throbber
Computerized Physician Order Entry and Medication Errors in a
`Pediatric Critical Care Unit
`
`Amy L. Potts, PharmD*; Frederick E. Barr, MD, MSCI‡; David F. Gregory, PharmD, BCPS*;
`Lorianne Wright, PharmD*; and Neal R. Patel, MD, MPH‡§
`
`ABSTRACT. Objective. Medication errors are a major
`concern of health care professionals and medical institu-
`tions, especially errors involving children. Studies in
`adults have shown that computerized physician order
`entry (CPOE) systems reduce medication errors and ad-
`verse drug events (ADEs). The effect of CPOE implemen-
`tation in a pediatric population has not been reported.
`The objective of this study was to evaluate the impact of
`CPOE on the frequency of errors in the medication or-
`dering process in a pediatric critical care unit (PCCU).
`Methods. A prospective trial was conducted of 514
`pediatric patients who were admitted to a 20-bed PCCU
`in a tertiary-care children’s hospital before and after im-
`plementation of CPOE. Medication errors were identi-
`fied after review of all orders during the study period
`and then further classified as potential ADEs, medication
`prescribing errors (MPE), and rule violations (RV).
`Results. A total of 13 828 medication orders were re-
`viewed. Before implementation, potential ADEs occurred
`at a rate of 2.2 per 100 orders, MPEs at a rate of 30.1 per
`100 orders, and RVs at a rate of 6.8 per 100 orders. After
`implementation, the rate of potential ADEs was reduced
`to 1.3 per 100 orders, MPEs to 0.2 per 100 orders, and RVs
`to 0.1 per 100 orders. The overall error reduction was
`95.9%. Potential ADEs were reduced by 40.9%, and MPEs
`and RVs were reduced by 99.4% and 97.9%, respectively.
`Conclusions. The implementation of CPOE resulted
`in almost a complete elimination of MPEs and RVs and a
`significant but less dramatic effect on potential ADEs.
`Pediatrics 2004;113:59 – 63; medication errors, critical care,
`pediatrics, clinical decision support systems; computer-
`assisted drug therapy.
`
`ABBREVIATIONS. ADE, adverse drug event; CPOE, computer-
`ized physician order entry; IOM, Institute of Medicine; PCCU,
`pediatric critical care unit; MPE, medication prescribing error; RV,
`rules violation.
`
`Medication errors are a major concern of
`
`health care professionals and medical insti-
`tutions, especially errors involving chil-
`dren. Children have significant differences in both
`
`From the *Department of Pharmaceutical Services, Vanderbilt Children’s
`Hospital, Nashville, Tennessee; ‡Division of Pediatric Critical Care and
`Anesthesia, Department of Pediatrics, Vanderbilt Children’s Hospital,
`Nashville, Tennessee; and §Department of Biomedical Informatics, Vander-
`bilt University, Nashville, Tennessee.
`Received for publication Oct 28, 2002; accepted Apr 8, 2003.
`Reprint requests to (N.R.P.) Department of Pediatrics, Anesthesiology and
`Biomedical Informatics, Division of Pediatric Critical Care and Anesthesia,
`Vanderbilt Children’s Hospital, 714 Medical Arts Bldg, Nashville, TN
`37212-1565. E-mail: neal.patel@vanderbilt.edu
`PEDIATRICS (ISSN 0031 4005). Copyright © 2004 by the American Acad-
`emy of Pediatrics.
`
`pharmacokinetics and pharmacodynamics compared
`with adults that can make this population more sus-
`ceptible to medication errors and related injuries.
`Several factors make children in a critical care setting
`especially vulnerable to medication errors and ad-
`verse events. These factors include weight-based
`dosing, significant weight changes over a relatively
`short period of time, lack of commercially available
`products leading to dilution of stock medications,
`and the decreased communication ability of critically
`ill patients.1,2 These problems are magnified by the
`use of vasoactive infusions and the emergent use of
`drugs during cardiopulmonary resuscitation. Each
`patient requires complex calculations to determine
`the concentration of many drugs, including vasoac-
`tive agents, to be mixed by the pharmacy and the rate
`of delivery to achieve a desired dose. The process of
`prescribing medications for critically ill children is
`complex and lacks standardization, which can in-
`crease the risk of medication errors and adverse
`events.
