NCT02897414

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

Extended Release/Long Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Medical Examiner Surveillance Monitoring Protocol

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 13,015 (estimated)
• Sponsor: ER/LA Opioid REMS Program Companies (RPC) · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Opioid-related Disorders
• Opioid Addiction
• Narcotic Abuse
• Drug Abuse

Interventions

Type	Name	Description
OTHER	Surveillance of state medical examiner databases

Timeline

• Primary completion: 2016-12-01
• First posted: 2016-09-13
• Last updated: 2016-09-13