ADEs and RCAs: Reports and insight from the frontline

1. ADEs and RCAs:  Reports and insight from the frontline Francesca Cunningham , Pharm.D. Associate Chief Consultant Center for Medication Safety and PBM Services Bruce McIntosh, Pharm.D. Patient Safety Pharmacist VA National Center for Patient Safety

2. ADEs and RCAs: Root Cause Analysis Bruce McIntosh, Pharm.D. Patient Safety Pharmacist VA National Center for Patient Safety

3. 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

4. WHAT is a RCA? 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. RCA (The NCPS Model) • 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. RCA (continued) Whose fault is it? Who do we blame? How did we get here? How do we prevent it from happening again? Questions typically asked in healthcare: Questions typically asked in high reliability organizations: !

7. N = 270 Actions Communication – 24% Training – 11% Policies & Procedures 43% Physical Plant Design/ Layout5% Equipment or Software 14% Actions Identified by RCA Teams NA = 3% REASON, J. (1997) Managing the risks of organizational accidents, Hampshire, England, Ashgate Publishing Limited.

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

9. VA Root Cause Analysis (RCA) SPOT Database Barriers 11.0% Environment/Equipment 12.8% Communication 28.5% Fatigue/Scheduling 8.2% Training16.4% Rules/Policies/Procedures 23.2% Total: 100.0% 14,997 21,228 7,539 10,070 • 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. 26,150 11,694 VA National Center for Patient Safety SPOT Database. Accessed Sept. 22, 2011.

10. 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 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.pdf

11. 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. Adverse Events and Close Calls Draft 2012 NCPS analysis FY06 through FY11

13. 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%) Draft 2012 NCPS analysis

14. 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

15. 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)

16. Reaching for High Reliability 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. 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. OVERVIEW • Overview of VAMedSAFE Goals • Surveillance and Monitoring • VA ADERS • Database Surveillance • Risk Reduction Efforts and Assessment • Brief Overview of MUET System

19. 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. Adverse Drug Events in VAReporting, 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. EXAMPLE OF VA ADERS

22. VA ADERS NATIONAL DATABASEProgram 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. American Journal of Health-System Pharmacy February 15, 2012 vol. 69 no. 4 321-328

24. 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. 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

26. 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. 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. The VA as a resource for active surveillance and adverse event evaluation Older/Sicker patients High medication use Good Information Systems Surveillance in VA

29. PHARMACOVIGILANCE AND DRUG SURVEILLANCE USING INTEGRATED DATABASES • SELECTED EXAMPLES OF VAMedSAFE PHARMACOVIGILANCE / SURVEILLANCE PROJECTS • Antipsychotics • TZDs • High Dose Statins • PPIs • Opioids • Dronedarone • Dabigatran • Vaccines

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 CONCLUSION

33. 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. Dronedarone • Patients prescribed dronedarone through 2nd quarter of fiscal year 2011 • # patients exposed • Evaluation • Inappropriate prescribing in HF pts • Exacerbation of HF • New Onset HF

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. 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. Glyburide Risk Reduction

39. Glyburide Intervention Assessment • Goal • To assess outcomes secondary to intervention • Outcomes • Glycemic Control • Severe Hypoglycemia • Subgroup Analysis (severe RI)

40. Glyburide Intervention Assessment Results

41. Glyburide Intervention AssessmentConclusions • 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. MUE PROCESS

43. MEDICATION USE EVALUATION TRACKER (MUET) 326 MUET Users 336 Sites (Parent facilities, CBOCs, etc) 21 VISNs

44. 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. MUET – Criteria and Goals Glyburide Criteria • Patients with active glyburide • 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. 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. QUESTIONS