IPN 2023 April

Biodegradable

In this issue:

NEWS: Calls for pharmacy role expansion Page 4

MEDICINES: Pharmacist-led medication reviews Page 6

FEATURE: Making decisions about Fertility treatment Page 16

CONFERENCE: IPHA host Annual Conference in Dublin Page 20

CPD: Emergency Contraception Page 39

FINANCE: State Pension Opportunities Page 46

AWARDS: OTC & Retail Pharmacy Product Award Winners Page 50

TEAM TRAINING: Sleep Disorders Page 78

Part of the OPTASE family.

Foreword

Page 5: Adrian Dunne Pharmacy a ‘Great Place to Work’

Page 6: Pharmacist-led medicines reviews in GP practice

Page 12: New targets for managing diabetes

Page 14: Medicine shortages for asthma patients

Page 16: Pharmacy role in infertility treatment and advice

Page 20: European proposals will degrade development of new medicines

Page 24: No proposals for Chief Pharmaceutical Officer

Page 50: OTC Retail Pharmacy Product Award winners 2023

PUBLISHER:

IPN Communications

Ireland Ltd. Clifton House, Fitzwilliam Street Lower, Dublin 2 00353 (01) 6690562

MANAGING DIRECTOR

Natalie Maginnis n-maginnis@btconnect.com

EDITOR

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

ADVERTISING EXECUTIVE

Amy Evans: amy@ipn.ie

EDITORIAL/ EVENTS & MARKETING EXECUTIVE

Aoife Hunter: aoife@ipn.ie

CONTRIBUTORS

Caitriona Fitzpatrick

Sarah Magner

Gaston L. Cluzel

Noel M. Caplice

Helen Forristal

Duarte Nunes da Silva

Kieran Moore

DESIGN DIRECTOR

Ian Stoddart Design

Irish Pharmacy News is circulated to all 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.

The Joint Oireachtas Committee on Health was recently told that there is significant untapped potential in Ireland’s community pharmacy sector. Addressing the Committee the Irish Pharmacy Union (IPU) outlined a series of proposals to expand the range of services available at pharmacies, which will improve patient care and relieve pressure on the health system. President of the Irish Pharmacy Union and Cloyne based pharmacist Dermot Twomey will say, “Community pharmacy is recognised as the most accessible element of our health service. There is a pharmacy in nearly every town and village in the Country, with 85% of our population living within 5 km of one. Community pharmacy provides a ready-to-go health infrastructure which we believe can be utilised better.”

Turn to page 4 to read the full story.

On page 6, Leon O’Hagan, Senior Pharmacist iSIMPATHY Project (Louth) gives readers an overview of pharmacist-led medicines reviews within GP practices.

Over the past two years, GPs in border counties and their patients have benefitted from a novel EU-funded project. iSIMPATHY delivers an interdisciplinary collaborative approach centred around pharmacist-led medicines reviews. Clinical pharmacists have joined 11 practices and have delivered holistic person-centred medicines reviews with over 2,200 patients with complex medication needs.

In other news, medicine shortages continue to impact patient care. The most recent report show the number of medicine shortages in Ireland up an additional 19 medicines in short supply since the end of last month, and a 38% increase since the Index began in October. Of the 247 medicines currently unavailable, 13 are listed on the World Medical Organisation’s (WHO) ‘critical medicines’ list. Read the full article on page 14. This issue also showcases all the winners from the 2023 OTC & Retail Pharmacy Product Awards. These are the only industry Awards that specifically recognise and reward the companies and their products within the OTC market, acting as a celebration and showcase of product innovation, marketing and value to its customer.

Originally launched in 2008, the Awards were judged by an independent panel, comprising of over 40 judges from across the community pharmacy sector, representing both multiple and independent pharmacies, buying groups, wholesalers and industry. Once again the judges were overwhelmed by the quality and quantity of products. Turn to page 50 for all the winners and details on product selection from members of the judging panel.

I hope you enjoy the issue.

Regulars

FEATURE: WOMEN’S INTIMATE HEALTH

FEATURE: GUT HEALTH

FEATURE: BOWEL CANCER

CPD: EMERGENCY CONTRACEPTION

FINANCE: UK STATE PENSIONS

P26

P32

P36

P39

P44

CLINICAL PR: P80

Calls for Expansion in the role of Pharmacists

The Joint Oireachtas Committee on Health was recently told that there is significant untapped potential in Ireland’s community pharmacy sector. Addressing the Committee the Irish Pharmacy Union (IPU) outlined a series of proposals to expand the range of services available at pharmacies, which will improve patient care and relieve pressure on the health system.

internationally, would prefer to obtain contraception from the pharmacist. Making contraception available direct from pharmacies would provide the patient with greater choice and also serve to reduce pressure on GPs.

Irish Cancer Society Awards

People involved in groundbreaking research projects around the country were honoured at the Irish Cancer Society Research Awards recently.

President of the Irish Pharmacy Union and Cloyne based pharmacist Dermot Twomey will say, “Community pharmacy is recognised as the most accessible element of our health service. There is a pharmacy in nearly every town and village in the Country, with 85% of our population living within 5 km of one. Community pharmacy provides a ready-to-go health infrastructure which we believe can be utilised better.”

Pharmacies are committed to the Sláintecare ethos, according to Mr Twomey. “This centres around ensuring that the right care, is delivered in the right place, at the right time for all patients. We believe there is tremendous potential to realise this ambition by better utilising the skill set of pharmacists,

by facilitating them to work to their full scope of practice.”

Amongst the recommendations the IPU outlined to the Committee was the introduction of a Minor Ailment or Triage service. Under this scheme, public patients with minor self-limiting conditions would no longer require GP appointments. Instead, they could consult with their local community pharmacy team, receive an assessment of their symptoms followed by a combination of advice, medication supply and/ or referral to other services. This scheme can be extended by increasing the number of treatments available directly from the pharmacist so as to widen healthcare access for both public and private patients.

“This is a clear example of an opportunity to radically reimagine the delivery of timely care within the community and deliver cost-effective, safe and desired health outcomes. It has the potential to free up GP capacity by eliminating the need for over 1 million appointments a year, said Mr Twomey.

Access to contraception

While the IPU welcome the introduction of free contraception and its further planned expansion the organisation believes that reducing barriers to accessing contraception is required.

“Research has shown that many women, both in Ireland and

The IPU called for the more effective utilisation of pharmacists to manage medicine shortages. “Facilitating substitution, where there is a shortage of medicines, without the need to revert to the prescriber will speed up supply and reduce the stress on patients, pharmacists and doctors.”

“To fully deliver on their potential the sector must be adequately resourced with pharmacies receiving fair reimbursement for the services it provides on behalf of the state. Pharmacy’ fees have not changed since 2008 and have not kept in line with crippling inflation. Our average dispensing fee is now lower than it was in 2008, nearly 15 years ago. We require action to support the sector in order for it to continue expanding its range services”, Mr Twomey will inform the Committee members.

Concluding, Dermot Twomey, President of the Irish Pharmacy Union said, “As a country we need to take a more proactive approach to the management of pharmaceutical care in general. One of the most fundamental and seismic changes which should be prioritised to unlock the potential of community pharmacy, is to develop an agreed national strategy for pharmaceutical care to deliver better health outcomes for patients. This should be owned by the Minister for Health and driven by the appointment of a Chief Pharmaceutical Officer within the Department of Health.”

Among those to claim top honours were Senior Researcher of the Year Award Recipient, Dr Janice Richmond, as well as Ashley Bazin from the Clinical Trials Unit at Tallaght University Hospital who scooped the Support Staff of the Year title. The prize of PhD Researcher of the Year went to Rebecca O’Brien, with Kay McKeon taking home the award for Patient and Public Involvement (PPI) Champion of the Year.

The event celebrated the central contribution of patients and survivors to innovative research projects that help to improve the lives of those impacted by cancer. This was reflected in the category of Patient and Public Involvement (PPI) Champion of the Year, which went to breast cancer survivor Kay McKeon for her valuable input across a number of cutting-edge programmes.

Commenting on her award which recognises her contribution of a patient perspective to a number of developments, including an eHealth portal to address information deficits for those affected by cancer, graphic designer Kay McKeon said:

“The information deficits that I and other patients have experienced inspired that research. It changed my life, and I love that I can use my design work to help others.”

Welcoming her Support Staff of the Year award recognising her long service to the Oncology and Haematology Clinical Trials Unit in Tallaght University Hospital, Ashley Bazin said, “It’s so rewarding working with patients in this role. You’re constantly offering hope with the new treatments available, which is very satisfying. When I saw what was written about me for the nomination it brought home all that’s involved in the role which you never really think about day to day.”

Irish Pharmacy Union President, Dermot Twomey

Rare Disease Plan

The Minister for Health Stephen Donnelly has marked Rare Disease Day by announcing that his department is to develop a new National Rare Disease Plan.

Pledging support to people living with rare diseases the Minister confirmed that work is due to commence on the new National Rare Disease Plan, in line with the commitment in the Programme for Government.

Improving and expanding the care and treatment of patients with rare diseases is a priority for the government, with work spearheaded by the HSE National Clinical Programme for Rare Diseases.

The government has also substantially increased funding for new innovative medicines for rare diseases, investing ¤100 million over the last three Budgets.

During this time, more than 100 new medicines have been approved, including 34 orphan medicines to treat rare diseases.

In 2023, the government has committed ¤2.7 million to support the implementation of this Strategy.

Minister Donnelly said, “I understand that patients living with rare diseases and their families face huge challenges in managing and treating their conditions, and these challenges are heightened by the lack of information and research into these diseases.

“As a health service, we are working to change this. Personalised treatments will help transform healthcare provision in Ireland, and this vision has already been laid out with the recent launch of the National Strategy for Accelerating Genetic and Genomic Medicine in Ireland.”

Last year the HSE was nominated as the National Competent Authority in an EU Joint Action of European Reference Networks for Rare Diseases, which enables greater coordination and sharing of best practices in key areas such as genetic testing.

Highlighting the importance of this EU-wide approach, the Chief Medical Officer Professor Breda Smyth said:

“This collaboration has allowed us to enter into 18 European Reference Networks (ERNs) on Rare Diseases.”

Pharmacists calls for greater choice for women

The Irish Pharmacy Union (IPU) has called for government to expand the accessibility of the free contraception scheme for young women. The IPU has said that women should be given the choice to access contraception directly from their pharmacist, on foot of a structured consultation. This will provide women with even more options to safely and effectively manage their reproductive health and wellbeing.

Speaking on International Women’s Day pharmacist and Chair of IPU’s PCC Committee Kathy Maher explained the benefits of expanding choices to women. “Pharmacies are easily accessible and located in practically every town and village in the country. Women can visit their pharmacy at times that suit them in evenings or weekends. Women should have the choice to avail of this convenience to access contraception.”

Many women already opt to access emergency hormonal contraception through pharmacies, explained Ms Maher. “Pharmacists are experienced at providing contraceptive care and have been safely providing the emergency contraception, over the counter

since 2011. The profession is trained and has the experience to review patients to determine if it is safe to dispense contraception without referring to a GP.

“Pharmacists experience has taught us that many women prefer to access contraception from their pharmacies. Where this is their preference, they should have that choice. This is a view that is now shared by the World Health Organisation who recommended in 2019 that oral contraception should be available without prescription.”

“The introduction of the scheme to offer free contraception was extremely welcome. It is now set to be expanded this year in another positive development for women. However, without enlisting

pharmacies this expansion will add further pressure to GPs, while also making it more challenging for women to access the scheme. Better healthcare means using all of our primary care resources effectively. Allowing young, healthy women to access contraception from a range of healthcare providers improves choice and by extension access thus making an important service available to even more women.

Concluding, Ms Maher said, “we are calling on the Minister for Health to revise the new free contraception scheme, providing women the choice to access the pill in their pharmacies. This should be implemented before the planned expansion of the scheme in the coming months.”

Adrian Dunne Pharmacy - One of the Best Workplaces™ in Ireland

The Adrian Dunne Pharmacy Group were celebrating recently having been named as one of Ireland’s Best Workplaces™ 2023. The announcement was made at the annual Great Place to Work™ Awards in Dublin.

Certification as a Great Place to Work™ is based on direct feedback from employees as part of an independent, extensive and anonymous survey about the workplace experience.

Since opening its first branch in Whitehall in 1999, the Adrian Dunne Pharmacy team have dedicated themselves to developing a great place to work. The tremendous team spirit, enthusiasm, and positive attitude has created an award-winning culture and Best Workplace for all the team, whilst also providing a great experience for the customer. Managing Director Adrian Dunne said, “Our people are at the very foundation of what we do – their dedication, enthusiasm and compassion underpin our exceptional customer care. We are committed to engaging and listening to our people, promoting and living our values, and investing in our team. We’re very proud of our people and thrilled to have been recognised as one of Ireland’s Best Workplaces.”

Adrian Dunne, Managing Director with team from Adrian Dunne Pharmacy Group

Pharmacist-led medicines reviews in GP practice; The iSIMPATHY project

Written by Leon O’Hagan MPSI - Senior Pharmacist iSIMPATHY Project (Louth)

across the world. The WHO third Global Patient Safety Challenge, Medication Without Harm, aims to reduce severe avoidable medication-related harm by 50%, globally in the next 5 years.2 The WHO highlight three priority areas for action to reduce medicationrelated harm; polypharmacy, transitions of care and high-risk medicines. The iSIMPATHY medicines reviews address the risks associated with these three priority areas.

Impacts of Inappropriate Polypharmacy:

Inappropriate polypharmacy can have a substantial detrimental impact on patients, with avoidable harm and decreased quality of life.

Non-Adherence

• Estimates suggest that half of all medicines are not taken appropriately costing the EU 125 billion annually.7

Introduction/Summary

Over the past two years, GPs in border counties and their patients have benefitted from a novel EUfunded project. iSIMPATHY delivers an interdisciplinary collaborative approach centred around pharmacist-led medicines reviews. Clinical pharmacists have joined 11 practices and have delivered holistic person-centred medicines reviews with over 2,200 patients with complex medication needs, with changes made in collaboration with the GP. The approach is highly effective at identifying and addressing the risks associated with complex polypharmacy, incorporating shared decision making and improving patient understanding and experience. The project has been welcomed by GPs. This article describes the initiative and outcomes of iSIMPATHY to date, including GP and patient experience.

What is iSIMPATHY?

iSIMPATHY (implementing Stimulating Innovation in the Management of Polypharmacy and Adherence Through the Years) is a European project funded in the EU Interreg VA programme, and managed by the Special EU Programme Body, that involves a partnership between the HSE, the Scottish Government, and the Medicines Optimisation and Innovation Centre (MOIC) in Northern Ireland.

The project has recruited and trained 5 senior clinical pharmacists, who work in 11 GP practices in counties Donegal, Sligo, Leitrim, Cavan, Monaghan and Louth.

iSIMPATHY pharmacists are delivering holistic person-centred medicines reviews, focussing on patient needs and wants, as well as addressing clinical and safety considerations. iSIMPATHY adopts the Scottish 7-Step methodology (figure 1), which facilitates shared decision making and improved understanding, in addition to optimising medicines to improve outcomes.1 The pharmacists liaise with the GPs and other healthcare professional who action the changes as appropriate.

Why review medicines?

Medication and its omission is a leading cause of avoidable harm

Over 250,000 adults in Ireland receive 10 or more prescribed medicines on a regular basis.3 The concept of ‘appropriate polypharmacy’ recognises that patients can benefit from multiple medications provided that prescribing is evidence based, safe and reflects patients’ clinical conditions and priorities.1

As polypharmacy increases, there is a greater risk of inappropriate polypharmacy.1 This occurs when the potential harm for one or more medication(s) outweigh potential benefits because:

• There is no evidence-based indication

• The therapeutic objectives are not being/likely to be achieved

• There is an unacceptable risk of ADRs

• Non-adherence is associated with increased healthcare utilisation.8

• Non-adherence to diabetes therapy is associated with an 80% increased risk of death.7

• The more empowered patients feel, the more motivated they will be to adhere to their medications and to manage their conditions.9

Medication-Related Harm

• Inappropriate polypharmacy is associated with a higher rate of GP and Emergency Department visits.3,10

• ADRs are responsible for 1 in 10 hospitalisations in OECD countries.7

• Medications with a greater risk of ADRs include antithrombotics, antihypertensives,analgesics, anti-diabetics and antipsychotics.11,12

Members of the iSimpathy Team in Ireland Project Pharmacists Clare Kinahan, Emma-Jane Coyle, Jacqueline Treacy, Leon OHagan and Niamh Feeley with Ciara Kirke, Work package & Clinical Lead, Joanne O’Brien, HR Lead CHO8, Trevor Hunter, HR lead CHO1 and Celine Croarkin, Project Management Lead

Figure 1. 7 Steps to Appropriate Polypharmacy

Salicylic acid, lactic acid.

- for warts and verrucas

Kind therapy...not cry therapy

Supplied in a complete treatment kit, with a simple once daily application, Salatac Gel offers a very convenient and painless way of treating warts and verrucas. Salatac Gel dries to a water-resistant film... no need for plasters.

Recommend

Prescribing information

Salicylic acid 12.0% w/w, lactic acid 4.0% w/w.

Uses: For the topical treatment of warts, verrucas, corns and calluses.

Directions: Adults, children and the elderly: Apply once daily until the wart, verruca, corn or callus has disappeared (treatment may take up to 12 weeks). Soak the affected area in warm water for 2-3 minutes and dry with patient’s own towel. Carefully apply one or two drops to the lesion avoiding the surrounding skin. (Peel off the previous day’s gel before reapplying). Once a week gently rub away the treated surface with an emery board to remove any hard skin before re-application of the gel.

Contra-indications, warnings, side effects etc: Please refer to SPC for full details before prescribing. Do not use if sensitive to any of the ingredients. Not to be used on or near the face, intertriginous or anogenital regions, or by diabetics or individuals with impaired peripheral blood circulation. Not to be used on moles or on any other skin lesions for which it is not indicated. Keep away from the eyes, mucous membranes and from cuts and grazes. Some mild, transient irritation may be expected, but in cases of more severe or persistent pain/irritation, the treatment should be suspended or discontinued. Avoid inhaling vapour. Highly fl ammable, keep away from fl ames.

Package quantity, trade price and MA number:

8g tube with applicator. € 5.86, PA23128/007/001

Legal category: Supply through pharmacy only.

Further information is available from: Dermal Laboratories (Ireland) Ltd, Head Offi ce Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK.

Date of preparation: February 2021

‘Salatac’ is a trademark.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Dermal.

iSIMPATHY patient cohort: iSIMPATHY aims to target those patients at greatest risk of inappropriate polypharmacy:

• Prescribed 10+ regular medicines,

• On medication or combinations considered particularly highrisk for adverse events such as bleeding or acute kidney injury,

• Adults of any age, approaching the end of their life due to any cause, or

• Aged 50 years and older and resident in a residential care setting e.g. nursing home, intellectual disability residential setting or community hospital.

Incorporation of iSIMPATHY medicines reviews into GP Practice

Patients likely to benefit from a review are identified from referrals from GPs, community and hospital pharmacists, practice and hospital nurses and through the pharmacist identifying suitable patients from audit of the GP practice records. The pharmacist contacts the patient and provides information about the review process. If the patient agrees, a suitable appointment is arranged (face to face or telephone consultation). The patient (and/or carer) then meet with the pharmacist to carry out a comprehensive, person-centred medicines review. Reviews begin with what matters to the patient, identifying which medicines are essential, unnecessary, effective or ineffective, harmful or have

the potential to harm and if more cost effective alternatives would be appropriate. The pharmacist and patient agree an approach to adjusting medicines.

The pharmacist then provides the patient’s GP with a summary of the review and recommendations. The GP considers these recommendations and actions them as appropriate. The pharmacist follows up with the patient to discuss their experience with the changes.

Within GP practice, areas that have benefited from the presence of iSIMPATHY pharmacists include:

• Adding capacity - iSIMPATHY pharmacists have time to spend with patients to go over their medication in depth and to the patient’s satisfaction.

• CDM clinics: Medicines reviews delivered prior to the GP’s review of the patient under the Chronic Disease Management scheme has been found to be particularly effective and efficient. Pharmacists readily recruit new patients to CDM also.

• Effective contact with secondary care providers.

• Review of patients recently discharged from hospital.

• Antimicrobial Stewardship (e.g. 85% of long term antimicrobials were stopped following iSIMPATHY medicines review).

• Review of nursing home residents.

• Implementation of national guidance - Medicines Management Programme, PCERS and medication safety updates.

• Medicines Information.

• Contact with community pharmacies.

• Update of practice protocols.

• Provision of education and access to training resources e.g. Polypharmacy and Medication review online course currently available on the IIOP website (Polypharmacy eLearning will be available via HSeLand shortly).

Outcomes of iSIMPATHY to date:

• Over 2,500 reviews completed (March 2023).

• 98.2 % of iSIMPATHY pharmacist recommendations were accepted by the GP.

GP experience:

• Project GPs and pharmacists report iSIMPATHY is having positive effects on patient safety, quality of life, satisfaction, understanding, adherence and quality of care, and a positive effect on GP job satisfaction, knowledge and understanding.13

• GPs believe pharmacist knowledge and skills, capacity (time) to carry out reviews and pharmacist communication with the patient are key facilitators to the success of the project.

• GPs’ capacity (time available) to engage with the project is a challenge raised by both GPs and pharmacists. Pharmacists have worked with GPs and practice staff to streamline the service to avoid excessive GP workload, e.g. condensing review outcomes to a ‘5-minute read’ report, time allocated in GP schedule to review and enact the report.

• There is unanimous support for project to continue. GPs and pharmacists are also eager to see the role of the iSIMPATHY pharmacist expanded within the practice.

GP feedback:

Dr Majella Grealish, Bayview Family Practice, Ballyshannon:

“… the iSimpathy project contributes in a tremendous way to our practice. We no longer look at patients on large numbers of drugs and wonder where to start with rationalising them. As you are well aware, these are generally old and / or vulnerable people in society. In the past we may have tried to rationalise their medications, but this is too time consuming an endeavour for GPs. That is apart from the fact that pharmacy is not our speciality.

Dr Grace Kenny, The Square Medical Centre, Dundalk:

“From my point of view, Leon’s work and input are invaluable. His approach is patient-centred, encouraging, and empathetic. I have had only positive feedback from the patients, who are willing to either take, cut down, change, or cut out certain medication.

• His suggestions of change are always backed by guidelines, which he presents in typed format, making the changes easy to understand and comply with.

• I know I now find myself much more aware of polypharmacy and non-compliance, and I am putting some of what Leon has suggested into practice so it’s a win-win situation for both doctors and patients”

Complexity, deprescribing and Safety outcomes:

• Complexity:

o Mean patient age 77

o Mean of 7 comorbidities.

• Number of pharmacist interventions: A mean of 13 issues are addressed per patient (drug changes, education, monitoring, referrals, medication reconciliation and updating practice records). 80% are classified as significant or very significant and improving patient care; 33% of patients reviewed had an issue addressed which was classified as very significant, preventing a major organ failure or adverse reaction of similar importance.

• Deprescribing: A mean of 14 medicines pre- and

Figure 2. HSE GP Survey, July 2021

12 medicines post-review. The deprescribing process may be more complex and challenging than the initiation of drug treatment. iSIMPATHY pharmacists ensure that deprescribing is conducted is a safe, appropriate and evidence based manner.

• Safety: At least one Polypharmacy Indicator was identified for approximately 75% of reviews. These indicators flag that a serious adverse outcome is possible. 69% were resolved through iSIMPATHY medicines review.

Economic outcomes:

Although the primary purpose of polypharmacy reviews is in deriving clinical and quality of life benefits, they also deliver long-term direct and indirect economic benefits.

• Cost savings per review = ¤412

• Direct drug cost savings to HSE Mean ¤375 (95% CI ¤217 to 542)

• Hospital admission due to ADR avoidance: ¤36 per review

• Cost per review = ¤204

• 10 medicines reviews per working week per pharmacist (450 pa)

• Payscale + PRSI + equipment + travel & subsistence

• GP payment per review

• Net cost savings per review = ¤208

Patient experience:

• Patient, carer and family acceptability is high, with very high uptake of reviews and agreement with changes and very positive feedback received.

Patient feedback

“I’m not bleeding as often since my medication review”

“I’m definitely less short of breath and dizzy now”

“Once u got over the hump of withdrawing from Diazepam, I felt much better and my walking has improved greatly”

MSc in Clinical Pharmacy at UCC

“Pains in my legs used to limit my walking distance, but this improved after my medication review”

“Dad’s mood and appetite are much better since his medication review”

“There was a definite improvement in my constipation and shortness of breath. I had no idea that changing my tablets could help with these things”

The iSIMPATHY project is funded to March 2023. The project team are working to ensure high quality evaluation and publications to share the learning from this successful project in the Republic of Ireland. The benefits and strengths of this service have been acknowledged within the HSE and options for mainstreaming are being explored.

