Drug safety and Pharmacovigilance: An overview

Abstract

Adverse drug reactions (ADRs) have a major impact on public health, reducing patient’s quality of life and imposing a considerable financial burden on the health care systems at a time when many health care systems are under considerable financial strain. All healthcare providers have roles to play in maintaining a balance between a medicine's benefits and risks. Once a drug is available to the public, making a determination about its safety is the shared responsibility of all who are part of the prescribing process, including patients. The role of healthcare professionals is vital in recording and reporting suspected ADRs in order that regulatory agencies are alerted of emerging safety concerns and thereby facilitating timely and appropriate action. Pharmacovigilance is an important exercise for monitoring of drug related issues after marketed in “real world setting”. Pharmacovigilance and all drug related issues are important for everyone whose life is being impacted any way by medical interventions. The evolution of Pharmacovigilance in recent years has growing importance as a science critical to effective clinical practice and public health science. The national Pharmacovigilance centers have become a significant influence on the drug regulatory authorities, at a time when drug safety concerns have become increasingly important in public health and clinical practice. This paper unfolds the basics of drug safety and other important aspects of Pharmacovigilance. Keywords: Adverse drug reactions, Pharmacovigilance, Drug regulation.