Monitoring the Quality of Antimalarial Medicines … PMS...Executive Summary Malaria still accounts...

PPB/MIP/PMS/RPT/02/16-17

MINISTRYOFHEALTH

PharmacyandPoisonsBoardandNationalMalariaControlProgram

MonitoringtheQualityofAntimalarialMedicines

CirculatinginKenya:Round5

July2017

PPB/MIP/PMS/RPT/02/16-17

i

Pharmacy&PoisonsBoard,

Kenya

MonitoringtheQualityofAntimalarialMedicinesCirculatingin

Kenya:Round5

RevisionNo.0

PPB/MIP/PMS/RPT/02/16-17 Preparedby

QAO

Sign…………….…

Date……………….

Checkedby

D/MIP

Sign……………

Date……………

Checkedby

HQMS

Sign…………..

Date…………..

Authorizedby

REG

Sign……………….

Date……………….

Thisdocument ismadepossiblebythegeneroussupportoftheAmericanpeoplethroughtheU.S.Agency for International Development (USAID), under the terms of associate award cooperativeagreementnumberAID-623-LA-11-00008.

ThecontentsaretheresponsibilityoftheMinistryofHealth,anddonotnecessarilyreflecttheviewsofUSAIDortheUnitedStatesGovernment.

ThePostMarketingSurveillanceexercisewasconductedwiththesupportoftheGlobalFundtofightAIDS,TuberculosisandMalaria&USAID,President’sMalariaInitiative(PMI)throughUSPPQM.

RecommendedCitation

MinistryofHealth,Kenya.MonitoringtheQualityofAntimalarialMedicinesCirculatinginKenya–Round5.June2017

Enquiriesregardingthisdocumentshouldbeaddressedto:

TheRegistrar,

PharmacyandPoisonsBoard,

MinistryofHealth,

P.O.BOX27663-00506

Nairobi,Kenya.

Telephone:+254202716905/6,3562107

Cellphone:0733884411/0720608811

E-mail:[email protected],[email protected]

Website:http://pharmacyboardkenya.org

ii

Acknowledgements

This report presents the findings froma collaborative studybetween theMalaria ControlUnit(MCU),thePharmacyandPoisonsBoard(PPB),theNationalQualityControlLab(NQCL)andtheUnitedStatesPharmacopoeiaPromotingtheQualityofMedicines(PQM)program.Funding for this study was provided by The Global Fund to Fight AIDS, Tuberculosis andMalariaround4grantnumberKEN-405-G06-MandU.S.President’sMalariaInitiative/USAIDthrough the United States Pharmacopoeia, Promoting Quality of Medicines. The USAID-fundedHealth Commodities and ServicesManagement (HCSM) program implemented byManagementSciencesforHealth(MSH)providedtechnicalassistanceintheanalysisofdataandcompilationofthefinalreport.

The authors of this report would also like to thank the Registrar and Deputy RegistrarPharmacyandPoisonsBoard,theDirectorNQCL,theheadoftheMCUandstafffromMSH/HCSMforfacilitatingthisnobleactivity.

The invaluable contribution of the data and sample collection team (annex 7.2) isacknowledged.Finally,thefollowingmembersarerecognizedfortheirparticipationindataanalysisandreportwriting:

- DrWelbyChimwami: ProgramManager–MOH/NMCP1

- DrEdwardAbwao: MemberMIPV,PPB

- DrChristabelKhaemba: MemberMIPV,PPB

- DrStephenKimathi: Director,MIPV,PPB

- DrMarthaMandale: MemberMIPV,PPB

- DrChrisMasila:ConsultantUSP-PQMProgram

- DrLatifahEl-Hadri:SeniorProgramManager-USPPQMProgram

1NMCP=NationalMalariaControlProgram

iii

ExecutiveSummary

Malaria still accounts for themost number of deaths and outpatient visits in the Kenyanhealthcare system.Malaria isa significantpublichealthproblem inKenya.More than70percentofthepopulationliveinmalariariskareas,includingthosemostvulnerabletothedisease:childrenandpregnantwomen(MalariaIndicatorSurvey2015).Availabilityofgoodquality medicines is essential in ensuring prompt and effective treatment of malariaaccordingtothecurrentnationalmalariastrategy.

11 sites participated in theminilab testing of antimalarialmedicines during this round ofactivity. Each of the eleven sites screened 80 samples of anti-malarials bought or pickedfrombothprivateandpublichealthfacilitiesandchemistsintheirsurroundingsites.

Due to the increased number of sentinel site, sample collection and field-testing of themedicinestookplacebetween24thAugust2014and19thSeptember2014.Theelevensitesweredividedintotwowiththefirstfiveteamscarryingouttheactivitybetween25thAugustto5thSeptember2014andthesecondgroupofsixteamscarryingouttheactivitybetween8thand19thSeptember2014

Availability of good quality medicines is essential in ensuring prompt and effectivetreatmentofmalariaaccordingtothecurrentnationalmalariastrategy.Thisreportpresentsthefindingsofthefifthroundandalsocomparestheresultsobtained inthefirst,second,thirdandfourthandfourthroundsofmonitoringofthequalityofanti-malarialsthathavebeendoneoverthelastfiveyears.

Eightyantimalarialsamplesweretargetedineachoftheelevensentinelsites.Thepurposivesampling of anti-malarials included artemisinin-based combination therapy (ACT) andSulfadoxine-Pyrimethamine (SPs), amongothers, basedon their availability. Samplingwasdoneinthepublic,privateandinformalsectors.

BasictestingusingtheGlobalPharmaHealthFund(GPHF)MinilabTMwasperformedonthecollectedsamplesat thesentinel sites.Thiswas followedbyanalysisof10percentof thesamples that passed minilab analysis, all doubtful samples and all failed samples at theNational Quality Control Laboratory (NQCL) or at Missions for Essential Medicines andSupplies(MEDS).

Theresultsindicatethatthepresenceofunregisteredandsubstandardanti-malarialsinthemarkethasreducedovertimeas100%ofsamplescollectedwereregisteredwithPharmacyandPoisonsBoard (PPB).99.3%ofall thesamplescollectedduring the round fiveactivitywere found tobe registeredbyPPB.For thesamples thatunderwentcompendial testing,90.24%passed.

The results indicate that ACTs in the public, private and informal sectors were of goodquality.Theresultsalsoshowtheconvenienceofutilizingminilabsasasafe,rapidandcost-effectivewayofscreeninganti-malarialmedicinesinthefield.

iv

AcronymsandAbbreviations

ACTm Artemisinine-basedCombinationTherapyformalaria

AL ArtemetherLumefantrine

AMFm AffordableMedicinesforMalaria

HCSM HealthCommoditiesandServicesManagement

MCU MalariaControlUnit

MSH ManagementSciencesforHealth

MIP

NMCP

MedicinesInformationandPharmacovigilance

NationalMalariaControlProgram

NQCL NationalQualityControlLaboratory

PMS PostMarketSurveillance

PQM PromotingtheQualityofMedicines

PPB PharmacyandPoisonsBoard

TLC Thin-LayerChromatography

USAID UnitedStatesAgencyforInternationalDevelopment

USP UnitedStatesPharmacopeia

USP-NF UnitedStatesPharmacopeia-NationalFormulary

USPPQM UnitedStatesPharmacopeia-PromotingQualityofMedicines

v

TableofContents

Acknowledgements................................................................................................................................ii

ExecutiveSummary...............................................................................................................................iii

AcronymsandAbbreviations................................................................................................................iv

TableofContents...................................................................................................................................v

1. INTRODUCTION...................................................................................................................................1

1.1. MalariainKenya.......................................................................................................................1

SitesofRoundFiveActivity................................................................................................................2

�SentineltestingSiteSelection............................................................................................................3

2.OBJECTIVE..........................................................................................................................................4

1.2. QualityofAntiMalarialsinKenya............................................................................................4

1.3. AimsandObjectives.................................................................................................................5

2. METHODOLOGY..................................................................................................................................6

2.1. SamplingStrategyandTraining................................................................................................6

2.2. SiteSelection............................................................................................................................6

2.3. MedicinesSelectedforSampling.............................................................................................6

2.4. SampleDefinition.....................................................................................................................7

2.5. NumberofUnitstoCollectperSample....................................................................................7

2.6. CriteriaforPrioritizationofSampling.......................................................................................8

2.7. CriteriaforDiversificationofSampling....................................................................................8

2.8. SampleCollection.....................................................................................................................8

2.9. SampleAnalysis........................................................................................................................9

2.9.1. Level1BasicTestsutilizingtheMinilabsatSentinelSite..................................................9

2.9.2. Level2:VerificationofBasicTestsatNQCL....................................................................10

2.9.3. Level3:ConfirmatoryTestingwithCompendialMethodsatNQCL................................10

3. RESULTS..........................................................................................................................................11

3.1. SampleDescription................................................................................................................11

3.1.1. SamplingbySector..........................................................................................................11

3.1.2. SamplingbyAPI...............................................................................................................11

3.1.3. SamplingbyRegion.........................................................................................................12

3.1.4. SummaryofSampling......................................................................................................12

3.2. RegistrationwiththePharmacyandPoisonsBoard..............................................................12

3.3. BasicandCompendialTestResults........................................................................................13

vi

3.3.1. Level1ScreeningTestResults.........................................................................................13


3.3.3. Level3CompedialTestResults.......................................................................................13

4. DISCUSSION......................................................................................................................................14

4.1. SampleDescription................................................................................................................14

4.1.1. SamplingbySector..........................................................................................................14

4.1.2. SamplingbyAPI...............................................................................................................14

4.1.3. SamplingbyRegion.........................................................................................................15

4.1.4. SummaryofSampling......................................................................................................16

4.2. RegistrationwiththePharmacyandPoisonsBoard..............................................................16

4.3. BasicandCompendialTestResults........................................................................................17



