Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US

Epidemico and representatives from a patient group, Essure Problems, co-authored a publication describing the use of Facebook outreach and the MedWatcher app to encourage adverse event reporting to the US FDA for Essure, a hysteroscopic sterilization device. Over 1,300 valid reports were received through the app over approximately 19 months, which amounts to over 15 times more reports than through traditional channels. Further, these reports were more than 4 times as likely to be “well-documented” according to WHO’s VigiGrade standards. A report took on average 11 minutes to submit, compared to 40 minutes estimated for the traditional FDA MedWatch form. Factors that encouraged group members to submit reports were highlighted, applying the Motivation-Incentive-Action-Behavior model for successful crowdsourcing.

Our findings show that by coupling an easy-to-use mobile tool with online community outreach, a high volume of well documented reports were received. This shows that beyond providing support and information to its members, patient groups can also provide meaningful and valuable data for safety reviewers and regulatory agencies.

View the open access article published in Pharmaceutical Medicine

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