Transcript Preventing Medication Errors in Cancer Chemotherapy

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
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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/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.
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/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
Reasons for Increased Risk
• Nonstandard nomenclature
– Use of abbreviations
• AC = (A)driamycin and (C)yclophosphamide
• CHOP =
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(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
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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:
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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:
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Prescribing
Dispensing
Administration/Disposal
Monitoring
Outline of
Error-Prevention Measures
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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
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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
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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, 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
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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/m2 IV daily for 4 days
Standardizing
• Use caution with decimal point placement
Wrong
.1 mg
1.0 mg
Right
0.1 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)
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
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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)
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
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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
vinBLAStine
vinCRIStine
– 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 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)
Improved Labeling
Name warnings
Dose warnings
Label with total vial amount
and
concentration per mL
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 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
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
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
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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:
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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
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 3rd- to 6th-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
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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.