Drug Quality Reporting System, Annual DQRS Report: 1993

摘要

The US Food and Drug Administration (FDA) established a voluntary reportingsystem in 1971 called the Drug Quality Reporting System (DQRS). The program is administered by FDA's Center for Drug Evaluation and Research (CDER) and relies on health care providers to exercise their professional responsibility by reporting drug product defect concerns to FDA. DQRS is one of the programs under the MEDWATCH Agency-wide reporting umbrella, and has been able to maintain its toll free telephone number (1-800 FDA-1088) established in 1988, for the Nation's pharmacists and other health care professionals to continue the direct reporting of drug product quality issues as well as other MEDWATCH reporting concerns. The associated product manufacturers or labelers are provided copies of their DQRS reports free of charge, and they or the FDA can then investigate reports either in concert or independently. The value of the information provided through this voluntary reporting system has been demonstrated over time by its savings in investigational time and in the ability to discover a drug quality problem quickly. Over the years, this program has provided FDA and the pharmaceutical industry with product information that has resulted in the correction of drug product quality or, when necessary, the removal of a product from the market.