[ Pharmaceutical Sciences Asia - ONLINE ]
Print ISSN 2586-8195 E-ISSN 2586-8470
[ Journal Abbreviation: Pharm.Sci.Asia ]
Mahidol University Journal of Pharmaceutical Sciences
  FORMER NAME   "Mahidol University Journal of Pharmaceutical Sciences" Published Since 1974


Pharm Sci Asia ; 38(1),

Pharmacovigilance: An Overview

Santosh KC and P. Tragulpiankit


The safety concern of drug is now becoming the priority area. The thalidomide tragedy of 1960ís opened the eyes of drug regulators as well as other concern body to establish a way to ensure drug safety, previously the issues was in shadow. The drug safety issues were globalised, strengthen and systematized after the establishment of World Health Organization (WHO) Programme for International Drug Monitoring in 1968. Every drug is associated with beneficial as well as undesirable or adverse effect. Adverse drug reactions (ADR) is the common clinical problem. The hospitalization due to ADRs in some countries is about or more than 10%. In addition, it is estimates that 10-20% of the hospital inpatient suffers from ADRs. Appropriate and effective monitoring of ADRs, i.e. pharmacovigilance, is the only best way to safeguard the public health. Spontaneous reporting system (SRS) is the first and most widely used method to report ADRs in spite of under-reporting as a major limitation. It is enable to early detection of new, rear and serious ADRs. Based on those reported cases signal is generated. Signal is new possible causal link between a suspected ADR and drug; which is previously unknown or incompletely documented. Disproportionality analysis is most commonly used method of data interrogation to figure out the association between drug and ADR of interest. The severity of under-reporting of ADRs is very high; it estimates that only 6% of ADRs are reported. There are many factors associated with under reporting of ADRs; categorized as personnel and professional characteristics of healthcare professional and their knowledge and attitude to ADR reporting. In terms of ADR reporting knowledge and attitudes of health professionals is strongly related. Under-reporting can be significantly improved by appropriate educational intervention.


Adverse drug reaction, Pharmacovigilance, Signal, Spontaneous reporting system, Under-reporting

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July - December 2011

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January - June 2011

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