Unintentional Poisoning from Prescription Drug Overdoses Among Veterans

退伍军人因过量服用处方药而意外中毒

• 批准号: 7760510
• 负责人: Matthew J Miller
• 金额: $ 17.48万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7760510
• 关键词: Unintentional; Poisoning; Prescription; Drug; Overdoses

DESCRIPTION (provided by applicant): Project Summary/Abstract The proposed research collaboration between the Harvard School of Public Health and the Massachusetts Veterans Epidemiology and Information Center is directly responsive to research objectives #3 and #7 of this FOA: to evaluate the effectiveness of FDA actions (#3), and to inform policy debate on prescription drug overdose prevention using secondary data analyses (#7). General Objectives: 1) To determine whether the risk of unintentional overdose associated with initiating opioid therapy applies equally to all opioid classes, agents, dosages, schedules and durations of use or whether there are particular regimens with safety advantages that should be prescribed preferentially; 2) To quantify the impact of recent FDA black box warnings on opioid prescribing practices. Importance: Physicians prescribe opioids in the near absence of sound empirical data about the risk of overdose associated with different opioid preparations. The proposed cohort study will generate clinically relevant data that could directly influence opioid prescribing decisions and guide future regulatory efforts. Specific Aims: 1. To examine the relationship between onset of prescription opioid use among users who have been newly prescribed these agents and subsequent development of non-fatal overdose. The study cohort consists of opioid users only. We will assess the extent to which risk of non-fatal overdose varies by the following exposure characteristics: a. Specific agent (Aim 1a). b. Duration of use (i.e., time from initiating opioid use) (Aim 1b). c. Duration of action (i.e., short vs. long acting agents) (Aim 1c). d. Dose (in codeine equivalents) (Aim 1d). e. Controlled substance schedule (i.e., II vs. III vs. IV) (Aim 1e) In addition, we will explore whether and if so how risk estimates (hazards ratios) depend on potential effect modifiers including socio-demographic factors, co-morbidity, co-medication, indication for opioid use, and facility characteristics (Aim 1f). We will also assess the extent to which any observed associations identified in Aims 1a-1f appear to be mediated by the development of substance use disorders after initial opioid use (Aim 1g). In secondary analyses, we will repeat sub-aims a-g for all-cause mortality and calculate incident rates for all-cause mortality by agent, duration of use, action, dose, and controlled substance schedule. 2. To assess the impact of the FDA's recent regulatory actions on opioid utilization. Using time trend analyses, we will quantify changes in the rate of use, starting, switching and stopping specific opioid regimens following FDA black box warnings for particular opioid preparations. We will assess the effect of particular warnings on the agent in question and on prescribing overall. Study Design: retrospective cohort study. Setting/Participants: The proposed cohort study uses health care utilization data on over one million new opioid users who are veterans receiving care within the Veterans Healthcare Administration (VHA) system nationally over an 11-year period, 1999-2009. Study subjects are identified using pharmacy and diagnostic information. Intervention: None. Outcome measures: 1) Non-fatal unintentional overdose events (identified in emergency department or outpatient visits or inpatient hospitalizations using ICD-9-CM codes); 2) all-cause mortality; 3) opioid utilization (identified using individual-level pharmacy records). PUBLIC HEALTH RELEVANCE: Project Narrative The proposed research has the potential to reduce the incidence of death and injury from unintentional overdose, a central objective of this FOA and of the CDC's mission more generally. Findings will provide physicians with new information to guide their opioid prescribing practices and regulatory agencies with information about the impact of black box warnings on prescribing generally, by sub-specialty, and by other relevant prescriber characteristics. Because this project involves a partnership with the Veterans Healthcare Administration (VHA), findings could lead to particularly prompt adoption of safer opioid prescribing practices for veterans receiving care within the VHA system.

描述（由申请人提供）： 项目总结/摘要 哈佛公共卫生学院和马萨诸塞州退伍军人流行病学和信息中心之间的拟议研究合作直接响应本FOA的研究目标#3和#7：评估FDA行动的有效性（#3），并使用二级数据分析为处方药过量预防的政策辩论提供信息（#7）。总体目标：1）确定与启动阿片类药物治疗相关的意外过量风险是否同样适用于所有阿片类药物类别、药物、剂量、时间表和使用持续时间，或者是否有具有安全优势的特定方案应优先处方; 2）量化最近FDA黑盒警告对阿片类药物处方实践的影响。重要性：医生在几乎没有关于与不同阿片制剂相关的过量风险的可靠经验数据的情况下开阿片类药物。拟议的队列研究将产生临床相关数据，这些数据可能直接影响阿片类药物处方决策，并指导未来的监管工作。具体目标：1。检查新处方阿片类药物的使用者开始使用处方阿片类药物与随后发生非致死性过量之间的关系。研究队列仅由阿片类药物使用者组成。我们将根据以下暴露特征评估非致命性过量风险的变化程度：a.特异性试剂（目标1a）。B.使用期限（即，开始使用阿片类药物的时间）（目标1b）。C.作用持续时间（即，短效剂与长效剂）（目标1c）。D.剂量（可待因当量）（Aim 1d）。e.受控物质时间表（即，II vs. III vs. IV）（目标1 e）此外，我们将探讨风险估计（风险比）是否以及如何取决于潜在效应修饰因素，包括社会人口统计学因素、合并症、合并用药、阿片类药物使用适应症和机构特征（目标1f）。我们还将评估在目标1a-1f中发现的任何观察到的相关性在多大程度上似乎是由最初使用阿片类药物后发生的物质使用障碍介导的（目标1g）。在次要分析中，我们将对全因死亡率重复子目标a-g，并按药物、使用持续时间、作用、剂量和受控物质时间表计算全因死亡率的发生率。2.评估FDA最近的监管行动对阿片类药物使用的影响。使用时间趋势分析，我们将量化在FDA针对特定阿片类药物制剂的黑盒警告后，特定阿片类药物治疗方案的使用率、开始、转换和停止的变化。我们将评估特定警告对相关药物和整体处方的影响。研究设计：回顾性队列研究。环境/参与者：这项拟议的队列研究使用了1999-2009年11年期间在全国退伍军人医疗保健管理局（VHA）系统内接受护理的100多万新阿片类药物使用者的医疗保健利用数据。使用药房和诊断信息识别研究受试者。发言：无。结局指标：1）非致命性意外用药过量事件（使用ICD-9-CM代码在急诊科或门诊就诊或住院治疗中识别）; 2）全因死亡率; 3）阿片类药物使用（使用个人水平药房记录识别）。 公共卫生相关性： 项目叙述拟议的研究有可能减少意外过量死亡和伤害的发生率，这是本FOA和CDC使命的中心目标。研究结果将为医生提供新的信息，以指导他们的阿片类药物处方实践，并为监管机构提供有关黑盒警告对处方的影响的信息，包括子专业和其他相关处方者特征。由于该项目涉及与退伍军人医疗保健管理局（VHA）的合作，研究结果可能会导致特别迅速地采用更安全的阿片类药物处方实践，为在VHA系统内接受护理的退伍军人提供服务。