Prevalence of Therapeutic Drug Monitoring for Lithium and the Impact of Regulatory Warnings: Analysis Using Japanese Claims Database.
Prevalence of Therapeutic Drug Monitoring for Lithium and the Impact of Regulatory Warnings: Analysis Using Japanese Claims Database.
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DOI：
10.1097/ftd.0000000000000483
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发表时间：
2018-04
影响因子：
2.5
通讯作者：
Fukuoka N
中科院分区：
文献类型：
--
作者：
Ooba N;Tsutsumi D;Kobayashi N;Hidaka S;Hayashi H;Obara T;Satoh M;Kubota K;Fukuoka N
指南中建议对锂进行治疗药物监测（TDM）；然而，锂的TDM患病率很少报道。因此，我们调查了锂的TDM患病率，并评估了要求常规TDM治疗锂的监管警告的影响。对2005年1月1日至2015年3月31日期间覆盖约170万20-74岁人群的每月索赔数据进行了评估。所有至少有一个锂处方的患者被选择并包括计算锂引起的TDM的年患病率。此外，我们还使用分段回归分析评估了2012年4月和2012年9月发布的2个要求锂常规TDM的监管警告是否对锂的TDM有影响。2005 - 2014年，5823例患者共开了136956张锂药处方，锂药所致TDM年患病率为14.9%（95%可信区间为14.7%-15.1%）。分析发现，2012年4月监管预警后，平均患病率突然上升6.9% (P = 0.001)，而2012年9月监管预警后，平均患病率下降1.2% （P = 0.47）。2012年4月预警后（2012年4月- 2012年8月）期患病率与预警前（2010年4月- 2012年3月）期患病率趋势无显著变化。同样，在2012年9月预警之前（2012年4月- 2012年8月）和之后（2012年9月- 2014年3月）的趋势也没有明显变化。结果显示，尽管指南强烈推荐锂的TDM，但锂的TDM患病率很低。在5个月的时间里，监管机构发出了两次警告，要求在使用锂治疗期间遵守血液水平的测量，这与锂引起的TDM患病率的增加有关。然而，与第一次警告相比，第二次警告的影响并不显著。
Therapeutic drug monitoring (TDM) for lithium is recommended in guidelines; however, the prevalence of TDM for lithium is seldom reported. We have therefore investigated the prevalence of TDM for lithium and evaluated the impact of the regulatory warnings requiring routine TDM for lithium. Monthly claims data covering around 1.7 million persons aged 20–74 years old during the period January 1, 2005, and March 31, 2015, were evaluated. All patients who had at least one prescription for lithium were selected and included to calculate the annual prevalence of TDM for lithium. Also we assessed whether the 2 regulatory warnings requiring routine TDM for lithium and issued in April 2012 and September 2012 had an impact on TDM for lithium, using segmented regression analysis. Between 2005 and 2014, 136,956 prescriptions of lithium were issued to 5823 patients, and the annual prevalence of TDM for lithium was 14.9% (95% confidence interval, 14.7%–15.1%). The analysis revealed that the mean prevalence increased abruptly by 6.9% (P = 0.001) after the regulatory warning in April 2012, whereas that the warning in September 2012 decreased by 1.2% (P = 0.47). There was no significant change in trends of period prevalence after the warning in April 2012 (April 2012–August 2012) compared with prevalence before the warning (April 2010–March 2012). Similarly, no significant change was observed in the trends before (April 2012–August 2012) and after (September 2012–March 2014) the subsequent warning in September 2012. Results showed that the prevalence of TDM for lithium was low, although TDM for lithium was strongly recommended by the guidelines. Regulatory warnings requiring compliance with the measurement of blood levels during treatment with lithium, issued twice during the five-month period, were associated with an increase in the prevalence of TDM for lithium. However, the impact of the second warning was not remarkable compared with the first warning.