Preventing Medication Errors in Cancer Chemotherapy

1. Preventing Medication Errors in Cancer Chemotherapy

2. Learning Objectives Recall errors associated with antineoplastic agents Discuss the magnitude of errors involving cancer chemotherapy Explain common causes of chemotherapy-related errors Describe error reduction strategies Describe the role of the multidisciplinary team in error prevention

3. Adverse Drug Events ADEs are injuries that result from drug use May be preventable or nonpreventable Potential ADEs result from medication errors with potential for harm but: Are intercepted before reaching patient, or Reach patient but do not cause harm .

4. Chemotherapy • Medications used alone or in combination to target cancer cells in the body • Goals of chemotherapy • Increase quality of life • Decrease tumor burden • Provide remission period • Provide a cure • Medications may be administered in any form: oral, IV, IM, subcutaneous, intrathecal, etc.

5. Chemotherapy • Chemotherapy is a biohazard to those preparing and administering the agents • May cause adverse effects to any individual who comes in contact with the agents • Special protocols required for preparation, administration, and disposal of chemotherapy • Medication errors may cause harm to patients or practitioners

6. Sample Chemotherapy Protocol Placeholder for faculty to insert sample of a chemotherapy protocol used at a local institution Use this protocol to demonstrate the complexity of the order form and the potential for the form to cause errors

7. Magnitude of Problem Medication error rate: estimated that 500 deaths occur annually in the United States from chemotherapy medication errors Approximately 3% of errors involving chemotherapy are reported 63% of oncology nurses reported occurrence of chemotherapy errors in their place of work Northfelt DW, et al. Proc Am Soc Clin Oncol. 2003;22:542. Abstract 2181. Schulmeister L. Oncol Nurs Forum. 1999;23:1033–42.

8. Error Bringing National Attention Betsy Lehman (Boston Globe reporter) Breast cancer patient Ambiguous order: “4 g/m2 over four days” Intended dose of cyclophosphamide 1 g/m2 daily for 4 days Dose of cyclophosphamide administered 4 g/m2 daily for 4 days! Result: fatal cardiac toxicity Knox RA. Boston Globe. June 26, 1995.

9. Reasons for Increased Risk Complex chemotherapeutic regimens Multiple medications make up each regimen Adriamycin plus cyclophosphamide, followed by taxol Chemotherapeutic agents combined with supportive therapies Antiemetics, colony-stimulating factors, etc. Each regimen may require three to four “pre-medications” for prevention of nausea or other adverse effects Some pre-medications may be administered by the patient at home

10. Reasons for Increased Risk Complex dosing calculations Dosing using body surface area (BSA) 1 g/m2 daily Multiple-day regimens 1 g/m2 daily given on days 1,3,5 1 g/m2 daily given every 2 weeks for four cycles Administration variability Same drug administered IV push, intermittent IV infusion, multiple-day continuous infusion Oral administration of IV or subcutaneous products

11. Reasons for Increased Risk Nonstandard nomenclature Use of abbreviations AC = (A)driamycin and (C)yclophosphamide CHOP = (C)yclophosphamide Adriamycin (H)ydroxydoxorubicin Vincristine (O)ncovin (P)rednisone Nonstandard or investigational protocols Dosing protocols may not be available in published textbooks for verification

12. Outline of Error-Prevention Measures Educating Health Care Providers Verifying the Dosage Establishing Dosing Limits Standardizing Working With Pharmaceutical Manufacturers (Problems With Labeling) Educating Patients Improving Communication

13. Educating Health Care Providers Intensive education specific to each provider’s core function should be mandatory Prescribing, dispensing, preparing, administration, monitoring Include examples of serious medication errors in competency training If chemotherapy is allowed to be dispensed and administered on all shifts, then all providers, regardless of which shift they typically work, should be trained

14. Educating Health Care Providers Recommended training schedule Upon initial hire Annually, as supported by The Joint Commission competency standards When a new drug is added to the formulary When an investigational protocol is initiated

15. Educating Health Care Providers • Incorporate various methods of education • Live lectures • Video simulations of compounding • Written programs • Newsletters • Witnessed simulations

16. Reference Materials Must be readily available where needed Must be kept up to date Reference materials should include: Appropriate uses of medications Precautions Adverse effects Dose-limiting and infusion-limiting effects Solution preparation and infusion methods Usual adult and pediatric doses Doses for single and multiple courses of therapy

17. Reference Materials Institution-specific materials should include: Investigational protocols Process to keep references current Outdated material must be removed Site-specific policies and procedures for: Prescribing Dispensing Administration/Disposal Monitoring