4.3.3. Level3CompedialTestResults.......................................................................................19

4.4. DeterminantsofConformity..................................................................................................19

4.4.1. SectorofHealth...............................................................................................................19

4.5. RegistrationStatus.................................................................................................................20

4.6. ScreeningandCompedialTestResults...................................................................................20

4.7. RegulatoryActionsUndertakenbyPPB.................................................................................21

5. CONCLUSIONANDRECOMMENDATIONS................................................................................................21

5.1. Conclusion..............................................................................................................................21

5.2. Recommendations.................................................................................................................21

6. REFERENCES.....................................................................................................................................23

7. ANNEXES.........................................................................................................................................24

7.1. SamplingChecklist..................................................................................................................24

7.2. SampleCollectionForm.........................................................................................................25

7.3. BasicTestsAnalysisFormforSentinelSiteStaff....................................................................26

7.4. BasicTestsAnalysisFormforNationalQualityControlLaboratoryStaff...............................28

7.5. ListofSampledFacilities........................................................................................................30

7.6. ListofData/SampleCollectionTeam....................................................................................38

1

1. INTRODUCTION

Malariaisaglobalhealthproblem.TheWorldHealthOrganization(WHO)estimatesthat3.2billion people are at risk of malaria worldwide. Sub-Saharan Africa is disproportionallyaffected; in 2015, the regionhad88%ofmalaria cases and90%ofmalaria deaths (WHO2016).InKenya,malariaremainsamajorcauseofmorbidityandmortalitywithmorethan70%ofthepopulationatriskofthedisease(MOH2014).

1.1. MalariainKenya

ThemalariaburdeninKenyaisnothomogenous.TheareasaroundLakeVictoriaandonthecoastpresentthehighestrisk,andchildrenunderage5andpregnantwomenarethemostvulnerable to infection. In the last 5 years, there has been overall reduction in malariaprevalence inKenyaascomparedwiththe2010.Thecurrentmalariaprevalentrate is8%(KenyaMalariaIndicatorSurvey(KMIS)2015)

Malaria transmission and infection risk in Kenya is determined largely by altitude, rainfallpatternsandtemperature.Therefore,malariaprevalencevariesconsiderablybyseasonandacross geographic regions. The variations in altitude and terrain create contrasts in thecountry’sclimate,whichrangesfromtropicalalongthecoasttotemperateintheinteriortoverydryinthenorthandnortheast.Therearetworainyseasons—thelongrainsoccurfromApriltoJuneandtheshortrainsfromOctobertoDecember.ThehighesttemperaturesarefromFebruarytoMarchandthelowestfromJulytoAugust.

The 2015 KMIS results indicate thatmuch progress has beenmade inmalaria control inKenya.Tosustainthegains,investmentlevelsneedtobemaintained,especiallyinthehighburdenareasaroundLakeVictoriaandinthecoastalregion.

The majority of the at-risk population (17 million people) live in areas of epidemic andseasonalmalaria transmissionwhereP. falciparumparasiteprevalence isusually less than5%. For the purposes of malaria control, the country has been stratified into fourepidemiologicalzonestoaddressthevariedrisks:

• Endemicareas:Theseareasofstablemalariahavealtitudesrangingfrom0to1,300meters around Lake Victoria in western Kenya and in the coastal regions of thecountry.Transmissionisintensethroughouttheyear.Thevectorlifecycleisusuallyshortwithahigh survival ratedue to the suitable climatic conditions. Themalariaprevalencerateis27%intheendemicregion(KMIS2015).

• Highland epidemic-prone areas:Malaria transmission in the western highlands isseasonal with considerable year-to-year variation. The whole population isvulnerable,andcasefatalityratesduringanepidemiccanbeupto10timesgreaterthanwhatisexperiencedinregionswheremalariaoccursregularly.Herethemalariaprevalencerateis3%

• Semi- arid, seasonal malaria transmission areas: This epidemiological zonecomprises of arid and semi- arid areas of northern and southeastern parts of the

2

countrywhichexperience shortperiodsof intensemalaria transmissionduring therainyseasonstheaveragemalariaprevalencerateislessthan1%.Temperaturesareusually high, andwater pools createdduring the rainy seasonprovide themalariavectorswithbreedingsites.ExtremeclimaticconditionssuchastheElNiñosouthernoscillationleadtofloodingintheseareas,resultinginepidemicoutbreakswithhighmorbidityratesduetothepopulation’slowimmunestatus

• Lowmalaria risk areas: This zone covers the central highlands of Kenya includingNairobi. Temperatures are usually too low to allow completion of the sporogoniccycle of themalaria parasite in the vector. However, increasing temperatures andchanges in the hydrological cycle associated with climate change are likely toincrease the areas suitable for malaria vector breeding and introduce malariatransmissioninareaswhereitdidnotpreviouslyexist.

SitesofRoundFiveActivity

KajiadoCountyislocatedinSouthriftvalleyregionofKenya.ItbordersNaroktothenorth,Nairobitotheeast,TanzaniatothesouthandTavetatothewest.ThepopulationislargelycosmopolitanwiththeMaasaibeingthepredominantcommunitywhohavestrongculturalbeliefs.Thecountyhasapopulationofapproximately510,000people.Womenandchildrenaccount for65%of thispopulationandaremost vulnerable tomalaria. Thepopulation islargelycosmopolitanwiththeMaasaibeingthepredominantcommunitywhohavestrongculturalbeliefs.MalariaisprevalentinthesouthwestregionsofKajiado.

KisiiCountyisacountyintheWesternPartofKenyaintheformerNyanzaprovince.Ithasatotalpopulationof1,152,282;245,029Householdsandcoversanareaof1,317.4km2.Thepopulationdensity874.7peopleperkm2and51%ofthepopulationlivebelowthepovertyline.

NyamiraCounty is a county in theNyanzaProvinceofKenya. Ithasa totalPopulationof598,252;131,039Householdsandcoversanareaof899.3km2.ThePopulationdensity665peoplekm2and46.6%ofthepopulationlivebelowthepovertyline.TheteamherecoveredKisiiandNyamiracounties,withinNyanzaregioninwesternKenya.Thesetwocountieshaveacumulativepopulationof1.75millionaccordingtothe2009populationcensus.

KerichoCountyisfoundinRiftValleyprovinceandthepopulationin2013wasestimatedat849,032 and is expected to be about 970,930 in the year 2017. The number ofmales isestimatedat416,026andthenumberoffemalesisestimatedat433,006,whichisaratioof49:51. It measures about 2,479 km2. The County has 6 sub counties: Belgut, Ainamoi,KipkelionEast,KipkelionWest,Bureti,Sigowet/Soin

MigoriCountyisfoundintheformerNyanzaProvinceofsouthwesternKenya.ItscapitalisMigori,whichisitslargesttown.Thecountyhasapopulationof1,098,343.Ithasanareaof2,586km².MigoriCountyhas8constituencies(Awendo,Rongo,SunaEast,SunaWest,Uriri,NyatikeandKuriaEastandKuriaWest.)

3

Mombasa County is located in Coast province and constitutes 6 constituencies(Changamwe,Jomvu,Kisauni,Nyali,LikoniandMvita).Mombasaisalsoaportcitywhereamajority of imports to Kenya comes through. This also includes medicines and medicalequipment.TheportcityalsohandlesimportsforEastandCentralAfrica.

UasinGishuCounty is located in theRiftValleyprovinceandconstitutes6 constituencies(Soy, Turbo,Moiben,Ainabkoi, Kapseret, Kesses). Its headquarters is Eldoret town,whichhasanumberofmedical facilities,notablyMoiTeaching&ReferralHospital,UasinGishuDistrict Hospital, Eldoret Hospital,Mediheal Hospital, Elgon View Hospital among others.Eldoretalsohasthethirdbiggestairportinthecountyandanumberofimportscomeintothecountrythroughtheairport.

�SentineltestingSiteSelection

Each of the 11 teams selected a site to carry out the minilab testing of the collectedsamples.Thetestingsiteswereselectedbasedon;availabilityofelectricity,runningwater,secure storage space and enough workspace. In addition, the manager of the site wasrequiredtoapprovethesitebeingusedfortesting.Theelevensitesselectedfortheactivitywereeithermalariaproneareasorportsofentryoracombinationofboth.Thetablebelowgivesthesummary

No. PortofEntry County Criteriaforselection

1. Namanga Kajiado Portofentry2. Isebania Migori Portofentry/EndemicZone3. Vanga Kwale Portofentry/EndemicZone4. Busia Busia Portofentry/EndemicZone5. Nairobi(JKIA,Wilson

airports)Nairobi Portofentry(MostmedicinestoKenyacomein

throughNairobibyAir.It’sthebiggestsourceofmedicinestotheotherpartsofthecountryandtheregion)

6. Eldoret(MoiAirport) Eldoret Portofentry(AnalternateportofentryformedicinescomingintoKenyabyair)

7. Mombasa(SeaPort) Mombasa Portofentry(AllmedicinesthatcometoKenyaandtheregionbySeacomeinthroughMombasa)

8. Kisii EpidemicZone9. Kericho EpidemicZone10. Kakamega EndemicZone11. Kisumu EndemicZoneTable1Summaryoftheminilabsites

4

Figure1Kenyacounties

2.OBJECTIVE

Goodqualitymedicineisapre-requisiteforpromptandeffectivetreatmentofmalaria.PostMarket-Surveillance(PMS)istheregularsamplingandtestingofmedicinesafterregistrationandpresenceoftheproductinthemarket.

Theobjectiveswere:

i. Tomonitorthequalityandregistrationstatusofantimalarialsinthecountry.ii. To monitor the safety of medicines and conformity with the established

specificationsforqualityasdeclaredintherecognizedpharmacopoeiaspecifications.iii. To determine the proportion of antimalarials in Kenya that conforms to quality

standards.

