Health and drug-safety surveillance: There’s an app for that!
The FDA’s (Food and Drug Administration) decision to restrict access to the diabetes drug Avandia due to safety concerns is landing the issue of post-market drug surveillance in the headlines again. In Europe the drug has been pulled from the market, and US health and consumer advocates aren’t happy with the FDA’s decision to leave it on the market.
"The evidence we have to date does not support the use of Avandia as a first, second, or even third line drug for treating type 2 diabetes," John Santa of Consumer Reports tells the Washington Post. "This latest effort on the part of the FDA to deal with a drug that's unsafe will only confuse consumers. “
Dr. Santa’s concerns are well placed. Many folks don’t realize the FDA only receives reports of as few as 1% of all adverse drug events. Despite the toll-free phone numbers listed on drug labels, the FDA’s website, and other marketing efforts, the vast majority of drug side effects are never recorded. This means that every time we hear reports that a certain number of people have been harmed by a drug, the number may undercount the true magnitude by 99%. Can an iPhone app harness the power of crowdsourcing to help change that? We may soon find out. (Other mhealth surveillance tools include DataDyne's Episurveyor.)
Boston Children’s Hospital (BCH) and University of North Carolina’s Gillings School of Global Public Health collaborated on the creation of MedWatcher, an iPhone app that allows to you fill out and submit an adverse drug event claim form directly to the FDA's MedWatch program. They’ve significantly reduced the hassle –factor involved in filling out the normal FDA-approved forms, with the hopes that it’ll inspire more people to submit reports, and expand the effective reach of post-market drug surveillance efforts. The app also allows you to search the FDA MedWatch site for safety-related drug alerts.
MedWatcher, available for free at the iTunes App Store, isn’t the first crowdsourceing tool developed by BCH. Last year their HealthMap team introduced “Outbreaks Near Me” for iPhone and Android, which allows folks to report incidents of infectious disease, and maps such reports.