An observational study in Opioid-related Disorders, Opioid Addiction and Narcotic Abuse, sponsored by ER/LA Opioid REMS Program Companies (RPC). Status unknown. Per ClinicalTrials.gov, last updated 2016-10-05.
Sponsored by ER/LA Opioid REMS Program Companies (RPC) · Observational
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.
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.
209 studies on the registry are indexed under Poisoning; 26 are open to participants now.
This study's enrollment of 183,452 is above the median of 121 across 94 observational studies indexed under Poisoning.
Browse Poisoning studies →ER/LA Opioid REMS Program Companies (RPC) is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients that receive at least one dispensing of an ER/LA opioid during at least one study REMS period with at least six months of prior continuous health plan eligibility in the main analyses. Additional analyses will consider patients enrolled in the HIRD or a participating Medicaid plan regardless of ER/LA opioid exposure.
Exclusion Criteria:
Other: Retrospective database review
Other: Retrospective database review
Number of ED visits for opioid overdose/poisoning and mortality
Time frame: Retrospective review over period from July 2010 through December 2014
Number of hospitalizations for opioid overdose/poisoning and mortality
Time frame: Retrospective review over period from July 2010 through December 2014
All-cause mortality
Time frame: Retrospective review over period from July 2010 through December 2014
No study locations are listed for this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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ER/LA Opioid REMS Program Companies (RPC)