IPN 2020 October

October 2020 Volume 12  Issue 10 PHARMACYNEWSIRELAND.COM

THE INDEPENDENT VOICE OF PHARMACY

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In this issue:

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NEWS: Paul Reid announced as new President for IPHA Page 7

ACQUISITION: Uniphar agreement with Hickey’s Page 12

REPORT: Biosimilars in Community Pharmacy Page 20

FEATURE: Flu Vaccinations more important than ever Page 28

CPD: Management of Eye Conditions Page 39

TEAM TRAINING: Managing Migraine Page 52

Join Ireland’s Newest Buying Platform www.indegoplus.ie See pages 50 & 51 to find out more

EDUCATIONAL: Osteoporosis and Menopause Page 66

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Contents

Foreword

Page 7: Is pharmacy a sector in crisis?

In our lead news this month, it was announced that pharmacy supply group Uniphar has agreed to buy the 36 strong Hickeys chain. Uniphar already has 299 pharmacy shops across the country under the Allcare and Life Pharmacy Symbol Group brands.

Page 8: Diabetes innovation success for Garvan Lynch Page 13: Generic and biosimilar medicines set to free up ¤1bn Page 14: FIP sets new Pharmacy Development Goals

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At the same time Uniphar is also adding significant additional wholesale capacity with a new facility in development at Annacotty in Limerick due to come on stream later this year.

Page 16: United Drug partner up with Aware

The deal was announced alongside Uniphar financial results for the first half of the year. The results show trading broadly in line with expectations.

Page 20: Biosimilars and the role of Pharmacy Page 24: Winter flu vaccinations more important than ever

Revenue rose ¤71m to ¤871m and gross profit was up 23pc to ¤102m. The group continues to expect a ¤5m impact from Covid-19 this year.

20

The announcement highlights the unsustainable financial pressures on the community pharmacy sector, according to the Irish Pharmacy Union (IPU).

24

MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com

CONTRIBUTORS Jacqui Murray | Rob Wood Niamh Cahill | Colm Moore Rachel Dungan Stuart Fitzgerald DESIGN DIRECTOR Ian Stoddart Design PHARMACYNEWSIRELAND.COM @Irish_PharmNews IrishPharmacyNews

Recent research by the IPU found that it is costing the pharmacy sector over ¤10 million a month to remain open and to provide safe care. In addition, pharmacies have reported retail sales falling by an average of 36% since the start of the crisis. One in five pharmacies has laid off staff, while another two in five (38%) indicated they would have to do so over the next few months.

Elsewhere, this issue carries a plethora of on-topic features and news stories, including extensive content on preparing both your pharmacy and your customers for what has been forecasted to be an extremely harsh winter. Flu vaccinations are now underway, with demand outstripping supply in some cases.

EDITOR Kelly Jo Eastwood: 00353 (87)737 6308 kelly-jo@ipn.ie ADVERTISING EXECUTIVE Amy Evans: amy@ipn.ie

Turn to page 12 for full and exclusive details on the deal.

In other news, it was revealed that The High Court has appointed an interim examiner to the Cara Pharmacy Group, which employs over 160 people. The application for the examiner's appointment was sought by Elm Corporate Credit DAC, which is the group's lender and is its largest creditor.

Page 48: Barry O’Sullivan on the transition from community to hospital pharmacy PUBLISHER: IPN Communications Ireland Ltd. Clifton House, Fitzwilliam Street Lower, Dublin 2 00353 (01) 6690562

Hickeys is the fifth biggest independent chain in Ireland with shops in Dublin (21), Cork, Meath, Louth, Kildare and Wexford, which will continue to trade under the Hickeys brand if the deal closes. The acquisition is subject to approval by the Competition and Consumer Protection Commission.

48 Irish Pharmacy IRISH News is PHARMACY circulated to all NEWS independent, multiple Pharmacists and academics in Ireland.

All rights reserved by Irish Pharmacy News. All material published in Irish Pharmacy News is copyright and no part of this magazine may be reproduced, stored in a retrieval system or transmitted in any form without written permission.

IPN Communications Ltd. has taken every care in compiling the magazine to ensure that it is correct at the time of going to press, however the publishers assume no responsibility for any effects from omissions or errors.

Peter Conroy gives readers an insight into boosting the immune system on page 35, whilst Rob Wood looks at nutrition in children.

Our Special Report focuses on the biosimilars market and the role community pharmacy may play.

Enjoy the issue.

Regulars CPD: MANAGEMENT OF EYE CONDITIONS FEATURE: EAR CARE TEAM TRAINING: MIGRAINE FEATURE: NUTRITION IN CHILDREN BUSINESS CPD

P39 P44 P52 P63 P70

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6

News

New Appointment strong signal for Irish Medicines The appointment of Mairead McGuinness as EU Commissioner-designate for financial services and financial stability by EU Commission President Ursula Von Der Leyen is a very welcome development for the hugely important Irish medicines and pharmaceutical sector.

According to David Delaney, Chairperson of Medicines for Ireland, “the appointment of Mairead McGuinness to this hugely important role is very good news for the important medicines and pharmaceutical sector in Ireland.

“At Medicines for Ireland and through our parent organisation Medicines for Europe, we have engaged constructively with Mairead McGuinness throughout Mairead McGuinness, EU Commissioner-designate

her time as an MEP. What has been remarkable has been her ability to influence policy and resolve very technical issues.

“Medicines for Ireland has worked with Mairead McGuinness since 2016 on the complex issue of Brexit in the context of ensuring that patients in Ireland are not impacted with the movement of medicines into Ireland. This crucial preparatory work for a ‘no trade deal’ Brexit has proven invaluable to Ireland in the context of the global Covid-19 pandemic.”

Chemist Warehouse is Moving In Chemist Warehouse, an Australian discount pharmacy chain, is planning to enter the Irish market.

The retailer, which has been dubbed the McDonald’s of pharmacy, has linked up with an Irish pharmacy entrepreneur to establish a subsidiary here and is believed to have already lined up its first outlets in Dublin.

The company, controlled by the

Verrocchi and Gance families, has a network of more than 400 chemists across Australia.

It also has an online business, ePharmacy.

It is one of Australia’s largest retailers, with annual sales estimated at A$4bn (¤2.5bn), and a 26% share of the country’s retail pharmacy market.

World Pharmacists Day As designated in 2009 by the FIP Council in Istanbul, Turkey, 25 September marks the annual World Pharmacists Day. Pharmacists are encouraged to use this day to organise activities that promote and advocate for the role of the pharmacist in improving health in every corner of the world.

In associated news, Ireland’s own Darragh Connolly has just been appointed as Vice-President of FIP’s Community Pharmacy Services division.

This year sees the 10th World Pharmacists Day. The World Pharmacists Day theme this year is an opportunity to communicate how pharmacists are transforming health through a variety of health services in their communities, including advising on healthy living, vaccinating to prevent disease, and ensuring that medicines are taken correctly, thereby managing diseases well and improving quality of life.

Darragh Connolly, Vice-President, FIP, CPS

PHARMACYNEWSIRELAND.COM

Alcohol Medication Interactions The combined use of alcohol and medications cause more than one in four adults over the age of 65 to be vulnerable to potentially serious alcoholmedication interactions, which can lead to falls and other accidents, gastrointestinal bleeds and liver damage.

This is according to new research from the Royal College of Surgeons School of Pharmacy. Pharmacist and lecturer at RCSI School of Pharmacy and Biomolecular Sciences Dr Alice Holton says, “Our findings also suggest that older adults are at greatest risk of potentially serious alcoholmedication interactions due to their concurrent use of alcohol with cardiovascular agents, and with medications which act on the central nervous system.”

These alcohol-medication interactions can manifest in the form of increased sedation, leading to falls and other accidents, issues with blood sugar and blood pressure, gastrointestinal bleeds and liver damage.

The use of multiple medications also increases with age, indicating that older adults are particularly vulnerable to the harm caused by a combination of alcohol and medication in the body.

Researchers at RCSI sought to more accurately estimate the prevalence of those at greater risk of potentially harmful alcohol-medication interactions.

1,599 older adults living at home were studied by conducting face-to-face interviews which were linked to their drug dispensing records in their community pharmacies.

The study revealed that 67% of older adults drink alcohol, with 27% identified as heavy drinkers.

People were considered heavy drinkers if they reported drinking more than 6 standard drinks (60 grams alcohol) per drinking occasion or more than 11 standard drinks every week for women or 17 standard drinks per week for men. 28% of older adults (42% of those who drink) were identified as being at risk of potential harm from alcohol-medication interactions.

News Asthma Medicine Considerations The Asthma Society of Ireland has released their Pre-Budget Submission 2021, which presents to the Government five asks to be considered in the 2021 Budget that could greatly improve the lives of people with asthma in Ireland.

The Asthma Society is calling upon the Government for a subsidisation of all asthma medications outlined in steps 1 to 4 of GINA guidelines which categorise medications for the main treatment of asthma for those with mild to moderate asthma.

Currently 380,000 people in Ireland have asthma and 890,000 will develop the condition in their lifetime. It is estimated that more than half of people living with asthma do not have their disease under control, putting them at a higher risk of asthma attacks/exacerbations, hospitalisations, absence from school and work, and even dying due to their condition.

The five asks of the Asthma Society Pre-Budget Submission are:

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Pharmacy Sector in Crisis The announcement that the Cara Pharmacy Group has entered examinership highlights the unsustainable financial pressures on the community pharmacy sector, according to the Irish Pharmacy Union (IPU).

The pharmacy sector suffered deep cuts in funding imposed during the financial crisis a decade ago and which, despite repeated government commitments, have not been reversed. The increasing financial pressure has already resulted in a number of prominent pharmacy insolvencies, with several pharmacy businesses entering examinership or being taken over by their creditors or suppliers.

According to IPU Secretary General Darragh O’Loughlin, “Throughout the COVID-19 pandemic pharmacies have

kept their doors open to ensure the supply of medicine, and healthcare services have continued in every community across the country. However, staying open has come at a significant cost to those pharmacies. All of them had to invest significantly to put in place measures to keep staff and patients safe, putting huge pressure on pharmacy businesses. It is a worrying time for the staff of Cara Pharmacy Group and those across the sector. Unfortunately, many pharmacies have laid staff off,

and many more may be forced to do so.”

Recent research by the IPU found that it is costing the pharmacy sector over ¤10 million a month to remain open and to provide safe care. In addition, pharmacies have reported retail sales falling by an average of 36% since the start of the crisis. One in five pharmacies has laid off staff, while another two in five (38%) indicated they would have to do so over the next few months.

Turn to page 12 for a full report on this issue.

Paul Reid Named As New IPHA President Paul Reid, Pfizer Healthcare Ireland’s Managing Director, has been named President at the Irish Pharmaceutical Healthcare Association (IPHA), the representative body for the international originator biopharmaceutical industry.

Paul Reid, Managing Director, Pfizer Healthcare Ireland

1. Introduce universal full subsidisation of asthma medications 2. Expand national fund for severe asthma medication

Biogen’s Michael O’Connell has been confirmed as Vice-President.

3. Find the extension of the current asthma management programme for all people with asthma

Mr Reid takes over the role vacated by GSK’s Aidan Lynch after his two-year term.

4. Increase the number of registered Advanced Nurse Practitioners to meet 2% Department of Health guidelines 5. Provide the Asthma Society of Ireland with annual core funding Asthma is estimated to cost the State ¤472 million a year.

A Universal asthma selfmanagement programme could save the State between ¤68 and ¤102 million a year.

Ireland records the second highest hospitalisation rate for asthma across EU countries and is around 50% above the EU average. This alarming statistic shows that there is an urgent need to improve the management of asthma in primary care.

The Asthma Society’s full PreBudget Submission 2021 can be found online on asthma.ie.

Mr Reid pledged to focus his presidency on ‘collaboration’ and ‘innovation’ as Ireland and the world deal with the social and economic disruption caused

by Covid-19.

Mr Reid said he was looking forward to leading IPHA through the next two years with an agenda focused on integrating medicines innovation deeper into the healthcare system through partnerships with public sector stakeholders across health, enterprise and research.

“Among my first tasks will be to lead negotiations on a new industry-State Agreement that delivers faster access for patients to the new innovative therapies our companies are bringing forward. Ireland still ranks among the slowest countries in western Europe to make new medicines available to patients.

“A new Agreement should be based on the principle of joint

funding, with industry and the State agreeing between them to cover the cost of new medicines.

That is the fairest way to ensure patients get timely access to the best new treatments. The first step is for the Government to allocate in the October Budget new funding for new medicines,” said Mr Reid.

He said the industry’s work on Brexit and Covid-19, and on agreeing an extension to the current Agreement, demonstrated that partnership with the Government works.

“In the Brexit and Covid-19 environment, it is more important than ever for the industry to collaborate across Government so that Ireland can deal with the

serious risks posed by both events and, at the same time, realise the opportunity of medicines innovation. Our industry has been focused on securing the supply of medicines for Irish patients, keeping manufacturing sites going, and searching for vaccines and treatments for COVID-19. We are working too, with others, on positioning Ireland as a leader in emerging areas of medicines innovation such as cell and gene therapies and Industry 4.0. We want to help the Government to prepare for future healthcare shocks through better data and information-sharing, boosting immunisation rates, cooperating on applied research and building health system resilience,” said Mr Reid.

PHARMACYNEWSIRELAND.COM

8

News

Innovation on the Horizon for Garvan Lynch’s Pharmacy in Douglas have recently been awarded a Health Innovation Hub (HIH) Ireland - Health Innovation for 2020. The accolade was received for Pharmacist Garvan Lynch’s DI@DEM innovative Diabetes Management Service.

Garvan Lynch, Pharmacist, Lynch’s Pharmacy

Medicines Shortages The Health Products Regulatory Authority has been notified of a shortage of the following products: • Abstral 100mcg Sublingual Tablet – PA2288/004/002 • Abstral 200mcg Sublingual Tablet – PA2288/004/003

groups, prioritise and assist those patients at risk, communicate with specialists and emergency care.

Each patient receives algorithmic ongoing care feedback, and is contacted if diabetes indicators are above / below normal thresholds.”

Garvan worked in collaboration with Kyriakos Hatzaras - a former Supervisor Imperial College, London, where Garvan completed his MBA, who is now based in Luxembourg as a systems engineer - and Granite Digital in Cork.

As a team, they have previously won selection to the Flag-Ship European Union Health Innovation fund: The Horizon 2020 Project, finishing in the top 10 of projects from over the 500 who started, from around the EU. As a finalist, they were invited to present in Oslo to an audience of academics and health companies in November of last year.

The HIH call, which involved a nationwide health innovation competition is directed at companies who have an innovative product, solution or service that are at pre-commercial or late development phase with the potential to significantly impact Irish healthcare.

Community pharmacist and Company Director Garvan Lynch says, “Our service delivers patient remote monitoring, care intervention, prescription management, medicines data capture at scale, enabled by our

product: a custom-built, fit-forpurpose, enterprise class system operating as: - a virtual assistant, ‘companion’ app with on-screen and voice assistance as a future option; - ready to support management of the next pandemic incl. symptom checking, contact tracing via its configurable version.

“Our diabetes management system (minimum viable product) enables health professionals to monitor diabetes in large patient

Garvan commented, “Being part of the EU Horizon Fund was a truly extraordinary experience. We are in a very select and lucky group of innovators, as getting on the Horizon project is not easy.

“We received assistance in progressing our Medical Device from Experts all over the EU as part of the Horizon project. We have almost completed our journey towards CE marking.

“We are delighted to have been successful with our application to the Health Innovation Hub, Ireland. We are now in our 5th year developing our diabetes medical device and hope to comercialise the device, with the help of the Health Innovation Hub, in the next 9 months.”

PCRS Levy Deduction The HSE PCRS has alerted pharmacists to an error whereby the GMS prescription levy was not deducted from the August 2020 payment in approximately 250 pharmacies. These deductions will be taken from September 2020 payments.

Those affected will be contacted by the HSE PCRS. Should IPU members have any queries, they may contact Paul McCartney, Operations Manager, on 01 864 7100 or a member of the pharmacy processing unit can be contacted for assistance

PHARMACYNEWSIRELAND.COM

• Abstral 300mcg Sublingual Tablet – PA2288/004/004 • Abstral 400mcg Sublingual Tablet – PA2288/004/005 • Abstral 600mcg Sublingual Tablet – PA2288/004/006 • Abstral 800mcg Sublingual Tablet – PA2288/004/007 • Anapen 150mcg Solution for Injection in Pre-filled Syringe – PA22580/001/001 • Estradot 50mcg Transdermal Patch – PA0896/010/002 • Estradot 75mcg Transdermal Patch – PA0896/010/003 • Inspra 50mg Tablet – PA0822/020/002 • Livial 2.5mg Tablet – PA1286/059/001 • Spectrila 10,000IU Powder and solvent for Solution for Infusion/Injection – EU/1/15/1072/001-002 • Telfast 180mg Film Coated Tablet – PA0540/078/003 • Yasmin 0.03mg/3mg Film Coated Tablet – PA1410/023/001 The following shortage has been resolved and supply has resumed to the Irish market: • Evorel 50mcg Transdermal Patch – PA22668/008/001 • Evorel Conti 50mcg/170mcg Transdermal Patch – PA22668/009/001 • Levofloxacin 250mg Tablet – PA1347/048/001 • Levofloxacin 500mg Tablet – PA1347/048/002 • Nimbex 2mg/ml Solution for Injection/Infusion – PA1691/030/001 • Sumatriptan 100mg Film Coated Tablet – PA2315/070/002 • Zolmitriptan 2.5mg Orodispersible Tablet – PA1380/035/003

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Composition: Each film-coated tablets contains 40 mg, 80 mg and 160 mg of Valsartan. Therapeutic indications, posology and method of administration: Adult patients with high blood pressure: The usual dose is 80 mg daily. In some cases, doctor may prescribe higher doses (e.g. 160 mg or 320 mg). May also combine with an additional medicine (e.g. a diuretic). Children and adolescents (6 to 18 years of age) with high blood pressure: Patients with <35 kg weight 40 mg once daily, equal or >5 kg starting dose is 80 mg once daily. In some cases, higher doses prescribed (160 mg to 320 mg). Adult patients after a recent heart attack: After a heart attack, the treatment is generally started as early as after 12 hours, usually at a low dose of 20 mg twice daily. Doctor will increase this dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on individual patient can tolerate. Adult patients with heart failure: Starts with 40 mg twice daily. Doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on individual patient tolerability. Valsartan Krka can be given together with other treatment for heart failure and doctor will decide which treatment is suitable. Valsartan Krka can be taken at about the same time each day with or without food. Swallow it with a glass of water. Contraindications: Hypersensitivity to valsartan and to any of the excipients. Special information about some of the ingredients: Valsartan Krka contains lactose. Intolerance to some sugars, contact your doctor before taking this medicinal product. Special Precautions and Warnings: Avoid taking in cases of: severe liver disease; early pregnancy; more than 3 months pregnant; diabetes or impaired kidney function; below 18 years of age; swelling of the tongue and face caused by an allergic reaction; treated after a heart attack, a combination with ACE inhibitors; treated for heart failure, a triple combination with ACE inhibitors and beta blockers; dehydration caused by diarrhoea, vomiting or high doses of water pills (diuretics). Interactions with other medicinal products and other form of medicines: Treated with a blood pressure lowering medicines such as water pills (diuretics). ACE inhibitors (e.g. enalapril, lisinopril, Ramipril) and aliskiren. An ACE-inhibitor together with certain other medicines for heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (e.g. spironolactone, eplerenone) or betablockers (e.g. metoprolol). Taking potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. Taking certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs). Taking some antibiotics (rifamycin group), ciclosporin (for transplant rejection) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). Taking lithium, for some types of psychiatric illness.

These drugs may increase the effect of Valsartan Krka. Pregnancy and breast-feeding: Stop taking Valsartan Krka if you think or might become pregnant. Not recommended in early pregnancy, and when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy. Not recommended if you are breast-feeding or about to start breast-feeding. Doctor may choose another treatment if you are pregnant and wish to breast-feed, especially if your baby is newborn or was born prematurely. Possible side effects: Common: dizziness, low blood pressure with or without symptoms such as dizziness and fainting when standing up and decreased kidney function. Un common (among others): angioedema, sudden loss of consciousness (syncope), vertigo, impaired kidney functions, muscle spasms, abnormal heart rhythm, breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure), headache, tiredness and weakness. Other side effects: Very rare and unknown.

Contents in the pack: 28 film coated tablets of 40 mg, 80 mg and 160 mg of valsartan. Legal Category: Prescription only medicine. Revised date: April 2018; Marketing authorisation holder: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia. Market authorisation number: 40 mg: PA1347/010/006; 80 mg: PA1347/010/007; 160 mg: PA1347/010/008;. Further information is available on request.

References: 1. Accetto R, Chazova IY, Sirenko Y et al. The efficacy and safety of valsartan and combination of valsartan and hydrochlorothiazide in the treatment of patients with mild to moderate arterial hypertension - the VICTORY trial. Kardiol Pol 2017; 75(1): 55-64.

2. Valsacor (valsartan, 40 mg, 80 mg, 160 mg, 320 mg) Marketing Authorization No: H/06/01597/001-021, Slovenia, 2006.

3. European Directorate for the Quality of Medicines (EDQM), Strasbourg. [URL: http://www.edqm.eu].

4. CEGEDIM, ePharma Market, INTELLIX, IQVIA, MEDICUBE, PHARMAZOOM, PHARMSTANDART 2019.

09/2020, Ireland, 96301-2020, RB/KS.

Film-coated tablets, 40 mg, 80 mg, 160 mg

News Dementia Advisor Posts The HSE has been approved funding for the provision of an additional 10 Dementia Adviser posts and a co-ordinator post from the allocation for the SláinteCare Enhanced Community Care Fund.

The HSE will continue to partner with the Alzheimer Society of Ireland who deliver this vital service.

A Dementia Adviser is a point of contact for people who are concerned about their cognitive health or who have a diagnosis of dementia.

Dementia Advisers enable people to take control of their own lives by providing practical assistance, advice and information, and signpost people with dementia and their carers to appropriate services and supports.

Pat McLoughlin, CEO of The Alzheimer Society of Ireland, said, “This announcement is a really positive step for people with dementia and family carers in Ireland, especially at this time with so many face-to-face dementia services curtailed or closed, due to Covid-19.

Dementia Advisers offer a lifeline to people in their communities.

“Everyone in Ireland should have access to this key community service – no matter what part of the country they live.

“This announcement will make this a reality for many more. It has taken a while to get here and it’s thanks to the expertise of the Dementia Advisers, the HSE National Dementia Office, politicians, grass-roots efforts and our staff who have all recognised the need for more Dementia Advisers and the need for further investments in dementia supports in the future.

“When these new posts were announced in Budget 2020 I said I hoped that a new cycle of adequately supporting people with dementia and their families would begin.

“I still maintain this hope as for too long they have been the forgotten ones. Today is recognition that more dementia supports are badly needed – and we still have a long way to go.”

11

Pharmacists urge Rethink on Healthcare Spending Next month’s budget represents an opportunity for an innovative rethink of healthcare spending, according to the Irish Pharmacy Union (IPU).

Speaking about the IPU’s PreBudget Submission IPU Secretary General Darragh O’Loughlin said, “The health service has suffered from budget constraints for decades. Now in the midst of the Covid-19 pandemic it is recognised that we need to do things differently. The Government must think innovatively and realise the cost savings that are available — we have been shouting about these opportunities for years, and it is more urgent now than ever before to embrace innovation and change our health service for the better.”

The IPU also said savings could be realised, while also improving the nation’s health, by introducing pharmacy-based chronic disease management programmes. “One example would be introducing pharmacy-based screening for atrial fibrillation. A study commissioned by the IPU found this could prevent over 2,300 cardiac events per year with an associated cost saving of ¤45 million. As well as saving lives it would avoid ¤1.36 billion in additional health spending over the next 30 years.

“Why have we not yet implemented the kind of accessible healthcare for common ailments that the Minor Ailments Service in Northern Ireland and its equivalent in Scotland, the Pharmacy First service, both provide?

“In order to realise this potential, there is an urgent need to review the current pharmacy contract.

Developed in 1996 it predates the internet and the current laws governing pharmacies — it is hopelessly out of date,” he added.

Boots Pharmacy roll out Staff training Boots Ireland has undertaken a significant step in supporting people living with dementia in communities across Ireland by providing training to all staff that will promote a dementia-inclusive environment across its 89 retail and pharmacy outlets.

Martha Ryan, Head of HR and Joe Scallan Head of Stores, Boots Ireland are pictured alongside Fiona Foley, National Coordinator Dementia: Understand Together in Communities

With World Alzheimer’s Day taking place on the 21st September, it was a timely reminder about the need for society to nurture greater understanding and awareness of the challenges and experiences of those living with dementia.

In Ireland, there are more than 64,000 people living with dementia and more than half a million people have a family member who have been affected by the condition.

With that in mind, Boots Ireland set out to develop a training module that would allow its staff to identify people with dementia when they visit a store or pharmacy and the ways in which a staff member can facilitate a dementia-inclusive experience for the customer.

The training, which was developed with the Dementia: Understand Together campaign, has been rolled out to over 2,000 staff members in all 89 boots stores across Ireland. Led by the HSE in partnership with the Alzheimer Society of Ireland and Age Friendly

Ireland, the Dementia: Understand Together campaign is one of six key priorities of the Irish National Dementia Strategy.

The training modules were specifically modified for Boots staff and included testimonials from people living with dementia.

Staff were given insight into the ways in which they can recognise behaviours that could indicate that a person may have dementia and identify common challenges a person with dementia may encounter in a store environment and the range of options they can consider for supporting them.

Staff were trained on the ways they can modify the support given to customers to help overcome simple barriers they may experience.

Speaking about the awareness training, Joe Scallan, Head of Stores at Boots Ireland said: “Caring for communities is at the heart of our culture in Boots and the dementia awareness training that we have recently rolled out across all our stores is part of our continued commitment to caring for our customers in communities throughout Ireland. When someone living with dementia visits a Boots store, they will be met by friendly, trained staff who understand the condition and can provide an experience that is inclusive and caters for their needs. We are delighted to have reached a point where we can announce the initiative and look forward to supporting those living with dementia in our stores.”

PHARMACYNEWSIRELAND.COM

12

News

All Change in Pharmacy Leading News as Uniphar signs agreement with Hickeys It was a case of all change on the pharmacy landscape during September.

In a surprise announcement, 36-store strong Hickey’s Pharmacy Group stated that they have signed an agreement with Uniphar.

Uniphar says its latest acquisition of the Hickeys chain will boost its buying power with drug makers and immediately contribute to the group's bottom line.

Arthur Cox advised Hickeys on the sale.

Uniphar already has 299 owned and franchised pharmacy shops across Ireland, trading under the Allcare and Life Pharmacy brands, including 17 purchased last year.

The deal adds the fifth biggest independent chain in Ireland with shops in Dublin (21), Cork, Meath, Louth, Kildare and Wexford, which will continue to trade under the Hickeys brand once the deal closes, subject to Competition and Consumer Protection Commission approval. It is believed the proposed acquisition has been notified to the CCPC. Uniphar today also reported higher revenues and profits for the six months to the end of June despite what it called a "difficult operating environment".Revenues for the six month period on a reported basis rose by 8.8% ¤871.33m while profit before tax, excluding exceptional items, increased by 19.9% to ¤16.41m.

The company also reported a 23.6% increase in its half yearly gross profits to ¤102.6m and noted that gross profits generated from outside of Ireland increased by more than 80% in the six month period.

Uniphar said it is playing a critical role during the Covid-19 pandemic as it ensures continuity in the supply of medicines, medical

Paddy Hickey, Founder, Hickey's Pharmacy Group

Ger Rabette, CEO, Uniphar

PHARMACYNEWSIRELAND.COM

devices and related services to the healthcare sector.

A statement from Hickey’s said, “This is a very significant milestone in the development of Hickey’s Pharmacy and one that will strengthen the business even further as it enters its next phase.”

Uniphar is a global partner to pharma and MedTech manufacturers working to improve patient access to medicines in Europe and around the world.

Set up by a group of Irish community pharmacists more than 50 years ago, it is one of the leading suppliers in the wholesale market and currently operates two nationwide pharmacy groups – Allcare Pharmacy and Life Pharmacy.

The statement added, “The Hickey’s Pharmacy team are fully committed to providing exceptional patient and customer care and the change in ownership will not impact the standard of care each and every one of our valued patients receives in their local Hickey’s Pharmacy. It is also important to note that as part of the change of ownership

all employee entitlements and rights will be fully protected and maintained.”

Having reached its 25 year anniversary in August, Hickey’s Pharmacy has grown and developed into the country’s leading Irish-owned community pharmacy group.

Founder and Managing Director Paddy Hickey commented, “We have a proud heritage of serving our customers and catering to the needs of individuals, families and patients in residential care, whilst also being very much part of the communities which we serve. I would like to personally acknowledge and thank each and every one of the Hickey’s team for their support and loyalty over the years who have ensured we maintain the highest standard of patient and customer care.”

With Ireland’s other leading wholesaler, United Drug, owning LloydsPharmacy Group, what this means for independent pharmacy and the remainder of pharmacy businesses remains to be seen. Irish Pharmacy News will have more on this in the November issue.

News

13

Sector in Crisis Is a Lack of Government Support resulting in Pharmacy Casualties?

The pharmacy sector was left reeling last month when it was announced an interim examiner has been appointed to Cara Pharmacy Group.

Ramona Nicholas, star of RTE’s Dragons Den and the Secret Millionaire television series. from Arboe in Co Tyrone, co-founded Cara Pharmacy Group along with her husband Canice. Both are trained pharmacists.

Now, the largest creditor of the pharmacy chain has moved to put the business into examinership.

Debt financier DunPort, which is owed ¤14 million by the healthcare group, applied to the High Court to appoint accountant Ken Tyrell of PWC as an interim examiner though a High Court application.

The announcement highlights the unsustainable financial pressures on the community pharmacy

sector, according to the Irish Pharmacy Union (IPU).

Recent research by the IPU found that it is costing the pharmacy sector over ¤10 million a month to remain open and to provide safe care. In addition, pharmacies have reported retail sales falling by an average of 36% since the start of the crisis. One in five pharmacies has laid off staff, while another two in five (38%) indicated they would have to do so over the next few months.

IPU Secretary General Darragh O’Loughlin said, “Ongoing deep cuts in funding over the last decade, together with the impact of COVID-19, have taken a heavy

Ramona Nicholas, Managing Director, Cara Pharmacy Group

toll and pharmacy finances are now in critical condition, with the pressure on the sector becoming increasingly intolerable. This is compounded by the fact that, despite huge additional investment in health services and substantial additional resources for other health professions, pharmacists have received little or no direct financial support from the Government for remaining open and accessible to patients and the public.”

