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Report Points to Flaws in System for Tracking Prescription Drug Side Effects

Feb 6, 2015

The Institute for Safe Medication Practices, a nonprofit that focuses on drug safety issues, reports that the main system for tracking dangerous side effects of prescription drugs is seriously flawed because drug makers are submitting incomplete information about problems to the Food and Drug Administration (FDA).

According to the report, only about half of reports of serious side effects submitted to the FDA by manufacturers met basic standards for completeness, including a patient’s age, sex and the date the event took place. When the FDA itself collects side-effect information, 85 percent of reports met the basic standards, according to the New York Times. But the drug makers’ reports constitute close to 97 percent of all adverse events collected by the system. Details like the patient’s age and sex are important in evaluating how different groups of people might react to a particular drug.

The FDA’s adverse-event reporting system is the major information source for other drug safety experts to track problems with medicines that have entered the marketplace, according to the Times. But such reports account for only a fraction of the actual adverse events caused by prescription drugs because reporting by patients and doctors is voluntary. Drug makers are required to notify the FDA of adverse events reported for any of their drugs.

Thomas J. Moore, a senior scientist at the Institute for Safe Medication Practices and lead author of the report, said that some drug companies —Vertex Pharmaceuticals, Biogen Idec and Amgen — consistently submit high-quality reports. Others perform well below average in their reporting, including generic drug manufacturer Par Pharmaceutical, and Cubist Pharmaceuticals. Moore said it "feasible to do reasonably complete reports," and he attributed low quality reporting to "lack of due diligence by the manufacturers," according to the Times.

A spokesman for the FDA acknowledged the frequent incompleteness of adverse-event reports, but said it is "challenging" to improve the system because of the voluntary nature of much of the reporting. The FDA has launched several initiatives to use data-mining techniques to better analyze the reports and it is ramping up the Sentinel Initiative, which uses information from sources like insurance claims data to identify potential problems, the Times reports.

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