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16/04/2013ICD-9-CM to MedDRAMapping – How Well Do theTwo Terminologies CorrelateAnna Zhao-Wong, MD, PhDDeputy DirectorM dDRA MSSOMedDRADisclaimer The views and opinions expressed in the following PowerPointslides are those of the individual presenter and should not beattributed to Drug Information Association,Association IncInc. (“DIA”)( DIA ), itsdirectors, officers, employees, volunteers, members, chapters,councils, Special Interest Area Communities or affiliates, or anyorganization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of theindividual presenter and are protected under the copyright lawsyof the United States of America and other countries. Used bypermission. All rights reserved. Drug Information Association,Drug Information Association Inc., DIA and DIA logo areregistered trademarks. All other trademarks are the property oftheir respective owners.21
16/04/2013Background ICD-9-CM: The International Classification ofDiseases, Ninth Revision, Clinical Modification MedDRA: Medical Dictionary for RegulatoryActivities3Background (cont) MedDRA ICD-9-CM– Global: Canada, EU,Japan,p , US,, Australia – Regulatory reporting– Pharma company,CRO, regulator,research institute– Drug safetysurveillance, signaldetection, indication,labeling – Five-level hierarchy– 70,000 terms– US-based– Insurance claimclaim,health outcome– Insurance company,healthcare provider,research institute– Morbidity and mortalitystatistics,epidemiologyid i lstudyt d– Three-level hierarchy– 17,000 terms42
16/04/2013Background (cont)ICD-9-CMMedDRA5Health Related MetadataPatient Outcomedatabases (EHR,iinsurance))Drug Safety Databases (FDAAERS, Eudravigilance, CanandaVi ilVigilance,PhPharmacompanies)i )(Coded in ICD, SNOMED,CPT )(Coded in MedDRA)Epidemiology studySafety Signal DetectionSafety surveillance63
16/04/2013Metadata – Cross ReferencePatient Outcomedatabases (EHR,iinsurance))Drug Safety Databases (FDAAERS, Eudravigilance, CanandaVi ilVigilance,PhPharmacompanies)i )(Coded in ICD, SNOMED,CPT )(Coded in MedDRA)Epidemiology studySafety Signal DetectionSafety surveillance7Metadata – Cross Reference (cont) Mapping – provide a bridge to cross walk from oneterminology to another How well does a mapping work?(Level of interoperability) Area of interest: ICD-9-CM to MedDRA mapping84
16/04/2013Source Data Observational Medical Outcomes Partnership(OMOP)– To research methods that are feasible and useful toanalyze existing healthcare databases to identifyand evaluate safety and benefit issues of drugsalready on the market Source– Preliminary mapping from OMOP database v2.0 At MedDRA Preferred Term ( 18,000) level (v12.0) 10% ICD-9-CM terms were not included in the mapping9Mapping Methodology Method of mapping– Microsoft Access queries and manual mapping At MedDRA Lowest Level Term ( 67,000) level All ICD-9-CM terms (3, 4, 5-digit)– Review and verify by qualified personnel(medical and MedDRA knowledge) ICH MedDRA Term Selection: Points To ConsiderGuide105
16/04/2013ICD-9-CM to MedDRA Mapping (cont) To measure how well the match is– Each pair of ICD-9-CMICD 9 CM term and MedDRA LLTis categorized Complete confidence (perfect match): the concept ofICD-9-CM term is accurately represented by themapped LLT RRelativel ti confidencefid(No(N lossloff information):i fti ) ththeconcept of ICD-9-CM term is covered by the mappedLLT with slightly broader scope.11ICD-9-CM to MedDRA Mapping (cont) To measure how well the match is– Each pair of ICDICD-9-CM9 CM term and MedDRA LLTis categorized Caution (partial match): In most cases, the ICD-9-CMterm contains multiple concepts and the mapped LLTrepresents one of the concepts Out of (MedDRA) scope126
16/04/2013Outcome ICD-9-CM Disease and Injury Codes (codes001 to 999))– 17 Chapters based on disease, disorder, and injury Chapter 1: Infectious and parasitic diseasesChapter 9: Diseases of the digestive systemChapter 14: Congenital anomaliesChapter 17: Injury and Poisoning Similar to MedDRA anatomical,anatomical physiologicalphysiological,and etiological based System Organ Classes(SOCs)13Outcome (cont) ICD-9-CM Disease and Injury CodesDisease andInjury tionOut of scope%12503 87%3‐digit Diseaseand Injury%90598%9967%111%8836%111%00%00%147
16/04/2013Outcome (cont) ICD-9-CM E and V Codes: SupplementaryClassification for– Factors Influencing Health Status and Contactwith Health Services (codes V01-V89) “Assault by shotgun”– External Causes of Injury and Poisoning (codesE800-E999) “Family disruption” Mainly equivalent to MedDRA SOC Socialcircumstances15Outcome (cont) ICD-9-CM E and V CodesE code%V code%CompleteconfidenceRelativeconfidence1%181 15%335 26%10 1%Caution904 71%975 79%Out of scope18141%74 6%168
16/04/2013Summary Mapping direction: ICD-9-CM -- MedDRA Disease and Injury Codes– Two terminologies correlate well All levels : 94% complete or relative confidence Three-digit level: 99% complete or relative confidence– Level for data aggregation and analysis E Codes and V Codes–NNott allll iin ththe scope off MedDRAM dDRA– Different granularities – majority in “Caution”category17ICD-10 to MedDRA Mapping189
16/04/2013ICD-10 to MedDRA Mapping Use case identification– From ICDICD-1010 to MedDRA Drug safety analysis using EMR data Epidemiology study– From MedDRA to ICD-10 Healthcare cost analysis using clinical trial data Epidemiology study19ICD-10 to MedDRA Mapping (cont) Mapping feasibility study– ICD-10 core– Country modification US modification: ICD-10-CMGerman modification: ICD-10-GMAustralia modification: ICD-10-AMCanadian modificationThailand modification– ICD-10ICD 10 core level 3-character 4-character– Invite feedback of interested parties2010
16/04/2013Thank you!Questions?2111
– Microsoft Access queries and manual mappingMicrosoft Access queries and manual mapping At MedDRA Lowest Level Term ( 67,000) level All ICD-9-CM terms (3, 4, 5-digit) – Review and verify by qualified personnel (medical and MedDRA knowledge) ICH MedDRA Term Selection: Points
