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

ER/LA Opioid REMS Program Companies (RPC)

Status: Unknown

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

Treatments: Other: Surveillance of state medical examiner databases

Study type: Observational

Funder types: Industry

Identifiers

NCT02897414

Assessment 5.5

Details and patient eligibility

About

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.

Enrollment: 13,015 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fatalities associated with prescription opioids in several states during 2005-2015 (or later).

Exclusion criteria

• None

Trial design

13,015 participants in 5 patient groups

Overall group of all ER/LA opioid excluding hydrocodone

Treatment:

Other: Surveillance of state medical examiner databases

Each type of opioid that has an ER/LA opioid formulation

Treatment:

Other: Surveillance of state medical examiner databases

Overall group that includes all prescription opioids except

Treatment:

Other: Surveillance of state medical examiner databases

Comparator Group taking benzodiazepines

Treatment:

Other: Surveillance of state medical examiner databases

Comparator Group taking IR hydrocodone

Treatment:

Other: Surveillance of state medical examiner databases