ArticleEuropean journal of pediatrics2020
Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Paediatrics and the European society for Developmental Perinatal and Pediatric Pharmacology.
Article in European journal of pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 71 papers, 3 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
71 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Off-Label Medicine Use in Pediatric Anesthesia-Recommendations of the World Federation of Societies of Anaesthesiologists (WFSA) Paediatric Committee.Paediatric anaesthesia · 2026Guideline
- Model-Informed Precision Dosing in Pediatric Patients: Current Software Tools and Bedside Guided Application.Paediatric drugs · 2026Pooled it
- Guideline for the management of pediatric off-label use of drugs in China (2021).BMC pediatrics · 2022Guideline
- Impact of a clinical decision support system on paediatric drug dose prescribing: a randomised within-subject simulation trial.BMJ paediatrics open · 2023Trial
- Enabling evidence generation for extremely preterm neonates: the use of neonatal real-world data.Pediatric research · 2026Review
- Off-label prescribing in pediatrics: between regulatory gaps and clinical evidence.Italian journal of pediatrics · 2026Article
- Pediatric Use of Off-Label Medicines and Nonevidence-Based Supplements for COVID-19: Findings From the 2015 Pelotas Birth Cohort Study (Brazil).Pharmacoepidemiology and drug safety · 2026Article
- "We've managed to find our own path of how we do it": exploring parental perceptions of using age-inappropriate formulations at home-a qualitative study.Frontiers in pediatrics · 2026Article
- Off-label prescribing in Italian pediatric practice: insights from a nationwide survey.European journal of pediatrics · 2025Article
- Taste-Masked Diclofenac Sodium Microparticles Prepared by Polyelectrolyte Complexation: Formulation Using Different Fatty Acids and Taste Evaluation by Human Panel.Pharmaceutics · 2025Article
- Exploring off-label vaccine use: a survey of the global national immunization technical advisory group network.Vaccine · 2025Article
- Utilization of Child-Appropriate Medicines: Use of Pediatric Use Marketing Authorisation (PUMA) Products in Croatia.Journal of clinical medicine · 2025Article
- Enhancing Drug Development for Paediatric Pulmonary Hypertension-An Integrative Perspective.Pulmonary circulation · 2025Review
- How Consistent are Anti-Infective Drug Dosing Recommendations Across Three European Paediatric Formularies?Paediatric drugs · 2025Article
- Exploring Manipulated Prescribed Medicines for Novel Leads in 3D Printed Personalized Dosage Forms.Pharmaceutics · 2025Article
- Prevalence and Patterns of Potentially Inappropriate Prescribing by Brazilian Dentists for Pediatric Patients: A Cross-Sectional Study.BioMed research international · 2025Article
- Pediatric Orally Disintegrating Tablets (ODTs) with Enhanced Palatability Based on Propranolol HCl Coground with Hydroxypropyl-β-Cyclodextrin.Pharmaceutics · 2024Article
- Assessing solubility of meloxicam in age-specific gastric and intestinal media relevant to adults and pediatric populations: implications for optimizing dosing in patients for postoperative pain.BMC pharmacology & toxicology · 2024Article
- The implementation of the guideline for the management of pediatric off-label use of drugs in China: a cross-sectional study.Translational pediatrics · 2024Article
- Ototoxic and nephrotoxic drugs in neonatal intensive care units: results of a Spanish and Italian survey.European journal of pediatrics · 2024Article
11 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Health-care professionals who prescribe medicines have the professional duty to choose medicines that are in the best interest of their individual patient, irrespective if that patient is an adult or a child. However, the availability of medicines with an appropriate label for pediatric use is lagging behind those for adults, and even available pediatric drugs are sometimes not suitable to administer to children. Consequently, health-care professionals often have no other option than to prescribe off-label medicines to children. An important reason for use of off-label medicines is to improve access to (innovative) treatments or to address medical needs and preferences of patients, especially when no other options are available. However, off-label use of medicines is in general not supported by the same level of evidence as medicines licensed for pediatric use. This may result in increased uncertainty on efficacy as well as the risk for toxicity and other side effects. In addition, liability may also be of concern, counterbalanced by professional guidelines.Conclusion: The purpose of this joint EAP/ESDPPP policy statement is to offer guidance for HCPs on when and how to prescribe off-label medicines to children and to provide recommendations for future European policy.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.