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美国食品药品监督管理局(FDA)发布黑框警告后,全国针对患有精神疾病的儿童和青少年开具抗抑郁药的情况。

National antidepressant prescribing in children and adolescents with mental health disorders after an FDA boxed warning.

作者信息

Mittal Manish, Harrison Donald L, Miller Michael J, Brahm Nancy C

机构信息

Health Economics and Outcomes Research, Abbvie, Dept. GMH1, AP31-1 NE, 1 North Waukegan Road, North Chicago, IL 60064, USA.

University of Oklahoma Health Sciences Center, College of Pharmacy, Department of Pharmacy: Clinical and Administrative Sciences - Oklahoma City, OK, USA.

出版信息

Res Social Adm Pharm. 2014 Sep-Oct;10(5):781-90. doi: 10.1016/j.sapharm.2013.11.001. Epub 2013 Nov 20.

Abstract

BACKGROUND

In October 2004, the U.S. Food and Drug Administration (FDA) issued a boxed warning about an increased risk of suicidality (i.e., suicidal ideation, behavior, or attempts) related to all antidepressants in children and adolescents.

OBJECTIVE

To describe national antidepressant prescribing patterns in children and adolescents before, during, and after the introduction of the FDA boxed warning.

METHODS

Cross-sectional data from the 2002-2009 National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) were used to describe antidepressant prescribing patterns within a nationally-representative sample of 4035 physician visits for children and adolescents diagnosed with depression or other psychiatric disorder(s) [i.e., anxiety disorders or attention deficit/hyperactivity disorder (ADHD)].

RESULTS

In 2002-2003, antidepressants were prescribed in 4.1 million (36.1%) visits, followed by 3.2 million (28.8%) visits in 2004-2005 and 2.8 million (26.8%) visits in 2006-2007. However, antidepressant prescribing patterns reversed during 2008-2009, with an increase to 3.6 million (32.5%) visits. Compared to the period preceding the FDA boxed warning (2002-2003), a significant decline in visits related to antidepressant prescribing detected in the immediate post-FDA boxed warning period (2006-2007) (AOR = 0.67, 95% CI: 0.47-0.96). No association between the FDA boxed warning and antidepressant prescribing visits was detected during the FDA boxed warning period (2004-2005) (AOR = 0.80, 95% CI: 0.53-1.21) and in the late post-FDA boxed warning period (2008-2009) (AOR = 1.01, 95% CI: 0.63-1.60).

CONCLUSIONS

After a 2-year lag period, antidepressant prescribing for visits of children and adolescents diagnosed with depression or other psychiatric disorder(s) in community-based and outpatient clinic settings declined when compared to the period preceding the FDA boxed warning. This decline was not sustained in the period of five years after implementation of the FDA boxed warning.

摘要

背景

2004年10月,美国食品药品监督管理局(FDA)发布了一项黑框警告,指出儿童和青少年使用所有抗抑郁药物后自杀倾向(即自杀意念、行为或企图)风险增加。

目的

描述FDA发布黑框警告之前、期间和之后全国范围内儿童和青少年抗抑郁药物的处方模式。

方法

利用2002 - 2009年国家门诊医疗护理调查(NAMCS)和国家医院门诊医疗护理调查(NHAMCS)的横断面数据,描述在全国具有代表性的4035例被诊断为抑郁症或其他精神疾病(即焦虑症或注意力缺陷多动障碍(ADHD))的儿童和青少年患者就诊时的抗抑郁药物处方模式。

结果

在2002 - 2003年,410万(36.1%)次就诊中开具了抗抑郁药物,随后在2004 - 2005年为320万(28.8%)次就诊,2006 - 2007年为280万(26.8%)次就诊。然而,抗抑郁药物的处方模式在2008 - 2009年出现逆转,增至360万(32.5%)次就诊。与FDA发布黑框警告之前的时期(2002 - 2003年)相比,在FDA发布黑框警告后的紧接着时期(2006 - 2007年),与抗抑郁药物处方相关的就诊次数显著下降(比值比(AOR)= 0.67,95%置信区间(CI):0.47 - 0.96)。在FDA发布黑框警告期间(2004 - 2005年)(AOR = 0.80,95% CI:0.53 - 1.21)以及在FDA发布黑框警告后的后期(2008 - 2009年)(AOR = 1.01,95% CI:0.63 - 1.60),未检测到FDA黑框警告与抗抑郁药物处方就诊之间的关联。

结论

经过两年的滞后期,与FDA发布黑框警告之前的时期相比,在社区和门诊诊所环境中,被诊断为抑郁症或其他精神疾病的儿童和青少年就诊时的抗抑郁药物处方量有所下降。在FDA发布黑框警告实施后的五年期间,这种下降并未持续。

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