny or entertaining content, filing up spare time, staying in touch with friends, and sharing photos and videos. So, although users are interested in products, it’s important to remember that this is no way the main reason people will choose to follow you. Followers will welcome information and advice that will make a difference to them, as well as getting to know the people behind your brand. Remember the value of authenticity – tell the story of you and your team. What should your social media activity look like? Engagement with the content you post will differ across social media platforms; in general, photo-based content attracts a

higher engagement level, where as video-content is more likely to be shared. The best approach is to ensure you offer your followers a variety of content in different forms, using photo, video, and infographics to convey your messages. Some best practices for activity include: • Make sure your content is appropriate for the platform and also for your pharmacy image • Keep your content relevant to your audience – monitor the level of engagement you experience and adapt your approach as necessary • Vary your content – avoid focusing only on sales or product-focused content; aim for a mix of product, information, advice, fun, team focus, competitions and links • Stay on top of trends and current events; a good example is the recent ‘Jerusalema’ craze, which totalhealth members got involved in with huge interaction from social media followers • Try to stand out from your competitors, not just mirror their approach • Keep your tone casual, lighthearted and fun, without sacrificing professionalism • Do not over-post – you will lose followers by clogging up their feeds with information they do not find engaging • Make sure your content is accurate and up-to-date, especially when sharing health information • Quality is important, particularly when using images or video – if you are creating content yourself, take some time to develop the necessary skills to ensure it reaches a suitable

standard. Content that is unique to you is always preferable to sharing the content created elsewhere, such as branded infographics or videos of your team, but only if of a high enough quality • Take care with spelling and grammar, and avoid digital faux pas, such as writing in all capitals or over-use of hashtags • Carefully review your content for appropriateness and sensitivity, considering any potential implications or interpretations of your message – aim at all times for equality, inclusivity and diversity. Don’t forget about your content once it’s posted; ensure you monitor your posts for ongoing reactions, aiming to further enhance connections by engaging with your audience. You can achieve this by: • Starting and participating in conversations • Asking and answering questions • Commenting on posts and responding to comments • Sharing content generated by your followers, your suppliers, businesses in your local community or other connected organisations • Addressing any complaints or criticism • Showing your followers and your customers that you appreciate them. Managing your Social Media activity All these considerations may seem daunting, particularly when you have to tailor your content for each platform. But you can be clever about adapting your content so it is relevant across platforms. For

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Social Media example, sharing an information graphic on Facebook will benefit from an introductory post as well as the graphic, perhaps with a link to further information. If your graphic is of high enough quality, you can share it on Instagram. And for Twitter, simply adapt your post to match the snappier Twitter style. Whatever you do, avoid simply re-posting across all platforms as it can be interpreted as being lazy. Ways to help manage your social media strategy include: • Create a promotional calendar for your marketing efforts, bearing in mind seasonal trends and significant events • Prepare and schedule your posts in advance – this ensures you can proof them and plan a suitable timeframe to allow for variety on your social media pages • Consider the use of a socialmedia online software, such as Hootsuite, which will allow you to manage all of your accounts from one place • Make sure you have the appropriate resources to manage your social media activity – you might consider delegating management to someone with a better skill set or more time. Your followers should feel comfortable about sharing complaints or criticism on social Nial from Tully’s totalhealth Pharmacy in Castlerea showing his fun side while presenting a customer prize – social media users appreciate fun and getting to see your personality!

media – in fact, such feedback should be welcomed and seen as an opportunity to improve. Make sure to deal appropriately with any negative feedback but avoid engaging with ‘trolling’ behaviour – social media users who make extreme or offensive comments just to get a rise from others. You should delete such comments immediately and report the user. If ignored, you risk causing offence to your genuine followers and jeopardising the integrity of your pharmacy’s image. Measures of Success The totalhealth Pharmacy Facebook page had just over 700 followers in 2016. Currently, over 26,000 people now follow the page, with reach growing across other social media platforms. But a successful social media approach is not measurable by followers alone. Although it is obviously worthwhile to increase your reach as much as possible, it is of little benefit if you are not attracting interest from current and potential customers and patients. Most platforms offer useful insight functions that will help you analyse how your content is being received. Take time to learn about the tools available on each platform and assess the level of interaction and engagement you are generating with your goals in mind. Engagement with your content in the form of commentary and sharing is hugely beneficial in increasing awareness of your pharmacy, so learn what your audience is most interested in and adapt your approach to maximise this.

News McKesson Ireland March for Miles For their second companywide charity initiative, the staff of McKesson Ireland came together to “March Miles for Aware” during the week of March 13th – 20th. McKesson Ireland consists of four leading Irish Healthcare Businesses that include United Drug, Lloyds Pharmacy, Median Healthcare and TCP Homecare. Aware was chosen as the new charity partner last October after a companywide vote and a period of research and consultation with staff.

Taking part in a 5 mile virtual walk/ run, the McKesson Team took to the paths to get outside and enjoy some fresh air which as we all know is so vitally important for our mental health. Sadly 1 in 10 people in Ireland experience depression and in these difficult times, Aware

need extra funds now more than ever. McKesson Ireland joined forces with Aware as their official charity partner in 2020 to offer as much support as they possibly could to help ensure Aware can continue to provide the vital, free services

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it provides for individuals and families impacted by depression, anxiety and bipolar disorder. The McKesson Ireland Team have so far raised a fantastic ¤21,492 for Aware and are still collecting donations for their current 5mile

initiative. A big thank you to all who participated and took the time out of their week to complete their 5miles. For anyone who would like to offer a donation to the ongoing McKesson Ireland Charity Partnership or if you would simply like to follow our ongoing leaderboard, you can do so using the following link for our dedicated JustGiving Charity microsite: https://mckesson. blackbaud-sites.com/


Help your customers break the habit this Lent

Acts fast and lasts for hours* *based on 25% reduction in cravings at nearly 3 hours Nicorette Icy white 4mg Medicated Chewing Gum. For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit. Helping smokers temporarily abstain from smoking . In smokers currently unable or not ready to stop smoking abruptly. Gum may also be used as part of a programme to reduce smoking prior to stopping completely.. Dosage: Smoking cessation: The gum should be used whenever there is an urge to smoke. Not more than 15 pieces of the chewing gum may be used each day. If not successful after 12 weeks the patient should be encouraged to make a fresh attempt to stop smoking. Temporary Abstinence: See full prescribing information. Gradual cessation: See full prescribing information. Contraindications: Use in non-smokers, Use in persons hypersensitive to nicotine or any ingredient in the formulation. Special Warnings and Precautions: The benefits of quitting smoking outweigh any risks associated with correctly administered NRT. A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions: - Cardiovascular disease: Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, recent cerebrovascular accident, and/or who suffer with uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicorette Gum may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision. Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects. Gastrointestinal Disease: Nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and NRT preparations should be used with caution in these conditions. Phaeochromocytoma and uncontrolled hyperthyroidism: Nicotine, both from NRT and smoking, causes the release of catecholamines from the adrenal medulla. Therefore, Nicorette should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma. - Diabetes Mellitus. Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when smoking is stopped and NRT is initiated, as reductions in nicotine-induced catecholamine release can affect carbohydrate metabolism. Patients with diabetes mellitus may require lower doses of insulin as a result of smoking cessation. - Smokers who wear dentures may experience difficulties in chewing Nicorette Gum. The chewing gum may stick to and may in rare cases damage dentures. Transferred dependence: Nicotine in any dose form is capable of inducing a dependence syndrome after chronic use and is highly toxic after acute use. However, dependence with Nicorette Gum is a rare side-effect and is both less harmful and easier to break than smoking dependence. Danger in children: Doses of nicotine tolerated by smokers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be handled or ingested by children.. Undesirable Effects: See full prescribing information for full list of undesirable effects. Immune System Disorders: Hypersensitivity - Common Anaphylactic reaction - Not known. Psychiatric Disorders – Abnormal Dreams – Uncommon. Nervous System Disorders: Headache - Very Common, Burning sensation, Dysgeusia, Paraesthesia – Common. Eye Disorders: Blurred Vision, Lacrimation increased – Common. Cardiac Disorders: Palpitations, Tachycardia - Not known. Vascular Disorders: Flushing, Hypertension – Uncommon. Respiratory, Thoracic and Mediastinal Disorders: Cough, Throat irritation - Very common. Bronchospasm, Dysphonia, Dyspnoea, Nasal Congestion, Sneezing, Throat tightness – Uncommon. Gastrointestinal Disorders: Hiccups, Nausea - Very common. Abdominal pain: Diarrhoea, Dry mouth, Dyspepsia, Flatulence, Salivary hypersecretion, Stomatitis, Vomiting – Common. Eructation Glossitis, Oral mucosal blistering and exfoliation, Paraesthesia oral – Uncommon. Dysphagia, Hypoaesthesia oral, Retching – Rare. Dry throat, Gastrointestinal discomfort Lip pain - Not known. Skin and Subcutaneous Tissue: Hyperhidrosis, Pruritus, Rash, Urticaria Disorders – Uncommon. Erythema - Not known. Musculoskeletal and Connective Tissue Disorders: Pain in jaw – Uncommon. Muscle tightness - Not known. General Disorders and Administration Site Conditions: Fatigue – Common. Asthenia, Chest discomfort and pain, Malaise – Uncommon. Allergic reactions including angioedema - Rare. MA Holder: Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland. MA Number: PA 330/37/9 Date of Revision of the Text: June 2018. Legal Category: Products not subject to medical prescription. Further information available upon request from Johnson & Johnson (Ireland) Ltd. IRE/NI/20-4096


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News

Reducing Risk of PPE Injuries for Pharmacy A new study has found that a new 'care bundle' can reduce the incidence of facial pressure injuries in frontline Covid-19 healthcare workers such as pharmacists, caused by the prolonged wearing of Personal Protective Equipment (PPE). The research took place over a two-month period amongst healthcare workers in a large acute hospital in Ireland. In the study, approximately 300 frontline staff were provided with a care bundle, which was designed in line with international best practice and consisted of face cleansing material (WaterWipes® baby wipes), moisturising balm (Eucerin Aquaphor Soothing Skin BalmTM), and protective tape (Mepitac TapeTM).

Natalie McEvoy in PPE

Natalie McEvoy demonstrating PPE facial injuries

Results showed that prior to using the care bundle 29% of respondents developed a facial pressure injury, whereas after using the care bundle only 8% of respondents developed such an injury. The analysis revealed that when using the care bundle, staff were almost five times less likely to develop a facial pressure injury. In a secondary finding, respondents reported the bundle as easy to use, safe and effective. Professor Zena Moore, Director of the SWaT Research Centre and Head of the RCSI School

of Nursing and Midwifery, was lead researcher on the study. Prof Moore said, "We are acutely aware of the facial injuries, such as pressure ulcers, bruises and skin tears that healthcare workers are experiencing due to the prolonged wearing of protective equipment during the pandemic and especially the wearing of medical face masks. These injuries can be painful for staff and injuries in some cases can put them at increased risk of infection. This study is the first of its kind carried out at the height of the pandemic in an effort to help mitigate the occurrence of Facial Pressure Injuries. The results tell us that when skincare is prioritised, and a systematic preventative care bundle approach is adopted, there are clear benefits for the frontline workers and the workplaces involved." The study, led by researchers from RCSI University of Medicine and Health Sciences Skin Wounds and Trauma (SWaT) Research Centre, is published in the current edition of the Journal of Wound Care.

United Drug Webinar Series - Macro Floor Planning 2021 Review As part of the United Drug monthly webinar series to support the Retail Pharmacy sector to grow and optimise their Businesses, United Drug welcomed customers back in March for the topic of Macro Floor Planning for 2021. They welcomed their very own Mary Magner, United Drug’s Category Manager who gave an expert guide on how to embark upon a floor plan review to optimize your store layout. Mary Magner, United Drug Category Manager

2020 was an unprecedented year for modern retail. With the vaccination rollout this year and a hopeful return to a 'new normal' for retail, it is a good opportunity for pharmacies to look at their retail layout with fresh eyes and also take learnings from this most unusual past year. Key Takeaways from this webinar included: 1) Why embark upon a floor plan review 2) Explanation of the process and steps that we take when conducting a review

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3) How to approach a floor plan for a green field site or post major renovations 4) Most common missteps seen in retail pharmacies in terms of macro layouts 5) How to incorporate learnings from trading through the pandemic into a review of a macro layout If you missed out on the webinar and would like to recap with a recording, please contact the event organiser via email: lucia. mariaonofri@united-drug.com



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Corporate Profile

The Future is Bright Azure Pharmaceuticals, headed up by generics industry leader Sandra Gannon, mark three years in bringing a new dynamic to medicines Azure Pharmaceuticals have just marked a milestone; having entered the Irish market in March 2018 the team are now three years in operation. We spoke to Managing Director Sandra Gannon about their growth and the opportunities for the future. The management team behind Azure Pharmaceuticals have decades of experience in the European medicines market and were to the fore in bringing generics to the market in Ireland; they were later instrumental to the significant growth of the generic medicine usage. “Having spent over two decades working in the generics market in Ireland and abroad, it became clear to me that the need for ever

greater efficiencies in the global pharmaceuticals supply chain were leading to a growing number of out of stocks in small volume markets, and in many cases, a greater reliance on unlicensed medicines (EMPs),” Sandra explains. Unlicensed Medicines “Therefore, Azure’s initial focus was on resolving, where possible, the volume of unlicensed

medicines that was being dispensed to Irish patients, and also, those medicines with continuous supply interruptions. “Over the past three years, Azure has brought six licensed medications to market to replace long term EMPs, including Bendroflumethiazide tabs, Colchicine tabs, and Amitriptyline 10mg tablets. In the hospital setting too, we launched Carmustine injections in

“As the focus of payers and healthcare professionals move to newer and more expensive medicines, the prices for older medicines have been consistently reduced, while the cost of regulation has unerringly risen”

late 2020. Every month, we supply over 45,000 packs of licensed medicines to Irish patients replacing previously unlicensed ones. “Azure also has an operation in Malta, distributing and marketing off-patent medicines for the private and tender market. It is an interesting market, in terms of its evolution toward greater use of generics and also the changes which are happening as a result of Brexit, given that Malta has had a high dependency on UK supply.” As well as the aforementioned key products, Azure has also launched a range of older, off-patent medicines which are supplied by a single source. Included in this range are Mebeverine Azure, Naproxen Azure and Fexofenadine Azure, all of which were launched in Ireland in the past 6 months. “There are three further launches planned for quarter 2 of this year, and we have a pipeline of eight additional molecules currently undergoing regulatory approval, the majority of which will launch in 2022,” Sandra adds. Medicines Pricing “All of these new launches are similar in nature – older, off-patent products which are still seen by physicians as staples in their arsenal, and are used by tens of thousands of Irish patients each year. As the focus of payers and healthcare professionals move to newer and more expensive medicines, the prices for older medicines have been consistently reduced, while the cost of regulation has unerringly risen.

Azure Pharmaceuticals Managing Director Sandra Gannon

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33 “As a result, the number of suppliers has, in many cases, dwindled to one single supplier. The latter scenario has increased the risk of shortages, if that last supplier then itself experiences manufacturing issues. We did an analysis of the shortages reported to the HPRA in 2019/20 and some 26% of all shortages were for single source off-patent molecules demonstrating that reliance on one manufacturer is a key contributor to unavailability of older medicines.” The pharmaceutical industry, not just in Ireland but worldwide can be difficult to navigate, Sandra reflects. But key to the success of Azure so far has been their entrepreneurial and commercial drive, coupled with the ability to be responsive, nimble and agile in terms of focus. “We’re still quite young but we’re incredibly proud of what we’ve achieved in such a short space of time. Operating in the pharmaceutical industry is not for the faint hearted – complex regulations, exacting quality standards, pricing pressures, supply chain challenges, and fierce competitive dynamics all help to make for an interesting day. Marking Success “Unlike a multinational pharmaceutical company, which often has cumbersome reporting and approval lines to EU or global headquarters, every decision in Azure is made locally and with the best interests of the Irish market in mind. The management team are highly skilled and have decades of experience in the Irish medicines market and are determined to create a new dynamic in the Irish medicines market.” At a time when many organisations and companies are working remotely, operating at limited capacity or shut down completely, it may seem like there are few, if any, opportunities to achieve business growth. Despite these setbacks, there are ways to make the most of the current circumstances and continue growing as the team at Azure Pharmaceuticals have been discovering. “Suffice to say that establishing a business in the middle of a global pandemic isn’t ideal. And I’m very conscious that some businesses, particularly in the hospitality sector, will fail to make it through. So I’m extremely proud of what we’ve managed to achieve

particularly given the challenging circumstances we found ourselves operating in,” Sandra notes. “Despite declining sales of antibiotics, respiratory medicines and many cough/cold remedies, the prescription market in terms of Azure’s portfolio held up well in 2020. “Knowing that Irish patients are able to access licensed versions of medicines, that for many years have been EMPs, gives us tremendous job satisfaction and knowing that this benefits prescribers, pharmacists and the HSE in terms of reducing the administration burden is also rewarding.” “Becoming MAH for our own range of Azure generics, combined with the growth of our distribution business in Ireland and Malta – whilst managing the combined challenges of Covid-19 and Brexit - has been a noteworthy achievement for us in the last year.” 2020 and 2021 were years already predicted to present the sector with challenges. With its global and highly regulated nature and highly complex supply chains, the sector was always going to face considerable challenges as a result of Brexit. And not forgetting the Falsified Medicines Directive. Sandra continues, “Challenges such as funding for new medicines, the complexity of FMD, and even Brexit with all its worries, pale into insignificance if the face of a global pandemic. “The pandemic triggered a fear that the global pharmaceutical supply chain would crumble. In practice, it has proved relatively resilient, mainly due to the long lead-time required for manufacturing, but a number of weaknesses have been exposed that must be addressed for the future. “For example, Covid-19 has highlighted the pharmaceutical industry’s over-reliance on China and India for raw materials, active pharmaceutical ingredients and increasingly finished products. Any lasting disruption to these markets will have real impacts further down the supply chain. Covid has demonstrated the need for pharma companies to have multiple sources of supply spread across different geographies, which only serves to add complexity to an already extremely complex supply chain.

Strategic Partnerships

The Three P’s

“Medicine shortages in the Irish and global markets are not new phenomena, but they have become a much larger issue in recent years. Internationally, it has been termed “pharma famine”, and it often occurs because of manufacturing issues which then interrupt the global and Irish supply chains.

Despite Covid-19’s arrival, the company succeeded in launching eight products in 2020.

“Ireland is particularly vulnerable because of its small market size, increasingly low prices for offpatent medicines which results in a lack of multiple suppliers. “For patients, medicine shortages are more than just an inconvenience: they can have detrimental impacts on their treatment regimes. Pharmacists are spending increasing amounts of time trying to source alternative medicines rather than consulting with patients on their overall health. “From the perspective of the HSE and taxpayers, when medicines are out of stock the HSE is often forced to use unlicensed medicines to meet patient needs. These can cost multiples of the original out-of-stock medicine. “To address these issues, Azure has established several strategic partnerships with global manufacturers to re-introduce these medicines to the Irish market and to offer alternative supply for single-source, older medicines to pharmacists and the HSE.”

Sandra is adamant. Perseverance is absolutely key. “Thankfully, much of the regulatory and operational effort required to achieve this remained relatively unaffected by lockdown. On the other hand, sales activity has been extremely curtailed. And whilst I’ve no doubt that some of the adaptations the industry has made to the way we do business to counter the lack of face-toface contact with customers and suppliers will continue, it will however, be great to meet in person again soon – hopefully.” It has been said that consumers are now turning to brands they trust, those that are established with strong heritage and that are grounded in science. How has Azure Pharmaceuticals managed to ensure brand strength and recognition? “I think the reality is much more nuanced. Brand loyalty, particularly in the OTC space, has always been strong. However, more and more, consumers are also seeking value for money. “In the case of prescription-only medicines, consumer choice is less of a factor, as the choice is made by the physician, and in many instances can be substituted by community

“Every decision in Azure is made locally and with the best interests of the Irish market in mind. The management team are highly skilled and have decades of experience in the Irish medicines market and are determined to create a new dynamic in the Irish medicines market” PHARMACYNEWSIRELAND.COM


34

Corporate Profile

“For patients, medicine shortages are more than just an inconvenience: they can have detrimental impacts on their treatment regimes. Pharmacists are spending increasing amounts of time trying to source alternative medicines rather than consulting with patients on their overall health” pharmacy. All prescription-only medicines are grounded in science in the form of clinic trials and regulatory dossiers; they are manufactured and tested to the strictest standards of compliance; protected from counterfeiting in the form of FMD legislation; transported and stored under temperature controlled conditions, and are monitored on an ongoing basis for adverse event signals. “Azure products fully adhere to all these requirements. We think our approach to the market,

seeking out niche products and bringing licensed versions of older medicines to market, differentiates Azure from other companies in the off-patent space and that our customers see the benefits that our strategy has to offer.” In looking at community pharmacy within Ireland, Sandra highlights what she believes are the key challenges for 2021. “In terms of opportunities, community pharmacy’s involvement in the Covid-19 vaccine rollout provides a great

platform to demonstrate how well place they are to deliver a much broader range of primary healthcare services, should the government choose to fund these. “A major challenge is the need to grow their online business. Again, the global pandemic has forced us to change the way we shop. With Irish online sales reaching 15% of all retail sales in April 202, up from pre-pandemic levels of 3.5%, online shopping is here to stay. Some retail pharmacies have yet to harness this opportunity.

“Our aim is to continue to work with stakeholders to tackle these supply issues. Feedback from pharmacists on Azure’s proposition has been overwhelmingly positive.” With a well-established career within generics and pharmaceuticals, Sandra is obviously well placed to continue taking Azure forward. “In terms of our business model, we understand the dynamics in medicines market here and where the weaknesses are and will be in the future. We will bring a new focus to this part of the market and in doing so, deliver better service and value to the State and healthcare professionals. “For patients, our products will grant greater access to essential medicines. “As a new company, with an ability to be agile and innovative, we believe that we can make a significant contribution to address supply issue.”

News Postcode lottery could slowdown vaccine rollout Pharmacists criticise inconsistent approach to prioritisation in vaccinating pharmacy staff The rollout of the Covid-19 vaccine in Ireland could be slowed down by a ‘postcode lottery’ that has developed within the HSE. This warning was issued by the Irish Pharmacy Union (IPU) who say there is an inconsistent approach to vaccinating priority groups, including pharmacy staff, in different parts of the country. “While a number of pharmacy staff, as essential frontline workers, have now been vaccinated, there are inexplicably some areas of the country where there has been little, if any, vaccination of this key cohort”

IPU Secretary General Darragh O’Loughlin outlined their concerns, saying, “While a number of pharmacy staff, as essential frontline workers, have now been vaccinated, there are inexplicably some areas of the country where there has been little, if any, vaccination of this key cohort. This is completely unacceptable and, if allowed to continue, could have a serious impact on the rollout of vaccinations in those areas. “This has resulted in these essential workers being unfairly treated depending on where they are based,” which according to Mr O’Loughlin, “places each of them at increased levels of risk. Pharmacies have remained open from the earliest days of the lockdown, providing essential healthcare and ensuring the continued supply of medicines. The failure to protect all pharmacy staff is causing huge frustration and anxiety.

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“Pharmacists will play a key role in the vaccine rollout, with this due to commence in the coming weeks. It is unreasonable to expect pharmacies to open their doors to vaccine clinics without having protected their staff first. Failing to protect pharmacy staff could therefore slowdown vaccine administration to the wider population in these parts of the country.” Mr O’Loughlin concluded by calling on Minister Stephen Donnelly to intervene to address this issue; “This unexplained discrepancy is placing healthcare workers at an unnecessary risk and it has the potential to undermine the pace of the vaccine rollout in affected areas. Resolving this should be a priority for the Minister and we hope he can bring clarity to the situation without delay.”


MEDICINES MORE SSURED

Our purpose is to safeguard the medicine supply chain to ensure that older medicines at risk of going out of stock remain available and affordable. 26% of all notified shortages (Oct 2019 - March 2020) were single source, off-patent medicines.*

It makes sense to support a second source sarah.corry@azure-pharma.com National Accounts Manager

www.azure-pharma.com *Azure own data

Date of Prep (03/02/21) | Job Bag No. (Azu02/21)


Blowin’ in the Wind News of a ‘Pollen Bomb’ has many running for cover. Is your pharmacy ready for the next onslaught of hayfever season?

O

ne in five Irish consumers suffer from hayfever, but they face more misery as experts are warning that the pollen season could start this year - and last three weeks longer.

EFFECTS OF CLIMATE CHANGE

Hayfever sufferers are being advised to prepare to prevent onset of itchy eyes and runny noses, this despite the recent cold weather.

New research has found it's made the season around three weeks longer than 30 years ago. What is more, there is over a fifth more pollen in the air - and the amount is going up.

