Bosentan REMS Program Pharmacy Types and Definitions
All outpatient, chain, and inpatient pharmacies must certify in the Bosentan REMS Program to purchase and dispense bosentan.
Pharmacy staff must enroll in the Bosentan REMS Program to obtain a Pre-dispense Authorization (PDA) or to perform an inpatient REMS requirements check from the REMS website. For more information on the pharmacy staff enrollment process, please go to Pharmacy Staff Enrollment.
Pharmacies participating in the Bosentan REMS Program must determine their pharmacy type based on the definitions below:
Pharmacy Type Definition
Outpatient Pharmacy For the purposes of this REMS outpatient pharmacies include but are not limited to retail, specialty, mail order, and closed system pharmacies.
Chain Pharmacy For the purposes of this REMS chain pharmacies are retail pharmacies with multiple locations that dispense bosentan for outpatient use and have a pharmacy headquarters that coordinates pharmacy enrollment in the Bosentan REMS Program.
Inpatient Pharmacy For the purposes of this REMS Inpatient pharmacies include but are not limited to pharmacies in hospitals, hospices, long-term care facilities, and prisons.
To become certified, pharmacies must designate an authorized representative to complete enrollment. An authorized representative for a pharmacy may be, but is not limited to:
  • Pharmacy Manager
  • Staff Pharmacist
  • Director of Pharmacy Services
  • Corporate Executive overseeing Pharmacy Services
In general, an authorized representative for a pharmacy:
  • Coordinates the activities required for the pharmacy and/or pharmacy staff in the Bosentan REMS Program.
  • Establishes and implements processes and procedures to ensure compliance with the safe use conditions of the Bosentan REMS Program.
  • Maintains documentation that all processes and procedures are in place and are being followed for the Bosentan REMS Program and provide upon request to the Bosentan Sponsors, or a third party acting on behalf of the Bosentan Sponsors.
  • Complies with audits by the Bosentan Sponsors, or a third party acting on behalf of the Bosentan Sponsors to ensure that all processes and procedures are in place and are being followed for the Bosentan REMS Program.
Note: Pharmacies must recertify in the Bosentan REMS Program if the pharmacy designates a new authorized representative.
Select your pharmacy type below for more information.
The authorized representative for each outpatient pharmacy must complete the following steps in the Bosentan REMS Program:
Expand all

1. READ

READ the Prescribing Information for bosentan and Medication Guide and the Bosentan REMS Program Pharmacy Guide to understand the risks of bosentan and to learn about the Bosentan REMS Program

  • The authorized representative for the pharmacy must understand the risks of bosentan and become familiar with the Bosentan REMS Program, prior to certifying their pharmacy

2. ENROLL

ENROLL the pharmacy by completing the Bosentan REMS Program Outpatient Pharmacy Enrollment Form

  • By signing the form, the authorized representative attests to understanding the risks of bosentan and agrees to comply with the Bosentan REMS Program as described in the Bosentan REMS Program Outpatient Pharmacy Enrollment Form
  • The authorized representative can complete the enrollment forms online or download the form here and fax the form to the Bosentan REMS Program at 1-800-730-8231
    • If your outpatient pharmacy supports electronic verification with the Bosentan REMS Program system, during the enrollment process your authorized representative will be instructed to verify the pre-dispense authorization (PDA) is operational using established telecommunication standards, and by running the standardized validation test transactions to validate the system enhancements

3. TRAIN

TRAIN all pharmacy staff who participate in dispensing bosentan on the Bosentan REMS Program requirements

  • Prior to dispensing bosentan, the authorized representative must ensure that all pharmacy staff who participate in dispensing bosentan are educated on the risks associated with bosentan and the requirements of the Bosentan REMS Program as defined in the Bosentan REMS Program Outpatient Pharmacy Enrollment Form
  • Any pharmacy employee may assume the role of a pharmacy staff member and associate with a certified outpatient pharmacy by accessing the Bosentan REMS Program Website
    • Pharmacy staff in outpatient pharmacies that do NOT support electronic communication verification with the Bosentan REMS Program system will be able to request a PDA

4. DOCUMENT

DOCUMENT all staff training

  • Certified pharmacies are subject to audit by Bosentan Sponsors or a third party acting on behalf of Bosentan Sponsors to ensure that all processes and procedures are in place and are being followed for the Bosentan REMS Program.

