ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases

• Conditions: Opioid Addiction; Drug Abuse; Opioid-related Disorders; Narcotic Abuse

• 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

Study Timeline

• Study First Submitted: 2016-08-10
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-07
• Last Update Submitted: 2016-09-07
• Study First Posted: 2016-09-13
• Last Update Posted: 2016-09-13
• Primary Completion: 2016-12

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

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