WHOART Magnus Wallberg November 24 th 2009 Dar
WHO-ART Magnus Wallberg November 24 th 2009 Dar Es Salaam, Tanzania magnus. wallberg@who-umc. org
WHO-ART (WHO-Adverse Reaction Terminology) Magnus Wallberg, UMC
The need for a medical terminology dyspnoea ? fever mood swings breath shortness heart disorder Magnus Wallberg, UMC ARDS feeling high ? SOB tinnitus somnolence unconsciousness headache rash
General requirements Data entry: Data retrieval: Other: • • • comprehensive specific consistent user friendly Magnus Wallberg, UMC flexible accurate consistent user friendly multilingual definitions computer adaptation continous updating
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 Magnus Wallberg, UMC
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 Vigi. Search (and Vigi. Flow) Magnus Wallberg, UMC
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) *May 2008 Magnus Wallberg, UMC terms similar to preferred terms (3607*)
WHO-ART hierarchy - an example SOC Musculo-skeletal system disorders HLT Arthropathy PT Arthritis IT Joint inflammation Magnus Wallberg, UMC IT Osteoarthritis PT Arthropathy IT Polyarthropathy IT Joint dysfunction
WHO-ART hierarchy - example II Magnus Wallberg, UMC
Complete list of System Organ Classes * RES - Reticuloendothelial system Magnus Wallberg, UMC Skin and appendages disorders Musculo-skeletal system disorders Collagen disorders Central & peripheral nervous system disorders Autonomic nervous system disorders Vision disorders Hearing and vestibular disorders Special senses other, disorders Psychiatric disorders Gastro-intestinal system disorders Liver and biliary system disorders Metabolic and nutritional disorders Endocrine disorders Cardiovascular disorders, general Myo-, endo-, pericardial & valve disorders Heart rate and rhythm disorders Vascular (extracardiac) disorders Respiratory system disorders Red blood cell disorders White cell and RES* disorders Platelet, bleeding & clotting disorders Urinary system disorders Reproductive disorders, male Reproductive disorders, female Foetal disorders Neonatal and infancy disorders Neoplasms Body as a whole - general disorders Application site disorders Resistance mechanism disorders 0100 0200 0300 0410 0420 0431 0432 0433 0500 0600 0700 0800 0900 1010 1020 1030 1040 1100 1210 1220 1230 1300 1410 1420 1500 1600 1700 1810 1820 1830 Secondary terms - events Poison specific terms 2000 2100
WHO-ART System Organ Classes Skin and appendages disorders 0100 Musculo-skeletal system disorders 0200 Collagen disorders 0300 etc. . . Secondary terms etc. . . 2000 events not likely to be a direct effect of a drug, e. g. medication error, wound infection, burn, fall Poison terms e. g. foetal alcohol syndrome, silicosis, chemical burn Magnus Wallberg, UMC 2100
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 Magnus Wallberg, UMC
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 Magnus Wallberg, UMC
But. . . what about Med. DRA Magnus Wallberg, UMC
Features of Med. DRA in comparison to WHO-ART • More terms in Med. DRA – More fine granular – Easier to give correct description of a reaction • More levels in Med. DRA – Other interesting levels for statistical analysis • SMQs (Standardized Med. DRA Queries) – To simplify analysis when using Med. DRA • ICH Med. DRA Points-to-Consider Documents – Developed to facilitate consistent input and output
Structure comparison
Content and mapping comparison
Med. DRA/WHO-ART grouping • Given the differences, how can Med. DRA and WHOART be used in parallel – Reports are always coded on PT/LLT level, same as for WHO-ART where PT/IT is used – Multiple Med. DRA terms can correspond to the same WHOART term (and in rare cases vice versa) – Some Med. DRA 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” !
Med. DRA grouping structure WHO-ART view 2 reports 1 term Med. DRA view 2 reports 2 terms
WHO Collaborating Centre for International Drug Monitoring Box 1051, SE - 751 40 Uppsala Sweden Tel +46 18 65 60 60, Fax +46 18 65 60 88 E-mail: info@who-umc. org Website: www. who-umc. org
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