In this issue: NEWS: PIER AGM elects new committee - PROFILE: Taking pharmacy back to the basics with Noeleen Harvey - REPORT: Value of the pharmaceutical industry in Ireland - FEATURE: Vitamins, minerals and supplements - CPD: Pharmacy management of Epilepsy - AWARDS: Launch of the 2015 Irish Pharmacy Awards - OUT AND ABOUT: Coverage of the IACPT Annual Meeting
Volume 7 Issue 1 THE INDEPENDENT VOICE OF PHARMACY In this issue: NEWS: PIER AGM elects new committee Page 5 PROFILE: Taking pharmacy back to the basics with Noeleen Harvey Page 9 REPORT: Value of the pharmaceutical industry in Ireland Page 16 FEATURE: Vitamins, minerals and supplements Page 21 CPD: Pharmacy management of Epilepsy Page 31 AWARDS: Launch of the 2015 Irish Pharmacy Awards Page 36 OUT AND ABOUT: Coverage of the IACPT Annual Meeting Page 56 Shortlisted BUSINESS TO BUSINESS MAGAZINE OF THE YEAR Your pharmacy partner for 2015 Please contact your Unilever Representative
Transcript
Volume 7 Issue 1
THE INDEPENDENT VOICE OF PHARMACY
In this issue: NEWS:PIER AGM elects new committee Page 5
PROFILE:Taking pharmacy back to the basics with Noeleen Harvey Page 9
REPORT:Value of the pharmaceutical industry in Ireland Page 16
FEATURE: Vitamins, minerals and supplements Page 21
CPD: Pharmacy management of Epilepsy Page 31
AWARDS: Launch of the 2015 Irish Pharmacy Awards Page 36
OUT AND ABOUT:Coverage of the IACPT Annual Meeting Page 56
Shortlisted BUSINESS TO BUSINESS MAGAZINE OF THE YEAR
For more information on any of our products please contact [email protected]
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ForewordContents
Irish Pharmacy News is circulated to all independent, multiple and hospital pharmacist, government offi cials and departments, pharmacy managers, manufactures and wholesalers. Buyers of pharmacy groups and healthcare outlets. Circulation is free to all pharmacists subscription rate for Irish Pharmacy News ¤60 plus vat per year.
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 of transmitted in any form without written permission. IPN Communications Ltd. have 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.
IRISH PHARMACY NEWS
Page 4Pharmacy programme to take new students in September
Page 9Taking pharmacy back to the basics with Noeleen Harvey
Page 12eScript pilot launches in Cork
Page 36Launch of the 2015 Irish Pharmacy Awards
Page 58School of Pharmacy Prize-givings
What will the year 2015 bring to Pharmacy?
Unfortunately, the outlook is none too bright. Everyone knows the value of their local pharmacist apart, it would seem, from many of the Governments within the EU. They really are missing a trick or two by not allowing them to become more involved with the community in which they serve, including being able to offer additional services and medication.
Those pharmacists, who are consulted by their patients (before going to see the doctor) are often in the very best position to prevent State coffers being exhaustively spent on a complaint which, later turns into a more complicated illness. Pharmacists, by their very profession, are taught to recognise warning signs and to recommend that patients should pay a visit to the doctor, when necessary, rather than wait and let things go from bad to worse.
There are so many other areas where the authorities could better use a pharmacy’s facilities and everyone’s New Year Resolution in Pharmacy should be that the IPU starts to make inroads in its current discussions with the new Minister for Health for the benefi t of the Irish public, as well as its own members.
The news is not good in other areas either, such as pharmacy retail sales. Also, the development of new drugs is changing dramatically.
Many pharmacists do need to keep up with modern trends and be prepared to adapt in order for them to remain in a healthy situation.
IPN’s resolution is to bring as many of these as possible to the attention of its readers.
The Irish Pharmacy Awards
The IPN Annual Awards will be held on May 23rd this year. All IPN readers play an extremely important part in these Awards because, without their nominations, they could not take place. IPN would like to thank all those who put forward nominations in the past and is looking forward to receiving plenty more nominations when the time comes round again.
CONTRIBUTORS Anne StauntonDr Brendan FitzpatrickDr Daniel McCartney
ART DIRECTOR - Smart Page Design
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4
news briefIRISH RESEARCHERS WIN EU GRANTS The European Research Council (ERC) has selected 328 first class scientists to receive its prestigious Starting Grants, worth up to ¤2 million each – 8 of these scientists are based in Ireland.
The awarded ¤485 million contributes to supporting a new generation of top scientists in Europe developing so-called "blue sky research": ambitious high-risk, high-gain research projects in any field.
The recipients based in Ireland are:
• Mark Ahearne, Trinity College Dublin
• Eilionóir Flynn, National University of Ireland, Galway
• Suzanne Kingston, University College Dublin
• Caitríona Lally, Dublin City University
• Sarah McCormack, Trinity College Dublin
• Redmond O'Connell, Trinity College Dublin
• Martin O'Donnell, National University of Ireland, Galway
• Thomas Reed, University College Cork
The projects selected cover a wide array of topics, including wearable electronic textiles powered by body heat, detection of bacteria by smell, 'toxic expertise' in the petrochemical industry, the origins of human rationality, combatting cancer related inflammation, as well as optimising user interface design.
Dr. Caitríona Lally from Dublin City University has won funding for her project entitled: 'Frontier research in arterial fibre remodelling for vascular disease diagnosis and tissue engineering (FibreRemodel)'. Caitríona said on hearing the news about her award, "I am really delighted to have been awarded this prestigious grant. I am excited about the opportunities that this significant funding now affords me over the next 5 years to consolidate my research and realise the full translational benefit of my work".
NewsNew Pharmacy Programme to take first pharmacy students next September
Leonie Clarke, PSI President, said the new programme was intended to keep pace with changing healthcare needs in Ireland and offer an improved student experience through its evidence-based and experiential-based learning approach.
“The PSI is delighted to officially launch this new, integrated programme of education and training for students of pharmacy in Ireland. It represents significant progression in the way we train the pharmacists of the future to meet the evolving needs of a changing healthcare system. The revamped integrated training will mean all students will have the opportunity to gain experience in community, hospital and industrial pharmacy, offering insights into various practice settings and enhanced career opportunities. Students will also be able to undertake some of their placements abroad.
“The new framework will facilitate a greater contribution from pharmacists to the Irish health system and promote greater access for the profession to the very successful pharmaceutical industry,” added Clarke.
The new five-year integrated Master’s degree programme will allow for real life practice exposure throughout the five year course for pharmacy students, with the format previously a ‘4+1’ model with formal mandatory training designated only in the fifth year. The programme will see its first
intake of students next September 2015, with the first graduates from the programme commencing practice in 2020.
All students will have opportunities for immersion in the three main pharmacy practice settings during their training, with a greater emphasis on industry experience in particular to enhance students’ experiences and broaden their horizons. Integration of the theoretical and practice learning opportunities will enhance the preparation of pharmacists to contribute to patient care and understand the needs of the health system by having a more rounded ‘whole system’ understanding of pharmacy practice across the diversity of settings in which pharmacy is practised, and should enhance career opportunities for students once qualified.
Educational reform has been a priority of the PSI Council
since its formation in 2007. The Pharmacy Act 2007 conferred significant functions on the PSI in relation to the education and training of pharmacists, from accreditation of undergraduate pharmacy education and training, to the continuing professional development (CPD) of pharmacists post-registration.
The last decade has seen significant change for pharmacy in Ireland. The Pharmacy Act 2007 established a new regulatory environment that underpins the safe provision of pharmacy services and that has been the foundation for the expansion of pharmacy services and a more integrated role for pharmacists in our health service.
To learn more about the new programme, visit: http://www.thepsi.ie/gns/education/overview.aspx
The Minister for Health, Leo Varadkar TD, with the Pharmaceutical Society of Ireland (PSI), the pharmacy regulator, has launched a new five-year integrated Master’s degree programme in pharmacy which will enable future pharmacists to better meet the changing needs of the healthcare system in Ireland.
Minister for Health, Leo Varadkar TD, with Leonie Clarke, PSI President
The following people were also elected to serve on the Committee:
Dr Brendan Griffin (UCC School of Pharmacy) was re-elected as Treasurer.
Dr Maura Kinahan (BioInnovate) and Dr Catherine McHugh (Paraxel) were both re-elected for a second term.
Cathal Gallagher (J&J Ethicon), Michael Lennon (HPRA) and Jenny Loughney (PharmaChemical Ireland) have joined as new
New PIER Committee elected at AGMPharmacists in Industry, Education and Regulation (PIER) elected a new Committee at its recent AGM. The new Chair is Gwynne Morley (Uniphar Retail Services) and Helen Naddy (Mallinckrodt) was elected as PIER Secretary.
committee members and David Carroll (PEI Surgical) was not due for re-election but remains on the Committee.
This year, 2014 has been a very active and successful one for the group with three career events being organised for those undergraduates and graduates, who are interested in careers in the wider industry. Over 200 people attended each of these events.
Alongside the career events, PIER also organised two CPD
events to support ongoing CPD for members. They were ‘The Biologics Landscape’ in April and, in November a meeting was also held on the Medical Device Industry.
PIER would welcome any pharmacists in community or hospital pharmacy, who may like to attend a PIER meeting or event or who may be considering a change in career direction to join the organisation. Further details available from www.pier.ie
5
news briefMORE FUNDS NEEDED FOR DIABETES CARE
Type II diabetes is becoming more prevalent in Irish society with this chronic disease currently affecting up to five per cent of the population.
Irish pharmacists are now more than ever seeing increased rates of patients in their pharmacies who require ongoing medical help to maintain and change their lifestyle after being diagnosed with Type II diabetes.
An integrated model of care where the majority of patients with Type II diabetes are seen three times a year by their GPs and practice nurses with back-up support from community based diabetes nurses and community based pharmacists has long been accepted as the best model of care however this is not necessarily the way patients are receiving treatment. Currently many Irish patients with Type II diabetes face long waiting lists to see endocrinologists in hospitals.
Many pharmacists and GPs are now speaking out against the lack of funding when it comes to diabetes care in the community.
Dr Velma Harkins, a midlands GP said, “We know it makes financial sense for patients to be seen by their GPs. We know that it will give them a better level of care close to their homes but it takes more time to deal with patients with diabetes for both GPs and practice nurses and the HSE hasn’t agreed to fund it.”
Harkins is the author of the as yet unpublished new HSE guidelines for integrated care for Type II diabetes.
She concluded, “Everyone agrees on the model of care but there is no agreement on how to fund diabetes care both in the community and at GP practices.”
News
According to the Fit for Work Coalition, the Government is missing a massive opportunity to save the Exchequer up to ¤55 million each year and they are calling on the Department of Health and Social Protection to create a national programme for early intervention in workplace absence.
Every year in Ireland, a combined average of 7 million working days are lost due to absence and ill health. Musculoskeletal diseases (MSDs), an umbrella term covering over 200 conditions including arthritis, back pain and tendonitis, are to blame in the high incidents of absenteeism.
The current rate of absenteeism costs the State up to ¤275 million in annual Illness Benefit payments per year. If an early intervention programme was put into place, however there is potential to make massive savings of ¤55million (20%) of the total annual Illness Benefit bill for MSDs each year.
Chair of the Fit for Work Ireland Coalition and Chairperson of the National Competitiveness Council, Dr. Don Thornhill, said, “Tackling absenteeism is a no-brainer
Tackle absenteeism, save ¤55 millionThe Fit for Work Ireland Coalition is calling on the Government to tackle workplace absenteeism to help reduce costs in Pharmacy and other retail sectors.
opportunity for the Government. The solution is simple - a national early intervention plan needs to be drawn up and implemented to make a 20% saving of the total MSD Illness Benefit bill.”
In a new survey of more than 300 people with MSDs, conducted by Arthritis Ireland (a founding member of the Coalition), 77% of unemployed participants said they had either lost or given up their job because of their MSD.
Of those who remain in paid employment, 32% said they had switched to part time employment because of their MSD, while a further 23% said they had moved jobs as a result.
Ibec Senior Labour Market Policy Executive, Kara McGann, said, "There are significant direct costs to employers associated with absenteeism, which also creates additional costs that are more difficult to quantify, such as the cost of reduced productivity. Pro-active measures by employers such as holding return to work interviews and putting in place employee health and well-being supports can help to reduce absence.
In conclusion, she said, “Many employers have introduced measures to support employees, better manage absenteeism and promote wellbeing at work, while lowering costs and promoting better employee relations. These include Employee Assistance Programmes (EAPs), wellness programmes and worklife balance initiatives. These initiatives can contribute to an overall healthier workforce, assist with early intervention and in turn minimise absenteeism."
Launching Change Your Health Direction, Ireland’s largest pharmacy group called on Government to introduce a free annual health check as part of its new Universal Health Insurance (UHI) minimal benefits system.
The annual health check, screening blood pressure, cholesterol, weight management and other health essentials at pharmacy and primary care levels, would reduce both costs and pressures on the overall health system, LloydsPharmacy said. This system has been implemented to great success in both Scotland and England as part of the NHS.
Goretti Brady, Managing Director, LloydsPharmacy said, “We know all too well that if certain health conditions are not managed adequately and in good time, they only serve to clog up our already
Calls for free annual health checksLloydsPharmacy have launched its Change Your Health Direction campaign - a new, eight week healthy living programme available exclusively to LloydsPharmacy customers. Through this initiative, LloydsPharmacy aims to support its customers’ healthy living ambitions for 2015.
stretched health services further down the line. With an annual health check as part of UHI, these problems can be detected earlier.
The Government is moving to put UHI in place - now is the time to make an annual health check part of the plan.”
Dr. Don Thornhill, Chair, Fit for Work Ireland Coalition
Beauty expert Laura Bermingham with Seamus Reynold, LloydsPharmacy Blackrock Store Pharmacist
6
news briefBMS TO CONSTRUCT NEW FACILITY IN DUBLIN Bristol-Myers Squibb has announced its plans to construct a new large scale biologics manufacturing facility in Cruiserath, County Dublin.
Once completed, this facility will produce multiple therapies for the Company’s growing biologics portfolio and the facility will play an important role in its global manufacturing network.
CEO of Bristol-Myers Squibb, Lamberto Andreotti said, ““For 50 years, we have maintained a signifi cant manufacturing presence in Ireland, and we look forward to building on that legacy through this signifi cant expansion of our manufacturing capability.”
The Taoiseach, Enda Kenny, TD said “I greatly welcome this investment by Bristol-Myers Squibb, which is a huge boost to the Irish economy.”
NEXT WAVE OF INNOVATIVE MEDICINES Sanofi outlined at an International Relations Thematic Seminar on New Medicines recently, its intention to launch high-potential new medicines and vaccines that could result in up to 18 new launches for the company between 2014 to 2020. These new launches have the potential to cumulatively generate greater than ¤30 billion for the pharma company over the fi rst fi ve years of sales.
By outlining these potential future launches, Sanofi is maintaining the strong momentum of the company’s R&D pipeline and ability to deliver new therapies across a range of therapeutic categories.
CEO of Sanofi , Serge Weinberg, said, “These potential launches affi rm Sanofi ’s strategy, which has been in place since 2008. As we move into this period of successive new product launches, we are investing in launch excellence and execution while continuing to fuel innovation to grow our existing pipeline.”
NewsBetter insurance policies needed for Locum Pharmacists
As it stands at the moment, the only way a locum can guarantee that they’re fully covered in the case of a dispensing or any other type of error, is if they obtain a personal insurance policy to protect themselves. These insurance policies are not easy to come by however as there is no regulation for insurance policies for locum pharmacists in Ireland.
The majority of the larger pharmacy groups in Ireland do have insurance policies for their pharmacists but it’s not always clear if that covers locum pharmacists, and in the case of independent pharmacies it’s unclear as to whether locums are covered by their insurance policies.
Alternatively locum pharmacists can take out their own personal insurance policy however most locums can’t afford the rates some insurance companies are currently charging. For instance some locum pharmacists have been quoted rates of up to ¤2,500 p.a. in comparison to UK insurance companies that only charge locums £150 p.a.
IPN spoke to Garry O’Riordan from locum and Pharmacy recruitment company Pharmaconex and he explained that this is an area that needs to be tackled sooner rather than later.
“At the moment, most locum pharmacists in Ireland don’t have insurance so for the past two years we have been trying to fi nd a company that will provide insurance for our locums. When we fi rst started looking into it we were quoted outrageous amounts of money but this was because insurance company underwriters in London were looking at medical claims as a whole in Ireland and this included larger claims for doctors and hospitals worth millions of euro. When insurance companies discovered these types of cases, they became increasingly afraid of the Irish market place and wouldn’t lower their insurance rates for locum pharmacists.”
O’Riordan continued, “We decided to investigate how many complaints were made to the PSI
every year and, on that basis, fi nd out how many of these cases actually resulted in any action being taken. The result showed very little cases that required any kind of pay out, and there’s very few cases that went all the way through to having the pharmacist actually reprimanded.
“The problem is that insurance policies for locums have never actually been put to the test in Ireland. While some of the larger pharmacy groups are saying that they cover locums in their pharmacies, it doesn’t necessarily mean that a locum is covered if a person decides to sue him/her specifi cally. If somebody is going to sue a pharmacy, they’re going to try and sue as many people as possible. In this regard, they could effectively try to sue the locum personally as well as the pharmacy and that’s where we’re coming from on this issue. It hasn’t happened yet but that’s not to say it won’t happen in the future.”
O’Riordan explains that Pharmaconex did eventually get a quote from an insurance company of ¤400 p.a. to cover its locum pharmacists but to avail of this offer, the insurance company is insisting that their insurance policy be branded by a Union or Association. O’Riordan is currently working on a solution to this problem but it’s taking time.
O’Riordan commented, “It is currently up to locum pharmacists to cover themselves but it’s not an easy thing to do in the Irish market.”
Insurance policies for locum pharmacists in Ireland is an area within Pharmacy that has been overlooked for too long according to Irish pharmacists.
Garry O’Riordan, Operations Director, Pharmaconex
The problem is that insurance policies for locums have never actually been put to the test in Ireland. While some of the larger pharmacy groups are saying that they cover locums in their pharmacies, it doesn’t necessarily mean that a locum is covered if a person decides to sue.
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Noeleen Harvey, owner and Superintendent Pharmacist of Dargan’s Pharmacy in Dublin, took over the family business in 1996. Originally, her grandparents lived above the pharmacy and, since then her father ran the business before she took over the reins some twenty years ago.
Harvey has had to face a tremendous amount of social change during this time and, because of the area she is based in she has come up against many types of new health problems, which she has had to face down (or confront).
Dargan’s pharmacy is located on Berkeley Street, which is in a disadvantaged area of the north inner city of Dublin. There are a number of homeless shelters in the area, many of which have residents who may have mental health or addiction issues.
This may paint a stark picture but that is because there is still a lot more work to be done to help to turn the area around.
Harvey said, “Working in such a disadvantaged area brings its own challenges but it is also very rewarding. There is a lot of politics involved as to why certain things will not change any time soon. I fi rmly believe that, if the Government used community pharmacies outside the city centre more often to help smaller numbers of patients with addiction problems, as opposed to pushing them all into the middle of the city centre, then things could change and work a lot better in the future.”
To combat the ongoing social issues that started creeping into the area in the '90s, Harvey faced a choice. She could either offer harm reduction treatments for those in the area who required such help, which would mean offering supervised methadone as part of the treatment programme She chose to be part of the action which meant working with homeless services. The addiction centre in the area developed from
this collaboration between Harvey and the primary care services in the locality.
Harvey's pharmacy is now embedded in the heart of the local community. The work she and her team in Dargan’s Pharmacy do on an everyday basis is not what people would expect of a typical dispensing pharmacy business because she and her staff have to deal with many complex, sensitive and sometimes challenging social issues.
“The problem began way back when the Jervis Street Hospital ran the only Drug Clinic at the time in Dublin. As the numbers increased, the Clinic moved into Pearse Street and then that became the only place for drug misusers to go. Then, when HIV came in, the
The HSE needs to stop fire fighting within Community Pharmacy and make structured plans for the future.
Profi le
Inspiring change in Community Pharmacy
thinking was that there was no harm reduction treatment, i.e. methadone maintenance available for drug misusers. So Harm Reduction Programmes were also set up in Amien Street and Baggot Street but many of the locals started to object strongly, with the result that only certain catchment areas were covered. We were fortunate because a young GP began working in the local practice and the satellite clinic that developed from this still operates in the area today.
“We have a good working relationship with the local GPs, as well as the mental health services and more specifi cally the Community Mental Health Nurses, the Addiction Services and also Safetynet - the service for the Homeless," Harvey continued.
"But I have to be fair, it’s not just us who work with these patients. Most of the other pharmacies in the area help as well, particularly in the city centre.”
However modest Harvey may be, it is clear that she goes above and beyond for her patients in the community. She and her team also work closely with the nearby Granby Row Centre, a Salvation Army hostel, on pharmaceutical care for the residents.
“We work closely with all the Community Mental Health nurses in the area particularly those from Usher’s Island, which is a homeless psychiatric service on the quays. Some of the residents in the Granby Centre are people who may have been living on the streets so when they come to us via the
Centre we want to be able to help them to sort out their medication so that when they’re able to move out of the Centre, they will be able to manage it themselves,” she said.
CHALLENGES
With the ongoing drug and mental health issues in the area, Harvey says there is a lot more help that she would like to avail of and she hopes that, in the future there will be more linked Primary Care services available to both Pharmacy and patients.
“The structure of Safetynet, a Primary Care Network for Homeless Health Services, who we work quite closely with, and also the structure of the Methadone Treatment Scheme make things much easier than it was 15 or 20 years ago. However, at times it doesn't really make a lot of sense to me how the health service is organised and the fact that there are not certain structures in place.
"I would like the Government to make more of an effort to understand what goes on at a local level and to understand what is needed. The Primary Care Pharmacist for Dublin is based out in Bray and she is the only one for this area. I could really do with a Primary Care Mental Health Pharmacist in this area, who could guide me with particular patients and their care. But there’s nothing like that here at the moment. Instead, I ring the pharmacist in the mental health unit in one of the hospitals to obtain advice. But, it would be very useful to have a specialist in this area.
