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Parenteral Chemotherapy Dose Rounding – Adult/Pediatric – Inpatient/Ambulatory

Parenteral Chemotherapy Dose Rounding – Adult/Pediatric – Inpatient/Ambulatory - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Clinical Practice Guidelines, Oncology


1
Parenteral Chemotherapy Dose
Rounding– Adult/Pediatric -
Inpatient/Ambulatory
Clinical Practice Guideline
Note: Active Table of Contents – Click to follow link
Table of Contents
EXECUTIVE SUMMARY ........................................................................................................... 3
SCOPE ...................................................................................................................................... 4
METHODOLOGY ...................................................................................................................... 5
DEFINITIONS ............................................................................................................................ 6
INTRODUCTION ....................................................................................................................... 6
RECOMMENDATIONS .............................................................................................................. 6
UW HEALTH IMPLEMENTATION ............................................................................................. 7
REFERENCES .......................................................................................................................... 8
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CPG Contact for Content:
Name: Mike Reed, RPh, BCOP, BCPS
Phone Number: (608) 821-1584
Email address: mreed@uwhealth.org

CPG Contact for Changes:
Name: Philip Trapskin, PharmD, BCPS
Phone Number: (608) 263-1328
Email Address: ptrapskin@uwhealth.org

Guideline Author(s):
Sara Koth, PharmD
Mary Mably, RPh, BCOP
Mike Reed, RPh, BCOP, BCPS

Coordinating Team Members:
Sara Koth, PharmD
Mary Mably, RPh, BCOP
Mike Reed, RPh, BCOP, BCPS

Review Individuals/Bodies:
Daniel Mulkerin, MD

Committee Approvals/Dates:
Pharmacy Oncology Service Line (Last Periodic Review: December 2013)
ξ Interim revision (June 2016)
Chemotherapy Review Council (Last Periodic Review: January 2014
ξ Interim revision (June 2016)

Release Date: July 2016 | Next Review Date: February 2017
















Copyright © 201� University of Wisconsin Hospital s and Clinics Authority
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3
Executive Summary
Guideline Overview
This clinical practice guideline is intended to guide the rounding of chemotherapy doses up or
down to the nearest vial size or a measurable unit to enhance the safety of injectable
chemotherapy preparation, dispensing administration, and to decrease the amount of wasted
chemotherapy. It is compiled from an extensive literature review of current evidence and
external clinical practice guidelines related to the rounding of chemotherapy doses.

Key Practice Recommendations
1. Clinical pharmacists who verify chemotherapy orders will have the ability to round
chemotherapy doses in the electronic medical record
2. Traditional cytotoxic chemotherapy agents will be rounded up or down, to the nearest vial
size or measurable unit, within 5% of the prescribed dose
3. Biologic chemotherapy agents will be rounded up or down, to the nearest vial size or
measurable unit, within 10% of the prescribed dose
4. Exemptions include research medications, medications included in research protocols,
radiotherapy agents, and medications that will be given intrathecally
5. Physicians may opt out of having the dose URXQGHG�DW�DQ\�WLPH�E\�LQGLFDWLQJ�³GR�QRW�PRGLI\�
SHU�SURWRFRO´�RU�RWKHU�HTXLYDOHQW�ZRUGLQJ�RQ�WKH�PHGLFDWLRQ�RUGHU

Companion Documents
Delegation protocol: Parenteral Chemotherapy Rounding ± Adult/Pediatric ±
Inpatient/Outpatient

Pertinent UW Health Policies & Procedures
UW Health Patient Care Policy 6.1.1 ± Chemotherapy Processes: Informed Consent, Ordering,
Verification, Administration, Documentation, and Patient/Family Education

Patient Resources
None





Copyright © 201� University of Wisconsin Hospital s and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 07/2016CCKM@uwhealth.org



4
Scope
Disease/Condition(s): Cancer, Graft Versus Host Disease (GVHD)

Clinical Specialty: Oncology, hematology, bone marrow transplant

Intended Users: Clinical pharmacists

Objective(s): To enhance the safety of chemotherapy preparation and administration, to
reduce the amount of wasted chemotherapy, and to reduce cost

Target Population: Adults and pediatric patients greater than or equal to five kilograms,
who receive cytotoxic and/or biologic chemotherapy agents for treatment of cancer.

