1
Barcode Medication Administration System Studies in a NICU
April 24, 2009
Frank H. Morriss, Jr. MD, MPH
Division of Neonatology Department of Pediatrics
Carver College of MedicineUniversity of Iowa
Iowa City, Iowa
I have nothing to disclose
Questions• Does your hospital employ a barcode medicationadministration (BCMA) system?
• Do you know that it reduces harm to patients from medication errors?
• Are there any downsides to BCMA use?
• Do you know of certain patients who are more at risk to sustain an adverse drug event and when?
• What do the end-users of a BCMA system think about it?
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Outline of Presentation
Review why medication errors (MEs) occur,especially in a NICU
Describe 3 BCMA studies conducted in a NICU:• BCMA effectiveness in preventing adverse drug
events (ADEs)
• Identification of NICU patients at high risk of ADE
• Nurse survey about acceptance of BCMA and opinions
BackgroundWhy Medication Errors Occur
Many opportunitiesfor error
NICU Care - A Complex Adaptive System
Morriss FH. NeoReviews 2008; 9:e8-23
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BackgroundWhy Medication Errors Occur
Many opportunities + Limitations of humanfor error phenotype
+Defenses fail
=
Humanly unavoidable errors
Background
• Medication errors may lead to preventable adverse drug events i.e., harm
• Institute of Medicine recommends three linked IT systems to prevent MEs and ADEs
CPOE Barcode onUnit Dose
Barcode Scan
Provider Pharmacy Patient/Nurse
Background
CPOE Barcode onUnit Dose
Barcode Scan
Proven effective in decreasing
ADEsin pediatrics
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Effectiveness of CPOE in Reducing ADEson a Pediatric Inpatient Service
46
26
94
35
0
10
20
30
40
50
60
70
80
90
100
pade serious me
no cpoecpoe
Holdsworth MT et al. Pediatrics 120:1058, 2007.
N = 1197 ptsN = 1210 pts
Preventable PotentialADEs ADEs
Background
CPOE Barcode onUnit Dose
Barcode Scan
Proven effective in decreasing
ADEsin pediatrics
Not yet proven effective in decreasing ADEs
in any population
}
AimsPrimary:• To test effectiveness of a Barcode Medication
Administration (BCMA) system in reducing harmful events in the NICU i.e., preventable ADEs
Secondary:• Characterize MEs, potential ADEs, preventable ADEs
in NICU– Nature of injuries– Risk factors (predictors)– Rate- unadjusted, adjusted – Timing- days in unit, day of week, shift, holidays, etc– Classes of ME– Drugs involved– Multiple events in same pt
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Hypothesis for Primary Aim
A barcode medication administration (BCMA) system* will decrease the risk of targeted preventable ADEs by 45% or more in a NICU, controlling for variables that contribute to therisk of ADEs.
*Cerner Bridge Medication Administration system, v 3.4, CernerCorporation, Kansas City, MO.
Study Design
• Prospective observational study• 36-bed NICU• 3 Phases: No BCMA; 50% BCMA; 100% BCMA• Daily structured audit of medical records to
detect ME, serious ME and pADE• Data collected includes:
– Doses administered/subject/day– Nursing hours/subject/day– Surgery prior to ADE– Ventilated or not
Study Design, continued• Definitions
– Medication: any ordered drug (except O2), i.v. fluid, or blood product by any route
– ME: error in ordering, transcribing, dispensing, administration or monitoring a medication
– Potential ADE: a serious ME, one that has the potential to harm, but either was intercepted or reached the patient but failed to harm
– Preventable ADE: harm caused by a medicationerror
– Non-targeted ADE: ADEs that are not expected to be impacted by BCMA system. Ex: Infiltration, TPN-cholestasis
– Targeted, preventable ADE: all others
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Study Design, continued
• Each ME was classified by an expanded Allan and Barker classification
• Blinded assignment of events as: potential ADE or ADE
• Preventable ADEs sorted into targeted, preventable ADE or non-targeted, preventable ADE
Results
• 958 NICU subjects
• 92,398 doses administered
• 50 total weeksPhase 1 19 continuous weeks - NO BCMAPhase 2 † 12 weeks (9 + 3) - 50% BCMA Phase 3 19 continuous weeks - 100% BCMA
† To detect learning effect
Results: Characteristics of Subjects, means:
Phase 1 2 3BCMA - - + +
Subjects 328 149 131 352Subject-d 4,534 1,560 1,446 4,708*BWt, kg 2.462 2.258 2.205 2.410GA, wk 34.7 34.0 33.8 34.6Male, % 58.8 63.3 57.3 60.5*Twin, % 8.8 15.0 12.2 16.2*Triplet, % 0.9 6.1 3.1 2.6*Cauc’n, % 79.9 81.6 81.7 85.8*p<0.05
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Results: Characteristics of Subjects, means, con’t:
Phase 1 2 3BCMA - - + +
*Nursinghrs/subject/d, mean 10.6 10.2 10.6 10.4
Doses/subject/d, mean 7.5 8.0 7.8 7.4*p<0.05
Results
• 47% reduction in targeted preventable ADEs, adjusted for other predictors, most importantly,
– number of medication administrations/patient/day
Morriss FH, et al. J Pediatr. 2009;154:363-8.
