台灣毒劇藥品相關法令及管理改進芻議

An initiative to amend the regulation and management of poisons and dangerous drugs in Taiwan

目標：確保用藥安全為公共衛生的優先議題，本研究探討台灣毒劇藥品項及管理規範是否符合時代需求。方法：先檢視美國、澳大利亞、英國、歐盟、台灣、日本、中國大陸、香港及新加坡相關法規，進一步以中華藥典102項毒劇西藥品為基準，比較台、日、中、港、星毒劇性藥品定義、品項及管理措施，並利用百分比一致性及Kappa係數檢定品項相似性。結果：台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，台灣的毒劇藥品項與日本之一致（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。日本之毒劇藥品包括近期抗癌藥、免疫製劑及抗病毒藥，其品項數（148、39及39）較台灣多（3、0及0），而台灣的毒劇藥品近20年未增修，有些臨床少用的列載藥品在日本並未收載。有關毒劇性藥品管理規範，台灣缺少明確毒劇字樣標籤及貯存之規定，但相關紀錄留存時間較其他國家久。結論：台灣毒劇藥品之管理有改善空間，日本毒劇藥品管理相關規範可作為台灣之參考。

Objectives: Ensuring that drugs are used safely is a major priority in public health. The aim of the study was to investigate whether the listed items and related regulations for poisons and dangerous drugs (PDDs) in Taiwan were appropriate and timely. Methods: We initially evaluated the drug toxicity-related regulations in the United States, Australia, United Kingdom, European Union, Taiwan, Japan, China, Hong Kong and Singapore. The definitions, items and regulations related to PDDs were further compared among those in Taiwan, Japan, China, Hong Kong and Singapore. Based on the 102 items of western medicine considered to be PDDs in Taiwan, the item differences among countries were determined as percent agreements and kappa coefficients. Results: Taiwan and Japan showed the highest percent agreement, followed by Singapore, Hong Kong and China (64.7, 47.1, 40.2 and 4.9, respectively). Taiwan and Japan had substantial agreement (Kappa=0.63, P < 0.05) about PDD items. The regulations of Japan have criteria for judging whether a drug is poisonous or dangerous, and seem to be generally in line with the PDD items in Taiwan. The numbers of antineoplastic drugs, immunologic agents and antiviral agents listed as PDDs in Japan (148, 39 and 39, respectively) were much higher than those in Taiwan (3, 0 and 0, respectively). The list of PDD items in Taiwan has not been amended for almost 20 years, and some without current clinical use were not included in the Japanese regulations. Compared to other countries, the regulations in Taiwan lacked definite label and storage requirements for PDDs, but the period of record-keeping was longer than that in other countries. Conclusions: The Japanese PDD-related regulations could serve as a reference for Taiwan in improving the management of PDDs.