title: Off-label prescribing patterns of antiemetics in children: a multicenter study in Italy.
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.
authors.affiliation: Pharmacy, Institute for Maternal and Child Health, IRCCS Burlo Garofolo, Trieste, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Zanon
authors.forename: Luca
authors.initials: L
authors.lastname: Gallelli
authors.forename: Francesca
authors.initials: F
authors.lastname: Rovere
authors.forename: Rossella
authors.initials: R
authors.lastname: Paparazzo
authors.forename: Natalia
authors.initials: N
authors.lastname: Maximova
authors.forename: Marzia
authors.initials: M
authors.lastname: Lazzerini
authors.forename: Antonio
authors.initials: A
authors.lastname: Reale
authors.forename: Tiziana
authors.initials: T
authors.lastname: Corsetti
authors.forename: Salvatore
authors.initials: S
authors.lastname: Renna
authors.forename: Tullia
authors.initials: T
authors.lastname: Emanueli
authors.forename: Francesco
authors.initials: F
authors.lastname: Mannelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Manteghetti
authors.forename: Liviana
authors.initials: L
authors.lastname: Da Dalt
authors.forename: Caterina
authors.initials: C
authors.lastname: Palleria
authors.forename: Nicola
authors.initials: N
authors.lastname: Banchieri
authors.forename: Antonio
authors.initials: A
authors.lastname: Urbino
authors.forename: Mario
authors.initials: M
authors.lastname: Miglietta
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cardoni
authors.forename: Adriana
authors.initials: A
authors.lastname: Pompilio
authors.forename: Alberto
authors.initials: A
authors.lastname: Arrighini
authors.forename: Clara
authors.initials: C
authors.lastname: Lazzari
authors.forename: Gianni
authors.initials: G
authors.lastname: Messi
mesh_terms: D000293:Adolescent; D000932:Antiemetics / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data; D005759:Gastroenteritis / Q000150:complications*; D006776:Hospitals, Pediatric / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007558:Italy; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D012189:Retrospective Studies; D014839:Vomiting / Q000188:drug therapy* / Q000209:etiology
chemical_list: D000932:Antiemetics