1.2. QualityofAntiMalarialsinKenya

SeveralstudiestoassessthequalityofantimalarialsinKenyahavebeenundertakeninthelastdecadeandcontinuetoinformcurrentandfutureinitiativestowardsacomprehensivepost –marketing surveillance (PMS) system. Themain findings of some of these previousstudiesinclude:

5

- In 2008, PPB and DOMC collaborated in a multi-country study on quality of anti-malarialsinAfrica(QAMSA).Resultsfromthestudyshowedthat96%ofthe44samplescollected from Kenya fully conformed to quality specifications. Only two of 24 ACTsamples tested failed (both on limit tests for presence of impurities), and allSulfadoxine/Pyrimethaminesampleswerecompliantwithspecifications(WHO,2010).

- In 2010, a nationwide survey of anti-malarials by the PPB and Malaria Control Unit(MCU) found that 93% of the 535 samples collected were registered in the country;91.8%,(n=451),76.3%(n=80)and84.1%(n=44)ofthesamplesanalyzedpassedLevel1,Level2andLevel3analysisrespectively.

- In 2011, another nationwide survey of anti-malarials by the PPB andMalaria ControlUnit (MCU) found that 96.8% of the 499 samples collected were registered in thecountry; 97%, (n=496), 100% (n=65) and 76% (n=25) of the samples analyzed passedLevel1,Level2andLevel3analysisrespectively.

- In 2012 the round three of the monitoring quality of medicines for antimalarialsconducted by the PPB and MCU in 2012, showed that 99.1% of the 545 samplescollectedwereregisteredinthecountry;94.6%,(n=514),90%(n=71)and90%(n=20)ofthesamplesanalyzedpassedLevel1,Level2andLevel3analysisrespectively.

- Roundfourofthemonitoringqualityofmedicinesforantimalarialscarriedoutin2014showed that that 99.3%of the 606 samples collectedwere registered in the country;82%, (n=606), and100% (n=115) of the samples analyzedpassed Level 1, and Level 3analysisrespectively.

1.3. AimsandObjectives

The primary objective of the post marketing surveillance is to monitor the safety ofmedicines and their conformity with the specifications for quality declared in theregistration dossier or recognized in the pharmacopeias. When conducted regularly, thisexercisehelpsprovidecontinuousinformationonthequalityofmedicinescirculatinginthecountry.

ThespecificobjectivesofthePMSexercisewere:

a) Toidentifyunregisteredproductsintheselectedsites

b) Todeterminethequalityofmedicinesintheselectedsites

c) Todevelopamedicine’squalitydatabase,fortrendanalysisofcirculatingmedicines

d) Disseminateinformationonmedicines’qualitytostakeholdersinvolvedinmedicinesprocurement,use,andregulation

e) Provideevidence-baseddataforenforcementactions

6

2. METHODOLOGY

2.1. SamplingStrategyandTraining

The sampling strategy involved collecting samples from various levels operating in thedistribution chain, including public sector facilities Kenya Medical Supplies Authority(KEMSA, public health facilities, health centers), non-governmental organizations (NGOs),faith-basedorganizations (suchasMissionofEssentialMedicinesServices (MEDS),privatefor-profits dispensing sites (pharmacies), hospitals (private and public), and the illicit(informal)markets.

Samples in the private sector were collected using the “mystery shopper” approach, toavoidalertingtradersbysimulatingthereallifesituationofhowpatientsaccessmedicines.

Thisstrategyensuredthatsampleswereobtainedfromallsectorswherepatientsaremostlikelytobeexposedtomedicines.

Theparticipantsweretrainedbeforethesamplingandtestingwascarriedout.MonitoringQualityofMedicines(MQM)facilitatedthetrainingwithsupportfromtheMalariaControlUnit(MCU),PPBandNQCL.

Sector SamplingLocation No.ofSamples TotalNo.ofSamples

Public CountyStore 3 15PublicHospital/FBO 6HealthCentre/Dispensary 6

Private Importer/Distributor/Wholesaler 9 42Retailers 18PrivateHospital 9Clinics 6

Informal Kiosks/Supermarkets 3 3Total 60

2.2. SiteSelection

SitesforsamplecollectionwereidentifiedincollaborationwithPPB,NMCP,NQCLandPQMbasedon several factors suchasepidemiologicaldata showingprevalenceof thedisease,medicinesavailabilityandaccessibility,freelycirculatingmedicinesoriginatingfrombordertowns,portsofentry,refugeecampsandavailabilityofhumanresources.

2.3. MedicinesSelectedforSampling

The selection of antimalarial medicines for sampling was based on MCU’s nationaltreatmentguidelinesandtheavailabilityofmonographsforanalysis.Theyincludefirst-linetreatment, second-line treatment, intermittent preventive treatment (IPT) for malaria inpregnantwomen,chemoprophylaxis,andtreatmentforseveremalaria.

• First-linetreatment

7

o ArtemetherLumefantrine(AL)• Second-linetreatment

o Dihydroartemesinin&Piperaquine(DHAP)• Severemalaria

o Parenteralquinineo Oralquinineo Artemether/Artesunateinjectiono RectalArtesunate

• IntermittentPreventiveTreatment(IPT)o Sulphadoxine&Pyrimethamine(SP)

• Chemoprophylaxiso Doxycyclineo Atovaquone/Proguanil

• OtherACTso ArtesunateAmodiaquine

• Monotherapieso Monotherapieswerenottested;theywerecollectedonlyforthepurposeof

monitoring the shift from monotherapies to ACTs and to evaluate theiravailabilityinthemarket.

2.4. SampleDefinition

Forthepurposeofthisstudy,asamplewasdefinedasamedicinecontainingadefinedAPI,dosage form, strength, and lot number from a particular level in the distribution chain.Samples with the same attributes described above and the same lot number were onlycollectediftheywerefoundinadifferentlevelinthedistributionchain,suchaswholesalerversusretailer,etc.Medicineswiththesamelotnumberwerenotcollectedfromsimilarorsamelevelfacilities(forexample,twopharmaciesorretailers).

2.5. NumberofUnitstoCollectperSample

The number of units collected per sample was determined by the required tests to beperformedonthesamples.Refertotablebelow.

Thefollowingexampleofsamplecollectionappliesonlytosoliddosageforms(tabletsandcapsules).

MinimumUnits MaximumUnits Comments

InitialSampling20 40 Iftheminimumof20unitsisnotfeasible,collectwhat

isavailablebutnolessthan5unitsRe-SamplingforCompedialTesting

50 100 Ifthe―minimumof50unitsisnotfeasible,refertotheNumberofUnitsNeededin“GuidelinesforCompendialTesting”

Figure2FieldSamplingstrategyfortablets

8

2.6. CriteriaforPrioritizationofSampling

PrioritywasgiventothefollowingAPIsanddosageforms:

• First-linetreatmentintheDOMCtreatmentguidelines

• Most-soldmedicines

• Mostcommonly-usedmedicinestoreflecttherealityofconsumedmedicinesfromallavailablesectors

• Medicinesknownorsuspectedtobecounterfeitsorsub-standardorforwhichadversedrugeventshadbeenreported.

2.7. CriteriaforDiversificationofSampling

Attemptsweremadetotryanddiversifythesamplescollectedfromeachsitetoreflecttheavailability in the market. The following characteristics to diversify the sampling wereconsidered:

• DifferentbrandsofthesameAPI;

• Differentbatch/lotnumbers;

• Multiple dosage forms (tablets, capsules, oral suspensions, injectables,suppositories,etc.);

• Differentsectors(private/public/informal);

• Differentsourcesoroutletsofthesameproductwithsamelotnumber

• Suspiciousmedicines;

• Improperly storedmedicines at the sampling site (exposed to sunlight, humid/wetconditions,etc.);and,

• Differentpackagingofsameproduct(i.e.,blistervs.bulk)

2.8. SampleCollection

ASamplingChecklist(Annex1)-wasprovidedtothesamplingteampriortotheirdeparturetocollectionsitesandtheneedforitsconsistentusewasemphasized.Eachsiteplannedtocollectapproximately80samplesalthoughsomesitescollectedlargeramounts.

Each collected sample was secured in a plastic container or sealable plastic bag andattached to its corresponding Sample Collection Form (Annex 2). The Sample CollectionForm contained all traceable data that accompanied the sample from the site of thecollection to the site of Minilab testing and then to the quality control laboratory forconfirmatory testing. This was done in order to maintain a traceable record of sample’sidentityshoulditfailorresultsbedoubtful.

9

Samples were then packed, transported, and stored in such a way as to prevent anydeterioration,contamination,oradulteration.Sampleswerestoredandtransportedintheiroriginalsealedcontainers,accordingtothestorageinstructionsfortherespectiveproduct.

2.9. SampleAnalysis

Oncesampleswerecollected, theywere testedat three levels (Figure1). Level1was thesentinel site using Minilab tests (Physical inspection, disintegration and Thin LayerChromatography(TLC)),Level2wastheverificationtestcarriedoutinthelabusingMinilabbasicteststoverifysentinelsitedataand level3wastheconfirmatorytestingdoneusingfullcompendialtesting.

2.9.1. Level1BasicTestsutilizingtheMinilabsatSentinelSite

Basictestsincluded

a) Physical/Visual(P/V)Inspection,b) Disintegration,andc) ThinLayerChromatography(TLC)and

Thiswascarriedoutatthesentinelsites.TestresultswereclearlyrecordedforeachsampleontheBasicTestsAnalysisFormforSentinelSiteStaff(Annex3).Thetestresultsaregradedasfollows

i. Pass:Conformstoallthree(3)testsii. Fail:DoesNOTconformtoatleastone(1)ofthethree(3)testsiii. Doubtful:Conflictingor inconclusiveresults forat leastone (1)of thethree (3)

tests

Asubsetofsampleswassenttothelaboratoryforverificationtesting,asfollows:(RefertoFigure1—MQMAnalysisFlowChart.)