`The significance of medication errors in pediatric
`inpatients has only recently been described. Kaushal
`et al1 studied 1120 pediatric patients who were ad-
`mitted to 2 hospitals during a 6-week period. The
`authors analyzed ⬎10 000 medication orders and
`found 616 medication errors, resulting in an error
`rate of 5.7%. This error rate is consistent with the rate
`reported in adults.3 In addition, this study evaluated
`the frequency at which medication errors occurred at
`different points in the medication system.1 Seventy-
`nine percent of potential adverse drug events (ADEs)
`occurred at the time of physician ordering, whereas a
`smaller percentage occurred at the point of transcrip-
`tion or administration.
`Recent trends toward cost containment, standard-
`ization, and accessibility of common medications
`have led to the implementation of various entities of
`automation and technology. Computerized physi-
`cian order entry (CPOE) has been identified by the
`Institute of Medicine (IOM), Leapfrog Group, Insti-
`tute for Safe Medication Practices, American Medical
`Association, American Academy of Pediatrics, and
`others as a tool that may prevent errors that occur
`during the medication ordering process.1,4 –10 The
`Leapfrog Group has also identified CPOE as 1 of 3
`initial hospital safety standards and has described
`several benefits of CPOE that may result in improved
`quality of care and reduced health care costs.5 These
`benefits may include enhanced communication be-
`
`Downloaded from
`
`PEDIATRICS Vol. 113 No. 1 January 2004
`by guest on August 10, 2016
`
`59
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1041 – Page 59
`
`

`
`tween health care professionals through the elimina-
`tion of illegible or incomplete orders and the in-
`creased efficiency of order processing through
`instantaneous transmission of orders to other hospi-
`tal systems. Computerized decision support associ-
`ated with CPOE systems, such as displaying age-
`specific dosing regimens to the user, checking for
`doses above or below the usual range, providing
`warnings if current laboratory values indicate that
`the drug or regimen would be inappropriate for a
`particular patient, and screening for allergies and
`drug–drug interactions may also improve the order-
`ing process.
`The role of CPOE in preventing medication errors
`and ADEs has been noted in the adult literature.
`Bates et al6 evaluated the medication error rates of 3
`medical units before and after CPOE during a 4-year
`period. The authors concluded that CPOE substan-
`tially decreased the rate of medication errors with
`additional reductions observed after the addition of
`decision support and other features. Another study
`evaluated the use of CPOE in an adult population
`and found that serious medication errors were re-
`duced by 55%.7
`The development of CPOE systems that are adapt-
`able to pediatric critical care environments has been
`problematic. Developing systems
`that provide
`weight-based dosing, as well as age-specific algo-
`rithms, is difficult and applicable only to a small
`proportion of the overall health care market. There
`are limited data on the impact of CPOE on medica-
`tion errors in pediatric patients. Most literature has
`evaluated medication errors and ADEs that have
`resulted in patient injury regardless of the point in
`the system at which the error occurred. We evaluated
`medication errors that occurred specifically at the
`time of prescribing rather than administration or
`dispensing. The objective of this study was to deter-
`mine the impact of CPOE on the frequency of med-
`ication errors at the point of physician ordering in a
`pediatric critical care unit (PCCU).
`
`METHODS
`
`Study Setting
`The study was conducted in a 20-bed multidisciplinary PCCU
`at an academic institution located in a major metropolitan area.
`The institution provides services to a diverse socioeconomic pa-
`tient population. The PCCU has an average daily census of 16.3
`patients, and the average length of stay is 4.1 days. The hospital
`cares for both adult and pediatric patients, but pediatric services
`are both geographically and administratively distinct.
`
`Patient Population
`This study included all patients who were admitted to the
`PCCU during the designated study periods and encompassed
`both medical and surgical patients. Disease states represented in
`this patient population included postoperative congenital heart
`defect repair, metabolic disorders, trauma, respiratory diseases,
`bone marrow and solid organ transplantation, and other child-
`hood illnesses.
`
`Study Design
`In this prospective cohort study, a comparison was made be-
`tween the occurrences of errors in the medication ordering process
`before and after implementation of a CPOE system in the PCCU.
`Approval from the Institutional Review Board at Vanderbilt Uni-
`versity Medical Center was obtained. Data were collected before
`
`CPOE implementation for a 2-month period from October 4, 2001,
`to December 4, 2001. There was a 1-month period when no data
`were collected to allow for CPOE implementation and training of
`all attendings, fellows, residents, and staff. Post-CPOE data col-
`lection then occurred for a 2-month period from January 4, 2002, to
`March 4, 2002.
`
`Computer Systems
`WizOrder is a CPOE system developed in 1994 by the faculty in
`the division of Biomedical Informatics at Vanderbilt University.11
`WizOrder is the precursor to the commercially available Horizon
`Expert Order system (McKesson, Atlanta, GA) and currently in-
`terfaces with the Pyxis Medstation 2000 system (Pyxis Corp, San
`Diego, CA) and the pharmacy computer system, McKesson Series.
`WizOrder provides clinicians with several types of decision sup-
`port, including drug allergy alerts, dose checking, drug interaction
`alerts, and US Food and Drug Administration alerts. In addition,
`WizOrder includes clinical pathways using ⬎900 preprogrammed
`individual order sets and links to drug monographs, evidence-
`based literature sites, and the National Library of Medicine
`PubMed site. This system also interfaces to a computerized ar-
`chive of medical records that serves as a clinical data repository so
`that order-related and laboratory-related alerts can be generated
`for each individual patient. The depth of clinical decision support
`can be adjusted on the basis of predetermined criteria such as age
`or patient location. Recommendations for medication dosage ad-
`justment for impaired renal function, for example, varies between
`adult and pediatric patients. Adjustments are recommended for
`adult patients on the basis of estimates of creatinine clearance
`using standard formulas. Unfortunately, these formulas cannot
`reliably be used in pediatric patients. For these patients, clinical
`decision support provides only recent laboratory values and an
`alert to take renal function into account during the ordering pro-
`cess. Another aspect of clinical decision support that has been
`implemented is information on varying medication dosage by
`clinical indication. The system calculates the dose once the clini-
`cian selects 1 of the recommendations. WizOrder had been imple-
`mented on all adult units and the general medical/surgical pedi-
`atric wards before its implementation in the PCCU.
`
`Review Process
`All medication orders were included in this analysis except for
`the following: fluids, dialysate, total parental nutrition (TPN)/
`lipids, and chemotherapeutic agents. TPN and lipids had not been
`added to the CPOE system at the time of the study. Fluids,
`dialysate, and chemotherapy orders were entered in the CPOE
`system but will be evaluated at a later date. A designated clinical
`pharmacist reviewed all eligible orders. Errors were entered into a
`database that included information such as patient name, age,
`weight, drug, presence of error, dose, interval, and route. Errors
`were identified and further classified into categories on the basis
`of the definitions and classifications listed in Table 1 and reviewed
`for accuracy and relevance by a second clinical pharmacist. A
`physician reviewer independently evaluated all original medica-
`tion orders for 10% of randomly selected patients in both the
`pre-CPOE and post-CPOE groups to determine level of agreement
`with clinical pharmacists.
