The Irish Pharmaceutical HealthcareAssociation (IPHA) and the Irish PharmacyUnion (IPU) in association with Age ActionIreland launched a campaign this monthto help older people know more abouttheir medicines.

Understanding how medicines work andtaking medicines properly can have adramatic effect on older people’s lives andwell-being, helping them stay healthy andlive independently in the community forlonger. If older people are not taking theirmedicines properly, they are less likely torecover from illness and more likely to endup in hospital. If this is happening over aprolonged period and the patient’s healthand quality of life deteriorates, they areno longer able to live independently inthe community and often need to moveinto hospital or nursing home care withincreased direct and indirect costs to theState.

We know that the use of medicinesincreases with age. In fact 47% of allprescribed medicines are taken by olderpeople. We also know that older peopleare two to three times more at risk, thanyounger adults, of having an adversereaction to a medicine.

The ‘Master Your Medicines’ campaignseeks to lower that risk by encouragingolder people to speak to their pharmacist,learning about their medicines and raisingany concerns that they may have withthem. By doing this older people will be ina better position to get the maximumbenefit from their medicines.

IN THIS ISSUE

matterMEDICINES

October 2008

New IPHA PresidentCounterfeit medicines

Ireland needs a clinical research “supremo”and more...IPHA Charity Golf

Helping older people knowmore about their medicines

Members of the LucanRetirement Group withtheir local pharmacistat the launch of theMaster Your Medicinescampaign.

The campaign elements include:

- An information booklet which isavailable from pharmaciesnationwide. It provides informationon all aspects of taking medicinesincluding information on medicinesand falls, information for carers anda Patient Medication Record;

- A Medicines Reminder Chart whichis available for download fromwww.ipha.ie; and

- A national radio infomercialencouraging older people to speakto their pharmacist about theirmedicines.

IPHA has enhanced www.medicines.ieand the Medicines Compendium2008/2009 CD-ROM by including aspecific page on Adverse ReactionReporting which links directly to theIrish Medicines Board (IMB) website.This is part of an initiative, incollaboration with the IMB, toincrease health professional reportingof suspected adverse reactions.

Commenting on the collaboration,IPHA’s Scientific & Regulatory AffairsManager Rebecca Cramp PhD statedthat: “The reporting by healthcareprofessionals, of suspected adversereactions that occur after a product islicensed, is very important to facilitatethe assessment of the evolvingbenefit/risk profile of a medicine overits lifetime and we hope that the linkfrom www.medicines.ie to the IMB’swebsite will enhance that process.”

The Medicines Compendium2008/2009 CD-ROM is a copy of thesuccessful IPHA medicines.ie websitewhich provides up to the minuteinformation on prescription and ‘over-the-counter’ (non prescription)medicines. The CD-ROM is primarilydesigned for those who do not haveready internet access in their practice.

The CD-ROM is sent annually, free ofcharge, to 6,500 GPs, Consultants andcommunity and hospital pharmacistsin the country. The CD-ROM providesindependent, IMB/EMEA approvedinformation on over 2,000 medicinescurrently available in Ireland. It allowsthe user to access information aboutthe medicines available in Ireland –such as what they are indicated totreat, possible adverse reactions andhow one medicine might interact withanother.

If you would like to order a copy ofthe Medicines Compendium2008/2009 please contact compendium@ipha.ie.

New IPHA PresidentDr Gerald Farrell has been appointedPresident of the Irish PharmaceuticalHealthcare Association (IPHA).

Gerald is currently Managing Director forEli Lilly in the Republic of Ireland, havingjoined the company, a leading innovation-driven pharmaceutical corporation in1989. He has held various positionsincluding assignments in new productplanning, market research, salesmanagement and manufacturing both inthe UK and Ireland. Prior to his currentposition he was Director of Strategy,Commercial & Business Information from1999 to 2003 in the UK.

Upon taking office Gerald said that “Thepharmaceutical industry’s commitment to

meeting the needs of patients isunequivocal. It is our responsibility tomeet their needs and provide them withnew and better medicines to treatdisease. As we face into a challengingperiod IPHA will continue to build on thesuccessful partnerships developedbetween the industry, the State and itsvarious agencies in order to ensure thatpatients continue to have access to thesenew and better medicines.”

Gerald has a PhD in Biotechnology fromUniversity College Cork and a BSc in PlantScience from University College Galway(National University of Ireland, Galway).

He will hold the position of IPHAPresident for a term of two years.

