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

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  • Alternative Title:
    Online J Public Health Inform
  • Description:
    Objective To conduct an initial examination of the potential use of BioSense data to monitor and rapidly assess the safety of medical countermeasures (MCM) used for prevention or treatment of adverse health effects of biological, chemical, and radiation exposures during a public health emergency. Introduction BioSense is a national human health surveillance system for disease detection, monitoring, and situation awareness through near real-time 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). Methods To provide a preliminary assessment of the use of BioSense for this purpose, we reviewed selected publications evaluating the use of electronic health records (EHRs) to monitor safety of drugs and vaccinations (medications), focusing particularly on systematic reviews, reviewed BioSense data elements, and consulted with a number of subject matter experts. Results More than 40 studies have examined use of EHR data to monitor adverse effects (AEs) of medications using administrative, laboratory, and pharmacy records from inpatient- and out-patient settings, including EDs (2–4). To identify AEs, investigators have used diagnostic codes; administration of antidotes, laboratory measures of drug levels and of biologic response, text searches of unstructured clinical notes, and combinations of those data elements. BioSense ED data include chief complaint text, triage notes, text diagnosis, as well as diagnostic and medical procedure codes. Conclusions These findings suggest that BioSense data could potentially contribute to rapid identification of safety issues for MCM and that some methods from published research could be applicable to the use of BioSense for this purpose. However, such use would require careful development and evaluation.
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