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Pediatrics
August 2014, VOLUME 134 / ISSUE 2
Review Article

Interventions to Reduce Pediatric Medication Errors: A Systematic Review

Michael L. Rinke, David G. Bundy, Christina A. Velasquez, Sandesh Rao, Yasmin Zerhouni, Katie Lobner, Jaime F. Blanck, Marlene R. Miller

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Abstract

BACKGROUND AND OBJECTIVE: Medication errors cause appreciable morbidity and mortality in children. The objective was to determine the effectiveness of interventions to reduce pediatric medication errors, identify gaps in the literature, and perform meta-analyses on comparable studies.

METHODS: Relevant studies were identified from searches of PubMed, Embase, Scopus, Web of Science, the Cochrane Library, and the Cumulative Index to Nursing Allied Health Literature and previous systematic reviews. Inclusion criteria were peer-reviewed original data in any language testing an intervention to reduce medication errors in children. Abstract and full-text article review were conducted by 2 independent authors with sequential data extraction.

RESULTS: A total of 274 full-text articles were reviewed and 63 were included. Only 1% of studies were conducted at community hospitals, 11% were conducted in ambulatory populations, 10% reported preventable adverse drug events, 10% examined administering errors, 3% examined dispensing errors, and none reported cost-effectiveness data, suggesting persistent research gaps. Variation existed in the methods, definitions, outcomes, and rate denominators for all studies; and many showed an appreciable risk of bias. Although 26 studies (41%) involved computerized provider order entry, a meta-analysis was not performed because of methodologic heterogeneity. Studies of computerized provider order entry with clinical decision support compared with studies without clinical decision support reported a 36% to 87% reduction in prescribing errors; studies of preprinted order sheets revealed a 27% to 82% reduction in prescribing errors.

CONCLUSIONS: Pediatric medication errors can be reduced, although our understanding of optimal interventions remains hampered. Research should focus on understudied areas, use standardized definitions and outcomes, and evaluate cost-effectiveness.

  • Abbreviations:
    ADE —
    adverse drug event
    CDS —
    clinical decision support
    CPOE —
    computerized provider order entry
    CINAHL —
    Cumulative Index to Nursing and Allied Health Literature
    ISMP —
    Institute for Safe Medication Practices

    • Medication errors are common in pediatric patients; 5% to 27% of all pediatric medication orders result in a medication error.1–3 Medication errors cause significant mortality and morbidity, including 7000 patient deaths annually from medication errors in the United States.4,5 Pediatric inpatients may have 3 times more medication errors than adult inpatients, and these errors are frequently harmful.2 For children, 1% of all medication errors carry significant potential for harm, with 0.24% of errors causing actual harm.2 Children are at high risk for these errors6 due in part to the need for weight-based dosing.7,8

    To reduce this preventable harm, pediatric health systems, institutions, and providers must understand, implement, and augment interventions to reduce pediatric medication errors.9 Previous systematic reviews on pediatric medication error epidemiology or specific pediatric medication error intervention subsets,10–20 including 1 review by our group,10 found appreciable variation in medication error definitions, populations, and outcomes, precluding true synthesis of data. All previous systematic reviews looking at interventions to reduce pediatric medication errors examined subsets of interventions only,11–18 and all searches in epidemiologic or intervention reviews were performed before 2008,10,11,13–18 except 1 that examined nurse staffing interventions performed in 2010.12

    The large increase in quality improvement intervention publications in the 6 years after our previous review,10,21 the lack of a systematic review looking at all interventions to reduce pediatric medication errors, and the hypothesis that newer publications might use consistent definitions and outcomes allowing quantitative data synthesis suggest an updated systematic review on interventions to reduce pediatric medication errors is warranted. By using rigorous systematic review methodology, we aimed to determine the effectiveness of interventions to reduce pediatric medication errors, identify persistent gaps in the pediatric medication error reduction literature, and perform meta-analysis on comparable studies.