Generic and biosimilar medicines set to free up ¤1bn As Irish Pharmacy News was going to press, Medicines for Ireland (MFI), the Irish pharmaceutical trade association and the supplier of the majority of medicines in Ireland, launched ‘Reductions in the Cost of Medicines’, a report outlining how the Government can achieve a national saving of up to €1 billion over the next five years by switching to generic and biosimilar medicines.

To put into context, ¤200 million of additional saving per annum could be redirected towards additional HSE resources, paying for 6,000 additional nurses or 3,500 extra nursing home beds.

Commenting on the report which was shared with Oireachtas members, Chair of Medicines for Ireland, David Delaney said, “It is well recognised by the HSE and the Department of Health that the increased use of generic medicines has delivered ¤1.6 billion in savings to the Irish health system since 2013. These savings have been delivered by the members of MFI who supply the majority of medicines to the HSE and to patients directly.

“Covid-19 has placed added pressure on an already overstretched health system. The policy proposals set out in this report outline the opportunity for Government to free up significant HSE resources by avoiding an annual spend of hundreds of millions of euro on high cost patented medicines. Over the

last decade, the increased use of generic medicines in Ireland has helped dramatically reduce the cost of everyday health care.

These reductions have helped families across the county access a greater range of medicines due to generic competition. While this has resulted in the era of the big brand being dealt a blow, an increased use of generic and biosimilar medicines will help protect public finances and the HSE budget, with the possibility of redirecting savings into other much needed HSE resources.”

Mr Delaney added, “In the last 12 months the average reimbursed price of generic medicines was six times less expensive when compared with non-generic medicines, illustrating the very significant savings that can be availed of at both national and local level. Significantly, an increase in biosimilar medicines usage will lead to an increase in savings, greater patient access and better security of supply thereby freeing money up for the funding of frontline services such

David Delaney Chairperson Medicines for Ireland

as hospital beds as well as provide for much needed specialist staff.

“Failure to address the high cost of medicines, with more sustainable generic or biosimilar options, will ensure that funding constraints remain a millstone around the neck of an already overstretched healthcare system. The current penetration rate for biosimilars medicine in Ireland is below 50% while the average across other EU countries is in the range of 80 – 90%, demonstrating the immense opportunity for further savings in this area.

“Medicines for Ireland (MFI) members are at the forefront of national efforts to ensure that patients continue to access medicines despite the multitude of challenges that the Covid-19 pandemic introduced to the global medicine supply chain. This report is a result of a detailed analysis

carried out by MFI to support its work and help stakeholders across Ireland optimally modernise public policy to ensure there is a sustainable supply of medicine to patients in Ireland. The result of all this equates to increased patient access to cost effective everyday medicines.”

PHARMACYNEWSIRELAND.COM

14

News

Insulin pump therapy uptake low in Ireland New research has identified that insufficient structure of the health service, lack of awareness and individual preferences are among barriers for adults with type 1 diabetes in getting insulin pump therapy.

Dr Katarzyna Gajewska, Lead author, HRB PhD Scholar, RCSI Even though insulin pump therapy is recommended as a first-choice therapy for pre-schoolers and is beneficial for people with type 1 diabetes of all ages, only 10.5% of people with type 1 diabetes in Ireland is using a pump to administer their insulin.

This compares significantly lower to the average uptake in Nordic, Central and Western countries, which was 15–20% in 2010.

The study was led by researchers from RCSI University of Medicine and Health Sciences.

This research builds on previous studies by RCSI researchers, which showed that people with type 1 diabetes in Ireland use insulin pump therapy at lowered rates compared internationally and there is an unequal availability of insulin pump therapy in Irish adult diabetes clinics.

Regional disparities in insulin pump use were found, with uptake as low as 2% among adults in Roscommon compared to 9.6% in Kildare. One-third of Irish adult clinics, usually in rural areas, do not offer any type of insulin pump therapy support, and less than a half provides training to commence the therapy.

To identify the reasons for why uptake is lower in Ireland, the researchers conducted 21 interviews and four focus groups among people with type 1 diabetes, healthcare professionals and other key stakeholders.

The same topics were discussed in all groups and aligned with

four main themes: awareness, structure, capacity and impact of an individual (a person with diabetes or healthcare professional). The main finding was that if the structure of the health service is insufficient, the quality of care is not standardized and capacity is poor, the uptake of insulin pump therapy is more reliant on the individual’s interest, leadership skills, willingness and motivation.

“These factors may make the regional differences in accessing diabetes related technology and the quality of care more evident,” said Dr Katarzyna Gajewska, the study’s lead author and HRB PhD scholar in population health and health service research at RCSI. “The results of this study may inform healthcare professionals and policy makers regarding gaps in the delivery of diabetes care. Solutions are needed to reduce the disparities in health service provision in the countries where reimbursement of diabetes technology is offered. Such steps may include the development of national guidelines, models of care, and structured approaches to provide equal access to insulin pump therapy across the country.”

Pharmacy promotes ‘Shop Local’ Community pharmacies across Ireland have been busily promoting the ‘Shop Local’ initiative nationwide.

More than half of those who are working from home as a result of Covid-19 restrictions estimate they are sitting down for an average of two hours and 40 minutes longer per day, a new survey has found.

The survey which was commissioned by the Irish Heart Foundation is warning of the dangers of sitting down for long periods and calling on workers to move for a minute each hour during the working day.

Conducted by Ipsos MRBI between August 1 and 10, the survey found that more than half of all workers in Ireland have been able to work from home since restrictions began, with 53 per cent of them sitting down for longer than when in the office or their usual place of work.

Community pharmacists have a key role to play in advising customers on the prevention and management of cardiovascular disease conditions. Now is the time to be advising those who visit the pharmacy on the benefits from greater health and lifestyle choices.

The survey was conducted as part of the Irish Heart Foundation’s Escape Your Chair Heart campaign which runs for the month of September and is supported by the HSE. The campaign calls on the nation to get up and move for a minute each hour during the day as a way to kick-start their daily exercise.

A leading cardiologist has warned that thousands of patients could be ignoring the signs and symptoms of a potentially life-threatening heart issue due to fear of attending healthcare providers during the Covid-19 pandemic.

Shop Local is a non-profit initiative that hopes to support Irish SMEs with the mantra 'Support local, Shop local and Stay safe.’

The new initiative, which is free, is also useful for vulnerable people who are self-isolating and unable to get out to shop themselves.

The site’s comprehensive list of categories include everything from Arts and Crafts, Books and Stationery, Fruit and Veg, Meat and Poultry, and even Children and Baby products.

PHARMACYNEWSIRELAND.COM

Pharmacy Role in CVD

Recent figures published by the National Treatment Purchase Fund (NTPF) reveal a decline of over 300,000 outpatient appointments in Ireland between March and April this year compared to the same period in 2019.

PATIENTS CAN DO IT

WITH THEIR PHONES1 Digital health tools that work together for seamless diabetes management

Caregivers can remotely monitor their loved ones3

Healthcare providers have secure, online access to glucose insights2 Patients can conveniently check their glucose using their phone1

For more information visit FreeStyleDiabetes.ie Images are for illustrative purposes only. Not actual patient data.

1. The FreeStyle LibreLink app is only compatible with certain mobile devices and operating systems. Please check the website for more information about device compatibility before using the app. Use of FreeStyle LibreLink requires registration with LibreView. 2. The LibreView website is only compatible with certain operating systems and browsers. Please check www.libreview.com for additional information.

3. The LibreLinkUp app is only compatible with certain mobile device and operating systems. Please check www.librelinkup.com for more information about device compatibility before using the app. Use of LibreLinkUp and FreeStyle LibreLink requires registration with LibreView. The LibreLinkUp mobile app is not intended to be a primary glucose monitor: home users must consult their primary device(s) and consult a healthcare professional before making any medical interpretation and therapy adjustments from the information provided by the app.

© 2020 Abbott. The shape of the circle sensor unit, FreeStyle, Libre, and related brand marks are owned by Abbott. ADC-27276 V1.0 09/20.

16

News

Transforming Pharmacy Together Goals to support the transformation of the pharmacy profession around the world have been launched by the International Pharmaceutical Federation (FIP).

The journey from the FIP Pharmaceutical Workforce Development Goals to the FIP Development Goals and education and are set to transform pharmacy in alignment with wider global imperatives underpinning the UN Sustainable Development Goals (SDGs).

Says the organisation, “Having a set of ‘One FIP’ Development Goals enables us to identify commonalities across all areas of FIP, as well as some unique attributes in each area. We believe it is imperative to bring science, practice and workforce & education together into one transformative framework for our members and the wider profession to clearly set out the goals for development for the next decade.

The FIP Development Goals build on 13 Pharmaceutical Workforce Development Goals for pharmacy education developed by the federation in 2016. Additions have been made to these 13 goals and eight new goals have been developed, providing a total of 21 goals relevant to fields of practice and science as well as to workforce and education.

The new goals cover: • Medicines expertise • People-centred care

• Communicable diseases • Antimicrobial stewardship • Access to medicines, devices & services • Patient safety • Digital health • Sustainability in pharmacy “These goals are a major development for pharmacy, providing a comprehensive key resource facilitating needs-based transformation of our whole

profession nationally, regionally and globaly. They are a logical next step, linking the pharmaceutical workforce with the pharmaceutical services we deliver, underpinned by pharmaceutical science,” said Dr Catherine Duggan, CEO, FIP. The FIP Development Goals are a key resource for transforming the pharmacy profession over the next decade globally, regionally and nationally. They align with FIP’s mission to support global health by enabling the advancement of pharmaceutical practice, sciences

“The work builds on the Pharmaceutical Workforce Development Goals resulting in 21 FIP Development Goals – FIP wide goals for transforming global pharmacy. Each of the FIP DGs is composed of 3 Elements for Practice, Science and Workforce that all form fundamental categories of the Goals. Alongside each Element is a set of mechanisms which form tools and structures to facilitate and support the process of transformation.

“With the FIP Development Goals, FIP is set to transform global pharmacy working in partnership and collaboration with our members everywhere.”

Consumer demand for vitamins surges due to Covid-19 The Covid-19 pandemic has sparked a surge in demand for vitamin supplements in Ireland according to new data. United Drug, Ireland’s largest pharmaceutical wholesaler, found immunity-boosting ranges of vitamin supplements such as vitamin C, vitamin D and zinc recorded a 142% increase between March and July this year compared to the same period in 2019. Recent studies in Ireland have urged the widespread use of vitamin D supplements to help fight Covid-19 infection.

The data revealed the sales of vitamin groups including children’s vitamins (108%), multivitamins (69%) and women’s health (23%) also increased significantly during the lockdown period. While joint care products increased by 46%, food supplement and weight management products sales decreased by 83% and 41% respectively.

Commenting on findings, Denis O’Driscoll, Pharmacist at United Drug said: “Vitamins can play a pivotal role in fighting viral infections and the demand both from pharmacies and consumers during the height of the health crisis was unprecedented. Ireland is not alone in seeing this spike with other countries including the USA seeing a similar trend.”

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“We saw a 500% increase in demand for some vitamin products highlighting how consumer behaviour reacted to the pandemic. As we enter Autumn, Irish consumers will continue to look at ways to boost their overall health and wellbeing with vitamin supplements considered to be one avenue to help achieve this.”

United Drug is the largest supplier of medicines to community pharmacists and hospitals in Ireland. The company is part of the McKesson Corporation, a global leader in healthcare whose Irish operations includes United Drug, Lloyds Pharmacy, TCP Homecare and Median Healthcare.

solves everyday health issues. available to order from Brandshapers

Phone: 053 91 79007

Email: customerservice@brandshapers.ie

18

News

United Drug Partner with Aware United Drug have announced a new two year partnership with Aware to help support the charity with their vision to create a society where people affected by stress, depression, bipolar disorder and mood related conditions are understood, supported, free from stigma, and are encouraged to access appropriate therapies.

Paul Reilly, Managing Director, McKesson Ireland

be working to educate and support their staff throughout the partnership.

Aware was chosen as the new charity partner after a companywide vote and a period of research which was conducted across McKesson Ireland which includes businesses operating under the TCP Homecare, LloydsPharmacy, Median Healthcare and United Drug brand names. The new partnership will commence from October 1st and as part of the partnership United Drug hope to not only support Aware through fundraising but also to increase mental health awareness and support for McKesson Ireland staff and customers. Now more than ever it is important that people prioritise their mental health and United Drug, together with Aware, will

Aware is a non-profit organisation providing education, support and information around depression and Bipolar Disorder. More than 450,000 people in Ireland experience depression (1 in 10) at any one time but many hide their condition and never get help.

The help Aware provides to those suffering is essential, and in these difficult times the need for that support is more important than ever.

Paul Reilly, Managing Director of McKesson Ireland commented, “We are delighted to announce that Aware will be our charity partner over the next two years.

We hope to create a valuable partnership, which sees their excellent work supported and promoted amongst our staff. Now more than ever, we all need to be aware of the signs of distress and actions we can all take as a society to help remove the stigma around mental health and we look forward to announcing a series of employee led fundraising initiatives and awareness events soon.”

Stephen Butterly, Head of Fundraising & Business Development at Aware added, “We are delighted to have been chosen as charity partner for McKesson Ireland and would like to convey our thanks to each and every staff member who voted for us. Simply by choosing Aware, you have already helped us in our mission to reduce stigma by acknowledging the importance of mental health to us all, whether we need support or wish to learn the skills and tools to proactively look after our mental health.

“Like the majority of organisations, big and small, Aware is facing new operational and financial challenges since the emergence of Covid-19. For Aware, this is within the context of a dramatic increase in demand for our services as we adjust to the socioeconomic consequences of Covid-19 and a new way of life. We are addressing these challenges head on and with the support of charity partners like you, Aware remains fully committed to our vision and the provision of our free support, education and information services. Essential services which have a significant and positive impact on individuals, families and communities all over Ireland.

“On behalf of our 400+ support volunteers nationwide, on behalf of our small staff, and most importantly, on behalf of all of those who will benefit directly because of your efforts, thank you. We look forward to working closely with all at McKesson Ireland to bring this partnership to life.”

Pharmacy Remuneration Pharmacist remuneration models in ever-evolving healthcare settings must be examined if global health is to be supported, FIP has said in a new policy statement on the sustainability of pharmacist-delivered professional services.

“A common concern among pharmacy associations worldwide is the long-term financial viability of professional services delivered by pharmacists. These concerns are first and foremost triggered by the impacts of continued price and margin cuts in dispensing of medicines and the non-allocation of funding in many settings for extended professional services and social care,” said Paul Sinclair, chair of FIP’s Board of Pharmaceutical Practice.

“A successful remuneration model is one that promotes sustainable delivery of professional services. These should be integrated into broader health system strategies and, therefore, funding plans. COVID-19 has proven how important pharmacy is to health care. Governments and policymakers must acknowledge that the viability of the pharmacy profession is an issue for the broader health sector and society as a whole,” Mr Sinclair added.

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Breakthrough trial for MND Researchers at Trinity College Dublin are to participate in an early phase gene-based clinical trial for motor neuron disease (MND).

The research team represents one of only four centres in Europe to take part in such an exciting clinical trial for this devastating disease. The first Irish patient entered the study at the Clinical Research Facility at St James’s Hospital Dublin last month (September).

MND is a devastating condition, which causes progressive paralysis, increasing physical disability and ultimately death within an average of two to three years. There are over 350 people in Ireland with MND, and one person is diagnosed every 3 days with the condition. There is currently no effective treatment.

The clinical trial, sponsored by the US Pharmaceutical Company Biogen, targets an abnormal expansion of the MND-associated gene C90rf72 using a novel gene therapy that is designed to switch off the abnormal part of the gene.

Up to 10% of all people diagnosed in Ireland with MND carry the abnormal C9orf72 gene, which can cause both MND and dementia.

The Phase 1 trial which has been divided into five sections involving 75 patients worldwide, was recently approved by the HPRA (Health Products Regulatory Authority). Only 24 patients in the world will be enrolled in the fifth section, including the first Irish patient to enter the study.

Professor Orla Hardiman, Principal Investigator in the Irish part of the study and a leading world authority on MND says, “Gene therapy is an exciting new approach and considerable progress has already been made in turning off another MND associated gene (SOD1), as the results of early clinical trials have shown. We are very hopeful that the same approach will work for those with the C9orf72 gene.”

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RELIABLE: Movymia®’s quality, safety and efficacy is highly similar to its reference product1,2,* EFFECTIVE: Anabolic MoA effectively rebuilds bone through the stimulation of osteoblasts1,3 AFFORDABLE: Allows more eligible patients to benefit due to its cost advantage4,5 RE-USABLE: One high quality reuseable pen for the entire treatment period1 MOVYMIA 20 MICROGRAMS/80 MICROLITERS SOLUTION FOR INJECTION Each dose of 80 microliters contains 20 micrograms of teriparatide. One cartridge of 2.4 ml of solution contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml).

Presentation: Glass cartridge. Indications: Movymia is indicated in adults. Treatment of osteoporosis in postmenopausal women and men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. Dosage: The recommended dose is 20 micrograms administered once daily. Patients should receive calcium and vitamin D supplements if dietary intake is inadequate. The maximum total duration of treatment is 24 months. The 24 month course should not be repeated over a patient’s lifetime. Following cessation of teriparatide therapy, patients may be continued on other osteoporosis therapies. Teriparatide must not be used in severe renal impairment. Use with caution in moderate renal impairment and impaired hepatic function. Teriparatide should not be used in paediatric patients (less than 18 years), or young adults with open epiphyses.

Method of administration: Movymia should be administered once daily by subcutaneous injection in the thigh or abdomen. It should be administered exclusively with the Movymia Pen reusable, multidose medicine delivery system and the injection needles which are listed as compatible in the instructions provided with the pen. The pen and injection needles are not included with Movymia. However, for treatment initiation a cartridge and pen pack should be used. Movymia must not be used with any other pen. Patients must be trained to use the proper injection techniques. Contraindications: Hypersensitivity to the active substance or excipients. Pregnancy and Breast-feeding. Pre-existing hypercalcaemia, severe renal impairment, metabolic bone diseases other than primary osteoporosis or glucocorticoid-induced osteoporosis, unexplained elevations of alkaline phosphatase, prior external beam or implant radiation therapy to the skeleton, patients with skeletal malignancies or bone metastases. Warnings and precautions: In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide.

Therefore, if blood samples for serum calcium measurements are taken, this should be done at least 16 hours after the most recent teriparatide injection. Routine calcium monitoring during therapy is not required. Teriparatide may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials. Teriparatide should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition. In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, was relieved by placing subjects in a reclining position, and did not preclude continued treatment. Caution should be exercised in patients with moderate renal impairment. Experience in the younger adult population, including premenopausal women, is limited. Treatment should only be initiated if the benefit clearly outweighs risks in this population. Women of childbearing potential should use effective methods of contraception during use of teriparatide. If pregnancy occurs, teriparatide should be discontinued. The recommended treatment time of 24 months should not be exceeded. Contains sodium. Interactions: Digoxin, digitalis. Fertility, pregnancy and lactation: Women of childbearing potential should use effective methods of contraception during use of teriparatide. If pregnancy occurs, Movymia should be discontinued. Movymia is contraindicated for use during pregnancy and breast-feeding.

The effect of teriparatide on human foetal development has not been studied. The potential risk for humans is unknown. Driving and operation of machinery: Teriparatide has no or negligible influence on the ability to drive and use machines. Transient, orthostatic hypotension or dizziness was observed in some patients. These patients should refrain from driving or the use of machines until symptoms have subsided. Undesirable effects: Nausea, pain in limb, headache, dizziness. Refer to Summary of Product Characteristics for other adverse effects. Pack size: 1. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. Marketing authorisation holder: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, German. Marketing authorisation number: EU/1/16/1161/001-003. Medicinal product subject to medical prescription. Date last revised: July 2019.

1. Movymia® SmPC. 2. Movymia® EPAR – public assessment report, available at: https://www.ema.europa.eu/documents/assessment-report/movymia-epar-public-assessment-report_en.pdf 3. Brixen KT et al. Basic Clin Pharmacol Toxicol. 200494(6):260–70. 4. Lyman GH et al. N Engl J Med. 2018378(21):2036–2044. 5. Janjigian YY et al. Future Oncol. 201814(23):2403–2414.* Forsteo®

October 2019. 2019/ADV/TER/122H

20

Biosimilars

Opportunities for Pharmacy within the Biosimilars Landscape

J

ust a couple of months ago (August), pharmacists across Ireland called on the Minister for Health Stephen Donnelly TD to change legislation to allow them substitute expensive biological medicines for more cost-effective biosimilars.

In 2017 the Department of Health held a public consultation on a National Biosimilar Medicines Policy, and IPU proposals showed ¤370 million in potential savings were possible if action was taken.

Nearly three years later, there has been no action and those savings have not been made.

In 2013 pharmacists began facilitating Government policy on the use of generic medication.

Consequently, the use of generic medicines in Ireland increased from 17% to over 40%, generating a total of ¤1.145 billion in savings for the State.

As the experience of generic substitution demonstrated, allowing community pharmacists to substitute is the fastest and most effective way to ensure a rapid and meaningful increase in the usage of biosimilars.

Niamh Cahill looks at the current state of play and goes further into what the future landscape may look like.

Generic substitution was introduced in 2013. Since this time it has led to savings of ¤1.1 billion, according to the Irish Pharmacy Union (IPU).

Its implementation has without doubt been a success story.

Perhaps this is why pharmacists

are seeking the implementation of another substitution scheme, this time for biosimilars.

The IPU recently called on Minister for Health Stephen Donnelly to change the law to allow them substitute expensive biological medicines for more cost-effective biosimilars.

The move, first proposed by the Union in 2017, could save the state millions of euro, the IPU has argued.

Yet, the proposal, despite appearing to be a ‘no brainer’, has been met with silence from Government.

In Ireland, the issue of substitution and interchangeability of biosimilars is addressed through the Health (Pricing and Supply of-Medical Goods) Act 2013. The law prohibits the substitution of biological medicines.

“If the Government had implemented this [biologic substitution] in 2017 when we pointed it out we would have already made a saving of ¤370 million.

“It seems illogical that they [Government] wouldn’t look at it. On the surface it looks like a relatively easy measure to implement and it’s not new, as such, because we have generic substitution for standard drugs, and that’s working very well.

We’ve seen that increase from 17 per cent to over 40 per cent.”

A biosimilar is a biological medicine that is highly similar to another, already authorised biological medicine.

Due to the complex manufacturing process, biosimilars are not identical versions of the reference product, and as such are not considered generics.

IPU Vice President Eoghan Hanly, a pharmacist based in Loughrea, Co Galway, admitted that changes in legislation at any time, never mind during a global pandemic, are difficult.

Because of this, the issue of interchangeability and equivalence has become an area of intense debate, both in Europe and worldwide, according to the HSE.

“When we’re looking on the added pressure on the health system with Covid, I think we should be looking at all the savings we can,” said Mr Hanly.

Like biologics, biosimilars are used to treat long-term conditions such as inflammatory bowel disease, rheumatoid arthritis and psoriasis.

PHARMACYNEWSIRELAND.COM

Although biosimilars and biological medicines are different, in order for a biosimilar to be licensed, it must be shown that there are no clinically meaningful differences between it and the reference or originator biological medicine.

Essentially, regulators must be confident that the quality, safety and efficacy of both medicines is comparable.

According to the HPRA, once approved, “biosimilars can be used interchangeably with the reference medicine or with other biosimilars of that reference medicine, under the supervision of a physician. Once a biosimilar has been approved, it can be considered safe to switch to, should a prescribing physician wish to do so.”

Low uptake According to the HSE, biosimilars have been safely used in clinical practice in the EU for over 10 years, and with over 700 million patient days of experience there have been no new safety concerns associated with their use.

According to the Health Products Regulatory Authority (HPRA), about 66 biosimilars

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Confidence, Convenience, Compliance Abbreviated Prescribing Information Please refer to the Summary of Product Characteristics (SmPC) before prescribing Pelgraz▼(pegfilgrastim) 6 mg solution for injection in pre-filled injector.

Presentation: Each pre-filled injector contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The concentration is 10 mg/mL based on protein only**. *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). ** The concentration is 20 mg/mL if the PEG moiety is included. Indications: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Dosage and Administration: Pelgraz therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. Posology: One 6 mg dose (a single pre-filled injector) of Pelgraz is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. Safety and efficacy of Pelgraz in children and adolescents has not yet been established and no recommendation on a posology can be made. No dose change is recommended in patients with renal impairment, including those with end-stage renal disease. Method of administration: Pelgraz is for subcutaneous use. The injections should be given subcutaneously into the thigh, abdomen or upper arm. See SmPC for instructions on handling of the medicinal product before administration. Contraindications: Hypersensitivity to pegfilgrastim or any of the excipients in Pelgraz. Warnings and precautions: To improve the traceability of biological medicinal products, the trade name of the administered product should be clearly recorded. The long-term effects of pegfilgrastim have not been established in acute myeloid leukaemia (AML); therefore, it should be used with caution in this patient population. Granulocyte-colony stimulating factor (G-CSF) can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro. The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML. The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established. The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens. Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk. The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Adult Respiratory Distress Syndrome (ARDS). In such circumstances pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment given. Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, glomerulonephritis resolved after dose

www.accord-healthcare.ie

reduction or withdrawal of filgrastim and pegfilgrastim. Urinalysis monitoring is recommended. Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care. Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim. Spleen size should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain. Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.

Regular monitoring of platelet count and haematocrit is recommended. Special care should be taken when administering single or combination chemotherapeutic medicinal products which are known to cause severe thrombocytopenia. Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease. Therefore, use caution when prescribing pegfilgrastim in patients with sickle cell trait or sickle cell disease, monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vasoocclusive crisis. White blood cell (WBC) counts of 100 x 109 /L or greater have been observed in less than 1% of patients receiving pegfilgrastim. No adverse reactions directly attributable to this degree of leukocytosis have been reported. Such elevation in WBCs is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product. Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy. If leukocyte counts exceed 50 x 109 /L after the expected nadir, this medicinal product should be discontinued immediately. Hypersensitivity, including anaphylactic reactions, have been reported with pegfilgrastim. Permanently discontinue pegfilgrastim in patients with clinically significant hypersensitivity. Do not administer pegfilgrastim to patients with a history of hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Stevens- Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, treatment must not be restarted at any time. As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of antibodies against pegfilgrastim is generally low. Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present. Aortitis has been reported after filgrastim or pegfilgrastim administration in healthy subjects and in cancer patients. The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and WBC count). In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of filgrastim or pegfilgrastim. The safety and efficacy of Pelgraz for the mobilisation of blood progenitor

Oncology & Haematology

cells in patients or healthy donors has not been adequately evaluated. Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings. This should be considered when interpreting bone- imaging results. This medicinal product contains 50 mg sorbitol in each unit volume, which is equivalent to 30 mg per 6 mg dose. Pelgraz contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free’. The needle cover contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Pregnancy and Lactation: Pegfilgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Adverse Events include: Adverse events which could be considered serious include: Common: Thrombocytopenia. Uncommon: Sickle cell crisis, capillary leak syndrome, glomerulonephritis, hypersensitivity reactions (including angioedema, dyspnoea, anaphylaxis), splenic rupture (including some fatal cases), Sweet’s syndrome (acute febrile dermatosis), pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema and pulmonary fibrosis have been reported. Uncommonly cases have resulted in respiratory failure or ARDS which may be fatal. Rare: Aortitis, pulmonary haemorrhage, Stevens-Johnson syndrome. Other Very Common adverse events: Headache, nausea, bone pain. Other Common adverse events: Leukocytosis, musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain), injection site pain, non-cardiac chest pain. See SmPC for details of other adverse events. Shelf Life: 3 years. Store in a refrigerator (2°C – 8°C).

Pelgraz may be exposed to room temperature (not above 25°C ± 2°C) for a maximum single period of up to 72 hours. Pelgraz left at room temperature for more than 72 hours should be discarded. Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Pelgraz. Keep the container in the outer carton in order to protect from light. Pack Size: One prefilled injector with one alcohol swab, in a blistered packaging. Marketing Authorisation Number: EU/1/18/1313/002. Marketing Authorisation Holder (MAH): Accord Healthcare S.L.U, World Trade Center, Moll de Barcelona, s/n, Edifici Est, 6a planta, Barcelona, 08039 Spain. Legal Category: POM. Full prescribing information including the SmPC is available on request from Accord Healthcare Ireland Ltd, Euro House, Little Island, Co. Cork, Tel: 021-4619040 or www.accord-healthcare.ie/products. Adverse reactions can be reported to Medical Information at Accord-UK Ltd. via E-mail: medinfo@accord-healthcare.com or Tel: +44(0)1271385257.

Date of Generation of API December 2019. IE-01454

Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie), or by e-mailing medsafety@hpra.ie. Adverse events should also be reported to Medical Information via email; medinfo@accord-healthcare.com or tel:0044 (0) 1271 385257

May 2020. IE-01429

22

Biosimilars Eoghan Hanly, Vice President, IPU

“¤62 billion worth of biological medicines are expected to go off patent by 2020 globally, providing significant savings possibilities, and there is already a potential three year saving of ¤370 million for the Irish health system – none of which will be realised if biosimilar usage in Ireland is not brought to European norms,” read a statement from the IPU.

equal footing. Achieving savings on drugs, therefore, has never been more critical for the health service.

In April 2019, the HSE published the document: Guidance for Biological Medicines in Acute Hospitals.

How would it work?

The report outlined that the projected annual spend for biological medicines with a biosimilar alternative available was about ¤260 million in 2018.

According to HPRA guidance, patients should avoid switching back and forth between a biosimilar and a biological reference medicine.

are authorised by the European Medicines Agency (EMA).

Ireland’s uptake of biosimilar medicines remains low compared to other EU countries.

Mr Hanly pointed out that Spain has a 70 per cent uptake of biosimilars, for instance, but in Ireland our rate is less than 10%.

Uptake of biosimilars across the EU has generally been considered slower than anticipated, despite the obvious healthcare savings.

Biological medicines and biosimilars fall under the HSE High Tech Drugs Scheme (HTDS). Spending on drugs under the scheme has increased significantly in recent years.

According to the report “PCRS Statistical Analysis of Claims and Payments 2019”, payments to manufacturers and wholesalers of high tech drugs and medicines totalled ¤849.22 million last year.

In 2018, the figure was ¤781.23 million; in 2010 the spend totalled ¤345 million.

Patient care fees of ¤25.84 million were paid to pharmacists under high tech arrangements in 2019, meanwhile. More than 88,748 individuals availed of high tech arrangements last year.

According to Mr Hanly, the HSE are estimating that by 2021, spending on all high tech drugs and standard drug medication costs nationally will be on an

The IPU has proposed that a pharmacist, on receiving the initial high tech prescription for a patient, would make the decision to dispense and supply a biosimilar or the biological reference medicine.

