Assessing the effect of FDA advisories on provider, patient, and firm behavior

描述（由申请人提供）：美国食品药品监督管理局（FDA）负责向供应商和公众传达处方药风险，哨兵计划将大幅增加FDA必须评估的安全信号数量。FDA用于传达这些风险的两个最重要的策略是MedWatch安全警报和公共卫生咨询，但有关其影响的信息有限。迄今为止，大多数研究都检查了选择警告对药物总处方率的影响，如对乙酰氨基酚，氟哌利多，西沙必利，以及最近的选择性5-羟色胺再摄取抑制剂。然而，这些研究中有许多是基于调查的，即使是那些使用管理数据来检查药物使用的研究，也包括对提供者、患者和公司反应的有限评估。这一点很重要，因为评估FDA警告的最终影响是一项复杂的任务，因为它可能：（1）具有基于临床环境和提供者特征而变化的影响，（2）改变非目标患者群体中的需求，（3）导致治疗替代品使用的增加，（4）导致门诊和其他非处方使用的变化，以及（5）导致制药公司战略行为的改变，如营销和促销，这可能对医生处方和患者用药产生强烈的独立影响。之前对FDA警告的研究留下了许多其他重要问题没有回答，包括它们对依从性和治疗替代的影响，医生对此类通信的反应存在显著差异的程度，以及公司在发生警报或咨询时可能采取的战略步骤。我们建议使用纵向医疗补助和MarketScan私人健康计划索赔以及基于办公室的处方审计，以检查FDA警告对抗精神病药，抗抑郁药和注意力缺陷/多动障碍（ADHD）治疗的影响。除了研究非老年人在处方和其他医疗保健使用方面的变化外，我们还将探讨儿童和老年人的这种变化，这两个亚群特别相关和令人关注。最后，我们将研究企业如何修改他们的营销和促销策略，以供应商和消费者在回应这些通信。我们的分析将使用先进的计量经济学技术严格进行，将为致力于确保有效传播有关这些和其他广泛使用的处方药类别的安全信息的政策制定者和其他利益相关者提供重要信息。 公共卫生相关性：FDA实施安全警报和公共卫生公告，以解决处方药的紧急安全问题。然而，人们对这些警告如何影响提供者、患者和公司的行为以及这些策略在最大限度地降低风险方面的有效性知之甚少。我们将使用计量经济学方法分析各种互补的国家数据库，以评估这些策略的有效性，并确定可以改善风险沟通的因素，这将有助于保障公共健康，同时最大限度地提高临床创新。

DESCRIPTION (provided by applicant): The Food and Drug Administration (FDA) is responsible for communicating prescription drug risks to providers and the public, and the Sentinel Initiative will substantially increase the number of safety signals that the FDA must evaluate. Two of the most important strategies that the FDA uses to communicate these risks are MedWatch Safety Alerts and Public Health Advisories, yet there is limited information regarding their effect. Most research to date has examined the impact of select warnings on the aggregate prescribing rates of drugs such as acetaminophen, droperidol, cisapride, and more recently, selective serotonin reuptake inhibitors. However, many of these studies have been survey based, and even those using administrative data to examine medication use have included a limited assessment of provider, patient, and firm response. This is important because assessing the ultimate impact of an FDA warning is a complex task, since it may: (1) have an impact that varies based on clinical setting and provider characteristics, (2) alter demand among non- targeted patient populations, (3) cause increases in the use of therapeutic substitutes, (4) lead to changes in the use of office-visits and other non-prescription utilization, and (5) lead to alterations in the strategic behavior of pharmaceutical firms, such as in marketing and promotion, which may exert strong independent effects on physician prescribing and patient medication use. Prior work examining FDA warnings leaves numerous other important questions unanswered, including their impact on adherence and therapeutic substitution, the degree to which there is significant physician variability in the response to such communications, and the strategic steps that firms may take when an alert or advisory occurs. We propose to use longitudinal Medicaid and MarketScan private health plan claims as well as audits of office-based prescribing to examine the impact of FDA warnings on the use of antipsychotics, antidepressants, and treatments for attention deficit/hyperactivity disorder (ADHD). In addition to examining changes in prescription and other health care use among non- elderly adults, we will also explore such changes among the children and the elderly, two subpopulations of particular relevance and concern. Finally, we will examine how firms modify their marketing and promotional strategies to providers and consumers in response to these communications. Our analyses, which will be rigorously conducted using advanced econometric techniques, will yield important information for policymakers and other stakeholders committed to ensuring the effective dissemination of safety information regarding these and other widely used classes of prescription drugs. PUBLIC HEALTH RELEVANCE: The FDA implements safety alerts and public health advisories to address emergent safety concerns for prescription drugs. Yet it is poorly understood how these warnings affect provider, patient, and firm behaviors, and hence, how effective these strategies are in minimizing risk. We will analyze a variety of complementary national databases using econometric methods to evaluate the effectiveness of these strategies and to identify factors that can improve risk communication, which will contribute to safeguarding the public health while maximizing clinical innovation.