Risk Reduction Strategies for High-Alert MedicationsRichard C. WallsAdvisor: Scott Ciarkowski2013-10-04

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• Anticoagulants• Opioids• Concentrated electrolytes• Antineoplastic agents• Antiretroviral agents• Anesthetic agents• Antiarrhythmic agents• Epidural/intrathecal formulations• Adrenergic agonists• Adrenergic antagonists

• Parenteral nutrition• Dialysis solution• Liposomal formulations• Immunosuppressants• Pregnancy category X drugs• Pediatric liquid formulations• Oral hypoglycemic agents• IV radiocontrast agents• Hypertonic saline• 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 medicationsINCLUDE: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

• IntermittentMay influence behaviors in short term9, with returns dissipating over time

• Focus on IndividualsUtility 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

• ContinuousLess subject to waxing and waning effectiveness

• Focus on SystemsIndefatigable, high yield, pulls blame from individuals

• More effective, but demand more resources• Select strategies relevant to likely errors

Medication Use Process: OverviewPrescribing

-Selection of agent-Selection of dose

Transcribing-Recording prescription in writing-Transferring records between systems

Dispensing/Storage-Preparation of product-Delivery to storage

Administration-Retrieval of product-Administration to patient

Monitoring-Signs of efficacy-Signs of adverse reactions-Reporting of results

Medication Use Process: Possible ErrorsPrescribing

-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

Administration-Administer wrong drug-Administer to wrong patient-Administer at wrong time-Improper technique

Monitoring-Failure to monitor-Failure to report monitored information

Medication Use Process: Possible Appropriate Risk-Reduction Strategies

Prescribing-Standardized dosing-CPOE Order Sets

Transcribing-Integrated CPOE-dispensing-administraton systems

Dispensing/Storage-Automated dispensing-Barcode verification-Separation of look-alike sound-alike medications

Administration-BCMA-Standardized administration protocols-Smart pumps

Monitoring-Standardized monitoring protocols-Electronic lab result notifications

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.

• 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 TogetherDeveloping a comprehensive risk-reduction program for high-alert medications

A General Stepwise Approach1. Build a list of high-alert medications2. Identify likely causes of medication errors3. Develop multiple strategies to target possible

sources of error4. Identify process and outcome measures to

evaluate strategy effectiveness5. Implement strategies and collect effectiveness

data6. Regularly review effectiveness data and revise

programs in accordance with results

A Comprehensive Institutional Program: InsulinStep 1: Build a list of high-alert medications

• Why insulin10?• Significant risk of hypoglycemiaunconsciousness, 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: InsulinStep 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: InsulinStep 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: InsulinStep 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: InsulinStep 4: Identify process and outcome measures to evaluate effectiveness of strategies• Process Measures• Record timing of doses• Record timing of meals• Record timing of glucose

tests• Outcome Measures• Rates of hyperglycemia• Rates of hypoglycemia

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: WarfarinStep 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: WarfarinStep 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: WarfarinStep 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: WarfarinStep 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: WarfarinStep 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

References1. 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.pdf (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).

References7. 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 Sep-Oct;52(5):584-602