Bosentan Inpatient Pharmacy Enrollment Form Instructions
- October 27, 2023
- 1-800-Innovations
Table of Contents
Bosentan Inpatient Pharmacy Enrollment Form
Inpatient Pharmacy Enrollment Form
Instructions
For immediate enrollment, please go to www.BosentanREMSProgram.com. Scan the Quick Response (QR) code to complete the form online.
To submit this form via fax or mail, please complete all required fields below and fax to 1-800-730-8231 or mail to the Bosentan REMS, 200 Pinecrest Plaza Morgantown, WV 26505. Upon completion of these steps, the Bosentan REMS will notify you of successful certification. If you have questions, require additional information, or need additional copies of Bosentan REMS documents, visit www.BosentanREMSProgram.com, or call the Bosentan REMS at 1-866-359-2612.
Authorized Representative Responsibilities
I am the authorized representative designated by my pharmacy to oversee
implementation of and compliance with the Bosentan REMS. I attest to
understanding the Bosentan REMS requirements, and accept responsibility to:
As the Authorized Pharmacy Representative, I must:
- Review the Pharmacy Guide.
- Enroll in the Bosentan REMS by completing the Inpatient Pharmacy Enrollment Form and submitting it to the Bosentan REMS.
- Train all relevant staff involved in dispensing bosentan on the Bosentan REMS requirements using the Pharmacy Guide.
- Establish processes and procedures to verify:
- The patient is enrolled or will be enrolled prior to discharge,
- The patient is under the care of a certified prescriber,
- Counseling is complete,
- Liver testing is complete, and
- Pregnancy testing is complete (for females of reproductive potential).
Before dispensing, my pharmacy must:
- Verify the patient:
- Is enrolled or will be prior to discharge,
- Is under the care of a certified prescriber,
- counseling is complete,
- completed liver testing, and
- completed pregnancy testing (for females of reproductive potential).
At all times, my pharmacy must:
- Have the new authorized representative certify in the Bosentan REMS by completing the Inpatient Pharmacy Enrollment Form if the authorized representative changes.
- Report adverse events suggestive of hepatotoxicity to the Bosentan REMS.
- Report pregnancies to the Bosentan REMS.
- Not distribute, transfer, loan, or sell bosentan, except to certified dispensers.
- Maintain records of training.
- Maintain records that all processes and procedures are in place and are being followed.
- Comply with audits carried out by the manufacturers or a third party acting on behalf of the manufacturers to ensure that all processes and procedures are in place and are being followed.
At discharge, my pharmacy must:
- Dispense no more than a 15 days’ supply.
Pharmacy Information (All fields required)
Institution or Healthcare Setting Name:
Provide one of the following identifiers: NCPDP: NPI: DEA:
Address: City:
State: Zip Code:
Phone: Fax:
Authorized Representative Information (All fields required)
First Name: Last Name:
Credentials (select one): RPh PharmD BCPS Other
Office Phone: Fax: Email:
Preferred Method of Contact (select one): Fax Email
Authorized Representative Signature
By signing below, you signify your understanding of the risks of bosentan
treatment, your obligations as a pharmacy certified in the Bosentan REMS
as outlined above, and you agree to oversee the implementation of and
compliance with the Bosentan REMS requirements for this pharmacy.
Signature: Date: