Case reports and observational studies continue to report adverse events from medical errors. However, despite considerable attention to patient safety in the popular media, this topic is not a regular component of medical education, and much research needs to be carried out to understand the causes, consequences, and prevention of healthcare-related adverse events during neonatal intensive care. To address the knowledge gaps and to formulate a research and educational agenda in neonatology, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invited a panel of experts to a workshop in August 2010. Patient safety issues discussed were: the reasons for errors, including systems design, working conditions, and worker fatigue; a need to develop a “culture” of patient safety; the role of electronic medical records, information technology, and simulators in reducing errors; error disclosure practices; medico-legal concerns; and educational needs. Specific neonatology-related topics discussed were: errors during resuscitation, mechanical ventilation, and performance of invasive procedures; medication errors including those associated with milk feedings; diagnostic errors; and misidentification of patients. This article provides an executive summary of the workshop.
assessments and regulatory advice and may indicate that current levels of MPB in formulations are acceptable for young children. Background and aims An essential step in drug dosing optimalisation is prospective validation of newly proposed dosing regimens. Based on a recently published population pharmacokinetic (PK) model, a neonatal amikacin dosing regimen was developed. The aim of the current study was to prospectively validate this model-derived dosing regimen. Methods Routine amikacin therapeutic drug monitoring (TDM) concentrations were prospectively collected. To test efficacy of the dosing regimen, early observed TDM results (i.e. prior to and 1 h after the second intravenous amikacin dose) reaching target concentrations (trough <3 mg/L, peak >24 mg/L) were defined. To test stability and accuracy of the model, all observed concentrations were compared with the predicted concentrations and a normalised prediction distribution error (NPDE) was performed. Monte Carlo simulations were used to evaluate amikacin exposure. Results In total, 1195 TDM results of 579 neonates [median gestational age 34 (range 24-41) weeks, postnatal age 2 (range 1-30) days] were included. Sixty percent of the early trough levels was below 3 mg/L, 90.4% of the peak levels reached 24 mg/L. Comparable parameter estimates were obtained between the final PK model and the prospective dataset. No trend was seen in the NPDE versus time and the NPDE versus predicted concentrations. Based on the Monte Carlo simulations, peak concentrations above 24 mg/L were reached in almost all patient subgroups. Conclusions After 14 years experience of amikacin dosing optimalisation in (pre)term neonates, a model-based dosing algorithm was prospectively validated confirming its efficacy, stability and accuracy over the entire neonatal population. O-107
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