FDA Hopes to Improve Drug-Safety Monitoring Through IT
The growing use of IT in the healthcare system -- including through electronic prescribing and electronic medical records -- could significantly boost the FDA's ability to monitor drug safety, according to a top agency official.
The FDA has two ongoing IT pilot projects that aim to identify adverse drug safety signals sooner and more efficiently than is now possible, said Paul Seligman, director of the FDA's Office of Pharmacoepidemiology and Statistical Science.
The first initiative involves using data-mining techniques to analyze the clinical databases of the Harvard Pilgrim health network in Boston. Investigators hope to tease out the data and identify adverse events associated with drugs and biologics used in the network, Seligman said. The second project uses the U.S. Consumer Product Safety Commission's National Electronic Injury Surveillance System to gather and track adverse drug events in 60 hospital-based emergency rooms nationwide. Under this project, the FDA is starting to identify what kinds of drugs are causing the adverse events, as well as the nature and seriousness of those events, he said.
Such IT systems could eventually pick up adverse events that have not yet been reported, and identify safety signals sooner than is possible under the current system, Seligman said. The FDA's current safety monitoring system relies on busy healthcare providers to actually sit down and fill out a form, he said. "That is one of the weaknesses of our system," Seligman said, noting the hope is to rely less on human reporting and more on the medical data that has been accumulated in the course of clinical encounters that characterize drug safety.