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

September 7, 2016 updated by: ER/LA Opioid REMS Program Companies (RPC)

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

13015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Fatalities associated with prescription opioids as reported in State medical examiner databases from multiple states.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Overall group of all ER/LA opioid excluding hydrocodone
Other: Surveillance of state medical examiner databases
Each type of opioid that has an ER/LA opioid formulation
Other: Surveillance of state medical examiner databases
Overall group that includes all prescription opioids except
Other: Surveillance of state medical examiner databases
Comparator Group taking benzodiazepines
Other: Surveillance of state medical examiner databases
Comparator Group taking IR hydrocodone
Other: Surveillance of state medical examiner databases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Review over period from January 2005 to 2016
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
Review over period from January 2005 to 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ER/LA Opioid REMS Program Companies (RPC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Assessment 5.5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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