1. Medication Use Crisis Sponsored by the VA Medication Reconciliation Initiative In conjunction with VHA Program Offices, DoD and IHS ADEs and RCAs: Reports and insight from the frontline Bruce McIntosh, Pharm.D. Patient Safety Pharmacist VA National Center for Patient Safety Francesca Cunningham, Pharm.D. Associate Chief Consultant Center for Medication Safety and PBM Services

2. Medication Use Crisis Sponsored by the VA Medication Reconciliation Initiative In conjunction with VHA Program Offices, DoD and IHS ADEs and RCAs: Root Cause Analysis Bruce McIntosh, Pharm.D. Patient Safety Pharmacist VA National Center for Patient Safety

3. VETERANS ADMINISTRATION PATIENT CARE SERVICES NCPS Background and Root Cause Analysis (RCA) In 1999, the VA National Center for Patient Safety (NCPS) was established to lead the effort to improve the safety of patients cared for in the VA health system To allow facility, network and VHA-wide learning about adverse events, NCPS developed a standardized method for “root cause analysis” (RCA) The RCA process involves the identification of basic or contributing causal factors to adverse events or close calls, and then using that information to develop actions to address the identified causes and prevent harm to patients in the future 2

4. VETERANS ADMINISTRATION PATIENT CARE SERVICES WHAT is a RCA? 3 Process for identifying contributing/causal factors that underlie variations in performance associated with adverse events or close calls Process that features interdisciplinary involvement of those closest to and/or most knowledgeable about the situation

5. VETERANS ADMINISTRATION PATIENT CARE SERVICES RCA (The NCPS Model) 4 A rigorous, legally protected, and confidential approach to answering: – What happened? (event or close call) What happened that day? What usually happens? (norms) What should of happened? (policies) – Why did it happen? – What are we going to do to prevent it from happening again? (actions) – How will we know that our actions improved patient safety? (outcomes)

6. VETERANS ADMINISTRATION PATIENT CARE SERVICES RCA (continued) Whose fault is it? Who do we blame? How did we get here? How do we prevent it from happening again? 5 Questions typically asked in healthcare: Questions typically asked in high reliability organizations:

7. Physical Plant Design/ Layout 5% Equipment or Software 14% Communication – 24% Training – 11% Policies & Procedures 43% Actions Identified by RCA Teams NA = 3% N = 270 Actions REASON, J. (1997) Managing the risks of organizational accidents, Hampshire, England, Ashgate Publishing Limited.

8. VETERANS ADMINISTRATION PATIENT CARE SERVICES Root Cause Analysis (RCA) Draft 2012 NCPS analysis of the membership of RCA teams from FY06 through FY11

9. 7,539 26,150 14,997 11,694 21,228 10,070 Barriers11.0% Environment/Equipment12.8% Communication28.5% Fatigue/Scheduling8.2% Training16.4% Rules/Policies/Procedures23.2% Total:100.0% VA Root Cause Analysis (RCA) SPOT Database VA National Center for Patient Safety SPOT Database. Accessed Sept. 22, 2011. SPOT Database from 2000-2011 13,120 adverse events studied in detail 9,822 reports cite “communication” as a “triage category” for at least one of the root causes. 75% of adverse events have “communication” as a contributing factor.

10. VETERANS ADMINISTRATION PATIENT CARE SERVICES RCA- Communication Breakdown “Insufficient communication” was the most frequently cited root cause of the nearly 3,000 sentinel events reported to the Joint Commission between 1995 and 2004 Not surprisingly, over 70% of all OR-related sentinel events between 1995 and 2005 cited communication as a root cause 9 Pillars of a Smart, Safe Operating Room,” F. Jacob Seagull, MD; Gerald R. Moses, PhD; Adrian E. Park, MD Retrieved December 16, 2011 from http://www.ahrq.gov/downloads/pub/advances2/vol3/Advances- Seagull_98.pdfhttp://www.ahrq.gov/downloads/pub/advances2/vol3/Advances- Seagull_98.pdf

11. VETERANS ADMINISTRATION PATIENT CARE SERVICES Medication Events from RCAs Summary of Root Cause Analyses Event Types (Not Including Aggregate Review Reports) This graph was created on 02/02/12.

12. VETERANS ADMINISTRATION PATIENT CARE SERVICES Adverse Events and Close Calls 11 Draft 2012 NCPS analysis FY06 through FY11

13. VETERANS ADMINISTRATION PATIENT CARE SERVICES RCA and Medication Events During fiscal year 2008, NCPS received 232 medication-related Root Cause Analysis (RCA) reports and 181 aggregated review reports covering 20,724 Med events reported in FY 2008 The most common reported Med event was omission (18%) 6,607 Actions were recommended to address the problems 4,832 Actions were implemented to date (73%) 12 Draft 2012 NCPS analysis

14. VETERANS ADMINISTRATION PATIENT CARE SERVICES NCPS Medication Safety Improvements Insulin U-500 Safety Enhancements VHA Prescription Label Redesign Epinephrine, Phenylephrine, and other High Alert Medication Safety in the OR Standardized Process for Insulin Orders when used in Subcutaneous Implanted Insulin Pumps Anticoagulation Therapy Management Directive OIA Patient Safety Alerts Other examples 13

15. VETERANS ADMINISTRATION PATIENT CARE SERVICES Examples of Medication Event RCAs from the Frontline Warfarin dosing instructions for new admissions Discharge process and CPRS prescription orders Patient discharged home without IV antibiotics Patient received another patients outpatient medications Non-VA case example (Comparison to VA) 14

16. VETERANS ADMINISTRATION PATIENT CARE SERVICES Reaching for High Reliability 15 Safety Matters 99.9% Reliability = 20,000 incorrect prescriptions every year 500 incorrect operations each week 1 hour of unsafe drinking water every month 22,000 bank checks deducted from the wrong bank account each hour NCPS Curriculum

17. Medication Use Crisis Sponsored by the VA Medication Reconciliation Initiative In conjunction with VHA Program Offices, DoD and IHS ADEs and RCAs: Reports and insight from the frontline: Focus on Pharmacovigilance and Drug Surveillance from the National Level Francesca Cunningham, Pharm.D. Associate Chief Consultant Center for Medication Safety and PBM Services

18. VETERANS ADMINISTRATION PATIENT CARE SERVICES OVERVIEW Overview of VAMedSAFE Goals Surveillance and Monitoring – VA ADERS – Database Surveillance Risk Reduction Efforts and Assessment Brief Overview of MUET System 17

19. VETERANS ADMINISTRATION PATIENT CARE SERVICES GOAL of VA PHARMACOVIGILANCE PROGRAM - VAMedSAFE Track and evaluate high risk and high volume agents in Veteran population Determine rates and risks of ADEs associated with specific agents Maintain the national drug safety program with emphasis on: – Utilizing integrated databases as the foundation of the VA pharmacovigilance program – Enhancing spontaneous ADE reporting for system based changes and enhancement of drug safety efforts – Communicating drug safety information

20. VETERANS ADMINISTRATION PATIENT CARE SERVICES Adverse Drug Events in VA Reporting, Tracking, Monitoring Adverse Drug Event Database (VA ADERS) – Spontaneous Reporting Adverse Drug Event Tracking and Evaluation Using VA Integrated Databases – Prescription Databases – Inpatient/Outpatient Files

21. VETERANS ADMINISTRATION PATIENT CARE SERVICES EXAMPLE OF VA ADERS 20

22. VETERANS ADMINISTRATION PATIENT CARE SERVICES VA ADERS NATIONAL DATABASE Program Goals Standardized reporting – To VA, FDA MedWATCH and FDA VAERS (vaccines) Centralized – Database contains records on 284,587 Reports and 403,125 symptoms (through April 17, 2012) Tracking and Trending reports Web-based reporting >> 3761 Reporters at 150 facilities in 22 VISNs (21 VISNs plus CMOP) Surveillance and Benchmarking Process Improvements

23. VETERANS ADMINISTRATION PATIENT CARE SERVICES American Journal of Health-System Pharmacy February 15, 2012 vol. 69 no. 4 321-328 22

24. VETERANS ADMINISTRATION PATIENT CARE SERVICES Recent activity in VA ADERS Report selection for: – Drug: all ADRs/ADEs to drugs, biologics to be reported to VA and when appropriate/required FDA MedWATCH – Vaccine: all events with immunizations to be reported to FDA Vaccine Adverse Event Reporting System (VAERS) Monitoring – contributions to overall surveillance activities

25. VETERANS ADMINISTRATION PATIENT CARE SERVICES Monitoring Past – Heparin – Cholinesterase Inhibitors – Venlafaxine – Spironolactone/Eplerenone – Iron Dextran Current – Vaccines (Influenza) – Varenicline – Dabigatran – Dronedarone – Sentinel events (fatal outcomes) – Niacin Conversion Key element to all monitoring: Reporting from Health Care Practitioners Reporter OccupationReport CountReporter OccupationReport Count NURSE466PHYSICIAN ASSISTANT48 NURSE PRACTITIONER112PROVIDER4,245 OTHER20,364QUALITY MGT1,079 PHARMACIST257,780RADIOLOGY11 PHYSICIAN482

26. VETERANS ADMINISTRATION PATIENT CARE SERVICES ADR Recognition and Reporting Recognizing and documenting ‘observed’ events Increase the “known” reactions – Increases the total of reported reactions Increases opportunity for event EVALUATION – Reporting to FDA MedWATCH program Strengthens Pharmacovigilance efforts

27. VETERANS ADMINISTRATION PATIENT CARE SERVICES VA ADERS Program Focus – Closing the Gap Close the GAP between events that occur and the events that are reported. How? – ARTS Draft Imports process – Educate about ‘Observed’ events – Educate reporters – Educate providers – Educate patients Improve patient safety Increase Reporting!

