Medication Abortion Care Resources

What the Pharmacy Community Should Know

FDA Releases Updated REMS Requirements for Mifepristone

On January 3rd, 2023, the FDA released updated Risk Evaluation and Mitigation Strategies (REMS) for Mifepristone, opening a pathway for pharmacies in all settings, including brick-and-mortar retail pharmacies, to become certified to dispense Mifepristone.

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What is Medication Abortion Care?

Medication abortion care is a safe, effective non-invasive abortion option that is approved for use up to 10 weeks in pregnancy. It involves the use of two FDA-approved drugs:

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Mifepristone

A pill that inhibits the physiological action of progesterone, a hormone needed to sustain pregnancy.

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Misoprostol

Pills taken within 24-48 hours of mifepristone to complete the abortion process.

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The Pharmacy Community Should Know That...

Medication abortion care is FDA-approved, safe, and effective.

  • It has been in use for 20+ years

  • More than 4.9 million people have safely used medication abortion since FDA approved it in 2000

  • It is 99.6% effective within first 10 weeks gestation

  • Serious adverse events occur in fewer than 0.5% of medication abortions

Mifepristone and misoprostol can also be prescribed to manage early miscarriage.

Increase in Medication Abortion Care

Factors contributing to increase:

  • Evidence shows trained non-physician health care professionals can safely provide medication abortion care
  • COVID-19 pandemic and telemedicine expansion
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As of 2020, medication abortions account for the majority of all US abortions

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Source: Guttmacher Institute

Impact

Telehealth has shortened wait times and increased access for underserved, minority, and rural communities.

Figpie

97%

patient satisfaction with medication abortion care

Federal Regulation of Medication Abortion

  • Risk Evaluation and Mitigation Strategies (REMS) for mifepristone
  • REMS required that medication abortion be:
  • Ordered, prescribed and dispensed by/under the supervision of a certified prescriber
  • Certified prescriber must complete a Prescriber Agreement Form and provide
  • Medication Guide to patient
  • Certified prescribers will share their Prescriber Agreement Form with individual certified pharmacies
  • Patient must complete a Patient Agreement Form which will be shared with certified pharmacies.
  • Certified pharmacies will be responsible for maintaining and protecting Prescriber Agreement Forms, timely dispensation, and further consultation with the patient.

What is a Certified Prescriber?

Healthcare providers who meet certain qualifications to prescribe medication abortion may become certified. Prescribers must be able to:

  • Date pregnancies accurately
  • Diagnose ectopic pregnancies
  • Ensure patients have access to back up or emergency care if needed
  • Provide the Patient Agreement Form
  • Complete a Prescriber Agreement Form and share it with any certified pharmacy where the prescriber sends a mifepristone prescription

These simple steps are basic for most providers.

The biggest historical hurdle has been in-clinic distribution.

Changes to REMS for Medication Abortion Care

  • FDA has periodically updated REMS for medication abortion based on evidence-based protocols
  • The pandemic prompted FDA to waive the in-person dispensing requirement during the PHE
  • In December 2021, FDA permanently removed the in-person dispensing requirement, finding it scientifically unnecessary
  • The 2021 REMS change opened the door for retail distribution of medication abortion drugs in addition to the mail-order option.
  • Medication abortion through mail-order pharmacies has proven safe and effective, satisfactory to patients, and feasible
  • FDA’s January 2023 REMS finalization sets clear standards that allow certified pharmacies in all health care settings to dispense mifepristone.

New FDA Certification Requirements for Pharmacies

In December 2021, FDA announced that the mifepristone REMS would be updated to maintain mail-order and online practice, and expand into brick-and-mortar pharmacy practice. On January 3, 2023, the FDA released a REMS update and certification requirement for prescribers and pharmacies. As of January 3, 2023, certified prescribers can send prescriptions to certified pharmacies (brick-and-mortar, online, and mail-order) to dispense.

Some States are Attempting to Override FDA Through Legislation

State are passing laws to override FDA’s scientific authority and add new restrictions on medication abortion, including:

  • Banning use of FDA approved medication
  • Banning care after 6, 7, 8 weeks of pregnancy
  • Prohibiting mail-order dispensing of mifepristone and misoprostol
  • Banning telehealth for medication abortion care
  • Limiting to physician-only prescribing
  • Mandating in-person visits

Other state restrictions impose additional burdens, such as:

  • Adding waiting periods to delay care
  • Creating state board of pharmacy certification requirements, which don’t exist for any other type of care