medicines policy 2020 - valtioneuvosto
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Helsinki 2011
MEDICINES POLICY 2020Towards efficient, safe, rational and cost-effective use of medicines
Publications of the Ministry of Social Affairs and Health 2011:10eng
MINISTRY OF SOCIAL AFFAIRS AND HEALTH
MEDICINES POLICY 2020
Towards efficient, safe, rational and cost-effective use of medicines
Publications of the Ministry of Social Affairs and Health 2011:10eng
ISBN 978-952-00-3165-7 (PDF)
ISSN-L 1236-2050
ISSN 1797-9854 (verkkojulkaisu)
URN:ISBN: 978-952-00-3165-7
http://urn.fi/URN:ISBN: 978-952-00-3165-7
www.stm.fi/julkaisut
Publisher : Ministry of Social Affairs and Health
Layout and printed by: Helsinki University Press, Helsinki 2011
SUMMARY
ThedocumentMedicinesPolicy2020reportsonthejointobjectivesofthesocialwelfareandhealthcareauthoritiesandstakeholdersinthefieldofmedicinesbytheyear2020.
1. Pharmaceutical service is a part of the social welfare and healthcare service system
Socialwelfareandhealthcareservicesmustbeincreasinglydevelopedtorespondtotheneedsoftheclients.Thechiefobjectiveofpharmaceuticalservice is to enable an efficient, safe, rational and cost-effectivepharmacotherapyforallthoseinneedofit.Interprofessionalcooperationandagreeingonjointpoliciesandgoalsregionallyandlocallyareprerequisitesforsecuringsystematicandsustainedoperations.Theutilisationofinformationsystemsavailableinsocialwelfareandhealthcareandtheircompatibilityshouldbeenhanced.Thegoalistodeliverallprescriptionselectronically.
2. Pharmaceutical service is of high quality, eff icient and cost- effective
Agoodavailabilityandaprofessionallyoperatingdistributionofmedicinalproductsmustbesecuredforcitizensunderallcircumstances.Thefundingsystemsmustunderpinsuchpharmacotherapyorservicesthatpromotethemaintenanceofthepopulation’sworkingandfunctionalcapacityaswellasindependentcoping.Theexpensesofmedicinalproductsmustbeevaluatedasapartofthetotalhealthcareexpenditures.Themedicinereimbursementsystem must support cost-effective treatments in order to curb theexpenditure.Theknow-howandpracticesoftheadvisorycommitteesonmedicines,hospitalpharmaciesandmedicinedispensariesinestablishingabasicformularyofmedicinalproducts,inpurchasesofmedicinalproductsandcompetitivetenderingneedstobedeveloped.
3. Rational pharmacotherapy and good medication safety enhance the wellbeing of the population, improve public health and decrease the healthcare expenditures
Theclients’ownroleandresponsibilityinhealthcareandmedicaltreatmentshouldbeincreasedinparticularinthetreatmentoflong-termdiseasesandsymptomsthattheycaneasilytreatthemselves.Successfulpharmacotherapyshouldbe improvedbyguidanceprovidedfor instancebypharmacists,dispensersandotherhealthcareprofessionals.TreatmentsfollowingthenationalCurrentCareGuidelinesmustbepromoted.Theaccessofhealthcareprofessionals,thepopulationandusersofmedicinestoreliableandevidence-basedinformationonmedicinalproductsmustbeensured.Theconsumers’andpatients’criticalliteracyinhealthinformationshouldbepromoted.
Key words: health care, health policy, health services, medicinal products, pharmaceutical service, pharmacotherapy, social services
4. Pharmaceutical research enhances health, wellbeing and employment
Successful pharmaceutical research enhances the population’s health,wellbeingandemployment,andthereforeinnovationsandtheirutilisationinthefieldofmedicinesoughttobepromoted.Theassessmentofthetherapeuticandeconomicvalueofmedicinalproductsmustbeincreased,andoptimallyuniformmethodsbasedonsimilarcriteriaandevidenceshouldbeusedinthiswork.Themethodsofassessingthetherapeuticandeconomicvaluemustbeutilisedtoagreaterextentinthedecision-makingconcerningthereimbursementstatusofmedicinalproducts.
5. Veterinary pharmaceutical service safeguards public health and promotes the wellbeing of people and animals
Anappropriateuseofveterinarymedicinalproductssecuresthesafetyofconsumers.Theregionalandnationalaccesstoveterinarymedicinalproductsmustbesecured,andtheir importsanddistributionmustbesafe.Themonitoringoftheconsumptionanduseofantimicrobialagentsshouldbedeveloped,andadequatesystemsmustbecreatedfortheuse,dispensingandprescribingofveterinarymedicinalproducts.
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PREFACE
Medicinespolicyisapartofthesocialwelfareandhealthpolicy.ThepresentMedicinesPolicy2020documentincludesthemedicinespolicyobjectivesforthecomingdecadeandsharpensthefocusofthesocialwelfareandhealthcarestrategy.
Themedicinespolicyoutlinehasbeendrawnincollaborationwiththestakeholdersofthepharmaceuticalbranch.Allphasesofthemedicinelifearehererepresented:fromresearchtopatients.
Theworkstartedinearly2010.ThesteeringandpreparatorygroupsaswellasvarioussubgroupselaboratedonthebestwaystoprovidetheFinnswithnecessarypharmacotherapies,alsointhefuture.
TheprocesstowardstheMedicinesPolicy2020documentwasverypo-sitiveandsuccessful.Sittingaroundonetable,theparticipantsweighedthestrengthsandweaknesses,threatsandpossibilitiesofthecurrentpharma-ceuticalsector,lookingformeanstofurtherimproveit.Inadditiontothejointoutlines,welearnedtocollaborateinamoreefficientway.
ThestrategyoftheMinistryofSocialAffairsandHealthwasunderprepa-rationatthesametime.Accordingtothenewstrategy,ourobjectiveisaso-ciallysustainablesocietywhereindividualsaretreatedequally,ensuringeachandeveryone’sinclusionandpromotingtheirhealthandfunctionalcapacity.Themedicinespolicysharestheseobjectives.Successfulpharmacotherapyisanimportanttoolinthetreatmentofdiseases,andgoodpharmaceuticalservicesmustbeequallyavailabletoall.
HavingnowcompletedtheMedicinesPolicy2020documentwearehappytocontinuetheco-operation.Theimplementationoftheoutlinesonanatio-nalandinternationallevelwillcallforgoodinteractionandopencommuni-cationbetweenthestakeholdersinthebranch.Thegovernmentprogrammesetstheframeworkfortheimplementationofthemedicinespolicybutthedocumentalsoincludesseveralobjectivesspecifictothebranch,bestimple-mentedinday-to-daypracticalwork.MedicinesPolicy2020isapositivestarttoasustainableandsolidpracticalco-operation.
KariVälimäkiPermanentSecretary
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CONTENTS
Preface ...............................................................................................................5
Foreword ..........................................................................................................9
1 Pharmaceutical service constitutes part of social welfare and healthcare service systems .....................................................................101.1 Pharmaceutical service operations are customer-oriented ................12
2 Pharmaceutical service is of high quality, efficient and cost- effective ......................................................................................................152.1 Ensure access to medicines and functioning of pharmaceutical
service in all conditions ..............................................................................152.2 Financing systems promote materialisation of economically most
advantageous pharmacotherapies and efficient utilisation of limited resources .......................................................................................................17
2.3 Medicine reimbursement system is unambiguous and decision- making system transparent ........................................................................18
3 Rational pharmacotherapy and good medication safety improve people’s wellbeing and public health, decreasing healthcare expenditure ...............................................................................................203.1 Medicine users are encouraged to assume responsibility for
treatment of their diseases ....................................................................... 203.2 Increase production of reliable information on rational
pharmacotherapies disseminated to healthcare professionals and medicine users ..............................................................................................21
3.3 Promote efficient, safe, rational and cost-effective use and prescription of medicines .......................................................................... 23
3.4 Improved medication safety promotes public health .......................... 25
4 Pharmaceutical research improves health, wellbeing and employment rates ....................................................................................274.1 Promote generation and exploitation of pharmaceutical
innovations .................................................................................................. 274.2 Promote rational pharmacotherapies through evaluations of
therapeutic and economic value of medicines ...................................... 29
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5 Veterinary service safeguards public health and promotes wellbeing of humans and animals ..........................................................315.1 Rational use of veterinary medicines guarantees consumer safety ...31
6 Follow-up plan focusing on implementation of proposed medicines policy 2020 actions ...............................................................346.1 Practical actions and evaluation of impacts ........................................... 346.2 Timetable ...................................................................................................... 35
Appendix 1 ......................................................................................................36Appendix 2 ......................................................................................................37Appendix 3 ......................................................................................................38Appendix 4 ......................................................................................................39Appendix 5 ......................................................................................................40
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FOREWORD
Themainobjectiveofthepharmaceuticalserviceistoprovideefficient,safe,rationalandcost-effectivepharmacotherapiestothosewhoneedthem.Theobjectivecanbereachedbydevelopingthecurrentsystemtowardsabettermatchwiththecustomerneeds.
MedicinesPolicy2020isadocumentreportingonthejointmedicinepolicyperspectivesofthesocialwelfareandhealthcareauthoritiesandthebranchstakeholdersforthecomingdecade.Thepolicyoutlinesarecrystal-lisedintheformoffivemainobjectives:
The main medicines policy objectives for 2020 defined by the working group:
1.Thepharmaceuticalserviceconstitutesapartofthesocialwelfareandhealthcareservicesystem.
2.Thepharmaceuticalserviceisofhighquality,efficientandcost-effective.3.Rationalpharmacotherapiesandgoodmedicationsafetypromotepeople’s
wellbeingandpublichealth,decreasingthehealthcareexpenditure.4.Pharmaceuticalresearchhasapositiveimpactonhealth,wellbeingand
employment.5.Veterinarypharmaceuticalservicessafeguardpublichealthandpromote
thewellbeingofhumansandanimals.
