10-Assessment of AR Case Report Final 2007-07-13

CanadaVigilanceProgram:AssessmentOfAdverseReactionCaseReportsStateFoodandDrugAdministration–ChinaAugust2007HeatherSutcliffeDirector,MarketedHealthProductsSafetyandEffectivenessInformationBureau(MHPSEIB)MarketedHealthProductsDirectorateHealthProductsandFoodBranchHealthCanada2MarketedHealthProductsSafetyandEffectivenessInformationBureau•25Staff+8Regionalcoordinators+(students)•Responsibleforthecollectionandassessmentofadversereaction(AR)reportssubmittedbyMarketAuthorizationHolders(MAHs),HealthCareProfessionals,andConsumers.•ARreportsincludespontaneous,solicited,post-marketstudiesandphaseIVclinicaltrials,literaturecases3HealthCanada’sAdverseReaction(AR)ReportingGuidelinesVoluntary•VoluntaryreportinginformationisavailableintheGuidelinesfortheVoluntaryReportingofSuspectedAdverseDrugReactionstoHealthProductsbyHealthProfessionalsandConsumers•GuidelinesfortheCanadianPharmaceuticalIndustryonReportingAdverseReactionstoMarketedDrugs(vaccinesexcluded):•ICHE2D:Post-approvalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting•ReportoftheCouncilforInternationalOrganizationsofMedicalSciences(CIOMS)VWorkingGroup:CurrentchallengesinPharmacovigilance:PragmaticApproaches•PostedforconsultationOctober2006•RevisedVersionwillbepostedFall2007://hc-sc.gc.ca/dhp-mps/medeff/report-declaration/guide/consult_guide-ldir_indust_f.html5ICHPost-Market•ICHE2B–DataElementsforTransmissionofIndividualCaseSafetyReports•ICHE2C–PeriodicSafetyUpdateReports(PSUR)forMarketedDrugs•ICHE2D–DefinitionsandStandardsforExpeditedReporting•ICHE2E–PharmacovigilancePlanning•MedDRA–MedicalDictionaryforRegulatoryActivitiesTerminology6ICHE2B•StandardizethedataelementsforthetransmissionofIndividualCaseSafetyReports(ARReports)•ElectroniccommunicationofARReportinformation•Facilitatesexchangeofinformation,whereARinformationissharedbetweenmultiplerecipientsasperregulatoryobligation,andinternationalagreements•Pre-andpost-marketperiodsforreportingofadversereactions7RegulatoryDefinitions•AdverseDrugReaction(ADR):Anoxiousandunintendedresponsetoadrugwhichoccursatdosesnormallyusedortestedforthediagnosis,treatmentorpreventionofadisease,orthemodificationofanorganicfunction.•AdverseEvent:Anyuntowardmedicaloccurrenceduringtreatmentwithapharmaceuticalproductbutthatdoesnotnecessarilyhaveacausalrelationship.*FoodandDrugRegulations,PartC,Division18RegulatoryDefinitions•SeriousADR:Anoxiousandunintendedresponsetoadrug,whichoccursatanydoseandrequiresin-patienthospitalizationorprolongationofexistinghospitalization,causescongenitalmalformation,resultsinpersistentorsignificantdisabilityorincapacity,islife-threateningorresultsindeath.(Othermedicallyimportantcondition:interventiontopreventoneoftheaboveoutcomes;convulsions;blooddyscrasias;drugabuse/dependence.)•Serious,UnexpectedADR:aseriousadversedrugreactionthatisnotidentifiedinnature,severityorfrequency*FoodandDrugRegulations,PartC,Division19AnnualARReportStatistics2006•10,518newdomesticreports(67%serious)-pharmacists(25%)-consumers(22%)-physicians(28%)-nurses(9%)-healthprofessionals(12%)•SourceofCanadianreports:Manufacturers,66%;RegionalARCentres,32%•252493foreignmanufacturerreports(initialplusfollow-up)–countedandfiledalphabeticallybyMAH–notenteredintoCanadianAdverseDrugReactionInformationSystem(CADRIS)database•domesticinitial&follow-upreports:1454910ARReports•4Minimumcriteria–patient,reporter,reaction,suspectproduct(voluntaryormandatoryreports)•Tradenamesarenotalwaysprovided•Reportersencouragedtogivefulldetailsofrelevantconcomitantdiseaseandtherapytoallowcausalityassessment11ProcessingARreports•Receivedbymail,courier,fax,phone,email,onlinee-form•Datestamped,counted,Canadianseparatedfromforeign•ScreeningofeachCanadianreport:–Reportsforpriorityprocessing–Misdirected/unenterablereports–Reportsforattn:toanothergroupatHC•EntereddailyintoAdverseEventTrackingDatabase•EnteredintoCADRIS•Follow-ups-Joinedtoinitialreport•FiledandlatersenttoCentralRegistry(CR)•MHPSEIB-officialrepositoryforARreports12ARReportAssessmentbyARSpecialistsElementsofARreportidentifiedbySpecialist:•Roleofthehealthproductasreported:suspected,concomitant,other,treatment,interacting(SCOTI)•Outcome:unknown,recovered,notyetrecovered,recoveredwithsequelae,died•Serious,reasonforserious–asperregulatorydefinition•AssignsreactiontermsfromWHOARTterminologytocapturetheinformationasdescribedonthereport.•Overallassessmentwithrespecttosignaldetection.13WHOQualityReportGradingProcessCase-ID,Country,Drug,ReactionYes↓Grade=0Age,genderYes↓Grade=1OnsetofreactionandtreatmentdatesYes↓Grade=2PatientOutcomeYes↓Grade=3DrugdosageYes↓Grade=4RouteofAdministrationYesGrade5No→ReportRejectedNo→Reportremainsgrade0No→Reportremainsgrade1No→Reportremainsgrade2No→Reportremainsgra