A note of this would be made in the patient’s medication record and, because the patient nominates a single specific pharmacy for their high tech medicine, subsequent supplies would be for the same product and no further switching would occur.

“It’s the same efficacy, the same safety, it has to be under the licensing and the European Medicines Agency does rigorous testing and safety profiles on biosimilars,” Mr Hanly pointed out.

“With biosimilars, because these are very technical medications manufactured using live organisms, there will be slight differences, there has to be just because of the way they are made. But the EMA ensures through rigorous testing and licensing that the safety profile is met, and that it is as effective as the biologic medicine.

“The technology behind the medicine is quite complicated but this solution of substitution is very simple and we have already shown it to be effective at a pharmacy level through generic substitution.”

Savings According to the IPU, a recent report warned that spending on biologics is expected to reach ¤900 million in 2020.

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Despite several attempts to improve biosimilar use, the report states that uptake remains low and is variable.

Evidence shows that where systems are in place offering biosimilars as a prescribing option, uptake is enhanced.

According to the report, “The uptake rates vary widely both nationally and within hospital groups ranging from 0 to 100 per cent for different hospitals.

Significant efficiencies are being reported in centres where biosimilars were introduced as a prescribing option compared to sites with little or no uptake.”

Pharmacists on the ground broadly support the IPU’s proposal.

According to Kerry based pharmacist, Jack Shanahan, substitution of expensive biologics for cheaper biosimilars “makes sense financially.”

Tomás Conefrey, a pharmacist based in Dublin, agrees.

“Yes it would make financial sense for the government to enable pharmacists to substitute biosimilars…I’m seeing more every month of these products, using less expensive biosimilars, it will make the same money go a lot further,” he said.

Department position According to a Department of Health spokeswoman, it fully supports “domestic policies that maximise efficiency in our medicines usage”.

Efforts are underway to improve uptake of biosimilars, but the spokeswoman declined to comment on the IPU’s proposal on substitution.

“The HSE is actively engaged in implementing effective policy levers across a number of domains and under several initiatives, including programmes under the Acute Hospitals Drugs Management Programme (AHDMP), the Medicines Management Programme (MMP), and within the Primary Care Eligibility and Reimbursement Service (PCERS),” said the spokeswoman.

The AHDMP has a biosimilar strategy in place since 2017.

This is making “considerable progress using a collaborative approach to bring about changes in prescribing practice”.

“The MMP completed an evaluation process in 2019 for the identification of the best-value biological (BVB) medicines for TNF-α inhibitors under the HighTech Drug arrangements. In June 2019, a system of gain-share was introduced and is administered by the PCERS with the objective of encouraging the prescribing of the BVB medicines. This has been largely successful in increasing uptake of these medicines.”

To the end of July, the HSE has estimated savings of ¤30.1 million in 2020 from biosimilar switching initiatives, according to the spokeswoman.

Total expenditure on biosimilar medicines in 2019 was approximately ¤13.4 million, or almost 17 per cent of the available market. To the end of July 2020, this increased to almost 35 per cent.

The statement concluded: “The Department of Health and HSE are continuously monitoring and evaluating the effectiveness of current levers to ensure that the State can capitalise on the most efficient policy approach”.

Do doctors support the proposal?

The Irish Medical Organisation (IMO) declined to state its position on the matter.

Under the IMO GP Agreement from 2019, it is envisaged that the union will enter into discussions with the Department of Health and the HSE on a range of issues around medicine management, safety issues and initiatives to manage resources.

“We have received no proposals from Government on legislative changes that would allow substitution for biosimilars but will of course consider the issues at that time,” confirmed a spokesperson.

23 Dr Laura Durcan, Rheumatologist, Beaumont Hospital, Dublin

“The technology behind the medicine is quite complicated but this solution of substitution is very simple and we have already shown to be effective at a pharmacy level through generic substitution” Dr Laura Durcan, a rheumatologist based at Beaumont Hospital, Dublin, said that she and her colleagues have been “switching” expensive biologics for cheaper biosimilars for some time now.

She stressed, however, that switching a patient onto a biosimilar takes some time, as it is essential the patient is fully informed about their new medication.

According to Dr Durcan, all new patients are prescribed biosimilars and if a patient already on a biologic medicine requires a new prescription, a biosimilar is suggested.

“Patients are generally very accepting of generic switches but they are usually very attached to their biologic medicine and changing their medication can cause some anxiety among patients.”

“I can’t see patients being happy with someone who is not involved in their care changing their medication, some will trust their pharmacists, but all patients will have an established relationship with their doctor and nurse,” said Dr Durcan.

“Each switch is at least a 15 to 20 minute process. There is a good bit of paperwork involved and everything must be discussed with the patient,” she explained.

On whether or not pharmacists should be granted permission to substitute a biologic medicine for a biosimilar, she expressed the view that it is unnecessary.

“It’s not necessary for them to swap medication because we see patients in our clinics every six months and my prescription goes directly to the pharmacy.”

News Praise for ‘Hero’ Pharmacist A heroic pharmacist helped to save a woman's life with a quick-thinking Epipen intervention to stop a potentially fatal allergic reaction.

Clodagh Victory has been hailed by her employer Remedi Pharmacy in Dublin's IFSC after a woman burst into the shop suffering with swollen lips, a swollen throat and breathing difficulties.

Calm Clodagh, who was on duty at the time, administered the lifesaving dose after swiftly snapping into action.

The Trinity College graduate was only just back from Australia, and had very recently started her new job at Custom House Square.

Clodagh took an accurate medial history and learned that the patient suffers from nut allergy and is prescribed EpiPen, which she did not have it with her at the time. Afterwards an ambulance was called and lady in question was taken to hospital. Ambulance staff were back half an hour later to thank Clodagh and informed her than more than likely she saved the girls life!

“I believe Clodagh has shown extreme professionalism and

understanding of procedures while working under extreme stress. It takes a special kind of person to keep their cool and react so well,” said her manager Aneta.

Clodagh Victory, pharmacist, Remedi Pharmacy

PHARMACYNEWSIRELAND.COM

24

News

Winter Flu Vaccinations more important than ever With people across Ireland being more conscious about protecting the health of themselves and their families, Boots Ireland has announced their Winter Flu Vaccination Service will be returning and customers can register their interest now on boots.ie/flu.

Dr Kim Roberts, Assistant Professor of Virology, Trinity College Dublin

more convenient, particularly as the pre-consultation and booking process has been digitised.”

Once customers have registered, they will be the first to hear when online appointment bookings open for the 20/21 season. This year, anyone who falls into one of the HSE at-risk groups for whom vaccination is strongly recommended will be able to avail of the Winter Flu Vaccination Service free of charge.

Commenting at the launch of the service, Dr Kim Roberts, Assistant Professor of Virology,

Trinity College Dublin said, “As Covid-19 continues to be present in Ireland, it is more important than ever for people to consider getting their flu vaccination this year. If we can reduce the level of flu infections this year, it will greatly help the health system, which is under huge pressure as we enter flu season during the Covid-19 pandemic. I have been availing of the flu vaccination service in Boots for years – it couldn’t be easier or

Boots Pharmacist, Susan O’Dwyer said, “Flu has been a topic on lots of people’s minds over the last few months and we understand that people are concerned about the impact of flu season during the pandemic. We want to reassure people that we are here to help.

We have been providing our Winter Flu Vaccination Service in Ireland for 10 years and this year, we have worked hard on adapting the delivery of our service so that it is as safe as possible for our customers and our colleagues.

This year, customers can register their interest from now on boots. ie/flu so that they receive an alert when our online appointment booking system is open.”

The flu vaccination is strongly recommended for those:

• Aged 65 and over • Someone with a long-term medical condition such as diabetes, heart, kidney, liver, lung or neurological disease • Someone whose immune system is impaired due to disease or treatment • Someone with Down Syndrome • Someone with haemoglobinopathies • Someone with a Body Mass Index (BMI) over 40 • Pregnant (the vaccine can be given at any stage of pregnancy) • A resident of a nursing home or another long-stay institution • A healthcare worker • A carer • A household contact to at-risk person • Someone with regular close contact with poultry, waterfowl or pigs

Variations in vitamin D levels Researchers from the Mercer’s Institute for Successful Ageing (MISA) at Trinity College have shown that vitamin D deficiency is widespread across Dublin and surrounding areas in one of the largest studies ever carried out in Europe. The research examined blood levels of vitamin D from 36,466 patients over a five year period (2014 – 2018) and found that 1 in 6 were deficient, rising to 1 in 4 in the winter.

Researchers identified large variations in vitamin D status between adults of different ages and locations. The study found that vitamin D deficiency is a problem for everyone as surprisingly, the youngest participants in the cohort (18-39 yrs category) had the lowest vitamin D levels as did those in the ‘older’ category (80+ yrs).

(including some counties within and outside Leinster) are vitamin D deficient rising to one in four in the Winter indicating a large proportion have inadequate vitamin D status.

4. Vitamin D levels were lowest in the winter, with those living in inner city Dublin and West Dublin having the highest rates of deficiency year round.

Key findings:

2. Young adults (18-39 yrs) were most likely to be vitamin D deficient as were those aged 80+ yrs.

5. While there were more vitamin D tests requested over the five year period, there was no improvement in vitamin D levels in the population.

1. 1 in 6 Irish adults in the Dublin population and surrounds

3. Vitamin D deficiency was more common in men.

Dr Eamon Laird, Senior Research Fellow at the School of Medicine,

Trinity College Dublin said, “Yet again we see more widespread vitamin D deficiency in our population with men, younger adults and the less affluent areas worst affected. This shows vitamin D deficiency is not just an ‘older adult’ problem. Rates of deficiency have not improved therefore education to our identified at risk groups (who are often forgotten) around the importance of vitamin D in the diet is crucial.”

Voices of Pharma Event Following on from the Pharmaceutical Managers Institute (PMI) first event in the Voices of Pharma series on September 10th featuring Professor Martin Curley – HSE, Professor Derek O’Keeffe – UHG & NUI Galway and Dr Frank O’Donnell – Microsoft – the series continues on October 15th.

The event will take place from 12-2pm.

This event will focus on Healthcare Professionals – their experience through Covid-19: How they are continuing to provide care, how the landscape has changed, and how they are now engaging with industry.

The Voice of Pharma Series is sponsored by United Drug.

PHARMACYNEWSIRELAND.COM

VITAMIN

2000IU

3

Contributes to: • maintenance of normal bones • normal function of the immune system • maintenance of normal muscle function MADE IN IRELAND Food supplements should not replace a varied, balanced diet and a healthy lifestyle.

Mylan Ireland, Newenham Court, Northern Cross, Malahide Road, Dublin 17, Ireland. www.mylan.ie Date of Preparation: April 2020 Code: COL-2020-0004

26

News

Signposting for Stoptober All across the world, people are signing up for the Stoptober challenge – to see if they can stop smoking for 28 days.

This offers community pharmacy teams the ideal opportunity to advise smokers visiting the store about the benefits to quitting and the products available to help.

The Stoptober challenge is running for the month of October and is encouraging smokers to try and give up for 28 days, thus making it easier for them to stop in the long run.

47% of smokers will make at least one quit attempt this year.

Smoking is the leading cause of preventable death in Ireland. Each week, over 100 people die from diseases caused by tobacco use; this represents almost one in five of all deaths. In addition, many people live with conditions related to smoking, with people who smoke, on average, losing at least 10 quality years of life.

Top tips for smokers to help them quit:

you want to quit on a postcard and refer to this when you are finding quitting difficult • Set a date you want to start your quit attempt and let your family and friends know this so they can support and encourage you • Tick off each smoke-free day on the calendar as a way of making the person feel good

• Write down all the reasons why

New Partnership for Multiple Myeloma By combining genomic testing and next generation sequencing technology, a new partnership led by RCSI researchers aims to advance predictive tests for multiple myeloma (MM), the second most common blood cancer in Ireland.

Dr Siobhan Glavey RCSI

The study will be carried out at Beaumont Hospital Dublin and run through the Blood Cancer Network Ireland with several other cancer hospitals in Ireland participating.

Predicting the course of the disease and guiding treatment choice in newly diagnosed patients, is one of the major challenges in this cancer and currently available tests at diagnosis fall short of providing this information to patients and haematologists. Newly developed tests over the last number of years are helping to do this and one such example is Minimal residual disease (MRD). This is a test performed on the patients DNA at diagnosis by Next Generation Sequencing (NGS), which can

detect if there are trace amounts of the cancer remaining in a patient after treatment, and has been shown to be highly predictive of long-term outcomes in several studies. Another test that can help to predict patients outcomes has been developed by SkylineDx, which uses a novel gene expression based test to guide prognosis called the “MMprofiler”.

At Beaumont and RCSI, in collaboration with SkylineDx, scientists have implemented these novel gene based tests SkylineDx for the testing of MM patients in order to guide prognosis. This test called “MMprofiler with SKY92” establishes if patients have a high risk of relapsing and has been increasingly adopted

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in global clinical trials as a more predictive and robuster marker than older tests like fluorescence in-situ hybridization (FISH). This study at RCSI and Beaumont aims to combine these two highly predictive modalities to provide a personalized medicine approach for patients.

This in-depth analysis of genetic risk could enable doctors to identify which patients are at highrisk of relapse after a stem cell transplant. With this knowledge, it may in the future be possible to refine treatment for individual patients based on their specific disease molecular signature.

“If our study can definitively determine which patients will benefit from certain treatments, and when, it will provide clinicians with invaluable information that will lead to better outcomes for patients with multiple myeloma.” said Dr Siobhan Glavey, Honorary Senior Lecturer at RCSI, Consultant Haematologist at Beaumont Hospital and the project’s Principal Investigator.

Community pharmacists call to action The approaching seasonal influenza and the resurgence of Covid-19 cases across Europe are going to place an enormous burden on already strained health care services.

Implementing flu vaccination programmes in times of Covid-19 will be particularly challenging and it is urgent to put in place effective vaccination campaigns that can help preventing hospitalisations, ensuring adequate access and uptake of flu vaccines especially for at risk groups.

The PGEU is calling on health care authorities to continue and strengthen collaboration with community pharmacists and pharmacy organisations and integrate community pharmacists into national vaccination strategies.

PGEU President, Duarte Santos, stated: “We cannot stop the coronavirus yet, but we can mitigate the detrimental effects of a combination of Covid-19 and seasonal flu on health systems in the next months.

We strongly encourage national governments to make use of the widely accessible network of pharmacies across Europe.

Community pharmacists are highly trained healthcare professionals and a trusted source of information.

“They can play a key role in identifying patients in at risk groups and increasing public confidence in vaccination.

Pharmacists should be closely involved in the planning of flu vaccination programmes and given adequate support and resources to deliver patient care.

“As front-line health care providers they should also be included in priority access groups for the flu vaccine.”

The Irish Medical Organisation (IMO) has contacted its members over “frustrations” with seasonal flu vaccine delays saying twothirds of the overall supply required should arrive with a pending shipment, with the rest by the end of October.

In a letter they explained that influenza vaccine arrives in a number of shipments, but the initial ones have been delayed, and have brought reduced quantities.

“The HSE is working with the manufacturer to minimise any disruption,” it said.

Contains nicotine

“I quit smoking for her” Fergus O’Shea

Help smokers quit with an

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*Provides significant improvements in quit rates vs patch alone. Stead LF et al. 2012 Nicotine replacement therapy for smoking cessation, Cochrane Library.

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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: Step 1 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 (e.g. those who smoke 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. 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, diabeties, 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: Transient rash, itching, burning, tingling, numbness, swelling, localised pain urticaria, hypersensitivity reactions. headache, dizziness, tremor, sleep disorders, nervousness, palpitations, tachycardia, dyspnoea, pharyngitis, cough, nausea, vomiting dyspepsia, upper abdominal pain, diarrhoea, constipation, dry mouth, sweating, dermatitis, photosensitivity, arthralgia, myalgia, asthenia, malaise, influenza-type illness, fatigue, 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. http://www.medicines. ie/medicine/12136/SPC/NiQuitin+CLEAR+7+mg+24+hours++transdermal+patch/ http://www.medicines.ie/medicine/12137/SPC/NiQuitin+CLEAR+14+mg+24+hours+transdermal+patch/ http://www. medicines.ie/medicine/12138/SPC/NiQuitin+CLEAR+21+mg+24+hours+transdermal+patch/ 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. 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. 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, susceptiblity 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, dyspnoea, vomiting, diarrhoea, GI discomfort, flatulence, hiccups, heartburn, dyspepsia, nervousness, depression, palpitation, rash, angioedema, pruritus, erythema, hyperhidrosis, fatigue, malaise chest pain, anaphylactic reactions, hypersensitivity, tremor, dysgeusia, paresthesia mouth, seizures & epilepsy, dysphagia, eructation, salivary hypersecretion, pharyngitis. http://www.medicines.ie/medicine/14493/SPC/NiQuitin+Mini+1.5mg+mint+lozenges/#PRODUCTINFO http://www.medicines.ie/medicine/14492/SPC/NiQuitin+Mini+4mg+mint+lozenges/ Legal classification: GSL: PA 1186/18/11 & PA 1186/18/12. MAH: Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland.

Pharmacy ‘committed’ to expanded Flu uptake

T

his Winter, more so than any other year, flu vaccinations are vital. Community pharmacists have established themselves within Ireland as being the key providers of this.

According to the National Disease Surveillance Centre's November 2019 Report, the proportion of vaccines administered in pharmacies is increasing year on year since this option was first offered during the 2012/2013 influenza season.

Last season, 41,700 people over 65 were vaccinated in pharmacies, 41% up on 2018, ten times more than in the first year of pharmacist involvement.

This excellent growth rate continues to demonstrate that

the convenience and accessibility of the pharmacy service is highly valued by patients.

However, in the season ahead, there will be a new challenge to overcome when providing the service considering the impact of Covid-19.

Research by LloydsPharmacy shows, almost three quarters (74%) of adults claim that the Covid-19 pandemic has made them more aware of the importance of being vaccinated against viruses, such as the flu,

28 | PHARMACYNEWSIRELAND.COM

with those aged 18-24 (93%) most likely to claim this to be the case.

However, just under half (46%) of adults said that they are planning on getting the flu vaccine this year.

Therefore, it is even more important community pharmacists and their teams advise and educate their customers and patients on the benefits, especially to those in at-risk groups, including those over 65, people with impaired immune systems, those with a BMI over 40, pregnant women, healthcare

workers and carers, cancer patients and many more.

Expansion of Flu Vaccine Minister for Health Stephen Donnelly TD recently confirmed that an expanded flu vaccination programme will roll out this autumn. He also confirmed the extension of GP special payments to ensure Covid-19 consultations remain free of charge to everyone.

As part of Ireland’s plans for living with Covid-19, and in addition to free GP consultations and testing,

Unique formulation Unique formulation

6x faster 6x faster than decongestant pills.*

than decongestant pills.* Recommend Recommend for for blocked runny nose blocked andand runny nose colds fromfrom colds

pratropium Bromide 0.06% metazoline Hydrochloride 0.05% Ipratropium Bromide 0.06% Xylometazoline Hydrochloride 0.05%

ss-specific comparison (topical vs systemic decongestant)

*class-specific comparison (topical vs systemic decongestant) uct Information.

Product vine Extra DualInformation.

Relief 0.5mg/ml + 0.6mg/ml nasal spray, solution (xylometazoline ochloride and Extra ipratropium bromide). treatment of nasal congestion Otrivine Dual Relief 0.5mg/mlIndications: + 0.6mg/mlSymptomatic nasal spray, solution (xylometazoline hydrochloride rhinorrhea in connection with common colds.

Dosagetreatment and method of congestion administration: Adults: in and ipratropium bromide).

Indications: Symptomatic of nasal and rhinorrhea ff in each nostril up tocommon 3 times daily.

6 hoursand min. between 2 doses. Max. 3 puffs daily intonostril up connection with colds. Dosage method of administration: Adults: 1 puff in each h nostril.toMax. 7 daily. days 6use.

Paediatric population: Not for use under years of age.

3 times hours min. between 2 doses. Max. 3 puff s daily into18each nostril.

Max.Geriatrics: 7 days use. ed experience use in patients 7018 years Hypersensitivity Paediatricofpopulation: Not forabove use under yearsofofage. age. Contraindications: Geriatrics: Limited experience of use in patients gredients, atropine substances. After surgical operations whereatropine dura mater may have above 70 yearsorofsimilar age. Contraindications: Hypersensitivity to ingredients, or similar substances. n penetrated.

Patients with glaucoma rhinitis sicca.

UsePatients with caution in patients After surgical operations where duraormater may havePrecautions: been penetrated. with glaucoma or hypertension, cardiovascular diseases, long in QTpatients syndrome, hyperthyroidism, diabetes mellitus, rhinitis sicca.

Precautions: Use with caution with hypertension, cardiovascular diseases, long ertrophyQTofsyndrome, the prostate, stenosis of diabetes the bladder, pheochromocytoma and astenosis sensitivity to bladder, adrenergic hyperthyroidism, mellitus, hypertrophy of the prostate, of the tances.pheochromocytoma Use with caution in patients predisposed to angle closure and a sensitivity to adrenergic substances.

Useglaucoma, with cautionepistaxis, in patientsparalytic predisposed and cystic fibrosis.

Immediate angioedema and rash mayincluding occur. to angle closure glaucoma,hypersensitivity epistaxis, paralyticincluding ileus and urticaria, cystic fibrosis.

Immediate hypersensitivity . duration of use is 7 days toand prevent rebound effect.

Avoidofspraying in ortoaround the eye. eff Side urticaria, angioedema rash may occur. Max. duration use is 7 days prevent rebound ect. Avoid cts: Epistaxis, nasal nasal nasal congestion, dry throat, spraying in or dryness, around thedysgeusia, eye. Side effheadache, ects: Epistaxis, nasaldiscomfort, dryness, dysgeusia, headache, nasal discomfort, at irritation, parasomnia, dizziness,dry tremor, irritation,dizziness, dry eye,tremor, palpitations, nasalrhinalgia, congestion,dry drymouth, throat, throat irritation, rhinalgia, mouth,eye parasomnia, eye irritation, ycardia, ulcer, sneezing, dyspepsia, hypersensitivity.

Overdose: May cause dry mouth, drynasal eye, palpitations, tachycardia, nasal nausea, ulcer, sneezing, dyspepsia, nausea, hypersensitivity.

Overdose: May cause ommodation difficulties and tachycardia. is symptomatic.

Legal category: dry mouth, accommodation difficulties Treatment and tachycardia.

Treatment is symptomatic.

Legal Pharmacy category: Pharmacy Only. y. Product Licence Number: PAPA0678/131/001.

MAH:GlaxoSmithKline GlaxoSmithKline Consumer Healthcare Product Licence Number: 0678/131/001. MAH: Consumer Healthcare (Ireland) Limited, 12 Riverwalk, and) Limited, 12Business Riverwalk, Citywest Business Campus, Dublin 24, Ireland.

Full product information Citywest Campus, Dublin 24, Ireland.

Full product information is available in the SPC. Additionalisinformation is lable inavailable the SPC.upon Additional available request. information Text prepared:isMay 2020. upon request. Text prepared: May 2020. e marks are marks owned or licensed to the to GSK of companies.

PM-IE-OTRI-20-00011 Trade arebyowned by or licensed the group GSK group of companies.

PM-IE-OTRI-20-00011

an expanded flu vaccination programme has been put in place.

This is to protect our society and our health service from any surge in COVID-19 cases occurring at the same time as a spike in flu infections.

The aim of the extended programme is to reduce the overall spread of flu in the community and reduce flu-related hospital admissions through increased vaccination in vulnerable groups.

All of those in at-risk groups, including healthcare workers, will be able to access the vaccination without charge. All children aged from 2 to 12 years inclusive will also have access to vaccination without charges. The vaccine will be administered to children through nasal drops rather than an injection.

Minister Donnelly said, “The health service is entering a challenging winter period, in the midst of a global pandemic. It’s important that we make every effort collectively to limit the impact on the health service over the coming months.

“Limiting the impact and protecting the most vulnerable people in our society means that everyone who can get the flu vaccine should get it, and we are starting by making it accessible without charge to all in the at-risk groups. GPs, pharmacists and their staff have worked incredibly hard to support and care for their patients during this pandemic. The administration of the flu vaccine will be another crucial part of that work.

we enter our first flu season while living with Covid-19.

IPU Secretary General Darragh O’Loughlin said, “The flu led to the hospitalisation of over 4,000 people in Ireland during the last flu season. That is more than were hospitalised with Covid-19, which should be a reminder of the serious nature of the illness. Since the start of the Covid-19 crisis, we have consistently called for a significant investment in this year’s national flu vaccination campaign, to keep people safe from flu and protect our health system from its impact, so we can deal with the continuing impact of Covid-19.

It has been caused by an administrative delay, and not by any issues in the manufacture or quality of the vaccine. The doses for Ireland will be in the first batch of vaccine already released.

It’s important to note that there is no effect on the delivery of the vaccine for children, which is coming from a different manufacturer.

Mr O’Loughlin concluded by reminding everyone to get vaccinated early; “The earlier we all get vaccinated the earlier

we are protecting ourselves, our families and our entire communities. We can’t yet stop Covid-19, but we have a vaccine to stop the flu, and that is everyone’s responsibility.”

The Pharmaceutical Group of the European Union also made calls for community pharmacist action.

In a statement they said last month, “The approaching seasonal influenza and the resurgence of Covid-19 cases across Europe are going to place an enormous burden on already strained health care services. Implementing flu vaccination programmes in times

Symptoms

Flu

Cold

Runny nose or nasal congestion

Rare

Common

Sneezing

Rare

Common

Sore throat

Common

Common

Fever

Common

Rare

Temperatures between 38°C and 40°C Sudden onset

Cough

“The vaccine will be available from your GP or your pharmacist, and I would urge everyone to get the vaccine this winter.”

Separately, there has been a short delay in the delivery of one flu vaccine from the manufacturer.

This delay is likely to be about two weeks, and it affects all customers across the world, not just Ireland.

“There is no doubt that expanding the programme and making the vaccine free to children, as well as everyone in an at-risk group, will save lives. Pharmacists are committed to playing our part and ensuring this expanded availability means expanded uptake nationwide. Last year there were over 1.1 million flu vaccines delivered in Ireland, which is up 60% since pharmacies were first permitted to administer the vaccine a decade ago.”

Headache

Common

Common

Sudden onset

Mild or moderate

Common

Rare

Sometimes intense

Aches and pains

Fatigue

Common

Rare

Sometimes intense

Mild

Common

Common

Intense

Mild

Duration: a few days, sometimes longer

Welcome from Pharmacists Pharmacists welcomed the announcement that the flu vaccination programme will be expanded. The Irish Pharmacy Union (IPU) said it shows the important role flu vaccination will play in protecting our health as

Nausea and vomiting

30 | PHARMACYNEWSIRELAND.COM

Common in children

Rare

Rare in adults

Mild

Often accompanied by diarrhoea and abdominal pain in children

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Convenient spray format Even coverage and no sticky feeling

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Easier to use on children

DiDistributed stributed byby AlAllegro legro

Calpol® Infant & Calpol® Six Plus

Ireland’s No.1 pain & fever reliever*

From fever to blocked noses, Calpol® has got you covered

Lets Kids be Kids MAH: Johnson & Johnson (Ireland) ltd. Airton Road, Tallaght, Dublin 24. Products not subject to medical prescription. Full prescribing information available upon request. Calpol® Vapour Plug & Nightlight is an electrical device and non-medicine. CALPOL® Saline Nasal Spray, CALPOL® Saline Nasal Drops and CALPOL® Blocked Nose Spray are medical devices for congestion relief. *IMS May MAT Units 2020 (For Calpol® Infant and Calpol® Six Plus medicinal products)

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of Covid-19 will be particularly challenging and it is urgent to put in place effective vaccination campaigns that can help prevent hospitalisations, ensuring adequate access and uptake of flu vaccines especially for at risk groups.

“PGEU calls on healthcare authorities to continue and strengthen collaboration with community pharmacists and pharmacy organisations and integrate community pharmacists into national vaccination strategies.”

PGEU President, Duarte Santos, stated, “We cannot stop the coronavirus yet, but we can mitigate the detrimental effects of a combination of Covid-19 and seasonal flu on health systems in the next months. We strongly encourage national governments to make use of the widely accessible network of pharmacies across Europe to assist in efficient immunisation strategies and broaden vaccination opportunities.

“Community pharmacists are highly trained healthcare professionals and a trusted source of information. They can play a key role in identifying patients in at risk groups (elderly, patients with chronic diseases, immunocompromised etc.) and increasing public confidence in vaccination. Pharmacists should be closely involved in the planning of flu vaccination programmes and given adequate support and resources to deliver patient care.

As front-line health care providers they should also be included in priority access groups for the flu vaccine.”

The Pharmacy Service The number of people turning to over-the-counter cold remedies continues to increase year-onyear. Sales of decongestants, lozenges and cough mixtures are also rising.

With increasing encouragement from GPs not to attend practices for common seasonal symptoms, it is more important than ever for pharmacists to stock a wide range of products. Consumers can then treat cold and flu symptoms at home rather than visiting their GP. By their nature, winter remedies are often a distress purchase bought when consumers are already feeling unwell and looking for fast and effective relief for the symptoms. Stocking all the products for different ages and becoming familiar with the product range will ensure pharmacists can provide the best self-help advice.

During this time of year, many patients are likely to seek advice regarding the proper selection to treat and manage the symptoms generally associated with the

common cold and the seasonal flu. For many patients, especially those taking prescription medications and those with other medical conditions, the selection of OTC products is overwhelming. Pharmacists can be an indispensable resource when it comes to aiding patients in the selection and proper use of these products and can also refer patients to seek further medical care from their GP when warranted.

When speaking to customers, pharmacists may also be able to help patients in distinguishing between cold and flu symptoms (Table 1, on page 30), and they should always seize this opportunity to remind patients about the safety and efficacy of the annual flu vaccination.

Common Cold The term “common cold” is widely used to describe an upper respiratory tract infection of viral origin. Adults in general suffer from cold approximately two to four times annually while children can contract the virus three to eight times as their immune systems aren’t as developed.

Distinctive symptoms means that people often diagnose and treat themselves through a combination of self-care and OTC products, without needing to go to the doctor. If there is no improvement then an appointment with a doctor should be arranged. A GP can do an investigation to rule out whether the symptoms are being caused by a more serious infection, such as pneumonia or glandular fever.

All members of staff should be trained up on when to refer a patient for further medical attention, especially if they present with cold or flu-like symptoms that are accompanied by any of the following: high fever, vomiting, a non-blanching rash, photophobia, severe headache and/or confusion. Children presenting with high-pitched screaming, floppiness, bulging fontanelle, convulsions or stiff neck should go straight to A&E. There is no cure for a cold, but certain measures can be taken to improve comfort levels while the virus dissipates: decongestants, antihistamines and pain relievers might offer some relief from symptoms however they won't stop a cold from developing and will not shorten its duration.

