Edwards and Aronson reported a definition of adverse drug reactions (ADR). The authors are from the Uppsala Montioring Centre in Sweden and Radcliffe Infirmary in England.
The classification of adverse drug reactions reported is the World Health Organization (WHO) classification.
Definition of an adverse drug reaction - all of the following:
(1) appreciable harmful or unpleasant reaction
(2) results from an intervention related to the use of a medicinal product
(3) predicts hazard from future administration
(4) warrants one or more of the following:
(4a) prevention
(4b) specific treatment
(4c) alteration in the dosage regimen
(4d) withdrawal of the product
Determination of causality is based on:
(1) timing
(2) pattern of the reaction
(3) results of investigations
(4) rechallenge
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