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Clinical Trial 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.


Clinical Trial 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

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT02866266
Study type Observational
Source ER/LA Opioid REMS Program Companies (RPC)
Contact
Status Active, not recruiting
Phase N/A

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