FDA Pilot Program to Use EHR Data for Drug Safety Monitoring | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

FDA Pilot Program to Use EHR Data for Drug Safety Monitoring

June 26, 2014
by Rajiv Leventhal
| Reprints

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.

Topics

News

NewYork-Presbyterian, Walgreens Partner on Telemedicine Initiative

NewYork-Presbyterian and Walgreens are collaborating to bring expanded access to NewYork-Presbyterian’s healthcare through new telemedicine services, the two organizations announced this week.

ONC Releases Patient Demographic Data Quality Framework

The Office of the National Coordinator for Health IT (ONC) developed a framework to help health systems, large practices, health information exchanges and payers to improve their patient demographic data quality.

AMIA, Pew Urge Congress to Ensure ONC has Funding to Implement Cures Provisions

The Pew Charitable Trusts and the American Medical Informatics Association (AMIA) have sent a letter to congressional appropriators urging them to ensure that ONC has adequate funding to implement certain 21st Century Cures Act provisions.

Former Michigan Governor to Serve as Chair of DRIVE Health

Former Michigan Governor John Engler will serve as chair of the DRIVE Health Initiative, a campaign aimed at accelerating the U.S. health system's transition to value-based care.

NJ Medical Group Launches Statewide HIE, OneHealth New Jersey

The Medical Society of New Jersey (MSNJ) recently launched OneHealth New Jersey, a statewide health information exchange (HIE) that is now live.

Survey: 70% of Providers Using Off-Premises Computing for Some Applications

A survey conducted by KLAS Research found that 70 percent of healthcare organizations have moved at least some applications or IT infrastructure off-premises.