Antineoplastic Therapy Administration Safety Standards for Adult and Pediatric Oncology: ASCO-ONS Standards

The purpose of these standards is to update the 2016 Updated American Society of Clinical Oncology (ASCO)/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.^1-5

Over the past 15 years, ASCO and ONS have collaborated to create and reassess standards for the administration of antineoplastic therapy to maximize safety for patients with cancer and to minimize inadvertent but preventable harms with this potentially toxic set of compounds.^1,3-6 In 2016, the respective organizations last published updates of these standards; that version explicitly included the pediatric population as does this version.

These standards have been fundamental principles of the two organizations, and a variety of quality programs including ASCO’s Quality Oncology Practice Initiative and its certification programs have included selected standards⁷ and will be discussed for incorporation in the new ASCO Certified Patient-Centered Cancer Care Standards. These standards focus on the requisite training of individuals involved with the provision of these medications as well as the preparation, labeling, and ultimately the administration of therapy at home⁸ or in a health care facility. They are a blueprint for optimizing and standardizing the various steps in the process where medical errors can occur.⁹ These standards attempt to inoculate the process against such errors by creating a foundation of consistent interactions and eliminate an environment of operational variability in which medical errors often thrive in the absence of a standardized protocol-driven approach.¹⁰ Despite the focus on eliminating variability, standards that do not change with time or reflect the most current literature and evidence may become obsolete. This is most evident in the change of the fundamental terminology in these standards from chemotherapy to antineoplastic therapy. Since the last major standards update in 2016, there has been a profusion of new drugs and approaches to cancer care including, but not limited to, a variety of genomically determined targeted therapies (largely oral), immunomodulatory agents, bispecific T-cell engagers, and chimeric antigen receptor T-cell antigen therapy, all of which are now mentioned in the standards. Finally, where the administration of antineoplastic therapy had historically been performed either in the hospital setting or in physicians’ offices or clinics, it is now not uncommon for treatment to be administered in the home¹¹ or in a freestanding center to which the ordering physician has no relationship. Conversely, because of a variety of insurance and pharmacy benefit-related requirements, clinics are now occasionally the recipients of pharmaceuticals prepared elsewhere by individuals, not under their employ, for local administration. These standards highlight the relative responsibilities of all parties in these progressively more complicated relationships.

The fundamental reason for publishing these new standards is that despite medical oncology’s supporting technology and its evolving sophistication as a science, patient care mistakes and medication errors still happen,^9,12 usually for very simple and very human errors of omission and commission. Attention to the details of operational processes will optimize care and patient safety. The COVID-19 pandemic caused a rather significant disruption in oncology staffing models with resultant high turnover, leaving treatment centers with less experienced and less knowledgeable individuals responsible for the ordering, preparation, and administration of these antineoplastics.^13-17 Updating the standards will provide newer providers with the most up-to-date approaches.

Research Questions

Overarching Research Question

What are standards for ordering, preparing, dispensing, and administering antineoplastic therapy?

These standards address seven overarching research questions across four domains.

Domain 1: Creating a Safe Environment

Research Question 1: Does the care provided by oncology professionals who meet certain qualifications result in fewer medical errors and reduce preventable harm, compared with those who do not?

Research Question 1.1: Does the care provided by health care organization that have specific quality improvement or standardization of care policies in place result in fewer medical errors and reduce preventable harm compared with no or less specific policies?

Research Question 2: Do documentation policies mandated and/or implemented by health care organizations result in fewer medical errors and reduce preventable harm compared with no documentation policies?

Domain 2: Patient Consent and Patient Education

Research Question 3: Do policies on treatment planning, patient consent, and patients’ education result in fewer medical errors and reduce preventable harm, compared with those who do not?

Domain 3: Ordering, Preparing, Dispensing, and Administering Oral and Parenteral Antineoplastic Therapies in a Health Care Facility, Organization, or the Home

Research Question 4: Do policies on ordering, preparing, dispensing, and administering antineoplastic therapy result in fewer medical errors and reduce preventable harm, compared with no or less specific policies?

Research Question 5: Do policies on ordering, preparing, dispensing, and administering antineoplastic therapy for patients at home result in fewer medical errors, reduce preventable harm, and increase adherence, compared with no or less specific policies?

Research Question 6: Do policies on ordering, preparing, dispensing, and administering antineoplastic therapy intrathecally or intraventricularly for patients result in fewer medical errors and reduce preventable harm, compared with those who do not?

