Improve your Patients' Experience
Leverage our practice support materials to educate your patients about medical abortion and what to expect, to help improve adherence and success, and to offer comfort in what may be a stressful time. GenBioPro provides these easy-to-read, patient-friendly “before and after” instructions for your use:
Patient Agreement and Medication Guide
Mifepristone is only available under an FDA-administered Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program requires that before administering medical abortion, providers review the Patient Agreement and Medication Guide with the patient and secure the patient’s signature on the Agreement. This helps to ensure that patients understand the benefits and risks associated with medical abortion, and how to seek help if needed.
Medical Abortion: Is It Right for You?
This pamphlet answers the questions typically asked about medical abortion, addressing use, safety, efficacy, and risk. It is designed to help reduce concerns and anxiety in patients seeking a medical abortion. It also helps patients understand that they are not alone, and that medical abortion is widely practiced to help millions of patients end an early pregnancy in a safe and effective way.
What to Expect Guide
This guide reviews how the two medical abortion drugs are administered, timing, possible side effects, and the follow-up clinic appointment. It also covers symptoms that require prompt attention, and what the patient should do in that event. This simple, graphic guide is a companion piece to the Patient Agreement and Medication Guide.
Become a GenBioPro Provider to Start Prescribing
To begin prescribing generic mifepristone to your patients, you must first enroll in the GenBioPro Provider Program. It’s quick and easy.
- Step 1: Download a Prescriber Agreement.
- Step 2: Ask your Medical Director to read and sign the Agreement.
- Step 3: Return the Agreement to the fax number listed on the form.
Our authorized distributor will contact you directly once your account is established and you are ready to order. That’s all it takes to become a GenBioPro provider.
Restricted Prescribing Parameters
Mifepristone is available only under an FDA-approved Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program requires that all GenBioPro providers complete and return our Prescriber Agreement, secure a signed Patient Agreement from each patient, and agree that a certified prescriber will dispense or supervise dispensing mifepristone.
Detailed Requirements for Mifepristone Providers
All providers prescribing mifepristone must:
- Review and understand the full prescribing information.
- Be able to confirm that the pregnancy is within 70 days from the start of the patient’s last menstrual period and that it is uterine, rather than ectopic.
- Walk the patient through the Patient Agreement and Medication Guide and fully explain the medical abortion process and its risks.
- Sign and secure the patient’s signature on the Patient Agreement.
- Provide the patient with a copy of the Patient Agreement and Medication Guide.
- Retain the signed Patient Agreement and record of the serial number from the prescribed package of mifepristone in the patient’s medical record.
- Provide, or direct patients to, facilities equipped for surgical intervention (including blood transfusion or resuscitation) in the event of an incomplete abortion or severe bleeding.
- Contact GenBioPro immediately to report any adverse events, designating the patient by a non-identifiable reference and the recorded serial number from the package of mifepristone.
For more information, review the FDA-Approved Mifepristone REMS Program at REMS@FDA.