Education For Safe Prescribing And Dispensing Of Chemotherapy

1. February 2013 Education For Safe Prescribing And Dispensing Of Chemotherapy

2. Learning Objectives After 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.

3. 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

4. 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]

5. 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

6. Definition Of CancerChemotherapy 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

7. Definition Of CancerChemotherapy 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

8. Prescribing

9. 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)

10. 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

11. Who Is Authorized To Prescribe Chemotherapy? Only attending physicians in the divisions listed below are authorized to prescribe chemotherapy for non-malignant indications in adults: • Cardiology • Dermatology • Gastroenterology • Medicine • Neurology • Nephrology • Obstetrics/Gynecology • Ophthalmology • Pulmonary and Critical Care • Psychiatry • Rheumatology • Urology

12. Who Is Authorized To Prescribe Chemotherapy - Peds? Only attending physicians in the divisions listed below are authorized to prescribe cancerchemotherapy in pediatrics: • Divisions of Pediatric Hematology-Oncology • Pediatric Neuro-Oncology • Pediatric Blood and Marrow Transplantation

13. Who Is Authorized To Prescribe Chemotherapy - Peds? Only attending physicians in the divisions listed below are authorized to prescribe chemotherapy for non-malignantindications in pediatrics: • Allergy & Immunology • Cardiology • Dermatology • Gastroenterology • Medical Genetics • Neurology • Nephrology • Pulmonary and Critical Care • Rheumatology

14. What About Fellows, PAs, NPs CPPs And Other MDs? • Fellows, Physician Assistants (PAs), Nurse Practitioners (NPs), and Clinical Pharmacist Practitioners (CPPs) are notauthorized 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

15. Patient Education And Consent 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)

16. 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

17. Orders

18. 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

19. 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”

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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 basedon 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

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

33. Questions And Issues With Orders All questions are resolved with the prescriber by pharmacy or nursing beforeimplementation 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

34. For Unresolved Questions/Issues With Orders • Initiate Pharmacy Referral Process: • 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: • 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)

35. 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

36. Scheduling Orders DO NOT discontinue, change or move approved CPOE orders that have already been dispensed without notifying pharmacy

37. 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

38. Dispensing

39. 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

40. 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

41. 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

42. Questions For any questions regarding the chemotherapy policy, please contact: Hope Uronis, MD, MHS OR Sally Barbour, PharmD, BCOP, CPP Proceed to the next slide to begin quiz

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