AORN Journal
Volume 85, Issue 4 , Pages 731-740, April 2007

2.2 Pediatric Medication Errors in the Postanesthesia Care Unit: Analysis of MEDMARX Data

  • Christopher H. Payne, RN

      Affiliations

    • Maj Christopher H. Payne, RN, MPA, MSN, CNOR, USAF, NC, is the interim director of surgical services and clinical coordinator of orthopedic/neurosurgical services at the 59th Medical Wing, Wilford Hall Medical Center, Lackland AFB, Tex.
    • ,
  • Christopher R. Smith, RN

      Affiliations

    • Christopher Smith, RN, MHR, MSN, CNOR, is a perioperative clinical nurse specialist at the National Naval Medical Center, Bethesda, Md.
    • ,
  • Laura E. Newkirk, RN

      Affiliations

    • LTC Laura E. Newkirk, RN, MSN, CNOR, AN, USA, is the chief of perioperative nursing services at Winn Army Community Hospital, Fort Stewart, Ga.
    • ,
  • Rodney W. Hicks, ARNP

      Affiliations

    • Rodney W. Hicks, PhD, ARNP, is the manager of patient safety research and practice for the United States Pharmacopeia Center for the Advancement of Patient Safety, Rockville, Md, and adjunct faculty, Uniformed Services University, Bethesda, Md.

Article Outline

Abstract 

•MEDICATION ERRORS involving pediatric patients in the postanesthesia care unit may occur as frequently as one in every 20 medication orders and are more likely to cause harm when compared to medication errors in the overall population.

•RESEARCHERS EXAMINED six years of records from the MEDMARX database and used consecutive nonprobability sampling and descriptive statistics to compare medication errors in the pediatric data set to those occurring in the total population data set.

•NINETEEN DIFFERENT CAUSES of error involving 28 different products were identified. The results of the study indicate that an organization can focus on causes of errors and products involved in errors to mitigate future error occurrence. AORN J 85 (April 2007) 731–740.

 

In recent years, the occurrence of medication errors and their effect on the quality of patient care delivery has received national attention. Infants and children receiving postanesthesia care are at a significant risk for medication-related errors. The results of one study indicate that it is difficult to establish the true incidence of pediatric medication errors, but they may occur as frequently as one in every 20 medication orders.1

Astute practitioners intercept the majority of medication errors in the prescription and preparation (ie, early) phases of medication processing, but because fewer checks occur later in the medication process, fewer errors are intercepted during the administration phase.2, 3 Although the incidence of medication errors in the adult population is recognized to some extent, information regarding pediatric medication errors is lacking, especially about those that occur in the postanesthesia care unit (PACU). Information is available, however, about the general nature of pediatric medication errors that describes the risk for harmful events that occur.4

This article examines the known risks of pediatric medication errors in general and summarizes information about postanesthesia medication errors involving children. For the purposes of this article, children are defined as patients younger than 17 years of age. It is important to note, however, that adolescents should not be compared to infants or toddlers. The data for this analysis was obtained from MEDMARX, an Internet-accessible medication error reporting program operated by the United States Pharmacopeia (USP).5

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Background and Significance of the Problem 

It has been suggested that medication error reporting rates are as low as 5%.6 If this is true, there is a dearth of information about the remaining 95% of errors. It is by way of medication error reporting and the knowledge gained from those reports that errors can be prevented. Health care personnel should routinely use the information gleaned from error reports involving children to improve the medication-use process. This knowledge is vital because children, particularly infants, are especially vulnerable to medication errors for a wide variety of reasons (eg, physiology, pharmacology, medication calculation).

Physiology and pharmacology. 

