School of Pharmacy, Social Pharmacy, Faculty of Health Sciences, University of Eastern Finland, P.O. Box 1627, 70211 Kuopio, Finland.
Eur J Clin Pharmacol. 2013 Apr;69(4):985-94. doi: 10.1007/s00228-012-1426-z. Epub 2012 Oct 24.
Drug-related problems (DRPs) are common in paediatric pharmacotherapy, but few studies describe them from the parents' perspective. In the present survey, we have investigated the lifetime prevalence and type of DRPs in children in Finland.
This was a population-based survey of a random sample of 6,000 children below 12 years of age in 2007. A questionnaire was sent to their parents. The final response rate was 67% with a study population of 4,032. The main outcome measure was the lifetime prevalence and type of DRPs.
The lifetime prevalence of DRPs was 21% (95% CI 20-22). The most common (82%) of the 1,346 reported DRPs were adverse drug events (ADEs). The prevalence of ADEs was 17% (95% CI 16-19), that of other DRPs 5.2% (95% CI 4.5-5.9). The prevalence of serious ADEs was 0.4% and that of unexpected ADEs was 0.8%. The most common system involved in the ADEs was the gastrointestinal tract, comprising 34% of the 1,106 ADEs. The most common of the 240 other DRPs were problems with the administration and dosing of medicine (86%). Overall, 64% of DRPs were related to anti-infectives.
One fifth of the Finnish children below 12 years of age had experienced DRPs. Appropriate counselling, including possible adverse drug reactions and dosing directions, is important for parents and children at both the prescribing and dispensing of medicines for paediatric patients. Reporting of any suspected serious or unexpected ADEs is an essential part of efficient pharmacovigilance in paediatrics.
药物相关问题（DRPs）在儿科药物治疗中很常见，但很少有研究从家长的角度描述它们。在本研究中，我们调查了芬兰儿童一生中 DRPs 的发生率和类型。
这是一项基于人群的调查，对 2007 年 6000 名 12 岁以下儿童进行了随机抽样。向他们的父母发送了一份问卷。最终的回复率为 67%，研究人群为 4032 人。主要观察指标为一生中 DRPs 的发生率和类型。
DRPs 的终生发生率为 21%（95%CI 20-22）。报告的 1346 例 DRPs 中最常见的（82%）是药物不良反应（ADEs）。ADEs 的发生率为 17%（95%CI 16-19），其他 DRPs 的发生率为 5.2%（95%CI 4.5-5.9）。严重 ADEs 的发生率为 0.4%，意外 ADEs 的发生率为 0.8%。最常涉及的系统是胃肠道，占 1106 例 ADEs 的 34%。240 例其他 DRPs 中最常见的是药物管理和剂量问题（86%）。总体而言，64%的 DRPs 与抗感染药物有关。
12 岁以下的芬兰儿童中有五分之一经历过 DRPs。在为儿科患者开具和配药时，为家长和儿童提供适当的咨询，包括可能的药物不良反应和剂量指导，非常重要。报告任何疑似严重或意外的 ADEs 是儿科药物警戒的重要组成部分。
