Download Chemotherapy Procedure

Applies To: UNM Hospitals
Responsible Department: Pharmacy
Revised: 2/2017
Procedure
Title: Chemotherapy
Patient Age Group:
( ) N/A
(X) All Ages
( ) Newborns
( ) Pediatric
( ) Adult
DESCRIPTION/OVERVIEW
The 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, a standard procedure for
prescribing, preparing, storing, dispensing, administration and monitoring these agents needs to be
maintained at all times.
REFERENCES
American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs.
Am J Health-Syst Pharm. 2006; 63:1172-93
AREAS OF RESPONSIBILITY
All UNMH operating units where chemotherapy is utilized; The UNMH Pharmacy and
Therapeutics Committee; Department of Pharmaceutical Services; UNMCC.
PROCEDURE
1. The Executive Director of Pharmaceutical Services 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.
2.1.1 Area of storage is limited to authorized personnel only.
2.1.2 Storage of cytotoxic drugs shall be limited to a specific area designated with
warning labels "CAUTION: CHEMOTHERAPY". These 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.
2.1.3 Damaged shipping cartons containing cytotoxic drugs shall be opened in an isolated
area wearing protective garb (double gloves, goggles, and respiratory mask, gown ).
2.1.4 The delivery of cytotoxic agents from the pharmacy to the nursing units shall be hand
delivered or placed on the lift by pharmacy personnel to reduce the chance of
accidental breakage in public areas of the hospital. Pneumatic tube system or courier
service shall NOT be used.
2.1.5 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 Executive 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.
3.1.1. Personnel are required to undergo an orientation program, testing, and certification.
3.1.2. Personnel must receive educational and/or in-service training when new chemotherapy
_______________________________________________________________________________________________________________
Title: Chemotherapy
Owner: Pharmacy Services
Effective Date: 4/6/2017
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agents are added to the formulary or utilized in investigational chemotherapy protocols.
3.1.3. Personnel must undergo competency assessments at least annually in order to assess and
identify areas for improvement.
3.2. Pharmacy-Nursing Collaboration
3.2.1 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.
3.3. Reference Resources
3.3.1 Organization-Specific
3.3.1.1 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.
3.3.2 General
3.3.2.1 Concepts in Oncology therapeutics – ASHP 2009
3.3.2.2 Handbook on injectable drugs – 19th Ed., L.A. Trissel
4. Requirements for Prescribing Chemotherapy
4.1. All chemotherapy orders must be written on a Physician Order Form or approved UNM Cancer
Center form.
4.2. Basic requisites for prescribing chemotherapy:
4.2.1.Drug name
4.2.1.1. Complete, approved generic drug names should be utilized (abbreviations
should be avoided).
4.2.1.2. Only specific formulary approved drug names are acceptable.
4.2.2. Dosage
4.2.2.1. 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.
4.2.3. Diluent name and volume
4.2.4. Route of administration
4.2.4.1 The route of administration should be specified as either “oral,” “IV push,”
“continuous IV infusion,” or “IVPB.”
4.2.5. Instructions for administration
4.2.5.1. Rate of administration
4.2.5.2. Duration of infusion
4.2.6. Administration sequence and exact timing
4.2.7. Number of doses to be administered, treatment duration, or date
4.2.8. Start date and cycle days that drug is to be administered when treatment is to be
discontinued.
4.2.9.Total amount of drug to be administered per course of treatment.
4.2.9.1 Example A: Drug ABC 10mg/m2/dose=20mg in 100ml of 5% dextrose
injection; infuse intravenously over 24 hours every 48 hours for three doses
starting on day 1. Start at 1400 on January 5, 1999 (day 1, 3, and 5; total dose
per cycle 30mg/m2=60mg).
4.2.9.2 Example B : Drug ABC 8mg/m2=16mg per day for three days in 150ml of
0.9% sodium chloride injection, by continuous intravenous infusion starting on
day 1. Start on 4/1/1999 at 0800 (total dose=24mg/m2=48mg over 72 hours;
total dose mixed in one container).
4.3. Verbal or telephone orders for chemotherapy shall not be accepted under any
circumstances.
_______________________________________________________________________________________________________________
Title: Chemotherapy
Owner: Pharmacy Services
Effective Date: 4/6/2017
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4.4. Written or faxed orders shall be utilized in lieu of verbal orders.
4.5. Orders for chemotherapy should not be written each day as a separate order. Instead, the
regimen should be written in its entirety as one order.
