Antineoplastic Therapy Administration Safety Standards for Adult and Pediatric Oncology

Publication Date: May 22, 2024

Key Points

Key Points

  • These standards focus on the health care organizations providing a safe environment for patients receiving antineoplastic therapy, including through provider training, documentation, patient education, multiple verifications, monitoring. In addition, the standards require safe administration of therapy, regardless of route or site of administration (e.g., at some 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.

Table 1. Definition of Terms

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Term Definition
Adherence The degree or extent of conformity to the provider’s recommendations about day-to-day treatment regarding timing, dosing, and frequency.
Antineoplastic therapy/ antineoplastic regimen All antineoplastic agents used to treat cancer, regardless of the route. Types include targeted agents (e.g., small molecule inhibitors), chemotherapy, and immunotherapy (e.g., monoclonal antibodies, checkpoint inhibitors, biologics, cellular therapies). Hormonal therapies are not included in the definition of antineoplastic agents for these standards.
Antineoplastic treatment plan A treatment plan specific to the patient developed before the initiation of antineoplastic therapy.
Assent Assent expresses a willingness to participate in a proposed treatment by persons who, by definition, are too young to give informed consent, but who are old enough to understand the diagnosis and proposed treatment in general, its expected risks, and possible benefits; however, assent, by itself, is not sufficient. If assent is given, informed consent must still be obtained from the patient’s parents or guardian, both of which must be done according to all applicable state and federal laws (see Consent definition).
Basic life support Certification can be obtained and is time limited. (e.g., American Heart Association)
Basic life support is a term used to describe maintenance of a clear airway and support of breathing and the circulation in cases of cardiac arrest.
Cancer stage A formal, standardized categorization of the extent to which a cancer has spread at diagnosis. Systems vary by tumor type and staging but should be specific to the tissue of tumor origin. Stage should be distinguished from cancer status. Cancer status does change over time.
Cancer status Description of the patient’s disease from the time of diagnosis, if relevant (e.g., recurrence, metastases).
Cancer support services A list of informational, psychosocial, and financial resources available for cancer support.
Combination antineoplastic therapy/regimen One or more antineoplastic agents used alone or in combination in a well-defined protocol or course of treatment, generally administered cyclically.
Clinical encounter Clinical encounters include each inpatient day, scheduled or unscheduled practitioner visits, home visits, and antineoplastic therapy administration or supportive care visits, but not laboratory or administrative visits.
Clinician Staff involved in patient care—may be licensed (e.g., registered nurse or pharmacist) or unlicensed (e.g., patient care assistant).
Comprehensive education program A comprehensive educational program is current, evidence-based, and age appropriate. It may be internally developed, or an established educational curriculum may be used. Education and competency assessment regarding antineoplastic therapy administration includes all routes of administration used in the practice or institution or home site and safe handling of hazardous antineoplastic therapy agents and concludes in clinical competency assessment. Examples of education programs for staff administering antineoplastic therapy agents include the ONS/ONCC Chemotherapy Immunotherapy Certificate Course and the Association of Pediatric Hematology/ Oncology Nurses (APHON) Pediatric Chemotherapy and Biotherapy Provider Program.
Consent Consent is the process by which a patient is provided with sufficient information about the disease diagnosis and treatment options so that the individual can make a reasonable decision about treatment based on an understanding of the potential risks and anticipated benefits of the treatment. Informed consent is not a waiver of rights.
Dosage Includes the amount or quantity of medicine to be taken or administered and indicates the duration or the frequency of the dose to be administered—e.g., once daily, once every 21 days, etc.
Dose The amount or quantity of medicine to be taken or administered to the patient each time in a day.
Exception order A request for antineoplastics or doses of antineoplastics that differs from the standardly available institutional treatments for a given condition. Examples include using an order set for a disease not assigned, adding a medication not included in the standard regimen, escalation of dose or schedule beyond that defined in a standard regimen.
Functional status A narrative description of an individual’s ability to perform normal daily activities required to meet basic needs, fulfill usual roles, and maintain health and well-being.
Handoff The transfer of patient information and knowledge, along with authority and responsibility, from one clinician or team of clinicians to another clinician or team of clinicians during transitions of care across the continuum.
Health care organization Entity responsible for antineoplastic therapy ordering, preparation and administration regardless of the setting including but not limited to a medical office or practice, clinic, agency, company, hospital, or the patient or caregiver’s home.