IPHA and IMB collaborate to improvereporting of suspected adverse reactions

Doctor Gerald Farrell

RecommendationsFive clear individualrecommendations emerged fromthe discussions:

1. Standardise Ireland’s system ofEthical Review Committees, andremove their unpredictability.

2. Create formal career structuresfor health professionalsinterested in research, especially(but not only) for research nurses.

3. Integrate internationallyaccredited training in GoodClinical Practice into medical andnursing education at all levels.

4. Introduce practical and standardindemnity arrangements forclinical trials, in particular for non-commercial clinical research.

5. Make research a core value inhealthcare.

…and one overarchingrecommendation

6. Appoint a clinical research“supremo” in the Department ofHealth and Children with thepower to remove the roadblocksand create and deliver a researchstrategy for health in Ireland.

More than 200 delegates from patients’organisations, industry, science and publicpolicy met recently in Dublin Castle todiscuss how Ireland may become globallycompetitive in clinical research. Themeeting was organised by the IrishPlatform for Patients’ Organisations,Science and Industry (IPPOSI) inassociation with IPHA.

Delegates were addressed by Minister forHealth and Children, Mary Harney, TD,who stressed the value of collaboration:“In a country as small as this I’minterested in people working together.”Everybody has a common goal, she said –to improve healthcare and improve accessto new medicines, and that, she said,makes research “very much a front-lineactivity”.

IPPOSI Chair Michael Griffith stressed thatIrish patients want a world-class clinicalresearch infrastructure in Ireland – and hereminded the audience that we are all, orat some time will be, patients.

Yet in Ireland the lack of thatinfrastructure contrasts sharply withIreland’s position as one of the world’smost attractive locations forpharmaceutical manufacturing. Worse, asAnne Nolan, CEO of IPHA, said, Ireland islosing its attractiveness for clinicalresearch. The result, she said, is that “Irishsubsidiaries find it increasingly difficult tocompete internally, to convince corporateheadquarters to conduct clinical researchin Ireland.”

Other industry speakers mooted similarconcerns. For Dr. John Stinson, MedicalDirector of LEO Pharma, Ireland had manystrengths, with big changes in the past 12

years. He pointed to high standardsamong clinicians and scientists, altruisticpatients and population, a desire to thinkcreatively and, from pharma, a greathunger for trials and funding.

But, he said, there were many weaknesseson indemnity, Ethics Committees,different requirements for submissions,the freeze on recruiting clinical staff; andin relation to the lack of career structuresand training, especially in Good ClinicalPractice. “We all say the right things,”said Stinson, “but do we really walk thewalk?”

“There are opportunities”, said Stinson,“with more consultants and much betterhospitals than 20 years ago, morefunding for science and anentrepreneurial population”. Thechallenge is to move up the value chain,more towards Phase II rather than PhaseIII trials. And there are threats: newcountries joining the EU, Ireland’s smallpopulation, the lack of protected time forresearch and the shortage of clinicalresearch positions. For patients, that couldadd up to fewer opportunities to takepart in clinical trials and less access to thenewest medicines, especially for rarerdiseases.

Dr. John Farrell, Medical Director of Pfizer,said we need to be clear about what wecan deliver and what we cannot. “Weneed to be able to persuade Pfizer NewYork that Ireland is a good place to investmoney in…If Pfizer does trials in the UKand they fail, they will still do more. If wefail in Ireland it will be much more difficultnext time around,” he said.

That means looking at infrastructure –especially people, “and especially researchnurses”. It is still, said Farrell, “extremelydifficult” to get good people to work inresearch and industry. But it has to bedone: “Clinical research shouldn’t be seenas something nice to have but somethingthat Ireland should be involved in.”

The good news, from the conference, isthat all the building blocks of a goodinfrastructure seem to be in place, withhuge investment in recent years. Buildingblocks are not enough however: Irelandalso needs to provide strong leadershipfor a clear national strategy that canremove the barriers and, take advantageof the real opportunities that exist.

Consensus – on where the problems lieand what the solutions might be – was

not hard to find. On the contrary, theremarkable thing about the day’sdiscussion was the extent of agreement.Equally remarkable - the proposedsolutions are not only straightforward,they are not inherently expensive.

Ireland needs a clinical research “supremo”

Anne Nolan, IPHA Chief Executive speaking at theClinical Research Conference.

