Shin Ju-Young, Lee Shin Haeng, Shin Sun Mi, Shin Han Na, Park Byung-Joo
Korea Institute of Drug Safety and Risk Management (KIDS), Seoul, Republic of Korea.
Korea Institute of Drug Safety and Risk Management (KIDS), Seoul, Republic of Korea; Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Regul Toxicol Pharmacol. 2015 Jul;72(2):244-8. doi: 10.1016/j.yrtph.2015.04.022. Epub 2015 May 6.
In December 2009, Korean regulatory agency announced that methylphenidate, a drug used to treat attention deficit-hyperactivity disorder (ADHD), should not be used in children aged five and under due to the risk of sudden cardiac death. This study examined the impact of regulatory action and prescribing patterns. We conducted a time series analysis using the Korea National Health Insurance Service database. Study subjects included children under 18years old with ADHD from January 2007 to December 2011. Contraindicated use of methylphenidate was defined as use of methylphenidate at least once in children aged five and under. We selected additional control points (2007, 2008, and 2010) and compared the methylphenidate use one year before and after each point. We calculated relative and absolute reductions, and 95% confidence intervals. The total number of ADHD patients was 376,298. Overall, there was a 70.87% relative reduction (95% CI: 63.33%-79.31%) and a 0.93% absolute reduction (95% CI: 0.51%-0.60%) of methylphenidate use. The relative and absolute reductions were 27.61% (95% CI: 24.76%-30.78%) and 0.31% (95% CI: 0.21%-0.41%) in 2007; 43.58% (95% CI: 38.02%-49.96%) and 0.35% (95% CI: 0.27%-0.43%) in 2008; 46.52% (95% CI: 38.86%-55.70%) and 0.21 (95% CI: 0.15%-0.27%) in 2009; and 10.20% (95% CI: 8.32%-12.50%) and 0.02% (95% CI: 0.02%-0.07%) in 2010. Korean regulatory action led to a moderate decrease in contraindicated methylphenidate use even after the steep decline before the regulatory action.
2009年12月，韩国监管机构宣布，用于治疗注意力缺陷多动障碍（ADHD）的药物哌甲酯，因存在心源性猝死风险，不应在5岁及以下儿童中使用。本研究考察了监管行动及处方模式的影响。我们利用韩国国民健康保险服务数据库进行了一项时间序列分析。研究对象包括2007年1月至2011年12月期间患有ADHD的18岁以下儿童。哌甲酯的禁忌使用定义为在5岁及以下儿童中至少使用过一次哌甲酯。我们选取了额外的控制点（2007年、2008年和2010年），并比较了各点前后一年的哌甲酯使用情况。我们计算了相对和绝对减少量以及95%置信区间。ADHD患者总数为376,298人。总体而言，哌甲酯的使用相对减少了70.87%（95%置信区间：63.33%-79.31%），绝对减少了0.93%（95%置信区间：0.51%-0.60%）。2007年相对和绝对减少量分别为27.61%（95%置信区间：24.76%-30.78%）和0.31%（95%置信区间：0.21%-0.41%）；2008年分别为43.58%（95%置信区间：38.02%-49.96%）和0.35%（95%置信区间：0.27%-0.43%）；2009年分别为46.52%（95%置信区间：38.86%-55.70%）和0.21（95%置信区间：0.15%-0.27%）；2010年分别为10.20%（95%置信区间：8.32%-12.50%）和0.02%（95%置信区间：0.02%-0.07%）。韩国的监管行动导致禁忌使用哌甲酯的情况出现适度下降，即便在监管行动前已有大幅下降之后亦是如此。