The switch from low temperatures to potential highs of 17C could see clouds of allergens released into the air. Those affected by hay fever are being told to prepare for the worst case hay fever scenario. Most people with the irritating condition are allergic to grass pollen, which is usually worst between May and July. For others, it's tree pollen which starts to come into season around February and typically ends around June. It means that those with the seasonal allergy could begin to see hayfever symptoms triggered in the coming weeks if not already.

Meanwhile, scientists have warned that climate change is making is making hay fever misery worse.

Lead author Dr William Anderegg, of the University of Utah in the US, warned: "The strong link between warmer weather and pollen seasons provides a crystal clear example of how climate change is already affecting peoples' health." The study found pollen seasons today start around 20 days earlier than in 1990. Warming is causing the plants' internal timing, known as its 'phenology', to start producing pollen earlier in the year. More pollen hanging around for a longer season makes those affects worse. Greenhouse experiments have shown increases in temperature and atmospheric CO2 - hallmarks of human-caused

36 | PHARMACYNEWSIRELAND.COM

climate change - can cause more pollen production. Tests have also suggested worsening of pollen seasons in some plant locations are due to rising temperatures. The study published in Proceedings of the National Academy of Sciences is the first to confirm it across a continent. Dr Anderegg said, "A number of smaller-scale studies - usually in greenhouse settings on small plants - had indicated strong links between temperature and pollen. "This study reveals that connection at continental scales and explicitly links pollen trends to human-caused climate change."

WHAT IS HAYFEVER? Allergic rhinitis is inflammation of the nasal passages caused by an allergen, such as pollen, dust, mould or skin flakes from certain animals. Hay fever is a type of allergic rhinitis caused by pollen or spores. Hay fever affects the nose, sinuses, throat and eyes. Hay fever usually occurs during the spring and summer months. Exactly when it occurs depends on which pollens the person is allergic



to. From May to July grass and flowers are in pollen, so this is the most common time for hay fever. Most common type of allergic rhinitis is Hay fever so I will refer to Hay fever commonly in this article. Trees, grass and plants release pollen as part of their reproductive process. Mould and fungi also release tiny reproductive particles, called spores which also cause allergies. People with hay fever can experience symptoms at various times of the year, depending on which pollens or spores they are allergic to. Grass is the commonest allergen implicated with symptoms of hayfever. Hay fever is a common condition that affects around 20% of the population. Hay fever is more likely if there is a family history of allergies, particularly asthma or eczema. It is estimated that up to 50% of asthmatics and up to 30% of eczema sufferers also have allergic rhinitis. Hay fever usually begins in the early teens and peaks when a person is in their twenties.

RECOGNISING THE SYMPTOMS This is an area that pharmacists are well placed to identify. Self-reporting of allergy is common, with some patients already having an allergy diagnosis. It is important for pharmacists to consider whether management in the pharmacy is appropriate, to acknowledge expertise limitations and know when to direct a patient to their GP. Patients who may require specialist management include those without a definitive diagnosis or those from specific patient groups with specialised treatment

pathways, for example pregnant women. Patients with a suspected food allergy should always be advised to see the GP for an allergy-focused clinical history. Symptom recognition in food allergy is an important aspect of patient education, so the patient knows when to use an adrenaline auto-injector. This is as important as knowing how to use it. Symptoms depend on which part of the body is affected. For example, hay fever (also known as seasonal allergic rhinitis, because it is mainly triggered by pollen) affects the eyes and nose, causing sneezing, a runny nose, watery, itchy eyes, irritated and itchy throat and, sometimes, a stuffy, blocked nose. Hay fever Symptom Summary • Sneezing • Blocked and runny nose • Sinus congestion with headaches, especially along the forehead • Itchy, red and watery eyes • Puffy eyes and lower eyelids • Cough and occasional wheeze • Ears popping with occasional hearing impairment • Diminished senses of taste and smell (severe hay-fever sufferers) • Itch along roof of mouth and back of throat when eating certain foods • Feeling of intense lethargy

Pollen could increase Covid susceptibility A study released last month suggests that the presence of pollen can make a person more susceptible to the Covid-19 virus. The report looked at the link between the powdery substance produced by plants and how it exacerbated the novel coronavirus. According to the study, pollen allows the Covid-19 virus to gain a foothold when it suppresses the immune system’s response to the virus. One of the study’s authors explained that researchers wanted to see how the number of new infections changed with the rise and fall of pollen levels in 31 countries around the world. Lewis Ziska, associate professor of environmental health sciences at Columbia University, said, “We found that, on average, about 44% of the variability in Covid-19 case rates was related to pollen exposure, often in synergy with humidity and temperature.” The study, published in the Proceedings of the National Academy of Sciences, looked at not only pollen levels, but such metrics as population density, temperature, lockdown restrictions and the amount of humidity on a certain day. What the researchers found was that when pollen in an area spiked, infections spiked as well. The pollen seems to rile the immune system. “When we inhale pollen, they end up on our nasal mucosa and here, they diminish the expression of genes that are important for the defense against airborne viruses,” Stefanie Gilles, one of the study’s authors and chair of environmental medicine at the Technical University of Munich in Germany, said in a news conference. The reason pollen seems to be linked to an increase in Covid-19 infections, researchers said, is that pollen may cause the body to drop its defenses against the airborne virus that causes the infection. “If you’re in a crowded room and other people are there that are asymptomatic, and you’ve just been breathing in pollen all day long, chances are that you’re going to be more susceptible to the virus,” Ziska said. “Having a mask is obviously really critical in that regard.”

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120 mg Film-coated tablets Fexofenadine hydrochloride

T H E O N LY

✓ FA S T - AC T I N G ✓ LO N G - L A S T I N G * ✓ N O N - D ROWS Y H AY F E V E R R E L I E F

LIV E YOU R LI F E , N OT YOU R ALLE RG I E S *In clinical trials vs placebo Telfast Allergy 120mg film-coated tablets Product Information Presentations: Telfast Allergy (fexofenadine hydrochloride) 120mg film-coated tablets, containing equivalent to 112mg of fexofenadine. Indications: Telfast Allergy is indicated in adults and children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis. Dosage and Administration: Adults and Children ≥ 12 years: The recommended dose is one tablet (120mg) once daily taken before a meal. Children (<12 years old): The efficacy and safety has not been studied. Elderly; Renally or Hepatically impaired patients: studies indicate that dose adjustment is not necessary but Telfast Allergy should be administered with care in these patients. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions and Warnings: Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines, have been associated with the adverse reactions, tachycardia and palpitations. Interactions: Coadministration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to increase the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval or an increase in adverse reactions compared to the medicinal products given singly. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids. Pregnancy: Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary. Breast-feeding: Fexofenadine hydrochloride is not recommended for mothers breast-feeding their babies. Adverse Reactions: The following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo. Common (≥1/100 and<1/10): Headache, drowsiness, dizziness, nausea. Uncommon (≥1/1,000 and <1/100): Fatigue. The following undesirable effects have been reported in post-marketing surveillance. Frequency not known: Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis, insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria) tachycardia, palpitations, diarrhoea, rash, urticaria, pruritus. Legal Category: P. Marketing Authorisation Number: PA540/170/1. Marketing Authorisation Holder: Sanofiaventis Ireland Ltd., T/A SANOFI Citywest Business Campus Dublin 24 Ireland. Further information is available from: Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com. Date of Preparation: September 2020 Adverse events should be reported. Reporting forms and information can be found at: www.hpra.ie E-mail: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland - Tel: 01 403 5600. Alternatively, send via E-mail to IEPharmacovigilance@sanofi.com MAT-IE-2100473 (v1.0) March 2021


Product Information: Piriton 4mg Tablets (Chlorphenamine maleate). Indications: Treatment of acute allergic reactions. Dosage and method of administration: Minimum dosing interval 4 hours. Adults and children 12 years and over: 1 tablet every 4-6 hours (maximum of 6 tablets in 24 hours). The elderly: 1 tablet every 4-6 hours (maximum of 3 tablets in 24 hours). Children 6-12 years: 0.1mg/kg or ½ a tablet every 4-6 hours (maximum of 6 half tablets in 24 hours). Children under 6 years: Not recommended. Contraindications: Hypersensitivity to ingredients. Pre-coma states. Patients who have been on MAOI therapy within previous 14 days. Precautions: May act as cerebral stimulant in children and adults, with children and elderly more likely to experience paradoxical excitation. Use with caution in patients with severe renal or hepatic impairment, epilepsy, severe hypertension and cardiovascular disease, raised intra-ocular pressure, prostatic hypertrophy, bronchitis, thyrotoxicosis, bronchiectasis and bronchial asthma. May cause drowsiness. May seriously affect ability to drive and operate machinery. Avoid alcohol or concurrent use with sedative drugs. Avoid in elderly with confusion. Should not be used with other anti-histamine containing products. Contains lactose. Keep out of reach and sight of children. Side effects: Sedation, somnolence, disturbance in attention, abnormal coordination, dizziness, headache, blurred vision, nausea, dry mouth, vomiting, abdominal pain, diarrhea, dyspepsia, fatigue, chest tightness, blood dyscrasias, allergic reactions including anaphylaxis. Neurological anticholinergic effects, particularly in the young and elderly. Overdose: Symptoms of overdose likely to be similar to side effects listed and requires medical attention. Legal category: Pharmacy Only. Product Licence Number: PA 0678/080/001. MAH: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. Full product information is available in the SPC. Additional information is available upon request. Text prepared: April 2020. Contains Chlorphenamine maleate. Always read the label/leaflet. Trade marks are owned by or licensed to the GSK group of companies. PM-IE-PIRI-21-00004


People’s experience of hay fever symptoms can vary from year to year, which can make it difficult for customers to know which products to use, even those who have experienced symptoms before. Pharmacies should offer a varied range of allergy remedies in multiple formats. First-time sufferers often have to use trial and error to find a remedy that works well for them, so having multiple options available allows customers to continue returning to trial a variety of products. Advice relating to the different remedies from the pharmacist will also help the customer determine the best treatment for them. The hay fever season can be a frustrating time for sufferers, so quality advice from a trusted professional will be greatly appreciated.

AVAILABLE TREATMENTS The choice for treating allergic rhinitis can be confusing. Pharmacists are well placed to recommend a product that is matched to symptoms and their severity. It is beneficial to start treatment before symptoms begin. Eye symptoms are common in allergic rhinitis, with patients reporting red, watery and itchy eyes in addition to nasal symptoms. If this is the case, eye drops may be required. Antihistamines are the first line of defence for many allergic conditions.When helping patients choose an antihistamine, it is important to be aware of the sedative effect of first-generation drugs, as well as the short duration of action. The benefit of second-generation antihistamines is the

rapid onset, which is good for compliance, as is the daily dosing and the fact that they are non-sedating. On occasion, patients may require high doses of antihistamines to manage allergic or potentially non-allergic symptoms – eg in chronic spontaneous urticaria. Although these doses should be prescribed, it is important to provide reassurance that they are safe and within national guidelines.

The majority of sufferers find that the allergy can severely disrupt their lives, with up to 94% of hay fever patients reporting that their symptoms have an impact on their day-to-day work.

Top Tips for Sufferers • Keep doors and windows closed at home and when driving;

ALLERGIES AND ASTHMA People who have allergies often also have asthma. And people with asthma often have allergies. While the two may not seem related, studies show about twothirds or more of those with asthma also have an allergy.

• Apply a little Vaseline inside the nose to trap pollen and stop it being inhaled;

What many people don’t realise is that the same things that triggers their seasonal hay fever symptoms – things like pollen, dust mites, mould and pet dander – can also cause asthma symptoms.

• Wear sunglasses, preferably wraparound glasses which prevent pollen entering the eyes;

Allergic asthma – where allergies are triggers for asthma symptoms – is the most common type of asthma. Researchers have long known that the frequency of children with allergies who also have asthma can be as high as 80%. Recent research has shown that about 75% of adults aged 20-40 with asthma, and 65% of those with asthma aged 55 years and older, have at least one allergy.

• Don’t mow the grass and avoid working in the garden;

Local research has shown that up to 80% of Ireland’s 470,000 asthma sufferers also have hay fever. There are more than 30 types of pollen and 20 types of spores which can trigger hay fever.

• Don’t dry clothes outside if possible; and • Wash your hair, hands and face when you come back indoors and change your clothes to get rid of any pollen.

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Brought to Tears – Dry Eye in Pharmacy Written by David Kent, Consultant Eye Surgeon & Retina Specialist, The Vision Clinic, Kilkenny

Mr David Kent is a Consultant Ophthalmic Surgeon & Retinal Specialist. After qualifying in Galway in 1990 he undertook his eye training in the UK and USA. This included time in Great Ormond Street Children’s Hospital and Kings College Hospital in London and St Paul’s Eye Unit in Liverpool. His subspecialty training in medical and surgical retina was undertaken in the Wilmer Eye Institute, Johns Hopkins Hospital, Baltimore, USA and the Royal Liverpool University Hospital, UK. He completed a Wellcome Trust Vision Research Fellowship and post-graduate thesis in retinal detachment at the University of Liverpool. He returned to Ireland in 2003 and in addition to his commitment to his patients, he remains active in research with an affiliation with the University of Liverpool, UK. He is also Adjunct Professor, School of Biomolecular and Biomedical Science, UCD, Dublin.

INTRODUCTION

D

ry eye disease (DED) is one of the most prevalent eye conditions seen throughout the world. According to the Tear Film & Ocular Surface Society (TFOS) “dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis

of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.” The lubricating system of the surface of the eye consists of the moving eyelids, the meibomian glands of the eyelid margin, the lacrimal and accessory lacrimal glands

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and of course the tear film itself. The tear film consists of 3 layers: a mucin layer that covers the ocular surface; an aqueous layer that, in addition to its lubricating function, also provides nutrients, antimicrobial proteins and the appropriate osmolarity; and a lipid layer to prevent loss of the aqueous layer through evaporation. DED can be broadly divided into two predominant, but often overlapping


For more information please contact your Pemberton Rep or For more information pleaseCustomer Service on 01-4632424 contact your Pemberton Rep or Customer Service on 01-4632424


categories, of evaporative dry eye (EDE) and aqueous deficient dry eye (ADDE), with EDE being the more prevalent. ADDE refers to conditions effecting lacrimal gland function while EDE is related to disorders of the lid margin such as meibomian gland disease (MGD) and ocular surface abnormalities such as mucin deficiency and contact lens-related problems. If the pathology causing dry eye arises within the lacrimal gland it is referred to as Sjogren’s syndrome, an autoimmune condition that can be primary, or secondary to other immune system disorders such as rheumatoid arthritis. EDE is caused by a chronic inflammatory condition of the eyelid margin referred to as blepharitis. Again, blepharitis can be further subdivided based on which part (anterior or posterior) of the eyelid is preferentially affected. In my clinic at least, most sufferers usually display a combination of both anterior and posterior blepharitis. For the readers of the Irish Pharmacy News the precise definition of DED is not important, nor indeed whether the primary pathology is arising in the lacrimal gland or elsewhere but the foregoing does gives you a fair idea of the complexity of this incredibly common condition and the challenges faced by the eye research community in developing meaningful therapies that address its complex pathogenesis. Despite significant improvements in our understanding of its pathobiology in the last number of years, the development of genuinely ground-breaking therapies remains stubbornly elusive.

RISK FACTORS There are multiple risk factors for DED, but most commonly, in Ireland at least, they tend to be female sex, increasing age, contact lens wear, computer use and low humidity (central heating, car heaters etc). Eye surgery, such as recent cataract surgery or laser refractive surgery, is also a risk factor for DED or can cause an exacerbation in preexisting disease. Medications most likely to cause dry eye symptoms include antihistamines, antidepressants, anxiolytics, isotretinoin and hormone replacement therapy. In my experience drug-induced dry eye is unusual. However, medications well recognised as exacerbating dry eye symptoms are of course preservativecontaining eye drops especially when used life-long, such as in glaucoma, or when used for prolonged periods, such as, and paradoxically as it sounds, preservative-containing ocular lubricants. Systemic conditions such as diabetes and thyroid disease are also known to be associated with DED but again in my experience this is unusual unless it is a known case of thyroid eye disease. Diabetes can of course cause a neuropathy of the cornea and this can lead

to a secondary dry eye but symptomatic disease is uncommon. Perhaps the commonest systemic condition that I see as been associated with DED is acne rosacea. Finally, hormonal fluctuation can be associated with DED such as may occur around the menopause, in pregnancy and with oral contraceptive drugs.

SYMPTOMS AND SIGNS Despite the bio-molecular complexity of dry eye, as a profession, you will be very familiar with the classical and stereotypical dry eye sufferer that may present to you. Symptoms include pain, redness, irritation, blurred vision, light sensitivity, itching and foreign body sensation and in addition to these ocular surface-related problems, there can be considerable psychological effects due to interference with both lifestyle and work productivity. Indeed, the societal and economic burden of such a prevalent condition is considerable. Even without sophisticated examination equipment, the eyes of a dry eye sufferer usually have a typical appearance. It is almost always bilateral and the eyes appear tired with mild to moderate degrees of redness with the lid margins often being quite red. The eyelashes can be crusty, stuck together or even scarce if they have fallen out. Swelling of the eyelids is almost never a feature in my experience and this helps to distinguish it from infective (typically viral) conjunctivitis.

TREATMENT Treatment of DED generally depends on the severity of symptoms but the ultimate aim is to restore homeostasis of both the ocular surface and tear film. Though there appears to be a myriad of products available to treat dry eye, clinically it can be one of the most frustrating ocular conditions of all to treat. This frustration is mainly due to the fact that what is effective for

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one sufferer may be totally ineffective or only partially effective for the next. That been said most practitioners employ a stepladder approach to therapy, starting with the simple things and moving up the rungs as DED becomes more challenging. Even before considering drug intervention, several simple, practical and effective non-pharmaceutical interventions can be recommended. The following is generally representative of my approach to the management of DED and what I have found most effective over the past number of years.

1. Modify your living/working environment and risk factors As the ocular surface is the most exposed mucosal surface of the body, modify your environment to avoid direct triggers, such as dry heat, especially when fan-assisted such as car heaters or central heating. Air conditioning can also trigger symptoms in larger indoor workspaces etc. Exposure to such adverse ambient conditions that promotes low humidity and/or increased/ decreased air temperature and/or air movement, can lead to increased tear instability and evaporation.


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2. Management of blepharitis In the presence of blepharitis appropriate lid hygiene is important and can reduce the lipid by-products and lipolytic bacteria that can be associated with this lid condtion. However, achieving a reduction in the bacterial load through the prescribing of topical antibiotic drops or ointment alone is not commonly recommended, especially over the longer term. Lid scrubs using a mild dilution of baby shampoo applied with a swab or cotton bud have been the most widely accepted therapy over the years. Alternatively, there are now a wide variety of proprietary OTC lid cleansing products available, which utilise a diversity of delivery mechanisms, including scrubs, foams, solutions, and wipes. In addition to lid scrubs, hot compresses using a cottonwool ball dipped in hot water are, in my experience, also effective. Whether heat works by melting the offending secretions on the lid margins and eye lashes, or by opening up the meibomian gland orifices or through improved blood flow to lid margins, or through a combination of these mechanisms is unknown. All these strategies should improve symptoms if performed diligently and regularly, especially during episodic exacerbations of symptoms. Despite the proven efficacy of warm compresses in many clinical studies, compliance is often poor due to practical issues such as time and the manual dexterity requirements and even the challenge of maintaining the compress at an effective temperature for the necessary period of time. In a suitably motivated patient I typically recommend the lid hygiene or compresses or a combination of both for 5-10 minutes in the morning and evening.

3. Ocular surface lubricants (‘artificial tears’) In terms of tear replacement, there are a wide variety of options available and while they may vary by osmolarity, viscosity and pH, they are largely similar in their major components. The most abundant component in artificial tears is of course the aqueous base but to enhance lubrication and prolong the retention time on the ocular surface, a variety of viscosity enhancing agents, such as polyacrylic acid and hyaluronic acid are frequently incorporated. I instruct my patients to instil their lubricants as frequently as is necessary to relieve symptoms, stressing that there are no bioactive compounds that may cause toxicity. I will also recommend lubricating ointments last thing at night in people who report dry eye symptoms immediately on waking in the morning. Physiologically, we all produce less tears at night so first thing in the morning can

be particularly difficult for many dry eye sufferers. Finally, I always recommend preservative free lubricants.

a longer-term anti-inflammatory strategy for dry eye, especially in the setting of Sjogren’s disease.

4. Anti-inflammatory approaches

Acne rosacea is a chronic inflammatory skin disease affecting the face, that occurs mainly in adults, usually in the third and fourth decades. It is strongly correlated with posterior blepharitis (meibomian gland disease) and can therefore contribute to symptoms of DED. In such situations I may prescribe a Tetracycline analogue (minocycline, doxycycline) for a minimum period of 3 months. As these agents have both broad-spectrum anti-bacterial and anti-inflammatory properties, it is hypothesized they decrease lipase, lipid by-products and lipolytic bacteria on the lid margins as well as decreasing specific mediators of inflammation such as matrix metalloproteinases (MMPs) and tumour necrosis factor (TNF)-alpha. In more recent years, as I have become more aware of the potential detrimental action of these antibiotics on the gut microbiota, I have tended to avoid their use.

In addition to the foregoing and where symptoms are typically moderate to severe, I will usually prescribe a course of topical steroids for 3-4 weeks. Although steroids have a rapid onset of action and can be efficacious within hours of their instillation, in my opinion a 3–4-week course is necessary because of the chronic nature of DED in many people. I believe a shorter course of steroid can lead to rebound of symptoms and having to ‘start again’. Of course, as practitioners we are always concerned about the whole issue of steroids and a steroid-induced rise in intraocular pressure or activating or reactivating herpetic eye disease so the decision to administer steroids must be weighed up accordingly. Again, in severe/protracted DED, I would always prescribe preservative free steroids. In so-called steroid reponders, I have had some success with topical NSAIDs as an alternative. Several agents are available and if one NSAID does not work it is often worthwhile to try the alternatives. I also have had some success with specific antihistamines especially when ocular itch is a major symptom or in those who suffer exacerbations of their dry eye symptoms during times of seasonal allergy.

5. Punctum occlusion The option of temporary or permanent occlusion of one or both puncta to retain tears on the ocular surface by blocking their drainage is also a good option to consider in DED. I have a low threshold for considering occlusion. It is simple to do and can be highly effective such that if a patient remains symptomatic after effective management of their blepharitis and has been compliant with their eyedrops/ointments, I will then proceed with occlusion.

6. Other therapies The role of omega-3 polyunsaturated fatty acids (PUFAs) supplementation for treating DED is not yet completely understood. Although a sizeable number of clinical trials have been conducted, most have been of short duration and show contrasting findings. However, based on my anecdotal experience, I do recommend them when the approaches outlined above fail. Their potential multiple mechanisms of action at a cellular level make them a useful therapy to keep in reserve for DED. Because ocular surface inflammation is pivotal, not only in the development of DED, but also as a downstream propagator, together with ongoing concerns about long-term use of topical steroids, cyclosporine, a regulator of T cell activity, is also available in topical form, as

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Finally, my ultimate recommendation when all else fails are tears made from a patient’s own serum (HSE Serum Eye Drop Programme). Autologous serum is similar to human tears in terms of pH, growth factor content and other repair-promoting factors and several studies have demonstrated their efficacy in enhancing repair of the cells lining the ocular surface. In fact, I will content that if a patient fails to get relief for their dry eyes from serum tears, it is likely that the patient may be suffering from an idiopathic chronic pain syndrome necessitating their referral to a pain specialist. In summary, DED is an extremely prevalent condition causing significant ocular morbidity. There are multiple risk factors and identifying and modifying them is the first step to successful therapeutic intervention. I employ a stepladder approach to therapy that starts with the effective management of lid margin disease, if present. This is usually combined with ocular lubricants on a PRN basis as well as a course of topical steroids if indicated. If longer term use of steroids is indicated, regular monitoring of intraocular pressure is indicated. Other therapeutic options include topical NSAIDs, anti-histamines and cyclosporine. If all else fails my final ‘go to’ option is autologous serum tears which can be used in combination with the above.


Topic Team Training – Sleep Disorders A community pharmacy environment that fosters teamwork ensures high levels of consumer satisfaction. This series of articles is designed for you to use as a guide to assist your team in focusing on meeting ongoing CPD targets and to identify any training needs in order to keep the knowledge and skills of you and your team up to date.

