Barcode Medication Administration System Studies in a NICU April 24, 29 Frank H. Morriss, Jr. MD, MPH Division of Neonatology Department of Pediatrics Carver College of Medicine University of Iowa Iowa City, Iowa I have nothing to disclose Questions Does your hospital employ a barcode medication administration (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? 1
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 Background Why Medication Errors Occur Many opportunities for error NICU Care - A Complex Adaptive System Morriss FH. NeoReviews 28; 9:e8-23 2
Background Why Medication Errors Occur Many opportunities + Limitations of human for 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 on Unit Dose Barcode Scan Provider Pharmacy Patient/Nurse Background CPOE Barcode on Unit Dose Barcode Scan Proven effective in decreasing ADEs in pediatrics 3
Effectiveness of CPOE in Reducing ADEs on a Pediatric Inpatient Service 1 94 9 8 7 6 5 4 3 46 26 35 no cpoe cpoe N = 1197 pts N = 121 pts 2 1 pade Preventable ADEs Potential ADEs serious me Holdsworth MT et al. Pediatrics 12:158, 27. Background CPOE Barcode on Unit Dose Barcode Scan Proven effective in decreasing ADEs in pediatrics } Not yet proven effective in decreasing ADEs in any population Aims Primary: 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 4
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 the risk of ADEs. *Cerner Bridge Medication Administration system, v 3.4, Cerner Corporation, Kansas City, MO. Study Design Prospective observational study 36-bed NICU 3 Phases: No BCMA; 5% BCMA; 1% 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 O 2 ), 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 medication error Non-targeted ADE: ADEs that are not expected to be impacted by BCMA system. Ex: Infiltration, TPNcholestasis Targeted, preventable ADE: all others 5
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 5 total weeks Phase 1 19 continuous weeks - NO BCMA Phase 2 12 weeks (9 + 3) - 5% BCMA Phase 3 19 continuous weeks - 1% BCMA To detect learning effect Results: Characteristics of Subjects, means: Phase 1 2 3 BCMA - - + + Subjects 328 149 131 352 Subject-d 4,534 1,56 1,446 4,78 *BWt, kg 2.462 2.258 2.25 2.41 GA, wk 34.7 34. 33.8 34.6 Male, % 58.8 63.3 57.3 6.5 *Twin, % 8.8 15. 12.2 16.2 *Triplet, %.9 6.1 3.1 2.6 *Cauc n, % 79.9 81.6 81.7 85.8 *p<.5 6
Results: Characteristics of Subjects, means, con t: Phase 1 2 3 BCMA - - + + *Nursing hrs/ subject/ d, mean 1.6 1.2 1.6 1.4 Doses/ subject/ d, mean 7.5 8. 7.8 7.4 *p<.5 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. 29;154:363-8. Effect of BCMA System in NICU: GEE Model for Rate of Targeted Preventable ADE Predictor RR (95% CI) p BCMA system.53 (.29,.91).4 log 1 doses/subj/d 1.48 (3.93, 27.92) <.1 BWt in kg 1.25 (.97, 1.62).8 Caucasian 1.36 (.65, 2.82).42 Twin 1.18 (.4, 3.44).76 Triplet 2.45 (.68, 9.8).17 Nursing hrs/ subject/d 1.12 (.81, 1.561).48 Morriss FH, et al. J Pediatr. 29;154:363-8. 7
Examples of preventable ADEs 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 2 min before extubation. Post-extubation, apnea occurred, rx d with diuretic and CPAP. Next morphine dose associated with recurrence of apnea. Classes of MEs Related to Targeted Preventable ADEs in Phase 3 (BCMA System 1% Operative) ME Class ME, n Alerts, n Overridden, n Wrong time 8 Reconciliation 2 Omitted dose 1 Wrong dose ordered 1 Transcription 1 Other * 5 Total 18 3 *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 8
Characteristics of Subjects by Status Subjects with Subjects with no post-op post-op period period (n = 54) (n = 78) p GA, wk, mean (SD) 35.2 (4.4) 33.9 (5.7).22 Birth wt, kg, mean (SD) 2.543 (1.78) 2.29 (1.187).57 Male, n (%) 322 (59.6) 51 (65.4).331 Mult birth, n (%) 83 (15.4) 5 (6.4).37 BCMA in use, n (%) 284 (52.6) 38 (48.7).52 LOS in unit, d, median (IQR) 7 (3, 14) 1.5 (6, 19) <.1 Cum doses before ADE or censoring n, median (IQR) 3 (11, 67) 64.5 (29, 147) <.1 1 st prev ADE, n (%) 24 (4.4) 8 (1.3).3 1 st pot l ADE, n (%) 183 (33.9) 35 (44.9).58 Increased Risk of Preventable ADE for Postoperative NICU Patients Not Postoperative Postoperative 2 3 Adjusted survival distribution curves determined by Cox proportional hazards method, by postoperative status, plotting the 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 ADEs in Post-op Patients Medications MSO4 ± lorazepam (3) Inadequate pain control 2/3 Antibiotics (3) Inhaled bronchodilator (1) Bolus IV fluid (1) Classes of ME Before 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) 9