`
`Main Outcome Measures
`This study focused on errors that occurred during the medica-
`tion ordering process. An error was determined to have occurred
`when an order was found to be incomplete, incorrect, or inappro-
`priate at the time of physician ordering. Errors were classified as
`potential ADEs, medication prescribing errors (MPEs), or rule
`violations (RVs). A potential ADE was defined as any error that, if
`allowed to reach the patient, could result in patient injury. Poten-
`tial ADEs are those errors in which the ordering physician pro-
`vided incorrect or inappropriate information. They also include
`instances in which the ordering physician failed to account for
`patient-specific information (eg, allergy). MPEs were defined as
`errors in which inadequate information was provided or further
`interpretation (eg, illegibility) was required for the order to be
`processed. RVs were defined as errors that were not compliant
`with standard hospital policies (eg, abbreviations).
`
`60
`
`CPOE AND MEDICATION ERRORS IN A PCCU
`Downloaded from
`by guest on August 10, 2016
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1041 – Page 60
`
`

`
`TABLE 1.
`
`Medication error
`
`Potential ADEs
`Duplicate therapy
`
`Inappropriate dose12
`
`Inappropriate interval12
`Inappropriate route12
`Wrong drug
`Wrong units
`
`Error Classifications and Definitions
`Any order that was incomplete, incorrect, or inappropriate at the time of
`physician ordering
`Any error that, if allowed to reach the patient, could result in patient injury
`Same drug prescribed twice or 2 or more drugs from the same class with
`no evidence-based medicine to prove benefit from both
`Based on a 10% difference in published dosing guidelines or our PCCU
`standards of practice
`Based on differences found from published dosing guidelines
`Drug not available or not recommended to be given in the route ordered
`Incorrect drug ordered
`Units are not correct for drug, diagnosis, or dose used (eg, units/kg/min
`vs mcg/kg/min)
`Documented drug interaction between 2 medications that deems drug
`ineffective or contraindicated (eg, beta-blocker with beta-agonist)
`Documented allergy to drug ordered
`
`Drug interaction
`
`Allergy
`MPE
`Missing information
`
`No weight
`Illegible
`RVs
`Abbreviation
`
`Trailing zeros
`
`Missing route, interval, concentration, rate, or dose that results in an
`incomplete order
`Patient’s weight not available
`Unable to read, required further interpretation
`
`Shortened or symbolized representation of a drug name (eg, dopa, epi,
`MSO4). Does not include CaCl2 or NaHCO3.
`Zeros to the right of the decimal point (eg, 1.0 mg)
`
`Statistical Analysis
`A ␹2 analysis and Fisher exact test for smaller sample sizes were
`used for pre-CPOE and post-CPOE data comparison. The STATA
`statistical program was used for analysis (Stata Corp, College
`Station, TX). The interrater reliability was calculated using the
`percentage of agreement and the ␬ statistic. The ␬ statistic for
`interrater reliability between the physician reviewer and clinical
`pharmacist was 0.96. This corresponds to excellent reliability.
`
`RESULTS
`A total of 13 828 medication orders involving 514
`patients were analyzed throughout the study period.
`A total of 268 patients were evaluated during the
`pre-CPOE study period and 246 patients were eval-
`uated during the post-CPOE period. The mean age of
`patients in the pre-CPOE group was 6.5 ⫾ 12.0 years
`and in the post-CPOE group was 5.4 ⫾ 10.3 years.
`This was not a significant difference between the 2
`groups. Overall length of stay in the PCCU for both
`groups was also not significantly different. The mean
`length of stay was 4.2 ⫾ 10.7 days for the pre-CPOE
`group and 4.1 ⫾ 6.6 days for the post-CPOE group.
`
`During pre-CPOE, 6803 orders were analyzed. A
`total of 2662 (39.1 per 100 orders) errors and RVs
`were identified and are described in further detail in
`Table 2. After additional classification, 2.2 per 100
`orders were identified as potential ADEs, 30.1 per
`100 orders were identified as MPEs, and 6.8 per 100
`orders were identified as RVs. The most common
`errors in the last 2 categories were missing informa-
`tion and abbreviations.
