National Malaria Control Centre.docx

National Malaria Control Centre.docx

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NationalMalariaControlCentre

NationalMalariaControlCentre

AssessmentofPatientcompliancetoArtemether-LumefantrineinZambia

PascalinaChanda

MoongaHawela

December2005

Forcommentsandprintrequestscontact

OperationalResearchOffice

P.OBox32509

Lusaka,ZAMBIA

Tel:

282455

Email:

chandap@nmcc.org.zm

1.0Introduction

InZambia,malariaismajorcauseofillnessanddisease,thusithasbeenrecognisedasapublichealthpriorityarea（NHSP2005）.Itisestimatedthat37%ofalloutpatientattendancesareduetomalaria（ZDHS2002）.Annualmorbidityandmortalitytrendsshowatleast3millionclinicalcasesand50,000deaths.Theunderfive-mortalityrateis40%whilethematernalmortalityrateis20%（CBOH2003）.

Tothiseffect,theNationalMalariaControlProgramme（NMCP）inZambiahasembarkedonastrategicprocessofimplementingtheRBMobjectives.OneoftheRBMgoalsseekstoensureaccesstopromptdiagnosisandeffectivetreatment（WHO2000）.Inlinewiththisobjective,thenationalantimalarialdrugpolicywasrevisedtoreplacethefailingmonotherapieswithartemisinin-basedcombinationtherapy（ACTs）forthetreatmentofuncomplicatedmalaria.ACTsarehighlyefficaciousintreatinguncomplicatedmalariaandreducingthetransmissionofresistantgenes（Omarietal2002,Chandaetal2004）.

However,theeffectivenessofthedrugdoesnotonlydependonitsefficacy,butalsoonfactorssuchasadherence,drugquality,coverageandaccess（Barnesetal2005）.InthecaseofArtemether-lumefantrine（AL）,clinicaltrialshaveshownthattheefficacyisexcellentwhetheradministeredundercontrolledstudysettingsorroutineclinicoperations（Piolaetal2005,Omarietal2002）.

CoverageandaccesstoALiscurrentlynotaprobleminZambiaastheuseofACTsisnowanationwidephenomenoninallpublichealthfacilitiesownedbythegovernment.Malariatreatmentishighlysubsidisedbygovernment（andpartners）,hencereducingcostbarrierstoaccess.AlsothecountrywidedistributionprogrammebeingimplementedbyMedicalStoresLimited（MSL）,aprivatefirmcontractedbygovernment,ensuresthatthedrugsaredeliveredtoalldistrictsontimelyschedules（MOH2004）.

ThusamajorcasemanagementissueisassuringcomplianceintheuseofALformanagementofuncomplicatedmalaria.Non-compliancebytheprovidersandalsobythecaretakersaffectstherapeuticresponsetodrugs（Nshakiraetal2002）.Patientadherencetotheprescriptionandadviceofahealthcareproviderdeterminesthefinaleffectivenessofantimalarialtreatment（Abdinasiretal2004）,evenwithhighlyefficaciousAL.

TherecommendeddosageofALinZambiaisthesix-doseregimentobetakenoverthreedays,twicedaily.Thisdosingscheduleiseffectiveandresolvessymptomswithinashortperiodoftime,thus,patientsareatriskofnotcompletingthefulldoseespeciallyafterresolutionofclinicalsymptoms.

Itisthuscriticaltoasseshowcaretakersaretakingthetreatmentprescribedtothem.Thisisimportantbecausenon-compliancehasadversepublichealthconsequences.Subtherapeuticdosescanleadtorecurringmalariaepisodes,increasemalariaprevalence,exacerbatesevereanaemia,lowercureratesandthenencouragetheemergenceofparasiteresistance（Depoortereetal2004,White&Olliaro1996）.

Thisstudyisafollow-uptothe2004baselinestudywhichwasconductedaftertheinitialdeploymentofAL.Thiswillprovidetheprogrammewithinformationonthetrendsincomplianceovertimeandsodoingprovideabasisforimprovingtheimplementationprocessandprogrammeplanning.

2.0Aim

Toidentifyfactorswhichinfluencepatientnon-adherencetotreatmentprotocolsinmalariapatientsinZambia.

3.0SpecificObjectives

1.Tomeasurethelevelofcompliancetoartemether+lumefantrinesixdoseregimeninuncomplicatedmalariapatientsagedmorethan24months（orweightgreaterorequalto10Kg）seekingtreatmentathealthfacilities.

2.Todeterminewhetherartemether/lumefantrineisbeingcorrectlyadministeredbyhealthworkers.

3.Todeterminetherelationshipbetweencomplianceandsocialdemographicfactorsofthestudygroup.

4.Toassesthehealthproviderandcommunityperspectiveofthesafetyofartemether-lumefantrinefortreatinguncomplicatedmalaria.

4.0DescriptionoftheStudy

4.1StudyDesign

Thestudywasacrosssectionalsurveyindesign.ObservationsweremadeinmembersofthepopulationreportingathealthfacilitieswithsuspecteduncomplicatedPlasmodiumfalciparummalaria.Thestudylookedatwhetherallpatientsdiagnosedwithuncomplicatedmalaria（andhaveCoartem®prescribedtothem）getappropriateinformationonthetreatmentcourse.Thepatient’soutpatientdepartmentrecordswereusedtoobtaindataonage,sex,temperature,weightandresidentialaddress.

