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评估卫生系统对药物安全警告的响应能力。

Assessing Responsiveness of Health Systems to Drug Safety Warnings.

机构信息

Department of Psychiatry, University of Michigan Medical School, Ann Arbor, MI.

Department of Psychiatry, University of Michigan Medical School, Ann Arbor, MI; Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI.

出版信息

Am J Geriatr Psychiatry. 2018 Apr;26(4):476-483. doi: 10.1016/j.jagp.2017.09.024. Epub 2017 Sep 28.

DOI:10.1016/j.jagp.2017.09.024
PMID:29066038
Abstract

OBJECTIVE

In 2011-2012 the U.S. Food and Drug Administration (FDA) issued safety announcements cautioning providers against prescribing high doses of citalopram given concerns for QT prolongation. The authors evaluated Veterans Affairs (VA) national trends in citalopram use and dose compared with alternative antidepressants after the FDA warnings.

METHODS

Time series analyses estimated the effect of the FDA warnings on citalopram and other antidepressant across three periods: before the first FDA warning in August 2011, after the 2011 FDA warning until the second warning in March 2012, and after the 2012 FDA warning. In a National VA health system, adult VA outpatients prescribed citalopram or alternative antidepressants from February 2010 to September 2013 were studied. Outpatient use of high-dose citalopram (>40 or >20 mg daily in adults aged > 60 years) including the proportion of patients prescribed citalopram and difference between study periods.

RESULTS

Between the first and second FDA warnings, among patients aged 18-60, high-dose citalopram use decreased by 2.0% per month (p < 0.001) and by 1.9% per month (p < 0.001) for older adults. After the second FDA warning in 2012, 30.7% of older patients remained on doses higher than the newly recommended dose of 20 mg. Reductions in overall use of citalopram were accompanied by significant increases in prescriptions of alternative antidepressants, with sertraline most widely prescribed.

CONCLUSION

Although trends in high-dose citalopram use declined after the 2011-2012 FDA warnings, roughly one-third of older adults still remained on higher than recommended doses. Concomitant increases in sertraline and other antidepressant prescriptions suggest potential substitution of these medications for citalopram.

摘要

目的

2011-2012 年,美国食品和药物管理局(FDA)发布安全公告,警告医务人员避免开出高剂量西酞普兰,因为担心会导致 QT 间期延长。作者评估了 FDA 警告发布后,退伍军人事务部(VA)国家西酞普兰使用和剂量与其他抗抑郁药的趋势。

方法

时间序列分析估计了 FDA 警告对三种时期内西酞普兰和其他抗抑郁药的影响:2011 年 8 月第一次 FDA 警告之前、2011 年 FDA 警告之后至 2012 年 3 月第二次警告之前,以及 2012 年第二次 FDA 警告之后。在一个国家退伍军人健康系统中,研究了 2010 年 2 月至 2013 年 9 月期间,开处西酞普兰或其他抗抑郁药的成年退伍军人门诊患者。研究了高剂量西酞普兰(18-60 岁年龄组中,成年人每日>40 或>20mg)的使用情况,包括开处西酞普兰的患者比例以及研究期间的差异。

结果

在第一次和第二次 FDA 警告之间,在 18-60 岁年龄组的患者中,高剂量西酞普兰的使用率每月下降 2.0%(p<0.001),在老年人中每月下降 1.9%(p<0.001)。在 2012 年第二次 FDA 警告后,仍有 30.7%的老年患者服用的剂量高于新推荐的 20mg 剂量。西酞普兰总体使用量的减少伴随着替代抗抑郁药处方的显著增加,其中舍曲林最广泛使用。

结论

尽管 2011-2012 年 FDA 警告发布后,高剂量西酞普兰的使用趋势有所下降,但仍有大约三分之一的老年人仍服用高于推荐剂量的药物。舍曲林和其他抗抑郁药处方的同时增加表明,这些药物可能替代了西酞普兰。

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