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

The lack of specific markers for drug induced liver injury suggests that inaccurate reports of hepatic adverse drug reactions are likely to be common, with the diagnosis based on circumstantial evidence and speculation by the reporting clinician. The problems of assessing the cause of drug induced liver injury have led to consensus meetings to establish a standardised framework for evaluating drug hepatotoxicity. 3 Using these international criteria, we aimed at evaluating the accuracy of reports of hepatic adverse drug reactions to the Committee on Safety of Medicines in the Northern region in 1992-6. When the cause of liver injury had been incorrectly attributed to a drug we also determined the frequency of missed or delayed diagnoses.