Adverse Events and Risk Management_26 May 2011.pdf

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    ADVERSEEVENTSandRISK

    MANAGEMENT

    NoraBucko

    [email protected]

    Objectives

    Introduction

    Definitions

    Causality

    Coding

    DataCollection

    Responsibilities

    Clinicaltrialreporting

    timeframes

    Postmarketing

    reportingtimeframes

    CaseStudy

    GilenyaTM

    RiskManagement

    Introduction

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    Introduction

    GoalsofDrugSafety:

    Minimizeharmtopatients

    Understandthemedicaltoxicityofthe

    product

    Establishbenefit/riskratio

    Introduction

    Adrugisconsideredsafewhenitsrisks

    havebeenidentifiedandarejudgedto

    beacceptable(whenweighedagainstthepotentialbenefit).

    Introduction

    ContinuousAssessmentofRisk

    Preclinical----singleandrepeatdosetoxicityinanimals(mutagenicity,

    carcinogenicity,reproductivestudies) Clinical

    PhaseI:Safetyinhumans PhaseIIandIII:EfficacyandSafety PhaseIV:Longtermsafety,safetyinspecialpopulations(pediatricandgeriatricpatients)

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    DefinitionsDefinitionsDefinitionsDefinitions

    DefinitionsDefinitionsDefinitionsDefinitions

    Consistentstandardsanddefinitionsarerequiredinorderto:

    accuratelyandeffectivelyanalyzesafety

    data

    meetworldwideregulatoryreporting

    requirementsforadverseeventsduring

    clinicaldevelopment

    DefinitionsDefinitionsDefinitionsDefinitions

    AdverseEventAdverseEventAdverseEventAdverseEvent:anyuntowardmedical

    occurrence(includingsignificantabnormal

    laboratoryfindings),symptomordisease

    temporallyassociatedwiththeuseofstudy

    drugtreatmentduringaclinicalstudy,

    whetherornotconsideredrelatedtotheuseof

    studytreatment.

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    Definitions

    AdverseDrugReaction:AdverseDrugReaction:AdverseDrugReaction:AdverseDrugReaction: allnoxiousandunintendedresponsestoa

    medicinalproductrelatedtoanydose

    shouldbeconsideredadversedrug

    reactions

    whereresponsestoamedicinalproductmeans

    thereisareasonablepossibilitythatthedrugcausedtheevent

    Definitions

    SeriousAdverseEvent:SeriousAdverseEvent:SeriousAdverseEvent:SeriousAdverseEvent: Anyadversedrugexperienceoccurringatanydosethatresultsinanyofthefollowingoutcomes: Death

    Life-threateningadversedrugexperience

    Inpatienthospitalizationorprolongationof

    existinghospitalization

    Definitions

    SeriousAdverseEventSeriousAdverseEventSeriousAdverseEventSeriousAdverseEvent

    Apersistentorsignificantdisability/incapacity

    Acongenitalanomaly/birthdefect

    Importanteventsthatmaynotresultinthe

    above,butbasedonmedicaljudgment,they

    mayrequiremedicalorsurgicalintervention

    topreventoneoftheoutcomeslistedabove.

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    Definitions

    Unexpected:Unexpected:Unexpected:Unexpected: Notidentifiedininvestigatorsbrochureor

    packageinsert/productlabeling

    Greaterinseverityorspecificitythanas

    describedintheInvestigatorsBrochureor

    Productlabeling

    Definitions

    Causalrelationship:Causalrelationship:Causalrelationship:Causalrelationship:

    Associatedwiththeuseofthedrugmeans

    thereisareasonablepossibilitythatthe

    experiencemayhavebeencausedbythe

    drug

    21CFR312.32

    CausalityCausalityCausalityCausality

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    Causality

    Howtodeterminecausality:

    Isthisaknownreactiontothedrug?

    Isthereatemporalrelationshiptodrug

    administration?

    Aretherealternativeexplanations,e.g.

    procedures,concomitantmedicationsor

    concomitantdiseases?

    Causality

    Factorstoconsider: Positivedechallenge-didsymptomsabate

    (decreaseordisappear)ondosereduction

    ordiscontinuationofdrug?

    Positiverechallenge-didsymptomsrecur

    onreadministrationofdrug?