• 20%ofsamplesthatpassed*2

• 100%ofsamplesthatfailed**

• 100%ofsamplesthataredoubtful***

This subset of sampleswas sent with their respective forms attached (Sample CollectionFormandBasicTestsAnalysisFormforSentinelSiteStaff)totheNQCLforverificationandconfirmatorytesting.

2*Pass:Conformstoall3tests;**Fail:Doesnotconformtoatleastoneofthethreetests;Doubtful:Conflictingorinconclusiveresultsforatleastoneofthethreetests

10

2.9.2. Level2:VerificationofBasicTestsatNQCL

NQCLperformedverification testingby repeatingbasic testson thesubsetof samples (asdescribedabove).ResultsofeachsamplewererecordedclearlyontheBasicTestsAnalysisFormforNationalQualityControlLaboratoryStaff(Annex4).

Foranysamplesthatfailedorweredoubtful,theycontinuedtothethirdstageofanalysisforcompletecompendialtesting.

Compendial testing was performed on the following samples: (Refer to Figure 1—MQMAnalysisFlowChart.)

• 20%ofsamplesthatpassverificationtesting

• 100%ofsamplesthatfailverificationtesting

• 100%ofsamplesthataredoubtfulforverificationtesting

• 50-100%ofsulfadoxine-pyrimethamine(S/P)tablets/capsulesandothermedicineswithknownprecedentsofdissolutionfailures.

Level 1Type of Analysis: Basic Tests with Minilabs®

Site of Analysis: Sentinel Site Samples Analyzed: N = 100

Results: 80 pass, 10 fail, 10 doubtful

10%PASSN = 8

100%FAIL

N = 10

100%DOUBTN = 10

Level 2Type of Analysis: Verification of Basic Tests

Site of Analysis: National QC Lab Samples Analyzed: N = 28


10%PASSN = 1

100%FAIL

N = 10

100%DOUBTN = 6

Level 3Type of Analysis: Confirmatory Testing with Compedial Tests

Site of Analysis: National QC Lab Samples Analyzed: N = 17


Figure3Exampleofsampleflowforqualitytesting

2.9.3. Level3:ConfirmatoryTestingwithCompendialMethodsatNQCL

Ifcompendialtestingwastobeconductedandtherewereinsufficientunits,moreunitsofthesamesamplewerecollectedtoensurefullcompendialtestingtookplace.

11

3. RESULTS

3.1. SampleDescription

3.1.1. SamplingbySector

Thesamplingwasdonefromthreesectorsnamelytheprivate,publicandinformalsectors.Sampling in theprivatesectorwashighestowing to thewider rangeofanti-malarials675samples came from the private sector representing 76% of all the samples. This wasfollowedbysamplesfrompublicthataccountedfor22%

Figure4Numberofsamplescollectedbysector

3.1.2. SamplingbyAPI

AL was the most sampled antimalarial followed by SPs, which is consistent with theiravailability.

Figure5SamplescollectedbyAPI

Private,675,76%

Public,194,22%

Informal,21,2%

Samplesdistributionbysector

AL,457,51%

AA,46,5%

SP,112,13%

AS,41,5%

DHAP,126,14%

QUI,108,12%

SamplesCollectedduringRoundFive

12

3.1.3. SamplingbyRegion

Duringroundfivefieldworkactivity,thelargestnumberofsampleswascollectedinNyanzafollowedbyRiftvalley,Western,CoastandNairobiregionsinthatorder.

No. Region Round5

1. Coast 1582. Nairobi 803. Nyanza 2464. RiftValley 2415. Western 165 Total 890

Table2DistributionofSamplescollectedbyregion

3.1.4. SummaryofSampling

Figure6Distributionofsampledmedicinesbysites

Round #ofSamples

Collected

#ofsamplesanalyzed

usingMinilab(Level1)

#ofSamplesfor

Level2analysis

#ofsamplesanalyzedby

compendiamethods(Level3)

Round5 890 879 102 82Table3Summaryofsamplingandanalysisofthefiverounds

3.2. RegistrationwiththePharmacyandPoisonsBoard

99.6% of the samples collected during the activity were duly registered with PPB. Thepercentageofunregisteredsampleshasconsistentlydecreasedvertime.

51 5338

4836 44 41

3145

33 37

4 3

3

6

31 6

7

39 1

5 2

7

11

16 8 1017

119 16

5 5

2

43 4

5 23

7 1

9 1217

713 17 10

712

10 12

7 5 139

7 7 8 1611

12 13

AL AA SP AS DHAP QUI

13

3.3. BasicandCompendialTestResults

3.3.1. Level1ScreeningTestResults

Ofthe879samplesscreenedatthesites,theproportionofsamplesinRound5thatpassedroundone screeningwas96%.3.8%of the sampleswereconsidereddoubtfulwhile0.2%failedthescreeningtest.

Figure7ReasonfordoubtfulresultinLevel1Testing


For round five, level II testing was not done but instead, all samples delivered to the

laboratoryunderwentcompedialtesting.

3.3.3. Level3CompedialTestResults

As there was no level 2-minilab testing, all the 102 samples from level 1 testing weresubmittedforcompendialtesting.82ofthesampleswereanalyzedwhile20sampleswerenotanalyzedastheyhadalreadyexpiredbythetimeofanalysis.74samplesor90.24%ofthesamplesanalyzedpassedanalysiswhile9.76%failed.

4

1

1

5

13

4

5

2

1

0 2 4 6 8 10 12 14

EXTRASPOTS

NOMONOGRAPH

RFDIFFERENCE

SAMPLESPOTLESSTHAN80%

SAMPLESPOTMORETHAN100%

(blank)

DIFFERENCEinRFValue

STAINEDAMPOULES

Dumbpowder(caking),intensityvariations

ReasonforDoubfulResults(n=36)

14

4. DISCUSSION

4.1. SampleDescription

4.1.1. SamplingbySector

The samplingwas done in three sectors namely the private, public and informal sectors.Sampling intheprivatesectorwashighestowingtothewiderrangeofanti-malarials.Thesamplesizesarecomparedacrossthefiveroundsofsampling(i.e.from2011–2014).Theprovatesectorcontributedthehighestnumberofsamplesat675followedbypublicsectorat194samplesand the leastnumberof sampleswas fromthe informal sectorat21.Theprivate sector has awide variety of products comparedwith the public sector hence thehighestnumberof samplesas comparedwith theother sectors. The samplingduring thisround mirrors the sampling in the previous four rounds whereby more samples werecollectedintheprivatesectorfollowedbypublicandinformalsectorrespectively.

Sector Round1 Round2 Round3 Round4 Round5

Private 312 373 301 415 675Public 169 118 229 157 194Informal 55 8 15 33 21Total 536 499 545 605 890

Table4Numberofsamplescollectedfortherounds

4.1.2. SamplingbyAPI

ALwasthemostsampledantimalarialfollowedbySPswhichisconsistentwiththeiravailability.

Figure8SamplescollectedbyAP

SamplesCollectedduringRoundFive

15

API Round1 Round2 Round3 Round4 Round5

Artemether/Lumefantrine 290 258 288 349 457Sulfadoxine/Pyrimethamine 101 105 106 133 112QuinineSulphate 83 85 77 77 10Artesunate/Amodiaquine 14 40 21 42 46QuinineDihydrochloride - - 3 4 98Sulfamethopyrazine/Pyrimethamine - 11 - - -DihydroartemisininPiperaquine 19 - 49 - 126Other 29 - 1 - Total 536 499 545 605 890

Table5DistributionofsamplesbyActivePharmaceuticalIngredients

4.1.3. SamplingbyRegion

Duringroundfivefieldworkactivity,thelargestnumberofsampleswascollectedinNyanzafollowedbyRiftvalley,Western,CoastandNairobiregionsinthatorder.

ThetablebelowshowsthenumberofsamplesinthevariousregionsfromRound1toRound5

No. Region Round1 Round2 Round3 Round4 Round5

1. Coast 107 99 115 100 1582. RiftValley 128 100 105 102 2413. Nairobi 100 100 108 101 804. Nyanza 101 100 100 101 2465. Western 100 100 117 101 1656. Garissa - - - 49 -7. Turkana - - - 52 - Total 536 499 545 606 890

Table6DistributionofSamplescollectedbyregion

16

4.1.4. SummaryofSampling

Figure9Distributionofsampledmedicinesbysites

Round Total#of

Samples

Collected

#ofsamplesanalyzed

inthefieldusing

Minilab(Level1)

#ofSamples

submittedto

referencelabforLevel

2analysis

#ofsamplesanalyzed

atreferencelabusing

compendiamethods

(Level3)

Round1 536 451 80 44Round2 499 496 65 25Round3 545 514 71 20Round4 606 117 112 115Round5 890 879 102 82Table7Summaryofsamplingandanalysisofthefiverounds

4.2. RegistrationwiththePharmacyandPoisonsBoard

Figure2showstheregistrationstatusofthesamplesoverthefiveroundsofpostmarketingsurveillance.Thepercentageofunregisteredsampleshasconsistentlydecreasedovertime.

17

Figure10RegistrationStatusofPMSsamplesoverthefiverounds

4.3. BasicandCompendialTestResults


Ofthe879samplesscreenat thesites, theproportionofsamples inRound5thatpassedroundonescreeningwas96%.Thehighestscreeningpassratewasinroundtwowhere97%ofthescreenedsamplespassedwhiletheleastwasinroundfourwhere82%passed.3.8%ofthescreenedsamplesweredoubtfulwhile0.2%failedthescreeningtests.Thehighest-level 1 screening failure was during round one where 5% of the samples failed analysis.Round4 had thehighest doubtful results at 17%while round2 had the least at 1%. Thesummaryofthepreviouslevel1screeningtestscanbeseeninthefigurebelow.

