Drug Abuse, Narcotic Abuse, Opiate Addiction, Opioid Related Disorders
Conditions
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.
Interventions
OTHERon-interventional study - retrospective database review
Sponsors
ER/LA Opioid REMS Program Companies (RPC)
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 100 Years
Inclusion criteria
* Subjects filling a prescription for a product of interest during the specified time period will be included.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed