ImprovingPatient andHealthSystem Outcomesthrough Advanced PharmacyPractice

AReporttotheU.S. SurgeonGeneral2011
OfficeoftheChiefPharmacist

Rev:5/2011,8/2011,12/2011

SuggestedCitation

GibersonS,YoderS,LeeMP.ImprovingPatientandHealthSystemOutcomes throughAdvancedPharmacyPractice.AReporttotheU.S.SurgeonGeneral. OfficeoftheChiefPharmacist.U.S.PublicHealthService.Dec2011.


AUTHORS
RADMScottGiberson,RPh,PhC,NCPSPP,MPH ChiefProfessionalOfficer,Pharmacy Director,CommissionedCorpsPersonnelandReadiness U.S.AssistantSurgeonGeneral U.S.PublicHealthService Rockville,MD CDRSherriYoder,PharmD,BCPS ComparativeEffectivenessResearchProgramPrincipalConsultant IndianHealthService Rockville,MD CDRMichaelP.Lee,PharmD,NCPS,BCPS Director,PharmacoeconomicandTherapeuticsResearch ViceChair,IndianHealthServiceNationalP&TCommittee IndianHealthServiceOklahomaCityAreaOffice OklahomaCity,OK CONTRIBUTORS CAPTChrisBina,PharmD ChiefPharmacist FederalBureauofPrisons Washington,DC MonicaMBowen,PharmD,BCPS ClinicalPharmacySpecialist,AmbulatoryCare VeteransAffairsMedicalCenter Lebanon,PA CAPT(Ret.)RandyW.Burden,PharmD,MDiv,PhC,BCADM,CDE,CLS,FNLA Diplomate,AccreditationCouncilofClinicalLipidology FormerAlbuquerqueAreaIHSRegionalClinicalPharmacyConsultant SantaFe,NM CDRChristopherLamer,PharmD,MHS,BCPS,CDE ProgramAnalyst OfficeofInformationTechnologyandHealthEducation IndianHealthService Cherokee,NC SusanMontenegro,PharmD,MPH ClinicalPharmacist UnionMemorialHospital Baltimore,MD


CDRKristaPedley,PharmD,MS Director OfficeofPharmacyAffairs HealthResourcesandServicesAdministration Rockville,MD PharmacistProfessionalAdvisoryCommittee(PharmPAC) U.S.PublicHealthService Rockville,MD RADM(Retired)RobertPittman,RPh,MPH FormerChiefProfessionalOfficer,Pharmacy U.S.AssistantSurgeonGeneral(Retired) U.S.PublicHealthService Rockville,MD CDRRyanSchupbach,PharmD,NCPS,BCPS ClinicalPharmacyDirector&ResidencyProgramDirector ClinicalAssistantProfessor UniversityofOklahomaCollegeofPharmacy ClaremoreIndianHospital IndianHealthService Claremore,OK LTYiyingTsai,PharmD,MPH Pharmacist U.S.FoodandDrugAdministration SilverSpring,MD CAPTChrisWatson,RPh,MPH PrincipalPharmacyConsultant IndianHealthServiceHeadquarters Rockville,MD CAPTTravisWatts,PharmD,BCPS,CDE SoutheastRegionCommissionedCorpsLiaison DivisionofCommissionedPersonnelSupport IndianHealthService OklahomaCity,Oklahoma


EXECUTIVESUMMARY.................................................................................................................... 7 INTRODUCTION............................................................................................................................. 11 OBJECTIVES...................................................................................................................................14 DISCUSSION ...................................................................................................................................15 FocusPoint1:PharmacistsIntegratedasHealthCareProviders............................................15 DefinitionsofPrimaryCare................................................................................................... 15 PharmacistRoles................................................................................................................... 17 InterprofessionalCollaborationandSupport ........................................................................19 FocusPoint2:RecognitionasHealthCareProviders...............................................................23 AdvancedPharmacyPracticeModels................................................................................... 23 PharmacyEducationandTraining........................................................................................ 26 FocusPoint3:CompensationMechanisms..............................................................................29 EssentialforSustainability.................................................................................................... 29 LegislationHistory................................................................................................................. 31 MedicationTherapyManagement(MTM)underMedicarePartD.....................................33 FocusPoint4:EvidenceBasedAlignmentwithHealthReform..............................................36 QualityofCareandPatientOutcomes.................................................................................36 DiseasePreventionandManagement.................................................................................. 38 CostEffectivenessandCostContainment............................................................................40 PrimaryCareWorkforce........................................................................................................ 42 AccesstoCare....................................................................................................................... 44 CONCLUSION.................................................................................................................................46 APPENDICES..................................................................................................................................48 AppendixA:NationalClinicalPharmacySpecialist(NCPS)Program........................................49 AppendixB:OutcomesRepositorySpreadsheet......................................................................51 AppendixC:U.S.CollaborativePracticeMap...........................................................................79 AppendixD:PhysicianSurvey................................................................................................... 80 REFERENCES..................................................................................................................................86


RELEVENTACRONYMS
AACP AAFP AAMC ACA ACPE ADE APhA ASHP BOP BPS CCP CDTM CGP CMS CPA CPHIMS CPP CPS DMAA DOD HCFA HRSA I/T/U ICP IHS IOM MedPAC MTM MTMP NAPLEX NCCPC NCPS NCPSC NP NPP OSG PA PCMH PCP PDP PSPC VA AmericanAssociationofCollegesofPharmacy AmericanAcademyofFamilyPhysicians AssociationofAmericanMedicalColleges AffordableCareAct AccreditationCouncilforPharmacyEducation AdverseDrugEvent AmericanPharmacistsAssociation AmericanSocietyofHealthSystemPharmacists FederalBureauofPrisons BoardofPharmacySpecialties ChronicCareProfessional CollaborativeDrugTherapyManagement CertifiedGeriatricPharmacist CentersforMedicare&MedicaidServices CollaborativePracticeAgreement CertifiedProfessionalinHealthcareInformationandManagementSystems ClinicalPharmacistPractitioner ClinicalPharmacySpecialist DiseaseManagementAssociationofAmerica U.S.DepartmentofDefense HealthCareFinancingAdministration HealthResourcesandServicesAdministration IHS,Tribal,andUrban InfectionControlProfessional IndianHealthService InstituteofMedicine MedicarePaymentAdvisoryCommission MedicationTherapyManagement MedicationTherapyManagementProgram NorthAmericanPharmacistLicensureExamination NorthCarolinaCenterforPharmaceuticalCare NationalClinicalPharmacySpecialist NationalClinicalPharmacySpecialistCommittee NursePractitioner NonPhysicianPractitioners U.S.OfficeoftheSurgeonGeneral PhysicianAssistant PatientCenteredMedicalHome PrimaryCareProvider PrescriptionDrugPlan PatientSafetyandClinicalPharmacyServicesCollaborative U.S.DepartmentofVeteransAffairs


EXECUTIVESUMMARY The2011ReporttotheU.S.SurgeonGeneralisanupdateofapreviouslysubmittedReportin 2009tothenActingSurgeonGeneral,RADMStevenGalson.The2011Reportprovideshealth leadershipwithevidencebaseddiscussionaboutimprovingpatientandhealthsystem outcomesthroughanadditionalparadigmofhealthcaredeliveryforexpandedimplementation intheUnitedStates.The2011Reportprovidesrationaleandcompellingdiscussiontosupport healthreformthroughpharmacistsdeliveringexpandedpatientcareservices.Incollaboration withotherproviders,thisisanexisting,accepted,andadditionalmodelofimprovedhealthcare deliverythatmeetsgrowinghealthcaredemandsintheUnitedStates. Healthcaredelivery(includingpreventiveorsupportivecare)intheUnitedStatesischallenged bydemandsofaccess,safety,quality,andcost.Thesechallengesareamplifiedbyprovider workforceshortagesanddramaticincreasesinprimaryandchroniccarevisits.Projections suggestworseningofthissituation.Neworadditionalparadigmsofcaremustbeimplemented toreducetheseburdens.Currenthealthcaredemandsprovideanopportunityforhealth leadershiptorecognizeandadoptadditionalandsuccessfulhealthcaredelivermodels. Healthreformhasstimulatedexplorationofinnovativecareandpaymentreformmodelsthat canimproveaccesstocare,providequalitycare,containcosts,andaffordsafeuseof medicationsandotherpertinentmedicationrelatedissues.Thefederalsectorhasalready implementedandembracedsuchahealthcaredeliverymodelthroughphysicianpharmacist collaboration.Thiscollaboration,throughextensiveperformancedata,hasdemonstratedthat patientcareservicesdeliveredbypharmacistscanimprovepatientoutcomes,promotepatient involvement,increasecostefficiency,andreducedemandsaffectingthehealthcaresystem. Foroverfortyyears,federalpharmacistshavecollaborativelymanageddiseasethrough medicationuse,andothercognitiveandclinicalpharmacyservices.1Althoughthesemodelsare acceptedinthenonfederalsector,utilizationisoftenimpededduetopolicy,legislation,and compensationbarriersthatwillbediscussedinthisReport. TheReportisframedaroundfourfocuspointsthatclearlyarticulateandpresentevidence baseddatathatobjectivelyillustrateimprovedhealthcaredeliverythroughtheuseof pharmacistdeliveredpatientcare.Asubstantialamountofpublishedliteraturefrompeer reviewedjournalshasbeencollectedandanalyzedtosupportthediscussion. FocusPoint1discusseshowpharmacistsarealreadyintegratedintoprimarycareashealth careproviders.Pharmacistsunquestionablydeliverpatientcareservicesinavarietyofpractice settingsthroughcollaborativepracticewithphysiciansoraspartofahealthcareteam. Definitionsofprimarycareassistustoenumeratetheseintegratedroles,andthelonghistory ofsuccessfuldeliverydemonstratesalevelofinterprofessionalcollaborationandsupport. Afteraninitialdiagnosisismade,pharmacistsdelivermanypatientcareservicesandfunction ashealthcareprovidersinavarietyofpracticesettingsthroughcollaborativepractice


agreements(CPAs),tomanagediseaseinpatients(wheremedicationsaretheprimarymodeof treatment).Pharmacistscan: Performpatientassessment(subjectiveandobjectivedataincludingphysicalassessment); Haveprescriptiveauthority(initiate,adjust,ordiscontinuetreatment)tomanagedisease throughmedicationuseanddelivercollaborativedrugtherapyormedicationmanagement; Order,interpretandmonitorlaboratorytests; Formulateclinicalassessmentsanddeveloptherapeuticplans; Providecarecoordinationandotherhealthservicesforwellnessandpreventionofdisease; Developpartnershipswithpatientsforongoing(followup)care TheAmericanAcademyofFamilyPhysicians,theInstituteofMedicine,andtheCareContinuum Alliancealldescribethemanyfacetsofprimarycare.Onceadiagnosisismadebytheprimary careprovider,pharmacistsdomanagediseaseandprovidepatientcare.Pharmaciststhat performintheserolesfunctionashealthcareproviders.Pharmacistsareuniquelypositioned (throughtheiraccessibility,expertiseandexperience)toplayamuchlargerpatientcarerolein theU.S.healthcaredeliverysystemtomeetthesedemandsandimprovethehealthofthe nation.However,pharmacistsmaybetheonlyhealthprofessionals(whomanagedisease throughmedicationsandprovideotherpatientcareservices)whoarenotrecognizedin nationalhealthpolicyashealthcareprovidersorpractitioners.Legislation,policy,and compensationmechanismsthuslimitoptimalpatientoutcomesandreducethepositiveimpact onthepatientandthehealthcaresystem. FocusPoints2&3discusshowtosustainthesevalueaddedpatientcareservicesdeliveredby pharmacists.Forpharmaciststocontinuetoimprovepatientandhealthsystemoutcomesas wellassustainvariousrolesinthedeliveryofcare,theymustberecognizedashealthcare providersbystatutevialegislationandpolicy,andbecompensatedthroughadditional mechanismscommensuratewiththelevelofservicesprovided(andwithotherpractitioners providingcomparableservices).Pharmacistswithapprovedprivileges,whocurrentlyperformin expandedclinicalrolestomanagediseaseanddeliverotherpatientcarefunctions,arenot recognizedbytheSocialSecurityAct2orCentersforMedicare&MedicaidServices(CMS)as healthcareprovidersorNonPhysicianPractitioners(NPPs).TheSocialSecurityAct appropriatelyrecognizesanumberofotherhealthcareprofessionalsashealthcareproviders orpractitioners,includingphysicianassistants,nursepractitioners,certifiednursemidwives, clinicalsocialworkers,clinicalpsychologists,andregistereddieticians/nutritionprofessionals. Thesehealthprofessionalshavemultipleandvariedareasofexpertiseandprovidesomefacets ofprimarycare,yetalldeliverpatientcareservices.Pharmacistsprovideexpertiseandhealth caredeliveryinanumberofwaysfromprimaryprevention,tocounselingandadherence programs,tocomprehensivemedicationandchronicdiseasemanagementandarenotyet recognizedinthisimportantpieceoflegislation.Thisomissionisdespiteevidencethat medicationsareinvolvedin80percentofalltreatments(andimpacteveryaspectofapatients life),anddrugrelatedmorbidityandmortalitycostthiscountryalmost$200billionannually.3 Failuretorecognizeexpandedrolesofpharmacistslimitsthepotentialforpatientsandour healthcaresystemtobenefitfromaccesstoadditionalqualityprimarycareservices.Exclusion


ofpharmacistsashealthcareprovidersalsoeliminatesanysubsequentservicesustaining compensation.Pharmacistsareincreasinglyrequestedbymanyhealthsystems,providers,and primarycareteamstoimproveoutcomesanddeliveryofcare.However,intermsofpharmacist services,asthecomplexityorlevelofclinicalserviceincreases,therevenuegeneration potentialisreduced.Thisisinstarkcontrasttotheclinicalservicesprovidedbyotherhealth professionals.Inboththepublicandprivatesectors,healthsystemsarefiscallychallengedto sustainanyclinicalservicewithouttheabilitytogeneraterevenue. FocusPoint4discussesandcollatesthenumerousarticles,systematicreviewsandmeta analysesofpositivepatientandhealthsystemoutcomesthathavebeenpublishedinpeer reviewedjournalsthatvalidatethismodelasevidencebased.Accordingtoarecent comprehensivesystematicreviewof298researchstudies,integratingpharmacistsintodirect patientcareresultsinfavorableoutcomesacrosshealthcaresettingsanddiseasestates.4 Pharmacistswithlargerrolesinpatientcareimproveoutcomes,increaseaccesstocare (especiallyformedicallyunderservedandvulnerablepopulations),shifttimeforphysiciansto focusonmorecriticallyillpatientsinneedofphysicianbasedcare,improvepatientand providersatisfaction,assurepatientsafety,enhancecosteffectiveness,andclearlyadvance andimprovehealthcaredelivery. Anopportunityexistsforhealthleadershipandpolicymakerstosupportandimplement additional,existingandevidencebasedmodelsofcosteffectivepharmacistdeliveredpatient careasthefollowingdemandswithinourhealthsystemescalate: ChronicCare.ChronicdiseasesaretheleadingcausesofdeathanddisabilityintheUnited States.Chronicdiseasescurrentlyaffect45%ofthepopulation(133millionAmericans), accountfor81%ofallhospitaladmissions,91%ofallprescriptionsfilled,76%ofphysician visits,andcontinuestogrowatdramaticrates.5Additionally,ofallMedicarespending,99% goestobeneficiarieswithchronicdisease.6 Accesstocare.Medicallyunderservedpatientsseekingahealthcarehomeandthegrowth ofprimarycarevisitsaretwocomponentsthatleadtoinsufficienttimeforfocusedor comprehensivediseaseormedicationmanagementandotherrelatedhealthcareissues. Providerworkforce.Theprimarycareworkforcemaynotbeabletomeetthedemandsof increasedaccesstocare.Physicianshortagesandmaldistributionofhealthcareproviders impacthowweaddressthisissue.TheproportionofnewlygraduatedU.S.medicalstudents whochooseprimarycareasacareerhasdeclinedby50%since1997.7Currently,itis estimatedthatover56millionAmericanslackadequateaccess(notcoverage)toprimary healthcarebecauseofshortagesofprimarycarephysiciansintheircommunities.8As millionsofnewbeneficiariesenterthehealthcaresystem,thesituationwillmostlikely worsen. Currently,theAffordableCareActseekstoguaranteemorehealthcarechoicesandenhance thequalityofhealthcareforallAmericans,whilemakinghealthcareaffordable.9Innovative practicemodelsneedtobeconsidered,especiallywiththecurrentshortageofprimarycare providersandlimitedresources,inordertoaddressthesechallenges.Inmedicallyunderserved 9


andvulnerablepopulationsandthefederalhealthcaresettings,pharmacistshavesuccessfully functionedininterprofessionalpracticesettings(e.g.,IHS,VA,andDOD).Allowingpharmacists tofunctionintheseadvancedmodelsacrossmorepracticesettingsexpandsthehealthcare infrastructuretomeetdemandsforincreasedpatientcareservices. PharmacistsareremarkablyunderutilizedintheU.S.healthcaredeliverysystemgiventheir levelofeducation,training,andaccesstothecommunity.Maximizingtherolesandscopeof pharmaciststodeliveravarietyofpatientcenteredprimarycareandpublichealth,in collaborationwithphysicians,isaprovenandexistingparadigmofcarethatcanbeefficiently implemented. DuringtheApril11,2011launchofthePartnershipsforPatientsInitiative,DonaldBerwick,CMS Administrator,stated,Americaisfacingacriticalchoiceinhealthcare.Eithercutcareor improvecare.Idontliketocutcare,sotheonlyrightthingtodoisimprovecare.10Thelink betweentheimpactofmedicationsonthehealthsystemandtheexpertiseofthepharmacist, coupledwiththeexponentialgrowthincostofcare,drawsalogicalparalleltothismodelasa keystoneofcare.Oneofthemostevidencebaseddecisionstoimprovethehealthsystemis tomaximizetheexpertiseandscopeofpharmacistsandminimizeexpansionbarriersofan alreadyexistingandsuccessfulhealthcaredeliverymodel. Objectives ObtainadvocacyfromtheU.S.SurgeonGeneraltoacknowledgepharmaciststhatmanage diseasethroughmedicationuseanddeliverpatientcareservices,asanacceptedand successfulmodelofhealthcaredeliveryintheUnitedStates,basedonevidencebased outcomes,performancebaseddataandthebenefitstopatientsandotherhealthsystem consumers(physicians,administrators,payers,etc.). ObtainadvocacyfromtheU.S.SurgeonGeneraltorecognizepharmacists,whomanage diseaseanddelivermanypatientcareservices,ashealthcareproviders.Onesuchactionis advocatetoamendtheSocialSecurityActtoincludepharmacistsamonghealthcare professionalsclassifiedashealthcareproviders. ObtainadvocacyfromtheU.S.SurgeonGeneraltohavepharmacistsrecognizedbyCMSas NonPhysicianPractitionersinCMSdocuments,policies,andcompensationtables commensuratewithotherproviders,basedonthelevelofcareprovided. Advancebeyonddiscussion(andnumerousdemonstrationprojects)oftheexpandedroles ofpharmacistdeliveredpatientcareandmovetowardhealthsystemimplementation.

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INTRODUCTION The2011ReporttotheU.S.SurgeonGeneralisanupdateofapreviouslysubmittedReportin 2009tothenActingSurgeonGeneral,RADMStevenGalson.The2011Reportprovideshealth leadershipwithevidencebaseddiscussionaboutimprovingpatientandhealthsystem outcomesthroughanadditionalparadigmofhealthcaredeliveryforexpandedimplementation intheUnitedStates.The2011revision,hereinreferredtoastheReport,providesa compellingdiscussiontosupporthealthreformthroughpharmaciststhatmanagedisease throughmedicationuseanddeliverpatientcareservices,incollaborationwithotherproviders, asanacceptedandadditionalmodelofhealthcaredelivery.Timingofthisdiscussionisvitalas healthreformhasstimulatedexplorationofinnovativecareandpaymentreformmodelsthat improveaccesstocare,providequalitycare,containcosts,andaffordsafeuseofmedications andotherpertinentmedicationrelatedissues. TheReportdiscussescurrentandfuturedemandsonthehealthcaresystem,includingthe challengeofaligninghealthcarecoveragewithaccesstocare,theincreasingburdenofchronic careneeds,andprimarycareprovidershortages.Currenthealthcaredemandsprovidean opportunitytorecognizesuccessfulandexistingmodelsofhealthcaredelivery.Withinfederal healthcare,utilizingpharmacistsontheprimarycareteamtopreventandmanagedisease,and providepatientcareserviceshasbeenoneofthemostevidencebased,proven,andtime testedstrategiestomitigatesimilardemands.Federalpharmacypractice,overthepast40 years,hasincludedexpandedscopeswithincomprehensivediseasemanagement,health promotion,diseaseprevention,andothercognitiveclinicalservicessuchasmedication management. Expandingtheroleofpharmacistsissupportedbyevidencebasedoutcomesandexisting innovativemodels.Thebenefitstranslateintoimprovedconsumeroutcomesthatsupport manytenetsofhealthreformenhancedaccessandqualityofcare,costeffectivenessand patientsafety.TheReportisframedaroundfourfocuspointsthatclearlyarticulateandpresent objectivedatathatsupporttheneedforinnovativepracticemodelsthatincludepharmacistsas essentialhealthcareproviders. Basedoncurrentpracticemodels,perceptionsofpharmacistsroles,specificallyasahealth professionalexclusivelyassociatedwithdrugproductanddelivery,shouldnowincludemany additionalpatientcare,primarycare,andpublichealthservices.Itisessentialtonotethat pharmacistscurrentlyprovidemultiplelevelsofdirectandindirectpatientcareservicesina varietyofpracticesettings.Managementofdiseasethroughmedicationuseinclusiveof CollaborativeDrugTherapyManagement(CDTM),ComprehensiveMedicationManagement (CMM)orMedicationTherapyManagement(MTM),healthpromotion,patientsafety,disease prevention,carecoordination,followupcareandotherprimarypatientcareservicesare performedbypharmacistsinasimilarmannerasotherhealthcareproviders.Therationalefor thispracticemodelisthefactthatonceadiagnosisismade,patientcareservicesrelyon pharmacologicinterventionsasthemajorformoftherapy.Dataclearlysuggestthat

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medicationsarecurrentlythecornerstoneofchronicdiseasetherapy,yetourhealthcare systemcontinuestofragmentcareandrewardreactivehealthcaredeliverymodels. Pharmacistsformaleducationappropriatelypreparesthemtosuccessfullyperformclinical servicesrelatedtothepreventionandcontrolofdiseasethroughmedications.Pharmacists arealsowellpositioned(throughaccessibility,expertiseandexperience)toplayamuch largerprimarycareroleintheU.S.healthcaresystemtomeetthesedemandsandimprove healthcaredelivery(andthehealth)ofthenation. Pharmacistscurrentscopeofpracticepositionsthemtoprovidetheseservicesthrough CollaborativePracticeAgreements(CPAs)withphysiciansorwithinanycoordinatedpatient caremodelssuchasthePatientCenteredMedicalHome(PCMH). Pharmacistshavefunctionedfordecadestodeliverexpandedpatientcareservicesinmany federalsettings.Morerecently,nonfederalpharmacistsandhealthsystemshavealso embracedexpandedpatientcarerolesthroughCDTM,medicationmanagementandother publichealthinitiativessuchasimmunizations,emergency/disastercare,pointofcaretesting, smokingcessationprograms,etc.In2002,theMedicarePaymentAdvisoryCommission (MedPAC)statedthattherewasmountingevidencethatclinicalpharmacistinvolvementin managingdrugtreatmentmayreducecostsandimprovethequalityofcare.TheMedPAC votedunanimouslythattheSecretaryoftheDepartmentofHealthandHumanServicesshould assessmodelsforCollaborativeDrugTherapyManagement(CDTM)servicesinoutpatient settings.11Progresshasbeenmade;however,elevenyearslater,theprofessioncontinuesto performrequestedclinicaldutieswithoutappropriateservicesustainingrecognitionor compensation. Whilelongevityofthephysicianpharmacistcollaborativepracticemodelservesasan indicatorofsuccess,furthersupportfromkeystakeholdersisneeded.Forsystemwide improvement,mitigationofthebarriersbeginswiththebasicacknowledgementandsupportof theseexistingandsuccessfulmodelsatthehighestlevelsofhealthleadership.Aprime exampleofsupporttoimprovehealthcaredeliverywouldberecognitionanddefinitionof Pharmacists;PharmacistDeliveredPatientCareServicesintheSocialSecurityActunder Title18,PartE,Section1861.Tocontinuetoadvancethesevalueaddedservices,pharmacists mustberecognizedfortheirabilitytoprovidetheseservices.Thisincludesstatutethrough legislation,policyestablishedbytheadministration,andcommensuratecompensation mechanismssimilartootherbillablepractitionersthatprovidecomparableservices. TheroleoffederalandtheU.S.PublicHealthService(PHS)pharmacyis,andalwayshasbeen, unique.Thereisacommonacceptanceandsupportstructurewithinthefederalsystemthat recognizespharmacistsasessentialmembersofthehealthcareteamthatcanprovidespecific patientcareservices,inadditiontoexpertlymanagingdiseasethroughoptimalmedicationuse. Leveragingthisuniqueandeffectiveinterprofessionalpracticeenvironment,itisaPHS Pharmacyresponsibilitytorecommendparadigmsofcarethatwillmaximizeuseofour 12


professiontoimprovethehealthofthenation.Thesemodelsarenotnewinthefederal sector,yetournonfederalcolleaguesandnowevensomefederalpartners,arechallengedto sustainthesepharmacistdeliveredpatientcareservicesduetorestrictivepolicy,legislation andcompensationmechanisms.Thesepersistentbarriersariseduringatimeofheightened demandforaccesstocare,costeffectivepreventionandqualitycare.Coincidentally,itisalsoa timeinwhichourhealthsystemneedsinnovation. PharmacistswithinthePHS,theDepartmentofVeteransAffairs(VA),andtheDepartmentof Defense(DOD)havebeenandcontinuetobeinnovativeinestablishingsuccessfulmodelsof pharmacistdeliveredpatientcare.Withsupportfromphysiciansandotherstakeholders,they continuetodemonstratepositiveoutcomes.Thesemodelscanbeexpandedtomeetsomeof thedemandsonthecurrentandfutureU.S.healthcaresystem.ThisReportwillprovide detaileddiscussionofadvancedpharmacypracticethroughfourfocuspointsthatoffer objectivefindingstogarnerwideradvocacyandacceptanceforfurtherimplementation.As statedbythePatientCenteredPrimaryCareCollaborative,Onlywithappropriateandoptimal medicationusewillweseerealqualityofcareimproveandhealthcarecostsdecrease3 APPENDICES AppendixA:NationalClinicalPharmacySpecialist(NCPS)ProgramIn1997,theIndian HealthService(IHS)establishedanationalcredentialingsystemforIHS,Tribal,andUrban (I/T/U)pharmacistsinanefforttoassureadvancedpharmacypractitionersintheIHS displayauniformlevelofcompetency. AppendixB:OutcomesRepositorySpreadsheetEvidencebasedoutcomesthatsupport collaborativeprimarycare.Bothfederalandnonfederalsectorshavenumerousarticles, systematicreviewsandmetaanalysesofpositivepatientoutcomesthathavebeen publishedinpeerreviewedjournals.Format:Citation,Outcomes,Results/Conclusions. AppendixC:U.S.CollaborativePracticeMapFortyfour(44)offifty(50)states12addressor mentionsomeformofcollaborativepracticeand/orprotocolsbetweenphysiciansand pharmacists. AppendixD:PhysicianSurveySubstantialPHSinterprofessionalandphysiciansupport currentlyexistsforpharmacistspracticinginadvancedclinicalandprimarycareroles.

