Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring

G Jeetu,G Anusha

doi:10.4103/0975-1483.66802

Abstract

Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. Recently, pharmacovigilance has been confined, mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors.

Highlights

Drug safety and pharmacovigilance remains a dynamic clinical and scientific discipline
Pharmacovigilance is defined by the World Health Organization (WHO) as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’;[1] it plays a vital role in ensuring that doctors, together with the patient, have enough information to make a decision when it comes to choosing a drug for treatment.[2]
The current global network of pharmacovigilance centers is coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review

Summary

INTRODUCTION

Drug safety and pharmacovigilance remains a dynamic clinical and scientific discipline. The current global network of pharmacovigilance centers is coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review This would consider contentious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. The WHO has supported the creation of an independent advisory panel composed of a broad spectrum of medical disciplines including clinical pharmacologists, regulators, academics and epidemiologists The functions of this panel will be to provide advice to WHO on safety issues relating to medicinal products, including its Collaborating Centre for International Drug Monitoring and through it to the Member States of WHO.[25]. A major focus must be to empower health practitioners and patients themselves with useful information that improves individual therapy, aids the diagnosis and management of medicine-induced disease, and generally leads to a reduction of iatrogenic diseases.[27,28,29]

CONCLUSION

Geneva

WHO Medicines Strategy