Access to Essential Medicines in Kenya

Ministry of Ministry of Public Health

Medical Services and Sanitation

Republic of Kenya

Access to Essential Medicines in Kenya

A Health Facility Survey

AccesstoEssentialMedicinesinKenya AHealthFacilitySurvey PublishedbytheMinistryofMedicalServicesandMinistryofPublicHealth&Sanitation www.health.go.ke December2009 Anypartofthisdocumentmaybefreelyreviewed,quoted,reproduced,ortranslatedinfullorinpart, providedthatthesourceisacknowledged. Itmaynotbesold,orusedinconjunctionwithcommercialpurposesorforprofit. ThisdocumentwasproducedwiththesupportoftheWorldHealthOrganization(WHO)KenyaCountry Office,andallreasonableprecautionshavebeentakentoverifytheinformationcontainedherein. Thepublishedmaterialdoesnotimplytheexpression ofanyopinionwhatsoeveronthepartofthe WorldHealthOrganization,andisbeingdistributedwithoutanywarrantyofanykind–either expressedorimplied.Theresponsibilityforinterpretation anduseofthemateriallieswiththereader. InnoeventshalltheWorldHealthOrganization beliablefordamagesarisingfromitsuse. Usersofthispublicationareencouragedtosendanycommentsandqueriestothefollowing addressfromwhichadditionalcopiesmaybeobtained: TheChiefPharmacist MinistryofMedicalServices AfyaHouse,POBox30016ͲGPO,Nairobi00100 Email:[email protected] TableofContents

LISTOFTABLES...... III LISTOFFIGURES...... III ABBREVIATIONSANDACRONYMS...... IV FOREWORD...... V ACKNOWLEDGEMENTS...... VI EXECUTIVESUMMARY...... 1 1.INTRODUCTION...... 5

1.1BACKGROUND...... 5 1.2IMPLEMENTATIONOFTHESURVEY...... 7 1.3OBJECTIVES...... 7 2.COUNTRYBACKGROUND...... 8

2.1HEALTHSECTOR...... 9

2.1.1Healthstatusandindicators...... 9 2.1.2Healthpolicyandstrategicplanning...... 10 2.1.3Healthsystemstructure,statusandchallenges...... 10 2.1.4Healthpartnershipandcoordination...... 11

2.2PHARMACEUTICALSECTOR...... 11

2.2.1NationalPharmaceuticalPolicy...... 12 2.2.2Regulatorysystem...... 12 2.2.3Medicinessupplysystem...... 13 2.2.4Medicinesfinancing...... 14 2.2.5Rationaluseofmedicines...... 15 3.STUDYDESIGNANDMETHODS...... 16

3.1SAMPLING...... 16

3.1.1Sectorssurveyed...... 16 3.1.2Samplingofregions(provinces)...... 16 3.1.3Samplingofdistricts...... 16 3.1.4Samplingoffacilities...... 17 3.1.4Selectionofpatients...... 17 3.1.5Selectionofprescriptions...... 17 3.1.6Selectionofmedicinestosurvey...... 17

3.2DATACOLLECTION...... 17

3.2.1Organizationofdatacollection...... 17 3.2.2Adaptationoftools...... 18 3.2.3Selectionandtrainingofdatacollectors...... 18 3.2.4DataCollection...... 18

3.3DATAENTRYANDANALYSIS...... 18 3.4MONITORINGOFMEDICINEPRICESANDAVAILABILITY(MMEPA)...... 19 3.5LIMITATIONSOFTHEDATA...... 19 4.RESULTSANDDISCUSSION...... 20

4.1DEFINITIONOFTERMSANDCONCEPTS...... 20

i 4.2AVAILABILITY...... 21 4.3PRICINGANDAFFORDABILITY...... 26 4.4GEOGRAPHICALACCESSIBILITY...... 32 4.5MEDICINESQUALITYͲRELATEDFACTORS...... 33 4.6RATIONALUSEOFMEDICINES...... 35 4.7HEALTHPROFESSIONALSPROFILES...... 42 5.SUMMARYOFRESULTS...... 46 6.DISCUSSION...... 48 7.CONCLUSIONS...... 51 8.RECOMMENDATIONS...... 52 ANNEXES...... 54

ANNEX1:SUMMARYLISTOFINDICATORSANDCORRESPONDINGSURVEYFORMSUSEDFORDATACOLLECTION...... 56 ANNEX2:LEVELIISURVEYFORMS...... 57 ANNEX3:CHARACTERISTICSOFOUTPATIENTSINTERVIEWED...... 72 ANNEX4:LISTOFDATACOLLECTORS...... 73 ANNEX5:LISTOFSAMPLEDHEALTHFACILITIES...... 74 ANNEX6:BASIC(CORE)MEDICINESLIST(COUNTRYLIST)...... 77 ANNEX7:MMEPAMEDICINESLIST...... 77 REFERENCES...... 78 GLOSSARY...... 79

ii LISTOFTABLES

Table1:KenyaEconomic&HealthIndicators...... 9 Table2:KeyPharmaceuticalSubͲsectorIndicators...... 11 Table3:ListofSampledDistricts...... 16 Table4:SummaryofAvailabilityIndicatorsfor15BasicMedicines...... 21 Table5:Medianavailabilityofmedicines(MMePAlist)...... 22 Table6:Percentageofprescribedmedicinesactuallydispensed...... 23 Table7:MedicinesstockͲoutdurationinhealthfacilities...... 24 Table8:AdequacyofStockRecords...... 25 Table9:MedianProcurementPriceRatios(comparedwithIRPs)...... 26 Table10:Freeofchargemedicines:public,FBHSandprivatefacilities...... 27 Table11:Patientprices:ratioofmedianpricestoIRP:public,FBHS&privatesectors...... 27 Table12:Medianpatienttoprocurementpriceratios...... 28 Table13:MedianMPRsfor14medicinesfoundinpublic,FBHSandprivatesectors...... 28 Table14:AverageOutͲPatientMedicinesCosts...... 29 Table15:Affordabilityofselectedstandardtreatments...... 31 Table16:GeographicalAccessͲTransportCosts...... 32 Table17:PercentofExpiredMedicines...... 33 Table18:GeneralIndicatorsforRationalUseofMedicines(bysector)...... 35 Table19:Adherenceofprescriberstorecommendedtreatmentguidelines...... 39 Table20:DispensingIndicators...... 40 Table21:Dispenserprofileandcompliancewiththelaw...... 43 Table22:PrescriberProfile...... 44 LISTOFFIGURES

Figure1:Coreindicatorsusedtomonitorandassess...... 6 Figure2:MapofKenya...... 8 Figure3:HealthSectorPyramid...... 10 Figure4:MedianAvailabilityofEssentialMedicines(countrylist)...... 22 Figure5:Rangeofthe%ofprescribedmedicinesactuallydispensedoradministered...... 23 Figure6:AveragestockͲoutdurationofmedicinesinhealthfacilities(rangeofdays)...... 25 Figure7:Affordabilityofadultandchildpneumoniatreatment(indays’wages)...... 30 Figure8:Affordabilityoftreatments:Adultdiabetes,childasthma...... 30 Figure9:Percentageofpatientstaking>1hourtotraveltoadispensingfacility...... 32 Figure10:Adequacyofmedicinesstorageconditions...... 34 Figure11:Prescribingofantibiotics,injections,medicinesontheEMLandbyINN...... 35 Figure12:Adequacyoflabelingandpatientknowledge...... 40 Figure13:Percentageofprescriptionmedicinesboughtwithoutaprescription...... 42 Figure14:DispenserProfileandFacilitiesCompliancewithNationalLaws...... 44 Figure15:PrescriberProfile...... 45

iii ABBREVIATIONSANDACRONYMS

AL Artemether/lumefantrine ARI AcuteRespiratoryInfection EML EssentialMedicinesList DH DistrictHospital Disp Dispensary FBHS FaithͲBasedHealthServices FBO FaithͲBasedOrganisations GDP GrossDomesticProduct HAI HealthActionInternational HC HealthCentre HDI HumanDevelopmentIndex HFS HealthServicesSurvey HH Household Ind Indicator Inj Injection IRP InternationalReferencePrice KEPH KenyaEssentialPackageforHealth KES KenyaShillings KMPDB KenyaMedicalPractitionersandDentistsBoard ML WHOModelListofEssentialMedicines MMePA MonitoringofMedicinePricesandAvailability MOMS MinistryofMedicalServices MSH ManagementSciencesforHealth NHIF NationalHealthInsuranceFund NMP NationalMedicinesPolicy PGH ProvincialGeneralHospital PSA PharmaceuticalSituationAssessment RUM RationalUseofMedicines SD StandardDeviation SDH SubͲDistrictHospital STG StandardTreatmentGuidelines USD UnitedStatesdollars(also$) WHO WorldHealthOrganization %ile Percentile

iv FOREWORD

The stated goal of the revised Kenya National Pharmaceutical Policy (KNPP) is Universal Accesstoqualitypharmaceuticalservices,EssentialMedicines,essentialhealthtechnologies in Kenya. This national goal resonates with MDG8 Target E: in collaboration with the pharmaceutical industry, ensure access to affordable essential medicines in a sustainable manner. TheattainmentofthisMDGtargetwouldalsocontributetotheattainmentofMDG 4,5and6,i.e.improvingchildhealth,maternalhealth,aswellascontrolofHIV/AIDS,TB, Malariaandotherdiseases.AccessencompassestheavailabilityofEssentialMedicines,their affordability,storage,recordͲkeeping,prescribing,dispensingandthepersonnelconcerned– allwithreferencetonationallaws,establishednormsandstandards.

BecausethepharmaceuticalsectoriscomplexandmultiͲfaceted,severalcrossͲcuttingfactors influence access to Essential Medicines. Therefore, regular monitoring and evaluation is criticalindeterminingtheextenttowhichexistingpolicies,strategiesandinterventionsare impacting on access. Pharmaceutical services in Kenya are provided in the context of the KNPP, the National Health Sector Strategic Plan (NHSSP II) and the strategic plans of the Ministries of Medical Services and Public Health and Sanitation. Pharmaceutical situation assessmentsarethusacoreelementofhealthsectorM&E;andakeysourceofevidencefor policydevelopmentandstrategicplanning.

ThishealthfacilitysurveyisatimelyadditiontothebodyofevidenceonthegoalofNHSSPII: reversing the declining trends in key health sector indicators. The findings and recommendationsprovidevaluableinsightsintothestatusofaccesstoEssentialMedicinesin Kenya,andthefactorspositivelyoradverselyinfluencingaccess.Theinformationisexpected to facilitate evidenceͲbased planning, thus contributing to better integration of pharmaceuticals within the health sector strategic and coordinating frameworks. Consequently, the evidence will be used as a platform for developing a Pharmaceutical Strategy to guide coordinated investment and resource allocation towards achieving universalaccesstoEssentialMedicinesinKenya.

Thisassessmentwasgreatlyfacilitatedbytheexistenceofacomprehensivepackageoftools developed by WHO, which were subsequently adapted to the health sector in Kenya. It is expectedthatstandardizedpharmaceuticalsituationassessmentswillbeintegratedintothe health sector M&E framework, in order to inform evidenceͲbased investment (financial, infrastructureandhumanresources)thatisalignedtowardsimpactingoutcomesacrossthe entirespectrumofpharmaceuticalserviceswithintheKEPH.

Westronglyencourageallhealthstakeholderstomakethebestuseofthisreportintheir health planning and monitoring activities. The information will be particularly useful to Governmentinstitutionsanddepartments,healthdevelopmentandimplementingpartners, training and research institutions as well as other national and international stakeholders. Wealsowelcomefeedbackandanysuggestionstowardsimprovementoffutureassessments.

DrFrancisMKimaniDrSSharifMBS,MBchB,MMedDLSHPM,MSc DirectorofMedicalServices DirectorofPublicHealth&Sanitation

v ACKNOWLEDGEMENTS

The2008PharmaceuticalSituationAssessmentwasconductedbytheMinistriesofMedical Services and Public Health and Sanitation, facilitated through the office of the Chief Pharmacist. This was the second such assessment after the baseline survey of 2003. The exercise culminated in the production of two reports on Access to Essential Medicines in Kenya – this health facility survey, and a separate household survey. The study would not have been possible without the cooperation of the Provincial Medical Officers in all six provinces where the study was carried out. The Ministries also appreciate the support, cooperationandinformationprovidedbythepublichealthfacilities,theFaithͲBasedHealth Services (FBHS) and the private pharmacies surveyed. Special thanks go to all the departments/sectionsoftheMinistries,thehealthpersonnelandthepatientswhowillingly providedtheinformationanalyzedinthisreport. Special gratitude is extended to all those who participated in the data collectionand data entry(seeAnnex4)andtothefollowingmembersoftheAdvisoryGroup,fortheirinvaluable inputsintothestudydesign,samplingandanalysis: FredSiyoi DeputyChiefPharmacist/DeputyRegistrar,MOMS AhmedMohammed DeputyRegistrar,PharmacyandPoisonsBoard NjeriMucheru DeputyChiefPharmacist,DivisionofPharmaceuticalPolicy,MOMS ChristaCepuch ProgrammeDirector,HealthActionInternational(HAIͲAfrica) JoanWakori RegionalLiaisonOfficer,KenyaMedicalSuppliesAgency(KEMSA) JenniferOrwa Chairperson,INRUD/Kenya JaneMasiga HeadofOperations,MissionforEssentialDrugsandSupplies(MEDS) ReginaMbindyo NationalMedicinesAdviser,WorldHealthOrganizationͲKenya MartinAuton Consultant,HAIͲAfrica This facility survey was conducted with financial supportͲ through the World Health Organization(WHO)ͲfromtheUKDepartmentforInternationalDevelopment(DFID)project onAccesstoEssentialMedicines;andtheEuropeanCommission’sEC/ACP/WHOPartnership onPharmaceuticalPolicies.TheWorldHealthOrganizationprovidedtechnicalsupportforthe survey in collaboration with HAIͲAfrica, in the context of the DFIDͲsupported WHO/HAI Collaboration project on Access to Essential Medicines. This assistance is gratefully acknowledged. Special gratitude is extended to Njeri Mucheru (MOMS), Joan Wakori (KEMSA), Christa Cepuch(HAIͲAfrica)andReginaMbindyo(WHO),fortheirtirelesseffortsinthedataanalysis and compilation of the report; and to Chris Forshaw who assisted with report editing and formatting. DRKIPKERICHKOSKEI ChiefPharmacist/Registrar,MinistryofMedicalServices

vi EXECUTIVESUMMARY

BACKGROUND ThissurveyonAccesstoEssentialMedicinesinKenyawasundertakenaspartoftheWHO LevelIIPharmaceuticalSituationAssessment(PSA)forKenya.Thisisastandardizedsurvey thataimstoprovidesystematicdataonaccesstoessentialmedicines,fromtheperspectives ofthehealthcaresystem(HealthFacilitySurvey)and ofhouseholds(HouseholdSurvey).A household survey was undertaken concurrently and is published as a separate report. Together,thesereportscomprisethesecondPharmaceuticalSituationAssessmentinKenya, providing updated data from an earlier baseline survey undertaken in 2003. This report documents theHealthFacilitySurveyundertakenin 2008,and comparesthefindingswith the2003baseline. METHODS ThesurveyinstrumentsarebasedonstandardizedmethodologiesforLevelIIPSAdeveloped bytheWorldHealthOrganization(WHO);andthestandardmethodologiesformedicineprice measurement and monitoring, developed jointly by WHO and Health Action International (HAI).Thesurveywasconductedinhealthfacilitiesinsixoftheeightprovinces:Nairobi,Rift Valley,Western,Nyanza,CoastandNorthEastern;andamongthethreehealthcareprovider sectors (public, FBHS and private). In each region, six health facilities per sector were surveyed,totaling108sites(i.e.36governmenthealthfacilities,36privatepharmaciesand 36FBHShealthfacilities).DatawasalsocollectedfromKEMSAandMEDS,thetwocentral warehouses supplying the public and FBHS facilities respectively. Data was collected using standardizedsurveyformsadaptedtothecountrysituationandadditionaldatawasobtained fromongoingMonitoringofMedicinePricesandAvailability(MMePA).Thisentailsvisitsby data collectors to total of 96 sites comprising public and FBHS facilities and private pharmaciesinfourprovinces(Coast,Eastern,NairobiandRiftValley)everythreemonths,to documentpricesandavailabilityof36medicinesusingastandardizeddatacollectionform. DatawasanalyzedusingMicrosoftExcel®,andtheWHOͲHAIworkbookwasusedtoanalyze medicinepriceandavailabilitydata.

KEYFINDINGS The survey findings are reported as standard indicators, defined in detail in the WHO and WHO/HAIstandardmethodologies.

AvailabilityofEssentialMedicines a) Themajorityofbasicmedicinestotreatcommonconditionsatprimarycarelevelwere availableinallsectorsduringthissurveyperiod.However,abroaderscopeofessential medicineswaslessavailableinfacilitiesacrossallsectors. b) PublicandFBHSfacilitiesexperiencestockͲoutsofbasicessentialmedicinesforabout46 and14daysperyearrespectively.Thepublicsectorsupplychainisespeciallyproneto significant interruptions and critical stock outs, extending beyond 30 or even 90 consecutivedays. c) KEMSA and MEDS have high availability and virtually no stockͲouts of basic essential medicinesandtheymaintainadequatemedicinestockrecords. d) Theproportionofprescribedmedicinesthatwereactuallydispensedtopatientswas98% inFBHSfacilitiescomparedwith86%inpublicfacilities.Therefore,patientsweremore likelytoobtainallprescribedmedicinesfromtheFBHSfacilities.

1 MedicinePricesandAffordability a) ProcurementbyKEMSAandMEDSisalmostexclusivelyforgenericproducts,andthey obtainpriceͲefficiencywellbelowIRPs.WithanMPRof0.44,KEMSAobtains comparativelylowerprocurementpricesthanMEDSwithanMPRof0.61. b) Patientsobtainingmedicinesfromthepublicsectorfacecomparativelylowerorno financial barriers. Most(89%)surveyedmedicineswereissuedforfreeinthepublic sector,comparedwith15%inFBHSfacilitiesandnoneintheprivatepharmacies. c) Patientprices(wherecharged)inthepublicsectorwereabout40%lowerthanthosein theFBHSfacilities,andabout50%lowerthanthoseintheprivatesector. d) PriceschargedtopatientsforessentialmedicinesinthepublicandFBHSfacilities,areat leastfourtimeshigherthantherespectiveprocurementpricesatthecentrallevel. e) Fortheconditionsstudied,andwithreferencetotheminimumwage,individual treatmentswouldbefairlyaffordableinallsectorsandespeciallysointhepublicsector.

Quality a) Incidenceofexpiredmedicineswasonlyabout2%inallsectors;centrallyandinfacilities. b) Storageconditionsinpublicfacilitiesarecriticallyinadequate,puttingatriskthequalityof medicines distributed through this sector. Storage facilities were inadequate in 40% of thesefacilities,comparedwith25%and20%ofFBHSandprivatepharmaciesrespectively. c) The MEDS warehouse met all the criteria for medicines storage and conservation, comparedtoKEMSAwhichmetonly50%ofthecriteria. d) Storageconditionsinpublichealthfacilitieswerefoundtohavedeterioratedorremained inadequatebothcentrallyandinhealthfacilitiescomparedtothebaselineof2003. RationalUseofMedicines a) ThenationalSTGsandEMLͲkeytoolsforpromotingRUMͲwerenotavailabletomost healthcareworkersinallsectors.STGswereavailablein42%and25%ofpublicandFBHS facilitiesrespectively;andtheEMLin39%and47%ofthesefacilitiesrespectively. b) Adherenceofprescriberstostandardtreatmentguidelinesismixedandinconsistentin bothsectors.Whereasthereissomeconformancetorecommendedfirstlinetreatments, prescribingofantibioticswashigh,being77%and68%inthepublicandFBHSfacilities respectively,againstareferenceof30%. c) Prescribingbygenericnamewasextremelylow.Only32%and35%ofmedicineswere prescribedbygenericnameinthegovernmentandFBHSfacilitiesrespectively. d) Amedianof93.4%wasfoundformedicinesprescribedaccordingtothenationalEMLin thepublichealthfacilities,indicatingverygoodadherenceofprescriberstothislist. e) Labellingofdispensedmedicineswasinadequateinallsectorsandcriticallylowinpublic facilities. Only 5% of medicines at public health facilities were adequately labelled comparedwith21%and40%inFBHSfacilitiesandprivatepharmaciesrespectively. f) The majority of patients had fairly adequate knowledge of how to take the medicines dispensed.Adequacyofthisknowledgewaslower(77%)forpatientsobtainingmedicines from public facilities, compared with 87% for FBHS facilities and 93% for private pharmacies.

2 HealthProfessionalsProfiles a) FewpublicandFBHSfacilities(38%&31%respectively)compliedwiththelawconcerning dispensingbyqualifiedpersonnel,comparedwith81%ofllicensedprivatepharmacies. b) Untrainedstaffwasthemostfrequentdispenserinpublicfacilities(42%);nursesinFBHS facilities(47%)andpharmaceuticaltechnologistsinprivatepharmacies(61%). c) A clinical officer was the most common prescriber, being in 53% of public and 61% of FBHS facilities respectively; and the nurse was prescribing in 42% and 39% of these facilitiesrespectively d) Untrainedstaffwerefoundprescribingin14%ofpublicfacilitiesand6%ofFBHSfacilities. CONCLUSIONS 1. The majority of basic essential medicines to treat common conditions at primary care levelareavailableandfairlyaffordabletoKenyansthroughthepublic,FBHSandprivate sectors. But medicine stockͲouts are prevalent and sometimes critical and essential medicinesforabroaderscopeofhealthneedsarelessavailable. 2. CentralizedbulkprocurementofessentialmedicinesthroughKEMSAandMEDSispriceͲ efficientandgenerallymaintainsadequatestocksofbasicessentialmedicines. 3. Thepricebarrierthatpeoplemayfacewhenaccessingmedicinesissignificantlylessin thepublicsector.Patientsobtainthemajorityofbasicessentialmedicinesforfree,orpay the lowest prices comparatively. However, frequent stockͲouts are a major barrier to access,especiallyforthepoor. 4. The FBHS play a role in lowering the price barrier for medicines. Some medicines are issuedforfreeandpatientpricesaregenerallylowerthantheprivatesector. 5. The price efficiency of centralized bulk procurement is not sustained in the pricing of medicinesbythepublicandFBHSsupplysystems.Wheremedicinesarenotissuedfor free,patientspayaroundfourtimestheprocurementpricesinbothsectors. 6. The storage infrastructure for medicines in the public sector is critically inadequate throughout the supply chain, putting at risk the quality of medicines provided through thissector.StorageinfrastructureinFBHSfacilitiesisalsoinadequate. 7. ThereismixedperformanceonRUMacrossallsectors,withsomeadherencetoSTGsbut highprescribingofantibioticsandlowprescribingbygenericname.Thismayresultfrom a lack of policy guidance or strategic approach to guide health sector investment in promotingRUM. 8. The health sector faces a critical shortage of qualified pharmaceutical personnel to managemedicinessupply,dispensinganduse.WithabouttwothirdsofpublicandFBHS facilities lacking qualified personnel, pharmaceutical services are deficient: stockͲouts, inadequaterecords,inadequatedispensingpracticesandirrationaluseareconsequences ofskewedprioritiesanduncoordinatedinvestmentinpharmaceuticalservices. 9. Regulationsgoverningpharmaceuticalservicesarenoteffectivelyenforcedinthepublic andFBHSsectors;andtoalesserextenttheprivatesector.Thisisaseriousthreatbothto publicsafetyandqualityofpharmaceuticalservicesdelivery. 10. Licensed private pharmacies have a significant role in improving access to medicines. Basicessentialmedicinesareavailable,fairlyaffordableandlargelydispensedbyqualified personnel;andthesectorscoreshigheronmostdispensingindicators.

Overall, findings of this survey indicate stagnating or deteriorating performance of the publicsectorsince2003.Whereasavailabilityhasnotchangedsignificantly,stockͲoutsin facilitieshaveincreased;andstockrecordsandlabellingofmedicineshavedeteriorated.

