Consumers’ experiences and perspectives on reporting adverse drug reactions using digital tools: a qualitative study

INTRODUCTION: Spontaneous adverse drug reactions (ADRs) are underreported. Digital reporting systems are increasingly used to address this issue; however, limited knowledge exists about the barriers and facilitators influencing their use by consumers. AIM: To explore facilitators and barriers influencing consumers' use of digital tools for ADR reporting, and to identify the factors, expectations and preferences that affect their engagement with these tools. METHOD: An exploratory qualitative descriptive study using semi-structured in-depth interviews was conducted among Australian adults who self-reported having experienced an ADR. Interviews were conducted face-to-face or via Zoom, audio-recorded, transcribed verbatim, and analysed inductively using reflexive thematic analysis. Themes were mapped onto domains of the Combined Technology Acceptance Model and Theory of Planned Behaviour (C-TAM-TPB) framework. RESULTS: Fourteen participants were interviewed. Consumers expressed positive intentions to use online ADR reporting tools. Identified facilitators included user-friendly and accessible tools that are simple to complete, the use of images to aid comprehension, integration with existing patient health records, the ability to submit reports to both healthcare professionals and regulators, and a tool designed specifically for consumers using layperson language. Identified barriers included lack of awareness that consumers could report ADRs using online tools, the need for registration, complex medical terminology, compulsory fields, and the absence of feedback after submission. CONCLUSION: Consumers were willing to use online ADR reporting tools but were largely unaware of their existence. Enhancing usability through user-friendly design, and reporting forms specifically designed for consumers may increase engagement. Addressing barriers such as lack of awareness, registration requirements, medical jargon, and lack of feedback may improve usability and contribute to strengthening pharmacovigilance systems.