Further information on iSIMPATHY is available via www.isimpathy.eu or by contacting iSIMPATHY Project Manager Celine Croarkin via Celine.Croarkin@hse.ie

References available on request

GP Practices Participating in iSIMPATHY:

Bayview Family Practice, Bundoran and Ballyshannon, Donegal

Medicentre Barrack St, Sligo

Strandhill Surgery, Shore Road, Sligo

Dromahair Health Centre, Leitrim

Ballyjamesduff Family Practice, Cavan

Kingscourt Surgery, Cavan

Elm Surgery, Drumalee, Cavan

The Group Practice, Carrickmacross, Monaghan

The Square Medical Centre, Dundalk, Louth

Northgate Surgery, Drogheda, Louth

iSIMPATHY Project team

Project Lead: Ciara Kirke, Clinical Lead, National Medication Safety Programme, HSE Quality & Patient Safety Directorate

Senior Clinical Pharmacists: Clare Kinahan, Emma Jane Coyle, Jacqueline Treacy, Leon O’Hagan, Niamh Feeley

Project Manager: Celine Croarkin

HSE Primary Care Pharmacists: Joanne O’Brien and Trevor Hunter

Therapeutics Lead, ICGP: Dr Paul Ryan

HSE Steering Group: Joseph Ruane and Dermot Monaghan

Applications are invited for this two-year (part-time) distance learning Master’s Degree offered by the School of Pharmacy, University College Cork course, commencing in September 2023.

The course is structured to provide specialist training to enable pharmacists working in hospital and community pharmacies to extend their professional role within the evolving clinical healthcare system.

The course will promote a greater understanding of the major pharmacotherapeutic issues of various disease states in order to develop a greater understanding of the particular needs of patients with these diseases.

Graduates will gain the skills needed to become leaders in clinical pharmacy services, such as critical appraisal of drug therapies, rational drug use (including pharmacoeconomic evaluation), medication safety management, research project management, presentation skills and report writing.

The flexible, online learning format allows students to remain employed throughout the course. Students will be able to interact with each other and the experienced medical and pharmacy practitioners via webinars, video conferencing, and online discussion boards.

Applicants must hold a primary pharmacy degree and, ideally, have a minimum of one-year practical experience. Applicants must be registered as a pharmacist with the professional accreditation authority in the country where they practice.

Visit MSc Clinical Pharmacy online at www.ucc.ie/en/ckx03 to learn more about the course.

Closing date for applications: 30th June 2023

Applicants must apply online at www.ucc.ie/apply. Full details of the application procedure are available on this website. For further information please contact Dr Suzanne McCarthy (Interim Programme Director, S.McCarthy@ucc.ie) School of Pharmacy, University College Cork, Cork, Ireland.

Figure 3. Prevalence of Polypharmacy indicators identified and addressed through iSIMPATHY medicines review

DON’T WAIT UNTIL OSTEOPOROSIS STRIKES AGAIN

Rebuild bone before it breaks again—with Movymia®1

THE MEDICINES MANAGEMENT PROGRAMME RECOMMENDS

MOVYMIA® AS A BEST VALUE MEDICINE FOR TERIPARATIDE

RELIABLE: Movymia®’s quality, safety and efficacy is highly similar to its reference product1,3,*

EFFECTIVE: Anabolic MoA effectively rebuilds bone through the stimulation of osteoblasts1,4

AFFORDABLE: Allows more eligible patients to benefit due to its cost advantage5,6

RE-USABLE: One high quality reuseable pen for the entire treatment period1

MOVYMIA 20 MICROGRAMS/80 MICROLITERS SOLUTION FOR INJECTION

Each dose of 80 microliters contains 20 micrograms of teriparatide. One cartridge of 2.4 ml of solution contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml). Presentation: Glass cartridge. Indications: Movymia is indicated in adults. Treatment of osteoporosis in postmenopausal women and men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. Dosage: The recommended dose is 20 micrograms administered once daily. Patients should receive calcium and vitamin D supplements if dietary intake is inadequate. The maximum total duration of treatment is 24 months. The 24 month course should not be repeated over a patient’s lifetime. Following cessation of teriparatide therapy, patients may be continued on other osteoporosis therapies. Teriparatide must not be used in severe renal impairment. Use with caution in moderate renal impairment and impaired hepatic function. Teriparatide should not be used in paediatric patients (less than 18 years), or young adults with open epiphyses. Method of administration: Movymia should be administered once daily by subcutaneous injection in the thigh or abdomen. It should be administered exclusively with the Movymia Pen reusable, multidose medicine delivery system and the injection needles which are listed as compatible in the instructions provided with the pen. The pen and injection needles are not included with Movymia. However, for treatment initiation a cartridge and pen pack should be used. Movymia must not be used with any other pen. Patients must be trained to use the proper injection techniques. Contraindications: Hypersensitivity to the active substance or excipients. Pregnancy and Breast-feeding Pre-existing hypercalcaemia, severe renal impairment, metabolic bone diseases other than primary osteoporosis or glucocorticoid-induced osteoporosis, unexplained elevations of alkaline phosphatase, prior external beam or implant radiation therapy to the skeleton, patients with skeletal malignancies or bone metastases. Warnings and precautions: In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Therefore, if blood samples for serum calcium measurements are taken, this should be done at least 16 hours after the most recent teriparatide injection. Routine calcium monitoring during therapy is not required. Teriparatide may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials. Teriparatide should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition. In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, was relieved by placing subjects in a reclining position, and did not preclude continued treatment. Caution should be exercised in patients with moderate renal impairment. Experience in the younger adult population, including premenopausal women, is limited. Treatment should only be initiated if the benefit clearly outweighs risks in this population. Women of childbearing potential should use effective methods of contraception during use of teriparatide. If pregnancy occurs, teriparatide should be discontinued. The recommended treatment time of 24 months should not be exceeded. Contains sodium. Interactions: Digoxin, digitalis. Fertility, pregnancy and lactation: Women of childbearing potential should use effective methods of contraception during use of teriparatide. If pregnancy occurs, Movymia should be discontinued. Movymia is contraindicated for use during pregnancy and breast-feeding. The effect of teriparatide on human foetal development has not been studied. The potential risk for humans is unknown. Driving and operation of machinery: Teriparatide has no or negligible influence on the ability to drive and use machines. Transient, orthostatic hypotension or dizziness was observed in some patients. These patients should refrain from driving or the use of machines until symptoms have subsided. Undesirable effects: Nausea, pain in limb, headache, dizziness. Refer to Summary of Product Characteristics for other adverse effects. Pack size: 1. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance. Website: www.hpra.ie Marketing authorisation holder: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, German. Marketing authorisation number: EU/1/16/1161/001-003. Medicinal product subject toedical prescription. Date last revised: January 2022.

1. Movymia® SmPC. 2. Best Value Medicines https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-value-medicines/teriparatide/ Accessed February 2023.

3. Movymia® EPAR – public assessment report, available at: https://www.ema.europa.eu/documents/assessment-report/movymia-epar-public-assessment-report_en.pdf

4. Brixen KT et al. Basic Clin Pharmacol Toxicol. 200494(6):260–70. 5. Lyman GH et al. N Engl J Med. 2018378(21):2036–2044. 6. Janjigian YY et al. Future Oncol. 201814(23):2403–2414.* Forsteo®

Date prepared: March 2023. 2023/ADV/MOV/061H

New Targets for Managing Diabetes

A new report for the World Health Organisation has identified five core national targets for UN member states aimed at reducing diabetes risk and ensuring that people with diabetes have equitable access to comprehensive and affordable care and prevention.

Edward Gregg, Head of RCSI’s School of Population Health

with undiagnosed diabetes and many go without timely care for extended periods.

In high-income countries, the current proportions of people who meet recommended targets for risk factors, such as glycated haemoglobin or blood pressure, ranges from 50% to 70%.

The lead author on the report for WHO Global Diabetes Compact was Professor Edward Gregg, Head of RCSI’s School of Population Health. Its recommended targets, published in The Lancet, are:

1. Of all people with diabetes, at least 80% have been clinically diagnosed;

2. For people with diagnosed diabetes, 80% have glycated haemoglobin (HbA1c) concentrations below 8·0% (63·9 mmol/mol), an important biomarker for diabetes;

3. 80% of those with diabetes have blood pressure lower than 140/90 mm Hg;

4. At least 60% of those with diabetes who are 40 years or older are receiving therapy with statins;

5. Each person with type 1 diabetes has continuous access to insulin, blood glucose meters, and test strips.

Recent global estimates indicate that 537 million adults have diabetes, of whom 80% live in low-income and middle-income countries (LMICs). The global impact and cost of diabetes are expected to grow considerably, disproportionately affecting the most disadvantaged populations.

Population-based studies show that, at present, the delivery of evidence-based care for people with diabetes is suboptimal even in well-resourced health systems. Many countries have high proportions of their populations

The situation is worse in LMICs with just half of the people with a diagnosis of diabetes having good glycaemic control, and about one in four having good blood pressure control.

Professor Edward Gregg, Head of the School of Population Health, RCSI and lead-author on the report said: “Diabetes is one of the world’s most challenging public health issues due to its high and growing prevalence, and the impact it has on individuals, health systems and national economies. Yet we know that the worst outcomes from diabetes can be prevented and that many interventions are cost-effective and feasible to implement. However, there are enormous global gaps in their delivery that the efforts of the Compact can alter.

“Type 2 diabetes can be delayed or prevented through intensive lifestyle interventions and medication for individuals at high risk, and population-wide

changes to dietary quality, physical activity levels and prevalence of obesity. For people with diagnosed diabetes, delivery of essential medications and management of glycaemia and cardiometabolic risk factors, alongside early screening for complications via well organised care can reduce acute and chronic complications and extend life.”

According to Professor Gregg, “While these goals are ambitious, their achievement can reduce the number of people living with diabetes and greatly improve the outcomes and quality of life of people who are diagnosed with the condition. We hope the WHO Global Diabetes Compact serves as a helpful framework for countries to take action and reduce the burden of diabetes globally.”

The Global Disease Compact was assembled by the WHO to identify potential metrics across four domains (structural, systems or policy level, processes of care, biomarkers and behaviours, and long-term health events and outcomes) and three risk tiers (diagnosed diabetes, high risk for diabetes, and whole population), and prioritised metrics according to their health importance, modifiability, data availability and the degree to which they represent areas of global inequality.

Shedding New Light on the Ageing Process

Scientists from the Trinity Biomedical Sciences Institute (TBSI) have shed new light on ageing processes in the brain. By linking the increased presence of specialised immune cells to conditions such as Alzheimer’s disease and traumatic brain injury for the first time, they have unearthed a possible new target for therapies aimed at treating age-related neurological diseases.

The research, which benefited from a collaboration with experts at the University of Maryland School of Medicine and focused on microglia in the brain and spinal cord, is published today in leading international journal, Science Advances.

Microglia are a unique type of immune cell whose job it is to support nerve cells, defend against invading microbes, clear debris and remove dying nerve cells by engulfing and eating them. Emerging research indicates that microglia can have different

functional responses depending on molecular and biochemical changes occurring within these specialised cells.

In fact, various subtypes of microglia can be distinguished based on a property called autofluorescence. This is the tendency of cells to emit light of one colour after they have absorbed light of another, and it occurs because specific substances inside the cells absorb light. The substances stored in specialised cellular compartments include fat molecules, cholesterol

crystals, metals and other misfolded proteins.

David Loane, Assistant Professor of Neuroscience in Trinity’s School of Biochemistry and Immunology in TBSI is the lead author of the research. He said,

“As the brain ages, these materials build up inside autofluorescent microglia, which increase their autofluorescence as a result. Unfortunately, this accumulation of cellular debris also makes it harder for the microglia to perform their essential garbage

collection tasks in the brain and to prevent neurological injury and neurodegenerative disease.

“In this study we found – in aged animals – that these microglia adopt a unique, dysfunctional state, which has a number of problematic impacts. For example, there is an increase in cellular stress and damage, an accumulation of fats and iron, alterations to metabolic processes and an increase in production of molecules that over-egg the immune response.”

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Medicine shortages for asthma and hayfever patients

Medicine shortages in Ireland continue to persist with 247 different medicines used by Irish patients currently out-of-stock, as a new trend affecting supply develops, according to the latest Medicine Shortage Index.

The latest figures show the number of medicine shortages in Ireland up an additional 19 medicines in short supply since the end of last month, and a 38% increase since the Index began in October.

Of the 247 medicines currently unavailable, 13 are listed on the World Medical Organisation’s (WHO) ‘critical medicines’ list.

The latest shortages analysis indicates a new trend of medicines that are stored or delivered using plastic components are now increasingly in short supply. These medicines include nasal sprays, inhalers for the treatment of asthma and 11 different eye drop products.

Other medicines still in short supply across multiple suppliers in the past week include those that treat epilepsy, and medicinesused for the treatment of high blood pressure.

Many antibiotics like Amoxicillin and Penicillin and commonly used over-the-counter medicines like Benylin ™and Dioralyte ™ are still difficult for patients to source.

The Medicine Shortage Index, prepared by industry experts, Azure Pharmaceuticals, analyses data made publicly available by

the Health Products Regulatory Authority (HPRA).

Other European countries have already taken specific policy measures to date in response to the escalating medicine shortage issue. Portugal, the UK, Germany, and Switzerland have all taken a range of price related policy measures in response to the problem, including price increases for lower priced medicines. While, Sweden, Denmark and Malta, which all use tenders to set reimbursement prices, have all experienced price increases due to lack of supply of core medicines. To date, the Irish Department of Health is yet to meaningfully respond to this deepening challenge.

Medicine shortages will continue grow incrementally unless political will is shown in Ireland to take measures, like those carried out by other EU nations, to meaningfully tackle the issue, Sandra Gannon, Azure CEO, said, “One of the means we have to protect our domestic supply of stock, to prevent these important medicines from running out, is through pricing. Other European countries have already recognised this fact and taken measures to mitigate against situations where

their stocks run out. For example, Portugal recently raised its pricing by up to 5% for cheap medicines.

“Weaknesses in the supply chain alone highlight the imperative of revisiting the pricing framework for medicines to protect supply of stock and protect Irish patients.”

Commenting on the perception that medicine shortages are a result of exceptional circumstances and are a one-off situation, Ms Gannon pointed to the level of EU activity on the topic, as well as the focus of the European Medicines regulator (EMA) on medicine shortages as evidence that this problem is not going away without serious intervention and planning.

“There’s an awareness in other European countries that market related factors need to be tackled. Medicines shortages are not just winter specific, and shortages are not only occurring as a result of exceptional circumstances. There are systemic factors that need resolution.

“Each patient has different needs and reducing the problem down to exceptional circumstances alone diminishes the quality of life impact that each patient experiences with their illness.”

Skin Cancer Prevention

The Minister for Public Health, Wellbeing and the National Drugs Strategy, Hildegarde Naughton, has launched the National Skin Cancer Prevention Plan 2023-2026.

Skin cancer is the most commonly-diagnosed cancer in Ireland, with around 13,000 new cases every year. This number is projected to double by 2045. However, the majority of cases can be prevented by following skin protection behaviours. Developed by the National Cancer Control Programme in partnership with Health Ireland, the National Skin Cancer Prevention Plan 2023-2026 was completed in consultation with cancer charities, healthcare professionals and national organisations representing priority groups.

It builds on the foundations of public awareness created via the original plan which ran from 2019 to 2022.

It includes a number of actions designed to target specific groups which have been identified as being particularly vulnerable to UV damage.

These include children and young people, outdoor workers and those who participate in outdoor leisure activities as well as sunbed users.

Its core messages will be amplified through HSE’s annual SunSmart communications campaign which uses a range of platforms to provide targeted key messages about skin protective behaviours.

Minister Naughton said:

“Skin cancer is the most commonly diagnosed cancer in Ireland, but it is also largely preventable and we can all significantly reduce our risk by adopting practical skin protection behaviours.

“The new Skin Cancer Prevention Plan builds on the excellent work already done to build awareness and it provides a road map to ensure that skin protection becomes part of our everyday routine, and I would like to thank the team in the National Cancer Control Programme for their extensive work on this.

“As well as being the cornerstone of our National Cancer Strategy, cancer prevention embodies the principles of Healthy Ireland.”

Don’t let allergic reactions disrupt your customers’ lives –whether it ’s hayfever, allergic skin rashes or food allergies such as itchy skin, rashes and hives.

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 a ect 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 e ects: 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 e ects, particularly in the young and elderly.

Overdose: Symptoms of overdose likely to be similar to side e ects 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 Haleon group of companies. PM-IE-PIRI-21-00004

Infertility

Making Decisions about Infertility Treatment

Making decisions about infertility treatment – how can pharmacists help before a patient sees the doctor and when should the patient seek medical help? These are common questions often faced by the pharmacy team.

Written by

How is the cause of infertility identified?

Infertility affects men and women equally. Twenty-five percent of infertile couples have more than one factor that contributes to their infertility. In approximately 40 percent of infertile couples, the male partner is either the sole cause or a contributing cause of infertility. Irregular or abnormal ovulation accounts for approximately 25 percent of all female infertility problems. Often infertility issues may arise if the patient has irregular or absent periods, ejaculation issues, a diagnosis of PCOS or endometriosis, prior surgeries or any medical conditions that may complicate conception or pregnancy.

What role can pharmacists play?

prescription is presented, take the patients number and research if the item is available on a particular scheme. Connections via whatapp links and pharmacist forums now gives us the ability to get information from our colleagues in a quick and timely manner. It is a resource that as a pharmacist may be under utilised.

The National Infertility Support and information Group

National Infertility Support and Information Group (NISIG) was founded 26 years and provides support to people around a wide range of fertility related issues including IVF, surrogacy, miscarriage and related issues. We offer support around 4 key pillars:

• Peer to peer support meetings both in person and online

We recently spoke with Pharmacist Sarah Magner and Caitriona Fitzpatrick from the National Infertility Support and Information Group to gain further insight into the vital role played by community pharmacists and their teams in this field.

Infertility is often a lonely and solitary journey and the pharmacist is often one of the few people who are aware that the patient is experiencing infertility. Those under 35 and who have been trying for a baby for 12 months, or over 35 and trying for 6 months should have investigations initiated. This can start with blood tests of which many can be carried out by the patients’ own GP. These include testing for both partners.

Infertility is defined when couples are generally advised to seek medical help if they are unable to achieve pregnancy after a year of unprotected intercourse. Pharmacists are in an unique position to be able to offer advice in areas that can enhance fertility. Smoking cessation is a major service that can aid improved fertility. Smoking can contribute to infertility in both men and women.

Twelve percent of all infertility cases are a result of the woman either weighing too little or too much. It is possible for women with body weight disorders to reverse their infertility by attaining and maintaining a healthy weight. Pharmacists can offer advice and support in weight management. Pharmacists can actively intervene and play a key role in weight management. At the lower level of engagement, they can help patients in selecting an appropriate weight loss medication and counsel them about appropriate use of weight loss medications. At the higher level of engagement, pharmacists alone or in collaboration with doctors and dieticians can work with patients. In the provision of these services, the pharmacist could use point-of-care devices to check parameters such as blood glucose, blood pressure and cholesterol, review the patient health history, assess the patient’s readiness to change an undesirable health behaviour, offer motivational counselling, design a pharmacotherapeutic plan, and monitor the safety and efficacy of weight loss medications.

As both a pharmacist and a patient who underwent treatment abroad the main issues as I see them are access to medications prescribed and an understanding of the dispensing requirements by pharmacists who may infrequently dispense fertility medications.

Prescription from other EU countries are legal and can be dispensed in Ireland without the need to get transcribed by an Irish doctor. High Tech medicines are also covered without the need for a High Tech prescription. This can be achieved by sending the original prescription from the clinic abroad along with a letter from the patients GP stating that they are aware that they are receiving infertility treatment abroad to the High Tech hub.

Often supplements are on the prescriptions and these are mostly covered on government schemes. If in doubt the pharmacist should contact PCRS and enquire.

One example is Co Q 10 supplement which is covered but only if certain brands are dispensed or a certain cost price is achieved. As a pharmacist who underwent fertility treatment, I can say that personal experience has given me a far greater understanding.

If I could offer one piece of advice to my colleagues, it is that infertility is a tough road and when a

• Resources for those going through their treatment and families afterwards including our newly published books and workshops

• Information for members of the public, a helpline and live webchat

• Advocacy and lobbying in relation to legislation and increasing political awareness NISIG are resolute in our mission that, as the national charity at the coalface of fertility issues, we want to see funding for IVF, IUI, TSI and ICSI treatments provided through the public health system. We believe this is crucial to providing equal opportunity to all those seeking to start a family and to bring Ireland into line with other European countries.

Common advice for patients

I would strongly suggest getting support. People can be very empathetic if they know and often a couple or person undergoing IVF treatment choose to keep their IVF journey to themselves. However support groups such as NISIG can be invaluable and it can be much easier to share your concerns with people who have been through or are going through the same as yourself. Peer support cannot be under rated

Caitriona Fitzpatrick, Chairperson of NISIG, National Infertility Support and Information Group

Sarah Magner, Pharmacist, National Infertility Support and Information Group

Infertility

Evaluate the treatments being offered to you. When going through IVF it is often easy to go down the route of alternative or unproven therapies. HFEA are the UK’s independent regulator of fertility treatment and research using human embryo’s. They are also the first statutory body of it’s type in the world. One feature of it’s website is a traffic-light rated list of add-ons which consists of three colours that indicate whether the evidence, in the form of high-quality RCTs, shows that a treatment add-on is effective at improving the chances of having a baby for someone undergoing fertility treatment.

Clinics may request many tests at very high prices in an already expensive process. Speak to your

GP when starting out and you will often find that many test, especially blood tests can be requested by them. This can save both money and time in some circumstances. Is there an ideal ‘mix’ or ‘formula’ for those trying to conceive?

If there was a formula then the process would be a lot easier. Each couple may have different reasons as to why they can’t conceive so unfortunately there is no one thing that works.

There are many suggested supplements and lifestyle inventions, some with little to no clinical evidence. As for progressing to treatment, this also comes in may ways and

National Sexual Health Strategy

can range from IUI to medicated natural cycles to IVF, ICSI, TESI, donor egg, donor sperm, embryo adoption or surrogacy and that is just to touch on a few.

Enjoying the success stories

My favourite success story is my own I’m delighted to say! I have two beautiful little people in my life now, a daughter of 4 and a son who is 8 months. It is easy to look back with rose tinted glasses, but it was tough at the time. Both physically and mentally it takes its toll, and you can look back and gloss over it when you have success. I had seven transfers in order to have my two children and I probably was medicated in some way for three of the last five years in doing IVF treatments.

I was lucky to be a pharmacist as sourcing medication sometimes alone can be a struggle. However I learned that most items are covered but I needed to often confirm this with PCRS. Often a clinic will call or email last minute with a change to protocol and this opened my eyes to being a patient on the other side of the counter. Couples going through IVF are often not just our patients but our colleagues. It is important to remember that not all infertility stories end as luckily as mine did. I know how privileged I am to have two children and it is something I hope remains with me.

For more information about NISIG: www.NISIG.com Twitter and Instrgram @NISIG1 Instagram is @nisig_ireland Email contact@nisig.com

The Minister of State with Responsibility for Public Health, Wellbeing and the National Drugs Strategy, Hildegarde Naughton, has welcomed the publication of the Review of the National Sexual Health Strategy.

Sexual health has been a priority for the Department of Health; the National Sexual Health Strategy 2015-2020 (NSHS) was developed as a core policy under the Healthy Ireland Framework and remains a priority under the Healthy Ireland Strategic Action Plan 2021-2025. Implementation of the Strategy is led by the HSE Sexual Health and Crisis Pregnancy Programme (SHCPP).

Minister Naughton welcomes the convening of the group to work

on the development of the new strategy to be published by the end of 2023 and emphasised the following areas as priorities for consideration:

• improving sexual health information, focussing on positive menstrual health education and awareness, fertility, gynaecology and contraception

• implementing a model of care for STI and sexual health service delivery

• building capacity and meeting demand for HIV PrEP

• further developing and expanding the free contraception scheme for women and the National Condom Distribution Service, to better support people’s contraception and STI prevention needs and recognising the key role of hormonal contraception in treating the adverse symptoms of periods

New donor conception children’s book

The National infertility charity NISIG has launched the final in its series of donor conception children’s books on the “Solo Mammy” journey called A Special Gift- a solo mammy story! These books are a perfect tool for parents who have conceived using either donor egg, donor sperm, or both or who have embarked on the journey as a solo mammy. They are the first Irish books printed to support parents in discussing their donor family story with their child, and are part funded by the HSE.

NISIG Chairperson Caitríona Fitzpatrick said, “I’m really pleased that the final book in the ‘Special Gift’ series is now available. This has been a key project for us as our first time self -publishing children’s books, and the first of their kind in Ireland.

“However, I also want to take the opportunity today to call for discussions to get underway immediately on the future of fertility services in Ireland including public funding for IVF treatment, as announced in Budget 2023. With only 6 months to go before the promised start of publicly funded IVF, there is a need for stakeholder consultation to begin immediately. We are getting a significant number of requests from people who want to know how they can access this treatment and we have absolutely no information to give them. This is frustrating and needs to be addresses now.”

The key issues NISIG are calling for clarity and discussion on are:

1. Who will be eligible to receive this treatment?

2. What clinics will it be available through - will this be nationwide?

3. Will the treatment continue into 2024 and be expanded?

4. What restrictions will be put in place for those applying?

5. How will the application process work and when will it open?

Caitríona added, “Crucially, we would strongly request that the Department of Health include stakeholders to get their input on the roll out of publicly funded fertility treatment. We must get the foundations of this in place very soon to give people certainty. In our view it is neither practical nor sensible for the Department to exclude those who are at the coalface of this issue for over 25 years when planning for a new system in Ireland.”

Ryaltris™ 25 mcg/actuation + 600 mcg/actuation nasal spray, suspension.

Prescribing information

Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.

