farmakovigilanssystemer

Pharmako-vigilance is the practice of monitoring the safety of medicinal products after they have been approved for marketing. It involves the systematic collection, analysis, and interpretation of data on the adverse reactions and other safety issues associated with a particular drug or group of drugs.

The main objective of pharmaco-vigilance is to identify and assess the potential risks associated with a medicinal product in order to prevent harm to patients and to improve the quality of healthcare. This is achieved through the collection of data from a variety of sources, including reports from healthcare professionals, patients, and the general public.

Pharmaco-vigilance programs are typically managed by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States, and by pharmaceutical companies. These programs use a variety of methods to collect data, including spontaneous adverse event reporting, literature reviews, and epidemiological studies.

The data collected through pharmaco-vigilance is analyzed and interpreted by experts in pharmacology and epidemiology. The results of this analysis are used to update the labelling and packaging of the medicinal product, to change its prescribing instructions, and in some cases, to withdraw the drug from the market.

Pharmaco-vigilance is an essential component of the post-marketing surveillance of medicinal products. It helps to ensure that the benefits of a drug outweigh its risks and contributes to the development of safe and effective medicines.