International Journal of Clinical Pharmacy

, Volume 38, Issue 4, pp 788–792 | Cite as

Maltese prescribers use of off-label and unlicensed medicines in children: perceptions and attitudes

  • Ian EllulEmail author
  • Victor Grech
  • Simon Attard-Montalto
Short Research Report


Background Reviews of paediatric prescriptions in the community setting have quantified off-label use to reach 52 % and unlicensed use to reach 17 %. Objective To investigate the attitudes and perceptions of a sample of paediatricians and family doctors practising in primary care on off-label and unlicensed prescribing in children in Malta. Methods A validated de novo 18-item questionnaire was used to conduct face-to-face, semi-structured interviews with 24 family doctors and 6 paediatricians during 2014. Results Although only 10 % of participants correctly defined off-label/unlicensed use, after the definitions were provided, 97 % admitted to knowingly prescribe medicines in this manner. Such use primarily involved prescribing to younger age groups and different indications to those recommended in the product literature. The main contributing factor for prescribing in an off-label/unlicensed manner was a lack of appropriately licensed paediatric medicines. The most commonly implicated class of medicines was cough/cold medicines. The principal concerns were medico-legal and safety concerns. Conclusion Participants knowingly prescribed medicines in an off-label/unlicensed manner. The perceived reasons were prescribing for a younger age and for indications outside the Summary of Product Characteristics. Divergent prescribing recommendations in different sources of information, prescribers’ personal experience and reliance on medical representatives contribute to inadvertent off-label/unlicensed prescribing.


Children Malta Off-label medicines Prescribers Unlicensed medicines 




Conflicts of interest

The authors declare that they have no conflict of interest.

Supplementary material

11096_2016_306_MOESM1_ESM.docx (21 kb)
Supplementary material 1 (DOCX 22 kb)


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Copyright information

© Springer International Publishing 2016

Authors and Affiliations

  • Ian Ellul
    • 1
    Email author
  • Victor Grech
    • 1
  • Simon Attard-Montalto
    • 1
  1. 1.Paediatrics DepartmentUniversity of MaltaMsidaMalta

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