Risk Reduction Strategies for High-Alert Medications

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

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: 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

4. 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

5. 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

6. 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

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 Electrolytes7 DO NOT INCLUDE:Unconcentrated PO Electrolytes8

8. 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

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 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

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 Monitoring -Signs of efficacy -Signs of adverse reactions -Reporting of results Transcribing -Recording prescription in writing -Transferring records between systems Dispensing/Storage -Preparation of product -Delivery to storage Administration -Retrieval of product -Administration to patient

14. Medication Use Process: Possible Errors Prescribing -Irrational dose -Drug-indication mismatch Monitoring -Failure to monitor -Failure to report monitored information Transcribing -Record incorrect dose -Record incorrect agent -Transcription illegible Administration -Administer wrong drug -Administer to wrong patient -Administer at wrong time -Improper technique Dispensing/Storage -Dispense wrong dose -Dispense wrong product -Confusable medications stored in proximity

15. Medication Use Process: Possible Appropriate Risk-Reduction Strategies Prescribing -Standardized dosing -CPOE Order Sets Monitoring -Standardized monitoring protocols -Electronic lab result notifications Transcribing -Integrated CPOE-dispensing-administraton systems Administration -BCMA -Standardized administration protocols -Smart pumps Dispensing/Storage -Automated dispensing -Barcode verification -Separation of look-alike sound-alike medications

16. 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

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 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.

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 • 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

23. 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

24. 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

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 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

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 • Institute for Safe Medication Practices [Internet]. High-Alert Medications. Horsham, PA. http://www.ismp.org/tools/highalertmedicationLists.asp (accessed 2013). • SakowskiJ, 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. • Institute for Safe Medication Practices [Internet]. Institutional High-Alert Medication List. Horsham, PA. http://www.ismp.org/tools/institutionalhighAlert.asp(accessed 2013). • Institute for Safe Medication Practices [Internet]. Institutional High-Alert Medication List. Horsham, PA. http://www.ismp.org/tools/ambulatoryhighAlert.asp(accessed 2013). • The Joint Commission [Internet]. Pre-PubliationRequirements. http://www.jointcommission.org/assets/1/18/LTC_Core_PrepublicationReport_20130102.pdf(accessed 2013). • 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).

35. References • Potassium chloride. In: Micromedex DRUGDEX [Internet Database]. Truven Health Analytics. Updated 2013, September. • Calcium carbonate. In: Micromdex DRUGDEX [Internet Database]. Truven Health Analytics. Updated 2013, October. • 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. • Insulin. In: Micromedex DRUGDEX [Internet Database]. Truven Health Analytics. Updated 2013, August. • 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. • Warfarin. In: Micromedex DRUGDEX [Internet Database]. Truven Health Analytics. Updated 2013, September. • 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