Effect of BCMA System in NICU: GEE Model for Rate of Targeted Preventable ADE
Predictor RR (95% CI) p
BCMA system 0.53 (0.29, 0.91) 0.04log10 doses/subj/d 10.48 (3.93, 27.92) <0.001BWt in kg 1.25 (0.97, 1.62) 0.08Caucasian 1.36 (0.65, 2.82) 0.42Twin 1.18 (0.40, 3.44) 0.76Triplet 2.45 (0.68, 9.08) 0.17Nursing hrs/
subject/d 1.12 (0.81, 1.561) 0.48
Morriss FH, et al. J Pediatr. 2009;154:363-8.
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• Late or missed dose of scheduled inhaled bronchodilators and corticosteroids in pt with severe CLD and pulmonary hypertension (rx iNO, sildenafil), who subsequently exhibited worsening respiratory status and had to be rescued emergently.
• NPO term infant, on IV fluids. Correct fluid ordered, but actual infusion rate significantly less than ordered for 5 hours. Infant became symptomatically hypoglycemic.
• Premie with CLD nearing discharge, made NPO for hernia repair. Oral diuretics not re-written for IV route; had surgery. Post-op morphine @ appropriate dose given 20 min before extubation. Post-extubation, apnea occurred, rx’d with diuretic and CPAP. Next morphine dose associated with recurrence of apnea.
Examples of preventable ADEs
Classes of MEs Related to Targeted Preventable ADEs in Phase 3 (BCMA System 100% Operative)
ME Class ME, n Alerts, n Overridden, nWrong time 8Reconciliation 2Omitted dose 1Wrong dose ordered 1Transcription 1Other * 5Total 18 3 0
*Prescriber judgment or omission
Results
• Effectiveness in reducing adverse drug events (ADEs)• 47% reduction, adjusted for other predictors, most
importantly, number of med administrations/patient/day
• Identify especially vulnerable NICU patients (only phases 1 & 3 subjects)
• Postoperative patients have a 2.5-fold increased risk, adjusted for predictors– BCMA system reduced the increased risk in this
group
• Assisted ventilation patients not at greater risk in separate survival analysis
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Characteristics of Subjects by Status
Subjects with Subjects withno post-op post-opperiod period(n = 540) (n = 78) p
GA, wk, mean (SD) 35.2 (4.4) 33.9 (5.7) 0.022Birth wt, kg, mean (SD) 2.543 (1.078) 2.290 (1.187) 0.057Male, n (%) 322 (59.6) 51 (65.4) 0.331Mult birth, n (%) 83 (15.4) 5 (6.4) 0.037BCMA in use, n (%) 284 (52.6) 38 (48.7) 0.520LOS in unit, d,
median (IQR) 7 (3, 14)† 10.5 (6, 19) <0.001Cum doses before
ADE or censoringn, median (IQR) 30 (11, 67) 64.5 (29, 147) <0.001
1st prev ADE, n (%) 24 (4.4) 8 (10.3) 0.0301st pot’l ADE, n (%) 183 (33.9) 35 (44.9) 0.058
Increased Risk of Preventable ADE for Postoperative NICU Patients
Postoperative
Not Postoperative
20 30
Adjusted survival distribution curves determined by Cox proportional hazards method, by postoperative status, plottingthe probability that a subject remains free of a first preventable adverse drug event in the NICU (y axis) longer than a specified time after admission (x-axis). At 59 days there remained 9 uncensored subjects in the group with no postoperative period and 2 in the postoperative group.
