Details
This report describes 1) a review of the literature concerning algorithms for identifying specified cohorts in which exposure to medical countermeasures will more likely result in adverse outcomes, and 2) recommends algorithms to identify these cohorts for use in future surveillance activities. The report focuses on algorithms for 15 cohorts identified by FDA as relevant to medical countermeasures for use with Mini-Sentinel Prospective Routine Observational Monitoring Program Tools (PROMPT).
The Addendum provides detailed information concerning algorithms identified in the literature review.
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Contributors
Charles E. Leonard, PharmD, MSCE; Center for Clinical Epidemiology and Biostatistics, and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Cristin P. Freeman, MPH, MBE; Hanieh Razzaghi, MPH; Center for Clinical Epidemiology and Biostatistics, and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Ryan M. Carnahan, PharmD, MS, BCPP; Elizabeth A. Chrischilles, PhD, MS; Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City, IA
Susan E. Andrade, ScD; Meyers Primary Care Institute, a joint endeavor of Fallon Community Health Plan, Reliant Medical Group, and University of Massachusetts Medical School, Worcester, MA
Allison Naleway, PhD; The Center for Health Research Northwest, Kaiser Permanente, Portland, OR
Robert Penfold, PhD; Group Health Research Institute, Seattle, WA
Gregory E. Simon, MD, MPH; Group Health Research Institute and Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA
Patrick Archdeacon, MD; Office of Medical Policy, Center for Drug Evaluation and Research, FDA, Silver Springs, MD
Faith Barash, MD, MPH, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD
Monika Houstoun, PharmD, BCPS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD
David Menschik, MD, MPH; Division of Epidemiology, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD