Bosentan Inpatient Pharmacy Enrollment Form Operating instructions

Brand: Bosentan

Model: Inpatient Pharmacy Enrollment Form

Type: Operating instructions

Bosentan Inpatient Pharmacy Enrollment Form: Your Gateway to Safe and Compliant Bosentan Dispensing

This comprehensive form simplifies your enrollment in the Bosentan REMS program, ensuring you meet all requirements for dispensing bosentan safely and effectively. With this tool, you can:

Enroll your pharmacy in the Bosentan REMS program seamlessly.
Train staff on REMS requirements using the provided Pharmacy Guide.
Verify patient enrollment, prescriber certification, counseling completion, and necessary testing (liver function and pregnancy for females of reproductive potential).
Report adverse events, pregnancies, and maintain accurate records.

Bosentan Inpatient Pharmacy Enrollment Form: Your Gateway to Safe and Compliant Bosentan Dispensing

This comprehensive form simplifies your enrollment in the Bosentan REMS program, ensuring you meet all requirements for dispensing bosentan safely and effectively. With this tool, you can:

Enroll your pharmacy in the Bosentan REMS program seamlessly.
Train staff on REMS requirements using the provided Pharmacy Guide.
Verify patient enrollment, prescriber certification, counseling completion, and necessary testing (liver function and pregnancy for females of reproductive potential).
Report adverse events, pregnancies, and maintain accurate records.

Inpatient Pharmacy

Enrollment Form

Phone:

Fax:

1-866-359-2612

1-800-730-8231

Page 1 of 1

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:

othe patient is enrolled or will be enrolled prior to discharge,

othe patient is under the care of a certified prescriber,

ocounseling is complete,

oliver testing is complete, and

opregnancy testing is complete (for females of reproductive potential).

Before dispensing, my pharmacy must:

•Verify the patient:

ois enrolled or will be prior to discharge,

ois under the care of a certified prescriber,

ocounseling is complete,

ocompleted liver testing, and

ocompleted 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:

Reference ID: 4976585

Bosentan Inpatient Pharmacy Enrollment Form Operating instructions

Brand: Bosentan

Model: Inpatient Pharmacy Enrollment Form

Type: Operating instructions

Bosentan Inpatient Pharmacy Enrollment Form: Your Gateway to Safe and Compliant Bosentan Dispensing

This comprehensive form simplifies your enrollment in the Bosentan REMS program, ensuring you meet all requirements for dispensing bosentan safely and effectively. With this tool, you can:

Enroll your pharmacy in the Bosentan REMS program seamlessly.
Train staff on REMS requirements using the provided Pharmacy Guide.
Verify patient enrollment, prescriber certification, counseling completion, and necessary testing (liver function and pregnancy for females of reproductive potential).
Report adverse events, pregnancies, and maintain accurate records.

Download PDF

report

Bosentan Inpatient Pharmacy Enrollment Form Operating instructions

Bosentan Inpatient Pharmacy Enrollment Form Operating instructions

Related papers

Other documents