Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers

• Conditions: Opioid-related Disorders; Drug Abuse; Opioid Addiction; Narcotic Abuse
• Interventions: Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion

• Registration Number: NCT02871232
• Lead Sponsor: ER/LA Opioid REMS Program Companies (RPC)

Brief Summary

To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-08-25
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26500

Inclusion Criteria

Any patient with data in the RADARS system

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intentional exposures among adolescents and adults	Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion	-
Unintentional exposures among infants and children	Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion	-

Primary Outcome Measures

Name	Time	Method
Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups	Review over period from January 2010 to December 2016

Secondary Outcome Measures

Name	Time	Method
Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group	Review over period from January 2010 to December 2016