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Long-term Reduction in Adverse Drug Events: An

Evidence-Based Improvement Model

abstract

OBJECTIVES: To develop and test an evidence-based model for reducing medication errors and harm in hospitalized children.

METHODS: Prospective interrupted time series study evaluating the effectiveness of a multifaceted, staged intervention over 4 years in a major urban pediatric referral hospital. Guidelines for safe pediatric prescribing were implemented by using an evidence-based model. Key components included early clinician engagement and improved multidisciplinary communication, consensus development, interactive education, and timely data feedback by using iterative Plan-Do-Study-Act cycles. Impact on medication error and harm (adverse drug events, [ADEs]) was measured by using standard definitions and a multimethod approach. Prospective data from voluntary reports by nursing, medical, and pharmacy staff and intensive chart review were combined. All data were reviewed by a multidisciplinary panel, including causality assessments for ADEs.

RESULTS:Reviewed over 3 time periods were 1011 patients with 6651 medication orders. Total ADEs decreased by.50% in the first year and this was maintained at 4 years. Greatest improvements were in potential ADEs, which decreased from 12.26 per 100 patients at base-line to 4.60 per 100 patients at 4 years (P , .05). Total medication errors decreased from 4.51 per 100 orders at baseline to 2.78 per 100 orders at 4 years (P, .05). Prescribing errors decreased by 65%, from 4.07 per 100 orders at baseline to 2.05 orders at 4 years (P,.05).

CONCLUSIONS: A multifaceted, evidence-based model for safe prescribing guideline implementation, engaging multidisciplinary clinicians, was effective in reducing medication error and harm in hospitalized children, resulting in sustained long-term improvement.

Pediatrics2012;129:e1334–e1342

AUTHORS:Madlen Gazarian, MBBS (HonsI), MSc (ClinEpi), FRACP, and Linda Velta Graudins, BPharm, DHP,

GradDipClinEpid, FSHP

Paediatric Therapeutics Program, School of Women’s and Children’s Health, University of New South Wales and Sydney Children’s Hospital, Randwick, New South Wales, Australia

KEY WORDS

medication errors, drug toxicity, health care outcome and process assessment, evidence-based medicine, practice guidelines as topic, in-service training, continuing medical education, health services research, translational research, interdisciplinary communication

ABBREVIATIONS

ADE—adverse drug event

CPOE—computerized physician order entry MI—medication incident

PDSA—Plan-Do-Study-Act

Dr Gazarian has made a substantive intellectual contribution to this study, including the conception and design of the study, obtaining funding, substantial contributions to data analysis and interpretation and overall supervision of research group, preparing thefirst and subsequent drafts of the article and reviewing it critically for important intellectual content, and

final approval of the version submitted for publication; Ms Graudins has made a substantive intellectual contribution to this study, including contribution to aspects of study design, and substantial contributions to data acquisition, analysis, and interpretation, drafting segments of the article and reviewing it critically for important intellectual content, andfinal approval of the version submitted for publication.

www.pediatrics.org/cgi/doi/10.1542/peds.2011-1902

doi:10.1542/peds.2011-1902

Accepted for publication Nov 28, 2011

Dr Gazarian’s current affiliation is School of Medical Sciences, University of New South Wales, Sydney, Australia.

Ms Graudins’s current affiliation is Pharmacy Department, Alfred Hospital, Melbourne, Victoria, Australia.

Address correspondence to Madlen Gazarian, MBBS (HonsI), MSc (ClinEpi), FRACP c/o Department of Clinical Pharmacology, Therapeutics Centre, St Vincent’s Hospital and University of NSW, Darlinghurst, NSW, 2010, Sydney, Australia. E-mail: m.

[email protected]

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright © 2012 by the American Academy of Pediatrics

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

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Preventable medication errors and harm are major public health issues under intense scrutiny. Accurate esti-mates of the magnitude of these prob-lems are constrained by large variability in definitions of“error”and“harm” events and in the methods by which they are measured,1,2 which limits our understanding of their true ex-tent and nature. More importantly, this presents a major barrier to mean-ingful evaluation of the impact of pro-posed interventions and to making valid comparisons between alternative strategies to improve medication safety.