Vitamin C is useful for people in high risk groups who are at high risk of colds due to frequent exposure — for example, nurses or pharmacy staff. Echinacea and Zinc may also benefit patients during the cough and cold season.

Flu In the majority of healthy people, the flu is unpleasant. Symptoms such as fever, headaches, coughs, muscle aches and pains can suddenly occur and last up to seven days or a fortnight in some cases.

Other groups are at-risk of harmful or even life-threatening complications from the flu, particularly those with compromised or developing immune systems, including pregnant women, the elderly, and young children.

Boost your flu vaccination service: • Advertise – use window posters and leaflets to highlight your service and attract customers

• Engage the entire pharmacy team – ensure all your staff understand the key differences between your private and the HSE service • Get the team to talk about the vaccine and offer it to all eligible customers so they can refer into the service • Have a robust booking system – create a system that works for you and your pharmacy, either a diary or an electronic booking system. Book appointments for quieter times, and when your pharmacy is well staffed.

• Manage your stock – good stock management is key to a profitable service. Ordering in larger quantities often means you get stock at a better price, but over-ordering can result in unused stock that has to be written off as out of date.

Managing Cough During winter, most coughs are caused by viruses such as colds and flu and can be safely managed at home using OTC remedies. Coughs are classified as “acute” or “chronic”. An acute cough is most common and lasts up to three weeks. It’s usually caused by a cold or flu virus and most improve after one to two weeks.

Chronic cough lasts for eight or more weeks. The most common causes include acid reflux, asthma, TB, COPD, bronchitis and smoker’s cough.

Red-flag signs include: • Coughing up blood • Unexplained weight loss • Night sweats • Cough worsening after three weeks • Shortness of breath • Voice changes • Lumps/swellings in neck • Chest pain Dry or chesty cough?

A dry cough is caused by inflamed airways due to a viral infection such as a cold or flu. A chesty cough produces phlegm. This is caused by the lungs producing extra fluid due to an infection.

It is important to get a detailed overview of the patient’s symptoms.

Is their cough productive? How long have they had the cough and what action has been taken? Pharmacists should ask if a patient has any medical conditions that may affect any treatment or product you recommend.

The Right Medicine The role of cough medicine is to ease symptoms while the body heals.

There are many brands of OTC cough medicines. But there are only three basic types: Expectorants help thin mucus, making it easier to cough up. The ingredient is guaifenesin.

Suppressants help cut the number of times someone coughs. The active ingredient listed is usually dextromethorphan (DM). Other cough suppressants include camphor, eucalyptus oil, and menthol.

Combination cough products have more than one active ingredient.

They have both guaifenesin and dextromethorphan. Cough medicines may also contain ingredients to help coat and soothe the throat.

Combination products may have medicines to ease other symptoms, that may include decongestants for stuffy nose, antihistamines for allergies or a runny nose, or painkillers.

Cough drops can also help relieve a cough and may ease a sore throat.

PHARMACYNEWSIRELAND.COM | 33

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

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

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

35° C 30° C 25° C

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

20° C 15° C 10° C 5° C

35° C

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

30° C 25° C 20° C 15° C 10° C 5° C

Cold hands and feet?

This problem may be a result of having poor blood circulation, and the solution could be tablets with ginkgo biloba.

Every inch of the body depends on a wellfunctioning blood supply that delivers oxygen and nutrients to the cells. As we humans age, our blood circulation becomes less efficient, leading to problems like cold hands and feet.

Supports your blood circulation It stands to reason that ginkgo biloba is so popular among older people. The active compounds in the extract dilate your blood vessels, helping your blood to flow more easily through them.

What is ginkgo biloba?

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

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

IE_Biloba_Ad_IrishPharmacyNews_210x297_0920

Ginkgo-Biloba Pharma Nord has a high content of active compounds: The high content of active compounds makes it possible to obtain the desired effect with 1 tablet twice a day.

Traditional herbal medicinal product used to alleviate the symptoms of poor blood flow in conditions such as cold hands and feet, exclusively based upon long-standing use. Always read the leaflet.

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

Winter Remedies

35

Winter, MacGyver and the Gargle?

Prologue: With winter almost upon us, it's time to dust off recent research and take a look at some (mostly) long-established pharmacy products.

Prologue: With winter almost upon us, it's time to dust off

recent research and takeListerine a look at some Mouthwash (mostly) longis 10%), Original (a mix of Essential Oils) and tap water and compared established pharmacy products.

I’ve a friend in Sweden, a paediatrician and Winter, Gargle and MacGyver

them to a non-gargling control group. Gargling researcher. Hans Kollberg also has a keen was performed three times daily for 3 minutes.

Winter, Gargle and MacGyver interest in nutrition and, well, everything else.

I’ll add the caveat that the Listerine forms in His rural neighbour is an organic egg producer.

Ireland have changed a bit from the original Together they started inoculatingI’ve chickens with in Sweden, a friend a paediatrician and researcher. formulation and the product website makes no a variety of human infections that are awkward claims of efficacy against in COVID-19.

Hans Kollberg also has a keen interest nutrition and, to treat (due to drug resistance). From the eggs, they harvested the resultingwell, antibodies However, the results are still intriguing.

After one everything else. His rural neighbour is an organic egg (known as IgY, the chicken equivalent of human week, the iodine (Betadine) group had almost producer. Together they started inoculating chickens with IgG) and made specific throat gargle vaccines.

100% elimination of virus from throat swabs, a variety infections that group are awkward tothe treat Pseudomonas aeruginosa is a leading driverof human the Listerine Original 80% while water of hospitalization in Cystic Fibrosis so that was garglers still managed 20% versus 0% for (due to drug resistance). From the eggs, they harvested chosen for the first trial of IgY. Sure enough, non-garglers. Obviously, this is a pilot trial but the resulting antibodies (known as theblue. chicken daily gargling led to significant reduction in it’s not completely outIgY, of the Betadine the rates of infection and hospitalisation (and of human already hadand clinical dataspecific demonstrating equivalent IgG) made throatthe gargle associated annual treatment costs). efficacy of gargling against gonorrhoea and vaccines. The anti-Pseudomonas aeruginosa gargle was that it is virucidal. Ongoing research will likely As you’ll know, that’s a pretty big deal in broaden the gargling options.

Onecystic trial is pitting trialled as a daily prophylaxis in patients with CF. However, it has proved impossible to Betadine against Hydrogen Peroxide and Neem attract the funding for an international launch. fibrosis.

Ps aeruginosa one of the has leading drivers of extract. is And betadine also been proposed Major pharmaceutical firms need the certainty for use as a nasal irrigation for healthcare hospitalization and antibiotic courses in CF patients. Sure of a patent. workers. Whatever your poison, gargling enough, daily gargling led to highly significant reduction in seems a beneficial measure to dislodge and/or I was reminded of this immutable law of drug the rates of infection and hospitalization (and annual inactivate infectious agents seeking to infect via development again this week while reading the throat. a pilot study on gargling for COVID-19 treatment costs). containment. More on that below.

In the same vein, my colleagues in Gorey you’ll know, that’s a pretty deal in CF. However, are users of Irishbig Botanicals’ Throat Coat, a it We’re facing into a unique winter.As Last year’s herbal throat spray the with funding marshmallow, sage, flu vaccine had 4 strains and record hasuptake. proved impossible to attract for an fenugreek, liquorice and osha root, which our The HSE and health professions beat the drum. international launch.

Major pharmaceutical firms needand the anecdotal experience suggests can relieve Why? Because the flu season in Asia and nip throat infections in the bud.

Australia had been especially deadly.

Some of certainty of a patent. those who swear they had COVID last winter Vitamin D: While lots of data showed that deep likely had a touch of one of theseI swine-flu was reminded of this immutable drug with more deficiency of Vitamin law D is of associated related flus. However, as mentioned in an earlier severe infection (and more pain and development again thisCOVID-19 week while reading a pilot study article, COVID-19 was also making its first ill health in general), it didn’t prove cause and appearance in Ireland then. I’ve detected strong on gargling for COVID-19 Morethe ondisease that or effect. Did containment. deficiency aggravate anti-COVID IgG levels in one man who was sick vice versa? This makes a recent pilot study from below. over Christmas.

Spain all the more interesting. Two matched of COVID-19 patients were randomly This year, you could argue that the flu vaccine We’re facing intogroups a unique winter. Last year’s flu vaccine assigned to Vitamin D supplementation or – again a 4-in-one – is partly being used for had 4 strains and record uptake.

The HSE and not. Both groups also received thehealth hospital’s diagnostic purposes. Physical distancing and treatment protocol – in thisflu case masks should reduce the spread professions of flu too. Butbeatstandard the drum. Why? Because the season hydroxychloroquine and azithromycin. The nobody wants to be treated for COVID when it’s in Asia and Australia had been especially deadly.

Some of Vitamin D used was 25-hydroxyvitamin D. This severe flu. Or vice-versa. And worry about the is they the form the supplements our had shelves prospect of two viruses fighting over ourwho body.swear those hadthat COVID last winter on likely a (Vitamin D3) get converted into in the body – Like our customers, we’ll be looking to nip touch of any one of these related flus. and theswine-flu form that blood tests useHowever, to measureas emerging infection in the bud - before having to Vitamin Darticle, status. That aside, the results were mentioned in an earlier COVID-19 was also making think about diagnosis or, heaven and hell forbid, eye-opening. The treated group of 50 patients its first appearance in Ireland then.

I’ve detected strong a nose and throat swab. Way back in the 1980s, had just one ICU admission (2%) versus 50% there was a TV detective called MacGyver for the in untreated. anti-COVID IgG levels one man who was sick over who was a great little recycler. No matter the This supports supplementation – with the usual predicament, he’d make good hisChristmas. escape by micronutrient caveat. As with diabetics and repurposing what he found in his vicinity into their insulin there an appropriate range tools or weapons. All without ruffling mullet.

Thishis year, you could argue dose, that the fluis vaccine – again a 4of blood and tissue levels for micronutrients.

COVID-19 has put us in his shoes. We’re in-one – is partlyExcess beingoften usedhas forsimilar diagnostic purposes. effects to deficiency. re-discovering the power of soap, and Physical of decades-old research into masks and distancing and masks should reduce the spread of International best practice is to know the antiseptics. Are there are other items in theBut nobody flu too. wants to be treated for supplementing COVID when Vitamin D level before you start pharmacy that might have new meaning this and to check after 12 weeks to see if the it’s severe flu. Or vice-versa. And worry about the prospect winter season? calculated dose was too low, too high or just of two viruses fighting over our body. right. While it’s easier to get testing than in the Throat gargles: Sadly these aren’t my friend past, it’s not always easy to get the follow-up Hans’s egg extracts. A recent study in Malaysia Like our customers, we’ll to field nip any emerging check.

My be ownlooking anecdotal researches on took COVID-positive but asymptomatic patients Vitamin D (backed by published and had them trial 3 different types of throatin the bud infection - before having to think data) aboutsuggest that most Irish people are deficient with an gargle: Betadine Mouthwash (Povidone Iodine and hellnot forbid, nose and(those throat average score far offa40nmol/L in 1% - not on the market here; the diagnosis ULM importor, heaven

swab. Way back in the 1980s, there was a TV detective called MacGyver who was a great little recycler. No matter the predicament, he’d make good his escape by

Some COVID updates:

Some COVID updates:

Our standard anti-COVID measures such as was Our standard anti-COVID measures and all the more suchmask-wearing as washing andare mask-wearing areimportant in all the importantstudy in the which light of tried a light ofmore a Hungarian measurin Hungarian study which tried measuring pressure needed toto burst the pressure needed burstthe theSARS-2 SARS- (COVID-19 2 (COVID-19) with (image a (nano-)credit needleProf Miklos with a (nano-)virus needle (image credit Prof Miklos Kellermayer, Kellermayer, Semmelweiss University, Budapes Semmelweiss University, Budapest).

But…it burst.Even Evenwhen when squeezed so on But…it didn’t didn’t burst. squeezed so one side of the virus It just bounced of the virus touched the other. touched the other. It just bounced back.

Even 100attempts. attempts. a divil!

Even after after 100 It’sIt’s a divil!

There was to (60 ˚C for There was similar similarresilience resilience to (60 ˚C for an hou an hour). Some spikes were damaged Some spikes were damaged but it was still esse but it was still essentially infective. infective.

And new Korean research on community spread in the city of Daegu has shown

And Korean research oncases community sprea that new completely asymptomatic hadcity similarly high viral the of Daegu hascounts showntothat completely symptomatic cases. As pessimists asymptomatic cases had would have it - assume the similarly worst andhigh viral cou you won’t be disappointed.

Masks rule. symptomatic cases. As pessimists would have i assume theI worst and you Fugaku won’t be disappoint Last month cited Japanese supercomputer Masks rule. simulations which had

shown that a surgical mask intercepts almost all droplets on the way out (e.g.

Last cited Japanese Fugaku supercomp if themonth wearer Icoughs) and that even a double-layered cotton willthat a surgical ma simulations which had mask shown catch up to 80%. Fugaku (as reported intercepts almost all droplets on the way out (e in the Guardian newspaper) has now the wearerclear coughs) even examined plasticand facethat visors anda double-lay found that they don’t prevent cotton mask will catch up toescape 80%. Fugaku (as of droplets, infectious or otherwise. reported Guardian has now However, in thethe funnel effect atnewspaper) least changes their direction, which is some examined clear plastic face visors and found th comfort if you’re face to face with a don’t prevent droplets, visored patient.escape Less of of a comfort if infectious or the wearer isHowever, making your otherwise. thelunchtime funnel effect at least sandwich at the deli counter. Make changes their and direction, which is some comfort that a toasted microwaved sandwich please. you’re face to face with a visored patient. Less

comfort if the wearer is making your lunchtime sandwich at the deli counter. Make that a toast and microwaved sandwich please.

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Winter Remedies

poor health are generally lower again). The Sufficient range for Vitamin D is generally agreed as 75 – 125 nmol/L. Molloy’s Pharmacy Group in the West helped me run a trial of Vitamin D testing in summer in Galway some years back. Despite 2 months of good weather, working people tended to be low. To have sufficient levels you needed to be a healthy and active retiree. I’ve also found that it takes about a fortnight’s holiday in the sun (in the Med rather than Bundoran) to have levels around 120nmol/L. For this winter, if we assume most are starting at or below 40nmol/L a D3 dose of around 3000IU per day should be fine till Spring. But levels should be checked at some stage.

Children: COVID will be an ever-present fear this winter, both for children and any relatives they meet. Parents will also worry than the first signs of a cold could lead to children being sent home, or for testing.

Based on the no-harm principle, what can we offer parents for their children as “tonics” and to boost immunity? We have some very decent multivitamin brands.

As with most micronutrients, I advocate them as top-up courses rather than for daily ongoing use. Stressful times (e.g. the Christmas excesses, exams or illness) are situations where they should be considered.

When looking to boost the immune system, paediatric Echinacea is no more (but is, thankfully for adults). But we do have the likes of extracts of elderberry as sambucus nigra (e.g.

Sambucol). Research showed it could prevent attachment and replication of coronaviruses that are closely related to the agent triggering COVID-19. As a result, sambucus has been advocated as a preventative, but – since it increases cytokine release – not for treatment.

Dr Dílis Clare, a GP and herbalist based in Galway, has been

producing Kinderkind Syrup (Dr Clare’s Apothecary) for some years. It can be used from one year of age and contains Mallow leaf, Sambucus Berries, Limeflower, Elderflowers, Rosehips, Chamomile, Icelandic Moss, and Hyssop Herb, a mix of active botanicals for winter infections.

Moving towards the grown-ups, there has been a lot of discussion of the role of intracellular zinc in immune modulation and potential prevention and attenuation of COVID-19 infections. Zinc also plays a massive role in enzyme systems involved in repair, glucose metabolism and growth. Regular supplementation over months might affect absorption of other micronutrients (e.g. copper, manganese). However, short term use is fine. If taking zinc lozenges, the anecdotal naturopathic advice has been that if they leave a long-lasting metallic taste, your levels are already high. A diet high in meats and vegetables will generally provide decent levels of zinc. It’s also in lentils and beans. Organ meats like liver are particularly strong and there’s even some in porridge.

Quercetin, also found in onions and apples, helps push zinc into cells and this is considered important for COVID resistance.

Earlier in the year, I’d written about therapeutic use of Vitamin C in infections. I’d mentioned liposomal (e.g. Porebski, Altrient C and other brands) forms as boosting Vitamin C levels beyond the usual. I was hoping there would be published results of high dose Vitamin C trials (usually injected) in COVID-19 by now, but they are still ongoing. There are anecdotal case report reviews (i.e. no control group) suggesting safety and reduced severity of disease.

Ailments aggravated by cold: Chilblains are one of those awkward conditions that present in pharmacy, usually in elderly patients. Products like Pickle’s Chilblain Ointment tended to

come and go over the years and we never really had a good range of therapeutic options. Most products for chilblains contained a heater-upper like methyl salicylate or other essential oil, along with some moisturizing and anti-friction ingredients. My newfound interest is due to recent publications about patients presenting with chilblains as a primary symptom of COVID-19, especially younger patients. So we’ll take a look at chilblains and some related symptoms that are aggravated by cold weather.

Chilblains typically afflict extremities, hands, feet, ears and nose and arise in response to exposure to cold. They are caused by inflamed blood vessels and present as itch, pain and red-purple swelling (see picture).

They sometimes blister. As with Raynaud’s (see below), standard treatment involves avoiding the cold, wearing warm clothes, and if that fails, sometimes Rx-nifedipine.

I can’t help but think chilblains would be given more respect if referred to by the technical term - perniosis.

Treatment overlaps with Raynaud’s Phenomenon or Raynaud’s Disease, an excessive vasoconstriction that happens on exposure to cold. It leads to blanching and numbing of the affected parts. It can feel like having an inanimate digit or limb and can last for hours. The sudden re-opening of microcirculation afterwards can also be very uncomfortable.

Before considering Rx meds, we have a few front of shop and nutritional tools to try. Nitric Oxide is the body’s vasodilator.

Arginine is one source (hence its popularity some years back as a supplement for hypertension and “poor circulation”). Nitric Oxide is also readily made from nitrates in root vegetables like beetroot. One County hurling nutritionist told me that her lads add beetroot powder to their protein shakes for the week before a big game to increase flow and oxygen supply to muscles.

For conditions like Raynaud’s or chilblains it likely takes regular use to make a difference.

Another intriguing option is gingko biloba. I mainly remember gingko as an aid to cognitive function.

Gingko nuts were also a tasty addition to winter foods in Korea.

When I worked in Seoul, gingko leaves were being exported to West Cork for extraction. For many years, the resulting gingko extract was the top prescribed drug in Germany for patients who had suffered stroke or vascular dementia. Based on its mode of action, it was also successfully

PHARMACYNEWSIRELAND.COM

trialled in Raynaud’s Disease (versus placebo) and the emphasis was on using it regularly to reduce the number of flare-ups.

PharmaNord is now specifically marketing a Gingko supplement for this indication.

A further overlapping condition is cold-induced cholinergic urticaria. There’s a well-liked pharmacist in South Dublin (let’s call him L) who often kicks lumps out of me at soccer. God’s punishment for him (I agree, it’s disproportionate) is a form of cold-induced urticaria which strikes when the temperatures fall.

In the past, he’d sometimes have to leave the pitch in mid-game or avoid playing at all. Symptoms of cold urticaria can range from skin rashes (a bit like heat rash) to anaphylactoid reactions that involve circulation. As it’s largely histamine-mediated, higher doses of non-sedating antihistamines now allow L to play through the winter season. Ouch.

References on request 1. Kiss B, Kis Z, Pályi B, Kellermayer M. Topography, Spike Dynamics and Nanomechanics of individual native SARSCoV-2 virions. bioRxiv [Internet]. 2020 [cited 25 September 2020];. Available from: https://doi.org/10.1101/2020.09.17.302380.

2. Zeng W, Wang X, Li J, Yang Y, Qiu X, Song P et al. Association of Daily Wear of Eyeglasses With Susceptibility to Coronavirus Disease 2019 Infection.

JAMA Ophthalmology. 2020 (cited 27 September 2020); 3. Mohamed NA, Baharom N, Sulaiman WSW, Rashid ZZ et al, Viral Clearance Among Covid-19 Patients When Gargling With Povidone-Iodine and Essential Oils: A Pilot Clinical Trial. MedRxiv 2020.09.07.20180448; doi: https://doi. org/10.1101/2020.09.07.20180448 4. Khan F, Kazmi S, Iqbal N, Iqbal J, Ali S, Abbas S. A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial.

Trials. 2020;21(1).

5. Kirk-Bayley J, Challacombe S, Sunkaraneni V, Combes J. The Use of Povidone Iodine Nasal Spray and Mouthwash During the Current COVID-19 Pandemic May Protect Healthcare Workers and Reduce Cross Infection. SSRN Electronic Journal. 2020; 6. Colunga Biancatelli R, Berrill M, Catravas J, Marik P. Quercetin and Vitamin C: An Experimental, Synergistic Therapy for the Prevention and Treatment of SARS-CoV-2 Related Disease (COVID-19). Frontiers in Immunology. 2020;11.

7. Cheng R. Can early and high intravenous dose of vitamin C prevent and treat coronavirus disease 2019 (COVID-19)?.

Medicine in Drug Discovery. 2020;5:100028.

8. Hiedra R, Lo K, Elbashabsheh M, Gul F, Wright R, Albano J et al. The use of IV vitamin C for patients with COVID-19: a case series. Expert Review of Anti-infective Therapy. 2020;:1-3.

9. H Muir A, Robb R, McLaren M, Daly F, Belch J. The Use of Ginkgo biloba in Raynaud's disease: a double-blind placebocontrolled trial. Vasc Med. 2002;7(4):265-7.

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Call: 051-271010 | Email: info@macuhealtheurope.com | Web: macuprime.ie References: 1. Enrichment of Macular Pigment Enhances Contrast Sensitivity in Subjects Free of Retina Disease: Central Retinal Enrichment Supplementation Trials – Report 1, Nolan et al, IOVS, 2016. 2. The Impact of Supplemental Antioxidants on Visual Function in Nonadvanced Age-Related Macular Degeneration: A Head-to-Head Randomized Clinical Trial” Akuffo, et al IOVS, 2017. MacuPrime PLUS contains Zinc which contributes to the maintenance of normal vision. Food Supplements should not be used to replace a health balanced diet and lifestyle.

CPD: Eye Care

Continuing Professional Development

CPD

39

This module is suitable for use by community pharmacists as part of their Continuing Professional Development. After reading this module, in the magazine or online, complete the post-test on our website at www.pharmacynewsireland.com and include in your personal CPD ePorfolio.

AUTHOR BIO: Jacqui Murray is a pharmacist with experience in both hospital and community settings. She studied with the IPU to qualify as a pharmacy technician, where soon after made the transition to studying pharmacy in UCC. Since graduating in 2017, she has continued to work in a community setting, gaining valuable experience as both a support and relief pharmacist. Writing for a health publication such as IPN, is a new venture, one that has allowed her to combine her interest in both research and pharmacy.

Management and Treatment of Eye Conditions

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Planning - Will this article satisfy those knowledge gaps or will more reading be required? What resources are available?

Eye Conditions

60 Second Summary For both adults and children, the pharmacy is often the first point of contact in seeking advice on new or chronic eye symptoms.

Serious eye conditions such as age-related macular degeneration (AMD) is the leading cause of sight loss in Ireland in people over the age of 50. Recent research carried out on people with AMD in this age bracket and living in the Republic of Ireland, showed an estimated overall prevalence of over 7%.

Dry AMD, the more prevalent of the two, is caused by the slow progressive atrophy of the retinal pigment epithelium (RPE), a monolayer of cells located beneath the photoreceptor cells in the retina whose function is to nourish these cells and to remove waste products.

Conjunctivitis is the inflammation or infection of the conjunctiva, a thin translucent membrane that covers the anterior surface of the sclera and the inner surfaces of the eyelids.

Allergic conjunctivitis can be seasonal or perennial and occurs when the eyes come into contact with an allergen such as pollen, animal dander or dust mites.

Infective conjunctivitis, subdivided into bacterial and viral, usually affects both eyes but can begin in one with symptoms developing in the second eye within 24-48 hours.

Dry eye syndrome is one of the most common ocular conditions worldwide with prevalence rates as high as 57.5%.

A survey carried out by the PSI, found that 58% of the population surveyed attended the pharmacy frequently, 47% sought advice first from a pharmacist on a medicine and a further 25% would seek general healthcare advice from their pharmacist.

The pharmacy is often the first point of contact in seeking advice on new or chronic eye symptoms in both adults and children. Many of the symptoms seen in allergic conjunctivitis or dry eye for example are treatable with over the counter products but recognising when to refer for further examination is important.

Action - After reading the article complete the summary questions at www. pharmacynewsireland.com/cpdtraining and record your learning for future use and assessment in your personal log.

Age-Related Macular Degeneration (AMD) Serious eye disease such as AMD, is the leading cause of sight loss in Ireland in people over the age of 50. Recent research carried out on people with AMD in this age bracket and living in the Republic of Ireland, showed an estimated overall prevalence of over 7%.1

Evaluation - How will you put your learning into practice?

Have I identified further learning needs?

The macula, which is located at the central retina and appears as a yellow pigmented spot, is responsible for central and spatial vision providing the ability to see fine detail such as reading, writing and facial recognition.2 AMD affects central vision over time but typically peripheral vision remains intact and can be classified as either early or late with the latter further subdivided into dry or wet. In early AMD, eye sight is not affected and signs of retinal damage are only visible upon examination, hence the importance of having regular eye tests, putting pharmacies in a prime position to counsel patients on keeping up regular visits to an optometrist.3

destruction of the photoreceptors and detachment of the RPE.4, 2, 3

Dry AMD, the more prevalent of the two, is caused by the slow progressive atrophy of the retinal pigment epithelium (RPE), a monolayer of cells located beneath the photoreceptor cells in the retina whose function is to nourish these cells and to remove waste products.

In dry AMD, deposits made up of lipids and proteins, known as drusens build up leading to deterioration of the photoreceptors necessary for vision. Wet AMD can develop rapidly, resulting in severe loss of vision but is less common. It is caused by the formation of abnormal new blood vessels (neovascularisation), which can leak blood and fluids resulting in retinal scar tissue,

Increasing age, hypertension, a poor diet and lack of exercise are all risk factors in developing AMD. Smoking has shown to be the most consistent modifiable risk factor in developing AMD and pharmacists are in a good position to provide counselling to patients on smoking cessation therapies and educational resources to enable patients to quit. Studies have shown that people who have a family history (a parent or sibling) of AMD can place them at a greater risk of developing AMD and therefore should have their eyes checked regularly. However, it does not mean AMD will definitely occur as various environmental factors as well as genetic factors are implicated in its development.5

Published by IPN. Copies can be downloaded from www.irishpharmacytraining.ie Disclaimer: All material published is copyright, no part of this can be used in any other publication without permission of the publishers and author.

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CPD: Eye Care

In the early stages of AMD, patients may experience only minimal blurring of their central vision. A blind spot can develop where progress tends to be slow in dry AMD but more rapid in wet AMD. Other symptoms include distortion of vision, where straight lines appear wavy or crooked, difficulty in recognising faces, requiring a brighter light to read, difficulty in reading and driving, reduced contrast and changes in the way colour is seen. It is also possible for dry AMD to progress into wet AMD and any sudden changes in vision patients should seek immediate medical assistance.3 Currently there is no treatment for dry AMD. As progression tends to be slow, improving a patient’s quality of life through the use of low vision aids is important to help alleviate concerns of potential loss of independence e.g. hand-held magnifiers and lamp magnifiers to name but a few. Patients may find it helpful to source these through low vision clinics or their optician, where the most appropriate aids can be recommended.

Supplementation with ocular nutrients, discussed in greater detail below, has shown to be effective in AMD at improving vision and this is something their doctor will most likely include in their management plan.

Antiangiogenic drugs are used to slow progression of wet AMD. The VEGF (Vascular Endothelial Growth Factor) inhibitors, ranibizumab and aflibercept, prevent VEGF-A (and other growth factors in the case of aflibercept) from binding to their receptors thus preventing endothelial cell proliferation, neovascularisation and vascular leakage, all of which are implicated in wet AMD.6 Both medications are delivered via intravitreal injection at monthly intervals. Ranibizumab is continued until there is maximal improvement in visual acuity and no changes in other signs

or symptoms of the disease. After three consecutive months aflibercept is spaced out to bimonthly due to its greater half-life.7, 8 Several clinical trials have shown that ranibizumab can improve visual acuity in over 90% of patients, however since there is currently no prevention for the development of AMD and these treatments are used in management of wet AMD, early detection is key as well making changes to known modifiable risk factors such as smoking.

The macular pigment (MP) which is concentrated in the foveal region of the eye is composed of the carotenoids, lutein (L), zeaxanthin (Z) and meso-zeaxanthin (MZ). The MP functions to absorb blue light, act as an antioxidant and it has been suggested that low MP density at the centre of the macula could be a risk factor in developing AMD which may be due to a decrease in its functional ability.9 L and Z must be obtained from the diet and are commonly found in dark green leafy vegetables and orange or yellow fruits and vegetables whereas, MZ which is the dominant macular carotenoid, is primarily formed through isomerisation of lutein.10 MP profiles or concentrations can vary between individuals and a study carried out in healthy individuals showed that atypical profiles were more common in patients with established risk factors for AMD (smoking and increased age).9 Age-related eye disease studies (AREDS) carried out on supplementation with L and Z in combination with antioxidants showed an increased benefit in reducing the risk of progression to advanced AMD. Interestingly upon addition of omega 3 fatty acids, neither harmful nor beneficial effects were found, however, other research shows a potential benefit especially if a patient’s diet is low in fish intake and supplementation products often contain omega 3 fatty acids.11 Supplement

40 | PHARMACYNEWSIRELAND.COM

comparison studies have consistently shown that when MZ was added, a superior and more efficacious response was achieved than in the L and Z groups alone. A large and recent RCT found that participants who received all three carotenoids experienced greater clinical improvement in their vision upon trial completion when compared to the group not receiving MZ.12 Conjunctivitis Conjunctivitis is the inflammation or infection of the conjunctiva, a thin translucent membrane that covers the anterior surface of the sclera and the inner surfaces of the eyelids. It acts as a physical barrier to prevent microbes from entering and works to lubricate the eye by secreting mucin from its goblet cells which form a part of the tear film. Conjunctivitis, depending on presenting symptoms can be either allergic or infective.13, 14 Allergic Conjunctivitis (AC) Allergic conjunctivitis can be seasonal or perennial and occurs when the eyes come into contact with an allergen such as pollen, animal dander or dust mites. Symptoms occur in both eyes and include generalised redness which extends to the inner surface of the eyelids. Other symptoms of AC include sore, itchy, watery eyes and swelling of the eyelids.

