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

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.

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.

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.

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.

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.