Postmarketing

Postmarketing refers to the monitoring, evaluation, and study of a medical product after it has been released to the market. It includes post-authorization safety studies, postmarketing surveillance, and ongoing pharmacovigilance activities aimed at detecting, assessing, understanding, and preventing adverse effects or other risks associated with a product.

Purpose and scope

After approval, additional safety and effectiveness information may emerge from broader patient populations and longer exposure. Postmarketing activities seek to characterize the frequency and severity of adverse events, identify risk factors, monitor real-world effectiveness, and inform risk-benefit decisions. They also support label updates, guidance to healthcare professionals, and risk communication to patients.

Regulatory framework and practices

Regulators often require manufacturers to conduct postmarketing surveillance and to submit periodic safety reports and post-authorization studies. Pharmacovigilance systems collect and analyze data from spontaneous reports, electronic health records, claims databases, and patient registries. These activities may lead to changes in labeling, restricted use, additional warnings, or, in some cases, market withdrawal.

Methods and challenges

Common methods include spontaneous adverse event reporting, active safety surveillance, cohort or case-control studies, and drug or device registries. Challenges include underreporting, incomplete data, confounding factors, and time lags, all of which can affect the reliability of safety signals.

Overall, postmarketing plays a critical role in continuing assessment of a product’s safety profile after market release.