Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 9/7/17

Transmucosal Immediate-Release Fentanyl (TIRF) Products REMS

Goals of the TIRF Products REMS

The goals of the TIRF REMS Access program are to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by:

1. Prescribing and dispensing TIRF medicines only to appropriate patients, which includes use only in opioid-tolerant patients.

2. Preventing inappropriate conversion between TIRF medicines.

3. Preventing accidental exposure to children and others for whom it was not prescribed.

4. Educating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose of TIRF medicines.

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

• Implementation System

REMS Summary of Terms