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Risk Reduction Strategies for High-Alert Medications Richard C. Walls Advisor: Scott Ciarkowski 2013-10-04.

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Presentation on theme: "Risk Reduction Strategies for High-Alert Medications Richard C. Walls Advisor: Scott Ciarkowski 2013-10-04."— Presentation transcript:

1 Risk Reduction Strategies for High-Alert Medications Richard C. Walls Advisor: Scott Ciarkowski

2 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

3 High-Alert Medication: Definition 1 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 reaction 2

4 High-Alert Medication: ISMP Examples 3,4 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

5 High-Alert Medications Joint Commission standard MM 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 requirements 6

6 Developing a High-Alert Medication List ISMPs lists a good starting point 3,4 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 institutions patient population

7 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 Electrolytes 7 DO NOT INCLUDE: Unconcentrated PO Electrolytes 8

8 Developing a High-Alert Medication List List should be dynamic 6 List should be known to all practitioners List should be backed by processes that reduce errors, and which reduce the risk associated with errors

9 Low-Leverage Risk Reduction Strategies Staff Education Programs Labels & Manual Double Checks Bulletins

10 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 term 9, 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

11 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

12 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

13 Medication Use Process: Overview Prescribing -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

14 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 Administration -Administer wrong drug -Administer to wrong patient -Administer at wrong time -Improper technique Monitoring -Failure to monitor -Failure to report monitored information

15 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

16 Role of Pharmacists in Reducing Error Be familiar with your institutions 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

17 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

18 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 patients 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 patients height and weight.

19 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.

20 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.

21 Putting it All Together Developing a comprehensive risk-reduction program for high-alert medications

22 A General Stepwise Approach 1. Build a list of high-alert medications 2. Identify likely causes of medication errors 3. Develop multiple strategies to target possible sources of error 4. Identify process and outcome measures to evaluate strategy effectiveness 5. Implement strategies and collect effectiveness data 6. Regularly review effectiveness data and revise programs in accordance with results

23 A Comprehensive Institutional Program: Insulin Step 1: Build a list of high-alert medications Why insulin 10 ? 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

24 A Comprehensive Institutional Program: Insulin Step 2: Identify likely causes of medication errors 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

25 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

26 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

27 A Comprehensive Institutional Program: Insulin Step 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.

28 A Comprehensive Community Program: Warfarin Step 1: Build a list of high-alert medications Why warfarin 12 ? 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

29 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

30 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

31 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

32 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.

33 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

34 References 1. Institute for Safe Medication Practices [Internet]. High-Alert Medications. Horsham, PA. (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 Sep 1;65(17): Institute for Safe Medication Practices [Internet]. Institutional High-Alert Medication List. Horsham, PA. (accessed 2013).http://www.ismp.org/tools/institutionalhighAlert.asp 4. Institute for Safe Medication Practices [Internet]. Institutional High-Alert Medication List. Horsham, PA. (accessed 2013).http://www.ismp.org/tools/ambulatoryhighAlert.asp 5. The Joint Commission [Internet]. Pre-Publiation Requirements. df (accessed 2013). df 6. Institute for Safe Medication Practices [Internet]. Your High-Alert Medication List: Relatively Useless without Associated Risk-Reduction Strategies. (accessed 2013).

35 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 Nov;50(11): 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 Aug 15;70(16): 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 Sep- Oct;52(5):


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