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Drug Utilization and Off-label Drug Use in Spanish Pediatric Gastroenterology Outpatients

Ruíz-Antorán, Belén*; Piñeiro, Roi; Avendaño, Cristina*; Román, Enriqueta; Cilleruelo, María Luz; Gutiérrez-Junquera, Carolina; Centeno, Gustavo*; Cilleruelo, María José

Journal of Pediatric Gastroenterology & Nutrition: February 2013 - Volume 56 - Issue 2 - p 173–177
doi: 10.1097/MPG.0b013e3182566d92
Original Articles: Gastroenterology

Background and Objectives: The clinical use of medicines outside the conditions authorized in their Summary of Product Characteristics (SPC) (off-label use) is a common practice in pediatrics. The aim of the present study was to describe and quantify the medicines received by children attended in the pediatric gastroenterology department, their off-label use, and compliance with accepted rules for said use.

Methods: A retrospective observational study was performed on all of the patients who had their first consultation in pediatric gastroenterology between January 1 and October 31, 2010. All of the clinical information and medicines prescribed were analyzed. Off-label use was defined as the use of medicines in indications not included in the officially approved SPC or in ages not included or recommended in the SPC as well as the use of doses, intervals, or administration routes different from those considered in the SPC.

Results: A total of 695 patients (52.8% male) were included, 48.2% younger than 2 years. Two-hundred seven patients (29.8%) received 331 prescriptions. The most commonly used medicines were anti-H2 and proton pump inhibitors. Of all the prescriptions, 33.2% were considered off-label, and up to 47.3% of the prescribed patients had at least 1 medicine under off-label conditions. The medical records contained no documentation on information given to the parents regarding off-label use.

Conclusions: The study found a high percentage of off-label use of medicines in the Pediatric Gastroenterology outpatient setting, especially in children younger than 2 years. Several initiatives were derived from the present study and implemented in our hospital.

*Department of Clinical Pharmacology

Department of Pediatrics. Puerta de Hierro—Majadahonda University Hospital, Majadahonda, Madrid, Spain.

Address correspondence and reprint requests to Dr Roi Piñeiro Pérez, Department of Pediatrics. Puerta de Hierro—Majadahonda University Hospital, Manuel de Falla, 1, Majadahonda 28222, Spain (e-mail:

Received 26 February, 2012

Accepted 19 March, 2012

The authors report no conflicts of interest.

Copyright 2013 by ESPGHAN and NASPGHAN