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July 3, 2022

Addyi Rems Program Patient-Provider Agreement Form

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Addyi REMS Program Patient-Provider Agreement Form: What You Need to Know

The Addyi REMS (Risk Evaluation and Mitigation Strategy) program was established by the U.S. Food and Drug Administration (FDA) in 2015 to ensure that women who use Addyi (flibanserin) understand the risks and benefits of the medication. The program includes a patient-provider agreement form that must be completed before a patient can receive a prescription for Addyi.

What is Addyi?

Addyi is a medication used to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is a condition characterized by a persistent lack of interest in sexual activity that causes significant distress or interpersonal difficulty. Addyi works by affecting the levels of certain chemicals in the brain that are responsible for sexual desire.

What is the REMS program?

The REMS program is a safety program established by the FDA to manage the risks associated with certain medications. The Addyi REMS program is designed to ensure that women who use Addyi understand the risks and benefits of the medication, and that healthcare providers who prescribe the medication are educated on the appropriate use and monitoring of the medication.

What is the patient-provider agreement form?

The patient-provider agreement form is a document that must be reviewed and signed by both the patient and healthcare provider before a prescription for Addyi can be issued. The form outlines the risks and benefits of Addyi, as well as the precautions that must be taken when using the medication. It also includes a checklist of topics that must be discussed between the patient and provider before the medication is prescribed.

What is included in the patient-provider agreement form?

The patient-provider agreement form includes the following information:

– The indication for Addyi (treatment of hypoactive sexual desire disorder in premenopausal women)

– The potential risks and benefits of Addyi

– The precautions that must be taken when using Addyi (including the risk of severe hypotension and syncope when taken with alcohol)

– The need for regular monitoring by a healthcare provider

– The importance of avoiding use of Addyi in combination with certain medications and avoiding grapefruit juice while taking Addyi

– The requirement for a negative pregnancy test before starting Addyi and the need for effective contraception during treatment

– The need to discontinue Addyi if symptoms of hypotension or syncope occur

Why is the patient-provider agreement form important?

The patient-provider agreement form is an important tool to ensure that patients who use Addyi are fully informed about the risks and benefits of the medication and that healthcare providers prescribe and monitor the medication appropriately. By reviewing and signing the form, both the patient and healthcare provider acknowledge their understanding of the risks and benefits of Addyi and agree to comply with the precautions and monitoring requirements outlined in the form.

In conclusion, the Addyi REMS program patient-provider agreement form is an important component of the safety program established by the FDA to ensure the appropriate use and monitoring of Addyi. It is important for patients to discuss the risks and benefits of Addyi with their healthcare provider and to carefully review and sign the patient-provider agreement form before starting treatment with Addyi.

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