IPN 2022 April

THE INDEPENDENT VOICE OF PHARMACY

In this issue:

NEWS: Remove Barriers for Smokers Page 7

REPORT: Finger on the Pharmacy Market Pulse Page 14

PERSPECTIVES: Pharmacists must stand with Ukraine Page 16

FEATURE: Managing Head Lice Page 24

CPD: Emergency Hormonal Contraception Page 41

AWARDS: OTC & Retail Pharmacy Product Award Winners Page 47

TEAM TRAINING: Sleep Disorders Page 82

FINANCE: Value in Volatility? Page 92

Joining Standards of Excellence & Innovation

The

Irish Pharmacy Awards 2022

“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 16 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.

2022 Award Categories:

 Avene Counter Assistant of the Year Award

 GSK Self-Care Award

 United Drug Business Development (Independent) Award

 Perrigo Superintendent Pharmacist of the Year

 PrecisionBiotics Community Pharmacist of the Year

 Uniphar Category Development of the Year Award

 JPA Brenson Lawlor Young Community Pharmacist of the Year Award

 Roche Diagnostics Points of Care Testing Pharmacy of the Year Award

 Evo Payments Bank of Ireland Innovation & Service Development (Chain) Award

 Originalis Community Pharmacy Team of the Year Award

 McLernons Innovation in Community Pharmacy Award

 Reckitt OTC Retailer of the Year Award

 Community Pharmacy Technician of the Year Award

 Pharmacy Student of the Year Award

 Online Pharmacy Retailer of the Year Award

 Easolief DUO Business Development (Chain) Award

BOOK YOUR TABLE

Over 600 of Ireland’s pharmacy industry professionals will join us on Saturday, May 21st 2022 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

Foreword

Page 8: Boots mark a first in Pharmacy

Page 10: Over 1.6 million illegal medicines detained

Page 12: EMCC Mentoring Award for Irish Institute of Pharmacy

Page 16: Calls across Europe for pharmacists to stand beside Ukraine

Page 18: Milestones celebrated at totalhealth

Page 20: Examining patient access to medicines

Page 29: Caring for women with epilepsy in your pharmacy

Page 47: OTC & Retail Pharmacy Product Award Winners for 2022

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

2022 & Retail 47

Orla Cooney

Christine McAuliffe

Kieran Moore

Dr Orla Neylon

DESIGN DIRECTOR

Ian Stoddart Design

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 Health Products Regulatory Authority (HPRA) has stated that the volume of detained illegal medicines in 2021 remained at a near record high, with its enforcement section detaining 1,604,589 million dosage units of falsified and other illegal products in 2021.

Announcing its annual detention figures, the HPRA once again stressed the health dangers associated with sourcing prescription medicines online. It is important that community pharmacies and pharmacy staff continue to advise their customers to only seek medicines from authorised sources. In the 12 months of 2021, the most significant categories of illegal products detained included sedatives (46%), anabolic steroids (13%), analgesics (10%) and erectile dysfunction medicines (6%).

Turn to page 10 to read more on this story.

There has been plenty of celebrations happening within the industry in this issue. The Irish Institute of Pharmacy are delighted their their mentoring programme has won the 2021 EMCC Mentoring Award.

“The IIOP are delighted to receive the award on behalf of the pharmacists who participated in our Mentoring Skills Training or as mentors or mentees on our Mentoring Programmes. Congratulations to each of you for developing your skills and supporting the development of Mentoring in the profession,” says Sarah Chambers, ePortfolio Review Project Lead on page 12.

LloydsPharmacy, for the third time in a four-year period been an outright winner within the Retail Excellence category at the 2021 InBUSINESS Recognition Awards whilst on page 47 we detail all the winners from the 2022 OTC & Retail Pharmacy product Awards.

The OTC & Retail Pharmacy Product Awards are the only industry awards that specifically recognises and rewards the companies and their products within the OTC market, acting as a celebration and showcase of product innovation, marketing and value to its customer.

These Awards are reviewed by an independent panel comprised of over 40 judges from across the community pharmacy sector, representing both multiple and independent pharmacies, buying groups, wholesalers and industry. Once again, the quantity and quality of the submissions surpassed previous years and across many categories it was a tough call.

The role of the community pharmacist is akin to the role of the community GP or the local vet. The family-owned pharmacy provides a much broader role than just dispensing. They are a key part of the network that binds a community together. However, “family-owned” needs to be re-defined in marketing terms to re-establish itself as a competitive advantage.

This is according to Family Business Advisor Paul Keogh who, on page 84, discusses his latest book which offers practical tips to help navigate your way through various business issues. Within this month’s features, Lead Clinical Pharmacist at Tallaght University Hospital Christine McAuliffe talks about the role of pharmacists in anticoagulation in Atrial Fibrillation.

I hope you enjoy the issue.

Regulars

FEATURE: CROHN’S DISEASE

CPD: EMERGENCY HORMONAL CONTRACEPTION

TEAM TRAINING: SLEEP DISORDERS

FEATURE: ANTICOAGULATION IN ATRIAL FIBRILLATION

FINANCE: VALUE IN VOLATILITY?

P37

P41

P82

P88

P92

CLINICAL PR: P98

Shortages Continue to Impact

Each year PGEU conducts a survey among its membership to map the impact of medicine shortages across Europe from the community pharmacists’ perspective. The 2021 PGEU Medicine Shortages Survey Results cover the responses from 27 European countries, including Ireland.

Key Findings:

• The continued high incidence of medicine shortages in most European countries, although most countries reported for the first time in years that the situation did not get worse compared with the previous year.

• The confirmation of occurring shortages of medical devices in pharmacies in most European countries.

• Slight improvement in terms of the average time spent by pharmacists to deal with shortages.

• The daily and burdensome impact medicine shortages have on patients and pharmacy practice across Europe.

• The existing gap in needed information, tools and legal solutions available to community pharmacists in many European countries for providing solutions to patients in case of a shortage.

PGEU President Roberto Tobia commented “The 2021 results show that medicine shortages continue to significantly disrupt patients’ timely access to certain medicines as well as community pharmacy practice. Despite the confirmation of the high incidence of shortages across European countries, it is hopeful to observe that for the first time in years most countries did not note a further worsening of the situation, which is a first step in the right direction. In combination with the expanded legal powers that have been

Recognition of UK Prescriptions

granted to community pharmacists to manage shortages in a number of countries, this has resulted in a slightly reduced average time spent by pharmacists to deal with shortages across Europe.

“With the ongoing revision of the EU general pharmaceutical legislation, policy makers now have an historic opportunity to create an adequate framework for improved prevention, monitoring and management of shortages across the EU. In this regard, PGEU already welcomes the recent adoption of the EU Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management as well as the findings of the European Commission study on medicine shortages.”

Now that the UK has left the EU, prescriptions issued by UK-based doctors following a telephone or video consultation are no longer valid in Ireland. There is specific legislation in place that provides for the continued recognition of hard copy (paper) prescriptions written by doctors, dentists and nurse prescribers based in the United Kingdom. However, now that the UK has left the EU, online prescriptions written by UK-based prescribers issued to people living in Ireland are no longer valid.

Therefore, if a teleconsultation is carried out by a UK based doctor for an Irish patient as part of a telemedicine service (even if accessed through an Irish website), neither a digital nor a physical prescription will be acceptable. On the other hand, paper-based prescriptions from the UK following a face-to-face consultation are valid (except for schedule 2, 3 and 4 part 1 controlled drugs). The current Brexit deal covers trade, not professional services, a teleconsultation is regarded as a professional service.

Pharma Support Ukraine

Medicines Shortages

The Health Products Regulatory Authority has been notified of a shortage of the following products:

• Calvepen 333mg TabletsPA0126/137/001

• Claforan Powder for Solution for Injection 500mgPA0540/037/002

• Claforan Powder for Solution for Injection 1gPA0540/037/003

• Dalacin 2% Vaginal CreamPA0822/119/002

• Fluorouracil 25mg/ml Solution for Injection or InfusionPA0822/223/001

• Gyno-Pevaryl Once 150mg Vaginal PessaryPA22650/006/001

• Januvia 25mg Film Coated Tablets - EU/1/07/383/002

• Lercanidipine Clonmel 20mg Tablets - PA0126/187/002

The following shortages have been resolved and supply has resumed to the Irish market:

• Axsain 0.075% w/w CreamPA1986/088/001

• Beromun 1mg Powder for Solution for InfusionEU/1/99/097/001

• Chlorpromazine Elixir BP 25mg/5ml Oral SolutionPA0281/124/001

• Clexane 8,000 IU (80mg)/0.8 mL Solution for Injection in Pre Filled SyringesPA0540/097/007

Head of Policy & Market Access for Europe

David Delaney recently attended an ‘incredibly moving and solutions focussed’ meeting, hosting Ukraine’s Ambassador to Ireland, Larysa Gerasko and Counsellor Olena Shaloput.

He commented, “As Medicines for Ireland and Medicines for Europe represent Europe’s largest maker and suppliers of Medicines – it was great hearing how our Pharma companies can best continue to get our medicines donations to people in extreme need in Ukraine, and how our thousands of Pharma

colleagues fundraising for Ukraine can support humanitarian aid into Ukraine asap.

“We also worked on practical ways to help our incoming new Ukrainian neighbours to Ireland, like helping many hopefully find jobs in the strong Pharma sector accross Ireland.

“Thank you Larysa and Olena. Your energy and determination is incredible. Our hearts are with your families back home. We will all try to make Ireland, and Europe, a great home for our new incoming friends from Ukraine,” he added.

• Dioralyte Blackcurrant Powder for Oral Solution (20 pack)PA0540/098/001

• Dioralyte Rebalance Citrus Powder for Oral Solution (6 pack) - PA0540/194/002

• Dioralyte Rebalance Natural Powder for Oral Solution (6 pack) - PA0540/194/003

• Invokana 100mg TabletsEU/1/13/884/002

• Invokana 300mg TabletsEU/1/13/884/006

• Januvia 50mg Film Coated Tablets - EU/1/07/383/008

• Sodium Iodide (I131) Capsule T - PA0690/006/002

• Zyvox 2mg/ml Solution for Infusion - PA0822/143/002

North-South Research

Taoiseach Micheál Martin TD and Minister for Further and Higher Education, Research, Innovation and Science Simon Harris TD have awarded ¤1.3m to seven collaborative research projects led by RCSI University of Medicine and Health Sciences and Queen’s University Belfast (QUB) under the North-South Research Programme.

The projects were among 62 successful applications for research collaborations between academics and institutions in Ireland and in Northern Ireland which have been awarded a total of ¤37.3 million under the first funding call for the programme.

The North-South Research Programme is a collaborative scheme funded through the Government’s Shared Island Fund. It is being administered by the Higher Education Authority (HEA) on behalf of the Department of Further and Higher Education, Research, Innovation and Science.

The RCSI and QUB-led projects were funded under Strand I: Bilateral researcher-researcher projects. The research spans fields including obesity, cancer, epilepsy, medical education, respiratory research and regenerative medicine including:

• DEFLATE: The Dramatic Effects of FKBPL on Adiposity via Gene Therapy, with RCSI lead Dr Stephanie Annett, School of Pharmacy and Biomolecular Sciences

• NeuVac: mRNA based vaccine for children with neuroblastoma, with RCSI lead Dr Olga Piskareva, Department of Anatomy and Regenerative Medicine

• PROMARIC: The role of proteases in microbiome diversity and antibiotic resistance in COPD; a new risk factor with a potential novel therapy, with RCSI lead Professor Gerry McElvaney, Department of Medicine

Professor Fergal O’Brien, Deputy Vice Chancellor for Research and Innovation at RCSI University of Medicine and Health Sciences, said: “Collaboration to share knowledge and expertise is central to our strategy for driving impactful research and innovation at RCSI. I welcome the funding from the North-South Research Programme which will further build on our research partnerships with Queen’s University and I look forward to the outcomes of these important projects to improve human health.”

Remove Unnecessary Barriers say Pharmacists

Pharmacists are calling for the removal of unnecessary barriers for people attempting to quit smoking, by ensuring that medical card holders are no longer required to attend a GP prior to being supplied with Nicotine Replacement Therapy (NRT) at their pharmacy.

NRT is an effective approach to reduce the physical symptoms associated with quitting smoking. However, while NRT is available in pharmacies nationwide since 2014, medical card holders that cannot afford to pay the cost of the NRT are still unable to access this vital treatment directly from their pharmacies.

In order for medical card holders to access this treatment under the medical card scheme, they are required to visit a GP to obtain a GMS prescription that will entitle them to source the treatment from their local pharmacy. This creates an unnecessary barrier for wouldbe quitters. There is no practical reason for this barrier to remain in place.

Community pharmacist and IPU President, Dermot Twomey says, “The rate of smoking has fallen steadily over the past five years in Ireland, and we must commend those who have given up smoking. However, 18% of the Irish population are smokers, with those aged 45 to 54 the most likely to smoke. This still paints a worrying picture, and it is clear we need to think differently about how we support people who want to quit smoking.”

Smoking rates are higher for those who are unemployed (38%) than those in employment (18%). They are also higher among those who have not completed the Leaving Certificate (22%) than those with a Leaving Certificate or higher (17%).

Mr Twomey continued, “NRT is proven to work and can significantly improve the chances that an attempt to quit will be successful. Unfortunately, medical card patients must go through their GP to access this treatment. At a time where GP shortages

across the country have made it increasingly difficult to get an appointment, this is creating an unnecessary barrier for would-be quitters. There is no reason why a medical card patient should require a prescription to access NRT and this arbitrary rule is preventing Ireland from lowering its smoking rates.”

LloydsPharmacy – In Business Excellence

The 2021 InBUSINESS Recognition Awards were

recently awarded at

a

gala

luncheon ceremony in the prestigious Clayton Hotel, Burlington Road, Dublin. The annual awards hosted by Chambers Ireland acknowledge outstanding accomplishments in the Irish business community. Winners are chosen, based on the broad criteria of business growth, profile of business, range of services and customer care.

LloydsPharmacy has for the third time in a four-year period been an outright winner in the Retail Excellence award category, with a continuous focus on providing patients and their families with the very best advice and support for all their health and wellbeing needs. Throughout the pandemic, LloydsPharmacy continued to offer the best in advice and patient care to customers across Ireland throughout 91 stores and online at loydspharmacy.ie.

This Award signifies LloydsPharmacy’s continued strategic focus on providing excellent customer service and continued investment in training, digitalisation and new service offerings instore and online.

LloydsPharmacy highly trained staff across Ireland are always on hand and open to discussing patient needs and answering any queries that customers may have. LloydsPharmacy staff undergo regular patient training

to ensure they are providing the upmost highest standard in care and advice.

While recent online investment from LloydsPharmacy and website upgrades has seen the online process of advice and ordering streamlined for customers with further digitalisation and patient offerings coming in 2022. With 91 stores nationwide, visit LloydsPharmacy store locator for details on your local pharmacy location and opening hours.

Boots Ireland is First Pharmacy in Ireland to Offer HPV Vaccinations

Boots Ireland have become the first pharmacy chain in Ireland to offer HPV vaccinations when the new service launched in 14 pharmacies nationwide. The vaccine is now available to customers who are not covered by the national immunisation programme and can be booked online via www.boots.ie/hpv.

• Dublin, Liffey Valley Shopping Centre

• Dublin, Omni Shopping Centre

• Donegal, Letterkenny Retail Park

• Galway, Shop Street

• Limerick, Childers Road

• Louth, Dundalk

• Kildare, Maynooth

• Wicklow, Bray

Cervical Screening Decline

New research conducted by Besins Healthcare has revealed that one quarter of women (25%) aged 45 – 65 who are experiencing perimenopause or the menopause are not regularly attending cervical screening appointments.

Human papillomavirus (HPV) is a group of more than 100 viruses that causes 1 in 20 cancers worldwide. Most people will contract HPV at some stage in their lives, with it being most common amongst people in their late teens and early 20s. Each year in Ireland HPV causes more than 400 cases of cancer in both men and women.

Boots Ireland pharmacies offering HPV vaccinations include:

• Cork, Half Moon Street

• Dublin, Blanchardstown Shopping Centre

• Dublin, Donnybrook

• Dublin, Grafton Street

• Dublin, Jervis Shopping Centre

• Westmeath, Athlone Golden Island Shopping Centre Stephen Watkins, Managing Director of Boots Ireland, commented, “We are incredibly proud to be announcing the rollout of the HPV vaccination service in 14 of our pharmacies nationwide from 23rd February. At Boots Ireland, we are always looking for new ways to support our customers by offering them access to innovative services and products and being the first pharmacy in the country to offer the HPV vaccine is an example of this effort. Vaccination against HPV plays an important role in the prevention of different forms of cancer amongst the male and female population and we are delighted to be able to play our part in reducing the burden that cancer can have on the individual and society.”

New appointment at McGreals Health

McGreals Health has announced the appointment of Derek Palmer to the position of Account Manager for the Novaerus by McGreals Health brand. The McGreals Group is headquartered in Blessington, Wicklow, and operates 11 pharmacy outlets as well as a primary care centre in the Leinster area.

In his new position, Derek will be focused on growing sales of the Novaerus range of air disinfection devices to support a rapidly growing national client base. He will manage strategic sales development across sectors including corporate, education, hospitality and retail, as well as supporting the wider McGreals and Novaerus teams.

Prior to his role at McGreals Health, Derek held the position of Key Account Executive and

Business Development Manager across the Diageo portfolio of brands for 28 years, working with major accounts in the licensed trade. His expertise expands to national sales, trade marketing, product launches, brand and event management and sponsorship.

Derek Palmer, Account Manager for the Novaerus by McGreals Health brand

13% of women noted that participation in cervical screening actually reduced when going through the menopause. When asked why their participation decreased, 35% of women reported that they found their cervical screening to be more painful or uncomfortable as a result of changes in their vaginal health. 17% of menopausal women believe that they are no longer eligible to attend screenings and 12% believe that as they could no longer get pregnant, screening was not required –both of which are incorrect.

These findings demonstrate that there are some misconceptions regarding the need for cervical screening when reaching the menopause and beyond.

Dr Caoimhe Hartley, GP and owner of Menopause Health said, “The menopause brings about many changes for women and thankfully more awareness and understanding of these symptoms has come about in recent years. However, what this research serves to highlight is that the menopause is leading to a decline in regular cervical screening which could lead to increased mortality if they were to develop cervical cancer at this stage of life. With approximately half of women going through perimenopause or the menopause experiencing vaginal atrophy, and 35% of women claiming that the screening is more painful or uncomfortable as a result, it is understandable why they may decline to participate in a cervical screen, but there are a range of ways to make the experience more comfortable.”

In Ireland, about 300 women will be diagnosed with cervical cancer every year and 90 women will die from it. Yet, 90% of cases can be identified and treated in a simple outpatient procedure if caught early.

New Ambassador for AYA

AYA, the leading Irish vitamin and supplement brand for all the family, has unveiled Anna Daly as its new Brand Ambassador for 2022.

With her busy lifestyle as a mum, broadcaster and entrepreneur Anna epitomises the AYA customer – someone who wants themselves and their family to feel their best every day.”

As an experienced broadcaster, businesswoman, and mum of three, Anna enjoys a busy lifestyle and relies on her AYA vitamins and supplements to help her to stay well, support her immunity, and give her the energy she needs to live life to the full. And she ensures her family take AYA supplements

regularly too, meeting their nutritional requirements every day. Anna’s Brand Ambassador work with AYA will see her supporting some exciting new product launches, creating social media content to promote the brand, and attending events throughout the year.

Anna Daly, AYA Brand Ambassador, comments, “Working with Irish brand, AYA, is a partnership that feels natural. I’m excited to become the face of a brand that Irish people rely on for trusted health supplements and key vitamins to boost our immune systems, in a time where we need that health boost more than ever.”

Aine Devlin, AYA’s Marketing Manager, states, “We’re thrilled to be working with Anna Daly this year as the AYA brand continues to grow from strength to strength.

To celebrate the announcement AYA has teamed up with Anna to give her social media followers the chance to win a year’s supply of AYA supplements worth ¤750 and a Fota Island Resort voucher worth ¤250 for one lucky winner and a friend each. To enter, head over to Anna’s Instagram and follow the instructions on her AYA post. Specially developed by Irish company Uniphar and exclusive to Irish Pharmacy, the AYA range of 34 products for adults, children and babies is widely available in pharmacies nationwide including @allcarepharmacyirl, @lifepharmacyirl, @hickeyspharma, @mccauleypharmacy, @cara_pharmacy, @mulliganspharmacy and @chtralee, where staff are trained to provide advice on appropriate products.

Over 1.6m Units of Illegal Medicines Detained

The Health Products Regulatory Authority (HPRA) has stated that the volume of detained illegal medicines in 2021 remained at a near record high, with its enforcement section detaining 1,604,589 million dosage units of falsified and other illegal products in 2021.

Announcing its annual detention figures, the HPRA once again stressed the health dangers associated with sourcing prescription medicines online and advised the general public to only seek medicines from authorised sources. In the 12 months of 2021, the most significant categories of illegal products detained included sedatives (46%), anabolic steroids (13%), analgesics (10%) and erectile dysfunction medicines (6%). The breakdown is:

• Sedative medicines – 741,492 units detained (583,805 units detained in 2020)

• Anabolic steroids – 204,843 units detained (101,683 units detained in 2020)

• Analgesic medicines – 161,670 units detained (145,921 units detained in 2020)

• Erectile dysfunction – 103,816 units were detained (484,846 in 2020 which included one detention of over 370,000 tablets)

• 56,385 units of Covid-19 medicines were detained, including 28,302 units of Ivermectin

• 461 websites, e-commerce listings and/or social media pages amended or shutdown

• 5 prosecution cases initiated, and seven voluntary formal cautions issued

According to Grainne Power, Director of Compliance with the HPRA, the high number of illicit medicines detected in 2021 is very concerning and when combined with the 2020 figures means that over 3.2 million units were detained over a two-year period.

“Every single one of the tablets, capsules and vials intercepted during 2021 was important. Our detentions disrupt the illicit market and we continue with our ongoing work in this area to disrupt the flow of counterfeit and falsified medicines into Ireland. We know that those who seek to profit from illegal medicines have little regard for the health of the end users they are supplying. Our goal, with a focus on impacting both supply and demand, is to protect the public from the risks associated with products for which there are no guarantees as to what they contain or under what conditions they have been manufactured.”

The HPRA works in close cooperation with colleagues from An Garda Síochána and Revenue’s Customs Service with whom there is significant inter-agency

collaboration to combat the illegal supply of health products into and within Ireland. It also co-operates and shares intelligence with other regulatory and law enforcement agencies worldwide to prevent the illegal manufacture, importation and distribution of medicines, medical devices, and cosmetics.

The HPRA is responsible for prosecuting cases where it considers that there is a significant risk to public health or where there are persistent noncompliances. Five prosecution cases were initiated in 2021. Three prosecutions related to the unauthorised supply of anabolic steroids, one related to the unauthorised supply of sildenafil citrate and one related to the unauthorised supply of medicinal products from a market stall.

FAST RELIEF OF ALLERGIES 24hr

Cetrine Allergy 10mg Film-Coated Tablets available in packs of 7s and 30s. Always read the leaflet.

ABBREVIATED PRESCRIBING INFORMATION

Product Name: Cetrine Allergy 10mg lm-coated tablets & 1 mg/ml oral solution. Composition(s): Each tablet contains 10 mg cetirizine dihydrochloride. One ml of the oral solution contains 1 mg cetirizine dihydrochloride. Description(s): White, oblong lm-coated tablets, scored on one side. Can be divided into equal halves. Clear, colourless liquid with banana avour.

Indication(s): Tablets: Adults and paediatric patients 6 years and above. Oral solution: Adults and children 2 years and above. Relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis (hay fever); relief of symptoms of chronic idiopathic urticaria.

Dosage: Tablets: Adults, elderly and children aged 12 years and over: 10 mg once daily. Children from 6 years to 12 years: 5 mg (half a tablet) twice daily. Moderate renal insu ciency (creatinine clearance CrCl 30-49 ml/min): 5 mg once daily. Severe renal insu ciency (creatinine clearance ≤30 ml/min): 5 mg once every 2 days. Children under 6 years: Not recommended. Oral solution: Children aged from 2 to 6 years: 2.5 mg twice daily (2.5 ml oral solution twice daily (half a measuring spoon twice daily)). Children aged from 6 to 12 years: 5 mg twice daily (5 ml oral solution (a full measuring spoon twice daily)). Adults and adolescents over 12 years of age: 10 mg once daily (10 ml oral solution (2 full measuring spoons)). Not recommended in children aged less than 2 years. Moderate renal insu ciency (creatinine clearance CrCl 30-49 ml/min): 5 mg once daily. Severe renal insu ciency (creatinine clearance ≤30 ml/min): 5 mg once every 2 days. In paediatric patients su ering from renal impairment: Adjust dose on an individual basis taking into account the renal clearance of the patient, his age and his body weight. Contraindications: History of hypersensitivity to the active substance, to any of the excipients, piperazine derivatives or hydroxyzine. Severe renal impairment < 10 ml/min creatinine clearance.

Warnings and Precautions for Use: Cetirizine may increase risk of urinary retention, therefore caution in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia). Caution in epileptic patients and patients at risk of convulsions. Discontinue use of cetirizine three days before allergy testing. Pruritis and/or urticaria may occur when cetirizine is stopped, even if the symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted. Tablets contain lactose. Oral solution contains sorbitol, propylene glycol, sodium (essentially ‘sodium free’), methyl - & propyl-parahydroxybenzoate.

Interactions: Caution is advised when taken concomitantly with alcohol or other CNS depressants. Cetirizine does not potentiate the e ect of alcohol (0.5 g/l blood levels). The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.

Pregnancy and Lactation: Caution during pregnancy and breast-feeding.

Ability to Drive and Use Machinery: Usually non-sedative, patients should take their response to the product into account. In sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.

Undesirable E ects: Cetirizine at the recommended dosage has minor adverse e ects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported. Although cetirizine is a selective antagonist of peripheral H1-receptors and is relatively free of anticholinergic activity, isolated cases of micturition di culty, eye accommodation disorders and dry mouth have been reported. Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported which resolves on discontinuation of the drug. Uncommon: Agitation, diarrhoea, pruritus, rash, asthenia, malaise, paraesthesia. See SPC for all adverse reactions.

Marketing Authorisation Holder: Rowex Ltd, Bantry, Co. Cork.

Marketing Authorisation Number: PA0711/075/002-003. 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: March 2021

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

IIOP Mentoring Programme - 2021 EMCC Mentoring Award

Written by Sarah Chambers, ePortfolio Review Project Lead, Irish Institute of Pharmacy: The Irish Institute of Pharmacy (IIOP) are delighted to announce that the mentoring programme has won the 2021 EMCC Mentoring Award!

