Extended Release (ER) / Long-acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Assessment 5.1: Surveillance of Emergency Department Visits and Hospitalizations for Opioid Overdose and Poisoning Events
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 183,452
- 主要终点
- Number of ED visits for opioid overdose/poisoning and mortality
研究概览
简要总结
Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
详细描述
As part of the FDA-approved plan to evaluate the effects of the REMS program, the REMS Program Companies (RPC) are required to submit FDA assessment reports on a regular basis. The present study is one of several program evaluation components carried out in support Assessment 5: Surveillance monitoring for misuse, abuse, overdose, addiction, death and intervention taken. This study will evaluate the impact of the ER/LA opioid REMS program on the incidence of ED visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one dispensing of an ER/LA opioid after 01 July 2010
- •At least six months of continuous health plan eligibility prior to the first recorded dispensing of an opioid that occurs during an included REMS period
排除标准
- •Missing or implausible values for age
- •Missing or implausible values for gender
结局指标
主要结局
Number of ED visits for opioid overdose/poisoning and mortality
时间窗: Retrospective review over period from July 2010 through December 2014
Number of hospitalizations for opioid overdose/poisoning and mortality
时间窗: Retrospective review over period from July 2010 through December 2014
次要结局
- All-cause mortality(Retrospective review over period from July 2010 through December 2014)