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

• Sponsor: ER/LA Opioid REMS Program Companies (RPC) (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02866266
• Collaborator: HealthCore, Inc. (Industry)
• Enrollment: 183,452

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-related Disorders; Opioid Addiction; Narcotic Abuse; Drug Abuse	Other: Retrospective database review

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 Design

• Study Type: Observational
• Actual Enrollment: 183452 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Extended Release (ER) / Long-acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Assessment 5.1: Surveillance of Emergency Department Visits and Hospitalizations for Opioid Overdose and Poisoning Events
• Actual Primary Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
All commercially insured patients in the HIRD	Other: Retrospective database review
All Medicaid patients in a participating state Medicaid plan	Other: Retrospective database review

Outcome Measures

Primary Outcome Measures

1. Number of ED visits for opioid overdose/poisoning and mortality [Retrospective review over period from July 2010 through December 2014]

2. Number of hospitalizations for opioid overdose/poisoning and mortality [Retrospective review over period from July 2010 through December 2014]

Secondary Outcome Measures

1. All-cause mortality [Retrospective review over period from July 2010 through December 2014]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ER/LA Opioid REMS Program Companies (RPC)
• HealthCore, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ER/LA Opioid REMS Program Companies (RPC)
• ClinicalTrials.gov Identifier: NCT02866266
• Other Study ID Numbers: Assessment 5.1
• First Posted: Aug 15, 2016
• Last Update Posted: Oct 5, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Emergencies; Substance-Related Disorders; Poisoning; Opioid-Related Disorders; Narcotic-Related Disorders

Study Results

No Results Posted as of Oct 5, 2016