lääkeseuranta

Lääkeseuranta, also known as pharmacovigilance or drug monitoring, refers to the scientific discipline and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It is a crucial part of ensuring the safety of medicines once they have been approved and are in use by the public.

The primary goal of lääkeseuranta is to identify potential risks associated with a medication that may not have been apparent during clinical trials. These trials are conducted under controlled conditions and involve a limited number of participants. Once a drug is prescribed to a broader population with diverse health conditions and lifestyles, unforeseen side effects or interactions can emerge.

Lääkeseuranta involves collecting and analyzing reports of adverse drug reactions (ADRs) from various sources, including healthcare professionals, patients, and pharmaceutical companies. Regulatory authorities, such as the Finnish Medicines Agency (Fimea), play a central role in collecting, evaluating, and disseminating this safety information. They monitor the safety profile of medicines throughout their lifecycle.

Based on the data gathered, regulatory bodies can take appropriate actions to protect public health. These actions might include updating product information, issuing safety warnings, restricting the use of a drug, or, in rare cases, withdrawing a medication from the market. Lääkeseuranta is a continuous process that contributes significantly to the safe and effective use of medicines.