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Classification of ADRs: a proposal for harmonization and differentiation based on the experience of the Comprehensive Hospital Drug Monitoring Bern/St. Gallen, 1974–1993
Author(s) -
Hunziker Thomas,
Bruppacher Rudolf,
Kuenzi Urs Peter,
Maibach Ruedi,
Braunschweig Suzanne,
Halter Fred,
Hoigné Rolf V.
Publication year - 2002
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.669
Subject(s) - medicine , drug reaction , idiosyncrasy , drug , pharmacoepidemiology , drug allergy , harmonization , adverse drug reaction , pharmacovigilance , pediatrics , university hospital , intensive care medicine , pharmacology , physics , finance , medical prescription , acoustics , economics
The present paper deals with the classification of adverse drug reactions (ADRs) according to today's largely accepted pathomechanisms. The classification system applied, relies primarily on the proposals of Rawlins and Thomson with type A (‘augmented’) and B (‘bizarre’) reactions. In the database of the Comprehensive Hospital Drug Monitoring (CHDM) Bern/St. Gallen on 48 005 consecutively hospitalized patients, ADRs had been attributed to 10 different pathomechanisms. These permit a versatile new system, easily adaptable to expanding knowledge. lf we look at the 12 785 ADRs registered in the CHDM Bern/St. Gallen from 1974 to 1993, 76% were of type A, 13% of type B, and 11% of a pathomechanism not yet defined (type X). The main subgroups were A 1 ‘not specified’ in type A, B a allergic/immunological and B pa pseudoallergic/anaphylactoid in type B. Dose‐related (A 2 ) and drug‐related reactions (A 4 , intolerance in a restricted sense), drug‐to‐drug interactions (A 5 ), rebound/withdrawal effects (A 6 ) and secondary reactions (A 7 ) represented smaller subgroups. Patient‐related reactions (A 3 , ‘idiosyncrasy’ in the strict sense) were not assessed. Today's algorithms for ADRs mainly rely on pharmacological, i.e. type A reactions. For most of the type B reactions adaptations including the experience of allergists, clinical immunologists and infectious disease specialists should be respected. Copyright © 2002 John Wiley & Sons, Ltd.