Reasons for reporting adverse drug reactions--some thoughts based on an international review

Abstract

A pilot study was made to explore positive reasons for physicians and pharmacists taking time to report adverse reactions, rather than reasons for failing to report which has been studied by many authors. The 34 national drug monitoring centres participating in the international programme at the time of the study were asked by letter from the WHO Collaborating Centre for International Drug Monitoring, Uppsala to investigate the reasons why adverse reactions were reported. National Centres were asked to write to 20 consecutive reporters, sending each a copy of their own report, asking why they had chosen to report that particular reaction, and asking for more general comment. Twelve countries responded with information about the habits and views of the reporters of 177 cases. Since this was an explorative pilot study the letter to reporters deliberately had only an open question about reason for reporting. Categories were developed by the WHO Centre from the responses given. Reasons for reporting fell into a total of 14 categories with the great majority in the top six: motivation to contribute to medical knowledge, reaction previously unknown to reporter, reaction to new drug, all significant reactions reported, known association between drug and reaction, and severity of reaction.