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

October 4, 2016 updated by: ER/LA Opioid REMS Program Companies (RPC)

Drug Utilization Study of Trends in Prescriptions for Class REMS ER/LA Opioids and Comparator Products; Evaluation of Drug Utilization Patterns

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

5575834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects filling a prescription for a product of interest as gathered from the IMS National prescription Audit™ and IMS Health, LifeLink™

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of opioid prescriptions filled
Time Frame: Monthly over 54 months
Monthly over 54 months
Compare average number of prescriptions per time period in the 2 years before as compared to the same measure in implementation and active periods
Time Frame: Pre REMS Implementation (July 10-June 12)
Pre REMS Implementation (July 10-June 12)
Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty
Time Frame: Pre REMS Implementation (July 10-June 12)
Pre REMS Implementation (July 10-June 12)
Number and Rate of Switches from ER/ LA opioids to comparator analgesics with introduction of REMS
Time Frame: Monthly over 54 months
Monthly over 54 months
Compare average number of prescriptions per time period in the 2 years before as compared to the same measure in implementation and active periods
Time Frame: Implementation (July 12-June 13)
Implementation (July 12-June 13)
Compare average number of prescriptions per time period in the 2 years before as compared to the same measure in implementation and active periods
Time Frame: Active Period (July 13-Dec 14)
Active Period (July 13-Dec 14)
Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty
Time Frame: Implementation (July 12-June 13)
Implementation (July 12-June 13)
Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty
Time Frame: Active Period (July 13-Dec 14)
Active Period (July 13-Dec 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ER/LA Opioid REMS Program Companies (RPC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Assessment 6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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