Pediatric Adverse Drug Events Presentation

1. Pediatric Adverse Drug Events
Webinar
April 17th, 2017
Ariana Longley and Jordan Gamart
Patient Safety Movement Foundation
Featured Speakers:
Dr. Anne Lyren, Children’s Hospitals’ Solutions for Patient Safety
Dr. James Broselow, eBroselow

2. Agenda
• Introduction to Patient Safety Movement Foundation and
Actionable Patient Safety Solutions (APSS)
• Pediatric Adverse Drug Event APSS Executive Checklist
• Patient Safety Movement Partner Presentations
– Anne Lyren - Children’s Hospitals’ Solutions for Patient
Safety
– Jim Broselow - eBroselow
• Q&A

3. Patient Safety Movement Foundation
• Founded in 2013 by Joe Kiani
• Mission: ZERO preventable deaths by 2020
• Connecting the dots between all stakeholders across
the healthcare ecosystem

4. 1. Unify the healthcare ecosystem (hospitals, healthcare technology companies,
government, patient advocates, clinicians, engineers, etc.)
2. Identify the challenges that are killing patients to create actionable solutions
3. Ask hospitals to implement Actionable Patient Safety Solutions (APSS)
4. Promote transparency and aligned incentives
5. Ask healthcare technology companies to share the data their devices generate in order
to create a Patient Data Super Highway to help identify at-risk patients
6. Promote patient dignity & love
7. Empower providers, patients, and families through education of medical terminology
and medical errors so they may better advocate for their loved ones
Our Guiding Principles:

5. Actionable Patient Safety Solutions
(APSS)
1. Culture of Safety
 Download at patientsafetymovement.org
2. Healthcare-
associated Infections
(HAIs)
5. Anemia +
Transfusions
8. Airway Safety
3. Medication
Errors
9. Early Detection &
Treatment of Sepsis
6. Hand-off
Communications
11. Optimizing
Obstetric Safety
10. Optimal
Resuscitation
7. Neonatal Safety
4. Failure to Rescue:
Monitoring for Opioid
Induced Resp. Dep.
13. Mental Health
12. Venous
Thromboembolism
(VTE)

6. Executive Summary Checklist
An effective program to reduce the incidence of pediatric adverse drug events (pADEs) and
harm should be instituted and combine leadership strategies, software (healthcare IT),
hardware (drug compounding systems, drug delivery technology, and physiological
monitoring systems), and most importantly people (changes in clinical practice, protocols and
education) in protecting pediatric patients by focusing on the following key tasks:
▢ Demonstrate board and executive leadership engagement and commitment by aligning
hospital-wide strategic goals, accountability and systems to reduce pADEs.
▢ Create a multidisciplinary team specialized in neonatal and pediatric medicine that
reports regularly to executive leadership, with a focus on pADE.
▢ Institute an effective software program for identifying, detecting, and reporting pADEs
with analysis of the incidence and characteristics of pADEs and the near-misses.
▢ Deploy a closed loop medication administration system by implementing an electronic
medication administration record (eMAR) and barcoding, or other auto identification
technology with computerized provider order entry (CPOE) and pharmacy for medication
administration.
▢ Institute proven interventional bundles for pADEs:

7. ▢ Select and implement new enterprise clinical information systems and electronic health
records, verify and assess that the features of an organizations healthcare IT system
includes full support for best practices in age and weight specific prescribing,
compounding, dispensing and administration of pediatric medications
▢ Consider relevant improvement initiatives and opportunities for collaboration in pADE
reduction outside of the hospital system
▢ Disseminate pediatric-specific assistive technologies such as eBroselow (or equivalent) to
assure the basic capabilities to stabilize and treat acutely ill or injured children are present
24/7 throughout all environments of care
▢ Ensure that the FDA Safety Communication: “Syringe Pump Problems with Fluid Flow
Continuity at Low Infusion Rates can Result in Serious Clinical Consequences” is reviewed
and understood by the team.
▢ Utilize Continuous Quality Improvement (CQI) software from infusion pump manufactures
to monitor drug library parameters on a routine basis and to report the frequency of
command overrides and alerts triggered for unsafe practices

8. Anne Lyren, MD, MSc
Clinical Director, Children’s Hospitals’ Solutions for Patient Safety
Strategic Advisor, Quality & Safety, UH Rainbow Babies & Children’s
Hospital
Associate Professor, Pediatrics & Bioethics, Case Western Reserve
University School of Medicine

10. Mission
Working together to
eliminate serious harm
across all children’s
hospitals

11. By December 31, 2018:
o 40% Reduction in Hospital Acquired Conditions*
o 20% Reduction in 7 Day Readmissions*
o 50% Reduction in Serious Safety Event Rate
By June 30, 2019:
o 25% Reduction DART – Days Away Restricted or Transferred
by June 2019
SPS National Network Targets

12. VENTILATOR-ASSOCIATEDEVENTS
ADVERSEDRUGEVENTS
C.DIFFANDANTIMICROBIALSTEWARDSHIP
CA-URINARYTRACTINFECTIONS(CAUTI)
CLA-BLOODSTREAMINFECTIONS(CLABSI)
PERIPHERALINTRAVENOUSEXTRAVASATIONS(PIVIE)
PRESSUREINJURIES(PI)
SERIOUSFALLS
SURGICALSITEINFECTIONS(SSI)
UNPLANNEDEXTUBATIONS
VENOUSTHROMOEMBOLISM(VTE)
SAFETY GOVERNANCE (SG) & CAUSE ANALYSIS (CA)
READMISSIONS
PATIENT AND FAMILY ENGAGEMENT (PFE)
LEADERSHIP METHODS (LM)
ERROR PREVENTION (EP)
DISCLOSURE
40% reduction in pediatric HACs and 20% reduction
in the readmit rate across SPS by 12/31/18
50% reduction in
SSEs by 12/31/18
25% reduction in
DART by 6/30/19
EMPLOYEE/STAFF SAFETY

13. SPS Prevention Bundles
o Surgical site infections
o Serious falls
o Pressure injuries
o Central line-associated blood stream infections
o Catheter-associated urinary tract infections
o Readmissions
o Adverse Drug Event Roadmap (launching 5/17)

14. ADE Roadmap:
Background
o Cohort of 20 SPS hospitals
o Planned experimentation model
o June ‘14 – Dec ’16
o Tested factors associated with all phases of medication
delivery system
o Reviewed available peer-reviewed literature

15. ADE Roadmap: Results
o Significant ADE reduction
o 13 system-level elements associated with decreased
harm
o 3 additional – widely implemented, no further
analysis
o ADE Prevention Roadmap

16. ADE Reduction
o NCC MERP Level E:
• Cohort rates dropped by 62%
(vs. 29% non-cohort)
• From 1 ADE every 2,660 to 1 every 6,993 days
• NCC MERP Levels E
o Cohort rates dropped by 71%
vs. 35% non-cohort
o From 1 ADE every 13,158 days to 1 every 45,555
days

17. ADE Roadmap Elements
Ordering
o Medication reconciliation
o Standard order sets
o Dose range checking
o Ordering through CPOE
o Alert fatigue reduction
o Pharmacist on rounds
o Pharmacy intervention database

18. ADE Roadmap Elements
Dispensing
o Independent verification
o Dispensing cabinet/Omnicell overrides

19. ADE Roadmap Elements
Administration
o Barcode-assisted medication administration
o Smart pumps/guard rails
o Smart pump data analysis
o Standard medication hand-off process at shift change

20. ADE Roadmap Elements
Recommended (not tested)
o 5 Rights
o Independent double check for high-risk medications
o Basic alerts to avoid common ordering issues

21. ADE Roadmap Next Steps
o May, 2017 – Launch to entire SPS Network at
Learning Session
o Hospitals conduct a self-assessment
o Baseline and annual hospital survey re: use of
Roadmap elements
o Numerous collaborative learning opportunities
o Eliminate ADEs!