Presentation: One delivered dose contains mometasone furoate monohydrate equivalent to 25 mcg mometasone furoate and olopatadine hydrochloride equivalent to 600 mcg olopatadine. White, homogeneous suspension.

Uses: In adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis.

Dosage: For nasal use only. Adults and adolescents (12 years of age and over) two actuations in each nostril twice daily (morning and evening). Elderly: no dose adjustment required. Children under 12 years: not recommended. Renal and hepatic impairment: no dose adjustment expected.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Presence of untreated localised infection involving the nasal mucosa, such as herpes simplex. Recent nasal surgery or trauma until wound healing has occurred.

Warnings and Precautions: Instances of nasal ulceration and nasal septal perforation have been reported. Not recommended in case of nasal septum perforation. Patients using Ryaltris™ over several months or longer should be examined periodically for possible changes in the nasal mucosa and for evidence of Candida infection. Instances of epistaxis have been reported. Visual disturbance may be reported with systemic and topical corticosteroid use. Consider referral to ophthalmologist with symptoms such as blurred vision or other visual disturbances as cataract, glaucoma or rare diseases such as central serous chorioretinopathy have been reported after use of systemic and topical corticosteroids. Hypersensitivity reactions, including wheezing, may occur - discontinue.

Immunosuppression: use with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex. Potential systemic effects of corticosteroids include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Hypercorticism and adrenal suppression may appear at higher than recommended dosages or in susceptible individuals at recommended dosages - discontinue slowly. Increased risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis possible with concomitant use with other inhaled corticosteroids. Careful monitoring needed for acute adrenal insufficiency in response to stress in patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids. In patients with asthma or other conditions requiring long term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of symptoms. Somnolence has been reported following administration of Ryaltris™ in clinical studies. Caution in patients operating machinery or driving a motor vehicle. Avoid concurrent use with alcohol or other central nervous system (CNS) depressants. Increased risk of antihistamine adverse effects with concomitant use of olopatadine or other antihistaminic drugs administered via nasal, ocular or oral route. Paediatric population: It is recommended that the height of children receiving

prolonged treatment with nasal corticosteroids is regularly monitored. Contains 0.02 mg benzalkonium chloride in each actuation. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

Interactions: No interaction studies have been performed with Ryaltris™. Any interactions from the combination of olopatadine and mometasone furoate are expected to reflect those of the components taken individually, no pharmacokinetic interaction between olopatadine and mometasone furoate was observed when administered in combination.

Olopatadine: No interactions with other drugs expected. Mometasone Furoate: Cotreatment with CYP3A inhibitors should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects and patients should be monitored. Pregnancy and Lactation: Avoid use during pregnancy unless potential benefit to mother justifies potential risk to mother, foetus or infant. Assess before prescribing in lactating mothers.

Side Effects: Common: dysgeusia, epistaxis, nasal discomfort.

Uncommon: dizziness, headaches, somnolence, nasal dryness, dry mouth, abdominal pain, nausea, fatigue. Rare: bacterial vaginosis, anxiety, depression, insomnia, lethargy, migraine, blurred vision, dry eye, eye discomfort, ear pain, nasal inflammation, nasal mucosal disorder, oropharyngeal pain, sneezing, throat irritation, constipation, sore tongue, laceration. Frequency not known: pharyngitis, upper respiratory tract infection, hypersensitivity (including anaphylactic reactions, angioedema, bronchospasm, dyspnoea), cataracts, glaucoma, increased intraocular pressure and nasal septum perforation.

Pack Sizes: One bottle containing 30ml suspension (240 actuations).

Legal Category: POM.

Product Authorisation Numbers: PA 1543/002/001

Product Authorisation Holder: Glenmark Pharmaceuticals s.r.o., Hvezdova 1716/2b, 140 78 Prague 4, Czech Republic.

Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.

Date of Preparation: June 2022.

*Ryaltris™ is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis1

Challenging the Degrading of New Medicines

Annual Conference assesses innovation pipeline and supportive policies

Proposals from the European Commission to weaken intellectual property rights will degrade the development and delivery of innovative new medicines for patients in Europe, according to the Irish Pharmaceutical Healthcare Association (IPHA).

“Making this a reality, not just for a few wealthy patients, but for everyone, requires a strategic partnership between the State, universities, research institutions and industry. It means ensuring adequate funding from Government is matched with an understanding from industry that there must be value for money in procurement. We need this to protect public funding for new treatments, orphan drugs and initiatives like the new Genetics and Genomics Strategy which I launched in December.”

The appraisal and approval process

IPHA, which represents the biopharmaceutical industry in Ireland, set out its position ahead of its Annual Conference, which took place in Dublin last month and the publication of the new EU Pharmaceutical Strategy later the same month.

It is urging the Government and other EU member states to request the Commission to amend its proposals and to back science, jobs and innovation by supporting the protection of the IP rights that underpin R&D investment and the scaled-up manufacturing of innovative new medicines in Ireland and Europe.

The IPHA Conference heard keynote speeches from Minister for Health, Stephen Donnelly, T.D., Tánaiste, Micheál Martin, T.D. and numerous industry experts. It explored the economic and clinical impacts of innovation, the promise of new technologies in the pipeline and the importance of supportive polices.

IPHA has described the imminent publication of the new EU Pharmaceutical Strategy as a key moment for European competitiveness and Europe’s struggle to regain the ground that it has lost to the US and China for cutting-edge science and investments. IPHA highlighted that:

• In the 1990s, half of all new treatments originated in Europe, that figure is now just one in five.

• In 2002 the US spent ¤2bn more than Europe on pharmaceutical research and development, today the US is spending ¤25bn more.

• Employment in the pharmaceutical sector in China has risen by 800% since 2021.

IPHA understands that the Commission has been motivated to overhaul the EU’s legislative framework for the pharmaceutical industry in a bid to improve affordability and reliable access to new medicines for less well-off member states. It believes that specific measures can be taken to assist these states in their national health systems, rather than changing Europe-wide IP rights.

It said that the biopharmaceutical industry has already brought forward proposals which set out how improving equity of access across the EU can be achieved by well-chosen, targeted initiatives and co-operative industry agreements. Such targeted measures can have an impact in 2024. By contrast, the proposed changes to IP rights would have the immediate effect of degrading the European environment for long term investment and it would be well into the 2030’s before they delivered any potential impact on national health systems.

Giving a keynote speech, Minister for Health Stephen Donnelly discussed the future of

medicines, investment and the appraisal process.

The future of medicines and the need for partnership

Minister Donnelly stated, “Last year I visited the Texas Medical Centre in Houston. I asked the guy running it what the biggest changes were likely to be to patient care over the next decade. It will come as no surprise to any of you that he referenced personalised medicine – the ability to develop and deliver medicines tailored to individual patients, to identify tiny changes in a patient giving several years warning that they might develop a serious disease, and then intervene to stop it happening.

The Minister added that he wanted to see improvements in the transparency of the process and divulged that he has asked the HSE to bring forward proposals in that regard.

“I want to see greater engagement with stakeholders, including patient groups, to ensure that patients are aware of the process and have sight of various steps and timelines,” he said.

“I have asked the HSE to introduce an application tracker on their website, detailing how applications progress. I have also asked the HSE to introduce indicative timelines for a medicine to complete the application/ approval process.”

He added that an Implementation Group is being established between the Department of Health and the HSE to consider and progress the various recommendations contained in the Report as well as other options to improve the process.

“That Group will engage with stakeholders, including patient groups and industry, in seeking to bring about further improvements to the reimbursement process. That Group will also be open to new ideas.”

Future investment

“Of course, an improved and more transparent drug appraisal and approval process only matters if

An Tanaiste Michael Martin TD

“The Framework Agreements on the Supply and Pricing of Medicines 2021-2025 are central to the provision of these medicines and the State is committed to on[1]going investment. “Of course, this must deliver real and tangible value for the taxpayer as well as the patient”

The end of erectile problems? Touch wood.

Sidena. Your new firm favourite.

Sidena 50mg Tablets are now available over the counter in a 4 and 8 pack.

ABBREVIATED PRESCRIBING INFORMATION

Product Name: Sidena 50 mg Tablets.

Composition: Each tablet contains, 50 mg sildena l (as citrate) .

Description: Light blue, round, slightly dotted tablets. Cross breaking notch on one side and marked ‘50’ on the other side. Can be divided into equal quarters. (Only two quarters of the 50 mg is covered by posology).

Indication(s): Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection su cient for satisfactory sexual performance.

Dosage: Adults and elderly: 50 mg taken as needed approximately one hour before sexual activity. Dose may be decreased to 25 mg. Max dose: 50mg once daily. Impaired renal and hepatic function: Sildena l clearance is reduced in hepatic and severe renal impairment. Consider a dose of 25 mg. Dose may be increased step-wise to 50 mg if tolerated. Children and adolescents below 18 years of age: Contraindicated. Use in patients using other medicines: Starting dose of 25 mg with CYP3A4 inhibitors (not advised to use with ritonavir). To minimise postural hypotension in patients receiving and alpha-blocker, stabilise patient rst on the alpha blocker and use a starting dose of 25 mg sildena l.

Contraindications: Hypersensitivity to sildena l or any of the excipients. Concomitant with ritonavir, nitric oxide donors or nitrates in any form, guanylate cyclase stimulators e.g. riociguat. In patients that sexual activity is inadvisable (e.g. severe cardiovascular disorders such as a recent (6 months) acute myocardial infarction (AMI) or stroke, unstable angina or severe cardiac failure). Refer these patients to a doctor. Patients with loss of vision in one eye due to NAION. Known hereditary degenerative retinal disorders. Severe hepatic impairment. Hypotension. Anatomical deformation of the penis. Women. Not intended if no erectile dysfunction.

Warnings and Precautions for Use: First diagnose erectile dysfunction and determine potential underlying causes (e.g. hypertension, diabetes mellitus, hypercholesterolaemia or cardiovascular disease), before considering pharmacological treatment. Consider the cardiovascular status of patients, since there is a degree of cardiac risk associated with sexual activity. Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of sildena l. Most, but not all, of these patients had pre-existing cardiovascular risk factors. Sildena l has vasodilator properties, resulting in mild and transient decreases in blood pressure. Caution: Patients with anatomical deformation of the penis (such as angulation, cavernosal brosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). Advise patients that in case of priapism, prolonged erections (longer than 4 hours) or sudden visual defect, they should stop taking sildena l and consult a physician immediately. Administer to patients with bleeding disorders or active peptic ulceration only after careful bene t-risk assessment, as there is no safety information available. Interactions: Inhibitors of the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route) isoenzymes such as CYP3A4 inhibitors: Itraconazole, ketoconazole, erythromycin, cimetidine, HIV protease inhibitor saquinavir: May reduce sildena l clearance and increase sildena l plasma levels. Consider a starting dose of 25 mg. Strong CYP3A4 inducers e.g. rifampicin may increase sildena l clearance and decrease sildena l plasma concentrations. Grapefruit juice: May give rise to modest increases in plasma levels of sildena l. Nicorandil (Hybrid of potassium channel activator and nitrate): Due to the nitrate component it has the potential to have serious interaction with sildena l. Sildena l potentiates the hypotensive e ect of nitrates. Alpha blocker: Concomitant administration of sildena l may lead to symptomatic hypotension in a few susceptible individuals. Patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildena l treatment. Sildena l potentiates the antiaggregatory e ect of sodium nitroprusside in vitro. Not recommended in patients with a history of bleeding disorders or active peptic ulceration. Not recommended to use with other pulmonary arterial hypertension treatment containing sildena l.

Ability to Drive and Use Machinery: Minor in uence, dizziness and altered vision were reported. Patients should be aware of how they react to sildena l before driving or using machinery. Undesirable E ects: Very common: Headache. Common: Dizziness, visual disorders, visual colour distortion, vision blurred, ushing, hot ush, nasal congestion, nausea, dyspepsia. See SPC for more adverse e ects.

Marketing Authorisation Holder: Rowex Ltd, Bantry, Co. Cork. Marketing Authorisation Number: PA 0711/170/002. Further information and SPC are available from: Rowex Ltd., Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417

E-mail: rowex@rowa-pharma.ie

Legal Category: Not subject to medical prescription.

Date of Preparation: Aug 2022

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

there is funding allocated for new drugs,” said the Minister. “This is something this Government is aware of and has acted on. The combined funding for new drugs in 2019 and 2020 was ¤10m. For 2021 and 2022 it was ¤80m. The full year impact of this ¤80m is ¤135m, which is a clear statement of intent from me and Government. The result was 112 new drugs approved, 35 of which are orphan drugs. This year already there are twenty-seven new orphan drugs undergoing pricing and reimbursement assessment.

“The Framework Agreements on the Supply and Pricing of Medicines 2021-2025 are central to the provision of these medicines and the State is committed to ongoing investment.

“Of course, this must deliver real and tangible value for the taxpayer as well as the patient. We have to ensure that the cost of drugs and medicines remains sustainable and that the economic benefits of innovation are realised for all. As you will all appreciate there are growing and extensive demands for enhanced and additional services across the health system, and notwithstanding the unprecedented investment in services by this Government, we must be cognisant that there are finite resources to work with.”

While Ireland’s pharmaceutical industry is one of the biggest producers in Ireland, our country is nonetheless pretty small, he reflected. “As such, partnerships like Beneluxa are critical, particularly when it comes to new medicines for rare diseases. Together we have secured access to Zolgensma for Spinal Muscular Atrophy and work continues with Libmeldy, a treatment for MLD. This is now under joint assessment for reimbursement, and Les Martin and I are in discussions about the process.

“Staying on the international theme, you are all of course aware of The Pharmaceutical Strategy for Europe, published in November 2020. It’s fundamentally about ensuring safe, affordable medicines for all citizens and patients. It looks to balance this patient-centred approach with protecting the competitiveness and innovative potential of the European pharmaceutical industry.

“I welcome the significant progress that has been made to date including the creation of the Health Emergency Response Authority, the Structured Dialogue initiative and delivery of the Clinical Trials Regulation.

“I know the Commission’s current work on the revision of the general pharmaceutical legislation, and the Orphan and Paediatric frameworks, is of major interest to you all, as it is to Government, and we await the formal publication of the proposal in the coming weeks.

“I expect that the proposal will contain a number of novel policy options to stimulate innovation, including in the area of antimicrobial resistance. These will warrant careful consideration and I know officials in my department will be keen to hear the views of all stakeholders.

“In conclusion, I look forward to continuing to engage with you in the months ahead as we work to ensure that patients in Ireland have timely access to the best medicines, that innovation is fostered and supported and that value for money is secured.”

An Tánaiste, Micheál Martin TD told delegates that as Ireland’s journey has been from one of the poorest countries in Europe, to becoming one of the wealthiest nations in the world, the pharmaceutical industry has been central to this.

“We are now home to nine out of the top ten pharmaceutical companies in the world. We export more than ¤100 billion. More than 42,000 men and women are employed in IDA client companies. We’re home to 90 manufacturing plants, with 50 of them FDA approved. And more than ¤12 billion has been invested in the industry in the last decade alone.

“It is a phenomenal performance, and I am very pleased to take the chance tonight to acknowledge and pay tribute to it.

“My primary responsibility is to look forward and make the decisions necessary to ensure that Ireland’s story continues to be one of expanding opportunity, better health outcomes for citizens, further sustainable economic growth, social solidarity, and strong, skilled employment.

“And I am confident that your industry will continue to be a big part of all of that,” he said.

Quoting Mark Henry, “The Great Big Miracle of Human Progress comes at a cost” – he went on to add, “Irish public health spending has increased 14-fold over the last 50 years and our state expenditure on pharmaceuticals has doubled in just the last ten years, from ¤1.3bn in 2012, to ¤2.6bn in 2022. It now represents one of the largest components of overall health expenditure and with the growth in demand for high tech and increasingly personalised drugs, the pressure for further increased spending is only going in one direction.

“But our successes as a nation notwithstanding, State resources are finite.

“Together, we need to find ways to enable you to continue innovating and bringing these miraculous products into the world, while at the same time ensuring access to them for as many people as possible while maintaining sustainable public finances. I believe that with good faith and mutual respect among all the parties, we can achieve that.

“Two new Framework Agreements on pricing and supply of medicines were signed in December 2021 with you and with your colleagues in Medicines for Ireland, taking us up to 2025.

These were an important step in reducing prices, improving access for patients and ensuring ongoing State investment in new drugs. The Pharmaceutical Strategy for Europe will be another important dynamic, while my colleague the Minister for Health Stephen Donnelly last week published the Mazars Report. I know Stephen talked to you this morning about what we’re doing with this and that you have welcomed publication of the report.

“I am hopeful that the new Department of Health / HSE Implementation Group that he is establishing to consider and progress the Report’s recommendations will get moving quickly.”

Michael O’Connell, IPHA President said, “The biopharmaceutical industry is Europe’s largest hightech industry. It employs 840,000 people and invests ¤42 billion each year in European R&D. We are calling for Government support to unlock its health, innovation and economic potential so that it can compete on a global scale and reverse a trend of so much investment taking place in the US and China rather than Europe.

“At home, IPHA is intent on working closely with the Government, health authorities and health officials in Ireland to shorten the time that it takes to make new medicines available to patients. We welcome Minister Donnelly’s actions upon the publication of the Mazars Report last week, including the establishment of a Working Group that is open to new ideas, where health authorities, patients’ organisations and industry can work together in new ways to improve the delivery of innovative medicines for patients. IPHA look forward to participating in this Working Group.”

Oliver O’Connor, IPHA Chief Executive added, “We must ensure that EU policies support the innovation and IP rights that are required for the development of new medicines. We need robust IP rights to incentivise investment in the development of innovative new medicines and clinical trials aimed at delivering better outcomes for patients with lifethreatening diseases and other serious medical conditions.”

Minister for Health Stephen Donnelly

No ‘Proposals’ for Chief Pharmacy Officer

There are currently no ‘active proposals’ to develop a Chief Pharmaceutical Officer role in the Department of Health, Minister for Health Stephen Donnelly has confirmed.

Free NRT Products

The HSE has announced that nicotine replacement therapies (NRT) are free from local stop smoking clinics as part of a package of supports on offer to people who quit smoking through the HSE QUIT service.

“In this regard a number of proposals and ways to progress the potential extension of the scope of practice of community pharmacists in the short, medium and longer term are currently being considered.

NRT are licensed medicines that safely give lower levels of nicotine to help smokers get through cravings and withdrawal symptoms that can double their chances of quitting for good.

Deputy Róisín Shortall recently asked the Minister if he intends to create such a post during a recent Dáil Éireann Debate.

Answering, he stated, “The Department of Health recognises the key role of Pharmacy in the Community, and the ongoing significant contribution made by this sector to patients and the public, particularly during the pandemic.

“The potential role that pharmacy may play in the development and implementation of future healthcare reform, especially in regard to the aims and vision of Sláintecare, is under consideration. The Department is open to exploring any evidence based appropriately governed services, delivered by appropriately trained professionals which will support this aim.

World Pharmacists Day 2023

on 25 September, FIP announced recently.

At a time when health systems around the world are recovering from the COVID-19 crisis and general consensus is that urgent action is needed if health services are to meet future needs, FIP’s 2023 World Pharmacists Day campaign presents opportunities to increase awareness of pharmacists as an intelligent solution.

The campaign is led by FIP every year, with the theme chosen by the FIP Council, and provides an opportunity to promote the pharmacy profession.

“Beyond doubt, pharmacy is essential to a strong healthcare system and COVID-19 has proven this. But there is a wide range of further needs that pharmacy can provide for to make health systems stronger. Our message is: Let pharmacies do more.

“I encourage colleagues across the globe to prepare to join me in this year’s campaign to celebrate our profession’s achievements in supporting our societies, but also to make its value and further potential in improving health more known,” said FIP president Dominique Jordan.

To answer the specific question, at this time currently there are no active proposals to develop a Chief Pharmaceutical Officer role in the Department of Health. “The Department has professionally qualified pharmacists among its staff. Furthermore a number of units within the Department have responsibility for advancing policy in key areas of our health system. They are cognisant of potential deliverables that can be realised by and through pharmacists and pharmacy services, to deliver patient centred care in line with the vision of Sláintecare.”

In 2022, almost one in five people in Ireland smoke* (Healthy Ireland, 2022). The prevalence of smoking in Ireland remains at 18% and has not declined since 2019.

Dr Paul Kavanagh, HSE Public Health Medicine Lead with the Tobacco Free Ireland Programme, outlines how NRT works. “NRT are safer than smoking because they don’t contain the other poisonous chemicals, like tar and carbon monoxide, which are present in tobacco smoke.

“They come in many different forms like patches, gum, lozenges, inhalers and mouth sprays and often work best when you combine them together in a way that suits you.

“Using NRT, over a full course of 12 weeks, doubles your chances of quitting smoking in combination with all the encouragement, emotional and behavioural support available from HSE Stop Smoking Advisors before and after you quit smoking. I would recommend anyone who is thinking about stopping smoking to consider making a quit attempt with help from NRT and a Stop Smoking Advisor to give themselves every chance of staying quit for good.

“NRT products are checked for safety by the Health Products Regulatory Agency (HPRA) in Ireland, and following a comprehensive assessment by the Health Information and Quality Authority (HIQA), they are recommended as a safe, effective and clinically sound way to stop smoking in the National Stop Smoking Guidelines.”

“Pharmacists strengthening health systems” will be the theme of World Pharmacists Day

Deputy Roisin Shortall

Pharmacy Role in Women’s Intimate Health

Many women present to the pharmacy with symptoms of irritation in the vulvo-vaginal area. Itching, soreness, dryness and discharge can be caused by a number of issues including, but not exclusively, thrush, bacterial vaginosis or genitourinary syndrome of the menopause.

Vulvovaginal candidiasis (thrush) Vulvovaginal candidiasis, or thrush, is the most common cause of vaginitis (inflammation of the vagina) and vulvovaginitis (inflammation of the vulva and vaginal region). Candidiasis is typically caused by an overgrowth of the fungal yeast Candidia albicans. The National Institute of Healthcare Excellence (NICE) states that C.albicans accounts for 80-92% of cases with a number of other fungal yeasts accounting for the remaining cases.

Candidiasis is very common, with 70-75% of women experiencing the condition at least once and 40-50% of women reportedly experiencing it two or more times throughout their lives. It is estimated that Candida species could be isolated from 20% of vaginal swabs form otherwise healthy, asymptomatic women of reproductive age at any one time.

The lactic acid producing Lactobacillus species causes the acidic pH range of the vagina, although the vaginal microbiome is diverse. The composition of the vaginal microflora is dynamic and increased change occurs during menstruation and sexual activity. The majority of women are thought to be colonised with Candida species without symptoms at some point in their lives thus it is thought that the dynamic nature of the vaginal microbiome is a critical factor that leads to colonization by Candida, as well as contributing to it becoming pathogenic.

There are a number of risk factors that have been identified as leading to colonization and/or symptomatic candidiasis:

• Hormonal changes (e.g. pregnancy, combined oral contraceptive pill/ hormone replacement therapy, menstruation.

• Immunosupression (e.g. HIV, corticosteroids)

• Antibiotics (particularly broad spectrum)

• Sexual activity (e.g. sexual intercourse, orogenital contact)

• Diabetes (particularly when poorly controlled as high blood sugar levels lead to better conditions for the yeast to grow)

• Changes in vaginal pH

• Vulvardermatosis

• Genetics

There are a number of typical symptoms and signs of thrush:

• Pruritis

• Cheesy discharge

• Irritation (redness, swelling)

There are a range of OTC products available in pharmacies that pharmacists can recommend after establishing that a woman has presented with symptoms of thrush. Azole creams and pessaries inhibit Candida yeast cells from transforming into hyphae and are available OTC. Oral treatments are available on prescription only.

Pregnancy can increase the chances of women developing thrush. It is not harmful to the baby and can be treated with topical treatments and pessaries. Pregnant women should be advised to return if their symptoms have not resolved within 7-14 days.

Various lifestyle factors may contribute to the development of thrush and the discomfort associated with symptoms. Women should be advised to wear loose-fitting, cotton underwear, to

use fragrance-free and soap-free cleansers and to have showers rather than baths. Advise women to keep their genitals clean and dry as Candida species, like most fungi, thrive in moist, warm environments. Dietary changes such as reduced sugar intake and use of probiotics have been noted to increase the rate of clinical cure and reduce short-term relapse. The effectiveness of probiotics is however, strain dependent.

Bacterial vaginosis (BV)

Bacterial vaginosis is a common cause of abnormal vaginal discharge in women of reproductive age. It is characterized by a white, nonirritating, malodorous vaginal discharge. This discharge commonly smells ‘fishy’ and this odour is often more noticeable after sexual intercourse. Women who experience repeated episodes of Bacterial Vaginosis may benefit from using lactic acid vaginal gels to facilitate the restoration of the normal vaginal flora. Repeated episodes are more frequent in women who practice vaginal douching. The diagnosis is made clinically on the basis of the description and appearance of the discharge. Typically, the normal pH of the vagina increased from <4.5 to above 4.5 and up to 6.0 reflecting the replacement of normal lactobacilli with anaerobic organisms.

Patients diagnosed with BV should be advised to avoid contributing factors including vaginal douching, use of shower gel in the genital area, and use of antiseptic agents or shampoo in the bath. Patients should also be counselled on smoking cessation and safe sex practices to reduce instances of BV. Goals of treatment include relief of symptoms, reduction

in postoperative infection, and reduction of STIs.

