Dose Rounding of Anticancer Agents: Hematology/Oncology Pharmacy Association Position Statement
As reported in the Journal of Oncology Practice by Fahrenbruch et al, the Hematology/Oncology Pharmacy Association (HOPA) has issued a position statement on dose rounding of biologic and cytotoxic anticancer agents.
To formulate the position statement, the HOPA standards committee organized a work group of oncology pharmacist specialists to assess safety and value of dose rounding of anticancer agents, including analysis of primary literature on methods for dose rounding and clinical or economic data. Pharmacokinetic characteristics and factors in product formulation were considered in developing the statement. Key elements of the statement are summarized/reproduced below.
Key Elements
- 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 of 10% is rational in the context of standard dose adjustments for patient tolerance and tumor response (≥ 20%), clinical trial deficiency criteria (> 10%; ie, according to National Cancer Institute guidelines, variance from protocol-specified procedures that result in dose deviations or modifications to this threshold), and influence of inter-patient 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. For example, patients with major organ dysfunction, poor performance status, extensive treatment history, enzyme deficiencies, or genetic polymorphisms may not be suitable candidates for rounding up doses, since even small adjustments could result in pharmacokinetic or pharmacodynamic changes that increase risk for serious adverse events.
The authors concluded, “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.”
Rebecca Fahrenbruch, PharmD, of Fairview Pharmacy Services, Maple Grove, Minnesota, is the corresponding author for the Journal of Oncology Practice article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
