Details
This report 1) describes a review of the literature for algorithms used in administrative data environments to identify FDA-prioritized health outcomes that may be related to medical product and/or medical countermeasure exposure, and 2) recommends algorithms to identify these outcomes for use by Mini-Sentinel Prospective Routine Observational Monitoring Program Tools (PROMPT) in future surveillance activities.
Contributors
Sean Hennessy, PharmD, PhD; 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 Freeman, MPH, MBE and 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
Patrick Archdeacon, MD; Office of Medical Policy, Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Ryan Carnahan, PharmD, MS, BCPP and Elizabeth Chrischilles, MS, PhD; Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City, IA