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1 Online Exhibit: Published Research on EMR-Related Errors, Authors: McDonald CJ (2006) Journal: Annals of Internal Medicine Design: Case study Findings: Bar-coded identification wristband mistakenly placed on wrong patient resulting in near miss. Human vigilance may be weakened by computer systems. Conclusions: Computer systems may cause new errors without cross-check processes in place. Authors: Cochran GL, Jones KJ, Brockman J, Skinner A, Hicks RW (2007) Journal: The Joint Commission Journal on Quality and Patient Safety Design: Descriptive study on effectiveness of BCMA in preventing and inducing medication errors Findings: Out of 515 reported errors from January 1, 2000, to December 31, 2005, 445 errors reported were a consequence of BCMA. 284 (64%) were either opportunities for error or actual errors that were intercepted by staff before reaching the patient; 160 (36%) reached the patient but did not cause harm. No BCMA-related errors caused prolonged hospitalizations, permanent harm, or death. One-third (146) could not be associated with a specific phase of the medication administration process. Almost three-quarters involved medications without bar codes or bar codes that could not be read by the machine (n=108). Conclusions: Adopting BCMA technology does not eliminate medication errors. The availability of manufacturer bar codes on unit-dose medications could eliminate the majority of reported errors described in this report. Authors: Koppel R, Wetterneck T, Telles JL, Karsh BT (2008) Design: Descriptive study using observation and shadowing of nurses, interviews of staff and leaders, participation in BCMA meetings and failure mode and effects analysis (FMEA), and analysis of BCMA override log data Findings: Identified 15 types of workarounds such as affixing patient identification bar codes to computer carts, scanners, doorjambs, or nurses belt rings and carrying several patients pre-scanned medications on carts. Identified 31 causes of workarounds, such as unreadable medication bar codes; unreadable or missing patient identification wristbands; nonbarcoded medications; battery failures; uncertain wireless connectivity; emergencies. BCMA alerts were overridden for 4.2% of patients charted and for 10.3% of medications charted. Conclusions: Shortcomings in design, implementation, and work flow integration encourage workarounds that may result in administration of wrong medications, wrong doses, wrong times, and wrong formulations. Authors: Goldstein MK, Hoffman BB, Coleman RW, Tu SW, Shankar RD, O Connor M, Martins S, Advani A, Musen MA (2001) Journal: AMIA Annual Symposium Proceedings 1

2 Journal of Healthcare Management 56: 1 January/ February 2011 Design: Case study Findings: Potential sources of error include medication withdrawal, missing data leading to recommendation of a contraindicated drug, potential interaction of the recommended drug with another prescribed drug, inaccuracies in program inputs or logic leading to erroneous recommendations, rearranging clinician priorities with required used of CDSS, false expectations that alerts will generate for all problems, data overload, and incorrect recommendations. Conclusions: CDSS guidelines should be assessed for safety features. Potential sources of harm or error should be anticipated and addressed. Authors: Tsai TL, Fridsma DB, Gatti G (2003) Design: Randomized controlled trial to determine the effect that the computer interpretation (CI) of EKGs had on accuracy of noncardiology residents and physicians Findings: Subjects were 48.9% accurate without CI; 55.4% accurate with CI. When correct CI was not included accurate interpretation was 53.1%. When correct CIs were included, accurate interpretation increased to 68.1%. Subjects erroneously agreed with incorrect CI more often when it was presented with the EKG (67.7%) than when it was not (34.6%). Conclusions: End users are influenced significantly by incorrect advice which decreases usefulness. Authors: Eslami S, Abu-Hanna A, de Keizer NF, de Jonge E (2006) Journal: Drug Safety Design: Retrospective comparison of gentamycin and tobramycin CPOE prescriptions with locally developed guideline Findings: 392 prescriptions were analyzed in a total of 253 patients, 184 with renal insufficiency. 58% used the CPOE default dose which was incorrect in 73% of the cases. Conclusions: Initial CPOE dose value for gentamycin and tobramycin based on a default value are a potential source for adverse drug events in patients with renal insufficiency. Authors: Van der Sijs H, Lammers L, van den Tweel A, Aarts J, Berg M, Vulto A, Van Gelder T (2009) Design: Interventional study to reduce drug administration errors due to overridden timedependent drug drug interaction (TDDI) alerts Findings: The first study showed significant drug administration error reduction from 56.4% to 36.2% (p < 0.05), whereas the second study was not successful (46.7% and 45.2%; p > 0.05). Despite interventions, drug administration errors still occurred in more than one-third of cases and prescribing errors in 79% to 87% of cases. Incorrectly prescribed combinations (79% 98%) because of erroneous TDDI alert overriding were an important cause of administration errors. Conclusions: Alert fatigue along with low alert specificity, unclear alert information content, 2

3 Published Research on EMR- Related Errors, and the inability of the software to support safe and efficient TDDI alert handling all diminished correct prescribing, and consequently, insufficiently reduced drug administration errors. Authors: Cheng CH, Goldstein MK, Geller E, Levitt RE (2003) Journal: AMIA Annual Symposium Proceedings Design: Observational study of CPOE work flow in an intensive care unit after implementation of CPOE Findings: CPOE created coordination redundancy through increasing the coordination loads among clinicians and adding new verification tasks. Minor inconveniences with the computational interface resulted in adaptations to circumvent the desired safety features of the system. Conclusions: Execution of physician orders is not a linear process. Policies designed to increase flexibility and safety led to an increased coordination load on the healthcare team and created opportunities for new sources of error. Authors: Dykstra R (2003) Journal: AMIA Annual Symposium Proceedings Design: Secondary data analysis of a qualitative study using participant observations, focus groups, and oral histories to examine the impact of CPOE on communication and how that affects implementation Findings: Significant and unanticipated effects occurred on communication channels and relationships (physician and nurses, pharmacy and patients). For example, the new process of physicians entering orders from any location reduced interpersonal contact with bedside clinicians adversely affecting team relationships and cohesion. Conclusions: Robust bi-directional information channels potentially mission-critical. Authors: King WJ, Paice N, Rangrej J, Forestell GJ, Swartz R (2003) Journal: Pediatrics Design: Retrospective cohort study comparing 2 medical wards with CPOE and 1 medical ward and 2 surgical wards using hand-written orders Findings: Over a period of six years, a total of 804 medication errors were identified including 18 adverse drug events resulting in patient injury. Medication error rate (MER) was 4.49 per 1,000 patient days. Before CPOE, MERs in the experimental and control groups were indistinguishable. After CPOE, MERs were 40% lower in CPOE experimental group than in control group. There was not a similar effect on adverse drug events (ADEs). Conclusions: CPOE was associated with a significant decrease in MERs but not ADEs in an inpatient pediatric population. Authors: Han YY, Carcillo JA, Venkataraman ST, Clark RSB, Watson RS, Nguyen TC, Bayir H, Orr RA (2005) Journal: Pediatrics 3

4 Journal of Healthcare Management 56: 1 January/ February 2011 Design: Retrospective regression analysis of factors associated with mortality in 1394 admissions before CPOE and 548 admissions after CPOE, both adjusted for PRISM (Pediatric Risk of Mortality) score Findings: Univariate analysis showed mortality rate significantly increased from 2.8% (39 of 1394) before CPOE to 6.57% (36 of 548) after CPOE. Multivariate analysis revealed CPOE remained independently associated with increased odds of mortality after adjustment for other mortality covariables. Conclusions: When implementing CPOE, institutions should continue to evaluate mortality effects, in addition to medication error rates, for children dependent on time-sensitive therapies. Authors: Koppel R, Metlay JP, Cohen A, Abalock B, Localio AR, Kimmel SE, Strom BL (2005) Journal: JAMA Design: Qualitative and quantitative study of house staff interaction with CPOE using survey, focus groups, one-on-one interviews, and shadowing and observation Findings: Widely used CPOE system facilitated 22 types of medication error risks. Multiple qualitative methods identified and quantified error risks not previously considered, offering opportunities for error reduction. Conclusions: As CPOE systems are implemented, clinicians and hospitals must attend to errors caused by CPOE in addition to those they prevent. Authors: Nebeker JR, Hoffman JM, Weir CR, Bennett CL, Hurdle JF (2005) Journal: Archives of Internal Medicine Design: Prospective randomized case reviews of EMR for a 20-week period. One of two pharmacists classified ADEs according to predetermined criteria followed by consensus with two physicians, a nurse researcher, and the project coordinator. Findings: From 937 hospital admissions, 483 clinically significant ADEs were identified. This equates to 52 ADEs per 100 admissions and an incident density of 70 ADEs per 1,000 patient days. One-fourth of the hospitalizations had at least one ADE. 9% of all ADEs resulted in serious harm. ADEs resulted from ordering (61%), monitoring (25%), administration (13%), and dispensing (1%). Conclusions: High rates of ADEs may continue to occur following CPOE implementation and related computerized medication systems that lack CDSS for drug selection, dosing, and monitoring. Authors: Shulman R, Singer M, Goldstone J, Bellingan G (2005) Journal: Critical Care Design: Before and after comparison of hand-written prescribing (HWP) and CPOE without decision support. Sampling occurred 28 weeks before implementation of CPOE and 2, 10, 25, and 37 weeks after. Findings: Medication errors with CPOE were significantly less (4.8%) than with HWP (6.7%) (p < 0.04). Two errors with CPOE resulted in patient harm. Differences were noted in the types of errors between CPOE and HWP. 4

