ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning

• Conditions: Drug Abuse; Opioid-related Disorders; Opioid Addiction; Narcotic Abuse
• Interventions: Other: Retrospective database review

• Registration Number: NCT02866266
• Lead Sponsor: ER/LA Opioid REMS Program Companies (RPC)

Brief Summary

Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

Detailed Description

As part of the FDA-approved plan to evaluate the effects of the REMS program, the REMS Program Companies (RPC) are required to submit FDA assessment reports on a regular basis. The present study is one of several program evaluation components carried out in support Assessment 5: Surveillance monitoring for misuse, abuse, overdose, addiction, death and intervention taken. This study will evaluate the impact of the ER/LA opioid REMS program on the incidence of ED visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

Study Timeline

• Primary Completion: 2015-10
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 183452

Inclusion Criteria

1. At least one dispensing of an ER/LA opioid after 01 July 2010
2. At least six months of continuous health plan eligibility prior to the first recorded dispensing of an opioid that occurs during an included REMS period

Exclusion Criteria

1. Missing or implausible values for age
2. Missing or implausible values for gender

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Medicaid patients in a participating state Medicaid plan	Retrospective database review	-
All commercially insured patients in the HIRD	Retrospective database review	-

Primary Outcome Measures

Name	Time	Method
Number of ED visits for opioid overdose/poisoning and mortality	Retrospective review over period from July 2010 through December 2014
Number of hospitalizations for opioid overdose/poisoning and mortality	Retrospective review over period from July 2010 through December 2014

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	Retrospective review over period from July 2010 through December 2014