Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
Study Details
Study Description
Brief Summary
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
A study will be performed to evaluate changes in prescribing behavior of prescribers.
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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
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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
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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.
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Compare the concomitant use of benzodiazepines with ER/LA opioids before and after REMS implementation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Buprenorphine
|
Other: on-interventional study - retrospective database review
|
| Fentanyl
|
Other: on-interventional study - retrospective database review
|
| Hydromorphone HCl
|
Other: on-interventional study - retrospective database review
|
| Morphine Sulfate
|
Other: on-interventional study - retrospective database review
|
| Morphine Sulfate Beads
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Other: on-interventional study - retrospective database review
|
| Oxycodone HCl
|
Other: on-interventional study - retrospective database review
|
| Oxymorphone HCl
|
Other: on-interventional study - retrospective database review
|
| Tapentadol
|
Other: on-interventional study - retrospective database review
|
Outcome Measures
Primary Outcome Measures
- 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]
- 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]
- Volume of normal refills (non-early refills) by monthly patient cohort [Monthly over 54 months]
- Proportion of patients receiving early refills [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subjects filling a prescription for a product of interest during the specified time period will be included.
Exclusion Criteria:
- None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- ER/LA Opioid REMS Program Companies (RPC)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Assessment 7