title: Maltese prescribers use of off-label and unlicensed medicines in children: perceptions and attitudes.
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.
authors.affiliation: Paediatrics Department, University of Malta, Msida, Malta. ian.c.ellul@gmail.com.
authors.forename: Ian
authors.initials: I
authors.lastname: Ellul
authors.affiliation: Paediatrics Department, University of Malta, Msida, Malta.
authors.forename: Victor
authors.initials: V
authors.lastname: Grech
authors.affiliation: Paediatrics Department, University of Malta, Msida, Malta.
authors.forename: Simon
authors.initials: S
authors.lastname: Attard-Montalto
mesh_terms: D017277:Drug Approval; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008319:Malta; D056687:Off-Label Use / Q000706:statistics & numerical data*; D000072143:Pediatricians / Q000523:psychology*; D058007:Physicians, Primary Care / Q000523:psychology*
keywords: Children; Malta; Off-label medicines; Prescribers; Unlicensed medicines