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CONTEXT AND OBJECTIVES: Adverse drug reactions (ADRs) may cause prolonged hospital admissions with high treatment costs. The burden of ADRs in children has never been evaluated in Nigeria. The incidence of pediatric ADRs and the estimated cost of treatment over an 18-month period were determined in this study. DESIGN AND SETTING:Prospective observational study on children admitted to the pediatric wards of the Lagos State University Teaching Hospital (LASUTH) in Nigeria, between July 2006 and December 2007. METHODS:Each patient was assessed for ADRs throughout admission. Medical and non-medical costs to the hospital and patient were estimated for each ADR by reviewing the medical and pharmacy bills, medical charts and diagnostic request forms and by interviewing the parents. Cost estimates were performed in 2007 naira (Nigeria currency) from the perspectives of the hospital (government), service users (patients) and society (bearers of the total costs attributable to treating ADRs). The total estimated cost was expressed in 2007 United States dollars (USD). RESULTS:Two thousand and four children were admitted during the study; 12 (0.6%) were admitted because of ADRs and 23 (1.2%) developed ADR(s) during admission. Forty ADRs were suspected in these 35 patients and involved 53 medicines. Antibiotics (50%) were the most suspected medicines. Approximately 1.83 million naira (USD 15,466.60) was expended to manage all the patients admitted due to ADRs. CONCLUSIONS:Treating pediatric ADRs was very expensive. Pediatric drug use policies in Nigeria need to be reviewed so as to discourage selfmedication, polypharmacy prescription and sales of prescription medicines without prescription. CONCLUSÕES: O tratamento das RAD pediátricas foi bastante caro. As políticas de uso de drogas em pediatria na Nigéria devem ser revistas para desencorajar a auto-medicação, a prescrição de polifarmácia e a venda de medicamentos de prescrição sem prescrição.

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