Without treatment, BV resolves spontaneously in up to one-third of non-pregnant and one-half of pregnant individuals. Nonpregnant women who are symptomatic or those undergoing gynaecological procedures or surgeries that involve the vagina should be offered treatment. Non-pregnant women with asymptomatic BV do not usually require treatment. Screening for BV is not recommended as part of regular antenatal care, however if a pregnant woman is incidentally found to have asymptomatic BV, the woman’s obstetrician should be consulted as to whether treatment is appropriate. Pregnant women diagnosed with BV who are symptomatic should be treated.

Nitroimidazole antibiotics are usually prescribed orally to treat BV. Lincomycin is prescribed orally and/or topically. There is no benefit in treating male partners.

Genitourinary syndrome of the menopause (GSM)

Genitourinary syndrome of the menopause (GSM) or vulvovaginal atrophy, results from estrogen loss and is often associated with vulvovaginal complaints e.g. dryness, burning, dyspareunia (pain during sexual activity) and even pain and sensitivity when wiping post urination. Urinary frequency and bladder infections may also occur.

It is important to consider the age of a women when she presents to the pharmacy with symptoms such dryness, excessive watery discharge, burning or pain during sexual activity. Advise on soap free cleansers, vaginal moisturisers and lubricants may be beneficial. These products are widely available OTC in pharmacies.

Women’s Health

The use of locally applied estrogen (either cream, gel or pessaries) in perimenopausal or post-menopausal women can considerably reduce symptoms of GSM. For some women oral or transdermal hormone replacement therapy (HRT) will be required.

Many women with GSM (up to 80%) do not seek medical care or advise so it is important that when a woman presents to the pharmacy that the appropriate questions are asked and that she is referred to her GP when appropriate.

Women’s intimate healthcare is a large and very relevant topic and one where Pharmacists can make a positive and lasting impact on the health of the women they are dealing with every day. By virtue of their patient access, community pharmacists can provide front-line health education and screenings to female patients. Pharmacists can identify women at increased risk for various diseases and help in early detection of disease.

Managing Menopause

The intensity, duration, and type of symptoms a women experiences

News

during menopause depends on a variety of factors. Pharmacists are in a position to identify appropriate strategies to reduce or manage the most bothersome symptoms. Many women experience uncomfortable symptoms as they approach menopause. The hallmark symptom is the hot flash (also called the hot flush). This sudden feeling of intense warmth in your face and chest is followed by skin redness (flushing) and heavy sweating. Then it ends with a cold, clammy feeling. Some women may also have fast heartbeats (palpitations), a feeling of pressure in the head, dizziness, faintness, or weakness.

A hot flash usually lasts from 1 to 5 minutes. Approximately 80% of women suffer from hot flashes before, during, and after menopause. Hot flashes usually occur for 2 to 5 years before they taper off, but can last longer. Some women may never have a hot flash and some may have them for many years.

What is Happening?

Most women have their final menstrual period at about age 50

or 51. It can be said that a woman has reached menopause when she has not had a menstrual period for 12 months in a row. Ovulation stops and they will no longer be able to become pregnant.

The most common symptoms of menopause are:

• Bladder problems

• Hot flashes

• Mood swings

• Night sweats

• Severe tiredness

• Sleep problems

• Stiff painful joints

• Vaginal dryness

These symptoms may disappear within a few months, but sometimes they can persist for several years after the last menstrual period.

As women age, they are at increased risk of developing other health conditions—this is natural. It’s at this time of life that some women develop heart disease, dryer skin, and lack of interest in sex. These problems can be

related to low estrogen levels. Low estrogen after menopause can also cause faster bone loss and increase the risk of developing osteoporosis (“brittle bones”).

Dealing with Symptoms

The best approach to reducing menopause symptoms is to look at the individuals lifestyle and make simple changes.

Many women note that certain things bring on hot flashes, or make them worse. These are called “triggers.” Advise them to pay attention to what is happening before and during these hot flashes. Once they identify things that cause or contribute to them, they can avoid them. Some may find that hot drinks, hot or spicy foods, alcohol, caffeine, cigarette smoking, stress, hot weather, or a warm room may trigger a hot flash.

Exercise regularly. Exercise reduces stress, decreases the risk for heart disease and diabetes, helps to preserve bones, and can help get a better night’s sleep.

Those who are overweight, should try to shed a few pounds. Lighter women seem to have fewer symptoms.

OPTASE® TTO BlephaWipe: Opening doors to a greener future

Scope Eyecare launches new OPTASE® TTO BlephaWipe; a preservative free eyelid cleansing wipe that are 100% biodegradable.

Scope, a leading provider in eyecare, is proud to announce the launch of OPTASE® TTO BlephaWipe which will supersede their current eyelid cleansing wipes - OPTASE® TTO Wipes.

OPTASE® TTO BlephaWipe’s are designed to provide relief for people suffering from Dry Eye, MGD (Meibomian Gland Dysfunction), and Blepharitis, conditions that affect the health of the eyelids and can cause discomfort and irritation. One of the primary benefits of OPTASE® TTO BlephaWipe is its formula, which contains Tea Tree Oil (TTO). TTO has been used for centuries as a natural remedy for a variety of ailments and is known for its anti-bacterial and anti-inflammatory properties. In the context of eye care, TTO can help to reduce inflammation and relieve discomfort associated with conditions such as Dry Eye, MGD, and Blepharitis. OPTASE® TTO BlephaWipe’s are also infused

with other natural ingredients such as Aloe Vera and Chamomile, which help to soothe and moisturize delicate skin around the eyes.

Unlike OPTASE® TTO Wipes however, OPTASE® TTO BlephaWipe’s are now made with sustainable and biodegradable materials, making them an ecofriendly choice for consumers. With the addition of OPTASE® TTO BlephaWipe to the OPTASE portfolio, Scope’s Senior Product Manager Féidhlim Dervin had this to say; “Our mission at Scope is to provide innovative, effective and easy-to-use solutions that allow people to take better care of their eyes. As a company, we are also committed to reducing our impact on the environment and offer more sustainable solutions to our customers. We understand the importance of preserving the planet and believe that small changes can make a big

difference. We are proud to bring OPTASE® TTO BlephaWipe to the market and see this as a major step forward in our company’s sustainability journey.”

To ensure a seamless transition over to the new biodegradable wipes within pharmacy, the barcode, pack dimensions

and price of OPTASE® TTO BlephaWipes will remain the same as that of OPTASE® TTO Wipes. If you’d like to hear more, you can freephone Scope on 1800 816 005, visit their website at www.scopeeyecare.com or reach out to your local Business Development Manager.

“You are what you eat”

The gut microbiota and cardiometabolic disease

Written by Gaston L. Cluzel1, Noel M. Caplice2 1PhD Student , APC Microbiome Ireland | 2Professor Cardiovascular Sciences, Cardiologist, PI APC Microbiome Ireland - University College Cork, Cork University Hospital

Cardiovascular disease (CVD) is the leading cause of mortality worldwide, accounting for a third of total annual death. The combination of obesity related disorders and cardiometabolic disease has now reached epidemic proportions, threatening to overwhelm healthcare services in the developed industrialised world. Current strategies for fighting symptomatic cardiometabolic disease rely heavily on labour intensive surgical procedures or drugs with limited efficacy and potentially hazardous secondary effects. Therefore, new thinking and treatment approaches are urgently required to fight CVD in the midst of the current metabolic syndrome pandemic.

The human gut is inhabited by a rich community of trillions of microorganisms known as the gut microbiota. The presence of these bacteria, yeasts, viruses and protozoa inside the human body is a consequence of millions of years of co-evolution, during which microorganisms have adapted to take advantage of the sheltering environment that is our gut. The gut microbiota as a “super-organism/ organ” has developed strategies so as to be immune-tolerated by our body. The host (our body) enjoys the fruits of these commensal microorganisms since they offer a protection against pathogenic

gastrointestinal infections, improve digestion and provide key macro and micronutrients essential for health. However, the gut microbiota must be tightly controlled by our body since changes within this microbial community may initiate health disorders.

Recent research has identified a strong link between the gut microbiota and cardiovascular health, shedding light on a novel and promising field of potential intervention for CVD patients. Indeed, the gut microbiota not only plays a critical role in regulating physiological processes such as digestion, metabolism and immune response but can be considered as a hidden but essential metabolic organ. For instance, alteration in the gut microbiota, a phenomenon known as “dysbiosis”, has been associated with health disorders such as gastrointestinal disease, metabolic syndrome and systemic inflammation - all of which can contribute to progression of CVD. Therefore, manipulating the gut microbiota could constitute a reliable strategy for fighting cardiometabolic disorders.

The gut microbiota lies at the interface between our diet and our intestine which is the largest human immune interface (6 metres long) with the external environment. It is directly exposed

to our daily dietary habits and can change its composition within days of exposure to a poor diet. Moreover the proximity of the gut microbiota to the gut lining means signaling between this organ and the human body is continuous with potential for good and bad outcomes. Certain diets promote a healthy microbiota that in turn benefits our gut health and by extension the general health of the host. For instance, the “Mediterranean” diet - rich in plant-based ingredients, nuts and fibre - is associated with a thriving microbiota rich in beneficial bacterial species. This type of diet has also been shown to promote weight loss and reduces the cardiovascular effects of obesity and metabolic syndrome. On the other hand, a “Westernised” diet rich in fats, sugars and processed ingredients leads to dysbiosis with a microbiota depleted of beneficial bacterial species and is typically associated with obesity and cardiometabolic related disorders. Beyond diet, certain food components appear to be particularly efficient in shaping the gut microbiota and promoting health. Dietary fibre and certain prebiotics are not digested by the body but instead are fermented by the gut microbiota, promoting the growth of beneficial bacterial species. Initiating their beneficial effect on the microbiota prebiotics also improve host health and may be a modifier of CVD risk. Indeed, clinical studies have found that prebiotics can promote weight loss, improve lipid profiles, reduce low grade inflammation, and improve insulin sensitivity, all of which are risk factors for CVD. Moreover, reports from preclinical studies suggest that prebiotics may tackle some of the root mechanisms of CVD by preventing cellular and metabolic events that precede full blown CVD. It is also possible to intervene on the microbiota directly using bacteria or yeast preparations, enriched for chosen beneficial species, to colonise our guts. Probiotics are described as live microorganisms that can provide health benefits when consumed

in adequate amounts. Probiotics can also be combined with prebiotics in an attempt to obtain a greater effect than individual components; this is called a synbiotic treatment. Probiotics and synbiotics exhibit numerous health benefits and have been shown to reduce some CVD risk factors in clinical studies. Finally, it is also possible to colonise patient’s microbiota with the microorganisms of a healthy donor. This technique is called faecal microbiota transplantation (FMT) and its success could reside in the transfer of beneficial microbiota properties from donor to patient. FMT has been most successful in treating gastrointestinal disease driven by clostridium difficle. While this technique is still experimental in other diseases, early studies have shown promising results in reducing inflammation and improving metabolic health, paving the way to clinical trials in the near future.

Although microbiota-targeted strategies show promising results in preventing CVD and other disorders, there is still a vast chasm in our knowledge deficit within this emerging field of research. The gut microbiota is an incredibly diverse environment composed of trillions of organisms with vast numbers of different species interacting at a protein, carbohydrate, complex sugar, amino acid, fatty acid and hormonal level. This complexity makes mechanistic interpretation of microbe-host interactions very difficult to decipher short of reductionist methods on one hand or machine learning tools on the other. Moreover, each human being has a unique microbial signature that evolves constantly throughout our life having been hardwired as early as neonatal life with respect to training of the host’s immune system. Therefore, the major challenge of this field does not reside in the capacity of gut microbes to prevent CVD but rather in our ability to harness their power reliably at the scale of human populations.

In response to this challenge, current biomedical research

Gaston Cluzel

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Cardiology: Gut Health

strives to decipher the core mechanisms that rule the interactions between host and gut bacteria. As discussed above gut bacteria are involved in several biological processes participating in the maintenance of cardiovascular health. Here are some major concepts involved in understanding the interaction between the gut microbiota and cardiovascular organs

Intestinal permeability: The outer cellular layer of our body that is in direct contact with our intestinal content is called the intestinal epithelium. The major role of epithelium is to absorb nutrients while constituting an impermeable barrier to gut microbes. It has been repeatedly observed that patients suffering from cardiometabolic disorders suffer from a derangement of this intestinal barrier, a phenomenon called intestinal permeability. This process is explained by the weakening of the tight connections between epithelial cells as well as reduction in the protective mucous layer that lines the gut epithelium. As a result, gut bacteria or surface constituents of bacterial membranes/capsules enter into contact with the deeper cellular layers of the intestine, triggering immune defences and contributing to local tissue inflammation. It is still not clear how this phenomenon is initiated but studies suggest that an altered gut microbiota could more easily escape these defences and breach the gut permeability barrier.

Systemic inflammation: Obesity and cardiometabolic syndrome are associated with elevated levels of pro-inflammatory molecules in the blood, a phenomenon called

systemic low grade inflammation (LGI). This effect is likely a direct result of spill over from local activation of inflammation within the gut mucosa. LGI can lead to activation of immune responses in distal organs including the liver, heart and vascular system. Systemic inflammation appears to be central in this interaction between dysbiosis and end organ disease in the case of CVD.

Microbial lipopolysaccharides (LPS): LPS are highly inflammatory bacterial toxins found on the cell walls of gram-negative bacteria. The presence of LPS in the systemic circulation is called endotoxemia, and has been detected in obese subjects especially in the presence of metabolic syndrome, suggesting that bacterial components may cross the human intestinal barrier to reach the circulation. Moreover, “Westernised” diet that promotes gut dysbiosis is also associated with an increased proportion of LPS producers within the gut microbiome. The immune response to LPS has been shown to contribute to systemic inflammation and activate CVDrelated biological mechanisms in heart tissue and blood vessels.

Microbial products: gut bacteria ferment food components into secondary products. Short-chain fatty acids (SCFAs) for instance are produced from dietary fibre fermentation. SCFAs support intestinal barrier function by promoting epithelial cell growth. The beneficial effects of these molecules also reaches into the cardiovascular system due to their anti-inflammatory and metabolic properties. CVD is associated with reduction in these beneficial

SCFAs at an intestinal and systemic level.

The above concepts connect dietary habits to cardiovascular health through their respective ties to the gut microbiota and the immune system. Maintaining a good microbiota through dietary intervention therefore promotes intestinal barrier function protecting against systemic inflammation and in turn, against CVD.

The clinical potential of microbiotatargeted interventions is only emerging and remains to be fully proven in preclinical gain and loss of function studies to nail down specific biological mechanism(s). The precise factors and interactions between microbiota and gut must be identified in order to develop reliable therapeutic tools. So far, several promising cardiovascular targets have been found that may be modulated as targets for gut microbiota intervention.

NLRP3 (NOD-like receptor family, pyrin domain containing 3): The NLRP3 pathway belongs to the innate immune system response. Upon activation, NLRP3 releases pro-inflammatory cytokines that have been shown to promote CVD processes such as cellular hypertrophy and death. NLRP3 activation has been linked to cardiac remodelling in heart failure and atrial fibrillation. NLRP3 activation has been found to be increased following gut microbiota alteration and endotoxemia. Interestingly, the activation of NLRP3 in atrial fibrillation has been attributed to increased circulating LPS originating from age-related microbiota dysbiosis.

TLR4 (Toll-like receptor 4): TLR4 is a key receptor of the

innate immune system for recognizing microbial products such as LPS. Increased TLR4 activation has been shown to contribute to CVD progression such as atherosclerosis, that can be attributed to increased endotoxemia.

TNFR1 (Tumour necrosis factor receptor 1): TNFR1 is a receptor for a major pro-inflammatory cytokine TNF-α. Increased TNFR1 activation has been associated with cardiovascular disorders such as atherosclerosis, heart failure and atrial fibrillation. TNFR1 activation has been shown to increase with systemic inflammation originating from the gut.

Several inflammatory targets appear to be involved in CVD progression following gut microbiota alteration, and all of these factors and their cognate receptors appear to have amplified activity within the end organs implicated in CVD. Therefore, future gut microbiota-targeted intervention should aim at reducing the source of inflammatory signals from the gut that trigger the activation of inflammatory receptors in the cardiovascular system. These future studies will include preclinical models where reductionist approaches can identify necessary and sufficient pathways for microbiota-CVD interaction, machine learning approaches that interpret the complex interplay between diverse microbial constituents in the gut and therapeutic approaches that go beyond current crude live bacterial therapy to druggable products that result from mechanistic mining of the microbehost interaction in the gut.

Finally, insights from latest clinical and pre-clinical research in the field of the gut microbiota point toward a more holistic approach to CVD in general. Cardiovascular disorders in the past half century appear to be manifestations of a more general societal disease state that can be traced back in part to gut microbiota alteration and industrial food production and dietary habits. Therefore, modern clinical engagement with CVD should not only include conventional risk factor modification and therapies but new approaches to diet that incorporate a more sophisticated understanding of the interaction between food, gut microbiota, host intestinal permeability, low grade inflammation and cardiovascular disease progression

As a closing remark, we can note that the concept “We are what we eat” becomes literal when considering this microbial community as a part of us and of our cardiovascular wellbeing.

Joining Standards of Excellence & Innovation

The Irish Pharmacy Awards 2023

“There are no secrets to success. It is the result of preparation, hard work and learning from failure”

In launching the tenth annual Irish Pharmacy Awards, we are seeking to uncover those individuals and teams putting in the groundwork quoted above to the enhancement of community pharmacy throughout Ireland.

The Irish Pharmacy Awards represent a unique and high-profile opportunity to celebrate the excellence and amazing achievements of Ireland’s pharmacy professionals, and reaffirm IPN’s commitment to the core pursuits of pharmacy excellence in health and innovation.

The Awards recognise outstanding examples of high standards, best practice, innovation and excellence.

It has been, and continues to be, the goal of Irish Pharmacy News to recognise the exact added value of the contribution made by community pharmacists and their teams.

Through the submissions to these Awards and the examples of innovation that they demonstrate, IPN want to inspire you to think about your role, that of your team and of the community pharmacy profession in which you operate, as a whole.

The 14 Award Categories are inviting entries across a broad spectrum of fields; from innovation and business development, to the rising stars of the profession and the teams and individuals making a difference.

2023 Award Categories:

 Haleon Self-Care Award

 United Drug Business Development (Independent) Award

 Perrigo Superintendent Pharmacist of the Year

 Reckitt Community Pharmacist of the Year

 Uniphar Category Development of the Year Award

 JPA Brenson Lawlor Young Community Pharmacist of the Year Award

 Points of Care Testing Pharmacy of the Year Award

 BOI Payment Acceptance (BOIPA) Innovation & Service Development (Chain) Award

 Viatris Community Pharmacy Team of the Year Award

 McLernons Independent Community Pharmacy of the Year Award

 Théa Pharma OTC Counter Assistant of the Year Award

 Community Pharmacy Technician of the Year Award

 Easolief DUO Business Development (Chain) Award

 Online Pharmacy Retailer of the Year

BOOK YOUR TABLE

Over 650 of Ireland’s pharmacy industry professionals will join us on Saturday, May 27th 2023 at the Clayton Hotel (Burlington Road) Dublin. Don’t miss out on this opportunity to network and celebrate community pharmacy.

This is sure to be a night to remember. Seats and tables are filling up fast. Book your table now to attend Ireland’s premier Pharmacy Awards event. Contact Aoife Jackson via email: aoife@ipn.ie

Updates in Bowel Cancer Awareness

Alcohol and Smoking

While bowel cancer is more frequently diagnosed in those over 65, 1 in 10 cases are diagnosed in the under 50’s, so please don’t assume you are too young for bowel cancer, you are never too young. If you notice any of the below signs and symptoms or notice any changes in your body please go to your GP and get checked.

Bowel cancer - Signs and Symptoms

Screening for bowel cancer

Written by Helen Forristal, Director of Nursing, Marie Keating Foundation

Colorectal cancer, often referred to as bowel cancer is cancer that appears in the colon (large bowel) or in the rectum (large bowel closest to the anus). It is the second most common cancer in men and the third most common cancer in women in Ireland. Colorectal cancer is the third leading cause of cancer death women and men.

Bowel cancer: The facts

• In Ireland, around 2562 people each year develop cancer of the bowel, also known as colon, rectal or colorectal cancer.

• Bowel cancer affects both men and women, 1,467 are men and 1,095 are women.

• The risk increases with age - usually diagnosed in people over age of 55 but can occur in people under 50 years of age.

• When caught at its earliest stage, 65% will survive for + 5 years.

Risks and causes of bowel cancer

The causes of most cases of bowel cancer are still unknown but research is going on all the time to establish why some people develop this disease. Researchers have already found several risk factors that may increase your chances of developing bowel cancer. These include:

• Age - Most people who get bowel cancer are over 50. The majority of cases are diagnosed in individuals aged 70 or older, but we know people under 50 are also being diagnosed with bowel cancer.

• Diet - The incidence of bowel cancer is higher in countries that have a low intake of fibre and a high intake of fat and processed meats.

• Family history - a family history of bowel cancer (at least two close relatives) may increase the risk of getting bowel cancer. Risk is higher if diagnosed at a young age.

• Inherited conditions - Familial adenomatous polyposis (FAP) is one of these conditions. FAP is responsible for 1 in 100 cases (less than 1%) of all bowel cancers. Lynch Syndrome, or hereditary nonpolyposis colon cancer, people with this alteration in genetics are at higher risk of colorectal cancer.

• Bowel diseases - people who have had ulcerative colitis or Crohn’s disease for a long time also have an increased risk of developing bowel cancer. Ulcerative colitis and Crohn’s disease are diseases of the lining of the bowel.

• Blood in, or on the poo (stool or bowel motions) - the blood may be bright red or dark in colour.

• A change in normal bowel habits such as diarrhoea or constipation for no obvious reason, lasting longer than six weeks.

• Unexplained weight loss.

• Pain in the abdomen or rectum (back passage).

• A feeling of not having emptied your bowel properly after a poo (bowel motion). Other diseases apart from bowel cancer can cause all the above symptoms. However, if you experience any of these symptoms make an appointment with your GP to get checked out.

How you can reduce your risk of bowel cancer

Bowel health is important. It may help to reduce your risk of developing bowel cancer if you eat:

• More fibres from cereals, beans, fruit and vegetables.

• Less fat including fatty meats and dairy foods.

• More poultry such as chicken and turkey, and fewer portions of red meat.

• Less cured and processed meat such as bacon, sausages and ham.

• More oily fish such as mackerel, salmon, tuna and sardines.

• Less sugary and fatty processed foods such as cakes biscuits and chocolate.

You can also reduce your risk by:

• Doing at least half an hour of moderate physical activity five times a week. The more active you are, the more you cut the risk of bowel cancer.

• Keeping a healthy weight.

• Drinking less alcohol. The less alcohol you drink, the lower the risk of bowel cancer and many other cancers and diseases.

• Being a non-smoker. If you smoke try to quit.

If a member of your family has been diagnosed with bowel cancer you should consult your doctor who may suggest a simple test to detect blood in your bowel motions (stools). There is more information on this test, called a FIT, to follow.

Remember, early detection of the disease is your best chance of a cure.

Bowel screening aims to find bowel cancer at an early stage in people who have no symptoms. It is done with a simple home test called a FIT (faecal immunochemical test) which looks for tiny, invisible amounts of blood in your poo (stool). The poo (stool) test does not tell you if you have bowel cancer but it might tell you that you need more tests, such as a colonoscopy. A colonoscopy is an examination of your bowel using a camera on the end of a thin flexible tube to look for any signs of disease in the lining of your bowel. A small sample of the lining of your bowel (biopsy) may be taken to look at more closely.

Bowel screening may also find other changes in the bowel, such as polyps, which are small growths that are not cancer but, if not removed, might turn into cancer. If polyps are found, they can be removed easily.

BowelScreen - The National Bowel Screening Programme offers regular, free bowel screening to men and women aged 60 to 69. You should receive a letter every two years. If you are not already registered and you have reached your 60th birthday, you can register online or Freephone 1800 45 45 55. Bowel screening involves a free, quick, easy-to-use home test every two years while in the age-range. You simply collect a poo sample on a sampling stick provided in your test kit and send it back to Bowel Screen for analysis.

Screening results

Once you have sent your sample to BowelScreen, you will get a letter with the results in approximately four weeks. Most people will have a normal result. If your results are not normal, this means that blood was found in your poo sample. It does not necessarily mean that you have bowel cancer but it does mean that you may need to have a colonoscopy.

Treatment for bowel cancer

Treatment depends on the size (stage) of the cancer and where it is in the bowel. The main treatments for bowel cancer includes surgery, chemotherapy, biological therapy, and radiotherapy. It is important that you discuss your treatment with your doctor and let them know if you have any questions or concerns. A team of experts (Multi-Disciplinary Team) will discuss the best treatment for you.

This Bowel Cancer Awareness Month the Marie Keating Foundation are urging people to have #NoRegrets with their April campaign.

If you notice any of the signs and symptoms

Or you have any concerns about changes in your body.

Have #NoRegrets, contact your GP and get it checked.

For more visit mariekeating.ie/noregrets

We would like to send our sincere thanks to our campaign sponsors Servier.

