REMS Program for Transmucosal Immediate-release Fentanyl Products is Operational, But Success Remains Uncertain

MAY 09, 2013
The FDA announced late in 2011 the approval of a single shared Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products. Covering rapid-onset opioid products indicated for the management of breakthrough pain (Abstral, Actiq, Fentora, Lazanda, Onsolis, and Subsys), the TIRF REMS Access program was designed to “ensure patient access to important medications” and mitigate the risk of misuse and medication-related errors by requiring that patients, prescribers, and pharmacies register in order to prescribe, dispense, or utilize any prescription fentanyl citrate product or its generic equivalent. The TIRF REMS Access program went live in March 2012.
In order to prescribe TIRF mediations in the outpatient setting, prescribers must first review the TIRF REMS Access Education Program (including the full prescribing information for each TIRF product), successfully complete the 11-question Knowledge Assessment (with a perfect score), and sign a prescriber enrollment form. Prescribers who write prescriptions for inpatient use only do not need to enroll in the TIRF REMS Access program.
To help ensure they make informed risk-benefit decisions before initiating treatment, providers are also required to “counsel the patient about the benefits and risks of TIRF medicines and together review the appropriate product-specific Medication Guide.” For each new patient, providers must also submit a completed TIRF REMS Access Program Patient-Prescriber Agreement Form, signed by them and the patient, within 10 days of the prescription being filled.

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