The pediatric population is a particu-larly vulnerable group at increased risk of adverse drug events.3,4Paradoxically, research relating specifically to this population is limited in its scope, with the majority of studies focused on mea-suring errors, rather than harm events, and very few evaluating potential solu-tions.1,3 Medication errors in pediatric inpatients are common, with estimates between 5% to 27% of medication orders.1 They may occur more fre-quently than in adults5and are esti-mated to have 3 times the potential to cause harm, with a substantial pro-portion of errors occurring in the pre-scribing stage.5–7

Wide-ranging recommendations for pre-venting pediatric medication errors have been made by various organizations.8,9 Close scrutiny reveals that none are based on published evidence of effec-tiveness in reducing harm in the pe-diatric population, with the majority based on expert opinion or extrapolated from studies in adults.1This paucity of evidence may reflect the difficulties of designing and conducting high-quality interventional studies in complex set-tings. Key strategies prioritized as hav-ing the greatest potential to reduce medication errors in pediatric inpa-tients include improved communication among physicians, nurses and pharma-cists; ward-based clinical pharmapharma-cists;

and computerized physician order entry (CPOE) with clinical decision support.10 The role of CPOE systems in improving safety overall remains controversial,11–13 especially in pediatric populations.14,15 Although such systems appear to re-duce the frequency of some errors, emerging evidence indicates that they can also facilitate unique errors of their own16 and, in some instances, increase harm.17,18 Such systems are very costly and currently not widely available. The special challenges of pediatric prescribing serve as addi-tional barriers to the development of effective electronic solutions suitable for pediatric use.1,19

Recent research has focused on tech-nological solutions, almost to the ex-clusion of more readily available, less costly, and possibly more effective ap-proaches. Our aim was to develop and test a multifaceted model for improving medication safety, integrating key strat-egies currently accessible to most hos-pitals, with focus on guidelines for safe pediatric prescribing derived from published recommendations8,9 and actively implemented by using an evidence-based multifaceted strategy with demonstrated effectiveness.20–22 We evaluated impact on both medica-tion errors and harm over a 4-year period by using standardized defi -nitions and a multimethod approach to error and harm measurement.

METHODS

Study Design, Setting, and Participants

This is a prospective, interrupted time-series study, evaluating the impact of a multifaceted intervention applied in stages over 4 years at a major urban tertiary pediatric hospital with 140 beds and 14 500 admissions per annum. The program was designed and led by a senior clinician (M.G.) with specialized expertise in Pediatric Clinical Phar-macology and Therapeutics, Health

Services Research, and “ Implementa-tion Science.” Table 1 gives details of evaluation periods, and Fig 1 shows the relationship between implementation and evaluation periods. Interventions involved all doctors, nurses, and phar-macists working in the hospital during the study. Evaluation was based on data collection from all inpatients in 3 rep-resentative hospital wards (excluding intensive care) over 3 time periods (baseline, 1 year and 4 years post-implementation). Evaluation occurred over 1 month at a similar time in the year to control for possible seasonal

in-fluences. The study was approved by the South Eastern Sydney Area Health Service Human Research Ethics Com-mittee.

Intervention

Because available evidence indicated prescribing errors to be the most common, these were targeted for spe-cific intervention. Local guidelines for safe pediatric prescribing (http://www. sch.edu.au/health/professionals/nimc/ nimc_safe_prescribing_guidelines.pdf ) were developed based on published ev-idence, advice from key professional organizations,8,9 and consensus of a multidisciplinary group of clinicians with expertise in pediatric medicine, nursing, pharmacy, and specialized expertise in clinical pharmacology and therapeutics (see Acknowledg-ments for members of the Improving Medication Safety in Children Project Team). We also developed separate evidence-based guidelines for para-cetamol (acetaminophen) as part of this process (Supplemental Appendix 1). Paracetamol is widely prescribed and can be associated with significant harm if used inappropriately,23so was used as a good example for contextual education about safe pediatric pre-scribing principles.

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communication, and local consensus development formed the foundation of our approach. After baseline data col-lection, a multifaceted, multidisciplinary program integrating evidence-based guideline implementation strategies with the Plan-Do-Study-Act (PDSA) model of clinical practice improvement was used20,22(Fig 1). Interventions were ap-plied in stages by using concepts from theoretical models for effective guide-lines implementation24 and knowledge

translation.25 The PDSA component of the model served as an implementation and evaluation tool, allowing tailoring of strategies to local needs, including identifying and overcoming specific barriers at different times.20

Initial stages of active implementation focused on an intensive program of interactive education (∼25 small group sessions infirst 6 months) highlighting safe prescribing principles, delivered by peer opinion leaders (predominantly

a clinical pharmacologist [M.G.] and pharmacist [L.G.] team), with emphasis on the potential for reduction in patient harm. Attendance for most was volun-tary but strongly encouraged. The guidelines were provided as handouts and available on the intranet at all times. Colorful posters (Supplemental Appendix 2) provided ready reference on all wards. Meaningful and timely data feedback was a key feature, con-tinuing throughout the program (Fig 1, PDSA cycles). Feedback occurred in face-to-face education sessions and through a quarterly therapeutics news-letter distributed to all hospital clinicians (Supplemental Appendix 3).

