Download Who Is Authorized To Prescribe Chemotherapy

February 2013
1
After completing this module, the learner will be able to:
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Describe the process for “Safe Prescribing and
Dispensing of Chemotherapy”
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Identify key responsibilities for each member of the
team caring for patients receiving chemotherapy
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Chemotherapy is a high-risk
medication

It is used to treat malignant and
non-malignant disease states
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Safe prescribing of chemotherapy requires clear orders to allow
the healthcare team to dispense and administer the agents
safely

Healthcare team members may or may not receive education in
their formal training related to safe prescribing and dispensing
of these agents

Chemotherapy – a chemotherapeutic
agent administered for the purpose of
treating malignant and non-malignant
disease states includes:
 Chemotherapeutic agents – traditional cytotoxic agents
such as cyclophosphamide, vincristine, etoposide, paclitaxel
 Immunotherapeutic agents – such as rituximab,
alemtuzumab, aldesleukin
 Targeted therapies – such as cetuximab, imatinib, erlotinib
[Hormonal agents (tamoxifen, bicalutamide, leuprolide) are
excluded]

Your pharmacist is your
greatest resource related to the
classifications of these drugs
Feel free to contact them if you
are unsure if the agent you are
prescribing is considered
chemotherapy

Cancer chemotherapy –
chemotherapeutic
agent administered by any route for
the purpose of treating a malignant
disease state

The dosing of these agents is variable
and has a narrow therapeutic index,
causing increased danger of patient
harm from under or overdosing

This distinction is important when considering:
 Who can prescribe for malignant versus
non-malignant indications
 When patient consent is required

All agents used for cancer treatment regardless
of route must be entered using electronic
ordering systems or follow approved downtime
procedures
 Any attending physician in a designated
department or division who has completed the
Duke Chemotherapy Competency Process
(DCCP), which includes:
 Credentialed to practice at DUH
 Completion of on-line training module “Education for
Prescribing and Dispensing Chemotherapy”
 Completion of Chemotherapy on-boarding (for
prescribing cancer chemotherapy)
 Only attending physicians in the divisions
listed below are authorized to prescribe
cancer chemotherapy for adults:
 Medical Oncology
 Hematology
 Surgical Oncology
 Gynecologic- Oncology
 Neuro-Oncology
 Cellular Therapy
Only attending physicians in the divisions listed
below are authorized to prescribe chemotherapy
for non-malignant indications in adults:
 Cardiology
 Ophthalmology
 Dermatology
 Pulmonary and Critical
 Gastroenterology
Care
 Psychiatry
 Rheumatology
 Urology
 Medicine
 Neurology
 Nephrology
 Obstetrics/Gynecology
Only attending physicians in the divisions
listed below are authorized to prescribe
cancer chemotherapy in pediatrics:
 Divisions of Pediatric HematologyOncology
 Pediatric Neuro-Oncology
 Pediatric Blood and Marrow
Transplantation
Only attending physicians in the divisions listed below are
authorized to prescribe chemotherapy for non-malignant
indications in pediatrics:
 Allergy & Immunology
 Pulmonary and Critical Care
 Cardiology
 Rheumatology
 Dermatology
 Gastroenterology
 Medical Genetics
 Neurology
 Nephrology

Fellows, Physician Assistants (PAs), Nurse Practitioners
(NPs), and Clinical Pharmacist Practitioners (CPPs) are
not authorized to prescribe chemotherapy independently.
 They may write or enter chemotherapy orders after completing the
DCCP and other competency as required by their department
 Orders must be reviewed and signed by an authorized chemotherapy
prescriber

In adult populations only, fellows and other MDs are
authorized to prescribe chemotherapy under the following
conditions:
 Oral chemotherapy for non-malignant indications
 Continuation of chemotherapy regardless of route
All patients receiving cancer chemotherapy - regardless of
route – must be educated and consented prior to initiation of
any new therapy
 Education includes written materials provided to the patient before or
at the time of prescription or administration
 Consent is documented in the medical
record using a standardized consent form
 Consent can be obtained and documented
by an Attending MD, Fellow, PA, NP, CPP
or Registered Nurse (RN)

Prescribing of Chemotherapy For
Non-malignant Indications At Duke
 Patient consent is not required
 All agents used for non-malignant
indications, regardless of route, must
be entered using electronic ordering
systems or follow approved downtime
procedures
Orders
 Available pre-built regimens in the electronic ordering systems
or pre-printed paper order sets must be utilized when ordering
standard cancer chemotherapy regimens and clinical trials
 If not available, the prescriber must include a reference at the
time of order submission
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NCCN practice guidelines
Chemotherapy Sourcebook (Perry)
Chemoregimen.com
Abstracts and case reports are considered on a case-by-case basis
If supporting documentation is not available or if there is disagreement
about provided documentation, the Pharmacy Resolution Process will
be utilized