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PRODUCT INFORMATION ellaOne® 30 mg film-coated tablet (ulipristal acetate). Refer to the SmPC for further information. INDICATION: Emergency contraception (EC) within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. DOSAGE: one 30mg tablet taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure. Another tablet should be taken if vomiting occurs within 3 hours of intake. Can be taken at any time during the menstrual cycle. Not recommended for women with severe hepatic impairment. CONTRAINDICATIONS: Hypersensitivity to the active substance or excipients. SPECIAL WARNINGS AND PRECAUTIONS: Occasional use only. Use reliable barrier method after use until next menstrual period. If next menstrual period is delayed >7 days or is abnormal or suggestive symptoms occur then perform pregnancy test. Consider ectopic pregnancy. If pregnancy confirmed, woman should contact their doctor. Concomitant use with EC containing levonorgestrel not recommended. Does not contraindicate the continued use of regular hormonal contraception but reliable barrier method should be used until next menstrual period. Not recommended in severe asthma treated by oral corticosteroids. Concomitant use of CYP3A4 inducers [e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John’s wort), rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine] not recommended (may decrease efficacy of ellaOne). Long term use of ritonavir not recommended. Not recommended for women who have used enzyme-inducing drugs in the past 4 weeks. Non-hormonal emergency contraception (i.e. a copper intrauterine device (Cu-IUD)) should be considered. Contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Contains

less than 1 mmol sodium (23 mg) per vial, essentially ‘sodium free’. FERTILITY, PREGNANCY AND LACTATION: Not intended for use during existing or suspected pregnancy. Limited human data does not suggest safety concern. Does not interrupt existing pregnancy. No teratogenic potential was observed; animal data insufficient with regard to reproduction toxicity. Marketing Authorisation Holder maintains a pregnancy registry (www.hra-pregnancy-registry.com) to monitor outcomes of pregnancy in women exposed to ellaOne®. Patients and health care providers are encouraged to report any exposure. Ulipristal acetate is excreted in human breast milk; breastfeeding is not recommended for one week after intake. Breast milk should be expressed and discarded. A rapid return of fertility is likely following ellaOne use; regular contraception should be continued or initiated as soon as possible; subsequent acts of intercourse should be protected by reliable barrier method until next menstrual period.

UNDESIRABLE EFFECTS: Always consult the SmPC before prescribing. Only the most common side effects and those which are rare but may be serious are listed below. Most commonly reported adverse reactions: headache, nausea, abdominal pain and dysmenorrhea. Common (≥ 1/100 to <1/10): mood disorders, dizziness, vomiting, abdominal discomfort, myalgia, back pain, pelvic pain, breast tenderness and fatigue. Rare (≥1/10,000 to <1/1,000): ruptured ovarian cyst.

MARKETING AUTHORISATION HOLDER: Laboratoire HRA Pharma, 200 avenue de Paris 92320 Châtillon - France. MARKETED IN IRELAND BY: Chefaro Ireland DAC, The Sharp Building, 10-12 Hogan Place, Dublin 2, D02 TY74, Ireland MARKETING AUTHORISATION NUMBER(S): EU/1/09/522/003. LEGAL CATEGORY: Medicinal product not subject to medical prescription. Date of last revision of text: March 2023. Unique ID: IE/ELLA/0295.

REFERENCE: 1. Glasier A et al. Lancet 2010; 375 (9714): 555-62.

CPD

60 Second Summary

From September 2022 contraception has become free in Ireland for women between the ages of 17 and 25. The government scheme was allocated ¤9 million in the 2022 budget under the Women’s Health Action Plan 2022-2023, which aims to improve all areas in women’s healthcare.

Emergency contraceptives (EC) are a type of birth control that is used to prevent pregnancy after unprotected sexual intercourse or when other forms of contraception have failed. ECs are sometimes referred to as the «morning-after pill» or the «day-after pill.» There are several different types of ECs available, each with its own method of action and recommended dosages.

Ulipristal acetate pill (ellaOne®) is an orally-active synthetic selective progesterone receptor modulator. It is effective up to 120 hours (5 days) after unprotected sexual intercourse or contraceptive failure but is most effective the sooner it is taken. ellaOne® is highly effective, with a reported efficacy rate of 99.5% when taken as soon as possible after unprotected sexual intercourse.

Levonorgestrel contains a synthetic form of the hormone progesterone (levonorgestrel). LNG should be taken as soon as possible, preferably within 12 hours after unprotected intercourse, and no longer than 72 hours (3 days) after unprotected sex.

Copper intrauterine device (CuIUD) is a small, T-shaped device that is inserted into the uterus by a healthcare professional. It works by preventing fertilization or implantation and can be used up to 5 days after unprotected sex. It also provides ongoing contraception for up to 10 years. If fertilisation does occur, the copper IUD also makes it difficult for the fertilised egg to implant in the uterus.

AUTHOR:

Written by

Duarte Nunes da Silva, Managing Supervising Pharmacist, McGreals

Pharmacy Group

Hailing from Cascais in Portugal, Duarte Nunes Da Silva has made Ireland his home since starting with McGreals Pharmacy in 2016.

In this current role - as the lead Pharmacist in McGreals Baltinglass, Co Wicklow - Duarte has built strong ties in the town with patients and partners alike.

Hitting the headlines in Jan 2022, having administered 1600 Covid Vaccines - the most in any one pharmacy at that time - Duarte commented “People trust us locally and were happy to be able to receive their vaccinations in the safe and friendly local environment they are used to. “Duarte is the epitome of the “trusted pharmacist” and credits his strong team and the fantastic community spirit of Baltinglass as key factors in his success and growth of the pharmacy footprint locally.”

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

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.

3. PLAN - If I have identified a

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

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

4

Pharmacy Role in Emergency Contraception

Introduction

From September 2022 contraception has become free in Ireland for women between the ages of 17 and 25. The government scheme was allocated ¤9 million in the 2022 budget under the Women’s Health Action Plan 2022-2023, which aims to improve all areas in women’s healthcare. Launched by the Minister for Health, Stephen Donnelly, the comprehensive scheme covers GP consultations, emergency contraception, long-acting reversible contraception (LARCs), IUS and IUDs, contraceptive injections, the contraceptive patch, and combined oral contraception (the pill). Women can choose the contraception that works best for them and their lifestyle without any financial barriers.

While currently the scheme is confined to a small cohort, the Minister for Public Expenditure Michael McGrath announced in the 2023 budget that they are expanding the scheme to make free contraception available from ages 16-30 years. Niall Behan, chief executive of the Irish Family Planning Association (IFPA) commended the scheme as a “major step forward for reproductive health and rights.” The scheme’s already quick expansion suggests a further

step in the right direction for reproductive autonomy and gender equality in Ireland.

The Irish Pharmacy Union (IPU) has called for government to expand the accessibility of the free contraception scheme for young women. The IPU has said that women should be given the choice to access contraception directly from their pharmacist, on foot of a structured consultation. This will provide women with even more options to safely and effectively manage their reproductive health and wellbeing.

Speaking on International Women’s Day pharmacist and Chair of IPU’s PCC Committee Kathy Maher explained the benefits of expanding choices to women. “Pharmacies are easily accessible and located in practically every town and village in the country. Women can visit their pharmacy at times that suit them in evenings or weekends. Women should have the choice to avail of this convenience to access contraception.”

Many women already opt to access emergency hormonal contraception through pharmacies, explained Ms Maher. “Pharmacists are experienced at providing contraceptive care and have been safely providing the emergency contraception, over the counter since 2011. The profession is

trained and has the experience to review patients to determine if it is safe to dispense contraception without referring to a GP.

“Pharmacists experience has taught us that many women prefer to access contraception from their pharmacies. Where this is their preference, they should have that choice. This is a view that is now shared by the World Health Organisation who recommended in 2019 that oral contraception should be available without prescription.”

“The introduction of the scheme to offer free contraception was extremely welcome. It is now set to be expanded this year in another positive development for women. However, without enlisting pharmacies this expansion will add further pressure to GPs, while also making it more challenging for women to access the scheme. Better healthcare means using all of our primary care resources effectively. Allowing young, healthy women to access contraception from a range of healthcare providers improves choice and by extension access thus making an important service available to even more women.

Concluding, Ms Maher said, “we are calling on the Minister for Health to revise the new free contraception scheme, providing women the choice to access

40 CPD: Emergency Contraception

the pill in their pharmacies. This should be implemented before the planned expansion of the scheme in the coming months.”

Emergency Contraception

Emergency contraceptives (EC) are a type of birth control that is used to prevent pregnancy after unprotected sexual intercourse or when other forms of contraception have failed. ECs are sometimes referred to as the “morningafter pill” or the “day-after pill.” There are several different types of ECs available, each with its own method of action and recommended dosages.

Since 1st July 2017, medical card holders can get emergency contraception directly from a pharmacy, free of charge, without having to go to their GP for a prescription. Unprotected sexual intercourse encompasses having sexual intercourse: without using a method of contraception or where a method of contraception fails to work.

It is important to note that emergency contraception does not prevent a person from getting a sexually transmitted infection (STI).

According to the World Health Organisation, the following are some examples of what situations emergency contraception can be used in:

• When no contraceptive has been used;

• Sexual assault when the woman was not protected by an effective contraceptive method;

• When there is concern of possible contraceptive failure, from improper or incorrect use, such as:

condom breakage, slippage;

- 3 or more consecutively missed combined oral contraceptive pills;

- more than 12 hours late from the usual time of intake of the desogestrel-containing pill (0.75 mg) or more than 36 hours after the previous pill;

- more than 4 weeks late for the depot-medroxyprogesterone acetate (DMPA) progestogenonly injection;

failed withdrawal (e.g. ejaculation in the vagina or on external genitalia) or precum;

- miscalculation of the abstinence period, or failure to abstain or use a barrier method on the fertile days of the cycle when using fertility awareness based methods.

What types of emergency contraception are available and how effective are they?

There are different types of emergency contraception methods available, including hormonal methods (such as the morningafter pill) and non-hormonal methods (such as the copper intrauterine device (IUD)).

Types of emergency contraception

Hormonal methods:

a. Levonorgestrel pill

This pill contains a synthetic form of the hormone progesterone (levonorgestrel). LNG should be taken as soon as possible, preferably within 12 hours after unprotected intercourse, and no longer than 72 hours (3 days) after unprotected sex.

b. Ulipristal acetate pill (ellaOne®)

Ulipristal acetate is a selective progesterone receptor modulator that prevents or delays ovulation. It is effective up to 120 hours after unprotected sex but is most effective the sooner it is taken. Ulipristal acetate (ellaOne®) has been demonstrated to be more effective than levonorgestrel from 0-120 hours after unprotected sexual intercourse (UPSI) so it should be considered first-line oral emergency contraception unless contraindicated.

Non-hormonal methods:

Copper intrauterine device (Cu-IUD)

This is a small, T-shaped device that is inserted into the uterus by a healthcare professional. It works by preventing fertilisation or implantation and can be used up to 5 days after unprotected sex. It also provides ongoing contraception for up to 10 years. If fertilization does occur, the copper IUD also makes it difficult for the fertilised egg to implant in the uterus.

The Cu IUD which is available in the ROI (under European license) for long term contraceptive protection has a profound and immediate effect on sperm. Within minutes of copper ions

entering the uterine cavity a marked inflammatory response occurs. Leucocytes converge in the endometrium and into the fluid that fills the uterus and fallopian tubes. Levels of prostaglandin also rise. There is a direct toxic effect of copper on both sperm and the ova as well as an impairment in sperm motility. When inserted before fertilisation a Cu IUD will have significant pre fertilisation contraceptive effect. When inserted after fertilisation, the effects of copper on tubal motility and endometrial receptivity will have a significant post fertilisation but pre-implantation contraceptive effect. Once implantation has occurred, copper appears to have no contraceptive effect and so is not considered to be abortifacient in any way.

Statistically speaking, Cu IUD devices are by far the most efficient form of EC and in a review of cumulative data observing 7000 post-coital (emergency) insertions only 6 pregnancies resulted (a failure rate of <.1% or 99.9 % effectiveness is quoted). It has the added advantage of protecting against further episodes of UPSI in the month of insertion and beyond for 5-12 years or more depending on the size and style of the device inserted. The other advantage of a Cu IUD over hormonal methods of EC is that the timing is much wider. Because copper has prefertilisation, post fertilisation and pre-implantation effects (and as implantation is only likely to occur at least 5 days after ovulation) then a copper coil may be placed up to the 19th day of a 28-day menstrual cycle- regardless of what day or how many episodes of UPSI have occurred in that cycle. You can adjust the insertion timing for longer or shorter cycles. That is, if

a woman has had several episodes of UPSI during a cycle, and if her usual cycle is 30 days long, she can have a Cu IUD placed at any time before the 21st day of that cycle (“adjusted day 19”) and have great confidence that an unintended pregnancy will not result. Cu devices can be used in addition to either of the hormonal EC options. If a patient goes on to choose a Cu device after having taken a hormonal EC as long as she is within the “adjusted day 19” time frame or still less than 5 days after the UPSI.

Now there are obvious drawbacks to a Cu IUD for emergency contraception. It can be uncomfortable / painful to have one inserted; although practitioner expertise will play a large part in this. Failure to insert at all is unlikely but a possibility. It may be hard to access copper coils in some parts of the ROI. Many IUD inserting doctors are unfamiliar with sourcing and insertion techniques for copper devices; although the ICGP is trying to improve this. Another issue arises in that some doctors who routinely offer copper devices as an ongoing contraceptive choice do not offer emergency insertion. Money, as always is a big issue in that even where EC Cu IUDs are available; as they are in almost all family planning clinics, the service is currently only free to those aged 17-26 and may not be covered on the GMS. Another counseling point is the possible connection with placing an intrauterine device

A copper IUD is almost 100% effective as a form of emergency contraception.

ADEK BERRY/AFP via Getty Images

through the cervix of a woman who may have just had unprotected sex. If STI exposure is a concern, then close surveillance and screening after IUCD placement will be very important.

Without question though, if a woman is at high risk of conception and wants to avail of the most effective means of post coital contraception than the Cu IUD is the best choice. Ideally all pharmacists should know and share contact information for nearby EC -Cu IUD inserters. How can someone access emergency contraception, and are there any age restrictions or prescription requirements?

Emergency contraceptive pills are available to buy without a prescription and women and people with a uterus aged 17 to 26 can now access emergency contraceptive pills free-of-charge at participating pharmacies.

Since July 1st, 2017, medical card holders in Ireland can also receive emergency contraception directly from a pharmacy free of charge. This helps ensure that cost is not a barrier to obtaining the medication, which is particularly important for those who may not have the financial resources to pay for it.

How soon after unprotected sex should emergency contraception be taken to be most effective and which type is the most effective?

ellaOne® is one of the emergency contraception options available in Ireland, and contains the active ingredient ulipristal acetate. It is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure, but it should be taken as soon as possible. ellaOne® is highly effective, with a reported efficacy rate of 99.5% when

taken as soon as possible after unprotected sexual intercourse. The medication works by delaying ovulation, which means that it prevents the release of an egg from the ovary. This is achieved by inhibiting the production of hormones that trigger ovulation. By delaying ovulation, the medication reduces the chances of fertilisation and therefore reduces the risk of pregnancy.

Both the Irish Pharmacy Union (IPU) Emergency Hormonal Contraception (EHC) Protocol document and the Faculty of Sexual and Reproductive Healthcare (FSRH) guidance recommend that ulipristal acetate (ellaOne®) should be considered as the first-line oral emergency contraception for women who have had unprotected sexual intercourse within the last five days. This is because it has

Modified from the FSRH Guideline; Emergency Contraception March 2017

Restarting hormone contraception after

been demonstrated to be more effective than levonorgestrelbased emergency contraception. It is important for individuals to be aware of all their options for emergency contraception and to choose the one that is most appropriate for their individual needs and circumstances.

WAIT at least 5 DAYS AFTER USING UPA-EC then restart method of choice. Will be safe again after….

• Diaphragm displacement or removal

(or patch or ring) OR Subdermal progestagen implant (ImplanonNXT) OR Injectable progestagen (Depo-Provera)

Indications: Emergency contraception is indicated in situations where unprotected sex has occurred, including:

• Intrauterine device (IUD) expulsion

Wait an additional 7 days

• Sexual assault or rape

What are the side effects of emergency contraception and how long do they last?

Qlaira COCP Wait an additional 9 days

Desogestrel POP (Azalia or Cerazette) Wait an additional 2 days

Modified from the FSRH Guideline; Emergency Contraception March 2017

• Forgotten or missed contraceptive pills or patch

• Condom breakage or slippage

Emergency contraception (EC) is generally considered safe and effective. However, like all medications, it may cause side effects.

The most common side

of emergency contraception include: changes to your next period

Below is a table of common myths and misconceptions about emergency contraception: Myth/

Emergency contraception can only be taken the ‘morning after’ having unprotected sex

You can only take emergency contraception three times in your life

You are protected against STIs

Emergency contraception is 100% effective

You can only obtain emergency contraception from your GP

Emergency contraception should be taken as soon as possible, but it can be taken up to 120 hrs (5 days) after unprotected sex or contraception failure

Emergency contraception can be taken many times in your life and still be effective. Although it’s not intended as regular contraception. ellaOne® is for occasional use and should in no instance replace a regular contraceptive method

It is important to still get tested for STIs as emergency contraception does not protect against them

Emergency contraception is 99% effective if taken correctly. It is important to keep an eye on your next cycle and take at least one pregnancy test in the coming weeks

Emergency contraception is available from pharmacies following a consultation with a pharmacist

After taking levonorgestrel or ulipristal acetate, it is best to use a barrier method of contraception until the next menstrual period starts Latest

After taking emergency contraception, I am protected until my next menstrual cycle

Some pharmacies offer a ‘click and collect’ service, whereby the woman seeking EHC completes an online form, pays online and then selects a time to come to the pharmacy to collect the medication. The woman is asked to provide a phone number so the pharmacist can contact her and have a consultation prior to her coming into the pharmacy.

CPD: Emergency Contraception

– it can be earlier, later, or more painful than usual. It is advisable for the patient to see their GP if symptoms don’t go away after a few days or if:

• They think you might be pregnant

• Their next period is more than 7 days late

• Their period is shorter or lighter than usual

• They have sudden pain in their lower tummy – in rare cases, a fertilised egg may have implanted outside the womb (ectopic pregnancy)

Nausea: This is the most common side effect of emergency contraception, and it usually lasts for a few hours after taking the medication.

Some women may vomit after taking the medication. Get medical attention if you’re sick within 3 hours of taking ellaOne®, as you’ll need to take another dose or have an IUD fitted.

Headache: Headaches are another common side effect of emergency contraception. The headache usually goes away on its own within a few hours.

Abdominal pain: Some women may experience abdominal pain or cramping after taking emergency contraception.

Fatigue: Some women may feel tired or fatigued after taking emergency contraception.

Irregular bleeding: Emergency contraception can cause changes in your menstrual cycle, including irregular bleeding or spotting.

Breast tenderness: Some women may experience breast tenderness or swelling after taking emergency contraception.

These side effects usually go away on their own within a few days. If you experience severe or persistent side effects, or if you have any concerns about your symptoms, you should speak with your healthcare provider.

As a healthcare professional, it is important to have a thorough understanding of emergency contraception, its indications, contraindications, and side effects to provide effective care and support to consumers who may require this service.

Contraindications:

Emergency contraception is generally safe for most women to use, but there are some contraindications that healthcare professionals need to be aware of, including:

• Known or suspected pregnancy

• Hypersensitivity or allergy to the medication

• Severe liver disease or liver failure

• Current use of certain medications, such as enzymeinducing drugs like rifampicin, carbamazepine, and phenytoin

Contraception after emergency contraception

Ulipristal acetate is an emergency contraceptive that decreases pregnancy risk after unprotected intercourse but does not confer contraceptive protection for subsequent acts of intercourse. Therefore, after using emergency contraception, women should be advised to use a reliable barrier method until her next menstrual period.

Although the use of ulipristal acetate for emergency contraception does not contraindicate the continued use of regular hormonal contraception, ellaOne® may reduce its contraceptive action (see section 4.5). Therefore, if a woman wishes to start or continue using hormonal contraception, she can do so after using ellaOne®, however, she should be advised to use a reliable barrier method until the next menstrual period.

Administration and counselling:

Emergency contraception can be provided by a healthcare professional, including pharmacists, nurse practitioners, and doctors. The choice of method will depend on the individual’s

preferences, medical history, and timing. The healthcare professional should counsel the individual on the importance of regular contraception and the use of condoms to prevent sexually transmitted infections. They should also provide information on potential side effects of the chosen method and when to seek medical attention if necessary.

Women should be advised about all methods of EC available and their effectiveness. They should also be advised that ECs do not provide contraceptive protection for the rest of the cycle, so it is important to avoid sexual intercourse or to use effective contraception after taking them.

Pharmacists should advise women that emergency contraception is not 100% effective. If EC fails and a pregnancy would be a crisis, women still have treatment options and there are supports available. If a woman wants more information or is feeling anxious or confused, she should be advised that the HSE’s dedicated website, MyOptions.ie, is there to help. It may also be appropriate to advise the woman regarding risk of STIs and availability of testing. Take the opportunity to dispel myths and misinformation about ECs during a consultation:

• ECs are safe even for women who cannot normally take hormonal contraception

• ECs do not cause abortion; if a woman is already pregnant, emergency contraception will not displace the pregnancy

• ECs can be taken as often as needed, there is no limit to the number of times they can be used. However, other methods of contraception are more reliable. (NB: information should be provided on more reliable methods if needed)

• ECs have no impact on long term fertility

• ECs do not provide any protection from sexually transmitted infections

As these are sensitive consultations, it is important to have a private consulting room available and a visible sign advertising its availability. Staff should be discreet and should not ask intimate questions where they can be overheard.

paracetamol/caffeine

RECOMMEND FOR FAST RELIEF OF TOUGH PAIN

DUAL ACTIVE FORMULA PROVIDES 30% MORE POWERFUL PAIN RELIEF THAN STANDARD PARACETAMOL1

GENTLE ON THE STOMACH AND NON-DROWSY**

SOLUBLE RELIEF FOR TOUGH PAIN, INCLUDING HEADACHES, PERIOD PAIN AND DENTAL PAIN

FIND OUT MORE AT HALEONHEALTHPARTNER.COM

*compared to standard paracetamol. **when used as directed/always read the label before use.

Reference: 1. Laska EM et al. JAMA 1984; 251(13): 1711-1718.

Product Information: Please consult the summary of product characteristics for full product information. Panadol Extra 500mg/65mg Soluble Effervescent Tablets, paracetamol 500mg, caffeine 65mg. Indications: Relief of mild to moderate pain including rheumatism, neuralgia, musculoskeletal disorders, headache, symptoms of colds and flu, fever, toothache and menstrual pain. Dosage: Adults and children 16 years and over: 2 tablets up to 4 times a day. Do not exceed 8 tablets in 24 hours. You may need a lower dose if you are underweight (<50kg), malnourished, dehydrated or if you have alcohol problems. Children aged 12-15 years: 1 tablet up to 4 times a day. Do not exceed 4 tablets in 24 hours. Do not give to children under 12 years. Minimum dosing interval: 4 hours. Contraindications: Hypersensitivity to paracetamol, caffeine or any ingredients. Precautions: Avoid concurrent use with other paracetamol-containing products. Diagnosed liver of kidney impairment. Patients on concomitant treatment with drugs that induce hepatic enzymes. Patients with depleted glutathione levels or chronic alcoholism or sepsis. Avoid excessive caffeine intake. Caution in those with hereditary sugar intolerance or on a low sodium diet. Should not be used in pregnancy or lactation without medical advice. Caution, due to paracetamol, if administered with flucloxacillin due to increased risk of high anion gap metabolic acidosis. Do not exceed the stated dose. Prolonged use except under medical supervision may be harmful. If high fever, or signs of secondary infection occur or if symptoms persist for longer than 3 days, consult your doctor. Side effects: See SPC for full details. All very rare: Thrombocytopenia, hypersensitivity reactions including anaphylaxis and skin rash, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, bronchospasm, hepatic dysfunction. Frequency unknown: Nervousness, dizziness. When combined with dietary caffeine intake, higher doses of caffeine may increase potential for caffeine related adverse events such as insomnia, restlessness, anxiety, irritability, headaches, GI disturbances and palpitations. Overdose: Immediate medical advice should be sought in the event of an overdose, even if symptoms of overdose are not present. Legal Category: Supply through pharmacy only. MA Number: PA 678/39/10. MA Holder:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24. Additional information is available upon request. Text prepared: September 2022. Contains paracetamol. Always read the label/leaflet. Trade marks are owned by or licensed to the Haleon group of companies. PM-IE-PAN-21-00017.

UK State Pension Opportunity

Significant Opportunity for those who have worked in the UK

There are very few investment recommendations that financial advisers can make to clients that are a gold-plated opportunity to guarantee them income for life in retirement from an A-rated guarantor for a minimal outlay.

Written by Kieran Moore QFA, SIA, Director,Moore Wealth Management Ltd

Moore Wealth Management has been advising the Irish Pharmacy Community for over 20 years with extensive knowledge of the sector. They can be contacted at 086-3801868, kieran@mwm.ie or www.mwm.ie

option allows you to buy back to 2006 or an additional 16 years.

Example

Take John who has 5 years of National Insurance Contributions and now lives in Ireland. As he is currently under the 10 years minimum requirement he has no pension. However he can buy back 5 years to give him the minimum rate pension. This would cost 5 * £163.80 = £819.

He now has the minimum requirement and will receive a pension at retirement age of the following

What to do now?

