FDA pilot program surveys EHR, claims data to monitor drug safety

FDA’s pilot program for the agency’s Sentinel System—dubbed Mini-Sentinel—is utilizing EHR data in combination with claims information to better monitor the safety of FDA-regulated products.

Currently 18 large healthcare organizations serve as data partners for Mini-Sentinel. FDA safety scientists submit queries about medications in use by parents treated at these organizations, according to a blog post written by Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

The Mini-Sentinel system can survey more than 350 million person years of observation, 4 billion pharmaceutical dispensings and 4.1 billion patient encounters, according to Woodcock. “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,” she wrote.

The agency is teaming up with standards-setting organizations to develop solutions to help researchers, medical product developers and healthcare professionals increase collective knowledge and tools in medicine, she wrote. “We collaborate with, and support others in our healthcare system and in the research community who are working on efforts to harness the power of electronic healthcare data.”

Read the blog post here.