PHARMACOVIGILANCE: A REVIEW ARTICLE


Dr. Jayesh K.m. Rajgopal, Dr. Kajal Shilpi, Arun Kumar Srivastav

Abstract


Pharmacovigilance (Pv) is an important tool for the safety and ensuring that the patients are safe in every aspect of the drugs being taken in any form. India as a growing part in pharmacovigilance and their activities is still in its nascent stage, there is a lot to be done in the field of Pharmacovigilance, in ensuring that the safe implementation of the activities. There is still a major part that goes underreporting in India. It has been reported that the number of patients dying because of contrary effects of drugs per year increased upto 2.6-fold. Moreover, rates of hospitalization of patients are increasing owing to adverse effects of drugs, and it becomes a challenge to find out the exact drugs causing the ADR’s when a patient in treated with multiple drugs simultaneously. In the review we will explore the different types of assessment scale to do the ADR assessment and to find its causative agents.

Key Words- Pharmacovigilance, Adverse Drug Reactions.


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References


Pipasha B, Arun KB. Setting standards for proactive pharmacovigilance in India: The way forward, Indian J Pharmacol, 39(3), 2007, 124-128.

WHO, Pharmacovigilance: ensuring the safe use of medicines, Geneva: WHO 2004.

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

Skalli S, Soulaymani Bencheikh R. Safety monitoring of herb-drug interactions: acomponent of pharmacovigilance. Drug Saf 2012;35:785-91.

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 2012; in press.

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;34:755-62.

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;105:61-7.

The importance of pharmacovigilance. Geneva: World Health Organization; 2002.

Lazarou J, Pomeranz B, Corey P. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998; 279:1200-5.

Pharmacovigilance. Mann RD, Andrews EB, eds. John Wiley & Sons Ltd, Chichester, 2002.

The Importance of Pharmacovigilance, WHO 2002.

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 druginduced liver injuries. J clin epidemiol., 1993; 46(1): 132-142.

Taofikat BA, Savovi J, Ernst E; Methods for Causality Assessment of Adverse Drug Reactions A Systematic Review. Drug Safety, 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: 885-890.

Dangoumau J, Evreux JC, Jouglard J; Methodfor determination of undesirable effects of drugs [in French]. Therapie, 1978; 33: 373-381.

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: 623-632.

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA et al.; A method for estimating the probability of adverse drugreactions. Clin Pharmacol Ther., 1981; 30:239-245.

Lagier G, Vincens M, Castot A; Imputability in drug monitoring: principles of the balanced drug reaction assessment method and principalerrors to avoid. Therapie, 1983; 38: 303-318.

Venulet J, Ciucci A, Berneker GC; Standardised assessment of drug-adverse reaction associations: rationale and experience.Int J Clin Pharmacol Ther Toxicol., 1980; 18:381-388.

Loupi E, Ponchon AC, Ventre JJ; Imputability of a teratogenic effect [in French]. Therapie,1986; 41: 207-210.

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 druginduced liver injuries. J clin epidemiol., 1993; 46(1): 132-142.

Mashford ML; The Australian method of drugevent assess ment. Special Workshop – regulatory. Drug Inf J., 1984; 18: 271-273.

Hutchinson TA; Computerized Bayesian ADE assessment. Drug Inf J., 1991; 25: 235-241.

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 [Internet]. The use of the WHO-UMC system for standardized case causality assessment. Available from: http://www.who-umc.org/graphics/4409.pdf.

Rehan HS, Chopra D, Kakkar A; Physician's guide to pharmacovigilance: Terminology and causality assessment. European Journal of Internal Medicine, 2009; 20: 3-8.




About this article

Title

PHARMACOVIGILANCE: A REVIEW ARTICLE

Date

08-08-2016

Additional Links

Manuscript Submission

Journal

Innovare Journal of Medical Sciences
Vol 4 issue 4 2016 (August-September) Page: 6-7

Online ISSN

2321-4406

Statistics

215 Views | 38 Downloads

Authors & Affiliations

Dr. Jayesh K.m. Rajgopal
Gandhi Medical College
India

Dr. Kajal Shilpi
Gandhi Medical College
India

Arun Kumar Srivastav
Professor and Head, Department of Pharmacology Gandhi Medical College
India


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