“I am lucky, though because if a patient comes into the pharmacy and the patient is HIV positive and he or she is obtaining medicines from one of the GUIDE clinics, I know who to contact, be it the addiction services' pharmacist or the person who looks after infectious diseases. That knowledge has solely come through experience and it can be very frustrating at times.”
Harvey has had a long career in Pharmacy and has served as a Member of the Board of the Eastern Regional Health Authority for four years. She also sat as a Member of the Council of the Pharmaceutical Society of Ireland from 2005 to 2011. In both of these roles she studied alternative ways of running drug initiatives in Ireland- and for Pharmacy.
“I would like to see the Highly Specialised Drugs Initiative come to Ireland that is currently being developed in South West Australia. It really works on a local level and I do think there is a need for us, as a country to seriously look at how we manage our drugs' maintenance programmes and the mental health programmes for the homeless. For example, when the Government closed St Brendan’s hospital in Grangegorman on the northside of Dublin, none of the money that was saved was put back into the street services.”
Harvey is also a fan of the Scottish Pharmacy service and said, “If I was to develop a pharmacy service here, then the Scottish Pharmacy structure is what I’d base it on for Ireland. Scottish Pharmacy is more clinically led, as opposed to retail led, and what really interests me the most is that they have a campus from where a lot of their health services are organised. They also have an offi ce within it with about 10 pharmacists working from it. They specialise in the addiction services, the mental health services, working with doctor’s practices and with local community pharmacies. Before setting up a new service in the community, they will look at the area, how they can go about training and developing it and whether those in the area would be interested in participating in the schemes. They will then develop a programme from there. That’s what I think we should be doing here rather than fi re fi ghting all the time when we have to confront a problem.”
Harvey continued, “Why do we always have to have the boxes ticked before we start something? This can be quite frustrating because you’ve got really bright people, who are pharmacists and you’re telling them that they can’t do this and that because that box isn’t ticked and, therefore it is not going to happen.
"Also sometimes the Government makes decisions without consulting pharmacists. A prime example of this is the prescription charge levy. Minister for Health Leo Varadkar will tell you that everybody must pay the levy but sometimes that is diffi cult on the ground. We do charge but there will be people who often don’t have the money. It’s a dilemma, should we refuse to dispense the prescription to people who don’t have the money? Occasionally people who make these decisions need to work on the ground.”
THE FUTURE
Standing in Dargan’s Pharmacy, it is clear that Harvey’s patients, both homeless and their everyday local patients, appreciate the work that she and her team are doing. Everyone who comes into the pharmacy calls Harvey by her fi rst name and she knows virtually everything about them
With no Chief Pharmacist currently sitting in Government, it is diffi cult to envisage how the HSE will plan for evolving pharmacy services in the future. Certainly, there seems to be a need for more resources. But, for now, Harvey will continue to help her patients as best she can even with rising homelessness and more complex medicine usage in Ireland. It is apparent however that she will face increasing pressure in the future, unless the Government gives those on the ground more help.
"It can be a tough job at times and I couldn’t do it without my team; they’re so important to me. I have 15 staff members, fi ve of whom are pharmacists and we have built up strong relationships between us over the years. Likewise, our patients are very important to us.”
She concluded, "By and large, we have a good community here and it is very rewarding when you see a patient get back on their feet again through the help we try to provide for them.”
Profi le
I would like to see the Highly Specialised Drugs Initiative come to Ireland that is currently being developed in South West Australia. It really works on a local level and I do think there is a need for us, as a country to seriously look at how we manage our drugs.
Noeleen Harvey, Superintendent Pharmacist,
Dargan's Pharmacy
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2. Moore A et al. Long-term Safety and Efficacy of Once-Daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of a 1 Year Open Label Study. Journal of Drugs in Dermatology 2014; 13:56-64.
Mirvaso 3mg/g Gel Prescribing Information (UK & IRE)Presentation: 3mg/g brimonidine gel. Indications: Symptomatic treatment of facial erythema of rosacea in adult patients. Dosage and Administration: One application per 24 hours for as long as facial erythema is present. Apply a small pea sized amount to each of the 5 areas of the face: forehead, chin, nose, each cheek. Apply only to the face. Hands should be washed immediately after application. Maximum daily dose is 1g divided into 5 pea sized amounts. There is no data on use in patients under 18 years. Contraindications: Hypersensitivity. Children aged less than 2 years. Patients receiving monoamine oxidase inhibitor therapy & patients on tricyclic or tetracyclic antidepressants
which affect noradrenergic transmission. Precautions and Warnings: Should not be applied close to the eyes or to irritated skin or open wounds. In case of severe irritation or contact allergy, treatment should be discontinued. Mirvaso has not been studied in patients with renal or hepatic impairment. Increases in the daily amount applied and/or frequency of application have not been assessed & should therefore be avoided. Concomitant use of other systemic alpha adrenergic receptor agonists may potentiate undesirable effects in patients; with severe, unstable or uncontrolled cardiovascular disease; with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma or Sjögren’s syndrome. Contains methylparahydroxybenzoate which may cause allergic reactions (possibly delayed), and propylene glycol which may cause skin irritation. Interactions: No interaction studies have been performed. Caution is advised in patients taking substances which can affect the metabolism and uptake of circulating amines. Brimonidine may cause clinically insignificant decreases in blood pressure in some patients, caution is therefore advised when using medicinal products such as anti-hypertensives and/or cardiac glycosides. Pregnancy and Lactation: Mirvaso should not be used during pregnancy or breast-feeding. Undesirable Effects: In clinical trials the most common side effects were typically mild to moderate in severity and usually did not
require discontinuation of treatment. Adverse reactions include: Common (≥1/100 to <1/10) Flushing, erythema, pruritus, skin burning sensation; Uncommon (≥1/1,000 to <1/100) Headache, paraesthesia, eyelid oedema, nasal congestion, dry mouth, rosacea, dermatitis, skin irritation, skin warm, contact dermatitis, allergic contact dermatitis, dry skin, pain of skin, skin discomfort, rash papular, acne, feeling hot, peripheral coldness. Prescribers should consult the summary of product characteristics in relation to other side effects. Packaging Quantities and Cost: 30g UK £33.69 IRE €36.00. MA Number: EU/1/13/904/003. Legal Category: POM. Full Prescribing Information is Available From: Galderma (UK) Ltd, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS. Telephone: +44 (0) 1923 208950 Fax: +44 (0) 1923 208998. Date of Revision: February 2014
Adverse events should be reported. Suspected adverse events can be reported via HPRA Pharmacovigilance, Earlsfort Terrace,
Adverse events should also be reported to Galderma (UK) Ltd.
Date of preparation: December 2014 Code: MRV/021/0214c
8:06 8:16 8:248:028:00 am 8:128:08 8:18 8:268:04 8:14 8:228:10 8:20 8:28 8:30 am
and indicated for the persistent facial erythema of rosacea
NOW GMS REIMBURSED
J682 Mirvaso A4 Ad IRELAND IPN.indd 1 06/01/2015 16:15
12
The HSE is taking ten actions to improve the operation of the medical card system, particularly for people with significant medical needs:
• An enhanced assessment process which takes into account the burden of an illness or a condition;
• The greater exchange of information between the medical card central assessment office and the local health offices;
• People with a serious illness who hold a discretionary card can also be reassured that they will retain their card pending implementation of the actions to improve the operation of the scheme;
• The power of GPs to extend medical cards in difficult circumstances will be strengthened;
• A clinical advisory group is being established by the HSE to develop guidance on assessing applications involving significant medical conditions;
• The default position for medical cards given to people with terminal illnesses is that they will no longer be reviewed;
• The HSE will be empowered to provide people with therapies or appliances if that's what they need, even in the absence of a medical card;
• The HSE will develop a single, integrated process for people to apply for a medical card, a GP visit card, the Long-Term Illness scheme, and the Drugs Payment Scheme;
• Access points will be established around the country in health offices to support and assist people to make applications;
news briefSPINNING PLATES IS KEY TO ACHIEVING SUCCESS Following on from last year’s Spinning Plates business conference in the Village at Lyons, TONiC Consultancy and Real World Retail (rwr) have announced that they will be running the event this year again on Friday March 13 2015 in Dublin.
The event will focus on many aspects of pharmacy. At the event attendees will be able to find out how many pharmacy owners have managed to negate the effect to their bottom line and are now finding ways to grow their profitability. Attendees will also learn practical ideas that can be used in their business.
Director of Real World Retail, Conall Lavery said, “The dispensary still represents the best opportunity to improve pharmacies margins but generic penetration is only part of the story, as the top performers in the business find additional profit in many other places.”
Conor Walker, Director of TONiC Consultancy explained, “Category Planning and Store Development doesn’t have to be complex and we will give practical advice that attendees can use to increase both sales and margins, and decrease stockholding and shrinkage, thereby putting more cash in your bank.”
According to Lavery there is going to be no let-up in reimbursement cuts in 2015 but by attending the event pharmacists can hear about their peers in the same industry who see a bright future in pharmacy and recognise the opportunities that change represents to them.
Last year’s event was booked out completely so early booking is advised. Invitations will be going out in mid-January but in the meantime register your interest with [email protected] or [email protected] to ensure you receive an invitation.
NewsReform of Medical Card schemeRecent steps have been announced to enhance the operation of the medical card scheme and make it more sensitive to people’s needs, especially arrangements relating to the issuing of medical cards on a discretionary basis.
• The Department and the HSE will consider the best way to make medical aids and appliances available to persons who do not hold a medical card, the provision of services to children with severe disabilities, and to enable people with particular needs to have these met on an individual basis rather than awarding a medical card to all family members.
Minister Kathleen Lynch said: “The HSE is comprehensively reforming how the medical card scheme operates so that it will be easier for people to understand and will provide a high-quality customer service. People with a serious illness who hold a discretionary card can also be reassured that they will retain their card pending implementation of the actions to improve the operation of the scheme.”
The new measures build on recommendations set out in two reports which were also published today – the report of the Expert Panel on Medical Need for Medical Card Eligibility, and the
external review of the Medical Card Process, undertaken by Prospectus and Deloitte.
A clinical advisory group will shortly be established by the HSE to develop guidance on assessing applications involving significant medical conditions so as to take account of the burden involved and the needs arising from the condition and to ensure that appropriate services are provided to people who need them. This guidance will be drawn up by this group over the coming months.
Other actions that the HSE will progress in the short-term are:
The development of a single, integrated process for people to apply for a medical card, a GP visit card, the Long-Term Illness scheme, and the Drugs Payment Scheme; and
The establishment of access points around the country in health offices to support and assist people to make applications.
Pictured at the recent Health Innovation Hub in Cork are Dr Coleman Casey, HIH and Robin Hanna, Director, McLernons. The hub facilitates and accelerates the commercialisation of innovative health care solutions and McLernon Computers are participants in an electronic prescription trial in conjunction with Complete GP.
The system being piloted will provide a pathway for electronic transmission of prescriptions, and McLernons are involved in writing the software which will allow MPS to receive the prescription directly from the GP system.
eScript Pilot in Cork
Kathleen Lynch, Minister of State, DOHC
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news briefIRISH CANCER PROJECT RECEIVES FUNDING
The Pancreatic Cancer Research Fund UK has invested £1.2 million into seven ambitious new projects to tackle some of the world’s deadliest cancer and for the fi rst time one of these grants has been awarded to an Irish project, that of Dr Patrick Forde, at the Cork Cancer Research Centre, University College Cork
Dr Forde’s project will evaluate whether targeted short intense electric pulses – which temporarily make tissue more porous – will increase the absorption of chemotherapy drugs in pancreatic tumours. This treatment has shown positive results when trialled with inoperable skin cancers.
If similar results are seen with pancreatic cancer tissue, the team will develop the treatment further through the use of a minimally invasive ‘keyhole’ medical device developed at the Research Centre.
Speaking about the announcement of the grant which coincides with World Pancreatic Cancer Day – (a collaboration between pancreatic cancer charities and organisations around the world to raise awareness of the cancer that has seen barely any improvement in survival rates for 40 years) - Dr Forde said,
“I am delighted and extremely proud to have been chosen along with 6 other worthy projects as a recipient of this grant from the Pancreatic Cancer Research Fund UK. The grant will allow me to employee a researcher to work with me to develop a new pancreatic cancer treatment. Without this grant my research would not be able to continue, so I am extremely fortunate and proud to be the fi rst Irish recipient of this grant.”
NewsPharmapod secures two major Irish Pharmacy industry tenders
Pharmapod won the tenders with the Royal College of Surgeons and the newly-established Irish Institute of Pharmacy (IIOP) which was founded to promote excellence in the areas of patient care, professional standards, education and research in pharmacy practice.
The tenders involve creating products that will drive excellence in the profession of pharmacy.
The fi rst is the Core Competency Self-Assessment Tool (CCSAT) which will be accessible to all pharmacists in Ireland to self-assess their core competencies and identify their professional development needs.
The CCSAT is a browser-based tool to assist all pharmacists whether they are based in hospital, community, industry, academia or regulatory roles.
It has been developed to allow pharmacists to self-refl ect and identify their own learning needs. In the future, demonstrating use of the CCSAT may form part of the ePortfolio review process.
The second tender was for the development of a National Training Programme for Superintendent Pharmacists which adds value to all superintendents, addressing the core learnings needed to carry out their role effectively.
“It’s an exciting new programme which covers challenges specifi c to roles such as superintendents of independent pharmacies through to hospital superintendents and those operating within senior management teams of larger corporate structures where leadership, communications and infl uencing skills are vital,” said CEO Leonora O’Brien, who founded Pharmapod less than two years ago.
“The aim of the programme is to enhance knowledge and skills which are particularly relevant to the leadership and management role of the Superintendent Pharmacist.
“It is designed to stimulate refl ection and self-awareness with the ultimate aim of enhancing the quality of care provided to patients.
“The IIOP are a great organisation to work with and we are delighted to be a part of their drive for professional excellence.”
Superintendent pharmacists interested in participating in the programme should visit the IIOP website (www.iiop.ie) to register.
Participants are required to complete pre-course self-appraisal exercises and attend a two day face-to-face programme and complete post course work.
The programme will also drive the development of pharmacy practice to ensure that it meets the emerging needs of patients and the wider healthcare system.
An innovative Irish start-up has secured two major national tenders to provide unique software and training for the Irish pharmacy profession.
Niamh Bushnell, Dublin Commissioner for Startups, Leonora O'Brien, CEO of Pharmapod
Paul Fahey, Business Development Offi cer, Pharmapod; Mary Rose Burke, Director of Policy and Corporate Affairs, IBEC; Mark McInerney General Manager, Indepharm/Haven Pharmacy Group
NICORETTE® QuickMist is clinically proven to relieve
cravings in just 60 seconds with 2 x 1mg sprays.1
So your patients can finally quit for good.
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Nicorette QuickMist Prescribing Information:Product Name: Nicorette QuickMist 1 mg/spray, Oromucosal Spray, solution. Composition: 0,07 ml contains 1 mg nicotine, corresponding to 1 mg nicotine/spray dose. Form: Oromucosal spray. A clear to weakly opalescent, colourless to light yellow solution. Therapeutic indications: For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit. Advice and support normally improve the success rate. Dosage: Subjects should stop smoking completely during the course of treatment with Nicorette QuickMist. 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. To help stay smoke free after Step III, subjects may continue to use the oromucosal spray in situations when they are strongly tempted to smoke. One spray may be used in situations where there is an urge to smoke, with a second spray if one spray does not help within a few minutes. No more than four sprays per day should be used during this period. Regular use of the oromucosal spray beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the oromucosal spray longer to avoid returning to smoking. Any remaining oromucosal spray should be retained to be used in the event of sudden cravings. Do not administer Nicorette QuickMist to persons under 18 years of age without recommendation from a physician. There is no experience of treating adolescents under the age of 18 with Nicorette 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. Subjects should not inhale while spraying to avoid getting spray into the respiratory tract. For best results, do not swallow for a few seconds after spraying. Subjects should not eat or drink when administering the oromucosal spray. Contraindications: Hypersensitivity to nicotine or to any of the excipients of the oromucosal spray. Children under the age of 18 years. Those who have never smoked. Special warnings and precautions: Nicorette QuickMist should not be used by non-smokers. Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s
angina, severe cardiac arrhythmias, uncontrolled hypertensions or recent cerebrovascular accident should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, the oromucosal spray may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision. 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 reduction in nicotine induced catecholamine release can affect carbohydrate metabolism. Allergic reactions: Susceptibility to angioedema and urticaria. A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions: 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. Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines. Gastrointestinal Disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Transferred dependence: Transferred dependence can occur but is both less harmful and easier to break than smoking dependence. Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, tacrine, clozapine and ropinirole. Excipients: 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. Undesirable effects: Subjects quitting habitual tobacco use by any means could expect to suffer from an associated nicotine withdrawal syndrome that includes four or more of the following: dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating, restlessness or impatience; decreased heart rate; and increased appetite or weight gain. These have been observed in those using the oromucosal spray. Nicotine craving with urge to smoke is also recognised as a clinically relevant symptom, and an important additional element in nicotine withdrawal after
smoking cessation. In addition to this, other cessation-associated symptoms were seen in those using the oromucosal spray: dizziness, presyncopal symptoms, cough, constipation, mouth ulceration, gingival bleeding and nasopharyngitis. Nicorette QuickMist may cause adverse reactions similar to those associated with nicotine given by other means and these are mainly dose-dependent. Allergic reactions such as angioedema, urticaria or anaphylaxis may occur in susceptible individuals. Local adverse effects of administration are similar to those seen with other orally delivered forms. During the first few days of treatment irritation in the mouth and throat may be experienced, and hiccups are particularly common. Tolerance is normal with continued use. Daily collection of data from trial subjects demonstrated that very commonly occurring adverse events were reported with onset in the first 2-3 weeks of use of the oromucosal spray, and declined thereafter. Adverse reactions reported in clinical trials of the oromucosal spray include: Nervous system disorders: Very common: Headache, dysgeusia Uncommon: Paraesthesia Eye disorders: Uncommon: Lacrimation increase Not known: Vision blurred Cardiac disorders: Uncommon: Palpitations Not known: Atrial fibrillation Vascular disorders: Uncommon: Flushing Respiratory, thoracic and mediastinal disorders: Very common: Hiccups Uncommon: Dyspnoea, rhinorrhoea, bronchospasm, sneezing, nasal congestion Gastrointestinal disorders: Very common: Nausea, dyspepsia Common: Vomiting, flatulence, abdominal pain, diarrhoea Uncommon: Gingivitis, glossitis Skin and subcutaneous tissue disorders: Uncommon: Hyperhydrosis, pruritus, rash, urticaria Immune system disorders: Uncommon: Hypersensitivity. General disorders and administration site conditions Very common: Oral soft tissue pain and paraesthesia, stomatitis, salivary hypersecretion, burning lips, dry mouth and/or throat Common: Throat tightness, fatigue, chest pain and discomfort Uncommon: Oral mucosal exfoliation, dysphonia Not known:Allergic reactions including angioedema and anaphylaxis. MA Holder: McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24 Ireland. MA Number: PA 823/49/29. Revision of text: April 2013. Legal Category: Not subject to medical prescription. Further information available upon request from Johnson & Johnson (Ireland) Ltd.
References: 1. Hansson A et al. Craving Relief With A Novel Nicotine Mouth Spray Form Of Nicotine Replacement Therapy. Poster POS3-45 Presented at SRNT, Feb 16–19th, 2011, Toronto, Canada. IRE/NI/13-0599
NICORETTE
cravings in just 60 seconds with 2 x 1mg sprays.nicotine
QuickMist is clinically proven to relieve
cravings in just 60 seconds with 2 x 1mg sprays.1cravings in just 60 seconds with 2 x 1mg sprays.1cravings in just 60 seconds with 2 x 1mg sprays.
New publication shows value of pharmaceutical industry
This is one of the many pieces of data contained in a publication launched last month (November) by IPHA (the Irish Pharmaceutical and Healthcare Association) and Jerry Buttimer TD, Chairman of the Oireachtas Committee on healthcare.
“I think we can sometimes take for granted the sorts of advancements we now have as a result of the research and development pharmaceutical sector,” said Dr Leisha Daly, President, IPHA.
“Twenty years ago HIV / AIDS was a death sentence, now less than twenty years later it is a manageable condition and we are in the process of developing a cure. A twenty year old diagnosed with the condition today can now expect to live into their seventies with today’s medicine. All of this we owe to the research and development pharmaceutical sector and that is why we launched today’s booklet to show the value that it brings to patients, the health service and the economy.”
This publication brings together the underlying facts and fi gures. It outlines the complex and lengthy process of developing
and producing new medicines and explains the real cost of this and how it relates to the price. It explains the wider value of medicines which often gets forgotten in the debate on costs.
“Innovative medicines and vaccines change people’s lives. They improve survival rates and help the better management of chronic diseases, increasing life expectancy. We have seen examples of this recently in the battle to combat the threat of Ebola. Many IPHA companies are working now to accelerate and signifi cantly expand the production of an Ebola vaccine and fortunately this work had already commenced,” said Dr Daly.
Prof Mark Ferguson, Director General of Science Foundation Ireland and Chief Scientifi c Adviser to the Government of Ireland, spoke at the launch about the high standard and the clinical and fi nancial impacts of pharmaceutical research in Ireland. He said,
“Pharma is a hugely important research area in Ireland and there are many collaborations between industry and academic institutions in existence. These collaborations
are delivering excellent research that is having a real impact not just on the Irish economy, but for society. Science Foundation Ireland will continue to support the sector, through SFI Research Centres such as the Synthesis and Solid State Pharmaceutical Centre and programmes such as the SFI Spokes and SFI Industry Fellowships Programme, which are focused on delivering opportunities for pharmaceutical industry partners and researchers to work together and deliver future growth and health benefi ts.”
