bivirkningsovervågning

Bivirkningsovervågning, 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 bivirkningsovervågning is to ensure that medicines are safe and effective for public use. This involves collecting and analyzing information about potential side effects that may not have been identified during clinical trials.

Regulatory authorities, such as the European Medicines Agency (EMA) and national drug agencies, play a crucial role in overseeing bivirkningsovervågning. Pharmaceutical companies are also obligated to monitor the safety of their products once they are on the market. Healthcare professionals, such as doctors and pharmacists, are encouraged to report suspected adverse drug reactions. Patients themselves can also report side effects they experience.

The data gathered through bivirkningsovervågning is used to identify new safety concerns, update product information, and in some cases, lead to regulatory actions such as label changes, warnings, or even the withdrawal of a medicine from the market. This continuous monitoring process is essential for protecting public health and maintaining confidence in the safety of medicines. It is a dynamic and ongoing effort that contributes to the overall safe use of pharmaceuticals.