Paediatric off-label and unlicensed prescribing in primary care in Malta : prospective observational drug utilisation study

Abstract

OBJECTIVE: To investigate the incidence of off-label (OL) and unlicensed (UL) prescribing to children in primary care in Malta. METHODS: A prospective pharmaco-epidemiological review of 1507 medicines recommended to 924 children by both paediatricians and general practitioners was conducted. OL medicines were defined as medicines that were not prescribed in accordance with their Summary of Product Characteristics (SmPC) with respect to age, dose and indication as well as frequency, duration and route of administration. UL medicines were defined as medicines that did not have a marketing authorisation, as well as medicines whose formulation was modified. RESULTS: 721 from 1507 medicines (47.8% ) were prescribed in an OL/UL manner, the highest incidence in the 1 month –2 years age range (210 from 345 medicines; 60.9% ). More paediatricians rather than family doctors prescribed in an UL (11.6% vs 3.6% , p < 0.001) and OL manner for age (25.7% vs 19.6% , p < 0.001). Conversely, more family doctors rather than paediatricians prescribed in an OL manner for dose (33.5% vs 21.4% , p < 0.001). CONCLUSION: 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.