National Service Plan

The Minister for Health Stephen Donnelly has approved the 2022 National Service Plan for the HSE which aims to reduce waiting lists, build hospital and other service capacity and continue to support the progress of important Sláintecare reforms.

The National Service Plan outlines the health and social care services that will be provided to the people of Ireland in 2022 within the allocated budget of ¤20.7bn.

Dr Riza Kadilar, EMCC Global President, said of the award winners says, “EMCC exists to develop, promote, and set the expectation of best practice in mentoring (as well as coaching and supervision) globally for the benefit of society. I am proud to see that the Irish Institute of Pharmacy as the winners of the 2021 EMCC mentoring award. Their exemplary work, especially during the pandemic, has been a source of inspiration for our community.”

The IIOP are delighted to receive the award on behalf of the pharmacists who participated in our Mentoring Skills Training or as mentors or mentees on our Mentoring Programmes.

Congratulations to each of you for developing your skills and supporting the development of Mentoring in the profession!

Congratulations to our mentoring ambassadors Louisa Power, Rachel Dungan, David Walsh, Michelle Kirrane Scott, Nadira Callachand, Ríona Tumelty, Fiona Leonard, Cian O’Caheny, Moyosola Tijani and Emer Lane who lead our mentoring community and advocate for mentoring across the profession.

Congratulations to our Steering Group members Catriona Campbell, Emily Kelly, John Bourke and AnneMarie de Frein who steer the programme at a strategic level ensuring the programme is sustainable and enjoyable and to programme lead

How can pharmacists who are interested in mentoring get involved?

1. Sign up for some Mentoring Skills Training

Since 2019, over 100 Pharmacists have completed Mentoring Skills Training to date with additional training sessions now on offer. The response to the training, run in conjunction with Kingstown College, has been hugely positive with pharmacists appreciating the practicality of the content and how applicable it is to their day-to-day work. The aim of the training programme is to introduce pharmacists to recognise the principles of mentorship and to assist you to engage with examples and scenarios that will help you to implement these principles into your own practice. It would be anticipated that those participating in this programme would be open to initiating mentoring relationships within the profession as part of the IIOP Mentoring Programme. Additional dates have been announced for April and May 2022 and you can book your place on the IIOP website now.

2. Join the CONNECT Mentoring Community

Our new CONNECT Mentoring community will give pharmacists who are interested in mentoring

a place to come together as a community to connect, learn and share. As a member of the mentoring community you will receive regular updates on the programme and be invited to CONNECT events where you can;

• CONNECT with like-minded pharmacists across the profession on a quarterly basis at events, exclusive to you.

• LEARN about putting mentoring skills into practice and how the mentoring programme is developing. Think peer-led, bite size, practical learning as well as regular updates on the programme.

• SHARE your ideas and your feedback so that together, we continue to build on the great work already happening.

The IIOP are committed to supporting this CONNECT community to shape the future of mentoring for pharmacy. So far, we have invited pharmacists to join this CONNECT community if they have either completed the IIOP Mentorship Skills Training and/or participated in our recent Mentoring Programme. If you would like to get involved get in touch with the IIOP Mentoring Programme Team at mentoring@iiop.ie.

3. Join the next Mentoring Programme

The next mentoring programme will launch in May 2022. Applications will be open to pharmacists from all sectors and all career stages.

It is time to cultivate a culture of mentorship within the Irish pharmacy profession. You can find out more on the Mentoring Homepage on the IIOP website.

The Minister for Health Stephen Donnelly said, “This is the largest financial allocation ever received by the health and social care services and it comes at a time when we are continuing to deliver reforms and improvements based on the recommendations of the Sláintecare report towards the delivery of Universal Healthcare.”

The NSP envisages that bed numbers within acute settings will significantly increase, including 1,146 additional acute beds by the end of 2022 (849 of which will be open by end-2021) and 19 additional critical care beds, to bring the total number of adult critical care beds to 340 by the end of 2022.

The funding for the Enhanced Community Care Programme will see completion of the rollout of 96 Community Healthcare Networks (CHNs) and 30 community specialist teams for older persons, as well as the establishment of 30 community specialist teams for people living with chronic disease, reducing our dependence on a hospital-centric model of care.

Crisis resolution services in mental health will continue to develop, with the addition of three teams and cafes in place by year-end, providing 900 additional interventions as alternatives to acute inpatient care and ED presentations.

The CAMHS telehealth hubs initiative will also progress, developing two further hubs in 2022 with an anticipated 200 new service users seen. 120,000 additional hours of personal assistant supports, and 30,000 additional hours of home support will be delivered in disability services.

pharmacy market in 2021.

PSI data suggests there have been 14 net openings since the beginning of 2021, bringing the number of community pharmacies in Ireland to 1,907.

Trends in Community Pharmacy

Every quarter, Fitzgerald Power prepare an analysis of the key trends in the Irish Community Pharmacy sector.

Market in Summary

Uniphar and Navi Uniphar has announced the acquisition of pharmacy services group Navi. Part of three acquisitions with combined revenue of ¤39 million, Navi’s high-tech distribution facilities and digital platforms will help bolster Uniphar’s community pharmacy sector offering.

Market Activity

Fitzgerald Power estimates 39 unit level changes of ownership during 2021. Despite the economic uncertainty over the past 2 years the Irish pharmacy M&A market has continued to perform strongly. Fitzgerald Power advised on 76% of the transactions in the Irish pharmacy market in 2021, in individual unit terms.

McKesson

McKesson has sold its UK Lloydspharmacy businesses to the private equity firm Aurelius Group for £477 million. The deal covers the company’s 1,325 pharmacies across the UK, wholesaler AAH, app LloydsDirect, Lloydspharmacy Online Doctor,

travel health service MASTA and its John Bell & Croyden branch in London.

Fitzgerald Power Wages Report

Fitzgerald Power released The Irish Community Pharmacy Wages Report 2020/21 in January 2022. The report showed increasing wages across the sector, as supply constraints and general inflationary factors put upward pressure on wages.

COVID-19

From the 22nd January the Irish government began to remove all COVID-19 related restrictions. Ireland’s high vaccination rate, and a potentially less virulent new variant, led to the easing of restrictions.

OTC Tracker

IQVIA data shows the largest growth in OTC classes was again in the VMS & tonics category this quarter. Minor OTC categories have seen significant growth, with medical and surgical aid seeing 61% growth over the period.

There has been a steep decline in closures over the period from 16 in 2020 to 6 in 2021. This may be partly explained by the pandemic, with State subsidies helping to sustain some businesses, while in other cases pharmacists may have been unwilling to close unviable pharmacies at a time of acute patient demand.

New Openings and Closures

SOURCE: PSI

Sales Pulse

It was another strong quarter for sales, with Fitzgerald Power estimating that eleven transactions completed in the 4th Quarter of 2021. In total we estimate that 39 transactions occurred in the Irish pharmacy market in 2021. PSI data suggests there have been 14 net openings since the beginning of 2021, bringing the number of community pharmacies in Ireland to 1,907. There has been a steep decline in closures over the period from 16 in 2020 to 6 in 2021. This may be

Completed Deals in

partly explained by the pandemic, with State subsidies helping to sustain some businesses, while in other cases pharmacists may have been unwilling to close unviable pharmacies at a time of acute patient demand.

by HSE Fees List Position

Wages Pulse

The Fitzgerald Power Irish Community Pharmacy Wages Report 2020/21 found widespread sectoral wage inflation in 2021. In the locum market, hourly rates remained high across all provinces.

Pharmacists Must Stand with Ukraine

Pharmacy

The International Pharmaceutical Federation (FIP), made the request on behalf of its member organisation the All-Ukrainian Pharmaceutical Chamber.

“FIP will always endeavour to support our colleagues across the world, responding to their requests and not acting alone. We will always assess need against request, but our offer of support is universal and equitable. We are witnessing heroic efforts by the Ukrainian people and our pharmacy colleagues. It is truly moving, inspiring and terrifying in equal measure,” said FIP CEO Catherine Duggan.

The organisation said in a statement, “A world where everyone benefits from access to safe, effective, quality and affordable medicines and health technologies, as well as from pharmaceutical care services provided by pharmacists, in collaboration with other healthcare professionals is the vision that FIP is working towards. FIP condemns all acts of violence or war causing suffering, and has long supported the pharmacy profession in humanitarian work.

“As healthcare professionals, pharmacists have an ethical duty and responsibility of providing aid to others in disaster situations.

We remind all our members and others of our Statement of Policy on the role of the pharmacist in the management of disasters, be they natural or man-made, war, civil disorder or pandemics. Our plans for support of those in need as a result of the war in Ukraine are set out below.”

FIP’s actions and what you can do

 Subsequent to Russia’s invasion of Ukraine on 24 February 2022, FIP has been in contact with the All-Ukrainian Pharmaceutical Chamber, as it is our custom to reach out to our member organisations in a time of tragedy.

 FIP is currently acting on a request from The All-Ukrainian Pharmaceutical Chamber to organise humanitarian aid, in line with our vision.

 FIP has obtained a list of aid products that are needed, developed by The Ukraine Ministry of Health.

Update from the All-Ukrainian Pharmaceutical Chamber

“Pharmacists in Ukraine continue to fulfill their mission in patient care, using the Ukrainian model of Good Pharmacy Practice, but now working with bulletproof vests over their white coats. In many attacked cities, pharmacies are closed due to a lack of pharmaceutical staff. There is an acute shortage of medicines, which is caused by the inability of distributors to deliver due to the constant shelling of all vehicles moving in the direction of cities and villages. However, Ukrainian pharmacists show, by their daily deeds at their workplaces, that pharmacy is one of the most accessible places for the general population where it is possible to receive first aid” — Oleg Klimov, AUPC chairman

 Oleksii Iaremenko, Deputy Minister of Health of Ukraine for European Integration, is coordinating the receipt of humanitarian goods (email: o.yaremenko@moz.gov.ua).

Meanwhile the PGEU has also released a statement.

European community pharmacists stand together to condemn Russia’s unprecedented military aggression against Ukraine and to share their strong solidarity with their Ukrainian colleagues and the Ukrainian people during these dark times.

They said, “The All-Ukrainian Pharmaceutical Chamber has described the impact of the war on the operations of community pharmacies in Ukraine in a call for actions against the Russian invasion. The heart-breaking report and pictures show that many pharmacies across the country have been forced to shut down or have been fully destroyed.

“Where pharmacies are still able to operate, pharmacists put their life at risk to continue to fulfil their mission in providing patient care. However, there is an acute shortage of medicines.

“The constant shelling of vehicles moving in the direction of cities and villages is preventing the distribution of products within Ukraine and the delivery of the medicines and devices stocked so far by humanitarian organizations in the neighbouring countries.

“Therefore, PGEU calls to guarantee continue access to medicines to all those affected by this war and to establish with the highest priority safe humanitarian corridors to allow essential medical equipment to reach conflict zones.

“We also call on all community pharmacists across Europe to continue supporting initiatives launched by their national pharmaceutical associations and/or support international humanitarian organisations working in the field and with refugees through financial donations. PGEU remains strongly committed to working closely with the European Commission’s humanitarian services and with all the other European health care stakeholder organisations to provide support in any way that can help alleviating some of the most pressing urgencies for the provision of health care and other basic life support.”

organisations across Europe and indeed the world, are calling on pharmacists to provide aid to Ukraine.

Pharmacy Steps Up to Support Ukraine

Community pharmacies across Ireland have once again stepped up to show their support for Ukraine, organising first aid, clothing and medical supplies to be donated and transported to the people of Ukraine who are desperately in need.

tirelessly to help the people most affected by this horrible crisis. For more information on the work of the charities our funds are going to, please visit:

Irish Red Cross: https://lnkd.in/ e4hxhhVc

UNHCR: https://lnkd.in/gJF-9Av9

Whelehans Pharmacy recently compiled their first van load of medical and first aid supplies donated by the people of Mullingar. In a statement owner and Pharmacist Eamonn Brady explained, “These supplies will be transported by Smullen

Couriers ltd straight to Poland to support the people of Ukraine. This is in addition to the aid effort co-ordinated by Smullens and many more. Thanks to Natalie Slomyanovska for organising and co-ordinating the Whelehans Aid effort - a non-profit cause. We will have more deliveries like this in the coming weeks and Whelehans Pharmacy are also making a significant contribution of first aid supplies to the Ukranian cause.”

The pharmacy teams and support office colleagues at totalhealth and Haven Pharmacies have been shocked and saddened by the devasting crisis being faced by the people of Ukraine. They told Irish Pharmacy News, “In order to support humanitarian efforts on the ground, we are donating at total of ¤120,000 to the Irish Red Cross and UNHCR, who are working

Haleon – New Leader in Consumer Health

Cara Pharmacy were also collecting. Managing Director Patrick McCormack stated, “Well done to our team at CARA Pharmacy Dunlaoghaire who recently gave their own hard earned money to purchase goods to send to Ukraine. Essential medical supplies and toiletries have also been donated by CARA Pharmacy and the use of our vans to transport to central hub for onward transport to Poland and Ukraine.

“Our patients and customers can also donate at any totalhealth or Haven Pharmacy branch. Collection boxes will be available in every pharmacy, as well as the option to ‘tap and donate’ your chosen amount using your phone or payment card. 100% of all funds raised will be split equally between the Irish Red Cross and UNHCR.

“We are sincerely thankful to our pharmacy members for supporting this effort. This is truly a time for us to stand together with the people of Ukraine, both those in the midst of this catastrophe and their families who watch from afar – our deepest thoughts are with you all.”

GlaxoSmithKline plc (GSK) has announced that the new company, to result from the proposed demerger of Consumer Healthcare from GSK in mid-2022, will be called Haleon.

Haleon (pronounced “Hay-LeeOn”) is inspired by the merging of the words ‘Hale’, which is an old English word that means ‘in good health’ and Leon, which is associated with the word ‘strength’. The new brand identity was developed with input from employees, healthcare practitioners and consumers and will be deployed in more than 100 markets around the world where the business operates.

The creation of Haleon results from a series of successful investments and strategic changes to GSK’s consumer health business over the last 8 years, including integrations

of the consumer product portfolios from Novartis and Pfizer.

As a standalone company, Haleon will be a new world-leader in consumer healthcare, offering a compelling proposition – to bring deep human understanding together with trusted science – to deliver better everyday health with humanity.

In Ireland, GSK Consumer Healthcare employs 930 people.

900 are located in Dungarvan, while a 30 strong sales and commercial team based in Dublin manage the Consumer Healthcare portfolio of products

and sell to customers in Ireland. Dungarvan is one of the largest manufacturing sites in GSK’s Consumer Health network.

Dave Barrett, Country Manager of GSK Consumer Healthcare in Ireland, added, “I am delighted to drive this exciting chapter in our company history together with the fantastic Ireland team. We will continue to be an important partner for consumers, customers and healthcare practitioners to ensure Haleon delivers better everyday health with humanity. We are very proud of our market leading and globally trusted brands, including household

names like Sensodyne, Corsodyl, Centrum, and of course Panadol which is made in Ireland.

“Over the past forty years, our Panadol facility in Dungarvan has become one of the largest manufacturing sites in GSK’s Consumer Health network, producing both ‘over the counter’ pain relief and oral healthcare products for global supply to over 70 markets. We are well positioned to grow our business in Ireland over the coming years, and we look forward to keeping our teams in Dublin and Waterford updated every step of the way.”

DUAL ACTION

References: 1. Merry A, et al. AFT-MX-1, a prospective parallel group, double-blind comparison of the analgesic effect of a combination of paracetamol and ibuprofen, paracetamol alone, or ibuprofen alone in patients with post-operative pain. Department of Anaesthesiology, University of Auckland, New Zealand 2008. *compared with the same daily dose of standard paracetamol or ibuprofen alone. Easolief Duo 500 mg/150 mg film-coated tablets Each tablet contains paracetamol 500 mg and ibuprofen 150 mg. Presentation: A White, capsule shaped tablet with breakline on one side and plain on the other side. Indications: Short-term symptomatic treatment of mild to moderate pain. Dosage: Adults/elderly: The usual dosage is one to two tablets taken every six hours up to a maximum of six tablets in 24 hours. Children: Easolief Duo is contraindicated in children under 18 years.

Contraindications: Severe heart failure, known hypersensitivity to paracetamol, ibuprofen, other NSAIDs or to any of the excipients, active alcoholism, asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs, history of gastrointestinal bleeding or perforation related to previous NSAID therapy, active or history of recurrent peptic ulceration/ haemorrhage, severe hepatic failure or severe renal failure, cerebrovascular or other active bleeding, blood-formation disturbances, during the third trimester of pregnancy. Warnings and precautions: This medicine is for short term use and is not recommended for use beyond 3 days. Clinical studies suggest that use of ibuprofen, particularly at a high dose may be associated with a small increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses should be avoided. Careful consideration should be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events. The use of paracetamol at higher than recommended doses can lead to hepatotoxicity, hepatic failure and death. Patients with impaired liver function or a history of liver disease or who are on long term ibuprofen or paracetamol therapy should have hepatic function monitored at regular intervals. Severe hepatic reactions, including jaundice and cases of fatal hepatitis, though rare, have been reported with ibuprofen. Paracetamol can be used in patients with chronic renal disease without dosage adjustment. There is minimal risk of paracetamol toxicity in patients with moderate to severe renal failure. Caution should be used when initiating treatment with ibuprofen in patients with dehydration. The use of an ACE

inhibiting drug, an anti-inflammatory drug and thiazide diuretic at the same time increases the risk of renal impairment. Blood dyscrasias have been rarely reported. Patients on long-term therapy with ibuprofen should have regular haematological monitoring. Like other NSAIDs, ibuprofen can inhibit platelet aggregation. GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered. Use with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided. NSAIDs may lead to onset of new hypertension or worsening of pre-existing hypertension and patients taking antihypertensive medicines with NSAIDs may have an impaired anti-hypertensive response. Fluid retention and oedema have been observed in some patients taking NSAIDs. NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis and Stevens-Johnson syndrome. Products containing ibuprofen should not be administered to patients with acetylsalicylic acid sensitive asthma and should be used with caution in patients with pre-existing asthma. Adverse ophthalmological effects have been observed with NSAIDs. For products containing ibuprofen aseptic meningitis has been reported only rarely. NSAIDs may mask symptoms of infection and fever. Interactions: Warfarin, medicines to treat epilepsy, chloramphenicol, probenecid, zidovudine, medicines used to treat tuberculosis such as isoniazid, acetylsalicylic acid, other NSAIDs, medicines to treat high blood pressure or other heart conditions, diuretics, lithium, methotrexate, corticosteroids. Refer to summary of product characteristics for other interactions. Fertility, pregnancy and lactation: Easolief Duo is contraindicated during the third trimester of pregnancy. Driving and operation of machinery: Dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected patients should not drive or operate machinery. Undesirable effects: Dizziness, headache, nervousness, tinnitus, oedema, fluid retention, abdominal pain, diarrhoea, dyspepsia, nausea, stomach discomfort, vomiting, flatulence, constipation, slight gastrointestinal blood loss, rash, pruritus, alanine aminotransferase increased, gamma-glutamyltransferase increased, abnormal liver function tests, blood creatinine increased and blood urea increased. Refer to Summary of Product Characteristics for other adverse effects. Pack size: 24 tablets. Marketing authorisation holder: Clonmel Healthcare Ltd.,

Milestones in totalhealth Pharmacies!

Nuala O’Donnell Johnson and Ian Johnson have been running O’Donnell’s totalhealth Pharmacy, Charlestown, Co. Mayo since they took over the business from Nuala’s parents, Jack and Nancy O’Donnell, in 1997. The recently reached a milestone when they celebrated 25 years in business.

Speaking in their pharmacy, Nuala & Ian said “March 1st 2022 marks the 25th anniversary of that initial purchase, and along with all the staff we are delighted to have been at the forefront of community pharmacy in Charlestown. Most of the team has been with us over 10 years, and two of them over 20 years, which we hope says something about the way we look after our people. Every team member looks after us and treats the business as if it were their own, which is very reassuring these days. Does it feel like 25 years? Yes and no! It’s certainly gone quickly, and we don’t think of ourselves being that age. But we are, and we have two daughters, Heather and Sophie, in their early 20s, and they certainly try to keep us young. It was great to see the positive response on social media for our 25th anniversary. It makes you realise that you are making a difference to peoples’ lives, maybe only in a small way locally, but it’s a difference for the better”

Aoife O’Connor and Paula Kelly from Natural Options totalhealth Pharmacy, Boyle, Co. Roscommon celebrated their 2-year anniversary in February 2022.

World Obesity Day

World Obesity Day was held recently on Friday March 4th 2022. This is an annual, global event to bring people together to raise awareness and increase knowledge about obesity and the many other diseases on which it impacts. This year’s theme was ‘Everybody Needs to Act.’

On 4th March 2021, the Model of Care for the Management of Overweight and Obesity in Ireland was launched. This sets out the services needed to provide end to end care for prevention and treatment of overweight and obesity in children, young people and adults.

The Model of Care for Children and Young People recommends the implementation of end to end supports for childhood obesity prevention and treatment. The new weight management programmes will see multidisciplinary teams providing specialist assessment and treatment for children, young people and their families. This includes individual and group programmes, links to local community programmes for additional support and onward referral to hospital based teams as necessary.

Aoife, Paula and their team shared their excitement and gratitude on their Facebook page; “We are beyond grateful to all of you who have supported us in so many ways. We feel extremely lucky to share this journey with our wonderful colleagues and friends and the lovely people we meet who come into our shop each day. The past two years have brought us challenges we never could have imagined back on the 21st of February 2020.

A week in and Covid-19 threw our world upside down. Two years later we have expanded and grown our space, our team, and our love for what we do. We have dispensed medicines, vaccinated, dressed wounds, provided a listening ear, and have always tried to do our best with a smile, with empathy and with kindness. We look forward to the years ahead as we continue to grow, to improve and to learn. Thank you all.”

Enhanced Community Care forms part of the adult Model of Care implementation. This programme is ensuring maximum impact for citizens in avoiding hospital admission as far as possible through initiatives that see care delivered within the community, at or near a person’s home where appropriate. In 2022, dietitians will commence delivery of community based adult weight management programmes in community healthcare networks across the country allowing individuals with obesity to access dedicated healthcare professionals for support in their community.

The recent 2022 Waiting List Action Plan, the first year of a multi-annual reform programme to stabilise and reduce waiting lists and improve access to services has identified implementation of obesity care pathways as a priority. It will provide funding in 2022 to increase access and capacity nationally to specialist services including bariatric surgery, providing specialist care in the right place at the right time.

Examining Sector Stability and Patient Access to Medicines

The Guaranteed Irish Annual Pharmaceutical Forum, sponsored by MSD Ireland, featured an industry leading line-up within the pharmaceutical sector. Hosted by Mairead McCaul Managing Director of MSD Ireland Human Health, the panel discussion featured industry thought leaders Dr. Thorsten Giesecke General Manager Commercial Business at Janssen Sciences Ireland, and Matt Moran Director of BioPharmaChem Ireland, Ibec.

and commitment these companies have to Ireland.”

range of medical conditions will be proposed. These conditions include arthritis, multiple sclerosis, psoriasis and many forms of cancer…these medicines could treat almost 17,500 patients here in Ireland” said Mairead McCaul Managing Director of MSD Ireland Human Health.

Sector stability remains an attraction for Ireland as a hub for pharmaceuticals globally. Matt Moran Director of BioPharmaChem Ireland, Ibec added “…as well as being an industry dominated by foreign direct investment, it’s an extremely stable sector. Multinationals pay around ¤15 billion in corporation tax, and it’s the security which this brings that is very important.”

in Europe, most of which are made in Ireland, are available to patients in Ireland. This is an opportunity where if Government looks at the industry holistically to include manufacturing, clinical research and the domestic health service, they can drive this eco-system.”

The panel outlined Ireland’s position as the third largest exporter of pharmaceuticals globally, employing over 45,000 people in Ireland directly with an added growth value of ¤15 billion to the local economy. “This year, 35 new medicines for a

The panel discussed sector opportunities including sector stability, continuous growth & development, the sector’s commitment to nurturing talent, and harnessing a holistic pharma-healthcare ecosystem. Examining these trends, Mairead McCaul affirmed “…we have a well and proven track record as a successful location for highgrowth multinationals. One-third of multinationals in Ireland have been here for over 20 years, showing the longevity, resilience

The panel also highlighted industry challenges such as the disconnect between Government policy and the pharmaceutical sector, as well as the delayed reimbursement of Gene and Cell Therapy (GCT). While Ireland is a global leader in the pharmaceutical industry, patient access to medicines is somewhat limited. According to Thorsten Giesecke General Manager Commercial Business at Janssen Sciences Ireland, “Studies have shown 35% of medicines licensed

40% of Dementias Preventable

Closing the event, Mairead McCaul Managing Director, MSD Ireland Human Health said, “I’m delighted to have been part of this thought -provoking and insightful discussion this morning. Events such as this facilitate crucial discussions with fellow industry experts to explore how we can build on our past and current success as an industry and continue to thrive and hold our place as a global leader in the pharmaceutical industry. MSD Ireland is a long-standing member of Guaranteed Irish and acknowledges the role it plays in promoting Ireland and facilitating networking opportunities such as this.”

Up to 40% of dementias are preventable highlighting the need to resource early intervention, awareness and new treatments – a special Oireachtas briefing led by The Alzheimer Society of Ireland (ASI) has been told.

Speaking at the event hosted by The All Party Oireachtas Group on Dementia in advance of Brain Awareness Week (March 14-20), The ASI, clinicians, academics, and the Global Brain Health Institute showcased opportunities to increase prevention and significant developments in medical treatments.

The ASI Interim CEO Siobhan O’Connor said, “If we address early risk factors such as hearing loss, high blood pressure, diabetes, smoking and depression then – according to the Lancet Commission – 40% of dementias are preventable. There are interventions which can reverse cognitive decline through education, exercise, stimulation, and social engagement. And further to this, there are a suite of significant new medical treatments becoming available which slow down early onset.”

Addressing Oireachtas members, Faculty Member of the Global

Pictured Professor Iracema Leroi, Professor Sean Kennelly. Senator Fiona O’Loughlin, Mr Kevin Quaid, Professor Mary McCarron, Ms Samanatha Taylor, Ms Siobhan O’Connor. Professor Sean Kennelly told Oireachtas members that up to 40% of dementias are preventable, highlighting the need to resource early intervention, awareness and new treatments, at a special Oireachtas briefing hosted by the All Party Oireachtas Group on Dementia led by The Alzheimer Society of Ireland (ASI). Particular focus is needed on preventing dementia among people with intellectual disabilities.

Picture: Finbarr O’Rourke

Brain Health Institute and Consultant in Physician Geriatric and Stroke Medicine at Tallaght Hospital Professor Sean Kennelly said, “Dementia is the most significant health condition globally for which we have no definitive treatments, but we are now at

the cusp of a new era of better interventions to prevent, diagnose, and treat Alzheimer’s disease and other dementias. It’s imperative that we educate people, so they understand what a ‘brain-healthy’ lifestyle is, and to take action to reduce the risks.”

Siobhan O’Connor concluded by welcoming funding as part of the HSE’s National Service Plan 2022 to facilitate the recruitment of a Project Manager in Brain Health, due to commence with the National Dementia Office (NDO) in July this year.

Strength of Balance

Indicated for the treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to, or are intolerant to one or more disease modifying anti-rheumatic drugs.1 May be used as monotherapy or in combination with methotrexate.1

Refer to Summary of Product Characteristics (SmPC) before prescribing, and for full prescribing information.

JYSELECA® filgotinib 100 mg or 200 mg film-coated tablets. Indication: Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). Dosage: Adults: 200 mg once daily. Taken orally with/without food. It is recommended that tablets are swallowed whole. Laboratory Monitoring: Refer to the SmPC for information regarding laboratory monitoring and dose initiation or interruption. Elderly: A starting dose of 100 mg once daily is recommended for patients aged 75 years and older as clinical experience is limited. Renal impairment: No dose adjustment required in patients with estimated creatinine clearance (CrCl) ≥ 60 mL/min. A dose of 100 mg of filgotinib once daily is recommended for patients with moderate or severe renal impairment (CrCl 15 to < 60 mL/min). Not recommended in patients with CrCl < 15 mL/min. Hepatic impairment: Mild/moderate hepatic impairment: no dose adjustment required. Severe hepatic impairment: not recommended. Children (< 18years): Safety and efficacy not yet established. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active tuberculosis (TB) or active serious infections. Pregnancy. Warnings/Precautions: See SmPC for full information. Immunosuppression: Combination use, with immunosuppressants e.g. azathioprine, ciclosporin, tacrolimus, or biologic DMARDs (bDMARDs) or other Janus kinase (JAK) inhibitors is not recommended as a risk of additive

immunosuppression cannot be excluded. Infections: Infections, including serious infections such as pneumonia and opportunistic infections e.g. tuberculosis (TB), oesophageal candidiasis, and cryptococcosis have been reported. Risk benefit should be assessed prior to initiating in patients with risk factors for infections (see SmPC). Patients should be closely monitored for the development of signs and symptoms of infections during and after filgotinib treatment. Treatment should be interrupted if the patient is not responding to antimicrobial therapy, until infection is controlled. There is a higher incidence of serious infections in the elderly aged 75 years and older, caution should be used when treating this population. Tuberculosis: Patients should be screened for TB before initiating filgotinib, and filgotinib should not be administered to patients with active TB. Viral reactivation: Cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies (see SmPC). If a patient develops herpes zoster, filgotinib treatment should be temporarily interrupted until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed. Malignancy: Immunomodulatory medicinal products may increase the risk of malignancies. Malignancies were observed in clinical studies (see SmPC). Fertility: In animal studies, decreased fertility, impaired spermatogenesis, and histopathological effects on male reproductive organs were observed (see SmPC). The potential effect of filgotinib on sperm production and male fertility in humans is currently unknown. Haematological abnormalities: Do not start therapy, or temporarily stop, if Absolute Neutrophil Count (ANC) <1 × 109 cells/L, ALC <0.5 × 109 cells/L or haemoglobin <8 g/dL. Temporarily stop therapy if these values are observed during routine patient

JYSELECA – a preferential JAK1 inhibitor for moderate to severe RA1

JYSELECA shows more than 5x greater potency for JAK1 over JAK2/3 and TYK21*

Balancing sustained efficacy2-6 with acceptable tolerability1,7

Visit

management. Vaccinations: Use of live vaccines during, or immediately prior to, filgotinib treatment is not recommended. Lipids: Treatment with filgotinib was associated with dose dependent increases in lipid parameters, including total cholesterol, and high-density lipoprotein (HDL) levels, while low density lipoprotein (LDL) levels were slightly increased (see SmPC). Cardiovascular risk: Rheumatoid arthritis patients have an increased risk for cardiovascular disorders. Patients should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care. Venous thromboembolism: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors including filgotinib. Caution should be used in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery, and prolonged immobilisation. Lactose content: Contains lactose; patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take filgotinib. Pregnancy/ Lactation: Filgotinib is contraindicated in pregnancy. Filgotinib should not be used during breast-feeding. Women of childbearing potential must use effective contraception during and for at least 1 week after cessation of treatment. Driving/Using machinery: No or negligible influence, however dizziness has been reported. Side effects: See SmPC for full information. Common (≥1/100 to <1/10): nausea, upper respiratory tract infection, urinary tract infection and dizziness. Uncommon (≥1/1000 to <1/100): herpes zoster, pneumonia, neutropenia, hypercholesterolaemia and blood creatine phosphokinase increase. Serious side effects: See SmPC for full information Legal category: POM Pack:

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30 film-coated tablets/bottle Price: UK Basic NHS cost: £863.10; Ireland: POA Marketing authorisation number(s): Jyseleca 100mg film-coated tablets

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Adverse events should also be reported to Galapagos via email to Drug.safety.UK.Ireland@glpg.com or 00800 7878 1345

Adverse events should be reported. For Ireland, reporting forms and information can be found at www.hpra.ie and can be reported to HPRA on +353 1 6764971.

Against

The Common Issue of Head Lice

Pediculus humanus capitis, is the scientific name for lice and we call Pediculosis the affection of lice. It is a parasitic insect that can be found on the head, eyebrows, and eyelashes of people. Its main feed is the human blood and they live close to the human scalp staying attached on the hair.

However, the eradication or elimination of local outbreaks and therefore of possible epidemics, requires measures that are more complex. The health and care information as to how to do this is freely made available through the education and awareness of schoolchildren, parents and educators. A child infected with lice scratches their head and when parents start getting alerts from the school informing them that it has been diagnosed, some of their classmates often panic. This can causes tremendous disruption within the household as parents must, every night, check everyone’s hair including their own, meticulously combing and treating. This can take up to 2-3 hours per night. In addition, those within the household who also suffer from other conditions may find it additionally stressful. Parents must take the risk that once their child’s headlice has cleared up, there is a high risk of re-infection once they return to school and so in this regard, head lice are a common, repetitive cause for concern.

Head lice are spread via direct contact with the hair from an infected person so they cannot hop or fly. Those at greatest risk have had head to head contact or comes close to an infected individual. Whilst uncommon, sharing clothing is also a risk such as hats, scarves, coats, combs, brushes, or towels used by an infected person. Lice cannot live more than 24hours out, but there is a high probability of catching an infection.

Head lice mostly proliferate in the school and educational activity settings, due to the greater number of children concentrated in each classroom or playground and the longer contact time.

Head lice can become a cause of bullying or harassment in school, since the population erroneously associates this condition with a hygiene problem or social class.

It is generally agreed that in children head lice are not related to hygiene, however it might be in adults. Adults and children who do not attend a school setting may also be infected in other situations, especially throughout the global family. In general, it can be stated that the household - understood as the group of people that constitute a family group - is the maintenance of the disease and the school is the propagation medium.

Clinically, head lice can be asymptomatic. The pruritus is the most common symptom. Furthermore, this can sometimes prove to be so intense that, when scratched, it causes erosions in the skin and subsequent bacterial infections. In this situation, the scalp is suffering and in need of treatment. Fundamentally, the control of the pediculosis is the healing of each infected individual

that is part of the affected social group, through the total elimination of all living phases of lice. This is achieved by treating individually using chemical pediculicides or other extraction and disposal techniques.

Pediculosis is a widespread social problem in all human populations. Although at family level it is often a reason for anguish, your assessment should not be alarmist about the consequences and meaning of the illness.

Currently there are many products, such as shampoos, lotions and creams, designed specifically to combat lice. However, it must be borne in mind that they are products with an insecticidal action and they must be used scrupulously following the instructions on the package insert for them to be effective. If the lice is still resist treatment, it is possible to resort to oral treatments.

At the end of any treatment, it will be necessary to remove the remaining nits with a fine-toothed comb and maintain the use of the antiparasitic shampoo or lotion for some time. For children under two years of age, this type of product should not be used and it is best to remove nits and lice by hand, combing through wet hair with a fine-toothed pin. It will be necessary to repeat the operation, with intervals of two or three days, for at least for two weeks after having seen the last louse.

Consequently, having children at home with lice is often an anguish for many, since treatment and maintenance is a tedious processes in the family nucleus.

Ana

“Pediculosis is a widespread social problem in all human populations. Although to family level is often a reason for anguish, your assessment should not be alarmist in about the consequences and meaning of the illness”

Pharmacy Supports Kidney Disease Screening

Pharmacists are being called on to offer their support to a new campaign highlighting the importance of screening for early detection of Chronic Kidney Disease.

Itchy Scalp: Scratching for an Explanation

Scalp pruritus is a common complaint that is considered a diagnostically and therapeutically challenging situation. Scalp skin has a unique neural structure that contains densely innervated hair follicles and dermal vasculature.

Chronic Kidney Disease (CKD) affects 1 in 10 people in the whole population. Often described as ‘a silent illness hiding in plain sight’, it usually develops slowly over time and can progress to total kidney failure. It is estimated that CKD will become the fifth leading cause of death globally by 2040.

Over 500 people in Ireland develop kidney failure every year.

World Kidney Day which was celebrated on 10th March 2022 aims to bridge the knowledge gap to better kidney care. To mark World Kidney Day, the Irish Kidney Association (IKA), in association with the HSE’s National Renal Office (NRO) and Diabetes Ireland ran an awareness campaign to highlight the importance of screening for early detection of Chronic Kidney Disease (CKD).

The success of the campaign has relied on the valued support of healthcare professionals including GPs and Pharmacists. The Irish Pharmacy Union is supporting

the campaign through sharing its message on its digital and print platforms. Some independent pharmacy chains are also promoting the campaign to their customers. The collaboration between all these interest groups in supporting the campaign is an indicator of the importance of monitoring kidney health.

Diabetes Ireland welcomes the opportunity to join with the Irish Kidney Association to share this important messaging in their –Check Know Discuss campaign to highlight the need for people living with Diabetes to be aware of their kidney health as Diabetes is one of the leading causes of Chronic Kidney Disease worldwide.

Chronic Kidney Disease is a condition that has the potential to go undetected as it does not cause symptoms in the early stages. It is a condition that can be screened for by getting urine and blood tests to monitor kidney function. These simple urine and blood tests are a

routine part of Diabetes care with your GP/diabetes team.

Risk factors towards developing Chronic Kidney Disease (CKD) include:

 Diabetes

 Hypertension (High blood pressure)

 Cardiovascular Disease

 Cancer

 Liver conditions

 Autoimmune diseases

 Pre-eclampsia

 Obesity

 Family health history of kidney disease

 Aged over 50

 Long term use of over-the-counter medications

In explaining why Diabetes Ireland is supporting the Irish Kidney Association in its campaign, Clair Naughton, Diabetes Nurse and Regional Development Officer with Diabetes Ireland said, “Diabetes Ireland welcomes the opportunity to highlight the importance of screening for Chronic Kidney Disease, a condition that can go undetected in the early stages as it doesn’t cause symptoms. Diabetes, which affects in excess of 250,000 people in Ireland is one of the leading causes of Chronic Kidney Disease. Diabetes checkups should include the routine monitoring of kidney function so that changes can be picked up early. It is easily done with routine kidney blood and urine tests. Diabetes Ireland is urging all people with diabetes to attend for their routine diabetes check-ups with their GP or diabetes team, to ask for a kidney function test, and ensure that a discussion of kidney health becomes an integral part of check-ups. Find out the results of the test and regularly discuss their kidney health with their doctors: i.e. Check, Know, Discuss”.

Scalp pruritus is a common and distressing symptom. It is most commonly associated with seborrheic dermatitis and psoriasis but appears often without any noticeable skin lesion or obvious diagnosis. It is considered a diagnostically and therapeutically challenging situation particularly when no other body part itches and no detectable lesion seen.

The first step in treating pruritus is finding the source of the itch. Potential causes include medications or pregnancy.

Scalp pruritus can arise from a variety of conditions including dermatologic, systemic, neurologic and psychogenic diseases. Among patients with psychogenic pruritus, the most commonly affected sites are scalp and face.

Certain groups of people are more susceptible to pruritus, including:

• The elderly

• Atopic patients (seasonal allergies, hay fever, asthma, and eczema)

• People with diseases, including diabetes, HIV infection/AIDS and various types of cancer

• Pregnant women

• Patients with kidney failure on dialysis

Scalp itch continues to be a major symptom for dermatologic patients. The scalp has a complex neuroanatomy with abundance of sensory neural end organs in the pilosebacous unit. Because ‘itchy scalp’ is a common complaint with disparate origins; namely dermatologic, neuropathic, systemic and psychogenic; dissecting these neural circuits, their anatomical and physiologic role in itch is of prime importance. Understanding the unique features of itch circuit in the scalp is key to development of effective therapies.

Practicing healthy skincare habits can help prevent pruritus. This includes eating a healthy diet and protecting skin from excessive damage. Drinking plenty of water, moisturising to prevent dry skin, using warm (rather than hot) water for washing, and applying adequate sunscreen are also good habits for the skin.

Caring for Women with Epilepsy in your Pharmacy

Dr Nicola Maher has a special interest in medical conditions in pregnancy and in particular epilepsy. Together with Sinead Murphy Advanced Nurse Practitioner in Epilepsy they run a dedicated antenatal service for women with epilepsy. Patients are seen throughout their pregnancy and preconceptual counselling is also provided. Dr Maher also is a member of the Irish Medicines in Pregnancy Service (IMPS), a multidisciplinary service based at the Rotunda Hospital which provides information and expertise to support safe and effective use of medicines before, during and after pregnancy.

In Ireland approximately 25% (10000) of all people diagnosed with epilepsy are women of childbearing potential. Pharmacists are among the most trusted professions by society and are ideally placed to support and advise women who maybe planning a pregnancy or indeed are pregnant. Whether at the point of collecting prescribed regular anti-seizure medication or indeed at initiation or ceasing of contraception, opportunities exist for pharmacists to discuss pregnancy in women with epilepsy.

Fortunately most women with epilepsy remain well during their pregnancy. However, up to 30% of women with epilepsy will notice a worsening of seizure control in pregnancy which can place mothers and their unborn babies at risk during the pregnancy. Some of the most commonly prescribed anti-seizure medications enjoy excellent safety profiles. None the less pregnant women often have significant anxiety around taking medication. The legacy of Valproate and the general cautions and warnings that surround medication use in pregnancy have led to many women choosing to stop medications without advice from their doctor or pharmacist.

Poorly controlled epilepsy is not without serious risk to pregnant women. While these are rare, many are often preventable. Maternal mortality reports across the UK and Ireland frequently refer to maternal deaths where patients had stopped their medication due to pregnancy. Ensuring patients are fully informed of the often reassuring safety profile of their medication and providing them with accurate, up to date information are key to caring for women with epilepsy. Patients with epilepsy should be advised not to stop taking their anti-seizure medication without first speaking to their doctor.

Pre Pregnancy

All women planning a pregnancy should be offered preconceptual counselling with their neurology service and an obstetrician. This affords the opportunity to review medications and assess seizure history as well as perform serum drug levels if needed. Women with epilepsy of childbearing potential should be prescribed

Folic Acid 5mg daily to reduce the incidence of neural tube defects which can be higher with some anti-seizure medications.

Contraception choice in women with epilepsy depends on their antiseizure medication. Carbamazepine for example a cytochrome enzyme inducer can lead to reduced efficacy of the combined oral contraception. Lamotrigine levels can be affected by the combined oral contraceptive pill and can lead to toxicity side effects on the pill free interval. The FSRH have excellent guidance on contraceptive use for women taking anti-seizure medication.

Nausea and Vomiting in Pregnant Women with Epilepsy

Many women experience infrequent nausea and vomiting in pregnancy and this can place women at epilepsy at risk of seizures due to lost medication doses. As a general rule, if a woman vomits within one hour of taking her anti-seizure medications a second dose can be taken. If persistent vomiting is a problem, women should see their GP or visit their obstetric caregiver. Effective antiemetics are essential in managing hyperemesis in pregnancy which can affect up to 3% of all pregnant women.

Anti-Seizure Medications Safety Profiles

LAMOTRIGINE AND LEVETIRACETAM are amongst the most commonly prescribed antiseizure medications in use today and pose no additional risks to the fetus in pregnancy. The background rate of all congenital anomalies (babies born with structural birth defects) in pregnancy is approximately 2% and neither of these drugs affect this rate. Patients taking these medications should be reassured that they are safe to take in pregnancy and that they should be encouraged to continue to take their medications to reduce seizure risks. Studies in relation to risk of developmental delay are also reassuring.

CARBAMAZEPINE, TOPIRAMATE and PHENYTOIN

Carbamazepine is a very effective anti-seizure medication. Many women who take carbamazepine have very well controlled epilepsy for years. Carbamazepine confers a small additional risk to the fetus

in pregnancy. The congenital anomaly rate associated with Carbamazepine use in pregnancy is 4-5%. Similarly Topiramate which is less commonly prescribed for epilepsy confers a risk of approximately 6% of congenital abnormality. Women being prescribed these medications would especially benefit from preconceptual consultations with their neurologist and obstetrician. Individualised risk benefit discussions can be made to discuss medication best suited to the woman to optimise seizure control, while minimising risks of congenital anomaly. Phenytoin, less commonly prescribed is associated with a 6% risk of congenital anomaly. Studies in relation to developmental delay with these medication are contradictory and a risk cannot be excluded.

SODIUM VALPROATE. A pregnancy prevention programme is in existence in Ireland since 2018 for Valproate containing medications. Children exposed in utero have up to 40% risk of serious developmental disorders in addition to 10% risk of congenital abnormality. It is important that any woman prescribed Valproate does not stop taking it without consulting their doctor. Should a woman who is taking valproate become pregnant an urgent review with a neurologist should be arranged. Lacosamide, Brivaracetam, eslicarbamazepine, clozapam, zonisamide, gabapentin and pregabalin.

There is not enough data to confirm or rule out any additional risks in pregnancy in women taking the above medication. These are second line agents often used where other treatments have been unsuccessful in controlling seizures. Studies are ongoing to evaluate their safety profile in pregnancy. The absence of this data does not equate to known harm for the fetus and again women should be advised not to stop their medication without consulting with their doctor.

Serum Drug Levels - what role do they play?

Physiologic and pharmacokinetics changes in pregnancy (e.g. increased volume of distribution, changes to renal elimination, altered hepatic enzymes) may alter serum plasma levels of anti-

seizure medication in pregnancy. Lamotrigine and Levetiracetam are particularly susceptible to variation in serum plasma level, especially in the third trimester and regularly require increased dosages in latter stages of pregnancy.

Ideally a pre-pregnancy serum level at a time of good seizure control or an early pregnancy level is taken in order to have a target pregnancy level. Levels are then repeated each trimester to maintain target levels. Often patients will remain on a higher dose for the initial two weeks postpartum due to the increased fatigue related seizure risk at this time. Any postpartum dose changes should be made following consultation with their neurology team. It should be noted that the use of drug levels varies in clinical practice and some studies do not support routine use. Should a pregnant woman experience a seizure a drug level is always taken and doses often increased prior to the result being available.

Thankfully pregnancy for most women with epilepsy remains uncomplicated and they are not at increased risk of any obstetric complications of pregnancy.

Maintaining seizure control while providing up to date information on medication safety profiles are key to the care of women with epilepsy in pregnancy.

30% of infants experience symptoms of regurgitation1

For bottlefed infants with frequent regurgitation

ESPGHAN * RECOMMENDS 2

a stepped-care approach...

REVIEW the feeding history. REDUCE the feed volumes by trialling smaller, more frequent feeds (while maintaining an appropriate daily total). TRIAL a thickened formula.

* European Society for Pediatric Gastroenterology, Hepatology, and Nutrition

References: 1. Vandenplas Y et al., Prevalence and health outcomes of functional gastrointestinal symptoms in infants from birth to 12 months of age. J Pediatr Gastroenterol Nutr 2015; Nov 61(5):531-7. 2. Rosen R et al., Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. JPGN 2018;66: 516–554. 3. Wenzl TG et al. Effects of thickened feeding on gastroesophageal reflux in infants: a placebo-controlled crossover study using intraluminal impedance. J Paediatr 2003;111(4):e355-9.

WHY MEDICATE?

TRY NUTRITION FIRST.

Aptamil Anti-Reflux is a thickened formula for the dietary management of reflux and regurgitation in bottlefed infants

Clinically proven to reduce infant regurgitation episodes by 78%3

For any queries or additional information please contact hcp@aptamil.com or call 1800 22 1234

Aptamil Anti-Reflux is available in 800g EaZypack ORDER TODAY FROM UNITED DRUG OR UNIPHAR

IMPORTANT NOTICE: Breastfeeding is best. Aptamil Anti-Reflux is a food for special medical purposes for the dietary management of frequent reflux and regurgitation. It should only be used under medical supervision, after full consideration of the feeding options available including breastfeeding. Suitable for use as the sole source of nutrition for infants from birth and as part of a balanced diet from 6-12 months. This product should not be used in combination with antacids or other thickeners and is not suitable for premature infants. Refer to label for details.

Diabetes Footcare and Complications

New diabetes footcare statistics data published, obtained by Roisin Shortall TD, shows that 608 people with diabetes underwent a lower limb amputation in 2020, accounting for 69% of the total procedures carried out in the year. There was a further 2,536 people with diabetes hospitalised requiring foot ulceration treatment spending on average 14 days in hospital for treatment in 2020.

Despite limited access to diabetes review appointments during the past 2 years, it seems from this data that diabetes related amputations and diabetes foot ulceration in patient numbers remain high year on year.

Diabetes Ireland is encouraging adults of all ages who have diabetes to ensure they have a full and proper foot assessment by a podiatrist or other appropriate healthcare professional. People with diabetes have special reason to take good care of their feet. Long term high blood glucose levels may make feet susceptible to injury and infection. This is because the protective sensation in the toes or feet, the “pain alarm system” may slowly disappear due to long term exposure to high blood glucose levels.

The latest data provides a county-by-county breakdown of both diabetes related lower limb

amputations and diabetes foot ulceration in patient numbers over the period 2016-2020.

With such high numbers, Diabetes Ireland is asking people with diabetes to be proactive by booking a foot assessment which will identify any problems and allow treatment to be undertaken early thus preventing more serious problems from occurring. It recommends that people should examine their feet daily and be on the lookout for small cuts, changes

Diabetes Footcare Statistics 2016-2020

in skin colour and temperature, red areas and swelling. They also must check they have continuing sensation in their feet and be alert

AMPUTATIONS

100 Years of Insulin

to signs such as prickly pain in the feet, numbness and peculiar sensations such as a feeling of walking on cotton or of wearing tight socks. This is important as without a pain alarm system, injuries and poor fitting shoes may go unnoticed.

Diabetes Ireland now has over 5,000 clients attending their preventative footcare services in Dublin & Cork. These services were set up to provide people with access to a high-quality and unique podiatry appointment service.

On January 23 1922, 14-year-old Leonard Thompson received the first successful insulin injection, which resulted in a drop in his blood glucose levels without any side effects. This day now marks a celebration of this major scientific breakthrough and the millions of lives that have been saved ever since.

One hundred years later, as well as ever more performing insulins, many new medicines and technologies have been developed, making a hugely positive impact on the lives of people living with diabetes (PwD).

We also know a lot more about the complexity of this disease, which, according to the World Health Organization (WHO), actually covers 14 distinct types, of which the most common are Type 1 and Type 2 Diabetes.

Extensive research and studies have demonstrated how both the risk of developing Type 2 diabetes and diabetesrelated complications and people’s ability to manage their diabetes optimally are

influenced by a multitude of often interlinked factors. In addition to non-modifiable genetic factors, these include modifiable risk factors such as a person’s socio, economic and environmental circumstances as well as external elements such as the structural organisation of care and the use of data, innovative tools, technologies and approaches by national health systems and people living with diabetes.

The socio-economic determinants of health themselves include factors that today represent some of the most pressing challenges in our societies, such as food insecurity, working life conditions, access to education, income, housing, and social inclusion.

It is evident that these determinants generate huge inequalities which have a negative impact on PwD’s lives. In Europe, such inequalities exist between and within countries and regions and represent an obstacle to the fulfilment of PwD’s fundamental right to the highest attainable

standard of health as stated by the WHO Constitution.

In this context, new technologies, tools and innovative approaches have the potential to revolutionise diabetes prevention, care and management and improve both the quality of life and the health outcomes of PwD.

The inherent complexity of diabetes prevention and management means, however, that the deployment of these new innovations and technologies must make inclusivity a priority and address the systemic issues of access that might affect their adoption. Alongside the increased use of novel tools and approaches, a holistic approach to diabetes prevention, care and management must also be implemented, taking into the account the need for improved integration of care; the provision of adequate support for PwD including focusing on mental health and emotional well-being; and the deployment of effective training, education and other support mechanisms for improved

self-management, including for example peer support and patient empowerment programmes.

On this day, the International Diabetes Federation Europe called on policy-makers and other stakeholders to come together to make diabetes a priority and improve the lives of PwD through:

• The promotion of a person-centred, and outcomes-based approach

• Further digitalisation of health services, and the provision of innovative tools and technologies

• The adoption of an integrated care system, including strengthening primary care

• The reduction of inequalities and improved access to the required diabetes medicines, supplies, technologies and care

• Greater PwD empowerment and engagement in their care, and

• Increased focus on prevention, health promotion and

action

Higher Risks of Diabetes for Children?

“Alternatively, Covid-19 might have indirectly increased diabetes risk through pandemic-associated increases in body mass index, a risk factor for both serious Covid-19 illness and diabetes.

Future studies addressing the role of comorbidities and increases in body mass index in post–Covid-19 diabetes are warranted. Although this study can provide information on the risk for diabetes following SARS-CoV-2 infection, additional data are needed to understand underlying pathogenic mechanisms, either those caused by SARS-CoV-2 infection itself or resulting from treatments, and whether a Covid-19–associated diabetes diagnosis is transient or leads to a chronic condition.

A heightened risk of diabetes has already been seen among adults who recovered from Covid-19, according to some studies. Researchers in Europe have reported an increase in the number of children being diagnosed with Type 1 diabetes since the pandemic started, the New York Times reported.

But the CDC study is among the first to examine large insurance claim databases in the US to estimate the prevalence of new diabetes diagnoses in children aged under 18 who had Covid-19 or were known to be infected with the coronavirus.

