Clinical trial NCT02925806: Evaluation of Drug Utilization Patterns for Extended Release/Long Acting Opioids and Comparator Products
Official title: Drug Utilization Study of Trends in Prescriptions for Class REMS ER/LA Opioids and Comparator Products; Evaluation of Drug Utilization Patterns
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Related Disorders
Opiate Addiction
Narcotic Abuse
Drug Abuse
Lead sponsor: ER/LA Opioid REMS Program Companies (RPC)
Sponsor class: INDUSTRY
First posted: 2016-10-06
Enrollment: 5575834
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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™

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

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