FieldInvestigators:

ADEDetectives學(xué)分網(wǎng)SectionOneIntroductiontotheTeamandTheirRolesFDA’sPostmarketingAdverseDrugExperienceInspectionalProgram…”promoteandprotectpublichealthbyassuringthatsafeandeffectivedrugsareavailabletoAmericans.”…”providepharmacovigilanceresourcestotheCenterforDrugEvaluationandResearchtoensurethesafetyofmarketeddrugs.”

FieldInvestigations

OfficeofDrugSafety

OfficeofCompliance

RegulatoryPolicyStaff

OfficeofChiefCounsel…”serveasindustrywatchdog,performinginspectionsorinvestigationsthathelpprotectthesafetyofallourcitizens.”

Afterapproval,drugsareusedinmany

typesofpatients--includingolder,sicker

orthosetakingmedications---

thatwerenotstudiedduringthepre-approval

period.

Rare,seriousadversereactionsareoften

notdiscovereduntilmanythousands

ofpatientshavetakenthedrug.

Labelingchangesrelatedtoprescribing

informationarecompleteandup-to-date.

Drugrisksarequicklyandappropriately

managed.

Regulations

Guidance

Informationonhowtoconductan

inspection

HelpfultipsandinformationSectionTwoTheRegulationsSafetyreportingrequirements

coverallpersonswhomarket

over-the-counterdrugswith

approvedapplicationsand

prescriptionsdrugs

Applicants

Manufacturers

Packers

Distributors

Title21oftheCodeofFederalRegulationsSection314.80-PostmarketingSafety

ReportingRegulationsforHumanDrugs

withApprovedNewDrugApplicationsSection314.98-PostmarketingSafety

ReportingRegulationsforHumanDrugs

withApprovedAbbreviatedNewDrug

ApplicationsSection211.198-RequiresIndustry

toEstablishWrittenProceduresfor

HandlingComplaints,IncludingADEs

Anadverseevent

occurringinthecourseof

theuseofadrugproductin

professionalpractice;

fromadrugoverdose,whether

accidentalorintentional;

fromdrugabuse;

fromdrugwithdrawal;

andfromanyfailureofexpected

pharmacologicalaction

Death

Alife-threateningADE

Inpatienthospitalizationor

prolongationofexisting

hospitalization

Apersistentorsignificantdisability

orincapacity

Acongenitalanomalyorbirthdefect

Otherimportantmedicalevents

Whatmustbereported?

Anyspontaneousadverseevent

occurringwithintheU.S.

Anyforeignreports,literatureand

studyreportsthatinvolveserious

andunexpectedevents.3TypesofRequiredReports?

Expeditedor15-dayalertreports

Periodicreports

Follow-upreportsFourBasicElements:

identifiablepatient

Identifiablereporter

Suspectdrug

Anadverseexperienceorfatal

outcomeForm3500AorCIOMS1Form-From

thecouncilforInternationalOrganizations

ofMedicalSciences

Surveillance

Receipt

Evaluation

Reporting

Firmsshouldcollect

qualityinformation

Identifyandconfirmdrug

safetyissuesassoonaspossible

Communicatedrugsafety

informationtoFDAandtothe

publicefficientlyandeffectively

MaintainallADErecords,including

allrawdata,for10years

/medwatch/how.htm

ByMail:Usethepostage-paid

MedWatchform

ByPhone:1-800-FDA-1088

ByFAX:1-800-FDA-0178

AndbyInternetSectionThreeComplianceProgramGuidanceYourjobasaninvestigatorwilldependmore

oncomputersandtelecommunications.TypesofInspections:

For-causeordirectedinspections

RoutinesurveillanceinspectionsSelectionCriteria:

AreviewoftheAdverseEventReporting

Systemdatabase

Firmsthathaveahistoryofviolations,are

ontheApplicationIntegrityPolicyList,or

thathaveahistoryofrecalls

Routinesurveillance

ThedrugisanewmolecularentityorIson

theTOP200List

SelectionCriteria:

Safetyissues

Bioequivalenceissuesand

Specialsituations

Timelinessreports

Directreportsvs.Mandatoryreports

Completenessreports

GettingReadyforanInspectionReviewpreviousestablishmentinspectionreportsReviewinformationprovidedwiththeassignment,

whichmayinclude3500Aforms,current

approvedlabelingandAERS-generatedADElistsReviewapplicableCFRsections,Compliance

ProgramInformation,andFDAguidelinesContactthestaffmemberwhoinitiatedyour

assignment

Allofthefirm’swrittenproceduresthatdescribe

receipt,evaluation,andsubmissionsofADEs

duringthetimeperiodunderinvestigation.

Organizationalchartsshowingwhichpersonswere

orareresponsibleforallcomplianthandlingduring

thetimeperiodunderinvestigation.

Allwrittenproceduresdescribingwhoisresponsible

forchangingcomplainthandlingproceduresduring

thetimeperiodunderinvestigation.

Allcorrespondence,meetingminutes,anddocuments

relatingtoallADEs.

Listofallthecompany’sdrugproductsandapproval

dates.

Packageinsertsforproductscoveredunderthe

inspection.

AlistingofallADEcomplaintsreceivedoveraspecific

timeframe,suchas2years,includingforeignand

domesticevents.

Periodicreports,specific3500Aforms,andassociated

rawdata.

Listsofcollectionsites,processingcenters,and

reportingunits.

Copiesofallcontractualagreementsrelatedtocollection,

evaluationandreportingADEs.SectionFourHowtoConductanInspectionIsthereadifferencebetweenaGMPinspection

andapost-marketingADEinspection?WhatisthemainobjectiveoftheseADE

inspections?Whataresomethequestionsyoutypicallyask

whileinterviewingrepresentativesofthe

company?

Howdotheydotheirjobwheneachtypeof

ADEcomesintothecompany?

AretheremeetingsonADEs?Whopresides;

howoften;whattopicsarediscussed?

Whichpersonsinthecompanyareresponsible

forlabelingandmakingsurethelabelingreflects

theADEscomingintothecompany?

Howdoestheprocessworkforassuring

labelingreflectsADEs?

Whofirstreceivestheincomingmailorcalls

relatingtoADEs?

WhereareandhowareADEsloggedin?

Whoperformsthemedicalevaluations?

Whoperformsfollow-up?

Whoassessesseriousness?

WhodeterminesiftheADEisalabeledoran

unlabeledevent?

WhodeterminesiftheADEisa15-dayora

periodicreport?

Whotransmitsorsendsthe3500AFormtoFDA?

Howisinformationsharedamong

departments?Beawarethatthelegal

departmentmightbereceivingandmaintaining

ADEstoo.

WhodeterminesiftheADEisalabeledoran

unlabeledevent?

HowareADEstracked?

Howarecontrolnumbersassigned?

Doesthefirmuseacomputerizeddatabasefor

tracking

Isthisdatabasenationalorglobal?What

informationiskeptinthedatabase?

Isthereanaudittrail?Howdoesthe