Verbal Orders for chemotherapy
drugs and doses are not allowed

Verbal orders may be accepted for the
following clarifications and must be documented:
 Holding or stopping chemotherapy
 Administration date changes
 Diluent and administration rate/duration changes
 To clarify when variances of ≥ 10% are present but physician wishes to
proceed
▪ Clarification will read “Day one of chemotherapy will be given as
written, subsequent days of treatment to be rewritten by physician”

Time limitations for Cancer Chemotherapy
 All orders - including oral agents - are
written for one cycle at a time
 For targeted agents only, refills are
acceptable once patient tolerance has
been established

Chemotherapy agents are prescribed using
the generic name of the medication
 Abbreviations and acronyms are not
accepted

No trailing zeros are allowed

Leading zeros must be used for doses
less than one

Decimals are allowed for chemotherapy
to the nearest tenth:
 When doses are less than 10 mg
 In clinical trials where rounding is not
allowed

Patient’s full name and second patient
identifier

Date order written and dates of
administration

Diagnosis

Regimen name and cycle number

Protocol name and eIRB number

Allergies

Appropriate criteria to treat (i.e. lab
values, toxicities or other tests)
 Required labs greater than 2 weeks old are
confirmed with Attending MD, NP, PA or CPP
for all new treatments
 Required labs should be within 24 hours of
treatment for all subsequent treatments
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Dosing Parameters
 Height, weight and Body Surface Area (BSA)
▪ For doses based on weight alone, height and BSA are not required
▪ Weight must be obtained within one week of day one of administration for
new treatments
▪ Weight must be obtained within 24 hours of day one of administration for
subsequent cycles
▪ If using Ideal Body Weight (IBW) or Adjusted Body Weight (ABW), the
order must include the formula used
 Serum creatinine or creatinine clearance for all Area Under the
Curve (AUC)-based agents (as well as formula used)
 When standard, flat, non-parametric doses of chemotherapy are
prescribed, “N/A” will be written in the dose/m2 or kg field

Route and sequence of administration
 Administration duration and diluents
are added by pharmacy per standard
unless otherwise specified by the
prescriber

Supportive care such as:
 Premedications
 Hydration
 Growth factors
 Hypersensitivity medications

Final calculated dose and how the
dose was calculated (Target AUC,
mg/kg, mg/m2, dose/day)

Dosing modifications based on
response or toxicity are documented in
a comment field in the electronic
ordering system or in the special
instructions field if using a paper order
form

Dose rounding rules are built in the electronic ordering
system
 Rules undergo multidisciplinary review

All single use vials of monoclonal antibodies are rounded to
the nearest vial size (up if halfway) by pharmacy, for adults
only
 Order of clarification will be written within 24 hours

No agent in clinical trial regimens will be rounded unless
specifically allowed by the protocol

For paper orders, doses greater than 10 mg are rounded to
the nearest whole number by the prescriber
 Failure to round will require new orders to be written

All orders are reviewed and
signed/approved by an authorized
prescriber
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If written orders were scribed by someone
other than the authorized prescriber,
signature of the person scribing is required

If a regimen or order is to be discontinued,
the orders must be discontinued from
CPOE at the time the decision is made to
hold or stop therapy

All orders are reviewed and signed/approved by an authorized
prescriber
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Hem-Onc-2 signatures (one of which must be the attending)
Neuro-oncology- 1 signature (must be the attending)
BMT-ablative- 2 attending signatures are required
BMT-non-ablative-1 signature (must be the attending)
If written orders were scribed by someone other than the
authorized prescriber, signature of the person scribing is
required
If a regimen or order is to be discontinued, the orders must be
discontinued from CPOE at the time the decision is made to
hold or stop therapy

Pharmacists who have completed the Department of
Pharmacy Chemotherapy Policy Competency Process will
review all chemotherapy orders prior to processing or
implementation

