Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring

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.

Evaluation of Frequency Adverse Drug Reactions in Tertiary Care Hospital of Kolkata, West Bengal, India

“…3 Pharmacovigilance (abbreviated PV or PhV) is the pharmacological science deals with detection, assessment, understanding and prevention of adverse effects and promotes the safe use of drugs. 4 In 2005, National Pharmacovigilance Program (NPP) was introduced by the Ministry of Health and Family Welfare further, which was revised in July 2010. This program is monitored by the Central Drugs Standard Control Organization (CDSCO), New Delhi.…”

Retrospective clinical analysis of adverse drug reactions associated with antiretroviral therapy in Tlokwe district, South Africa

“…1 It can be described as a dynamic umbrella term, which holds the key to effective ADR monitoring in practice to minimise ADRs and benefit patient populations. 2 In South Africa, the Medicines Control Council (MCC) and the National Pharmacovigilance Centre (NPC), as part of the National Department of Health (NDoH), facilitate the reporting of ADRs by health professionals, the management of safety data which arise during clinical trials, spontaneous reporting and post-marketing surveillance. 3 Public health pharmacovigilance promotes risk minimising of preventable ADRs, whereas institutional or clinical pharmacovigilance targets hospitals and clinics aiming to reduce mortality and morbidity associated with ADRs.…”

Effective Reporting by Pharmacist in Pharmacovigilance Programme of India

“…Decade's back Health professionals play a vital role in safeguarding the health of the population by ensuring the benefits of use of medicine and outweigh the risks associated with its use. In today's era, the pattern has changed even different categories of health professional are working out on ADR reporting [13]. Similarly the role of pharmacist has also changed from merely the dispensing of drugs to health care and patient safety, looking into Indian Scenario, reports from pharmacist are acceptable.…”