who-art.pptx

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1. The WHO Adverse Reaction Terminology Features: Four-level hierarchical structure Open-ended - new terms added as necessary WHO-ART is updated with MedDRA terms appearing on WHO adverse reaction reports Computer suitable record number system Adverse reactions in English, French, German, Spanish, Portuguese and Italian Used by drug regulatory agencies and pharmaceutical manufacturers in many countries

2. Structure: 32 System-organ classes body organ groups 180 High level terms for grouping preferred terms 2000 Preferred terms principal terms for describing adverse reactions 3032 Included terms synonyms to preferred terms

3. WHO Adverse Reaction Terminology This terminology has been developed over more than 30 years to serve as a basis for rational coding of adverse reaction terms. Because new drugs and new indications produce new terms to be incorporated During 2005, a total of 69 Preferred terms and 261 Included terms were added to the terminology.

4. Development Whilst the overall robustness of the terminology is demonstrated by almost 30 years of service , there is still room for improvement. The terminology is the definition by international experts of preferred terms System Organ class 2000 - Secondary terms - events, as well as a section 2100 - Poison specific terms Also a section for effects on clinical test results by drugs (false positives or negatives) has been requested

5. Definition and use Preferred terms: These are the principal terms used for describing drug adverse reactions . They are the main terms used at the input side, but may also be used for output purposes . High level terms : These are group terms of related or similar conditions, which are used for easy retrieval of information. E.g. thrombophlebitis leg and thrombophlebitis arm represent two different preferred terms but are both grouped under thrombophlebitis as a high level term .

6. System-organ classes: These are groups of adverse reaction preferred terms pertaining to the same system-organ A preferred term can be allocated to a maximum of three different system-organ classes , e.g. respiratory depression is coded both under Respiratory disorders and Central nervous system disorders .

7. Record number system : Each preferred term is designated a record number, in consecutive order Preferred terms are always assigned the sequence number 001

8. Example showing the structure of the Adverse Reaction Terminology and the relationship between the different types of terms ARECNO INCLUDED TERMS ARECNO PREFERRED TERMS HL LINK HIGH LEVEL TERMS 0363 005 Acidos metabolic 0363 001 Acidosis 0363 Acidosis 0363 004 Bicarbonate reserve decrease         0364 003 Lactate blood increase 0364 001 Acidosis lactic 0363   0393 003 Ketoacidosis 0393 001 Ketosis 0363   0393 004 Acetonuria         0393 005 Aceton breath         0393 006 Acetonaemia        

9. System-organ classes and codes (Example) 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

10. WHO Drug Dictionary This document is a guide to the general features of the WHO Drug Dictionary You will get information about the structure and content of the dictionary as well as information about some services provided by the Uppsala Monitoring Centre (UMC) – the WHO Drug Dictionary maintenance organization.

11. Some basic facts about the WHO Drug Dictionary - Essential information on drugs from all major markets - Easy reference to both single- and multiple-ingredient drugs - A Medicinal Products dictionary compatible with other major software - Record numbers for linking and grouping information - Anatomical Therapeutic Chemical classification (ATC) used throughout

12. On December 31, 2002, the WHO Drug Dictionary contained: 45 457 proprietary drug names , of which 29 078 single-ingredient drugs 16 379 multiple-ingredient drugs 9 395 chemical substances.

13. WHO Drug Dictionary Uniqueness: It is an international classification of drugs providing proprietary drug names used in different countries, together with all active ingredients and the chemical substances with unique reference numbers . Drugs are classified according to the Anatomical-Therapeutic-Chemical classification (ATC) which allows for grouping of drugs in different ways for comparison purposes

14. The WHO International Drug Monitoring Program from 1968 onwards The WHO Drug Dictionary is currently being enhanced to accommodate commonly used herbal and traditional medicines.

15. Sources of substances and drug names Sources of non-proprietary names are: the INN (International Non-proprietary Names, WHO) publications of nationally approved agencies (e.g. USAN ) and well-known reference books , such as the Martindale - The Complete Drug Reference and the Merck Index

16. Record number system Drug Code and Medicinal Product ID Medicinal Product ID is the unique identification number in the C Format Medicinal Product ID identifies a unique combination of the following data fields: Medicinal Product Name Name Specifier - Market Authorisation Holder Country Strength (amount and unit of active ingredient/s) Dosage form (Available as Pharmaceutical Form in the Pharmaceutical Product table)