Current status and future perspective of external herbal dispensaries preparing traditional herbal medicine in South Kor

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(2020) 20:354

RESEARCH ARTICLE

BMC Complementary Medicine and Therapies

Open Access

Current status and future perspective of external herbal dispensaries preparing traditional herbal medicine in South Korea: the first National-Wide Survey results Soo-Hyun Sung1, Ji-Eun Han1, Ji-Yeon Ryu1, Angela Dong-Min Sung1, Jung-Youn Park2, In-Hyuk Ha3, Kyeong Han Kim4, Jang-Kyung Park5 and Byung-Cheul Shin5*

Abstract Background: An external herbal dispensary (EHD) is a type of pharmacy that provides various types of personalized herbal medicines (PHMs) to other traditional Korean medicine (TKM) institutions. Such dispensaries were legalized by the Ministry of Health and Welfare (MoHW) in 2008 in South Korea. The purpose of this study is to understand the current status of the EHD facilities and their quality controls and compare them with the good manufacture practice (GMP) guidelines to contribute to the establishment of the safety and quality control criteria for PHMs. Methods: We contacted 107 EHD representatives or people in charge of the preparation of PHMs (TKM pharmacists) and invited them to complete a survey questionnaire; of the total, 81 responded. The survey questionnaire was developed in 3 stages: drafting, revision by external experts, and final editing. It consisted of 20 questions covering 3 sections: basic characteristics of EHDs, facility, and quality control. The survey was hosted online from December 2017 to January 2018 as guided by the MoHW. Results: The completion rate was 75.7% (n = 81). In terms of facilities, the five facilities (water supply, manufacture, pest control, hygiene management and warehousing) that corresponded to the legal requirements of EHD were mostly equipped, but the types of facilities and equipment differed. Two facilities (sterilization and crosscontamination that were not legally required for EHD were found to have mostly pharmacopuncture-EHD (P-EHD), but hardly any herbal medicine-EHD (H-EHD). In our findings regarding quality control of non-medicinal herbs, sensory evaluation that included checks for foreign bodies and deterioration were conducted. In terms of the quality control of herbal medicines, residual pesticides and heavy metals tests were performed and for pharmacopuncture, pH, salinity, sterility, and endotoxin tests along with gross examination were performed. In the end, we found that 6 of the 38 standard items as required by the Korea GMP were suitable. (Continued on next page)

* Correspondence: [email protected] 5 Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, Kyungnam 50612, Republic of Korea Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and i