Risk Reduction Strategies for High

Report
Risk Reduction Strategies
for High-Alert Medications
Richard C. Walls
Advisor: Scott Ciarkowski
2013-10-04
Learning Objectives
• Describe characteristics of high-alert medications
• Describe characteristics of effective risk-reduction
strategies for high-alert medications
• Review the medication use process and identify possible
sites for error
• Outline the steps to developing a comprehensive risk-
reduction program
• Present and discuss examples of the implementation of
risk-reduction programs
High-Alert Medication: Definition1
• A high-alert medication is a medication that:
has a high risk of causing patient harm when used in
error.
• A high-alert medication is not necessarily a medication
that has a higher risk of being used in error.
• Sakowski et. Al. evaluated perceived severity of medication
errors saw high-alert medications as 5% more likely to
have a moderate or severe adverse reaction2
High-Alert Medication: ISMP Examples3,4
• Insulin
• Parenteral nutrition
• Anticoagulants
• Dialysis solution
• Opioids
• Liposomal formulations
• Concentrated electrolytes
• Immunosuppressants
• Antineoplastic agents
• Pregnancy category X drugs
• Antiretroviral agents
• Pediatric liquid formulations
• Anesthetic agents
• Oral hypoglycemic agents
• Antiarrhythmic agents
• IV radiocontrast agents
• Epidural/intrathecal
• Hypertonic saline
formulations
• Adrenergic agonists
• Adrenergic antagonists
• Neurommuscular Blocking
Agents
High-Alert Medications
• Joint Commission standard MM.01.01.035
• Institutions must:
• Have a list of high-alert medications
• Develop a process for mitigating risk with high-alert medications
• Implement their process for managing high-alert medications
• Any list and any process meet minimum requirements6
Developing a High-Alert Medication List
• ISMP’s lists a good starting point3,4
• Add or subtract drugs based on institutional needs
• Drugs new to formulary
• Appropriate criteria for therapy not established
• Staff less familiar with processes to manage adverse effects.
• Drugs locally identified to have caused patient harm
• Drugs of particular risk to an institution’s patient population
Developing a High-Alert Medication List
• Inclusion/Exclusion Balance
• Do not want to leave out dangerous medications
• Do not want to expend undue resources monitoring generally safe
medications
INCLUDE:
Concentrated IV Electrolytes7
DO NOT INCLUDE:
Unconcentrated PO Electrolytes8
Developing a High-Alert Medication List
• List should be dynamic6
• List should be known to all practitioners
• List should be backed by processes that reduce errors, and
which reduce the risk associated with errors
Low-Leverage Risk Reduction Strategies
• Staff Education Programs
• Labels & Manual Double Checks
• Bulletins
Low-Leverage Risk Reduction Strategies
• Passive
Inform agents that may prevent medication errors, but do not prevent
errors themselves
• Intermittent
May influence behaviors in short term9, with returns dissipating over
time
• Focus on Individuals
Utility limited by fatigue, time constraints, may create sense of punitive
culture
• Do improve awareness, but must be combined with a more
comprehensive program to maximize effectiveness
High-Leverage Risk Reduction Strategies
• Limit Access
• Separate/locked containers
• Only certain meds in floor stock
• Active Sources of Information
• Electronic notifications (labs, cultures, etc.)
• Deploy clinical pharmacists
• Utilize smart pumps with drug libraries
• Utilize Fail Safes
• Electronic ‘hard stops’
• Oral syringes that cannot be connected to IV ports
High-Leverage Risk Reduction Strategies
• Active
Strategies themselves play a role in making errors less likely
• Continuous
Less subject to waxing and waning effectiveness
• Focus on Systems
Indefatigable, high yield, pulls blame from individuals
• More effective, but demand more resources
• Select strategies relevant to likely errors
Medication Use Process: Overview
Prescribing
-Selection of agent
-Selection of dose
Transcribing
-Recording prescription in
writing
-Transferring records
between systems
Monitoring
-Signs of efficacy
-Signs of adverse reactions
-Reporting of results
Dispensing/Storage
-Preparation of product
-Delivery to storage
Administration
-Retrieval of product
-Administration to patient
Medication Use Process: Possible Errors
Prescribing
-Irrational dose
-Drug-indication mismatch
Transcribing
-Record incorrect dose
-Record incorrect agent
-Transcription illegible
Dispensing/Storage
-Dispense wrong dose
-Dispense wrong product
-Confusable medications
stored in proximity
Monitoring
-Failure to monitor
-Failure to report
monitored information
Administration
-Administer wrong drug
-Administer to wrong
patient
-Administer at wrong time
-Improper technique
Medication Use Process: Possible
Appropriate Risk-Reduction Strategies
Prescribing
-Standardized dosing
-CPOE Order Sets
Transcribing
-Integrated CPOEdispensing-administraton
systems
Dispensing/Storage
-Automated dispensing
-Barcode verification
-Separation of look-alike
sound-alike medications
Monitoring
-Standardized monitoring
protocols
-Electronic lab result
notifications
Administration
-BCMA
-Standardized
administration protocols
-Smart pumps
Role of Pharmacists in Reducing Error
• Be familiar with your institution’s high-alert medication list
• Take more care when verifying high-alert medications
• Recruit double checks on high-alert medications
• Alert downstream personnel of risk
• Report errors identified
• Encourage implementation of error reduction systems
Other Considerations for Error Reduction
• Want to utilize multiple risk-reduction strategies that
target multiple pathways
• Reducing medication errors is a multidisciplinary
responsibility
• Reporting errors is critical for identifying areas for
improvement
Examples of Medication Errors
• Error: Patient prescribed IV acyclovir for possible
meningitis and dosed on actual body weight rather than
adjusted body weight resulted in dose 20% higher than
recommended.
• Possible negative impact of error: Expose patient to
higher risk of adverse effects.
• Possible strategy to reduce error: CPOE that
automatically calculates dose based on patient’s height
and weight.
Examples of Medication Errors
• Error: Patient prescribed Medrol dose pack. Prescriber
labeled “use as directed on package”. Dispensed with label
“take two today, and then one daily until gone”.
• How error was detected: Detected during data entry
double-check.
• How error was mitigated: Called the patient and told her
to follow the instructions in the package, not the label we
affixed to the product.
Examples of Medication Errors
• Error: Multiple instances of wrong drug product being
selected for fill at a community pharmacy.
• How error was detected: Barcode NDC verification
comparing bottle to product specified at data entry.
• How error was mitigated: Put the wrong bottle back on
the shelf and selected the correct one.
Putting it All Together
Developing a comprehensive risk-reduction program for
high-alert medications
A General Stepwise Approach
1.
2.
3.
4.
5.
6.
Build a list of high-alert medications
Identify likely causes of medication errors
Develop multiple strategies to target possible sources of
error
Identify process and outcome measures to evaluate
strategy effectiveness
Implement strategies and collect effectiveness data
Regularly review effectiveness data and revise programs
in accordance with results
A Comprehensive Institutional Program:
Insulin
Step 1: Build a list of high-alert medications
• Why insulin10?
• Significant risk of hypoglycemiaunconsciousness, possibly coma
• Remember that the risk of patient harm is the primary
factor in determining what medications are included in a
high-alert medication list
A Comprehensive Institutional Program:
Insulin
Step 2: Identify likely causes of medication errors11
• Prescribing
• Irrational Dosages
• Transcribing
• Mistranscription
• Dispensing/Storage
• U-100 vs. U-500
• Confusion with heparin
• Administration
• Not associating dose w/meals
• Administering wrong dose
• Monitoring
• Inadequate monitoring
• Failure to adjust dose
A Comprehensive Institutional Program:
Insulin
Step 3: Develop multiple strategies to target possible
sources of error.11
• Prescribing
• Irrational Dosages
• Transcribing
• Mistranscription
• Dispensing/Storage
• U-100 vs. U-500
• Confusion with heparin
• Administration
• Not associating dose w/meals
• Administering wrong dose
• Monitoring
• Inadequate monitoring
• Failure to adjust dose
A Comprehensive Institutional Program:
Insulin
Step 3: Develop multiple strategies to target possible
sources of error.11
• Prescribing
• Standardized order sets
• Transcribing
• CPOE
• Dispensing/Storage
• Store only U-100 on floors
• Segregate look-alike products
• Administration
• Coordinate direct linkage
between blood glucose
monitoring, nutrition, and insulin
administration
• Double-check syringe doses
• Monitoring
• Link testing to administration
• Include dose adjustments in
order set protocols
A Comprehensive Institutional Program:
Insulin
Step 4: Identify process and outcome measures to evaluate
effectiveness of strategies
• Process Measures
• Outcome Measures
• Record timing of doses
• Rates of hyperglycemia
• Record timing of meals
• Rates of hypoglycemia
• Record timing of glucose tests
Step 5: Implement strategies and collect effectiveness data.
Step 6: Regularly review effectiveness data and revise
program in accordance with results.
