Federal Interagency Workgroups for Adverse Drug Events

1. Federal Interagency Workgroups for Adverse Drug Events Federal Interagency Workgroups for Adverse Drug Events: A Path Toward a National Action Plan for Prevention Presentation to the ONC Health IT Policy Committee Quality Measures Workgroup Monday, June 3rd, 2013 U.S. Dept of Health & Human Services (HHS) http://www.hhs.gov/ Office of the Assistant Secretary for Health http://www.hhs.gov/ash/ Office of Disease Prevention and Health Promotion http://odphp.osophs.dhhs.gov/

2. Participating Federal Partners Participating Federal Partners Office of the Assistant Secretary for Health Administration on Aging Agency for Healthcare Research and Quality Assistant Secretary for Planning and Evaluation Bureau of Prisons Centers for Disease Control and Prevention Centers for Medicare & Medicaid Services Department of Defense Food and Drug Administration Health Resources and Services Administration Indian Health Service National Institutes of Health Office of Disease Prevention and Health Promotion Office of the National Coordinator for Health IT Veterans Health Administration

3. ADEs – Opportunity for Impact ADEs – Opportunity for Impact Yael Harris, PhD, MHA Office of Disease Prevention and Health Promotion

4. ADEs Adverse Drug Events (ADEs) • Harms to patients that occur during medical care • Patient safety and public health challenge owing to associated morbidity, costs, and preventability • Largely unaddressed in coordinated, aligned, and targeted fashion across federal agencies

5. ADEs ADEs – Opportunity for Impact • Most common causes of inpatient complications  prolong length-of-stay and increase costs • Affect ~1.9 million hospital stays annually • Add 1.7 to 4.6 hospital days • Cost $4.2 billion USD annually INSIDE the hospital • Classen DC et al. Health Aff (Millwood) 2011;30:581–9. • Agency for Healthcare Research and Quality, Rockville, MD, 2011 April. HCUP Statistical Brief #109. • Classen DC et al. JAMA 997;277:301–6. Bates DW et al. JAMA 1997;277:307–11.

6. ADEs as Causes of Inpatient Complications ADEs as Causes of Inpatient Complications • ~63% of ADEs: • Excessive bleeding (anticoagulants) • Delirium or change in mental status (opioids, benzodiazepines) • Hypoglycemic event (insulin, oral hypoglycemics) • ~50% of ADEs judged to be preventable HHS Office of Inspector General (OIG). Washington, D.C., 2010 November. Report No.: OEI-06-09-00090.

7. ADEs as Causes of Outpatient Complications ADEs as Causes of Outpatient Complications • ADEs responsible for ~100,000 emergent hospitalizations in older Americans, annually • ~ Two-thirds resulting from just four medication classes (anticoagulants, insulin, oral hypoglycemics, antiplatelets) • ~ Two-thirds resulting from unintentional overdoses (or supratherapeutic effects) • Budnitz DS et al. N Engl J Med 2011;365:2002–12.

8. ADEs as Result of Care Transitions ADEs as Result of Care Transitions • Most common causes of post-discharge complications • Comprise ~two-thirds of post-discharge complications* • Comprise ~one-half of preventable post-discharge complications From INSIDE to OUTSIDE the hospital • Forster AJ et al. Ann Intern Med 2003;138:161–7. • *Within 3 weeks of hospital discharge.

9. ADEs ADEs – Opportunity for Impact • Important contributors to outpatient complications OUTSIDE the hospital Hospital Admissions ~125,000 Emergency Dept Visits ~1 million Physician Office Visits ~ 3.5 million Annually • Bourgeois FT et al. Pharmacoepidemiol Drug Saf 2010;19:901–10. • CDC, unpublished data. Update to Budnitz DS et al. JAMA 2006;296:1858–66.

10. FIW for ADEs Federal Interagency Workgroups (FIW) for ADEs Yael Harris, PhD, MHA Office of Disease Prevention and Health Promotion

11. The Charge The Charge • Initiate discussions that identify coordinated approaches to ADEs • Surveillance and measurement • Evidence based prevention • Incentives and Oversight • Research Needs • Focus on drug classes associated with ~two-thirds of ADEs • Incorporate approaches into National Action Plan for ADE Prevention

12. Organization Organization • Federal Interagency Steering Committee for Adverse Drug Events Health IT Health IT Health IT Health IT Health IT Health IT Health IT Health IT Health IT Health IT Health IT Health IT

13. Stage 2 MU • Currently, very few MU requirements targeted at ADEs MU Meaningful Use VTE Venous thromboembolism

14. Office of the National Coordinator (ONC)Electronic Health Record (EHR)Meaningful Use (MU) Stage 3 Requirements

15. FIW for ADEs – Anticoagulants FIW for ADEs – Anticoagulants Nadine Shehab, PharmD, MPH Centers for Disease Control and Prevention

16. Anticoagulation Safety EHR Recommendations:Eligible Providers Patient Lists • Patient lists stratified by INR testing interval (30 days, 60 days, 90 days, 90+) Clinical Decision Support (CDS) • If no INR test in past 30 days, recommend evaluation for INR re-testing • Notification when individual on warfarin prescribed new anti-infective medication • Percent of patients on anticoagulants with INR test 7 -14 days following out-of-range INR Quality Measure Concepts

