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How Can Information Technology Improve Patient Safety and Reduce Medication Errors in Children's Health Care?
Rainu Kaushal, MD, MPH;
Kenneth N. Barker, PhD;
David W. Bates, MD, MSc
Arch Pediatr Adolesc Med. 2001;155:1002-1007.
ABSTRACT
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Background Medication errors are common, costly, and injurious to patients.
Objective To review the role of information technology in decreasing pediatric
medication errors in both inpatient and outpatient settings.
Design We performed a literature review of current information technology interventions.
Results Several types of information technology will likely reduce the frequency
of medication errors, although insufficient data exists for many technologies,
and most available data come from adult settings. Computerized physician order
entry with decision support substantially decreases the frequency of serious
inpatient medication errors in adults. Certain other inpatient information
technologies may be beneficial even though less evidence is currently available.
These include computerized medication administration records, robots, automated
pharmacy systems, bar coding, "smart" intravenous devices, and computerized
discharge prescriptions and instructions. In the outpatient setting, where
adherence is especially important, personalized Web pages and World Wide Web–based
information have substantial potential.
Conclusions Medication errors are an important problem in pediatrics. Information
technology interventions have great potential for reducing the frequency of
errors. The magnitude of benefits may be even greater in pediatrics than in
adult medicine because of the need for weight-based dosing. Further development,
application, evaluation, and dissemination of pediatric-specific information
technology interventions are essential.
INTRODUCTION
THE 1999 Institute of Medicine report dramatically increased public
awareness of medical error. It estimated that each year 44 000 to 98 000
people die of an iatrogenic injury, either as a main or a contributing cause,
and that 1.3 million are injured by medical treatment.1, 2
The mortality estimates were extrapolated primarily from 2 large studies,
one in New York State (the Harvard Medical Practice Study)3
and the other in Colorado and Utah.4 Even though
some controversy surrounds the accuracy of these mortality estimates,5, 6, 7 all agree that the number
of deaths attributable to iatrogenic injury is too high. In this article we
review the epidemiology of medication errors and adverse drug events (ADEs)
and discuss the evidence for the potential benefit of information technology
in reducing them.
ADEs AND MEDICATION ERRORS IN THE INPATIENT SETTING
The 1984 Harvard Medical Practice Study demonstrated an overall adverse
event rate of 3.7 per 100 admissions for inpatients, and 0.6 and 2.1 per 100
admissions for newborns and children aged 15 years or younger, respectively
(President and Fellows of Harvard College, unpublished data, 1990). The most
common adverse events in this study were complications of medication use (19.4%)
followed by wound infections, operative complications, and diagnostic mishaps.8 Of these adverse events, 71% resulted in a disability
that lasted less than 6 months, 3% caused permanently disabling injuries,
and 14% led to death.3
Although the Harvard Medical Practice Study found that 69% of iatrogenic
injuries were preventable,2 it did not provide
sufficient detail to develop prevention strategies. A few studies have addressed
common iatrogenic events such as operative complications or diagnostic mishaps,
but more have focused on complications of medication use. Investigators at
Harvard Medical School (Boston, Mass) performed the Adverse Drug Event Prevention
Study to gain a more detailed understanding of medication errors and ADEs
in hospitalized adults.9, 10
In this study, researchers defined medication errors as errors in drug
ordering, transcribing, dispensing, administering, or monitoring. An example
would be an order written for an albuterol sulfate inhaler without specifying
a frequency. Some medication errors are likely to injure patients and are
considered potential ADEs. An example of a potential ADE would be the administration
of an overdose of gentamicin sulfate without any resulting sequelae. Adverse
drug events are injuries that result from the use of a drug. Preventable ADEs
are associated with medication errors, whereas nonpreventable ADEs are not.
An example of a preventable ADE is the development of a cefazolin sodium–associated
rash in a patient with a known allergy to cephalosporins. In contrast, a nonpreventable
ADE is the development of a cefazolin-associated rash in a patient without
a known cephalosporin allergy. Figure 1depicts the relationship among medication errors, potential ADEs, and ADEs.
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The relationship between medication errors, potential adverse drug
events (ADEs), and ADEs.
