Drug Abuse, Narcotic Abuse, Opioid Addiction, Opioid-related Disorders
Conditions
Brief summary
In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support national efforts to reduce serious adverse outcomes resulting from opioid abuse. This study will evaluate trends before and after the ER/LA REMS implementation for changes in mortality rates associated with prescription opioids utilizing state medical examiner databases from multiple states. Databases from 2005 through the most recent year available will be obtained.
Interventions
OTHERSurveillance of state medical examiner databases
Sponsors
ER/LA Opioid REMS Program Companies (RPC)
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
* Fatalities associated with prescription opioids in several states during 2005-2015 (or later).
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of fatalities associated with prescription opioids per size of population covered by the surveillance systems | Review over period from January 2005 to 2016 |
| Rates of fatalities associated with prescription opioids per number of prescriptions dispensed in the states | Review over period from January 2005 to 2016 |
Outcome results
None listed