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Clinical Trials/NCT02920762
NCT02920762
Unknown
Not Applicable

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

ER/LA Opioid REMS Program Companies (RPC)0 sites5,575,834 target enrollmentSeptember 30, 2016

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2016
End Date
July 2019
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ER/LA Opioid REMS Program Companies (RPC)
Responsible Party
Sponsor

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

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