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October 2018 Volume 10  Issue 10

THE INDEPENDENT VOICE OF PHARMACY Irish Pharmacy Advert A5 Front Cover_FA_OL.pdf

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14/09/2018

16:04

In this issue: NEWS: PSI Council meeting approves ¤1.2m digital transformation Page 4

NEWS: Major pharmacy training partnership with Chinese university announced Page 6

NEWS: Local pharmacies embrace e-commerce Page 24

CONFERENCE: Drug regulators from across the world gather in Dublin Page 28

CPD: Parkinson’s Disease Page 31

FEATURE: Improving outcomes for those with psoriasis Page 40

REPORT: Raising awareness of Falsified Medicines Directive Page 46 1


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Foreword

Contents

One of the biggest changes in the supply of medicines within the EU in recent years is due to be implemented early next year with the introduction of the Falsified Medicines Directive (FMD).

Page 6: Forum to discuss challenges in the biosimilar industry

In this month’s packed edition of Irish Pharmacy News we begin a substantial series looking at what the directive is and how it will change how you do business. The reason for the FMD is clear, health regulators and other authorities are having to innovate to keep up with rogue actors and criminals and it is estimated that globally up to 10% of medicines are substandard or falsified (SF).

Page 28: EU fortunate to have fully integrated drugs regulation

Also October’s edition of IPN takes a fascinating look at the life of a locum pharmacist. The locum is an integral cog in the wheel of community pharmacy and we have spoken to two highly experienced locums who discuss the opportunities and challenges that they meet on a daily basis.

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Page 36: The life of a pharmacy locum Page 38: Newly elected IPHA President wants to ‘speed up patient access’ to innovative medicines Page 46: Pharmacists prepare for FMD deadline

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Page 56: Irish drugmaker sold for ¤540m

PUBLISHER IPN Communications Ireland Ltd. Clifton House, Fitzwilliam Street Lower, Dublin 2 00353 (01) 6690562 MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com EDITOR Jonny McCambridge editorial@ipnirishpharmacynews.ie JOURNALIST Áine Carroll editorial@irishpharmacynews.ie CONTRIBUTORS Eamonn Brady Andrew Jennings Sarah Whitehead

Regulars

IPN has been on the road in the last month covering the major conferences and events that matter to the community pharmacist. This includes the recent International Conference of Drug Regulatory Authorities 2018 (ICDRA). More than 500 delegates from more than 100 countries attended the event. Recommendations from ICDRA conferences provide regulators and the WHO with a roadmap for developing future policy decisions. Also we have been in attendance at the Retail Excellence Pharmacy Management Programme. The objective of this two day programme was to inspire delegates to operate the best performing and most profitable pharmacy business. The programme was designed specifically for pharmacy owners and pharmacy managers and a full report appears in this edition of IPN. This edition is packed with news as well. The Irish Pharmacy Union is leading a call for VAT to be scrapped on condoms. They have referred to it as a ‘tax on safe sex’ and made the call in their annual pre-budget submission.

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Meanwhile, an exciting new partnership signed between the RCSI and Soochow University in China will allow for the development of a joint pharmacy training programme. This programme, the first of its type for pharmacy in Ireland, will see students spend the first two years of their studies at Soochow University where they will undertake a number of core foundation modules across pharmaceutical sciences, anatomy, physiology, medicinal chemistry and pharmacology.

Irish Pharmacy IRISH News is circulated PHARMACY NEWS to all independent, multiple and hospital 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.

PROFILE FEATURE – OLDER GENERATION

October’s IPN also features the usual wide array of features and clinical articles. Do you have a news tip? Is there a community pharmacy topic you would like to see featured in Irish Pharmacy News? Do you know someone in your business going the extra mile to promote best practice in Irish community pharmacy? Email editorial@irishpharmacynews.ie

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FEATURE – FAMILY PLANNING

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FEATURE – PSORIASIS

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CPD – PARKINSON’S DISEASE

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CLINICAL PROFILES

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News PSI Council meeting approves ¤1.2m digital transformation A €1.2 million digital transformation is set to revolutionise how the Pharmaceutical Society of Ireland (PSI) handles the data it receives in relation to pharmacies and other aspects of its operations. A recent meeting of the PSI Council heard that the “power of data is considerable” as a business case was presented about how “information silos” are created when data is held in many different places, such as in spreadsheets, documents, databases, emails, paper and even “in people’s heads”. If a very experienced member of staff leaves or retires the information is lost. In practical terms, this creates a risk. Single Customer View (SCV) will show a complete digital overview of the regulatory environment, allowing more time to be spent on analysing than collecting data, in brief: the IT and applications update will give employees more time to spend on the business of regulation as opposed to spending time on managing data. The spend, to be taken from PSI reserves, was approved. Also at the meeting Council member Michael Lyons asked if the communication of the Valsartan recall could have been handled better. Given that recalls

are a regular occurrence and that it was at pharmacy level and not patient level, some pharmacists on the Council raised concerns that the media had the information before any official communication had been received by their dispensary. Members shared that in some cases the public were telling pharmacists about the development.

the rules effectively ends a longstanding agreement between the governing bodies (which preceded the PSI in its current format) and the remaining 248 registered pharmaceutical assistants.

Registrar Niall Byrne said the PSI was “always learning how best to respond” but that the communication of the recall was not technically an issue for PSI. Byrne encouraged pharmacists to raise the matter with the HPRA and said the pharmacy regulator would look into developing a better flagging system in an effort to get information to pharmacists more efficiently.

“The 2007 Act has changed the general statutory context within which the interpretation to be given to the phrase ‘temporary absence’ falls to be considered as the phrase must be costumed narrowly, as it is designed to put in place an exception to the general prohibition on operating a pharmacy without a pharmacist being present. The Working Group understood that the Act clearly empowers the Council to define what is meant by temporary absence and it is a matter for the Council, acting reasonably, to define this. The expectation of a patient that a pharmacist be accessible and operating within a pharmacy is conserved in the legislative framework, and the

Also significant on the day was the consideration of responses arising from the public consultation process and approval of the rules recommended by the Working Group on Temporary Absence Rules. If accepted by the Minister for Health, approval of

An excerpt from the April 2018 Working Group report outlines the rationale behind changing the definition of ‘temporary absence’:

PSI in the context of its core Corporate Objective to assure trust in pharmacy services is to define for how long it thinks it is acceptable for a registered Retail Pharmacy Business to operate in the absence of a pharmacist.” Council accepted the proposed rules, which have now been sent to the Minister for approval. Members of the Pharmaceutical Assistants Association (PAA), who were seated in the public gallery, collectively walked out and the meeting was temporarily adjourned. PAA later released a statement, claiming that the narrowing of the definition of what a temporary absence means, in real terms, is that their PA qualification is now redundant for all but one hour of the day. This is despite the fact that some of them have been dispensing medication in the same community pharmacy for up to 35 years. Hospital pharmaceutical assistants will also be affected by the changes. • Full report, page 12

Parents respond well to HPV ‘trusted source’ information campaign Minister for Health Simon Harris TD welcomed the increase in HPV uptake rates at the launch of the 2018-2019 campaign in September, saying this reflected the work carried out at all levels of the health service, including by pharmacists, “to provide accurate and trusted information” to parents. are now protected against most cervical cancers and the Minister outlined plans to extend the vaccination to boys.

Health Minister Simon Harris

The uptake rate fell to 51% in 2017 and the 2018 figure has risen to an encouraging 65%, following Minister Harris’s comment last year that anti-HPV campaigners were carrying out “emotional terrorism.” Two in every three girls

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“Extending the national immunisation schedule to include HPV vaccination of boys is a priority for me, and subject to a favourable recommendation from HIQA, the Government will seek to extend this vaccine universally as a priority. Today, I want to be unequivocal again in saying that the HPV vaccine protects young people's lives and I urge parents to vaccinate their daughters this autumn." The HIQA recommendation on extending the vaccine to boys is expected to be made later this year. The 15% increase on last year’s uptake rate is “extremely encouraging” according to the Interim Head of the HSE National Immunisation Office, Dr Sean

Denyer. He said, “We know this vaccine is safe; we know it works and we are now seeing the majority of parents throughout the country move to protect their daughters. We understood that parents wanted to do the right thing for their children, so we set out to provide them with scientifically and evidence-based information. “We encouraged them to speak directly with the school vaccination teams, their local GPs and their local pharmacists. We provided a trusted source of information through hpv.ie. Clearly, they have responded and now as we move into a new school year with a new group of first year girls, we are reaching out to a new set of parents, inviting them to access information through those same trusted sources and encouraging them to ensure their daughters are vaccinated. We are also reminding

parents that a catch-up facility is available so anyone who may have hesitated previously can contact our schools teams and get their daughter vaccinated.” A communication from the HSE confirms that the WHO acknowledged recently “the work that has been carried out in Ireland and Denmark” to address the sharply falling uptake rates. Increasing rates are steady across all regions of the country and there has been a “significant number of requests from parents who had previous[ly] refused the vaccine for their daughters.” Ireland has one of the highest rates of cervical cancer in Western Europe and more than half of women are diagnosed when they are under 50 years of age.


News LloydsPharmacy expand flu vaccination service to 52 pharmacies nationwide In 2011 pharmacists were legally permitted to provide a seasonal influenza vaccination service and to supply and administer adrenaline. Since then, the uptake on the vaccine has increased year on year. Out of a national total of almost 130,000 vaccines administered in 2017, LloydsPharmacy administered over 2,500 of these over 31 pharmacies. This year the company has expanded the service and will offer the seasonal flu vaccine to patients in 52 locations around the country. Irish Pharmacy News spoke with Denis O'Driscoll, who is a tutor vaccinator and Superintendent Pharmacist at LloydsPharmacy, about running a successful vaccination campaign. "Making sure each member of the team buys into the service is key: from pharmacists to OTC staff, all colleagues need to be willing, competent, and trained as per the requirements in the legislation. At LloydsPharmacy we have very high standards and ensure that standard operation procedures are adhered to. When your colleagues are confident in the service they are providing it gives patients confidence." O'Driscoll explains that pharmacies are actually increasing overall vaccination rates. "People find it very convenient that they can go to their local pharmacy and receive the vaccine, sometimes

with no appointment. Opening hours are flexible, and research from the Pacific Research Institute published in 2018 demonstrates that pharmacies are actually increasing overall immunisation rates, and this is not having an effect on the uptake at other healthcare vaccinating providers, such as in local GP practices. Initially when pharmacies began offering the service the uptake was slow but the numbers of people who are requesting this service is increasing steadily. We started with a small base, so considering these factors the growth in the pharmacy uptake rate has been significant." O'Driscoll tells IPN that the public often forget that the seasonal influenza is a notifiable illness. "The flu can be a very serious illness. In 2009 the European Council recommended that inoculation rates among the

groups who are at high risk of complications from seasonal influenza should be at 75 percent, so from a public health perspective the pharmacy vaccination programme is a very important initiative. It is also a great way to engage at-risk patients, and this is especially true in rural areas where people find it easier to go to their local community pharmacy than going to visit their GP. Atrisk groups need to be targeted and, in this respect, pharmacy vaccination programmes may help people to overcome any barriers they might face when accessing healthcare. I feel very strongly that by successfully managing our seasonal influenza campaign we are empowering staff to promote accessible healthcare and even though it requires some logistics to make sure everything is set up correctly, it an extremely effective initiative."

Irish patients denied access to cancer and heart disease drugs Irish patients are being denied access to a range of different cancer and heart disease medicines because the drugs are still awaiting approval to be used in the Irish system. According to figures published by the Irish Pharmaceutical Healthcare Association (IPHA), 10 medicines cannot be used here because they have been working through the approvals process for more than two years. All of the medicines have gone through assessments to measure their clinical effectiveness, safety and cost effectiveness. Seven of the drugs are cancer medicines, two are for cardiovascular disease and one is a musculoskeletal treatment. The data shows that the seven cancer treatments are available in approximately a dozen other western European countries. Four of these medicines are for lung cancer which is among the top five most commonly diagnosed cancers in Ireland. Around 2,500 Irish people are diagnosed with the

disease each year, according to the Irish Cancer Society. The data is revealed in the IPHA’s second bulletin benchmarking medicines’ availability in Ireland compared to other EU countries. The IPHA represents the research-based pharmaceutical industry in Ireland.

“That medicines for cancer and heart disease, Ireland’s two biggest killer diseases, feature so prominently in the list is very

MAN CHARGED OVER PHARMACY ROBBERIES IN SOUTH DUBLIN A man has been charged over two robberies at pharmacies in south Dublin which took place in the same week. The first robbery occurred on 27 August at a premises on Terenure Road North at 6.10pm. A man threatened staff at knifepoint and demanded cash and medicine. He left the scene on a blue mountain bike. The second incident was at a pharmacy on Harold's Cross Road on 30 August. A man wearing a black hoodie and grey tracksuit bottoms, carrying a grey/black bag threatened staff at knifepoint and demanded cash and medicine. Gardaí arrested and charged a 43-year-old man in connection with these two robberies. He appeared in the Central Criminal Court in Parkgate Street.

CHOCOLATE GOOD FOR THE HEART: STUDY Eating chocolate in moderation could cut down the risk of heart failure, a new study suggests. The research, presented at the European Society of Cardiology annual congress in Germany, found people who ate one to three servings of chocolate a month had a 23 percent lower risk of developing heart failure compared to those who ate no chocolate at all. But the study also found that people who ate one or more servings of chocolate a day had a 17 per cent higher risk of heart failure.

Oliver O’Connor, IPHA Chief Executive, said the figures show that no progress has been made since the last quarter. “This is very frustrating, both for clinicians and patients, because it shows that Ireland continues to be among the slowest countries in western Europe to be able to access and reimburse innovative medicines,” he said.

news brief

IPU Pr IPHA Chief Executive Oliver O'Connor concerning. The Government’s National Cancer Strategy aims to place Ireland in the top quartile of European countries for cancer survival in the next decade. The persistent logjam in approving cancer medicines will make it hard for Ireland to hit that target.”

The researchers, who reviewed three studies involving more than half a million people, said dark chocolate and cocoa intake was associated with a reduced risk of cardiovascular disease and cardiovascular mortality. “The present study confirms the association of high chocolate consumption with the risk of heart failure. In contrast, moderate chocolate consumption may reduce the risk of heart failure,” the authors said.

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News RCSI signs transnational collaborative agreement with Soochow University for the delivery of joint pharmacy programme RCSI President, Mr. Kenneth Mealy and RCSI CEO, Professor Cathal Kelly have signed a transnational collaborative agreement with Professor Sidong Xiong, President of Soochow University, and Professor Xuechu Zhen, Dean of the College of Pharmaceutical Sciences, in Suzhou, Jiangsu, China for the delivery of a joint programme in pharmacy.

The RCSI Soochow University Agreement signing This programme, the first of its type for pharmacy in Ireland, will see students spend the first two years of their studies at Soochow University where they will undertake a number of core foundation modules across pharmaceutical sciences, anatomy, physiology, medicinal chemistry and pharmacology. There will also be two modules led and delivered by RCSI faculty at Soochow University. Students then have the option to transfer to RCSI-Dublin to complete a further two years of study with a more specific focus on clinical pharmacy. At the end of their four years of study, students will be awarded dual degrees from RCSI and Soochow University.

Speaking at the signing in China, Mr. Kenneth Mealy, President, RCSI, said: “This collaboration with Soochow University College of Pharmaceutical Sciences began in April 2015 when RCSI signed a Memorandum of Academic and Research Cooperation and since then there has been significant engagement and collaboration with RCSI across both education and research initiatives. We are delighted today to see the further development of our relationship with the signing of this agreement and we look forward to continuing to work with Soochow University on further initiatives in the future.” Professor Sidong Xiong, President, Soochow University,

said: “Soochow University is committed as a strategic priority to internationalization. Ireland has a very established reputation in higher education and so I am delighted to sign this agreement with such an established provider of health professions education in Ireland.”

of Pharmaceutical Sciences, and Professor Weipeng Wang, Vice-Dean for Undergraduate Studies. Professor Gallagher and Dr. Kelly were supported in RCSI by the Office of Corporate Strategy, led by Michael McGrail, with assistance from Maura Geraghty and Jean O’Neill.”

Professor Cathal Kelly, CEO, RCSI, remarked: “This Transnational education partnership between Soochow University and RCSI illustrates the changing political, social and cultural terrain of global higher education. This partnership, by combining the expertise of our two institutions, creates collaborative advantage and prepares a new generation of pharmacists for their expanded clinical role within the Chinese healthcare system.”

Professor Xuechu Zhen, Dean of the College of Pharmaceutical Sciences, Soochow University added: “I am delighted that the Joint programme will shortly commence. I wish to thank Professor Paul Gallagher and Dr. Helena Kelly for their tremendous efforts and endless input without which this agreement would not have happened.”

“I would like to extend my thanks to Professor John Waddington for establishing this relationship and I would like to offer my congratulations to Professor Paul Gallagher and Dr. Helena Kelly of the School of Pharmacy for their efforts in developing this programme in conjunction with their colleagues in Soochow University, in particular Professor Xuechu Zhen, Dean of the College

Founded in 1900, Soochow University, located in the Jiangsu province, is ranked in the top 5% of Chinese universities. The Jiangsu province has a population of 79 million and is a heavily industrialised region neighbouring Shanghai. It is considered the most developed of the 22 provinces in China. It has a Gross Domestic Product (GDP) in excess of $1 trillion and has the largest level of Foreign Direct Investment (FDI) of any province.

Forum to discuss challenges in the biosimilar industry Ireland holds the rather unflattering record of being the second worst in the EU for Biosimilar use. Despite the fact that we are lagging seriously behind our EU neighbours in terms of take-up of biosimilars, there has still been an estimated €1.5billion in savings since 2006. With the adoption and implementation of biosimilars set to remain a hot topic in Ireland, The Pharmaceutical Managers’ Institute are hosting a National Biosimilars Forum on Thursday October 25th. The event will take the form of a mini masterclass session with several experts from the world of biosimilars who will provide insights and expertise to our members on what’s currently happening in the biosimilars industry and the pipeline of biosimilars. There will also be discussions on the challenges and opportunities facing the industry and what’s expected to come over the next 12/24 months. With expert speakers representing biosimilars, originators, clinicians and the payer, this event will be a

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must-attend for anyone interested in staying informed about the future of healthcare. Speakers include: Kavya Gopal – Head, Specialty with Sandoz & Chair of British Biosimilars Association. Gopal is the Head of Specialty Business with Sandoz UK (Novartis) and the Chair of the British Biosimilars Association.

at the HSE - Dr Adms is the Chief Pharmacist with the HSE. In early 2017, she was seconded as Chief Pharmacist to the National Drugs Management Programme (Acutes) to manage high cost Drugs in the acute division.

Paul Harmon, Senior Director, European Oncology Biologics Lead with Mylan - Harmon is the Senior Director, European Oncology Biologics Lead with Mylan. He has over 20 years experience in pharmaceuticals and healthcare across Ireland, UK and Europe. Harmon has held senior roles in Cephalon and Teva – most recently holding the role of European Head of Oncology Specialty Medicine & Transplant based in Amsterdam.

Professor Michael Barry, Clinical Director with the National Centre for Pharmaeconomics - Professor Barry is a Consultant Clinical Pharmacologist and Head of the Department of Pharmacology & Therapeutics at the University of Dublin, Trinity College. He is the clinical director of the National Centre for Pharmacoeconomics, and a member of a number of National Committees on pricing and reimbursement of medicines. Professor Barry chairs the New Drugs Committee and the Medication Safety Committee at St. James’s Hospital, Dublin.

Dr Roisin Adams, Chief Pharmacist

Dr Paul Cornes, Consultant

Oncologist - Cornes is an Oncologist based in Bristol, UK and was part of the team that developed and presented evidence for the first successful US biosimilar to the Oncology Advisory drugs Committee of the FDA. Todd Manning, General Manager at Abbvie Ireland - Manning is the General Manager with Abbvie Ireland, a role he’s held since January 2015. He has previously held several key roles with Abbvie in both France and Canada. Todd holds a chemistry degree. PMI members can book their seats directly at www.thepmi. com/events. Any queries can be directed to their Commercial Manager Fiona Dunphy at fiona.dunphy@thepmi.com. This will be a must-attend event for anyone interested in the future of healthcare in Ireland.


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Profile

City centre pharmacy meets the challenges of new era head-on Conefrey’s Careplus pharmacy is on a corner of Dublin’s iconic Pearse Street. Surrounded on one hand by history and on the other by modernity, Conefrey’s has managed to make the most of this conflict and has retained its position as a stalwart of the community. Pharmacist and proprietor Tomás Conefrey’s relationship with the shop, and with pharmacy, started when he was just a child. “This is a family business and it’s been open since 1955. My late father set it up. I studied pharmacy in the University of Sunderland and when I qualified I came back home and I’ve been working here for the past 20 years. We used to be in here when we were small and now my own children come in, so there’s a real family dynamic to the place. When we were growing up, we had this extra member of the family and it was called ‘the shop’. It was always ‘how’s the shop?’” Conefrey tells Irish Pharmacy News. Tomás Conefrey’s mother, Mrs. Conefrey, still works behind the counter serving Dublin’s inner city community and despite the constantly changing economy and the ever-changing nature of Dublin city itself, Conefrey’s is one constant that the local community can rely upon. The demographic includes working class inner city families and bankers on their lunch breaks from the many international corporations that surround the premises. Conefrey knew that in order to keep up with the competition, he had to get the building under control. “Around five years ago I was looking at doing a remodel on the shop but we were hamstrung by the structure of the building itself, which is 140 years old. Once we got that sorted out, I was a lot happier. We have a visibility now that we never had before. People can see into the store from across the road and the natural light is lovely. It’s a big change.” With the help of Careplus, Conefrey explains how he was able to bring the building up to an acceptable standard. He tells IPN that he is very satisfied with the decision to continue to become part of the Careplus network. The store is now bright, fresh and modern, and is a testament to Conefrey’s persistence and

Mark O'Flahe

Ling Lee, support Pharmacist, Marion Dempsey, front of shop Manager and Tomas Conefrey, Pharmacist and proprietor

brave decision-making, and to the assistance provided by the Careplus Support Office.

business, especially our front of shop which was always a challenge.”

“I’d been trying for a while to get something organised to address this issue and it was a massive job, I was finding it very difficult to get anything done. I wanted to modernise and give it an uplift but there was no point in doing a remodel when we had cracks down the walls and that kind of thing. Careplus assisted me where the building was concerned and I’ve had a very positive experience. It’s a big change, but it’s a good change. Previously if I wanted to find something out I’d have to go rooting around for it myself whereas now I get to bounce ideas off the Careplus business development manager. It takes a bit of getting used to but it’s starting to make my life easier. It is making a difference to the

Positive Outlook Conefrey is passionate about his job and enjoys his role serving the local community of Dublin city. His outlook is one of determined positivity, after a period of unsettling change. “I’m happy in the shop and I am happy doing this job at the moment. I try not to get too stressed about things anymore. Whatever comes down the line, we will handle it. Pharmacists went on strike in 2009 over the changes to the contract and that would have taken a lot out of me but things are getting better now. If someone was to ask me what I do I’d tell them I am a community pharmacist because I do my best to be part of the community. It is a very rewarding job. It’s not easy

either, the days can be long, but I love what I do. I think it’s a great job. Around the downturn it was hard but things are looking fairly good now.” Conefrey is active on social media and likes to keep up to date with issues and trends affecting pharmacists at all stages in their career and profession. “I have a pharmacy student here at the moment on placement and I was only telling her yesterday that it’s a great job. It’s opened up a lot in the last few years, there are lots of really positive opportunities available to young pharmacists now. Previously in my mind you had hospital pharmacy, community pharmacy, and industry but now after speaking with some students is seems that there are lots of branches off each of them that can be totally different. There’s a whole range of different

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Profile The old Conefrey’s Pharmacy shopfront

The modern Conefrey’s Careplus pharmacy shopfront

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placements available and lots of nice niche jobs out there now as [the profession] has segmented into smaller ones so there are lots of opportunities for young newly qualified students.”

to click. You just have to keep repeating the message year on year and eventually it will become ingrained in people’s minds.”

Conefrey retains an enthusiasm for serving the public that compliments his many years of experience and still gets excited about the pharmacist’s role in making people’s lives better. “From now until Christmas it will be full on with the flu vaccine and I love that part of [the job]. It’s so accessible, potentially on their lunch break people can come in here and get vaccinated against the flu and be on their way in fifteen minutes. It’s just another service we can offer to the local community and it takes a bit of pressure off the doctors. The GPs around here have a lot on their plate. Some years only a handful of people would come in for the vaccine and it was disappointing, but there about two years ago it seemed

Conefrey is realistic about the challenges faced on a daily basis and is tuned into the issues that pharmacists are watching for. IPN asked what the biggest challenges are, and how Conefrey’s addresses them. “There is a big challenge when your number one customer is the HSE and they are under pressure to get their budgets down so that is a major concern, but then again it’s always going to be there so I don’t know what the solution to that is. Providing extra services, such as emergency contraception, 24-hour blood pressure monitoring, and vaccinations can bring opportunities. Medicine shortages are also a big problem at the moment. I have about 20 things that I am looking for.”