Figure11Resultsoflevel1screening

93.6

96.8

99.1 99.3 99.6

90.0

91.0

92.0

93.0

94.0

95.0

96.0

97.0

98.0

99.0

100.0

Round1 Round2 Round3 Round4 Round5

PercentageofSamplesRegistered

2010-2015(n=545,499,545,606and884)

92 97 94.682

96

5 2 0.8 1 0.23 1 4.617

3.80

20

40

60

80

100


LevelOneScreeningTestResultsin%

Pass Fail Doubtful

18

Figure12:ResultsofLevel1Testing

Figure13ReasonfordoubtfulresultinLevel1Testing


ThefigurebelowshowsresultsofthepreviouslevelIItesting.Forroundfive,levelIItestingwasnotdonebutinstead,allsamplesdeliveredtothelaboratoryunderwentcompedial

testing.

Figure14:ResultsofLevel2Testing

4

1

1

5

13

4

5

2

1

0 2 4 6 8 10 12 14

EXTRASPOTS

NOMONOGRAPH

RFDIFFERENCE

SAMPLESPOTLESSTHAN80%

SAMPLESPOTMORETHAN100%

(blank)

DIFFERENCEinRFValue

STAINEDAMPOULES

Dumbpowder(caking),intensityvariations

ReasonforDoubfulResults(n=36)

76%

100%90% 94%

3% 0% 3% 0%

21%

0%7% 6%

0%

20%

40%

60%

80%

100%

Round1 Round2 Round3 Round4

LevelTwoScreeningTestResults

Pass Fail Doubtful

19

4.3.3. Level3CompedialTestResults

Astherewasnolevel2minilabtesting,allthe102samplesfromlevel1testingweresubmittedforcompendialtesting.

Figure15Compedialtestingresults

4.4. DeterminantsofConformity

4.4.1. SectorofHealth

Samples from Public sector and private/ informal sectors had almost equal chances ofpassing the level I screening test.Therewasnosignificancedifference in the results fromthe two sectors although samples frompublic sectorshadahigherpass rateof 96.9%ascomparedto95.2%intheprivate/informalsector.

Sector Level1TestResults Total

Pass Fail/Doubtful

Public 188(96.91%) 6 194

Private/Informal 655(95.20%) 33 688

843(95.58%) 39 882

Table8Samplescreeningresultsbysector

8476

90100

90.24

1624

90.1

9.76


LevelThreeCompedialTestResults

Pass Fail Linear(Pass)

20

4.5. RegistrationStatus

The Pharmacy and Poisons Board registered 99.6% of round five samples collected. Thiscompareswellwiththe99.3%ofthesamplesthatwerefoundtoberegisteredduringroundfour.ThisisthehighestproportionregisteredsinceMalariaPMSstartedin2010.However,there was one product, Darte-Q Dihydroartemisinin/Piperaquine Phosphate Powdermanufactured by Gosun Pharma Corp. (G.P.C ) that was not registered in the countryalthough it passed compedial analysis. The unregistered product was quarantined andremovedfromthemarket.

4.6. ScreeningandCompedialTestResults

TheproportionofsamplesinRound5thatpassedlevalonescreeningwas96%.Thehighestscreeningpassratewasinroundtwowhere97%ofthescreenedsamplespassedwhiletheleast was in round four where 82% passed. Impurities in the TLC plate and intensity ofsample>80%accountedformorethanhalfofthefailedanddoubtfulsamples.

Consideringtheremarkablylowercostofminilabtestingandhowfastresultsareavailablecompared to laboratory testing, these findings highlights the value of this approach andencourage its continued use. The efficiency and value for money component for usingMinilabs is a key proponent for sustainability of the tracking quality ofmedicines at subnationallevels.

Of the102samplessubmitted forcompedialanalysis,82wereanalyzedwhile20sampleswerenotanalyzedastheyexpiredbeforebeingsubjectedtoanalysis.

74ofthe82thatwereanalyzedpassedcompedialtesting,givingapassrateof90.24%.Thiswasadropfromroundfourcompedialtestingwheretherewas100%passrate.

Thefollowingeightsamplesfailedanalysis

No. ProductName ActivePharmaceuticalIngredient Formulation Manufacturer TestFailed

1. ArtefanB/No.SB0074F

Artemether180mg/Lumefantrine1080mgper60ml

Suspension AjantaPharmaLtd

Assay

2. Co-coritherDrySyrupB/No.UCU1401


Syrup CoralLaboratories

Assay

3. LonartSuspensionB/No.LO-246


Suspension BlissGVSPharmaLtd

Assay

4. FansiderTabletsB/No.Z0248

Sulfadoxine500mg/Pyrimethamine25mg

Tablets AkaciaHealthcareLtd

AssayandWeightVariation

5. LonartSuspensionB/No.LO-243



Assay

6. CofantrinForteTabletsB/No.CF-101

Artemether80mg/Lumefantrine480mg

Tablets CometHealthcareLtd

AssayandWeightVariation

7. Co-coritherDrySyrupB/No.UCU1401


Syrup CoralLaboratories

Assay

8. P-AlaxinB/No.PAS-13

Dihydroartemisinin80mg/PiperaquinePhosphate640mg


Assay

Table9Listofproductsthatfailedcompedialtesting

21

Level1 testinghadhigh sensitivityand specificity rates fordetectionofpoorqualityanti-malarials.Consideringtheremarkablylowercostofminilabtestingandhowfastresultsareavailablecomparedtolaboratorytesting,thesefindingshighlightthevalueofthisapproachandencourageitscontinueduse.

Ahighproportionofanti-malarials,bothinthepublicandprivatesectors,conformedtotherequisite quality standards. The overall findings demonstrate the continued availability ofgood quality antimalarial medicines in the market- both ACTm and non-ACTm in thecountry.

4.7. RegulatoryActionsUndertakenbyPPB

Theeightproductsthatfailedanalysiswerequarantinedandremovedfromthemarket.Thesame applied to the product that was found as not registered in the country. PPB alsoinstitutedinvestigationstotracethesourceoftheproduct.

5. CONCLUSIONANDRECOMMENDATIONS

5.1. Conclusion

The proportion of poor quality anti-malarials continues to decline with the increasedsurveillance,improvedregulation.Almostalltheantimalarialsinthemarketareregisteredandmeetqualitystandards.

Theresultsobtainedwiththeminilabshowthatthiscosteffectiveandrapidmethodologyisof value and it is recommendable of institutionalize its use for postmarket surveillance,especially in border towns and areas prone to substandard medicines (risk-based Postmarketsurveillance).TheefficiencyandvalueformoneycomponentforusingMinilabsisakeyproponentforsustainabilityfortrackingqualityofmedicinesatsubnationallevels.

5.2. Recommendations

1. Regular post market surveillance should be institutionalized at the county level,preferably using minilabs for screening purposes, to ensure that all anti-malarialsavailabletothepopulationmeettherequiredqualitystandards

2. Prompt anddecisive regulatory action needs to be takenon failed samples to rapidlytake them out of the market and on manufacturers whose products do not meetregulatoryrequirements

3. Products with longer expiry dates should be considered when the fieldwork is beingcarriedout.

22

4. Promptcompedialanalysisofthesamplescollectedfromthefieldshouldbecarriedoutsoastopreventtheexpiryofsamplesbeforeanalysis.

5. A database of the post marketing surveillance should be developed and regularlyupdatedsoastomonitorproductsthatrepeatedlyfailanalysis

6. Countiesandotherpublichealthprogramsshouldconsiderusingthistypeofmonitoringthequalityoftheirmedicinesasitisaffordableandonegetsresultsfaster

7. Expand the use of minilab to monitoring other groups of medicines apart fromantimalarials

8. Promotethetechniquetothecountiessothattheycanuseittomonitorthequalityofmedicinesthattheyareprocuring

23

6. REFERENCES

1.President'sMalariaInitiative.President'sMalariaInitiative:FightingMalariaandSavingLives.[Online][Cited:May19,2015.]http://www.pmi.gov/where-we-work/kenya.

2.DivisionofMalariaControl[MinistryofPublicHealthandSanitation],KenyaNational

BureauofStatistics,andICFMacro.2010KenyaMalariaIndicatorSurvey.Nairobi:DOMC,KNBSandICFMacro,2011.

3.President'sMalariaInitiative(PMI).MalariaOperationalPlanFY2015.2015.

4.KenyaMalariaIndicatorSurvey2015,NMCP,KNBS,ICFInternational

24

7. ANNEXES

7.1. SamplingChecklist

BeforedepartingforsentinelsiteswiththeintentionofsamplingforaMedicineQualityMonitoring(MQM)program,checkthatyouhavealltheitemslistedbelow.

Task

1.SufficientSamplingFormsFilloutoneformforeachsample.

2.SamplingPlanPrepareasamplingplaninaccordancewiththeMQMprotocolandplanaheadforeachdayofsampling.

3.SamplingToolsEachsamplingteammusthavethefollowingtools:

• Newplasticorglass,opaque,cleancontainerstostoreandtransportsamples

• Mapforthedesignatedsitewithlistedsourcesofsamplecollection

• Scissors,gloves,cleanspatulaorspoon,forceps,tape,watch,labels

• Indeliblemarkersforlabelingthesamplingcontainers

• Indeliblepenstocompleteforms

• Cardboardbox(es)tostorecollectedsamples.

4.Notebook(onepersamplingteam)UseanotebookdedicatedtoonlyMQMcollectionstorecordadditionalinformationaboutsamplingactivities.

5. LogisticsMoneyfortransportation,purchasingsamples,food,lodging,andotherincidentals.

6.Optional itemsDigitalorconventionalcamera,mobilephone,globalpositioningsystemdevice,andotheritemsasnecessary.