Domain 4: Monitoring During and After Antineoplastic Therapy Is Administered, Including Adherence, Toxicity, and Complications

Research Question 7: Do policies on post-treatment monitoring of adverse events from antineoplastic therapy result in fewer medical errors and reduce preventable harm, compared with no or less specific policies?

Methods

Standards Development Process

These systematic review-based standards were developed by a multidisciplinary Expert Panel, which included physicians, nurses, pharmacists, experts in treatment of both adult and pediatric patients, a patient representative, and an ASCO staff member with health research methodology expertise (Appendix Table A1)

The standards statements were developed by using a systematic review of evidence identified through online searches of PubMed (January 2015 to January 2023) and CINAHL (January 2015 to April 2023) of systematic reviews, guidelines, best practice statements, interventional trials, observational studies, and clinical experience. Articles were selected for inclusion in the systematic review on the basis of the following criteria:

• Population: Adults, adolescents and young adults, and children with cancer, caregivers of patients with cancer
• Interventions: Antineoplastic protocols or policy and/or documentation policies, education interventions, technological interventions, documentation
• Comparisons: No or less specific policies
• Outcomes: Accidents, medical errors, patient harm, adverse events, adverse drug interventions, adherence, death, hospital admittance.

Articles were excluded from the systematic review if they were (1) meeting abstracts; (2) editorials, commentaries, letters, news articles, and narrative reviews; (3) non-English language; and (4) case series examining errors in low–/ middle–human development index countries with <50 patient treatments per month.

Three full panel meetings were held, and members were asked to provide ongoing input on the standards development protocol, quality and assessment of the evidence, generation of statements, and draft content and review and approve drafts during the entire development of the standards. ASCO and ONS staff met routinely with the Expert Panel co-chairs and corresponded with the panel via e-mail to coordinate the process to completion. All funding for the administration of the project was provided by ASCO.

Standards Review and Approval

The draft statements were released to the public for open comment from September 28, 2023, through October 18, 2023. Response categories of “Agree as written,” “Agree with suggested modifications,” and “Disagree. See comments” were captured for every proposed statement with 82 written comments received. A total of 71%-100% of the 82 responses either agreed or agreed with slight modifications to the statements, and 14%-29% of the responses disagreed (primarily on the reorganized Domain 3). For 25 of the standards, there was no disagreement. Expert Panel members reviewed comments from all sources and determined whether to maintain original draft statements, revise with minor language changes, or consider major revisions.

All changes were incorporated into the final manuscript before ASCO Evidence-Based Medicine Committee (EBMC) and ONS Board of Directors review and approval. All ASCO-ONS standards are ultimately reviewed and approved by the Expert Panel and the ASCO EBMC and ONS Board of Directors before submission to the Journal of Clinical Oncology (JCO) Oncology Practice for editorial review and consideration for publication.

Standards Updating

The ASCO Expert Panel and staff will work with co-chairs to keep abreast of any substantive updates to the standards. On the basis of formal review of the emerging literature, ASCO will determine the need to update. The ASCO Standards Policies and Procedures Manual (available at http:// www.asco.org/standards) provides additional information about the update process. This is the most recent information as of the publication date.

Results

Characteristics of Studies Identified in the Literature Search

A total of 5,248 publications were identified in the primary literature search. After applying the eligibility criteria for fulltext review, 227 publications remained, and the Expert Panel reviewed the results. The identified studies were published between 2015 and 2023. There were 10 RCTs, 17 systematic reviews, and 111 observational studies, and the remainder were organizational policy statements and other noncomparative, nonprospective study types; few were found to be sufficiently relevant. At that point, the Expert Panel decided to use informal consensus, expert opinion, and publications suggested by Expert Panelists to form the basis for the standards. Terms within the standards have been defined in the accompanying Definitions of Terms (Appendix Table A2).

Standards

All standards for documentation and staff education are provided in Tables 1-3, patient consent education is given in Table 4; the ordering, preparing, dispensing, and administering antineoplastic therapy are listed in Tables 5-7, and post-treatment monitoring and adherence are presented in Table 8. Any new or revised standards are identified, and for these standards, the supporting literature review and interpretation are provided. Standards that did not require updating are considered current as of this publication, and the supporting literature review and interpretation are available in detail elsewhere.¹

Selected Standards—Key Changes and Additions

Domain 1: Safe Environment

Standard 1.2: The health care organization uses a comprehensive education program for initial and ongoing educational requirements for all staff who prepare and administer antineoplastic therapy.

