WorldWide Epidemiology, Quantitative Sciences, GlaxoSmithKline, LLC, Collegeville, PA, USA,
Paediatr Drugs. 2014 Aug;16(4):331-6. doi: 10.1007/s40272-014-0077-1.
Retapamulin, a topical pleuromutilin that selectively inhibits bacterial protein synthesis, is approved for treatment of impetigo and secondarily infected traumatic lesions in adults and in children older than 9 months of age.
A 5-year study was conducted to monitor prescription use in children younger than 9 months of age.
Annual prescription events were monitored in the UK Clinical Practice Research Datalink (CPRD) and the Clinformatics™ DataMart Multiplan (IMPACT), a product of OptumInsight Life Sciences, Inc. (Eden Prairie, MN, USA), from the USA.
In the CPRD, of 148 prescriptions, three (2 %) were identified in children aged less than 9 months between years 2008 and 2011. In IMPACT, of 59,210 claims for retapamulin in children, 1,951 (3.3 %) were categorized as definitive, or uncertain for, less than 9 months of age between 2007 and 2011.
Retapamulin prescription events in children aged less than 9 months were relatively low compared with other recent estimations of off-label pediatric medicines. Our report provides a framework for future investigations and discussions that may facilitate off-label reporting schemes and promote pediatric drug safety.
雷帕霉素是一种局部应用的截短侧耳素，可选择性抑制细菌蛋白质合成，适用于治疗脓疱疮和 9 个月以上儿童的继发性感染创伤病变。
开展了一项为期 5 年的研究，以监测 9 个月以下儿童的处方使用情况。
从英国临床实践研究数据链（CPRD）和 OptumInsight Life Sciences, Inc.（美国明尼苏达州伊登草原）的 Clinformatics™ DataMart Multiplan（IMPACT）监测了每年的处方事件。
在 CPRD 中，2008 年至 2011 年间，148 份处方中有 3 份（2%）在 9 个月以下儿童中确定。在 IMPACT 中，在 2007 年至 2011 年间，59210 份雷帕霉素儿童用药中，有 1951 份（3.3%）被归类为明确或不确定的 9 个月以下儿童用药。
与其他最近对非标签儿科药物的估计相比，9 个月以下儿童使用雷帕霉素的处方事件相对较少。我们的报告为未来的调查和讨论提供了一个框架，这可能有助于非标签报告计划，并促进儿科药物安全。
