Coming Soon: A Digital Watchdog for Drugs
Seems like you can’t open the newspaper these days without seeing yet another story questioning the safety of a prescription drug. But there’s currently no central system that allows the U.S. Food and Drug Administration (FDA) to request information from existing organizations and databases—information that when analyzed as a whole could reveal potential problems with new products. That’s why the FDA has announced the formation of a new program called the Sentinel Initiative to monitor the safety of drugs and other medical products.
“Right now we rely on people reporting possible adverse events,” says Melissa Robb of the FDA’s Office of Critical Path Programs. “First they have to notice an event related to a drug, and then they have to report that to the FDA.” The new system, she says, will be “a tool to send out queries to look for possible associations for data that’s already out there—claims data, electronic health records, and more.” In addition to these records, a new federal regulation will make it possible for Sentinel to draw prescription data from the Centers for Medicare and Medicaid Services. The program will involve the collaboration of both private entities, like the E-Health Foundation, and federal partners, including the Department of Defense, the Centers for Disease Control and Prevention, and the U.S. Department of Veteran’s Affairs. That information will then be analyzed and distributed, depending on the particular situation.
It will be at least a couple of years before the system is in place. The current reporting system, MedWatch, will remain active at that point. “We’d love ultimately for these two systems to be working together,” says Nancy Derr, also of the Office of Critical Path Programs. “Say we get a report in MedWatch, and that could trigger research when we have Sentinel enforced. This could trigger a proactive investigation.” When it comes to drug safety, in other words, the more eyes, the better.





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