The Impact of the FDA Antidepressant Black Box Warning on Psychiatric Practice

描述(申请人提供)：这项拟议的研究将审查食品和药物管理局(FDA)抗抑郁药黑匣子警告对儿童和青少年精神药物和精神服务使用的政策影响。FDA发布了第一个公共卫生建议，警告服用抗抑郁药物的儿童和青少年有自杀风险，这成为从业者调整自己的做法的一个重要挑战。虽然人们普遍认为，这一警告对精神病学实践产生了深远的影响，但由于缺乏关于其他精神药物和精神科服务用途转移的可靠信息，因此很难确定在发出警告后，儿童和青少年的精神护理是改善了还是恶化了。这项申请建议通过比较FDA第一次抗抑郁药公共卫生咨询(2004年3月)之前和之后6至18岁的医疗补助人群的精神病学实践质量来试点解决这一问题。主要成果衡量标准反映了研究的三个具体目标。目的1：定量评估抗抑郁药和抗精神病药物的使用变化。目的2：了解心理治疗使用情况的变化。目的3：根据FDA推荐的抗抑郁药物监测模式在黑匣子警告前后的变化情况。将实施非等价因变量前测后测/中断时间序列设计，以评估与抗抑郁药黑盒警告相关的感兴趣结果的变化。之所以选择此设计，是因为不存在不受抗抑郁药黑盒警告影响的对照组。该提案的发现可以通过提供关于发出警告前后抗抑郁药物处方量的变化、潜在的抗精神病药物或心理治疗替代以及遵守FDA抗抑郁药监测建议的有价值的信息，大大促进对黑盒警告对医生执业影响的了解。研究结果也将为政策制定者在考虑对抗抑郁药以外的精神药物发出新的黑匣子警告时提供很好的参考。

DESCRIPTION (provided by applicant): This proposed study will examine the policy impact of the Food and Drug Administration (FDA) antidepressant black box warning on the utilizations of psychotropic medications and psychiatric services among children and adolescents. It becomes an important challenge for practitioners to adapt their practice after the FDA issued its first public health advisory warning the risk of suicidality among children and adolescents taking antidepressant medications. Although it is generally believed that the warning has made a profound impact on psychiatric practice, the lack of reliable information on the shift of utilizations on other psychotropic medications and psychiatric service makes it difficult to determine whether the psychiatric care in children and adolescents has been improved or deteriorated after the warning has been issued. This application proposes to pilot address this issue by comparing the quality of psychiatric practice before and after the first FDA antidepressant public health advisory (March, 2004) among Medicaid population between 6 and 18 years of age. Major outcome measures reflect three study specific aims. Aim 1: To quantitatively assess the change in the use of antidepressant and antipsychotic drugs. Aim 2: To examine the change in the utilization of psychotherapy. Aim 3: To examine the change in antidepressant monitoring pattern based on the FDA recommendations before and after the black box warning. A nonequivalent dependent variable pretest posttest/interrupted time series design will be implemented to assess the changes in outcomes of interest that are associated with antidepressant black box warning. This design is selected because a control group that is not affected by the antidepressant black box warning does not exist. Findings from the proposal could substantially advance the knowledge regarding the impact of black box warning on physicians' practice by providing valuable information on the change in prescribing volume of antidepressant medications before and after the warning was issued, potential antipsychotic or psychotherapy substitution, and the adherence to the FDA antidepressant monitoring recommendation. The study findings will also be a good reference for the policy makers when new black box warning is considered for psychiatric drugs other than antidepressants.