title: Off-label and unlicensed paediatric prescribing in a community setting: a prospective longitudinal cohort study in Malta.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors: Ian C
authors: IC
authors: Ellul
authors: Victor
authors: V
authors: Grech
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008137:Longitudinal Studies; D008297:Male; D008319:Malta; D056687:Off-Label Use / Q000706:statistics & numerical data*; D011446:Prospective Studies
keywords: Children,; General practice,; Medicinal products,; Off-label prescribing,; Unlicensed prescribing