NCT02920762

Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,575,834 (estimated)
• Sponsor: ER/LA Opioid REMS Program Companies (RPC) · Industry
• Sex: All
• Age: 100 Years
• Healthy volunteers: —

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.

Conditions

• Opioid Related Disorders
• Opiate Addiction
• Narcotic Abuse
• Drug Abuse

Interventions

Type	Name	Description
OTHER	on-interventional study - retrospective database review

Timeline

• Primary completion: 2019-07-01
• First posted: 2016-09-30
• Last updated: 2016-09-30