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

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 gua...

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Autores principales: Abbas, Hanine, Zeitoun, Abeer, Watfa, Myriam, Karam, Rita
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9483279/
https://www.ncbi.nlm.nih.gov/pubmed/36109433
http://dx.doi.org/10.1007/s43441-022-00460-7
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author Abbas, Hanine
Zeitoun, Abeer
Watfa, Myriam
Karam, Rita
author_facet Abbas, Hanine
Zeitoun, Abeer
Watfa, Myriam
Karam, Rita
author_sort Abbas, Hanine
collection PubMed
description 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.
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spelling pubmed-94832792022-09-19 Implementation of a Pharmacovigilance System in a Resources-Limited Country in the Context of COVID-19: Lebanon’s Success Story Abbas, Hanine Zeitoun, Abeer Watfa, Myriam Karam, Rita Ther Innov Regul Sci Review 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. Springer International Publishing 2022-09-15 2023 /pmc/articles/PMC9483279/ /pubmed/36109433 http://dx.doi.org/10.1007/s43441-022-00460-7 Text en © The Author(s), under exclusive licence to The Drug Information Association, Inc 2022, Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Review
Abbas, Hanine
Zeitoun, Abeer
Watfa, Myriam
Karam, Rita
Implementation of a Pharmacovigilance System in a Resources-Limited Country in the Context of COVID-19: Lebanon’s Success Story
title Implementation of a Pharmacovigilance System in a Resources-Limited Country in the Context of COVID-19: Lebanon’s Success Story
title_full Implementation of a Pharmacovigilance System in a Resources-Limited Country in the Context of COVID-19: Lebanon’s Success Story
title_fullStr Implementation of a Pharmacovigilance System in a Resources-Limited Country in the Context of COVID-19: Lebanon’s Success Story
title_full_unstemmed Implementation of a Pharmacovigilance System in a Resources-Limited Country in the Context of COVID-19: Lebanon’s Success Story
title_short Implementation of a Pharmacovigilance System in a Resources-Limited Country in the Context of COVID-19: Lebanon’s Success Story
title_sort implementation of a pharmacovigilance system in a resources-limited country in the context of covid-19: lebanon’s success story
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9483279/
https://www.ncbi.nlm.nih.gov/pubmed/36109433
http://dx.doi.org/10.1007/s43441-022-00460-7
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