After thefirst year, key components of the guidelines and associated educa-tion were incorporated into routine orientation programs for all clinicians; attendance was required for all resi-dent doctors at least annually. Whereas core content remained constant, the TABLE 1 Details of Evaluation Periods and Included Patients, at Baseline, 1 y, and 4 y

Postimplementation of Safe-Prescribing Guidelines

Baseline 1 y 4 y

Total patients 359 326 326

Males, n (%) 215 (59.9) 199 (61.0) 195 (59.8)

Median age, y 2.21 2.41 2.14

[min, max] [0,16.7] [0, 17.1] [0, 17.2]

Total charts 536 513 435

Total orders 2285 2318 2048

Diagnosis category, %

Medical 66.7 61.3 66.5

Surgical 26.3 34.4 26.9

Oncology 7.0 4.3 6.4

FIGURE 1

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number and intensity of educational sessions were reduced in the second and subsequent years, as was the fre-quency of audit and feedback. Sessions were tailored to suit existing meeting times, formats, and learning needs of different clinician groups, and included addressing any identified problems after each PDSA cycle. Some education in latter stages was delivered by junior resident doctor and nurse educators, who participated in“train the trainer” type sessions and had access to a suite of supportive educational resources (latest versions accessible at http:// www.safetyandquality.gov.au/internet/ safety/publishing.nsf/content/NIMC_ 002-Paed-Educational).

During the fourth year, as part of a na-tional program, a standardized Pediat-ric National Inpatient Medication Chart (http://www.safetyandquality.gov.au/ internet/safety/publishing.nsf/content/ NIMC_010_PM-Charts) was introduced (May 2007) with accompanying edu-cation reinforcing the safe pediatric prescribing principles that had been previously disseminated as part of our implementation program. Because the investigators were also involved in the design of the national initiative, key principles in both programs were consistent and informed by evidence of effectiveness in our early post-implementation evaluation.

Evaluation

Outcomes evaluated included (1) med-ication errors (medmed-ication incidents [MIs]) and harm events (adverse drug events [ADEs]); and (2) levels of ad-herence to elements of safe pre-scribing and paracetamol guideline recommendations. Figure 2 provides definitions of medication error and harm measures and their relation-ships to each other.

Data Sources

Prospective MI and ADE data were combined from 3 sources: (1) voluntary

reports by nursing and medical staff; (2) voluntary reports by pharmacists, including “pharmacist interventions”, defined as“any action by a pharmacist that results in a change in medication management or therapy” 26; and (3) intensive chart review (including hand-written medication charts with adminis-tration records) by the study pharmacist by using standard clinical pharmacist review methods.26During data collection periods, voluntary reports were actively encouraged. Levels of physician ad-herence to safe prescribing guideline recommendations were determined by prospective chart review concurrent with MI and ADE data collection.

A new data collection tool (Supplemental Appendix 4) and process developed for this study was used to record MI/ADE data from all voluntary reports and chart review on study wards. The tool was based on literature review, existing

tools in use,27–29and input from a mul-tidisciplinary group of clinicians. Data collected included nature of the event, contributing factors, preventability, severity, likelihood of recurrence, and outcome. A unique aspect was a sepa-rate ADE section for recording relevant clinical information to enable system-atic evaluation of drug-related causal-ity.30 The tool was piloted to ensure feasibility in routine hospital practice. Educational sessions were conducted in study wards over 4 weeks before baseline data collection to familiarize clinical staff with the new tool and study procedures. Emphasis was placed on the importance of accurate data and multidisciplinary contribution to inform systems improvement.

Data Review

Data from all sources were reviewed by a multidisciplinary panel (senior nurses

FIGURE 2

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from study wards, study pharmacist, and pediatric clinical pharmacologist) to check accuracy and assign scores for severity, likelihood of recurrence, and preventability of medication errors. ADEs were additionally reviewed by another expert panel (a pediatric clin-ical pharmacologist and 2 pharma-cists) to systematically evaluate the probability of drug-related causality by using the Naranjo algorithm.30 Differ-ences were resolved by discussion and consensus scores assigned at the end of each panel meeting. A system of assigning severity was devised for consistent scoring by using categories specified in the statewide health ser-vice–mandated incident-monitoring sys-tem29 (see Table 3). Actual ADEs were assigned severity based on the actual patient outcome. Potential ADEs were assigned a “worst case scenario” po-tential severity specific to that drug and dose, even though the patient came to no actual harm (eg, liver failure if a high dose of paracetamol were prescribed for 1 week).

Statistical Analysis

Continuous data were analyzed by using the Kruskal-Wallis test, and categori-cal data were analyzed by using the Mantel-Haenszelx2test. Multiple com-parisons of continuous data were per-formed by using the Mann-Whitney test and categorical data by using the Mantel-Haenszelx2test. The Bonferroni correction was used for multiple pair-wise comparison.

RESULTS

A total of 1011 children and 6651 medication orders were reviewed over 3 time periods: at baseline (September 2003), 1 year (November 2004), and 4 years postimplementation (September 2007). Table 1 provides details of the evaluated patient cohorts. The age and gender of children in each cohort and their admitting diagnoses were similar across time periods (P..05).

MI (error) and ADE (harm) both de-creased in thefirst year, with improve-ments maintained at 4 years (Table 2). Total errors decreased from 4.51 per 100 orders at baseline to 2.78 per 100 orders at 4 years (P,.05). Medication errors relating specifically to pre-scribing, (the main target of our in-tervention) decreased by 65%, from 4.07 per 100 orders at baseline to 2.05 per 100 orders at 4 years (P,.05). Total ADEs decreased by .50%; from 19.22 per 100 patients at baseline to 8.59 per 100 patients at 4 years (P , .05). Greatest reductions were seen in potential ADE which decreased from 12.26 per 100 patients to 4.60 per 100 patients at 4 years (P,.05). Reductions in actual and preventable ADEs were also seen over the same period, but they did not reach statistical significance.

The severity of all ADEs are shown in Table 3. There were no major or serious actual ADEs observed at any time. Ap-proximately half of all actual ADEs were preventable, with the majority of minor severity. However, there were 5 major or serious potential ADEs at baseline (morphine prescribed instead of nal-oxone; double dose of paracetamol prescribed for a 2 year old; unclear paracetamol order, with potential 10-fold overdose for a 1 month old; and clotrimazole prescribed for eye instead of groin area). These types of ADEs were reduced to zero at 4-year follow-up.

The most common medicines involved in errors and ADEs were analgesics (30%–40%) and anti-infectives (25%– 33%).

Physician adherence to safe prescribing guideline recommendations improved incrementally over time for most para-meters (Fig 3). Introduction of the Pe-diatric National Inpatient Medication Chart in May 2007 was associated with additional improvements in parameters TABLE 2 Incidence of Error and Harm Events at Baseline, 1 y, and 4 y Postimplementation of

Safe-Prescribing Guidelines

Baseline 1 ya 4 yb

ERROR MIs per 100 ordersc

Total 4.51 3.02 2.78

Prescribing 4.07 2.50 2.05

Paracetamol 1.18 0.52 0.54

HARM ADEs per 100 patientsc

Total 19.22 10.43 8.59

Actual ADE 6.96 3.07 3.99

Preventable ADE 3.62 1.84 2.15

Potential ADE 12.26 7.36 4.60

See Fig 2 for definitions of terms.

aBaseline vs 1 y:P,.05 (x2test) for all except prescribing MI and preventable ADE. bBaseline vs 4 y:P,.05 (x2

test) for all except actual ADE (including preventable ADE).

cSee Table 1 for total numbers of orders and patients in each evaluation period.

TABLE 3 Number and Severity of Harm Events (ADEs) at Baseline, 1 y, and 4 y Postimplementation of Safe-Prescribing Guidelines

Baseline 1 y 4 y

Actual ADE (total) (25) (10) (13)

Nonpreventable 12 4 6

Minora 8 3 6

Moderateb 4 1 0

Majorc 0 0 0

Seriousd 0 0 0

Preventable 13 6 7

Minora 10 6 7

Moderateb 3 0 0

Majorc 0 0 0

Seriousd 0 0 0

Potential ADE (total) (44) (24) (15)

Minora 22 13 7

Moderateb 17 7 8

Majorc 4 4 0

Seriousd 1 0 0

See Fig 2 for definitions of ADE terms.29Data not shown for

minimum severity (no harm).

aMinor, increased level of care, eg, medical review and/or

referral, additional investigations or medical therapy;

bModerate, permanent reduction in bodily function; or

increased length of hospital stay; or surgical intervention required;

cMajor, major permanent loss of bodily function or dis

g-urement;

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that were better supported by the design of the new chart (eg, documentation of indication for use; mg/kg basis for dose calculation; prescriber pager), with other parameters remaining relatively stable or continuing on the preexisting trend toward improvement.

DISCUSSION

It is abundantly clear that“guidelines do not implement themselves,” with ef-fective and sustained change in practice requiring carefully planned (and resourced) implementation programs.31 Our safe pediatric prescribing guide-line implementation program was ef-fective in reducing medication errors and harm in hospitalized children and in improving aspects of prescribing. Substantial improvements in incidence of error and harm occurred 1 year af-ter guideline implementation and were sustained or further improved at 4 years. Ourfindings provide evidence for thefirst time that key recommendations

for preventing pediatric medication errors, when systematically imple-mented with the use of strategies with demonstrated effectiveness,20–22can produce significant and sustained im-provements in medication error and harm in hospitalized children. The na-ture, magnitude, and duration of im-provements we found are greater than those previously reported in the pedi-atric literature, including with CPOE systems, which have so far failed to demonstrate improvements in im-portant outcomes such as medication-related harm.14,15

We used a multifaceted guideline im-plementation model, engaging with multidisciplinary groups of clinicians.8, 9Our model integrates evidence-based guideline implementation strategies with the PDSA model of clinical practice improvement21and has previously been shown to be effective in improving spacer use in children with asthma20 and achieving sustained improvements in antibiotic prophylaxis in children

having surgery.22,32 The model incor-porates concepts from behavioral and social science theories and was tai-lored to the specific needs of our set-ting. Additional essential components important to achieving and sustaining improvements in clinical practice in-cluded: effective clinician leadership and facilitation31,33 (with specialized expertise in Pediatric Clinical Phar-macology and Therapeutics being an important feature here); improved com-munication between doctors, nurses, and pharmacists10; and timely and clin-ically meaningful data feedback that is valued by clinicians.34,35Iterative cy-cles of data feedback throughout the program, ongoing interactive educa-tion, and integration with routine sys-tems helped enhance and sustain the change. The 4-year sustained improve-ment we report is unique among pub-lished studies of pediatric medication error reduction strategies to date, the majority of which have been,1 year in duration.1

Data feedback that is perceived by clinicians as meaningful and valid has been identified as a key factor in achieving and sustaining effective change in hospital clinical practice.34,36 A major strength of our approach was that we evaluated the impact of our intervention on meaningful outcomes of medication errors and harm by us-ing standardized definitions and a comprehensive approach to measure-ment. In contrast to the majority of published studies, which rely on either voluntary reports of medication errors and harm and/or retrospective chart reviews, we used prospective data from multiple sources including vol-untary reports and chart review. This approach allowed calculation of error and harm rates rather than just counting numbers. It is acknowledged that voluntary or spontaneous report-ing systems do not provide an accurate measure of the incidence of errors and

FIGURE 3

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harm and are therefore not useful for evaluating the outcomes of interven-tions.37 However, they are often used for that purpose with gross under- or overestimates of the true extent of these problems. Our measured base-line incidence of 4.5 medication errors per 100 orders and potential ADE of 12 per 100 patients is similar to the rates reported by others with the use of a similar approach,6 supporting the validity of our methods and findings. Another key strength and unique aspect of our approach was the use of systematic causality evaluation30for all possible ADEs identified, further en-hancing the validity of our measure of medication-related harm. This addi-tional evaluation helps determine if there is a possible causal link between use of a medicine and an identified harm event, rather than mere associ-ation of an event with that medicine’s use or misuse, which is an important distinction. The majority of published research in medication safety is con-spicuous for the absence of this vital step, with important consequences for the validity of reported data on drug-related harm. This lack of causality evaluation also limits the“trigger tool” approach to ADE measurement38that has recently been used in several pe-diatric studies of medication safety39,40 and is being proposed for wider adoption.

