MEDICINES
matter
October 2008
Helping older people know more about their medicines The Irish Pharmaceutical Healthcare Association (IPHA) and the Irish Pharmacy Union (IPU) in association with Age Action Ireland launched a campaign this month to help older people know more about their medicines. Understanding how medicines work and taking medicines properly can have a dramatic effect on older people’s lives and well-being, helping them stay healthy and live independently in the community for longer. If older people are not taking their medicines properly, they are less likely to recover from illness and more likely to end up in hospital. If this is happening over a prolonged period and the patient’s health and quality of life deteriorates, they are no longer able to live independently in the community and often need to move into hospital or nursing home care with increased direct and indirect costs to the State.
We know that the use of medicines increases with age. In fact 47% of all prescribed medicines are taken by older people. We also know that older people are two to three times more at risk, than younger adults, of having an adverse reaction to a medicine. The ‘Master Your Medicines’ campaign seeks to lower that risk by encouraging older people to speak to their pharmacist, learning about their medicines and raising any concerns that they may have with them. By doing this older people will be in a better position to get the maximum benefit from their medicines.
The campaign elements include: -
An information booklet which is available from pharmacies nationwide. It provides information on all aspects of taking medicines including information on medicines and falls, information for carers and a Patient Medication Record;
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A Medicines Reminder Chart which is available for download from www.ipha.ie; and
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A national radio infomercial encouraging older people to speak to their pharmacist about their medicines.
Members of the Lucan Retirement Group with their local pharmacist at the launch of the Master Your Medicines campaign.
IN THIS ISSUE
New IPHA President Counterfeit medicines
Ireland needs a clinical research “supremo” IPHA Charity Golf
and more...
New IPHA President Dr Gerald Farrell has been appointed President of the Irish Pharmaceutical Healthcare Association (IPHA). Gerald is currently Managing Director for Eli Lilly in the Republic of Ireland, having joined the company, a leading innovationdriven pharmaceutical corporation in 1989. He has held various positions including assignments in new product planning, market research, sales management and manufacturing both in the UK and Ireland. Prior to his current position he was Director of Strategy, Commercial & Business Information from 1999 to 2003 in the UK. Upon taking office Gerald said that “The pharmaceutical industry’s commitment to
meeting the needs of patients is unequivocal. It is our responsibility to meet their needs and provide them with new and better medicines to treat disease. As we face into a challenging period IPHA will continue to build on the successful partnerships developed between the industry, the State and its various agencies in order to ensure that patients continue to have access to these new and better medicines.” Gerald has a PhD in Biotechnology from University College Cork and a BSc in Plant Science from University College Galway (National University of Ireland, Galway). He will hold the position of IPHA President for a term of two years.
Doctor Gerald Farrell
IPHA and IMB collaborate to improve reporting of suspected adverse reactions IPHA has enhanced www.medicines.ie and the Medicines Compendium 2008/2009 CD-ROM by including a specific page on Adverse Reaction Reporting which links directly to the Irish Medicines Board (IMB) website. This is part of an initiative, in collaboration with the IMB, to increase health professional reporting of suspected adverse reactions. Commenting on the collaboration, IPHA’s Scientific & Regulatory Affairs Manager Rebecca Cramp PhD stated that: “The reporting by healthcare professionals, of suspected adverse reactions that occur after a product is licensed, is very important to facilitate the assessment of the evolving benefit/risk profile of a medicine over its lifetime and we hope that the link from www.medicines.ie to the IMB’s website will enhance that process.” The Medicines Compendium 2008/2009 CD-ROM is a copy of the successful IPHA medicines.ie website which provides up to the minute information on prescription and ‘overthe-counter’ (non prescription) medicines. The CD-ROM is primarily designed for those who do not have ready internet access in their practice.
The CD-ROM is sent annually, free of charge, to 6,500 GPs, Consultants and community and hospital pharmacists in the country. The CD-ROM provides independent, IMB/EMEA approved information on over 2,000 medicines currently available in Ireland. It allows the user to access information about the medicines available in Ireland – such as what they are indicated to treat, possible adverse reactions and how one medicine might interact with another.
If you would like to order a copy of the Medicines Compendium 2008/2009 please contact compendium@ipha.ie.
