Abstract

AWARENESS, ATTITUDES, AND PRACTICES TOWARDS ADVERSE DRUG REACTION REPORTING: A CROSS-SECTIONAL STUDY IN A PREVIOUSLY UNEXPLORED EPIDEMIOLOGICAL AREA

*Dr. Jyothsnya S., Dr. Manjula M. J., Mrs. Gokila Vani M., Dr. Subashini Shanmuganandam

ABSTRACT

Background: Adverse drug reactions (ADRs) remain a serious challenge to global health, leading to avoidable hospitalizations and significant economic burden. Although pharmacovigilance programs have been implemented worldwide, under-reporting of ADRs is still a universal problem, particularly in regions where no previous epidemiological studies have been conducted. This study assessed awareness, experiences, and practices regarding ADR reporting among residents of a previously unstudied region. Methodology: A cross-sectional, questionnaire-based study was conducted in 2025 among 1,000 participants, with data collected on demographics, awareness of ADRs, past experiences, reporting practices, barriers, facilitators, and digital literacy. Data were analyzed using SPSS v25 and compared with studies published between 2015 and 2025. Results: Of the 1,000 participants, 56% were female and the predominant age group was 18–24 years (39%). Overallawareness of ADRs was high (93%), but only 43% of respondents knew how to report ADRs. About 62% had experienced ADRs, but only 29% had reported them. Doctors and pharmacists were the most preferred reporting channel (40%), followed by mobile apps (29%). The most common barriers included perceiving the reaction as not serious (28%), not knowing how to report (25%), and uncertainty about causality (20%). Facilitators included easier reporting mechanisms (47%) and more awareness campaigns (41%). Despite 86% of participants being moderate-to-advanced smartphone users, only 29% had ever used a mobile app for ADR reporting. Conclusion: The study highlights a gap between awareness and practice of ADR reporting. Despite high digital literacy, mobile app use for reporting remains limited. Strengthening awareness programs, simplifying digital tools, and integrating ADR reporting into community health initiatives may improve pharmacovigilance systems.

Keywords: Adverse Drug Reactions, Pharmacovigilance, ADR Reporting, Cross- sectional Study, Digital Literacy.