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OBJECTIVES ObtainadvocacyfromtheU.S.SurgeonGeneraltoacknowledgepharmaciststhatmanage diseasethroughmedicationuseanddeliverpatientcareservices,asanacceptedand successfulmodelofhealthcaredeliveryintheUnitedStates,basedonevidencebased outcomes,performancebaseddataandthebenefitstopatientsandotherhealthsystem consumers(physicians,administrators,payers,etc.). ObtainadvocacyfromtheU.S.SurgeonGeneraltorecognizepharmacists,whomanage diseaseanddelivermanypatientcareservices,ashealthcareproviders.Onesuchactionis advocatetoamendtheSocialSecurityActtoincludepharmacistsamonghealthcare professionalsclassifiedashealthcareproviders. ObtainadvocacyfromtheU.S.SurgeonGeneraltohavepharmacistsrecognizedbyCMSas NonPhysicianPractitionersinCMSdocuments,policies,andcompensationtables commensuratewithotherproviders,basedonthelevelofcareprovided. Advancebeyonddiscussion(andnumerousdemonstrationprojects)oftheexpandedroles ofpharmacistdeliveredpatientcareandmovetowardhealthsystemimplementation.

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DISCUSSION FocusPoint1:PharmacistsIntegratedasHealthCareProviders Onceadiagnosisismade,manypharmacistsmanagediseaseanddeliverpatientcareservices (inclusiveofpreventiveandsupportivecare)ashealthcareprovidersintheUnitedStates. Definitionsofprimarycarecharacterizeandaffirmtheseintegrateddirectandindirectpatient careroles.Successfuldeliveryoftheseservicesdemonstratesexistinginterprofessional collaborationandsupport. DefinitionsofPrimaryCare Currentpharmacypracticeisconsiderablymorediversethanwhathasbeenpreviously reportedintermsofscopeofpracticeandpracticesetting.Traditionalrolesofthepharmacist tiedsolelytomedicationproductanddeliveryhavebeengreatlyexpanded.Pharmacists evaluateandcounselpatients,providehealthmaintenanceinformation,administer immunizations(asoneofmanypublichealthfunctions),reducedrugmisadventuresthrough clinicalinterventions,respondtodisasterneeds,assumeregulatoryrolesindrugdeliveryto assuresafety,assesspatientswhoaccessthehealthsystemthroughcommunitypharmacies, andperformpointofcaretesting.Inmoreadvancedpracticesettings,pharmacistsareinvolved withprovisionofmoreexpandeddirectpatientcarethroughcomprehensivedisease management,CDTM,medicationmanagement,healthpromotion/diseaseprevention,care coordinationandfollowuppatientcare.Manyoftheseservicesaresimilarinscopeand complexitytootherprimarycareservicesdeliveredinourhealthcaresystem. Followingdiagnosis,maximizingtheexpertiseofthepharmacistisbothlogicalandcritical consideringthatthemajorityofpatientcareanddemandonthehealthcaresysteminvolves thetreatmentormaintenanceofthediagnosedconditionthroughuseofmedications. Medicationsareinvolvedin80percentofalltreatmentsandimpacteveryaspectofapatients life.3Aninordinateamountoftimeandresourcesarespentwithinthehealthsystemdelivering diseasemanagementandmonitoringofdiseasethroughselectedtherapy.Eventhrough collaborativepractice,pharmacistswithaformaleducationthatfocusontherapeuticsand managementofdiseasethroughmedicationusearewidelyunderutilized.Onceadiagnosisis made,itisundeniablethatphysicians,physicianassistants,nursepractitionersandpharmacists assumedirectpatientcareroles.Definitionsofprimarycarehelpclarifyandconfirmthe provisionofsimilarpatientcareservicesbypharmacists. TheAmericanAcademyofFamilyPhysicians(AAFP)definesprimarycareashealth promotion,diseaseprevention,healthmaintenance,counseling,patienteducation,diagnosis, andtreatmentofacuteandchronicillnessesinavarietyofhealthcaresettings.13The definitionalsostatestheprovisionofprimarycareisoftengivenbyaphysicianincollaboration withotherhealthcareprofessionalsinanatmospherewhereconsultationandreferralsare utilized.Primarycarealsopromotespatientinvolvementandcostefficiency.Theprimarycare providerisoftenthepatientsfirstpointofcontactwhenseekingmedicalcare,andisthe 15


servicethatthentakesresponsibilityforeachpatientscomprehensivecontinuinghealthcare. Structurally,primarycareteamsoftenincludephysiciansandnonphysicianhealthcare professionals.AAFPlistsnursepractitioners,physicianassistants,andsomeotherhealthcare providers,undertheumbrellaofnonphysicianprimarycareprovidersorNonPhysician Practitioners(NPPs),butitdoesnotspecificallyincludepharmacists.Yetpharmacistsare continuallyrequestedandutilizedinprovisionofpatientcareservicesandpatientcentered healthcarehomes.AAFPdoesstatethatthesenonphysicianprovidersworkincollaborative teamswiththeprimarycarephysiciantowardtheultimategoalofoptimalpatienthealth.13 Pharmacistsinadvancedpracticemodelswithphysiciandrivenprivilegeshavebeensuccessful inmanyoftheserolesasdefinedbytheAAFP. TheInstituteofMedicine(IOM)definesprimarycareasintegrated,accessiblehealthcare servicesbyclinicianswhoareaccountableforaddressingalargemajorityofpersonalhealth careneeds,butitdoesnotspecificallystatewhattypeofcliniciansprovidethiscare.Itgoeson todiscussthatservicesincludedevelopingasustainedpartnershipwithpatients,andpracticing inthecontextoffamilyandcommunity.14Moreconcisely,primarycarecanbedescribedas consistingoffourbasicattributes:access,longitudinality,comprehensivenessofcare,andcare coordination.15Itfurtherexplainsprimarycarehasbeenshowntoprovidebenefitssuchas greateraccess,betterqualityofcare,greaterfocusonprevention,earlymanagementofhealth issues,andreductionofunnecessaryspecialistcare,whichcanbeastrategytoachievecost effectiveness. Pharmacistscollaborateaspartofthisprimarycareteamtoachievetheaforementioned benefitsandcoordinatewithprimarycareproviderstominimizeunnecessarycareandutilize eachteammembertotheirutmostability.15Pharmacistsinmanysettingsprovideadditional accesstodirectpatientcare,carecoordination,comprehensivecarethroughdisease management(wheremedicationsaretheprimarymethodoftreatment),andimprovedquality ofcare. TheCareContinuumAllianceformerlytheDiseaseManagementAssociationofAmerica (DMAA)definesprimarycarethroughdiseasemanagementasasystemofcoordinated healthcareinterventionsandcommunicationsforpopulationswithconditionsinwhichpatient selfcareeffortsaresignificant.16Diseasemanagementalsoincludespreventionof exacerbationsandcomplications,withtheultimategoalofimprovingtheoverallhealthofthe patient.Componentsofdiseasemanagementincludeidentifyingeligiblepatients,following evidencebasedguidelines,utilizingcollaborativepracticemodels,encouragingpatientself managementofchronicconditions,assessing,evaluating,andmanagingoutcomes,and promotingcontinualfeedbackwithstakeholders.Stakeholdersincludethepatient,physician, healthplan,andothercareproviders.TheCareContinuumAlliancedefinitivelyrecommends thefollowingtopreventthecomplicationsofmultipleuncoordinatedproviders:allthe diseasesapatienthasaremanagedbyasinglediseasemanagementprogram.Forthepurpose ofthisReport,thePHSPharmacyprogramimpliesadefinitionofdiseasemanagementthatis

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consistentwithprimarycaremodelsandclinicalmanagementofdisease(inclusiveof medicationuseandmanagement)withlessfocusonindividualcasemanagementservices. AccordingtoallciteddefinitionsfromtheAAFP,IOM,andtheCareContinuumAlliance,and similartootherhealthcareproviders,manyofthesepatientcareservicesaredeliveredby pharmacists.Pharmacistshavebeencollaborativelymanagingdiseaseandprovidingpatient careinthismanner.However,pharmacistsaretheonlyhealthprofessionalsprovidingthislevel ofcarewhoarenotrecognizedinnationalhealthpolicyashealthcareproviders. Thefederalsectorhassupportedphysicianpharmacistcollaborationanddemonstratedthat thesedirectpatientcareservicesdeliveredbypharmacistscanimprovepatientoutcomesas wellaspromotepatientinvolvementandcostefficiency.Foroverfortyyears,pharmacistshave practicedprimarycarethroughdiseasemanagementandothercognitiveandclinicalservices.1 Inthefederalsector,thisisnotanewmodelofhealthdelivery.Thesemodelsareacceptedin thenonfederalsector;howeveruptakeandgrowthareslowedduetoinherentpolicy, legislationandcompensationbarriersdiscussedlaterintheReport. PharmacistRoles Insomesettings,throughCPAs,thepharmacistservesastheclinicalchronicdiseasemanager (inclusiveofcustomaryprivilegesofsimilarhealthcareproviders)andcanreferbacktothe physicianatscheduledintervalsforreview.Thiscantakeplacewhetherthepharmacistispart ofaprimarycareteamorasanindividualproviderofcareincollaborationwiththephysician. Pharmacistdeliveredpatientcareisbaseduponaneffective,sustainedrelationshipbetween patients,physicians,andotherhealthcarepractitioners.Thisintegratedteamapproachalso inherentlyallowsforpharmaciststofunctionwithinthepatientcenteredmedicalhome (PCMH)oranyotherpatientcenteredhealthcarehomemodel. Currently,pharmacistsdeliverpatientcareservicesinavarietyofpracticesettingsthrough CPAstomanagediseasewherebythey: Performpatientassessment(subjectiveandobjectivedataincludingphysicalassessment); Haveprescriptiveauthority(initiate,adjust,ordiscontinuetreatment)tomanagedisease throughmedicationuseanddelivercollaborativedrugtherapyormedicationmanagement; Order,interpret,andmonitorlaboratorytests; Formulateclinicalassessmentsanddeveloptherapeuticplans; Providecarecoordinationandotherhealthservicesforwellnessandpreventionofdisease; Developpartnershipswithpatientsforongoing(followup)care. Deliveryofcomprehensivecarerequirescollaborationandcommunicationofallhealthcare providers.Thisemphasizestheimportanceofpatienteducation,followup,andindividual patientownership.Althoughappropriatelyinitiatedbyaphysicianasthediagnostician,referral toacollaboratingpharmacisttodeliverpatientcareservicesforprovisionofongoingorchronic

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care,preventionofexacerbation,andimprovementofclinicaloutcomesisacceptedpracticein manyclinicalsettings.Inthiscollaborativepractice,communicationisongoingbetweenthe physician(oranotherprimarycareprovider)andthepharmacistfunctioningasahealthcare providerthatcanmanagediseasethroughmedicationuse. Thefederalinfrastructurehasprovidedpharmacypracticeaprogressiveenvironment, producingsomeoftheoldestdocumentedexamplesofsuccessfulinterprofessionalpractice throughexpandedrolesindirectpatientcare,diseasemanagement,andpublichealth. PharmacistsintheIHS,VA,andtheDODhavelongbeenrecognizedasleadersininnovative pharmacypractice.Theirenduringhistoryofphysiciansupportedcollaborativepharmacy practicemodelsclearlyvalidatesandconfirmsthesemodelsprovisionofpositivepatient focusedqualitycare.PioneerslikeDr.AllenBrands(ChiefPharmacistforIHSfrom19551981 andChiefProfessionalOfficeroftheU.S.PublicHealthServicefrom19671981)recognizedthe needforexpandedpharmacyservicesasearlyasthe1960s.Duringthattimeframe,the pharmacistsrolebegantoshiftfromadistributivefunctionofmedicationstoamoreclinical role.Fromthe1960sforward,theIHSledanationalefforttowardimprovingpatient pharmacistinteractionandeducation.17By1974,over90percentoftheIHSsiteshadoneor morepharmacistrundiseasemanagementprogramsinplace.18 ThisIHSpatientcenteredandcollaborativeapproachfacilitatedtheevolutionanddevelopment oftheIHSPharmacyStandardsofPractice,whichweredevelopedinthemid80s,formalized andpublishedin1989,andcontinuetothisday.1,19TheIHSStandardsofPracticewereinuse beforeHeplerandStrands1990articleonPharmaceuticalCarethatpopularizedmanyofthese clinicalconcepts.20ThesesixStandardsofPracticeinclude: 1. AssureAppropriatenessofDrugTherapy 2. VerificationofUnderstanding 3. AssureAvailability,PreparationandControlofMedications 4. ProvideDrugInformationandStaffEducation 5. ProvideHealthPromotionandDiseasePrevention 6. ManageTherapy/CareforSelectedPatientsinWhomDrugsarethePrincipal MethodofTreatment(inclusiveofdiseasemanagement) ThefirstfivestandardsofpracticebasicIHSpharmacyservicesalreadyincludesnon compensatedclinicalandcognitiveservices;forexample,completionofalltreatmentplan elementsofcurrentvisit(dose,interactions,adverseevents,labvalues,etc.),currentstatusof healthmaintenanceandwellnessparameters,andappropriatenessoffollowupforcurrent healthproblems.Utilizingthefullmedicalrecord(orelectronichealthrecord),pharmacists integratecarecoordinationandprovidecomprehensiveservices.Theseservicesoptimize therapeuticoutcomesandfitwellwithinthecoreconceptsofMedicationTherapy Management(MTM)underMedicarePartDdiscussedlater.Thesixthstandardofpracticewas developedtoencompassexpandedpatientcareservicesdeliveredbypharmacistsandtruly representsanadvancedpracticecommensuratewithmanyservicesfromothernonphysician practitioners. 18


Theevolutionofpharmacistsclinicalrolesinfederalpharmacyprogramswasmadepossibleby certainpracticesettingvariablesincludingfullaccesstomedicalrecords,interprofessional supportandinmostcases,theprinciplefocusonhealthoutcomes.Historically,therewasless focusonrevenuegenerationcapacityofthepracticingpharmacistintheseroles.Thefocuswas (andis)improvedhealthcaredeliveryandoutcomes.However,becauseofthedemandfor services,acceptanceofpharmacistsinprescriptiverolesbyphysicians,willingnessoftheentire systemtoworkcollaborativelywithpharmacistsintheseinnovativeroles,andpositivepatient outcomes,programswerecontinued.Itisnotsurprisingthatexpandedclinicalpracticeroles occurredfirstinfederalagenciesliketheIHS,VA,andtheDODduetotheseandothervariables thatsupportedinnovation.Infact,inthe1970s,theIHShadalreadydevelopedand implementedwhattheIOMproposedinitsconsensusreportfrom2009regardingnational directivestodeliverinterdisciplinaryhealthcare.14Additionalexamplesofclinicalpharmacy practiceintheVAdatebackto1995andcanbediscussedinsimilarcontexts.21Throughthe 1980sand1990s,IHSpharmacistscontinuedtoprovideAmericanIndiansandAlaskaNatives, primarilylocatedinruralandunderservedcommunities,withadvancedpharmacypractices thatimprovedpatientcareandincreasedaccesstovitalprimarycareservices,disease management,andpreventionservices.Implementingasimilarparadigmofhealthcaredelivery utilizingpharmacistsmaylessentheimpendingchallengesofhealthreformsuchasaccessto care,particularlywithmedicallyunderservedandvulnerablepopulations. InterprofessionalCollaborationandSupport Substantialinterprofessionalsupport(fromphysicians,otherNPPs,andadministrators)exists forpharmacistspracticingasprovidersinexpandedclinicalroles.GeorgeHalvorson,chairman andCEOofKaiserFoundationHealthPlan,Inc.andauthorofHealthCareReformNow!:A PrescriptionforChange,gavethekeynoteaddressatthe2009HealthcareInformationand ManagementSystemsSociety(HIMSS)AnnualConferenceandExhibition.Whilespeakingon thesubjectofmuchneededhealthreform,Halvorsondeclaredthatclinicalpharmacistsare themostunderutilizedmembersofthehealthcareteam.22Expandedpharmacistdelivered patientcarecanbeanessentialcomponentofanycollaborativecaremodel.Thevarious servicesareeasilyintegratedintoCPAsthatfurtherdefinepharmacistsclinicalprivilegesand patientcareservices.TheseservicescanbedeliveredviathePCMHmodel,disease management,CDTM,oranyothertypeofpatientcareservice. Healthreformcallsforanintegratedworkforcethatutilizestheskillsetsofhealthcare professionalsacrossdisciplines.22,23Turfissuesareageoldbarrierstointerprofessional practicethatdonotsupportanytypeofsuccessfulhealthreform.However,inmanypractice settings,theturfissueismoreamyththatneedstobedispelledthananactualbarrier. Collaborativepracticecurrentlyexistsinternalandexternaltothefederalpharmacysector.In additiontothefederalpracticesetting,CPAsbetweenphysiciansandpharmacistsaredirectly authorizedby44statepharmacyboards.12

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AppendixCdisplaysamapofstatesthatlegislativelysupportcollaborativepracticebetween pharmacistsandphysicians.Itisimportanttonote,however,thatbecausenuancesexist betweentheterms"CDTM"and"CPA",interpretationscanvary.CDTMtendstodefinethe processbywhichapharmacistmayadjusttherapyandmanagemedicationuse.CDTMand CDTMagreementsarespecifictomedicationuseandmanagement.However,CPAsmayallow additionalflexibilityforboththephysicianandpharmacisttoprovidemorecomprehensive primarycareandpatientservices,suchascarecoordination,diseasemanagement,disease prevention,andfollowupcare.Thisaddedflexibilityhelpsphysicianstobettermeetthe diverseandwiderangingneedsofindividualpatientsandpracticesettings. Asdiscussed,44statesallowforsomeformofcollaborativepractice,whichmeansthatthe individualstatepharmacylawsallowpharmaciststoinitiate,modify,and/ordiscontinuedrug therapypursuanttoacollaborativepracticeagreementorprotocol.12Whilethisdefinitionis veryclosetothepharmacyassociationsconsensualtermCDTM,24somestatesspecifically addressCDTMintheirstatepracticeactsandothersdonot.Asamatteroffact,afewstates addresscollaborativeprivilegestopharmacistsundertheirmedicalacts.Anotherexampleof suchinconsistencyiswhenonestateallowscollaborativepractice,butitislimitedby restrictingdrugtherapymanagementtoasetting(e.g.,hospitalsonly)oradrugclass(e.g.,oral contraceptivesonlyinMaine).InMay2011,thegovernorsofNewYorksignedlegislationto expandCDTMtoteachinghospitals,movingtheEmpirestatefromaPendingstatuswiththe NationalAssociationofBoardsofPharmacytoYeswithregardstoCDTM.Thislegislation increasedthenumberofcollaborativepracticestatesto44in2011eventhoughCDTMwas alreadyapprovedatnonteachinghospitalsinNewYork.12Thesestatistics,however,dont trulyrepresenttheextentofCDTMsincetheremainingsixstatesdonotaddresscollaborative practicebutdocumentationinpharmacyjournalsshowsthatitexists.Thisambiguityhaspros andcons.Withoutspecificregulationsorguidance,statepharmacyboardscanhavemore flexibilitytoregulateCDTM,prohibitthepracticecompletely,orallowcollaborationdefactoif nooneobjects. In2008,apioneeringeffortwasundertakenbytheNationalClinicalPharmacySpecialist(NCPS) ProgramwithintheU.S.PublicHealthServicetoilluminatephysicianpharmacistcollaboration througharespondentdrivensurveyandhelpdispelsomeofthemythsofnonsupport.The NCPSProgram,whichnowextendsbeyondtheIHSandintotheBureauofPrisons(BOP),has beensuccessfulwithphysicians,medicalstaffs,andotherstakeholdercollaborationsfor13 years.Theprogramensuresconsistencyandqualityofprimarycareforpatientstreatedand managedbyNCPSpharmacists.Withinmostliteraturereviews,thecustomaryapproachisto havepharmacistsattesttothesupporttheyhavereceivedfromphysician.However,attestation anddatacollectedfromphysicianonlyperspectivesismuchlesscommon.Toovercomethis datagap,theNCPSProgramdevelopedarespondentdrivensurveytoseektheinputofIHS physiciansontheclinicalandadministrativeimpactofpharmacistsdeliveringprimarycare servicesincludingdiseasemanagement.Physicianrespondentsupportofthisparadigmof healthcaredeliverywasdecisive: 20


Demographics 117Physiciansrepresenting13statesand33IHSandTribalfacilitiesresponded. 100%ofthedatacollectedcamefromphysiciansinfacilitiesthathavepharmacists practicingundercollaborativepracticeagreements(CPAs). 87.2%oftheproviderssurveyedhaveworkedorarecurrentlyworkingwitha pharmacistwhowasrecognizedasaNCPS.Asdiscussed,theNCPSProgramhelpsto assureastandardizedscopethatincludesspecificprescriptiveauthority,laboratory authorityandsomephysicalassessmentprivileges. Results 96%ofphysicianswhorespondedreportedsomebenefits,includingimproved diseasemanagementoutcomes,increasedreturnoninvestment,allowingthe physiciantoshifttheirworkloadtomorecriticalpatients,increasedpatientaccess tocareandmore. 76.8%ofphysicianssurveyedagreedorstronglyagreedthatfromtheir experiences,theservicesprovidedbypharmacistsprovideadequateevidenceto recognizethemasbillablenonphysicianpractitioners. 85.2%ofphysicianssurveyedagreedorstronglyagreedthatNCPScertified pharmacistshaveadequateknowledge/trainingtoprovideclinicalservices. 71.6%ofphysiciansfeltthatclinicalservicessuchasdiseasemanagementprovided bypharmacistsarenecessarytooptimizepatientcare. 88%ofphysiciansfeltthiscollaborativepracticewithpharmacistsintheirfacilities hasimprovedoverallprimarypatientcare. AmorecomprehensivesummaryoffindingscanbefoundinAppendixD.Giventheseresults,it istheperspectiveofphysicianrespondentswithinthissurveythatthepositiveoutcomesof pharmacistsdeliveringprimarycareserviceswithappropriateprivilegesfromthephysician ormedicalstaffareundeniable.FederalandPHSPharmacyhavebeenawareofthissupport formanyyears.Collectingdatafromphysiciansdirectlyinvolvedinthismodelofhealthcare deliveryshouldhelpdispelsomeofthemisperceptionsofcollaborationanddemonstratethe substantialamountofpositivepatientandhealthsystemoutcomes. Collaborationbetweenthepharmacistandphysicianalsoprovidesthepatientwithhigher quality,safer,andmorecomprehensivehealthcareviatheteamapproach.Pharmacistsare uniquelyqualifiedtoprovideadditionalpatientcareservicesthroughthesecollaborativeand synergisticeffortsthatcomplimentphysicianservices.Advancedpracticepharmacymodels benefitmanyconsumers,includingotherprimarycareproviders,patients,andadministrators. Themodelsalsoprovidebenefittothirdpartypayersintheformofpreventivecare,quality care,patientsafetyandcostcontainment.Othercountriesarealsoworkingtowardintegrating thepharmacistintotheprimarycaresetting.InCanada,theIMPACTstudyhasplaced pharmacistsatprimarycaresitesinOntario,Canadawithpromisingresults.25IntheUnited Kingdom,PharmacyinEngland:buildingonstrengthsdeliveringthefuture,proposesa modelthatinvolvesthepharmacistinthecommunitysetting,aswellasschools,carehomes, prisons,healthcenters,andgeneralpracticesettings.26IntheUnitedStates,specificallyin federalpharmacy,thisintegrationhasbeeninplacefordecades. 21

In1997,conclusionsreachedbytheMedPACstatedthatingeneral,physicianssupportthe conceptofcollaborativedrugmanagement,11suggestingthatongoinginvolvementwould needtobeclearlydefined.Duringthisdiscussion,theAmericanCollegeofClinicalPharmacy (ACCP)offeredthatintheserelationships,thephysicianwoulddiagnosethepatientanddecide uponinitialtreatment.Thephysicianwouldthenauthorizethepharmacisttoselect,monitor, modifyanddiscontinuemedicationsasnecessary.11Inthefederalpharmacysector,both conceptswerealreadyappliedinpractice.Asseenoverthelastdecade,supportwasevidentin thenonfederalsector,yetlessthanoptimal.Morerecently,however,aneditorialintheAJHP notedthatanumberofmedicalsocietygroupshaveconcludedhavingpharmacistsworking directlywiththemiscritical.ExamplescitedincludedTheSocietyofCriticalCareMedicine,the InfectiousDiseasesSocietyofAmerica,andtheNationalAssociationofEpilepsyCenters.27 Fromanacademicperspective,theAmericanAssociationofCollegesofPharmacy(AACP) annuallyconvenesanArgusCommissioncomprisedofthefiveimmediatepastAACP presidents.The20092010Commissionexaminedthepharmacistscontributiontoprimary healthcaredeliveryinthecontextofnationalhealthcarereform.TheCommissionsPresident subsequentlyinvitedrepresentativesfromeducationassociationsofvariousdisciplines recognizedasprimaryhealthcareproviders.Thisincludedprovidersandrepresentativesfrom: AmericanDentalEducationAssociation AssociationofAmericanMedicalColleges PhysicianAssistantEducationAssociation EmoryUniversitySchoolofMedicine AmericanAssociationofCollegesofNursing SchoolofMedicineandHealthSciences,TheGeorgeWashingtonUniversity AssociationofSchoolsofPublicHealth AssociationofAmericanCollegesofOsteopathicMedicine Twodistinctfindingsresulted:1)Allparticipantsagreedthatmedicationusefactorswere importantelementsofqualityprimarycare,includingpatienteducation,monitoring,andsafety considerations,and2)Allofthedisciplinesrepresentedembracedinterprofessionaleducation (IPE)andpractice,andspecificallyrecognizedtheimportanceofIPEinaddressingdeficiencies inthechroniccarepatientmanagementmodel.28 Morerecently,aneditorialwasreleasedfromtheChairoftheAmericanMedicalAssociation BoardofTrustees,Dr.ArdisDeeHoven.TheeditorialdiscussedDoctorpharmacistteamwork thatcanapplytomanysettings.Itrecognizedthatcollaborativedrugtherapymanagementcan beapositiveandpowerfulwaytoenhancepatientcareandreducecosts.Italsonotedthat successfulcollaborationsalreadyexist.29Thiswasapositivestepintherightdirectionwithour largestandmostrenownedmedicalsociety.Thisdiscussioncontinuesandhasinvolvedthe pharmacyprofessionslargestorganization,theAmericanPharmacistsAssociation(APhA).

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FocusPoint2:RecognitionasHealthCareProviders Pharmaciststhatdeliverpatientcareservices,includingmanagementofdiseasethrough medicationuse,shouldberecognizedashealthcareprovidersandpractitionersasdefinedin theSocialSecurityActandotherhealthlegislationandpolicy. AdvancedPharmacyPracticeModels Insomestates,pharmacistsarerecognizedfortheirexpandedservices,inpolicyand privileging,throughCPAs,orothercollaborativepracticearrangementsandinrarecases, throughlicensureasclinicians.Althoughseparatelicensureforpharmacistsintheserolesis notnecessarilyneeded,currentrecognitionbysomestatesreflectsaprecedentthatprimary careservices(postdiagnosis)aresuccessfullydeliveredwithinthecurrentscopeofpharmacy practicethroughCPAs.Withthislevelofstaterecognition,pharmacistdeliveredpatientcare hasthepotentialtobesustainedthroughcommensuratecompensationandsupport.For example,someprogressivestateMedicaidprograms(NewMexico,Arizona,SouthDakota,and Minnesota)haverecognizedthebenefitsofthesepharmacistservicesandalreadycompensate pharmacistsforhealthcareservicesmorecommensuratewithothernonphysician practitionersviafeeforserviceormorefrequentlyasaflatratefee.Eveninpractice environmentswithoutfiscalbarriers,thistypeofrecognitionandscope,reflectiveof pharmacistdelivereddirectpatientcare,allowsforadvancedpracticemodelstoflourishand obtaingreatersupportfromcolleaguesandadministrators. DiscussionoftheIHSpharmacypracticemodeloffersanappropriateexample.Inresponseto years(19701995)ofIHSmedicalstaffsupportofadvancedpharmacypractice,formerIHS DirectorMichaelTrujillo,MD,MS,MPHreleasedaSpecialGeneralMemorandum(SGM962) in1996.ThisgroundbreakingdocumentrecognizedClinicalPharmacySpecialists(CPSs)as primarycareproviderswithprescribingauthority.30In1997,representativesfromtheIHS pharmacyprogramandleadersfromtheHealthCareFinancingAdministration(HCFA), renamedCentersforMedicare&MedicaidServices(CMS)in2001,discussedtherecognitionof pharmacistsasprimarycareproviders.31Therewaslittledisagreementabouttheexpanded scopesandlevelsofserviceprovided.However,arecommendationwasmadebyCMSto developauniformandnationalcredentialingprogramthatwouldassureconsistencyand qualityofcareforpatientstreatedormanagedbypharmacistsintheIHS.TheIHSpromptly respondedtotherecommendationmadebyCMSwiththedevelopmentoftheNCPSin1997.31 ThroughCPAs,manyIHSpharmacistsdeliverdirectpatientcarethroughdiseasemanagement including,butnotlimitedto,anticoagulation,dyslipidemia,congestiveheartfailure,coronary arterydisease,diabetes,asthma,hypertension,endstagerenaldisease,painmanagement,and tobaccocessation.31Theyareuniquelyqualifiedasexpertsindrugtherapyandcurrently functionwithexpandedscopesinmanysettingswheretheyperformphysicalassessment,have prescriptiveandlaboratoryauthority,formulateclinicalassessments,developtherapeutic plans,providepatienteducation,carecoordination,andfollowupcare,managebothacute andchronicdisease,andprovidemanyothercognitiveclinicalservices. 23


Thesepatientcareservicesaredeliveredbypharmacistsonceaninitialdiagnosisismade, whichissimilartothoseservicesprovidedbyotherprimarycareprovidersandnonphysician practitioners.Overthelast13years,278IHSpharmacistshavebeencertifiedbytheNCPS Program.Currently,thereare179activelypracticingNPCSpharmaciststhatareincreasing accesstocareandimprovingqualityofcareinover41sitesand16states.Tobecome privilegedataparticularsitewithintheIHS,alocalmedicalstaffandphysicianmustobserve andattestthatthepharmacistisacompetenthealthcareprovider.Thisassuresoversightand isaphysiciandrivenandlocalprivilegingmechanism.ACPAisdevelopedbetweenthemedical staffandtheNCPSpharmacist.TheCPAidentifiesthescopeofmedicalconditionstheNCPS pharmacistisprivilegedtomanageoncethediagnosisismade.Pharmacists,asdemonstrated laterinthisReport,havebeenabletoimproveconsumeroutcomesincludingclinical, administrative(i.e.,increasephysiciantimeformorecriticalcareandincreasedpatientaccess tocare),andcosteffectiveness.Thus,pharmacistsintheseclinicsperformdirectpatientcare servicesanddocumentthefindingssimilartoanyotherhealthcareprovider,butwith recognitionandrevenuegenerationcapacityonlyinalimitednumberofstates. Administrativebarriersincreasethepotentialthatpatientswillnotbeabletoaccessprimary careservices.Forexample,accesstohealthcaredeliveryforamedicallyunderserved populationmaybedirectlyimpacted.Insomepracticesettings,pharmacistdeliveredcaremay betheonlycareavailableasidefromwaitinglistsforappointmentswithoverburdened primarycarestaff. TheHealthResourcesandServicesAdministration(HRSA)alsostronglysupportstheroleofthe pharmacistandtheprovisionofpharmacyservicestopatientswithmultiplechronicconditions throughaninterprofessionalteam.In2008,theSenateAppropriationsCommitteeReport encouragesHRSAtoestablishapharmacycollaborativetoidentifyandimplementbest practices,whichmayimprovepatientcarebyestablishingthepharmacistasanintegralpartof apatientcentered,interprofessionalhealthcareteam.32HRSAbeganitsworkbystudyingthe leadingpracticesinpatientsafety,clinicalpharmacyservicesandhealthoutcomesidentifiedin organizationsfoundtobeearlyadaptersacrossthenation.33Inadditiontomanyofthehigh performingsitesinthesafetynetsetting,HRSAalsoutilizedandcompiledthedecadesof experienceandleadingpracticesestablishedbytheIHSadvancedpharmacypracticemodels. TheseIHSmodelscanassisthealthsystems,clinics,andcommunitieslearn,replicate,test,and adoptthesepracticestoimprovehealthoutcomesandreduceadversedrugevents.InOctober 2007,HRSAplannedandimplementedthePatientSafetyandClinicalPharmacyServices Collaborative(PSPC),whereteamsofhealthcareproviders,includingHRSAsupportedentities andtheirpartnersfromcommunitiesacrossthenation,areworkingtotransformthedelivery ofpatientcare.Usingapatientcenteredapproach,theteamsintegratedevidencebased clinicalpharmacyservicesintothecareandmanagementofhighrisk,highcost,complex patients.Currently,themostsuccessfulteamsinvolvecliniciansfrommultipledisciplines, togetherwiththeirorganizationsleaders,understanding,growing,andtrackingtheimpactsof clinicalpharmacyservices.Thisintegratedinterprofessionalapproachisrevisingtraditional healthcareteamrolesandbothmaximizesandleveragestheexpertiseoftheentireteamso thepatientreceivesthebestqualitycare.BasedondatacollectedfromPSPCteams,54percent ofpatientsonceidentifiedasoutofcontrolornotoptimallymedicallymanaged,arenow 24


undercontrolacrossarangeofchronicconditionsusingstandardizedmeasures.Also, adversedrugevents(ADEs)oractualeventsthatcausepatientharmhavefallenbyanaverage of49percentforthishighriskpatientpopulation.Initsthirdyear,thePSPChasexpandedto 127communitybasedteamsin43states.33Teamscontinuetherapidspreadofleading practicesfoundtoimprovepatientsafetyandhealthoutcomesmosteffectivelyinahealth homemodel.Yearthreewillworktoexpandandspreadtolargerpatientpopulationsthatneed thistransformationdeliverysystem. Outsidethefederalsector,therearesomeprogressivemodelsthathavedeveloped,asnotedin NewMexicoandNorthCarolina.Inbothstates,pharmacistspracticinginadvancedclinical scopesarerecognizedmorebroadlythroughpolicy,legislation,andevenlicensure. Additionally,bothstateshaveidentifiedanadvancedscopeofpracticethroughCPAsand compensatesimilarlyforaprimarycarevisit.NewMexicosPharmacistClinician(PhC)program hasdevelopedanappropriatecompensationmechanismthroughitsstateMedicaidprocess. ThiswillbediscussedinmoredetailwithinFocusPoint3. InNorthCarolina,theClinicalPharmacistPractitionerActbecameeffectiveJuly1,2000and openedthedoorforcollaborativepracticeopportunities.Thissuccessfulimplementationof legislationacknowledgedtheimportanceofpharmacistsandcollaborativepractice.Thestate ofNorthCarolinahasofferedcredentialstopharmacistswhowishtobecomeaClinical PharmacistPractitioner(CPP).Inthismodel,ifthepharmacistmeetscertainqualifications,he orsheisapprovedbytheMedicalandPharmacyBoardsofNorthCarolinaasaCPP,andis assignedaprovideridentificationnumber.34Requiredcredentials,inadditiontoaNorth Carolinapharmacistlicenseandagreementwithsupervisingphysician,includeoneofthe following:1)certification(eitherfromtheBoardofPharmacySpecialties,orisaCertified GeriatricPharmacist)oranAmericanSocietyofHealthSystemPharmacists(ASHP)Residency includingtwoyearsofclinicalexperience,or2)aDoctorofPharmacy(PharmD)degreewith threeyearsofexperience,pluscompletionofoneNorthCarolinaCenterforPharmaceutical Care(NCCPC)orAccreditationCouncilforPharmacyEducation(ACPE)approvedCertificate Programs,or3)aBachelorofScience(BS)degreewithfiveyearsofexperience,pluscompletion oftwocertificateprogramsfromNCCPCorACPE.34,35NorthCarolinasexampleofcertification qualificationsoffersneededflexibilitywithintheprofession.Thisisimportantbecausemany differentpathsarriveatthesameplaceclinicalcompetence.Thisflexibilityisalsoseeninthe NewMexicoPhCprogram.Oncecredentialed,aNorthCarolinaCPPisabletoorder,change,or substitutetherapies,andorderlaboratorytests,whileunderthepurviewofaCPAwitha licensedphysician.36CPAsarekeptbroadandgeneralizedtoallowchoiceoftherapybased onindividualpatients,andalsoincludeaplanforaweeklyqualitycontrolmeetingbetween theCPPandsupervisingphysician.Inthesemeetings,thephysicianreviewsthepharmacists orders.35

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PharmacyEducationandTraining Becausepharmacypracticehasalreadyshiftedtoallowmoreclinicalservices,thenations collegesandschoolsofpharmacyhavefollowedsuitwithappropriateeducationandtrainingto supporttheseroles.Theentryleveldegree,whichhasbeenelevatedfromaBSinPharmacyto aDoctorofPharmacy,requiresadditionalyearsoftraining.Thishasincreasedovertheyears fromfouryearsoftrainingtofive,andnowtoaminimumofsixyears.Thecorecurriculum includespathophysiology,pharmacology,therapeutics,clinicalproblemsolving,laboratory monitoring,andphysicalassessmentskillsformanydiseases.Studentpharmacistsarerequired tocompletehospitalroundswithmedicalstudentsandphysicians.Thelatestcurricular guidelinesfromtheAccreditationCouncilforPharmacyEducation(ACPE)alsomandateearly pharmacypracticeexperiencetraining/shadowinginaphysiciansofficeandclinicalhospital settinginordertoexposestudentpharmaciststoacollaborativepracticeenvironmentandgive theminsightintotheresponsibilitiesanddecisionmakingskillsthatphysiciansperformdaily.37 Mostuniversitiesthathavebothmedicalandpharmacycollegeshavebuiltinterprofessional practiceintothecurriculumandteachbothprofessionsstudentstogethertoprovidepatient care.Pharmacistsyearsofeducationandleveloftrainingisalignedwiththatofdentistsand surpasses,inmanyexamples,theamountofeducationandtrainingrequiredofothernon physicianpractitioners. AllpharmacyschoolgraduatesarerequiredtotaketheNorthAmericanPharmacistLicensure Examination(NAPLEX),anational,comprehensive,andstandardizedboardexam.Havinga standardizedlicensingexamensuresthatallpharmacygraduatesareheldtohighanduniform expectations. Postgraduatetrainingisencouragedthroughouttheprofession,includingfirstandsecondyear residencies,fellowships,Master,andDoctoralleveltraining.Residenciesareonetotwoyears inlengthandareaccreditedbytheAmericanSocietyofHealthSystemPharmacists(ASHP). Pharmacyresidencyprograms,bothinhospitalsandinthecommunity,servetofocusanew pharmacistsskillsforspecializationinthemanagementofaspecificormultiplediseasestates. Residencytrainingishandson,multidisciplinary,andclinicallycomprehensive.TheVAhasa robustresidencyprogramwithapproximately159sites.TheIHSoffers18progressivepractice residencysitesandiscurrentlygraduatingapproximatelytwentytworesidentpharmacistsa year.TheBureauofPrisonscurrentlyhasoneresidencysite. Clinicalspecialtycertificationsarewidelyavailableforpharmacists.Pharmacistsmaybecome boardcertifiedbytheBoardofPharmacySpecialties(BPS)asapharmacotherapyspecialist (BCPS),nuclearpharmacist(BCNP),nutritionsupportpharmacist(BCNSP),oncologypharmacist (BCOP),psychiatricpharmacist(BCPP),orambulatorycarepharmacist(BCACP).BPSregulates applicanteligibilityandcontentoftheexamination.38AlthoughBPSdesignationsaregrantedto individualswhopasstheexamination,thisboardcertificationisnotrequiredofpharmacists. Thesedesignationsarenotanalogoustotheboardspecialtyexaminationsthatphysiciansare requiredtopassforspecialtylicensure. 26


AnotherspecialtycertificationavailabletopharmacistsistheCertifiedGeriatricPharmacist (CGP),establishedbytheAmericanSocietyofConsultantPharmacists.31Additional certificationsthatpharmacistsmaypursueincludeCertifiedDiabetesEducator(CDE),Board CertifiedAdvancedDiabetesManagement(BCADM),InfectionControlProfessional(ICP),a CertifiedProfessionalinHealthcareQuality(CPHQ),aCertifiedProfessionalinHealthcare InformationandManagementSystems(CPHIMS)andaChronicCareProfessional(CCP).39 ThisReport,whilesupportiveoftheBPSandothercredentials,recognizesthatcertaintypesof credentialsbeyondtheNAPLEXshouldnotlimittheprofessionalscopeofpharmacy.The Reportalsocommunicates(asdiscussedundertheNewMexicoandNorthCarolinamodels) thatwiththeexceptionoftheNAPLEX,flexibilityofadvancedpracticepharmacistqualifications isnecessarytoensurecompetence.TheBPSandothercredentialingprogramsrequire satisfactorycompletionofathoroughexam;theydonotrequiredirectobservationof competencebymedicalpersonnel.Directobservationofcompetencehowever,canberequired withinacollaborativepracticeagreement(CPA)inordertogainlocalmedicalprivileges.Each practiceenvironmentshouldconsiderwhatcombinationofcredentials,training,and experienceismostappropriate,yetremainflexibletoallowforallqualifiedandcompetent pharmaciststheopportunitytoimproveoutcomes.Currenttrainingandeducationaftersix yearsoffocusedstudyontherapeuticsandrelatedtopics,thesubsequentNAPLEXexam,and competencybasedexperiencehaveproventobebothadequateandsuccessful,andare supportedthroughdecadesofcollaborativephysicianpharmacistpractice. Pharmacistsundergoaverysimilarlevelofeducationcomparedtoothernonphysician practitioners.Inallpharmacyschoolcurricula,apharmacistwillneedaminimumofsixyearsto completethedidacticeducationportion,notincludingaresidency.PhysicianAssistants(PA) educationalprogramsconsistofeitherafiveyearcombinationbachelors/mastersdegree,ora fulltimetwoyearprofessionalprogramafterthecompletionofabachelorsdegreewith appropriateprerequisites.40NursePractitioners(NP)mustfirstbecomearegisterednurse (throughabachelors,associates,ordiplomaprogram),whichcanbeaccomplishedinunder fouryears,andthencompleteamastersprogramtoobtainpractitionercertification,including atwoyearcourseoffulltimestudy.41BothPAsandNPsaretrainedtoperformphysical examination,diagnosemedicalconditions,andinmoststates,prescribemedicationstotreat theirpatients.Bothoftheseprofessionaltypesalsofocusonpatienteducationanddisease prevention.40,41Inbothcases,thesehighlyskilled,recognized,andappropriatelycompensated healthcareprovidershavethesameamountandsimilartypeofeducationaspharmacists. ComparedtoPAsandNPs,theeducationalpreparationofpharmacistsemphasizespatient assessmentandtherapeuticmonitoring,whichestablishespharmacistsexpertiseinthe comprehensivemanagementofdiseasethroughmedicationuse.Theemphasisondrugtherapy inthepharmacycurriculumisinextricablylinkedtoprovidingqualitycaresubsequenttoa diagnosis.Pharmacyschoolcurriculaalsoincludediagnosticandphysicalassessment courseworkaswell.AsdiscussedinFocusPoint1,onceadiagnosisismade,especiallyinthe caseofchronicdisease,mostofpatientcare(upto80percent)isgearedtomanagementof diseasethroughdrugtherapy.Consideringthesepatientcareneeds,thepharmacistisuniquely 27


qualifiedtocomplimentthediagnosticians,suchasphysicians,toprovidecomprehensivecare. OtherNPPssimilarlytakeonrolesthatprovidevaluerelatedtotheirexpertise.Itisalsoagood exampleofhowhealthreformimplementationcanmaximizetheskillsetsofhealthcare professionalsacrossdisciplines.23Theamountofeducationortrainingapharmacistcompletes shouldnotbechallengedinthisdiscussion.Rather,themostpressingchallengeistofacilitate consumerunderstandingoftheprovenadvantageofhavingpharmacistsinvolvedinthe deliveryofhealthcareincludingprovisionofqualityprimarycaretomeethealthsystem demand.Thoseconsumersincludelegislators,administrators,healthleadership,insurers,and otherthirdpartypayers. Thefederalsectorisnottheonlysystemthatsupportspharmacistsinadvancedpractices. AlthoughNewMexicoandNorthCarolinawerementionedashavingspecificprogramswith advancedpractices,fortyfour(44)states(asofMay2011)acrosstheUnitedStatessupport collaborativedrugtherapymanagement(CDTM)intheirBoardofPharmacypolicyorby laws.12,42Thisisencouragingasitdemonstratesthatpharmacistsaresupportedbytheirstate boardsandthatperformingtheseexpandedclinicalduties(respectiveofeachstatepolicy)is withintheirlegalscopeofpractice.Thesecollaborativepracticesrangefromimmunizations,to medicationtherapymanagement,todiseasemanagementwithprivilegesincludingprescriptive andlaboratoryauthority. Asanotherexample,healthcareprovidersaregenerallyseenashavingprescriptiveauthority. MuchlikepharmacistsintheIHSandVA,agrowingnumberofstates(suchasNewMexico, NorthCarolina,andMassachusetts)alreadyallowforprescriptiveauthoritytopharmacists throughcollaborativepractice.InFebruary2011,theDrugEnforcementAdministration(DEA) grantedprescribernumberstopharmacistsinMassachusetts(1of7states).43Thisimportant recognitionofpharmacistsasmidlevelpractitionersallowspharmacistsworkingunderCDTM agreementstoprescribecontrolledsubstances. Theexistingrolesofpharmacistsandtheircurrentdeliveryofpatientcareinmultiplesettings basedonhealthsystemdemandsnecessitatesfurtherevolutionoflegislationandpolicy. Recognitionofpharmacistsprovisionofadditionallevelsofpatientcarethroughlegislation andpolicywillpromotethesupportneeded(increasedprivatesectorresponseandadequate compensationmechanisms)tofullysustainthesevalueaddedservicesthatareprovento improvepatientoutcomesandhealthcaredelivery. IntheAffordableCareAct(ACA),thereareseveralreferencestopharmacistsaspartofa healthteam(Section3502),andpharmacistdeliveredandpharmacistprovidedservices (Section3503).Inaddition,Section3503authorizesMedicationManagementServicesin TreatmentofChronicDiseasetobeprovidedbylicensedpharmacistsasacollaborative, multidisciplinary,interprofessionalapproach.23RecognizingPharmacists(Pharmacist DeliveredPatientCareServices)intheSocialSecurityActashealthcareprovidersisthe appropriateevolutionoflegislationthatwillexpandtheutilityandeligibilityofpharmacists tobetteraddressthenationshealthcaredemands,andimprovepatientandhealthsystem outcomes. 28


FocusPoint3:CompensationMechanisms

Currentcompensationmechanismsforpharmacistsinadvancedpracticerolesneedtoexpand andreflectthelevelofpatientcareservicesprovided.Thelackofcompensationmechanismsis acurrentbarrierforoptimalhealthsystemoutcomes,andtheexpansionandsustainabilityof pharmacistinvolvement. EssentialforSustainability Snella,etal.suggeststhatcompensation,ratherthanreimbursement,isthepropertermto applytothepaymentofpharmacistswhoarerecognizedashealthcareproviders. Compensationreferstopaymentforaservicethatreflectsbothreimbursementforthecostof anitemorserviceandthevalueaddedbytheprovider.44Pharmacistsfunctioningashealth careprovidersperformcognitivepatientcareservicesthataddvaluetothepatientscare.The currentreimbursementmodelindicatesthatpharmacistsshouldonlybepaidforadrug productordevice,withlittleornopaymentforthecognitiveandvalueaddedportionofthe service. Atthe2008WorldHealthCareCongress,healthstakeholdersrecognizedthataligning reimbursementwiththequalityofcareisexpectedtodrasticallyimprovethehealthcare systemasawhole.45Thissuggestsaperformancebasedcompensation.FocusPoint4illustrates hundredsofevidencebasedoutcomeswithinmanydifferentadvancedpharmacypractice models.Thesemodelsdemonstratethatafterrigorouscollectionandanalysisofdatawithin theappropriatepracticeenvironment,includingexpandedpharmacistprivileges,outcomes improve.Pharmacistswhodemonstratepositivepatientandhealthsystemoutcomes,and performalevelofcarewithsimilarimpacttoNursePractitioners,PhysicianAssistants,or Physiciansneedtobeequallycompensated.Improvedparityincompensationforpharmacists providingsimilarlevelsofcarethroughdiseasemanagementorotherpatientcareservicesis imperativeifthesevaluableandsoughtafterresourcesaretocontinue. Inboththepublicandprivatesectors,healthsystemsarechallengedtosustainanyclinical servicewithouttheabilitytogeneraterevenuefromtheserviceprovided.Although pharmacistsdoplayalargerpatientcareroleinmanyfederalsettings,sustainabilityis threatenedbythelackofcommensuratecompensation. Asanexample,federalfundingfortheIHSfallsbelowthemainstreamhealthplanannually. Becauseofthiscontinualresourcedisparitygap,fiscalappropriationfortheIHSnow necessitatesrevenuegenerationfromMedicaid,Medicare,andotherthirdpartypayers. Consequently,manyprogressivepracticesettingsarefastapproachingacrossroadsandmust decidewhethertocontinuevalueaddedservicesthathavebeenprovidedwithout compensationandpotentialrevenuegeneration,ordiscontinuethem,furtherescalating problemswithaccess,quality,andcosteffectiveness.TheIHScontinuestodemonstrate successfuladvancedpharmacypracticemodelsinmanystates.However,stateswhere pharmacistscangenerateadditionalrevenuethroughMedicaidprogramsgreatlyassistin 29


sustainingtheseservices.Thesestateseitherrecognizepharmacistsashealthcareprovidersfor clinicalservicestoMedicaidrecipients(NewMexicoandNorthCarolina)orprovideadditional compensationforcognitivepharmacistservices(Arizona,Minnesota,SouthDakota).However, thelevelandconsistencyofcompensationvarygreatly.Thesevariationsmaybesignificant enoughtocreateadisparityofhealthcareservicesofferedtocertainstatepopulationswitha needforahealthcarehomeorwithotherhealthinequities. HRSAfundedastudytocollectclinicalpharmacyservicesoutcomesdatafromoneofits networksofHRSAsupportedhealthcenters.Thestudywasconductedbyanimpartial, objective,nonpharmacy,researchcorporation:MathematicaPolicyResearch,Inc. Mathematicanotedthat,Thecurrentfinancingenvironmentcreatesamajorchallengeto sustainabilityoftheseservices.46Clinicalpharmacyservicescouldfeasiblyassistbothpatients (throughclinicaloutcomes)andproviders(byreducingtimeconstraints).However, Mathematicasuggestedthatreconsiderationofpaymentpoliciesareneededtorecognize thesepharmacyservicesasalegitimateapproachtocare.46Theseconclusionssuggestthat clinicalpharmacycouldplayamoresubstantialroleinthedeliveryofcareifsupportedby appropriatecompensationmechanisms. InMarch2011,thePatientCenteredPrimaryCareCollaborative(PCPCC)releasedBetterto Best:ValueDrivingElementsofthePatientCenteredMedicalHomeandAccountableCare Organizations.Thisconsensusreportpresentsfourthemesorvaluedrivingelementsthat eitherrequireurgentoverhaul(enhancedaccess,carecoordination)orareessentialtools (healthinformationtechnology,paymentreform)tooptimizevalueinhealthcare.47Regarding paymentreform,thereportreviewstheleadingproposedmodels: Feeforservice+managementfee+performancemodel Episodeofcare(caseratemodel) Riskadjustedcomprehensivepaymentandbonus Accountablecareorganization Pharmacistswithphysicianapprovedpatientcareprivileges,performinginexpandedclinical rolesofdiseasemanagement,andotherpatientcarefunctionscouldseamlesslybeavalue addedpiecetoanyofthesemodels.Oneadvantageofthedecadesofevidencebased performanceisthatourworkiscurrentlybuiltarounddemonstratingpositiveoutcomesthat subsequentlydecreaseoverallhealthcarecosts.Thepharmacyprofessionhasfrequentlybeen calledupontoproveitscapacityindemonstratingoutcomes.ThisReportcollatessome(but notall)ofthesuccess.Thus,pharmacistscouldbecompensatedappropriatelywithinanyone ofthesemodelsbasedonthelevelofserviceprovided. ThemostsignificantandinfluentialpayerfortheseservicesistheCMS.Manyadditionalthird partypayersfollowtheCMScompensationstructuresandguidance.Pharmacistsarenot currentlyrecognizedbyCMSashealthcareproviders,potentiallyimpedingsomeprivateand federalsectorpatientsfromreceivingoptimalqualitypatientcareservices.Asapointof comparison,theSocialSecurityActappropriatelyrecognizesanumberofotherhealthcare 30


professionalsasprovidersorpractitioners,includingphysicianassistants,nursepractitioners, certifiednursemidwives,clinicalsocialworkers,clinicalpsychologists,andregistereddieticians ornutritionprofessionals.RecognitionofpharmacistsashealthcareprovidersintheSocial SecurityActunderTitle18,PartE,Section1861isacriticaladditionoflanguageneededto sustaintheseservicestomeetthegrowingdemandsofaccesstocareaswellasserving vulnerableandruralpopulations.CMSpaymentpoliciesanddefinitionscanthenparallel pharmacistscurrentandcriticalroletoimprovehealthcaredelivery. LegislationHistory InMay2001,SenatorTimJohnson(DSD)introducedtheMedicarePharmacistServices CoverageActof2001intotheSenate.ThebillproposedchangestotheSocialSecurityActto provideforcoverageofpharmacistservicesunderPartBoftheMedicareprogram.Senator JohnsonexpressedthattheActwillreformMedicarebyrecognizingqualifiedpharmacistsas healthcareproviderswithintheMedicareprogramandmakeavailabletobeneficiaries importantdrugtherapymanagementservicesthatthesevaluablehealthprofessionalscanand doprovide.Theseservices,whicharecoordinatedindirectcollaborationwithphysiciansand otherhealthcareprofessionalsasauthorizedbyStatelaw,helppatientsmakethebestpossible useoftheirmedications.48Thislegislativemotiondemonstratedrecognition,atthelawmaking level,ofthevalueofpharmacistsashealthcareproviders.Thebillwasreferredtothe CommitteeonFinance,onlytobeclearedfromthebooksattheendofthesession.49 InAugust2001,theMedicarePharmacistServicesCoverageActof2001wasintroducedinto theHouseofRepresentatives.AfterbeingreferredtotheSubcommitteeonHealth,itremained thereuntilclearedfromthebooksattheendofthesession.50 In2004,theMedicareClinicalPharmacistPractitionerServicesCoverageActof2004was introducedtoproposechangestotheSocialSecurityActtoprovideforcoverageofclinical pharmacistpractitionerservicesunderPartBoftheMedicareProgram.Thiswasthefirsttime thatlegislationappropriatelyaddressedachangetotheSocialSecurityActthatwouldaddthe definitionofClinicalPharmacistPractitionertothelistofnonphysicianpractitionersalready beingreimbursedfortheirservicesthroughMedicare.Amonthlater,thebillwasreferredto theHouseSubcommitteeonHealth,andnofurtheractionwastaken.51 In2008,theMedicareClinicalPharmacistPractitionerServicesCoverageActof2008was introducedtoproposechangestotheSocialSecurityActtoprovideforcoverageofclinical pharmacistpractitionerservicesunderPartBoftheMedicareProgram.52Thebillwasreferred totheHouseSubcommitteeonHealth,andnofurtheractionwastaken.Again,thisbill demonstratedthatexpandingcompensationthroughMedicarePartBforthecognitive pharmacyservicesthesecliniciansprovideisthenextlogicalstep. In2010,theMedicareClinicalPharmacistPractitionerServicesCoverageActof2010was introducedtoproposechangestotheSocialSecurityActtoprovideforcoverageofclinical pharmacistpractitionerservicesunderPartBoftheMedicareProgram.Thisbillwasassignedto 31


theSubcommitteeonHealthonMay27,2010,butnofurtheractionwastaken.53Itwascleared fromthebookswiththeconveningofthe111thCongressinDecember2010. AsofJuly2011,therehavebeenthreepharmacyrelatedbillsthathavebeenintroducedinto the112thCongress,1stSession. H.R.891TheMedicationManagementTherapyBenefitsActof2011proposesto amendPartDoftitleXVIIIoftheSocialSecurityActtopromotemedicationtherapy managementundertheMedicarepartDprescriptiondrugprogram.54 S.48ThePharmacistStudentLoanRepaymentEligibilityActof2011proposesto amendthePublicHealthServiceActtoprovidefortheparticipationofpharmacistsin NationalHealthServicesCorpsprograms,andforotherpurposes.55 S.274TheMedicationTherapyManagementEmpowermentActof2011proposesto amendtitleXVIIIoftheSocialSecurityActtoexpandaccesstomedicationtherapy managementservicesundertheMedicareprescriptiondrugprogram.56

Multipleattemptstochangenationallegislationthroughbillshavebeenproposedinthelast10 years.Itappearsstatespecificbillsmaycontainnomenclaturethatislimitedinsuchawaythat documentation,support,orexplanationsareinsufficienttojustifythechange.Attemptshave beenmadetoconsultthemostexperienced,evidencebasedandinnovativefederal pharmacysystems(thathaveadvancedtheprofessionforthelasthalfcentury);however processbarriershavepreventedfurtherdiscussion.ThisReportcollatesmanyofthesedata pointsforthefirsttimeandcanbeutilizedbyhealthleadershiptoadvancethisdiscussion. Onastatelevel,NewMexicoMedicaidpioneeredapharmacistdirectedcompensation mechanismthathasexperiencedsuccessforanumberofyears.Inthemid1990s,pharmacists workedwiththeStateofNewMexicoBoardofPharmacyandMedicalExaminerstodevelopan advancedpracticelicensedesignatedasaPharmacistClinician(PhC).57NewMexicolegislation hasrecognizedPh.Cs,alongwithPhysiciansAssistantsandNursePractitioners,asmidlevel providerswithprescriptiveauthority.AsalicensedNewMexicoprovider,thePharmacist CliniciancanapplytobecomeaMedicaidprovider,andisthereforeeligibleforMedicaid reimbursement.58Thisprogramoffersanappropriatelevelofcompensationforeligible pharmacistsprovidinganadvancedlevelofcare.Thisstaterecognitiondemonstratesthat pharmacistscanberecognizedsuccessfullywithregardstoreceivinganappropriatelevelof compensation,andwithexperienceandlocalprivileging(includingsomelevelofphysician supervision).Althoughthedelineationofscopeisthroughseparatelicensureinthestateof NewMexico,itisnotnecessarilyneededasnewmodelsofcredentialingandprivilegingare considered.Withadditionalcompetencytrainingandassessmentbyphysiciansupervisors,a pharmacistcanbeprivilegedthroughaCPAandstillremainswithinthecurrentscopeofstate licensure.

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AnotherexampleofastatelevelattempttookplaceinMinnesota.In2001,Minnesota MedicaidpolicyrecognizedPhysicianExtendersasprimarycareproviders,makinganyone fallingintotheirclassificationsystemeligibleforreimbursement.Theclauselistedexamplesof PhysicianExtendersanddidnotspecificallynamepharmacists.Detailsofthedefinitionwere questioned.Stateofficials,althoughsupportiveoftheperspective,wereunabletodetermine whetherthislistwasallinclusiveormerelylistingexamplesofPhysicianExtendersbasedon thelevelofcareprovidedwassufficient.Ifthelatter,pharmacistsprovidinganddocumentinga similarlevelofcarecouldbeconsideredphysicianextenders.Afinaldeterminationwasnot madeatthattime.Sincethen,Minnesotahasbeeninnovativeintheiradvancementof paymentmechanismsforpharmacistsprovidingclinicalpatientcare. Onekeypointtoconsiderwiththeseprogramsandanyothersthatmaydevelopfromthe conceptsofthisReportisthatnotallpharmacistswillbeeligibleforthislevelofcompensation. Pharmacistseligibilityforhigherlevelsofcompensationcommensuratewithotherprimary careprovidersshouldbebaseduponthelevelofserviceprovided. MedicationTherapyManagement(MTM)underMedicarePartD Currently,pharmacistsareeligibletoreceivesomecompensationforMedicationTherapy Management(MTM)throughMedicarePartD.CMSdesignedtheseprograms(MTMP)to ensureoptimaltherapeuticoutcomesfortargetedbeneficiariesthroughimprovedmedication useandreducetheriskofadverseevents.59MTMprogramsareadministeredbyPrescription DrugPlans(PDPs)andarerequiredtobedevelopedincooperationwithlicensedandpracticing pharmacistsandphysicians.However,numerouspolicyconstraintslimitpatientparticipationin theseprogramsevenwiththe2010CMSenhancements. MedicarePartDrestrictspatienteligibility:Currently,onlyseniorage,disabled,andlow incomepatientsareeligibleforprescriptionbenefitsandMTMservicesviaPartD. However,diseasemanagementandallotherpatientcareservicesoccuratanyage withinourU.S.healthsystemasbothapreventivemeasureforprogressionor exacerbationofchronicdisease,andasatreatmentmeasure. PatientsmustbeaMedicarePartDparticipant:Forthosepatientsmeetingthe MedicarePartDeligibilitycriteria,monthlypremiumspayabledirectlybyparticipants arerequired.InthecurrentIHSsystemforexample,where100%ofhealthcare expensesforeligiblepatientsarecovered,thepatientperceivedbenefitofpaying monthlypremiumspossiblyreducesparticipationinMTMservices. EligibilityforMTMservicesvariesamongthePDPs:Patientswhosufferfromcomorbid chronicdiseaseslikediabetes,hypertension,dyslipidemia,musttakemultipleMedicare PartDcoveredprescriptionmedications,andmustincuratleast$3,000inMedicare PartDdrugexpensesannuallyinordertoqualifyforMTMservices.59CMSallowsthe PDPtodefinecertaineligibilityparameters:numberofmedicationsapatientmustbe taking,numberofchronicconditionsthepatientmusthave,andspecificdiseases covered.ThePDPalsodefineswhetheralldrugsarecovered,onlydiseasespecificdrugs areincluded,oronlyspecificdrugclassesareincluded.Becauseofspecifictargeting 33


criteria,patientswhomayneedMTMservicesbutdonotmeettheplanscriteriawill notbeabletoparticipate.MTMcompensatespharmacistsforasubsetofcognitive servicestheycanprovideinonlysomeofoursickestpatients. Enrollmenthasbeenhistoricallylow:In2006,approximately10%ofMedicarePartD enrolledparticipantsmetthecriteriaforMTMservices.Morerecentprogramyears showaslightincreasesto12%.60 MTMunderPartDdoesnotincentivizethehealthsystemtofocusonprevention:The growingincidenceofvariouscomplexdiseasestatessuchascardiovasculardiseases, heartfailureandhypertensionareaffectingpatientsatearlierstagesoftheirlives.61 Theseyoungerpatientsrequirepharmaciststospendsignificantamountsoftimeand resourcesmanagingtheirhealthcareneeds,butwithoutacompensatorymechanism forthepharmacistscognitiveservices.Thisdelayofcareseemstogoagainstcurrent medicalpracticeandwithholdsvalueadded,preventive,costeffective,andpatient centeredservicesuntilthecustomerhasprogressedtoamorecriticalstateofhealth. PartDSponsorscandeterminewhichdisciplineofprovidertodelivertheirMTM services:AlthoughpharmacistsarespecificallynamedbyCMSforMTMdelivery,and currentlyprovide99.9%ofservices,otherqualifiedproviderssuchasnurses,physicians, andotherNonPhysicianPractitionersrepresenthealthcarealternativesforutilization inMTMprograms.59

ThisReportrecognizesongoingandexpandedMedicarePartDreimbursementforMTM servicesiscriticalfortheadvancementofthepharmacyprofessioninmultiplesettings.Many MTMadvocatesareawarethatexpansionofeligiblebeneficiaries,aswellaspotentialincreases inlevelsofcompensation,willneedtotakeplaceinordertomakeMTMmoreapplicableina widervarietyofpharmacypracticesettings.ThisReportsupportsexpandedMTMprograms andotherpragmaticsolutionstothebarriersofeligibilityrequirements. FromPHSsongoingpharmacyexperiences,MTMPartDisutilizedwhenpatientsfitthe restrictivecriteriaandpharmacistshavethetimetocompleteadditionalpaperworkneededto obtainlimitedreimbursement.Themedicationtherapymanagementmodelimproves outcomes;however,eligibilityrestrictionsneitherfostercosteffectiveorefficientcarenor promotecomprehensivehealth,diseasemanagement,norpreventionofprogressionofdisease orprimaryprevention.AlthoughratesandfrequencyofcompensationforMTMservicesare welldefinedinmostMedicarePartDplans,theymaynotbeadequatetosupportorsustain provisionoftheseservices.Also,MTMserviceopportunitiesareofferedonlyperiodicallyand appearprimarilytargetedtowardexpandedpatientmedicationprofilereviewsand/or physicianintervention,includingidentificationofdrugrelatedproblems,genericconversion potential,andmedicationadherence.Whilepatientmedicationreviewsclearlyreduceand avoidmedicationrelatedadverseeffects,itisonlyonecomponentinthepotentialarrayof patientcareprovidedbypharmacists.Furthermore,therateofcompensationofferedbymost PartDsponsorsdoesnotequatetothedegreeandcomplexityofcaredeliveredinpharmacist deliveredpatientcarevisits.Asdescribedabove,thebreadthofknowledgeandskillrequiredby anyphysician,NPP,orpharmacisttodeliverprimarycareisnotreflectedwithcurrentMTM PartDcompensatoryrates.Whileperiodic,limitedcognitivecompensationisopenlyoffered 34


throughMTM,thereremainsapprehensionwithinthePHSPharmacyprogramtocontractwith PDPsofferingMTMProgramsduetoquestionablecosteffectivenessandresourcesto implementonanationalbasis.Intheprivatesector,MTMhasimprovedtheutilizationof clinicalpharmacists;howevergrowthisslow,inpartbecauseofpatientrestrictionsand inadequatecompensation. Restrictions,eligibilityconstraints,andfiscalconsiderationslimitthefeasibilityofMTMPartD becomingacentral(orsubstantial)sourceofcompensationorrevenueforservicesforany healthprofessional.Uponliteraturereview,nostudiesofotherNPPs(eligibleforMTM compensation)havebeenfoundtoutilizeMTMastheirprimarysource(orevenanadequate source)ofcompensation.Yet,atthistime,itisbasicallythesolemechanismforcompensating pharmacistsforcognitiveand/orprimarycareservices. EventhelargestofindustrygiantscanidentifyapotentialbarrierintheutilityofMTM. WalgreensChiefExecutive,GregWesson,wishedtohavehisarmyofcoachestakeona greaterroleforPresidentBarackObamaastheWhiteHouseandCongresscametogetherto expandhealthinsurancecoveragetothenation'suninsured.Wessonsayshiscompany's effortsgobeyondjustfillingprescriptionsaspartofasolutionhecallsmedicationtherapy management,wherehelpingpatientssticktotakingtheirmedicationsandmakingbetterand morecosteffectivechoices...couldhelpsavebillionsofdollarsinmedicalcarecosts.But WessonalsosaysthattomakeMTMwork,pharmacieswouldneedtobepaidmore,andthe paymentswouldneedtoincludethetimetoprovidepatientconsultations,pluswellnessadvice andothertips.62 Asnoted,pharmacistspracticeinmanydifferentsettings.Theprovisionandcoreconceptsof MTM,underMedicarePartD,arenotintendedtoparallelthecomprehensivenessofaprimary carepracticeorvisittoahealthcareprovider.Ina2011publishedstudybyKucukarslanetal., evidencesuggestsMTMservicesarecapableofprovidingmeasurableimprovementsintwo areas:patientswhoarenewlydiagnosedwithachronicconditionandpatientswhohavenot yetachievedtheirtherapeuticgoal.63However,pharmacypracticesettingsbestsuitedforMTM serviceswithregardtotheMedicarePartDmodeloftenlackaccesstoafullpatienthealth record,adequatestaffingandguidance,andtheprescriptiveorlaboratoryprivilegesusually neededforcomprehensivepharmacistdeliveredpatientcare.MTMservicesinallpractice settingsneedtocontinueinordertoimprovehealthsystemandpatientoutcomes;however, changesineligibility,compensationmechanisms,andbarrierstoimplementationneedongoing advancementandsupport.

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FocusPoint4:EvidenceBasedAlignmentwithHealthReform Throughthedeliveryofpatientcareservices,pharmacistsimproveoutcomes,increaseaccess toservicesformedicallyunderservedandvulnerablepopulations,improvepatientsafety,shift timeforphysicianstofocusondiagnosisandmorecriticallyillpatients,improvepatientand providersatisfaction,enhancecosteffectiveness,anddemonstrablyimprovetheoverallquality ofhealthcarethroughevidencebasedpractice. QualityofCareandPatientOutcomes Pharmacistsinvolvedinthedeliveryofpatientcareserviceswithappropriateprivilegesacross manypracticesettingshavebeensuccessfulatimprovingpatientoutcomes.The implementationofmoreexpandedpharmacypracticemodelsdemonstratesimproved performancemeasuresthroughevidencebasedoutcomes.Hundredsofpeerreviewed publicationsandsustainedinterprofessionalsupportindicatethatthissuccessfulpracticeis bothevidencebasedandacceptedasanadditionalmodelofhealthcaredeliverywith improvedaccesstopatientcareservices.Aspresentedbelowthroughlargedatabasereviews, pharmacistdeliveredpatientcareservicesclearlyhaveapositiveimpactondiseaseoutcomes (preventionandmanagement),qualitycare,accesstocare,costcontainment,patientsafety, andoverallhealthsystemefficiency. Diabetes:Machadoetal.reviewedandidentified302articles,including108pharmacists interventionsencompassing2,247patientsin16studies.Theyfoundasignificantreduction inhemoglobinA1Clevelsindiabeticpatientsinthepharmacistinterventiongroup.64 Hypertension:Machadoetal.performedaliteraturebasedmetaanalysisthatinvolved203 articles,2,246patientsin13studies.Theyfoundpharmacistsinterventionssignificantly reducedsystolicbloodpressure.65 Dyslipidemia:Machadoetal.found48studies,ofwhich23metinclusioncriteria,that demonstratedasignificantreductioninbothtotalandLDLcholesterolinthepharmacist interventiongroup.66 Congestiveheartfailure:Twosystematicreviewsoftheliteratureconcludedthat pharmacistscanimprovepatientcareandreducetherateofhospitalization,particularlyin heartfailurepatients.67,68 Costcontainmentandhealthsystemefficiency:ACochranedatabasereviewof25studies involvingmorethan40pharmacistsand16,000patientsfoundexpandedpharmacist servicesledtoadecreaseinthenumberofnonscheduledhealthservices,aswellasa decreaseinspecialtyvisitsandthenumberandcostofdrugs.69 Qualitycareandpatientsafety:UniversityofArizonaresearchersconducteda comprehensivesystematicreviewwithfocusedmetaanalysistoexploretheeffectsof pharmacistprovideddirectcareontherapeutics,safety,andhumanisticoutcomes.Atotal of298studieswereincludedandtheresearchersfoundfavorabletherapeuticandsafety outcomes.Additionally,theyconductedametaanalysisstudyofspecificqualitycare

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indicators(HgA1c,LDL,bloodpressure,etc.)andtheresultsweresignificantlyinfavorof pharmacistdeliveredcareovercomparativeservices.4 Becausethequantity,depth,andvarietyoftheseclinicalstudiesarefartoonumeroustodetail inthisReport,apartialsummaryofpublishedoutcomeshasbeenprovidedinAppendixB. Nearly60studieshavebeencitedfromvariouspeerreviewedpublications.Insomecases,as denotedabove,apublishedstudymaybeametaanalysisofmanyadditionalstudiesyieldinga substantialamountofdocumentedoutcomes.Thesepublishedoutcomesarecollectedfrom variouspracticesettingstoincludecommunity,hospital,andfederalfacilities,anddemonstrate improvedoutcomes(patient,administrative,economic,etc.)amongpharmacistmanaged clinicsandprograms.25,70104 AlthoughdiscussioninthisReportfocusesonimprovinghealthcaredeliverythroughutilization ofthepharmacist,apivotalpiecetosuccessfulimplementationalsohingesoncontinuedefforts toleveragehealthinformationtechnology(HIT).HIThaslongbeenrecognizedasakeymeans forsupportingimprovementsinhealthcarequality,safety,andefficiency.Withthepassageof theHealthInformationTechnologyforEconomicandClinicalHealth(HITECH)Actin2009,many healthcarecollaborationswereformedtosupportandadvanceHITtothefullestextent. AccordingtothePatientCenteredPrimaryCareCollaborative(PCPCC),healthITcanprovide criticalinformationaboutthepatienttotheentirecarecoordinationteamacrossallstagesof care,supportphysicianpatientcommunication,enablemoretimelyandaccurateperformance measurementandimprovement,andimproveaccessibilityofthephysicianpracticetothe patient.105 ThepharmacyprofessionhastraditionallybeenanearlyadopterofHITandrecognizesthe benefitsofHITtooptimizingpatientcareandoutcomesbasedmeasurement.In2010,nine nationalpharmacistassociationsformedthePharmacyeHealthInformationTechnology Collaborative(eHITCollaborative)tofocusonandensurethetechnologyneedsofthe pharmacyprofessionadvancewiththefederallyincentivizedprogressionofHITinfrastructure intheUnitedStates.ThegoalofthiscollaborativewastodefineacommonvisionforHITto improvepatientcarequalityandoutcomesthroughtheintegrationofpharmacistspatientcare servicesintothenationalelectronichealthrecords(EHR)infrastructure.ThefocusoftheeHIT Collaborativeistoassurethemeaningfuluse(MU)ofstandardizedEHRtosupportsafe, efficient,andeffectivemedicationuse,continuityofcare,andprovideaccesstothepatient careservicesofpharmacistswithothermembersoftheinterdisciplinarypatientcareteam.The eHITCollaborativeassuresthepharmacistsroleofprovidingpatientcareservicesisintegrated intotheNationalhealthITinteroperableframework.106TheeHITCollaborativeispursuing EHRstandardsthatsupportthedelivery,documentation,qualitymeasures,andbillingfor pharmacistprovidedpatientcareservicesacrossallcaresettings.Thus,thepharmacy professionhasalreadyrealizedtheclinicalutilityofelectronichealthdataandhaspositioned itselfwellaheadofthecurveforstandardizedoutcomesrelateddatacollectionandenhanced electronicdataaccessibilityfordeliveringqualitypatientcareservices. 37


DiseasePreventionandManagement Diseaseprevention,orprogressionofchronicdisease,directlyalleviatesthedisproportionate amountofchroniccareneedsanddemandsonthehealthsystem.Approximately125million Americans(45percentoftheU.S.population)hadoneormorechronicconditionsin2000and 61million(21percentoftheU.S.population)hadmultiplechronicconditions.Itisestimated thepopulationofpeoplewithchronicconditionswillincreasesteadily,andthatby2020,164 millionpeople(almost50percentoftheU.S.population)willhaveachronicconditionand81 million(24percent)ofthemwillhavetwoormoreconditions.107,108Inpatientadmissionsfor ambulatorycaresensitiveconditionsandhospitalizationswithpreventablecomplications increasedwiththenumberofchronicconditions.Asanexample,Medicarebeneficiarieswith fourormorechronicconditionswere99timesmorelikelythanabeneficiarywithoutany chronicconditionstohaveanadmissionforanambulatorycaresensitivecondition(95% confidenceinterval,86113).PercapitaMedicareexpendituresincreasedwiththenumberof typesofchronicconditionsfrom$211amongbeneficiarieswithoutachronicconditionto $13,973amongbeneficiarieswithfourormoretypesofchronicconditions.109Thenumberof peoplewithchronicconditionsisprojectedtoincreasesteadilyforthenext30years.While currenthealthcarefinancinganddeliverysystemsaredesignedprimarilytotreatacute conditions,78percentofhealthspendingintheUnitedStatesisdevotedtopeoplewithchronic conditions.110 ChronicdiseasesaretheleadingcausesofdeathanddisabilityintheUnitedStates.Chronic diseasescurrentlyaffect45percentofthepopulation(133millionAmericans),accountfor81 percentofallhospitaladmissions,91percentofallprescriptionsfilled,76percentofphysician visits,andcontinuestogrowatdramaticrates.111Thesenumbersaredaunting.Qualitymedical careforpeoplewithchronicconditionsrequiresaneworientationtowardpreventionof multiplechronicdiseaseconditions,andprovisionofongoingcareandcaremanagementto maintaintheirhealthstatusandfunctioning. Ithasbeenstatedthatspecificfocusshouldbeappliedtopeoplewithmultiplechronic conditions.107,108However,asinglechroniccondition(forexample,hypertension)causesmany otherpotentialcomorbiditiesandnegativehealthoutcomes.Anychroniccondition,even withoutcomorbiditieswouldbenefitfrompreventionofdiseaseprogression.Thismustbe realizedindiscussionandappliedtolegislationinvolvinghealthcaredeliveryparadigmsin ordertoprovidethehighestqualityandmostcosteffectivecare(bothshortandlongterm). Thisperspectivemustalsobeevidentinlegislationtominimizeanyrestrictionsplacedon eligibilityforthesetypesofserviceswhethertheyaredeliveredbypharmacistsornot.Asa reminder,insomeMTMPartDcases,thepharmacistisnoteligibletopracticeMTMunlessthe patienthasmorethanonechronicdisease.Thehealthsystemwouldnotrestrictprimarycare deliveredbyaphysicianorothercareprovidersimplybecauseapatienthasonlyonechronic disease.Whywoulditdosointhecaseofpharmacistdeliveredservices?Whywoulditdosoin asystemthatisattemptingtopreventfurtherprogressionofdiseaseordevelopmentofnew comorbidconditions?Pharmacistsareuniquelyqualifiedtoworkwithinthisscope,with

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extensiveformaleducationontherapyandmanagementofchronicdisease(singleormultiple) throughthesafeuseofpharmacologicinterventions. TheDiabetesTenCityChallenge(DTCC)wasamultisitecommunitypharmacyhealth managementprogramforpatientswithdiabetes.Itwasanemployerfunded,collaborative healthmanagementprogramusingcommunitybasedpharmacistcoaching,evidencedbased diabetescareguidelines,andselfmanagementstrategies.DTCCsuccessfullyimplementedthe programanddemonstratedpositiveclinicalandeconomicoutcomesfor573patientswho participatedintheprogramforatleastoneyear,comparedwithbaselinedata.However,in additiontotheclinicalandeconomicbenefits,manypreventivemeasuresshowedsubstantial improvementdemonstratingthevalueofpharmacistsinpreventivecare.Betweentheinitial visitandtheendoftheevaluationperiod,influenzavaccinationratemorethandoubledfrom 32percentto65percent,eyeexaminationrateincreasedfrom57percentto81percent,and footexaminationrateincreasedfrom34percentto74percent.70

TheAshevilleProjectisyetanotherwidelyknownexampleofsuccessfulpharmacistdelivered patientcareinthenonfederalsector.Itbeganin1995asaresultofastrategicplanning committeeheldbystatepharmacyleaders.Theideawastosponsorapharmaceuticalcare demonstrationprojectinthestateofNorthCarolina.TheAshevilleprojectutilizedadvanced practicepharmacists,incoordinationwiththeDiabetesEducationCenterandphysiciansto provideDiseaseStateManagement(DSM)servicestopeoplewithdiabetes.112Theoutcomes wereextremelypositiveintermsofbothfiscalandclinicaloutcomes.TheAshevilleProject demonstratedthatpatients,providers,andmanagersbelievedalignedincentivesand communitybasedresources(i.e.,pharmacists)providinghealthcareservicestopatientsoffera practical,patientempowering,andcosteffectivesolutiontoescalatinghealthcarecosts.113 Morerecently,acollaborativeprojectinConnecticut(ConnecticutMedicaidProgram;the ConnecticutPharmacistsAssociation;andtheUniversityofConnecticutSchoolofPharmacy) testedapharmacistpracticemodelinpatientswithchronicconditionsandcomplexmedication regimes.Althoughsmallsamplelimitationandgeneralizabilitywereaddressed,thestudy demonstratedthatpharmacistsarecrucialforoptimizingpatientoutcomeswithregardsto diseasemanagement.Therewere369facetofaceencounters,andpharmacistsidentified917 drugtherapyproblems.Pharmacistsresolved78percentoftheseproblemswithoutthepatient havingtobereferredbacktotheirprimarycareprovider.Additionally,82percentof prescribersmadechangesintheirpatientstherapiesbasedonthepharmacists recommendations.114 Withaprojectedshortageofgeneralprimarycarepractitionersandagrowingmassofeligible consumers,theReportstronglyencourageshealthleadershiptoconsiderpharmacistsas providersthatcanassisttoreducetheburdenofchronicdiseaseonthehealthcaresystem, especiallyincaseswherefurtherprogressionofdiseaseordevelopmentofcomorbid conditionscanbeprevented.

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CostEffectivenessandCostContainment Inadditiontopharmacistsabilitytoimproveclinicaloutcomesforpatientsthroughdisease managementorotheradvancedclinicalroles,pharmacistshavecontainedorreducedhealth carecosts,whetherassociatedwithreducedadverseclinicalevents(hospitalizations, emergencyroomvisits,etc.),115,116reducedoutpatientvisits,costsavingstoahealthcare institutionorhealthinsuranceplan,93,95,112,116123directcostsavingstothepatient,124,125orless missed/nonproductiveworkdays.112,115BondandRaehlhaveshownonamacrolevelthat advancedpatientcareservicesdeliveredbypharmacistsreducedrugrelatedmorbidityand mortality,andlowertheoverallcostofcare.126 Utilizingpharmacistsasdrugtherapyexpertswillmaximizeresources,containorreducecosts andimprovecare.Significantreductionsindrugmisadventurescouldbepotentiatedby allowingpharmacistsgreaterclinicalinterventionandcomprehensivemedicationmanagement authorities.Byselectingandmonitoringtherapeuticandpatientcareregimensthroughfocused diseasemanagement,pharmacistscanimprovetheoverallqualityofthehealthcaresystem. Pharmacistshavebeenshowntoproduceannualhealthcaresavingsof: $3.5billioninhospitalcostsbycoordinatingmedicationsfrommultipleproviders.127 Morethan$1,600indirecthealthcarecostsperpatientatapharmacistrun anticoagulationclinic,comparedwithusualmedicalcosts.93 $1,200to$1,872perpatientindirecthealthcarecostsforpatientswithdiabetes enrolledintheAshevilleProjectforuptofiveyears.112 $918perpatientindirecthealthcarecostsforpatientswithdiabetesenrolledinthe PatientSelfManagementProgramforDiabetesforoneyear.113 $1,230perpatientinindirectcostsforthosewithasthmaanddirectcostsavingsof $725averageperpatient.115 $1,123perpatientonmedicationclaimsand$472perpatientonmedical,hospital,and emergencydepartmentexpensesatfiveprimarycaresitesinConnecticut.114(The pharmacistsinthisstudyprovidedcomprehensiveevaluationofmultiplemedical conditions.)

TheAshevilleProject,inwhichmorethan50percentofpatientsinthestudyimproved clinically,alsodemonstratednotableadministrativeandfiscalbenefits: Patientandphysiciansatisfactionincreasedandhealthcarecostswerereduced. Directmedicalcostsdecreasedby$1,200perpatientperyearandanestimatedannual increaseinproductivityof$18,000duetoreductionofsicktimewerereported.115Even afterpayingthepharmaciststoprovidetheseservices,netcostswerelower.112

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Schumocketal.123,128andPerezetal.129conductedmultipleACCPfundedstudiesacrosstwo decadesthatevaluatedtheeconomicvalueofclinicalpharmacyservices.Collectiveresearch supportedsignificanteconomicsavingsinabroadrangeofclinicalcategoriesamongmultiple caresettings(SeeTable1:BenefittoCostRatio).Thecategoriesincludeddiseasemanagement, generalpharmacotherapeuticmonitoring,pharmacokineticmonitoring,targeteddrug programs,patienteducationprogram,andcognitiveservice.Thetablebelowrepresents economicvalueofclinicalpharmacyservicesintheformofbenefittocostratio(financial benefit/dollarinvestedtoprovidetheservice)fortheperiodsshown.Thebenefittocostratio wascalculatedbydividingthereportedgrosseconomicbenefitsderivedfromtheservice,by reportedtotalcoststoprovidetheclinicalpharmacyservicedescribedforthesametime period. Table1:BenefittoCostRatio Benefitto CostRatio 19881995 19962000 20012005 Lowest Highest Median Mean Evenattheratioslowestlevel,clinicalpharmacyservicesbenefitisstillhigherthanthecost. Theaveragebenefitgainedineachofthetimeperiodsshownwasbetween5.5and16.7times greaterthancost.Consequently,foreachdollarinvestedintheclinicalpharmacyserviceover theperiodfrom1988to2005(nearlytwodecades),theoverallaveragebenefitgainedwas $10.07per$1ofallocatedfunds. Onefinalwaytomeasurethecostefficienciesofpharmacistdeliveredpatientcareisto considerthecalculatedreturnoninvestment(ROI).ThisROIreflectsthevalueoftheservice basedonthecostofdeliveringtheservice.Thedatacollectedfrommedicationmanagement servicesdemonstratedanROIofashighas12:1andanaverageof3:1to5:1.Thisvalueis basedontheabilityofmedicationmanagementservicestoreducehospitaladmissions,reduce theuseofunnecessaryorinappropriatemedications,andreduceemergencyroomadmissions andoverallphysicianvisits.130131 Thus,effectivepatientcareservicesrelatedtomedicationmanagementcanlowertotalhealth carecosts.Althoughinitialmedicationcostsmayriseduetoimprovedmedicationadherence,it hasbeenshownthathospitalandemergencyroomvisitsarereduced.3Giventhesignificanceof thiscalculationandthechallengingeconomicenvironment,theROIofmedicationmanagement servicescanbeseenasalegitimatecostcontainmentandcosteffectivestrategyforhealth plans,employersandotherthirdpartypayers. $1.08:$1 $75.84:$1 $4.09:$1 $16.70:$1 $1.70:$1 $17.01:$1 $4.68:$1 $5.54:$1 $1.02:$1 $34.61:$1 $4.81:$1 $7.98:$1

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PrimaryCareWorkforce Inrecentyears,manyreportshaveidentifiedanimminentshortageofprimarycare physicians.132135Ashealthreformpressesforward,trendsinhealthcareworkforcecapacity maybecomethecriticalissue.Solutionsareminimal,yetcurrentdatashowsthenumberof graduatingphysiciansenteringprimarycareisdecreasing,dueinparttohighpatientloadsand decliningrevenuewhencomparedtospecialists,amongotherreasons.135137Thebackboneof theAmericanmedicalsystemisthreatenedbythissevereshortageofprimarycarephysicians, whichcouldleadtofragmentedhealthcare.135 ProvidingaffordableandaccessibleinsurancetoallAmericansdoesnotsolvetheproblemof accesstoservicesofthoseinsured.Thosegaininginsurancebenefitsasaresultofhealthreform arepartofthemedicallydisenfranchisedpopulationintheUnitedStates.AccordingtoAccess Denied,mostpeoplelivinginthesedisenfranchisedareashavehealthinsurance.134Ithasbeen saidthathavinginsurancecoveragewithoutasourceofcareislikehavingcurrencywithouta marketplace.132ArecentandcomprehensivereportfromtheAssociationofAmericanMedical Colleges(AAMC)CenterforWorkforceStudiesenumeratedroughly26referencedocuments andarticlesthatallspeaktocurrentandfuturephysicianshortages.Someofthestudies projectedaphysicianshortageanywherefrom85,000to200,000by2020,138anda38percent increaseindemandforgeneralinternistsisprojectedbytheyear2020.136Thesearenot predictions.Theseprojectionsindicateifcurrentphysicianutilizationandworkpatterns continue,aphysicianshortageisimminentifitisnotalreadyhere.Thereportalso hypothesizednonstaticmodelsthatdemonstrate: Growthinfuturedemandcoulddoubleifvisitratesbyagecontinuetoincreaseatthe samepacetheyhaveinrecentyears; Universalhealthcarecoveragecouldadd4%todemandforphysicians;thiswould increasetheprojectedphysicianshortfallby25%tonearly155,000physicians;and Iftherelationshipbetweeneconomicgrowthandphysiciandemandholdstruea demandforphysicianswilloccurthatislikelybeyondwhatsupplycouldmeet. Ifyoungerphysicianscontinueworkingfewerhoursthantheirpredecessors,which seemsprobable,thenanyandallshortageswillbeamplified. Evenamodestincreaseinphysicianproductivitycouldalleviatesomeoftheprojectedgap,but productivityimprovementsinhealthcarehavebeenhardtoachieveascarehasbecomemore complex.Anincreaseinhealthcarecoveragewouldintroducemillionsofpatientsintoan alreadystressedsystem,furtherincreasingthenumberofmedicallydisenfranchised.Atleast 12stateshavealreadyreportedcurrentorprojectedphysicianshortages(AZ,CA,FL,GA,KY, MA,MI,MS,NC,TX,OR,andWI).133Thecurrentsupplyofphysicianswouldsimplybeunableto provideprimarycaretotheincreasedpopulationofinsuredindividuals.

ThisReportsupportsmaximizingtheutilityofthecurrenthealthcareworkforce.Thereisan identifiableandprojectedneedwherebypharmacists,throughadvancedpharmacypractice models,cancontribute.139Currenthealthsystemsutilizeothernonphysicianproviders. 42


PhysiciansworkalongsidePAs,NPs,andotherhealthprofessionalswhoincreasethe productivityofphysiciansbothbyassistingwithpatientcareandprovidingpatientcare(i.e., providingcomprehensiveassessmentforaprimarycarevisit)underthedirectionofa physician.TheAAMCreportcitesofparticularimportanceareclinicianswhocanprovidesome oftheservicesusuallyprovidedbyphysicians.140TheseNonPhysicianPractitionerslisted includePAs,NPsandothers.Toparallelcurrentpharmacypractice,thisReportclearly articulatesthatpharmacistscanfunctionashealthcareprovidersandprovidedirectpatient careservices.Increasingthecapacityofpharmaciststoprovidetheseservices(through recommendationsinthisReport)willprovideoneexistingsolutiontoaddresssomeofthe growingshortagesanddemandforprimarycareservices. TheAAMCreportalsoconsiderstwoscenariostoassistwiththedemandforprimarycare servicesinwhichNPsandPAs:1)increasetheirgrowthbeyondbaselineor2)providemore primarycareservices.Whilethesetwoscenariosprojectfuturedemandunderwhatmaybe attractivepolicygoals,currentinfrastructuremightbeinsufficienttoproducethevirtual doublingofPAandNPsupplythatthesehypotheticalscenarioswouldrequire.Thereport suggeststhatPAandNPnumberswillnotbesufficienttoeliminatethephysicianshortage likelytocome.Nonetheless,itappearsevidentthatanincreasedroleintheprovisionofcareis justonepartofthesolutiontotheprojectedshortage.TheAAMCreportproposestoreduce physiciandemandbasedonanincreasedroleforPAsandNPsinprimarycare.However,PAs areincreasinglymovingintononprimarycarespecialties.Thus,trendsinPAandNPspecialty choicemayalsorequireascloseawatchasthoseforphysicians.133Addingpharmacistsintothe modelsofthisparticularreportwillsubstantiallyboostaccessanddistributionofprovidersthat provideprimarycareservices.MuchlikecurrentrolesintheIndianHealthService,PAs,NPsand pharmacistsplayalargerroleinruralandmedicallyunderservedareasaswellasoffering servicestothosewithoutamedicalhome.Thehealthsystemwillbetterutilizepharmacists acrosstheUnitedStatesiftheyaregivensimilarpatientcarerolesthatleveragetheirexpertise infocusedorcomprehensivediseasemanagement.Thisprovidesmoreopportunitytoimprove patientandhealthsystemoutcomes. Thereareotherbenefitsofinvolvingapharmacistinprimarycaresettings.IntheUK,a databasehasestimatedthereareabout57millionprimarycarephysicianconsultationsper year.About51.4millionoutofthoseareforminorailmentsalone,whichalsocouldbehandled byapharmacist.141AsimilarmodelhasbeeninplaceintheIHSfromtheearly1970swiththe initialPharmacyPractitionerProgram.Muchofthismodeldissipatedasaresultofgrowthin thedispensaryroleofthepharmacistaswellasthelackofappropriatecompensation.The detrimentalcombinationofthenumberofpatientsthatneedprimary/chroniccare,highuseof medications,providershortages,andshortenedappointments,doesnotprovideadequatetime tofocusoncomprehensivediseasemanagementorotherimportanthealthissues.These factorscreateastrainedpracticeenvironmentwiththepotentialformultipleliabilityissuesand suboptimaloutcomes.

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Pharmacistshavedemonstratedtheircompetenceashealthcareprovidersinthedeliveryof patientcareservices.Additionally,ithasalsobeensaidthepresenceofpharmacistsembedded withinthecommunityallowspharmaciststoplaytheroleofgatekeepertothehealthcare system.142Thissupportsthenotionthatpharmacistsalsoprovideprimarycarethroughcare coordination.Aspreviouslydiscussed,pharmacistsareequippedtoprovidecomplementary clinicalservicestosupplementphysiciancarewithexpertiseinmanagingdiseaseoutcomes throughmedicationuse.HealthyPeople2020statesasoneapproacheshealthequity,health disparitiesbecomesmaller.143Aspublichealthprofessionals,throughinterprofessional practice,pharmacistscandirectlyaffecthealthdeterminantsineachofthelevelsprovidedby theHealthyPeople2020ActionModel. AccesstoCare AreportfromtheNationalAssociationofCommunityHealthCentersstates56million Americansaremedicallydisenfranchised:theydonothaveahealthcarehome.93,132,134Oneof themostcommonproblemsofourhealthsystemisthatevenifpatientshavehealthcare coverage,itmaynottranslateequallyasaccesstocare.Thus,increasingaccesstoqualitycare forthoseAmericansnecessitatesdiscussiononhowtoalleviateadditionalburdenonthehealth systemandproviders.Anotherreportstateshospitalizationratesandexpendituresarehigher inareaswithfewerprimarycarephysiciansandlimitedaccesstoprimarycare.144Ruralareas attractfewerdoctors,andthusbecomeoverburdenedmoreeasily. Asignificantcontributiontohealthreformbythepharmacyprofessionmaybetoincrease accesstopatientcareservices,incollaborationwithotherprimarycareproviders, particularlytotheunderservedormedicallydisenfranchisedpopulations. PharmacistsarethemostaccessiblehealthcareprofessionalsintheUnitedStatesandhave alwaysbeenoneofthemosttrustedprofessions.145A2000estimateofpharmacypatronage showedthattheequivalentoftheentireU.S.population(approximately275millionpeople atthetimeofpublication)visitedpharmacieseachweek.146Thisstatisticaloneisremarkable andsuggests,asaprofession,pharmacistsareunderutilizedinaddressingthehealthcare needsofthenation.Asnoted,physiciansarecurrentlyoverburdened,andtheproblemisonly goingtoworsenasthefirstofthebabyboomergenerationturns65in2011.TheU.S. populationasawholeisaging;itisprojectedby2030,oneinfiveAmericanswillbeoverthe ageof65.136147OlderAmericansrequiremorehealthcare,includingofficevisits,hospitalvisits, andprescriptions. PhysiciansintheNCPSsurveyinFocusPoint1(InterprofessionalCollaborationandSupport) affirmthatpharmacistsofferincreasedaccesstocareforunderservedpopulationswhereother primarycareprovidersareinlimitednumberordistribution.Pharmacistscandecrease physiciansroutineorchronicworkloads,potentiallyincreasingtheamountoftimephysicians canspendwiththeirmorecomplexpatientsprovidingincreasedrevenuesperphysicianunit time.Generallythephysicianinitiallydiagnosesthepatient,sendsthemfordisease managementwiththepharmacistforcontinuedregularfollowup,laboratorymonitoring,and 44


somelevelofprescriptiveauthority,butthephysicianremainsasthedriverbehindthesystem. Thepharmacistprovidesprimarycarecollaboratively,managingthepatientforoptimaldisease outcomesthroughmedicationuseandpreventingdiseaseprogressionorexacerbation. Pharmaciststhatdeliverdirectpatientcareservicescanreducephysiciantimespentonthese patientsbyeliminatingmultiplefollowupvisitswiththephysicianandincreasesfocused diseasemanagementbythepharmacist:creatingawinwin(nonzerosumgain)situation. TheU.S.healthcaresystemistransformingtoincludeincreasedhealthcoverage,whereaccess toprimarycareandaccesstoqualitycarewillbecomeparamountfortheprojectedmillionsof newbeneficiaries.Withincreaseddemandforservices,itwillbeessentialtoconsiderall populations,includingracialandethnicminorities,medicallyunderserved,andvulnerable populationswithadditionalhealthdisparities.Primarycarehealthservicesarenowafocusof alargerhealthcarestrategyinwhichagreatneedfortheseserviceswillevolve.DeMaeseneer etal.arguedprimarycarecontributestopublichealthbyimprovingaccess;howeverthey addedthatprimarycarealsocontributestosocialcohesionandempowermentofpeopleso thattheybecomelessvulnerable.148Thisonlyoccurswhenqualityofcareandhealthcare deliveryisoptimized.Coveragewithoutaccess,coupledwithaccessibilitywithoutquality, coulddevelopintoaperilouspublichealthsituation.Pharmacistsmaybeinthebestposition ofanyhealthprofessionaltoeffectivelymeetthedemandsandaddressthechangingneeds ofthehealthcaresystem. PharmacistsarethemostaccessiblecadreofhealthprofessionalsintheUnitedStatesandare remarkablyunderutilizedinourhealthcaresystem.Thepharmacyprofessionisuniquely situatedtoexpandtohelpmeetourhealthcaresystemschangingneeds.Pharmacistshavethe appropriateeducation,training,scope,andsupport(asprovidersofpatientcare complimentarytoexistingproviders)todeliverqualitycare.Pharmacistsalreadyperformas healthcareprovidersinthePHSandfederalpharmacysettings,andsomenonfederalhealth systemsaswell.Thesepharmacistsaretrainedtohandlethistypeofroleandcanrapidly expandtomeetsomeofthedemandforaccesstocareacrossthenationespeciallyif appropriatepolicystructuresareinplace.Thecosttothesystemtoimplementthischangeis minimalasitismoreachangeinpolicyandperceptionthanitisachangeinfiscalresources. TheAmericanPharmacistsAssociation(APhA)statesthatbyexpandingtheuseof pharmacistsexpertiseinthetreatmentofchronicdiseases,monetarysavingsandpatient careimprovementscanhelpsolvemanychallengesfacingtheU.S.healthcaresystem.149 Dramaticchangesareneededtofixourhealthcaresystem:expandingcoverageandaccessto all;reformingcompensationtopromotevalue;supportingclinicianseffortstoreengineercare; andengagingpatientsinmakingbetterchoicesandmanagingtheirhealthconditions.The burdenofhealthcareintheUnitedStateswilllikelybroadentocreateanevengreaterneed throughincreasingworkloadandplansofmoreuniversalinsurancecoverage.Trulybetter qualityofcarecarethatismoreeffective,safe,andefficientisimperativeforaidingour nationseconomicrecoveryandmakinggoodonourcommitmenttocovertheuninsured.150

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CONCLUSION MultiplebillsandcommitteebriefingshavebeensubmittedtoCongressfromleadingpharmacy andnonpharmacyorganizationsthatwouldfullysupport,utilize,andadvancethepharmacy professionbymaximizingpharmacistsvaluewithincurrenthealthdeliverystructures.31, 11,48,111,151153 Implementationofthesepharmacypracticemodelsrequirestrongandurgent considerationaspartialsolutionstothedemandforhealthcareintheUnitedStates.Existing pharmacypracticemodelscanrapidlyrelievesomeoftheprojectedburdenofaccessto qualitycare,reducehealthdisparities,andimproveoverallhealthcaredelivery.Pharmacists areintegraltotheprovisionofandaccesstoqualitypatientcare.Maximizingtheexpertiseof thepharmacist,pharmacyprofession,andeachpharmacypracticeiscriticaltoadvanceour nationshealth. Physicians,administratorsandpatientsthathaveworkedwithinthisparadigmofcollaborative patientcaredeliveredbypharmacistshavesupportedandcontinuetosupportthismodel. Whathasoccurredovertimewithinthisparadigmissomewhatanalogoustocommonlaw. Incommonlaw,decisionsarebasedonpastprecedentinlieuofspecificpolicyorstatute. Federalpharmacysystemshavedevelopedacommonpharmacypracticeacrossdecadesof implementationwhereithasbecomecommonandacceptedforpharmaciststofunctionas healthcareprovidersanddeliverdirectpatientcareservicesincollaborationwithphysicians basedonpositiveoutcomes.Althoughthiscollaborativepracticeisimplementedasa pragmaticsolutiontomeetsomeofthehealthcaredemandsandimprovedeliveryofcare,it isnotclearlydiscussedatthehighestlevelsofhealthleadershiporcorrectlyarticulatedin currentpharmacylegislationorcompensationstructures.ThisReportincludesobjectivesthat wouldacknowledgeandadvancethiscommonpharmacypracticeintheformofadvocacy, policy,andlegislation. ThePartnershiptoFightChronicDisease(PFCD)briefedtheSenateFinanceCommittee(SFC) regardingtheSFCshealthreformpaper,TransformingtheHealthCareDeliverySystem: ProposalstoImprovePatientCareandReduceHealthCareCosts.IntheletterdatedMay15, 2009,thePFCDstated,WithoutchangesinMedicarepaymentsanddeliverymodelsthat emphasizechronicdiseasepreventionandcontrol,wewillfailinoureffortstocontrol Medicarecostsandimprovethehealthofourpopulation.Alsointheletter,thePFCD recognizedandexemplifiedpharmacistsasoneofournationsprimaryhealthcare providers.111 ThroughouttheReport,arationalandlogicaljustificationhasbeenmadeforpharmaciststo helpbridgesomeofthegapsandneedsofourprimarycareandhealthcaresystems.Ithas beenexhaustivelydemonstratedthroughevidencebaseddatathatpharmacistswithinthese modelsofcareimproveoutcomesandcontaincosts.Organizations,academia,industry, community,hospital,andfederalpharmacycanandwillcontinuetodemonstratethepositive outcomesofitspharmacists.Pharmacistshaveevolvedasprovidersofcarebecauseitisthe rightthingtodoforpatientcareandthenationshealth. 46


Itisessentialthatadditionalfiscalandpolicysupportexistforthisparadigmshifttoallow pharmaciststocontinuetosustaintheseexpandedservicesandimproveoutcomes.Itistime toenactlegislationtorecognizeandcompensatepharmacistsreflectingachangeinthe pharmacypracticethathasalreadyoccurred.Thesechangeswillrapidlyansweraneedto improvethecosteffectiveness,quality,andaccesstoprimarycareandfurtheradvancethe healthofthenation. Giventhepracticeenvironmentandinnovativecaremodelsoffederalpharmacy,thenon federalsectorhashistoricallylookedtofederalpharmacytoassistinadvancingtheprofession. Federalpharmacyhaspioneeredmanyfacetsofservicedeliveryutilizingpharmaciststothe maximumextentoftheirlicensureandeducation.Duringthiseraofhealthreform,itisonce againnecessaryforPHSandfederalpharmacytoadvancethesesuccessfulandexistinghealth caredeliverymodelspastexplorationandintoimplementation.PHSPharmacyispoisedand capabletoassistthenationtowardtheoverallgoalofimprovedhealthcaredelivery. Thoseindecisionmakingpositions(inthefaceofdecadesofprovenperformance, interprofessionalsupportandevidencebasedoutcomes)mayneedtoconsiderexpanded implementationofthefullspectrumofpharmacistdeliveredpatientcareserviceswith appropriatepolicyandcompensatorymechanismsorclearlystatethebarriersofthis paradigmchangethathasdemonstratedimprovedhealthcaredelivery. DuringtheApril11,2011launchofthePartnershipsforPatientsInitiative,DonaldBerwick,CMS Administrator,stated,Americaisfacingacriticalchoiceinhealthcare.Eithercutcareor improvecare.Idontliketocutcare,sotheonlyrightthingtodoisimprovecare.10Oneofthe mostlogical,evidencebaseddecisionsthatcanbemadetoimprovecareistomaximizethe expertiseandscopeofpharmacists,andminimizeexpansionbarriersofanalreadyexistingand successfulhealthcaredeliverymodel. Iftheobjectivesofthispaperareactualized,theU.S.PublicHealthService,inpartnership withfederalpharmacyleadershipandtheOfficeoftheU.S.SurgeonGeneral,willdirectly supporthealthcaredeliveryimprovementandadvancethehealthofthenationwithanew paradigmforcare.

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APPENDICES A. NationalClinicalPharmacySpecialist(NCPS)Program B. OutcomesRepositorySpreadsheet C. U.S.CollaborativePracticeMap D. PhysicianSurvey

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AppendixA:NationalClinicalPharmacySpecialist(NCPS)Program Issue Fordecades,IndianHealthService(IHS)pharmacistshavepracticedinavarietyofexpanded andadvancedclinicalrolestoprovidepatientcare.IHSpharmacyiswidelyknown(inthe federalsector,privatesectorandacademia)foritsinnovativepharmacypractice,which includesprivilegesindiseasemanagement.InmanyIHSfacilities,itiscommonforpatientsto havepharmacistsprovidingfocusedmedicalcarethroughclinicvisitsverysimilartothatof otherprimarycareproviders.Withthisadvancedlevelofclinicalcareprovidedbypharmacists (throughexpandedscopesofpracticeagreementsapprovedbylocalfacilities),itisimportantto establishbestpractices,promoteuniformityamongcredentialsandcompetencies,andexplore appropriatereimbursementforservices.AsofDecember2008,thisuniformityextendsbeyond theIHSintotheBureauofPrisons(BOP)asaMemorandumofUnderstandingwassigned betweentheIHSandtheBOPtoexpandtheNCPSProgramintotheBOP. Purpose TheIHSestablishedanationalcredentialingsystemforIHS,Tribal,andUrban(I/T/U) pharmacistsinanefforttopromoteenhancedpatientoutcomesandaddressthefollowing: PromoteuniformclinicalcompetencyamongI/T/UandBOPpharmacists; DefineandrecognizeadvancedscopesofpracticeforI/T/UandBOPpharmacists; Establishcriticalelementsfordevelopingcollaborativepracticeagreements(CPAs); DevelopareviewprocesstoapproveCPAsandclinicalpharmacyspecialistsbyanational groupofsubjectmatterexpertstohelpensureuniformityofscopeandcompetencyboth locallyandnationally; Reviewcredentials,protocols,training,educationandexperienceofI/T/UandBOP pharmacists,andgrantNCPScertificationtorecognizeapharmacistslocalprivilegesthat meetthespecifiednationalstandardsforcredentialing; EstablishtheseelementstohelppromoteuniversalrecognitionofNCPSpharmacistsas billableproviders. Background TheOctober18,1996memorandumfromtheIHSDirectorestablishedIHSpharmacistsas primarycareproviders(PCPs)andallowsforprivilegestoincludeprescriptiveauthority.In responsetoagrowinginterestinclinicalpracticenationwide,andmeetingswithkey stakeholderssuchastheHealthCareFinancingAdministration(HCFA),theNCPSProgramand NCPSCommittee(NCPSC)wereestablishedbytheChiefPharmacyOfficerin1997and1998to provideamechanismtoassureallClinicalPharmacySpecialistsintheIHSdisplayauniform levelofcompetency.TheprovisionofadvancedpharmacycarefollowstheIHSPharmacy StandardsofPracticeasoutlinedinChapter7oftheIndianHealthManual.Withthisofficial chargeandhistoryofadvancedclinicalcarespanningover30years,thescopeofNCPScare includesallcriteriaandresponsibilitiescoveredintheIHSStandardsofPractice,aswellas focusedmanagementofdiseasestatesforselectedpatientsinwhommedicationsarethe principlemethodoftreatment.Patientcaremayincludeapatientinterview,chartreview,

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orderingandinterpretationoflaboratorytests,physicalassessment,prescriptiveauthority, formulationofclinicalassessments,anddevelopmentoftherapeuticplans,patienteducation, andpatientfollowup.Treatmentandmanagementareperformedthroughacollaborative practiceagreement(CPA)thathasbeenapprovedbythelocalmedicalstaff.Ifthepharmacistis acredentialedNCPS,theCPAhasalsobeenapprovedbytheNCPSC.NCPScertificationis intendedtouniformlyrecognizeanadvancedscopeofpracticelocallyaimedatmanagingone ormorediseasesand/oroptimizingspecificpharmacologictherapy.Pharmacistsmaypractice diseasemanagementatafacilityaftercompletinglocalrequirements,howeverNCPS certificationwillonlybegrantedaftersubmissionofanappropriateapplicationandfulfillment ofallnationalrequirements.Inordertopromoteuniformcompetencyandconsistencyinthe credentialingprocess,itisnowalsostronglyrecommendedthatallfacilitiesadopt,ata minimum,theNCPSstandardsforlocalcredentialingofpharmacistsinadvancedscopesof practice. Activity After13years,theprogramhasreviewedthecredentialsandcertified279I/T/Upharmacists from18states(approximately20percentofIHSpharmacists);directlyincreasedtheaccessto andqualityofprimarycarethroughcollaborativepracticeanddiseasemanagement.

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AppendixB:OutcomesRepositorySpreadsheet CITATION;
(PEERREVIEWED)

OUTCOMEVARIABLES
ImprovedClinicalOutcomes

RESULTS/CONCLUSIONS
Results:Symptomscoresimprovedinthe interventiongroupandmarginallyworsenedin thecontrolgroupto20.3(4.2)and28.1(3.5), respectively.Conclusions:Aselfmanagement programdeliveredbyacommunitypharmacist canimproveasthmacontrolinindividuals recruitedatacommunitypharmacy.Further studiesshouldattempttoconfirmthese findingsusinglargersamplesandawider rangeofoutcomemeasures.

BarbanelD.EldridgeS, etal.(2003).Cana selfmanagement programdeliveredby acommunity pharmacistimprove asthmacontrol?A randomizedtrial. Thorax58(10):8514. (YES)

Arandomizedcontrolledstudywas undertakentodeterminewhethera communitypharmacistcouldimprove asthmacontrolusingselfmanagement adviceforindividualsrecruitedduring attendanceatacommunitypharmacy. Methods:Twentyfouradultsattendinga communitypharmacyinTowerHamlets, eastLondonforroutineasthmamedication wererandomizedintotwogroups:the interventiongroupreceivedself managementadvicefromthepharmacist withweeklytelephonefollowupforthree monthsandthecontrolgroupreceivedno inputfromthepharmacist.Participants selfcompletedtheNorthofEngland asthmasymptomscaleatbaselineand threemonthslater.

Twentyfivestudiesincluded>40pharmacists and16,000patients.Scheduledservice utilizationwasslightlyincreased,andhospital admissionsandERadmissionsweredecreased. Pharmacistservicesdecreasedtheuseofnon scheduledhealthservices,thenumberof specialtyphysicianvisits,orthenumberand costsofdrugs,comparedtocontrolpatients (sixstudies).Improvementsintargetedpatient conditionwerereportedin10of13studies thatmeasuredpatientoutcomes,butpatients' qualityoflifedidnotseemtochange.All studiesdemonstratedthatpharmacist interventionsproducedtheintendedeffects onphysicians'prescribingpractices.

BeneyJ,BeroLA,Bond CochraneReviewofarticlesdiscussing C.Expandingtheroles pharmacistswithexpandedroles ofoutpatient pharmacists:effects onhealthservices utilization,costs,and patientoutcomes. CochraneDatabase SystRev 2000(3):CD000336

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CITATION;
(PEERREVIEWED)

OUTCOMEVARIABLES
Objective:Todemonstratethat pharmacists,workingcollaborativelywith patientsandphysiciansandhaving immediateaccesstoobjectivepointof carepatientdata,promotepatient persistenceandcompliancewith prescribeddyslipidemictherapythat enablespatientstoachievetheirNational CholesterolEducationProgram(NCEP) goals.Participants:26communitybased ambulatorycarepharmacies:independent, chainprofessional,chaingrocerystore, homehealth/homeinfusion,clinic,health maintenanceorganization/managedcare. Outcomemeasures:Ratesofpatient persistenceandcompliancewith medicationtherapyandachievementof targettherapeuticgoals.

RESULTS/CONCLUSIONS
Overanaverageperiodof24.6monthsandin 397patients,observedratesforpersistence andcompliancewithmedicationtherapywere 93.6%and90.1%respectively,and62.5%of patientshadreachedandweremaintainedat theirNCEPlipidgoalattheendoftheproject. Conclusion:Workingcollaborativelywith patients,physicians,andotherhealthcare providers,pharmacistswhohavereadyaccess toobjectiveclinicaldata,andwhohavethe necessaryknowledge,skillsandresources,can provideanadvancedlevelofcarethatresults insuccessfulmanagementofdyslipidemia.

BlumlBM,McKenney JM,CzirakyMJ.(2000). Pharmaceuticalcare servicesandresultsin projectImPACT: hyperlipidemia.JAm PharmAssoc 40(2):15765. (YES)

BogdenPE,KoontzLM, etal.Thephysician andpharmacistteam. Aneffectiveapproach tocholesterol reduction.JGenIntern Med1997;12(3):158 64.

Objective:Toassesstheeffectofa programthatencouragesteamwork betweenphysiciansandpharmacistson attemptstolowertotalcholesterollevels andtomeetrecommendedgoalsproposed bytheNationalCholesterolEducation Program(NCEP).Design:Singleblind, randomized,controlledtriallastingsix months.Setting:Anambulatoryprimary carecenter.Patients:Asampleof94 patientswithtotalcholesterollevelsof240 mg/dLorhigher.Intervention:Equal numbersofpatientswererandomly assignedtoacontrolarminwhich standardmedicalcarewasreceived,and aninterventionarmwhichimplemented closeinteractionbetweenphysiciansand pharmacists.

Results:TherateofsuccessinachievingNCEP goalsintheinterventionarmwasdoublethe rateinthecontrolarm(43%vs21%,P<.05). Totalcholesterollevelsintheinterventionarm declined44+/47mg/dLversus13+/51 mg/dLinthecontrolarm(p<.01).Aneffectof interventionwasabsentinpatientswithout coronaryheartdiseaseandwithfewerthan tworiskfactors.Conclusions:Attemptsto lowertotalcholesterollevelsandachieve NCEPgoalsarelikelytobemoresuccessful whencombinedwithprogramsthatinclude teamworkbetweenphysiciansand pharmacists.Someprograms,however,may bemoresuccessfulforhighriskpatients,for whomitisofteneasiertoprovidemore aggressivetherapies.Althoughaltering adverselipidprofilesinlowerriskpatients maybedifficult,achievingoptimalcholesterol levelscouldhaveanimportantimpacton preventingmovementtohigherriskstrata.

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CITATION;
(PEERREVIEWED)

OUTCOMEVARIABLES
Patientsineacharmwerefollowedfora minimumofsixmonths.Aprotocolfor therapychangesinclinicpatientswas developedbytheclinicalpharmacistand approvedbythecardiologist.

RESULTS/CONCLUSIONS
Attheendofsixmonths,69%ofpatientsin thepharmacistmanagedclinicachievedtheir LDLgoal,comparedwith50%ofcontrols. Compliancewithlaboratorytestsanddrug regimensalsoimprovedinclinicpatients. Compliancewithlipidpanelswentfrom8% twomonthsbeforeto89%twomonthsafter thestartofthestudy.Attheendofsix months,compliancewithlaboratoryworkand refillswas80%.Thustheclinicalpharmacist managedclinicwashighlysuccessfulin achievingNCEPgoalsforsecondary prevention.

BozovichM,Rubino CM,EdmundsJ.Effect ofaClinical PharmacistManaged LipidClinicon AchievingNational CholesterolEducation ProgramLowDensity LipoproteinGoals. Pharmacotherapy 2000;20(11):1375 1383. (YES)

Carson,J.J. Pharmacist coordinatedprogram toimproveuseof pharmacotherapyfor reducingriskof coronaryartery diseaseinlowincome adults.AmJHealth SystPharm 1999;56(22):231924. (YES)

Patientswerecategorizedassecondary prevention,orhighriskprimaryprevention ofcardiovasculardisease.Intervention: Thepharmacistmadepharmacotherapy recommendationsbasedonguidelines. Patients'useofaspirin,lipidlowering therapy,andHRTwasnotedbefore programentry.Useofthese pharmacotherapeuticmodalitieswasthen trackedthroughsubsequentvisits.In addition,thepatient'sbaselineserumlipid valueswererecordedandtracked.

Results:Insecondarypreventiongroup,mean LDLfellby26%(p<0.0001),and24(73%)of thepatientshadareductioninLDL concentration.Meantotalcholesterol concentrationamongsecondaryprevention patientsdecreasedby11%(p=0.007),andthe meanHDLconcentrationincreasedby19%(p <0.0001).Thepercentageofsecondary preventionpatientsachievingtheirNCEPLDL goalof<100mg/dLincreasedfrom6%to27% (p<0.04).Intheprimarypreventiongroup, themeanLDLconcentrationfellby27%(p< 0.0001),and29(71%)ofthepatientshada reductioninLDLconcentrationafterentryinto theprogram.Themeantotalcholesterol concentrationfellby15%(p=0.0002),andthe meanHDLconcentrationincreasedby12%(p =0.009).Thepercentageofpatientsachieving theirNCEPrecommendedLDLgoalof<130 mg/dLincreasedfrom20%to51%(p=0.006). Conclusion:Aprograminwhichapharmacist estimatedpatients'risksforcoronaryartery diseaseandrecommended pharmacotherapeuticinterventionsimproved theuseofthesepharmacotherapeutic modalitiesbylowincomeadults.

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CITATION;
(PEERREVIEWED)

OUTCOMEVARIABLES
Bloodpressurecontrol,qualityoflife, qualityofcare,andsatisfactionofpatients whoweremonitoredbyspeciallytrained communitypharmacistsinagroupmedical practicewasevaluated.Afterparticipating inanintensiveskilldevelopmentprogram, pharmacistsperformedinan interdisciplinaryteaminaruralclinic.The primaryobjectivewasassessedby evaluatingoutcomevariablesatsixmonths comparedwithbaselinein25patients randomlyassignedtoastudygroup.A controlgroupof26patientswasalso evaluatedtodetermineifoutcome variablesremainedconstantfrombaseline tosixmonths.

RESULTS/CONCLUSIONS
Results:Systolicbloodpressurewasreducedin thestudygroup(151mmHgbaseline,140 mmHgat6mo.,p<0.001)anddiastolicblood pressurewassignificantlylowerat2,4,and5 monthscomparedwithbaseline.Ratingsfrom ablindedpeerreviewpanelindicated significantimprovementinthe appropriatenessofthebloodpressure regimen,goingfrom8.7+/4.7to10.9+/4.5 inthestudygroup,buttheydidnotchangein thecontrolgroup.Severalqualityoflifescores improvedsignificantlyinthestudygroupafter sixmonths.Therewerenosignificantchanges inthecontrolgroup.Patientsatisfaction scoreswereconsistentlyhigherinthestudy groupattheendofthestudy.Resultsindicate thatwhencommunitypharmacistsinaclinic settingaretrainedandincludedasmembers oftheprimarycareteam,significant improvementsinbloodpressurecontrol, qualityoflife,andpatientsatisfactioncanbe achieved.

CarterBL,BarnetteDJ, etal.(1997). Evaluationof hypertensivepatients aftercareprovidedby community pharmacistsinarural setting. Pharmacotherapy 1997;17(6):127485. (YES)

CoastSeniorEA, KronerBA,KelleyCL, etal.Managementof patientswithtype2 diabetesby pharmacistsinprimary careclinics.Ann Pharmacother1998 Jun;32(6):63641.

Theobjectiveofthisstudywasto determinetheimpactofclinical pharmacistsinvolvedindirectpatientcare ontheglycemiccontrolofpatientswith type2diabetesmellitusintwoprimary careclinicsinauniversityaffiliated VeteransAffairsMedicalCenter.The pharmacistsprovideddiabeteseducation, medicationcounseling,monitoring,and insulininitiationand/oradjustments.All initialpatientinteractionswiththe pharmacistswerefacetoface.Thereafter, patientpharmacistinteractionswere eitherfacetofaceortelephonecontacts. Studysubjectswerepatientswithtype2 diabeteswhowerereferredtothe pharmacistsbytheirprimarycare providersforbetterglycemiccontrol. Primaryoutcomevariableswerechanges frombaselineinglycosylatedhemoglobin,

Twentythreeveteransaged6594years completedthestudy.Fifteen(65%)patients wereinitiatedoninsulinbythepharmacists eight(35%)werealreadyusinginsulin. PatientswerefollowedforameanSDof2710 weeks.Glycosylatedhemoglobin,fastingblood glucoseconcentrations,andrandomblood glucoseconcentrationssignificantlydecreased frombaselineby2.2%(p=0.00004),65mg/dL (p<0.01),and82mg/dL(p=0.00001) respectively.Symptomatichypoglycemic episodesoccurredin35%ofpatients.Noneof theseepisodesrequiredphysician intervention.Conclusion:Thisstudy demonstratedthatpharmacistsworkingas membersofinterdisciplinaryprimarycare teamscanpositivelyimpactglycemiccontrolin patientswithtype2diabetesrequiringinsulin.

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CITATION;
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OUTCOMEVARIABLES
fastingbloodglucose,andrandomblood glucosemeasurements.Secondary outcomeswerethenumberandseverityof symptomaticepisodesofhypoglycemia, andthenumberofemergencyroomvisits orhospitalizationsrelatedtodiabetes.

RESULTS/CONCLUSIONS

DolovichL,PottieK,et al.Integratingfamily medicineand pharmacytoadvance primarycare therapeutics.Clin PharmacolTher 2008;83(6):9137. (YES)

Pharmacistsplacedinsevenfamilypractice sitesinOntario,Canada.Physicians reviewedadviceprovidedbythe pharmacistsanddetermineda managementapproach.

Pharmacistsevaluated969patientsovera24 monthperiod.Pharmacistsidentifiedan averageof4.4drugrelatedproblemsper patient(3974total).Pharmacistsidentified adversedrugreactionsin241patients.

EllisSL,CarterBL, MaloneDC,etal. Clinicalandeconomic impactofambulatory careclinical pharmacistsin managementof dyslipidemiainolder adults:theIMPROVE study.Impactof Managed PharmaceuticalCare onResource Utilizationand OutcomesinVeterans AffairsMedical Centers. Pharmacotherapy 2000Dec;20(12):1508 16.

Thisstudyexaminedtheimpactof ambulatorycareclinicalpharmacist interventionsonclinicalandeconomic outcomesof208patientswith dyslipidemiaand229controlstreatedat nineVeteransAffairsmedicalcenters.This wasarandomized,controlledtrial involvingpatientsathighriskofdrug relatedproblems,thoughonlythosewith dyslipidemiaarereportedhere.Inaddition tousualmedicalcare,clinicalpharmacists wereresponsibleforproviding pharmaceuticalcareforpatientsinthe interventiongroup.Thecontrolgroupdid notreceivepharmaceuticalcare.Seventy twopercentoftheinterventiongroupand 70%ofcontrolsrequiredsecondary preventionaccordingtotheNational CholesterolEducationProgramguidelines.

Significantlymorepatientsintheintervention grouphadanimprovedfastinglipidprofile comparedwithcontrols.Theabsolutechange intotalcholesterol(17.7vs7.4mg/dl,p= 0.028)andlowdensitylipoprotein(23.4vs 12.8mg/dl,p=0.042)wasgreaterinthe interventionthaninthecontrolgroup.There werenodifferencesinpatientsachieving targetlipidvaluesorinoverallcostsdespite increasedvisitstopharmacists.Ambulatory careclinicalpharmacistscansignificantly improvedyslipidemiainapracticesetting designedtomanagemanymedicalanddrug relatedproblems.

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CITATION;
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OUTCOMEVARIABLES
Design:Oneyearprospective,randomized cohortstudyoftheoutpatientsofastate comprehensivehealthcentreinSouth westernNigeria.Freeprimaryhealth servicesincludingfreedrugswereprovided forallpatients.Methods:51Nigerian patientswithuncomplicatedhypertension aged45yearsormorewereincluded. Participatingpharmacistscounseledon currentmedication,personalizedgoalsof lifestylemodificationstressingweightloss and/orincreasedactivity,increasedpatient awarenessbyprovidingrelevanteducation abouthypertensionandassociated/related diseases,adjusteddrugtherapyto optimizeeffectivenessandminimize adverseevents,utilizedtreatment schedulesthatenhancedpatients' adherencetotherapy,andmonitored treatmentoutcomesbetweenenrollment andreturnvisits.Patientsatisfactionand thenumberoftreatmentfailureswithinsix monthspostenrollmentwerecompared withretrospectivedatafromanearlier studyinvolvingphysicianmanaged patientsunderasimilarsetting.

RESULTS/CONCLUSIONS
Results:UncontrolledBPreducedfrom92%to 36.2%by10.15+/5.02daysafterenrollment. Treatmentfailureswereobservedat5.9%of thetotalreturnvisits(n=184)withinsix months.Conclusion:Pharmacistmanaged hypertensionclinicscanimproveBPcontrol, reducetreatmentfailureandincreasepatient satisfaction.

ErhunWO,AgbaniEO, etal.Positivebenefits ofapharmacist managed hypertensionclinicin Nigeria.PublicHealth 2005;119(9):7928. (YES)

GattisWA,Hasselblad V,etal.Reductionin heartfailureeventsby theadditionofa clinicalpharmacistto theheartfailure managementteam: resultsofthe PharmacistinHeart FailureAssessment Recommendationand Monitoring(PHARM) Study.ArchInternMed 1999;159(16):1939 45. (YES)

181patientswithheartfailureandleft ventriculardysfunction(ejectionfraction <45)undergoingevaluationinclinicwere randomizedtoaninterventionoracontrol group.Patientsintheinterventiongroup receivedclinicalpharmacistevaluation, whichincludedmedicationevaluation, therapeuticrecommendationstothe attendingphysician,patienteducation,and followuptelemonitoring.Thecontrol groupreceivedusualcare.Theprimaryend pointwascombinedallcausemortality andheartfailureclinicalevents.

Results:Medianfollowupwassixmonths.All causemortalityandheartfailureeventswere significantlylowerintheinterventiongroup comparedwiththecontrolgroup(4vs16;P= 0.005).Inaddition,patientsintheintervention groupreceivedhigherangiotensinconverting enzyme(ACE)inhibitordosesasreflectedby themedianfractionoftargetreached(25th and75thpercentiles),1.0(0.5and1)and0.5 (0.1875and1)intheinterventionandcontrol groups,respectively(P<0.001).Theuseof othervasodilatorsinACEinhibitorintolerant patientswashigherintheinterventiongroup (75%vs26%;P=0.02).Conclusions:Outcomes inheartfailurecanbeimprovedwithaclinical pharmacistasamemberofthe

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OUTCOMEVARIABLES

RESULTS/CONCLUSIONS
multidisciplinaryheartfailureteam.This observationmaybeduetohigherdosesofACE inhibitorsand/orcloserfollowup.

GoodeJV,SwigerK,et al.Regional osteoporosis screening,referral, andmonitoring programincommunity pharmacies:findings fromProjectImPACT: Osteoporosis.JAm PharmAssoc(2003) 2004;44(2):15260. (YES)

Design:Singlecohortobservationalstudy ina29storepharmacychaininRichmond, VA.Participantswere532consumerswith oneormoreknownriskfactorsfor osteoporosisinthechain'scustomer servicearea.Intervention:Duringthe initialphase(healthpromotionanddisease prevention)oftheproject,pharmacy basedosteoporosisscreeningwithreferral andfollowupwasprovidedtoconsumers whorespondedtothechain'sscreening promotions.Thesecondphaseprovision ofcollaborativecommunityhealth managementservicesfocusedon osteoporosismonitoringandmanagement isongoingandincludespatientswhoare atriskforordiagnosedwithosteoporosis andarecoveredbyaregionalpayer. Outcomemeasures:Resultsofscreenings; responsesofpatientsandphysiciansto notifications;andlongtermresultsduring collaborativecare.

Results:305patientswereavailableforfollow upinterviewsthreetosixmonthslater.The stratificationforriskoffracturewas37%,high risk;33%,moderaterisk;and30%,lowrisk.A totalof78%ofpatientsindicatedtheyhadno priorknowledgeoftheirriskforfuture fracture.Inthemoderateandhighrisk categories,37%ofpatientsscheduledand completedaphysicianvisit,19%hada diagnosticscan,and24%ofthosepatients wereinitiatedonosteoporosistherapy subsequenttothescreening.Participating pharmaciesreceivedpaymentforboththe osteoporosisscreeningandthecollaborative healthmanagementservices.Conclusion: Pharmacistscanplayausefulroleinthe identification,education,andreferralof patientsatriskforosteoporosisthrough pharmacybasedBMDscreening.Patientsare willingtopayforpharmacybased osteoporosisscreeningservices.Thirdparty payersarewillingtocompensatepharmacists forcollaborativecommunityhealth managementservices.

HanlonJT,Weinberger M,SamsaGP,etal.A randomized, controlledtrialofa clinicalpharmacist interventionto improveinappropriate prescribinginelderly outpatientswith polypharmacy.AmJ Med1996 Apr;100(4):42837.

Thepurposewastoevaluatetheeffectof sustainedclinicalpharmacistinterventions involvingelderlyoutpatientswith polypharmacyandtheirprimary physicians.Methods:Randomized, controlledtrialof208patientsaged65 yearsorolderwithpolypharmacy(>or=5 chronicmedications)fromageneral medicineclinicofaVeteransAffairs MedicalCenter.Aclinicalpharmacistmet withinterventiongrouppatientsduringall scheduledvisitstoevaluatetheirdrug regimensandmakerecommendationsto themandtheirphysicians.Outcome

Results:Inappropriateprescribingscores declinedsignificantlymoreintheintervention groupthaninthecontrolgroupbythree monthsandwassustainedat12months. Fewerinterventionthancontrolpatients experiencedadversedrugevents.Measures formostotheroutcomesremainedunchanged inbothgroups.Physicianswerereceptiveto theinterventionandenactedchanges recommendedbytheclinicalpharmacistmore frequentlythantheyenactedchanges independentlyforcontrolpatients(55.1% versus19.8%;P<0.001).Conclusion:Aclinical pharmacistprovidingpharmaceuticalcarefor

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measureswereprescribing appropriateness,healthrelatedqualityof life,adversedrugevents,medication complianceandknowledge,numberof medications,patientsatisfaction,and physicianreceptivity.

RESULTS/CONCLUSIONS
elderlyprimarycarepatientscanreduce inappropriateprescribingandpossiblyadverse drugeffectswithoutadverselyaffecting healthrelatedqualityoflife.

JaberLA,HalapyH,et al.Evaluationofa pharmaceuticalcare modelondiabetes management.Ann Pharmacother 1996;30(3):23843. (YES)

Patientswererandomizedtoeithera pharmacistintervention(diabetes education,medicationcounseling, instructionsondietaryregulation,exercise, andhomebloodglucosemonitoring,and evaluationandadjustmentoftheir hypoglycemicregimen)orcontrolgroup (standardmedicalcareprovidedbytheir physicians)andfollowedovera4month period.Primaryoutcomemeasures:fasting plasmaglucoseandHbA1c.Secondary outcomes:bloodpressure,serum creatinine,creatinineclearance, microalbumintocreatinineratio,total cholesterol,triglycerides,HDL,andLDL.

Inthe39patientswhocompletedthestudy, significantimprovementinglycated hemoglobinandfastingplasmaglucosewas achievedintheinterventiongroup.Nochange inglycemiawasobservedinthecontrol subjects.Statisticallysignificantdifferencesin thefinalglycatedhemoglobinandfasting plasmaglucoseconcentrationswerenoted betweengroups.Conclusion:Thisstudy demonstratestheeffectivenessof pharmaceuticalcareinthereductionof hyperglycemiaassociatedwithnoninsulin dependentdiabetesmellitus(NIDDM)ina groupofurbanAfricanAmericanpatients.

JacksonSL,Peterson GM,etal.Improving theoutcomesof anticoagulation:an evaluationofhome followupofwarfarin initiation.JInternMed 2004;256(2):13744. (YES)

Anumberofstudieshavereportedtherisk ofbleedingassociatedwithwarfarinis highestearlyinthecourseoftherapy.This studyexaminedtheeffectofaprogram focusedonthetransitionofnewly anticoagulatedpatientsfromhospitalto thecommunity.Design:Openlabel randomizedcontrolledtrial.Setting: Homebasedfollowupofpatients dischargedfromacutecarehospitalin southernTasmania,Australia.Subjects: 128patientsinitiatedonwarfarinin hospitalandsubsequentlydischargedto generalpractitioner(GP)carewere enrolledinthestudy.Sixtywere randomizedtohomemonitoring(HM)and 68receivedusualcare(UC).Interventions: HMpatientsreceivedahomevisitbythe projectpharmacistandpointofcare internationalnormalizedratio(INR)testing

Results:Atdischarge,42%oftheHMgroup and45%oftheUCgrouphadatherapeutic INR.Atdayeight,67%oftheHMpatientshad atherapeuticINR,comparedwith42%ofUC patients(P<0.002).Inaddition,26%ofUC patientshadahighINR,comparedwithonly 4%ofHMpatients.Bleedingeventswere assessedthreemonthsafterdischargeand occurredin15%ofHMpatients,compared with36%oftheUCgroup(P<0.01). Conclusion:Thisprogramimprovedthe initiationofwarfarintherapyandresultedina significantdecreaseinhemorrhagic complicationsinthefirstthreemonthsof therapy.

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onalternatedaysonfouroccasions,with theinitialvisittwodaysafterdischarge. TheUCgroupwassolelymanagedbythe GPandonlyreceivedavisiteightdays afterdischargetodetermineanticoagulant control.

RESULTS/CONCLUSIONS

KaboliPJ,HothAB,et al.Clinicalpharmacists andinpatientmedical care:asystematic review.ArchIntern Med2006;166(9):955 64. (YES)

Purpose:toevaluatepublishedliterature ontheeffectsofinterventionsbyclinical pharmacistsonprocessesandoutcomesof careinhospitalizedadults.Methods:Peer reviewed,Englishlanguagearticleswere identifiedfromJanuary1,1985through April30,2005.Threeindependent assessorsevaluated343citations. Inpatientpharmacistinterventions selectediftheyincludedcontrolgroupand objectivepatientspecifichealthoutcomes; typeofintervention,studydesign,and outcomessuchasadversedrugevents, medicationappropriateness,andresource usewereabstracted.

Results:Thirtysixstudiesmetinclusion criteria,including10evaluatingpharmacists' participationonrounds,11medication reconciliationstudies,and15ondrugspecific pharmacistservices.Adversedrugevents, adversedrugreactions,ormedicationerrors werereducedin7of12trialsthatincluded theseoutcomes.Medicationadherence, knowledge,andappropriatenessimprovedin7 of11studies,whiletherewasshortened hospitallengthofstayinnineof17trials.No interventionledtoworseclinicaloutcomes andonlyonereportedhigherhealthcareuse. Improvementsinbothinpatientand outpatientoutcomemeasurementswere observed.Conclusions:Theadditionofclinical pharmacistservicesinthecareofinpatients generallyresultedinimprovedcare,withno evidenceofharm.Interactingwiththehealth careteamonpatientrounds,interviewing patients,reconcilingmedications,and providingpatientdischargecounselingand followupallresultedinimprovedoutcomes. Futurestudiesshouldincludemultiplesites, largersamplesizes,reproducible interventions,andidentificationofpatient specificfactorsthatleadtoimproved outcomes.

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Toclarifytheroleofpharmacistsinthe careofpatientswithheartfailure(HF),a systematicreviewwasperformed evaluatingtheeffectofpharmacistcareon patientoutcomesinHF.Methods:Asearch wasconductedonPubMed,MEDLINE, EMBASE,InternationalPharmaceutical Abstracts,WebofScience,Scopus, DissertationAbstracts,CINAHL,Pascal,and CochraneCentralRegisterofControlled Trialsforcontrolledstudiesfromdatabase inceptiontoAugust2007.Randomized controlledtrialsthatevaluatedtheimpact ofpharmacistcareactivitiesonpatients withHF(inbothInpatientandoutpatient settings)wereincluded.Summaryodds ratios(ORs)with95%confidenceintervals (CIs)werecalculatedusingarandom effectsmodelforratesofallcause hospitalization,HFhospitalization,and mortality.

RESULTS/CONCLUSIONS
Results:Atotalof12randomizedcontrolled trials(2060patients)wereidentified.Extentof pharmacistinvolvementvariedamongstudies, andeachstudyinterventionwascategorized aspharmacistdirectedcareorpharmacist collaborativecareusingaprioridefinitionsand feedbackfromprimarystudyauthors. Pharmacistcarewasassociatedwith significantreductionsintherateofallcause hospitalizations(11studies[2026patients]) andHFhospitalizations(11studies[1977 patients]),andanonsignificantreductionin mortality(12studies[2060patients]). Pharmacistcollaborativecareledtogreater reductionsintherateofHFhospitalizations thanpharmacistdirectedcare.Conclusions: Pharmacistcareinthetreatmentofpatients withHFgreatlyreducestheriskofallcause andHFhospitalizations.Sincehospitalizations associatedwithHFareamajorpublichealth problem,theincorporationofpharmacistsinto HFcareteamsshouldbestronglyconsidered.

KoshmanSL,Charrois TL,etal.Pharmacist careofpatientswith heartfailure:a systematicreviewof randomizedtrials. ArchInternMed 2008;168(7):68794. (YES)

LealS,HerrierRN, GloverJJ,FelixA. Improvingqualityof careindiabetes througha comprehensive pharmacistbased diseasemanagement program.Diabetes Care 2004;27(12):298384. (YES)

Pharmacistworkedunderacollaborative practiceagreementasthePCPfora diabeticpopulation;collaborationalso includedHTNandlipidmanagementin199 patients

SignificantdecreasesinHbA1c,LDL,total cholesterol,triglycerides,SBP,DBP,andblood glucose;"ptsmanagedbypharmacistwere morelikelytohaveattainedtreatmentgoals andhadrecommendedexaminations, medications,andtests"

LeeJ,McPhersonML. Outcomesof recommendationsby hospicepharmacists. AmJHealthSyst Pharm2006;63(22): 22359.(YES)

Purpose:Thevalueofpharmaceuticalcare recommendationsmadebyconsultant pharmacistsandtheoutcomesofthese recommendationswerestudied.Methods: Thestudywasconductedatthreehospice programs,andtheinvestigatorswere

Ninetyeightinterventionswerecollectedand evaluated.Eightysevenofthe98 interventionswereclassifiedasclinical interventionswithspecifictherapeuticgoals established.Ofthese87interventions,73 (84%)wereacceptedbytheprescriberand56

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consultantpharmacistswhosharedthe responsibilityofprovidingdrugtherapy recommendationstothethreeprograms. Aliteraturesearchwasconductedto determineifanytoolshadbeendeveloped toevaluaterecommendationsmadeby pharmacistsinclinicalpracticesettings. Onetoolwasidentifiedandadaptedfor useinahospiceclinicalsetting.Drug relatedproblems(DRPs)(n=98),clinical interventions(n=87),andoutcomesdata werecollectedbytwohospiceconsultant pharmacistsandevaluatedbyapanelof expertsusingtheassessmenttool.

RESULTS/CONCLUSIONS
(77%)outofthe73helpedachievethe therapeuticgoals.Anadditionalsix(8%) interventionspartiallyachievedthe therapeuticgoals.Over75%ofallofthe pharmacists'recommendationsachievedtheir intendedtherapeuticeffect,whichresultedin bettermanagementofthepatients'physical symptoms.Noneoftheaccepted recommendationsresultedinthepatient comingtoharmorhavinganadverseeffect. Overallagreementbetweenratersforseverity andvaluewasmoderatelyhigh,6070%and 6380%,respectively.Kappascoreswerelow. Conclusion:Hospicebasedclinicalpharmacists influencedpatientoutcomespositivelyby identifyingDRPsandrecommending appropriatedrugtherapy.

LiptonHL,BeroLA,et al.Theimpactof clinicalpharmacists' consultationson physicians'geriatric drugprescribing.A randomizedcontrolled trial.MedCare 1992;30(7):64658. (YES)

Theimpactofclinicalpharmacists' consultationsongeriatricdrugprescribing wasstudiedinaprospectiverandomized controlledtrialofpatients65yearsofage andoverdischargedonthreeormore medicationsforchronicconditionsfroma 450bedcommunityhospital.The pharmacistsprovidedconsultationto experimentalpatientsandtheirphysicians athospitaldischargeandatperiodic intervalsforthreemonthspostdischarge. Usingastandardizedtool,aphysician pharmacistpanel,blindedtostudygroup assignmentofpatients,evaluatedthe appropriatenessofprescribingfora randomsampleof236patients.

88%hadatleastoneormoreclinically significantdrugproblems,and22%hadat leastonepotentiallyseriousandlife threateningproblem.Drugtherapyproblems weredividedintosixcategories:1) inappropriatechoiceoftherapy;2)dosage;3) schedule;4)drugdruginteractions;5) therapeuticduplication;and6)allergy. Experimentalpatientswerelesslikelytohave oneormoreprescribingproblemsinanyofthe categories(P=0.05)orintheappropriateness (P=0.02)ordosage(P=0.05)categories.A summaryscore,measuringthe appropriatenessofthepatient'stotaldrug regimen,indicatedthatexperimentalpatients' regimensweremoreappropriatethanthoseof controls(P=0.01).Resultsofthistrialreveal thatclinicalpharmacistscanimprovethe appropriatenessofgeriatricdrugprescribingin outpatientsettings.

Diabeteseducationandmedication managementwerethemostfrequently utilizedinterventions.Significantreductionin HbA1cinpharmacistintervention

MachadoM,BajcarJ, Metaanalysisofpharmacistintervention GuzzoGC,EinarsonTR. indiabetesmanagement Sensitivityofpatient outcomesto

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RESULTS/CONCLUSIONS

Hypertensioneducationandmedication managementwerethemostfrequently utilizedinterventions.Significantreductionin systolicbloodpressure(BP)inpharmacist intervention

MachadoM,BajcarJ, Metaanalysisofpharmacistintervention GuzzoGC,EinarsonTR. inhypertensionmanagement Sensitivityofpatient outcomesto pharmacist interventions.PartII: systematicreviewand metaanalysisin hypertension management.Ann Pharmacother 2007;41:177081. (YES)

McKenneyJM,Slining JM,HendersonHR,et al.Theeffectofclinical pharmacyserviceson patientswithessential hypertension. Circulation1973 Nov;48(5):110411.

Comparedclinicalpharmacyservices providedto25studypatientsvs.25 controlpatientswithregardtoessential hypertension.

Results:Significantimprovementinnumberof studypatientswhosebloodpressure(BP)was keptwithinthenormalrangeduringthestudy period.Conclusion:Pharmacyclinicalservices arebeneficialandpharmacistsshouldbecome moreinvolvedinthelongtermcaregivento hypertensivepatients.

RadleyAS,HallJ,etal. Evaluationof anticoagulantcontrol inapharmacist operatedanti coagulantclinic.JClin Pathol1995;48(6):545 7. (YES)

Comparedpharmacistrunanticoagulation torotationmedicalseniorstaffrunclinic. Switchedfrommedicalstafftoseniorstaff inApril1992retrospectivestudyofthe fourmonthsbeforeandfourmonthsafter theswitch

Nocleardifferencebetweenpharmacistrun andmedicalstaffrunclinicsinthe382 patientswhowereanalyzed.Patientswithan INRresult"out"ofcontrollimitsweremore likelytobereturned"in"tocontrolattheir nextvisitbythepharmaciststhanbythe physicians.

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Physicianobtainedmedicationhistories werecomparedtothoseobtainedbya pharmacist.Methods:Patientswhose medicationhistorieswereobtainedwere includedintheevaluationiftheywereat least18yearsoldandadmittedtoan internalmedicineserviceattheUniversity ofVirginiaMedicalCenter.Datawere collectedintwophases.Thefirst20 patientsidentifiedforinclusionwereasked toprovideanaccuratemedicationhistory topilottestthemedicationhistoryform usedbythepharmacistandreceivedno pharmacistfollowuporinterventions.In thesecondphase,patientswereaskedto provideanaccuratemedicationhistory, andapharmacistintervenedwhen discrepanciesinthepharmacistobtained medicationhistorywereidentified.

RESULTS/CONCLUSIONS
Results:Atotalof55patientswereincludedin thestudy.Thepharmacistsidentified614 medicationsforthesepatients,comparedwith 556identifiedbythephysicians(p<or= 0.001).Thepharmacistdocumented significantlymoremedicationdosesand dosageschedulesthandidphysicians(614 versus446and614versus404,respectively)(p <or=0.001forbothcomparisons).The pharmacistidentified353discrepancies, including58medicationsnotinitiallyidentified fromthephysicianobtainedhistories.The pharmacistintervenedfor161discrepancies, correcting142aftercontactingtherespective physician;19medicationdiscrepanciescould notbejustifiedbythephysician.Conclusion:A totalof353discrepancieswereidentified whenmedicationhistoriesobtainedby physicianswerecomparedwiththose obtainedbyapharmacistduringthestudy. Duringtheinterventionphase,themajorityof discrepanciesidentifiedwereeithercorrected bythepharmacistaftercontactingthe respectivephysicianorjustifiedbythe physician.

ReederTA,MutnickA. Pharmacistversus physicianobtained medicationhistories. AmJHealthSyst Pharm 2008;65(9):85760. (YES)

RosenCE,CoppWM, HolmesS. Effectivenessofa speciallytrained pharmacistinarural communitymental healthcenter.Public HealthRep 1978:93(5);4647. (YES)

Comparedpharmacistprovidedcarewith psychiatristprovidedcaretomentalhealth patientsineightclinicsoverathreeyear period.

Patientsinthepharmacistgroupreported beingsignificantlyhealthiersincecomingto theclinicthandidotherpatients;also reportedneedingsignificantlylessadditional helpthandidtheotherpatients.

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Primarycarebaseddiabetesdisease managementprogramforpatientswith type2diabetesandpoorglucosecontrol. Pharmacistsofferedsupporttopatients withdiabetesthroughdirectteaching aboutdiabetes,frequentphonefollowup, medicationalgorithms,anduseofa databasethattrackedpatientoutcomes andactivelyidentifiedopportunitiesto improvecare.

RESULTS/CONCLUSIONS
Afteranaverageofsixmonthsofintervention, themeanreductioninHbA1cwas1.9 percentagepointsinthe138patientswho completedthestudy.Inconclusion,a pharmacistbaseddiabetescareprogram integratedintoprimarycarepractice significantlyreducedHbA1camongpatients withdiabetesandpoorglucosecontrol.

RothmanR,MaloneR, etal.Pharmacistled, primarycarebased diseasemanagement improveshemoglobin A1cinhighrisk patientswithdiabetes. AmJMedQual 2003;18(2):518. (YES)

SadikA,YousifM,et al.Pharmaceutical careofpatientswith heartfailure.BrJClin Pharmacol 2005;60(2):18393. (YES)

Objective:Investigatetheimpactofa pharmacistledpharmaceuticalcare program,involvingoptimizationofdrug treatmentandintensiveeducationand selfmonitoringofpatientswithheart failure(HF)withintheUnitedArab Emirates(UAE),onarangeofclinicaland humanisticoutcomemeasures.Methods: Randomized,controlled,longitudinal, prospectiveclinicaltrialofHFpatients. Interventionpatientsreceivedastructured pharmaceuticalcareservicewhilecontrol patientsreceivedtraditionalservices. Patientfollowuptookplacewhenpatients attendedscheduledoutpatientclinics (everythreemonths).Atotalof104 patientsineachgroupcompletedthetrial (12months).Thepatientsweregenerally sufferingfrommildtomoderateHF(NYHA Class1,29.5%;Class2,50.5%;Class3, 16%;andClass4,4%).

Results:Interventionpatientsshowed significantimprovementsinarangeof summaryoutcomemeasuresincluding exercisetolerance,forcedvitalcapacity, healthrelatedqualityoflife,asmeasuredby theMinnesotalivingwithheartfailure questionnaire.Thenumberofindividual patientswhoreportedadherenceto prescribedmedicationswashigherinthe interventiongroup(85vs.35),aswas adherencetolifestyleadvice(75vs.29)atthe finalassessment(12months).Therewasa tendencytohaveahigherincidenceof casualtydepartmentvisitsbyintervention patients,butalowerrateofhospitalization. Conclusion:Theresearchprovidesclear evidencethatthedeliveryofpharmaceutical caretopatientswithHFcanleadtosignificant clinicalandhumanisticbenefits.

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Purpose:Outcomesofpharmacist manageddiabetescareinacommunity healthcenterwerestudied.Methods: Eligiblepatientsoverage18yearswith diagnosisoftype2diabetesmellitus, randomlyassignedbytheclinical pharmacistandnursetointervention(n= 76)orcontrolgroup(n=73).Patientsin theinterventiongroupwereenrolledina pharmacistmanageddiabetescare program.Patientsinthecontrolgroup receivedthestandarddiabetescare.The primaryendpointwasreductioninHbA1c; secondaryoutcomemeasuresincluded weightloss,animprovedbodymassindex, decreasedbloodpressure,andan improvedlipidpanel.Qualityoflife measures(healthlevel,satisfaction, impact,worryaboutdisease,andworry aboutsocialandvocationalissues)were alsoassessed.

RESULTS/CONCLUSIONS
Results:MeanHbA1clevelsfellsignificantly frombaselinetoninemonthsinbothgroups. Adifferenceof1.0wasreportedbetweenthe groups'HbA1clevels.Satisfactionlevel improvedfrom63.7to77.4intheintervention group,whichwassignificantwhencompared withthecontrolgroup,whosesatisfaction scoreimprovedfrom57.0to63.4(p<0.05). Conclusion:Patientswithtype2diabetes mellituswhoreceivedpharmacistmanaged diabetescaredemonstratedimprovedHbA1c, systolicbloodpressure,andlowdensity lipoproteincholesterollevelsandqualityof lifemeasuresandmettreatmentgoalsmore oftenthanpatientsreceivingstandardcare.

ScottDM,BoydST,et al.Outcomesof pharmacistmanaged diabetescareservices inacommunityhealth center.AmJHealth SystPharm 2006;63(21):211622. (YES)

SookaneknunP, RichardsRM,etal. Pharmacist involvementin primarycareimproves hypertensivepatient clinicaloutcomes.Ann Pharmacother 2004;38(12):20238. (YES)

Objective:Toevaluatetheeffectof pharmacistinvolvementintreatmentwith hypertensivepatientsinprimarycare settings.Methods:Thetreatmentobjective wastostabilizethebloodpressure(BP)of hypertensivepatientsinaccordancewith theJointNationalCommitteeon Prevention,Detection,Evaluationand TreatmentofHighBloodPressure guidelines.Patientswererandomly assignedtoapharmacistinvolvedgroup (treatment)oragroupwithnopharmacist involvement(control).Preandposttest BPs,tabletcounts,lifestylemodifications, andpharmacists'recommendationswere recorded.The6monthstudywascarried outinMahasarakhamUniversitypharmacy andtwoprimarycareunits.Patientswere monitoredmonthlybyreviewingtheir medicationsandsupportedbyproviding pharmaceuticalcareandcounseling.

Results:Fromatotalof235patients,the treatmentgroup(n=118)hadasignificant reductioninbothsystolic(S)anddiastolic(D) BPcomparedwiththe117patientsofthe controlgroup.The158patients(76treatment, 82control)withBPs>or=140/90mmHgat thebeginningofthestudyshowedsignificant BPreductions.Theproportionof158patients whoseBPbecamestabilizedwashigherinthe treatmentgroup.Thetreatmentgroupshowed significantlybetteradherenceandexercise controlattheendofthestudy.Physicians accepted42.72%ofmedicationmodifications and5.34%ofthesuggestionsforadditional investigations.Conclusion:Hypertensive patientswhoreceivedpharmacistinput achievedasignificantlygreaterbenefitinBP reduction,BPcontrol,andimprovementin adherencerateandlifestylemodification.

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Design:Randomizedcontrolledtrialat36 communitydrugstoresinIndianapolis, Indiana,including898participantswith asthmaoractivechronicobstructive pulmonarydisease(COPD)over12 months.Interventions:Thepharmaceutical careprogramprovidedpharmacistswith recentpatientspecificclinicaldata(peak expiratoryflowrates[PEFRs],emergency department[ED]visits,hospitalizations, andmedicationcompliance),training, customizedpatienteducationalmaterials, andresourcestofacilitateprogram implementation.ThePEFRmonitoring controlgroupreceivedapeakflowmeter, instructionsaboutitsuse,andmonthly callstoelicitPEFRs.However,PEFRdata werenotprovidedtothepharmacist. Patientsintheusualcaregroupreceived neitherpeakflowmetersnorinstructions intheiruse;duringmonthlytelephone interviews,PEFRrateswerenotelicited. Outcomemeasures:Peakexpiratoryflow rates,breathingrelatedEDorhospital visits,healthrelatedqualityoflife (HRQOL),medicationcompliance,and patientsatisfaction.

RESULTS/CONCLUSIONS
Results:At12months,patientsreceiving pharmaceuticalcarehadsignificantlyhigher peakflowratesthantheusualcaregroupbut nothigherthanPEFRmonitoringcontrols.No significantbetweengroupdifferencesin medicationcomplianceorHRQOL.Asthma patientsreceivingpharmaceuticalcarehad significantlymorebreathingrelatedEDor hospitalvisitsthantheusualcaregroup. Patientsreceivingpharmaceuticalcarewere moresatisfiedwiththeirpharmacistthanthe usualcaregroupandthePEFRmonitoring group,andweremoresatisfiedwiththeir healthcarethantheusualcaregroupatsix monthsonly.Despiteampleopportunitiesto implementtheprogram,pharmacistsaccessed patientspecificdataonlyabouthalfofthe timeanddocumentedactionsabouthalfof thetimethatrecordswereaccessed. Conclusion:Thispharmaceuticalcareprogram increasedpatients'PEFRscomparedwithusual carebutprovidedlittlebenefitcomparedwith peakflowmonitoringalone.Pharmaceutical careincreasedpatientsatisfactionbutalso increasedtheamountofbreathingrelated medicalcaresought.

WeinbergerM, MurrayMD,etal. Effectivenessof pharmacistcarefor patientswithreactive airwaysdisease:a randomizedcontrolled trial.JAMA 2002;288(13):1594 602. (YES)

YamadaC,JohnsonJA, etal.Longterm impactofa communitypharmacist interventionon cholesterollevelsin patientsathighrisk forcardiovascular events:extended followupofthe secondstudyof cardiovascularrisk interventionby pharmacists(SCRIP plus).

Objective:Determinetheeffectofa communitypharmacistinterventionin patientsathighriskforcoronaryheart diseaseonLDLlevelsoneyearafter completionoftheSecondStudyof CardiovascularRiskInterventionby Pharmacists(SCRIPplus).Methods: Patientswhocompletedtheoriginalstudy wereinvitedtomakeasinglereturnvisit totheircommunitypharmacysothe pharmacistcouldmeasuretheirfastingLDL levelusingapointofcaredevice.The primaryoutcomewaschangeinLDLlevel fromthe6month(final)visittothe extendedfollowupevaluation.

Results:Datawerecollectedfor162patients. Themean+/SDLDLlevelatcompletionofthe originalstudywas107.9+/33.6mg/dl.Sixty one(38%)patientswereatthetargetLDLlevel (<96.7mg/dl).Conclusion:TheLDLreduction wasmaintainedoneyearaftercompletionof theextendedfollowup.Sincemostpatients werestillnotatthetargetLDLlevel,this findingsuggeststhatcontinuinginterventionis necessarytohelppatientsreachthistarget.

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RESULTS/CONCLUSIONS

ImprovedClinicalOutcomesANDCostReduction

BondCA,MonsonR. Sustained improvementindrug documentation, compliance,and diseasecontrol.A fouryearanalysisof anambulatorycare model.ArchIntern Med1984 Jun;144(6):115962.

Theeffectivenessofanintervention programinvolvingaclinicalpharmacistand nurseclinicianinimprovingdrug documentationinmedicalrecords,patient compliance,anddiseasecontrolwas analyzed.Medicalrecordsandprescription fileswerereviewedforpatientsina rheumatologyandrenalclinic.Compliance wasestimatedbyexaminingprescription refillpatterns.Reviewswereperformed beforeintervention(controlgroup),nine monthsafterintervention(studygroup1), andfouryearsandninemonthsafterthe interventionprogrambegan(studygroup 2).

Asixmonthretrospectiveanalysisateach reviewpointdemonstratedasignificant improvementindrugdocumentation, compliance,anddiseasecontrol(BP)forboth studygroups.Costreductionsassociatedwith theinterventionprogramsuggestthatthis programiscosteffective.

BuntingBA,Cranor CW.(2006).The AshevilleProject:long termclinical, humanistic,and economicoutcomesof acommunitybased medicationtherapy managementprogram forasthma.JAm PharmAssoc(2003) 2006;46(2):13347. (YES)

Intervention:regularlongtermfollowup of207adultpatientswithasthmaby pharmacists(reimbursedformedication therapymanagement[MTM]byhealth plans)usingscheduledconsultations, monitoringandrecommendationsto physicians.Outcomesincludedchangesin forcedexpiratoryvolumeinonesecond (FEV1),asthmaseverity,symptom frequency,thedegreetowhichasthma affectedpeople'slives,presenceofan asthmaactionplan,asthmarelated emergencydepartment/hospitalevents, andchangesinasthmarelatedcostsover time.

Allobjectiveandsubjectivemeasuresof asthmacontrolimprovedandweresustained foraslongasfiveyears.FEV1andseverity classificationimprovedsignificantly.Spending onasthmamedicationsincreased;however, asthmarelatedmedicalclaimsdecreasedand totalasthmarelatedcostsweresignificantly lowerthantheprojectionsbasedonthestudy population'shistoricaltrends.Directcosts savingsaveraged$725/pt/yrandindirectcost savingswereestimatedtobe$1230/pt/yr. Indirectcostsduetomissed/nonproductive workdaysdecreasedfrom10.8days/yearto 2.6days/yr.Patientsweresixtimeslesslikely tohaveanED/hospitalizationeventafter programinterventions.Conclusion:patients withasthmawhoreceivededucationandlong termmedicationtherapymanagement servicesachievedandmaintainedsignificant improvements,andhadsignificantlydecreased overallasthmarelatedcostsdespiteincreased medicationcoststhatresultedfromincreased

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use.

RESULTS/CONCLUSIONS
Datafrom620patientsinthefinancialcohort and565patientsintheclinicalcohortwere analyzed.SeveralindicatorsofCVhealth improvedoverthestudymeanSBP,mean DBP,percentageofpatientsatBPgoal, loweredmeanLDL,percentageofptsatLDL cholesterolgoal,loweredmeantotal cholesterolandmeanserumtriglycerides.The CVeventratedeclinedbyalmostonehalf duringthestudyperiod.MeancostperCV eventwas$9,931vs.$14,343.CVmedication useincreasedthreefold,butCVrelated medicalcostsdecreasedby46.5%.CVrelated medicalcostsdecreasedfrom30.6%oftotal healthcarecoststo19%.A53%decreasein riskofaCVeventandgreaterthan50% decreaseinriskofaCVrelatedED/hospital visitwerealsoobserved.Conclusions:Patients withHTNand/ordyslipidemiareceiving educationandlongtermMTMservices achievedsignificantclinicalimprovementsthat weresustainedforaslongassixyears;a significantincreaseintheuseofCV medications,andadecreaseinCVeventsand relatedmedicalcosts.

BuntingBA,SmithBH, etal.TheAsheville Project:clinicaland economicoutcomesof acommunitybased longtermmedication therapymanagement programfor hypertensionand dyslipidemia.JAm PharmAssoc(2003) 2008;48(1):2331. (YES)

Objective:Assessclinicalandeconomic outcomesofacommunitybased,long termmedicationtherapymanagement (MTM)programforhypertension (HTN)/dyslipidemiaovera6yearperiod. Interventions:Cardiovascularor cerebrovascular(CV)riskreduction education;regular,longtermfollowupby pharmacists(reimbursedbyhealthplans) usingscheduledconsultations,monitoring, andrecommendationstophysicians.Main outcomemeasureswereclinicaland economicparameters.

ChiquetteE,Amato MG,BusseyHI. Comparisonofan anticoagulationclinic withusualmedical care:anticoagulation control,patient outcomes,andhealth carecosts.ArchIntern Med1998Aug10 24;158(15):16417.

Theobjectivewastocomparenewly anticoagulatedpatientswhoweretreated withusualmedicalcare(generalmedicine physicians)withthosetreatedbyaclinical pharmacistatananticoagulationclinic(AC) forpatientcharacteristics,anticoagulation control,bleedingandthromboembolic events,anddifferencesincostsfor hospitalizationsandemergency departmentvisits.

Results:Whencomparedtousualmedicalcare (UMC),patientstreatedattheanticoagulation clinic(AC)hadfewerinternationalnormalized ratiosgreaterthan5.0,spentmoretimein range,spentlesstimeataninternational normalizedratiogreaterthan5,andhadfewer internationalnormalizedratioslessthan2.0. TheACgrouphadlowerratesofsignificant bleeding,majortofatalbleeding,and thromboembolicevents.TheACgroupalso demonstratedatrendtowardalower mortalityrate.Significantlylowerannualrates ofwarfarinrelatedhospitalizationsand emergencydepartmentvisitsreducedannual healthcarecostsby$13,2086per100

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RESULTS/CONCLUSIONS
patients.Additionally,alowerrateofwarfarin unrelatedemergencydepartmentvisits producedanadditionalannualsavingsin healthcarecostsof$2,972per100patients. Conclusion:AclinicalpharmacistrunAC improvedanticoagulationcontrol,reduced bleedingandthromboemboliceventrates,and saved$162,058per100patientsannuallyin reducedhospitalizationsandemergency departmentvisits.

CranorCW,Bunting BA,ChristensenDB. TheAshevilleProject: longtermclinicaland economicoutcomesof acommunity pharmacydiabetes careprogram.JAm PharmAssoc 2003;43(2):17384. (YES)

Changesinglycosylatedhemoglobin(A1c) andserumlipidconcentrations,changesin diabetesrelatedandtotalmedicaluse, costsovertime.

MeanA1cdecreasedatallfollowups,more than50%ofpatientsdemonstrated improvementsateachfollowup,numberof patientswithoptimalA1cincreasedateach followup,and>50%improvedinlipidlevels. Costsshiftedfrominpatientandoutpatient servicesfromphysicianstoprescriptions, meandirectmedicalcostsdecreasedby $1,200to$1,872perpatientperyear,andsick daysdecreasedforoneemployergroup,with increasesinproductivityestimatedat$18,000 annually.

CranorCW, ChristensenDB.The AshevilleProject: shorttermoutcomes ofacommunity pharmacydiabetes careprogram.JAm PharmAssoc 2003;43(2):14959. (YES)

Assessmentofshorttermclinical, economic,andhumanisticoutcomesof pharmaceuticalcareservices(PCS)for85 patientswithdiabetesincommunity pharmacies.Pharmacistsprovided education,selfmonitoredbloodglucose (SMBG)metertraining,clinicalassessment, patientmonitoring,followup,andreferral overseventoninemonths.Outcomes: Changefrombaselineinthetwoemployer groupsinglycosylatedhemoglobin(A1c) values,serumlipidconcentrations,health relatedqualityoflife(HRQOL),satisfaction withpharmacyservices,andhealthcare utilizationandcosts.

Results:A1cconcentrationsweresignificantly reduced.Significantdollars52perpatientper monthincreaseindiabetescosts,withPCS feesanddiabetesprescriptionsaccountingfor mostoftheincrease.Patientsexperienceda nonsignificantbuteconomicallyimportant 29%decreaseinnondiabetescostsanda16% decreaseinalldiagnosiscosts.Conclusion:A cleartemporalrelationshipwasfound betweenPCSandimprovedA1c,improved patientsatisfactionwithpharmacyservices, anddecreasedalldiagnosiscosts.Findings fromthisstudydemonstratepharmacists providedeffectivecognitiveservicesand refutetheideathatpharmacistsmustbe certifieddiabeteseducatorstohelppatients withdiabetesimproveclinicaloutcomes.

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Purpose:Theclinicalandfinancial outcomesofapainclinicmanagedbya pharmacistwithprescribingauthorityare described.Summary:Pharmacistclinicians inaforprofit,integratedhealthsystem recentlyreceivedpermissiontobillfor theirservicesincertainambulatoryclinics. Apharmacistclinician,whohadan individualDEAnumberandwhoseservices arebillableunderNewMexicolaw,was chosentoassumethemedication managementresponsibilitiesinaclinic where90%ofthepatientpopulationis treatedforchronicnoncancerrelated pain.Noadditionalpersonnelwere needed,andnoadditionalspacewas required,eliminatingoverheadforthe spaceandutilitiesneededforoperatinga clinic.Therevenuegeneratedwastracked byamedicalbillingsystem,andclinical outcomesweretrackedusingtheclinic's databaseforpatients'individualvisual analoguescale(VAS)painscores.

RESULTS/CONCLUSIONS
Withtheabilitytobillforthepharmacist clinician'sservices,anewmodelfor justificationofclinicalpharmacyserviceswas developedfortheambulatorycareclinics. BetweenJune2004andJune2005,anaverage of18patientswasseenbythepharmacist clinicianeachday.Theclinicgenerated $107,550ofactualrevenueandsavedthe healthplanover$450,000.Therewasa consistentdecreaseinmeanVASpainscores withcontinuedvisits.Conclusion:Patientswith chronicnoncancerrelatedpainwere managedeffectivelybyapharmacistwith prescribingauthorityandrefillauthorizationin apainmanagementclinic.Thefavorable clinicaloutcomes,revenuegenerated,andcost savingsachievedjustifiedthepharmacist clinician'sservicesinthishealthsystem.

