When social media first entered the lexicon of pharmaceutical marketers a primary concern was the burden of adverse event reporting. The thought was that increased conversation and engagement would result in an unmanageable volume of reportable adverse events.
Many, including myself, did our best to quell those fears. There are essentially two lines of reasoning when calming the nerves of the safety department at a pharmaceutical company:
1.) People don’t want to report AEs using social media channels. There is a line of reasoning that says most people would prefer to follow traditional channels to report an AE and not take to the public forums of social media. The idea is that there won’t be an influx in AE reporting because that’s not the intent or spirit of social media.
2.) The other and more commonly used line of reasoning is that the data shows that the 4 criteria that constitute a reportable adverse event are rarely met online.
Folks like BuzzMetrics and Jonathan Richman have done phenomenal work to illustrate the validity of this point. The fact is; reportable AEs are rare in social media channels. It’s a compelling storyline: increased conversation does not have a direct correlation to increased adverse events.
Again, the data bears this out. However, it doesn’t fully reflect the reality of the pharma landscape. Recent conversations I’ve had have hammered home a point that has long been apparent. For the safety departments at pharmaceutical companies, the fears of adverse event reporting were never about “reportable” AEs, they were about acknowledging the realities of their job function. That reality means the safety department has to handle all possible AEs that come in through social media channels, not just the ones that are reportable. This is where the overwhelming burden starts to become tough to manage. As the engagement goes up, so does the frequencies of “possible” AEs.
Any social media engagement for a pharmaceutical company necessitates a policy change on handling adverse events and almost certainly increases the burden on the safety department. This doesn’t mean you should shy away from social media entirely, but it does mean you need to acknowledge the task at hand for the folks in your safety department and work with them to enact effective policy change that mitigates the burden on any one department. Chances are a good number of the current operating procedures for adverse event reporting can be replicated for social media channels. Start by evaluating the current protocol and then fill in the gaps on the missing pieces for social media.
The good news is that more conversations (and even “possible” AEs) means more data. Contrary to popular opinion, most healthcare companies want to know when their product does not work as intended. Instead of trying to convince companies that the AE reporting burden doesn’t exist, let’s shift our attention to figuring out how to mitigate that burden most effectively.


The burden of AE reporting for pharma social media: NOT a Red Herring: http://bit.ly/gpWLix #socpharm
Well done, Chris! RT @prforpharma: The burden of AE reporting for pharma social media: NOT a Red Herring: http://bit.ly/gpWLix #socpharm
RT @PRforPharma: The burden of AE reporting for pharma social media: NOT a Red Herring: http://bit.ly/gpWLix #socpharm
Adverse Events in Pharma Social Media Not a Red Herring? http://ow.ly/4zp0c | PRforPharma <– Yr opinion? ^AS
AE reporting concerns more about resources required to handle them (via @andrewspong): http://bit.ly/i1eovf #fdasm #socpharm
RT @PRforPharma: Adverse Event Reporting in Pharma Social Media Not a Red Herring http://bit.ly/haVmK3
RT @PRforPharma: Adverse Event Reporting in Pharma Social Media Not a Red Herring http://bit.ly/haVmK3
Adverse Event Reporting in Pharma Social Media Not a Red Herring http://j.mp/hi1Iqx
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Adverse Event Reporting in Pharma Social Media Not a Red Herring http://t.co/lXPY511F