Off label use of prescription medicines in children in outpatient setting in Estonia is common

Pharmacoepidemiol Drug Saf. 2011 May;20(5):474-81. doi: 10.1002/pds.2125.


Purpose: We aimed to analyse the availability of paediatric information in Summaries of Product Characteristics (SPC) of ambulatory prescription medicines used in children and to compare the SPC information with other information sources.

Methods: In a cross-sectional drug utilisation study based on national prescription database, we analysed all dispensed prescriptions to subjects of <19 years in 2007. We reviewed SPCs of drugs for paediatric information and categorised them as being labelled, off-label and unlicensed.

Results: Of 467,334 prescriptions dispensed to 151, 476 children, 69% were for labelled, 31% for off-label and 0.05% for unlicensed drugs. The proportion of prescriptions for drugs being off-label because of missing data was the highest in genitourinary group (97%) and dermatologicals (74%); off-label use because of contraindication in the musculoskeletal group (69%). The highest proportion of off-label drugs was among children aged less than 2 years and the lowest for 2-6-year-olds. Contraindicated medicines were most often prescribed to adolescents. Systemic drugs were more frequently prescribed according to the label than topical agents. SPCs were found often not to be comparable with the other information sources.

Conclusions: We show that one-third of Estonian children treated with prescription medicines are exposed to drugs not labelled for paediatric use. We believe that this is not only partly due to the limited number of paediatric trials but also due to lack of up-to-date information in the SPCs. We suggest that paediatric information should be regularly updated in SPCs to ensure that it is based on the best currently available evidence.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Ambulatory Care / methods*
  • Ambulatory Care / standards
  • Child
  • Cross-Sectional Studies
  • Drug Utilization Review / statistics & numerical data*
  • Estonia
  • Humans
  • Off-Label Use / statistics & numerical data*
  • Pediatrics / standards
  • Pediatrics / statistics & numerical data*
  • Prescription Drugs / administration & dosage*
  • Prescription Drugs / therapeutic use


  • Prescription Drugs