Initiation of Transdermal Fentanyl Among US Commercially Insured Patients Between 2007 and 2015.

INTRODUCTION

This study examined patterns of initial transdermal fentanyl (TDF) claims among US commercially insured patients and explored the risk of 30-day hospitalization among patients with and without prior opioid exposure necessary to produce tolerance.

DESIGN

A retrospective cohort study of initial outpatient TDF prescriptions.

SETTING

A 10% random sample of commercially insured enrollees within the IQVIA Health Plan Claims Database (formerly known as PharMetrics Plus).

SUBJECTS

Individuals with a claim for TDF between 2007 and 2015.

METHODS

The primary exposure was a new transdermal fentanyl claim, and the primary outcome was guideline concordance based on time and dose exposure.

RESULTS

Among the 24,770 patients in the cohort, 4,848 (20%) patients had sufficient time exposure to opioids before TDF. Among those with sufficient time exposure, 3,971 (82%) had adequate opioid exposure based on the US Food and Drug Administration (FDA) package insert dosing guidance. Overall, 3,971 of the 24,770 (16%) patients received guideline-consistent TDF. An exploratory analysis of 30-day hospitalization after a TDF claim did not detect a difference in odds between guideline-consistent or -inconsistent groups when adjusted for variables known to influence the risk of opioid-induced respiratory depression.

CONCLUSIONS

A majority of patients met FDA opioid dose thresholds for TDF but had insufficient time exposure based on package insert recommendations for tolerance. Exploratory analysis did not detect a difference in odds for all-cause hospitalization or respiratory-related 30-day hospitalization between guideline-consistent or -inconsistent TDF claims. Prescribers should continue to adhere to FDA TDF labeling, although certain aspects of the labeling should be reevaluated or clarified.