English

Abstract

CONTEXT: Adverse Drug Reactions (ADRs) are a growing problem throughout the world causing significant patient morbidity and mortality, therefore, its monitoring has become exceedingly important in today's practice of medicine. In a country with limited medical and financial resources such as ours, eliminating or even reducing this potential source of morbidity and mortality is a worthy challenge. The primary source of information for pharmacovigilance is from spontaneous reporting by health care professionals. Spontaneous reporting of ADRs has played a major role in the detection of unsuspected, serious and unusual ADRs previously undetected during the clinical trial phases. The Pharmacovigilance Program of Indian (PvPI) was started with an aim of generation of ADR database in the Indian population subset. One of the major hurdles faced by PvPI was the under- reporting of ADRs. India, with its sizeable population and varied diseases and treatments, is still not a major contributor to the international ADR database. AIMS: The aim of our study is to deduce by a survey the knowledge, attitude and practice of pharmacovigilance amongst the various cadres of medical healthcare professionals (interns, postgraduate students and teaching faculty) in a tertiary care hospital. As spontaneous reporting forms the backbone of pharmacovigilance, especially in developing countries like India which lack a more structured approach, proper training in the know- hows of ADR reporting is mandatory for the healthcare professionals at the grass root level. We intend to investigate whether our healthcare professionals are inclined to, and are properly equipped to spontaneously and properly report ADRs. METHODS AND MATERIALS: This questionnaire based survey was conducted in Basaveshwar Teaching and General Hospital (BTGH), attached to M.R Medical College, Gulbarga, Karnataka. The study was conducted in the month of March-April 2014 on a total of one hundred (100) participants, comprising of interns, postgraduate students and teaching faculty of various clinical departments of BTGH. The study instrument was a pre designed questionnaire which was structured to obtain information on the knowledge of the ADRs reporting, the attitudes towards the reporting, and the factors that in practice could hinder the reporting among the doctors. RESULTS AND CONCLUSION: Our study revealed that the doctors in this tertiary care hospital were inadequately aware about the aim and methods of pharmacovigilance. Moreover, the primary tool of pharmacovigilance, that is spontaneous ADR reporting, was poorly understood by a vast majority of the participants. The International landscape of pharmacovigilance has changed from reactive nature, where it looked into safety as a mere regulatory requirement, to a more proactive approach which helps get safer drugs in the market.