FDA is exploring how to use information technology to create an integrated electronic postmarket safety network. The proposed Sentinel Network would combine postmarket study efforts of both public and private sectors. The goal is to deliver comprehensive product safety information directly to clinicians.
According to FDA, current postmarket safety actions are hindered by “limitations in the quality, quantity, and timeliness” of available data. The ability to quickly conduct postmarket studies is also limited. The proposed network will use electronic databases and surveillance systems to provide a “seamless, timely flow” of product information while also protecting patient privacy. Data collection, risk identification and analysis, and risk communication would be the main actions of the network.
FDA is holding a two-day public meeting in March to discuss the network. It wants to hear examples from industry groups that have access to “electronic, population-based data sets” that could be used for monitoring postmarket safety. The meeting will also discuss
The meeting will seek to identify and fill the current gaps in postmarket product safety data collection and risk processes. Future opportunities, such as collaborations between the public and private sectors to build data collection and risk components for the network, will also be explored.