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The Adverse Drug Event Prevention Study found that ADEs occurred at
a rate of 6.5 per 100 adult admissions.9 These
ADEs were costly and many had severe sequelae.11, 12
Several studies suggest that about one third of ADEs are associated with medication
errors. In another study, Bates et al13 found
a rate of 5 medication errors per 100 medication orders. They also found that
7 in 100 errors have the potential for harm and that 1 in 100 errors actually
result in an injury.14
ADEs AND MEDICATION ERRORS IN THE PEDIATRIC INPATIENT SETTING
Much less information is available regarding the epidemiology of medication
errors and ADEs in pediatric inpatient settings. Pediatric studies must be
performed because children pose special challenges to the medication-processing
system at all stages. Ordering medications typically involves more calculations
in pediatrics compared with adult medicine because weight-based dosing is
needed for virtually all drugs. At the pharmaceutical-dispensing stage, few
drugs are preprepared in doses appropriate for children. This necessitates
the frequent dilution of stock medications, creating opportunities for error
in either calculating or performing a dilution. In addition, young children
have less developed communication skills than adults, limiting feedback to
medical providers (pediatricians, family practice physicians, nurse practitioners,
physician assistants, etc) about potential adverse effects or mistakes in
medication administration. Finally, neonates have less internal reserves with
which to buffer errors compared with adults. For example, an infant is less
equipped to compensate for an overdose of narcotics than an older child or
adult.
Folli et al15 performed a major pediatric
study in 1987. They identified 0.45 to 0.49 ordering errors per 100 medication
orders using a pharmacy-based review in 2 pediatric hospitals for 6 months.
They found that pediatric patients aged 2 years and younger and pediatric
intensive care unit patients were particularly susceptible to physician error.
The most common type of errors were dosing errors. Antibiotics were most commonly
involved.
In 1999, we studied medication errors and ADES in 2 academic pediatric
hospitals. Using active data collection methods similar to those of our previous
studies, we found a medication error rate of 6 per 100 orders.16
Most of these errors occurred during the physician ordering of medication
and involved incorrect dosing. Although the medication error rates were similar
in pediatric and adult hospitals, potential ADEs were about 3 times more frequent
in the pediatric setting. We found that potential ADEs occurred particularly
often in newborns in the neonatal intensive care unit. Most potential ADEs
occurred at the stage of drug ordering (79%) and involved incorrect dosing
(34%).
ADEs AND MEDICATION ERRORS IN OUTPATIENTS
Compared with the inpatient setting, fewer studies have evaluated the
epidemiology of medication errors and ADEs in the ambulatory setting. Therapeutic
drugs are used frequently in our society; 75% of office visits to general
practitioners and internists are associated with the continuation or initiation
of a drug.17 In one study, 31.5% of patients
recently discharged from a hospital reported an ADE18;
another study found that 5% of patients per year report an ADE.19
The Ambulatory Medicine Quality Improvement Project study was a cross-sectional
medical record review and patient survey of adult primary care patients at
11 ambulatory clinic sites.20 Of the 2248 patients
who used prescription drugs, 394 (18%) reported problems related to their
medications, suggesting that medication errors and ADEs are common in outpatients.
Few data are available regarding the frequency of medication errors
or ADEs in the pediatric ambulatory setting, although it is likely that outpatient
drug errors are a major problem. Several factors complicate ambulatory drug
use, including the need for rapid dose calculations, clear communication between
health care providers (pediatricians, family practice physicians, nurse practitioners,
physician assistants, etc) and parents and other guardians, and effective
interactions between children and caregivers. For example, a pediatrician
diagnoses a 2-year-old with an ear infection and decides to prescribe acetaminophen
and amoxicillin. The physician must calculate the drug doses by converting
the child's weight from pounds to kilograms, calculating a 24-hour milligram-per-kilogram
dose, and then dividing this dose by the frequency to determine an individual
dose. The most appropriate drug preparation must then be chosen. The physician
must write legible and complete prescriptions and provide appropriate administration
instructions to the parent. For example, one documented mistake involved using
an infant acetaminophen dropper to administer the elixir, resulting in a significant
underdose.21 Conversely, using a teaspoon to
administer the highly concentrated infant drops can cause an overdose and
potential hepatotoxicity. The pharmacist must dispense the correct medication
and provide further instructions. Finally, the child must ingest the medications.
Clearly this is a complex process occurring in multiple settings, which may
make the ambulatory pediatric setting more prone to errors than the inpatient
setting.
