Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2024 Oct 23;17(1):2417399.
doi: 10.1080/20523211.2024.2417399. eCollection 2024.

Pharmacovigilance: the evolution of drug safety monitoring

Affiliations
Editorial

Pharmacovigilance: the evolution of drug safety monitoring

Muhammad Akhtar Abbas Khan et al. J Pharm Policy Pract. .

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.

PubMed Disclaimer

Conflict of interest statement

No potential conflict of interest was reported by the author(s).

Figures

Figure 1.
Figure 1.
Historical overview of Pharmacovigilance.

Similar articles

Cited by

References

    1. 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
    1. Banovac, M., Candore, G., Slattery, J., Houÿez, F., Haerry, D., Genov, G., & Arlett, P. (2017). Patient reporting in the EU: Analysis of EudraVigilance data. Drug Safety, 40(7), 629–645. 10.1007/s40264-017-0534-1 - DOI - PubMed
    1. Beninger, P., & Ibara, M. A. (2016). Pharmacovigilance and Biomedical Informatics: A Model for Future Development. Clinical Therapeutics, 38(12), 2514–2525. 10.1016/j.clinthera.2016.11.006 - DOI - PubMed
    1. 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
    1. 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.

Publication types

LinkOut - more resources