    Methods

    Search Strategy

    The authors searched PubMed, Embase, Scopus, Web of Science, Cochrane Library, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) for studies investigating interventions to reduce pediatric medication errors (Supplemental Information). The search included a pediatric concept and a medication error concept. Terms were searched as controlled vocabulary in applicable databases (PubMed, Embase, CINAHL, Cochrane) and as keywords in all databases. The search was run as an update to a previous literature review,10 with the previous search strategy broadened to ensure complete article retrieval (Supplemental Information). The date parameters were limited from 2005 to the search date to capture literature published since the first review. Performing a complete search on all dates was beyond the scope of available resources. All searches were conducted on November 22, 2011. Articles included in previous systematic reviews on pediatric medication errors10–20 were also included in the full-text review to augment our previous review and to ensure all relevant articles published before 2005 were retrieved.

    Eligibility Criteria

    The study types for this review included randomized controlled trials, quasi-randomized controlled trials, controlled before and after trials, and interrupted time-series studies published in any language and in any country. An intervention was defined as anything aimed at reducing medication errors. Computerized provider order entry (CPOE) was defined broadly as any electronic system that facilitates medication prescribing.14 Clinical decision support (CDS) for CPOE was also defined broadly as any system that prompts users on correct dosages, alerted prescribers when dosages were out of prespecified ranges, or alerted drug-drug interactions.11,14 Preprinted order sheets were broadly defined as any structured, paper-based form that prompted or required providers to enter specific medication-ordering information. Comparator groups were broadly defined by the included articles, but studies without a clear comparator group were excluded. For example, a study reporting errors discovered by pharmacist medication reconciliation but not reporting how many errors occurred without pharmacist medication reconciliation would be excluded. Studies had to include subjects <19 years of age in any care setting. Inpatients were defined as admitted patients not solely in the ICU, ambulatory patients were patients not admitted and excluding emergency department patients, and emergency department patients were patients seen in the emergency department, whether or not they were eventually admitted.

    To capture the broadest possible range of definitions, the outcome of interest was medication errors as defined by the National Coordinating Council for Medication Error Reporting and Prevention: “A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.”22 Secondary outcomes included (1) preventable adverse drug events (ADEs; preventable errors that reached a patient and resulted in harm as defined by the Institute for Safe Medication Practices [ISMP] categories 5, 6, or 7 [significant temporary harm, permanent harm, near death or death])23 and (2) serious preventable ADEs including ISMP categories 6 or 7 only (permanent harm, near death or death).23 Studies using voluntary error reports as their outcome (numerator or denominator) were excluded because voluntary error reports may underestimate the true incidence of medication errors; it is also difficult to interpret true denominators for these interventions.21,24 “Orders” were defined as inpatient medication prescribing, and “prescriptions” were defined as ambulatory medication prescribing. We excluded studies conducted in simulation settings only (eg, nurses administered medications to a mannequin) because of concern that they did not represent real-world efficacy. Studies designed solely to change the volume of prescribing were also excluded.

    Abstracts from conference presentations and full-text articles were included. All authors of abstracts included in the systematic review were contacted for additional information (n = 3), and 2 responded.

    Data Abstraction and Study Quality Assessment

    Two independent, nonblinded authors (M.L.R. and C.A.V., S.R., or Y.Z.) reviewed each title and abstract for inclusion. Full-text review was also conducted by 2 independent, nonblinded authors (M.L.R. and C.A.V., S.R., or Y.Z.) and discrepancies were resolved through author consensus discussions. Both abstract reviews and full-text reviews were piloted on sample abstracts or articles respectively, to ensure reviewer consistency in judging inclusion criteria. For non–English-language studies included in the full-text review (n = 13), independent reviewers with fluency in the article’s language translated and abstracted data from the article. To ensure accurate translations, the primary author (M.L.R) independently translated all foreign-language articles with computer translation software, previously shown to be effective for systematic reviews.25 As above, 2 authors made inclusion decisions for non–English-language studies based on translations.

    Using identical methodology as our previous review,10 data abstraction for included articles was conducted in sequential fashion, as the second abstractor (M.L.R.) was able to see the first reviewer’s or translator’s abstracted data. Data abstraction was conducted via an electronic abstraction form, which was pilot tested for consistency among reviewers (Supplemental Fig 3). When data were unclear or missing, the corresponding author was contacted via e-mail at least twice. In addition to collecting the standard systematic review data points of population, intervention, and outcomes, we also abstracted data on quality improvement markers.26 We selected the following markers to help assess whether studies used robust quality improvement methodologies: sustainability (number of months that data were collected after beginning the intervention), cost of intervention, patient or family involvement at any point in the design, conduct or interpretation of the study, and target population acceptance of the intervention (defined as any qualitative or quantitative assessment of feedback from the participants at whom the intervention was directed).