`During post-CPOE, 7025 orders were analyzed
`and a total of 110 (1.6 per 100 orders) overall errors
`and RVs were identified (Table 2). Of those, 1.3 per
`100 orders were categorized as potential ADEs. The
`rate for MPEs and RVs was only 0.2 per 100 orders
`and 0.1 per 100 orders, respectively. CPOE signifi-
`cantly reduced the rate of MPEs and RVs (P ⬍ .001;
`Table 2). Because of almost a complete elimination of
`MPEs and RVs, potential ADEs became the most
`common level of error in the post-CPOE period.
`Errors involving medication dosage and interval
`
`TABLE 2.
`
`Overall Medication Error Analysis Before and After CPOE
`Pre-CPOE (n ⫽ 6803)
`Post-CPOE (n ⫽ 7025)
`Total
`Number Per
`Total
`Number Per
`Number
`100 Orders
`Number
`100 Orders
`
`Potential ADEs
`Duplicate therapy
`Inappropriate dose
`Inappropriate interval
`Inappropriate route
`Wrong drug
`Allergy
`Drug interaction
`Wrong units
`MPEs
`Weight not available
`Missing Information
`Illegible
`RVs
`Trailing zeros
`Abbreviation
`
`147
`4
`53
`24
`6
`6
`1
`1
`52
`2049
`22
`1979
`48
`466
`55
`411
`
`2.2
`0.06
`0.78
`0.35
`0.09
`0.09
`0.01
`0.01
`0.76
`30.1
`0.32
`29.09
`0.71
`6.8
`0.81
`6.04
`
`88
`0
`59
`19
`0
`1
`0
`0
`9
`12
`0
`12
`0
`10
`10
`0
`
`1.3
`0
`0.84
`0.27
`0
`0.01
`0
`0
`0.13
`0.2
`0
`0.17
`0
`0.1
`0.14
`0
`
`P Value
`
`⬍0.001
`⬍.001
`.69
`.39
`.01
`.07
`.49
`.49
`⬍.001
`⬍.001
`⬍.001
`⬍.001
`⬍.001
`⬍.001
`⬍.001
`⬍.001
`
`
`
`by guest on August 10, 2016Downloaded from
`
`ARTICLES
`
`61
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1041 – Page 61
`
`

`
`were the most prevalent potential ADEs. The reduc-
`tion in error rates for dosing (P ⫽ .69) and interval
`(P ⫽ .39) after CPOE implementation was not signif-
`icant.
`Overall, CPOE resulted in a 95.9% (P ⬍ .001) re-
`duction in all types of errors associated with medi-
`cation ordering. Figure 1 shows a significant reduc-
`tion in MPEs (99.4%; P ⬍ .001) and RVs (97.9%; P ⬍
`.001). A smaller but still significant reduction was
`found with potential ADEs (40.9%; P ⬍ .001) after
`CPOE implementation.
`
`DISCUSSION
`During the past decade, the prevention of medica-
`tion errors and ADEs has become a major focus of
`medical institutions. Public knowledge regarding the
`frequency and seriousness of medication errors and
`the steps that patients can take to prevent such
`events from happening has increased accordingly. In
`addition, improving patient safety through reduc-
`tion of medication errors and ADEs has received the
`attention of government officials at both state and
`national levels.
`In 1999, the impact of medical errors was dramat-
`ically publicized by an IOM report, which estimated
`that between 44 000 and 98 000 people die each year
`partly as a result of medical errors.8 This report laid
`out a comprehensive strategy by which government,
`health care providers, and consumers could reduce
`medication errors. Another report of the IOM re-
`leased in March 2001, Crossing the Quality Chasm: A
`New Health System for the 21st Century, focused on
`improving and redesigning the health care system.13
`Prepared by the IOM’s Committee on the Quality of
`Health Care in America, this report recommends the
`use of automated systems for order processing and
`the elimination of handwritten clinical information
`by the end of this decade.
