Objectives: Many drugs used in paediatric care are not licensed for that use or are prescribed outside the terms of the product license (off-label). Studies in the UK and Europe showed a large number of unlicensed and off-label drug prescription in specialised paediatric health care centres. We determined the extent and nature of use of unlicensed drugs and off-label prescriptions in children in a general hospital in the Netherlands. Method: We conducted a longitudinal prospective cohort study in a dynamic population consisting of patients admitted to the paediatric ward and the neonatology unit of a general hospital during a 19-week period. Drug-licensing status of all prescriptions given to these patients was determined. Results: A total of 1017 prescriptions was administered to 293 paediatric patients for 114 different drugs. The median number of prescriptions per patient was three (interquartile range 2-5). The most commonly administered drugs were acetaminophen (14%), cefotaxime (8%), amoxicillin (7%), caffeine (4%) and prednisolone (4%). Four hundred and forty-three (44%) prescriptions were off-label, and 285 (28%) were for unlicensed drugs. Ninety-two percent of patients received one or more unlicensed or off-label prescriptions, and this proportion was significantly higher in children below 6 months of age than in older children. Conclusions: This study shows that the extent of unlicensed and off-label drug prescription in a paediatric ward and neonatology unit of a general hospital is large and not smaller than in an academic paediatric setting. Lack of paediatric drug labelling is therefore not solely a problem with drugs used in university hospitals, but also in general hospitals. Efforts must be taken to change the current situation.

Additional Metadata
Keywords Children, EMEA, Licensing
Persistent URL dx.doi.org/10.1007/s00228-002-0479-9, hdl.handle.net/1765/67214
Journal European Journal of Clinical Pharmacology
't Jong, G.W, van der Linden, P.D, van den Beukel-Bakker, E.M, van der Lely, N, Eland, I.A, Stricker, B.H.Ch, & van den Anker, J.N. (2002). Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands. European Journal of Clinical Pharmacology, 58(4), 293–297. doi:10.1007/s00228-002-0479-9