Iwamoto Takuya, Morikawa Takuya, Hioki Miki, Sudo Hirofumi, Paolucci Demis, Okuda Masahiro
Department of Pharmacy, Mie University Hospital, 2-174 Edobashi, Tsu, Mie 514-8507 Japan.
Loccioni Humancare, Moie di Maiolati, Ancona, Italy.
J Pharm Health Care Sci. 2017 Apr 24;3:12. doi: 10.1186/s40780-017-0081-z. eCollection 2017.
The accuracy, safety and feasibility of, the compounding robot APOTECAchemo were evaluated in the clinical practice of Japan.
Accuracy and precision of robotic preparations by APOTECAchemo was evaluated in 20 preparations of fluorouracil (FU) and cyclophosphamide (CPA) infusions by four pharmacists. Environmental and product contaminations with FU and CPA were evaluated by wipe testing. Robotic performance was compared with manual preparation in a biological safety cabinet. The number of robotic products, total compounding time and total pre-reconstitution time of lyophilized drugs between January 1, 2014 to December 31, 2015 were investigated.
Robotic preparation resulted more accurate and precise (mean absolute dose error and coefficient of variation were 0.83 and 1.04% for FU and 0.52 and 0.59% for CPA) than those of manual preparation (respective values were 1.20 and 1.46% for FU and 1.70 and 2.20% for CPA). Drug residue was not detected from any of the prepared infusion bags with the robotic preparation, whereas FU was detected in two of four analyzed infusion bags with manual preparation. Average total time to make single anticancer drug preparation (compounding plus reconstitution of lyophilized drugs) was 6.11 min in the second half of 2015. During the study period, the highest percentage of production covered by APOTECAchemo was 70.4% of the total inpatient pharmacy activity.
Robotic preparation using APOTECAchemo should give substantial advantages in drug compounding for accuracy and safety and was able to be successfully worked in Mie university hospital.
在日本的临床实践中评估了复方机器人APOTECAchemo的准确性、安全性和可行性。
由四名药剂师对APOTECAchemo进行的机器人制剂的准确性和精密度在20次氟尿嘧啶（FU）和环磷酰胺（CPA）输注制剂中进行了评估。通过擦拭测试评估了FU和CPA对环境和产品的污染情况。在生物安全柜中，将机器人操作性能与手工制剂进行了比较。调查了2014年1月1日至2015年12月31日期间机器人产品的数量、冻干药物的总配制时间和总复溶前时间。
机器人制剂比手工制剂更准确、精密（FU的平均绝对剂量误差和变异系数分别为0.83和1.04%，CPA分别为0.52和0.59%），手工制剂相应的值FU为1.20和1.46%，CPA为1.70和2.20%。机器人制剂的任何制备输液袋中均未检测到药物残留，而手工制剂的四个分析输液袋中有两个检测到FU。2015年下半年，制备单一抗癌药物制剂（配制加冻干药物复溶）的平均总时间为6.11分钟。在研究期间，APOTECAchemo覆盖的最高生产百分比为住院药房总活动的70.4%。
使用APOTECAchemo进行机器人制剂在药物配制的准确性和安全性方面应具有显著优势，并且能够在三重大学医院成功运行。