The below information, considerations and checklist provide support to enable you to run a team training session and identify opportunities for learning within the topic of Sleep Disorders. Types of sleep disorders Historically there have been three major classification systems for sleep disorders. These are (1) International Classification of Sleep Disorders (ICSD), (2) Diagnostic and Statistical Manual of Mental Disorders (DMS) and (3) American Psychiatric Association and the International Classification of Diseases (ICD). In total there are over 80 sleep disorders with insomnia being the most common. Acute (short term/transient) insomnia is a common complaint, and a stressor can usually be identified. The insomnia

complaint usually subsides once the stressor is eliminated. Prevalence of acute insomnia is generally between 30-50 % of the population (pre COVID-19). Chronic Insomnia, according to the ‘European guidelines for the diagnosis and treatment of Insomnia,’ is defined as one or more of the following: (1) Difficulty initiating sleep (2) Difficulty maintaining sleep (3) Early awakenings (4) Resistance to going to bed. The reported sleep/wake complaints occur despite adequate opportunity for sleep. The sleep disturbance and daytime consequences must occur at least 3 times per week and must have been present for at least 3 months. The sleep/ wake difficulty is not explained by another sleep disorder. Women are twice as likely to suffer from insomnia, individuals with a

Consider:  Do I know which medicines can cause insomnia and do we check which medicines customers are taking if they describe symptoms?  Are we confident about raising issues of sleep disorders with customers?  Do we look out for cases of chronic insomnia?  Can we provide good advice?  Do any of us suffer from sleep disorders in the pharmacy team? Are some individuals more affected than others? If so, why?

history of shift work, older adults, post-menopausal women, those with a medical or psychiatric condition and even those from a lower socio-economic background are at greater risk. In recent times, employment stresses are playing an increased role in the development of an insomnia disorder. Bereavement, relationship issues, or any kind of life changes have the potential to cause an insomnia disorder. Since the start of COVID-19 pandemic, worries and anxiety around health have played a huge role in the increase of insomnia. Management of insomnia can differ depending on the disorder being acute or chronic. The pharmacist can play a vital role in the management

Key Points:  Ensure the pharmacy team knows to be sensitive in dealing with customers who may feel vulnerable as a result of insomnia • The team knows which groups of customers are likely to be at risk of insomnia and other sleep disorders • My counter assistants can meet the points in this training checklist.

of acute insomnia and when to advise the patient to see a GP as the disorder becomes chronic or if short-term treatments are unsuccessful. Further Assistance: The Sleep Disorder Support Foundation: www.sdsf.ie

Actions: Ensure support staff understand the following key points:  The common causes of insomnia, including lifestyle issues, medication and conditions that can cause sleep issues  How to spot sleep disorders and insomnia in both colleagues and customers to get them the help they need  The benefits and limitations of OTC medicines  The importance of good sleep hygiene for everyone  Lifestyle issues that may cause sleep disorders, and tips on improving lifestyle  The importance of regular food intake and sufficient exercise  When to refer customers to the pharmacist.

PHARMACYNEWSIRELAND.COM | 47


48

News

FEMPI once again on the Agenda The issue around Financial Emergency Measures in the Public Interest cuts made to pharmacies was on the agenda once again as Deputy Cian O’Callaghan recently raised the issue in a Dáil Éireann Debate. The Deputy asked Minister for Health Stephen Donnelly when the cuts would be reversed. Responding, the Minister stated, “I wish to fully acknowledge that community pharmacy has played a pivotal role in responding to the health needs of the public during the Covid-19 crisis. It is recognised that community pharmacists have ensured the continued availability of a professional, accessible service for the public and have successfully managed to alleviate the worries and concerns of the population around continuity of

medicine supply in the face of great uncertainty. “The regulations to which the Deputy refers, were made under section 9 of the FEMPI Act 2009 and these were set to expire at the end of 2019. It was therefore necessary for my predecessor to enact new legislation under the Public Service Pay and Pensions Act 2017, in order to maintain a statutory basis for contractor payments and to prescribe the fees payable from that date. “The previous Government gave a commitment to commence a strategic review of the role

of community pharmacists and to engage with the Irish Pharmaceutical Union to develop revised contractual terms. It is my intention to honour that commitment as the existing GMS pharmacy contract is substantially outdated. It has not kept pace with developments that have taken place over the course of recent years including the increasing emphasis on maximising the proportion of people’s healthcare needs met in primary care, interdisciplinary collaboration and the skillset that pharmacists have by virtue of their education and training.

“The comprehensive review of the pharmacy contract will address the role to be played by community pharmacy in the context of Sláintecare. It will consider all aspects of pharmacy service provision including delivery of a multi-disciplinary model of service delivery for patients, ensuring clarity of roles and achieving optimum value for money. However, any publicly funded pharmacy service expansion should address unmet public healthcare needs, improve access to existing public health services or provide better value for money or patient outcomes.”

Jerusalema raises Smiles and Funds The Jerusalema Challenge that so many community pharmacies across Ireland took part in, is also helping to raise much needed funds for local charitable initiatives. totalhealth Pharmacies also took part in the challenge, and not only did it make everyone smile it also helped raise vital funds for the Mayo Roscommon Hospice Foundation. Huge congratulations to Ollie and his team at McGuinness totalhealth Pharmacy, Roscommon Town on their fabulous donation of ¤1000.00 to such a worthy cause! This is the second donation to the Mayo Roscommon Hospice that came via the Jerusalema Challenge as the wonderful team at Joanne Hynes totalhealth Pharmacy have also donated ¤1000.00 to the cause.

Impact of Covid-19 on Pharmacy Practice University College Cork’s Dr Aoife Fleming recently presented research at the SPHeRE 2021 conference which took place in February. The research was entitled, “A mixed methods study investigating the impact of Covid-19 on community pharmacy practice and pharmacist wellbeing.” The research team involved in this project are School of Pharmacy researchers Dr Kieran Dalton, Dr Aoife Fleming and Dr Suzanne McCarthy.

Dr Aoife Fleming, Lecturer, Clinical Pharmacy, University College Cork

Pharmacy student, Caoimhe Murphy, was supported by the College of Medicine and Health SURE award 2020 to work on this project during summer 2020 and Pharmacy student, Ciara Kenny, gained research experience on this project during her APPEL Fourth year placement. The presentation outlined the preliminary findings of a qualitative interview study and national survey of Irish Community Pharmacists during the initial months of the Covid-19 pandemic. Caoimhe Murphy commented, “I was delighted to have had the

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opportunity this past summer to work alongside Dr Aoife Fleming, Dr Kieran Dalton and Dr Suzanne McCarthy in researching the impact of the Covid-19 pandemic on Irish pharmacists. I was also lucky enough to receive the SURE summer research support from the school of pharmacy, which helped to support me financially while I undertook this important research. My input in this research project was comprised of various roles including research design and analysis. I thoroughly enjoyed this research and was delighted to help highlight the essential role that pharmacists played in the pandemic. Despite taking part in this placement remotely, I always felt supported by the team. This summer project was an excellent opportunity for me to further explore my interest in research and I am very happy that I took part in it.” Ciara Kenny added, “I was very

happy to work on this study, as part of my APPEL fourth year experiential learning placement with UCC School of Pharmacy. Having worked part-time in community pharmacy throughout the pandemic, I can appreciate the huge contribution made by Irish pharmacists over the last twelve months. It was a privilege to play some small role in highlighting the experiences and challenges faced by community pharmacists in the early months of the Covid-19 pandemic. Through taking part in this research, I have developed a number of new skills such as quantitative analysis of survey results and academic writing, skills which will undoubtedly stand to me in my studies and future career. I would like to thank Dr Fleming, Dr McCarthy, Ms Caoimhe Murphy and in particular my placement preceptor, Dr Kieran Dalton, for giving me the opportunity to get involved with this study and for their support and guidance."


Stroke

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Cardiovascular Disease Prevention and Rehabilitation Croí - delivering the right care, at the right time - ‘virtually’ during COVID-19 Written by Irene Gibson, HRB SPHeRE Scholar, NUI Galway - Director, Programmes & Innovation, National Institute for Prevention & Cardiovascular Health Introduction We are all aware that as a consequence of COVID-19 there has been significant disruptions to essential cardiology services with resultant negative implications for patients. One area seriously impacted by the pandemic has been hospital based cardiac rehabilitation. Reported attendance drops of over 70% due to issues such as cardiac rehab programme closure, staff re-deployment etc is very concerning given that cardiac rehabilitation has been shown to reduce hospital readmissions by up to 25% and cardiovascular mortality by as much as 58%. What is Croí MySláinte? In response to this urgent situation, Croí, the heart & stroke charity in Galway in collaboration with the National Institute for Prevention & Cardiovascular Health, developed a virtual, web-based, CVD prevention and rehabilitation programme, called MySláinte. Supported by Sláintecare Integration funding, this 12 week programme offers a new and alternative way of delivering preventive care making it accessible for people to access from the comfort and safety of their home. Delivered by a specialist interdisciplinary team (Cardiovascular Nurse Prescriber, Physiotherapist, Dietitian) with sessional Psychology and Cardiologist support the programme addresses the medical and lifestyle drivers of CVD, whilst providing important psychosocial support at a time of increased anxiety and social isolation for patients. The programme was co-designed with input from key stakeholders including patients, health care professionals (including cardiac rehabilitation staff) and e-learning technologists. It has been modelled on the evidence based MyAction programme and aligns to best practice International guidelines for remote delivery of healthcare to CVD patients. The core components of Croí MySláinte include lifestyle modification (smoking cessation, healthy food choices, and physical activity), medical risk factor management (blood pressure, lipids, and glucose) and the prescription of cardio-protective

medication where appropriate. The programme is delivered using a web based platform (see figure 1) which hosts a wide range of interactive educational resources, including bespoke pre-recorded videos and links to weekly live zoom sessions. Croí MySláinte adopts an integrated care approach to care with referrals from multiple sources including cardiac rehabilitation units, hospital cardiology departments and general practice. Once a patient agrees to participate in the programme they are invited to attend an individual virtual consultation with the health team (nurse, dietitian and physiotherapist). Following this initial assessment they receive access to the online platform and attend a group-based, 2 hour live session once a week. This includes an exercise component, goal setting and an interactive workshop. The programme places a strong emphasis on selfmanagement by utilising specific behavioural change techniques and self-monitoring tools. For example, all participants are provided with a blood pressure monitor for home measurement, a fitbit to track their steps, heart rate and exercise progression, food and exercise diaries and a workbook to support goal setting and overall tracking of progress. The objective is to equip individuals with the knowledge skills and confidence to make changes to their lifestyle in a realistic way that can be sustained long-term. Weekly virtual interdisciplinary team meetings are held to review lifestyle, risk factor and therapeutic goals and where necessary, the nurse prescriber facilitates medication optimisation working in collaboration with the GP and Cardiologist. Outcomes Since Croí MySláinte commenced in September 2020, a total of 105 patients have been referred to-date with an uptake rate of 73% (n=77). The main barriers to participation include poor digital literacy skills, inadequate IT support (equipment and broadband), other health issues and family commitments. In just four months, three 12 week programmes have been delivered with a completion rate of 83%

(n=64) being observed. The age range of participants is between 35 and 84 years with an average age of 63 years. The programme outcomes are based on the primary endpoints for lifestyle, risk factor and therapeutic goals as recommended by the European Society of Cardiology and these are currently being evaluated. Through qualitative focus groups, findings to date reveal that patients feel the programme has acted as an important catalyst for improving their health behaviour. Knowledge acquired on the programme, together with the actions required to self-manage (monitor blood pressure, track fitness and weight) have empowered participants to better manage their health. Patients have reported improvements in their confidence and relationship with their GP as they feel they are now “more in the driving seat”. The convenience and timing of the programme was highly valued as many patients reported otherwise waiting between 3 -12 months for Cardiac Rehab. The peer support component was also highly valued “I didn't think it would be possible for me to do a programme like this as I am caring for my wife with Alzheimer's, but online access is a lifesaver, I can connect with people and not feel so alone”. Key learnings The Croí MySláinte Programme is the first programme of its kind in Ireland delivering comprehensive, interdisciplinary CVD prevention and rehabilitation ‘virtually’. While the clinical outcomes have yet to be fully evaluated, the virtual delivery model signals new opportunities and an alternative option to traditional CR or as an adjunct to existing programmes. This programme has proven that: • It reduces traditional attendance barriers such as travel, work, childcare or carer responsibilities. • Age is not a barrier to accessing an online programme. • Nurse prescribing ensures efficient medical management - especially important during COVID where there is limited access to General Practice and specialist clinics.

Irene Gibson, HRB SPHeRE Scholar, NUI Galway - Director, Programmes & Innovation, National Institute for Prevention & Cardiovascular Health

• Patients can become active participants in their own care. • Administration support is vitally important to participants as they become familiar with the technology. • The co-design approach to programme development was essential and invaluable to implementation. • Standard operating procedures such as; inclusion and exclusion criteria, key performance indicators, policies and procedures (data protection and health and safety) etc are essential. The Croí Heart and Stroke Centre was awarded European Association of Preventive Cardiology accreditation in 2020 in recognition of its high quality prevention and management programmes. It is the first and only centre in Ireland to receive this accreditation. The Croí MySláinte programme is funded by the Government of Ireland’s Sláintecare Integration Fund 2019, under Grant Agreement Number 121 to support the delivery of services which focus on prevention, community care and integration of care across all health and social care settings.

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CPD: Pain Continuing Professional Development

CPD 60 Second Summary The 2020 pain definition is: “An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.” Pain signals are sent from nociceptors to the cerebral cortex via the spinal cord. The motor cortex then elicits a physical response if necessary. Specialised receptors on primary afferent nerves signal the sensations of pressure (compression), inflammation (prostaglandins, nerve growth factors, cytokines, interleukins), and temperature, amongst others. Pain management is one of the most common reasons for people to seek advice in the community pharmacy with 47% of EU consumers having used an overthe-counter (OTC) analgesic once per week in the last month. “Acute pain” (pain lasting <12 weeks) results from inflammation and swelling, and can significantly impact functional ability and quality of life. Non-steroidal anti-inflammatory drugs work through mediation of prostaglandin and thromboxane A2 production through reversible inhibition of the enzyme cyclooxygenase (COX). Prostaglandins mediate many physiological functions including inflammatory and nociceptive processes; also maintaining the gastric mucosal barrier, regulating renal blood flow and endothelial tone. The mechanism of action of paracetamol was elusive for a long time. It appears to inhibit COX 1 and COX 2, although it does not inhibit COX in peripheral tissues. It is for this reason that paracetamol has no peripheral anti-inflammatory effects like traditional NSAIDs. Understanding the definition of, and mechanisms behind, pain can aid with pain assessment. When evidence-based recommendations of OTC analgesics are made while taking into consideration individual patient characteristics, this can make a significant positive impact on patient outcomes.

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AUTHOR: Donna Cosgrove PhD MPSI Donna graduated with a BSc in Pharmacy from the Royal College of Surgeons in Ireland. She then returned to university to complete a MSc in Neuropharmacology. This led to a PhD investigating the genetics of schizophrenia, followed by a postdoctoral research position in the same area. Currently Donna works as a pharmacist in Galway, and as a clinical writer.

1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice?

knowledge gap - will this article satisfy those needs - or will more reading be required?

2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.

4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result?Have I identified further learning needs?

3. PLAN - If I have identified a

5. WHAT NEXT - At this time you may like to record your learning for future use or assessment. Follow the

4 previous steps, log and record your findings. Published by IPN. Copies can be downloaded from www.irishpharmacytraining.ie Disclaimer: All material published is copyright, no part of this can be used in any other publication without permission of the publishers and author. Solpa-Extra has no editorial oversight of the CPD programmes included in these modules.

Community Pharmacy Management of Acute Pain Introduction In 2020, for the first time since 1979, the International Association for the Study of Pain (IASP) introduced a revised definition of pain, in the hope that this will lead to revised ways of assessing pain.1 Individuals experiencing pain, their caregivers, and healthcare professionals contributed to discussions on this. The 2020 pain definition is: “An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.” The highlighted portion here is a new addition to the definition. Six key points have been identified to further expand on this: • Pain is always a personal experience that is influenced to varying degrees by biological, psychological, and social factors. • Pain and nociception are different phenomena. Pain cannot be inferred solely from activity in sensory neurons. • Through their life experiences, individuals learn the concept of pain. • A person’s report of an experience as pain should be respected.

• Although pain usually serves an adaptive role, it may have adverse effects on function and social and psychological well-being. • Verbal description is only one of several behaviours to express pain; inability to communicate does not negate the possibility that a human or a non-human animal experiences pain. Pain Signalling Pain signals are sent from nociceptors to the cerebral cortex via the spinal cord. The motor cortex then elicits a physical response if necessary. Specialised receptors on primary afferent nerves signal the sensations of pressure (compression), inflammation (prostaglandins, nerve growth factors, cytokines, interleukins), and temperature, amongst others. In order for the receptor to elicit a peripheral signal, depolarisation must surpass the threshold for action potential generation.2 Acute pain is generated in response to something e.g. hot or sharp, but chronic pain can continue even after the original stimulus is no longer eliciting a response, or the initial injury has healed. This is due to a hypersensitivity to the presence of stimuli that do not normally cause a pain response.

There are several types of nerve fibres that carry information relevant to pain sensation: in general, A-δ and C-fibres are the major contributors to physiological nociception, with A-β fibres contributing in pathological states of central sensitisation (enhanced response to a lasting/repetitive stimulus of same intensity). Thinly myelinated A-δ nerve fibres propagate the sensation of sharp initial pain, mainly responding to mechanical stimuli or heat. Unmyelinated C-fibres can respond to multiple stimuli. They conduct impulses at a slow rate, giving rise to dull, longer-lasting pain. C-fibres are affected by both sensitisation and fatigue (reduced response to a lasting/ repetitive stimulus). There are broadly thought to be two brain systems involved in pain perception. The sensorydiscriminative system is thought to process the nociceptive input (intensity, localisation, quality).3 Separate brain regions in the cognitive-affective system are involved in the involved in the psychological aspects of pain, although the separation between the two systems is not clear cut. The descending pain pathway is activated in response to pain stimulus, which includes cortical regions and periaqueductal grey (PAG) in the brainstem.

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52

CPD: Pain

Pain is a highly subjective experience governed by multiple variables. In humans, pain perception is very complex and is influenced by social, psychological, and biological factors. Cognitive processes e.g. attention, anticipation, catastrophising, appraisal, and perceived control over pain have a substantial influence.3 Pain Management Pain management is one of the most common reasons for people to seek advice in the community pharmacy4 with 47% of EU consumers having used an overthe-counter (OTC) analgesic once per week in the last month.5 The characteristics of a good analgesic for OTC use are:

paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, complementary therapies, and herbal products, that medicine selection can be difficult.7 Even within these variations, different formulations are available: fast acting tablets, effervescent powders/tablets, liquids, and combination products. When a patient seeks pain relief, it is important to understand what outcome(s) the patient is seeking7, e.g. • Reduce pain intensity • Improve physical functioning • Aid return to work or school • Improve health-related quality of life.

Paracetamol

• Good pain relief to a high proportion of people taking the medicine,

Over-the-Counter Analgesics

• Fast onset of action, and

NSAIDs

• Long duration of action.

Non-steroidal anti-inflammatory drugs work through mediation of prostaglandin and thromboxane A2 production through reversible inhibition of the enzyme cyclooxygenase (COX). Prostaglandins mediate many physiological functions including inflammatory and nociceptive processes; also

“Acute pain” (pain lasting <12 weeks) results from inflammation and swelling, and can significantly impact functional ability and quality of life.6 Patients are presented with such a broad range of OTC analgesics, e.g.

maintaining the gastric mucosal barrier, regulating renal blood flow and endothelial tone.6 Ibuprofen is the first-line NSAID recommendation for a variety of pain, including lower back pain, period pain and toothache.7 Aspirin is also used for aches and pains; like headache, migraine, toothache and period pain. Ibuprofen is generally preferred however as it is better tolerated. NSAIDs should not be sold to patients with active gastrointestinal (GI) bleeding/ulcer; a history of hypersensitivity/severe allergic reaction, e.g. asthma, rhinitis, angioedema or urticaria; severe heart failure; or severe kidney or liver impairment. Aspirin is contraindicated in history of hypersensitivity to aspirin or any other NSAID.

The mechanism of action of paracetamol was elusive for a long time. It appears to inhibit COX 1 and COX 2, although it does not inhibit COX in peripheral tissues. It is for this reason that paracetamol has no peripheral anti-inflammatory effects like traditional NSAIDs.8 Paracetamol is a suitable first-line choice for most adults with mild-to-moderate CPD: Pain pain, based on the expert opinion Donna Cosgrove PhD of the Committee on the SafetyMPSI

Presenting condition

Evidence-based recommended analgesic

Lower back pain

NSAIDs; e.g. ibuprofen 400mg three times per day at the lowest possible dose for the shortest possible time. Do not offer paracetamol alone.

Tension-type headache

Aspirin (300mg three times per day), paracetamol or ibuprofen, considering patient preference and comorbidities.

Sprains and strains

Paracetamol (500mg to 1g four times per day, with a maximum 4g in 24 hours) or topical NSAID (e.g. ibuprofen or diclofenac gels) are recommended first-line. Oral NSAID (e.g. ibuprofen 400mg three times per day) 48 hours after the initial injury if needed.

Period pain

NSAID (e.g. ibuprofen) unless contraindicated. Paracetamol can be used if a NSAID is contraindicated or provides insufficient pain relief.

of Medicines Pain Management Working Group7, which includes members from the British Pain Society and the Medicines and Healthcare products Regulatory Agency (MHRA). The metabolism of paracetamol is significantly influenced by individual genetics, which has an impact on both toxicity and efficacy. Codeine Like paracetamol, the metabolism of codeine is subject to genetic influence. It is metabolised to morphine and morphine-6glucuronide in the liver. Reduction of pain perception and increased tolerance to pain is due to binding of these molecules to central opioid receptors. As codeine is a centrally acting drug, it also causes unwanted effects of drowsiness and respiratory depression. Peripheral receptor binding can cause nausea, vomiting and constipation.6 Caffeine Caffeine is added as an adjuvant to ibuprofen, aspirin and/or paracetamol products to enhance their analgesic effects: it does not have any pain relieving effect itself. Caffeine is a competitive antagonist of adenosine A1 and A2 receptors and it has been suggested that disruption of normal adenosine signalling may be responsible for its enhancement of analgesics.9 Efficacy of OTC Analgesics The relative efficacy of analgesic OTC drugs was investigated in a Cochrane systematic review.6 In general, the studies included in this review use post-operative pain (tooth extraction) as their pain model, so this should be considered when extrapolating efficacy for different types of acute pain. Aspirin, paracetamol, and ibuprofen, both alone and in combinations with each other and with codeine/caffeine were evaluated. The authors identify several knowledge gaps where not enough information was available to establish the efficacy for several OTC analgesics, including codeine plus aspirin/paracetamol, and combination products that include caffeine. The authors state that there is insufficient available data Table 1. Common acute pain conditions and the recommended, over-the-counter, evidence-based analgesia recommended by NICE (adapted from Youssef, 20197)

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53 to make a conclusion about the efficacy of low dose codeine combination therapies, and identify this as a major gap in knowledge.6 A separate Cochrane review9 looked at the efficacy of single doses of analgesics (mainly ibuprofen or paracetamol) with and without caffeine in the treatment of acute pain. Results of the Cochrane review comparing OTC analgesics6 indicate that the most favourable analgesics were combinations of ibuprofen and paracetamol (Number Needed to Treat, NNT<2). Fast acting ibuprofen formulations (200 and 400mg) had a NNT close to 2 also. The lower the NNT the better, with the ideal number NNT=1. This would be the case for an analgesic drug if every individual had good pain relief with the analgesic and no pain relief with placebo. The rate of adverse drug events experienced for these medications were generally not different from placebo. Unexpectedly, for ibuprofen plus paracetamol, adverse drug events were lower than those recorded for placebo. Co-administration of caffeine with paracetamol (or ibuprofen) was significantly more beneficial9 for pain outcomes than when the analgesic alone was administered. When caffeine (over 100mg per dose) was administered, 5% to 10% more participants achieved a good level of pain relief (at least 50% of the maximum over four to six hours). Fastacting formulations deliver good analgesia in many people with acute pain, at relatively low doses.3 NICE guidelines do not always recommend using combination analgesics as first-line treatment because using single analgesics allows independent titration of each medicine. First-line treatment recommendations vary depending on indication, and additional factors e.g. clinical presentation, suitability of treating OTC, patient co-morbidities and contraindications, need to be considered. Common treatment recommendations are summarised in Table 1.7 In terms of the cardiovascular risk associated with the use of NSAIDs, findings indicate that using NSAIDs at high doses was associated with a small increased risk5 of all-cause mortality (20% compared with placebo). However, people with chronic pain have increased rates of cardiovascular disease and a 20% increased all-cause mortality even without NSAID use, which

complicates the interpretation of these findings. Another confounder is that chronic pain has a negative effect on patient mobility which independently increases mortality. The underlying cause of the pain should be treated whenever possible, and a full therapeutic dose used before switching to a different analgesic. It is likely that, if treatment with one OTC analgesic fails, an alternative may be beneficial. Analgesic failure is common particularly when just a single dose is taken10, and unfortunately not every patient will achieve good pain relief even with the most effective drugs. Pharmacy staff should initiate conversations with patients about what the patient has taken previously (if anything) and how they have taken it in order to advise appropriately. The extensively used World Health Organisation (WHO) analgesic ladder recommends a stepwise response to pain. This ladder is often used to design treatment plans for many

types of pain, although it was developed originally for use in the management of cancerrelated pain. Guidelines on the Pharmacological Treatment of Acute Pain has been identified as a topic of future WHO guidance given the widespread influence of these WHO analgesic ladder.11 Guidelines which provide more specific, evidence-based recommendations will be a welcome tool for healthcare professionals and policy makers.

The most frequent recommendation for body pains and headache/migraine was paracetamol. While this falls in line with NICE guidance, other groups (British Association of Headache, the European Headache Federation and the European Federation for Neurological Societies) suggest that there is limited evidence for paracetamol efficacy in migraine, and that NSAIDs are more effective for tension headaches.

Pharmacy Analgesic Recommendations

Pharmacists perceive paracetamol as being safer, better tolerated, and with fewer side effects than ibuprofen for children. However, ibuprofen has been shown to provide faster, more effective, and longer lasting relief for pyrexia: it has been reported that when used at an OTC dose for up to seven days in children, there was no difference between ibuprofen and paracetamol in total rate of adverse events14, with the rates at 13.7% and 14.3% respectively. In adults, adverse events associated with ibuprofen

A survey4 of 242 pharmacists was performed to explore recommendations, and efficacy and safety perceptions, of OTC analgesics. Recommendations were made primarily based on medication safety over efficacy, although observed perceptions of safety do not necessarily reflect existing evidence. This may potentially result in suboptimal outcomes of symptom resolution in acute pain.

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54

CPD: Pain

occur more frequently at high prescription doses (>1200mg daily) and when used for more extended periods of time.4 The same adverse events seem to be associated with lower doses even though the evidence does not show this. While the survey showed that most pharmacists were aware of the safety of ibuprofen correlating with dose and duration, a high proportion did not believe there was a difference in tolerability between prescription and OTC doses. The occurrence of GI bleeds, for example, was similar with OTC dose of ibuprofen (≤ 1,200 mg; OR 1.1) and paracetamol (2,000-3,999 mg; OR 1.2). A retrospective, longitudinal, cohort study of analgesic use in the UK found that paracetamol had an overall relative risk of upper GI events of 1.36; ibuprofen had an overall relative risk of 1.18.

with water, with no reference to taking it with food.15 The summary of product characteristics should be consulted regularly to check for such updates and to advise patients on correct administration.

When pharmacists do recommend ibuprofen, we often recommend that patients take it with or after food with the aim of minimising the perceived risk of GI adverse events despite several trials showing similar rates of GI adverse events for ibuprofen vs. placebo. Taking analgesics with food significantly reduces absorption, in turn reducing efficacy, which potentially increases the likelihood or need for additional doses or alternative analgesics. Many analgesia studies are likely to have been conducted in fasting participants, so results should be interpreted while taking this into consideration.6 Recently, following review of clinical evidence by the MHRA, some patient information leaflets for ibuprofen have been updated to state that it needs to be taken

2. Schliessbach J., Maurer K. (2017) Pharmacology of Pain Transmission and Modulation. In: Yong R., Nguyen M., Nelson E., Urman R. (eds) Pain Medicine. Springer, Cham. https://doi.org/10.1007/978-3319-43133-8_2

Understanding the definition of, and mechanisms behind, pain can aid with pain assessment. When evidence-based recommendations of OTC analgesics are made while taking into consideration individual patient characteristics, this can make a significant positive impact on patient outcomes. References 1. International Association for the Study of Pain. (2020). IASP Announces Revised Definition of Pain. Available: https://www.iasp-pain.org/ PublicationsNews/NewsDetail. aspx?ItemNumber=10475

3. Wiech, K. (2016). Deconstructing the sensation of pain: the influence of cognitive processes on pain perception. Science, 354(6312), 584-587. 4. McCaul, F., Hersch, C., Kochhar, S., Maguire, T., Tisman, A., & Brown, A. (2019). Do pharmacists’ perceptions of OTC analgesia reflect existing evidence? SelfCare Journal.

5. Moore, A., Crossley, A., Ng, B., Phillips, L., Sancak, Ö., & Rainsford, K. D. (2017). Use of multicriteria decision analysis for assessing the benefit and risk of over-thecounter analgesics. Journal of Pharmacy and Pharmacology, 69(10), 1364-1373. 6. Moore, R. A., Wiffen, P. J., Derry, S., Maguire, T., Roy, Y. M., & Tyrrell, L. (2015). Non-prescription (OTC) oral analgesics for acute pain an overview of Cochrane reviews. Cochrane Database of Systematic Reviews, (11). 7. Youssef, S. (2019). Clinical guidelines and evidence base for acute pain management. Pharm J, 303(7929), 44-48. 8. Wishart DS, Knox C, Guo AC, Shrivastava S, Hassanali M, Stothard P, Chang Z, Woolsey J. Drugbank: a comprehensive resource for in silico drug discovery and exploration. Available: https://www. drugbank.ca/drugs/DB00316. 9. Derry, C. J., Derry, S., & Moore, R. A. (2014). Caffeine as an analgesic adjuvant for acute pain in adults. Cochrane Database of Systematic Reviews, (12). Available: https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC6485702/ 10. Moore, R. A., Derry, S., Aldington, D., & Wiffen, P. J. (2015). Single dose oral analgesics for acute postoperative pain in adults an overview of Cochrane reviews. Cochrane Database of Systematic Reviews, (9).

11. Kumar, N. (2007). WHO normative guidelines on pain management. Geneva: World Health Organization, 3-4. Available: https://www. who.int/medicines/areas/ quality_safety/delphi_study_ pain_guidelines.pdf 12. Van Hout, M. C., Horan, A., Santlal, K., Rich, E., & Bergin, M. (2018). ‘Codeine is my companion’: misuse and dependence on codeine containing medicines in Ireland. Irish journal of psychological medicine, 35(4), 275-288. 13. Kimergård, A., Foley, M., Davey, Z., Dunne, J., Drummond, C., & Deluca, P. (2017). Codeine use, dependence and helpseeking behaviour in the UK and Ireland: an online cross-sectional survey. QJM: An International Journal of Medicine, 110(9), 559-564. 14. Moore, N., Van Ganse, E., Le Parc, J. M., Wall, R., Schneid, H., Farhan, M., ... & Pelen, F. (1999). The PAIN study: paracetamol, aspirin and ibuprofen new tolerability study. Clinical drug investigation, 18(2), 89-98. 15. Reckitt Benckiser Healthcare International Ltd. (2020). Nurofen Express Maximum Strength 400mg Tablets Patient Information Leaflet. Available: https://www. medicines.ie/medicines/ nurofen-expressmaximum-strength-400mgtablets-33157/patient-info

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*Provides significant improvement in quit rate vs patch alone. To verify contact verify@perrigo.com. Stead LF et al. 2012 Nicotine replacement therapy for smoking cessation, Cochrane Library. **Based on sales data. To verify contact verify@perrigo.com NiQuitin CLEAR 24 hrs transdermal patches are indicated for the relief of nicotine withdrawal symptoms including cravings as an aid to smoking cessation. Indicated in adults and adolescents aged 12 years and over. NiQuitin patches should be applied once a day, at the same time each day and preferably soon after waking and worn continuously for 24 hours. Apply a patch to non-hairy clean dry skin surface, a new skin site should be used every day. Therapy should usually begin with NiQuitin 21 mg/24 hrs and reduced according to the following dosing schedule: Step1: NiQuitin Clear 21 mg/24 hrs transdermal patches first 6 weeks. Step 2: NiQuitin Clear 14 mg/24 hrs transdermal patches next 2 weeks. Step 3: NiQuitin Clear 7 mg/24 hrs transdermal patches last 2 weeks. Light smokers (less than 10 cigarettes per day) are recommended to start at Step 2 (14 mg) for 6 weeks and decrease the dose to NiQuitin 7 mg/24 hrs for the final 2 weeks. In some instances (e.g. heavy smokers, those who have relapsed after NRT, or when one NRT product is not enough to control cravings), NiQuitin patches may be used in combination with a nicotine oral format (refer to the package leaflet for dosing guidance). Contraindications: Non-smokers, hypersensitivity, children under 12 years and occasional smokers. Precaution: Supervise use if hospitalised for MI, severe dysrhythmia or CVA, if haemodynamically unstable. Use with caution in patients with active oesophagitis, oral and pharyngeal inflammation, gastritis, peptic ulcers, GI disturbances, susceptible to angioedema, urticaria, renal/hepatic impairment, hyperthyroidism, diabetes, phaeochromocytoma, seizures & epilepsy. Discontinue if severe persistent skin rash. Pregnancy and lactation: Oral formats preferable to patches unless nauseous. Remove patches at bedtime. Side effects: Sleep disorders, abnormal dreams, insomnia, headache, dizziness, nausea, vomiting, application site reactions, nervousness, palpitations, dyspnoea, pharyngitis, cough, dyspepsia, upper abdominal pain, diarrhoea, constipation, dry mouth, sweating, localised pain, urticaria, hypersensitivity, tremor, nervousness, palpitations, tachycardia, contact & allergic dermatitis, photosensitivity, arthralgia, myalgia, asthenia, malaise, influenza-type illness, fatigue, chest or limb pain, pain, seizures and anaphylaxis. Legal classification: GSL: PA 1186/18/4, PA 1186/18/5 & PA 1186/18/6. MAH: Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland. https://www.medicines.ie/medicines/niquitin-clear-7-mg-24-hours-transdermal-patch-33085/patient-info https://www.medicines.ie/medicines/niquitinclear-14-mg-24-hours-transdermal-patch-33083/patient-info https://www.medicines.ie/medicines/niquitin-clear-21-mg-24-hours-transdermal-patch-33084/patient-info NiQuitin Mini 1.5mg/4mg Mint Lozenges are used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms and cravings. Indicated in adults and adolescents aged 12 years and over. NiQuitin Mini 1.5 mg are suitable for those who smoke who smoke 20 cigarettes or less a day. NiQuitin Mini 4 mg are suitable for smokers who smoke more than 20 cigarettes a day. Place a lozenge in the mouth whenever there is an urge to smoke, allow to dissolve completely. Do not chew or swallow whole. In heavy smokers, those who have relapsed after NRT, or when one NRT is not enough to control cravings, NiQuitin Minis may be used in combination with NiQuitin patches (refer to the package leaflet for dosing guidance). Abrupt cessation: Use a lozenge whenever there is an urge to smoke, maximum of 15 lozenges a day. Continue for up to 6 weeks, then gradually reduce lozenge use. Gradual cessation Use lozenges whenever there is an urge to smoke in order to reduce the number of cigarettes smoked for up to 6 weeks, followed by abrupt cessation. Adolescents (12-17 years): only with advice from a healthcare professional. Should not quit with a combination NRT regimen. Contraindications: hypersensitivity to nicotine or any of the excipients, children under the age of 12 years and non-smokers. Precaution: Supervised use in dependent smokers with a recent myocardial infarction, unstable or worsening angina pectoris including Prinzmetal’s angina, severe cardiac arrhythmias, uncontrolled hypertensions or recent cerebrovascular accident. Use with caution in those with; stable cardiovascular diseases, diabetes mellitus, susceptibility to angioedema & urticaria, renal/hepatic impairment, phaeochromocytoma &uncontrolled hyperthyroidism, GI disease & seizures. Side effects: Nausea, mouth/throat and tongue irritation, irritability, anxiety, sleep disorders, dizziness, headaches, cough, sore throat, vomiting, diarrhoea, GI and oral discomfort, flatulence, hiccups, heartburn, dyspepsia, dry mouth, constipation, ulcerative stomatitis, pharyngitis, nervousness, depression, palpitations, heart rate increased, dyspnoea, rash, angioedema, pruritus, erythema, hyperhidrosis, fatigue, malaise chest pain, anaphylactic reactions, hypersensitivity, tremor, dysgeusia, paresthesia mouth, seizures & epilepsy, dysphagia, eructation, salivary hypersecretion, influenza like illness. Legal classification: GSL: PA 1186/18/11 & PA 1186/18/12 MAH: Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland. https://www.medicines.ie/medicines/niquitin-mini-1-5mg-mint-lozenges-33090/smpc https://www.medicines.ie/medicines/niquitin-mini4mg-mint-lozenges-33091/smpc


56

Report

Pharmacy Overview to Child Health NUI Galway report highlights trends in children’s health behaviours over 20 years The Health Behaviour in School-aged Children Trends Report 1998-2018 (HBSC) was led by senior researcher Aoife Gavin in collaboration with the HBSC research team at the Health Promotion Research Centre in NUI Galway. Dr Colette Kelly, Health Promotion Research Centre, NUI Galway

Health risk behaviours – An overall decrease across all substance use measures.  Fewer children report currently smoking – 5.3% in 2018, compared to 22.6% in 1998.  Fewer children report that they have ever been drunk – 19% in 2018 compared to 33% in 1998.  Fewer children report cannabis use in the last year – 8.5% in 2018, compared to 12.3% in 1998. Positive health behaviours – An overall improvement among young people  More children brushing teeth more than once a day – 70.1% in 2018, compared to 57.6% in 1998.  More children always wearing a seatbelt in car journeys – 81.4% in 2018, compared to 41% in 1998.

The HBSC study reveals an overall decrease across all substance use measures; an increase in young people reporting pressure from schoolwork; and more children report feeling low. Compared to the findings from 1998, the study found fewer children using substances, more than half of children exercise regularly, more children are feeling pressured by school work and more children report feeling low. The HBSC is a cross-sectional study conducted in collaboration with the World Health Organisation Regional Office for Europe. It runs every four years. In 2018, 45 countries and regions participated, collecting data on health behaviours, health outcomes and the social contexts of children’s lives. The study compared findings of health behaviour in school-aged children from 1998 to 2018. Launching the report, Minister Frank Feighan said, “I welcome the publication of this latest report from the Health Behaviour in School Aged Children Study. This international project has provided

us with essential data which has helped to shape and inform policy relating to the health and wellbeing of our children and young people.

 The proportion of young people doing vigorous exercise four or more times a week has remained stable – 52.1% in 2018, compared to 52.6% in 1998.

“This new Trends report gives us a wonderful opportunity to take stock, both of the many very significant improvements to our children’s health, and of those areas where we have not, perhaps, made as much progress as we would have liked. The information contained in this study will be of great importance in terms of future planning and policy direction regarding children’s health.”

Sexual health behaviours

Commenting on the findings, CoPrincipal Investigator Dr Colette Kelly from the Health Promotion Research Centre at NUI Galway, said, “This report is the culmination of many years of work, and brings together some good news about the health behaviours of Irish children with a sustained decrease in substance use for example. “There is a continuing positive trend in children communicating with parents and reports of good places in the local area to spend free time. The report also highlights areas in need of improvement in particular more young people are reporting that they feel pressured by school work and there is an increase in the proportion of children who report feeling low. The report provides a breakdown of age, gender and social class patterns which provide more in-depth information on each of t he indicators.”

PHARMACYNEWSIRELAND.COM

 The proportion of 15 to 17 year-olds who reported that they have ever had sex was 22% in 2018. In 2010 the proportion was 25.5%.  65.9% of young people aged 15 to 17 reported in 2018 that they used a condom at last sexual intercourse, compared to 78% in 2010. Health and wellbeing  Overall, 31% of children reported in 2018 that their health is excellent compared to 28.2% in 2002.  87.6% of children reported in 2018 that they are happy with their life compared to 88.1% in 1998.  72.8% of children reported high life satisfaction in 2018 compared to 76% in 2002.  The proportion of children who reported feeling low about every week or more frequently was 34.3% in 2018. In 1998 it was 23%.  In 2018 14.4% of children reported being on a diet or doing something else to lose weight, compared to 11.9% in 2002. • 5.3% of Irish children aged 10-17 said they were smoking in 2018, compared to 22.6% in 1998 • In 2018 19% reported they had ever been drunk, compared to 33% in 1998 • 8.5% reported in 2018 they had used cannabis in the last year, compared to 12.3% in 1998 • 44.3% reported feeling pressured by school work, compared to 32.9% in 1998 • 34.3% reported feeling low about every week or more frequently, compared to 23% in 1998


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58

Dilemma

Dilemma: What to do if a Pharmacy Staff Member Written by Niall Shanahan and Bernard Harbor, Fórsa refuses the Vaccine The Health and Safety Authority (HSA) has said that employers of workers who refuse Covid-19 vaccinations should undertake a risk assessment in cases where the staff member could be exposed to Covid-19 in the workplace. In new guidance, the agency also said employers may have “no option” but to redeploy unvaccinated staff if they are “not safe to perform certain work tasks.” Existing health and safety regulations require employers to offer vaccinations, if they’re available, when there is a risk to employees from working with a biological agent. The HSA has now updated this guidance to include Covid-19, which is defined as a biological agent. It came as HSE chief Paul Reid said health staff who declined a vaccine would have to be redeployed if they posed a risk to patients. But Fórsa officials say such instances are likely to be extremely rare, and that an agreed and reasonable approach is available off the shelf. The union’s head of health, Éamonn Donnelly, said uptake of the vaccine among health workers was going to be very high. And he said the union would draw on its

experience of the flu vaccine in developing an agreed approach to the issue. Last year, it was agreed that health staff who declined the flu jab would be subject to a risk assessment, although complications arose over the appropriate people to carry them out. Éamonn said there was an acceptance among the workforce that it was unsustainable for people to work in front-line Covid roles if they hadn’t had the jab. “I think the same will apply with the Covid-19 vaccinations. But we will need to ensure that risk assessments are conducted properly, and by qualified people, and we expect an open door for dialogue about any staff reassignments that might arise,” he said. Fórsa official Dessie Robinson – a former HSA board member who is currently part of a National Economic and Social Council team examining the psychological impact of Covid – agrees.

PHARMACYNEWSIRELAND.COM

“For the most part, particularly in the health service, vaccine takeup is going to be strong because workers want to protect their health and their families’ health. There’s been a very high take-up of flu vaccination this season, which shows the heightened sense of awareness and responsibility of healthcare staff. “Prior to the pandemic, there wasn’t anything like the same level of take-up of the flu vaccines, despite a major push every year by the HSE, which was supported by the unions,” he said. Dessie also pointed to robust existing health and safety regulation in the area. “The safety, health and welfare at work regulations require employers to make effective vaccines available if a biological agent gives rise to a risk. They also say vaccinations should be provided for free, and that the employee must be informed of the benefits and drawbacks,” he said. But Dessie added that the regulations don’t explicitly state

that an employee who refuses vaccination must be risk assessed and potentially redeployed. “That’s why the HSA recommends the application of health and safety principles of risk assessment and avoidance of risk. Under the law, employers must provide a safe place to work ‘as far as is practicable.’ This means they must take all measures within their control to ensure the safety of the workplace. “If an employee refuses vaccination, that decision increases the risk to them and their That would be very difficult to defend, especially considering the exceptional circumstances of this pandemic,” he said. Read Niall Shanahan’s blog HERE. [LINK: The end in sight: Covid vaccines and workplace safety - Forsa] It’s never been more important – or easier – to get the protections and benefits of union membership. Join Fórsa HERE: [LINK: https://www.forsa.ie/ join/] or contact us HERE. [LINK: https://www.forsa.ie/contact/] .


News HIQA Launches e-Learning The Health Information and Quality Authority (HIQA) has launched an e-learning module to help staff working in health and social care services apply a human rights-based approach to care and support for people using services. Promoting a human rights-based approach in health and social care services is a central theme in national standards developed by HIQA. This module is the first part of a wider course to help staff understand how they can apply a human rights-based approach to their work and put these elements of national standards into practice. It may also be of interest to people using health and social care services and their families, friends and advocates. The course will comprise of four modules on: • Introduction to Human Rights in Health and Social Care • The Role of Good Communication in Upholding Human Rights • Putting People at the Centre of Decision-Making • Positive Risk-Taking Rachel Flynn, HIQA’s Director of Health Information and Standards, said, “Human rights are the basic rights and freedoms that all people should enjoy. It means people are treated with fairness, respect, equality and dignity, have a say over their lives, and participate as fully as possible in decisions about their care and support. People should expect that their human rights will be promoted and protected at all times, including when they require the care and support of health and social care services.” The course aims to address knowledge and skills gaps that were identified through extensive stakeholder engagement during the development of HIQA’s Guidance on a Human Rightsbased Approach in Health and Social Care Services. Ms Flynn added: “We hope that these online learning modules will be used to strengthen and improve the experience of people accessing health and social care services across the country.”

59

Mainstay of Treatment for Appendicitis An RCSI study conducted in Beaumont Hospital in Dublin has found that surgery, rather than antibiotics-only, should remain as the mainstay of treatment for acute uncomplicated appendicitis. Professor Arnold Hill, Head of School of Medicine, Professor of Surgery, RCSI

The study, entitled the COMMA trial (Conservative versus Open Management of Acute uncomplicated Appendicitis) examined the efficacy and quality of life associated with antibiotic-only treatment of acute uncomplicated appendicitis versus surgical intervention. The results revealed that antibioticonly treatment resulted in high recurrence rates and an inferior quality of life for patients. In this research, 186 patients with radiological evidence of acute, uncomplicated appendicitis were randomised to two groups. One group received antibiotic-only treatment and patients in the other group were treated with surgery. Patients in the surgery group underwent a laparoscopic appendectomy. In those treated with antibiotics-only, intravenous (IV) antibiotics were administered until there was an improvement in a patient’s signs and symptoms and this was followed by five days of oral antibiotics. In the weeks and months following treatment, patients were followed up with questionnaires including a quality of life questionnaire at

1 week, 1 month, 3 months and 12 months. At these points, the patient’s pain score, need for additional sick leave, surgical site infections and the development of recurrent appendicitis were recorded. The results from the antibioticonly group demonstrated that 23 patients (25%) experienced a recurrence of acute appendicitis within one year. In the quality of life questionnaires, it was found that patients in the surgery group experienced a significantly better quality of life score compared with the antibiotic-only group. Professor Arnold Hill, Head of School of Medicine and

Professor of Surgery, RCSI, said, “Antibiotic-only treatment of acute uncomplicated appendicitis has been proposed as an alternative less-invasive treatment option for patients. The COMMA Trial set out to establish if antibiotic-only treatment could replace surgery in some cases, which could offer many benefits for patients and hospitals alike. The results indicate that the treatment protocols should not change. Surgery will deliver the best outcomes for patients in terms of quality of life and recurrence and therefore should remain as the mainstay of treatment for acute uncomplicated appendicitis.”

‘Trust’ – Focus of World Pharmacists Day “Pharmacy: Always trusted for your health” will be the theme of World Pharmacists Day on 25 September, the International Pharmaceutical Federation (FIP) has announced. At a time when trust barometers have found that distrust of societal leaders has increased and distrust of information sources is at a record high, fuelled by the Covid-19 pandemic and the infodemic around it, and when vaccines hesitancy remains a major hurdle, public trust in pharmacy is more important than ever. For many years, pharmacists have consistently been named among the top five most trusted professionals in national surveys. Educators are also consistently in the top five and, according to

a recent survey, scientists are the most trusted people in the world. “Pharmacists, educators and scientists — that’s our pharmacy profession,” said FIP president Dominique Jordan.

around the world to join this year’s campaign,” Mr Jordan added.

“Evidence indicates a significant association between trust in healthcare professionals and health outcomes for patients. Pharmacy has built up a reserve of trust over many years of caring, and we can put this trust to good use in countering the anti-vaxxers as well as in continuing to improve the health of our communities in general. I invite all my colleagues

PHARMACYNEWSIRELAND.COM


OTC & Retail Pharmacy Product Awards One of the most anticipated events within the over-the-counter market in Ireland, the OTC & Retail Pharmacy Product Awards were shortlisted and judged during early March. Historically at this time of year, the team at IPN Communications would typically be welcoming representatives from the finalist manufacturing companies, judges and invited guests to our awards ceremony in Dublin – to celebrate and recognise excellence and innovation within the OTC sector. Unfortunately, due to the current and ongoing climate it was not possible to host the event for 2021. We are deeply disappointed that, for the second consecutive year, we haven't been able to do so. We were overwhelmed with the entries for this years awards; as the judges stated, each year the quality and quantity continues to get higher, making for a very difficult judging process. Our esteemed panel of over 40 judges were from across the community pharmacy sector, representing both multiple and independent pharmacies, buying groups, wholesalers and industry, and were able to judge the categories remotely. OTC & Retail Pharmacy Product Awards are one of the largest events in Ireland’s retail pharmacy sector, with 19 categories ranging from Best Baby Skincare Product and Best Women’s Product to Best Launch and Best Marketing/Training Campaign. OTC & Retail Pharmacy Product Awards are the only industry awards that specifically recognise and reward the companies and their products within the OTC market. Created in 2015, they recognise Ireland’s best OTC and retail pharmacy products. The awards applaud the investment by these companies, both large and small, into product development, training, marketing initiatives and promotional campaigns. The winners across our categories were contacted by the IPN team with the news and feedback. Over the following pages we feature all the winners and details on product selection from members of the judging panel.

