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“How Can Information Technology Improve Patient Safety and Reduce Medication Errors in Children’s Health Care?”, (c) Rainu Kaushal, Kenneth N. Barker and David W. Bates, Archives of Pediatrics & Adolescent Medicine, September 2001

The 1999 Institute of Medicine report dramatically increasedpublic awareness of medical error. It estimated that each year44 000 to 98 000 people die of an iatrogenic injury,either as a main or a contributing cause, and that 1.3 millionare injured by medical treatment The mortality estimateswere extrapolated primarily from 2 large studies, one in NewYork State (the Harvard Medical Practice Study) and the otherin Colorado and Utah. Even though some controversy surroundsthe accuracy of these mortality estimates, all agreethat the number of deaths attributable to iatrogenic injuryis too high. In this article we review the epidemiology of medicationerrors and adverse drug events (ADEs) and discuss the evidencefor the potential benefit of information technology in reducingthem.


ADEs AND MEDICATION ERRORS IN THE INPATIENT SETTING

The 1984 Harvard Medical Practice Study demonstrated an overalladverse event rate of 3.7 per 100 admissions for inpatients,and 0.6 and 2.1 per 100 admissions for newborns and childrenaged 15 years or younger, respectively (President and Fellowsof Harvard College, unpublished data, 1990). The most commonadverse events in this study were complications of medicationuse (19.4%) followed by wound infections, operative complications,and diagnostic mishaps. Of these adverse events, 71% resultedin a disability that lasted less than 6 months, 3% caused permanentlydisabling injuries, and 14% led to death.

Although the Harvard Medical Practice Study found that 69% ofiatrogenic injuries were preventable, it did not provide sufficientdetail to develop prevention strategies. A few studies haveaddressed common iatrogenic events such as operative complicationsor diagnostic mishaps, but more have focused on complicationsof medication use. Investigators at Harvard Medical School (Boston,Mass) performed the Adverse Drug Event Prevention Study to gaina more detailed understanding of medication errors and ADEs inhospitalized adults.

In this study, researchers defined medication errors as errorsin drug ordering, transcribing, dispensing, administering, ormonitoring. An example would be an order written for an albuterolsulfate inhaler without specifying a frequency. Some medicationerrors are likely to injure patients and are considered potentialADEs. An example of a potential ADE would be the administration ofan overdose of gentamicin sulfate without any resulting sequelae.Adverse drug events are injuries that result from the use ofa drug. Preventable ADEs are associated with medication errors,whereas nonpreventable ADEs are not. An example of a preventableADE is the development of a cefazolin sodium–associated rashin a patient with a known allergy to cephalosporins. In contrast,a nonpreventable ADE is the development of a cefazolin-associatedrash in a patient without a known cephalosporin allergy. Figure 1depictsthe relationship among medication errors, potentialADEs, and ADEs.

The Adverse Drug Event Prevention Study found that ADEs occurredat a rate of 6.5 per 100 adult admissions These ADEs werecostly and many had severe sequelae. Several studies suggestthat about one third of ADEs are associated with medication errors.In another study, Bates et al found a rate of 5 medicationerrors per 100 medication orders. They also found that 7 in100 errors have the potential for harm and that 1 in 100 errorsactually result in an injury.


ADEs AND MEDICATION ERRORS IN THE PEDIATRIC INPATIENT SETTING

Much less information is available regarding the epidemiologyof medication errors and ADEs in pediatric inpatient settings.Pediatric studies must be performed because children pose specialchallenges to the medication-processing system at all stages.Ordering medications typically involves more calculations inpediatrics compared with adult medicine because weight-baseddosing is needed for virtually all drugs. At the pharmaceutical-dispensingstage, 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 performinga dilution. In addition, young children have less developedcommunication skills than adults, limiting feedback to medicalproviders (pediatricians, family practice physicians, nursepractitioners, physician assistants, etc) about potential adverseeffects or mistakes in medication administration. Finally, neonateshave less internal reserves with which to buffer errors comparedwith adults. For example, an infant is less equipped to compensatefor an overdose of narcotics than an older child or adult.

Folli et al performed a major pediatric study in 1987. Theyidentified 0.45 to 0.49 ordering errors per 100 medication ordersusing a pharmacy-based review in 2 pediatric hospitals for 6months. They found that pediatric patients aged 2 years andyounger and pediatric intensive care unit patients were particularlysusceptible to physician error. The most common type of errorswere dosing errors. Antibiotics were most commonly involved.

