Healthy Skepticism Library item: 7664

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Subramaniam V, Schmid J.
Patient safety and regulatory initiatives through drug quality monitoring: Perspectives from the Food and Drug Administration
International Pharmaceutical Federation World Congress 2002; 62:(9):

Abstract:

Problems in patient safety have recently been a focus among health professionals and patients and are often a result of human error and the systems in place. Pharmacists have been challenged to increase their awareness of processes known to reduce medical errors and to contribute to interdisciplinary problem solving, including off-label uses and the potential for the emergence of adverse events and drug quality problems in new patient groups. One aspect of pharmacists’ contributions is exemplified in FDA’s Drug Quality Reporting System (DQRS), through which voluntary safety information is disseminated through MedWatch, i.e. drug quality complaints in labeling, packaging and manufacturing of drug products. These reports may result in medical errors, adverse events and safety concerns for patients. Possible FDA regulatory or administrative actions to ensure patient safety may include voluntary corrective actions (i.e. recalls), Untitled Letter, Warning Letter, withdrawal of an approved application, seizure, injunction, or prosecution. It may take only one safety report to initiate an FDA investigation that may result in a company’s recall of a product from the marketplace because of poor quality. DQRS reports are classified by reporter sources (pharmacists, physicians, nurses), number of reports, types of product defects (packaging, labeling, manufacturing), and corrective outcomes (voluntary corrective actions, market withdrawals, product recalls). Problems include product stability, container defects, contamination, precipitation, discoloration, lack of effectiveness, and tampering. Followup by FDA between 1995 and 2001 resulted in 74 product recalls, 3 market withdrawals and 184 voluntary corrective actions. These DQRS safety initiatives disseminated through FDA’s MedWatch Program may not generally be detected during the pre-market drug approval process or an FDA investigation. Proactive reporting by pharmacists has enhanced FDA’s partnerships with the pharmaceutical industry to assure the quality and safety of marketed drugs.