臺灣醫院藥局調製藥品之初次調查及評估

The Preliminary Survey and Assessment of Hospital Pharmacy Compounding Medications in Taiwan

王雪如(Hseuh-Ju Wang) ； 楊秀琍(Hsiu-Li Yang) ； 林書巧(Shu-Chiao Lin) ； 林慧玲(Fe-Lin Lin Wu) ； 王春玉(Chun-Yu Wang) ； 沈麗娟(Li-Jiuan Shen) ； 林秋杏(Chiu-Hsin Lin)

《台灣醫學》 20卷6期 (2016/11) Pp. 570-578

https://doi.org/10.6320/FJM.2016.20(6).2

摘要

根據臺灣臨床藥學會調查目前國內醫院藥局調製的品項資料，發現品項多達百餘項。自19世紀末國際製藥工業蓬勃發展，至今絕大部分的藥品已由製藥工廠依據藥品優良製造規範進行製造，藥師的調製應該僅限於無市售製劑可資替代，惟須滿足病人醫療需求下始得進行。此次我們從國內各醫院藥局回饋的調製品項資料中，選取有兩家醫院以上（含）回覆的品項共35項，由臨床專家及藥學專家進行評估，發現這些品項中，有些是臨床不可或缺，但無市售的品項可供使用，須要藥師進行調製；有部分則是已有市售品可以取代。希望藉由本研究結果的分享，讓大家重新審視目前所調製品項的合理性外，也冀望能提供醫院藥師在接獲特殊臨床調製需求時，如何確認藥局調製的必要性，一個思考的方向及遵循的參考。

關鍵字

藥局調製 ； 調製

並列摘要

According to the survey by Taiwan Society of Health-system Pharmacists (TSHP) on the status of hospital pharmacy compounding, there were more than one hundred items of compounded medications prepared by hospital pharmacies. Since the end of 19th century, the pharmaceutical industries were well developed in the world. The majority of medications are produced by pharmaceutical companies according to the Good Manufacturing Practice nowadays. Although pharmacists are authorized to practice compounding, it should be limited to non-commercially available products which could not be found in the market to meet the medical needs of the patients. The appropriateness of the top 35 items of formulations from this survey was further evaluated by the clinical and pharmaceutical experts. We found that among these items, some are clinically indispensable but not commercially available, so pharmacists have to prepare the medication by themselves. However, others were found that could be substituted by commercial products. Through this paper we would like to share how to do the assessments of these compounding product items. It allows us to re-evaluate the current compounded medications, and also to provide hospital pharmacists approaches to handle the requests of compounding from physicians.

並列關鍵字

pharmacy compounding ； compounding

參考文獻

林書巧、楊秀琍、吳以安、林慧玲、沈麗娟、王春玉、王雪如：美國醫院藥局調製相關規範。臺灣臨床藥學雜誌 2015;23:181-7. [SC Lin, HL Yang, YA Wu, et al: Regulations of the Hospital Pharmacy Compounding in the United States. Formosa Journal of Clinical Pharmacy 2015;23:181-7]

楊秀琍、林書巧、吳以安、林慧玲、沈麗娟、王春玉、王雪如：簡介歐盟國家現今醫院藥局調製相關規範。臺灣臨床藥學雜誌 2015;23:91-8.[ HL Yang, SC Lin, YA Wu, et al: Introduction of the current regulations of the hospital pharmacy compounding in European countries. Formosa Journal of Clinical Pharmacy. 2015;23:91-8]

Gudeman J, Jozwiakowski M, Chollet J, et al: Potential risks of pharmacy compounding. Drugs RD 2013;13:1-8.

Council of Europe: European Pharmacopoeia Commission, European Directorate for the Quality of Medicines &. European pharmacopoeia. 8th ed ed. Strasbourg, Council Of Europe, 2014.

British Pharmacopoeia Commission: British pharmacopoeia 2015. London: Stationery Office, 2014.