5. VERIFY SAFE USE CONDITIONS

VERIFY SAFE USE CONDITIONS for each patient prior to dispensing bosentan

  • Outpatient pharmacies must obtain a pre-dispense authorization (PDA) prior to dispensing bosentan to a patient
    • If your outpatient pharmacy supports electronic telecommunication verification with the Bosentan REMS Program system, your pharmacy must dispense bosentan to patients only after obtaining a PDA through your pharmacy management system
    • If your outpatient pharmacy does NOT support electronic telecommunication verification with the Bosentan REMS Program system, your pharmacy must dispense bosentan to patients only after obtaining a PDA by calling the Bosentan REMS Program Contact Center or accessing the Bosentan REMS Program Website
    • If a PDA is not issued, prior to dispensing bosentan the outpatient pharmacy may perform the corresponding activity to address the reasons that a PDA was not issued:
      • Certify the pharmacy in the Bosentan REMS Program
      • Contact the prescriber or the Bosentan REMS Program to notify the prescriber that certification is required in the Bosentan REMS Program before bosentan can be dispensed
      • Contact the prescriber or the Bosentan REMS Program to notify the prescriber that the patient must be enrolled in the Bosentan REMS Program before bosentan can be dispensed
      • If a PDA is not issued because required testing is not confirmed, the outpatient pharmacy can call the Bosentan REMS Program Contact Center at 1-866-359-2612 to confirm with the patient or the patient's prescriber that the testing has been completed before bosentan can be dispensed
    • If counseling is not confirmed in the Bosentan REMS Program, a PDA will be issued if all other safe use conditions are met. The pharmacy must call the Bosentan REMS Program Contact Center to complete the counseling requirement before bosentan is dispensed. The Contact Center will provide counseling guidelines to the pharmacy. The pharmacy is required to counsel the patient according to the guidelines from the Contact Center
      • The Contact Center agents will be available during normal business hours. The Contact Center agent will provide the counseling guidelines and document the counseling
      • An interactive voice response system will be available 24/7. The system will provide the counseling guidelines and document the counseling

6. DISPENSE

DISPENSE up to a 30-day supply, along with a copy of the Medication Guide for the bosentan product that is dispensed

  • Up to a 90-day supply may be dispensed with a refill dispense exception authorized by the prescriber for extended travel outside of the United States of more than 30 days

7. NOT TRANSFER BOSENTAN

NOT TRANSFER BOSENTAN to any pharmacy, practitioner, or any healthcare setting not certified in the Bosentan REMS Program

8. NOTIFY

NOTIFY the Bosentan REMS Program of all adverse events including those suggestive of hepatotoxicity

9. REPORT

REPORT any pregnancy and all available information during treatment with bosentan to the Bosentan REMS Program

The authorized representative for the chain pharmacy must complete the following steps in the Bosentan REMS Program:
Expand all

1. READ

READ the Prescribing Information for bosentan and Medication Guide and the Bosentan REMS Program Pharmacy Guide to understand the risks of bosentan and to learn about the Bosentan REMS Program

  • The authorized representative for the pharmacy must understand the risks of bosentan and become familiar with the Bosentan REMS Program, prior to certifying their pharmacy

2. ENROLL

ENROLL the chain pharmacy by completing the Bosentan REMS Program Chain Pharmacy Headquarters Enrollment Form

  • By signing the form, the authorized representative attests to understanding the risks of bosentan and agrees to comply with the Bosentan REMS Program as described in the Bosentan REMS Program Chain Pharmacy Headquarters Enrollment Form
  • The authorized representative can complete the enrollment forms online or download the form here and fax the form to the Bosentan REMS Program at 1-800-730-8231
  • Ensure the pharmacy enables its pharmacy management system to support communication with the Bosentan REMS Program system, using established telecommunication standards, and runs the standardized validation test transactions to validate the system enhancements

3. TRAIN

TRAIN all pharmacy staff who participate in dispensing bosentan on the Bosentan REMS Program requirements

  • Prior to dispensing bosentan, the authorized representative must ensure that all pharmacy staff who participate in dispensing bosentan are educated on the risks associated with bosentan and the requirements of the Bosentan REMS Program as defined in the Bosentan REMS Program Chain Pharmacy Headquarters Enrollment Form

4. DOCUMENT

DOCUMENT all staff training

  • Once each dispensing location is trained, it is the authorized representative's responsibility to report confirmation of training to the Bosentan REMS Program online through www.BosentanREMSProgram.com, or by contacting the Bosentan REMS Program Contact Center at 1-866-359-2612 to obtain instructions on providing a list of trained pharmacy locations. Once the Bosentan REMS Program confirms the required dispensing information, the dispensing location will be authorized to purchase, receive, and dispense bosentan
  • Certified pharmacies are subject to audit by Bosentan Sponsors or a third party designated by Bosentan Sponsors to ensure that all processes and procedures are in place and are being followed for the Bosentan REMS Program