In 1999, we studied medication errors and ADES in 2 academicpediatric hospitals. Using active data collection methods similarto those of our previous studies, we found a medication errorrate of 6 per 100 orders. Most of these errors occurred duringthe physician ordering of medication and involved incorrectdosing. Although the medication error rates were similar inpediatric and adult hospitals, potential ADEs were about 3 timesmore frequent in the pediatric setting. We found that potentialADEs occurred particularly often in newborns in the neonatalintensive care unit. Most potential ADEs occurred at the stageof drug ordering (79%) and involved incorrect dosing (34%).


ADEs AND MEDICATION ERRORS IN OUTPATIENTS

Compared with the inpatient setting, fewer studies have evaluatedthe epidemiology of medication errors and ADEs in the ambulatorysetting. Therapeutic drugs are used frequently in our society;75% of office visits to general practitioners and internistsare associated with the continuation or initiation of a drug.In one study, 31.5% of patients recently discharged from a hospitalreported an ADE; another study found that 5% of patients peryear report an ADE.

The Ambulatory Medicine Quality Improvement Project study wasa cross-sectional medical record review and patient survey ofadult 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 thatmedication errors and ADEs are common in outpatients.

Few data are available regarding the frequency of medicationerrors or ADEs in the pediatric ambulatory setting, althoughit is likely that outpatient drug errors are a major problem.Several factors complicate ambulatory drug use, including theneed for rapid dose calculations, clear communication between healthcare providers (pediatricians, family practice physicians, nursepractitioners, physician assistants, etc) and parents and otherguardians, and effective interactions between children and caregivers.For example, a pediatrician diagnoses a 2-year-old with an earinfection and decides to prescribe acetaminophen and amoxicillin.The physician must calculate the drug doses by converting thechild’s weight from pounds to kilograms, calculating a 24-hourmilligram-per-kilogram dose, and then dividing this dose bythe frequency to determine an individual dose. The most appropriatedrug preparation must then be chosen. The physician must writelegible and complete prescriptions and provide appropriate administration instructionsto the parent. For example, one documented mistake involvedusing an infant acetaminophen dropper to administer the elixir,resulting in a significant underdose. Conversely, using ateaspoon to administer the highly concentrated infant dropscan cause an overdose and potential hepatotoxicity. The pharmacistmust dispense the correct medication and provide further instructions.Finally, the child must ingest the medications. Clearly thisis a complex process occurring in multiple settings, which may makethe ambulatory pediatric setting more prone to errors than theinpatient setting.


ERROR PREVENTION: THE SYSTEMS APPROACH

Human factors research incorporates themes from industrial engineering, cognitivepsychology, and sociology. Regarding the etiology of errors,this research typically focuses on problems in systems ratherthan individual blame. The safest workenvironments address errors by educating personnel, creating ablame-free culture, reengineering systems (through simplification,standardization, and use of constraints and forcing functions),and introducing checks to intercept errors before they reachthe patient. System improvements can be broadly divided intoorganizational changes of the institution and its personnelor process changes in the medication system. An example of anorganizational change is the introduction of a ward-based clinicalpharmacist with a continuous quality improvement team. In contrast,most information technology applications are examples of processchanges.


ERROR PREVENTION AND INFORMATION TECHNOLOGY IN THE INPATIENT SETTING

Although information technology is a powerful tool to reducemedication errors, it is not a panacea. Examples of interventionsinclude computerized physician order entry (CPOE) and decisionsupport, computerized medication administration records, robots,automated pharmacy systems, bar coding, “smart” intravenousdevices, and computerized discharge prescriptions and instructions.

Computerization of ordering is a powerful intervention for improving drugsafety because ordering errors are a frequent type of medicationerror. The physician may write an incomplete or incorrectorder that omits dose, route, or frequency. Other errors include illegibleorders or the use of nonstandard terminology. Computerized order entryis a logical intervention to combat such errors by ensuringthat the order is complete, legible, and in a standard format.

Computerized clinical decision support adds substantial valuewhen integrated with CPOE by providing feedback to the physicianat the point of order creation. Software can check the ordereddrug with patient characteristics such as weight, allergies,the use of other drugs, and laboratory values. An example ofa drug and laboratory value check is the computerized orderingof potassium with a corner screen display that includes thepatient’s present potassium and creatinine values.

In addition, physicians are much less likely to err when initiallydirected to an appropriate dose, route, or frequency. In a well-knowncase in Denver, Colo, benzathine penicillin, an intramuscularmedication, was given intravenously and resulted in an infant’sdeath.28 A computerized forcing function could have preventedthe ordering of this medication intravenously.

In a time series analysis, Bates et al demonstrated an initial64% reduction in all medication errors in an adult hospitalusing a CPOE system with only basic decision support, and an83% reduction with more advanced decision support. In an elegantseries of studies from LDS Hospital in Salt Lake City, Utah,researchers demonstrated that a computerized clinical decisionsupport program significantly reduced antibiotic-associated medicationerrors and ADEs as well as costs. Mullett et al designeda pediatric anti-infective decision support tool and demonstratedsignificantly fewer erroneous drug orders.

Designing and implementing effective CPOE with decision supportis more difficult in pediatrics compared with adult medicine.Because most pediatric medication dosing is weight-dependent,pediatric computer applications must allow easy updating ofa patient’s weight, a daily requirement for neonates. Similarly,normal laboratory value ranges such as creatinine vary greatly asa child matures, necessitating customized checks. These issuessuggest that computerization of ordering may be especially beneficialin pediatrics.

Computerization of the Medication Administration Record

Coupling of computerized records of medication administrationwith CPOE can eliminate many transcription errors, a commontype of medication mistake. This also allows for cumulativedose checking, which is particularly important for medicationsadministered on a per-need basis. However, few available data evaluatethe effects of computerizing this process.

Automated Dispensing

Many hospitals have used robots, which recognize medicationsusing bar codes, to automate the prescription-filling process.In one unpublished study, a robot decreased the dispensing errorrate from 2.9% to 0.6% in an adult hospital (P. E. Weaver, PharmD,unpublished data, 1998). Automating this process may be moredifficult in pediatrics because of small dosages.

Automated Drug Administration

Automated pharmacy systems featuring computer-controlled devicesthat package, dispense, distribute, and/or control medicationshave the potential to reduce administration errors. In 1969,one study documented a decrease in medication administrationerrors from 13% to 1.9% by introducing a medication profile-linkeddispensing envelope system. In 1984, Barker et al33 demonstratedthat an automated dispensing device at the bedside reduced errors,particularly errors of time and omission. This dispensing devicesounded an alert when a medication was due for administrationand restricted access to only those particular medications.In contrast, Barker and Allan demonstrated an increase inerrors with a different automated device used in the nursingunit. This device allowed nurses to obtain any medicine stored forany patient and did not integrate the computerized medicationprofiles of patients. The investigators attributed the increasein errors to nurses more commonly administering drugs from theautomated device without checking them compared with drugs takenfrom the patient’s medication drawer. This example highlightsthe importance of testing information technology interventions priorto widespread use and dissemination.

Bar coding may also reduce error rates in medication administration.Many industries use this system, resulting in error rates ofabout 1 in a million compared with 1 in 300 for keyboard entry.However, the lack of a common approach by drug manufacturersto bar coding has hindered its use in medicine. Some individualhospitals have recoded medications at a relatively modest expense.Bar coding allows rapid identification of the drug name, drugdose, and administration time as well as staff and patient names.Meyer et al demonstrated that bar coding could save 1.52 secondsper dose and improve accuracy. Easy and correct matching ofdrug to patient is particularly important in pediatrics because ofthe limited communication skills of children. A child is muchless likely than an adult to recognize an incorrect medicationintended for another patient. Concord Hospital in Concord, NH,introduced bar coding and found an 80% decrease in administrationerrors (D. DePiero, PharmD, oral communication, 2000).

Many errors occur with the delivery of intravenous medications.Smart intravenous devices are pumps that reduce the chance oferror through simplified programming and computerized checks.Such pumps are especially important for reducing the likelihoodof 10-fold overdoses, a major problem in pediatrics.

Computerized Discharge Prescriptions and Instructions

In addition to decreasing medication errors within the ambulatoryand hospital settings, information technology can bridge thesesettings to further reduce communication errors. For example,computers can generate medication instructions and prescriptionsat 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 andlaboratory data.