Standard 1.5.3: Complete medical history and physical examination, including fertility status and pregnancy status, as applicable.

Standard 1.5.3.1: The health care organization has a policy for pregnancy testing prior to initiating antineoplastic therapies.

Standard 1.5.3.2: The health care organization has a policy for assessing risk of pregnancy in patients while receiving antineoplastic therapies.

Standard 1.5.3.3: The health care organization has a policy for determining a patient’s desire for ongoing or future fertility preservation prior to initiating antineoplastic therapy and making appropriate referrals when feasible.

Standard 1.5.8 (new): Initial and ongoing assessments of social determinants of health and barriers to care including financial and logistical constraints and supports needed to provide access to required medications (if applicable).

Standard 1.7: Weight and height are measured and documented in the medical record in metric units (eg, kg and cm). Both the measurement and documentation are verified by two individuals, one of whom is a licensed clinician, prior to preparation and administration of a newly prescribed antineoplastic treatment plan. The measurement is repeated when clinically appropriate as determined by the policy of the health care organization.

Standard 1.16 (new): The The health care organization uses an electronic medical record (EMR) ordering format for antineoplastic therapy, when feasible.

Literature review update results and interpretation. For Standard 1.2, no randomized trials were identified by the systematic review. One observational study was identified.¹⁸ The Expert Panel opted to make this minor change to simplify the standard language and define the elements of a comprehensive education program in the glossary.

Regarding pregnancy, a standard for fertility preservation was not specifically mentioned under documentation before the first administration of antineoplastic therapy and therefore was added here. Clinicians should address fertility preservation for appropriate patients prior to first administration and ensure education is provided on potential long-term and short-term infertility risks. Standard 2.3.5 further discusses fertility preservation.¹⁹

An environmental scan of the literature showed a paucity of literature on pregnancy and cancer treatment²⁰; anecdotal information suggests some patients remain at risk of pregnancy or contributing to pregnancy, during antineoplastic treatment. Management options may differ where restriction depends on US state and geography.²¹ Despite opportunities to identify pregnancy earlier in the process, if they are missed, the opportunities before administration of antineoplastic therapy are a key point to prevent the potentially negative sequelae of antineoplastic therapy to patients who are pregnant. Pregnancy status is usually discussed in the context of treatment planning and/or ordering. Each health care organization should define the details of its specific policies (see also Standard 2.3.6. on education.) ASCO is currently developing a systematic review-based guideline on pregnancy in patients with cancer. Finally, sexual health is also an important area of discussion.^22,23

Social determinants of health, defined by the WHO as the conditions in which an individual is born, grows, lives, works, and ages, can undermine ASCO and ONS expert guidance on best practices for prevention, screening, palliative and supportive care, and disease management for many patients with cancer.²⁴ One study regarding financial toxicity was found to inform this standard that met the criteria for the systematic review, a prospective study of in-office dispensing of oral therapy.²⁵ Expert Panel members also suggested inclusion of the following studies regarding financial toxicity^26,27 and added this standard to the list of the elements that need to occur before the first administration of a new antineoplastic therapy regimen (starting with Standard 1.5) due to the potential risks of this toxicity to patients and caregivers. ASCO provides further resources on financial toxicity at Cancer.Net²⁸ (see also Standard 4.6.)

Anecdotal concerns about accuracy of height and weight measurement prompted a supplemental literature search, identifying 12 studies that addressed the topic. In a study of 10,000 randomly selected medical records, authors found errors in 20% of medical records, reflecting clearly mistyped numbers, single-digit errors, decimal misplacement, number transposition, and documentation of pounds rather than kilograms.29 Errors occurring in measurement, transcription, and documentation were most prevalent.^29-32 To minimize errors in weight and height–based dosing, the Institute of Safe Medical Practices³³ recommends consistent procedures for height and weight measurement, when measured in metric units only. Prior to the start of a new treatment plan, consistent methodology and verification of height and weight by two clinicians, one of which is licensed, have been added to the standards to decrease the risk of documentation error.

