Pharmacovigilance - An Analytical Approach to its Genesis and Contemporary Practice

K.G.Revikumar, Veena. R, G.P.Mohanta, Vidya Viswanad

Abstract: No medicine is 100% safe for everyone in all circumstances. A drug, which is pharmacologically effective, can always have some hazards with it. Pharmacovigilance helps to identify and respond to the risk-benefit profiles of marketed medicines. Various drug tragedies occurred during the 20th century in different parts of the world contributed significantly for the genesis and development of the concept of pharmacovigilance. The drug regulatory authorities of many countries and the WHO play significant roles in the promotion of the concept of pharmacovigilance at national and global levels. An inherent issue of pharmacovigilance is that most of the case reports are concerned not with confirmed, but with suspected cases of ADR. Till 1980s the practice was to consider an event as ‘possible’ if linked with a number of similar reports. Today various methods are available to attend the problem of determining causality of ADR, though they are not able to prove the same with conformity.
The discovery and development of modern medicines have changed the way in which diseases are managed and controlled. However, evidence continues to mount that adverse reactions are common to many medicines, old and new. The selection and use of the best, safest and low cost medicines for a given patient, or patients, out of the many choices available, requires considerable skill and awareness of the situation.
No medicine is 100% safe for all the people under every circumstance. A drug, which is pharmacologically effective, can always have some hazard. The hazard may be sometimes insignificant or may be acceptable in relation to the drug’s therapeutic action. Prior to marketing approval, drugs are subjected to various types of studies focusing on their pharmacokinetics and pharmacodynamics. Such studies usually involve a small population of subjects. Though intensive studies are made to know about absorption, distribution, metabolism and elimination (ADME) of drugs, such studies tell us only very little about certain characteristics of drugs after their marketing. In a country like India, where drug consumption is very high, there is tremendous scope and need for research in the area of adverse drug reactions.
Pharmacovigilance is the study of drug-related injuries for the purpose of making warning or withdrawal recommendations for medicines. It is a professionally governed process of identifying and responding to the risk- benefit issues related to the marketed medicines. Pharmacovigilance needs input from various health specialties including pharmacy, medicine and nursing.
Pharmacovigilance targets the monitoring of safety of drugs. It deals with the study of drug-related injuries for the purpose of warning, cautioning or alerting those concerned, about a particular drug used. According to WHO, ‘Pharmacovigilance is the science and its activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem’. Most of the techniques and study designs applied in pharmacovigilance are those employed in epidemiological studies. 


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