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
- 1School of Public Health, University of Ghana
Abstract
BackgroundHerbal 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.
MethodsA 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.
ResultsA 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.
ConclusionADR 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.
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BibTeX
@misc{fianko2026adverse,
title = {{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}},
author = {H. Fianko and J. Sam and K. F.-M. Opuni and S. Seaneke and C. Santah and F. Ziga and P. Botwe and G. T. Sabblah and H. A. Bonful},
howpublished = {medRxiv},
year = {2026},
month = oct,
doi = {10.64898/2026.10.06.26364851},
url = {https://www.medrxiv.org/content/10.64898/2026.10.06.26364851v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - 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
AU - H. Fianko
AU - J. Sam
AU - K. F.-M. Opuni
AU - S. Seaneke
AU - C. Santah
AU - F. Ziga
AU - P. Botwe
AU - G. T. Sabblah
AU - H. A. Bonful
PY - 2026
DA - 2026/10/06
PB - medRxiv
DO - 10.64898/2026.10.06.26364851
UR - https://www.medrxiv.org/content/10.64898/2026.10.06.26364851v1
AB - BackgroundHerbal 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. MethodsA 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. ResultsA 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. ConclusionADR 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.
ER -