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Counts and Proportions of New Users of Fentanyl Transdermal System with Evidence of Prior Opioid Tolerance

Basic Details
Date Posted
Status
Complete
Medical Product
fentanyl transdermal system
Description

This report provides the number and proportion of "opioid-tolerant-only" episodes of transdermal fentanyl that were prescribed to patients with evidence of prior‐established “opioid tolerance” by dose of transdermal fentanyl. This analysis only assesses the first eligible transdermal fentanyl episode per user, by dose. Data from January 1, 2009 to December 31, 2013 from 15 Data Partners contributing to the Mini-Sentinel Distributed Database (MSDD) were included in this report. The request was distributed to two Data Partners in March 2016 and to the remaining 13 participating Data Partners in April 2016.

Deliverables (1)
Mini-Sentinel Modular Program Report: Counts and Proportions of New Users of Fentanyl Transdermal System with Evidence of Prior Opioid Tolerance
Additional Details
FDA Center
CDER
Time Period
January 1, 2009 - December 31, 2013
Analysis Type
Mini-Sentinel
Population / Cohort
All individuals
Data Sources
Mini-Sentinel Distributed Database (MSDD)
Related Links
2017 ICPE Presentation: Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA's Sentinel System
Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA’s Sentinel System