From Awareness to Action: A Systematic Review of Public Awareness, Reporting Barriers and Strategies to Strengthen Adverse Drug Reaction Reporting to Pharmacovigilance Systems

Abstract

Background: Spontaneous reporting is the cornerstone of post-marketing drug safety surveillance, but under-reporting limits what it can detect. Direct patient reporting, pharmacist involvement and hospital-based programmes have been introduced to widen and deepen reporting, yet the evidence on public awareness and on what improves reporting is scattered across study designs and reporter groups.
Objective: To synthesise evidence on (i) public and patient awareness of adverse drug reaction (ADR) reporting systems, (ii) barriers to and facilitators of reporting by patients and professionals, and (iii) the effect of pharmacist-led and hospital-based strategies, and to establish whether urban–rural comparisons were available.
Methods: The review followed the PRISMA 2020 statement. PubMed/MEDLINE, Embase, Web of Science, Scopus and the Cochrane Library were searched up to early 2026, supplemented by manual searches. Data were extracted into a standardised matrix, methodological limitations were appraised according to study design, and findings were synthesised narratively.
Results: Twenty-five studies (23 primary studies and two narrative reviews) from 15 countries, published between 1989 and 2025, were included. Twelve examined public or patient awareness, knowledge or usability of reporting tools; five examined reporter groups or national system performance; four examined pharmacist-based reporting; and four evaluated hospital-based detection programmes. Awareness and knowledge were low wherever they were measured: 8% of respondents were aware of the national system in Malaysia, 8.5% had heard of the Yellow Card Scheme in Great Britain, only 4.3% of Saudi respondents had adequate knowledge, and 98.8% of Indian inpatients were unaware of the national programme, even though attitudes towards reporting were largely positive where assessed. Recurring barriers were complex reporting forms, uncertainty about whether a symptom was drug-related, reliance on healthcare professionals, limited time and weak institutional capacity. Educational intervention improved awareness (by 41.2% for the need for a hospital pharmacovigilance centre in Pakistan), pharmacist involvement facilitated patient reporting in Italy, and structured hospital programmes increased report numbers (from 0.4 to 20 per month in one programme). No included study reported urban–rural disaggregated data.
Conclusion: Low awareness and practical barriers, rather than unwillingness alone, appear to limit ADR reporting. Simpler reporting tools, pharmacist-linked reporting, targeted education and structured institutional detection are the best-supported strategies. Future studies should use validated instruments, representative sampling and report results by place of residence.