What is the Probuphine REMS Program?
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure the benefits of a drug outweigh its risks. Fedson Inc.1 has worked with the FDA to develop the Probuphine REMS Program to mitigate the risk of complications of migration, protrusion, expulsion, and nerve damage associated with the insertion and removal of Probuphine and the risks of accidental overdose, misuse and abuse.
REMS Program Overview
- Training – for healthcare providers who prescribe, insert and remove Probuphine on steps to mitigate the risks of complications related to the insertion and removal procedures, and the risks of accidental overdose, misuse, and abuse.
- Certification – for healthcare providers who prescribe Probuphine by completing the Probuphine REMS Program Live Training: Lecture and Practicum, the Probuphine REMS Program Knowledge Assessment, and enrollment in the Probuphine REMS Program.
- Certification – for healthcare providers who perform Probuphine surgical procedures by completing the Probuphine REMS Program Live Training: Lecture and Practicum, the Probuphine REMS Program Knowledge Assessment, the Probuphine REMS Program Criteria for Procedural Competency and enrollment in the Probuphine REMS Program.
- Certification – for pharmacies who dispense Probuphine by completing the Probuphine REMS Pharmacy Enrollment Form and enrollment in the Probuphine REMS Program.
- Recertification – Fedson Inc. will notify clinicians in the database that the 12-month expiration of certification time point is approaching, and an attestation of having completed either online or live training for recertification will be required prior to placement of any additional orders from the healthcare provider. Use the Probuphine REMS Program Healthcare Provider Who Performs Probuphine Surgical Procedures Recertification Form to begin the recertification process. This form is available here or by clicking on the recertification button above. Healthcare providers will have a 30 day grace period to take corrective action to retain certification. If they are decertified they will need to attend the Probuphine REMS Program Live Training: Lecture and Practicum in order to regain certification.
- Patient Counseling – about the risks associated with the insertion and removal of Probuphine; the risks of accidental overdose, misuse, and abuse if the Probuphine implants come out or protrude from the skin; and when to contact the healthcare provider.
- Closed Distribution – only to healthcare providers and pharmacies certified in the Probuphine REMS Program.