Preventing Medication Errors in Cancer Chemotherapy Learning Objectives

Preventing Medication Errors in Cancer Chemotherapy

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

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 .

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.

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

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

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.

Error Bringing National Attention • Betsy Lehman (Boston Globe reporter) – Breast cancer patient – Ambiguous order: “ 4 g/m 2 over four days” • Intended dose of cyclophosphamide – 1 g/m 2 daily for 4 days • Dose of cyclophosphamide administered – 4 g/m 2 daily for 4 days! – Result: fatal cardiac toxicity Knox RA. Boston Globe. June 26, 1995.

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 “premedications” for prevention of nausea or other adverse effects – Some pre-medications may be administered by the patient at home

Reasons for Increased Risk • Complex dosing calculations – Dosing using body surface area (BSA) • 1 g/m 2 daily – Multiple-day regimens • 1 g/m 2 daily given on days 1, 3, 5 • 1 g/m 2 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

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

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

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

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

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

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

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

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

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

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

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

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?

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?

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

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

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

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

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

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

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

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

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/m 2 IV daily for 4 days

Standardizing • Use caution with decimal point placement Wrong. 1 mg 1. 0 mg Right 0. 1 mg • Standardize method for calculating body surface area (BSA) • Include dose according to BSA and calculated dose in the order – 1 g/m 2 IV daily (1. 63 g)

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

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/m 2 or dosage unit/kg (i. e. , mg/m 2 or mg/kg)

Standardizing • Express daily dose times the number of days—not total 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

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

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

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

Look-Alike, Sound-Alike Drug Names • Prevention strategies – Use of TALL-man lettering • Examples: vinblastine vincristine vin. BLAStine vin. CRIStine – Physically separate look-alike, sound-alike drugs when storing – Use generic names when discussing antineoplastic agents

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

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?

Labeling Ambiguity • Medication vials with volumes greater than 1 m. L labeled with concentration only in mg/m. L – Examples: • Camptosar (irinotecan) labeled 20 mg/m. L (in 5 m. L vial) – Entire contents of the vial (100 mg) mistaken as 20 mg • Vinorelbine labeled 10 mg/m. L (in 5 m. L 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 m. L) – Amount of drug per m. L (e. g. , 10 mg/m. L)

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

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 m. L” – Misread as concentration after dilution – Mylotarg (gemtuzumab ozogamicin) • Labeled as “each 20 m. L vial contains 5 mg of Mylotarg” – Misread as concentration after dilution

Confusing Reconstitution Instructions • Medication packaged with incorrect volume of diluent – Neumega (oprelvekin) • Only 1 m. L of diluent should be used but packaged with 5 m. L of diluent

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

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

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 therapy regimen with patients – The pharmacist then serves as a double check with the patient while counseling

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

Informed Consent to Participate in Clinical Research • Provide clear information to educate potential trial participants • Institutional review boards should review the entire informed consent process—not just the document • Provide sufficient time to decide about participation • Simplify consent form; use 3 rd- to 6 th-grade reading level • Include information concerning compensation of investigators • Consent process should be dynamic and ongoing • A variety of tools can be used to inform potential participants

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

Improving Communication • Listen carefully to: – Other practitioners – Patients and family members • Multidisciplinary communication improves outcomes • Evaluate any medication error made – Determine root cause – Outline future prevention strategies

Need for Pharmacist Involvement in Chemotherapy • Be involved at any site where antineoplastics are provided – Provide double checks – Participate in multidisciplinary decisions – Provide education to practitioners and patients

References Knox RA. Response is slow to deadly mixups. Too little done to avert cancer drug errors. Boston Globe. June 26, 1995: 29, 33. Northfelt DW, Allbritton DW, Parra LS, et al. Medication errors in cancer therapy: review and proposal for systematic study. Proc Am Soc Clin Oncol. 2003; 22: 542. Abstract 2181. Schulmeister L. Chemotherapy medication errors: descriptions, severity, and contributing factors. Oncol Nurs Forum. 1999; 23: 1033– 42.