Introductory Chapter: Pharmacovigilance

Abstract

Consuming a drug is equivalent to consume a risk. It is only when the benefit associated with the drugs are more than the risk, that the consumption of a drug is justified. Thus, it is benefit versus risk ratio of the drug which decides whether a drug is to be taken or not. The next question is how to measure risks and how to measure the benefits. Due to individualization of drugs to patients, it is the clinical judgment of the physician to identify what will benefit the patient. At the same time, risk associated with the drug can be ascertained by observations related to pharmacovigilance. The studies related to pharmacovigilance indicate what are the possible risks associated with the drug. Even drug can be associated with possible adverse reactions, intended or unintended. The only exception to this generality is the case of drug which is given in case of deficiency of specific components like vitamins or minerals. It is the study of possible adverse reactions of drugs which constitutes the essential content of Pharmacovigilance. This takes us to the definition of Pharmacovigilance. Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other possible drugrelated problems. [1] Spontaneous reporting of adverse events and adverse drug reactions is the commonest method utilized for generating safety data. Major aims of pharmacovigilance are as follows: