Probuphine® (buprenorphine) is only available through the Probuphine Risk Evaluation and Mitigation Strategy (REMS) Program, a restricted distribution program. Only prescribers and pharmacies enrolled in the program can prescribe, insert/remove, dispense and receive Probuphine. Before Probuphine is provided, pharmacies must:
1. Designate an authorized representative to carry out the certification
process and oversee implementation and compliance with the REMS
Program on behalf of the pharmacy.
2. Have the authorized representative enroll in the REMS Program by
completing the Pharmacy Enrollment Form and submitting it to the REMS
3. Train all relevant staff involved in dispensing that Probuphine is
dispensed only to healthcare settings in which a certified prescriber is
practicing and that the drug is not dispensed directly to the patient.
4. Establish processes and procedures to verify that Probuphine is provided
to a healthcare setting in which a certified prescriber is practicing and
the drug is not dispensed directly to the patient.
5. Verify that the prescriber who will receive the drug is certified to prescribe Probuphine.