5 Published Research on EMR- Related Errors, Conclusions: CPOE was associated with a reduction in the proportion of medication errors. Moderate and significant errors remained a significant concern following implementation of CPOE. The introduction of CPOE without decision support eliminated many minor types of error but introduced new types of errors that may be more serious. Authors: Spencer DC, Leininger A, Daniels R, Granko RP, Coeytaux RR (2005) Journal: American Journal of Health-System Pharmacists Design: Retrospective review of reported medication errors before and after implementation of CPOE Findings: Implementation of CPOE was associated with a significant increase in reported errors, from to per discharge (p = ). Conclusions: CPOE implementation at an academic health center was associated with a significant increase in voluntarily reported medication errors related to problems in pharmacy processing of medication orders. Authors: Thompson DA, Duling L, Holzmueller CG, Dorman T, Lubomski LH, Dickman F, Fahey M, Morlock LL, Wu AW, Pronovost PJ (2005) Journal: Journal of Clinical Outcomes Management Design: Descriptive study using the ICUSRS database Findings: Found 55 incidents, majority (85%) resulted in medication errors, 37 (65%) of these were coded as user errors, 11 (20%) as software errors, and 7 (13%) as computer malfunctions. Conclusions: CPOE software is reported as source of errors. Authors: Campbell EM, Sittig DF, Ash, JS, Guappone KP, Dykstra RH (2006) Design: Qualitative design whereby six research team members met 36 times to analyze data using a card sort method focusing solely on consequences requiring prevention or remedial action Findings: Unintended adverse consequences (UACs) fell into 9 major categories (in order of decreasing frequency): 1) more/new work for clinicians; 2) unfavorable work flow issues; 3) never-ending system demands; 4) problems related to paper persistence; 5) untoward changes in communication patterns and practices; 6) negative emotions; 7) generation of new kinds of errors; 8) unexpected changes in the power structure; and 9) overdependence on the technology. Conclusions: Identifying and understanding the types and causes of unintended adverse consequences related to CPOE will enable system developers and implementers to better manage implementation and maintenance of future CPOE projects. Authors: Walsh KE, Adams WG, Bauchner H, Vinci RJ, Chessare JB, Cooper MR, Hebert PM, Schainker EG, Landrigan CP (2006) Journal: Pediatrics Design: Retrospective descriptive study whereby a total of 352 randomly selected inpatient 5

