Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
NCT ID: NCT02920762
Last Updated: 2016-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5575834 participants
OBSERVATIONAL
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Buprenorphine
on-interventional study - retrospective database review
Fentanyl
on-interventional study - retrospective database review
Hydromorphone HCl
on-interventional study - retrospective database review
Morphine Sulfate
on-interventional study - retrospective database review
Morphine Sulfate Beads
on-interventional study - retrospective database review
Oxycodone HCl
on-interventional study - retrospective database review
Oxymorphone HCl
on-interventional study - retrospective database review
Tapentadol
on-interventional study - retrospective database review
Interventions
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on-interventional study - retrospective database review
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
100 Years
ALL
No
Sponsors
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ER/LA Opioid REMS Program Companies (RPC)
INDUSTRY
Responsible Party
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Other Identifiers
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Assessment 7
Identifier Type: -
Identifier Source: org_study_id