How does a patient enroll in the PS-Ambrisentan REMS?
How does a pharmacy enroll in the PS-Ambrisentan REMS?
What are the PS-Ambrisentan REMS requirements for pharmacies?
What are the pharmacy types for which a pharmacy can be classified?
Outpatient PharmacyPharmacies 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:
Inpatient PharmacyAn 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)?
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:
Inpatient PharmaciesAn RDA is not required for inpatient pharmacies. Enrolled inpatient pharmacies attest that:
Does a pharmacy need to enroll in the PS-Ambrisentan REMS if already enrolled in the Letairis REMS?
Can a chain pharmacy create an account to enroll and manage multiple pharmacies?