Boston, MA – Physicians in the United States report less than one percent of adverse drug events to the FDA. To address this issue, researchers at Brigham and Women’s Hospital (BWH) implemented an automated adverse drug event reporting functionality in electronic health records in a proof-of-concept study. The findings show that the use of the automated system drastically increases physician reporting of adverse drug events and has the potential to significantly improve the amount and quality of data reported to the FDA. This research is published online and in upcoming issue of Pharmacoepidemiology and Drug Safety.
“Our goal was to lower the burden for clinicians to report adverse drug events by incorporating the process into the electronic health record. In this study, we show that clinicians are open to participating in automated reporting, and by doing so they both increase efficiency and increase patient safety,” said Jeffrey Linder, a physician and researcher in the Department of General Medicine and Primary Care at BWH and lead author of the paper.
Between December 2008 and May 2009, researchers implemented a pilot program for 26 practicing physicians to test an electronic health record-based tool that automated adverse drug reporting to the FDA. During that time, 217 reports were generated and sent to the FDA through the tool. A survey from 21 of the same physicians indicated that in the year previous to implementation of the tool, they submitted zero reports. Clinicians also reported that the technology saved time, taking less than one minute to complete and send notification of an event, when compared to other methods of reporting. Clinicians also indicated that integration of the reporting into their workflow in the electronic health record was beneficial and that they recognized that increased reporting through the use of the tool had the potential to improve the care they provide to patients.
“We were excited to learn that this automated reporting can be accommodated and is beneficial to clinicians,” said Linder. Our next steps are to expand the use of this technology to test its effectiveness more broadly within our current system and also in other electronic health record technologies.”
This study was supported by a grant from Pfizer.