    To assess article quality, 2 independent reviewers (M.L.R. and C.A.V., S.R., or Y.Z.) used the Cochrane Effective Practice and Organization of Care Review Group guidelines.27 Individual article potential bias from funding sources and aggregate article publication bias (the number of studies published with positive and negative findings) were also assessed. Finally, study rigor was assessed by examining if a second person verified that medication errors met error definitions stated in the manuscript. This was done because reviewer discrepancies often exist in determining whether a medication error is truly an error.28

    Synthesis of Results and Statistical Analysis

    Outcomes were expressed as the number of medication errors, defined by the articles’ authors, per 100 events observed, also defined by the articles' authors. Events observed included orders, medication administration opportunities (administered doses and omitted doses), patients, patient days, admissions, prescriptions, and medication days (a prescribed medication that is continued during a day and leads to an administration). Clinical and methodologic heterogeneity was assessed by examining potential variations in primary and secondary outcomes (error definitions), interventions, study populations, and settings. A random-effects meta-analytic model was used given the heterogeneity of included studies and the nonstandardization of study medication error definitions. For CPOE studies, we hypothesized that there was sufficient homogeneity in subsets of studies (CPOE with CDS versus manual order entry, CPOE with CDS versus CPOE, CPOE with CDS versus manual order entry in PICUs, CPOE with CDS for continuous infusions versus manual order entry) to aggregate outcome statistics. The I2 statistic was used to calculate the degree of heterogeneity for meta-analysis. As noted below, the I2 statistic was >80% for each subset, suggesting that studies were too heterogeneous for meta-analysis.

    Results

    Search Results

    Our search identified 6246 abstracts composed of 3788 unique abstracts. A total of 3588 abstracts were excluded during abstract review. An additional 74 articles from previous systematic reviews were identified for full-text review.10–20 A total of 274 articles were included in full-text review, and of these, 63 were deemed eligible for inclusion in the systematic review (Fig 1).1,29–91 Ten articles (16%) were included from previous systematic reviews, and 53 (84%) were identified by the current search protocol. The most common reason for exclusion in the full-text review was articles discussing strategies to reduce medication errors without data that met inclusion criteria (n = 77). Of these 77 studies, 29 were excluded for using voluntary error reports only, 27 had no preintervention or during-intervention comparator group, 13 discussed qualitative outcomes only, and 8 were excluded for other reasons. A summary of all articles included in this study is presented in Table 1.

    FIGURE 1
    FIGURE 1

    Summary of search and screening process.

    View this table:
    TABLE 1

    Summary of Article Characteristics and Results by Primary Intervention

    Aggregate Data Synthesis

    Most studies were conducted in the United States (51%) and in a single site (95%) that was academic/university-affiliated (90%). Nine studies (14%) included emergency department patients and 7 (11%) included ambulatory patients. Twenty-six studies (41%) investigated the effects of CPOE on medication errors (22 investigated CPOE and CDS and 4 investigated CPOE without CDS), 20 studies (32%) investigated the effects of education, 9 (14%) investigated the effects of preprinted order sheets, 8 (13%) investigated the effects of protocol implementation, 7 (11%) investigated the effects of publicizing/reporting error rates, and 5 (8%) investigated the effects of increased pharmacist participation in medication ordering. Additional interventions are described in Table 2. Only 6 studies (10%) investigated solely administering errors and 2 (3%) investigated solely dispensing errors. Twelve articles (19%) assessed severity of errors by using variations on “no harm, minor harm, severe harm, or death,” with a wide variation in the number of severity categories from 2 to 11 (mean: 3.7). Wide variation also existed in the denominator used for outcome rates (Table 2).