Analysis of MEs Associated with ADEs in Post-op Patients Timing of events in the hospital course of post-op ADE patients Birth Admit to Op ADE study unit procedure 5.5 (, 22.5) 22 (7, 57) days age days age 5.5 (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 Timeline: Nurses Survey Re BCMA System 1/5 4/6 12/6 6-7/8 Studies BCMA Studies Nurses Begin Starts End Survey Study Conducted Survey: 3-Items; Web; IRB; Voluntary; Anonymous Survey Response: 46/14 Bay 2/3 staff = 44.2% Respondents: Median age: 26-3 yr; but 14 (3%) >4 yr Included 7% who had worked in NICU before 4/6 1
Time Required to Feel Comfortable with BCMA System 5 45 44 4 35 3 25 2 18 22 15 1 7 7 5 2 Less than 1 Week 1-2 Weeks 3-4 Weeks 5-6 Weeks More than 6 Weeks Not Yet Nurses' Opinions of BCMA System 1 9 8 7 6 5 4 89 84 3 58 2 36 1 9 BCMA Prevented ME BCMA Avoided ADE Aware of ADEs with BCMA BCMA Improved Safety BCMA Has Not Improved Safety Effect of BCMA System on Time Required for Medication Administration (n= 32) 6 5 Per cent 4 3 2 56 1 9 13 22 Somewhat Less About Same Somewhat More Much More 11
Opinion re Alert Frequency 8 6 4 2 2 72 24 Never <25% ~ 25% ~ 5% 33% actual during study 2 Opinion re Alert Effectiveness 5 4 3 2 1 2 44 41 Observed effectiveness: 66% decrease MEs (nonwrong time) Not 1 Some- 2 Usually 3 Almost 4 Always 5 what Always 9 4 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%) 12
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. 22;9:54-53. Effect of BCMA System on Nurse Distraction from Other Patient Cares 6 5 4 3 2 1 51 27 18 4 Never Ocasionally Often Always Not Sure The Nursing Stress Scale* Stress 1 Items selected; responses assigned a score, scores summed Mean (SD) score for all: 11.8 (5.2) (lowmoderate stress) Mean score for > 3 years in NICU: 13.5 Mean score for < 3 years in NICU: 1.1 (p=.4) *Gray-Toft P, Anderson JG. The Nursing Stress Scale: Development of an instrument. J Behav Assess. 1981;3:11-23. 13
Fear of Making a Mistake in Treating Patient 7 6 5 Per cent 4 3 59 2 1 9 18 11 Never Occasionally Frequently Extremely Uncertainty re Operation of Specialized Equipment 7 6 5 4 3 58 2 1 5 28 9 Never Occasionally Frequently Extremely Feeling Inadequately Trained 1 9 8 7 6 5 4 3 57 2 1 23 7 9 Never Occasionally Frequently Extremely 14
Breakdown of Computer 4 35 3 25 2 15 3 36 34 1 5 Never Occasionally Frequently Extremely Shortcut to barcode scanning.jpg.lnk P e r C e n t 6 5 4 3 2 1 Opinion re Ergonomics How would you describe your interaction with the hardware? N= 32 6 31 56 6 6 Awkward 1 Somewhat 2 3 4 Awkward P e r C e n t 5 4 3 2 1 4 16 1 2 Neutral 3 User Friendly 4 36 44 Initially wall-mounted Later placed on counter 15
Unintentional Effects Increased catheter-related problems (p>.5) raised question of nursing distraction or revised priority Some nurses not happy campers Computer breakdowns even more stressful Workarounds Workarounds Are you aware of workarounds? 5 45 4 35 3 25 2 15 1 5 44 11 44 Yes 1 No 2 Don't Know 3 Possible causes: Faulty equipment Barcodes that will not scan Med administration schedule control by pharmacist Inadequate list of options for administering med differently from order Effect of BCMA System on Nursing Professionalism 8 7 6 5 4 3 2 1 69 28 3 Decreases No Effect Increases 16
Effect of BCMA System on Job Satisfaction 6 5 4 3 2 51 36 1 Good Neutral Bad 13 Strong UICH Support for Innovation How 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 17
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 References Gray-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 28; 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 29;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. 22;9:54-53. Acknowledgements Co-investigators At U of Iowa: Paul Abramowitz Steven Nelson Gary Milavetz Stacy Michael Sara Gordon Jane Pendergast Anne Wallis Lee Carmen At HSPH and BWH: E. Francis Cook Support American Society of Health-System Pharmacists R&E Foundation UI Pharmaceutical Enterprise UI Department of Pediatrics 18
Barcode Medication Administration System Studies in a NICU ACPE UAN: 121--9-9-L5-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