'MedWatcher' app aims at boosting adverse events reporting

Researchers at Children's Hospital Boston in collaboration with the University of North Carolina at Chapel Hill have developed "MedWatcher," a new iPhone application that provides drug safety surveillance in real-time.

MedWatcher allows users to track the latest drug safety updates provided by official alerts from the Food and Drug Administration (FDA), as well as news from informal channels such as the media. It also enables users to report information about drug side effects and view reports of adverse events submitted to the application by patients and physicians.

The new app incorporates information about thousands of medications listed in FDA databases and enables users to customize the app based on their medications of interest. As drugs are selected in the app, users are able to view alerts that have been generated by the FDA, create news feeds about a particular drug, and set preferences to receive future alerts and news about those medications. Users are also able to see reviews by patients and providers, and may choose to submit a review as a patient/clinician themselves about adverse events they, or their patient, may have experienced.

"Traditional voluntary drug safety surveillance is limited by substantial under-reporting," said John Brownstein, PhD, director of the Computational Epidemiology Group within the Informatics Program at Children's Hospital Boston (CHIP), who co-led the development of the application with Clark Freifeld, research software developer at CHIP, and Nabarun Dasgupta, PhD student at the University of North Carolina Gillings School of Global Public Health. "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," said Freifeld.

Researchers developed two unique, highly-structured, user-friendly forms 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 the data contained in the app will come from official and unofficial sources, users are encouraged to interpret the data appropriately.

"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," said Dasgupta. "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."

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