    View this table:
    TABLE 2

    Aggregate Data Synthesis for 63 Included Studies

    With regard to our secondary outcomes, 6 studies (10%) reported preventable ADEs and no studies reported serious preventable ADEs. Of the studies reporting preventable ADEs,1,40,45,62,66,73 2 studies1,45 reported statistically significant decreases in ADEs after an intervention: a 77% reduction in preventable ADE prescribing errors using multiple error reduction strategies (n = 16 of 12 026 pre versus 3 of 9187 post) and a 43% reduction in all types of preventable ADE errors using CPOE with CDS (n = 46 of 1197 pre versus 26 of 1210 post), respectively. Two of the other studies40,66 reported only 1 preventable ADE during their respective pre- and postintervention periods, and a third study62 reported 2 preventable ADEs, 1 during the pre- and 1 during the postintervention periods.

    With regard to the robustness of quality improvement methodology, only 10 studies (16%) reported whether their intervention was accepted by the target population and 5 studies (8%) involved patients or families at any point in the design, conduct, or interpretation of the study. Sixteen studies (25%) collected data for ≤3 months after implementing the intervention.

    There was an appreciable risk of bias in most studies (Fig 2), with, for example, 67% of the 52 interrupted time-series studies not protecting against secular changes. Sixty studies (95%) reported positive results for their intervention, suggesting possible publication bias. Thirty-four of those studies reported statistically significant positive results, 7 reported non–statistically significant results (P > .05), and 19 did not report statistical inferences for the outcome of interest. Of the 3 studies included that did not report positive results for their intervention, 2 reported non–statistically significant results. Thirty-seven studies (59%) did not report funding sources for their research, and four of those who did (6%) had a potential conflict of interest. In 27 studies (43%), no one verified that the errors collected were truly errors, and in 9 additional studies (14%) it was unclear if someone verified errors.

    FIGURE 2

    Risk of bias of studies by type of trial. A, Interrupted time-series studies (52 studies). B, Controlled before/after studies (8 studies). C, Randomized controlled trials (3 studies). Article quality was assessed with the Cochrane Effective Practice and Organization of Care Review Group guidelines,27 and sample definitions of criteria above can be found on their Web site or on the data collection sheets in Supplemental Fig 3.

    Data Synthesis for Specific Interventions

    Of the 63 studies included, 52 (83%) were able to be included in qualitative data synthesis for a specific intervention: 26 for CPOE, 14 for education, 9 for preprinted order sheets, and 5 for increased pharmacist participation in drug therapy. One study1 evaluated both preprinted order sheets and increased pharmacist preparation, and 1 study77 evaluated both CPOE and preprinted order sheets. Although summary ranges are presented below, appreciable heterogeneity still exists between many studies using the same intervention. All other intervention subsets (protocol implementation, publicizing/reporting error rates, double checking, environmental changes, unit drug dose distribution system, non-CPOE technology for medication administration) were too heterogeneous for synthesis (Table 3).

    View this table:
    TABLE 3

    Qualitative Synthesis for Selected Intervention Subsets

    Of the 26 CPOE interventions, 4 investigated the effects of CPOE without CDS compared with manual order entry33,74,77,79 and reported a 44% to 88% reduction in prescribing errors. Five studies examined the effect of CPOE with CDS for multiple medications on inpatients45,46,51,73,88 and found a 14% increase in errors to a 99% decrease in all types of errors. The study reporting a 14% increase in all types medication errors73 noted that this change was non–statistically significant (P > .05) and also reported a statistically significant 7% decrease in nonintercepted, serious medication errors. Ginzburg et al43 and Kirk et al54 looked at ambulatory prescribing errors for acetaminophen or ibuprofen and reported a 36% reduction (n = 103 of 316 pre vs 46 of 224 post) and an adjusted risk of 56% (n = 534 of 1893 pre vs 299 of 2381 post) in these types of prescribing errors, respectively. When applying meta-analytic models, I2 statistics for each CPOE subset were >80%. On the basis of criteria in the Cochrane Handbook for Systematic Reviews of Interventions,92 this finding suggests large heterogeneity and therefore meta-analysis results are not presented.

