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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.

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          Abstract

          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. If 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 A1 'not specified' in type A, Ba allergic/immunological and Bpa pseudoallergic/anaphylactoid in type B. Dose-related (A2) and drug-related reactions (A4, intolerance in a restricted sense), drug-to-drug interactions (A5), rebound/withdrawal effects (A6) and secondary reactions (A7) represented smaller subgroups. Patient-related reactions (A3, '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.

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          Author and article information

          Journal
          Pharmacoepidemiol Drug Saf
          Pharmacoepidemiology and drug safety
          Wiley-Blackwell
          1053-8569
          1053-8569
          Mar 2002
          : 11
          : 2
          Affiliations
          [1 ] Department of Dermatology, University of Bern, Inselspital, CH-3010 Bern, Switzerland. thomas.hunziker@insel.ch
          Article
          10.1002/pds.669
          11998541
          2c2b32ed-61e5-4d38-ae3c-9fbd25a832d5
          History

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