INNOVATIVE MEDICINES
Advances in medical care including the use of innovative medicines and vaccines have played a crucial part in the huge improvements seen in the health outcomes of the Irish population, with consequent increases in life expectancy, says the Report. However, with increased life expectancy comes new challenges; the growing prevalence of chronic conditions and degenerative diseases mean that more people with some form of medical disability or illness are
living longer. The proper use of medicines and vaccines can have a signifi cant impact on health outcomes in many conditions and can improve health system effi ciency, thereby reducing total healthcare costs and productivity losses in the workplace due to disability and illness.
People with conditions such as diabetes, rheumatoid arthritis and HIV are able to live fuller lives as a result of new medicines. This is perhaps most dramatically illustrated by HIV, where the introduction of the fi rst anti-retroviral treatments (ART) in 1995 followed by further innovative medicines in subsequent years, has seen a huge drop in the death rate from AIDS. A 20 year-old HIV-positive patient on treatment can now expect to live into their early 70s, a life expectancy approaching that of the general population.
Over the past decade alone, innovative medicines are estimated to have accounted for over 73% of the health gains achieved across 30 OECD countries including Ireland.
The last ten years alone life expectancy in Ireland has gone up by four years and is now above the European average. Some of this change can be attributed to lifestyle changes; however the research shows that more than 70% of the increase can be attributed directly to innovations in modern medicines.
Report
Professor Mark Ferguson, Director General, Science Foundation Ireland
BRINGING HEALTH AND
GROWTH TO IRELAND How the pharmaceutical industry helps patients, the health service and the economy
BRINGING HEALTH AND
GROWTH TO IRELAND How the pharmaceutical industry helps patients, the health service and the economy
Innovative medicines
transform people’s lives
Advances in medical care including the use of innovative medicines
and vaccines have played a crucial part in the huge improvements
seen in the health outcomes of the Irish population, with consequent
increases in life expectancy. However, with increased life expectancy
comes new challenges; the growing prevalence of chronic
conditions and degenerative diseases mean that more people with
some form of medical disability or illness are living longer. The
proper use of medicines and vaccines can have a significant impact
on health outcomes in many conditions and can improve health
system efficiency, thereby reducing total healthcare costs and
productivity losses in the workplace due to disability and illness.
• Innovative medicines and vaccines change people’s lives and impact positively on society by
improving survival rates and facilitating the better management of chronic illnesses, eliminating or
reducing the burden of disease and increasing life expectancy.
• People are living longer and more productive lives than ever before. This is due to many factors such
as health system access, higher standards of living, better education, advances in medical care and
technologies and significantly, innovation in medicines1 (see fig. 1).
• Cutting edge medicines and vaccines have virtually wiped out diseases such as diphtheria, smallpox
and polio2. In February 2014, the World Health Organisation officially declared India polio free
following the success of an extensive eradication programme.
• People with conditions such as diabetes, rheumatoid arthritis and HIV are
able to live fuller lives as a result of new medicines3. This is perhaps most
dramatically illustrated by HIV, where the introduction of the first anti-retroviral
treatments (ART) in 1995 followed by further innovative medicines in subsequent years,
has seen a huge drop in the death rate from AIDS (see fig. 2). A 20 year
old HIV-positive patient on treatment can now expect to live into their early 70s, a life
expectancy approaching that of the general population4.
• Over the past decade alone, innovative medicines are estimated to have accounted for
over 73% of the health gains achieved across 30 OECD countries including Ireland5.
1 Lichtenberg, F Pharmaceutical Innovation and Longevity Growth in 30 Developing and High income Countries 2000-2009 NBER Working Paper 18235, National Bureau of Economic Research (2012) 2 WHO: Vaccines-preventable diseases monitoring system (2009)
3 PhRMA: New Medicines. New Hope (Sept 2012)4 Samji H et al. Closing the Gap: Increases in Life Expectancy amongst Treated HIV-Positive Individuals in the United States and Canada. PLoS ONE 2013: 8(12):e813555 EFPIA: 2013
Figure 1: Contribution of innovative medicines to increase in life expectancy (2004-2009)Source: EFPIA 2013 Lichtenberg, F: Pharmaceutical Innovation and longevity growth in 30 developing OECD and high-income countries. 2000 - 2009 (2012)
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72.573.0
2000 2009Other Contributions of Innovative Medicines
Life Expectancy (years)
73.574.0
74.575.0
75.576.0
76.577.0
0
............................
..........................
..............................
+ 1.74 Years
27%
73%
For full prescribing information please visit www.medicines.ie. Legal category: Zithromax, Efexor XL, Lustral, Lipitor, Istin & Zoton FasTab (S1B) Viagra & Xalatan (S1A). MA holder: P�zer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. EPBU/2014/004/1 Date of preparation January 2014
18
Recent data shows that long-term cancer survival rates in Ireland have improved signifi cantly in the last decade – from 42% in the period 1994 -1999 to 60% in 2005-2009 in men and from 52% to 62% over the same period in women due in part to innovative medicines. The rate of decline from coronary heart disease between 1990 and 2011 was 59%, largely as a result of cholesterol-lowering medicines. Life expectancy continues to improve today - and medicines usage has made a major contribution.
THE LIFECYCLE OF MEDICINES
The Report goes on to examine the lifecycle of medicine. This follows a distinct pattern from costly, high risk up-front investment, through a short period of value creation to the delivery of effi ciencies and savings at the end of the patent life.
In Ireland, once a generic copy of a medicine becomes available on the market, the price of the branded product falls to 70% of its original price to wholesaler. Twelve months later, the price drops further to 50% of the original price.
New legislation introduced in 2013 provides for further signifi cant price reductions for groups of off-patent molecules which are deemed ‘interchangeable’ by the Health
Products Regulatory Authority (formerly the Irish Medicines Board) through a system of reference pricing and pharmacist substitution.
SPENDING ON MEDICINES
Less than 13%11 of the health budget in Ireland is spent on medicines. Overall medicines across Europe represent less than 15% of total expenditure although variances exist between disease areas.
Since 2007, the pharmaceutical industry in Ireland has helped the HSE to secure savings of at least ¤800 million in its medicines bill. Average price reductions of 30% per item reimbursed under the various State community drugs schemes have been achieved, with the average cost per item of medicine now running at 2001/2002 levels.
As a greater proportion of the population lives longer, there is an increase in the number of people living with chronic illnesses. Early and appropriate use of medicines and vaccines can help avoid far more costly interventions, such as surgical treatments and hospital stays, thereby creating additional capacity throughout the health system and savings in health budgets.
Keeping the population healthy and productive is a critical priority
and medicines have played and can continue to play a part in this. According to IBEC, there is 11 million days lost every year to absenteeism in Ireland. This costs employers ¤1.5 billion per annum. The appropriate use of medicines can help ease this burden, as patients can manage their illnesses and remain at work, thereby also avoiding a dependence on social welfare.
Medical and surgical advances including the use of medicines also allow more patients in Ireland to be treated as day cases, where previously an expensive hospital overnight stay might have been required. This has contributed to the number of day cases in
Ireland rising from 390,000 in 2002 to over 900,000 in 2012, saving valuable resources and preventing more than half a million unnecessary hospital stays a year.
The Report concludes by stating, “The value provided by the pharmaceutical industry in Ireland extends beyond the delivery of life enhancing and life-saving medicines. Successive Irish governments have for many decades, attracted foreign investment in high value added industries such as pharmaceuticals to Ireland. Today the pharmaceutical industry is one of the biggest employers in the State, generating high quality jobs for graduates and contributing heavily to our export driven recovery and a positive balance of trade in pharmaceuticals.
Ireland’s economic recovery and future prosperity depends on fostering strong, robust and thriving export industries.”
Report
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Medicine pricing in Ireland
– a partnership approach
provides value
• In Ireland, once a generic copy of a medicine becomes available on the market, the price
of the branded product falls to 70% of its original price to wholesaler. Twelve months
later, the price drops further to 50% of the original price.
• New legislation introduced in 20138 provides for further significant price reductions for
groups of off-patent molecules which are deemed ‘interchangeable’ by the Health
Products Regulatory Authority (formerly the Irish Medicines Board) through a system of
reference pricing and pharmacist substitution.
• Medicine pricing is a highly complex issue and a balance must be struck between the
State’s need for value for money and industry’s need to have a fair return on its investment.
The right balance can be achieved through a sound partnership approach with
Government.
• For many years, the State and the IPHA have entered into a series of framework
agreements which determine the terms and conditions under which medicines are
supplied to the Irish health service.
• These formal arrangements between the industry and the State have resulted in a stable,
predictable market where patients have timely access to the full range of cutting edge
medicines regardless of their ability to pay.
A well-functioning healthcare system is an important element of
modern societies and a sound pharmaceutical policy is a
fundamental prerequisite for health systems to perform at the
required level. Health systems are complex mechanisms through
which products, services and care are delivered to patients. Their
success requires joint effort and collaboration amongst all the key
stakeholders. For its part, the research-based pharmaceutical
industry plays an essential role in the supply of innovative
medicines and support to the overall healthcare structure.
8 Health (Pricing and Supply of Medical Goods) Act, 2013 (No. 14 of 2013))
In Ireland, once a generic copy of a medicine becomes available on the market, the price of
the branded product falls to
Twelve months later, the pricedrops further to
of the original price.of its original price to wholesaler.
70% 50%
Figure 3: The changing lifecycle curve of innovative medicinesSource: Delivering value to the UK: The Contribution of the pharmaceutical industry to patients, the NHS and the economy, ABPI 2014
-----------------------------
-----------------------------
Value Creation EfficiencyInnovation
Return onInvestment
Slow and low uptakeUsage restrictions
Low prices
Fast and intenseVolume and price erosionMarket access delays
Current life cycle curve Old life cycle curve
BRINGING HEALTH AND
GROWTH TO IRELAND How the pharmaceutical industry helps patients, the health service and the economy
Spending on medicines
contributes to e�ciencies
and savings
• Less than 13%11 of the health budget in Ireland is spent on medicines. Overall medicines
across Europe represent less than 15% of total expenditure although variances exist
between disease areas (see fig. 8).
• Since 2007, the pharmaceutical industry in Ireland has helped the HSE to secure savings
of at least €800 million in its medicines bill. Average price reductions of 30% per item
reimbursed under the various State community drugs schemes have been achieved,
with the average cost per item of medicine now running at 2001/2002 levels12.
• As a greater proportion of the population lives longer, there is an increase in the number
of people living with chronic illnesses. Early and appropriate use of medicines and vaccines
can help avoid far more costly interventions, such as surgical treatments
and hospital stays, thereby creating additional capacity throughout the
health system and savings in health budgets13.
11 IPHA estimate based on IMS, HSE and Department of Health statistics 12 Dáil Eireann Official Report – 23rd January 2014. Written answer (no. 238) by Minister of State for Primary Care Alex White, T.D.13 EFPIA: 2013
• Pharmaceutical innovation can be marked by high failure rates. On average, only one or two of
every 10,000 promising molecules will satisfy the extensive testing and regulatory
requirements and make it all the way to the pharmacist’s dispensary for use by
patients (see fig. 6).
• The pharmaceutical industry has consistently invested more than any other industrial sector in
innovation, even in times of economic turmoil and financial crisis as experienced in recent
years. The annual spend on research and development by the pharmaceutical industry is 5
times greater than that of the aerospace and defence industries, 4.5 times that of the
chemicals industry and 2.5 times that of the software and computer services industry
(see fig 7).
Inve
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h r
etu
rns
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12 13
10
SOFTWARE &COMPUTER SERVICES
ELECTRONIC &ELECTRICAL EQUIPMENT
CHEMICALS
AEROSPACE & DEFENCE
INDUSTRIAL ENGINEERING
LEISURE GOODS
GENERAL INDUSTRIALS
HEALTHCARE EQUIPMENT& SERVICES
FIXED LINETELECOMMUNICATIONS
OIL & GAS PRODUCERS
BANKS
FOOD PRODUCERS
20 30 40 50 60 70 80 90
PHARMACEUTICAL &BIOTECHNOLOGY
TECHNOLOGY HARDWARE& EQUIPMENT
AUTOMOBILES & PARTS
Figure 7: R&D investments by sector in 2010. Source: The 2011 EU industrial R&D Investment Scoreboard. Joint Research Centre (2011). Brussels: European Commission
Figure 6: The research and development process. IFPMA Facts and Figures 2012
REGULATORYREVIEW
SCALE-UP-TOMANUFACTURING
POST-MARKETINGSURVELIANCE
EARLY PHASERESEARCH
4 - 6 Years
Phas
e I
Phas
e II
Phas
e III
1 Year 6 - 7 Years 0.5 - 2 Years Continuous
PRECLINICALTESTING
ONE MARKETEDMEDICINE
5,000-10,000Compounds
250 5
CLINICALTRIALS
NEW
DRU
G A
PPLI
CATI
ON
SU
BMIT
TED
INVE
STIC
ATIO
NAL
NEW
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G A
PPLI
CATI
ON
SU
BMIT
TED
PATE
NT
APPL
ICAT
ION
S FI
LED
R&D investement 2010 (€ bn)
EU
USA
JAPAN
OTHER COUNTRIES
Figure 8: Analysis of spend on medicines and other healthcare costs in EuropeSource: EFPIA 2013
BRINGING HEALTH AND
GROWTH TO IRELAND How the pharmaceutical industry helps patients, the health service and the economy
Curative & RehabilitativeCare
Other Medical Goods
Ancillary Services
Long-Term Nursing
Medicines
Health Administration &Health Insurance
Prevention & PublicHealth Services
Other
52.8%
13.5%
10.6%
7.6%
4.7%
4.0%3.8%
3.0%
VegetarianVegetarian
49% of Ireland’s adult population regularly suffer from fatigue, tiredness and lack of energySee how Pharmaton can help address this:
Who should take it?Adultswhoareexperiencing:• Fatigue• Temporaryperiodsofexhaustione.g.causedbystress
When should it be taken?Pharmaton®Capsulescanbetakenforupto12weeksduringtemporaryperiodsofexhaustione.g.• Recoveringfromillness• Sittingexams• Feelingofweaknessorlackofvitality• Asasupplementtodietortotreatsymptomsof vitaminandmineraldeficiency
Vitamins, Minerals and SupplementsHow to maintain healthy nutrition through vitamins, minerals and supplements
When advising customers and training healthcare staff, it is essential that they have a good understanding of what each of the vitamins and minerals do, where they are found and how they can be sourced, both in the diet and supplemented, where necessary. Outlined in the table on page 22 are some of the more common vitamins and minerals, their purpose within the body, the symptoms of defi ciency and also the potential effects of untreated defi ciencies.
The Vitamin and Mineral category is an integral part of a pharmacy's total over-the-counter sales. The sale of vitamins throughout pharmacies has increased considerably over the past few years. This implies that people have become more health conscious and are increasingly aware of the benefi ts of supplementing their diets. In Stauntons, our fastest moving vitamin lines include Vitamin C, Centrum Woman, Centrum Women 50+ and B Complex. Our fastest moving minerals include Folic Acid tablets, Iron supplements and Magnesium tablets.
ADVISING CUSTOMERS ON THE CORRECT SUPPLEMENTS
When advising customers to ensure that they are getting the right type of vitamins, minerals or supplements, it is essential that healthcare staff take into consideration some of the following points:
WHAT IS THE CUSTOMER’S MAIN CONCERN?
In the initial consultation, make
Vitamins, minerals and supplements are a key aspect of any Pharmacy business as is the dispensing side of the business and the OTC side. Each of these 'components' work hand in hand to provide patients with the best care possible. As we all know, vitamins and minerals are an essential part of our nutrition and are needed to boost the immune system, support normal growth and development. Ideally, our daily requirements of vitamins and minerals should be sourced from our diet but, with modern day lifestyles and convenience foods being readily available, vitamin supplementation is becoming increasingly important.
Written by: Anne Staunton, Staunton’s Pharmacy, Co Mayo
sure to capture the relevant symptoms of the customer, the duration of these symptoms and the severity.
Next, it is important to establish whether the customer has any pre-existing medical conditions or whether they are taking any prescription or non-prescription medication. It is important to train staff in the most common vitamin and mineral interactions and, if they are unsure as to which vitamins to recommend, they should refer to the pharmacist on duty. Prior to recommending a good supplement, always instruct staff to consider the patient's current diet and then try to offer possible dietary and lifestyle changes that will benefi t the patient in the long term. Selecting the correct formulation of a vitamin supplementation is also an important part of the consultation because many customers may have diffi culty swallowing large capsules or have food intolerances or allergies that may prevent them from taking a certain brand of vitamin supplement. Try to carry a wide range of formulations for each supplement, including liquids, effervescent tablets and, in some cases products as simple as cholesterol-free omega supplements.
As part of general practice, it is important to maintain, review and build knowledge, looking for trends and patterns within the pharmacy to see what supplements are performing best. Then lines can be adjusted accordingly so that you are always bringing the best and most desirable ranges to your customers.
GIVING CHILDREN VITAMINS
Healthy children get their best start in life based on what they consume. Good nutrition begins by serving a wide variety of whole, fresh foods to them as much as possible. Today, twice as many children are overweight than two decades ago. It is essential that staff are trained how to advise parents when it comes to offering their children the best possible nutritional intake. Portion size is vital and parents must understand that kid-sized food portions are also important. A general guide is always serve one-quarter to one-third of the size of adult portions to children. The best way to ensure that children get more vitamins is to aim for more variety, not simply more food. Parents must remember that fresh fruit and vegetables contain the highest concentration of vitamins and minerals and eating their 'fi ve a day' is extremely important.
ELDERLY PEOPLE AND VITAMINS
Ensuring adequate nutrition can be a challenge as people get older. With age, the number of calories a person requires will begin to
decline. Every calorie an elderly person consumes must be packed with nutrition in order to meet their daily requirements. Even then, the person may fall short on what they need. As we age the body becomes less effi cient at absorbing some key nutrients. In addition, the ability to taste food declines, leading to a loss in appetite. Some foods may also become diffi cult to chew or digest. Several key nutrients, which tend to be in short supply as a person ages include Vitamin B12, Folate/Folic Acid, Calcium, Vitamin D, Potassium, Magnesium, Fiber and Omega 3 Fats. Nutritional supplements may not only help decrease the risk of certain diseases but they also replace what may be missing in an elderly person's diet.
At different stages in our lives, the requirements of our body and our ability to utilise certain vitamins and minerals changes. It is important to continuously train staff to ensure that they have a good understanding of these requirements and limitations. Always ensure that each patient is dealt with as an individual and that all aspects of their health and nutrition are dealt with.
Anne Staunton, Staunton’s Pharmacy
22
VMS Feature
VITAMINS
Vitamin B1 (thiamine
Vitamin B2 (riboflavin)
Vitamin B6 (pyridoxine)
Vitamin B12 (cyanocobalamin)
Niacin
Fat soluble vitamins: Vitamin A (retinol)
Vitamin D (calciferol)
Vitamin E (tocopherol)
PURPOSE
Breaks down carbohydrate, fat and alcohol.
Extracts energy from fat, protein and carbohydrate.
Breaks down protein and metabolizes hemoglobin, essential for energy and normal brain function
Involved in production of red blood cells, in cell metabolism and in nerve function.
Helps maintain the condition of your skin reduces certain types of fat in your blood and raises others.
Fat-soluble vitamin
Controls the absorption of calcium and phosphorus
Protects red blood cells and is important in reproduction, acts as an antioxidant, preventing cell damage.
SOURCES
Cereals and bread, offal, pork, nuts, and legumes.
Dairy products, meat, fish, asparagus, broccoli, poultry and spinach
Meat, fish, shellfish, poultry, eggs and dairy products, some fortified breakfast cereals.
Lean meats, poultry, fish, organ meats, brewer’s yeast, peanuts and peanut butter
Manufactured in the body, found in spinach, carrots, broccoli, cantaloupe, mangos, apricots, vegetable soup and tomato juice. Meat, liver, beef, chicken, whole milk and eggs.
Fatty fish inc . sardines and tuna, liver, egg yolks, margarine, breakfast cereals vitamin D-fortified milk.Vitamin D is also produced in the body when the skin is exposed to sunlight.
Poor vision, poor bone growth, poor reproduction and immune growth.
Low back pain, proximal muscle weakness, muscle aches, and throbbing bone pain
Mild hemolytic anemia and nonspecific neurologic deficits.
EFFECTS OF DEFICIENCY
Cardiac and neurological problems
There is no evidence that riboflavin has toxic effects on the body.
Dietary deficiency is rare. Secondary deficiency may result from various conditions. Symptoms can include peripheral neuropathy, a pellagra-like syndrome, anemia, seizures.
Pernicious anemia, severe neurologic problems, blood diseases
Pellagra, problems with skin, digestive system, and nervous system.
Deficiency is rare in the Western world, but inadequate amounts of vitamin A can cause vision impairment liver and bone damage, birth defects, osteoporosis
Rickets, osteoporosis, which leads to weak, soft bones.
Hemolytic anemia and neurologic deficits.
Common vitamins and minerals there purpose. Deficiency effects and symptoms
MINERAL
Calcium
Iron
PURPOSE
Important for the development of strong teeth and bones and for healthy muscle and nerve function
Iron is a mineral that is an essential part of blood and muscle. It is important for the transport of oxygen around the body in the blood.
SOURCES
Milk, cheese, yogurt, goat’s milk, fortified soya milk, mineral water, ice cream, tinned fish, calcium-fortified tofu, calcium-fortified juices and cereals; and broccoli.
Red Meat, seafood and poultry.
SYMPTOMS OF DEFICIENCY
Memory loss, muscle spasms, numbness and tingling in the hands, feet, and face, depression, hallucinations
Excessive tiredness, pale skin and poor resistance to infection.
POTENTIAL AILMENTS
Osteoporosis
Anemia (This can affect the growth and development of infants)Those with conditions that cause internal bleeding, such as ulcers or intestinal diseases are also susceptible to this condition.
