Strengthening pharmacovigilance through patient reporting: a scoping review of awareness, barriers, and facilitators

Adverse drug reactions (ADRs) significantly impact global healthcare systems, yet patient participation in pharmacovigilance remains underutilised. This scoping review synthesises evidence on patient awareness, barriers, and facilitators for ADR reporting to inform strategies for enhancing pharmacovigilance systems.

Following the Arksey and O'Malley framework, we conducted a scoping review of studies published up to 2025 across PubMed, Scopus, Embase, Web of Science, Cochrane Library, and Google Scholar. Two independent reviewers screened titles, abstracts, and full texts, extracted data, and synthesised findings using thematic and descriptive analyses.

A total of 1,420 articles were identified, of which 42 studies from 25 countries met the inclusion criteria. Most employed quantitative descriptive designs (n = 27), followed by mixed-methods (n = 7) and qualitative approaches (n = 5). Sample sizes ranged from 15 participants to over 500,000 ADR reports from national databases. Data collection methods included questionnaires, interviews, and electronic surveys, while six studies analysed secondary data from pharmacovigilance systems such as VigiBase and the Yellow Card Scheme. Key barriers included limited knowledge, complex reporting processes, and a lack of feedback, whereas facilitators included healthcare professional support and simplified, user-friendly platforms.

Patient reporting is hindered by systemic and educational gaps, especially in LMICs. Strategic interventions, such as simplified reporting mechanisms, nationwide awareness campaigns, digital tool integration, and healthcare provider training, are critical to empower patients as active pharmacovigilance contributors. Future efforts must prioritise culturally tailored approaches and equitable access to reporting infrastructure.