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Education For Safe Prescribing And Dispensing Of Chemotherapy

February 2013

Learning ObjectivesAfter completing this module, the learner will be able to: Describe the process for “Safe Prescribing

and Dispensing of Chemotherapy” Identify key responsibilities for each member

of the team caring for patients receiving chemotherapy

To view the policies, click the attachment button located in the upper right corner of this slide.

Overview Chemotherapy is a high-risk

medication It is used to treat malignant and

non-malignant disease states

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

Definition Of Chemotherapy At Duke

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]

Remember . . .

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

Definition Of Cancer Chemotherapy At Duke

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

Definition Of Cancer Chemotherapy At Duke

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

Prescribing

Who Is Authorized To Prescribe Chemotherapy?

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)

Who Is Authorized To Prescribe 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

Who Is Authorized To Prescribe Chemotherapy?

Cardiology Dermatology Gastroenterology Medicine Neurology Nephrology Obstetrics/

Gynecology

Ophthalmology Pulmonary and

Critical Care Psychiatry Rheumatology Urology

Only attending physicians in the divisions listed below are authorized to prescribe chemotherapy for non-malignant indications in adults:

Who Is Authorized To Prescribe Chemotherapy - Peds?

Only attending physicians in the divisions listed below are authorized to prescribe cancer chemotherapy in pediatrics: Divisions of Pediatric

Hematology-Oncology Pediatric Neuro-Oncology Pediatric Blood and Marrow

Transplantation

Who Is Authorized To Prescribe Chemotherapy - Peds?

Allergy & Immunology

Cardiology Dermatology Gastroenterology Medical Genetics Neurology Nephrology

Pulmonary and Critical Care

Rheumatology

Only attending physicians in the divisions listed below are authorized to prescribe chemotherapy for non-malignant indications in pediatrics:

What About Fellows, PAs, NPs CPPs And Other MDs?

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

Patient Education And ConsentAll 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)

What About Non-malignant Indications At Duke? 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

How To Order Cancer Chemotherapy

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 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 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”

Guidelines For Ordering Chemotherapy 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

Guidelines For Ordering Chemotherapy 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

Required Elements Of A Chemotherapy Order 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

Required Elements Of A Chemotherapy Order 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

Required Elements Of A Chemotherapy Order

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

Required Elements Of A Chemotherapy Order

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

Required Elements Of A Chemotherapy Order 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

Rounding Of Chemotherapy

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

Signature And Approval-Adults

All orders are reviewed and signed/approved by an authorized prescriber

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

Signature And Approval-Pediatrics

All orders are reviewed and signed/approved by an authorized prescriber 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

Pharmacy Chemotherapy Order Review And Preparation

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 Chemotherapy Order Review And Preparation

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

Nursing Chemotherapy Order Review

Nursing chemotherapy order review follows the process outlined in the DUH Nursing Process Standard: Chemotherapy Administration Protocol

Nursing coordinates the initial scheduling of chemotherapy administration to: Avoid wasting drug Avoid delays in treatment Create an accurate medication

administration record

Questions And Issues With Orders

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

For Unresolved Questions/Issues With Orders

Initiate Pharmacy Referral Process:1. Consult with an oncology pharmacist, if not already done2. If unresolved, pharmacy referral is made to the area’s pharmacy

supervisor3. 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. Consult with senior faculty specializing in the same or similar patient

populations2. If unresolved, consult with physician leadership within the same division

or Clinical Service Unit (CSU)3. If unresolved, consult with senior physician faculty for the hospital (P&T

Chair or Chief Medical Officer)

Scheduling Orders 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

Scheduling Orders DO NOT

discontinue, change or move approved CPOE orders that have already been dispensed without notifying pharmacy

Scheduling Orders: Additional Inpatient Considerations 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

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

Dispensing Chemotherapy

Chemotherapy labels must include: 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

Dispensing Chemotherapy

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 non-emergent chemotherapy with provider ▪ Pharmacy will discuss with nursing and document

Dispensing Chemotherapy

Pharmacy preparation and dispensing cut off times Outpatient▪ Cancer Center Infusion Pharmacy: orders

need to be provided to the pharmacy by 1700

▪ North Pavilion: orders need to be provided to the pharmacy by 1500

▪ Pediatrics: the “Go” must be received by 1600

QuestionsFor any questions regarding the

chemotherapy policy, please contact:

Hope Uronis, MD, MHS

OR

Sally Barbour, PharmD, BCOP, CPP

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Chemo_Policy_1_11_13

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