Milibari Loay, Cotugno Michael, Belisle Caryn, Rocchio Megan, Patterson Robert F, Chacon Pablo, Fanikos John, Vo Peter
Pharmacy Department, Brigham and Women's Hospital, Boston, Massachusetts.
Int J Pharm Compd. 2020 Jul-Aug;24(4):346-351.
The compounding of sterile medication admixtures is a labor-intensive process and subject to potential human error. The addition of robotic devices and workflow technology may mitigate some of the challenges of compounding sterile product admixtures, especially for those associated with antineoplastic and hazardous medications. This article discusses the single-center experiences from October 2009 through August 2017 with various sterile compounding robotic technologies. The robotic devices included Intellifill i.v., Cytocare, i.v.Station, i.v.Station ONCO, and i.v.Soft Assist. The objective of this analysis was to describe the experience with robotic technology and workflow devices in compounding sterile medication admixtures. The number of prepared doses for each device was tracked, and each device had a tool to validate the dose accuracy via specific gravity measurement. Nonhazardous preparations with a dose variation of > (+/- 10%) were considered failures. For hazardous medications, variation of > (+/- 5%) was considered a failure. Doses that were prepared manually were also analyzed. The Intellifill i.v. robot was used to compound more than 1,000,000 admixtures (75% of all compounded products). The i.v.Station, Cytocare, i.v.Station ONCO, and i.v.Soft Assist robots compounded 14%, 7%, 3%, and 0.7% of the total chemotherapy doses required. Identified barriers to optimal performance included device (hardware) and software failures as well as shortages with specific fluid and drug containers. The qualitative analysis was done for 36 drugs that were prepared using i.v.Station and i.v.Station ONCO. The passing rate was estimated to be 95%. Barriers to use the device included lack of the appropriate medication container, diluent supplies issues, and software failure. Robotic devices and workflow technology for compounding sterile medication admixtures were unable to produce all routine parenteral doses required daily.
无菌药物混合制剂的配制是一个劳动密集型过程，且存在人为失误的可能性。引入机器人设备和工作流程技术可能会缓解配制无菌产品混合制剂时面临的一些挑战，尤其是与抗肿瘤和危险药物相关的挑战。本文讨论了2009年10月至2017年8月期间使用各种无菌配制机器人技术的单中心经验。机器人设备包括Intellifill i.v.、Cytocare、i.v.Station、i.v.Station ONCO和i.v.Soft Assist。本分析的目的是描述在配制无菌药物混合制剂时使用机器人技术和工作流程设备的经验。记录了每个设备配制的剂量数量，每个设备都有通过比重测量来验证剂量准确性的工具。剂量变化>（+/- 10%）的非危险制剂被视为失败。对于危险药物，变化>（+/- 5%）被视为失败。还对手动配制的剂量进行了分析。Intellifill i.v.机器人用于配制超过100万剂混合制剂（占所有配制产品的75%）。i.v.Station、Cytocare、i.v.Station ONCO和i.v.Soft Assist机器人分别配制了所需化疗总剂量的14%、7%、3%和0.7%。已确定的影响最佳性能的障碍包括设备（硬件）和软件故障以及特定液体和药物容器短缺。对使用i.v.Station和i.v.Station ONCO配制的36种药物进行了定性分析。通过率估计为95%。使用该设备的障碍包括缺乏合适的药物容器、稀释剂供应问题和软件故障。用于配制无菌药物混合制剂时的机器人设备和工作流程技术无法生产出每日所需的所有常规肠外剂量。
