Off-label and unlicensed drug use in children population.

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® from January 2013 until May 2017.

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.

• Authors: Florence Moulis, Geneviève Durrieu, Maryse Lapeyre-Mestre
• Journal: Therapie (Therapie) Vol. 73 Issue 2 Pg. 135-149 (Apr 2018) ISSN: 0040-5957 [Print] France
• PMID: 29580614 (Publication Type: Journal Article, Review)
• Copyright: Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Topics

• Humans
• Off-Label Use
• Pediatrics
• Practice Patterns, Physicians'