60 | PHARMACYNEWSIRELAND.COM


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Most Innovative Product Solvotrin’s Active Iron Pregnancy Plus were the winners of the 2021 Most Innovative Product Award. This product has been specifically developed to optimise vitamin and mineral absorption while being kind on the stomach. Containing 21 essential nutrients, like iron, omega 3 and folic acid, it delivers the optimum combination, to provide complete care for mum and baby. Active Iron Pregnancy Plus includes 30 capsules of the strongest 25mg dose of Active Iron non-constipating formula, with 2x better absorption and clinically proven to increase iron levels, making it both Kind & Strong.

This is an excellent product – It does very well for us in such a busy sector with a lot of similar brands. The launch was very successful and it has enjoyed great performance. The packaging is great for on shelf presence” Judges comments

Nuasan Active Bodycare Kit Nuasan

Pat O’Flynn, CEO, Solvotrin

MyPro Diacare Pharmed Ltd

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For enquires please contact: enquiries@flexiseq.com • 087-2953582


Best Non-Oral Pain Relief Product Flexiseq Max Strength by Ascension Healthcare won the 2021 Award for Best Non-Oral Pain Relief. By way of affirmation, one judge is quoted as saying it ‘is our most popular drug free pain relief gel.’ Flexiseq Max Strength is a topically applied gel specially formulated to help fight against the effects of osteoarthritis and joint wear & tear. Entirely drug free, Flexiseq can be used long-term and alongside traditional pain medications without drug-to-drug interactions, free from systemic side effects or exacerbating preexisting conditions. Through its lubricating action, Flexiseq’s Sequessome Technology offers a unique treatment option. Flexiseq Osteoarthritis is clinically proven*, drug free relief from the pain and stiffness of osteoarthritis. A drug-free, sustainable solution to effectively relieve the pain and stiffness of osteoarthritic joints to keep you moving.

This is an excellent product, whose repeat customers all speak very highly of its benefits Being drug free, it is very easy to sell along with other medications that the patient may be currently on. A worthy winner in my eyes”

Allie Forde Marketing Manager Ascension Healthcare

Judges comments Physiologix Range Fleming Medical

Body Clock TENS- New Vision Healthcare

Voltarol Emulgel Extra Strength 2% w/w Gel GSK Consumer Healthcare

Incrediwear Knee Sleeves - Simply Natural


Best VMS Product Zest Active, by Revive Active came out on top to win the Best VMS Product 2021 – A product that has become a very popular choice in the Revive Active range, commented the judges. Zest Active is an innovative super supplement from Irish Supplement company Revive Active.  Zest Active is scientifically formulated with 25 active ingredients including vitamins, minerals, amino acids and Wellmune®, all carefully selected to support energy, the immune system, brain, and muscle function.  Each sachet contains a range of B Vitamins (Riboflavin (B2), Niacin (B3), Pantothenic Acid (B5), B6, Folic Acid (B9), B12 which ensures that Zest Active contributes to a normal energy-yielding metabolism.  It contains a natural sweetener, steviol glycosides and is suitable for vegetarian, vegan, diabetic, and gluten free diets. With a refreshing orange flavoured blend, Zest Active delivers the daily nutrients you need, to help you unlock your true potential.

A brand that customers love and trust – a product that is always in demand in pharmacy and well supported - Its once daily dose in the form of a sachet to drink has made it very convenient to take; The advertising and promotional offers have increased brand awareness and loyalty to the product is immense” Judges comments

Daithi O'Connor Founder and MD of Revive Active

Minami Platinum Elite + 1000IU Vitamin D - Minami

Love Your Immunity - Healthspan

Centrum GSK Consumer Healthcare

BabyD, ToddlerD & BabyD - Kora Healthcare


TWO WINS FOR IRISH

SUPER SUPPLEMENT RANGE As voted by the Retail Pharmacies of Ireland 2021

Judges commented that This Irish product has revolutionised the vitamin and mineral market

Judges commented that It’s once daily dose in the form of a sachet to drink has made it very convenient to take as there is no need to take several different products

What is the difference between Revive Active & Zest Active? Revive Active is tailored for those over the age of 35, with 26 active ingredients. It contains additional ingredients, including 150mg CoQ10 which is critical for cellular energy and depletes naturally as we age and 3,000mg L-Arginine. Zest Active is tailored for those aged 18-35, with 25 active ingredients and contains the ingredient Wellmune®, a beta glucan by the Kerry Group.

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Best Eye Care Product TheaPamex made it two-in-a-row as their product, Thealoz® Duo won the Best Eye Care Product for 2021. Thealoz® Duo is Europe’s No 1 Dry Eye drop solution and a pioneering product that has been widely credited for opening new doors and horizons in eye care and ophthalmology. It is the most advanced preservative-free combination of sodium hyaluronate and trehalose for moderate to severe dry eyes, in a hypotonic formulation that can be used with contact lenses.

This is becoming a widely prescribed product, with proven therapeutic benefits in treating dry eye. The fact that it is safe for use for 3 months after opening is also an attractive feature of this product and offers good value to the user” Judges comments Diarmuid Gavin, Country Manager, Theapamex

Uriage Xémose Soothing Eye Contour Care Uriage – distributed by Graham Anthony

Atoderm Intensive Eye - NAOS Skin Care Ireland Ltd

Macu-SAVE Pharmed Ltd.

Hy-Opti Eye Drops Rowex


Best Oral Health Product Best Oral Health Product for 2021 went to The Sonic Toothbrush. “This is a really good performer. Spotlight Oral Care have really done well with the brand,” commented one of the judges. Spotlight Oral Care’s Sonic toothbrush is scientifically proven to help keep gums healthy, remove plaque and stains and stop tooth decay. A game changer, the Sonic Toothbrush uses professionally designed sonic technology which allows the gentle feel of a manual toothbrush with an actual deep clean effect. Efficient, high-frequency brush movements ensure both toothpastes and oxygen are delivered to even the most inaccessible places. The sonic toothbrush was designed with both efficiency and comfort in mind which makes it gentle and effective in removing plaque and discoloration, ensuring an amazing clean and in turn, long term oral health. Three different settings with various amplitude ranges suit every individual need. It's important to remember we only get one set of teeth and they don't grow back!

This is a great oral product, which is very well advertised and easy to sell for pharmacies with a high value – I love that there are 3 different settings, and the long battery life!” Judges comments

Lisa Carmody, PR & Influencer Manager, Spotlight Oral Care

Bevery Hills Formula Perfect White Extreme White Toothpaste – Purity Laboratories Ltd.

Jordan Green Clean Adult Toothbrush - Eurosales International

Kin Gingival Complex Mouthwash Pamex Ltd.


Best Cough, Cold and Flu Product Lemsip won the title for Best Cough, Cold and Flu Product at the 2021 OTC & Retail Pharmacy Product Awards. As one of the judges remarked, “There is no other cold remedy known to so many customers.” Lemsip’s range of effective cold and flu remedies have been tried and trusted for generations. Over the years our product range has extended, and we offer a wide range of formats from capsules, tablets and liquids to the more traditional hot drink sachets, so you can recommend a product that best suits your patient’s combination of cold and flu symptoms - whether they are aches and pains, sore throat, cough & blocked noses.

This is a recognsable brand that performs very strongly in its category. It has brilliant support and in-store activations; Lemsip is a brand strongly associated with the cough and cold market in Irish pharmacy; Pharmacy support is always good with POS always available and the company keen to engage with the sector” Judges comments

Vicks First Defence Procter & Gamble

Marie Farrington, Brand Manager, Reckitt

Night Nurse Liquid - GSK Consumer Healthcar

SaltAir UV - Kilkenny Salt Therapy

A.Vogel Echinaforce® Sore Throat spray - Wholefoods Wholesale



Best Digestive Product Alflorex® by PrecisonBiotics won the Best Digestive Product – A superb product with repeat custom month after month, said the judges. The unique 35624® culture in Alflorex® has been clinically tested by leading scientists and gastroenterologists. Alflorex® is the only product in Ireland that contains this culture. It has been recognised by an expert panel of Irish pharmacists and industry experts, voting it the winner of Best Gastrointestinal Product 4 years in a row at the Irish Pharmacy News OTC Awards. The bacterial culture in Alflorex® occurs naturally in the human gut. It's part the Bifidobacterium family, one of the first kinds of bacteria passed by mothers to their babies at birth. To ensure this natural culture reaches your gut with its properties intact, PBG has created a special formulation and confirmed it's activity in the gut using the highest standards of scientific testing and human clinical trials.

Alflorex is a consistent high performer in terms of sales and customer satisfaction and response. Peer reviewed evidence based effectiveness can be hard to come by in the supplement category so this is very beneficial. Similarly, being stored at room temperature is a major benefit for customer & pharmacy compared to competitors” Judges comments Nexium Control - GSK Consumer Healthcare

Colm O’Sullivan, Head of Communications, Sara Beltoise, Marketing Director, Aishling Forde, Careline Advisor & Business Support, PrecisionBiotics Group

Bio-Kult Boosted Multistrain Supplement - Scope Healthcare

Gaviscon Reckitt


Introducing the Voltarol Emulgel Extra Strength 2% w/w Gel easy-to-open cap* Powerful Anti-Inflammatory Provides All-Day Joint & Muscle Pain Relief** Making life easier for your patients with pain in their hands Contains a unique permeation enhancer – up to 3x increased skin permeation of diclofenac†1 Clinically proven to demonstrate deep penetration into tissue2 Reduces pain on movement – to help patients get moving again

Patient convenience – twice daily application for clinically proven 12 hour-pain relief

The No 1 selling topical pain relief brand3 Find out more at our dedicated healthcare website GSKHealthPartner.com *100g pack only. **with twice daily application. †compared with Voltarol Emulgel 1% in vitro study. 1. Quartarone & Hasler-Nguyen 2014; GSK data on file 2. Seefried et al. Ther Adv Musculoskel Dis (2020) Vol. 12: 1-13. 3. GSK data on file, IQVIA value sales data MAT w/c 28/02/2021. Product Information: Please consult the Summary of Product Characteristics for full product information. 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: 2g to 4g of gel, applied topically 2 times daily – morning and evening. Maximum recommended treatment duration is 14 days. 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 or other non-steroidal anti-inflammatory drugs. Hypersensitivity to any other ingredient of 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. It should not be used with occlusion. It should not be allowed to come into contact with the eyes or mucous membranes and should never be taken by mouth. Application over extensive areas for prolonged periods or application in excess of recommended dosage may give rise to systemic effects. These include gastrointestinal disturbances and bleeding, irritability, fluid retention, rash, hepatitis, renal dysfunction, anaphylaxis and rarely blood dyscrasias, bronchospasm and erythema multiforme. 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. Pregnancy and lactation: The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. Only use during lactation on the advice of a health professional. Contraindicated during the third trimester of pregnancy. Should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time. 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. Overdose: The low systemic absorption of topical diclofenac renders overdosage extremely unlikely. MA Holder: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. MA Number: PA 678/140/3. Legal Category: Pharmacy only. Text revised: June 2020. Further information available on request. Contains diclofenac diethylammonium. Always read the label/leaflet. Trade marks are owned by or licensed to the GSK group of companies. PM-IE-VOLT-21-00011.


Best Pain Relief Product GSK Consumer Health’s Voltarol Emulgel Extra Strength 2% w/w Gel won the Best Pain Relief Product category for 2021. Voltarol Emulgel Extra Strength 2% w/w Gel is a Powerful Antiinflammatory that targets the source of pain and can be applied twice a day to provide all-day relief from joint & muscle pain. New 100g pack comes with a unique easy-open Flip-top cap to make life easier for your patients suffering from pain in their hands. This 100g tube is equivalent to 72x 200mg tablets of ibuprofen and has a reduced risk of systemic side effects or drug-drug interactions.

This is a great product to have the option to recommend especially for those with whom oral NSAIDs are not tolerated or contraindicated. Given the choice of topical preparations, almost all customers will choose the Voltarol 2%. The twice daily dosing aids compliance greatly. The advertising campaigns have made the Voltarol brand very identifiable and trusted amongst customers. Customer loyalty to the brand is substantial” Judges comments

Solpa-Extra Perrigo

Stuart Hutchison, Pan Ireland Pharmacy Controller, GSK Consumer Healthcare

Brupro Max 400mg Rowex

Incrediwear Knee Sleeves Simply Natural

Sumatran Relief 50mg Tablets x2 Rowex


Best Womens Product NuaBiome Women by Nua Fertility beat the competition to win the Best Womens Product 2021. Nua for Women is the first-of-its-kind, pre-natal fertility supplement with a gut health focus which combines key vitamins, minerals and good bacteria tailored to help support female fertility. Nua for Women is an all-in-one capsule recommended by doctors for women who are thinking, planning or trying for a baby. The bespoke formula concentrates on the essential nutrients to support preparation for pregnancy and healthy conception. The good bacteria supports the gut to function optimally and strengthens vaginal health. Nua Fertility is proud to have brought this innovative Irish brand to market, backed by science and inspired by personal experience of infertility.

It is great to see such Irish innovation again with this new product. The research that has gone into this is incredible - Really innovative product with lots of USP's. Great brand to have in the pharmacy. One to watch for the future” Judges comments Deborah Brock, CEO, Nua Fertility

Active Iron Pregnancy Plus - Solvotrin Therapeutics

Utipro® Plus AF Pamex Ltd.

Bio-Kult ProCyan Multistrain Supplement - Scope Healthcare


Best Beauty Product Nuxe Ireland’s Huile Prodigieuse won the Best Beauty Product category 2021. “A pharmacy and bathroom cabinet essential,” is how one judge remarked about this product. With seven precious botanical oils and 98% of natural ingredients, this legendary skincare treatment provides long-lasting hydration for the face, body and hair. Its antioxidant action, anti-pollution properties and its efficacy on stretch marks are unique, just like its inimitable dry oil texture and its addictive fragrance. Committed to women’s beauty and to the environment, it truly embodies Nuxe’s values in the world of the French Pharmacy: nature, science and hedonism.

This is a well established cult beauty product and sells exceptionally well. The brand is well supported and is growing every year - This product is long established in the beauty industry. It is yet to be beaten as Number 1 product brand in the dry oil category” Judges comments Marie-Laure Bruckert, General Manager, Nuxe Ireland

Skin Magic Wonder Balm - TanOrganic

Vital Proteins Collagen Peptides Nestle

Filorga Time-Filler Wrinkle Correction Cream - Filorga - Distributed by Graham Anthony Distribution

Codex BIA Skin Superfood - Codex Beauty Labs


Vivimune

TM

The new name for Vivoptal Junior. Now with increased Zinc and added Iodine to support immunity and cognitive development.

Daily immune system support Vivimune™ is a soothing liquid with Elderberry and other carefully selected powerful ingredients from nature.

COUGH SYRUP

A 100% natural and preservative free cough syrup, specifically formulated for children 1 year+ for both dry and congested cough.

NEW from

available from your local wholesaler

For more information visit www.scopehealthcare.ie

W NE

* PREVIOUSLY


Best Children & Baby Product Vivio Junior Multivitamin Tonic by Scope Healthcare by won the 2021 Award for Best Child and Baby Product. “Vivio Junior is a great, fast selling line,” remarked one of our esteemed judges. Vivioptal Junior is now VIVIO® Junior! This familiar heritage brand has been enhanced and improved to meet the demands of modern day life for kids. It is still packed with all 12 vitamins loved before, including Vitamin D, C and B12 but now with increased levels of zinc and added iodine to support growth in children, their immune system and cognitive function. VIVIO® Junior is a delicious tasting multivitamin tonic suitable from 1year+ and specifically formulated in accordance with the latest research and nutrient guidelines for children.

This rebrand is a major positive and looks much more oriented to children than the previous version. The clear information about the benefits of the various vitamins on the side of the package is a great sales tool and helps parents with selfchoice from the shelf. In a competitive market, parents seemed to show loyalty to the previous version and I think this will be reinforced by the rebrand”

Sarah Ussher, Product Manager, Scope

Judges comments Junior Revive Revive Active

MyPro Kolicare Pharmed Ltd.

BabyD & ToddlerD Kora Healthcare



Best Marketing/ Training Campaign Nurofen took the title of Best Marketing/Training Campaign of the Year for 2021. At Nurofen, consumer safety is the number one priority. Ibuprofen is a well-established medicine that has been used with a good safety profile as a fever and pain reducer, for more than 30 years. Say Reckitt, “As a responsible, science-led organisation, we are always engaging with the relevant health authorities. We remain committed to communicating any additional information or guidance necessary for the safe use of our products should the need arise. At Reckitt we wanted to share the facts with consumers and HCPs to ensure they could make an informed decision about the OTC pain relief product that was right for them. “We launched the biggest ever PR and Marketing campaign in Nurofen’s history: The ‘Share the Facts’ campaign was a Category focused approach. Nurofen Rapid Relief Maximum Strength 400mg Liquid Capsules contain Ibuprofen. For mild to moderate pain and fever. Always Read the Label.”

A really strong campaign seen by all; Quick reaction to negative press and successful in changing a negative perception around ibuprofen and covid. A beneficial campaign and message for the total pharmacy sector – The market leader in analgesics. Targets site of pain within all age groups”

Bridget Barcoe, Brand Manager Reckitt

Judges comments

GSK Health Partner

GA Training Graham Anthony Distribution

health partner

Skin Conscious Magazine and Website – RELIFE Marketing Campaign 2020

Incrediwear Knee Sleeves Simply Natural


Date of Item Dec 2020 IE20071 IR-REL-120-2020

DRY & ROUGH SKIN UNDER CONTROL, FROM HEAD TO TOE

Clinically proven for use all over the body with moisturising and keratolytic formulations even for plaques associated with psoriasis. Let your skin benefit from U-LifeTM, the one-stop solution with moisturising and keratolytic action for the management of dry, very dry, and chapped skin in specific areas of the body. U-LifeTM creams and anhydrous pastes are formulated with different urea percentages plus other specific ingredients to meet your skin’s needs and target specific areas (scalp, face, body, hands and feet).

RELIFE™ MY SKIN SAYS HOW I FEEL. WWW.RELIFE.IE


Best Hair, Nail and Scalp Health Product Menarini Group RELIFE’s U-Life 10 ecofoam won the title of Best Hair, Nail and Scalp Product at the 2021 OTC & Retail Pharmacy Product Awards. U-Life 10 ecofoam is a moisturising and smoothing foam with urea (10 per cent) that is specifically formulated for the scalp and is part of the second product range, which RELIFE, the Italian, dermatology and aesthetics skincare brand, has launched to the Irish market. The U-Life range of products is specifically for the face, body, scalp, hands, feet, and for localised areas of hyperkeratosis offering relief for dry, rough and thickened skin at varying concentrations; and offers innovative solutions for people with common skin complaints. U-Life contains urea, which maintains the skin's hydration levels and also possesses keratolytic properties helping to exfoliate and soften dry, hard skin. In a study of users with seborrheic or psoriasiform dermatitis of the scalp, consecutive use of the U-Life 10 ecofoam product once daily for 28 days significantly reduced the skin peeling/shedding in 85 per cent of users.

This is a super product. I have recommend this many times and always with great success. It’s wonderful to have an effective product to recommend that is steroid free and doesn’t require a visit to the doctor. The foam application is also much more desirable than some of the scalp lotions on the market” Judges comments Phyto Novathrix Happy Scalp Brush Phyto - Distributed Global Beauty by Graham Anthony Ireland Distribution

Johnny Murphy, Head of Consumer Health, A.Menarini Pharmaceuticals Ireland

Skin, Nails and Hair Formula - Solgar

Naturigin Simply Natural


IRELAND’S No.1

Sleep AId BRAND CLINICALLY

PROVEN

CAN HELP YOU GET A GOOD NIGHT’S SLEEP *To verfiy contact verify@perrigo.com. Based on IQVIA sales data. Nytol One-A-Night 50 mg Tablets contains diphenhydramine hydrochloride. A symptomatic aid to the relief of temporary sleep disturbance in adults. Adults: One tablet to be taken 20 minutes before going to bed, or as directed by a physician. Do not exceed the maximum dose of one tablet in 24 hours. Elderly patients or patients with liver or kidney problems should consult their doctor before taking this medicine. Children under 18 years: Not recommended. The product should not be taken for more than 7 days without consulting a doctor. Contraindications: hypersensitivity to the active substance or to any of the excipients, stenosing peptic ulcer, pyloroduodenal obstruction, phaeochromocytoma, known acquired or congenital QT interval prolongation, known risk factors for QT interval prolongation. Special warnings and precautions: pregnancy/lactation, renal and hepatic impairment, myasthenia gravis, epilepsy or seizure disorders, narrow-angle glaucoma, prostatic hypertrophy, urinary retention, asthma, bronchitis, COPD. Patients should be advised to promptly report any cardiac symptoms. Tolerance and / or dependence may develop with continuous use. Do not take for more than 7 consecutive nights without consulting a doctor. Should not be used in patients currently receiving MAO inhibitors (MAOI) or patients who have received treatment with MAOIs within the last two weeks Use in the elderly should be avoided. Avoid concomitant use of alcohol or other antihistamine-containing preparations. Do not drive or operate machines. Cases of abuse and dependence were reported in adolescents or young adults for recreational use and/or in patients with psychiatric disorders and/or history of abuse disorders. Contains lactose. May suppress the cutaneous histamine response to allergen extracts and should be stopped several days before skin testing. Interactions: Alcohol, CNS depressants, MAO inhibitors, anticholinergic drugs (e.g. atropine, tricyclic antidepressants), metoprolol and venlafaxine, CYP2D6 inhibitors, Class Ia and Class III anti-arrhythmics. Side effects: sedation, drowsiness, disturbance in attention, unsteadiness, dizziness, thrombocytopenia, hypersensitivity reactions, confusion, paradoxical excitation, convulsions, headache, paraesthesia, dyskinesias, blurred vision, tachycardia, palpitations, thickening of bronchial secretions, dry mouth, gastrointestinal disturbance, muscle twitching, urinary difficulty, urinary retention, fatigue. Legal classification: P: PA1186/016/001 MAH: Chefaro Ireland DAC. The Sharp Building. Hogan Place. Dublin 2. Ireland. SPC: https://www.medicines.ie/medicines/nytol-one-a-night-50-mg-tablets-34889/smpc IRE NYT 2021 09


Best Launch of the Year Having launched in January of 2020, Perrigo’s Nytol One-A-Night won the Best Launch of the Year category at the 2021 OTC & Retail Pharmacy Product Awards. “There’s no competition for this OTC medication and it’s great to see it as an addition to the pharmacy backwall,” commented one of the judges. Perrigo launched Nytol One-A-Night in January 2020 and it is now Ireland’s no 1 sleep aid brand. Nytol One-A-Night is available over the counter in pharmacy to help customers suffering from temporary sleep disturbance. Nytol One-A-Night can be taken for up to 7 nights to help get the sleep pattern back on track. Each tablet contains 50mg Diphenhydramine Hydrochloride, which can help those suffering from temporary sleep disturbance.

This is a great product, which has been backed by a strong advertising campaign. It enjoys a high degree of customer loyalty Supplier support is excellent from POS to training packages for pharmacies; a key driver in the OTC category in pharmacy” Judges comments

Vital Proteins Collagen Peptides Nestle

Catherine O’Connor, Brand Manager, Perrigo

New Vision Skincare - New Vision Healthcare

Water Flosser Launch - Spotlight Oral Care

Dettol Reckitt


Available from:


Best Natural Product A.Vogel Echinaforce by Wholefoods Wholesale won the Best Natural Product for 2021. A.Vogel Echinaforce® Cold and Flu drops and tablets are a licensed traditional herbal remedy for colds and flu. It helps the body fight the symptoms of these infections by supporting the immune system, helping to maintain the body's resistance. Their Echinacea is produced using extracts of freshly harvested, organically grown Echinacea purpurea herb and root, picked fresh and used within 24 hours of harvest. A.Vogel Echinaforce has been scientifically proven to prevent the development of colds, flu and respiratory tract infections. A study by the Common Cold Centre (Cardiff) on the preventative use of Echinacea (Echinaforce) over a 4-month period. The development of recurrent colds reduced by 59 per cent, as well as the severity of cold symptoms. In September 2020, an invitro study in Switzerland published in The Virology Journal revealed that a fresh, whole plant liquid extract of Echinacea purpurea could be effective as prophylactic treatment for a spectrum of human coronaviruses, including newly occurring strains such as SARS-CoV-2 (CoVid-19).

