[Preliminary study for the implementation of standardized rounded doses of cytotoxic druqs].

Journal de pharmacie de Belgique Pub Date : 2015-09-01
L Soumoy, C Pirlot, C Decoster, P Gillet, J D Hecq
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Abstract

Background: "Dose-banding" is a concept of cytotoxic drugs standardization allowing the preparation in advance of standardized rounded doses (SRD covering the most frequently prescribed doses rounded to +/-5%. Standard doses will be prepared in advance by batch in order to increase production capacity and at the same time to regulate pharmacy workflow as well as to reduce patient waiting time.

Purpose: To identify anticancer drugs suitable for dose banding and to fix standardized doses.

Methods: The interesting molecules are first selected in accordance with several criteria: preparations frequency, long-term physicochemical stability after reconstitution, repetition of the prescribed doses and savings opportunity. The selected molecules were: Carboplatin, Cetuximab, Cisplatin, Cyclophosphamide, Doxorubicin, 5-Fluorouracil, Gemcitabine, Oxaliplatine, Paclitaxel, Rituximab, Trastuzumab and Vinorelbine. We established an inventory of the prescriptions retrospectively for a period of six months in order to highlight the most often prescribed doses. For the analysis, we fixed bands with a standard deviation of +/- 5%, 7% and +/- 10%.

Results: Standardization of doses of chemotherapy was deemed interesting if > or =60% of the doses were standardisable with a maximum of five SRD and a minimum of one delivery per week, in order to guarantee a good turnover of the batch. A maximum of 5% standard deviation is added to those three criteria, the deviation currently accepted among our medical staff. After analyzing 3506 prescriptions, 7 molecules are eligible: Doxorubicine, 5-Fluorouracil infusion, 5-Fluorouracil pump, Gemcitabine, Paclitaxel, Rituximab, Trastuzumab and Vinorelbine, with a percentage of standardisation of 77% [SRD: 30 mg), 61% [SRD: 700 mg, 750 mg, 800 mgl, 75% (SRD: 4000 mg, 4500 mg, 5000 mg), 72% [SRD: 1600 mg, 1800 mg, 2000 mg), 61% [SRD: 140 mg, 150 mg, 160 mgl, 64% (SRD: 600 mg, 700 mg, 750 mg], 71% (SRD: 350 mg, 400 mg. 450 mgl et 62% [SRD: 40 mg, 50 mg] respectively.

Conclusion: This preliminary study allows us to consider implementing the dose banding concept in order to optimize the chemotherapy circuit at our institution.

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[实施细胞毒性药物标准四舍五入剂量的初步研究]。
背景:“剂量带”是细胞毒性药物标准化的一个概念,允许提前准备标准化的四舍五入剂量(SRD),其中包括最常用的四舍五入至+/-5%的处方剂量。标准剂量将按批次提前配制,以增加生产能力,同时规范药房工作流程并减少患者等待时间。目的:确定适合剂量带的抗癌药物,并确定标准剂量。方法:首先根据制备频率、重构后的长期理化稳定性、处方剂量的重复和保存机会等标准选择感兴趣的分子。选择的分子有:卡铂、西妥昔单抗、顺铂、环磷酰胺、阿霉素、5-氟尿嘧啶、吉西他滨、奥沙利铂、紫杉醇、利妥昔单抗、曲妥珠单抗和长春瑞滨。我们回顾性地建立了为期6个月的处方清单,以突出显示最常用的处方剂量。为了进行分析,我们固定了标准偏差为+/- 5%,7%和+/- 10%的波段。结果:如果≥60%的剂量是标准化的,最多5次SRD,每周至少一次递送,以保证批次的良好周转,则认为化疗剂量的标准化是有意义的。这三个标准的最大标准偏差为5%,这是我们医务人员目前接受的偏差。通过对3506张处方的分析,确定了7个分子:阿霉素、5-氟尿嘧啶输注、5-氟尿嘧啶泵、吉西他滨、紫杉醇、利妥昔单抗、曲妥珠单抗和维诺瑞滨,标准化比例为77% [SRD: 30 mg]、61% [SRD: 700 mg、750 mg、800 mg、75% (SRD: 4000 mg、4500 mg、5000 mg)、72% [SRD: 1600 mg、1800 mg、2000 mg)、61% [SRD: 140 mg、150 mg、160 mg、64% (SRD: 600 mg、700 mg、750 mg)、71% (SRD: 350 mg、400 mg)。450毫克和62% [SRD: 40毫克,50毫克]。结论:这项初步研究使我们可以考虑实施剂量带概念,以优化我们机构的化疗回路。
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