Analysis of MEs Associated with ADEsin Post-op Patients
MedicationsMSO4 ± lorazepam (3)– Inadequate pain control 2/3
Antibiotics (3)Inhaled bronchodilator (1)Bolus IV fluid (1)
Classes of MEBefore BCMA:
Omitted dose (2)Wrong time (2)Wrong dose ordered (1)Wrong dose given (1)Wrong rate of administration (1)
After BCMA:Clinically inadequate dose of MSO4 for pain control (1)
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Analysis of MEs Associated with ADEsin Post-op Patients
Timing of events in the hospital course of post-op ADE patients
Birth Admit to Op ADEstudy unit procedure5.5 (0, 22.5) 22 (7, 57)
days age days age5.5 (1, 8)
Barcode Medication Administration (BCMA) System Studies in UIHC NICU
• Effectiveness in reducing adverse drug events (ADEs)• 47% reduction, adjusted for other predictors,
most importantly, number of med administrations/patient/day
• Identify especially vulnerable NICU patients• Postoperative patients have a 2.5-fold increased
risk, adjusted for predictors• BCMA system reduced the increased risk in this
group• Survey of NICU nurses re experience, opinions,
thoughts about the BCMA system
Nurses Survey Re BCMA SystemTimeline:
10/05 4/06 12/06 6-7/08Studies BCMA Studies Nurses’Begin Starts End Survey Study
Conducted
Survey:30-Items; Web; IRB; Voluntary; Anonymous
Survey Response:46/104 Bay 2/3 staff = 44.2%
Respondents: Median age: 26-30 yr; but 14 (30%) >40 yrIncluded 70% who had worked in NICU before 4/06
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Time Required to Feel Comfortable with BCMA System
18
44
22
7
2
7
0
5
10
15
20
25
30
35
40
45
50
Less than1 Week
1-2Weeks
3-4Weeks
5-6Weeks
More than6 Weeks
Not Yet
Per
Cen
t
Nurses' Opinions of BCMA System
89
5836
84
90
10
20
30
40
50
60
70
80
90
100
BCMAPrevented
ME
BCMAAvoided
ADE
Aware ofADEs with
BCMA
BCMAImproved
Safety
BCMA HasNot
ImprovedSafety
Per
Cen
t
Effect of BCMA System on Time Required for Medication Administration (n= 32)
9 13
56
22
0
10
20
30
40
50
60
SomewhatLess
About Same SomewhatMore
Much More
Per c
ent
12
Opinion re Alert Frequency
2
72
2420
20
40
60
80
Never <25% ~ 25% ~ 50%
Per C
ent
33% actual during study
Opinion re Alert Effectiveness
2
44 41
9 40
10
20
30
40
50
1 2 3 4 5
Per C
ent
Not Some- Usually Almost Alwayswhat Always
Observed effectiveness:
66% decrease MEs (non-wrong time)
Choices to Improve Alerts
Improve Effectiveness:• Reduce alerts to the most effective ones (33%)• Different colors for various alert types (24%)• Additional alerts (22%)• Widen window of wrong-time alert (17%)
Improve Nurse-friendliness:• Widen window of wrong-time alert (44%)• Reduce alerts to the most effective (41%)• Eliminate the wrong-time alert (17%)• Use different colors for various alerts (17%)
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5 Negative Side Effects Observed by Patterson after BCMA Implementation
• Increased prioritization of monitored activities during goal conflicts
• Nurses dropping activities to reduce workload during busy periods
• Nurses confused by automated removal of medications after BCMA implementation
• Degraded coordination between nurses and physicians
• Decreased ability to deviate from routine sequences
Patterson ES et al. Improving patient safety by identifying side effects from introducing bar coding in medication administration. J Am Med Inform Assoc. 2002;9:540-53.
Effect of BCMA System on Nurse Distraction from Other Patient Cares
27
51
18
0 40
10
20
30
40
50
60
Never Ocasionally Often Always Not Sure
Per C
ent
StressThe Nursing Stress Scale*
• 10 Items selected; responses assigned a score, scores summed
• Mean (SD) score for all: 11.8 (5.2) (low-moderatestress)
• Mean score for > 3 years in NICU: 13.5
• Mean score for < 3 years in NICU: 10.1 (p=0.04)
*Gray-Toft P, Anderson JG. The Nursing Stress Scale: Development of an instrument. J Behav Assess. 1981;3:11-23.
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Fear of Making a Mistake in Treating Patient
9
59
1811
0
10
20
30
40
50
60
70
Never Stressful OccasionallyStressful
FrequentlyStressful
ExtremelyStressful
Per c
ent
Uncertainty re Operation of Specialized Equipment
5
58
28
90
10
20
30
40
50
60
70
NeverStressful
OccasionallyStressful
FrequentlyStressful
ExtremelyStressful
Per C
ent
Feeling Inadequately Trained
23
57
7 90
10
20
30
40
50
60
70
80
90
100
NeverStressful
OccasionallyStressful
FrequentlyStressful
ExtremelyStressful
Per C
ent
15
Breakdown of Computer
0
3036 34
0
5
10
15
20
25
30
35
40
NeverStressful
OccasionallyStressful
FrequentlyStressful
ExtremelyStressful
Per C
ent
Shortcut to barcode scanning.JPG.lnk
Opinion re ErgonomicsHow would you describe your interaction with the hardware?