A second pharmacist will perform an independent second
check of the orders before dispensing
 This is independent of the preparation checking process
 The second check will be documented in electronic ordering
system
 In the absence of a second pharmacist, a chemo-certified RN or
oncology specialty provider may serve as the second check
Pharmacy verifies orders for:
 Presence of signed consent in patient’s medical record
 Two patient identifiers
 Drug name, dose (including calculations), and volume
▪ Significant variances, greater than or equal to 10% in dose, are
clarified with the provider
▪ If the physician wishes to proceed with ordered dose on day one:
 Clarification will read “Day one of chemotherapy will be given as written,
subsequent days of treatment to be rewritten by physician”
 Chemotherapy for subsequent days will be rewritten by the physician within
24 hours
 Rate/duration and route of administration
 Lab values
▪ If lab values provided by outside laboratories are being used, the
values must be included in the order or faxed to the pharmacy
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Nursing chemotherapy order review follows
the process outlined in the DUH Nursing
Process Standard: Chemotherapy
Administration Protocol
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Nursing coordinates the initial scheduling of
chemotherapy administration to:
 Avoid wasting drug
 Avoid delays in treatment
 Create an accurate medication
administration record
All questions are resolved with the prescriber by pharmacy or
nursing before implementation of the orders
 Pharmacy and nursing will communicate with each other the need for
resolution and possible delay
 Discussion with the provider should follow SBAR (Situation, Background,
Assessment, Recommendation) communication techniques
 When questions/issues are resolved, clarification will be documented in
the electronic ordering system or on a paper order form
 Pharmacy and nursing will communicate with each other when resolution of
questions/issues has been obtained
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Initiate Pharmacy Referral Process:
1.
2.
3.
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Consult with an oncology pharmacist, if not already done
If unresolved, pharmacy referral is made to the area’s pharmacy
supervisor
If unresolved, pharmacy referral is made to the Department of
Pharmacy administrator on call
If resolution not obtained through Pharmacy Referral Process,
remaining issues will be referred to physician leadership by
pharmacy:
1.
2.
3.
Consult with senior faculty specializing in the same or similar patient
populations
If unresolved, consult with physician leadership within the same
division or Clinical Service Unit (CSU)
If unresolved, consult with senior physician faculty for the hospital
(P&T Chair or Chief Medical Officer)
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Advancing Orders
 To “advance” chemotherapy (start earlier each day), it must
be stated in the original order
Rescheduling Orders
 Any Duke prescriber approved to prescribe medications can
write to proceed with administration, stop administration, or
change the rate of intravenous chemotherapy administration
Moving Orders & Adjusting Dates
 Within 72 hours of original order
▪ May be adjusted by Fellows, NPs, PAs, and Pharmacists
 Greater than 72 hours of original order
▪ Requires verification with provider
▪ May be adjusted by Fellows, NPs, PAs, and Pharmacists
DO NOT discontinue,
change or move
approved CPOE orders
that have already been
dispensed without
notifying pharmacy

If a chemotherapy order is temporarily held, a “resume previous
chemotherapy order” may be written by an authorized
chemotherapy prescriber

If chemotherapy orders are discontinued electronically due to a
patient’s post-op status or transfer (service or location), any
authorized chemotherapy prescriber may write to continue
chemotherapy orders as previously written
 Order will specify number of days of therapy remaining
 Pharmacy will coordinate scheduling and verify accuracy of dates and
times
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If the chemotherapy orders are to be discontinued post-op, upon
transfer of service or location, or for other reasons, an order will be
written by the accepting physician
Dispensing
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Chemotherapy labels must include:
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Patient’s name and a second patient identifier
Generic drug name
Total dose
Administration route
Total volume
Infusion duration
Date of administration
Date and time of preparation and expiration
Turnaround times:
 Inpatient: Two hours after pharmacy review and verification is complete
 Outpatient: One hour after pharmacy review and verification is complete
Pharmacy preparation and despensing
cut off times
 Inpatient
▪ Scheduled admissions: orders need
to be provided to the pharmacy by 1700
▪ Existing inpatients: orders need to be
provided to the pharmacy by 2000
▪ Emergent chemotherapy will be allowed following physician,
pharmacist, and nursing discussion and agreement
▪ If prioritization of chemotherapy preparation and dispensing is required
due to high volume, pharmacist will discuss the ability to defer nonemergent chemotherapy with provider
▪ Pharmacy will discuss with nursing and document
Pharmacy preparation and dispensing
cut off times
 Outpatient
▪ Cancer Center Infusion Pharmacy: orders
be provided to the pharmacy
by 1700
need to
▪ North Pavilion: orders need to be provided to the pharmacy by 1500
▪ Pediatrics: the “Go” must be received by 1600
For any questions regarding the chemotherapy
policy, please contact:
Hope Uronis, MD, MHS
OR
Sally Barbour, PharmD, BCOP, CPP
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