What Students Need To Know About FDA Post Marketing Drug Safety Surveillance.

Postmarketing surveillance is the monitoring of drug performance in clinical practice and the taking of appropriate action to improve patient safety. The action taken can range from changes in product labeling (e.g., dose regimen alterations, drug interaction alerts, warnings about previously unknown adverse effects) to product withdrawal from the market. Postmarketing surveillance (PMS) is defined as the identification and collection of information regarding drugs after their approval for use in a population. The population of potential users after a drug is released is very different from the population studied in the premarking phase of a drug’s approval. Despite the rigorous steps in the process of drug development, limitations exist. Pharmaceutical companies give out brochures or other promotional materials to physicians or consumers. The drug’s prescribing information must accompany promotional labeling. New drugs are patent protected when they are approved for marketing. This means that onl