Pharmacovigilance: the evolution of drug safety monitoring.

Abstract

The Pharmacovigilance system is aimed to promote and protect public health by ensuring the availability of essential medicines in the market and reducing the burden of ADRs. Pharmacovigilance is derived from two words; pharamakon rooted in the Greek word that means medicinal substance and vigilia rooted in the Latin word to keep watch. This concept evolved after Hannah Greener died in 1848 after having a tonsillectomy with chloroform. As a result of the Thalidomide tragedy, drug regulation in Europe has forever changed. From its earliest beginnings to its current state, pharmacovigilance has been shaped by several major milestones. The historical phases of pharmacovigilance can help us understand the value of pharmacovigilance and identify the challenges that lie ahead. Despite advancements in technology, it is imperative that we continue to strive for excellence in pharmacovigilance to ensure all individuals' safety and health. Through collaboration between the Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO), and the International Conference on Harmonization (ICH), Pharmacovigilance has evolved into a regulatory activity.