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Venlafaxine XLXL*
ABBREVIATED PRESCRIBING INFORMATION (Ireland) NOTE: Refer to the currently approved Summary of Product Characteristics (SPC) before prescribing. EFEXOR* XL Hard Prolonged-Release Capsules, venlafaxine Presentation: Efexor XL 37.5mg, 75mg and 150mg Hard Prolonged-Release capsules: capsules containing 37.5mg, 75mg or 150mg venlafaxine (as hydrochloride) in an extended release formulation. Indications: Efexor XL Capsules: Treatment of major depressive episodes, generalised anxiety disorder (GAD), social anxiety disorder (SAD) and panic disorder, with or without agoraphobia and for the prevention of recurrence of major depressive episodes. Dosage and Administration: For oral use. Adults (including the elderly): Major depressive episodes: Usually 75mg/day with food. For non-responders, dose increases can be made, up to a maximum dose of 375mg/day, at intervals of 2 weeks or more, but not less than 4 days. Recurrence of major depressive episodes: Usually, the dosage for recurrence of a new episode is similar to that used during the index episode. Patients should be re-assessed regularly in order to evaluate the benefit of long-term therapy. GAD and SAD: 75mg/day with food. For non-responders, dose increases can be made up to a maximum dose of 225mg/day. Dose increments should be made at intervals of 2 weeks or more. Panic Disorder: Treatment should be started with a dose of 37.5mg/day for the first 7 days, after which the dose should be increased to 75mg/daily. Maximum 225mg/day. Dose increments can be made at intervals of 2 weeks or more. Children: Efexor should not be used in the treatment of children and adolescents under the age of 18 years. Renal impairment: No change in dosage, caution advised for patients with glomerular filtration rate (GFR) between 30-70ml/minute. For patients with severe renal impairment or requiring haemodialysis, reduce dose by 50%. Hepatic impairment: Mild to moderate hepatic impairment: consider reducing dose by 50%. Severe hepatic impairment: consider reducing dose by more than 50%. Discontinuation: Discontinue gradually reducing the possibility of withdrawal reactions. Contraindications: Concomitant use with MAOIs, hypersensitivity to venlafaxine or any of the excipients. Precautions/Warnings: The risk of suicide should be considered in all patients and patients with history of suicide-related events or ideation should be carefully monitored. Do not treat children/adolescents under the age of 18. Suicide related behaviours and hostility were more frequently observed in this group. Serotonin syndrome, mydriasis, dose related increase in blood pressure, increase in heart rate, convulsions, hyponatraemia, Syndrome of Inappropraite Antidiuretic Hormone, reduced platelet function, bleeding events related to SSRI and SNRI use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to gastrointestinal and life-threatening haemorrhages, increases in serum cholesterol, mania/hypomania (patients with mood disorder), akathisia, dry mouth, alteration of glycaemic control (diabetic patients) may occur with venlafaxine treatment. Venlafaxine has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease. Use in combination with weight loss agents has not been established. Risk of withdrawal symptoms depend upon duration, dose and tae of dose reduction. Interactions: Do not use venlafaxine in combination with MAOIs or within 14 days of stopping MAOI treatment. Allow 7 days after stopping venlafaxine before starting an MAOI. Serotonin syndrome, a potentially life threatening condition, may occur with venlafaxine treatment, particularly with concomitant use that may affect the serotonergic neurotransmitter system (including triptans, SSRIs, SNRIs, lithium, sibutramine, St John’s Wort [Hypericum perforatum], fentanyl and its analogues, tramadol, dextromethorphan, tapentadol, pethidine, methadone and pentazocine), with medicinal agents which impair metabolism of serotonin (such as MAOIs e.g methylene blue), with serotonin precursors (such as tryptophan supplements) or with antipsychotics or other dopamine antagonists. Patients should be advised to avoid alcohol consumption. Use with caution in patients taking other CNS active drugs, lithium, imipramine, metoprolol, haloperidol, risperidone, indinavir and in patients taking drugs which inhibit the CYP3A4 hepatic enzyme. Pregnancy and Lactation: There is no adequate data from the use of venlafaxine in pregnant women. The potential risk to humans is unknown. Venlafaxine must only be administered to pregnant women if the expected benefits outweigh any possible risk. Venlafaxine and its active metabolite are excreted in breast milk. Therefore a decision to continue/discontinue breast-feeding or continue/discontinue therapy with Efexor should be made. Adverse reactions: Very common: ≥1/10: nausea, headache, dizziness, dry mouth, sweating (including night sweats). Common: ≥1/100 to <1/10: insomnia, nervousness, accommodation disorder, visual impairment, including blurred vision, ejaculation disorder, hypertension, palpitations, vasodilatation (mostly hot flashes/flushes), asthenia, fatigue, decreased appetite, vomiting, diarrhoea, constipation, chills, blood cholesterol increased, abnormal dreams, somnolence, confusion, depersonalisation, increased muscle tonus (hypertonia), paraesthesiatremor, anorgasmia, erectile dysfunction (impotence), decreased libido, menstrual disorders associated with increased bleeding or increased irregular bleeding (e.g. menorrhagia, metrorrhagia), dysuria (mostly urinary hesitation), pollakiuria, yawning, mydriasis, tinnitus. Uncommon: ≥1/1000 to <1/100: gastrointestinal haemorrhage, syncope, dyspnoea tachycardia. Not Known: syndrome inappropriate antidiuretic hormone secretion (SIADH), neuroleptic malignant syndrome (NMS), serotonergic syndrome, hypotension, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, ventricular tachycardia (including Torsade de Pointes), ventricular fibrillation, anaphylactic reaction, suicidal ideation and suicidal behaviours. Cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation. Hostility, suicidal ideation, self harm, abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis and myalgia in paediatric patients. Discontinuation of venlafaxine (particularly when abrupt) commonly leads to withdrawal symptoms. Legal category: S1A. PA numbers: 37.5mg capsule - PA 822/72/1; 75mg capsule - PA 822/72/2; 150mg capsule - PA 822/72/3. For full prescribing information refer to the summary of product characteristics. The Marketing Authorisation Holder: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. Telephone: + 353 1 4676500. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at [email protected]. For queries regarding product availability please contact: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500. Date of Revision of Text: September 2013 * Trade mark. Ref: EF 6_0
References: 1. Cipriani A, et al. Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis. Lancet. 2009;373: 746-58. 2. De Nayer A, Geerts S, Ruelens L, et al. Venlafaxine compared with fluoxetine in outpatients with depression and concomitant anxiety. Int J Neuropsychopharmacol. 2002;5:115-120. 3. Original data on file. 4. MIMS April 2014. 5. Current data on file. 6. Efexor XL is manufactured by Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, Co Kildare Ireland , Pfizer Healthcare Ireland Press Release 11/07/2013.
Date of preparation: May 2014 EFX/2014/004/2
Venlafaxine XL
XL*
Venlafaxine has shown bettertolerability in patients Vs duloxetine 1
This is My Road.This is My Road.
ABBREVIATED PRESCRIBING INFORMATION (Ireland) NOTE: Refer to the currently approved Summary of Product Characteristics (SPC) before prescribing. EFEXOR* XL Hard Prolonged-Release Capsules, venlafaxine Presentation: Efexor XL 37.5mg, 75mg and 150mg Hard Prolonged-Release capsules: capsules containing 37.5mg, 75mg or 150mg venlafaxine (as hydrochloride) in an extended release formulation. Indications: Efexor XL Capsules: Treatment of major depressive episodes, generalised anxiety disorder (GAD), social anxiety disorder (SAD) and panic disorder, with or without agoraphobia and for the prevention of recurrence of major depressive episodes. Dosage and Administration: For oral use. Adults (including the elderly): Major depressive episodes: Usually 75mg/day with food. For non-responders, dose increases can be made, up to a maximum dose of 375mg/day, at intervals of 2 weeks or more, but not less than 4 days. Recurrence of major depressive episodes: Usually, the dosage for recurrence of a new episode is similar to that used during the index episode. Patients should be re-assessed regularly in order to evaluate the benefi t of long-term therapy. GAD and SAD: 75mg/day with food. For non-responders, dose increases can be made up to a maximum dose of 225mg/day. Dose increments should be made at intervals of 2 weeks or more. Panic Disorder: Treatment should be started with a dose of 37.5mg/day for the fi rst 7 days, after which the dose should be increased to 75mg/daily. Maximum 225mg/day. Dose increments can be made at intervals of 2 weeks or more. Children: Efexor should not be used in the treatment of children and adolescents under the age of 18 years. Renal impairment: No change in dosage, caution advised for patients with glomerular fi ltration rate (GFR) between 30-70ml/minute. For patients with severe renal impairment or requiring haemodialysis, reduce dose by 50%. Hepatic impairment: Mild to moderate hepatic impairment: consider reducing dose by 50%. Severe hepatic impairment: consider reducing dose by more than 50%. Discontinuation: Discontinue gradually reducing the possibility of withdrawal reactions. Contraindications: Concomitant use with MAOIs, hypersensitivity to venlafaxine or any of the excipients. Precautions/Warnings: The risk of suicide should be considered in all patients and patients with history of suicide-related events or ideation should be carefully monitored. Do not treat children/adolescents under the age of 18. Suicide related behaviours and hostility were more frequently observed in this group. Serotonin syndrome, mydriasis, dose related increase in blood pressure, increase in heart rate, convulsions, hyponatraemia, Syndrome of Inappropraite Antidiuretic Hormone, reduced platelet function, bleeding events related to SSRI and SNRI use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to gastrointestinal and life-threatening haemorrhages, increases in serum cholesterol, mania/hypomania (patients with mood disorder), akathisia, dry mouth, alteration of glycaemic control (diabetic patients) may occur with venlafaxine treatment. Venlafaxine has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease. Use in combination with weight loss agents has not been established. Risk of withdrawal symptoms depend upon duration, dose and tae of dose reduction. Interactions: Do not use venlafaxine in combination with MAOIs or within 14 days of stopping MAOI treatment. Allow 7 days after stopping venlafaxine before starting an MAOI. Serotonin syndrome, a potentially life threatening condition, may occur with venlafaxine treatment, particularly with concomitant use that may affect the serotonergic neurotransmitter system (including triptans, SSRIs, SNRIs, lithium, sibutramine, St John’s Wort [Hypericum perforatum], fentanyl and its analogues, tramadol, dextromethorphan, tapentadol, pethidine, methadone and pentazocine), with medicinal agents which impair metabolism of serotonin (such as MAOIs e.g. methylene blue), with serotonin precursors (such as tryptophan supplements) or with antipsychotics or other dopamine antagonists. Patients should be advised to avoid alcohol consumption. Use with caution in patients taking other CNS active drugs, lithium, imipramine, metoprolol, haloperidol, risperidone, indinavir and in patients taking drugs which inhibit the CYP3A4 hepatic enzyme. Pregnancy and Lactation: There is no adequate data from the use of venlafaxine in pregnant women. The potential risk to humans is unknown. Venlafaxine must only be administered to pregnant women if the expected benefi ts outweigh any possible risk. Venlafaxine and its active metabolite are excreted in breast milk. Therefore a decision to continue/discontinue breast-feeding or continue/discontinue therapy with Efexor should be made. Adverse reactions: Very common: ≥1/10: nausea, headache, dizziness, dry mouth, sweating (including night sweats). Common: ≥1/100 to <1/10: insomnia, nervousness, accommodation disorder, visual impairment, including blurred vision, ejaculation disorder, hypertension, palpitations, vasodilatation (mostly hot fl ashes/fl ushes), asthenia, fatigue, decreased appetite, vomiting, diarrhoea, constipation, chills, blood cholesterol increased, abnormal dreams, somnolence, confusion, depersonalisation, increased muscle tonus (hypertonia), paraesthesiatremor, anorgasmia, erectile dysfunction (impotence), decreased libido, menstrual disorders associated with increased bleeding or increased irregular bleeding (e.g. menorrhagia, metrorrhagia), dysuria (mostly urinary hesitation), pollakiuria, yawning, mydriasis, tinnitus. Uncommon: ≥1/1000 to <1/100: gastrointestinal haemorrhage, syncope, dyspnoea tachycardia. Not Known: syndrome inappropriate antidiuretic hormone secretion (SIADH), neuroleptic malignant syndrome (NMS), serotonergic syndrome, hypotension, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, ventricular tachycardia (including Torsade de Pointes), ventricular fi brillation, anaphylactic reaction, suicidal ideation and suicidal behaviours. Cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation. Hostility, suicidal ideation, self harm, abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis and myalgia in paediatric patients. Discontinuation of venlafaxine (particularly when abrupt) commonly leads to withdrawal symptoms. Legal category: S1A. PA numbers: 37.5mg capsule - PA 822/72/1; 75mg capsule - PA 822/72/2; 150mg capsule - PA 822/72/3. For full prescribing information refer to the summary of product characteristics. The Marketing Authorisation Holder: Pfi zer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. Telephone: + 353 1 4676500. For further information on this medicine please contact: Pfi zer Medical Information on 1800 633 363 or at EUMEDINFO@pfi zer.com. For queries regarding product availability please contact: Pfi zer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500. Date of Revision of Text: September 2013 * Trade mark. Ref: EF 6_0
References: 1. Cipriani A, et al. Comparative effi cacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis. Lancet. 2009;373: 746-58.
Date of preparation: May 2014 EFX/2014/004/2
25
Education
Educational focus on Depression
Depression affects people of all ages, including children and teenagers.
According to Aware, a voluntary organisation which supports people with depression, over 300,000 people in Ireland currently suffer from the illness.
Women are more likely to become affected because one in four women will suffer from some form of clinical depression during their lifetime, compared to one in 10 men.
In further shocking statistics released this year, suicide among teenage girls in Ireland is higher now than in any other EU state, while the suicide rate for teenage boys in Ireland is the second highest in Europe.
With pharmacists being the fi rst point of primary care in many communities, the question now becomes: "Should pharmacists be looking out for signs of increased depression and suicidal tendencies in patients who come in to collect the medication that a GP has prescribed for them?"
DEPRESSION AND HOW IT CAN PRESENT ITSELF
If a patient constantly presents in a low mood over a two-week period whilst picking up his/her prescription, should a pharmacist refer the patient back to his doctor or local support group?
Some patients may know that they are depressed but there are many, who do not realise that they are. They may know that they are not feeling quite right and that they are not functioning properly but they don’t actually know why.
Symptoms to watch out for are:
• Persistent sadness or low mood. This may be with or without weepiness
• Marked loss of interest or pleasure in activities, even for activities that the patient normally enjoys
• Disturbed sleep compared with the patients usual pattern. This may be diffi culty in getting off to sleep, or waking early and being unable to get back to sleep.
Depression is an illness which has come under the spotlight in Ireland over the last few years. It is a subject that, until recently was taboo among Irish people but, with the statistics showing that increasing numbers of people are becoming depressed every year, it is an illness that has become of great concern within Society.
Sometimes it is sleeping too much.
• Change in appetite. This is often a poor appetite and weight loss. Sometimes the reverse happens, i.e. comfort eating and weight gain.
• Fatigue (tiredness) or loss of energy.
• Agitation or slowing down of movements.
• Poor concentration or indecisiveness. For example, the patient may fi nd it diffi cult to read, work, etc. Even simple tasks can seem diffi cult.
• Feelings of worthlessness, or excessive or inappropriate guilt.
• Recurrent thoughts of death. This is not usually a fear of death, more a preoccupation with death and of dying. For some people's despairing thoughts, such as "Life's not worth living" or "I don't care if I don't wake up" are common. Sometimes these thoughts progress to thoughts and even plans for suicide.
Many people with depression say that their symptoms are often worse fi rst thing each day. Also, with depression, it is common to develop physical symptoms such as headaches, palpitations, chest pains and general aches. In fact, some people will consult a doctor initially because they are suffering physical symptoms, such as chest pains - they are concerned that they may have a physical problem when actually it is due to depression. Depression can quite often cause physical symptoms and the converse is also true.
WHAT KIND OF TREATMENT SHOULD PHARMACISTS ADVISE?
There are many different forms of treatment available for patients suffering from depression and they can be divided into those which are used for mild depression and those which are used for moderate/severe depression. A GP will always be the person to prescribe anti-depressant medication and, possibly psychological treatment if they think there is a need for it but there
are other forms of treatment which pharmacists can suggest.
1) A guided self-help programme - There are various pamphlets, books and audio tapes, which can help a patient to understand and combat depression. The best are based on the principles of cognitive behavioural therapy (CBT).
2) Group-based cognitive behavioural therapy – this is also CBT but in a setting of eight to 10 participants. Typically, it consists of 10 to 12 weeks.
3) Group-based peer support. This is an option for people with depression who also have an ongoing (chronic) physical problem. This permits the sharing of experiences and feelings with a group of people, who understand the diffi culties and issues facing group members.
HOW CAN PHARMACISTS HELP THEIR PATIENTS?
IPN spoke to Ultan Molloy from HealthWest Community Pharmacy, Co Mayo, who said, “Pharmacists are well placed to engage with patients and customers around what's happening for them in their lives and advise around lifestyle modifi cations that will likely help - e.g. regular exercise, healthy diet, etc. Pharmacists can help their patients "problem solve" around these things.
“It has been well documented that exercise has signifi cant positive effects on mental and physical health, so I am a big advocate of this. When patients suffering from depression present in my pharmacy, I can understand why some of them can fi nd it diffi cult to "get going" with exercise, and I try to emphasise the benefi ts over the status quo with some people.
“We also see patients who are taking prescribed anti depressants, and we always promote their compliance as part of a holistic view of patient care. Anti depressants are a highly effective tool. A pharmacist can also discuss with their patient, how to take their medicines effectively, and in conjunction with a healthy diet and exercise. If a pharmacist
notices that something might be wrong then they should always advise the patient to return to their GP should further medical intervention be necessary during the course of their treatment.”
It is also a good idea to remember to advise patients about the side-effects of starting on a course of anti-depressants. The patient’s doctor will most likely run through this but it is always good to remind the patient again when they come in to collect their prescription. By alerting patients about certain issues they may have to tackle, patients can prepare themselves for what might be in store for them.
Shane Connolly, MD of Connolly’s Pharmacy spoke to IPN and said, “When a patient fi rst comes into a pharmacy to collect their anti-depressants, they should always be advised on the following points:
1. It may take two weeks for the medication to start working properly; however, side effects such as tummy upsets may start before this.
2. It will take four weeks before the anti-depressants start to take maximum effect so patience is required.
3. Exercise - even a brisk walk during the day will help to relieve anxiety. Exercise works twofold: (1) by helping to release pent up anxiety from the body by movement and (2 ) by releasing endorphins, which are 'feel good' hormones throughout the body. The patient will also sleep better at night by having some sort of physical exercise during the day
4. Advise the patient to make short-term goals
5. Remind the patient that anti-depressants are non-addictive but, once they feel that they are ready to come off them they should do so under the direction of their doctor because coming off the medication can cause withdrawal symptoms. Consequently, patients need to be weaned off them gradually.
26
Pharmacists and pharmacy staff should be aware of the following guidance and counsel parents and carers accordingly.
When oral or rectal ibuprofen is supplied for symptomatic treatment of mild to moderate pain
Ibuprofen in children and adolescents
and/or fever, parents and carers should be advised that:
• Medical advice should be sought for children aged 3 - 5 months if symptoms worsen, or not later than 24 hours if symptoms persist.
• Medical advice should be sought for children aged from 6 months upwards and in adolescents if symptoms worsen, or if this medicinal product is required for more than 3 consecutive days.
The Summary of Product Characteristics (SmPC) and Package Leaflet of all affected medicines are being updated to reflect this information.
News
news briefNEW CHIEF EXECUTIVE FOR IPHA The Irish Pharmaceutical Healthcare Association (IPHA), representing the research-based pharmaceutical industry in Ireland, has appointed Mr Oliver O’Connor as its new Chief Executive.
A former Special Advisor in the Irish Government, 2001-2010, for Ms Mary Harney in her roles as Tánaiste, Minister for Enterprise, Trade and Employment and Minister for Health and Children, he was central to key initiatives such as the National Treatment Purchase Fund and the Fair Deal Nursing Home Support Scheme.
Since 2010, Mr O'Connor has been a Health Finance Consultant, with a focus on the interaction of commercial strategies and public policy. He has had clients among health insurers, public and private hospitals, pharmaceutical companies, new technology providers, logistics providers and industry associations.
He has also been a weekly business columnist for the Irish Times and a frequent contributor to the Sunday Business Post, Sunday Independent and the Wall Street Journal Europe.
“Oliver’s considerable experience across public and private sector will enable a smooth transition for the Association at this critical time. He has high level experience in Government, healthcare, financial services and media. In January this year, he organised a successful CEO Forum in Dublin with Stanford University Faculty in Dublin on the theme of 'Achieving High Efficiency and Best Outcomes in Health', which was attended by leaders across the health sector and recognized as an example of best practice. Oliver’s track record of bringing together a variety of decision makers from different sectors is excellent and I look forward to working with him closely in his new role,” comments Dr Leisha Daly, President of the IPHA and Country Director of Janssen, the pharmaceutical division of Johnson & Johnson.
The PSI would like to highlight updated information on the use of ibuprofen in children and adolescents. These changes were brought to their attention by the Health Products Regulatory Authority (HPRA) following a public assessment report for ibuprofen at European level.
Pharmacist fined for illegal trading
Dispensing prescription medication via the internet has always been illegal in Ireland and now more than ever the Government are clamping down on this activity.
Stephen McClelland, who runs a community pharmacy in Co Donegal, was fined a total of £1,200 plus court costs in a recent court case, having pleaded guilty to six charges of unlawfully advertising and supplying a range of medicines during an eight month period last year.
McClelland supplied the medication between 14 July 2012 and 20 February 2013.
The 38 year old was convicted at Londonderry Magistrates’ Court for advertising and supplying medicines via a mainstream internet auction site.
The medicine sold online included those which require a prescription and others which were unauthorised for sale in the UK.
A total of 160 unauthorised prescriptions were sold with an approximate value of £1,400.
Defence solicitor, Seamus Quigley, told the court that the medication and prescription drugs included stomach tablets and nasal spray and were not illegal.
