MCG Health, Inc. Policy Number 14.144 Patient Care Services

MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 1 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
Intent:
To define policy, provide consistency and to establish safeguards for the prescribing, preparing,
dispensing, transporting, administering, and monitoring and educating patients regarding
antineoplastic agents.
Scope:
This policy applies to all healthcare workers involved with antineoplastic agents.
Policy:
All antineoplastic agents prescribed for MCGHI patients will be processed according to the
following provisions to ensure accuracy and safety in prescribing, preparing, dispensing,
transporting, administering, and monitoring.
Definitions:
Antineoplastic medication – any medication used in the direct treatment of cancer. Biological
agents and chemotherapy are considered antineoplastic medications.
Biological – A substance that is made from a living organism or its products and is used in the
prevention, diagnosis, or treatment of cancer and other diseases. Biologic agents include
antibodies, interleukins, and vaccines.
Chemotherapy – any medication used in the direct treatment of cancer or autoimmune
disorders that produces its effects via a cytotoxic mechanism.
Hazardous medication – any medication that is known or suspected to cause adverse health
effects from exposures in the workplace. A medication is classified as hazardous if it shows one
or more of the following characteristics in humans or animals:
A. Carcinogenicity
B. Teratogenicity or developmental toxicity
C. Reproductive toxicity
D. Organ toxicity at low doses
E. Genotoxicity
F. Structure and toxicity profiles of new medications that mimic existing medications
determined hazardous by the above criteria.
Hormonal medication – any medication whose mechanism of action involves agonist or
antagonist actions for hormones, such as testosterone, estrogen, or progestins. Tamoxifen is a
hormonal medication used for the treatment of cancer. Hormonal agents will not be considered
antineoplastic agents for the purposes of this policy.
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 2 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
Provisions
I.
Prescribing:
A. The prescribing of antineoplastic agents is restricted to physicians experienced in
the use of these agents.
B. Informed consent will be obtained from patient prior to all first cycles of new
antineoplastic regimens, as well as any time a modification to the regimen is required.
1. The following treatments are exempt from informed consent
a) Hormonal therapy
b) Continuation of hydroxyurea when used in the treatment and
maintenance of Sickle Cell Anemia
2. Informed Consent will be documented using the Informed Consent for
Surgical and/or Diagnostic Procedures Form, unless an alternative, regimen or
research protocol-specific Informed Consent Form is used.
C. Orders for antineoplastic agents are written clearly, concisely, and unambiguously
on the Chemotherapy Order Form.
1. Exceptions to use of the Chemotherapy Order Form are:
a) Pediatric orders which have been calculated through the pediatric
antineoplastic ordersets
b) Hormonal therapy
c) Vaccines
d) Hydroxyurea when used in the treatment and maintenance of Sickle
Cell Anemia
2. A complete order includes
a) Patient name
b) Medical record number
c) Date of birth
d) Diagnosis
e) Allergies
f) Affirmation that informed consent has been obtained for the first
cycle of a regimen. If a change in regimen is made, new consent must be
obtained.
g) Height in centimeters
h) Weight in kilograms
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 3 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
i)
Body surface area (BSA), when indicated
j)
Regimen name
k) Non-abbreviated medication name
l)
Cycle number
m) Protocol or reference, when indicated
n) Therapy start date
o) Adjunctive/supportive care medications related to antineoplastic
agents
p) Prescribed antineoplastic medication dose and units (for example:
dose/m2, dose/kg, or AUC)
q) Actual calculated antineoplastic medication dose
r) Total lifetime anthracycline dose, if anthracycline used as part of
regimen
s) Route of administration
t) Directions for administration, if applicable (e.g. rate of
administration, time over which medication is to be infused)
u) No unapproved abbreviations
v) Pertinent laboratory values specific to antineoplastic regimen and/or
diagnosis
w) Lab values acquired within 7 days of treatment may be used to
initiate antineoplastic therapy without having to redraw labs on the day
of initiation, unless otherwise directed by regimen or protocol.
x) Date and time order was written
y) Printed name of provider writing order
z)
Signature of writer of order (see below)
aa) Attending physician printed name, signature pager number, date and
time.
3. Calculations used for the determination of chemotherapy doses will be
determined through the use of the following applicable equations unless
otherwise specified by official protocol.
a) BSA:
Mosteller Equation
BSA (m2) = [ Ht(cm) * Wt(kg) / 3600 ]½
b) Creatinine Clearance:
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 4 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
Cockroft & Gault (Adults)
men: CrCl = [(140 - age) x IBW] / (Scr x 72)
wom:
CrCl = {[(140 - age) x IBW] / (Scr x 72) } * 0.85
Swartz (Pediatric)
CrCl (ml/min/1.73m2)= [length (cm) x k] / Scr
k = 0.45 for infants 1 to 52 weeks old
k = 0.55 for children 1 to 13 years old
k = 0.55 for adolescent females 13-18 years old
k = 0.7 for adolescent males 13-18 years old
c) Ideal Body Weight:
Devine Formula
men: Ideal Body Weight (in kilograms) = 50 + 2.3 kg per inch over 5 feet.
wom: Ideal Body Weight (in kilograms) = 45.5 + 2.3 kg per inch over 5 feet
d) Adjusted Body Weight:
ABW (kg) = ideal body weight + [0.4 * (actual body weight - ideal body weight)]
e) Carboplatin Dosage based upon AUC
Calvert Formula
Total Dose (mg) = (target AUC) x (GFR + 25)
**GFR: Glomerular Filtration Rate (Creatinine Clearance)
4. Fellows are permitted to write orders for antineoplastic agents under the
direct supervision of the attending physician.
5. Attending physician will not co-sign the order until all required elements
have been written by the fellow.
a) Initiation of the order does not occur until the order is co-signed by
attending physician.
6. Nurse practitioners that have been granted the authority by medical staff to
write orders for antineoplastics are permitted to write for antineoplastic agents
under the direct supervision of attending physician.
7. Personnel specifically not listed above, including nurses and pharmacists,
are prohibited from writing chemotherapy orders.
8. Attending physicians specializing in practices other than hematology and
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 5 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
oncology may prescribe antineoplastic agents within the scope of their specialty.
9. Except when discontinuing antineoplastic agents, telephone orders, (both
new orders and changes to regimens) are not accepted by staff nurses.
a) For pediatric patients, changes in the infusion rate may be accepted
via telephone by staff nurses. These orders will be co-signed by the
attending physician within 24 hrs.
b) Pharmacists may clarify antineoplastic orders via telephone with the
attending physician in accordance with policy PH02.04, “Medication
Order Clarification” and reference the clarification form to the original
order.
c) Orders in need of change will be rewritten by attending physician per
the above provisions.
10. Pharmacy requires a written order on an approved order form before
dispensing antineoplastic agents. When orders are received on non-approved
forms, the pharmacist will contact the prescriber and request the orders on an
approved form.
11. Orders will be submitted to pharmacy at least 24 hours in advance of a
patient’s planned treatment as an inpatient.
a) Exceptions to this include pediatric cancer patients and situations
deemed an emergency.
12. The antineoplastic order cut-off time is 1200 (noon) for inpatients and 1530
for outpatients.
a) Orders received after this time will be initiated the following day to
ensure patient safety.
b) For outpatients, the antineoplastic order cut-off time for infusions
requiring more than 2 hrs to administer is 1200 (noon).
c) Exceptions to this are situations deemed a life-threatening emergency
(e.g. blast crisis, rapidly progressing lymphomas, superior vena cava
syndrome).
II. Preparing and Dispensing:
A. Antineoplastic agents are prepared and dispensed by the Department of Pharmacy.
B. Two pharmacists (or a pharmacist and an antineoplastic trained nurse) will review:
1. Appropriateness of drug, dosage, and route of administration based on the
patient’s condition (such as, but not limited to renal function, hepatic function,
age, weight, BSA)
2. Known allergy or hypersensitivities or adverse drug reactions
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 6 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
3. Potential interactions with other medications
4. Potential contraindications
5. Compatibility and stability
6. Appropriate concurrent medications
C. The pharmacist will review and query the pharmacy patient profile system for the
patient’s prior hospital antineoplastic treatment history and compare current orders
with previous cycles, regimens, and published references.
1. The pharmacist discusses variances in dose, duration of therapy, omitted
and/or additional medications with the prescribing physician when clinically
indicated.
