Abstract
AWARENESS ON ADVERSE DRUG REACTIONS AND ADVERSE DRUG REACTION REPORTING SYSTEM IN INDIA: A CONSUMER SURVEY
Rishab Dhir, Arshvir Kaur and Rajani Mathur*
ABSTRACT
Objective: Worldwide, adverse drug reactions (ADRs) have been recognized as the driving cause of mortality and morbidity. In India, PvPI has various methods to empower the reporting system of ADRs but direct reporting rate by the consumer is still low. So, this study was designed to determine the level of consumer or patient awareness on ADR and ADR reporting system in India amongst population of different age groups, profession and academic backgrounds etc. Method: A total of 100 people who gave consent were included as respondent for the self-administered survey questionnaire designed as a Google form and circulated via emails, online links, and the Whatsapp platform. A Pearson Chi (?2) test was performed to determine significant differences and associations between categorical variables and responses. Spearman's correlation coefficient was used in an analysis to predict correlation in variables. The data was analyzed using PSPP software version 1.4.1. Results: The response rate was 100% and majority of respondents were aware of ADR (69.3%), and had actually experienced adverse drug reactions (52%) with the use of allopathic medicine (64.4%) followed by cosmetic products. Few respondents knew about ADR through Pharmacists and Doctors (16.5 %), out of which male respondents were in majority but female respondents were found to be more active in reporting (64%). Only 43.6% of respondents were aware that they can directly report the ADR to the regulatory agency (mainly pharmacy and medical students not the non-medical professionals) but only 23% of respondents were aware of the reporting websites and ADR consumer form. ADR reporting system awareness was higher in younger adults (20-25 years) mainly male students from Pharmacy/Medical background but reporting rate remained low (?2, p value=0.001, T value 0.001) and reporting rate was more in male (?2, p value=0.025, T value 0.026) belonging to the profession of servicemen/private employees (?2, p value=0.005). Conclusion: In general, younger adult males with pharmacy/medical backgrounds had experienced more ADRs, had more awareness of ADRs and ADR reporting system but still the ADR reporting rate was found to be low amongst them due to be unawareness of any regulatory agency and consumer ADR website form.
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