`ADEs are associated with significant morbidity
`and mortality and are often preventable. Classen et
`al14 reported a 2-fold increase in death associated
`
`Fig 1. Comparison of rates of potential ADEs, MPEs, and RV is
`between pre-CPOE and post-CPOE phases. All categories of errors
`decreased significantly (P ⬍ .001) after CPOE implementation. The
`overall reduction was 40.9% (P ⬍ .001) for potential ADEs, 99.4%
`(P ⬍ .001) for MPEs, and 97.9% (P ⬍ .001) for RVs.
`
`with ADEs as well as prolonged hospitalization. In
`another study, Bates et al15 found that 28% of ADEs
`were preventable and that 56% of those occurred at
`the point of medication prescribing. The overall cost
`of ADEs has been estimated to exceed $2000 per
`event, with preventable ADEs associated with an
`annual national cost of ⬎$2 billion.14,16 The Ameri-
`can Academy of Pediatrics has also stated that med-
`ication errors in particular are associated with signif-
`icant morbidity and mortality and increased health
`care costs by an estimated $1900 per patient.9,17 This
`figure does not reflect the additional emotional costs
`incurred by patients and their families.
`Most guidelines that address methods to reduce
`medication errors recommend that institutions im-
`plement CPOE systems. However, there are limited
`data evaluating the impact of CPOE on medication
`errors in the pediatric population. In this study, we
`evaluated errors that occur only during the medica-
`tion ordering process. In addition, the separation of
`potential ADEs, MPEs, and RVs provides for a de-
`tailed analysis of the specific impact of CPOE on
`different types of errors.
`In this study, CPOE significantly reduced all cate-
`gories of errors. MPEs and RVs were virtually elim-
`inated, and potential ADEs were reduced by 40.9%.
`In addition, during the study, there were no reports
`of errors caused by the CPOE system, including no
`reports of orders being entered on the wrong patient.
`MPEs and RVs often lead to confusion and lack of
`efficiency as a result of incorrect or missing informa-
`tion that requires interpretation and clarification by
`pharmacy and nursing personnel. Our study dem-
`onstrated that a major benefit of CPOE is the en-
`hancement of communication between health care
`professionals that subsequently decreases the possi-
`ble misinterpretation of medication orders.
`Potential ADEs were significantly reduced (P ⬍
`.001) but not nearly to the extent of MPEs and RVs.
`Potential ADEs were identified as errors in which
`incorrect or inappropriate information was provided
`or patient-specific factors were not taken into ac-
`count and potential injury could occur to the patient
`if the medication were received as ordered. Overall,
`most types of potential ADEs, including duplicate
`therapy, wrong drug, wrong units, allergy, and drug
`interactions, were eliminated or significantly re-
`duced. This error reduction, when extrapolated an-
`nually, would equate to a decrease of approximately
`300 instances per year in which a potential ADE was
`prevented. However, errors involving dose and in-
`terval showed no significant difference between pre-
`CPOE and post-CPOE. This may be explained by the
`lack of decision support, on initial CPOE implemen-
`tation, that would assist the prescriber in choosing an
`age- and indication-specific dose and interval for the
`patient. This is an area in which additional enhance-
`ments to CPOE systems are needed. Targeted deci-
`sion support associated with CPOE was shown to be
`effective in adult inpatients with renal insufficiency
`by Chertow et al.18 Decision support tools focused on
`pediatric issues such as weight-based calculations for
`infusions and age-specific dosing guidelines may re-
`sult in additional reductions in these types of errors.
`
`62
`
`CPOE AND MEDICATION ERRORS IN A PCCU
`Downloaded from
`by guest on August 10, 2016
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1041 – Page 62
`
`

`
`Our study evaluated medication errors that occur
`at the time of physician ordering. The prevention of
`actual ADEs involves multiple facets of the medica-
`tion delivery process. Kaushal et al1 showed that the
`frequency of preventable ADEs is very low (0.05 per
`100 orders). Despite the significant number of errors
`in the ordering phase of medication delivery, our
`study was not appropriately powered to evaluate the
`impact of CPOE on overall preventable ADEs. An
`appropriately powered study would require a sam-
`ple size that is 20 times the number evaluated in our
`study. Another limitation of our study is that we did
`not investigate how these errors were detected by
`other components of the medication use system, such
`as verification of the order by a pediatric pharmacist
`or review of the order by nursing staff before admin-
`istration.
