Quantification and Characterization of Opioid Prescription, Overdose, and Fatalities in People with Cancer: A Massive Nationwide, Multi-Cohort Study

从20世纪90年代末开始的阿片类药物处方流行病在全国范围内大规模扩大，最终导致专业协会，医疗保健系统和立法机构采取措施遏制阿片类药物的不适当处方，特别是高剂量和长期使用。虽然其中一些具有显著和持续的总体影响，但对阿片类药物处方的趋势以及癌症幸存者人群的阿片类药物相关不良事件和死亡率的变化知之甚少。中度至重度癌症疼痛缓解阿片类药物治疗非常常见，随着癌症幸存者人口的持续增长，了解阿片类药物相关政策（即使是专门排除癌症患者的政策）如何影响获得适当的疼痛管理的必要性也在增加。该项目在两个不同的人群中使用匹配的纵向队列方法（美国退伍军人和医疗保险受益人），以便纵向和定量地描述癌症患者的以下变化：阿片类药物处方率和剂量、阿片类药物治疗的持续时间、阿片类药物的选择、阿片类药物相关住院和急诊就诊、阿片类药物滥用或依赖的新诊断，以及阿片类药物相关不良事件的ER访视或住院，药物辅助治疗（MAT）计划的入组情况以及阿片类药物过量事件的病死率。通过研究2008-2018年期间的这些事件，我们将能够评估医疗保健系统，州和联邦层面的阿片类药物相关指南，政策和法律的几波影响，以了解癌症患者如何受到美国对处方阿片类药物流行病的影响。最后，该研究的第二个目的是使用巢式病例对照研究来专门分析癌症患者与非癌症患者的阿片类药物过量事件，以描述致命过量的风险因素，包括获得处方阿片类药物。最终，该项目有可能弥合对癌症患者处方阿片类药物流行的理解方面的几个关键差距，这可以在短期内帮助患者和临床医生更好地评估阿片类药物治疗的风险和益处，并在长期内使政策制定者和专业协会能够更准确地了解阿片类药物相关政策对癌症患者的溢出效应。

The prescription opioid epidemic, beginning in the late 1990’s saw massive expansion of opioid prescriptions nationwide, ultimately leading professional societies, healthcare systems, and legislative bodies to take measures curbing inappropriate prescription of opioids, particularly at high doses and for chronic use. While some of these have had dramatic and sustained overall effects, there is little known about how trends in opioid prescription, nor opioid-related adverse events and mortality have changed for the cancer survivor population. Moderate to severe cancer pain warranting opioid therapy is very common, and as the cancer survivor population continues to grow, so too does the need to understand how opioid-related policies (even those specifically excluding people with cancer) has affected access to appropriate pain management. This project uses a matched longitudinal cohort methodology in two distinct populations (US veterans and Medicare beneficiaries) in order to longitudinally and quantitatively characterize in people with cancer changes in: opioid prescription rate and dosage, duration of opioid therapy, choices of opioids, opioid-related hospitalizations and emergency department visits, new diagnosis of opioid abuse or dependence, as well as ER visits or hospital admissions for opioid-related adverse events, enrollment in Medication-Assisted Treatment (MAT) programs, and the case fatality rate of opioid overdose events. By studying these events between 2008-2018, we will be able to evaluate the effects of several waves of opioid-related guidelines, policies, and laws at the healthcare system, state, and federal level to see how cancer patients have been affected by the US response to the prescription opioid epidemic. Finally, a second aim of the study will be to use a nested case-control study to specifically analyze opioid overdose events in people with cancer versus those who do not, in order to characterize risk factors for fatal overdoses, including access to prescription opioids. Ultimately, this project has the potential to close several key gaps in the understanding of the prescription opioid epidemic in people with cancer, which could in the immediate term help patients and clinician to better evaluate the risks and benefits of opioid therapy, and in the longer term allow policymakers and professional societies to have a more precise understanding of spillover effects of opioid-related policies on people with cancer.