Spontaneous ADR reporting in the spotlight

Abstract

Signal generation and identification of rare adverse drug reactions (ADRs) are among the strengths of spontaneous reporting as a mechanism for monitoring drug safety, according to Dr Kenneth Hartigan-Go, from the University of the Philippines, and project leader of the Philippines Adverse Drug Reactions Monitoring Programme. However, under-reporting, various types of bias in reporting and problems with data quality are important limitations. The strengths and weaknesses of spontaneous reporting were discussed during a session on spontaneous reporting at the WHO’s 50th Anniversary Symposium on ‘The Current State of Pharmacovigilance — A Critical Examination’ [ Stockholm, Sweden; December 1998 ].