Glenn Takata

Development, Testing, and Findings of a Pediatric- Focused Trigger Tool to Identify Medication-Related Harm in US Children's Hospitals

OBJECTIVES. The purposes of this study were to develop a pediatric-focused tool for adverse drug event detection and describe the incidence and characteristics of adverse drug events in childrens hospitals identified by this tool. METHODS. A pediatric-specific trigger tool for adverse drug event detection was developed and tested. Eighty patients from each site were randomly selected for retrospective chart review. All adverse drug events identified using the trigger tool were evaluated for severity, preventability, ability to mitigate, ability to identify the event earlier, and presence of associated occurrence report. Each trigger and the entire tool were evaluated for positive predictive value. RESULTS. Review of 960 randomly selected charts from 12 childrens hospitals revealed 2388 triggers (2.49 per patient) and 107 unique adverse drug events. Mean adverse drug event rates were 11.1 per 100 patients, 15.7 per 1000 patient-days, and 1.23 per 1000 medication doses. The positive predictive value of the trigger tool was 3.7%. Twenty-two percent of all adverse drug events were deemed preventable, 17.8% could have been identified earlier, and 16.8% could have been mitigated more effectively. Ninety-seven percent of the identified adverse drug events resulted in mild, temporary harm. Only 3.7% of adverse drug events were identified in existing hospital-based occurrence reports. The most common adverse drug events identified were pruritis and nausea, the most common medication classes causing adverse drug events were opioid analgesics and antibiotics, and the most common stages of the medication management process associated with preventable adverse drug events were monitoring and prescribing/ordering. CONCLUSIONS. Adverse drug event rates in hospitalized children are substantially higher than previously described. Most adverse drug events resulted in temporary harm, and 22% were classified as preventable. Only 3.7% were identified by using traditional voluntary reporting methods. Our pediatric-focused trigger tool is effective at identifying adverse drug events in inpatient pediatric populations.

Diagnosis, Microbial Epidemiology, and Antibiotic Treatment of Acute Otitis Media in Children: A Systematic Review

CONTEXT Acute otitis media (AOM) is the most common condition for which antibiotics are prescribed for US children; however, wide variation exists in diagnosis and treatment. OBJECTIVES To perform a systematic review on AOM diagnosis, treatment, and the association of heptavalent pneumococcal conjugate vaccine (PCV7) use with AOM microbiology. DATA SOURCES PubMed, Cochrane Databases, and Web of Science, searched to identify articles published from January 1999 through July 2010. STUDY SELECTION Diagnostic studies with a criterion standard, observational studies and randomized controlled trials comparing AOM microbiology with and without PCV7, and randomized controlled trials assessing antibiotic treatment. DATA EXTRACTION Independent article review and study quality assessment by 2 investigators with consensus resolution of discrepancies. RESULTS Of 8945 citations screened, 135 were included. Meta-analysis was performed for comparisons with 3 or more trials. Few studies examined diagnosis; otoscopic findings of tympanic membrane bulging (positive likelihood ratio, 51 [95% confidence interval {CI}, 36-73]) and redness (positive likelihood ratio, 8.4 [95% CI, 7-11]) were associated with accurate diagnosis. In the few available studies, prevalence of Streptococcus pneumoniae decreased (eg, 33%-48% vs 23%-31% of AOM isolates), while that of Haemophilus influenzae increased (41%-43% vs 56%-57%) pre- vs post-PCV7. Short-term clinical success was higher for immediate use of ampicillin or amoxicillin vs placebo (73% vs 60%; pooled rate difference, 12% [95% CI, 5%-18%]; number needed to treat, 9 [95% CI, 6-20]), while increasing the rate of rash or diarrhea by 3% to 5%. Two of 4 studies showed greater clinical success for immediate vs delayed antibiotics (95% vs 80%; rate difference, 15% [95% CI, 6%-24%] and 86% vs 70%; rate difference, 16% [95% CI, 6%-26%]). Data are absent on long-term effects on antimicrobial resistance. Meta-analyses in general showed no significant differences in antibiotic comparative effectiveness. CONCLUSIONS Otoscopic findings are critical to accurate AOM diagnosis. AOM microbiology has changed with use of PCV7. Antibiotics are modestly more effective than no treatment but cause adverse effects in 4% to 10% of children. Most antibiotics have comparable clinical success.

Policy statement - Principles of pediatric patient safety: Reducing harm due to medical care

Pediatricians are rendering care in an environment that is increasingly complex, which results in multiple opportunities to cause unintended harm. National awareness of patient safety risks has grown in the 10 years since the Institute of Medicine published its report To Err Is Human, and patients and society as a whole continue to challenge health care providers to examine their practices and implement safety solutions. The depth and breadth of harm incurred by the practice of medicine is still being defined as reports continue to uncover a variety of avoidable errors, from those that involve specific high-risk medications to those that are more generalizable, such as patient misidentification. Pediatricians in all venues must have a working knowledge of patient-safety language, advocate for best practices that attend to risks that are unique to children, identify and support a culture of safety, and lead efforts to eliminate avoidable harm in any setting in which medical care is rendered to children.

Characteristics of medication errors and adverse drug events in hospitals participating in the California Pediatric Patient Safety Initiative

PURPOSE The characteristics of medication errors and adverse drug events (ADEs) in hospitals participating in the California Pediatric Patient Safety Initiative (CaPPSI) were studied to identify opportunities for improvement. METHODS Data were collected to identify pharmacy intervention medication errors (PIMEs) with significant harm potential and ADEs identified by a validated pediatric trigger method (TADEs) and by voluntary incident reports (VADEs) from November 2003 through April 2004. Electronic trigger identification was used. The primary outcomes measured were PIMEs, TADEs, and VADEs and the characteristics of these medication errors and ADEs. A secondary outcome measure was the positive predictive value of the trigger tool. RESULTS The rates of PIMEs, TADEs, and VADEs were 2.67, 22.3, and 1.7 per 1000 patient days, respectively. PIMEs and ADEs occurred mostly among patients age one year or older during days 0 and 1 of admission and involved the following medication categories: antiinfectives and antibiotics, analgesics and antipyretics, and electrolytic-, caloric-, and water balance-replacement preparations. Most PIMEs involved an incorrect dosage or the wrong drug. Primary diagnoses differed between those with PIMEs and VADEs and those with TADEs. All medication processes were in need of improvement except dispensing. The trigger tool identified more ADEs than did voluntary incident reports by a factor of 11 and had a positive predictive value of 16.8%. CONCLUSION Baseline rates of PIMEs, TADEs, and VADEs for pediatric hospitals in California were determined through collaborative efforts of CaPPSI facilities. Identification of ADEs was more effective when a trigger tool was used than when incidents were voluntarily reported.

An Intervention to Decrease Narcotic-Related Adverse Drug Events in Children's Hospitals

OBJECTIVES. Narcotic-related adverse drug events are the most common adverse drug events in hospitalized children. Despite multiple published studies describing interventions that decrease adverse drug events from narcotics, large-scale collaborative quality improvement efforts to address narcotic-related adverse drug events in pediatrics have not been described. The purpose of this study was to evaluate collaborative-wide narcotic-related adverse drug event rates after a collection of expert panel–defined best practices was implemented. METHODS. All 42 childrens hospitals in the Child Health Corporation of America were invited to participate in the Institute for Healthcare Improvement–style quality improvement collaborative aimed at reducing narcotic-related adverse drug events. A collection of interventions known or suspected to reduce narcotic-related adverse drug events was recommended by an expert panel, with each site implementing ≥1 of these best practices on the basis of local need. Narcotic-related adverse drug event rates were compared between the baseline (December 1, 2004, to March 31, 2005) and postimplementation periods (January 1, 2006, to March 31, 2006) after an a priori–defined intervention ramp-up time (April 1, 2005, and December 31, 2005). Secondary outcome measures included constipation rates and narcotic-related automated drug-dispensing-device override percentages. RESULTS. Median narcotic-related adverse drug event rates decreased 67% between the baseline and postimplementation time frames across the 14-site collaborative. Constipation rates decreased 68.9%, and automated drug-dispensing-device overrides decreased from 10.18% to 5.91% of all narcotic doses administered. CONCLUSIONS. Implementation of ≥1 expert panel–recommended interventions at each participating site resulted in a significant decrease in narcotic-related adverse drug events, constipation, and automated drug-dispensing-device overrides in a 12-month, 14-site childrens hospital quality collaborative.

Sustaining and Spreading the Reduction of Adverse Drug Events in a Multicenter Collaborative

OBJECTIVES: Adverse drug events (ADEs) occur more frequently in pediatric patients than adults. ADEs frequently cause serious harm to children and increase the cost of care. The purpose of this study was to decrease ADEs by targeting the entire medication-delivery system for all high-risk medications. METHODS: Thirteen freestanding childrens hospitals participated in this ADE collaborative. An advisory panel developed a change package of interventions that consisted of standardization of medication-ordering (eg, consensus-based protocols and order sets and high-alert medication protocols), reliable medication-dispensing processes (eg, automated dispensing cabinets and redesign of floor stock procedures), reliable medication-administration processes (eg, safe pump use and reducing interruptions), improvement of patient safety culture (eg, safety-culture changes and reduction of staff intimidation), and clinical decision support (eg, increase ADE detection and redesign care systems). ADE rates were compared from the 3-month baseline period to quarters of the 12-month intervention phase. ADE rates were categorized further as opioid related and other medication related. RESULTS: From baseline to the final quarter, the collaborative resulted in a 42% decrease in total ADEs, a 51% decrease in opioid-related ADEs, and a 41% decrease in other medication ADEs. CONCLUSION: A pediatric collaborative that targeted the medication-delivery system decreased the rate of ADEs at participating institutions.

Toward transparent clinical policies.

Clinical policies of professional societies such as the American Academy of Pediatrics are valued highly, not only by clinicians who provide direct health care to children but also by many others who rely on the professional expertise of these organizations, including parents, employers, insurers, and legislators. The utility of a policy depends, in large part, on the degree to which its purpose and basis are clear to policy users, an attribute known as the policys transparency. This statement describes the critical importance and special value of transparency in clinical policies, guidelines, and recommendations; helps identify obstacles to achieving transparency; and suggests several approaches to overcome these obstacles.