Do Safety Warnings Change Prescribing among the US Dialysis Population?

描述（由申请人提供）：安全警告会改变美国透析人群的处方吗？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，包括红细胞生成刺激剂（ESAs）的修订产品标签，这是一种广泛用于治疗肾脏疾病相关贫血的药物。本提案的目的是确定这些新建议是否会导致医疗保险终末期疾病（ESRD）项目覆盖的所有美国透析患者的医生处方发生变化。方法采用美国肾脏疾病计算机化系统（USRDS） 2006年3月至2009年3月的数据，评估FDA公共卫生咨询发布前和发布后两年的处方模式。中断时间序列模型，基于所有门诊透析接触表明使用esa将用于评估FDA黑盒警告对医生处方的影响。结果：我们将展示在FDA警告之前和之后，针对肾功能衰竭相关贫血（在几乎所有透析患者中常见）开具esa处方的趋势。我们将评估处方的变化是否可归因于FDA公共卫生咨询。结果将根据患者人口统计学（年龄、种族、性别）、对治疗的反应性（达到血红蛋白10 g/dL）、ESRD病因（糖尿病、高血压等）、时间（透析时间长短）和设施特征（透析链状态、设施规模和利润状况）进行分层。结论/意义我们将显示，在高度宣传的FDS公共卫生咨询（向所有执业肾病学家发出的黑盒警告）表明ESA治疗相关的安全风险和建议使用“尽可能低剂量以避免输血”两年后，是否导致先前在透析患者中观察到的高ESA剂量下降。使用“真实世界”的处方数据，我们将调查2007年3月咨询会议上FDA的建议是否与医生处方模式的变化一致。我们将显示，在没有伴随报销结构变化的情况下，即在我们的研究期间，更高的ESA剂量继续有利可图，医生是否会因为FDA的警告而改变他们的ESA处方习惯。本研究提供了一个独特的机会来检查严重黑盒警告的传播和医生在治疗透析患者的弱势群体时修改处方习惯的意愿。

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.