User Manual Q&AAnswer
Jan 14, 2025 - 08:08 PM
The Bosentan REMS (Risk Evaluation and Mitigation Strategy) program is a safety program implemented for the medication Bosentan. It is designed to ensure safe use of Bosentan by minimizing the risks associated with its use, particularly the risks of hepatotoxicity (liver damage) and embryo-fetal toxicity.
An authorized representative, designated by a pharmacy, is responsible for overseeing the implementation of and compliance with the Bosentan REMS requirements. Their responsibilities include:
1. Reviewing the Pharmacy Guide: The authorized representative must review the Pharmacy Guide provided by the Bosentan REMS program to understand the requirements and guidelines.
2. Enrolling in the Bosentan REMS: The authorized representative must complete the Outpatient Pharmacy Enrollment Form and submit it to the Bosentan REMS to enroll their pharmacy in the program.
3. Training Staff: The authorized representative must ensure that all relevant staff involved in dispensing Bosentan are trained on the Bosentan REMS requirements using the Pharmacy Guide.
4. Obtaining Authorization for Dispensing: Before dispensing Bosentan, the pharmacy must contact the Bosentan REMS to verify various criteria, including patient enrollment, prescriber certification, completion of counseling and liver testing, and reproductive status for female patients.
5. Dispensing Limitations: The pharmacy must dispense no more than a 30-day supply of Bosentan to patients.
6. Documenting and Reporting: The pharmacy must document and submit confirmations of testing, counseling, and adverse events to the Bosentan REMS. They must also report pregnancies to the program.
7. Compliance and Record-Keeping: The pharmacy must maintain records of dispensing, training, and ensure that all processes and procedures are in place and being followed. They may also be subject to audits to ensure compliance.
8. Change of Authorized Representative: If there is a change in the authorized representative, the new representative must complete the Outpatient Pharmacy Enrollment Form to certify their participation in the Bosentan REMS.
By signing the enrollment form, the authorized representative acknowledges their understanding of the risks associated with Bosentan treatment and agrees to oversee the implementation of and compliance with the Bosentan REMS requirements for their pharmacy.
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