3 RECOMMENDATIONS Arisingfromthefindingsandconclusionsofthesurveyandwithinthecontextofthestated aims and objectives of the KNPP, the following are key recommendations addressed to Government,DevelopmentPartners,CivilSociety,FBHSandthePPB: TotheGovernment a) Institutionalizeandintegratemonitoringandevaluationofpharmaceuticalserviceswithin thehealthsectorcoordinationandM&Eframework,toinformpoliciesandstrategiesfor improvingaccesstomedicines. b) Rationalize priorities and investments across the entire spectrum of pharmaceutical serviceswithintheKEPH,totargetthediversegapsinaccesstomedicines.Thiswould includepersonnelandstorageinfrastructureinlinewithdefinednormsandstandards. c) Developpoliciestopromotetheuseofqualityassuredgenericproducts,asameansof sustainingaffordabilityofessentialmedicines. d) Deploy qualified personnel to public and FBHS facilities in compliance with the law, to safeguardpatientsafetyandimprovemedicinesmanagement,prescribinganddispensing. e) Prioritizetheupgradingofmedicinesstorageinfrastructurein thehealthinfrastructure improvementplan,withparticularfocusonKEMSA,publicandFBHShealthfacilities. f) DevelopandimplementacoordinatedstrategytopromoteRUM.Thismayinclude: g) Sustain and enhance the efficiencies of public and FBHS pharmaceutical procurement, throughcollaborativemechanismssuchascoordinatedͲinformedbuying. h) Intheelaborationofhealthfinancingpolicies,ensurethatcoverageformedicinesisin linewiththeEssentialMedicinesConcept;andthatfinancialbarriersareeliminatedto thegreatestextentpossible. i) Enhance coordination of pharmaceutical issues within health sector coordinating framework,tofacilitatecomprehensivestrategiesandinvestmentsthatcapturethefull scopeofpharmaceuticalswithinoverallhealthsectorstrategicframework. ToDevelopmentPartnersinHealth–Kenya(DPHͲK) a) FacilitateacoordinatedandevidenceͲbasedapproachtopharmaceuticalservicessupport, inthecontextofexistinghealthsectorcoordinatingandinvestmentmechanisms. b) Support coordinated pharmaceutical sector M&E – including periodic comprehensive pharmaceuticalsituationassessmentsͲandintegrateintoongoingprogrammes. c) EnhancesupporttohumanresourcesforpharmaceuticalservicesinthepublicandFBHS sectorswithinthecontextoftheHumanResourceforHealthStrategicPlan. FaithBasedHealthServices(FBHS) a) In consultation with Government and Development Partners, institute mechanisms to improveaffordabilityofkeymedicinesinFBHSfacilities,inamannerthatsupportsand maintainshighavailability.Thismayinvolveexpandedsubsidizationandrationalizationof currenthealthsectorinvestmentsonpharmaceuticals. CivilSociety a) Advocate for and support evidenceͲbased programming and investment in pharmaceuticalservices. b) EnhanceconsumerawarenessonthecorefactorsaffectingaccesstoEssentialMedicines, andtheirroleinimprovingappropriateuseofmedicines. Pharmacy&PoisonsBoard a) Enforcefullcompliancewiththelawonthehandlinganddispensingofmedicines.This shouldapplyequallytothepublic,FBHSandprivatesectorhealthproviders. b) LiaisewiththeKMPDBtoensurethatmedicines’prescribingcomplieswiththelaw.

4 1.INTRODUCTION 1.1BACKGROUND AccesstomedicinesispartofthefundamentalRighttoHealth,anditsattainmentisapreͲ requisitetoachieveuniversalaccesstohealthservices.Accesstomedicinesimpliesaccessto EssentialMedicinesasdefinedbyWHO: Essentialmedicinesarethosethatsatisfythepriorityhealthcareneedsofthepopulation.Theyare selectedwithdueregardtodiseaseprevalence,evidenceonefficacyandsafety,andcomparative costͲeffectiveness.Essentialmedicinesareintendedtobeavailablewithinthecontextoffunctioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality,andatapricetheindividualandthecommunitycanafford(WHO2002).

Thedevelopment,implementationandregularupdatingofanationalpharmaceuticalpolicy underscore Government's commitment to ensure access to medicines for its population. Suchapolicyshouldaddressprimarydeterminantsinthedevelopment,production,selection, pricingandfinancingofessentialmedicines;theregulatoryframeworkforassuringmedicines quality,safetyandefficacy;aneffectivesupplysystemthatensuresavailabilityandrational use;andoverallgovernanceoffunctionalandadministrativeprocesses.Accesstomedicines wouldthereforeimplytheavailability,affordability,quality,andappropriateuse(handling, prescribinganddispensing)ofEssentialMedicines.

Assessment, monitoring and evaluation underpin evidenceͲbased policy development and strategic planning. The complexity of the pharmaceutical sector, with multiple and crossͲ cuttingfactorsthatcaninfluenceaccesstoandrationaluse1ofqualitymedicines,makesitis extremely important to have a standardized and systematic method for assessing the pharmaceutical situation at country, regional and global levels. Pharmaceutical sector assessment,monitoringandevaluationaimtoanswerthefollowingvitalquestions: x Dopeoplehaveaccesstoessentialmedicines? x Arepeopleobtainingmedicinesthataresafe,effectiveandofgoodquality? x Arethesemedicinesbeingprescribed,dispensedandusedproperly? Aspartofitsmandatetoprovidetechnicalsupportinthemonitoringofhealthtrends,WHO has developed standardized methodologies for monitoring and assessing the national pharmaceuticalsituation,which requiresystematicsurveysanddatagatheringathealthcare facilities. In order to ensure their relevance and applicability to diverse country situations, thesetoolsareperiodicallyreviewedinconsultationwithglobalexpertsandusingfeedback fromcountriesthathaveundertakensuchassessments,aswellastrainersandexpertswho haveusedthesurveytools.TheWHOtoolsareintendedtobeusedasguidesforcountriesto

1RationalUseofMedicines:Patientsreceivemedicationsappropriatetotheirclinicalneeds,indoses thatmeettheirownindividualrequirements,foranadequateperiodoftime,andatthelowestcost to them and their community." (WHO, 1985). The term is used in this report synonymously with AppropriateUseofMedicines

5 adapt to their specific situation. They enable the measurement of standardized indicators whichcanbegroupedintoamultiͲlevelindicatorpyramidasshowninFigure1below. Figure1:Coreindicatorsusedtomonitorandassess thenationalpharmaceuticalsituation

LevelI Level1 Corestructure Keyinformantquestionnaire Corestructure senttocountries &process indicators LevelII Coreoutcome/Levelimpact2 indicators Systematicsurvey AccessCoreoutcome/toessentialimpactmedicinesindicators (healthfacilitiesand • Accesstoessentialmedicines RationalUseofMedicines households) • RationalUseofMedicines LevelIII IndepthassessmentsLevofelspecific 3 componentsofthe Indepthassessmentsofspecificcomponentsofthe Diverse pharmaceuticalsector pharmaceuticalsector methodologies Pricing QualityQuality TRIPSTRIPS HIV/AIDSHIV/AIDS Malaria TraditionalMedicines DrugSupply TraditionalRegulatoryMedicinesCapacity Monitoringofthepharmaceuticalsituationthereforeaimsto: i) assesscountrycapacity(infrastructuresandresources) ii) reviewimplementationstrategiessoadjustmentscanbemade iii) measure outcomes of pharmaceutical objectives (access and rational use of quality medicines) iv)evaluateprogresstowardsidentifiedobjectives. ThevariousindicatorsprovidepolicyͲmakersandmanagerswithaclearpictureofnational andinstitutionalperformance,capacitiesandgapsinensuringaccesstoessentialmedicines. PolicyͲmakers and managers can refer to study results when developing strategies to strengthenthepharmaceuticalsector.Resultscanalsobeusedtosynchronizepolicyactions relatedtopharmaceuticals.

Level II indicators are measured in public health facilities, private drug outlets and in warehousessupplyingthepublicsector.Othersectorswhichprovideasignificantproportion ofhealthservices(e.g.theFBHSsectorinKenya)shouldalsobeincluded.Theymeasurethe expected outcomes and impact of strategic pharmaceutical programmes in a country: improvedaccess,qualityandrationaluse.

The availability and affordability of essential medicines are assessed in all sectors, but especially in the public sector where the majority of the poor access healthcare. The presenceofexpiredmedicinesonpharmacyshelvesaswellastheadequacyofhandlingand conservation conditions are used as proxy indicators of the quality of medicines made

6 available to the population, since determination of the actual quality of medicine samples wouldbenotbefeasibleunderthesurveyconditions.Finally,rationaluseismeasuredby examiningtheprescribinganddispensinghabitsofhealthprovidersandtheimplementation ofkeystrategiessuchasthepresenceanduseofstandardtreatmentguidelines(STG)and essentialmedicineslists(EML). Thissurveyundertakenin2008usingthestandardizedWHOmethodologiesistodatethe second to be carried out, the first having been undertaken in 2003 which was able to establishsomekeybaselinefiguresagainstwhichsubsequentprogresscouldbemeasured.It isrecommendedthatsuchsurveysshouldberepeatedatleastonceeveryfouryearsinorder to maintain an accurate profile of the pharmaceutical sector and thereby provide a vital evidence base for use in formulating and developing pharmaceutical policy and related strategicinterventions. 1.2IMPLEMENTATIONOFTHESURVEY InSeptember2008,anationwidestudyofthepharmaceuticalsituationwasundertakenin government health facilities, FBHS health facilities, private pharmacies, and warehouses supplyingthepublicandFBHSsectorsinKenya.Thestudywasconductedusingstandardized methodology developed by the World Health Organization (WHO) to assess the pharmaceuticalsituationathealthfacilitylevel(i.e.theWHOLevelIIAssessment).Thisisan indicatorͲbasedsurveythatprovidessystematicdataonaccess,rationaluseandqualityof medicinesthroughafacilityͲbasedapproach. 1.3OBJECTIVES The main objectives of the study were to obtain information on the status and outcomes relatedtothefollowingkeymedicinespolicyquestionswithregardtoKenya: x Aremedicinesthatareusedtotreatcommonconditionsatprimarycarelevel,available andaffordableingovernment,FBHSandprivatedispensingfacilities? x Do people have adequate geographical access to government, FBHS and private dispensingfacilities? x Arethereexpiredmedicinesingovernment,FBHSandprivatedispensingfacilities? x Aremedicinesproperlystoredandhandledingovernmenthealthfacilities,FBHSfacilities, privatepharmaciesandcentralwarehousessupplyingthegovernmentandFBOsectors? x Aremedicinesadequatelyprescribed,labelledanddispensed? x Arepatientsadequatelyinformedonhowtousetheirdispensedmedicines? x Are medicines dispensed by qualified pharmaceutical personnel at health facilities and privatepharmaciesasrequiredbylaw? x Whichpersonnelareprescribingmedicinesinhealthfacilities? x Do prescribers adhere to Standard Treatment Guidelines as part of good prescribing practices? x How is the public sector performing on access to medicines compared to 2003?

7 2.COUNTRYBACKGROUND

Kenya lies along the Equator in Eastern Africa between Somalia and Uganda and borders Tanzania,Sudan,Ethiopiaand theIndianOcean.Thetotalareais582,650sqkmofwhich 13,400 sq km is water. Administratively, the country is divided into 8 provinces and 712 districts,thedistrictbeingthemainadministrativeunitforhealthservicedelivery. Figure2:MapofKenya ©UnitedNationsCartographicSection

Thetotalpopulationwasestimatedat37.2millionin2007,ofwhichabout43%isbelow15 years3.KenyaisalowincomecountrywithaGDPofUS$778percapita(2007).TheHuman DevelopmentIndex(HDI)is0.532,rankingthecountry144thoutof179countriesforwhich dataareavailable;whereastheHumanPovertyIndex(HPIͲ1)of31.4%,ranksthecountry91st among 135 developing countries for which the index has been calculated4. The country’s employmentͲtoͲpopulation ratio (both sexes) was 73% in 20085. According to the Kenya DemographicandHealthSurveyof2008,themeansizeofaKenyanhouseholdis4.2persons; therateofunderͲ5mortalityhasdeclinedfrom92per1,000livebirthsin2003to74per 1,000 live births; while maternal mortality remains high, having increased from 414 per

2The survey was undertaken during an ongoing review of district boundaries at which time 71 districtswererecognized. 3KenyaFactsandFigures,KenyaNationalBureauofStatistics,2008 4HumanDevelopmentReport,UNDP2008Update 5Source:UnitedNationsStatisticsDivision http://data.un.org

8 100,000livebirthsin2003toafigureof 448in20086.Theadult(15+)literacyratewas61.5% in2007beinghigherformales(64%)thanfemales(59%)7.

Table1:KenyaEconomic&HealthIndicators Indicator Value Year Totalpopulation(millions) 37.2 2007 GrossDomesticProduct(GDP)percapita(US$) 778.1 2007 Lifeexpectancyatbirth(M/F)(years) 54/59 2006 HealthyLifeExpectancyatbirth(M/F)years 44/45 2006 Under5mortalityrateper1,000 74 2008 Percapitatotalhealthexpenditure(US$) 27 2006 Totalhealthexpenditure(THE)(asa%ofnominalGDP) 4.8% 2006 Governmenthealthexpenditureasa%oftotalgovernmentexpenditure 6.4% 2007/08 OutͲofͲpockethealthspendingasa%ofTHE 29.1% 2006 Householdhealthspendingasa%ofTHE 35.9% 2006 %ofoutͲofͲpocketexpenditurespentonmedicines 69% 2003 %ofMOHbudgetspentonmedicines&medicalsupplies 11.3% 2006/07 Sources:KenyaNationalHealthAccounts(2005/06) KenyaHouseholdHealthExpenditureandUtilizationSurvey(2009) 2.1HEALTHSECTOR 2.1.1Healthstatusandindicators KeyhealthimpactindicatorssuggeststagnationordeclineinthehealthstatusofKenyans. Thisisattributabletothehighdiseaseburdenduetoexisting,andnewconditions,andan inadequate response to manage the disease burden. The health impact indicators also suggest wide disparities in health across the country, closely linked to underlying socioͲ economic,genderandgeographicaldisparities.LowimmunizationcoverageandcrossͲborder socialdisturbancesintherecentpasthavealsoseentherecurrenceofmeaslesandpolio, whichhad beenbroughtundercontrol.The mainhealthchallengesin thecountryinclude HIV/AIDS,malaria,tuberculosisandnonͲcommunicablediseases.Malariaprevalenceis14%8, and it is the leading cause of morbidity (30%), followed by respiratory diseases (24.5%)9. NationalHIVprevalenceis7.4%andanestimated1.4millionadultsarelivingwithHIV.Only 35% of those in need of ART are accessing treatment10. TB prevalence is 319 per 100,000 againstanMDGtargetof63;48%ofTBcasesarecoͲinfectedwithHIVandthereisagrowing threatofMDR/XDRͲTB11. GeneraldataaresummarizedinTable1above.

6KenyaDemographicandHealthSurvey,2008Ͳ09 7KenyaNationalBureauofStatisticsLiteracySurvey2007 8KenyaMalariaIndicatorSurvey2007 9HealthManagementInformationSystem2008 10KenyaAIDSIndicatorSurvey2007 11WHOGlobalTuberculosisControlReport2009

9 2.1.2Healthpolicyandstrategicplanning TheKenyaHealthPolicyFramework(KHPF1994Ͳ2010)istheoverarchinghealthpolicyforthe country.ItsoverallgoalistopromoteandimprovethehealthstatusofallKenyansthrough thedeliberaterestructuringofthehealthsectortomakeallhealthservicesmoreeffective, accessibleandaffordable.ThesecondNationalHealthSectorStrategicPlan(NHSSPII2005– 2010), was developed with the aim of reversing the declining trends in key health sector indicators, and it has five broad policy objectives: i) increase equitable access to health services,ii)improvethequalityandresponsivenessofservicesinthesector,iii)improvethe efficiencyandeffectivenessofservicedelivery,iv)enhancetheregulatorycapacityofMOH, v) foster partnerships in improving health and delivering services and vi) improve the financingofthehealthsector. Ministerial strategic plans for the Ministry of Public Health and Sanitation and Ministry of MedicalServicesoutlinetheinvestmentdecisionsfortheyears2008–2012forstrengthening thecapacityofthetwoministriestodeliverpublichealth,sanitationandmedicalservicesin linewith Vision2030.Theplans outlinestrategicthrustsforeachMinistry,whichserveto guideinvestmentandprogramminginthekeypriorityareastowardstheoverallgoalsofthe NHSSPII.PlanningforhealthservicesandinterventionsisthroughAnnualOperationalPlans (AOP), capturing the short term actions and expected achievements for all health sector playerswithintheplanningyear.Thesealsoservetoalignhealthplanningwiththenational budgeting process. Lessons learnt from previous AOP development and implementation stagesusuallyinformthefocusandprocessofplanningforthesuccessiveyear.

2.1.3Healthsystemstructure,statusandchallenges ThehealthsectorhasdefinedtheKenyaEssentialPackageforHealth(KEPH)basedonalife cycleapproachtodeliveryofacomprehensivehealthcarepackageacross6levelsofcare. Figure3:HealthSectorPyramid

Source:NormsandStandardsforHealthServiceDelivery,MOH,2006 The Government is the main provider of health services, accounting for about 52% of all health facilities. The private forͲprofit and the privateͲnotͲforͲprofit providers also serve a significant proportion of the population, accounting for 34% and 14% of health facilities

10 respectively12.ToguidetheimplementationofKEPH,thehealthsectorelaboratedNorms& Standards13for healthcare delivery, which defines the minimum and appropriate mix of humanresourcesandinfrastructurerequiredtoensuretheefficientandeffectivedeliveryof defined health services at the different levels of the health system. RollͲout of KEPH is hampered by inadequate quantities and qualities of resources (human, infrastructure, financial)andstillevolvinginstitutionalcapacitytomanagetheavailableresources. 2.1.4Healthpartnershipandcoordination According to the National Health Accounts14, 29.3% of health expenditure is public, with 31.0%fromdonorsand35.9%fromhouseholds.Coordinationmechanismsarecontinuously beingstrengthenedbetweenthevariouspartners,withaCodeofConductguidingpartner engagementinthesector.Themajordevelopmentpartners15cametogetherundertheJoint Support Programme to design areas of focus for their support. There is also active engagement with the formal faithͲbased16and the nonͲgovernmental service providers. Underlying socioeconomic factors and crossͲborder issues require a broaderͲbased partnershipplatform,encompassinggovernance,politicalreformandregionalcollaboration toaddressunderlyingdeterminantsofhealthandtotacklecrossͲborderhealthchallenges. 2.2PHARMACEUTICALSECTOR ThefollowingarekeyfactsandfiguresonthepharmaceuticalsectorinKenya.

Table2:KeyPharmaceuticalSectorIndicators Indicator Value Year DateofNationalDrugPolicy 1994* 2010* DateofNationalEssentialMedicinesList 2002* 2010* DateofStandardTreatmentGuidelines 2002* 2009* Publicsectormedicinesexpenditure(US$) 16million 2002/3 Publicsectormedicinesexpenditurepercapita(US$) 0.51 2002/3 %ofMOHrecurrentbudgetspentonmedicines&medicalsupplies 11.3% 2006/7 PharmaceuticalsubͲsectorvalue(US$)(PPB) 130million 2004 Numberofregisteredpharmaceuticalmanufacturers 45 2009 Numberofregisteredretailpharmacies 1,279 2008 Numberofregisteredpharmaceuticalwholesalers 212 2008 Numberofregisteredpharmaceuticalproducts 12,008 2009

12FactsandFiguresonHealthandRelatedIndicators,MinistryofMedicalServices,2009 13NormsandStandardsforHealthServiceDelivery,MinistryofHealth,June2006

14KenyaNationalHealthAccounts2005/06,March2009 15MajorDevelopmentPartnersincludeDANIDA,DfID,GDC,ItalianCooperation,SIDA,UNICEF,USG,andthe WorldBank 16A Memorandum of Understanding (MoU) exists between the Government and the FaithͲBased Health Services (FBHS), which recognizes their important contribution, prevailing status, challenges and potential to contribute towards attainment of MDGs and other health goals. It elaborates various forms of collaboration includingGovernmentsubsidiestoFBHS,particularlyforpersonnel,medicinesandinfrastructuremaintenance.

11 Indicator Value Year Numberofpharmaceuticalinspectors 39 2009 Numberofregisteredpharmacists 2,063 2009 Numberofenrolledpharmaceuticaltechnologists 2,323 2009 Pharmaceuticalpersonnelpopulationratio 1:8710 2009 Numberofpharmacistsinbasictraining 280 2009 Numberofpharmacistsinpublicservice 538 2009 Numberofpharmaceuticaltechnologistsinbasictraining 2,655 2009 Numberofpharmaceuticaltechnologistsinpublicservice 226 2009

*UnderrevisionatthetimeoftheSurvey.DateinYearcolumnistheexpectedpublicationdateofanewedition

2.2.1NationalPharmaceuticalPolicy KenyapublishedthefirstNationalDrugPolicy(KNDP)in1994,addressingimportantissues impactingonpharmaceuticalservices.However,therewasnoclearandsustainablestrategy foritsimplementation,andmonitoringandevaluationofitsimpactwereminimal. TherevisedKenyaNationalPharmaceuticalPolicy(KNPP)of201017whosegoalisUniversal Access to quality pharmaceutical services, Essential Medicines and essential health technologiesinKenya,outlinesrelevantpolicydirectionandstrategiesforthepharmaceutical sector,andthekeyinstitutionalframeworkrequiredtoensureaccessto,andrationaluseof, essential medicines by the population. A 5Ͳyear Pharmaceutical Strategic Plan for KNPP implementation is under development; and implementation plans are developed annually, integratedwithinthehealthsectorAnnualOperationalPlans(AOPs). A baseline assessment of the pharmaceutical situation was undertaken in 2003 18and repeatedin2008usingWHOstandardtoolsandmethodology.The2008assessmentcovers theoverallpharmaceuticalsituation,withtwoseparatereportscoveringtheperspectivesof thehealthsystem(thisreport)andofhouseholds.Acomprehensivemedicinepricesurvey was undertaken in 200419and a medicine price component study in 200720. Quarterly monitoringofmedicinepricesandavailabilityisinplace,coordinatedbytheDepartmentof Pharmacy21.

2.2.2Regulatorysystem Kenya’smedicinesregulatoryauthorityisthePharmacyandPoisonsBoard(PPB).Itisfunded through the exchequer and through fees from regulatory services (e.g. registration of medicines,inspectionandlicensing)andfortheissuingofprofessionalandpracticelicenses. Regulatorypersonnelaresubjecttothecivilservicecodeofconduct,butnospecificlegal provisionsexistrequiringtransparencyandaccountabilityandpromotingacodeofconduct inregulatorywork.Themedicinesregulatoryauthorityprovidesinformationonlegislation,

17Expecteddateofpublication 18 Assessment of the pharmaceutical situation in Kenya: a baseline survey, Ministry of Health/WHO/HAI,2003 19ASurveyofMedicinePricesinKenya,MinistryofHealth,2004 20PricecomponentsandessentialmedicinesinNairobi,Kenya,WHOKenya2007(unpublisheddraft) 21MonitoringMedicinesPricing&Availability(MMePA)inKenya,undertakenquarterlysince2006

12 regulatoryprocedures,prescribinginformation(suchasindications,contraindications,side effects,etc.),authorizedcompanies,and/orapprovedmedicines.

Legal provisions exist for marketing authorization, and registration fees differ between importedandlocallyproducedmedicines.Acumulativetotalof12,009medicinalproducts have been approved for marketing to date and a list of all registered products is publicly accessible on the PPB website 22 . Legal provisions are in place for the licensing of manufacturers, wholesalers, distributors, importers or exporters of medicines; and for regulation of medicines promotion and advertising. Regulatory procedures are in place to ensurethequalityofimportedandlocallymanufacturedmedicinesaspartoftheregistration process.A qualitymanagementsystemwith anofficiallydefinedprotocolforensuringthe qualityofmedicinesisnotinplaceinKenya.Evenso,medicinessamplesareroutinelytested aspartoftheregistrationprocessandsometimesforpostͲmarketingsurveillance.Inasurvey ofthequalityofantimalarialmedicinesinthemarketin2006,43batcheswerequalitytested, with16%failingtomeetqualitystandards. Legal provisions are in place for the licensing and practice of prescribers, pharmaceutical personnelandpharmacies.Nolegalprovisionsexistrequiringtheprescribingofmedicinesby generic name or obligating the dispensing of generic medicines in any sector. Generic substitutionispermittedinpublic,FBHSandprivatepharmaciesandthroughtheessential medicines concept, the public and FBHS sectors encourage the dispensing of generic medicines.

2.2.3Medicinessupplysystem PublicandFBHSpharmaceuticalprocurementispooledatthenationallevelwithseparate centralizedprocurementsystemsservingprimarilythepublicandFBHSfacilitiesrespectively. The public supply chain has two systems in place – a kitͲbased (push) system and an inventoryͲbasedordering(pull)system.Thepullsystemwhichstartedin2005isunderrollͲ out, being fully operational in 3 Provinces.Procurement and distribution of Essential Medicines and Medical Supplies for government is the responsibility of KEMSA, a procurement agency under the Ministry of Medical Services. International competitive tender processes are used for public sector procurement with provisions for alternative methodsinspecifiedcircumstances.Publicsectorprocurementislimitedtomedicinesonthe Essential Medicines List (EML) and any relevant and recently updated standard treatment guidelines. To guide the procurement of medicines for the public sector, the public procurement agency develops and reviews an annual formulary list in consultation with stakeholders. This process aims to fineͲtune the specific products to be procured, derived fromtheEMLand/orotherrelevanttreatmentprotocols.Therearenoregulationsforlocal preferenceinpublicsectorprocurement. The FBHS procurement agency (MEDS) undertakes procurement and supply of essential drugsandmedicalsupplies,toFBHSfacilities,somepublicfacilitiesandotherhealthnotͲforͲ profit healthcare providers. MEDS’ stock list is reviewed periodically by a formulary committee comprising experts in the various health disciplines and clinicians from health facilities, hence the public and FBHS supply lists may be similar, but are not identical. In addition to medicines supply, the FBHS services also involve training of health workers on

22Seewww.pharmacyboardkenya.org

13 various aspects of healthcare, and other capacity enhancement services as part of strengtheninghealthcareprovision.TheFBHSareasignificantandcomplementaryserviceto thatofGovernmentwithfacilitiesthatcompriseasignificantproportionofallhealthfacilities inKenya,mostofwhicharelocatedinremote,ruralandmarginalizedareas. 2.2.4Medicinesfinancing PublicfinancingofthehealthsectorthroughtheexchequerisUS$10.9percapita23,which fallsbelowtheWHOrecommendedlevelofUS$34percapita(ofwhichaminimumof$2.50 should be on essential medicines). This is far short of the Government’s commitment to spend15%ofthenationalbudgetonhealth,asagreedintheAbujaDeclarationsof2001and 2006. Such underͲfunding has reduced the sector’s ability to ensure an adequate level of service provision to the population, and has led to significant levels of outͲofͲpocket expenditure. For example, households accounted for 36% of the total health expenditure (THE)in2005/06andofthis,29%wasoutͲofͲpocket.Costsharingaccountedfor7.4%ofthe Ministry’srecurrentexpendituresin2005/200624,andthiscontributestoinequityinaccess tohealthcareforthepooranddisadvantagedgroups.

There is a national policy (the ‘10/20 policy’) that requires public primary care facilities (Levels2&3)toprovidehealthcare(includingmedicines)freeofcharge,withpatientsonly paying minimal registration fees25. Children under 5 years are entitled to free health care (includingmedicines)inpublicandFBHSfacilitiesandawaiversystemisinplaceforpatients whocannotaffordtreatment.Publiclyprocuredmedicinesforpriorityhealthprogrammes, suchascontraceptivesandmedicinesformalaria,HIV/AIDSandTB,arealsoprovidedforfree throughpublicandFBHSfacilities.Costsharingappliesfortreatmentofotherconditionsin adultsandchildrenover5years,atlevels4Ͳ6inthepublicfacilities.Revenuesfrompatients’ feesormedicinessalesareneverusedtopaythesalariesorsupplementtheincomeofpublic healthpersonnelinthesamefacility.FBHSfacilitieschargeforthecostoftreatmentformost conditions,butsomeprovisionsexistforsubsidiesandwaivers.Theprivatesectorprovides healthservicesͲincludingmedicinesͲonafullcostͲrecoverybasis.Prescribersinthepublic andprivatesectorssometimesdispensemedicines. InKenya,onlyabout10%ofthepopulationhassomeformofhealthinsurance.Amongstthe insured,theNationalHealthInsuranceFund(NHIF)hasthewidestcoverageofabout84% overall, and it covers all or part of inͲpatient treatment, but does not cover outͲpatient medicines. About 8% and 12% of the population has private or employerͲbased health insurancerespectively,whichcoverssomeorallmedicinescosts26.Thereisnopolicytoguide thepricingofmedicinesinanysector,butpubliclyprocuredmedicinesarehighlysubsidized. Thereisnoimporttaxonpharmaceuticalrawmaterialsorfinishedproducts; however,the Government levies a 2.75% fee on all imported medicines for processing of import documentation,i.e.theImportDeclarationForm(IDF)fee.

23FactsandFiguresonHealthandRelatedIndicators,MinistryofMedicalServices,2009 24AdaptedfromtheHealthSectorReport2007 25RegistrationfeeatLevel2(Dispensary)andLevel3(HealthCentre)isKES10(equivalenttoUSD 0.14)andKES20(USD0.28)respectively. 26KenyaHouseholdHealthExpenditureandUtilizationSurvey,MinistryofHealth,2007

14 ThenationalEMLdoesnotplayadirectroleinthesettingofmedicinepricesintheprivate sector,andpricesettingisnotpartofmarketingauthorization.Kenyahasanationalmedicine price monitoring system for retail/patient prices. There are no regulations mandating retail/patient medicine price information to be made publicly accessible. There are official writtenguidelinesonmedicinedonationsthatproviderulesandregulationsfordonorsand provide guidance to the public, private and/or NGO sectors on accepting and handling donatedmedicines27. 2.2.5Rationaluseofmedicines ThenationalEssentialMedicinesList(EML)isthebasisforpublicsectorprocurement.The EML was last updated in 2002, and it was under revision at the time of the survey, with reference to the most current WHO Model List. The National Medicines and Therapeutics Committee(NMTC)isresponsibleforspearheadingtheselectionofproductsonthenational EML,althoughitwasnotfunctionalatthetimeofthesurvey.Thehealthministryproduces nationalStandardTreatmentGuidelines(STG)formajorconditions.Thesewerelastupdated in2002,andwerealsounderrevision.However,somediseaseͲspecificguidelinesforpriority healthprogrammeshavebeenupdatedmorerecently.Antibioticsarefrequentlysoldover thecounterwithoutaprescription,andeveninjectionsareoccasionallyalsosoldinthisway.

27KenyaNationalGuidelinesonDonationsofDrugsandMedicalSupplies,MinistryofHealth,March2001

15 3.STUDYDESIGNANDMETHODS

ThisstudywasconductedusingthestandardizedWHOLevelIIAssessmentmethodologyfor health facilities. This is an indicatorͲbased survey that applies standardized data collection forms, which enable calculation of the indicators. A survey advisory group adapted the standardizedformstothecountrysituation,andprovidedtechnicaloversightthroughoutthe surveydesign,fieldwork,datainterpretationandreportwriting.Thesurveymethodologyhas acomponentonpatientpricesofessentialmedicines,but,aspartofongoingmonitoringof pharmaceutical services, a Monitoring of Medicines Prices and Availability (MMePa) was already in place, undertaken quarterly by the Ministry, using a methodology jointly developed by WHO and HAI. To avoid unnecessary data duplication, the advisory group deemed it necessary and preferable to integrate the monitoring into the survey process, hencedatacollectionforthecoincidingquarterofMMePAwassynchronizedwiththesurvey. 3.1SAMPLING 3.1.1Sectorssurveyed ThesurveycoveredthethreemainhealthserviceprovidersinKenya,i.e.thegovernment, faithͲbasedandprivatesectors,asdefinedinthehealthsectorcoordinationframework. 3.1.2Samplingofregions(provinces) Sixprovincesandthreelocationswithineachprovince,wereselectedas"surveyareas"for datacollection.Themajorurbancentreandcapitalcity(Nairobi)waspurposivelyselectedas onesurveyareawhileNorthEasternwasselectedasrepresentativeofalowincomearea. OtherprovincesselectedwereCoast,RiftValley,NyanzaandWestern.Centralprovincewas excluded from the sample due to its similarity to Nairobi province whilst parts of Eastern provincewereconsideredtoberepresentedbyNairobi,CoastandNorthEasternprovinces. 3.1.3Samplingofdistricts To sample the districts, a stratified sampling technique was adopted where three districts were chosen from each province, one being the location of the largest hospital and two othersselectedrandomlyusingtherandomnumberfunctioninMicrosoftExcel®. Table3:ListofSampledDistricts TwootherDistricts Province LargestHospital District selectedrandomly Nairobi KenyattaNationalHospital Nairobi Nairobi RiftValley NakuruPGH Nakuru Narok,Baringo Nyanza NyanzaPGH Kisumu Bondo,Rachuonyo Western KakamegaPGH Kakamega Busia,Bungoma Coast CoastPGH Mombasa Kilifi,TanaRiver NorthEastern GarissaPGH Garissa Mandera,Wajir

16 3.1.4Samplingoffacilities The sample of six government facilities per province was identified as follows: the largest public hospital, then from the two other selected districts, all government hospitals were listedandoneprimaryhospitalselectedrandomly.Similarly,onehealthcentrewasselected fromthethirddistrictfromwhichnohospitalhadbeenselected.Tocompletethelist,allthe publicdispensariesfromthethreedistrictswerelisted,andthreegovernmentdispensaries wereselectedatrandomfromthelistwhilstensuringthatnotmorethantwofacilities(of anytype)wereselectedperdistrict.AsimilarprocesswasusedforFBHSfacilities,i.e.the largest FBHS hospital in the province, a second hospital (or large Health Center) from a different district, a dispensary sampled randomly from the same district as the largest hospital and another from same district as the 2nd hospital, and two facilities sampled randomlyfromthethirddistrict.Thisprocessyieldedthecompletelistofgovernmentand FBHSfacilitiestobesurveyed(seeAnnex5,p74).

Samplingofprivatepharmaciesentailedselectingtheprivatelicensedpharmacynearestto each selected government facility. Licensing status was established by referring to the current list of registered facilities obtained from the Pharmacy & Poisons Board (PPB). AdditionallythetwocentralwarehousesthatsupplythepublicandFBHSsectorrespectively wereselected,resultinginatotalsampleof36governmenthealthfacilities,36FBHShealth facilities,36privatepharmaciesand2centralwarehouses.

3.1.4Selectionofpatients Prospectivesamplingwasusedtocollectpatientcaredata.Foreachfacilitysurveyed,thirty patientswereidentifiedforinterviewing(afterobtainingverbalconsent)astheywereleaving thedispensingarea/pharmacyorleavingthefacilityaftertheyhadbeentreatedandreceived medicines.Thiswasdonewithoutdisruptingthenormalactivitiesofthefacility. 3.1.5Selectionofprescriptions Retrospective sampling of prescriptions was used to collect data on prescribing indicators. ThirtypatientencountersweresampledbyrandomselectionofoutͲpatientrecordsfromthe previous12monthperiod. 3.1.6Selectionofmedicinestosurvey Verificationofmedicinesavailability,stockoutandexpirywasbasedonacorelistofbasic medicines,selectedaccordingtothefirstͲlinetherapeuticchoicetotreatthemostcommon and important health conditions at the primary health care level. Availability was also measured using medicines on the MMePA list to enable comparison of medicine prices in Kenya with those in other countries. In measuring the affordability of treatments, the advisorygroupoptedtoincludehumaninsulinandbeclomethasoneinhaler(formanagement of insulinͲdependent diabetes and asthma in children respectively), on the premise that thesemedicineswereunaffordable,althoughtheywouldonlybesuppliedthroughhospitals. 3.2DATACOLLECTION 3.2.1Organizationofdatacollection The Ministry of Medical Services and the Ministry of Public Health and Sanitation, both organizedandgaveapprovalforthesurvey.Toobtainspecificapprovalandcooperationfor

17 datacollection,formalcommunicationwassenttotheProvincialMedicalOfficersandheads ofthesampledfacilities.Thesurveyteamscarriedcopiesofthiscommunication.

3.2.2Adaptationoftools Thesurveyformswereadaptedbyconsideringthenationalstructuresandprocessesinplace inthehealthsector,inordertoensurethatdataandfindingscanbeadequatelyinterpreted. ForeachcategoryoffacilitysurveyeddatawascollectedusingasetofSurveyForms(Annex2, p57). Annex 1, p56 summarizes the Level II indicators and lists the corresponding survey formswhereinformationondatacollectionandcalculationcanbefound. 3.2.3Selectionandtrainingofdatacollectors Pharmaceutical staff comprising pharmacists, pharmaceutical technologists and pharmacist internswerechosenasdatacollectors(seeAnnex4).Thesupervisorswerepharmacistswith knowledge of the Kenya pharmaceutical subͲsector in general and knowledge of health facility management including pharmaceutical procurement and supply systems. They providedlogisticalsupportto,andtechnicaloversightof,thedatacollectionprocess.

Thefieldteamcomprised26datacollectorsand2supervisors.Datacollectorswereselected andassignedtothesurveyprovincestakingintoaccountabilitiestocommunicateinthelocal languages.Theselectionalsoaimedtoachieveacombinationoflocaldatacollectorsfrom the various provincesͲ so as to resolve concerns the data collectors may have had about travelingtounfamiliarareasͲandnationaldatacollectorstominimizebias(realorperceived). Thefieldteamweretrainedtogetherwithdataentryclerks,duringa5Ͳdaytrainingheldin Nairobifrom8Ͳ12September2008.Thetrainingcoveredsurveymethodologyandtools,and alloweddatacollectorstoparticipateinfinaladaptationandfieldͲtestingofthetools,aswell asbriefingthemontheirspecificrolesandsurveylogistics.

3.2.4DataCollection Datawascollectedoveraperiodofthreeweeksfrom22Septemberto10October2008.Data collectorsweredividedintoseventeams,sixofwhichcoveredaprovinceeach,andateamof two covered the central warehouses. The teams that went out to the provinces had four members each including the team coordinator who was liaising with the supervisors. The central warehouses team collected data over a one week period. Data collection entailed observationsguidedbycheckͲlists,reviewofclinicalandpharmacyrecordsandinterviewsof healthworkersandpatientsafterobtainingtheirverbalconsent.

Somefacilitiessampledwerenotsurveyedduringtheactualfieldwork.Somewerefoundto be nonͲoperational or inaccessible for security reasons while others had an inadequate numbers of interviewees. The team leaders and survey supervisors would the consult to identify alternate facilities, taking into account their similarity with the facilities initially sampled, and their accessibility by the data collectors. This problem was mainly found in NorthͲEasternprovinceandespeciallyforFBHSfacilities.Mostinterviewdatawascollected from adult patients, comprising a higher proportion of females (54%). Annex 3 shows the characteristicsofoutͲpatientsinterviewed. 3.3DATAENTRYANDANALYSIS On each survey form, the relevant indicator measures were calculated manually and recordedontheform.AfterreviewofcompletedSurveyFormsbythetwodesignatedsurvey

18 supervisors, the data summaries were entered into the standard Workbook, both in MS Excel®andinfreewareprovidedaspartoftheWHOsurveypackage,whichenabledindicator calculation.FordataondrugpricesandaffordabilitytheWHOͲHAIworkbookwasused28. 3.4MONITORINGOFMEDICINEPRICESANDAVAILABILITY(MMEPA) This is an ongoing quarterly exercise, undertaken by the Department of Pharmacy in the Ministry of Medical Services in collaboration with WHO and HAIͲAfrica since 2006. The methodology used was jointly developed by WHO and HAI; and adapted to the country situationbyanationaladvisoryteam.Dataiscollectedquarterlyinfourprovinces,from32 health facilities comprising public, FBHS and private pharmacies.Data collectors are pharmaceutical personnel based within the survey regions. They visit each facility every 3 months,andtheycollectthedatausingmanualstandardizedforms,whicharesentanalysis usingastandardizedExcelWorkbook. 3.5LIMITATIONSOFTHEDATA TheWHOLevelIIcoreoutcomeindicatorsurveyhasbeendesignedtoprovideapictureof the national pharmaceutical situation, using relevant information from an as simpleͲasͲ possible data collection process and small sample size. The regions and facilities selected cumulatively represent the national situation. The study is not intended to give a detailed analysis of the pharmaceutical sector but rather to provide an overview of the national situationinthecountry,tohelpinpolicyanalysisanddesignofappropriateinterventionsfor improving access to medicines. Whereas larger sample studies would give more precise results, they would be costly, timeͲconsuming and require more complex logistics. Sample sizeisthereforeabalancebetweenwhatisdesirableandwhatisfeasible.Thebestsample sizeisthesmallestoneprovidingdatawiththedesireddegreeofprecision.Moredetailson samplebiasanderrorcanbefoundintheAnnex2boftheManual29.

ThesamplesizesusedarenotlargeenoughtoenableinterͲfacilitycomparisons.Forexample, forpatientcareindicators,suchcomparisonswouldrequireaminimumsamplesizeof100. This survey uses a sample size of only 72. However, providing that majority of the data is collected and the results are statistically different, comparisons between geographical regions (provinces) can be made. These may be of interest where a group of related indicatorsshowswidevariationorcontrast.Regionalcomparisonsshouldbedonecautiously as not all provinces are represented. OverͲemphasis on the six provinces included in the studymaydetractfocusfromthestudy’ssignificanceasanationalsurvey.

Medicine prices are mostly presented as medians instead of means (with standard deviations). Medians and percentiles are less sensitive to extreme values than means (averages)andarethusthebestsummariesofskewedindicatordata.Themethodologyfor measuringavailabilityonlyenablesmeasurementataspecificpointintime(crossͲsectional), and refers to the situation on the day of the survey. Availability should be interpreted in relationtoconcurrentdataonstockͲoutdays,whichencompassesdataspanning12months.

28Measuringmedicineprices,availability,affordabilityandpricecomponents,WHO&HAI,WHO, Geneva,Switzerland,2008 29WHOOperationalpackageforassessing,monitoringandevaluatingcountrypharmaceutical situations:Guideforcoordinatorsanddatacollectors,WHODecember2007

19 4.RESULTSANDDISCUSSION 4.1DEFINITIONOFTERMSANDCONCEPTS

MedianPriceRatio(MPR) Results on medicine prices gathered by the WHO/HAI survey are usually expressed as “median price ratios” or MPRs. The MPR is a ratio of the local price divided by an internationalreferenceprice(convertedintothesamecurrency).Forexample:anMPRof2 meansthepriceinKenyaistwicetheinternationalreferencepriceandanMPRof0.5means thepriceinKenyaishalftheinternationalreferenceprice.

Thereferencepriceservesasanexternalstandardforevaluatinglocalprices,andallowsfor comparison of prices between countries and regions. The MPR results in this survey are based on reference prices taken from the 2008 Management Sciences for Health (MSH) InternationalDrugPriceIndicatorGuide30.TheMSHGuidepoolstogetherinformationfrom recentpricelistsoflarge,nonͲprofitgenericmedicinesuppliers.Thesesupplierstypicallydo notselltoindividualprivatepharmacies.Rather,theysellinbulktogovernmentsandNGOs, andaccordingly,pricesintheMSHGuidetendtobelow.However,theyofferaveryuseful standardagainstwhichlocallyavailableproductscanbecomparedinanycountry.

MinimumDataPointsforAnalysis Four data points for patient prices and one data point for procurement prices are the minimumnumberofdatapointsthatarenecessaryforthefullanalysistobeperformedby the workbook. If there are fewer data points than this, then no calculation of MPR is performed.Availabilityishowevercalculatedforallmedicinesirrespectiveofthenumberof outletsstockingeachmedicine.

UseofMediansandAverages As averages can be skewed by outlying values, median values are generally used (unless otherwise stated) throughout the presentation of results and discussion as a better representationofthemidpointvalue.

ReportingofQuartiles/Percentiles Aquartileisapercentilerankthatdividesdistributioninto4equalparts.Therangeofvalues containingthecentralhalfoftheobservations,thatis,therangebetweenthe25thand75th percentiles(therangeincludingvaluesupto25%beloworabovethemedian)iscalledthe interͲquartilerange.Inthissectiononfindings,wheremediansandinterͲquartilerangesare not presented in tables, the following format will be used to report the number of occurrencesandtheinterͲquartilerange:n=29;25thand75thpercentiles=0.60,0.83.

Availability Thisreferstothephysicalavailabilityofadefinedbasketofmedicines onthedayofdata collection. Availability denotes the proportion of surveyed health facilities in which the medicinewasfound.Theindicatoriscomputedasamedianoftheavailabilitiesofindividual medicinesinthebasket.

30Seehttp://erc.msh.org/

20 Affordability Affordability refers to the cost of treatment in relation to peoples’ income. The WHO/HAI methodology measures affordability as the number of days’ wages for the Lowest Paid Unskilled Government worker required to purchase a course of treatment for an acute diseaseoramonth’streatmentforachronicdisease.Inthissurvey,thedailywageofthe lowest paid unskilled Kenya Government worker (Job Group A) was KES shillings 166.167 (USD 2.045)31at the time of the survey. However, according to the World Development Indicators(2006),46.6%oftheKenyanpopulationlivesbelowthepovertyline32;hence,even whentreatmentsmayappearaffordabletothelowestpaidgovernmentworker,thesewould belessaffordabletothemajorityofthepopulation. 4.2AVAILABILITY Availabilityonthedayofthesurveywasmeasuredontwolevels:i)foralistof15basic(core) medicines for treatment of common conditions at primary health care level, selected specificallywithreferencetoKenya(thecountrylistͲAnnex6,p77);andii)fortheMMePA listof36medicineswhichallowsinterͲcountrycomparisons(Annex7,p77).Amedicinewas recordedasavailableiffoundontheshelvesonthedayofdatacollection.

4.2.1 Availability of basic medicines in government and FBHS health facilities, warehouses,andprivatepharmacies Thestudymeasuredtheavailabilityof15basicmedicinestotreatcommonhealthproblems inpublichealthfacilitydispensaries,privatedrugoutletsandwarehouses.Table4andFigure 4belowillustratethepercentageavailabilityofmedicinesonthecountrylist.

Table4:SummaryofAvailabilityIndicatorsfor15BasicMedicines National Availabilityof 25th 75th National n Median Min Max SD BasicMedicines %ile %ile Mean (%) Governmenthealthfacilities 36 87.0 73.3 93.8 40 100 82.6 15.8 FBHShealthfacilities 36 93.0 86.7 93.3 53.3 100 89.1 10.1 Privatepharmacies 36 93.3 86.7 100 53.3 100 90.7 11.6 Governmentwarehouse 1 100.0 FBHSwarehouse 1 86.7 SD=standarddeviation

31 At the time of the study, the Kenya shilling (KES) exchange rate was 81.2722 to the US Dollar (USD).

32Seehttp://data.worldbank.org/country/kenya

21 Figure4:MedianAvailabilityofEssentialMedicines(countrylist)

%availability Medianavailabilityofkeyessentialmedicines 100 100.0 90 93.0 93.3 80 87.0 86.7

60 Governmenthealthfacilities 50 KEMSA Missionhealthfacilities 40 MEDS 30 PrivateMedicineOutlets

0 1 HealthFacilityType x Themedianavailabilityofthe15basicmedicineswas87%,93%and93%atpublichealth facilities,FBHSfacilitiesandprivatepharmaciesrespectively. x Ofthepublichealthfacilitiessurveyed,availabilitywithinthe25thpercentilewas73%of themedicines;comparedto94%availabilityinthe75thpercentile.Incomparison,FBHS facilitieswithinthe25thpercentilehadupto87%ofthemedicinesavailable;andthosein the75thpercentilehad93%availability. x All (100%) of the surveyed medicines were found at the government warehouse comparedwith87%attheFBHSwarehouse(MEDS). Essential medicines to treat common diseases should be available in all health facilities, especially in public sector facilities providing health services for the poor. These findings indicateanacceptablelevelofavailabilityforbasicmedicinesinallsectorswithslightlylower availabilityingovernmentfacilities.Thispointstoaneedtoimprovemedicinesdistribution andreplenishment,sincethemedicineswere100%availableinKEMSA. 4.2.2AvailabilityofmedicinesontheMMePAlist Table5belowshowsthemedianavailabilityofthe32medicinesonthegloballistinpublic, FBHSandprivatefacilities.

Table5:Medianavailabilityofmedicines(MMePAlist) MedianAvailabilitybySector Government FBHS Private (n=36) (n=36) (n=36) 67% 66% 81% x The median availability was similar for public and FBHS facilities (67% and 66% respectively)andlowerthantheprivatesector(81%) x Inallthesectors,themedianavailabilityofthemedicinesontheMMePAlistwaslower thanformedicinesonthebasiclist.

22 The MMePA list contains essential medicines for a broader range of health conditions. Therefore,loweravailabilityofmedicinesonthismoreextensivelistinfersthat,forthefull rangeofmedicinesonthenationalEML,availabilitywouldbelowerinallsectors.

4.2.3 Percentage of prescribed medicines actually dispensed or administered to patients To measure the degree to which facilities are able to provide prescribed medicines, the proportionofprescribedmedicinesactuallydispensedoradministeredwascalculated.The data is based on exit interviews conducted on a prospective sample of 30 outpatient encounters at each of the surveyed facilities. Patients sampled were those leaving the dispensingareaorleavingthefacilityaftertheyhadbeentreatedandreceivedmedicines. Foreachpatient,thenumberofchemicalentitiesprescribedanddispensedwasrecorded, and the median proportion was computed for each sector. The distribution of the proportionsamongthesurveyedfacilitieswasfurtheranalyzed.Table6andFigure5show thefindingsforthegovernmentandFBHSfacilities.

