危害性藥品調製空間規範與應用

The Regulations of Hazardous Drug Compounding Facilities and Practice

一直以來如何安全調製危害性藥品，都是一個重要的議題，不論是透過良好的空間設計或是完善的人員教育訓練，目的都是為了提供高品質用藥，並降低第一線調製人員與給藥人員的暴露風險。隨著USP General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings的發表，為了提升調製人員、環境與給藥人員的安全，勢必需要整建或建立一個新的調製空間以符合最新規範。然而，USP General Chapter <800>內容繁複，若無事前通盤性了解與規劃，難以在一次建置過程即符合全部規範。有鑑於目前國內較少專門探討危害性藥品調製空間的準則與建議，因此本文統整國內外相關文獻，並分享本院整建經驗，提出實務執行的建議。

The safety of compounding hazardous drug is an important issue all the time. By providing a well-constructive compounding area and a sound system of personnel training, we could decrease the risk of exposure to hazardous drug during compounding and administration. As the USP General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings published, we have to re-model the existing area or construct a new area in order to improve the safety of person who is responsible for compounding and administrating hazardous drug. However, the USP General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings is too complicated for people to follow the whole criterion without any plan in advance. Since there is not much of guidance about hazardous drug compounding in Taiwan, in this article, we reviewed some guidance and shared our experience about re-modeling of oncology pharmacy in our hospital.