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Off-label prescribing patterns of antiemetics in children: a multicenter study in Italy

Davide Zanon1, Luca Gallelli, Francesca Rovere

  • 1Pharmacy, Institute for Maternal and Child Health, IRCCS Burlo Garofolo, Trieste, Italy.

European Journal of Pediatrics
|December 5, 2012
PubMed

Insights

Off-label antiemetic drug use is common in children with acute gastroenteritis (AG), especially in those under two years old. This practice poses safety risks and legal concerns for physicians treating pediatric vomiting.

Area of Science:

  • Pediatric Emergency Medicine
  • Clinical Pharmacology
  • Gastroenterology

Background:

  • Acute gastroenteritis (AG) is a primary cause of vomiting in young children, frequently leading to emergency department visits.
  • Pharmacological treatment for pediatric vomiting is controversial, with frequent off-label drug use regarding dosage, age, and indication.
  • Off-label prescribing involves using medications outside their approved guidelines.

Purpose of the Study:

  • To evaluate the off-label utilization of antiemetic medications in pediatric patients under 18 years old presenting with vomiting due to AG.
  • To identify specific antiemetics and the extent of their off-label application in this population.

Main Methods:

  • A retrospective study conducted across eight Italian pediatric emergency departments.
  • Data linkage between pharmacy distribution records and emergency department patient data.
  • Analysis included patient demographics (sex, age) and detailed drug information (indication, dose, frequency, route).

Main Results:

  • Antiemetic drugs were frequently prescribed, particularly for children up to two years old.
  • Approximately 30% of all administered antiemetics were used off-label.
  • Domperidone was the only antiemetic labeled for AG in pediatric patients; metoclopramide and ondansetron were used off-label for both age and indication (AG treatment).

Conclusions:

  • A significant proportion of antiemetics are used off-label in children with AG.
  • This practice raises patient safety concerns and potential legal risks for healthcare providers.
  • Standardizing antiemetic prescribing guidelines for pediatric AG is warranted.
Abstract

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