IMPACT OF "PILL MILL" LAWS ON OPIOID PRESCRIBING, DISPENSING AND UTILIZATION

描述(由申请人提供)：处方药滥用，特别是阿片类药物滥用的惊人增加，已引起致力于保护公众健康的利益攸关方的严重关切。国家调查和其他数据来源表明，滥用流行病不断升级，阿片类药物的使用、滥用、中毒和死亡之间存在明显的联系。此外，对于每一起虐待案件，都有更多的非医疗用途引起公共卫生问题。这些变化促使调查确定滥用的发生率以及增加患者滥用这些疗法的风险因素。此外，政策制定者一直在努力实施一些计划，这些计划可能会有效地减少非医疗用途，同时不会阻碍疼痛的临床适当治疗。各州正在越来越多地推行一种重要的立法，即所谓的“药厂”法，试图限制医疗保健诊所的业务，这些诊所开出的阿片类药物和其他受控药物处方数量高得不成比例。佛罗里达州在2011年实施了一项重要的立法，系统地监管了许多被挪用的处方药的根本来源，包括路易斯安那州、德克萨斯州和佐治亚州在内的其他州也颁布了类似的立法。佛罗里达州的法律特别令人感兴趣，因为佛罗里达州曾被认为是美国处方药滥用和转移的中心，它的“药厂”法律是美国最早和最全面的法律之一。我们提出了一系列相互关联的目标，利用独特的粒度数据来严格评估这些法律的效果。我们的调查充分利用了 从2006年到2013年，超过5000万美国人和150万处方者的大约52亿纵向处方索赔的数据库。这些数据特别适合于当前的分析，因为它们：收集所有支付来源的处方，包括现金支付；包括处方医生和药房标识，还包括牙医和护士等有执照的非医生开出的处方；纵向扩展到八年；反映感兴趣的州分配的所有处方的65%以上；允许进行细粒度的地理分析，并可以与其他数据结合起来检查政策效果。除了研究利益法则的总体影响外，我们还将表征它们对患者、处方医生和药房的影响，这些患者、处方师和药房的基线测量表明，它们的使用、处方或分配模式不寻常。我们的分析将严格使用先进的流行病学和统计技术进行。它们将为处方阿片类药物的药物监测提供分析方法，并将提供有关国家疼痛诊所法律法规对处方药滥用流行病学影响的重要信息。

DESCRIPTION (provided by applicant): Alarming increases in prescription drug abuse, especially of opioids, have led to grave concern among stakeholders working to protect the public's health. National surveys and other data sources indicate an escalating epidemic of abuse and a clear connection between opioid use, abuse, poisonings and deaths. Furthermore, for each case of abuse, there are many more cases of non-medical use that raise public health concerns. These changes have prompted investigations to characterize the incidence of abuse as well as risk factors that increase patients' misuse of these therapies. In addition, policy-makers have worked to implement programs that may be effective in reducing non-medical use while not obstructing clinically appropriate treatment of pain. One important type of legislation that states are increasingly pursuing, known as a "pill mill" law, attempts to restrict the clinica operations of health care clinics that account for disproportionately high volumes of opioid and other controlled substance prescribing. The state of Florida implemented significant legislation in 2011 that systematically regulates many of the root sources of prescription drugs that are diverted, and other states, including Louisiana, Texas and Georgia, have enacted similar legislation. Florida's law is of particular interest as Florida was once recognized as the epicente of prescription drug abuse and diversion in the U.S., and its "pill mill" law is one of the countrys earliest and most comprehensive. We propose a series of interrelated aims leveraging uniquely granular data to rigorously evaluate the effect of these laws. Our investigation capitalizes upon a database of approximately 5.2 billion longitudinal prescription claims for more than 50 million Americans and 1.5 million prescribers from 2006 through 2013. These data are particularly well suited for the current analyses, since they: capture prescriptions for all sources of payment including cash payment; include a prescriber and pharmacy identifier and also capture prescribing by licensed non-physicians such as dentists and nurse practitioners; extend longitudinally over an eight year period; reflect more than 65% of all prescriptions dispensed in the states of interest; and allow for granular geographic analyses and can be combined with other data to examine policy effects. In addition to examining the aggregate impact of the laws of interest, we will also characterize their effect on subsets of patients, prescribers and pharmacies whose baseline measures suggest unusual patterns of utilization, prescribing or dispensing. Our analyses will be rigorously conducted using advanced epidemiologic and statistical techniques. They will contribute analytic approaches to the pharmacosurveillance of prescription opioids and will yield important information regarding the effect of state laws and regulations for pain clinics on the epidemiology of prescription drug abuse.