A pilot program for the Food and Drug Administration’s Sentinel active surveillance system, dubbed Mini-Sentinel, is leveraging electronic healthcare data--principally claims data but also including data from EHRs--to monitor the safety of FDA-regulated medical products.

According to Janet Woodcock, M.D., 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.

“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 questionswrites Woodcock in a June 23 blog.

Eighteen large healthcare organizations across the United States, including Aetna, Humana and Kaiser Permanente, are serving as data partners for Mini-Sentinel. 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,” says Woodcock.

“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.”

Participating Mini-Sentinel organizations provide access to data as well as scientific and organizational expertise. However, the FDA provides all funding for Mini-Sentinel, determines all priorities, and retains ultimate decision-making authority.

The FDA recently completed its first study using the Sentinel system, which 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 revealed 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a rare bowel problem (intussusception) that previously caused a prior rotavirus vaccine (Rotashield ) to be voluntarily withdrawn from the market by its manufacturer.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.

 

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