title: [High prevalence of off-label and unlicensed drug prescribing in a Brazilian intensive care unit].
abstract: OBJECTIVE
  To describe the use and determine the prevalence of off-label and unlicensed drug use prescribing in a pediatric intensive care unit in a Southeastern Brazilian hospital
  
  
  METHODS
  Cross-sectional study of inpatients in a pediatric intensive care unit from May 2008 through January 2009. The classification according to the Brazilian regulatory agency (Agência de Vigilância Sanitária - Anvisa) approval criteria was based on the Anvisa electronic package insert list, Pharmaceuticals Dictionary, and the analysis was conducted through R software.
  
  
  RESULTS
  We analysed 1,054 prescription items for 73 patients. Females predominated (52%), and the patients' age ranged from 0 to 16 years. Among the prescribed items, 23.4% were off-label, 12.6% were unlicensed, 1.4% were both off-label and unlicensed, 86% had at least one item off-label, and 67% had at least one unlicensed drug. The most frequently prescribed therapeutic groups were systemic anti-bacterial, analgesic, psycholeptic, and antiasmathic agents.
  
  
  CONCLUSIONS
  The current study results confirm the high prevalence of unlicensed and off-label drug use in a pediatric intensive care unit.
authors.affiliation: Departamento de Ciências Farmacêuticas, Faculdade de Patos de Minas, Patos de Minas, MG, Brasil. 　lyabreu@hotmail.com
authors.forename: Lilian de Abreu
authors.initials: Lde A
authors.lastname: Ferreira
authors.forename: Cássio da Cunha
authors.initials: Cda C
authors.lastname: Ibiapina
authors.forename: Márcia Gomes Penido
authors.initials: MG
authors.lastname: Machado
authors.forename: Eleonora Druve Tavares
authors.initials: ED
authors.lastname: Fagundes
mesh_terms: D000293:Adolescent; D001938:Brazil; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007362:Intensive Care Units / Q000706:statistics & numerical data*; D008297:Male; D056687:Off-Label Use / Q000706:statistics & numerical data*