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.

BackgroundAlthough elderly patients with rheumatoid arthritis (RA) are probably the largest group of patients with RA, this age group has been excluded from clinical trials and therefore maximum evidence of effectiveness and safety data is not available. For this reason, it is interesting to conduct a study to evaluate the effectiveness and safety of treatment with anti-tumour necrosis factor (anti-TNF) in an elderly population.PurposeTo analyse and compare the effectiveness and safety of treatment with anti-TNF agents (adalimumab, etanercept and infliximab) in elderly patients (>65 years) with RA.Material and methodsA descriptive and retrospective study was conducted in a tertiary hospital with 800 beds. All patients aged >65 years diagnosed with RA treated with adalimumab, etanercept or infliximab were included from 2013 to 2015. The data analysis was performed using SPSS.ResultsThe sample for RA patients >65 years was 47 patients. 85% were women. 31.9% (n=15) were treated with infliximab, 29.8% (n=14) with etanercept and 38.3% (n=18) with adalimumab. Mean age was 71.7±5.2 years. At the end of the study period, 46.7% had discontinued treatment with infliximab, 41.2% with adalimumab and 28.6% with etanercept. The main reasons for treatment discontinuation were: remission in 13.3% for infliximab and 11.1% for adalimumab, therapeutic failure in 14.3% for etanercept and 16.6% for adalimumab, and adverse event in 11.1% for adalimumab. Median survival was 11.4 years (95% CI) for infliximab and 9.6 years (95% CI) for adalimumab. For etanercept, the median was not reached at the end of the study period. Survival at 5 years was 73% for infliximab, 75% for etanercept and 62% for adalimumab (log rank p=0.613; Breslow p=0.927). The main adverse effects observed were: infections and respiratory disorders for 3 drugs, followed by vascular disorders and asthenia for infliximab, renal and urinary disorders and eye disorders for adalimumab and gastrointestinal disorders for etanercept.ConclusionThe effectiveness of treatment with etanercept, adalimumab and infliximab in elderly patients showed no statistically significant differences in our study. The main adverse effects were infectious disorders, with the highest prevalence with infliximab and adalimumab.No conflict of interest

or dissemination syndrome. Safety was evaluated describing adverse events (AE). Results 35 COVID-19 patients from endemic areas were admitted and treated with ivermectin 6 mg/8 hours for 2 days. 52% of patients were women, with an average age of 42.84±11.38 years. The patients treated with ivermectin were from Latin America, and the most frequent countries were: 48% Bolivia, 24% Nicaragua, 12% Ecuador, 8% Colombia and 8% Peru. Immunosuppressive treatment was: 83% dexamethasone 6 mg/24 hours, 14% methylprednisolone bolus 250 mg, 12% tocilizumab 400 mg and 3% no immunosuppressive treatment. Three (9%) of the patients presented with positive S stercoralis serology. However, they did not develop S stercoralis hyperinfection or dissemination syndrome. Furthermore, no patient had eosinophilia, with an average eosinophiles blood count of 0.04±0.09×10 3 /mg. None of the patients had adverse events. Conclusion and relevance Prophylactic treatment with ivermectin was safe. Patients from endemic areas who should start immunosuppressive treatment as soon as possible could be treated prophylactically with ivermectin. Nevertheless, the number of patients and positive cases were small and more studies are needed to generate evidence.

BackgroundThe off-label drugs use in paediatrics is high and there are few studies undertaken on off-label drug use in Spain.PurposeTo analyse off-label drugs use in paediatrics services, to analyse which clinical units requested more often off-label drugs and which were the causes that led to the consideration of off-label treatment.Material and methodsDescriptive observational study from October 2009 to September 2014. We included all individual requests of off-label drugs received in the Pharmacy Department by the different paediatrics clinical units. Individualised assessment reports were developed with an analysis of efficacy, safety, convenience and cost, which were referred to hospital medical administration to make the decision to authorise or deny its use.ResultsA total of 141 requests were analysed, of which 95.1% (134) were finally authorised and 4.9% (7) were denied. The most petitioned drugs were Levosimendan with 14.9% (14 requests in cardiac surgery using extracorporeal circulation and 7 in diastolic dysfunction), Adalimumab with 8.5% (6 requests for juvenile idiopathic arthritis, 3 in ulcerative colitis and 3 for Crohn’s disease), Palivizumab with 6.4% (6 requests for prophylaxis of Human respiratory syncytial virus (RSV) in immunocompromised patients and 3 in treatment of RSV) and Pegfilgrastim with 4.9% (7 requests for neutropenia after chemotherapy in paediatric patients).According to cause which led to the consideration of off-label, in 58.2% (82) was due to an unauthorised indication. Furthermore, the reason for off-label in 41.8% (59) due to unauthorised indication for patient age.The most petitioned paediatrics clinical units were oncology with 46.1% (65), rheumatology with 12.1% (17), cardiology with 9.9% (14) and paediatric Intensive Care Unit with 8.5% (12).ConclusionThere is a variety of off-label drugs used in paediatric clinical units. Off-label drugs were requested mostly in the field of oncology and rheumatology. There were a high number of requests for drugs approved in adults but not in paediatric indications.References and/or acknowledgementsNo conflict of interest.