lääkkeenseurantaa

Lääkkeenseurantaa is the Finnish term for pharmacovigilance, which refers to the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. The primary goal of pharmacovigilance is to improve patient safety in relation to the use of medicines. This involves monitoring the safety of medicines throughout their entire lifecycle, from development and clinical trials to post-marketing surveillance.

In Finland, the responsibility for pharmacovigilance lies with the Finnish Medicines Agency (Fimea). Healthcare professionals, patients, and pharmaceutical companies are encouraged to report suspected adverse drug reactions to Fimea. These reports are collected, analyzed, and used to identify potential safety issues that may not have been apparent during clinical trials. If a significant safety concern is identified, Fimea can take regulatory action, such as updating product information, issuing safety warnings, or even withdrawing a medicine from the market.

Pharmacovigilance activities are crucial for ensuring that the benefits of a medicine continue to outweigh its risks once it is available to the general public. It is a continuous process that adapts to new information and evolving understanding of how medicines affect different individuals and populations. This ongoing monitoring helps to maintain public trust in the safety of pharmaceutical products and contributes to better health outcomes.