The study used two claim databases from the US health plans to look at diabetes diagnoses made in youngsters under 18 over a year or more, starting March 1, 2020,

comparing those who had Covid to those who didn't.

The researchers said, “New diabetes diagnoses were 166% (IQVIA) and 31% (HealthVerity) more likely to occur among patients with Covid-19 than among those without Covid-19 during the pandemic and 116% more likely to occur among those with Covid-19 than among those with ARI during the prepandemic period. Non–SARSCoV-2 respiratory infection was not associated with diabetes. These findings are consistent with previous research demonstrating an association between SARS-CoV-2 infection and diabetes in adults.

“The inclusion of only patients aged <18 years with a health care encounter possibly related to Covid-19 in the non–Covid-19 HealthVerity group could account

for the lower magnitude of increased diabetes risk in this group compared with risk in the IQVIA group. In addition, patients without Covid-19 in HealthVerity had higher hospitalization rates than did those in IQVIA, suggesting more severe disease at the index encounter in the HealthVerity comparison group.

“The observed association between diabetes and Covid-19 might be attributed to the effects of SARSCoV-2 infection on organ systems involved in diabetes risk. Covid-19 might lead to diabetes through direct attack of pancreatic cells expressing angiotensin converting enzyme 2 receptors, through stress hyperglycemia resulting from the cytokine storm and alterations in glucose metabolism caused by infection, or through precipitation of prediabetes to diabetes.

“Among persons aged <18 years with Covid-19 and new diabetes diagnoses in this study, nearly one half had DKA at or around the time of diagnosis. This number was higher than that in comparison groups, and higher than previous reports of DKA among incident type 1 diabetes cases before the pandemic (28%). Increased frequency of DKA at time of diagnosis of type 1 diabetes during the pandemic has previously been reported and was thought to be due to delayed care-seeking for diabetes. However, the observed association of increased risk for diabetes diagnosis following SARS-CoV-2 infection would not be explained solely by delayed care. “Health care providers should screen for diabetes symptoms in persons aged < 18 years with a history of SARS-CoV-2 infection. These symptoms can include frequent urination, increased thirst, increased hunger, weight loss, tiredness or fatigue, stomach pain, and nausea or vomiting.”

Children who have recovered from Covid-19 appear to be at an increased risk of developing Type 1 or Type 2 diabetes, researchers at the Centers for Disease Control and Prevention (CDC) have said.

Ireland’s new licensed fast-release, 3 mg melatonin drug

Melatonin is available on prescription in Ireland and we are now introducing Melatonin Pharma Nord, a high-quality medical drug that only contains pure melatonin without any unnecessary additives. The fast-release formula enables the melatonin content to deliver a swift and reliable effect.

Sleep problems like jet lag that are a result of disrupting your 24-hour clock can be most frustrating. Restore your rhythm with the natural compound melatonin.

Each tablet of Melatonin Pharma Nord contains 3 milligrams of high-quality, pharmaceutical-grade melatonin.

Available on prescription only.

Prescribing Information – Ireland

For full prescribing information refer to the Summary of Product Characteristics.

1. What Melatonin Pharma Nord is and what it is used for Melatonin Pharma Nord contains the active substance melatonin. Melatonin Pharma Nord can be used for treatment of jet-lag in adults. Jet-lag can be recognized by sleep disturbances, daytime tiredness, fatigue, mild mental impairment, irritability and digestive system disturbances experienced after flying.

How Melatonin Pharma Nord works Melatonin is a hormone produced by the body that synchronizes the body’s biological day-and-night rhythm. The biological rhythm can be disturbed by travelling across time zones. This is known as a jet-lag. The symptoms and their severity vary between individuals, but are generally worse and last longer the more time zones are crossed. Melatonin Pharma Nord can help restore the normal day-and-night rhythm and reduce the symptoms. You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before you take Melatonin Pharma Nord

Do not take Melatonin Pharma Nord if you are allergic to melatonin or any of the other ingredients of this medicine (listed in Section 6). Warnings and precautions

Talk to your doctor or pharmacist before taking Melatonin Pharma Nord if you have epilepsy. Melatonin may increase seizure frequency in patients with epilepsy if you have an autoimmune disease (where the body is ‘attacked’ by its own immune system)

• if you have diabetes or impaired glucose tolerance, as this medicine may increase the level of glucose in your blood if you suffer from significantly impaired liver function or kidney function if you smoke. Smoking may reduce the effect of Melatonin Pharma Nord as components of tobacco smoke can increase the breakdown of melatonin by the liver.

Children and adolescents

Do not give this medicine to children and adolescents between 0 and 18 years as its safety and efficacy are unknown.

Other medicines and Melatonin Pharma Nord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Fluvoxamine (used for the treatment of depression and obsessive-compulsive disorder), as fluvoxamine may increase the effect of melatonin. Psoralens (used for the treatment of skin disorders e.g. psoriasis), as psoralens may increase the effect of melatonin.

• Cimetidine (used for the treatment of stomach problems such as ulcers), as cimetidine may increase the effect of melatonin.

Estrogens (used in contraceptives or hormone replacement preparations), as estrogens may increase the effect of melatonin.

• Quinolones (used in the treatment of bacterial infections), as quinolones may increase the effect of melatonin.

Rifampicin (used in the treatment of bacterial infections), as rifampicin may decrease the effect of melatonin.

• Carbamazepine (used in the treatment of epilepsy), as carbamazepine may decrease the effect of melatonin.

Benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep, e.g. midazolam, temazepam, and zaleplon, zolpidem, zopiclone), as melatonin may enhance the sedative effect of such medicines, and may enhance certain side effects of zolpidem (morning sleepiness, nausea, confusion).

Melatonin Pharma Nord with food and alcohol

This medicine should not be taken with food (see Section 3).

As alcohol can impair sleep and potentially worsen certain symptoms of jet-lag (e.g. headache, morning fatigue, concentration) it is recommended that alcohol is not consumed while taking this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Melatonin Pharma Nord is not recommended if you are pregnant. Melatonin crosses the placenta and there is insufficient information on the risk this may pose to the unborn child. If you are a woman of childbearing potential you have to use contraception.

Breast-feeding

Melatonin Pharma Nord is not recommended if you are breast-feeding. Melatonin is excreted in human milk, and a risk to the breast-fed infant or child cannot be excluded.

Fertility

Melatonin Pharma Nord is not recommended in women and men planning to have a baby as there is insufficient information on the effects of melatonin on female and male fertility.

Driving and using machines

Melatonin Pharma Nord may cause drowsiness and may decrease alertness for several hours after intake. Therefore, this medicine should not be taken prior to driving or using machines.

3. How to take Melatonin Pharma Nord

Always take this medicine exactly as described in the spc or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults and elderly is 1 tablet daily for a maximum of 5 days. When the effect of Melatonin Pharma Nord is inadequate, 2 tablets can be taken simultaneously.

The first dose should be taken on arrival at destination at your usual bed-time. Intake on the following days should also be at your usual bed-time. Tablet(s) should not be taken before 20:00 hr or after 04:00 hr.

other liquid (e.g. milk, fruit juice). Food should not be consumed 2 hours before or 2 hours after intake of Melatonin Pharma Nord.

Melatonin Pharma Nord 3 mg may be taken for a maximum of 16 treatment periods per year.

If you take more Melatonin Pharma Nord than you should

If you have taken more Melatonin Pharma Nord than recommended and you do not feel well, please contact your doctor, hospital or pharmacy.

The most common symptoms of overdose are drowsiness, headache, dizziness, and nausea.

If you forget to take Melatonin Pharma Nord

If you forget to take a tablet(s) at bedtime and wake during the night you may take the forgotten dose but at no later than 04:00 hr.

Do not take a double dose to make up for a missed dose.

If you stop taking Melatonin Pharma Nord

If you stop taking Melatonin Pharma Nord, it will not have any harmful effects or withdrawal symptoms. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

If you experience any of the following serious side effects stop taking this medicine and contact your doctor immediately:

Uncommon side effects (may affect up to 1 in 100 people)

Chest pain.

Rare side effects (may affect up to 1 in 1.000 people)

• Reduced number of white blood cells in the blood.

• Reduced number of blood platelets, which increases the risk of bleeding or bruising. Disorientation.

Fainting.

Visual impairment, including blurred vision.

Feeling your heartbeat (‘pounding chest’).

Blood (red blood cells) in the urine.

Not known (frequency cannot be estimated from available data)

Severe allergic reaction resulting in swelling of the tongue or lining of the mouth.

Non-serious side effects

If you experience any of the following non-serious side effects contact your doctor or pharmacist:

Common side effects (may affect up to 1 in 10 people)

Headache.

Drowsiness.

Uncommon side effects (may affect up to 1 in 100 people) Irritability, nervousness, restlessness, abnormal dreams, anxiety.

• Dizziness. High blood pressure. Abdominal pain, upper abdominal pain, indigestion, mouth ulceration, dry mouth, nausea. Itching, rash, dry skin.

Excretion of glucose in the urine, excess protein in the urine.

• Feeling unwell.

• Weight increase.

Rare side effects (may affect up to 1 in 1,000 people)

High levels of certain fat molecules (triglycerides) in the blood.

Altered mood, aggression, increased sex drive.

• Memory impairment, restless legs syndrome, ‘pins and needles’ sensation.

• Watery eyes. Hot flushes. Vomiting, wind, excess saliva, bad breath, inflammation of the stomach lining. Nail disorder.

Arthritis, muscle spasms.

• Passing large volumes of urine.

• Prolonged erection that might be painful, inflammation of the prostate gland. Thirst.

Abnormal levels of electrolytes in the blood.

Not known (frequency cannot be estimated from available data)

• Hypersensitivity reactions.

• High blood glucose level.

• Flow of milk from the breasts (also in men).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. Reporting forms and information can be found at: https://www.hpra.ie/.

6. Contents of the pack and other information

What Melatonin Pharma Nord contains The active substance is melatonin.

Each tablet contains 3 mg melatonin.

The other ingredients are: magnesium stearate, colloid silica anhydrous, maltodextrin, microcrystalline cellulose, carmellose sodium. Film coating: hypromellose.

What Melatonin Pharma Nord looks like and contents of the pack

Round, biconvex, clear-coated, white to off-white tablet. Size 7.5 mm.

Blister pack containing 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer Pharma Nord ApS

Tinglykke 4-6

DK-6500 Vojens Denmark

Pharma Nord products, Melatonin Pharma Nord is manufactured with the main focus on bioavailability, safety, and documentation.

Crohn’s Disease: Presentation to Management

Inflammatory Bowel Disease (IBD) describes a group of conditions in which the intestines become inflamed. The two most common inflammatory bowel diseases are Crohn’s disease and ulcerative colitis. Another form of IBD is microscopic colitis. There is no official database which gives accurate figures, but it is thought that at least 40,000 people are living with IBD in Ireland. There were 5.9 new cases of Crohn’s disease in Ireland per 100,000 population in 2011 and 14.9 new cases of ulcerative colitis. The incidence of Crohn’s disease is higher than ulcerative colitis in children. Males and females are affected equally and patients can be diagnosed at any age, including babies and children. The peak age of incidence is between the ages of 15 and 35, with a second (smaller) peak from the 50s to 70s. IBD diagnosed in children can behave differently and can be treated differently to that diagnosed in adults.

Crohn’s Disease Latest Research

Efforts are underway to better understand if commonly used medications for Crohn’s and Colitis alter the risk of complications of COVID-19. Irish investigators from St. Vincent’s University Hospital are working as part of a global research study called SECURE-IBD (https://covidibd.org/) to understand how the disease impacts Crohn’s and Colitis patients. Information on over 1,000 patients with Crohn’s and Colitis who have been diagnosed with COVID-19 has already been analysed and the results to date provide some initial reassurance – with little evidence to show that patients with IBD are at greater risk of contracting COVID-19.

Professor Glen Doherty, Consultant Gastroenterologist at St. Vincent’s University Hospital said: “The initial results of this study are really promising as they show that people living with Crohn’s and Colitis are mostly not at greater risk of complications of COVID-19 and may not be as vulnerable a group as we initially feared.

“Crohn’s and Colitis are becoming much more common in our population. The number of new cases diagnosed each year has tripled in the last 10 years. It is estimated that currently 0.5% of the population suffer with Ulcerative Colitis (UC) and 0.3% of people with Crohn’s. This translates to 40,000 patients in Ireland living with these diseases but most don’t like to talk about it because of the embarrassing nature of the symptoms.” Doherty said “Continued research and on-going clinical trials are essential so we can find new treatments for the increasing number of people living with this disease.”

Crohn’s Disease Development

According to Theresa Lowry Lehnen, Clinical Nurse Specialist and Associate Lecturer Institute of Technology Carlow, Crohn’s disease (CD) is a chronic idiopathic inflammatory bowel disease characterized by transmural inflammation and lesions that can affect the entire gastrointestinal tract, but most commonly occurs at the terminal ileum and colon. The prevalence of CD has an incidence of 3 to 20 cases per 100,000. The exact pathogenesis of CD is unknown, although a number of genetic,

immune system and environmental factors have been shown to increase the risk of the illness and lead to the aberrant gut immune response characteristic of the disease. There is both direct and indirect evidence to suggest that genetics plays a role in the development of Crohn’s disease.

Theresa told Hospital Professional News, “Direct evidence is provided as 32 different specific genetic alterations have been identified which are more common in people with Crohn’s disease than in the population at large, and indirect evidence seen because Crohn’s disease appears to run in families. The immune system also becomes disrupted in Crohn’s disease and sends tumour necrosis factor (TNF) antibodies to kill all bacteria, regardless of whether they are friendly or not. TNF antibodies cause most of the inflammation associated with Crohn’s disease.”

One of the most notable risk factors for developing Crohn’s disease is smoking, aside from family history and ethnic background.

Theresa explains why saying, “Smokers are twice as likely to develop Crohn’s compared with non-smokers and those who smoke usually experience more severe symptoms compared with those with the condition who do not smoke. While there is no evidence that diet causes, or plays a role in Crohn’s disease, certain types of food and drink have been associated with worsening symptoms including milk, dairy products, alcohol, spicy, fatty and high-fibre foods. There is no single diet or eating plan that will work for everyone with Crohn’s disease and dietary recommendations must be tailored individually. Although flares are sometimes associated with stressful events, there is no evidence to prove that stress causes or contributes to Crohn’s disease.”

Interview with Theresa Lowry Lehnen (GPN, RNP, PhD) Clinical Nurse Specialist and Associate Lecturer Institute of Technology Carlow

There are 3 main phenotypes of CD: inflammatory, stricturing, and penetrating. Presenting symptoms are variable and some patients may have symptoms for years before the diagnosis of Crohn’s disease is made. Patients with inflammatory disease often present with abdominal pain and diarrhoea, and may develop more systemic symptoms including weight loss, low-grade fevers, and fatigue. Patients with stricturing disease may develop bowel obstructions while those with penetrating CD can develop fistula or abscesses. When an abscess is present, in addition to abdominal pain, patients can have systemic symptoms such as fever and chills and may also present with signs of acute peritonitis.

Heredity

Crohn's Disease

Environmental Factors

The Immune System

Diagnosis of Crohn’s Disease

Theresa notes that the diagnosis of Crohn’s disease can be quite difficult given that presenting symptoms can be insidious and nonspecific.

“Symptoms that require further investigation include weight loss, bloody diarrhoea, iron deficiency, and night-time awakenings,” she says. “Similarly, significant family history of IBD, unexplained elevations in the C - reactive protein level, sedimentation rates, or other acute phase reactants such as ferritin and platelets, or low B12 should prompt further investigation.

“There is no single test that can be used to confirm or disprove a diagnosis of Crohn’s disease. The diagnosis of CD is made on the basis of symptoms, endoscopic and radiologic findings. (Colonoscopy, Biopsy, SBE, CT, MRI, Wireless Capsule Endoscopy) Pathology can also be confirmatory.

“Other conditions can mimic symptoms of CD so it is important to rule out infection and other causes even when patients with known CD are having flare-ups. Patients with diarrhoea should be assessed for infection, IBD, and in certain cases coeliac disease. Other conditions that may present similar to CD include appendicitis, Behcet disease, and Ulcerative Colitis.”

Both Crohn’s Disease and Ulcerative Colitis (UC) are inflammatory bowel diseases (IBDs), but there are some key differences.

vulnerability to infection, cataracts, muscle cramps and stiffness, and vitamin D and calcium supplements will be required to help protect against the effects of osteoporosis. Due to increased vulnerability to infections, close contact with people who are known to have infections, particularly those with chickenpox, measles and shingles should be avoided.

Prednisolone is used in cases where budesonide proves ineffective. It has the same type of short and long-term side effects as budesonide, and has also been known to cause mental health problems in an estimated 5% of people.

Aminosalicylates

Sulfasalazine belongs to a group of medicines called aminosalicylates, known to reduce inflammation inside the colon. Sulfasalazine can be used as an alternative to steroids to treat mild cases of Crohn’s disease. Common side effects include headache, nausea, abdominal pain and diarrhoea.

Immunosuppressants

Immunosuppressants are used in maintenance therapy and in combination with steroids when a person has a relapse of symptoms. Two immunosuppressants widely used for treating Crohn’s disease are azathioprine and mercaptopurine.

however, most patients will eventually require surgery. Unfortunately surgery is not curative and patients still require ongoing therapy even after surgery for disease recurrence.

Surgery

Surgery is required when the symptoms of Crohn’s disease cannot be controlled using medication alone. During surgery, the inflamed section of the digestive system is removed and the remaining part is reattached. An estimated 80% of people with Crohn’s disease require surgery at some point in their life. Surgery does not cure Crohn’s disease, but it can provide long periods of remission, often lasting several years. A stoma may be required if the disease or inflammation is so severe that an immediate anastomosis is not safe. In some in¬stances, the stoma may be temporary and can be closed once the severe inflammation and infection is controlled. A colostomy is also required if the rectum is removed.

Over 40,000 people in Ireland are living with inflammatory bowel disease (IBD), most of whom are diagnosed between the ages of 15 and 30. Of these approximately 20,000 people suffer from colitis and Crohn’s Disease.

It is important not to confuse inflammatory bowel disease (IBD) like Crohn’s disease or ulcerative colitis with irritable bowel syndrome (IBS). IBS is a disorder that affects the muscle contractions of the bowel and is not characterized by intestinal inflammation, nor is it a chronic disease, she adds.

Treatments

Diagnosis of Crohn’s Disease

Common side effects of azathioprine include increased vulnerability to infection, bleeding and bruising. Less common side effects include headaches, shortness of breath, dizziness, nausea and vomiting.

There are 3 main phenotypes of CD: inflammatory, stricturing, and penetrating Presenting symptoms are variable and some patients may have symptoms for years before the diagnosis of Crohn’s disease is made Patients with inflammatory disease often present with abdominal pain and diarrhoea, and may develop more systemic symptoms including weight loss, lowgrade fevers, and fatigue. Patients with stricturing disease may develop bowel obstructions while those with penetrating CD can develop fistula or abscesses. When an abscess is present, in addition to abdominal pain, patients can have systemic symptoms such as fever and chills and may also present with signs of acute peritonitis.

While there are several medications available to treat Crohn’s disease, there is no cure. Here Theresa gives an overview of some of the more common treatments.

Theresa notes that most Irish patients are hospitalised within two years of diagnosis and more than half will eventually need surgery. “A report by the Irish Society for Colitis and Crohn’s Disease in 2015, showed that 49% of sufferers lost or had to leave a job because of their condition. The report also showed that Crohn’s alone cost the health service ¤185 million a year and that paediatric cases of IBD have increased three-fold in Ireland since 2003,” she says.

Theresa notes that the diagnosis of Crohn’s disease can be quite difficult given that presenting symptoms can be insidious and nonspecific.

Steroids

Mercaptopurine originally developed to treat leukaemia has since proved effective in the treatment of Crohn’s disease. Given in tablet form, its side effects are not as severe as those associated with other forms of chemotherapy treatment. Common side effects include nausea and vomiting while less common side effects include loss of appetite, fatigue, and breathlessness and weakness caused by anaemia. Effective contraception if sexually active is important while taking mercaptopurine, as it temporarily affects both ova and sperm and can increase the risk of birth defects.

“Symptoms that require further investigation include weight loss, bloody diarrhoea, iron deficiency, and night-time awakenings,” she says. “Similarly, significant family history of IBD, unexplained elevations in the C - reactive protein level, sedimentation rates, or other acute phase reactants such as ferritin and platelets, or low B12 should prompt further investigation.

Steroids are used to induce remission but are not an effective maintenance agent. Steroids are usually only used to treat the active disease because their long-term use is associated with a range of adverse side effects. Budesonide and prednisolone are two steroids that are often used to treat Crohn’s disease.

Biological Therapies

“There is no single test that can be used to confirm or disprove a diagnosis of Crohn's disease. The diagnosis of CD is made on the basis of symptoms, endoscopic and radiologic findings. (Colonoscopy, Biopsy, SBE, CT, MRI, Wireless Capsule Endoscopy) Pathology can also be confirmatory.

Budesonide is usually the first choice of steroid prescribed to help control the symptoms of Crohn’s disease. Taken on a short-term basis of less than 12 weeks budesonide may cause acne, oedema of the face, hands, arms, feet and legs, mood changes, insomnia and indigestion. If taken for more than 12 weeks, budesonide may cause osteoporosis, increased

Both Crohn’s Disease and Ulcerative Colitis (UC) are inflammatory bowel diseases (IBDs), but there are some key differences.

Crohn’s disease

Inflammation may develop anywhere in the GI tract from the mouth to the anus

Most commonly occurs at the end of the small intestine

May appear in patches

May extend through entire thickness of bowel wall

About 67% of people in remission will have at least 1 relapse over the next 5 years

Biological therapies are a new type of medication created using naturally occurring biological substances, such as antibodies and enzymes. Two main biological therapies are infliximab and adalimumab. Infliximab is usually only recommended in severe cases of Crohn’s disease that have not responded to steroid and immunosuppressant treatments, and where the person is unsuitable for surgery. The goal of medication management is to control the inflammation and induce a clinical remission with pharmacological therapy,

“A survey of service providers treating patients with IBD, conducted by the Irish Society of Gastroenterology (ISG), found that the lack of dedicated specialist nurses in Ireland was the greatest barrier to delivering patient care. The Irish Society for Colitis and Crohn’s Disease campaign for the 2018 World IBD Day (#DoubleUp) proved very successful. The campaign called for the number of specialist Inflammatory Bowel Disease (IBD) nurses to be increased from 14 to at least 28, to bring Ireland in line with international best practice. As of May 2019 the number of specialist nurses in Ireland has increased to 26.

“Other conditions can mimic symptoms of CD so it is important to rule out infection and other causes even when patients with known CD are having flare-ups. Patients with diarrhoea should be assessed for infection, IBD, and in certain cases coeliac disease. Other conditions that may present similar to CD include appendicitis, Behcet disease, and Ulcerative Colitis.”

Ulcerative Colitis

Limited to the large intestine (colon and rectum)

Occurs in the rectum and colon, involving a part or the entire colon

Appears in a continuous pattern

Inflammation occurs in innermost lining of the intestine

About 30% of people in remission will experience a relapse in the next year

It is important not to confuse inflammatory bowel disease (IBD) like Crohn’s disease or ulcerative colitis with irritable bowel syndrome (IBS). IBS is a disorder that affects the muscle contractions of the bowel and is not characterized by intestinal inflammation, nor is it a chronic disease, she adds.

“A holistic person-centred approach is required in the management of patients with Crohn’s Disease, who face a lifelong condition that can be emotionally and physically debilitating. The role of the clinician is to provide ongoing assessment, management, support and education. Key roles are to establish a therapeutic relationship with the patient, assess their understanding of the condition, establish goals and expectations for successful management of their condition and evaluate their physical, emotional, and psychological well-being. “Common concerns for patients are adherence to their therapeutic regimen, pain and discomfort. Many patients experience anxiety, anger, frustration, stress and depression. Assessment, monitoring, audit and evaluation for disease activity, progression, and effects of the therapeutic regime on a patient with Crohn’s disease is a continuous process. By implementing person-centred care, monitoring and evaluating symptoms, outcomes and responses to therapy, clinicians play a pivotal role in managing the illness and improving the patient’s quality of life.”

References available on request

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CPD: Emergency Contraception

CPD

60 Second Summary

Emergency contraception is a very important service that pharmacies provide. It is imperative that pharmacists are well equipped with the knowledge and skills to accurately provide the service. This includes having all the relevant information to support women seeking the service to make informed decisions and to address any concerns they may have. It is also important to be able to address any misconceptions and myths surrounding emergency contraception and to hold consultations of a high standard. This CPD module will explain the different Emergency Hormonal Contraception (EHC) options available in pharmacies, their mode of action and how best to take them. It also highlights the most common myths and the facts regarding them. This module also contains information on how best to approach a consultation for EHC to ensure a non-prejudice and open environment for discussion. There is also additional information and advice to give women availing of the service.

A woman’s reproductive years are characterised by monthly changes in the rates of secretion of the female hormones required for reproduction. This rhythmic pattern is the normal menstrual cycle.

The two main functions of the menstrual cycle are:

• to release an egg, and

• to prepare the endometrium for implantation if the egg is fertilised.

In the absence of fertilisation, the ovum and the endometrial lining are discarded in menstruation. Hormone release during the monthly cycle is regulated by a complex neuroendocrine feedback loop.

The ovarian/menstrual cycle is regulated by the gonadotrophic

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?

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

CPD

-

Common Myths with Emergency Contraception: Consultation Advice for Pharmacists

hormones; Luteinising Hormone (LH) and Follicle Stimulating Hormone (FSH). Below is a brief overview of each step.

1234

Step 1: At the beginning of each cycle (onset of menstruation) the levels of FSH increase. This causes the development of follicles within the ovary, i.e. the follicular phase. The result is maturation of the ovum and stimulation of the ovary to produce oestrogen, specifically oestradiol.

Step 2: The increased levels of oestrogen in turn trigger the release of LH from the anterior pituitary. LH is responsible for the final maturation of the follicle and release of the egg at ovulation (approximately day 14 of the cycle).

Step 3: In the absence of fertilisation, the high concentration of LH causes the empty follicle to develop into the corpus luteum which secretes oestrogen and progesterone over the next 11 to 12 days (luteal phase).

Step 4: On approximately day 27 of the cycle, the levels of oestrogen and progesterone fall and menstruation commences on day 28.

Emergency Contraception

Emergency contraception (also known as ‘postcoital contraception’ or ‘the morning after pill’) provides women with a way to prevent an unintended pregnancy, following unprotected sexual intercourse or contraception failure.

1234

Step 1

At the beginning of each cycle (onset of menstruation) the levels of FSH increase. This causes the development of follicles within the ovary, i.e. the follicular phase.

