pharmacovigilancevaatimuksia

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. It is a crucial component of drug safety and public health, ensuring that medicines are used safely and effectively throughout their lifecycle. The primary goal of pharmacovigilance is to identify potential risks associated with a medicine that may not have been apparent during clinical trials, which are typically conducted on a limited number of participants over a short period.

This process involves collecting and analyzing reports of adverse events from various sources, including healthcare professionals, patients, and pharmaceutical companies. These reports provide valuable real-world data on how a drug performs in the general population. Regulatory agencies worldwide, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe, play a key role in overseeing pharmacovigilance activities.

When a potential safety issue is identified, pharmacovigilance systems can trigger regulatory actions. These actions might include updating product labeling with new warnings or precautions, issuing safety alerts, restricting the use of a drug, or even withdrawing it from the market if the risks are deemed unacceptable. Effective pharmacovigilance contributes significantly to safeguarding patient health and maintaining public trust in medicines.