Mr Quigley said, “This was not a huge business. It was really something of a hobby.”
District Judge Barney McElholm said he was not aware of anyone
coming to harm by taking a nasal spray.
McElholm continued, “Of course, the department have to regulate the supply and sale of drugs. At the same time, these were not illegal drugs. What was being done was unlawful, but I don’t think it was inherently dangerous.”
Department of Health Social Services & Public Safety, Medicines Regulatory Group Senior Enforcement Officer, Mr Peter Moore, took a different stance however and said, “It is
vital that we continue to get the message across that the use of medicines sourced in this way is a real risk. My advice to the public is that they should only take Prescription Only Medicines after an appropriate consultation with their GP. Only healthcare professionals can take into account risks and benefits associated with every medicine.”
McClelland was fined £1,200 and ordered to pay £19 court costs and a £15 offender’s levy.
The Government are clamping down on illegal internet sales of prescription medicine
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28
Atopic Eczema
The main focus of this article is on atopic dermatitis. There are various other types of Eczema.
a. Contact Eczema – This often affects the hands and can be due to chronic irritants or allergic contact dermatitis. Patch testing is often indicated in this condition.
b. Nummular/Discoid Eczema – This is usually a well defi ned circular area of rough thick skin.
c. Pomphloyx – This consists of very itchy small blisters affecting the hands and feet.
d. Eczema Herpeticum – Patients with Eczema have a higher risk of developing herpes. This can be a medical emergency needing urgent anti-viral treatment.
e. Stasis dermatitis – Dryness, irritation and pigmentation affecting the lower legs generally related to poor circulation/varicose veins.
CAUSES AND GENETICS:
There is no one causative factor for Eczema. Recent research suggests a genetically determined defect in a skin barrier protein (fi laggrin). This results in
dehydration, skin dryness allowing easier penetration of the skin by irritants, allergens and bacteria. The resulting infection and allergies lead to aggravation of the Eczema.
Atopic Eczema has a strong genetic component with increased risk of Asthma, Hay Fever and Rhinitis. If both parents have eczema, there is a 75 – 80% chance of developing eczema at some stage with 70%-80% commencing in the fi rst two years of life. Approximately 60% of sufferers grow out of eczema by age 18 but the high recurrence rate means that occupational advice is important.
CLINICAL FEATURES:
Eczema severity and appearance varies widely but the most common form of Eczema is that of dry, itchy red scaly patches. In infancy, the rash often occurs on the scalp and cheeks and itching may lead to severe skin infections. The more classical Eczema occurs from two years onwards, mainly affecting the creases of the elbows and knees and also the wrists, ankles and neck.
AGGRAVATING FEATURES:
Non-specifi c irritants include washing powders, toiletries, cosmetics, overheating and weather change. Eczema can be aggravated at the time of hormonal change e.g. puberty, pre-menstrually and menopause.
Stress – It is generally accepted that stress can aggravate Eczema but is not the underlying cause.
DIAGNOSIS:
A diagnosis is generally clear from the history and clinical examination.
TREATMENT
GENERAL ADVICE:
1. Moisturise daily, even when eczema is well controlled.
2. Wear cotton and soft fabrics avoiding rough fi bres e.g. wool.
3. Use soap substitutes and after washing, pat dry with a towel rather than rubbing.
4. Keep fi nger nails short to prevent scratching leading to infection.
MOISTURISERS (EMOLLIENTS):
The importance of moisturisers has become even more important in view of research showing the role of defective skin barrier in eczema. Moisturisers generally come as lotions, creams and ointments depending on the lipid content. Ointments are generally more effective with dry skin. However, cosmetic acceptability can be problematic and the combination of creams and ointments may be more acceptable. Patients generally fi nd which preparation suits them best. One effective method of moisturising dry skin is to put 2 tablespoons of emulsifying ointment into boiling water and whisk until a cream-like substance emerges. Mix into a tepid bath and soak for approximately 20 mins. The skin should be patted dry and the emollient applied in the direction of the hair follicles.
STEROID PREPARATIONS:
These have been the traditional treatment of Eczema for many years. There are four strengths of steroid preparations, ranging from mild (1% hydrocortisone) up to very potent (Clobetasol Dermovate), which is 1,000 times stronger. Side effects of inappropriate use are well known, i.e. skin thinning and striae. The strength and amount used will depend on the age of the sufferer, severity, body sites and amount of affected areas. In general, the higher potency steroids are used on the thick skin of the hands and feet, with lower strengths being used on the more sensitive areas, i.e. face, skin folds and genital area.
Tacrolimus may be of benefi t particularly in certain areas, e.g. the face where high concentrations of steroids are contra indicated. However, a signifi cant minority has side effects e.g. burning, redness and herpes.
Antihistamines may be valuable for short periods (approximately one week) if severe itching or urticaria is present. Sedating antihistamines are generally more effective.
INFECTION IN ECZEMA:
Almost all Eczema patients have staphyloccus aurus on the skin (90%) and infection is the most common cause of a sudden fl are-up. Localised treatment with Fucibet or Fucidin H may be suffi cient but antibiotics (Flucillin) for a minimum of 10 days may be required for a more generalised fl are-up. For recurrent infection, Oilatum Plus on a regular basis may be benefi cial
ALLERGY AND COMPLEMENTARY MEDICINE:
I have had a special interest in Allergy and Complementary Medicine since the 1980s. The role of diet and allergy in Eczema has remained controversial. Allergic factors are more likely with a family history of allergy including Asthma, Eczema and Rhinitis. Food allergy should be investigated, particularly during the fi rst two years of life and if Eczema is moderately severe. The role of allergy is clarifi ed by a combination of a detailed history, allergy testing and response to treatment programme. Skin Prick Testing (SPT) can be carried out on the majority of patients in the Clinic and results are obtained immediately. A small minority are not suitable for SPT, e.g. history of anaphylaxis or severe Eczema. In these patients specifi c IGE blood tests are indicated. Wheal size on SPT e.g. dairy products, peanuts and eggs can be a prognostic factor both for the likelihood of growing out of the Eczema and also risk of other atopic illnesses,
The definition of the word Eczema comes from a Greek word meaning “to boil out”. It is a superficial inflammatory process involving the epidermis marked by variable levels of redness, scaling, weeping and lichenification. The term is used interchangeably with atopic dermatitis.
Eczema Feature
Dr Brendan Fitzpatrick from Allergy.ie
Dr Brendan Fitzpatrick, Medical Doctor, Allegy.ie
Solpadeine Soluble Tablets (P) contain Paracetamol, Codeine Phosphate Hemihydrate and Caffeine. For the treatment of acute moderate pain not relieved by other analgesics such as paracetamol or ibuprofen alone; for symptoms of headache, including migraine, toothache, backache, common cold, influenza, menstrual pain, muscoskeletal pain. Adults and children 12 years and over: 2 tablets in water three to four times in 24 hours as required; not more frequently than once every four hours. Maximum 8 tablets in 24 hours. Children under 12 years: Not recommended. Do not take for more than 3 days without consulting a doctor. Do not take any other paracetamol or codeine containing products concurrently. Avoid excessive caffeine intake. Can cause addiction. Use for 3 days only. In case of overdose, seek immediate medical advice, even if the patient feels well. Contraindications: Lactation, acute asthma, known hypersensitivity to ingredients, known CYP2D6 ultra-rapid metabolisers, patients under 18 years who undergo tonsillectomy or adenoidectomy for obstructive sleep apnoea syndrome, rare hereditary fructose intolerance. Precautions: Caution in renal or hepatic impairment, non-cirrhotic alcoholic liver disease, obstructive bowel disorders, previous cholecystectomy, acute abdominal conditions, pregnancy, hypertension, oedema. Interaction with coumarins (including warfarin), domperidone, metoclopramide, colestyramine, monoamine-oxidase inhibitors. Side effects: anaphylaxis, bronchospasm, dependency or worsening of headache following prolonged use, dizziness, GI disturbances, hepatic dysfunction, thrombocytopenia. PA 1186/11/1. MAH: Chefaro Ireland Limited, 1st Floor, Block A, The Crescent Building, Northwood Business Park, Dublin 9. RRP (excl. VAT): 12s €4.99, 24s €7.99, 60s (GMS) €12.15. SPC: www.medicines.ie/medicine/6826/SPC/Solpadeine+Soluble+Tablets.
Always read the label. Can cause addiction. For three days use only. **IMS MAT Value Oct 2014 SOL/IRE/14-003
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30
Eczema Feature
e.g. Asthma and Rhinitis. Allergy results can change, and review and testing every two years may be indicated in the more allergic patients. Up to 70% to 80% of people grow out of Dairy and Egg allergy but only 15-20% with nut allergy.
Dietary elimination for a maximum of six weeks will normally indicate whether the Eczema is diet related. Caution must be exercised with challenging omitted foods and severely allergic patients require challenge in a hospital setting. Adrenalin injections are usually prescribed for peanut and other severe allergies, particularly if associated with Asthma.
Non IGE reactions are controversial but are worth considering with patients with some chronic medical problems particularly Eczema and digestive disorders. These reactions have been largely ignored by the profession since first becoming popular in the 1980s. However, more recent research has confirmed a variety of non-IGE reactions, particularly in the gut area and a time limited trial exclusion diet may be indicated in Eczema with an appropriate history.
IGG/food intolerance testing has become increasingly popular in recent years but has significant limitations and caution should be recommended with interpretation of the results. The presence of IGG antibodies to a food does not necessarily indicate sensitivity and may be due to regular intake. There is a relatively high incidence of both false positive and false negative results. I regularly see patients where positive test results to food have no connections to their symptoms. I believe good Allergy Practice always requires a detailed history, Allergy testing and confirmation of the results by elimination and challenge. Prolonged, unnecessary dietary restriction should always be avoided.
Seborrhoeic dermatitis is a form of eczema affecting the scalp, face, ears and sometimes chest area and 70% of patients with this condition have yeast colonisation. The role of yeast/sugar sensitivity is controversial but I do believe it can be beneficial in appropriately selected patients. Patients may have seborrhoeic dermatitis as part of a vulnerability to fungal infections, e.g. recurrent thrush, Athlete’s Foot, groin rash. Treatment of this condition
involves a full history, sometimes allergy testing and treatment with diet, probiotics, supplements and sometimes anti fungal medication. The programme can also be beneficial not only in terms of Eczema but also in terms of energy and well being.
COMPLEMENTARY MEDICINE (CM):
Food intolerances and yeast/sugar sensitivity, as above, have generally been regarded as part of CM. These are treatments largely unproven by conventional scientific methods.
There are many different types of CM and their potential use must be individually assessed.
From my experience, some Complementary Medicine treatments worth considering in Eczema are:
a. Supplements. These may include Omega 3, Vitamin D, Zinc and B Vitamins. An 8-week course of Omega 3 can improve skin texture and help with barrier function. It should not be used with anti-coagulants.
b. A course of probiotics, particularly if there is also
a history of Irritable Bowel Syndrome, yeast/sugar sensitivity or requiring regular antibiotics.
c. Herbs. A study on Chinese herbs several years ago showed some benefit in relation to Eczema but there were concerns about liver toxicity. Other suggested herbs for use include Milk Thistle (Silymarin), which is reputed to be supportive of the liver and contains anti-inflammatory and anti-oxidant properties. Patients often describe benefit from local application of Calendula cream/ointment.
d. Stress. It does not cause Eczema but can aggravate it. Help or supportive measures include breathing and relaxation techniques.
e. Acupuncture may be beneficial working through the nervous system, producing a relaxant effect and overall improvement in energy and well being.
In summary, allergy management and appropriate CM use can be very worthwhile in Eczema, either in isolation or combined with conventional treatment.
CPD 49: EPILEPSY
Pharmacy management of Epilepsy patients
60 Second SummaryEpilepsy is one of the commonest neurological disorders after stroke and it affects approximately 40,000 Irish people.
There are many causes and it is classified into different types. People with epilepsy have an increased predisposition to seizures. Seizures are purely descriptive of events and occur in epilepsy as well as other medical conditions.
Treatment is usually initiated after a second seizure because there is a 73% risk of seizure recurrence within four years of two unprovoked seizures.
There are many factors involved in the medical treatment of epilepsy and this CPD article will mainly focus on initiation of treatment, pharmacology of anti-epileptic medication (AED), tolerability, enzyme induction, therapeutic drug monitoring, drug resistant epilepsy and treatment of certain patient cohorts. A brief discussion on status epilepticus and the role of the pharmacist is also discussed.
INTRODUCTION
Epilepsy has multifactorial origins and manifestations and is made up of many types. It is a clinical diagnosis and is based on clinical history and eye witness accounts of the seizure.
Primary generalized seizures involve the whole brain and consciousness is lost. Seizures in this category include absence (patient looks blank for a few seconds and does not respond when spoken to), tonic clonic (patients stiffens, loses consciousness and convulses), tonic (patient stiffens and falls), atonic (patient has drop attacks) and myoclonic (patient has rhythmic shock like muscle jerks). Partial seizures involve only part of the brain and consciousness may be altered but not lost. Seizures in this category include simple partial seizure (wide range of symptoms depending on area involved i.e. tingling, twitching, blinking, psychic symptoms). Complex partial seizures occur when the discharge reaches midline and becomes secondarily generalized.
Seizures are purely descriptive of events i.e. disturbance of consciousness/behavior/motor function or sensation and occur in
alcohol withdrawal and hypoglycaemia as well as in epilepsy. People with epilepsy have an increased predisposition to seizures. Depending on the part of the central nervous system involved there are different effects seen. For example, if the motor cortex is involved the patient will have convulsions and if the reticular formation is involved the patient will lose consciousness. Complex seizures are those in which there is loss/altered consciousness and in simple seizures there is no loss of consciousness.
INITIATION OF TREATMENT
If a diagnosis of epilepsy is made, treatment with an anti-epileptic drug (AED) is usually recommended, especially if further seizures might cause serious morbidity or mortality. The basis for this advice is a 73% risk of seizure recurrence within four years of two unprovoked seizures1.
In some cases treatment may be justified after their first seizure if they are at a higher risk of recurrence as these patients have a slightly better long term outcome with early versus delayed treatment 2.
1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice.
2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.
3. PLAN - If I have identified a knowledge gap
- will this article satisfy those needs - or will more reading be required?
4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result? Have I identified further learning needs?
5. WHAT NEXT - At this time you may like to record your learning for future use or assessment. Follow the 4 previous steps, log and record your findings.
Published by IPN. Copies can be downloaded from www.irishpharmacytraining.ie
Disclaimer: All material published in CPD and the Pharmacy is copyright and no part of this can be used within any other publication without the permission of the publishers and author.
Biography - Paul Ryan, Community Pharmacist, O'Reilly's Pharmacy, Clonmel; General Practitioner trainee, Cork University Hospital.
Paul Ryan has spent the last nine years working in both Community Pharmacy and Hospital Pharmacy. Ryan is particularly interested in Clinical Pharmacy and, after completing a Diploma in the subject, he went on to study medicine. He is currently a GP trainee. By combining these qualifications it has allowed him to be involved in developing and delivering CPD for pharmacists in Ireland. Ryan has worked as a Clinical tutor for eight years, both in the ICCPE and in the IPU academy, as well as the UCC School of Pharmacy at postgraduate level. Ryan started working as a Peer Support Pharmacist for the IIOP in 2014.
AEDs suppress the symptoms (seizure) rather than modify the disease process (epileptogenesis) and work by preventing paroxysmal neuronal discharge without affecting normal discharge. Carbamazepine, oxcarbazepine, lamotrigine, valproate and phenytoin bind to the inactivated state of voltage gated Na channels of repetitively firing neurons thus stabilizing neuronal membranes, having a greater block in neurons that have a higher frequency in firing, thus suppressing discharge. Benzodiazepines and phenobarbitone enhance the effect of inhibitory neurotransmitters.
WHICH ANTI-EPILEPTIC DRUG TO USE FIRST?
Choice of treatment depends on seizure type, age of patient and concurrent/previously tried therapy. There are only a few class 1 trials to compare the efficacy of first line anti-epileptics. NICE has produced guidance on how to choose the correct medication3. For instance, carbamazepine and lamotrigine are recommended first-line treatment for focal seizures and sodium valproate is the recommended first-line treatment for generalised tonic–clonic (GTC) seizures (carbamazepine and lamotrigine are also used for GTC seizures). Valproate or ethosuxamide are used in absence seizures and, for myoclonic seizures valproate is used. Valproate and lamotrigine are often used if there is any doubt of seizure type. Formulations of anti-epileptics are not interchangeable and generic substitution should not be employed.
TOLERABILITY AND SAFETY OF DRUGS IN NEW ONSET EPILEPSY
As the efficacy of many first line anti-epileptics in new onset epilepsy is similar, the tolerability and safety become important considerations when choosing treatment. Sedation and dizziness are common complaints when starting anti-epileptic drugs but usually resolve with time. Sedation is less with the newer anti-
epileptics. Valproate can cause weight gain. Carbamazepine can cause bone marrow failure so be alert for symptoms of anaemia, bruising and infection. Lamotrigine can cause a rash in 12% of patients, typically within the first 8 weeks of treatment, leading to withdrawal in 3% of patients. To reduce the risk of side effects, the doses should be started low and slowly titrated upwards (usually symptom led) and, if seizures are still taking place titrate up to maximum dose.
ENZYME INDUCTION
Strong hepatic enzyme inducers include phenytoin, phenobarbitone and primidone and weak hepatic enzyme inducers include carbamazepine, oxcarbazepine and topiramate. People on long term enzyme induction should be screened for osteoporosis and sexual dysfunction. Over the counter dietary supplements or herbal preparations like Gingko Biloba or St Johns wort can interact with anti-epileptic medications that are metabolized by the liver.
THERAPEUTIC DRUG MONITORING
There is no evidence that routine blood level monitoring is beneficial unless to confirm suspected non adherence, evaluate unexplained toxicity or evaluate uncontrolled seizures in individual cases 4. If there is a previous blood level to compare at a time of good control, a level may help in this circumstance to see whether there has been a significant drop at a time of poor seizure control. The general rule is to ‘treat the patient not the level’. Many patients obtain freedom from seizures with concentrations below the therapeutic range while some tolerate and require concentrations above the range. Seizure control and development of adverse effects usually determine the dose. An exception to this is phenytoin, for which monitoring is strongly recommended, particularly at concentrations above 20mg/L because of the non-linear saturation dose kinetics (in which small changes in dose lead to large rises in plasma level) 4.
DRUG RESISTANT EPILEPSY
Half of patients with new onset focal or generalized seizures as internationally defined 5 become free from seizures while taking the first appropriately selected anti epileptic drug 6. 70-80% of patients with new onset epilepsy have complete seizure control with anti-epileptics available today; however up to 30% of patients have drug resistant epilepsy 7. Any patient in whom at least 2 trials of adequately selected and dosed anti-epileptic drugs have not brought sustained remission fulfils the ILAE criteria for drug resistant epilepsy 8. The mechanisms underlying drug resistant epilepsy are still not fully understood 9. It is interesting that a history of depression and a high frequency of seizures before treatment onset have been associated with drug resistance10. There is no class 1 evidence to show superior efficacy of any AED for treating drug resistant epilepsy11.
WHAT IF THE FIRST DRUG FAILS TO INDUCE SEIZURE REMISSION?
Two main options exist for patients who continue to have seizures despite taking the first chosen anti-epileptic; combination therapy (add-on therapy) or alternative monotherapy (substitution) 12. Most doctors prefer add on treatment with small increases in dose because it prevents the possibility of breakthrough seizures after discontinuation of the first drug. Substitution is preferable for patients who suffer intolerable side effects from the first drug. There is no evidence that it is more beneficial to take more than two drugs at any time, therefore keep drug combinations to two maximum where possible.
TREATMENT OF CERTAIN POPULATION COHORTS
Older people
As there are lower glomerular filtration rates in this patient cohort, the doses of renally excreted drugs should be reduced. There is also a change in body fat, albumin and cytochrome P450 and hyponatraemia secondary to oxcarbazepine may be more common 13. Older people are also more likely to be on medication which increases the possibility of drug interactions. Mono therapy with an anti-epileptic that is well tolerated and has low possibility of drug interactions, such as lamotrigine, gabapentin 14 or low dose topiramate, is preferable.
Women
There is a higher incidence of bone fracture in people with epilepsy (particularly women) compared to the general population because they can break a bone during a seizure, as well as the use of anti-epileptic drugs (especially enzyme inducing ones) which increase the risk 15. Enzyme inducing drugs were shown to independently increase the risk of fracture in the Womens Health Initiative study 16. The
Womens Health Initiative study concluded that attention to fall prevention is particularly important in postmenopausal women who use anti-epileptic medication. Anti-epileptic medication - and in particular enzyme inducing ones - have been shown to decrease bone mineral density and alter bone metabolism. One mechanism is by inducing cytochrome P, which accelerates metabolism of vitamin D to polar inactive metabolites17. Risedronate plus calcium and vitamin D has been shown to prevent the occurrence of new fractures in males with a higher risk of fractures18.
Pregnant women and neonates
Two out of three women with epilepsy who become pregnant remain seizure free throughout pregnancy. However, anti-epileptic drug dosages may need to be adjusted, particularly if seizures occur in the first trimester. A woman who is planning to get pregnant should be given accurate information with regard to the risks of AEDs and pregnancy, particularly the possible effects on the unborn child. As there is an increased glomerular filtration rate during pregnancy, the clearance of lamotrigine and possibly levetiracetam,
topiramate and oxcarbazepine will be increased and dose adjustment will have to be made to reduce the risk of breakthrough seizures19 .The risk of continued use of sodium valproate to the unborn child especially should be discussed, being aware that higher doses of sodium valproate (more than 800mg/day) and polytherapy, particularly with sodium valproate, are associated with higher risk. 5mg of folic acid should be given to all women of child bearing potential. There is limited information on the risks to the unborn child associated with newer drugs.