Table6:Percentageofprescribedmedicinesactuallydispensed oradministeredtopatients

%ofprescribedmedicines National Value dispensed/administered Median Min Max Governmenthealthfacilities 86 41 100 FBHShealthfacilities 98 80 100 x Inthepublicfacilitiessurveyed,86%oftheprescribedmedicineswereactuallydispensed oradministeredtopatients,andhence14%ofprescribedmedicineswerenotprovided. x IntheFBHSfacilitiessurveyed,98%ofprescribedmedicineswereactuallydispensedor administeredtopatients. ThisfindingindicatesthatpatientsseekingtreatmentinFBHSfacilitiesweremorelikelyto receiveallmedicinesprescribed,comparedtothosetreatedinpublicfacilities.

Figure5:Rangeofthe%ofprescribedmedicinesactuallydispensedoradministered

%ofprescribedmedicinesactuallydispensedoradministered

100.0% 100% Facilities 80%

of 66.7% % 60%

40% 30.0%

20% 0.0% 0.0% 3.3% 0.0% 0.0% 0% <25% 25Ͳ50% 50Ͳ75% >75% %rangeofprescribedmedicinesdispensedoradministered

23 x Ofthepatientsinterviewedinpublichealthfacilities,3.3%receivedlessthanhalfofthe prescribedmedicines;while66.7%receivedmorethan75%ofthemedicines. x Patients interviewed in the FBHS facilities received at least 75% of the prescribed medicines. These findings show that patients seeking treatment in government facilities may fail to obtain a significant proportion of prescribed medicines. The potential reasons for patients failingtoobtainallmedicinesprescribedinclude: x nonͲavailabilityorunͲaffordabilityoftheprescribedmedicine x lackoftreatmentguidelinesand/orformularyinthefacilitytoguideprescribing x lack of adherence to existing guidelines/formulary in the procurement, prescribing and dispensingofmedicines

4.2.4MedicinesStockͲoutDuration Frequent or prolonged stockͲouts affect the ability of patients to obtain medicines as and when required. Therefore, retrospectively measuring the duration of stockͲouts is another approachtoassessingavailability.Thisentailedexaminingstockrecordsfortheprevious12 monthsforeachof15keymedicines.Table7illustratesthefindingsonstockͲoutdurationin thepublicandFBHSfacilitiesandcentralwarehouses.

Table7:MedicinesstockͲoutdurationinhealthfacilities andcentralwarehouses Averagestockoutduration National Percentile Value National Standard (days)overpastyear Median 25th 75th Min Max Average Deviation Governmenthealthfacilities 46.0 32.3 65.8 4.8 169 55.8 35.4 FBHShealthfacilities 13.5 0.0 36.4 0 72 19.7 22.3 Governmentwarehouse 0.0 FBHSwarehouse 0.3 x ThemedianstockͲoutdurationofthebasketofmedicinesingovernmenthealthfacilities was46dayscomparedwith14daysinFBHSfacilities x ThecentralwarehouseshadvirtuallynostockͲoutsofthesemedicines

These findings indicate that there are interruptions in the public sector supply chain and comparativelylessintheFBHSsupplychain.Inlightofthefindingofthatcentralwarehouses had virtually no stockͲouts, stockͲouts in health facilities point to weaknesses in the distributionsystems.MedianstockͲoutdurationforgovernmentfacilities,hasincreasedfrom the25daysbaselinefigurein2003to46days. 4.2.5SeverityofMedicinesStockͲoutDuration Data on stockͲouts of the 15 basic medicines was further analyzed with respect to the severity of their duration in government and FBHS health facilities. Findings are shown in Figure6below.

24 Figure6:AveragestockͲoutdurationofmedicinesinhealthfacilities(rangeofdays)

Stock of Duration- Distribution of Health facilities

80% 72.2% 70%

60% s 50% 38.9% Access in GoK facilities 40% Access in Mission facilities 30% 25.0% % of Facilitie of % 19.4% 20% 13.9% 13.9% 10% 2.8% 0.0% 0% <30days 30-60days 60-90days >90days No. of stock out days - Range x Ofthepublichealthfacilitiesthathadexperiencedstockoutsofthesurveyedmedicines, 19.4%ofhadastockoutdurationoflessthan30days.Themajority(66.7%)hadstockͲ outsofmorethan30daysandofthese,14%weremorethan90days x OftheFBHSfacilitiesthatexperiencedstockoutsofthesurveyedmedicines,thesehad lastedlessthan30daysformost(72%)facilitiesandnonehadlastedmorethan90days. An effective medicines management system should ensure that essential medicines are in stockatalltimes.Thesefindingsindicatethatmedicinestockoutsofinpublicfacilitiesare sometimescritical,extendingbeyond30oreven90days.Comparatively,stockͲoutsinFBHS facilitiesarelesssevere,andthiscorrelateswiththelowerstockͲoutdurationinthissector. 4.2.6Adequacyofstockrecordsinpublichealthfacilitiesandregionalwarehouses Stockrecordsarecriticalforaneffectivemedicinesupplysystem.Comprehensive,accurate and up to date records contribute to proper management, estimation of needs and medicinesreͲordering.Todeterminetheadequacyofstockrecords,stockcardsforthe15 targetbasicmedicineswereexaminedtoascertainthoseforwhichthereweretransaction entries33covering the latest continuous period of at least 6 consecutive months in the previous 12 months. This indicator only assesses the existence of the records, without verificationofwhethertherecordsareaccurate.Adequacyofstockrecordswascalculated astheproportionofthesurveyedmedicineswithcompleterecords.

Table8:AdequacyofStockRecords Adequacyofrecords NationalMedian Governmenthealthfacilities 76.7 FBHShealthfacilities 83.3 Governmentwarehouse(KEMSA) 100 FBHSwarehouse(MEDS) 100

33Keyentriesconsideredwere:quantitiesreceived,quantitiesissuedandstockͲonͲhand

25 x The median proportion of adequate stock records was 77% in government health facilities,comparedwith83%inFBHShealthfacilities. x BothKEMSAandMEDShadadequatestockrecordsforallmedicinessurveyed x Adequacyofstockrecordshaddeclinedingovernmenthealthfacilitiescomparedtothe 2003baselinesurveywhenitwas93%. Findings indicate that FBHS health facilities had more adequate stock records than public healthfacilities.Further,therehasbeenadeclineintheadequacyofstockrecordsinpublic healthfacilitiessincethe2003baseline. 4.3PRICINGANDAFFORDABILITY Through the provisions of the KNDP 1994 and the KNPP, the government is committed to make Essential Medicines available and affordable to the population. Whereas progress is beingmadetowardsthisgoal,therearecircumstanceswherepatientsmayoftenhavetopay for the medicines that they need. Consequently, where medicine prices are high, people (especiallythepoor)mayhavetoforegotreatmentorincurdebtsinordertoaffordtheoutͲ ofͲpocket expenses for the lifeͲsaving medicines they need. Although the purchasing of medicinesrepresentsonlypartofthecostsassociatedwiththemanagementofanillness,it isclearthatthehighcostofmedicinescanhavecatastrophiceffectsonpoorpeople. 4.3.1RatioofmedianunitprocurementpricetoMSHinternationalreferenceprice The price paid for Essential Medicines by central procurement agencies, is a major determinant of the prices charged to patients for the medicines. Price efficiency in procurement can therefore contribute to enhanced access. To assess this, the median procurementpricesofthegovernmentandFBHScentralwarehouseswerecomputed,asa ratio of the MSH international reference prices for the corresponding medicines. Table 9 showstheMPRsforthe36MMePAlistmedicinessurveyed. Table9:MedianProcurementPriceRatios(comparedwithIRPs) forpublic&FBHSsectors

OriginatorbrandMedian Lowestpricegenerics Sector MPR(n=1foreachsector) MPR Min Max Government(n=21) 3.39 0.44 0.13 0.84 FBHS(n=32) 2.48 0.61 0.19 1.33 x Ofthe36 medicinesincludedin thesurvey,onlyoneoriginatorbrand and 21 generics werefoundinKEMSAwhilstoneoriginatorand32genericswerefoundinMEDS. x BasedonthemedianMPRs,KEMSAisprocuringgenericsat0.44timestheirinternational referenceprices(IRP)whilstMEDSisprocuringat0.61timestheirIRP. x Theoneoriginatorbrandfoundinthegovernmentwarehousewasprocuredat3.4times itsIRP,whereasthatfoundintheFBHSwarehousewasprocuredat2.5timestheIRP The findings indicate that the government and FBHS procurement agencies are almost exclusively procuring generic products and are obtaining priceͲefficiency in medicines procurement,withthegovernmentsectorobtainingcomparativelylowerprices.

26 4.3.2Medicinesprovidedfreeofcharge:public,FBHSandprivatefacilities InKenya,variouspublichealthanddiseasecontrolinitiatives34haveenabledtheprovisionof essentialmedicines‘freeofcharge’35ingovernmentfacilities,andinothersectorsforspecific programmes. The survey sought to determine the extent to which this policy was being implementedinthe3sectors(i.e.medicinesbeingissuedforfree).Dataforthe36MMePA listmedicines(Annex7)and96healthfacilities(32facilitiespersector)wascomputedfor caseswhereamedicinewasavailableinthefacilityandissuedforfreetopatients. Table10:Freeofchargemedicines:public,FBHSandprivatefacilities Overall Medianprevalenceof Sector Availability Issuedforfree Priced Public 67.2% 89.4% 10.6% FBHS 65.6% 15.5% 84.5% Private 81.3% 0% 100% x In public health facilities, a substantial proportion of available medicines (89.4%) were providedfreeofchargetopatients,comparedwith15.5%inFBHSfacilitiesandnonein privatepharmacies. Thesefindingsindicatethatthepricebarrierthatpeoplemayfacewhenaccessingmedicines is significantly lower in the public sector and that Government policies on issuance of medicinesforfreearelargelybeingimplemented.However,giventherelativelylow(67%) availabilityofthesurveyedmedicinesingovernmenthealthfacilities,thefullpotentialofthis sectortoimpactaccesscannotberealized.ThefindingsalsoindicatethattheFBHSsectoris alsoplayingarole,albeitlimited,inloweringthepricebarrierforessentialmedicines. 4.3.3RatioofmedianpatientpricestoMSHinternationalreferenceprice(IRP) Thesurveydocumentedpriceschargedtopatientsforthose36medicinesontheMMePAlist thatwereavailableineachsurveysite.Foreachmedicine,themedianpatientprice36was computedseparatelyforthepublic,FBHSandprivatefacilities.ToobtaintheMedianPrice Ratio(MPR),thesemedianpatientpriceswerethencomparedtothecorrespondingmedian priceforthemedicine,quotedintheMSHDrugPriceIndicatorGuide2008,andamedian MPRcomputed.Table11presentsthemedianMPRforthepublic,FBHSandprivatefacilities. Table11:Patientprices:ratioofmedianpricestoIRP:public,FBHS&privatesectors Sector MedianRatios No.ofMedicines Public 1.66 14 FBHS 2.6 32 Private 3.29 32

34Such initiatives include the reduction of user fees in July 2004.A standard fee of KES 10 or KES 20 for dispensaries & health centers respectively, replaced the costͲsharing fees previously charged for medicines. DiseasecontrolinitiativesincludetheprovisionoffreemedicinesforconditionsofpublicͲhealthpriority,e.g. malaria,TB,HIV/AIDSthroughGovernmentfinancingandfinancialsupportfromhealthdevelopmentpartners. 35Althoughthereisnochargeleviedforamedicinesupplied,astandardfeeischargedperpatient(seeabove) forregistrationwhichcoversanymedicinesprovided. 36FordetailsonthecalculationoftheMPR,seeDefinitionofTermsandConcepts,p17

27 x In the public sector, the prices that patients pay for medicines whencharged are 1.66 timestheinternationalreferenceprice(IRP).Thisratiowas2.6intheFBHSfacilitiesand 3.29inprivatesectorfacilities.

ThepublicsectorMPRwasonlycomputedforthe14medicinesforwhichamedianpricewas availableinthissector.Theother22medicineswereeithernotavailableinthefacilitieson thedayofthesurveyorwereissuedtopatientsforfree.Forthe14medicines,thefindings indicate that patient prices in the public sector are fairly affordable. However, since the methodologyonlycomputespricemedianswhere3ormorepricedatapointsareavailable anddoesnotincludeazeroprice(freemedicines)theratioof1.66isdistorted,andinreality ismuchlower.Furthermore,patientpricesinthepublicsectorareabout40%lowerthan thoseintheFBHSfacilities,andabout50%lowerthanthoseintheprivatesector. 4.3.4Ratioofmedianpatientpricestomedianprocurementprices Tocompareprocurementpriceswiththefinalpatientprices,ratioswerecomputedforthose medicineswheremediansforbothofthesepriceswereavailable.Table12illustratesMPRs forthepublicandFBHSsectors. Table12:Medianpatienttoprocurementpriceratios forpublicandFBHSsectors Sector MedianMPR No.ofmedicines Public 4.51 10 FBHS 4.42 30 x In the public sector, the prices patients pay for medicines are 4.5 times the median procurementprice.ThisratiowassimilarintheFBHSfacilities(4.42). These price differences represent various addͲon costs along the medicines supply chain. SincethepublicandFBHScentralprocurementagenciesareobtainingefficientprocurement prices well below IRPs, the fourͲfold increase in the final prices to patients represents a disconnect between the pricing structures at the procurement level and those in health facilities.Thisreflectsalackofpolicyguidanceinthemedicinessupplychain,whereprice efficiencyupstreamisnotsustainedforthepublicbenefit. 4.3.5Comparisonofpatientpricesinthepublicandprivatesectors To determine the significance of patient prices on access in the three sectors, ratios were computedforthosemedicineswheremediansforallsectorswereavailable.Ofthelistof36 medicines surveyed, all sector medians were available for only 14 medicines. The median ratiosbetweensectorsareillustratedinTable12below. Table13:MedianMPRsfor14medicinesfoundinpublic,FBHSandprivatesectors Comparison MedianMPR Private/Public 2.22 FBHS/Public 2.29 x Price variance between the public and the other two sectors were comparable, being 2.22and2.29fortheprivateandFBHSfacilitiesrespectively.

28 These findings further highlight that patients pay lower prices for medicines in the public sector.AlthoughtheFBHS/publicratioisslightlyhigherthantheprivate/FBHSratio,thismay notreflectoverallhigherpricesintheFBHSsectorascomparedtotheprivatesector,but rather,thesituationforonlythe14medicines. 4.3.6OutͲpatientmedicinescosts Onthedayofthesurvey,theamountthateachpatientpaidoutͲofͲpocketforallmedicines receivedwasrecorded.Theaveragemedicinescostwascalculatedasthemeanofthetotal amount recorded for all respondents in each sector. Table 14 summarises findings for the government,FBHSandprivatehealthfacilitiessurveyed. Table14:AverageOutͲPatientMedicinesCosts Averagemedicinescost National National Min Max (KES) Median Average Governmentfacilities 0 0 460 33 FBHSfacilities 153 0 851 206 Privatepharmacies 182 36 1363 233 KES=KenyaShillings1US$=KES81.27 x Patients interviewed in public health facilities had incurred virtually no outͲofͲpocket expenditureonmedicines. x The median average cost for medicines per visit to an FBHS health facility and private pharmacywasfoundtobeKES153andKES182respectively x Thelowestamountspentonmedicinesbyanyoftherespondentswasnilinbothpublic andFBHSfacilities;comparedtoKES36inprivatefacilities. x ThehighestamountspentonmedicinesbyanyoftherespondentswasKES460,KES851 andKES1,363ingovernment,FBHSandprivatefacilitiesrespectively. OutͲofͲpocket medicines expenditure is a barrier to access, especially for the poor. The findingsshowthatpatientsobtainingmedicinesfromthepublicsectorgenerallyfacelower ornofinancialbarrierscomparedwithothersectors. 4.3.7Affordabilityofstandardtreatmentregimens The affordability of treatment for certain common conditions at government, FBHS and private health facilities was estimated as the number of days wages37of the lowestͲpaid unskilledgovernmentworkerneededtopurchaseaprescribedstandardcourseoftreatment. Foracuteconditions,treatmentdurationwasdefinedasafullcourseoftherapy,whilefor chronicdiseases,theaffordabilityofa30dayssupplyofmedicineswasdetermined.Thedaily wage of the lowestͲpaid unskilled government worker used in the analysis was KES 249 (approxUS$3).

37SeeGlossary,p89

29 Affordabilityoftreatmentofadultandchildpneumonia Figure7:Affordabilityofadultandchildpneumoniatreatment(indays’wages)

Affordabilityofpneumoniatreatmentforadults&children (inminimumwageworkdays)

0.50 0.48 Median 0.4

PublicHealthPharmacy National 0.20 0.20 PrivatePharmacy 0.2 MissionFacilities

0.0 0.0 0.0 Affordability of pneumonia Affordability of pneumonia treatment for adults treatment for children

x The median affordability of the standard treatment for moderate pneumonia in adults and children was nil days wages in public facilities (i.e. medicines were provided free whentheywereavailable) x Theaffordabilityofpneumoniatreatmentinadultsinprivatemedicineoutletswasvery similartothatintheFBHSsectorat0.5and0.48dayswagesrespectively. x Theaffordabilityofpneumoniatreatmentinchildrenwasfoundtobeequivalentto0.2 dayswagesinboththeFBHShealthfacilitiesandprivatepharmacies. Inallsectors,theamountpaidforpneumoniatreatmentwasrelativelyaffordable,beingless thanoneday’swage. Affordabilityoftreatmentofdiabetesinadultsandasthmainchildren Figure8:Affordabilityoftreatments:Adultdiabetes,childasthma

Affordabilityofdiabetestreatmentforadultsandasthmainchildren (inminimumwageworkdays)

6 5.4

Median 4.0 PublicHealthPharmacy 4 PrivatePharmacy 2.4 MissionFacilities National 2 1.2 1.4

0.0 0 DiabetesinadultsAsthmainchildren

30 x ThemedianaffordabilityofinsulintreatmentforadultdiabetesingovernmentandFBHS healthfacilitiesandprivatepharmacyoutletswas1.2,4.0and5.4dayswagesrespectively x Themedianaffordabilityofasthmatreatmentforachild(withbeclomethasoneinhaler) in government health facilities was nil days wages (medicines provided free when available)whereasthesametreatmentinFBHSfacilitiesandprivatepharmacyoutlets1.4 and2.4dayswagesrespectively Thesefindingsindicatethatstandardtreatmentsforadultdiabetesandasthmainchildren were most affordable in public health facilities and were more affordable in FBHS health facilities than private pharmacies. The lowest paid government worker would spend considerablymorethan1dayswagetopurchaseanyofthesestandardtreatmentsinanyof the sectors, except for treatment of asthma in children which was free at public health facilities.Thisrepresentsalargeinvestmentforjustonemedicine/treatmentforoneperson. 4.3.8Affordabilityofselectedstandardtreatments:public,FBHSandprivatesectors Tomeasureaffordability,thetreatmentsofchoice(basedoncurrentSTGs)wereidentified, and the number of units needed to complete the treatment computed. The unit price chargedtopatientswasobtained,plusanyapplicablecharges(dispensingfees,syringes,etc). Ifaflatfeewaschargedforamedicine,thiswasrecordedasthetreatmentprice.Foreach treatment,affordability(inday’swages)wassubsequentlycomputed.Table15illustratesthe medianaffordabilityofthestandardtreatmentsinthepublic,privateandFBHSfacilities. Table15:Affordabilityofselectedstandardtreatments inpublic,FBHSandprivatesectors Medianaffordabilityof Diseaseconditionand‘standard’treatment treatmentbysector (indayswages) Drugname,strength, Treatment Condition Public Private FBHS dosageform schedule Beclomethasone Asthma 1inhalerof200doses 0.80 3.01 1.81 50mcg/doseinhaler Diabetes Glibenclamide5mgtab 1tabtwicedailyfor30days=60 0.23 1.02 0.60 Depression Amitriptyline25mgtab 1tabthricedailyfor30days=90 0.30 0.36 0.36 Ciprofloxacin500mgtab 1tabtwicedailyfor7days=14 0.28 0.62 0.39 Amoxicillin500mgcap 1capthricedailyfor7days=21 0.34 0.51 0.51 AdultARI Ceftriaxoneinjection 1vial 1.45 1.93 3.61 1g/vial Cotrimoxazole ChildARI 5mltwicedailyfor7days=70ml 0.14 0.17 0.13 240mg/5mlsusp Arthritis Diclofenac50mgtab 1tabtwicedailyfor30days=60 0.34 0.73 0.48 ARI=acuterespiratoryinfection x Standardtreatmentsformostconditionswouldcostonedayswageorlessinallsectors. The exceptions were beclomethasone inhaler, ceftriaxone injection and glibenclamide tablets. x Onlyceftriaxoneinjectionwouldcostmorethanaday’swageinallsectors,being1.45, 3.61and1.93daysinthepublic,FBHSandprivatesectorrespectively.

31 These findings indicate that individual treatments for most conditions are relatively affordableinallthesectors,butmostaffordableinthepublicsector. 4.4GEOGRAPHICALACCESSIBILITY Thetimetakenbypatientstoreachahealthfacilityisasignificantdeterminantofaccessto medicines. The cost of travelling to the facility (including costs for accompanying persons where the patient cannot travel alone) is an additional component of this determinant. Throughexitinterviewsofasampleof90patientswhohadobtainedtreatmentinthepublic, FBHSorprivatefacilities(30patientspersector),thesurveymeasuredthetimetakenand transportcostsincurredbypatientstoreachthathealthfacility.Figure9belowillustratesthe proportionofpatientswhotookmorethanonehourtoreachthehealthfacility;andTable 16belowshowsthemediantravelcostsforpatientstothatfacility. Figure9:Percentageofpatientstaking>1hourtotraveltoadispensingfacility

Access:GeographicalAccessibility 20% 19.1% Median

Public Health Pharmacy National 10% Private Pharmacy 10.0% Mission Facilities 6.7%

0% %patientstakingmorethanonehourtotravel tothefacility x Themedian%ofpatientstakingoveranhourtotraveltoadispensingfacilitywas19%, 10%and6.7%forthepublic,FBHSandprivatefacilitiesrespectively. Table16:GeographicalAccessͲTransportCosts Averagetransportationcosttohealthfacility Facilitytype (Nationalmedian) KES Dayswages Public 9.7 0.04 FBHS 26.0 0.10 Private 33.9 0.13 x TheaveragetravelcosttoFBHShealthfacilitiesandprivatepharmacieswasabout0.1 dayswagewhichwasabout3timesthattopublichealthfacilities.

Thesefindingsshowthatmostpatientsaccessingtreatmentinallsectorstakeunderanhour toreachthehealthfacility.However,alargerproportionofthoseaccessingtreatmentinthe publicsectortakeoveranhour,comparedwithothersectors.Sincepatientsmaytravelto health facilities on foot or by vehicle, the time taken is not necessarily a reflection of the

32 distance to the facility from the patients’ homes. Therefore, the cost of travelling to the facilitygivesfurtherinsightintogeographicalaccessibility. Thefindingsindicatethatpatientsaccessingtreatmentinpublicfacilitiesspendlessontravel. Theaveragetravelcosttoallfacilitieswasabout0.1dayswages,whichmaybeunaffordable to the poor in Kenya. When examined against the relatively higher proportion of patients who take over an hour to reach these facilities and the relatively higher transport costs incurredtoFBHSandprivatefacilities,itmaybeinferredthatmorepatientstraveltopublic facilities on foot (hence taking longer and spending less) compared with FBHS or private facilities (where patients take a shorter time, but spend more).Therefore, poverty is an importantfactoraffectinggeographicalaccessandmayexplainthesefindings. 4.5MEDICINESQUALITYͲRELATEDFACTORS Thesurveyexaminedtwofactorsthatcriticallyaffectthequalityofmedicines,i.e.medicines expiryandconditionsforconservationandhandlingathealthfacilitiesandwarehouses. 4.5.1Presenceofexpiredmedicines Theexistenceofexpiredmedicinesondispensingshelves,indicatesthepossibilityofpatients receiving them. To determine if such medicines were being distributed or sold, the expiry datesoftheavailablestock(genericandbrandedforms)ofthe15basictargetmedicineswas checkedbydirectexaminationandanypackofexpiredmedicinenoted. If expired medicines were listed and kept in a designated location in the store to be destroyed, this was not considered as an expiry. Table 17 highlights the findings in the government,FBHSandprivatefacilities;andthecentralwarehouses. Table17:PercentofExpiredMedicines

Average%expiredmedicines(byitem)

Governmenthealthfacilities 2.3 FBHShealthfacilities 2.1 Privatemedicinesoutlets 1.9 Governmentwarehouse 0.0 FBHSwarehouse(MEDS) 0.0 x Incidences of expired medicines on dispensing shelves were noted for 2.3% of the medicinessurveyedingovernmenthealthfacilities,comparedwith2.1%inFBHSfacilities and1.9%inprivateretailoutlets x NoexpiredmedicineswerefoundontheshelvesinKEMSAandMEDSwarehouses ThelowincidenceofexpiredmedicinesinpublicandFBHSfacilities,privatepharmaciesand central warehouses indicates that adequate measures are in place in all sectors to guard againstexpiryofmedicines.