However, the option to buy a UK State Pension currently exists for anyone who has worked in the UK. We find this criteria is met by many of our pharmacy clients. Owing to the overwhelming amount of interest in this matter we have put the following Q&A together to show you if you can avail of this opportunity.

Who is eligible for a UK State Pension?

To qualify for the minimum UK state pension entitlement you must have 10 years on your national insurance record. This is the UK equivalent of our PRSI contributions. To qualify for the full UK state pension, you need up to 35 years.

What if I don’t have 10 Years of Contributions?

Even if you haven’t worked the required amount of time to reach the minimum 10 years on your UK National Insurance record, you now have the option to make voluntary contributions to increase your record to either bring you up the minimum requirement or to increase your record to bring you closer to the 35 years required for the full state pension.

Do you Need to be UK Resident No, You do not need to be a resident of the UK to avail of the voluntary contributions scheme. Normally you can pay voluntary contributions for the past 6 years with the deadline being the 5th of April each year but the current

Non-residents importantly have the option of paying Class 2 voluntary contributions which are at a much lower cost than UK residents are required to pay. It must be noted, that Class 2 stamps only allow for state pension entitlement and not other benefits like fuel allowance or spouses pension.

Can I claim both the UK and Irish State Pensions?

Yes, you can be paid both the UK and Irish state pensions if you qualify for both based on your respective social insurance record in each country.

What is the rate of payment in the UK

The maximum rate of state pension payment in the UK is £185.15 per week, for this you need 35 qualifying years on your national insurance record. So someone with 10 qualifying years will qualify for:

10/35ths x £185.15 = £52.90 per week

Cost to Buy Back Years

Buying back years under current offer

• £163.80 per year for Class 2 (Non-Resident) - 99% of you will be in this category

• £824.20 per year for Class 3 (Resident)

10/35ths x £185.15 = £52.90 per week or £2,750 per annum for a once off cost of £819 and this is paid until death*

He can of course also buy back additional years to increase this.

*The accuracy of this calculation will be slightly impacted by an overlap in calculations for pre and post-2016 as the number of years needed for the full pension changed from 30 to 35 this year. This would have to be factored in depending on when you were in the UK but the impact will be minimal.

Timeframe

There is a window of opportunity between now and July 31st this year where you can increase your pension entitlement at retirement age by topping up your contributions. There are several supports available from the UK Government so you can assess your entitlement here. https://www. gov.uk/check-state-pension

What is this worth

To buy an income for life equivalent to the minimum UK Pension of £2,750 would cost circa £55,000 on current annuity(income for life) rates. To buy the full amount would cost closer to £235,000.

Our advice is to send in the CF83 Application form to buy back years from abroad. If you are entitled they will tell you and crucially if it’s in on time you will have the option to buy back years to 2006 at Class 2 (nonresident) rates. Make sure this is sent recorded or tracked post and verify arrival. This is too valuable to leave in the hands of the Royal Mail. If you are unsure about any of this contact Moore Wealth Management on the details below for a full pack and brochure on this including all the required forms.

Advice

If you are lucky enough to qualify, this will have a significant impact on your financial planning. Your adviser will need to update financial projections and your cashflow model to factor this in. This will almost certainly have an impact on your current investment allocations as you may be able to de-risk some of your portfolios once you know you have this income guaranteed. Alternatively, with the security of this income you could move into a more riskon scenario.

This opportunity has highlighted for many that they have no proper financial plan in place and that advice to date consisted of collecting financial products with no goal. Your retirement needs a plan mapped out with full cashflow modeling. Anything else is not at the level of the best advice in today’s adviser market.

Deadline

This temporary arrangement to top up your entitlement ends on the 31st July and was recently extended from April 6th due to demand. Recent reports have indicated that there is a 25-week wait time for applications to be processed.

Have you worked in the UK at any stage in your career?

For those who have, there is a window of opportunity between now and the 31st July where you can increase your pension entitlement at retirement age by topping up your National Insurance Contributions.

If you fi t the criteria it would be difficult to find a more valuable piece of advice to help improve the value of your retirement income. This option is time limited and only available temporarily due to recent changes in the qualifying rules for the UK State Pension.

For a detailed explainer showing what you need to do, please fill in your details below.

Deadline

The temporary arrangement to top up your entitlement needs ends on the 31st July so you need to act now to make sure you don’t miss this valuable benefi t

HSE publishes National Service Plan

The HSE has published the 2023 National Service Plan following approval by the Minister for Health Mr Stephen Donnelly, TD.

Shingles and Risk of MI

we will also continue to support Sláintecare reform and finalise design and commencement of initial implementation of the six Regional Health Areas (RHAs) in 2024.

The National Service Plan (NSP2023) outlines the health and social care services to be provided to the people of Ireland this year. The Government has allocated a budget of ¤21.124bn for this purpose, which is 5.7% above last year’s starting budget.

It includes an additional

• ¤240.2m investment in new service developments

• ¤564.5m once off funding for Covid-19 costs

• ¤899.2m to fund increased costs of providing the existing level of service to cover non pay inflation and national pay awards.

The aims of the NSP2023 are to build further on hospital and community services capacity, improve access to services, including women’s healthcare and mental health services, enhance prevention and early intervention work, take forward the work of the Waiting List Task Force, and implement improvements in the security and resilience of critical national infrastructure.

As we work to build back service capacity affected by Covid-19,

Speaking about the HSE’s priorities for 2023, Mr Ciarán Devane, HSE Chairman said, “Supporting the delivery of universal healthcare and delivering the reforms outlined in Sláintecare remain the priorities for the HSE. Waiting lists for scheduled care in hospitals and long waits in emergency departments, particularly for older people and those who have more complex needs, remain a concern and a priority for the organisation. Our reform programme continues to seek to address this, as well as addressing waiting times for mental health and communitybased services, with the ultimate aim of improving the patient / service user experience through innovative initiatives including the ongoing digitisation of our health service.”

Key Priorities for 2023

Hospitals: Additional general acute beds will come on stream in 2023, bringing the total increase since 2020 to 1,179 by end 2023 along with additional critical care beds, bringing the total to 352 by the end of this year.

Community: The Enhanced Community Care Programme (ECC) will continue to roll out nationally to ensure more people can access healthcare in their local community rather than within the acute hospital setting. These measures include the continued development of 96 Community Healthcare Networks, each

World Immunization Week 2023

servicing a population of c.50,000, 30 community specialist teams for older persons and 30 community specialist teams for people living with chronic disease as well as increased access to community diagnostics (up to 240,000 community radiology tests and 266,500 tests across areas such as echocardiography, spirometry and natriuretic peptide blood tests). 23.9million home support hours will be delivered to 55,910 older persons in 2023.

Mental Health: With an additional budget of ¤14.0m in 2023, we will see an increased number of 12,635 CAMHS referrals, a 17% target increase since 2019.

Disability: We will spend an additional ¤25.0m on disability services including over 70,000 additional hours of personal assistant support to people with disabilities and 1,250 new day services placements for school leavers and graduates of rehabilitative training in line with New Directions policy. We will improve the delivery of a range of specialist communitybased disability services and increase service capacity in the areas of day, respite, multidisciplinary, residential and personal assistant services as well as progressing the delivery of the Assessment of Need process in line with legislative obligations. Recruitment: Regarding staffing, the HSE will expand the workforce by +6,000 WTEs in 2023 whilst also ensuring we have recruited approximately 10,500 staff to replace those that will retire or leave during the year. The HSE is addressing complex challenges in workforce planning and recruitment while maintaining focus on strengthening the retention of the existing workforce.

World Immunization Week, celebrated in the last week of April, aims to highlight the collective action needed to protect people from vaccine-preventable diseases.

Under the theme of ‘The Big Catch-Up’, WHO is working with partners to accelerate rapid progress in countries to get back on track to ensure more people, particularly children, are protected from preventable diseases.

2023 is our global opportunity to catch-up on lost progress in essential immunization. We need to reach the millions of children who missed out on vaccines, restore essential immunization coverage to at least 2019 levels, strengthen primary health care to deliver immunization and build lasting protection in communities and countries.

The goal of World Immunization Week is for more children, adults – and their communities – to be protected from vaccine-preventable diseases, allowing them to live happier, healthier lives.

In a recent study published in Open Forum Infectious Diseases, researchers assessed myocardial infarction (MI) risk after zoster infection.

In the present study, researchers examined the association(s) between herpes zoster and the risk of developing MI after infection. They retrieved data from the US Department of Veteran Affairs (VA) corporate data warehouse (CDW). Patients aged 18 or older with a diagnostic history of herpes zoster who received care at the VA from January 2015 to January 2020 were included as cases.

Overall, the study included 2.15 million patients, with 71,912 cases and 2.09 million controls. MI occurred within 30 days in 244 (0.44%) cases and 5,782 (0.28%) controls. The mean age of zoster cases was 71.3, while controls were, on average, aged 69. Most subjects (> 91%) in either cohort were males.

Patients with a herpes zoster history were 1.35 times more likely than controls to develop MI within 30 days post-infection. Those vaccinated with at least one Shingrix vaccine dose were 18% less likely to develop MI post-index date than nonvaccinated cases. No significant differences were observed in MI rates for individuals vaccinated with Zostavax.

A previous history of MI was a significant risk factor for developing MI after the index date. Likewise, a prior congestive heart failure increased the odds of MI by 29%, while vascular disease history was associated with 14% higher odds of MI. Immunosuppressive conditions increased the odds of developing a MI by 63%.

Further, the male gender was associated with 40% higher odds of MI. Taken together, the findings suggested that herpes zoster infection was associated with a greater risk of developing MI within 30 days of disease. Males, comorbid patients, and older individuals were at a higher risk of MI.

Irish Pharmacy Union President, Dermot Twomey

(HERPES ZOSTER VACCINE RECOMBINANT, ADJUVANTED)

IF YOU CAN PREVENT SHINGLES SUFFERING, WHY WOULDN’T YOU?3

SHINGRIX demonstrated >90% efficacy against shingles in all age groups aged 50 years of age or older, based on pooled data from two large, phase 3 randomised control trials.1,2

Shingrix has a clinically acceptable safety profile. This is based on a pooled analysis of data generated in placebo-controlled clinical studies. Local reactions at the injection site may include pain, redness, swelling and itching and systemic reactions may include headache, gastrointestinal distress, muscle and joint pain, fatigue, shivering, fever and malaise.3

SHINGRIX IS NOW AVAILABLE

Shingrix powder and suspension for injection in vials [Herpes Zoster vaccine (recombinant, adjuvanted)].

(Please refer to SmPC before prescribing)

Composition: After reconstitution, one dose (0.5 mL) contains: Varicella Zoster Virus glycoprotein E antigen1,2 50 micrograms. (1adjuvanted with AS01B containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms, 3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms, 2glycoprotein E (gE) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology).

Therapeutic indications: Prevention of herpes zoster (HZ) and postherpetic neuralgia (PHN) in adults 50 years of age or older and in adults 18 years of age or older at increased risk of HZ. The use of this vaccine should be in accordance with official recommendations. Posology and method of

administration: For intramuscular injection only, preferably in the deltoid muscle. Primary Vaccination: Initial dose of 0.5 ml followed by a second 0.5 ml dose 2 months later. For flexibility the 2nd dose can be administered between 2 and 6 months after the first dose. For subjects who are or might become immunodeficient or immunosuppressed and whom would benefit from a shorter vaccination schedule, the 2nd dose can be given 1 to 2 months after the initial dose. Booster doses: need not established. Contraindications: Hypersensitivity to the active substances or any of the excipients. Special warnings and precautions for use: The name and the batch number of the administered product should be clearly recorded. Appropriate medical treatment and supervision should be readily available in case of an anaphylactic event. Administration of Shingrix should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, should not result in deferral. A protective immune response may not be elicited in all vaccinees. Never administer intravascularly or intradermally; subcutaneous administration not recommended as it may lead to an increase in transient local reactions. Caution in individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration. Syncope can occur following, or before any vaccination as a psychogenic response.

For more information on SHINGRIX, please scan the QR code. References : 1. Gauthier et al. Epidemiology and costs of herpes zoster and postherpetic

This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. There are no data to support replacing a dose of Shingrix with another HZ vaccine. There are limited data to support the use of Shingrix in individuals with a history of HZ and in frail individuals including those with multiple comorbidities. The benefits and risks of HZ vaccination should be weighed on an individual basis. Interactions: Shingrix can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23), 13-valent pneumococcal conjugate vaccine (PCV13) or reduced antigen diphtheria-tetanusacellular pertussis vaccine (dTpa). The vaccines should be administered at different injection sites. Fertility, pregnancy and lactation: There were no effects on male or female fertility in animal studies. It is preferable to avoid the use of Shingrix during pregnancy. The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied. It is unknown whether Shingrix is excreted in human milk. Effects on ability to drive and use machines: Shingrix may have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination. Undesirable effects: Very common (≥1/10): Headache, GIT symptoms, myalgia, injection site reactions, fatigue, chills, fever. Common (≥1/100 to <1/10): injection site pruritus, malaise. Uncommon (≥1/1000 to <1/100): lymphadenopathy, arthralgia. Rare (≥1/1000 to <1/100): Hypersensitivity reactions. Legal Category: POM A. Marketing Authorisation Number: EU/1/18/1272/001

Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A., Rue de l’institut 89, B-1330 Rixensart, Belgium. Further information is available from GlaxoSmithKline (Ireland) Ltd. 12 Riverwalk, Citywest Business Campus, Dublin 24. Telephone: 01-4955000. Code: PI-7757. Date of preparation: January 2023.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

of Product Characteristics (SPC), available on https://www.medicines.ie/medicines/shingrix-powder-and-suspe

Best Beauty Product

The beauty industry is fast-moving and highly saturated. Understanding changing consumer opinions and the behavioural indicators behind global trends is integral to securing the success of any company or brand within the space.

The Award was won by King Hair & Beauty Gold Dust Dry Shampoo.

Gold Dust Dry Shampoo is a weightless and intelligent formula that is kind to both hair and scalp. Quick and easy to apply ensuring oils are banished in record time, but with lasting effects. Small and discrete but BIG on results. A quick dusting revives the hair, adding body, and leaving your locks feeling clean and fresh to help maintain your crowning glory. The formula features a host of beneficial and unique ingredients, such as Corn Starch which is a fantastic, natural alternative to talc. Camellia Japomica Extract moisturises the hair and gives it a healthy shine, along with Orchird Extract which helps to repair damaged hair and promotes moisture retention, keeping your hair feeling moisturised.

Judges Comments

“This is a very unique product which has huge potential in the market category of doing very well. It is unlike anything on the market and the packaging and pack size is excellent and makes it very user friendly throughout the day.”

Dr Hauschka

Huile

Samantha King, CEO, King Hair & Beauty

King Hair & Beauty

Best Pregnancy/ Fertility Product

The OTC & Retail Pharmacy Product Award for Best Pregnancy/Fertility Product went to Pregnacare Plus.

Pregnacare Plus even greater nutritional care for mother and baby Pregnacare Plus dual pack provides the original fully comprehensive multivitamin tablet, which delivers the essential nutrients during pregnancy and breast-feeding, plus an additional Omega-3 capsule to provide a rich source of docosahexaenoic acid (DHA) which contributes to normal brain and eye development of the foetus.

Pregnacare Plus has been specially developed so that mothers-to-be can safeguard their extra dietary requirements, without confusion about which supplements to take.

Judges Comments

“The packaging is iconic and well known amongst customers. It is a great, unique product. Customer loyalty to the brand is exceptional. The information is well presented and easy to read on the packaging and is very well laid out.”

Andrea Fleming, Head of Healthcare, Valeo Healthcare

With you every step of the way

With you every step of the way

With you every step of the way

DURING PREGNANCY

Pregnacare® Original with19 nutrients including folic acid and vitamin D as recommended by the Department of Health.

AFTER Pregnacare® Breast-feeding with 21 nutrients including 10mcg vitamin D and 300mg DHA for mums during lactation.1

More than just folic acid

More than just folic acid

2

Most trusted by mums

2

Most recommended by midwives

2,3

Most recommended by midwives

2,3

Helping to make healthy mums and babies for over 25 years, Pregnacare® provides the recommended level of folic acid.4 It also provides a range of micronutrients, and is supported by unique clinical research with mums-to-be.6,7 BEFORE

Helping to make healthy mums and babies for over 25 years, Pregnacare® provides the recommended level of folic acid.4 It also provides a range of micronutrients, and is supported by unique clinical research with mums-to-be.6,7

Helping to make healthy mums and babies for over 25 years, Pregnacare® provides the recommended level of folic acid.4 It also provides a range of micronutrients, and is supported by unique clinical research with mums-to-be.6,7

Available from leading pharmacies, supermarkets and health food stores nationwide. For more information, visit www.pregnacare.com

Available from leading pharmacies, supermarkets and health food stores nationwide. For more information, visit www.pregnacare.com

Available from leading pharmacies, supermarkets and health food stores nationwide. For more information, visit www.pregnacare.com

3. Based on a survey of 1000 midwives.

1. Journal of the American College of Nutrition, Vol.18, No.5, 487-489 (1999).

2. For more information on this research, please visit www.pregnacare.com/mostrecommended. 3. Based on a survey of 1000 midwives.

4. Folic acid contributes to maternal tissue growth during pregnancy. Pregnacare® has always contained 400mcg folic acid, the level recommended for all women from the start of trying to conceive until the 12th week of pregnancy.

5. Source: NHS Choices. 6. Agrawal, R. et al. Prospective randomised trial of multiple micronutrients in women undergoing ovulation induction, Reproductive BioMedicine Online December 2011.

Folic acid contributes to maternal tissue growth during pregnancy. Pregnacare® has always contained 400mcg folic acid, the level

7. L Brough et al. Effect of multiple-micronutrient supplementation on maternal nutrient status, infant birth weight and gestational age at birth in a low-income, multi-ethnic population. British Journal of Nutrition (2010), 104, 437-445. *Awarded Number 1 pregnancy supplement by NPPA & Mums and Tots Awards.

pregnancy supplement by NPPA & Mums and Tots Awards.

induction, Reproductive BioMedicine Online December 2011. 7. L Brough et al. Effect of multiple-micronutrient supplementation on maternal nutrient status, infant birth weight and gestational age at birth in a low-income, multi-ethnic population. British Journal of Nutrition (2010), 104, 437-445. *Awarded Number 1 pregnancy supplement by NPPA & Mums and Tots Awards.

For more information on promotions and POS, contact your Valeo Healthcare Account Manager or Sales Rep

For more information on promotions and POS, contact your Valeo Healthcare Account Manager or Sales Rep

David Keane 087 279 2860 david.keane@valeofoods.ie

Fintan Byrne 087 647 0764 fintan.byrne@valeofoods.ie

David Keane 087 279 2860 david.keane@valeofoods.ie

For more information on promotions and POS, contact your Valeo Healthcare Account Manager or Sales Rep David Keane 087 279 2860 david.keane@valeofoods.ie Fintan Byrne 087 647 0764 fintan.byrne@valeofoods.ie

Julie Webster 086 462 1723 julie.webster@valeofoods.ie

Fintan Byrne 087 647 0764 fintan.byrne@valeofoods.ie

Julie Webster 086 462 1723 julie.webster@valeofoods.ie

Stephen Moloney 087 699 9344 stephen.moloney@valeofoods.ie Eamonn Connolly 087 238 5648 eamonn.connolly@valeofoods.ie

Stephen Moloney 087 699 9344 stephen.moloney@valeofoods.ie

Eamonn Connolly 087 238 5648 eamonn.connolly@valeofoods.ie

Best Irish Pharmacy Brand

Irish brand Active Iron won the category for Best Irish Pharmacy Brand.

Active Iron is an iron supplement with a groundbreaking new method of delivering iron. Active Iron is clinically proven to increase iron levels by 94% whilst helping to avoid the common side effects of iron. Women living with low iron levels is a global problem affecting 1 in 4 women, with monthly periods being the leading cause of iron loss worldwide. For this reason, Active Iron are focused on supporting women’s health and supplement needs across Ireland through their campaign ‘Better Days. Period’. Active Iron is now recognised as a leading iron supplement in Irish pharmacy as they continue to put Irish women’s health needs at the heart of their brand campaigns.

In an increasingly borderless world, many consumers are favouring Irish pharmacy brand products. Research has shown that a brand’s country of origin can be as important as other purchasing criteria such as price and quality with many Irish pharmacy shoppers wanting to support local businesses, finding local more trustworthy and more attuned to their needs and wants.

“Active iron is a really brilliant Irish product. As a Pharmacist, I am very proud to be able to recommend such an iron supplement that has undergone extensive research at Trinity College and the everyday request for this product is a testament to the work that Solvotrin Therapeutics have put into this. The efforts to continuously engage in research post-launch of the product has to be recognised and the platform for HCPs as well as a user-friendly website for their target audience shows that they are prepared to go above and beyond to meet the needs of their customers.”

Judges Comments

Pat O’Flynn, CEO, Solvotrin Therapeutics

BEST IRISH PHARMACY BRAND WINNER 2023

Best Cough, Cold and Flu Product

The judges determined Bronchostop Cough Syrup as the winner for the Best Cough, Cold and Flu Product.

Bronchostop Cough Syrup and Pastilles are used for the relief of ANY cough based on traditional use. If consumers don’t know what type of cough they have or if their cough changes from one to another, Bronchostop takes the hassle out of finding a solution. Bronchostop is traditionally used for the relief of any cough such as chesty coughs and dry, tickly, irritating coughs and phlegm. Buttercup Bronchostop Berry Flavour Cough Pastilles contain thyme herb extract.

Buttercup Bronchostop Cough Syrup and Buttercup Bronchostop Berry Flavour Cough Pastilles are traditional herbal medicinal products used for the relief of coughs, such as chesty, dry, tickly, irritating coughs and catarrh, exclusively based upon long-standing use as traditional herbal remedies.

This OTC category has doubled in growth YTD, albeit from a low base in 2021 due to lockdown. +6% versus 2020. Cough medicines have experienced the largest demand followed by cold remedies and decongestants.

“For a product relatively recently introduced to the market, this has gone from strength to strength. Marketing includes ‘use for ANY cough’ - has been a huge factor. Availability in pastille form is a handy alternative to a bottle for travelling.”

Judges Comments

Niamh Costello, Brand Manager, Perrigo

Calpol Vapour Plug

VIVIO® Junior Cough Syrup Olbas Oil

IRELANDS No.1 COUGH BRAND*

TO RELIEVE ANY COUGH

1,2

1 Associated with Common Cold, Bronchostop Junior is a MD. 2 Based on Traditional use, Bronchostop Adult is a THR. * Based on combined IQVIA Data - June 2022. Buttercup Bronchostop Cough Syrup contains thyme herb extract and marshmallow root extract. A traditional herbal medicinal product for the relief of coughs, such as chesty coughs and dry, tickly, irritating coughs and catarrh, exclusively based upon long-standing use as a traditional remedy. Adults and children over 12 years: 15ml every 4 hours, 4 times per day. Max 6 doses (90ml) per day. Max dose should not be exceeded. To be taken 30 to 60 minutes before or after intake of other medicines. Not recommended for children under 12 years. To be administered undiluted or diluted in water or warm tea. Seek medical advice if symptoms persist after 7 days or if dyspnoea, fever or purulent sputum occurs. Contraindications: Hypersensitivity to marshmallow root, thyme, to other members of the Lamiaceae family or to any of the excipients. Warnings and precautions: Asthmatics and atopic patients should consult a doctor before using the medicine. Contains E218 and E216 that may cause allergic reactions (possibly delayed). Patients with HFI, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take themedicine. The additive effect of concomitantly administered products containing fructose (or sorbitol) and dietary intake of fructose (or sorbitol) should be considered. Pregnancy and lactation: Not recommended. Side effects: pruritus, rash, urticaria, angioedema, anaphylactic reaction, oral mucosal blistering, abdominal pain, diarrhoea, nausea, vomiting, dyspnoea, exacerbation of asthma. Legal classification: GSL. TR 2006/001/001.TR Holder: Kwizda Pharma GmbH, Effingergasse 21, A-1160

Vienna, Austria. RRP (ex VAT): €4.99 Date of preparation: 05/2022. SPC: http://www.medicines.ie/medicine/16380/SPC/Buttercup+Bronchostop+Cough+Syrup/ Bronchostop Junior is a medical device according to Directive 93/42/EEC, used to relieve any cough (dry & chesty) associated with a cold for children from 1 year. Children under 3 years of age should consult with a doctor to exclude more serious diseases being present. Use in children under 1 year of age is not recommended. Children aged 1 year and above: 5ml up to 3 times daily. Children 2 to 3 years: 5ml up to 4 times daily. Children 4 to 5 years: 7.5ml up to 4 times daily. Children 6 to 11 years: 15 ml up to 4 times daily. Always read the Instructions for Use. Date of preparation: 05/2022.

Date of preparation: August 2022. IRE/BRO/2022/37

Best Eye Care Product

The Award for Best Eye Care

Product went to HYLO-FORTE®, an eye drop containing 0.2% sodium hyaluronate that is used for the intensive and therapeutic lubrication of the ocular surface in more severe and persistent dry eye sensation.

HYLO-FORTE® is contact lens compatible and it’s preservative and phosphate free formula means it can be used as often as required. Delivered via the patented COMOD® delivery system, HYLO-FORTE® releases one drop per pump and has a guaranteed 300 drops per bottle. HYLO-FORTE® can also be used for up to 6 months from first opening, making it economical and cost effective.