`Medication error rates have not been well studied
`in pediatrics. The rate reported in this study may
`seem elevated because of our conservative definition
`of errors in the medication ordering process. Limited
`data are available on error rates associated with med-
`ication ordering in the pediatric critical care setting.
`With this study, we have established an error rate for
`a multidisciplinary PCCU that serves a patient pop-
`ulation that is broad in both age and disease state.
`Although CPOE offers significant advantages in
`almost eliminating MPEs and RVs, CPOE is not the
`sole solution for preventing potential ADEs. The ad-
`dition of decision support has previously been
`shown to increase the effectiveness of CPOE in pre-
`venting medication errors in adult patients.6,18 De-
`veloping features that accommodate the wide range
`of ages and weights found in pediatric patients is
`complex.
`Incorporating pediatric-specific dosing
`guidelines and calculators for continuous infusions
`may prove to reduce the incidence of these types of
`errors. Additional evaluation is needed to determine
`the benefits of enhancing CPOE with additional de-
`cision support designed for the pediatric population.
`Specifically, the issues of gestational age, postnatal
`age, and rapid weight changes in neonatal patients
`are currently being incorporated into WizOrder in
`preparation for implementation in our neonatal in-
`tensive care unit. Unfortunately, pediatrics is a small
`portion of the overall CPOE market and limited fi-
`nancial rewards may prevent commercial vendors
`from committing the necessary resources for devel-
`opment of these tools.
`
`CONCLUSIONS
`In conclusion, CPOE significantly reduced and al-
`most completely eliminated MPEs and RVs while
`still demonstrating a significant reduction in the fre-
`quency of potential ADEs. CPOE offers significant
`
`benefits, including ensuring legible and complete
`physician orders. Incorporation of pediatric-specific
`decision support tools into CPOE systems may result
`in even further reductions of potential ADEs leading
`to improved patient safety. Additional evaluation of
`these safety features is needed and will be the focus
`of future studies.
`
`ACKNOWLEDGMENTS
`We do not have any financial ties or obligations to the com-
`mercialization process of WizOrder. This study was not supported
`in any manner by McKesson (Atlanta GA).
`We acknowledge Fred R. Hargrove, RPh, for valuable technical
`assistance with the CPOE WizOrder system and data retrieval.
`
`REFERENCES
`1. Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse
`drug events in pediatric inpatients. JAMA. 2001;285:2114–2120
`2. Kaushal R, Barker KN, Bates DW. How can information technology
`improve patient safety and reduce medication error in children’s health
`care? Arch Pediatr Adolesc Med. 2001;155:1002–1007
`3. Bates DW, Boyle DL, Vander Vliet MB, Schneider J, Leape L. Relation-
`ship between medication errors and adverse drug events. J Gen Intern
`Med. 1995;10:199–205
`4. Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug
`events. ADE Prevention Study Group. JAMA. 1995;274:35–43
`5. The Leapfrog Group. Computer physician order entry (CPOE) fact
`sheet. Available at: www.leapfroggroup.org. Accessed June 11, 2002
`6. Bates DW, Teich JM, Lee J, et al. The impact of computerized physician
`order entry on medication error prevention. J Am Med Inform Assoc.
`1999;6:313–321
`7. Bates DW, Leape LL, Cullen DJ, et al. Effect of computerized physician
`order entry and a team intervention on prevention of serious medica-
`tion errors. JAMA. 1998;280:1311–1316
`8. The Institute of Medicine (US). To Err is Human: Building a Safer Health
`System. Washington, DC: National Academy Press; 1999
`9. American Academy of Pediatrics. Committee on Drugs and Committee
`on Hospital Care. Prevention of medication errors in the pediatric
`inpatient setting. Pediatrics. 1998;102:428–430
`10. Teich JM, Merchia PR, Schmiz JL, Kuperman GJ, Spurr CD, Bates DW.