Patients may experience associated symptoms of allergic rhinitis such as a runny or blocked nose and sneezing.15 Treatment of AC typically involves the use of OTC eyedrops that contain either an antihistamine or a mast cell stabiliser.

Antazoline, an antihistamine is found in combination with xylometazoline, a sympathomimetic that constricts the blood vessels to reduce redness. It is recommended for rapid relief of the initial symptoms of the allergic reaction but not intended for use

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Macular Degeneration

longer than seven days due to the risk of rebound hyperemia16 and is licensed for use in adults and children over 12 years. Use is contraindicated in patients with glaucoma and in patients receiving treatment with monoamine oxidase inhibitors or within 14 days of stopping such treatment.17 Sodium cromoglicate, a mast cell stabiliser can be use prophylactically while exposed to the allergen. It does not provide rapid relief from the symptoms but can be effective at controlling symptoms over a longer period of time and is suitable for use in adults and children although data is limited to the recommended minimum age of use. Patients should avoid rubbing the eyes as this can cause mast cell degranulation and worsening of the symptoms. Other counselling points include; the use of wrap-around sunglasses in reducing exposure to the allergen and using a cool compress or lubricating eye drops to help to ease symptoms.18, 19 Infective Conjunctivitis (IC) Infective conjunctivitis, subdivided into bacterial and viral, usually affects both eyes but can begin in one with symptoms developing in the second eye within 24-48 hours. Causative bacteria include, S.aureus, S. pnuemoniae and H.influenzae and adenovirus accounts for a high percentage of cases of viral conjunctivitis.19 Presenting symptoms can help to distinguish between the two but often times this can be difficult to do. A white-yellow mucopurulent discharge is typically present in bacterial conjunctivitis whereas with viral cases, the discharge tends to be watery. A gritty, sore feeling can be a symptom of both and lubricant eye drops can be used to help ease the discomfort. Sometimes in cases of viral conjunctivitis there may be associated cold-like symptoms such as a sore throat, temperature

and a cough. Both types of infection are typically self-limiting but topical antibiotics have been shown to reduce duration of infection in bacterial conjunctivitis and can be prescribed if symptoms are not resolving or worsening.20, 21 At home management is important in easing symptoms and preventing further infection.

Patient’s should be advised to: • wash their hands thoroughly after any contact with the eyes • use their own face cloths/towels • avoid touching the eye with any eye drop preparation as this can contaminate the product and contribute to further spread of the infection.

• gently cleanse the eye with cotton wool soaked in cooled boiled water to remove sticky discharge.

• remove contact lenses until all signs and symptoms of infection have gone and for at least 24 hours after a course of topical antibiotics.

Broad spectrum topical antibiotics typically prescribed in bacterial conjunctivitis include chloramphenicol drops or ointment and fusidic acid drops. Transient blurring of vision can occur after use of ointments and in some cases with drops and patients should be advised not to drive just after administration. They can also cause some local burning or a stinging sensation. Topical antibiotics should be continued for 48 hours after the eye appears normal.

A patient should be referred to their doctor if their symptoms are not improving or they experience any of the following: • true pain in the eye as opposed to a gritty feeling

• redness localised around the pupil • photophobia and disturbed vision such as haloes around objects • loss of/reduced vision.19 In situations where a person presents with a child under 28 days old with symptoms of infective conjunctivitis such as a sticky discharge and redness, these patients should be referred to their GP to rule out the possibility of a more serious infection.22 Dry Eye Dry eye syndrome is one of the most common ocular conditions worldwide with prevalence rates as high as 57.5%. Symptoms of dry eyes can develop when the tear film, which is composed of three main components or layers, experiences a loss of homeostasis due to a number of factors. Dry eye syndrome can be classified as aqueous deficient (a decrease in tear production) or evaporative (when tears evaporate quickly) but patients can experience both.

Numerous factors are implicated in dry eye syndrome: • use of contact lenses or certain types of lenses • computer or device use where blinking may be less frequent which can result in evaporation of tears • a smoky or air conditioned environment • use of certain medications e.g. anticholinergics and isotretinoin • hormonal changes

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CPD: Eye Care [Internet]. 2018 Feb 1;2018:8374647. Available from: https://pubmed.ncbi.nlm.nih.gov/29484106 7. Novartis. Lucentis 10mg/ml solution for injection [Internet]. EMC. 2019. Available from: https:// www.medicines.org.uk/emc/product/307/ smpc#PHARMACOKINETIC_PROPS 8. Plc B. Eylea 40mg/ml solution for injection in a vial. EMC. 2020.

9. Nolan, John M; Akkali, Mukunda C.; Loughman, James; Howard, Alan N.; Beatty S. Macular carotenoid supplementation in subjects with atypical spatial profiles of macular pigment. Exp Eye Res. 2012;101:9–15.

10. Meagher, Katherine A; Thurnham, David I; Beatty, Stephen; Howard, Alan N; Connolly, Eithne; Cummins WNJM. Serum response to supplemental macular carotenoids in subjects with and without age-related macular degeneration. Br J Nutr. 2013;110:289–300.

Symptoms of dry eye include: • a stinging or burning feeling • a gritty sensation like there is something in the eye • excessive watering and redness.

Symptoms for referral include; associated dryness of mouth and other mucous membranes and outward turning of the l ower eyelid.

Preservatives in eyedrops can sometimes cause irritation and worsen the symptoms of dry eye, therefore single dose unit preparations that are preservative free may be a more suitable alternative, especially if frequent dosing is required e.g. greater than 6 times per day. Prescribing guidelines indicate that in cases with mild to moderate symptoms requiring treatment of less than 6 times per day, patients can begin with products containing hypromellose, PVA or carbomer depending on preference. Due to the viscosity of carbomer, it is recommended to use this product after administration of any other eyedrops the patient may be using.23 In situations where symptoms are severe, products that contain sodium hyaluronate which has a longer residency time in the eye may be a better choice. These products are also preservative free making them more suitable for frequent dosing if required or if the patient has an intolerance/allergy to the preservatives.

Lubricating eye ointments are useful for use at bedtime due to their longer retention time and propensity to blur vision.24 Non-pharmacological treatments include good eye hygiene, taking regular breaks from computer work and blinking the eyes more frequently. Some patients may also have blepharitis, an inflammation of the eyelid margins, where in addition to the symptoms of dry eye they can also experience itching and burning of the lid margins with skin flakes around the lashes.

A survey carried out by the PSI, found that 58% of the population surveyed attended the pharmacy frequently, 47% sought advice first from a pharmacist on a medicine and a further 25% would seek general healthcare advice from their pharmacist.25 These figures illustrate the important role pharmacy plays in helping patients with minor ailments such as some of the eye conditions listed above but somewhat more importantly our knowledge of serious eye conditions can influence a patient to seek further investigation if perhaps that was not their initial intention, thus allowing patients to receive timely and effective treatments.

References 1. Akuffo KO, Nolan J, Stack J, Moran R, Feeney J, Kenny RA, et al. Prevalence of age-related macular degeneration in the Republic of Ireland.

Br J Ophthalmol [Internet]. 2015/02/23. 2015 Aug;99(8):1037–44. Available from: https:// pubmed.ncbi.nlm.nih.gov/25712825 2. Mathenge W. Age-related macular degeneration.

Community eye Heal [Internet]. 2014;27(87):49– 50. Available from: https://pubmed.ncbi.nlm.nih. gov/25918464 3. Choices N. Age-Related Macular Degeneration [Internet]. www.hse.ie. 2011. Available from: https://www.hse.ie/eng/health/az/a/amd/treatingmacular-degeneration.html 4. Kolb H. Simple Anatomy of the Retina. Webvision Organ Retin Vis Syst [Internet]. 1995;1–24.

Available from: http://www.ncbi.nlm.nih.gov/ pubmed/21413391 5. Deangelis MM, Silveira AC, Carr EA, Kim IK. Genetics of age-related macular degeneration: current concepts, future directions. Semin Ophthalmol [Internet]. 2011 May;26(3):77–93.

Available from: https://pubmed.ncbi.nlm.nih. gov/21609220 6. Hernández-Zimbrón LF, Zamora-Alvarado R, Ochoa-De la Paz L, Velez-Montoya R, Zenteno E, Gulias-Cañizo R, et al. Age-Related Macular Degeneration: New Paradigms for Treatment and Management of AMD. Oxid Med Cell Longev

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11. Hobbs RP, Bernstein PS. Nutrient Supplementation for Age-related Macular Degeneration, Cataract, and Dry Eye. J Ophthalmic Vis Res [Internet]. 2014;9(4):487–93.

Available from: https://pubmed.ncbi.nlm.nih. gov/25709776 12. Nolan J. CREST AMD Trial:Vision Improvement Among Patients with AMD Who Consue Xanthophyll Carotenoids. Optom Manag. 2018; 13. Shumway, Caleb L; Motlagh, Mahsaw; Wade M. Anatomy, Head and Neck, Eye Conjunctiva.

StatPearls [Internet] [Internet]. 2019; Available from: https://www.ncbi.nlm.nih.gov/books/ NBK519502/ 14. Roat MI. Overview of Conjunctival and Scleral Disorders. Merck Man. 2019; 15. Roat MI. (Atopic Conjunctivitis; Atopic Keratoconjunctivitis; Hay Fever Conjunctivitis; Perennial Allergic Conjunctivitis; Seasonal Allergic Conjunctivitis; Vernal Keratoconjunctivitis). MSD Man. 2019; 16. Spector, S.L.; Raizman MB. Conjunctivitis Medicamentosa. J Allergy Clin Immunol.

1994;134–6.

17. Ltd TP. Otrivine Antistin Eye Drops. EMC. 2019.

18. Choices N. Conjunctivitis, allergic. www.hse.ie.

2011.

19. Rutter P. Community Pharmacy Symptoms, Diagnosis and Treatment. Third. Churchill Livingstone Elsevier; 2013. 43–59 p.

20. Choices N. Conjunctivitis, infective. www.hse. ie. 2011.

21. Epling J. Bacterial conjunctivitis. BMJ Clin Evid [Internet]. 2012 Feb 20;2012:704. Available from: https://pubmed.ncbi.nlm.nih.gov/22348418 22. Mallika P, Asok T, Faisal H, Aziz S, Tan A, Intan G. Neonatal conjunctivitis - a review. Malaysian Fam physician Off J Acad Fam Physicians Malaysia [Internet]. 2008 Aug 31;3(2):77–81. Available from: https://pubmed.ncbi.nlm.nih.gov/25606121 23. Punyer J. Ocular Lubricant Prescribing Guidelines. NHS Rotherham CCG Ocul Lubr Guidel. 2015; 24. Snibson, Grant. R; Wilson, Clive G; Bron AJ. Ocular Surface Residence Times of Artificial Tear Solutions. Cornea, Res. 1992; 25. Ireland TPS of. Public Survey- Attitudes to Pharmacy in Ireland. www.thepsi.ie. 2016.

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Listen Up!

Ear Care Management in Pharmacy

P

harmacy management of ear conditions moves sharply into pharmacy focus during the winter months, with customers looking for advice about treating the whole range of symptoms of a winter cold or virus. Along with everyday illnesses, some concerned customers may also visit a pharmacy to ask for advice about conditions such as tinnitus, and more common ear infections.

There are a plethora of common ear complaints that people will present to their pharmacy with. Ear infections are a usual occurrence with most children experiencing at least one, whilst record numbers of the population are being diagnosed with hearing loss.

Given the importance of this category, the below article takes a brief look at some of the conditions you and your pharmacy team are likely to encounter and how you can help those affected.

Hearing Loss In Ireland alone, over 300,000 Irish adults have a moderate or greater hearing loss, yet only one in five of these have never sought treatment.

Almost 250,000 Irish people have untreated hearing loss which is strongly associated with increased rates of depression, cognitive decline and loneliness.

Hearing loss can be present from birth due to genetic or developmental abnormalities, or arise through trauma, disease or loud noise exposure during the lifetime of an individual. The degree of hearing impairment can vary from mild to profound and causes significant social and personal difficulties.

Recent studies have indicated a connection between untreated hearing loss and dementia.

There are two main types of hearing loss.

Sensorineural Hearing Loss Sensitive hair cells inside the cochlea, or organ of hearing, are damaged, either naturally through ageing or prolonged noise exposure. Quite often a person suffering with this type of hearing loss will not recognise that they have a problem due to their

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hearing deteriorating over a very long period of time. Sensorineural hearing loss can also result from ototoxicity. Certain types of medication can have a toxic effect on the cochlea and vestibular system in the inner ear and result in hearing loss.

Conductive Hearing Loss When sounds are unable to pass from the outer ear to the inner ear, often as the result of a blockage, such as earwax or a build-up of fluid in the middle ear cavity a hearing loss will result. Head trauma with resulting ossicular chain dislocation, Otosclerosis, or excessive bone growth in the middle can also result in a conductive hearing loss.

Sometimes both types of hearing loss occur at the same time, this is known as a mixed hearing loss.

This occurs when someone has

a combination of sensorineural and conductive hearing loss.

This results in a disruption to the transmission of sound through the outer and middle ear as well as damage to the hair cells in the inner ear.

Hearing loss in children The total instances at school entry of unilateral (in one ear) and bilateral (in both ears) mild to profound hearing loss is thought to be of the order of 1 to 2 per 1,000; that means between 3,000 to 4,500 preschool and school age children in Ireland will have a permanent hearing impairment, with potential consequences for education, communication, literacy, social and emotional development, and later employability.

The Health Service Executive now run the Newborn Hearing Screening Program to identify

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than for adults because of the risk of long-term effects. If it is affecting a child’s hearing, it can in turn delay their speech and language development.

In all patients with persistent or recurrent glue ear, secondary care monitoring is often required, where surgical insertion of grommets to drain the fluid and restore air flow through the ear might be recommended.

Importantly, pharmacists should be mindful that antihistamines and decongestants should not be recommended to patients with glue ear.

Ottis Externa is the inflammation of the skin lining the outer ear.

This can be the cause of a trauma to the skin, an infection or a skin allergy.

Symptoms include an itchy ear, a discharge from the ear canal and pain in moving the jaw. In some extreme cases, ottis externa can lead to a reduction in hearing. If the infection is severe an antibiotic may need to be prescribed. moderate, severe and profound hearing impairments in newborn babies. Newborns identified with a hearing difficulty have a better chance of developing speech and language skills and of making the most of social and emotional interaction from an early age.

Consultation rooms themselves can also help people with hearing loss to concentrate on what the pharmacist is saying, without distracting background noise.

Clear signage enables people to know they can speak to the pharmacist in these areas.

Pharmacists can help to tackle the issue by spotting hearing problems, educating people about the symptoms and causes, and advising people about where to go for help. As well as discussing the dangers of exposure to loud noise, pharmacists can warn about trauma – for example, making sure that people buying items such as cotton buds know they should not be inserting them into their ears.

Ottis Media is an inflammation of the middle ear and is often associated with sore throats, colds or other respiratory issues where the infection spreads to the middle ear. It is very common in children.

Research suggests people do not seek help for hearing problems until 10 years after they start, meaning they may miss out on treatment or help. But pharmacists can pick up a great deal simply by observing their patients' behaviour.

For example, you may notice that when you speak to them, they tend to look at your mouth in order to follow the conversation.

Many people don’t even realise they are lip reading because of hearing problems.

With so many people living with hearing loss, pharmacists need to consider how best to optimise communication in their pharmacy to accommodate them.

One option to support hearing aid users is a hearing loop system.

This provides a magnetic, wireless signal that is picked up by hearing aids when they are on the right setting. A small microphone at the counter picks up spoken words, and the loop system amplifies it into the patient’s ear.

The patient can suffer from temporary hearing loss and pain or discomfort in their ear. Patients can avoid ottis media by getting their annual flu vaccination. Ottis Media usually happens very quickly for a short duration. If the patient has had the symptoms for a few weeks or month it may be an acute ear infection and should visit their doctor. Antibiotics are usually prescribed as treatment.

The pharmacy can offer pain relief with ear drops or antihistamines if the inflammation is causing discomfort.

If customers are prescribed ear drops or use OTC products, it is important they are shown how to use them properly and reminded that ear drops should be discarded 28 days after opening.

Ottis Media with effusion (OME) or glue ear is very common in young children. It is a build up of fluid and causes hearing loss in one or both ears. In some instances the condition can lead to an infection of the ear if it is not treated. Glue ear is caused by the eustachian tube not working effectively by neglecting to drain the ear of fluid.

In young children, the case can be made for GP sooner

46 | PHARMACYNEWSIRELAND.COM

However a patient should be advised to avoid using cotton buds and treat the area with an ointment or ear drops. Also advise customers to keep their ears dry.

This will help to stop bacteria from entering the ear canal.

Tinnitus is a ringing or buzzing in the ears that comes from the inside of the body rather than an external source. In some cases it can be very severe and affect a person’s daily life. Occasionally a build up of earwax is the cause of tinnitus or it may occur because of a blow the head or loud noises.

Patients who work in noisy environments such as musicians or publicans would be susceptible to the condition which will present as a ringing or buzzing in the ear or occasionally a low frequency noise.

Sinusitis is characterised by the inflammation of the lining of the paranasal sinuses. 80% of cases of sinusitis will resolve itself in 14 days. Symptoms of a sinus

infection are a green or yellow mucus discharge from the nose and severe facial pain around the cheeks, eyes or forehead.

Sufferers should be advised to use nonsteroidal anti-inflammatory drugs (NSAID) or paracetamol to ease their pain from their headache, and systemic or topical decongestants to improve air circulation & mucus drainage. If someone has persistent sinusitis after 14 days they should be advised to visit their GP as this is a warning sign of chronic sinusitis and be the result of a bacterial infection or an allergy.

Ear Wax - Earwax helps to protect, clean and lubricate the ears and usually falls out of the ears on its own. Some people are prone to excessive amounts of earwax, which can cause pain, itching and sometimes hearing loss. Excess earwax can often be treated with OTC eardrops to soften the wax so that it falls out more easily – and pharmacists are ideally placed to offer treatment advice before customers visit a GP. Customers will often see a pharmacist first, as this is easier and more accessible than making an appointment with a GP. Olive oil, sodium bicarbonate and OTC earwax products may help to loosen the wax and ease the symptoms. It is important to ask the right questions, however, to check that the customer has excess earwax, rather than anything more serious, and they should be referred to their GP if they have any pain in the ears or the hearing loss is substantial or continues.

It is important that pharmacists ask a series of initial questions with the aim of confirming or eliminating wax as the cause of the problem, before considering whether it might be something else.

Those questions would typically be aimed at eliciting whether the patient has any discharge, acute pain or hearing loss. If they don’t have discharge or pain, but it’s affecting their hearing, then the likelihood is it will be ear wax.

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HIV

“Learn, unlearn, relearn” Written by: Barry O'Sullivan MPSI MBA Senior Pharmacist, Pharmacy Department, Mater Private Hospital, Cork

you are open to change, you are more likely to grasp the mettle and go for it. Understandably, I had concerns about what the work would be like, being a full time Hospital Pharmacist and fixating on what I didn’t know, but in reality there was much that I did know.

My classmates all took a moment to absorb what Tech leader and Irish woman Anita Sands had just said. We were sitting in a function room of a San Francisco bar at lunchtime on a May week day in 2017. We were there as part of our studies on the Corporate MBA program with the University of Limerick.

Amongst other items, she was discussing the idea of having several careers, in differing roles rather than being a careerist in one segment. This was a concept which resonated strongly with me. Six weeks previously I had accepted a new position, leaving Community Pharmacy for Hospital Pharmacy.

Community Pharmacy was to this point all I knew and had experienced. Summer and term holidays from university I worked in a Pharmacy in Mallow.

My pre-registration year was a Community placement. All of my working career to that point was Community Pharmacy but I was eager for a new challenge.

was the relationship-building with regular patients. The Community Pharmacist has a really unique, high-contact position in the landscape of primary care. Over the years I was involved in delivery of pharmacy services to a wide number of Nursing and Residential care units. I derived great satisfaction providing these key pharmacy services, as it gave me a chance to flex my clinical skills. Detailed patient reviews with the medical and nursing teams, and tailoring medications to the patients and their needs was why I became a Pharmacist. Site visits to discuss medications with nurses and patients were very similar to what I do now in the Mater Private Hospital, Cork where I have been for over three years.

I certainly have learnt a great deal over the years working in the sector, but it was time to unlearn some of the administrative aspects of the Community Pharmacist role.

It was time to commence a journey of relearning, moving my focus back to key areas of pharmacology and physiology.

The opportunity to move came about when my then employer, Sam McCauley Chemist group, asked me to provide additional Pharmacist support with the contract delivery in the Mater Private Hospital, Cork. For a number of years Sam McCauley’s Chemist group had provided the pharmacy services with on-site Pharmacist cover and off-site dispensing. In later years, with the marked success and expansion of services in the state-of-the-art facility, the contract was brought in-house and the Pharmacy Department of the Mater Private Hospital, Cork went live at the end of March 2020.

For me one of the most enjoyable aspects of Community Pharmacy

There was never going to be a perfect time to move but when

PHARMACYNEWSIRELAND.COM

Introspection in the time around the sectoral move threw up plenty of points for consideration such as not having a clinical diploma and no prior experience in hospital. To aid in the integration process, I did a lot of self-guided study, refreshing knowledge around absorption, distribution, metabolism and excretion of medications. I spoke to colleagues in other hospitals and leant on the support of the Pharmacy team members. Never be afraid to ask for help or direction.

In both sectors of pharmacy there are commonalities and transferrable skills. Clear communication, evidence-based decision making and team playing will aid greatly in problem solving.

The centre of what we do as Pharmacists is the patient, and we always strive to do our best for them.

Pharmacists are expertly skilled in research skills and communication.

We do it all the time, day in, day out, regardless of role or sector.

We translate technical information to understandable and relatable data, appropriate to the recipient.

The learning curve at times felt almost vertical but there is an exhilaration to that too. Fuel to mental fire.

COVID-19, additional complexities were added, and a greater level of infection control measures are the daily reality for the foreseeable future. For a few months, the type of patient cohort changed in the hospital in line with HSE needs and so knowledge of different types of patient care was required.

A typical day for me is a mixture of chart reviews, patient counselling, clinical staff education, medication queries and aiding in discharge planning from a medication perspective. These were all the expected aspect of the job coming in the door, but additionally there is a wide number of governance committees to do policy and procedural work for. These committees are responsible for a variety of aspects of patient care such as the CPR committee, to the main medication committee: Drugs and Therapeutics. This multi-disciplinary committee has overall governance of medication use with the sole focus of optimal patient care.

Private hospitals in Ireland operate to the standards of Joint Commission International. Their tri-annual routine inspection is preceded with a lot of work across the committees and wider hospital.

Pharmacy has a significant part to play in all this so there is of protocol writing, auditing and training around this too.

Over the years I have been lucky enough to tutor some really excellent Intern Pharmacists and I make sure I explain the logic and process I follow to the students under my tutelage. Regardless of sector, the key messages have been the same: clear communication, robust processes and keeping the patient at the centre of all your activities. Again these are commonalities for all Pharmacists.

Pharmacists are a versatile and adaptive profession; with treatment guidance constantly changing, coupled with stock supply and legislative changes, we have to be.

My days in the Mater Private Hospital, Cork are busy and demanding. Working across all departments, I provide, along with my Pharmacy Department colleagues, the best care we possibly can.

With the success of the Mater Private Hospital Cork in recent years, the future holds many exciting expansion plans.

The addition of new specialities and units will see the Pharmacy department challenged in a positive way to support this growth.

The pace can be quite fast and the work very varied in hospital. With

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Ireland’s newest Pharmacy Buying Platform IndePharm Ltd., the Buying Group behind the Haven Pharmacy Group, has launched an innovative buying platform which aims to revolutionise purchasing in Irish pharmacies.

The new platform – IndeGo Plus – has been in operation in Haven’s 49 pharmacies for the last 12 months where it has had a significant impact on the Group’s performance. The system is the first of its kind as it interacts directly with the pharmacy dispensary system and automatically orders the best priced product that is in stock. Uniquely, it offers its users flexibility and control over ordering and can be tailored to suit each pharmacy’s individual needs and it ensures that consistency in ordering no matter who places the order, so margins are always maintained.

Daragh Connolly, IndePharm’s Chairman, said that IndeGo Plus was developed as a result of the challenges that pharmacies are facing today – time pressures, decreasing HSE payments, stock shortages and pressure on margins.

“IndeGo Plus goes a step further in maintaining consistency of product and saving time whilst ensuring gross margins maximised even if the pharmacy owner is not there” them maximise their buying potential and increase their margins at a critical time in the industry,” added Darragh.

Maria Kenyon, IndePharm’s Commercial and Finance Manager, commented, “We have been buying since 2008 and have always punched above our weight in terms of gross margin in the pharmacy industry. IndeGo Plus goes a step further

“IndeGo Plus has proven its worth to our pharmacies by taking the hard work out of ordering and has improved our gross margin and now, we are very excited to share IndeGo Plus with pharmacies across Ireland.

“We understand that pharmacies have different needs so a ‘one size fits all’ approach to purchasing does not suit everyone. With IndeGo Plus, pharmacies have an input into how product selections are made so pharmacies get the products they want.”

“We are very excited to share IndeGo Plus with pharmacies across Ireland and to help

in maintaining consistency of product and saving time whilst ensuring gross margins are maximised even if the pharmacy owner is not there.

“We understand what is important to both our customers and pharmacies and we have designed IndeGo Plus so that the different needs are catered for without compromising on margin.”

The Review of the Irish Pharmacy Sector for 2019 reported that the pharmacy sector has continued to experience significant economic pressure and that it is essential for pharmacists to maximise all revenue and profit generating opportunities.

“Now, more than ever, pharmacists need to focus their time on their patients and their teams. They need to be confident that they are ordering the right products at the right cost as efficiently as possible.

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Topic Team Training – Migraine Medication A community pharmacy environment that fosters teamwork ensures high levels of consumer satisfaction.

This series of articles is designed for you to use as guide to assist your team in focusing on meeting ongoing CPD targets and to identify any training needs in order to keep the knowledge and skills of you and your team up to date.

The most common symptoms of Migraine without Aura include; Intense throbbing headache, usually on one side of the head, worsened by movement and lasting from 4-72 hours; Nausea, sometimes vomiting; Sensitivity to light; Sensitivity to noise and, Blurred vision.

Migraine with Aura refers to a range of neurological disturbances that occur before the headache begins, usually lasting about 20-60 minutes. About 20% of people with migraine experience ‘aura’ in addition to some or all of the symptoms of ‘Migraine Without Aura’.

The disturbances are usually visual e.g.

• Blind spots The below information, considerations and checklist provides support to enable you to run a team training session and identify opportunities for learning within the topic of Migraine.

Migraine is a primary headache disorder, meaning that it is not caused by another illness. Drug treatments for migraine vary from person to person. They are given to either stop and attack or to prevent attacks. Patients with frequent and severe headaches often require both approaches.

Data suggests that between 12-15% of Irish people suffer from migraine – this means that roughly half a million people suffer from migraine in Ireland. It is estimated that migraine costs Irish businesses ¤252 million every year as a result of lost productivity with the average migraineur

missing between 1.5 and 4.5 days from work annually. Despite these staggering figures migraine remains a misunderstood and under managed condition.

All age groups suffer. Children as young as twelve months have been diagnosed. Three times more women than men suffer mainly due to hormonal changes. People who are subject to migraine come in a large variety of shapes, ages, temperaments and personalities.

Migraine is hereditary in approximately 60% of cases.

The majority of migraine sufferers have Migraine without Aura. The most common symptoms of Migraine without Aura are: Intense throbbing headache, usually on one side of the head, worsened by movement and lasting from 4-72 hours.

• Flashing lights • Zig-zag patterns Approximately 1% of migraineurs experience migraine aura without ever having a headache.

Basilar migraine is a rare form of migraine that includes symptoms such as loss of balance, double vision, blurred vision, difficulty in speaking and fainting. During the headache, some people lose consciousness.

When people with episodic migraine begin to get more frequent and severe headaches, they often increase their use of acute pain medication to deal with it. However, if taken too often, pain-relief medication can itself lead to a type of chronic daily headache called Medication Overuse Headache (MOH)

Key Points: Consider:  We consider our skills in communication with customers suffering from headache

Check your pharmacy team are aware and understand the following key points:

The body gets used to the medication, then craves more.

When the drugs wear off, a headache is triggered which causes the person pain and leads him/her to take more medication.

This leads to a vicious cycle of taking medication to get rid of a headache that is caused by taking the medication.

The headache is usually on both sides of the head, with pain that gets worse and then eases. It’s associated with fatigue, nausea, vomiting, and restlessness.

Preventative medications will be less successful in treating migraine if the person has MOH. The Migraine Association of Ireland recently published a Medication Overview.

Acute medication is given to relieve or stop an attack.

Preventative Medication is given to reduce the frequency and severity of attacks.

It’s important for sufferers to be aware that medications won’t prevent attacks altogether and won’t cure migraine.

Learning www.migraine.ie – The Migraine Association of Ireland Actions:  Include POS with associated condition treatments such as asthma and other allergies  Ensure efficient sign posting to further help and advice or reputable sources for allergy testing  Keep products merchandised together, along with related products such as inhaler guides, to help build sales

 Our advice is holistic

 Migraine is a primary headache disorder

 We continue to learn from our customers to help us provide the best information on managing headache

 The different types of migraine

 My pharmacy assistants are able to meet the points in this training checklist.

 The impact of migraine on work, school and leisure

 Is the pharmacy workstation well set up to avoid eye strain?

Could you improve it?

 The issues around Medication Overuse Headache

 Ensure that I know the recommendations for each OTC treatment depending on the allergy

 Key advice on managing or preventing an attack

 Train the team to meet all the above considerations

 Do you stock any topical products for headache?

Do you know enough about them? Do you recommend them and on what occasions?

52 | PHARMACYNEWSIRELAND.COM

 Ensure that this important category is fully stocked at all times and merchandising plans are amended based on seasonal time of year

The complete range of pain relief

Paralief Range Pain Relief - Full prescribing information is available on request. For retail sale through pharmacies only.

THE STATED DOSE SHOULD NOT BE EXCEEDED. Please refer to the individual product Summary of Product Characteristics.