The frequency of weight measurement was specifically evaluated in a review of 23 additional studies. Other authors found that a change in body surface area of 10% or greater occurred in 7.6% of patients on active treatment and that weight checks with each visit or cycle were not necessary.³⁴ However, weight has been studied as an indicator of nutritional status and overall survival in many cancer types.^35-37 The Expert Panel determined that the frequency of measurement of both height and weight after starting a new treatment plan should be based on health care organization policy and reflect the patient population (eg, patient age, diagnosis) and treatment type. Electronic health records, also known as EMRs, have evolved for decades. Although initially configured largely for billing and administrative pursuits, their advances are central to patient care in many institutions. A variety of factors including technological advances, the internet, development of multi-institutional and geographically separated health care facilities, health care reform, and efforts to reduce medical errors and enhance medical research have driven this evolution. With the profusion of genomically driven data now available to many oncologists, the Expert Panel felt it appropriate to add a standard for EMR adoption when feasible.^38-41 ASCO-ONS recognizes the global readership of these standards. Some practices in various settings experience resource constraints and may have to implement this standard with written order entry.

Domain 2: Patient Consent and Patient Education

Standard 1.9: The patient’s medication list inclusive of prescribed and over-the-counter medications, herbal products, and supplements is updated and documented in the medical record at every encounter and reviewed by a licensed practitioner when a change occurs.

Standard 2.3.4 (new): Under Patient’s Diagnosis. Documentation of current medications to include herbal products and complementary medications.

Literature review update results and interpretation. Five observational studies were found by the systematic review relevant to this standard.^42-46 One study identified medication discrepancies in 83% of patients in a student pharmacist-driven service, with 21% of those discrepancies involving a high-risk medication.⁴² Authors reported potential herbal-product and drug interactions observed in one of five patients receiving oral anticancer agents.⁴³ Other authors evaluated over 200 interventions conducted by pharmacists during counseling sessions, and half of these interventions involved herbal-product and drug interactions.⁴⁴ In another study, on interactions with oral antineoplastics and other medications, including herbs, there were 51% potential drug interactions in 881 patients; the authors observed some risk factors, for example, polymedication, and specific cancer types.⁴⁶ In another descriptive study of drug-drug and drug-food interactions with oral antineoplastics, in 291 patients, there were 736 concomitant medications with only 55% detected.⁴⁷

Patients diagnosed with cancer often have other comorbidities and require multiple medications, which may suffer from unwanted polypharmacy. Furthermore, they may take herbal products and/or complementary medications including vitamins and supplements, which is why it is critical to ensure that patients’ medication lists are kept up to date for every visit. Pharmacists and providers should be aware of potential interactions between antineoplastics agents and herbal products and/or complementary medications. Some patients, at times, may not disclose their use of herbal product, supplements, and vitamins during interviews because they may not regard these as medications. Pharmacists and providers must proactively inquire and document herbal product and complementary medications use within the medication list.

Standard 2.3.5: [Education on] Potential long-term and short-term adverse effects of therapy, including infertility risks for appropriate patients.

Literature review update results and interpretation. No randomized trials or new observational studies regarding education on fertility preservation were identified by the systematic review which would change this prior standard. The Expert Panel refers readers to the ASCO Guideline on Fertility Preservation, which ASCO is currently updating,19 as well as an ONS, APHON, and CANO/ACIO position statement (in press, 2024).⁴⁸

The Expert Panel highlights the importance of policies educating patients regarding fertility issues especially in treatment of the pediatric population. Clinicians should discuss fertility issues in the context of informed consent (see Standard 1.5.3.3), through an interdisciplinary approach incorporating risk assessment, patient education, and potential referral to reproductive specialists for fertility preservation (in press, 2024).⁴⁸ Each health care organization should follow evidence-based guidance to define the details of its specific policies.

Standard 2.3.6: [Education on] Pregnancy prevention including contraception.⁴⁹

Literature review update results and interpretation. Since teratogenicity is a known complication of antineoplastic therapy,⁵⁰ advice on pregnancy prevention logically follows. The literature on intervention, however, is understandably limited. Authors conducted a systematic review and meta-analysis on contraceptive use and counseling. The results included 21 articles showing that contraceptive use and the prevalence of counseling varied widely. The authors found the results of counseling equivocal, with low uptake of contraceptives. The authors state this is an unmet need and that “Although fertility preservation is important for young women with cancer, it should not be the focus to the exclusion of contraceptive counseling.”⁴⁹ (p. 13) Although the field may still be struggling to find the best intervention, because pregnancy avoidance during therapy is the optimal approach, it is included in the standards.

Domain 3: Ordering, Preparing, Dispensing, and Administering

Note: The standards in Domain 3 have been reorganized to reflect the changes in the location of antineoplastic therapy to include patients’ homes and oral antineoplastic therapy facilities.

This includes adding an additional verification. (The 2016 standards referred to three independent verifications. [2016 Standard 3.11])

Note: Standards 3.11.2, 3.12, and 4.2 also include both home and health care facility settings.

Standard 3.12.2. (under 3.12—dispensing and administering, whether in a health care organization or at home): Personnel approved by the health care organization to prepare or administer antineoplastic therapy perform four separate verifications in person or by institutionally approved video-enabled technology.

The elements of each occasion of verification are listed separately (Table 6).

Standard 3.12.2.4. (new): Fourth Verification. In the presence of the patient: at least two licensed clinicians approved by the health care organization to administer or prepare antineoplastic therapy in person or through appropriate institutionally approved video-enabled technology, with at least one person on site, verify the patient’s identification using at least two identifiers and document accuracy in the patient’s medical record. Document the accuracy of the following elements in the patient’s medical record: (see the elements in Standards 3.12.2.4.1—3.12.2.4.6, Table 6).

Standard 3.12.2.2.5 (under second verification [3.12.2.2]): Administration route, filters, and tubing if applicable.

(see also Standard 3.12.2.4.5., under Fourth Verification) Standard 3.12.2.4.5.: Administration set (as applicable), for example, filters, specialized tubing.

Literature review update results and interpretation. As the administration of antineoplastic therapies in the home setting has become more common and preferable for patients with cancer, health care organizations should ensure that the same safety mechanisms are in place, regardless of where a patient receives treatment. This section is primarily based on expert experience and literature suggested by the Expert Panel. Advances in technology (such as video-enabled verification programs) have allowed health care providers to complete virtual safety checks in the drug preparation and administration processes, creating more flexibility for patients to receive care where they prefer.⁸ By expanding the standards to include use of institutionally approved video-enabled technology for the required two-person verifications, the Expert Panel acknowledges that technology has become an integral part of increasing access to care, but cautions that reliance on technology can still lead to medication errors or other serious safety events.⁹

Authors of a review of literature and synthesis of practice interviews regarding remote verification of high-risk medications report remote verification at the point of administration is feasible and may be alike live two-person checks; however, no well-designed research has evaluated the impact on safety as of this writing.⁵¹ Acknowledging this research gap, health care organizations that integrate technology for independent verification at the point of administration should ensure that the verification process, including independent inspection portions, is not compromised.

Previous versions of the ASCO-ONS standards required three independent verifications during the order verification, drug preparation, and drug administration processes. The standards reorganized Domain 3 because many antineoplastic drugs are prepared separately from where the patient is receiving treatment (eg, in the home setting or at a stand-alone ambulatory facility) and an additional verification is required to ensure that the drug and its components are accurate and complete immediately prior to drug administration. An additional element was added to the final verification to ensure that the administering health care provider visually inspects the administration set to ensure that it is appropriate for the drug, connected correctly to the patient, and infusing at the prescribed rate. “Tracing the lines” immediately prior to administration reduces errors related to unclamped tubing, loose or disconnected lines, ensures multiple lines are infusing at the prescribed rate, the right drug is connected to the right pump, and the proper tubing or filters are used.

Standard 3.12.8 (new): Cytokine release syndrome (CRS) management policy is present and aligns with current literature and guidelines when administering antineoplastics with this potential adverse effect. Antidote and CRS-directed therapy order sets and medications are accessible within the appropriate timeframe for optimal treatment.

Literature review update results and interpretation. New immune effector cell therapies, such as bispecific antibodies that may cause CRS, have been used since the 2016 standards. The Expert Panel expects significant uptake in general oncology clinics and according to ASCO guidance, “The incidence of CRS has been reported to range from 57% to 93%, on the basis of the agent used,”⁵² and thus, patients will need anticytokine therapywith reasonable frequency. Data fromclinical trials suggest that while late CRS can occur, the risk of CRS decreases substantially after step-up dosing is complete^53-56 and that anticytokine therapy may decrease the likelihood of subsequent CRS events while maintaining treatment response.⁵⁷ Currently, the prescribing information for most bispecific antibody therapies states that patients should receive step-up dosing in the inpatient setting although outpatient step-up dosing protocols exist in the literature.^58-60 The ASCO Guidelines state “Strongly consider evaluation and/ or transfer to a specialty center that has experience with CAR-T toxicity management. If treated in an outpatient setting, it is advisable that patients remain within 2 hours of the treating center for 4-8 weeks post-therapy and should return to their treating center upon experiencing any toxicities.”⁵²

