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Medical News & Perspectives
July 9, 2008

FDA Turns to Electronic “Sentinel” to Flag Prescription Drug Safety Problems

JAMA. 2008;300(2):156-157. doi:10.1001/jama.300.2.156

In response to criticism of its existing systems for monitoring the safety of drugs and medical devices, the US Food and Drug Administration (FDA) is launching a new electronic system for identifying safety problems once a drug is on the market.

The Sentinel Initiative was officially launched by the agency in May, though some pilot studies were already under way (Kuehn BM. JAMA. 2006;296[12]:1457). Although the program initially will probe claims from Medicare's Part D prescription drug program cross referenced with medical and hospitalization Medicare claims, the agency said it is developing public-private partnerships that will eventually allow it to search health care databases from insurers, hospitals, and other entities that collect such information.