Adverse Drug Reaction Reporting Among Herbal Practitioners: A Mixed-Methods Study of Reporting Practices, Associated Factors, and Pharmacovigilance System Barriers in the Greater Accra Region, Ghana

Background: Herbal medicinal products are widely used in Ghana; however, adverse drug reaction (ADR) reporting associated with these products remains limited, posing challenges to pharmacovigilance and medicine safety surveillance. This study assessed trends in herbal medicine-related ADR reporting, determined the prevalence and factors associated with ADR reporting among herbal practitioners, and explored barriers to ADR reporting in Ghana. Methods: A mixed-methods study involving secondary pharmacovigilance data review, an analytic cross-sectional survey, and qualitative in-depth interviews was conducted. Secondary data on herbal medicine-related ADR reports submitted to the Ghana Food and Drugs Authority (FDA) between 2014 and 2024 were reviewed descriptively. The cross-sectional survey involved 271 herbal practitioners selected through multi-stage probability sampling across seven districts in the Greater Accra Region. Quantitative data were analysed using descriptive statistics and logistic regression in IBM SPSS Statistics version 26. The qualitative component involved 15 purposively selected participants, and thematic analysis was conducted using MAXQDA 2020. Results: A total of 117 herbal medicine-related ADR reports met the inclusion criteria and were analysed from the Ghana FDA pharmacovigilance database between 2014 and 2024. Among 271 surveyed herbal practitioners, 11.8% (95% CI: 8.0-15.6) reported submitting at least one ADR report during the preceding 12 months. In multivariable analysis, lack of ADR reporting forms or job aids (aOR = 0.11, 95% CI: 0.04-0.31) and lack of exposure to Ghana FDA ADR reporting guidelines (aOR = 0.09, 95% CI: 0.03-0.32) were independently associated with lower odds of ADR reporting. Qualitative findings identified causal uncertainty, inadequate training, weak reporting systems, commercial interests, and limited regulatory support as major barriers to reporting. Conclusion: ADR reporting associated with herbal medicinal products was limited within the national pharmacovigilance system and among surveyed herbal practitioners. System-level barriers, particularly limited access to reporting tools and FDA reporting guidance, were associated with lower reporting. Strengthening pharmacovigilance infrastructure, improving practitioner training, and increasing access to reporting tools may improve herbal medicine safety surveillance