Kim Mikyung, Woo Yeonju, Han Chang-Ho
Department of Internal Medicine, College of Korean Medicine, Sangji University, Wonju, Republic of Korea.
Department of Physiology, College of Korean Medicine, Sangji University, Wonju, Republic of Korea.
Integr Med Res. 2021 Mar;10(1):100467. doi: 10.1016/j.imr.2020.100467. Epub 2020 Jul 1.
While the use of herbal and traditional medicine (H&TM) has been extensive worldwide, the current status of H&TM management in pharmacovigilance remains to be investigated. To date, there is little information regarding the use of the classification/coding system (CCS) to detect signals for certain drugs within databases built on the basis of the spontaneous reporting system (SRS). The purpose of this study is to investigate the status of the SRS and CCS for H&TM in the pharmacovigilance systems of various countries around the world.
An e-mail survey was performed from late December 2018 to early January 2019 with 54 experts in pharmacovigilance. The results based on the information provided by the respondents were summarized.
Fourteen experts from 13 countries responded to the survey. Eleven countries/regions were found to already include H&TM in their SRSs, managing only limited range of H&TM. Of the 9 countries/regions that provided the information on the status of CCS for H&TM in their domestic pharmacovigilance systems, only China had a separate CCS for H&TM.
Revising the current pharmacovigilance systems to include or expand the range of H&TM, and developing an internationally harmonized system to classify and code H&TM suitable to the unique characteristics of H&TM are critical and overall beneficial.
虽然草药和传统药物（H&TM）在全球范围内的使用广泛，但药物警戒中H&TM管理的现状仍有待研究。迄今为止，关于在基于自发报告系统（SRS）建立的数据库中使用分类/编码系统（CCS）来检测某些药物信号的信息很少。本研究的目的是调查世界各地各国药物警戒系统中H&TM的SRS和CCS的现状。
2018年12月下旬至2019年1月上旬，对54名药物警戒专家进行了电子邮件调查。根据受访者提供的信息对结果进行了总结。
来自13个国家的14名专家回复了调查。发现11个国家/地区已将H&TM纳入其SRS中，但仅管理有限范围的H&TM。在9个提供其国内药物警戒系统中H&TM的CCS状况信息的国家/地区中，只有中国有单独的H&TM CCS。
修订现行药物警戒系统以纳入或扩大H&TM的范围，并开发一个适合H&TM独特特征的国际统一的H&TM分类和编码系统至关重要且总体有益。