2. Orders in need of change will be rewritten by attending physician per the
above provisions.
D. To decrease the use of partial vials and expedite the checking and dispensing
process, the pharmacist, without contacting the prescriber, may:
1. Round the antineoplastic dose within 5% of the original order. Exceptions to
this will be
a) When rounding is not allowed per research protocol
b) When a physician writes “do not round dose”
2. Change the base solution and volume of solution based upon the protocol or
reference, drug stability, and infusion guidelines listed in the package insert or
medical literature
3. The pharmacist will make the above changes, complete a physician order
clarification form citing the reasons why the change(s) were made and send this
clarification form with the final chemotherapy product. This clarification form
will be referenced on the original chemotherapy order using the phrase “see
pharmacist clarification”, and will be maintained with the chemotherapy orders
in the patient’s medical record.
E. A pharmacy technician or pharmacist will prepare the antineoplastic medication
according to the Pharmacy’s Compounded Sterile Products policies and procedures
F. If oral antineoplastic agents are to be manipulated from their original dosage form
(i.e. crushing of tablets, opening of capsules), the process must be done in a biological
safety cabinet to prevent inhalation exposure.
G. The pharmacy technician or pharmacist will record the lot number and expiration
date of the antineoplastic being dispensed on the patient specific inpatient
antineoplastic worksheet or the outpatient patient profile.
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 7 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
H. For preparation and dispensing of intrathecal medications, refer to pharmacy policy
Preparation and Dispensing of Intrathecal Medications PH.17.01
I. The pharmacist will double check the final product against the antineoplastic order
before dispensing.
J. Label antineoplastic medications appropriately with patient information label and
ancillary antineoplastic (chemotherapy) precaution labels
K. Delivery of antineoplastic medications from pharmacy
1. Pharmacy will place all antineoplastic medications in plastic sealable
(Ziplock) bag with an outside handwritten label containing patient’s name and
location
2. Pharmacist will initial the transport bag’s outer label to indicate he/she has
matched the patient name on the final product with the outside label of the
transport bag.
3. The pneumatic tube system is not to be used to deliver antineoplastic
medications.
III. Transportation of antineoplastic agents
A. Individuals involved in the transportation of antineoplastic agents will receive
education and training appropriate to their job duties.
B. Used antineoplastics will be sealed in a plastic bag before being transported out of
the patient room per Chemotherapy Handling and Waste Management Procedure C.31.0
IV. Administration
A. Determine the availability of Chemotherapy Spill Kit prior to antineoplastic
administration per Chemotherapy Handling and Waste Management Procedure C.31.0
B. Medical students, interns, and residents will not administer antineoplastic agents.
C. Physician Assistants and Clinical Nurse Practitioners may administer
antineoplastics if they have documented training and their credentials support
administration of these agents.
D. Hematology and oncology attending physicians and other attending physicians,
within the scope of their specialty and practice, may administer antineoplastic agents.
E. Hematology and oncology fellows and other fellows, within the scope of their
specialty and practice, may administer antineoplastic agents under the supervision of
their attending physician.
F. Intrathecal antineoplastic agents may only be administered by attending physicians,
fellows, physician assistants, and clinical nurse practitioners, if it is within the scope of
their specialty and practice and they are credentialed in this administration technique.
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 8 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
1. Prior to intrathecal administration, the person administering will:
a) Perform a Time Out procedure per Policy 14.112, “Side, Site,
Procedure Verification” (e.g. Universal Protocol Procedure)
b) Complete the Intrathecal Medication Administration Time Out sticker
provided by pharmacy and place on Staff Note in the patient’s chart.
c) Ensure that only the medications needed for the procedure are in the
sterile field.
G. Nurses who have completed training and have been deemed competent may
administer antineoplastic agents.
1. For adult patients, Registered Nurses (RNs) or Licensed Practice Nurses may
administer these agents per Nursing/Patient Care Services Policy C.26.0
“Chemotherapy Administration Education Policy.”
2. For pediatric patients, only those nurses who pass the Pediatric
Chemotherapy Certification Course and demonstrate continued competency may
administer antineoplastics.
H. When administering antineoplastic agents in non-oncology areas:
1. The antineoplastic trained nurse will initially administer, monitor, and
educate the patient and will communicate with, educate, and collaborate on
future doses with the non-antineoplastic trained nurse.