This is a well-established brand with an important customer segment within pharmacy; Packaging is effective highlighting USPs and appealing to the consumer” Judges comments

Alflorex PrecisionBiotics

Shane Kilboyle, Brand Manager, Wholefoods Wholesale

BabyD, ToddlerD & BabyD Kora Healthcare

Immune Phix Phytaphix


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Created with a love of natural beneficial ingredients and the joy experienced living with great skin. Scientifically formulated and dermatologically tested we create skincare products that are nourishing, soothing, and beautiful to apply.

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Enjoy the skin you’re in L OUTLO

Leaving you Feeling Good and ready to have a great day!

New Wholesale Online Ordering Platform To see our full range of products and to avail of our easy online ordering: Create your wholesale login today www.newvision.ie/wholesale Receive 10% off your first order when you sign up for our newsletter.

sales@newvision.ie | +353 83 377 3344

S K I N C A R E


Best Skincare Product Ilumesa Hyaluronic Eye & Neck Serum from New Vision Healthcare won the Best Skincare Product 2021. “This is a great product in what is a competitive market,” noted one of the judges. Ilumesa is a refreshing and revitalising hyaluronic eye and neck serum recommended for reducing the appearance of fine lines and brightening the skin. Enriched with 2% premium hyaluronic acid and natural moisturizing ingredients: aloe vera, panthenol (pro vitamin B5) and Jojoba. The unique nourishing formulation helps to slow down the skin aging process. The light and delicate texture is pleasant to apply leaving the skin feeling refreshed and radiant. Created by Irish brand, New Vision Skincare, Ilumesa is dermatologically tested with ‘Excellent’ score by DermaTest Germany and attractively priced at ¤32.00 RRP.

This is a lovely Irish brand with top quality ingredients. Treating both eyes and neck (2 in 1), this product can enjoy huge customer interest. Within an already competitive market this product, a well supported brand, really stands out” Judges comments

Benoxor Cream Citrine Healthcare Ltd

Niamh Cherry, Retail Sales Manager New Vision

Eucerin Aquaphor Soothing Skin Balm - Beiersdorf

RELIFE U-Life Range - RELIFE Ireland by the Menarini Group

Huile Prodigieuse NUXE Ireland


Best Baby Skincare ABCDerm Péri-oral won the Best Baby Skincare Award category 2021. Treatment to soothe, purify and protect irritated skin around the mouth of babies and children. This irritation caused by saliva coming into contact with the skin (repeated rubbing of a dummy, thumb or favourite object) may be maintained or aggravated by the cold and wind. ABCDerm Péri-oral contains the Amylpriv™ patent that inhibits the activity of amylase, an enzyme present in saliva that may be irritating to the delicate skin around the mouth. Péri-oral combines an insulating and protective texture with purifying, soothing and protective dermatological agents to: - Promote the decrease of perioral irritations - Participate in reinforcing the cutaneous barrier - Soothe redness and help restore skin comfort Can be used from birth (except premature babies).

This is a fantastic product which works exceptionally well for a very common problem. There is nothing as effective on the market currently, it is really unique and a product which every family should have” Judges comments

Anna Zupinska, Marketing Operations Manager, Division Bioderma, Naos Skin Care Ireland

Mustela Stelatopia Balm - Mustela - Distributed by Graham Anthony Distribution

RELIFE Relizema spray&go – zinc + panthenol - RELIFE Ireland by the Menarini Group

Elave Sensitive Sun Paediatric SPF50+ - Gardiner Family Apothecary


Best Pharmacy Only Product Making it a double win for GSK Consumer Health, Voltarol Emulgel Extra Strength 2% w/w Gel also won the Best Pharmacy Only Product 2021. This product, according to a member of the judging panel, has customer loyalty which is immense. ‘The 2% higher strength is a very popular choice amongst customers and the twice daily dose has increased compliance and aids ease of use.’ Voltarol Emulgel Extra Strength 2% w/w Gel is a Powerful Antiinflammatory that targets the source of pain and can be applied twice a day to provide all-day relief from joint & muscle pain. New 100g pack comes with a unique easy-open Flip-top cap to make life easier for your patients suffering from pain in their hands. This 100g tube is equivalent to 72x 200mg tablets of ibuprofen and has a reduced risk of systemic side effects or drug-drug interactions.

Excellent product; innovative in it’s high strength formulation, well marketed. This is a brand that is instantly recognisable - Supplier investment in promotional materials and training is really strong” Judges comments Stuart Hutchison, Pan Ireland Pharmacy Controller, GSK Consumer Healthcare

Nytol One A Night Perrigo

Ginkgo Biloba Pharma Nord

Sumatran Relief 50mg Tablets x 2 Pharma Nord


Best Irish Pharmacy Brand Product Revive Active made it a double-win at the 2021 OTC & Retail Pharmacy Product Awards as they took home their second title of Best Irish Pharmacy Brand Product. Revive Active is an award-winning super supplement with 26 active ingredients working together, helping put back what life takes out. This Irish super supplement is delivered in powdered format and contains a comprehensive combination of vitamins, minerals and amino acids in one convenient daily powdered sachet. The daily sachet can be added to water, juice or a smoothie and due to the powdered format, it offers higher bioavailability as vitamins and minerals dissolved in liquid form are absorbed in the body more easily than in tablet or capsule form. The product is designed for active people balancing work, home and family life while maintaining a healthy immune system, heart health and energy.

This Irish product has revolutionised the vitamin and mineral market. It demonstrates superb results, is pleasant tasting and a great product for patients and pharmacies alike. It is fantastic to support an innovative Irish brand that really works. This Product is used by all my staff which in itself speaks volumes” Judges comments

Daithi O'Connor Founder and MD of Revive Active

Vitamin D3 2000iu Mylan - Mylan/ Viatris

Elave Sensitive Sun Paediatric SPF50+ - Gardiner Family Apothecary

Panadol Extra Soluble GSK Consumer Healthcare

Active Iron Pregnancy Plus - Solvotrin Therapeutics


SPOTLESS...

Different acne, different needs.

Protect the skin you’re in www.citrinehealthcare.com | Tel: 01 445 7206



Feature: UTIs

95

Urinary Tract Infections Written by: Theresa Lowry Lehnen CNS, GPN, RNP and PRO IPNA - Irish Practice Nurses Association Urinary tract infection (UTI) is the collective term used to describe infections involving any part of the urinary tract, which includes the kidneys, ureters, bladder and urethra. Infections of the bladder (cystitis) and urethra (urethritis) are known as lower UTIs and infections of the kidneys (pyelonephritis) or ureters are classed as upper UTIs.1, 4 The urinary tract is the second most common site of bacterial infection and a significant cause of morbidity both in terms of the number of people affected and potential complications. UTI's are classified as complicated or uncomplicated. An infection is considered complicated if it affects pregnant women, children, men and the elderly orif it affects the upper urinary tract. Uncomplicated UTI's involve the lower urinary tract and cause acute dysuria and frequency in otherwise healthy, non-pregnant women.4 The urinary tract is a common source of infection in paediatrics and is the most common bacterial infection in children under 2 years of age, both in community and hospital settings. Approximately 8% of girls and 2% of boys will have a symptomatic UTI in childhood. During the first six months of life however, UTIs are more common in boys than girls and especially in uncircumcised males. E. coli is the causative organism in 90% of cases. 30% of children with UTI have vesicoureteric reflux. Accurate diagnosis via urine culture is essential.2, 10 The incidence of UTIs in adult males under age 50 years is low. Up to 40% of women develop a UTI at some point in their life compared to 12% in men. In men, cystitis is often associated with infection and inflammation of the prostate gland (prostatitis). Anatomically the female urethra is shorter and located closer to the anus than in males, which makes it easier for bacteria to reach the female urethra and bladder. Adult women are 30 times more likely than men to develop a UTI, with almost half of them experiencing at least one episode during their lifetime and one in three women experiencing their first episode by the age of 24 years. UTIs are most commonly seen in sexually active young women. Sex can irritate and weaken the urethra, making it easier for bacteria to enter. Certain contraceptives can increase a woman’s risk of developing UTIs. These include the diaphragm and spermicide coated condoms. Keeping hydrated, urinating as soon as possible after sex, and avoiding synthetic underwear can help prevent UTIs in females. Other susceptible adults include the elderly and patients requiring urethral catheterisation.3 Urinary tract symptoms are not always obvious in the elderly. Presentation may be vague with incontinence, change in mental status or fatigue as the only symptoms, while some present with sepsis as the first symptoms. Diagnosis can be complicated by the fact that many elderly people have pre-existing incontinence or dementia. 5 Other risk factors for developing UTIs include conditions that prevents fully emptying the bladder, kidney stones, a weakened immune system, undergoing chemotherapy, diabetes, and an enlarged prostate gland in males.1 Symptoms of a lower urinary tract infection include dysuria, frequency, and the urge to urinate despite having an empty bladder. Symptoms may also include cloudy and unpleasant smelling urine, haematuria, abdominal pain, pelvic tenderness, back pain and a general sense of feeling unwell.1 Symptoms of a kidney infection include fever of 38ºC (100.4ºF) or above, shivering, nausea, vomiting, diarrhoea and flank pain. In addition frequency, dysuria, urgency and haematuria may also be present because the infection can spread from the kidneys to the lower urinary tract.1 The presence of bacteria in urine does not necessarily depict a urinary tract infection. Many people, especially the elderly, have bacteria in their urine without having any ill effects. This is known as asymptomatic bacteriuria. E. coli bacteria from the gut is the cause of 80–85% of community-acquired urinary tract infections, with Staphylococcus saprophyticus the cause in 5–10%. Occasionally they may be caused by viral or fungal infections.6 Healthcare-associated urinary tract infections mostly related to urinary catheterisation involve a much broader range of pathogens including: E. coli (27%), Klebsiella (11%), Pseudomonas (11%), Candida albicans (9%), and Enterococcus (7%) among others. Urinary tract infections due to Staphylococcus aureus typically occur secondary to blood-borne infections. Chlamydia

Theresa Lowry Lehnen CNS, GPN, RNP and PRO IPNA - Irish Practice Nurses Association

trachomatis and Mycoplasma genitalium can infect the urethra but not the bladder. These infections are usually classified as a urethritis rather than urinary tract infection.7 Diagnosis Urinalysis reagent strips are the most frequently used instruments for diagnostic testing if there is clinical evidence that a patient has a UTI. A high number of leucocytes in the urine points to the presence of white blood cells indicating inflammation or infection along the urinary tract, often in the bladder or kidney. The presence of nitrites in the urine is highly specific to certain bacterial infections but nitrites do not occur with all types of bacteria. E. coli bacteria are most commonly associated with nitrites in the urine. An infection may occur in the presence of leucocytes with no nitrites, however, leucocytes in the urine without nitrites can also lead to a false-positive result that points to a bacterial infection when there is none. Negative nitrite and negative leucocyte has a 95% negative predictive value. A positive nitrite test is more indicative than a positive leucocyte test, although the presence of both increase the possibility of a UTI diagnosis.16 For most woman who have the typical symptoms of a lower UTI, further testing is not usually required to confirm the diagnosis. Circumstances where laboratory testing is recommended are:1  All cases of UTI in men. UTIs are uncommon in men, so it is important to rule out other possible causes of the symptoms.  Cases of a suspected upper UTI. These infections have a higher risk of complications, so a careful assessment of the state of the urinary tract needs to be made.  UTIs that occur in pregnant women due to the higher risk of developing complications.  In cases where a person has blood in their urine. Although unlikely, this could be a symptom of bladder cancer so it is important to rule out or confirm the diagnosis.  In cases where a person has a risk factor that makes them more vulnerable to developing serious complications, such as having a weakened immune system. Other diagnostic tests required may include ultrasound, computerized tomography (CT) scan, magnetic resonance imaging (MRI) or cystoscopy. 8 Treatment: Adult Uncomplicated Uncomplicated UTI Treatment: Adult UTI(no (nofever feveror orflank flankpain) pain)8

Choice of empirical therapy should be governed by local resistance rates as patterns vary significantly across the country. For first Choice of empirical therapy be organisms governed in byuncomplicated local resistance rates as p presentations, with low risk ofshould resistant UTI, narrow-spectrum such fosfomycin, nitrofurantoin significantly across theantibiotics country. For firstaspresentations, with low risk of resistant or trimethoprim should be considered. For uncomplicated UTIs, uncomplicated UTI, narrow-spectrum antibiotics such as fosfomycin, nitro quinolones should be reserved for resistant infections with limited 8 trimethoprim should bebyconsidered. uncomplicated UTIs, quinolones should options and confirmed culture andFor sensitivity.

for resistant infections with limited options and confirmed by culture and sensit

Community multi-resistant E. coli with extended-spectrum betalactamase (ESBL) PHARMACYNEWSIRELAND.COM increasing so cultures should be carried out in all treatment failures. ESBLs are m but often remain sensitive to nitrofurantoin and fosfomycin. There is less



Choice of empirical therapy should be governed by local resistance rates as patterns vary significantly across the country. For first presentations, with low risk of resistant organisms in uncomplicated UTI, narrow-spectrum antibiotics such as fosfomycin, nitrofurantoin or trimethoprim should be considered. For uncomplicated UTIs, quinolones should be reserved for resistant infections with limited options and confirmed by culture and sensitivity. 8

Feature: UTIs

97

Community beingare present. Antibiotic therapy in these cases does not Communitymulti-resistant multi-resistantE.E.coli coliwith withextended-spectrum extended-spectrum betalactamasenecessarily (ESBL) enzymes reduce mortality or prevent symptomatic episodes, rather it increases betalactamase (ESBL) enzymes are increasing so cultures should be increasing so cultures should be carried out in all treatment failures. ESBLsside are effects multi-resistant and leads to antibiotic resistance. Empiric treatment may carried out in all treatment failures. ESBLs are multi-resistant but often but often remain sensitive to and nitrofurantoin fosfomycin. There isbeless relapse inwith considered a symptomatic patient with a positive dipstick. A urine remain sensitive to nitrofurantoin fosfomycin.and There is less relapse sample should bebe sent to the microbiology laboratory for culture and with trimethoprim than cephalosporins. preserve theefficacy efficacyofoffosfomycin, trimethoprim than cephalosporins. ToTo preserve the its use should antimicrobial susceptibility testing in these cases. Symptoms suggestive fosfomycin, its use should limited whereUTI possible to uncomplicated limited where possible to be uncomplicated in women, or in specific situations on advice of of a UTI include dysuria, frequency, urgency, new onset incontinence, UTI in women, or in specific situations on advice of an infection an infection specialist. Fosfomycin is not recommended for use in treatment of UTI in patients fever >38°C, suprapubic tenderness and haematuria. Diagnosis of UTIs specialist. Fosfomycin is not recommended for use in treatment of overin65 years in long facilities in specific situations on advice ofterm an infection in long care residents over 65 years should be based on a full UTI patients over 65term yearscare in long term except care facilities except in clinical specific situations on advice anavoided infectioninspecialist. Fosfomycin specialist. Fosfomycin shouldofbe the elderly and in patients with renalassessment. impairment In patients with a urinary catheter, loin pain and >38°C remains are significant indicators of a UTI.14 should avoided inurinary the elderly and in patients with renal impairment due to be diminished concentrations. Recommendation for use in fever pregnancy due to diminished urinary concentrations. Recommendation for use under review pending further evidence and safety data. 8 Empirical Treatment of UTI in Long Term Care in pregnancy remains under review pending further evidence and Residents > 65 years14 8 safety data. Empirical Treatment of of UTI UTI in in Long Long Term Term Care Care Residents Residents>>65 65years years1414 Empirical Treatment 9 Treatment (Acute Pyelonephritis)9 Empiric antibiotic therapy should only be considered in symptomatic Treatment (Acute Pyelonephritis) Empiric antibiotic therapy should only be be considered insymptomatic symptomatic patients pending urine Empiric antibiotic therapy should only considered in patients pending urine patients pending urine culture result. Choice of empirical therapy should culture result.by Choice ofresistance empirical therapy therapy should be guided guided by by local resistance resistance ratesand and culture result. Choice empirical be local rates be guided localof ratesshould and treatment modified according to treatment modified according to culture culture result resultwhen whenavailable. available. treatmentresult modified according to culture when available.

An MSU must be sent for culture. In acute Pyelonephritis, 7 days of An MSU with mustciprofloxacin be sent for culture. In as acute Pyelonephritis, 7 14 days of treatment with treatment is considered effective a treatment as Treatment ofResidents UTI in Residents a Urinary Catheter14 14 14 ciprofloxacin is considered as effective as within 14 days trimethoprim Empirical UTI in in Residents withaaUrinary Urinarywith Catheter days of trimethoprim (co-trimoxazole). If therea istreatment no response 24 of Empirical Treatment (coof UTI with Catheter 1, 9 hours the patient shouldisbe to hospital. If there noadmitted response within 24 hours the patient should be admitted to trimoxazole).

hospital. Paediatrics Treatment: 1, 9

Children less than 3 months old who present with UTIs will be referred Treatment: Paediatrics to a specialist and treated in hospital. Children over three months old, Children than 3 months who present with UTIs with a UTIless where there is a riskold of serious complications willwill alsobe bereferred to a specialist and of of therapy is usually 77 days. of the Duration days.7Delayed Delayed response regardless ofwhether whether thepatient patient Duration is usually days. response Delayedregardless response regardless of treated in Children overFor three months old, with aold UTI where is a(cefalexin risk oftherapy serious referred to hospital. hospitalisfor treatment. children over 3 years with a there or trimethoprim) usually commenced and for upper UTIs, a seven-day course ororusually remains catheterised not is IfIfan catheter has ininplace for not is 10-14 10-14 days. days. anindwelling indwelling catheter hasbeen been place formore more whether the patient remains catheterised or not is 10-14 days. If an low risk of complications, the infectiontocan be treated at home complications will also be referred hospital for treatment. Forpresent children over 3 years old co-amixoclav) is usually recommended. Positive nitrites mustusing be in the urine to at the onset UTI catheter should replaced. than 2 weekscatheter onset ofbeen UTI and and is still still indicated, indicated, the catheter shouldatbe be replaced. indwelling hasof in isplace for morethe than 2 weeks the ororal trimethoprim) is usually commenced andUTIs, for upper UTIs, acourse seven-day course (cefalexin or antibiotics, and paracetamol. For lower a three-day 11 prophylaxis is not the symptomatic UTI in Antibiotic not recommended recommended for the prevention prevention of with a low risk of complications, the infection can be treated at home using oral antibiotics, commence antibiotic therapy. onset of UTI and isisstill indicated, thefor catheter shouldofbesymptomatic replaced. UTI in of antibiotics (cefalexin, or trimethoprim) is usually co-amixoclav) is usually nitrofurantoin recommended. Positive nitrites must be present in the urine patients to or catheterised or for for urinary urinary catheter catheter changes changes unless unless there there isis aa definite definitehistory historyofof and paracetamol. For lower UTIs, a three-day course of antibiotics (cefalexin, nitrofurantoin Antibiotic prophylaxis is not recommended for the prevention of 11 a seven-day course (cefalexin or cocommenced and for upper UTIs, symptomatic UTIs due to to catheter catheter change. change. Antimicrobial Antimicrobial prophylaxis prophylaxis may may however however be be commence antibiotic therapy. 12 symptomatic UTI for in whom catheterised patients or for urinary catheter Treatment: UTI in WomenPositive amixoclav) isRecurrent usually recommended. nitrites must be present in considered in patients for whom urinary urinaryinfections infectionsare areof ofsuch suchfrequency frequencyor orseverity severitythat thatthey they changes unlesson there is aand definite history of symptomatic UTIs due to 14 14 function well-being. the urine to commence antibiotic therapy.11 chronically impinge function and well-being. catheter change. Antimicrobial prophylaxis may however be considered Treatment: Recurrent UTI in Women 12 12 Although UTIs are often considered to be easily managed they an considered be easily managed infections, theyremain remainor aneconomic economic Treatment: Recurrent UTI in Women in patients for whom urinarytoinfections are ofinfections, such frequency burden forthat the healthcare system. 2014 annual estimated care 14 were healthcare system. In Inimpinge 2014 the the on annual estimated primary carecosts costs were severity they chronically function andprimary well-being. €19.2 million compared to the low annual cost of UTIs ininsecondary care approximately million compared to the low annual cost of UTIs secondary careatat Although UTIs are often considered to be easily managed infections, €155,000. Health were estimated on basis consultation approximately Health care care costs costsfor were onthe thesystem. basisof ofGP GP they remain €155,000. an economic burden theestimated healthcare In consultation 2014 costs, antibiotic costs, laboratory laboratory costs costs and and secondary secondary inpatient inpatient and and outpatient outpatientcosts. costs.The The the annual estimated primary care costs were approximately ¤19.2 15 latter was latter was acquired acquired from from national national clinical clinical data data on on discharges dischargesininacute acutehospitals. hospitals. 15Suspected Suspected million compared to the low annual cost of UTIs in secondary care UTIs are UTIs are aa common common reason reason to to attend attend primary primarycare careservices servicesininIreland. Ireland.From Fromthe thehealth healthservice service at approximately ¤155,000.cost HealthUTIs care costsdriven were estimated on thewith perspective, the perspective, the overall overall economic economic cost of of UTIs isis mainly mainly driven by by primary primarycare carecosts costs with 15antibiotic costs, laboratory costs and basis of GPlow consultation costs, comparatively secondary comparatively lowcan secondary care care costs. costs.15 If more than 3 UTIs occur per year, continuous or post-coital prophylaxis with antibiotics secondary inpatient and outpatient costs. The latter was acquired from 15 Ifbe more than 3inUTIs occurHowever, per year,both continuous or post-coital effective women. are associated with antibiotic side effects. There is no national clinical data on discharges in acute hospitals. Suspected The increasing prevalence of resistance among uropathogens presents The increasing prevalence of antibiotic antibiotic resistance among uropathogens presentsaamajor major 12 antibiotics beare effective in women. However, both evidence standby antibiotics effective. UTIs areto common reason to attend care services Ireland.are challenge clinical of Although situations Ifprophylaxis more thanthat 3with UTIs occur percan year, continuous or post-coital prophylaxis with antibiotics can management challenge toa the the clinical management of UTIs. UTIs. primary Although in in most most situationsinantibiotics antibiotics are are associated with antibiotic side effects. There is no evidence that required, inappropriate treatment contributes the of resistance From the health service perspective, overall economic cost of required, inappropriate treatment contributesto tothe thegrowing growingproblem problem ofantibiotic antibiotic resistance bestandby effective in women. However, 12 both are associated with antibiotic side effects. There is no antibiotics are effective. in UTIs. empirical of tract infections (UTIs) 13 UTIs mainly driven by treatment primary costs with comparatively low for in UTIs.isAppropriate Appropriate empirical treatmentcare of urinary urinary tract infections (UTIs)isisimportant important for Treatment: in Pregnancy evidence thatUTI standby antibiotics are effective. 12 15 successful treatment and of However, with secondary care costs. The increasing prevalence of antibiotic successful treatment and prevention prevention of complications. complications. However, with the the increasing increasing Treatment: UTI in Pregnancy13 prevalence of urinary of empirical resistance among uropathogens presentsthe a selection major challenge to the prevalence of antibiotic-resistant antibiotic-resistant urinarypathogens, pathogens, the selection ofan anappropriate appropriate empirical clinical management of UTIs. Although in most situations antibiotics are Treatment: UTI in Pregnancy 13 required, inappropriate treatment contributes to the growing problem of antibiotic resistance in UTIs. Appropriate empirical treatment of urinary tract infections (UTIs) is important for successful treatment and prevention of complications. However, with the increasing prevalence of antibiotic-resistant urinary pathogens, the selection of an appropriate empirical agent is increasingly difficult.17 Resistance to co-trimoxazole and other antimicrobials used in the treatment of UTIs, particularly For UTIs in pregnancy an MSU must be sent for culture and any fluoroquinolones, For UTIs in pregnancy an MSUwhen mustresults be sentoffor and anyand empirical treatment reviewed is increasing, as is the prevalence of extendedempirical treatment reviewed theculture MSU culture spectrum-beta-lactamase (ESBL) producing Enterobacteriaceae and susceptibility is common and when resultsare of available. the MSU Amoxicillin culture andresistance susceptibility are available. Amoxicillin resistance is multidrug-resistant (MDR) Pseudomonas aeruginosa. The problem is should be used only if susceptibility data is available. Nitrofurantion common and should be used only if susceptibility data is available. Nitrofurantion should be particularly prominent in the hospital setting, where UTIs can present For UTIs be inafter pregnancy an MSU mustgestation be sent forrisk culture any empirical treatment reviewed should avoided after weeks to the and risk of neonatal avoided 36 weeks36 gestation due to thedue of neonatal haemolysis. Fosfomycin use in and MDR organisms are frequent.17 Understanding as severe infections haemolysis. Fosfomycin use in pregnancy remains under review when results of the MSU culture and susceptibility are available. Amoxicillin resistance is 13 pregnancy remains underand review pending and safety data.the key criteria for antibiotic selection, pathology of UTI and therapeutic pending further evidence safety data.13further evidence common and should be used only if susceptibility data is available. Nitrofurantion be prescribed agents is vital for practitioners to ensure profile ofshould commonly Diagnosis & Management Management of UTI UTIdue inLong Long Term Care safeuse andin cost-effective treatment. Judicious use of antibiotics 14rational, avoided after 36 weeks gestation to the risk of neonatal haemolysis. Fosfomycin Diagnosis & of in Term Care Residents > 65 years 14 Residentsremains > 65 years pregnancy under review pending further evidence and safety data.in13common clinical situations is crucial for minimising antibiotic resistance and the effective treatment of patients. AApositive positiveurinalysis urinalysisreagent reagentstrip strip(dipstick) (dipstick)result resultininananasymptomatic asymptomatic patient should not be 14 patient not be Residents inTerm longhave term high care rates facilities Article was previously published in the Medical Independent. Diagnosis & Management UTI in Long Care Residents > 65 years dipstick treated.should Residents in treated. longofterm care facilities of positive urinalysis References on request have high rates of positive dipstick urinalysis results without infection

results without infection necessarily being present. Antibiotic therapy in these cases does not A positive urinalysisorreagent (dipstick)episodes, result inrather an asymptomatic patient should not be reduce mortality preventstrip symptomatic it increases side effects and leads treated. Residents in longEmpiric term care facilities high ratesinofa positive dipstick urinalysis to antibiotic resistance. treatment mayhave be considered symptomatic patient with results without infection necessarily being present. Antibiotic therapy in these cases not a positive dipstick. A urine sample should be sent to the microbiology laboratory for does culture and antimicrobial testing in episodes, these cases. Symptoms suggestive of a UTIand include reduce mortality orsusceptibility prevent symptomatic rather it increases side effects leads dysuria, frequency, urgency, new onset incontinence, fever >38°C, suprapubic tenderness and

