Effect of FDA Boxed Warnings and Public Information on Pharmaceutical Use

描述（由申请人提供）：由于众所周知的药物停药或不良反应，公众对美国药品供应的安全性越来越关注。医学研究所最近对食品和药物管理局（FDA）可用的监督选项进行了一项研究，得出结论认为，在确定和处理上市后药物安全问题的方式上需要进行实质性的改进。FDA使用的最严格的标签工具是强制使用黑框警告。然而，黑框警告是在复杂的信息环境中发布的，包括直接面向消费者的广告（DTCA）、一般新闻媒体报道、科学期刊出版物和直接面向医生的营销。目前还没有研究确定替代的安全信息来源如何同时促进处方行为的改变，以及黑框警告机制是否对药物使用有任何边际影响。这一点尤其重要，因为FDA准备投入大量的资源和时间来修改其安全系统，如果盒装警告工具对处方行为的影响很小或没有边际效应，这将是低效的。因此，该项目将有三个目标：(1)检查公共信息的影响——包括媒体报道、DTCA、医生指导营销和临床研究——以及黑盒警告对患者进入医生诊所的影响；(2)检查公共信息对合理开药可能性的影响；(3)检查FDA发布的黑框警告对特定药物适当处方的可能性的影响。该提案是由医疗保健研究和质量局资助的一项已完成的研究补助金的竞争性延续，题为“直接面向消费者的药品营销的影响”（1R01HS011326-01A2）。具体目标将通过评估实证模型来实现，该模型检验了处方如何受到公共信息和FDA发布的咨询和黑框警告的影响。我们将使用一个独特的电子病历数据库，该数据库包含119个地理位置分散的医生的800多万名患者。我们将在以下三种疾病/药物类别的背景下进行研究：1)用于哮喘管理的长效激动剂，2)用于青少年的抗抑郁药，以及3)用于疼痛管理的选择性和非选择性非甾体抗炎药。

DESCRIPTION (provided by applicant): Public concern has grown about the safety of the U.S. pharmaceutical supply due to well-publicized drug withdrawals or adverse reactions. The Institute of Medicine recently conducted a study of the oversight options available to the Food and Drug Administration (FDA) and concluded that substantial improvements are required in the way that post-marketing drug safety issues are identified and handled. The most restrictive labeling tool used by the FDA is mandating a boxed warning. However, boxed warnings are issued in the midst of a complex information environment that includes direct to consumer advertising (DTCA), general news media coverage, scientific journal publications, and direct to physician marketing. No research has been conducted to determine how the alternative sources of information on safety work simultaneously to prompt changes in prescribing behavior and whether the boxed warning mechanism has any marginal effect on pharmaceutical use. This is particularly important since the FDA is poised to devote substantial resources and time into revising its safety system, which would be inefficient if the boxed warning tool has little or no marginal effect on prescribing behaviors. This project will therefore have three aims: (1) examine the effects of public information - including media reports, DTCA, physician-directed marketing, and clinical research - and black box warnings on the flow of patients into physician practices; (2) examine the effects of public information on the likelihood of appropriate drug prescribing; and (3) examine the impact of FDA issued boxed warnings on the likelihood of appropriate prescribing for specific medications. This proposal represents a competing continuation of a completed research grant funded by the Agency for Healthcare Research and Quality titled "Impact of Direct to Consumer Pharmaceutical Marketing" (1R01HS011326-01A2). The specific aims will be achieved by estimating empirical models that examine the how prescribing is affected by public information and the issuance of advisories and boxed warnings by the FDA. We will use a unique electronic medical record data base of over 8 million patients in 119 geographically dispersed physician practices. We will do so in the context of the following three disease / drug classes: 1) long-acting ¿2-agonists for asthma management, 2) antidepressant use in adolescents, and 3) use of selective and nonselective NSAIDs for pain management.