The frequency of potential DDIs was related to a higher number of drugs, being immunosuppressant and azole antifungal agents the most commonly involved drugs. The lack of agreement between different databases enhances the complexity to detect drug interactions in clinical practice.

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BackgroundAdverse drug reactions (ADRs) in children are a significant cause of hospitalisation. A systematic review published in 2013 estimates this incidence in the range from 0.16–4.3%.PurposeThe main objective was to describe the incidence of ADRs leading to admission in a paediatric hospital. Secondary objectives were to determine the drug classes causing ADRs, duration of hospitalisation and to compare the incidence obtained with the current literature.Material and methodsA retrospective study of all ADRs codes in the medical records of paediatric patients. ADRs were coded by a medical archivist for an 11-year period in a database.ResultsA total of 73,864 hospitalizations of children were evaluated. We detected 520 ADRs resulting in hospital admission. We calculated on average 47.4 ADRs coded per year for an annual average incidence of 0.7%. ADRs coded occurred amongst 0–5 year-olds and 12–17 year-olds in 53.7% and 18.2%, respectively. 49.3% were females. Mean hospitalisation time due to ADRs was 6.3 days.The organ systems most commonly involved were the haematopoietic system (63.4%), central nervous system (10.6%), digestive system (8.8%) and skin (6.1%). The classes of drugs most frequently involved were antineoplastic drugs (65.0%), drugs active on the central nervous system (8.6%) and anti-infective agents (5.8%).ConclusionThe incidence of ADRs as a cause of hospital admission in this study (0.7%) falls within the range of incidences in the current literature. The organ system most commonly involved is the haematopoietic system and the class of drug most frequently involved is antineoplastic drugs. Drug surveillance studies are necessary to characterise risk factors within this population and to test prevention strategies to effectively promote the safer use of drugs in children.ReferencesZed PJ, Haughn C, Black KJ, et al. Medication-related emergency department visits and hospital admissions in pediatric patients: a qualitative systematic review. J Pediatr 2013;163:477–83Gallagher RM, Mason JR, Bird KA, et al. Adverse drug reactions causing admission to a paediatric hospital. PLoS One 2012;7(12):e50127No conflict of interest.

BackgroundOsteoporosis (OP) is a systemic bone disease characterised by decreased bone mass and deterioration of bone microarchitecture with increased brittleness and fracture risk. It associates high morbidity and mortality for patients and has a high impact on health expenditure. Bone marrow stromal mesenchymal stem cells (BM-MSC) give rise to osteoprogenitor cells and osteoblasts and influence bone homeostasis. However after their intravenous (i/v) infusion their osteotropism is limited. Our group has demonstrated that the exofucosylation of the CD44 membrane antigen in MSC improves their homing to bone tissue and that the infusion of these cells is safe in a murine model.ObjectivesTo evaluate the safety of i/v infusion of fucosylated BM-MSC in patients with OP, and secondarily assess their ability to improve the course of the diseaseMethods10 women between 50 and 75 years old diagnosed with osteoporosis with a low impact fracture will be included and treated i/v with autologous fucosylated BM-MSC. The first 4 patients were treated with a dose of 2 × 106 cells/kg body weight and the other 6 with 5 × 106 cells/kg body weight. A 24 month follow-up will be conducted to evaluate the rate of severe and non-serious adverse events and secondary endpoints (decreased fracture rate, pain scores, functional status and quality of life, biochemical indexes of bone metabolism, quantitative computed tomography for morphometric and mechanical analysis of bone quality, densitometry, and histomorphometryResultsSeven patients have been recruited to date. Two left the study for lack of cell proliferation and appearance of a complex form in karyotype during the cell culture, respectively. The first 4 patients were successfully infused, and after a median follow-up of 3 months no related adverse effects have been observed, no new osteoporotic fractures have appeared, and the analogue pain scale score (EVA) shows a tendency to decrease of pain in 3 of the 4 patients.ConclusionsOur preliminary data indicate that clinical and GMP-grade production of BM-MSC is feasible. We have not observed any short-term adverse effects associated with treatment in infused patients.Disclosure of InterestNone declared

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