Safety, Efficacy, and Timeliness of Intravenous Potassium Chloride Replacement Protocols in a Pediatric Cardiothoracic Intensive Care Unit.

OBJECTIVE: Hypokalemia in children following cardiac surgery occurs frequently, placing them at risk of life-threatening arrhythmias. However, renal insufficiency after cardiopulmonary bypass warrants careful administration of potassium (K+). Two different nurse-driven protocols (high dose and tiered dosing) were implemented to identify an optimal K+ replacement regimen, compared to an historical low-dose protocol. Our objective was to evaluate the safety, efficacy, and timeliness of these protocols. DESIGN: A retrospective cohort review of pediatric patients placed on intravenous K+ replacement protocols over 1 year was used to determine efficacy and safety of the protocols. A prospective single-blinded review of K+ repletion was used to determine timeliness. PATIENTS: Pediatric patients with congenital or acquired cardiac disease. SETTING: Twenty-four-bed cardiothoracic intensive care unit in a tertiary children's hospital. INTERVENTIONS: Efficacy was defined as fewer supplemental potassium chloride (KCl) doses, as well as a higher protocol to total doses ratio per patient. Safety was defined as a lower percentage of serum K+ levels ≥4.8 mEq/L after a dose of KCl. Between-group differences were assessed by nonparametric univariate analysis. RESULTS: There were 138 patients with a median age of 3.0 (interquartile range: 0.23-10.0) months. The incidence of K+ levels ≥4.8 mEq/L after a protocol dose was higher in the high-dose protocol versus the tiered-dosing protocol but not different between the low-dose and tiered-dosing protocols (high dose = 2.2% vs tiered dosing = 0.5%, P = .05). The ratio of protocol doses to total doses per patient was lower in the low-dose protocol compared to the tiered-dosing protocol (P < .05). Protocol doses were administered 45 minutes faster (P < .001). CONCLUSION: The tiered-dosed, nurse-driven K+ replacement protocol was associated with decreased supplemental K+ doses without increased risk of hyperkalemia, administering doses faster than individually ordered doses; the protocol was effective, safe, and timely in the treatment of hypokalemia in pediatric patients after cardiac surgery.

Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A Retrospective Chart Review.

OBJECTIVES: Half of prescription drugs commonly given to children lack product labeling on pediatric safety, efficacy, and dosing. Two drugs most widely used off-label in pediatrics are azithromycin and fentanyl. We sought to determine the risk of serious adverse events (SAEs) when oral azithromycin or intravenous/intramuscular fentanyl are used off-label compared to on-label in pediatric intensive care units (ICUs). STUDY DESIGN: Six pediatric hospitals participated in a retrospective chart review of patients administered oral azithromycin (n = 241) or intravenous/intramuscular fentanyl (n = 367) between January 5, 2013 and December 26, 2014. Outcomes were SAEs by drug and labeling status: off-label compared to on-label by Food and Drug Administration (FDA)-approved age and/or indication. Statistical analysis was performed using logistic regression to estimate odds ratios (ORs) and Cox regression to estimate hazard ratios (HRs). RESULTS: Twenty-one (9%) children receiving azithromycin experienced SAEs. Off-label use of azithromycin was not associated with a higher risk of SAE (OR 0.87, 95% CI 0.27-2.71, p = 0.81). Ninety-five (26%) children receiving fentanyl experienced SAEs. Fentanyl off-label use by both age and indication was not associated with a higher risk of overall SAEs compared to on-label use (OR 1.99, 95% CI 0.94-4.19, p = 0.07). However, the risk of the SAE respiratory depression was significantly greater when fentanyl was used off-label by both age and indication (OR 5.05, 95% CI 1.08-23.56, p = 0.044). Results based on HRs were similar. CONCLUSIONS: Azithromycin off-label use in pediatric ICUs does not appear to be associated with an increased risk of SAEs. Off-label use of fentanyl appears to be more frequently associated with respiratory depression when used off-label by both age and indication in pediatric ICUs. Prospective studies should be undertaken to assess the safety and efficacy of fentanyl in the pediatric population so that data can be added to the FDA labeling.

A Comprehensive List of Items to be Included on a Pediatric Drug Monograph.

OBJECTIVES: Children require special considerations for drug prescribing. Drug information summarized in a formulary containing drug monographs is essential for safe and effective prescribing. Currently, little is known about the information needs of those who prescribe and administer medicines to children. Our primary objective was to identify a list of important and relevant items to be included in a pediatric drug monograph. METHODS: Following the establishment of an expert steering committee and an environmental scan of adult and pediatric formulary monograph items, 46 participants from 25 countries were invited to complete a 2-round Delphi survey. Questions regarding source of prescribing information and importance of items were recorded. An international consensus meeting to vote on and finalize the items list with the steering committee followed. RESULTS: Pediatric formularies are most commonly the first resource consulted for information on medication used in children by 31 Delphi participants. After the Delphi rounds, 116 items were identified to be included in a comprehensive pediatric drug monograph, including general information, adverse drug reactions, dosages, precautions, drug-drug interactions, formulation, and drug properties. CONCLUSIONS: Health care providers identified 116 monograph items as important for prescribing medicines for children by an international consensus-based process. This information will assist in setting standards for the creation of new pediatric drug monographs for international application and for those involved in pediatric formulary development.

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 children's 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 >or=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 >or=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 children's hospital quality collaborative.

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 children's 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 children's 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 pruritus 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.