lääketurvatoiminta

Lääketurvatoiminta, also known as pharmacovigilance, is 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 ensure the safe and effective use of medicines by identifying and mitigating potential risks associated with their use. This process involves collecting, reporting, and analyzing information about suspected side effects from healthcare professionals, patients, and pharmaceutical companies.

The history of pharmacovigilance can be traced back to the early 20th century, with significant advancements made following major drug safety incidents. Regulatory bodies worldwide, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), play a crucial role in overseeing pharmacovigilance activities. They establish guidelines, review safety data, and take regulatory actions when necessary to protect public health.

Key activities within pharmacovigilance include spontaneous reporting systems, where healthcare professionals and patients can report suspected adverse drug reactions. These reports are then collected and analyzed to identify potential safety signals. Signal detection is a critical component, involving statistical methods and expert review to identify potential new risks or changes in the frequency of known risks. Risk management plans are developed to outline strategies for minimizing identified risks.

Pharmacovigilance is an ongoing process that continues throughout the entire lifecycle of a medicine, from its development and clinical trials to post-marketing surveillance. It is essential for maintaining public trust in medicines and ensuring that the benefits of using a medication outweigh its risks.