28. VETERANS ADMINISTRATION PATIENT CARE SERVICES Surveillance in VA The VA as a resource for active surveillance and adverse event evaluation – Older/Sicker patients – High medication use – Good Information Systems

29. VETERANS ADMINISTRATION PATIENT CARE SERVICES PHARMACOVIGILANCE AND DRUG SURVEILLANCE USING INTEGRATED DATABASES SELECTED EXAMPLES OF VAMedSAFE PHARMACOVIGILANCE / SURVEILLANCE PROJECTS – Antipsychotics – TZDs – High Dose Statins – PPIs – Opioids – Dronedarone – Dabigatran – Vaccines 28

30. EXAMPLES

31. Surveillance, Evaluation and Formulary Decision Rapid Cycle Evaluation was developed and completed and results served as a preliminary marker for full pharmacoepidemiologic study Subsequent analysis was designed and conducted - - Formulary Decision Detailed analysis using Registry data and more sophisticated analytic methods conducted

32. Consistent with VA Criteria for Use, rosiglitazone and pioglitazone were most commonly prescribed as 3rd line agents Health risk for rosiglitazone did not support the high percentage level identified in the meta analysis A slight but consistently lower risk was found for pioglitazone compared to rosiglitazone particularly when rosiglitazone was used as third line agent or in combination with insulin CONCLUSION

33. VETERANS ADMINISTRATION PATIENT CARE SERVICES VA Decision Rosiglitazone was removed from Formulary but remained available in the VA healthcare system Pioglitazone became VA’s preferred TZD Criteria for Drug Use updated

34. VETERANS ADMINISTRATION PATIENT CARE SERVICES Dronedarone Patients prescribed dronedarone through 2 nd quarter of fiscal year 2011 – # patients exposed Evaluation – Inappropriate prescribing in HF pts – Exacerbation of HF – New Onset HF

35. Dronedarone All users Dronedarone Incident UsersHF Dx Post Dronedarone Initiation Evaluation period: Cohort within 30 days N(%) within 90 days N(%) within 180 days N(%) No Hx of HF Mild Heart Failure Recent Decompensated HF (Risk Reduction)

36. Risk Reduction and Intervention Assessment Risk Reduction Program was initiated to: – Identify patients receiving medications with a true contraindication for a given disease state or patients requiring a change in medication regimen to enhance patient safety and prevent potential untoward outcomes. Intervention Assessment – Evaluation designed to assess the outcome of a specific intervention (ie, safety intervention, formulary decision)

37. VETERANS ADMINISTRATION PATIENT CARE SERVICES Risk Reduction Projects (Selected Example) Nifedipine (short Acting) – Prototype High Dose Vitamin E Alpha Blocker Monotherapy LABA Monotherapy Ketoconazole/Simvastatin High Dose Zolpidem Glyburide in Elderly with RI

38. VETERANS ADMINISTRATION PATIENT CARE SERVICES Glyburide Risk Reduction

39. VETERANS ADMINISTRATION PATIENT CARE SERVICES Glyburide Intervention Assessment Goal – To assess outcomes secondary to intervention Outcomes – Glycemic Control – Severe Hypoglycemia – Subgroup Analysis (severe RI)

40. VETERANS ADMINISTRATION PATIENT CARE SERVICES Glyburide Intervention Assessment Results

41. VETERANS ADMINISTRATION PATIENT CARE SERVICES Glyburide Intervention Assessment Conclusions The Risk Reduction successfully switched high-risk patients to safer medication alternatives Glycemic control was not significantly impacted Lower rates of severe hypoglycemia in patients at greatest risk (e.g. sCr > 2.9)

42. VETERANS ADMINISTRATION PATIENT CARE SERVICES MUE PROCESS 41

43. VETERANS ADMINISTRATION PATIENT CARE SERVICES MEDICATION USE EVALUATION TRACKER (MUET) 42 326 MUET Users 336 Sites (Parent facilities, CBOCs, etc) 21 VISNs

44. VETERANS ADMINISTRATION PATIENT CARE SERVICES MUET is Flexible One access point… -Standard format for recording information and interventions across all facilities -Diverse: Each initiative has its own criteria, interventions

45. VETERANS ADMINISTRATION PATIENT CARE SERVICES MUET – Criteria and Goals Glyburide Criteria 1. Patients with active glyburide 2. Age > 65 and serum creatinine > 2.0 mg/dl Program GOALS Identify high risk patients Provide secure list to sites Trigger opportunity for interventions Track interventions Overall Risk Reduction

46. VETERANS ADMINISTRATION PATIENT CARE SERVICES Feedback from MUET Users MUET is a Useful Tool to:  Identify high risk patients needing intervention (increased patient safety)  Operationalize prescribing protocol  Document interventions and workload  Increase awareness of pharmacy managed monitoring service  Benchmark facilities with management programs vs. facilities without  Meet JC requirements

47. VETERANS ADMINISTRATION PATIENT CARE SERVICES QUESTIONS 46