Pharmacovigilance: the evolution of drug safety monitoring
- PMID: 39450127
- PMCID: PMC11500540
- DOI: 10.1080/20523211.2024.2417399
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.
Keywords: Adverse drug reactions; drug safety; medicines safety; monitoring; pharmacovigilance; public health.
© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
Conflict of interest statement
No potential conflict of interest was reported by the author(s).
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References
-
- Bahri, P., & Arlett, P. (2014). Regulatory pharmacovigilance in the European Union. In Andrews E. B. & Moore N. (Eds.), Mann’s pharmacovigilance (pp. 171–184). Wiley. 10.1002/9781118820186.ch13a - DOI
-
- Cui, X., Wang, L.-X., Liu, G.-Y., & Xie, Y.-M. (2021). Enlightenment of international pharmacovigilance system on establishment of pharmacovigilance system of Chinese medicine. Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica, 46(21), 5450–5455. 10.19540/j.cnki.cjcmm.20210918.501 - DOI - PubMed
-
- EU . (2008). European Commission. MEMO/08/782: Strengthening pharmacovigilance to reduce adverse effects of medicines. https://ec.europa.eu/commission/presscorner/detail/en/memo_08_782.
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