BMJ  2003;327:1222-1225 (22 November), doi:10.1136/bmj.327.7425.1222

Education and debate

Joining the DoTS: new approach to classifying adverse drug reactions

¹ University Department of Clinical Pharmacology, Radcliffe Infirmary, Oxford OX2 6HE, ² West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital, Birmingham B18 7QH, UK

A new classification system for adverse drug reactions based on time course and susceptibility as well as dose responsiveness should improve drug development and management of adverse reactions

The first 150 words of the full text of this article appear below.

The pharmacological classification of adverse drug reactions whose causality has been established currently rests on the perceived dose dependence and predictability of the adverse reaction. It is based on a proposal of Rawlins and Thompson, prefigured by others (see table A on bmj.com), to classify adverse drug reactions into two types¹: type A reactions, dose dependent and predictable from the known pharmacology of the drug; and type B reactions, not dose dependent and unpredictable.² This classification is simple; it helps drug regulation because prelicensing studies can reveal type A reactions,³ and it predicts that dose titration will reduce the risk of some reactions. However, it is sometimes difficult or impossible to assign a reaction to one type. For example, dose dependent (type A) nausea and vomiting due to erythromycin could also be classified as type B because it is not pharmacologically predictable.

Furthermore, other types of adverse reactions are . . . [Full text of this article]

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