    Although 20 studies reported provider education as part of their intervention to reduce pediatric medication errors, 14 studies31,34,37,40,56,60,65,71,75,76,78,82,85,87 used education as their main intervention to reduce pediatric medication errors. Seven of these 14 studies collected data for ≤3 months after implementing the intervention and 2 did not report on the months of observation after implementation. The 5 studies that collected data for >3 months after implementing the intervention37,60,65,71,85 reported a 49% to 87% reduction in any type of medication error.

    The 9 studies that investigated the effectiveness of preprinted order sheets in reducing pediatric medication errors1,30,32,35,39,55,57,68,77 reported a 27% to 82% reduction in prescribing errors. Of the 5 studies investigating increased pharmacist participation in drug therapy1,42,50,64,89, 4 reported a 17% to 50% decrease in medication errors. The fifth article89 reported a 16% increase (n = 389 of 856 pre versus 280 of 540 post) in administering errors after the intervention but investigated the impact of opening a satellite pharmacy; although we assume that closer proximity of pharmacists led to increased involvement in the prescribing/administering process, it was unclear whether this was the case and therefore this article may not be comparable to the others.

    Discussion

    In this systematic review of all types of interventions to reduce pediatric medication errors, multiple interventions revealed statistically significant effects. Unfortunately, appreciable gaps in the pediatric medication error literature were identified: no studies that met inclusion criteria investigated the effects of medication reconciliation, only 1% of studies were conducted at community hospitals, 11% of studies were conducted in ambulatory populations, 10% of studies reported preventable ADEs, 10% of studies examined administering errors, 3% of studies examined dispensing errors, and appreciable variation existed in the methods, definitions, outcomes, and rate denominators. No study reported outcomes using a standard definition of serious preventable ADEs. Although 41% of studies involved some version of CPOE, a meta-analysis could not be performed because of methodologic heterogeneity. Despite a large increase in the number of published studies aiming to reduce pediatric medication errors since 2005,10 our knowledge of interventions to prevent pediatric medication errors remains hampered by nonuniform definitions, nonuniform data collection methodology, and nonuniform outcome reporting. The heterogeneity in current pediatric medication error intervention studies prevents wide generalizability of results and yields unclear guidance to hospitals on which interventions are best to adopt.

    Interestingly, studies implementing CPOE and those implementing preprinted order sheets reported similar reductions in medication errors despite vastly different cost levels.93 CPOE with CDS studies43,51,54,69,90 reported a 36% to 87% reduction in prescribing errors when compared with CPOE without CDS. Preprinted order sheet studies reported a 27% to 82% reduction in prescribing errors,1,30,32,35,39,55,57,68,77 when compared with manual order entry, a condition comparable to CPOE with versus without CDS. Of CPOE studies that looked at the broadest range of patients and outcomes, Holdsworth et al45 and Trotter and Maier88 reported reductions in error rates, whereas Walsh et al73 reported a non–statistically significant increase in all-cause medication errors. Kadmon et al47 and Potts et al67 looked at CPOE with CDS for all medications in PICU settings and reported significant reductions in prescribing errors (88% and 95%, respectively), whereas Algaha et al30 and Burmester et al35 also reported significant reductions in errors for all medications using preprinted order sheets in PICU settings (53% and 76%, respectively). Comparable outcomes between CPOE and preprinted order sheets could imply that resource-constrained settings may wisely focus on implementing integrated care pathways and preprinted order sheets if CPOE with CDS is deemed too expensive despite national efforts to incentivize its implementation.94 These conclusions are limited by the heterogeneous nature of outcomes and definitions in these studies, which likely contributes to the wide range of outcomes. The authors would recommend investigating each relevant study (Table 1) to clearly understand its applicability and context before drawing policy-level conclusions.

    In 2001, the ISMP published guidelines for preventing medication errors in pediatrics9 that recommended CPOE, barcoding technology, unit dose-dispensing systems, and educational systems for all providers. More than a decade later, we are unable to find bias-free, robust, and rigorous evidence in the literature to support these recommendations for children. Clearly, not all interventions require randomized controlled trials before implementation, but it is integral in current resource-constrained environments to identify interventions with maximum return on investment both in terms of dollars and, more importantly, patient lives. Future research should focus on determining the reduction in medication errors compared with the investment in resources and time required for an intervention’s implementation, because institutions are faced with multiple potential interventions to reduce medication errors. Applicability and efficacy of interventions in non–university-affiliated and/or developing countries are also prime areas for future study because 90% of studies were conducted at academic/university-affiliated medical centers and 88% of studies were conducted in North America or Europe.