31
56
6 60
10
20
30
40
50
60
1 2 3 4 Awkward Somewhat Awkward
PerC
ent
Initially wall-mounted Later placed on counter
416
3644
0
10
20
30
40
50
60
1 2 3 4Neutral User Friendly
Per
Cent
N= 32
16
Unintentional Effects
• Increased catheter-related problems (p>0.05) raisedquestion of nursing distraction or revised priority
• Some nurses not happy campers
• Computer breakdowns even more stressful
• Workarounds
WorkaroundsAre you aware of workarounds?
Possible causes:• Faulty equipment• Barcodes that will not
scan• Med administration
schedule control bypharmacist
• Inadequate list of options for administering meddifferently from order
44
11
44
05
101520253035404550
1 2 3 Yes No Don't Know
Per C
ent
Effect of BCMA System on Nursing Professionalism
3
28
69
0
10
20
30
40
50
60
70
80
Decreases No Effect Increases
Per C
ent
17
Effect of BCMA System on Job Satisfaction
36
13
51
0
10
20
30
40
50
60
Good Neutral Bad
Per C
ent
Strong UICH Support for InnovationHow supportive of innovation and openness to change are each of the groups?
Take Home Points• BCMA system is effective
• The number of administrations/day/patient is a major exposure risk for harm
• Postoperative neonates may have a greater risk of an adverse drug event
• Enthusiastic acceptance of BCMA system by most has occurred 1.5-2 yr after installation
• Learning curve
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Take Home Points• Ergonomics are important
• Breakdown of a computer is stressful
• Unintentional effects
• Areas for improvement
• These results should be generalized with caution to other settings
ReferencesGray-Toft P, Anderson JG. The Nursing Stress Scale: Development of an instrument.” J Behav Assess 1981;3:11-23.
Morriss FH. Adverse medical events in the NICU: Epidemiology and prevention. NeoReviews 2008; 9:e8-23.
Morriss FH, Abramowitz PW, Nelson SP, Milavetz G, Michael SL, Gordon SN, et al. Effectiveness of a barcode medication administration system in reducing preventable adverse drug events in a neonatal intensive care unit: a prospective cohort study. J Pediatr 2009;154:363-8.
Patterson ES, Cook RI, Render ML. Improving patient safety by identifying side effects from introducing bar coding in medication administration. J Am Med Inform Assoc. 2002;9:540-53.
AcknowledgementsCo-investigators Support
At U of Iowa: American Society of Paul Abramowitz Health-System Steven Nelson Pharmacists R&E Gary Milavetz Foundation Stacy Michael Sara Gordon UI Pharmaceutical Jane Pendergast EnterpriseAnne WallisLee Carmen UI Department of
Pediatrics At HSPH and BWH:E. Francis Cook
Barcode Medication Administration System Studies in a NICU ACPE UAN: 121-000-09-009-L05-P The following are 5 questions for self-assessment: 1. Which of the following NICU characteristics contribute(s) to the relatively high rates of medication error and preventable adverse drug event ? (Check all that apply) A. NICUs are complex adaptive systems B. NICUs have “tight coupling”, i.e., not much slack in their operation C. The human phenotype has limitations in capacity to remember and to execute tasks D. Defenses that we employ against error fail E. All of the above 2. Both computer provider order entry (CPOE) and barcode medication administration (BCMA) systems can reduce preventable adverse drug events on pediatric/neonatal inpatient services. True or False? True__ False__ 3. The more medication administrations that a patient receives in a day, the more likely is s/he to sustain a preventable adverse drug event. True or False? True__ False__ 4. Nurses who work in a hospital equipped with a barcode medication administration (BCMA) system (Check all that apply):
A. May give the BCMA activities priority over other nursing tasks because the BCMA system leaves a trail, i.e., is monitored.
B. Generally are stressed when the computer is “down” C. Engage in “workarounds” to circumvent a function of the system when it
generates certain alerts or a barcode will not scan. D. Are skeptical about the effectiveness of the system and believe that it erodes
professionalism and job satisfaction. E. All of the above 5. Certain patients may be at greater risk of an adverse drug event than others, adjusted for the number of medication administrations they receive and the presence of a barcode medication administration system. True or false? True__ False__