Realistic

IPN asked how Conefrey’s Careplus gets around this perennial issue. “It depends really, there are options, for example I could try and get an unlicensed version of it but it’s more expensive. Even if they

Cailin (Con) Conefrey, who founded the pharmacy

are reimbursable on the scheme you only get a certain amount so you may have to buy something that’s more expensive than the reimbursable price, so there is a shortfall between the two that means you are out of pocket.“ Conefrey also demonstrates a willingness to keep progressing and evolving. IPN asked how the business is preparing for some of the important imminent changes that are on the horizon. “Medicine shortages, especially with Brexit, are one thing that I would be sort of worried about. Not worried exactly, it’s just something to be aware of. Over a period of time hopefully these things will start to resolve themselves. In my experience with medicine shortages they do come back or something happens where another manufacturer comes into the market and it is addressed, but I suppose Brexit has confused the whole issue now. As for the falsified medicines directive, at this stage now, it’s just another thing we will build into the day. That’s the way I look at it. I try not to get stressed about these things anymore. You just reach a point where you say, whatever comes down the line we will handle it.” By fusing the wealth of knowledge from an older generation with youthful, enthusiastic ambition, Conefrey’s Careplus pharmacy is in a great position and is fit to compete. The dynamism on display is wonderful to witness and Tomás Conefrey is a fantastic example of what is possible in community pharmacy when you stay up to date, try to get ahead of the curve, and most importantly, stay positive.


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DIORALYTE® NATURAL, BLACKCURRANT AND CITRUS, POWDER FOR ORAL SOLUTION PRODUCT INFORMATION Presentation: Sachet containing the active ingredients sodium chloride 0.47g, potassium chloride 0.30g, glucose 3.56g and disodium hydrogen citrate 0.53g. Indications: Oral correction of fluid and electrolyte loss and the management of watery diarrhoea in infants, children and adults. Dosage and administration: Each sachet should be reconstituted in 200ml (approximately 7 fluid ounces) of fresh drinking water. For infants where fresh drinking water is unavailable the water should be freshly boiled and cooled. The solution should be made up immediately before use. If refrigerated, the solution may be stored for up to 24 hours, otherwise any solution remaining an hour after reconstitution should be discarded. The solution must not be boiled after reconstitution. Daily intake may be based on a volume of 150ml/kg body weight for infants up to the age of 24 months and 20-40 ml/kg body weight for adults and children. A reasonable approximation is: Infants under 24 months – Use only under medical advice. One to one and a half times the usual 24 hour feed volume. Children over 24 months – One sachet after every loose motion. Adults (including elderly) – One or two sachets after every loose motion. More may be required initially to ensure early and full volume repletion. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and precautions: Dioralyte should not be used for treatment in infants below the age of 24 months without medical supervision. Dioralyte should not be used for self-treatment by patients with: chronic or persistent diarrhoea, liver or kidney disease, diabetes, on low potassium or sodium diets, intestinal obstruction. The use of Dioralyte in

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patients with these conditions should be supervised by a doctor. The solution must not be reconstituted except with water at the volume stated. A weaker solution than recommended will not contain the optimal glucose and electrolyte concentration and a stronger solution than recommended may give rise to electrolyte imbalance. If there is no improvement within 24-36 hours, consult the physician. If nausea and vomiting are present with the diarrhoea, small but frequent amounts of dioralyte should be drunk at first. No specific precautions are necessary in the elderly. However, caution is required in cases of severe renal or hepatic impairment or other conditions where the normal electrolyte balance may be disturbed. Pregnancy and lactation: Medical supervision is recommended for use during pregnancy and lactation. Interactions and side effects: None stated. Pack sizes: 6 and 20 sachets. Legal category: P. Product authorisation number: PA 540/98/1 (Blackcurrant), PA 540/98/2 (Citrus), PA 540/99/1 (Natural). Product authorisation holder: Sanofi, Citywest Business Campus, Dublin 24, Ireland. Tel 01403 5600, email: IEmedinfo@sanofi.com. For further information please see Summary of Product Characteristics. Date of revision: August 2018. Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Sanofi on 01403 5600 or email IEPharmacovigilance@Sanofi.com Date of Preparation: September 2018 SAIE.DIO.17.01.0010c(1)


News Pharmaceutical Assistants respond to PSI Council decision to redefine ‘temporary absence’ rules Members of the Pharmaceutical Assistants Association (PAA) from across the country took part in a planned walk-out from the public gallery after the PSI Council decided in September to adopt a new set of rules relating to the temporary absence of a pharmacist. Irish Pharmacy News reached out to PAA members for reaction. Deirdre Lynch is the secretary and media spokesperson for the group. She has been qualified to dispense medication for 40 years. The decision means that Lynch and her colleagues will no longer be permitted to dispense medication, save for one hour per day, to facilitate a lunch break for the pharmacist. “We are all very emotional,” Lynch told IPN. The members say that their qualification has been downgraded as a result of the decision, leaving pharmaceutical assistants and the pharmacists who wish to continue employing them in their current capacity in a difficult and upsetting position. PAA claim that redundancies and rural pharmacy closures will likely follow as a result of this move. Pauline Kavanagh is a pharmaceutical assistant from Dublin. “We’ve spoken to politicians, doctors, and pharmacists and nobody, except the PSI and the Council, can see the justification for what they are doing. We have met with the Minister for Health several times

and even he seems puzzled by it. Nobody can figure out why. “This time last year they gave us a licence to [practice]. If they don’t believe we are accountable that is for them to address. We have no problem being accountable or being subject to CPD and fitness to practice inquiries.” Historically, PAs would have covered pharmacists’ days off and often worked weekends. A report from the PSI working group on temporary absence claims that the agreement between PAA and the PSI (in its earlier format) “which was a mechanism of stipulating an agreed position or understanding of what constituted temporary absence” was not always adhered to. As a result, “legal certainty along with clear accountability pathways did not prevail.” PSI claim that PAs are not accountable as they are not subject to CPD requirements, nor can they be brought in front of a fitness to practice inquiry. PAA members say they are happy to be subject to both CPD and fitness to practice.

Dr Marita O’Brien produced a Human Right and Equality Impact Assessment of the proposed draft rules. An excerpt presents the results of a survey they carried out on 160 pharmacists. “Pharmacist respondents working with pharmaceutical assistants on a day to day basis, observing their practice, over many years, view pharmaceutical assistants to be as competent as they are, as evident in their assessment of pharmaceutical assistants under the PSI Competency Framework. Under S.I. No 488, pharmacy owners and superintendent pharmacists are acknowledged experts of the knowledge and skills their staff should have. The evidence from this research is that they are satisfied that the pharmaceutical assistants they employ to act in their absence, practice in professional, safe and ethical ways as observed by [...] pharmacist respondents.” Some PAA members expressed the view that the information supplied to Council members did not adequately reflect their level of expertise, given that the NARIC report (which was drawn

up to assess their accreditation) did not take account of the years of experience built up since the workers were awarded their qualification, equating it to Leaving Certificate level, a point that the workers question fundamentally. One PAA member told IPN that when the nursing qualification changed, nurses with an historical qualification were still permitted to practice. The PAA want to know why they were they not afforded a similar arrangement that would have allowed the workers affected to be naturally allowed to retire, especially given that all 248 people affected (98% of whom are women) are all over the age of 55. One woman told IPN that she has been working for the same pharmacist for 17 years. “The pharmacists we work for employ us because they know we have expertise. They know we are experienced. The pharmacist I work for would prefer to have me on than a locum because I know the customers. I know what medications they had last week, I know what age they are, I know their history.”

Irish people part of clinical trial to investigate anti-cancer properties of aspirin A new initiative, which is funded by the Health Research Board and the Irish Cancer Society, will see 300 volunteers from Ireland take part in a trial to investigate whether aspirin can prevent early-stage cancer from returning. Coordinated by Cancer Trials Ireland and facilitated in hospitals around the country, the “Add-Aspirin” trial involves 11,000 people from Ireland, India and the UK. Participants will self-administer aspirin daily over a period of five years and will be checked again ten years after treatment. Chief Irish investigator in the trial, Dr Gregory Leonard of University Hospital Galway, said a growing body of evidence, collected over 10 years, suggests that aspirin has potential as an anti-cancer agent. “At a time when we are used to new cancer treatments being

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relatively costly, the possibility of repurposing an inexpensive, generic drug that is available worldwide to stop or slow cancer is potentially ground-breaking,” said Dr Leonard. “The results of this trial could have a huge impact on the global cancer burden, particularly given the increasing cancer incidence in lower resource countries.” The trial is a phase III, double-blind, placebo-controlled, randomised trial with three groups. As it is not known yet how much aspirin is needed to have an effect, if any, two groups will receive a different dose of aspirin and the third group will receive a placebo.

Dr Gregory Leonard, Emma Corcoran, and Prof Bryan Hennessy at the launch of Add Aspirin trial


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Feature Pharmacists should encourage patients to talk openly about the changes associated with menopause Menopause, the end of regular menstruation, is a significant time for women and everyone will have a different experience. As society becomes more comfortable with female reproductive health and well-being, menopause is increasingly discussed in the open, more so than it was in the past. With rising life expectancy rates, women in most parts of the developed world can live up to a third of their lives in the post-menopausal state. supplements to patients who believe their dietary intake is inadequate, and can also offer cholesterol checks and bone density tests and advice on achieving an ideal weight. Catherine O’Keeffe, also known as The Wellness Warrior (www. wellnesswarrior.ie) specialises in perimenopause. O’Keeffe tells IPN what women can expect from a drop in hormone levels. Anxiety, for example, a lesser known but often distressing aspect of menopause, results from the loss of oestrogen’s calming effect on the system.

Aisling Grimley

The most widely reported symptoms are hot flushes and night sweats, known as vasomotor symptoms, but anxiety, low mood, vaginal dryness and loss of libido are often real sources of distress for women. Successfully managing menopause and perimenopause will mean a trip to GP for an increasing number of women and hormone replacement therapy (HRT) is an important option in symptom relief. For women with milder symptoms, lifestyle management can yield very positive results and drug-free options to help manage symptoms are available. Aisling Grimley’s website, mysecondspring.ie, takes the approach that while it can be challenging, perimenopause and menopause "is a completely normal life-stage, and not a disease to be treated.” Grimley tells Irish Pharmacy News that there is not enough information out there for those who are going through the change. “When I set up My Second Spring five years ago, it was in response to dearth of good solid menopause information online. Thankfully that has changed.” Grimley’s site is visited by women all over the world who are seeking proactive solutions to their menopause symptoms. “We wanted to both provide effective advice on symptom management, but also to reframe the ideas around menopause," she explains. “In China the menopause

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is known as the Second Spring and it is regarded as a time when women often find a new and more confident voice. Women at midlife are valued for their wisdom and respected for their life experience and so menopause is something of a badge of honour.” Through the course of her own journey and research, Grimley found nutrition and exercise to be the most helpful in managing symptoms and also praises the benefits of taking omega supplements from perimenopause right through to post-menopause. “Many of the symptoms are in fact indicative of decades of nutrient deficiencies catching up with us. If you don't eat (non fried) oily fish three times a week you are likely to be low in omega-3. Plant fat such as sunflower spread with omega-6 can help some women with hot flushes and in the maintenance of healthy hair and skin. Dairy products containing omega-7 can help with skin dryness and vaginal dryness during perimenopause.” Pharmacists can also provide supports to women during menopause, Grimley suggests. They can recommend nutritional

“Hot flushes, night sweats, insomnia, increased migraines, low libido and memory loss often give rise to health anxiety as women try to figure out if they are going crazy or merely growing old fast. And very often women have not made the connection that hormonal shifts are triggering anxiety. Once they realise that, the response is initially relief. Then they can take back some kind of control over their anxiety and moods. If women are slightly prone to anxious thinking before their fourties, this can really escalate with the arrival of perimenopause. We have seen this first hand over the last few years: many competent, levelheaded women become really blindsided by menopause’s anxiety acceleration. The fluctuation in oestrogen and progesterone in the menopausal years has been known to cause anxiety and depression.” Grimley and O’Keeffe have partnered together in their shared quest to help mainstream the conversation on menopause and how it affects women. They both believe that Irish society has adopted an ‘ostrich approach’ to the topic. “It’s like mental health,” says O’Keeffe. “It has taken people a long time to start talking openly

Catherine O'Keeffe

about [menopause] and there is still a way to go. While [it] is certainly talked about more than it was in my mum’s generation, the symptoms can feel deeply personal to most women. I find that many don’t even talk to their best friends about symptoms and also find it hard to discuss it with their partners.” Opening up to the realities of menopause can help to improve options for patients. Improving understanding and education on the topic could mean women will be more inclined to approach their health care providers to ask for help with solutions. Pharmacists should be poised to assist those in their communities who are in need of therapeutic intervention for the treatment of menopause. Having information and helpful products to hand will help towards dispelling unhelpful taboos and will reassure patients that not only do you understand, but that you are also ready to help.

Menopause is a completely normal life-stage, and not a disease to be treated


Feature Examining the positive role community pharmacy can play in helping the older generation As a population, Ireland is getting older. The most recent census statistics (2016) unequivocally lays bare that we have an ageing population, one which is expected to heap increased demand on the already struggling Irish health service. The report used population data from the 2016 census and statistics from the previous year regarding use of a range of healthcare services, including public and private hospital inpatient care, emergency department use, GP services, long-term and intermediate care such as nursing home care, and at home care. It highlighted that the demand for home help and places in nursing homes is forecast to increase by up to 54%, while the demand for GP visits is projected to increase by up to a quarter.

Dr Maeve-Ann Wren, author of a report into the impact an ageing population will have on healthcare

The Central Statistics Office 'Census 2016' report showed that the group aged 65 and over grew by almost one-fifth, 19.1%, between 2011 and 2016, making it the fastest-growing sector. The number of centenarians increased by more than onesixth (17.2%), and stood at 456. The data showed that the population has been getting steadily older since the 1980s. In the 2016 census, 37.2% were aged 45 and over, an increase of 2.8% since 2011 and of 9.6% since 1986. Over half a million, or 577,171, in the 65+ age group lived in private households, an increase of 19.6% since 2011. The number of people in the same group who were in nursing homes increased by 1,960 to 22,762. The largest increases in persons aged 65 and over were concentrated in Fingal (36.1%), South Dublin (34.1%), Kildare (32.2%) and Meath (27.4%). The smallest increases were in Dublin City with the population aged 65 years+ increasing by just 8.8% and Cork City (9.9%). Overall the number of males aged 65+ and living alone increased by 21.1% from 48,840 in 2011 to 59,163 in 2016, whereas the number of females increased by 11.6% over the same period.

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The number of long term residents aged 65 years and older enumerated in nursing homes rose by 9.4% to 22,762 persons in 2016. Expand significantly Fast forward two years and the landscape hasn't changed. Ireland is still getting older. But what does this mean in actual terms for the Irish health service? And what does it mean for the role of the community pharmacist in assisting elderly patients? An Economic and Social Research Institute (ESRI) report released last year found that the health service will have to expand significantly to meet the requirements of an ageing population. The population is projected to grow by up to 23%, or one million people, by 2030. This growth in overall numbers, combined with a projected increase of up to 94% in the number of people aged 80 or over, will have significant implications for the health service, according to the report, Projections of Demand for Healthcare in Ireland, 2015-2030. The ESRI have stated that this will have major implications for capacity and staffing in the health service.

The report has warned that if services do not increase to meet demand, there will be even greater pressure on other sectors of the public health service. "This research shows that expansion will be required in most forms of care to meet the needs of a rapidly growing and ageing population," said the report's lead author Dr Maeve-Ann Wren. According to the report, demand across all health and social care sectors will "increase substantially" year-on-year up to 2030. It notes that between 1996 and 2016, Ireland's population bucked the trend elsewhere in the EU, growing by 31% as opposed to just 6% across the union. The number of people aged 65 and over is expected to increase by 60-64% and the number aged 80 and over is expected to rise by 89- 94%, while the report projects this will result in a 32-37% increase in demand for inpatient bed days in public hospitals. Nursing home demand will rise by up to 54% (equivalent to up to 15,600 extra places in 2030). Home help hours demand will also rise by up to 54%, and demand for home care will rise by up to 66%.

Demand for GP services are also projected to increase markedly. Visits will rise by up to 27% with up to 27.4 million extra prescription items being issued in 2030. Pharmacists' role An interesting recent study, Optimizing pharmacotherapy in elderly patients: the role of pharmacists, examined the important role community pharmacists could play in providing primary care for elderly patients. The research found that the traditional tasks of medication dispensing and provision of basic education by pharmacists have evolved to active engagement in direct patient care and collaborative team-based care. "The care of older patients is an especially fitting mission for pharmacists, since the key to geriatric care often lies with management of chronic diseases and polypharmacy use, and preventing harmful consequences of both," it read. The study added that because most chronic conditions are treated with medications, pharmacists, with their extensive training in pharmacotherapy and pharmacokinetics, are in a unique and critical position in the management of them. "Pharmacists have the expertise to detect, resolve, and prevent medication errors and drugrelated problems, such as over treatment, under treatment, adverse drug events, and nonadherence. Pharmacists are also competent in critically reviewing and applying clinical guidelines to the care of individual patients, and in some instances confront the lack of data (common in older adults) to provide the best possible patient-centered care." Hickey's Pharmacies work with organisations across Ireland


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Feature "It is important to us that we can offer them the same level of service as every other member of the community," he said. "We offer each resident the chance to talk to our experienced pharmacists regularly and provide the homes themselves with the assistance they need to provide the best level of care possible. We regularly run training sessions for the staff on topics such as principles of medication management, medication in the elderly, constipation management and pain management. We work with each home individually on policy development and improvement, audit and review, and medication management systems."

Dan Spencer, Supervising Pharmacist at Hickey's in Gorey, Co. Wexford,

Dan added that increasing age and chronic disease are both associated with an increased reliance on health services and the traditional role of pharmacy has been changing to adapt to the increased burden felt by the sector.

from small assisted living homes for older persons with enduring mental illness to nursing homes with more than a hundred longterm residents. Dan Spencer, Supervising Pharmacist at Hickey's in Gorey, Co. Wexford, revealed to Irish Pharmacy News that care homes are "an important and growing part" of its business.

"The value of providing additional services is well demonstrated when you consider the impact of pharmacists providing seasonal influenza vaccinations. The practise of multidisciplinary reviews for residents in care home settings is strongly endorsed by HIQA and the PSI and provide excellent opportunity for pharmacists to contribute more to treatment optimization. Further developing and expanding services such as

these will benefit both patients and the healthcare system. "Community pharmacists are certainly in a unique position; having expert knowledge in pharmacotherapy and regular contact with our patients means we are in the perfect position to prevent, detect and resolve issues with medicines. Spotting issues such as overtreatment or undertreatment, poor understanding, adverse effects and non-adherence allows them to be addressed as they occur." Building relationships For elderly patients, developing a relationship with a pharmacist and using one pharmacy can help ensure consistency in care. A pharmacist can help prevent drug-related problems, which are a particular risk for the elderly. For elderly patients, pharmacists are sometimes the most accessible health care practitioner. In addition to dispensing drugs, pharmacists provide drug information to patients and providers, and monitor drug use (including adherence). They liaise with physicians or other health care practitioners and patients to ensure optimal pharmaceutical care. Pharmacists also provide information regarding interactions between drugs and other substances, including OTC drugs, dietary supplements (eg, medicinal herbs), and foods.

Pharmacists can help improve patient adherence by doing the following: • Assessing the patient’s ability to adhere to a drug regimen by noticing certain impairments (eg, poor dexterity, lack of hand strength, cognitive impairment, loss of vision). • Teaching patients how to take certain drugs (eg, inhalers, transdermal patches, injectable drugs, eye or ear drops) or how to measure doses of liquid drugs. • Supplying drugs in ways that are accessible to patients (eg, easy-open bottles, pills without wrappers). • Making sure that drug labels and take-home printed materials are in large type and in the patient’s native language. • Teaching patients how to use drug calendar reminders, commercially available drug boxes, electronic drugdispensing devices, and pill splitters or crushers. • Eliminating unnecessary complexity and duplication from the overall drug regimen. • Completing a medication reconciliation when patients transition to and from various care settings.

News Ireland ranks in top 12 in global density of pharmacists Almost three quarters of the global pharmacy workforce will be women by 2030, predict the authors of a report who mapped industry trends over the past decade. The report from the International Pharmaceutical Federation, Pharmacy workforce intelligence: Global trends, analysed workforce data collected from 75 countries between 2006 and 2016. It shows the total number of pharmacists has increased since 2006, projects a further increase in the global pharmacy workforce of up to 40% by 2030. In Ireland, the "pharmacist density" the number of pharmacists per capita has risen over the past

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decade from 8.5 per 10,000 people to 11.8. This ranks Ireland in the top 12 countries for pharmacist density.

pharmacy workforce. The South East Asia region showed the highest proportional increase in female pharmacists.

According to the report, lowincome countries experienced the slowest growth and the industry faces a widening income-based capacity gap between countries.

The authors predict that, if current trends continue, there will be an overall global increase of almost 16% in female workforce participation by 2030, resulting in an estimated female workforce of 72%. The report suggests this should become a significant factor for workforce planning for many countries.

The study, published at the 78th World Congress of Pharmacy and Pharmaceutical Sciences, points to a steady increase in the proportion of women in the

“The increasing proportion of women in the workforce will have complex implications for health workforce planners which will include a hard look at gender equity issues in addition to a greater professional and economic focus on how we support ‘return to practice’ after career breaks,” said the report’s lead author, Professor Ian Bates. The report suggests there is a pressing need for further analysis of workforce intelligence in a bid to better understand regional trends.


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News Oireachtas Health Committee hears pre-legislative scrutiny of the Patient Safety Bill

news brief

The Oireachtas Health Committee has begun its examination of the Patient Safety Bill, which will provide for mandatory open disclosure of serious reportable events. Registered pharmacists will fall under the scope of the legislation and will be subject to its provisions if the Bill is passed into law by Dáil Éireann.

UPDATE ON THE GLOBAL EPIPEN SHORTAGE A shortage of Epipen is causing problems for parents of children with life-threatening allergies, it has been reported.

Minister for Health Simon Harris TD welcomed the pre-legislative stage, saying: “This landmark law will apply both to individual health practitioners as well as organisations providing healthcare. This Bill will be a significant milestone in embedding a culture of change within the Irish health service." The Committee heard submissions in late September from the Department of Health and Chief Medical Officer Tony Holohan said at the time that patients have a primary right to “full knowledge about their healthcare, as and when they wish". This follows publication of the Scoping Inquiry into the CervicalCheck Screening Programme report, wherein Dr Gabriel Scally criticised the current requirements regarding open disclosure. The foreword says: “The current policy and practice in relation to open disclosure is deeply contradictory and unsatisfactory. In essence,

Irish Pharmacy News requested an update from the HPRA on the situation in the Republic and how it is affecting patients here.

Tony Holohan, Chief Medical Officer, Department of Health there is no compelling requirement on clinicians to disclose. It is left up to their personal and professional judgement.” The Patient Safety Bill, which was in development prior to the publication of Dr Scally’s report, will, according to Holohan, provide the legislative underpinning for mandatory open disclosure. The proposed legislation however has raised concerns, with patient

advocates and medical experts urging a re-think of the provisions that would criminalise medical practitioners who fail to disclose information in relation to serious events. Simon Mills, who is a barrister and former doctor, is reported to have told a conference hosted by the State Claims Agency that there was a “rush to criminalise” medics and that “politicians need to be seen to be doing something.”

Depression the biggest health concern for Irish people Irish people more worried about depression and anxiety than any other illnesses, according to research by NUI Galway. Researchers from the J.E. Cairnes School of Business and Economics surveyed more than 1100 adults on their relative preferences for different states of health ranging from perfect health to being dead. These ratings were then broken down into five domains: mobility, self-care, usual activities, pain/ discomfort and anxiety/depression. Each domain was broken down by a level of severity ranging from “no problem” to “extreme problems.”

importance to anxiety/depression than do people in other countries where similar studies have been undertaken.

it allows researchers in Ireland to generate quality adjusted life year measures based on Irish preferences.

According to the paper, Irish people attach a higher value to anxiety/depression and pain/ discomfort than people in England and Germany.

“Quality adjusted life year measures are an integral part of health technology assessments, a method used to assess the relative value for money of alternative uses of healthcare resources, such as those produced by the Health Information and Quality Authority or used by the National Centre for Pharmacoeconomics in Ireland.”

The greatest weight was placed on anxiety/depression, followed by pain/discomfort.

Professor Ciaran O’Neill, NUI adjunct professor and lead author of the research, said the study provided valuable insights into health preferences and allowed for meaningful comparisons of preferences in Ireland with those in other countries.

The findings, published in PharmacoEconomics, show that not only do people in Ireland attach greater importance to anxiety/depression as a dimension of health, but they attach more

“The study used an internationally recognised descriptive system and an internationally validated protocol to measure the relative importance attached to different health states in Ireland. Importantly

The research, conducted over two years, was undertaken in collaboration with the EuroQol Research Foundation in the Netherlands, the Office of Health Economics in London, and the Centre for Public Health in Queens University Belfast.

The HPRA said: “The global supply of EpiPen continues to be intermittent due to manufacturing constraints. In relation to the current situation for patients in Ireland, the HPRA is aware that additional stock of EpiPen was made available this week. “Furthermore, the HPRA is aware that there are alternative adrenaline auto-injectors (AAIs) available. The HPRA is actively working with all companies who market AAIs in Ireland to maintain supplies of those medicines and minimise any impact on patients and healthcare professionals.” A further advisory update from the HPRA tells pharmacists that “there is intermittent supply of adrenaline auto-injectors (AAIs) affecting the Irish market. The availability of specific brands of AAIs may change.” The Financial Times recently reported on the reasons behind the global shortage. “Although Mylan owns the rights to the EpiPen, which can stave off deadly anaphylactic shock, it subcontracts manufacturing of the auto-injector to Meridian Medical, a division of Pfizer … Mylan has responded to the shortage by sending a team of its own managers to try to fix problems at a Pfizer factory in St Louis, Missouri.

