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FDA Pilot Program to Use EHR Data for Drug Safety Monitoring

June 26, 2014
by Rajiv Leventhal
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The U.S. Food and Drug Administration (FDA) is using electronic health record (EHR) data to monitor the safety of FDA-regulated medical products, Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, wrote in a blog post dated June 23.

FDA’s pilot program for the agency’s Sentinel System, dubbed Mini-Sentinel, uses claims and EHR data from 18 large healthcare organizations, serving as data partners, to provide answers to FDA questions about drug safety. Mini-Sentinel is part of the FDA’s Sentinel Initiative, which is exploring a variety of approaches for improving the agency’s ability to quickly identify and assess safety issues.

“When FDA safety scientists have a safety question they can submit ‘queries’ to the Mini-Sentinel data partners about the drugs being used by the patients cared for by their organization. Each partner organization maintains its own secure and privacy-protected data, in some but not all cases including EHR as well as claims data, but with the use of a common data model, the necessary information from all of the different systems can be analyzed in the same way,” Woodcock explains in her blog.

This capability enables Mini-Sentinel to provide answers to FDA questions about drug safety, she says. The Mini-Sentinel system can survey more than 350 million person years of observation, 4 billion pharmaceutical dispensings, and 4.1 billion patient encounters. “Thanks to the ability to access data from various sources, the Mini-Sentinel system can use the information from potentially more than 150 million covered lives in our nation’s healthcare system to help answer important drug safety questions,” Woodcock writes.

Woodcock admits that a key challenge for the research community is to effectively harness the data contained in EHRs. “There are many kinds of EHRs and many ways to collect and store electronic data. To readily understand and combine information from different sources, we need to further standardize the data and the way it is exchanged. This work will allow computer systems to better ‘talk’ to each other and, ultimately will lead to better treatment decisions as clinicians will have a more complete picture of their patients’ medical histories, including visits with other providers.



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