REFERENCES American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:

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Cameron Lawrence
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Ordering and Handling Applies To: UNM Hospitals Responsible Department: Pharmacy Revised: 8/2017 Procedure Patient Age Group: ( ) N/A (X) All Ages ( )Newborns ( )Pediatric ( )Adult

1 Ordering and Handling Applies To: UNM Hospitals Responsible Department: Pharmacy Revised: 8/2017 Procedure Patient Age Group: ( ) N/A (X) All Ages ( )Newborns ( )Pediatric ( )Adult DESCRIPTION/OVERVIEW UNM Hospitals (UNMH) will maintain a standard process for prescribing, preparing, storing, dispensing and administering chemotherapy drugs to minimize the possible adverse consequences of chemotherapy agents. REFERENCES American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63: AREAS OF RESPONSIBILITY All UNMH units where chemotherapy is utilized; The UNMH Pharmacy and Therapeutics Committee; Department of Pharmaceutical Services; UNMCC. PROCEDURE 1. The Director of Pharmaceutical Service is responsible for developing policies and procedures that are in compliance with the full spectrum of chemotherapy drug control. 2. Receiving and storing of cytotoxic agents: 2.1. Prevention of accidental contamination of hospital environment with cytotoxic agents by maintaining the physical integrity and security of the packages of cytotoxic drugs is critical Access to area of storage is limited to authorized personnel only Storage of cytotoxic drugs shall be limited to a specific area designated with warning labels "CAUTION: CHEMOTHERAPY" posted. Shelves shall have bins with front barriers and stored at eye level or lower to reduce the chance of drug containers falling to the floor and breaking Damaged shipping cartons containing cytotoxic drugs shall be opened in an isolated area wearing appropriate protective equipment (double gloves, goggles, and respiratory mask) The delivery of cytotoxic agents from the pharmacy to the nursing units shall be hand delivered to reduce the chance of accidental breakage in public areas of the hospital. Pneumatic tube system or courier service shall NOT be used The return of unused antineoplastic agents to the pharmacy from the nursing units shall be collected by pharmacy personnel and disposed of in the plastic, puncture resistant containers labeled "CHEMOTHERAPY WASTE". 3. Staff orientation, training, education, and competency assessment: 3.1. The Director of Pharmaceutical Services is responsible for ensuring that pharmacy personnel authorized to prepare and dispense chemotherapy complete formal orientation, training, and education as well as competency assessment as described below Pharmacy personnel are required to undergo an orientation program, testing, and certification. Page 1 of 7

2 Pharmacy personnel must receive educational and/or in-service training when new chemotherapy agents are added to the formulary or used in investigational chemotherapy protocols Pharmacy personnel must undergo IV competency assessments at least annually in order to assess and identify areas for improvement Pharmacy-Nursing Collaboration: The Executive Director of Pharmaceutical Services shall collaborate with nursing administration to ensure that nursing orientation programs, competency assessments, and in-services on safe chemotherapy handling are provided for the nursing staff Medication Reference Resources: Organization-Specific: The Executive Director of Pharmaceutical Services shall ensure that reference resources such as copies of Chemotherapy protocols and research drug protocols are readily available to staff in the pharmacy General Resources: Concepts in Oncology therapeutics ASHP Handbook on injectable drugs 10 th Ed., L.A. Trissel 4. Requirements for Prescribing Chemotherapy: 4.1. Chemotherapy intended to treat a cancer diagnosis must be ordered using an approved Physician Order Form, approved UNM Cancer Center form, or approved electronic order. Electronic orders intended to treat a cancer and non-cancer diagnoses may only be entered for the current cycle. Future cycles may only be entered after the prior cycle has been completed Basic requisites for prescribing chemotherapy: Drug name Complete, approved generic drug names should be utilized (abbreviations shall not be used) Only specific formulary approved drug names are acceptable Dosage When possible, dosage should be expressed in dose per body weight or body surface area and total dose. For example, Cisplatin 80 mg/m2=128 mg Diluent name and volume Route of administration: The route of administration should be specified as either oral, IV push, continuous IV infusion, or IVPB Instructions for administration must include duration of infusion Administration sequence and exact timing Number of doses to be administered, treatment duration, or date Start date and cycle days that drug is to be administered when treatment is to be discontinued. If ordered electronically orders may need to be entered with the frequency of once then discontinue with a specific date, time and cycle day Verbal or telephone orders for initiation of chemotherapy shall not be accepted under any circumstances Orders for chemotherapy should not be written each day as a separate order when using Mosaic or handwritten. Instead, the regimen should be written in its entirety as one order Orders entered electronically may be entered each day as separate orders using a UNMH approved Cerner electronic order. Page 2 of 7

