A Review on Importance of Pharmacovigilance
DOI:
https://doi.org/10.32628/IJSRST52411254Keywords:
Adverse Drug Reactions, Pharmacovigilance, Spontaneous Reporting System, Uppsala Monitoring Centre, Causality Assessment System, ADR AssessmentAbstract
In the labyrinth of healthcare, Pharmacovigilance (PV) serves as the beacon of safety, navigating through the intricate web of drug interactions and effects on human health. As pharmaceutical and biotechnological marvels strive to diagnose, prevent, or cure diseases, the significance of PV cannot be overstated, especially in a country as populous as India, where over a billion individuals stand as potential recipients of medicinal interventions. Despite India's involvement in the Uppsala Monitoring Center (UMC) program, its contribution to the global PV database remains modest, underscoring the need for a more robust and participatory approach. Signal assessment, utilizing tools such as the World Health Organization (WHO) scale and the Naranjo scale, emerges as a crucial yet intricate process in discerning causality amidst the complex tapestry of drug effects.This article embarks on a systematic exploration of PV in India, tracing its journey from inception to the contemporary landscape. It delves into various strategies and propositions aimed at fortifying the PV framework and enhancing the culture of adverse drug reaction (ADR) reporting nationwide.In the realm of PV, the paramount concern lies in the under-reporting of ADRs, a challenge exacerbated by the escalating instances of patient hospitalization due to adverse drug effects. Unraveling the intricacies of causation becomes a formidable task, particularly in scenarios where patients are subjected to a confluence of multiple medications simultaneously. This review ventures into the diverse arsenal of assessment scales employed in ADR evaluation, each offering a unique vantage point in the quest to identify causative agents. From the intricate dance of pharmacokinetics to the subtle nuances of drug interactions, every facet of PV is scrutinized with meticulous attention, echoing the imperative of safeguarding patient well-being in every therapeutic endeavor. As India treads the path of PV, it stands at the threshold of discovery and innovation, poised to unravel the mysteries of drug safety with diligence and resolve. With each stride forward, the nation inches closer to a future where the promise of pharmaceutical advancements is matched only by the assurance of patient safety.
Downloads
References
WHO. The Importance of Pharmacovigilance: Safety Monitoring of medicinal products. 2002;
Singh KNM and Kanase HR. Pharmacovigilance Programme of India: The Beginning, Current Status and Recent Progress. Adv Pharmacoepidemiol Drug Saf. 2017;6(4):1-4. Doi: 10.4172/2167- 1052.1000219
Pharmacovigilance. World Health Organization. 2017;
Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian J Pharmacol. 2016;48(6):624-628. Doi: 10.4103/0253-7613.194855
PvPI Reaches out to rural masses. Newsletter Pharmacovigilance Programme of India. 2017;
Pharmacovigilance & Risk Management Strategies Forum. 5th Annual Flemming Conference, Philadelphia, PA. 2018;
Kenneth FS and David AG. Case-control studies: research in reverse. Lancet. 2002;359(9304):431-434. Doi: 10.1016/S0140- 6736(02)07605-5
Honig PK. Advancing the science of pharmacovigilance. Clin Pharmacol Ther. 2013;93(6):474-475. Doi: 10.1038/clpt.2013.60
Williams D and Feely J. Underreporting of adverse drug reactions: attitudes of Irish doctors. Ir J Med Sci. 1999;168(4):257-261.
McBride WG. Thalidomide and congenital abnormalities. Lancet. 1961;278(7216):1358.
Olsson S. The role of the WHO Programme for International Drug Monitoring in coordinating worldwide drug safety efforts. Drug Saf. 1998;19(1):1-10.
Edwards IR. The accelerating need for pharmacovigilance. J R Colle Physicians Lond. 2000;34(1):48-51.
Moore N. The role of the clinical pharmacologist in the management of ADRs. Drug Safety. 2001;24(1):1-7.
Kulkarni RD. Reporting system for rare side effects of non-narcotic analgesics in India: Problems and opportunities. Medical Toxicology. 1986;1:110-113.
Gandhi TK, Weingart SN, Borus J, Seger AC, Josh Peterson, Elisabeth Burdick, et al. Adverse drug events in ambulatory care. N Engl J Med. 2003;348:1556-1564. Doi: 10.1056/NEJMsa020703
World Health Organization (WHO). Uppsala Monitoring Centre: The use of the WHO-UMC system for standardized case causality assessment. 2005;
Chyka PA and McCommon SW. Reporting of ADRs by poison control centres in the US. Drug Saf. 2000;23(1):87-93.
