Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
- Conditions
- Drug AbuseOpioid Related DisordersOpiate AddictionNarcotic Abuse
- Interventions
- Other: on-interventional study - retrospective database review
- Registration Number
- NCT02920762
- Lead Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 5575834
- Subjects filling a prescription for a product of interest during the specified time period will be included.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fentanyl 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 - Tapentadol on-interventional study - retrospective database review - Oxymorphone HCl on-interventional study - retrospective database review - Buprenorphine on-interventional study - retrospective database review - Hydromorphone HCl on-interventional study - retrospective database review -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method