Detecting Adverse Drug Reactions in Postmarketing Surveillance: Interview Validity

As part of a large-scale study developing new methods of postmarketing surveillance, computer-assisted interview information was collected from 231 outpatients receiving a target drug chosen from two pharmacological classes (antibiotics and tricyclic antidepressants) for which adverse drug reactions (ADRs) are well-documented. The standardized telephone interview used to describe and quantify all adverse clinical events (ACEs) has some questions that focus only on spontaneously reported ACEs and other detailed questions covering various specific organ systems. Analyses show that spontaneously reported ACEs generally provide the most reliable source of true ADRs. The results have important implications bearing upon the ease with which a set of ACEs may be inappropriately interpreted as possible adverse drug reactions.