Implementation of a Pharmacovigilance System in a Resources-Limited Country in the Context of COVID-19: Lebanon's Success Story

Ther Innov Regul Sci. 2023 Mar;57(2):178-185. doi: 10.1007/s43441-022-00460-7. Epub 2022 Sep 15.

Abstract

Implementation of Pharmacovigilance (PV) systems in resource-limited countries is a real challenge. The objective of this paper is to describe the implementation of an effective national PV system in Lebanon in the context of COVID-19, within a limited resources setting and with the absence of a guaranteed funding. In 2018, the PV center hosted at the Lebanese University, Faculty of Pharmacy under the supervision of the Quality Assurance of Pharmaceutical Products Program within the Lebanese Ministry of Public Health became an associate member of the World Health Organization (WHO) Program of International Drug Monitoring and recognized as Full member in 2021.This analysis highlights the requirements of the WHO that were met in Lebanon to create an effective PV system. The Lebanese experience shows that it is not only possible, but also crucial to implement a PV system in low to middle-income countries with limited resources and with the absence of a guaranteed funding in order to be able to promote patients' safety. Support from organizations like WHO and World Bank, skilled leadership, hard work and dedicated staff with efficient training, and finally mass awareness initiatives were all considered as key elements to implement a successful PV System. In the midst of a turbulent political, economic and health context, Lebanon has been able to develop one of the most active and rapidly evolving PV systems in the Middle East.

Keywords: Adverse Events; COVID-19; Lebanon; Ministry of Public Health; Pharmacovigilance; Resources limited country.

Publication types

  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • COVID-19*
  • Drug Monitoring
  • Humans
  • Lebanon
  • Pharmacovigilance*