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

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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

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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__