Evidenzbasierte Off-label-Anwendung von Arzneimitteln bei Kindern und Jugendlichen

Male C, Neubert A, Grytli H, Gradwohl C, Strommer B, Lagler FB, Rascher W, Halvorsen T, De Wildt SN, Van Der Zanden TM (2022)

Publication Type: Journal article, Review article

Publication year: 2022

Journal

Monatsschrift Kinderheilkunde Springer Verlag (Germany)

DOI: 10.1007/s00112-022-01418-7

Abstract

In spite of an improved regulatory framework to facilitate development of drugs for children, there are still large deficits in available drugs for many pediatric therapeutic areas and, in particular for the youngest age groups. Therefore, many drugs must be used off-label for children and consequently without pediatric product information. Off-label use is associated with increased risks of inadequate dosing, lack of efficacy or adverse effects. Off-label use implies an increased responsibility for prescribers to rely on the best-available evidence for using age-appropriate doses and assessing the benefits and risks. This responsibility cannot be left to the individual prescriber as the few existing data from academic studies are of heterogeneous quality and not readily available. The international consortium of pediatric formularies is a collaboration of currently four European countries (The Netherlands, Germany, Austria, Norway), which builds on the Dutch Kinderformularium. The consortium provides drug information for children and adolescents based on best-available evidence; the information is compiled by systematic search, critical appraisal, expert review, international harmonization, and periodic updating, and is transparently referenced. The information is freely available for users on web-based platforms in the respective national language. The international consortium of pediatric formularies provides the basis for off-label drug use in children and adolescents, by providing the best-available evidence for choosing age-appropriate doses and weighing the benefits versus the risks.

Authors with CRIS profile

Antje Neubert Department of Paediatrics and Adolescent Medicine Wolfgang Rascher Department of Paediatrics and Adolescent Medicine

Involved external institutions

Oslo University Hospital / Oslo Universitetssykehus Rikshospitalet NO Norway (NO) Paracelsus Medizinische Privatuniversität AT Austria (AT) Medizinische Universität Wien AT Austria (AT) Haukeland University Hospital / Haukeland universitetssykehus NO Norway (NO)

How to cite

APA:

Male, C., Neubert, A., Grytli, H., Gradwohl, C., Strommer, B., Lagler, F.B.,... Van Der Zanden, T.M. (2022). Evidenzbasierte Off-label-Anwendung von Arzneimitteln bei Kindern und Jugendlichen. Monatsschrift Kinderheilkunde. https://doi.org/10.1007/s00112-022-01418-7

MLA:

Male, Christoph, et al. "Evidenzbasierte Off-label-Anwendung von Arzneimitteln bei Kindern und Jugendlichen." Monatsschrift Kinderheilkunde (2022).

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