BackgroundMany common drugs have not been licensed for use in children.MethodsThis study evaluated the incidence of unlicensed and off-label prescriptions at the Department of Pediatrics during a period of six months. A total of 8,559 prescriptions for 4,282 children were processed.ResultsOff-label and unlicensed prescriptions were found in 9.01% and 1.26% of all prescriptions, respectively. Unlicensed prescriptions were significantly more common in boys (1.5%) than in girls (1.0%) (p = 0.037). There was no significant difference between off-label prescriptions in boys (9.0%) and in girls (9.1%) (p = 0.89). The prescription of unlicensed drugs was significantly more frequent in school age children (p < 0.0001). The most commonly prescribed unlicensed drugs were angiotensin-converting enzyme inhibitors; among off-label drugs, antihistamines and bronchodilators.ConclusionsThis study shows that the incidence of unlicensed and off-label drug prescriptions in our patients is not as high as in other studies.

Adverse drug reactions (ADRs) are common problems in both paediatric and adult medicine. The aim of this study was to prospectively identify the ADRs causing hospital admission of children and identification of the risk factors and involved drugs. The study was performed at the University Hospital in Olomouc, Czech Republic. All patients aged 19 years or under admitted to hospital were included in the study, and all admissions for ADRs were prospectively screened for a period of 9 months. Suspected ADRs were subsequently evaluated in detail, and causality assessment was undertaken to determine whether each suspected reaction was possible, probable or definite. The assessment of ADR causality was performed using the Naranjo algorithm, the Liverpool ADR Causality Assessment Tool and the Edwards and Aronson causality assessment method. During the study period, 2903 admissions were identified; of these, there were 143 admissions of patients with an oncological disease. Sixty-four admissions (2.2%) were caused by an ADR. Anticancer chemotherapy accounted for 35% of the cases, followed by antibiotics (18%), immunosuppressants and vaccines (9% each). The use of different scoring systems does not lead to the differences in the numbers of ADR-diagnosed patient but may result in differences in the determination of the level of certainty. ADRs cause a substantial proportion of children's hospital admissions. The majority of the ADR-diagnosed patient affected the hematopoietic and gastrointestinal systems; the drugs most frequently involved were cytotoxic agents and antibiotics. The most important risk factors identified were female sex and oncological disease.

e105 Results: Factor VIII activity following administration of moroctocog alfa to haemophilia A patients was described with a 2-compartment disposition model including a baseline model. Covariates identified as predictors of the disposition were body size, age, inhibitors, race and analytical assay. Following the administration of plasma-derived factor IX to haemophilia B patients the activity was best characterised with a 3-compartment model with a baseline model, in which disposition parameters were related to body weight. It was found that accurate individual doses of factor IX could be obtained with few samples (2-3), provided that timing of sampling and data below the lower limit of quantification were handled appropriately. When choosing a sampling schedule, practicality has to be weighed against what is required for reasonable accuracy and precision in dose predictions. Conclusions: Our results were in agreement with previous publications but added quantitative information concerning the influence of low age and inhibitors on factor VIII disposition. The exploration of sampling schedules for model-based dose individualisation identified important factors to consider such at appropriate methodology and sufficient and practical sampling schedules.

Background Persistent left superior vena cava (PLSVC) is the most common variant of systemic venous drainage. In the absence of the right superior vena cava (RSVC), implantation of a right ventricular pacing lead may be challenging. Therefore specific implantation techniques and experiences in PLSVC are worth reporting. Case presentation We present a case report of a 90-year-old Caucasian female patient with PLSVC during single chamber pacemaker implantation due to the third-degree atrioventricular block. With common implantation techniques, we did not even reach the right ventricle. Therefore slittable CPS Direct ™ Universal sheath was employed to overcome the acute angle from PLSVC to tricuspid valve and ensure more fixation stability for longer 100-cm right ventricular lead placement. Conclusion This case demonstrates safe implantation of 100-cm long right ventricular bipolar active fixation pacing lead using common slittable CPS Direct ™ Universal sheath after failed attempts with „C“ and „J“ stylet shaped electrode. This sheath provides different angle towards tricuspid valve and more fixation stability in patient with PLSVC and absent connection to right atrium.