The FDA Amendments Act of 2007 (FDAAA) tasked the FDA with developing a system for monitoring the safety of FDA-regulated medical products after they reach the market. The law states this system, which would use electronic health data, should cover at least 100 million people by 2012.
FDA responded with a national strategy for monitoring medical product safety, known as the Sentinel Initiative. The goal of the Initiative is to create a national, integrated, electronic system (the Sentinel System) for monitoring medical product safety. FDA has said the system will be capable of querying existing distributed data sources — which would continue to be owned and maintained by their owners — quickly and securely for relevant de-identified product safety information. Sentinel is anticipated to leverage the capabilities of multiple existing databases of electronic health records and administrative claims.
For Sentinel to achieve its objective, it will be necessary to identify or develop specific processes and scientific methodologies to query and draw appropriate inferences from available data sources. These methods should facilitate the detection of higher-than-expected rates of adverse events in the general population (signals), as well as confirmatory analyses.
The Engelberg Center for Health Care Reform at Brookings, in cooperation with the Centers for Education and Research on Therapeutics (CERTs), convened a Think Tank to develop recommendations on the methods, tools, and scientific operations of the Sentinel System. The meeting content focused on anticipatable adverse events using routinely-collected, electronic, administrative claims and medical record data.
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