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Purpose The objectives of our study were to determine drug use, type and incidence of all adverse event associated with drug or drug-related processes (Adverse Drug Events, ADE) among pediatric inpatients in relation to hospital unit and length of stay. Patients and Methods 600 pediatric (0–18 years) admissions at a Swedish university hospital during one year were included and stratified in blocks to 150 neonatal, surgical/orthopedic, medicine and emergency-medicine unit admissions, respectively. Adverse events were identified from medical records using a pediatric trigger tool. All triggers identifying an adverse event related to drugs and drug-related devices were included. Data on drug use were extracted from the hospital drug-data warehouse. Results In total, 17794 daily drug orders were administrated to 486 (81.0% exposed) admissions. Parental nutrition, potassium salts and morphine constituted half of all high-risk drugs prescribed. Two-thirds of intravenous irritating drug doses consisted of vancomycin, esomeprazole and meropenem. In 129 (21.5%) admissions, at least one ADE was identified, out of which 21 ADE were classified as more severe (National Coordinating Council Medication Error Reporting Prevention-Index, NCCMERP≥F). The ADE incidence was 47.4 (95% confidence interval: 39.4–57.3) per 1000 admission days and varied by unit category. In neonatal units, 56.9 (49.5–65.4) ADEs/1000 admission days were detected, in surgery/orthopedic 54.2 (40.3–72.8), in medicine 44.1 (33.1–58.7), and in emergency-medicine 14.3 (7.7–26.7) ADEs/1000 admission days were found. The most common types of ADEs were identified by triggers that were not directly aiming at drugs including insufficiently treated pain (incidence peaking already in the first days), skin, tissue or vascular harm (peaking at the end of the first week) and hospital-acquired infections (peaking in later admission days). Conclusion Adverse drug events are common in pediatric patients. The incidence of ADEs and type of ADE varies by hospital unit and length of hospital stay.

Background The nucleoside analog cladribine is used for the treatment of a variety of indolent B- and T-cell lymphoid malignancies. The primary aim of the study was to evaluate the population distribution of pharmacokinetic parameters in patients undergoing treatment with cladribine and to detect the influence of different covariates on the pharmacokinetic parameters. Methods This pharmacokinetic study presents the results of a retrospective population pharmacokinetic analysis based on pooled data from 161 patients, who were given cladribine in different administration routes in various dosing regimens. The plasma concentrations of cladribine were determined by reversed-phase high-performance liquid chromatography using a solid phase extraction with a limit of quantitation of 1 nM using 1 mL of plasma. Results A three compartment structural model best described the disposition of cladribine. Clearance was found to be 39.3 L/hour, with a large interindividual variability. The half-life for the terminal phase was 16 hours. Bioavailability was 100% and 35% for subcutaneous and oral administration, respectively, with low interindividual variability. None of the investigated covariates were found to be correlated with the pharmacokinetic parameters. Conclusion As interindividual variability in apparent clearance after oral administration was not significantly higher compared to that following infusion, cladribine could be administered orally instead of intravenously if compensated for its lower bioavailability. Individualized dosing on basis of body surface area or weight does not represent an improvement in this study as compared to administering a fixed dose to all patients.