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

University Of Houston, Houston TX

Investigators

Abstract

[unreadable] 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. [unreadable] [unreadable] [unreadable] [unreadable]