A recent study has shown that by using a mobile app the time taken to prepare and submit a voluntary adverse event (AE) report can be reduced significantly. The study also showed that reports received via the mobile app were considered “well documented” 55.9 % of the time, compared with an international average of 13 % for all medical products and on average, there were 15 times more reports submitted per month via the app.
A patient community on Facebook adopted the FDAs MedWatcher app to submit reports involving a hysteroscopic sterilization device. After agreeing on key reporting principles, group administrators encouraged patients to report via the app. Semi-structured forms in the app mirrored fields of the MedWatch 3500 form and reports were transmitted to the FDAs database via an electronic gateway, and anonymized versions were posted in the app. Data collected from May 11, 2013 to December 7, 2014 were analyzed. Narrative texts were coded by trained and certified MedDRA coders (version 17). Descriptive statistics and metrics, including VigiGrade completeness scores, were analyzed. Various incentives and motivations to report in the Facebook group were observed.
The conclusions from the study were that outreach via an online patient community, coupled with an easy-to-use app, allowed for rapid and detailed Adverse Event reports to be submitted, with gains in efficiency. Two-way communication and public posting of narratives led to successful engagement within a Motivation-Incentive-Activation-Behavior framework, a conceptual model for successful crowdsourcing. Reports submitted by patients were considerably more complete than those submitted by physicians in routine spontaneous reports. Further research is needed to understand how biases operate differently from those of traditional pharmacovigilance.
For more information on adverse event reporting apps click here.