Abstract 265 Poster Session III, Monday, 5/3 (poster 94)

In paediatric practice, drugs are often prescribed that are either unlicensed for use in children or are prescribed outside the terms of the product license ("off-label"). There is however little information available on the extent to which these types of treatment are used. We therefore studied unlicensed drug use prospectively. Prescriptions for all patients hospitalised to 59 French neonatal and paediatric intensive care units over a 24 hours period were reviewed. Each drug was assessed according to the French product licence. 2383 courses of drugs were administered to 588 patients (4.6/patient). 49.6% of the patients were less than 1 month. 40.2 were premature. 65% of the drug courses (prescriptions) were unlicenced for use in children and 13%, 28%, 9% were off-label in relation respectively with the dose, the indication and the route of administration. 73% were unlicenced or off-label for more than 1 reason. The total of unlicensed for age and off-label prescriptions were 94%. The 10 most frequently administered unlicensed or off-label drugs were caffeine citrate, midazolam, fentanyl, cefotaxime, furosemide, propacetamol, amoxicilline, amikacin, vancomycin, domperidone. The percentage of unlicensed and off-label drug prescriptions decreased with increasing age. There is no specific paediatric dosage for 73% of the prescriptions. In conclusion, many of the drugs extensively prescribed in French neonatal and paediatric intensive care are not evaluated by the licensing authority.

Groupe de pharmacologie Perinatale et Pediatrique