Patientswerevisitedathomeaftercompletionofthetreatmentcourseonday3.Thepatientswereunawareofaneventualhomevisitbythestudyteam.Compliancewasascertainedthroughtheadministrationofasemi-structuredquestionnaire（AppendixA）tothepatientorcaregiverandalsothroughaphysicalinspectionofthesachetwherepossible.Thepatientswerethenclassifiedintorespectivecompliancecategoriesbasedontheassessment.

4.2StudySites

ThestudywascarriedoutinsevenRollBackMalaria（RBM）districtswhereCoartem®hasbeeninuse.Thedistrictswerepurposivelychosenbasedonthefollowingcriteria:

Rural,peri-urbanandurban,partoftheRBMsentineldistrictandeaseofaccessibilityduringtherainyseason.Thesites（districts）chosenwereChongwe,Chibombo,Kabweurban,Kalomo,Livingstone,SenangaandNdola（namesites）.

4.3StudyPopulation

ThestudypopulationconsistedofanypatientsuspectedofhavinguncomplicatedPlasmodiumfalciparummalariapresentingatthehealthfacilityduringnormalOPDhoursinthemonthofJanuaryandFebruary2005for21days（actualdates）.Thediagnosisofmalariawasconfirmed（wherepossible）bylaboratoryinvestigation.Otherfacilitieswithoutlaboratorycapacitybasedtheirtreatmentonclinicalinvestigationsaspermalariacasemanagementguidelines.Patientsdevelopingseveremalariasymptomsandthosenon-residentsinthestudyareawereexcludedfromthestudy.

4.4SampleSize

Anon-compliancelevelof35%wasassumedbasedonearlierresultsfromastudydonein2004.Forthepurposeofthestudyaprecisionof5%and95%confidencelevelwasusedmeaningthataminimumof87patientshadtobeenrolledpersite.Allowingfora20%dropoutrate,atleast104wererequiredtoobtainrepresentativedata.Thusatotalof736patientswereenrolledinthestudy.

4.5StudyProcedure

Upondiagnosisofuncomplicatedmalaria（clinicalorlaboratory）consentwasfirstobtainedfromeverypatientorcaregiverforenrolmentinthestudy.Aminimumofonepatientorcaregiverexitinterviewwasconductedeveryday.Theexitinterviewcorrespondedwiththeblindedobservationofthehealthworkersprovidinginformationondruguseandthiswasmatcedduringanalysis.Onthefirstandseconddays,theOPDbookswerecrosscheckedtodetectifanyofthepatientsonthestudyreturnedtotheclinicaftertakingthefirstdose.Patientsadmittedtothehealthfacilitiesbetweenday0andday3wereexcludedfromthestudy.

OnDay3ofbeingonthestudy,everypatientenrolledwasfollowedupbyaCommunityHealthWorker（CHW）andasupervisortoadministerasemi-structuredquestionnaire（AppendixA）andtoinspectthemedicationpackforanyremainingtablets.Fortheunder-agepatients,thecaregiverwhoaccompaniedthemtotheclinicwastheprimaryrespondenttothequestionnaire.Clinicalconditionassessmentwasdonebymeasuringauxiliarytemperature,withfeverbeingdefinedastemperatureexceeding37.5oC.Ifonday3,thepatient’sconditionhadnotimproved,areferraltothehealthcentrewasmadeandwherenecessary,patientswerereferredtoahospitalnearbytoreceivealternativetreatment.Compliancewasdeterminedandclassifiedintotherespectivecategorydependingonresponsesgiven.

AseparatequestionnairewasalsoadministeredrandomlytopatientswhohadbeentreatedwithCoartem®toassesstheoccurrenceofadversereactions（AppendixE）.Thesamequestionnairewasusedtoevaluatehealthworkerandcommunityperspectivesondrugsafety.

5.0EndPoints

TheprimaryendpointwascomplianceonDay3,measuredthroughtheuseofasemi-structuredquestionnaire,apillcountandablisterpackrecoverywherepossible.Secondaryendpointswerethenumberofdosescorrectlytaken,numberoftabletsremainingintheblisterpack（whereapplicable）developmentofadversedrugreactionsandlosstofollow-up.

6.0ClassificationofCompliance

Intheabsenceofstandardnationalguidelinesonmeasurementofcompliance,thefollowingclassificationwasadoptedforthepurposeofthisstudy:

6.1TotalComplianceAssumed

Verbalconfirmationofcompletionofalldosesinthepresenceofphysicalevidence（emptyblisterpack）andacorrectdescriptionofhowthedosesweretaken.

6.2ProbableComplianceDetermined

Confirmationofcompletionofalldosesintheabsenceofphysicalevidence（blisterpack）andcorrectdescriptionofhowthedosesweretaken.

6.3Non-Compliant

Presenceoftabletsontheblisterpackonday3andinabilitytoexplainhowthedosesweresupposedtobetaken.

6.4NotDetermined

Losstofollow-up,exclusionduetothedevelopmentofseveremalariaoradversedrugreactions.

7.0EthicalConsideration

ThestudywasapprovedbytheCentralBoardofHealth.Healthfacilityconsentwasobtainedfromthein-chargeinordertoaccessthemalariaoutpatientattendancestofacilitatethesamplingofpatientsforeachday.Consen