社團法人臺灣臨床藥學會

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【綜述】醫院藥局無菌調製藥品之綜合性探討
A Comprehensive Review of the Hospital Pharmacy Sterile Products Compounding
GDP、GMP、調製、無菌製劑、品質確保、Good Dispensing Practice, Good Manufacturing Practice, compounding, sterile products, quality assurance
黃志偉Chih-Wei Huang 、葉明功Ming-Kung Yeh 、劉文雄Wen-Shyong Liou
1三軍總醫院 臨床藥學部
醫院調製部門具有配合醫療多元、多變性的功能與角色,然從法規的層面來說,醫院調製部門的作業既要遵守GDP的規範,亦應合乎GMP的相關要求;且藥師必須了解調製藥品所需的必要相關知識並熟練相關的操作技巧。其中,無菌製劑在現今醫學中心調製部門的工作中佔了很大的一部份,藥師對於了解相關的無菌規範及如何執行品質確保的工作是責無旁貸。而安全性的考量更是必須被重視的議題;不管是調製者的安全或病人的安全,都應該透過嚴密的作業流程去把關。以三軍總醫院為例,在化療藥品調製的作業流程中建立多個檢核點之後,已成功地讓化療藥品調製面的錯誤率降低達五倍之多。綜合來說,當代醫院調製部門的藥師必須懂得更多、想得更多、做得更嚴謹,才能提供安全、有療效的製劑,真正扮演好其重要專業角色。

The functions of compounding unit in hospital pharmacy coordinate with the variety of clinical required medication. Based on regulations, the practices in compounding pharmacy obey the Good Dispensing Practice, and Good Manufacturing Practice standard. Pharmacists are responsible for understanding the related knowledge, how to compound sterile products and make the products well quality assurance in the daily sterile compounding products. 
Patient safety is a hot issue for the compounding pharmacy; which pharmacists guard through the well-designed prepared process control. For example, after setting several checking points during the oncology medicine compounding process, we have reduced five times of the medication error rate on chemotherapy products compounding.
Providing safe and effective compounding products, pharmacists need to understand more on practicing and do more, regarding the compounding techniques and knowledge to play a really important professional role.
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