MAN JAILED FOR STABBING PHARMACISTS A man has been jailed for six years after stabbing two Belfast pharmacists while trying to steal tramadol. Patrick Campbell, 28, attacked the staff at McDonagh's pharmacy in April last year after being denied tramadol. Neither of the pharmacists suffered life-threatening injuries. As part of his sentence, Campbell will also serve six years on supervised licence after his release from jail.

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Pharmacy Management Programme

New interactive pharmacy management programme launched Retail Excellence, Ireland’s largest retail industry body, recently launched their new, educational and interactive Pharmacy Management Programme. The objective of the programme is to inspire pharmacy owners/managers to operate the best performing and most profitable pharmacy business.

David Fitzsimons, Group CEO of Retail Excellence

time and also how to prioritise the most important tasks for their role and the business.” The programme will then work through all the key areas including how to improve financial performance, critical work place policies, digital marketing strategy and the role of the manager.’

Cormac Tobin, former MD Celesio

Drive Your Pharmacy to the Next Level The programme will be facilitated by Patrick McCormack (former MD/CEO of the Sam McCauley Group) who will also deliver a variety of workshops throughout the programme. The two intensive days will cover key topics relevant to all pharmacy managers/owners and delegates will return to the business with the knowledge to elevate performance, finances and the team to a much higher level.

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Speaking recently to Irish Pharmacy News, Helen O’Dowd, Head of Learning & Events at Retail Excellence told us about the programme: “We believe that this programme can steer the leaders in the Irish pharmacy sector to increase OTC sales and overall store and team performance. “To achieve this, the two day programme will start at the top of the ladder with the pharmacy owner/manager themselves with an intensive time management session to help them maximise the effectiveness of their own

One of the key workshops will be delivered by Patrick McCormack – ‘key financial matters for the pharmacy manager’ which will cover topics such as o The ultimate pharmacy store P&L o Key costs to monitor in your business (wages, marketing etc) o Improving your gross margin o Better purchasing in your business o Turnover and how to track it o Commercial awareness

o Space allocation and productivity o Creating an effective business plan and strategy o How to track your business performance O'Dowd went on to explain “the importance of generating sales from social media marketing is an area which some pharmacies shy away from and so the programme will include a workshop by Conor Cochrane, founder of Social Media Elite which will cover the clever use of digital/online marketing, website presence and how to make bloggers work for you”. Critical HR workplace policies will be covered in depth by Tom Smyth & Associates. The workshop will cover topics such as recruiting skills, critical contract/handbook procedures, discipline and grievance, common pharmacy HR issues (and solutions) and performance appraisals. A vital part of the two day programme is networking and dinner on Monday evening will


Deirdre Devaney, Global Head of Beauty at Aer Rianta International

Susannah Hewson owner of CX Change

Each workshop over the two days will build the confidence and effectiveness of the pharmacy owner/manager to ensure success.

industry players are adapting their businesses to these changes.’

afford delegates this opportunity while also hearing Cormac Tobin, former MD Celesio UK & Ireland ‘Release the Genius’ in his after-dinner speech. Day two will open with Susannah Hewson, owner of CX Change, focusing on improving the customer experience (CX). The customer experience is not all about customer service and hewson will delve into the six key drivers of customer experience excellence and how each can be applied in your business. Patrick McCormack will review ‘Your Role as the Manager’ and cover issues such as motivating your team, staff retention, dealing with poor performance and the top five tips to improve your management skills.

David Fitzsimons, Group CEO Retail Excellence, will present an enlightening presentation on what the pharmacy manager should consider to future proof the business in a workshop titled ‘Rethinking Pharmacy.’ Fitzsimons will explore what you must consider to future proof in your pharmacy, including how to be an authority on key product categories, being open about your heritage and beliefs, and how to captivate customers through difference. A crucial area in all pharmacies is the sale and knowledge of beauty products. Deirdre Devaney, Global Head of Beauty at Aer Rianta International, will explore the global tectonic change that is now taking place in the beauty industry, what are the key changes and how key

Helen O’Dowd said: “We have found over the years at other programmes which we deliver, that delegates learn so much by sharing information and so this programme will be fully interactive. Each workshop over the two days will build the confidence and effectiveness of the pharmacy owner/manager to ensure the success and future proofing of both themselves personally and their business.” For full information on this programme which will be held on Monday 15th October and Tuesday 16th October at the Crowne Plaza Hotel Blanchardstown, contact Helen@retailexcellence.ie or phone 065 6846 927.

Patrick McCormack, former MD of the Sam McCauley Group, who will facilitate the programme

The programme will work through all the key areas including how to improve financial performance, critical work place policies and digital marketing strategy. 23


ePharmacy

Local pharmacies to embrace e-commerce and digital transformation IE Domain Registry, the company that manages and maintains Ireland’s country domain name, .ie, has partnered with Retail Excellence, to assist pharmacies across the country to develop their digital skills and improve their web presence and e-commerce capabilities. Through the partnership, ten Retail Excellence pharmacy members will participate in the 2018 IE Domain Registry OPTIMISE Programme. Each participant of the programme will receive an extensive sector-specific, digital health check from expert digital consultants along with a list of tailored recommendations, which will help each pharmacy improve their online presence, hone their digital skills, and develop their e-commerce capabilities. A follow up review will also assist in monitoring improvements made and future progress. Participants in the OPTIMISE Programme will be given fast-track access to the LEO Trading Online Voucher Scheme which provides much needed financial assistance to implement potential improvements. The value of e-commerce "E-commerce is worth ¤12.3 billion to the Irish economy, but according to figures from the latest IE Domain Registry Digital Health Index (Q4 2017), only 14% of Irish SMEs have web sales ability. Almost 20% of Irish SMEs have no online presence whatsoever.. The pharmacy sector in particular has a lot to gain from e-commerce. According to Retail Excellence research, the sector has enjoyed continuous growth over the past 24 months, and has been the highest performing sector online. During Cyber Week 2017, some pharmacies reported YOY sales growth of up to 60%, indicating increased demand for products and services bought online. A modern, e-commerce-enabled web presence will help pharmacies communicate with and sell to their existing customers, reach out to new ones and create new revenue streams. A new approach to OPTIMISE Now in its eighth year, the IE Domain Registry OPTIMISE Programme has helped over 130 small and micro-business owners to build and improve their website, connect with new and existing

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customers, and sell products and services in Ireland and across the world. Last year, IE Domain Registry relaunched the OPTIMISE Programme with a focus on closer partnerships with industry sector and representative organisations, who are already trusted and highly valued by their members. In changing the approach, the OPTIMISE Programme has been able to scale up to help more SMEs become digitally enabled more quickly. The company has invested ¤742,000 in the programme to date. Commenting on the partnership, David Curtin, Chief Executive of IE Domain Registry, said: “IE Domain Registry is delighted to partner with Retail Excellence to assist them in helping their pharmacy members grow their online presence and improve their e-commerce capabilities. “A modern web presence helps businesses drive revenue growth, connect with and learn from customers, and stay competitive. It also helps to defend against external challenges. While larger retail chains may be able to absorb some of the costs, smaller, independent retailers will need to use every method available to keep their customers loyal and informed, keep revenue streams open, and expand in new markets. “Our OPTIMISE Programme has a proven track record of helping micro-businesses and SMEs to re-set their digital priorities and address their individual challenges and barriers. We take a handson approach, working closely with business owners to develop personalised digitisation plans that get them online, engaging with customers online, and selling their products and services via the web. “Considering the huge value of e-commerce to the Irish economy, we believe it is in the interest not just of SMEs but industry sector bodies and representative organisations to promote the benefits of an online presence. We look forward to working towards

Pictured are David Curtin, CEO IE Domain Registry and Lorraine Higgins, CEO Retail Excellence. IE Domain Registry has partnered with Retail Excellence, the largest retail industry representative body in the country, to assist pharmacies across Ireland to develop their digital skills and improve their web presence and e-commerce capabilities

this goal with Retail Excellence and our other industry partners.” Lorraine Higgins, CEO of Retail Excellence, said: “We are delighted to partner with IE Domain Registry which will enable us to empower and assist our member retailers in embracing the opportunities that online presents. “It is important for retailers to have a digital and omnichannel offering as it makes it easier to grow their sales and reach out to existing and potential customers. With the increasingly boundaryless nature of the industry and consumer shopping habits evolving, it is important

that retailers are on the curve. Through our partnership with IE Domain Registry we will assist the pharmacy sector in increasing its online presence which will enable it to take advantage of some of the ¤21 million being spent by Irish consumers online every day.” The first five pharmacy participants in the 2018 IE Domain Registry OPTIMISE Programme are: D Pharmacy, Ardee, Co Louth; Mellerick’s Pharmacy, Fermoy, Co Cork; Phelans Pharmacy, Cork, Co Cork; The Family Pharmacy, Tullow, Co Carlow; and McFadden’s Pharmacy, Stoneybatter, Dublin 7.


Feature

Pharmacies can play an active role in family planning For most couples, starting or adding to their family is a straightforward enough experience, but for many others who have difficulty conceiving straight away, there are lots of steps that can be taken before seeking help through tests or other medical supports. Pharmacies are available, sometimes up to seven days a week, to offer free, professional advice to couples who want to conceive. Improving your pharmacy’s offering in terms of the supports available to couples can bring opportunities for your business. This is especially the case if you operate in an urban area with a demographic profile that includes a lot of young families. Women are most fertile in their mid–twenties and some can have babies well into their forties, however the chances decrease significantly with each passing year beyond the age of 35. Sperm levels in men are strongest around their midtwenties and start to decrease after the age of 40. Laura Dowling is a pharmacist in Dublin. Also known online as the Fabulous Pharmacist, Dowling has some advice for couples who want to have a baby. “You want your body to be in the best possible condition ready for conception so it’s advisable to start preparations by both you and your partner taking a comprehensive conception multivitamin a few months before you start trying, to help correct any nutritional deficiencies. It can be difficult to get all the nutrients you need from your diet in today’s busy world. This is especially important in the case of Folic Acid, which should be supplemented at least three months before a woman becomes pregnant.” Supplements for before, during and after pregnancy are popular among consumers and can add value to your bottom line.

Some pregnancy tests are so sensitive that they can even indicate how many weeks along a pregnancy is 26

Customer Options There are many kinds of pregnancy and conception tests available and often women will know which particular type or brand they are looking for when they walk into your pharmacy. From ovulation tests to conception kits to digital pregnancy tests and phone apps, there are lots of devices and products out there that pharmacists can recommend to couples trying to conceive. Some pregnancy tests are so sensitive that they can even indicate how many weeks along a pregnancy is. Do some research around the most popular brands and try to give the customer options. Pharmacies should make sure to stock a wide variety of lubricants as some should be avoided by couples who want to conceive. Dowling explains why it is important to offer a number of options to consumers. “Many couples use lubricants as part of their sex lives and with people often having sex a lot more regularly when they are trying to conceive, you might be considering buying one. However, check the labels or better still ask your pharmacist for advice about the best brands to use as some contain spermicide which can hamper your efforts to get pregnant.” Women who use a contraceptive implant (inserted in the upper arm) can return to full fertility sometimes within hours of the device being removed. It can take slightly longer, sometimes months, to return to full fertility after an intrauterine device (IUD) has been removed. It’s best to stop taking the pill a few months before trying as it can take some months for menstruation to return to normal, however every woman is different and for many

Pharmacist Laura Dowling

women a normal menstruation cycle can resume immediately. Dowling explains why this helps when trying to conceive. “Medically there’s no risk in trying straight away, it just helps to date your pregnancy once you conceive. Many women also find it really helpful to track their periods for a few months so they can build up a good picture of their cycle length, which can make pinpointing when to have sex around your fertile period a little easier.” Dowling also advises women to check with their pharmacist to ensure the medications they are currently taking are appropriate when trying for a family. "Your pharmacist will tell you if they're safe to continue taking, both while trying to conceive and in

early pregnancy, and whether you need to visit your GP to discuss maybe swapping unsuitable drugs for alternatives to ensure your medication does not interfere with attempts to conceive.” Dowling advises couples to adopt a healthy lifestyle, to eat a balanced diet and to try to build regular exercise into their routine. “This might sound odd but by following some of the lifestyle rules you’ll adopt once are pregnant - like cutting back on caffeine and alcohol - you’ll actually help your chances of getting pregnant. Eat well, sleep well and party a little less! This is important for men also as a healthier lifestyle will mean healthier sperm.”


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ICDRA Drug regulators from across the globe convene in Dublin: EU ‘fortunate’ to have fully integrated regulation - Minister Harris Describing it as a “significant event,” Minister for Health Simon Harris led the opening ceremony at the recent International Conference of Drug Regulatory Authorities 2018 (ICDRA). Welcoming over 500 delegates from more than 100 countries, Mr. Harris said he “looked forward to hearing about and acting upon the wider outcomes of the recommendations arising from the 2018 conference.” Recommendations from ICDRA conferences provide regulators and the WHO with a roadmap for developing future policy decisions. Hosted this year in Dublin by the HPRA in conjunction with the World Health Organisation (WHO), a wide range of policy areas were discussed under the theme: Smart Safety Surveillance. It was the largest single global gathering of medicines regulators and the biannual event is one of the most important dates in the drug regulatory calendar. "The role of the regulator in safeguarding public health has never been greater," Mr. Harris said. "The effects of a poor or mishandled regulatory system for medicines can be dangerous, as we have all unfortunately seen in the past." The event re-emphasised the responsibility of regulators to maintain constant vigilance - from product development to end use - and the problem of substandard and falsified products, which are a worldwide problem, featured prominently. Attendees also heard how regulators play a vital role in combating antimicrobial resistance and in helping to bring public health emergencies under control, such as during the recent Ebola crisis in sub-Saharan Africa. Health authorities in the Democratic Republic of Congo are still declaring new cases. Speakers also welcomed an emerging emphasis on the need to achieve greater regulation in the area of medical devices. Delegates heard how drug regulatory authorities around the world operate at various levels of expertise with differing enforcement abilities, but that under the umbrella of ICDRA their purpose is universal: to strengthen global collaboration and increase patient safety and access to health products in every corner of the world. Regulators were strongly encouraged to prioritise collaboration across borders to help to approve and register new

28

health products more rapidly, ensuring faster access for patients. Inequality of access to quality assured, life-saving medicines however is an intractable problem and regulators from low and middle-income countries were well-represented on the day. The conference heard that up to 42% of medicines in sub-Saharan Africa are falsified or substandard. "In Europe, we are fortunate in having a fully integrated regulatory system, which provides some level of certainty and predictability around the authorisation of medicines," Mr. Harris said. He also spoke about medicine shortages arising from production issues and commercial decisions, and flagged "unexpected" causes, such as the UK's decision to leave the European Union. Emer Cooke is the head of regulation of medicines and other health technologies at the WHO. Dr. Mariangela Simão, assistant director-general for access to medicines, vaccines and pharmaceuticals at WHO also addressed the conference. Formerly a quality assessor at the original Irish National Drugs Advisory Board, an organisation which predated both the Irish Medicines Board and the HPRA, Cooke told delegates that seeing ICDRA hosted in her hometown had “special significance” for her and that she hoped ICDRA Ireland 2018 would be a “safe space for regulators to speak freely about the issues that matter to them”. Cooke criticised health systems for taking too long to approve products, saying it is a sign of “weak regulation”. This comes at a time when the Irish media is reporting on the concerns of the Irish Pharmaceutical Healthcare Association (IPHA), who claim that

Guido Rasi, Executive Director of the European Medicines Agency Irish patients are among the last in Europe to get access to new medicines. IPN recently reported that the IPHA believes the approval process for new medicines in Ireland is “frustratingly slow” especially given that certain products manufactured here are exported for use in other European nations, yet are still not sanctioned for use here. The IPHA claim that Irish patients are missing out on access to new cancer, cardiovascular and musculoskeletal treatment. Cooke told delegates that “a good regulatory system gives people the confidence that the medical products they need and use are safe and will work as intended. Conversely, a weak regulatory

system undermines patient safety and access, for example, by taking too long to approve products.” Lorraine Nolan is the CEO of the Irish medicine’s regulator, the HPRA. Nolan explained how the Irish drug regulatory system has evolved. “The patients and the public we serve are changing hugely and that’s not just from the perspective of life expectancy but also in terms of the range and profile of chronic diseases. Patients are much more knowledgeable now than ever before and more empowered to take control of their own healthcare. They quite rightly want to understand how we make regulatory decisions and that requires us to have structures


particularly how it has grown to encompass a broader remit and a greater number of regulatory functions. We are responsible for regulating a wide range of health products and these include human and veterinary medicines, medical devices, blood components, human tissues and cells and organ transplantations and cosmetics. We regulate manufacturing, wholesale and distribution companies, medical device notified bodies, as well as other health product facilities. The scale of that expansion has been quite dramatic for us. In the past 10 years we have doubled our staffing, invested entirely in workflow and electronic processing technologies, expanded our expertise across all the scientific and clinical disciplines and developed our business support functions, including quality systems, legal, HR, all to support our growth.”

Emer Cooke, Head of regulation of medicines and other health technologies at the WHO

in place to be better able to give them that information, and that is the cornerstone of transparent regulation. “We are a small country but collaboration has had immensely positive benefits for us as an agency, but most important of all, for our patients. We actively participate in the European system for medicines and medical device regulation. We feed into it through information, data, and our people - who participate at the highest level. Our structure enables us to operate on a network basis with the EMA and that includes all of the agencies throughout the 28 EU member states and the EEA countries. We have developed strong bilateral relations with many of our regulatory partners across the globe and we are keen to develop further participation and contribute in capability building in low and middle-income countries. Put simply, we invest in collaboration and partnership to make the global system of regulation stronger. I also believe our own story as a regulatory agency is somewhat special, and

Guido Rasi is the Executive Director of the European Medicines Agency. He congratulated the WHO and the HPRA for delivering and putting together a programme of “this depth and this complexity.” Rasi lamented the European Medicines Agency’s plans to relocate from London to Amsterdam, due to the looming spectre of Brexit. “Despite this challenge, the EMA are committed to continuing where we can our engagement to support the WHO and to further our support to regulators and networks in resource-limited regions. The cornerstone of the success of the

Lorraine Nolan, CEO of the HPRA

EU’s regulatory model is strength through reliance. We know that no one single agency can do it all, no matter the size of its resources. We know this from our own experience and by working together we also learn from each other, taking the opportunity to further strengthen our network. We all face similar challenges, and so the need for cooperation between health bodies has never been greater than today.”

The last biannual ICDRA event was held in South Africa in 2016 and the opening ceremony famously ended in a celebration of traditional African music and dance. The 2018 event in Dublin did not disappoint in this respect and rather untypically for formal events like these, delegates ended the morning with an impromptu ceilí, prompting one organiser to joke, “this happens at all the conferences!”

HPRA's Lorraine Nolan, Minister for Health Simon Harris, and WHO Head of regulation of medicine Emer Cooke

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www.septanazal.ie

Xylometazoline hydrochloride/ Dexpanthenol

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Septanazal® nasal spray with dexpanthenol not only unblocks the nose, but also heals and protects dry and irritated nasal mucosa. + Acts within 5–10 minutes + Long-lasting ease of breathing + Contains no preservatives Septanazal: The nasal spray solution contains xylometazoline hydrochloride and dexpanthenol. Indicated for adults and children over the age of 6 for reducing swelling of the nasal mucosa in rhinitis and as supportive treatment for healing the mucous membrane lesions, for the relief in vasomotor rhinitis and for the treatment of nasal respiratory obstruction after nasal surgery. Adults and children over 6 years of age: The usual dose of Septanazal for adults and children aged 6 years or over is one spray into each nostril up to 3 times a day. Regarding the duration of treatment in children, a doctor should always be consulted. Precautions: This medicinal product may be used only after a careful assessment of the risks and benefits in cases of: patients being treated with the monoamine oxidase inhibitors (MAOIS) and other drugs which potentially increase blood pressure, increased intraocular pressure, especially narrow-angle glaucoma, serious heart and circulatory diseases (e.g., coronary heart disease, hypertension), phaeochromocytoma, metabolic disorders (e.g., hyperthyroidism), porphyria and prostate hyperplasia. In chronic rhinitis it may be used only under medical supervision owing to the danger of the atrophy of the nasal mucosa. The prolonged use and overdose of decongestant sympathomimetics in particular may lead to reactive hyperaemia of the nasal mucosa. This rebound effect causes narrowing of the airways and, consequently, the patient uses the medicinal product repeatedly until its use becomes permanent. The consequences are chronic swelling (rhinitis medicamentosa) or even atrophy of the nasal mucosa. In less severe cases consideration can be given to discontinuing the use of the sympathomimetic in one nostril initially and, after the symptoms have abated, changing to the other side in order to maintain at least part of the nasal respiration. Direct contact of the medicinal product with the eyes should be avoided. In case of misuse or use of excessive amounts of the spray, the absorption of xylometazoline can cause systemic adverse effects, particularly in children (cardiovascular and neurological adverse effects) (see sections 4.8 and 4.9). Concomitant use of the product with medicinal products for local or systemic treatment of the flu and sympathomimetics contained in cough-and-cold medicines (e.g.: pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) is not recommended in order to avoid an increased risk of possible cardiovascular and neurological adverse effects (see section 4.5). Contraindications: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the SPC, dry inflammation of the nasal mucosa, history of transsphenoidal hypophysectomy or other surgical interventions which expose dura mater. Septanazal for adults is contraindicated in children under 6 years of age. Fertility, pregnancy and lactation: Septanazal should not be used during pregnancy, as there is not sufficient data available concerning the use of xylometazoline hydrochloride by pregnant women. Septanazal should not be used during the lactation period, since it is not known whether xylometazoline hydrochloride is excreted in the breast milk. There is no data on the influence of Septanazal on fertility. Adverse reactions: Uncommon: hypersensitivity. Rare: palpitations, tachycardia, hypertension. Very rare: restlessness, insomnia, fatigue, headache, hallucinations, rebound congestion, nosebleed, convulsions. Not known: burning and dryness of nasal mucosa, sneezing. Shelf life: 2 years. Legal category: Medicinal product not subject to medical prescription. Marketing authorisation number: PA1347/058/002. Marketing authorisation holder: Krka, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia. http://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA1347-058-002_19012017142039.pdf Date of Preparation: October 2017. Additional information is available on request from Krka Pharma Dublin Ltd. Unit 4A, Leopardstown Business Centre, Ballyogan Road, Leopardstown, Dublin 18. D18 KX88. Reference number: 02-02-2018. * Passàli D, Salerni L, Passàli GC et al. Nasal decongestants in the treatment of chronic nasal obstruction: efficacy and safety of use. Expert Opinion on Drug Safety 2006; 5(6): 783–90.

1/2018, Ireland, 63-2018, RB/MB.

NEW


CPD 95: PARKINSON'S DISEASE Biography - Since becoming owner of Whelehans Pharmacy, Eamonn Brady MPSI has striven to build and grow his business around his philosophy of placing his customer led, independent pharmacy firmly at the centre of his community and to extend its reach through engagement “outside the front door” with the public and local groups. At the core of Eamonn’s vision of his own role as a community pharmacist, is his belief that prevention is better than cure and to “help people to help themselves” through education and information initiatives delivered in a variety of ways.

Reflection - Is this area relevant to my practice? What is your existing knowledge of the subject area? Can you identify any knowledge gaps in the topic area? Planning - Will this article satisfy those knowledge gaps or will more reading be required? What resources are available? 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. Evaluation - How will you put your learning into practice? Have I identified further learning needs?

60 second summary Parkinson's disease is a chronic disorder caused by degeneration of dopamine generating cells in the mid-section of the brain. The reason for this degeneration remains largely unknown. Parkinson’s usually develops in people over the age of 50 and is rare in people under 50. Parkinson’s does not seem to have a genetic link. Symptoms: The brain cells and nerves help produce smooth, co-ordinated movements of muscles. The gradual reduction of dopamine causes the three main symptoms of Parkinson’s: slowness of movement, stiffness and tremor. Treatment: While there is no cure for Parkinson’s, treatments ease symptoms and slow progression. Medication: General consensus recommends starting with a dopamine agonist (i.e. levodopa) with a dopa-decarboxylase inhibitor or a monoamine-oxidase inhibitor. Levodopa is considered most effective and is central to any pharmalogical treatment regime Dopamine agonists: Dopamine agonists mimic dopamine. Ropinirole (Requip®), pramipexole (Mirapexin®) and rotigotine (Neupro® patch) are used most commonly. Despite being slightly less effective than Levodopa, one potential advantage compared with levodopa is at least 50% lower risk of dyskinesia. Dopamine agonists may be prescribed first choice to delay starting levodopa as levodopa generally only works well for about five years. Mono-amine oxidase-B inhibitors: They include selegiline (Eldepryl®) and rasagiline (Azilect®). They work by inhibiting or blocking the effect of monoamine-oxidase-B (MAO-B) in the brain preventing the breakdown of levodopa and dopamine. Blocking MAO-B means the effect of dopamine lasts longer. Most Parkinson’s patients require levodopa eventually when the disease gets worse. Other medication used for Parkinson's disease: Catechol-O-methyltransferase (COMT) inhibitors have become available in the last 20 years. (eg) Entacapone (Comtess®) and also an ingredient in Stalevo®. COMT inhibitors may be prescribed in combination to levodopa.

