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Introduction. In pediatric intensive care units, a large number of drugs are used, many of which are prescribed for condition beyond those established in their summary of product characteristics (off-label and unlicensed drug prescriptions). The objective of this study was to describe drug use and estimate the prevalence of off-label and unlicensed drugs in a pediatric intensive care unit of a tertiary care Spanish hospital. Population and methods. Cross-sectional, observational study with a single cohort of children admitted to a pediatric intensive care unit. The study was conducted in 2017. Each drug prescription, its conditions of use and administration were reviewed. In addition, the summary of product characteristics of drugs used were analyzed in order to identify whether they were used according to their conditions of authorization, or whether they were used in an off-label or unlicensed manner. Results. The sample included 97 patients. At least one off-label or unlicensed drug was administered to 74.2% (n = 72) of patients; 23.8% (n = 243) corresponded to off-label prescriptions and 8.7% (n = 89), unlicensed prescriptions. A sub-analysis by age group showed that the age group that received a higher number of total prescriptions (n = 611) and a higher percentage of off-label and/or unlicensed drug prescriptions (38.4%) was under 2 years of age. Conclusions. Off-label and/or unlicensed drug prescription is a common practice in the pediatric intensive care unit. This study allowed us to document the complexity of therapeutics in children., (Sociedad Argentina de Pediatría.)

Introduction: The use of certain Complementary and Alternative Medicines (CAM) in children has been documented in Spain. The main aim of this study is to estimate the knowledge, recommendations, and use of CAM by Spanish paediatricians., Material and Methods: A national study was conducted from June to July 2020 using an online questionnaire. Two e-mails were sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP)., Results: Out of 1414 responses received, acupuncture was considered as a science by 31.8%. Homeopathy was recommended to parents by 28.1%. CAM was used by 21.3% of physicians, at least once, to improve their own health. Only 3.8% had ever replaced a conventional treatment with CAM. The following variables were associated with a greater disposition to prescribe homeopathy: female, age over 45 years old, paediatricians working in Primary Care, and paediatricians working in private healthcare., Conclusions: This AEP Committee on Medicines questionnaire provides new data that should be considered alarming and should ask for a serious thinking on the use of CAM in Spain. Some paediatricians are recommending parents to give treatments not supported by scientific evidence to their children. This practice could be potentially harmful, especially when conventional treatment is being replaced., (Copyright © 2021. Published by Elsevier España, S.L.U.)

Background: We aimed to determine the impact of tocilizumab use on severe COVID-19 (coronavirus disease 19) pneumonia mortality., Methods: We performed a multicentre retrospective cohort study in 18 tertiary hospitals in Spain from March to April 2020. Consecutive patients admitted with severe COVID-19 treated with tocilizumab were compared to patients not treated with tocilizumab, adjusting by inverse probability of the treatment weights (IPTW). Tocilizumab's effect in patients receiving steroids during the 48 h following inclusion was analysed., Results: During the study period, 506 patients with severe COVID-19 fulfilled the inclusion criteria. Among them, 268 were treated with tocilizumab and 238 patients were not. Median time to tocilizumab treatment from onset of symptoms was 11 days [interquartile range (IQR) 8-14]. Global mortality was 23.7%. Mortality was lower in patients treated with tocilizumab than in controls: 16.8% versus 31.5%, hazard ratio (HR) 0.514 [95% confidence interval (95% CI) 0.355-0.744], p < 0.001; weighted HR 0.741 (95% CI 0.619-0.887), p = 0.001. Tocilizumab treatment reduced mortality by 14.7% relative to no tocilizumab treatment [relative risk reduction (RRR) 46.7%]. We calculated a number necessary to treat of 7. Among patients treated with steroids, mortality was lower in those treated with tocilizumab than in those treated with steroids alone [10.9% versus 40.2%, HR 0.511 (95% CI 0.352-0.741), p = 0.036; weighted HR 0.6 (95% CI 0.449-0.804), p < 0.001] (interaction p = 0.094)., Conclusions: These results show that survival of patients with severe COVID-19 is higher in those treated with tocilizumab than in those not treated and that tocilizumab's effect adds to that of steroids administered to non-intubated patients with COVID-19 during the first 48 h of presenting with respiratory failure despite oxygen therapy. Randomised controlled studies are needed to confirm these results., Trial Registration: European Union electronic Register of Post-Authorization Studies (EU PAS Register) identifier, EUPAS34415.

Introduction: The use of certain Complementary and Alternative Medicines (CAM) in children has been documented in Spain. The main aim of this study is to estimate the knowledge, recommendations, and use of CAM by Spanish paediatricians., Material and Methods: A national study was conducted from June to July 2020 using an online questionnaire. Two e-mails were sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP)., Results: Out of 1,414 responses received, acupuncture was considered as a science by 31.8%. Homeopathy was recommended to parents by 28.1%. CAM was used by 21.3% of physicians, at least once, to improve their own health. Only 3.8% had ever replaced a conventional treatment with CAM. The following variables were associated with a greater disposition to prescribe homeopathy: female, age over 45 years old, paediatricians working in Primary Care, and paediatricians working in private healthcare., Conclusions: This AEP Committee on Medicines questionnaire provides new data that should be considered alarming and should ask for a serious thinking on the use of CAM in Spain. Some paediatricians are recommending parents to give treatments not supported by scientific evidence to their children. This practice could be potentially harmful, especially when conventional treatment is being replaced., (Copyright © 2020. Publicado por Elsevier España, S.L.U.)