Pediatric patients are particularly vulnerable to medication errors because of the variation in weight, body surface, and organ maturity.7 These factors ultimately affect their ability to absorb, distribute, metabolize, and excrete medications. In addition, children have fewer physiologic reserves to buffer a medication in the event of an accidental overdose.8

Medication safety profiles typically are established using adult standards; thus, most medications are manufactured according to adult usage.7 Additionally, few medications have been involved in clinical trials with children, so most lack formal US Food and Drug Administration (FDA) licensing for use in the pediatric population.9 Clear evidence exists that sources of prescribing errors include inadequate information regarding the effects of pharmacologic agents on small children.7 The FDA estimates that more than 50% of newly approved medications each year are insufficiently tested among young children and, therefore, are not labeled for use in this population.10 The results of another report indicate that nearly 75% of medications used for children have not been studied adequately for their effects on small children, despite federal legislation to encourage pediatric trials.1 Health care providers thus have no clear indications for use and dosing guidelines.11 Potentially effective therapy may be denied to many children, or providers may decide to prescribe a medication resulting in “off-label” use.1 Although the term off-label may hold a negative connotation, it does not necessarily imply an improper procedure on the part of the prescriber. The prescriber often uses his or her knowledge of pharmacokinetics and pharmacodynamics and personal experience to use medications in an off-label manner.

Pharmacokinetics and pharmacodynamics. 

The risk of medication errors occurring in children increases because data regarding pharmacokinetics, pharmacodynamics, and toxic profiles frequently are incomplete for the pediatric population.7 Pharmacokinetics examines movement of medications through the body including absorption, distribution, metabolism, and excretion. A number of factors affecting the pharmacokinetic properties of a medication include obesity, disease processes, genetics, age, and gender of an individual. Pharmacodynamics refers to how the medication affects the individual. Cellular receptors take up the medication, which usually causes a biochemical reaction that changes the physiologic function of the cell or the cell's enzymes. Pharmacokinetic and pharmacodynamic properties vary widely for a pediatric patient. Immature hepatic, gastrointestinal, and kidney function can greatly influence a medication's bioavailability. Medications frequently are metabolized more rapidly in children than adults, but as a child's age advances toward puberty, metabolization becomes the same as that of an adult.9

Different dosage forms. 

An issue that may contribute to an error's occurrence is that products are available in many different dosage forms. Acetaminophen is an excellent example. It is available in numerous liquid concentrations,7 suppositories, and solid dosage forms as well as in combination therapies. Multiple medication formulations and off-label use are two factors that require manipulation of medication orders and may lead to dosing errors.1, 7 One FDA initiative is the Pediatric Exclusivity Provision, which entices manufacturers to perform pediatric trials by granting a six-month extension to the company's patent.11 Many medications, however, are in use before any rigorous, controlled studies can occur.4

Calculation and dosage. 

Pediatric care requires that most medication dosages be individualized based on the child's age, weight, and clinical condition.12 The necessity to use calculations to achieve weight-based dosing increases the risk for errors given variations in pediatric weights when compared to adults.7 Miscalculation of pediatric medication doses is a well-known source of iatrogenic morbidity and mortality.7, 13 The more calculations that are performed, the more opportunities there are for errors.14

There is a great deal of disparity in pediatric medication prescription, and only a few standardized dosing regimens exist. The three most familiar are weight-based, body-surface-area (BSA), and age-based dosing methods. Weight-based medication dosing is the most frequently used for pharmaceutical preparation and administration;9 however, when dosages are calculated by weight, a substantial risk for mathematical errors exists.15 Errors in medication calculation originate from many sources. The patient's weight, usually expressed in the American unit of pounds, requires conversion to a metric unit (ie, kg, gm), and the desired dose must be determined per metric unit (ie, mg/kg). The process is further complicated when manufacturers produce the product in an adult dosage form, which requires the practitioner to use partial vial contents.

If the manufacturer does not provide a recommended, weight-based dosing schedule, then the Clarke's Body Area Rule (ie, BSA in square meters multiplied by the adult dose divided by 1.73) becomes the preferred method to calculate an individual's dose.9 This method correlates well with many factors that influence pharmacokinetics and pharmacodynamics.9 Sullivan and Buchino state that

weight and body surface area can vary greatly in the pediatric population from less than 500 grams to over 100 kilograms and 0.1 to over two square meters, respectively.1(p183)

Additionally, in neonates, a fluctuation of a few grams can greatly alter required dosage.

Age-based dosing is popular for some medications, such as vaccinations, that only have pediatric indications. Most medications, however, do not come in age-based dosing increments. Regardless of the criterion used, validation of a patient's weight, BSA, or age is imperative depending on the dosing criterion used.

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Methods 

The USP allowed perioperative clinical nurse specialist (CNS) students from the Uniformed Services University of the Health Sciences, Bethesda, Md, to access pediatric medication error data from MEDMARX for pediatric errors originating in the PACU. The perioperative CNS students provided data analysis, clinical interpretation of the medication error events, and implications for practice. They used Crystal Reports 9.016 and structured query language to identify pediatric medication errors originating in the PACU during a six-year time period from Sept 1, 1998, to Aug 31, 2004. Consecutive nonprobability sampling17 was used to obtain the sample, which included all medication error records containing at least one product. The data set was analyzed using descriptive statistics.

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Findings 

Three variables regarding the general nature of pediatric medication errors occurring in the PACU were determined in each medication error record: severity of the error, cause of the error, and the product(s) involved. The errors occurred somewhere along the continuum of care from prescription to administration.

Severity of errors. 

Between Sept 1, 1998, and Aug 31, 2004, 42 hospitals reported 59 medication errors involving children in the PACU, of which 12 (20%) were harmful. During the same time period, 354 institutions reported 2,406 medication errors in the PACU. Of these errors approximately 6% (146) were harmful. The records identified 19 different causes of error and were associated with 28 different products.

Cause of errors. 

The five leading causes of pediatric medication errors were performance deficit, procedure/protocol not followed, knowledge deficit, calculation errors, and lack of communication. Performance deficit (ie, the person involved in the error had the requisite skills and knowledge to safely discharge his or her duties but failed to do so in this instance18) accounted for the vast majority of causes of error in both the pediatric (51%) and overall (42%) populations. Procedure/protocol not followed was nearly equivalent in both populations (ie, 28% pediatric, 26% overall) as was communication (ie, 16% pediatric, 15% overall). Knowledge deficit (ie, the practitioner had insufficient knowledge about the product) was higher in the pediatric population (ie, 18% pediatric, 12% overall). Errors involving calculations, decimal points, and dosage form confusion, which are all math related, were reported in higher percentages in the pediatric population compared to the overall population (Table 1).

Table 1. Causes of Pediatric Medication Errors Compared to Medication Errors in the Overall Population*
Cause of ErrorPediatric (%)Overall (%)
Performance deficit5142
Procedure/protocol not followed2826
Knowledge deficit1812
Calculation error163
Communication1615
Decimal point placement50.7
Dosage form confusion**52

* Percentage may not equal 100 because more than one cause may have been identified.

** Two solid forms were available (ie, immediate release and sustained release).

Products. 

Twenty-eight different products were involved in pediatric medication errors (Table 2). Four medications

•morphine (ie, 20%);

•acetaminophen (ie, 13%);

•meperidine (ie, 9%); and

•fentanyl (ie, 6%)

Table 2. Products Involved in Pediatric Medication Errors Compared to Medication Errors in the Overall Population
Products involved in errorsPediatric (%)Overall (%)
Morphine2018
Acetaminophen131
Meperidine97
Fentanyl64
Acetaminophen and codeine50
Cefazolin56
Ampicillin and sulbactam31
Dextrose 5% in water and lactated Ringer's (LR) solution30
Diphenhydramine30
Ketorolac35
LR solution31
Albuterol20
Amoxicillin20
Bupivacaine21
Dexamethasone21
Docusate sodium20
Droperidol20
Hydralazine20
Meclizine20
Metoclopramide21
Metronidazole21
Milrinone20
Oxycodone and acetaminophen22
Penicillin G potassium20
Potassium phosphate20
Promethazine22
Thiopental20
Vancomycin21

were implicated in nearly half (ie, 48%) of the errors. Table 3 presents medications involved in medication errors that resulted in harm to the patient. The products involved in pediatric errors are similar to those found in the overall population except for acetaminophen, which was higher in pediatric errors than overall. These 28 different products represent about 10% of the 301 unique products seen in the overall data set.

Table 3. Products Involved in Harmful Pediatric Medication Errors in the Postanesthesia Care Unit
Products involved in errorsPercentage
Morphine55%
Meperidine18%
Hydralazine9%
Metoclopramide9%
Vancomycin9%

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Discussion 

The MEDMARX data affirm that medication errors involving children do occur during postanesthesia care, and these errors often result in patient harm. Although the sample size is relatively small compared to errors overall, the data begin to point to areas where quality improvement efforts could be focused. We examined only three variables from the MEDMARX program (ie, error severity, cause of error, products associated with the error) and offered a comparative view of all medication errors in the PACU during the same time period.