Parkinson's Disease Parkinson's disease is a chronic (long-term) disorder of caused by the degeneration of dopamine generating cells in the mid-section of the brain. The reason for this degeneration in Parkinson’s patients remains largely unknown. It mainly affects the way the brain co-ordinates movements of the muscles in various parts of the body. Symptoms gradually worsen over time. The main symptoms of Parkinson's disease are stiffness, shaking (tremor) and slowing of movement. There is no cure, but treatment can slow down its progression and can provide good relief of symptoms for several years in most patients. Modern treatment options mean that people with Parkinson’s can have a normal or near normal life expectancy. Profile of patients According to the Parkinson’s Association of Ireland, approximately 9000 people in Ireland are affected by Parkinson’s. Parkinson’s usually develops in people over the age of 50 and is rare in people under 50. It affects about 5 in 1,000 people in their 60s about 40 in 1,000 people over 80.1 Men are one and a half times more likely to get Parkinson’s than women.2; the reason for this is unknown. Parkinson’s does not seem to have a genetic link, so it does not appear to run in families. There is some evidence that there is a small risk of a hereditary link in those who develop it under 50. There is some evidence that smoking increases risk of Parkinson’s.3 Causes The substantia nigra region of the brain is the area affected. The substantia nigra controls muscles in the body by sending messages via nerves in the spinal cord to the rest of the body. Messages are passed between brain cells, nerves and muscles via chemicals called neurotransmitters. Dopamine is the main neurotransmitter produced by the brain cells in the substantia nigra. With Parkinson’s, cells

in the substantia nigra become damaged and die over time. As the cells die, the amount of dopamine produced is gradually reduced. Symptoms The brain cells and nerves normally help to produce smooth, co-ordinated movements of muscles. The gradual reduction of dopamine causes the three main symptoms of Parkinson’s, slowness of movement, stiffness and tremor. The symptoms of Parkinson’s often occur in one side initially (eg) tremor in one leg or one hand, loss of ability to swing your arm or leg on one side.3 It is worth noting that a reduced sense of smell may be one of the initial symptoms in early Parkinson’s.4 Slowness of movement (bradykinesia). This causes difficulty performing simple everyday activities like walking, climbing stairs or getting out of a chair. Many people mistake this as a normal part of aging which means diagnosis is delayed in many cases. Diagnosis often does not occur until other symptoms like tremor of stiffness occur. With time, normal walking becomes difficult and Parkinson’s patients often develop a 'shuffling' type of walk with difficulty in starting, stopping and turning. Stiffness of muscles (rigidity) is when the muscles become tense with the arms and legs tending not to swing as easily. Tremor is common symptom of Parkinson’s. For many people it is the symptom that leads them to seek treatment and thus allow diagnosis. However not all patients with Parkinson’s have tremor. About 30% of Parkinson’s patients do not suffer from tremor initially but it always develops as the condition progresses. It usually affects the fingers, thumbs, hands, and arms, but can affect any part of the body. It is most noticeable when resting. Tremors tend to worsen when anxious or emotional and tends to reduce when using your hands or picking up an object or moving the affected area.

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CPD 95: PARKINSON'S DISEASE The speed in which symptoms become worse varies from person to person. It can take several years before symptoms become bad enough to affect routine tasks and quality of life. In many cases one side of the body may be more affected than the other initially but with time both sides are usually affected equally. As the condition develops and more dopamine receptors are destroyed, other symptoms develop. These include difficulty with balance and posture and an increased tendency to fall. Further symptoms include inability to perform facial expressions like smiling or frowning; reduced blinking; difficulty with fine movements such as using a scissors, tying shoelaces, opening and closing buttons, zipping up and difficulty with writing (handwriting tends to become smaller). There can be a slowdown in speech leading to a monotone voice and swallowing difficulties can develop leading to pooling of saliva in the mouth. Tiredness, aches and pains are other possible symptoms. Other symptoms which occur in some people as the condition develops include: • Bladder symptoms including incontinence • Constipation • Sweating • Sexual difficulties. • Alterations in sense of smell • Sleeping problems (can be disturbed sleep at night or excessive sleep during the day) • Hallucinations • Weight loss • Pain • Depression • Anxiety Diagnosis There is no specific test to diagnose Parkinson’s. Diagnosis is based the typical symptoms. It may be difficult for diagnosis initially with many people not being diagnosed for years after developing the condition as symptoms are mild and may be mistaken as a normal part of aging. Parkinson’s is sometimes confused with other conditions that have some “Parkinson” type symptoms. Parkinson symptoms may occur in people suffering from neurological disorders such as Alzheimer's disease, Huntington's disease, Wilson's disease, spinocerebellar ataxias and Creutzfeldt-Jakob disease

(better known as “mad cow disease”). Other conditions that can occasionally display symptoms similar to Parkinson’s include brain injury, brain infections (such as encephalitis), hyperthyroidism, brain tumour, liver disease, stroke, carbon monoxide poisoning and heavy metal (such as manganese) poisoning. Some medication can cause side effects that resemble symptoms of Parkinson’s. A form of Parkinson’s which is reversible sometimes develops from some antipsychotic drugs, especially 1st generation antipsychotics such as chlorpromazine and haloperidol. Some anti-emetic medication (metoclopramide) and epilepsy medication (valproate) may also cause Parkinson type symptoms. Reducing the dose of these medications generally eases or stops the Parkinson type symptoms. A neurologist or a consultant specialising in elderly care usually makes the diagnosis of Parkinson’s. While a scan of the brain cannot determine if Parkinson’s is present it is sometimes used to differentiate Parkinson’s from other conditions that cause Parkinsonism features. Link between Parkinson's disease and dementia The thinking part of the brain is not affected by Parkinson’s, so dementia is not a usual early feature. However, Parkinson’s increases the risk of developing dementia. Approximately 40% of patients with Parkinson’s develop dementia but dementia typically does not develop until 10 years or more after the first Parkinson symptoms occur.3 If dementia occurs, it generally develops in Parkinson patients over 70. The cholinesterase inhibitors rivastigmine (Exelon®), donepezil (Aricept®) and galantamine (Reminyl®) have been shown in studies to have a modest benefit in cognitive function and in the reduction of hallucinations and psychosis in patients with Parkinson related dementia. Rivastigmine5 appears to be most effective for Parkinson’s related dementia with donepezil to a lesser extent.6 Treatment While there is no cure for Parkinson’s, treatments can ease symptoms and slow progression. If diagnosis is early, medication is often started before symptoms become troublesome to slow progression. Medication Scottish Intercollegiate Guidelines Network (SIGN) which is an influential health guidance authority in the UK recommend starting with a dopamine

agonist (i.e. levodopa) with a dopa-decarboxylase inhibitor or a monoamine-oxidase inhibitor. There are other anti-Parkinson medicines available, but they are not used as often as the three types of medication described above but they can be used in addition to these to improve response. Levodopa is considered the most effective Parkinson treatment and is central to any pharma logical treatment regime.7 It can take 8 to 10 weeks from the start of treatment before the patient notices improvement in symptoms. Levodopa Levodopa tends to give a good improvement in symptoms. Levodopa is converted to dopamine in the brain. The dose is started low but tends to be increased to control symptoms. Levodopa is always used in combination with another medicine to prevent side effects (either benserazide or carbidopa). Benserazide and carbidopa prevent levodopa being converted to dopamine before it reaches the brain thus reducing side-effects. Levodopa combined with benserazide is called co-beneldopa (Madopar®) and levodopa combined with carbidopa is called co-careldopa (Sinemet®). Side effects from Levodopa tend to be rare at low doses. Nausea is the most common side effect. Other side effects which may occur include vomiting, dizziness and low blood pressure; however, these often ease after a few days of use and are minimised by starting with lower doses. Levodopa can occasionally cause compulsive behaviour in some people (eg) urge to gamble, spend money. The effect of Levodopa tends to wear off over time, usually over a period of 3 to 5 years. Problems that occur with time include 'on-off' effects; thus, alternating between being 'on' (being able to move freely), and being 'off' (not being able to move) in quick succession. Another side effect can be dyskinesia which is uncontrollable jerky movements which can be disabling, tiring and painful. Levodopa can cause other movement disorders such as head nodding, jerking and twitches. Movement disorders caused by Levodopa appear to come on quicker in younger patients (under 60) than older patients.3 Keeping the levodopa dose at the lowest that is effective to control Parkinson’s symptoms is the best way to reduce risk of movement disorders. Dopamine agonists Dopamine agonists mimic dopamine. There are several types. Ropinirole (Requip®), pramipexole (Mirapexin®) and rotigotine (Neupro® patch) are used most commonly. Bromocriptine (Parlodel®),

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CPD 95: PARKINSON'S DISEASE cabergoline or pergolide are used less often because of the risk of side effects which include thickening of heart valves and thickening or scarring of lung tissue.8 Initial side-effects are similar to levodopa (nausea, vomiting and dizziness) however side-effects tend to ease within a few days or weeks. Drowsiness can also occur. Like Levodopa, compulsive behaviour can be a side-effect; compulsive behaviour is more of a problem with dopamine agonists than levodopa. Dopamine agonists should be avoided in the treatment of patients with dementia because dopamine agonists can produce hallucinations. Despite being slightly less effective than Levodopa, one potential advantage of them as compared with levodopa is that their use is associated with at least a 50% lower risk of dyskinesia (involuntary movements) and other movement type side effects in the first four to five years of treatment, particularly among patients receiving dopamine-agonists on their own.9, 10, 11 Many doctors prescribe dopamine agonists as the first choice to delay the starting of levodopa as levodopa generally only works well for about five years, thus the longer you can hold off using levodopa, the longer it takes to get to the stage when it wears off.12 A dopamine agonist may be tried in combination with levodopa as the condition gets worse. Apomorphine is an alternative dopamine agonist that is used in combination with levodopa; it is administered as a subcutaneous injection. It is only used when the condition is no longer controlled by the main drugs used for Parkinson’s such as levodopa and is reserved for patients with severe 'off' episodes and immobility. As its effect wears off after about an hour, frequent injections are therefore needed, thus it is sometimes given as a continuous infusion. In trials comparing levodopa and dopamine agonists, symptoms of Parkinson’s improved with levodopa by about 40 to 50% as compared with approximately 30% with d opamine agonists.9,10,11 Mono-amine oxidase-B inhibitors Sometimes used as alternative to levodopa for early Parkinson’s. They include selegiline (Eldepryl®) and rasagiline (Azilect®). They work by inhibiting or blocking the effect of monoamine-oxidase-B (MAO-B) in the brain, a chemical that prevents the breakdown of levodopa and dopamine. Blocking the effect of MAO-B means the effect of dopamine lasts longer. Most Parkinson’s patients require levodopa eventually when the disease gets worse. MAO-B inhibitors are sometimes used

as the first treatment after diagnosis as it can delay the requirement for levodopa for months or years. MAO-Bs are often used in combination with levodopa as the condition progresses. Other medication used for Parkinson's disease Catechol-O-methyltransferase (COMT) inhibitors have become available in the last 20 years. Entacapone (Comtess® and also an ingredient in Stalevo®) is a COMT. COMT inhibitors are often given in combination to levodopa as it slows the breakdown of levodopa by the body, so a higher percentage of levodopa can get to the brain to work. A COMT inhibitor is often added to levodopa when levodopa is not controlling symptoms sufficiently alone or where the effect of levodopa wears off. Hence Stalevo® has grown in popularity in recent years. Other medicines are sometimes used to help relieve symptoms. These medicines aim to correct the chemical imbalance in the brain. Examples include beta-blockers, amantadine and anticholinergic drugs. However, they are only a temporary or add on therapy as levodopa or dopamine agonists are the mainstay and the most effective therapies available for Parkinson’s. NON-DRUG TREATMENT OPTIONS Therapies A physiotherapist can advise and help with movement. They will concentrate on posture, walking and exercises, thus maximising the length the person can move and manage independently. An occupational therapist can advise on areas that will make the person’s day to day living easier to manage and will advise on home adaptations and devices which can simplify tasks that become difficult due to the condition. A speech and language therapist can help if difficulties with speech, swallowing or saliva occur; these difficulties normally only occur later on in the condition. Surgery Surgery was not traditionally part of Parkinson’s treatment and is not still commonly used as a form of treatment and techniques are still in the early days of development. Surgery will not cure Parkinson’s but may help ease symptoms when medicines are not working well. An example of a surgical procedure for chronic Parkinson’s is a technique that involves putting a pulse generator (like a heart pacemaker) in the chest wall. Fine cables are placed under the skin; they connect to electrodes placed in the brain. The electrodes stimulate parts of the brain

affected by Parkinson’s and can help to ease symptoms. Clinical trials are still underway for this therapy as long-term safety of this surgery is not certain. Deep brain stimulation is not yet available in Ireland and you must travel to the UK for treatment with this technique under the HSE. GENERAL ADVICE Stay as active as possible Exercise regularly as much as you are able. Exercise may not be possible as the condition progresses. Walking and movement may be slower than before but walking regularly can help loosen up stiff muscles and will help maintain and improve balance which will make falls less likely. Constipation Constipation is common with Parkinson’s as the nerves which allow the bowels to move freely are not functioning as well. Prevention includes staying well hydrated and eating plenty of fruit and veg and high fibre foods. Exercise can also improve constipation. Laxatives may be required as the disease progresses. Side effects of medication Familiarise yourself with any possible side effects of medication so you can recognise them early and deal with them promptly if they occur. Speak to your doctor and pharmacist about possible side effects and ‘Patient Information Leaflets’ that come with the medicines are an important source of information. You should inform your doctor or pharmacist of any side effects. For example, hallucinations, confusion and mental changes are possible side-effects of some medicines used to treat Parkinson’s. Bear in mind a lot of Parkinson medication is advised before food as they are absorbed better on an empty stomach; this can make compliance more challenging as in some case patients must take levodopa type medications up to 6 times daily and in later stages of Parkinson’s, polypharmacy can become a significant challenge. Driving Your doctor can advise if driving is still possible. Depending on the severity of symptoms and the medication prescribed, driving may still be possible following a medical assessment. Depression Depression is thought to occur in approximately 40% of patients with Parkinson’s Disease.3 The main reason for depression is the massive impact

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CPD 95: PARKINSON'S DISEASE

Parkinson’s can have on day to day living and life expectancy. Depression can cause symptoms similar to Parkinson’s and which may make it look like Parkinson’s is getting worse when actually it is not (such as lack of energy and becoming slower). Psychosis Psychosis may occur in up to 30% of patients with Parkinsons.13 It often presents as hallucinations which are usually visual together with delusions and agitation or occasionally aggressive behaviour. Paranoia may occur particularly towards partners and family members. Psychosis is thought to be due to the loss of dopamine receptors in the substantia nigra region of the brain. Older “typical” antipsychotics such as chlorpromazine (Clonactil®, Largactil®) and haloperidol (Serenace®) can worsen symptoms of Parkinson’s including movement and should be avoided. The newer “atypical” antipsychotic agents such as quetiapine (Seroquel®) and clozapine are better tolerated and often effective in controlling psychosis. Close monitoring of the white cell count is important with clozapine because of a 1% chance of a serious condition called agranulocytosis (a loss of the white blood cells which reduces the ability to fight infection). Acetylcholinesterase inhibitors such as the anti-Alzheimer’s drugs rivastigmine (Exelon®), donepezil (Aricept®) and galantamine (Reminyl®) may also be beneficial in reducing hallucinations and delusions in Parkinson patients. Practical tips Limit caffeine intake as caffeine can act as a diuretic and increase the frequency of urination. Decrease fluids to either two hours before bedtime, after dinner or earlier; this will reduce waking up at night to use the bathroom. Sleep deprivation can exacerbate symptoms of Parkinson's. At night, a portable urinal and or bedpan can be an alternative to getting out of bed to make trips to the bathroom which can be difficult. Using a shower stall is much easier and much safer than a shower/tub combination. The shower area should be fitted with at least two handrails. It is easier to get up from a high chair than from a low couch. Consider using Velcro fasteners instead of buttons; carrying a walking stick when out can increase confidence if unsteadiness is a problem. Use an electric toothbrush and razor to make brushing your teeth and shaving easier. There are many utensils designed for people living with disability which can make everyday chores like eating, preparing food easier, grooming and cleaning easier. Examples include reaching

devices, electric jar openers, modified cups and utensils for ease of holding and use, the list is limitless. Occupational therapist or pharmacist can advise on options. Longer term outlook Symptoms tend to get worse with time, but the speed of progression may vary significantly from person to person. Many do not need treatment initially as symptoms may be relatively mild. Most diagnosed with Parkinson’s Disease have a period of relatively mild symptoms. When symptoms become worse, medication can give several years of good or reasonable control of the symptoms. It is difficult to predict how quick the condition will progress. Some people may only have mild symptoms 20 years after diagnosis with others being disabled after only 10 years. Parkinson’s Association of Ireland The Parkinson’s Association of Ireland provides support for Parkinson’s patients, their families, carers and healthcare professionals. They operate a Freephone number (1800 359 359, Monday to Friday 9am to 9pm), they have a nurse on staff, provide free information leaflets and organise regular information evenings around Ireland. They also operate 14 branches around Ireland which operate on a local basis and are run by volunteer committees. They are a great source of information and support to both those living with the condition and loved ones of those affected. Their website www.parkinsons.ie is a great source of information and support. References 1. Mutch WJ, Dingwall-Fordyce I, Downie AW et al. Parkinson’s disease in a Scottish City. British Medical Journal. 1986; 292, 534–536 2. Wooten GF, Currie LJ, Bovbjerg VE, Lee JK, Patrie J. Are men at greater risk for Parkinson’s disease than women? Journal of Neurology, Neurosurgery & Psychiatry. 2004; 75:637-9 3. Davie, C.A. A review of Parkinson’s disease. British Medical Bulletin. April 2008; 86: 109–127

with Parkinson’s disease. New England Journal of Medicine. 2004; 351, 2509–2518 6. Ravina B, Putt M, Siderowf A et al. Donepezil for dementia in Parkinson’s disease: a randomised, double blind, placebo controlled, crossover study. Journal of Neurology, Neurosurgery & Psychiatry. 2005; 76, 934–939 7. Nutt JG, Wooten GF, Diagnosis and initial management of Parkinson’s disease. Clinical Practice. New England Journal of Medicine. 2005; 353;1021-7 8. Pritchett AM, Morrison JF, Edwards WD, Schaff HV, Connolly HM, Espinosa RE. Valvular heart disease in patients taking pergolide. Mayo Clinical Proceedings. 2002; 77:1280-6 9. Lees AJ, Katzenschlager R, Head J, Ben Shlomo Y. Ten-year follow-up of three different initial treatments in de-novo PD: a randomized trial. Neurology 2001;57: 1687-94 10. Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson’s disease who were treated with ropinirole or levodopa. New England Journal of Medicine. 2000;342: 1484-91 11. Holloway RG, Shoulson I, Fahn S, et al. Pramipexole versus levodopa as initial treatment for Parkinson disease: a 4-year randomized controlled trial. Archives of Neurology. 2004; 61:104453 12. Braak H, Bohl JR, Muller CM et al. Stanley Fahn Lecture 2005: The staging procedure for the inclusion body pathology associated with sporadic Parkinson’s disease reconsidered. Movement Disorders. 2006; 21, 2042–2051 13. Naimark D, Jackson E, Rockwell E et al. Psychotic symptoms in Parkinson’s disease patients with dementia. Journal of the American Geriatric Society. 1996; 44, 296–299.

4. Hughes AJ, Daniel SE, Ben-Shlomo Y et al. The accuracy of diagnosis of Parkinsonian syndromes in a specialist movement disorder service. Brain. 2002; 125, 861–870 5. Emre M, Aarsland D, Albanese A et al. Rivastigmine for dementia associated

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See SmPC for full list of side effects and further information. Legal classification: P. PA 1120/1/3. MAH: Wrafton Laboratories Ltd. (T/A Perrigo), Braunton, Devon, EX33 2DL, UK. RRP (ex. VAT): 10 €7.60 Date of preparation Apr 2018. http://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA1120-001-003_14022018144055.pdf Perrigo Cold & Flu Multi Relief Capsules, Paracetamol 500 mg, Guaifenesin 200 mg, Phenylephrine 6.1 mg. For the relief of symptoms of colds and flu and the pain and congestion of sinusitis, including aches and pains, headache, blocked nose, sore throat, lowering of temperature, and to loosen stubborn mucus and provide relief from chesty coughs. Adults, the elderly and children aged 16 years and over: Two capsules every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. Do not give to children under 16 years. Not to be continued for over 3 days without consulting a doctor. 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Contraindications: Hypersensitivity to any of the ingredients, hepatic or severe renal impairment, cardiovascular disorders, hyperthyroidism, diabetes, phaeochromocytoma, glaucoma, urinary retention, patients taking tricyclic antidepressants or beta-blockers, patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors, or those currently receiving other sympathomimetic drugs. Precautions: Circulatory disorders myasthenia gravis, severe gastrointestinal diseases, glucose-6-phosphatedehydrogenase deficiency, haemolytic anaemia, glutathione deficiency, asthma, those on a controlled sodium diet. Patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. May be harmful to people with phenylketonuria. May act as cerebral stimulant. Do not take with alcohol. Pregnancy and lactation: Not to be taken during pregnancy or whilst breast feeding. Side effects (unknown frequency): Thrombocytopenia, agranulocytosis, anaphylaxis, cutaneous hypersensitivity reactions, bronchospasm, hepatic dysfunction, acute pancreatitis. See SmPC for full list of side effects and further information. Legal classification: P. PA 1891/3/. MAH: Wrafton Laboratories Ltd. (T/A Perrigo), Braunton, Devon, EX33 2DL, UK. RRP (ex. VAT): 10 €5.15. Date of preparation Apr 2018. https://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA1891-003-001_19022018162036.pdf Perrigo Cold & Flu Tablets, Paracetamol 250 mg, Guaifenesin 100 mg, Phenylephrine 5 mg. For the relief of symptoms of colds and flu, including aches and pains, headache, blocked nose, sore throat, chills and chesty coughs. Adults, the elderly and children aged 12 years and over: Two tablets every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. Children under 12 years: Not to be used unless recommended by a doctor. Not to be continued for over 3 days without consulting a doctor. 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Special Report

The Life of a Pharmacy Locum Locums are an integral cog in the wheel of community pharmacy and IPN reached out to two highly experienced locum pharmacists to give readers an idea of what it’s like living the Life of a Locum. bring along new ideas and protocols, which can lead to a better and more efficient service for the patient. In terms of the dispensary, I have worked under several standard operating procedures and have been able to see what works and what doesn't work when trying to improve efficiency and safety. I can bring these ideas to new pharmacies. For example, I suggested a system in one pharmacy whereby we packaged the blister packs in advance of patients coming in to collect their medication by using a diary and better planning. The superintendent pharmacist thought this was a great idea and implemented it, which improved efficiencies in the dispensary and helped to cut patient waiting times.”

Niamh Mone, Pharmacist

Niamh Mone currently works in a GP practice as a full time pharmacist and still locums on weekends. Before that, Mone locumed for five years. Here she tells IPN about what it’s like working as a full time locum. “The main reason why I prefer locuming is the fact that I can be my own boss. I can decide what days I want to work, where I want to work and I can negotiate my own wage. The wages are slightly better and you have fewer responsibilities in terms of controlled drug audits and the pharmacy assessment folder, etc, but there can be disadvantages too, such as discontinuity, and if you are in a new place all the time it can be difficult to build up a rapport with

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the patients. I usually locum for a few regular pharmacies and have been able to build up good relationships with the staff and patients. It's lovely to go in and see how everyone is getting on. I also end up working six or seven days a week because I have a problem in saying no to work!” IPN asked what benefits can having a locum on duty have for the patient, and for the dispensary. “All pharmacists have different interests and specialties. For example, I'm interested in diabetes and cardiovascular. For patient queries, sometimes another opinion from a different pharmacist isn't a bad thing. New pharmacists coming into the dispensary can also

IPN asked if Mone would recommend a newly qualified pharmacist enters locuming. “Yes, I would. It's a good way to see how different pharmacies and pharmacists work, to learn new skills and to gain knowledge on other computer systems. You will also learn about certain things that might not crop up in other pharmacies, for example methadone, the health amendment scheme and the hardship schemes.” Mone has some advice for people who want to make it as a pharmacy locum. “When I started out, I went around to my local pharmacies with my business card and introduced myself to the supervising pharmacists or pharmacy owners. It helped them put a face to my name and showed them that I was a professional and competent person. I shadowed a few pharmacists first to ensure I had the competence to go out on my own and I also called down to one of the locum agencies in Dublin to introduce myself and make them aware of my experience. I made a Linkedin account to make it easier to

network with other pharmacists and created a website for bookings which a lot of business owners told me was really handy for them. I found that all of these steps made it easy to start my locuming career.” Mone says there are pitfalls that pharmacy locums need to be aware of. “Sometimes it can be problematic when, for example, things crop up in your own life. Even though you are not directly employed you still need to be accountable to whoever has booked you, but at the same time your responsibility, like everyone else, lies first with your family. I was in the unfortunate position recently where I had to bring a close family member to A&E on a Sunday but I was booked to locum on the same day and I had to cancel at short notice. Luckily I was able to help the store find a replacement but the impact of letting people down is one thing that locums need to be aware of because if they think you are unreliable they just won’t book you again. Your reputation is very important in this game: pharmacy is a small world and pharmacists talk among themselves so it is important to build up a good reputation. But the reverse is also true: we locums also talk among ourselves, such as if we have problems getting paid from a particular store. I’m still chasing a day's wages that was unpaid last year, I’ve learned the hard way” John Madden is a locum pharmacist living in Kilkenny. He graduated from UCC in 2008 and first registered with the PSI at the end of 2009, after a year in Newpark Pharmacy, Kilkenny. “Most of the work I've done since has been as a locum. Locuming was flexible enough to give me the opportunity to study further and I also found it the best way of exerting control over my circumstances. There is a certain freedom that comes with being a locum, you can be your


own boss to the extent that you can make yourself unavailable on certain dates, or resist going back to certain pharmacies. There's also a certain novelty that comes with locuming, traveling to different towns, hearing different accents, and seeing different customs. Also, it helps give more variety to one's professional experience.” IPN asked Madden what issues crop up for locum pharmacists that may not be so common with regular pharmacists. “Locums are caught in this weird limbo between being an employee and being self-employed. By any normal definition you're an employee; you work the shop's hours, follow the shop's usual procedures and can't subcontract the work; but you're not really treated as such, but more as an irregular staff member. There isn't any job security: the rate can fluctuate and you're susceptible to changes in the environment. There can be issues with pay, e.g. being paid late or no accompanying payslip. Entitlements like holidays or bank-holiday pay are often overlooked. There isn't sick pay. Common working perks like a pension contribution are non-existent. As a locum, particularly a first time locum, you're really just there to keep the doors open and interfere as little as possible. If you're returning, you might feel more confident taking on more responsibility. Every pharmacy will have its quirks, but these take time and experience to become acquainted with. Expectations of how much you should contribute vary, and aren't always made clear. Nor are they easily facilitated by having adequate staffing and resources, and can be further hindered by sloppy housekeeping. Entering a new pharmacy for the first time can be daunting and a new permanent member of

John Madden, Pharmacist

staff would be given time to assimilate, but locums often aren't afforded this luxury.” IPN asked Madden what the biggest issues in terms of working conditions are for both C regular pharmacists and locum pharmacists alike these days. M “The most glaring incidence Y of this is that the majority of CM pharmacists are expected to work without a lunch break, and MY this is a clear breach of the law, and is potentially also a safety CY issue. But this is just the thin CMY end of the wedge. Whatever K about eating lunch on the go, some pharmacies are so busy that having a cup of tea or even escaping to use the toilet can be difficult. There are pharmacies without adequate heating or air-conditioning, no canteen or break-room, and cold unsanitary toilets. The hours are somewhat long and there's rarely a reprieve from all the time spent standing. It can be quite an isolating job and opportunities to liaise with peers are extremely rare. Generally speaking though, even at their lowest, pharmacists’ wages nearly always eclipse those of the average worker so there are ups and downs, as with any other profession.”