Ireland needs a clinical research “supremo” More than 200 delegates from patients’ organisations, industry, science and public policy met recently in Dublin Castle to discuss how Ireland may become globally competitive in clinical research. The meeting was organised by the Irish Platform for Patients’ Organisations, Science and Industry (IPPOSI) in association with IPHA. Delegates were addressed by Minister for Health and Children, Mary Harney, TD, who stressed the value of collaboration: “In a country as small as this I’m interested in people working together.” Everybody has a common goal, she said – to improve healthcare and improve access to new medicines, and that, she said, makes research “very much a front-line activity”. IPPOSI Chair Michael Griffith stressed that Irish patients want a world-class clinical research infrastructure in Ireland – and he reminded the audience that we are all, or at some time will be, patients. Yet in Ireland the lack of that infrastructure contrasts sharply with Ireland’s position as one of the world’s most attractive locations for pharmaceutical manufacturing. Worse, as Anne Nolan, CEO of IPHA, said, Ireland is losing its attractiveness for clinical research. The result, she said, is that “Irish subsidiaries find it increasingly difficult to compete internally, to convince corporate headquarters to conduct clinical research in Ireland.” Other industry speakers mooted similar concerns. For Dr. John Stinson, Medical Director of LEO Pharma, Ireland had many strengths, with big changes in the past 12
years. He pointed to high standards among clinicians and scientists, altruistic patients and population, a desire to think creatively and, from pharma, a great hunger for trials and funding. But, he said, there were many weaknesses on indemnity, Ethics Committees, different requirements for submissions, the freeze on recruiting clinical staff; and in relation to the lack of career structures and training, especially in Good Clinical Practice. “We all say the right things,” said Stinson, “but do we really walk the walk?” “There are opportunities”, said Stinson, “with more consultants and much better hospitals than 20 years ago, more funding for science and an entrepreneurial population”. The challenge is to move up the value chain, more towards Phase II rather than Phase III trials. And there are threats: new countries joining the EU, Ireland’s small population, the lack of protected time for research and the shortage of clinical research positions. For patients, that could add up to fewer opportunities to take part in clinical trials and less access to the newest medicines, especially for rarer diseases. Dr. John Farrell, Medical Director of Pfizer, said we need to be clear about what we can deliver and what we cannot. “We need to be able to persuade Pfizer New York that Ireland is a good place to invest money in…If Pfizer does trials in the UK and they fail, they will still do more. If we fail in Ireland it will be much more difficult next time around,” he said. That means looking at infrastructure – especially people, “and especially research nurses”. It is still, said Farrell, “extremely difficult” to get good people to work in research and industry. But it has to be done: “Clinical research shouldn’t be seen as something nice to have but something that Ireland should be involved in.” The good news, from the conference, is that all the building blocks of a good infrastructure seem to be in place, with huge investment in recent years. Building blocks are not enough however: Ireland also needs to provide strong leadership for a clear national strategy that can remove the barriers and, take advantage of the real opportunities that exist. Consensus – on where the problems lie and what the solutions might be – was
Anne Nolan, IPHA Chief Executive speaking at the Clinical Research Conference.
Minister for Health and Children, Mary Harney TD addressing delegates at the Clinical Research Conference.
not hard to find. On the contrary, the remarkable thing about the day’s discussion was the extent of agreement. Equally remarkable - the proposed solutions are not only straightforward, they are not inherently expensive.
Recommendations Five clear individual recommendations emerged from the discussions: 1. Standardise Ireland’s system of Ethical Review Committees, and remove their unpredictability. 2. Create formal career structures for health professionals interested in research, especially (but not only) for research nurses. 3. Integrate internationally accredited training in Good Clinical Practice into medical and nursing education at all levels. 4. Introduce practical and standard indemnity arrangements for clinical trials, in particular for noncommercial clinical research. 5. Make research a core value in healthcare. …and one overarching recommendation 6. Appoint a clinical research “supremo” in the Department of Health and Children with the power to remove the roadblocks and create and deliver a research strategy for health in Ireland.
