Drug safety surveillance (more formally, pharmacovigilence) is a serious and complex issue. Once a drug is FDA-approved and on the market, it needs to be constantly monitored for long/short-term side effects. That process is currently rigid: once observed conclusively, these effects are reported by providers to relevant authorities and disseminated back to all medical community (after some lag time) through literature or subscribed updates.

MedWatcher is a mobile application trying to streamline this process, and increase public (patient) participation in pharmacovigilence. FYI- it’s not out yet (some sources projected Aug 2010 release, but I couldn’t find it in iTunes), so all that is known is intended functionality.

The application will serve two major purposes. First, users can receive drug-related alerts through it, based on FDA MedWatch and less-formal sources (news, media etc.). FDA MedWatch may be a treasure-trove of information, but it’s not easy to use. You can subscribe to an RSS feed, get email or text messages about all drug-related warnings. With tens of thousands of drugs on the market, that is like drinking from a fire hose.

If you are a patient worried about your cholesterol-lowering Zocor or a cardiologist who wants to stay informed about statins in general, there needs to be a way to subscribe to only what you care about. I’m hoping that MedWatcher leverages a comprehensive drug-database like FDB, Medi-Span, Red Book etc. to lets users do exactly that.

The second major functionality is for users (both patients and provider) to submit side-effects through a lean process. They mention that serious side-effects will ‘automatically’ be submitted to FDA (rest probably become discussion topics on MedWatcher itself). The current FDA MedWatch online reporting process is cumbersome and a bit disconnected (who remembers to submit voluntary information after they have seen/experienced a side-effect?).  Having a user-friendly mobile application form would solve some of that.

I think the direct patient engagement is very promising in this niche space. The concept may run the risk of becoming yelp for drugs, but even yelp reviews hold useful information once you figure out how to get rid of the noise. By opening direct communication channel with patients, it has the potential to provide the same disintermediation that TrialX provides for clinical trials.