某醫學中心藥局調製非無菌製劑現況

當部分特殊病人所需藥品為臨床醫療必須但無市售品可供使用時，為使醫療得以進行，須由藥師來執行藥品調製。藥局調製藥品時的調製環境、設備、人員操作以及所使用的原料藥等都會影響到調製藥品的品質，與病人用藥安全息息相關。國內目前調製藥品相關的標準流程及查檢項目等正在研擬中，希望能凝聚共識，訂定藥局調製藥品的規範，來確保藥品品質及療效。某醫學中心藥局所進行調製的品項，係為醫療科部提出需求，由藥師進行風險評估，經院內藥事委員會同意後進行，除小兒磨粉分包及糖漿製劑外，目前共有12 項非無菌製劑。本文藉由分享本院進行非無菌製劑調製時，在調製場所的設施、調製設備、原料選擇及品管、人員訓練、調製程序、成品的標示及包裝，以及品質管制等自我規範的現況，對照美國藥典中關於非無菌製劑的調製規範，希望能提供藥局藥品調製作業管理的參考，以保障病人的用藥品質及安全。

關鍵字

藥局調製藥品；非無菌製劑；美國藥典第795 章

並列摘要

Pharmacy compounding is prepared by pharmacists when there are no commercially available medications to meet the clinical needs of individual patients. The quality of pharmacy dispensing is related to environment, equipment, personnel training, and ingredients, etc. The pertinent standard procedures for drug compounding in Taiwan hospital pharmacy are currently under elaboration. We hope to have a consensus on the guidelines for pharmacy compounding to ensure drug quality and efficacy. In a medical center in Taiwan, the request for the pharmacy compounding was usually initiated by the clinic physician from medical departments. When the Department of Pharmacy receives the request, the responsible pharmacists would prepare documents for the risk-assessment and approval from the Pharmacy and Therapeutics Committee. In addition to dividing the pulverized tablet and syrup preparation for pediatric patients, there are 12 non-sterile drug preparations are compounded currently. The aim of this paper is to demonstrate the process of non-sterile preparations, including the facilities, equipment, ingredient selection, personnel training, dispensing procedures, labeling and packaging, and quality control for pharmacy compounding in the hospital, and compared with non-sterile preparation guidelines in the U.S. Pharmacopeia (USP). Hopefully, this article can cover the important concepts of pharmacy compounding in a hospital to ensure the quality of compounding products and safety of patients.

並列關鍵字

Pharmacy Compounding ； Non-Sterile Preparations ； USP ＜795＞

國際替代計量

某醫學中心藥局調製非無菌製劑現況

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