2. The non-antineoplastic trained nurse will complete the appropriate nursing
assessment and make this available to the antineoplastic trained nurse.
3. The non-antineoplastic trained nurse will monitor the patient for side effects
and therapeutic response.
I.
Administration guidelines
1. Two antineoplastic trained nurses will cosign the Chemotherapy Order Form
to indicate that the following items have been double checked and evaluated
prior to administration of the first dose of each chemotherapy medication.
a) BSA based upon most recently recorded height and weight
b) Physician’s order and calculations of medication doses
c) Appropriate line placement based on antineoplastic agents that are to
be administered
d) Current laboratory values
(1) Lab values acquired within 7 days of treatment may be used to
initiate antineoplastic therapy without having to redraw labs on the
day of initiation, unless otherwise directed by regimen or protocol.
(2) An exception to this will be in pediatric patients who will have
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 9 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
laboratory values checked prior to administration of
antineoplastics.
2. Administering nurse will then
a) Obtain prepared medication from pharmacy or designated
chemotherapy storage location on patient care unit
b) Verify doses dispensed by pharmacy against the order and any
clarifications, if applicable, for accuracy of drug, dose, route, base
solution and volume and dosing schedule
(1) Two nurses will verify each antineoplastic dose against the
order and pediatric road map, if applicable.
c) Provide patient/family education including medication side effects
(1) In the adult outpatient clinic, a pharmacist may provide the
education.
d) Identify patient before administering medications
e) Administer pre-medication if ordered
f) Utilize personal protective equipment with the handling and disposal
of cytotoxic and hazardous medications per Chemotherapy Handling and
Waste Management Procedure C.31.0
g) For parenteral antineoplastics
(1) Flush the line with the appropriate diluent to assess patency
and observe for any signs/symptoms of infiltration.
(2) Vesicant agents that are infused for longer than 30-60 minutes
are only administered through a central venous catheter.
(3) Vesicants administered via continuous infusion will not be
administered through a peripheral intravenous site.
(4) Immediately notify physician if infiltration occurs
(5) Provide appropriate intervention for extravasation of
medication, per Appendix A (Management of Extravasation)
h) For oral antineoplastics
(1) Contact pharmacy if medication is to be crushed or split per the
above Preparing and Dispensing criteria.
(2) Wear gloves when handling and administering antineoplastics
(3) Dispose of any unused/partial doses in the appropriate waste
container
3. Post-administration
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 10 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
a) Antineoplastic/hazardous medication precautions regarding blood
and body fluids are implemented during and continue for 48 hours post
administration per Chemotherapy Handling and Waste Management
Procedure C.31.0
V. Monitoring
A. The prescribing physician is responsible for ensuring critical laboratory and test
results and a medical history are available to health care providers prior to
administration of antineoplastic agents and also during treatment courses.
B. The patient’s nurse will monitor the site of infusion and document time and
assessment of patient as performed.
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 11 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
Appendix A
MCG Health System
Management of Extravasation
Vesicant: causes blistering, phlebitis, flare reactions, and tissue necrosis
Irritant: causes pain, inflammation, burning, and phlebitis without necrosis
Table 1: Vesicants and Irritants
Vesicants
Irritants
Cisplatin (>0.5 mg/mL)
Bleomycin
Dactinomycin
Bortezomib
Daunorubicin
Busulfan
Doxorubicin
Carboplatin
Epirubicin
Carmustine
Idarubicin
Cisplatin (<0.5 mg/mL)
Mechlorethamine
Cladribine
Mitomycin
Cyclophosphamide
Oxaliplatin
Cytarabine
Cytarabine, liposomal
Vinblastine
Dacarbazine
Vincristine
Dexrazoxane
Vinorelbine
Docetaxel
Doxorubicin, liposomal
Etoposide
Etoposide phosphate
Fluorouracil
Gemcitabine
Ifosfamide
Irinotecan
Melphalan
Mitoxantrone
Paclitaxel
Paclitaxel, protein-bound
Streptozocin
Teniposide
Thiotepa
Topotecan
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 12 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
If VESICANT is extravasated…
1.
2.
3.
4.
5.
Stop the infusion immediately.
If possible, withdraw 3-5 mL of blood to remove some of the drug.
Remove the infusion needle.
Apply compress to site for 15 minutes every 6 hours for 48 hours per Table 2.
Elevate for 48 hours above heart level using pillows, a sling or stockinette dressing with
an observation window cut in dressing. Avoid pressure or friction. Do not rub area.
6. Immediately inform the on-call resident, attending physician, chemotherapy nurse (if in
inpatient setting) and chemotherapy pharmacist (pager 5717) of the extravasation.
7. Delineate the infiltrated area on the patient’s skin with a felt tip marker.
8. Document the occurrence in medical record by noting location of erythema and
induration, the size (diameter) of erythematous or blanched area, and presence or
absence of pain or blood return.
9. Observe the wound closely for the next several days for signs of increased erythema,
pain, or skin necrosis. If increased symptoms occur, consult plastic surgeon.
10. After 48 hours, encourage patient to use extremity normally to promote full range of
motion.
If IRRITANT is extravasated…
1.
2.
3.
4.
5.
Stop the infusion immediately.
If possible, withdraw 3-5 mL of blood to remove some of the drug.
Remove the infusion needle.
For etoposide, apply warm compress to site for 15 minutes every 6 hours for 48 hours.
Elevate for 48 hours above heart level using pillows, a sling or stockinette dressing with
an observation window cut in dressing. Avoid pressure or friction. Do not rub area.
6. Immediately inform the on-call resident, attending physician, chemotherapy nurse (if in
inpatient setting) and chemotherapy pharmacist (pager 5717) of the extravasation.
7. Delineate the infiltrated area on the patient’s skin with a felt tip marker.
8. Document the occurrence in medical record by noting location of erythema and
induration, the size (diameter) of erythematous or blanched area, and presence or
absence of pain or blood return.
9. Observe the wound closely for the next several days for signs of increased erythema,
pain, or skin necrosis. If increased symptoms occur, consult plastic surgeon.
10. After 48 hours, encourage patient to use extremity normally to promote full range of
motion.
ANTIDOTES
DMSO 50% for doxorubicin, daunorubicin, mitomycin.
1. Saturate gauze pad.
2. Paint on an area twice the size of the extravasation.
3. Air dry.
4. Repeat every 6 hours for 14 days.
5. Protect extravasation area from sunlight and heat.
MCG Health, Inc.
Patient Care Services
Policy Number 14.144
Page 13 of 13
Rev. 0
Subject: Antineoplastic prescribing, preparing, dispensing, transporting, administering,
and monitoring when used for the treatment of malignancy or indications other than
malignancy (e.g. autoimmune disorders).
Effective:
HYALURONIDASE 150 units/mL for vincristine, vinblastine, vinorelbine.
1. Cleanse area with povidone-iodine.
2. Reconstitute 1 mL vial.
3. Inject locally subcutaneously or intradermally, using 25-gauge needle or smaller.
4. The dose is 5 injections of 30 units (0.2 mL)
SODIUM THIOSULFATE 1/6 molar solution for cisplatin, mechlorethamine.
1. To prepare 1/6 molar solution
a. If using 10% solution, mix 4 mL of sodium thiosulfate with 6 mL of sterile water
for injection.
b. If using 25% solution, mix 1.6 mL of sodium thiosulfate with 8.4 mL of sterile
water for injection.
2. If possible, administer sodium thiosulfate via extravasated IV site or subcutaneously.
3. Mechlorethamine: Use 2 mL of sodium thiosulfate antidote for each 1 mg extravasated.
4. Cisplatin: Use 2 mL of sodium thiosulfate antidote for each 100 mg extravasated.
WARM
Vinblastine
Vincristine
Vinorelbine
Etoposide
Table 2: COMPRESSES
COLD
ICE
Cisplatin
Doxorubicin
Mechlorethamine
Daunorubicin
Mitomycin
Dactinomycin
Idarubicin
Oxaliplatin
Paclitaxel
All other vesicants
References
Facts and Comparisons 4.0, Cancer Chemo Manual, 2005
American College of Clinical Pharmacy, Board Certified Oncology Pharmacists Review Course,
2005
Abraxis Oncology Resource Center, Medical Information, 11/14/2005
Chemotherapy and Biotherapy Guidelines, 2nd Edition. Oncology Nursing Society, 2005
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