Counterfeit medicines pose a growing threat to European patient’s health Recently released EU statistics show that over four million medicinal products were seized at EU customs borders in 2007. This was an increase of 51% on the 2006 figure. While Internet-based sales are the main source of counterfeit medicines, these products are being encountered at all stages of the supply network: manufacture, distribution and entry through wholesalers, pharmacists and the black market. Mr Brian Murphy, IPHA Director of Commercial Affairs said the figures show that international traders are continuing to take advantage of more open borders and new technologies such as the Internet to conduct their criminal business without any scruple for people's health. Though traditionally rare in Europe, this growing threat needs to be tackled, in particular, by making the entire European pharmaceutical supply chain as tight and secure as possible. Counterfeit medicines are any medicines and active pharmaceutical ingredients (APIs) that are deliberately and fraudulently mislabelled by unauthorised parties with respect to source, and / or composition and / or therapeutic quality. They have been found to contain toxic substances, no active ingredient, or the wrong amount of it. Life-saving medicines are increasingly targeted, including medicines to treat cancer and heart disease, psychiatric disorders, and infections. “Counterfeiting is attractive because it is a lucrative activity with little risk of being caught. Globalisation has lead to relaxed barriers to trade facilitating the circulation of counterfeit products and a plethora of
actors are now operating internationally or through the Internet and therefore outside the jurisdiction of national regulators” added Mr Murphy The lack of integrity in the supply chain is seen as a facilitating factor. There is no accurate data on the scale of counterfeits in the pharmaceutical sector because they are mainly sold and used in unofficial and uncontrolled settings, thus making them difficult to detect. Or where controls and regulations do exist, reporting is sporadic and not centralised. Strong EU measures to tackle this growing threat, including a ban on medicine repackaging, a harmonised EUsystem of identification of medicines, and heavier penalties for trafficking in counterfeit medicines are required immediately. The World Health Organisation (WHO) estimates that 8% to 10% of the medicines in the global medicine supply chain are counterfeit, reaching as high as 25% in some countries. The largest counterfeit market with close proximity to the EU is Russia, where it is estimated that 12% of medicines are counterfeit. An increasing conduit being used by counterfeiters is the Internet. An in-depth
report by the European Alliance for Access to Safe Medicines (EAASM) entitled the Counterfeiting Superhighway , examining internet pharmacies and lifesaving medicines purchased online, revealed that a frightening 62% of medicines purchased online are fake or substandard. These include medicines indicated to treat serious conditions such as cardiovascular and respiratory disease, neurological disorders, and mental health conditions. Mr Murphy said in response to the EAASM report that “Patients must be encouraged to purchase prescription medicines through authorised distribution channels only. Only then can patients be guaranteed to be getting a genuine pharmaceutical product.” Proposals for tougher EU legislation are expected before the end of 2008, as part of a new ‘pharmaceutical package’ being developed by the European Commission. Options outlined by the Commission in its public consultation document in March 2008 include obligatory product sealing and a ban on medicine repackaging. “The need for action is urgent, no further time can afford to be lost if patients lives are to be protected” added Mr Murphy.
Self-medication industry endorses move by pharmacists to re-professionalise their business Speaking at the 44th Annual Meeting of the Association of the European SelfMedication Industry (AESGP) in Stockholm, Anne Nolan, IPHA Chief
Executive welcomed moves by pharmacists to re-professionalise pharmacy practice and services in Ireland. According to Ms Nolan "To enhance and broaden their professional role pharmacists are working to re-position themselves as first-line healthcare advisors by highlighting value-added services such as free consultations on minor ailments, investing in health screening facilities and conducting health promotion campaigns.” State led attempts to improve the delivery of pharmacy services, through the
Pharmacy Act 2007, coupled with the changing needs and healthcare expectations of consumers, have presented pharmacists with a golden opportunity to re-position the profession. "IPHA has lent concrete and practical support over the last few years to pharmacists' efforts to reinforce their image and role "as first port of call" through effective training and consumer awareness campaigns. If successful, pharmacy will be seen in its rightful place, truly at the core of healthcare in Ireland, serving all the healthcare needs of the community" concluded Ms Nolan.
Anne Nolan, IPHA Chief Executive presenting on “Innovation in Pharmacy” at the 44th Annual Meeting of the Association of the European Self-Medication Industry (AESGP) in Stockholm.
