University of Minnesota Health, Maple Grove; Fairview Pharmacy Services, Minneapolis, MN; Spectrum Health Hospitals, Grand Rapids, MI; Alaska Native Tribal Health Consortium, Anchorage, AK; The Johns Hopkins Hospital, Baltimore, MD; and Oregon Health and Science University Hospitals and Clinics, Portland, OR.
J Oncol Pract. 2018 Mar;14(3):e130-e136. doi: 10.1200/JOP.2017.025411. Epub 2018 Feb 5.
To present a position statement from the Hematology/Oncology Pharmacy Association (HOPA) that pertains to dose rounding of biologic and cytotoxic anticancer agents.
The HOPA Standards Committee organized a work group of oncology pharmacist specialists to examine the safety and value of dose rounding of biologic and cytotoxic anticancer agents. Primary literature that describes methods for dose rounding, with clinical or economic data, were analyzed. Relevant pharmacokinetic characteristics and aspects of product formulation were considered. Issues for institutional application were addressed.
Rounding of biologic and cytotoxic agents within 10% of the ordered dose is designated as acceptable for routine clinical care. Dose changes ≤ 10% are not expected to reduce the safety or effectiveness of therapy. The rounding amount-10%-is rational in the context of standard dose adjustments for patient tolerance and tumor response (≥ 20%), clinical trial deficiency criteria (> 10%), and the influence of interpatient pharmacokinetic variability. HOPA supports the use of the same threshold for dose rounding of anticancer drugs as that used for palliative and curative therapy. Potential exceptions to dose rounding are discussed.
Dose rounding reduces waste and health care costs. HOPA recommends that each institution develop its own dose-rounding policy that addresses biologic and cytotoxic agents. Institutional guidelines for dose rounding of anticancer agents, including criteria for automatic dose rounding, the allowable percentage, and institutional processes for operationalizing and documenting dose rounding, should be determined by collaborative stakeholder consensus. Exceptions to dose rounding should be determined a priori. Additional studies that evaluate the impact of dose rounding on patient outcome are warranted.
呈现一份来自血液病/肿瘤药学协会（HOPA）的立场声明，该声明涉及生物制剂和细胞毒性抗癌药物的剂量调整。
HOPA 标准委员会组织了一个肿瘤药师专家工作组，研究生物制剂和细胞毒性抗癌药物剂量调整的安全性和价值。分析了描述剂量调整方法的主要文献，包括临床或经济数据。考虑了相关的药代动力学特征和产品配方方面。解决了机构应用的问题。
将生物制剂和细胞毒性药物的剂量调整到医嘱剂量的 10%以内，被认为是常规临床护理的可接受范围。剂量变化≤10%预计不会降低治疗的安全性或有效性。在考虑到患者耐受性和肿瘤反应（≥20%）、临床试验缺陷标准（>10%）以及个体间药代动力学变异性的情况下，调整幅度为-10%是合理的。HOPA 支持将抗癌药物剂量调整的相同阈值用于姑息和根治治疗。讨论了剂量调整的潜在例外情况。
剂量调整可减少浪费和医疗保健成本。HOPA 建议每个机构制定自己的剂量调整政策，涵盖生物制剂和细胞毒性药物。应通过协作利益相关者的共识来确定抗癌药物剂量调整的机构指南，包括自动剂量调整、允许的百分比以及实施和记录剂量调整的机构流程。应事先确定剂量调整的例外情况。需要进行更多研究来评估剂量调整对患者结局的影响。