Our innovative error and harm mea-surement method provided a valid and meaningful evaluation of the impact of the improvement model and contrib-uted to its effective implementation. Our approach provided a better under-standing of the extent and specific nature of errors and harm. In addition, detailed information about the type of ADEs and their level of preventability and severity enabled a more compre-hensive analysis of specific problem areas, assisting with tailoring our targeted interventions. The trends in

reduction of preventable and more severe ADEs, although not statistically significant, were clinically meaningful. Trend data were useful in providing feedback to clinicians to help maintain their engagement and sustain improve-ments over time. The greatest reduc-tions were in potential ADEs, indicating that our strategy had the desired im-pact on improving underlying system vulnerabilities.

A potential limitation of our study is its nonrandomized design. Although randomized controlled trials are the best method for evaluating efficacy of many interventions, other methods such as the interrupted time-series design are ac-knowledged as being better suited to evaluating the effectiveness of complex multilevel interventions in real-world settings.41 We used a modied in-terrupted time-series design with 1 baseline measurement and several postimplementation measurements. Whereas factors other than our im-provement model may have influenced outcomes, the observed sequence of changes in prescribing (specifically tar-geted by the program) and temporal association of incremental changes with specific interventions over time supports an intervention effect. Our improvement model has multiple com-ponents that were used as an inte-grated package, so it is not possible to distinguish the relative contribution from each. Although all of the compo-nents are currently accessible to most tertiary pediatric hospitals, appropri-ate additional resourcing and special-ized expertise (including in pediatric clinical pharmacology and therapeu-tics and in implementation science) was important to enable optimal im-plementation. We did not undertake a formal cost-effectiveness analysis. We estimate the cost of our overall pro-gram to be lower than the cost of harm events prevented, and many fold less than the millions of dollars in set-up

and maintenance costs of any CPOE systems currently available.

CONCLUSIONS

A clinician-led, multifaceted, evidence-based model for safe prescribing guideline implementation, engaging multidisciplinary clinicians, was effec-tive in reducing medication error and harm in hospitalized children and resulted in significant and sustained improvements over 4 years. This study provides evidence for thefirst time that key recommendations for improving pediatric prescribing, when systemat-ically implemented by using strategies with demonstrated effectiveness and supported by appropriate resources and expertise, can reduce medication errors and harm. Thisfinding is unique among published studies to date, the majority of which have not shown harm reduction or are of shorter duration. Our approach to measurement was useful both in providing a valid eval-uation of the overall impact of the intervention, and in contributing to enhancing its effectiveness through meaningful data feedback that was valued by clinicians.

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would enable more meaningful com-parisons of different medication safety improvement strategies and choice of strategy informed by better evidence of comparative effectiveness.

ACKNOWLEDGMENTS

The members of the Improving Medica-tion Safety in Children Project Team, Sydney Children’s Hospital, Randwick, were as follows: Dr Madlen Gazarian (Project Leader & Pediatric Clinical Pharmacologist); Ms Linda Graudins (Project Officer & Senior Pharmacist); Dr Elizabeth Argent (General Pediatri-cian); Ms Nikki Brown (Nurse Educa-tor); Dr Michael Brydon (Coordinator

of Clinical Services); Ms Helen Bullot (Nurse Unit Manager); Ms Margo Casaceli (Nurse Unit Manager); Ms Carolyn Dubury (Senior Pediatric Pharmacist); Dr Anna Gill (Chief Resident Medical Officer); Ms Sue Goh (Deputy Director of Pharmacy); Dr Hala Katf (Chief Resi-dent Medical Officer); Ms Jackie Ludher (Nursing Quality Coordinator); Ms Lynn MacRitchie (Nurse Unit Manager); Dr David Sandeman (Pediatric Anesthe-tist). We thank the many nurses, doc-tors and pharmacists at Sydney Children’s Hospital, Randwick, for their ongoing commitment to improving medication safety. We are especially grateful to the dedicated Nurse Unit

Managers of study wards (Helen Bullot, Margo Casaceli, and Lynn MacRitchie) whose unwavering support for the con-duct of the study and contribution to medication incident data review over 4 years was integral to its overall suc-cess. Members of the Improving Med-ication Safety in Children Project Team provided advice regarding prac-tical considerations and contributed to initial guideline development. Tara Stevermuer performed statistical anal-ysis. The Medical Illustrations Unit at the Prince of Wales Hospital, affiliated with the University of NSW, assisted with the design of the data collection tool and Guidelines posters.

