Journal of Pharmacovigilance

Therapies with assurance of safety demands intensive post marketing surveillance

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

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

R S Thakur

Accepted Abstracts: J Pharmacovigilance

Abstract:

Assuring safety of therapy has always been major concern of patients. The drug safety environment has steadily changed from highly liberal to rigid control with power to assess and weed out ineffective and toxic products. Drug Authorities across the world require applying the same intensive and close monitoring initiatives on marketed drug product?s safety as for new drug development. This needs both scientific and legal approach aimed at collecting and analyzing more Pharmacokinetics and Pharmacodynamics data and comparing them with available data. Safety should be monitored on priority basis throughout the product life cycle so that its changing pharmacokinetics, pharmacodynamics and toxicological profile can be closely observed, accurately followed and appropriately interpreted in terms of clinical environment and therapeutic outcomes. This is a daunting task and authorities should be armed with necessary scientific basis and legal backing in achieving the goal. Reducing preventable harm from medications, detecting, investigating, managing, monitoring drug safety issues and useful communication about drug safety not only to the patients and/or their attendants but to the public at large deserve prime attention of all governments in the interest of public health. A scientifically organized evaluation team of Regulator needs to assess degree of risk to patient safety, on regular basis, not only for the new drugs but also for the established products because arrival of every new drug or new formulation in the market changes the therapeutic environment and the potential for drug interactions and Adverse Drug Reactions. This possibility cannot be ruled out blindly and theoretically. In order to develop an effective mechanism for this purpose, regulatory authorities must collaborate with Clinicians, Pharmacists, Nurses and social activists not only in the organized hospital set ups but also more actively in the unorganized sector i.e. General practitioners or Private practitioners, Community Pharmacists, Nurses and patient?s attendants(specially for children and geriatric patients).

Biography :

R S Thakur obtained his PhD (Pharmacy) from Jadavpur University, Kolkata. He is a Fellow of Institution of Chemists (India) and a Chartered Chemist. He is the Professor and Head of Department of Pharmaceutics at Krupanidhi College of Pharmacy, a premier Pharmacy college in Bangalore. He has published 38 papers in reputed journals and serving as Chief Editor of Journal of Pharmaceutical Research since 2002. He is recipient of Best Pharmacist Award (1986) and Acharya P. C. Ray memorial Gold Medal (1990).