Benzodiazepine restrictions and the prevention of overdoses and other harms

项目摘要/摘要 在美国，苯二氮卓类药物的使用是独立的，苯二氮卓类药物是一种令人上瘾的常用处方药 与严重的健康后果有关，包括跌倒和骨折。苯二氮卓类药物也经常涉及 与阿片类药物相关的过量使用，强调了它们与目前美国阿片类药物流行的相关性。苯二氮卓类 过去已经实施了覆盖限制和其他监管行动，以减少 苯二氮卓类药物的使用和相关危害，尽管这些行动的有意和无意影响仍然存在 不清楚。其中一项具有国家影响的限制是将苯二氮卓类药物排除在 2006年实施联邦医疗保险D部分期间的联邦医疗保险参保人。与此同时，田纳西州 医疗补助(TennCare)计划对所有参与者的苯二氮卓类药物覆盖范围进行了限制。TennCare 是美国唯一这样做的州医疗补助计划。因此，TennCare参与者(包括Dual- 符合条件的人)从2006年到2013年没有医疗补助或医疗保险的苯二氮卓类药物保险， 当时这一限制被部分取消，然后在2014年完全取消。这种间歇性的限制 随后重新引入苯二氮类药物的覆盖范围是TennCare参与者独有的，并提供了 为确定苯二氮卓类药物限制对苯二氮卓类药物的影响的自然实验设置- 相关危害和其他精神药物的使用。拟议的工作将使用追溯 要检查的与Medicare Part D、生命记录和州住院数据相关的纵向TennCare数据 三个具体目标：目标1：检验2006年苯二氮卓类药物限制导致发病率较低的假设 有苯二氮类药物适应症的TennCare患者跌倒、骨折和阿片类药物相关过量的发生率 与没有苯二氮卓类药物适应症的患者进行比较。目标2：检验假设 2006年和2014年苯二氮类药物限制的实施和随后的取消导致了补偿 其他类似指示的精神药物的处方填充率的变化 Tenncare使用苯二氮卓类药物适应症的患者。目标3：检验这样一种假设：移除 2014年对苯二氮卓类药物的限制导致跌倒、骨折和阿片类药物相关过量的发生率较高 有苯二氮类药物适应症的患者与无苯二氮类药物适应症的患者的比较 使用。为拟议的工作和以药物为重点的独立研究方案的发展提供信息 在安全研究方面，候选人已经确定了具有相关专业知识的导师来监督额外的培训 (1)应用先进的差异设计评估状态的机会 政策变化，(2)使用苯二氮卓类药物和其他药物的患者的临床需求和护理障碍 精神药物；以及(3)索赔数据与其他临床和行政数据的大规模联系 消息来源。这项研究的发现将为未来减少苯二氮类药物和阿片类药物的战略提供参考。 相关危害，包括苯二氮类药物和阿片类药物相关的过量和死亡。

PROJECT SUMMARY/ABSTRACT The use of benzodiazepines, an addictive yet commonly prescribed class of drugs in the US, is independently linked to serious health outcomes, including falls and fractures. Benzodiazepines are also frequently involved in opioid-related overdoses, underscoring their relevance in the ongoing US opioid epidemic. Benzodiazepine coverage restrictions and other regulatory actions have been implemented in the past to reduce benzodiazepine use and related harms, though the intended and unintended impact of these actions remains unclear. One such restriction with national implications was the exclusion of benzodiazepines coverage for Medicare enrollees during the implementation of Medicare Part D in 2006. At the same time, the Tennessee Medicaid (TennCare) program instituted a restriction on benzodiazepine coverage for all enrollees. TennCare was the only State Medicaid program in the country to do so. Thus, TennCare enrollees (including dual- eligibles) did not have benzodiazepine coverage from either Medicaid or Medicare from 2006 through 2013, when the restriction was partially removed, and then completely removed in 2014. This intermittent restriction and subsequent reintroduction of benzodiazepine coverage is unique to TennCare enrollees and provides the setting for a natural experiment to determine the impact of benzodiazepine restrictions on benzodiazepine- related harms and the use of other psychotropic medications. The proposed work will use retrospective longitudinal TennCare data linked to Medicare Part D, Vital Records, and State hospitalization data to examine three specific aims: Aim 1: To test the hypothesis that benzodiazepine restrictions in 2006 led to a lower rate of falls, fractures and opioid-related overdoses among TennCare patients with indications for benzodiazepines use compared to patients without indications for benzodiazepines. Aim 2: To test the hypothesis that the implementation and subsequent removal of benzodiazepine restrictions in 2006 and 2014 led to compensatory changes in the rates of filled prescriptions for other similarly indicated psychotropic medications among TennCare patients with indications for benzodiazepine use. Aim 3: To test the hypothesis that the removal of benzodiazepine restrictions in 2014 led to a higher rate of falls, fractures and opioid-related overdoses among patients with indications for benzodiazepine use compared to patients without indications for benzodiazepine use. To inform the proposed work and the development of an independent research program focused on drug safety research, the candidate has identified mentors with relevant expertise to oversee additional training opportunities in (1) the application of advanced difference-in-difference designs for the evaluation of state policy changes, (2) the clinical needs and barriers to care among patients that use benzodiazepines and other psychotropic drugs, and (3) the large-scale linkage of claims data with other clinical and administrative data sources. Findings from this study will inform future strategies to reduce benzodiazepine- and opioid- related harms, including benzodiazepine and opioid-related overdoses and death.