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Michael N. Neuss, MD, Martha Polovich, PhD, RN, AOCN®, Kristen McNiff, MPH,
Peg Esper, MSN, RN, ANP-BC, AOCN®, Terry R. Gilmore, RN,
Kristine B. LeFebvre, MSN, RN, AOCN®, Lisa Schulmeister, MN, APRN-BC, OCN®, FAAN,
and Joseph O. Jacobson, MD, MSc
Vanderbilt Ingram Cancer Center, Nashville TN, Duke Oncology Network, Durham, NC; University of Michigan Comprehensive
Cancer Center, Ann Arbor MI; American Society of Clinical Oncology, Alexandria, VA; Oncology Nursing Society, Pittsburgh, PA;
Oncology Nursing Consultant, New Orleans, LA; and Dana-Farber Cancer Institute, Boston, MA
In 2009, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) published standards for the
safe use of parenteral chemotherapy in the outpatient setting, including issues of practitioner orders, preparation, and administration
of medication. In 2011, these were updated to include inpatient facilities. In December 2011, a multistakeholder workgroup met
to address the issues associated with orally administered antineoplastics, under the leadership of ASCO and ONS. The workgroup
participants developed recommended standards, which were presented for public comment. Public comments informed final edits,
and the final standards were reviewed and approved by the ASCO and ONS Boards of Directors. Significant newly identified recom-
mendations include those associated with drug prescription and the necessity of ascertaining that prescriptions are filled. In addition,
the importance of patient and family education regarding administration schedules, exception procedures, disposal of unused oral
medication, and aspects of continuity of care across settings were identified. This article presents the newly developed standards.
Adherence The degree or extent of conformity to the provider’s recommendations about day-to-day treatment with
respect to timing, dosing, and frequency (synonymous with compliance).
Chemotherapy All antineoplastic agents used to treat cancer, given through oral and parenteral routes or other routes as
specified in the standard. Types include targeted agents, alkylating agents, antimetabolites, plant alkaloids
and terpenoids, topoisomerase inhibitors, antitumor antibiotics, monoclonal antibodies, and biologics and
related agents. Hormonal therapies are not included in the definition of chemotherapy for the standards.
Chemotherapy regimen One or more chemotherapeutic agents used alone or in combination in a well-defined protocol, generally
administered cyclically.
Chemotherapy setting (site) All chemotherapy treatment settings (inpatient and outpatient).
Clinical encounter Clinical encounters include each inpatient day, practitioner visits, and chemotherapy administration visits,
but not laboratory or administrative visits.
Compliance The degree or extent of conformity to the provider’s recommendations about day-to-day treatment with
respect to timing, dosing, and frequency (synonymous with adherence).
Persistence The ability of a person to continue to take medication over the prescribed and chronic course of an illness,
including getting and taking refills on initial prescriptions, often reflecting education.
Practitioner Licensed independent practitioner, including physicians, advanced practice nurses (nurse practitioner or
clinical nurse specialist), and/or physician assistants, as determined by state law.
Table 2. Summary of Changes and Additions to the 2011 ASCO/ONS Chemotherapy Administration Safety
Standards
2011 2013
Standard Changes Public Comment (% “yes” responses rounded down) Standards
New Proposed fertility discussion/pregnancy 91%—Split into two standards; pregnancy screening added to 2C and 18D
screening 2C and fertility education added to 18D.
New Proposed assessment of barriers before 86%—Proposed standard revised on the basis of comments. 2I
initiation of oral chemotherapy
New Proposed standard addressing drug storage 96%—Minimal edits made on the basis of comments. 8
New Proposed items to include in a prescription 92%—Proposed standards revised on the basis of comments. 12
for oral chemotherapy
New Proposed communication for discontinua- 91%—Minimal edits made based on comments. 14
tion of oral chemotherapy
New Proposed standard to document patient 80%—Comments raised concerns about the ability to measure 18
engagement engagement. Dropped as a standard; concept incorporated
into existing standard.
15 Proposed additions to patient education 98%—Revised to reflect specific needs of oral chemotherapy. 20
materials.
18 Proposed verification of IV pump rate if 88%—Edited language to improve clarity and the ability to 21B
applicable. assess.
New Proposed assessment of adherence to oral 87%—Considerations raised in public comment were discussed 25
chemotherapy at the workshop. Changed from policy to process in place.
New Proposed medication reconciliation and 90%—Minor edits from workshop discussion and comments. 27
drug-drug interaction analysis at each clini- Revised existing standard.
cal encounter.
25 Proposed addition of “monitoring visits” to 91%—Proposed change not made, as the standard incorporates 25
existing standards. all types of visits.
27 Proposed changes to enhance communi- 87%—Edited current standard for clarity in response to public 31
cation comment.
• Verification that the patient understands how to take the 30. The practice/institution evaluates and documents treatment-
prescribed oral chemotherapy (eg, frequency, with/without related toxicities using standard definitions or criteria selected
food, whole or crushed, etc) by that practice/institution.
