Self-Care First A Self-Care Framework for Ireland 20121 SELF-CARE FIRST A Self-Care Framework for Ireland proposed by theSwitch-On to Self-Care Working Group Self-Care First A Self-Care Framework for Ireland 20122 SELF-CARE FIRST EXECUTIVE SUMMARY FollowingonfromtheestablishmentoftheSwitch-OntoSelf-CareWorkingGroup,its membersagreedthatthebestapproachwouldbetoproposeaSelf-CareFrameworkfor Ireland.ThisdocumentreflectstheWorkingGroupsvisionthatinhealthcare,self-care should come first. The definition of self-care for the purpose of establishing the proposed Self-Care Framework is the care taken by individuals of their own health and well being. This Framework is based on six pillars: 1 Stay fit and maintain good physical and mental health 2 Meet social and psychological needs 3 Prevent illness or accidents 4 Avoid unnecessary risks 5 Use over the counter (OTC) medicines to treat minor ailments 6 Reduce the risk of long-term conditions The Switch-On to Self-Care Working Group recommends the following actions to support the Self-Care Framework: 1.Legislators need to place a high value on the role of self-care in the healthcare system; 2.Theregulatoryenvironmentmustbebalanced,proportionateandfocusedonmeetingthe needs and expectations of patients and other stakeholders; 3.Healthcareprofessionalsshouldbeencouragedtosupportandfacilitatetheconceptof self-care; 4.The role of the pharmacist should be expanded; 5.Patients should have access to good quality information so that they are fully empowered and confident to embrace self care, seek care at the appropriate level and, thus, enhance their independence within the healthcare system; 6.Therangeofmedicinesmadeavailabletopatientsshouldbeexpandedthrough switching1.

1Switchingistheprocessofexpandingself-medicationthroughachangeinthemethodofsupplyofsome medicines from prescription-only to pharmacy-only status. Self-Care First- A Self-Care Framework for Ireland 2012 1 Self-Care First A Self-Care Framework for Ireland 20123 1. INTRODUCTION AtameetingentitledSwitch-OntoSelf-Care,heldin2009,allthestakeholderspresent agreed that it was necessary to explore how the benefits to public health and the healthcare systemofgreaterutilisationofself-careandself-medicationinIrelandcouldbemorefully realised. Following on from this meeting, a Switch-On to Self-Care Working Group (see Annex 1) was established.Itiscomposedofrepresentativesfrom keystakeholderorganisationsincluding theIrishPharmacyUnion(IPU),theSchoolofPharmacyandPharmaceuticalSciencesat TrinityCollegeDublin,theDepartmentofGeneralPracticeatUniversityCollegeCorkand representatives of the pharmaceutical industry. It also includes an observer from the Health Service Executive (HSE). In its first meeting, the Working Group agreed that the best approach would be to propose a Self-CareFrameworkforIrelandandtousethatinordertoadvocateforchangeand/or action. This document reflects the Working Groups vision that in healthcare, self-care should come first.2

2. BACKGROUND HealthcareinIrelandisgoingthroughaperiodofsignificantchangeanincreasingand ageing population, evolving health structures, greater private sector involvement in the health arena,agrowingincidenceofchronicdiseases,everincreasingpublicexpectationsofthe service and the development of new treatments which offer hope to patients but which also poseastrongfinancialchallengetotheState.Thischallengeiscompoundedfurthergiven thecurrentstateofthepublicfinancesandtheStatesrequirementtocontrolhealthcare expenditure. InIreland,conditionslikecardiovascularandchronicrespiratorydiseases,diabetesand obesity,whichconstitutethebiggestburdenonthehealthbill3,areoftencausedbyknown and avoidable risk factors, such as an unhealthy diet, a lack of physical activity and smoking. Clearly,effectivepreventionintheseareaswouldsignificantlyreducetheburdenthese diseaseshaveonthehealthcaresystem4.AttheestablishmentoftheHSEsQualityand ClinicalCareDirectorate,whichheraldedtheestablishmentof20programmesunderthe leadership of a multi-disciplinary team of clinical experts, Dr Barry White indicated the group wasfocusingonsolutionswhichwillimprovepatientcare,removewaitinglistsandsave money. Thisiswhereself-carecomesintoplay.Wenowliveinaworldwhereifaconditionis diagnosedearly,itcanoftenbequickly,effectivelyandefficientlytreatedusingmodern medicines, other medical interventions and behaviour modification. We are at a crucial point as a society and unless small but significant changes in the behaviour of adults and children areencouragedwefaceapotentialhealthcrisiswhichcouldoverwhelmthesysteminthe years ahead5.

