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

Study Overview
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Brief Summary
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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
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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: 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 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 To evaluate change by patient characteristics (age group, gender, pay type, prescriber specialty) 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 To show switches (absolute and rates of switching) from ER/LA opioids to comparator analgesics (IR opioids or celecoxib) with introduction of REMS

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

Conditions
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Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse

Intervention / Treatment
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* Other: Non-interventional study - retrospective database review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects filling a prescription for a product of interest during the specified time period will be included. Exclusion Criteria: None

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ER/LA opioids included in the class REMS<br> | Other: Non-interventional study - retrospective database review<br> <br> |
| IR Opioids<br> | Other: Non-interventional study - retrospective database review<br> <br> |
| Celecoxib<br> | Other: Non-interventional study - retrospective database review<br> <br> |
| Benzodiazepines<br> | Other: Non-interventional study - retrospective database review<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of opioid prescriptions filled |  | 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 |  | Pre REMS Implementation (July 10-June 12) | 
| Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty |  | Pre REMS Implementation (July 10-June 12) | 
| Number and Rate of Switches from ER/ LA opioids to comparator analgesics with introduction of REMS |  | 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 |  | 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 |  | Active Period (July 13-Dec 14) | 
| Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty |  | Implementation (July 12-June 13) | 
| Compare trends in prescribing, both number of prescriptions and patients, by prescriber specialty |  | Active Period (July 13-Dec 14) |