BREAST MILK
Primidone and levetiracetam pass into breast milk in amounts that may be clinically important unlike valproate, phenytoin, phenobarbital and carbamazepine 20.
PATIENTS WITH CO-MORBIDITIES
There is double the lifetime community based prevalence of depression, suicidal ideation and generalized anxiety disorder in patients with epilepsy compared to the general population 21. This is very significant as both depression and anxiety affect the
quality of life and lead to an increased suicide rate. Before considering starting a patient on an anti-depressant, look to see if they are on phenobarbital, vigabatrin, tiagabine, clobazam, topiramate or levetiracetam as these can all induce depressive symptoms in patients with epilepsy. It must also be taken into consideration that, if carbamazepine, valproate or lamotrigine are discontinued it may precipitate depression as these all have mood stabilizing properties. Sertraline, fluoxetine and citalopram are 3 antidepressants where there is limited evidence of benefit for depressed patients with epilepsy 22. As there are minor pharmacokinetic interactions with escitalopram and citalopram these should be considered first line drugs followed by sertraline. Fluoxetine and paroxetine interfere with CYP450 so, when these are used the anti-epileptic drug doses may need to be adjusted.
STATUS EPILEPTICUS
The International League Against Epilepsy (ILAE) defined status epilepticus more than 20 years ago as being a single epileptic seizure of >30 minutes duration or a series of epileptic seizures during which function is not regained
between ictal events in a 30 minute period 23. Because of the clinical urgency in treating generalized convulsive status epilepticus (GCSE), however, a 30 minute defi nition is neither practical nor appropriate in clinical practice. Once seizures have continued for more than a few minutes, treatment should begin and an ambulance should be called. Considering the need for rapid evaluation and intervention in GCSE, an accepted operational defi nition of status epilepticus is ≥5 minutes of continuous seizures, or ≥2 discrete seizures between which there is incomplete recovery of consciousness. Buccal midazolam or rectal diazepam are used fi rst line. In early status epilepticus buccal midazolam is a key option as a randomized controlled trial showed that it achieved seizure cessation in 8 minutes compared with 15 minutes for rectal diazepam, with no difference in the rates of respiratory depression 24. In established status, epilepticus options include intravenous valproate, levetiracetam, phenytoin and phenobarbital. In refractory status, epilepticus midazolam, thiopentone and propofol are possible options.
STOPPING ANTI-EPILEPTICS
The decision to stop anti-epileptics should be based on the risk of seizure recurrence after discontinuation (which is twice as high overall in the 2 years after discontinuation) and continuing to take them. The risk of recurrence of seizures when patients stop taking anti-epileptics is as high as 34% with a wide range of 12-66% 25. If the patient is seizure-free for more than 2 years, this implies a 60% chance of persistent remission in certain epilepsies. Factors which favour this include no previous unsuccessful attempts at withdrawal, control easily achieved on a low dose of 1 drug, normal neurological examination and electroencephalogram, primary generalized epilepsy (except juvenile myoclonic epilepsy) and benign syndromes. There is a greater risk of seizure recurrence off anti-epileptic drugs if the patient is over 16 years, on more than 1 anti-epileptic, previously had seizures after starting drug treatment, history of generalized tonic-clonic seizures or history of myoclonic seizures. The revised ILAE defi nition of epilepsy states that ‘Epilepsy is considered to be resolved for individuals who either had an age dependent epilepsy syndrome but are now past the applicable age or those who remained seizure-free for the last 10 years and off anti-seizure medications for at least the last 5 years’.
Factors to be taken into account when a patient is being counselled about discontinuation include driving, pregnancy, work and family. It is also worth considering that, if other seizures were to occur, it may cause embarrassment for the patient as well as causing loss of the drivers’ license or rarely seizure related death. If the anti-epileptic drug was to be restarted, this does not guarantee immediate or sustained resumption of seizure control. The patient might still be anxious to discontinue due to drug related side effects and drug interactions and, if so, a slow tapering discontinuing schedule
may be undertaken. Antiepileptic drugs are continued for at least 1-2 years after epilepsy surgery. Use of these drugs in this setting led to the old name anti-convulsants (convulsions after surgery).
ROLE OF THE PHARMACIST
It is very important that good communication exists between all healthcare professionals involved, as well as the patient and their carers so the treatment plans are clear. Written evidence-based information about epilepsy should be given to the patients. We, as pharmacists are ideally placed to identify non-adherence to medication as well as identifying medication-related side effects. We can also advise on the use of non-prescribed medications and supplements, as well as advising doctors on the best treatment available for a particular patient. When reviewing prescriptions, look at the dose and see if there have been any changes in dose, is the prescription slow release or plain? Be mindful of drug interactions and remember generic substitution is not advised. Factors involved in patient counselling include side effects, compliance (need for memory aids), work and pregnancy.
In summary, pharmacists have a huge role in the effective management of epilepsy and, as patient advocates, through clear communication between all the parties involved.
Sources of information:
Websites
www.epilepsy.iewww.epilepsyresearch.org.uk
www.epilepsy.org.uk
REFERENCES:1. Hauser WA, Rich SS, Lee JR, Annegers JF, Anderson VE. Risk of recurrent seizures after two unprovoked seizures. N Engl J Med 1998;338:429-34.
2. Kim LG, Johnson TL, Marson AG, Chadwick DW; MRC MESS Study group.Prediction of risk of seizure recurrence after a single seizure and early epilepsy: further results from the mess trial. Lancet Neurol 2006;5:317-22.
3. NICE. The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care. January 2012. NICE CG137.
4. Schmidt D. Drug treatment of epilepsy: options and limitations. Epilepsy Behav 2009;15:56-65.
5. Commission on Classifi cation and Terminology of the International League Against Epilepsy. Proposal for revised clinical and electroencephalographic classifi cation of epileptic seizures. Epilepsia 1981;22:489-501.
6. Sillanpää M, Schmidt D. Natural history of treated childhood-onset epilepsy: prospective, long-term population-based study. Brain 2006;129:617-24.
7. Cockerell OC, Johnson AL, Sander JW, Shorvon SD. Prognosis of epilepsy:a review and further analysis of the fi rst nine years of the British National General Practice Study of Epilepsy, a
8. Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Hauser WA, Mathern G, et al. Defi nition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia 2010;51:1069-77.
9. Löscher W, Brandt C. Prevention or modifi cation of epileptogenesis after brain insults: experimental approaches and translational research. Pharmacol Rev 2010;62:668-700.
10. Hitiris N, Mohanraj R, Norrie J, Sills GJ, Brodie MJ. Predictors of pharmacoresistant epilepsy. Epilepsy Res 2007;75:192-6.
11. Löscher W, Schmidt D. Modern antiepileptic drug development has failed to deliver: ways out of the current dilemma. Epilepsia 2011;52:657-78.
12. Karceski S, Morrell MJ, Carpenter D. Treatment of epilepsy in adults: expert opinion, 2005. Epilepsy Behav 2005;7:S1-64.
13. Robertson MM, Trimble MR. The treatment of depression in patients with epilepsy. A double-blind trial. J Affect Disord 1985;9:127-36.
14. Rowan AJ, Ramsay RE, Collins JF, Pryor F, Boardman KD, Uthman BM, et al. New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine. Neurology 2005;64:1868-73.
15. Pack A. Bone health in people with epilepsy: is it impaired and what are the risk factors? Seizure 2008;17:181-6.
16. Carbone LD, Johnson KC, Robbins J, Larson JC, Curb JD, Watson K, et al. Antiepileptic drug use, falls, fractures, and BMD in postmenopausal women: fi ndings from the women’s health initiative (WHI). J Bone Miner Res 2010;25:873-81.
17. Brodie MJ, Mintzer S, Pack AM, Gidal BE, Vecht CJ, Schmidt D. Enzyme induction with antiepileptic drugs: cause for concern? Epilepsia 2013;54:11-27.
18. Lazzari AA, Dussault PM, Thakore-James M, Gagnon D, Baker E, Davis SA, et al. Prevention of bone loss and vertebral fractures in patients with chronic epilepsy—antiepileptic drug and osteoporosis prevention trial. Epilepsia 2013; published online 6 Sep.
19. Battino D, Tomson T, Bonizzoni E, Craig J, Lindhout D, Sabers A, et al; EURAP Study Group. Seizure control and treatment changes in pregnancy: Observations from the EURAP epilepsy pregnancy registry. Epilepsia 2013;54:1621-7.
20. Meador KJ, Loring DW. Risks of in utero exposure to valproate. JAMA 2013;309:1730-1
21. Tellez-Zenteno JF, Patten SB, Jette N, Williams J, Wiebe S. Psychiatric comorbidity in epilepsy: a population-based analysis. Epilepsia 2007;48:2336-44.
22. Noe KH, Locke DE, Sirven JI. Treatment of depression in patients with epilepsy. Curr Treat Options Neurol 2011;13:371-9.
23. Guidelines for epidemiologic studies on epilepsy. Commission on Epidemiology and Prognosis, International League Against Epilepsy. Epilepsia. 1993;34(4):592.
24. McIntyre J, Robertson S, Norris E, Appleton R, Whitehouse WP, Phillips B, et al. Safety and effi cacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. Lancet 2005;366:205-10.
25. Schmidt D, Löscher W. Uncontrolled epilepsy following discontinuation of antiepileptic drugs in seizure-free patients: a review of current clinical experience. Acta Neurol Scand 2005;111:291-300.
Myth.
Categorically NO. They are licensed for constipation and do not cause weight loss.
Taking a laxative where there is no need for constipation relief will merely result in the loss of water, salts and nothing more.
“Laxatives help with weight loss”10
There are many myths and misconceptions around the use of laxatives. Over the next few months Dulcolax will provide some simple advice on each of the most common myths and misconceptions.
Dulcolax® 5mg Gastro-intestinal TabletsOffers predictable overnight relief. It has a comfort coating which means it is gentle on the stomach and only works where its needed. Contains Bisacodyl, always read the label
Dulcolax® 100ml and 300ml Pico LiquidFor people who prefer a liquid. It is sugar free, fruit flavored and offers predictable overnight relief. Contains Sodium picosulfate always read the label
Dulcolax® 10mg and 5mg SuppositoriesFor people who need fast relief from their symptoms. They get to work in about 20 minutes (usual range 10-30 minutes), giving quick relief from constipation. Contains Bisacodyl, always read the label
Find out more about us and read what constipation sufferers think and feel at www.letstalkconstipation.ie the constipation experts
36
Awards2015The Irish Pharmacy
Ten reasons why entering awards are good for your pharmacy
Awards are one of the most powerful and cost-effective marketing tools and winning a prestigious Irish Pharmacy Award has been proven to help your pharmacy business to stand out from the crowd, send a positive message to your existing customers and attract new business.
1. BenchmarkingThe application process for entering any awards can often force you to look at your business from a different perspective and compare yourself to your competitors.
You’ll need to make sure that you stand out from the competition whether that’s through innovation, diversity, growth, customer service, investment in people and strategic thinking. This will help you think about ways you could be doing things better and identify areas for improvement.
2. Free marketingThe Irish Pharmacy Awards can be overlooked in your marketing toolbox. Just being shortlisted can improve brand awareness and promote your pharmacy to new customers.
Maximise PR exposure and update your marketing materials or window with the award logo - Make sure that people know what your business has achieved.
3. Increased credibilityAn Irish Pharmacy Award win, short-listing or nomination can act as a 3rd party endorsement for your pharmacy. A win can give a seal of approval to your activities and is a sign of quality for your customers.
It can also help with relationships with suppliers. It’s a great way of differentiating your company from other pharmacies in your area and will send out positive signals to customers.
4. Employee motivationAwards recognise the hard work and achievements of your employees so winning one can help boost staff morale and improve motivation.
Employees are focused on what’s great about the company they work for and can feel proud to be a part of it. Attending the ceremony as a team can yield networking opportunities as well as being a chance to celebrate your achievement.
5. Attract talentThe Irish Pharmacy Awards showcase you as a successful pharmacy business to work for. Being part of awards can attract the talent you need to push your pharmacy forward and increase employee morale. You will be likely to attract top quality team members as a result of your awards success.
6. Free to enter – Your pharmacy business resources are important. In the case of the Irish Pharmacy Awards this shouldn’t be an expensive or laborious process.
7. Impressive trophySuccessful fi nalists are awarded an impressive certifi cate and winners a trophy, which can be displayed within the pharmacy, instilling pride in your staff and favourable impressions on visiting customers, both existing and new.
8. Raise your company profi leBeing part of the Irish Pharmacy Awards can signifi cantly raise your company profi le and gain you respect fromQ your peers. In addition, being nominated for an award can help identify your business as expert in the chosen category.
9. Impress potential investorsIf you aim to grow your business, recognition in the awards can help impress potential investors.
10. Network with fellow pharmacy leadersAttending the awards dinner and subsequent events gives you the opportunity to network with other pharmacy leaders and professionals.
Jonathon Morrissey of Marrons Pharmacy won two awards at the 2014 Irish Pharmacy Awards and refl ects on how this has helped him to enhance their business name within the communities they serve.
“It defi nitely helped us to instantly deliver a feeling of presence to the customers that didn’t know us and helped to inspire trust in the longevity of the business.
“Marrons continues to thrive and,
once we have reached some more business milestones, I hope to be able to enter the awards again in the future.” Jonathon goes on to say “entering the Irish Pharmacy Awards was easy, straightforward and free, which is very rare for awards these days.”
Jonathon Morrissey continues, “I think the best thing about winning the Irish Pharmacy awards is that it gave us additional exposure within the pharmacy market, so people who may not have known about us and the services we can offer, suddenly come in to contact with you. It’s a great way to build awareness.
“Winning has changed a few things, nothing too drastic, but what it has done is give us external validation for some of the hard work and effort that the team put into the business on a day to day basis, so when other people come into the pharmacy there’s instantly something else that’s vouching for the qualities that you have as a business, so it’s a really great way to make a good impression.”
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
LloydsPharmacy Limerick team - 2014 OTC Retailers of the Year
Unilever OTC Retailer of the Year Award 2015
* This Award may be entered though individual application or nomination for those pharmacy businesses with more than 5 stores throughout Ireland
Customer purchases of OTC products have consistently risen, for many reasons. The convenience of treating a condition with an OTC product is appealing to the typically busy person, who seeks to avoid a lengthy and expensive GP visit in favour of meeting the demands of home and work. In addition, patients in the information age have an increased level of awareness about health.
The over-the-counter market continues to thrive as manufacturers continue to think of new promotional and packaging ideas and as the general public take a greater interest in their own health and wellbeing. Pharmacies are increasingly witnessing heightened footfall as GP visits decrease.
Pharmacy staff are the focal point for helping customers select appropriate OTC medicines, suggest diagnostic testing and accessory products and must be aware of when to refer individuals to the pharmacist. Knowledge of the market is essential; seasonal products and accessories; the use of displays and front of shop expertise. and judges will want evidence of excellent merchandising strategies.
JUDGES WILL BE LOOKING FOR:
Demonstration of identifying key promotional opportunities to add value for the customer such as health promotion events and displays
A showing of continuous working with manufacturers and suppliers to plan yearly promotional calendars to meet pharmacy profi t goals
Implementation of innovative strategies to competitive pricing
Examples of education for staff on new products and convenyance to customers as to effi cacy and usage
Awards2015The Irish Pharmacy
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
37
Linda O'Brien and Fionnuala Moloney, LloydsPharmacy, Limerick - winners of the
2014 OTC Retailer of the Year
38
Actavis Business Development (Independent) Award 2015
* Open to all pharmacies with less than 3 stores
The Business Development (Independent) Award provides the opportunity for pharmacy businesses that have grown to receive recognition for their achievements.
The winner of this award will have demonstrated how they have grown the overall business through innovation and planned development, supported by strategic investment. This may, for example, have been achieved by the implementation of a new strategy, the launch of a new product or service or through a successful merger or acquisition.
The judges will be looking at how the development has been refl ected in increased turnover and employment and, most importantly, in enhanced profi tability. They will also focus on sustainability and the long term goals and strategy that have been put in place.
JUDGES WILL BE LOOKING FOR:
Clear demonstration of an identifi ed need and personal rationale along with details of the process of implementation from concept to design, planning and results
Evidence will be displayed for plans for further research and development
Evidence of a sound business plan, sales and marketing strategies
Strong leadership skills with the ability to drive the business forward
Innovation and ambition
Awards2015The Irish Pharmacy
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
Jonathan Morrissey, Marrons Pharmacy, 2014 winners, Actavis Business Development Award
Tailored to You
Take Control with ActavisSimplifying your business and maximising profitability is fundamental to Pharmacy growth. That is why, at Actavis, we have launched a new innovative purchasing model for customers called the ‘Accumulator’.
The ‘Accumulator’ is a simple pack replacement scheme offering transparency and consistency together with excellent customer service.
The ‘Accumulator’ puts you in the driving seat, offering the best margins and excellent value across our portfolio which will allow you to develop your business with confidence.
THE ACTAVIS ‘ACCUMULATOR’ GIVES YOU MORE:
Transparency – of Pricing, Margins and Invoicing.
Consistency – of Supply, Purchasing and Customer Service.
Value – across Generics, OTC and Branded Medicine.
Control – over your Purchasing, your Profits and your Business.
Actavis and You – The partnership that adds up.
Contact us at 021 461 9040 or on www.actavis.ie to see how the ‘Accumulator’ can be put to work for you.
Date of Preparation: April 2014. NA-019-01.
Tailored to You
Take Control with ActavisSimplifying your business and maximising profitability is fundamental to Pharmacy growth. That is why, at Actavis, we have launched a new innovative purchasing model for customers called the ‘Accumulator’.
The ‘Accumulator’ is a simple pack replacement scheme offering transparency and consistency together with excellent customer service.
The ‘Accumulator’ puts you in the driving seat, offering the best margins and excellent value across our portfolio which will allow you to develop your business with confidence.
THE ACTAVIS ‘ACCUMULATOR’ GIVES YOU MORE:
Transparency – of Pricing, Margins and Invoicing.
Consistency – of Supply, Purchasing and Customer Service.
Value – across Generics, OTC and Branded Medicine.
Control – over your Purchasing, your Profits and your Business.
Actavis and You – The partnership that adds up.
Contact us at 021 461 9040 or on www.actavis.ie to see how the ‘Accumulator’ can be put to work for you.
Date of Preparation: April 2014. NA-019-01.
40
Pinewood Healthcare Community Pharmacist of the Year Award 2015
The Pharmacist of the Award recognises a community pharmacist who demonstrates leadership and exemplifi es the evolution of the pharmacy profession toward an expanded role in health care.
The winner will demonstrate signifi cant contributions to the pharmacy industry overall resulting in meaningful improvements in the quality of patient care and improved delivery models and pharmacy’s role on the health care team.
Applications are invited from both the independent and chain sectors.
JUDGES WILL BE LOOKING FOR:
Evidence of long-term, consistent dedication and outstanding achievements that have led to the advancement of the profession of pharmacy and public health
Evidence of a large variety of skills, attributes and accomplishments
Evidence of an individual strong in character, cumulative professional accomplishments and the ability to properly represent and model what pharmacy as a profession encompasses
Evidence of an understanding the goals of pharmacy, and signifi cantly contributing to how these goals may be achieved
Awards2015The Irish Pharmacy
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
Roisin Mulhern, Healthwise Pharmacy, Community Pharmacist of the Year 2014 with Cormac Kearney,
Key Account Manager, Pinewood Healthcare
Awards2015The Irish Pharmacy
McLernon Computers Innovation and Service
Development (Independent) Award 2015
* Open to all pharmacies with less than 3 stores
The McLernon Computers Innovation & Service Development Award’s principal aim is to reward innovation within community pharmacy. The judging panel will be looking for ways in which a project is both innovative and successful.
This Award identifi es individuals and teams working within independent community pharmacy in Ireland whose ideas or inventions have, or could lead to, improvement in the patient experience in all areas of care throughout their community.
Applications are sought from those demonstrating clear enthusiasm and commitment to the enhancement of community pharmacy in Ireland, exceptional quality above and beyond what is expected and an ability to overcome challenges in pursuit of goals.
JUDGES WILL BE LOOKING FOR:
Activities that may involve pioneering new models or systems that improve pharmacists’ impact as members of the healthcare team; patient safety and outcomes; patient care in general and other professional development
Development of a system or tool for pharmacy that will directly or immediately impact patient care or the profession and/or serve as an example or template for other pharmacy professionals to follow
Measurable benefi ts of your initiative. Please use fi nancial data wherever possible (percentages, rations, graphic images etc.), as well as other statistics to show how your project has bought added value, profi ts, customer satisfaction improvements, productivity increases or any other benefi t relevant to this award category
42
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
Fergus Brennan, Brennans Pharmacy Group, 2013 winners of the McLernon Computers Innovation & Service Development (Independent) Award
43
Clonmel Healthcare Innovation and Service Development
(Chain) Award 2015
* Open to all pharmacies with more than 3 stores
The Innovation and Service Development Award is defi ned as the successful introduction of an idea, method or device that makes a genuine difference or positive change for the pharmacy or patients, or both.
The Innovation and Service Development Award will be presented to an individual or team from a chain pharmacy (more than 3 stores) who has demonstrated an innovative pharmacy practice programme, resulting in improved patient care or safety, advancement of the profession enhanced pharmacy systems or other professional development.
This Award will go to those that can best demonstrate an innovation or innovative approach that has created competitive advantage, contributed to growth, transformed the organisation, improved overall fi nancial advantage or achieved operational excellence.
JUDGES WILL BE LOOKING FOR:
Activities that may involve pioneering new models or systems that improve pharmacists' impact as members of the health care team; patient safety and outcomes; patient care in general and other professional development
A system or tool for pharmacy professionals that will directly or immediately impact patient care or the profession and/or serve as an example or template for other pharmacy professionals to follow
Cumulative achievements or a single outstanding programme/project completed or carried out over the past twelve months
Awards2015The Irish Pharmacy
43
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
Michael Brogan, Molloys Pharmacy, Ballina, 2014 winners, Clonmel Healthcare Innovation & Service Development (Chain) Award with Martin Gallagher,
Director of Marketing, Clonmel Healthcare
Awards2015The Irish Pharmacy
PharmaConex Young Pharmacist
of the Year Award 2015
The Young Pharmacist of the Year Award recognises rising talent – those individuals who despite being in the early stages of their pharmacy careers are already demonstrating that they can make a difference to the pharmacy profession and the companies for whom they work and the communities they serve.