25

7.2. SampleCollectionForm

Date(day/month/year)

NameofSite

NameofCollector

SignatureofCollector

SAMPLEINFORMATIONSamplecode1

Completesiteaddress(Nameoflocation,streetaddress,contactinformation,ifapplicable)

Sectorofsite(public,privateorinformal)

Descriptionofdispensingsite(pharmacy,healthclinic,hospital,warehouse,etc.)

Commercialdrugname

INN2

Pharmaceuticalpresentation(tablet,capsule,injectable,etc.)

Dosage(mg)

Manufacturername

Manufacturer’sbatchorlotnumber

Manufacturingdate(ifpresent)

Expirydate

Registrationorlicensenumber(ifapplicable)

Manufactureraddress

Numberofunitscollected3

Packagedescription:• Typeofpackage(blisterpack/card,bottle,othersspecify)

• Numberofunits/pack• Presenceofinsert/leaflet

Checkone: takeninoriginalpackagetakenfrombulkcontainer

Instructionstostoresample(e.g.,keepmedicineawayfromlightandat25◦)

Storageconditionsatsite4 1Adaptaccordingtoprogramorcountryneeds,suggestedwillbe(A/B/C/D/E):A:NameofCountry,B:INN/API,C:CollectionSite;D:DateofCollection;E:SequentialNumber.2INNistheInternationalNon-proprietaryNameofadrugproduct,alsoknownasActivePharmaceuticalIngredient(API)3Iffewerthanthenumberrequiredbytheprotocol,pleaseexplain.4Pleasedescribethegeneralstorageconditionsofthesamplingsite(e.g.,medicinesexposedtosunand/orair,notemperatureand/orhumiditycontrol,watervisibleinstorageroom,medicinesstackedinappropriately,etc.)*Samplecollectionformshouldbeattachedtothesampleandadditionalcopiesshouldberetainedasindicatedintheprojectprotocol.

26

7.3. BasicTestsAnalysisFormforSentinelSiteStaff

SampleCode

DateofAnalysis(dd/mmm/yyy)

SentinelSiteofAnalysis

NameofAnalyst

SignatureofAnalyst

TEST1:VISUAL&PHYSICALINSPECTION

VisualInspection:

PleaseconfirmthatalloftherecordedinformationintheSampleCollectionForm(Annex2)isconsistentwiththepackagingandlabelingofthemedicine.CorrecttheSampleCollectionForm(Annex2)ifthereareanyerrorsand/oromissions.3

Haveanycorrectionsand/oradditionsbeenmadetoSampleCollectionForm(Annex2):

☐Yes☐No

OtherComments(descriptionofhologram,anyprintonthebackingfoil,etc.)

PhysicalInspection:

Shape(circular,oval,flatsides,other)

Uniformityofshape

Uniformityofcolor

Nophysicaldamage(cracks,breaks,erosion,abrasion,sticky)

Otherobservations(noforeigncontaminant,dirtymarks,properseal-forcapsule)

TEST2:DISINTEGRATION4

Timeofobserveddisintegration(minutes)

1. _______________

2. _______________

3. _______________

Didthedrugpassthedisintegrationtest?

☐Yes☐No

3 If any corrections/ additions were made to the Sample Collection Form, initial and date all added information 4 Disintegration tests are 30 minutes; for testing at sentinel sites perform only 3 tablets/capsules. If one or more units do not disintegrate classify the sample as failing basic tests and send for confirmatory tests. For confirmatory testing please refer to the testing protocol.

27

TEST3:TLC

Didthesamplehaveaspot?☐Yes☐No

RfStandard:__________

RfSample:___________

Rf%Sampledifference:5_______________

Intensityofsamplespotcomparedtostandard:

Less than 80%

Between 80% and 100%

More than 100%

Werethereanycontaminants/impuritiespresent?

☐Yes☐No

Observations:_______________________________

FINALRESULTS

The sample conformed with ba s ic tests

The sample did not conform with ba s ic testsReason:____________________________________

The sample is cons idered doubtfulReason:___________________________________________

Howmanyunitsareremainedafterbasictests?_________________________________________

REPORTREVIEWEDBY6:

Name:________________________________Signature:_______________________________

Date:_________________________________

5 Rf % Sample Difference = |"# !"#$%#&% -!" !"#$%& |

!" (%&'()'*)) ×100

In this formula | !" !"#$%#&% − !" !"#$%& | represents the absolute value of the difference between the Rf's of the standard and the sample. Ex: In a TLC run the following values are obtained: Rf (standard) = 0,55, Rf (sample) = 0,57; The Rf % Sample

Difference = |".$$-!.#$|!.## ×100 = !.!#!.## ×100 =3.6% 6Ifapplicable

28

7.4. BasicTestsAnalysisFormforNationalQualityControlLaboratoryStaff

SampleCode

DateofAnalysis(dd/mmm/yyy)

SentinelSiteofAnalysis

NameofAnalyst

SignatureofAnalyst

TEST1:VISUAL&PHYSICALINSPECTION

VisualInspection:

PleaseconfirmthatalloftherecordedinformationintheSampleCollectionForm(Annex2)isconsistentwiththepackagingandlabelingofthemedicine.CorrecttheSampleCollectionForm(Annex2)ifthereareanyerrorsand/oromissions.7Haveanycorrectionsand/oradditionsbeenmadetoSampleCollectionForm(Annex2):

☐Yes☐No

OtherComments(descriptionofhologram,anyprintonthebackingfoil,etc.)

PhysicalInspection:

Shape(circular,oval,flatsides,other)

Uniformityofshape

Uniformityofcolor

Nophysicaldamage(cracks,breaks,erosion,abrasion,sticky)

Otherobservations(noforeigncontaminant,dirtymarks,properseal-forcapsule)

TEST2:DISINTEGRATION8

Timeofobserveddisintegration(minutes)1. _______________2. _______________3. _______________

Didthedrugpassthedisintegrationtest?☐Yes☐No

TEST3:TLC

Didthesamplehaveaspot?☐Yes☐NoRfStandard:___________RfSample:____________Rf%Sampledifference:9_______________

Intensityofsamplespotcomparedtostandard:

Less than 80%

Between 80% and 100%

7 If any corrections/ additions were made to the Sample Collection Form, initial and date all added information 8 Disintegration tests are 30 minutes; for testing at sentinel sites perform only 3 tablets/capsules. If one or more units do not disintegrate classify the sample as failing basic tests and send for confirmatory tests. For confirmatory testing please refer to the testing protocol. 9 Rf % Sample Difference = |"# !"#$%#!" -!" !"#$%& |

!" (%&'()'*)) ×100

In this formula | !" !"#$%#&% − !" !"#$%& | represents the absolute value of the difference between the Rf's of the standard and the sample. Ex: In a TLC run the following values are obtained: Rf (standard) = 0,55, Rf (sample) = 0,57; The Rf % Sample Difference

= |".$$-!.#$|!.## ×100 = !.!#!.## ×100 =3.6%

29

More than 100%

Werethereanycontaminants/impuritiespresent?☐Yes☐NoObservations:_____________________________

FINALRESULTS

The sample conformed with ba s ic tests

The sample did not conform with ba s ic testsReason:____________________________________

The sample is cons idered doubtfulReason:___________________________________________

Howmanyunitsareremainedafterbasictests?_________________________________________

REPORTREVIEWEDBY10:

Name:________________________________Signature:_______________________________

Date:_________________________________

10Ifapplicable

30

7.5. ListofSampledFacilities

Region NameofFacility Address Sector Type

Busia NamulwaniChemist PortVictoria Private PharmacyBusia AlupeSubCountyHosp Box35Busia Public HospitalBusia AmoPharmacy Box322Maraba Private PharmacyBusia AmukuraPharmacy Box353-50408Kimurai Private PharmacyBusia BungomaChemistsLtd Box1053Bungoma Private WholesaleBusia BungomaDistrictHosp Box14Bungoma Public HospitalBusia BunyalaHealthcare

ChemistPortVictoria Private Pharmacy

Busia BusiaCountyReferralHosp

Box87,Busia Public Hospital

Busia CFWClinicsBumala Box1630-00606Nairobi Private PharmacyBusia EastEndChemistLtd Box782Bungoma Private WholesaleBusia HolyFamiilyHospital

NanginaBox57Funyula-Samia Private Hospital

Busia KimaetiHealthCentre Box2313Bungoma Public HealthCentreBusia MalabaDispensary Malaba Public DispensaryBusia MubwekasMedicalClinic Box777Busia Private ClinicBusia NamulwaniChemist PortVictoria Private PharmacyBusia OgmaxChemist PortVictoria Private InformalBusia PortVictoriaSub-County

HospitalPortVictoria Public Hospital

Busia ScorpionPharmacyLtd Busia Private PharmacyBusia TheEaglePharmacy Box85,Funyula Private InformalKajiado AICHospital AlongNamanga-KajiadoRoad Public HospitalKajiado BellmontLateNight

ChemistSampuBuilding,MainStreet,KajiadoTown

Private Wholesale

Kajiado CloritiPharmaceuticals(E.A)Ltd

Dayalal&SonsBuilding-NgonTown

Private Whole

Kajiado DrugHealPharmacy AlongPipelineRoad Private InformalKajiado EdmercPharmacy KazaroBuilding,Opp.Eastmatt

SupermarketPrivate Retail

Kajiado EmbulbulCatholicDispensary

OffNgongKarenRoad Private Dispensary

Kajiado EretetiDispensary AlongPipelineRoad Public DispensaryKajiado IsinyaHeathcentre OffNamangaKajiadoRoad Public HealthcentreKajiado IslandPharmaceuticals AlongKajiadoTownMain

StreetOpp.CentralHotelPrivate Retail

Kajiado KajiadoDistrictHospital OffNamangaRoad Public CountyStoresKajiado Kenmaiso

PharmaceuticalsLtdMailiTisaStage-Namanga Private Retail

Kajiado KisajuPharmaceuticals AlongIsinyaHealthcentreRoad Private RetailKajiado KitengelaMedical

ServicesEPZViwandaniRoad Private Hospital

31

Kajiado KitengelaSubCountyHosp

PrisonsRoad Public Hospital

Kajiado LexaMedicalCentre AlongNamangaAmboseliRoad

Private Hospital

Kajiado MabroukPharmaceuticals

OffNamangaKajiadoRoad Private Retail

Kajiado MagadiSodaCompanyHospital

MagadiSodaKiserianRoad Private Hospital

Kajiado Mile9Chemist AlongKajiadoNamangaRoad Private InformalKajiado MontanaHealthcare AlongNairobiNamangaRoad Private RetailKajiado NamangaDrugHouse OffNamangaRoad Private WholesalerKajiado NgongSub-County

HospitalOffNgongRoad Public Hospital

Kajiado SamjosPharmacy LeiserHillPlaza,OffMagadiRoad,OngataRongai

Private Retail

Kajiado ShephardsChemist&Agrovet

AlongEquityStreet,OppositeCooperativeBank

Private Retail

Kajiado St.TheresaDispensaryCarmeliteMissionaries

MarketArea,Kitengela Public Hospital

Kajiado TopcareNursingHome AlongMiriamRoad Private ClinicKajiado UzimaMedicalClinic NaMangaTown Private ClinicKajiado ZamzamMedicalServices OffNgongRoad Private ClinicKakamega AhmadiyaMuslim

Hospital,Shianda,OffMumias-KakamegaRoad Private Hospital

Kakamega EmuhayaCentreP.O50.Emuhaya

AlongLuanda-StandkisaRoad Public Hospital

Kakamega EquatorMedicalServices AlongKisumu-BusiaRoad Private ClinicKakamega IguhuCountyHospital, OffKsm-KakamegaRoad Public HospitalKakamega JamiaMedicalCentre, OffMumias-KakamegaRoad Private HospitalKakamega JamiiToshaPharmacy Opp.KakamegaCounty

ReferralHospitalPrivate Pharmacy

Kakamega KakamegaCountyReferralHospital,

Kakamega-KisumuRoad Public Pharmacy

Kakamega KhayegaMedicalClinic, AlongKakamega-KisumuRoad Private HealthClinicKakamega KilingiliHealthCentre, KilingiliMarket,StandKisa-

LuandaRoadPublic Hospital

Kakamega LukoseChemist, ChavakaliMarket Informal PharmacyKakamega MakungaRuralHealth

DevelopmentCentre,OffKakamega-MumiasRoad Public Hospital

Kakamega MalavaCountyHospital MalavaTown,KakamegaWestRoad

Public Hospital

Kakamega RayetChemist LuandaMarket,Kisumu-BusiaRoad

Private Pharmacy

Kakamega StElizabethMukumuMissionHospital

Khayega,AlongKakamega-KisumuRoad

Private Hospital

Kakamega StMarysMissionHospitalMumias,

Mumias-Kakamega,Mumias Private Hospital

Kakamega TibaChemists, ChavakaliTown,Kisumu- Private Pharmacy

32

KakamegaHighwayKakamega TonyChemist, Kakamega-KisumuRoad Private PharmacyKakamega VihigaCountyReferral

Hospital,MbaleTown Public Hospital

Kericho AdakimChemists Kericho Private WholesalersKericho DelachChemists Kericho Private PharmacyKericho DiscountPharmacy Kericho Private RetailKericho ElementaitaPharmacy NaivashaTown Private PharmacyKericho ElimPharmacy Nakuru Private WholesalersKericho FavoursChemist Kericho Private PharmacyKericho FigTreeHealthOptions Kericho Private ClinicKericho G.K.PrisonDispensary Kericho Public DispensaryKericho KapkatetCountyHosp Kericho Public HospitalKericho KerichoCountyStores Kericho Public StoresKericho KerichoMedicalCentre Kericho Private ClinicKericho KerichoNursingHome Kericho Private HospitalKericho KerichoOutpatient

MedicalCentreKericho Private Clinic

Kericho KubwaHealthcare NaivashaTown,InsideNaivasSupermarket

Private Pharmacy

Kericho LiteinMssionHospital Kericho Private HospitalKericho NeuroChemista Kericho Private PharmacyKericho PishonChemist Nakuru Private PharmacyKericho SiloamHospital Kericho Private HospitalKericho StLeonardsKericho Kericho Private HospitalKericho StMary'sMission

HospitalNaivashaTown Private Hospital

Kericho St.LeonardsNyagacho Kericho Private HospitalKericho TealandsChemists Kericho Private WholesalersKericho Transwide

PharmaceuticalsNakuru Private Pharmacy

Kericho UnnamedChemist Kericho Informal KioskKisii AmaniClinic Suneka Private ClinicKisii BitareHealthCentre Nyambunwa Public HealthCentreKisii BonmedPharmacy Keroka Private PharmacyKisii BosongoChemist Kisii Private PharmacyKisii GetembePharmacy Kisii Private PharmacyKisii GuchaNursingHome Keroka Private NursingHomeKisii ImaraChemist Mwembe Private PharmacyKisii KerokaDist.Hospital Keroka Public HospitalKisii KeumbuDistrictHospital Keumbu Public HospitalKisii KisiiCountyStore Kisii Public StoreKisii MeridianFourPharmacy Kisii Private PharmacyKisii NyanchwaMedical

CentreNyanchwa Public Hospital

33

Kisii RamHospital Kisii Private HospitalKisii SpaceChemist Keroka Private PharmacyKisii Verleon Mwembe Private PharmacyKisumu AgaKhanHospital

KisumuKiisumu-KakamegaRoad.NearKibuyeMarket

Private Hospital

Kisumu AvenueHospital Kisumu-KakamegaRoad. Private HospitalKisumu ChadorClinic JomoKenyattaStreetKisumu.

ChekmullaBuildingPrivate HealthClinic

Kisumu ChulaimboTeachingAndReferralHospital

Kisumu-BusiaRoadChulaimbo Public Hospital

Kisumu God'sWillCentre Simba,Nyalenda,Kisumu. Private ClinicKisumu HarleysPharmaceuticals

LtdOgingaOdingaStreet.KisumuTown

Private Wholesale

Kisumu JalaramHospital Kisumu-KakamegaRoad. Private HospitalKisumu KatitoGatewayPharmacy Kisumu-OyugisRoad. Private RetailKisumu KentonsLtd OgingaOdingaStreet.Kisumu

TownPrivate Wholesale

Kisumu KibosPrisonDispensary Kisumu-KibosRoad. Public DispensaryKisumu KisumuEastDistrict

HospitalAng'awaAvenue. Private Public

Kisumu LeoChemistsLtd Kisumu-KakamegaRoad.Opp.JOOTRH

Private Retail

Kisumu NamelessChemist Kisumu-OyugisRoad.KatitoMarket

Informal Kiosk

Kisumu NamelessChemist Nyalenda.NextToKiloStage Informal KioskKisumu NamelessChemist Kisumu-NairobiHighway.

NyamasariaInformal Kiosk

Kisumu NamelessChemist Kisumu-OyugisRoad.KatitoMarket

Informal Kiosk

Kisumu PortFlorenceCommunityHospital

OgingaOdingaStreet,MegaPlaza.KisumuTown

Private HealthClinic

Kisumu RamogiChemistsLtd Ang'awaAvenue.NextToFireStation,KisumuTown

Private Retail

Kisumu ShanobPharmacy Kondele-KibosRoad,NextToJuventureGuestHouse

Private Retail

Kisumu SonduHealthCentre Kisumu-OyugisRoad.SonduMarket

Public HealthClinic

Kisumu St.Joseph'sNyabondoMissionHospital

Kisumu-OyugisRoadSondu.Nyabondo

Private Hospital

Kisumu St.Monica'sHospital Kisumu-KakamegaRoad. Private HospitalKisumu TayyibahMedicalCentre NextToTayyibahMosque, Public HealthClinicKisumu VictoriaPharmaceuticals

LtdOtuomaStreet,CentralSquare.KisumuTown

Private Wholesale

Kwale AfiaChemist Kinango Private PharmacyKwale CornerPharmaceuticals Kinango Private PharmacyKwale DynoKombaniChemist Likoni Private PharmacyKwale FisterChemist LungaLunga Private Pharmacy

34

Kwale KinondoKwetuHealthServices

Kinondo Private HealthClinic

Kwale LanPharmaceuticals Msabweni Private PharmacyKwale LikoniDistrictHospital Likoni Public HospitalKwale MsabweniDistrict

HospitalMsabweni Public Hospital

Kwale OceanicBrightPharmacy Diani Private PharmacyKwale OtienoChemist Ukunda Private PharmacyKwale PalmBeachHospital Diani Private HospitalKwale SavanahChemist Kinango Private PharmacyKwale SeasidePharmacy Ukunda Private PharmacyKwale SeasidePharmacy Likoni Private PharmacyKwale SouthCoast

PharmaceuticalsUkunda Private Pharmacy

Kwale UkundaCatholicDispensary

Ukunda Public HealthClinic

Kwale UkundaMedicalCenter Ukunda Private HospitalMigori AkidivaMemorial

HospitalOffMigori-SirareHighway Private Hospital

Migori BomaMedicareLtd OppositePostOffice,MigoriTown


Migori BukuriaMedicalCentre IsebaniaTown-OppTranslineBusStage


Migori GetontiraMedicalClinic OppMosque-IsebaniaTown Private HealthClinicMigori IgenaPharmacy IsebaniaTown-OppTransline

BusStagePrivate RetailPharmacy

Migori KandariaPharmacy MainStage-Migori Private RetailPharmacyMigori KisaoPharmacy NextToKcb-Sirare Private Wholesale

