Off-label and Unlicensed Use of Medicines in Children. A Case Study for Malta

      Аннотация: In Malta, off-label prescribing in children stands at 45%, primarily due to the failure by doctors to follow the dosing recommendations in the product literature of medicines. Registration procedures of pharmaceuticals may also inadvertently contribute to this high incidence of off-label prescribing. In Malta, the registration procedures 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 variances in the product literature, having the same active ingredients but imported from different countries, may cause divergent prescribing practices, leading to inadvertent off-label use. As such, off-label prescribing does not necessarily mean that safety and efficacy data are unavailable. The various stakeholders, including member states, should devise strategies to harmonize the most recent labelling information in order to support the safe and effective use of paediatric medicines.

Ключевые слова: Children, Off-label prescribing, Unlicensed prescribing, Article 126a, Regulatory affairs