TheMedicinesPolicy2020documentpresentstheagreedactionsfortheattainmentofthemainobjectivesaswellasthepartiesthatareresponsibleandco-operatefortheirimplementation.Theadvantagespursuedthroughtheactionsarealsopresented.Thefinalpartofthedocumentdefinesafollow-upplanfortheattainmentoftheobjectivesandmeasurementoftheoutcomes.
TheAppendicestothedocumentcontainnumericaldataaboutthephar-maceuticalbranchaswellasdefinitionsoftermsandabbreviationsusedandtheco-operationpartiesinvolved.
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1 PHARMACEUTICAL SERVICE CONSTITUTES PART OF SOCIAL WELFARE AND HEALTHCARE SERVICE SYSTEMS
Medicinesandvaccinesplayanessentialroleforhealthcareandmedicalcare.Awellworkingsocialwelfareandhealthcareservicesystembenefitsfrompharmaceuticalservices,andviceversa.Well-functioningservicesandsatisfiedcustomersandpatientsaresharedobjectives.
Thecorevaluesofmedicinespolicyareresponsibility,effectiveness,quali-ty,equalityandjusticeaswellaseconomydefinedascost-effectiveness.Therespectofhumandignityandcustomer-orientationaimatthepromotionofpeople’shealthandtheirworkingandfunctionalcapacityunderallcircum-stances.Otheraimsincludesustainabledevelopment,transparentsystemsandsystematicoperationaccordingtoplan.
Thelogisticchaininthepharmaceuticalservicesincludesthepharma-ceuticalindustry,pharmaceuticalwholesalers,outpatientandhospitalphar-maciesandmedicinedispensaries.Thepharmaceuticalindustryisinchargeofpharmaceuticalresearchanddevelopmentaswellasproduction.Universities,universityhospitalsandvariousresearchinstitutes,alsothoserunbytheauthorities,engageinresearchfocusedonmedicinesandthepharmaceuti-calservice.Thepharmaceuticalindustryandwholesalersareresponsibleforpharmaceuticalimportswhilethewholesalersareinchargeofthestockinganddistributionofmedicines.Theretaildistributionofmedicinestakespla-cethroughoutpatientandhospitalpharmaciesandmedicinedispensariesand,toalimitedextent,throughretailgrocerytradeinthecaseofnicoti-nereplacementtherapyproducts.TheInstituteforHealthandWelfareaswellashospitalpharmaciesandmedicinedispensariesareinchargeofthedistributionofvaccinesincludedinthegeneralvaccinationprogramme.Themedicinesreimbursementsystemplaysacentralrolefortheoperationofthepharmaceuticalservice.
TheprovisionsrelatedtomedicinesandvaccinecontrolareharmonisedwiththeEUregulations,andfromthecontrolfunctionperspective,FinlandconstitutesapartofthecontrolnetworkoftheEUMemberStates.Thede-cisionsinfluencingtheFinnishpharmaceuticalserviceareincreasinglymadeontheinternationalarenas.TheEUmedicineslegislation(MedicinesDirec-tive1andRegulation2)regulatethepharmaceuticalmarketingauthorisations,distributionandcontrolatthecommunitylevel.Pharmaceuticaldistribution,medicinereimbursementsystemsandvaccineprogrammesfallwithinthenationalcompetence.Themainprovisionsonthepharmaceuticalserviceare
1 Directive 2001/83/EC of the European Parliament and of the Council
2 Regulation (EC) No 726/2004 of the European Parliament and of the Council
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includedintheMedicinesAct3andtheprovisionslaiddownonthebasisofit,whilethoseonthetasksofpharmaceuticalserviceoperatorsareincludedintheActonHealthCareProfessionals.4ThemedicinesreimbursementsystemisdefinedintheHealthInsuranceAct5.TheActontheStatusandRightsofPatients6containstherespectivehealthcare-relatedprovisionswhiletheonesfocusingonthesocialwelfareclientsarecontainedintheActontheStatusandRightsofSocialWelfareClients7.Thereisalsospecificlegislationonmedicationofanimals.
Administration and supervision of the social welfare and healthcare services
The Ministry of Social Affairs and Health is responsible for theadministrative development of the pharmaceutical service, thepreparationof themedicines legislation and themedicinespolicy.TheFinnishMedicinesAgencyFimeaisinchargeoftheauthorisationandcontrolfunctionsrelatedtothepharmaceuticalbranchaswellasforthemedicinesafetyissues.Moreover,Fimeaengagesinresearchfocusingonpharmaceutical-epidemiological,medicinespolicy andpharmacoeconomicalaspects,forwardingpharmaceuticalinformationto improve the effectiveness of the pharmaceutical service andpharmacotherapies.ThePharmaceuticalsPricingBoardistheresponsibleauthorityforthedecisionsonmedicinepricesandreimbursability.TheNationalSupervisoryAuthorityforWelfareandHealthValviraguidesandsupervisestheoperationofhealthcareorganisationsandprofessionals.Italsocoverscertainfunctionsrelatedtotheguidanceandsupervisionofsocialwelfareservices.TheSocialInsuranceInstitutionisinchargeofthebasicsocialsecurityoftheresidentsofFinland,includingmedicinereimbursements. Moreover, the Social Insurance Institution doesresearchfocusedonthemedicinesreimbursementsystemandtheuseofmedicines.TheNationalInstituteforHealthandWelfareTHLisanexpertinstitutionundertheadministrationoftheMinistryofSocialAffairsandHealth.TheInstitute’sresponsibilitiesincludethevaccinationprogramme.
3 Medicines Act 395/1987
4 Act on Health Care Professionals (559/1994)
5 Health Insurance Act 1224/2004
6 Act on the Status and Rights of Patients 785/1992
7 Act on the Status and Rights of Social Welfare Clients 812/2000
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1.1 PHARMACEUTICAL SERVICE OPERATIONS ARE CUSTOMER-ORIENTED
Thepharmaceuticalservicemustbedevelopedtomeetthecustomerneeds.Customerorientationalsomeansthatthepatientsareencouragedtotakeresponsibilityfortheirowncare.
Thenationallyagreedcarerecommendations,suchastheCurrentCareGuidelines,promotetheproperuseofmedicines.Theregionalagreementprocedureencompassesthemunicipalhealthcareorganisationplans,definedintheHealthCareAct,andtheplansarebasedontheregionalpopulation’shealthfollow-updataandserviceneeds.Theyalsoincludeagreementsonmunicipalco-operation,objectivesandresponsiblebodiesforthepromotionofhealthandwellbeingaswellastheorganisationofhealthcareservicesbetweenthevariousactors.Fromtheperspectiveofpharmaceuticalservice,itisparticularlyimportanttoagreeonthelocalpracticalactionstopromoteco-operation.
Interprofessionalco-operationbetweenvarioushealthcareprofessionalslaysthefoundationsforasmoothclient-orientedservicewholethattranscendsanyadministrativeandorganisationalboundaries.Thepatients’well-func-tioningcarepathwaysandsuccessfulmedicationcanbepromotedthroughthedevelopmentofinterprofessionalandinter-organisationalco-operationmodels.
Ahighlevelofbasictrainingofthehealthcareprofessionalsthatmeetstheneedsofpracticalworklifeaswellastheirsystematicfurthereducationaretoolsforkeepingupthelevelofcompetenceneededinhealthcare.Wemustensurethatthelevelofprofessionalcompetenceremainshighinthefuture.
Well-workinginformationsystems–includingthee-prescription–willfacilitatetheeffectivenessandoverallcost-effectivenessanalyses,therebyimprovingpatientsafety.Patientrecords,includingthemedicationdata,arealreadynowmostlyindigitalform.However,theproblemsinthetransferofdatabetweenpatientrecordsystemsaswellastheinternalusabilityproblemsinthesystemsweakentheirfeasibilitypotential.Compatibleinformationsystemswouldsupportthecontinuityofcareandcomprehensivemonitoringofitsoutcomes.Asaconsequence,thecarepathwaywouldnotbeinterruptedwhenthepatientmovesfromprimaryhealthcaretospecialisedmedicalcare,orasocialwelfareclientmovesfromaninstitutiontothenon-institutionalcaresector.Comprehensiverecordingofmedicationdataisaprerequisiteforthemonitoringofcareoutcomesonthenational,regionalandlocallevels.
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Actions
1.Developsmooth,client-orientedandcost-effectiveoperationalmodelsinsocialwelfareandhealthcarebothregionallyandlocallyinviewoftheimplementationandmonitoringofpharmacotherapies.
Responsibleparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare
Co-operationparties:Fimea,Valvira,Social Insurance Institution,RegionalStateAdministrativeAgencies,professionalorganisations,FinnishMedicalSocietyDuodecim,municipalities,hospitaldistricts,socialwelfareandhealthcareunits,hospitalpharmacies,medicinedispensaries,pharmacies,pharmaceutical industry,pharmaceuticalwholesalers.
2.Agreeonthejointpharmaceuticalserviceobjectivestoensuresystematicandsustainedoperations.
Responsibleparties:MinistryofSocialAffairsandHealth,NationalInstitute forHealthandWelfare,Fimea,Valvira,Social InsuranceInstitution
Co-operationparties:Allpharmaceuticalbranchstakeholders
3.Strengtheninterprofessionaloperationalmodelsintheimplementationofthepatient’spharmacotherapyandconsultation,bothinoutpatientandinpatientcare.
Responsibleparties:Fimea,NationalInstituteforHealthandWelfare
Co-operationparties:Socialwelfareandhealthcareunits,pharmacies,hospitalpharmacies,medicinedispensaries,AssociationofFinnishPharmacies,UniversityPharmacy,professionalorganisations,universities
4.Strengthenco-operationbetweentheMinistryofSocialAffairsandHealthontheonehandandtheMinistryofEducationandCultureontheotherhandtodevelopbasic,continuingandon-siteeducation.Moreefficientco-operationintrainingbetweentheauthoritiesandthetrainingunits.
Responsibleparties:MinistryofSocialAffairsandHealth,MinistryofEducationandCulture
Co-operationparties:Fimea,universities,universitiesofappliedsciences,secondarylevelvocationalinstitutes
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5.Developinformationsystemsusedinsocialwelfareandhealthcare,relatedtothepharmaceuticalservice,improvingtheirmutualcompatibilityandusability.
Responsibleparties:MinistryofSocialAffairs andHealth,SocialInsuranceInstitution
Co-operationparties:Fimea,NationalInstituteforHealthandWelfare,hospitaldistricts,informationsystemproviders
6.Introducee-prescriptions,withtheaimofallprescriptionsissuedindigitalform.
Responsibleparties:MinistryofSocialAffairsandHealth,Fimea,SocialInsuranceInstitution
Co-operationparties:AssociationofFinnishPharmacies,UniversityPharmacy,professionalorganisations,socialwelfareandhealthcareunits,pharmacies,hospitalpharmacies,medicinedispensaries
Aims of actions:
� improved operational models, planned action and improved co-operationmakestheentirehealthcaresystemmoreefficientandmoreclient-oriented
� thepharmacotherapyobjectivesareincreasinglyattained� increased co-operation in the training of healthcare professionals
improvesstaffcompetence� bettermonitoringoftreatmentsimprovesthepharmacotherapyoutcomes� theexchangeofinformationcanbeimprovedthroughwell-functioning
electronicsystems
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2 PHARMACEUTICAL SERVICE IS OF HIGH QUALITY, EFFICIENT AND COST-EFFECTIVE
2.1 ENSURE ACCESS TO MEDICINES AND FUNCTIONING OF PHARMACEUTICAL SERVICE IN ALL CONDITIONS
Theaccess tomedicinesandaprofessionallyoperatingpharmaceuticaldistributionsystemmustbeguaranteedtothepopulation.Themedicinesselectionmustensuretherationalandefficientpharmacotherapyofpatients.ThechallengeistowarranttheavailabilityofnovelmedicinesandthoserarelyneededbyasmallgroupofpatientsaswellastoguaranteetheexistenceofacomprehensivedistributionnetworkthroughoutFinland,theremoteareasincluded.
Theaccesstoandavailabilityofmedicinesdependsonthefunctioningofthepharmaceuticalindustry,wholesalers,pharmacies,hospitalpharmaciesandmedicinedispensarysystemsaswellasonthepredictabilityofthefactorsinfluencingthepharmaceuticalmarket.
Fromtheperspectiveofthecurrentdistributionsystem,theessentialfactorsinfluencingtheaccesstomedicinesincludethecomprehensivenessofthepharmacynetworkandthequalityofitsoperationaswellasthecoverageanddeliverytimesofthewholesaleroperations.Thepharmaciesmustalsoparticipateinthemonitoringofpatientcare,andtheiroperationswillbeinc-reasinglyconcentratedonhealth-promotingpharmaceuticalservicefunctions.
Hospitalpharmaciesandmedicinedispensariesoperateasapartofthepublichealthcaresystem.Cost-effectivenessappraisalsmustbeperformedasanintegralelementofthepharmaceuticalservice.
Importedmedicinesplayanimportantroleinpharmaceuticalservice,andthereforetheaccesstomedicinesunderemergencycircumstancesmustbeensuredthroughtheobligatoryandemergencystockpilingarrangementsformedicinesandvaccines,implementedbythepharmaceuticalindustry,hospitals,healthcarecentres,theState,theNationalInstituteforHealthandWelfareandtheNationalEmergencySupplyAgencyaswellasbymaintainingtheconditionsfornationalpharmaceuticalproduction.
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Actions
1.Developthepharmaceuticaldistributionandstockpilingsystemstoensurethatpatientshaverational,safeandeffectivepharmacotherapiesonanation-widescale.
Responsibleparties:MinistryofSocialAffairsandHealth,Fimea
Co-operationparties:AssociationofFinnishPharmacies,UniversityPharmacy, pharmaceutical wholesalers, pharmaceutical industry,pharmacies,hospitalpharmacies,medicinedispensaries,professionalorganisations
2.Developtheobligatoryandemergencystockpilingfunctionsinacost-effectivemannertoguaranteethesecurityofsupply.
Responsibleparties:MinistryofSocialAffairsandHealth,Fimea,NationalEmergencySupplyAgency
Co-operation parties: National Institute for Health and Welfare,hospitalpharmacies,medicinedispensaries,pharmaceuticalwholesalers,pharmaceuticalindustry
3.Enhancethecompetenceandpracticesofpharmaceuticaladvisorycommitteesandhospitalpharmaciesandmedicinedispensaries inrelationtothebasicmedicineformulary,medicineprocurementsandcompetitivebidding.
Responsible parties: Hospital districts, municipalities, hospitalpharmacies,pharmaceuticalindustry
Co-operationparties:MinistryofSocialAffairsandHealth,Fimea
Aims of actions:
� patientsreceivethenecessarymedicationunderallcircumstances� thepracticesofoutpatientandinstitutionalpharmaceuticalservicewill
improvethroughdevelopedprocesses� ensured competitive conditions will maintain a well-functioning
pharmaceuticalservice
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2.2 FINANCING SYSTEMS PROMOTE MATERIALISATION OF ECONOMICALLY MOST ADVANTAGEOUS PHARMACOTHERAPIES AND EFFICIENT UTILISATION OF LIMITED RESOURCES
Financingsystemsalsoinfluencethechoiceofpharmacotherapies.Today,pharmacotherapiesaremainlyfundedthroughtwoseparatechannels.Themedicinesusedinpublichealthcareareincludedinthetreatmentcostspaidbythepatient'smunicipalityofresidenceorthejointmunicipalboard.Thepublichealthcaresectoralsopaysforthevaccinesincludedinthenationalvaccinationprogramme.Theoutpatientmedicinesprescribedbyadoctorarepartlyreimbursedbythenationalhealthinsurancewhilethepatientspaythewholepriceoftheself-caremedicinestheybuywithoutaprescription.Thecurrenttwo-tierfinancingsystemmayinsomecasesleadtopartialoptimisationofthetreatment.
Thefinancingsystemsmustsupportpharmacotherapiesandserviceswhichpromotethemaintenanceofworkingandfunctionalcapacityandin-dependentcopingofthepopulation.Thefinancingsystemsmustbeevaluatedanddevelopedsothattheyallowforarationalandeffectivepharmacotherapyforthepatients.Itisindispensabletousetheresourcesefficientlytoensuretheavailabilityofservicesbutthisobjectivemustnotconstituteanyriskforpatientormedicinesafety.
In2008,themedicinesandmedicinalconsumergoodsaccountedforabout14%oftheoverallhealthcareexpenditure(Appendix2).In2009,thetotalsalesofmedicinesatretailprices,taxesincluded,wereabout2.6billioneuro,1.3%lessthanin2008(Appendix3).Thehealthinsurancereimbursementsonmedicineswereabout1.2billioneuroin2009(Appendix3).
Medicinecostsmustbeseenasapartoftheoverallhealthcareexpendi-ture.Accordingtothereport8bytheexpertgroupattheNationalInstituteforHealthandWelfarefocusingonthemulti-tierfinancingofsocialwelfareandhealthcareservices,therearenosolidargumentstoseparatethefinancingoftheoutpatientmedicinesfromtherestofthehealthcaresystem.Medicinefinancingresponsibilitycouldbeinthesame"basket"withtheotherformsoftreatmentandoperationinthehealthcaresystem.However,inthecontextofthecurrentmunicipalstructure,itisnotrationaltodecentralisepharma-cotherapyfinancingtothemunicipallevel.Decentralisationwouldrequireconsiderablystrongerorganisationstoshoulderthefinancingresponsibility.Anypossiblenewsystemshouldoperateonthebasisofnationallyuniformmedicinereimbursementcriteria.
8 Expert group of the National Institute for Health and Welfare: Sosiaali- ja terveydenhuollon monikanavaisen rahoituksen edut, haitat ja kehittämistarpeet, 17.11.2010
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Actions
1.Considerneedtoreformthefinancingofthepharmaceuticalservice(outpatientandinstitutionalcare)intheoverallcontextofthesocialwelfareandhealthcarereform.
Responsibleparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare
Co-operationparties:Fimea,Social InsuranceInstitution,hospitaldistricts,municipalities,pharmaceuticalindustry
Aims of actions:
� therearelessfinancing-relatedproblems,suchaspartialoptimisation� medicalgroundsareemphasisedinthechoiceofpatients’therapyoptions
2.3 MEDICINE REIMBURSEMENT SYSTEM IS UNAMBIGUOUS AND DECISION-MAKING SYSTEM TRANSPARENT
Thecoreobjectiveofpharmaceuticalserviceistoguaranteehighquality,reasonablepricesandcost-effectivepharmacotherapies.Tokeepcostsincontrol,themedicinesreimbursementsystemmustpromotecost-effectivetherapies.Theshareofpatientandcustomerco-paymentsofthehealthcareexpendituremustremainreasonable.
Thecurrentmedicinereimbursementsystemiscomplicatedandcausesmuchadministrativework.Thefutureindividualpharmacotherapieswillmakethesystemevenmorecomplex.Thereimbursementsystemmustbesimplified,andthenewITpossibilitiesmustbeexploitedtoanincreasingextent.Theimplementationofthesystemmustbeinproportiontothetar-getssetoradvantagesgained.
Theregulationofmedicinereimbursementsandpricesisextensivelyusedbyvariouscountriesasonemeansofcontrollingthemedicineexpenditure.Awell-functioningregulationsystemensurestheavailabilityofreasonably-pricedandnecessarymedicines,andsupportsandpromotesthecompetitiononthepharmaceuticalmarket.
Significantcostsavingsaregeneratedwhenthepharmaceuticalmarketcompetitionanduseofgenericsarepromoted.Anunambiguousandtranspa-rentdecision-makingsystemhelpstoimprovethefunctioningofthereimbur-sementandpriceregulationsystem.Theopennessandtransparencycriteriaapplytoboththeauthoritiesandthecompanies.
Thereferencepricesystemhasbeenanefficientmeanstocurbthecostsofmedicinesthathavebeenonthemarketforalongtimeaswellastopro-motepricecompetition.Thesystemmustbefurtherdeveloped,takingtheexperiencegainedbyvariousstakeholdersandpatientsintoconsideration.
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Actions
1.Ensurethereasonablenessoftheco-paymentburdencarriedbythepatientsinneedofmedicinesthroughajointpaymentceilingforthesocialwelfareandhealthcaresystems.
Responsibleparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution
Co-operationparties:Municipalities
2.Developthedecision-makingprocessfocusingonreimbursementandpriceregulation:- byimplementinganelectronicapplicationprocedureandutilising
otherweb-basedservices- byanalysingtheneedfornewoperationalmodelsandproceduresin
priceregulation- byanalysingtheoperationalmodelsandevaluationcriteriaofthe
pharmacotherapypriceregulation,inuseforalongtime
Responsibleparties:MinistryofSocialAffairsandHealth
Co-operationparties:Fimea,SocialInsuranceInstitution,pharmaceuticalindustry
3.Examinethepossibilitiestodecreasetheadministrativeworkcausedbythemedicinesreimbursementsystem.
Responsibleparties:MinistryofSocialAffairsandHealth
Co-operationparties:SocialInsuranceInstitution,patientorganisations,pharmacies
4.Developthereferencepricesystemonthebasisoftheexperiencesgainedtodate.
Responsibleparties:MinistryofSocialAffairsandHealth
Co-operationparties:Fimea,SocialInsuranceInstitution,pharmaceuticalbranchstakeholders
Aims of actions:
� theprocessesrelatedtomedicinereimbursementsandpriceregulationimprove
� thetransparencythroughouttheprocessincreases� developeddecision-makingprocessesreducetheadministrativework
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3 RATIONAL PHARMACOTHERAPY AND GOOD MEDICATION SAFETY IMPROVE PEOPLE’S WELLBEING AND PUBLIC HEALTH, DECREASING HEALTHCARE EXPENDITURE
3.1 MEDICINE USERS ARE ENCOURAGED TO ASSUME RESPONSIBILITY FOR TREATMENT OF THEIR DISEASES
Thepatients’ andcustomers’ rolemustbeenhanced,especially in thetreatmentofchronicdiseasesandeasilymanageablesymptoms.Thepatientsortheirrepresentativesmustbeinvolvedandagreeontheobjectivesandimplementationofthetherapy.Thetaskofpharmaceuticalserviceistosupporttheresponsibilityandinvolvementofthemedicineuser inthepharmacotherapy.Moreover,theadvicegivenbythehealthcareprofessionals,pharmacistsanddispensersinparticular,isinstrumentalfortheproperuseofself-caremedicines.Promotionofhealthandpreventionofdiseasesarealsoamongthepharmaceuticalserviceobjectives.
Pharmacotherapiesdonotalwaysmaterialiseasinstructed.Irrationalordownrighterroneoususeofmedicinesmayweakentheoutcomeofthephar-macotherapy,causesignificantadversehealtheffectsandincreasetheuseandcostofhealthcareservices.Theattainmentofpharmacotherapyobjectivescanbepromoted,forexample,byusingtoolssuchasthepatient-specificmedicationplans,medicinecards,comprehensivemedicationreviews(CMR)ordosedispensing.
Actions
1.Supportthepatientsintheattainmentoftherapyobjectives.
Responsibleparties:Socialwelfareandhealthcareunits,pharmacies
Co-operationparties:Patients,municipalities,patientorganisations,SocialInsuranceInstitution
2.Promoteandenhancewaystoimprovethesuccessofpharmacotherapies.
Responsibleparties:Socialwelfareandhealthcareunits,pharmacies,hospitalpharmacies,patients
Co-operationparties:Municipalities,professionalorganisations,MinistryofSocialAffairsandHealth,Fimea,NationalInstituteforHealthand
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Welfare,Valvira,SocialInsuranceInstitution,patientorganisations,pharmaceuticalindustry
3.Promotethegoodoutcomeofself-careandself-managementthroughtheadviceprovidedbypharmacists,dispensersandotherhealthcareprofessionals.
Responsibleparties:AssociationofFinnishPharmacies,UniversityPharmacy,pharmacies
Co-operationparties:Fimea,professionalorganisations
4.Developwaystointegratesafeself-careintothehealthcarewhole.
Responsibleparties:Fimea,NationalInstituteforHealthandWelfare,AssociationofFinnishPharmacies,UniversityPharmacy,pharmacies
Co-operation parties: Ministry of Social Affairs and Health,pharmaceuticalindustry,universities
Aims of actions:
� thepatients’treatmentadherenceimproves� systematicplanningimprovestreatmentsafety
3.2 INCREASE PRODUCTION OF RELIABLE INFORMATION ON RATIONAL PHARMACOTHERAPIES DISSEMINATED TO HEALTHCARE PROFESSIONALS AND MEDICINE USERS
Reliable and evidence-based pharmaceutical information accessible tohealthcareprofessionals,thegeneralpublicandmedicineusersconstitutesthebasisfortherationaluseofmedicines.Forhealthcareprofessionals,themostimportantchannelsofinformationonpharmacotherapiesaretheCurrentCareguidelinesaswellastheTerveysporttidatabaseandrelatedspecialiseddatabases,suchastheonesonmedicineinteractionsandprices.
Thegeneralpublicandthemedicineusersobtainpharmaceuticalinforma-tionfromdifferentsources.AbundantpharmaceuticalinformationisavailableintheInternetbutthequalityoftheinformationvaries.Theorganisationofpharmaceuticalinformationintheweb-basedpharmacyoperationsisanewchallenge.WemustalsorememberthatnoteverybodyusescomputersorothermeansofITC.
Properadviceontheuseofmedicinesisparticularlynecessarytothepatientswithlong-termpharmacotherapies.Thereisinsufficientreliable
22
pharmaceuticalinformation,withabalancedpresentationofthemedicineefficacyandsafetyvis-à-visotheravailabletherapyoptions.Thethreatsin-cludetheunnecessaryincreaseinmedicineuse,improperuseofthemedi-cinesandmedicalisation.
Actions
1.Strengthenbasic,furtherandcontinuingeducationonpharmacotherapies,information sources and patient advice functions targeted atpharmaceuticalandhealthcareprofessionals.
Responsibleparties:MinistryofEducationandCulture,universities,universitiesofappliedsciences,socialwelfareandhealthcareunits,trainingorganisations,secondarylevelvocationalinstitutions
Co-operationparties:MinistryofSocialAffairsandHealth,Fimea,professionalorganisations,pharmacies,hospitalpharmacies,medicinedispensaries,professionalorganisations
2.Supportmeasurestoprovidesocialwelfare,healthcareandpharmaceuticalpointsofoperationandthoseinvolvedinthepracticalpharmacotherapyofpatientswithproper,necessaryandupdatedpharmaceuticalinformationsourcesandtoensurethatthereiscompetencetousethesesources.
Responsibleparties:Socialwelfareandhealthcareunits,AssociationofFinnishPharmacies,UniversityPharmacy,Duodecim,pharmacies,hospitalpharmacies,medicinedispensaries
Co-operationparties:MinistryofSocialAffairsandHealth,Fimea,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution,universities,universitiesofappliedsciences,professionalorganisations,secondarylevelvocationalinstitutes
3.Ensurethathealthcareprofessionals,thegeneralpublicandmedicineusers have access to reliable and evidence-based pharmaceuticalinformation.
Responsibleparty:Fimea
Co-operationparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution,universities,universitiesofappliedsciences,AssociationofFinnishPharmacies,UniversityPharmacy,socialwelfareandhealthcareunits,pharmacies,hospitalpharmacies,medicinedispensaries,Duodecim,professionalorganisations,secondarylevelvocationalinstitutions,pharmaceuticalindustry,patientorganisations
23
4.Strengthennationalandinternationalresearchanddevelopmentgearedtowardstheproductionofpharmaceuticalinformationandservices,includingtheireffectivenessanalyses.
Responsibleparties:Fimea,universities,universitiesofappliedsciences
Co-operationparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution
5.Promotehealthinformationliteracyandcriticalanalysisskillsamongconsumersandpatients.
Responsibleparties:Universities, schools, adulteducationcentres,pharmacies
Co-operationparties:Fimea,socialwelfareandhealthcareunits
Aims of actions:
� healthcareprofessionalsandmedicineusershavebetterinformationonmedicinalproductsandtheiruse
� high-qualityandupdatedpharmaceuticalinformationmaydecreasethenumberofadverseinteractionsofmedicinesusedbyapatient
� co-operationpromotestheR&Donmedicines,andtheresearchoutcomecanbeusedtoimprovethequalityandeffectivenessofpharmaceuticalservices
� consumersandpatientsaremorecompetentinassessingthequalityoftheinformationobtained
3.3 PROMOTE EFFICIENT, SAFE, RATIONAL AND COST-EFFECTIVE USE AND PRESCRIPTION OF MEDICINES
Inadditiontotheprescriptionofmedicines,theotherfactorsinfluencingtheappropriatenessofpharmacotherapiesincludetheregularrecordingandassessmentoftherapyoutcomesandadverseeffects,aswellasthetransferoftheinformationbetweenthehealthcareunitsparticipatinginthecareofthepatient.Pharmacotherapiesshouldnotbeunnecessarilyusedinsteadofnon-medicinalformsoftherapy,suchashealthyhabitsandlifechanges.
Thetrainingforarationalprescriptionpractice,alreadystartedduringmedicalandpharmaceuticalstudies,shouldbefurtherdeveloped.Theob-jectiveistoapplyelectronictoolsandoperationalmodelsinmedicinepresc-riptions,showntobeusefulandcost-effectiveinpracticalworkorthroughotherevidence-basedmeans.
24
Inparticular,thepatientswithseveralsimultaneousmedicines,olderpersonsandotherspecialgroupsshouldhavemedicationplansandtheirpharmacotherapiesandtheirneedsshouldbeassessedonaregularbasis.Thesystemssupportingrationalprescriptionpracticesshouldbefurtherdevelo-pedandintroduced.
Actions
1.Considerpharmacotherapiesasanelementofthepatient'scomprehensivecare,rememberingtheappropriatepreventivemedicationsandnon-medicinalformsoftherapy.
Responsibleparties:Socialwelfareandhealthcareunits,pharmacies
Co-operationparties:SocialInsuranceInstitution,AssociationofFinnishPharmacies,UniversityPharmacy,professionalorganisations
2.Promotecomparativeevaluationsandfinancingofpharmacotherapiesandnon-medicinalformsoftherapy.
Responsibleparties:MinistryofSocialAffairsandHealth,Fimea,universities,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution
Co-operation parties: Social welfare and healthcare units, SocialInsuranceInstitution,pharmaceuticalindustry,researchfundingparties
3.PromotetherapiescomplyingwiththenationalCurrentCareguidelinesandguaranteetheresourcesforthedevelopmentandmaintenanceofthesupportsystems.
Responsibleparties:MinistryofSocialAffairsandHealth,Fimea,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution,Duodecim,healthcareunits,pharmacies,hospitalpharmacies
Co-operationparties:Professionalorganisations
4.Draft instructions on the contents and needs of comprehensivemedicationreviews(CMRs),definingthetasksofvariousprofessionalgroupsinthisprocess.
Responsibleparties:Fimea,NationalInstituteforHealthandWelfare
Co-operationparties:Duodecim,professionalorganisations,universities
25
5.Enhancethequalityofpharmacotherapiesbyincreasingtheexpertiseinclinicalpharmacologyandward-basedpharmacyactivitiesinhospitals,andbyutilisingunit-specificpharmacotherapyplans.
Responsibleparties:Healthcareunits,hospitalpharmacies,universities
Aims of actions:
� increaseintherapyeffectiveness,decreaseinthenumberofadversereactionscausedbymedicinesandimprovedtherapyoutcomes
� rationalpharmacotherapybringscostsavingsbydecreasingtheneedofhealthservicesandunnecessaryuseofmedicines
3.4 IMPROVED MEDICATION SAFETY PROMOTES PUBLIC HEALTH
Marketingauthorisationpracticesandsubsequentsupervisionarecentraltoolstoensuredrugsafety.TheseprocesseshavebeenharmonisedintheEuropeanUnion.InFinland,Fimeaisresponsibleforthisarea.
TheFinnishsystemworkswellasconcernsnotificationsofproductdefectsandsubsequentreactivesteps.ThedisseminationofcounterfeitmedicinesthroughinternationalInternet-basedtradeandillegalimportationconstitutenewthreatsinthisrespect.
Medicationsafetyreferstothesafetyinrelationtotheuseofmedici-nes.Thetermcoverstheprinciplesandoperationsofthesocialwelfareandhealthcareunits,gearedatensuringthesafetyofpharmacotherapiesandprotectingthepatientfromharm.Medicationsafetyisthreatenedbyfactorssuchasminimalparticipationbythepatientsintheirowncareandlackofpharmacotherapycoordination.Pharmacotherapyplansmadeatpointsofcare,reportsondangerousandadverseeffectsaswellassecurity-enhancingdatabasescanpromotemedicationsafety.
Actions
1.Strengthenanddevelopco-operationinthesupervision,monitoringandguidanceofdrugsafetyandmedicationsafetyissues.
Responsibleparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,Fimea,Valvira
Co-operationparties:Socialwelfareandhealthcareunits,pharmacies,hospitalpharmacies,medicinedispensaries,professionalorganisations,universities,pharmaceuticalindustry,pharmaceuticalwholesalers
26
2.Intensifynationalandinternationalco-operationbetweentheauthoritiestorecognisecounterfeitmedicinesandsolverelatedcrime
Responsibleparties:Fimea,Valvira,Customs,Police,pharmaceuticalindustry
Co-operationparties:MinistryofSocialAffairsandHealth,SocialInsuranceInstitution
3.Increasethegeneralpublic’sawarenessofcounterfeitmedicinesandrisksrelatedtomedicinesacquiredthroughtheInternet.
Responsibleparties:Fimea,NationalInstituteforHealthandWelfare,pharmaceuticalindustry,pharmacies,hospitalpharmacies
Co-operationparties:MinistryofSocialAffairsandHealth,healthcareunits,professionalorganisations,pharmaceuticalwholesalers,patientorganisations
4.Enhancemedicationsafetyresearchtorecogniseriskmedicinesandprocesses,alsousingtherelatedregisters.
Co-operationparties:Fimea,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution,universities,universityhospitals
Aims of actions:
� gooddrugsafetyandmedicationsafety� improvedpublicawarenessofcounterfeitmedicines
27
4 PHARMACEUTICAL RESEARCH IMPROVES HEALTH, WELLBEING AND EMPLOYMENT RATES
4.1 PROMOTE GENERATION AND EXPLOITATION OF PHARMACEUTICAL INNOVATIONS
Finlandisthevenueofhigh-qualitybiomedicalandclinicalresearch,andwehavesufficientcompetenceinindustrialpharmaceuticaldevelopmentandthustheconditionstogeneratenewpharmaceuticalinnovations.
Theareasrequiringdevelopmentincludethehealthcarepermitprocessesandcontractualnegotiationsrelatedtoresearchaswellastheopportunitiesgrantedtoresearcherstoparticipateinpharmaceuticaldevelopmentwork.Enhancedexploitationoftheoutcomesobtainedinbasicresearchwouldimprovepatentabilityopportunitiesandthusalsotheexploitationofphar-maceuticalinnovations.Morecomprehensiveandmoresustainedpharma-ceuticalriskfundingwouldpromotebusinessopportunities.Pharmaceuticaldevelopmentcreatesnewjobsnotonlyinthepharmaceuticalcompaniesbutalsoinrelatedservicecompaniesandinthehealthcaresector.
Pharmaceuticaldevelopmentcallsforactivenationalandinternationalco-operationandnetworkingamongtheexpertsofvariousdisciplinesaswellasamongthevariouspharmaceuticalstakeholders.Weshouldanticipatethechangesinhealthcareresultingfrompharmaceuticaldevelopment.TheparticipationinthepharmaceuticaldevelopmentontheEUlevelwillprovidetheresearchinstitutesandcompaniesexcellentopportunitiestothisantici-patoryworkandinternationalnetworking.Forthepharmaceuticalbranch,itisimportantthatFinlandisinvolvedandinfluencingtheEUmedicinespolicyandlegislation.
Actions
1.Strengthentheco-operationbetweenbasicresearchandclinicaltrialsofmedicines.
Co-operationparties:MinistryofSocialAffairsandHealth,MinistryofEducationandCulture,Fimea,NationalInstituteforHealthandWelfare,NationalCommitteeonMedicalResearchEthicsTUKIJA,universities,universitiesofappliessciences,healthcareunits,AcademyofFinland,universityhospitals,pharmaceuticalindustry,professionalorganisations
28
2.Providehealthcareprofessionalswithbetteropportunitiestoengageinclinicaltrialsofmedicines.
Co-operationparties:MinistryofSocialAffairsandHealth,MinistryofEducationandCulture,Fimea,NationalInstituteforHealthandWelfare,universities,universitiesofappliessciences,healthcareunits,AcademyofFinland,universityhospitals
3.Simplifytheadministrativeprocessesrelatedtocontractsandpermitsrelatedtopharmaceuticalresearchand,ifnecessary,revisetherespectivelegislation.
Responsibleparty:MinistryofSocialAffairsandHealth
Co-operationparties:Fimea,NationalInstituteforHealthandWelfare,Valvira,NationalCommitteeonMedicalResearchEthicsTUKIJA
4.TheMinistryofSocialAffairs andHealthwillwork incloser co-operationwiththeMinistryofEducationandCultureandtheMinistryofEmploymentandtheEconomytodeveloptheresearchoperations.
Responsibleparties:MinistryofSocialAffairsandHealth,MinistryofEducationandCulture,MinistryofEmploymentandtheEconomy
Co-operationparties:universities
5.Promotenationalandinternationalco-operationandnetworkinginpharmaceuticalresearchanddevelopmentamonghospitaldistricts,researchschools,universities,companiesandauthorities.
Responsibleparties:Fimea,FinnishFundingAgencyforTechnologyandInnovationTEKES
Co-operationparties:MinistryofSocialAffairsandHealth,MinistryofEmploymentandtheEconomy,NationalInstituteforHealthandWelfare,universities,universitiesofappliessciences,FinnishInnovationFundSITRA,pharmaceuticalindustry,AcademyofFinland,hospitaldistricts,professionalorganisation
Aims of actions:
� morepharmaceuticalresearchisdoneandtherelatedpracticesbecomelesscomplicated
� newjobsinthissectoraregeneratedinFinland� inthelongrun,thenumberofFinnishpharmaceuticalinnovationsmay
grow
29
4.2 PROMOTE RATIONAL PHARMACOTHERAPIES THROUGH EVALUATIONS OF THERAPEUTIC AND ECONOMIC VALUE OF MEDICINES
Theinformationonthetherapeuticandeconomicvalueofmedicinesandvaccines,inotherwords,theircost-effectiveness,isthefoundationfortheirrationaluse.Tobecomereimbursable,novelmedicinesmustbeaccompaniedwithahealtheconomicevaluation.Healtheconomicstudiesareusuallyperformedattheearlystagesofmedicinedevelopment.Atthatpoint,thereisnotyetanyexperienceontheimpactsofthemedicineonthepopulationlevel.
Today,therequirementsandresourcesforcost-effectivenessappraisalsofoutpatientmedicinesontheonehandandthehospitalmedicinesontheotherhandaredifferent.ThePharmaceuticalsPricingBoardhasbeenappraisingreimbursableoutpatientmedicinessince1998,whilethelimitedresourcesavailabletohospitalshavebeenallocatedtousesotherthanthemedicationsassessments.Inbothsectors,thelimitednumberofexpertsandthelackofeffectivenessdatainfluencethedevelopmentofevaluationsandthepossibilitytoestimatetherespectivecosts.Toaccumulateversatileandupdatedresearchandevaluationdataonmedicines,itisindispensablethatresearchershaveaccesstoregisterscontainingtheinformationonallprescribedanddispensedmedicinesaswellasontheintegratedcarepathwaysandtherapyoutcomes.
Morecooperationbetweentheorganisationsandresearchersinthesectorisneededtodeveloptheoperations.Accordingtotherespectivelegislation,theFimearesponsibilitiesincludeboththepharmacoeconomicresearchandthecost-effectivenessevaluations,inotherwords,theevaluationsofthethe-rapeuticandeconomicvalueofpharmacotherapies.Moreover,Fimeashouldbuildupcooperationinthesesectors.AttherequestofthePharmaceuticalsPricingBoard,Fimeacanalsoperformevaluationsrelatedtothemedicinereimbursementandpricedecisions.
Actions
1.Promotethetrainingofexpertsinpharmaceuticalepidemiologyandhealtheconomicsincollaborationwiththeauthorities,universitiesandothereducationalinstitutions.
Responsibleparties:MinistryofEducationandCulture,universities,universitiesofappliedsciences
Co-operationparties:MinistryofSocialAffairsandHealth,Fimea,MinistryofEmploymentandtheEconomy,NationalInstituteforHealthandWelfare
30
2.Ensurethattheevaluationsonthetherapeuticandeconomicvalueofmedicinesareperformedusinguniform,evidence-basedproceduresbasedonasequalcriteriaaspossible.
Responsibleparties:Fimea,SocialInsuranceInstitution
Co-operationparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,Duodecim,pharmaceuticalindustry
3.Increasenationalandinternationalco-operationinthecost-effectiveevaluationsofmedicines.
Responsibleparties:Fimea,SocialInsuranceInstitution
Co-operationparties:MinistryofSocialAffairsandHealth,NationalInstituteforHealthandWelfare,pharmaceuticalindustry,universities
4.Makeincreaseduseofevaluationsofthetherapeuticandeconomicvalueofmedicinesinthedecision-makingrelatedtothereimbursementstatusofamedicinalproduct.Promotetheuseofevaluationdatainallmedicine-relateddecision-making.
Responsibleparties:MinistryofSocialAffairsandHealth,Fimea,NationalInstituteforHealthandWelfare,SocialInsuranceInstitution
Co-operationparties:pharmaceuticalindustry
5.Create a comprehensive prescription database, accumulating theinformationonalldispensedprescription-onlymedicines.Makesurethatthesocialwelfareandhealthcareregisterscanbeutilisedintheresearchonmedicines.
Responsibleparties:Fimea
Co-operationparties:SocialInsuranceInstitution,pharmacies,hospitaldistricts,hospitalpharmacies,medicinedispensaries
Aims of actions:
� informationoncost-effectivenesshelpstoallocatetheresourcestorationaltherapies
� improvednationalandinternationalco-operationimprovesevaluationprocessesandpromotestheexchangeofinformation
� increased informationonmedicineusehelps to identify theareasrequiringnewresources
31
5 VETERINARY SERVICE SAFEGUARDS PUBLIC HEALTH AND PROMOTES WELLBEING OF HUMANS AND ANIMALS
5.1 RATIONAL USE OF VETERINARY MEDICINES GUARANTEES CONSUMER SAFETY
Theuseofveterinarymedicinesmustberationaltoensurepublichealthandconsumersafety.Controlleduseofantimicrobialmedicinesrequiresparticularattention.Animalwellbeingwillinfluencethequalityofanimal-based foodstuffs, the cost-effectiveness of animal production and thewellbeingofhumans.
Theregionalandnationalavailabilityofveterinarymedicinesmustbeensured,andtheirimportsanddistributionmustbesafe.TheFinnishvete-rinarymedicinemarketissmall,andthereforethenumberandselectionofmedicineswithmarketingauthorisationsarenotsufficienttocoverallindica-tions.Theavailabilityofseveralveterinarymedicinesandvaccinesisensuredthroughspecialpermits.Difficultiesintheaccesstovaccinesmayleadtothespreadingofanimaldiseases.Incaseofproductiondisturbances,thesmallselectionofgenericmedicinesmayhaveasignificantnegativeimpactontheavailabilityofthemedicines.Theconsequenceswouldincludeconsiderableproblemsinanimalwellbeing,nottomentioneconomiclosses.
Themedicationofproductionanimalsmustalwaystakeplacewithdueattentiontofoodsafety.Thesafetyofpharmaceuticalresidueshasbeeneva-luated,andthemedicineshaveappropriatesafetyperiodswhichmustbefollowed.Anationalmonitoringprogrammefollowspharmaceuticalresiduesinfoodstuffscomprehensivelyandsystematically.
ContrarytomanyEuropeancountries,Finlandisfreefrommanycom-monanimaldiseases,andwemustmaintainthissituation.Theinspectionofimportedvaccinebatchesandtheirhighqualityensurethatpathogenicsubstancesdonotspreadinthecountryintheformofvaccineimpurities.Ifvaccinesarenotavailable,weriskhavingseriousanimaldiseaseepidemicsthatmayalsoleadtolowerproductivity.Somevaccinesalsoprovidetheanimalswithprotectionagainstzoonoticpathogensthatmaybedangeroustohumans.
Theuseofveterinarymedicinesmustbebasedonreliableinformation.Theproductionanddisseminationofreliableandevidence-basedinforma-tiononveterinarymedicineswillpromotethecorrectandsafeuseofthemedicinesinquestion.
32
Actions
1.Promote animal health and wellbeing through better veterinaryhealthcareandmedicine,improvedlivingconditionsofanimalsandmoreactivecontrols.Emphasisepreventiveanimalhealthcareinsteadofmeretreatmentofdiseases.
Responsibleparties:MinistryofAgricultureandForestry,Evira
Co-operationparties:Fimea,MinistryofSocialAffairsandHealth,universities,foodindustry
2.Improvenation-wideavailabilityofveterinarymedicinesandtheirsufficientlycomprehensiveselection.Ensuretheavailabilityofanimalvaccinesduringepidemics.
Responsibleparties:Fimea,MinistryofSocialAffairsandHealth,pharmaceuticalindustry,pharmaceuticalwholesalers,pharmacies
Co-operationparties:MinistryofAgricultureandForestry,Evira,universities
3.Communicateactivelyontheappropriateuseofveterinarymedicinesthroughchannelsclosetotheusers.InformationontherisksofillegalimportationandInternettrade.
Responsibleparties:Fimea,Evira
Co-operationparties:MinistryofAgricultureandForestry,universities,professionalorganisations,pharmacies,pharmaceuticalindustry
4.Developmonitoringsystemsfocusingontheconsumptionanduseofantimicrobialsusedonanimals,creatingsufficientsystemstoaccumulateinformationon theuse, dispensing andprescriptionof veterinarymedicinesfordifferentindications,brokendownbyanimalspecies.Promotedcompliancewithantimicrobialrecommendations.
Responsibleparties:Fimea,MinistryofAgricultureandForestry,Evira
Co-operationparties:MinistryofSocialAffairsandHealth,universities,professionalorganisations,pharmacies,pharmaceuticalindustry
33
5.Promote sensitivitymonitoringofmicrobes isolated fromanimals,launchingpermanentpublicationsthatreportontheantimicrobialresistancesituationrelatedtobothhumanandanimalmedicine.
Responsibleparties:Evira,NationalInstituteforHealthandWelfare,MinistryofAgricultureandForestry
Co-operationparties:Fimea,MinistryofSocialAffairsandHealth,universities
6.Promoteco-operationbetweenpharmaceuticalexpertsandenhanceanimalmedicationcontentsinthebasiceducationofvariousprofessionalgroups.
Responsibleparties:MinistryofAgricultureandForestry,Fimea,Evira
Co-operationparties:MinistryofSocialAffairsandHealth,universities,professionalorganisations
7.Draftanationalstrategyforproducingreliableandunderstandableveterinarymedicineinformation.
Responsibleparties:Fimea,MinistryofSocialAffairsandHealth
Co-operationparties:Fimea,MinistryofSocialAffairsandHealth,MinistryofAgricultureandForestry,Evira,universities,professionalorganisations,pharmaceuticalindustry
Aims of actions:
� theaccesstoveterinarymedicinesimprovesandtheirusebecomesincreasinglyrational
� foodsafetyremainsatagoodlevel� theuseofantimicrobialsismoreappropriate� informationontheproperuseofveterinarymedicinesismoreaccessible
totheauthoritiesandmedicineusers� thedevelopmentofpreventivehealthcareofproductiveanimalsenhances
theprofitabilityofagriculture
34
6 FOLLOW-UP PLAN FOCUSING ON IMPLEMENTATION OF PROPOSED MEDICINES POLICY 2020 ACTIONS
TheMedicinesPolicydocumentoutlinestherespectivedecision-makinguntiltheyear2020.TheMinistryofSocialAffairsandHealthwillleadtheworkfortheattainmentofmedicinespolicyobjectives.ThestrategicsteeringtakesplacethroughtheperformanceagreementsbetweentheMinistryandtheagenciesunderitsumbrella.However,toreachtheobjectives,allpharmaceuticalbranchstakeholdersneedtocollaborate.
6.1 PRACTICAL ACTIONS AND EVALUATION OF IMPACTS
Thedefinitionofthepracticalactionsunderthemedicinespolicyoutlinesandtherespectiveevaluationarecontinuousprocesses.Thisworktakesplaceincollaborationwiththestakeholdersinthepharmaceuticalbranch.
Theobjectivesandtheneedformeasureswillberevisedatregularinter-vals.Twomonitoringgroupswillbeestablishedforthepurpose:
a)MedicinesGroupconstitutedbythepharmaceuticalauthorities(MinistryofSocialAffairsandHealth,Fimea,SocialInsuranceInstitution,NationalInstituteforHealthandWelfare,Valvira,FinnishFoodSafetyAuthorityEvira,andMinistryofAgricultureandForestry),meetingonceayear.
b)Pharmaceutical Forum constituted by the pharmaceutical branchstakeholders,meetingeverytwoyears.
TheMinistryofSocialAffairsandHealthwillconvenethemonitoringgroups.Usingspecificallydevelopedindicators,theFinnishMedicinesAgencyFIMEAand,ifnecessary,theotheragencieswillgatherinformationonthesuccessofthemedicinespolicyactionsandattainmentofobjectivesforthemonitoringgroups.
Theimpactsoftheactionscanbeevaluatedfrommanyperspectives,inclu-dingthatoftheindividualpatient,societyorthepharmaceuticalbranchsta-keholders.TheMedicinesPolicy2020documentliststheadvantagesthattheactionsareexpectedtogenerate,mostlyforthecustomersandthepatients.Inthefuture,theevaluationswillbeextendedandthepotentialadvantages,disadvantagesandcosteffectswillbeanalysedmoreprofoundlyandfromotherangles.Asfaraspossible,theevaluationtoolswillbeevidence-basedmeters.
35
6.2 TIMETABLEThepreparationsfortheMedicinesPolicy2020startedinJanuary2010.
Thedevelopmentofthepracticalactionsunderthemedicinespolicyout-linesaswellastheimpactindicatorsstartedinlate2010.Atthisstage,twobenchmarkpointsfortherevisionoftheactionswillbeset.ThefirstoneisthemeetingoftheMedicinesGroup,constitutedbythepharmaceuticalsectorauthorities,intheautumnof2011.Atthisvenue,themedicinespo-licyobjectivesandactionswillberevisedasperthepublicationofthenewGovernmentprogramme.
ThePharmaceuticalForumconstitutedbythestakeholdersisthesecondbenchmarkpoint.TheForumwillbeconvenedin2012,anditwillanalysetheimplementationandmeasuringofthemedicinespolicyfromtheperspectiveofthestakeholders.TheMedicinesGroupwillalsoconvenein2012,andthefuturebenchmarkpointsandpracticalactionswillbeagreeduponinthesemeetings.
36
APPENDIX 1
Healthcare expenditure in 1995-2008 at 2008 prices, in millions euro
Gross investments in healthcare
Travelling
Administrative expenses of healthcare
Equipment and other medicinal durables
Medicines and other medicinal consumables
Other healthcare
Private healthcare (reimbursed from health insurance)
Inpatient care of older persons
Occupational and student healthcare Dental healthcare
Primary healthcare (excluding occupational, student and dental healthcare)
Specialised medical care
Source: National Institute for Health and Welfare 2010
18 000
16 000
14 000
12 000
10 000
8 000
6 000
4 000
2 000
01995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
37
APPENDIX 2
Cen
tral
figu
res
on m
edic
ine
sale
s an
d re
imbu
rsem
ents
in 2
009
20
04
2005
20
06
2007
20
08
2009
in
mill
ions
eu
ro
chan
ge
from
the
pr
evio
us
year %
in
mill
ions
eu
ro
chan
ge
from
the
pr
evio
us
year %
in
mill
ions
eu
ro
chan
ge
from
the
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year %
in
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ions
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ge
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the
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us
year %
in
mill
ions
eu
ro
chan
ge
from
the
pr
evio
us
year %
in
mill
ions
eu
ro
chan
ge
from
the
pr
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us
year %
Ove
rall
sale
s of
m
edic
ines
2 28
87,
12
435
6,4
2 36
2-1
,62
500
5,9
2 66
46,
52
608
-2,1
sale
s of
out
patie
nt
pres
crip
tion
med
icin
es
(ret
ail p
rice
s, in
clud
ing
taxe
s)
1 68
57,
71
756
4,2
1 74
4-0
,21
817
4,2
1 93
56,
51
893
-2,2
sale
s of
out
patie
nt
self-
care
med
icin
es
(ret
ail p
rice
s, in
clud
ing
taxe
s)
278
3,0
319
14,5
238
-18,
527
515
,529
05,
530
13,
8
hosp
ital s
ales
(re
com
-m
ende
d w
hole
sale
pr
ices
)32
57,
836
011
,037
95,
440
87,
543
87,
541
4-5
,5
Sour
ce: F
inni
sh M
edic
ines
Age
ncy
Fim
ea, S
ocia
l Ins
uran
ce In
stit
utio
n
38
APPENDIX 3
Organisations involved in the preparation of the Medicines Policy 2020
MinistryofSocialAffairsandHealthFinnishMedicinesAgencyFimea
NationalSupervisoryAuthorityforWelfareandHealthValvira
Social Insurance Institution Ministry of Social Affairs and Health/PharmaceuticalsPricingBoard
MinistryofSocialAffairsandHealth/InsuranceDepartment
MinistryofAgricultureandForestryFinnishFoodSafetyAuthorityEvira
Hospitalpharmacies
Hospitaldistricts
Co-operationorganisationofthesocialwelfareandhealthorganisationsYTY
AssociationofFinnishPharmacies
TheFinnishPharmacists'Association
SuomenProviisoriyhdistys(FinnishAssociationofSeniorPharmacists)
AssociationofFinnishLocalandRegionalAuthorities
FinnishMedicalAssociation
FinnishDentalAssociation
FinnishVeterinaryAssociation
TheFinnishUnionofPracticalNursesSuPer
UnionofHealthandSocialCareProfessionalsTehy
Pharmacywholesalers
UniversityofHelsinki
UniversityofEasternFinland
UniversityofTurku
UniversityofTampere
ÅboAkademiUniversity
PharmaIndustryFinlandPIF
FinnishGenericPharmaceuticalIndustry
FederationofFinnishPatients
FinnishMedicalSocietyDuodecim
HelsinkiUniversityPharmacy
39
APPENDIX 4
Abbreviations used in the Medicines Policy 2020 document
Abbreviation DefinitionEU EuropeanUnion
Evira FinnishFoodSafetyAuthority
Fimea FinnishMedicinesAgency
CMR comprehensivemedicationreview
Rohto CentreforPharmacotherapyDevelopmentRohto
SFL FinnishPharmacyFederation
SITRA FinnishInnovationFundSITRA
Stakes NationalResearchandDevelopmentCentreforWelfareand Health
TEKES FinnishFundingAgencyforTechnologyandInnovation
TUKIJA NationalCommitteeonMedicalResearchEthics
Valvira NationalSupervisoryAuthorityforWelfareandHealth
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APPENDIX 5
Definitions used in the Medicines Policy 2020 document
1) Pharmaceutical service (Pharmaceutical sector)
Pharmaceutical serviceAwholetoensuretheavailabilityofefficient,safeandreasonablypricedmedicines.Theelementsincludedarepharmaceuticaldevelopmentandproduction,imports,wholesaleandretaildistributionofpharmaceuticals,prescriptionofmedicines,researchontheuseofmedicinesandpharmaceuticalserviceresearch,medicinesreimbursementsystem,pharmaceuticalserviceadministration,obligatorystockpilingandsecurityofsupply.Pharmaceuticalservicecomprisesbothoutpatient/non-institutionalandinpatientcare.
2) Patient safety, medicine/drug safety and medication safety
Patient safetyPrinciplesandactionsofthehealthcareunitsandorganisations,withthepurposeofensuringthesafetyofthecareandprotectthepatientfromanyharm;fromthepatient’spointofview:thatthecaredoesnotcauseanysignificantadverseeffect;comprisesboththesafetyofthecare,medicationsafetyandsafetyofthedevicesasapartofthecarequality(Source:NationalResearchandDevelopmentCentreforWelfareandHealthStakesandCentreforPharmaceuticalDevelopmentRohto,2006
Safe medication Safe medication comprises drug safety and medication safety (Fimeaadministrativeregulation7/2007,StakesandRohto2006).
Drug/medicine safety Thetermmostlycomprisesthesafetyofthemedicineseenasaproduct:theknowledgeandevaluationofthemedicine'spharmacologicalpropertiesandeffects,itshigh-qualitymanufacturingprocessaswellastheinformationonthepackageandotherproductinformation.Theefficacyandsafetyofmedicinesisevaluatedthroughthemarketingauthorisationprocedure.Theconcernforadversereactions(ADR)alsocontinuesafterthemarketingauthorisationhasbeengranted(so-calledsubsequentsupervision,inotherwordspharmacovigilance)(Source:StakesandRohto2006).
Medication safety Thesafetyinrelationtotheuseofmedicines.Thetermcoverstheprinciplesandoperationsofthesocialwelfareandhealthcareunits,gearedatensuringthesafetyofpharmacotherapiesandprotectingthepatientfromharm.
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Medicationsafetycomprisesactionstoprevent,avoidandrectifyadverseeventsrelatedtotheuseofmedicines(Source:StakesandRohto2006).
User safety Preventionofharmcausedtohumansbyhandlingordosageofveterinarymedicines.
3) Rational pharmacotherapy, monitoring of drug treatment, comprehensive medication review CMR as well as rational self-medication
Rational pharmacotherapy Rationalpharmacotherapyisefficient,safe,cost-effectiveandpurposefulpharmacotherapy(WHO).
Monitoring of drug treatment Partofthemedicationprocess,seemedicationprocess.
Drug utilisation/regimen review/Medication reviewReviewofanindividualpatient’smedicationbyahealthcareprofessional(physician,nurse,seniorpharmacist,pharmacist)checkingthemedicinedosageandadministrationtimesagainsttheapprovedclinicalpractice,detectingeventualoverlappingorincompatiblemedications.Performedasanelementofnormaldoctor’sappointment,dispensingofthemedicineatthepharmacyordistributionatahospitalwardorinhomecare.Thepharmacyalsomakesreviewsforself-caremedicines.Doesnotincludetheevaluationofmedicationneedorindication(AdaptedfromPeuraetal2007).
Medication assessment/review Asapartofthenormalpatientexaminationandtreatmentplanningprocess,areviewofanindividualpatient’smedication,itsneedandrationality,madebyaphysicianandassistedbyotherhealthcareprofessionals,ifnecessary.
Comprehensive medication assessment, comprehensive medication review (CMR), medication therapy management service Thesolutionofanindividualpatient’smedicationproblems,initiatedbytheattendingphysicianincollaborationwithclinicalexpertsand/oraninterprofessionalgroup.Inadditiontotheassessmentbytheattendingphysician,CMRcanincludeathoroughanalysisofthemedicationwholeandproposedactions,performedbyaclinicalpharmacologist,speciallytrainedseniorpharmacistorpharmacistorotherspeciallytrainedhealthcareprofessional(AdaptedfromPeuraetal.2007).
Self-medicationSelf-medicationbasedonself-caremedicines(seealsoitem5).
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4) Integrated care pathway, individual treatment pathway, pharmacotherapy process, unit-based and individual pharmacotherapy plan, interprofessional collaboration and ward pharmacy
[Disease based] integrated care pathway, pathway of care, clinical pathway, seamless careOrganisation-oriented,plannedandindividuallyimplemented,regionallyagreedwholeoftreatmentprocessedtargetedatthesameclient/patientand theirparticular symptoms.Basedon theagreementsbetween theorganisationsonthearrangementofthetreatmentofaparticulardisease(Source:Norbacketal.2010)
Individual treatment pathway Theindividualtreatmentpathways(also 'carepathway’)referto inter-organisationalplannedandindividuallyimplementedwholeoftreatmentprocessestargetedatthesameclient’sparticularsymptoms.Theindividualtreatmentpathwaysrequirethatoneunitisresponsiblefortheguidanceandmonitoringoftheservicesprovidedtotheclient(Source:Norbacketal.2010).
Pharmacotherapy process Apatient’spharmacotherapyprocessisanoperativechaincomprisingtheassessmentofmedicationneed,thechoiceanddispensingofthemedicine,itsdosageandadministration,thepatient’smotivation,adviceandcommitmenttothepharmacotherapy,organisationofthetreatmentfollow-upandtheevaluationoftheoutcome,aswellasensuringtheinformingofthepatientandtheorganisationsandpersonsinvolvedinthetreatment.Apatient-specificpharmacotherapyplanispartofthepharmacotherapyprocess.
Unit-based pharmacotherapy plan, unit-based medicines management plan PerformedinlinewiththeinstructionsissuedbytheMinistryofSocialAffairsandHealth,aplanontheimplementationofpharmacotherapiesinpublicandprivatesocialwelfareandhealthcareunits.Themanagementofthesocialwelfareorhealthcareunitisinchargeoforganisingthedrafting,implementationandfollow-upofthepharmacotherapyplan.Thehospitalpharmacyormedicinedispensaryresponsibleforthepharmaceuticalserviceintheunitwillparticipateinthedraftingofthepharmacotherapyplan(STM2006,Fimeaadministrativeregulation7/2007).
Individual pharmacotherapy plan Partofapatient’streatmentplan.Regularlyupdatedandincludedinthepatientrecords,asummaryonthemedicinesusedbythepatient,theirindications,treatmentobjectives,medicinedosageaswellastreatmentfollow-up and duration. This plan constitutes the basis for individualpharmacotherapy,decreasingtheerroneoususeofmedicines.
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Interprofessional collaboration Ininterprofessionalcollaboration,variousprofessionalgroupscoordinatetheiractioninthebestinterestofthepatient,alsounderstandingthetasksandresponsibilitiesofotherprofessionalgroupsinthetreatmentofthepatientaswellastheimportanceofexchangeofinformationbetweentheprofessionalgroups(Source:Zwarensteinetal.2009).
Ward pharmacy Wardpharmacy is thepharmaceutical serviceworkperformedby thepharmaceuticalstaffatthewards(Fimeaadministrativeregulation7/2007).
5) Customer-orientation, treatment adherence, concordance, self-management, self-care
Customer oriented services, patient oriented servicesTheorganisation’sapproach in theplanningand implementationof itsoperationsfromthecustomer/patientperspective.
Compliance Thepatientfollowsthemedicalinstructionswithoutnecessarilyhavingadeeperinsightofthem(WHO2003).Inveterinarymedicine,thismeansthatthemedicationadministeredbytheownertakesplaceaccordingtotheveterinarian'sinstructions.
Adherence Responsibleandactiveself-carebythepatient,inawaycomplyingwiththestateofhealthandincollaborationwiththehealthcareprofessionals(Kyngäs1995).
Concordance Jointunderstandingonthetreatmentasaresultofanegotiationbetweenthepatientandthehealthcareprofessional.Inordertoimprovetheconditionsforrationalpharmacotherapy,thenegotiationalsoaddressesthepatient'swishes,beliefsandunderlyingknowledge.
Self-management Anoperationalmodelpromotingadherencetotreatmentwherethepatientisdirectedtotakeindividualresponsibilityfortheircare.Thisincludesactionstomaintainandpromotehealthandfollow-upandtreatmentofthesymptomsofthedisease,gearedtomanagetheimpactofthediseaseonthepatient’soperatingcapacity,emotionsandsociallife.
Self-care Theindividual’svoluntaryoperationtargetedatmaintainedhealth.Rationaluseofself-caremedicinesispartofself-care.Inanimals,theveterinaryself-caremedicinesareusedrationallyandwithcautiontomaintaintheirhealth.
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6) Efficacy, effectiveness, cost-effectiveness (efficiency) and incremental cost-effectiveness ratio (ICER)
Efficacy Theeffectofthetreatmentunderidealcircumstances,observedincloselymonitoredtestconditionsonselectedpatients.Theproofofefficacyisoneofthepreconditionsforthegrantingofthemarketingauthorisationforamedicinalproduct.Replytothequestion:canthetreatmentwork?
Effectiveness Theimpactofthetreatmentobtainedatthepopulationlevel,innormalconditionsandonunselectedgroupofpatients.Replytothequestion:willthetreatmentworkinpractice?
Cost-effectiveness (= efficiency) Therelationbetweentheeffectivenessofthetreatmentandtheresources(costs)incurredforadministeringit.Replytothequestion:isthetreatmenteconomicallyfeasible?
Incremental cost-effectiveness ratio ICER ICERshowshowmanymoremonetaryunitsmustbepaidforeachextraunitofbenefits(suchasavoidedharm,additionallifeyear,quality-adjustedlifeyearQALY.Sources:Goldetal.1996,Drummondetal.2005,SintonenandPekurinen2006,Mäkeläetal.2007).
7) Pharmaceutical research Atalllevelsandareasofpharmaceuticalorveterinarypharmaceuticalservice,operationstargetedatthedevelopmentofmedicinesandtheinvestigationoftheirpropertiesorimpacts,theadvantagesgainedoradverseeffectscausedbythem.
Clinical researchExperimentalresearchandtrialsonhumans,mostlytargetedatdemonstratingtheefficacyandsafetyofamedicineorotherformoftherapy.
Basic researchResearchcomprisesbasicresearchandappliedresearch.Themainpurposeofbasicresearchistoincrementgeneralknowledge,therebyunderstandingthelinksbetweenvariousvariables.
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8) Pharmaceutical information
Pharmaceutical (drug/medicines) information Informationaboutmedicinesandpharmacotherapies,availabletoconsumersandhealthcareprofessionalsthroughvariousinformationchannels,eitherface-to-faceorthroughwrittenorelectronicservices(telephone,Internet,TVandradio).Pharmaceuticalinformationisproducedbytheauthorities,healthcareprofessionals,thepharmaceuticalindustryandpatientorganisations.Thebasisofmedicine-specificinformationisthesummaryofproductcharacteristics,SPC)adoptedtogetherwiththemarketingauthorisation,aswellasthepackageleafletbasedonit.(Sources:Directive2001/83/EC,Pohjanoksa-Mäntylä2010,Salonen2010).
Patient/medication counselling Adiscussionbetweentheclient/patientandthehealthcareprofessionalwheretheprofessional,takingtheclient’spersonalneedsandsituationintoconsideration,supportshisorhercopingwiththepharmacotherapy(Sources:USP1997,HakkarainenandAiraksinen2001)
9) Veterinary serviceAnimalhealthcareandtreatmentofanimaldiseasesaswellasotherveterinaryassistance,meatandmilkinspection,health-relatedcontrolandinspectionoftheproductionofanimal-basedfoodstuffsandanimalhusbandry,fightingandpreventionofveterinarydiseasesaswellasanimalprotection(VeterinaryServiceAct685/1990).