Edit, Download, and Sign the Ambrisentan REMS Patient Enrollment Consent Form
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How do I fill this out?
Filling out this form requires collecting specific patient information and ensuring accurate completion. Start by providing all required personal details. Follow the instructions carefully for each section to ensure compliance and safe treatment initiation.
How to fill out the Ambrisentan REMS Patient Enrollment Consent Form?
1
Collect personal information including name and contact details.
2
Review the Guide for Female Patients thoroughly.
3
Complete the Patient Enrollment Form with the prescriber.
4
Ensure to submit the form either online or via fax.
5
Consult your prescriber regarding counseling requirements.
Who needs the Ambrisentan REMS Patient Enrollment Consent Form?
1
Patients diagnosed with pulmonary arterial hypertension who require treatment with ambrisentan.
2
Prescribers needing to document and enroll patients in the REMS program.
3
Pharmacists responsible for ensuring the REMS requirements are met before dispensing ambrisentan.
4
Parents or guardians of pre-pubertal female patients who need to enroll their children.
5
Healthcare providers involved in monitoring and counseling patients about the drugs' use.
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What are the instructions for submitting this form?
To submit the Ambrisentan REMS Patient Enrollment Form, fax it to 1-866-750-9802 or submit it online at www.ambrisentanrems.us.com. Ensure that all fields are filled out accurately to avoid delays in processing. For assistance with the form, contact customer service at 1-888-417-3172 for further guidance.
What are the important dates for this form in 2024 and 2025?
Important dates for submitting the Ambrisentan REMS Patient Enrollment Form include: initial enrollment dates in 2024 and 2025, monthly check-in requirements along the treatment period, and deadlines for periodic updates. These ensure compliance with the REMS requirements and patient safety throughout the treatment process.
What is the purpose of this form?
The purpose of this form is to enroll patients in the Ambrisentan Risk Evaluation and Mitigation Strategy (REMS). It is vital for maintaining patient safety by ensuring females can safely receive treatment while managing risks associated with ambrisentan use. This form also provides the necessary data for prescribers to monitor patients' reproductive status and ensure they follow contraceptive guidelines.
Tell me about this form and its components and fields line-by-line.
- 1. Patient Information: Includes personal details like name, address, and contact information.
- 2. Female Patient Agreement: Outlines agreement terms for female patients regarding pregnancy tests and contraception.
- 3. Prescriber Information: Captures the prescriber's credentials and contact details for compliance tracking.
- 4. Statement of Medical Necessity: Requests diagnosis verification and categorization under pulmonary hypertension.
- 5. Prescriber Authorization: Confirms the prescriber has provided necessary counseling and recorded reproductive potential.
What happens if I fail to submit this form?
Failure to submit this form could result in delays in treatment initiation. Patients may not receive the necessary medications without proper enrollment in the REMS. It also poses risks regarding potential pregnancy while on treatment, which the REMS is designed to safeguard against.
- Delay in Treatment: Patients may face delays in starting ambrisentan therapy due to incomplete enrollment.
- Unsafe Medication Dispensing: Pharmacies may refuse to dispense medication if the REMS procedure is not followed.
- Increased Risks During Treatment: Failure to comply could lead to increased risks of serious birth defects.
How do I know when to use this form?
- 1. Initial Enrollment: Use this form to begin enrollment in the REMS program upon prescription.
- 2. Periodic Updates: Must be used for updating any changes in reproductive status during treatment.
- 3. Consulting with Prescribers: Useful when discussing treatment options and necessary precautions with healthcare providers.
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