Pharmacovigilance- A drug safety monitoring tool
Abstract
Introduction: 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.
Objectives: 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.
Methods: 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.
Results: 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.
Conclusions: Most of the countries set up pharmacovigilance centers to monitor drug safety; however, millennial pharmacovigilance faces major challenges for improved safety and drug monitoring.
Downloads
References
Avorn, J., & Solomon, D. H. (2000). Cultural and economic factors that (mis)shape antibiotic use: the nonpharmacologic basis of therapeutics. Annals of internal medicine, 133(2), 128–135.
Ball, L. K., Evans, G., & Bostrom, A. (1998). Risky business: challenges in vaccine risk communication. Pediatrics, 101(3 Pt 1), 453–458.
Banerjee, A. K., & Ingate, S. (2012). Web-based patient-reported outcomes in drug safety and risk management: challenges and opportunities? Drug safety, 35(6), 437–446.
Bapna, J. S., Tripathi, C. D., & Tekur, U. (1996). Drug utilisation patterns in the Third World. PharmacoEconomics, 9(4), 286–294.
Beninger P. (2018). Pharmacovigilance: An Overview. Clinical therapeutics, 40(12), 1991–2004.
Bioclinica.(2017). Retireved from: http://www.bioclinica.com/safety- andregulatory-solutions/it-services/arisg-pv-and- clinical-safetysystem.
CIOMS Form I Retrieved from : https://cioms.ch/pharmacovigilance/becoming-the-cioms-member-2/
Coulter D. M. (2000). The New Zealand intensive medicines monitoring programme in pro-active safety surveillance. Pharmacoepidemiology and drug safety, 9(4), 273–280.
de Vries, C. S., Duggan, C. A., Tromp, T. F., & de Jong-van den Berg, L. T. (1999). Changing prescribing in the light of tolerability concerns: how is this best achieved?. Drug safety, 21(3), 153–160.
EMA. (2021). Benefit-risk Methodology. Retrieved from: https://www.ema.europa.eu/en/about-us/support-research/benefit-risk-methodology, 2021
European Medicines Agency. (2021). Retrieved 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. (2004). Looking at the Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines. Geneva: WHO.
Hall, M., McCormack, P., Arthurs, N., & Feely, J. (1995). The spontaneous reporting of adverse drug reactions by nurses. British journal of clinical pharmacology, 40(2), 173–175.
Hazell, L., & Shakir, S. A. (2006). Under-reporting of adverse drug reactions: a systematic review. Drug safety, 29(5), 385–396.
Hornbuckle, K., Wu, H. H., Fung, M. C. (1999). Evaluation of spontaneous adverse event reports by primary reporter: A 15-year review (1983 to 1997). Drug information journal, 33:1117-24.
Introductory Guide for Standardised MedDRA Queries (SMQs) (2018). Version 16.0. Retrieved from :https://www.meddra.org/sites/ default/files/guidance/file/smq_intguide_16_0_english.pdf
Jacob, D., Marron, B., Ehrlich, J., & Rutherford, P. A. (2013). 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 and patient safety, 5, 105–112.
Jeetu, G., & Anusha, G. (2010). Pharmacovigilance: a worldwide master key for drug safety monitoring. Journal of young pharmacists : JYP, 2(3), 315–320.
Kane, A., Lloyd, J., Zaffran, M., Simonsen, L., & Kane, M. (1999). Transmission of hepatitis B, hepatitis C and human immunodeficiency viruses through unsafe injections in the developing world: model-based regional estimates. Bulletin of the World Health Organization, 77(10), 801–807.
Lazarou, J., Pomeranz, B. H., & Corey, P. N. (1998). Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA, 279(15), 1200–1205.
Mackay F. J. (1998). Post-marketing studies: the work of the Drug Safety Research Unit. Drug safety, 19(5), 343–353.
MedDRA. https://www.meddra.org/; 2018.
Olsson S. (1998). The role of the WHO programme on International Drug Monitoring in coordinating worldwide drug safety efforts. Drug safety, 19(1), 1–10.
Oracle. (2017). Retrieved from: http://www.oracle.com/us/products/applications/ health-sciences/safety/argus-safety/index.html; 2017.
US Food and Drug Administration. (2021). Retrieved from: https://www.fda.gov/about-fda/what-we-do
Vaccine safety. Vaccine Safety Advisory Committee. (1999). Releve epidemiologique hebdomadaire, 74(41), 337–340.
van Grootheest, K., Olsson, S., Couper, M., & de Jong-van den Berg, L. (2004). Pharmacists' role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiology and drug safety, 13(7), 457–464.
Wal, P., Mehra, R., Rizvi, S., Vajpayee, R. (2015). Pharmacovigilance: need for Indian Pharma industry. International research journal of pharmacy, 6(11), 740-743.
White, T. J., Arakelian, A., & Rho, J. P. (1999). Counting the costs of drug-related adverse events. PharmacoEconomics, 15(5), 445–458.
WHO Medicines Strategy: Framework for Action in Essential Drugs and Medicines Policy 2000-2003. Retrieved from from: http://www.apps.who.int/ medicinedocs/en/d/Jwhozip16e/8.html.
WHO. (2004) Pharmacovigilance: Ensuring the Safe Use of Medicines. Geneva, WHO policy perspectives on medicine, October, 1-5.

Copyright (c) 2021 Shivangi Chauhan

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