Pharmacy

How does a patient enroll in the PS-Ambrisentan REMS?

Only female patients are required to enroll in the REMS. To enroll a female, the prescriber must complete a Patient Enrollment and Consent Form. The form may be completed and submitted online via the REMS website, through the REMS mobile apps, or by printing and faxing a completed form to the REMS Coordinating Center.

How does a pharmacy enroll in the PS-Ambrisentan REMS?

In order to dispense ambrisentan, the pharmacy must be enrolled. Pharmacies must complete an enrollment form specific to its pharmacy type (outpatient or inpatient). Additional information can be found in the Pharmacy Guide.

What are the PS-Ambrisentan REMS requirements for pharmacies?

The REMS requirements for pharmacies depend on the pharmacy type. For specific information on pharmacy requirements, please refer to the Pharmacy Guide.

What are the pharmacy types for which a pharmacy can be classified?

Outpatient Pharmacy

Pharmacies that dispense ambrisentan for outpatient use must be specially certified to enroll as one of the following pharmacy types. Each of these pharmacy types has specific requirements that must be followed to fill and dispense an ambrisentan prescription:
  • A retail pharmacy that agrees to order ambrisentan on a per patient per prescription basis (Just-in-Time (JIT) pharmacy). These pharmacies are the filling pharmacy.
  • A central fill pharmacy. Central fill pharmacies are the filling pharmacy.
  • A specialty pharmacy. Specialty pharmacies are the filling pharmacy.

Inpatient Pharmacy

An inpatient pharmacy is a pharmacy that dispenses prescriptions in an inpatient setting such as hospital, nursing home, hospice, asylum/mental facility, assisted living, prison, or rehabilitation. Inpatient pharmacies are a filling pharmacy.

How does a pharmacy validate or obtain a REMS Dispense Authorization (RDA)?

Outpatient Pharmacies

The validity of an RDA presented by the patient can be confirmed on the REMS website or by contacting the REMS Coordinating Center and providing the RDA number and the patient's date of birth from the RDA as well as the pharmacy's NPI number.

If the patient does not provide an RDA, the pharmacy must obtain an RDA from the PS-Ambrisentan REMS website (www.PSAmbrisentanREMS.com) or the REMS Coordinating Center by providing the patient's REMS ID or name, the patient's date of birth and the pharmacy's NPI number.

If an RDA cannot be validated or obtained for the patient, the pharmacy must instruct the patient to call the REMS Coordinating Center to provide the missing information. When a REMS Coordinating Center associate is contacted by the patient, the associate will determine what is preventing the issuance of an RDA.

Once an RDA is validated or obtained, the pharmacy staff must record the NDC number and days supply of the dispensed drug. This can be done through the REMS Coordinating Center or the PS-Ambrisentan REMS website. To record this information in the website, the pharmacy staff will first enter the pharmacy's NPI Number, the RDA number, and the patient's date of birth followed by the NDC number and days supply.

If monthly counseling has not been completed for the patient when the RDA is issued, the RDA will contain counseling guidelines and a message indicating that the pharmacist may:
  1. Counsel the patient using the counseling guidelines on the RDA
  2. Call the REMS Coordinating Center to receive counseling guidelines and then counsel the patient
  3. Instruct the patient to call the REMS Coordinating Center to receive counseling

Inpatient Pharmacies

An RDA is not required for inpatient pharmacies. Enrolled inpatient pharmacies attest that:
  1. Processes and procedures are in place to ensure the PS-Ambrisentan REMS requirements are met for female patients.
  2. Ambrisentan is dispensed to female patients under the supervision and care of a certified prescriber.
  3. Ambrisentan will be dispensed to a female patient after verifying the female patient's reproductive status, and that she is enrolled in the REMS or will be enrolled prior to discharge .
  4. For females of reproductive potential: Verify that pregnancy testing is complete, the patient is counseled on the risk of embryo-fetal toxicity, the need to use highly reliable contraception during treatment and for one month after stopping treatment, to get monthly pregnancy tests, and to inform the prescriber of a pregnancy immediately.
  5. No more than a 15-day temporary supply of ambrisentan will be dispensed upon discharge of a female patient.

Does a pharmacy need to enroll in the PS-Ambrisentan REMS if already enrolled in the Letairis REMS?

Yes. You must be enrolled in the PS-Ambrisentan REMS, even if already enrolled in the Letairis REMS.

Can a chain pharmacy create an account to enroll and manage multiple pharmacies?

This functionality is not supported at this time; however, a chain pharmacy corporation may provide to the REMS a list of its originating pharmacies that will be supported by its central fill pharmacies. The REMS will add these pharmacies to the “Find a Pharmacy” list of available pharmacies that are able to fill an ambrisentan prescription.