Consistently strong growth is expected within OTC Eye Care market in the future. Screen time is having a negative impact on consumers’ eyes, which often dry out and become sore. Innovation is likely to also fuel growth over the coming years.

Judges Comments

“A fantastic product which has quickly become one of our top-selling and most dispensed eye-drops. Great to see how invested the company are in sustainability and becoming more environmentally friendly. They provide great training and support to pharmacies.”

Patrick Hensey, National Sales Manager, Scope

Best Oral Care Product

TePe EasyPick - the perfect alternative to regular toothpicks, scooped the Award for Best Oral Care Product.

TePe EasyPick is a patented simple and easy to use pick to remove food deposits between your teeth. They are an easy and efficient way to clean the hard-to-reach areas between your teeth. A firm but flexible core, covered in a soft silicon coating, and a non-slip grip ensure effortless and efficient cleaning. The durable plastic is what makes them superior to wooden picks. TePe EasyPick are an on-the-go product. Overlapping conical sizes to fit all interdental spaces. The unique lamellae allows for a wide contact area with the approximal surfaces.

With lockdowns, many dentist facilities have had to shut, driving those consumers who were already taking proper care of their oral hygiene to further their efforts.

“Great little product and so handy for on-the-go and in-between cleaning. Tepe brand has such a loyal following and trustworthy brand. The stands work very well in-store for promotion. Good support from the supplier.”

Judges Comments

Caroline Finucane, Head of Marketing, Jennifer Berry, Marketing Executive, Karoline Kelly, Head of Sales - Ocean Healthcare

Polished London’s Hydro XP Dental Capsule

Sonisk Sonic Toothbrush

Jordan Green Clean Gentle Whitening Toothpaste

Best Pain Relief Product

Calpol is Ireland’s #1 Paediatric Pain Brand (based on IMS units, IMS/Nielsen Value), trusted by HCPs for over 45 years and now it is the winner of the OTC & Retail Pharmacy Product Awards Best Pain Relief Product for 2023.

Calpol is specially formulated for children and gets to work on fever in 15 minutes. It is suitable from 2 months plus, gentle on tummies (can be used with an upset stomach) and kids love the taste. Calpol Infant range is available in Original and Sugar Free Formulations in 60ml and 140ml size. Dosing syringe is included and is strawberry flavoured.

Calpol Six Plus Suspension range is available in Original (orange flavour) and Sugar Free (strawberry flavour) in 60ml and 140ml sizes and is suitable from age 6. Calpol Six Plus Fastmelts are a strawberry flavour tablet that melt in the mouth – no water needed.

“Calpol continues to outperform its competitors, it’s a household name for generations and it’s a parent’s go-to product for practically every childhood illness. Other brands have tried to compete in the liquid paracetamol market, but none have come even close to Calpol’s value to the pharmacy, its brand loyalty & advocacy. The extension of the range into nasal sprays, plugin vapour products etc has further cemented its place as the No 1 children’s product in Irish pharmacy.”

Judges Comments

Best Digestive Product

It was a tough call for the Best Digestive Product, but the judges felt overwhelmingly that the winner for 2023 is Alflorex® .

Alflorex® is the leading probiotic for IBS, a condition that affects up to 1 in 7 people in Ireland every day. This probiotic is taken daily to manage and prevent recurrence of IBS symptoms. It costs approx. ¤1/day and reduces ALL of the symptoms of IBS including: abdominal pain - bloating & gas - unpredictable bowel movements like alternating diarrhoea and constipation The unique 35624® culture in Alflorex is a naturally occurring bacterial strain found in the human gut.

This Bifidobacterium longum culture is part of the family of bacteria given by mother to baby at birth. The main long-term aim for Alflorex is to strive to have all IBS patients in Ireland take Alflorex for 1 month. The product conversion score is more than 80% (continued usage) and with a high percentage of this group needing direction and treatment we believe Alflorex can change their lives.

“I have had excellent experiences for my customers using alflorex in practice with many customers trialling and then continuing use and remaining loyal to the brand after achieving excellent results where even prescription treatments have been tried. There is excellent peer reviewed clinical evidence behind the product and this is vital when offering advice to customers. There has been a high level of investment behind the brand and in the education of health care providers and this is paying off as we would regularly see this prescribed by Consultants and teams in the hospital.”

Judges Comments

Shirley O’Regan, Marketing Manager, PrecisionBiotics

Best Natural Product

Described as a ‘true classic’ – Dr Hauschka Rose Day Cream won the Best Natural Product Award for 2023.

Celebrity favourite and the hero of the Dr Hauschka range, Rose Cream was the product on which Dr Hauschka and Elisabeth Sigmund funded their WALA natural skin care company in 1967.

Rose Day Cream captures the strength and softness of the rose to nourish and protect normal, dry and sensitive skin. Especially beneficial for skin prone to redness, irritation and couperose. The rich, luxurious formulation harmonises oil and moisture content, gently guiding the skin to a state of comfort, balance and radiance.

More and more consumers are in search of natural solutions to their ailments, including both homeopathic remedies and supplements supportive of a healthier lifestyle.

“Dr Hauschka Rose Day Cream is a premium quality product that provides effective and luxurious skincare for individuals who are conscious of their skin health and the environment. The day cream is made from natural and organic ingredients, and it is free from harmful chemicals, such as parabens, synthetic fragrances, and mineral oils. It is gentle on the skin and effectively moisturizes and protects the skin from environmental stressors. The day cream has a delicate rose scent that leaves the skin feeling refreshed and rejuvenated. Dr Hauschka Rose Day Cream is a unique and innovative product that offers a natural alternative to traditional skin care products. Overall, it is a recommended product that meets the needs of those who are looking for a natural, effective, and luxurious skin care solution. ”

Judges Comments

Best Immunity Product

Best Immunity Product for 2023 resulted in top marks for Udo’s Choice Super 8 Immune.

A high strength microbiotic with 42 Billion friendly live bacteria per capsule + Vitamin C. Super 8 Immune contains a powerful therapeutic formula of eight specific strains of friendly bacteria specially formulated for supporting flora imbalance or disruption and supporting immune function.

• High Strength: Minimum of 42 billion ‘friendly’ bacteria per capsule with Vitamin C

• Contains 8 strains of bacteria chosen for their value to both the upper and lower bowel health

• Gastric acid resistant strains

• Ideal post-antibiotic

• Refrigerated to preserve ‘live’ bacteria

• High levels of friendly bacteria in the gut will boost the immune system

A healthy immune system is the first step of attack against outside invaders such as bacteria or viruses. When an immune system is strong, consumers are more likely to be able to ward off sickness.

Judges Comments

“Gold standard probiotic product in pharmacy. Very high awareness among the general public and very high brand loyalty also. A very decent product I am happy to recommend.”

Sarah Brereton, Nutritional Therapist with Udo’s Choice Ireland

Best Women’s Product

Optibac Probiotics for Women

- recognised as one of the best probiotics for intimate health, won the category for Best Women’s Product.

It is Optibac’s best reviewed supplement, being highly recommended by complementary healthcare practitioners, top UK gynaecologists, and consumers alike. This specialist supplement is designed specifically for the support of vaginal and urinary tract. For Women contains highly researched strains of friendly probiotic bacteria, which are scientifically proven to reach the intimate area and complement the natural vaginal flora.

Optibac Probiotics For Women is the most researched probiotic supplement for vaginal health. It contains a world-renowned combination of probiotic strains, Lactobacillus rhamnosus GR-1® & Lactobacillus reuteri RC-14®, which have been clinically trialled in thousands of women around the world. Featured in over 30 clinical studies, they are the most researched probiotic strains for uro-genital health. The unique formula has been designed particularly for those who suffer with thrush, cystitis, or bacterial vaginosis (BV) infections.

Judges Comments

“A decent product, it’s definitely an area we are asked to help with regularly. It’s good to have a product that I can look to when asked for a recommendation and know that there is research behind it, and why it is the best one.”

Best Baby and Children’s Supplement

Baby and Children’s Supplement was Optibac Probiotics Babies & Children.

Optibac Probiotics Babies & Children is a highly researched, expert formula designed especially for use from birth to twelve years of age. It contains 3 of the most scientifically proven probiotic strains for babies and children: Lactobacillus rhamnosus HN001, L. rhamnosus GG – the most scientifically studied strain in the world - and Bifidobacterium breve M-16V® which has been used in over 140 baby care units across the globe.

Collectively, these world-renowned strains have been trialled in over 5,000 children worldwide. Along with added vitamin D and prebiotic FOS fibres, this specialist supplement offers all-round support for digestion, immunity, and skin health in children of all ages, in a natural, sugar-free format.

“Optibac Probiotics Babies & Children is a high-quality product that provides essential probiotics for infants and young children. It is a trusted and well-respected brand that has a strong reputation for safety and efficacy. The product is specifically formulated to support children’s digestive health and immunity, and it is available in different formats and strengths to suit different age groups. Optibac Probiotics Babies & Children has been clinically tested and proven to be effective, and it is backed by scientific research. The brand’s marketing campaigns and social media presence are effective in building awareness and promoting its benefits. Overall, Optibac Probiotics Babies & Children is a highly recommended product that meets the needs of parents who are looking for a reliable and safe probiotic supplement for their children. It is a top contender in the children’s probiotics category for OTC awards.”

Judges Comments

Best Skincare Product

Best Skincare Product for 2023 at the OTC & Retail Pharmacy Product Awards was Elave Daily Defence.

Since 1934, when Joseph Gardiner founded the first family apothecary in Ireland, the Gardiner family have been creating sensitive skincare solutions which combine our expertise in traditional formulations with the latest dermatological advances to provide expert, cruelty-free, sustainable, safe sensitive skincare

Many consumers in Ireland have educated themselves about skin care to discover and experiment. For example, research suggests that consumers are now more willing to try new beauty products compared to pre-pandemic years.

“Elave Daily Defense is a highquality product that provides effective and gentle skin care for individuals who are conscious of their skin health. The daily defense moisturizer is specially formulated for sensitive skin, and it is free from harmful chemicals, such as parabens, sulfates, and fragrances. It effectively hydrates and nourishes the skin, while also providing protection from UV rays and environmental stressors. The moisturizer is non-greasy, and it is quickly absorbed by the skin, leaving it feeling soft and smooth. Overall a highly recommended product that meets the needs of those who are looking for a gentle, effective, and affordable skin care solution. It is loved by those who have tried it for its effectiveness and gentle nature.

Judges Comments

Mark Darby, International Marketing Manager, Gardiner Family Apothecary

Best Baby and Children’s Product

Best Baby and Children’s Product was won by unanimous judges decision. The Award for 2023 went to Tonstix.

Tonstix Honey Jelly Pops for Childrens Sore Throats & Coughs are an all natural product formulated to melt in the mouth which facilitates lubrication of irritated throats caused by allergies, infections, and viruses. With added Vitamin C and Zinc, it gives instant comfort to unsettled children. Their unique stick person shape makes them the perfect size for little hands to hold. Tonstix comes with a set of fun stickers to cheer children up with a moment of fun and can help them communicate how they are feeling, which is often challenging particularly for frustrated toddlers when they are unwell.

Baby care and child-specific products have an important role to play in pharmacy particularly in Ireland as birth rates here are currently higher than the EU average. Last year, Ireland’s birth rate increased by just over 16% to 16,131 in the first quarter of the year when compared with the same period in 2021.

Great product, nothing else like this in the pharmacy market. Love the way this product is all-natural and can be used from 2+ years. Really nice taste off the product and safety feature of the arms is great. Irish product and designed by a mum who saw the gap in the market and the need for the product. Packaging is fun and gives lots of information about the product. Also they are diary free, gluten free, nut free so an extra selling point.”

Judges Comments

Left to right - Denise Lauaki & Sinead Crowthers, with sons, Founders, Soothing Solutions Ltd

Klearvol Capsules

Matchstick Monkey Eucerin Aquaphor Soothing Skin Balm

Best VMS Product

Best VMS Product was won by O.R.S Hydration Tablets.

Fast, Proven Hydration Clinova’s innovative O.R.S soluble hydration tablets are based on the standard oral rehydration salts formula. Containing a balanced combination of glucose, salts and electrolytes. The soluble tablets replenish water and salts, thereby helping to maintain a proper fluid balance. Perfect for before, during or after exercise. Drop, dissolve, drink! O.R.S is used by:

• People who lose excess fluid

• Professional and recreational athletes

• Visitors to hot/tropical countries

• People who are dehydrated due to alcohol consumption

• People who work in hot climates O.R.S Sport contains added Vitamin D and Magnesium

“This brand really came to the forefront over the last two years. With other brands o/s this has not become the no1 performer in this category. Good PR and marketing. Strong packaging. Good training from the supplier.”

Judges Comments

Norma Pentony - Pharmed Marketing Team, Cassandra Fanara - Pharmed Brand Asset Manager

Best Sleep/ Stress Relief product

Ireland’s number one sleep aid brand, Nytol won the Best Sleep/ Stress Product 2023.

Nytol is available in pharmacy only to help consumers get a good night’s sleep. Nytol One A Night 50mg Tablets are used to relieve temporary sleeping difficulties in adults. Nytol can help with all round sleep cycle support; helping consumers to drift off gently, improve quality of sleep and wake up feeling refreshed.

Nytol is the only clinically proven sleep aid available without prescription from your pharmacist. Nytol One-A-Night 50mg tablets contains diphenhydramine hydrochloride. An aid to the relief of temporary sleep disturbances in adults.

Judges Comments

“A very strong addition to the market, the first proper OTC product supporting sleep. strong support to date. Very well marketed with pharmacies and consumers and good supporting merchandising options for in-store. Strong packaging with clear claims. A really strong addition to the Sleep category in pharmacy.”

Fiona Clancy, Marketing Manager, Perrigo

Best Launch of the Year

It was a second win for Tonstix Honey Jelly Pops for Childrens Sore Throats & Coughs, as they also scooped the title of Best Launch of the Year.

Tonstix Honey Jelly Pops for Childrens Sore Throats & Coughs are an all natural product formulated to melt in the mouth which facilitates lubrication of irritated throats caused by allergies, infections, and viruses. With added Vitamin C and Zinc, it gives instant comfort to unsettled children.

Their unique stick person shape makes them the perfect size for little hands to hold. Tonstix comes with a set of fun stickers to cheer children up with a moment of fun and can help them communicate how they are feeling, which is often challenging particularly for frustrated toddlers when they are unwell.

“A brilliant product, which fills a massive gap on our pharmacy shelves. We have seen lots of repeat customers for this product. As a mother of a child with a sore throat while judging these awards I can confirm the Tonstix worked a treat for our three year old. The only issue is they taste too nice so her sibling wanted some too!”

Judges Comments

Left to right - Denise Lauaki & Sinead Crowthers, with sons, Founders, Soothing Solutions Ltd

Best Baby Skincare Product

Elave were also celebrating double success, taking home the title of Best Baby Skincare Product for 2023.

Elave Sensitive Baby Bath is certified ECOCERT Organic. ECOCERT is an international, independent certification body that sets strict requirements for products and their manufacturing chain to guarantee ingredients are derived from renewable resources and products are manufactured using environmentally friendly processes.

Containing Organic Aloe Barbadensis Leaf Juice, famous for its ability to soften and heal with naturally antimicrobial and anti-inflammatory properties while offering skin-penetrating hydration, it is known to reduce irritation, redness, and soothe the skin. Also containing naturally derived mild surfactants – cleansing agents that lower the surface tension of water so that it can penetrate more fully allowing two substances that normally do not mix to become dissolved or dispersed in one another, to separate dirt and oil from the skin.

are both accessible and reasonably priced. The product boasts natural ingredients suitable for the most sensitive skin and suitable for Vegans also, so caters to a wide consumer audience. The brand has sought approval from paediatricians and dermatologists which also contributes to the credibility and quality of the product, which will be well received by consumers. The packaging is elegant and provides appropriate information relating to the product and its ingredients which is important for parents choosing products for their babies.”

Judges Comments

“This product caters to the demand for sustainable products that

Mark Darby, International Marketing Manager, Gardiner Family Apothecary

Clonmel Healthcare’s Movymia® (Teriparatide) is recommended as a Best Value Medicine

Effective from 1st March 2023 Movymia® is recommended as a Best Value Medicine for Teriparatide on the High Tech Arrangement.1

Implementation of this recommendation will lead to significant savings for the health service.1

MOVYMIA 20 MICROGRAMS/80 MICROLITERS SOLUTION FOR INJECTION

Movymia® was launched on the Irish market in 2019, providing increased access for patients to advanced medicines. In February 2023 Clonmel Healthcare received confirmation from the HSE Medicines Management Programme that Movymia has been recommended as a Best Value Medicine for Teriparatide.

Movymia® is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. Please refer to the Summary of Product Characteristics for further information. Movymia® is administered via a reusable, multi-dosage injection device;

the “Movymia® Pen”. The pen is designed to be used for the entire duration of the treatment.

The recent launch of Movymia® increases access for patients, physicians and pharmacists to affordable medicines. Clonmel Healthcare continues to grow and strengthen its portfolio of Biosimilar medicines.

Martin Gallagher, Director of Marketing / Biosimilars Division said “Since launching this product in 2019 we remain steadfastly committed to bringing a comprehensive range of Biosimilar medicines to the market, thus offering therapeutic options to the prescribing physicians. We are delighted in doing so to contribute to the ongoing savings to the Irish Healthcare system, as well as supporting patient needs”.

1 Best Value Medicines https:// www.hse.ie/eng/about/who/cspd/ ncps/medicines-management/ best-value-medicines/teriparatide/ Accessed February 2023.

Each dose of 80 microliters contains 20 micrograms of teriparatide. One cartridge of 2.4 ml of solution contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml). Presentation: Glass cartridge. Indications: Movymia is indicated in adults. Treatment of osteoporosis in postmenopausal women and men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. Dosage: The recommended dose is 20 micrograms administered once daily. Patients should receive calcium and vitamin D supplements if dietary intake is inadequate. The maximum total duration of treatment is 24 months. The 24 month course should not be repeated over a patient’s lifetime. Following cessation of teriparatide therapy, patients may be continued on other osteoporosis therapies. Teriparatide must not be used in severe renal impairment. Use with caution in moderate renal impairment and impaired hepatic function. Teriparatide should not be used in paediatric patients (less than 18 years), or young adults with open epiphyses. Method of administration: Movymia should be administered once daily by subcutaneous injection in the thigh or abdomen. It should be administered exclusively with the Movymia Pen reusable, multidose medicine delivery system and the injection needles which are listed as compatible in the instructions provided with the pen. The pen and injection needles are not included with Movymia. However, for treatment initiation a cartridge and pen pack should be used. Movymia must not be used with any other pen. Patients must be trained to use the proper injection techniques. Contraindications: Hypersensitivity to the active substance or excipients. Pregnancy and Breastfeeding. Pre-existing hypercalcaemia, severe renal impairment, metabolic bone diseases other than primary osteoporosis or glucocorticoid-induced osteoporosis, unexplained elevations of alkaline phosphatase, prior external beam or implant radiation therapy to the skeleton, patients with skeletal malignancies or bone metastases. Warnings and precautions: In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Therefore, if blood samples for serum calcium measurements are taken, this should be done at least 16 hours after the most recent teriparatide injection. Routine calcium monitoring during therapy is not required. Teripa¬ratide may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials. Teriparatide should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition. In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, was relieved by placing subjects in a reclining position, and did not preclude continued treatment. Caution should be exercised in patients with moderate renal impairment. Experience in the younger adult population, including premenopausal women, is limited. Treatment should only be initiated if the benefit clearly outweighs risks in this population. Women of childbearing potential should use effective methods of contraception during use of teriparatide. If pregnancy occurs, teriparatide should be discontinued. The recommended treatment time of 24 months should not be exceeded. Contains sodium. Interactions: Digoxin, digitalis. Fertility, pregnancy and lactation: Women of child¬bearing potential should use effective methods of contraception during use of teriparatide. If pregnancy occurs, Movymia should be discontinued. Movymia is contraindicated for use during pregnancy and breast-feeding. The effect of teriparatide on human foetal development has not been studied. The potential risk for humans is unknown. Driving and operation of machinery: Teriparatide has no or negligible influence on the ability to drive and use machines. Transient, orthostatic hypotension or dizziness was observed in some patients. These patients should refrain from driving or the use of machines until symptoms have subsided. Undesirable effects: Nausea, pain in limb, headache, dizziness. Refer to Summary of Product Characteristics for other adverse effects. Adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Pack size: 1. A copy of the Summary of Product Characteristics is available upon request or go to www.clonmelhealthcare.ie. Marketing authorisation holder: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, German. Marketing authorisation number: EU/1/16/1161/001-003. Medicinal product subject to medical prescription. Date last revised: January 2022.

Martin Gallagher, Director of Marketing / Biosimilars Division, Clonmel Healthcare

soft capsules

Paralief 500 mg soft capsules, each capsule contains 500 mg of paracetamol. Pharmaceutical Form: Capsules, soft. Indications: For the short-term treatment of headache, toothache, muscle ache, lumbago, fever and pain with flu and colds. Dosage and administration: Adults and adolescents older than 15 years (> 55 kg body weight): 1 or 2 capsules (500-1,000 mg) at a time, with a maximum of 6 capsules (3,000 mg) within 24 hours. Adults and adolescents older than 15 years (≤ 55 kg body weight): The effective daily dose should not exceed 60 mg/kg/day (up to 2 g/day). Dose adjustment may be required in patients with renal or hepatic impairment. Refer to the SmPC for full dosage guidance. Method of administration: Oral. Swallow capsule with sufficient water. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and precautions: Long-term or frequent use is not advised. In young people who are treated with 60 mg/kg/day of paracetamol, combination with another antipyretic is not allowed except where there is a lack of efficacy. After the long-term use (> 3 months) of analgesics with intake every other day or more frequently, headache can occur or become worse. In these cases, the use of analgesics must be stopped in consultation with a doctor. The patient should be advised to avoid the simultaneous use of this medicinal product with others containing paracetamol, such as flu or cold medicinal products. If another medicine containing paracetamol is administered, the maximum paracetamol dose of 3,000 mg per day should not be exceeded, taking into account the content of all the medicines used by the patient. Patients diagnosed with impaired liver or kidney function, should seek medical advice before taking this medicinal product. The taking of several daily doses at once can cause severe damage to the liver. Immediate medical help must be sought even if the patient feels well because of the risk of irreversible damage to the liver. Caution is required when administering paracetamol to patients with moderate to severe renal insufficiency, mild to moderate hepatic insufficiency (incl. Gilbert’s syndrome), severe hepatic insufficiency (Child-Pugh > 9), acute hepatitis, the concomitant administration of medicinal products which have an influence on hepatic function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia, alcohol abuse, dehydration and chronic malnutrition. The risk of an overdose is greater in patients with non-cirrhotic alcoholic liver conditions. Caution is required in the case of chronic alcoholism. The daily dose may not exceed 2 grams in this case. No alcohol may be used during treatment with paracetamol. In the case of a high fever, symptoms of secondary infection or the persistence of symptoms, it will be necessary to reconsider the treatment. Caution is required in the case of asthmatic patients who are sensitive to acetylsalicylic acid as mild bronchospasms have been reported as a cross-reaction after the use of paracetamol. Cases of hepatic impairment or liver failure have been reported in patients with glutathione depletion, such as patients with severe malnutrition, anorexia or a low body mass index, or patients who chronically consume too much alcohol. In patients with a condition of glutathione depletion such as sepsis, the use of paracetamol may increase the risk of metabolic acidosis. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA). Close monitoring, including measurement of urinary 5-oxoproline, is recommended. Paracetamol can have an influence on the urine test with wolfram phosphoric acid as well as the blood sugar test with glucose oxidase peroxidase. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Interactions: Paracetamol is metabolised in the liver and can consequently enter into interactions with other medicinal products which follow the same metabolic route or which are able to inhibit or induce the route. In the case of chronic alcohol abuse and the use of drugs, which induce hepatic enzymes such as barbiturates and tricyclic antidepressants, an overdose of paracetamol can take a more severe course as a result of the increased and more rapid formation of toxic metabolites. Caution is required with the concomitant intake of enzymeinducing drugs. In the case of concomitant treatment with probenecid, the dose of paracetamol must be reduced. Paracetamol can cause an increase in the half-life of chloramphenicol. The rate of absorption of paracetamol can be increased by metoclopramide or domperidone and absorption can be reduced by colestyramine. The anticoagulatory effect of warfarin and other coumarins can increase during the long-term, regular use of paracetamol with an increase in the risk of bleeding as a result. With the concomitant chronic use of paracetamol and zidovudine, neutropenia often occurs. Salicylamide can prolong the half-life of paracetamol. Isoniazid ensures a reduction in the clearance of paracetamol, which possibly increases the activity and/or toxicity of paracetamol by preventing metabolism in the liver. The concomitant intake of paracetamol with lamotrigine ensures a reduction in the bioavailability of lamotrigine. Caution should be taken when paracetamol is used concomitantly with flucloxacillin. Fertility, pregnancy and lactation: If clinically needed, paracetamol can be used during pregnancy however, it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency. Paralief can be used in therapeutic doses by women who breast-feed. There are no available data on the effect of paracetamol on fertility. Undesirable effects: Agranulocytosis (after long-term use), thrombocytopenia, thrombocytopenic purpura, leukopenia, haemolytic anaemia, Allergies (exclusive of angioedema), Depression, confusion, hallucinations,Tremor, headache,Visual abnormalities, Oedema, Bleeding, abdominal pain, diarrhoea, nausea, vomiting,Abnormal hepatic function, hepatic failure, hepatic necrosis, jaundice, Hepatotoxicity, Sterile pyuria. Refer to the SmPC for a full list of undesirable effects. Adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Pack size 20 soft capsules. A copy of the Summary of Product Characteristics is available upon request or go to www.clonmelhealthcare.ie Marketing authorisation holder: Clonmel Healthcare Ltd. Waterford Road, Clonmel, Co. Tipperary Marketing authorisation number: PA126/020/7. Supply through pharmacies only. Date last revised: August 2022.

