Bosentan Outpatient Pharmacy Enrollment Form Operating instructions

Brand
Bosentan
Model
Outpatient Pharmacy Enrollment Form
Type
Operating instructions

Bosentan Outpatient Pharmacy Enrollment Form: A Comprehensive Guide for Pharmacies

The Bosentan Outpatient Pharmacy Enrollment Form is an essential tool for pharmacies seeking to dispense bosentan, a medication used to treat pulmonary arterial hypertension. This form outlines the requirements and responsibilities of authorized pharmacy representatives, ensuring patient safety and compliance with the Bosentan REMS program.

To enroll, pharmacies must complete the form and submit it via fax or mail. Upon successful enrollment, the pharmacy will receive notification of certification. The authorized representative must review the Pharmacy Guide, train relevant staff, and obtain authorization for each prescription.

Bosentan Outpatient Pharmacy Enrollment Form: A Comprehensive Guide for Pharmacies

The Bosentan Outpatient Pharmacy Enrollment Form is an essential tool for pharmacies seeking to dispense bosentan, a medication used to treat pulmonary arterial hypertension. This form outlines the requirements and responsibilities of authorized pharmacy representatives, ensuring patient safety and compliance with the Bosentan REMS program.

To enroll, pharmacies must complete the form and submit it via fax or mail. Upon successful enrollment, the pharmacy will receive notification of certification. The authorized representative must review the Pharmacy Guide, train relevant staff, and obtain authorization for each prescription.

Outpatient Pharmacy
Enrollment Form
Phone:
Fax:
1-866-359-
2612
1-800-730-
8231
Page 1 of 2
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:
othe patient is enrolled,
othe prescriber is certified,
othe pharmacy is certified,
oif counseling is complete,
oliver testing is complete,
othe reproductive status has not changed for female patients, and
othe 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
odispensing,
otraining, and
othat 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.
Continued on the following page.
Pharmacy Information (All fields required)
Pharmacy Name:
Pharmacy Identifiers: NCPDP: NPI: DEA:
Address: City:
State: Zip Code:
Phone:
Fax:
Reference ID: 4976585
Outpatient Pharmacy
Enrollment Form
Phone:
Fax:
1-866-359-
2612
1-800-730-
8231
Page 2 of 2
Authorized Representative Information (All fields required)
First Name:
Last Name:
Credentials (select one):
RPh
PharmD
BCPS
Other
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:
Reference ID: 4976585
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Bosentan Outpatient Pharmacy Enrollment Form Operating instructions

Brand
Bosentan
Model
Outpatient Pharmacy Enrollment Form
Type
Operating instructions

Bosentan Outpatient Pharmacy Enrollment Form: A Comprehensive Guide for Pharmacies

The Bosentan Outpatient Pharmacy Enrollment Form is an essential tool for pharmacies seeking to dispense bosentan, a medication used to treat pulmonary arterial hypertension. This form outlines the requirements and responsibilities of authorized pharmacy representatives, ensuring patient safety and compliance with the Bosentan REMS program.

To enroll, pharmacies must complete the form and submit it via fax or mail. Upon successful enrollment, the pharmacy will receive notification of certification. The authorized representative must review the Pharmacy Guide, train relevant staff, and obtain authorization for each prescription.

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