ERROR PREVENTION: THE SYSTEMS APPROACH
Human factors research incorporates themes from industrial engineering,
cognitive psychology, and sociology. Regarding the etiology of errors, this
research typically focuses on problems in systems rather than individual blame.22, 23, 24, 25, 26, 27
The safest work environments address errors by educating personnel, creating
a blame-free culture, reengineering systems (through simplification, standardization,
and use of constraints and forcing functions), and introducing checks to intercept
errors before they reach the patient. System improvements can be broadly divided
into organizational changes of the institution and its personnel or process
changes in the medication system. An example of an organizational change is
the introduction of a ward-based clinical pharmacist with a continuous quality
improvement team. In contrast, most information technology applications are
examples of process changes.
ERROR PREVENTION AND INFORMATION TECHNOLOGY IN THE INPATIENT SETTING
Although information technology is a powerful tool to reduce medication
errors, it is not a panacea. Examples of interventions include computerized
physician order entry (CPOE) and decision support, computerized medication
administration records, robots, automated pharmacy systems, bar coding, "smart"
intravenous devices, and computerized discharge prescriptions and instructions.
Computerization of ordering is a powerful intervention for improving
drug safety because ordering errors are a frequent type of medication error.13, 16 The physician may write an incomplete
or incorrect order that omits dose, route, or frequency. Other errors include
illegible orders or the use of nonstandard terminology. Computerized order
entry is a logical intervention to combat such errors by ensuring that the
order is complete, legible, and in a standard format.
Computerized clinical decision support adds substantial value when integrated
with CPOE by providing feedback to the physician at the point of order creation.
Software can check the ordered drug with patient characteristics such as weight,
allergies, the use of other drugs, and laboratory values. An example of a
drug and laboratory value check is the computerized ordering of potassium
with a corner screen display that includes the patient's present potassium
and creatinine values.
In addition, physicians are much less likely to err when initially directed
to an appropriate dose, route, or frequency. In a well-known case in Denver,
Colo, benzathine penicillin, an intramuscular medication, was given intravenously
and resulted in an infant's death.28 A computerized
forcing function could have prevented the ordering of this medication intravenously.
In a time series analysis, Bates et al29
demonstrated an initial 64% reduction in all medication errors in an adult
hospital using a CPOE system with only basic decision support, and an 83%
reduction with more advanced decision support. In an elegant series of studies
from LDS Hospital in Salt Lake City, Utah, researchers demonstrated that a
computerized clinical decision support program significantly reduced antibiotic-associated
medication errors and ADEs as well as costs.30
Mullett et al31 designed a pediatric anti-infective
decision support tool and demonstrated significantly fewer erroneous drug
orders.
Designing and implementing effective CPOE with decision support is more
difficult in pediatrics compared with adult medicine. Because most pediatric
medication dosing is weight-dependent, pediatric computer applications must
allow easy updating of a patient's weight, a daily requirement for neonates.
Similarly, normal laboratory value ranges such as creatinine vary greatly
as a child matures, necessitating customized checks. These issues suggest
that computerization of ordering may be especially beneficial in pediatrics.
Computerization of the Medication Administration Record
Coupling of computerized records of medication administration with CPOE
can eliminate many transcription errors, a common type of medication mistake.
This also allows for cumulative dose checking, which is particularly important
for medications administered on a per-need basis. However, few available data
evaluate the effects of computerizing this process.
Automated Dispensing
Many hospitals have used robots, which recognize medications using bar
codes, to automate the prescription-filling process. In one unpublished study,
a robot decreased the dispensing error rate from 2.9% to 0.6% in an adult
hospital (P. E. Weaver, PharmD, unpublished data, 1998). Automating this process
may be more difficult in pediatrics because of small dosages.
Automated Drug Administration
Automated pharmacy systems featuring computer-controlled devices that
package, dispense, distribute, and/or control medications have the potential
to reduce administration errors. In 1969, one study documented a decrease
in medication administration errors from 13% to 1.9% by introducing a medication
profile-linked dispensing envelope system.32
In 1984, Barker et al33 demonstrated that an
automated dispensing device at the bedside reduced errors, particularly errors
of time and omission. This dispensing device sounded an alert when a medication
was due for administration and restricted access to only those particular
medications. In contrast, Barker and Allan34
demonstrated an increase in errors with a different automated device used
in the nursing unit. This device allowed nurses to obtain any medicine stored
for any patient and did not integrate the computerized medication profiles
of patients. The investigators attributed the increase in errors to nurses
more commonly administering drugs from the automated device without checking
them compared with drugs taken from the patient's medication drawer. This
example highlights the importance of testing information technology interventions
prior to widespread use and dissemination.
Bar coding may also reduce error rates in medication administration.35 Many industries use this system, resulting in error
rates of about 1 in a million compared with 1 in 300 for keyboard entry. However,
the lack of a common approach by drug manufacturers to bar coding has hindered
its use in medicine. Some individual hospitals have recoded medications at
a relatively modest expense. Bar coding allows rapid identification of the
drug name, drug dose, and administration time as well as staff and patient
names. Meyer et al36 demonstrated that bar
coding could save 1.52 seconds per dose and improve accuracy. Easy and correct
matching of drug to patient is particularly important in pediatrics because
of the limited communication skills of children. A child is much less likely
than an adult to recognize an incorrect medication intended for another patient.
Concord Hospital in Concord, NH, introduced bar coding and found an 80% decrease
in administration errors (D. DePiero, PharmD, oral communication, 2000).
Many errors occur with the delivery of intravenous medications.37 Smart intravenous devices are pumps that reduce the
chance of error through simplified programming and computerized checks. Such
pumps are especially important for reducing the likelihood of 10-fold overdoses,
a major problem in pediatrics.38
Computerized Discharge Prescriptions and Instructions
In addition to decreasing medication errors within the ambulatory and
hospital settings, information technology can bridge these settings to further
reduce communication errors. For example, computers can generate medication
instructions and prescriptions at hospital discharge. If an integrated computer
system exists, discharge information can be easily exchanged among the inpatient,
outpatient, and emergency department settings. The computer system at Harvard
Vanguard (Boston, Mass) allows such integration and also includes pharmacy
and laboratory data.39
ERROR PREVENTION AND INFORMATION TECHNOLOGY IN THE OUTPATIENT SETTING
The issues confronting physicians ordering medications in the ambulatory
setting are different from those in the hospital setting. Computerized physician
order entry with clinical decision support should be equally if not more useful
in the ambulatory setting, although clinicians may prefer handheld devices
for their mobility. Computerized transcription with direct relay of entered
orders to a chosen pharmacy could further decrease ambulatory medication errors.
In addition, robots might assist pharmacists in this setting.
For pediatrics, special information technology interventions are needed
at the administering stage. One unusual aspect of the pediatric ambulatory
setting is that parents, rather than patients or trained nurses, administer
most medications. Several studies have documented error-prone aspects of this
process, including parental confusion regarding the correct use of teaspoons,
tablespoons, and dose cups.21, 40, 41
Parents generally rely on information from physicians and pharmacists regarding
appropriate drug administration, yet these interactions are often rushed.
World Wide Web–based information on drugs could supplement verbal information,
thereby conveniently educating parents who have Internet access.42
Of course, such interventions raise issues of patient confidentiality that
must be addressed. Many children with chronic illnesses such as asthma receive
medications at school. Personalized Web pages could provide school nurses
with information on a child's medication regimen.
Parental review of a computerized medication record may further reduce
ambulatory medication errors. Kuperman et al43
created an application that allowed patients in 4 clinics to review paper
forms of computerized data on medication, health maintenance, and allergies.
Patients added new medication data to 19% of forms, enabling physicians to
address discrepancies and update the computerized record during their visit.
PREVALENCE OF EXISTING TECHNOLOGY
Few data exist regarding the prevalence of information technology interventions,
although it appears that less than 5% of US hospitals currently have CPOE
in place.44 One pediatric hospital that has
implemented this technology is the Alfred I. duPont Hospital for Children
in Wilmington, Del (S. Levine, PharmD, oral communication, 2000). Among the
approximately 230 hospital-based robots presently being used, 3 of these are
in freestanding pediatric institutions (P. Pierpaoli, MS, oral communication,
2000). The Department of Veterans Affairs hospitals are presently adopting
bar coding. In addition, at least 11 medical technology firms currently offer
19 different automated pharmacy systems, and 55% of hospitals use such devices.45
FUTURE AGENDA FOR INFORMATION TECHNOLOGY AND PEDIATRIC PATIENT SAFETY
Although only limited data are available, it appears likely that medication
errors are a major problem in children's health care today. Information technology,
especially CPOE with clinical decision support, is a powerful tool that has
already proved to decrease medication errors. However, the development of
pediatric-specific information technology is essential.
