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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.
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
To show switches (absolute and rates of switching) from ER/LA opioids to comparator analgesics (IR opioids or celecoxib) with introduction of REMS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ER/LA opioids included in the class REMS |
| ||
| IR Opioids |
| ||
| Celecoxib |
| ||
| Benzodiazepines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional study - retrospective database review | Other |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects filling a prescription for a product of interest as gathered from the IMS National prescription Audit™ and IMS Health, LifeLink™
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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