Error severity. 

The large percentage of harmful pediatric medication errors in the PACU (ie, 20%) is troublesome, especially in the context of overall harmful PACU errors (ie, 6%) and in the context of what USP has published annually (ie, approximately 1.5%) for all clinical locations. Given this disparity, health care facilities must begin to examine the nature of these events in order to better understand the risks and to design interventions that reduce harm.

Causes of error. 

Nineteen different causes of error were identified, which can be grouped into three categories—problems with policies and procedures, dosing errors, and communication. Focusing on the causes of errors will help health care facilities mitigate future error occurrence.

The results of this study indicate that the percentage of error occurrence related to policies and procedures involving pediatric patients compared to the overall population were almost equivalent. This finding suggests that institutions may wish to further explore why policies and procedures are not being followed to the maximum extent possible. Policies should be readily available, easy to understand, and directly applicable to all situations. Administrators and staff members should review medication administration policies periodically to ensure that they provide adequate guidance.

Errors in calculating pediatric medication doses are a well-recognized cause of iatrogenic morbidity and mortality, and this finding is not surprising given the dearth of literature available on the topic. For example, in a systematic review of the literature, one study explored the causes that led to dosing errors and concluded that calculation errors cause numerous 10-fold to 100-fold overdoses.12 The errors either were the result of misplacement of the decimal point or mathematical errors during the calculation process.

•In the MEDMARX data, incorrect decimal-point placement was the largest contributor (ie, 50%) to harmful pediatric medication errors in the PACU. Decimal-point errors often are implicated in causing a 10-fold increase in medication delivery.7 One study found that 60% of dosage errors occurred with decimal-point placement, calculations, or expression of the dosage regimen (eg, morphine 0.1 mg/kg IM every three to four hours as needed for pain).19 According to another study, decimal-point misplacement occurred in nearly 30% of reported pediatric medication errors.15 The MEDMARX data suggest that many of the medication errors are a result of decimal errors, which occur infrequently; however, when compared to overall cases as a percentage (ie, 0.7%), a seven-fold increase in decimal-point errors occurred in the pediatric population (ie, 5.3%).Decimal errors occur both in writing and interpreting prescriptions. Misinterpreting decimal-point placement is common in handwritten prescriptions or medication orders. For example, when a .2 mg dose is ordered, the decimal point might be overlooked and the order interpreted as 2 mg. In this example, a leading zero would clearly define the dosage (ie, 0.2 mg). Another example is 2.0 mg, which if the decimal point is not noticed could be misinterpreted as 20 mg. This example shows the inappropriate use of a trailing zero, which also can cause confusion. These examples could result in a 10-fold variance in the desired dose.

•Clearly, mathematics-related medication errors continue to cause morbidity and mortality among the pediatric population. The MEDMARX data suggest that many of the medication errors are a result of miscalculations.Data from one study indicate that 17.5% of errors involve some version of a miscalculation.20 This finding was supported by another study involving medication errors with infants in which miscalculations were a common cause of error.21 Other researchers tested pediatric residents' medication dose calculation skills with a 10-prescription quiz and found that the majority made calculation errors.13 One group of authors suggests that assessment of the math competency of nurses, physicians, and pharmacists should occur periodically to reduce the risk of medication error.1 The same authors suggest that using preprinted order forms or computerized physician order entry would eliminate the need for manual calculations and further reduce medication errors.

Although it is difficult to define the concept of communication, it is an important component in the pediatric medication-use process. According to Joint Commission sentinel event statistics from 1995 to 2004, poor communication was the leading cause of medication errors, closely followed by lack of orientation and training, with both greater than 60%.22 Although MEDMARX data confirm that communication was a cause of pediatric medication errors in the PACU, it is not much greater than in the overall population (ie, 16% and 15% respectively). Communication between the pharmacist, physician, nurse, and patient is not only essential but invaluable. Researchers who have studied the communication that occurs between nurses and physicians have reported that improved communication can lead to an improvement in patient safety. One study showed that an increase in nurse-physician collaboration was associated with improved patient outcomes,23 and another author found that open communication could enhance collaboration and reduce errors.24 Additionally, in a 2003 study, 10 medication error prevention strategies were analyzed for their potential in the reduction of overall and potentially harmful error rates. The researchers asserted that by improving communication between physicians and pharmacists, 47% of errors could be avoided.14

Error-prone products in the PACU. 

