STANDARDIZED PROCEDURE MANAGEMENT OF CHEMOTHERAPY (ADULT, PEDS)

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I. Definition Chemotherapy is the use of cytotoxic drugs, hormones, antihormones, and biologic agents to treat malignancies. Selection of specific drugs or protocols is based on results of prior/ongoing clinical trials. Advanced Health Practitioners may only write for continuation orders for Chemotherapy. No initial Chemotherapy order sets may be initiated by an AHP. II. Background Information A. Setting: The setting (inpatient vs outpatient) and population (adults vs pediatrics) for the Advanced Health Practitioner (AHP) is determined by the approval of the privileges requested on the AHP Privilege Request Form. If the procedure is being done on a Pediatric patient, make sure Child Life is involved and use age appropriate language and age appropriate developmental needs with care of children, as appropriate to the situation. B. Supervision: The necessity of the procedure will be determined by the AHP in verbal collaboration with the attending Oncologist or his/her designee. Direct supervision will not be necessary once competency is determined, as provided for in the protocol. At that time, general or indirect supervision is acceptable. Designee is defined as another attending physician who works directly with the supervising physician and is authorized to supervise the AHP. The Advanced Health Practitioner will notify the physician immediately upon being involved in any emergency or resuscitative events or under the following circumstances: 1. Patient decompensation or intolerance to the procedure 2. Bleeding that is not resolved 3. Outcome of the procedure other than expected C. Indications Chemotherapy is standard treatment for many malignancies, including, but not limited to, breast cancer, lung cancer, prostate cancer, bladder cancer, ovarian cancer, leukemia, lymphoma, myeloma, melanoma and GI cancers. The standardized procedure is developed to enable the nurse practitioner, under the direct supervision of the Hematology/Oncology attending physician staff to order subsequent courses of established chemotherapy regimens, and clinical trial chemotherapy regimens, after the physician has established the treatment plan and written the initial chemotherapy orders. D. Precautions/Contraindications Patients will be continually monitored for excessive toxicities, progression of disease and concurrent illnesses that would contraindicate receiving chemotherapy treatment. 1

1. Excessive toxicities could include, but not be limited to, excessive myelosuppression, uncontrolled nausea and vomiting and/or diarrhea, electrolyte imbalances, elevated liver function tests, acute renal insufficiency, fever, rashes, respiratory toxicity or unacceptable neurotoxicity. E. Materials 1. Chemotherapy for injection to be prepared by UCSF Pharmacy staff 2. Oral or self-injectable chemotherapy medicines to be obtained by the patient from a licensed pharmacy for home use. III. Management of Chemotherapy Procedure A. Pretreatment evaluation: 1. History of malignancy appropriate to chemotherapy regimen planned by patient s Hematology/Oncology attending physician. 1. History of previous side effects, or adverse reactions experienced with chemotherapy 2. Patient evaluation: general appearance and vital signs; fever, signs/symptoms of infection; focused physical exam signs of progressive disease 3. Diagnostics: Bone Marrow Aspiration and Biopsy, Lumbar Puncture; CBC, plt, diff, smear, creat, lytes, creatinine clearance, LFTs, PT/PTT, INR, chest x-ray; CT scan/pet scan/mris as indicated by patient restaging requirements; disease status and protocol/clinical trails requirements a. Review all abnormal/unexpected findings with Attending Oncologist. B. Patient Preparation 1. Review risks, benefits, side effects, adverse reactions as needed prior to chemotherapy administration, initial informed consent obtained by attending physician 2. Renew and revise premedications, hydration, and antiemetic therapy as needed 3. Provide written and verbal information as needed C. Chemotherapy orders procedure 1. Verify patient height and weight and recalculate BSA 2. Confirm doses and dose adjustment parameters specific to chemotherapy protocols 3. Write antiemetics and premedication orders appropriate to chemotherapy protocol (see UCSF Pharmacy Antiemetic guidelines: http//yew.ucsf.edu) 4. Write chemotherapy orders per Attending Oncologist original orders and utilize UCSF chemotherapy guidelines (http//yew.ucsf.edu). 2

