Pharmacovigilance
What is Pharmacovigilance?
Pharmacovigilance, according to the World Health Organization, is the science and set of activities related to the detection, assessment, understanding, and prevention of adverse effects associated with medicines.
What is the goal of Pharmacovigilance?
Its primary goal is to safeguard Public Health and maintain a positive benefit–risk balance for every medicinal product, both during clinical trials and after it has been placed on the market. Specifically, it ensures that medicinal products continue to deliver benefits while mitigating potential risks. Moreover, it ensures timely information on the safety of the medicinal products to patients and healthcare professionals.
Why is Pharmacovigilance important?
The reporting of adverse events (AEs) is essential and can be carried out by healthcare professionals and consumers either to the Marketing Authorization Holder (MAH) or to the National Organization for Medicines through the “Yellow Card” system. Not only serious or unexpected reactions should be reported, but also mild or frequent events, as well as special situations such as medication errors, overdose, off-label use, or exposure during pregnancy.
Continuous collection and evaluation of safety data enable the identification of safety signals and, when necessary, the implementation of appropriate measures. These may include updates to product information, interventions, additional safety studies, or even suspension or withdrawal of a marketing authorization. Failure to report adverse events leads to loss of valuable safety information and may negatively impact patient safety and the sustainability of the healthcare system.
Active participation by all stakeholders enhances knowledge about medicines and contributes to safer and more effective therapeutic practice.
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