tools for recording - who.int · system organ class 26. 18 drug classification • consistency...
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Terminologies for recording of ADR:s
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Adverse reaction terms
• ? Dizziness• SOB• . feeling hot• . ?• dyspnoea lightheadedness• . ?• breath shortness• . evidence of VEBS on
ECG
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Concepts
• Terminology– collection of accepted terms
• Thesaurus– relationships included
• Dictionary– with definitions
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Major thesauri for coding of ADR information
• WHO-ART – WHO Adverse Reaction Terminology
• MedDRA– Medical Dictionary for Regulatory
Activities
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WHO-ART
• Developed for the WHO Drug Monitoring Programme– since 1968– for adverse reaction monitoring– used also by pharmaceutical companies
• also for use in clinical trials
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WHO-ART hierarchyContent December 2001
Included Term2 758
Preferred Term1 930
High Level Term180
System Organ Class32Body organ
Grouping of PT
Principle terms for coding
Synonyms to PT
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WHO-ART• System Organ classes
– Skin and appendages disorders• 0100
– Musculoskeletal disorders• 0200
– etc.• ...
– Secondary terms• 2000
– Poison specific terms• 2100
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WHO-ART
Heart pounding IT Heart fluttering IT
Palpitation PT
Pulse rate increased IT Sinus tachycardia IT
Tachycardia PT
Tachycardia HLT
Heart rate & rhythm disorders SOC
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WHO-ART TranslationsThrough the Record Number System
RASHEnglish
ERUPTIONFrench
HAUTAUSSCHLAGGerman
RASH CUTANEOItalian
ERUPCION CUTANEASpanish
ERUPCAO CUTANEAPortuguese
Record Number0027
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WHO-ART - File Layout
• Record No 0364• Seq. No 001• High Level term link 0363• System Organ Class 0800• Text Acidosis lactic
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WHO-ARTAvailability
• Computer files• Diskette or FTP• Paper print• English• French• German• Italian• Portuguese• Spanish
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WHO-ART Definitions
• Preferred term• APNOEA• Definition• Cessation of airflow at the nose
and mouth for at least 10 sec.• Basic requirement• Demonstration according to the
definition
• Reference
• CIOMS; Harmonizing the use of adverse-drug-reaction terms, Geneva, 1996
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WHO-ARTCritical Terms
• Critical terms are 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.
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Use of WHO-ARTExample
SUMATRIPTAN
AUS DEN NET SWE
Cardiovascular disorders
Hypertension 5 1 3Oedema 2Pallor 4Syncope 2 3
Heart rate and rhythm disorders
Arrhythmia 3Palpitation 5 6 5 3Tachycardia 5
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ICD-ART
• WHOART will be put in XML format• ICD-WHOART bridge will be created• Possible to find corresponding and
related terms in the three terminologies• Possible to pool datasets• Possible to perform advanced querying
in literature• Possible to add other terminologies
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MedDRAMedical Dictionary for Regulatory
Activities• For all areas
relevant to drug regulation– clinical studies (pre-
and post marketing)– spontaneous ADR:s– regulatory
submissions– product information
• For all medical information e.g.:– symptoms– signs– diseases– diagnoses– investigations– procedures– medical/social/family
history
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MedDRA structure
Lowest Level Term55638
Preferred Term15709
High Level Term1683
High Level Group Term332
System Organ Class26
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Drug Classification• Consistency• Structure
– to allow easy and flexible data retrieval and analysis
• Groupings– Chemical – Indication
• Hierarchical– to allow different levels of precision
• Up to date
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WHO Drug Dictionary
• Source of international drug names• Includes all drugs reported to the
WHO Drug Monitoring Programme
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WHO Drug Dictionary Contents
• information on:– Active substances– Pharmaceutical form and strength– Manufacturers and license holders – ATC classification– Reference sources– Drug record numbers
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WHO Drug Dictionary
• Proprietary drug names– single-ingredient drugs– multiple-ingredient drugs
• Generic drug names
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WHO Drug DictionaryContents
• March 2002:•44 500 proprietary drug names
•28 400 single-ingredient drugs
•16 100 multiple-ingredient drugs
• 9 200 chemical substances• 2 500 drug names added yearly
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WHO Drug Dictionary• Example illustrating the record number
systemDrug name Drecno Seq1 Seq2
Amantadine 559 01 001
Amantadine HCl 559 02 001Virofral 559 02 002Symmetrel 559 02 003
Amantadine sulfate 559 03 001PK-Merz 559 03 002Contentron 559 03 003
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WHO Drug Dictionary
Preferred name for single ingredient drug
Nonproprietary nam es Source o f reference:(Designation = N) IN N nam e
MartindaleIndex N om inumNegwerStofflisteUSA NMerck Index
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WHO Drug Dictionary ATC System
• Anatomical-Therapeutic-Chemical• Hierarchical structure• Continuously revised and updated• Guidelines for coding available• International applicability• Adopted by WHO
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ATC Classification system
A Alimentary tract and metabolismB Blood and blood forming organsC Cardiovascular systemD DermatologicalsG Genito-urinary system & sex hormonesH Systemic hormonal preparations, excl. sex hormonesJ General antiinfectives, systemicL Antineoplastics and immunosuppressantsM Musculo-skeletal systemN Central nervous systemP Anti-parasitic productsR Respiratory systemS Sensory systemV Various
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ATC Structure
01 - DiazepamChemical Substance
04 - OxazepamChemical Substance
A - BenzodiazepinesChem/Ther/Pharm Subgroup
B - TranquillizersPharmacological Subgroup
05 - PsycholepticsTherapeutic Subgroup
N - Central Nervous SystemAnatomical Main Group
N05BA 01 - Diazepam
N05BA 04 - Oxazepam
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Drug name Des Drecno Seq1 Seq2
Atropine N 28 01 001Atropinol T 28 01 002
Atropine sulfate N 28 02 001Isopto-Atropin T 28 02 002
Barbitropin M 324 01 001Atropine sulf. C Phenobarbital C
Atrobarb M 324 01 002Atrosed M 324 01 003
A03BAS01FA
A03BAS01FA
A03CB
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WHO Drug DictionaryThe use of ATC codes for searches
ACE Inhibitors vasculitis C09A
Antihistamines cardiac effects R06
Oral contraceptives venous G03Athromboembolism
NSAID's GI bleedings M01A
Cephalosporins respiratory insufficiency J01DA
Quinolones haemolytic anaemia J01M
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Herbal ATC system
05 - Linum usitatissimum L. seedsIndividual Herbal Substance
C - LaxativesChem/Ther/Pharm Subgroup
A - LaxativesPharmacological Subgroup
06- LaxativesTherapeutic Subgroup
A - Alimentary tract and metabolismAnatomical Main Group
H - Herbal Remedy
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Herbal ATC System
• Selective herbal searches
• Retrieval of summary data
• Group comparison searches
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WHO Drug Dictionary
• Drug Dictionary files– sequential copy of the relational data base– ASCII text file– available on CD– complete data base or quarterly updates
• Searchable through Web-search
Versions available
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The summer residence of Carl von Linné