FDA Surveillance System Leverages Databases to Monitor Medical Products for Adverse Events

The Food and Drug Administration is actively searching more than 100 million health insurance records to uncover possible adverse events, rather than relying on doctors and patients to report them, according to Michael Nguyen, M.D., Acting Director of the Division of Epidemiology in FDA’s Center for Biologics Evaluation and Research.

The surveillance system, called Sentinel, is the result of a partnership between FDA and the Harvard Pilgrim Healthcare Institute, who are using the system to determine whether a certain type of immune therapy is associated with heart attacks or strokes, and to better define the true rate of acute lung injury after transfusions of certain blood components. 

"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 Nguyen in a March 18 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."

He said that 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a rare bowel problem (intussusception) that previously caused a prior rotavirus vaccine (Rotashield ) to be voluntarily withdrawn from the market by its manufacturer.

However, at the same time, 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.

"The Sentinel rotavirus vaccine and immune therapy studies are examples of how FDA scientists are harnessing the power of big electronic databases to ensure the safety of the medical products we use every day," Nguyen concluded.

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