Drug Abuse, Narcotic Abuse, Opiate Addiction, Opioid Related Disorders
Conditions
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
Interventions
Sponsors
ER/LA Opioid REMS Program Companies (RPC)
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 100 Years
Inclusion criteria
* Subjects filling a prescription for a product of interest during the specified time period will be included.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed