Mifepristone Tablets, 200 mg
PHARMACY AGREEMENT FORM
Pharmacies must designate an authorized representative to carry out the certification process and oversee implementation and compliance with the Mifepristone REMS Program on behalf of the pharmacy.
Healthcare settings, such as medical offices, clinics, and hospitals, where mifepristone will be dispensed by or under the supervision of a certified prescriber in the Mifepristone REMS Program do not require pharmacy certification.
By signing this form, as the Authorized Representative I certify that:
- Each location of my pharmacy that will dispense mifepristone is able to receive Prescriber Agreement Forms by email and fax.
- Each location of my pharmacy that will dispense mifepristone is able to ship mifepristone using a shipping service that provides tracking information.
- I have read and understood the Prescribing Information for mifepristone. The Prescribing Information is available by calling 1-866-718-0098, or online at www.medicalabortionpill.com; and
- Each location of my pharmacy that will dispense mifepristone will put processes and procedures in place to ensure the following requirements are completed. I also understand that if my pharmacy does not complete these requirements, the distributor may stop accepting mifepristone orders.
- Verify that the prescriber is certified in the Mifepristone REMS Program by confirming their completed Prescriber Agreement Form was received with the prescription or is on file with your pharmacy.
- Dispense mifepristone such that it is delivered to the patient within 4 calendar days of the date the pharmacy receives the prescription, except as provided in the following bullet.
- Confirm with the prescriber the appropriateness of dispensing mifepristone for patients who will receive the drug more than 4 calendar days after the date the pharmacy receives the prescription and document the prescriber's decision.
- Record in the patient's record the NDC and lot number from each package of mifepristone dispensed.
- Track and verify receipt of each shipment of mifepristone.
- Dispense mifepristone in its package as supplied by Evita Solutions LLC.
- Report any patient deaths to the prescriber, including the NDC and lot number from the package of mifepristone dispensed to the patient, and remind the prescriber of their obligation to report the deaths to Evita Solutions LLC. Notify Evita Solutions LLC that your pharmacy submitted a report of death to the prescriber, including the name and contact information for the prescriber and the NDC and lot number of the dispensed product.
- Not distribute, transfer, loan or sell mifepristone except to certified prescribers or other locations of the pharmacy.
- Maintain records of Prescriber Agreement Forms, dispensing and shipping, and all processes and procedures including compliance with those processes and procedures.
- Maintain the identity of mifepristone patients and prescribers as confidential and protected from disclosure except to the extent necessary for dispensing under this REMS or as necessary for payment and/or insurance.
- Train all relevant staff on the Mifepristone REMS Program requirements.
- Comply with audits carried out by the Mifepristone Sponsors or a third party acting on behalf of the Mifepristone Sponsors to ensure that all processes and procedures are in place and are being followed.
Any new authorized representative must complete and submit the Pharmacy Agreement Form.