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

• Conditions: Drug Abuse; Opioid Related Disorders; Opiate Addiction; Narcotic Abuse

• Registration Number: NCT02920762
• Lead Sponsor: ER/LA Opioid REMS Program Companies (RPC)

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.

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-28
• Last Update Submitted: 2016-09-28
• Study First Posted: 2016-09-30
• Last Update Posted: 2016-09-30
• Primary Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5575834

Inclusion Criteria

• Subjects filling a prescription for a product of interest during the specified time period will be included.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of opioid non-tolerant patients that have high-starting dose prescriptions	Monthly over 54 months
Volume of early refills by monthly patient cohort	Monthly over 54 months
Proportion of patients receiving early refills	Monthly over 54 months
Monthly volume of opioid-tolerant patients prescribed products indicated for use only in opioid-tolerant patients	Monthly over 54 months
Monthly volume of opioid non-tolerant patients prescribed products indicated for use only in opioid-tolerant patients	Monthly over 54 months
Monthly volume of high-starting dose prescriptions in opioid-tolerant patients	Monthly over 54 months
Monthly volume of high starting dose prescriptions in non-opioid tolerant patients	Monthly over 54 months
Volume of normal refills (non-early refills) by monthly patient cohort	Monthly over 54 months
Early refill rate by monthly patient cohort	Monthly over 54 months
Monthly volume of patients who are using a REMS product and a Benzodiazepine concomitantly	Monthly over 54 months