Heath care facility A location that devotes some or all of its resources (people, places, things) to the delivery of medical services (including the financial and administrative management of those resources), a distinction from the home as a place for the provision of care.
Hypersensitivity/ Anaphylactoid reaction A symptomatic interaction between antibodies and allergens that causes an exaggerated and harmful response in the body. Hypersensitivity reactions range from mild to life threatening in severity and symptoms. Anaphylaxis reactions range from severe to life-threatening immune reactions.
Identifier (patient identification) A set of parameters which, when taken, are unique to the individual. These can include but are not limited to:
Last name, first name, date of birth, unique identification number, such as medical record number. Whenever possible, ask patients to state their full name and date of birth. For patients who are unable to identify themselves—pediatric, unconscious, confused, or language barrier—seek verification of identity from a parent or caregiver and/ or from interpreter services (if language barrier) at the bedside. This must exactly match the information on the identity band, order, or drug label (or equivalent). All paperwork that relates to the patient must include, and be identical in every detail, to the minimum patient identifiers on the identity band.
Immediate use For the purpose of these standards, immediate use is defined as use within two hours in accordance with drug stability and state and federal regulations.
Independent verification Independent verification is the act of verifying or checking the status or quality of a component or product independent of the person that established its present state. Independent verification has a higher probability of catching an error than does peer-checking or concurrent verification, as the second person is not influenced by the first person and has freedom of thought.
Independent verification catches errors after they have been made. The individual performing the independent verification must physically check the condition without relying on observation or verbal confirmation by the initial performer. True independence requires separation in time and space between the individuals involved to ensure freedom of thought. Independent verification of antineoplastic therapy preparation should include checking the preparation for completeness and accuracy of content, with particular attention given to special preparation instructions. Technology can serve as a surrogate during the preparation (i.e., mixing, compounding) process based on ample evidence showing equivalent safety outcomes and if practitioners follow procedures in using appropriately developed and applied procedures. Verification may include bar code and/or gravimetric verification and may be performed on site or remotely via digital images or video as allowed by state law or other regulations.
Labels A descriptor which is tightly affixed to an antineoplastic agent which identifies its contents, dose, and parameters of administration. The required components of the label and their verification are detailed in the standards.
Licensed practitioner Any individual permitted by law and by the medical staff and board to provide care and services without direction or supervision within the scope of the individual’s license and consistent with individually granted clinical privileges, e.g., doctor of medicine (MD), nurse practitioner (NP), physician’s assistant (PA), certified nursing specialist (CNS), etc.
Medical Record Document containing specifics of patient care in either electronic or written form.
Medical history and physical Includes, at minimum, height, weight, pregnancy screening (when applicable), treatment history, and assessment of organ-specific function as appropriate for the planned regimen.
On-site and immediately available Physically present, interruptible, and able to furnish assistance and direction throughout the performance of the procedure.
Orders: written and verbal Patient care communications that are written or sent electronically must be transmitted in a Health Insurance Portability and Accountability Act (HIPAA) compliant manner. They can be on paper (written or faxed) or emailed from a secure encrypted computer system and include the licensed independent practitioner’s signature and, in some instances, an identifying number.
Verbal orders are those that are spoken aloud in person or by telephone and offer more room for error than do orders that are written or sent electronically.
Parenteral Introduction of substances by intravenous, intra-arterial, subcutaneous, intramuscular, intrathecal, intraventricular, or intracavitary routes.
Performance status The use of standard criteria for measuring how the disease impacts the patient’s daily living abilities, usually represented numerically.
Policy A written course of action—for example, procedure, guideline, protocol, or algorithm.
Psychosocial assessment An evaluation of a person’s mental health, social status, and functional capacity within the community. May include the use of a distress-, depression-, or anxiety-screening form, patient self-report of distress, depression, or anxiety, or medical record documentation regarding patient coping, adjustment, depression, distress, anxiety, emotional status, family support and caregiving, coping style, cultural background, and socioeconomic status.

