Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers

ER/LA Opioid REMS Program Companies (RPC)

Status: Unknown

Conditions: Opiate Addiction; Drug Abuse; Narcotic Abuse; Opioid Related Disorders

Treatments: Other: on-interventional study - retrospective database review

Study type: Observational

Funder types: Industry

Identifiers

NCT02920762

Assessment 7

Details and patient eligibility

About

A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids

Full 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.

Enrollment: 5,575,834 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects filling a prescription for a product of interest during the specified time period will be included.

Exclusion criteria

• None

Trial design

5,575,834 participants in 8 patient groups

Buprenorphine

Treatment:

Other: on-interventional study - retrospective database review

Fentanyl

Treatment:

Other: on-interventional study - retrospective database review

Hydromorphone HCl

Treatment:

Other: on-interventional study - retrospective database review

Morphine Sulfate

Treatment:

Other: on-interventional study - retrospective database review

Morphine Sulfate Beads

Treatment:

Other: on-interventional study - retrospective database review

Oxycodone HCl

Treatment:

Other: on-interventional study - retrospective database review

Oxymorphone HCl

Treatment:

Other: on-interventional study - retrospective database review

Tapentadol

Treatment:

Other: on-interventional study - retrospective database review