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This is a registry-based study with the aim of describing and comparing the frequency of manipulations of solid oral and rectal medicines in 2009 and 2019 at inpatient units and an emergency department in a paediatric hospital within a Swedish university hospital. All patients aged 1 month-18 years with oral or rectal administrations were included. In total, 140,791 oral and rectal administrations were included in 2009, and 167,945 oral and rectal administrations were included in 2019. The frequency of patients receiving at least one manipulated oral medicine decreased between the study years, both in inpatient units and in the emergency department (from 19% to 17%, p = 0.0029 and from 11% to 5%, p < 0.0001, respectively). The frequency of patients receiving a manipulated rectal medicine also decreased between the study years, both in inpatient units and in the emergency department (from 22% to 10%, p < 0.0001 and from 35% to 7% 2019, p < 0.0001, respectively). The results show a decrease in the manipulation of both oral and rectal medicines to paediatric patients in 2019 compared to 2009. Even though this implies a safer practice, there is still a pronounced lack of child-friendly dosage forms and suitable strengths enabling the safe administration of medicines to sick children.

AIM: To explore the incidence and characteristics of inpatient neonatal adverse events in a Swedish setting. METHODS: A retrospective record review, using a trigger tool, performed by registered nurses and a neonatologist, at a University Hospital. The identified adverse events were categorised by, for example, preventability, severity and time of occurrence. RESULTS: A random selection of 150 admissions representing 3531 patient days were reviewed (mean [SD] birthweight 2620 [1120]g). Three hundred sixty adverse events were identified in 78(52.0%) infants and 305(84.7%) of these were assessed as being preventable. The overall adverse event rate was 240 per 100 admissions and 102.0 per 1000 patient days. Preterm infants had a higher rate than term infants (353 versus 79 per 100 admissions, p=0.001), however with regard to the length of stay, the rates were similar. Most adverse events were temporary and less severe (n=338/360, 93.9%) and the most common type involved harm to skin, tissue or blood vessels (n=163/360, 45.3%). Forty percent (n=145) of adverse events occurred within the first week of admission. CONCLUSION: Adverse events were common in neonatal care and many occurred during the first days of treatment. Characterisation of adverse events may provide focus areas for improvements in patient safety.

Aim: The aims were to characterise paediatric medication errors and to identify the prevalence of known high-alert substances in these errors. Methods: All paediatric drug-related incident reports and complaints nationally reported to the Health and Social Care Inspectorate in Sweden 2011-2017 regarding inpatients were characterised by context and modal details. In addition, drug use at a university hospital was matched to local incident reports. Drug substances were classified using three high-alert lists. Results: On a national level, there were 160 reports (2.5 per 10 000 patients) in which the three high-alert lists were found in different degrees (17/35/47%). Morphine (n = 12), vancomycin (n = 11) and potassium (n = 7) were most frequently involved. Eighty per cent of the reports concerned patients aged 0-6 years. Intravenous was the most common route of administration (66%). On a university hospital level, the prevalence of all types of drug incidents reports was 1.7% among all inpatients. The prevalence of local incident reports involving high-alert substances was almost double that of non-alert substances. Conclusion: Existing high-alert drug lists are relevant for paediatric inpatients. A higher awareness and usage of such lists among hospital staff prescribing, dispensing and administering drugs to children may have the potential to reduce medication errors.

Background: In pediatrics, treatment with drugs is an important and fully integrated part of everyday medical practice. However, authorized drugs specified to be used in children are often lacking which leads to off-label use, i.e. outside of approved product monographs. Another challenge is medication errors (ME) which is an important cause of adverse drug events (ADE) in hospitalized children. The consequences and effects of these conditions are largely unknown. Studies within the field of pediatric, and especially neonatal, drug safety are lacking. Unsafe drug use may be an important and unrecognized contributor to suboptimal health in this vulnerable group with limited capacity for drug metabolism and excretion. Aim: The general aim of the thesis was to explore the magnitude of drug safety issues within Swedish pediatric inpatients. More specifically we aimed to investigate; I. National extent of off-label drug-use, II. Contents in national ME incident reports, III. Type of ADEs in a pediatric inpatient setting and IV. The views of pediatricians on a clinical decision support system (CDSS) to aid in prescribing drugs. Methods: In the four papers we used different study approaches. In paper I we performed a descriptive cross-sectional study based on collection of drug charts during two time-points. In paper II we used an analytic cross-sectional register-based study on Lex Maria incident reports and complaints from the Health and Social Care Inspectorate. In paper III we carried out a cohort study using a chart review with a pediatric trigger tool covering 600 admissions stratified in four different units, and in paper IV we used qualitative semi-structured interviews with pediatricians. Results: Paper I showed that half of all drug orders received by pediatric inpatients was outside approved product monographs, extemporaneously prepared or unlicensed. In paper II the ME reports indicated frequent occurrence of substances from three previously known high-alert li

Per Nydert, 1, 2 Maria Unbeck, 3, 4 Karin Pukk Härenstam, 1, 5 Mikael Norman, 1, 2 Synnöve Lindemalm 1, 2 1Astrid Lindgren’s Children’s Hospital, Karolinska University Hospital, Stockholm, Sweden; 2Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden; 3Trauma and Reparative Medicine Theme, Karolinska University Hospital, Stockholm, Sweden; 4Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden; 5Medical Management Centre, Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, SwedenCorrespondence: Per NydertAstrid Lindgren Children´s Hospital at Karolinska University Hospital, Stockholm SE-171 76, SwedenTel +46 8 51770000Email per.nydert@sll.sePurpose: 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

BACKGROUND: Tacrolimus is an immunosuppressant with a narrow therapeutic window, with considerable pharmacokinetic variability. Getting sufficient concentrations in pediatric liver transplantation is imperative, but it has proven difficult in the immediate posttransplantation period in particular. A predictive pharmacokinetic model could be the basis for development of a novel initial dose schedule, and therapeutic drug monitoring with Bayesian methodology. METHODS: The predictive capacity of 2 previously developed population pharmacokinetic models of tacrolimus in pediatric liver transplant recipients was tested in 20 new patients using Bayesian forecasting. Predictive performance was poor in the immediate posttransplant period with tacrolimus pharmacokinetics changing rapidly. A new population pharmacokinetic model, focusing on the immediate posttransplant period, was subsequently developed in 73 patients. RESULTS: An increase in the apparent clearance of tacrolimus in the first few weeks after transplant was evident. Typical apparent clearance of tacrolimus was 0.148 L·h·kg immediately after transplantation, increasing to a maximum of 1.37 L·h·kg. Typical apparent distribution volume was 27.2 L/kg. Internal and external validation studies confirmed the predictive capabilities of the developed model. Simulation studies reveal that in 60% of subjects the current initial standard dose without subsequent dosage adjustments overshoot the desired trough concentration range of 10-20 ng/mL. An alternative dosing schedule was developed based on allometric scaling with an initial loading dose followed by a maintenance dose increasing with time. CONCLUSIONS: A population pharmacokinetic model for tacrolimus was developed, to better describe the early posttransplantation phase. This model has the potential to aid therapeutic drug monitoring and was also used to suggest a revised dosing scheme in the intended population.