PharmacyMigori MigoriDistrictHospital NextToCountyGovernment

OfficesPublic Hospital

Migori MigoriStagePharmacy Awendo-MariwaRoad Private RetailRetailPharmacy

Migori MillestCosmeticsAndPharmacy

OrubaEstate-Migori Informal Pharmacy

Migori MonicarePharmacyLtd Kisii-MigoriHighway Private RetailPharmacyMigori NyarangaCentral

PharmacyNextToSherlingSupermarket-Migori

Private WholesalePharmacy

Migori NyaseseDispensary NextToNyasesePrimarySchool

Public Dispensary

Migori PastorMachageHospital Migori-SirareHighway Private HospitalMigori PioneerChemistAnd

CosmeticsRanenCentre-Migori-SirareHighway

Informal Pharmacy

Migori PishonChemist OrubaEstate-Migori Private RetailPharmacyMigori RongoDistrictHospital OffKisii-MigoriHighway Public HospitalMigori SilverlaneChemist RongoTown,MimosaStreet Private RetailPharmacyMigori St.JosephMission OppositeMigoriHighSchool Private FboHospital

35

Hospital,OmboMigori StageViewChemist Awendo-MariwaRoad Private RetailPharmacyMigori VibraPharmacy Kisii-MigioriHighway,Migori Private Wholesale

PharmacyMigori Zack-4Chemist RongoTown,NextKcb Private RetailPharmacyMombasa AdamsChemists KerichoStreet Private PharmacyMombasa CoastGeneralHospital HospitalRoad Public HospitalMombasa CommunityHealth

ServicesPharmacyKongoeaEstate Private Pharmacy

Mombasa FramuChemist KongoeaEstate Private PharmacyMombasa JochamHospital Kisauni-MalindiRoad Private HospitalMombasa KengeleniPharmacy Kisauni-MalindiRoad Private PharmacyMombasa KisauniPharmacy Kisauni Private PharmacyMombasa MakupaChemists KenyattaAvenue Private PharmacyMombasa MewaHospital MajengoEstate Private HospitalMombasa MidlifePharmacy HospitalRoad Private PharmacyMombasa MikindaniHealthCentre MikindaniEstate Public ClinicMombasa MombasaHospital MamaNginaStreet Private HospitalMombasa NjimiaPharmaceuticals DigoRoad Private WholesalerMombasa PandyaMemorialHosp DedanKimathiStreet Private HospitalMombasa PortreitzSubcounty

HospitalAirportRoad Public Hospital

Mombasa PsalmchemChemist MikindaniEstate Private PharmacyMombasa SerenaPharmacyLtd HospitalRoad Private PharmacyMombasa ShifaChemLimited KenyattaAvenue Private PharmacyMombasa SumaiyaChemist KingoraniEstate Private PharmacyMombasa SumebPlusPharmacy AirportRoad Private PharmacyMombasa SurgipharmLtd NyerereAvenue Private ImporterMombasa TerichemChemist MikindaniEstate Private PharmacyMombasa TudorSubcountyHospital TudorEstate Public HospitalNairobi BatianPeakPharmacy KNHPlazaNairobi Private PharmacyNairobi CapitalChemist AlongOlympicRoadKibera Informal StreetVendorNairobi Chemist AlongOlympicRoadKibera Informal RetailerNairobi CopticHospital NgongRoad,Opp.Maki

ApartmentsPrivate FboHospital

Nairobi DajimPharmacyLtd NaivashaRoadOppPostBankUthiru

Private Pharmacy

Nairobi GakoeDispensary P.OBox84GatunduKiambu Public HospitalPharmacy

Nairobi KagaaDispensary P.OBox37GithunguriKiambu Public HospitalNairobi KentPharmaceuticalsLtd NyakuHouse,Hurlingham Private RetailerNairobi KiandutuHealthCentre P.OBox3304-01002Thika Public Hospital

PharmacyNairobi KianyiPharmacy P.OBox1986-00900Kiambu Private PharmacyNairobi MakongeniHealthCentre P.OBox1747-01000Thika Public Hospital

36

MakongeniEstate PharmacyNairobi MalibuPharmacy P.OBox69652-00400-

NairobiPrivate Pharmacy

Nairobi MaxPharmaceuticals P.OBox320-00519Mlolongo Private PharmacyNairobi MbagathiHospital OffMbagathiWayKenyatta

MarketNgumoPublic Hospital

PharmacyNairobi Meds MombasaRoad Public FBOWarehouseNairobi MenyaChemists P.OBox2297Thika Private PharmacyNairobi MivjiziClinic KatwekeraKibera Informal StreetVendorNairobi NairobiWestHospital GhandiaAvenue,NairobiWest Private Hospital

PharmacyNairobi NamPharmacy Uthiru'OffNaivashaRoad Private RetailerNairobi NjimiaPharmaceuticals LandmarkPlaza,2ndFloor,

ArgwingsKodhekRoad,Private Wholesaler

Nairobi OlympicChemist AlongOlympicRoadKibera Informal StreetVendorNairobi ShalomCommunityHosp P.OBox505-AthiRiver Private Hospital

PharmacyNairobi SolaceChemists MurathaRoadKangemi Private RetailerNairobi SurgipharmLimited NininaTowers,WestlandsRd,

OppositeCfcStanbicPrivate Distributer

Nairobi TheNairobiWomensHospital

OffArgwingsKodhekRoad,Hurlingham

Private Hospital

Nairobi ThikaNursingHome Section9OAU-Road Private HospitalPharmacy

Nairobi TranschemPharma UchumiBuildingNairobi Private WholesalerNairobi VIPSHealthServicesLtd WoodleyAlongKabarnetRoad Private FboHospitalUasinGishu AbbaPharmChemist EldoretTown Private PharmacyUasinGishu AcaciaMedicalClinic EldoretTown Private ClinicUasinGishu BarakaClinic ElortetTown Private ClinicUasinGishu CedarHospital EldoretTown Private HospitalUasinGishu DominionChemist EldoretTown Private PharmacyUasinGishu EldobaseChemists EldoretTown Private PharmacyUasinGishu EldohospPharmaceutical EldoretTown Private WholesaleUasinGishu EldoretRaphaClinic EdoretTown Private ClinicUasinGishu ElgonView EldoretTown Private HospitalUasinGishu ElirsChemist EldoretTown Private PharmacyUasinGishu GloryChemists EldoretTown Private PharmacyUasinGishu HurumaDistrict EldoretTown Public HospitalUasinGishu KimumuHealthCentre EldoretTown Public HealthCentreUasinGishu KuinetDispensary EldoretTown Public DispensaryUasinGishu LaborexKenyaLtd EdoretTown Private WholesaleUasinGishu MedihealHospitaland

FertilityCentreEldoretTown Private Hospital

UasinGishu MoiTeaching&Referral EldoretTown Public HospitalUasinGishu MoschemPharmacyLtd EldoretTown Private Pharmacy

37

UasinGishu RealeHospital EldoretTown Private HospitalUasinGishu ShadesPharmaceuticals EldoretTown Private PharmacyUasinGishu ShayonaChemistLimited EldoretTown Private PharmacyUasinGishu SinapharmSinaiChemist EldoretTown Private PharmacyUasinGishu StLukesOrthopedicAnd

TraumaHospitalEdoretTown Private Hospital

UasinGishu TayishaPharmacy EldoretTown Private PharmacyUasinGishu Transwide

PharmaceutialsEldoretTown Private Wholesale

UasinGishu UasinGishuDistrictHospital

EldoretTown Public Pharmacy

UasinGishu VictoryMedicalClinicAndDiagnosticCentre

EldoretTown Private Clinic

UasinGishu Westhealth EldoretTown Private Hospital

38

7.6. ListofData/SampleCollectionTeam

Team# TeamMembers CountiesVisited

1 1.Dr.SarahChesaro2.EdwinOsano3.NehemiaBirgen4.LillyKipkeno

NairobiMachakosKiambu

2 1.GedionToo2.LucyMugambi3.EvansKiprono4.GladwelCheruiyot

BaringoUasinGishuTransNzoiaElgeyoMarakwet

3 1.PatrickKibet2.HenryChweya3.MollyOkoth4.BeatriceObinge

SiayaKisumu

4 1.EnowHaji2.AthmanHemed3.PatrickKipyego4.EmilySiminyu5.LawrenceNzumbu

TaitaTavetaMombasaKilifi

5 1.MercyK.Siyoi2.GeorgeSankale3.NehemiahBirgen4.DrMikalAyiro

Kajiado

6 1.BeatriceObinge2.StephenOchieng3.EvansKiprono4.PeterKiptoo

MigoriHomabay

7 1.DrDonaldRatemo2.DrSamuelKerama3.PhillipMutinda4.AbdinasirSheikh

Kisii,Nyamira

8 1.DrTiberiusAdeya2.MiltonAnono3.GeorgeMuthuri4.NancyNyambega

Busia

9 1.DrAgnesAyoti2.ValentineMokaya3.GladwellCherogony4.AllanWambua

Kericho

10 1.YusufDimba2.DrKelvinNduhiu3.PatrickGachukia4.JamesKing’ori

Kwale

11 1.Dr.KarimWanga2.MaryKendi3.WashingtonOyoo4.PatrickKibiego

KakamegaVihiga

12. 1. AndrewNyandigisi2. EdwardAbwao3. LatifaElHadry

CentralSupervisory,M&E

39

P.O.Box2766300506LenanaRoadOppositeRussianEmbassyNairobi,Tel:+254-02-12345/6789,Fax:+254-02-12345,Website:www.Pharmacyboardkenya.org.ke

Email:[email protected]:Thisisacontrolleddocument.ItshallnotbecopiedwithoutauthorizationfromtheRegistrar.

Monitoring the Quality of Antimalarial Medicines … PMS...Executive Summary Malaria still accounts...

Documents

Transcript of Monitoring the Quality of Antimalarial Medicines … PMS...Executive Summary Malaria still accounts...