Adverse drug reactions—or interactions—can increase your exposure to a malpractice lawsuit. New initiatives are underway to let doctors know about potential dangers more quickly than ever.
Working in partnership with the FDA, health-plan giant WellPoint, Inc. is designing a computer program called the Safety Sentinel System that will monitor the claims records of its 35 million members for troublesome risk patterns.
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“The discovery of important risks of drugs like Vioxx and Avandia has demonstrated that the health care system currently has no reliable means of quickly measuring the safety of drugs once they’re in widespread use,” noted Jerry Avorn, MD, a professor at Harvard Medical School and chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital in Boston. Harvard, the University of North Carolina, and the University of Pennsylvania are collaborating on the project.
The FDA currently relies on physicians and pharmaceutical companies to manually file reports on serious adverse events. The reports then must be collated and analyzed in a time-consuming process.
The Safety Sentinel System, however, is designed to operate in real time. It may also permit combinations of treatments to be scrutinized for safety risks, particularly in patients with chronic conditions.
“Our initial developmental work on the system has clearly demonstrated its ability to detect adverse events rapidly,” explains Sam Nussbaum, MD, WellPoint’s chief medical officer. “We were able to pick up a safety signal within a few months on certain drugs. In the industry’s current system it can take more than five years.”
This critical information will allow health-care decision-makers including federal agencies, physicians, consumers and manufacturers to move more quickly than in the past in ad-dressing potential drug risks.
HealthCore, a WellPoint subsidiary, is expected to start uploading patient data early next year, according to published reports. Plans for similar projects with other insurance companies are under way.
“The FDA is planning a larger public-private partnership. To rapidly and successfully identify emerging safety problems, we need to bring all health-care stakeholders to the table,” observes Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
