Do Safety Warnings Change Prescribing among the US Dialysis Population?

美国透析人群中的安全性问题是否会改变处方？ 摘要 目标 2007年3月9日，FDA发布了一份公共卫生咨询和黑匣子警告， 新的安全性信息，包括关于红细胞生成的修订产品标签- 刺激剂（ESA），广泛使用的药物，用于治疗贫血相关的 肾脏疾病本提案的目标是确定这些新建议是否 导致美国所有透析患者的医生处方发生变化， 终末期疾病（ESRD）计划。 方法 2006年3月计算机化的美国肾脏疾病系统（USRDS）数据 到2009年3月，建议评估前一年的处方模式， 两年后，FDA公共卫生咨询。中断时间序列模型， 基于所有门诊透析治疗，表明使用ESA将用于评估 FDA黑盒计划对医生处方的影响。 结果 我们将展示ESA治疗肾衰竭相关贫血的处方趋势 （常见于几乎所有透析患者）在FDA警告之前和之后。 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）分层， 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），年份（透析时间长度）和设施特征（链 地位、设施规模和利润状况）。 结论/影响 我们将展示在高度宣传的FDS公共卫生咨询（a） 向所有执业肾脏科医生发出黑框警告），表明 与ESA治疗相关的风险和使用“尽可能低剂量”的建议 以避免输血，导致先前高剂量的ESA剂量下降， 在透析患者中观察到。使用“真实的世界”处方数据， 医疗保险ESRD患者透析，我们将调查FDA是否 2007年3月咨询会议的建议与一个变化相吻合， 医生的处方模式。我们将展示在没有陪同的情况下 报销结构的变化，即，更高的ESA剂量仍然是有利可图的 在我们的研究期间，医生改变了他们的ESA处方习惯， FDA警告这项研究提供了一个独特的机会，检查 传播严重的黑盒警告和医生愿意修改 在治疗脆弱的透析患者群体时的处方习惯。

Do Safety Warnings Change Prescribing among the US Dialysis Population? ABSTRACT 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.