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Clinical Trial Summary

A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids


Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT02920762
Study type Observational
Source ER/LA Opioid REMS Program Companies (RPC)
Contact
Status Enrolling by invitation
Phase N/A

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