NCT02866266

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 183,452 (actual)
• Sponsor: ER/LA Opioid REMS Program Companies (RPC) · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Opioid-related Disorders
• Opioid Addiction
• Narcotic Abuse
• Drug Abuse

Interventions

Type	Name	Description
OTHER	Retrospective database review

Timeline

• Primary completion: 2015-10-01
• First posted: 2016-08-15
• Last updated: 2016-10-05