The result is maturation of the ovum and stimulation of the ovary to produce oestrogen, specifically oestradiol.

42 CPD: Emergency Contraception

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.

Emergency contraceptive pills prevent pregnancy by delaying ovulation and they do not induce an abortion, as the egg is not there to be fertilised.

Latest Research

In a survey* carried out among 18-34 year old women by morning after pill brand ellaOne®, over half (54%) said they have had unprotected sex in the past year where either contraception failed or none was used and they were

Knowledge of How The Morning After Pill Works

morning after pill works?

not trying to become pregnant. Of those women, only 26% used emergency contraception.

For the 74% majority who didn’t take the morning after pill, 1 in 3 (32%) said they ‘decided to risk it and hope they didn’t become pregnant’. Of more concern, almost a quarter of 18-24 year old women surveyed said they were too embarrassed to go to a pharmacist to ask for emergency contraception and 11% of the same group said they didn’t want to tell a pharmacist they had unprotected sex during a pandemic.

According to this research, only 3 in 10 (28%) of females aged 18-34 correctly know that the morning after pill works by delaying ovulation. Just over 7 in 10 (72%) of females aged 18-34 are unaware of how the morning after pill actually works.

In pharmacies, the types of emergency contraction available are oral pills levonorgestrel and ellaOne®. The Copper Coil (Post Coital IUD) is another form of emergency contraception which can be inserted by a specially trained doctor or Family Planning Clinics.

ellaOne®

ellaOne® (a single dose of ulipristal acetate 30mg) is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. If vomiting occurs within three hours of ellaOne® intake, then another tablet should be

taken. There is very limited trial data on its use in females aged under 18 years. However, the SPC for ellaOne® states: ‘ellaOne® is suitable for any woman of childbearing age, including adolescents. No differences in safety or efficacy have been shown [in adolescents] compared to adult women aged 18 and older. Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator. According to the manufacturer’s literature, the main mechanism of action is inhibition or delay of ovulation. The Faculty of Sexual and Reproductive Healthcare (FSRH) states that ulipristal acetate delays ovulation for at least 5 days, until sperm from the unprotected sexual intercourse are no longer viable. Advice for patients who have taken ellaOne®:

• Wait at least 5 days before taking your next contraceptive pill, applying a new patch or inserting a new ring

• Use additional contraception, such as condoms, until you restart your contraception and for an additional:

Time limit for use after unprotected sex: 120 hours (5 days)

Effectiveness: 99.5% effective. Should be taken as soon as possible. ellaOne® may be less effective for those on some hormonal contraceptives, or if they have taken other emergency contraceptive pills in the

same cycle. Contraceptive action of combined hormonal contraceptives and progestogenonly contraception may be reduced. Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended.

Available: ellaOne® is available directly from pharmacists (chemist) without prescription.

In 2017 the HSE made the availability of Emergency Hormonal Contraception (EHS) free of charge to female medical card holders, directly from pharmacists without a GP prescription following a pharmacist delivered consultation. Works by: Delaying ovulation before the peak of ovulation producing hormones.

Side-effects:

There are no serious or longterm side effects from taking the emergency contraceptive pill. But it can cause:

• changes to your next period – it can be earlier, later, or more painful than usual

• feeling or being sick – 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

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 your lower tummy – in rare cases, a fertilised egg may have implanted outside the womb (ectopic pregnancy)

When providing a consultation to patients it is best not to assume anything about the patient; they may not be sexually active but may still want advice and also they may not already know the facts. Being aware of this and that you may have to go back to basics and giving information in stages ensures the patient had ample time to ask questions and for you to clarify any areas of misunderstanding.

On page 43 is a table of common myths and misconceptions about emergency contraception.

Levonorgestrel:

One tablet should be taken as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse. If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately.

Levonorgestrel 1.5mg tablets can be used at any time during the menstrual cycle unless menstrual bleeding is overdue.

After using emergency contraception, it is recommended to use a local barrier method (e.g. condom, diaphragm, spermicide, cervical cap) until the next menstrual period starts. The use of levonorgestrel does not contraindicate the continuation of regular hormonal contraception.

Special warning from the manufacturer is as follows:

Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method.

Emergency contraceptiondoes not prevent a pregnancy in every instance. If there is uncertainty about the timing of the unprotected intercourse or if the woman has had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, conception may have occurred. Treatment with levonorgestrel following the second act of intercourse may therefore be ineffective in preventing pregnancy. If menstrual periods are delayed by more than 5 days or abnormal bleeding occurs at

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

Myth/ misconception

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

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

Latest Pharmacy Offerings

the expected date of menstrual periods or pregnancy is suspected for any other reason, pregnancy should be excluded.

Fact

Emergency contraception should be taken as soon as possible and its effectiveness can decrease if left too long, 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 or more than once per menstrual cycle

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

Three Day Pill (Prevenelle or Norlevo)

have a consultation prior to her coming into the pharmacy, if required.

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.

Levonorgestrel’s exact mode of action is unknown. The manufacturer states that “levonorgestrel is thought to work mainly by preventing ovulation and fertilisation, if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. It may also cause endometrial changes that discourage implantation. Levonelle® 1500 is not effective once the process of implantation has begun.”

Time limit for use after unprotected sex: 72 hours (3 days)

Access to the morning after pill is easy and convenient with an online click and collect service for ellaOne available nationwide through four pharmacy groups – McCabes, Hickey’s, Life Pharmacies and Allcare Pharmacies. Available without a prescription, the service means women can assess their suitability for the morning after pill online, arrange a telephone consultation with the pharmacist if that’s their preference, and collect their purchase as soon as one hour after ordering. The morning after pill is free for women who hold a medical card.

EHC Consultations:

Effectiveness: Results from the randomised, double-blind clinical studies conducted in 1998, 2001and 2010 showed that a 1500 microgram levonorgestrel (taken within 72 hours of unprotected sex) prevented 85%, 84%, 97% of expected pregnancies respectively. It is less effective on day two and day three. It will be less effective if you have already used the five day contraceptive pill in the same cycle.

The patient should be advised to:

• Take their next contraceptive pill, apply a new patch or insert a new ring within 12 hours of taking the emergency pill

It is important to be respectful and maintain an environment that is open and free of judgement where the woman seeking EHC does not feel stigmatised and embarrassed or ashamed to be seeking EHC.

Available: Norlevo is available directly from pharmacists. Prevenelle and Norlevo are available on prescription from a doctor (including out of hours co–ops) or Family Planning Clinics.

Access to the morning after pill is easy and convenient with an online click and collect service for ellaOne® available nationwide through four pharmacy groups – McCabes, Hickey’s, Life Pharmacies and Allcare Pharmacies. Available without a prescription, the service means women can assess their suitability for the morning after pill online, arrange a telephone consultation with the pharmacist if that’s their preference, and collect their purchase as soon as one hour after ordering. The morning after pill is free for women who hold a medical card.

EHC Consultations:

Therefore, all staff must be trained to ensure this is maintained throughout the consultation process.

• continue taking your regular contraceptive pill as normal

• Use additional contraception, such as condoms, for:

The use of the pharmacy’s consultation room is imperative so that confidentiality is maintained, and the woman feels safe and encouraged to ask questions and gather as much information to be properly informed to make an informed decision.

7 days if you use the patch, ring, combined pill (except Qlaira), implant or injection

9 days for the combined pill Qlaira

2 days if you use the progestogen-only pill

A summary of levonorgestrel

Works by: Delaying ovulation in the first 14 days of your cycle.

Latest Pharmacy Offerings

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

It is important to be respectful and maintain an environment that is open and free of judgement where the woman seeking EHC does not feel stigmatised and embarrassed or ashamed to be seeking EHC.

Therefore, all staff must be trained to ensure this is maintained throughout the consultation process.

The use of the pharmacy’s consultation room is imperative so that confidentiality is maintained, and the woman feels safe and encouraged to ask questions and

CPD: Emergency Contraception

hesitation or barriers that may be in place.

It is also important to be vigilant and aware that a patient seeking emergency contraception may have been sexually assaulted and not given consent to sexual intercourse. In this case it is not advised to use the word ‘sex’ as what has happened is ‘rape’.

The advice for those concerned about additional risks such as STIs is that they should make an appointment to get tested at a free public STI screening service all around Ireland.

are missed, and unprotected intercourse has occurred.

gather as much information to be properly informed to make an informed decision.

Inform the woman that seeking EHC is positive that they are proactive with regards to their sexual health. The need for EHC does not mean that they are reckless or irresponsible. Compassion is imperative while providing the service.

Allowing sufficient time to gather the required information and to give advice on how to correctly take the contraception and sideeffects to be aware of. Being as transparent as possible and open to discussion will greatly help the consultation and to overcome any

Case Study: The Embarrassed Customer

Patient A visited the pharmacy recently and after browsing the shelves it became apparent she was waiting for the customer queue to decrease and looking for the pharmacist’s attention. It was clear that whatever issue she wished to consult on, was causing some embarrassment. How do we deal with these patients when it comes to emergency contraception advice?

It is important that all pharmacy staff, as well as the pharmacist themselves, are making the best use of the various products on offer, and services and advice available to help support women when choosing emergency contraception.

No Judgement: In order to be able to conduct an efficient

The legal age of sexual consent in Ireland is 17 years and some women who may be below this age may find accessing EHC in pharmacies very daunting and are worried that they may get into trouble with Gardaí or that the pharmacist may tell their parents. If you decide not to provide EHC to a younger woman then provide them with other options such as a doctor or clinic. The most important thing is that the young woman does not feel discouraged in continuing to seek emergency contraception.

Referral may also be needed if the woman is seeking EHC outside the recommended time frame or if there is a possibility that the woman may already be pregnant. If the patient takes liver-enzyme inducers e.g. Rifampacin, Carbamazepine it would be advised that they go to see a doctor as the metabolism of both levonorgestrel and ellaOne is enhanced by liver enzyme inducers. Taking EHC, even multiple times, will not affect fertility and it will not prevent pregnancy in the future.

consultation, you must remain friendly and above all, nonjudgemental in approach. Current guidance suggests that pharmacists be sensitive in the way they communicate with patients regarding emergency contraception and do not imply or express disapproval.

Sex and relationship expert Dr Caroline West says “We can see the sense of discomfort young women feel about telling the pharmacist they have had unprotected sex. This feeling can be so powerful that it can prevent women looking after their health and asking for emergency contraception. It’s worth reminding women that choosing to put themselves and their bodies first is a great choice and something to feel positive about.

If a woman has used her regular contraception incorrectly, it is important to gather all the relevant information to make an informed decision on whether she needs emergency contraception. Information on this can be found in the BNF, an example of this is as follows:

Regarding a combined hormonal contraceptive. The BNF12 states that “if a woman misses 2 or more pills (especially from the first 7 in a packet), she may not be protected. She should take an active pill as soon as she remembers and then resume normal pill-taking”.

Regarding additional precautions: The BNF12 states that she must either abstain from sex or use an additional method of contraception such as a condom for the next 7 days. If these 7 days run beyond the end of the packet, the next packet should be started at once, omitting the pill-free interval.

Regarding emergency contraception: The BNF12 states that emergency contraception is recommended if 2 or more combined contraceptive tablets

“This is about making positive decisions easier and hopefully minimising the impact that embarrassment can have on women’s health.”

Signposting: Reminding your customers that there is a discreet and confidential consultation area within the pharmacy is essential. For those who are not aware, they may leave if the pharmacy is particularly busy without seeking the help they need. Display posters advertising your private contraception consultations. Through appropriate sign posting you can also offer additional support for victims of sexual assault/rape and for those considering longer term contraception methods.

Be Tactful & Sensitive: Creating a welcoming environment is essential to providing good community pharmacy services.

More awareness needs to be made regarding the availability of EHC in pharmacies and whilst campaigns run by the IPU with IFPA.IE (see below) have helped in recent times, you as a pharmacist can train your team to encourage women to seek the service and to not be embarrassed. Posters in the pharmacy highlighting the service can help increase awareness and being well informed to help provide women with any questions or concerns they may help is vital.

References are available on request

*Research carried out among 2000 18-34 women living in Ireland in March 2021 by Empathy Research on behalf of ellaOne®

5 Questions

Q1) When is emergency contraception indicated for?

Q2) What emergency contraception options are available in pharmacies?

Q3) Are there any side-effects with taking emergency contraception?

Q4: What are some of the common misconceptions and myths regarding emergency contraception?

Q5: What additional advice can be given as part of the EHC consultation process?

In order to get an insight into the reason as to the need for emergency contraception, be tactful in your approach. Put yourself in their shoes. Due to their embarrassment they may not want to voice concerns about their overall sexual health but simply want help so the importance of maintaining privacy and respecting the customer is paramount.

Fundamentally, each customer should be considered on a case-by-case basis as every individual is different and there is no ‘one-size-fits-all’ approach when it comes to contraception. It is also a good idea to keep up to date with any training and contraception news in order to anticipate any queries about a specific contraceptive that has recently been launched or attracted media attention.

It‘s her morning after

Be her support and ensure she’s making an informed choice.

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. RETAIL PRICE: ellaOne 30 mg single film-coated tablet blister pack; € 35. MARKETING AUTHORISATION HOLDER: Laboratoire HRA Pharma, 15, rue Béranger, F-75003 Paris, France. Marketed in Ireland by: HRA Pharma UK & Ireland Limited, Haines House, 21 John Street, Bloomsbury, London, WC1N 2BF MARKETING AUTHORISATION NUMBER(S): EU/1/09/522/003. LEGAL CATEGORY: Medicinal product not subject to medical prescription. DATE OF LAST

Improves

the Control and Prevention of

Reduces

9/10 patients did not require antibiotics with Utipro® Plus*

Significantly reduces recurring

Celebrating OTC Excellence and Innovation

The OTC pharmacy market in Ireland continues to thrive. An ageing population and the increased prevalence of diseases has supported an expansion in the OTC industry markets. There have been challenges, especially more recently with the advent of the Covid-19 pandemic but there have also been many opportunities for growth and innovation.

Consumer interest in preventative healthcare continues to deepen, reflected in strong growth recently in the demand for vitamins and dietary supplements. Today’s consumer health landscape focuses firmly on that of self-care as more people become attuned to their own wellbeing needs.

Pharmacies are the leading distribution channel for consumer health, the most turned to and trusted source of advice and information. The pandemic may have accelerated the trend for e-commerce but pharmacy remains at the heart of the community. It is therefore vital OTC companies work hand-in-hand with the profession with regards to product education, training and marketing.

The OTC & Retail Pharmacy Product Awards are the only industry awards that specifically recognises and rewards the companies and their products within the OTC market, acting as a celebration and showcase of product innovation, marketing and value to its customer.

These Awards are reviewed by an independent panel comprised of over 40 judges from across the community pharmacy sector, representing both multiple and independent pharmacies, buying groups, wholesalers and industry. Once again, the quantity and quality of the submissions surpassed previous years and across many categories it was a tough call.

The categories this year included Best Baby Skincare and Best Baby & Children’s Supplement to Best Marketing and Best Launch of the Year.

Originally launched in 2008, these Awards are designed to recognise product development and innovation in the pharmacy sector, applaud the investment by these companies, both large and small, into product development, training, marketing initiatives and promotional campaigns. The winners across our categories were contacted by the IPN team with the news and feedback. Over the following pages we feature all the winners and details on product selection from members of the judging panel.

Best Cough, Cold and Flu Product

“A product that completely sells itself. Tried and tested, and proven effective that customers love.” This is how one of the judges described Bronchostop, winner of the Best Cough, Cold and Flu Product 2022. Bronchostop is 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. The unique combination of ingredients in Bronchostop is traditionally used for the relief of any cough such as chesty coughs and dry, tickly, irritating coughs and phlegm.

The judges added, “Bronchostop is a great addition to the cough, cold and flu market as it has the unique selling point of being effective in the treatment of dry and chesty coughs. It is also alcohol free, non-drowsy and available in a pastille .The company have invested greatly in advertising and they are prompt to react when advertising material is requested.”

“This unique product has been a great option to recommend in the pharmacy. The syrup and pastille formulations offer a good variety and are both very popular. Brand loyalty and awareness and the marketing materials/support received are all very strong”

Judges comments

of Quitting Smoking

*Provides significant improvement in quit rate vs patch alone. To verify contact: verify@perrigo.com Lindson N et al. 2019 Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Library. NiQuitin CLEAR 24 hrs transdermal patches are indicated for the relief of nicotine withdrawal symptoms including cravings as an aid to smoking cessation. Indicated in adults and adolescents aged 12 years and over. NiQuitin patches should be applied once a day, at the same time each day and preferably soon after waking and worn continuously for 24 hours. Apply a patch to non-hairy clean dry skin surface, a new skin site should be used every day. Therapy should usually begin with NiQuitin 21 mg/24 hrs and reduced according to the following dosing schedule: Step1: NiQuitin Clear 21 mg/24 hrs transdermal patches first 6 weeks. Step 2: NiQuitin Clear 14 mg/24 hrs transdermal patches next 2 weeks. Step 3: NiQuitin Clear 7 mg/24 hrs transdermal patches last 2 weeks. Light smokers (less than 10 cigarettes per day) are recommended to start at Step 2 (14 mg) for 6 weeks and decrease the dose to NiQuitin 7 mg/24 hrs for the final 2 weeks. In some instances (e.g. heavy smokers, those who have relapsed after NRT, or when one NRT product is not enough to control cravings), NiQuitin patches may be used in combination with a nicotine oral format (refer to the package leaflet for dosing guidance). Contraindications: Non-smokers, hypersensitivity, children under 12 years and occasional smokers. Precaution: Supervise use if hospitalised for MI, severe dysrhythmia or CVA, if haemodynamically unstable. Use with caution in patients with active oesophagitis, oral and pharyngeal inflammation, gastritis, peptic ulcers, GI disturbances, susceptible to angioedema, urticaria, renal/hepatic impairment, hyperthyroidism, diabetes, phaeochromocytoma, seizures & epilepsy. Discontinue if severe persistent skin rash. Pregnancy and lactation: Oral formats preferable to patches unless nauseous. Remove patches at bedtime. Side effects: Sleep disorders, abnormal dreams, insomnia, headache, dizziness, nausea, vomiting, application site reactions, nervousness, palpitations, dyspnoea, pharyngitis, cough, dyspepsia, upper abdominal pain, diarrhoea, constipation, dry mouth, sweating, localised pain, urticaria, hypersensitivity, tremor, nervousness, palpitations, tachycardia, contact & allergic dermatitis, photosensitivity, arthralgia, myalgia, asthenia, malaise, influenza-type illness, fatigue, chest or limb pain, pain, seizures and anaphylaxis. Legal classification: GSL: PA 1186/18/4, PA 1186/18/5 & PA 1186/18/6. MAH: Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland. https://www.medicines.ie/medicines/niquitin-clear-7-mg-24-hours-transdermal-patch-33085/patient-info https://www.medicines.ie/medicines/niquitin- clear-14-mg-24-hours-transdermal-patch-33083/patient-info https://www.medicines.ie/medicines/niquitin-clear-21-mg-24-hours-transdermal-patch-33084/patient-info NiQuitin Mini 1.5mg/4mg Mint Lozenges are used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms and cravings. Indicated in adults and adolescents aged 12 years and over. NiQuitin Mini 1.5 mg are suitable for those who smoke who smoke 20 cigarettes or less a day. NiQuitin Mini 4 mg are suitable for smokers who smoke more than 20 cigarettes a day. Place a lozenge in the mouth whenever there is an urge to smoke, allow to dissolve completely. Do not chew or swallow whole. In heavy smokers, those who have relapsed after NRT, or when one NRT is not enough to control cravings, NiQuitin Minis may be used in combination with NiQuitin patches (refer to the package leaflet for dosing guidance). Abrupt cessation: Use a lozenge whenever there is an urge to smoke, maximum of 15 lozenges a day. Continue for up to 6 weeks, then gradually reduce lozenge use. Gradual cessation Use lozenges whenever there is an urge to smoke in order to reduce the number of cigarettes smoked for up to 6 weeks, followed by abrupt cessation. Adolescents (12-17 years): only with advice from a healthcare professional. Should not quit with a combination NRT regimen. Contraindications: hypersensitivity to nicotine or any of the excipients, children under the age of 12 years and non-smokers. Precaution: Supervised use in dependent smokers with a recent myocardial infarction, unstable or worsening angina pectoris including Prinzmetal’s angina, severe cardiac arrhythmias, uncontrolled hypertensions or recent cerebrovascular accident. Use with caution in those with; stable cardiovascular diseases, diabetes mellitus, susceptibility to angioedema & urticaria, renal/hepatic impairment, phaeochromocytoma &uncontrolled hyperthyroidism, GI disease & seizures. Side effects: Nausea, mouth/throat and tongue irritation, irritability, anxiety, sleep disorders, dizziness, headaches, cough, sore throat, vomiting, diarrhoea, GI and oral discomfort, flatulence, hiccups, heartburn, dyspepsia, dry mouth, constipation, ulcerative stomatitis, pharyngitis, nervousness, depression, palpitations, heart rate increased, dyspnoea, rash, angioedema, pruritus, erythema, hyperhidrosis, fatigue, malaise chest pain, anaphylactic reactions, hypersensitivity, tremor, dysgeusia, paresthesia mouth, seizures & epilepsy, dysphagia, eructation, salivary hypersecretion, influenza like illness. Legal classification: GSL: PA 1186/18/11 & PA 1186/18/12 MAH: Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland. https://www.medicines.ie/medicines/niquitin-mini-1-5mg-mint-lozenges-33090/smpc https://www.medicines.ie/medicines/niquitin-mini-4mg-mint-lozenges-33091/smpc

“Since I quit smoking, I enjoy a healthier me”

Samantha

Best Natural Product

A.Vogel Menoforce Sage Tablets won the Best Natural Product for 2022.

This product is a traditional herbal medicinal product used for the relief of menopausal hot flushes and excessive perspiration exclusively based on longstanding use. Sage works to rebalance sweat regulation and therefore resolve menopausal sweats and flushes without any hormonal activity.

The judges stated that with ‘clear clinical evidence behind this well-established product, there is strong customer loyalty to the brand. Women with menopausal symptoms often present to the pharmacy with symptoms such as hot flushes and there are limited products available with such strong clinical backing in this area. The fact it doesn’t interact with HRT is a huge consideration and with continued education to HCPs and marketing, I see huge potential for this product.”

Judges comments

“A well-known brand with a great selling point. Tried and tested, fantastic brand support. High in value to customers.”

Best Immunity Product

Kelkin Zinc & Vitamin C Effervescent scooped the Best Immunity Product. One of the judges commented as to how, when combined with clinical information learned throughout the pandemic, it delivers to pharmacy an ‘indispensable product.’

Kelkin great tasting food & supplements have helped to bring joy and energy to generations of families for over 40 years. With a story that began when husband and wife team Ken and Liz Kinsella, set out on a journey to make wholesome food available for everyone to enjoy, their passion for healthy living continues to inspire the team behind Kelkin to bring delicious food & supplements that fuels an appetite for life.

Kelkin Effervescent Zinc & Vitamin C provides 1,000mg Vitamin C and 15mg zinc in one convenient effervescent tablet.

Judges comments

“A really great product with two fantastic components –Zinc and Vitamin C, especially during the Pandemic. Very handy packaging, you can throw it in your handbag and have it on the go. I like the Irish husband and wife roots and great value for money product getting more than your NRVs, for each component”

Best Irish Pharmacy Product

With a range of unique selling points that keeps customers buying time and time again, Revive Active won the category for Best Irish Pharmacy Brand Product, with one of the judges commenting, “It is suitable for vegetarians, vegans, diabetics and is gluten free which is great as the market can often forget about these specific dietary requirements when creating products. Overall, one of the best products marketed to all ages.”

Revive Active is an award-winning super supplement with 26 active ingredients working together, helping put back what life takes out. This Irish super supplement is delivered in powdered format and contains a comprehensive combination of vitamins, minerals and amino acids in one convenient daily powdered sachet.

Revive Active is designed for active people balancing work, home and family life while maintaining a healthy immune system, heart health and energy.

Judges comments

“A gold-standard product! This is our top recommended product with incredible feedback given by those who take it.”

THREE WINS FOR IRISH SUPER SUPPLEMENT R ANGE

Judges commented that...

A gold-standard product! This is our top recommended product with incredible feedback given by those who take it. The brand provides fantastic support to pharmacies including regular in-depth training.

Judges commented that...

The formula is unique in that it contains all the ingredients needed to obtain and maintain healthier hair, skin and nails. It's also more a ordable as customers only have to buy one product rather than all the individual ingredients.

Judges commented that...

Attractively packaged, very well-marketed product, well-targeted advertising campaigns and sought after by young customers in the pharmacy. Reputable brand that I would not hesitate in recommending as being of very good quality.

Best Baby and Children Supplement

BabyVitD3 Pump by Shield Health won the Best Baby and Children’s Supplement Product Award for 2022.

BabyVitD3 is an Irish brand which has been on the market for over 10 years. It was one of the first Baby Vitamin D brands to come to the market from Shield Health. BabyVitD3 Pump are pure Vitamin D in the Cholecalciferol form. BabyVitD3 has no preservatives, no parabens no artificial colours, no flavourings, no peanut additives, no sugars or lactose and no gluten.

“The two unique selling points of this product is that the pump makes this product an allround winner you can use it for multiple children and also as part of the companies package, they send emails out to parents reminding them of Vitamin D towards the end of their pregnancy so they can be prepared for the new-borns arrival. Essential for every baby in Ireland,” commented the judges.

Judges comments

“BabyVitD3 is still the most popular in its category in our pharmacy. The pump is unique and preferred option for convenience of use and administration”

Best Mens Product

A highly anticipated launch last year, Viagra Connect has won the Best Men’s Product at the 2022 OTC & Retail Pharmacy Product Awards.

Viagra Connect is the first over-the counter treatment for erectile dysfunction (ED) for men age 18 years and older to be launched in the Republic of Ireland. A very successful focused consumer campaign, based on research carried out by Viatris with Irish men where men indicated they were embarrassed to discuss ED but welcomed the idea of an OTC treatment being available in pharmacies, included TV, radio, digital and the Public Relations campaign. Commented one of the judges, “Outstanding performer since becoming OTC – this product is widely recognised and support from Viatris is best in its class. Brand investment and in-store support superb. Definite winner of this category.”

Judges comments

“As a Pharmacist, I have no problem giving full marks to this product. The huge investment behind the product is extremely noticeable and they have been highly supportive to Pharmacists in terms of training and additional material for patients. I think it was a great development and brings men into the Pharmacy who may be too embarrassed to talk to their GP. While they are in store, they tend to ask about different ailments that they need advice on. Well done Viatris”

Best Eye Care Product

Best Eye Care Product for 2022 was awarded to HYLO-FORTE® with the judges listing it as an ‘excellent product with very strong medical recommendations. Brand highly regarded and very strong customer loyalty. A definite winner of this category,” they added.