Every pharmacy will have its quirks, but these take time and experience to become acquainted with.


News Newly elected IPHA President wants to ‘speed up patient access’ to innovative medicines The Irish Pharmaceutical Healthcare Association (IPHA) has elected Aidan Lynch as its new President. Lynch is currently the Vice President and General Manager of GSK (Ireland) Limited and in his new position with the IPHA, “will represent the research-based pharmaceutical industry in Ireland whose companies are discovering and manufacturing innovative medicines that enhance and save lives.” Lynch is a member of the Board of Barretstown Children’s Charity and has been a council member of the Dublin Chamber of Commerce since 2012. Until recently, Lynch held the role of President of the British Irish Chamber of Commerce.

The Irish Pharmaceutical Healthcare Association (IPHA) represents the international research-based pharmaceutical industry in Ireland and members include both manufacturers of prescription medicines and non-prescription or consumer healthcare medicines.

Commenting on his election, Lynch said: “I am excited to be taking up the Presidency of IPHA at such an important time for our industry. Our industry, made up of pharmaceutical innovators, has a major stake in Ireland’s future.

Prior to joining GSK, Lynch worked in the music and food industries in Ireland having returned from Australia where he lived for 14 years.

“Our medicines are helping people live longer, healthier lives; our scientists are discovering tomorrow’s cures; and we are creating high-value jobs in a fast-growing economy. But we face challenges. Among these is closing the gap between access and innovation, as Irish patients are still not getting access to the innovative medicines we make fast enough.

Aidan Lynch, new president of the IPHA

“Partnership will be a key theme of my Presidency, as we focus on partnering with government and policy makers to speed up patient access to innovative medicines and ensure a sustainable future for Ireland as a world leader in the discovery and manufacture of medicines.”

Prior to being appointed General Manager in October 2012, Lynch held a number of financial and commercial roles in GSK. In 2014, he was appointed President of the British Irish Chamber of Commerce and was re-elected to the Board of the Dublin Chamber of Commerce.

Drinking during puberty linked to prostate cancer risk Boys who drink alcohol from young age have a higher risk of developing aggressive prostate cancer, new research shows, presenting an intervention opportunity for community pharmacists. Compared with males aged 15 to 19 who do not drink, those who had at least seven alcoholic beverages a week were three times more likely to be diagnosed with a high-grade form of prostate cancer. The research, funded by the Irish Cancer Society and published in Cancer Prevention Research, was led by Dubliner Dr Emma Allott at the Gillings School of Global Public Health in the US “The prostate is an organ that grows rapidly during puberty, so it’s potentially more susceptible to carcinogenic exposure during the adolescent years,” Dr Allott said. “For this reason, we wanted to investigate if heavy

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alcohol consumption in early life was associated with the aggressiveness of prostate cancer later.” Dr Allott and her colleagues evaluated data from 650 men who underwent a prostate biopsy between 2007 and 2018. The men, aged 49 to 89, had no prior history of prostate cancer. They completed questionnaires to assess the average amount of alcohol they drank weekly during each decade of life to determine age-specific and cumulative lifetime alcohol intake. The researchers found that heavy alcohol intake at ages during teenage years was not associated

with overall prostate cancer in later life, but that having at least seven drinks a week during this age was associated with a higher risk of developing high-grade prostate cancer compared. Similar associations were observed among the men who consumed at least seven alcoholic drinks a week in their 20s, 30s and 40s, compared with nondrinkers. The study also found that current alcohol consumption was not significantly associated with high-grade prostate cancer. “Our results may explain why previous evidence linking alcohol intake and prostate cancer has been somewhat mixed,” Dr Allott said. “It’s possible that the effect

of alcohol comes from a lifetime intake, or from intake earlier in life rather than alcohol patterns around the time of diagnosis of prostate cancer.” The researchers noted that the heavy drinkers in the study were often also heavy smokers, and that despite adjusting their model for smoking, residual confounding may exist. Those who were heavy drinkers in their teenage years typically continued to drink heavily, the researchers noted, making it difficult to definitively separate the effects of early-life alcohol exposure from cumulative lifetime exposure.


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Benzydamine hydrochloride/Cetylpyridinium chloride Septabene lozenges and spray: The spray solution and lozenges contain benzydamine hydrochloride and cetylpyridinium chloride. Septabene spray: Indicated for adults and children aged 6 years and over for anti-inflammatory, analgesic and antiseptic treatment of irritations in the throat, mouth and gums, in gingivitis, pharyngitis, laryngitis and before and after tooth extractions. Septabene lozenges: Indicated for anti-inflammatory, analgesic and antiseptic treatment of symptoms of sore throat associated with upper respiratory infections including pharyngitis, laryngitis and tonsilitis. Children from 6 to 12 years of age: The recommended dosage is 3 lozenges a day. The lozenge should be slowly dissolved in the mouth every 3-6 hours. For a single dose of the spray, press the spray head once. This may be repeated every 2 hours 3-5 times a day. Adults, elderly and children over 12 years of age: The recommended dosage is 3-4 lozenges a day. The lozenge should be slowly dissolved in the mouth every 3–6 hours. For a single dose of the spray, press the spray head once to twice. This may be repeated every 2 hours 3-5 times a day. Precautions: Septabene should not be used for more than 7 days. If there is no improvement after 3 days, the patient should consult a doctor. The use of topical preparations, especially over a long period of time, may lead to sensitization, in which case the treatment must be discontinued and doctor consulted to set up a suitable therapy. Septabene must not be used in combination with anionic compounds, such as those present in toothpastes, therefore it is not recommended to use the product immediately before or after cleaning teeth. Benzydamine use is not advisable in patients with hypersensitivity to salicylates (e.g. acetylsalicylic acid and salicylic acid) or other NSAIDs. Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma. Caution should be exercised in these patients. Septabene should not be used in patients with open wounds or ulcerations in the mouth or throat. Septabene contains isomalt (E953). Patients with rare hereditary problems of fructose intolerance should not take this medicine. Direct contact of Septabene spray solution with eyes should be avoided. Septabene spray contains small amounts of ethanol. Contraindications: Septabene lozenges and spray: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the SPC. Children aged under 6 years: The pharmaceutical form is not appropriate for this age group. Fertility, pregnancy and lactation: There are no or limited amount of data from the use of benzydamine hydrochloride and cetylpyridinium chloride in pregnant women. Septabene is not recommended during pregnancy. It is unknown whether benzydamine hydrochloride (metabolites) are excreted in human milk. A risk to the newborns and infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue (abstain from) Septabene therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Adverse reactions: Septabene lozenges and spray: Rare: Hypersensitivity reaction, bronchospasm, urticaria, photosensitivity. Very rare: Oral mucosal irritation, burning oral sensation. Not known: Burning mucosa, anaesthesia of oral mucosa. Shelf life: 2 years. Legal category: Medicinal product not subject to medical prescription. Marketing authorisation number: Septabene spray PA1347/049/001, Septabene lozenges PA1347/063/001. Marketing authorisation holder: Krka, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia. SPC: http://www.hpra.ie/homepage/medicines/medicines-information/ find-a-medicine/results?query=septabene&field= Date of preparation: June 2017. Additional information is available on request from Krka Pharma Dublin Ltd. Unit 4A, Leopardstown Business Centre, Ballyogan Road, Leopardstown, Dublin 18. D18 KX88. Reference number: 01-02-2018.


Feature

Helping to improve outcomes for psoriasis sufferers Irish Pharmacy News examines one of the most common and distressing skin conditions in Ireland, Psoriasis, looking at the both the physical and often unreported psychological impact on sufferers of the condition. surface in an immature form, causing a build-up of silvery scale (dead skin cells). There is also an increased blood flow to the skin and a thickening of the epidermis, leading to the development of red, raised plaques. The physical appearance of psoriasis is very distinctive with patches of silvery or red skin appearing, which can lead to localised lesions developing on the patient's scalp, elbows, knees, torso, back, hands and feet. Symptoms include extreme dryness, scales, redness and inflammation, which can be both uncomfortable and unsightly. The Irish Skin Foundation reports that psoriasis is a condition which tends to run in families. Several different genes have been identified but the exact way in which the disorder moves from generation to generation has not yet been established.

Skincare expert Selene Daly has warned about the prevalence of psoriasis in Ireland

"The number of people with psoriasis in Ireland could fill Croke Park with a queue forming the length of Jones Road," skincare expert, Selene Daly, told RTE earlier this year. Daly, a dermatology clinical nurse specialist, was not exaggerating with her estimation. Psoriasis, one of the most common skin conditions in Ireland, affects an estimated 100,000 people here. Overall it is part of a range of skin conditions that affects, at any one time, more than one third of Irish people and results in 2.2 million visits to the GP annually.

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According to the Irish Skin Foundation, psoriasis, which affects 2% of the general population, is a chronic, systemic, inflammatory skin disorder in which there is an increase in the rate at which skin cells are produced and shed from the skin. Normally, skin cells reproduce and mature as they move from the deeper layers of the epidermis to the surface. This process is called proliferation and usually takes approximately 28 days. In psoriasis, this process is accelerated, only taking about four days. The new skin cells reproduce too quickly and move toward the skin

What is known is that both the immune system and genetics are important in its development. So although the potential to develop psoriasis is genetically inherited, it is by no means certain that it will ever occur. While it can affect people at all ages of their lives, the condition usually appears for the first time between the ages of 15 and 35. Environmental factors can also play a role in developing the condition. In some cases, emotional stress, infection, injury to the skin or certain medications can trigger the first episode of it, while certain lifestyle factors (such as heavy drinking and smoking) may worsen it. A third of suffers can be affected by psoriatic arthritis, which, if left untreated, can cause permanent damage to the affected joints, while a study has shown that as the condition's severity increased so too did the patient's chances of heart disease, diabetes, and liver disease..

Plaque psoriasis Plaque psoriasis is the most common form of psoriasis, affecting approximately 90% of patients. The plaques can vary in number, size, and location but the sites most frequently affected are the knees, elbows, scalp and sacrum (lower back). The plaques are often itchy and painful, and can crack and bleed. The extent of the skin surface involved can range from 1-100%. Erythrodermic psoriasis is the term used to describe instances where almost the entire body surface is involved, and is characterised by red skin with a diffuse, fine, peeling scale. It is quite rare, generally occurring in those who have unstable plaque psoriasis. Psychological impact The physical impact of the condition is only part of the story. Most international studies of people suffering from psoriasis believes the social stigma is more distressing than the condition itself. It is estimated that three out of four people suffering from the condition will avoid situations where their psoriasis plaques might be visible. Research findings have cited that women (61%) were likely than men (39%) to avoid social situations because of their condition, while half of respondents said that their psoriasis had led to reduced confidence over time. GPs and pharmacists may be often aware of the physical symptoms associated with the condition, but patients may not be sharing the psychological consequences with them. With this in mind, both doctors and pharmacists should help with alleviating this burden. Research has also showed that a quarter of people living with psoriasis felt that people treat them differently


Superior results for your patients with moderate to severe plaque psoriasis1* 5 years of sustained efficacy and a consistent safety profile2

Complete Treatment† Complete Confidence

ABBREVIATED PRESCRIBING INFORMATION ▼ COSENTYX 150 mg solution for injection in pre-filled pen. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions. Please refer to the Summary of Product Characteristics (SmPC) before prescribing. Presentation: COSENTYX 150 mg solution for injection in pre-filled pen. Therapeutic Indications: The treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy; the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy; the treatment, alone or in combination with methotrexate (MTX), of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate. Dosage & Method of Administration: Plaque Psoriasis: Recommended dose in adults is 300 mg given as two subcutaneous injections of 150 mg. Dosing at Weeks 0, 1, 2 3 and 4, followed by monthly maintenance dosing. Ankylosing Spondylitis: The recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 3 and 4, followed by monthly maintenance dosing. Psoriatic Arthritis: For patients with concomitant moderate to severe plaque psoriasis or who are anti TNFα inadequate responders, the recommended dose is 300 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 3 and 4, followed by monthly maintenance dosing. Each 300 mg dose is given as two subcutaneous injections of 150 mg. For all other patients, the recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. For all of the above indications, available data suggest that a clinical response is usually achieved within 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients who have shown no response up to 16 weeks of treatment. Some patients with initially partial response may subsequently improve with continued treatment beyond 16 weeks. The safety and efficacy in children below the age of 18 years have not yet been established. Contraindications: Severe hypersensitivity reactions to the active substance or to any of the excipients. Clinically important, active infection (e.g. active tuberculosis). Warnings/Precautions: Infections: Cosentyx has the potential to increase the risk of infections. Infections observed in clinical studies are mainly mild or moderate upper respiratory tract infections such as nasopharyngitis not requiring treatment discontinuation. Non serious mucocutaneous candida infections more frequently reported for secukinumab than placebo in psoriasis clinical studies. Caution in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, close monitoring and discontinue treatment until

the infection resolves. Should not be given to patients with active tuberculosis. Anti tuberculosis therapy should be considered prior to initiation in patients with latent tuberculosis. Crohn’s disease: Caution should be exercised when prescribing to patients with Crohn’s disease as exacerbations of Crohn’s disease, in some cases serious, were observed in clinical studies. Close monitoring of patients with Crohn’s disease treated with Cosentyx. Hypersensitivity reactions: In clinical studies, rare cases of anaphylactic reactions have been observed in patients receiving Cosentyx. If an anaphylactic or other serious allergic reactions occur, administration should be discontinued immediately and appropriate therapy initiated. Latexsensitive individuals: The removable cap of the Cosentyx pre filled pen contains a derivative of natural rubber latex. Vaccinations: Live vaccines should not be given concurrently with Cosentyx. Patients may receive concurrent inactivated or non live vaccinations. Concomitant immunosuppressive therapy: Use in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. Interactions: Live vaccines should not be given concurrently with Cosentyx. In a study in subjects with plaque psoriasis, no interaction was observed between secukinumab and midazolam (CYP 3A4 substrate. No interaction seen when administered concomitantly with methotrexate (MTX) and/or corticosteroids. Fertility, Pregnancy and Lactation: Women of childbearing potential should use an effective method of contraception during treatment and for at least 20 weeks after treatment. It is preferable to avoid the use of Cosentyx in pregnancy as there are no adequate data from the use of secukinumab in pregnant women. It is not known whether secukinumab is excreted in human milk. A decision on whether to discontinue breast feeding during treatment and up to 20 weeks after treatment or to discontinue therapy with Cosentyx must be made taking into account the benefit of breast feeding to the child and the benefit of Cosentyx therapy to the woman. The effect of secukinumab on human fertility has not been evaluated. Undesirable Effects: Very common (≥1/10); Upper respiratory tract infections. Common (≥1/100 to <1/10); Oral herpes, rhinorrhoea, diarrhoea, urticaria Uncommon (≥1/1,000 to <1/100); Oral candidiasis, tinea pedis, otitis externa, neutropenia, conjunctivitis. Rare (≥1/10,000 to <1/1,000) Anaphylactic reactions. Please see Summary of Product Characteristics for further information on undesirable effects. Legal Category: POM. Marketing Authorisation Holder: Novartis Europharm Ltd, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland. Marketing Authorisation Numbers: EU/1/14/980/004-005. Date of Revision of Abbreviated Prescribing Information: April 2018. Full prescribing information is available upon request from: Novartis Ireland Limited, Vista Building, Elm Park Business Park, Elm Park, Dublin 4. Tel: 01-2204100 or at www. medicines.ie. Detailed information on this product is also available on the website of the European Medicines Agency http://www.ema.europa.eu

* Secukinumab was shown to be superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis in 52-week, double-blind study, in which subjects were randomized 1:1 to subcutaneous injection of secukinumab 300 mg or ustekinumab per label. Primary end point was 90% or more improvement from baseline Psoriasis Area and Severity Index score (PASI 90) at week 16.1 † Complete refers to the fact that Cosentyx has demonstrated efficacy in various manifestations of psoriasis (psoriatic arthritis, nail, scalp and palmoplantar)3,4 References: 1. Thaçi D et al. J Am Acad Dermatol 2015; 73(3): 400-409. 2. Bissonnette et al. J Eur Acad Dermatol Venereol 2018: doi: 10.1111/jdv.14878. 3. Kavanaugh A et al. Arthritis Care Res 2017; 69; 347-355. 4. Reich et al. Poster 7382 presented at AAD 2018. Date of Preparation: August 2018 IE02/COS18-CNF043


Feature and work with patients’ physicians to ensure adjustments to their treatment plan are made if necessary. While most case of psoriasis require a prescription medications, some over-the-counter (OTC) products can help, especially in mild cases. Pharmacists will need to do their research and talk to GPS about the best OTC remedies for patients with psoriasis. These may include: Emollients Lubricating bath products Hydrocortisone Coal tar products Keratolytic agents Plaque psoriasis is the most common form of psoriasis

because of their condition and one in five believe they would have more friends if they didn't have the condition. The World Psoriasis Happiness Report 2017, which aimed to shed light on what impacts the subjective well-being interpreted as happiness of people with psoriasis, made for some very interesting reading. The report is built on the Guidelines for Measuring Subjective Well-being developed by the Organization for Economic Cooperation and Development (OECD) and looks across a wide spectrum of validated indicators measuring quality of life, such as stress and loneliness. The study showed that living with psoriasis impacts people’s quality of life across a wide spectrum of subjective well-being indicators. When people report severe symptoms, they also report lower levels of happiness. Using the World Happiness Report 2017 as a benchmark, the study found that people living with severe psoriasis in some countries report 30% lower levels of happiness than their fellow citizens. Some 48% of respondents felt that their healthcare professionals did not fully understand the impact psoriasis

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has on their mental well-being and experience happiness gaps of 21%. Meanwhile, the 52% who felt that their healthcare professionals do fully understand the impact psoriasis has on their mental well-being only experience happiness gaps of 3%. According to the report, while both men and women with psoriasis are very much affected physically, emotionally and psychologically, the impact on women is greater. Compared to their countrymen and countrywomen, men and women living with severe psoriasis report respectively 11.3% and 18.5% lower levels of happiness. Women consistently reported higher levels of stress and loneliness than men. The different symptoms of psoriasis, such as scaling, itchiness and trouble walking have different effects on happiness. While 'scaling' is associated with 11.7% lower happiness levels, 'trouble walking' is associated with 22% lower happiness levels compared to the average population. This pattern is consistent across the different levels of disease severity. Also highlighted in the reported was that psoriasis on the scalp is associated with a 7.5% happiness gap, while psoriasis on the genitals

impacts happiness with a 12.9% happiness gap. Stress is the best psychological predictor of unhappiness for people living with psoriasis, with 60% reporting feeling distressed in a moderate to extreme degree in their lives. Using the most conservative threshold for loneliness, the report also found that 33% of all people living with psoriasis are lonely. Pharmacists' help The community pharmacy can play an important role in helping patients with psoriasis manage their conditions and improve outcomes. The first step in treating a patient with psoriasis is education. If patients don’t fully understand their condition and its severity, they may not properly adhere to treatment plans. When filling prescriptions for patients with psoriasis, pharmacists are advised to talk to them about the disease. Educate them on the medication their physician prescribed and discuss possible side effects. Community pharmacists are in an ideal position to closely monitor patients with psoriasis and keep track of their progress. They can get to know your patients with psoriasis; conduct regular medication reviews to monitor adherence and determine if the medications they’re using are working;

Before making a recommendation, pharmacists should consult with patients about their current medication regimen and skin condition to determine which products will be the safest and most effective. Generally, all patients will be prescribed total emollient therapy (soap substitutes and moisturisers) in combination with topical steroids and something called vitamin D analogues such as Dovonex. Psoriasis patients can also be prescribed something called phototherapy which is an artificial form of sunlight carried out in dermatology departments three times per week for 6-8 weeks. There are also tablets and injection medications available to treat psoriasis and which are only available from hospital-based consultant dermatologists. Also, it is important for pharmacists to make the patients aware that the longterm or overuse of strong corticosteroid creams can both reduce the creams effectiveness and cause thinning of the skin. Other topical treatments can irritate the skin and cause sensitivity to light as in the case of topical retinoids. If topical medical treatment is being used, it's advised the patient knows to wait 10 minutes between its application and the application of the specialist body cream.


Doublebase™ Emollient Gel Fine tuned for the management of dry skin and conditions such as eczema or psoriasis

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The innovative GEL formulation of Doublebase Emollient Gel looks different from and performs differently to other moisturisers. Doublebase Emollient Gel is simple to apply, it easily absorbs when smoothed into the skin and can start to work from the first application. Clinically proven to provide effective protection against dryness. Suitable for all ages, including babies.

Recommend Doublebase Emollient Gel to soften, moisturise and protect dry skin and conditions such as eczema or psoriasis. Doublebase Emollient Gel Therapeutic ingredients: Isopropyl myristate 15% w/w, liquid paraffin 15% w/w. Presentation: White opaque gel. Uses: Highly moisturising and protective hydrating gel for regular and frequent use in the management of dry skin conditions such as eczema, psoriasis or ichthyosis. Directions: Adults, the elderly, infants and children: Apply directly to dry skin as often as needed. It may also be applied before washing, showering or bathing to prevent further drying of the skin. Contra-indications, warnings, side effects etc: Do not use if sensitive to any of the ingredients. In the rare event of a reaction stop treatment. Care should be taken as emollients which soak into clothing, pyjamas, bedlinen etc. can increase the flammability of these items. Patients should avoid these materials coming into contact with naked flames or lit

cigarettes etc. As a precaution, dressings and clothing, etc., should be changed frequently and laundered thoroughly. Ingredients: Isopropyl myristate, liquid paraffin, glycerol, carbomer, sorbitan laurate, trolamine, phenoxyethanol, purified water. Pack sizes: 100g tube and 250g pump pack. Legal category: Class I medical device. Further information is available from the manufacturer: Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK. Date of preparation: December 2017. ‘Doublebase’ is a trademark. 11mm Adverse events should be reported to Dermal.

DEGPR074/I/AUG18

Essential Information ™

Always read the label/leaflet.


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Film-Coated Tablets Paracetamol, Pseudoephedrine Hydrochloride

Powerful Relief From Sinus Pain & Congestion ESSENTIAL INFORMATION Solpa-Sinus Film-coated Tablets contain paracetamol and pseudoephedrine hydrochloride. For the relief of nasal congestion when combined with fever or pain such as sore throat, sinus pain or headache in the common cold or flu. Adults and children 16 years and over: 2 tablets up to 3 times daily, as required. Children aged 12–15 years: 1 tablet up to 3 times daily, as required. Do not give to children under 12 years. Leave at least 4 hours between doses. Max 3 doses in 24 hours. Seek medical advice if symptoms persist after 5 days. Contraindications: Severe renal impairment, hypertension, cardiovascular disease, hyperthyroidism, prostatic hypertrophy, glaucoma, concomitant or recent MAOI use, furazolidone, linezolid, beta-blockers, concomitant use of other sympathomimetics. Caution: Mild to moderate renal impairment, diabetes mellitus, arrhythmias, phaeochromocytoma, patients taking anti-hypertensives or about to undergo general anaesthesia. Interactions possible with warfarin and other coumarins, sodium bicarbonate, metoclopramide, domperidone, colestyramine. Side effects: Nervousness, insomnia, GI disturbances, dizziness, tachycardia, skin disorders, thrombocytopenia, agranulocytosis, hypersensitivity reactions, hepatic dysfunction. PA 1186/12/1. P. MAH: Chefaro Ireland Limited, 1st Floor, Block A, The Crescent Building, Northwood Office Park, Dublin 9. RRP (ex. VAT): €9.00. Date of preparation: September 2018.


