臺灣醫院藥局藥品調製作業管理辦法之建議

A Proposal for Guidance of the Hospital Pharmacy Compounding in Taiwan

當因個別病人的特殊需求而處方市面上無法取得的藥品，經確認醫療上不可或缺峙，藥師得應用藥學專業知識與調製技巧，依照醫師的處方或藥囑，進行藥品的調製。為因應臨床上病人多樣醫藥需求，醫院藥局調製藥品日顯重要，先進國家近幾年亦陸續建立與修改藥局調製的制度及規範，讓藥品調製作業有可以依循的管理模式及作業流程。本文彙整與分析先進國家，包含歐盟、美國、加拿大、澳洲、日本等國的藥局調製藥品的管理法規、準則或指引，進而提出對臺灣醫院藥局藥品調製作業管理辦法之建議，期望醫藥界對藥局調製藥品有正確的認知，並讓藥品調製作業有可依循的管理模式，使病人用藥安全獲得最佳保障。

When physicians prescribe medicines which are not available on the market for specific individual patients, pharmacists shall apply their expertise and compounding techniques in preparing the drug products in accordance with prescriptions after the medical necessities are confirmed. The importance of pharmaceutical compounding implementation by hospital pharmacists is increasing in response to the diverse medical needs of patients during clinical treatments. Therefore, the developed countries have established and modified regulations of pharmacy compounding in recent years in order to guide and regulate the pharmacy compounding practice. The aim of this article was to propose the guidance of the hospital pharmacy compounding practice in Taiwan by reviewing and analyzing the Acts, regulations or guidelines of the compounding in developed countries, including the Europe, United States, Canada, Australia, and Japan. This paper not only delivers a correct concept of pharmacy compounding, but also drafts a guidance to regulate compounding practice in Taiwan, in order to provide a safer and better medical environment for patient care.