WHO-ART. Magnus Wallberg. November 24 th 2009 Dar Es Salaam, Tanzania.
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1 WHO-ART Magnus Wallberg November 24 th 2009 Dar Es Salaam, Tanzania
2 WHO-ART (WHO-Adverse Reaction Terminology)
3 The need for a medical terminology dyspnoea? tinnitus ARDS fever feeling high mood swings breath shortness? unconsciousness heart disorder headache SOB somnolence rash
4 General requirements Data entry: Data retrieval: Other: comprehensive specific consistent user friendly flexible accurate consistent user friendly multilingual definitions computer adaptation continous updating
5 WHO-ART Developed for the WHO Drug Monitoring Programme in use for 40 years for adverse reaction monitoring NOT for indications, tests, background diseases etc. used by both regulatory agencies and pharmaceutical manufacturers maintained by the UMC
6 WHO-ART cont. 4 level hierarchial structure New terms added when necessary Created in English Translations in French, German, Italian, Spanish, Portuguese (Chinese, Japanese, Korean, Russia) Paper print, CD and electronical version Latest version available in VigiSearch (and VigiFlow)
7 WHO-ART hierarchy System Organ Class (SOC) group of preferred terms pertaining to the same body organ (32*) High level term (HLT) group of similar preferred terms (184*) Preferred Term (PT) principal terms for coding and presentation (2158*) Included Term (IT) terms similar to preferred terms (3607*) *May 2008
8 WHO-ART hierarchy - an example SOC Musculo-skeletal system disorders HLT Arthropathy PT Arthritis PT Arthropathy IT Joint inflammation IT Osteoarthritis IT Polyarthropathy IT Joint dysfunction
9 WHO-ART hierarchy - example II
10 Complete list of System Organ Classes * RES - Reticuloendothelial system Skin and appendages disorders 0100 Musculo-skeletal system disorders 0200 Collagen disorders 0300 Central & peripheral nervous system disorders 0410 Autonomic nervous system disorders 0420 Vision disorders 0431 Hearing and vestibular disorders 0432 Special senses other, disorders 0433 Psychiatric disorders 0500 Gastro-intestinal system disorders 0600 Liver and biliary system disorders 0700 Metabolic and nutritional disorders 0800 Endocrine disorders 0900 Cardiovascular disorders, general 1010 Myo-, endo-, pericardial & valve disorders 1020 Heart rate and rhythm disorders 1030 Vascular (extracardiac) disorders 1040 Respiratory system disorders 1100 Red blood cell disorders 1210 White cell and RES* disorders 1220 Platelet, bleeding & clotting disorders 1230 Urinary system disorders 1300 Reproductive disorders, male 1410 Reproductive disorders, female 1420 Foetal disorders 1500 Neonatal and infancy disorders 1600 Neoplasms 1700 Body as a whole - general disorders 1810 Application site disorders 1820 Resistance mechanism disorders 1830 Secondary terms - events 2000 Poison specific terms 2100
11 WHO-ART System Organ Classes Skin and appendages disorders Musculo-skeletal system disorders Collagen disorders etc etc... Secondary terms events not likely to be a direct effect of a drug, e.g. medication error, wound infection, burn, fall 2000 Poison terms e.g. foetal alcohol syndrome, silicosis, chemical burn 2100
12 WHO-ART - Critical terms Definition; A subset of adverse reaction terms referring to, or possibly being indicative of, serious disease states, which have been regarded as particularly important to monitor e.g. Death, anaphylactic shock, convulsions, erythema multiforme
13 WHO-ART summary WHO-ART makes it easy to sort and search information on ADRs 4 level hierarchial structure Preferred terms are the principle terms for coding and output Multilingual Critical terms list for focus on more serious outcomes
14 But... what about MedDRA
15 Features of MedDRA in comparison to WHO-ART More terms in MedDRA More fine granular Easier to give correct description of a reaction More levels in MedDRA Other interesting levels for statistical analysis SMQs (Standardized MedDRA Queries) To simplify analysis when using MedDRA ICH MedDRA Points-to-Consider Documents Developed to facilitate consistent input and output
16 Structure comparison
17 Content and mapping comparison MedDRA WHO-ART
18 MedDRA/WHO-ART grouping Given the differences, how can MedDRA and WHO- ART be used in parallel Reports are always coded on PT/LLT level, same as for WHO-ART where PT/IT is used Multiple MedDRA terms can correspond to the same WHO- ART term (and in rare cases vice versa) Some MedDRA terms representing indications, non ADR events and laboratory tests must be mapped to a generic WHO-ART term The above considerations result in what we call a Grouping Structure!
19 MedDRA grouping structure Report1 Report2 WA1 M1 WHO-ART view 2 reports 1 term WA2 WA3 M2 M3 M4 M5 M6 MedDRA view 2 reports 2 terms WA4 M7 WA5 M8
20 WHO Collaborating Centre for International Drug Monitoring Box 1051, SE Uppsala Sweden Tel , Fax info@who-umc.org Website:
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