News Accord Healthcare Ireland focusing on hi-tech & biosimilar medicines When Minister Harris opened the Sláintecare Programme Office in September he challenged all citizens and Health Service stakeholders to “roll up our sleeves and work together to create a world class health service we can all be proud of”. Accord Healthcare Ireland are rising to this challenge and playing their part to make the health service better for society and the country, so more Irish patients have access to the medicines they need when they need them. “We know expenditure on health has risen steadily since 2007 and 2018 will be no different”, says Padraic O’Brien, Accord’s Head of Commercial, “As our population ages and the number of us living longer with chronic illnesses increases, we believe generics can be one solution. Pharmacists are well aware of the savings offered by solid dose generics, but the savings which can be made from generic Hi Tech medicines are being overlooked. Government expenditure on the Hi Tech Scheme has continually increased; with spend growing by ¤335m or 96% over the period 2009 to 2016. By 2017, spend on the scheme rose to ¤662 million and is expected to continue to increase. As the budget fast approaches we urge the government to put a focus on the savings which can be made from Generic Hi Tech and Bio Similar medicines. “We in Accord have the widest range of Hi Tech medicines of any generic supplier on the Irish market and we continue to expand with

the launch of another Hi Tech later this year. Using generic Hi Tech medicines make sense” says Mr. O’Brien, “generic suppliers like ourselves in Accord have helped to save the state ¤1.6 billion euros since generic substitution was introduced in 2013, and we know if more backing was given to support the use of Hi Techs and Bio Similars, bringing us in line with the rest of Europe, we could offer the state even more savings. Our Hi Tech portfolio expands later this year with the launch of our second Bio Similar in Ireland Pelgraz”. “Along with our MFI colleagues we are calling for a reform of the Hi Tech medicines scheme including, placing off-patent Hi Tech solid dose medicines on the interchangeable list, immediately following patent expiry. Medicines included on the Hi Tech scheme must also be open to greater generic completion. These changes would free up substantial funds (approx. ¤20 million) for the Government to allocate to other areas of the Health Service therefore helping even more Irish citizens gain access to medicines,” said Mr. O’Brien. “Following on from the creation of Sláintecare whose goal is about a shared commitment to the best healthcare we can provide for

As our population ages and the number of us living longer with chronic illnesses increases, we believe generics can be one solution the Irish people. It is in this vein we are urging both HCPs and government to look to Generic Hi Tech suppliers and Bio Similars to make savings for the state. We have been supported greatly by pharmacists and health care professionals across the country who have got behind generic Hi Techs. Pharmacists really are playing their part and we ask that the government review the policies on Hi Tech and Bio Similar medicines, as we agree with Minister Harris, Irish citizens deserve a world class health

service to be proud of”, added Mr. O’Brien. “Approximately 9 million packs of our medicine are distributed in Ireland each year, meaning every four seconds a patient somewhere in Ireland takes an Accord medicine. We take this responsibility of providing Irish patients with high quality products very seriously and our team in Cork will continue to offer value, choice, service and support to our valued customers across the country into the future, concludes Mr. O’Brien.

Vat on condoms ‘a tax on safe sex’ The Irish Pharmacy Union (IPU) has called for the Government to eliminate VAT on condoms as part of its efforts to make contraception more affordable and easier to access. The call was made as part of a pre-Budget Submission which also included recommendations around increased access to oral contraception and vaccination services. Commenting, pharmacist Caitríona O’Ríordan, a member of the IPU Executive Committee said, “The Government has a stated objective to improve access to contraception and to reduce the rate of unplanned pregnancy, this also aligns with the strategy to improve sexual health in Ireland. There is currently a VAT rate of 13.5% on condoms, which is counterproductive and goes against these ambitions. This is essentially a tax on safe sex, and we are calling on the Minister for Finance to abolish this tax in the upcoming Budget.

“Condoms are the best protection against sexually transmitted infections and can reduce the risk of unplanned pregnancies. Reducing the cost of condoms and improving ease of access will increase their use, particularly among younger adults where cost has the biggest impact.”

women will have access to it, which should result in reduced rates of unintended pregnancy. There are no clinical reasons why oral contraceptives should still require a prescription. The oral contraceptive is one of the safest and most well studied medicines available.

The pre-Budget Submission also reiterates the IPU’s call to the government to put in place a scheme to enable women to access oral contraception (‘the pill’) directly from their community pharmacist without prescription or charge.

Ms O’Ríordan concluded, “The IPU believes that allowing pharmacists to work to their full scope will deliver better patient outcomes. The challenge now is to ensure that community pharmacy is empowered to deliver more for patients and the public into the future. Increasing access to contraception through pharmacies will be another step towards achieving this aim.”

According to Ms. O’Ríordan, “Access to birth control is a major public health issue because of the risk of unwanted pregnancies. By making birth control easier and more convenient to obtain, more

in place to enable women to be able to obtain oral contraception, i.e. the pill, directly from their pharmacist, without prescription or charge. "Access to birth control is a major public health issue because of the risk of unwanted pregnancies. By making birth control easier and more convenient to obtain, more women will have access to it, which should result in reduced rates of unintended pregnancy. "There are no clinical reasons why oral contraceptives should still require a prescription. The oral contraceptive is one of the safest and most well studied medicines available," Ms O'Riordan insisted.

The IPU is also again calling on the Government to put a scheme

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Falsified Medicines Directive Irish pharmacists prepare for Falsified Medicines Directive compliance deadline in February 2019 In order to continue selling medicines to consumers after 9 February 2019, all actors within the European supply chain must comply with new legally binding rules arising from the Falsified Medicines Directive (FMD). Irish Pharmacy News has been finding out what the directive is, why it matters - and importantly - what it means for you. of our patients through the illicit supply of counterfeit and substandard medicines and health products. If we have these challenges in high income countries we can consider that it is even more challenging in the low and middle income countries.” IPN spoke to the Head of regulation of medicines at the World Health Organisation, Emer Cooke, about these changes.

Dr Mariangela Simão, Assistant Director General for access to medicines, vaccines and pharmaceuticals at WHO

In 2016, more than 600,000 dosage units of false or substandard medicines were detained by Irish authorities. According to Ireland’s Health Products Regulatory Authority (HPRA) these items, mostly bought online, pose a real and substantial risk to people’s health and to their lives. Health regulators and other authorities are having to innovate to keep up with rogue actors and criminals and it is estimated that globally up to 10% of medicines are substandard or falsified (SF). In Africa and Asia, that figure rises to a startling 42%. Dr Mariangela Simão is the assistant director-general for access to medicines, vaccines and pharmaceuticals at World Health Organisation (WHO). According to Dr Simão, “[s] ubstandard or falsified medicines not only have a tragic impact on individual patients and their families, but also are a threat to antimicrobial resistance,

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adding to the worrying trend of medicines losing their power to treat.” The WHO stopped using the term ‘counterfeit’ in respect of unsatisfactory medicines in 2017 and instead adopted the phrase ‘substandard or falsified’ (SF). The new terminology captures a broader definition of what poor quality drugs are and accounts for products that although may be legitimate in terms of their ingredients, may not be acceptable due to incomplete, missing or falsified paperwork. The word ‘counterfeit’ has been restored in practical terms to meaning a trademark violation, as defined under trade rules on intellectual property at the World Trade Organisation (WTO). Irish context Lorraine Nolan is the CEO of the HPRA. Despite the prevailing attitude that falsified medicines are not really that big of a problem in Ireland when

compared to other markets, the HPRA and other authorities are in a constant battle to reduce the number of SF items getting into the hands of Irish consumers and patients. “It is a growing issue worldwide and in Ireland alone we detained over 600,000 illicit medicines in 2016 , with over one million being detained in 2017. National and international collaboration and the sharing of information has been a crucial factor in successfully curtailing exploitation and protection of our citizens from dubious and substandard products.” Nolan welcomed the new measures, and acknowledged the different challenges faced by drug regulators around the world. The hope is that by closing the supply chain in Europe and other markets, patients everywhere will be protected from illicit traders. “[Regulators] are very aware of the potential for exploitation

“It’s very rarely a single country problem but is something that goes across borders … [WHO] published a study on the socioeconomic impact of substandard and falsified medicine last year and we reviewed 100 research articles which looked at the problem and we estimated the … cost to society was over $30 billion. These are rogue actors. Regulators are used to regulating the ‘good’ and these are the ‘bad’ and people will always find a way to try and cheat the system. But if we can raise awareness, if we can train regulators, if we can improve the laboratory systems I think we can do a lot better.” IPN asked if the rationale behind the directive and the need for its implementation has been communicated effectively to dispensers in high income markets. “It is a problem everywhere. Strong regulatory systems can catch it better, but the falsified [medicines] directive is enabling better control. The thing that … maybe national and regional regulators haven't been so good at is realising the connections that need to be made in a global marketplace. Problems tend to occur at the weakest link in the chain. When you've got a European system, how do you make sure this is working across all countries? You've got a global supply chain: what is happening to your


imports? What is happening to your exports? I really think the directive is needed and I think Europeans will see the benefit of it.” Protecting consumers The Directive (which is an amendment to Directive 2001/83/EC) has been designed to more rigorously protect the pharmaceutical supply chain by closing it through the adoption of serialisation and verification measures and procedures. The final step, decommissioning, happens at pharmacy dispensary level, and is a vital component in ending exploitation opportunities for criminals who profit from SF drug products. Decommissioning happens when the pharmacist scans the 2D barcode containing the serial number at dispensary level and is satisfied that the product they are dispensing has been verified on the repository that is connected to the centralised European hub. When a pharmacist decommissions a pack, it will be marked on the system as having been dispensed and the serial number will no longer be available for use. The directive also requires all prescription medication packages to have a tamper-proof seal. The Irish Medicines Verification Organisation (IMVO) was required by the directive to be established in advance of the compliance deadline. Tracelink is the world's largest track and trace network for connecting the life sciences supply chain and are one of the 12 software partners working with IMVO to provide solutions. Brian Daleiden is the Vice President of Tracelink. He is on record explaining how the serialisation and verification procedures will operate in practical terms. “The manufacturer needs to serialise drug product at the smallest saleable unit, and then they need to submit master data about that drug product and the serialisation information related to [it] to a central European hub. As the product moves into the supply chain, the primary responsibility for track and trace compliance then falls onto the dispensers - the pharmacies. Before they dispense the drug product that pharmacy needs to scan the barcode to verify a couple of pieces of information:

first off, to verify the serial number was actually created and applied to a drug product; the second is to check to find out if there’s any adverse states that the drug product exists in. Maybe [it] was marked as stolen, or marked as potentially counterfeit. When the pharmacist scans the product they can get information that says that this could be a questionable drug product, not just that the serial number exists.” Manufacturers in Ireland are currently shipping serialised products to markets in parts of the world that have already adopted similar measures to protect their drug product supply chain. Turkey is considered to be a pioneer in respect of serialising and tamper-proofing health products and Brazil, China, South Korea and the USA have followed suit. Implications for Irish dispensers After February 2019, anyone dispensing prescription medication will have to verify the product’s authenticity and decommission it from the IMVO repository before it can be supplied to the patient. There are a handful of exceptions (such as gases) and the directive does not apply to P or GSL items, with one exception, omeprazole gastro-resistant hard capsules. The legislation requires pharmaceutical manufacturers to meet the costs of establishing the national verification bodies, such as the IMVO in Ireland’s case, and pharmacists and wholesalers are similarly required to absorb whatever cost implications arise at dispensary level, such as through the purchase of essential equipment (i.e., scanners, software, hardware). IMVO is aiming to start connecting all end-users in early Autumn when the pilot project, which applies to 30 locations in Ireland, is completed. Leonie Clarke is the General Manager at IMVO. She spoke to IPN about the huge amount of work that is going on behind the scenes to ensure compliance by the February deadline. “A report on the pilot project in community pharmacy is expected to be made available from the IPU by the end of September and by then we

Dr Lorraine Nolan, Chief Executive of the HPRA

expect to have written out to all 1800 pharmacies in the jurisdiction, explaining to them what is expected and how we intend to support them. Online training in the form of webinars will be made available and we also expect by that stage to be in a position to have collated a table of information indicating to pharmacists who they can contact if something goes wrong. Our partners in the IPU have been regularly updating pharmacists of the anticipated changes and we at IMVO have been focused on planning things out so that there is clarity for all users. We have also streamlined procedures within our own organisation to ensure a smooth on-boarding process. Our focus is to learn from the pilot project so that we are fully prepared for all the issues that could arise. We expect to be in a position to start ramping up communications with pharmacists when the results of the pilot project have been collated.”

IMVO website has the following information for pharmacies about what steps can be taken in advance of the requirements becoming legally binding next February: • Identify where scanning will take place and what terminals need to be connected; • Upgrade existing software to interact with IMVO repository and/or installing a standalone system; • Implement necessary changes in work practices, procedures, etc.; • Have scanners in place to read barcodes; • Inform your team of what is happening and train relevant staff; • Considering how anti-tamper device checks will be managed.

It is a growing issue worldwide and in Ireland alone we detained over 600,000 illicit medicines in 2016 47


Feature

Bridging the gap between pain and relief IPN caught up with Perrigo’s training consultant, Sarah Whitehead to discuss OTC Analgesia and to understand how best to treat patients with the right OTC pain relief. As Sarah explains, it is critical that all members of the pharmacy team feel confident in advising customers. The key role of the pharmacy team

know when to advise a change in medication.

Given the wide and easy availability of mild pain relief treatment options, it is quite likely that those seeking advice at the pharmacy counter feel their pain is having a significant impact on their day-to-day life and that standard options, such as paracetamol and ibuprofen, might not be providing adequate pain relief.

Having a better understanding of how we experience and perceive pain may help to guide conversations to judge whether pain relief is adequate.

They may need a step up in treatment. The pharmacist and members of the pharmacy team are often the first healthcare providers people speak to about their pain. It is therefore critical that all members of the pharmacy team feel confident about how best to advise customers in this situation. Pain is an individual experience

Sarah Whitehead

48

Everyone experiences pain differently. This makes assessing pain perhaps one of the most difficult challenges faced by healthcare providers. Specifically, it can be hard to

How do we feel pain? A person’s overall experience of pain may therefore be more or less than another person with a similar condition or injury. It is important to judge pain based on the patient’s overall perception, rather than what may typically be expected given the cause of their pain. Asking the right questions is critical. Pain scales (like the one shown here) provide a way to help benchmark a person’s individual experience of pain. They help interpret the level of pain a person actually feels after the brain has processed them. Asking a customer ‘Where does it hurt?’ will give you a location on their body. However, this does not tell you anything about


®

SOLUBLE TABLETS

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Powerful Pain Relief *IMS Data July 2018

ESSENTIAL INFORMATION Solpadeine Soluble Tablets contain paracetamol, codeine phosphate hemihydrate and caffeine. For the treatment of acute moderate pain which is not relieved by paracetamol or ibuprofen alone, including migraine, headache, backache, menstrual pain, musculoskeletal pain, toothache, common cold, influenza. Adults and children 12 years and over: 2 tablets dissolved in water 3 – 4 times a day. Max 8 tablets in 24 hours. Do not give to children under 12 years. Do not take for more than 3 days without consulting a doctor. Do not take any other paracetamol or codeine containing products concurrently. Can cause addiction. Use for 3 days only. In case of overdose, seek immediate medical advice, even if the patient feels well. Contraindications: Acute asthma, known hypersensitivity to ingredients, lactation, known CYP2D6 ultra-rapid metabolisers, patients 0-18 years who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome. Precautions: Renal or hepatic impairment, non-cirrhotic alcoholic liver disease, obstructive bowel disorders, previous cholecystectomy, acute abdominal conditions, pregnancy, prostate hypertrophy, the elderly. Pregnancy and lactation: Not recommended during pregnancy and breastfeeding. Side effects: Thrombocytopenia, anaphylaxis, cutaneous hypersensitivity reactions, hepatic dysfunction, GI disturbance, dependency or worsening of headache following prolonged use. PA 1186/11/1. P. MAH: Chefaro Ireland Limited, 1st Floor, Block A, The Crescent Building, Northwood Office Park, Dublin 9. RRP (ex. VAT): 12 €5.40, 24 €8.50. Date of preparation August 2018.


Feature Event – Is the pain linked to any particular event or illness? Severity – How much pain are you in from a scale of 1 (no pain) to 10 (worst pain imaginable)? Sensation – Can you describe how it feels and where it is? Prescription/OTC medicines – What medicines have you tried to relieve your pain? Have you talked to your GP about your pain? Activity – How is the pain affecting your normal activities? eg restrict movement, affect sleep etc Interventions – Have you tried any non-pharmaceutical treatments to help relieve your pain? Eg RICE, physiotherapy etc Not mentioned issues – Is there anything else concerning you about your pain? Anything you feel is important but may not be easy to talk about? Treating pain at the right level Confidently setting pain relief at the right level can make a big difference to someone in pain. However, pain is widely undertreated1. the impact their pain may be having on their life. Being in pain can affect many aspects of day- to-day living and overall sense of wellbeing, and can be highly distressing and disruptive. Understanding the full impact that pain is having on your customer will help you discover whether their current pain relief is adequate.

LESS PAIN: An effective tool for discussing pain in pharmacy You may already be familiar with the eight ‘LESS PAIN’ questions devised by the University College London School of Pharmacy, listed below. Length – How long has the pain been troubling you?

The pharmacist and members of the pharmacy team are often the first healthcare providers people speak to about their pain. It is therefore critical that all members of the pharmacy team feel confident about how best to advise customers in this situation. 50

on the pain scale despite Step 1 treatment, it may be time to step up to a combination treatment, such as Solpadeine • Step 2 treatments aim to provide sufficient relief to allow self-management using lifestyle factors. This provides the best chance of rehabilitation and longer-term relief. When escalating to Step 2, provide your customer with lifestyle advice appropriate to their condition (e.g. RICE, gentle exercise). Step 2 to step 3 • If no relief is achieved after three days on a combination treatment (Step 2), check whether customer carried out / was able to carry out self-management – If yes, with no improvement – refer to GP – If no and customer is suitable for a repeat dose, reiterate importance of following lifestyle advice – If no and repeat dose is not appropriate, or you are unsure, refer to GP

The ‘LESS PAIN’ questions can be used to assess whether a person’s pain is impacting on their life, despite their current level of pain management.

Finally, it is important to be aware of what may stand in the way of a customer achieving adequate pain management and to bridge the gap towards pain relief. For example, if a customer is reluctant to step up, it may be due to a false perception or an unaddressed concern. In a recent survey* more than 50% of people do not realise that codeine and co-codamol are available in pharmacy and almost 40% of people said they would be more willing to try a stronger pain medication if they had a better understanding of potential side effects.

These questions include use of a pain scale (‘severity’) so you should also use this as a guide to cross check the level of analgesia typically recommended for the level of pain they are experiencing.

If you feel there could be a knowledge gap standing in the way of better pain management, it’s a good idea to check your customer’s understanding and beliefs about a step up in medication.

STEP-TO-STEP SCENARIOS

References:

Step 1 to step 2

1. Faculty of Pain Medicine of the Royal College of Anaesthetists. Core Standards for Pain Management Services (CSPMS) in the UK. Edition 1/2015. October 2015.

The pharmacist and pharmacy team play a key role in determining whether a step up in pain relief may benefit someone in pain, and the options available. What does inadequate management look like?

• Regular paracetamol (Step 1) can be very effective for pain management, so if a customer reports pain at around 4 to 6


Unlocking the growth in NRT Critical success factors to deliver sales growth Make the move to front of shop.

1

• Make NRT more accessible for quitters with a move to front of shop. • Offer a clear and defined NRT section to allow for visibility and interaction with products.

Understanding the Irish Smoker1 • 23% of the Irish Population are smokers, leading to 6,000 smoking related deaths each year. • Of that 1million smokers, 70% want to quit and on average will try to quit up to 7 times before success.

Pharmacy is the ideal home for Proactive Health Management

2

3

Advice from Pharmacy Staff

Remember that advice from Pharmacy Staff is vital in decision-making for NRT shoppers.

Breadth of formats & flavours

It is essential to have the right product mix for individual quitters needs.

Valuing the customer • NRT shoppers are highly valuable. • One successful quitter is worth €526* to your pharmacy. • Nicorette is the number 1 brand in theSmokers category worth €28M, death with 71% market share.2

4

vs sick etc

Proven Success Model

Proven success in Independent Pharmacy who have moved their NRT GSL products from behind counter to front of shop at the beginning of March 2018, delivering 18% YOY sales growth for Nicorette in March/April 2018.3

Contact your Johnson & Johnson Territory Manager now for further information and support materials. 1.Healthy Ireland Survey 2017. 2. IMS OIRMTH MAT March 2018. 3. EPOS April 2018.

*Based on 12 week quit journey with Nicorette Quickmist Duo pack.


