Pharmacovigilance of herbal medicines in Ghana- Knowledge, perception and practice

Background: Herbal medicines (HM) are used particularly in low-middle income countries for primary healthcare. The World Health Organization reports that about 70 % of Ghana's population use HMs and it has been integrated into the mainstream healthcare delivery system in Ghana. HMs contain pharmacologically active constituents; hence they are capable of causing adverse drug reactions (ADRs). It is therefore essential that effective Pharmacovigilance (PV) systems are researched into and developed to ensure the safety of HMs consumed. This study aims to assess the knowledge, perception and practice of Pharmacovigilance among users and practitioners of Herbal Medicine in Ghana. Methods: A cross-sectional mixed method design using semi- structured questionnaire was employed to collect data from 2550 users and 300 practitioners across all sixteen (16) Regional Capitals of Ghana. The data was edited, cleaned, coded, entered, and summarized using the statistical software IBM SPSS Statistics 26. A p-value of 0.05 was used to determine the statistical significance. Results: Among users, 5.2 % had an idea of what ADRs were, 43.6 % gave description of various signs as their understanding of ADRs, 3 % had experienced ADRs. Majority (85 %) of respondents agreed that ADRs from HMs should be reported with 77.4 % sharing their willingness to report suspected ADRs if they ever experienced any. However, 66 % of users were unfamiliar with the reporting system for ADRs in Ghana. Among the practitioners, 69 % claimed awareness of the term ADRs, 72 % were aware of a National Centre for PV with 24 %, 13.3 % and 1 % mentioning specific regulatory bodies as responsible for PV in Ghana. Among the practitioners, majority (89 %) said ADRs from HMs are preventable, 52.6 % said reporting ADRs is a professional obligation to them, 90.3 % said reporting ADRs will increase patient safety, 16.7 % said they should be paid for reporting ADRs whiles 77.7 % said it is necessary to establish PV monitoring centres in facilities offering HM services. Positive associations were established between gender, frequency of use of HMs, age, educational level, and the occurrence of ADRs. Conclusion: This study revealed gaps in knowledge and reporting of ADRs among users and practitioners despite the positive shift in perception about ADRs and the safety of HMs. Thus, there is the need for improved awareness, clearer reporting pathways, and dedicated monitoring centers to enhance effective PV practices and improve patient safety in HM use.