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埃塞俄比亚传统草药监管实施情况:一项定性研究。

Traditional herbal medicine regulatory implementation in Ethiopia: a qualitative study.

作者信息

Usure Rashed Edris, Kebebe Dereje, Mekasha Yesuneh Tefera, Hasen Gemmechu, Chura Waritu Nuredin, Dubale Sileshi, Suleman Sultan

机构信息

School of Pharmacy, Department of Pharmaceutical Chemistry, Hawassa University, Hawassa, Ethiopia.

School of Pharmacy, Pharmaceutics, Jimma University, Jimma, Ethiopia.

出版信息

Front Pharmacol. 2024 Apr 12;15:1392330. doi: 10.3389/fphar.2024.1392330. eCollection 2024.

Abstract

Approximately 80% of the Ethiopian population predominantly depends on herbal medicines (HMs) for their primary healthcare needs. Nevertheless, worries regarding the safety, efficacy, and standard of herbal-based treatments have been escalating due to the lack of strong regulatory frameworks. Therefore, the study aimed to assess the presence of regulatory frameworks for traditional herbal medicines and their enforcement in Ethiopia. The qualitative-phenomenological study design was conducted from November 2021 to March 2022 G.C. The study included 25 regulatory official key informants (KIs) who work for national and regional medicine regulatory agencies, and 15 traditional herbal medicine (THM) practitioners who work at the regional level were purposefully selected for an in-depth interview (IDI). An in-depth interview guide was developed through the purposive sampling technique. The collected data were analyzed using thematic content analysis techniques. The study found that the current national medicine proclamation is deemed inadequate in the regulation of THM. Both conventional and traditional herbal medicines are regulated by a single agency. Weak legal enforcement, a lack of government commitment and support, resource constraints, and inadequate regulatory tools are the main challenges faced in THM regulation. Overall, the study found inadequate legal frameworks and weak THM regulatory implementations in Ethiopia. Consequently, it is critical for all regulatory authorities in Ethiopia to exert their utmost efforts to effectively regulate THM.

摘要

约80%的埃塞俄比亚人口主要依靠草药来满足其基本医疗保健需求。然而,由于缺乏强有力的监管框架,人们对草药治疗的安全性、有效性和标准的担忧日益加剧。因此,该研究旨在评估埃塞俄比亚传统草药的监管框架及其执行情况。本定性现象学研究设计于2021年11月至2022年3月(埃塞俄比亚历)进行。该研究包括25名在国家和地区药品监管机构工作的监管官员关键信息提供者(KIs),并特意挑选了15名在地区层面工作的传统草药(THM)从业者进行深入访谈(IDI)。通过目的抽样技术制定了深入访谈指南。使用主题内容分析技术对收集到的数据进行了分析。研究发现,现行的国家药品公告在传统草药的监管方面被认为是不足的。传统药物和传统草药均由单一机构监管。执法不力、缺乏政府承诺和支持、资源限制以及监管工具不足是传统草药监管面临的主要挑战。总体而言,该研究发现埃塞俄比亚的法律框架不足,传统草药监管实施不力。因此,埃塞俄比亚所有监管机构必须尽最大努力有效监管传统草药。

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