Awareness among consumers on adverse drug reaction reporting system in India - A cross-sectional questionnaire-based study

The adverse drug reaction (ADR) reporting system in India came into existence in 2010 through an initiative by the Government, the Pharmacovigilance Programme of India (PvPI), considering the social and economic consequences of drug effects. Though the system is functioning effectively for almost a decade, there has been a lacuna in reporting due to the lack of awareness among the patients who are the direct consumers. Medicine side-effects reporting is the newest initiative started in 2014 by PvPI, and the forms for consumer reporting is made available in over 10 different Indian languages like Tamil, Hindi, etc. It is imperative to determine the level of awareness among the public regarding drug side-effects and the existence of a National Programme to monitor the same, especially in a country like India with a population of nearly 1.38 billion. The aim of this study was to determine the awareness among the general population about the ADR reporting system in India. This cross-sectional study was done over a period of one year amongst the general public in South India. Data was collected from about 338 participants using a standardized questionnaire and analyzed descriptively using SPSS statistical software version 24. The overall response rate was 93.8%, and the mean age was 35.62 ± 10.43 years. Though the respondents had sufficient knowledge (66%) about ADRs, their awareness about the reporting system was very poor (19%). Reporting through phone (78%) was preferred over-reporting through specific forms (10%). To conclude, our study emphasizes that public participation and awareness are crucial in strengthening the existing system of Pharmacovigilance.