title: Off-label and unlicensed utilization of drugs in a Brazilian pediatric hospital.
abstract: OBJECTIVE
  To describe the off-label and unlicensed utilization patterns of drugs in a Brazilian pediatric hospital.
  
  
  METHODS
  The research consisted of a descriptive, prospective and cross-sectional study.
  
  
  RESULTS
  A total of 1,158 medicines were prescribed for 320 patients, accounting for 65 different drugs. Regarding the classification of drug utilization, the majority of the drugs were prescribed as in-label (57.2%), followed by off-label (36.4%) and by unlicensed (6.3%). The prevalences of unlicensed and off-label utilization of drugs in the studied population were 20.9 and 77.8%, respectively. Polypharmacy was highly associated to both off-label and unlicensed regimen (OR 12.9; 95% CI 3.07-54.2 and OR 3.68; 95% CI 2.02-6.69, respectively) whereas preschool children were less prone to unlicensed prescription (OR 0.39; 95% CI 0.19-0.79). Sex and length of hospitalization were not related to these outcomes.
  
  
  CONCLUSIONS
  Further studies are necessary to verify the impact of this pattern on the occurrence of adverse drug events.
authors.affiliation: Faculdade de Ciências Farmacêuticas, Universidade Federal do Amazonas, Manaus, Amazonas.. imagalhaes@ufam.edu.br.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Pereira Gomes
authors.affiliation: Faculdade de Ciências Farmacêuticas, Universidade Federal do Amazonas, Manaus, Amazonas.. imagalhaes@ufam.edu.br.
authors.forename: Kédma
authors.initials: K
authors.lastname: Melo da Silva
authors.affiliation: Instituto de Saúde da Criança do Amazonas, Manaus, Amazonas. Brazil.. imagalhaes@ufam.edu.br.
authors.forename: Suely
authors.initials: S
authors.lastname: Oliveira Chagas
authors.affiliation: Faculdade de Ciências Farmacêuticas, Universidade Federal do Amazonas, Manaus, Amazonas.. imagalhaes@ufam.edu.br.
authors.forename: Igor Rafael
authors.initials: IR
authors.lastname: dos Santos Magalhães
mesh_terms: D000293:Adolescent; D000367:Age Factors; D001938:Brazil; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D006776:Hospitals, Pediatric / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D056687:Off-Label Use / Q000706:statistics & numerical data*; D011446:Prospective Studies