Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature
Article first published online: 19 JAN 2009
© 2009 The Authors. Journal compilation © 2009 Blackwell Publishing Ltd
Journal of Clinical Pharmacy and Therapeutics
Volume 34, Issue 3, pages 277–287, June 2009
How to Cite
Lindell-Osuagwu, L., Korhonen, M. J., Saano, S., Helin-Tanninen, M., Naaranlahti, T. and Kokki, H. (2009), Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. Journal of Clinical Pharmacy and Therapeutics, 34: 277–287. doi: 10.1111/j.1365-2710.2008.01005.x
- Issue published online: 5 MAY 2009
- Article first published online: 19 JAN 2009
- Received 9 November 2007, Accepted 31 August 2008
Objectives: In paediatric pharmacotherapy, many drugs are prescribed to be given in ways and for conditions not approved in the marketing authorization (MA). Thus, off-label prescribing of drugs with no MA is widespread in paediatric wards. However, drug MA status and clinical practices differ across countries. In this prospective study, we studied the prescribing of off-label and unlicensed drugs in three paediatric wards in a tertiary hospital in Finland. Furthermore, we reviewed previous published studies to provide an up-to-date international perspective on prescribing of off-label and unlicensed drugs for hospitalized children.
Methods: During a 2-week period, prescriptions for patients under 18 years of age (median age 1·6 years) in three wards; neonatal intensive care unit (NICU), general paediatric ward and paediatric surgical ward were recorded daily and drug-licensing status of all prescriptions was determined according to the approved summary of product characteristics. Published studies were retrieved through electronic searches, including MEDLINE (PubMed).
Results: Of the 141 children, 108 received 629 prescriptions. Of the 108 children with a prescription, 82 (76%) had at least one off-label or unlicensed drug prescribed; 79% in the NICU, 63% in the general ward and 91% in the surgical ward (P = 0·014). Of the 108 children with a prescription, 26 (24%) received prescriptions for licensed drugs, 71 (66%) received prescriptions off-label and 36 (33%) for unlicensed drugs. Of all 629 prescriptions, 321 (51%) were for licensed drugs, 226 (36%) for off-label and 82 (13%) for unlicensed drugs. International studies showed similar extents of off-label and unlicensed-drug prescribing.
Conclusion: This study indicates that the use of off-label and unlicensed drugs is widespread in all the different paediatric wards surveyed and was as extensive as those reported for other countries.