5. VERIFY SAFE USE CONDITIONS

VERIFY SAFE USE CONDITIONS for each patient prior to dispensing bosentan

  • Chain pharmacies must dispense bosentan to patients only after obtaining a pre-dispense authorization (PDA) by processing the prescription, including cash claims, through their pharmacy management system.
    • If a PDA is not issued, prior to dispensing bosentan the pharmacy may perform the corresponding activity to address the reasons that a PDA was not issued:
      • Certify the pharmacy in the Bosentan REMS Program
      • Contact the prescriber or the Bosentan REMS Program to notify the prescriber that certification is required in the Bosentan REMS Program before bosentan can be dispensed
      • Contact the prescriber or the Bosentan REMS Program to notify the prescriber that the patient must be enrolled in the Bosentan REMS Program before bosentan can be dispensed
      • If a PDA is not issued because required testing is not confirmed, the outpatient pharmacy can call the Bosentan REMS Program Contact Center at 1-866-359-2612 to confirm with the patient or the patient's prescriber that the testing has been completed before bosentan can be dispensed
    • If counseling is not confirmed in the Bosentan REMS Program, a PDA will be issued if all other safe use conditions are met. The pharmacy must call the Bosentan REMS Program Contact Center to complete the counseling requirement before bosentan is dispensed. The Contact Center will provide counseling guidelines to the pharmacy. The pharmacy is required to counsel the patient according to the guidelines from the Contact Center
      • The Contact Center agents will be available during normal business hours. The Contact Center agent will provide the counseling guidelines and document the counseling
      • An interactive voice response system will be available 24/7. The system will provide the counseling guidelines and document the counseling

6. DISPENSE

DISPENSE up to a 30-day supply, along with a copy of the Medication Guide for the bosentan product that is dispensed

  • Up to a 90-day supply may be dispensed with a refill dispense exception authorized by the prescriber for extended travel outside of the United States of more than 30 days

7. NOT TRANSFER BOSENTAN

NOT TRANSFER BOSENTAN to any pharmacy, practitioner, or any healthcare setting not certified in the Bosentan REMS Program

8. NOTIFY

NOTIFY the Bosentan REMS Program of all adverse events including those suggestive of hepatotoxicity

9. REPORT

REPORT any pregnancy and all available information during treatment with bosentan to the Bosentan REMS Program

The authorized representative for each inpatient pharmacy must complete the following steps in the Bosentan REMS Program:
Expand all

1. READ

READ the Prescribing Information for bosentan and Medication Guide and the Bosentan REMS Program Pharmacy Guide to understand the risks of bosentan and to learn about the Bosentan REMS Program

  • The authorized representative for the pharmacy must understand the risks of bosentan and become familiar with the Bosentan REMS Program, prior to certifying their pharmacy

2. ENROLL

ENROLL the pharmacy by completing the Bosentan REMS Program Inpatient Pharmacy Enrollment Form

  • By signing the form, the authorized representative attests to understanding the risks of bosentan and agrees to comply with the Bosentan REMS Program as described in the Bosentan REMS Program Inpatient Pharmacy Enrollment Form
  • The authorized representative can complete the enrollment forms online or download the form here and fax the form to the Bosentan REMS Program at 1-800-730-8231

3. TRAIN

TRAIN all dispensing staff on the Bosentan REMS Program

  • Prior to dispensing bosentan, the authorized representative must ensure that all staff are appropriately trained on the Bosentan REMS Program procedures and materials as defined in the Bosentan REMS Program Inpatient Pharmacy Enrollment Form
  • Any pharmacy employee may assume the role of a pharmacy staff member and associate with a certified inpatient pharmacy by accessing the Bosentan REMS Program Website to verify safe use conditions for each patient prior to dispensing bosentan

4. DOCUMENT

DOCUMENT all staff training

  • Certified pharmacies are subject to audit by Bosentan Sponsors, or a third party designated by Bosentan Sponsors to ensure that all processes and procedures are in place and are being followed for the Bosentan REMS Program.

5. VERIFY SAFE USE CONDITIONS

VERIFY SAFE USE CONDITIONS for each patient prior to dispensing bosentan

  • Dispense bosentan to patients only after calling the Bosentan REMS Program Contact Center or accessing the Bosentan REMS Program Website to verify the prescriber is certified
  • Dispense bosentan to patients only after calling the Bosentan REMS Program Contact Center, accessing the Bosentan REMS Program Website, or accessing the patient's medical record to:
    • Verify the patient is under the supervision of a prescriber who is certified
    • Verify the patient is enrolled or will be enrolled prior to discharge
  • Dispense to a patient only after he/she has been enrolled in the Bosentan REMS Program or if he/she will be enrolled prior to discharge from the healthcare facility
    • A patient who has not been enrolled by the certified prescriber will not have access to bosentan in the outpatient setting until enrollment has been completed

6. DISPENSE

DISPENSE no more than a 15-day supply of bosentan upon discharge

7. NOT TRANSFER BOSENTAN

NOT TRANSFER BOSENTAN to any pharmacy, practitioner, or any healthcare setting not certified in the Bosentan REMS Program

8. NOTIFY

NOTIFY the Bosentan REMS Program of all adverse events including those suggestive of hepatotoxicity

9. REPORT

REPORT any pregnancy and all available information during treatment with bosentan to the Bosentan REMS Program

For additional information about the Bosentan REMS Program, please call 1-866-359-2612.