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PROCEDURE TITLE: CHEMOTHERAPY Oral ADMINISTRATION DEPARTMENT: Patient Care Departments USE WITH POLICY: APPROVED: DOCUMENT NUMBER: EFFECTIVE DATE: KEY WORDS: OSHA, ASHP, Chemo, Spill, Hazardous drug REVIEWED: REPLACES DOCUMENT DATED: SCOPE: This policy applies to all nursing, pharmacy, and environmental Services PURPOSE: To provide a standard for the safe handling, manipulation (crushing, splitting, opening capsules, or dissolving/mixing with food or water), and administration of oral chemotherapy/hazardous drugs. Definitions: A. Class B hazardous drugs: Any oral drug identified by at least one of the following six criteria: a. Cacinogenicity (risk of developing cancer) b. Teratogenicity (risk of adverse reproductive outcomes) or developmental toxicity c. Reproductive toxicity in humans d. Organ toxicity at low doses in human or animals e. Genotoxicity (risk for chromosomal changes) f. New drugs that mimic existing hazardous drugs in structure or toxicity, or their mechanism of action is such that the agent could be potentially toxic to healthy cells. B. Chemotherapy drugs: A harzardous agent whose primary purpose is to inhibit or prevent the proliferation of malignant cell populations or cause destruction of these cells; also called cytotoxic drugs or antineoplastic drugs. FORMS: Chemotherapy Administration Checklist EQUIPMENT: Chemotherapy Spill Kit Gloves - disposable, exam latex or non- latex Gloves – Thick, disposable, powder free, long cuffed chemotherapy gloves. Latex is preferred but non-latex is acceptable (i.e.: Patient/staff allergy or per drug-product manufacturer recommendation) Gown – Single use disposable, impermeable, closed front, lint-free, long sleeved, knitted cuffs Eye shield goggles Absorbent paper towel Plastic back liner Yellow biohazard container Knowledge of closest eye wash apparatus Chemotherapy Precaution sign Reference books, supports as available REQUIREMENTS: 1. Population Specific Considerations: If a pediatric patient should require chemotherapy: the Physician, Nurse manager of the Pediatric unit and Nurse manager of the Oncology unit will meet prior to the admission of the patient. 2. Nursing and Pharmacy personnel mixing or administering chemotherapy agents must be have completed the St. Joseph Hospital orientation and training for safely preparing and /or administering chemotherapy agents. 3. Any staff that is pregnant, breastfeeding, actively attempting to conceive in the near future (both male or female), or who have other medical reasons prohibiting exposure to chemotherapy may elect to refrain from administering these agents or caring for these patients during their treatment (up to 72 hours after completion of therapy). Staff with concerns should contact their Manager or Occupational Health. 4. An accurate height and weight will be obtained on each admission to determine the current BSA. If the current BSA indicates a significant variation (greater 10%) from the previous admission or the standard recommended dose range, the MD should be contacted to verify the need for any dose adjustments. 5. Obtain values of CBC (within last 3 days), liver and kidney functions (within last 7 days), and any other clinical assessment appropriate for the prescribed chemotherapy regimen. 6. All antineoplastic agents shall be prepared in a satellite pharmacy in accordance with pharmacy policies and procedures. 7. All manipulations of hazardous drugs will be done in the satellite pharmacy with a biological safety hood. This includes crushing or oral medications, opening of capsules, or mixing/dissolving medications with food or fluid (see attached for oral chemotherapy agents that may be manipulated). 8. Nursing to place a Spill Kit in the room where the chemotherapy is to be administered. 9. No verbal or phone orders for chemotherapy will be accepted. 10. All chemotherapy agents will be marked “Hazardous Agents” and transported by pharmacy and placed in the designated area (not into the patient bin in pyxis). PROCEDURE: 1. Patient Teaching to include (if applicable): a. b. c. d. e. Side effects Symptom management (i.e. nausea) Risks and benefits Use of equipment Discharge teaching 2. Complete Chemotherapy Administration Checklist 3. Place spill kit in the room where chemotherapy is to be administered. 4. Wash hands before and after each glove use. 5. Nurse will verify the delivery time with the chemotherapy pharmacist when the chemotherapy agents(s) will be sent to the floor. 6. Pre-medicate as ordered. Note if the drug is scheduled or PRN. 7. Chemotherapy drug preparation is done only in the Chemotherapy Satellite Pharmacy with appropriate safety precautions and equipment 8. Chemotherapy drugs are delivered to the nursing module in zip-lock bags marked "Biologic Hazard Cytotoxic Drug". The empty bag should be kept and used to contain the spoon, container, pill cup, mask, gown, and gloves when empty. 