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98

Finance

Protection Policies - Company Paid v Personally Paid Without doubt one of the most important findings that come from our financial reviews relate to poorly explained advice clients received in regard to having their business pay for life cover. If you have been advised to take out life cover through your company as either pension term cover or executive term cover its important to be aware of the implications of these actions. The balance of €600,000 must be used to buy an annuity also known as ‘income for life’. Annuity levels The balance of ¤600,000 must taxation on extraction. Again this are determined primarily by agebeand ‘A Rated markets which are Written by Kieran Moore, QFA, SIA, usedprevailing to buy an annuity also Government is an areaBond’ that clients we reviewed Moore Wealth Management ‘income for for life’.aAnnuity unaware of and was not currently at all-time lows. A quote known run in as March 2021 male age were 50 comes back at 2.2% per annum levels are determined primarily made clear to them by the financial so your family get a taxable income of €13,572 per annum instead of the anticipated large tax free by age and prevailing ‘A Rated adviser. The focus was on the sale The maximum life cover you can compared lump sum. The perception to theBond’ reality of what aretheinsured for is vast and Government markets which youand hook of being tax efficient. the have is four times your salary, are currently at all-time lows. A The simple rule with life cover implications areforhuge. plus allowances a spouse, or quote run in March 2021 for a male

is that if you want the full lump registered civil partner’s pension. age 50 comes back at 2.2% per sum paid to your family on death Company Life Cover This limit onPaid life cover includes the annum so your family get a taxable without tax implications you need value of your main pension from income of ¤13,572 per annum to pay for the cover personally out employer contributions and any Your business can insure you to protect the large impact of you dying business paying insteaditself of theagainst anticipated of your ownwith bankthe account. life cover you have through your tax freeissues lump sum. The perception the premiums. Here we also encounter as business owners are told to be tax efficient and have Company Paid Income pension. compared to the reality of what Protection the company pay the premium. But you for need to understand is that if the company pays the you what are insured is vast and the Lets break this down, revenue are huge. premium in thethe event of claim theimplications policy proceeds are paid into theIncome business and not directly Protection is the most to your legislation limits amount of

It is true to say most readers will have had the experience of being “sold” insurance at some point with often the only motivation being commission for a third party. This can be off putting but it should not turn you away from these products entirely. When put in place properly and with a defined purpose it can be argued they are one of the most transparent financial products available. They are very specific and typically don’t rely on investment returns which can be unpredictable. In short most do exactly what they say on the tin, if you pay your premiums the policy will pay a defined lump sum to you or your dependents In the event of a claim. However understanding what happens when the policy is paid for by your company is overlooked and misunderstood. The life company technical teams will attest to the issues arising where the estates of deceased policy holders think they have a fixed amount of cover when the reality is vastly different. Company Paid Pension Term Cover Also known as executive pension term cover this is sold to business owners as a tax efficient way to pay for your life cover. The sales person will ask why you are paying for life cover out of your after tax income when the business can pay for it. So far so good. However the problem lies in the amount of cover that business owners are sold. Here is what the revenue commissioners legislation states

important you can andthan the cover that can paidof tocover is suitable Companyfor Paid Life Cover protection dependents. Thisbetype shareholder where acover business hashave more this policy can and should be paid your family/estate to 4 times your Your to business can shares insure you to a buy one owner and the proceeds buy back under agreement. But to it is not by and yoursell company. Your ability salary and this includes the valueare used itself against the impact earn is your biggest asset and of any employer benefitsis for protect suitable wherepension the intention the proceeds to go directly to your family as they will have to extract of you dying with the business a direct culmination of years of you have. This means that many the funds from the company and pay the same taxes as drawing salary. This more than cancels paying the premiums. Here we study, hard work and enterprise out people are paying for a cover also encounter issues as business on your If you no longer they think will be going to their the perceived benefit of having the business pay the premium to save tax part. as you arecan losing over 50% owners are told to be tax efficient work all this is taken away from dependents as a cash lump sum in taxation on extraction. Again this is an area that clients we reviewed were unaware of and was and have the company pay the you. This a benefit that pays up to not and the reality is fundamentally premium. But what need to on the 75% of your if you different. The to worked made clear themexample by the financial adviser. The you focus was sale and income the hook ofcannot being tax understand is that if the company work after a deferred period below is typical of what we see efficient. The simple rule with lifepays cover that if inyou lump sum paid to your family on the is premium thewant event the fulltypically 13-26 weeks. The benefit Executive Pension claimto the policy death without tax implications youofneed pay for proceeds the cover personally out ofifyour own bank account. is payable you cannot perform Term Cover

¤750,000

are paid into the business and

your duties as a pharmacist. It

family as they will have to extract

protect your companies pension

directly to your dependents. does not matter if you work and Company Protectionnot – Income Protection is the most important cover youcould can have Salary Paid Income ¤100,000 This type of cover is suitable for elsewhere, its specific to your this policy can and should be paid by your company. Your ability to earn is your biggest asset and a shareholder protection where Pension Value ¤250,000 occupation. a business has more than one direct culmination hard work and enterprise on your part. If you can no longer work In this case on death of youyears mightof study, The premium on this qualifies for owner and the proceeds are used assume estateaway will get ¤1 you. This all this isthetaken from a benefit that pays to 75% of your income if you cannot corporation tax relief if paid for work to buy back shares underup a buy million in cash made up of the life the business. A big advantage and sell agreement. But it isisnot after a deferred period typically 13-26 weeks. The benefit payableby if you cannot perform your duties cover amount and the pension. of having this policy paid through suitable where the intention is for as a pharmacist. It does not mattertheif proceeds you could elsewhere, specific to your occupation. However applying the revenue company is that you can also to work go directly to your its your rules the lump sum that reaches

the surviving estate/family is on yourAbehalf while funds fromtax the relief company and for bypremiums The premium on this qualifies for the corporation if paid the business. big advantage of calculated as four times current out of work. So with this policy pay the same taxes as drawing having this policy paid through your company is that you can also protect your companies pension salary including the value of you are protecting your potential salary. This more than cancels out your pensionon which only up to your retirement age lost premiums yourmeans behalf while out work. Sobenefit with of this policy areincome protecting potential theofperceived having theyoulost ¤400,000 is actually paid out as a and you will also have your post business pay the premium to save income up to retirement age and you will also have your post retirement income protected. retirement income protected. tax free lump sum. tax as you are losing over 50% in

Guide to paying for Life Cover for business owners Guide to paying Life Cover for business owners Family Protection cover Pension Term cover Income Protection cover Serious illness cover

Personally Paid The full amount goes to your family tax free

Company Paid Proceeds taxed on extraction from the company

Only up to appropriate level. Caution needed so you don’t pay for cover you won’t receive No pension premium cover available

Only up to appropriate level. Caution needed so you don’t pay for cover you won’t receive Can also include cover for your pension payments

If you wish to receive the lump sum personally

If you want the funds to protect the business

If you have any queries on this or feel you would benefit from having this reviewed please feel free to get in touch. Kieran Moore QFA SIA of Moore Wealth Management is advising members of the pharmacy community Ifforyou any and queries oncontacted this or feel you would benefit from having reviewed please feel free overhave 20 years can be via www.mwm.ie kieran@mwm.ie or onthis 086-3801868

to get in touch. Kieran Moore QFA SIA of Moore Wealth Management is advising members of the

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€16,000,000,000,000

TRILLION

That’s what it cost to get stock markets back off the ground in 2020. While the world dealt with an unprecedented crisis, stock markets rose. This is the main reason portfolios increased in value last year. This level of intervention is not sustainable and this accumulated risk has rolled into 2021.

Get in touch with Kieran or Colm for a FREE and confidential pension review. www.mwm.ie colm@mwm.ie

086 860 39 53

|

kieran@mwm.ie

086 380 18 68

Moore Wealth Management Limited trading as Moore Wealth Management is Regulated by the Central Bank of Ireland Reg number 55195


100

News

Increased Resources Needed for Obesity On World Obesity Day, a leading bariatric surgeon has called on the Department of Health and the HSE to commit increased resources to tackling obesity. The call comes after data published by the CSO revealed that more than four in 10 people said their consumption of junk food and sweets had increased since the start of the Covid-19 crisis. Dr John Conneely, Consultant Surgeon, Mater Private Network

Dr John Conneely, a Consultant Surgeon at the Mater Private Network, specialising in weight loss management and bariatric surgery, warned that Covid-19 is likely to increase the incidence of obesity in Ireland. Dr Conneely has urged the Department of Health and HSE to urgently address the challenges which patients suffering from Obesity experience when trying to access weight loss or management services. Over 60% of Ireland's adult population is overweight, with 23% classified as obese.

Bariatric surgery can significantly improve a number of serious health conditions and diseases, such as Type 2 diabetes, high blood pressure, infertility, cardiovascular disease, asthma or sleep-apnea. Research published last year also found that bariatric surgery can free 67% of patients with Type 2 diabetes from the use of insulin. The research also found that this surgery is more effective and cheaper than medical therapy for diabetes. Commenting on World Obesity Day, Dr Conneely noted, "Patients suffering from obesity have long struggled to access health services to help them lose or maintain weight loss but the interruptions to health services during Covid-19 has made an already poor situation much, much worse. “For many people who are suffering from obesity, the

stress, uncertainty, and repeated lockdowns have exacerbated their condition, similarly to all those with chronic conditions. “For those with chronic obesity waiting for bariatric surgery, waiting lists have grown and their condition has worsened. “We have incontrovertible evidence from global experience that bariatric surgery can be transformative for patients and prevent or reduce the incidence of other conditions such as diabetes or heart disease, making them also more cost effective for our health services. “As we begin to emerge from Covid-19 our health services now must plan and adequately resource the services patients suffering from Obesity need to quickly access supports to achieve and maintain a healthy weight.”

Advertorial You can Grow Old - Without Losing your Memory One of the downsides of old age is the loss of cognitive functions such as memory and concentration. The good news is that there are natural ways to pull the brake on the process. One of the better documented methods is supplementation with a plant extract called ginkgo biloba. Certain functions slow down when age creeps up on us. One of the things that many seniors are familiar with, and which is often a target for jokes, is the gradual loss of memory. This is certainly no laughing matter and problems with recollecting can be quite upsetting for those who suffer and for those around them. A bit of good news is that nature is abundant with useful resources for slowing down the advent of such health issues, and one of the things that has caught the attention of science is ginkgo biloba. The brain needs a lot of oxygen Ginkgo biloba is a plant extract known by researchers worldwide for its unique ability to dilate blood vessels and help more blood reach remote tissues such as the brain. Our brain accounts for around 20-25 percent of our total oxygen consumption, so you can imagine how important it is to

have a sufficient flow of blood to the head and through the intricate network of capillaries in the brain. Scientists have seen how ginkgo biloba increases the electric activity in the brain of older people, lowers blood viscosity, and reduces platelet aggregation, which means that the blood platelets become less sticky. Study of ginkgo biloba extract A recent study1 showed that daily supplementation with a high-quality gingko biloba supplement significantly improved cognitive decline in ageing men and women. The study included 500 patients with mild cognitive impairment (MCI) who were treated with 120 mg per day of standardized ginkgo biloba extract. Being standardized means that the extract always contains the exact same amount of active compound and that is crucial for the outcome of studies like these.

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Significant improvement seen The scientists evaluated the patients using different scales for assessment of cognition, memory, activities of daily living, and depression and found that ginkgo biloba worked as expected. After 24 months of treatment and with regular follow-up, more than 80 percent of the participants had shown some degree of improvement. The researchers concluded that administration of ginkgo biloba significantly improved cognitive decline, memory, activities of daily living, and depression in patients with MCI. May even help against Alzheimer’s disease This is certainly not the only study pointing to ginkgo biloba and its positive impact on cognitive function. A recent Chinese meta-analysis2 (thorough review of multiple studies) of seven published studies deemed ginkgo

biloba a reliable and effective treatment for people suffering from Alzheimer’s disease. The meta-analysis is published in Clinical Neuropharmacology. While normal age-related cognitive impairment and Alzheimer’s disease are two entirely different problems, it still interesting to see that a natural plant extract can make a difference. Besides ginkgo biloba’s ability to dilate blood vessels, the main active ingredients in the extract – the so-called ginkgoflavonglycosides and terpene lactones – are also powerful antioxidants that protect brain cells. Sources: Effectiveness and Safety Profile of Ginkgo Biloba Standardized Extract (EGb761®) in Patients with Amnestic Mild Cognitive Impairment.

1

Băjenaru O; Prada G; Antochi F; Jianu C; Tudose C; Cuciureanu A; Docu AA; Perrot V; Avram M; Tiu C CNS & Neurological Disorders Drug Targets, 08 Feb 2021, DOI: 10.2174/1871527320666210208125524


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102

Educational

¤7.45m Project for Osteoarthritis April 20th-24th marked National Arthritis Week NUI Galway’s Regenerative Medicine Institute has launched a new €7.45 million project to develop groundbreaking and innovative scientific and engineering platforms for the production of advanced cellular therapeutics for use in the treatment of osteoarthritis and other major diseases. for automated, robot-enabled manufacturing of the cell products to ensure that patients will benefit in the foreseeable future.” According to Frank Barry, Professor of Cellular Therapy at REMEDI, the adoption of best in class manufacturing protocols is still the most serious obstacle facing the cell therapy industry: “We know from our experience in managing cell therapy clinical trials that the manufacturing side is inefficient and vulnerable with an unacceptably high cost of goods. The only way the field can progress is through the widespread adoption of highly automated production and testing protocols. AutoCRAT addresses these gaps and will be a game-changing innovation.” Other essential contributions will come from: Funded by the EU Horizon 2020 programme the AutoCRAT project will address the critical need to develop industrially relevant, cost effective and fully automated manufacturing systems for this new area of medical treatment. Based on a strong interdisciplinary and collaborative effort, it will generate a deeper understanding of the science of stem cells and their therapeutic use as well as harnessing world-class expertise in advanced engineering and robotic systems. The project will also meet the need for development of an effective treatment for osteoarthritis and the demand for other cell-based treatments by transforming the way stem cells and their secreted therapeutic factors (mainly a novel type of biological nanoparticles, the so called extracellular vesicles (EVs)), are manufactured. Cellular therapies are being tested for a wide range of conditions including degenerative diseases, immune and inflammatory disorders and cancer. These revolutionary therapies offer great promise for patients and practitioners and may finally open the door to new and effective treatments which up to now have been unavailable. Several different types of cells may be used, (including stem cells, tissuederived adult cells and cells of the immune system) depending on the specific treatment. The use of living cells as a medicinal

product presents extraordinary challenges in terms of production and current manufacturing protocols are relatively inefficient and limited in scale. They also require highly-skilled teams of technicians operating in a cleanroom environment. As clinical trials progress and more treatments are available for patients, cost-efficient and high throughput manufacturing remains a major challenge. The AutoCRAT Regenerative Medicine Factory (ARM-F) will produce chondrocytes and stem cells for arthritis treatments using robots for every manufacturing step. It will also generate products based on proteins, RNA and other materials that stem cells produce and which are now understood to be key elements of their therapeutic mechanism. Thus, AutoCRAT will enable the production of cellbased therapeutics on an industrial scale, that is more controlled and at a lower cost compared to existing technology. This will accelerate the development of the cell therapy industry and make these treatments more accessible for the benefit of patients.

 Valitacell Ltd (VC), based in Dublin will establish automated quality control tests for the automated factory.

The AutoCRAT project will be led by Mary Murphy, Professor of Regenerative Medicine and a Principal Investigator at the Regenerative Medicine Institute (REMEDI) at NUI Galway. Professor Murphy said, “This is an exciting interdisciplinary project that will develop new cell therapies for arthritis and provide the platform

The project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 874671. The material presented and views expressed here are the responsibility of the author (s) only. The EU Commission takes no responsibility for any use made of the information set out.

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 The University of Gothenberg and Leiden University Medical Center will work with REMEDI to develop and test these new arthritis therapies.  Essen University Hospital and the University of Genoa will develop methods to produce EV-containing, cell-free therapeutic products for arthritis in the automated system.  Panaxea BV will determine the costs of production and delivery of the developed therapies. They will also assess the potential benefits of an effective cell therapy for osteoarthritis to patients and their families as well as the broader European and worldwide economies.  Pintail Ltd will assist with the management and administration of the Project and will ensure that AutoCRAT output is disseminated effectively to our target audience

Arthritis Survey A nationwide survey has been launched which aims to identify the impact of the Covid-19 pandemic on people living with arthritis. The survey is being conducted by Arthritis Ireland, the national patient organisation and health research charity. This is the second such survey undertaken by the organisation. The charity is asking anyone living with arthritis to complete the online survey. It says the more people that participate in the research, the more accurate a picture it will have of the impact of Covid-19. The survey looks to identify how the pandemic has affected people’s capacity to access health services, attitudes towards the vaccines, as well as its impact on physical and mental health. According to Brian Lynch, head of communications and advocacy at Arthritis Ireland, “Our 2020 survey showed that four in ten people with inflammatory arthritis had a hospital appointment to see their consultant cancelled or postponed during the first phase of the pandemic. One-third had scans, blood tests or other tests cancelled or postponed. “These are significant findings, because arthritis is a chronic condition for which there is no cure. If people cannot access the health services they need, there is increased risk of longterm damage to their health. “The findings from this new survey will give us the data to advocate on behalf of the one million people living with arthritis. This is a destructive disease that causes enormous pain to people. Arthritis doesn’t stop while we’re trying to solve the pandemic,” Lynch said. This is an anonymous survey. Respondents will not be asked for any personal information in the survey that would identify them and the data will be stored securely.


Addictions

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Has Covid effected Alcohol Consumption in Ireland? Ireland continues to hold a profoundly difficult relationship with alcohol use. As a nation, we blindly dismiss the impact of alcohol on our health and the wellbeing of others. Today, over seven people will die because of alcohol, and annually, it is estimated that over 2,700 people will be lost to alcohol related illness and incident; a pandemic toll every year! Alcohol related inpatient healthcare accounts for 11% (approx. €1.8 billion) of all public healthcare expenditure. In 2020, our collision with a global pandemic has done little to quell our insatiable craving for alcohol. In normal times, one third of all alcohol use is purchased in the off-trade licenced premises (pubs, clubs, restaurants) however despite that market largely being closed for much of the year, alcohol use only fell by as little as 6%. Wine sales have rocketed with 138 million bottles being consumed while spirit sales saw no change in volume. This dramatic shift in Ireland’s alcohol use has seen an ocean of alcohol poured into our homes; temporary lifestyles may well have become permanent habits, while the 200,000 children, who already silently faced the chaos of parental problem alcohol use, have tried to navigate COVID, cut off from their normal supports, with even greater hardship. During the first wave of the pandemic as alcohol was quickly identified as the lubricant to irresponsible behaviour and a constant within the virus transmission, Government chose to copper-fasten the risk by designating off-trade sales as somehow ‘essential’. As the Chief Medical Officer, Dr Holohan, put it: “let’s be honest here, we have a challenge in this country, it is really difficult for us all to maintain public health guidance when it's mixed in with the use of alcohol. The virus loves indoor settings, it loves close contact between people, and it loves alcohol.” Available legislative measures such as minimum pricing for alcohol products that would have stopped reckless price discounting were ignored and proposals to restrict availability and volume were dismissed. Meantime, as the value of intensive care units became the currency of our time, one in five beds continued to manage the struggles of those suffering the most acute alcohol use disorders. So, why do we drink so much, and so harmfully? Well, the popular

Written by Eunan McKinney, Head of Communications and Advocacy, Alcohol Action Ireland

myth usually revolves around some fabrication of cultural mark. However, the principal reason is the vast effort that is undertaken to market the product, in all its guises: price, placement, product and promotion. Annually, it is estimated that the alcohol producers spend over ¤115m annually on alcohol advertising, with digital presence increasingly important to sustaining new entrants. Price, without the implementation of minimum pricing, continues to be discounted ensuring exceptional affordability in the off-trade, where two thirds of all alcohol is purchased. This ruthless commercial practice guarantees that over 80% of the adult population drink, with 54% of those drinking harmfully. This unfettered market access also ensures 40% of all 15 years old are already drinking, and by the time they enter early adulthood, 93% are recruited to supporting the alcohol industry with a ‘lifetime of income’ and are committed members of the EU’s No.1 binge drinkers. In any public discussion of alcohol misuse, the focus inevitably turns to those who are dependent. However, as a nation, we must understand that our societal difficulty with alcohol lies in those who simply drink too much. In Ireland, alcohol use for 2019 was 10.78 litres per person (>15 years), which corresponds to 41 (700 ml) bottles of vodka, 115 (750 ml) bottles of wine or 441 pints of beer. And 40% beyond the low-risk drinking guidelines. It is little wonder that Dr John Ryan, Consultant Hepatologist at Beaumont Hospital reports “in the past 40 years the mortality rate, deaths from advanced liver

disease – alcohol-related liver disease predominantly – has increased 400%”. By the late 1980s, preventative health clearly understood the tremendous risk to public health from continued tobacco use, and while it took significant political commitment and courage, vested interests were side lined and meaningful action on controls and regulation were taken. There was no great appeal to acting ‘responsibly’ but instead tobacco prices were increased; placement was removed; products were accurately labelled identifying the risk, and promotion was banned. Smoking prevalence among adults has essentially halved over this time from 33% to 17%, saving thousands of lives as a consequence. The Public Health Alcohol Act, 2018, contains a suite of measures

designed to reduce alcohol use and protect children from early initiation. And while some measures such as restrictions on placement, have been introduced the central measures on price, product information and promotion have yet to be commenced. The principal objective of the legislation, which was obstructed at every opportunity by the alcohol producers and retailers, is to reduce alcohol use by 20% over 7 years. This, were it achieved, would undoubtedly improve the health of the nation and begin to address our careless loss of human creativity, enterprise and potential. The Alcohol Action Ireland podcast series 'The Alcohol File' is available at https:// alcoholireland.ie/about/thealcohol-file/ or from wherever you get your podcasts.

