The New Sentinel Network — Improving the Evidence of Medical-Product Safety

In 2007, Congress directed the Food and Drug Administration (FDA) to create a new postmarketing surveillance system that will, by 2012, be using electronic health data from 100 million people to prospectively monitor the safety of marketed medical products. This new system is intended to complement existing systems of “spontaneous” adverse-event reporting. In May 2008, the FDA announced the Sentinel Initiative, which would “access the capabilities of multiple, existing data systems (i.e., electronic health record systems, medical claims databases). The network of data systems is intended both to detect signals (i.e., higher-than-expected rates of adverse outcomes) and to confirm signals, including those suggested by other sources, and to do so rapidly and quantitatively. At a recent Senate hearing before her confirmation, FDA Commissioner Margaret Hamburg stated that close postmarketing monitoring of medical-product safety would remain a high priority during her tenure.

Achieving these goals requires the first large-scale, truly integrated use of the electronic data that are increasingly available in our pluralistic health care system. The first hurdles are determining how best to organize the Sentinel Network, how it should operate, and what steps are needed for its implementation.
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