Chapter 15 - Pharmacovigilance Systems

Abstract

Pharmacovigilance is an essential part of healthcare systems worldwide. Most countries operate national pharmacovigilance systems as part of their public health and healthcare policies. The World Health Organization international drug monitoring program through the Uppsala Monitoring Center (UMC) aims to facilitate the collaboration of national pharmacovigilance systems. The objective of pharmacovigilance is safe use of drugs, patient safety, and, ultimately, safeguarding public health. To achieve this goal, national regulators and international organizations rely on the reporting of adverse drug reactions (ADRs). National, regional, and global data on ADRs inform regulators, healthcare professionals, and the public about safety concerns with pharmaceutical products. However, the number of reported ADRs is far below the number of ADRs that actually occur. Hence, statistics available through the UMC only show data on ADRs reported but not all actual events. The phenomenon of underreporting of ADRs is widespread and common to all national pharmacovigilance systems. Hence, to achieve the goal of patient safety and public health, regulators at all levels should work actively to increase ADR reporting by healthcare professionals and the public.