Drug Abuse, Narcotic Abuse, Opioid Addiction, Opioid-related Disorders
Conditions
Brief 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.
Interventions
OTHERRetrospective database review
Sponsors
HealthCore, Inc.
ER/LA Opioid REMS Program Companies (RPC)
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
1. At least one dispensing of an ER/LA opioid after 01 July 2010 2. At least six months of continuous health plan eligibility prior to the first recorded dispensing of an opioid that occurs during an included REMS period
Exclusion criteria
1. Missing or implausible values for age 2. Missing or implausible values for gender
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of ED visits for opioid overdose/poisoning and mortality | Retrospective review over period from July 2010 through December 2014 |
| Number of hospitalizations for opioid overdose/poisoning and mortality | Retrospective review over period from July 2010 through December 2014 |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality | Retrospective review over period from July 2010 through December 2014 |
Outcome results
None listed