`Effects of computerized physician order entry on prescribing practices.
`Arch Intern Med. 2000;160:2741–2747
`11. Geissbuhler A, Miller RA. A new approach to the implementation of
`direct care-provider order entry. Proc AMIA Annu Fall Symp. 1996;
`689–693
`12. Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 8th
`ed. Hudson, OH: Lexi-Comp Inc; 2001
`13. The Institute of Medicine (US). Crossing the Quality of Chasm: A New
`Health System for the 21st Century. Washington, DC: National Academy
`Press; 2001
`14. Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug
`events in hospitalized patients: excess length of stay, extra costs, and
`attributable mortality. JAMA. 1997;277:301–306
`15. Bates DW, Cullen J, Laird N, et al. Incidence of adverse drug events and
`potential adverse drug events: implications for prevention. ADE Pre-
`vention Study Group. JAMA. 1995;274:29–34
`16. Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug events in
`hospitalized patients. Adverse Drug Events Prevention Group. JAMA.
`1997;277:307–311
`17. Physician Insurers Association of America. Medication Error Study.
`Washington, DC: Physician Insurers Association of America; 1993
`18. Chertow GM, Lee J, Kuperman GJ, Burdick E, Horsky J, Seger DL, Lee
`R, Mekala A, Song J, Komaroff AL, Bates DW. Guided medication
`dosing for inpatients with renal
`insufficiency. JAMA. 2001;286:
`2839–2844
`
`Downloaded from
`
`by guest on August 10, 2016
`
`ARTICLES
`
`63
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1041 – Page 63
`
`

`
`Computerized Physician Order Entry and Medication Errors in a Pediatric
`Critical Care Unit
`Amy L. Potts, Frederick E. Barr, David F. Gregory, Lorianne Wright and Neal R.
`Patel
` 2004;113;59
`Pediatrics
`
`Updated Information &
`
`Services
`
`including high resolution figures, can be found at:
`
`/content/113/1/59.full.html
`
`References
`
`Citations
`
`Subspecialty Collections
`
`This article cites 12 articles, 2 of which can be accessed free
`at:
` /content/113/1/59.full.html#ref-list-1
`
`
`
`This article has been cited by 91 HighWire-hosted articles:
`
` /content/113/1/59.full.html#related-urls
`
`This article, along with others on similar topics, appears in
`the following collection(s):
`Health Information Technology
` /cgi/collection/health_information_technology_sub
`Hospital Medicine
` /cgi/collection/hospital_medicine_sub
`
`
`
`
`
`Permissions & Licensing
`
`Reprints
`
`
`
`Information about reproducing this article in parts (figures,
`tables) or in its entirety can be found online at:
`
`/site/misc/Permissions.xhtml
`
`Information about ordering reprints can be found online:
`
`/site/misc/reprints.xhtml
`
`PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly
`publication, it has been published continuously since 1948. PEDIATRICS is owned, published,
`and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk
`Grove Village, Illinois, 60007. Copyright © 2004 by the American Academy of Pediatrics. All
`rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
`
`Downloaded from
`
`by guest on August 10, 2016
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1041 – Page 64
`
`(cid:160)(cid:160)
`

`
`Computerized Physician Order Entry and Medication Errors in a Pediatric
`Critical Care Unit
`Amy L. Potts, Frederick E. Barr, David F. Gregory, Lorianne Wright and Neal R.
`Patel
` 2004;113;59
`Pediatrics
`
`The online version of this article, along with updated information and services, is
`located on the World Wide Web at:
`
` /content/113/1/59.full.html
`
`(cid:160)(cid:160)(cid:160)
`
`PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly
`publication, it has been published continuously since 1948. PEDIATRICS is owned,
`published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point
`Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2004 by the American Academy
`of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
`
`Downloaded from
`
`by guest on August 10, 2016
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1041 – Page 65
`
`(cid:160)

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket