Extended Release/Long Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Medical Examiner Surveillance Monitoring Protocol
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 13,015
- Primary Endpoint
- Rates of fatalities associated with prescription opioids per number of prescriptions dispensed in the states
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Fatalities associated with prescription opioids in several states during 2005-2015 (or later).
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rates of fatalities associated with prescription opioids per number of prescriptions dispensed in the states
Time Frame: Review over period from January 2005 to 2016
Rates of fatalities associated with prescription opioids per size of population covered by the surveillance systems
Time Frame: Review over period from January 2005 to 2016
Secondary Outcomes
No secondary outcomes reported