Off-label and unlicensed paediatric prescribing in a community setting: a prospective longitudinal cohort study in Malta

Background: In children, the incidence of off-label prescriptions in primary care varies between 10.5% and 22.7%, whilst the incidence of unlicensed prescriptions in primary care varies between 0.3% and 16.6%. This information has not been investigated in Malta. Objective: To identify therapeutic areas which warrant research in children in the community setting in Malta according to the proportion and nature of off-label and unlicensed medicinal use. Methods: Interim analysis involving the assessment of prescriptions for children in a prospective pharmaco-epidemiological study. Data regarding prescriptions in 37 private clinics and pharmacies attended by paediatricians and family doctors were collected for a cohort of 209 patients aged 0-14 years. The medicines were categorised as licensed, unlicensed or off-label. They were also classified into various categories such as patient age-group, data collection period, prescriber type and Anatomical Therapeutic Chemical classification system. Results: 113 of 209 (54.1%) medicinal products were used in an off-label and unlicensed manner, the highest number being in the 2-11-years age range (76/209). The majority of drugs were for the respiratory system. The proportion off-label drug prescribing because of age decreased progressively with increasing age whilst the proportion off-label prescribing because of dose increased with age. Conclusion: The main cause of off-label prescribing appears to be a failure to adhere to licensed dose recommendations and a lack of agreement between the existing literature and drug licences.