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Moulis F, Durrieu G, Lapeyre-Mestre M. Off-label and unlicensed drug use in children population. Therapie. 2018;73(2):135-149doi: 10.1016/j.therap.2018.02.002.
Moulis, F., Durrieu, G., & Lapeyre-Mestre, M. (2018). Off-label and unlicensed drug use in children population. Therapie, 73(2), 135-149. https://doi.org/10.1016/j.therap.2018.02.002
Moulis, Florence, et al. "Off-label and unlicensed drug use in children population." Therapie vol. 73,2 (2018): 135-149. doi: https://doi.org/10.1016/j.therap.2018.02.002
Moulis F, Durrieu G, Lapeyre-Mestre M. Off-label and unlicensed drug use in children population. Therapie. 2018 Apr;73(2):135-149. doi: 10.1016/j.therap.2018.02.002. Epub 2018 Feb 16. PMID: 29580614.
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Therapie. 2018 Apr;73(2):135-149. doi: 10.1016/j.therap.2018.02.002. Epub 2018 Feb 16.

Off-label and unlicensed drug use in children population.

Therapie

Florence Moulis, Geneviève Durrieu, Maryse Lapeyre-Mestre

Affiliations

  1. Department of medical and clinical pharmacology, Toulouse university hospital, faculty of medicine, 37, allées Jules-Guesde, 31000 Toulouse, France.
  2. Department of medical and clinical pharmacology, Toulouse university hospital, faculty of medicine, 37, allées Jules-Guesde, 31000 Toulouse, France. Electronic address: [email protected].

PMID: 29580614 DOI: 10.1016/j.therap.2018.02.002

Abstract

INTRODUCTION: Off-label (OL) and unlicensed (UL) drug use is widely developed in the pediatric population according to previous reviews published in the early 2010s. The present study is a narrative review of the literature of OL-UL drug use from 2013.

METHODS: We performed a literature search of research articles assessing OL-UL drug use in children (<18 years-old) published in Medline

RESULTS: Twenty-seven studies were included. OL drug use was defined by inappropriate age, indication, dosage or way of administration according to the summary of product characteristics in >80% of studies. UL drug used was defined by the use of drugs not licensed in the country or modifications of licensed drugs in >70% of studies. Among in- and out-patients, the frequency of patients exposed to at least one OL-UL drug ranged from 36.3 to 97.0% and from 18.6 to 40.2%, respectively. Drug use was categorized as OL mostly due to inappropriate age, dosage or indication. OL-UL drug use was the most prevalent in newborns (mainly preterms) and pre-school children (aged 2-5years). Various drugs were involved, depending on patients' age. Polypharmacy and long hospital stays were risk factors for OL-UL drug use. Whether OL-UL drug use leads to a higher incidence of adverse drug reactions is a controversial finding.

CONCLUSIONS: OL-UL drug use is frequent in children. A standardized definition of OL-UL drug use is needed to better assess its frequency, risk factors and impact.

Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Keywords: Children; Off-label drug use; Unlicensed drug use

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