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Clinical R&D

VIIV HEALTHCARE RECEIVES MARKETING AUTHORISATION FOR RUKOBIA

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, announced the European Marketing Authorisation of Rukobia (fostemsavir) 600mg extended-release tablets, for use in combination with other antiretroviral (ARV) therapies for the treatment of adults with multidrugresistant HIV-1 infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen.1 Fostemsavir is a firstin-class HIV attachment inhibitor; it works by targeting the first step of the HIV lifecycle and shows no cross-resistance to other currently licensed antiretroviral classes, offering a new option to this group of people who are multidrugresistant and at risk of disease progression and death. Professor Carlo Federico Perno, Director, Microbiology and Diagnostic Immunology, Pediatric Hospital Bambino Gesu', Rome said: “We’ve seen significantly improved HIV treatments becoming available over the past few decades, making HIV a manageable life-long condition. However, for some people who are living with multidrug-resistant HIV, there is an urgent need for new treatment options. In clinical trials, fostemsavir, in combination with other antiretroviral therapies, demonstrated sustained rates of virologic suppression and clinically meaningful CD4+ T-cell recovery offering us a long-awaited new option for this specific HIV community.” The Marketing Authorisation Application (MAA) for fostemsavir is supported by data from the pivotal phase III BRIGHTE study, which

evaluated the safety and efficacy of fostemsavir in combination with an optimised background therapy (OBT) in heavily treatment experienced (HTE) adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry. In the randomised cohort, 60% (n=163/272) of individuals who received fostemsavir in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically significant improvements to CD4+ T-cell count through Week 96.2 Deborah Waterhouse, CEO of ViiV Healthcare, said: “There have been great strides forward in the treatment of HIV over the last few decades, however, there still remains a small subset of people living with multi-drug resistant HIV who are at risk of having their disease progress. The Marketing Authorisation for fostemsavir marks a significant milestone, as it addresses a critical unmet need in HIV care for those with little or no treatment options left. At ViiV Healthcare, through our pioneering research and development, we aim to meet the diverse needs of the HIV community. We won’t stop until our research offers more ways to treat, and hopefully one day, cure HIV.” The most commonly seen treatment emergent adverse reactions were diarrhoea (24%), headache (17%), nausea (15%), rash (12%), abdominal pain (12%), and vomiting (11%). The most common adverse events leading to discontinuation were related to infections (3%). The most serious adverse reaction was immune reconstitution inflammatory syndrome.1 Fostemsavir, under the brand name Rukobia, was licensed by the US Food and Drug Administration on 2 July 2020, and further

regulatory applications have been submitted worldwide. As the only pharmaceutical company solely focused on HIV and AIDS, ViiV Healthcare is working to deliver a broad range of treatments that meet the needs of a wide variety of people living with HIV (PLHIV). The company continues to invest in R&D programmes that push the boundaries to provide a portfolio of innovative treatment options that will help make a difference to the lives of PLHIV. References 1 European Medicines Agency. Rukobia SmPC. 2 Lataillade, M., et al. 2020. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. The Lancet, Vol 7 Nov 2020 pp.740-751.

 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Trade marks are owned by or licensed to the ViiV Healthcare group of companies. Date of Preparation: February 2021 PM-IE-FST-PRSR-210001

EMA RECOMMENDS COVID-19 VACCINE The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Janssen to prevent COVID-19 in people from 18 years of age. This is the fourth vaccine recommended in the EU for preventing COVID-19. After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the criteria

MAXILIEF EFFERVESCENT TABLETS; PACK SIZE CHANGE Clonmel Healthcare wishes to inform you that the dispensing pack of Maxilief Effervescent Tablets is moving from a 60 pack to a pack size of 100. Maxilief Effervescent Tablets (Paracetamol 500mg, Codeine Phosphate Hemihydrate 8mg and Caffeine 30mg) are indicated for the management of symptoms of headache, including migraine, musculoskeletal pain, toothache, backache, common cold, influenza and menstrual pain. Full prescribing information is available on request or alternatively please go to www.clonmelhealth.ie. The 100 pack size is subject to medical prescription. Please contact Clonmel Healthcare on 01-6204000 if you require any additional information. PA 0126/113/001. PA Holder: Clonmel Healthcare Ltd., Clonmel, Co. Tipperary. Date prepared: January 2021. 2020/ADV/MAX/085H.

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for efficacy, safety and quality. COVID-19 Vaccine Janssen is the fourth vaccine recommended in the EU for preventing COVID-19. “With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” said Emer Cooke, EMA’s Executive Director, adding, “this is the first vaccine which can be used as a single dose”. Results from a clinical trial involving people in the United States, South Africa and Latin American countries found that COVID-19 Vaccine Janssen was effective at preventing COVID-19 in people from 18 years of age. This study involved over 44,000 people. Half received a single dose of the vaccine and half were given placebo (a dummy injection). People did not know if they had been given COVID-19 Vaccine Janssen or placebo. The trial found a 67% reduction in the number of symptomatic COVID-19 cases after 2 weeks in people who received COVID-19 Vaccine Janssen (116 cases out of 19,630 people) compared with people given placebo (348 of 19,691 people). This means that the vaccine had a 67% efficacy. The side effects with COVID-19 Vaccine Janssen in the study were usually mild or moderate and cleared within a couple of days after vaccination. The most common ones were pain at the injection site, headache, tiredness, muscle pain and nausea. The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.


105 STERIGENICS ANNOUNCES EXPANSION OF RANTIGNY FACILITY TO INCREASE EUROPEAN STERILIZATION CAPACITY Sterigenics S.A.S., a subsidiary of Sotera Health and a global leader in comprehensive sterilization services, announces the expansion of its ethylene oxide (EO) facility located in Rantigny, France to increase European sterilization capacity. The expansion increases the Rantigny facility's total sterilization throughput and diversifies its capabilities with the addition of a 32-pallet chamber. "Local and regional demand for contract sterilization services has been increasing to meet healthcare needs," said Pontus Rundstrom, Vice President, Operations EMEAA. "The additional capacity at Rantigny shows our commitment to our sterilization customers by helping to get their products into the market in a fast, flexible and reliable way." Sterigenics remains committed to addressing the growing need for sterilization in many parts of the world. The Sterigenics' Rantigny facility provides routine EO, EOStat® rapid processing, cycle development and process validation and offers laboratory testing services through its co-located Nelson Labs facility. The Rantigny expansion follows Sterigenics' recent acquisition of Iotron Industries, a leading electron beam provider in North America. The acquisition further expands the company's capacity across multiple technologies throughout its global network. About Sotera Health: Sotera Health Company is a leading global provider of mission-critical endto-end sterilization solutions and lab testing and advisory services for the healthcare industry. Sotera Health goes to market through three businesses – Sterigenics®, Nordion® and Nelson Labs®. Sotera Health is committed to its mission, Safeguarding Global Health®. About Sterigenics: Sterigenics is a leading global provider of

outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. With our industry recognized scientific and technological expertise we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 48 facilities worldwide, we offer our customers a complete range of outsourced terminal sterilization services, primarily using the three major sterilization technologies: gamma irradiation, ethylene oxide processing and electron beam irradiation and expert advisory services. We are committed to addressing the growing need for sterilization in many parts of the world and partnering with our customers to eliminate threats to human health. Safeguarding Global Health® - with every product we sterilize. SECURE ACCESS TO COVID-19 DATA RESEARCH HUB Minister for Health Stephen Donnelly, TD, has launched an initiative to facilitate safe and secure access to COVID-19 data for valid health research purposes. The Central Statistics Office (CSO) has been maintaining a COVID-19 Data Research Hub since April 2020. To date this data has been used solely by a sub-group* of the National Public Health Emergency Team to conduct statistical analysis on healthcare data. Now, in partnership with the CSO and the Health Research Board (HRB), an application process has been put in place to enable registered researchers to apply to access the data for research purposes. A series of safeguards have been put in place to protect patient privacy under stringent and transparent rules while advancing our understanding of COVID-19 for the benefit of people’s health, patient care as well as health care policy and planning. Following a rigorous approval process, successful researchers will only have access to data from which

all identifiers such as names and addresses will be removed. The Minister said: “COVID-19 research plays an essential role in tackling the pandemic, identifying areas for targeted intervention and ongoing planning and evaluation of requirements; in addition to other public policy decisions. Modelled on best international practice, the mechanism we have in place with the CSO and the HRB will ensure that patient privacy and confidentiality is central when managing our approach to supporting valid research of this data. A key part of this will be the establishment a Research Data Governance Board to review applications to access the data for valid COVID-19 related research purposes.” An example of how research on this data could be used in practice would be to create a greater understanding of variation in COVID-19 risk in people with underlying conditions to tailor health promotion and protection measures. FDA ACCEPTS DUPIXENT® (DUPILUMAB) FOR REVIEW IN CHILDREN WITH MODERATETO-SEVERE ASTHMA The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged 12 and older with elevated eosinophils or oral corticosteroid dependent asthma. The target action date for the FDA decision is October 21, 2021 and the EU regulatory submission for children aged 6 to 11 years with asthma is planned for Q1 2021. In the U.S., approximately 75,000 children aged 6 to 11 years are living with uncontrolled moderateto-severe asthma, which can

carry a significant burden for children and their families. Despite treatment with current standardof-care inhaled corticosteroids and bronchodilators, these children can still experience coughing, wheezing, and difficulty breathing. They are also at risk for lifethreatening severe asthma attacks that can lead to hospitalization and emergency room visits, and may require the use of systemic corticosteroids which carry significant risks when used long term. Uncontrolled moderate-tosevere asthma can impair lung function, and can interfere with day-to-day activities, such as sleeping, attending school and playing sports. The sBLA is supported by data that include pivotal Phase 3 results evaluating the efficacy and safety of Dupixent in addition to standard-of-care maintenance therapy in children with moderateto-severe asthma with type 2 inflammation, characterized by elevated blood eosinophil levels and/or raised fractional exhaled nitric oxide (FeNO) levels. In the trial, Dupixent significantly reduced severe asthma attacks and rapidly improved lung function within two weeks in children aged 6 to 11 years. Safety results were generally consistent with the well-established safety profile of Dupixent in the approved indication for patients aged 12 and older with moderateto-severe asthma. Adverse events in the Phase 3 trial that were more commonly observed with Dupixent included injection site reactions, viral upper respiratory tract infections and eosinophilia. Detailed results from this Phase 3 trial will be published later this year. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis and eosinophilic esophagitis.

World Kidney Day Transplant father and son brave cold sea to mark World Kidney Day 11th March 2021. Inspired by his kidney transplant father, Cian Carty Heffernan (24) decided to support the Irish Kidney Association (IKA) and mark World Kidney Day, Thursday 11th March 2021, by completing a 4 X 4 X 48 Challenge in his native Skerries, Co Dublin which he began two days previously. Peter Heffernan joined his son for a 200-meter swim in the cold Irish sea after one of Cian's 4 mile runs which he undertook every four hours over the two days. To celebrate the theme of World Kidney Day 2021 'Living Well with Kidney Disease', the IKA also joined forces with the Irish Nephrology Society and Walking Ireland to encourage kidney patients and their family and friends to begin their own challenge this week, a 21 Day Walking Challenge, and to finish up during Organ Donor Awareness Week (27th March – 3rd April). For more details visit www.ika.ie/kidneyday21 Picture Conor McCabe Photography.

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Clinical R&D

MEDTECH MASK SPRAY BLOCKS 99% OF PATHOGENS A medical technology spin-out company at NUI Galway has developed a groundbreaking new barrier spray making re-usable masks up to 99% effective at blocking airborne pathogens and particles. ProShield has been developed by scientists and researchers at Aquila Bioscience to create a safe, nanofibre protective coating on material, an added defence against airborne pathogens. Inspired by the development of its first product, the ABD Device, a novel decontamination wipe, Aquila Bioscience successfully applied its signature Pathogen Capturing Technology (PCT) to ProShield, an environmentally conscious, alcohol free, safe spray. PCT is inspired by nature and is based on glycoscience, the study of protein and carbohydrates. It contains microscopic Velcro-like structures specifically designed to bind and neutralise harmful pathogens. David Murphy, Director of Technology Transfer and Innovation, NUI Galway, said: “Timing is everything. Aquila Bioscience had developed the technology and now, in less than 12 months, they have developed a range of exciting products to address the global need for protection against Covid-19 and other pathogens. This remarkable journey is testimony to the expertise and dedication of the company, and the entrepreneurial environment at NUI Galway.” Professor Lokesh Joshi, founder of Aquila Bioscience, said the innovation was also driven by the need to increase protection of reusable masks, to reduce dependence on disposable masks and ultimately to protect the environment by reducing plastic waste.

“With growing awareness of waste created by single use PPE and the toll it is taking on the environment, it is imperative that we develop innovative, environmentally conscious products that are safe to use and effectively protect users,” Professor Joshi said. “Due to an exponential rise in the number of disposable masks used daily, there has been a huge surge in ocean pollution worldwide. Discarded plastic masks end up everywhere - roadsides, fields, lakes, rivers and all the way to the oceans, getting tangled up in wildlife along the way. They can take hundreds of years to slowly degrade into microplastics which are then ingested by marine life. “People should be advised to wear reusable face masks and now we have a technology, inspired by nature, to improve protection from fabric/cotton masks by blocking up to 99% of airborne pathogens.” The ProShield scientifically developed technology was tested for its efficacy using a variety of fabric materials and its ability to capture and block airborne pathogens. The results showed that ProShield dramatically improves the efficacy of the fabric material to block pathogens by between 94% and 99.5%. ProShield is the second pilot product developed and released by Aquila Bioscience and is alcohol free, eco-friendly and safe for all to use. FINNISH RESEARCHERS INTRODUCE A NASAL COVID VACCINE Rokote Laboratories Finland Ltd., a newly-founded academic spinout based in Finland is working to develop and introduce to the markets a nasal spray vaccine against COVID. The vaccine is based on research carried out at

the University of Helsinki and the University of Eastern Finland. The vaccine uses gene transfer technology developed at the University of Eastern Finland by Academy Professor Seppo Ylä-Herttuala's research group, and the technology has already been successfully used in several clinical trials using gene therapy to treat cardiovascular diseases and cancer. The vaccine uses a safe adenovirus carrier that contains a cloned DNA strand, which causes nasopharyngeal cells to produce the virus protein which, in turn, produces a response to the vaccine. There is no actual SARS-CoV-2 virus in the vaccine. Preliminary results show that the vaccine has performed well in animal studies, and clinical testing in humans will start within a few months. Nasal delivery was chosen as the new vaccine's method of administration because the virus is also naturally transmitted through the airways. Indeed, nasal administration seems to induce a wider immune response than intramuscular administration. “Vaccines injected intramuscularly produce IgG antibodies in the bloodstream, but nasal vaccines also produce an IgA response that protects mucous membranes. We assume that this can also prevent those who have received the vaccine from transmitting the virus,” Academy Professor Seppo Ylä-Herttuala from the University of Eastern Finland says. According to him, the currently ongoing vaccination programmes do not eliminate the need for new vaccines, as new variants are expected to cause new waves of infection. “Even if we were able to vaccinate the entire population, at least people in medical risk groups will

still need new vaccines against new variants in the upcoming years. The vaccines currently in use provide a clearly lower protection against the South African variant, which will likely be the dominant virus in the next wave. Our vaccine already takes into account the most important variants, i.e. the South African, Brazilian and the UK one. There will certainly be a demand for this type of vaccine,” says Professor of Virology Kalle Saksela from the University of Helsinki. The company will carry out the first clinical vaccine trials in Finland. In Kuopio, there is already the commercial technology needed to produce the vaccine. The founders and board members of Rokote Laboratories Finland Ltd. are the vaccine developers Academy Professor Seppo YläHerttuala from the University of Eastern Finland, Professor Kalle Saksela and Professor Kari Alitalo from the University of Helsinki, and Mr Pasi Kemppainen, MSc (Techn.). The University of Helsinki and the University of Eastern Finland are also co-founders of, and shareholders in, the company. According to Mr Kemppainen, the company is now negotiating on funding to ensure further development of the vaccine and its moving towards clinical trials. After being granted a marketing authorisation, the vaccine could ensure Finnish and European security of supply, and vaccine self-sufficiency. “The vaccine can be manufactured in considerable quantities here in Kuopio and, in the long term, it can also be licensed outside Europe. The current focus is, of course, on the COVID vaccine, but the same method can also be used to develop vaccines against other viruses,” Mr Kemppainen says.

First Ever Irish Health & Market Access Landscape Report Launched The first ever health & market access landscape report for Ireland was launched by AXIS Consulting on Wednesday 24th March 2021. Entitled “The Irish Health & Market Access Landscape Report”, it provides a comprehensive overview of the Irish health ecosystem with a particular focus on how reimbursement decisions on new medicines are made. Written by the expert team of market access specialists and health economists at AXIS Consulting, this 43page report includes essential information on the Irish reimbursement system, outlines the regulations and laws governing Irish reimbursement and provides key insights on how the various bodies involved in decision making in Ireland connect and interlink. Launching the report Brenda Dooley, Chief Executive at AXIS Consulting said, “With an overall health budget of ¤21 billion in 2021 representing an additional ¤4 billion including ¤50 million for new drugs this year, its critical for companies wishing to operate in this market to have a strong understanding of the local economy in order to be able to understand how resources are allocated. The Irish Health & Market Access Landscape Report is a central repository of information on the Irish health landscape. It will be particularly useful for those outside the country who are seeking to operate more effectively in the Irish market, or learning to navigate the reimbursement landscape successfully in new markets such as Ireland.” The Irish Health & Market Access Landscape Report is available to purchase on the AXIS Consulting Website www.axisconsulting.ie - For further information please contact kavi@axisconsulting.ie

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107 Say Yes to Summer with Telfast Allergy For many of the 25%1 of people in Ireland that suffer with seasonal allergies – the thought of the sneezy season ahead may bring a tear to their eye! While many will be looking forward to the warmer weather in spring and summer, those with hayfever may be dreading the havoc that it can cause due to the uncomfortable symptoms, from runny noses, itchy and watery eyes, to that all too familiar sneezing2. The impact of seasonal allergies can be significant, especially for the 70% of moderate sufferers and over one in five (21%) who have to cope with more severe symptoms2. However, by adapting their lifestyle habits and getting expert advice to find the right treatment early, they can start saying yes to living their life, not their allergies with these tips this hayfever season. Telfast® Allergy 120mg Film-coated tablets3 contain fexofenadine hydrochloride, a new generation antihistamine that provides fast, long-lasting and non-drowsy relief4 for seasonal allergy symptoms. It works by preventing the effects of histamine, a substance produced by the body when exposed to certain allergens, such as pollen5. * Available now from pharmacy without prescription, Telfast® Allergy 120mg Film-coated tablets fexofenadine hydrochloride5 gets to work to relieve nose, throat and eye symptoms within one hour. Just one tablet a day offers long-lasting 24-hour relief, with a clinically proven non-drowsy formula, suitable for adults and children 12 years and older. Telfast® Allergy 120mg Film-coated tablets fexofenadine hydrochloride5 is available from leading and independent pharmacies, priced at RRSP ¤12.99 for 30 film-coated tablets. Always read the label. Ask your doctor or pharmacists for further advice. Legal Category: P. Marketing Authorisation Number: PA540/170/1. Marketing Authorisation Holder: Sanofi-aventis Ireland Ltd., T/A SANOFI Citywest Business Campus Dublin 24 Ireland. Further information is available from: Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com. Date of Preparation: September 2020 Adverse events should be reported. Reporting forms and information can be found at: www.hpra.ie E-mail: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland - Tel: 01 403 5600. Alternatively, send via E-mail to IEPharmacovigilance@sanofi.com References 1 BPT allergic rhinitis suffering & treatment Ireland MAT 2019 2 Irish Toluna allergy study Aug’20 – symptoms & severity; quotes from Sanofi category leadership guide 3 Telfast Allergy SPC - https://www.medicines.ie/medicines/telfast-allergy-120-mg-film-coated-tablets-34996/spc [Last accessed February 2021] 4 Church M.K. (2016) Allergy, Histamine and Antihistamines. In: Hattori Y., Seifert R. (eds) Histamine and Histamine Receptors in Health and Disease. Handbook of Experimental Pharmacology, vol 241. Springer, Cham. 5 https://www.hse.ie/eng/health/az/a/antihistamines/who-can-use-antihistamines.html [Last accessed February 2021]

BOEHRINGER INGELHEIM SEES POSITIVE BUSINESS MOMENTUM IN 2020 Boehringer Ingelheim stepped up its investments in R&D significantly in 2020 in pursuit of innovative medicines and therapies for diseases for which no satisfactory treatments are available. In particular, efforts to research potential Covid-19 related therapies were accelerated. The company spent 3.7 billion EUR on R&D, 7% more than in the previous year. This represents the highest annual investment in R&D in the 136-year history of the research-driven biopharmaceutical company. "We started our R&D for potential Covid-19 therapies early in the first quarter of 2020, recognizing the urgent need," said Hubertus von Baumbach, Chairman of the Board of Managing Directors. "Together with many partners worldwide, this work is ongoing. Our employees have done remarkable work to fight Covid-19, ensure our medicines continued to reach patients

and animals, and physicians continued to be supported. Our achievements in 2020 are the result of their effort." Building on its vast knowledge in various therapeutic areas, such as respiratory diseases and virology, Boehringer Ingelheim is engaged in several projects aimed at finding medical solutions to treat Covid-19. In December 2020, the company announced together with Cologne University Hospital, the University of Marburg, and the German Center for Infection Research the initiation of Phase I/IIa clinical investigation of BI 767551, the first SARS-CoV-2 neutralizing antibody administrated via inhalation as a potential new therapeutic and prophylactic option to block the virus at the site of infection. Other Covid-19 initiatives include the research and development of SARS-CoV-2 antibodies that can be combined with BI 767551, small molecules to inhibit its replication, and therapy development to prevent microcoagulation (blood clots).

2020 was a good year for Boehringer Ingelheim, although the effects of the Covid-19 pandemic were omnipresent. All of its businesses contributed positively to net sales and operating income. The company recorded net sales of 19.57 billion EUR, a 3% increase compared to the previous year. Foreign currency headwinds had a considerable impact; adjusted for currency effects, net sales rose by 5.6% year on year. The 2020 Annual Report can be found here: https://annualreport. boehringer-ingelheim.com/ OVER ¤1 MILLION FOR SINGLE CELL IMAGING RCSI University of Medicine and Health Sciences has received a nearly ¤1.2 million SFI infrastructure award to develop a high-resolution imaging system, with an automatic microdissection and single-cell sequencing facility. The research infrastructure will provide new information on the molecular makeup of individual

cells in complex tissues and structures, enable research towards personalised medicine and help in the development of novel diagnostics, therapeutics and biomaterials. In addition to the SFI infrastructure award, the project is being established and co-funded by RCSI University of Medicine and Health Sciences. Using the new system, cells and tissues labelled with fluorescent markers will be scanned, and objects of interest identified by real-time image processing to trigger super- resolution imaging or laser microdissection and capture. "This project will make more scientific discoveries possible for researchers in RCSI and in other institutions throughout Ireland. I would like to congratulate Professor Prehn and everyone involved for securing this important funding from Science Foundation Ireland," said Professor Fergal O'Brien, RCSI Director of Research and Innovation.

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120 mg Film-coated tablets Fexofenadine hydrochloride

T H E O N LY

✓ FA S T - AC T I N G ✓ LO N G - L A S T I N G * ✓ N O N - D ROWS Y H AY F E V E R R E L I E F

LIV E YOU R LI F E , N OT YOU R ALLE RG I E S *In clinical trials vs placebo Telfast Allergy 120mg film-coated tablets Product Information Presentations: Telfast Allergy (fexofenadine hydrochloride) 120mg film-coated tablets, containing equivalent to 112mg of fexofenadine. Indications: Telfast Allergy is indicated in adults and children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis. Dosage and Administration: Adults and Children ≥ 12 years: The recommended dose is one tablet (120mg) once daily taken before a meal. Children (<12 years old): The efficacy and safety has not been studied. Elderly; Renally or Hepatically impaired patients: studies indicate that dose adjustment is not necessary but Telfast Allergy should be administered with care in these patients. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions and Warnings: Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines, have been associated with the adverse reactions, tachycardia and palpitations. Interactions: Coadministration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to increase the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval or an increase in adverse reactions compared to the medicinal products given singly. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids. Pregnancy: Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary. Breast-feeding: Fexofenadine hydrochloride is not recommended for mothers breast-feeding their babies. Adverse Reactions: The following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo. Common (≥1/100 and<1/10): Headache, drowsiness, dizziness, nausea. Uncommon (≥1/1,000 and <1/100): Fatigue. The following undesirable effects have been reported in post-marketing surveillance. Frequency not known: Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis, insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria) tachycardia, palpitations, diarrhoea, rash, urticaria, pruritus. Legal Category: P. Marketing Authorisation Number: PA540/170/1. Marketing Authorisation Holder: Sanofiaventis Ireland Ltd., T/A SANOFI Citywest Business Campus Dublin 24 Ireland. Further information is available from: Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com. Date of Preparation: September 2020 Adverse events should be reported. Reporting forms and information can be found at: www.hpra.ie E-mail: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland - Tel: 01 403 5600. Alternatively, send via E-mail to IEPharmacovigilance@sanofi.com MAT-IE-2100473 (v1.0) March 2021