Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid Related Disorders
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
- Enrollment
- 5575834
- Primary Endpoint
- Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
- Last Updated
- 9 years ago
Overview
Brief Summary
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids
Detailed Description
A study will be performed to evaluate changes in prescribing behavior of prescribers. 1. 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 2. 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 3. 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. 4. Compare the concomitant use of benzodiazepines with ER/LA opioids before and after REMS implementation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects filling a prescription for a product of interest during the specified time period will be included.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
Time Frame: Monthly over 54 months
Monthly volume of opioid non-tolerant patients prescribed products indicated for use only in opioid-tolerant patients
Time Frame: Monthly over 54 months
Monthly volume of high-starting dose prescriptions in opioid-tolerant patients
Time Frame: Monthly over 54 months
Monthly volume of high starting dose prescriptions in non-opioid tolerant patients
Time Frame: Monthly over 54 months
Early refill rate by monthly patient cohort
Time Frame: Monthly over 54 months
Monthly volume of patients who are using a REMS product and a Benzodiazepine concomitantly
Time Frame: Monthly over 54 months
Proportion of opioid non-tolerant patients that have high-starting dose prescriptions
Time Frame: Monthly over 54 months
Volume of early refills by monthly patient cohort
Time Frame: Monthly over 54 months
Volume of normal refills (non-early refills) by monthly patient cohort
Time Frame: Monthly over 54 months
Proportion of patients receiving early refills
Time Frame: Monthly over 54 months