Postmarketing drug surveillance is vital to reporting adverse drug events (ADE) to the US Food and Drug Administration (FDA) and Department of Veterans Affairs (VA) Center for Medication Safety. A cornerstone of this approach is the collection and evaluation of reports of ADEs through voluntary reporting by healthcare professionals. The safety profile of a drug evolves over time as new information is discovered on a drug with its use in larger populations and subgroups not previously studied during clinical trials. ADE reports contribute to drug safety by triggering signals of potential problems that may lead to heightened awareness of drug reactions and further promote interdisciplinary problem solving of the drug's safety and attributes between pharmacists, physicians, nurses and other healthcare professionals.
VA has developed an integrated web‐based application that fully automates the adverse drug event (ADE) reporting process (including direct submission to the FDA's MedWatch program) through a single portal for all VA facilities. For more information on ADE use the following links:VA Drug Event Reporting System
Date Posted: April 2012