Accuracy of hepatic adverse drug reaction reporting in one English health region

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Abstract
Altogether 188 hepatic adverse drug reactions were reported during 1992-6; 138 case records were available for review during 1997-8, with the consent of those reporting the reactions (101 reports from hospital doctors, 37 from general practitioners). Adverse drug reactions were evaluated on the basis of international consensus criteria. 3 4 Reactions were classified as drug related when there was a clear temporal relation with drug intake and likely alternative causes had been excluded. They were classified as unrelated if either the onset or the course of the reaction did not suggest drug injury3 in the presence of a confirmed alternative cause for the reaction Reactions were classified as of indeterminate cause when there was temporal relation between drug intake and the reaction but also a likely alternative cause or no temporal relation but also no alternative cause for the reaction.