A Review on Adverse Drug Reaction Monitoring and Current Status of Pharmacovigilance Activities in India

Abstract

Pharmacovigilance is the science and activities   relating   to   the   detection, assessment, and prevention of adverse effects or any other possible drug-related problems, including herbal medicines. Adverse drug reactions (ADR) is one of the common causes of prolonged   hospitalization   and   death   among   patients. Pharmacovigilance plays a key role in the surveillance of adverse    drug reactions. Around    10%    of    hospital admissions are estimated to be due to ADRs and about 5-20% of hospitalized patients experience a serious ADR. Pharmacovigilance plays a prominent role in establishing    the    safety    profile    of    marketed    drugs pharmacovigilance is an important and integral part of the safe practice of medicine. Only a small proportion of the ADR are reported to the central monitoring center.  Most of the ADR’s go unrecognized in the guise of a disease or a symptom of a disease. Spontaneous reporting is a method of ADR identification that relies on healthcare professionals to identify and report suspected ADRs. The major limitation of this method is under-reporting. Patient reporting of ADRs aims to increase the number of reported ADRs and is, therefore, another way to improve treatment safety. Hence there is a need  for  better reporting  of  ADRs  and  the  creation  of  a  database  that allows  feedback  and  drug  alerts  by  the  central  agency (PvPI)  and  better  management  of  patients.  Causality assessment is  the  method  by  which  the  extent  of  the relationship  between  a  drug  and  a  suspected  reaction  is established. The majority of ADRs were probable in causality and moderate in severity.  However, the preventability assessment was a challenge for the data of this study. There is a necessity to increase awareness of the importance of ADR reporting among healthcare professionals must be followed.