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eHealth Initiative's Drug Safety Collaboration to Partner With FDA on Sentinel Initiative
Date:5/22/2008

eHI's multi-stakeholder "Connecting Communities for Drug Safety Collaboration" conducting drug safety pilots to test and evaluate use of electronic health information to support post-market monitoring efforts

WASHINGTON, May 22 /PRNewswire-USNewswire/ -- The non-profit eHealth Initiative (eHI) announced today its support of and collaboration with the Food and Drug Administration (FDA) on the Sentinel Initiative, a far-reaching public and private sector program aimed at improving the nation's ability to more quickly and effectively monitor post-market drug performance.

eHI's Connecting Communities for Drug Safety Collaboration (the Collaboration), which will help inform the Sentinel Initiative, is a public-private sector effort conducted in partnership with the FDA. The purpose of the project is to test and evaluate the feasibility and value of using electronic health information--through a distributed model -- to support post-market surveillance and drug safety.

"We are delighted to be partnering with eHI on this important project," said Janet Woodcock, MD, Director, Director, Center for Drug Evaluation and Research, Food and Drug Administration. "The results of the pilots will help us evaluate methods and technical approaches for using electronic data to support post-market surveillance and assess the legal and institutional policy issues involved."

The Collaboration just completed in April 2008 its first iteration of testing and evaluation of using a combination of clinical data from electronic health records and other clinical systems and administrative claims data to detect and evaluate drug safety signals for a set of three "use cases." The use cases tested and evaluated included possible liver side effects related to the use of cholesterol-lowering drugs, bleeding episodes related to warfarin, and a small set of adverse patient events commonly associated with medications, or "designated medical events" or DMEs. This research
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