    One of the first steps in remedying the gaps identified in this study is the standardization of definitions and research methodologies for medication error studies. Universal adoption of the National Coordinating Council for Medication Error Reporting and Prevention guidelines22 for grading medication errors would permit providers to know if an intervention prevents not only medication errors but also harmful medication errors. Additionally, consistent denominators for medication error rates that reflect the total opportunities for error in each category would allow for better comparisons across studies and sites: prescribing errors per 1000 orders or prescriptions, administering errors per 1000 opportunities for medication administration, and dispensing errors per 1000 medications dispensed.93 Although patient days and patients are often easier denominators to collect, they prevent comparisons between studies because it is unclear if patients in tertiary care centers are sicker, have more medications ordered, and therefore are at greater risk for a medication error. The universal use of the SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting,26 although challenging to implement in its entirety, would allow readers to understand the complete quality improvement process for each intervention and increase the spread of effective studies. Finally, inclusion of cost analysis and return on investment figures in intervention studies, which is difficult in locally funded quality improvement projects, could allow policy makers and medical leaders to weigh the costs and benefits of possible interventions before choosing which of the many potential medication error interventions to implement.

    Implementing these suggestions in pediatric medication error research remains challenging. We appreciate that not all quality improvement research projects can meet every metric regarding high-quality, bias-free studies as laid out by the Cochrane Effective Practice and Organization of Care Review Group guidelines.27 Recognizing these challenges, front-line quality improvement experts would benefit from training in both quality improvement and scientific methodology to produce more impactful research. Furthermore, increased collaboration between front-line clinicians looking to improve practices and trained clinical researchers would aid in the quality and quantity of medication error research, and protect patients from these harmful errors. Finally, given the small sample size problem frequently encountered when researching pediatric patients, medication error reduction collaboratives, with larger groups of pediatric patients to study and more pediatric centers sharing resources, could make a larger impact on both medication error science and harm prevention.

    Conclusions

    Pediatric medication errors can be reduced through multiple interventions aimed at improving the medication process. More research is needed in the areas of ambulatory patients, nondeveloped countries, administering and dispensing errors, and community hospitals and should use standardized definitions for medication errors and outcomes. Additional cost-effectiveness data on interventions to reduce pediatric medication errors would benefit policy makers and medical leaders as they choose between multiple possible interventions. Reducing medication errors presents an important opportunity for improving the quality and diversity of current research.

    Footnotes

      • Accepted May 7, 2014.
    • Address correspondence to Michael L. Rinke, MD, PhD, Children’s Hospital at Montefiore, 3415 Bainbridge Ave, Bronx, NY 10467. E-mail: mrinke{at}montefiore.org

    • This statement attests that all of the above listed authors contributed significantly to the (1) conception and design, acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; and (3) final approval of the version to be published. All authors agree to be accountable for all aspects of the work.

    • Dr Rinke conceptualized and designed the study, participated in data acquisition, led data analyses, and drafted the initial manuscript; Drs Bundy and Miller assisted in design of the study, participated in data analyses and interpretation of data, and reviewed and revised the manuscript; Drs Velasquez, Rao, and Zerhouni assisted in the design of the study, participated in data acquisition and data analyses, and reviewed and revised the manuscript; Ms Lobner and Ms. Blanck assisted in the design of the study, participated in data acquisition, and reviewed and revised the manuscript; and all authors approved the final manuscript as submitted.

    • FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.

    • FUNDING: No external funding.

    • POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

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    Interventions to Reduce Pediatric Medication Errors: A Systematic Review
    Michael L. Rinke, David G. Bundy, Christina A. Velasquez, Sandesh Rao, Yasmin Zerhouni, Katie Lobner, Jaime F. Blanck, Marlene R. Miller
    Pediatrics Aug 2014, 134 (2) 338-360; DOI: 10.1542/peds.2013-3531
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