Procedure performed only by a Hematology/Oncology AHP who meets the clinical skills outlined in the competency assessment in Section V below. IV. Documentation A. Documentation is in the electronic medical record 1. Documentation of the pretreatment evaluation 2. Record the time out, procedure, EBL, the outcome, patient tolerance, medications given, and the plan in the note, as well as any teaching and discharge instructions. 3. Written record reflects; indication for medication, drug allergies, patient response, side effects and/or techniques of use, need for management of serum drug levels and/or monitoring of other laboratory/diagnostic studies as indicated. B. All abnormal findings are reviewed with supervising physician V. Competency Assessment A. Initial Competence 1. The Advanced Health Practitioner will be instructed on the efficacy and the indications of this therapy and demonstrate understanding of such. 2. The Advanced Health Practitioner will demonstrate knowledge of the following: a. Medical indication and contraindications of chemotherapy b. Risks and benefits of the procedure c. Related anatomy and physiology d. Consent process (if applicable) e. Steps in performing the procedure f. Documentation of the procedure g. Ability to interpret results and implications in management. 3. If the Advanced Health Practitioner possesses a valid Furnishing number/certificate and has a minimum of three years of oncology experience, and/or has completed a chemotherapy certification class; the Advanced Health Practitioner will write orders and furnish medications consistent with the Standardized Procedure for three months under direct supervision of an attending Oncologist, and with physician co-signature of all orders/prescriptions. 4. If the Advanced Health Practitioner does not possess a Furnishing certificate, the Advanced Health Practitioner must apply for furnishing privileges and undergo the 6 month preceptorship required before completing the above initial competency. 3

5. Advanced Health Practitioners with less than three years direct care experience with Hematology/Oncology/Bone Marrow Transplant patients are required to complete a chemotherapy certification class prior to ordering chemotherapy. Once class is completed, the AHP will complete three months of direct supervision by an attending Oncologist to write any chemotherapy orders including an attending co-signature. 6. Advanced Health Practitioner with less than three years of Hematology/Oncology experience will be under the direct supervision of a Hematology/Oncology attending Oncologist, and all orders will be reviewed and cosigned by the attending physician for six months. 7. Advanced Health Practitioners may only write for continuation orders for Chemotherapy. No initial Chemotherapy order sets may be initiated by an AHP. B. Continued proficiency 1. Only an Advanced Health Practitioner who has successfully met the requirements for initial competency, is currently licensed as a AHP in the state of California and who meets the clinical skills as outlined below may perform these procedures. 2. Each Advanced Health Practitioner will be initially proctored and signed off by an attending Oncologist. The Advanced Health Practitioner must perform this activity at least 20 times per year. In cases where this minimum is not met, the Hematology/Oncology attending physician must again proctor and sign off the procedure for the Advanced Health Practitioner. The Advanced Health Practitioner will be signed off by the proctor after demonstrating 100% accuracy in completing the procedure. 3. Demonstration of continued competence shall be monitored through annual evaluation, departmental chart audits, departmental quality improvement measures, and documentation of successfully performing ten orders within the preceding year. 4. Advanced Health Practitioners may only write for continuation orders for Chemotherapy. No initial Chemotherapy order sets may be initiated by an AHP. A clinical practice outcomes report is to be submitted with each renewal of credentials. It will include the number of procedures performed per year and any adverse outcomes. If an adverse outcome occurred, a copy of the procedure note will be submitted. VII. RESPONSIBILITY Questions about this procedure should be directed to the Chief Nursing and Patient Care Services Officer at 353-4380. VIII. HISTORY OF PROCEDURE Revised March 2012 by Subcommittee of the Committee for Interdisciplinary Practice Reviewed March 2012 by the Committee on Interdisciplinary Practice 4

Prior revision Sept 2009 Approved March 2012 by the Executive Medical Board and the Governance Advisory Council. This procedure is intended for use by UCSF Medical Center staff and personnel and no representations or warranties are made for outside use. Not for outside production or publication without permission. Direct inquiries to the Office of Origin or Medical Center Administration at (415) 353-2733. 5