In-label and off-label use of respiratory drugs in the Italian paediatric population

P. Baiardi, A. Ceci, M. Felisi, L. Cantarutti, S. Girotto, M. Sturkenboom, E. Baraldi

Research output: Contribution to journalArticlepeer-review

Abstract

Aim: To evaluate the prescription rate of respiratory drugs (ATC code R03) in an Italian community setting and to estimate the extent of off-label use by both age and indication. Methods: A cohort study aimed at evaluating prescriptions of drugs with ATC code R03 was conducted for the period 2002-2006. Data source was the PEDIANET Database. Results: Ninety percent of R03 prescriptions are covered by 11 active substances or combinations, corresponding to 67 medicinal products. Inhaled corticosteroids are the most prescribed anti-asthmatic agents, followed by short-acting β2 mimetics. The mean off-label rate is 19 and 56%, by age and indication respectively. The majority of off-label uses is among children under the age of 2. Five active substances are used at dosages not supported by adequate dose-finding studies. Conclusion: In Italy, many respiratory drugs are approved for the treatment of paediatric respiratory diseases, but a remarkable percentage of their prescriptions is off-label. This pharmaco-utilization study demonstrates that there is a need to perform clinical studies aimed at increasing the current knowledge on marketed paediatric drugs, and to revise and re-label the existing regulatory documents to reduce their off-label uses.

Original languageEnglish
Pages (from-to)544-549
Number of pages6
JournalActa Paediatrica, International Journal of Paediatrics
Volume99
Issue number4
DOIs
Publication statusPublished - Apr 2010

Keywords

  • Cohort study
  • Off-label
  • Paediatric population
  • Respiratory drugs

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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