3 4.5. Trailing zeros should be avoided in writing all drug orders, especially chemotherapy orders The preferred route for IV infusions of vesicants is via a central line The attendant disease state, diagnosis, or indication should be made available to all healthcare providers either through the electronic medical record or on the order The title of the clinical trial or treatment protocol used as the basis for treatment should be readily available to the pharmacy staff. All working protocols should be maintained and available to all staff responsible for preparing and dispensing such orders Prescribing of chemotherapy shall be limited to appropriately credentialed and privileged Medical Staff as determined by the Medical Staff appointment and reappointment process Appropriately-privileged Medical Staff can order, initiate, clarify, modify, change and cancel any orders for chemotherapy for which they are privileged Fellows under the guidance of their appropriately-privileged attending can order, initiate, clarify, modify, change and cancel any orders for chemotherapy. 5. Requirements for Preparation 5.1. Chemotherapy shall only be handled and prepared by pharmacists and pharmacy technicians that are trained in proper techniques and procedures in compounding these agents. All chemotherapy will be prepared in the pharmacy. All pharmacy personnel will have reviewed instructional materials "Safe Handling of Cytotoxic Drugs", by ASHP prior to working with these agents. All hospital employees must be informed of the potential hazards of these agents before handling them. Material Safety Data Sheets (MSDS) will be maintained on each of these agents and will be readily available All mixing of chemotherapy shall be done in the vertical laminar-flow containment hood, Class II, Type B, Biological Safety Cabinet (BSC). The view screen (glass) shall be in proper position when the cabinet is in use. The hood shall be kept running 24 hours a day. The vent fan shall be kept running 24 hours a day. The BSC will be cleaned every morning using appropriate technique, with water and then with 70% isopropyl alcohol. Once weekly, the BSC will be decontaminated and surface cleaned with 70% isopropyl alcohol. This will include the bottom sump and work surface The work area shall be prepared according to internal pharmacy procedures based on USP 797 guidelines All materials to be used shall be assembled prior to mixing. The technician shall not leave the work area once preparation has begun Chemotherapy approved gloves and a closed-front, long-sleeved gown of low permeability fabric, with knit cuffs must be worn during preparation. Cuffs of the glove shall be pulled over the gown so that no skin will be exposed. Respiratory masks and goggles may also be worn to prevent inhalation and contact with the eyes. Gloves and gown shall not be worn outside the preparation area to avoid contamination of the other areas and employees. Protective garb will be discarded at the end of each batch Smoking, eating, or drinking in the area of preparation is prohibited Employees who are pregnant, actively trying to conceive, or who are breast-feeding may be excused from handling chemotherapy. 6. Preparation of chemotherapy if BSC is not operable 6.1. This procedure shall be used ONLY if the BSC is not functioning due to breakdown or contamination Use a clean counter top in the IV area or the horizontal flow hood with the blower turned off. Page 3 of 7

4 All previously listed preparation procedures shall be followed when preparing chemotherapy as listed above All unnecessary personnel shall be evacuated from the area All appropriate protective equipment must be worn (gloves, gown, goggles, and respiratory mask). 7. Requirements for compounding chemotherapy 7.1. Commonly acceptable aseptic preparation techniques for chemotherapy must be used when compounding Access to compounding area should be limited to necessary personnel Hands must be washed thoroughly before and after preparation Care must be taken to avoid puncturing the gloves and possible contamination A disposable plastic-backed liner will be spread on the work surface to absorb any spilled drug solution Syringes and IV sets with Luer-lock fittings shall be used to avoid possible leakage Wrap pads around the neck of ampules to prevent aerosolization and injury when breaking open ampules Vials should not be vented (use chemo pin). Negative pressure should be maintained inside vials to prevent "blow-back" or aerosols of cytotoxic agents Excess solution should be expelled back into the vial or an empty vial and labeled as chemotherapy waste Needles will be placed in a puncture resistant disposal container. Do NOT clip needles Bags or bottle shall be wiped clean of drug contamination and placed in a zip-lock bag before removing from preparation area. Caution labels will be attached to the preparation and to zip-lock bags (CAUTION: DISPOSE OF PROPERLY, CHEMOTHERAPY) All contaminated items, gloves, disposable gowns, syringes, vials, needles, liners, etc., shall be placed in a large plastic zip-lock bag and placed in the cytotoxic disposal container Wipe the hood clean with water, then the 70% alcohol after preparation completed. 8. Basic Requisites for Order Processing and Checking of Chemotherapy 8.1. Prior to dispensing chemotherapy, the chemotherapy order, calculations, preparation, and labeling must be double checked by two pharmacists or a pharmacist and a chemotherapy certified pharmacy technician. The chemotherapy is also reviewed by nursing staff against the original order prior to administration. This includes: BSA calculations are correct Dosing for children under one year of age may be based upon kilogram weight rather than BSA The total dose for the prescribed cycle is correct and does not exceed the recommended maximum dose per cycle. Five distinct types of dosage limits apply: Maximum amount for a single dose Maximum amount per 24 hours Maximum amount per total course of therapy Maximum amount per patient lifetime Maximum and/or minimum infusion duration for various doses (e.g. high dose cytarabine > 1gm/m2 are not infused over more than six hours) A check for appropriate diluents and duration A check for patient allergies and drug-drug interactions A check for route of administration (i.e., intravenous, intra-arterial, intrathecal, intraperitoneal, and intrabladder) Vesicants are administered IV push in a syringe in the absence of a central venous access line. For a list of cytotoxic agents associated with extravasation injury see Attachment A The following checks / verifications should also be made to assure that: Page 4 of 7