4.6. Trailing zeros should be avoided in writing all drug orders, especially chemotherapy orders.
4.7. The preferred route for IV infusions of vesicants is via a central line.
4.8. 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.
4.9. 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 in a
notebook and available to all staff responsible for preparing and dispensing such orders.
4.10. Prescribing of chemotherapy shall be limited to appropriately credentialed and
privileged Medical Staff as determined by the Medical Staff appointment and
reappointment process.
4.10.1 Appropriately-privileged Medical Staff can order, initiate, clarify, modify, change and
cancel any orders for chemotherapy for which they are privileged.
4.10.1.1 Only attending physicians can approve cycle 1 day 1 chemotherapy orders.
4.10.1.2 Fellows under the guidance of their appropriately-privileged attending can
order, initiate, clarify, modify, change and cancel any orders for
chemotherapy except cycle 1 day 1 chemotherapy orders.
4.10.1.3 Mid-levels are certified to approve, modify doses and hold
chemotherapy orders under the authority of the attending physician.
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.
5.2. The work area shall be prepared according to internal pharmacy procedures based on USP 797
guidelines.
5.3. All materials to be used shall be assembled prior to mixing. The pharmacist shall not leave the
work area once preparation has begun.
5.4. 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.
5.5. Smoking, eating, or drinking in the area of preparation is prohibited.
5.6. Employees who are pregnant, actively trying to conceive, or who are breast-feeding may be
excused from handling chemotherapy.
6. Requirements for compounding chemotherapy
6.1. An IV Pharmacy Chemotherapy Preliminary Checklist will be maintained, per patient, to record
patient name and MR number, date of admission, diagnosis, allergy information, Ht, Wt, BSA,
questions to answer that aid in initial trouble shooting, and documentation of an inventory
check to assure availability of medications for the complete course of therapy.
6.2. An IV Patient Profile will be generated and maintained on an individual patient basis. This
serves as a compounding worksheet for chemotherapy admixture personnel. It also serves as a
reference and added safety check for subsequent treatments.
_______________________________________________________________________________________________________________
Title: Chemotherapy
Owner: Pharmacy Services
Effective Date: 4/6/2017
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6.3. An individual patient folder will be created and the IV Pharmacy Chemotherapy Preliminary
Check Sheet, the IV Patient Profile, copies of protocols or other pertinent information, and the
original orders will be placed inside. This folder will be filed under the corresponding day of
the week for the next doses admixture and administration. Once the chemotherapy course is
completed, the folder is to be filed in the chemotherapy filing cabinet.
6.4. Commonly acceptable aseptic preparation techniques for chemotherapy must be used when
compounding.
6.5. Access to compounding area should be limited to necessary personnel.
6.6. Hands must be washed thoroughly before and after preparation.
6.7. Care must be taken to avoid puncturing the gloves and possible contamination.
6.8. A disposable plastic-backed liner will be spread on the work surface to absorb any spilled
drug solution.
6.9. Syringes and IV sets with Luer-lock fittings shall be used to avoid possible leakage.
6.10. Wrap pads around the neck of ampules to prevent aerosolization and injury when breaking
open ampules.
6.11. Vials should not be vented (use chemo pin). Negative pressure should be maintained
inside vials to prevent "blow-back" or aerosols of cytotoxic agents.
6.12. Excess solution should be expelled back into the vial or an empty vial and labeled as
chemotherapy waste.
6.13. Needles will be placed in a puncture resistant disposal container. Do NOT clip needles.
6.14. 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).
6.15. 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.
6.16. Wipe the hood clean with water, then the 70% alcohol after preparation completed.
7. Basic Requisites for Order Processing and Checking of Chemotherapy
7.1. 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:
7.1.1. Body surface area (BSA) calculations are correct.
7.1.2. Dosing for children under one year of age may be based upon kilogram weight rather
than BSA.
7.1.3.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:
7.1.3.1. Maximum amount for a single dose.
7.1.3.2. Maximum amount per 24 hours.
7.1.3.3. Maximum amount per total course of therapy.
7.1.3.4. Maximum amount per patient lifetime.
7.1.3.5. Maximum and/or minimum infusion duration for various doses (eg high dose
cytarabine > 1gm/m2 are not infused over more than six hours).
