Pharmacovigilance and safety

Abstract

All medicines undergo clinical trials to evaluate their efficacy and safety before commercialization; however, these studies have limitations in detecting rare, long-term, or group-specific adverse events. In this context, pharmacovigilance becomes essential, as it enables continuous monitoring of medicines under real-world conditions. It encompasses a set of activities aimed at the detection, assessment, understanding, and prevention of adverse events, promoting risk communication and contributing to the safe and rational use of medicines and vaccines. This review highlights pharmacovigilance as a fundamental component of healthcare, essential for protecting public health. A documentary research of a qualitative nature was conducted, based on indirect sources and bibliographic material, using a narrative literature review approach. The data show that clinical trials are essential for evaluating the initial efficacy and safety of medicines and vaccines, but they have limitations, especially in identifying rare, delayed, or group-specific adverse reactions. Therefore, pharmacovigilance is crucial, as it allows monitoring under real-world use and the detection of new risks. In addition to reporting adverse events, pharmacovigilance involves identifying, analyzing, and preventing medicine-related problems, with the participation of multiple stakeholders. Nevertheless, determining the causality of adverse reactions remains challenging, reinforcing the importance of strengthening these systems, training professionals, and informing the public to ensure safer use of medicines.