Domain 4: Monitoring During and After Antineoplastic Therapy Is Administered, including Adherence, Toxicity, and Complications

Standard 4.2: The health care organization has a policy for emergent treatment of patients that aligns with current literature and guidelines and addresses:

4.2.1. Availability of appropriate emergency equipment and rescue agents and antidotes in the health care organization, whether in a health care facility or the patient’s home

4.2.2. Procedures to follow and a plan for escalation of care, when required, for life-threatening emergencies. (no change)

Literature review update results and interpretation. The updated standards add that preparation for emergencies must be ensured in the home whether provided by personnel from the health care organization, third party, and/or patients and caregivers. Otherwise, there were no major changes.

Standard 4.6: The health care organization has a policy that requires ongoing assessment of barriers to adherence, including social determinants of health and financial constraints (see also Standard 1.5.8).

Literature review update results and interpretation. Although the data regarding the impact of social determinants of health on adherence to oncologic therapeutics are relatively scarce, studies of medication adherence in general internal medicine populations are more robust, and the Expert Panel extrapolated from that experience and included these standards specific to antineoplastic therapy.^61,62 The oncology literature, like the general medicine literature, however, is notable for suboptimally constructed studies and multiple confounding variables, hence making definitive statements about interventions unreliable. Authors of one oncology systematic review which included studies addressing screening and education, including education of the health care provider, cognitive behavioral therapy, and more, found that no single optimal intervention was “best.”⁶³ An ONS oral adherence guideline makes conditional recommendations for education, screening, coaching, motivational interviewing, and, most importantly for Standard 4.6, ongoing assessment. The recommendations are mostly based on very low quality of evidence determinations.⁶⁴ The absence of high-level data to prove the benefits of intervention did not preclude including this standard. A better understanding of the social context of the patient’s cancer journey was sufficient to warrant its documentation.

Discussion

To optimize the safety of cancer care, ONS and ASCO have collaborated to refresh the antineoplastic administration standards. This document provides a blueprint for more than the administration of these potentially toxic medications only. It not only directs the specific act of delivering antineoplastic therapy but also addresses the steps before and after administration. The standards provide a guide for health care organizations to create processes to ensure quality and optimal patient outcomes and safety. The standards begin with the training of staff and patient education and progress through the ordering and preparation of the drugs and the delivery and administration to the patient at the bedside or chairside.

These standards present a minimum for health care organizations providing antineoplastic therapy. ASCO-ONS provides these standards as a foundation for institutions to create their own approaches consistent with their unique staffing characteristics, state laws, and institutional preferences, without intent to establish individual institutional workflow or policies. The standards offer a basis for institutional quality improvement and are consistent with ASCO-COA Oncology Medical Home Standards.⁷ Practices aspiring to the new ASCO Certified Patient-Centered Cancer Care Standards to qualify as an oncology medical home will need to adhere to these updated measures.⁶⁵

Ultimately, regardless of the quality of care provided by a health care organization, its success depends on the patient’s capacity to receive treatment as planned. The standards continue to stress the importance of assessing social determinants of health, which can significantly affect incidence, adherence, and compliance.^66-68 The providers’ role in assessment and management of financial toxicity is more formally highlighted. Although the importance of discussing fertility preservation before the initiation of anticancer therapy has been highlighted in both ONS and ASCO guidance, data from the adolescent and young adult population suggest insufficient implementation.^19,69,70 As a result, the Expert Panel has not only again highlighted the importance of fertility preservation but also added language stressing the need for pregnancy avoidance during treatment because of the risk of teratogenicity.

The refreshed standards also recognize the increasing complexity of antineoplastic therapy with specific mention of therapies and toxicities that were not part of the previous standards. For example, interventions that can induce CRS are mentioned as is maintaining appropriate therapies available to manage these more prevalent toxicities. In addition, the current standards attempt to level the significance of all antineoplastics—whether oral or parenteral, administered in a health care facility or in the home. When possible, the Expert Panel has merged standards when appropriate, regardless of the route of medication administration or setting.

To reduce human error, the ASCO-ONS standards have consistently relied on a double check or verification at various steps of the process of preparing and delivering antineoplastic therapy. Previous standards contained three steps. The refreshed standards now include a fourth verification at the patient’s location before administration.

