Inpatient Adverse Drug Events Suck- What Lucile Packard Childrens Hospital Did to Decrease Them by 70

1. Inpatient Adverse Drug Events Suck-What Lucile Packard Children's Hospital Did to Decrease Them by 70% Paul Sharek, MD, MPH Medical Director of Quality Management Chief Clinical Patient Safety Officer Lucile Packard Children�s Hospital

2. Why talk about Patient Safety and Adverse Drug Events? Institute of Medicine report (1999) Data is flat out disturbing 44,000-120,000 deaths/yr in US hosp (est) 7,000 deaths/yr from medication errors in US (est) Compared to 45,000 deaths in car accidents Costly (LOS, malpractice) Lay press/public (credibility) JCAHO Medical systems increasingly complex Problem ain�t going away Malpractice claims: highest total expenditure of any type of procedure related injuryMalpractice claims: highest total expenditure of any type of procedure related injury

3. Comparative Reliability Between Industries

4. Comparison to Airline Industry Mortality rate: 0.27 per 1 million departures To reach 50% chance of injury, estimated require 20,000 continuous years of flying Medical error mortality rate = one 747 crash per day

5. Paul�s Worst Nightmare

6. LPCH CEO, COO Worst Nightmare

7. Adverse Drug Event (ADE) Any injury caused by a drug. Includes injuries caused by errors and adverse drug reactions Includes preventable and not-preventable events ADE = preventable ADE + ADR

8. Background Data: Medication ERRORS in Children

9. �Error� definition bears upon concept of preventability, and is therefore process-focused �Adverse event� describes harm to the patient, and is thus outcome focused Relationship between errors and adverse events:

10. Background Data: Medication HARM in Children Child Health Corporation of America: Adverse Drug Event (ADE) trigger tool trial 12 children�s hospital 2001 and 2002 Results 15.7 ADEs per 1000 patient days 93% of preventable ADEs in monitoring and prescribing/ordering phases 23x more likely to identify an event than incident reports Opiates most problematic

11. Triggers: Pediatric Trigger Tool

12. Adverse Drug Events: Drug Class

13. Adverse Drug Events: Where

14. LPCH (2001-2002) Baseline data Culture of safety data- RFI* Incident reports- RFI* Adverse drug event rates-RFI* Patient Safety Infrastructure-under construction Board of Directors starting to sense the patient safety movement

15. Adverse Drug Event Rates @ LPCH (2001-2002)

16. Incident Reports Related to Medication Errors (2001-2002)

17. Culture of Safety (2001-2002)

18. PAUL SHAREK Can talk about these as time permits�PAUL SHAREK Can talk about these as time permits�

19. What Paul felt like when he spoke to LPCH Leadership (Board, Medical Board, �) about Patient Safety

20. LPCH Board of Directors (2001-2002) #1 Priority Goal (FY2002, FY2003): Decrease Adverse Drug Events from 10.2 to 6.0/1000 patient days

21. INTERVENTIONS

22. Patient Safety Infrastructure Personnel Chief Clinical Patient Safety Officer appointed Patient Safety Program Manager funded 1.0 FTE Reporting structure redesigned Board committee for Quality and Safety Safety data reported quarterly to the Board Increased data sharing between leadership and staff Resources started to flow Increased accountability

23. Multi-faceted Approach to ADE Reduction Culture of Safety focus Medication Management Redesign High risk medication management focus AHRQ �partnerships in quality� grant funded collaborative projects

24. Track 1: Culture of Safety Development Patient Safety Program Manager hired Increased RCAs (using near misses)/FMEAs Purchased and implemented electronic incident reporting system Increased reporting Easier trending Initiated Safety Action Teams with 60+ volunteer Patient Safety Champions

25. Track 1: Culture of Safety Development Safety walk-a-rounds and Executive walk-a-rounds Roped in Medical, Administrative, and Board leadership into caring and instilling accountability Tracking and transparency of patient safety data/culture of safety data Tightened up Staff to Board and back to Staff reporting/accountability loops

26. Reporting Structure-Patient Safety Data and Projects at LPCH

27. Reporting Structure-All Reviewable Events at LPCH

28. Medication Management Process at LPCH similar to�

29. Track 2: Medication Management Redesign-the Highlights Patient Specific Information Intranet based patient medication teaching Selection/Procurement/Storage Reviewed/revised look alike, sound alike drug storage/labeling *Prescribing and Transcribing Preprinted orders (standardized format, eliminated abbreviations, max dosing, generic names only, removed ambiguity, placed on inTRAnet)

30. Track 2: Medication Management Redesign-the Highlights (cont.) Preparing and Dispensing Pyxis implementation *Monitoring ADE data tracked by Pt Safety Committee, P and T, Medical Board, LPCH Board Evaluation 27 Quality Indicators determined LPCH Board priorities

31. Track 3: High Risk Medication Management TPN overhaul Process redesign (FMEA) Software upgrade (windows based, min/max dosing) Automated compounding: BAXA2400 Potassium task force Standardized concentrations Required pre-printed order set for infusions Narcotics/analgesic focus Eliminated multiple morphine PCA concentrations PCA pre-printed order sets developed and required Corollary order�s project

32. TPN automated compounder @ LPCH

33. Track 4: AHRQ PFQ grant funded projects Reducing errors in handoffs (ED to inpatient setting) Reducing Adverse Drug Events related to opiates Reducing Central Line Associated BSIs

35. Aim Statement To reduce errors and adverse events related to the communication of patient information at the time of patient transfer from the emergency department to a general medical/surgical unit by year end 2004. This will be accomplished by utilizing a communication checklist to reach the following goals: Reduce early or late medications by 75% Reduce duplicate or missed lab tests by 50% Reduce errors in isolation by 50%

36. Collaborative Results

37. Aim and goals: ADE collaborative

38. Aim and goals: Cath Assoc BSI collaborative

39. RESULTS

40. Adverse Drug Event Rates: LPCH (2001-2005)

41. Pharmacy Interventions-LPCH (2001-2004)

42. Pharmacy Interventions-TPN related

43. Process Redesign-TPN @ LPCH

44. % Incident Reports Related to Medication Safety (2001-2004)

45. Results: % Incident Reports Related to Medication Safety (2001-2004)

46. Results: % Incident Reports Related to Medication Safety (2001-2004)

47. Culture of Safety (2002-2004)

48. Sometimes the transition wasn�t all that smooth�

49. Conclusions Backdrop in 2002 Increasing patient safety awareness national/LPCH Baseline data/CHAI ADE trigger tool Interventions: 3 tracks Culture of Safety focus Medication Management Redesign High risk medication management focus Results Decrease pharmacy intervention rates/TPN interventions Decreased % incident reports related to medication safety Streamlined medication administration processes Decreased ADEs by 70% 3 inpatient kids/DAY less harmed 1 inpatient kid/MO less die (Estimated based on 1% mortality in literature)

50. LPCH Words of Wisdom� Valid and reproducible outcome measure is critical (ADE rates using CHAI trigger tool) Critical role of governance, administrative and medical leadership Processes that minimize steps/save time are more likely to succeed (ex. Standardized pre-printed orders sets) Automate all possible steps in the medication management process (ex. TPN software and compounder) Forcing functions substantially improve medication safety (ex. CHAI corollary order project)

51. Final Words of Wisdom: It�s All About Adverse Event Prevention