Dose rounding of biologic and cytotoxic anticancer agents: A position statement of the hematology/oncology pharmacy association

Abstract

Purpose To present a position statement from the Hematology/Oncology Pharmacy Association (HOPA) that pertains to dose rounding of biologic and cytotoxic anticancer agents. Methods 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. Results 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. Conclusion 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.