Nicorette Icy White 2mg and 4mg Medicated Chewing Gum, Nicorette Invisi 10mg/16 hours, 15mg/16 hours Transdermal Patch. Nicorette 15mg Inhaler, Nicorette Cools 2mg Lozenges, Nicorette Quickmist 1mg/spray, oromucosal spray. Indications: For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit. Helping smokers temporarily abstain from smoking (Gum and Inhaler only). In smokers currently unable or not ready to stop smoking abruptly, Nicorette Gum, Inhaler and Lozenges may also be used as part of a programme to reduce smoking prior to stopping completely. Nicorette 2mg Gum or Nicorette Inhaler may be used in combination with Nicorette Invisi 10mg and 15mg Transdermal Patch for the treatment of tobacco dependence as part of a stop smoking programme. Dosage: Smoking cessation: Gum: The chewing gum should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. Not more than 15 pieces of the chewing gum may be used each day. Nicorette Gum may be used for up to 3 months during which time the habits associated with smoking will be lost. If not successful after 12 weeks the patient should be encouraged to make a fresh attempt to stop smoking. Inhaler: The frequency of use should depend on the previous smoking habit of the individual. Nicorette Inhaler should be used whenever the urge to smoke is felt, up to a maximum usage of 6 cartridges per day. In the treatment of nicotine dependence, a course not exceeding three months is suggested, the patient stopping smoking completely at the start of the course. Patch: Heavy smokers are recommended to start at Step 1 with the 25 mg/ 16 hours patch and use one patch daily for 8 weeks (Pharmacy only product). Gradual weaning from the patch should then be initiated. One 15 mg/16 hours patch should be used daily for 2 weeks followed by one 10 mg/16 hours patch daily for 2 weeks. Light smokers are recommended to start at Step 2 (15 mg) for 8 weeks and decrease the dose to Step 3 (10 mg) for the final 4 weeks. Lozenges: Nicorette 2mg Lozenges are suitable for smokers with low nicotine dependency e.g. those smoking their first cigarette of the day more than 30 minutes after waking up or those who smoke fewer than 20 cigarettes per day. Nicorette 4mg Lozenges are suitable for smokers with high nicotine dependency e.g. those smoking their first cigarette of the day 30 minutes after waking up or those who smoke more than 20 cigarettes per day. Lozenges should not be used for more than 9 months. One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately 16-19 minutes). The lozenge should not be chewed or swallowed whole. Sufficient lozenges should be used each day and most smokers usually require 8 to 12, not to exceed 15 lozenges. The duration of treatment is individual, but up to six weeks treatment is recommended to break the habit of smoking. The nicotine dose should then be gradually reduced, by decreasing the total number of lozenges used per day. The treatment should be stopped, when the daily consumption is down to 1-2 lozenges. Quickmist: After priming, point the spray nozzle as close to the open mouth as possible. Press the top of the dispenser and release one spray into the mouth, avoiding the lips. Step I: Weeks 1-6: Use 1 or 2 sprays when cigarettes normally would have been smoked or if cravings emerge. If after a single spray cravings are not controlled within a few minutes, a second spray should be used. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays. Most smokers will require 1-2 sprays every 30 minutes to 1 hour. Step II: Weeks 7-9: Start reducing the number of sprays per day. By the end of week 9 subjects should be using half the average number of sprays per day that was used in Step I. Step III: Weeks 10-12: Continue reducing the number of sprays per day so that subjects are not using more than 4 sprays per day during week 12. When subjects have reduced to 2-4 sprays per day, the oromucosal spray use should be discontinued. Temporary Abstinence: During periods of temporary abstinence, the patient should use Nicorette Gum or Inhaler when required to relieve nicotine cravings and withdrawal symptoms. Gradual cessation: For smokers who are unwilling or unable to quit abruptly. Use the gum/inhaler/Lozenge whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. The number of cartridges/gums/lozenges is variable and depends on the patient’s needs. Not more than 15 pieces of the gum, 6 cartridges, 15 lozenges should be used per day. If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought. Reduced tobacco consumption should lead to complete cessation of smoking. A quit attempt should be made as soon as the number of cigarettes has been reduced to a level whereby the smoker feels ready to quit completely, then start as outlined for “smoking cessation” as given above. Combination therapy (15mg/10mg patch and 2mg gum or Inhaler): Step 1: The Nicorette Invisi 15mg Patch would be applied daily on waking for 16 hours and removed just before bedtime for a total of 8 weeks. The Nicorette 2mg medicated chewing gum or Nicorette Inhaler would be used ad libitum when the smoker felt an urge to smoke or in situations where he/she feels that breakthrough cravings may occur, up to a maximum of 15 pieces of gum per day or 6 cartridges per day. Step 2: After the initial 8 weeks the lower dose Nicorette Invisi 10mg Patch should be used for a total of 4 weeks. The Nicorette 2mg medicated chewing gum or Nicorette Inhaler would be used ad libitum when the smoker felt an urge to smoke or in situations where he/she feels that breakthrough cravings may occur, up to a maximum of 15 pieces of gum per day or 6 cartridges per day. Step 3: Use of the Nicorette Invisi Patch should be stopped after the 12 week treatment program. The Nicorette 2 mg medicated chewing gum or Nicorette Inhaler can continue to be used for a further 3 months during which time the habits associated with smoking will be lost. Contraindications: Use in non-smokers, Use in persons hypersensitive to nicotine or any ingredient in the formulation. Children under the age of 12 years (Lozenges) or under 18 years (Quickmist). Special Warnings and Precautions: The benefits of quitting smoking outweigh any risks associated with correctly administered nicotine replacement therapy (NRT). A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions: - Cardiovascular disease: Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, recent cerebrovascular accident, and/or who suffer with uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicorette Gum may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision. Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects. Gastrointestinal Disease: Nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and NRT preparations should be used with caution in these conditions. Phaeochromocytoma and uncontrolled hyperthyroidism: Nicotine, both from NRT and smoking, causes the release of catecholamines from the adrenal medulla. Therefore, Nicorette should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma. - Diabetes Mellitus. Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when smoking is stopped and NRT is initiated, as reductions in nicotine-induced catecholamine release can affect carbohydrate metabolism. Patients with diabetes mellitus may require lower doses of insulin as a result of smoking cessation. - Smokers who wear dentures may experience difficulties in chewing Nicorette Gum. The chewing gum may stick to, and may in rare cases damage dentures. Transferred dependence: Nicotine in any dose form is capable of inducing a dependence syndrome after chronic use and is highly toxic after acute use. However, dependence with Nicorette Gum is a rare side-effect and is both less harmful and easier to break than smoking dependence. Danger in children: Doses of nicotine tolerated by smokers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be handled or ingested by children. Nicorette Inhaler should be used with caution in smokers with chronic throat diseases and bronchospastic disease. The oromucosal spray contains small amounts of ethanol (alcohol), less than 100 mg per spray. Care should be taken not to spray the eyes whilst administering the oromucosal spray. Nicorette Inhaler should be used with caution in smokers with chronic throat diseases and bronchospastic disease Nicorette Invisi Patch should be removed prior to undergoing any Magnetic Resonance Imaging (MRI) procedures to prevent the risk of burns. Undesirable Effects: Effects of Smoking Cessation: Regardless of the means used, a variety of symptoms are known to be associated with quitting habitual tobacco use. These include emotional or cognitive effects such as dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating, and restlessness or impatience. There may also be physical effects such as decreased heart rate; increased appetite or weight gain, dizziness or presyncopal symptoms, cough, constipation, gingival bleeding or aphthous ulceration or nasopharyngitis. In addition, and of clinical significance, nicotine cravings may result in profound urges to smoke. Adverse Drug Reactions: Nicorette may cause dose dependent adverse reactions similar to those associated with nicotine administered by other means and are dose dependent. Most of the undesirable effects reported by the subjects occur during the early phase of treatment. Gum: Immune System Disorders: Hypersensitivity - Common Anaphylactic reaction - Not known. Psychiatric Disorders – Abnormal Dreams – Uncommon. Nervous System Disorders: Headache - Very Common, Burning sensation, Dysgeusia, Paraesthesia – Common. Eye Disorders: Blurred Vision, Lacrimation increased – Common. Cardiac Disorders: Palpitations, Tachycardia - Not known. Vascular Disorders: Flushing, Hypertension – Uncommon. Respiratory, Thoracic and Mediastinal Disorders: Cough, Throat irritation - Very common. Bronchospasm, Dysphonia, Dyspnoea, Nasal Congestion, Sneezing, Throat tightness – Uncommon. Gastrointestinal Disorders: Hiccups, Nausea - Very common. Abdominal pain: Diarrhoea, Dry mouth, Dyspepsia, Flatulence, Salivary hypersecretion, Stomatitis, Vomiting – Common. Eructation Glossitis, Oral mucosal blistering and exfoliation, Paraesthesia oral – Uncommon. Dysphagia, Hypoaesthesia oral, Retching – Rare. Dry throat, Gastrointestinal discomfort Lip pain - Not known. Skin and Subcutaneous Tissue: Hyperhidrosis, Pruritus, Rash, Urticaria Disorders – Uncommon. Erythema - Not known. Musculoskeletal and Connective Tissue Disorders: Pain in jaw – Uncommon. Muscle tightness - Not known. General Disorders and Administration Site Conditions: Fatigue – Common. Asthenia, Chest discomfort and pain, Malaise – Uncommon. Allergic reactions including angioedema - Rare. Inhaler: Immune system disorders: Common – Hypersensitivity. Not known - Anaphylactic reaction. Psychiatric Disorders – Abnormal Dreams – Uncommon. Nervous system disorders Very common Headache Common Burning sensation Dysgeusia Paraesthesia Eye disorders Not known Blurred vision Lacrimation increased Cardiac disorders Uncommon Palpitations Tachycardia Vascular disorders Uncommon Flushing Hypertension Respiratory, thoracic and mediastinal disorders Very common Cough Throat irritation Bronchospasm Dysphonia Dyspnoea Nasal congestion Sneezing Throat tightness Gastrointestinal disorders Very common Hiccups Nausea Common Abdominal pain Diarrhoea Dry mouth Dyspepsia Flatulence Salivary hypersecretion Stomatitis Vomiting Uncommon Eructation Glossitis Oral mucosal blistering and exfoliation. Paraesthesia oral Rare Dysphagia Hypoaesthesia oral Retching Not known Dry throat Gastrointestinal discomfort Lip pain Skin and subcutaneous disorder Uncommon Hyperhidrosis Pruritus Rash Urticaria Not known Angioedema Erythema Muscoskeletal and connective tissue disorders Uncommon Pain in jaw Not known Muscle tightness . General disorders and administration site conditions Common Fatigue Uncommon Asthenia Chest discomfort and pain Malaise. Patch: Immune system disorder Uncommon Hypersensitivity Rare Anaphylactic reaction Nervous system disorder Common Headache Uncommon Paraesthesia Cardiac disorders Uncommon Palpitations Tachycardia Vascular disorders Uncommon Flushing Hypertension Respiratory, Thoracic and Mediastinal Disorders Uncommon Dyspnoea Gastrointestinal disorders: Common Nausea Vomiting Rare Gastrointestinal discomfort and/or pain Skin and subcutaneous tissue disorders Very common Pruritus Common Rash Urticaria Uncommon Hyperhidrosis Rare Angioedema Erythema Musculoskeletal and Connective Tissue Disorders Uncommon Myalgia Rare Pain in extremity General disorders and administration site conditions: Uncommon Application site reactions Asthenia Chest discomfort and pain Malaise Fatigue. Lozenge: Immune System Disorders: hypersensitivity (including allergic and anaphylactic reactions), angioedema. Psychiatric disorders: irritability, anxiety, sleep disorders incl. abnormal dreams, nervousness, depression. Nervous system disorders: dizziness, headaches. Cardiac Disorders: palpitations, heart rate increased, atrial arrhythmia. Respiratory, thoracic and mediastinal disorders: cough, sore throat. Gastrointestinal disorders: nausea, mouth/throat and tongue irritation, vomiting, diarrhoea, gastro-intestinal discomfort and/or pain, flatulence, hiccups, heartburn, dyspepsia. Skin and Subcutaneous Tissue Disorders: rash, erythema, urticaria. General Disorders and Administration Site Conditions: fatigue, malaise, chest pain. QuickMist: Immune system disorders Common Hypersensitivity Not known Allergic reactions including angioedema and anaphylaxis Psychiatric disorders Uncommon Abnormal dream Nervous system disorders Very common Headache Common Dysgeusia, paraesthesia Eye disorders Not known Blurred vision, lacrimation increased Cardiac disorders Uncommon Palpitations, tachycardia, Atrial fibrillation Vascular disorders Uncommon Flushing, hypertension Respiratory, thoracic and mediastinal disorders Very common Hiccups, throat irritation Uncommon Bronchospasm, Rhinorrea, dysphonia, dyspnoea, nasal congestion, oropharyngeal pain, sneezing, throat tightness Gastrointestinal disorders Very common Nausea Common Abdominal pain, dry mouth, diarrhoea, dyspepsia, flatulence, salivary hypersecretion, stomatitis, vomiting Uncommon Eructation, gingival bleeding, glossitis, oral mucosal blistering and exfoliation, paraesthesia oral Rare Dysphagia, hypoaesthesia oral, retching Not known Dry throat, gastrointestinal discomfort, lip pain Skin and subcutaneous tissue disorders Uncommon Hyperhidrosis, pruritus, rash, urticaria Not known Erythema General disorders and administration site conditions Common Burning sensation, fatigue Uncommon Asthenia, chest discomfort and pain, malaise Marketing Authorisation Holder: Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland. Marketing Authorisation Number: Icy White Gum – PA 330/37/8. Patch – PA 330/37/5-6. Inhaler - PA 330/37/10. Quickmist - PA 330/37/13. Lozenge – PA 330/37/11. Date of Revision of the Text: PA 330/37/8 – April 2018. PA 330/37/5-6 – June 2018. PA 330/37/13 – April 2018. PA 330/37/10 – April 2018. PA 330/37/11 – April 2018. Legal Category: Products not subject to medical prescription. Further information available upon request from Johnson & Johnson (Ireland) Ltd.

IRE/NI/18-3310


Feature

Mouth cancer - pharmacists vital in fight against ‘silent killer’ PHARMACISTS play a key role in the national fight against mouth cancer, according to leading experts. dry mouth and persistent unexplained halitosis.

extensive post-treatment therapy long after their cancer is gone.

Up to 50 per cent of mouth cancers and even fewer cancers of the pharynx are diagnosed early, according to official figures from the National Cancer Registry.

Mouth and throat cancers in men and women are becoming more common and a high percentage of these cancers are caused by the Human Papilloma Virus (HPV), he warned.

The statistics show there are more than 400 cases of cancer of the mouth (oral cavity and pharynx) annually. These cancers mainly affect the elderly and are more common in men. Those most at risk include the homeless. However, cancer of the mouth in women has increased significantly at a rate of three per cent per year since 1994. Failure to discover the illness early can mean more complex treatment with greater impact on quality of life and overall survival.

James Paul O’Neill, Professor of Otolaryngology, Head and Neck Surgery, Beaumont Hospital Early detection and education can help win the battle against this deadly illness, branded ‘the silent killer’. Now, as part of Mouth Cancer Awareness Day pharmacists and other health professionals joined forces to combat mouth cancer, responsible for two deaths each week. “Any customer presenting with a non-healing mouth ulcer should be referred onto their local dentist for further investigation. Early detection saves lives,” Dr Kieran O’Connor, President of the Irish Dental Association (IDA) told Irish Pharmacy News. “Pharmacists can help by displaying and distributing Mouth Cancer Awareness leaflets to their customers.” It is also vital that pharmacists are familiar with the symptoms of mouth cancer to aid early detection. The most prominent and easily identifiable symptom of oral cancer is an ulcer with a raised edge, which may discharge blood. These ulcers are not always painful and may even have been dismissed or forgotten about by the patient. Patients should be asked how long they have had an ulcer. Anything over three weeks should ring alarm

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bells and the patient should be referred to a specialist urgently. However, most cases of oral cancer do not present as ulcers in their early stages. Recent studies have identified that many oral cancers in their early stages manifest as irregularities in the oral cavity, usually in the form of red or white patches that can have an irregular surface texture or appearance. Again, further questioning is vital in informing any referrals. If a patient says he/she has had these symptoms for some time, this can severely affect the chances of survival if it turns out to be oral cancer.

As well as HPV, tobacco, alcohol, poor dental hygiene and bad diet are leading causes of the disease. But the good news is improving nutrition, attending regular dental and medical check-ups and maintaining oral hygiene can help you avoid this debilitating cancer that is sometimes preceded by precancerous growths. Identifying these growths can improve long-term survival, according to research from Scientists at Trinity’s School of Dental Science

“Early detection of mouth cancer greatly improves the chances of survival,” says the Irish Cancer Society.

For example, one of the pre-cancers is called oral leukoplakia, meaning white-patch and is visible on the mouth.

James Paul O’Neill, Professor of Otolaryngology, Head and Neck Surgery, at the RCSI Education and Research Centre, Beaumont Hospital, agrees: “While advances in cancer research means that survival rates for these cancers are gradually increasing, the treatments patients undergo can have life-long and life-changing effects,” Professor O’Neill said recently.

The Trinity research investigated bacteria linked to oral leukoplakia and how it could help flag whether a condition will become malignant.

“Cancer survivors can be left with difficulties in swallowing and speaking, and may require

Oral cancer is the eighth most common cancer worldwide. Like all cancers, early diagnosis greatly improves the long term outcome. Overall, cancer survival rates are improving, and patients are living longer with a decent quality of life thanks to research and advances in detection and treatment.

Other symptoms of oral cancer include unusual lumps or swellings in the mouth or the head and neck area. If swelling occurs in the neck area, then it suggests enlarged lymph nodes – a common symptom or oral cancer. These lumps are usually persistent and slowly increase in size over time. It may also be possible to identify further oral cancer symptoms such as weight loss, unexplained numbness in the mouth, difficulty moving the jaw, speech problems due to swelling of the tongue, persistent pain in the mouth, difficulty swallowing, persistent

Ulcers can often be an early sign of mouth cancer


Feature

The pharmacist’s role in assisting Alzheimer’s patients in the community Dementia is the medical term used to describe a range of incurable conditions that over time cause damage to the brain. Alzheimer’s disease, which is a degenerative condition, is the most common form of dementia. Symptoms include memory loss and impaired cognitive function. Progress of dementia cannot be stopped, however early intervention with services and medication can help to improve the patient’s quality of life and can lessen some of the symptoms. Together campaign are encouraging when compared to a similar study carried out in January 2016, indicating that attitudes towards Alzheimer’s and dementia among Irish people over the past number of years are evolving, and may even be improving.

Cormac Cahill, communications manager at the Alzheimer Society of Ireland

The number of Irish people living with the disease is set to more than double from 55,000 to 113,000 by 2036 and the month of September is designated internationally as World Alzheimer's month. To mark the occasion the Dementia: Understand Together campaign shared the results of a survey it carried out earlier in the year. Reaching the population with a message that timely diagnosis is key can ensure patients access the appropriate services and supports, and can help when patients and their families are making decisions about future care. Cormac Cahill is communications manager at the Alzheimer Society of Ireland. He has the following advice for community pharmacists

about how they can assist a patient who is living with this disease. “Pharmacies provide a key service for people with dementia and their family carers to enable them to remain living in their community. Customers will often ask staff for advice about their condition: medication, management and what supports are available. Do not underestimate the difference you can make if you have a basic understanding about the practical ways you can support people living with [this disease]. People with dementia have told The Alzheimer Society of Ireland that it is the attitude of those they meet in providing services which makes the biggest difference to their experience.” The results of the study released by the Dementia: Understand

The following findings were considered to be significant: one in three respondents (33%) described themselves as knowing a lot about the disease, up from 24% in the earlier study. Women (38%) were more likely than men (27%) to indicate understanding, while those in the 50-64 years age group were most aware. More than three quarters of respondents indicated that they understood that early diagnosis is key. Despite this, still some 24% of people indicated that they would delay seeking help if they had concerns for their own well being. 52% of respondents told researchers that they were aware they could reduce their own risk of dementia through lifestyle choices, up from 46% in the previous study. Three in five people (59%) said that they were impacted in some way when they saw the Dementia: Understand Together TV campaign. 56% said they would not be ashamed or embarrassed of a diagnosis. Brian Lawlor is a consultant psychiatrist and is chair of the Dementia: Understand Together campaign. Professor Lawlor says that while the results of the latest study are encouraging, there is no room for complacency. “It is positive to see an increase in the number of people who are aware that there are things they can do to potentially reduce their risk of dementia – now at 52%, up from 46% in the previous

survey. We all need to take a more active role in managing our brain health, by eating healthy, not smoking, avoiding excess alcohol, getting our blood pressure checked and treated, and by being active physically, mentally and socially.” The Alzheimer’s Society of Ireland prepared the following information for pharmacists to guide them when supporting and signposting people in need of their professional assistance. How do you know if a person needs help? Everyday challenges differ for people with dementia; in relation to their medication management they can experience a range of difficulties. Look out for these signs: • The medications that are used to treat some symptoms of dementia. • Problems, such as remembering to take medication, taking them at the right times, the right dose, or remembering where they are stored. • Difficulty in managing their existing medications. • Forgetting to get prescriptions renewed from their GP or repeatedly returning with prescription renewals. The Alzheimer Society of Ireland National Helpline is open six days a week Monday to Friday 10am–5pm and Saturday 10am–4pm on 1800 341 341.

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News news brief NEW HEAD OF INTERNATIONAL PHARMACEUTICAL FEDERATION Swiss pharmacist Dominique Jordan has been elected as president of the International Pharmaceutical Federation. Mr Jordan, a community pharmacy owner, has served the federation for more than a decade, including as chair of its Board of Pharmaceutical Practice. “Around the globe, health systems face changes due to new trends and demographic, political and economic challenges,” Mr Jordan said. “Taking into account the work of past presidents, I will give new impulses to grow and use the unique potential that our federation has, gathering science, practice and education under one roof,” Mr Jordan said. Mr Jordan took office in September and will serve a four year term.

US TAX CUTS 'EXTREMELY UNLIKELY' TO HURT PHARMA JOBS IN IRELAND The chief economist to the White House has declared that reforms to the US corporate tax code will not deter American companies from investing in Ireland.

Chanelle Group goes from strength to strength An Irish pharmaceutical company specialising in parasite treatments for pets will hire up to 350 staff over the next five years. The Chanelle Group announced it was building a new facility at its expansive Galway headquarters, as part of a more than ¤86m investment in Ireland. Construction of a the new manufacturing facility will begin next year. Chanelle Group is Ireland’s largest manufacturer of generic medicines for human and animal health, with sales last year in excess of ¤111 million. The company, founded in 1985, employs more than 500 people and exports its products to 96 countries. Tánaiste Simon Coveney officially opened a new manufacturing facility at its Loughrea site last month. The 30,000 square foot facility, worth ¤10 million, is Europe’s first dedicated ‘Spot On’ manufacturing facility built to European and US quality standards. Spot On is a topical treatment used to protect dogs and cats against parasites. “Chanelle Group is one of Ireland’s leading exporters in the manufacture of veterinary and

"I don't think we should think of it as sucking factories out of Ireland," he said. President Donald Trump’s administration has criticised Ireland's "chronic" trade surplus with the US, which is dominated by pharmaceutical exports to the US by American companies registered in Ireland. American companies employ about 150,000 people in Ireland.

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“The investment announced today is the largest by owner Michael Burke in the history of the company and through Enterprise Ireland, the government is pleased to support Michael as he grows Chanelle Group and creates valuable employment here in Loughrea.” Michael Burke, owner and managing director of Chanelle Group, said the company had already invested more than ¤55 million and created 175 jobs in its global Loughrea headquarters since 2016. “Over the next five years we will increase the pace of our investment programme, investing ¤86 million in our operations and creating 350 new jobs, bringing total employment to over 850 people,” he said. Julie Sinnamon, chief executive of Enterprise Ireland, described the Chanelle Group as a “global leader.”

Michael Burke, owner and MD of Chanelle Group

“This investment programme of ¤86 million is one of the largest investments by any Irish company in the history of Enterprise Ireland and its impact on the local and regional economy will be significant,” she said.

Irish drugmaker sold for ¤540 million The Irish pharmaceutical company behind a front-line opioid rescue drug now commonly used in the United States has been sold for more than half a billion euros.

Kevin Hassett, chairman of the Council of Economic Advisors, told The Sunday Independent it was "extremely unlikely" that American multinationals would close or stop maintaining their subsidiaries in Ireland. But Mr Hassett said the recent reduction in the US corporate income tax rate - from 35% to 21% - would result in more companies choosing America for new investments.

human pharmaceuticals, trading with over 90 countries worldwide,” Mr Coveney said.

Seamus Mulligan, chairman and chief executive officer of Adapt Dublin-based Adapt Pharma, which developed a non-injectable form of Naloxone, will be acquired by Emergent BioSolutions, the companies have announced. Branded as Narcan, the nasal spray blocks the effects of drugs such as heroin and fentanyl to revive overdose victims, and can be administered by people without medical training. The drug has been touted as a front-line treatment to combat the opioid drug crisis in the US, which claimed more tens of thousands of lives every year from overdoses.

Seamus Mulligan, chairman and chief executive officer of Adapt, said the deal will see the company focus on critical treatments to combat the opioid crisis, "one of the leading public health issues of our time."

the Federal government, and Adapt’s demonstrated success with state and local government, first responder, and commercial channels, we expect to combine efforts to address the opioid overdose epidemic," he said.

"With a shared mission of protecting lives from public health threats, I am confident that our combined expertise and resources will accelerate access to NARCAN® Nasal Spray through investments in public awareness and manufacturing capacity while maintaining a responsible pricing approach," he said.

"We look forward to welcoming the Adapt team so together we can further expand awareness and availability of this potentially life-saving treatment against this serious public health threat.”

Mr Mulligan said all employees and facilities would be retained. In a statement, Daniel J. AbdunNabi, chief executive of Emergent BioSolutions, said the acquisition of Adapt Pharma was directly linked to its mission to protect and enhance life. "By leveraging Emergent’s core competencies and 20-year track record as a trusted partner to

The deal, worth about ¤540 million, is expected to close before the end of the year. Narcan became available in the US in 2016 and is the first and only needle-free formulation of naloxone approved by the US Food and Drug Administration. It is distributed to health agencies, first responders and retail pharmacies. The US government has declared the opioid crisis a public health emergency and has identified overdose-reversing drugs, such as Narcan, as one of the strategies to fight the epidemic.


Feature Good practice at the counter the role of the pharmacist in treating hyperhidrosis or excessive sweating Sweating is a natural bodily function that helps us regulate our body temperature. But for millions of people around the world excessive sweating can be a cause of shame and embarrassment. The condition, known as hyperhidrosis, involves an over activity of the body’s cooling mechanism. While no figures exist for how many people are affected by hyperhidrosis in Ireland, it is estimated to affect around half a million people in the UK or 5% of the population worldwide. Sweating and hyperhidrosis expert Dr. David O’ Connell says: ‘Excess sweating can have a really negative impact on a person’s sense of wellbeing and how they live their life. It can affect interpersonal relationships, work productivity and leisure activities. We’ve seen patients taking all sorts of extraordinary measures to avoid others noticing, such as buying and carrying multiple changes of the same type of clothes with them.’ Causes of Hyperhidrosis While the exact cause of excess sweating is unclear, the mechanism involves over-activity in the sympathetic nervous system, specifically the thoracic sympathetic chain. This neural network controls apocrine and eccrine glands throughout the body causing hyperstimulation in any given area which leads to excess secretions. Wearing non-breathable clothing and other lifestyle factors such as alcohol and caffeine have also been shown to stimulate sweat production. How to identify the problem among patients Excessive sweating usually occurs in specific areas of the body. For example, hand sweating can be a typical area that produces problems with holding objects, turning door knobs, opening jars, working with hand tools and writing on paper. A recent study also highlighted problems experienced by patients when using touch technologies, such as computer keyboards, mobile phones, computer mouse and touch screen devices. However, hyperhidrosis can occur anywhere on the body. Some of the more common areas include: Armpit Sweating – also described as sweaty armpits Hand Sweating – also described as sweaty hands, clammy hands, moist hands

Hyperhidrosis involves an over activity of the body’s cooling mechanism

Feet Sweating – also described as sweaty feet, clammy feet, moist feet Facial Sweating – also described as sweaty face, blushing, facial blushing Two types of Hyperhidrosis When excessive sweating is localised (e.g. palms, soles, face, underarms, scalp) it is referred to as primary hyperhidrosis and there is no known cause. In Dr. O’Connell’s experience there is often a family history of the problem and it tends to develop first in adolescence. ‘The key issue is to establish and confirm that there is no underlying medical cause or medication which is responsible’ he says. Primary hyperhidrosis tends not to occur while patients are sleeping. Secondary hyperhidrosis occurs where the sweating is more generalised and begins further into adulthood. The cause is more likely

to be due to an underlying medical condition or as a side effect of medication. This type of sweating will usually occur at night also. Dr. O’Connell advises: ‘There is a long list of potential causes of secondary hyperhidrosis, most of which fall into the categories of endocrine or neurological. More common causes would include obesity, hyperthyroidism or menopause. The list of medications potentially causing hyperhidrosis is also long but includes SSRI’s, anti-hypertensives such as amlodipine and lisinopril, anti-histamines such as loratadine, NSAIDs e.g. naproxen and some PPI’s.’ How the Pharmacy team can help The pharmacy will often be the first port of call for people suffering from hyperhidrosis but according to Dr O’Connell, it’s not always an easy conversation for the

patient to have. ‘Hyperhidrosis can seriously impact a person’s self confidence, so it’s important to be sensitive and reassuring when discussing the topic. You want the person to be as open and honest as possible about their symptoms and the lifestyle triggers that may exacerbate them.’ 4 Steps to good Pharmacy practice Step 1. Find a quiet space or take the patient to the consultation room A person who suffers from excessive sweating may be embarrassed to approach the counter when others are around. They may request somewhere more private to talk, or advise that they wish to speak with the pharmacist. Ensure that you and your team are prepared to be approached in this way and be as discreet as possible.