• Verification that the patient understands what to do in case Examples include NCI Common Toxicity Criteria and WHO
of missed doses Toxicity Criteria.
• Assessment for potential toxicity 31. The practice/institution has policies and procedures that identify:
26. On each clinical visit or day of treatment during chemotherapy A. A process to provide 24/7 triage to a practitioner (eg,
administration, staff: on-call practitioner, emergency department) for care of
A. Assess and document clinical status and/or performance toxicities
status B. Consistent documentation and communication of toxici-
B. Document vital signs and weight ties, modifications in dose or schedule, or discontinuation
of treatment, within the practice/institution
C. Verify allergies, previous reactions, and treatment-related
toxicities 32. The practice/institution has a system in place to promote a
safe handoff between all sites of care, including evaluating
D. Assess and document psychosocial concerns and need for and communicating appropriateness of, and schedule for,
support, taking action when indicated chemotherapy administration in another setting.
This standard applies to all clinical encounters (including each 33. Toxicity assessment documentation is available for planning
inpatient day, practitioner visits, and chemotherapy admin- subsequent treatment cycles.
istration visits, but not laboratory or administrative visits).
34. The practice/institution has a process to track cumulative doses
27. At each clinical encounter, staff review and document the of chemotherapy agents associated with a risk of cumulative
patient’s current medications, including over-the-counter toxicity.
medications and complementary and alternative therapies.
35. The practice/institution maintains a plan for ongoing and reg-
Any change in the patient’s medications prompts a review for
imen-specific assessment of each patient’s oral chemotherapy
drug-drug interactions.
adherence and toxicity. The policy includes, at minimum,
This standard applies to all clinical encounters (including each patient assessment for adherence and toxicity at each clinical
inpatient day, practitioner visits, and chemotherapy administra- encounter at the practice/institution, as well as a plan for clini-
tion visits, but not laboratory or administrative visits). cal staff to address any issues identified.
28. The practice/institution maintains referral resources for psycho- 36. The practice/institution uses standard, disease-specific pro-
social and other supportive care services. cesses to monitor treatment response (eg., use of evaluations,
29. The practice/institution has a procedure for documentation laboratory results, or scans/imaging) that are based on pub-
and follow-up for patients who miss or cancel scheduled visits lished literature/guidelines or are determined by the practice/
and/or chemotherapy treatments. institution.
NOTE. The current version of these consensus standards reflects modifications that are intended to extend the standards to address the
safe use of oral chemotherapeutic agents. The American Society of Clinical Oncology/Oncology Nursing Society (ASCO/ONS) standards
are intended to reflect current thinking on best practices and, as such, are intended to be a “living” document; future modifications are
expected.
Although the ASCO/ONS standards were not developed to address this issue, ASCO and ONS endorse the safe handling of chemotherapy
agents. Published guidelines define the expectations for organizations and health care workers related to the use of safe handling precautions
(American Society of Health System Pharmacists: Am J Health Syst Pharm 63:1172-1193, 2006; National Institute for Occupational Safety
and Health: DHHS publication No. 2004-165, 2004; Occupational Safety and Health Administration: OSHA technical manual, 1995;
Polovich M et al: Pittsburgh, PA, Oncology Nursing Society, 2009; US Pharmacopeial Convention, Rockville, MD, 2008). Education, train-
ing, and competency validation for chemotherapy administration must necessarily include this aspect of practice. Organizations should
focus on a culture of safety, because of the relationship between patient and health care worker safety (Friese CR et al: BMJ Qual Saf,
2011; Polovich M, Clark PC: Oncology Nursing Forum, 2012).
The standards are not deemed comprehensive and do not account for individual patient variation. It is the responsibility of each admin-
istering agent to determine the best methods for chemotherapy administration for each patient. The standards are not medical advice or
legal advice. To the extent that the standards conflict with applicable federal, state, or local legal requirements, practitioners should comply
with those requirements. The administering agent is solely responsibile for, and assumes all risks of, administering chemotherapy drugs
notwithstanding any adherence to the standards herein. ASCO and ONS disclaim any and all liability with respect to the standards and
the execution of the standards by any party.
Abbreviations: DOB, date of birth; NCI, National Cancer Institute; NP, nurse practitioner; RN, registered nurse.
to their implementation, including (but not limited to) oral chemotherapy. For a variety of reasons, copay-
issues of drug handling such as storage and disposal, ments and other costs to patients may be greater for
as well as the provenance of drugs provided to patients oral as opposed to parenteral therapies. In addition,
through varied procedures, pathways, and pharmacies although a variety of state laws address this issue,17
which may be unknown to the prescribing physician. these high costs may serve as impediments to prescrib-
One such barrier is the high cost of oral agents and ing oral antineoplastic agents.18 Because medication
different reimbursement schedule for self-administered adherence is influenced by patient education, and
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