Espresso: Update to the Mifespristone REMS Requirements

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Reading: ACOG Practice Advisory: Updated Mifepristone REMS Requirements

Background 

  • What is mifepristone? 

    • As you probably know, mife is used in combination with misoprostol as part of medication abortion 

    • This method is safe, effective, and FDA-approved 

    • Can also be used for early pregnancy loss 

    • Check out our medication abortion and telehealth abortion episodes! 

    • However: 

      • Starting in 2011, the FDA implemented the Mifepristone REMS (risk evaluation and mitigation strategy) Program placed several restrictions on mifepristone distribution 

      • There needed to be an in-person dispensing requirement 

        • Needed to be dispensed in a clinic, medical office, or hospital by or under direct supervision of a certified clinician 

        • So patients could not get the mifepristone in a retail pharmacy or by mail 

    • ACOG has long advocated for removal of this restriction 

      • Doesn’t make care safer 

      • Not based on medical evidence 

      • Creates barriers to clinician and patient access to medication abortion and medical management of early pregnancy loss 

      • Disproportionately burdens communities already facing structural barriers to care 

Why are we making this episode? 

  • Timeline 

    • During COVID-19, with advocacy, the FDA halted enforcement of the REMS in-person dispensing requirement due to public health emergency

      • This allowed telehealth provision of mifepristone and also by mail in some states  

    • December 2021 - FDA completed a review of the Mifepristone REMS Program and determined that modifications were warranted to reflect long-standing safety data, improve patient access, and reduce burden on health care delivery 

    • January 3, 2023 - Drug manufacturer’s submission of updated prescribing information, etc. and was approved by FDA 

  • Updates 

    • Permanent removal of in-person dispensing requirement 

      • So in addition to clinics, medical offices, hospital: certified pharmacies can now dispense mifepristone to patients with prescription from certified prescriber 

      • Mifepristone can be dispensed in-person or by mail 

    • Addition of a pharmacy certification requirement 

      • Retail pharmacies that meet certain requirements and complete a Pharmacy Agreement Form can now dispense mifepristone to patients to patients who have a prescription from a certified prescriber 

    • Find the documents can be found on the FDA website.

What does this mean for us and for our patients? 

  • Increase access to medication abortion 

    • Maybe – can still be dependent on state-specific laws and ability and willingness of retail pharmacies to achieve REMS certification 

      • Some states restrict abortion

      • Some states restrict telehealth access, may still require in-person dispensing of mifepristone, and regulation of medications by mail 

    • So… the REMS requirements still remain as a medically unnecessary barrier to obtaining this medication