Masini Carla, Nanni Oriana, Antaridi Sara, Gallegati Davide, Marri Mattia, Paolucci Demis, Minguzzi Martina, Altini Mattia
Carla Masini, B.Pharm., is Senior Oncology Pharmacist, Laboratory of Oncology Pharmacy; Oriana Nanni, M.Stat, is Director, Unit of Biostatistics and Clinical Trials; Sara Antaridi, B.Pharm., is Pharmacist, Laboratory of Oncology Pharmacy; Davide Gallegati, B.Econ., is Cost Controller, Finance and Management Control; and Mattia Marri, B.Sc., is Data Manager, Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Istituto di Ricovero e Cura a Carattere Scientifico (IRST IRCCS), Meldola, Italy. Demis Paolucci, Ph.D., is Scientific Manager, Loccioni Humancare, Moie di Maiolati, Ancona, Italy. Martina Minguzzi, B.Pharm., is Director, Oncology Pharmacy; and Mattia Altini, M.D., is Healthcare Director, Healthcare Management, IRST IRCCS.
Am J Health Syst Pharm. 2014 Apr 1;71(7):579-85. doi: 10.2146/ajhp130489.
The quality and economic implications of manual versus automated preparation of antineoplastic drugs were compared.
This four-week study evaluated 10 routinely used antineoplastic drugs (fluorouracil, cyclophosphamide, gemcitabine, trastuzumab, bevacizumab, oxaliplatin, cisplatin, paclitaxel, irinotecan, and etoposide) prepared by manual and automated procedures. The accuracy of the dose of the active ingredient was calculated in terms of percent relative error for the difference between the nominal value indicated on the prescription and the actual value of the drug in the finished product. A comparative economic analysis of the manual and automated preparation procedures was performed by calculating the mean unit cost for each preparation at different production levels. Participating pharmacists and technicians completed a survey rating each preparation method in terms of performance, operator satisfaction, technology, and safety.
Of the 2500 i.v. antineoplastic preparations made in the pharmacy during the four-week study period, 681 were analyzed (348 using the automated procedure and 333 manually). Of these, 17 varied by more than 5% of the prescribed dose, and 1 varied by over 10%. Accuracy, calculated in terms of average percent relative error, was the highest and lowest during manual preparation. The preparation time for individual drugs was always higher when prepared using the automated procedure. A lower mean variable unit cost was observed for preparations made using the automated procedure. Questionnaire results revealed that operators preferred the automated procedure over the manual procedure.
Both the automated and manual procedures for preparing antineoplastic preparations proved to be accurate and precise. The automated procedure resulted in substantial advantages in terms of quality maintenance standards and risk lowering.
比较手工配制与自动配制抗肿瘤药物的质量及经济影响。
这项为期四周的研究评估了10种常用抗肿瘤药物（氟尿嘧啶、环磷酰胺、吉西他滨、曲妥珠单抗、贝伐单抗、奥沙利铂、顺铂、紫杉醇、伊立替康和依托泊苷），分别采用手工和自动程序进行配制。活性成分剂量的准确性通过相对于处方上标注的标称值与成品药物实际值之间差异的相对误差百分比来计算。通过计算不同生产水平下每种配制方法的平均单位成本，对手工和自动配制程序进行了比较经济分析。参与研究的药剂师和技术人员完成了一项调查，对每种配制方法在性能、操作人员满意度、技术和安全性方面进行评分。
在为期四周的研究期间，药房共配制了2500剂静脉用抗肿瘤制剂，其中681剂进行了分析（348剂采用自动程序，333剂采用手工程序）。其中，17剂的差异超过规定剂量的5%，1剂的差异超过10%。以平均相对误差百分比计算，准确性在手工配制时最高和最低。使用自动程序配制时，每种药物的配制时间总是更长。使用自动程序配制的制剂平均可变单位成本较低。问卷调查结果显示，操作人员更喜欢自动程序而非手工程序。
手工和自动配制抗肿瘤制剂的程序均被证明准确且精确。自动程序在质量维护标准和降低风险方面具有显著优势。