The first step in a pediatric patient safety and information technology
research agenda is a more rigorous determination of the epidemiology of iatrogenic
injuries in children. Further studies need to examine nosocomial infections,
operative complications, diagnostic mishaps, and medication errors. These
epidemiological studies are necessary for 2 reasons: (1) root cause analysis
of errors allows for informed innovation and application of information technology
interventions; and (2) determination of error rates allows an accurate baseline
against which to measure the effects of interventions from both the patient
safety and economic perspectives.
Once researchers more clearly define the epidemiology of iatrogenic
injury in children, they must develop pediatric-specific interventions. The
next and perhaps most important step will be application and testing; some
interventions can actually increase the rates of medication errors.33 In contrast, appropriately designed and implemented
information technology interventions can reduce errors by organizing information
in a timely manner, identifying links between pieces of information, and doing
repetitive tasks. Careful testing also allows prioritization, which is valuable
because of the limited available resources.
The final step will be dissemination of interventions. This step is
critical in pediatrics, where creating technology interventions is specialized,
costly, and time-consuming. The ultimate goal is to create systems that allow
people to spend more time on complex decisions by reducing menial tasks through
information technology.
AUTHOR INFORMATION
What This Study Adds
Medication errors and ADEs are common, costly, and injurious to patients.
It is important to implement strategies to decrease errors. This paper reviews
the role of information technology in decreasing pediatric medication errors
in both inpatient and outpatient settings.
Information technology interventions have great potential for reducing
the frequency of errors. The magnitude of benefits may be even greater in
pediatrics than in adult medicine because of the need for weight-based dosing.
Further development, application, evaluation, and dissemination of pediatric-specific
information technology interventions are essential.
The second article in this series will appear next month.
Accepted for publication March 1, 2001.
We would like to thank Erin Hartman, MS, for her review of the manuscript.
From the Division of General Internal Medicine, Department of Medicine,
Brigham and Women's Hospital and Harvard Medical School, Boston, Mass (Drs
Kaushal and Bates); and the School of Pharmacy, Auburn University, Auburn,
Ala (Dr Barker).
Corresponding author and reprints: Rainu Kaushal, MD, MPH, Division
of General Medicine, Floor PBBA 3, Brigham and Women's Hospital, 75 Francis
St, Boston, MA 02115 (e-mail: rkaushal{at}partners.org).
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Pediatrics 2004;113:59-63.
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The Impact of Dedicated Medication Nurses on the Medication Administration Error Rate: A Randomized Controlled Trial
Greengold et al.
Arch Intern Med 2003;163:2359-2367.
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Medication Errors
Thomas
CLIN PEDIATR 2003;42:287-294.
Resident Documentation Discrepancies in a Neonatal Intensive Care Unit
Carroll et al.
Pediatrics 2003;111:976-980.
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Prioritizing Strategies for Preventing Medication Errors and Adverse Drug Events in Pediatric Inpatients
Fortescue et al.
Pediatrics 2003;111:722-729.
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Central Challenges Facing the National Clinical Research Enterprise
Sung et al.
JAMA 2003;289:1278-1287.
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Incidence and Preventability of Adverse Drug Events Among Older Persons in the Ambulatory Setting
Gurwitz et al.
JAMA 2003;289:1107-1116.
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Letter from the authors of "Improved Growth in Young Children with Severe Chronic Renal Insufficiency Who Use Specified Nutritional Therapy," which appeared on pages 2418-2426 of the November 2001 issue of JASN.
Parekh et al.
J. Am. Soc. Nephrol. 2002;13:1421-1422.
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Information Technology for Children's Health and Health Care: Report on the Information Technology in Children's Health Care Expert Meeting, September 21-22, 2000
Shiffman et al.
J. Am. Med. Inform. Assoc. 2001;8:546-551.
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Information Technology and the Future of Child Health Care: A Revolution Is Occurring
Weitzman and Shiffman
Arch Pediatr Adolesc Med 2001;155:990-991.
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