Most medications have a narrow therapeutic range for the pediatric population, and doses outside that range often are associated with increased occurrence of morbidity and mortality.1 Morphine, meperidine, and fentanyl were collectively involved in 35% of PACU pediatric medication errors (ie, 20%, 9%, and 6%, respectively) compared to 29% of errors in the overall population.

•Two opioid products were implicated in 73% of the harmful pediatric errors in this study (ie, morphine [55%], meperidine [18%]) and are worthy of discussion. Fully one-half of these harmful errors occurred as a result of calculation errors or misplacement of the decimal point. Institutions most often obtain these products in usual adult-dosage formulations, and practitioners must perform serial calculations to determine the final desired dosage. Several of the errors reviewed were the result of confusion between dose and volume expressions (ie, 0.1 mg versus 0.1 mL).

•Acetaminophen and its combination products were implicated in nearly 20% of pediatric errors in the PACU. Most often, this was the result of having various dosage forms available such as liquid concentrations, suppositories, and solid dosage forms.

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Summary 

The causes of medication errors are multifactorial, and errors can occur anywhere along the continuum from prescription to administration. Total elimination of medication errors in the current health care system is highly unlikely. Instead, health care providers, facilities, and the pharmaceutical industry must focus greater attention on identifying methods to decrease the occurrence of medication errors. Numerous organizations have published position statements, guidelines, and recommended practices to guide practitioners in safe medication administration in the pediatric population.25, 26, 27, 28, 29, 30, 31, 32 Table 4 provides a summary of these recommendations. Medication errors can be especially dangerous for pediatric patients, but implementing effective strategies for prevention should help reduce these errors.

Table 4. Recommendations for Safe Medication Use in the Pediatric Population1, 2, 3, 4, 5, 6, 7, 8
·Establish and maintain a pediatric formulary with policies for evaluation, usage, and selection of medications. This would provide a clear list of medications that are available along with recommendations for choice and use of the medication.

·Use one system of measurement (ie, lb versus kg) throughout the medical facility. Most medication dosing is based on milligrams per kilogram. If that is the method used in a facility, then there is no need to use measurements in pounds.

·When writing a prescription, the provider should include the weight of the child, the dose desired, and the volume of the medication.

·All providers writing prescriptions should confirm that the patient weight is accurate and that calculations are correct for weight-specific dosages.

·All providers administering medications should confirm that the patient weight is correct for weight-specific dosages.

·Establish a system that provides checks and balances throughout the medication-use process from ordering to administration. This gives all health care providers the opportunity to verify accurate dosing of the medication. Double-checking all medication calculations would be a part of this system of checks and balances.

·Write out all instructions instead of using abbreviations to eliminate any ambiguity in the order. Avoid the use of “prn” or “titrate” and give specific instructions.

·Always use a leading zero to the left of the decimal point (eg, 0.1 mg rather than .1 mg).
·Never use a terminal zero to the right of the decimal point (eg, 5 mg rather than 5.0 mg).

·Watch for look-alike/sound-alike medications. Medications that look alike or sound alike should not be stored together or near each other.

·Follow the five rights of medication administration—the right patient, the right route, the right dose, the right time, and the right medication.

·Know the antidote to each medication and ensure that it is immediately available in the right dose.

·Improve communication between physicians, pharmacists, and nurses to decrease risks of medication errors. Better communication among all the health care team members creates a system that decreases errors and enhances the working environment.

·Examine current practices to address any short-comings in the medication-use process. Any staff member should be able to address a medication safety concern for possible implementation into a safer medication-delivery system.

·Acknowledge and report medication errors without fear of reprisal. A systems approach to medication errors should take place, not pointing out who committed the error but identifying areas along the medication-use process to decrease the chance of a similar error from ever occurring again. By acknowledging that an error occurred, the facility can increase awareness of pediatric medication errors, point to those medications and departments that are at particularly high risk, and mitigate a future medication error event.

1 Patient fact sheet: 20 tips to help prevent medical errors in children. Agency for Healthcare Research and Quality. Available at: http://www.ahrq.gov/consumer/20tipkid.htm. Accessed February 26, 2007.

