Benefit‐Risk Assessment of Off‐Label Drug Use in Children: The Bravo Framework

Author:

Zanden Tjitske M.123,Mooij Miriam G.4,Vet Nienke J.5,Neubert Antje6,Rascher Wolfgang6,Lagler Florian B.7,Male Christoph8,Grytli Helene9,Halvorsen Thomas10,Hoog Matthijs1,Wildt Saskia N.2311

Affiliation:

1. Department of Pediatrics Erasmus MC – Sophia Children’s Hospital Rotterdam The Netherlands

2. Departments of Pharmacology and Toxicology, and Intensive Care Radboud Institute Health Sciences Radboud University Medical Center Nijmegen The Netherlands

3. Dutch Knowledge Center Pharmacotherapy for Children Den Haag The Netherlands

4. Department of Pediatrics Leiden University Medical Centre – Willem‐Alexander Children’s Hospital Leiden The Netherlands

5. Department of Pediatrics St. Antonius Hospital Nieuwegein The Netherlands

6. Department of Pediatric and Adolescent Medicine University Hospital Erlangen Erlangen Germany

7. Department for Pediatrics and Institute for Inherited Metabolic Diseases Paracelsus Medical University Salzburg Austria

8. Department of Paediatrics and Adolescent Medicine Medical University of Vienna Austria

9. The Norwegian Medicines Manual for Health Personnel and Institute for Cancer Research Oslo University Hospital Oslo Norway

10. Department of Pediatric and Adolescent Medicine Medicines for Children Network, Norway Haukeland University Hospital Bergen Norway

11. Intensive Care and Pediatric Surgery Erasmus MC Sophia Children’s Hospital Rotterdam The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference86 articles.

1. Weda M.et al.Study on the off‐label use of medicinal products in the European Union.www.ec.europa.com; 2017 [updated March 14 2017].

2. Two decades of off-label prescribing in children: a literature review

3. Off‐label medication use in children, more common than we think: a systematic review of the literature;Allen H.C.;J. Okla. State Med. Assoc.,2018

4. Ten Common Questions (and Their Answers) About Off-label Drug Use

5. BAP Position Statement: Off-label prescribing of psychotropic medication to children and adolescents

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