Asian Journal Of Social Pharmacy

Abstract: Objective To study the useful experience of the FDA’s Sentinel initiative and provide a reference for the smooth implementation of China’s active drug safety surveillance after marketing. Methods By searching the official website of the FDA and relevant literature at home and abroad, the development history, framework, organizational system, data source and protection, monitoring tools and application of the FDA Sentinel initiative were sorted out. Results and Conclusion Sentinel initiative is an active surveillance method adopted by the US FDA to evaluate approved drugs and other medical products by using electronic health care data from various sources, which has formed a relatively mature management system in terms of data protection monitoring tools and other aspects. Drawing on the experience of FDA, China should integrate and utilize the existing health care database and expand the source of sentinel alliance database. Besides, the government should explore distributed database management mode to protect patients privacy effectively. Meanwhile, a public-private partnership platform can be established by formulating relevant regulations and policies to encourage academic institutions and pharmaceutical companies to make full use of sentinel data for mining data security signals and developing new monitoring tools.

Key words: FDA, Sentinel initiative, active surveillance