farmacovigilanssia

Farmakovigilanssia, also known as pharmacovigilance, is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. It is a crucial component of drug safety monitoring throughout the entire lifecycle of a medicine, from development and clinical trials to post-marketing surveillance. The primary goal of pharmacovigilance is to identify potential risks associated with medicinal products and to implement measures to mitigate these risks, thereby ensuring the safe and effective use of medicines.

The practice of pharmacovigilance involves collecting and analyzing reports of suspected adverse drug reactions (ADRs). These reports can come from various sources, including healthcare professionals, patients, and pharmaceutical companies. Regulatory authorities play a central role in pharmacovigilance, establishing systems for reporting and evaluating ADRs, and taking appropriate regulatory actions when necessary, such as updating product information, issuing warnings, or even withdrawing a drug from the market.

Pharmacovigilance activities extend beyond simply detecting ADRs. They also encompass risk management plans, which are developed to minimize known or potential risks of a drug. This includes strategies for safe prescribing, dispensing, and patient monitoring. Furthermore, pharmacovigilance contributes to the understanding of the benefit-risk balance of medicines, ensuring that the benefits of a drug continue to outweigh its risks once it is in widespread use. This ongoing evaluation is essential for public health protection.