Standards

...tandard...

...minology changes: “Chemotherapy” change...


.... Domain 1: Creating a Safe Environm...

...dards – Domain 1...

...ealth care organization has a poli...

....1.Description of initial educational...

...on of (at least) annual, ongoing continuing e...

...1.3.Description of credentialing processes (licen...

...scription of competency demonstration and how co...

...alth care organization uses a compr...

....3.At least one practitioner who maintains cu...

1.4.A licensed practitioner is on-s...


...mentation Before First Administration...

...– Domain 1 (cont’d)...

...Before the first administration of...

...thologic confirmation or verification of initia...

....Initial cancer stage or current cancer sta...

...e medical history and physical examination, inclu...

...cription of competency demonstrati...

....3.2.The health care organization has a...

...3.The health care organization has a poli...

...5.4.Presence or absence of allergi...

....5.5.Assessment of the patient’s a...

...e plan for antineoplastic therapy,...

....Planned frequency of patient assessments a...

...ial and ongoing assessments of social...

....9.Informed consent and/or assent for the...


...tation: Each Clinical Encounter or Treatment Da...

...ards – Domain 1 (cont’...

...ical encounter or day of treatment, st...

...6.1.Functional status and/or performance sta...

....2.Vital signs....

....6.3.Date of b...

...es and previous treatment-related reactions....

....6.5.Treatment toxi...

....6.Pain assessm...

....Weight and height are measured and documented...

...screens for and documents the patient...

...atient’s medication list inclusive of prescribe...

...alth care organization has a policy for docu...

...care organization has a policy that addresses ma...

...ealth care organization has a policy that...

...ealth care organization has a policy for stand...

...care organization has a policy for hand-off p...

...The health care organization has a policy...

...e health care organization uses an electron...


...e 5. Domain 2: Patient Consent and Patient Edu...

...ndards – Domain 2...

...care organization has a policy that documents...

...rmed consent and assent (if applica...

...provided with verbal and written or electroni...

....Patient’s diagnosis....

....2.Goals of treatment, that is, cur...

...nned duration of treatment, schedule of tre...

...mentation of current medications to...

...tial long-term and short-term adverse effects of...

...6.Pregnancy prevention including contraception....

....3.7.Symptoms or adverse effects that require...

...r events that require immediate discontinua...

...edures for safe handling medications...

...ollow-up plans, including laboratory and...

...ntact information for the health care organi...

...3.12.The missed appointment policy of the he...

....4.Education includes family, caregiv...


...ble 6. Order...

Standards – Domain 3

...alth care organization defines stan...

...alth care organization verifies institutional revi...

....Orders for antineoplastic therapy, regardle...

...ealth care organization has a policy for managin...

...requires a supporting reference and/or authorizat...

...2.The rationale for an exception orde...

...he health care organization has a polic...

...bal orders are not allowed except to hold or s...

...or changes to orders for antineoplasti...

...health care organization uses standa...

3.7.If the health care organization administers...

...th care organization maintains its own pharm...

...Ordering Antineoplastics (Both oral and...

....1.A second patient identifier.

...date the order was signed...

....Prescriber name...

...en name or protocol name and/or number...

3.9.5.Cycle number and day number, w...

...ll medications within the order set a...

...e written following health care organization pol...

3.9.8.The dose calculation, including:

....The calculation methodology....

...iables used to calculate the dose....

...8.3.The frequency at which variables are re-...

