ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases
- Conditions
- Opioid AddictionDrug AbuseOpioid-related DisordersNarcotic Abuse
- Interventions
- Other: Surveillance of state medical examiner databases
- Registration Number
- NCT02897414
- Lead Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 13015
Inclusion Criteria
- Fatalities associated with prescription opioids in several states during 2005-2015 (or later).
Exclusion Criteria
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Overall group of all ER/LA opioid excluding hydrocodone Surveillance of state medical examiner databases - Each type of opioid that has an ER/LA opioid formulation Surveillance of state medical examiner databases - Comparator Group taking benzodiazepines Surveillance of state medical examiner databases - Overall group that includes all prescription opioids except Surveillance of state medical examiner databases - Comparator Group taking IR hydrocodone Surveillance of state medical examiner databases -
- Primary Outcome Measures
Name Time Method Rates of fatalities associated with prescription opioids per number of prescriptions dispensed in the states Review over period from January 2005 to 2016 Rates of fatalities associated with prescription opioids per size of population covered by the surveillance systems Review over period from January 2005 to 2016
- Secondary Outcome Measures
Name Time Method