DoleEJ,Murawski MM,etal.Provisionof painmanagementbya pharmacistwith prescribingauthority. AmJHealthSyst Pharm2007;64(1):85 9. (YES)

FarrisKB,KumberaP, etal.Outcomesbased pharmacist reimbursement: reimbursing pharmacistsfor cognitiveservicespart 1.JManagCare Pharm2002;8(5):383 93. (YES)

Methods:Acrosssectionaldescriptive studywascompletedusingtheclaims submittedbypharmaciststosummarize findingsfromthefirstyearofoperationsof thisoutcomesbasedpharmacist reimbursementprogram(OBPR).The programinvolvedcollaborationbetween pharmacybenefitmanagers(PBMs)and communitypharmaciststoimprove medicationuse.Pharmacistswere reimbursedfor(1)convertingtherapeutic regimenstogenericdrugsorpreferred formularymedicationswhenaprescriber contactisrequired;(2)conductingpatient educationandfollowupafterinitiationof newmedications,changesindrugtherapy, orfollowinganoverthecounter(OTC) consultation;and(3)resolvingdrug therapyproblems.Anefficient,nocost

Results:Dataanalysisforthefirstyearof operation,July1,2000,throughJune30,2001, showed11,326enrolleesobtained124,768 prescriptions.Themajorityofindividuals(n= 8335,74%)receivedsomeintervention service.Themajority(90%)ofintervention serviceswerepatienteducationandfollowup onnewprescriptionsorchangesin prescriptions.Morethan200individualshad drugrelatedproblems.Conclusion:This uniquesystemofoutcomesbasedpharmacist reimbursementpermitscommunity pharmaciststodocumentandbillforcognitive services.IthasdemonstratedthatPBMsand communitypharmacistscanworktogetherto improvedrugtherapy,anditmayreduce healthcarecosts.

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billingsystemwascreated.Themain outcomemeasuresweredescriptive statisticsofprescriptions,intervention claims,andpharmacistparticipationinthe program.Frequencydistributionsand descriptivestatisticswereusedto summarizethefirstyearofclaims.

RESULTS/CONCLUSIONS

GarrettDG,BlumlBM. Patientself managementprogram fordiabetes:firstyear clinical,humanistic, andeconomic outcomes.JAmPharm Assoc(2003) 2005;45(2):1307. (YES)

Objective:Assesstheoutcomesforthe firstyearfollowingtheinitiationofa multisitecommunitypharmacycare services(PCS)programfor256patients withdiabetes.Interventions:Community pharmacistpatientcareservicesusing scheduledconsultations,clinicalgoal setting,monitoring,andcollaborativedrug therapymanagementwithphysiciansand referralstodiabeteseducators.Outcomes: ChangesinHbA1c;LDL;BP;flu vaccinations;footscreens;eyeexams; patientgoalsfornutrition,exercise,and weight;patientsatisfaction;andchangesin medicalandmedicationutilizationand costs.

Results:Overtheinitialyearoftheprogram, participants'meanA1Cdecreasedfrom7.9% atinitialvisitto7.1%,meanLDLCdecreased from113.4mg/dLto104.5mg/dL,andmean systolicbloodpressureddecreasedfrom136.2 mmHgto131.4mmHg.Duringthistime, influenzavaccinationrateincreasedfrom52% to77%,theeyeexaminationrateincreased from46%to82%,andthefootexamination rateincreasedfrom38%to80%.Patient satisfactionwithoveralldiabetescare improvedfrom57%ofresponsesinthe highestrangeatbaselineto87%atthislevel after6months,and95.7%ofpatients reportedbeingverysatisfiedorsatisfiedwith thediabetescareprovidedbytheir pharmacists.Totalmeanhealthcarecostsper patientwere$918lowerthanprojectionsfor theinitialyearofenrollment.Conclusion: Patientswhoparticipatedintheprogramhad significantimprovementinclinicalindicators ofdiabetesmanagement,higherratesofself managementgoalsettingandachievement, andincreasedsatisfactionwithdiabetescare, andemployersexperiencedadeclineinmean projectedtotaldirectmedicalcosts.

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Thisprospective,randomizedtrial investigatedwhetherasingleconsultation byaclinicalpharmacistwithhighrisk patientsandtheirprimaryphysicians wouldresultinimprovedprescribing outcomes.Patientsatriskformedication relatedproblemswereidentifiedand randomizedtoreceiveapharmacotherapy consultation(consultgroup)orusual medicalcare(controlgroup).Outcomes, includingthenumberofdrugs,numberof dosesperday,costofmedications,and patientreportsofadverseeffects,were recordedatbaselineandatsixmonths followingtheintervention.

RESULTS/CONCLUSIONS
Results:Fiftysixsubjectswereevaluable:29in thecontrolgroup,and27intheconsultgroup. Sixmonthsaftertheconsultation,thenumber ofdrugs,thenumberofdoses,andthe6 monthdrugcostsalldecreasedintheconsult groupandincreasedinthecontrolgroup;the netdifferencewas1.1drugs(P=0.004),2.15 dosesperday(P=0.007),$586peryear(P= 0.008).Thesideeffectsscoreimprovedby1.8 pointsmoreintheconsultgroupcompared withthecontrolgroup(P=notsignificant). Similarly,theprescribingconveniencescorein theconsultgroupimprovedby1.4pointsmore thanthatofthecontrolgroup(P=not significant).Conclusions:Thisstudy demonstratedseveralimportantbenefitsof integrationofaclinicalpharmacistintoa primarycaresetting,includingimprovementin costandsimplificationofthemedication regimenwithnoreductioninqualityofcare.

JamesonJ,VanNoord G,etal.Theimpactof apharmacotherapy consultationonthe costandoutcomeof medicaltherapy.JFam Pract1995;41(5):469 72. (YES)

JohnstonAM,Doane K,PhippsK,BellA. Outcomesof pharmacists'cognitive servicesinthelong termcaresetting. ConsPharm 1996;11(1):4150. (YES)

Outcomemeasures:Numberandtypeof interventions,changeindrugtherapy, changeinmedicationcost,changein patienthealth.

Pharmacistsmade3,464interventions. Responserateforinterventionsrequestinga responsewas85.7%,witha68%acceptance rate.Acceptedrecommendationsresultedina totalcostsavingsof$15,111.38forthe1 monthperiod.Acceptedrecommendations resultedinfavorablehealthoutcomes99.5% ofthetime.

McLeanW,GillisJ,et al.TheBCCommunity PharmacyAsthma Study:Astudyof clinical,economicand holisticoutcomes influencedbyan asthmacareprotocol providedbyspecially trainedcommunity pharmacistsinBritish

Objectives:Thestudyincorporatedacare protocolwithasthmaeducationon medications,triggers,selfmonitoringand anasthmaplan,withpharmaciststaking responsibilityforoutcomes,assessmentof apatient'sreadinesstochangeand tailoringeducationtothatreadiness, compliancemonitoringandphysician consultationtoachieveasthmaprescribing guidelines.Methods:Thirtythree pharmacistsinBritishColumbia,specially

Results:ComparedwithpatientsintheUC group,theresultsofthoseintheECgroup wereasfollows:symptomscoresdecreasedby 50%;peakflowreadingsincreasedby11%; daysoffworkorschoolwerereducedby approximately0.6days/month;useofinhaled betaagonistswasreducedby50%;overall qualityoflifeimprovedby19%,andthe specificdomainsofactivitylimitations, symptomsandemotionalfunctionalso improved;initialknowledgescoresdoubled;

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CITATION; OUTCOMEVARIABLES (PEERREVIEWED) Columbia.CanRespirJ trainedandcertifiedinasthmacare, 2003;10(4):195202. agreedtoparticipateinastudyinwhich experiencedpharmacistswouldhave (YES) asthmapatientsallocatedtoenhanced (pharmaceutical)care(EC)orusualcare (UC).Pharmacistslessexperiencedwere clusteredbygeographyandhadtheir pharmaciesrandomizedtotwolevelsof care;eachpharmacythenhadpatients randomizedtoECversuscontrol,UCversus controlorECversusUCdependingontheir pharmacyrandomization.631patients providedconsent,ofwhich225inECorUC wereanalyzedforalloutcomes.Patients werefollowedforoneyear.
SimpsonSH,Johnson JA,TsuyukiRT. Economicimpactof communitypharmacist interventionin cholesterolrisk management:an evaluationofthestudy ofcardiovascularrisk interventionby pharmacists. Pharmacoth2001 May;21(5):62735.

RESULTS/CONCLUSIONS
emergencyroomvisitsdecreasedby75%;and medicalvisitsdecreasedby75%.Apatient satisfactionsurveyrevealedthepopulation wasextremelypleasedwiththeirpharmacy services.CostanalysisreinforcestheECmodel, whichismorecosteffectivethanUCinterms ofmostdirectandindirectcostsinasthma patients.Conclusion:Speciallytrained communitypharmacistsinCanada,usinga pharmaceuticalcarebasedprotocol,can produceimpressiveimprovementsinclinical, economicandhumanisticoutcomemeasures inasthmapatients.Thehealthcaresystem needstoproduceincentivesforsuchcare.

TheStudyofCardiovascularRisk InterventionbyPharmacists,a randomized,controlledtrialinover50 communitypharmaciesinAlbertaand Saskatchewan,Canada,demonstrateda pharmacistinterventionprogramimproved cholesterolriskmanagementinpatientsat highriskforcardiovasculardisease.Ina substudy,costsandconsequenceswere analyzedtodescribetheeconomicimpact oftheprogram.Twoperspectiveswere taken:agovernmentfundedhealthcare systemandapharmacymanager.Costs werereportedin1999Canadiandollars.

Incrementalcoststoagovernmentpayerand communitypharmacymanagerwere $6.40/patientand$21.76/patient, respectively,duringthe4monthfollowup period.Thecommunitypharmacymanager hadaninitialinvestmentof$683.50.The changeinFraminghamriskfunctionforthe interventiongroupfrombaselinealsowas reported.The10yearriskofcardiovascular diseasedecreasedfrom17.3%to16.4%(p< 0.0001)duringthefourmonths.The interventionprograminthisstudyledtoa significantreductionincardiovascularriskin theinterventiongroupduringthe4month followupperiod.Theincrementalcostto providetheprogramappearedminimalfrom bothgovernmentandpharmacymanager perspectives.Itishopedthattheseresults couldsupportnegotiationsforreimbursement ofclinicalpharmacyserviceswithpayers.

Sturgess,IK,McElnay JC,etal.Community pharmacybased provisionof pharmaceuticalcareto olderpatients.Pharm

Methods:Arandomized,controlled, longitudinal,clinicaltrialwithrepeated measureswasperformedoveran18 monthperiod,involvingcommunity pharmacies(fiveinterventionsandfive controls)inNorthernIreland.Elderly,

Results:Asignificantlyhigherproportionof interventionpatientswerecompliantatthe endofthe18monthstudyandexperienced fewerproblemswithmedicationcomparedto controlpatients(P<0.05).Therewaslittle impactonqualityoflifeandhealthcare

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OUTCOMEVARIABLES
ambulatorypatients(>or=65years), takingfourormoreprescribedmedications wereeligibleforparticipation.Patients attendinganinterventionpharmacy receivededucationonmedicalconditions, implementationofcompliancestrategies, rationalizingofdrugregimensand appropriatemonitoring;patientsattending controlsitesreceivednormalservices.A batteryofclinical,humanisticand economicoutcomeswasassessed. CostReduction

RESULTS/CONCLUSIONS
utilization.Conclusions:Pharmaceuticalcare provisiontocommunitydwellingpatients resultedinanimprovementinmedication complianceandevidenceofcostsavings. Futurepharmaceuticalcarestudiesmay benefitfromamorefocusedselective approachtodatacollectionandoutcomes measurement.

BootmanJL,Harrison DL,etal.Thehealth carecostofdrug relatedmorbidityand mortalityinnursing facilities.ArchIntern Med 1997;157(18):208996. (YES)

Objective:toassesstheimpactof pharmacistconducted,federally mandated,monthly,retrospectivereview ofnursingfacilityresidents'drugregimens inreducingthecostofdrugrelated morbidityandmortality.Methods:Using decisionanalysistechniques,aprobability pathwaymodelwasdevelopedtoestimate thecostofdrugrelatedproblemswithin nursingfacilities.Anexpertpanel consistingofconsultantpharmacistsand physicianswithpracticeexperiencein nursingfacilitiesandgeriatriccarewas surveyedtodetermineconditional probabilitiesoftherapeuticoutcomes attributabletodrugtherapy.Healthcare utilizationandassociatedcostsderived fromnegativetherapeuticoutcomeswere estimated.

Results:Baselineestimatesindicatethecostof drugrelatedmorbidityandmortalitywiththe servicesofconsultantpharmacistswas$4 billioncomparedwith$7.6billionwithoutthe servicesofconsultantpharmacists. ConclusionsWiththecurrentfederally mandateddrugregimenreview,itisestimated thatconsultantpharmacistshelptoreduce healthcareresourcesattributedtodrug relatedproblemsinnursingfacilitiesby$3.6 billion.

BrooksJM, McDonoughRP, DoucetteW. Pharmacist reimbursementfor pharmaceuticalcare services:Whyinsurers mayflinch.Drug BenefitTrendsJune 2000;4562. (YES)

Researchersdevelopedcomplexeconomic Researchersconcludedthatenrollinghighrisk modeltoevaluatewhetherpharmaceutical patientsintopharmaceuticalcareprograms careiscosteffective. canbeofvaluetoinsurersifthesavings incurredismorethantheprogramexpense. Basedonthemodel,authorsconcludethat reimbursingpharmaciststoprovide pharmaceuticalcareisoptimalifarelatively inexpensivepatientscreeningmethodis availablethatenablesinsurerstolimitvisitsto thosepatientswhooffercostsavingstothe insurer.

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RESULTS/CONCLUSIONS

ChristensenDB,Neil N,etal.Frequencyand characteristicsof cognitiveservices providedinresponse toafinancial incentive.JAmPharm Assoc2000;40(5):609 17. (YES)

Todeterminetheeffectsofafinancial incentiveonthenumberandtypesof cognitiveservices(CS)providedby communitypharmaciestoMedicaid recipientsintheStateofWashington.CS werereportedusingaproblem interventionresultcodingsystemovera 20monthperiod.

Results:Studypharmacistsdocumentedan averageof1.59CSinterventionsper100 prescriptionsovera20monthperiod, significantlymorethancontrols,who documentedanaverageof0.67interventions (P<0.05)per100prescriptions.Onehalf (48.4%)ofallCSwereforpatientrelated problems,32.6%werefordrugrelated problems,17.6%wereforprescriptionrelated problems,and1.4%wereforotherproblems thatdidnotinvolvedrugtherapy.Achangein drugtherapyoccurredasaresultof28%ofall CSdocumentedinthisdemonstration. Changeswererarely(2.4%)duetogenericor therapeuticsubstitutionandalmostalways (90%)followedcommunicationwiththe prescriber.Theaverageselfreportedtimeto performCSwas7.5minutes;75%of interventionswere<or=6minutes. Considerabledifferencesexistedbetween studyandcontrolgroupsinthetypesof problemsidentified,interventionactivities performed,andresultsofinterventions. Conclusion:Afinancialincentivewas associatedwithsignificantlymore,and differenttypesof,CSperformedby pharmacists.

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Thegoalsofthisstudyweretodetermine: (1)thefrequencywithwhich recommendationsweremadeby pharmacistsinresponsetotargetedprofile alertsaimedathighriskpatients,(2)the frequencyandtypeofdrugtherapy changes,and(3)theimpactondrug relatedqualityandcosts.Objectivewasto reducepolypharmacyinMedicaid recipients.

RESULTS/CONCLUSIONS
Prescriptionprofilesweregeneratedfrom Medicaidclaimsdataandsenttoconsultant pharmacistsfor9,208patientsin253nursing homes.Pharmacistsreturned7548(82%)ofall profilessenttothem.Afterexcluding1,204 patients(13%)whoweredischargedor deceased,6,344patients(69%)remainedfor analysis.Baselinemeanwas9.52prescriptions permonth,withmeandrugcostof$502.96to NorthCarolinaMedicaidprogram.Pharmacists offeredameanof1.58recommendationsto prescribers.Afterphysicianconsultation,>or= 1recommendationwasimplementedfor72% ofpatientswithachangerecommendation, 68%ofwhomexperiencedaswitchtoalower costdrug.Afterintervention,meanreduction indrugcostwas$30.33perpatientpermonth. Costsavingsfromonemonthalonecovered thecompensationpaidtopharmacistsfor consultationefforts.Conclusion:This supplementalprogramofmedicationreviews fortargetednursinghomepatientsresultedin areductionofpolypharmacyandwas beneficialbasedsolelyondrugcostsavings.

ChristensenD, TrygstadT,etal.A pharmacy management interventionfor optimizingdrug therapyfornursing homepatients.AmJ GeriatrPharmacother 2004;2(4):24856. (YES)

McMullin,ST, HennenfentJA,etal.A prospective, randomizedtrialto assessthecostimpact ofpharmacistinitiated interventions.Arch InternMed 1999;159(19):23069. (YES)

Objective:Toassesstheimpactof pharmacistinitiatedinterventionsoncost savings.Methods:Sixpharmacistsata largeuniversityhospitalrecordedpatient specificrecommendationsfor30days.All qualityofcareinterventionswere completedbythepharmacists,butthose strictlyaimedatreducingcostswere stratifiedbydrugclassandrandomizedto aninterventionorcontrolgroup. Pharmacistscontactedphysicianswith costsavingrecommendationsinthe interventiongroup,whilecontrolgroup patientsweresimplyobserved.Outcome measure:Drugcostsafterrandomization.

Results:Most(79%)ofthe1,226interventions recordedwereaimedatimprovingqualityof care.Theremaining21%providedequivalent qualityofcare,butatlessexpense.Thesecost savinginterventionstypicallyinvolved streamliningtherapytolessexpensiveagents, discontinuinganunnecessarymedication,or modifyingtherouteofadministration.The grouprandomizedtoreceiveapharmacist's interventionhaddrugcoststhatwere41% lowerthanthoseinthecontrolgroup(mean, $73.75vs.$43.40;P<0.001).Interventions involvingantiinfectiveagentshadthegreatest costsavings(mean,$104.08vs.$58.45;P< 0.001).Fortheinstitution,thisextrapolatesto anannualsavingsofapproximately$394,000 (95%confidenceinterval,$46,000$742,000). Asexpected,theseinterventionshadno

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RESULTS/CONCLUSIONS
impactonlengthofhospitalstay,inhospital mortality,30dayreadmissions,ortheneedto readministerthetargetedmedicationor restartIVtherapy.Conclusion:While interventionssolelyaimedatreducingcosts representasmallportionofapharmacist's activities,theycanresultinsignificantsavings foraninstitution.

SchumockGT,Meek PD,PloetzPA. Economicevaluations ofclinicalpharmacy services19881995. ThePublications Committeeofthe AmericanCollegeof ClinicalPharmacy. Pharmacotherapy 1996Nov Dec;16(6):1188208.

Literaturereviewof104articlesidentified aseconomicassessmentsofclinical pharmacyservices.Thearticlesfellinto fourmaincategories:diseasestate management(4%),general pharmacotherapeuticmonitoring(36%), pharmacokineticmonitoringservices (13%),andtargeteddrugprograms(47%).

Themajority(89%)ofthestudiesreviewed describedpositivefinancialbenefitsforthe varietyofclinicalpharmacyservicesevaluated, andstudiesthatwerewellconductedwere mostlikelytodemonstratepositiveresults.

WalkerS,WilleyCW. Impactondrugcosts andutilizationofa clinicalpharmacistina multisiteprimarycare medicalgroup.J ManagCarePharm 2004;10(4):34554. (YES)

Objectives:Tomeasurethecostand utilizationoutcomesofapharmacist interventioninaprimarycaremedical groupoperatingunderafinancialrisk contractwithahealthplan.Methods:A prestudypoststudydesignusingnational drugutilizationforthecomparisonwas employedtoassesstheimpactof physicianprescribereducationusing informationderivedfromprescriber specificdrugcostandutilizationanalyses. Drugcostsweremeasuredasnetmedical groupcostsperenrolledmemberperyear (PMPY),theproductoftheaveragecost perprescription,andthenumberof prescriptionsPMPY,overtwoyearperiod.

Drugcostsperpatientperyearincreased1.7% versusnationalincreaseof31.2%. Prescriptionsperpatientperyearincreased 4%versusunchangednationalrate.Costper prescriptiondecreased2.1%versusnational increaseof31.2%.Resultsduetoincreasein useofgenerics.Conclusion:Atargeted educationalprogramforphysicianprescribers conductedbyaclinicalpharmacistworkingfor aprimarycaremedicalgroupcanreducethe expendituresforoutpatientdrugtherapyby loweringtheaveragecostperpharmacyclaim.

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Aprimarycarepharmacypracticemodel wasestablishedatagovernmenthealth carefacilityinMarch1996.Theoriginal objectivewastoestablishaprimary pharmacypracticemodelthatwould demonstrateimprovedpatientoutcomes andmaximizethepharmacist's contributionstodrugtherapy.

RESULTS/CONCLUSIONS
Manyoutcomesstudieshavebeenperformed onthepharmacistinitiatedandmanaged clinics,leadingtoimprovedpatientcareand conveyingthequalityconsciousandcost effectiverolepharmacistscanplayas independentpractitionersinthisenvironment. Asystemusingpharmacistsasindependent practitionerstopromoteprimarycarehas achievedhighqualityandcosteffective patientcare.

CarmichaelJM, AlvarezA,ChaputR, DiMaggioJ,Magallon H,MambourgS. (2004).Establishment andoutcomesofa modelprimarycare pharmacyservice system.AmJHealth SystPharm2004Mar 1;61(5):47282. (YES)

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AppendixC:U.S.CollaborativePracticeMap

AppendixCdisplaysamapoftheUnitedStates.Colorblockedstatesdepictwhereregulatory authorityforpharmacistsandphysicianstocollaborateexist.AsofMay2011,44stateshave specificregulatoryauthorityforpharmacistphysiciancollaboration,sixstatesdonot(AL,DE,IL, KS,OK,SCandDC),andoneispendinglegislation(Missouri).Maineiscolorblockedbuthas limitedapplication,(emergencycontraceptiononly). Theauthorsusedthe2011SurveyofPharmacyLawavailablefromtheNationalAssociationof BoardsofPharmacyasasourceforthismap.UnderSection28MiscellaneousStatePharmacy Laws,theanswertoMayPharmacistsInitiate,Modify,and/orDiscontinueDrugTherapy PursuanttoaCollaborativePracticeAgreementorProtocol?wasutilizedindetermining CollaborativePracticestatus.

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AppendixD:PhysicianSurvey Objective:TheIndianHealthService(IHS)NationalClinicalPharmacySpecialist(NCPS)Program soughttoobtaininformationfromIHSphysiciansontheirattitudesandperceptions1)toward pharmaciststhatdeliverpatientcareservices,and2)ontheeffectivenessofthismodelof healthcaredelivery(intermsofpatientoutcomeandhealthcaresystemimprovement).The goalofthesurveywastocollectdataregardingphysiciansperceptionsintermsof effectivenessandimpactofhealthcaredeliveryworkingwithNCPSpharmacists.Thisisthefirst physicianonlysurveycompletedregardingIHSclinicalpharmacyspecialistsdistributedIHS wideandprovidesauniquelookatphysicianattitudeswithinamature(experienced) collaborativepracticesettingbetweenphysiciansandpharmacists. Methods:AninternetbasedsurveytoolwasdevelopedanddistributedbytheNCPSProgram tositesthathaveIHSphysicianswhoworkwithNCPSpharmacistspracticingthrough collaborativepracticeagreements(CPAs).Thesurveywasdistributedtoapproximately356IHS physiciansfromIHS(n=20)andTribal(n=13)facilities,spanning13statesacrossnineofthe12 IHSgeographicAreas.Therespondentdrivensamplingsurveywasdisseminatedbyemail. Results:Atotalof118(33%)of356physiciansresponded.Physiciandemographicsincluded diversepracticeenvironmentssuchasreferralmedicalcenters,smallhospitalsandambulatory healthclinics.PhysiciansreportedCPAswereutilizedtoworkwithNCPSpharmacists.The majorityofdiseasestatesmanagedbypharmacistsincludedanticoagulation,dyslipidemiaand tobaccocessation.However,manyotherconditionssuchasheartfailure,painmanagement, asthma,chronickidneydisease,diabetes,infectiousdisease(HIV,tuberculosis,etc.)andalcohol abstinenceclinicswerealsoreported.Pharmacistdeliveredpatientcareservicesincluded(but werenotlimited)toprescriptive,laboratoryandassessmentprivileges.ManyCPAsalsoinclude carecoordination,patientfollowupanddiseaseprevention/healthpromotionservices. Overall,respondentphysiciansreportedseeingpositivepatientandhealthsystemoutcomes fromthesepatientcareservices(96%).Morespecifically,respondentsindicatedthat collaborativepracticewithpharmacistsintheirfacilitieshelpedthemtoimproveoverall primarycare(88%).Additionally,theyreportedreductionsincomplicationsoftherapy(77%). Respondentsreportedthatpharmacistbasedprimarycareclinicsincreasepatientaccessto careandimproveddiseaseoutcomes(75%).Adecreasedphysicianworkloadwasnotedby physicians(82%),whichallowedthemtoshiftthefocusofcaretomorecriticallyillpatients. Physiciansagreedthatthesepharmacistshaveadequateknowledgeandtrainingtoprovide clinicalservicestopatients(85%)andthattheseservicesarenecessarytooptimizepatientcare (72%).RespondentsfeltthatthescopeofdiseasesmanagedbyNCPSpharmacistswas adequate(80%),whilesomeevenreportedthescopewastoonarrow(11%). Physiciansalsoagreedorstronglyagreedthatservicesprovidedbypharmacistsprovide adequateevidencetorecognizethemasbillablenonphysicianpractitioners(76%).Several physicianscommentedthatbecauseofthesepharmacistdeliveredpatientcareservices,they areabletoexpandtheabilitytoprovideprimarycareinunderservedsettings.Othercomments included: 80


IntheIHS,Idependonpharmaciststoaidinprovidingthebestqualityofcareformy patients. PharmacybasedhealthcareprovidershavebeenanintegralpartoftheIHSduringmy tenurewiththeagencyandhavealmostuniformlyimproved/elevatedhealthstatusfor NativeAmericans.TheseservicesshouldberecognizedbyCMS. Inanextremelyunderservedsetting,ourclinicalpharmacistsprovideexcellentcareto patientswhowouldotherwisereceivenocareatallorlessfrequentandtherefore lowerqualitycare. Clinicalpharmacistshavegreatlyexpandedtheabilityofourdepartmenttoprovide careinaveryunderservedsetting. Ourdepartment[FamilyMedicine]feelsthatwecouldimprovepatient care/access/education/compliancebyhavingmorepharmacistcliniciansinourclinics. Conclusion:AnoverwhelmingmajorityofIHSphysicianrespondents,whoworkwithNCPS pharmacistsdeliveringprimarycareservices,believethiscollaborativeapproachimproves healthoutcomes,healthcaredelivery,andaccesstocare.Tosustainandscaleupthesevalued servicestothepatientandhealthcaresystem,moreformalrecognitionashealthcare providersandappropriatecompensationmechanismsareessential. [Thesurveytoolisdisplayedasfourpages;originalformatiselectronic.Thesurveyconsistsof Section1PurposeofSurveyandNCPSProgramBackground,Section2NCPSProviderSurvey (12questions),Section3Demographics,andSection4Feedback.]

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