Bosentan Outpatient Pharmacy Enrollment Form Instructions

Bosentan Outpatient 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 Outpatient 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.

Before dispensing, my pharmacy must:
For all patients:

• Obtain authorization to dispense each prescription by contacting the Bosentan REMS to verify:
  • the patient is enrolled,
  • the prescriber is certified,
  • the pharmacy is certified,
  • if counseling is complete,
  • liver testing is complete,
  • the reproductive status has not changed for female patients, and
  • the pregnancy test is completed for females of reproductive potential or the prescriber authorizes the refill.
• Dispense no more than a 30 days’ supply.

For patients without documented testing:

• Communicate with the patient or prescriber to confirm testing.
• Document and submit the confirmation of testing using the Bosentan REMS Website or by calling the Contact Center.

For all patients without documented counseling on hepatotoxicity:

• Counsel the patient on the risk of hepatotoxicity.
• Document and submit the confirmation of counseling using the Bosentan REMS Website or by calling the Contact Center.

For females of reproductive potential and pre-pubertal females without documented counseling on embryo-fetal toxicity:

• Counsel the patient on the risk of embryo-fetal toxicity.
• Document and submit the confirmation of counseling using the Bosentan REMS Website or by calling the Contact Center.

At all times my pharmacy must:

• 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
  • Dispensing,
  • Training, and
  • 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.
• Have the new authorized representative certify in the Bosentan REMS by completing the Outpatient Pharmacy Enrollment Form if the authorized representative changes.

Pharmacy Information (All fields required)
Pharmacy Name:
Pharmacy 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:

References

• Bosentan REMS

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