PA Holder: Clonmel Healthcare Ltd., Clonmel, County Tipperary: Paralief 500mg Tablets - Contains paracetamol PA 126/20/1 (24 pack size) Paralief Hot Lemon 600mg Powder for Oral Solution in Sachet - Contains paracetamol PA 126/20/6 Paralief 500mg Effervescent Tablets - Contains paracetamol PA 126/20/4 PA Holder: Chanelle Medical, Loughrea, County Galway: Paralief Sinus Tablets - contains paracetamol and pseudoephedrine hydrochloride PA 688/34/1 Paralief Night Film-coated Tablets - Contains paracetamol and diphenhydramine HCl PA 688/38/1 Paralief Extra Film-coated Tablets - Contains paracetamol and caffeine PA 688/50/1 For more information go to www.clonmelhealthcare.ie. Date prepared: September 2020 2020/ADV/PAR/079H

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Perspectives

Taking the Road less travelled My journey to becoming a PhD Student Edel Burton, UCC SPHeRE Collaborative Doctoral Programme in Chronic Disease Prevention PhD Scholar 2020-2024 tells IPN readers about her learning journey If you asked me five years ago what I wanted to do when I qualified as a Pharmacist, I would have said “a PhD”. Now five years later, having completed a Bachelors and Masters of Pharmacy, here I am doing just that. My PhD journey is beginning. The hard work has paid off. My dream has come true. My prayers have been answered.

Edel Burton

Why do I want to do a PhD? My passion for research has been there from a young age. I have always questioned why things are how they are, or how could they be improved upon. I was Chairperson of a national allergies and anaphylaxis campaign at the age of 16, inspired by my brother’s multiple food allergies, and from then on doing a PhD was my primary career goal. I realised first hand the difference research can make to the lives of everyday people, and that led me on the journey I am pursuing today.

In essence, I have always been motivated by helping others.

Identifying a problem and striving to find a solution. A PhD will allow me to answer questions society needs answered. I will be able to invest time into potentially making a difference both nationally and internationally.

Across the 3 sectors I have worked in: community, research and hospital Pharmacy I have seen how research has shaped practice and vice versa. I have witnessed how patient outcomes

have been improved due to evidence based decisions and evidence based programs and policies being applied by a multidisciplinary team. It is my goal to be part of this process, and to be involved in this type of cutting edge research.

How did I go about doing a PhD? Everyone’s PhD journey is different. In my opinion you need people, perseverance and preparation to secure a PhD position. I was lucky enough to have the support and guidance of outstanding academic mentors from early on in my Pharmacy career. People who opened doors for me, reviewed applications and directed me towards opportunities. I spoke to current PhD students, and those who have completed PhD programmes I applied for. I also relied on my family for support, and interview preparation. That leads me onto the process of applying for a PhD. Depending on the PhD you are applying for, and the associated discipline, the application process for most PhD positions involves a written

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“I have always been motivated by helping others; identifying a problem and striving to find a solution. A PhD will allow me to answer questions society needs anwered” application and an interview for those who are shortlisted. PhD interviews, like all interviews require prior preparation. My interview varied from academic questions, to personal questions to those based on statistics, and was on Zoom, reflecting the times we live in. I say perseverance is needed, because there are a lot of applications, there is a lot of work to acquire a PhD position, but it is so worth it. They say it is your own motivation and passion for the subject that gets you through a PhD, but that is also true for getting you to the PhD!

What will I be doing for the next four years?

I am now a SPHeRE (Structured Population and Health- services Research Education) Collaborative Doctoral Programme in Chronic Disease Prevention (PhD) Scholar (CDP-CDP). I am one of six scholars accepted onto this programme nationally.

The programme focuses on prevention of chronic disease across the lifespan and across the spectrum from wellness to disease, using the most common chronic diseases in Ireland as the research focus. This programme aims to make graduates future national and international leaders in evidence - based chronic disease prevention research, research implementation and policy development. I will have the opportunity to complete a national placement relevant to my research in Year 2 and an international placement in Year 3. I will also complete mandatory and elective SPHeRE modules, educating me on topics from statistics, to health policy to systemic reviewing.

The programme also advocates presenting at 4 national and 3 international conferences during my PhD. It also advocates for each PhD student to publish at least 2 open access publications over the 4 years.

There is an emphasis on transdisciplinary teams within the CDP-CDP consortium. I am very fortunate to have a highly skilled and highly regarded multidisciplinary supervisory team, who have years of both academic and clinical experience.

I have seen the importance of effective multidisciplinary and transdisciplinary teams in practice, and look forward to working within a consortium of directors, partners, associated partners and trainees from varied backgrounds and areas of expertise. I look forward immensely to the next 4 years.

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Precautions: Avoid concurrent use with other paracetamol-containing products. Diagnosed liver of kidney impairment. Patients on concomitant treatment with drugs that induce hepatic enzymes. Patients with depleted glutathione levels or chronic alcoholism or sepsis. Avoid excessive caffeine intake. Caution in those with hereditary sugar intolerance or on a low sodium diet. Should not be used in pregnancy or lactation without medical advice. Do not exceed the stated dose. Prolonged use except under medical supervision may be harmful. If high fever, or signs of secondary infection occur or if symptoms persist for longer than 3 days, consult your doctor. Side effects: See SPC for full details. All very rare: Thrombocytopenia, hypersensitivity reactions including anaphylaxis and skin rash, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, bronchospasm, hepatic dysfunction. Frequency unknown: Nervousness, dizziness. When combined with dietary caffeine intake, higher doses of caffeine may increase potential for caffeine related adverse events such as insomnia, restlessness, anxiety, irritability, headaches, GI disturbances and palpitations.

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Pain

Musculoskeletal Conditions and Pain The International Classification of Disease includes more than 150 musculoskeletal conditions affecting muscles, bones, joints and associated tissues within the locomotor system.

Written by: Federico Grechi, M.P.S.I., MBA Supervising Pharmacist, Boots Pharmacy Ireland

maladaptive repair responses, including inflammatory pathways of innate immunity.

The disease clinically manifests first by an abnormal joint tissue metabolism followed by anatomical changes such as cartilage degradation, bone remodelling, formation of osteophyte, joint inflammation and consequent loss of normal joint function.

OA symptoms often develop slowly, worsening over time, and are characterised by joint pain, swelling and stiffness leading to movement limitations, fatigue, loss of full range of motion and ultimately of independence resulting in reduced quality of life.

The main symptom of OA is pain, described as dull and aching, becoming more constant over time with episodes of short-lived but more intense pain.

The nature of these disorders is quite heterogeneous, ranging from those with sudden onset and transitory nature, such as strains, sprains and fractures, to those with chronic development associated with ongoing pain and disability.

The prevalence of many of these conditions increases sensibly with age and many are directly linked to lifestyle factors such as obesity and sedentarity.

Typically characterised by often persistent pain, weakness, stiffness and decreased range of motion, musculoskeletal conditions have an impact that goes well beyond symptomatology, reducing people's ability to work and participate in social roles, affecting their psychosocial status and worsening mental wellbeing and health-related quality of life.

According to a recent research compiled by Arthritis Ireland and The Work Foundation as part of a bigger pan-European study entitled "Fit For Work", it appears that musculoskeletal disorders account for 49% of all absence from work, with Ireland ranking just above average at 50%.

The evidence of this study also suggests that: • Over half of Irish workers experience back pain each year

• Over a quarter of non-fatal work injuries in Ireland are linked to back pain • 60% of Irish workers experience muscular pain in neck, shoulders and upper limbs • 915.000 people in Ireland suffer from arthritis • 25% of all visits to doctor's surgeries each year are linked to arthritis and other musculoskeletal conditions Pain is the common denominator and most prominent symptom of all musculoskeletal conditions and might affect muscles, bones, ligaments, tendons and nerves.

Can be localised in one area or perceived throughout the whole body in widespread conditions like fibromyalgia, ranging from mild to severe enough to interfere with the daily life.

Four are the main and most common musculoskeletal conditions: osteoarthritis, rheumatoid arthritis, osteoporosis and low back pain.

Osteoarthritis Osteoarthritis (OA) is a disorder affecting movable joints, most commonly hands, knees, hips and spine, characterized by focal areas of loss of articular cartilage within the joint, initiated by micro and macro injuries that activate

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Osteoarthritic pain has both a peripheral and central nature: originating from nociceptive, inflammatory pathways stimulated by bone lesions, structural bone changes, neo-vascularisation and new nerve generation in cartilage, it is centrally enhanced through the formation of dysfunctional synaptic connections and transmission.

Epidemiological studies have also linked the condition to a multi-morbidity pattern, with cardiovascular disease, diabetes mellitus, hypertension and obesity being the most common.

This correlation constrains the pharmacological approach towards treating OA symptoms with the currently available analgesics and anti-inflammatory drugs, as it makes sufferers more prone to experiencing side effects to the drugs normally used for their management. Furthermore, the pain induced by OA may limit significantly the interventions required for the management of the co-morbidities like meeting physical activity guidelines or addressing weight loss though exercise.

As a chronic condition with no cure, treatment for OA is ongoing.

Traditional analgesics have been used for several decades for the treatment of pain in OA, like non-steroidal anti-inflammatory drugs. Inhibiting the activity of cyclooxygenase (COX) enzymes 1 and 2, NSAIDs decrease the synthesis of prostaglandins, resulting in analgesia. Topical and

oral NSAIDs are equally effective in treating localized OA pain, but the use of topical preparations for the treatment of localized pain is preferred and limits the risk of side effects.

Paracetamol has also been used as first-line treatment of mild to moderate pain in OA. Its mechanism has both peripheral (COX 1 and 2 inhibition) and central (through activation of descending serotonergic pathways) analgesic effect, but it results less effective than NSAIDs in treating OA hip and knee pain.

Topical preparations of capsaicin, an active component of chilli peppers, are also used to alleviate local pain, mainly conjunction with other treatments.

Chronic, long-term use of opioids is currently strongly discouraged due to the very serious side effect profile and prescribed only in a selected number of patients in the lowest effective dose for the shortest duration.

Particular attention should be paid to joint modifying treatments: several drugs have shown ability to slow down or even reverse the joint damage caused by OA. This is the case of chondroitin and glucosamine, used in monotherapy or in combination, showing a statistical decrease in joint-space narrowing, increase in mobility and improve in functionality.

Intra-articular steroids also fall in this category: despite showing no long-term benefit, their use seems effective in limiting exacerbations of acute episodes of OA pain.

Rheumatoid Arthritis Rheumatoid Arthritis (RA) is a symmetric polyarticular inflammatory condition with synovial joint involvement. It is the most common form of polyarthritis and although being a systemic disease, it predominantly affects peripheral joints.

Being a progressive disease, in the absence of appropriate treatment, the persistent inflammation can lead to erosive joint damage and disability.

The onset may vary from patient to patient according to type, number and pattern of the joint involvement and so will the course of the disease based on genetic background, frequency of swollen joints and the severity of the inflammatory process.

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References: 1. Merry A, et al. AFT-MX-1, a prospective parallel group, double-blind comparison of the analgesic effect of a combination inhibiting drug, an anti-inflammatory drug and thiazide diuretic at the same time increases the risk of renal impairment. Blood of paracetamol and ibuprofen, paracetamol alone, or ibuprofen alone in patients with post-operative pain. Department of Anaesthesiology, dyscrasias have been rarely reported. Patients on long-term therapy with ibuprofen should have regular haematological monitoring.

University of Auckland, New Zealand 2008. *compared with the same daily dose of standard paracetamol or ibuprofen alone.

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 Easolief Duo 500 mg/150 mg film-coated tablets Each tablet contains paracetamol 500 mg and ibuprofen 150 mg. inhibitors) should be considered. Use with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

Presentation: A White, capsule shaped tablet with breakline on one side and plain on the other side. Indications: Short-term NSAIDs may lead to onset of new hypertension or worsening of pre-existing hypertension and patients taking antihypertensive symptomatic treatment of mild to moderate pain. Dosage: Adults/elderly: The usual dosage is one to two tablets taken every medicines with NSAIDs may have an impaired anti-hypertensive response. Fluid retention and oedema have been observed in six hours up to a maximum of six tablets in 24 hours. Children: Easolief Duo is contraindicated in children under 18 years. some patients taking NSAIDs. NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic Contraindications: Severe heart failure, known hypersensitivity to paracetamol, ibuprofen, other NSAIDs or to any of the epidermal necrolysis and Stevens-Johnson syndrome. Products containing ibuprofen should not be administered to patients with excipients, active alcoholism, asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs, history acetylsalicylic acid sensitive asthma and should be used with caution in patients with pre-existing asthma. Adverse ophthalmological of gastrointestinal bleeding or perforation related to previous NSAID therapy, active or history of recurrent peptic ulceration/ effects have been observed with NSAIDs. For products containing ibuprofen aseptic meningitis has been reported only rarely. NSAIDs haemorrhage, severe hepatic failure or severe renal failure, cerebrovascular or other active bleeding, blood-formation disturbances, may mask symptoms of infection and fever. Interactions: Warfarin, medicines to treat epilepsy, chloramphenicol, probenecid, during the third trimester of pregnancy. Warnings and precautions: This medicine is for short term use and is not recommended zidovudine, medicines used to treat tuberculosis such as isoniazid, acetylsalicylic acid, other NSAIDs, medicines to treat high blood for use beyond 3 days. Clinical studies suggest that use of ibuprofen, particularly at a high dose may be associated with a small pressure or other heart conditions, diuretics, lithium, methotrexate, corticosteroids. Refer to summary of product characteristics for increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic other interactions. Fertility, pregnancy and lactation: Easolief Duo is contraindicated during the third trimester of pregnancy. heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with ibuprofen after careful Driving and operation of machinery: Dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. consideration and high doses should be avoided. Careful consideration should be exercised before initiating long-term treatment If affected patients should not drive or operate machinery. Undesirable effects: Dizziness, headache, nervousness, tinnitus, of patients with risk factors for cardiovascular events. The use of paracetamol at higher than recommended doses can lead to oedema, fluid retention, abdominal pain, diarrhoea, dyspepsia, nausea, stomach discomfort, vomiting, flatulence, constipation, slight hepatotoxicity, hepatic failure and death. Patients with impaired liver function or a history of liver disease or who are on long term gastrointestinal blood loss, rash, pruritus, alanine aminotransferase increased, gamma-glutamyltransferase increased, abnormal liver ibuprofen or paracetamol therapy should have hepatic function monitored at regular intervals. Severe hepatic reactions, including function tests, blood creatinine increased and blood urea increased. Refer to Summary of Product Characteristics for other adverse jaundice and cases of fatal hepatitis, though rare, have been reported with ibuprofen. Paracetamol can be used in patients with effects. Pack size: 24 tablets. Marketing authorisation holder: Clonmel Healthcare Ltd., Clonmel, Co. Tipperary. Marketing chronic renal disease without dosage adjustment. There is minimal risk of paracetamol toxicity in patients with moderate to severe authorisation number: PA0126/294/1. Medicinal product not subject to medical prescription. For retail sale through pharmacy only. renal failure. Caution should be used when initiating treatment with ibuprofen in patients with dehydration. The use of an ACE A copy of the summary of product characteristics is available upon request. Date prepared: October 2019. 2019/ADV/EAS/120H.

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Pain

Clinical manifestations of RA might appear gradually as vague pain, without the typical joint stiffness and tenderness, making RA indistinguishable form other rheumatic disorders.

Therefore, identifying RA at the earliest onset is of paramount importance for the outcomes of the disease as early treatment can limit joint damage and erosion or even induce a remission state.

Patients with inflammatory arthritis may in fact pass several stages from the onset of the inflammatory disease to a specific form of rheumatic disease such as RA: • First phase, leading up to the onset of arthritis • Second phase, determines remission or development of disease • Third phase, is the development of a specific form of arthritis • Fourth phase, determines the outcome and severity of that arthritis Genetic background, environmental factors and treatment determine whether those four phases will develop in rapid succession or progress slowly. Furthermore,

despite 10% of early RA naturally experiences remission, there is evidence that early treatment prevents development of RA and in some patients exerts curative effect. On the other hand, inappropriate treatment of RA in patients who will not develop RA is harmful and should be avoided.

Unlike the wear-and-tear damage of osteoarthritis, RA induces the immune system to mistakenly attack your own body tissues, particularly the lining of the joints, causing painful swelling and inflammation which overtime will result in bone erosion and joint deformity.

Initially affecting the smaller joints, as the disease progresses it will often spread to larger joints like elbows, knees, hips and shoulders following a symmetrical pattern.

Pain in RA is the most significant complaint among patients, usually attributed to peripheral inflammation, is effectively treated with disease-modifying antirheumatic drugs (DMARDs).

Despite effective DMARDs therapy, many patients continue to suffer from mild to moderate pain suggesting non-inflammatory pain component, such as structural joint

damage or abnormal central pain regulation systems.

The mechanism leading to development of chronic widespread pain in RA patients is not clear yet, but it is believed that prolonged exposure to chronic pain during the course of the disease might induce alterations in central pain regulatory mechanism and central nervous system sensitization.

Treating pain in RA has historically meant reducing systemic inflammation via appropriate DMARD therapy. Recently, more attention has been directed towards addressing pain itself via three main treatment options: • First line therapy: non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol used in monotherapy.

• Second line therapy: NSAIDS + paracetamol or an alternative NSAID. • Third line threapy: weak opioids.

Adjuvant therapy might also be considered, for example the use of tricyclic antidepressants and neuromodulators in selected cases. On the other hand, there is evidence against use of systemic

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glucocorticoids for pain treatment in patient where active inflammation is absent as the adverse effects outreach the benefits.

Osteoporosis and Low Trauma Fractures Characterised by low bone mass, bone tissue deterioration and disruption of bone microarchitecture, osteoporosis (OP) is the most common chronic metabolic bone disease affecting an estimated 200 million people.

According to recent surveys from the International Osteoporosis Foundation, 1 in 3 women and 1 in 5 men over the age of 50 will experience osteoporotic fractures during the course of their life.

Osteoporosis is clinically silent until a fracture occurs, which can be highly debilitating and responsible for lasting disability, reduction of quality of life and also mortality.

Bone remodeling is a lifelong process where mature bone tissue is resorbed and new bone tissue is laid down in response to microdamage and functional demands.

When this process is unbalanced in favour of a higher rate of resorption, bone structure is undermined: trabecular bone plates are lost,

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Pain

consequently leaving a weakened bone structure with reduced mass.

OP itself is not a painful condition but it becomes painful subsequently to complications arising, such as vertebral compression fractures. These types of fractures cause severe and sudden back pain, worse when standing and less intense when lying down, troubles twisting or bending the body, loss of height and a curved spine.

Overtime, bone structure becomes more and more fragile, inducing the onset of multiple fractures causing continuous contraction of paravertebral muscles while maintaining posture, resulting in muscle fatigue and pain persisting even when the fracture heals.

In OP, chronic pain seems to have sensory characteristics of nociceptive and neuropathic pain meaning that the approach to treating it must include a pharmacological approach, combined with physiotherapy interventions and in some cases surgical treatment.

Treatment of pain with a peripherally acting drug, such as ibuprofen, appears to be more effective than a centrally acting medication, such as tramadol, but the pharmacological action of NSAIDs have a profound effects on bone metabolism, therefore should not be considered firs-line treatment for long periods of time. Opioids can be used when OP-associated pain is inadequately managed with first-line treatment agents.

Vitamin D is also often prescribed as contributes to stimulating osteoblast activity, therefore improving skeletal health and reducing overall risk of fractures, and consequent pain.

Antiresorptive drugs, such as bisphosphonates, are the most commonly used drugs for the treatment of OP and their therapeutic goal is to prevent fractures by improving bone strength, maintain a normal physical function and relieve symptoms of existent fractures and skeletal deformity.

Low Back Pain Usually defined as pain localized below the line of the twelfth rib and above the inferior gluteal folds, with or without involvement of the legs, low back pain is the most common musculoskeletal condition and constitutes a major health and socio-economic problem in western countries.

Classified as specific (with a pathological cause) or non-specific, back pain is usually defined as acute (if lasting less than six weeks), sub-acute (lasting more than six weeks and less than three months) and chronic (lasting more than three months).

Most episodes of low back pain tend to settle after a few weeks, but up to 44% of people affected will experience further acute episodes within one year.

Mainly affecting men, with the highest incidence seen in those aged between 25 and 64 years old, non-specific low back pain's

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occurrence is associated mainly with physical factors such as fitness, strength of back and abdominal muscles and excess body weight.

The impact low back pain has on the individuals affected is quite severe: very often the persistent pain experienced during the acute episode lacks full resolution, leaving a background of chronic pain.

Pain is often worsened by long walks, prolonged standing and sitting, with consequent mobility restrictions. Pain might also affect sleep and the fear of recurrence may affect leisure pursuits and activities.

https://www.who.int/news-room/ fact-sheets/detail/musculoskeletalconditions https://www.thegoodbody.com/ back-pain-statistics/ https://www.oarsi.org/sites/default/ files/docs/2016/oarsi_white_paper_ oa_serious_disease_121416_1.pdf https://www.mayoclinic.org/ diseases-conditions/osteoarthritis/ symptoms-causes/syc-20351925 https://link.springer.com/ article/10.1007/s11926-018-0794-5 https://onlinelibrary.wiley. com/doi/full/10.1111/j.14609592.2008.02764.x

Low back pain symptoms can originate from many anatomical sources such as nerve roots, muscles, bones, joints, intervertebral structures and organs within the abdominal cavity.

http://www.columbia.edu/ itc/hs/medical/pathophys/ immunology/2004/misc/articles/ RA_review.pdf

A plethora of treatments is now available but evidence on the most effective is lacking: NSAIDs and muscle relaxant therapy relieve pain more than placebo, along with spinal manipulation, while no evidence shows that other interventions (such as lumbar supports, traction, massage or acupuncture) are effective for treating acute episodes.

https://www.arthritis.org/diseases/ more-about/how-rheumatoidarthritis-affects-more-than-joints

Bibliography

https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC4926733/

https://www.scielosp.org/article/ bwho/2003.v81n9/646-656/ https://www.eurofound.europa.eu/ publications/article/2010/negativeimpact-of-musculoskeletaldisorders-on-irish-labour-market

https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC3766928/

https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC3552517/ https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC5335887/ https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC4824363/

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Child Nutrition

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Pharmacy Role in Nutrition in Children The children’s nutrition market is far from an easy nut to crack. A recent New Nutrition Business Survey found that the failure rate in this sub-section of the food and beverage market was higher than in any other.

Of 71 kids start up brands started since 2003, 47% have completely disappeared.

Profitability for survivors has proved very challenging.

their place in the market and are demanded by parents. Brand leaders are the familiar player like Aptamil, Cow & Gate, SMA and Hipp Organic.

One brand however has bucked these trends. Ella’s Kitchen is a range of organic baby and toddler food from the UK sold in several international markets and has driven category change within childrens’ nutrition offering resealable, squeezable pouches as an alternative to the traditional glass jar.

These have been covered in recent articles in the IPN.

This packaging innovation fits with several of the consumer lifestyle trends now demanded by purchasers. It helps busy parents by providing greater convenience and keeps the product fresher for longer, helping them to get more healthy fruit and veg goodness into their little ones.

This is further emphasized by 2019’s Mintel Children’s Healthy Eating Habits which found that only 18% of children are eating the recommended 5 portions of fruit and vegetables every day. Of course, the pouches from the Ella’s Kitchen range are also more sustainable, the brand being very keen to stress its green credentials and how it needs fewer lorries and less fuel for transportation than its competitors. Its effect on supermarket own brand labels is evident.

Follow on-formulas, although not specifically recommended by healthcare experts, still hold

Written by Rob Wood, MPSI, MRPharmS DHPH, Superintendent Pharmacist, Cara Pharmacy Group

The New Nutrition report makes further recommendations that Irish food and drink companies interested in developing kids products should take note of.

The age range targeted is a real determinant of success. The 1-6 year olds are the easiest to win over.

Primarily it’s parents who are the decision makers as to what children in this age bracket eat.

They want reassurance they’re giving their children the best start possible so health is a strong motivation for purchase.

‘No added sugar’ is a requirement.

Parents will accept the natural sugar in fruit and vegetables given their other nutritional components but reject anything else as ‘unhealthy’.

Finally, when it comes to the type of product to devote shelf space to, think ‘snackification’. This is partly driven by its ‘anywhere, anytime food’ positioning. It can be lunch at home or at school or it can be a ‘between meal’ filler before playgroup or extracurricular activity. Contrast this with ranges of child-friendly,

chilled ready meals. The Kiddylicious range of finger foods branded to promote real fruit constituents are extremely popular and have performed well over the last 12 months.

all the nutrients they need for the best start, no matter if breast or bottle fed. Vitspritz is a newer brand that delivers doses by spray orally and has quickly become popular.

Outside of actual food products, supportive products remain popular and are often driven by new parent information, back to school or examination cycles.

Vitamin D - BabyVit D3 and Well Baby Vit D drops are the strongest performers here. There is no new parent list that this product does not feature on. The health promotion message really is hitting home with parents that this is an essential part of a new baby regimen.

Multivitamins - Well Baby is the market leader followed by Haliborange as a trusted brands and are often sought by new parents to ensure that baby has

Energy - Haliborange and Pharmaton are most purchased in this category. Parents are looking to ensure that all bases

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Child Nutrition

are covered and in particular want reassurance that fussy eaters in particular are not missing out on any nutrients for energy.

as Eskimo have moved into the area and there is a large focus on taste as original products were considered less palatable.

Immunity - Sambucol is a handsdown winner. Trusted and enjoyed by many families for many years it is purchased as prevention and support for active cough/cold/flu symptoms.

Probiotics have surged in popularity in recent years and are often endorsed by pharmacist recommendations in cases of poor health or to support recovery after antibiotic therapy. Bio-Kult, Afflorex and Udo’s Choice are market leaders in this area.

Omega-3 - Vital at back to school and examination time. Equazen arrived to market with much fanfare and a link to a health study, however other brands, such

With respect to healthy lifestyle advice, pharmacy colleagues who are parents can empathise

that we’re all aware of the healthy eating advice that can be followed for children. However, the worry that goes along with making sure they eat something, even if it’s not the “right” thing is very stark for any parent and so it is important to offer this advice in a non-judgemental way. This is where continued relationship building with patients that is the cornerstone of pharmacy practice becomes invaluable. Knowing that you have advice to give and really understanding your customer so that you know when and how to deliver it is key on this topic.

It’s important to focus on the evidence base and align advice with national guidelines, so make sure you and your team are aware of them. Checking with parents how they think things are going can help lead a conversation e.g.: “How do you think your little one is doing in getting their 5 a day? It can be really hard, can’t it?”

“With all the advice that is around, it can be hard to choose the right foods to give a balanced diet - will we check what is recommended for your child and look at some appropriate supplements?”

“If you’d like to check what’s considered a healthy and normal weight for the age of your little one, we can help you find out.

We can even help take the measurements if you’d like.”

For specific scenarios like when vegetarian parents make a choice for their child to eat a vegetarian diet, the job of the pharmacy is to highlight potential deficiencies that may arise, but more importantly offer solutions to support parents. Signposting details for Nutritionists and Dieticians should be available to the team to refer for extra care if needed.

Pharmacy and pharmacists still remain one of the most accessible healthcare professionals and first ports of call for queries from patients regarding infant and toddler feeding or supplements.

Having a reliable range to recommend from is invaluable to ensure that your advice is acted on and even inspires the next visit to the pharmacy for any other queries at each life stage of children.

Surge in Childhood GP Visits The Irish Medical Organisation (IMO) has said that GPs around the country are reporting a “surge” in the number of children attending for assessment for possible Covid 19.

Dr Denis McCauley, Chairman of the GP Committee of the IMO said the increase in assessments for children was being experienced across the country. “Our GP members right across the country are reporting a very significant increase in request from parents for assessments of their children for possible Covid-19. We had anticipated a development like this following the long awaited reopening of the schools but we are nevertheless struck by the volume of enquiries being received by members.”

Dr McCauley said the IMO supported the reopening of schools and that Public Health doctors were working closely with schools across the country to manage any reported cases of Covid.

“It is absolutely right that the schools have reopened and that parents are seeking advice on possible Covid cases. The increase in demand for assessments is positive as it demonstrates that parents are monitoring their children’s health closely. It also

PHARMACYNEWSIRELAND.COM

allows the GP an opportunity to assess each presentation and to filter out non-essential testing but also to pick up important nonCovid presentations. By being proactive, they are doing their bit to prevent the spread of Covid within the schools and the wider community and are doing a great job but it is important that all of us in society support this by doing our bit handwashing, social distancing and reducing contacts.

We cannot forget the basics and if anyone has symptoms they

should immediately self-isolate and contact their GP.” Dr McCauley emphasised that parents with concerns about Covid 19 should focus on fever, sudden onset of cough or a child who is generally unwell with loss of taste or smell. Dr McCauley also encouraged parents to refer such cases to their GP as soon as symptoms develop as their GP is best placed to give a full assessment of each presentation.

30 30

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66

Educational

Osteoporosis and what Women need to know World Osteoporosis Day (WOD), on October 20 each year, marks a year-long campaign dedicated to raising global awareness of the prevention, diagnosis and treatment of osteoporosis.

Childhood, adolescence and early adulthood are the times when most bone mass is being made, but even if the client is postmenopausal we still have much in the way of advice to offer, including ensuring the diet has adequate calcium and vitamin D. Calcium is most easily obtained from dairy foods, but as an increasing number of Irish people are avoiding dairy products, advise about alternatives. Spinach, broccoli, baked beans, brazil nuts, tofu, tinned salmon or sardines, and apricots are all alternative sources of calcium. Low fat dairy products contain as much calcium as full fat products.

Vitamin D is obtained from sunlight, cod liver oil, oily fish, eggs, dairy products and margarine. If there is doubt about the amount of calcium and vitamin D that the patient is taking a supplement can be given.

There is a direct relationship between the lack of estrogen during perimenopause and menopause and the development of osteoporosis.

With World Menopause Day also being held on October 18th, community pharmacists need to be aware of the common presenting signs, symptoms and available treatments and advice, both to manage these conditions and to optimise health and wellbeing.

WOD aims to make osteoporosis and fracture prevention a global health priority by reaching out to health-care professionals, the media, policy makers, patients, and the public at large. The campaign will feature “THAT’S OSTEOPOROSIS” as a headline, highlighting emotionally impactful visuals and stories of real people living with osteoporosis in all regions of the world.

At present it is estimated that 300,000 people in Ireland have Osteoporosis. One in 4 men and 1 in 2 women over 50 will develop a fracture due to Osteoporosis in their lifetime. The disease can also affect children.

20% of people aged 60+ who break their hip will die within 6 to 12 months, due to the secondary complications of breaking a bone.

50% of people aged 60+ who break a hip will lose their independence. They will be unable to wash or dress themselves or walk across a room unaided. These statistics are why it is so important that people take responsibility for their bone health and check to see if they are at risk.

Only 15% of people in Ireland are actually diagnosed with bone loss, leaving 280,000 undiagnosed and facing losing their independence.

The WOD campaign will emphasize the direct link between osteoporosis (the silent, underlying disease) and broken bones, which have a serious, life-changing impact in terms of pain, disability and lost independence. It will also focus on osteoporosis as a ‘family affair’, with family caregivers often carrying the burden of care, and the disease affecting multiple generations of the family.

