Use of BioSense for Rapid Assessment of the Safety of Medical Countermeasures

Introduction BioSense is a national human health surveillance system for disease detection, monitoring, and situation awareness through near realtime access to existing electronic healthcare encounter information, including information from hospital emergency departments (EDs). MCM include antibiotics, antivirals, antidotes, antitoxins, vaccinations, nuclide-binding agents, and other medications. Although some MCM have been extensively evaluated and have FDA approval, many do not (1). Current FDA and CDC systems that monitor drug and vaccine safety have limited ability to monitor MCM safety, and in particular to conduct rapid assessments during an emergency (1).