18. Outline of Error-Prevention Measures • Educating Health Care Providers • Verifying the Dosage • Establishing Dosing Limits • Standardizing • Working With Pharmaceutical Manufacturers (Problems With Labeling) • Educating Patients • Improving Communication

19. Dosage Verification Process Include several independent double checks Two individuals checking the steps without bias from each other Policy should define: When and by whom double checks will be done How double checks will be documented

20. Dosage Verification Process • Examples of when double checks might be performed: • After drug is ordered • Checked by second authorized prescriber • Checked by a pharmacist referring to treatment protocol and patient-specific data (e.g., current weight, serum creatinine, liver enzyme levels) • If treatment protocol is unavailable, check literature support for regimen or obtain documented support for regimen from prescriber • Calculations used for dose • Checked by two pharmacists • After medication is prepared • Final product checked by second pharmacist referring to original order and drug vials used during preparation • Just prior to administration • Label on dose checked by two nurses against original order

21. Dosage Verification Process Focus on: Calculations Base on correct dose Individual dose Daily dose Weekly dose “Course” dose “Cycle” dose Base on correct body size measure Body surface area Total body weight Ideal body weight

22. Dosage Verification Process Focus on: Protocol parameters Have the correct lab values been checked? Has the patient been properly hydrated? Are the correct antineoplastic drugs ordered? Have ancillary drugs been ordered? Have drugs been ordered with the correct doses and frequencies?

23. Dosage Verification Process Other specific issues to address Where will the double checks be? Who will do the double checking? How will double checking be documented? Which staff may administer chemo? Which nursing units are equipped with staff and supplies necessary for administration? Will administration be allowed only on day shift or within specified staffing ratios?

24. Outline of Error-Prevention Measures • Educating Health Care Providers • Verifying the Dosage • Establishing Dosing Limits • Standardizing • Working With Pharmaceutical Manufacturers (Problems With Labeling) • Educating Patients • Improving Communication

25. Establishing Dosing Limits Define upper and lower dosing limits Utilize published literature Involve multidisciplinary sources An upper limit for one regimen may not equal an upper limit for another regimen Include these limits in computerized order entry programs or dosing software

26. Establishing Dosing Limits Include dosing limits in preprinted order forms or protocols Establish limits for infusion rate and duration For situations in which prescribers want doses that exceed published guidelines: Define review process to address doses that fall outside predetermined limits

27. Methotrexate and Lomustine High risk of errors due to multiple dosing schedule possibilities Both agents often self-administered at home Methotrexate may be utilized orally for non-cancer indications Typically dosed weekly Lomustine should only be administered every 6 weeks

28. Methotrexate and Lomustine Build alerts into electronic prescribing and pharmacy computer systems Ask the indication for use Provide clear written patient instructions in addition to label instructions Lomustine Include the words “SINGLE DOSE ONLY” on the label or medication administration record Dispense quantity for only one dose Counsel, counsel, counsel

29. Inadvertent Intrathecal Administration • Multiple reports of inadvertent intrathecal administration of vincristine • Often administered in regimens that include other drugs administered via intrathecal route • Often administered in unit-dose syringe because of small dose • Easily mistaken for an intrathecal dose

30. Inadvertent Intrathecal Administration • Prevention: • Restrict route of vincristine administration to IV only • Enlist additional warning labels and special packaging • Prepare vincristine for IV administration in a small-volume IV bag instead of a syringe • Use a forcing function in which intrathecal medication is not dispensed until empty vincristine bag returned to pharmacy • Dispense intrathecal medication just prior to use • Never deliver IV and intrathecal medications together • Establish list of drugs for intrathecal administration; ban all other drugs from lumbar puncture procedure rooms • Have at least two practitioners independently verify and document all intrathecal doses before administration • Adopt syringes for intrathecal or epidural use that are not interchangeable with syringes for IV use • Have accrediting and regulatory bodies provide oversight

31. Outline of Error-Prevention Measures • Educating Health Care Providers • Verifying the Dosage • Establishing Dosing Limits • Standardizing • Working With Pharmaceutical Manufacturers (Problems With Labeling) • Educating Patients • Improving Communication

32. Standardizing • Require orders to be written using only approved generic names • Do not allow abbreviations of drug names or protocols to be used • Doses should specify daily drug dose, followed by number of days to be administered • 1 g/m2 IV daily for 4 days

33. Standardizing • Use caution with decimal point placement WrongRight .1 mg 0.1 mg 1.0 mg 1 mg • Standardize method for calculating body surface area (BSA) • Include dose according to BSA and calculated dose in the order • 1 g/m2 IV daily (1.63 g)

