Critique of a Key Drug Safety Reporting System
The U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS)—based on MedWatch reports–is the government’s primary safety surveillance system designed to identify harms from therapeutic drugs. For the last six years these vital data have formed the core of ISMP’s QuarterWatch™ drug safety reports. In this issue we decided to look closely at the system itself. Our conclusion: it seems clear that this drug safety monitoring system is in need of modernization. It suffers from a flood of low quality reports from drug manufacturers and has not yet been updated for the changing environment in which drugs are marketed to health professionals and consumers. We discuss key problems and offer some recommendations as an organization that relies heavily on data collected through FAERS.
QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP) that monitors adverse drug events reported to the FDA. We analyze computer excerpts from the FDA Adverse Event Reporting System (FAERS) that are released for public research use. These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of therapeutic drugs after FDA marketing approval.