Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers

ER/LA Opioid REMS Program Companies (RPC)

Status: Unknown

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

Treatments: Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion

Study type: Observational

Funder types: Industry

Identifiers

NCT02871232

Assessments 5.2-5.4

Details and patient eligibility

About

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.

Enrollment: 26,500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Any patient with data in the RADARS system

Exclusion criteria

None

Trial design

26,500 participants in 2 patient groups

Intentional exposures among adolescents and adults

Treatment:

Other: 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

Treatment:

Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion