European Journal of Clinical Pharmacology

, Volume 71, Issue 1, pp 1–13 | Cite as

Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review

  • Joana Magalhães
  • António Teixeira Rodrigues
  • Fátima Roque
  • Adolfo Figueiras
  • Amílcar Falcão
  • Maria Teresa Herdeiro
Review Article



The aim of this review is to assess the extent of the use of off-label and/or unlicenced drugs among hospitalised children.


A systematic search was made in MEDLINE-PubMED for papers published from 1994 to 2012, addressing the prescription of off-label and/or unlicenced drugs for the paediatric population in hospital care.


Of the 829 studies retrieved, 34 met the inclusion criteria. Prescriptions ranged from 12.2 to 70.6 % for off-label and from 0.2 to 47.9 % for unlicensed drugs. The percentage of children who received at least one off-label and/or unlicensed drug ranged from 42.0 to 100 %, with newborns being the population that received most of such drugs. Off-label prescriptions were essential for dose modification (7.1–73.1 %) and unlicensed prescriptions for formulation modification purposes (3.6–100 %).


These findings show that: (i) off-label and/or an unlicensed prescribing is widespread among the hospitalised paediatric population worldwide, (ii) there is no consensus on a definition of off-label and/or unlicensed drugs and (iii) preterm newborns receive most off-label and/or unlicensed drugs. By shedding new light on off-label and/or unlicensed drug prescribing, these findings will hopefully contribute to generating new, more effective knowledge about the paediatric population’s need for quality drugs that are both safe and efficacious.


Paediatric Unlicensed Off-label Drug Hospital care 


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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Joana Magalhães
    • 1
    • 2
  • António Teixeira Rodrigues
    • 1
    • 2
  • Fátima Roque
    • 1
    • 3
  • Adolfo Figueiras
    • 4
    • 5
  • Amílcar Falcão
    • 2
    • 6
  • Maria Teresa Herdeiro
    • 1
    • 7
  1. 1.Centre for Cell BiologyUniversity of Aveiro (CBC/UA)AveiroPortugal
  2. 2.Faculty of Pharmacy, Health Sciences CampusUniversity of CoimbraCoimbraPortugal
  3. 3.Research Unit for Inland DevelopmentPolytechnic Institute of Guarda(UDI/IPG)GuardaPortugal
  4. 4.University of Santiago de CompostelaSantiago de CompostelaSpain
  5. 5.Consortium for Biomedical Research in Epidemiology & Public Health (CIBER en Epidemiología y Salud Pública—CIBERESP)MadridSpain
  6. 6.Centre for Neuroscience and Cell BiologyUniversity of Coimbra (CNC/UC)CoimbraPortugal
  7. 7.CESPUInstituto de Investigação e Formação Avançada em Ciências e Tecnologias da SaúdeGandraPortugal

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