Phase One of the FDA's Sentinel program for real-time monitoring of drug safety problems is now operational.
At a meeting in Washington and in a simultaneous online publication in the New England Journal of Medicine, program leaders drew back the curtain on Mini-Sentinel, a pilot program that accesses patient databases maintained by health plans and other organizations.
The FDA contracted with the Harvard Pilgrim Health Care Institute in Boston and the Brookings Institution's Engelberg Center for Health Care Reform to design the system, which is now capable of querying claims data on some 60 million individuals, without revealing identities of specific patients.
In the NEJM article, representatives of the three organizations reviewed the development of Mini-Sentinel and plans for its future. Authors of the paper are the agency’s Rachel Behrman (lead author), Janet Woodcock and former CMS Administrator and FDA Commissioner Mark McClellan (Engelberg Center).
"The FDA will soon begin to actively monitor the data, seeking answers to specific questions about the performance of medical products, such as the frequency of myocardial infarction among users of oral hypoglycemic agents …Using the Mini-Sentinel system, the FDA will also be able to obtain rapid responses to new questions about medical products and, eventually, to evaluate the health effects of its regulatory actions," they wrote.
Behrman and colleagues noted that the system could benefit agencies and organizations beyond the FDA, such as those concerned with quality measurement, public health surveillance, and comparative effectiveness.
"Healthcare data represent a precious resource that must be used to the fullest possible extent to promote the public health, while the rights of patients and consumers are protected.”
“Science is nothing but trained and organized common sense, differing from the latter only as a veteran may differ from a raw recruit: and the methods differ from those of common sense only as far as the guardsman’s cut and thrust differ from the manner in which a savage wields his club.”
Thomas Huxley