This award is open to pharmacists aged up to 30 - at the date of entry submission - who are working within any pharmacy where their involvement has been greater than six months. It is the individual qualities that will be evaluated, rather than those of any of the projects worked on.
JUDGES WILL BE LOOKING FOR:
Judges will want to see effective communication skills with both staff and customers
Demonstration of a commitment to mentoring or other leadership activities
Operation within their own pharmacy liaising with key staff members and management and developing key communication skills
A dedication and commitment to furthering the profession into the future
44
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
Sarah Marshall, O'Sullivans Pharmacy,2014 Young Pharmacist of the Year
PharmaConex Young Pharmacist
of the Year Award 2015
* Open to all pharmacies with more than 3 stores
The Business Development (Chain) Award provides the opportunity for pharmacy businesses that have grown to receive recognition for their achievements.
This Award strives to recognise pharmacies who have worked collaboratively on a project or in the general workings of the pharmacy and can demonstrate a signifi cant contribution to either patient care, business growth or the local community.
The winning pharmacy will be able to demonstrate their ability to deliver clear benefi ts through working together effectively, and effi ciently.
The judges will be looking for those who encourage and support each other and those who have collectively demonstrated innovation and forward thinking.
The judges will be looking at how the development has been refl ected in increased turnover and employment and, most importantly, in enhanced profi tability. They will also focus on sustainability and the long term goals and strategy that have been put in place.
JUDGES WILL BE LOOKING FOR:
Clear demonstration of an identifi ed need and personal rationale along with details of the process of implementation from concept to design, planning and results
Evidence will be displayed for plans for further research and development
Evidence of a sound business plan, sales and marketing strategies
Strong leadership skills with the ability to drive the business forward
Innovation and ambition
Awards2015The Irish Pharmacy
45
KRKA Business Development (Chain) Award 2015
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
Linda O'Connor, Care Pharmacy, Skerries - 2014 winner receives her Award from Paul Neill,
General Manager, KRKA Pharmaceuticals Ireland
Awards2015The Irish Pharmacy
Reckitt Benckiser Nurofen for Children Baby Health
Pharmacy of the Year 2015
This is the second year of this exceedingly popular award which celebrates the application of innovation and dedication within the children/baby market in pharmacy. It will recognise an outstanding pharmacy store, project or initiative where creative thinking, sound research and team working have combined to achieve real service development in this specifi c area.
This award recognises excellence and innovation in the provision of children/baby care and will give recognition to a pharmacy which has demonstrated an exemplary forward-looking and innovative approach to provision of services in this fi eld.
Judges will be looking for the store, or team that have pioneered an initiative providing an excellent, compassionate standard of service within the children/baby market to this patient group.
It might be a model that ensures a high level of continuity of care in this area, or a unique way of working or providing care to this population.
JUDGES WILL BE LOOKING FOR:
Clear demonstration of an identifi ed need and personal rationale along with details of the process of implementation from concept to design, planning and results
Evidence will be displayed for plans for further research and development
Evidence of the process by which the project was developed and implemented
Evidence of impact on women and families
46
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
James Cassidy, Heathwise Pharmacy Group, 2014 winners of the Reckitt Benckiser Nurofen for Children Baby Health Pharmacy Award
THE INDEPENDENT VOICE OF PHARMACY
Irish Pharmacy NewsPharmacy Representative
of the Year Award 2015
The Irish Pharmacy News Pharmacy Representative of the Year Award offers pharmacy sales professional sales the opportunity to showcase their skills and to benchmark those skills against other top sales representatives.
Critical to this award is the central role of the customers. This Award serves to recognise those who have displayed success in terms of sales, training, recruitment, customer service, product development or other areas of business development. Entries should demonstrate an innovative approach to creating new business, and outline the timescales, objectives and results of the initiative.
The Pharmacy Sales Representative of the Year is someone who really goes the extra mile when it comes to their customers. They are passionate about their role and enjoy having a great working relationship with all of their customers.
JUDGES WILL BE LOOKING FOR:
Evidence of the individual's commitment to excellence
Evidence of strong customer relationships and a comprehensive understanding their needs
Meeting and exceeding client wants and deadlines
A consistent and successful sales record
Evidence of strong leadership and presentation skills
Clear understanding of their market and competitive landscape
Awards2015The Irish Pharmacy
47
Reckitt Benckiser Nurofen for Children Baby Health
Pharmacy of the Year 2015
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
Diane Owens, Johnson & Johnson, 2014 IPN Pharmacy Representative of the Year
Awards2015The Irish Pharmacy
Smoking Cessation Project of the Year Award 2015
This is a brand new Award category for 2015 and is aimed at both pharmacy individuals and teams with an interest helping others develop a healthier lifestyle by stopping smoking.
Through innovative methods the recipients of this award will have increased their knowledge and understanding of why people smoke, the personal and social consequences of this and how individuals can be helped and supported to stop smoking through their local pharmacy.
Applications to this award category may be able to demonstrate a multidisciplinary approach to smoking cessation, development of a new way of working within this fi eld or an innovative smoking cessation service that links into developing a clinical service that can be rolled out across other pharmacies in Ireland.
JUDGES WILL BE LOOKING FOR:
Those who can display an understanding of the factors that result in why people smoke along with the personal and social consequences
Evidence of providing help and support to the individual with regard to smoking cessation
Cumulative achievements or a single outstanding programme/project completed or carried out over the past twelve months
Development of a service or technique that has refi ned or changed clinical practice within the pharmacy
48
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
This Award recognises community pharmacy’s commitment to tackling health inequalities and serves to reward achievement in the development and implementation of health promotion and community wellbeing strategies and initiatives.
It is designed to encourage excellence in the production and dissemination of accessible, well-designed and clinically balanced patient support.
The Award will be presented to the team or individual who can demonstrate a signifi cant positive impact on the experience of those who use pharmacy services. This may be through campaigns, promotions or initiatives which have identifi ed a need within the community to address certain health issues.
JUDGES WILL BE LOOKING FOR:
Activities that may involve pioneering new models or systems that improve pharmacists' impact as members of the health care team; patient safety and outcomes; patient care in general and other professional development
A system or tool for pharmacy professionals that will directly or immediately impact patient care or the profession and/or serve as an example or template for other pharmacy professionals to follow
Cumulative achievements or a single outstanding programme/project completed or carried out over the past twelve months
Awards2015The Irish Pharmacy
Smoking Cessation Project of the Year Award 2015
49
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
Jonathan Morrissey, Marrons Pharmacy, winners of the 2014 GSK Health Promotion
Award with Alan Downey, Commercial Operations Manager, GSK
Awards2015The Irish Pharmacy
Counter Assistant of the Year Award 2015
Outstanding customer care may be just what the doctor ordered, but more importantly it is the pivotal aspect of any successful pharmacy.
To this end counter assistants are the crucial interface between customers and the pharmacist and they carry out their daily work duties with the ultimate goal of effectively meeting the needs of their customers.
The Counter Assistant of the Year Award recognises excellence in knowledge and service to retail customers. Nominations for the category can be made through self-nomination, by colleagues or by pharmacy business owners.
Judges will be looking to reward outstanding counter assistants, recognising those who go above and beyond their job description and make a real difference to their local community.
JUDGES WILL BE LOOKING FOR:
Evidence of the individual's contribution to the pharmacy business and impact on patient care
Levels of excellence displayed above and beyond that expected from a counter assistant role
Initiatives or innovations that the individual has established or been involved with
Clear evidence of team working and excellent communication between the individual, their peers/colleagues and their patients and local community
50
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
Sandra Finlay, Rose Finlay Pharmacy - 2014 Sanofi Counter Assistant of the Year
IMS Health Superintendent Pharmacist of the Year Award 2015
This is a new Award for 2015. Superintendent pharmacists have overall responsibility for setting out the standards and policies for the provision of pharmacy services by their organisations. The role of superintendent pharmacist is a key position carrying full time responsibility and accountability.
This Award will be looking to recognise those individuals who are serving as key drivers for the implementation of enhanced and excellent pharmacy care within the community they serve. Judges will be looking for applications from those that are focused on establishing a framework for achievement of a high quality, safe and consistent service for the benefi ts of the patient, as well as facilitating the development of the professional role of the pharmacist.
JUDGES WILL BE LOOKING FOR:
Applications are invited from independent and multiple Superintendent Pharmacists who can demonstrate one or more of the following:
Understanding patient needs when delivering healthcare in the community
Examples of great patient experience and care
Best practice in delivering professional services and patient reviews
Encouragement of staff education in patient health and wellbeing advice
Strong leadership skills with the ability to drive the business forward
Awards2015The Irish Pharmacy
Counter Assistant of the Year Award 2015
51
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
This is the second year of this Award category, which was hugely popular in 2014.
It is evident that pharmacy technicians are playing an increasingly important supporting role as pharmacists are increasingly spending more time with patient consultations and engaging local stakeholders.
The shift in emphasis from dispensing to healthcare provision has meant that the wider pharmacy team has to pull together – pharmacy technicians capture the essence of this in everything that they do. This Award will recognise the winner’s important contribution to the community pharmacy technician profession. Applications are invited from both the independent and chain sectors. The judges will be looking for those who can demonstrate promotion of the role of the Pharmacy Technician and those who continue to champion excellence through forward thinking and innovation.
The winners’ achievements will be an inspiration to those pursuing innovative practice; to those striving to raise standards; and to pharmacists who, through their professionalism, provide models for others within pharmacy.
JUDGES WILL BE LOOKING FOR:
Evidence of long-term, consistent dedication and outstanding achievements that have led to the advancement of the profession of pharmacy and public health
• Evidence of a large variety of skills, attributes and accomplishments
• Evidence of an individual strong in character, cumulative professional accomplishments and the ability to properly represent and model what pharmacy technicians as a profession encompasses
• Evidence of an understanding the goals of pharmacy, and signifi cantly contributing to how these goals may be achieved
52
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
Sinead Casey, Molloys Pharmacy - Highly Commended and Kirstie Kilpatrick, Winner - 2014 Community Pharmacy Technician of the Year
Johnson & Johnson Community Pharmacy Team of the Year
Award 2015
There are many key elements to building a productive team, including communication and co-operation. Good communication means everyone is aware of their own responsibilities and what the team's goals are whilst co-operation leads to increased productivity.
A team that excels is the one who, together, endlessly work to improve their efforts. They comprehend the importance of on-going improvements and how this helps support the overall objectives of the department.
The Award is open to any community pharmacy team with a minimum of three team members.
JUDGES WILL BE LOOKING FOR:
Judges will want to see effective communication skills with both staff and customers
Demonstration of a commitment to mentoring or other leadership activities
Operation within their own pharmacy liaising with key staff members and management and developing key communication skills
A dedication and commitment to furthering the profession into the future
Awards2015The Irish Pharmacy
Community Pharmacy Technician
of the Year 2015
53
DEADLINE FOR ENTRIES: March 27th, 2015Award sponsors have no input to or representation on the independent judging panel; all of whom
have signed a confi dentiality agreement on information pertaining to award entry forms
Further details and application forms can be found by visiting www.pharmacynewsireland.com or for all enquiries related to the
Awards contact Kelly Jo Eastwood on Tel: 01 6690562 Email: [email protected]
David O'Meara, Pharmacy Plus, Birr, 2014 winners of the Johnson & Johnson Community Pharmacy Team of the Year
54
Nutrients to support the ageing body
The role of omega-3 fatty acids and vitamin D in heart health, joint health and skeletal health
Cardiovascular disease – Ireland's leading cause of death
Cardiovascular disease is the leading cause of death in industrialized countries. Coronary artery disease (CAD) is the most common form of cardiovascular disease. The main risk factors are elevated blood serum lipids, which can promote the build-up of fatty deposits in the coronary arteries, and high blood pressure.
Cardiovascular disease kills approximately 10,000 people in Ireland each year.2 The risk of CVD can be reduced by maintaining a healthy level of activity,3 not smoking,4 and eating a healthy, balanced diet.5,6
In Ireland, 71% of men and 54% of women aged 45+ have high blood pressure7
Osteoarthritis – a common disease of ageing
Changes in the joints also occur with advancing age, potentially leading to osteoarthritis. This is a common disorder among older adults, affecting around 400,000 people in Ireland.8
In osteoarthritis, joints become stiff and painful
as cartilage wears away faster than it can be replaced. In the normal situation, cartilage creates a cushioning effect between the bones in our joints. In osteoarthritis, however, loss of this cartilage causes the bones of the joint to rub against one another directly without any cushioning in between. This leads to inflammation which not only causes pain, but also further damages the bones and other tissues in the affected joint. The pain and inflexibility associated with osteoarthritis can significantly affect a person's ability to participate in normal daily activities, having a major impact on their overall quality of life.
Osteoporosis – a silent foe
Osteoporosis, a condition characterised by porous, brittle bones, is often referred to as a “silent” disorder. This is because sufferers often have no prior indication that they have the condition until they sustain a minimal impact or “fragility” fracture of the hip, spine or wrist. Low vitamin D status has long been established as a critical risk factor for osteoporosis,9,10 while evidence is now beginning to emerge of a role for omega-3 fatty acids in protection against osteoporotic bone change.11,12
Helping to protect your customers from within – the role of omega-3 fatty acids for the ageing body
There is evidence that consumption of DHA and EPA omega-3 fatty acids, found predominantly in oily fish, can be of benefit to both cardiovascular13 and joint health14 as the body ages.
Omega-3 and vitamin D in heart health
The role of omega-3 fatty acids in heart health began to be understood in the 1970s, when studies comparing Inuit and Danish populations found far lower rates of heart disease among the Inuit people.15
This disparity in cardiovascular outcomes was attributed to dietary differences between the two populations – while the Danish population consumed a typical "Western" diet, the Inuit diet consisted largely of meat and fish, and was high in omega-3 fats. The higher dietary intake of omega-3 fats observed among the Inuit population yielded significantly greater tissue levels of omega-3, and it was these higher tissue levels which were thought to reduce their overall cardiovascular risk.
Since these early findings, omega-3 fatty acids have been associated with a wide range of cardio-protective benefits. These include reduced serum triglyceride levels,16 reduced blood pressure,17 reductions in platelet activation and clotting,18 reduced inflammation19 and a reduction in vasospasm and arrhythmia.20 Recent research has even suggested that enhanced omega-3 intake might reduce the risk of weight gain and central obesity.21
Optimal vitamin D status has also been associated with reduced risk of cardiovascular disease.22 Several mechanisms have been suggested for this protective effect including reductions in serum lipid levels23 and in blood pressure.24
Overall, the weight of evidence suggests that increased omega-3 PUFA25,26 and vitamin D27 intakes are associated with a reduced risk of cardiac death.
Omega-3 and vitamin D in healthy joints
Omega-3 fatty acids are active against the biological mechanisms of cartilage breakdown.
As people age, their bodies change. The risk of cardiovascular disease, including heart disease and stroke, increases as people get older, and circulatory diseases are the leading cause of death in Ireland1 and around the world.2
Developed by Dr Daniel McCartney B.Sc./Dip. Diet, M.Sc., Ph.D. Lecturer in Human Nutrition and Dietetics at Diet and Health Solutions - Jauary 2015.
55
They ‘switch off’ the enzymes that break down joint cartilage to slow the progress of cartilage degradation, reduce inflammation and lessen pain.28
The omega-3 fatty acids EPA and DHA found in oily fish and fish liver oil supplements enable the formation of less-inflammatory prostaglandins and leukotrienes, thereby reducing overall inflammation.29,30 Omega-3 fatty acids have also been shown to reduce the need for NSAID use in patients with osteoarthritis.31
In addition to the anti-inflammatory benefits of omega-3 fatty acids against osteoarthritis, there is now also emerging evidence of a possible association between low vitamin D levels and risk and progression of osteoarthritis.32,33 One recent pilot randomised controlled trial has also shown improvements in knee pain and function over 12 months in patients given high dose vitamin D supplements.34
Omega-3 and vitamin D in osteoporosis
Vitamin D deficiency has been linked with lower bone mineral density and increased markers of bone turnover,35 as well as increased fracture risk.36 Those who increase their serum vitamin D levels on the other hand, have a much lower risk of fracture.37 Crucially, optimising vitamin D status has also been shown to reduce the risk of falls in older adults,38 indicating that its protective effect against fracture extends beyond its positive impact on bone mineral density.
Suggestive evidence for a protective effect of omega-3 fatty acids against osteoporosis is now also coming to the fore,39 with studies linking this effect to omega-3’s roles in both inflammation40 and enhancements in osteoblastic and osteoclastic cell populations.40,41
Sources of omega-3 and vitamin D
Oily fish like mackerel, herring and sardines are a good dietary source of long chain omega-3s and vitamin D. The Food Safety Authority of Ireland (FSAI) recommends that people eat 2 portions of fish every week, one of which should be oily.42
Evidence suggests that intakes of critical nutrients are sub-optimal in the Irish population. It’s been estimated that Irish adults consume an average of just 275 mg/day of EPA and DHA omega-3 fish oils43, considerably less than the recommended 500 mg/day. Additionally, recent research suggests that more than three-quarters of Irish adults have low serum vitamin D levels on a year-round basis,44 and that this deficit in vitamin D status is a major contributor to inflammation in older Irish adults,45 while 15-20% of Irish adults don’t get enough vitamin A in their diet.46
Whatever the reasons – dislike of the taste or texture, fears about bones, or simply lack of awareness of its health benefits – oily fish consumption is clearly far lower than it should be in the Irish population. For those who are unwilling to eat oily fish, fish liver oils offer an alternative way of obtaining sufficient DHA, EPA and vitamin D; thus providing the cardiovascular, joint and skeletal health
benefits associated with adequate intake of these nutrients. Additionally, these fish liver oils are a rich source of vitamin A, a nutrient also often consumed in low amounts by the Irish population.
Cod liver oil has been used as a traditional dietary supplement for generations. We now know that fish liver oils are rich in omega-3 fatty acids and vitamin D which have been associated with multiple cardiovascular health benefits as well as symptomatic relief of osteoarthritis and delayed cognitive decline in older adults.
Additional nutrients that may help protect your customers as they grow older
Omega-3 and vitamin D intakes are critically important as people get older, but it isn't the end of the story. The following vitamins and nutrients may also be of benefit to those who wish to maintain good health as they get older:
Glucosamine sulphate - Shown to reduce pain and improve function, and to possibly reduce knee-joint space narrowing47
Chondroitin sulphate - Shown to relieve pain and joint swelling in arthritis47,48
Top tips for customers1. To help prevent cardiovascular
disease, aim to maintain an active lifestyle, eat a balanced diet and avoid smoking.
2. Aim to eat 2 portions of fish per week, one of which should be oily to benefit from the positive health effects of omega-3 and vitamin D.
3. Alternatively, if you don’t like fish, consider taking fish oil supplements which can also help to provide omega-3s and vitamin D for cardiovascular, skeletal and general health.
4. For balanced nutrition ensure you consume a varied diet which includes leafy green vegetables, fruit, vegetables and wholegrain cereals.
Sponsored by Merck Consumer Healthcare
References1. Kabir Z et al. Int J Cardiol 2013; 168 (3): 2462-7.2. Facts on Heart Disease and Stroke. Irish Heart Foundation website.
Available at http://www.irishheart.ie/iopen24/facts-heart-disease-stroke-t-7_18.html. Last accessed 8/10/14.
3. Held C et al. Eur Heart J 2012; 33 (4): 452-66. doi: 10.1093/eurheartj/ehr432. Epub 2012 Jan 11.
4. Teo KK et al. Lancet 2006; 368 (9536): 647-58.5. Iqbal R et al. Circulation 2008 Nov 4;118(19):1929-37. doi: 0.1161/
CIRCULATIONAHA.107.738716. Epub 2008 Oct 20.6. Dehghan M et al. Circulation 2012; 126 (23): 2705-12.7. Barron S et al. BMC Public Health 2014; 14:24. doi: 10.1186/1471-
2458-14-24.8. MyKnee.ie website http://myknee.ie/osteoarthritis. Accessed 8/10/14.9. Chapuy MC et al. N Engl J Med 1992; 327 (23): 1637-42.10. Li S et al. Ann Nutr Metab 2014; 64 (1): 13-9. doi:
10.1159/000358340. Epub 2014 Mar 13.11. Kelly OJ et al. Nutr Res 2013; 33 (7): 521-33. doi: 10.1016/j.
nutres.2013.04.012. Epub 2013 Jun 10.12. Farina EK et al. Am J Clin Nutr 2011; 93 (5): 1142-51. doi: 10.3945/
ajcn.110.005926. Epub 2011 Mar 2.13. Harris WS et al. Curr Atheroscler Rep. 2008; 10 (6): 503-9.14. Miles EA, Calder PC. Br J Nutr 2012; 107 Suppl 2: S171-84. doi:
10.1017/S0007114512001560.15. Bang HO & Dyerberg J. The Lancet 1971; June 5: 1143-1146.16. Kastelein JJ et al. J Clin Lipidol 2014; 8 (1): 96-106.17. Campbell F et al. Eur J Prev Cardiol 2013; 20: 107-120.18. Larson MK et al. Am J Physiol Cell Physiol 2013; 304 (3):
6. doi: 10.1016/j.bbalip. 2014.08.101 [Epub ahead of print].20. Kar S. Rev Cardiovasc Med 2013; 14 (2-4): e82-91.21. Bender N et al. Obes Rev. 2014; 15 (8): 657-65. doi: 10.1111/
obr.12189. Epub 2014 May 29.22. Wang L et al. Circ Cardiovasc Qual Outcomes 2012; 5 (6): 819-29.
doi: 10.1161/CIRCOUTCOMES.112.967604. Epub 2012 Nov 13.23. Carbone LD et al. Metabolism 2008; 57 (6): 741-8. doi: 10.1016/j.
metabol.2008.01.011.24. Larsen T et al. Am J Hypertens 2012; 25: 1215-22. doi: 10.1038/
ajh.2012.111.25. Jump DB et al. J Lipid Res 2012; 53: 2525-2545.26. Chowdhury et al. Ann Intern Med 2014; 160 (6): 298-406.27. Kendrick J et al. Atherosclerosis 2009; 205 (1): 255-60. doi:
10.1016/j.atherosclerosis.2008.10.033. Epub 2008 Nov 11.28. Wann AK et al. Arthritis Res Ther 2010; 12 (6): R207. doi: 10.1186/
10.1017/S0007114512001638.40. Maggio M et al. Curr Pharm Des 2009; 15 (36): 4157-64.41. Casado-Díaz A et al. Osteoporos Int 2013; 24 (5): 1647-61. doi:
10.1007/s00198-012-2138-z. Epub 2012 Oct 27.42. Food Safety Authority of Ireland (2011). Scientific recommendations
for Healthy Eating Guidelines in Ireland. Dublin: FSAI.43. Leite JC et al. Int J Food Sci Nutr 2010; 61 (6): 583-99. doi:
10.3109/09637481003652442.44. Cashman KD et al. Br J Nutr 2013; 109: 1248-56.45. Laird E et al. J Clin Endocrinol Metab 2014; 99 (5): 1807-15. doi:
10.1210/jc.2013-3507. Epub 2014 Feb 25.46. Walton J (2011) National Adult Nutrition Survey – Summary
Report on Food and Nutrient Intakes, Physical Measurements, Physical Activity Patterns and Food Choice Motives. Dublin: Irish Universities Nutrition Alliance.