Interventions and Practices Considered: The ordering, verification, and
preparation of chemotherapy products

Major Outcomes Considered: The safety of injectable chemotherapy preparation,
dispensing, and administration; the volume of and costs associated with wasted chemotherapy

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5
Methodology
Methods Used to Assess the Quality and Strength of the Evidence:
A modified Grading of Recommendations Assessment, Development and Evaluation (GRADE)
developed by the American Heart Association and American College of Cardiology (Figure 1.)
has been used to assess the Quality and Strength of the Evidence in this Clinical Practice
Guideline.1


Rating Scheme for the Strength of the Evidence:
Figure 1. Quality of Evidence and Strength of Recommendation Grading Matrix



.
Copyright © 201� University of Wisconsin Hospital s and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 07/2016CCKM@uwhealth.org



6
Definitions
1. Chemotherapy:
a. For the purpose of this guideline, chemotherapy will include all medications
designated by the P&T Committee as chemotherapy per Policy 6.1.1
Chemotherapy Processes: Informed Consent, Ordering, Verification,
Administration, Documentation, and Patient/Family Education unless otherwise
excluded in this guideline.

2. Cytotoxic chemotherapy:2
a. Cell-killing therapy, which interacts directly with DNA or its precursors so as to
inhibit the synthesis of new genetic material
b. Causes broad-based damage to DNA in both self and malignant cells
c. Conjugate agents are considered cytotoxic because of their cellular effects

3. Biologic chemotherapy:3
a. Treatment of cancer by use of living organisms, substances derived from living
organisms, or syntheticV�WKDW�WDNH�DGYDQWDJH�RI�WKH�LPPXQH�V\VWHP¶V�QDWXUDO�
ability to detect and kill cancer cells
b. Monoclonal antibodies, cytokines, therapeutic vaccines, viruses, gene therapy,
bacteria, and adoptive T-cell transfers

4. Safe Measurable unit:4
a. The smallest calibration on a syringe used to prepare the chemotherapy dose
Introduction
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there are limitations to this approach. Dosing based on BSA has not been found to consistently
be GLUHFWO\� FRUUHODWHG� ZLWK� D� SDWLHQW¶V� DELOLW\� WR� FOHDU� WKDW� PHGLFDWLRQ� Rr with therapeutic
outcomes. There are a variety of different formulas used to calculate BSA, and this dosing
method fails to take into account a variety of other patient-specific factors that may lead to
variability in drug distribution.5,6

The rounding of prescribed doses of chemotherapy agents up or down to the nearest vial size or
a safe measurable unit has been found to be associated with fewer calculation and measuring
errors and will therefore improve the safety of injectable chemotherapy prescribing, preparation,
dispensing, and administration. The rounding of chemotherapy doses has also been found to
lead to a reduction in drug waste by preventing the disposal of partially used vials during
preparation. Reduced waste is associated with decreased drug costs²both environmental and
monetary²related to the disposal of unused chemotherapy products.7-10

Evidence published to-date has found that outcomes in patients who receive dose-rounded
chemotherapy are not inferior to those who receive BSA-based dosing of chemotherapy.11-16
Recommendations
Practice Recommendations:
1. Clinical pharmacists who verify chemotherapy orders will have the ability to round
chemotherapy doses in the electronic medical record (Class I, Level A)
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7
2. Cytotoxic chemotherapy agents will be rounded up or down, to the nearest vial size or a
measurable unit, within 5% of the prescribed dose (Class I, Level A)
3. Biologic chemotherapy agents will be rounded up or down, to the nearest vial size or a
measurable unit, within 10% of the prescribed dose (Class I, Level A)
4. Supportive medications that are dosed relative to chemotherapy dosages will be
proportionately rounded (Class I, Level C)
5. Exemptions include research medications, medications included in research protocols,
radiotherapy agents, and medications that will be given intrathecally (Class I, Level C)
6. PhysLFLDQV�PD\�RSW�RXW�RI�KDYLQJ�WKH�GRVH�URXQGHG�DW�DQ\�WLPH�E\�LQGLFDWLQJ�³GR�QRW�
PRGLI\�SHU�SURWRFRO´�RU�RWKHU�HTXLYDOHQW�ZRUGLQJ�RQ�WKH�PHGLFDWLRQ�RUGHU (Class I, Level
A)

UW Health Implementation
Potential Benefits:
Benefits of guideline implementation include increased safety of chemotherapy dose
preparation, decreased waste of chemotherapy, and decreased costs associated with waste.

Potential Harms:
The potential harms of rounding doses of chemotherapy include increased toxicity or decreased
efficacy of the therapeutic agents.

Implementation Plan/Tools
This clinical practice guideline will be operationalized through a delegation protocol,
disseminated to clinical staff and posted electronically. This clinical practice guideline will be
posted on UConnect. A HealthLink functionality will also be created for ease and accuracy of
rounding.

Disclaimer
CPGs are described to assist clinicians by providing a framework for the evaluation and
treatment of patients. This Clinical Practice Guideline outlines the preferred approach
IRU�PRVW�SDWLHQWV��,W�LV�QRW�LQWHQGHG�WR�UHSODFH�D�FOLQLFLDQ¶V�MXGJPHQW�RU�WR�HVWDEOLVK�D�
protocol for all patients. It is understood that some patients will not fit the clinical
condition contemplated by a guideline and that a guideline will rarely establish the only
appropriate approach to a problem.

Copyright © 201� University of Wisconsin Hospital s and Clinics Authority
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References
1. Jacobs AK, Kushner FG, Ettinger SM, et al. ACCF/AHA clinical practice guideline
methodology summit report: a report of the American College of Cardiology
Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll
Cardiol. 2013;61(2):213-265.
2. Chabner BA. General principles of cancer chemotherapy. In: Brunton LB LJ, Parker KL,
ed. Goodman & Gilman's The Pharmacologic Basis of Therapeutics 11 ed. New York
NY: McGraw-Hill; 2005:607-629.
3. National Cancer Institute: Biological therapies for cancer.
http://www.cancer.gov/cancertopics/factsheet/Therapy/biological. Accessed January 30,
2014.
4. Olsen JLG, A.P.; Shrimpton, D.M.; Dillon, P. Syringes. In: Hall P, ed. Medical Dosage
Calculations. 9th ed2008:138-170.
5. Kaestner SA, Sewell GJ. Chemotherapy dosing part I: scientific basis for current practice
and use of body surface area. Clin Oncol (R Coll Radiol). 2007;19(1):23-37.
6. Kaestner SA, Sewell GJ. Chemotherapy dosing part II: alternative approaches and
future prospects. Clin Oncol (R Coll Radiol). 2007;19(2):99-107.
7. Gillian A. Toolkit: how to implement dose banding of chemotherapy 2008;
http://www.bopawebsite.org/contentimages/publications/Toolkit_Ver_3.0_FINAL.pdf.
Accessed June 23, 2013.
8. Fasola G, Aita M, Marini L, et al. Drug waste minimisation and cost-containment in
Medical Oncology: two-year results of a feasibility study. BMC Health Serv Res.
2008;8:70.
9. Field K, Zelenko A, Kosmider S, et al. Dose rounding of chemotherapy in colorectal
cancer: an analysis of clinician attitudes and the potential impact on treatment costs.
Asia Pac J Clin Oncol. 2010;6(3):203-209.
10. Winger BJ, Clements EA, DeYoung JL, et al. Cost savings from dose rounding of
biologic anticancer agents in adults. J Oncol Pharm Pract. 2011;17(3):246-251.
11. Chatelut E, White-Koning ML, Mathijssen RH, Puisset F, Baker SD, Sparreboom A.
Dose banding as an alternative to body surface area-based dosing of chemotherapeutic
agents. Br J Cancer. 2012;107(7):1100-1106.
12. Dooley MJ, Singh S, Michael M. Implications of dose rounding of chemotherapy to the
nearest vial size. Support Care Cancer. 2004;12(9):653-656.
13. Jenkins P, Wallis R. Dose-rounding of adjuvant chemotherapy for breast cancer: an
audit of toxicity. J Oncol Pharm Pract. 2010;16(4):251-255.
14. Johnson KB, Lee CK, Spooner SA, Davison CL, Helmke JS, Weinberg ST. Automated
dose-rounding recommendations for pediatric medications. Pediatrics.
2011;128(2):e422-428.
15. Plumridge RJ, Sewell GJ. Dose-banding of cytotoxic drugs: a new concept in cancer
chemotherapy. Am J Health Syst Pharm. 2001;58(18):1760-1764.
16. Smith DB. Clatterbridge Cancer Centre chemotherapy protocols. 2012;
http://www.clatterbridgecc.nhs.uk/document_uploads/Guidance/ChemotherapyProtocols
V10.0.pdf. . Accessed June 23, 2013.
Copyright © 201� University of Wisconsin Hospital s and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 07/2016CCKM@uwhealth.org