Journal of Pharmacovigilance

Ecopharmacovigilance and its impact on clinical practice

3^rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

October 27-29, 2014 Hyderabad International Convention Centre, India

Khushbu B Vaghasiya

Posters: J Pharmacovigilance

Abstract:

With growing years of technological advances, newer and more effective drugs are being manufactured and are used on an ever growing scale for people with medical conditions. Pharmacovigilance activities are done for monitoring, detection, assessment, understanding and prevention of any obnoxious adverse reactions to drug at therapeutic concentration on animal and human beings. With growing research in the field of ecology and environment, many of the adverse effects of these on the environment have come to light. And it has given a birth to the science of Ecopharmacovigilance. It has been an area of novel interest. It is too broad and not even defined in a clear manner. It aims to ensure that significant environmental issues associated with pharmaceuticals in the environment are identified in a timely way, and managed appropriately. The greatest challenge in EPV is of signal detection in environment and establishment of cause and effect. EPV has become a research topic in Europe and North America. A number of findings related to rising level of some drugs and their adverse effects on the flora and fauna has necessitated some action by regulatory agencies like FDA and European Union. And Environmental Risk Assessment (ERA) is a regulatory requirement prior to new drug launch. But still there is no proper protocol for monitoring potential adverse effects on environment after the product is launched. There should be laws and regulations on EPV, rational medication, drug take back programmes, policy guided and scientific researches on EPV by pharmaceutical firms and academia. In this review article, focus is on what EPV means in clinical practice and there what practical measures can be taken to assess environmental risks across product life cycle, particularly after launch of new drug, to ensure that our risk assessment and understanding of pharmaceuticals in the environment remain scientifically and ecologically relevant. These include: tracking environmental risks after launch of product, define cause and effect via literature monitoring, using Environmental Risk Management Plans (ERMPs) as a centralized resource for the assessment and management of the risk of drug throughout its life cycle. Keeping the global EPV as a prospective measure, in India we need to increase transparency and availability of environmental data for medicinal products.

Biography :

Khushbu B Vaghasiya is pursuing residency in Pharmacology (3rd year), GMC, Surat affiliating VNSGU. She has published one article in international journal. Presently she is working on project ?Estimation of thyroid profile in patients of Diabetes mellitus?.