22. eBroselow
James Broselow, MD
Clinical Associate Professor of Emergency Medicine,
University of Florida College of Medicine
Developer, Broselow Tape and Color Coding Crash
Carts
CMO, eBroselow

23. The Challenge

24. First “Lean”
Clinical System

25. Lessons Learned
Standardization + Simplification = Safety

26. In the
beginning
…
Acute drug administration
was simpler.

27. In the
beginning
…
o Only a few drugs
o Ordered and
administered by
Physician

28. As time
Passed…
o More Drugs
o Ordered by physician
o Administered by nurses

29. As time
Passed…
o Still Safe
o Physician and nurse present
at bedside
o Direct communication
o Shared Knowledge

30. As more time
Passed…
o Relatively safe
o Few indications

31. Modern Hospital Silos
Doctor PharmacistNurse

32. o Knows clinical
indications
o Minimal knowledge of
administration process
Modern Hospital Silos
Doctor Silo

33. o Understands process
o Knows patient
o Can’t possibly check
each drug and
indication every time
Modern Hospital Silos
Nurse Silo

34. o Knows drugs
o Can access encyclopedic
information
o Does not always know clinical
situation
o Mostly not at bedside
Modern Hospital Silos
Pharmacist
Silo

35. “…10 times the proper
dose…”
“…the baby died…”
“…accidental
miscalculation…”
Too many
mistakes…

36. “…1000 times the
dosage…”
Too many
mistakes…

37. “10 times the amount…”
Too many
mistakes…

38. “A three year old boy…”
Too many
mistakes…

39. “This is a system
failure.”
Too many
mistakes…

40. Too much at
stake…

41. In pediatrics, incorrect dosing
is the most common error.
—Crowley E, Williams R, Cousins D.
Medication errors in children: a descriptive summary of medication
error reports submitted to the United States Pharmacopeia.
Curr Ther Res.2001; 26; 627– 640

42. A ten-fold error for an adult:

43. A ten-fold error for a child:

44. o Mag. Sulfate 4 gms IV ordered –
16 gms delivered
ImagecopyrightPharmCon,Inc.
Not Just Children

45. oBeyond human capability?
We have a Problem

46. o EMRs document intentions
An Unseen Problem

47. oEvery calculation is an
opportunity for error
Look familiar?

48. Look familiar?
oEvery calculation is an
opportunity for error

49. Error rate
Under normal conditions 3%
Under stress 25%
People Make Mistakes

50. oWants just-in-time
knowledge within
the clinical workflow
The Adult
Learner

51. “Two Standards?”
The Answer has to be technology!

52. Two
Standards?

53. Day
Night?

54. o Avoids selection errors
o Prevents concentration
misreads
and calculation mistakes
High Reliability
Preparation:
Scanning the Vial

55. Turning the “NDC Code” into a “knowledge code”
The unique role of “assistive technologies” in pediatric med safety
1) Verifies Dose
2) Checks warnings
3) Administration guidelines
4) Y site compatibilites
5) Adverse side effects
6) Patient counseling

56. Using Children’s Hospital’s own References
o 17% of 130 prepared meds had errors
o 7% clinically significant errors
o Dose error range: 50% to 900%
—J Pediatr Pharmacol Ther
2014;19(3):174–181
Does it work?

57. Simulation Study: Using eBroselow
o 0 clinically significant dosing errors
o 0 pharmacy consults needed
o Reduced time to prepare meds -
including less experienced nurses
10 minutes training - 13 nurses - 130 med
orders
Evidence-based
—J Pediatr Pharmacol Ther
2014;19(3):174–181

58. When lives are
on the line, we
do math

59. When money is
on the line, we
barcode!

60. Q & A
We encourage your participation

61. Thank you!
Join us for our next quarterly webinar on
Airway Safety
June 14, 2017