Consumer adverse drug reaction reporting is a new concept in Pharmacovigilance which contribute to the enhancement of existing drug safety practices. At present, consumer adverse drug reactions reporting system exist in 44 countries which contributes 9% of the total adverse drug reaction reports. To begin with promoting culture of consumer adverse drug reaction reporting in our country, it is first imperative to check the awareness on adverse drug reaction reporting among consumers.
Objective: To determine level of consumer or patient awareness on adverse drug reaction reporting system in India.
Methods: The present study was a cross-sectional study which was conducted for a period of 4 months among patients hospitalised at All India Institute of Medical Sciences, New Delhi. Main Outcome Measures: Knowledge on side effect or adverse effect of medicines, proportion of respondents experienced adverse drug reactions, whether participants reported adverse drug reactions, their perception towards reporting adverse drug reactions, awareness on existing system of Pharmacovigilance in India and their preferable mode of reporting adverse drug reactions in future.
Results: Of the 1000 questionnaires distributed, only 770 completed questionnaires were returned giving the overall response rate as 77%. A majority (74%) of respondents were aware of adverse drug reactions, of which only 29.4% had experienced adverse drug reaction. Only 8.9% of respondents thought of reporting adverse drug reactions while 40.6% considered it is important to report adverse drug reaction. Doctors were considered to be the right person for reporting adverse drug reactions among 73.2% of respondents. A poor awareness was observed among consumers (4%) on the existence of National Pharmacovigilance Programme in India. Over 78.5% of respondents feel consumers should be involved in adverse drug reaction reporting and 86% were willing to report adverse drug reactions if they were provided with the convenient method of adverse drug reaction reporting. Majority (53.8%) of respondents found online reporting of adverse drug reactions as the most convenient method.
Conclusion: The survey of awareness among patients at All India Institute of Medical Sciences indicates low awareness and it could be improved by introducing educational interventional programs.