Woo Yeonju, Kim Hyung Eun, Chung Sooyoun, Park Byung Joo
Korea Institute of Drug Safety & Risk Management, Seoul, Korea.
Korea Institute of Drug Safety & Risk Management, Seoul, Korea. ; Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
J Korean Med Sci. 2015 Apr;30(4):371-7. doi: 10.3346/jkms.2015.30.4.371. Epub 2015 Mar 19.
Children have dynamic process of maturation and substantial changes in growth and development which eventually make the drug safety profiles different from adults. Medication errors (MEs) in pediatrics are reported to occur three times more likely than adults. The aims of this study were to identify the characteristics of pediatric MEs in Korea at national level and help raise awareness of risks from the MEs in pediatrics. We conducted a descriptive analysis with the pediatric ME reports in Korea Adverse Event Reporting System (KAERS) database from 1989 to 2012 and 208 ME reports in pediatrics were found. Based on KAERS database, the proportion of reported pediatric ME in adverse drug event (ADE) reports was 2.73 times (95% CI, 2.35-3.17) higher than that of adult ME. In 208 ME reports, we found a total of 236 ME-related terms within 19 types of MEs. The most common type of MEs was "accidental overdose" (n=58, 24.6%), followed by "drug maladministration" (n=50, 21.2%) and "medication error" (n=41, 17.4%). After the narratives of ME reports were reviewed, we noticed that most of them did no harm to patients, but some cases were needed for medical treatment. Our data suggest that MEs in pediatrics are not negligible in Korea. We expect that this study would increase the awareness of the problem in pediatric MEs and induce the need for further development of an effective national ME preventing system in Korea.
儿童有着动态的成熟过程以及生长发育中的显著变化，这最终使得药物安全情况与成人不同。据报道，儿科用药错误（MEs）的发生几率是成人的三倍。本研究的目的是在国家层面识别韩国儿科用药错误的特征，并帮助提高对儿科用药错误风险的认识。我们对韩国不良事件报告系统（KAERS）数据库中1989年至2012年的儿科用药错误报告进行了描述性分析，共发现208份儿科用药错误报告。基于KAERS数据库，儿科用药错误在药物不良事件（ADE）报告中的比例比成人用药错误高2.73倍（95%可信区间，2.35 - 3.17）。在208份用药错误报告中，我们在19种用药错误类型中总共发现了236个与用药错误相关的术语。最常见的用药错误类型是“意外过量”（n = 58，24.6%），其次是“给药不当”（n = 50，21.2%）和“用药差错”（n = 41，17.4%）。在审查了用药错误报告的叙述内容后，我们注意到大多数报告对患者没有造成伤害，但有些病例需要进行治疗。我们的数据表明，在韩国，儿科用药错误不可忽视。我们期望这项研究能提高对儿科用药错误问题的认识，并引发韩国进一步开发有效的国家用药错误预防系统的需求。