Topic Team Training – Sleep Disorders

Following on from the March issue Continuing Professional Development on the Management of Sleep Disorders, this 5-Minute Learning Module is designed to enhance the community pharmacy team understanding and ask further questions as to how you can support and advise patients.

is in the pursuit of obtaining over-the-counter medications.

Management of insomnia should include sleep hygiene education to correct the maladaptive behaviours they may have already developed. Pharmacological intervention in the form of non-prescription, over-thecounter sleep aids is widely used in the treatment of acute or shortterm insomnia. It is the decision of the pharmacist to use OTC sleep aids depending on their efficacy and safety based on the currently available data. The dosage and duration of administration should be closely monitored.

Obstructive sleep apnoea syndrome (OSA) is characterised by repetitive episodes of upper airway obstruction that occur during sleep, usually associated with a reduction in blood oxygen saturation or brief microarousals from sleep.

movement disorder, and bruxism. Sleep disruption or daytime fatigue/sleepiness is needed for the diagnosis of a sleep- related movement disorder.

Cognitive behavioural therapy for insomnia (CBTi) is a validated non-medication method to treat insomnia and is the first line treatment for chronic insomnia. Pharmacological treatment should be considered if CBTi is unsuccessful or not available or as an adjunct to CBTi.

After completing this module, you should recognise the varying types of sleep disorders that may present to the pharmacy and the OTC treatments available for each. Where pharmacy management is appropriate you will be able to explain to patients the nature of their type of disorder and suggest possible solutions. You will be able to give advice on current recommendations of symptom management and know how to signpost to relevant resources. Where a patient wishes to purchase OTC treatments, you should be able to support that person to make appropriate choices.

Sleep plays a vital role in the maintenance of optimal physical and mental health. Unfortunately, sleep disorders are highly prevalent and approximately 10% of the adult population suffers from insomnia. Several chronic physical and mental health conditions are linked to sleep deprivation and sleep disruption. Sleeping less

Consider:

compared to your individual sleep need results in sleep deprivation and if the continuity of sleep is disturbed, it results in poor sleep quality and both sleep deprivation and disruption has daytime consequences. There are multiple factors that can cause sleep disruption and presence of sleep disorders is one of them.

The International classification of sleep disorders – 3rd edition (ICSD – 3) details different categories of sleep disorders and their diagnostic criteria. The most common sleep disorders are insomnia and sleep breathing disorders followed by sleep related movement disorders.

The pharmacist is in a unique position to assist with the assessment and management of acute insomnia since pharmacists are the professionals who are contacted at the beginning of sleep difficulties, often to resolve the sleep difficulty while the individual

 Am I/my team aware of the licensed indications, maximum recommended duration of treatment, doses and age limitations for OTC products used for the various types of sleep disorders?

 Am I/my team aware of the medicines that can cause some sleep disorders, such as insomnia?

 Am I/my team confident in the difference between types of sleep disorders?

 Are we confident about raising issues of sleep disorders with customers?

OSA is characterised by loud snoring or brief gasps that alternate with episodes of silence or pauses that usually lasts at least 10 seconds. Patients are usually unaware of the loud snoring and breathing difficulty and it is often the bed partner who reports the difficulty. The patient may recount frequent arousals and brief awakenings that occur throughout the night.

The most reported sleep-related movement disorders are restless legs syndrome (RLS), periodic limb

Key Points:

 Ensure the pharmacy team knows to be sensitive in dealing with customers who may feel vulnerable as a result of insomnia

 Ensure pharmacy staff understand the function and importance of sleep and what effect a lack of sleep has on overall health

 Ensure we are all aware of how much sleep is enough for different groups of people

 Promote training and education as to the types of sleep disorders and their possible causes

 Educate the pharmacy team on how OTC treatments, including herbal remedies, differ

Pharmacists have an important role in the management of acute insomnia to prevent the progression to chronic insomnia by assessing, providing the sleep hygiene education, and managing the short-term sleep difficulties using over the counter sleep aids as deemed appropriate. Pharmacists can also aid by evaluating the symptoms and advising on the referral pathway to each individual patient.

Additional Resources: Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline.

International classification of sleep disorders – 3rd edition (ICSD – 3)

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.

IREL AND’S No.1

Sl eep A Id BRAND CAN H E LP YOU GET A GOOD NIGHT’S SLEEP

*Based on IQVIA sales data MAT 07/2022.

CLINICALLY PROVEN

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 dis-orders 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: Dry mouth, fatigue, 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, gastrointestinal disturbance, muscle twitching, urinary difficulty, urinary retention. Legal classification: P. PA1186/016/001. MAH: Chefaro Ireland DAC. The Sharp Building. Hogan Place. Dublin 2. Ireland. Date of preparation: 07/2022. RRP (ex. VAT): 20s €9.00. SPC: https://www.medicines.ie/medicines/nytol-one-a-night-50-mg-tablets-34889/smpc IRE NYT

ALZECURE ACHIEVES LAST PATIENT LAST VISIT (LPLV) IN ITS PHASE II CLINICAL TRIAL OF THE NON-OPIOID ACD440 IN NEUROPATHIC PAIN

AlzeCure Pharma AB (publ) (FN STO: ALZCUR) a pharmaceutical company that develops a broad portfolio of drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, has announced that the Last Patient Last Visit (LPLV) has now been completed in the ongoing phase II clinical trial with ACD440, the lead non-opioid drug candidate in the Painless platform, which is being developed against peripheral neuropathic pain.

”We look forward to seeing the results of this important phase II trial in peripheral neuropathic pain, an area of very high medical need where up to 80% of patients are not responding satisfactorily with their current treatments and where many are still prescribed opioids”, said Märta Segerdahl, project leader and CMO at AlzeCure Pharma. This double-blind, placebocontrolled, randomized cross-over study, which is carried out in collaboration with LINK Medical Research in Sweden, is aimed at evaluating the efficacy, safety and pharmacokinetics of AlzeCure’s lead drug candidate in pain, ACD440. The main results from the study are expected by the summer of 2023 at the latest.

AlzeCure’s drug candidate

ACD440 is a TRPV1 antagonist for the local treatment of patients with peripheral neuropathic pain. The discovery of TRPV1 that underlies the project was awarded the Nobel Prize in Physiology or Medicine in 2021. There is thus a strong scientific basis for this biological mechanism, including its relationship to pain signaling. ACD440, which is also the company’s leading drug candidate within the Painless platform, completed a positive phase Ib study in 2021. It showed both very good tolerability and safety, but also a potent, long-lasting painrelieving effect of the substance that is applied as a gel to the skin. The medical need in neuropathic pain is very great, not least to find alternatives to opioids. The neuropathic pain market is the single largest market segment in pain management with annual sales exceeding $11 billion. Up to 80% of patients do not get a satisfactory effect with their current treatments.

“The lack of effective and safe drugs, combined with the fact that upwards of 8% of the adult population suffers from

neuropathic pain, makes clear the great medical need and the enormous potential of our project. ACD440 can become a first-inclass drug and meet a very large patient need, which of cause is a value driver in connection with the outlicensing of the project”, said Martin Jönsson, CEO of AlzeCure Pharma.

KENNY FAMILY PRESENTS

CHEQUE FOR ¤40,500 TO UNIVERSITY HOSPITAL GALWAY

A very generous donation of ¤40,500 was recently presented to the Intensive Care Unit and the Patient Comfort Fund at University Hospital Galway (UHG) in memory of the late Mary Kenny from Loughrea, Co Galway. In addition, ¤5,000 was donated to Strange Boat Donor Foundation – The National Organ Donor Commemorative Garden (Circle of Life) located in Galway, and ¤2,000 to Quest Brain Injury Services, Galway.

The cheque was presented to the Intensive Care Unit and the Patient Comfort Fund, by John and Isabelle Kenny (husband and daughter of the late Mary

Kenny). The funds were raised through activities which included a GoFundMe page and a coffee morning bonanza at the Willow Café in conjunction with The Woodford Garden Centre. An evening of music was held in Carton House, as well as a raffle and spot prizes sponsored by local businesses. Finally, 20 brave individuals ‘Jumped for Mary’ by participating in a sky dive. John and Isabelle Kenny expressed their gratitude and said, “We would like to thank the doctors and nurses who cared for Mary in her final days. The medical and nursing team supported us to make the final decision to entrust Mary to the angels and to donate Mary’s organs, saving three people’s lives. To this dedicated, professional, supportive and compassionate team – from our family to yours we say a heartfelt thank you.”

Gillian Shanahan, Organ Donation Nurse Manager said, “We are forever humbled by organ donors and their families who find the strength in their depths of grief, to give the gift of life. On behalf of

Pictured at the cheque presentation to the Intensive Care Unit and Patient Comfort Fund at University Hospital Galway, from left front row: Bernie Moran; Edel Kelly, Assistant Directive of Nursing; John Kenny; Isabelle Kenny; Gillian Shanahan, Organ Donation Nurse Manager; Emma Gunning; Yvonne Shaw, Clinical Nurse Manager 2, ICU; Angela Burke O’Brien, Clinical Nurse Manager 2, ICU

From left back row: Pauline May, Assistant Director of Nursing /Former Organ Donation Nurse Manager; Pat Kenny; Dr John Bates, Consultant Intensivist; Ann Sheehan, Clinical Facilitator;

myself and the team at University Hospital Galway we would like to express our sincere gratitude to all those involved for their time and efforts in raising this substantial amount. The money will be used to improve the comfort and experience of patients and their families during their stay in the Intensive Care Unit.”

NEW DATA WHICH MAY SHOW INDICATOR OF OSTEOPOROSIS

Findings from a recent survey found that one in five (22%) adults have broken or fractured a bone since they turned 40 years of age. Over a third (35%) of these patients reported to have had a fragility fracture.1 Osteoporosis is a condition that causes bones to become weakened which can lead to fragility fractures. A fragility fracture is a broken bone that occurs due to minimal trauma, such as from a fall from standing height or less. Surprisingly, the rate of fragility fractures was high amongst 40-54 year olds with almost one in five (18%) surveyed having sustained a fragility fracture. This level of fractures would generally be expected amongst older age groups.

The research commissioned by Athena Pharmaceuticals surveyed 600 Irish men and women aged 40-90 to understand the occurrence of fragility fractures and awareness of appropriate nutritional supplementation for optimal bone health as people advance in age. The findings revealed a significant lack of awareness and confusion regarding the recommended daily

allowances (RDA) of both Calcium and Vitamin D. 85% of adults are unaware of the correct amount of Calcium they require daily and 90% are unclear on the correct amount of Vitamin D required for optimal bone health.1

Diet is a major contributor to optimal bone health. The recommended daily allowance of calcium and Vitamin D as defined by the Institute of Medicine and Food Safety Authority of Ireland4 is outlined in table 1. Calcium intake may be achieved by consuming three portions of any of the following: 1 glass (200ml) of milk, 1 carton (125g) yoghurt, 1 bottle (200ml) yoghurt drink, 2 thumbs (25g) of hard or semi hard cheese such as cheddar or edam or 2 thumbs (25g) soft cheese such as brie or camembert. Of those surveyed, over three-quarters (76%) of men and women above 40 years old are not getting the appropriate amounts of calcium in their diet, only consuming <50% of the RDA. Worryingly, 80% of adults who have a history of a fragility fracture are not consuming adequate calcium and alarmingly, 7% report they are consuming none. Vitamin D5 is available from two sources, sunlight exposure during the summer months and diet. Sources include natural foods such as egg yolks and oily fish, and fortified foods such as cheese and milk drinks. Supplements are usually necessary to get the recommended amount. But this survey found that 90% of people are unsure of the daily vitamin D requirements.

Dr Miriam Delaney, Specialist in Osteoporosis, Metabolic Bone Disorders and Calcium Metabolism at the Galway Clinic and Athena Pharmaceuticals Spokesperson, said: “It is important that people build and maintain their ‘bone bank’ throughout their lives. Anyone who has had a fragility fracture over the age of 40, is considered at high risk of osteoporosis and should discuss evaluation and treatment with their doctor. Achieving bone health may include behavioural changes, such as improving diet, engaging in weight-bearing exercise and taking oral supplements of calcium and vitamin D, if required.

“Eating behaviours have changed drastically over the past three decades with our families and children eating very differently to how we, or our parents, would have eaten in the past. We develop our bone bank during our early decades of life and after achieving peak bone mass, we naturally lose bone mass with ageing. Hence it is essential that our diet provides us with sufficient calcium and vitamin D, to minimise bone loss as we age. People with little or no calcium

in their diet are at elevated risk of osteoporosis and fractures in later years. Falling and fracturing the hip or spine, is a major cause of longterm pain, decreased mobility, loss of independence, hospitalisation and death in the elderly.

Individuals at a higher risk of Osteoporosis include those with many underlying illnesses, or taking certain medications such as oral steroids (for asthma or COPD), patients being treated for cancer, those with limited mobility, those in care homes or hospitals, etc and should be recognised as being at risk of weakened bones as a result of their underlying illness and treatment.6

When supplementation is deemed necessary, it is important that people get expert advice from their pharmacist or healthcare provider.”

For more information about the risk factors, assessment and treatment of osteoporosis visit https://www.osteoporosis. foundation/educational-hub/ material/patient-resources

2023 TRANSPLANT GAMES

Fourteen Irish transplant recipients will travel to Perth, Australia this month to represent Ireland at the World Transplant Games (15-21 April). This follows a four-year hiatus for the biennial World Transplant Games, as the previous event planned for 2021 had to be cancelled due to the global COVID-19 pandemic. The Irish squad gathered at the ALSAA Sports Complex, Dublin airport on Sunday, 12th March and were joined by family, friends and other members of the Transplant Team

Ireland programme, to receive their official team kit. The guest speaker at the event organised by the Irish Kidney Association was former Olympian triathlete Gavin Noble, the Olympic Federation of Ireland’s Chef de Mission for the Paris 2024 Olympic Games and 2023 European Games.

Ranging in age from 36 right up to 75, the current Transplant Team Ireland panel of 10 inspirational men and 4 women travelling to Perth have all received organ transplants including 2 liver, 2 bone marrow, and 10 kidney. They will be among over 1,200 participants from over 50 countries, all embracing their gift of life and honoring their donors in this celebration of life through sport.

In his talk to Transplant Team Ireland, Gavin Noble shared some of the wisdom he gained from the lead up to, and participation in, the 2012 Olympic Games in London and how he is now invested into helping other athletes be the best that they can be. He said, “Each and every one of you on the Transplant Team are an inspiration as you are living your best life, honouring your donors and representing your country in sport. Sport brings people together as does organ donation”.

The Irish Kidney Association is responsible for managing and supporting Transplant Team Ireland’s involvement at the Games and its National Advocacy and Projects Manager Colin White is the Team Manager.

To find out more about the World Transplant Games visit website www.worldtransplantgames.org and to find out more about members of Transplant Team Ireland and to follow their progress at the Games, you can follow the team blog; www.transplantteamireland.ie

SANOFI TO ACQUIRE PROVENTION BIO, ADDING TO PORTFOLIO TZIELD, THE FIRST DISEASE-MODIFYING TREATMENT FOR THE DELAY OF STAGE 3 TYPE 1 DIABETES (T1D) Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), have entered into an agreement under which Sanofi has agreed to acquire Provention Bio, Inc., for $25.00 per share in cash, representing an equity value of approximately $2.9 billion.

Transplant Team Ireland members pictured at a team gathering in preparation for The World Transplant Games held in Perth, Australia next month. Transplant Team Ireland's participation at the Games is managed by the Irish Kidney Association. Fourteen inspirational Irish men and women who have received liver, kidney and bone marrow transplants will travel to Perth, Australia next month to represent Ireland at the World Transplant Games (15-21 April). Picture Conor McCabe Photography

Clinical Profiles

The transaction adds an innovative, fully owned, first-inclass therapy in type 1 diabetes to Sanofi’s core asset portfolio in General Medicines and further drives its strategic shift toward products with a differentiated profile. TZIELD (teplizumab-mzwv) was approved in the U.S. last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

The acquisition is a strategic fit for Sanofi at the intersection of the company’s growth in immunemediated diseases and diseasemodifying therapies in areas of high unmet need, and its expertise in diabetes. Sanofi will continue to utilize its capabilities in diabetes to maximize TZIELD’s potential as a transformative therapy globally and in the U.S., aiming to delay the onset of Stage 3 type 1 diabetes for some of the approximately 65,000 people diagnosed every year1. The purchase builds on an existing co-promotion agreement with Provention Bio that is already delivering TZIELD to patients in need of this immunemediated therapy.

Olivier Charmeil, Executive Vice President, General Medicines, Sanofi said, “The acquisition of Provention Bio builds on Sanofi’s mission to deliver best- and firstin-class medicines and resonates with our purpose of chasing the miracles of science for the benefit of people. By coupling Provention Bio’s transformative innovation with Sanofi’s expertise, we aim to bring life-changing benefits to people at risk of developing Stage 3 type 1 diabetes. Any additional indications, approvals and pipeline assets only serve to further our excitement. Given our existing partnership and complementary work in the diabetes and immunology spaces, we foresee a seamless integration and execution.”

TZIELD is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D. Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening, and patients who progress to Stage 3 T1D eventually require insulin injections for life.

TZIELD is also in late-stage clinical development for the treatment of pediatric and adolescent patients that are newly diagnosed with clinical T1D (Stage 3). A Phase 3 trial, PROTECT, is currently underway and top line results are expected in the second half of 2023. Additional opportunities for TZIELD include re-dosing

and formulations as well as new therapeutic indications.

Provention Bio also brings certain pipeline assets in early development in immunemediated diseases.

Transaction Terms

Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Provention Bio, Inc. for $25.00 per share in cash, reflecting a total equity value of approximately $2.9 billion.

The consummation of the tender offer is subject to customary closing conditions, including the tender of a number of shares of Provention Bio, Inc. common stock, that together with shares already owned by Sanofi or its affiliates, represents at least a majority of the outstanding shares of Provention Bio, Inc. common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions.

If the tender offer is successfully completed, then following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Provention Bio, Inc., and all of the outstanding Provention Bio, Inc. shares that are not tendered in the tender offer will be converted into the right to receive the same $25.00 per share in cash offered to Provention Bio, Inc. shareholders in the tender offer. Sanofi plans to fund the transaction with available cash resources. Subject to the satisfaction or waiver of customary closing conditions, Sanofi currently expects to complete the acquisition in the second quarter of 2023.

PJT Partners is acting as exclusive financial advisor to Sanofi and Weil, Gotshal & Manges LLP is acting as its legal counsel. BofA Securities, Inc. and Centerview Partners LLC are acting as financial advisors to Provention Bio, Inc. and Ropes & Gray LLP is acting as its legal counsel.

DUPIXENT® (DUPILUMAB) APPROVED BY EUROPEAN COMMISSION AS FIRST AND ONLY TARGETED MEDICINE FOR CHILDREN AS YOUNG AS SIX MONTHS OLD WITH SEVERE ATOPIC DERMATITIS

The European Commission (EC) has approved Dupixent® (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy. With this approval, Dupixent is the

first and only targeted medicine indicated to treat these young children in Europe and the U.S.

Korey Capozza, MPH, Founder and Executive Director of Global Parents for Eczema Research (GPER) ays, “Watching an infant or young child grapple with the debilitating and wide-reaching impacts of severe atopic dermatitis is heartbreaking. I’ve personally witnessed how this chronic skin disease can disrupt the lives of entire families when left uncontrolled. Intervening with effective treatments during infancy and early childhood can help manage the challenging impact this disease has on children and their families during such formative years.”

Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, crusting and oozing, which can increase the risk of skin infection. Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers. Treatment options in this age group are primarily topical corticosteroids (TCS), which can be associated with safety risks and may impair growth when used long-term.

The approval is based on data from a Phase 3 trial evaluating Dupixent every four weeks (200 mg or 300 mg based on body weight) plus low-potency TCS or TCS alone (placebo) in 162 children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. At 16 weeks, Dupixent improved skin clearance and reduced overall disease severity and itch compared to placebo in the overall enrolled population. In a subset of those with severe atopic dermatitis, patients randomized to Dupixent (n=63) experienced the following compared to placebo (n=62) at 16 weeks:

• 46% of patients achieved 75% or greater improvement in overall disease severity compared to 7% treated with placebo, a coprimary endpoint.

• 14% of patients achieved clear or almost clear skin compared to 2% treated with placebo, a co-primary endpoint.

• 55% average reduction in overall disease severity from baseline compared to 10% with placebo.

• 42% average reduction in itch from baseline compared to a 1% increase with placebo.

Dupixent also improved sleep quality, skin pain and healthrelated quality of life compared to placebo in both the overall and severe populations. Long-term efficacy data showed the clinical benefit at 16 weeks was sustained through 52 weeks.

The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. The safety results of the 6 months to 5 years old trial were generally consistent with the known safety profile of Dupixent in its approved indications; in the trial, adverse events more commonly observed (≥5%) with Dupixent compared to placebo included eosinophilia and conjunctivitis. The long-term safety profile through 52 weeks was similar to the safety profile observed at 16 weeks, and consistent with what was observed in older patients with atopic dermatitis.

GAPS IN CARDIOVASCULAR CARE CONTRIBUTING TO DEATHS

A report launched by the National Institute for Prevention and Cardiovascular Health (www. nipc.ie) and the National CVD Prevention Council has identified gaping holes in Ireland’s cardiovascular healthcare. The report outlines that cardiovascular disease (CVD) kills nearly 9,000 in people in Ireland every year, despite an estimated 80% of premature CVD being preventable. While there is a myriad of gaps in how the Irish healthcare system detects signs of CVD, notable issues include Ireland having the lowest rate of detection of high blood pressure in Western Europe. This is particularly worrying when considering that in 75% of those that had a heart attack between 2017-2020, the heart attack was the first manifestation of CVD. Likewise, more than 1,200 people that suffered an ischaemic stroke in 2020 were found to also have atrial fibrillation (AF), a common type of irregular, usually rapid, heartbeat. However, AF was not identified in 40% of patients until they suffered the stroke.

The report recommends a screening program for familial hypercholesterolaemia (FH), a genetic condition which causes dangerously high cholesterol levels from birth. FH affects around 1 in 200-250 people in Ireland however the majority of this goes undetected. Childhood FH screening programmes are commonplace throughout Europe. The report also details issues in the treatment and discharge of

Minister Hildegarde Naughton, Minister of State at the Department of Health and at the Department of Children, Equality, Disability, Integration and Youth; Dr Angie Brown, Medical Director, Irish Heart Foundation; Consultant Cardiologist, Dublin; Professor J. William Mc Evoy, Research and Medical Director, National Institute for Prevention and Cardiovascular Health; Professor of Preventive Cardiology, University of Galway; Neil Johnson Acting Chief Executive, National Institute for Prevention and Cardiovascular Health and Chief Executive Croí.

patients following the detection of CVD. These issues include long waiting times in public hospitals and the lack of tailored discharge plans for patients.

Access to cardiac rehabilitation is paramount to the recovery of those

post-cardiac events yet it has significantly declined. A 2017 study previously identified that there was national capacity to meet only 39% of the need for cardiac rehabilitation while in 2021 there was a waiting list of more than

CALLING ALL COMMUNITY PHARMACISTS

Inclusion of an Optional Business Management Elective into the Pharmacy Degree Program

My name is Deirbhle Joyce and I am a Supervising Pharmacist. I am working in Community Pharmacy and undertaking a part-time MBA at University of Galway. As part of my Applied Strategic Leadership Project in Year 2, I have identified an unmet need in the Pharmacy Degree Program. I am conducting research on the inclusion of a Business/Management module as an optional elective into the Pharmacy curriculum. The target audience is Community pharmacists registered with the PSI. Completion of this survey is voluntary. It consists of 10 questions, with an option to add additional comments. It should take no longer than 4 minutes to complete.

2,800 people, with 40% waiting at least three months following hospital discharge.

The issues in the management of patient discharges are particularly worrying when considering that in the absence of Irish data, the report references a Swedish study which reveals that nearly 20% of people that suffer a heart attack die from a cardiovascular cause or experience a repeat heart attack or stroke within a year.

In response to the urgent needs identified by the report, NIPC and the National CVD Prevention Council is calling on the Government to develop a national

strategy to tackle cardiovascular disease (CVD). The previous national strategy expired in 2019 and has not been replaced.

The implementation of electronic health records is identified as a critically important key to integration of services required for effective prevention in clinical practice.

The report also outlines the requirement for investment in data collection and analysis to inform the strategy, the need to expand the role of nurses and allied health professionals and to increase access and care to disadvantaged groups.

Participants in this survey will be anonymous. Data will be used in aggregate form only and no individual persons will be identified in the reporting of the results. The data is collected for research purposes only. Full details of how your information is processed when it is collected with Microsoft Forms is documented in this privacy policy https://privacy.microsoft.com/en-US/privacystatement#mainnoticetoendusersmodule.

For further details, you can contact me at d.joyce11@nuigalway.ie.