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Feature Step 2. Advise on lifestyle changes There may be simple lifestyle changes that the patient can make in order to minimise the triggers of excessive sweating. The pharmacy team can help the patient identify these triggers by encouraging them to be as open as possible about their lifestyle. Simple steps the patient can take include: • Wearing lighter clothing • Drinking less alcohol or caffeine (but only if they are over drinking) • Minimising hurry and rushing about •

Counselling or hypnotherapy to help overcome stressful situations that may be contributing to the problem.

depending on levels of irritation caused. Antiperspirant products such as the Perspirex range, contain aluminium chloride, a key ingredient in the reduction of the affects of hyperhidrosis. When applied to clean, dry, unbroken skin at night, it can provide relief for up to five days by forming salts to cause obstruction to the distal sweat gland ducts. There has been controversy in the past around potential side effects of aluminium chloride use, however neither the EU medical regulatory body nor the FDA recognise causal links in this regard. Antiperspirants can also be applied to patients’ hands and feet. There is some evidence to show that with continued use of antiperspirants over time sweat gland activity is reduced. Figures typically show 80-90% of patients reporting satisfactory outcomes with this method.1

Step 3.

Step 4.

Advise on efficacy of antiperspirants

Refer to a gp for other types of treatment

Extra effective antiperspirants are usually the first line of treatment for patients suffering from axillary hyperhidrosis, although they can be used in other sites also

If extra effective antiperspirants aren’t sufficient in providing relief, the next line of treatment is to refer the patient to their GP for further consultation.

Specialist treatment can include: • Iontophoresis This treatment has been shown to be effective around 85% of the time. It entails use of a dedicated device to safely pass low voltage electrical current through the skin of the hands and feet which are immersed in trays of water. There are also means of delivering this treatment to the underarms. The exact mechanism of how iontophoresis works is not fully understood but seems to again entail blockage of the gland ducts via ion formation. Treatment requires roughly seven sessions over a four week period initially to get sweating under control and thereafter, top-up treatments are performed every one to two weeks. The disadvantage of this mode of treatment is the cost of machines which must be purchased by patients and also its time-consuming nature with each session taking about 20-30 minutes. There are also considerations around uses with soft vs. hard water. • Localised surgical treatments While localised surgical treatments are also available, along with

more invasive procedures such as thoracic sympathectomy, these are more rarely performed and preferably avoided where possible. • Botox injections The next treatment modality frequently offered to patients is intradermal injection of botulinum toxin which functions by blocking neurotransmitters which activate sweat glands. Multiple near painless injections with a fine needle are made in the axilla which tend to result in a dramatic reduction in sweat gland activity (80-90%) over a period of 4-10 months. This procedure is performed without anaesthetic and takes roughly 10-15 minutes only. Botilinum toxin can also be used to treat palmar hyperhidrosis, however given the thick skin and level of nerve endings in the area this can be painful and is not routinely performed. Botulinum toxin is not currently licensed for treating hyperhidrosis of the feet but can be used off licence. 1 Treatment Options for Hyperhidrosis. Hobart W. Walling1 and Brian L. Swick2. Am J Clin Dermatol 2011; 12 (5): 1-11

News Sheridan's Pharmacy gives back to community with annual fundraiser Sheridan’s Pharmacy Roselawn recently held their annual community fundraising event in aid of an important local charity, A Little Lifetime Foundation. Des Sheridan is a pharmacist and the proprietor of the store. is and why it is important they are very willing to give. There is a great community spirit around here. That’s what it’s all about: giving a personal service to the customers, being part of the community, and giving back to the community.”

Deirdre Kelly, Sheridan's Pharmacy and customer Anne Purtill “With this fundraiser we are giving back to the community and the particular charity we selected provides a free counselling service to bereaved parents whose child has passed away during pregnancy, childbirth or shortly after birth. People around here are very generous so once you explain to them what the charity

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On offer that day were cakes for sale, goody bags, free hand massages and free blood pressure checks. Local traders, suppliers and residents from the area donated items for raffle prizes and the final sum raised was an impressive ¤3250. Jessica Melia is the manager of Sheridan’s Pharmacy. “The day was a massive success. A huge thank you to all our customers for their continued support with these fundraising days and also a huge thank you to the team in A Little Lifetime for coming in on our special day and supporting us in our quest to spread awareness for the support that is out there for bereaved parents.”

Melia explained to Irish Pharmacy News why the team plan these types of events. “We run one big charity event every year. The main thing we aim for with these events is to create awareness for the work the particular charity does for bereaved parents in the wider community. The second thing is to raise funds to help them to keep doing this important work and the third thing and how it works from our point of view is that we get to reach people who maybe before were not aware of us. Last year we held the fundraiser in aid of Our Lady's Children's Hospital, Crumlin and we did notice an increase in new scripts afterwards because we were outside the store having tea and coffee with people we wouldn’t necessarily know or recognise and we were also providing free blood pressure checks so that is another way we can give back to the community while also adding value to the business.”

Mary McGrath is the volunteer chairperson of A Little Lifetime Foundation, which is based in Blanchardstown. McGrath told IPN that she was “amazed” by the amount of money raised by the team at Sheridan’s. “It’s an incredible amount of money and we are extremely grateful. What also means a lot to us is the fact that the event raised awareness and that is really important for a small charity like ours. There are a lot of young families living in Blanchardstown so we want people who are grieving the loss of a child, at any stage of pregnancy or during or after birth, to know that we are here and we are open and we want to help. We are just so pleased to have been selected and very grateful to Des and to Jessica and to the whole team.” More information on the charity and the services it provides, which includes one-to-one counselling, can be found by visiting https://alittlelifetime.ie


News Irish Thoracic Society calls for appropriate staffing and resourcing of centres of expertise for all patients with lung fibrosis in Ireland A new patient registry for people living with idiopathic pulmonary fibrosis (IPF) was launched recently by the Irish Thoracic Society and the Minister of State for Health Promotion, Catherine Byrne, TD. The Irish Thoracic Society, which is the national organisation of healthcare professionals caring for people with lung disease in Ireland, has developed the disease registry and accompanying position statement to shine a light on the need for appropriately-staffed specialist centres and effective treatments for people living with IPF. Suzanne McCormack, CEO of the Irish Thoracic Society, told Irish Pharmacy News that the purpose of the registry is to generate data on the "causes, prevalence, incidence, treatment and the long-term prognosis of lung fibrosis in Ireland" and to "provide guidance on the best diagnostic and care pathways". The ultimate aim of the registry is to inform policy-makers on which resources are required in order to make this possible in communities throughout Ireland. The position paper also sets out the standards required to ensure "that all patients with lung fibrosis have equitable access to diagnosis and management in line with international guidelines and best practice." Suzanne McCormack continued: "Idiopathic Pulmonary Fibrosis, or IPF, is the most common form of lung fibrosis and is both chronic and progressive, resulting in severe morbidity. Based on UK prevalence, it is estimated that there are approximately 1,000 people in Ireland with the disease, with around 400 new cases diagnosed each year. IPF has a mortality rate worse than most forms of cancer and evidence suggests that survival with IPF in Ireland is below the EU average." Professor Anthony O'Regan is a Consultant Respiratory Physician. He believes that patients depend on the hope of new therapies being developed. "Until relatively recently the lack of effective diagnosis and treatment options for lung fibrosis, meant it was the 'Cinderella' of respiratory diseases. However, the world of treating lung fibrosis has changed dramatically over the past decade thanks to novel therapies and an

increase in the rate of successful lung transplants. These developments have brought real hope to patients, making early diagnosis and rapid referral to treatment more crucial than ever. Unfortunately, as lung fibrosis progresses, patients' needs become more complex and multi-faceted. "Consequently, we must be able to respond quickly with access to appropriate medical, physiotherapy, nutritional, psychological, social and palliative supports, as well as information on accessing lung transplantation where appropriate. It is incumbent on the health service to act urgently to resource all centres of expertise in lung fibrosis to the required standards. This should be achieved in tandem with the development of a National Clinical Programme on lung fibrosis to reflect how seriously we take this disease. Only then will patients reap the benefits of a standard pathway of care and access to novel treatments in a way that is fair, equitable and timely." The Irish Thoracic Society wants the specialist centres of expertise in lung fibrosis to be resourced with multi-disciplinary teams and for the centres to be structured in such a way as to ensure fair and equitable access for all patients, regardless of their location. It also wants all patients suspected of having lung fibrosis to be diagnosed and treated within 16 weeks and has identified "significant deficits in terms of resources" in centres servicing patients with IPF. The Society wants the specialised multidisciplinary teams to include: - A respiratory consultant with a special interest in lung fibrosis. - Lung fibrosis specialist nurse (circa. 1 per 50 patients). - Specialist respiratory physiotherapist with an interest in lung fibrosis. - Access to thoracic surgery, rheumatology, palliative care, medical social worker, psychological and nutritional supports.

David Crosby, double lung transplant recipient, Simone Feresin, Roche Ireland, Professor Ross Morgan, President, Irish Thoracic Society, Catherine Byrne TD, Minister of State, Department of Health, Professor Anthony O'Regan, Consultant Respiratory Physician, University Hospital Galway, Lindsay Brown, clinical nurse specialist, St Vincent's University Hospital Dublin, and John Barron, Boehringer Ingelheim, pictured at the launch of a new national patient registry and position statement on the management of lung fibrosis by the Irish Thoracic Society.


News Researchers find a marker which can identify patients who would benefit from novel asthma treatments Researchers at RCSI, Stanford University and Oregon Health Sciences University have discovered a marker which can help determine which asthma patients are likely to benefit from a new treatment which targets inflammatory cells called Eosinophils. The research, which was funded through a Health Research Board Clinician Scientist Award, has been published in Science Translational Medicine. Asthma is a common clinical condition characterised by airway obstruction, inflammation, and hyper responsiveness. It affects approximately 470,000 people in Ireland. Symptoms such as bronchoconstriction and cough range from mild intermittent to severe persistent. Some patients, despite good treatment, remain troubled by the symptoms of their condition. According to Professor Richard Costello, Department of Medicine, RCSI, “The novel treatments now available for asthma present a new challenge for clinicians. It is important that we are able to identify which patient will benefit from these treatments. Our research set out to determine if there were any particular markers which would help us to understand which patients had a particular form of asthma and would respond well to new treatments”. Professor Costello explained that in eosinophilic asthma, the most common form of asthma, inflammatory cells (eosinophils) in

the airway alter nerve function and make the condition worse. “We identified that inflammatory cells, in particular, eosinophils, promote airway nerve growth in patients with asthma. These observations provide a unique insight into a fundamental mechanism of how the inflammation caused by asthma causes people to experience the symptoms of asthma such as coughing and breathlessness”, said Professor Costello. “Our research means that we now know which markers to look for in a patient with severe asthma. A patient with markers which show they have this particular form of asthma is likely to respond well to these new treatments”. RCSI is an international notfor-profit health sciences institution, founded in 1784, with its headquarters in Dublin. It is focused on education and research to drive improvements in human health worldwide. It is ranked among the top 250 (top 2%) of

Professor Richard Costello, Department of Medicine, RCSI

universities worldwide in the Times Higher Education World University Rankings (2018) and its research is ranked first in Ireland for citations. It is a signatory of the Athena SWAN Charter.

Boots Ireland have launched their first Irish-shot beauty campaign, celebrating the ladies of Ireland in their new “It’s How it Makes you Feel” campaign.

The film by Ogilvy Dublin shines a light on how beauty provides a platform for expression for all ages and stages of life. Running through scenarios familiar to many women of Ireland, we see the hurried beauty routine while a taxi meter ticks on, ready to carry a group of friends away for a night on the tiles. We see ‘perfect selfie’ preening, an appreciative nod to the tan-applying partners of Ireland, and the little white lies that promises ‘’I’m literally leaving the house right now’’ I swear! Finally, the advert calls on the ladies of Ireland to ‘keep doing

what you’re doing’ to keep embracing the freedom of expression that beauty allows. A celebration of modern-day beauty, the campaign also alludes to the feelings evoked by beauty routines, how perfectly winged eyeliner can set you up for the day, a sparkly eye palette kickstarts the party mood, and how luxurious skincare can be just the pick-me-up a rainy day requires. Offering amongst the widest range of beauty products in Ireland, from high street favourites to premium brands and Boots exclusives, Boots Ireland provides everyone with the opportunity to express themselves and experience the joyful liberation of how beauty makes them feel, every day. Commenting on about the launch of the campaign, Gillian Hennessy, Head of Marketing, Boots Ireland said: “Our vision for

IPSEN ANNOUNCES GM FOR IRELAND AND THE UK French pharmaceutical company Ipsen has appointed a new general manager for its Ireland and UK office. Asad Mohsin Ali joins Ipsen from his former role as vice president and general manager for the UK, Ireland and Nordics at Tesaro. After more than two decades driving innovation and commercial growth across the pharmaceutical industry, Mr Ali will lead Ipsen’s growing commercial presence in Ireland and the UK. “I am delighted to be joining an exceptional Ipsen team,” Mr Ali said.

Boots Ireland launches first ever Irish-shot beauty advertising campaign Launched in Ireland across TV, social and video on demand, the campaign celebrates the role that beauty plays in bringing moments of joy to everyday life in Ireland, and highlights how beauty is in fact less about how you look, and more about how it makes you feel.

news brief

this campaign was to champion Irish women’s right to embrace feeling good through beauty and to remind ourselves that beauty is a celebration of feeling fantastic. We are passionate believers that beauty is for everyone. Embracing beauty at Boots means showcasing your individuality and spirit and we hope this new campaign is a reminder to celebrate your right to feel good!” Ogilvy Dublin is one of the largest marketing communications networks in Ireland. Ogilvy is a collective of passionate, innovative thinkers, working collaboratively within a wider group of like-minded companies, to bring to light a shared vision of making brands matter. “It’s How it Makes You Feel” campaign was created by award-winning team, Emma Fielding and Marcus Hartung. The film is directed by Zak Emerson, known for his direction on award-winning commercials.

“We have real potential to build on our UK and Ireland footprint over the coming years and my desire is that we create a true global hub for innovation across this region.” Harout Semerjian, executive vice president and Ipsen’s chief commercial officer, said Mr Ali had demonstrated strong leadership skills and was motivated to exceed his stakeholders’ expectations.

BANNED E-CIGARETTE LIQUIDS AVAILABLE IN IRELAND The United States has banned online shops from selling nicotine-containing e-liquids with labels that appeal to children, but in Ireland the same products continue to be sold. The US Food and Drug Administration said 17 companies had stopped selling liquids with labelling or advertising that resembled child-friendly food products. In Ireland, some of the products banned for sale by the FDA are available for sale. They include products that are marketed to look like confectionary and dairy whipping topping. “Removing these products from the market was a critical step toward protecting our kids,” FDA commissioner Scott Gottlieb said. “When companies market these products using imagery that misleads a child into thinking they’re things they’ve consumed before, like a juice box or candy, that can create an imminent risk of harm to a child who may confuse the product for something safe and familiar.”

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Clinical Profiles NEW LIXIANA® (EDOXABAN) PACKAGING PROMOTES ADHERENCE, HELPING TO SECURE LONG-TERM BENEFITS FOR PATIENTS

which do not treat active symptoms. Other barriers to adherence can include experiencing unwanted side-effects from medications, or difficulties with following complex treatment regimens or multiple treatment regimens.

Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo), has announced the launch of new packaging for edoxaban (known by the brand name LIXIANA®), to help improve pill-taking routines and adherence in real-life settings. Edoxaban is the only once-daily NOAC with superior reduction in major bleeding compared to well managed warfarin in non-valvular atrial fibrillation (NVAF).2 The safety profile of edoxaban has been established in a broad range of patients in the ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation) study, who were followed for an average of 2.8 years.2

“We, at Daiichi Sankyo, are committed to patient safety as our highest priority; one important aspect of this is ensuring patients are supported in adhering to their treatment regimen,” said Benoit Creveau, Head of Marketing Cardiovascular, Daiichi Sankyo Europe. “We want to enable and empower patients to take control of their long-term care to ensure that they derive maximum benefit from their treatment, resulting in fewer emergency events and hospitalisations.”

Real world data has shown that more than one in four AF patients have suboptimal adherence to NOACs, increasing their risk of stroke and death, when compared to those with optimal adherence.3 More broadly, it has been shown that poor adherence to oral treatments in chronic conditions leads to worse patient outcomes and higher hospitalisation rates compared to those who take medication as prescribed.4,5 Medication adherence is therefore of vital importance and research has shown that packaging interventions can be one way to effectively increase this.6 The newly launched edoxaban packaging has been designed to include multiple features to improve medication adherence. The pack features a reminder message and intake timer on the inside cover of the top-opening pack, reminding patients what time of day to take their medication, which has been shown to have a positive effect on adherence,7 and could be particularly helpful for newly diagnosed or forgetful patients. For patients who have switched from a vitamin K antagonist (VKA), the new packaging helps to reinforce the importance of compliance and avoiding complacency with a new regimen that may be considered less demanding. A last blister-pack message on the inside of the bottom of the pack reminds patients that it is time to renew their prescription; encouraging regular contact with their doctor and improving longterm pack-to-pack adherence. Furthermore, a QR code printed on the inside cover of the pack allows patients easy access to the patient leaflet in digital format and the easy-opening packaging has been designed to help patients with reduced finger dexterity. Patient adherence to medication is a complex issue and personal characteristics can act as barriers to treatment. It can be challenging for patients to adhere to medications

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For patients starting anticoagulant treatment, medication ease of use or convenience supports adherence and establishes a strong routine for taking treatment as prescribed. AF patients identified the factors that can improve medication convenience include easy-open packaging and packs that include dosing reminders, for example day and time labels. Patients with AF also prefer easyto-administer therapies, specifically once-daily dosing is preferable to twice-daily dosing. If real-life adherence levels are more closely aligned with the adherence levels seen in clinical trials, physicians can feel confident that their patients will benefit from edoxaban as expected.

HELP AT HAND FOR PEOPLE WHO FIND CYSTITIS AND UTI’S DIFFICULT TO TALK ABOUT Cystitis is a very common condition affecting one in two women. It is more common among females than males because women have shorter urethras. Cystitis is a fairly common urinary tract infection or inflammation of the bladder. It is an inflammatory response to the adhesion of bacteria to the surface of the bladder and urethral which are normally sterile. The bacteria fasten to the lining of the bladder and cause the area to become irritated and inflamed. Although not normally a serious condition it can be uncomfortable and lead to complications if left untreated. The infection can cause various symptoms, which include a frequent urge to urinate, pain when urinating and pressure in the lower back or pelvis. Many women who have never suffered from cystitis find that they have frequent bouts of infection during pregnancy. Sexually active women have a higher risk of bacteria entering via the urethra and one of the reasons why cystitis is particularly common among sexually active post menopausal women is that there is insufficient lubrication of the vaginal canal during intercourse, the result may be friction and damage to the urethral passage and the bladder which may lead to cystitis. The

hormone oestrogen is responsible for providing the natural lubrication found in the vagina and there is a gradual reduction in oestrogen after the menopause. Poor toilet hygiene habits can be a factor, and insufficient emptying of the bladder another. Symptoms can include the feeling that you need to urinate more often and suffering from uncomfortable or even painful urination, traces of blood in the urine, dark, cloudy or strong smelling urine, A burning or stinging sensation when you urinate can be a symptom of cystitis. The frequent need to urinate is another. Advice to avoid cystitis would be to drink plenty of water, to avoid caffeinated, alcoholic and fizzy drinks, to avoid perfumed soaps, shower and bath products and vaginal deodorants, to wear cotton underwear and avoid wearing tight trousers, to pass urine when you feel the urge rather than trying to hold on until later making sure to empty the bladder completely. Most cases of mild cystitis will resolve itself within a few days. A brand new formulation, now available from Arkopharma, global leaders in natural treatments, is CYS-CONTROL which is a complete effective and natural treatment for recurring cystitis due to the synergistic action of Cranberry and D-Mannose on E.Coli. D-Mannose is a simple sugar. It is especially common in fruits such as apples, peaches, organs, mangoes, lychees and in certain berries such as cranberries. Thanks to its molecular structure, D-Mannose can attach to the type 1pili located on the surface of certain bacterias such as E. coli. This in turn hinders the attachment of the bacteria to the walls of the urinary system. Once this initial adhesion had been prevented, the bacteria cannot cause infection. The D-Mannose Bateria Complex is eliminated through urination and this is facilitated through the heather extract. D-Mannose can be used by adults, pregnant/breastfeeding women and children. CYS-CONTROL PLUS RRP ¤19.95 - Available in pharmacies nationwide.

ACCORD LAUNCH BUPIVACAINE HYDROCHLORIDE 2.5 MG/ ML AND 5 MG/ML SOLUTION FOR INJECTION Accord Healthcare is delighted to announce the launch of Bupivacaine Hydrochloride 2.5 mg/ml and 5 mg/ ml Solution for Injection in packs of 5 ampoules. This medicine is indicated for: • Surgical anaesthesia in adults and children above 12 years of age • Acute pain management in adults, infants and children above 1 year of age. • Production of prolonged local anaesthesia by percutaneous infiltration, intra-articular block,

peripheral nerve block(s) and central neural block (caudal or epidural). • Pain relief during labour. Please refer to the Summary of Product Characteristics (SPC) available at www.hpra.ie or for Healthcare Professionals at www.accord-healthcare.ie for further information. For further information please contact Accord in Cork on 021-461 9040 or visit www.accord-healthcare.ie

NUVAIRA ANNOUNCES ORAL PRESENTATION AT ERS INTERNATIONAL CONGRESS DISCUSSING SIGNIFICANCE OF TARGETED LUNG DENERVATION TO TREAT COPD Nuvaira, a developer of medical devices to treat obstructive lung diseases, announced the acceptance of a clinical abstract by the European Respiratory Society (ERS) for oral presentation at the 28th International Congress 2018 in Paris. Co-principal Investigator, Dirk-Jan Slebos, M.D., Ph.D., from the University Medical Center Groningen in the Netherlands, today will make the first public presentation of results from the AIRFLOW-2 clinical trial (NCT#02058459), the first multi-center, double-blind, randomised, sham-controlled study of Targeted Lung Denervation (TLD) using the Nuvaira™ Lung Denervation System to treat patients with moderate to severe COPD. “Results from this phase II trial demonstrate a significant reduction in respiratory adverse events such as COPD exacerbations and hospitalizations of greater than 50 percent,” said Dr. Slebos. “I believe these results may have important implications for COPD sufferers and their overall quality of life, as well as for healthcare costs, as there is significant expense associated with exacerbations and hospitalizations. “TLD is a one-time medical procedure, and it’s the first to target the whole lung by bronchoscopically disrupting parasympathetic nerves to promote airway dilation to make it easier for patients to breathe,” continued Dr. Slebos. “This novel lung denervation system may offer patients who suffer from COPD a long-term treatment that has added effect on top of medical management.” The oral presentation entitled, “A double-blind, randomized, sham-controlled study of Targeted Lung Denervation in patients with moderate to severe COPD,” by Dr. Slebos et al., takes place today at 15:00 CEST in room 7.3Z2 as part of the session on “Interventional pulmonology highlights in 2018: ELVR, TLD and BT” (Session 496, Abstract no. OA4929) at the Paris Expo Porte de Versailles.


PROUDLY SUPPORTING MUNSTER RUGBY

Freephone: 1800 307777

Freefax: 1800 313395

Email: pharmacy@flemingmedical.ie

Physiologix Sports Supports - Supporting Munster Rugby all the way Limerick based Fleming Medical has teamed up with Munster Rugby as their official Medical Supplies partner in a recently signed three-year deal. The Physiologix range belongs to a stable of brands from Fleming Medical which also includes Medicare, Irelands No. 1 pharmacy only First Aid brand. The partnership includes the naming of the Physiologix Treatment Room in the Munster Rugby High Performance Centre at the University of Limerick.

Munster rugby players Doug Howlett, Tadhg Beirne, Damien Mordan, Jean Kleyn and Calvin Nash with Mark Fleming, MD of Fleming Medical

Founded by CEO, Mark Fleming 30 years ago in Limerick, Fleming Medical now employs more than 60 people and is a trusted partner for Irish and international pharmacists and healthcare providers in the delivery of quality healthcare products. The range of tapes & supports is Munster Rugby’s choice for more severe and permanent injuries or injuries with reduced function. Each Physiologix product has been developed & designed to provide firm support that enables effective stabilisation & effective compression for the user. To launch the partnership Munster Players Tadhg Beirne,

Jean Kleyn & Limerick native Calvin Nash joined Mark Fleming MD of Fleming & Doug Howlett from Munster Rugby in the new Physiologix Treatment Room Commenting on the partnership Head of Commercial and Marketing, Doug Howlett said, “We are delighted to welcome Medicare/ Physiologix as a new partner. It’s always great to work

with a local business that we can support in achieving their international growth aspirations.” Damien Mordan, Munster Rugby Lead Physiotherapist who has been involved in each stage of the product development process said, “I believe the standard of materials, design & technology is excellent in the Physiologix range, my Physio team and I are using

them both on and off the pitch daily for the Munster team.” Mark Fleming, MD Fleming Medical said, “The products in our Physiologix range are based on our most advanced designs & materials to date. Being a proud Munster company with Munster in our DNA, we are delighted to partner with Munster Rugby as their Medical Supplies Partner.”

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CELEBRATING HEROES IN OUR COMMUNITIES CarePlus are proud sponsors of the CarePlus Family Carer of the Year & Young Carer of the Year Awards 2018.

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