The first verification occurs before the preparation of the drug(s), the second on preparation, and the third before administration. The new fourth verification includes verification of patient identification, drug, dose, and route and ensures that rate settings on any drug delivery device are accurately set and the patient and caregiver or family member know the plan.^8,9,71-74 The fourth verification anticipates that patients might receive the drug at a remote setting for which the health care organization has responsibility. The evolving complexity of oncologic care is not only its enlarging pharmacopeia. Insurers and pharmacy benefit plans have created a variety of novel relationships. Hence, physicians may prescribe drugs that are not administered in settings over which they have direct oversight or through white bagging or brown bagging may be required to administer drugs that have been prepared elsewhere.^75,76 These new standards attempt to clarify the relative responsibilities within these relationships to ensure these antineoplastics’ quality, provenance, and administration.

The development of these administration standards results from a careful review of data that define a problem or series of problems,⁹ with a paucity of randomized trials to provide solutions. The standards also account for evolving technologies meant to assist in the provision of safe care. Publications highlight the promise of such technology with limited controlled data. As a result, many of these standards are a common sense response to minimize identifiable sources of medical error in the administration of antineoplastics.

Additional information is available at www.asco.org/standards.

Health Equity Considerations

Social determinants of health, defined by the WHO as the conditions in which an individual is born, grows, lives, works, and ages, can undermine ASCO-ONS’s expert guidance on best practices for prevention, screening, palliative and supportive care, and disease management for many patients with cancer.24 It is important to acknowledge that many people in the United States and elsewhere do not receive the highest level of cancer care because of the long-term impact of structural racism and the consequential unequal distribution of wealth among racial groups.⁷⁷

In the United States, many patients remain unable to reap the benefits of innovative prevention and early detection programs, biomarker testing, and new cancer therapies because of structural barriers including lack of transportation, stable housing, and adequate insurance coverage as well as food insecurity, health literacy, proximity to a dedicated cancer center, and cost of treatment and other services.⁷⁸ In addition, sexual and gender minority people experience stigma along with barriers to cancer screening, prevention, and treatment that contribute to these cancer disparities.⁷⁹ Disparities widen in those who are also from a racial or ethnic minority, underscoring the influence of intersectionality in cancer health disparities.⁸⁰

Furthermore, geographic disparities can also affect the quality of care patients receive. Rural patients are more likely to have worse survivorship outcomes and experience higher mortality rates compared with nonrural patients. This can be attributed, in part, to a lower density of specialist providers and dedicated cancer centers as only 21% of nonmetropolitan counties in the United States have one or more practicing oncologists.⁸¹

Additional Resources

For current information, including selected updates, supplements, slide sets, and clinical tools and resources, visit www.asco.org/standards. The Supplement for the standards includes search terms. Listen to key insights from panel members on the ASCO Guidelines podcast. The ASCO Standards Policies and Procedures Manual (available at www.asco.org/standards) provides additional information about the methods used to develop these standards. Patient information is available at www.cancer.net.

ASCO welcomes your comments on these standards, including implementation challenges, new evidence, and how these standards impact you. To provide feedback, contact us at guidelines@asco.org. Comments may be incorporated into a future refresh. To submit new evidence or suggest a topic for development, complete the online form.

Gender-Inclusive Language

ASCO is committed to promoting the health and well-being of individuals regardless of sexual orientation or gender identity.⁸⁵ Transgender and nonbinary people, in particular, may face multiple barriers to oncology care including stigmatization, invisibility, and exclusiveness. One way exclusiveness or lack of accessibility may be communicated is through gendered language that makes presumptive links between sex and anatomy.^86-89 With the acknowledgment that ASCO guidance may impact the language used in clinical and research settings, ASCO is committed to creating gender-inclusive guidance. For this reason, authors use gender-inclusive language whenever possible throughout the standards. In instances in which the standards draw upon data on the basis of gendered research (eg, studies regarding women with ovarian cancer), the authors describe the characteristics and results of the research as reported.

