title: 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).
  
  
  CONCLUSIONS
  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.
authors.forename: Ian C
authors.initials: IC
authors.lastname: Ellul
authors.forename: Victor
authors.initials: V
authors.lastname: Grech
authors.forename: Simon
authors.initials: S
authors.lastname: Attard-Montalto
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D017277:Drug Approval / Q000706:statistics & numerical data; D004363:Drug Utilization / Q000706:statistics & numerical data*; D005260:Female; D058005:General Practitioners / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008319:Malta; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010372:Pediatrics / Q000706:statistics & numerical data; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011320:Primary Health Care / Q000706:statistics & numerical data*; D011446:Prospective Studies
keywords: Children; general practice; off-label medicines; unlicensed medicines