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-171450-88455500HL7 RCRIM WGFHIR AdverseEvent ResourceCALL MINUTES: Friday, December 9, 2016Meet online at , meeting number: 196 412 889Phone +1 770-657-9270, passcode 7485962Attendees: ##PresentNameEmailAffiliationBehnaz Minaei Behnaz.Minaei@fda.FDABrian Peck bpeck@EPICClaude Nanjo cnanjo@Daniela VancoDaniela.Vanco@FDADavid PettieSimon Fraser University Ed Hammond PhD william.hammond@duke.eduDukeEdward Helton (NIH/NCI) heltone2@mail.NIHXElaine Ayres (NIH/CC/OD) EAyres@cc.NIHGary SanerReed TechnologiesHojjat SalamasianHos7004@New York PresbyterianIona?Thraen?ithraen@VA/Dept of Health UtahJames Swiger FDAXJaya Kaja, Ph.D.IBM Watson SolutionsJose Costa Teixeira jose.a.teixeira@Jose GalvezNIHJulie EvansSamvit SolutionsJulie James julie_james@bluewaveinformatics.co.ukBlue Wave InformaticsKaren Zimmerkpzimmer@Konstadinos Kidos konstadinos.kidos@BaxaltaM’Lynda Owens Mlynda.Owens@CognosanteMary Ann SlackMaryann.slack@fda.FDAMead Walker dmead@Mead Walker ConsultingXMitra Rocca mitra.rocca@fda.FDAPooja BabbrahPooja.Babbrah@Point of Care PartnersXRashad HasanFDARaymond Kassekert raymond.x.kassekert@GSKXRik Smithies rik@nprogram.co.ukHL7 UKRobert MouraXSheila Connelly sconnelly@Technical Talent ResourceSmita HastakNCIStella Stergiopoulosstella.stergiopoulos@tufts.eduTufts UniversityXSuranjan DeSuranjan.De@fda.FDASusan Terrillion (AHRQ/CQuIPS) (CTR) Susan.Terrillion@AHRQ.AHRQXTa Jen ChenTa Jen Chen@fda.FDAThomas Felixthfelix@AMGENTerrie ReedFDATony SchuethTony.Schueth@Point of Care PartnersWayne Kubickwkubick@CTO HL7William Friggle William.Friggle@SanofiWilliam Gregory William.Gregory@PfizerProject Wiki the FDA Acronyms & Abbreviations Database: Conformance Rules: 1.12.2 CardinalityAgendaApprove minutes from the November 18th?meeting: discussion of adverse reaction and options for representing an adverse reaction.Discuss issue of causality.Review “DetectIssue” resource and relationship to adverse event:? agenda for Wednesday Q3 RCRIM Adverse Event resource meeting.Next Meeting:? December 16.? (No meeting on December 23 or December 30). Last meeting before San Antonio WG will be Friday, January 6. San Antonio WG meeting: Wednesday Q3 MinutesApprove minutes:November 18, 2016Move: Mitra/SheilaPrior Discussion of Adverse ReactionHow to represent an adverse reaction.There are several options available for the representation of an adverse reaction within the context of an adverse event:Reference the observation resourceInclude the data elements for an adverse reaction within the adverse event resourceSupport the development of separating the adverse reaction data elements from the current allergy and intolerance resourceThe group agreed that is was not appropriate to point to the allergy and intolerance resource for the purpose of using the adverse reaction data elements as they are too constrained.Key Data Elements needed for Adverse ReactionLook at original adverse reaction resourceLooked at the current Condition resource - some of the data elements needed are included and provide a good model of parts of the adverse reaction requirementsDetermine key data elements required for adverse reactionDate/timeReactionSeverityMotion: Separate adverse reaction from the allergy and intolerance resource Move Rik/Mitra Abstain – 0, Negatives – 0 Approve – 7C-CDA ballot as a FHIR resource. Check adverse ReactionCausality and how to describeKey data elementsE2B – may not rely on this from manufacturersHealth care provider can provide on Medwatch formIssue with concomitant meds – could be a one to many Linking class – with certaintyQuestion using info on label – stated on not statedCite label as evidenceFDA uses these events as evidence for the label.Terminology for causality -- ? MeDra (no) or WHO? in V3 RIM From ICH E2BSource of AssessmentThis data element indicates the source of the assessment provided.? (for example, reporter, company)Method of AssessmentThis data element indicates the method of the assessment provided .(For example global introspection, algorithm, Bayesian calculation, etc.)Result of AssessmentThis data element captures the result of the assessment for relatedness.The ‘value’ will depend on the method used for the assessment. (for example - Related, Possible Related, or 0.76 if calculated)Reviewed the ‘Detected Issue” resource: . The “Detected Issue” Resource has the following description:This resource applies to various circumstances where there is a concern about an existing or proposed set of clinical activity. The issue could relate to single, proposed, or multiple actions. It does not apply to technical issues (e.g. lack of user permissions) but could relate to violation of patient consent limitations. Examples include: Drug-drug interactionsInappropriate therapy (wrong dose, frequency, body site)Duplicate therapyThis resource represents a specific instance of a potential issue for a particular patientThe group agreed that the Adverse Event resource should reference the Detected Issue resource and vice versa. San AntonioE2B R3 implementation vs. this FHIR resourceCIC – DAM Generalized Anxiety DisorderBRIDGEvent Resource guidanceUse Case listAdverse Event Drug* BiologicDevice*Vaccine Medical Food* Dietary Supplement*Herbals Food CosmeticsReporter variationsHealthcare ReportedPatient ReportedManufacturer ReportedVeterinary ReportedSupply ChainMedication Reconciliation*Product Problem (device)*Product Quality (office of pharmaceutical quality)Product Use Error Wrong dose*Package insert error*Wrong technique*Wrong route of administration*Wrong rate*Wrong duration*Wrong time*Expired drug*Problem with use of Medication from Different ManufacturersProtocol Adverse Event with IND Serious Adverse EventUnanticipated Problem* (Consider international terminology)Patient Safety Incident*Patient Safety Near Miss*Patient Safety Unsafe Condition*The next meeting will be held on Friday, December 16 at 10 AM. Outstanding Questions from FMGQuestions and comments from the FHIR Management Group (FMG) related to FHIR AdverseEvent Resource:The scope should include events that happen to individual other than patients. Specifically, Practitioners and RelatedPersonsPossibly also Devices (e.g. equipment damage)For each of the "related resources", can you define what the nature of the relationship is?Reference by name – linksPatient resourceObservation resourceMedication resourcesImmunizationsDevicesNeed to correct and update resource proposal and let Lloyd know. QuestionsnoneAction ItemsAny line items that include explicit actions are highlighted in yellow above.Begin writing resource text in the format used for other FHIR Resources. Example: CallAgenda for Next CallNext call will be on Friday, December 16, 2016 at 10 AM.Approve minutes from December 9, 2016 meetingDiscussionAgenda for next meeting ................
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