397 ORIGINAL ARTICLE Prescription of drugs not appropriate for children in a Pediatric Intensive Care Unit Paulo R. Antonacci Carvalho, 1 Clarissa G. Carvalho, 2 Patrícia T. Alievi, 3 Jaqueline Martinbiancho, 4 Eliana A. Trotta 5 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). Conclusion: 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. J Pediatr (Rio J) 2003;79(5):397-402: Children, drugs, intensive care, not approved prescribing, off label prescribing. 0021-7557/03/79-05/397 Jornal de Pediatria Copyright © 2003 by Sociedade Brasileira de Pediatria 1. Associate professor, Department of Pediatrics, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS) 2. Graduate student, School of Medicine, Universidade Federal do Rio Grande do Sul. 3. Resident physician, PICU, Hospital de Clínicas de Porto Alegre. 4. Pharmacist, Pharmacy Service, Hospital de Clínicas de Porto Alegre. 5. Associate professor, Department of Pediatrics, Universidade Federal do Rio Grande do Sul. Head physican, PICU, Hospital de Clínicas de Porto Alegre. Manuscript received Feb 27 2003, accepted for publication Jun 17 2003.