9. Pharmacy will deliver the chemotherapy, in a zip-lock bag, to the "YELLOW colored Chemotherapy Bucket", if being administered on the Oncology floor, and inform the administering RN that it has been delivered. Otherwise they will deliver the chemotherapy agent(s) to the nurse and will also deliver a Chemotherapy Spill Kit, if the drug is being administered in an area that does not contain such kit. 10. Use safe handling and disposal practices: Gowning Procedure Place one pair of exam gloves (latex or non-latex) on hands Gown with a disposable, impermeable chemotherapy gown. Place on a second pair of gloves that is thick, disposable, powder free and long cuffed. Latex is preferred but non-latex is acceptable. Tuck gloves over gown cuffs b. Gloves should be changed when leaving the patient room, sustaining a tear or puncture, after a drug spill, or after 30 minutes of continuous wear. c. A high efficiency filter respirator should be worn when administering aerosolized drug or the potential for the aerosolization of a drug, and when cleaning up a spill. 11. 12. 13. 14. 15. 16. 17. 18. Open package of medication Place in medicine cup Administer medication cup Put ALL material used in preparation and administration including gown, gloves, cup and packing in a re-sealable plastic bag Dispose of bag in puncture proof hazard waste container Observe for immediate adverse reaction (i.e. extravasation, anaphylaxis) Contact pharmacist and MD immediately if any adverse reaction occurs. Reassess the patient at least hourly unless indicated otherwise. 19. Use safe disposal practices: a. When handling blood, vomit, or other excreta of patients who are receiving or have received chemotherapy within the past 72 hours, wear thick, disposable, powder free and long cuffed gloves. Latex is preferred but non-latex is acceptable b. Flush toilet after use. Leave area immediately flushing to avoid aerosolization. c. Single use disposable, impermeable gowns are available as necessary. d. Eyewear available as necessary. e. Dispose of any chemotherapy bags, tubing, protective barriers, protective equipment, and linen by placing them in a red biohazard bag and putting that into the yellow biohazard container. f. Alert mortuary, pathologist, and/or coroner, at time of expiration, that the patient has received chemotherapeutic agents within previous 72 hours. Document "Chemotherapy Precautions" on Release of Body Record. 22. For eye and/or skin contamination Remove contaminated clothing and place in red biohazard bag. Place red bag in yellow biohazard container. Immediately wash skin x 3 with soap and water. Immediately flush eyes at sink with water or use liter bags of NS (Normal Saline) to irrigate eyes for at least 5 minutes. Contact Occupation Health e. Complete Employee Injury Report a. b. c. d. REFERENCES: JCAHO: RI 2.30, RI 2.90, PC 2.150, PC 3.230, PC 5.60 PROCEDURE: St. Joseph Hospital HIPP: view Chemotherapy Spill. St. Joseph Hospital HIPP: view Pain Assessment and Management OTHER: OSHA Technical Manual a. Section VI, Chapter 2, Controlling Occupational Exposure to Hazardous Drugs. b. Section VIII, Chapter 1 Chemical Protective Clothing. American Society of Health-Systems Pharmacists. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs 2007, p.47-62. Chemotherapy and Biotherapy: Guidelines and Recommendations for Practice, Oncology Nursing Society, 2009. Infusion Therapy in Clinical Practice 2nd Edition, Hankins, et al., 2001. Policies and Procedures for Infusion Nursing, 2nd Ed., Infusion Nurses Society, 2002. Pediatric Nursing 3rd Ed., Ruth C. Binder et al, 2003. Infusion Nursing Standards of Practice, Revised 2000 (Latest edition as of 9/8/04), Intravenous Nurses Society. HELP: MCU Nursing Team Leader or Oncology Pharmacist. Medication Aromasin Arimidex Busulfan Casodex Chlorambucil Cytadrem Dasatinib Erlotinib Faresten Femara Imatinib Mesylate Hexalen Lapatinib ditosylate Lenalidomide Melphalan Methotrexate Nexavar Nilotinib Revlamid Sanitinib Malate Targretin Temodar Thalimid Tasigna Tabloid Tarceva Tykerb Xeloda Zolinza Do not crush Can be crushed Unknown X Administration Considerations Take after meals X X Take on empty stomach if experiencing nausea and vomiting X Take 1 hour before, 2 hours after evening meal or at bedtime X X X Take 1 hour before or 2 hours after eating X X Take with a large glass of water X Take at bedtime Take 1 hour before or 2 hours after X Take on an empty stomach X Take 1 hour before or 2 hours after eating Take 1 hour before or 2 hours after eating, consume only water for 1 hour after taking X Avoid Grapefruit X X X Take on an empty stomach at bedtime Take with water 1 hour after meal X X X X Take 30 minutes after a meal