2The framework reflects similar work undertaken in the UK by the Self Care Campaign which was established in March 2009. For their proposals see Self Care: Ethical Imperative http://www.selfcarecampaign.org/uploads/20100316_self_care_campaign_white_paper.pdf 3TacklingChronicDiseaseAPolicyFrameworkfortheManagementofChronicDiseasesDepartmentof Health and Children 2008 4 Approximately 80% of GP consultations and 60% of hospital bed days are related to chronic diseases and their complications. Chronic diseases account for two thirds of emergency medical admissions to hospitals. 5 For example, the Survey of Lifestyle, Attitudes and Nutrition (SLAN) Report of 2007 estimated that over 39% of Irishadultsareoverweightand25%areobese.AccordingtotheNationalTaskforceonObesityof2005, estimates for Irish children are also very worrying with more than 300,000 thought to be overweight and obese, with the number increasing at a rate of over 10,000 a year. The Taskforce estimated that about 2,000 deaths a 2 Self-Care First- A Self-Care Framework for Ireland 2012 Self-Care First A Self-Care Framework for Ireland 20124 Self-careisnotonlyabouttreatingillnessbutalsoaboutencouragingpeopletotakebetter care of their own health. Harvard Professor Dr David Nathan completed a three-year clinical trialstudying3,000peoplewhoalthoughnotdiagnosedasdiabetics,wereoverweightand hadelevatedbloodglucoselevels.TheStudyfoundthatparticipantswhomadelifestyle changes lowered their risk of developing the disease by 58%. These changes were relatively small - they walked about 30 minutes, five evenings a week and lost about 7% of their body weightonlyabout15 poundseach. Theimpactof thelifestylechangeswasevengreater among people over the age of 60, where the risk of diabetes was reduced by 70%6. AlthoughnoeconomicstudieshavebeencarriedoutinIreland,studieshavebeencarried out in other jurisdictions to measure the aggregate cost savings of OTC medicines as used for the mostcommonself-treatableconditionsandtheir resultsare relevanttoIreland. One study in the US evaluated how consumers wouldtreat these conditions if they did not have accesstoOTCmedicines.Thestudyidentifiedconsiderablesavingsfromavoidedclinical visitsanddiagnostictestingandtheuseoflesscostlyOTCmedicines,ratherthan prescriptionmedicines.Thestudyalsofoundthatbykeepingtheworkforcehealthyandat work,OTCmedicinesofferedpotentialadditionalproductivitybenefitsfromdoctorsvisits avoided and time not having to be away from work for medical appointments.7 A further UK study has shown that GP treated ailments that could be self-treated are costing the NHS 2 billion every year 8

Simpleandstrategicchangesinthewayself-careisdefinedandorganisedinIrelandcan make a difference to the long-term well being of the Irish people. 3. SELF-CARE FRAMEWORK In2001,theGovernmentpublishedPrimaryCareANewDirection9.Init,primarycare wasdefinedas:Anapproachtocarethatincludesarangeofservicesdesignedtokeep peoplewell,frompromotionofhealthandscreeningfordiseasetoassessment,diagnosis, treatmentandrehabilitationaswellaspersonalsocialservices.Theservicesprovidefirst-level contact that is fully accessible by self-referral and have a strong emphasis on working with communities and individuals to improve their health and social well-being. The objective of the 2001 primary care strategy was to provide forces to run counter to those drivingpeopleintosecondarycare(seeFigure1below),i.e.tomovecare,where appropriate,fromsecondarytoprimarylevel,fromprimaryleveltoselfcareandfromself care to a no care requirement.

yearcouldbeattributedtoobesityandthenumbersweregrowingrelentlessly.Itestimatedthatthesedeaths alone may be costing the State as much as 4 billion per year. 6WallStreetJournalThemedicalcommunitywantsyoutobescaredofdiabetesbutnottooscared(23rd September 2003) 7www.yourhealthathand.org/images/uplpoads/The_Value_of_OTC_Medicine_to_the_United_States_BoozCo.pdf 8 Minor ailment workload in general practice; December 2007; IMS Health 9 Primary Care. A New Direction. Quality and Fairness a health system for you, Health Strategy, Department of Health and Children, 2001. Self-Care First- A Self-Care Framework for Ireland 2012 3 Self-Care First A Self-Care Framework for Ireland 20125 The definition of self-care for the purpose of establishing the proposed Self-Care Framework is the care taken by individuals of their own health and well being. This Framework is based on six pillars: 1 Stay fit and maintain good physical and mental health 2 Meet social and psychological needs 3 Prevent illness or accidents 4 Avoid unnecessary risks 5 Use over the counter (OTC) medicines to treat minor ailments 6 Reduce the risk of long-term conditions Providingforcestoruncountertothosedrivingpeopleintosecondarycareispossible because,inIreland,patientsarenolongerpassiverecipientsofhealthcareandadvice. Instead, they want to become more knowledgeable about their health, with better access to quality information about illnesses (prevention and treatments) and gain more control about decisions affecting their health. Irish patients are particularly well-prepared to handle self-medication. The attitudes of people to self-care in Ireland were presented at the Switch-On to Self-Care conference held in 2009, which featured data from Irish respondents in an international survey carried out by Nielsen10 and shed some light on their behaviour towards OTC medications.