33 4.5.2Adequacyofstorageconditionsinhealthfacilitiesandthecentralwarehouses To determine the status of conservation and handling of medicines, a check list of the minimum criteria for adequacy of medicines handling and conservation conditions was developed prior to the survey, and is attached as Survey Form 5 (see Appendix 3). The proportionofcriteriametwasnotedseparatelyforthemedicinesstoreroomanddispensing areaofeachfacilitysurveyed,andanaveragewascalculatedforallfacilitiesineachsector. Figure 10 illustrates the average proportion of adequate conservation and handling conditionsformedicinesinthegovernment,FBHSandprivatefacilities.

Figure10:Adequacyofmedicinesstorageconditions

Adequacyofstorageconditions(%)

100 100.0

80.0 80 77.3 75.0 72.7 GoKFacilities 60 60.0 61.8 MissionFacilities 50.0 Privatemedicineoutlets 40 KEMSA MEDS 20

0 Storeroom Dispensingarea x The median adequacy of conservation and handling conditions for medicines was only 60%inthestoreroomsand62%inthedispensingareasofgovernmenthealthfacilities; comparedto75%and73%respectivelyintheFBHShealthfacilities. x The central warehouse for the government sector (i.e. KEMSA) met only 50% of the minimum criteria for adequacy of medicines handling and conservation conditions, comparedwiththecentralFBHSwarehouse(MEDS)whichmetallthecriteria. x ExceptforthecentralFBHSwarehouse(MEDS)whichmetallthecriteria,theadequacyof medicines handling and conservation conditions ranged from 50% in the government warehouseto80%inprivatemedicineoutlets. x There were no significant variations in the storage conditions of medicine storerooms comparedtothoseofdispensingareasinallthesectors. These findings indicate that storage conditions in public health facilities are critically inadequate,puttingatriskthequalityofmedicinesdistributedthroughthissector.Compared with 2003, storagefacilitiesformedicines havedeterioratedorremainedinadequateboth centrallyandinhealthfacilitiesinthepublicsector.ItisnoteworthythatthecentralFBHS warehousemetallthecriteria,suggestingthatsystemsareinplaceandresourcesdeployed tobetterensureproperconservationandhandlingofmedicinesinthiswarehouse.

34 4.6RATIONALUSEOFMEDICINES

Rationalmedicinesuseisessentialifwasteandhazardtopatientsistobeminimisedandthe potential for desired therapeutic outcomes maximised. Appropriate medicines prescribing and dispensing following wellͲestablished good practices for each activity contribute to ensuringthatpatientsreceivethecorrectmedicinesinthecorrectdoseregimenstogether with all necessary relevant and practical information on correct use and storage of each medicine.Prescribinganddispensingindicatorscangaugehealthprofessionals’practicesand roleinpromotingappropriatemedicinesuse. 4.6.1PrescribingIndicators Data on prescribing was collected through a retrospective review of outpatient treatment records in each health facility. All available treatment records for the previous 12 months wereobtainedbeforebeginningthesamplingandasampleof30prescriptionsselectedin eachfacility.Thissamplewasusedtodeterminethefiveprescribingindicatorsasdescribed insection4.6.1.Table18andFig11illustratethefindingsonprescribingofmedicinesinthe publicandFBHSfacilitiesandeachindicatorisdiscussedseparatelyinthefollowingsections. Table18:GeneralIndicatorsforRationalUseofMedicines(bysector) Reference NationalMedian Indicator values Public FBHS Averageno.medicinesperprescription* <2 3.0 3.0 %patientsprescribedanantibiotic <30 76.7 68.4 %patientsprescribedaninjection <20 13.3 26.8 %prescribedmedicinesontheEML 100 93.4 79.2 %medicinesprescribedbygenericname(INN) 100 31.8 34.7 %availabilityofstandardtreatmentguidelines 100 41.7 25.0 %availabilityofessentialmedicineslist 100 38.9 47.2 *Thisindicatorwasmeasuredthroughpatientexitinterviewsandfacilitysampledprescriptions, andthefindingswerethesame Figure11:Prescribingofantibiotics,injections,medicinesontheEMLandbyINN

RationalMedicinesUse:PrescribingPractices

100 % 93.4 80 76.7 79.2

National 68.4 60

40 31.8 34.7 20 26.8 13.3 0 %patients %patients %prescribed %medicines prescribed prescribed medicinesonthe prescribedby antibiotics injections essentialmedicines genericname(INN) list GoKFacility MissionFacility

35 a)Averagenumberofmedicinesperprescription PolypharmacyͲtheunnecessaryprescribingofalargenumberofmedicinesforanysingle conditionͲcanbeusedasaproxymeasureforirrationaluseofmedicines.Thenumberof medicinesprescribedwasestablishedfromthesampleof30retrospectiveoutpatientrecords ineachfacility,asdescribedin(seesection3.1.5,p17). x Themediannumberofmedicinesprescribedwasfoundtobe2.8and2.9fortheFBHS and government facilities respectively meaning that the average patient exiting the facilitieshadreceived2to3medicines. x Outpatient records showed that in the past year, patients had received a median of 3 medicinesinboththeFBHSandgovernmenthealthsectors. ThefindingshowsimilaritiesinprescribingpracticebetweenpublicandFBHSfacilities;and polyͲpharmacyisnotamajorprobleminthesefacilities. b)Percentageofpatientsprescribedanantibiotic OverͲprescribingofantibioticsisacommontypeofinappropriatemedicineuse.Thelevelof antibiotic prescribing was determined through a sample of 30 retrospective outpatient encountersinthe36healthfacilitiesineachsector(seesection3.1.4,p17).Theproportionof encounterswhereatleastoneantibiotic38hadbeenprescribedwasdetermined. x The median % of patients prescribed one or more antibiotics in government health facilitieswasfoundtobe76.7%comparedwith68.4%ofpatientsintheFBHSsector. x In 84.2% of government health facilities and in 83% of FBHS facilities, over 75% of patientswereprescribedoneormoreantibiotics. ThisfindingsuggeststhatantibioticprescribingishighinbothgovernmentandFBHShealth facilities,beinghigherintheformer.OverͲprescribingofantibioticshasmanynegativeeffects includingmostimportantlyencouragingthedevelopmentofantimicrobialresistance. c)Percentageofpatientsprescribedaninjection OverͲprescribingofinjectionsforoutͲpatientsisacommontypeofinappropriatemedicine use.Injectableformulationsarerelativelyexpensiveandrequireadditionalexpensessuchas needles,syringesandotherassociatedmedicineadministrationcosts.Inadditions,injections contribute to increased risks of infection transmission (e.g. Hepatitis B and HIV) through contaminatedneedles,injectionabscessesandnervedamage.Theprevalenceofoutpatient injection use was determined through the same sample of 30 retrospective outpatient encountersineachhealthfacility(seesection3.1.4,p17).Theencounterswhereaninjection hasbeenprescribedweredetermined39. x The median % of patients prescribed one or more injections in government health facilitieswasfoundtobe13%comparedwith27%intheFBHSsector.

38Sinceantimicrobialagentsarenotalwaysclassifiedinthesameway,definitionofthemedicines consideredtobeantibioticswasagreeduponbytheSurveyAdvisoryGroupandthedatacollectors duringplanningforthesurvey. 39Forthepurposesofthisindicator,immunizationsandinjectablecontraceptiveswerenotcounted.

36 ThisfindingindicatesahighprevalenceofinjectionuseingovernmentandFBHSfacilities, withtheprevalenceinFBHSfacilitiesbeingtwiceashighasthatingovernmentfacilities. d)PercentageofprescribedmedicinesonthenationalEML TheEssentialMedicinesConceptisacoreprincipleofthenationalpharmaceuticalpolicy,and servestoguidehealthinvestmentstowardsthosemedicinesofpriorityimportanceforpublic health,thuspromotingmedicinesaccess.Inorderforthisgoaltobeattained,thenational EssentialMedicinesList(EML)shouldbethebasisforallpublicmedicinesprocurementand prescribing.Tomeasurethedegreetowhichprescribingpracticeconformstothenational EML,thesamesampleof30retrospectiveoutpatientencountersineachhealthfacility(see section3.1.4,p17)wasused,andtheproportionofprescribedmedicinesthatwerelistedin thecurrentEMLwasdetermined40. x The median % of medicines prescribed that were on the public sector supply list was foundtobe93%and79%inthegovernmentandFBHShealthfacilitiesrespectively. The finding indicates a high degree of conformance with the public sector supply list in government health facilities, but less so in FBHS facilities. Given that an updated national EMLwasnotpublishedatthetime,thelowerlevelofconformanceintheFBHSfacilitiesis notsurprising,sincetheFBHSsupplysystemwouldnotnecessarilyberestrictedtothepublic sectorsupplylist.Furthermore,thisfindingunderscorestheimportanceofhavinganupdated national EML to serve as a reference document for all sectors, and to facilitate objective monitoringofmedicinesuse. e)Percentageofmedicinesprescribedbygenericname(INN) PrescribingbyitsInternationalNonͲproprietaryName(INN)enablesthepatienttoobtainthe most costͲeffective medicine available, without reference to its brand name or specific manufacturer.Thedegreetowhichprescribingpracticeconformstotheprinciplesofgeneric prescribing was measured through the same sample of 30 retrospective outpatient encountersineachhealthfacility(seesection3.1.4,p17). Ofthetotalmedicinesprescribed, theproportionprescribedbytheirgeneric(INN)namewasdetermined. x Themediannumberofmedicinesprescribedbygenericnamewas31.8%ingovernment healthfacilitiesand34.7%inFBHSfacilities. ThesefindingsindicatethatprescribingbygenericnameisextremelylowinpublicandFBHS facilities. If medicines are prescribed by trade name and not subsequently substituted by generic equivalents at the time of dispensing, patients may pay unnecessarily more, and affordability(andconsequentlyaccessibility)willbeadverselyaffected.Prescribingbytrade namecanalsomeanthatprescribersdonotbecomeadequatelyfamiliarwith,andtherefore donotrelatewelltoofficialmedicinesandtherapeuticsdocumentssuchastheEMLandSCG, inwhichmedicinesarealwaysstatedbygenericname.

40For the purposes of this indicator, the public sector formulary list was used as proxy for this indicator,becausethenationalEMLwasunderrevisionatthetimeofthesurvey.

37 f)PercentageavailabilityofSTGandEML A national Essential Medicines List (EML) and Standard Treatment Guidelines (STG) Ͳ or clinicalguidelinesͲarekeydocumentsforensuringthatmedicinesareprocured,prescribed anddispensedrationallyandinlinewithpublichealthpriorities.Decentralizedhealthunits, e.g. district level health services or individual health facilities may develop further more specificformularylistsandmanuals,basedontheEML.Theseservetoguidemedicinesuse withinthecontextofthecommunitywherethehealthservicesareprovided. The survey sought to establish the availability of these documents in the public and FBHS facilities. x ThenationalEML,facilityspecificformularyand/ormodelWHOMLwerefoundin41.7% ofthegovernmenthealthfacilities. x StandardTreatmentGuidelineswerefoundin38.9%ofthegovernmenthealthfacilities x ThenationalEML,facilityspecificformularyand/ormodelWHOEMLwerefoundin25% ofFBHShealthfacilitieswhilstSTGswerefoundin47.2%ofthesefacilities. These results indicate that these key documents for promoting RUM are not available to mosthealthcareprofessionals. g)PercentoftracercasestreatedwiththemedicinesrecommendedinnationalSTGs Thenationalguidelinesformanagementofdiarrhoeainchildrenbelow5yearsrecommend oralrehydrationsalts(ORS).Antibioticsand/orantiprotozoalsshouldonlybeprescribedfor dysentery, and suspected cholera or amoebiasis. In the treatment of mild/moderate pneumoniainchildrenunder5years,therecommendedfirstlineantibioticiscotrimoxazole oramoxicillin(forpatientspreviouslytreatedwithcotrimoxazole).Theuseofmorethanone antibiotic is only recommended in cases of severe pneumonia, where two injectable antibiotics may be administered. The recommended treatment for URTI is symptomatic treatment of cough with simple linctus or a home remedy, adequate fluid intake +/Ͳ an antipyreticiffeverispresentͲbutNOantibiotic.ArtemetherͲlumefanthrineisthemedicine of choice in the management of uncomplicated malaria, and quinine tablets are the recommendedsecondlinetreatment. Treatmentofdiarrhoeainchildrenunder5years Amajorassumptionwasmadethatanydiagnosisindicatedasdiarrhoeawasequivalentto nonͲbacterialdiarrhoea.Thisisbecausethetendencyistodiagnosebacterialdiarrhoeaas thecausativeagent,e.g.typhoid,amoebiasis,cholera,etc. x Themedian%useofORSwas80%inpublicfacilitiesandlower(60%)inFBHSfacilities. x Themedian%useofoneormoreantibiotics washigh,at70%and 50%inpublicand FBHSfacilitiesrespectively. x Themedian%useofanantiͲdiarrhoealand/orantispasmodicagentinchildrenunderͲ5 withdiarrheawas0%inthepublicfacilitiesand5%inFBHSfacilities.

38 Table19:Adherenceofprescriberstorecommendedtreatmentguidelines Condition Indicator Public FBHS Median Ave Median Ave NonͲbacterialdiarrhoea Total#ofcases 10.0 9.4 10.0 8.9 inchildren<5years %ORS 80.0 71.5 60.0 52.5 %Antibiotics 70.0 61.9 50.0 44.7 %Antidiarrhoeal 0.0 13.9 5.0 16.4 and/orAntispasmodic Mild/mod.pneumoniain Total#ofcases 10.0 9.6 10.0 9.2 children<5years st %receivinganysingle1 95.0 80.3 61.3 63.7 lineantibiotic %receiving>1antibiotic 20.0 30.3 33.8 37.3 NonͲpneumoniaARIin Total#ofcases 10.0 9.7 10.0 9.2 patientsofallages(URTI) %Antibiotics 100.0 87.9 90.0 90.0 Treatmentofmild/moderatepneumonia(outpatient)inchildrenunder5years x Themedian%ofpatientsreceivinganysingle1stlineantibioticwasfoundtobe95%and 61%inthegovernmentandFBHSfacilitiesrespectively x Themedian%receivingmorethanoneantibioticwasfoundtobe20%and34%inthe governmentandFBHSfacilitiesrespectively.Thisisclearlyexcessive.

TreatmentofnonͲpneumonicacute(upper)respiratorytractinfection: x Themedian%useofantibioticswasfoundtobe100%and90%ingovernmentandFBHS facilitiesrespectively ThefindingsonadherencetoSTGsforselectedconditionsaremixed.Whereasthereissome conformancetorecommendedfirstlinetreatments,e.g.ORSfornonͲbacterialdiarrheaanda first line antibiotic for mildͲmoderate pneumonia, there was overall high prescribing of antibioticswheretheyarenotindicated. 4.6.2DispensingIndicators Adequatelabelingofmedicinescontributestotheirappropriateuse.Ifmedicinesaretobe used properly, they should be labeled appropriately by the person dispensing them. An effective dispensing encounter should result in a patient having adequate knowledge that would enable them take the dispensed medicines correctly. The adequacy of medicines labeling and patients’ knowledge of how to take their medicines, were used as proxies to assessqualityofdispensingpractice.Dataonthe%ofprescriptionͲonlymedicinessupplied withoutaprescriptionwasonlyobtainedfromprivatepharmacies. Data was obtained from 30 prospective outpatient encounters at each health facility surveyed (see sec 3.1.5, p13). The interviewees were sampled from patients leaving the dispensingareaorfacilityaftertheyhadbeentreatedandreceivedmedicines.Table20and Figure 12 illustrate the findings on adequacy of labeling and patients’ knowledge on dispensedmedicines.

39 Table20:DispensingIndicators NationalMedian(bysector) Indicator Public FBHS Private %Medicinesadequatelylabeled 5 21 40 %Patientswhoknowhowtotaketheirmedicines 77 87 93.3 %prescriptionmedicinesboughtwithoutaprescription 60.8 Figure12:Adequacyoflabelingandpatientknowledge

RationalMedicinesUse: Labelling&PatientKnowledge 100 93.33 86.87

80 76.64

40.00 40

20.69 20

5.34

0 %medicinesadequatelylabelled %patientsthatKnowhowtotake medicines

GoKFacility MissionFacility PrivatePharmacy a)Percentageofmedicinesadequatelylabelled Anadequatelabelshouldincludethepatient’sname,themedicinenameandstrengthand written instructions on how much is to be taken and the frequency of administration. For eachmedicinedispensedtothepatient,thelabelwasexaminedtocheckifitconformstoall requirements for adequate labeling. A label was considered as adequate only if all requirementsweremet. x The median % medicines adequately labeled in government facilities was found to be 5.3%,i.e.onlyabout1inevery20labelswerefoundtobeadequate x Themedian%medicinesadequatelylabeledinprivatepharmaciesandFBHSfacilitieswas 21%and40%respectively. Thesefindingsindicatethatlabelingofmedicineswasgrosslyinadequateinallsectorsand criticallylowingovernmenthealthfacilities.

40 b)Percentageofpatientswhoknowhowtotakedispensedmedicines Adequate knowledge includes knowing the complete and correct dose regime for each medicine, ie. appropriate dosage (how much) the frequency (how often) and the duration (howlong). The same patients sampled for adequacy of medicines labeling were also interviewed to assessthisknowledge.Attheexitinterview,eachpatientwasaskedtoexplainbrieflyhow the medicine dispensed to them should be taken. A patient was considered as having adequateknowledgeonlyif,foreachdispensedmedicine,thepatientrecalledthecomplete and correct dose regime. The median percentage of those with adequate knowledge was calculatedseparatelyforpatientsinterviewedingovernmentandFBHSfacilities,andprivate pharmacies. x For patients who obtained their medicines in government health facilities, 77% had adequateknowledgeofhowtotakeofthemedicinesdispensed;comparedto87%and 93% of those obtaining medicines from FBHS facilities and private pharmacies respectively. Interestingly, despite the inadequacy of medicines labeling in all sectors, the majority of patients had adequate knowledge of how to take all the medicines dispensed. This could indicatesimplythatpatientshadreceivedadequatecounselingfromtheprescriberand/or dispenseronhowtotaketheirmedicinesandwereabletoeasilyrecallthisrecentlyreceived information.Incomparing theadequacyoflabelingand patients’ knowledgeondispensed medicinesacrosssectors,itisnoteworthythatprivatepharmacieshadthehighestscoresand governmentfacilitieshadthelowestscores.Thiswouldimplythatthelevelofprofessional practiceͲatleastasitappliestolabelingofdispensedmedicinesandcounselingofpatientsͲ ishigherintheprivatesectorthantheother(andinparticulargovernment)sectors. c)Percentage of prescription only medicines bought withouta prescription in the privatesector The existence of a prescription (and therefore a medical encounter) as the source of (prescriptionͲ)medicineseekingbehaviorshouldbethebasisforallsuchmedicinedispensing as a way to promote rational use of these medicines. Data was therefore collected from private pharmacies to determine if consumers are purchasing and dispensers are selling prescriptionmedicineswithoutprescription.

41 Figure13:Percentageofprescriptionmedicinesboughtwithoutaprescription

RationalUseofMedicines:%prescriptionmedicinesboughtwithout prescriptionоdistributionofpharmacies

36.7% 40% Facilities 30% of 23.3% % 20.0% 20.0% 20%

10%

0% <25% 25Ͳ50% 50Ͳ75% >75% %rangeofprescriptionmedicinesboughtwithoutprescription Theabovefigureshows theproportionofprivatepharmacieswhichsuppliedprescriptionͲ onlymedicineswithoutaprescriptioninfourrangesfortheproportionofthesemedicines suppliedinthisway. x Themedian%ofprescriptionmedicinesboughtwithoutaprescriptionwas61% x Over 75% of prescription medicines were bought without a prescription in 37% of the privatepharmacies These findings indicate that in the private sector there is widespread dispensing of prescriptionͲonly medicines without a prescription. This suggests a lack of enforcement of legalrequirementsforprescribinganddispensingofmedicines. 4.7HEALTHPROFESSIONALSPROFILES Appropriately trained health personnel contribute to rational use of medicines, through correct diagnosis, prescribing and dispensing in accordance with established treatment guidelines. The survey assessed the profiles of the personnel dispensing and prescribing medicinesinthehealthfacilities,andthefindingswereassessedagainstthecorresponding legalrequirements41. 4.7.1Dispenserprofile The law in Kenya (the Pharmacy and Poisons Act Ͳ Chapter 244, including subsequent amendments) recognizes the registered pharmacist and the enrolled pharmaceutical technologistastheonlytwocadresofhealthpersonnelqualifiedtodispensemedicines,and vests the authority to enforce these requirements with the Pharmacy and Poisons Board (PPB).Thesurveysoughttoestablishtheextenttowhichtheseauthorizedpersonnelwerein

41TheKenyaPharmacyandPoisonsAct(Cap44)section29allowssaleofprescriptionͲonlymedicines bypharmacistsagainstprescriptionsfromdulyqualifiedmedical,dentalandveterinaryprescriptions

42 factdispensingmedicinestooutͲpatientsonthedayofthevisittoeachfacility,andwhether otherhealthfacilitypersonnelwereinvolvedinthedispensingofmedicines. Table21:Dispenserprofileandcompliancewiththelaw %ofFacilitiesperSector Professionalsdispensingattimeofvisit Public FBHS Private Pharmacist 19.4 5.6 33.3 PharmaceuticalTechnologist 27.8 27.8 61.1 Nurse 27.8 47.2 11.1 Pharmacyaide/Healthassistant 11.1 30.6 44.4 Pharmacistintern 25.0 2.8 0.0 Untrainedstaff 41.7 25.0 13.9 Facilitiescomplyingwiththelaw(i.e.presenceof 38.2 30.6 80.6 aPharmacistorPharmaceuticalTechnologist)42 x A pharmacist was found in only 19.4% and 5.6% of public and FBHS health facilities respectively,andapharmaceuticaltechnologistin27.8%ofbothpublicandFBHSfacilities. x Pharmacy interns were almost exclusively found in the public sector, in 25% of these facilities. x Of the private pharmacies, 33.3% and 61.1% had pharmacists and pharmaceutical technologistsrespectively.Overall80.6%oftheprivatedispensingoutletscompliedwith thelawondispensingbylegallyqualifiedpersonnel,afactorthatmaybeattributedto thefactthatonlyregistereddrugoutletswereincludedinthesample. x Pharmacyaides/HealthassistantswerefoundmorefrequentlyintheFBHSfacilities(31%) andprivatepharmacies(44%),andlesssointhepublicsector(11%). x Untrainedstaffweremostfrequentdispenserfoundinthepublicfacilities(42%). The findings suggest that few public and FBHS facilities adhere to the law concerning dispensing by qualified personnel. This is an indication of less stringent regulatory enforcementinthesesectorscomparedwiththeprivatesector.Furthermore,dispensingof medicineshaslargelybeenlefttofacilitystaffthatarenotrecognizedwithinexistinglegal andpolicyframeworks.Thisunderscoresthecriticallackoftrainedpharmaceuticalpersonnel in public and FBHS facilities, which inevitably has a serious negative impact on patients’ safety and the quality of pharmaceutical services across the board. The minimum requirements for pharmaceutical personnel are defined in the health sector norms and standards43.Theseshouldbeappliedandappropriatelyreviewedtoaddressthisshortcoming.