Signs that a person may have undiagnosed Osteoporosis.

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Usually the first sign of Osteoporosis is a fragility (low trauma) fracture e.g. a broken bone due to a trip and fall from a standing position or less.

Symptoms that a person may have undiagnosed Osteoporosis • Upper, middle or low back pain, especially if the pain is intermittent • Loss of height: It should not be considered normal to lose height as you age • Head protruding forward from the body, shoulders becoming rounded, the development of a hump on the back and / or a change in body shape (waist appears bigger or a pot belly develops).

Most people have no pain until a fracture occurs, but a very small percentage of people have had back or hip pain, prior to a fracture.

Maintaining Bone Strength Prevention is always better than cure. Much can be done to encourage the body to lay down healthy, strong bones.

A number of alternative agents for the treatment of established osteoporosis have emerged.

These include biphosphonates (improve absorption of calcium into bone); calcitonin; calcitriol; fluoride; anabolic steroids; and selective oestrogen receptor modulators (SERMs).

Teriparatide is a self-injecting device which can be administered at home with a recommended dose of 20 micrograms, to be administered once daily by subcutaneous injection in the thigh or abdomen. Each dose of 80 microlitres contains 20 micrograms of teriparatide and one pre-filled pen of 2.4ml contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml). Alongside treatment with teriparatide, supplemental calcium and vitamin D should also be taken by patients if dietary intake is inadequate.

Patients must be trained to use the proper injection technique and on the correct use of the pen. The maximum treatment duration should be no more than 24 months and treatment should not be repeated over a patient’s lifetime. Following cessation of teriparatide therapy, patients should be continued on other osteoporosis therapies.

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Educational

Teriparatide is indicated for the treatment of osteoporosis in postmenopausal women, men at increased risk of fracture and those in glucocorticoid-induced osteoporosis. It is generally considered a second line therapy for the treatment of osteoporosis however may be considered first line therapy in specific cases such as postmenopausal women at very high risk of fracture or patients with glucocorticoid-induced osteoporosis and multiple prior vertebral fractures.

What Women Need to Know There are multiple reasons why women are more likely to get osteoporosis than men, including: • Women tend to have smaller, thinner bones than men. o Estrogen decreases sharply when women reach menopause, which can cause bone loss. This is why the chance of developing osteoporosis increases as women reach menopause.

There is a direct relationship between the lack of estrogen during perimenopause and menopause and the development of osteoporosis. Early menopause (before age 45) and any prolonged periods in which hormone levels are low and menstrual periods are

absent or infrequent can cause loss of bone mass.

All post-menopausal women are at risk of osteoporosis and by the age of 80 over 25% of woman will have suffered one or more osteoporotic fracture. Risk factors for the condition include: family history; dietary problems; premature menopause; smoking; prolonged amenorrhoea; low trauma fracture; secondary to certain medication such as steroids; or certain conditions such as anorexia and malabsorption.

Menopause is defined as the point when a woman has her last ever period and signals the end of menstruation and fertility. It will only be in retrospect that they are aware of this occurrence, and they will need to have had no periods for over 1-2 years for menopause to have occurred.

For a lot of women most of the symptoms take place in the 4-8 years before menopause, during the phase called perimenopause.

It is a natural time of transition and an inevitable outcome for all women.

According to the Irish Department of Health and Children, around 260,000 women in Ireland are going through the menopause at any one time.

Signs and Symptoms The most commonly reported menopausal symptoms are: • Hot flushes: A hot flush is a sudden sensation of heat in the upper body, typically the face, neck or chest, which radiates upwards and downwards, but usually lasts only a few minutes. The skin may become flushed or blotchy and women may also experience sweating, tachycardia (a rapid heartbeat) or palpitations.

• Sleep disturbances: Disrupted sleep is most often due to night sweats (the night-time manifestation of a hot flush), but can also be due to mood problems or primary sleep disorders. Long-term sleep disturbances can lead to irritability and problems with short-term memory and concentration.

• Urinary and vaginal symptoms: Women undergoing menopause often complain of vaginal dryness, discomfort, itching and pain during sexual intercourse (dyspareunia). Vaginal symptoms affect around a third of women in the early postmenopausal period, rising to almost half during the later postmenopausal period. Recurrent lower urinary tract infections are also more common during menopause.

Other potential symptoms associated with menopause include loss of libido, headaches, depression, anxiety and tiredness.

Hormone replacement therapy (HRT) is the cornerstone of pharmacological treatment of menopause symptoms.

Most HRT preparations contain small doses of oestrogen or drugs with oestrogenic properties, which effectively alleviate vasomotor symptoms and reduce the risk of osteoporosis when taken in either the peri- or postmenopausal period. Oestrogen is typically combined with progestogen in women with an intact uterus in order to reduce the risk of endometrial cancer. Common side effects of HRT include breast tenderness or enlargement, nausea, headache and bleeding.

Tibolone is a synthetic hormone alternative to HRT, combining oestrogenic and progestogenic activity with weak androgenic activity, which is administered in a tablet formulation. Its side effects are similar to HRT and it is contraindicated in patients with a history of cardiovascular or cerebrovascular disease, uninvestigated vaginal bleeding and porphyria.

The choice of HRT for an individual woman should hinge on an overall balance of indication, risk and convenience.

A variety of vaginal lubricants and bioadhesive moisturisers are also available that can help ease symptoms of vaginal discomfort and dryness; many of these can be purchased over the counter.

KEY MESSAGES • Osteoporosis is the underlying cause of painful, debilitating and life-threatening broken bones – known as fragility fractures.

• Osteoporosis is a growing global problem: worldwide, fractures affect one in three women and one in five men over the age of 50.

• Osteoporosis affects families – family members often bear the burden of care • If a parent had osteoporosis or hip fracture, this may increase an individuals own risk of developing the disease.

PHARMACYNEWSIRELAND.COM

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70

Business CPD

Pharmacy Consultations in the ‘New Normal’ Pitfalls and Success Tips IPN’s Pharmacy Business Excellence Series is for community pharmacists committed to growing their professional and business knowledge and skills to overcome challenges and thrive as a community pharmacist.

IPN is proud to partner with 4Front Pharmacy to bring you the ‘IPN/4Front Pharmacy Business Excellence Series.’

Our goal for you and your team is that you develop the knowledge, skill and the courage to embrace your challenges and opportunities, take the necessary leaps of faith to reap the rewards as you commit to pharmacy business excellence.

Each month, Rachel Dungan shares best practice tips, insights from pharmacy leaders and showcases examples of pharmacy business excellence in action.

LEARNING OUTCOMES The aim of this article is to provide useful communication tips and tools to use during COVID-19 (and beyond).

At the end of this article you will be able to:

• Identify five key pitfalls to avoid • Apply a 5-STEP framework to mitigate the risks associated with these pitfalls, and optimise outcomes • Record your learning as CPD in your ePortfolio 60 SECOND SUMMARY: COVID19 has required both our patients and our teams to radically change how we communicate and fulfil our roles. We have seen a dramatic shift from in person consultations towards remote consultations. Many patients are no longer attending their GP or collecting their prescription in person. In addition, for those who attend the pharmacy in person, communication from behind masks changes the dynamic.

Prior to 2020, few of us had experience of communicating while wearing masks, or conducting video consultations.

In addition, the volume of phone consultations has escalated, and there has been a significant increase in dispensing where the ONLY contact with the patient is remote.

With this trend likely to continue, pharmacists and their teams need to adapt and develop skills and strategies to ensure that remote consultations and masked inperson consultations are effective and person-centred. How can we adapt our communication to better meet patient needs and safeguard their health and wellbeing in the current circumstances?

PITFALL 1: MAKING ASSUMPTIONS Gathering information is a core consultation skill. Given the radical changes to our way of life and methods of communication since March 2020, it is vital that we avoid making assumptions by explicitly seeking to understand the patient and their needs. This is important because masks and remote consultations reduce our ability to read body language, facial expressions and visual identity cues. This risk is further increased if either you or the patient don’t speak English as a first language, or if either of you have hearing difficulties.

BEST PRACTICE TIPS: SEEK TO UNDERSTAND 1. Confirm the identity of the person you are talking to and their relationship with the patient (in the case of a patient representative).

2. Manage expectations by explaining the consultation process and its purpose at the beginning of the consultation.

3. Seek to understand the patient’s agenda, by asking an

PHARMACYNEWSIRELAND.COM

open question e.g. What would you like to discuss today?

Listen attentively to the patient’s response, without interrupting.

PITFALL 2: GIVING TOO MUCH INFORMATION Giving too much information before checking if the message intended is indeed the message received can risk miscommunication, especially in the absence of facial expression cues.

BEST PRACTICE TIPS: THEN BE UNDERSTOOD 1. Assess the patient’s starting point, by asking them what they already know. E.g. What do you already know about this?

This saves time and evaluates the accuracy of the patient’s current understanding.

2. Provide information in small chunks. Then, 3. Check for feedback e.g. ‘As I share that, what’s coming up for you?’ Or ‘What questions do you have about what I’ve just shared?’

This enables you to check if the message intended is in fact received and allows you to correct any misconceptions.

PITFALL 3: IGNORE EMOTIONS The COVID-19 pandemic is fraught with stress and difficult emotions such as fear, loneliness, anxiety and worry. Given the context, it is more challenging (yet even more important) to recognise and acknowledge emotions and convey CARE in our consultations. In the

absence of visual cues, we rely on other senses such as hearing to convey care.

‘People don’t care how much you know until they know how much you care.’

Theodore Roosevelt BEST PRACTICE TIPS: DEMONSTRATE EMPATHY 1. Reduce distractions.

Don’t multi-task. Listening requires your full attention. People can sense when you are only half listening, even on the phone.

2. Verbally convey respect.

Introduce yourself and your role.

Use the person’s name. Seek permission to consult with the patient. E.g. ‘Is now a good time to speak?’

3. Actively listen. One effective skill is to reflect the emotion you are hearing back to the person using the phrase ‘sounds like.’

E.g. ‘Sounds like you are worried’.

PITFALL 4: TECHNOLOGY PROBLEMS Technology problems can be divided into technology failures and user challenges. It is important to mitigate the risk of these problems arising, as they make communication more difficult and create a negative experience for both parties.

BEST PRACTICE TIPS: PROBLEM SOLVE Mitigating Technology Risks 1. Check the connection in advance, for both you and the

71 patient e.g. mobile phone signal, mobile internet, broadband etc.

2. Agree a back up plan in advance e.g. a mobile/landline telephone number.

3. Check equipment in advance e.g. camera, headphones.

Technology User Tips 1. Check the environment. Are both you and the patient in a confidential space? Is there background noise?

2. Check the equipment. If using a camera, check the quality and angle of the camera so that you appear to be looking directly at the patient.

3. Sound and lighting. Your posture, breathing and facial expressions affect the tone of your voice. Before phone and video consultations, take a deep breath, smile, and sit or stand with a straight back and shoulders back. For video consultations, sit with the light towards your face to ensure the patient can see you.

PITFALL 5: NO CLEAR FOLLOW UP To prevent misunderstanding, before closing the consultation, remember to explicitly confirm that both you and the patient have a shared understanding of the next steps.

BEST PRACTICE TIPS: SAFETY NET 1. Check shared understanding. Ask the patient to tell you the most important things they will take from the consultation.

2. Forward plan. Explain what will happen next and agree the next steps for you and the patient.

Document the call and follow up plan.

5: No Clear Follow Up Five best practice STEPS to minimise the negative consequences of succumbing to these pitfalls and optimise outcomes are: 1. Seek to Understand 2. Then Be Understood 3. Empathise 4. Problem Solve WITH the other Person 5. Safety Net AUTHOR: Rachel Dungan MPSI, ACC. Known as ‘The Pharmacist Coach,’ Rachel Dungan MPSI co-founded 4FrontPharmacy,

a leading edge, online membership platform, designed by pharmacists, for pharmacists and their teams, so that they can continually improve the quality of pharmacy– patient interactions.

awarded ‘Best Educational Project in Pharmacy and General Practice’ at the Irish Healthcare Awards.

Rachel is a pharmacist, an ICF credentialed professional coach, a certified Professional Medical Coach (PMC), a Lifestyle Medicine Practitioner (European Lifestyle Medicine Organisation) and an award-winning executive and leadership coach. Experienced in developing professional online learning communities, she has held positions as Programme Coordinator for the Global Health and Wellness Coaching Community of Practice and facilitator at the World Business and Executive Coaching Summit.

4FrontPharmacy Online has been

3. Safety net. Tell the patient what you would expect to happen if all goes well and what to do if symptoms worsen.

In summary, five key pharmacy consultation pitfalls to avoid are: 1: Making Assumptions 2: Giving Too Much Information 3: Ignoring Emotions 4: Technology Problems

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72

Business CPD Pharmacy Consultations during Covid-19

S

Self-Appraisal WHAT I intend to learn and why COVID19 has required both our patients and our teams to radically change how we communicate and fulfil our roles. We have seen a dramatic shift from in person consultations towards remote consultations. Many patients are no longer attending their GP or collecting their prescription in person. In addition, for those who attend the pharmacy in person, communication from behind masks changes the dynamic.

Since ‘Patient Consultation Skills’ and ‘Patient Counselling Skills’ are two of the PSI Core Competencies, I intend to focus my CPD on best practice in remote consultations.

The specific behaviours I have identified to focus on are • 4.1.1. Consults with the patient/carer to obtain relevant patient medication and disease history, • 4.1.2 Uses appropriate communication techniques to gather relevant patient information, • 4.1.3 Structures consultations against a protocol and uses the consultation area appropriately, • 4.1.11 Effectively supervises non-pharmacist staff in relation to non-prescription medicines, • 4.2.2 Maximises opportunities for counselling and providing information and advice to patients • 4.2.5 Provides the patient with sufficient information to assure the safe and proper use of the medicine • 4.2.6 Assesses patients' understanding and knowledge of the medicines and provides appropriate information and education

P

Personal Plan HOW I intend to learn it I plan to • Observe OTC pharmacy phone and face to face consultations using Section 2 of the Pharmacy Assessment System to assess how consultations have been affected by COVID19 regulations.

• Enrol myself and my staff on 4FrontPharmacy’s Online Training, to ensure that the information, advice and education we provide patients is consistent with public health advice.

• Review my Pharmacy Work Practices and Consultation SOPs to include remote consultations.

A

Action What I actually did • I completed my Pharmacy Assessment System Review of OTC pharmacy consultations, including phone and video consultations.

• Our entire team enrolled on 4FrontPharmacy’s Online training. We are focusing first on the STEPS Consultation Framework as it applies to Vaccination Conversations.

• I reviewed our Pharmacy Work Practices related to phone and video consultations and we updated our patient consultation SOP.

D

Document What I have learned specifically • Over 50% of our consultations are now conducted on the phone. I realised that it is very difficult to supervise remote consultations, as I can only hear half of the conversation. I noticed that both customers and staff seem more rushed and less present during the consultations resulting in poorer quality consultations.

• After we had completed 4FrontPharmacy’s STEPS training, I asked each staff member what most resonated for them. Staff commented that they realised they had deprioritised consultations to such an extent that they had almost come to view phone consultations as a nuisance (rather than a core part of the pharmacy service).

• By completing the 4FrontPharmacy STEPS Training and discussing COVID implications on pharmacy consultations with my team, we revised and updated our Pharmacy Consultation SOP to highlight the priority we place on high quality consultations, especially when the patient is not personally present in the pharmacy.

E

Evaluate ONE example of how I put my learning into practice • All our staff received specific training in remote consultation skills, to help them apply the same standard to phone consultations as in person consultations.

• I have re-organised the work flow in the pharmacy so that my first priority is patient consultations, at the pharmacy counter and on the phone. I see this as a critical shift in focus, since the pharmacy is the last point of contact our patients have with the system. In many cases, this consultation is remote, and therefore not a task I can safely delegate.

• We have hired 4FrontPharmacy to conduct Pharmacy Assessment Review to assess the degree to which the STEPS Consultation Framework is transferred into both remote and in person consultations. Our goal is to use these observations to demonstrate improve adherence to the PSI Practice Guidance on the Sale and Supply of Non-Prescription Medicines and Public Health Guidelines on COVID 19.

CCF Domains (and Competencies) The Pharmacist selected Competencies under the following domains for this CPD 1. Professional Practice (Engages in appropriate CPD), 4. Safe and Rational Use of Medicines.

Contributed by Rachel Dungan MPSI of 4Front Pharmacy. To find out more about how 4Front Pharmacy’s ONLINE training can help you drive your sales, improve patient safety and engage with your patients and team, (even in a pandemic), email Rachel.Dungan@4FrontPharmacy.ie and use the subject line ‘IPN 2020.’

PHARMACYNEWSIRELAND.COM

EMERGENCY CONTRACEPTIVE NOW AVAILABLE FROM YOUR LOCAL PHARMACY NOTIFICATION OF AVAILABILITY OF RAMONNA 1500 MICROGRAM TABLET (levonorgestrel) (FORMERLY KNOWN AS PREVENELLE) FROM GEDEON RICHTER Plc. Gedeon Richter the Marketing Authorisation holder of Ramonna 1500 microgram Levonorgestrel emergency contraception (formerly known as Prevenelle), wishes to announce that the product with the new trade name Ramonna is available again on the Irish market.

The product shall be distributed through United Drug Distributors.

The product is exactly the same as its predecessor Prevenelle only the name on the box has changed. Ramonna’s reimbursed price remains at €6.81.

The PA number of the product (PA 1330/021/001) and GMS code will remain the same. EAN Code is now 5997001327449.

If any pharmacies require a patient checklist, please contact us by email or phone on: sales.uk@gedeonrichter.eu and +44 (0) 7957 705415.

Prescribing Information Ramonna Presentation: Ramonna (levonorgestrel)1500 microgram tablets.

Indications: Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.

Dosage and administration: One tablet should be taken orally, 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. Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception (EC) are recommended to use a non-hormonal EC, i.e. Cu-IUD or take a double dose of levonorgestrel (i.e. 2 tablets taken together) for those women unable or unwilling to use Cu-IUD. Taking a double dose of levonorgestrel (i.e. 3000 mcg within 72 hours after the unprotected intercourse) is an option for women who are unable or unwilling to use a Cu-IUD, although this specific combination (a double dose of levonorgestrel during concomitant use of an enzyme inducer) has not been studied. Ramonna can be used at any time during the menstrual cycle unless menstrual bleeding is overdue. After using EC, it is recommended to use a local barrier method until the next menstrual period starts. The use of levonorgestrel does not contraindicate the continuation of regular hormonal contraception.

Contraindications: Hypersensitivity to levonorgestrel or to any of the excipients.

Warnings and precautions: EC is an occasional method. It should in no instance replace a regular contraceptive method. Women who present for repeated courses of EC should be advised to consider and initiate long-term methods of contraception. Repeated administration within a menstrual cycle is not advisable because of the possibility of disturbance of the cycle.

EC does 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 the expected date of menstrual periods or pregnancy is suspected for any other reason, pregnancy should be excluded. If pregnancy occurs after treatment with levonorgestrel, the possibility of an ectopic pregnancy should be considered. The absolute risk of ectopic pregnancy is likely to be low, as levonorgestrel prevents ovulation and fertilisation. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding. Therefore, levonorgestrel is not recommended for patients who are at risk of ectopic pregnancy (previous history of salpingitis or of ectopic pregnancy). Levonorgestrel is not recommended in patients with severe hepatic dysfunction. Severe malabsorption syndromes, such as Crohn's disease, might impair the efficacy of levonorgestrel. After levonorgestrel intake, menstrual periods are usually normal and occur at the expected date. They can sometimes occur earlier or later than expected by a few days. If no withdrawal bleed occurs in the next pill-free period following the use of levonorgestrel after regular hormonal contraception, pregnancy should be ruled out. Limited and inconclusive data suggest that there may be reduced efficacy of Ramonna with increasing body weight or body mass index (BMI). In all women, EC should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI. EC does not replace the necessary precautions against sexually transmitted diseases. Contains lactose monohydrate.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Interactions: levonorgestrel metabolism is enhanced by concomitant use of liver enzyme inducers, mainly CYP3A4 enzyme inducers. Concomitant administration of efavirenz has been found to reduce plasma levels of levonorgestrel (AUC) by around 50%. Drugs suspected of having similar capacity to reduce plasma levels of levonorgestrel include barbiturates (including primidone), phenytoin, carbamazepine, herbal medicines containing Hypericum perforatum (St. John's Wort), rifampicin, ritonavir, rifabutin, and griseofulvin. Levonorgestrel may increase the risk of ciclosporin toxicity due to possible inhibition of ciclosporin metabolism.

Fertility, Pregnancy and Lactation: Levonorgestrel should not be given to pregnant women. It will not interrupt a pregnancy. In the case of continued pregnancy, limited epidemiological data indicate no adverse effects on the foetus but there are no clinical data on the potential consequences if doses greater than 1.5 mg of levonorgestrel are taken. Levonorgestrel is secreted into breast milk. Potential exposure of an infant to levonorgestrel can be reduced if the breast-feeding woman takes the tablet immediately after feeding and avoids nursing at least 8 hours following levonorgestrel administration.

Levonorgestrel increases the possibility of cycle disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however, there are no fertility data in the long term. After treatment with Ramonna a rapid return to fertility is expected and therefore, regular contraception should be continued or initiated as soon as possible after EC use.

Undesirable effects: Very Common: headache, nausea, abdominal pain lower, bleeding not related to menses, fatigue. Common: dizziness, diarrhoea, vomiting, delay of menses more than 7 days, menstruation irregular, breast tenderness. Very rare: face oedema. Please consult SmPC in relation to other adverse events which can be found at https://www.medicines.ie/. Additional information is available upon request.

Legal category: Supply through pharmacy only.

Pack size and price: One tablet €6.81.

Marketing Authorization Number: PA1330/021/001.

Date of Authorisation: 03 Feb 2006.

Marketing Authorization Holder: Gedeon Richter Plc. Gyömrői út 19-21, H-1103 Budapest Hungary. Further information available from: Gedeon Richter UK Ltd, 127 Shirland Road, London W9 2EP. Tel: +44 (0) 207 604 8806.

Email: medinfo.uk@gedeonrichter.eu Date of Preparation: 16 June 2020.

Adverse events should be reported to the HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.

Adverse events should also be reported to Women’s Health Division of Gedeon Richter (UK) Ltd on +44 (0) 207 604 8806 or drugsafety.uk@gedeonrichter.eu

IE-RAM-2000007 September 2020

74

Finance: Measurements

Improving business performance through measurement - Part One There is an old business performance adage that says “what gets measured gets done” but before we can address measurement and performance appraisal first we must ask, “what do we measure and how do we measure it?”

Stuart Fitzgerald, Fitzgerald Power

When Operation Transformation participants stand on the scales at the end of the week the measurement they read is a lag KPI. It is measuring something that currently exists. The scales give a certain reading and that reading cannot be immediately changed.

However if a logical process is followed it is possible to achieve positive change. The strategic goal is clearly weight loss. The targets might be to exercise four times per week and to eat three nutritious, balanced meals per day. The actions are to join a gym, design a manageable exercise program and engage with a nutritionist to develop a diet plan. The lead KPI’s are calories burned and calories consumed. These lead KPI’s allow participants measure the impact of their actions. At the end of the following week when participants stand on the scales they will hope to have moved the dial on the lag KPI and to have created positive change.

To really understand measurement we have to understand our ultimate goals because the purpose of effective measurement is simply to link these goals to outcomes. If we measure the wrong things we may not get the correct outcomes.

For example if the goal is to be more profitable measuring sales and nothing else misaligns goals, measurement and outcomes where turnover increases do not necessarily create greater profits.

There are two types of performance measures - lead and lag indicators. Traditional KPI’s are lag indicators. They are a measure of something that has already occurred and accountants love them. We love them because they are easy to calculate and because they provide definitive answers to specific questions such as how have gross profit margins performed over the last 12 months or what the year on year value change in turnover is. Using lag KPI’s in isolation, however, does nothing to improve business performance, it just provides the final measure of success or failure.

Lead KPI’s on the other hand are more difficult to determine and

calculate but are predictive in nature and allow business people assess the impact of their actions during a period of activity.

Creating positive change in a business context is extremely important given the level of disruption in the Irish community pharmacy market since 2009.

These disruptions include:

When lead and lag KPI’s are combined and used correctly as part of a five step performance appraisal process they can help deliver better results. This process is:

1. Changes to payment terms introduced under the FEMPI legislation and Reference Pricing.

1. Set clear strategic goals.

2. Set targets. Completing these targets should result in strategic goals being achieved.

3. Determine the actions that will lead to targets being achieved.

4. Use lead KPI’s to measure the impact of actions.

5. Use lag KPI’s to assess ultimate success or failure.

Understanding this relationship and aligning core objectives with actions and measurement leads to positive change. At first glance this may appear to be an abstract and theoretical concept but in practice the process is very straightforward.

Operation Transformation is the perfect example.

PHARMACYNEWSIRELAND.COM

2. Changing economic conditions and consumer sentiment.

3. Price competition and the emergence of online channels for cosmetics and over the counter medicines.

Of these factors the impact of FEMPI and Reference Pricing is the easiest to quantify. The State extracted approximately ¤4.4bn from the community pharmacy sector between 2009 and 2019.

When viewed on a micro level the effect of these cuts has been the steady erosion of pharmacy revenue bases with the average community pharmacy suffering annual turnover reductions of approximately ¤331,000 as a result of FEMPI and Reference Pricing.

While our recent survey of the sector, conducted on behalf of

the IPU, noted average turnover improvements across the market in 2019 it appears that procurement margin gains have plateaued while controlling wages and rent remain key challenges.

When these legacy trading pressures are combined with current sectoral headwinds such as further Reference Pricing adjustments, challenging economic conditions and the emergence of new pharmacy business models it becomes clear that pharmacy owners will need to continue to develop and redefine their businesses if they hope to thrive in the future.

In recent years we have seen evidence of this development as pharmacists increased the range of services available in their shops and expanded their retail offerings.

Retail revenue streams, to include OTC medicine sales, accounted for 29% of pharmacy income on average in 2019 while the volume of pharmacy administered clinical services such as the flu vaccination continue to increase year on year.

While these developments are positive a logical system of measurement is required to accurately assess their impact and their contribution towards strategic goals.

What then should we measure?

There are dozens of KPI resources available online which are interesting and thorough but if you are using a large number of KPI’s to plan and manage your pharmacy you may be spending too much time measuring and too little time actually doing.

Often less is more. In the second part of this article, which will be published next month, we will discuss three essential pharmacy lag KPI’s and the targets, actions and lead indicators that can be used to influence them. We will also discuss developing systems for performance appraisal and the role this plays in delivering better business outcomes.

If you would like to discuss the matters raised in this article, please contact Stuart Fitzgerald of Fitzgerald Power at 051-870152 or sfitzgerald@fitzgeraldpower.ie.

top Calling for Nominations

IPN are now looking for your nominations for the Dynamic 100  The Covid-19 pandemic brought pharmacy professionals even further to the fore of healthcare provision. Do you know someone who went above and beyond during this time of huge challenge?  Who has inspired you this year?  Who deserves recognition for a special project they have executed this year?  Who has shown an ability to get things done during a period of change?  Who has developed something new and innovative within their organisation?

Please email your nomination(s) to kelly-jo@ipn.ie or editorial@ipnirishpharmacynews.ie before 12/10/20

76

Finance: Pensions

Pharmacists – Are you Pension Ready?

I could not begin to write any article directed to the pharmacy community without paying tribute to the incredible work done by the profession over the last 6 months. I’ve personally seen the efforts and impact borne by staff across the country and on behalf of us all thank you.

Colm Moore CFP™ is Certified Financial Planner with Moore Wealth Management. They have been advising pharmacists for over 20 years. They can be contacted on 086-8603953. For more see www.mwm.ie

What to look out for ?

One of the consequences of the last 6 months has been the extreme volatility seen in stock markets which have a direct impact on your pension portfolios and this has forced individuals to re-examine their pensions and ask have they the best pension vehicle for their needs.

It is always worth articulating that the single best way to save for your retirement is a well advised pension. With tax relief on contributions, tax free growth in the pension and a tax free lump sum up to ¤200,000 at retirement there is no comparison to saving personally. By investing personal or after tax money you lose 1% on entry to a fund in stamp duty, incur annual fees between 1 and 3% and taxation on gains at 41%.

Bearing all that in mind pensions are an incredible vehicle for providing you with the retirement you want.

Pensions are by no means the only way to retire and in conjunction with other tax efficient options and a solid financial plan backed up by cashflow modelling you will achieve the optimum retirement outcome.

Who should you seek advice from?

The market is increasingly turning more to the professionalism and higher standard of advice you receive from Certified Financial Planners™. The CFP™ standard is the highest level

of accreditation worldwide for financial advisers and for you and with the complexities of business ownership, profit extraction, retirement drawdown and inheritance tax planning there is no doubt this is the level where you need to source your advice. Less than 5% of the adviser market are operating at this level. If you have a CFP™ running full cashflow modelling you can rest assured you’re in good hands. With a Certified Financial Planning firm you will have full transparency on all fees and charges as these are all declared at the outset.

1) Cost is imperative. You would not pay more than the market rate for stock for your business yet every week we encounter pharmacists paying up to 300% more than is necessary for pensions which have a massive impact on value over time. To put this in context over the lifetime of a pension contract making a regular monthly premium contribution of ¤1,000 means contract A with a 1% charge will have 29% more in their fund than contract B with a 2% annual fee (¤1,137,494 v ¤1,463,103). If you don’t know your annual fee, find out.

2) Full allocation of your funds. I’m still surprised to see modern contracts that in an outdated and penal concept take up to 5% of the premium contribution made. Using the same criteria as above this results in a difference of ¤73,262 over the life of the pension. If you don’t know your allocation rate, find out.

3) Access to diversified asset classes and the best in class fund managers. Why settle for second best. If you don’t know the best fund managers, find out.

What are pensions investing in The latest figures from Mercer as at Aug 31st 2020 showed that Irish pension funds have decreased their equity holdings by almost a third in the last 3 years diversifying into fixed income and real assets(property and infrastructure) as new sources of returns. This is an area that has attracted a lot more attention in recent years as analysts, advisors and fund managers become more weary of the fundamentals underlying the valuation of equites.

This is evidenced by the extreme growth in concentrated sectors of the market for companies who cannot even issue guidance as to performance over the coming 6 months. There is no doubt there is a part in all portfolios for fixed income and real assets.

Environmental, Social and Governance-linked (ESG) investment Without doubt the second most spoken about topic in pension and investment circles after Covid this year is ESG investing. So what exactly is ESG investing and is it here to stay.