    CODINGCODINGCODINGCODING

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    Coding

    Standardmedicalterminologywithcodesneededfor:

    Adverseeventusingstandarddictionaries,

    e.g.MEDDRA

    Drugtreatmentandconcomitantmedications

    MedicalHistoryandProcedures

    DataCollectionDataCollectionDataCollectionDataCollection

    DataCollection

    StandardAdverseEvent

    Severity-Mild,Moderate,Severe

    Dates-onset,resolutionorcontinuing

    Frequency-singleormultipleepisodes

    Relationship:Investigatorscausality-likely,definitely,notrelated,possibly,probably,unlikely

    Actiontakenwithstudydrug,treatmentrequired,outcomeofevent

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    ClinicalTrialsClinicalTrialsClinicalTrialsClinicalTrials

    ClinicalTrials

    ReportingTimeframesReportingTimeframesReportingTimeframesReportingTimeframes

    Expeditedreport

    Serious,UnexpectedandAssociated

    7DayPhonecallorFaxtoFDAforLife-

    threateningorFatalReaction

    15CalendarDaysubmitINDSafetyReport

    onMedWatchFormtoFDA

    ClinicalTrials

    RoutineadverseeventsRoutineadverseeventsRoutineadverseeventsRoutineadverseevents RecordedonCRF

    AnnualINDReport

    FinalStudyReport

    Post-MarketingPeriodicReport(includeall

    INDreports)fromclinicaltrials

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    ResponsibilitiesResponsibilitiesResponsibilitiesResponsibilities

    SponsorResponsibilities

    SubmitINDSafetyReporttoFDA

    SendLettertoallInvestigatorsusingstudydrug

    Ifapplicable,updateProtocol,InvestigatorBrochureandInformedConsent

    Consultclinicalexperts

    InvestigatorResponsibilities

    ImmediatelyreportallSAEsto

    Sponsor/CRO,completeSAEform

    InformInstitutionalReviewBoardofSAE.

    RecordalladverseeventsonCRFandin

    patientsmedicalrecord(sourcedocument)

    Medicallymanagepatient(consultsponsor,

    adjuststudydrugdosage,administer

    correctivetreatment)

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    CRAResponsibilities

    TrainsiteinrecognitionandreportingofSeriousAdverseEvents

    Duringmonitoringvisit,ifAEorSAE

    identified,informcoordinator/Investigator

    Requestfollow-upinformation(hospital

    dischargesummaries,autopsy,laboratory

    reports)

    CRAResponsibilities

    Discusssafetytrendsandfindingswith

    InvestigatorandSponsorMedicalDirector

    ReviewSeriousAdverseEventformfor

    accuracyandcompletion

    AlertSponsorRegulatorydepartmentif15

    DayINDreportistobefiled

    FDAActions

    Approvelabelingchanges

    BoxedWarnings

    DearDoctor letter

    Requestadditionalinvestigationand/orclinicaltrials

    ClinicalHold

    Recall

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    PostmarketingPostmarketingPostmarketingPostmarketingPharmcovigilancePharmcovigilancePharmcovigilancePharmcovigilance

    Postmarketing

    Pharmacovigilance

    Spontaneousreportingsystemforevaluationofdrugsafety:

    mandatoryformanufacturers

    voluntaryforhealthcareprofessionalsin

    clinicalpractice

    limitations- nocontrolgroup,nodenominator,

    cannotcalculateincidence

    Postmarketing

    Pharmcovigilance

    Reportingratesofadverseeventsareaffectedbymanyfactors:

    lengthoftimeonmarket initialrateofsale

    unexpectednessofevents

    publicity,media,publication

    solicitation

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    Postmarketing

    Pharmcovigilance

    ReportingTimeframes:ReportingTimeframes:ReportingTimeframes:ReportingTimeframes: Expeditedreporting(15days)ofseriousand

    unexpectedevents;causalityimplied

    QuarterlyperiodicreportstoFDAforfirst3

    yearsofmarketing,thenyearly

    PeriodicSafetyUpdate(PSUR)toEurope

    (EMEA)

    PeriodicReview

    Buildknowledgebaseofdrug

    Compileandreviseproductsafetyprofile

    UpdatesafetysectionofInformedConsent

    UpdateProductlabelingifmarketed

    UpdateInvestigatorsBrochureif

    investigationaldrug

    RiskManagement

    FDAGuidances PremarketingRiskAssessment

    GoodPharmacovigilancePracticesandPharmacoepidemiogicAssessment

    DevelopmentandUseofRiskMinimizationDevelopmentandUseofRiskMinimizationDevelopmentandUseofRiskMinimizationDevelopmentandUseofRiskMinimizationActionPlans(RiskMAP)ActionPlans(RiskMAP)ActionPlans(RiskMAP)ActionPlans(RiskMAP)

    ICHHarmonisedtripartiteguidelineICHE2

    Pharmacovigilanceplanning

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    CaseStudy:GILENYATM

    ThankyouThankyouThankyouThankyou

    QuestionsandAnswersQuestionsandAnswersQuestionsandAnswersQuestionsandAnswers


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