Background The availability of drugs specifically assessed for use in neonates is limited as evaluation is more difficult in neonates than in adults. The result is a widespread off-label use of drugs, especially in neonatal intensive care units. Such practise is an essential part of their care and should be based on the best available evidence.
Purpose To describe and analyse the off-label use of medicines in a neonatal intensive care unit.
Materials and Methods Prospective observational study conducted over three months, from 27 February 2012 to 27 May 2012. All the drugs prescribed were analysed with regard to their licence status for the: indication, dose, route of administration, mode of administration, age category, formulation (compounding of capsules, oral suspensions, eye drops), contraindications and warnings specified in the summary of product characteristics of the marketing authorization.
Results In total, 638 prescriptions, comprising 59 different medicines were written, 107 newborn babies were admitted (60 male, 47 female). Their age varied from 0 to 27 days (average: 2 days), their mean gestational age was of 34 weeks of amenorrhea (65% premature), their weight ranged from 630 g to 4700 g (average: 2230 g). A total of 487 prescriptions were written off-label (76%), with 101 patients (94%) receiving at least one drug used off-label. Drugs were prescribed off-label mostly concerning the indication (48%), then came off-label use for the dose and the age category. The medicine most often prescribed off-label was caffeine citrate.
Conclusions Critically ill neonates are exposed to numerous medicines, a significant proportion of which are not yet approved for use in this vulnerable group of patients. Despite European initiatives aiming to promote greater awareness and research in the paediatric population, there is still a high percentage of unlicensed or off-label drug use in neonatal intensive care. This study underlines the need for clinical research and approval of the clinical data acquired within the neonatal population.
No conflict of interest.
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