Postmarketing Drug Safety Surveillance

Postmarketing drug safety surveillance has undergone many changes, especially over the past decade when international harmonization on safety reporting and risk management strategies were adopted by regulators worldwide. It is important for readers in the field to keep abreast of the most recent occurrences and future trends. This review provides an overview of the latest regulatory initiatives in postmarketing drug safety surveillance and outlines major trends observed in three major economic regions (the European Union, Japan, and the US). The report encompasses regulatory developments in safety reporting, safety signal analyses, and risk management strategies. In addition, an overview of other important areas, such as medication errors, pharmacogenomics, and the future of pharmacovigilance, is also included. Overall, the most important initiative is the application of the concept of risk management programs. Regulatory authorities are currently developing guidance to the industry and healthcare providers through various concept papers and workshops. In addition, global harmonization of safety reporting has taken place within regulatory agencies for some time. These initiatives could strengthen the ability of pharmacovigilance organizations to review and monitor the safety of drug products. Furthermore, automated data-mining techniques have been developed and used to systematically screen adverse drug events for early safety signal detection. The future conduct of postmarketing drug safety surveillance is likely to be evidence-based, technology-driven, and patient-focused.