AdverseEventReporting

This domain contains the concepts needed to produce and send a report concerning a Product Safety-related event (which includes unexpected reactions to a medication) to a jurisdictional entity (i.e., FDA or CDC). This domain is closely aligned with the HL7 Individual Case Safety Report (ICSR) standard. ICSR models the superset of concepts needed for the FDA Medwatch and VAERS reports, but does not include non-drug products (such as medical devices, cosmetics, or food supplements) and does not deal with non-human applications (e.g., veterinary medicine). We intend to add structures for these concepts at a later date.

Adverse Event Reporting is considered a kind of Public Health Report, so we expect a hierarchy from Public Health Report to Product-Related Adverse Events to specific kinds of reports such as the Medwatch reports. Other kinds of adverse events will likely also be reportable and will have other characteristics. For now, we are concentrating on the Product-Related Adverse Events.

Eventually, this domain will be constrained such that specific reports such as the MedWatch 3500 can be specified. The effort to do so has been postponed while related work is being conducted within the Structured Data Initiative. When that work is done, we expect to re-visit this domain. At that time separate sub-packages will be created for various types of reports such as the MedWatch 3500 and the VAERS-1.

AdverseEventReporting
Dependency Polyline coordinates describing hotspot on the image Dependency Polyline coordinates describing hotspot on the image Dependency Polyline coordinates describing hotspot on the image labTest Property labTest Property labTest labTest Property Property Association Polyline coordinates describing hotspot on the image relevantLabTest Property relevantLabTest Property relevantLabTest relevantLabTest Property Property Association Polyline coordinates describing hotspot on the image Dependency Polyline coordinates describing hotspot on the image Dependency Polyline coordinates describing hotspot on the image pharmaceuticalProduct Property pharmaceuticalProduct Property pharmaceuticalProduct pharmaceuticalProduct Property Property Association Polyline coordinates describing hotspot on the image genericMedicine product genericMedicine product genericMedicine genericMedicine product product medicinalproduct__genericMedicine Polyline coordinates describing hotspot on the image manufacturingLot Property manufacturingLot Property manufacturingLot manufacturingLot Property Property medicinalProductInstance_manufacturingLot Polyline coordinates describing hotspot on the image medicinalProductInstance Property medicinalProductInstance Property medicinalProductInstance medicinalProductInstance Property Property suspectedMedicinalProduct_medicinalProductInstance Polyline coordinates describing hotspot on the image productInstance packagedMedicinalProduct productInstance packagedMedicinalProduct productInstance productInstance packagedMedicinalProduct packagedMedicinalProduct packagedMedicinalProduct_productInstance Polyline coordinates describing hotspot on the image reprocessor Property reprocessor Property reprocessor reprocessor Property Property deviceInstance_reprocessor Polyline coordinates describing hotspot on the image Dependency Polyline coordinates describing hotspot on the image deviceInstance Property deviceInstance Property deviceInstance deviceInstance Property Property suspectedDevice_deviceInstance Polyline coordinates describing hotspot on the image deviceObservation Property deviceObservation Property deviceObservation deviceObservation Property Property Association Polyline coordinates describing hotspot on the image drugIngredient Property drugIngredient Property drugIngredient drugIngredient Property Property Association Polyline coordinates describing hotspot on the image drugObservation Property drugObservation Property drugObservation drugObservation Property Property Association Polyline coordinates describing hotspot on the image drugDosage Property drugDosage Property drugDosage drugDosage Property Property Association Polyline coordinates describing hotspot on the image medicinalProduct Property medicinalProduct Property medicinalProduct medicinalProduct Property Property concommittantDrugs_medicinalProduct Polyline coordinates describing hotspot on the image productRole Property productRole Property productRole productRole Property Property Association Polyline coordinates describing hotspot on the image productEventRelationship Property productEventRelationship Property productEventRelationship productEventRelationship Property Property Association Polyline coordinates describing hotspot on the image productEventAssessment Property productEventAssessment Property productEventAssessment productEventAssessment Property Property Association Polyline coordinates describing hotspot on the image reactionOrEvent Property reactionOrEvent Property reactionOrEvent reactionOrEvent Property Property Association Polyline coordinates describing hotspot on the image ingredientSubstance Property ingredientSubstance Property ingredientSubstance ingredientSubstance Property Property drugIngredient_ingredient Polyline coordinates describing hotspot on the image ingredient medicinalProduct ingredient medicinalProduct ingredient ingredient medicinalProduct medicinalProduct medicinalproduct_ingredient Polyline coordinates describing hotspot on the image deviceInstance device deviceInstance device deviceInstance deviceInstance device device device_deviceInstance Polyline coordinates describing hotspot on the image packagedMedicinalProduct medicinalProduct packagedMedicinalProduct medicinalProduct packagedMedicinalProduct packagedMedicinalProduct medicinalProduct medicinalProduct medicinalProduct_packagedMedicinalProduct Polyline coordinates describing hotspot on the image manufacturingLot Property manufacturingLot Property manufacturingLot manufacturingLot Property Property deviceInstance_manufacturingLot Polyline coordinates describing hotspot on the image reactionOrEvent Property reactionOrEvent Property reactionOrEvent reactionOrEvent Property Property Association Polyline coordinates describing hotspot on the image lastMenstrualPeriodObservation Property lastMenstrualPeriodObservation Property lastMenstrualPeriodObservation lastMenstrualPeriodObservation Property Property Association Polyline coordinates describing hotspot on the image Generalization Polyline coordinates describing hotspot on the image Generalization Polyline coordinates describing hotspot on the image reportSubjectObservation Property reportSubjectObservation Property reportSubjectObservation reportSubjectObservation Property Property indvidualCaseSafetyReport_reportSubjectObservation Polyline coordinates describing hotspot on the image heightObservation Property heightObservation Property heightObservation heightObservation Property Property indvidualCaseSafetyReport_heightObservation Polyline coordinates describing hotspot on the image weightObservation Property weightObservation Property weightObservation weightObservation Property Property indvidualCaseSafetyReport_weightObservation Polyline coordinates describing hotspot on the image relevantPastDrugHistory Property relevantPastDrugHistory Property relevantPastDrugHistory relevantPastDrugHistory Property Property Association Polyline coordinates describing hotspot on the image releventMedicalHistory Property releventMedicalHistory Property releventMedicalHistory releventMedicalHistory Property Property Association Polyline coordinates describing hotspot on the image relatedPersonObservation Property relatedPersonObservation Property relatedPersonObservation relatedPersonObservation Property Property Association Polyline coordinates describing hotspot on the image medicationList Property medicationList Property medicationList medicationList Property Property Association Polyline coordinates describing hotspot on the image healthConcern Property healthConcern Property healthConcern healthConcern Property Property Association Polyline coordinates describing hotspot on the image reportSubject Property reportSubject Property reportSubject reportSubject Property Property notificationReport_reportSubject Polyline coordinates describing hotspot on the image study Property study Property study study Property Property indvidualCaseSafetyReport_study Polyline coordinates describing hotspot on the image literatureReference Property literatureReference Property literatureReference literatureReference Property Property indvidualCaseSafetyReport_literatureReference Polyline coordinates describing hotspot on the image sender Property sender Property sender sender Property Property indvidualCaseSafetyReport_sender Polyline coordinates describing hotspot on the image informationReporter Property informationReporter Property informationReporter informationReporter Property Property indvidualCaseSafetyReport_informationReporter Polyline coordinates describing hotspot on the image otherCaseIdentifier Property otherCaseIdentifier Property otherCaseIdentifier otherCaseIdentifier Property Property indvidualCaseSafetyReport_otherCaseIdentifier Polyline coordinates describing hotspot on the image documentsHeldBySender Property documentsHeldBySender Property documentsHeldBySender documentsHeldBySender Property Property indvidualCaseSafetyReport_documentsHeldBySender Polyline coordinates describing hotspot on the