Advertisement

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

Abstract

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.

Keywords

Children Malta Off-label medicines Prescribers Unlicensed medicines 

Notes

Funding

None.

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)

References

  1. 1.
    Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr. 2005;164:552–8.CrossRefPubMedGoogle Scholar
  2. 2.
    Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf. 2006;5:703–18.CrossRefPubMedGoogle Scholar
  3. 3.
    Kimland E, Odlind V. Off-label drug use in pediatric patients. Clin Pharmacol Ther. 2012;91(5):796–801.CrossRefPubMedGoogle Scholar
  4. 4.
    Ellul IC, Grech V, Attard-Montalto S. Paediatric off-label and unlicensed prescribing in primary care in Malta: prospective observational drug utilisation study. Int J Risk Saf Med. 2015;27(3):123–34.CrossRefPubMedGoogle Scholar
  5. 5.
    Ekins-Daukes S, Helms PJ, Taylor MW, McLay JS. Off-label prescribing to children: attitudes and experience of general practitioners. Br J Clin Pharmacol. 2005;60(2):145–9.CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    McLay JS, Tanaka M, Ekins-Daukes S, Helms PJ. A prospective questionnaire assessment of attitudes and experiences of off label prescribing among hospital based paediatricians. Arch Dis Child. 2006;91:584–7.CrossRefPubMedPubMedCentralGoogle Scholar
  7. 7.
    Marchetti F, Bua J, Ventura A, Notarangelo LD, Di Maio S, Migliore G, et al. The awareness among paediatricians of off-label prescribing in children: a survey of Italian hospitals. Eur J Clin Pharmacol. 2007;63:81–5.CrossRefPubMedGoogle Scholar
  8. 8.
    Mukattash TL, Wazaify M, Khuri-Boulos N, Jarab A, Hawwa AF, McElnay JC. Perceptions and attitudes of Jordanian paediatricians towards off-label paediatric prescribing. Int J Clin Pharm. 2011;33(6):964–73.CrossRefPubMedGoogle Scholar
  9. 9.
    Piñeiro-Pérez R, Ruiz Antorán MB, Avendaño Solá C, Román Riechmann E, Cabrera García L, Cilleruelo Ortega MJ, et al. Results from the 2012–2013 paediatric national survey on off-label drug use in children in Spain (OL-PED study). An Pediatr (Barc). 2014;81(1):16–21.CrossRefPubMedGoogle Scholar
  10. 10.
    Chisholm A. Exploring UK attitudes towards unlicensed medicines use: a questionnaire-based study of members of the general public and physicians. Int J Gen Med. 2012;5:27–40.PubMedPubMedCentralGoogle Scholar
  11. 11.
    Mukattash T, Hawwa AF, Trew K, McElnay JC. Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials. Eur J Clin Pharmacol. 2011;67(5):449–61.CrossRefPubMedGoogle Scholar
  12. 12.
    Carnovale C, Conti V, Perrone V, Antoniazzi S, Pozzi M, Merlino L, et al. Paediatric drug use with focus on off-label prescriptions in Lombardy and implications for therapeutic approaches. Eur J Pediatr. 2013;172(12):1679–85.CrossRefPubMedGoogle Scholar
  13. 13.
    Bua J, L’Erario I, Barbi E, Marchetti F. When off-label is a good practice: the example of paracetamol and salbutamol. Arch Dis Child. 2008;93:546–7.CrossRefPubMedGoogle Scholar

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

Personalised recommendations