Off-label antibiotic use in children in three European countries.
OBJECTIVE
Antibiotics are the drugs most frequently prescribed for children, and most of them lack patent protection. The aim of this study was to evaluate off-label antibiotic use in three European countries.


METHODS
Data relating to all patients admitted to the neonatal intensive care units (NICUs) and paediatric wards of the participating centres were collected by the same investigator over a 2-week survey period between February and May 2009. The data included age, date of birth, weight, relevant medical history and diagnosis, together with details of all of the antibiotics prescribed (compound, route of administration, dose, and indication for use).


RESULTS
The study involved 616 children (110 admitted to NICUs: 62 in the UK, 38 in Italy and 10 in Greece; 506 admitted to general paediatric wards: 265 in the UK, 94 in Italy and 147 in Greece). A total of 1,244 antibiotic prescriptions were issued (290 in NICUs and 954 in paediatric wards). The results showed that off-label antibiotic use is very common among European paediatric patients, with generally only slight, but sometimes significant differences between countries. However, this use relates almost exclusively to doses and indications, and rarely to age. The only antibiotics found to be used off-label in an age-related manner in paediatric clinical practice are meropenem for neonates and quinolones or linezolid for older children, which represent priorities for future studies.


CONCLUSIONS
European-wide educational programmes are urgently needed to meet the objectives of improving paediatricians' working knowledge of the recommendations surrounding licensed antibiotics-use in children, and of reducing uncontrolled patterns of prescribing.
Department of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena", Via Commenda 9, 20122 Milan, Italy.
Alessandro
A
Porta
Susanna
S
Esposito
Esse
E
Menson
Nikos
N
Spyridis
Maria
M
Tsolia
Mike
M
Sharland
Nicola
N
Principi
D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006115:Greece; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007558:Italy; D008297:Male; D056687:Off-Label Use; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D006113:United Kingdom
D000900:Anti-Bacterial Agents