One of pharma's biggest concerns with social media is adverse event (AE) reporting. But for an AE to be reportable, it must meet the four criteria: 1) an identifiable patient, 2) an identifiable reporter, 3) a suspect drug, and 4) the side effect. Most often online, #1 and #2 aren’t met. Last year, Nielsen even produced a report quantifying this.
To handle AE reporting responsibly, companies that have created a presence in a social media property -- such as JnJ's Health YouTube Channel -- monitor their comments before posting in order to route any AEs appropriately. Some properties, like Facebook, don't allow for monitoring of comments before posting to the Wall, so companies may choose to turn off that feature. Not great for engaging with their audience, but it does avoid the risk.
This week, UCB announced a partnership with PatientsLikeMe to launch an epilepsy-focused patient community, and will report adverse events to the FDA through round-the-clock surveillance. The community is expected to launch in early 2010 and is designed to to collect, analyze and reflect information received from people with epilepsy, regardless of their diagnosis, prognosis or treatment regimen.
Sounds like a great step towards transparency and providing patients and the pharmaceutical company with valuable information and tools while maintaining FDA regulations.