7.1.4. A check for appropriate diluents and duration
7.1.5. A check for patient allergies and drug-drug interactions
7.1.6. A check for route of administration (i.e., intravenous, intra-arterial, intrathecal,
intraperitoneal, and intrabladder)
7.1.7. Vesicants are administered IV push in a syringe in the absence of a central venous access
line. The following agents are considered vesicants:
7.1.7.1. carmustine
7.1.7.2. dacarbazine
7.1.7.3. dactinomycin
_______________________________________________________________________________________________________________
Title: Chemotherapy
Owner: Pharmacy Services
Effective Date: 4/6/2017
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7.1.7.4. daunorubicin
7.1.7.5. daunorubicin liposomal
7.1.7.6. doxorubicin
7.1.7.7. doxorubicin liposomal
7.1.7.8. epirubicin
7.1.7.9. idarubicin
7.1.7.10. mechlorethamine
7.1.7.11. melphalan
7.1.7.12. mitomycin
7.1.7.13. mitoxantrone
7.1.7.14. plicamycin
7.1.7.15. streptozocin
7.1.7.16. vinblastine
7.1.7.17. vincristine
7.1.7.18. vinorelbine
8.2. The following checks / verifications should also be made to assure that
8.2.1. The chemotherapy regimen is appropriate for the diagnosis.
8.2.2. Infusion times are adjusted to minimize the risk of adverse reactions.
8.2.3. The order for chemotherapy is clarified for sequence-dependent regimens. For example,
leucovorin is given before fluorouracil in colon cancer.
8.2.4. All intrathecal chemotherapy are prepared with preservative-free diluents and mixed as
close as possible to the administration time to assure sterility.
8.2.5. Appropriate pre-medications or test doses are ordered and/or patients have been
appropriately pre-medicated prior to start of chemotherapy.
8.2.6. Appropriate antiemetic agents are ordered prophylactically for
moderately and highly emetogenic chemotherapy regimens such as cisplatin,
cyclophosphamide, dacarbazine, ifosfamide.
8.2.7. 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.
8.2.8. 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.
8.2.9. Post-medications are ordered appropriately.
8.2.10. Final concentrations of prepared products are appropriate and ensure the stability of
the solution.
8.2.11.Extravasation policies are in place and kits for managing such situations shall be
maintained and readily available.
8.2.12. 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.
9.2. Chemotherapy dispensed in a syringe shall not be more than 3/4 full and will be secured
via a luer-locking cap.
9.3. All chemotherapy preparations shall be identified as such via the appropriate warning labels
(CHEMOTHERAPY DRUG-CAUTION: DISPOSE OF PROPERLY ). See attached sample.
_______________________________________________________________________________________________________________
Title: Chemotherapy
Owner: Pharmacy Services
Effective Date: 4/6/2017
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9.4. All chemotherapy will be placed into a suitably sized, sealed zip-lock bag and will be labeled
with the aforementioned warning label.
9.5. Chemotherapy ready to be delivered shall be logged in on the Pharmacy Chemotherapy Delivery
and Nursing Receipt Log. Pharmacy personnel shall then deliver all chemotherapy and it will be
signed for by nursing personnel on the “Pharmacy Chemotherapy Delivery and Nursing Receipt
Log” when received.
9.6. Oral agents will be dispensed in unit dose packaging or in suitable amber prescription vials
labeled with the appropriate warning labels.
SUMMARY OF CHANGES
Added Sections 4.10.1. and 4.10.1.1.
Replaces “Chemotherapy” last revised, 9/2009.
RESOURCES/TRAINING
Resource/Dept
Contact Information
Pharmacy
DOCUMENT APPROVAL & TRACKING
Item
Nursing Officer
Medical Director
Official Approver
Contact
Date
Approval
Executive Director, Pharmaceutical Services
Richard D’Angio, PharmD, Director of Clinical Pharmacy Services; Scott Roach, PharmD,
Director, Oncology Service; William Long, PharmD, Director Pharmacy Operations;
Pharmacy & Therapeutics Committee, Clinical Operations PP&G
Y
Committee, Nursing PP&G Subcommittee
Sheena Ferguson, Chief Nursing Officer
N/A
Medical Director, Pharmacy
Y
Administrator, Professional & Support Services
Y
Official Signature
Michael Chicarelli (signed by SharePoint)
Owner
Consultant(s)
Committee(s)
Effective Date
Origination Date
Issue Date
Date: 4/6/2017
4/6/2017
7/1991
Clinical Operations Policy Coordinator
_______________________________________________________________________________________________________________
Title: Chemotherapy
Owner: Pharmacy Services
Effective Date: 4/6/2017
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