47. Kantor ED et al. J Attern Complement Med 2014; 20 (6): 479-85. doi: 10.1089/acm.2013.0323. Epub Apr 16.
48. Henrotin Y et al. Maturitas 2014; 78: 184-187.
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Out & AboutIACPT Conference 2014The annual Irish Association of Community Pharmacy Technicians (IACPT) Conference 2014 took place in Carlow IT recently and there was a great turn out for the event.
Health and information talks were given throughout the day, and pharmaceutical companies and locum companies such as Actavis, Pharmaconex, CPL Healthcare, Bayer, Clarity Locums, and Clonmel Healthcare exhibited stands with information and up to date knowledge for Pharmacy Technicians.
An AGM was also held at the Conference to discuss arising issues for Pharmacy Technicians and the IACPT also appointed some members to new positions. Clare Ward was re-appointed as President of the IACPT and Marie-Louise Phillips was appointed as the incoming Vice President. Marie-Louise Phillips Vice President of IACPT, Clare Ward
President of IACPTGrainne O'Connor and Maria Purcell from Bayer
Anthony O'Reilly from Clarity Locums Michelle Duff from ActavisJo O'Connell from CPL Healthcare
Elaine Lorigan- McSweeney, Clare Ward, Marie Louise Phillips, Noelle Lison, Majella Torsney from IACPT
Garry O'Riordan, Stuart Brown, Paolo Iacovelli from Pharmaconex
Alison Feeley from National Camcer Screening Service
Noelle Liston, Karen Martin, Majella Torsney from IACPT Stephen Tighe from Clonmel HealthcareIT Carlow Students
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Out & AboutSchool of Pharmacy Prize-GivingThe School of Pharmacy and Pharmaceutical Sciences at Trinity College Dublin recently hosted its annual prize-giving ceremony. The event was held in the Global Room. Professor Anne Marie Healy, Head of the School of Pharmacy & Pharmaceutical Sciences welcomed academics, sponsors, students, family and friends to the ceremony.
The Prize Giving Ceremony is a celebration of the outstanding performance of the TCD Pharmacy students in their academic achievements in the B.Sc. (Pharm.) Degree course. Prizes are awarded for high academic performance in particular areas of Pharmacy study. The School views each award as a statement of support and recognition for their students.
Pharmacy Alumni Prize - Winner, Eibhlin Fitzpatrick: This prize is awarded for the best combined overall mark in the Junior Sophister year and was presented by Dr Catriona Bradley, Executive Director of the Irish Institute of Pharmacy. Pictured is Professor Anne Marie Healy, Ms Eibhlin Fitzpatrick and Dr Catriona Bradley.
Pfi zer Healthcare Ltd Junior Freshman Pharmacy Prize - Winner, Aife Kavanagh and Matthew Comer: This is awarded for overall fi rst place in the Junior Freshman Pharmacy Annual Examination and was presented by Asstistant Professor Astrid Sasse, Director of Teaching and Learning (Undergraduate) and Mr John Molony, Pfi zer.
Paul Higgins Memorial Prize - Prize in Pharmaceutical Chemistry - Winner,Caroline Walsh: This is awarded to the student who attains the highest overall combined mark in modules PH3002 and PH4002.It was presented by Professor Mary Meegan and Mr Brian Collins, Uniphar Group.
McNeil Pharmaceutical Prize - Winner,Ailbhe Manning: This prize is awarded to the student who attains the highest overall combined mark in modules PH4006 and PH4007 (including electives).It was presented by Associate Professor Martin Henman and Mr Brendan McLouglin, McNeil Healthcare (Ireland) Ltd.
Sanofi Ireland Prize - Winner, Caroline Walsh: The Sanofi Ireland Prize is awarded to the student who attains the highest overall combined mark in modules PH3003 and PH4003 and was presented by Associate Professor John Walsh and Dr Liz Bergin, Sanofi Ireland.
Pfi zer Healthcare Ltd Prize in Pharmacology - Winner, Caroline Walsh: The Pfi zer Healthcare Ltd Prize in Pharmacology is awarded to the student who attains the highest overall combined mark in modules PH3009, PH3010, PH3011, PH4009 and PH401. It was presented by Assistant Professor Carlos Medina Martin and Mr John Molony, Pfi zer Healthcare Ltd.
The Actavis Academy Senior Sophister Pharmacy Prize - Winner, Caroline Walsh:The Actavis Academy Senior Sophister Pharmacy Prize was warded to the student who attains the highest overall mark in the Pharmacy degree. It was presented by Professor Anne Marie Healy, Head of School and Ms Louise Mooney, Actavis.
Eibhlin Fitzpatrick and Dr Catriona Bradley from IIOP
Aoife Kavanagh, Matthew Comer, John Molony from Pfi zer Healthcare Ireland, Asst. Prof. Astrid Sasse
Caroline Walsh, Rachel Gaul, Eibhlin Fitzpatrick, Aoife Kavanagh, Matthew Comer, Ailbhe Manning with Prof Anne Marie Healy
Caroline Walsh, Dr Liz Bergin, Assoc. Prof. John Walsh
Caroline Walsh, Louise Mooney from Actavis, Professor Anne Marie Healy
Caroline Walsh, John Molony from Pfi zer Healthcare Ireland, Asst. Prof. Carlos Medina
Rachel Gaul, Dr Lorraine Nolan Ailbhe Manning, Mr Brendan McLoughlin from McNeil Healthcare, Assoc. Prof. Martin Henman
Caroline Walsh, Brian Collins from Uniphar, Professor Mary Meegan
* Results from 6 month user group with 52 females conducted by Medical Dermatologist Dr. Leila Bloch, Clinical Bloch, Sao Paulo, Brazil. † Hair Growth Catorgory 52 weeks IRI Data USA wk ending 2/11/2014
Why Viviscal?• Over 4 million boxes sold worldwide
• 1 box sold every minute in 2014
• 9 clinical trials support efficacy
• 91% of women noticed thicker hair*
• We are an Irish company, based in Galway
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Why Viviscal?• Over
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60
Clinical Profiles
NOXAFIL® (posaconazole) 300mg Concentrate for Solution for Intravenous Infusion Launched in the UKNew Formulation offers another treatment option of NOXAFIL for critically ill patients who are unable to take oral formulations
Launch of Noxafil by MSD
MSD (Merck Sharp & Dohme Limited) have announced the UK launch of NOXAFIL® (posaconazole), 300mg concentrate for solution for intravenous infusion (iv), which offers another option to treat fungal infections in critically ill patients who are unable to take oral versions. This follows the European Commission approval granted on 18th September 2014.
Posaconazole now offers the benefit of being available in a range of formulations, to suit the needs of various clinical situations and different types of patients. Following the completion of the i.v. clinical development programme, where the pharmacokinetic and safety data was bridged to the existing data (including efficacy data) from the oral suspension studies, posaconazole is now available as concentrate for solution for infusion with a once-daily dosing regimen after a twice-daily loading dose on day one.
The burden of invasive fungal disease (IFD) continues to increase as a result of improved medical intervention and supportive care. The growing number of patients with a variety of risk factors such as transplantation, chemotherapy, HIV infection, use of corticosteroids or new immunosuppressive agents, have caused an increase in incidence of invasive infections in recent years. Fungal infections are a significant source of morbidity especially in immunocompromised patients, with attributable mortality from invasive fungal infections (IFIs) ranging from 60-90% for invasive aspergillosis and exceeding 80% for invasive zygomycosis and fusariosis.
Invokana now available to Irish patientsJanssen have announced that INVOKANA® (canagliflozin), a treatment for adults with type 2 diabetes mellitus, will be available to Irish patients from 1st December 2014. Canagliflozin is an oral, once-daily medication, which belongs to a new class of medications called sodium glucose co-transporter 2 inhibitors.
Invokana is indicated for reducing blood glucose levels in people for whom diet and lifestyle measures or treatment with other blood glucose-lowering medicines, do not provide adequate control. Invokana
For more information on Actavis and the Products available please see www.actavis.ie or contact the office in Cork on 021 -461 9040
Boehringer Ingelheim receives EU CHMP positive opinion for nintedanibThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently issued Boehringer Ingelheim a positive opinion for nintedanib, in combination with docetaxel, for the treatment of patients with advanced non-small cell lung cancer (NSCLC) of adenocarcinoma histology after first line chemotherapy.
The CHMP’s positive opinion is now referred to the European Commission (EC), which grants marketing authorisation for medicines in the European Union. If approved, nintedanib will be the first triple angiokinase inhibitor licensed for the treatment of second-line adenocarcinoma of the lung. Nintedanib is an investigational agent and not currently licensed in the Republic of Ireland.
The CHMP positive opinion is based on the international, randomised, double-blind, placebo-controlled, Phase III LUME-Lung 1 trial which compared nintedanib plus docetaxel to placebo plus docetaxel in patients with locally advanced/metastatic or recurrent NSCLC after failure of first-line therapy. In the trial, the median overall survival broke the one year barrier in patients of adenocarcinoma histology treated with nintedanib plus docetaxel (12.6 months for nintedanib plus docetaxel vs. 10.3 months for placebo plus docetaxel; p=0.0359). The data also demonstrated that adenocarcinoma patients who progressed within nine months of the start of first-line chemotherapy achieved a median overall survival benefit of three months (10.9 vs 7.9 months respectively; p=0.0073) with the addition of nintedanib to docetaxel.
There was no impact on overall global health or quality of life with the addition of nintedanib to docetaxel in patients of adenocarcinoma histology. The most common adverse events (AEs) in the nintedanib plus docetaxel arm, compared to docetaxel alone, were gastrointestinal side effects and reversible liver enzyme elevations which were manageable with supportive treatment or dose reduction (adverse events nintedanib vs. placebo: diarrhoea 43.4% vs. 24.6%, ALT elevation 37.8% vs. 9.3%, AST elevation.
also provides the additional benefits of weight loss and blood pressure reduction. However, it is not indicated for weight reduction or blood pressure reduction.
The kidneys make an important contribution to balance blood glucose. As glucose is filtered from the blood into the kidneys it is reabsorbed back into the bloodstream. An important carrier responsible for this reabsorption is called sodium glucose co-transporter 2 (SGLT2). Canagliflozin selectively inhibits SGLT2, and, as a result, promotes the loss of glucose via the urine, lowering blood glucose levels in adults with type 2 diabetes. Canagliflozin will be available across the spectrum of adult type 2 diabetes management, in patients who need further glucose control as a single agent (monotherapy), in combination with metformin, and in combination with other glucose-lowering agents, including insulin.
Dr Leisha Daly, Country Director, Janssen Ireland, welcomed the announcement. “The launch of INVOKANA® in Ireland is a great step forward in Janssen’s ongoing journey and commitment to diabetes care. We hope that it will also mark the start of a new journey for type 2 diabetes patients and their clinicians who now have new therapeutic options available to them.”
It is estimated that there are over 225,000 people in Ireland with diabetes and 90% of those, or 205,000, live with type 2 diabetes. This number is expected to rise to over 250,000 by 2030. A recent TILDA study estimated that there are over 15,600 people over 80 years of age living with type 2 diabetes and a prevalence of 11.9% in the over 75 age group. Despite there being a number of treatments currently available, many patients are still unable to achieve and maintain long-term control of their blood sugar. Type 2 diabetes is a progressive disease that can to be managed by a combination of diet, exercise and medication. If left uncontrolled the condition can lead to debilitating complications.
The efficacy of INVOKANA® was supported by a comprehensive global Phase III clinical programme, which enrolled more than 10,300 patients in nine studies, and is one of the largest late-stage development programmes for an investigational pharmacological product for the treatment of type 2 diabetes submitted to health authorities to date. It assessed the efficacy and tolerability of canagliflozin across the spectrum of adult type 2 diabetes management, in patients who needed further glucose control as a single agent (monotherapy), in
combination with metformin, and in combination with other glucose-lowering agents, including insulin.
Actavis adds Cystic Fibrosis range to its PortfolioOn the 1st July 2014, Actavis, a leading global speciality pharmaceutical company, completed the acquisition of Forest Laboratories, Inc.
Following this important acquisition, Actavis Ireland will take over the distribution of the following Cystic Fibrosis products from the 1st January 2015:
Product Name Colobreathe 1662500IU INH PDR x 56 Hard Caps
Pack Size 56 Caps
Trade Price ¤1416.00
Generic Name Colistimethate Sodium 125mg
Product Name Colomycin 1M IU PDR FOR SOLN/INJ/INF
Pack Size 10 Vials
Trade Price ¤25.04
Generic Name Colistimethate Sodium 1million
Product Name Nebusal 7% Hypertonic Saline 4ML
Pack Size 60 UDV
Trade Price ¤40.00
Generic Name Hypertonic Sodium Chloride Solution
Products will continue to be available to order through the wholesale network.
Speaking about this exciting addition to the Actavis Product Portfolio, Caroline Fitzgerald, Hospital Business Manager said, “The new Actavis has strong portfolios in infectious diseases including Cystic Fibrosis; and has committed to invest approximately $1 billion annually in R&D to develop new products that meet the healthcare needs of patients in Ireland and around the world.
“The combination of Actavis and Forest creates a new breed of specialty pharmaceutical company, with a balanced offering of strong brands and generics. The inclusion of this Cystic Fibrosis range to the Actavis portfolio is the latest example of Actavis’s commitment to speciality brands in niche therapeutic areas. We plan to expand the Cystic Fibrosis product range in Ireland in the coming weeks and months ahead.”
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Unique sterilised, hygienic cloth wipes for safe,effective and gentle cleansing of the eyelids and lashes.
TLC Eye Care Wipes are preservative free, hypoallergenic,dermatologically and opthalmalogically tested.
Available in two variants: For Adults and a uniqueextra mild formula for babies.
Eye Care Wipes
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Clinical Profiles
Daiichi Sankyo Launches New Formulation of LIXIANA® 60 mg Tablets
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) has announced that it has launched a new formulation of LIXIANA® 60 mg Tablets in Japan for the recently approved indications: the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and the treatment and recurrence prevention of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmo-nary thromboembolism (PE)]. LIXIANA was approved in Japan in April 2011, for the prevention of VTE after major orthopedic surgery and was launched in July 2011.
LIXIANA was also approved in Japan in September 2014 for the prevention of ischemic stroke and systemic embolism in patients with NVAF and for the treatment and recurrence prevention of VTE. Daiichi Sankyo has also filed for approval of once-daily edoxaban in both the U.S. and EU for the reduction in risk of stroke in NVAF and for symptomatic VTE in patients with DVT and/or PE.
VTE is an umbrella term for two conditions, DVT and PE. DVT is a blood clot found anywhere in the deep veins of the legs, while PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition. VTE is a major cause of morbidity and mortality world-wide with an annual incidence estimated at one per 1,000 (with some age and regional variation).
Edoxaban is an investigational, oral, once-daily anticoagulant that specifically inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting. The global edox-aban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation), which included nearly 30,000 patients combined. The results from these trials form the basis of regulatory filings for edoxaban for symptomatic VTE in patients with DVT and/or PE, and for the prevention of stroke in NVAF, respectively.
Dermal Laboratories launch EmolliZoo Dermal Laboratories has launched a new educational, non-promotional mobile app called EmolliZoo which is designed to help children with eczema and their families have a better understanding of eczema, their skin and the emollients used to manage the condition.
The EmolliZoo app will allow children with eczema and their families to;
• Learn about eczema with the friendly Zookeeper and find out how she helps her animals with dry skin. All EmolliZoo educational material is accredited by the National Eczema Society.
• Set up a personalised treatment calendar which can be customised to reflect ANY emollient routine and deliver gentle therapy reminders to encourage dry skin treatment.
• Learn the correct ways to use their own emollient by helping the Zookeeper put emollients on her animals through gameplay.
• Be rewarded with stickers and certificates for applying their emollient which helps to reinforce good emollient use.
EmolliZoo contains a separate parent’s section which includes more detailed information about the skin, eczema and emollients and other useful features such as emollient-use trackers and the ability to attach notes and photos to calendar entries for discussion with healthcare professionals.
EmolliZoo is free to download from the app store as an iPhone app, which is also available on iPad and iPod Touch. To download the app, visit www.emollizoo.co.uk via your iPhone, iPad or iPod Touch and click the ‘Available on the App Store’ logo. Alternatively, to find the app in the App Store, simply type “EmolliZoo” into the search bar (select the option ‘iPhone only’ if using an iPad).
An android version of EmolliZoo will be available later in 2015.
For further information about EmolliZoo please visit www.emollizoo.co.uk or contact Dermal directly at [email protected]
The National Eczema Society does not recommend or endorse any specific products or treatments.
Malaria vaccines undergo clinical trials
Two new malaria vaccines which have undergone a clinical trial in humans, carried out by researchers at RCSI (Royal College of Surgeons in Ireland) in Dublin, have been proven to be well tolerated and produce a strong immune response. The results of the clinical trial are published in the current issue of the journal PLOS ONE. The clinical trial was conducted by researchers at RCSI’s Department of International Health & Tropical Medicine at the RCSI Clinical Research Centre in Beaumont Hospital, Dublin, in collaboration with the Jenner Institute at the University of Oxford. The project is funded by the European Vaccine Initiative (EVI) with the support of Irish Aid.
This is the first time the new vaccines were trialled in humans and the first human clinical trial of any malaria vaccine to be carried out in Ireland. Completion of this type of “first in human” study (phase one) in Ireland is significant not only for malaria vaccine research, but also for translational research in general in Ireland.
The clinical trial involved 24 Irish volunteers who received the vaccines to assess safety and the immune responses. The vaccines were found to have an excellent safety profile and produced the appropriate immune response, generating specific T cells that are primed to respond to malaria proteins. Combining these vaccines with others in development may lead to a vaccine that could prevent malaria, which would have a huge impact on human health as a result. The vaccines have now progressed to the next phase of clinical trials at the University of Oxford.
The first author on the study is Dr Eoghan De Barra, Research Fellow, RCSI Department of International Health & Tropical Medicine, who worked with collaborators at RCSI and senior author Professor Adrian Hill, Director of the Jenner Institute at University of Oxford.
The two new malaria vaccines (ChAd63 CS and MVA CS) were developed at University of Oxford and use the gene for malarial circumsporozoite protein inserted into a weakened adenovirus.
EVI is a leading European non-profit Product Development Partnership that has the principal objective to develop effective, accessible, and affordable vaccines against malaria and other diseases of poverty. Since its inception in 1998 it has contributed to the development of 32 malaria vaccine candidate formulations with 16 vaccine candidates being advanced into phase I clinical trials, three of which have been transitioned for further clinical development in sub-Saharan Africa. EVI leads global efforts in the development of vaccines against diseases of poverty, while also acting as coordinator of several initiatives/consortia to create harmonisation between all global stakeholders in vaccine research. EV is co-founder of the Malaria Vaccine Funders Group and is hosted by Heidelberg University in Germany. EVI is currently funded by Irish Aid, the European Commission, EDCTP, and the German Federal Ministry of Education and Research (BMBF).
Safety information for Tecfidera
In agreement with the European Medicines Agency (EMA), Biogen Idec would like to inform healthcare professionals of important safety information regarding a case of PML related to use of Tecfidera in the treatment of multiple sclerosis:
In October 2014, a fatal case of PML, in the setting of severe prolonged lymphopenia, was reported in a patient receiving Tecfidera for 4.5 years. This is the first case of PML associated with Tecfidera. Patients should be informed that there is a risk of this serious condition.
Lymphopenia is a known adverse drug reaction of Tecfidera and patients under treatment should be monitored regularly. Complete blood counts (CBC), including lymphocytes, should be checked regularly and at close intervals as clinically indicated.
Patients receiving Tecfidera who experience lymphopenia should be monitored closely and frequently for signs and symptoms of neurological dysfunction
When PML is suspected Tecfidera should be discontinued immediately.
Date of Preparation, Jan 2015. KR --001-15. Approved indication for Pregabalin KRKA: General Anxiety Disorder and Epilepsy in Adults. When compared with the original brand, Pregabalin KRKA does not have the indication for the treatment of Neuropathic Pain. PA1347/050/001-8. Krka Pharma Dublin Ltd, Suite 6 The Mall, Beacon Court, Sandyford, Dublin 18, Ireland, Tel + 353 1 2939180, Fax + 353 1 2939185, [email protected], www.krka.ie
