European Journal of Pediatrics

, Volume 172, Issue 3, pp 361–367

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

  • Davide Zanon
  • Luca Gallelli
  • Francesca Rovere
  • Rossella Paparazzo
  • Natalia Maximova
  • Marzia Lazzerini
  • Antonio Reale
  • Tiziana Corsetti
  • Salvatore Renna
  • Tullia Emanueli
  • Francesco Mannelli
  • Francesco Manteghetti
  • Liviana Da Dalt
  • Caterina Palleria
  • Nicola Banchieri
  • Antonio Urbino
  • Mario Miglietta
  • Giovanni Cardoni
  • Adriana Pompilio
  • Alberto Arrighini
  • Clara Lazzari
  • Gianni Messi
Original Article

DOI: 10.1007/s00431-012-1894-2

Cite this article as:
Zanon, D., Gallelli, L., Rovere, F. et al. Eur J Pediatr (2013) 172: 361. doi:10.1007/s00431-012-1894-2

Abstract

Acute gastroenteritis (AG) represents both the main cause of acute vomiting in children under 3 years old and a major cause of access to the emergency department. Even if several drugs may be able to reduce the emesis, the pharmacological treatment of vomiting in children remains a controversial issue, and several drugs are prescribed outside their authorized drug label with respect dosage, age, indication, or route of administration and are named as off-label. The aim of present study was to assess the off-label use of antiemetic drugs in patients less than 18 years with vomiting related to AG. This study was carried out in eight pediatric emergency departments in Italy. The following data were obtained crossing the pharmacy distribution records with emergency departments’ patient data: sex and age of the patients and detailed information for each drug used (indication, dose, frequency, and route of administration). We recorded that antiemetic drugs were prescribed in every year, particularly in children up to 2 years old, and compared with both literature data and data sheet; 30 % of the administered antiemetics were used off-label. In particular, domperidone was the only antiemetic used labeled for AG treatment in pediatric patients, while metoclopramide and ondansetron have been off-label for both age and indications (i.e., AG treatment). Conclusions: In conclusion, we documented an off-label use of antiemetics in children, and this could represents a problem of safety for the patient and a legal risk for the prescribing physician if patients have an unwanted or bad outcome from treatment.

Keywords

AntiemeticsChildrenOff-labelPrescriptions

Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • Davide Zanon
    • 1
  • Luca Gallelli
    • 2
  • Francesca Rovere
    • 1
  • Rossella Paparazzo
    • 1
  • Natalia Maximova
    • 3
  • Marzia Lazzerini
    • 4
  • Antonio Reale
    • 5
  • Tiziana Corsetti
    • 6
  • Salvatore Renna
    • 7
  • Tullia Emanueli
    • 8
  • Francesco Mannelli
    • 9
  • Francesco Manteghetti
    • 10
  • Liviana Da Dalt
    • 11
  • Caterina Palleria
    • 2
  • Nicola Banchieri
    • 12
  • Antonio Urbino
    • 13
  • Mario Miglietta
    • 14
  • Giovanni Cardoni
    • 15
  • Adriana Pompilio
    • 16
  • Alberto Arrighini
    • 17
  • Clara Lazzari
    • 18
  • Gianni Messi
    • 4
  1. 1.PharmacyInstitute for Maternal and Child Health, IRCCS Burlo GarofoloTriesteItaly
  2. 2.Clinical Pharmacology Unit, Department of Health Science, School of MedicineUniversity of Catanzaro, Mater Domini University HospitalCatanzaroItaly
  3. 3.Department of Paediatric Onco-ematologyInstitute for Maternal and Child Health, IRCCS Burlo GarofoloTriesteItaly
  4. 4.Paediatric Emergency DepartmentInstitute for Maternal and Child Health, IRCCS Burlo GarofoloTriesteItaly
  5. 5.Paediatric Emergency DepartmentChildren’s Hospital Bambino Gesù, IRCCSRomeItaly
  6. 6.PharmacyChildren’s Hospital Bambino Gesù, IRCCSRomeItaly
  7. 7.Paediatric Emergency DepartmentIstituto Giannina GasliniGenovaItaly
  8. 8.PharmacyIstituto Giannina GasliniGenovaItaly
  9. 9.Department of Pediatric Emergency MedicineAnna Meyer Pediatric HospitalFlorenceItaly
  10. 10.PharmacyAnna Meyer Pediatric HospitalFlorenceItaly
  11. 11.Department of PediatricsUniversity of PaduaPaduaItaly
  12. 12.PharmacyAzienda Ospedaliera of PaduaPaduaItaly
  13. 13.Department of Pediatric EmergencyRegina Margherita Children’s HospitalTurinItaly
  14. 14.PharmacyO.I.R.M. Sant’ AnnaTurinItaly
  15. 15.Paediatric Emergency DepartmentSalesi Children’s Hospital of AnconaAnconaItaly
  16. 16.PharmacySalesi Children’s Hospital of AnconaAnconaItaly
  17. 17.Paediatric Emergency DepartmentChildren’s Hospital of BresciaBresciaItaly
  18. 18.PharmacySpedali Civili Hospital of BresciaBresciaItaly