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

ER/LA Opioid REMS Program Companies (RPC)

Status: Unknown

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

Treatments: Other: Retrospective database review

Study type: Observational

Funder types: Industry

Identifiers

NCT02866266

Assessment 5.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 183,452 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

183,452 participants in 2 patient groups

All commercially insured patients in the HIRD

Treatment:

Other: Retrospective database review

All Medicaid patients in a participating state Medicaid plan

Treatment:

Other: Retrospective database review