Abstract

ROLE OF POST-MARKETING SURVEILLANCE FOR MONITORING THE SAFETY OF DRUGS

Arnab Chakraborty*, Prof. (Dr.) S. K. Gupta and Dr. V. Kalaiselvan

Abstract

World‘s population is rising alarmingly with each passing day and so is their health related problems. Owing to their sedentary lifestyle and unhealthy eating habits there is a boom of a large number of lifestyle diseases like hypertension, diabetes, depression etc. which requires regular drug therapy. The availability of new improved medical interventions they can lead a happier and hassle free life. However, long term drug therapies are many a times are associated with fatal or moderate adverse drug reactions which puts the lives of the patients to a grave danger. Clinical trials conducted before marketing approval of drug products are not able to enlighten the researchers about many unintended effects of the drug products due to their limited sample size and short duration of study. Adverse drug reactions also impose a considerable amount of economic burden on the suffering patient and his family. To monitor and prevent these catastrophes Post-marketing surveillance is employed which is a robust method of drug event monitoring. With this ever increasing adverse drug events there is a continuous need of employing Post-marketing surveillance worldwide to safeguard the lives of patients against harmful effects of the same drug which is intended to benefit them.

Keywords: Post Marketing Surveillance, ICSRs, ADRs, Adverse Events, Pharmacovigilance, Investigational New Drug.