HYLO-FORTE® is an eye-drop that provides intense lubrication and long-lasting relief from symptoms of dry eye disease. HYLO-FORTE® contains 0.2% sodium hyaluronate (SH) and provides patients with a preservative free & phosphate free formulation that is gentle on sensitive eyes.

It is contact lens compatible making it convenient for patients and remains sterile for up to 6 months once opened. It is suitable for adults and children of all ages and can be used during pregnancy and breastfeeding.

“It’s full marks from me on this product. It is my goto recommendation to the increasing number of patients presenting to the Pharmacy with dry eye complaints. The fact it is preservative-free, multidose and suitable to contact lens users, it’s no wonder that HYLO-FORTE is the market leader and in my opinion, will continue to strive in this field.”

Judges comments

WINNER OF BEST EYE CARE PRODUCT

Long lasting relief from tired, dry, sore, red eyes

100% Preservative Free Contact lens compatible

Can be used for up to 6 months from opening

Use as part of the 3-step Heat Cleanse Hydrate Dry Eye regimen

Sodium Hyaluronate

0.2%

To view our complete dry eye management range visit:  www.scopeeyecare.com or Freephone: 1800 816 005

Best Womens Product

Cleanmarine® MenoMin® have won the 2022 OTC & Retail Pharmacy Product Award within the Best Women’s Product category.

This Irish Brand offers a unique all-in-one Omega 3, Phytonutrient and Vitamin blend, formulated specifically to give extra nutritional support for perimenopausal and menopausal women. Cleanmarine® MenoMin® is rich in Omega-3 with Phospholipids, Vitamins B1, B2, B6, B12 and D3, as well as Rosemary Extract, Soy Isoflavones, Folate and Biotin.

“This is a very popular product in the pharmacy,” stated one of the judges. “It has an extremely loyal customer base with feedback relaying that it is an effective product - they notice results. The packaging is attractive and we have great support from the supplier and reps on training and product awareness.”

“Cleanmarine is a very wellrespected brand within the supplement category in Pharmacies. The fact it is an Irish brand, known for their high quality products puts Cleanmarine

Judges comments

MenoMin at the front of the pack for me”

Best Pain Relief Product

Voltarol Emulgel Extra Strength 2% w/w Gel won Best Pain Relief Product at the 2022 OTC & Retail Pharmacy Product Awards.

One of our esteemed members of the judging panel commented that this product ‘is very well-known due to the brand investing well in marketing, advertising and POS show material within pharmacies. Customers are loyal to the brand and usually ask for it by name at the pharmacy counter.’

Voltarol Emulgel Extra Strength 2% w/w Gel is a potent nonsteroidal anti-inflammatory drug (NSAID) with effective analgesic and anti-inflammatory properties. It has a low systemic exposure, meaning a reduced risk of systemic side effects and drug–drug interactions. That includes a reduced systemic side-effect risk vs oral NSAIDs (e.g. gastrointestinal events).

Voltarol Emulgel Extra Strength 2% w/w Gel has a unique formulation to help the anti-inflammatory ingredient get through the skin. It contains a permeation enhancer for increased delivery of diclofenac through the skin.

“Voltarol is a great topical treatment that has a potent non-steroidal anti-inflammatory drug (NSAID) with effective analgesic and antiinflammatory properties. They have a good TV ad campaign and provide good training materials to pharmacy staff. The packaging is nice, and the new easy-open cap is proven to be more intuitive, easier to open and preferred by patients, who may suffer from pain in their hands which is very important and a lovely feature”

Judges comments

Introducing the Voltarol Emulgel

Extra Strength 2% w/w Gel easy-to-open cap*

Powerful Anti-Inflammatory Provides All-Day Joint & Muscle Pain Relief**

Making life easier for your patients with pain in their hands

Contains a unique permeation enhancer – up to 3x increased skin permeation of diclofenac†1

Clinically proven to demonstrate deep penetration into tissue2

Reduces pain on movement – to help patients get moving again

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

*100g pack only. **with twice daily application. †compared with Voltarol Emulgel 1% in vitro study.

References: 1. Quartarone & Hasler-Nguyen 2014; GSK data on file. 2. Seefried et al. Ther Adv Musculoskel Dis (2020) Vol. 12: 1-13.

14 years and over: 2g to 4g of gel, applied topically 2 times daily – morning and evening. Maximum recommended treatment duration is 14 days. Patients should consult their doctor if the condition does not improve within 7 days or worsens. Contraindications: Patients with or without chronic asthma in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents. Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Hypersensitivity to any other ingredient of the gel. Use in third trimester of pregnancy. Use in children and adolescents aged less than 14 years. Warnings and precautions: Apply only to intact, non-diseased skin and not to skin wounds or open injuries. It should not be used with occlusion. It should not be allowed to come into contact with the eyes or mucous membranes and should never be taken by mouth. Application over extensive areas for prolonged periods or application in excess of recommended dosage may give rise to systemic effects. These include gastrointestinal disturbances and bleeding, irritability, fluid retention, rash, hepatitis, renal dysfunction, anaphylaxis and rarely blood dyscrasias, bronchospasm and erythema multiforme. Discontinue if rash develops. Use with caution in patients with a history of peptic ulcers, gastrointestinal bleeding, hepatic or renal insufficiency, or bleeding diathesis, or intestinal inflammation. Pregnancy and lactation: The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. Only use during lactation on the advice of a health professional. Contraindicated during the third trimester of pregnancy. Should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time. Side effects: Very rare: rash pustular, hypersensitivity (including urticaria), angioedema, asthma, photosensitivity reaction. Rare: Dermatitis bullous. Common: Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus. Overdose: The low systemic absorption of topical diclofenac renders overdosage extremely unlikely. MA Holder: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. MA Number: PA 678/140/3. Legal Category: Pharmacy only. Text revised: June 2020. Further information available on request. Contains diclofenac diethylammonium. Always read the label/leaflet. Trade marks are owned by or licensed to the GSK group of companies. PM-IE-VOLT-21-00011.

Product Information: Please consult the Summary of Product Characteristics for full product information. Voltarol Emulgel Extra Strength 2% w/w Gel (diclofenac). Indications: For the local symptomatic relief of pain and inflammation in trauma of tendons, ligaments, muscles and joints, localised forms of soft tissue rheumatism. Dosage: Adults and adolescents 14 years and over: 2g to 4g of gel, applied topically 2 times daily – morning and evening. Maximum recommended treatment duration is 14 days. Patients should consult their doctor if the condition does not improve within 7 days or worsens. Contraindications: Patients with or without chronic asthma in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents. Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Hypersensitivity to any other ingredient of the gel. Use in third trimester of pregnancy. Use in children and adolescents aged less than 14 years. Warnings and precautions: Apply only to intact, non-diseased skin and not to skin wounds or open injuries. It should not be used with occlusion. It should not be allowed to come into contact with the eyes or mucous membranes and should never be taken by mouth. Application over extensive areas for prolonged periods or application in excess of recommended dosage may give rise to systemic effects. These include gastrointestinal disturbances and bleeding, irritability, fluid retention, rash, hepatitis, renal dysfunction, anaphylaxis and rarely blood dyscrasias, bronchospasm and erythema multiforme. Discontinue if rash develops. Use with caution in patients with a history of peptic ulcers, gastrointestinal bleeding, hepatic or renal insufficiency, or bleeding diathesis, or intestinal inflammation. Pregnancy and lactation: The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. Only use during lactation on the advice of a health professional. Contraindicated during the third trimester of pregnancy. Should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time. Side effects: Very rare: rash pustular, hypersensitivity (including urticaria), angioedema, asthma, photosensitivity reaction. Rare: Dermatitis bullous. Common: Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus. Overdose: The low systemic absorption of topical diclofenac renders overdosage extremely unlikely. MA Holder: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. MA Number: PA 678/140/3. Legal Category: Pharmacy only. Text revised: June 2020. Further information available on request. Contains diclofenac diethylammonium. Always read the label/leaflet. Trade marks are owned by or licensed to the GSK group of companies. PM-IE-VOLT-21-00011.

Best Beauty Product

“This is an innovative product and part of the Revive range, which is hugely popular and sought after by customers,” stated one of our judges within the Best Beauty Product which went to Beauty Complex by Revive Active for 2022.

The judges added, “Well placed advertising has boosted sales and the product itself is attractively presented and of a very high quality.”

Beauty Complex contains a distinctive combination of eight active ingredients including Marine Collagen, Phytoceramides, Hyaluronic Acid and Biotin. It was designed by experts to compensate for declining collagen, ceramides and hyaluronic acid in the body.

“The branding of this product is in keeping with the branding that people have grown to associate with Revive products. The packaging contains lots of information regarding the ingredients and their uses, thereby, allowing customers to make informed decisions before purchasing. The Beauty Complex formula is unique in that it contains all the ingredients needed to obtain and maintain healthier hair, skin and nails. This will improve compliance and therefore, results for customers”

Judges comments

Best Launch of the Year

Year for 2022 went to Volatrol

Extra Strength 2% w/w Gel 100g.

The 100g-pack launch combined all the existing benefits of Voltarol Emulgel

Extra Strength 2% w/w Gel with a new easy-open cap that is proven to be more intuitive, easier to open and preferred by patients, who may suffer from pain in their hands. The larger pack also provides greater value for patients, with one 100mg tube equivalent to 72 x 200mg tablets of ibuprofen.

Commented the judges, “This is an excellent product in that it is the only one of its’ strength available on the market. Good pharmacy point of sale materials are also provided. This is a reputable brand and reliable product. My customers are delighted to be able to get this high strength product over the counter.”

Judges comments

“Great brand extension and identification of additional consumer needs. Loyalty to the brand already established. Better consumer experience created through range extension and brand support through pharmacies”

Emulgel

Best Pregnancy/ Fertility Product

Best Pregnancy/Fertility Product went to Active Iron Pregnancy Plus, which the judges described as ‘a fantastic product which, when first appearing on the market, provided pharmacy staff with a product they could recommend to patients unable to tolerate iron supplements due to their GI side effects.’

Active Iron is an Irish iron supplement brand that is clinically proven to increase iron levels while helping to avoid the negative gastrointestinal side effects commonly associated with iron.

Award winning Active Iron Pregnancy Plus is the complete nutritional solution for mum and baby throughout pregnancy, containing three key components:

- Non-constipating Active Iron capsule, clinically proven to increase iron.

- Specially formulated to enhance absorption, a complete multivitamin tablet with 20 essential vitamins and minerals including folic acid as L-methylfolate and vitamin D.

- 100% sustainably sourced omega-3 DHA fish oil capsule.

Solvotrin Therapeutics CFO George Walsh said, “We are delighted that Active Iron Pregnancy Plus has been recognised as the best pregnancy supplement in the market. The combination of Active Iron’s clinically proven formula with a specially formulated multivitamin and omega 3 makes Active Iron Pregnancy Plus the optimum pregnancy product and we are delighted to hear that pharmacists all around the country continue to recommend it.”

“With 21 essential nutrients to provide complete nutritional support to mum and baby throughout pregnancy I think this is an excellent product. They provide product awareness by attending national midwife events, webinars, courses and tools for midwifes and also samples. They also have great digital marketing and provide excellent training to pharmacy staff. Packaging is great and sends out a clear message to the customer of what the product is providing”

Judges comments

Best Baby Skincare Product

“Elave is a well-known and trusted brand name; it is often asked for by customers and is one I feel comfortable recommending regularly.” This was just one of the judges comments on Elave Baby Bath ECOCERT Organic which won the category for Best Baby Skincare Product.

The judge added, “There are no harsh chemicals within their products, and you can be confident they will be suitable for sensitive skin. This is especially important in the case of newborns and babys’ delicate skin.”

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

“This brand is a well-loved Irish brand that is trusted in the market, especially with parents. Elave as a brand always supports with investment; and have increased their social media presence over the last 12-18 months which is driving the brand awareness”

Judges comments

Best Marketing/ Training Campaign

Viagra Connect won the Best Marketing/Training Campaign Award for 2022 with one of the judges stating that its launch ‘has been exceptional and has led to more awareness of erectile dysfunction and men being more forth coming to seek treatment.’

They added, “The support to our pharmacy was invaluable with the Essential Guidelines and Consultation Guide being posted out. In addition, the webinar was very helpful to consolidate the information and hearing from a pharmacist in Northern Ireland about his experience with selling Viagra Connect really gave me the confidence in my ability to provide the product.”

Viagra Connect is the first over-the counter treatment for erectile dysfunction (ED) for men age 18 years and older to be launched in the Republic of Ireland. The Viagra Connect educational campaign for pharmacists was initiated prior to Viagra Connect being available to purchase in the pharmacy – providing guidance on ED and relevant medical issues relevant for their patients.

“Having this product on the market for customers has made the topic of erectile dysfunction more normalised. The campaign has really opened the doors to allow people not to feel like they are on their own. The company has also provided continued support to pharmacists”

Judges comments

Best VMS Product

The Best VMS Product Award for 2022 went to Zest Active.

Zest Active is an innovative super supplement from Irish Supplement company Revive Active. It is scientifically formulated with 25 active ingredients including vitamins, minerals, amino acids and Wellmune®, all carefully selected to support energy, the immune system, brain, and muscle function.

“Zest Active is a really good seller within our pharmacy and is a product people ask for by name,” commented one of the judges. “One of its unique selling points is that it is marketed as having all the ingredients needed to maintain a busy lifestyle and/or combat fatigue. Great product information supported with market leading branding and pharmacy support.”

Zest Active contains no caffeine, binders or fillers and is Informed Sport approved, giving both professional and amateur athletes confidence to use. With a refreshing orange flavoured blend, Zest Active delivers the daily nutrients you need, to help you unlock your true potential.

“Super product, Great USP and Irish. Tastes good and easy for on the go. Great competitor to existing energy products. Again once tried great repeat sales” Judges comments

Best Digestive Product

Alflorex

This probiotic is taken daily to manage and prevent recurrence of IBS symptoms. 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 longterm aim for Alflorex is to strive to have all IBS patients in Ireland take Alflorex for 1 month.

For one of our judges, Alflorex is one of their favourite products in the pharmacy. “IBS is such a common presentation to the pharmacy and undiagnosed in many cases as they are symptoms that some people are too embarrassed to present to the pharmacy with. The research behind this product is exemplary and the support from Pamex as witnessed is first-hand and is second-to-none,” they add.

Judges comments

“The product that started the new tempo of digestive aids in Ireland. Though the bar has since gotten ever so slightly higher, this would not have happened but for Alflorexs’ original formula. Excellent product”

® - the leading probiotic for IBS, a condition that affects up to 1 in 7 people in Ireland every day, scooped the Best Digestive Product 2022.

Best Baby & Children Product

Nelsons Teetha won the category for Best Baby and Children’s Product within the 2022 OTC & Retail Pharmacy Product Awards.

Teetha® Teething Granules is a homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of teething pain and the symptoms associated with teething which are sore and tender gums, flushed cheeks and dribbling. Containing Chamomilla 6c, Teetha granules are packed in super convenient sachets and are quickly dissolving.

“Teetha has been loved by Irish Mums for years. One of our judges commented, “Nelsons teetha is a well-known and wellused product in the market - one of the top sellers for teething babies over 3 months. The product works well and once the consumer tries it, they are usually loyal to brand.”

“A go-to product for all parents of young infants. They’re easy to use and the individual sachets mean they can be kept in multiple rooms/bags/pockets so parents always have something close to hand when needed to provide relief to their teething infants”

Judges comments

Best Skincare Product

The Best Skincare Product for 2022 went to Elave Daily Defence, a brand that our judges say is synonymous with protecting the skin.

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

“This brand’s experience in producing traditional apothecary products like their Silcock’s Base, Aqueous Cream and Emulsifying Ointment has enabled them to leverage dermatological advances.” remarked a judge. “Elave can be recommended for those with inflammatory skin conditions such as eczema, whose skin can be further irritated by perfumes found in many moisturisers and sun creams.”

One of the judges commented, “This well-known and trusted brand has great clinical packaging and fantastic repeat sales, which is evident as once customers find something that truly works for their skin they will continue to use it.”

Judges comments

“Elave Daily Defence SPF45 is a really superb, market leading product from a well-known and highly trusted brand”

Promoting good oral health since 1965

Developed in collaboration with dental experts, TePe is the UK’s No. 1 selling Interdental Brush (IDB) and most recommended by dental hygienists.* IDB’s are highly effective in removing dental plaque between teeth and TePe offers a wide range in multiple sizes and handle lengths to suit everybody.

We’re using a range of initiatives from raw materials to energy supply that reduces our IDBs carbon footprint by 80% – without compromising on product quality, efficiency or design. Get

Best Oral Health Product

TePe Interdental Brush was voted as the winner of the Best Oral Health Product for 2022.

The Interdental Brush is a special brush by TePe designed to clean even the smallest gaps between the teeth where a regular toothbrush is unable to reach, giving gums and teeth a fresh and clean feeling - every day.

A functional design with an ergonomically shaped handle and a flexible neck guarantee optimal access to the hardest-to-reach areas / Ideal for braces, implants, crowns as well as natural teeth. TePe Interdental Brushes come in a range of sizes, designs, and filament types.

“TePe interdental brushes have been around a long time and have a very loyal customer basis,” stated one of the judges. “Pharmacists and dentists know the value and effectiveness of using these brushes and so we often recommend them. They have an excellent product range, particularly reputable and sought after by customers.”

Judges comments

“This is a hugely effective product; this brand dominates the category”

Best Sleep/ Stress Relief Product

Nytol One-A-Night won the Category Award for Best Sleep/ Stress Relief Product.

Nytol One-A-Night is available over the counter in pharmacy only. Nytol One a Night can help with all round sleep cycle support; helping consumers to drift off gently, improve quality of sleep and wake up feeling refreshed.

“The brand loyalty has been exceptional with this product,” stated one of the judges. “It is a unique product in the category.” Another added, “This is an invaluable product to have in store; to actually be able to offer a customer an effective solution to regain their sleep pattern without having to visit their GP. Customers ask for the product by name with many saying they were recommended it by a friend who found it helped to regulate their sleep cycle. The company are extremely supportive with the training and advertising material that they provide in store. They have also made massive investment in their TV advertising while also thinking outside the box by using Programmatic Audio – a unique element of the campaign, allowing consumers to listen to the Nytol Ad via online platforms like Spotify.”

“Great marketing campagin around this – definitely the driver in this category”

Judges comments

Key to Customer Retention Success? Know your Customer!

Acquire, acquire, acquire was the mantra of the last few years, particularly for those new to the online space, however for 2022 and beyond it is all about retaining those hard earned acquired customers.

Diminishing returns on online advertising, spiralling shipping costs and increased competition means that now is the time for ambitious retailers to identify how to differentiate from the competition, and focus on a higher ROI from a loyal customer.

Know Your Customer and Personalise their Experience

At the heart of customer retention is knowing your customer. Brands that listen and speak to their customers have a distinct advantage. Your customer base may have changed recently, ask yourself do you know your new customers?

Customers want to feel like the Retailer already knows their preferences, it’s similar to the experience of going to the local shop 20 years ago and the shopkeeper having the daily paper ready for you.

Use personalisation services to customise their online shopping experience and make recommendations based on individual browsing histories.

Email & SMS Marketing are excellent means of staying connected with customers:

thank them for their purchase, make recommendations based on purchases, tell them you miss them or wish them a happy birthday with a discount code.

Think Retail, not online versus physical stores

The most successful Retailers don’t think of online retail and physical retail as separate functions, it’s all Retail!

Your customer could see a product on your Instagram page, order it online via your website but return it in-store OR see a product in-store and go home and buy it later online. According to Forbes, “Today’s consumers peruse up to 10 sources of information before making a decision. And 42% of in-store shoppers search for information online at the same time as browsing in-store.” Consider using tablets in-store so shoppers can browse your online stock.

Ensure that your various marketing channels are synced and do not function independently. It’s vital that the shop floor staff are aware of what new products are added to the online store, the ecommerce team know what the social media team posts about, and the social

media team know if deliveries are on track – everyone needs to know everyone’s business!

Build Trust and a feeling of Community

Trust is one of the most important commodities in Retail. More than ever, customers expect Retailers to be transparent, reliable and accessible but customers in 2022 also want to buy from Retailers that they believe align with their own values. As a Retailer, it’s fundamental that you communicate your brand and ethos with consistency - from shop floor, to online and customer experience.

Be available to your customers where they spend most of their time. This is increasingly on social media. Live video, live chat, user generated content and Influencers are just some ways to build a community of followers. Don’t forget the importance of the overall customer experience in building a trusting relationship. Everything from their first interaction with you, to transparent and fair delivery and returns policies are crucial in developing relationships.

Make shopping with you an easy and enjoyable experience, always be vigilant and never let customers down, knowing that the moment you do, they will find other places to spend their money.

Reward Loyalty

Customers who show their loyalty deserve your recognition.

Consider implementing a loyalty programme, whether it’s a points based system or referral programme. According to research conducted by Accenture Interactive, “Members of retailers’ customer loyalty programs generate between 12% and 18% more revenue for retailers than customers who are not members of the loyalty programs.”

Surprise and delight your customers regularly. Add free samples with orders, go above and beyond with customer service, or offer a discount on next purchase. Achieving success in rewarding your customers is treating everyone equally whether they shop online, in-store or both.

Think Sustainability

An emerging opportunity for 2022 is embracing sustainable business practices. Research shows that customers are more likely to purchase from brands that demonstrate a sustainability commitment. Sourcing eco-friendly materials, the consolidation of shipments, reducing the distance packages travel and minimising paper and packaging used for shipments and returns are ways that Retailers can contribute to a more sustainable future.

Remember you won’t earn loyalty in just one day, you must earn it every day!

www.magico.com

“At the heart of customer retention is knowing your customer. Brands that listen and speak to their customers have a distinct advantage. Your customer base may have changed recently, ask yourself do you know your new customers?”

Reminder of Precautions to avoid Photosensitivit y Reac tions with Fastum Gel

A. Menarini Pharmaceuticals Ireland Ltd. wish to remind healthcare professionals of the necessary precautions to avoid the risk of photosensitivity reactions with Fastum Gel.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) undertook a safety review of topical ketoprofencontaining medicines in 2010 and recommended that doctors should strictly follow the contraindications when prescribing topical ketoprofen. CHMP also recommended that doctors and pharmacists should inform patients on how to use these medicines appropriately to prevent the occurrence of serious skin photosensitivity reactions. A series of risk minimisation measures for Fastum Gel was agreed with the Health Products Regulatory Authority. The Summary of Product Characteristics and the Patient Information Leaflet were updated accordingly and may be found on www.medicines.ie and www.hpra.ie.

Patients should be reminded to wash their hands thoroughly after application of the product and to protect treated areas from sunlight by wearing clothing. They should avoid exposing the treated areas to sunlight, even if cloudy, or UVA from sunbeds or solarium during use and for 2 weeks after discontinuation. In addition they should be advised to avoid using Fastum Gel under occlusive bandages and to discontinue Fastum Gel immediately and contact their doctor should any skin reaction develop, including cutaneous reactions after co-application of octocrylene-containing products.

A copy of the patient educational leaflet is available from A. Menarini on 01 284 6744 or 1800 283045 or is available at www.hpra.ie

A. Menarini would like to remind healthcare professionals that any suspected adverse reactions associated with the use of Fastum Gel should be reported to the Health Products Regulatory Authority at www.hpra.ie or by e-mailing medsafety@hpra.ie. Adverse reactions can also be reported to A. Menarini’s Pharmacovigilance Department on 01 284 6744.

Topic Team Training – Sleep Disorders

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

Restless legs syndrome (RLS) is a neurological sleep disorder. It is also called Willis-Elbom disease (WED). Prevalence of RLS ranges from 0.6% to 15% of the population. This increases to 27% in pregnant females. The disorder is defined by the classic clinical symptoms of an overwhelming urge to move the legs while resting in the evening and night. This is accompanied by an uncomfortable/unpleasant sensation in the legs with patients often describing it as a crawling sensation. Symptoms are partially or totally relieved by walking or stretching the legs.

Evidence-based patient questionnaires can be used to help guide the pharmacist as to the nature of the sleep disturbance. Some of the most popular and most beneficial include:

Insomnia Severity Scale (ISS)

Epworth Sleepiness Scale (ESS)

Stanford Sleepiness Scale (SSS)

RLS Screening Questionnaire (RLSSQ)

STOP and STOP-Bang Questionnaire (STOP)

The below information, considerations and checklist provide support to enable you to run a team training session and identify opportunities for learning within the topic of Sleep Disorders

Effects of Sleep Disorders

Early recognition and treatment of common sleep disorders helps to minimise significant health, social and fiscal consequences. Community pharmacy is recognised as a valuable and trusted public health resource within this field.

Insomnia disorder has a prevalence of between 6% and 20%. This increases to between 30% and 48% of the general population at a symptom level. Being older, female, or being from a socioeconomic background are independent risk factors for the development of insomnia. Having a previous episode of insomnia also increases the risk of a future episode.

Three classification systems exists for the definition of insomnia,

Consider:

International Classification of Diseases (ICD), Diagnostic and Statistical Manual of Mental Disorders (DSM) and International Classification of Sleep Disorders (ICSD).

Pharmacological treatment for insomnia should be limited to short term use only, if CBT-I is unavailable or if a patient does not respond to CBT-I. Available substances that are commonly used include benzodiazepines (BZ), benzodiazepine receptor agonists (BZRA), antidepressants, anti-psychotics, antihistamines, phytotherapeutic substances and melatonin. All medications prescribed for sleep disturbances should be monitored carefully and assessed for any emergence of adverse side effects. Patients should always be made aware of potential interactions with other medications and OTC medications they may be prescribed and the possibility of exacerbation of underlying medical conditions.

 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?

Obstructive sleep apnea syndrome is the most common respiratory disorder of sleep with a prevalence of at least 4% in the general population, and twice as common in males as females. It is a complex disorder characterised by brief interruptions in breathing which are a result of mechanical factors that increase the collapsibility of the upper airway. The most common associated nocturnal symptoms include snoring, gasping or choking, witnessed apneas, nocturia, frequent awakenings, enuresis and nightmares.

Key Points: Check your pharmacy team are aware and understand the following 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 sleep aids and herbal remedies, differ

A starting conversation around sleep can uncover and address any unhealthy sleep practices that may be present. Healthy sleep practices, known as sleep hygiene include limiting caffeine products, structured meal times, exercise, avoiding phone use in the lead up to bedtime and addressing the bedroom environment ensuring its cool, dark, quiet.

Further Assistance:

Management of Sleep Disorders

Continuing Professional Development Module, Irish Pharmacy News Issue March 2022 – pages 41-44

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

*To verify contact: verify@perrigo.com. Based on IQVIA sales data.