17. Patient List • List of patients on warfarin stratified by time since last INR test • Justification: Allows providers to re-evaluate need for follow-up INR test based on individual patient’s needs (e.g., concomitant medications, co-morbidities, dose, diet)

18. Anticoagulation Safety Current National Measures • NQF-endorsed measures: • NQF 0555: Lack of monthly INR monitoring • NQF 0556: INR test 3-7 days after new anti-infective medication • 2012 ACCP (Chest) Guidelines: • For patients taking VKA therapy with consistently stable INRs…[recommend] INR testing frequency of up to 12 weeks • For patients taking VKAs…avoid concomitant treatment with…certain antibiotics National Quality Forum. NQF Endorsed Patient Safety Measures. Available at: www.qualityforum.org/topics/overview_of_safety_measures.aspx. Holbrook A et al. Chest 2012;141:e152S-e84S.

19. Quality Measure Concept • Justification: Anticoagulation control, as measured by Time in Therapeutic Range (TTR), isimproved by prompt, repeat testing after out-of-range INR values Holbrook A et al. Chest 2012;141:e152S-e84S. Rose AJ et al. Circ CardiovascQual Outcomes 2011;4:276-82. Schulman S et al. Thromb Res 2010;125:393-7.

20. Clinical Decision Support # 1 • Clinical reminder to assess need for INR test • Indications: • Patients currently on warfarin therapy • AND • > 30 days since last INR test

21. Proposed CDS Display Proposed CDS Display

22. Clinical Decision Support # 2 • Notification when patient on warfarin prescribed new interacting anti-infective medication • Indications: • Patients currently on warfarin therapy • AND • Initiated treatment with new anti-infective medication

23. Proposed CDS Display

24. Anticoagulation Safety EHR Recommendations:Eligible Hospitals EHR Functionality/ Usability • Electronic anticoagulation management flowsheet • Lab results (e.g., INR, PTT, anti-factor Xa, Hgb, Hct, SCr) linked to • Pharmacy data (agents, doses) • Key elements: • linked lab-pharmacy data in single view • real-time • Justification: complexity, acuity of hospitalized patients require informed, individualized decision-making by providers on rapidly-changing clinical and laboratory parameters

25. Example Inpatient Anticoagulant Flowsheet

26. EHR Requirements: Current Gaps in Anticoagulation Safety • Newer oral anticoagulants (e.g., dabigatran, rivaroxaban) • Dosing, adherence, and transition from warfarin • Parenterally-administered anticoagulants (esp. hospital uses) • Pertinentlaboratory monitoring parameters • Outcomes-based metrics • Bleedingevents • Transitions of care-related metrics • Communication and hand-off Evolving and early science Lack of consensus, uniformity across sites Limitations in diagnostic coding Complex process metric

27. Q & A

28. FIW for ADEs – Diabetes Agents FIW for ADEs – Diabetes Agents Leonard Pogach, MD, MBA, FACP Department of Veterans Affairs Cindy Brach, MPP Agency for Healthcare Research and Quality Mary Andrawis, PharmD, MPH Centers for Medicare and Medicaid Services

29. Diabetes AgentsEHR Recommendations:Eligible Providers Data Elements • Record co-morbid conditions Patient Lists • Stratify patients by specific lab values and certain risk factors • Overtreatment measure Quality Measure Concepts Clinical Decision Support (CDS) • Addressing potential risk for hypoglycemia • Shared Decision Making • Action Plan for prevention of hypoglycemia

30. Data Elements & Patient Lists

31. Examples as used by VA

32. Quality Measure Concept

33. Clinical Decision Support # 1

34. Proposed CDS Display Proposed CDS Display

35. Clinical Decision Support # 2

36. Proposed CDS Display: Example used by VA Proposed CDS Display VISN 12 Experience Department of Veterans Affair Shared-Decision Making and Hypoglycemia Risk Reduction in Type 2 Diabetes

37. Clinical Decision Support # 3

38. Proposed CDS Display Proposed CDS Display

39. Diabetes Agents Patient EngagementEP: Recommendation 1

40. Diabetes Agents Patient EngagementEP: Recommendation # 2 Example: Mr. Smith’s A1c Levels NOTE: Individualized goal decided on by both provider and patient

41. Diabetes AgentsEHR Recommendations:Eligible Hospitals Data Display • Display of pertinent information for prevention of hypoglycemia Quality Measure Concepts • Hypoglycemia, severe • Hyperglycemia • Hypoglycemia, Mild • Recurrent Hypoglycemia Clinical Decision Support (CDS) • Notification of occurrence of repeated hypoglycemia

42. Data Display Data Display

43. Proposed Data Display Proposed Data Display

44. Quality Measure Concept #1

45. Quality Measure Concept #2

46. Quality Measure Concept #3

47. Quality Measure Concept #4

48. Clinical Decision Support

49. Proposed CDS Display Proposed CDS Display

50. Q & A