The U.S. Food and Drug Administration's system for tracking prescription drug side effects is dangerously incomplete, according to a new study.
The study, published Jan. 28 by the Institute for Safe Medication Practices, found that the FDA's Adverse Event Reporting System receives inadequate information from the drug manufacturers and lags behind in the changing environment of drug marketing. The study concluded "it seems clear that this drug safety monitoring system is in need of modernization."
The FAERS system is updated on a voluntary basis in which consumers and health professionals offer information about any case where a prescription may have caused harm. However, the manufacturer reports are frequently incomplete, only documenting some of the FDA's required information. The ISMP found that only approximately 49 percent of manufacturer reports met the FDA's standard of completion.
Additionally, the report found that the FAERS system covers newer medication but neglects older generic drugs and drug-related adverse events in newborns and children. The vast majority of reports are for negative side effects in new drugs, but 86 percent of outpatient prescriptions are for generic drugs, according to the study.
A spokesman for the FDA told the New York Times the agency is using better data-mining techniques to analyze the reports and increasing efforts on the Sentinel Initiative, which uses third-party reports, such as insurance claims, to check for potential issues.