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

• Conditions: Opiate Addiction; Opioid Related Disorders; Narcotic Abuse; Drug Abuse
• Interventions: Other: Non-interventional study - retrospective database review

• Registration Number: NCT02925806
• Lead Sponsor: ER/LA Opioid REMS Program Companies (RPC)

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2016-09-28
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-04
• Last Update Submitted: 2016-10-04
• Study First Posted: 2016-10-06
• Last Update Posted: 2016-10-06
• Primary Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5575834

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IR Opioids	Non-interventional study - retrospective database review	-
Celecoxib	Non-interventional study - retrospective database review	-
ER/LA opioids included in the class REMS	Non-interventional study - retrospective database review	-
Benzodiazepines	Non-interventional study - retrospective database review	-

Primary Outcome Measures

Name	Time	Method
Number of opioid prescriptions filled	Monthly over 54 months
Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty	Active Period (July 13-Dec 14)
Compare average number of prescriptions per time period in the 2 years before as compared to the same measure in implementation and active periods	Active Period (July 13-Dec 14)
Number and Rate of Switches from ER/ LA opioids to comparator analgesics with introduction of REMS	Monthly over 54 months