Pharmacovigilance- A drug safety monitoring tool

Research Article

Keywords: Adverse drug reactions, InteInternational Drug Monitoring,, case reporting, signal identification, benefit-risk management

Abstract

The objective of this narrative review is to converse about drug safety, global pharmacological authorities and their responsibility, the process of adverse event reporting, and the main functions of pharmacovigilance. Pharmacovigilance is a science that ensures patient safety against both newly launched and well-established medicinal products in the market. Pharmacovigilance is considered a specific tool used for observing and estimating Adverse Drug Reactions (ADRs) and is essential for successful drug management programs, clinical trials, and public health programs. In the few past years, the number of reported ADRs got increased as a result of which the volume of data got increased. To handle such huge data and the need to understand the pharmacovigilance, it requires highly skilled and proficient people for immediate detection of drug's side effects and protects the product from improper removal. The existing global network of pharmacovigilance centers will be strengthened through an independent review process in coordination with the Uppsala Monitoring Center. Its main role is to assess trials and crucial issues of drug safety that probably influence public health beyond national borders. In this global arena, Pharmacovigilance becomes an important and integral part of clinical research. Most of the countries set up pharmacovigilance centers to monitor drug safety; however, millennial pharmacovigilance faces major challenges for improved safety and drug monitoring.

Author Biography

Shivangi Chauhan, DIPSAR, Delhi Pharmaceutical Sciences and Research University, New Delhi, India

Research Scholar, Department of Pharmacology

References

Avorn J, Solomon DH. Cultural and economic factors that (mis)shape antibiotic use: The nonpharmacologic basis of therapeutics. Annals of Internal Medicine, 2000;133(2):128-35.

Ball LK, Evans G, Bostrom A. Risky business: Challenges in vaccine risk communication. Pediatrics 1998;101(3Pt 1):453-8.

Banerjee AK, Ingate S. Web-based patient-reported outcomes in drug safety and risk management: challenges and opportunities? Drug Safety, 2012;35(6):437–446.

Bapna JS, Tripathi CD, Tekur U. Drug utilization patterns in the third world. Pharmacoeconomics, 1996;9(4):286-94.

Bioclinica. http://www.bioclinica.com/safety-andregulatory-solutions/it-services/arisg-pv-and-clinical-safetysystem; 2017.

CIOMS Form I https://cioms.ch/pharmacovigilance/becoming-the-cioms-member-2/;

Coulter DM. The New Zealand intensive medicines monitoring programme in proactive safety surveillance. Pharmacoepidemiology and Drug Safety, 2000;9(4):273-80.

de Vries CS, Duggan CA, Tromp TF, de Jong-van den Berg LT. Changing prescribing in the light of tolerability concerns: How is this best achieved? Drug Safety, 1999;21(3):153-60.

EMA. Benefit-risk Methodology. https://www.ema.europa.eu/en/about-us/support-research/benefit-risk-methodology, 2021

European Medicines Agency; 2021. Available from: https://www.ema.europa.eu/en/about-us/what-we-do

Geneva: World Health Organization. (‎1973)‎. Handbook of resolutions and decisions of the World Health Assembly and the Executive Board, v. 1: cumulative definitive ed.; v. 2: cumulative definitive ed.; v. 3: 3rd ed. World Health Organization.

Geneva: World Health Organization. Looking at the Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines. Geneva: WHO; 2004.

Hall M, McCormack P, Arthurs N, Feely J. The spontaneous reporting of ADRs by nurses. British Journal of Clinical Pharmacology, 1995;40(2):173-5.

Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systemic review. Drug Safety, 2006;29(5):385–396.

Hornbuckle K, Wu HH, Fung MC. Evaluation of spontaneous adverse event reports by primary reporter: A 15-year review (1983 to 1997). Drug Information Journal 1999;33:1117-24.

Introductory Guide for Standardised MedDRA Queries (SMQs) Version 16.0. https://www.meddra.org/sites/ default/files/guidance/file/smq_intguide_16_0_english.pdf; 2018

Jacob D, Marrón B, Ehrlich J, Rutherford PA. Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients. Drug, Healthcare Patient Safety, 2013;5:105-12.

Jeetu G, Anusha G. Pharmacovigilance: a worldwide master key for drug safety monitoring. Journal of Young Pharmacists, 2010 Jul;2(3):315-20.

Kane A, Lloyd J, Zaffran M, Simonsen L, Kane M. Transmission of hepatitis B, hepatitis C, and human immunodeficiency virus through safe injections in the developing world: mode-based regional estimates. Bulletin of the World Health Organization, 1999;77(10):801-7.

van Grootheest K, Olsson S, Couper M, de Jong-van den Berg L. Pharmacists' role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiology and Drug Safety, 2004;13(7):457-464.

Lazarou J, Pomeranz BH, Corey PN. Incidence of ADRs in hospitalized patients: A meta-analysis of prospective studies. JAMA, 1998;279(15):1200-5.

Mackay FJ. Post-marketing studies: The work of the drug safety research unit. Drug Safety, 1998;19(5):343-53.

MedDRA. https://www.meddra.org/; 2018.

Olsson S. The role of the WHO Programme for International Drug Monitoring in coordinating worldwide drug safety efforts. Drug Safety, 1998;19(1):1-10.

Oracle. http://www.oracle.com/us/products/applications/ health-sciences/safety/argus-safety/index.html; 2017.

Paul Beninger. Pharmacovigilance: An Overview. Clinical Therapeutics, 2018; 40(12):1991-2004.

US Food and Drug Administration; 2021. Available at: https://www.fda.gov/about-fda/what-we-do

Vaccine safety. Vaccine Safety Advisory Committee. Wkly Epidemiol Rec 1999;74:337-40.

Wal P, Mehra R, Rizvi S, Vajpayee R, Pharmacovigilance: need for Indian Pharma industry. International Research Journal of Pharmacy, 2015; 6(11): 740-743.

White TJ, Arakelian A, Rho JP. Counting the costs of drug-related adverse events. Pharmacoeconomics, 1999;15(5):445-58.

WHO Medicines Strategy: Framework for Action in Essential Drugs and Medicines Policy 2000-2003. Available from: http://www.apps.who.int/ medicinedocs/en/d/Jwhozip16e/8.html.

WHO. Pharmacovigilance: Ensuring the Safe Use of Medicines. Geneva, WHO policy perspectives on medicine, October; 2004: 1-5.

Published
2021-09-01
How to Cite
1.
Chauhan S. Pharmacovigilance- A drug safety monitoring tool. jpadr [Internet]. 2021Sep.1 [cited 2021Sep.18];2(3):15-0. Available from: http://jpadr.com/index.php/jpadr/article/view/26