IPHA welcomes new member to its Strategy Board Ms Loretto Callaghan B.Sc. M.Sc. Dip. Marketing recently joined the IPHA Prescription Medicines Division Strategy Board Loretto is Managing Director with Novartis Ireland Limited. Loretto has worked in the pharmaceutical industry for almost 20 years in both the UK and Ireland in various sales, marketing and senior management roles before taking up her current position in January 2006. Loretto holds an M.Sc. in Toxicology from Trinity College Dublin, a B.Sc. in Pharmacology from UCD and a Diploma in Marketing from the Chartered Institute of Marketing, UK.
10th IPHA charity golf event a big success Over €23,000 was raised at the 10th IPHA charity golf event, in aid of the Niall Mellon Township Trust. A total of 23 teams entered the event at the Glen of the Downs Golf Club, Delgany, Co Wicklow. This brings the total raised by IPHA in the last 10 years, for various deserving causes, to over €210,000. Speaking about this year’s event IPHA Chief Executive Anne Nolan said: “IPHA and the pharmaceutical industry in Ireland are proud to be associated with this worthwhile charity. Set-up to eradicate urban poverty in South Africa by building sustainable community townships, the Niall Mellon Township Trust has provided essential support in townships such as community facilities and technological infrastructures. This has given the people living in these areas a better quality of life and better health and makes us proud to support it.”
From left to right: Mary Power, Mark Ryan, Anne Nolan, Dr Jim Kiely
Winning Teams: 1st 2nd 3rd
Merck Sharpe & Dohme Ireland (Human Health) Limited Irish Pharmaceutical Healthcare Association Cahill May Roberts
Individual prizes: Longest drive: Men – James Kavanagh, Abbott Laboratories (I) Ltd Women – Anne Nolan, IPHA
Nearest the Pin: Men – Andrew Gawman, Reckitt Benckiser Healthcare (Ireland) Women – Mary Power
Government recognises valuable contribution of pharmaceutical companies’ activities in the developing world In recent years, IPHA has provided the Minister for Foreign Affairs and the Minister for Overseas Development with reports on the growing number health partnerships and programme the pharmaceutical industry is involved in in the developing world. Today, pharmaceutical companies globally are involved in 155 health partnerships and programmes in the developing world which are designed primarily to improve access to medicines and other aspects of healthcare. The industry has made available medicines, vaccines, equipment, training and health education worth $6.7 billion to the developing world since the United Nations announced the Millennium Development Goals. The Department of Foreign Affairs recently acknowledged the industry’s role stating that “Ireland recognises the valuable contribution that public private partnerships (PPPs) involving pharmaceutical companies can and do make in low income countries. This is borne out in our first hand experience of support to a number of global PPPs developing new and better drugs and diagnostics for diseases of poverty, especially HIV & AIDS, tuberculosis and malaria. Your [the pharmaceutical industry’s] interest in global health and health in developing countries is encouraging”.
The Roche Phelophepa Health Care Train underway in rural South Africa. The train provides urgently needed medical care to people in remote villages. And below is the waiting area for the Roche Health Clinic on the Phelophepa train.
The inequality of access to healthcare remains one of the biggest challenges facing the world today. The pharmaceutical industry is aware that it has a significant role to play, but responsibility also rests with Governments and other organisations to provide appropriate infrastructures that support
good public health and reliable provision of medicines and other aspects of healthcare to those in need. The industry looks forward to continuing to work in partnership with others in meeting these challenges. For more information on the various health partnerships the pharmaceutical industry is involved in visit www.ifpma.org/healthpartnerships.
Medicines Matter is published by the Irish Pharmaceutical Healthcare Association (IPHA) which represents the international research-based pharmaceutical industry in Ireland. Its member companies include both manufacturers of prescription medicines and non-prescription or consumer health care medicines. Irish Pharmaceutical Healthcare Association Franklin House 140 Pembroke Road Dublin 4 Ireland Tel: (353 1) 660 3350 www.ipha.ie Fax: (353 1) 668 6672 www.medicines.ie E-mail: info@ipha.ie www.feelbetter.ie
Content: Anne Nolan, Brian Murphy, Ronan Collins, Michelle Kurtz, Rebecca Cramp Publisher: © Irish Pharmaceutical Healthcare Association Ltd Design and production: Slick Fish Design, Dublin