Minister for Health and Children, Mary Harney TD addressingdelegates at the Clinical Research Conference.

actors are now operating internationallyor through the Internet and thereforeoutside the jurisdiction of nationalregulators” added Mr Murphy

The lack of integrity in the supply chain isseen as a facilitating factor. There is noaccurate data on the scale of counterfeitsin the pharmaceutical sector because theyare mainly sold and used in unofficial anduncontrolled settings, thus making themdifficult to detect. Or where controls andregulations do exist, reporting is sporadicand not centralised.

Strong EU measures to tackle thisgrowing threat, including a ban onmedicine repackaging, a harmonised EU-system of identification of medicines, andheavier penalties for trafficking incounterfeit medicines are requiredimmediately.

The World Health Organisation (WHO)estimates that 8% to 10% of themedicines in the global medicine supplychain are counterfeit, reaching as high as25% in some countries. The largestcounterfeit market with close proximity tothe EU is Russia, where it is estimatedthat 12% of medicines are counterfeit.

An increasing conduit being used bycounterfeiters is the Internet. An in-depth

report by the European Alliance forAccess to Safe Medicines (EAASM)entitled the Counterfeiting Superhighway, examining internet pharmacies andlifesaving medicines purchased online,revealed that a frightening 62% ofmedicines purchased online are fake orsubstandard. These include medicinesindicated to treat serious conditions suchas cardiovascular and respiratory disease,neurological disorders, and mental healthconditions.

Mr Murphy said in response to theEAASM report that “Patients must beencouraged to purchase prescriptionmedicines through authorised distributionchannels only. Only then can patients beguaranteed to be getting a genuinepharmaceutical product.”

Proposals for tougher EU legislation areexpected before the end of 2008, as partof a new ‘pharmaceutical package’ beingdeveloped by the European Commission.Options outlined by the Commission in itspublic consultation document in March2008 include obligatory product sealingand a ban on medicine repackaging.

“The need for action is urgent, no furthertime can afford to be lost if patients livesare to be protected” added Mr Murphy.

Recently released EU statistics show thatover four million medicinal products wereseized at EU customs borders in 2007.This was an increase of 51% on the 2006figure. While Internet-based sales are themain source of counterfeit medicines,these products are being encountered atall stages of the supply network:manufacture, distribution and entrythrough wholesalers, pharmacists and theblack market.

Mr Brian Murphy, IPHA Director ofCommercial Affairs said the figures showthat international traders are continuingto take advantage of more open bordersand new technologies such as theInternet to conduct their criminal businesswithout any scruple for people's health.Though traditionally rare in Europe, thisgrowing threat needs to be tackled, inparticular, by making the entire Europeanpharmaceutical supply chain as tight andsecure as possible.

Counterfeit medicines are any medicinesand active pharmaceutical ingredients(APIs) that are deliberately andfraudulently mislabelled by unauthorisedparties with respect to source, and / orcomposition and / or therapeutic quality.They have been found to contain toxicsubstances, no active ingredient, or thewrong amount of it. Life-saving medicinesare increasingly targeted, includingmedicines to treat cancer and heartdisease, psychiatric disorders, andinfections.

“Counterfeiting is attractive because it is alucrative activity with little risk of beingcaught. Globalisation has lead to relaxedbarriers to trade facilitating the circulationof counterfeit products and a plethora of

Counterfeit medicines pose a growingthreat to European patient’s health

Self-medication industry endorses move bypharmacists to re-professionalise their business

Speaking at the 44th Annual Meeting ofthe Association of the European Self-Medication Industry (AESGP) inStockholm, Anne Nolan, IPHA Chief

Executive welcomed moves bypharmacists to re-professionalisepharmacy practice and services in Ireland.

According to Ms Nolan "To enhance andbroaden their professional rolepharmacists are working to re-positionthemselves as first-line healthcare advisorsby highlighting value-added services suchas free consultations on minor ailments,investing in health screening facilities andconducting health promotioncampaigns.”

State led attempts to improve the deliveryof pharmacy services, through the

Pharmacy Act 2007, coupled with thechanging needs and healthcareexpectations of consumers, havepresented pharmacists with a goldenopportunity to re-position the profession.

"IPHA has lent concrete and practicalsupport over the last few years topharmacists' efforts to reinforce theirimage and role "as first port of call"through effective training and consumerawareness 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 thecommunity" concluded Ms Nolan.

Over €23,000 was raised at the 10thIPHA charity golf event, in aid of theNiall Mellon Township Trust. A total of23 teams entered the event at the Glenof the Downs Golf Club, Delgany, CoWicklow. This brings the total raised byIPHA in the last 10 years, for variousdeserving causes, to over €210,000.

