New iPhone application tracks drug safety updates

Researchers at the University of North Carolina at Chapel Hill and Children's Hospital Boston have developed a new iPhone application to encourage health-care professionals and patients to send and receive information about the use and side effects of prescription medications.

The application, MedWatcher, allows users to track the latest drug safety updates provided by official alerts from the Food and Drug Administration (FDA) and related news from the media and other sources. Users can also report information about drug side effects and view reports of adverse events that other users, such as patients and physicians, submit to the application.

Designed as an easy-to-use tool to enhance and support ongoing drug safety efforts, MedWatcher incorporates information about thousands of medications listed in FDA databases and enables users to customize the app to provide information about specific medicines.

The development of the application was co-led by John Brownstein, Ph.D., director of the computational epidemiology group within the informatics program at Children's Hospital Boston, along with Clark Freifeld, research software developer at the program, and Nabarun Dasgupta, epidemiology doctoral student at UNC's Gillings School of Global Public Health.

Dasgupta said traditionally, reporting adverse events has been a cumbersome and lengthy process - for clinicians who have had to interrupt their workflow to submit information, and for patients who are unsure of the process.

"In making this an easy-to-use mobile app, we aim to lower that barrier and reach people where they live and work, ultimately improving the performance of drug safety surveillance and enhancing our signal detection capabilities," he said.

Brownstein said traditional voluntary drug safety surveillance was limited by substantial under-reporting. "High profile failures to detect safety problems during the pre-approval period have brought new intense scrutiny on the drug approval process and underscore the need for additional methodologies and data sources to monitor drug safety."

"Our hope is that through the release of MedWatcher, we will prompt increased participation in surveillance, empowering people to participate in the public health process but also potentially allowing us to 'crowdsource' problem drugs which will lead to better understandings of side effects of medicines, and possibly even bring about earlier detection and prevention," Freifeld said.

Two unique, user-friendly forms were created to support the reporting function of the app and are geared toward clinicians and patients, respectively. Reports of serious adverse events are reviewed by members of the Children's computational epidemiology group and then submitted to the FDA and displayed in the app. Recognizing that data in the app will come from official and unofficial sources, users are encouraged to interpret the data appropriately.

MedWatcher builds on the surveillance technology efforts of the HealthMap team at Children's, which last year released "Outbreaks Near Me," an application for the iPhone and Android phone that tracks, maps and encourages reporting of incidents of infectious disease.