About the Authors

Affiliations: Robert D. Siegel: Bon Secours St Francis Cancer Center, Greenville, SC; Kristine B. LeFebvre: Oncology Nursing Society (ONS), Pittsburgh, PA; Sarah Temin, Ronda M. Bowman, and Meredith Klein: American Society of Clinical Oncology (ASCO), Alexandria, VA; Amy Evers and David W. Dougherty: University of Pennsylvania Health System, Philadelphia, PA; Lisa Barbarotta: Smilow Cancer Hospital and Yale Cancer Center, New Haven, CT; Alexandre Chan: University of California, Irvine, Chao Family Comprehensive Cancer Center, National Cancer Centre Singapore, Irvine, CA; Michael Ganio: American Society of Health-System Pharmacists, Bethesda, MD; Bradley Hunter: Intermountain Health, Salt Lake City, UT; Tamara P. Miller: Emory University/Children’s Healthcare of Atlanta, Atlanta, GA; Therese Marie Mulvey: Massachusetts General Cancer Center, Boston, MA; Amanda Ouzts: Huntsville Hospital, Huntsville, AL; Martha Polovich: University of Maryland School of Medicine, Baltimore, MD; Maritza Salazar-Abshire: Department of Nursing Education, The University of Texas MD Anderson Cancer Center, Houston, TX; Elaine Z. Stenstrup: City of Hope National Medical Center, Duarte, CA; Christine Marie Sydenstricker: Hondros College of Nursing, Akron, OH; Susan Tsai: Ohio State University Comprehensive Cancer Center, Columbus, OH; and MiKaela M. Olsen: Johns Hopkins Hospital and Health System, Baltimore, MD. Reprinted with permission from ASCO. Approved by the ASCO Evidence-Based Medicine Committee, February 22, 2024. Approved by the ONS Board of Directors, February 14, 2024. Siegel and Olsen were Expert Panel co-chairs. ASCO can be reached at guidelines@asco.org, with copy to ONFEditor@ons.org.

The Expert Panel would like to thank Sunnie S. Kim, MD; Estelamari Rodriguez, MD, MPH (Evidence-Based Medicine Committee [EBMC] reviewers); Kerri Moriarty, MLS; and Caroline Clark, MSN, APRN, OCN^®, AG-CNS, EBP-C (ONS Staff); and the ASCO (EBMC) and ONS Board of Directors for their thoughtful reviews and insightful comments on these standards.

American Society of Clinical Oncology (ASCO) Standards are evidence-based standards to provide frameworks for best practices in cancer care, following the standards development process as outlined in the ASCO Standards Policies and Procedures Manual. ASCO Standards follow the ASCO Conflict of Interest Policy for Clinical Practice Guidelines. Standards and other guidance (“Guidance”) provided by ASCO is not a comprehensive or definitive guide to treatment options. It is intended for voluntary use by providers and should be used in conjunction with independent professional judgment. Guidance may not be applicable to all patients, interventions, diseases or stages of diseases. Guidance is based on review and analysis of relevant literature, and is not intended as a statement of the standard of care. ASCO does not endorse third-party drugs, devices, services, or therapies and assumes no responsibility for any harm arising from or related to the use of this information. See complete disclaimer in Appendix 1 (online only) for more. Additional information is available at www.asco.org/standards and www.ons.org/onf. Disclosures provided by the authors are available within this article at https://ascopubs.org/doi/full/10.1200/op.24.00216.

Siegel, LeFebvre, Temin, and Olsen contributed to the conception and design. Temin provided administrative support. Siegel, LeFebvre, Temin, Evers, Bowman, Chan, Ganio, Hunter, Miller, Ouzts, Polovich, Salazar-Abshire, and Olsen provided the data analysis and interpretation. All authors completed the collection and assembly of data, manuscript writing, and final approval of the manuscript, and are accountable for all aspects of the work.

Appendix 1. Standards Disclaimer

The Standards published herein are provided by the ASCO, Inc to assist providers in clinical decision making. The information herein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating provider, as the information does not account for individual variation among patients. ASCO provides this information on an “as is” basis and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information, or for any errors or omissions.

Appendix 2. Conflicts of Interest

The Expert Panel was assembled in accordance with ASCO’s Conflict of Interest Policy Implementation for Clinical Practice Guidelines (“Policy,” found at http://www.asco.org/guideline-methodology). All members of the Expert Panel completed ASCO’s disclosure form, which requires disclosure of financial and other interests, including relationships with commercial entities that are reasonably likely to experience direct regulatory or commercial impact as a result of promulgation of the standards. Categories for disclosure include employment; leadership; stock or other ownership; honoraria, consulting or advisory role; speaker’s bureau; research funding; patents, royalties, other intellectual property; expert testimony; travel, accommodations, expenses; and other relationships. In accordance with the Policy, the majority of the members of the Expert Panel did not disclose any relationships constituting a conflict under the Policy.