title: [Prescription of drugs not appropriate for children in a Pediatric Intensive Care Unit].
abstract: OBJECTIVE
  To assess the extent of use of drugs not appropriate for children in prescriptions issued in a tertiary pediatric intensive care unit (PICU), according to FDA standards.
  
  
  METHODS
  Observational cross-sectional study. The prescriptions issued to all patients admitted to the PICU at Hospital de Clínicas de Porto Alegre, Brazil, over a six-week period were assessed. Patients' age, sex, weight, prior disease, reason for admission to the PICU and pediatric index of mortality (PIM) were recorded, as were all drugs prescribed, their indications, presentations, doses, frequencies and means of administration. Adequacy for prescription of drugs in three pediatric age ranges was defined according to USA Food and Drug Administration (FDA) approval classification, based on the USP DI 2001 drug reference database.
  
  
  RESULTS
  Data were obtained in the months of July and August 2002, on different days, for six consecutive weeks, based on prescriptions issued to 51 patients in 54 admissions to the PICU. Median patient age was 10.5 months; 61% of patients were male. Two thirds of patients (65%) presented prior disease. 87% of admissions were due to clinical reasons, of which 57% were respiratory complaints. A total of 747 prescription items were registered, with prevalence of 10.5% for non-approved uses and 49.5% for off-label uses. No statistically significant difference was found in the distribution of prevalence of irregular prescription either by the three age ranges or by level of severity of disease at admission (according to PIM risk categories).
  
  
  CONCLUSIONS
  The high prevalence of prescription of drugs not appropriate for children confirms, in the Brazilian context, the inadequate and inadvertent use of drugs either not approved or off-label for PICU use. This demonstrates the need to encourage further studies on the quality, efficacy and safety of drugs for pediatric use.
authors.affiliation: Dep de Pediatria, Universidade Federal do Rio Grande do Sul. carvalho.conex@uol.com.br
authors.forename: Paulo R A
authors.initials: PR
authors.lastname: Carvalho
authors.forename: Clarissa G
authors.initials: CG
authors.lastname: Carvalho
authors.forename: Patrícia T
authors.initials: PT
authors.lastname: Alievi
authors.forename: Jaqueline
authors.initials: J
authors.lastname: Martinbiancho
authors.forename: Eliana A
authors.initials: EA
authors.lastname: Trotta
mesh_terms: D000293:Adolescent; D001938:Brazil; D002648:Child; D002675:Child, Preschool; D000075202:Contraindications; D003430:Cross-Sectional Studies; D004347:Drug Interactions; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007223:Infant; D015278:Intensive Care Units, Pediatric; D008297:Male; D008508:Medication Errors; D004364:Pharmaceutical Preparations
chemical_list: D004364:Pharmaceutical Preparations