A Comprehensive Community Program:
Warfarin
Step 1: Build a list of high-alert medications
• Why warfarin12?
• Narrow therapeutic index
• Significant risks associated with both supratherapeutic (bleeding)
and subtherapeutic (DVT, PE, stroke) dosages
• Remember that the risk of patient harm is the primary
factor in determining what medications are included in a
high-alert medication list
A Comprehensive Community Program:
Warfarin
Step 2: Identify likely causes of medication errors
• Wrong dose prescribed
• Wrong dose at data entry
• Prescription entered in wrong patient profile
• Wrong drug strength selected
• Prescription labeled with wrong direction
• Filled prescription placed in wrong bag
A Comprehensive Community Program:
Warfarin
Step 3: Develop multiple strategies to target possible
sources of error.13
• Wrong dose prescribed
• Wrong dose at data entry
• Prescription entered in wrong patient profile
• Wrong drug strength selected
• Prescription labeled with wrong direction
• Filled prescription placed in wrong bag
A Comprehensive Community Program:
Warfarin
Step 3: Develop multiple strategies to target possible
sources of error.13
• Increase patient counseling
• Data verification double checks
• Barcode NDC verification
• Increased automation of filling
• Hard stop alert when irrational warfarin doses are entered
• Show pill image at prescription verification
• Open bag at point-of-sale
A Comprehensive Community Program:
Warfarin
Step 4: Identify process and outcome measures to evaluate
effectiveness of strategies
• Process Measures
• Frequency of counseling
• Percentage of automated fills
• Outcome Measures
• Number of products dispensed
in error
Step 5: Implement strategies and collect effectiveness data.
Step 6: Regularly review effectiveness data and revise
program in accordance with results.
Summary
• High-alert medications have increased risk of causing
patient harm when used in error
• Combining multiple low and high-leverage risk-reduction
strategies are essential to improving outcomes
• Risk-reduction strategies need to be selected based on
errors likely to occur with a particular drug
• Monitoring programs for effectiveness is essential to
guaranteeing sustained success
References
1.
Institute for Safe Medication Practices [Internet]. High-Alert Medications. Horsham, PA.
http://www.ismp.org/tools/highalertmedicationLists.asp (accessed 2013).
2.
Sakowski J, Newman JM, Dozier K. Severity of medication administration errors detected
by a bar-code medication administration system. Am J Health Syst Pharm. 2008 Sep
1;65(17):1661-56.
3.
Institute for Safe Medication Practices [Internet]. Institutional High-Alert Medication List.
Horsham, PA. http://www.ismp.org/tools/institutionalhighAlert.asp (accessed 2013).
4.
Institute for Safe Medication Practices [Internet]. Institutional High-Alert Medication List.
Horsham, PA. http://www.ismp.org/tools/ambulatoryhighAlert.asp (accessed 2013).
5.
The Joint Commission [Internet]. Pre-Publiation Requirements.
http://www.jointcommission.org/assets/1/18/LTC_Core_PrepublicationReport_20130102.p
df (accessed 2013).
6.
Institute for Safe Medication Practices [Internet]. Your High-Alert Medication List:
Relatively Useless without Associated Risk-Reduction Strategies.
http://www.ismp.org/Newsletters/acutecare/showarticle.asp?id=45 (accessed 2013).
References
7.
Potassium chloride. In: Micromedex DRUGDEX [Internet Database]. Truven Health
Analytics. Updated 2013, September.
8.
Calcium carbonate. In: Micromdex DRUGDEX [Internet Database]. Truven Health Analytics.
Updated 2013, October.
9.
Abbasinazari M, Zareh-Toranposhti S, Hassani A, et al. The effect of information provision
on reduction of errors in intravenous drug preparation and administration by nurses in
ICU and surgical wards. Acta Med Iran. 2012 Nov;50(11):771-7.
10.
Insulin. In: Micromedex DRUGDEX [Internet Database]. Truven Health Analytics. Updated
2013, August.
11.
Cobaugh DJ, Maynard G, Cooper L, et al. Enhancing insulin-use safety in hospitals:
Practical recommendations from an ASHP Foundation expert consensus panel. Am J
Health Syst Pharm. 2013 Aug 15;70(16):1404-13.
12.
Warfarin. In: Micromedex DRUGDEX [Internet Database]. Truven Health Analytics. Updated
2013, September.
13.
Cohen MR, Smetzer JL, Westphal JE, et al. Risk models to improve safety of dispensing
high-alert medications in community pharmacies. J Am Pharm Assoc. 2012 SepOct;52(5):584-602

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