6 Journal of Healthcare Management 56: 1 January/ February 2011 pediatric admissions were reviewed for identification of medication errors, 3 to 12 months following CPOE implementation Findings: Found total of 104 medication errors among 6,916 medication errors in 1,930 patients days, including 36 serious medication errors per 1,000 patient days. 19% were computer related equating to 10 errors per 1,000 patient days including duplicate orders, drop-down menu selection errors, keypad entry errors, and order set errors. Four preventable adverse drug events in drug ordering occurred that were not CPOE related but were not prevented by CPOE. Conclusions: Serious pediatric CPOE-related errors are uncommon (3.6 errors per 100 patient days) but CPOE can introduce new medication errors that are not seen in a paper-based system. Authors: Zhan C, Hicks RW, Blanchette CM, Keyes MA, Cousins DD (2006) Journal: American Journal of Health-System Pharmacists Design: Retrospective comparison study on medication errors reportedly caused by CPOE Findings: Facilities with CPOE reported fewer inpatient medication errors and more outpatient medication errors than facilities without CPOE. Facilities with CPOE less frequently reported medication errors that reached the patient. The most common CPOE errors were dosing errors (wrong dose, wrong dosage form, or extra dose) as a result of faulty computer interface, miscommunication with other systems, and lack of adequate decision support. Human error was also involved such as knowledge deficit, distraction, and typing errors. Conclusions: National voluntary database is useful in providing valuable information on the types of CPOE-related medication errors. Authors: Ash JS, Sittig DF, Poon EG, Guappone K, Campbell E, Dykstra RH (2007) Design: Descriptive study using telephone survey with an interview script including the purpose of the survey, five questions about the kinds of CPOE system in place, and eight questions about possible unintended consequences and the related importance Findings: Hospitals reported experiencing all eight types of unintended consequences. Those considered most important included new work/more work, work flow, system demands, communication, emotions, and dependence on the technology. No relationship was found between kinds of unintended consequences and number of years using CPOE. Conclusions: Unintended consequences of CPOE are widespread and can be positive, negative, or both. They continue to exist over the duration of use. Aggressive detection and management of adverse unintended consequences is imperative. Authors: Donyai P, O Grady K, Jacklin A, Barber N, Franklin BD (2007) Journal: British Journal of Clinical Pharmacology Design: Comparison study of prescribing errors and pharmacists interventions during a 4- week period both pre- and post-electronic prescribing Findings: The study highlighted new error types related to electronic prescribing (EP). 6

7 Published Research on EMR- Related Errors, These mainly involved selection of the incorrect dose or frequency from a menu, and inappropriate use or selection of default doses. Conclusions: Prescribers and pharmacists need to be aware of new types of errors to reduce clinical risk. Pharmacists may need to change the way they work to complement rather than duplicate the benefits of EP. Authors: Chuo J, Hicks RW (2008) Journal: Clinics in Perinatology Design: Retrospective descriptive study of computerized physician order entry or computer entry errors Findings: Found 343 NICU medication errors from computer entry (n = 298) or CPOE (n = 45). One-third of computer-entry errors reached patients (34%); some required interventions to prevent harm, and some resulted in harm (7%). 75% of CPOE were recognized before reaching patients. Contributing factors that most affected CPOE errors included distractions, staff inexperience, insufficient staffing, and workload. Action to patients more often included laboratory tests, drug therapy initiated/changed, and observation initiated/increased following computer errors. CPOE errors resulted more often in action such as vital signs monitoring and delay in diagnosis and treatment. Conclusions: As dispensing technology has become more effective in preventing medication errors, there has been an increase in prescription and transcription errors. Authors propose strategy in five areas to evaluate technology: context, unit attributes, personnel, performance, and cost. Authors: Santell JP, Kowiatek JG, Weber RJ, Hicks RW, Sirio CA (2009) Journal: American Journal of Health-System Pharmacists Design: Retrospective comparison study of computer-related medication errors made by nonprescribers including severity, origin within the medication-use process, type, principal cause, location, and therapeutic drug class Findings: Performance deficit was leading cause of errors and percentage of harm was small. Inpatient pharmacy was location where most computer-entry errors occurred in both facilities within the MEDMARX database and University of Pittsburgh Medical Center. Conclusions: Computer systems create new opportunities for errors. Authors: Singh H, Mani S, Espadas D, Petersen N, Franklin V, Petersen LA (2009) Journal: Archives of Internal Medicine Design: Descriptive study of inconsistent communication in CPOE, defined as occurring when there was discordance between information entered through the structured template and the free-text comment field Findings: Of 55,992 new prescriptions, 532 (0.95%) contained inconsistent communication. Drug dosage was most common. Approximately 20% of the errors could have resulted in moderate to severe harm, for which significant predictors were identified. Conclusions: Inconsistent communication in CPOE poses a significant risk to patient safety. Improving usability and work flow may reduce the risk. 7

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