Study: EHRs boost docs' reporting of adverse drug events

October 18, 2010 | Molly Merrill, Associate Editor

BOSTON – Electronic health records increase physician likelihood of reporting adverse drug events to the FDA, according to a new study by researchers at Brigham and Women's Hospital (BWH).

Currently, physicians in the Unites States report less than one percent of adverse drug events to the FDA. In order to address this problem, BWH implemented an automated adverse drug event reporting functionality in EHRs in a proof-of-concept study, which was supported by a grant from Pfizer.

The study's 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. The 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."

Reader Comments (3)Login to Post a Comment

ProfessorM says: I spoke on mHealth and HIT at

October 25, 2010 | 1:38PM GMT

I spoke on mHealth and HIT at a CDRH town hall on Oct. 7th in Irvine, CA, and touched on the role that social networking will play in reporting and outcomes assessment. The reality is that marketing has already begun to shift from company to physician, to company to patient. In the future, companies will find it far more beneficial in marketing to patients, with patients having increased decision-making in their own care. Social Networking sites like Facebook will allow mfrs to not only market, but obtain valuable feedback from patients which physicians have largely not been providing.

The above report is encouraging. But the current "less than one percent" reporting figure is a sad commentary on QA in the U.S. Let's fix this!

Stephen Dolle
Newport Beach, CA

drdanh says: Using technology to advance practice

October 18, 2010 | 8:05PM GMT

Finally we have an opportunity to update the adverse events listed for most medications. The list is usually based on old, preclinical studies and don't reflect real-world practice. Hopefully we can start catching the next Vioxx earlier, and leave some of the metformin/CHF controversies in the past.

skater1 says: Increased Reporting

October 18, 2010 | 12:27PM GMT

This really lends credibility to the fact that if you build reporting or any action that you desire from a provider/clinician into their workflow, the likelihood of compliance is exponentially increased. Also building the reporting from one place instead of having the provider/clinician go to multiple applications in order to complete the reporting. One stop shopping is very convenient and it is an efficient way for providers to work.