Evaluation of Drug Utilization Patterns for Extended Release/Long Acting Opioids and Comparator Products

ER/LA Opioid REMS Program Companies (RPC)

Status: Unknown

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

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02925806

Assessment 6

Details and patient eligibility

About

A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products.

Full description

A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products.

The specific objectives of the Drug Utilization Study are:

1. To estimate trends by month in the number of prescriptions for a one-year period before, and each month after, the implementation of the REMS

2. To compare average number of prescriptions per 3 month (quarter) period in the 2 years before as compared to the same measure during Implementation and the Active Period

3. To evaluate change by patient characteristics (age group, gender, pay type, prescriber specialty)

4. To compare the trends in prescribing, both number of prescriptions and patients, by prescriber specialty

   These trends and changes over time will be estimated for the following groups of opioids:

   • ER/LA opioids included in the class REMS

   • Comparator products/classes

     • Immediate release (IR) opioids
     • Celecoxib
     • Benzodiazepines

5. To show switches (absolute and rates of switching) from ER/LA opioids to comparator analgesics (IR opioids or celecoxib) with introduction of REMS

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 4 patient groups

ER/LA opioids included in the class REMS

Treatment:

Other: Non-interventional study - retrospective database review

IR Opioids

Treatment:

Other: Non-interventional study - retrospective database review

Celecoxib

Treatment:

Other: Non-interventional study - retrospective database review

Benzodiazepines

Treatment:

Other: Non-interventional study - retrospective database review