Speaking about this year’s event IPHAChief Executive Anne Nolan said:“IPHA and the pharmaceutical industryin Ireland are proud to be associatedwith this worthwhile charity. Set-up toeradicate urban poverty in South Africaby building sustainable communitytownships, the Niall Mellon TownshipTrust has provided essential support intownships such as community facilitiesand technological infrastructures. Thishas given the people living in theseareas a better quality of life and betterhealth and makes us proud to supportit.”

IPHA welcomes new member to its Strategy BoardMs Loretto Callaghan B.Sc. M.Sc. Dip. Marketing recently joined the IPHA PrescriptionMedicines Division Strategy Board

Loretto is Managing Director with Novartis Ireland Limited. Loretto has worked in thepharmaceutical 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 inJanuary 2006.

Loretto holds an M.Sc. in Toxicology from Trinity College Dublin, a B.Sc. inPharmacology from UCD and a Diploma in Marketing from the Chartered Institute ofMarketing, UK.

10th IPHA charity golf event a big success

From left to right: MaryPower, Mark Ryan, AnneNolan, Dr Jim Kiely

Winning Teams:1st Merck Sharpe & Dohme Ireland (Human Health) Limited2nd Irish Pharmaceutical Healthcare Association3rd Cahill May Roberts

Individual prizes:Longest drive: Men – James Kavanagh,Abbott Laboratories (I) LtdWomen – Anne Nolan, IPHA

Nearest the Pin: Men – Andrew Gawman,Reckitt Benckiser Healthcare(Ireland)Women – Mary Power

Anne Nolan, IPHA Chief Executive presenting on “Innovation in Pharmacy” at the 44th AnnualMeeting of the Association of the European Self-Medication Industry (AESGP) in Stockholm.

Irish Pharmaceutical Healthcare Association

Content:Anne Nolan, Brian Murphy, Ronan Collins, Michelle Kurtz, Rebecca CrampPublisher: © Irish Pharmaceutical Healthcare Association LtdDesign and production: Slick Fish Design, Dublin

Franklin House140 Pembroke RoadDublin 4Ireland Tel: (353 1) 660 3350 Fax: (353 1) 668 6672 E-mail: info@ipha.ie

www.ipha.iewww.medicines.iewww.feelbetter.ie

Medicines Matter is published by the Irish Pharmaceutical Healthcare Association (IPHA) which representsthe international research-based pharmaceutical industry in Ireland. Its member companies include bothmanufacturers of prescription medicines and non-prescription or consumer health care medicines.

Today, pharmaceutical companies globallyare involved in 155 health partnershipsand programmes in the developing worldwhich are designed primarily to improveaccess to medicines and other aspects ofhealthcare. The industry has madeavailable medicines, vaccines, equipment,training and health education worth $6.7billion to the developing world since theUnited Nations announced theMillennium Development Goals.

The Department of Foreign Affairsrecently acknowledged the industry’s rolestating that “Ireland recognises thevaluable contribution that public privatepartnerships (PPPs) involvingpharmaceutical companies can and domake in low income countries. This isborne out in our first hand experience ofsupport to a number of global PPPsdeveloping new and better drugs anddiagnostics for diseases of poverty,especially HIV & AIDS, tuberculosis andmalaria. Your [the pharmaceuticalindustry’s] interest in global health andhealth in developing countries isencouraging”.

The inequality of access to healthcareremains one of the biggest challengesfacing the world today. Thepharmaceutical industry is aware that ithas a significant role to play, butresponsibility also rests with Governmentsand other organisations to provideappropriate infrastructures that support

good public health and reliable provisionof medicines and other aspects ofhealthcare to those in need. The industrylooks forward to continuing to work inpartnership with others in meeting thesechallenges.

For more information on the varioushealth partnerships the pharmaceuticalindustry is involved in visit www.ifpma.org/healthpartnerships.

Government recognises valuable contribution ofpharmaceutical companies’ activities in the developing worldIn recent years, IPHA has provided the Minister for Foreign Affairs and the Minister forOverseas Development with reports on the growing number health partnerships andprogramme the pharmaceutical industry is involved in in the developing world.

The Roche Phelophepa Health Care Train underway in rural South Africa. The train provides urgently needed medicalcare to people in remote villages. And below is the waiting area for the Roche Health Clinic on the Phelophepa train.