Do Safety Warnings Change Prescribing among the US Dialysis Population?

描述（由申请人提供）：安全性检查是否会改变美国透析人群的处方？2007年3月9日，FDA发布了一项公共卫生咨询和黑盒警告，概述了新的安全性信息，包括修订了红细胞生成刺激剂（ESA）的产品标签，ESA是广泛使用的治疗肾病相关贫血的药物。本提案的目的是确定这些新建议是否导致医疗保险终末期疾病（ESRD）计划涵盖的所有美国透析患者的医生处方发生变化。方法计算机化的美国肾脏疾病系统（USRDS）的数据，从2006年3月至2009年3月，建议在FDA公共卫生咨询前一年和后两年的处方模式进行评估。基于所有表明使用ESA的门诊透析病例，将使用中断时间序列模型评估FDA黑箱试验对医生处方的影响。结果：我们将展示FDA警告前后ESA治疗肾衰竭相关贫血（常见于几乎所有透析患者）的趋势。我们将评估处方的变化是否可归因于FDA公共卫生咨询。结果将按患者人口统计学（年龄、种族、性别）、对治疗的反应性（达到血红蛋白>10 g/dL）、ESRD的原因（糖尿病、高血压等）分层，年份（透析时间长度）和设施特征（连锁地位、设施规模和利润状况）。结论/影响我们将展示是否两年后，一个高度宣传的FDS公共卫生咨询（黑盒警告，去了所有执业肾脏病学家），表明与ESA治疗和建议使用“最低剂量可能避免输血”的安全风险，导致在透析患者中观察到以前的高ESA剂量下降。使用“真实的世界”的处方数据，在一个人口普查的医疗保险ESRD患者的透析，我们将调查是否FDA的建议，从2007年3月的咨询会议是一致的变化，医生处方模式。我们将展示是否-在不伴随报销结构的变化，即，在我们的研究期间，更高剂量的ESA仍然有利可图--由于FDA的警告，医生改变了他们的ESA处方习惯。这项研究提供了一个独特的机会，以检查严重的黑盒警告的传播和医生的意愿，以修改处方习惯，在治疗弱势群体的透析患者。 公共卫生相关性：美国透析人群的安全性是否会改变处方？我们提出的研究为医生，决策者，政策制定者和整个社会提供了关于“诱发因素”的作用的关键信息，例如改变医生处方行为的专家咨询建议。鉴于AHRQ的强有力的和表现出的承诺，通过信息和思想的交流，应导致更多的访问和使用的道德医疗，以改善社会，这项研究将导致更好地了解健康和经济的结果，从使用一个昂贵的和有点争议的治疗。我们的研究特别提供了有关影响药物使用的因素的重要信息，特别是那些有安全问题的药物，如ESA。如何最好地处方某些药物，以提高其有效性以及减少其风险是具有挑战性的。FDA等政府机构和其他临床专家的建议被认为在这一竞技场中发挥着重要作用。我们的研究通过检查在专家小组建议和黑匣子警告之后的两年内是否有药物剂量下降来验证这一假设，该警告向所有执业肾病学家推荐“最低剂量的ESA治疗可能......”。".这项研究提供了一个独特的机会，以检查严重的黑盒警告的传播和医生的意愿，以修改处方习惯，在治疗弱势群体的透析患者。

DESCRIPTION (provided by applicant): Do Safety Warnings Change Prescribing among the U.S. Dialysis Population? Objectives on March 9, 2007, FDA issued a public health advisory and Black Box warning outlining new safety information, including revised product labeling about erythropoiesis- stimulating agents (ESAs), widely-used drugs for the treatment of anemia associated with renal disease. The goal of this proposal is to determine if these new recommendations resulted in a change in physician prescribing among all US dialysis patients covered by the Medicare End-Stage Disease (ESRD) program. Methods Computerized United States Renal Disease System (USRDS) data from March 2006 through March 2009 are proposed to evaluate prescribing patterns in the year before and two years after the FDA Public Health Advisory. An interrupted time series model, based on all outpatient dialysis encounters indicating use of ESAs will be used to assess the impact of the FDA Black Box Warnings in influencing physician prescribing. Results - We will show trends in prescribing of ESAs for anemia associated with renal failure (commonly found among nearly all dialysis patients) before and after the FDA warnings. We will assess whether changes in prescribing can be attributed to the FDA Public Health Advisory. Results will be stratified by patient demographics (age, race, gender), responsiveness to therapy (achieved hemoglobin >10 g/dL), cause of ESRD (diabetes, hypertension, etc.), vintage (length of time on dialysis), and facility characteristics (chain status, size of facility and profit status). Conclusions/Implications We will show whether two years after a highly publicized FDS Public Health Advisory (a Black Box Warning that went out to all practicing nephrologists) indicating the safety risks associated with ESA therapy and recommendations to use 'the lowest dose possible to avoid blood transfusions' resulted in a decline in the previously high ESA doses observed among dialysis patients. Using 'real world' prescription data among a census of Medicare ESRD patients on dialysis, we will investigate whether the FDA recommendations from the March 2007 advisory meeting were coincident with a change in physician prescribing patterns. We will show whether - without accompanying changes in the reimbursement structure, i.e., higher ESA doses continued to be profitable during our study period - physicians changed their ESA prescribing habits as a result of the FDA warnings. This study presents a unique opportunity to examine the dissemination of grave Black Box warnings and the willingness of physicians to modify prescribing habits in treating a vulnerable population of dialysis patients. PUBLIC HEALTH RELEVANCE: Do Safety Warnings Change Prescribing among the U.S. Dialysis Population? Our proposed study provides critical information to physicians, decision-makers, policymakers, and society overall regarding the role of 'predisposing factors' such as an expert advisory recommendation in changing physician prescribing behavior. Given AHRQ's strong and demonstrated commitment to the improvement of society through the exchange of information and ideas that should lead to greater access and usage of ethical medical treatments, this study will lead to a better understanding of the health and economic outcomes from use of an expensive and somewhat controversial therapy. Our study specifically provides important information regarding factors that influence use of drugs, particularly those with safety issues such as ESAs. How best to prescribe certain drugs to both enhance their effectiveness as well as to diminish their risks is challenging. Advice from government entities such as FDA and other clinical experts is thought to play an important role in this arena. Our study tests this hypothesis by examining whether there has been a decline in drug doses within a two year period following an expert panel recommendations and Black Box warnings that went out to all practicing nephrologists recommending "the lowest dose of ESA therapy possible....". This study presents a unique opportunity to examine the dissemination of grave Black Box warnings and the willingness of physicians to modify prescribing habits in treating a vulnerable population of dialysis patients.