42Totals do not add up to 100 because in some facilities more than one staff member was found dispensingmedicines 43NormsandStandardsforHealthServiceDelivery,MinistryofHealth,Kenya,June2006

43 Figure14:DispenserProfileandFacilitiesCompliancewithNationalLaws

DispenserProfileandCompliancewiththeLaw

100% Facilities of 80.6% % 80%

61.1% 60%

47.2% 44.4% 41.7% 38.2% 40% 33.3% 30.6% 30.6% 27.8% 27.8% 27.8% 25.0% 25.0% 19.4% 20% 13.9% 11.1% 11.1%

2.8% 2.8% 0.0% 0% Facilitiesthat Pharmacist Nurse Pharmaceutical Pharmacy Pharmacist Untrainedstaff complywith dispensing dispensing Technologist assistant intern dispensing thelaw dispensing dispensing GoKHealthFacility PrivatePharmacy MissionHealthFacilities 4.7.2Prescriberprofile Dependingonthenormsandstandardsapplicabletoeachlevelofhealthservicedeliveryand the availability of the required qualified personnel, different health cadres may be found prescribing medicines in health facilities. The survey sought to determine the profiles of personnelprescribingmedicinestooutͲpatients.Theseprescriberprofilesaresummarisedin Table22below. Table22:PrescriberProfile Prescribingat Mostseniorpresent Prescriber GOK FBHS GOK FBHS Doctor 16.7% 27.8% 27.8% 30.6% Nurse 41.7% 38.9% 38.9% 30.6% ClinicalOfficer 52.8% 61.1% 30.6% 38.9% Otherhealthworker 2.8% 0.0% 2.8% 0.0% Untrainedstaff 13.9% 5.6% n/a n/a TOTAL 100% 100% Note:Figuresroundedtonearestdecimalplace

44 Figure15:PrescriberProfile

PrescriberProfile:GoKandMissionfacilities

National% GoKFacilities MissionFacilities

70% 61.1% 60% 52.8% 50% 41.7% 38.9% 40% 27.8% 30% 16.7% 20% 13.9% 5.6% 10% 2.8% 0.0% 0% Doctor Nurse Trained Health worker Clinical Officer Untrained Health worker Prescribertype x ThemostfrequentprescriberwasaclinicalofficerͲfoundin52.8%ofthegovernment facilitiesand61%ofFBHSfacilitiesrespectively x Next was a nurse Ͳ found in 41.7% of the government facilities and 38.9% of FBHS facilitiesrespectively x The most senior prescriber was found to be a medical doctorͲ present in 28% of governmenthealthfacilitiesthoughfoundactuallyprescribinginonly17%ofthesample facilities.Oftheseseniorprescribers,69%hadparticipatedinrationaluseofmedicines traininginthepreviousyear x InFBHSfacilitiesthemostseniorprescriberwasfoundtobeamedicaldoctorͲpresentin 31% of facilities surveyed and found prescribing in 28% of these. Of these senior prescribers,75%hadparticipatedinRUMtraininginthepreviousyear x Untrained staffs were found prescribing in 13.9% of public facilities,and 5.6% of FBHS facilities The most frequent prescriber was the clinical officer, followed by the nurse. The medical doctorwaspresentinlessthanonethirdofgovernmentandFBHSfacilities,andwasactually found dispensing in even fewer of these facilities. Untrained personnel were sometimes found dispensing in government and FBHS facilities, and more frequently in government facilities. This finding underscores the shortage of properly trained and duly qualified prescribers and frequently Ͳ particularly at lower level facilities Ͳ prescribing is left in the handsofunderͲqualified,oreveninsomecasesunqualifiedstaff.Thisinevitablyhasaserious detrimental effect on the quality of diagnostic and prescribing practices with potential seriousconsequencesforpatientsafetyandtherapeuticoutcomes.

45 5.SUMMARYOFRESULTS

AvailabilityofEssentialMedicines a) Themajorityofbasicmedicinestotreatcommonconditionsatprimarycarelevelwere availableinallsectorsduringthissurveyperiod.However,abroaderscopeofessential medicineswaslessavailableinfacilitiesacrossallsectors. o Ofthebasic15medicines,87%wereavailableingovernmentfacilities,93%inFBHS facilities,100%inKEMSA,87%inMEDSand93%inprivatepharmacies. o Forabroaderlistof36essentialmedicines,67%wereavailableingovernment facilities,66%inFBHSfacilitiesand81%inprivatepharmacies. b) PublicandFBHSfacilitiesexperiencestockͲoutsofbasicessentialmedicinesforabout46 and14daysperyearrespectively.Thepublicsectorsupplychainisespeciallyproneto significantinterruptionsandcriticalstockouts,extendingbeyond30oreven90 consecutivedays. c) KEMSAandMEDShavehighavailabilityandvirtuallynostockͲoutsofbasicessential medicinesandtheymaintainadequatemedicinestockrecords. d) Theproportionofprescribedmedicinesthatwereactuallydispensedtopatientswas98% inFBHSfacilitiescomparedwith86%inpublicfacilities.Therefore,patientsweremore likelytoobtainallprescribedmedicinesfromtheFBHSfacilities.

MedicinePricesandAffordability a) ProcurementbyKEMSAandMEDSisalmostexclusivelyforgenericproducts,andthey obtainpriceͲefficiencywellbelowIRPs.WithanMPRof0.44,KEMSAobtains comparativelylowerprocurementpricesthanMEDSwithanMPRof0.61. b) Patientsobtainingmedicinesfromthepublicsectorfacecomparativelylowerorno financial barriers. Most(89%)surveyedmedicineswereissuedforfreeinthepublic sector,comparedwith15%inFBHSfacilitiesandnoneintheprivatepharmacies. c) Patientprices(wherecharged)inthepublicsectorwereabout40%lowerthanthosein theFBHSfacilities,andabout50%lowerthanthoseintheprivatesector. d) PriceschargedtopatientsforessentialmedicinesinthepublicandFBHSfacilities,areat leastfourtimeshigherthantherespectiveprocurementpricesatthecentrallevel. e) Fortheconditionsstudied,andwithreferencetotheminimumwage,individual treatmentswouldbefairlyaffordableinallsectorsandespeciallysointhepublicsector.

46 RationalUseofMedicines a) ThenationalSTGsandEMLͲkeytoolsforpromotingRUMͲwerenotavailabletomost healthcareworkersinallsectors.NationalSTGswereavailablein42%and25%ofpublic andFBHSfacilitiesrespectivelywhereastheEMLwasavailablein39%and47%ofthese facilitiesrespectively. b) InpublicandFBHSsectors,outpatientprescribingofinjectionsinpublicandFBHS facilitieswas13%and27%respectively,againstareference(target)valueof20%. c) However,prescribingofantibioticswashigh,beingmorethantwicethereferencevalue andhighestinpublicfacilities.Theproportionofpatientsprescribedanantibioticinthe publicandFBHSfacilitieswas77%and68%respectively,againstareferenceof30%. d) Prescribingbygenericnamewasextremelylow.Only32%and35%ofmedicineswere prescribedbygenericnameinthegovernmentandFBHSfacilitiesrespectively. e) Amedianof93.4%wasfoundformedicinesprescribedaccordingtothenationalEMLin thepublichealthfacilities,indicatingverygoodadherenceofprescriberstothislist. f) Adherenceofprescriberstostandardtreatmentguidelinesismixedandinconsistentin bothsectors.Whereasthereissomeconformancetorecommendedfirstlinetreatments, therewasoverallhighprescribingofantibioticswherenotindicated. g) Labelingofmedicineswasinadequateinallsectorsandcriticallylowinpublicfacilities. Only5%ofmedicinesatpublichealthfacilitieswereadequatelylabeledcomparedwith 21%and40%inFBHSfacilitiesandprivatepharmaciesrespectively. h) Themajorityofpatientshadfairlyadequateknowledgeofhowtotakethemedicines dispensed.Adequacyofthisknowledgewaslower(77%)forpatientsobtainingmedicines frompublicfacilities,comparedwith87%forFBHSfacilitiesand93%forprivate pharmacies.

HealthProfessionalsProfiles a) InthepublicandFBHSsectors,fewfacilities(38%and31%respectively)compliedwith thelawconcerningmedicinesdispensingbyqualifiedpharmaceuticalpersonnel. o Pharmacistswerefounddispensinginonly19%and6%ofpublicandFBHSfacilities respectively;pharmaceuticaltechnologistsin28%ofbothpublicandFBHSfacilities. o Dispensingwaslargelydonebyunqualifiedpersonnel.Inparticular,unqualified personnelwerefounddispensingin41%ofpublicfacilities,comparedto25%ofFBHS facilities. b) Licensedprivatepharmacieslargelycomplywiththelawondispensingbyqualified personnel:overall33%and61%hadapharmacistandapharmaceuticaltechnologist respectively,and81%compliedwiththelaw. c) Untrainedstaffwasthemostfrequentdispenserinpublicfacilities(42%);nursesinFBHS facilities(47%)andpharmaceuticaltechnologistsinprivatepharmacies(61%). d) Pharmacyinternswerealmostexclusivelyfoundinthepublicsector(25%offacilities). e) Theclinicalofficer,followedbythenurse,wasthemostfrequentprescriber.Aclinical officerwasprescribingin53%ofpublicand61%ofFBHSfacilitiesrespectively;anda nursewasprescribingin42%and39%ofthesefacilitiesrespectively. f) ThemedicaldoctorwaspresentinlessthanonethirdofgovernmentandFBHSfacilities, andwasactuallyfoundprescribingin17%and28%oftheserespectively. g) Untrainedstaffwasfoundprescribingin14%ofpublicfacilitiesand6%ofFBHSfacilities.

47 6.DISCUSSION

Essential Medicines to treat common diseases should be available in all health facilities, especiallythosewherethepooraccesshealthservices.Measuresofavailabilityrefertothe actualsituationonthedayofthesurvey.Theyaredependentonthenumberofmedicines studiedandtheirscopewithrespecttothehealthprioritiesthathaveevolvedwithprevailing policies and practices of the health system. This survey reports an inverse variation in availability of three expanded lists with respect to number and scope of medicines. For example,availabilityofthe15basicmedicines(Annex6)was85%andaboveinallsectors.In comparison,forthebroaderglobalandtheMMePAlists(32and36medicinesrespectively), availabilitywasmuchlowerin allsectors.Mostnotably,thepublicandFBHSfacilitieshad only about 66% of these medicines available. These findings infer that, for the full list of medicinesontheEML,availabilitywouldbelow. MedicinestockͲoutsinhealthfacilitiespointtoweaknessesinthedistributionsystem,and low overall performance of the supply chain. Any stock out of key medicines is a serious occurrence,sincepatientswouldfailtoobtainthemedicinewhenneeded.KEMSAandMEDS had virtually no stockͲouts of basic medicines and maintained complete records for all medicines,reflectingadequatestockmanagementatthesecentralwarehouses.Againstthis finding,themoreseverestockͲoutsinpublichealthfacilitiesrepresentinadequaciesinthe currentsystemformedicinesdistributionandreplenishment.StockͲoutsextendingbeyond 30daysareserious,andthosebeyond90dayscriticallyjeopardizehealthservicedelivery. Thelowperformanceofhealthfacilitiescomparedwiththecentralwarehousesmayreflecta lackofsystematicinvestmentinpharmaceuticalservicesacrossalllevelsofthehealthcare system.Thisisfurthersupportedbythefindingofincompletestockrecordsfor23%ofthe medicines surveyed in public facilities. Adequate and complete stock records are a preͲ requisiteforproperquantificationandstockmanagement,whichensurehighavailabilityand minimizestockͲouts.WhereastheFBHSfacilitiesshowedbetterperformancecomparedwith publicfacilities,thefindingshighlightgapsinthissector,especiallyintermsofstockͲoutsand inadequatestockrecords. The low proportion of public facilities with qualified pharmaceutical personnel is further evidence of skewed investment in pharmaceutical services, and a major hindrance to effectivehealthcaredelivery.Thiscorrelateswiththelowperformanceofhealthfacilities, reflectedininadequaterecordsandgrosslyinadequatelabelingofmedicines.Morecritically, thesafetyofpatientsisjeopardizedwhenunqualified personnelassumeresponsibilityfor handlinganddispensingmedicines,includingtheprovisionofdruginformationandpatient advice.Comparedwithprivatefacilities,thelowercomplianceofpublicandFBHSfacilities representsthecurrentlackofenforcementofregulatoryrequirementsfortheseproviders. Thisisattributabletothelackofseparationofroles(regulatoryandserviceprovision)inthe MinistryofMedicalServices.Thedispensingofmedicinesbyunqualifiedpersonnelinpublic facilitiesisparticularlyunacceptable.

A very positive finding is that KEMSA and MEDS are almost exclusively procuring generic productsand areobtainingpriceͲefficiencyin procurementwellbelowIRPs.Furthermore, whenpublicsectorfacilitiesprovidethemajority(89%)ofthesemedicinesforfree,thenthe price barrier that people may face when accessing medicines is significantly lowered. However,giventherelativelylow(67%)availabilityandfrequentstockͲoutsofthesurveyed

48 medicines, the full potential of this sector to positively impact access cannot be realized. Furthermore,patientpricesdonotreflectthebenefitsofefficientcentralizedprocurement. Forsomemedicines,thereisafourͲfoldincreaseinthefinalpricestopatients,representing disͲconnectbetweenpricingstructuresattheprocurementlevelandthoseinhealthfacilities. SinceKEMSAissuesmedicinestohealthfacilitiesatprocurementcost,chargingpatientsfour timestheKEMSApricemayindicatelackofpolicyguidanceonpricingofpubliclyprocured medicines,throughwhichpatientswouldobtainthefullpricebenefitsofbulkprocurement. Thesurveydemonstratesthatthepublic,FBHSandprivatesectorsapproachthepricingof medicinesdifferently,andpatientsobtainingmedicinesfromthepublicsectorgenerallyface lowerornofinancialbarriers.Whereastheprivatesectorchargedpatientsforallmedicines, thepublicsectorissued89%ofthemedicinesforfree,comparedwithabout15%inFBHS facilities. This infers good compliance of the public sector with Government policies on issuanceofmedicinesforfree.Furthermore,ofthemedicinesthatwerechargedfor,patient pricesinthepublicsectorwereabout40%lowerthanthoseintheFBHSfacilities,andabout 50%lowerthanthoseintheprivatesector.OutͲofͲpocketmedicinesexpenditureisawellͲ documented barrier to access to medicines and appropriate treatment, especially for the poor.TheprovisionoffreemedicinesforoutpatientsinpublicͲsectorhealthfacilitieshelpsto improveaccesstoessentialmedicines,especiallyforthosewhocouldnotaffordtoobtain medicinesfromalternativesources. Theassessmentofaffordabilitywasdonewithreferencetotheminimumgovernmentwage, and the selected individual treatments would be fairly affordable in all the sectors and especiallyinthepublicsector.However,itshouldbenotedthatthisaffordabilityonlyrefers tomedicineprices,andnotothertreatmentcostssuchasconsultationordiagnostictests.In reality,manypeopleinKenyaareunemployed,orininformalemploymentwheretheyearn lessthantheminimumwage.Assuch,eventreatmentsthatwouldappearaffordablemaybe too costly for the poorest in the population. Furthermore, whereas individual treatments mayappearaffordable,thetreatmentofcoͲmorbiditiesorchronicconditionsoftenrequires acombinationofmedicines,andhencethecostoftreatingandmanagingachroniccondition suchasasthma,diabetes,andcardiovasculardiseaseislikelytobemoreunaffordablethanis reported in this study. The burden of treatment costs may be further compounded when more than one family member requires treatment, and some of the medicines are unavailableinpublicfacilities. The low incidence of expired medicines in government, FBHS and private facilities and central warehouses, indicates that effective measures are in place in all sectors to guard againstexpiryofmedicines.Thisinfersaminimallikelihoodthatexpiredmedicinescouldbe dispensedtopatients.Incontrast,storageconditionsinpublichealthfacilitiesarecritically inadequate,puttingatriskthequalityofmedicinesdistributedthroughthissector.Compared to 2003, storage facilities for medicines have deteriorated or remained inadequate both centrallyandinhealthfacilitiesinthepublicsector.Inparticular,theKEMSAwarehousemet only 50% of the minimum criteria for storage conditions, and public facilities about 60%. BecauseKEMSAsuppliesthemajorityofthehealthfacilitiesinthecountryͲincludingsome FBHS and private facilities Ͳ the quality of publicly procured medicines is at risk through inappropriatestorageconditions.ItisnoteworthythatthecentralFBHSwarehousemetall the criteria, suggesting that systems are in place and resources deployed to betterensure properconservationandhandlingofmedicinesinMEDS.

49 KeytoolsforpromotingRUMwerenotavailableinmosthealthfacilities,andthisisreflected inthemixedfindingsonprescribinganddispensingpractices.Prescribersinpublicfacilities were largely prescribing those medicines provided through the public supply system44, suggestingahighdegreeofownershipofthisrestrictedlist,whichmaybeattributabletothe consultative process applied in annual reviews of the list. The FBHS has a similar review processwhichlargelyinvolvesMEDSandprescribersinFBHSfacilities.Intheabsenceofan updated national EML (as was the case during the survey) the supply lists for KEMSA and MEDSmaybesimilarbutnotidentical,andnotsurprisingly,prescribingintheFBHSfacilities conformedlesstotheKEMSAList.Further,whilepolyͲpharmacywasnotamajorproblemin both the public and FBHS sectors and outpatient prescribing of injections was within the reference levels, antibiotic prescribing was high in both sectors and highest in the public facilities;andprescribingbygenericnamewasextremelylow.Prescribingbybrandname, especiallywherethemedicineisoutofstockinthefacility,mayleadtothepatientspaying unnecessarilyhighpricesforexpensivebrandedproductsintheprivatesector.

ThefindingsonadherencetoSTGsfortracerconditionsaremixed.Whereasthereissome conformance with recommended first line treatments, e.g. ORS for nonͲbacterial diarrhea andafirstlineantibioticformildͲmoderatepneumonia,notallchildrenwereprescribedORS (medianof80%forpublicand60%forFBHSfacilities)andmanypatientsreceivedantibiotics thatwerenotindicated.

In the public and FBHS sectors, few facilities adhere to the law concerning dispensing by qualified pharmaceutical personnel and dispensing of medicines was largely done by unqualifiedpersonnel.Itisespeciallynoteworthythatuntrainedstaffwasthemostfrequent dispenserfoundinthepublicsector,suggestingthatdispensingofmedicinesbyunqualified personnelwaswidespreadinpublicfacilities.Itisthereforenotsurprisingthatlabellingof medicineswascriticallyinadequateinthesefacilities,andpatientknowledgeonhowtotake dispensedmedicineswaslowcomparedwithothersectors.Itcanbeinferredthatpatient safetyisseriouslycompromisedbythewidespreaddispensingbyunqualifiedpersonnel.This findingpointstotheneedforeffectiveregulatoryoversightofpublicandFBHSfacilities,to ensureconformancewiththelaw.Itisnotablethatsomeaspectsofpharmaceuticalservices were more adequate in FBHS facilities, compared with public facilities; this may be attributabletothesystematicskillsupgradingprovidedbytheFBHSservices. Medicines’ prescribing is mostly done by clinical officers and nurses in public and FBHS facilities, and they constitute critical cadres for promoting RUM. This importance is underscoredbythefindingthatmedicaldoctorswerepresentinlessthanonethirdofpublic and FBHS facilities, and were actually found prescribing in fewer of these. However, untrained personnel were sometimes found prescribing in public and FBHS facilities, more frequentlyinpublicfacilities.Thissituationseriouslycompromisespatientsafety,aswellas the quality and credibility of health services. Although norms and standards have been defined for ensuring effective delivery of the KEPH, current staffing levels for clinical and pharmaceuticalpersonnelarewellbelowthesenorms.

44The public sector formulary list (i.e. KEMSA list) was used as the reference EML for this study, becausethenationalEMLwasbeingrevisedatthetimeofthesurvey.

50 7.CONCLUSIONS

Thissurveyaimedtoprovideuptodateinformationonaccesstoessentialmedicines,with respect to the performance of the health system, and the achievement of expected outcomes. Where feasible, progress is identified through comparison with 2003 baseline assessment.Fromthefindingsofthissurvey,itcanbeconcludedthat:

The majority of basic essential medicines to treat common conditions at primary care levelareavailableandfairlyaffordabletoKenyansthroughthepublic,FBHSandprivate sectors. But medicine stockͲouts are prevalent and sometimes critical and essential medicinesforabroaderscopeofhealthneedsarelessavailable. CentralizedbulkprocurementofessentialmedicinesthroughKEMSAandMEDSispriceͲ efficientandgenerallymaintainsadequatestocksofbasicessentialmedicines. Thepricebarrierthatpeoplemayfacewhenaccessingmedicinesissignificantlylessin thepublicsector.Patientsobtainthemajorityofbasicessentialmedicinesforfree,orpay the lowest prices comparatively. However, frequent stockͲouts are a major barrier to access,especiallyforthepoor. The FBHS play a role in lowering the price barrier for medicines. Some medicines are issuedforfreeandpatientpricesaregenerallylowerthantheprivatesector. The price efficiency of centralized bulk procurement is not sustained in the pricing of medicinesbythepublicandFBHSsupplysystems.Wheremedicinesarenotissuedfor free,patientspayaroundfourtimestheprocurementpricesinbothsectors. The storage infrastructure for medicines in the public sector is critically inadequate throughout the supply chain, putting at risk the quality of medicines provided through thissector.StorageinfrastructureinFBHSfacilitiesisalsoinadequate. ThereismixedperformanceonRUMacrossallsectors,withsomeadherencetoSTGsbut highprescribingofantibioticsandlowprescribingbygenericname.Thismayresultfrom a lack of policy guidance or strategic approach to guide health sector investment in promotingRUM. The health sector faces a critical shortage of qualified pharmaceutical personnel to managemedicinessupply,dispensinganduse.WithabouttwothirdsofpublicandFBHS facilities lacking qualified personnel, pharmaceutical services are deficient: stockͲouts, inadequaterecords,inadequatedispensingpracticesandirrationaluseareconsequences ofskewedprioritiesanduncoordinatedinvestmentinpharmaceuticalservices. Regulationsgoverningpharmaceuticalservicesarenoteffectivelyenforcedinthepublic andFBHSsectors;andtoalesserextenttheprivatesector.Thisisaseriousthreatbothto publicsafetyandqualitypharmaceuticalservicesdelivery. Licensed private pharmacies have a significant role in improving access to medicines. Basicessentialmedicinesareavailable,fairlyaffordableandlargelydispensedbyqualified personnelincompliancewiththelaw;andthesectorscoreshigheronmostdispensing indicators.

Overall,findingsofthissurveyindicatestagnatingordeterioratingperformanceofthepublic sectorsince2003.Whereasavailabilityhasnotchangedsignificantly,stockͲoutsinfacilities haveincreased;andstockrecordsandlabellingofmedicineshavedeteriorated.

51 8.RECOMMENDATIONS

The findings of this pharmaceutical situation assessment point to a mix of policies and strategiesthatneedtobeimplementedtoimproveaccesstoEssentialMedicinesandtheir appropriate use. The following are key recommendations addressed to Government, DevelopmentPartners,CivilSociety,FBHSandthePPB:

TotheGovernment a) Institutionalizeandintegratemonitoringandevaluationofpharmaceuticalserviceswithin thehealthsectorcoordinationandM&Eframework,toinformpoliciesandstrategiesfor improvingaccesstomedicines. b) Rationalize priorities and investments across the entire package of pharmaceutical serviceswithintheKEPH,totargetthediversegapsinaccesstoessentialmedicines.This would include appropriate personnel and storage infrastructure in line with published normsandstandards. c) Developpoliciestopromotetheuseofqualityassuredgenericproducts,asameansof sustainingaffordabilityofessentialmedicines. d) DeployqualifiedpersonneltopublicandFBHShealthfacilitiesincompliancewiththelaw, inordertosafeguardpatientsafetyandimprovemedicinesmanagement,prescribingand dispensing. e) Prioritize the upgrading of medicines storage infrastructure within the health infrastructureimprovementplan,withparticularfocusonKEMSA,publichealthfacilities andFBHSfacilities. f) DevelopandimplementacoordinatedstrategytopromoteRUM.Thismayinclude: x Institutionalized review, updating, dissemination and regular monitoring of the revisedStandardTreatmentGuidelinesandEssentialMedicinesList x CoordinatedandtargetedtrainingofhealthworkersonGoodPrescribingPractices, GoodDispensingPracticesandinjectionsafetypractices. x Monitoringthesupply,pricingandutilizationofspecificmedicines,e.g.injectionsand antibiotics. g) Sustain and enhance the efficiencies of public and FBHS pharmaceutical procurement, throughcollaborativemechanismssuchascoordinatedͲinformedbuying. h) Intheelaborationofhealthfinancingpolicies,ensurethatcoverageformedicinesisin linewiththeEssentialMedicinesConcept;andthatfinancialbarriersareeliminatedto thegreatestextentpossible. i) Enhance coordination of pharmaceutical issues within health sector coordinating framework,tofacilitatecomprehensivestrategiesandinvestmentsthatcapturethefull scopeofpharmaceuticalswithinoverallhealthsectorstrategicframework. ToDevelopmentPartnersinHealth–Kenya(DPHͲK) a) FacilitateacoordinatedandevidenceͲbasedapproachtopharmaceuticalservicessupport, inthecontextofexistinghealthsectorcoordinatingandinvestmentmechanisms. b) Support coordinated pharmaceutical sector M&E – including periodic comprehensive pharmaceuticalsituationassessmentsͲandintegrateintoongoingprogrammes. c) EnhancesupporttohumanresourcesforpharmaceuticalservicesinthepublicandFBHS sectorswithinthecontextoftheHumanResourceforHealthStrategicPlan.

52 FaithBasedHealthServices(FBHS) a) In consultation with Government and Development Partners, institute mechanisms to improveaffordabilityofkeymedicinesinFBHSfacilities,inamannerthatsupportsand maintainshighavailability.Thismayinvolveexpandedsubsidizationandrationalizationof currenthealthsectorinvestmentsonpharmaceuticals. CivilSociety a) Advocate for and support evidenceͲbased programming and investment in pharmaceuticalservices. b) EnhanceconsumerawarenessonthecorefactorsaffectingaccesstoEssentialMedicines, andtheirroleinimprovingappropriateuseofmedicines. Pharmacy&PoisonsBoard a) Enforcefullcompliancewiththelawonthehandlinganddispensingofmedicines.This shouldapplyequallytothepublic,FBHSandprivatesectorhealthproviders. b) LiaisewiththeKMPDBtoensurethatprescribingofmedicinesisdoneinconformance withthelaw.

