Drug Abuse Clinical Trial
Official title:
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.
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
;
Observational Model: Cohort, Time Perspective: Retrospective
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