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ISDS 2012 Conference Abstracts

Use of BioSense for Rapid Assessment of the Safety of
Medical Countermeasures
Ralph J. Coates* and Kathleen Gallagher

Division of Notifiable Diseases and Healthcare Information, Centers for Disease Control and Prevention, Atlanta, GA, USA

Objective
To conduct an initial examination of the potential use of BioSense

data to monitor and rapidly assess the safety of medical countermea-
sures (MCM) used for prevention or treatment of adverse health ef-
fects of biological, chemical, and radiation exposures during a public
health emergency.

Introduction
BioSense is a national human health surveillance system for dis-

ease 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, vaccina-
tions, 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 vac-
cinations (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, labora-
tory, and pharmacy records from inpatient- and out-patient settings,
including EDs (2-4). To identify AEs, investigators have used diag-
nostic 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 in-
clude chief complaint text, triage notes, text diagnosis, as well as di-
agnostic and medical procedure codes. 

Investigations used a variety of study designs in various popula-
tions and settings; examined a wide range of medications, vaccina-
tions, and AEs; and developed a diverse set of analytic algorithms to
search EHR data to detect and signal AEs (2-4). Most research has
been done on FDA-approved medications. Most studies used EHR
data to identify individuals using specific medications and then
searched for potential AEs identified from previous research. None of
the studies investigated use of EHR data to monitor safety when
records of an individual’s medication use could not be linked to that

individual’s records of AEs. BioSense data could be used for AE de-
tection, but linking AEs to MCM use would require follow-back in-
vestigation. Since there is limited research on AEs of some MCM,
there would be limited information to guide identification of poten-
tial AEs. 

Performance characteristics of the AE monitoring systems have
been mixed with reported sensitivities ranging from 40-90%; speci-
ficities from 1% to 90%, and positive predictive values from < 1% to
64%, depending on the medication, AE and other characteristics of
the study (2, 4). However, the small numbers of studies with com-
mon characteristics has limited the ability of reviewers to determine
which types of systems have better performance for different med-
ications and AEs.

Some experts suggest that data in BioSense, might contribute to
safety surveillance of MCM. They also caution that poor predictive
values and high rates of false positives reported in the literature raise
concerns about burden to those conducting investigations in response
to AE alerts, particularly in the context of a public health emergency.

Conclusions
These findings suggest that BioSense data could potentially con-

tribute 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.

Keywords
BioSense; countermeasures; safety; monitoring; medical

References

1. National Biodefense Science Board. Where are the countermeasures?
Protecting America’s health from CBRN threats. U. S. Department of
Health and Human Services, March, 2010.

2. Forster AJ, et al. A systematic review to evaluate the accuracy of elec-
tronic adverse drug event detection. JAMIA 2012;29:31-38. 

3. Lucado J, et al. Medication-related adverse outcomes in U.S. hospitals
and emergency departments, 2008. HCUP Statistical Brief # 109.
AHRQ, 2011.

4. Handler SM, et al. A systematic review of the performance character-
istics of clinical event monitor signals used to detect adverse drug
events in the hospital setting. JAMIA 2007;14:451-8.

*Ralph J. Coates
E-mail: rjc5@cdc.gov

Online Journal of Public Health Informatics * ISSN 1947-2579 * http://ojphi.org * 5(1):e85, 2013