Drug Utilization Study of Trends in Prescriptions for Class REMS ER/LA Opioids and Comparator Products; Evaluation of Drug Utilization Patterns
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,575,834
- 主要终点
- Number of opioid prescriptions filled
研究概览
简要总结
A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products.
详细描述
A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products.
The specific objectives of the Drug Utilization Study are:
- To estimate trends by month in the number of prescriptions for a one-year period before, and each month after, the implementation of the REMS
- To compare average number of prescriptions per 3 month (quarter) period in the 2 years before as compared to the same measure during Implementation and the Active Period
- To evaluate change by patient characteristics (age group, gender, pay type, prescriber specialty)
- To compare the trends in prescribing, both number of prescriptions and patients, by prescriber specialty
These trends and changes over time will be estimated for the following groups of opioids:
-
ER/LA opioids included in the class REMS
-
Comparator products/classes
-
Immediate release (IR) opioids
-
Celecoxib
-
Benzodiazepines
- To show switches (absolute and rates of switching) from ER/LA opioids to comparator analgesics (IR opioids or celecoxib) with introduction of REMS
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects filling a prescription for a product of interest during the specified time period will be included.
排除标准
- 未提供
结局指标
主要结局
Number of opioid prescriptions filled
时间窗: Monthly over 54 months
Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty
时间窗: Active Period (July 13-Dec 14)
Compare average number of prescriptions per time period in the 2 years before as compared to the same measure in implementation and active periods
时间窗: Active Period (July 13-Dec 14)
Number and Rate of Switches from ER/ LA opioids to comparator analgesics with introduction of REMS
时间窗: Monthly over 54 months
次要结局
未报告次要终点