10SelfMedication&SelfCare:AMulti-CountryStudyExploringConsumerAttitudes&Behaviours,Robert Buckeldee, Nielsen, 2009. 4 Self-Care First- A Self-Care Framework for Ireland 2012 Self-Care First A Self-Care Framework for Ireland 20126 From the responses gathered, it was concluded that the Irish patient is more open to a multi-strandedhealthcareengagement(manufacturers,doctors,pharmacies,government)than theEuropeanaverageandthiswillenabletheburdenofhealthawarenesstobeshared across all relevant parties. ThestudyfindingsalsoshowedthatIrelandhasthehighestincidenceofminorailmentsin Europe,with3.5outof alistof14minorailmentsidentifiedasaffecting respondentsinthe previousmonth. That maybewhypatientstendedtobemorediscerningas theirchoice of OTCmedicineswasguidedbytheirconfidenceintheproduct(45%ofIrishrespondents versusanaverageof33%ofWesternEuropeanrespondents)andbywhetherthey considered it safe (44% of Irish respondents versus 36% of Western European respondents). Irish patients see health education and advice from the pharmacist as key ways to help them take care of their health and minor ailments. The confidence that Irish patients have in their pharmacistmaybecoupledwiththefactthattheyleadthewayinEuropeintheviewthat moremedicinesshouldbemadeavailablewithoutaprescriptionfromthedoctor.Itisthe only country where a majority of respondents agreed. Further research findings, published in April 2010 by the Irish Medicines Board (IMB), looked athowconsumerssourceinformationaboutthemedicinestheytakeandfoundthat3in4 Irish adults read product information before taking new medicines11. This demonstrates that Irish patients are being proactive when it comes to seeking information about their health. 4. RECOMMENDATIONS Takingintoconsiderationtheaboveremarks,theSwitch-OntoSelf-CareWorkingGroup recommends the following: 1.Legislatorsneedtoplaceahighvalueontheroleofself-careinthehealthcare system The 2001 Government Health Strategy included a series of proposals to promote health and well being. Some of these, such as those around smoking and alcohol, have been or arecurrentlybeingimplemented.TheSwitch-OntoSelf-CareWorkingGroupbelieves thatotherinitiatives,inparticulararoundthepromotionofchildrenshealthandmens health, now need to be taken forward to ensure that healthcare is delivered at the lowest appropriate level. The recommended actions include: i.Intensivehealthpromotionfromanearlyagethroughschoolandintothe workforce. Clear measurable targets are necessary for proper evaluation; ii.Theencouragementofphysicalexercise,notjustinthesenseofcompetitive sportsbutalsointermsofwalkingorswimming,asaroutinepartofahealthy lifestyle; iii.Theprovisionofappropriatefundingtogeneralpractitionerstoengagein preventive medicine and to encourage pharmacists to be further involved in health promotion initiatives.

11 Consumer Views on Sourcing Information about Medicines National Survey Results, Irish Medicines Board, April 2010. Self-Care First- A Self-Care Framework for Ireland 2012 5 Self-Care First A Self-Care Framework for Ireland 20127 2.Theregulatoryenvironmentmustbebalanced,proportionateandfocusedon meeting the needs and expectations of patients and other stakeholders12 The need to manage quality, safety and efficacy of medicines should be balanced by the positivehealthbenefitstosocietyoftheincreasedavailabilityofover-the-counter medicines. 3.Healthcareprofessionalsshouldbeencouragedtosupportandfacilitatethe concept of self-care Thiscouldconsistofajointdeclarationofcommitmentbythevariousorganisationsof healthcareprofessionalsandalliedhealthcareprofessionalstocoordinatetheirwork more closely in order to ensure that patients access treatment at the lowest appropriate levelratherthan,astoooftenhappens,seekingtreatmentatahigherlevelthan required. 4.The role of the pharmacist should be expanded PharmacistscouldplayakeyroleinthisnewFrameworkinprovidingsufficient informationandsupporttoenablepatientstomakeaninformedchoice.Pharmacists couldundertakestrongeradvisorypositionsintheircommunity,includingthepossible actions outlined below: i.ThedevelopmentofMinorAilmentSchemesthatwouldenablemedicalcard (GMS)patientstoreceivetreatmentofcommonillnessesfreeofcharge,direct from their community pharmacist; ii.Theprovisionofevidence-basedpreventionandhealthpromotionactivities,as recommended by the Pharmaceutical Society of Irelands Pharmacy Ireland 2020 Working Group Interim Report; iii.The enhancement of the pharmacists advisory role to support compliance and in ensuring that the right medicine is advised to patients for the right purpose. iv.Theregulationofpharmacyhasincreasedsignificantlyinrecentyearsand pharmacistshaverisentothechallengeofincreasedcomplianceandthe responsibilities entailed. This increased regulation and pharmacist demonstration ofcontinuedcompetencyhashighlightedthatthepharmacyisanenvironment wherereclassifiedproductscansafelybesupplied.Itwouldfollowthatmore products should be reclassified to Pharmacy Only supply to allow pharmacists to fulfil their role as fully as possible. Thisexpandedadvisorypositionhasthepotentialtocomplementtheroleofother healthcareprofessionals,inparticularGPs,andgiventhatallpharmaciesfromthe1st November 2010 have private consultation areas they have appropriate facilities to allow them greater one-to-one interaction with patients. 5.Patientsshouldhaveaccesstogoodqualitytrustworthyinformationsothatthey arefullyempoweredandconfidenttoembraceselfcare,toseekcareatthe appropriateleveland,thus,toenhancetheirindependencewithinthehealthcare system Currently, thereare feweducationalcampaigns centredaroundthebenefitsofself-care toenticethepublictobemoreproactivelyinvolvedinself-care.Itistheviewofthe Switch-On to Self-Care WorkingGroup that it is essential thatall stakeholders including

12TheSwitch-OntoSelf-CareWorkingGroupnotestheestablishmentofaConsultativePanelontheLegal Supply Classification of Medicines by the IMB which is currently deliberating 6 Self-Care First- A Self-Care Framework for Ireland 2012 Self-Care First A Self-Care Framework for Ireland 20128 theHealthServiceExecutive(HSE),inparticularthePopulationHealthdepartment, relevantpatientandconsumerorganisations,professionalmedicalandpharmacy organisations (IPU, ICGP, IMO etc.), regulators (IMB and PSI) and industry should work togetheronhealthpromotioncampaignscentredaroundself-caretocommunicatethe following key messages to the public: i.Stay healthy through illness prevention and wellness; ii.SeekadvicefromapharmacistwhenusingOTCmedicinesinordertoensure safeuse,particularlyforproductswhosemethodofsupplyhasrecentlybeen changed from prescription-only to OTC. The pharmaceutical industry playsan importantrole in providingtrustworthyinformation to patients and is already offering quality information through thewww.medicines.ie web portal,throughpatientinformationleafletswhichaccompanyallmedicines,through disease awareness campaigns and consumer advertising of some OTC medicines. 6.Therangeofmedicinesmadeavailabletopatientsshouldbeexpandedthrough switching Irelandshouldadoptapartnershipwithrelevantstakeholdersinordertodiscusswhat steps need to be taken to make more OTC medicines available in order to enhance the appropriateuseofself-medication,supportedbyincreasedlevelofadviceby pharmacists.ThepartnershipmodeldevelopedinrecentyearsintheUK,involvingthe regulator, pharmacy and doctors bodies, the industry and patient groups, has shown the possibilitiesforexpandingself-medicationthroughachangeinthemethodofsupplyof somemedicinesfromprescription-onlytopharmacy-only(aprocessknownas switching).13Thisledtothepreparationofalistofpotentialcandidatesforswitching, backgroundinformationabouttheprocessandareportoutliningtheinformationand trainingconsiderationsnecessarytoaccompanyanyswitchingapplication.Examplesof UK switches can be found in Appendix 2. TheEuropeanMedicinesAgency(EMA)hasalsoconsideredthepan-European classification for a number of medicines which could potentially be switched. Examples of recent EMA switches include orlistat and pantaprazole, indicating the EMAs confidence in self-medication. Following the switching of levonorgestrel by the IMB in February 2011,the IMB set up a ConsultativePanelontheLegalSupplyClassificationofMedicineswhoseaimisto advisetheIMBManagementCommittee.TheSwitch-OntoSelf-CareWorkingGroup welcomestheestablishmentofthispanelandlooksforwardtotheoutcomeofits deliberations.WebelievethatlocalIrishreclassificationinitiatives,ledbyapro-active policythatrecognisesthevalueofswitchingtopopulationhealth,shouldplayamajor part in future Irish switching decisions. Industryandpharmacistshavecollaboratedtoproduceeducationaltoolsandprotocols following such switches to assist pharmacists in supplying these medicines. The Working Groupwouldadvisethat3monthsnoticebegivenforfutureswitchestofacilitatethe developmentandrolloutoftheseprotocolsandeducationprogrammestocommunity pharmacists.

