Antineoplastic Therapy Administration Safety Standards for Adult and Pediatric Oncology
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
| 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
Standa...
...n terminology changes: “Chem...
...ble 2. Domain 1: Creating a Safe Environme...
Standards – Do...
...alth care organization has a policy to documen...
....1.Description of initial educational requirem...
...n of (at least) annual, ongoing continu...
...on of credentialing processes (license...
...ption of competency demonstration an...
...e health care organization uses a compre...
...least one practitioner who maintai...
...licensed practitioner is on-site and immediately...
...3. Documentation Before First Administration
...ds – Domain 1 (cont’d)...
...the first administration of a new...
...thologic confirmation or verification of initial...
...ancer stage or current cancer status....
...plete medical history and physical examinat...
...iption of competency demonstration and how c...
1.5.3.2.The health care organization has a...
....3.The health care organization has a policy fo...
...or absence of allergies and history of hyper...
...sessment of the patient’s and/or caregiver...
....6.The plan for antineoplastic therapy, includin...
...7.Planned frequency of patient assessment...
...al and ongoing assessments of social determi...
...med consent and/or assent for the ant...
Table 4. Documentation: Each Clinical...
...s – Domain 1 (cont’d)...
1.6.On each clinical encounter or day...
....6.1.Functional status and/or performance...
...2.Vital signs...
...3.Date of birth....
...and previous treatment-related react...
....6.5.Treatment toxiciti...
1.6.6.Pain assessmen...
...Weight and height are measured and docume...
...Staff screens for and documents the patient’s...
....The patient’s medication list inclusi...
....10.The health care organization has a policy...
...care organization has a policy that addresses...
...e health care organization has a policy that i...
...lth care organization has a policy f...
...4.The health care organization has a pol...
1.15.The health care organization h...
...alth care organization uses an electronic medic...
...5. Domain 2: Patient Consent and Pat...
...ards – Domain 2...
...The health care organization has a...
...med consent and assent (if applicable...
...s are provided with verbal and wri...
...1.Patient’s diagnosi...
...als of treatment, that is, cure disease, pro...
....Planned duration of treatment, sched...
...tation of current medications to includ...
...Potential long-term and short-term adve...
...cy prevention including contracept...
2.3.7.Symptoms or adverse effects that re...
...ptoms or events that require immediate disc...
...s for safe handling medications in the ho...
....10.Follow-up plans, including labo...
...t information for the health care organi...
2.3.12.The missed appointment policy of t...
...4.Education includes family, caregivers, or o...
...6. Ordering...
...ards – Domain 3
...health care organization defines standa...
...health care organization verifies institutional...
...or antineoplastic therapy, regardless...
...health care organization has a poli...
...4.1.The policy requires a supporting re...
...onale for an exception order is documented in th...
...5.The health care organization has a po...
...ers are not allowed except to hold or stop...
...rs or changes to orders for antineoplastics, reg...
...are organization uses standardized, regimen-level...
...lth care organization administers parenteral a...
...the health care organization maintains i...
...tineoplastics (Both oral and parentera...
...ond patient identifier....
...2.The date the order was signed...
...9.3.Prescriber name
...9.4.Regimen name or protocol name and/or nu...
...Cycle number and day number, when applicable....
...tions within the order set are listed by using ful...
...re written following health care organiz...
...ose calculation, including:...
...calculation methodology....
...he variables used to calculate the dose....
....9.8.3.The frequency at which variables are re...
....4.The changes in the values that prom...
....The date of administrat...
....9.10.The route of administra...
...ergies, confirmed prior to administration o...
....Supportive care medications appropriate for t...
...eters that would require holding or...
...4.Sequencing of oral and/or parenteral drug...
...of drug administration for parenter...
...tion of time limitation, such as number of cycles...
...ing Oral Antineoplastics: All oral antineoplasti...
...ntity or volume to be dispensed....
...mber of refills, with zero being the preferred d...
....10.3.Schedule of administration.
...11.Preparation of Antineoplastics (Both oral...
...1.Oral or parenteral antineoplastics are prepar...
...Labels for oral or parenteral antineoplastics a...
3.11.2.1.Patient’s nam...
....2.Patient’s date of birth....
3.11.2.3.Prescriberâ€...
...11.2.4.Date of preparation and expira...
....5.Full generic name of the antineop...
....6.Drug dose....
...oute of administration....
...A label denoting HAZARDOUS DRUG, i...
...Specific for parenteral medications:...
....1.Total volume required to admini...
...3.2.Total number of products to be ad...
3.11.3.3.Date the medication is to be...
....3.4.A warning or precautionary labe...
...Specific for oral medications:...
...4.1.Dosage form of the medica...
...uantity to be dispensed within each container....
...of pills per dose when the container holds m...
...tration schedule, including number of times...
....5.Administration instructions related t...
3.11.4.6.A warning or precaution lab...
...7. Dispensing and Administration...
...ds – Domain 3 (cont'd...
...nsing and administering parenteral antineopl...
...licensed pharmacist verifies all order...
...nnel approved by the health care organizati...
...2.2.1.First Verification. Before pre...
....1.Two patient identifiers....
....1.2.Drug name....
...2.2.1.3.Drug dos...
...4.Route of administration....
...2.1.5.Rate of administratio...
....2.1.6.The calculations for dosing, includ...
....2.1.7.Treatment day and c...
...Second Verification. Upon preparation of the anti...
...2.1.The drug vial(s)...
....12.2.2.2.Concent...
....12.2.2.3.Drug volume or weight.
...2.4.Diluent type and volume when applic...
...dministration route, filters, and tubing if ap...
....12.2.3.Third Verification. After preparatio...
...2.3.1.Drug name....
...3.2.Drug dose....
...12.2.3.3.Infusion volume or drug volume w...
...12.2.3.4.Rate of administration...
...3.5Route of administration....
...2.3.6.Expiration date/...
....7.Appearance and integrity of the...
...4.Fourth Verification. In the presence...
...12.2.4.1.Drug...
...2.2.4.2.Drug dose...
....12.2.4.3.Rate and duration...
....2.4.4.Rate of administra...
...12.2.4.5.Administration set (as applicable...
....Before initiation of antineoplastic therapy...
...12.4.Parenteral antineoplastic therapy is adminis...
....5.Documentation in the patient’s medical re...
...ltration and extravasation management pol...
...2.7.Hypersensitivity and anaphylactoi...
...tokine release syndrome (CRS) managem...
...trathecal Administration of Antineoplastic Ther...
...rds – Domain 3 (cont'd)
...3.Dispensing and administering parentera...
...13.1.Prepared separately from other...
...immediately after preparation with...
....3.Stored in an isolated container or loca...
....Delivered to the patient only with other med...
....13.5.Administered immediately after a time o...
...The health care organization that ad...
.... Domain 4: Monitoring During and After Anti...
...ds – Domain 4...
....1.The health care organization uses standar...
...The health care organization has a polic...
...ability of appropriate emergency equipment and...
...cedures to follow and a plan for es...
....3.The health care organization has a policy that...
...alth care organization policy outli...
...alth care organization has a policy...
....1.The health care organization has...
4.5.2.The health care organization has a pol...
....5.3.Cumulative doses of antineoplasti...
...health care organization has a poli...