Adverse event reporting in the digital environment

21st May 2012 by Sally Leon

This blog post has been created to support a tweetup that the medDigital team are conducting for an upcoming PIPA Conference workshop.

Ever since the thalidomide disaster of the 1960s, pharmacovigilance has been high on the agenda of global health organisations and the pharma industry. Today, pharma companies have a legal obligation to collect and report adverse events in a timely manner.

Industry guidelines usually state that once a pharma company, or representative thereof, becomes aware of a potential adverse event report, appropriate action should be taken by the next working day. This is to ensure that the adverse event is reported to the regulatory authorities within legally required timelines.

As so much of our communication now takes place online, this has important implications for the review, certification, and monitoring of digital activities, particularly those that allow free text entry such as website contact forms, Facebook pages, Twitter feeds etc. Guidance is available in the PMCPA's Digital Communications document on collecting and reporting adverse events identified on pharma-sponsored sites.