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Conroy, S., Choonara, I., Impicciatore, P., Mohn, A., Arnell, H., Rane, A., Knoeppel, C., Seyberth, H., Pandolfini, C., Raffaelli, M.P., Rocchi, F., Bonati, M., Jong, G., de Hoog, M. and van den Anker, J. (2000) Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for drug investigation in children. British Medical Journal, 320, 79-82. doi:10.1136/bmj.320.7227.79

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• TITLE: Active surveillance of adverse drug reactions in children in five Italian paediatric wards

  AUTHORS: Mariapina Gallo, Antonio Clavenna, Maurizio Bonati, Paolo Siani, Antonio Irpino, Francesco Rossi, Annalisa Capuano

  KEYWORDS: Child; Prospective Studies; Drug Therapy/Adverse Effects; Adverse Drug ReactionReporting System; Hospital

  JOURNAL NAME: Open Journal of Pediatrics, Vol.2 No.2, June 19, 2012

  ABSTRACT: Adverse drug reactions (ADRs) are an important clinical problem and contribute significantly to mortality and morbidity. Scant data on the safety of drug use in children are usually available at the time of marketing authorization, due to the limited number of trials performed in the paediatric population. Few studies monitored the incidence of ADRs in Italian hospitalized children, that cannot be compared for methodological reasons. A 6-month prospective observational study was, therefore, conducted on the paediatric wards of five hospitals in the Campania Region, Italy. Data were collected on all patients admitted to the wards during the study period through a structured questionnaire administered to the mothers and through a hospital chart review. Of the 752 patients enrolled, 86.2% were exposed to one or more drugs during hospitalization. The therapeutic class most prescribed was systemic antibacterial agents (47%). Six ADRs occurred during hospitalization (incidence 0.9%; 95% CI 0.2% - 1.7%). In addition, one child was admitted to a hospital for an ADR. Five out of seven ADRs occurred in girls. The skin was the most affected organ. The medications implicated were amoxicillin, acyclovir, ibuprofen, ceftriaxone, paracetamol, and ranitidine. According to the Naranjo probability criteria, six ADRs were probably, and one possibly, related to the suspected drug. In conclusion, this study reveals that ADRs may be under-reported in children hospitalized in the Campania Region. Consequently, healthcare personnel should be alert to the possibility of ADRs. More accurate reporting of ADRs in children would result in safer use of drugs in such patients.