Changes to which Drugs and Drug Combinations are Prescribed in Response to Opioid Supply-side Policies

为响应阿片类药物供应方政策而改变药物和药物组合的处方

• 批准号: 10302495
• 负责人: Evan David Peet
• 金额: $ 28.23万
• 依托单位: RAND CORPORATION
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10302495
• 关键词: AIDS/HIV problem; Abnormal coordination; Address; Affect; American; Area; Benzodiazepines; Cause of Death; Centers for Disease Control and Prevention (U.S.); Characteristics; Data; Databases; Drug Combinations; Drug Prescriptions; Effectiveness; Electronic Tracking Database; Face; Federal Government; Fentanyl; Growth; Health; Heroin; Heterogeneity; Homicide; Hypertension; Individual; Information Centers; Interruption; Label; Link; Literature; Mandatory Reporting; Medicare; Methods; Opioid; Outcome; Overdose; Pain; Patients; Pattern; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Physicians; Placebos; Pneumonia; Policies; Prevalence; Public Health; Reporting; Research; Risk; Risk Factors; Role; Safety; Series; Side; State Government; Testing; Time; Variant; addiction; differences in access; dosage; experimental study; federal policy; gabapentin; illicit drug use; illicit opioid; improved; indexing; mortality; non-opioid analgesic; novel; off-label use; opioid abuse; opioid epidemic; opioid misuse; opioid mortality; opioid overdose; opioid policy; overdose death; pain relief; population health; prescription monitoring program; prescription opioid; prescription pain reliever; pressure; response; side effect; synthetic opioid; tool; trend; years of life lost

ABSTRACT Claiming the lives of nearly 400,000 Americans between 1999 and 2017, drug overdoses caused by the misuse of and addiction to opioids – including prescription pain relievers, heroin, and synthetic opioids such as fentanyl – have become a major public health crisis in the U.S. In response to the crisis, state and federal governments have enacted many policies, mostly targeting the supply-side to restrict the issuance of prescriptions. However, physicians face persistent patient demand for pain relief. Consequently, as supply-side policies restrict opioid prescriptions, physicians’ pharmacologic options to address patient demand are limited, including: 1) supplement opioids with off-label, concomitant prescriptions, and 2) prescribe nonopioid pharmaceutical substitutes. In this exploratory R21 we will examine how the policies aimed at addressing the opioid crisis have changed physicians’ prescribing patterns. Preliminary evidence indicates that prescriptions of nonopioid alternatives have been increasing, as have concomitant prescriptions of opioids with benzodiazepines or gabapentinoids. However, there is, according to our knowledge, no empirical evidence linking these trends to the opioid supply-side policies. Accordingly, our study will break new ground in our understanding of how physicians are attempting to meet patient demand for pain relief while facing increasing opioid prescription restrictions. The supply-side policy that we will focus on is Prescription Drug Monitoring Programs (PDMPs). We will use the RAND Opioid Policy and Tools Information Center (OPTIC) database which documents policies related to opioid prescribing, as well as the Truven Health MarketScan (2005-2020) database of commercial and Medicare prescription drug claims, and the Centers for Disease Control’s Multiple Cause of Death (MCOD) data. With this combination of data, we will first examine the effects of PDMPs on the concomitant prescription of opioids with benzodiazepines or gabapentinoids. Then, we will explore PDMPs’ effects on the prescription of nonopioid substitute pharmaceuticals. Finally, we will examine the population health effects, specifically the effects of PDMPs on fatal overdoses – all fatal overdoses, those involving opioids (both licit and illicit), and those involving combinations of opioids with benzodiazepines or gabapentinoids. For each aim, we will leverage state- year variation in the timing of PDMP implementation and use the controlled interrupted time series method. Additionally, we will perform descriptive analyses (e.g. trends), robustness checks (e.g. alternative outcome specifications such as dosage and duration), and heterogeneity analyses (e.g. different effects of PDMP types). While PDMPs have been studied with regards to their effects on opioid prescriptions, the existing literature does not consider the role of PDMPs in the prescription of benzodiazepines, gabapentinoids, and nonopioid pharmaceutical substitutes despite recent FDA warnings and evidence of the increasingly frequent involvement of these substances in overdose fatalities. Thus, this exploratory R21 will begin an important and novel research into physician responses to opioid supply-side policies.

摘要 1999年至2017年期间，近40万美国人因滥用药物过量而丧生 阿片类药物成瘾-包括处方止痛药，海洛因和合成阿片类药物，如芬太尼 - 已经成为美国的一个主要公共卫生危机。为了应对这一危机，州和联邦政府 出台了很多政策，多是针对供应方，限制处方的发放。然而，在这方面， 医生面临患者对疼痛缓解的持续需求。因此，随着供应方政策限制阿片类药物 处方，医生的药理学选择，以解决病人的需求是有限的，包括：1） 用标签外伴随处方补充阿片类药物，和2）处方非阿片类药物 替代品在这个探索性的R21中，我们将研究旨在解决阿片类药物危机的政策如何 改变了医生的处方模式初步证据表明，非阿片类药物的处方 替代品一直在增加，同时使用阿片类药物和苯二氮卓类药物处方， 加巴喷丁。然而，据我们所知，没有经验证据表明这些趋势与 阿片类药物供应方政策。因此，我们的研究将在我们理解如何 医生们正试图满足病人对止痛的需求，同时面临着越来越多的阿片类药物处方， 限制.我们将重点关注的供应方政策是处方药监测计划（PDMP）。 我们将使用记录政策的兰德阿片类药物政策和工具信息中心（OPTIC）数据库 以及Truven Health MarketScan（2005-2020年）商业和 医疗保险处方药索赔，以及疾病控制中心的多死因（MCOD）数据。 有了这些数据，我们将首先检查PDMP对伴随处方的影响， 阿片类与苯二氮卓类或加巴喷丁类。然后，我们将探讨PDMP对处方的影响， 非阿片类药物替代品。最后，我们将研究人口健康的影响，特别是 PDMP对致命过量的影响-所有致命过量，涉及阿片类药物（合法和非法）的药物，以及 涉及阿片类与苯二氮卓类或加巴喷丁类的组合。对于每一个目标，我们将利用国家- 年变化的时间PSTs实施和使用受控中断时间序列方法。 此外，我们将进行描述性分析（例如趋势）、稳健性检查（例如替代结局 规格，如剂量和持续时间），和异质性分析（如不同类型的PAPs的不同影响）。 虽然已经研究了PDMP对阿片类药物处方的影响，但现有文献确实 不考虑PDMP在苯二氮卓类、加巴喷丁类和非阿片类药物处方中的作用 尽管最近FDA警告和越来越频繁的参与证据， 这些物质在过量死亡中的作用因此，这一探索性的R21将开始一项重要而新颖的研究 医生对阿片类药物供应方政策的反应。