Contributing factors for the high rates of OL and UL prescribing include failure by prescribers to follow recommendations detailed in the product literature and a lack of licensed paediatric medicines.

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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.

Background: In Malta, off-label prescribing of medicines in children stands at 45%, mainly because of failure by prescribers to follow the dosing recommendations in the product literature. In addition, registration procedures of pharmaceuticals may inadvertently contribute to this high incidence of off-label prescribing. Methods: A literature review was conducted to identify regulatory provisions relating to the registration of medicines in Malta that could give rise to off-label use. Furthermore, the product literature of the 2 classes of medicines most commonly prescribed in children, antibiotics and respiratory medicines, were reviewed. This was done in order to gauge whether the different registration routes implemented in Malta to market these medicines could give rise to off-label use. Results: The national registration procedure relating to Article 126a of Directive 2001/83/EC and, to a lesser extent, line extensions, parallel importation, and the provision detailed in Article 11 of Directive 2001/83/EC were found to lead to discrepancies and potentially misleading inclusions in the product literature. These, in turn, may well contribute to off-label use of medicines in children. Conclusions: Off-label prescribing does not necessarily mean that efficacy and safety data are unavailable. Variances in the product literature of medicines having the same active ingredients but imported from different countries may cause divergent prescribing practices, leading to inadvertent off-label use. The various stakeholders, including member states such as Malta, should devise strategies to harmonize the most recent labeling information in order to support the safe and effective use of pediatric medicines, thereby decreasing off-label use.