image Generalization Polyline coordinates describing hotspot on the image notificationReport_notificationReportCategory Polyline coordinates describing hotspot on the image suspect concomitant enumProductRole other layUserOrPatient healthProfessional enumDeviceOperator sibling father mother enumRelationship isMoreInfoAvailable comment RelevantLabResult userFacility manufacturer distributorOrImporter enumReportedTo ReturnedToMfr No Yes enumProductAvailabiltiy name code GenericMedicine unitPrice storageCondition id MedicinalProductInstance id Reprocessor requiredIntervention otherImportantCondition congenitalAnomalyOrBirthDefect disablingOrIncapacitating causedOrProlongedHospitalization lifeThreatening resultedInDeath enumAESeriousness wasSingleUseReprocessed therapyStopDate therapyStartDate otherUserText deviceOperator dateExplanted dateImplanted DeviceObservation sig nbrOfPreviousDoses lastFillDate indHolderName indHolderCountry didReappear didEventAbate DrugObservation productRole productNameReported isBlinded isAvailableForEvaluation indicationText indication gestationalAgeAtExposure dateReturnedToMfr cumulativeDose countryWhereObtained additionalInformationText additionalInformationCoded actionTaken ProductRole source result method ProductEventAssessment timeFromAdminStop timeFromAdminStart didReactionRecur ProductEventRelationship stopDate startDate routeText route parentRouteText parentRoute frequency duration drugFormText dose dosageText DrugDosage kind Substance quantity isPreservative isDiluent isConfidential isAdjuvant isAntigen isActiveMoiety effectiveTime DrugIngredient version name modelName modelId commonDeviceName cataloglId Device newDrugApplicationId isOverTheCounter investigationalNewDrugId controlledSubstanceSchedule auxilliaryLabel MedicinalProduct packageType packageCapacity nationalDrugCode name description codeModifier code capType PackagedMedicinalProduct lotSize lotId expirationDate ManufacturingLot wasConfirmedByMedicalProfessional startDate seriousness reactionOrEventType outcomeAtLastObservation endDate duration descriptionTranslation descriptionLanguage descriptionInNativeLanguage countryOfOccurrence adverseEventSeriousness ReactionOrEvent value observedCharacteristic LastMenstrualPeriodObservation sex releventMedicalHistoryText race initials dateOfBirth ageAtOnset AbstractReportSubjectObservation reportedCauseOfDeathText reportedCauseOfDeath gestationalAgeAtOnset dateOfDeath autopsyDeterminedCauseOfDeathText autopsyDeterminedCauseOfDeath ageGroup ReportSubjectObservation relationshipCategory name RelatedPersonObservation MedicationList previousReaction indication RelevantPastDrugHistory isContinuing comments ReleventMedicalHistory url status safety softwareName note localRemoteControlState id dateManufactured dateLastCalibrated dateDisposed dateAcquired contact alertLevel DeviceInstance HeightObservation status patientId mothersIdentifier endDate beginDate Patient sponsorsStudyId name id category Study name content LiteratureReference email fax isPrimarySource category phone address departmentName organizationName name Sender alsoReportedTo doNotDiscloseIdentity occupation phone email address qualification organizationName name isHealthProfessional isPrimarySource departmentName ICRRInformationReporter caseIdSource caseId OtherCaseIdentifier description content DocumentsHeldBySender ReportableResult wasReadministered wasDueToPtCondition wasAdminStopped adverseReactionLikelihood _parkinglot_SuspectedProduct FDAMedwatch3500 FDAMedwatch3500 WeightObservation wereOtherCaseIdsUsed wasAutopsyPerformed uniqueCaseId sendersDiagnosis sendersComments reportersComments relatedReportId originalSenderCategory nullificationOrAmendmentReason meetsExpeditedCriteria icsrReportCategory descriptionOfEvent dateReportFirstReceived dateOfMostRecentInfo caseSummaryLanguage caseSummaryInNativeLanguage caseSummary areAdditionalDocumentsAvailable IndvidualCaseSafetyReport Comment author status category informationAvailableDateTime eventDateTime dateReported id primaryPerformer _parkinglot_PatientSafetyInvestigation zAdverseEventOutcome zdidInitalReporterSendToFda dateOfEvent _parkinglot_ProductRelatedAdverseEventReport HealthConcern etc PublicHealthCase PublicHealthExposure PublicHealthEvent Outbreak HospitalAcquiredInfection AdverseReaction NotificationReportCategory status sendingSystem reportingSystem reportId reportDateTime reportCategory moreInformationlProvider careGiver alertDateTime NotificationReport

Classifiers

Diagrams

Properties:

Alias
Keywords
NameAdverseEventReporting
Name Expression
NamespaceFHIM
Nesting PackageFHIM
Owned Template Signature
OwnerFHIM
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting
Stereotype
Template Parameter
VisibilityPublic