Postmarketing surveillance

Postmarketing surveillance (PMS), also known as pharmacovigilance, is a part of the science of pharmacy that focuses on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems after a medicinal product has been authorized for sale.

Overview

Postmarketing surveillance is a crucial aspect of the pharmaceutical industry. It is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Because clinical trials are conducted before the full safety profile of the drug is known, postmarketing surveillance can further refine, or confirm or deny, the safety of a drug after it is used in the general population by large numbers of people who have a wide variety of medical conditions.

Purpose

The primary purpose of postmarketing surveillance is to identify previously unrecognized adverse events and to monitor the frequency of known adverse events. It also aims to identify risk factors which could indicate a patient's likelihood of experiencing an adverse event. This information is used to update the product's labeling, to inform the public about the risks of the drug, and to inform decisions about regulatory action.

Methods

There are several methods used in postmarketing surveillance. These include spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health databases.

Challenges

Despite its importance, postmarketing surveillance faces several challenges. These include under-reporting of adverse events, lack of standardization in data collection, and the difficulty of determining causality between a drug and an adverse event.

See also

• Pharmacovigilance
• Clinical trial
• Adverse event
• Pharmacy
• Medicinal product