34. Standardizing Develop multidisciplinary procedures Procedures should be site specific Determine prescriptive authority Attendings or oncology specialists only Do residents have authority to prescribe chemo? Use standardized order sheets Decreases potential for handwriting errors Careful attention should be paid to format of order sheets Integrate precautions for look-alike, sound-alike therapies

35. Standardizing Date (D/M/Y) and time all orders Record patient’s weight and BSA on order No verbal orders Use only generic names for drugs No abbreviations for drugs or protocols Prescribe using metric weight or units Use decimals appropriately Express dose in dosage unit/m2 or dosage unit/kg (i.e., mg/m2 or mg/kg)

36. Standardizing • Express daily dose times the number of days—nottotal course dose • Specify route and duration of infusion • Do not allow re-orders or resume orders • Perpetuates error from one cycle to another • A patient’s weight may change between cycles

37. Outline of Error-Prevention Measures • Educating Health Care Providers • Verifying the Dosage • Establishing Dosing Limits • Standardizing • Working With Pharmaceutical Manufacturers (Problems With Labeling) • Educating Patients • Improving Communication

38. Working With Pharmaceutical Manufacturers Problems with labeling – Look-alike, sound-alike (LASA) vials or packaging – Confusing package insert wording – Labeling ambiguity – Confusing reconstitution instructions

39. Look-Alike, Sound-Alike Drug Names Cisplatin Cytoxan Dactinomycin Xeloda Neupogen Isotretinoin Taxotere Mitoxantrone Folic acid Carboplatin Cytosar Daptomycin Xenical Neumega Tretinoin Taxol Mitomycin Folinic acid

40. Look-Alike, Sound-AlikeDrug Names Prevention strategies Use of TALL-man lettering • Examples: vinblastine vinBLAStine vincristine vinCRIStine Physically separate look-alike, sound-alike drugs when storing Use generic names when discussing antineoplastic agents

41. Additional Information on Look-Alike and Sound-Alike Medications and Packaging Available in Slide Deck for Chapters 6 and 7

42. Confusing Package Insert Labeling Confusing cyclophosphamide package insert Cardiotoxicity observed with doses of 120–270 mg/kg administered over a few days 120–270 mg each day for several days? 120–270 mg in divided doses over several days? Is 120–270 mg the recommended dose?

43. Labeling Ambiguity Medication vials with volumes greater than 1 mL labeled with concentration only in mg/mL Examples: Camptosar (irinotecan) labeled 20 mg/mL (in 5 mL vial) Entire contents of the vial (100 mg) mistaken as 20 mg Vinorelbine labeled 10 mg/mL (in 5 mL vial) Entire contents of the vial (50 mg) mistaken as 10 mg Fix: Label all vials with both: Total amount of drug per total volume (e.g., 50 mg/5 mL) Amount of drug per mL (e.g., 10 mg/mL)

44. Improved Labeling Dose warnings Name warnings Label with total vial amount and concentration per mL Note: These improved labeling strategies should also be used on the vial itself.

45. Confusing Reconstitution Instructions Labeled concentrations: unclear if they refer to concentration before or after reconstitution Taxotere (docetaxel) 20 mg Packaged with two vials: concentrated drug vial + diluent vial Concentrated drug vial labeled as “20 mg/0.5 mL” Misread as concentration after dilution Mylotarg (gemtuzumab ozogamicin) Labeled as “each 20 mL vial contains 5 mg of Mylotarg” Misread as concentration after dilution

46. Confusing Reconstitution Instructions Medication packaged with incorrect volume of diluent Neumega (oprelvekin) Only 1 mL of diluent should be used but packaged with 5 mL of diluent

47. You Can Made a Difference Be on the lookout for confusing or ambiguous labeling Report problems 1-800-FAIL-SAFE https://www.ismp.org/orderforms/reporterrortoismp.asp

48. Outline of Error-Prevention Measures Educating Health Care Providers Verifying the Dosage Establishing Dosing Limits Standardizing Working With Pharmaceutical Manufacturers (Problems With Labeling) Educating Patients Improving Communication

49. Educating Patients Counsel patients on chemotherapy agents A medication error may be averted Information for patients: Generic and brand names of all agents Indication Usual and actual doses Expected and possible adverse effects Methods of preventing and treating adverse effects Prescribers should discuss the therapy regimen with patients The pharmacist then serves as a double check with the patient while counseling

50. Educating Patients Include a family member or caregiver in the education process Caregiver is a double check for the patient at home Recommend that patients write down everything Instructions from prescribers Keep track of when “pre-meds” taken, supportive therapies, and chemotherapy It is very easy to lose track of what is being taken and when Record adverse effects and timing of these effects