title: Drug utilization and off-label drug use in Spanish pediatric gastroenterology outpatients.
abstract: OBJECTIVE
  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.
authors: Department of Clinical Pharmacology, Puerta de Hierro-Majadahonda University Hospital, Majadahonda, Madrid, Spain.
authors: Belén
authors: B
authors: Ruíz-Antorán
authors: Roi
authors: R
authors: Piñeiro
authors: Cristina
authors: C
authors: Avendaño
authors: Enriqueta
authors: E
authors: Román
authors: María Luz
authors: ML
authors: Cilleruelo
authors: Carolina
authors: C
authors: Gutiérrez-Junquera
authors: Gustavo
authors: G
authors: Centeno
authors: María José
authors: MJ
authors: Cilleruelo
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004348:Drug Labeling; D004363:Drug Utilization; D005260:Female; D005762:Gastroenterology / Q000379:methods*; D019983:Guideline Adherence; D006633:Histamine Antagonists / Q000627:therapeutic use*; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008499:Medical Records; D056687:Off-Label Use; D010353:Patient Education as Topic; D010372:Pediatrics / Q000379:methods*; D010818:Practice Patterns, Physicians'; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D012189:Retrospective Studies; D013030:Spain
chemical_list: D006633:Histamine Antagonists; D054328:Proton Pump Inhibitors