According to a study by a group that tracks drug safety issues, the main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed because drug makers are submitting incomplete information about problems to the Food and Drug Administration (FDA).
The Institute for Safe Medication Practices found that only about half of reports of serious side effects submitted to the FDA by manufacturers met basic standards for completeness, containing a patient’s age, sex and the date the event took place. Reports collected by the FDA itself met basic standards in 85 percent of cases, the New York Times reports. Drug makers’ reports account for close to 97 percent of all adverse events collected by the system. Details such as the patient’s age and sex can be important in evaluating a drug and how different groups of people might react to it.
The FDA’s adverse-event reporting system is the major way that the agency and other drug safety experts track problems with medicines after they have entered the marketplace, according to the Times, but these reports account for only a fraction of the actual adverse events caused by prescription drugs. Patient and doctor reporting of serious side effects is voluntary, but drug makers are required to notify the FDA if they become aware of an adverse event caused by a drug they manufacture.
Lead author Thomas J. Moore, senior scientist at the Institute for Safe Medication Practices, said that some companies — including Vertex Pharmaceuticals, Biogen Idec and Amgen — consistently submitted high-quality reports but others, including Par Pharmaceutical, a generic drug manufacturer, and Cubist Pharmaceuticals, performed well below average. “We know it is feasible to do reasonably complete reports,” Moore said. He attributed low quality reporting to “lack of due diligence by the manufacturers,” according to the Times.
An FDA spokesman acknowledged that adverse-event reports were often incomplete. Improving the system “is challenging because of the voluntary nature of the reporting.” The agency is working on several initiatives to use data-mining techniques to better analyze the reports, and is also ramping up the Sentinel Initiative, which uses information from sources like insurance claims data to identify potential problems, the Times reports.