Improving Drug Safety

Abstract

Spontaneous reporting systems (SRS) as a form of post-market drug-safety passive surveillance were created several decades ago. SRS do have several limitations. Somewhat common but serious events will not necessarily prompt the filing of a report. Reporting is voluntary, leading to under-reporting of adverse events, and submitted reports are often lacking in detail. Post-market active drug-safety surveillance is now emerging as a realistic and powerful complement to SRS. Recent examples of active surveillance systems are presented in this paper; these have some, but not all, the elements of an ideal active surveillance programme.