ERROR PREVENTION AND INFORMATION TECHNOLOGY IN THE OUTPATIENT SETTING

The issues confronting physicians ordering medications in theambulatory setting are different from those in the hospitalsetting. Computerized physician order entry with clinical decisionsupport should be equally if not more useful in the ambulatorysetting, although clinicians may prefer handheld devices fortheir mobility. Computerized transcription with direct relayof entered orders to a chosen pharmacy could further decreaseambulatory medication errors. In addition, robots might assistpharmacists in this setting.

For pediatrics, special information technology interventionsare needed at the administering stage. One unusual aspect ofthe pediatric ambulatory setting is that parents, rather thanpatients or trained nurses, administer most medications. Severalstudies have documented error-prone aspects of this process,including parental confusion regarding the correct use of teaspoons, tablespoons,and dose cups. Parents generally rely on informationfrom physicians and pharmacists regarding appropriate drug administration,yet these interactions are often rushed. World Wide Web–basedinformation on drugs could supplement verbal information, therebyconveniently educating parents who have Internet access. Ofcourse, such interventions raise issues of patient confidentialitythat must be addressed. Many children with chronic illnessessuch as asthma receive medications at school. Personalized Webpages could provide school nurses with information on a child’smedication regimen.

Parental review of a computerized medication record may furtherreduce ambulatory medication errors. Kuperman et al createdan application that allowed patients in 4 clinics to reviewpaper forms of computerized data on medication, health maintenance,and allergies. Patients added new medication data to 19% offorms, enabling physicians to address discrepancies and updatethe computerized record during their visit.


PREVALENCE OF EXISTING TECHNOLOGY

Few data exist regarding the prevalence of information technologyinterventions, although it appears that less than 5% of US hospitalscurrently have CPOE in place. One pediatric hospital thathas implemented this technology is the Alfred I. duPont Hospitalfor Children in Wilmington, Del (S. Levine, PharmD, oral communication,2000). Among the approximately 230 hospital-based robots presentlybeing used, 3 of these are in freestanding pediatric institutions(P. Pierpaoli, MS, oral communication, 2000). The Departmentof Veterans Affairs hospitals are presently adopting bar coding.In addition, at least 11 medical technology firms currentlyoffer 19 different automated pharmacy systems, and 55% of hospitalsuse such devices.


FUTURE AGENDA FOR INFORMATION TECHNOLOGY AND PEDIATRIC PATIENT SAFETY

Although only limited data are available, it appears likelythat medication errors are a major problem in children’s healthcare today. Information technology, especially CPOE with clinicaldecision support, is a powerful tool that has already provedto decrease medication errors. However, the development of pediatric-specificinformation technology is essential.

The first step in a pediatric patient safety and informationtechnology research agenda is a more rigorous determinationof the epidemiology of iatrogenic injuries in children. Furtherstudies need to examine nosocomial infections, operative complications,diagnostic mishaps, and medication errors. These epidemiologicalstudies are necessary for 2 reasons: (1) root cause analysis oferrors allows for informed innovation and application of informationtechnology interventions; and (2) determination of error ratesallows an accurate baseline against which to measure the effectsof interventions from both the patient safety and economic perspectives.

Once researchers more clearly define the epidemiology of iatrogenic injuryin children, they must develop pediatric-specific interventions.The next and perhaps most important step will be applicationand testing; some interventions can actually increase the ratesof medication errors.33 In contrast, appropriately designedand implemented information technology interventions can reduceerrors by organizing information in a timely manner, identifyinglinks between pieces of information, and doing repetitive tasks.Careful testing also allows prioritization, which is valuable becauseof the limited available resources.

The final step will be dissemination of interventions. Thisstep is critical in pediatrics, where creating technology interventionsis specialized, costly, and time-consuming. The ultimate goalis to create systems that allow people to spend more time oncomplex decisions by reducing menial tasks through informationtechnology.

What This Study Adds

Medication errors and ADEs are common, costly, and injuriousto patients. It is important to implement strategies to decreaseerrors. This paper reviews the role of information technologyin decreasing pediatric medication errors in both inpatientand outpatient settings.

Information technology interventions have great potential forreducing the frequency of errors. The magnitude of benefitsmay be even greater in pediatrics than in adult medicine becauseof the need for weight-based dosing. Further development, application,evaluation, and dissemination of pediatric-specific informationtechnology interventions are essential.

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