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Procedures for Abortion

There are two different types of abortion procedures: medical and surgical. A medical abortion is performed by taking a series of two medications. Mifepristone first and after 48 hours misoprostol apart from one another, to end an early pregnancy.

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Abortion is common, and people have abortions for many different reasons.  Only you know what’s best for you, but good information and support can help you make the decision that’s best for your own health and well-being. You can get abortion pills from us in Ohio at best price.

What is a Medication Abortion?

The most common medication abortion regimen in the United States involves the use of two different medications: mifepristone and misoprostol. Mifepristone, sold under the brand name Mifeprex and also known as the abortion pill, RU-486. It blocks progesterone, a hormone essential to the development of a pregnancy, and thereby prevents an existing pregnancy from progressing.

Misoprostol, taken 24-48 hours after mifepristone, works to empty the uterus by causing cramping and bleeding, similar to an early miscarriage. A follow-up visit is typically scheduled a week or two later, to confirm that the pregnancy was terminated via ultrasound or blood test. Medication abortion is a safe and highly effective method of pregnancy termination if the pills are administered at 9 weeks’ ge­­station or less, the pregnancy is terminated successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).

FDA Protocol

The FDA first approved Mifeprex in 2000, and in 2016, the FDA approved a new evidence-based regimen and drug label, which guides current clinical practice. This regimen approves use of medical abortions for up to 70 days (10 weeks) of pregnancy (Table 1). Until 2019, mifepristone was only sold under the brand name Mifeprex, manufactured by Danco Laboratories. In 2019, the FDA approved GenBioPro, Inc.’s application for generic mifepristone. Mifeprex alternate is available in our store.

Table 1: FDA Mifepristone and Misoprostol Regimen
Max. gestational ageUp to 70 days LMP* (10 weeks)
Mifepristone dosage200mg (one pill), taken orally
Mifepristone administrationCan be dispensed via mail or by pharmacy; Dispensed in office in states that ban telehealth for medication abortion.
Misoprostol dosage800µg (4 pills), taken buccally (placed in cheek) or vaginally
Misoprostol timing24-48 hours after mifepristone buccally, or 6-72 hours after mifepristone vaginally
Misoprostol administrationTaken at home
Follow-up visit7-14 days after mifepristone, no location specified
Prescriber requirementsBy or under the supervision of a prescriber that has been certified by the manufacturer
Note: *LMP – Last Menstrual Period
Source: FDA, Mifeprex (mifepristone) Information, February 2018.
Mifepristone and Misoprostol Table

Risk Evaluation and Mitigation Strategies (REMS)

In 2011, the FDA added a Risk Evaluation and Mitigation Strategy (REMS) to the dispensing requirements for mifepristone permitting only medical providers who had obtained  certification from the manufacturer to prescribe and directly dispense the drug. This requirement not only limited the number of clinicians able to prescribe medication abortions, but also necessitated an in-person visit to a health care setting and meant patients could not obtain the medication from a retail pharmacy or by mail.

In October 2017, the American Civil Liberties Union (ACLU) filed a lawsuit, on behalf of a group of providers, against the FDA challenging the REMS requirements for mifepristone. These plaintiffs cite the low rate of complications associated with medical abortions and assert that other drugs with similar or more serious risks do not have REMS restrictions, and are unduly burdensome on patients trying to access the drug, particularly patients in rural or medically underserves areas. The case is still pending in front of the District Court of Hawaii. During the pandemic, ACOG and other provider groups filed a lawsuit challenging the REMS requirement that mifepristone be dispensed in person in response to the importance of having an alternative to the in-person requirement because of the public health emergency.

On May 7th, 2021, in response to the ACLU lawsuit, the FDA announced in a court filing that a review of the REMS was underway. On December 16, 2021, the FDA removed the in-person dispensing requirement for mifepristone and expanded the distribution to certified pharmacies in addition to certified clinicians. This change allows for distribution of medication abortion by mail in states that do not restrict telehealth for medication abortion. This change to the dispensing requirement came after an extensive scientific review of the safety of medication abortion as prompted by the ACLU and ACOG lawsuits. Despite the change to the in-person requirement, prescribers are still required to be certified by the manufacturers. In April of 2022, Danco Laboratories and GenBioPro (the two manufacturers of mifepristone) are expected to submit proposed protocols to the FDA to describe how they certify pharmacies, after which the FDA has 180 days to review or modify the submissions. Pharmacies may be able to dispense mifepristone by late 2022. Box 2 shows the change in REMS from 2011 to 2021.

Kathleen

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