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

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Abstract

Purpose

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

Methods

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.

Results

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 %).

Conclusions

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.

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Acknowledgements

Author FR wish to  thank to UDI/IPG and to the Foundation for Science and Technology (FCT) [Pest-OE/EGE/UI4056/2014], and author AF to the Health Research Fund (Fondo de Investigación Sanitaria) [PI12/02414 y PI081239].

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Authors and Affiliations

  1. Centre for Cell Biology, University of Aveiro (CBC/UA), Aveiro, Portugal

    Joana Magalhães, António Teixeira Rodrigues, Fátima Roque & Maria Teresa Herdeiro

  2. Faculty of Pharmacy, Health Sciences Campus, University of Coimbra, Coimbra, Portugal

    Joana Magalhães, António Teixeira Rodrigues & Amílcar Falcão

  3. Research Unit for Inland Development, Polytechnic Institute of Guarda(UDI/IPG), Guarda, Portugal

    Fátima Roque

  4. University of Santiago de Compostela, Santiago de Compostela, Spain

    Adolfo Figueiras

  5. Consortium for Biomedical Research in Epidemiology & Public Health (CIBER en Epidemiología y Salud Pública—CIBERESP), Madrid, Spain

    Adolfo Figueiras

  6. Centre for Neuroscience and Cell Biology, University of Coimbra (CNC/UC), Coimbra, Portugal

    Amílcar Falcão

  7. CESPU, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde, Rua Central de Gandra, 1317, 4585-116, Gandra, PRD, Portugal

    Maria Teresa Herdeiro

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  1. Joana Magalhães
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  2. António Teixeira Rodrigues
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Correspondence to Maria Teresa Herdeiro.

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Magalhães, J., Rodrigues, A.T., Roque, F. et al. Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review. Eur J Clin Pharmacol 71, 1–13 (2015). https://doi.org/10.1007/s00228-014-1768-9

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  • DOI: https://doi.org/10.1007/s00228-014-1768-9

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