Drug utilisation pattern and off-label use of medicines in Estonian neonatal units

Eur J Clin Pharmacol. 2011 Dec;67(12):1263-71. doi: 10.1007/s00228-011-1072-x. Epub 2011 Jun 11.


Objectives: To characterise neonatal hospital drug use and to compare the availability of drug information between Estonian Summaries of Product Characteristics (SPCs) and other sources.

Study design: This was a prospective cohort study in which pharmacotherapy information on neonates admitted to Tartu University Clinics between 1 February and 1 August 2008 and to Tallinn Children's Hospital between 1 February and 1 August 2009 was collected. Drug labelling status was determined according to Estonian SPCs, and neonatal information was compared with the British National Formulary for Children (BNFC) and the Thomson Micromedex database.

Results: Of 490 hospitalised neonates, 71% received pharmacotherapy. Within the entire study period, there were 1981 prescriptions for 115 products, with a median of four (interquartile range 2-7) products per child. Antibacterial, cardiovascular and central nervous system drugs were the most commonly prescribed. All treated preterm neonates received at least one unlicensed or age-related off-label prescription. All prescriptions for alimentary, genitourinary, musculoskeletal and sensory system drugs were off-label. There were large differences in the neonatal information provided by the different sources, with the largest differences found for term neonates, for whom the information was available for 67, 38 and 24% of prescriptions according to the BNFC, Micromedex and Estonian SPC, respectively.

Conclusions: The high rate of age-related off-label prescribing for neonates calls for urgent action from medical professionals and others to reinforce effective and safe pharmacotherapy for this age group. The existing SPCs should be regularly updated and more closely harmonised to each other.

MeSH terms

  • Drug Labeling
  • Drug Utilization / statistics & numerical data*
  • Estonia
  • Female
  • Hospitals, Pediatric / statistics & numerical data
  • Hospitals, University / statistics & numerical data
  • Humans
  • Infant, Newborn
  • Intensive Care Units, Neonatal / statistics & numerical data*
  • Male
  • Off-Label Use / statistics & numerical data*