....4.The changes in the values that...

...ate of administration....

...The route of administration....

....Allergies, confirmed prior to adm...

...rtive care medications appropriate fo...

3.9.13.Parameters that would require ho...

...quencing of oral and/or parenteral...

...drug administration for parenteral medi...

...6.Explanation of time limitation, such as number...

...Oral Antineoplastics: All oral antineopla...

...quantity or volume to be dispensed....

...2.Number of refills, with zero being the pre...

....3.Schedule of administration....

...ation of Antineoplastics (Both oral and parenter...

...1.Oral or parenteral antineoplastics are prepar...

...for oral or parenteral antineoplastics and sup...

....2.1.Patient’s n...

...1.2.2.Patient’s date of birth.

...1.2.3.Prescriber’s...

...Date of preparation and expiration, day and/or ti...

...l generic name of the antineoplastic and suppor...

....11.2.6.Drug...

....11.2.7.Route of administ...

....11.2.8.A label denoting HAZARDOUS DRUG, if appli...

...11.3.Labels Specific for parenteral...

....3.1.Total volume required to administer the...

...al number of products to be administer...

....11.3.3.Date the medication is to be administe...

....3.4.A warning or precautionary label or...

...11.4.Labels Specific for oral me...

....11.4.1.Dosage form of the medication.

...antity to be dispensed within each conta...

...of pills per dose when the container hold...

....11.4.4.Administration schedule, including...

...dministration instructions related to food ingest...

....6.A warning or precaution label, as a...


...able 7. Dispensing and Admi...

...andards – Domain 3 (cont'...

...12.Dispensing and administering parentera...

....1.A licensed pharmacist verifies all orders...

...nnel approved by the health care or...

...2.2.1.First Verification. Before preparation o...

...2.1.1.Two patient identifiers.

...12.2.1.2.Drug na...

....2.1.3.Drug dos...

...4.Route of administration...

....1.5.Rate of administration....

...2.1.6.The calculations for dosing, incl...

...2.1.7.Treatment day and cy...

3.12.2.2.Second Verification. Upon preparation o...

...12.2.2.1.The drug vial(s)....

....2.2.Concentration

....2.3.Drug volume or weig...

...Diluent type and volume when applicable....

....2.5.Administration route, filters, and...

...2.3.Third Verification. After preparation an...

...3.1.Drug name....

....2.3.2.Drug dos...

3.12.2.3.3.Infusion volume or drug volume w...

....3.4.Rate of administration....

...2.3.5Route of administrat...

...6.Expiration date/times....

...arance and integrity of the drugs.

...ourth Verification. In the presence...

...2.2.4.1.Drug na...

...12.2.4.2.Drug dos...

...2.2.4.3.Rate and duration of...

3.12.2.4.4.Rate of administrat...

...2.4.5.Administration set (as applicab...

...nitiation of antineoplastic therapy,...

...arenteral antineoplastic therapy is administer...

...entation in the patient’s medical record...

...ration and extravasation management...

....12.7.Hypersensitivity and anaphylactoid m...

...8.Cytokine release syndrome (CRS) management pol...


...ble 8. Intrathecal Administration of Antineoplast...

...– Domain 3 (cont'd...

...and administering parenteral antineoplastics...

...separately from other antineoplast...

...immediately after preparation with a...

...d in an isolated container or location...

...d to the patient only with other medications inten...

...tered immediately after a time out, doub...

....The health care organization that...


.... Domain 4: Monitoring During and After Antineo...

...ards – Domain 4...

...ealth care organization uses standard, di...

...health care organization has a policy for emer...

...ty of appropriate emergency equipment and...

...es to follow and a plan for escalation of care,...

...3.The health care organization has a policy...

...he health care organization policy ou...

...lth care organization has a policy that st...

...The health care organization has a pol...

...ealth care organization has a policy that...

....5.3.Cumulative doses of antineoplastic...

...h care organization has a policy th...