Impact of Charges €1,600,000 €1,400,000 €1,200,000 €1,000,000 €800,000 €600,000 €400,000 €200,000 €0

1 2 3 4 5 6 7 8 9 10111213141516171819202122232425262728293031323334353637383940 Portfolio A 1%

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PHARMACYNEWSIRELAND.COM

77 ESG is a set of standards seeking to reduce negligent corporate behaviour that may lead to environmental degradation, armament sales, human rights violations, racial or sexual discrimination, harmful substances production, worker exploitation and corruption, though this list is by no means exhaustive and remains disputed.

This is not a passing fad. European legislation (MifID II) is coming into force in 2021 that will alter how advisers interact with clients and make ESG investing part of advice process. The UK Financial Conduct Authority have said they will implement this next year.

When implemented in Ireland this will mean that as advisers we will need to determine a client’s ESG preferences and factor them into our processes when recommending investment products and explaining how these objectives are met.

A recent example of ESG in action from Aviva investors was when they took a position of being underweight Brazilian Government bonds due to an increase of 34% in deforestation of the amazon in the first 5 months of 2020. They had a meeting with the Brazilian vice president and informed the government that they would not be purchasing Brazilian government bonds due the fact that these actions have lowered its ESG score to a level where it is now excluded from their emerging market bond fund. This is direct and decisive action that has impact that Brazil now needs to consider as it becomes more difficult for them to raise funds in bond market.

By taking a position on ESG investors are naturally then drawn to businesses that operate properly and are less likely to encounter issues that can impact long term share price and investor return due to strong governance and oversight. Think of the Tesco accounting and Volkswagen emissions scandals. ESG themed investing can mitigate certain risks and another method of reducing risk in your pension is euro cost averaging

2. Invest the lump sum in smaller regular amounts (euro cost averaging) In this example we use a sample fund which starts the period with a price of ¤10 and ends the period with a price of ¤10 but with some significant volatility in-between. What this example illustrates is that the approach of drip feeding the investment in actually results in a lower average cost price. Of-course if the fund in this example had of made very strong gains from day 1 the approach of investing the full lump sum in one go at the start would have fared better. However, in uncertain market conditions this is a powerful approach to help avoid the gut-wrenching feeling any immediate and/or significant loss would induce. It also stops investors trying to second guess the best time to invest.

Euro cost averaging in practice In the below example we look at an investment into global equities (using the MSCI World) in the midst of the global financial crisis and we track the two approaches: Option A: ¤120,000 invested using euro cost averaging using 12 instalments of ¤10,000 each month Option B: ¤120,000 invested in one lump sum at the beginning of 2008 As the chart illustrates, option A had the much better outcome.

Essentially, investing regularly in a volatile and falling market results in buying more shares at a cheaper price than the lump sum investor. And by the end of 2010, when markets had recovered, the investment value of option A was approximately ¤22,000 higher than

option B and had already returned to positive territory despite the dramatic fall in markets. Option B’s investment value, on the other hand, was still below the initial investment amount.

In addition to better performance, drip feeding the investment (in this example) also reduced the investors maximum drawdown by ¤13,000 – i.e. option A’s value fell by ¤45,000 at any point in the journey (leaving the investment worth ¤75,000), while option B had fallen by ¤58,000 (leaving the investment valued at ¤62,000 at one point). By remaining invested both investments recovered but the journey was certainly less painful for Option A.

Advantages of Euro Cost Averaging Though often ignored euro cost averaging is important to pension investors. This approach of investing over the long term into the highs and lows of the market is compared and is illustrated by looking at two different methods of investing ¤10,000: 1. Invest the full lump sum in one go

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Banks and other lenders. Our clients range from SME’s to large international cl led approach, strong technical skills, and excellent relationships with lenders. S DebtBradshaw below.

78 Finance: please contact Jason

NavigatingUS: Debt CONTACT

PA BRENSON LAWLOR CORPORATE FINANCE & RECOVERY Covid-19 will have a major financial impact for many businesses. It is crucial that leveraged businesses assess their debt profile and understand the implications of reduced profits on their debt obligations and navigate towards an appropriate debt management strategy.

Jason Bradshaw FCA To change Corporate Finance & the Recovery capital Partner structure To grow T: 086-820-1442

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Jason Bradshaw, FCA is Corporate Finance and Recovery Partner with JPA Brenson Lawlor

the business E: Jason@brensonlawlor.ie

To acquire assets

Why is Debt Financing Bernard Berney FCCAused?

d by a business entially What is taking Debt Financing?

Debt financingand is the use of monies business To borrowed by a business from external sources. Debt financing mitigate Recovery Manager erestis essentially and taking themonies from Corporate someone outside of the business cashflow ng is and sought for promising to repay it, along with interest and the associated seasonality & senior conditions. Debt financing rms terms e.g. is sought for various reasons and To come in various forms e.g. marycan source of finance, senior debt, mezzanine refinance bonds etc. The primary source T: 01 668 9760 debt for many businesses in are ofIreland amounts existing are amounts borrowed from banks or alternative lenders. s. debt E: Bernard@brensonlawlor.ie

To initiate share buyouts

The Debt Financing Process

Securing debt financing may initially seem daunting to many businesses which are not accustomed to the processes involved or the various terminologies being used, however the right advisor will be able to help you clearly convey your goal, negotiate favourable terms, and fulfil the necessary completion points.

The second step involves sending the business plan to preferred lenders and allowing them an opportunity to review and request information on the proposal.

Bruce Waldron CING PROCESS

The third step and fourth steps, where your advisor can add real value, is the negotiation of the Heads of Terms (‘HOTs’) stage and Loan Offer Letter. HOTs will be provided by preferred lenders, this document provides an indication of the main terms and conditions (‘T&Cs’) attached to the loan e.g. repayment term, interest rate margin, arrangement fee’s, personal guarantee’s, conditions

precedents (‘CPs’) and financial covenants. The debt advisor to the business should be familiar with all aspects of the HOTs and can explain the T&C’s in lay-man terms to clients. The debt advisor will also assist in negotiations with the lenders on some aspects of the HOTs and Loan Offer Letter, which the client may view as unfavourable. It is important that the Loan Offer letter is reviewed to make sure there are no surprises from the HOTs.

step, which is completing the CPs. CPs are effectively pre-requisites by the lender which need to be fulfilled e.g. providing recent accounts or proving adherence to industry regulations.

most satisfying, is for the business Corporate Finance Senior Executive to drawdown the funds and to The last step, and no doubt the

HOTs and Loan Offer Letter, which then get to work on executing their strategy. the client may view as Impact of Covid-19 on Debt unfavourable. It Obligations is important that Once the HOTs have been agreed As mentioned in our previous a Loan Offer letter is signed, capacity to service the proposed the Loan Offer letter is reviewed to T: 01 668 9760 and the lender will focus on the fifth debt obligations.

Cashflow Management Article, make sure there are no surprises The third step and fourth steps, E: add Bruce@brensonlawlor.ie from the HOTs. where your advisor can real PHARMACYNEWSIRELAND.COM

The first step in the debt financing lenders and allowing them an process is to prepare a business plan, along with integrated opportunity towhich review and request financial projections, provide the potential lender with a clearly defined goal, an on insightthe into theproposal. information business and illustrative financial

drawdown and to then aspects of the HOTs and can explainwill struggle capacity to service the proposed businesses to service the funds fail to meet these covenants. businesses by effectively wiping get to work on executing the T&C’s in lay-man terms to debt obligations. their current debt, there are other For example, atheir business may have out the top-line i.e. Revenue (and which many The debt advisorconsiderations will also to debtstrategy. an agreed debt to EBITDA ratio of therefore the clients. bottom-line also).

6x, this means that the max level of assist in negotiations often with overlook. the The second step involves sending 79 €1 of With significantly reduced cash allowable debt is €6 for every lenders on some aspects of the the business plan to preferred When debt is secured, many inflows, businesses are poised to

EBITDA. However, it is now likely lenders will place financial and/or that a business could see its non-financial covenants on the EBITDA significantly reduced and borrowed monies. Covenants are therefore cause an increase of the essentially T&Cs/rules which the debt toDrawdown EBITDA above 6x. lender places on the loan. Standard Fulfill Prepare Sign Loan Funds is breached, a Conditions covenants When a covenant Business Plan Offer Letter will often revolve Precedents around max leverage, debt lender may invoke a penalty, servicing ratio’s and debt to increase the security, or demand EBITDA ratio. One of the primary full repayment of the loan. concerns with COVID-19 is that issues which your business impact with COVID-19 is| that cause an increase of the debt to | Taxation M&A | Dueconcerns Diligence | Disposals Valuations | Banking & Fundraising | Restructuring PCOVID-19 a g e | is1 having a major on the cash inflows of many many leveraged businesses, EBITDA above 6x. may be facing, we here at JPA businesses by effectively wiping including usually strong trading Brenson Lawlor suggest taking When a covenant is breached, out the top-line i.e. Revenue (and businesses, may now fail to meet a proactive, transparent, and therefore the bottom-line also). these covenants. For example, a a lender may invoke a penalty, sustainable approach to managing business haveany an debt agreed debt the security, demand In order tomay navigate issues whichincrease your business may beor facing, debt. There are several options With significantly reduced cash to EBITDA ratio of 6x, this means full repayment of the loan. available to businesses and many we here at JPA Brenson Lawlor suggest taking a proactive, inflows, businesses are poised that the max level of allowable lenders will be understanding of to face liquidity issues, and none transparent, and ¤1 sustainable to managing debt is ¤6 for every of EBITDA. approach Navigating Debt in thedebt. these unprecedented economic more so than businesses who are However, it is now likely available that a to businesses Currentand Crisis There are several options many lenders will conditions, Business may explore leveraged. When a business is business could seeof its these EBITDAunprecedented economic conditions, be understanding leveraged, it has debt obligations some of the following options: In order to navigate any debt significantly and therefore Business mayreduced explore some of the following options: and must service its debt, often monthly through capital and Engage in financial modelling. Financial modelling will involve projecting the trade of the business, interest repayments. Without 1 identifying the cashflows and scenario analysis. Financial modelling may be useful in helping lenders the cash inflows from sales, understand that the business case is still strong, save for these unprecedented times. businesses may soon find that they are unable to service their debt, unless they have sufficient Assess the T&C’s of all loans. Understanding the covenants and terms will help business owners cash reserves.

2 better understand their obligations and also help identify any covenants which may be at a higher risk of being breached.

Whilst many understand that businesses will struggle to service their current debt, there are other Communicate transparently with lenders. Business owners who are looking to navigate their debt considerations to debt which many 3 should proactively and transparently communicate with lenders. Clear communication channels are often overlook. the best course of action to achieving optimal solutions e.g. Loan Moratoriums. face liquidity issues, and none more so than businesses who are leveraged. When a business is leveraged, it has debt obligations Negotiate and must service its debt, often Send Business Heads of Plans tomonthly Banks through Terms capital and interest repayments. Without the cash inflows from sales, businesses may soon find that they are unable

NAVIGATING DEBT IN THE CURRENT CRISIS

When debt is secured, many lenders will place financial and/ or non-financial covenants on the borrowed monies. Covenants are essentially T&Cs/rules which the lender places on the loan.

Standard covenants will often revolve around max leverage, debt servicing ratio’s and debt to EBITDA ratio. One of the primary

4 5

Page |2

Explore refinance/restructuring options. Refinance involves applying for a new loan to repay the current loan. The new loan may have more favourable T&Cs e.g. increased loan term. A restructure involves altering the current loan agreement, this is used in more distressed situations.

Identify other sources of capital. Business owners may be able to inject some personal liquidity into the business. Business may also seek out support schemes as mentioned in our previous cashflow management article e.g. SBCI Working Capital Scheme,

M&A | Due Diligence | Disposals | Valuations | Banking & Fundraising | Taxation | Restructuring

News

FIP Fellowship for Professor Henman Associate Professor Martin Henman was recently awarded a FIP Fellowship citing his contribution to many international bodies as a leader, a researcher, a representative and as an expert.

Professor Henman has made significant contributions throughout his career in many areas including education, research and health policy. He has contributed to the work of all of the pharmacy organisations – the Pharmacy Regulator – reports concerning the Workforce, Community and Hospital Pharmacy and remediation support for pharmacists sanctioned by the Regulator; The Irish Pharmacy Union – research into services, presentations to invited audiences of government, professions and regulators concerning the

scope of pharmacist’s practice and Health Policy; the Hospital Pharmacists Association – lectures & workshops & scientific committee duties; the Irish Institute for Pharmacy – membership of the establishing committee and the Steering Committee.

Professor Henman currently serves as Director of Global Relations in the School and has established collaboration with several Universities in the USA, Europe, the Middle East and in Japan. Martin was made a Fellow, European Society of Clinical

Professor Martin Henman, Trinity College, Dublin

Pharmacy in 2013, an Honorary Life Member of the Pharmaceutical Care Network Europe in 2018 and a Visiting Professor at the Faculty of Pharmacy in the University of Belgrade, Serbia in 2019. Martin holds Adjunct Clinical Pharmacy positions in three Universities in the USA.

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Clinical R&D MERCK ANNOUNCES ¤59 MILLION ANTIBODY-DRUG CONJUGATE MANUFACTURING EXPANSION Merck, a leading science and technology company, has announced a ¤59 million expansion of its HPAPI and ADC manufacturing capabilities and capacity at its facility near Madison, Wisconsin, USA. This investment will allow large-scale manufacturing of increasingly potent compounds for therapies that have the potential to treat cancer. Completion is expected by mid-2022 and should add approximately 50 full-time jobs starting in 2021.

"ADCs have posted incredible growth over the last decade, and regulatory agencies' approvals in recent years demonstrate their promise as a targeted therapy," said Andrew Bulpin, head of Process Solutions, Life Science, at Merck. "With more than 35 years of experience in this space, we have been a frontrunner in the development and manufacturing of biologics, conjugation processes and small molecules.

This investment underscores our commitment to working with innovators to bring new treatments to patients quickly and more efficiently."

Merck's new 6,500-square meter commercial building will be one of the largest dedicated HPAPI manufacturing facilities specifically designed to handle single-digit nanogram occupational exposure limit materials. The project is in addition to the company's Madison campus, which was the first commercial ADC facility in North America designed to handle highly active materials. The new building will join Merck's established campus in St. Louis, Missouri, USA, which specializes in ADC bioconjugation, active pharmaceutical ingredients, excipient and adjuvants manufacturing.

While ADCs can provide many benefits compared with other therapeutic options, they also present a unique set of challenges. Their development is complex, necessitating stringent containment infrastructure, and their structural exceptionality requires expertise in a number of different technologies for small and large molecules, as well as analytical capabilities. Due to these challenges, more than 70 percent of ADC projects are outsourced to contract development and manufacturing organisations.

With more than 35 years of experience in the development and manufacturing of small molecules, biologics and ADC technologies, Merck offers extensive experience in both clinical and commercial manufacturing. The company's comprehensive service portfolio

combines the steps of drug development and production — from pre-clinical to commercial — from a single source. This consolidation helps reduce risk and streamlines the process of getting therapies to patients faster.

LARGE PROSPECTIVE LUNG CANCER STUDY TO BE PRESENTED AT ESMO CONGRESS Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), has announced that a large prospective lung cancer study, co-supported

by AstraZeneca, a global scienceled biopharmaceutical company (LON: AZN), has been selected to be presented at the renowned European Society for Medical Oncology ('ESMO') Virtual Congress taking place between 19-21 September 2020. Rapid and accurate EGFR mutation testing is essential to make informed treatment decisions for patients with advanced non-small cell lung cancer (NSCLC), and the study concluded that Idylla™ reduced turnaround time by more than a week versus reference methods, allowing earlier patient management decisions.

The FACILITATE study is a large, prospective, real-world data set study across 16 European sites3 that was launched as part of the agreement between Biocartis and AstraZeneca4, aimed at obtaining faster lung cancer molecular diagnostic biomarker results in Europe. Between January 2019 and July 2020 a large set of 1,370 advanced non-small cell lung cancer (NSCLC) patient samples were tested using the Idylla™ EGFR Mutation Test5 (CE-IVD) and local reference methods6 including targeted next-generation sequencing (NGS). Results showed a 97.6%7 overall percentage agreement between Idylla™ and reference methods. Ninety percent of all samples were tested in less than 7 days using the Idylla™ technology, versus less than 21 days using the reference methods.

This demonstrates that Idylla™ improves turnaround time, allowing for fast-track testing when required, complementary to slower existing laboratory processes and systems.

Herman Verrelst, Chief Executive Officer of Biocartis, commented, "A large study with a broad data set such as this one with our partner AstraZeneca, who is at the forefront of lung cancer treatment, shows once again how Idylla™ can make a significant improvement for patients. With Idylla™, a fully automated rapid EGFR mutation diagnostic workflow8 becomes possible, decreasing testing turnaround time and allowing earlier patient management decisions, following diagnosis."

PRASINEZUMAB SLOWS PROGRESSION ON MEASURES OF PARKINSON'S DISEASE IN PHASE 2 STUDY Prothena Corporation plc (NASDAQ:PRTA), announced that results from the Phase 2 PASADENA study of prasinezumab have been highlighted at the International Parkinson and Movement Disorder Society's MDS Virtual Congress 2020 (MDS Congress). Prasinezumab is the first potentially disease-modifying, anti-alpha-synuclein antibody to demonstrate signals of efficacy on multiple pre-specified secondary and exploratory clinical endpoints in patients with early Parkinson's disease. As previously reported, the study did not meet the primary objective, but signals of efficacy showing a reduction in disease progression were observed in both of the prasinezumab arms when compared to placebo. In the study, prasinezumab significantly reduced decline in motor function by 35% (pooled dose levels) vs. placebo after one year of treatment on the centrally rated assessment of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, a clinical examination of motor function.

Motor symptoms associated with Parkinson's disease include slowness of movement (bradykinesia), tremor, rigidity, and gait. Prasinezumab-treated patients also demonstrated a significant delay in time to clinically meaningful worsening of motor progression on the site rated assessment of time to at least a 5-point progression on MDS-UPDRS Part III vs. placebo over one year, with a hazard ratio of 0.82 (pooled dose levels). There are currently no treatments available that target the underlying cause of Parkinson's disease and can slow its progression.

The clinical results have been posted online on the MDS Virtual Congress website as an ePoster in the Virtual Poster Hall and were also presented by Roche on Tuesday, September 15, as a Top Abstract oral presentation.

Prothena conducted an investor webcast on Tuesday, September 15 at 1:30PM ET. Prasinezumab is being developed through a worldwide collaboration between Prothena and Roche.

"Our expectation that both dose levels tested would saturate aggregated alpha-synuclein in the brain was confirmed by the similar outcomes across multiple endpoints in both prasinezumab arms of the study after a single year of treatment, including a significant 35% reduction in motor function decline in patients with early Parkinson's disease versus placebo, a significant delay in time to clinically meaningful worsening of motor progression,

81

and other clinical endpoints such as bradykinesia, that assess activities impacted in patients with Parkinson's disease," stated Gene Kinney, PhD, president and chief executive officer of Prothena.

"We are further encouraged to see consistent signals favoring prasinezumab across other secondary and exploratory endpoints. In totality, these clinical results support further clinical development of prasinezumab to assess its potential as a first-inclass disease-modifying therapy to slow progression of Parkinson's disease, and add to the growing body of clinical evidence that selective and specific targeting of pathogenic proteins implicated in a wide variety of central and peripheral disorders has the potential to fundamentally change the course of these devastating diseases."

DATA FROM PRECLINICAL STUDIES OF MRNA-BASED VACCINE CANDIDATE AGAINST COVID-19 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, "BioNTech") has announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. In a non-human primate preclinical study, immunization with BNT162b2, a nucleosidemodified messenger RNA (modRNA) candidate, protected rhesus macaques against SARSCoV-2 infection. The manuscript describing these preclinical data is available on the preprint server bioRxiv and is concurrently undergoing scientific peer-review for potential publication.

In the preclinical study, BNT162b2 demonstrated protective anti-viral effects in rhesus macaques, with concomitant high neutralizing antibody titers and a TH1-biased cellular response in rhesus macaques and mice. In a viral infection model, macaques that received two injections with 100 µg BNT162b2 and macaques that received saline control injections were challenged 55 days after the second immunization with a very high viral inoculum of approximately 1 million plaque-forming units of SARS-CoV-2, via both intranasal (nose) and intratracheal (lung) routes. Immunization with BNT162b2 reduced viral infection with no viral RNA detected in the lower respiratory tract of the immunized animals, while in most non-immunized (saline) animals, there was evidence of viral RNA. Importantly, BNT162b2 induced potent SARS-CoV-2 neutralizing antibodies in vaccinatedmacaques, and viral antigen-

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Clinical R&D

specific CD4+ and CD8+ T cells.

Rhesus macaques (2- to 4-yearold males) were immunized by intramuscular (IM) immunization with 30 µg or 100 µg of BNT162b2 or saline control on Days 0 and 21 (2 doses). After two immunizations, neutralization titers were detectable in rhesus sera with geometric mean titers of 962 (on Day 35 for the 30 µg group) or 1,689 (on Day 28 for the 100 µg group). Neutralizing antibody titers persisted to at least day 56, with higher geometric mean titers (GMTs) than those in a panel of human convalescent sera.

BNT162b2 vaccination elicited a high frequency of CD4+ T cells that produced IFN-ɣ, IL-2, and TNF-α, and almost no IL-4 producing CD4+ cells were detectable, indicating a TH1-biased response, which is an immune profile thought to promote vaccine safety. BNT162b2 also elicited spike-specific IFN-ɣproducing CD8+ T cell responses, which is thought to promote an anti-viral effect.

In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, 1, or 5 µg) generated B- cell and T- cell immune responses in BALB/c mice, and SARS-CoV-2 pseudovirus neutralizing activity increased steadily to Day 28, the last day for which titers are reported.

CD4+ and CD8+ T- cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN-ɣ and IL-2, producing high levels of the TH1 cytokines but minute amounts of TH2 cytokines, suggesting a robust, TH1-biased T cell adaptive immune response.

Many of these preclinical data and the Phase 1 clinical results contributed to the decision by Pfizer and BioNTech to commence the global (except for China) Phase 2/3 safety and efficacy portion of clinical study C4591001 to evaluate potential prevention of COVID-19 disease by BNT162b2. The Phase 2/3 study has enrolled over 25,000 participants 18 to 85 years of age in the U.S., Argentina, and Brazil.

Additional enrollment is planned in Germany, Turkey and South Africa.

The study is an event-driven trial.

Pfizer and BioNTech are committed to decreasing health disparities in underrepresented populations through the clinical trial process.

To that end, many investigator sites are in diverse communities that have been disproportionately affected by COVID-19 so that individuals who have been most impacted have the opportunity to participate. The companies are also working together with investigator sites and advocacy partners to raise awareness about the importance of participation in this trial.

BNT162b2 remains under clinical study and is not currently approved for distribution anywhere in the world. Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

ACCORD HEALTHCARE LAUNCH INNOVATIVE PATIENT FOCUSED APP

administration instructions, which includes an animated video and step-by-step instructions.

Following on from the successful launch of its patient-activated, pre-filled injector (PFI) to deliver pegfilgrastim (Pelgraz® ), Accord Healthcare are delivering another first, with the launch of their Pelgraz® support app in Ireland.

The symptom tracker allows patients to log their side-effects and symptoms post-chemotherapy and track them over a given period, providing the patient with the tools and information to have an in-depth conversation at their subsequent meeting with their healthcare professional should they wish.



The app is designed specifically for patients who have been prescribed Pelgraz® PFI. “We appreciate that patients undergoing treatment for cancer can feel like they have very little control over their illness and we believe it is important to give patients back some sense of control. We have therefore developed our app to help give patients the confidence to self-administer their treatment from the convenience of their own home, while offering them the peace of mind that they are complying with their prescribed treatment regimen”, says Mr Tony Hynds, Managing Director, Accord Healthcare Ireland Ltd. The app supports patients to administer their medication at the correct time and in the correct way. It also provides relevant educational content and the ability to track side-effects along with highlighting how to report any sideeffects. The app allows a patient to set a reminder to administer their treatment, based on when their last chemotherapy session took place and when the clinician indicated to use the product.

Once the reminder is opened, the app automatically presents the

The ethos behind Accord’s Pelgraz® PFI launch is to give patients the confidence to administer pegfilgrastim from the comfort of their own home.

With pegfilgrastim administered at least 24 hours after cytotoxic chemotherapy, patients will often have to return to hospital or await a visit from a home care nurse to administer pegfilgrastim.

“Evidence shows that travelling to and attending hospital visits are one of the major contributing factors that negatively impact the quality of life for people living with cancer. Reducing the number of times that a patient must visit the clinic or hospital, at a time when they are living with the side-effects of chemotherapy and when their immune systems are compromised, must be a priority for patients and their healthcare team. Being able to offer the option of spending more time at home during chemotherapy treatment is something I know patients genuinely welcome,” said Professor Hartmut Link, Professor of Medicine, external faculty at University Medical Centre, Hannover, Germany.

Pharmacist Vacancy – Tullyallen Pharmacy Tullyallen Pharmacy is an Independent Community Pharmacy located in the village of Tullyallen, Co. Louth which is just of the M1 on the northern outskirts of Drogheda. With commuting times of 45 minutes from Banbridge, 30 minutes from Newry, 20 Minutes from Dundalk and 30 minutes from Dublin it is well suited to pharmacists located along the M1 corridor. The pharmacy is located in a small shopping complex with a GP surgery above it and has a good mix of GMS, private and OTC sales. It has a well established, performing team and is customer focused to deliver service above and beyond the average.

It values its staff, invests in them and supports them in their development. So if you are ready for a fresh challenge and to experience community pharmacy as it can be and should be - contact us about joining our team.

Supervising Pharmacist - Job Type: Full time (4-5 days per week), Permanent Supervising Pharmacist required in Tullyallen Pharmacy, Louth • Minimum 3 years experience in a retail environment • Bright, enthusiastic and positive outlook on how you do your job.

• Our ideal candidate would be customer-focused with a friendly disposition • Must have an interest in managing the shopfloor with an ability to work with in a team to drive sales and maintain an efficient dispensary • Good prioritising, multi-tasking and organisational skills • Be confidential and empathetic to our Customer needs.

• Must have a strong work ethic • Be a team player and fit into a settled performing team.

• No late nights or Sundays, cover for a minimum of four full days a week with Saturdays off in rotation • No nursing homes or methadone • Friendly, interested support staff • Supervising pharmacist package available for this position if candidate has suitable experience and motivation We can offer you a competitive reimbursement package and a fulfilling role in a friendly team environment.

If interested, send a cover email outlining why you are the most suitable candidate for the position and a full CV including experience, qualifications and any added value you will bring to the role. Applications to be sent FAO Dermot to pharmahealthpromotion@gmail.com Closing date for applications Wednesday 14th October 2020. Interviews will take place the following week with successful candidate expected to start 1st December 2020 at latest.

PHARMACYNEWSIRELAND.COM

NEW

TREATS HEARTBURN AND ACID REFLUX. ONE TABLET PER DAY. LASTS 24 HOURS. AVAILABLE IN PACKS OF 7s AND 14s.

Marketed by

CCF:22656 Date of preparation: (10-19)

ABBREVIATED PRESCRIBING INFORMATION Product Name: Emazole Control 20 mg Gastro-Resistant Tablets Composition: Each tablet contains 20 mg esomeprazole (as magnesium dihydrate).

Description: Light pink oval film coated tablet.

Indication(s): Proton Pump Inhibitor (PPI): Short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults. Dosage: Swallow tablets whole with liquid, do not chew or crush. Disperse in half a glass of non-carbonated water if difficulty in swallowing. Stir until tablets disintegrate, drink liquid with pellets immediately or within 15 min, or administer through a gastric tube. Do not chew or crush pellets. Adults: The recommended dose is 20 mg esomeprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Duration of treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. Elderly (≥ 65 years old): As per adults. Paediatric population (< 18 years): Not recommended. No relevant use in this group in the indication: “short-term treatment of reflux symptoms (e.g., heartburn and acid regurgitation)”. Severe impaired renal function: Caution. Severe liver impairment: 20 mg max daily dose.

Contraindications: Hypersensitivity to esomeprazole, substituted benzimidazoles or any of the excipients. Not with nelfinavir. Warnings and Precautions for Use: On demand treatment: Contact a physician if symptoms change in character. In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with esomeprazole may alleviate symptoms and delay diagnosis. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium difficile. Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Absorption of vitamin B12 may be reduced due to hypo- or achlorhydria. Not recommended for long-term use as the following may also occur: Hypomagnesaemia; Risk of fracture. Consider stopping Emazole Control in cases of Subacute cutaneous lupus erythematosus (SCLE) accompanied by arthralgia. Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Emazole Control treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of PPI treatment. Contains glucose and sucrose.

Interactions: Effect of esomeprazole on other drugs: Co-administration with atazanavir is not recommended. If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded. Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. Serum levels of cilostazol, cisapride, tacrolimus, methotrexate may be increased. An interaction is observed between clopidogrel and esomeprazole, but the clinical relevance is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged. Gastric acid suppression by PPIs increase or decrease absorption of drugs with pH dependent absorption (decreased absorption of ketoconazole, itraconazole); esomeprazole inhibits CYP2C19 metabolising enzyme and could increase plasma concentrations of diazepam, citalopram, imipramine, clomipramine, phenytoin (monitor plasma levels of phenytoin), etc. resulting in need of a dose reduction; monitor INR when given with warfarin or similar. Caution as absorption of digoxin can increase. Effect of other drugs on esomeprazole: CYP2C19 and CYP3A4 inhibitors (clarithromycin, voriconazole) may increase the esomeprazole exposure. Dose adjustment not regularly required, except in severe hepatic impairment and long-term use. CYP2C19 and/or CYP3A4 inducers (rifampicin and St. John’s wort) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism.

Pregnancy and Lactation: Caution in pregnancy due to lack of clinical data. No studies in lactating women, therefore, not recommended during breast-feeding. Ability to Drive and Use Machinery: Minor influence on the ability to drive or use machines. Adverse reactions such as dizziness (uncommon) and blurred vision (rare) have been reported. If affected, patients should not drive or use machines.

Undesirable Effects: Common: Headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign). Uncommon: Peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, dry mouth, increased liver enzymes, dermatitis, pruritis, rash, urticaria, fracture of the hip, wrist or spine. For other side effects refer to the SPC. Marketing Authorisation Holder: IQ Pharmatek Ltd., Gurtnafleur, Old Waterford Road, Clonmel, Co. Tipperary. Marketing Authorisation Number: PA 22777/001/001. Further information and SPC are available from: Rowex Ltd, Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417. E-mail rowex@rowa-pharma.ie Legal Category: Not subject to medical prescription.

Date of Preparation: September 2019 Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie) or by emailing medsafety@hpra.ie or by emailing Rowex pv@rowa-pharma.ie

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