53 ANNEXES

54 55 ANNEX 1: SUMMARY LIST OF INDICATORS AND CORRESPONDING SURVEYFORMSUSEDFORDATACOLLECTION Indicator SurveyForm AvailabilityandAffordability 1 a)Availabilityofkeymedicinesingovernment&FBHShealthfacilities,privatedrug 1,10,15,18 outletsandcentralwarehousessupplyinggovernmentandFBHShealthfacilities b)Meanavailabilityoforiginatorbrandandgenericmedicinesinthegovernmentand MMePA privatesectors 2 %ofprescribedmedicinesdispensedoradministeredtopatientsatgovernmentand 6,22 FBHShealthfacilitydispensaries 3 AveragestockͲoutdurationingovernment&FBHShealthfacilities,andcentral 4,16,20 warehousessupplyingthese 4 Adequaterecordkeepingingovernment&FBHShealthfacilities,andcentral 4,16,20 warehousessupplyingthese 5 Geographicalaccessibilityofgovernment&FBHShealthfacilities,andprivatedrug 6,14,22 outlets 6 Indicatorsrelatedtoaffordabilityandpricesofmedicines: a) Patientpricesforgenericandinnovatordruginthegovernmentandprivatesectors MMePA b) Pricesofgenericandinnovatordrugingovernmentandprivatesectorcompared withinternationalpriceindex c) Affordability:ratioofcosttotreatcommonconditionsusingstandardregimen,to 3,19 thelowestdailygovernmentworkerwageformoderatepneumonia,diabetesand asthma(inchildren)(no.ofdayswagestopurchaselowestpricedgenericmedicines fromgovernmentandprivatesectors) Quality 1 %medicinesexpiredingovernment&FBHShealthfacilitydispensaries,privatedrug 1,10,15,18 outlets,andcentralwarehousessupplyingthegovernment&FBHSfacilities 2 Adequacyofstorageconditionsandofhandlingofmedicinesingovernmenthealth 5,13,17,21 facilities,warehousessupplyingthegovernmentsector,andFBHShealthfacilities RationalUseofMedicines 1 %medicinesadequatelylabelledatgovernment&FBHShealthfacilitydispensaries,and 6,14,22 privatedrugoutlets 2 %patientsknowledgeofhowtotakemedicinesatgovernment&FBHShealthfacilities, 6,14,22 andprivatedrugoutlets 3 Averageno.medicinesperprescriptionatgovernmentandFBHShealthfacilities 6,7,22,23 4 %patientsprescribedantibioticsingovernmentandFBHShealthfacilities 7,23 5 %patientsprescribedinjectionsingovernmentandFBHShealthfacilities 7,23 6 %prescribedmedicinesontheEMLatgovernmentandFBHShealthfacilities 7,23 7 %medicinesprescribedbygenericname(INN)atgovernmentandFBHShealthfacilities 7,23 8 AvailabilityofstandardtreatmentguidelinesatgovernmentandFBHShealthfacilities 8,24 9 AvailabilityofessentialmedicineslistatgovernmentandFBHShealthfacilities 8,24 10 %tracercasestreatedaccordingtorecommendedtreatmentprotocol/guideat 9,25 governmentandFBHShealthfacilities 11 %prescriptionmedicinesboughtwithoutaprescription 14 HealthProfessionalsProfiles 1 %facilitiescomplyingwiththelaw(presenceofapharmacist) SectionA,C,E 2 %facilitieswithpharmacist,nurse,pharmacyaide/assistantoruntrainedstaff SectionA,C,E dispensing 3 %facilitieswithdoctor,nurse,trainedhealthworker/healthaideprescribing SectionB,F 4 %facilitieswithprescribertrainedinRDU SectionB,F

56 ANNEX2:LEVELIISURVEYFORMS45 SectionA:SurveyForms1Ͳ6 SurveyForms GovernmentHealthFacilityPharmacies/Dispensaries %keymedicinesavailable SF1 %medicinesexpired Affordabilityoftreatmentforadultsandchildrenunder5years SF3 (pneumoniawithnohospitalization) SF4 AveragestockͲoutduration Adequaterecordkeeping

SF5 Adequatestorageconditionsandhandlingofmedicinesinstoreroom&dispensingarea

Averagenumberofmedicinesperprescription %medicinesdispensedoradministered %medicinesadequatelylabelled SF6 %patientsknowinghowtotakemedicines Averagecostofmedicines Geographicalaccessibilityofdispensingfacilities Generalinformation:Governmenthealthfacilitypharmacy Facility Date

Region Investigator1

Investigator2 Doesthelawrequireapharmacist/pharmaceuticaltechnologisttobepresentduringhoursof operationofgovernment/government/FBHSpharmacies/medicinesoutlets? Yes No Isapharmacist/PharmTechpresentatthetimeofthevisit? Yes No Assessment 1 complieswiththelaw(items1and2arebothYes) 2 doesnotcomplywiththelaw(item1Yesanditem2No) Whoisdispensingduringthetimeofvisit?(checkallthatapply) Pharmacist (1=Yes;0=No) Pharmacyassistant(certificate) (1=Yes;0=No) Nurse (1=Yes;0=No) PharmacyIntern/Student (1=Yes;0=No) PharmTech (1=Yes;0=No) Untrainedstaff(1=Yes;0=No)

45Note:certainsurveyformsapplicabletotheFBHSorprivatesectorshavenotbeenincludedInthe Annexesastheyareidenticaltoincludedformsusedingovernmentfacilities

57 Facility#_____ (1–36) SurveyForm1:GovernmentHealthFacilityPharmacy Indicators:%keymedicinesavailable %medicinesexpired Facility Date Province Investigator1 District Investigator2 Instock Expiredmedicines KeyMedicinesforCommonConditions Yes=1, onshelves No=0 Yes=1,No=0 [A] [B] [C] 1 ORS(WHOrecommendedformula)(noteifoldformula) 2 Zincsulfatetablets20mg 3 Amoxicillincapsules250mgor500mg 4 Amoxicillinsuspension125mg/5mL 5 Artemether/Lumefantrine)tablets20/120mg(anypacksize) Ferroussalttablets(anysalt,eitheraloneorincombination 6 withfolicacid) 7 Albendazoletablets400mg 8 Tetracyclineeyeointment 9 Adrenalininjection1mg/mL 10 Clotrimazolecream1% 11 Paracetamoltablets500mg 12 Paracetamolsyrup/suspension120mg/5mL 13 Metronidazoletablets200mg 14 Ciprofloxacintablets250mg(orNorfloxacintablets400mg) 15 Chlorpheniraminesyrup2mg/5mL [B1]=Sum [C1]=SumofC= ofB= [B2]=%in [C2]=%expired= stock=B1÷ C1÷B1x100= 15x100=

Notes: [A]Thelistof15keymedicineshasbeenidentifiedatnationallevelandispreprintedonthesurveyforms. [B]Mark“1”ifanyquantityofanydosageformofthemedicinesisinstockinthefacilityonthedayofthevisit. Mark“0”ifthemedicineisnotavailableinstock.Addthetotalatthebottom[B1].Calculatethepercentageinstock[B2] bydividingthetotalinstock[B1]by15andmultiplyingby100. [C]Forallmedicinesinstock,checkifanyofthestockisexpired.Ifanyamountofamedicinehasexpiredmark“1”for yes.Donotcountexpiredmedicinesstoredinaseparateareafordestruction.Addthetotalatthebottom[C1].Calculate the percentage expired [C2] by dividing the total expired [C1] by the total number of medicines in stock [B1] and multiplyingby100.

SurveyForm3:GovernmentHealthFacilityPharmacy Indicators:AffordabilityoftreatmentͲmoderatepneumoniaforadults& Facility#_____ childrenunder5yearsofage(equivalentno.ofdays’wages) (1–36) Facility Date Province Investigator1 District Investigator2 No.ofunits Unitprice Totalcostof Equivalent Medicine/ neededto (onevial, treatment no.days INNandPreparation complete taborcap) [D]=BxC wages treatment (KES) (KES) [F]=D÷E [A] [B] [C] [D] [F] Moderatepneumonia(withouthospitalization):TreatmentofChoice: Adult:Amoxicillin250mgcapsules 42caps [F¹]= Child<5:Amoxicillin125mg/5mLsusp100mL 1bottle [F²]= Otheradultcondition:DiabetesͲInsulindependent(withouthospitalization) HumanInsulin30/70 10mLvial [F³]= Otherpaediatriccondition:Asthma(withouthospitalization)ͲChild<5treatmentofchoice: Beclomethasoneinhaler50mcg/dose 1inhaler [F4]= [E]=Lowestdailygovernmentsalary=KES249 Notes: [A]Usingstandardtreatmentguidelines,thetreatmentofchoiceandtherecommendedpreparation(dosagestrength&form) wereidentifiedandpreͲprintedformoderatepneumonia(nohospitalisation).Donotincludemedicinesusedonlyforreliefof mildsymptoms,e.g.paracetamolorcoughsyrup. [B]Thenumberofunitsofeachmedicineneededforthedurationoftreatment(basedonSTG)shouldbeidentifiedatthe nationallevelandpreprintedonthesurveyforms. Iftheotherconditionisachronicillness,includethenumberofunitsinamonth’ssupply. [C]Indicateinlocalcurrencytheunitpriceorthepricethefacilitychargespatientsforeachmedicine.Thelowestpriced brandedorgenericequivalentmedicineshouldbeused.Ifthereareflatchargespaidforeachmedicinegiventopatients,this amountshouldberecordedasthepriceofthemedicine.Indicate“0”ifmedicinesaregivenfree.Addcostofsyringestothe unitprice,ifapplicable. [D]Calculatetotalcostoftreatment[D]bymultiplyingthenumberofunitsneeded[B]byunitprice[C].Ifpatientsarecharged aflatfeefortreatmentcourse,recordthisastotalcostoftreatment. [E]Identifyatthenationallevelandpreprintontheformthelowestdailygovernmentsalary.Iftheweeklysalaryisknown, dividethisby7toobtainthedailysalary.Ifthemonthlysalaryisknown,dividethisby30toobtainthedailysalary. [F]Calculatethenumberofdayswagesneededtopayfortreatmentbydividingthecostoftreatment[D]bythelowestdaily governmentsalary[E]. Example: No.ofunits Totalcostof Unitprice Equivalentno. Medicine/ neededto treatment (onevial/tab/cap) dayswages INNandPreparation complete [D]=BxC (KES) [F]=D÷E treatment (KES) [A] [B] [C] [D] [F] Moderatepneumonia(withouthospitalization) Procainepenicillin:1g(1MU) 3injections 280 (inj+ syringe) 840 11.2 Amoxicillin:125mg/mlsusp.100ml 1bottle 220 220 2.93 [E]=Lowestdailygovernmentsalary=KES249 59

SurveyForm4:GovernmentHealthFacilityPharmacy Facility#_____ Indicators:AveragestockͲoutduration Adequaterecordkeeping (1–36) Facility Date Province Investigator1 District Investigator2 Onlycollectdataformedicineswithrecordscoveringatleast6monthswithinthepast12months Recordscover No.of No.ofdays Equivalentno. atleast6mths Keymedicinesfor days coveredby ofstockͲout withinpast12 commonconditions outof review(at days/year mthsYes=1, stock least6mths) [E]=Cx365÷D No=0 # [A] [B] [C] [D] [E] ORS(WHOrecommendedformula) 1 (noteifoldformula) 2 Zincsulfatetablets20mg 3 Amoxicillincapsules250mgor500mg 4 Amoxicillinsusp.125mg/5mL 5 ALtablets20/120mg(anypacksize) Ferroustablets(anysalt,eitheralone 6 orincombinationwithfolicacid) 7 Albendazoletablets400mg 8 Tetracyclineeyeointment 9 Adrenalininjection1mg/mL 10 Clotrimazolecream1% 11 Paracetamoltablets500mg 12 Paracetamolsyrup/susp120mg/5mL 13 Metronidazoletablets200mg Ciprofloxacintablets250mgor 14 Norfloxacintablets400mg 15 Chlorpheniraminesyrup2mg/5mL [B1]=SumofB= [E1]=SumofE= [B2]=%adeq. records=B1÷15 x100= [F]=AveragenumberofstockͲoutdays=E1÷B1= Notes: [A]Thelistof15keymedicinesidentifiedforSurveyForm1ispreprintedonthisform. [B]Gothroughthestockcardsandindicatewhichmedicineshaverecordscoveringatleast6monthswithintheprevious 12 months. Add the total at the bottom [B1]. Calculate the % of medicines with adequate records [B2] by dividing the numberofmedicineswithrecordscoveringatleast6months[B1]by15andmultiplyingby100. [C]Thereviewshouldcover6Ͳ12months.Gothroughthestockcardscoveringthereviewperiod.Indicatethenumberof dayseachmedicinewasnotavailableormarked“0”onthecard.Amedicineisconsideredinstockifanyquantityofitis availableingenericorbrand. [D]Indicatethenumberofdaysactuallyreviewedforeachmedicine. [E]ComputetheequivalentnumberofstockͲoutdays/yearforeachmedicinebymultiplyingthenumberofdaysoutof stock[C]by365anddividingbythenumberofdayscoveredbythereview[D].AddthetotalnumberofstockͲoutdays[E1]. [F]CalculatetheaveragenumberofstockͲoutdaysbydividingthetotalnumberofstockͲoutdays[E1]bythetotalnumber ofmedicinesreviewed[B1].

SurveyForm5:GovernmentHealthFacilityPharmacy/Dispensary Indicator: Adequatestorageconditionsandhandlingofmedicinesin Facility#_____ storeroomanddispensingarea (1–36) Facility Date Province Investigator1 District Investigator2 Storeroom Dispensing True=1, Area/Room Checklist False=0 True=1,False=0 [A] [B] 1.Thereisamethodinplacetocontroltemperature(e.g.roof& ceilingwithspacebetweentheminhotclimates,air conditioners,fans,etc) 2.Therearewindowsthatcanbeopenedor thereareairvents 3.Directsunlightcannotenterthearea(e.g.windowpanesare paintedortherearecurtains/blindstoprotectagainstthesun) 4.Areaisfreefrommoisture (e.g.leakingceiling,roof,drains,taps,etc.)

5.Thereisacoldstorageinthefacility(fridge/coldroom)

6.Thereisaregularlyfilledcoldstoragetemperaturechart

7.Medicinesarenotstoreddirectlyonthefloor

8.Medicinesarestoredinasystematicway(e.g.alphabetical, pharmacological)

9.MedicinesarestoredfirstͲexpiryͲfirstout(FEFO)

10.Thereisnoevidenceofpestsinthearea

11.Tablets/capsulesarenotmanipulatedbynakedhand

1 1 [A ] = Sum of [B ]=SumofB= A= [A2] = Score = [B2]=Score=B1÷ A1÷10x100= 11x100= Notes: [A]Indicate“1”ifallpartsofthestatementaretrueforthestoreroomand“0”ifanypartisfalse.Sumthetotal number of true statements in [A1]. Calculate the score for the storeroom [A2] by dividing the sum of true statements[A1]by10andmultiplyingby100. [B]Indicate“1”ifallpartsofthestatementaretrueforthedispensingroomand“0”ifanypartisfalse.Sumthe totalnumberoftruestatementsin[B1].Calculatethescoreforthedispensingroom[B2]bydividingthesumoftrue statements[B1]by10andmultiplyingby100. *Itmaybenecessarytolookelsewhereinthefacilityforsomeofthecriteria(e.g.refrigerator)

61 Facility #_____ (1– 36) SurveyForm6:Government HealthFacility Pharmacy/Dispensary Patient CareExitInterview Indicators: Average number ofmedicines perprescription %patients knowhowtotakemedicines %medicines dispensed oradministered Average costofmedicines %medicines adequately labelled Geographical accessibility offacilities Facility Date

Region Investigator 1 District Investigator 2 Amount Howlongdidittakefor Age(yrs) Patient No.of No.of knows how patient thepatient togettothe Patient 1)<5 No.of Howmuchdiditcost medicines medicines totake paidfor healthfacilitytoday? sex 2)5–15 medicines tocomehere? dispensed or adequately medicines? purchased 1)<30mins M/F 3)16–60 prescribed (KES) administered labelled Yes=1, medicines 2)31Ͳ60mins 4)>60 No=0 (KES) 3)>60mins [A] [B] [C] [D] [E] [F] [G] [H] [I] 1 2 up to

30 [A1]= [B1]=Sumof1= [C1]=Sum [D1]=SumofD [E1]=Sum [F1]=Sum [G1]=Sum [H1]=Sumof1= [I1]=SumofI= Sum [B2]=Sumof2= ofC= = ofE= ofF= ofG= [H2]=Sumof2= [I2]=Average cases= [B3]=Sumof3= [H3]=Sumof3= transport cost= 2 2 2 2 2 2 [A ]= [B4]=Sumof4= [C ]= [D ]=% [E ]=% [F ]=% [G ]= I1÷totalresponses = Sum Average dispensed =D1 adequately knowhow Average females= no.of ÷C1x100= labeled =E1 totake cost=G1÷ [I3]=Average

Amount Howlongdidittakefor Age(yrs) Patient No.of No.of knowshow patient thepatienttogettothe Patient 1)<5 No.of Howmuchdiditcost medicines medicines totake paidfor healthfacilitytoday? sex 2)5–15 medicines tocomehere? dispensedor adequately medicines? purchased 1)<30mins M/F 3)16–60 prescribed (KES) administered labelled Yes=1, medicines 2)31Ͳ60mins 4)>60 No=0 (KES) 3)>60mins [A] [B] [C] [D] [E] [F] [G] [H] [I] 1 [A3]=% medicines ÷D x100= medicines total transportcostto 1 1 1 1 females =C ÷A = =F ÷A x patients= minimumdailysalary 2 =A2÷A1 100= =[I ]÷[J]= x100= [J]=Lowestdailygovernmentsalary=249KSh Notes: [A&B]Interview30patientsleavingthedispensingarea/pharmacy.Obtainthesexandageofthepatient,notthoseofthepersonobtainingthemedicine.Usethenumberof patients/casesabletorespondtocorrespondingquestionsasdenominatorsfor(G,H,I,J,K) [A]Recordthenumberofcases[A1]andthenumberoffemales[A2].Calculatethe%offemalesbydividingthetotalnumberoffemales[A2]bythetotalnumberofcases[A1]and multiplyingby100. [C]Recordthenumberofmedicinesprescribedforeachpatient.Combinationmedicinesinonedosageformcountasonemedicine.Sumthenumberofmedicinesprescribedforall patients[C1].Calculateaveragenumberofmedicinesprescribed[C2]bydividingnumberofmedicinesprescribed[C1]bynumberofcases[A1]. [D]Recordthenumberofmedicinesdispensedoradministeredtoeachpatient.Sumthetotalnumber[D1].Calculatethe%ofmedicinesdispensed[D2]bydividingthenumberof medicinesgiventoallpatients[D1]bythetotalnumberofmedicinesprescribed[C1]andmultiplyingby100. [E]Recordthenumberofmedicineslabelledwithatleastthename&strengthofthemedicineandhowtotakeit(dose&frequency–inwords)*.Countonlymedicinesmeetingboth criteria.Sumthetotal[E1].Calculatethe%ofmedicinesadequatelylabelled[E2]bydividingthetotalnumberofadequatelylabelledmedicines[E1]bythetotalnumberofmedicines dispensed[D1]andmultiplyingby100. [F]Determineifpatient(oranadultaccompanyingapaediatricpatient)knowshowtotakeallmedicinesdispensed(patientknowsdosageanddurationofalldispensedmedicines*).Mark “1”onlyifpatientcancorrectlystatehowALLmedicinesshouldbetakenand“0”otherwise.Sumthetotal[F1].Calculatethe%ofpatientswhoknowhowtotakeallmedicines[F2]by dividingthetotalnumberwhoknowhowtotakeallmedicines[F1]bythetotalnumberinterviewed[A1]andmultiplyingby100. [G]RecordtheamounteachpatientpaidoutͲofͲpocketforallmedicinesreceivedatthefacility.Checkwithareceiptifpossible.Sumthetotalamount[G1].Calculatetheaverage medicinescostbydividingtheamountspaidformedicines[G1]bythetotalnumberinterviewedabletorespond. [H]Recordthetimeittookthepatienttogettothefacility.Indicatethecodes1Ͳ3.Sumthetotalofpatientsineachcategory[1Ͳ3]. [I]Notetravelcostinlocalcurrency(includingcostsforaccompanyingpersonͲwherepatientcouldnottravelalone).Sumthetotalamount[I1].Calculatetheaveragetransportcost[I2]by dividingtheamountspaidfortransport[J1]bythetotalnumberinterviewedpersonsabletorespond.Tocalculatethe=Averagetransportcosttominimumdailysalary[I3],dividethe averagetransportcostbytheminimumdailysalary[J]

SectionB:SurveyForms7–9 SurveyForms GovernmentHealthFacilities SF7* Averagenumberofmedicinesperprescription %patientsprescribedantibiotics %patientsprescribedinjections %prescribedmedicinesonEssentialMedicinesList(EML) %medicinesprescribedbygenericname(INN) SF8 AvailabilityofStandardTreatmentGuidelines(STG) AvailabilityofEssentialMedicinesList(EML) SF9 %tracercasestreatedaccordingtorecommendedtreatmentprotocol/guide *ForSF7:Useonlygeneraloutpatientrecords.DonotselectpatientsfromwellͲchildvisits,preͲ andpostͲnatalvisits,specialistconsultations,orevenseparateclinicsforadultsandpaediatric casesbecausetreatmentpracticesaredifferent. Generalinformation:Governmenthealthfacility FacilityDate

RegionInvestigator1

DistrictInvestigator2

1.Whoisprescribingduringthetimeofvisit?(checkallthatapply)*

doctor(1=Yes;0=No) nurse(1=Yes;0=No)

trainedhealthworker/healthaide(1=Yes;0=No)

clinicalofficer(1=Yes;0=No) untrainedhealthworker(1=Yes;0=No)

1.1Whoisthemostseniorprescriber?

doctor(1=Yes;0=No) nurse(1=Yes;0=No)

trainedhealthworker/healthaide(1=Yes;0=No)

clinicalofficer(1=Yes;0=No)

2. Has the most senior prescriber named in 1.1 attended rational use of medicines (RUM) Ͳ relatedtrainingwithinthelastyear?(Note:RUMcurriculumcanincludeanyofthefollowing: rational prescribing, essential medicine concept, use of IMCI or other clinical guidelines) Yes(=1) No(=0)

*Ifthereareseveralprescribers,interviewthemostseniorprescriberonly.