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: sedation, drowsiness, disturbance in attention, unsteadiness, dizziness, thrombocytopenia, hypersensitivity reactions, confusion, paradoxical excitation, convulsions, headache, paraesthesia, dyskinesias, blurred vision, tachycardia, palpitations, thickening of bronchial secretions, dry mouth, gastrointestinal disturbance, muscle twitching, urinary difficulty, urinary retention, fatigue. Legal classification: P: PA1186/016/001

MAH: Chefaro Ireland

SPC: https://www.medicines.ie/medicines/nytol-one-a-night-50-mg-tablets-34889/smpc

DAC. The Sharp Building. Hogan Place. Dublin 2. Ireland.

Taking the Stigma out of Stoma

Hints and tips on how to engage your ostomy patients

United Drug were delighted to welcome back Coloplast for another Ostomy webinar session in February. In addition to their dedicated Ostomy Care Team, United Drug partner with their suppliers to disseminate as much educational material as possible in their ongoing mission to help their

customers to reach out to their Ostomy patients and offer the care and support they need. Their aim is to provide a service that includes educational materials, customer support and an extensive product range, all of which ensures better quality of life and patient care where possible.

The webinar was led by Lucy Fitzgerald, a Coloplast Ostomy Nurse and she touched on the top 5 frequently asked questions by ostomy patients. The goal was to help empower pharmacists to chat confidently to ostomates and help them get the support that suits their individual needs. The discussion also identified and reviewed patient needs, treatments, useful tips, and guidance on how best to interact with the ostomates at the pharmacy. Lucy also provided an information booklet, launched recently by Coloplast to assist the pharmacist to have better conversations with Ostomates. Access the video and webinar materials:

To access the webinar recording, please logon to www.udw.ie where you will find the video recap and its materials within our resource hub. The webinar materials can be found in the description box of the video recording.

Irish Pharmacies – Family Businesses Under Threat

The role of the community pharmacist is akin to the role of the community GP or the local vet. The family-owned pharmacy provides a much broader role than just dispensing. They are a key part of the network that binds a community together. However, “family-owned” needs to be re-defined in marketing terms to re-establish itself as a competitive advantage.

The industry will continue to consolidate and more big chains such as Bestway enter the market will is under threat. So, does “family-owned” matter to the consumer?

The answer is no unless you find a way to differentiate yourself. This leads on to many family discussions regarding the future of our family-owned pharmacy or pharmacies. Do we stay independent, do we join a buying/ marketing group, or do we sell?

If you are a pharmacy owner and you have no children interested in joining the business, then the decision is easy.

If you are a pharmacy owner and you have children interested in joining the business, the decisions regarding the future are not so clear-cut.

Owning and working as an independent pharmacist today can be difficult. Besides the business

aspects of increased competition, increased administration, declining margins, increased costs etc, the human aspect of the business can be the most taxing. The increased administration means that many community pharmacists have to bring work home at night. To take time off, you need to find a suitably qualified replacement. Finding a locum can be very difficult, especially in rural areas.

It is never too early to have a family discussion about the future of the family business. It is more common for families to either avoid the discussion or to be discussing the future of the business when it is too late.

If one or more of your children have spend five years of education and training to become a pharmacist with the expectation of taking over the family business and during this time you decide to sell, this can be very disheartening for the children.

Selling might be the right decision for a number of reasons, not just that you got an offer you couldn’t refuse. You may, as a family, believe the days are numbered for an independent pharmacy in your area because competition is coming to town. There can be a whole host of reasons that make selling the right decision, but this should be discussed openly and honestly with the family.

You may have always imagined your pharmacy as staying in the family and passing the business on to the next generation. Very often, the next generation have a different view of how to bring the business forward and many next generation pharmacists have transformed the business once they have been given control.

In terms of succession planning, “retirement” is a difficult area for many families. It is quite common for two generations to be working in the pharmacy, but with the

Lucy was also joined by Kathy Daly, an Ostomy patient. K athy gave an invaluable insight from her perspective on how important the community pharmacist is to her care and how this additional community support can assist in helping ostomates to live a full and comfortable life.

Webinar Key Takeaways:

• Effective ways to have the conversation with your ostomy patients

• Correct usage of technical product language for discussions with ostomates

• Answering the most common questions retail pharmacies get asked

• Enhance your knowledge with additional sources of information

Ostomy Customer Care

01 463 2300 | Visit www.udw.ie

“owner” fully in charge. The children are merely “employees”. The transfer of “ownership” may not happen until the owner dies and, in many cases, the children are middle aged adults when this happens. It can be difficult to “let go”.

In my book, The Family Business Book, I give practical tips to help families navigate their way through all these type of issues.

Women’s Health Action Plan

On International Women’s Day and as part of Women’s Health Week 2022, the Minister for Health Stephen Donnelly has launched the Women’s Health Action Plan 2022-2023, the first Women’s Health Action Plan published in Ireland.

Managing Obesity

• ¤5.3 million to grow access to “see and treat” gynaecology clinics (20 nationally); specialist menopause clinics (4 nationally); and specialist endometriosis services (2 nationally)

• ¤5 million to bring the Women’s Health Fund to an investment of ¤10 million to support innovative new approaches to women’s health nationwide (illustrated in this Plan)

Irish and German scientists have just identified how specific immune cells can work together in fat to cause inflammation that leads to weight gain and obesity. Their work pinpoints new avenues to exploit the regulation of that inflammation in fat tissue, thereby suggesting new ways to manage obesity.

There is a global epidemic in obesity in adults and children, with obese people predisposed to develop diabetes, cardiovascular disease, and cancer. New therapies are needed to help tackle this issue.

The Action Plan was developed by the Department of Health in partnership with the HSE, the National Women and Infants Health Programme, the European Institute for Women’s Health, the Irish College of General Practitioners, and the National Women’s Council of Ireland through the work of the Women’s Health Taskforce.

The Action Plan sets out women’s priorities for women’s health. It is underpinned by the voices and perspectives of women, their advocates and women’s health professionals who have provided their insights and experiences

through a range of listening projects and engagements undertaken by the Women’s Health Taskforce 2020-2021.

Women’s health is a top priority for this government and is strongly supported in Budget 2022 with ¤31 million additional funding for new developments in women’s health. This funding will enable:

• ¤8.66 million additional funding for continued implementation of the National Maternity Strategy

• ¤9 million to fund access to contraception for women aged 17-25

Orla O’Connor, Director of the National Women’s Council and member of the Women’s Health Taskforce welcomed the launch of the Action Plan, “The Women’s Health Taskforce made the conscious decision to put women’s voices at the heart of health policy and implementation, and this Plan seeks to deliver on what many women shared through the ‘Radical Listening’ exercise - an ask for a person-centred and accessible health system, which works to meet women’s needs as they arise. This Plan provides strong steps towards building that future for women in Ireland and our task is now to drive forward these actions that will be the critical levers for delivering meaningful change.”

Link between High Cholesterol and

Heart

In their research, the scientists identified how “checkpoint proteins” and immune cells alter inflammatory cells within the fat tissue to cause obesity. In people with obesity (Body Mass Index BMI> 30 kg/m2) these changes in checkpoint expression in the visceral fat was predictive of the person’s weight.

The scientists then showed that modifications in the so-called immune checkpoint proteins of mice on a Western “high fat” diet were linked to dramatic reductions in the development of obesity and diabetes.

New

research from RCSI University of Medicine and Health Sciences has revealed that the link between ‘bad’ cholesterol (LDL-C) and poor health outcomes, such as heart attack and stroke, may not be as strong as previously thought.

Published in JAMA Internal Medicine, the research questions the efficacy of statins when prescribed with the aim of lowering LDL-C and therefore reducing the risk of cardiovascular disease (CVD).

Previous research has suggested that using statins to lower LDL-C positively affects health outcomes, and this is reflected in the various iterations of expert guidelines for the prevention of CVD. Statins are now commonly prescribed by doctors, with one third of Irish adults over the age of 50 taking statins, according to previous research.

The new findings contradict this theory, finding that this relationship was not as strong as previously thought. Instead,

the research demonstrates that lowering LDL-C using statins had an inconsistent and inconclusive impact on CVD outcomes such as myocardial infarction (MI), stoke, and all-cause mortality.

In addition, it indicates that the overall benefit of taking statins may be small and will vary depending on an individual’s personal risk factors.

The lead author on the paper is Dr Paula Byrne from the HRB Centre for Primary Care Research based in RCSI’s Department of General Practice. Commenting on the findings, Dr Byrne said: “The message has long been that lowering your cholesterol will reduce your risk of heart disease, and that statins help

to achieve this. However, our research indicates that, in reality, the benefits of taking statins are varied and can be quite modest.”

The researchers go on to suggest that this updated information should be communicated to patients through informed clinical decision-making and updated clinical guidelines and policy.

This important discovery was a collaboration with Professor Susan M Smith, also of RCSI and with researchers from the University of New Mexico, USA, (Dr Robert DuBroff), the Institute for Scientific Freedom in Denmark (Dr Maryanne Demasi), Bond University in Australia (Dr Mark Jones) and independent researcher Dr Kirsty O’Brien.

The study, just published in the leading international biomedical journal Science Translational Medicine, was led by Professor Padraic Fallon from Trinity College Dublin’s School of Medicine, and Dr Christian Schwartz, a former EMBO Fellow in Trinity and now a Principal Investigator at the University Hospital Erlangen.

Professor Fallon, who is based in the Trinity Biomedical Sciences Institute, commented, “This new process of checkpoint regulation of cells in visceral fat of obese individuals advances our understanding of how the immune system controls diet-induced weight gain that can lead to conditions such as obesity and type 2 diabetes.

“Our discovery has broader impacts on addressing how obesity influences co-morbidity with other diseases, as shown in the COVID-19 pandemic, where obese individuals that are infected with SARS-CoV-2 are more likely to develop severe disease that requires intensive care and also have an increased risk of mortality.”

Disease ‘Inconsistent’

Anticoagulation in Atrial Fibrillation: The Role of the Pharmacist

Christine is the lead clinical pharmacist in Tallaght University Hospital’s interdisciplinary Atrial Fibrillation clinic. Christine’s primary role is in the area of anticoagulation with direct oral anticoagulants for patients with Atrial Fibrillation. In this article she outlines some of the main practice points for pharmacists to be aware of when looking after these patients and highlights some useful reference sources.

Introduction

Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia affecting at least 3% of the Irish population currently. AF is an age-related condition with worldwide prevalence predicted to more than double

in the coming decades. This presents a significant health burden as almost one in every three strokes are associated with AF and AF-related strokes tend to be more severe, posing the greatest risk for neurological disability.

Management of AF generally includes the implementation of either a rate or rhythm control strategy and for most patients, initiation of oral anticoagulation (OAC) to prevent stroke.

The risk of stroke is calculated using the CHA2DS2-VASc Score as outlined in Table 1. For most patients with AF we err on the side of anticoagulation. The European Society of Cardiology (ESC) recommends that all patients scoring 1 or greater should be considered for OAC (except females scoring only 1 on the basis of gender alone who are considered low risk).

Direct Oral Anticoagulants (DOACs) have widely replaced warfarin as the agents of choice due to their efficacy, convenience and reduced, but by no means eliminated, potential for interactions. As increasing age is a prominent AF risk factor, all patients with AF will eventually qualify for lifelong anticoagulation therapy and so it is really important for pharmacists to have an in-depth understanding of these medications.

DOAC Dosing and Method of Administration

There are four DOACs currently available – dabigatran, apixaban, rivaroxaban and edoxaban. All are licensed for a number of different indications and have different dose reduction criteria. The HSE medicines management programme have produced a succinct table1 which amalgamates the information from the four individual summary of product characteristics (SPCs) and is very useful as a quick reference guide. All four DOACs are renally cleared to some degree. Therefore creatinine clearance must be calculated using the Cockroft and Gault equation at initiation of therapy and recalculated periodically to ensure accurate dose selection. In hospital, with access to laboratory results, one of the primary roles of the pharmacist in relation to anticoagulant therapy is confirmation that the patient is prescribed the appropriate dose for their renal function. Both over- and under- dosing in the area of anticoagulation puts the patient at risk of the severe consequences of either a serious bleeding event or stroke.

There are however a number of checks that can be performed in the community pharmacy setting to ensure safe DOAC prescribing and dispensing without the need to access laboratory results.

Pharmacists and their teams should ensure an appropriate dosing schedule has been prescribed for the specific indication. Apixaban and dabigatran should always be prescribed twice daily in the setting of AF and any alternative dosing schedule should be queried.

Where patients have their medications blister packed in a Monitored Dosage System (MDS) by the pharmacy team it is important to ensure the DOAC times of administration are spaced appropriately. In the case of twice daily DOACs the administration times should ideally be at 12 hourly intervals.

Dabigatran is not suitable for MDS dispensing and should always be supplied to the patient in its original packaging. Where patient adherence would be compromised by supplying dabigatran separately this should be discussed with the prescriber. There is likely an alternative DOAC the patient could be switched to which is suitable for MDS dispensing, thereby increasing adherence and safety.

It is possible to confirm that an appropriate dose of DOAC has been prescribed in some situations. For example a reduced dose of dabigatran is recommend for all patients 80 years and over and the presence of certain P-glycoprotein (P-gp) inhibitors necessitates a licensed dose reduction for both edoxaban and dabigatran. Where such cases are encountered in the pharmacy it should be flagged to the prescriber and a dose reduction recommended.

There are other prescribing decisions which are less clear-cut e.g. where patients prescribed dabigatran are between 75 and 80 years old or have gastritis. In these cases prescribers are advised to consider a dose reduction. These decisions are made on a risk-benefit basis and it can be difficult for pharmacists to make meaningful clinical

interventions around dosing for these patients in the absence of a full clinical history.

Patient Education and Adherence

Patient and carer education is one of the most important interventions by healthcare professionals (HCPs) for patients on DOACs. In-depth education should be provided at initiation of DOAC therapy and reinforced periodically thereafter. Patients should be counselled on the following pointsindication for DOAC therapy, importance of strict adherence (no DOAC = no protection from stroke), modality of intake (once or twice daily, intake with food for rivaroxaban etc.), management of missed doses, increased risk of bleeding, over the counter medications to avoid and advice given to inform HCPs of DOAC therapy in advance planned procedures (dentist etc.).

Written information should be provided. An alert card is included in the packaging of each of the four DOACs and patients should be advised to carry this on their person at all times. The Irish Medication Safety Network (IMSN) have produced a patient information booklet on anticoagulation in AF. It contains information on the condition of AF and includes general and specific information on all four DOACs. It can be accessed, along with the link to a patient safety video, on the IMSN website (https://imsn.ie/direct-oralanticoagulants-doacs/) or hard copies can be ordered from Bayer. (dominic.redmond@bayer.com).

Adherence should be assessed on an ongoing basis. Asking patients in a non-judgemental way whether they have missed any doses of medication recently can open this conversation. Twice daily dosing regimens have been associated with reduced adherence. Patients who report missing doses of a twice daily DOAC despite adequate education should be advised that there are once daily DOAC options available and should be referred to the prescriber for consideration of a switch in therapy.

Interactions

Interactions affecting DOACs can be pharmacokinetic or pharmacodynamic in nature. For the most part information on important interactions can be found in the SPC and/or the BNF - reference sources familiar to all pharmacists. The European Heart Rhythm Association (EHRA) have produced a Practical Guide2 on many different aspects of DOAC therapy in AF. The guide was first produced in 2013 and is currently in its third iteration. It contains a wealth of information in relation to DOAC prescribing and ongoing monitoring and is one of the key references I consult regularly. The EHRA guide includes an extensive section on DOAC interactions which is a really useful resource for pharmacists in practice.

DOAC pharmacokinetics are affected by concomitant administration of medications which either inhibit or induce the P-gp transporter and/or CYP3A4 isoenzyme. Some combinations such as dabigatran and the P-gp inhibitor dronedarone are contraindicated by the manufacturer due to an unacceptable increase in plasma concentrations of DOAC.

The EHRA guide contains information on additional potential interactions not included in the SPCs and also provides some guidance around instances where a patient may have more than one risk factor affecting DOAC plasma levels present.

Clinically relevant pharmacodynamic drug-drug interactions generally involve the co-prescription of medications which increase the risk of bleeding. Patients taking DOACs should be advised to avoid the use of non-steroidal anti-inflammatory drugs. The concomitant administration of a low dose antiplatelet such as aspirin or clopidogrel with a DOAC is indicated in some instances. However, pharmacists should query the ongoing need for antiplatelet therapy in patients who are newly prescribed a DOAC. Where the indication for the antiplatelet was primary prevention it should be discontinued to minimise the bleeding risk.

A complex scenario arises when AF patients undergo coronary stenting. Such patients will require a period of treatment with “triple therapy” following their stenting procedure i.e. dual antiplatelet therapy (with clopidogrel and aspirin) and a DOAC. Where such a situation arises clear instruction from the cardiology team in secondary care should be communicated to the patient, the GP and the pharmacist outlining the short, intermediate and long-term plan for antiplatelet and DOAC therapy.

In most instances DOACs should not be prescribed alongside other anticoagulants and any such prescription should be clarified with the prescriber. An exception however is the scenario where a patient is switching from DOAC to warfarin therapy where continuation of DOAC may be required for a number of days due to the slow onset of action of warfarin. Full details on switching between anticoagulants is discussed in detail in the EHRA guide.

Selective serotonin reuptake inhibitors (SSRIs), and other antidepressants with affinity for serotonin receptors, are associated with an increased risk of bleeding. This risk increases further in the presence of DOACs. Where a combination of medications which increase a patients bleeding risk are co-prescribed, it’s worth highlighting that gastroprotection with a proton pump inhibitor or H2-receptor antagonists should be considered.

Conclusion

DOACs are an essential treatment for the prevention of stroke in patients with AF. They are also high-risk medications. Pharmacists and their teams in community are central to ensuring the safe and effective use of DOACs through patient education, adherence checks and regular medication review.

References

1. Medicines Management Programme HSE: Anticoagulation Prescribing Tips. https://www.hse.ie/ eng/about/who/cspd/ncps/medicines-management/ oral-anticoagulants/ (2020). Accessed 27/02/2022.

2. Steffel J, Collins R, Antz M, Cornu P, Desteghe L, Haeusler KG, et al. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation. EP Europace. 2021;23(10):1612-76. doi: 10.1093/europace/euab065.

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Can value be found in volatility?

Can Value be Found in Volatility?

Market volatility is the value investors best friend. Without it buying shares at discounted prices could never happen. The value investor concept first developed by Columbia professors Benjamin Graham and David Dodd became very popular following Grahams 1949 book “The Intelligent Investor” and after all who would not want that title applied to themselves.

Kieran Moore QFA, SIA and his business Moore Wealth Management have been advising the Irish Pharmacy Community for over 20 years. He can be contacted on 086-3801868, kieran@mwm.ie or www.mwm.ie

The MCSI World stock index is down 9.1% at the time of writing. January saw declines primarily linked to the American Federal Reserves faster than expected stance on raising interest rates this year to combat US inflation. February has seen a further decline linked to the Russian invasion of Ukraine.

Market volatility is the value investors' best friend. Without it buying shares at discounted prices could never happen. The value investor concept first developed by Columbia professors Benjamin Graham and David Dodd became very popular following Grahams' 1949 book “The Intelligent Investor” and after all who would not want that title applied to themselves.

So what does all this mean?

The most famous follower of the principles put forward in the book includes Grahams one time student Warren Buffet regarded as the most successful investor ever. Within the various theories on investing two major theories stand out in contrast to each other. Those who follow the Efficient Market theory and those who side with the Value Investing theory.

Market volatility is the value investors’ best friend. Without it buying shares at discounted prices could never happen.

The value investor concept first developed by Columbia professors Benjamin Graham and David Dodd became very popular following Grahams’ 1949 book “The Intelligent Investor” and after all who would not want that title applied to themselves.

Within the various theories on investing two major theories stand out in contrast to each other. Those who follow the Efficient Market theory and those who side with the Value Investing theory.

Well, if you are inclined to side with Graham and Buffet this volatility presents a chance to seek out some value investing opportunities. Therefore, keeping Buffet’s famous quote “when others are greedy I’m fearful and when others are fearful I’m greedy” in mind, this is a time to buy. But finding value requires analysis and this challenge is not helped when faced with the multiple options that exist for establishing the correct share price of any company.

The former claim markets are so efficient that stock prices reflect all known information and therefore the current price of any stock is always correct at that moment and only new information can or should cause prices to rise or fall. The latter believe that outside factors sometimes cause stock prices to move away from their real value but that this is temporary. Therefore, buying them at a discount equals value as the stock will ultimately revert to its correct price delivering a return to the investor.

The most famous follower of the principles put forward in the book includes Grahams one time student Warren Buffet regarded as the most successful investor ever.

The former claim markets are so efficient that stock prices reflect all known information and therefore the current price of any stock is always correct at that moment and only new information can or should cause prices to rise or fall. The latter believe that outside factors sometimes cause stock prices to move away from their real value but that this is

temporary. Therefore, buying them at a discount equals value as the stock will ultimately revert to its correct price delivering a return to the investor.

Do you use price to book value which measures the value of a company’s assets and compares

The MCSI World stock index is down 9.1% at the time of writing. January saw declines primarily linked to the American Federal Reserves faster than expected stance on raising interest rates this year to combat US inflation. February has seen a further decline linked to the Russian invasion of Ukraine.

So what does all this mean?

“However, if you side with the efficient market theory and everything is priced correctly now is a time to hold or maybe even sell depending on when you bought into the various markets. No one would ever like to crystallise a loss but there is no shame in taking a little less profit if this theory is right”

Cash Flow Modelling

Forecasting

S&P Return on $1,000 Invested Jan 1970 - March 2020

What do you do?

them to the stock price? In highlevel terms if the price is lower than the value of the assets, the stock is undervalued assuming the company is not in financial hardship. Perhaps you use the Price/Earnings ratio which shows the company’s track record for earnings to determine if the stock price is not reflecting all of the earnings or is undervalued. Others prefer Free Cash Flow to determine value, in other words the cash remaining after all operating expenses and capital expenditure have been paid. The money left over can be invested in the future of the business, pay off debt, pay dividends to shareholders or issue share buybacks.

Looking at the chart below of the S&P 500 over 50 years you will see the impact of being out of the market in volatile times and missing the ‘best days’ which often come after the worst days. What do you do?

• Since 1980, European equities have finished the year in positive territory on 31 of 40 years, yet in each of those years, the market suffered an average intra-year decline of 15.2%.

Stay disciplined. Although it may be uncomfortable at times, staying the course and sticking to your strategic financial plan could better serve you in achieving your long-term financial goals.

• By missing just the best 10 days in the market from 2003 to 2017, your investment returns would have been 48% lower.

interest rates and inflation as the future value of those earnings is adjusted to reflect the decrease in real terms of their present-day value on the balance sheet. Time silently erodes the purchasing power of savings and earnings alike. Therefore, companies whose business models are all about future earnings potential and not so much about current earnings will be impacted more negatively by interest rate increases. Hence the disproportionate drop in tech stocks this year.

Stay disciplined. Although it may be uncomfortable at times, staying the course and sticking to your strategic financial plan could better serve you in achieving your long-term financial goals.

• Keeping your money in cash is not the long-term answer as cash returns remain at record lows.

• Equities tend to recover strongly after large falls.

• Half of the top 10% days for market gains historically have happened in Bear Markets, so switching your funds after they fall could lead to you missing these upswings.

• Bear(falling) markets tend to be shorter than Bull Markets.

Some or all of these methods sit at the heart of the value investor philosophy, volatility creates value and analysis reveals value. All in all, it seems like a job best left to expert fund managers.

• Markets rise and fall daily, weekly, monthly – it is part of the natural cycle of investing. But historically, each significant market downturn has been followed by an eventual upswing.

• By missing just the best 10 days in the market from 2003 to 2017, your investment returns would have been 48% lower.

Diversify, Diversify, Diversify

• In the U.S., Monday March 23rd 2020 saw the third-best one-day gain for equities since 1945 for the S&P 500 after the two-day rebounds that followed the Black Monday Crash of 1987, and the Lehman Brothers bankruptcy in 2008.

• Despite the infamous ‘Black Monday’ of 1987, it was still a positive year for equities.

• Half of the top 10% days for market gains historically have happened in Bear Markets, so switching your funds after they fall could lead to you missing these upswings.

• Despite the last Bull Market being one of the longest on record, we still saw double-digit falls in 8 of the 11 years.

However, if you side with the efficient market theory and everything is priced correctly now is a time to hold or maybe even sell depending on when you bought into the various markets. No one would ever like to crystallise a loss but there is no shame in taking a little less profit if this theory is right. The truth is perhaps somewhere in between, not all stocks are the same and not all companies have current valuations anywhere near the tried and tested methods of valuing stocks.

For those of you with monthly pension contributions, the current volatility should not be a concern. Monthly contributions benefit from a concept known as Euro Cost averaging which means that each month your cash contribution buys units in your selected funds. So, if the price of these funds falls you buy more units that month which over time has the impact of giving you an average price per unit bought smoothing out shortterm volatility.

• Since 1980, European equities have finished the year in positive territory on 31 of 40 years, yet in each of those years, the market suffered an average intra-year decline of 15.2%.

• Markets rise and fall daily, weekly, monthly – it is part of the natural cycle of investing. But historically, each significant market downturn has been followed by an eventual upswing.

A basic tenet of investing is diversification. This means spreading risk by mixing a range of asset classes within your portfolio. A well-diversified portfolio might include equities, bonds, alternatives, property, and cash and helps smooth the return over the long run. While there is no such thing as a 100% riskfree investment, diversification can mitigate the inherent risk of investing, helping you to reach your long-term financial goals.

• Keeping your money in cash is not the long-term answer as cash returns remain at record lows.

• Equities tend to recover strongly after large falls.

• Bear(falling) markets tend to be shorter than Bull Markets.

Diversify, Diversify, Diversify

Anyone who is investing money whether it be through a pension fund, personally or with company funds should understand why markets react and sometimes overreact to events. The key to this is to understand what it means for your portfolio and how you can benefit from the active management of your funds during volatile markets.

Staying the Course

• In the U.S., Monday March 23rd 2020 saw the third-best one-day gain for equities since 1945 for the S&P 500 after the two-day rebounds that followed the Black Monday Crash of 1987, and the Lehman Brothers bankruptcy in 2008.

• Despite the infamous ‘Black Monday’ of 1987, it was still a positive year for equities.

Companies whose valuations are based primarily on future earnings like many tech stocks will be more adversely affected by rising

The instinct in volatile times is to move to safety, however, those who go into cash and bonds in these times will incur worse fund performance over the long term.

• Despite the last Bull Market being one of the longest on record, we still saw double-digit falls in 8 of the 11 years.

