Proactive Postmarketing Surveillance: Overview and Lessons Learned from Medication Safety Research in the Veterans Health Administration

This report is an overview of the medication safety studies conducted by the VISN (Veterans Integrated Service Network) 8 Patient Safety Center of Inquiry (PSCI), Tampa, FL, over the past 5 years. The Center has been developing the research capacity to conduct national Veterans Health Administration (VHA) proactive medication safety surveillance studies as part of its research focus on patient falls and mobility issues in elderly veterans. The Center’s research findings describe new directions and alternative approaches based on a paradigm shift in how proactive medication safety surveillance can be conducted using the VHA’s comprehensive health care utilization data. These studies are primarily hypothesis-generating and enhanced signal-detection studies on a national level. The lessons learned from the Center’s studies may help to inform the current Congressional debate on Food and Drug Administration (FDA) legislation Prescription Drug User Fees Act (PDUFA IV) that affects the nature and rigor of U.S. postmarketing drug safety studies.