CHARTING THE COURSE: AN OVERVIEW OF PHARMACOVIGILANCE HISTORY

Lalit Sharma; Nancy Vaid; Himanshu; Tanuj; Mohit

doi:10.53555/jptcp.v31i6.6439

Lalit Sharma
Nancy Vaid
Himanshu
Tanuj
Mohit

Keywords

Thalidomide disaster, Regulatory agencies, Post-marketing surveillance, Adverse Drug Reactions (ADRs)

Abstract

Pharmacovigilance is a critical component of healthcare systems worldwide, focusing on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. This abstract provides a concise overview of pharmacovigilance, its significance, objectives, and key processes. It highlights the role of pharmacovigilance in ensuring the safety and efficacy of pharmaceutical products and its evolving importance in the context of public health. It also emphasises the international collaboration and legal framework that oversee pharmacovigilance efforts, highlighting the ongoing requirement for thorough medication safety monitoring to safeguard patient welfare.

Abstract 204 | pdf Downloads 120

References

1. Pharmacovigilance Risk Assessment Committee: PRAC strategy on measuring the impact of Pharmacovigilance activities. 2016. International Journal of Clinical Pharmacy1 3 http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/01/WC500199756.pdf.
2. Onakpoya IJ, Heneghan CJ, Aronson JK. Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review. Expert Opin Drug Saf. 2018;17:63–72.
3. Routledge P. 150 years of pharmacovigilance. Lancet. 1998;351:1200–1.
4. Commission on Anaesthetics. Lancet. 1893; i:629–38.
5. Woolf AD. The Haitian diethylene glycol poisoning tragedy: a dark wood revisited. JAMA. 1998;279:1215–6.
6. FDA Consumer Magzine. https ://www.fda.gov/downl oads/AboutFDA/WhatWeDo/History/Origin/ucm125604.doc (1981). Accessed 22 Dec 2017.
7. Food and Drug Administration (FDA). History. https://www.fda. gov/AboutFDA/WhatWeDo/Histor/. Accessed 22 Dec 2017.
8. Douthwaite AH. Some recent advances in medical diagnosis and treatment. Br Med J. 1938;1:1143.
9. Levy M. The epidemiological evaluation of major upper gastrointestinal bleeding in relation to aspirin use. In: Kewitz H, Roots I, Voigt K, editors. Epidemiological concepts in clinical pharmacology. Berlin: Springer; 1987. p. 100–4.
10. Kim JH, Scialli AR. Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicol Sci. 2011 Jul;122(1):1-6. doi: 10.1093/toxsci/kfr088. Epub 2011 Apr 19. Erratum in: Toxicol Sci. 2012 Feb;125(2):613. PMID: 21507989..
11. Lenz W, Knapp K. Foetal malformations due to Thalidomide. German Med. 1962;7:253–8.
12. Kajii T, Kida M, Takahashi K. The effect of thalidomide intake during 113 human pregnancies. Teratology. 1973;8:163–6.
13. ICH guideline. https://www.ich.org/fileadmin/Public_Web_Site/ ICH_Products/Guidelines/Efficacy/E2D/Step4/E2D_Guideline. pdf. Accessed 22 Dec 2017.
14. Yellowcard. https://yellowcard.mhra.gov.uk/monitoringsafety/. Accessed 22 Dec 2017.
15. Council Directive 65/65/EEC. http://www.echamp.eu/eu-legislatio n-and-regulation-documents/directive_65-65-eec__-__consolidated_version.pdf. Accessed 22 Dec 2017.
16. Boston Collaborative Drug Surveillance Program. http://www.bu.edu/bcd sp/. Accessed 22 Dec 2017
17. .17. WHO Pharmacovigilance. http://www.who.int/medicines/areas /quality_safety/safety_efficacy/pharmvigi/en/. Accessed 22 Dec 2017.
18. ISoP - ESOP/ISoP History. http://isoponline.org/about-isop/esopi sop-history/. Accessed 22 Dec 2017.
19. EMA History. http://www.ema.europ a.eu/ema/index .jsp?curl=pages/about_us/general/general_content_000628.jsp. Accessed 22 Dec 2017.
20. EudraVigilance history. http://www.ema.europ a.eu/ema/index .jsp?curl=pages/regulation/general/general_content_000633.jsp. Accessed 22 Dec 2017.
21. Directive 2010/84/EU. https ://ec.europ a.eu/healt h/sites /healt h/files /files /eudra lex/vol-1/dir_2010_84/dir_2010_84_en.pdf. Accessed 22 Dec 2017.
22. EMA Pharmacovigilance. http://www.ema.europa.eu/ema/index .jsp?curl=pages /regul ation /gener al/gener al_conte nt_00181 9.jsp&mid=WC0b01ac05800241de. Accessed 14 Mar 2018.
23. Lihite, Ratan J, and Mangala Lahkar. “An update on the Pharmacovigilance Programme of India.” Frontiers in pharmacology vol. 6 194. 22 Sep. 2015, doi:10.3389/fphar.2015.00194
24. Kalaiselvan V, Srivastava S, Singh A, Gupta SK. Pharmacovigilance in India: Present Scenario and Future Challenges. Drug Saf. 2019 Mar;42(3):339-346. doi: 10.1007/s40264-018-0730-7. PMID: 30269244.
25. Suke, Sanvidhan G et al. “Role of Pharmacovigilance in India: An overview.” Online journal of public health informatics vol. 7,2 e223. 1 Jul. 2015, doi:10.5210/ojphi.v7i2.5595

pdf

Published

Jun 1, 2024

DOI: https://doi.org/10.53555/jptcp.v31i6.6439

How to Cite

CHARTING THE COURSE: AN OVERVIEW OF PHARMACOVIGILANCE HISTORY. (2024). Journal of Population Therapeutics and Clinical Pharmacology, 31(6), 38-47. https://doi.org/10.53555/jptcp.v31i6.6439

Issue

Vol. 31 No. 6 (2024): JPTCP

Section

Articles

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.

Author Biographies