As is so often true in life seek out those who are expert enough to advise you well. The harsh truth is that not all fund managers are created alike and yours may not be top tier. This is true with Irish pension fund managers. The difference between the best and worst in class is stark. It is always worth getting a review of your investment strategy especially when markets are volatile, who knows, value may just be lurking out there.

A basic tenet of investing is diversification. This means spreading risk by mixing a range of asset classes within your portfolio. A well-diversified portfolio might include equities, bonds, alternatives, property, and cash and helps smooth the return over the long run. While there is no such thing as a 100% riskfree investment, diversification can mitigate the inherent risk of investing, helping you to reach your long-term financial goals.

As is so often true in life seek out those who are expert enough to advise you well. The harsh truth is

Lack of Micronutrients Linked to Inflammation

Irritable bowel diseases – or IBD – including such diseases as Crohn’s disease and ulcerative colitis, are relapsing bouts of bowel inflammation that can trigger a number of highly unpleasant symptoms.

Significantly lower levels of antioxidants

The study, which is published in Digestive Diseases and Sciences in June 2021, includes 98 patients with Crohn’s disease, 118 patients with ulcerative colitis, and 43 healthy controls without any of these conditions.

By comparing disease prevalence and micronutrient status, the researchers could clearly see how levels of the two antioxidants were significantly lower in patients with IBD, especially those patients suffering from Crohn’s disease.

Vital for the body’s inflammation defense

Both selenium and zinc are involved in a host of different biological processes that are related to inflammation. Selenium

is needed for normal functioning of some selenium-dependent enzymes called selenoproteins, of which there are around 25-30 in the human body. Two of these selenoproteins, selenoproteins S and selenoprotein K, have a role in dialing down inflammatory signaling pathways. In other words, selenium supports selenoproteins that have a proven inflammatory effect.

Zinc also plays a vital role. This is clearly demonstrated by the fact that zinc deficiency increases the number of pro-inflammatory cells and promotes intestinal leakage of certain inflammatory cytokines (white blood cells) that are known to worsen inflammation in the intestinal area.

It is therefore essential for people with bowel inflammation to make sure to get sufficient quantities of

selenium and zinc, as this helps control their symptoms.

The problem is that irritable bowel diseases negatively affect the absorption of micronutrients from food, as the inflammation has a harmful impact on the intestinal mucosa.

Therefore, IBD sufferers have difficulty with getting the muchneeded nutrients into the bloodstream, simply because the mechanisms that allow micronutrients to pass through the intestinal membrane are flawed. Supplementation with selenium and zinc appears to be a rather obvious solution, as this is an easy way to access therapeutic doses of both nutrients.

Besides a protective role in inflammatory bowel disorders,

selenium and zinc have been shown to have a prophylactic effect on colorectal adenomas, which are benign tumor growths that can potentially develop into bowel cancer if left untreated.

In a randomized controlled Italian study2 that was published in the Journal of Gastroenterology in 2013, supplementation with selenium and zinc plus vitamins A, B6, C, and E was shown to significantly reduce recurrence of adenomas in the large bowel in patients who had undergone surgical removal of adenomas prior to supplementation.

Sources:

Digestive Diseases and Sciences, June 2021 (doi: 10.1007/s10620021-07078-z)

Journal of Gastroenterology, 2013 Jun;48(6):698-705.

Paediatric Diabetes – Advice for Pharmacists

Why do children get diabetes?

More than 95% of diabetes diagnosed in childhood in Ireland is caused by Type 1 Diabetes (T1D), an autoimmune condition resulting in destruction of the individual’s own pancreatic beta cells which leads to absolute insulin deficiency. Similar to other developed countries, the incidence of this condition is rising, particularly in Ireland in the age group 10-14 years old. Individuals are born with a genetic susceptibility to developing T1D, which is then triggered by an inductive environmental event, currently thought to be viral infection e.g. enterovirus, acting to induce autoimmunity via molecular mimicry. Post-diagnosis, individuals with T1D are dependent on insulin replacement therapy for life. It is worth stating that children with T1D did not acquire this as a result of diet or sedentary lifestyle, which is a negative misconception in the lay world that affects them, resulting from confusion with Type 2 Diabetes pathophysiology. Cases of T2D do occur, usually in the post-pubertal age group but not at rates seen in the USA and other countries.

Most notably, 2022 is an important year in the diabetes world, marking the 100 year anniversary of the development of exogenous insulin therapy in Canada by Frederick Banting and Charles Best. Prior to their Nobel prize-winning achievement, all children who developed T1D died, usually within 6-12 months of diagnosis. On the 11th January 1922, Leonard Thompson, a 14-year old boy dying from diabetes in a Toronto hospital, became the first person to receive an insulin injection. Within 24 hours his hyperglycaemia resolved and he lived for another 13 years, eventually dying of complications of pneumonia aged 27.

How does diabetes present in children?

Without sufficient insulin to facilitate intracellular carbohydrate metabolism, glucose

becomes trapped in the person’s bloodstream, which the body attempts to compensate for via renal excretion of glucose. This results in the classic symptoms of clinical diabetes, these being excessive urination, which in turn leads to excessive thirst and weight loss. Without carbohydrate metabolism, cells shift to fatty acid oxidation to generate energy, but manufacture ketones as a by-product. These acidic molecules cause a characteristic sweetsmell from the breath, a flushed complexion and abdominal pain, the latter of which can be very severe. Early symptoms can be subtle and the increased fluid consumption can be mistaken for comfort drinking, especially if a child has just started pre-school or school, or can also be easily misinterpreted during warmer months of the year. The earlier symptoms are recognised and treatment is initiated the better, however approximately 40% of children at diagnosis are in Diabetic Ketoacidosis (DKA), a life-threatening consequence of deteriorating hyperglycaemia which, if left untreated, can result in coma and death. The proportion of newly-diagnosed children in DKA was higher during the past 2 years across the world, due to a combination of inability and reluctance to access healthcare during lockdowns. Compensation for the severe acidosis can result in deep, sighing breathing which has unfortunately been misinterpreted as consistent with acute COVID-19 infection, particularly with resort to telephone consultations during the pandemic. Public education campaigns in countries such as Italy have assisted earlier diagnosis and DKA prevention. Given that Ireland is designated an area of high incidence of T1D in children and adolescents, it is important that all Irish healthcare professionals including community pharmacists be aware of the symptoms of new onset diabetes.

How is diabetes in children treated?

Once diabetes is diagnosed and a child’s condition is stabilised, treatment commences immediately with insulin replacement therapy. The overarching goal of modern diabetes care is the maintenance of blood glucose levels as close to ‘target’ as possible, using the philosophy of an intensive insulin regimen, balanced with the psychosocial effect of this on the child, parents/carers and wider family. Target blood glucose levels are individualised, but generally in the range of between 4 and 8 mmol/L before a meal and 4 and 10 mmol/L post-prandially. A paradigm shift occurred in diabetes care in 1993 with publication of the Diabetes Control and Complications Trial, a multicentre randomised controlled trial which definitively showed that exposure to hyperglycaemia was directly linked in a dose-response manner to the development of diabetes-related complications; these being micro-vascular disease in the form of retinopathy, nephropathy and neuropathy and macro-vascular disease in the form of stroke and heart attacks. Follow-on studies of

this and other diabetes cohorts, such as the EDIC trial, showed that the benefits of tight blood glucose control were maintained for decades afterwards, with persistent reduction in macro-vascular disease of 57% after 17 years and rate of onset of diabetic retinopathy still 62% lower in the original intensively treated group after 7 years. These findings are persistent in all causes of hyperglycaemia, either from Type 1 or Type 2 diabetes. Diabetic retinopathy is currently the leading cause of acquired blindness in the developed world. The primary measure of glycaemic control in these trials was Glycosylated Haemoglobin, or HbA1c, which subsequently has been used to benchmark glycaemic control and is often available in diabetes out-patient clinics as a point-of-care test. Paediatric targets for HbA1c were recently lowered to 7% (53 mmol/mol) by both the International Society for Paediatric and Adolescent Diabetes (ISPAD) and agreed by the Irish Diabetes Expert Advisory Group. Again, young people may have differing individual targets agreed with their paediatric care team. The economic consequences of diabetes and its related complications are enormous, with 784 million people worldwide predicted to be diagnosed with diabetes by 2045 and, in the US alone, contributing $237 billion in direct medical costs per year, or 7% of the nation’s health care budget which is higher than that spent on cancer (5%) or heart disease/stroke (4%).

Post-diagnosis, children and their parents/ carers will often spend up to a week learning the basics of diabetes care, in order to function safely after discharge. The majority of children in Ireland commence a multiple daily injection (MDI) regime, consisting of short-acting insulin before each main meal (usually breakfast, lunch and dinner), with a long-acting insulin usually delivered in the evening. Doses of insulin are calculated according to anticipated carbohydrate intake, exercise and self-monitored blood glucose levels. The variety of insulin analogs available has increased significantly in recent years, along with a significant exponential increase in technologies available, the latter of which are successful in reducing painful injection and finger-pricking burden. Short-acting insulins commonly used include Aspart and Lispro (Novorapid©, Fiasp©, Humalog©) with long-acting options such as Glargine, Detemir, and Degludec (Lantus©, Levemir©, Tresiba©). Insulin regimens are chosen that minimise episodes of hypoglycaemia, mitigate hyperglycaemic excursions and are feasible for the family and young person to administer. Some young people may be on more bespoke regimens using more medium or intermediate insulins and some may be using premixed insulins, although this proportion is lessening. Adolescence is often a particularly challenging time for adherence to the prescribed insulin regimen, along with being a period of endogenous higher insulin resistance secondary to pubertal hormones.

Teething problems post-diagnosis

After discharge from hospital, young people and their families are supported by hospital-based multidisciplinary teams to incorporate diabetes into their daily lives, learning how to titrate insulin to glycaemic pattern, troubleshoot early issues and manage particular scenarios such as illness, exercise and sports whilst managing burgeoning independence with ongoing education on selfmanagement for events such as sleepovers, self-administration of insulin etc. Since the inception of the national Model of Care in 2015, paediatric diabetes care is organised into integrated practice units comprising a regional centre of reference and a number of additional local units, organised in a hub and spoke model. The majority of units conduct initial support by telephone, with some centres having space to facilitate a ‘drop-in’ support service and some using more telehealth methods, use of the latter being accelerated by the pandemic.

In the first month after diagnosis, patients are educated to anticipate the temporary ‘honeymoon period’. At time of presentation of clinical diabetes, approximately 10-15% of the original beta cell mass is estimated to remain functional. Provision of exogenous insulin allows the beta cells some reprieve and allows them to re-establish intracellular stores of insulin, necessitating a reduction in dose of injected insulin and sometimes a partial remission. This is commoner in children aged >5 years old, those not in DKA at diagnosis and lasts on average 6 to 12 months, as continued immunological destruction of the remaining beta cells does continue. Repeated episodes of hypoglycaemia are common as the dose of insulin is reduced and it is necessary to have extra hypoglycaemia supplies available at this time for prompt treatment. Messages around hypoglycaemia management are important and must be consistent. Hypoglycaemia is generally defined as a blood glucose level of <4 mmol/L and mild/moderate versus severe is not quantified by number, but according to the symptoms displayed by the individual. Severe hypoglycaemia is defined as an episode which results in either loss of consciousness or the individual needing another person’s assistance to manage their hypoglycaemic episode. Injectable glucagon is available and should be carried by all people with T1D for this instance, especially those with impaired hypoglycaemia awareness such as younger children. More common are episodes of mild to moderate hypoglycaemia, with symptoms such as pallor, tremor, increased sweating and tachycardia, progressing to confusion and impairment of consciousness without treatment. Treatment consists of 0.3g/kg of a fast-acting glucose source such as Lucozade©, Dextrose tabs, Glucogel©, or Lift© (formerly known as Glucojuice). Options such as chocolate, milk or biscuits are inappropriate treatment options for hypoglycaemia as their fat content renders their absorption too slow. Introduction of the sugar tax in 2017 caused reformulation of many soft drinks, generally meaning that much more volume of the liquid is now required for adequate hypo treatment. This can be difficult for younger children in particular, hence ‘Lift©’ with 15g per 60ml is an option growing in popularity and available on the long term illness scheme.

Other early issues include needle incompatibility with resultant leakage of insulin and hyperglycaemia and/or ketosis. In general, most insulin products will be compatible with needles made by the

same company and generic substitutions have resulted in administration issues. The recommended needle length for most children is 4 to 5 mm and site rotation is of utmost importance to avoid erratic absorption from lipohypertrophy. If in any doubt, please do not hesitate to liaise with the paediatric diabetes team who will be more than happy to advise.

Diabetes-related Technologies

The past decade has seen an explosion in technologies, particularly insulin pumps (continuous subcutaneous insulin infusion, or CSII) and continuous glucose monitors (CGM). Insulin pumps are an alternate method of ‘intensive treatment’ of diabetes which consist of a small pager-sized device worn by the young person on a belt, Velcro pouch or waistband. The family fill insulin into a reservoir in the device which is then infused continuously at pre-set basal rates via a short line and subcutaneous access site to the subcutaneous space. User-activated boluses are administered for food and correction when blood glucose is high, with most devices containing calculators to assist the maths of bolus calculation. Basal rates can be adjusted to account for illness, menstruation or increased activity, increasing flexibility and often improving quality of life for those engaged in their use. Our National Model of Care prioritises insulin pump access for those aged <6 years old, reflecting their increased need given their tendency to hypoglycaemia unawareness, reduced ability to articulate hypoglycaemia symptoms, erratic eating patterns, susceptibility to viral intercurrent illness and requirement for smaller insulin increments. Pump training and initiation is resource heavy, requiring high investment of time for training and support afterwards on the part of both the family and the multidisciplinary team. Fortunately in Ireland, no co-payments are needed and this equipment is funded by our health care system, unlike other first world countries where access to insulin and pumps is not universal.

CGM devices have revolutionised glucose monitoring, previously challenging due to the painful nature of the capillary fingerpricks and disadvantaged as representing an isolated snapshot of glucose control. These devices are placed in the subcutaneous space of the young person using an automatic inserter device and consist of a sensor to estimate

interstitial glucose, along with a transmitter which sends the reading to a mobile phone, insulin pump or other receiver device. Hypo or hyperglycaemia alarms assist detection and some devices allow caregivers to follow glucose levels remotely from their own mobile phones. They generally assess glucose levels at intervals of 5 minutes, either continuously relaying this information to the receiver (Medtronic Guardian© or Dexcom G6©), or intermittently when a user ‘flashes’ the receiver to read the sensor when indicated (Abbott Freestyle Libre©). The decision as to which device would be suitable to which patient is reached collaboratively by the family and their health care team. Disadvantages include skin hypersensitivity to the adhesive, exacerbation of underlying anxiety by alarms, perceived inaccuracy (interstitial sensed versus true blood glucose) and sensors falling off with activity. Diabetes teams are well versed in troubleshooting these issues and should be consulted in order to maximise the benefit for the child of these expensive systems. These CGM systems are currently funded for the paediatric population and an active campaign is underway nationally to extend eligibility to those aged over 21 with T1D.

The ‘holy grail’ of diabetes technologies is the interaction of blood glucose information from CGM with insulin delivery with CSII through a functioning algorithm to allow autonomous insulin delivery without user interaction, a.k.a the ‘closed loop’, or artificial pancreas system. In 2022 two systems with partial closed loop are available in Ireland which adjust basal insulin delivery only. User input is still required for bolus insulin delivery but advancements continue apace in this area.

Conclusion

T1D is a chronic burdensome illness of childhood which affects quality of life for the young person and their family and is associated with significant complications. Specialist paediatric teams deliver increasingly specialist technological advances to our vulnerable population and encourage proactive management strategies to maximise glycaemic control. Community pharmacies are integral to delivery of this care and an active relationship with patients and their teams is encouraged.

Next month’s issue of IPN will carry a followon article looking at the LTI and resources.

HEALTH AND SAFETY EXECUTIVE (HSE) APPROVES ADTRALZA®

LEO Pharma welcomes the news that the Health Service Executive (HSE) has approved tralokinumab for reimbursement in Ireland via the High-Tech Scheme.3 This approval makes tralokinumab the first reimbursed biologic that specifically targets the IL-13 cytokine alone, a driver of atopic dermatitis signs and symptoms, for use within Ireland.1,2,3

Tralokinumab is the first high affinity, human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine in adult patients with uncontrolled moderate-tosevere atopic dermatitis who are candidates for systemic therapy.1,2

Tralokinumab is available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week.7

Tralokinumab can be used with or without topical corticosteroids (TCS).7

“I am delighted that patients with moderate-to-severe Atopic Dermatitis in Ireland will now have access to tralokinumab, an important new treatment option for these patients. Atopic Dermatitis is much more than a skin condition, it can have a profound effect on the emotional and psychological wellbeing of patients, as well as on their physical health,” said Professor Alan Irvine, Consultant Dermatologist, School of Medicine Trinity College Dublin.

The evidence supporting the efficacy and safety of tralokinumab comes from four randomised, multicentre, doubleblind, placebo-controlled, phase III studies: ECZTRA 1, ECZTRA 2, ECZTRA 3 in patients with moderate-to-severe atopic dermatitis and ECZTRA 7 in patients with severe disease.4,5,6

Tralokinumab was approved by the European Commission (EC) for adults with moderate-tosevere atopic dermatitis who are candidates for systemic therapy in Europe and by the Medicines & Healthcare products Regulatory Agency (MHRA) in Great Britain, in June 2021. The MHRA and EC decisions are valid in the UK and all European Union Member States, Iceland, Norway, and Liechtenstein. Tralokinumab is also approved for use in Canada, the United Arab Emirates and was approved by the U.S. Food and Drug Administration (FDA) on the 27th December 2021.

References on request

SPRAVATO® (ESKETAMINE)

NASAL SPRAY APPROVED

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that SPRAVATO® (esketamine) nasal spray has been granted reimbursement in Ireland for the treatment of adults living with treatment-resistant major depressive disorder (TRD), in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI). People are considered to have TRD if they have not responded to at least two different treatments with antidepressants in the current moderate-to-severe depressive episode.1

Ireland has one of the highest rates of mental illness in Europe and it is estimated that approximately 150,000 people per year are living with severe depression (also known as Major Depressive Disorder or MDD) here.2,3 Major Depressive Disorder (MDD), the underlying disorder associated with Treatment Resistant Depression (TRD), is a severely debilitating psychiatric disorder. For these patients, the main goal of treatment is to relieve the symptoms of depression, and ultimately achieve remission,

ACCORD HEALTHCARE LAUNCH ICATIBANT ACCORD 30 MG SOLUTION FOR INJECTION IN 3 ML PRE-FILLED SYRINGE

Accord Healthcare is delighted to announce the launch of another High-Tech medicine to their already extensive portfolio of High-Tech medicines: Icatibant Accord 30 mg which comes in a pack of one 3 ml pre-filled syringe.

This medicine is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.

Please refer to the Summary of Product Characteristics (SPC) for further information. The SPC will be available from the launch date at www. hpra.ie and for Healthcare Professionals at www.accord-healthcare.ie.

Icatibant Accord will be available from both full-line wholesalers from launch. For further information please contact Accord in Cork on 021461 9040 or visit www.accord-healthcare.ie

Think High-Techs, Think Accord

with few, if any, symptoms of depression remaining.4 However, about one third of people with MDD do not respond to currently available treatments.5

The approval of esketamine is based on data from a clinical trial programme in patients with TRD, including over 1,600 patients treated with esketamine. The five Phase 3 trials included three shortterm studies, one randomised withdrawal and maintenance of effect study, and one long-term safety study.6,7,8,9,10* These data demonstrated that treatment with esketamine nasal spray plus a newly initiated oral antidepressant was associated with a greater reduction in depressive symptoms compared to a newly initiated oral antidepressant plus placebo nasal spray, in adult patients (18-64 years), with the onset of efficacy as early as Day 2.6

Approximately 70 percent of esketamine-treated patients responded to treatment, with a ≥50 percent symptom reduction. Furthermore, approximately half of all treated patients achieved remission at the end of the 4 week studies.1 Continued treatment with esketamine nasal spray plus oral antidepressant reduced the risk of relapse by 70 percent among patients with stable response and by 51 percent in patients in stable remission, compared to continuing treatment with oral antidepressant alone.9

The decision to prescribe esketamine should be determined by a psychiatrist.1 Esketamine is intended to be self-administered by the patient under the direct supervision of a healthcare professional.1 A treatment session consists of nasal administration of esketamine and a postadministration observation period. Both administration and post -administration observation of esketamine should be carried out in the appropriate clinical setting.1

Further prescribing information can be found at https://www. medicines.ie/medicines/ spravato-28-mg-nasal-spraysolution-35070/spc

References on request

BAYER’S NEW TREATMENT KERENDIA® (FINERENONE) APPROVED IN EU

The European Commission has granted marketing authorization in the European Union (EU) for finerenone under the brand name Kerendia®. Kerendia® (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist, is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

Finerenone is different to existing CKD in T2D treatments. It acts by blocking mineralocorticoid receptor (MR) overactivation, which is thought to contribute to CKD progression and cardiovascular damage.

“The worrying reality is that chronic kidney disease in type 2 diabetes is the leading cause of end-stage kidney disease, which ultimately means that the kidneys no longer support the body’s needs and patients need dialysis or a kidney transplant to stay alive. Early intervention is associated with a better prognosis, and it is key to prevent further end-organ damage by reducing the risk of kidney function loss,” said Dr. Michael Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance at Bayer’s Pharmaceuticals Division.“The approval of Kerendia offers physicians a new path to protect these vulnerable patients by reducing their risk of cardiovascular events and delaying kidney disease progression.”

The approval of Kerendia in the EU is based on the results of the pivotal Phase III FIDELIO-

DKD study, presented at the American Society of Nephrology’s (ASN) Kidney Week 2020 and simultaneously published in the New England Journal of Medicine (NEJM) in October 2020.

In July 2021, Kerendia was approved by the U.S. Food and Drug Administration (FDA) based on the positive results of the FIDELIO-DKD Phase III study. In December 2021, Kerendia received a Grade A recommendation in the new treatment guidelines of the American Diabetes Association (ADA), “Standards of Medical Care in Diabetes 2022” for the treatment of patients with CKD and T2D who are at increased risk for cardiovascular events or CKD progression or are unable to use a sodium-glucose cotransporter 2 inhibitor.

Finerenone has also been submitted for marketing authorization in multiple other countries worldwide and these are currently under review.

LENALIDOMIDE CLONMEL

Clonmel Healthcare is delighted to announce the launch of Lenalidomide Clonmel 5mg, 10mg, 15mg, 20mg, 25mg hard capsules.

Lenalidomide Clonmel is indicated for the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma.

Lenalidomide is structurally related to thalidomide, which is a known human teratogen that causes severe life-threatening birth defects. An unborn child is likely to be

harmed if exposed to lenalidomide during pregnancy, therefore a pregnancy prevention programme (PPP) is in place for all lenalidomide products and applies to all patients prescribed lenalidomide.

In order to support HCPs in fulfilling the requirements of the lenalidomide PPP, Clonmel Healthcare in collaboration with a number of other Marketing Authorisations Holders, has created an online platform called the Patient Safety Hub (PSH) which may be used by prescribers and pharmacies. It is available at www.patientsafetyhub.ie.

Pharmacies wishing to purchase and dispense Lenalidomide Clonmel must register via the Patient Safety Hub at www.patientsafetyhub.ie.

Registration involves the pharmacy indicating its agreement and compliance with the requirements of the lenalidomide pregnancy prevention programme. A user guide and training videos on use of the PSH are also available to access via the hub.

Full prescribing information is available on request or alternatively please go to www.clonmel-health.ie.

Medicinal product subject to medical prescription.

Please contact Clonmel Healthcare on 01-6204000 if you require any additional information.

PA 126/320/002, 004-007. PA Holder: Clonmel Healthcare Ltd., Clonmel, Co. Tipperary. Date prepared: February 2022. 2022/ ADV/LEN/031H.

NEW – GLUCORX AIDEX - CONTINUOUS GLUCOSE MONITOR

EC MSRKETING AUTHORISATION FOR JARDIANCE®

Empagliflozin (Jardiance®) has been granted a marketing authorisation by the European Commission (EC) for the treatment of adults with symptomatic chronic heart failure.[i] With this latest approval, empagliflozin becomes the first and only clinically proven treatment that can significantly improve outcomes for adults across the full spectrum of symptomatic chronic heart failure, which includes heart failure with preserved ejection fraction (HFpEF).

What does this new approval mean for the heart failure clinical landscape?

• Until now, there were no approved and clinically effective treatments that address all forms of heart failure, including HFpEF, which has previously been described as the single largest unmet need in cardiovascular medicine.[i],[ii]

• Heart failure is one of the leading causes of avoidable hospitalisations, and readmissions to hospital among people with heart failure leads to poor survival.[iii],[iv],[v]

• Marketing authorisation was granted based on data from the landmark EMPEROR-Preserved Phase III clinical trial, the first of its kind to significantly show a relative reduction in the composite primary endpoint of cardiovascular death or hospitalisation for heart failure with empagliflozin, compared to placebo, on top of standard of care in patients with HFpEF.[vi]

• This marketing authorisation is valid in all EU member states, including the Republic of Ireland.

Neil Johnson, CEO of Croí, Irish patient organisation fighting against heart disease and stroke, and Executive Director of the Global Heart Hub says, “It’s estimated that over 60 million people worldwide are living with heart failure. This complex medical condition very often has a devastating impact on quality of life: physically, emotionally and even financially for those who can no longer work. New treatments for a heretofore underserved population of patients which can improve outcomes and reduce hospital admissions is just great news for patients. The impact of new and emerging treatments on quality of life, from a patient and carer perspective, cannot be overstated because they provide hope and comfort in the knowledge that heart failure can be treated. This in turn has an enormously positive impact on overall mental health and wellbeing by decreasing anxiety, stress and worry.”

The UK authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) is anticipated to follow in the coming months. Do let us know if the MHRA announcement will be of interest to cover, as we will have a suite of interview slots available including: people living with heart failure, patient group representatives, healthcare professionals working in the field and a spokesperson from Boehringer Ingelheim.

References on request

Windzor Pharma are delighted to announce the launch of GlucoRX Aidex to the Irish Market. Aidex is a continuous Glucose Monitor available for all patient types.

The sensors are small and secure and can be used on the arm or the abdomen. Each transmitter has a lifespan of 3 years and each sensor lasts up to 14 days. All data is submitted from the sensor to the GlucoRx Aidex app making it easy to track your glucose levels during the day. For more information, training or to order please contact orders@windzorpharma.com

Transmitters and sensors are available through UDW and Uniphar and PCO. Sensor GMS code 85241