FDA Pilot Program Leverages EHR Data For Monitoring Drug Safety
By Christine Kern, contributing writer
Using EHR and claims data, Mini-Sentinel can provide answers about drug safety.
The FDA’s pilot program for the agency’s Sentinel System, dubbed Mini-Sentinel, is leveraging electronic healthcare data – principally claims data but also data from EHRs – to monitor the safety of FDA-regulated medical products. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, explained that the Mini-Sentinel system can survey more than 350 million person years of observation, 4 billion pharmaceutical dispensings, and 4.1 billion patient encounters.
There are 18 large healthcare organizations across the country, including Aetna, Humana, and Kaiser Permanente, which serve as data partners for Mini-Sentinel. FDA safety scientists who have safety questions 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 individual secure and privacy-protected data, which might contain claims data, EHR data, or both. With the use of a common data model, the necessary information from all of the different systems can be analyzed in the same way. This capability enables Mini-Sentinel to provide answers to FDA questions about drug safety.
Woodcock wrote in an FDA blog, “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 health care system to help answer important drug safety questions.
“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,” she adds. “This capability enables Mini-Sentinel to provide answers to FDA questions about drug safety.”
The FDA provides all funding for Mini-Sentinel, determines all priorities, and retains ultimate decision-making authority, while participating Mini-Sentinel organizations provide access to data as well as scientific and organizational expertise.
The FDA‘s first study using the Sentinel system evaluated the safety of the two current vaccines (RotaTeq and Rotarix) that prevent rotavirus infection (the leading cause of severe diarrhea and dehydration in infants). The study was able to leverage available data to reveal that these rotavirus vaccines slightly raise the risk of a rare bowel problem (intussusception) that previously caused a prior rotavirus vaccine (Rotashield) to be voluntarily withdrawn from the market by its manufacturer.
The study also showed that the newer vaccines have a much lower rate of this bowel problem and are safer, with the benefits outweighing the risks, including the risk of intussusception, associated with vaccination.
"Within Sentinel, FDA has supported the development of software that analyzes information from health insurance and health record databases to search for evidence that certain products are linked to specific adverse effects," wrote Michael Nguyen, M.D., Acting Director of the Division of Epidemiology in FDA’s Center for Biologics Evaluation and Research in an FDA blog. "Although these data are protected behind tight firewalls and remain under the control of the original health insurance plans that created them, the software makes it possible to analyze the information without disclosing identifying information in order to strictly maintain patient privacy."