Demeke Henok, Hasen Gemmechu, Sosengo Teshome, Siraj Jafer, Tatiparthi Ramanjireddy, Suleman Sultan
Pharmacy Department, College of Health and Medical College, Haramaya University, Haramaya, Oromia, Ethiopia.
School of Pharmacy, Institute of Health, Jimma University, Jimma, Oromia, Ethiopia.
J Multidiscip Healthc. 2022 Jun 22;15:1383-1394. doi: 10.2147/JMDH.S366166. eCollection 2022.
Ethiopia is one of the world's oldest countries, with a fascinating history of herbal medicine. However, there is a lack of evidence for the regulatory framework for herbal medicines and its implementation. Thus, the aim of this study was to evaluate the policy governing herbal medicines regulation and its implementation in Ethiopia.
An archival review, a semi-structured interview with key informants, a cross-sectional study involving traditional healers, and an institution-based cross-sectional survey were conducted from June 15, 2020 to December 25, 2020. The qualitative data was transcribed using Microsoft Word 10, whereas the quantitative data was recorded and analyzed using SPSS 20 computer statistical software. The study's findings are summarized using descriptive statistics. In addition, multiple logistic regressions were performed to identify factors affecting regulation of herbal medicine (HM) in Ethiopia. Variables with p<0.05 were considered potential predictors.
According to all key informants, Ethiopia has yet to adopt distinct policies and laws on herbal medicine that may provide an independent regulatory framework. Similarly, the majority of respondents in an institution-based survey indicated that there were no defined policies (n=52, 57.3%), laws (n=53, 59.6%), or registration systems (n=67, 75.3%) for herbal medicine. However, traditional healers claimed that they are licensed by either the Woreda Health Bureau (n=21, 95.5%) or the Regional Health Bureau (n=1, 4.5%) to legally practise traditional herbal medicine. Besides, no traditional healer is licensed by Ethiopian Food and Drug Administration (EFDA) or Ministry of Health.
Ethiopia has yet to adopt distinctive herbal medicine policies and laws to provide an independent herbal regulatory system. Despite the fact that the EFDA has a mandate for herbal medicine regulation, traditional healers are licensed by the woreda and regional health bureaus, thus more investigation is needed.
埃塞俄比亚是世界上最古老的国家之一，有着引人入胜的草药医学历史。然而，草药药品监管框架及其实施缺乏相关证据。因此，本研究的目的是评估埃塞俄比亚草药药品监管政策及其实施情况。
于2020年6月15日至2020年12月25日进行了档案审查、对关键信息提供者的半结构化访谈、涉及传统治疗师的横断面研究以及基于机构的横断面调查。定性数据使用Microsoft Word 10进行转录，而定量数据则使用SPSS 20计算机统计软件进行记录和分析。研究结果使用描述性统计进行总结。此外，进行了多元逻辑回归以确定影响埃塞俄比亚草药药品监管的因素。p<0.05的变量被视为潜在预测因素。
所有关键信息提供者均表示，埃塞俄比亚尚未采用可能提供独立监管框架的独特草药药品政策和法律。同样，在基于机构的调查中，大多数受访者表示没有针对草药药品的明确政策（n=52，57.3%）、法律（n=53，59.6%）或注册系统（n=67，75.3%）。然而，传统治疗师声称他们已获得沃雷达卫生局（n=21，95.5%）或地区卫生局（n=1，4.5%）的许可，从而能够合法从事传统草药医学实践。此外，没有传统治疗师获得埃塞俄比亚食品药品管理局（EFDA）或卫生部的许可。
埃塞俄比亚尚未采用独特的草药药品政策和法律来提供独立的草药监管系统。尽管EFDA有责任监管草药药品，但传统治疗师由沃雷达和地区卫生局颁发许可，因此需要进行更多调查。
