Extended Release/Long Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Medical Examiner Surveillance Monitoring Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 13,015
- 主要终点
- Rates of fatalities associated with prescription opioids per number of prescriptions dispensed in the states
研究概览
简要总结
In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support national efforts to reduce serious adverse outcomes resulting from opioid abuse. This study will evaluate trends before and after the ER/LA REMS implementation for changes in mortality rates associated with prescription opioids utilizing state medical examiner databases from multiple states. Databases from 2005 through the most recent year available will be obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fatalities associated with prescription opioids in several states during 2005-2015 (or later).
排除标准
- 未提供
结局指标
主要结局
Rates of fatalities associated with prescription opioids per number of prescriptions dispensed in the states
时间窗: Review over period from January 2005 to 2016
Rates of fatalities associated with prescription opioids per size of population covered by the surveillance systems
时间窗: Review over period from January 2005 to 2016
次要结局
未报告次要终点