Ravimiohutusjärelevalve

Ravimiohutusjärelevalve, 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. Its primary goal is to ensure the safe use of medicines by identifying and evaluating potential risks once a drug has been approved and is on the market. This process is crucial as rare or long-term side effects may not be apparent during clinical trials, which involve a limited number of participants.

The process involves collecting and analyzing reports of suspected adverse drug reactions from various sources, including healthcare professionals, patients, and pharmaceutical companies. These reports are then assessed by regulatory authorities, such as the Estonian Agency of Medicines, to determine if there is a causal link between the medicine and the reported event. If a safety concern is identified, regulatory bodies can take appropriate actions. These actions might include updating the product information with new warnings or contraindications, restricting the use of the medicine, or in severe cases, withdrawing it from the market.

Ravimiohutusjärelevalve is an ongoing process that continues throughout the entire lifecycle of a medicine, from development to post-marketing surveillance. It plays a vital role in protecting public health by ensuring that the benefits of medicines continue to outweigh their risks. Patients and healthcare providers are encouraged to report any suspected side effects, as this information is essential for maintaining the safety of pharmaceutical products.