64 Facility#_____ (1–36) SurveyForm7:GovernmentHealthFacility:PrescribingIndicatorForm Indicators: Averagenumberofmedicinesperprescription;%prescribedmedicineson EML;%patientsprescribedantibiotics/injections;%medicinesprescribedby genericname Facility Date Region Investigator1

District Investigator2 Age(yrs) Antibiotic Injection No.of No.of No.ofRxd 1)<5 Sex Rxd Rxd medicinesRxd Type 2)6Ͳ15 medicine medicines M/F Yes=1 Yes=1, bygeneric R/P 3)16Ͳ60 sRxd onEML 4)>60 No=0 No=0 nameINN) [A] [B] [C] [D] [E] [F] [G] 1 2 Up to 30 [A]=Sumofcases [B1]=Sum [C1]= [D1]= [E1]= [F1]= [G1]= = offemales= SumofC= SumofD= SumofE= SumofF= SumofG= [A1+2]=Sumofpaed. [B2]=% [C2]=Ave. [D2]=% [E2]=% [F2]=% [G2]=%INN= cases=(1)+(2)= females= no.of receiving receiving EML=F1÷ G1÷C1x100= B1÷A1x medicines a/biotics= injections C1x100= P [A ]=%paediatric 100= =C1÷A1= D1÷A1x =E1÷A1x 1+2 cases=A ÷Ax100= 100= 100= Rxd=Prescribed; Notes [A]Fromoutpatienttreatmentrecords,select30patientsseenwithinthelast12months (R=retrospectivesampling).Ifrecordsarenotavailable,select30patientscurrentlybeingtreated(P=prospectivesampling). SamplecancombineR&P.Mark“R”ifpatientwasselectedretrospectively;“P”ifpatientwasselectedprospectively.Recordthe numberofcases[A]andthenumberofpaediatriccases[A1+2].Calculatethepercentageofpaediatriccasesbydividingthetotal numberofpaediatriccases[A1+2]bythetotalnumberofcases[A]&multiplyingby100. [B]Recordthenumberoffemales[B1].Calculatethepercentageoffemalesbydividingthetotalnumberoffemales[B1]bythe totalnumberofcases[A1]andmultiplyingby100. [C]Recordnumberofmedicines(chemicalentity,INN,generic)prescribed.Combinationmedicinesinonedosageformcountas onemedicine.Totalthenumberofmedicinesprescribed[C1].Calculateaveragenumberofmedicinesprescribed[C2]bydividing numberofmedicinesprescribed[C1]bynumberofcases[A1]. [D]Record“1”ifpatientwasprescribedanyantibioticsand“0”otherwise.Totalthecasesreceivingantibiotics[D1].Calculate percentageofcaseswithantibiotics[D2]bydividingnumberofcaseswithantibiotics[D1]bynumberofcases[A1]and multiplyingby100.(ForKenyaͲConsideronlyoral/injectableantiͲbacterialagents) [E]Record“1”ifpatientwasprescribedanyinjectionsand“0”otherwise.Totalthecasesreceivinginjections[E1].Calculate percentageofcasesreceivinginjections[E2]bydividingnumberofcaseswithinjections[E1]bytotalnumberofcases[A1]and multiplyingby100. [F]RecordnumberofprescribedmedicinesonthenationalEssentialMedicinesList(EML).Totalthenumberofprescribed medicinesontheEML[F1].CalculatethepercentageofprescribedmedicinesontheEML[F2]bydividingthenumberofmedicines ontheEML[F1]bythenumberofmedicinesprescribed[C1]andmultiplyingby100. [G]RecordnumberofmedicinesprescribedbyINN.TotalthenumberofmedicinesprescribedbyINN[G1].Calculatepercentage ofmedicinesprescribedbyINN[G2]bydividingnumberofmedicinesprescribedbyINN[G1]bynumberofmedicinesprescribed [C1]andmultiplyingby100. 65 SurveyForm8:GovernmentHealthFacility:EssentialMedicineInformation Indicators: AvailabilityofStandardTreatmentGuidelines(STG) Facility#_____ AvailabilityofEssentialMedicinesList(EML) (1–36) Facility Date

Region Investigator1

District Investigator2

Yes=1,No=0 StandardTreatmentGuidelines(STG)available [A] STGforpneumonia(aspartofcombinedordiseasespecificSTG) STGformalaria(aspartofcombinedordiseasespecificSTG) [A1]=BothSTGsarepresent= Yes=1,No=0 EssentialMedicinesList(EML)updatedwithinlast5yearsavailable [B] NationalEML 0 Provincial/DistrictEML(NotapplicabletoKenya) FacilityͲspecificEML OtherEML(describe): [B1]=AtleastonecurrentEMLispresent= Notes: [A]IdentifythesecondrequiredSTGatthenationallevelandpreprintontheform.This shouldbeforanimportantdiseaseintheregion,e.g.malariainendemicareasor hypertension.ChecktoseeifthereisacopyofeachoftheSTGseitheraspartofacombined STGoradiseaseͲspecificSTG.Record“1”ifthefacilityisabletopresentacopyofthe documentand“0”ifthefacilityisunabletopresentthedocument.IfbothSTGsarepresent record“1”in[A1]otherwiserecord“0”.

[B]Record“1”nexttoeachtypeofEMLupdatedwithinthelast5yearsthatisphysically presentinthefacility.IfthefacilityisunabletopresentthedocumentoriftheEML presentedhasnotbeenupdatedinthelast5years,record“0”.IfanycurrentEMLis available,mark“1”in[B1],otherwiserecord“0”.

66 SurveyForm9:GovernmentHealthFacility Indicator: %oftracercasestreatedaccordingto Facility#_____ recommendedtreatmentprotocol/guide (1–36) Facility Date

Region Investigator1

District Investigator2

%of Tracer Useofmedicinesbycase casesRxd Total No.of conditions& Yes=1,No=0[B] medicine no.of casesRxd medicines [E]= cases medicine prescribed D÷Cx [C] [D] [A] 1 2 3 4 5 6 7 8 9 10 100 [E] NonͲbacterialdiarrhoeainchildrenunder5years

Antidiarrhoeal and/or antispasmodic Mild/moderate(outpatient)pneumoniainchildrenunder5years [A1]Firstlineantibiotic(s)innationalSTG:amoxicillinsuspension125mg/5mLorcotrimoxazole suspension Prescribed>1 antibiotic NonͲpneumoniaacuterespiratorytractinfection(ARI)inpatientsofanyage

Anyantibiotic [A2]Optionaltracercondition1:Malaria Quininetablets Notes: [A]Atthenationallevel,identifyandpreprintontheformthefirstlineantibiotic(s)mentionedinthe nationalSTGforpneumonia[A1].Ifdataontreatmentofotherimportantlocalconditionsisdesired, preprint on the form the optional tracer conditions [A2] and the medicines that will be used to measurerecommendedornonͲrecommendedpractices. [B]Fromgeneraladultorpaediatricoutpatientrecords,select10patientencounterswitheachtarget condition.Ifpossible,chooseonlysinglediagnosisencounters.Write“1”or“0”foreachcaseselected toindicatewhetherornoteachtargetmedicinewasprescribed. [C]Totalthenumberofcasesineachrow. [D]Totalthenumberofcasesineachrowthatwereprescribedthetargetmedicine. [E]Foreachrow,calculatethepercentageofpatientsreceivingeachmedicine[E]bydividingthetotal number of cases that were prescribed each medicine [D] by the total number of cases [C] and multiplyingby100.

67 Surveyform15:Central/regional/districtwarehousesupplyingthepublicsector Central/districtwarehouse Indicator: %keymedicinesavailable %medicinesexpired Facility#____(1Ͳ5) Facility Date Region Investigator Expired Instock medicineson Keymedicinestotreatcommonconditions Yes=1,No=0 shelves Yes=1,No=0 [A] [B] [C] 1. ORS(newformula) 2. Amoxicillincapsules250mg/500mg 3. Amoxicillinsuspension125mg/5ml 4. Artemether/lumefantrine(20/120mg)tablets(anypack) 5. Ferroussalttablets(aloneorincombinationwithfolicacid) 6. Albendazole400mgtablets 7. Tetracyclineeyeointment1% 8. Povidoneiodine10%solution 9. Clotrimazolecream1% 10. Paracetamoltablets500mg 11. Paracetamol/syrupsuspension120mg/5ml 12. Metronidazoletablets200mg 13. Ciprofloxacintabs250mg/norfloxacintabs400mg 14. Glibenclamidetablets5mg 15. Nifedipineretardtablets20mg [B1]=SumofB [C1]=SumofC= = [B2]=%instock [C2]=%expired =B1÷15x100= =C1÷B1x100=

Notes [A] Thesamelistsof15keymedicinesusedforSurveyForm1preprintedonthesurveyforms. [B] Mark“1”ifanyquantityofanydosageformofthemedicineisinstockinthefacilityonthedayofthe visit.Mark“0”ifthemedicineisnotavailableinstock.Addthetotalatthebottom[B1].Calculatethe percentageinstock[B2]bydividingthetotalinstock[B1]by15andmultiplyingbothby100. [C] Forallmedicinesinstock,checkifanyofthestockisexpired.Ifanyamountofamedicinehasanexpiry problem,mark“1”foryes.Donotcountexpiredmedicinesstoredinaseparateareafordestruction.Add thetotalatthebottom[C1].Calculatethepercentageexpired[C2]bydividingthetotalexpired[C1]bythe totalnumberofmedicinesinstock[B1]andmultiplyingby100.

68 Central/districtwarehouse Facility#____(1Ͳ5) SurveyForm16:Central/regional/districtwarehousesupplyingthepublicsector Indicators:AveragestockͲoutduration Adequacyofrecordkeeping

Facility Date

Region Investigator Onlycollectdataformedicineswithrecordscoveringatleast6monthswithinthepast12months Recordscover Noofdays Equivalent Noof atleast6mths coveredby Noofdays Keymedicines days withinthepast thereview peryear totreatcommonconditions outof 12months (atleast6 [E]=Cx365÷ stock Yes=1,No=0 months) D [A] [B] [C] [D] [E] 1. ORS(newformula) 2. Amoxicillincaps250mg/500mg 3. Amoxicillinsusp125mg/5ml 4. Artemether/lumefantrine (20/120mg)tablets(anypack) 5. Ferroussalttablets(aloneorin combinationwithfolicacid) 6. Albendazole400mgtablets 7. Tetracyclineeyeointment1% 8. Povidoneiodine10%solution 9. Clotrimazolecream1% 10. Paracetamoltablets500mg 11. Paracetamol/syrupsuspension 120mg/5ml 12. Metronidazoletablets200mg 13. Ciprofloxacintabs 250mg/norfloxacintabs400mg 14. Glibenclamidetablets5mg 15. Nifedipineretardtablets20mg [B1]=SumofB [E1] = Sum of = E= [B2]=%adequate records=B1÷15 x100=

[F]=Averagenumberofstockoutdays=E1÷B1=

Notes

[A]Thelistof15keymedicinesandoptionaladditionalmedicinesidentifiedforSurveyForm 1shouldalsobepreprintedonthisform.

[B]Gothroughthestockcardsandindicatewhichmedicineshaverecordscoveringatleast6 monthswithintheprevious12months.Addthetotalatthebottom[B1].Calculatethe percentageofmedicineswithadequaterecords[B2]bydividingthenumberofmedicines withrecordscoveringatleast6months[B1]by15andmultiplyingby100.

[C]Thereviewshouldcover6Ͳ12months. Gothrough thestockcardscovering thereview period.Indicatethenumberofdayseachmedicinewasnotavailableormarked“0”on thecard.Amedicineisconsideredinstockifitisavailableingenericorbrandedform.

[D]Indicatethenumberofdaysactuallyreviewedforeachmedicine.

[E] Compute the equivalent number of stockout days per year for each medicine by multiplyingthenumberofdaysoutofstock[C]by365anddividingbythenumberofdays coveredbythereview[D].Addthetotalnumberofstockoutdays[E1].

[F] Calculatetheaveragenumberofstockoutdaysbydividingthetotalnumberofstockoutdays [E1]bythetotalnumberofkeymedicinesreviewed[B1].

Example: Recordscover Noofdays Equivalent Noof atleast6mths coveredby Noofdays Keymedicines days withinthepast thereview peryear totreatcommonconditions outof 12months (atleast6 [E]=Cx365÷ stock Yes=1,No=0 months) D [A] [B] [C] [D] [E] Cotrimoxazole 1 90 180 182.5 Paracetamol 1 30 365 30 Amoxicillin 0 [B1]=SumofB [E1] = Sum =2 ofE=212.5 [B2]=% adequate records=B1÷ 15x100=66.7 [F]=Averagenumberofstockoutdays=E1÷B1=106.25

70 SurveyForm17:Central/regional/districtwarehousesupplyingthepublicsector Indicator: Adequacyofconservationconditionsand Central/districtwarehouse handlingofmedicines Facility#____(1Ͳ5)

Facility Date

Region Investigator Storeroom Checklist True=1,False=0 [A] 1. Thereisamethodinplacetocontroltemperature(e.g.roof andceilingwithspacebetweentheminhotclimates,air conditioners,fans,etc) 2. Therearewindowsthatcanbeopenedorthereareairvents. 3. Directsunlightcannotenterthearea(e.g.windowpanesare paintedortherearecurtains/blindstoprotectagainstthesun) 4. Areaisfreefrommoisture(e.g.leakingceiling,roof,drains, taps,etc.). 5. Thereisacoldstorageinthefacility 6. Thereisaregularlyfilledtemperaturechartforthecoldstorage 7. Medicinesarenotstoreddirectlyonthefloor 8. Medicinesarestoredinasystematicway(e.g.alphabetical, pharmacological) 9. MedicinesarestoredfirstͲexpiryͲfirstout(FEFO) 10. Thereisnoevidenceofpestsinthearea [A1]=SumofA= [A2]=Score =A1÷10x100= Notes: [A] Indicate“1”ifallpartsofthestatementaretrueforthestoreroomand“0”ifanypartof itisfalse. Sumthetotalnumberoftruestatements[A1]. Calculatethescoreforthestoreroom[A2]bydividingthesumoftruestatements[A1]by 10andmultiplyingby100. *Itmaybenecessarytolookelsewhereinthefacilityforsomeofthecriteria(e.g. refrigerator)

71 ANNEX3:CHARACTERISTICSOFOUTPATIENTSINTERVIEWED No.of Categoryofhealth No. % outpatients Age No. % facility Female Female interviewed 1)under5yrs. 112 31.55 2)olderchildren 40 11.27 PublicHospital 355 213 60.00 3)adults 188 52.96 4)over60yrs 15 4.23 1)under5yrs. 69 29.74 2)olderchildren 44 18.97 PublicHealthCenter 232 140 60.34 3)adults 112 48.28 4)over60yrs 10 4.31 1)under5yrs. 174 40.66 2)olderchildren 79 18.37 PublicDispensary 430 216 50.23 3)adults 154 35.81 4)over60yrs 23 5.34 1)under5yrs. 85 22.02 2)olderchildren 72 18.65 FBHSHospital 386 220 56.99 3)adults 227 58.81 4)over60yrs 32 8.29 1)under5yrs. 32 30.77 2)olderchildren 17 16.35 FBHSHealthCentre 104 62 59.61 3)adults 44 42.31 4)over60yrs 11 10.58 1)under5yrs. 109 26.52 2)olderchildren 71 17.27 FBHSDispensary 411 230 55.96 3)adults 207 50.36 4)over60yrs 24 5.84 1)under5yrs. 154 16.74 2)olderchildren 109 11.85 PrivatePharmacy 920 450 48.91 3)adults 574 62.39 4)over60yrs 70 7.61 1)under5yrs. 735 25.59 2)olderchildren 432 15.12 Totals 2838 1531 53.95 3)adults 1506 53.06 4)over60yrs 185 6.21

72 ANNEX4:LISTOFDATACOLLECTORS

Name Designation 1 Dr.CarolineOlwande Pharmacist 2 Dr.OduorOnyango Pharmacist 3 Dr.HadleySultani Pharmacist 4 Dr.StanleyNdwiga Pharmacist 5 Dr.MarsellahOgendo Pharmacist 6 Dr.TracyNjonjo Pharmacist 7 Dr.NewtonAngawa Pharmacist 8 OmarFarahIbrahim PharmTech 9 AliS.Kidzuga PharmTech 10 RoseMakenaKiunga PharmTech 11 AbdullahiAbdikadir PharmTech 12 Dr.JuliaKimondoW Pharmacistintern 13 Dr.AlexMuchugia Pharmacistintern 14 Dr.MarkMakomereNduku Pharmacistintern 15 Dr.FaithRizikiMjambili Pharmacistintern 16 Dr.NancyW.Njuguna Pharmacistintern 17 Dr.WinnieNganga Pharmacistintern 18 GraceM.Komen PharmTech 19 MainaP.Njuguna PharmTech 20 IbrahimO.Mokaya PharmTech 21 JamesKariukiThuo PharmTech 22 AndrewM.Kairu PharmTech 23 SolomonK.Koech PharmTech 24 K.YussufHassan PharmTech 25 JosephM.Mutungi PharmTech 26 GideonK.Too PharmTech

73 ANNEX5:LISTOFSAMPLEDHEALTHFACILITIES

Table1:ListofGovernmentFacilities Health Otherdispensing Province LargestHospital OtherHospital Centre outlets EastleighHC KenyattaNational Nairobi MbagathiDH RuaiHC HurumaLionsDisp Hospital LowerKabeteDisp TinetDisp RiftͲValley NakuruPGH ChemolingotSDH NairageHC NgamboDisp NaiborAjikjikDisp AnyuongiDisp Nyanza NyanzaPGH BondoDH KabondoHC NduruKaderoDisp KokwanyoDisp BudutaDisp Western KakamegaPGH SirisiaSDH SioPortHC EshikuyuDisp MihuuDisp RailwaysDisp Coast CoastPGH KilifiDH GarsenHC MbalambalaDisp MirihiniDisp KhalalioDisp NorthEastern GarissaPGH WajirDH HulughoHC TarbajDisp SakaDisp

Table2:ListofFBHSFacilities Province FacilityName District KagSomboDispensary Garissa KhadijaMosqueDispensary Mandera NORTH EASTERN ElwakMHCClinic Mandera WajirAICDispensary Wajir WajirCatholicDispensary Wajir KenduHospital Rachuonyo MatataNursingHome Rachuonyo LwakͲSt.ElizabethHospital Bondo NYANZA NyamonyeCatholicDispensary Bondo BoloͲSt.ClareDispensary Kisumu St.Monicah'Hospital Kisumu ChonyiͲSt.TheresaDispensary Kilifi WemaDispensary Tana EmmausDispensary TanaRiver COAST ZionCommunityDispensary Mombasa MaryImmaculateCottageHosp Mombasa MewaMedicalCentre Mombasa NambobotoMissionDispͲACK Busia NanginaHolyFamilyHospital Busia KalachaAICDispensary Kakamega WESTERN MusoliStPiusDispensary Kakamega FriendsLuguluMissionHosp. Bungoma StDamianoMedicalCentre Bungoma St.Mary'sCatholicHospital Nakuru NjoroPceaHealthCentre Nakuru KapeddoMissionHospital Baringo RIFTVALLEY MarigatCatholicMissionClinic Baringo SiyiapeiAicDispensary Narok NaikarraHealthCentreͲAGC Narok StMary'sMissionHospitalͲNRB Nairobi GoodPeopleWorldFamilyClinic Nairobi St.AngelaDispensary Nairobi NAIROBI MukuruMaryImmaculateClinic Nairobi KorogochoHealthCentreͲRGC Nairobi BuruburuFriendsChurchClinic Nairobi

Table3:Facilitiessampledbutnotsurveyedduringfieldwork

Reasonsfor Province FacilityName District Alternativefacility substituting Ashabito Mandera Areainsecure KhalalioDispensary Dispensary KAGSomboDisp. Garissa Couldnotbetraced AlͲFaroukdispensary TowbaMedical Couldnotbetraced AICDispensaryͲGarissa Care Garissa NORTH KhadijaMosque Institutionalfacilityina EASTERN SimahuMissionHospital dispensary Mandera girl’sschool. YoungMuslim ElwakMHCClinic Mandera Couldnotbetraced Dispensary WajirCatholic Inadequateno.of Wajir SDAMissionHospital Dispensary interviewees St.JosephNyabondo Mission(Kisumu MatataNursing Foundtobeaprivate Rachuonyo District)sampledsince Home facility NYANZA nootherfacilitiesin Rachuonyo BoloͲSt.Clare Inadequateno.of Kisumu AwasiCatholicMission Dispensary interviewees DistrictHealth Emmaus TanaRiver ManagementTeam St.RaphaelDispensary Dispensary COAST unawareofitsexistence. Mbalambala Facilityinaccessibledue TanaRiver PumwaniDispensary Dispensary tosecurityreasons. ClosedfollowingpostͲ RIFTVALLEY TinetDispensary Nakuru NjoroHealthCentre electionviolence GoodPeopleWorld CopticHospitalͲNgong NAIROBI Nairobi Couldnotbetraced. FamilyClinic Road Namboboto Inadequateno.of ButulaMissionHealth Busia MissionDispͲAck interviewees Center KalachaAic Inadequateno.of Kakamega St.ElizabethMukumu Dispensary interviewees WESTERN Unabletolocateitand MusoliStPius DistrictHealth Kakamega St.Mary'sMumias Dispensary ManagementTeam unawareofitsexistence.

76 ANNEX6:BASIC(CORE)MEDICINESLIST(COUNTRYLIST) 1. ORS(newformula) 2. Amoxicillincapsules250mg/500mg 3. Amoxicillinsuspension125mg/5ml 4. Artemether/lumefantrine(20/120mg)tablets(anypack) 5. Ferroussalttablets(aloneorincombinationwithfolicacid) 6. Albendazole400mgtablets 7. Tetracyclineeyeointment1% 8. Povidoneiodine10%solution 9. Clotrimazolecream1% 10. Paracetamoltablets500mg 11. Paracetamol/syrupsuspension120mg/5ml 12. Metronidazoletablets200mg 13. Ciprofloxacintabs250mg/norfloxacintabs400mg 14. Glibenclamidetablets5mg 15. Nifedipineretardtablets20mg ANNEX7:MMEPAMEDICINESLIST Thislistwasusedtogathermedicinesdatafordeterminationofavailabilityandaffordabilityindicators: 1. Aciclovirtab200mg 2. Amitriptylinetab25mg 3. Amodiaquinetab200mg 4. Amoxicillinsusp125mg/5mL 5. Amoxicillincap/tab250mg 6. Amoxicillin/clavulanicsusp125/31mg/mL 7. Amoxicillin/clavulanictab500/125mg 8. Artemether/lumefantrinetab20/120mg 9. Atenololtab50mg 10. Beclomethasoneinhaler50mcg/dose 11. Carbamazepinetab200mg 12. Ceftriaxoneinj250gpowder 13. Ciprofloxacintab250mg 14. Clotrimazolecream/oint15%w/v 15. CoͲtrimoxazolepaedsusp8/40mg/mL 16. CoͲtrimoxazoletab80/400mg 17. Diclofenactab25mg 18. FerrousSulfate/FolicAcidcombinationtab200mg/400mcg 19. Fluconazolecap/tab200mg 20. Fluphenazineinj25mg/ml 21. Furosemidetab40mg 22. Glibenclamidetab5mg 23. Ibuprofentab200mg 24. Insulinhuman30/70injection 25. Lamividine/stavudine/nevirapinetab3TC/d4T/NVP150/40/200mg 26. Metformintab500mg 27. Nifedipineretard20mg 28. Omeprazolecap20mg 29. ORS(newWHOformula)sachetfor500mL 30. Oxytocininj5IU/mL 31. Phenytoincap100mg 32. Pyrimethamine/sulfadoxine25/500mg 33. Quininedihydrochlorideinj300mg/mL 34. Ranitidinetab150mg 35. Salbutamolinhaler0.1mg/dose 36. Zidovudine(AZT)/lamivudine(3TC)tab300/150mg 77 REFERENCES

1. NormsandStandardsforHealthServiceDelivery,MinistryofHealth,Kenya,June2006 2. Assessment of the pharmaceutical situation in Kenya: a baseline survey, Ministry of Health/WHO/HAI,2003 3. Kenya National Pharmaceutical Policy (KNPP), Ministry of Medical Services/Ministry of PublicHealth,201046 4. PricecomponentsandessentialmedicinesinNairobi,Kenya,MinistryofHealth,WHOand HealthActionInternationalͲAfrica;2007(unpublisheddraft) 5. WHO Operational Package for Assessing, Monitoring and Evaluating Country PharmaceuticalSituations:GuideforCoordinatorsandDataCollectors.WHO/TCM/2007.2 (includesLevel1AssessmentQuestionnaire) 6. Usingindicatorstomeasurecountrypharmaceuticalsituations:FactBookonWHOLevelI andLevelIImonitoringindicators.WHO/TCM/2006.2 7. Resultsfromothercountriescanbefoundintheabovedocument,inWHOcountryͲspecific reports,andperiodicallyinjournals,suchastheBulletinoftheWorldHealthOrganization.

46Expecteddateofpublication

78 GLOSSARY

Healthy Life Expectancy at Birth (HALE): aka Disability Adjusted Life Expectancy is a WHO summary measure of the level of health that captures the full health experience of the population, and not just mortality. It is a measure of life expectancy adjusted for nonͲfatal outcomes,andisusedtoassesshealthsystemsperformance.Itismosteasilyunderstoodas thelifespaninfullhealth,i.e.withoutdisability. (seehttp://www.euro.who.int/document/ehr/e76907d.pdfor http://www.who.int/healthinfo/statistics/indhale/en/formoredetails) Median:Inaseriesofnumbers,themedianisthevalueinthemiddleofthedistribution.Halfof therespondingfacilitieswouldhavereportedvaluesbelowthemedian,andhalfavalueabove themedian.Similarly,the25thand75thpercentilesarethevaluesreportedby25and75per centofthefacilities,respectively Medicines: this term has generally superseded the term ‘drugs’ in current health and particularlypharmaceuticaldocuments.Inthisreportthetermisgenerallyusedinabroader sensetoincludeotherhealthconsumableitems(i.e.thanjustpharmaceuticals),alsoknownas medicalsuppliesorhealthsupplies,whichmayberequiredforprovisionofhealthservices,e.g. dressings,syringes,needles,diagnosticconsumables,etc. Pharmaceuticals: these are the specifically drugͲrelated items used in provision of health services which are presented and administered in various doseͲforms, e.g. tablets, capsules, injections,creams,etc.Thetermisoftenusedsynonymouslywiththetermmedicinesinmany healthͲrelateddocuments. Public(health)sector:TheGovernmentSectorwhichismanagedprimarilyandjointlybythe Ministry of Public Health and the Ministry of Medical Services. This sector also includes a number of health facilities under the authority/responsibility of the Ministry of Local Government and other public sector bodies such as the Army, Police, Prisons and national parastatals.

79 Ministry of Medical Ministry of Public Health Services and Sanitation