Drug Abuse, Narcotic Abuse, Opioid Addiction, Opioid-related Disorders
Conditions
Brief summary
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.
Interventions
OTHERResearched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion
Sponsors
ER/LA Opioid REMS Program Companies (RPC)
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Inclusion criteria
Any patient with data in the RADARS system
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups | Review over period from January 2010 to December 2016 |
Secondary
| Measure | Time frame |
|---|---|
| Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group | Review over period from January 2010 to December 2016 |
Outcome results
None listed