The evolution of pharmacovigilance: the contributions of Michael D Rawlins

Abstract

Summary In the last 175 years, pharmacovigilance has evolved, albeit sometimes in response to serious incidents. The late Professor Sir Michael D Rawlins made major contributions to pharmacovigilance internationally. He proposed a widely used classification of adverse drug reactions (ADRs). He highlighted the importance of post-marketing surveillance immediately after a medicine's launch, and the strengths and weaknesses of existing spontaneous suspected ADR reporting systems. He encouraged the broadening of pharmacovigilance to involve all health professional groups, as well as patients. He highlighted the value of all sources of evidence and of judgement in making risk-benefit assessments. He was a strong early advocate of greater use of databases and registries, and of continuing surveillance throughout the lifespan of medicines as therapeutic agents.