Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature

J Clin Pharm Ther. 2009 Jun;34(3):277-87. doi: 10.1111/j.1365-2710.2008.01005.x.


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.

Publication types

  • Review

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Drug Approval / legislation & jurisprudence*
  • Drug Labeling / legislation & jurisprudence*
  • Finland
  • Hospital Units / statistics & numerical data
  • Hospitals, University / statistics & numerical data
  • Humans
  • Infant
  • Infant, Newborn
  • Practice Patterns, Physicians' / legislation & jurisprudence
  • Practice Patterns, Physicians' / statistics & numerical data*
  • Prospective Studies