CompletedInterventionalNot ApplicableUpdated Jun 27, 2017
Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers | NCT02920762 | Trialant
Unknown statusObservationalUpdated Sep 30, 2016
Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
ClinicalTrials.gov ID
NCT02920762
Lead Sponsor
ER/LA Opioid REMS Program Companies (RPC)INDUSTRY
Overall Status
Unknown status
Study Type
Observational
Enrollment
5,575,834Estimated
Last Update Posted
Sep 30, 2016Estimated
Primary Completion Date
Jul 2019Estimated
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.
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
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
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.
Compare the concomitant use of benzodiazepines with ER/LA opioids before and after REMS implementation.
Opioid Related Disorders
Opiate Addiction
Narcotic Abuse
Drug Abuse
on-interventional study - retrospective database review
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No data available
Eligibility Criteria
Inclusion Criteria:
Subjects filling a prescription for a product of interest during the specified time period will be included.