5 The chemotherapy regimen is appropriate for the diagnosis Infusion times are adjusted to minimize the risk of adverse reactions The order for chemotherapy is clarified for sequence-dependent regimens. For example, leucovorin is given before fluorouracil in colon cancer All intrathecal chemotherapy are prepared with preservative-free diluents and mixed as close as possible to the administration time to assure sterility Appropriate pre-medications or test doses are ordered and/or patients have been appropriately pre-medicated prior to start of chemotherapy Appropriate antiemetic agents are ordered prophylactically for moderately and highly emetogenic chemotherapy regimens such as cisplatin, cyclophosphamide, dacarbazine, ifosfamide Appropriate hydration is ordered for patients receiving potentially renal- or bladder-toxic drugs such as cisplatin, ifosfamide, pentostatin, streptozocin, cisplatin, or high dose cyclophosphamide or methotrexate Chemoprotectant agents are ordered and administered appropriately based on the pharmacokinetics of the drugs being administered. Prior to admixing chemotherapy, the oncology pharmacist will ensure that chemoprotective agents are readily available Post-medications are ordered appropriately Final concentrations of prepared products are appropriate and ensure the stability of the solution Extravasation policies are in place and kits for managing such situations shall be maintained and readily available Material Safety Data Sheets are available for the majority of chemical subsection of the Material Safety Data Sheet under ' environmental protection procedures' describes the method for deactivating antineoplastic agents before disposal. 9. Dispensing of chemotherapy: 9.1. The prepared chemotherapy will be dispensed in a timely manner upon receipt of physicians order based on the time indicated for administration All chemotherapy preparations shall be identified as such via the appropriate warning labels (CHEMOTHERAPY DRUG-CAUTION: DISPOSE OF PROPERLY) All chemotherapy will be placed into a suitably sized, sealed zip-lock bag and will be labeled with the aforementioned warning label Oral agents will be dispensed in unit dose packaging or in suitable amber prescription vials labeled with the appropriate warning labels. SUMMARY OF CHANGES Updated prescribing of chemotherapy to allow for electronic orders Added attachment A Updated to requirements for compounding to reflect current practice RESOURCES/TRAINING Pharmacy Resource/Dept Contact Information DOCUMENT APPROVAL & TRACKING Item Contact Date Approval Owner Executive Director, Pharmaceutical Services Richard D Angio, PharmD, Director of Clinical Pharmacy Services; Scott Roach, PharmD, Consultant(s) Director Pharmacy Operations; Shawn McConkey PharmD, Matthew London PharmD Inpatient Pharmacy Supervisors. Page 5 of 7

6 Committee(s) Pharmacy & Therapeutics Committee, UNMH PP&G Committee Nursing Officer Sheena Ferguson, Chief Nursing Officer N/A Medical Director Wilmer Sibbit, MD, Medical Director, Pharmacy Y Official Approver Administrator, Professional Services Y Official Signature On SharePoint Date: 8/16/2017 Effective Date 8/16/2017 Origination Date 7/1991 Y Page 6 of 7

7 Attachment A The following agents are considered vesicants: 1. carmustine 2. dacarbazine 3. dactinomycin 4. daunorubicin 5. daunorubicin liposomal 6. doxorubicin 7. doxorubicin liposomal 8. epirubicin 9. idarubicin 10. mechlorethamine 11. melphalan 12. mitomycin 13. mitoxantrone 14. plicamycin 15. streptozocin 16. vinblastine 17. vincristine 18. vinorelbine Page 7 of 7

British Columbia Cancer Agency

British Columbia Cancer Agency Page 1 of 12 A. SCOPE This Policy covers the preparation, administration, and disposal of hazardous drugs. See Cancer Drug Manual Appendix 5 for the Hazardous Drug List. (www.bccancer.bc.ca/hpi/drugdatabase/appendices)