Dal Pan GJ. Ongoing challenges in pharmacovigilance. Drug Saf. 2014;37(1):1-8. Doi: 10.1007/s40264-013-0123-x
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA. 1998;279915):1200-1205.
Folb PI and Olliaro P. Pharmaceutical policies and regulatory control. WHO Drug Information. 2000;14(2):82-84.
Evans SJ. Pharmacovigilance: a science or fielding emergencies?. Stat Med. 2000;19(23):3199-3209.
Wieniawski W. International harmonization of regulatory activities: future options. WHO Drug Information. 2000;14(3):145-159.
Pipasha B, Biswas AK. Setting standards for proactive pharmacovigilance in India: The way forward. Indian J Pharmacol 2007;39(3):124-8.
WHO. Pharmacovigilance: Ensuring the Safe Use of Medicines. Geneva: WHO; 2004.
WHO. Policy Perspectives on Medicines. Geneva: WHO; 2004.
Skalli S, Soulaymani Bencheikh R. Safety monitoring of herb-drug interactions: A component of pharmacovigilance. Drug Saf 2012;35(10):785-91.
Arnott J, Hesselgreaves H, Nunn AJ, Peak M, Pirmohamed M, Smyth RL, et al. What can we learn from parents about enhancing participation in pharmacovigilance? Br J Clin Pharmacol 2013;75(4):1109-17.
Gerritsen R, Faddegon H, Dijkers F, van Grootheest K, van Puijenbroek E. Effectiveness of pharmacovigilance training of general practitioners: A retrospective cohort study in the Netherlands comparing two methods. Drug Saf 2011;34(9):755-62.
Kshirsagar N, Ferner R, Figueroa BA, Ghalib H, Lazdin J. Pharmacovigilance methods in public health programmes: The example of miltefosine and visceral leishmaniasis. Trans R Soc Trop Med Hyg 2011;105(2):61-7.
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998;279(15):1200-5.
Danan G, Benichou C. Causality assessment of adverse reactions to drugs--I. A novel method based on the conclusions of international consensus meetings: Application to drug-induced liver injuries. J Clin Epidemiol 1993;46(11):1323-30.
Agbabiaka TB, Savovic J, Ernst E. Methods for causality assessment of adverse drug reactions: A systematic review. Drug Saf 2008;31(1):21-37.
Macedo AF, Marques FB, Ribeiro CF, Texeira F. Causality assessment of adverse drug reactions: Comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel. Pharmacoepidemiol Drug Saf 2005;14(12):885-90.
Dangoumau J, Evreux JC, Jouglard J. Mehtod for determination of undesirable effects of drugs. Therapie 1978;33(3):373-81.
Kramer MS, Leventhal JM, Hutchinson TA, Feinstein AR. An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use. JAMA 1979;242(7):623-32.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30(2):239-45.
Lagier G, Vincens M, Castot A. Imputability in drug monitoring. Principles of the balanced drug reaction assessment method and principal errors to avoid. Therapie 1983;38(3):303-18.
Venulet J, Ciucci A, Berneker GC. Standardized assessment of drug-adverse reaction associations – Rationale and experience. Int J Clin Pharmacol Ther Toxicol 1980;18(9):381-8.
Loupi E, Ponchon AC, Ventre JJ, Evreux JC. Imputability of a teratogenic effect. Therapie 1986;41(3):207-10.
Mashford ML. The Australian method of drug-event assessment. Special workshop – regulatory. Drug Inf J 1984;18(3-4):271-3.
Hutchinson TA. Computerized Bayesian ADE assessment. Drug Inf J 1991;25:235-41.
Hutchinson TA, Dawid AP, Spiegelhalter DJ, Cowell RG, Roden S. Computerized aids for probabilistic assessment of drug safety: I. A spreadsheet program. Drug Inf J 1991;25:29-39.
World Health Organization (WHO), Uppsala Monitoring Centre. The use of the WHO-UMC System for Standardized Case Causality Assessment. Available from: http://www.who-umc.org/graphics/4409.pdf.
Downloads
Published
Issue
Section
License
Copyright (c) 2024 International Journal of Scientific Research in Science and Technology
This work is licensed under a Creative Commons Attribution 4.0 International License.
How to Cite
