Adverse drug reactions and off‐label prescribing for paediatric outpatients: a one‐year survey of spontaneous reports in Sweden
作者： Mike Ufer , Elin Kimland , Ulf Bergman
DOI: 10.1002/PDS.858
关键词: Adverse drug reaction 、 Mucocutaneous zone 、 Medicine 、 Retrospective cohort study 、 Drug Utilization Review 、 Pediatrics 、 Off-label use 、 Drug Prescribing 、 Drug 、 Adverse effect
摘要: Purpose To investigate the extent and characteristics of off-label prescribing for paediatric outpatients among drugs reported to have caused an adverse reaction. Methods A retrospective, cross-sectional, observational analysis spontaneous drug reaction (ADR) reports in Sweden year 2000. We included all concerning prescribed younger than 16 years. Each ADR was classified with respect its causality, seriousness type reaction. Off-label evaluated age, dose, indication, formulation route frequency administration. Results We identified 112 patient-linked corresponding 158 ADRs which 31% were serious. Antiasthmatic most frequently suspected as a cause almost every third The average proportion amounted 42.4%. It more associated serious non-serious mostly due non-approved age or dose. common clinical manifestations psychiatric disorders mucocutaneous inflammatory reactions. Conclusions Off-label is ADR. suggested further identify unlabelled contributing to, particular children proper benefit-risk assessment use. Copyright © 2003 John Wiley & Sons, Ltd.
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