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
Standar...
...terminology changes: “Chemotherap...
...e 2. Domain 1: Creating a Safe Environment fo...
...ndards – Doma...
...1.The health care organization has a...
...scription of initial educational requirements and...
...2.Description of (at least) annual, ongoing cont...
...tion of credentialing processes (licensed...
...scription of competency demonstration and how...
...th care organization uses a comprehensive e...
...t least one practitioner who maint...
...icensed practitioner is on-site and i...
...3. Documentation Before First Administration...
...tandards – Domain 1 (cont’...
....Before the first administration of a new antineop...
...gic confirmation or verification of...
1.5.2.Initial cancer stage or current...
1.5.3.Complete medical history and physi...
1.5.3.1.Description of competency demonstratio...
....5.3.2.The health care organization h...
...he health care organization has a policy...
...ce or absence of allergies and history of hyperse...
...ssment of the patient’s and/or caregiver’s...
...e plan for antineoplastic therapy, including, at...
...ned frequency of patient assessments and monitorin...
...nd ongoing assessments of social determina...
...consent and/or assent for the antineoplastic th...
...le 4. Documentation: Each Clinical Encounte...
...rds – Domain 1 (cont’d)...
....On each clinical encounter or day of...
...status and/or performance status.
....Vital signs.
....Date of birth....
....6.4.Allergies and previous treatment-related re...
....6.5.Treatment toxi...
....6.Pain assessment.
...eight are measured and documented in the medica...
...creens for and documents the patient’s...
...t’s medication list inclusive of pres...
...he health care organization has a polic...
...th care organization has a policy that...
...h care organization has a policy that identifi...
...th care organization has a policy for standar...
...The health care organization has a policy for...
...he health care organization has a po...
...th care organization uses an electronic...
...5. Domain 2: Patient Consent and Patie...
...rds – Domain 2
...h care organization has a policy that document...
...d consent and assent (if applicabl...
...are provided with verbal and written or electro...
...ient’s diagnosis....
....3.2.Goals of treatment, that is, cu...
...ed duration of treatment, schedule...
...mentation of current medications to inclu...
...tial long-term and short-term adverse effec...
...Pregnancy prevention including contrace...
....7.Symptoms or adverse effects that require the p...
...or events that require immediate disc...
2.3.9.Procedures for safe handling medi...
...w-up plans, including laboratory and/or p...
...tact information for the health care...
...missed appointment policy of the health care...
...on includes family, caregivers, or o...
...e 6. Ordering...
...ards – Domain 3...
...care organization defines standard antine...
....2.The health care organization verifies inst...
...Orders for antineoplastic therapy, re...
....4.The health care organization has a pol...
...icy requires a supporting reference...
....The rationale for an exception order is documente...
...alth care organization has a policy for antineop...
...l orders are not allowed except to hold or stop...
...ers or changes to orders for antineop...
....The health care organization uses standa...
...health care organization administers parenter...
...8.If the health care organization maintai...
...Antineoplastics (Both oral and parenteral...
...1.A second patient identifier....
...date the order was signed....
....Prescriber name
...name or protocol name and/or numb...
...number and day number, when applicable....
...dications within the order set are listed by usin...
...ses are written following health care organ...
...The dose calculation, inclu...
....9.8.1.The calculation met...
...variables used to calculate the dose....
...8.3.The frequency at which variables are re-e...
...hanges in the values that prompt conf...
....The date of administration....
...10.The route of administrati...
...llergies, confirmed prior to administr...
3.9.12.Supportive care medications appropriate...
3.9.13.Parameters that would require holding or...
3.9.14.Sequencing of oral and/or p...
...e of drug administration for parenteral medicati...
...ion of time limitation, such as number of cycles f...
....Ordering Oral Antineoplastics: All oral a...
3.10.1.Drug quantity or volume to...
...umber of refills, with zero being the preferred de...
...dule of administration....
...paration of Antineoplastics (Both ora...
...ral or parenteral antineoplastics are prepa...
...2.Labels for oral or parenteral antineoplas...
....11.2.1.Patient’...
...tient’s date of birth....
3.11.2.3.Prescriber’s n...
...Date of preparation and expiration, day and...
...5.Full generic name of the antineoplast...
....6.Drug dose....
...7.Route of administration....
....2.8.A label denoting HAZARDOUS DRUG, i...
...s Specific for parenteral medications:...
3.11.3.1.Total volume required to administ...
....2.Total number of products to be administe...
....11.3.3.Date the medication is to be administered....
...A warning or precautionary label or stick...
3.11.4.Labels Specific for oral medi...
...ge form of the medication....
...4.2.Quantity to be dispensed within eac...
...er of pills per dose when the conta...
....11.4.4.Administration schedule, includ...
....4.5.Administration instructions related to food i...
...arning or precaution label, as applicable, for s...
...ble 7. Dispensing and Administrati...
Standards – Domain 3 (cont'd...
...ensing and administering parenteral...
...1.A licensed pharmacist verifies all orders be...
...Personnel approved by the health care o...
....2.1.First Verification. Before preparation...
...Two patient identifiers....
....12.2.1.2.Drug name.
...2.1.3.Drug dos...
...1.4.Route of administration.
...5.Rate of administration....
...2.1.6.The calculations for dosing, includ...
...2.1.7.Treatment day and cycle....
...2.2.Second Verification. Upon preparatio...
...1.The drug vial(s).
....12.2.2.2.Concentr...
...2.3.Drug volume or weight....
...ent type and volume when applicable....
...inistration route, filters, and tubing...
....3.Third Verification. After preparation and...
....3.1.Drug name....
...3.2.Drug dose....
....3.3.Infusion volume or drug volume...
....2.3.4.Rate of administration....
...Route of administration....
....12.2.3.6.Expiration d...
...earance and integrity of the drugs....
...th Verification. In the presence of the patient...
3.12.2.4.1.Drug na...
...2.2.4.2.Drug dose....
...te and duration of infusion...
....12.2.4.4.Rate of administration...
...istration set (as applicable) e.g., filter...
....Before initiation of antineoplastic thera...
...al antineoplastic therapy is administered by a...
...Documentation in the patient’s medical rec...
...filtration and extravasation management policy i...
3.12.7.Hypersensitivity and anaphylact...
...release syndrome (CRS) management polic...
...thecal Administration of Antineoplastic...
...s – Domain 3 (cont'd)...
...and administering parenteral antineoplastics wheth...
...ed separately from other antineopl...
...immediately after preparation with a uniquely...
...red in an isolated container or lo...
...elivered to the patient only with other medication...
...Administered immediately after a time out...
....6.The health care organization that administ...
...main 4: Monitoring During and After...
...ds – Domain 4...
...care organization uses standard, d...
...2.The health care organization has a...
...lability of appropriate emergency equipme...
...res to follow and a plan for escalation of car...
...care organization has a policy that determines th...
4.4.The health care organization polic...
...5.The health care organization has a p...
...he health care organization has a po...
...health care organization has a poli...
...ative doses of antineoplastic therapy are tra...
...h care organization has a policy that requires ong...