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[教学医院抗癌药物批量制备流程的实施与评估]

[Implementation and assessment of anticancer drugs batch preparation circuit in a teaching hospital].

作者信息

Moine M, Hachon L, Sankhare D, Ade A, Madelaine I, Jourdan N

机构信息

Hôpital Saint-Louis, AP-HP, 75010 Paris, France.

Hôpital Saint-Louis, AP-HP, 75010 Paris, France.

出版信息

Ann Pharm Fr. 2018 Jul;76(4):306-320. doi: 10.1016/j.pharma.2018.03.001. Epub 2018 Apr 4.

DOI:10.1016/j.pharma.2018.03.001
PMID:29625693
Abstract

INTRODUCTION

In 2011, the anticancer preparation unit in a teaching hospital implemented a circuit for batch preparation of anticancer drugs. In this circuit, a manual and a semi-automatic production process coexist. The aim of the study is to describe the circuit in 2016 and to assess the impact of batch preparation in a anticancer preparation unit.

MATERIAL AND METHODS

Eligible anticancer drugs for batch preparation satisfy two conditions: solution stability up to 28 days, prescription frequency up to one every two days. Batch worksheets are standardized. The pharmaceutical validation relies on the conformity of microbiological, analytical, gravimetric and visual controls of infusion bags. The duration of manual and semi-automatic batch preparation process and the time availability of an infusion bag were assessed.

RESULTS

In 2016, eleven anticancer drugs (33 dosages) were eligible for batch preparation: it represents 22% of total production. In total, 70% was semi-automatic. The mean batch sizes were 27±9 (semi-automatic) and 14±1 (manual). The mean duration of production process was respectively 78min and 113min for semi-automatic and manual batch preparation. The mean time availability of an infusion bag was 32min±17.

DISCUSSION AND CONCLUSION

Our process is secure. Batch preparation of anticancer drugs contributes to smooth production and spare nurses from preparing infusion bags outside opening hours of the anticancer preparation unit. Eligible anticancer drugs and batches size change constantly according to the evolution of prescription frequencies and anticancer drugs public tenders.

摘要

引言

2011年,一家教学医院的抗癌制剂部门实施了抗癌药物批量制备流程。在该流程中,手动和半自动生产过程并存。本研究的目的是描述2016年的该流程,并评估抗癌制剂部门批量制备的影响。

材料与方法

适合批量制备的抗癌药物需满足两个条件:溶液稳定性达28天,处方频率每两天最多一次。批量制备工作表实现标准化。药物验证依赖于输液袋微生物、分析、重量和外观检查的合规性。评估了手动和半自动批量制备过程的持续时间以及输液袋的可用时间。

结果

2016年,11种抗癌药物(33种剂型)适合批量制备:占总产量的22%。总体而言,70%为半自动制备。半自动和手动制备的平均批量分别为27±9和14±1。半自动和手动批量制备的平均生产过程持续时间分别为78分钟和113分钟。输液袋的平均可用时间为32分钟±17分钟。

讨论与结论

我们的流程是安全的。抗癌药物的批量制备有助于生产顺利进行,并使护士无需在抗癌制剂部门开放时间之外准备输液袋。符合条件的抗癌药物和批量大小会根据处方频率的变化和抗癌药物公开招标情况不断变化。

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