13 Switch on to Self-Care booklet, IPHA, 2009, page 6. In early 2001, the Medicines Control Agency, now the Medicines and HealthcareproductsRegulatoryAgency(MHRA),broughttogetherallrelevantstakeholdersincludingtheProprietary Association of Great Britain, the Association of the British Pharmaceutical Industry, the Royal Pharmaceutical Society of Great Britain, the Royal College of General Practitioners and patient associations. As a result, the medicines outlined in Annex 2 are available without prescription in the United Kingdom while they remain prescription-only in Ireland. Self-Care First- A Self-Care Framework for Ireland 2012 7 Self-Care First A Self-Care Framework for Ireland 20129 5. CONCLUSION The proposed Self-Care Framework requires a change in the value attributed to self-care by allstakeholders,particularlybythelegislator,theregulator,healthcareprofessionalsand patients themselves. The current resource constraints constitute an opportunity to reorganise the way healthcare isprovidedinIreland,byencouragingpatientstotakebettercareoftheirhealth(through illness prevention and wellness) and by ensuring that patients access treatment at the lowest appropriate level rather than, as too often happens, seeking treatment at a higher level than required. 6. ANNEX 1: MEMBERS OF THE SWITCH-ON TO SELF-CARE WORKING GROUP Members of the Switch-On to Self-Care Working Group are: DrColinBradley,MemberoftheIrishCollegeofGeneralPractitionersandHeadofthe Department of General Practice at University College Cork DrMartinHenman,SeniorLecturerinPharmacyPractice,SchoolofPharmacyand Pharmaceutical Sciences, Trinity College Dublin Ms Pamela Logan, Director of Pharmacy Services, Irish Pharmacy Union MrNiallOShea,HeadofRegulatory&ExternalAffairs,GlaxoSmithKlineConsumer Healthcare Dr. David Hall, Commercial Director Ireland, Johnson and Johnson (Ireland) Mr. Sergio Schuler, Country Division Head, BCC Ireland, Bayer Ms Michelle Anderson, HSE Pharmacist, Corporate Pharmaceutical Unit, Health Service Executive [Observer status only] 8 Self-Care First- A Self-Care Framework for Ireland 2012 Self-Care First A Self-Care Framework for Ireland 201210 7. ANNEX2:PRESCRIPTION-ONLYTOPHARMACY-ONLYMEDICINES SWITCHES IN THE UK, 2002 TO 2012 MedicineIndication Alclometasone DipropionateEczema and dermatitisAspirin 75mgPrevention of heart attack and stroke Azelastine HydrochlorideAllergic rhinitis AzithromycinTreatment of chlamydia ChloramphenicolAcute bacterial conjunctivitis Clobetasone ButyrateEczema and dermatitis Diclofenac Anti-inflammatory EconazoleFungal skin infections FelbinacTopical anti-inflammatory FluconazoleOral treatment of vaginal candidiasis Fluticasone PropionateAllergic rhinitis FlunisolideAllergic rhinitis FlurbiprofenAnti-inflammatory throat lozenges GriseofulvinAnti-fungal foot spray Hydroxyzine HydrochloridePruritus HyoscineGastro-intestinalspasm LidocaineLocal anaesthetic Lodoxamide TrometamolAllergic conjunctivitis Mebeverine HydrochlorideGastro-intestinal spasm NaproxenDysmenorrhoea OmeprazoleAcid reflux Prochlorperazine MaleateNausea and vomiting in migraine SimvastatinTo reduce the risk of a first coronary event Sumatriptan SuccinateAcute relief of migraine attacks Tamsulosin Hydrochloride Benign prostatic hyperplasia TerbinafineAnti-fungal Tranexamic acidDysmenorrhoea Self-Care First- A Self-Care Framework for Ireland 2012 9