技术辅助与手动无菌配制对加拿大社区医院安全性和效率的影响。

Impact of technology-assisted versus manual sterile compounding on safety and efficiency in a Canadian community hospital.

机构信息

Centre for Research and Innovation, North York General Hospital, Toronto, ON, Canada.

Department of Pharmacy, North York General Hospital, Toronto, ON, Canada.

出版信息

Am J Health Syst Pharm. 2022 Sep 22;79(19):1685-1696. doi: 10.1093/ajhp/zxac167.

DOI:10.1093/ajhp/zxac167

PMID:35700925

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9494253/

Abstract

PURPOSE

Interventions to improve the safety and efficiency of manual sterile compounding are needed. This study evaluated the impact of a technology-assisted workflow system (TAWS) on sterile compounding safety (checks, traceability, and error detection), and efficiency (task time).

METHODS

Observations were conducted in an oncology pharmacy transitioning from a manual to a TAWS process for sterile compounding. Process maps were generated to compare manual and TAWS checks and traceability. The numbers and types of errors detected were collected, and task times were observed directly or via TAWS data logs.

RESULTS

Analysis of safety outcomes showed that, depending on preparation type, 3 to 4 product checks occurred in the manual process, compared to 6 to 10 checks with TAWS use. TAWS checks (barcoding and gravimetric verification) produced better traceability (documentation). The rate of incorrect-drug errors decreased with technology-assisted compounding (from 0.4% [5 of 1,350 preparations] with the manual process to 0% [0 of 1,565 preparations] with TAWS use; P < 0.02). The TAWS increased detection of (1) errors in the amount of drug withdrawn from vials (manual vs TAWS, 0.4% [5/1,350] vs 1.2% [18/1565]; P < 0.02), and (2) errors in the amount of drug injected into the final container (manual vs TAWS, 0% [0/1,236] vs 0.9% [11/1,272]; P < 0.002). With regard to efficiency outcomes, TAWS use increased the mean mixing time (manual vs TAWS, 275 seconds vs 355 seconds; P < 0.001), had no significant impact on average visual checking time (manual vs TAWS, 21.4 seconds vs 21.6 seconds), and decreased average physical checking time (manual vs TAWS, 58.6 seconds vs 50.9 seconds; P < 0.001).

CONCLUSION

In comparison to manual sterile compounding, use of the TAWS improved safety through more frequent and rigorous checks, improved traceability (via superior documentation), and enhanced error detection. Results related to efficiency were mixed.

摘要

目的

需要采取干预措施来提高手动无菌调配的安全性和效率。本研究评估了技术辅助工作流程系统（TAWS）对无菌调配安全性（检查、可追溯性和错误检测）和效率（任务时间）的影响。

方法

在一家从手动到 TAWS 无菌调配过程的肿瘤药房进行观察。生成流程图以比较手动和 TAWS 检查和可追溯性。收集检测到的错误数量和类型，并直接或通过 TAWS 数据日志观察任务时间。

结果

对安全性结果的分析表明，根据制剂类型，手动过程中进行了 3 到 4 次产品检查，而使用 TAWS 时则进行了 6 到 10 次检查。TAWS 检查（条形码和重量验证）产生了更好的可追溯性（文档记录）。随着技术辅助调配的使用，错误用药的发生率降低（从手动过程的 0.4%（1350 个制剂中的 5 个）降至 0%（TAWS 时的 1565 个制剂中的 0 个）；P<0.02）。TAWS 增加了对以下方面错误的检测：（1）从小瓶中取出的药物量错误（手动与 TAWS，0.4%（5/1350）与 1.2%（18/1565）；P<0.02）；（2）注射到最终容器中的药物量错误（手动与 TAWS，0%（0/1236）与 0.9%（11/1272）；P<0.002）。关于效率结果，TAWS 的使用增加了混合时间的平均值（手动与 TAWS，275 秒与 355 秒；P<0.001），对平均目视检查时间没有显著影响（手动与 TAWS，21.4 秒与 21.6 秒），并减少了平均物理检查时间（手动与 TAWS，58.6 秒与 50.9 秒；P<0.001）。