Luigi Sacco Hospital, Department of Pediatrics, Università degli Studi di Milano, Via GB Grassi, 74, 20157, Milan, Italy.
Expert Opin Drug Saf. 2012 Jan;11(1):95-105. doi: 10.1517/14740338.2011.584531. Epub 2011 May 9.
The detection, assessment, understanding and prevention of adverse drug reactions (ADRs) are the primary aims of pharmacovigilance activities. Pediatric patients, especially all newborns and infants, are particularly at risk for experiencing drug-related adverse events.
This review briefly analyzes the physiological peculiarities of pharmacodynamic and pharmacokinetic aspects of drugs in newborns, infants and toddlers and children. It also deals with specific pediatric pharmacovigilance aspects, such as the frequent use of unlicensed and/or off-label drugs in neonatal intensive care units in European countries and in Australia. This review reports on European, American and Canadian data about the incidence and type of pediatric ADRs, particularly focusing on neonates, infants and toddlers.
The awareness of pediatricians about the importance of reporting ADRs should be stimulated, new reporting systems should be encouraged and pediatric pharmacovigilance activities should be improved, first, by intensifying active post-marketing surveillance methods.
药物警戒活动的主要目的是检测、评估、理解和预防药物不良反应（ADR）。儿科患者，尤其是所有新生儿和婴儿，特别容易发生与药物相关的不良事件。
本综述简要分析了新生儿、婴儿和幼儿以及儿童的药物药效学和药代动力学方面的生理特点。它还涉及特定的儿科药物警戒方面，例如在欧洲国家和澳大利亚的新生儿重症监护病房中经常使用未经许可和/或标签外的药物。本综述报告了欧洲、美国和加拿大关于儿科 ADR 发生率和类型的数据，特别是重点关注新生儿、婴儿和幼儿。
应鼓励儿科医生提高对报告 ADR 重要性的认识，鼓励使用新的报告系统，并应通过加强上市后主动监测方法首先改进儿科药物警戒活动。
