臺灣毒劇藥品相關法令及管理改進芻議

An Initiative on the Amendment of Regulations and Management for Poisons and Dangerous Drugs in Taiwan

廖怡清(Yi-Ching Liao)

指導教授 ： 李志恒

高雄醫學大學/藥學院/藥學系碩士在職專班/碩士(2015年)

https://doi.org/10.6832/KMU.2015.00153

摘要

目標：確保用藥安全為公共衛生的優先議題，本研究探討臺灣毒劇藥品項及管理規範是否符合時代需求。方法：先檢視臺灣、日本、中國大陸、香港、新加坡、美國、澳大利亞、英國及歐盟相關法規，進一步比較臺、日、中、港、星毒劇性藥品定義、品項及管理措施。其中西藥品項之比較以中華藥典102項毒劇西藥品為基準，利用百分比一致性及Kappa係數檢定臺灣毒劇藥品西藥品項與其他國家地區相較，是否有收載之相似性；中藥則就各國家地區收載之藥材直接作品項比較。結果：西藥品項部分，臺灣與日本百分比一致性最高(64.7)，其次依序為新加坡、香港及中國大陸(47.1、40.2及4.9)；日本毒劇藥品有明確定義及審定基準，臺灣的毒劇西藥品項與日本之一致高(Kappa=0.63, P < 0.05)，品項收載及分類亦符合日本毒劇藥審定基準；日本之毒劇藥包括抗癌藥、免疫製劑及抗病毒藥，其品項數(148、39及39)較臺灣多(3、0及0)，而臺灣的毒劇藥品近20年未增修，其中臨床少用的列載藥品在日本並未收載。中藥部分，有些毒性劇烈的中藥符合日本毒藥劇藥審定基準，中國大陸或香港已列為毒性中藥，但臺灣尚未列管。另有關毒劇性藥品管理規範，臺灣缺少明確毒劇字樣標籤及貯存規定，相關紀錄留存時間較其他久。結論：有鑑於臺灣毒劇藥品項多年未增修，毒劇藥品之管理似仍有改善空間，日本毒劇藥品管理相關規範或可作為臺灣之參考。

關鍵字

毒劇藥品 ； Kappa係數檢定 ； 管理規範

並列摘要

Objectives: Ensuring that drugs were used safely was a major public health priority. The aim of the study was to investigate whether the items and related regulations of poisons and dangerous drugs (PDD) in Taiwan were appropriate and timely. Methods: First we evaluated the regulations about drug or chemical substances in the USA, Australia, UK, EU, Taiwan, Japan, China, Hong Kong and Singapore. Further, the definitions, items and regulations of PDD were compared among Taiwan, Japan, China, Hong Kong and Singapore. Based on the 102 western medicine items of PDD in Taiwan, the item differences among countries were represented by percent agreement and kappa coefficient. For Chinese medicine, the item dissimilarities were compared directly. Results: Taiwan and Japan showed the highest percent agreement in western medicine items, followed by Singapore, Hong Kong and China (64.7, 47.1, 40.2 and 4.9). Taiwan and Japan had a substantial agreement (Kappa=0.63, P < 0.05) in the western medicine items of PDD. The regulations of Japan, which had criteria for judging whether a drug was poisonous or dangerous, could be generally in line with the western medicine items of PDD in Taiwan. The antineoplastic drugs, immunologic agents and antiviral agents listed as PDDs in Japan (n=148, 39 and 39, respectively) were much more than those in Taiwan (n=3, 0 and 0, respectively). The western medicine items of PDD in Taiwan had not been amended for almost 20 years, and some without current clinical use were not included in the Japanese regulations. Some toxic Chinese medicines meeting the PDD criteria in Japan were regulated in China and Hong Kong, but not in Taiwan. Compared to other countries, the regulations in Taiwan lacked definite PDD label and storage requirements, but the period of records-keeping was longer than others. Conclusions: Due to the lack of update with PDD items in Taiwan, the Japanese PDD-related regulations could be a reference for Taiwan to improve the management of PDDs.

並列關鍵字

poisons and dangerous drugs ； kappa coefficient ； regulations

參考文獻

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