Purpose: In the last decades, different criteria have been developed for detecting inappropriate prescription in older patients. In Spain, translations and adaptations of international lists are available but it would be necessary a national list which could cope with the peculiarities of our health system, existing pharmaceutical market, and prescription habits. We propose in this project the creation of a Spanish potentially inappropriate drugs list which could be applicable in our clinical scenario., Methods: We use a Delphi method involving 25 experts from different backgrounds (Clinical Pharmacology, Geriatrics, Rational Use of Drugs and Pharmacy, Primary Care and Pharmacoepidemiology, and Pharmacovigilance) that were asked to participate in two-round questionnaires. For analysis, current recommendations of Worth and Pigni were applied, and every statement was classified into one of three groups: strong, moderate, or low agreement. Statements with strong agreement were accepted to be part of the inadequate prescription list. Moderate agreement statements were selected to enter the second questionnaire, and statements with low agreement were further analyzed to determine if it was due to heterogeneity or due to dispersion in the answers., Results: The first questionnaire consisted of 160 proposed sentences, of which 106 reached a high agreement, 32 a moderate agreement, and 22 a low agreement. All sentences proposed in the second questionnaire reached a strong agreement. The total accepted sentences were 138., Conclusions: We offer a list of inadequate prescription in older patients adapted to the Spanish pharmacopeia and according to the prescription habits in our environment.

Background: Premature birth is considered one of the main problems in modern Obstetrics. It causes more than 50 % of neonatal mortality; it is responsible for a large proportion of infant morbidity and incurs very high economic costs. Cervical length, which can be accurately measured by ultrasound, has an inverse relationship with the risk of preterm birth. As a result, having an effective intervention for asymptomatic patients with short cervix could reduce the prematurity. Although recently published data demonstrates the effectiveness of vaginal progesterone and cervical pessary, these treatments have never been compared to one another., Methods/design: The PESAPRO study is a noncommercial, multicenter, open-label, randomized clinical trial (RCT) in pregnant women with a short cervix as identified by transvaginal ultrasonography at 19 to 22 weeks of gestation. Patients are randomized (1:1) to either daily vaginal progesterone or cervical pessary until the 37th week of gestation or delivery; whichever comes first. During the trial, women visit every 4 weeks for routine questions and tests. The primary outcome is the proportion of spontaneous preterm deliveries before 34 weeks of gestation. A sample size of 254 pregnant women will be included at 29 participating hospitals in order to demonstrate noninferiority of placing a pessary versus vaginal progesterone. The first patient was randomized in August 2012, and recruitment of study subjects will continue until the end of December 2015., Discussion: This trial assesses the comparative efficacy and safety between two accepted treatments, cervical pessary versus vaginal progesterone, and it will provide evidence in order to establish clinical recommendations., Trial Registration: EU Clinical Trials Register EudraCT2012-000241-13 (Date of registration: 16 January 2012); ClinicalTrials.gov Identifier NCT01643980 (Date of registration: 12 June 2012).

Introduction: Off-label drug use is a common practice in paediatrics. The aim of the present study was to estimate the knowledge of Spaniard paediatricians on off-label use., Material and Methods: Cross-sectional, multicentre, descriptive and national study from July 2012 to March 2013 using an on-line questionnaire on off-label use in children. An e-mail was sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP) or its Regional or Paediatric Specialties Societies., Results: Out of 673 responses were received, 75.1% of Spanish paediatricians knew the meaning of off-label use, 61% of them prescribed medicines outside the conditions authorised in their Summary of Product Characteristics (SPC) and 47% knew of the importance of noting the off-label use in the medical record. However, just under half of paediatricians informed parents, and only 22% wrote it down in the medical record., Conclusions: Most Spanish paediatricians do not meet current regulations regarding off-label use. This regulation demands: justifying the decisions when off-label use is needed, and to write down in the medical record that, at least an oral consent from the parents has been obtained. This study reveals a fact that Spanish paediatricians must change. Meanwhile, it is a priority to continue with the implementation of consensus and clinical guidelines, to obtain more data on the efficacy and safety of off-label drug use in children, and to incorporate them into the SPC., (Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.)

Introduction: There are currently several national guidelines on the appropriate empirical use of antibiotics in Spanish children. But, do the Spanish paediatricians use these guidelines when prescribing antimicrobials?, Material and Methods: A national study from was conducted from April to June 2012 using an on-line questionnaire on the empirical selection of antibiotics in children. An e-mail was sent to paediatrician members of the Spanish Association of Paediatrics (AEP) or its Regional or Paediatric Specialties Societies. Current guidelines and consensus documents were used to determine the appropriateness of the responses., Results: A total of 1214 responses were received. Eighty five per cent of the treatments selected by Spanish paediatricians were adjusted to guidelines. The least appropriate responses were obtained in those infectious diseases with no national consensus document at the time of the survey (73% in this case)., Conclusions: Spanish paediatricians mainly select empirical antibiotics in accordance with current guidelines. However, there are features that could be improved in our country. The preparing and implementation of national consensus documents on the management of paediatric infectious diseases should be continued. We propose to regularly perform these kinds of surveys, including real prescription studies, and to also extend it to other paediatric specialities, in order to promote appropriateness of use of all the paediatric drugs in our country., (Copyright © 2012 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.)