lääkkeidenvalvonta

Lääkkeidenvalvonta is a Finnish term that translates to "drug surveillance" or "medicine monitoring." It refers to the systematic collection, analysis, and interpretation of information on the use of medicines and their effects in the population. This process is crucial for ensuring the safety and effectiveness of pharmaceutical products after they have been approved and marketed.

The primary goal of lääkkeidenvalvonta is to detect and assess any potential adverse drug reactions (ADRs) that may not have been identified during clinical trials. Clinical trials are typically conducted on a limited number of participants and for a finite duration, which may not reveal rare or long-term side effects. Post-marketing surveillance, or pharmacovigilance, allows for the monitoring of a much larger and more diverse patient population, providing real-world data on drug safety.

In Finland, lääkkeidenvalvonta is primarily the responsibility of the Finnish Medicines Agency (Fimea). Healthcare professionals, such as doctors and pharmacists, are obligated to report suspected adverse reactions to Fimea. Patients and consumers can also report adverse drug reactions directly to Fimea or through their healthcare providers.

The information gathered through lääkkeidenvalvonta is used to update product information, issue safety warnings, and, in some cases, lead to regulatory actions such as restricting the use of a medicine or even withdrawing it from the market. This continuous monitoring process plays a vital role in protecting public health and maintaining confidence in the safety of medicines. It is an ongoing effort that contributes to the responsible use of pharmaceuticals.