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Bosentan REMS requirements will change June 27, 2022

On April 29, 2022, the U.S. Food and Drug Administration approved a modification to the Bosentan Risk Evaluation and Mitigation Strategy (REMS) program. Beginning June 27, 2022, system changes for health care professionals will go into effect.

All stakeholders should find and document their enrollment ID or certification ID, username, and password, as well as confirm their email address is correct before June 24. This information is necessary to log into the new Bosentan REMS platform starting June 27. Please visit the Bosentan REMS website for instructions on finding your enrollment ID or certification ID and username. Communications from the Bosentan REMS will come from information@bosentanREMSprogram.org. Please check e-mail spam folders or mark information@bosentanREMSprogram.org as a safe sender.

Important changes for Health Care Providers:

Starting June 27, prescribers will be able to create a Prescriber Designee role to delegate certain REMS administrative activities to other members of their staff. Prescribers interested in creating a prescriber designee role can find more information on the Bosentan REMS website.

Important changes for Pharmacies:

The REMS administrator has changed, and the current “switch” within the pharmacy management system is being removed as a method to verify authorization to dispense bosentan. With the changes to the pharmacy management system, pharmacists will no longer have the option to use the switch system to obtain a pre-dispense authorization (PDA). Starting June 27, 2022, all pharmacists must obtain a PDA prior to dispensing bosentan by accessing the Bosentan REMS website or calling the Bosentan Contact Center.

Also starting June 27, pharmacists will be able to confirm patient testing results and enter or confirm patient counseling information through the Bosentan REMS website before obtaining a PDA.

The Bosentan REMS Contact Center and website will be unavailable during the system transition weekend, beginning 8:00pm ET Friday, June 24, 2022.

For complete information on the new Bosentan REMS requirements, please visit the Bosentan REMS website or call the Bosentan REMS Contact Center at 866-359-2612.

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