This webinar reviewed the FDA’s Mini-Sentinel pilot effectiveness in capturing information on individuals receiving a medical product in the context of a Medical Countermeasures (MCM) event, and link that information to relevant data in the Mini-Sentinel Distributed Database. The effort is intended to enhance the system’s capability to identify associated adverse events and safety issues. The project included field test and white paper components that assessed capabilities for data collection and linkage and evaluated broader issues, respectively.
Mini-Sentinel investigators and researchers from Denver Public Health, Kaiser Permanente Colorado, and the National Association of County and City Health Officials recently completed a field test that focused on developing capacity to assess safety outcomes of exposures to MCM (i.e., drugs and vaccines) when responding to a public health emergency. This field test determined whether patients who visited a primary care clinic in the Kaiser Permanente Colorado (KPCO) health care system could be uniquely identified by a mobile data collection system, which would link to their medical record with KPCO and ultimately be used for Mini-Sentinel public health surveillance. The investigators studied the mobile device’s capability to collect patient information and the accuracy of that information in linking to medical records and the Mini-Sentinel public surveillance databases.
Dr. Marsha Reichman, Senior Advisor and Scientific Lead for Surveillance Programs at the U.S. Food and Drug Administration, provided a brief description of the rationale for the medical countermeasures surveillance field test. Matthew F. Daley, M.D., Senior Investigator at the Institute for Health Research at Kaiser Permanente Colorado; Associate Professor of Pediatrics, University of Colorado School of Medicine, and Dr. Arthur Davidson, Director of Public Health Informatics, Epidemiology, and Preparedness at Denver Public Health, presented an overview of findings from the field test.
Marsha Reichman PhD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Matthew F. Daley MD; Institute for Health Research at Kaiser Permanente Colorado, Denver, CO, University of Colorado School of Medicine, Aurora, CO
Arthur Davidson MD, MSPH; Denver Public Health and Schools of Public Health and Medicine, University of Colorado Denver, Denver, CO