Adverse Drug Event Reporting: Awareness Is Not Enough

摘要

Most drugs are used in a larger and more heterogenous population after they are brought to market than initially was evaluated in preapproval trials. Postmarketing pharma-covigilance provides data that enhance the rational and safe use of medications. In particular, the safety profile of drugs is dynamic; new information is continually assessed regarding use and outcomes. Among postmarketing surveillance methods, national voluntary reporting systems are an important conduit for the collection of information about specific adverse events involving medications. In the United States, the Food and Drug Administration's (FDA) Med-Watch program collects voluntary reports from health care professionals and consumers about adverse drug reactions and errors related to drugs, biologies, nutritionals, and devices. Data regarding voluntary reports on adverse events associated with vaccines are collected via the Vaccine Adverse Event Reporting System (VAERS), a program co-sponsored by the FDA and the Centers for Disease Control and Prevention (CDC). Information about medication and vaccine errors are also collected via other voluntary programs founded by the Institute of Safe Medication Practices: Medication Errors Reporting (ISMP MERP) and National Vaccine Reporting Program (ISMP VERP). All programs allow for individuals to confidentially report an incident, for the analyses of data to identify potential trends and problems, and for the provision of information to the global health community for optimizing patient safety.