1. Reducing Emergency Department Visits due to Adverse Events from Medications Daniel Budnitz MD, MPH, CDR USPHS Division of Healthcare Quality Promotion USPHS Scientific & Training Symposium May 25, 2010

2. Disclaimer “The findings and conclusions in this presentation are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention”

3. 1.An injury-based approach to medication safety –Errors vs. harm 2.Population-based harm data for priority setting – Frequency, severity, preventability 3.Patient-centered interventions – Opportunities, collaboration & injury prevention Overview

4. 1. An Injury-based Approach

5. Bank Robber http://www.fbi.gov/libref/historic/famcases/sutton/sutton.htm 1901 - 1980

6. William Sutton Gentleman, Innovator, &… Bank Robber http://www.fbi.gov/libref/historic/famcases/sutton/sutton.htm 1901 - 1980

7. “Slick Willie” Sutton Gentleman, Innovator, &… Bank Robber “Why do you rob banks?” “Because, that’s where the money is.” http://www.fbi.gov/libref/historic/famcases/sutton/sutton.htm 1901 - 1980

8. Sutton’s Law & Drug Safety “Where the highest costs are incurred, therein lies the highest potential for over-all cost reduction” -- Sutton’s Law applied to management accounting

9. Sutton’s Law & Drug Safety “Where the highest costs are incurred, therein lies the highest potential for over-all cost reduction” -- Sutton’s Law applied to management accounting “Where the highest number of adverse drug events (ADEs) occur, therein lies the highest potential for over-all harm reduction” -- Sutton’s Law applied to drug safety

10. 20002006 Mediation Safety in 2000s: Decade of Errors

11. A Focus on Error Reduction… Errors Errors = Preventable events that may lead to inappropriate medication use or patient harm

12. ... Rather Than Harm Reduction ADEs ADE = Injury (harm) caused by a drug

13. Some Errors ∩ Harm Stable Patient ADEsErrors Injured Patient

14. Why Not Start with Harms? Errors (Harms) ADEs Injured Patient

15. Focus on Harms that are… Errors Injured Patient Serious, Common, Preventable

16. Design Intervention Evaluate Impact Identify Risk & Protective Factors Identify the Harm Population Surveillance Data Drive the Public Health Approach Public Health Approach

17. Design Intervention Evaluate Impact Identify Risk & Protective Factors Identify the Harm Public Health Approach Little national data on harms Population Surveillance Data Drive the Public Health Approach

18. Evaluate Impact Identify the Harm January, 2000 “…the data on emergency department visits and hospital admissions are insufficient for estimating overall ADE frequency”

19. 2. Population-based Harm Data for Priority Setting Frequency, severity, preventability

20. Why Emergency Visits & Hospitalizations? Medication use 1 – 82% adults take at least 1 medicine – 18% adults >64 take 10 or more 1. 1. Slone Epidemiology Center at Boston University, 2008

21. Why Emergency Visits & Hospitalizations? Medication use 1 – 82% adults take at least 1 medicine – 18% adults >64 take 10 or more Medication costs 2 1. 1. Slone Epidemiology Center at Boston University, 2008 2. 2. Hoffman et al. Am J Health Syst Pharm 2009;66:237-57 HospitalsClinicsCommunity $27B$33B$227B

22. Serious, Acute Harms: Emergency Departments (EDs) Community Setting ED visit

23. Stratified probability sample of 24-hour EDs - 63 hospitals - 4 strata by hospital size / 1 stratum for pediatric Cases weighted by inverse probability of selection NEISS-CADES: Population Representative Surveillance

24. Case Definition (ADEs) Injury from the use of a drug: Emergency department (ED) visit Treating physician explicitly attributed To a drug* Intended for therapeutic use *Drugs include: Rx, OTC, Supplements, Vaccines Budnitz DS et al. JAMA 2006;296:1858-1866

25. Estimated Annual Impact of Ambulatory Adverse Drug Events 2004-2005 Deaths Hospitalizations Emergency visits Office visits >700,000 >117,000 > 3.6 million ? 14.3 per 1,000 2.4 per 1,000 0.4 per 1,000 Zhan C et al. Jt Comm J Qual Patient Saf 2005;7:372-8 Budnitz DS et al. JAMA 2006;296:1858-66

26. ED Visits for ADEs by Event Type, United States, 2004-2005 Budnitz, D. S. et al. JAMA 2006;296:1858-1866. Budnitz DS et al. JAMA 2006;296:1858-1866 Similar numbers of ED visit for allergic reactions, non-allergic adverse effects, and unintentional overdoses

27. Budnitz, D. S. et al. JAMA 2006;296:1858-1866. Budnitz DS et al. JAMA 2006;296:1858-1866 Hospitalizations for ADEs by Event Type, United States, 2004-2005 Most hospitalizations due to unintended overdoses  66% due to warfarin, antidiabetic agents, or other narrow-therapeutic index drugs ►

28. Drugs Implicated in ED Visits for ADEs United States, 2004-2005 Budnitz DS et al. JAMA 2006;296:1858-1866 ► ►

29. ADEs Treated in EDs by Patient Age, United States, 2004-2005 Budnitz DS et al. JAMA 2006;296:1858-1866

30. Design Intervention Identify Risk & Protective Factors Identify the Harm Older Adults ~ 1 out of 150 per year ~ 7x hospitalization rate ~ 927,000 ED visits, 2008 Public Health Approach for Medication Safety, 2008

31. Design Intervention Identify Risk & Protective Factors Identify the Harm Older Adults ~ 1 out of 150 per year ~ 7x hospitalization rate ~ 927,000 ED visits, 2008 Public Health Approach for Medication Safety “Potentially Inappropriate” Medications ??

