FDAnews Drug Daily Bulletin


April 19, 2006

The current adverse event reporting system is too passive to ensure drug safety, researchers say. Instead, a more active system involving insurance data mining, further analysis of electronic medical records and population-based databases is necessary to have a thorough post-approval monitoring system.

The current voluntary post-approval drug safety system does not ensure that sufficient data are available to head off most adverse events in prescription drugs, David Ridley, a professor at Duke University's Fuqua School of Business, and Hugh Tilson, a professor at the University of North Carolina's School of Public Health, told FDAnews.

Because current adverse reporting is voluntary, there are selection limitations that make this data less useful in predicting serious adverse events, Ridley said. People can decide what information to provide to the FDA, which usually leads to only unexpected side effects and data on new drugs being submitted to the agency's Adverse Event Reporting System, he added. Data on increases in side effects in older medicines may be lacking, Ridley added.

A new system that actively obtains information from insurance claims data and other sources will encompass a wider range of side effects than a voluntary system, Tilson said. The "advent of automated claims databases and now electronic medical records brings such responsible public health monitoring within our reach," he added. These data should be used as the basis for additional post-approval clinical trials to study the signals obtained from data mining and the adverse event reports, Ridley added.

The researchers will soon present this recommendation, along with their newly released data on the current amount that companies spend on post-approval drug safety, as part of an effort to inform an ongoing Institute of Medicine (IOM) report on the federal drug safety system, Ridley said. IOM's report is scheduled for release in July.

While the researchers published a report assessing current industry investment in drug safety, this is only a baseline for necessary future changes, Tilson said. "Whether we spend enough, too little, or too much isn't the right question. We need to have the systematic review and re-engineering now promised from IOM to guide our efforts."

The report, which was recently published in Health Affairs, found that drug companies spent a total of $800 million on post-approval drug safety in 2003. This money was spent to implement spontaneous reporting of side effects, which is later entered into the FDA's reporting system.