Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall group of all ER/LA opioid excluding hydrocodone |
| ||
| Each type of opioid that has an ER/LA opioid formulation |
| ||
| Overall group that includes all prescription opioids except |
| ||
| Comparator Group taking benzodiazepines |
| ||
| Comparator Group taking IR hydrocodone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveillance of state medical examiner databases | Other |
|
| Measure | Description | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Fatalities associated with prescription opioids as reported in State medical examiner databases from multiple states.
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided