Background: Adverse drug reactions in children are an important public health problem. We have undertaken a systematic\r\nreview of observational studies in children in three settings: causing admission to hospital, occurring during hospital stay\r\nand occurring in the community. We were particularly interested in understanding how ADRs might be better detected,\r\nassessed and avoided.\r\nMethods and Findings: We searched nineteen electronic databases using a comprehensive search strategy. In total, 102\r\nstudies were included. The primary outcome was any clinical event described as an adverse drug reaction to one or more\r\ndrugs. Additional information relating to the ADR was collected: associated drug classification; clinical presentation;\r\nassociated risk factors; methods used for assessing causality, severity, and avoidability. Seventy one percent (72/102) of\r\nstudies assessed causality, and thirty four percent (34/102) performed a severity assessment. Only nineteen studies (19%)\r\nassessed avoidability. Incidence rates for ADRs causing hospital admission ranged from 0.4% to 10.3% of all children (pooled\r\nestimate of 2.9% (2.6%, 3.1%)) and from 0.6% to 16.8% of all children exposed to a drug during hospital stay. Anti-infectives\r\nand anti-epileptics were the most frequently reported therapeutic class associated with ADRs in children admitted to\r\nhospital (17 studies; 12 studies respectively) and children in hospital (24 studies; 14 studies respectively), while antiinfectives\r\nand non-steroidal anti-inflammatory drugs (NSAIDs) were frequently reported as associated with ADRs in\r\noutpatient children (13 studies; 6 studies respectively). Fourteen studies reported rates ranging from 7%ââ?¬â??98% of ADRs being\r\neither definitely/possibly avoidable.\r\nConclusions: There is extensive literature which investigates ADRs in children. Although these studies provide estimates of\r\nincidence in different settings and some indication of the therapeutic classes most frequently associated with ADRs, further\r\nwork is needed to address how such ADRs may be prevented.
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