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Asian Journal of Pharmacy and Technology
Year : 2019, Volume : 9, Issue : 1
First page : ( 49) Last page : ( 52)
Print ISSN : 2231-5705. Online ISSN : 2231-5713.
Article DOI : 10.5958/2231-5713.2019.00009.6

Pharmacovigillance: Drug Safety Monitoring

Chavhan Archana B.*, Bhoi Dipali M.

Shellino Education Society's, Arunamai College of Pharmacy, Mamurabad, Jalagaon-425001 [M.S.] India

*Corresponding Author E-mail: archanachavhan2011@gmail.com

Online published on 16 March, 2019.

Abstract

The safety concern of drug is now becoming the priority area. The thalidomide disaster of 1960’s opened the eyes of medication controllers as well as other concern body to establish a way to ensure drug safety; previously the issue was in shadow. The drug safety issues werestrengthen and systemized after the establishment of WHO programmed for international drug monitoring in 1968. Each medication is connected with gainful and undesirable or antagonist effect or adverse reaction (ADR). ADR is the common clinical problem, the number of ADRs reported have also resulted in an increase in the volume of data handled. Pharmacovigillance supports safe and appropriate use of drugs. Spontaneous reporting of ADRs is an essential component of pharmacovigillance. Adverse drug reactions are a common, frequently preventable cause of illness, disability and death. To understand the pharmacovigillance a high level of expertise is required to rapidly detect drug risk as well as to defend the product against an inappropriate removal. Safety and efficacy are the two major predominant considerations about any drug. Proactive pharmacovigillance throughout the product life cycle is the way formed and the future direction for drug safety. Thus, significance of pharmacovigillance is developing and became very important part of clinical research.

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Keywords

Pharmacovigillance, Adverse drug reactions, Clinical trials, Drug safety, Post marketing surveillance, Spontaneous reporting system.

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