32. Budnitz, DS et al. Ann Intern Med 2007;147:755-765 “Potentially Inappropriate” Medicines Adapted from Fick DM et al. Arch Intern Med 2003;163:2716-25

33. “Potentially Inappropriate” Prescribing Impacts Interventions National Quality Measures – HEDIS / National Quality Forum measure – AHRQ annual Healthcare Quality Report CMS – Monitoring of nursing home prescribing – Part D payment for Medication Therapy Management – 9 th Scope of Work for quality improvement Computerized clinical decision support – “Meaningful Use”

34. Frequency of ED Visits for ADEs, Persons ≥65 Years Budnitz DS et al. Ann Intern Med 2007;147:755-765 ►

35. Frequency of ED Visits for ADEs, Persons ≥65 Years Budnitz DS et al. Ann Intern Med 2007;147:755-765 ► ► ► ►

36. Frequency of ED Visits for ADEs, Persons ≥65 Years Budnitz DS et al. Ann Intern Med 2007;147:755-765

37. Risk of ED Visits for ADEs, Persons ≥65 Years Budnitz DS et al. Ann Intern Med 2007;147:755-765

38. Based on Harm: Focus on Older Adults & Certain Medicines Frequency: – 1 in 150 older adults / year Severity: 7x more likely to be hospitalized Preventability: Dosing and monitoring – 3 drugs (insulin, warfarin, and digoxin) – 33% of estimated ADEs treated in EDs

39. Design Intervention Identify Risk & Protective Factors Identify the Harm Older Adults ~ 1 out of 150 per year ~ 7x hospitalization rate ~ 927,000 ED visits, 2008 Public Health Approach for Medication Safety “Potentially Inappropriate” Medications

40. Design Intervention Identify Risk & Protective Factors Identify the Harm Older Adults ~ 1 out of 150 per year ~ 7x hospitalization rate ~ 927,000 ED visits, 2008 Public Health Approach for Medication Safety Anticoagulants Insulins NTI Medicines

41. Design Intervention Identify Risk & Protective Factors Identify the Harm Public Health Approach Evaluate Impact Anticoagulants Insulins NTI Medicines

42. http://www.healthypeople.gov/HP2020/Objectives/  4 proposed Sub-objectives

43. 3. Patient-centered Prevention Partnerships

44. Budnitz DS et al. JAMA 2006;296:1858-1866 ADEs Treated in EDs by Patient Age, United States, 2004-2005

45. Unintentional Overdoses Cause Most Emergency Visits in Children <5 Years Old TypePercent Unintentional Overdoses 58% Allergic Reactions28% Side Effects 5% Vaccine Reactions 8% Secondary Effects 1% Cohen AL, et al. J Pediatr 2008;152: 416-421

46. Rates of Emergency Department Visits for Unintentional Overdoses, 2004-2005 Schillie SF et al. Am J Prev Med 2009;37:181-7

47. Rates of Emergency Department Visits for Unintentional Overdoses, 2004-2005 Schillie SF et al. Am J Prev Med 2009;37:181-7 1 out of every 180 two-year-olds each year

48. Underlying Causes of Emergency Department Visits for Child Overdoses, 2004-2005 Schillie SF, et al. Am J Prev Med 2009;37:181-7

49. Underlying Causes of Emergency Department Visits for Child Overdoses, 2004-2005 Schillie SF, et al. Am J Prev Med 2009;37:181-7

50. Underlying Causes of Emergency Department Visits for Child Overdoses, 2004-2005 Schillie SF, et al. Am J Prev Med 2009;37:181-7

51. PROTECT Partnership Preventing Overdoses & Treatment Errors in Children Taskforce Federal agencies, manufacturers (OTC), professional organizations, safety experts  Innovative safety packaging (↓ ingestions)  Standardize dosing units and abbreviations for liquid medicines (↓ errors)

52. Packaging Innovations to Reduce Pediatric Ingestions Active Passive

53. Principles of Standardization & Health Literacy http://www.chpa-info.org/scienceregulatory/Voluntary_Codes.aspx

54. Tamiflu Suspension Medication-safety efforts in ambulatory settings must recognize the central role of patients and lay caregivers in medication management. Instructions and labeling should be clear, concise, consistent, and designed for the way prescriptions are written and used. As highlighted by Parker et al., dispensing liquid medications with dosing devices with markings that match the units used in the instructions on the pharmacy label is one necessary step toward safer medication use.

55. Design Intervention Identify Risk & Protective Factors Identify the Harm Improving packaging, labeling - 1 in 180 two-year olds - Unsupervised ingestions 98,000 ED visits/year for children <=5 years old Public Health Approach for Medication Safety

56. http://www.healthypeople.gov/HP2020/Objectives/  4 th proposed Sub-objective

57. 1.Injury-based approach to medication safety –Identify the harms 2.Population-based harm data for priority setting – Identify common, serious, preventable harms 3.Patient-centered interventions – Use opportunities, collaboration & lessons of injury prevention Summary

58. Acknowledgements Division of Healthcare Quality Promotion, CDC Nadine Shehab Kelly Weidenbach Victor Johnson Melissa Schaefer Maribeth Lovegrove Michael Jhung Daniel Pollock Sarah Schillie Chesley Richards Center for Drug Evaluation and Research, FDA Karen Weiss Solomon Iyasu Gerald Dalpan Judy Staffa Pamela Scott Mary Willie Margie Goulding Charles Ganley Sue Johnson US Consumer Product Safety Commission Tom Schroeder Joel Freidman Cathleen Irish TM

60. Additional Slides

61. Antibiotics –7 of the top 14 drugs implicated in ED visits for ADEs –142,000 ED visits/year –~ 80% are allergic reactions Risks of adverse events from antibiotics incorporated into national campaign to promote judicious antibiotic use –CDC Get Smart Implications for Antibiotic Use Budnitz DS, et al. JAMA 2006;296:1858-66. Shehab N, et al. Clin Infect Dis 2008;47:735-43.

62. OTC Medicines are Commonly Involved in Emergency Visits for Overdoses Schillie SF, et al. Am J Prev Med 2009;37:181-7.....

63. Example: Innovations to Reduce Needlesticks Active Passive

64. Drug Management by Setting Hospital Who prescribes?MD Who administers?RN Who stores?PharmD Who monitors?MD, RN, PharmD, Lab Support systems?Extensive ADE monitoring?Incident reporting Basis for safety interventions? Systems engineering Industrial quality control Budnitz DS and Layde PM. Pharmacoepidemiol Drug Saf. 2007;16:160-5

65. Drug Management by Setting HospitalAmbulatory Who prescribes?MDMD & Layperson Who administers?RNLayperson Who stores?PharmDLayperson Who monitors?MD, RN, PharmD, LabLayperson & MD Support systems?ExtensiveMinimal ADE monitoring?Incident reportingPublic health surveillance Basis for safety interventions? Systems engineering Industrial quality control Injury Prevention Strategies Budnitz DS and Layde PM. Pharmacoepidemiol Drug Saf. 2007;16:160-5

66.  Ongoing surveillance based on chart abstraction NEISS-CADES: Data Collection

67. Setting: only ED visits – No inpatient follow-up or mortality Underestimates – Relies on caregiver recognition, physician documentation, and accurate abstraction – High PPV, lower sensitivity Selection biases – Acute onset ADEs – ADEs which can be diagnosed in ED Limitations

68. 1. Look in Diagnosis Section of chart: Do diagnoses include key words? Allergic reaction Adverse effect Side-effect (s/e) Secondary to (2°to, due to, related to) Ingestion (poisoning) Toxicity (overdose, supra-therapeutic level) Medication error Or suspicious symptoms? Angioedema (face/lip/throat swelling) Anaphylaxis (severe allergy) Rash (urticaria, dermatitis) Bleeding (GI Bleed, hematemesis, epistaxis, hypocoaguability, high INR/PT) Hypoglycemia (low blood sugar) 2. Is a Drug involved? Drugs include: prescription meds, over-the-counter meds, vaccines, vitamins, & dietary supplements. Identifying ADE Cases YES NO 3. Is there evidence of: Suicide attempt? Intentional overdose? Abuse / Recreational use? YES 4. Fill out ADE Screen: Record ED chart DIAGNOSIS word for word Record drug name(s) If available, record dose, route, frequency, and duration Record reason for visit, testing, and treatments Record any other information (e.g., discharge instructions or medication error information) YES NO STOP Do not report ADE STOP Do not report ADE START FINISH

69. Drug data –Name of implicated medication(s) –Dose, frequency, duration, route –Concomitant drugs Patient demographics Testing and treatments in ED Physician diagnoses Patient disposition Narrative description of event Recording Case Data

70. Design Intervention Identify Risk & Protective Factors Identify the Problem Insulin, Warfarin Older Adults - 2x rate ED visits - 7x hospitalization rate 256,000 ED visits in 2008 Public Health Approach for Medication Safety

71. Identify Plausible Interventions Phase-Factor Matrix Factor Phase Host (Patient) Agent (Drug) Environment Pre-event Event Post-event

72. Preventing Adverse Events from Warfarin Budnitz DS and Layde PL Pharmacoepidemiol Drug Saf 2007;16:160-5