2 Prevention of medication errors in the pediatric inpatient setting. American Academy of Pediatrics. Available at: http://pediatrics.aappublications.org/cgi/content/full/pediatrics;102/2/428. Accessed February 26, 2007.

3 Discipline specific role in safety. Nurses: thirteen practical strategies for preventing medication errors. Jt Comm Perspect. 2003;3:7–8. Also available at: http://www.jcipatientsafety.org/fpdf/psp/PatientSafetyArticles/S4-PS-02-03.pdf. Accessed February 26, 2007.

4 Guidelines for preventing medication errors in pediatrics. The Institute of Safe Medication Practice. Available at: http://www.ismp.org/Newsletters/acutecare/articles/20020601.asp. Accessed February 26, 2007.

5 Error-avoidance recommendations for medications used in pediatric populations. The United States Pharmacopeia. Available at: http://www.usp.org/patientSafety/resources/pedRecommnds2003-01-22.html. Accessed February 26, 2007.

6 Aposition statement on safe medication administration. The American Society of PeriAnesthesia Nurses. Available at: http://www.aspan.org/PosStmtsSMA.htm. Accessed February 26, 2007.

7 Position statement: pediatric medication safety. In: Standards, Recommended Practices, and Guidelines. Denver, Colo: AORN, Inc; 2007:401–402.

8 AORN guidance statement: Safe medication practices in perioperative settings across the life span. In: Standards, Recommended Practices, and Guidelines. Denver, Colo: AORN, Inc; 2007:337–343.

The MEDMARX information revealed that calculation mistakes were five times more likely to occur in the pediatric population, and decimal-point errors, as a percentage, were seven times more likely to occur when compared to the total population. The MEDMARX data also showed that improper dose or quantity was the most frequent type of error leading to harm and was the only type of medication error that required intervention to sustain life.

Effective communication among all members of the health care team is an essential link and has been shown to reduce medication errors. This study of MEDMARX data further revealed that the opioids (ie, morphine and meperidine) caused harm in 73% of pediatric medication errors while acetaminophen and its combination of products were implicated in 20% of total pediatric medication errors. Patient safety and prevention of medication errors is a critical concern for health care providers, parents, and patients. Reducing or eliminating sources of medication errors is paramount to providing optimal pediatric health care. Perhaps most important, health care providers should remember that when caring for pediatric patients in the PACU, error reduction requires careful attention to detail.

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References 

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  27. Discipline specific role in safety. Nurses: thirteen practical strategies for preventing medication errors . Jt Comm Perspect . 2003;3:7–8 Available at: http://www.jcipatientsafety.org/fpdf/psp/PatientSafetyArticles/S4-PS-02-03.pdf Accessed February 26, 2007.
  28. Guidelines for preventing medication errors in pediatrics. The Institute of Safe Medication Practices . Available at: http://www.ismp.org/Newsletters/acutecare/articles/20020601.asp Accessed February 26, 2007.
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  indicates that continuing education contact hours are available for this activity. Earn the continuing education contact hours by reading this article and taking the examination on pages 741–742 and then completing the answer sheet and learner evaluation on pages 743–744.You also may access this article online at http://www.aornjournal.org.The authors thank COL Linda J. Wanzer, RN, MSN, CNOR, AN, USA, director, Perioperative Clinical Nurse Specialist Program, Uniformed Services University of the Health Sciences, Bethesda, Md, and Lt Col Cheryl Reilly, RN, MSN, CNOR, USAF, NC, OR element chief, Mike O'Callahan Federal Hospital, Nellis Air Force Base, Las Vegas, Nev, for their contributions to this article.Editor's notes: The opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Uniformed Services University of the Health Sciences, Department of Defense, or the United States Government.This research was partially funded by the Agency for Healthcare Research and Quality, Rockville, Md, as part of the University of North Carolina Center for Education and Research on Therapeutics (Harry Guess, CERTs PI, award number U18 HS 010397).MEDMARX is a registered trademark of the United States Pharmacopeia, Rockville, Md.

PII: S0001-2092(07)60147-1

doi:10.1016/S0001-2092(07)60147-1

AORN Journal
Volume 85, Issue 4 , Pages 731-740, April 2007

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