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Pediatrics. 2015 Jan;135(1):49-58. doi: 10.1542/peds.2014-0764. Epub 2014 Dec 15.

Off-label prescribing in pediatric outpatients.

Author information

1
Laboratoire de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Equipe de Pharmacoépidémiologie, INSERM U1027, Centre Hospitalier Universitaire, Faculté de Médecine, Université de Toulouse, France; and.
2
Département Universitaire de Médecine Générale des Facultés de Médecine de Toulouse, France.
3
Laboratoire de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Equipe de Pharmacoépidémiologie, INSERM U1027, Centre Hospitalier Universitaire, Faculté de Médecine, Université de Toulouse, France; and maryse.lapeyre-mestre@univ-tlse3.fr.

Abstract

OBJECTIVE:

To study the characteristics of off-label prescribing and adverse drug reaction (ADR) occurrence in a sample of pediatric outpatients treated by general practitioners.

METHODS:

A survey on pediatric drug prescribing was implemented in 46 general practices in southwestern France. All consecutive patients aged 0 to 16 years were included. Patient characteristics, reasons for consultation, and drug prescribed (including indications) were collected. ADRs occurring ≤10 days after the date of consultation were recorded by the general practitioners (spontaneous notification). Off-label prescription was defined as prescribing outside the specifications of the Summary of Product Characteristics.

RESULTS:

Among the 2313 children seen between March 8, 2011 and July 31, 2011, 1960 were exposed to ≥1 prescribed drug. Mean age was 5.6 years, with a gender ratio of 1.1. Among children with prescriptions, 37.6% (n = 736) were exposed to ≥1 off-label prescription and 6.7% (n = 132) to ≥1 unlicensed drug. Off-label prescribing involved an unapproved indication in 56.4% of cases (n = 416), a lower dosage (26.5%, n = 195) or higher dosage (19.5%, n = 144) than specified, age not labeled (7.2%, n = 53), incorrect route of administration (3.5%, n = 26), and contraindication (0.3%, n = 2). A total of 23 ADRs were reported (1.5% of patients with off-label prescriptions). ADR occurrence was not significantly related to off-label drug prescribing.

CONCLUSIONS:

Despite the numerous initiatives implemented for promoting rational medicine use in children, the prevalence of off-label prescription in outpatient pediatric practice remains high.

KEYWORDS:

France; child; drug prescriptions; drug-related side effects and adverse reactions; outpatients; prospective studies

PMID:
25511119
DOI:
10.1542/peds.2014-0764
[Indexed for MEDLINE]
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