Introduction and evaluation of pharmacovigilance for beginners


  • Pushpraj P. Gawai Senior Drug Safety Officer, MacLeods Pharmaceutical Pvt. Ltd. R and D II, Andheri East, Mumbai, Maharashtra



Pharmacovigilance, Adverse drug reaction, Adverse Event, ICSR


Drugs safety profile monitoring is an essential element for the effective use of medicines and for high quality medical care. Pharmacovigilance (PV), is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The PV comes in picture after elixir sulfanilamide tragedy of 1937 and in the late 1950s and early 1960s, more than 10,000 children in 46 countries were born with deformities such as phocomelia as a consequence of thalidomide use has opened the eyes of drug regulators as well as consumers to establish a way to ensure drug safety. The hospitalization due to adverse drug reaction (ADR) in USA is about or more than 10%. In addition, it is estimates that 15-20% of the hospital inpatient suffers from ADRs. Now the pharmacovigilance system is globalised, strengthen and systematized after the establishment of World Health Organization (WHO) Programme for International Drug Monitoring. The patient safety is now becoming the priority area of pharmaceuticals. In this article, we are describing brief history and introduction of PV that will help to understand PV for beginners.


Metrics Loading ...


Aronson JK. Louis Lewin-Meyler’s predecessor edi 1. Side Effects of Drugs Annual Vol 27, Elsevier. 2004.

Hamburg MA. Innovation, regulation, and the FDA. N Engl J Med. 2010;363(25):2228-32.

Van Grootheest K, Dukes G. Leopold Meyler (1903-1973): a pioneer in the study of adverse effects of drugs. Int J Risk Saf Med. 2003/2004;16:67-70.

The importance of pharmacovigilance-safety monitoring of medicinal products. Geneva: World Health Organization; 2002. Available at: Accessed on 01 July 2020.

Dr V Pannikar. The Return of Thalidomide: New Uses and Renewed Concerns. WHO Pharmaceuticals Newsletter. 2003;2. Available at: https://www.who. int/lep/research/Thalidomide.pdf. Accessed on 01 July 2020.

Pharmacovigilance: Ensuring the Safe Use of Medicines - WHO Policy Perspectives on Medicines, No. 009, October 2004. Available at: Accessed on 01 July 2020.

WHOcc in Uppsala (UMC). Available at: Accessed on 01 July 2020.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalised patients: a meta-analysis of prospective studies. JAMA. 1998;279(15):1200-5.

Institute of Medicine. Preventing medication errors. 2006. Available at: ~/media/Files/Report%20Files/2006/Preventing-Medication-Errors-Quality-Chasm-Series/medicationerrorsnew.pdf . Accessed on 01 July 2020.

Gor AP, Desai SV. Adverse Drug Reactions (ADR) in the in Patients of Medicine Department of a Rural Tertiary Care Teaching Hospital and Influence of Pharmacovigilance in Reporting ADR. Indian J Pharmacol. 2008:40(1):37-40.

The Safety of Medicines in Public Health Programmes: Pharmacovigilance an essential tool. WHO, 2006. Available at: https://www.who. int/medicines/areas/quality_safety/safety_efficacy/Pharmacovigilance_B.pdf?ua=1. Accessed on 01 July 2020.

Douthwaite AH, and Lintott GAM. Gastroscopic observation of the effect of aspirin and certain other substances on the stomach. Lancet. 1938;2:1222-5.

Saskia Middeldorp. Oral contraceptives and the risk of venous thromboembolism. Gender Medicine. 2005,2:S3-S9.

Kefauver-Harris Amendments Revolutionized Drug Development. Available at: consumers/consumer-updates/kefauver-harris-amendments-revolutionized-drug-development. Accessed on 01 July 2020.

G Jeetu and G Anusha. Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring. J Young Pharm. 2010;2(3):315-20.

Routledge P. 150 years of Pharmacovigilance. Lancet. 1998;351(9110):1200-1.

Report E, Effective Communications in PV (1997) International Conference on Developing Effective Communications in Pharmacovigilance, Erice, Sicily. 1997;24-27.

Grady C. Payment of clinical research subjects. J Clin Invest. 2005;115:1681.

Report E. Effective communications in Pharmacovigilance. International Conference on Developing Effective Communications in Pharmacovigilance, Erice, Sicily. 1997;2:24-7.

Talbot J, Aronson JK. Stephens’ Detection and Evaluation of Adverse Drug Reactions, 6th Edition. Pharmacology & Pharmaceutical Medicine, Wiley-Blackwell, 2011:750.

Elisabetta Poluzzi, Emanuel Raschi, Carlo Piccinni and Fabrizio De Ponti (August 29th 2012). Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS), Data Mining Applications in Engineering and Medicine, Adem Karahoca, Intech Open. Available at:

Guideline on good pharmacovigilance practices (GVP) Module VI-Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2). EMA/873138/2011 Rev 2. Available at: https://www.ema.europa. eu/en/documents/regulatory-procedural-guideline/ guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf. Accessed on 01 July 2020.

Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’), Available at: https://eur-lex.europa. eu/LexUriServ/ PDF. Accessed on 01 July 2020.

Code of Federal Regulations, Title 21, Volume 5, Revised as of April 1, 2019, CITE: 21CFR314.80. Accessed on 01 July 2020.

Code of Federal Regulations, Title 21, Volume 5, Revised as of April 1, 2019, CITE: 21CFR312.32.

Pharmacovigilance guidelines for marketing authorization holders of pharmaceutical products in India. Available at: PvPI/pub/Guidance%20Document%20for%20Marketing%20Authorization%20Holders.pdf. Accessed on 01 July 2020.

What Introductory Guide. MedDRA Version 20.1: September 2017. Available at:

Guideline on good pharmacovigilance practices (GVP) Module IX-Signal management, 9 October 2017 EMA/827661/2011 Rev 1. Available at: Accessed on 01 July 2020.

Gliklich RE, Dreyer NA, Leavy MB, Rockville (MD) Registries for Evaluating Patient Outcomes: A User's Guide. 3rd edition. Agency for Healthcare Research and Quality, US; 2014.

U.S. Food and Drug Administration. Guidance for Industry. Good pharmacovigilance practices and pharmacoepidemiologic assessment. 2005. Available at: Information/Guidances/UCM126834.pdf. Accessed on 01 July 2020.

Guideline for post marketing reporting of adverse drug experiences. Available at: https://www.fda. gov/media/83280/download. Accessed on 01 July 2020.






Review Articles