Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,575,834
- 主要终点
- Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
研究概览
简要总结
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids
详细描述
A study will be performed to evaluate changes in prescribing behavior of prescribers.
- For products that are indicated for use in opioid-tolerant patients only (i.e., fentanyl transdermal patches, extended-release hydromorphone pills and extended-release morphine pills >90mg), describe trends in the proportion of prescriptions for these products to opioid-non-tolerant patients in the year preceding the availability of REMS-compliant CE courses and compare the proportion of prescriptions to opioid non-tolerant patients pre- versus post-REMS CE course availability
- For products whose labels indicate that higher dosage strengths should only be used in opioid-tolerant patients, describe trends in the proportion of prescriptions prescribed to opioid non-tolerant patients with a high starting dosage strength; compare the proportion of prescriptions for such products that are prescribed to opioid non-tolerant patients with a high starting dosage strength pre- versus post-REMS CE course availability
- Describe trends in the proportion of prescriptions for ER/LA opioids prescribed to patients that have early refills of prescriptions and compare this proportion pre- versus post-REMS CE course availability.
- Compare the concomitant use of benzodiazepines with ER/LA opioids before and after REMS implementation.
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
Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
时间窗: Monthly over 54 months
Monthly volume of opioid non-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
时间窗: Monthly over 54 months
Monthly volume of high-starting dose prescriptions in opioid-tolerant patients
时间窗: Monthly over 54 months
Monthly volume of high starting dose prescriptions in non-opioid tolerant patients
时间窗: Monthly over 54 months
Early refill rate by monthly patient cohort
时间窗: Monthly over 54 months
Monthly volume of patients who are using a REMS product and a Benzodiazepine concomitantly
时间窗: Monthly over 54 months
Proportion of opioid non-tolerant patients that have high-starting dose prescriptions
时间窗: Monthly over 54 months
Volume of early refills by monthly patient cohort
时间窗: Monthly over 54 months
Volume of normal refills (non-early refills) by monthly patient cohort
时间窗: Monthly over 54 months
Proportion of patients receiving early refills
时间窗: Monthly over 54 months
次要结局
未报告次要终点