REFERENCES

1. Miller MR, Robinson KA, Lubomski LH, Rinke ML, Pronovost PJ. Medication errors in paediatric care: a systematic review of epidemiology and an evaluation of evi-dence supporting reduction strategy rec-ommendations.Qual Saf Health Care. 2007; 16(2):116–126

2. Ghaleb MA, Barber N, Franklin BD, Yeung VWS, Khaki ZF, Wong ICK. Systematic review of medication errors in pediatric patients.

Ann Pharmacother. 2006;40(10):1766–1776

3. Kaushal R, Jaggi T, Walsh K, Fortescue EB, Bates DW. Pediatric medication errors: what do we know? What gaps remain?

Ambul Pediatr. 2004;4(1):73–81

4. World Health Organization. Promoting Safety of Medicines for Children. Geneva, Switzerland: WHO Press, World Health Or-ganization; 2007

5. Ghaleb MA, Barber N, Franklin BD, Wong ICK. The incidence and nature of pre-scribing and medication administration errors in paediatric inpatients. Arch Dis Child. 2010;95(2):113–118

6. Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events in pediatric inpatients.JAMA. 2001; 285(16):2114–2120

7. Wang JK, Herzog NS, Kaushal R, Park C, Mochizuki C, Weingarten SR. Prevention of pediatric medication errors by hospital pharmacists and the potential benefit of computerized physician order entry. Pedi-atrics. 2007;119(1). Available at: www.pe-diatrics.org/cgi/content/full/119/1/e77

8. Levine SR, Cohen MR, Blanchard NR, et al. Guidelines for preventing medication errors in pediatrics.J Pediatr Pharmacol Ther. 2001;6:426–442

9. Stucky ER; for American Academy of Pedi-atrics Committee on Drugs (2001-2002); and American Academy of Pediatrics Committee on Hospital Care (2002–2003). Prevention of medication errors in the pediatric inpatient setting.Pediatrics. 2003;112(2):431–436

10. Fortescue EB, Kaushal R, Landrigan CP, et al. Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients.Pediatrics. 2003;111 (4 pt 1):722–729

11. Shojania KG, Duncan BW, McDonald KM, Wachter RM. Safe but sound: patient safety meets evidence-based medicine. JAMA. 2002;288(4):508–513

12. Leape LL, Berwick DM, Bates DW. What practices will most improve safety? Evidence-based medicine meets patient safety.JAMA. 2002;288(4):501–507

13. Mollon B, Chong JJR Jr, Holbrook AM, Sung M, Thabane L, Foster G. Features pre-dicting the success of computerized deci-sion support for prescribing: a systematic review of randomized controlled trials.BMC Med Inform Decis Mak. 2009;9:11

14. Walsh KE, Landrigan CP, Adams WG, et al. Effect of computer order entry on preven-tion of serious medicapreven-tion errors in hos-pitalized children.Pediatrics. 2008;121(3). Available at: www.pediatrics.org/cgi/content/ full/121/3/e421

15. van Rosse F, Maat B, Rademaker CMA, van Vught AJ, Egberts ACG, Bollen CW. The effect of computerized physician order entry on medication prescription errors and clinical outcome in pediatric and intensive care: a systematic review. Pediatrics. 2009;123 (4):1184–1190

16. Koppel R, Metlay JP, Cohen A, et al. Role of computerized physician order entry sys-tems in facilitating medication errors.

JAMA. 2005;293(10):1197–1203

17. Han YY, Carcillo JA, Venkataraman ST, et al. Unexpected increased mor tality after implementation of a commercially sold computerized physician order entry system.

Pediatrics. 2005;116(6):1506–1512

18. Nebeker JR, Hoffman JM, Weir CR, Bennett CL, Hurdle JF. High rates of adverse drug events in a highly computerized hospi-tal.Arch Intern Med. 2005;165(10):1111– 1116

19. Potts AL, Barr FE, Gregory DF, Wright L, Patel NR. Computerized physician order entry and medication errors in a pediatric critical care unit. Pediatrics. 2004;113(1 pt 1): 59–63

20. Gazarian M, Henry RL, Wales SR, et al. Evaluating the effectiveness of evidence-based guidelines for the use of spacer devices in children with acute asthma.Med J Aust. 2001;174(8):394–397

21. Gibson PG. Implementing evidence-based guidelines.Med J Aust. 2001;174(8):377–378

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appropriateness of antibiotic prophylaxis in surgery: an innovative model for evidence-based guideline implementation and eval-uation.Clin Exp Pharmacol Physiol. 2004;31: A91

23. Graudins LV, Gazarian M. Promoting safe use of paracetamol in children. J Pharm Pract Res. 2006;36(4):297–300

24. Moulding NT, Silagy CA, Weller DP. A frame-work for effective management of change in clinical practice: dissemination and imple-mentation of clinical practice guidelines.

Qual Health Care. 1999;8(3):177–183

25. Davis D, Evans M, Jadad A, et al. The case for knowledge translation: shortening the journey from evidence to effect.BMJ. 2003; 327(7405):33–35

26. Society of Hospital Pharmacists of Australia (SHPA) Committee of Specialty Practice in Clinical Pharmacy. SHPA standards of prac-tice for clinical pharmacy. J Pharm Pract Res. 2005;35(2):122–146

27. Runciman WB, Sellen A, Webb RK, et al. The Australian Incident Monitoring Study. Errors, incidents and accidents in anaesthetic prac-tice.Anaesth Intensive Care. 1993;21(5):506– 519

28. Bagian JP, Lee C, Gosbee J, et al. De-veloping and deploying a patient safety program in a large health care delivery system: you can’tfix what you don’t know about. Jt Comm J Qual Improv. 2001;27 (10):522–532

29. Severity Assessment Code (SAC) description. New South Wales Department of Health Cir-cular 2003/88. Reportable Incident Briefs to the NSW Department of Health. North Sydney, Australia: New South Wales Depart-ment of Health; 2003

30. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–245

31. Grol R, Buchan H. Clinical guidelines: what can we do to increase their use?Med J Aust. 2006;185(6):301–302

32. Robertson S. Improving the Appropriate-ness of Antibiotic Prophylaxis in Surgery: an Innovative Model for Evidence-Based

Guideline Implementation and Evaluation

[Master of Science (by Research) Thesis]. Sydney, Australia: University of New South Wales; 2004. Available at: http://trove.nla.gov. au/work/30161235 Accessed February 26, 2012

33. Harvey G, Loftus-Hills A, Rycroft-Malone J, et al. Getting evidence into practice: the role and function of facilitation.J Adv Nurs. 2002;37(6):577–588

34. Bradley EH, Holmboe ES, Mattera JA, Roumanis SA, Radford MJ, Krumholz HM. Data feed-back efforts in quality improvement: les-sons learned from US hospitals.Qual Saf Health Care. 2004;13(1):26–31

35. Ostini R, Hegney D, Jackson C, et al. Systematic review of interventions to improve prescrib-ing.Ann Pharmacother. 2009;43(3):502–513

36. Lowinger JS, Stark HE, Kelly M, Hughes CF, Gazarian M, Kaye KI. Improving use of medi-cines with clinician-led use of validated clinical indicators.Med J Aust. 2010;192(4): 180–181

37. Shojania KG. The frustrating case of incident-reporting systems.Qual Saf Health Care. 2008;17(6):400–402

38. Griffin FA, Resar RK. IHI Global Trigger Tool for Measuring Adverse Events (second edition). IHI Innovation Series white pa-per. Cambridge, MA: Institute for Health Care Improvement; 2009. Available at: www. ihi.org/knowledge/Pages/IHIWhitePapers/ IHIGlobalTriggerToolWhitePaper.aspx. Accessed February 26, 2012

39. Takata GS, Mason W, Taketomo C, Logsdon T, Sharek PJ. Development, testing, andfindings of a pediatric-focused trigger tool to identify medication-related harm in US children’s hospitals. Pediatrics. 2008;121(4). Available at: www.pediatrics.org/cgi/content/full/121/ 4/e927

40. Sharek PJ, Horbar JD, Mason W, et al. Ad-verse events in the neonatal intensive care unit: development, testing, andfindings of an NICU-focused trigger tool to identify harm in North American NICUs.Pediatrics. 2006;118(4):1332–1340

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DOI: 10.1542/peds.2011-1902 originally published online April 2, 2012;

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DOI: 10.1542/peds.2011-1902 originally published online April 2, 2012;

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Figure

TABLE 1 Details of Evaluation Periods and Included Patients, at Baseline, 1 y, and 4 yPostimplementation of Safe-Prescribing Guidelines
FIGURE 2
TABLE 3 Number and Severity of HarmEvents (ADEs) at Baseline, 1 y, and4 y Postimplementation of Safe-Prescribing Guidelines

References

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