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Misoprostol-Only Medication Abortion Regimen

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Political Climate

After the U.S. Supreme Court’s decision to eliminate the constitutional protections for abortion in Dobbs v. Jackson Women’s Health Organization in June 2022, access to mifepristone and abortion services in general are being threatened across the country.

An ongoing anti-abortion lawsuit in Texas seeks to reverse mifepristone’s FDA approval and remove it from the market, even in states where abortion is legal.

This won’t shut down medication abortion altogether, but it will limit treatment options. In the unfortunate case that mifepristone is taken off the market, we need to be prepared to use other regimens such as misoprostol-only.

 

Background

Misoprostol can safely be used alone for medication abortion if mifepristone is not available. It is used off-label for abortion because it is effective at inducing uterine contractions and cervical ripening.

Evidence from a range of sources including randomized control trials, a meta-analysis, a retrospective review and others, shows that misoprostol-only successfully terminates around 80-100% of pregnancies without needing procedural intervention.1 

 

Safety

Side effects for the misoprostol-only regimen are similar to the combined mifepristone and misoprostol regimen, however they may last longer due to the multiple doses.

Beyond vaginal bleeding, other common side effects of misoprostol include nausea, abdominal pain and cramping, diarrhea, and fever/chills. Major complications requiring hospital admission, blood transfusions, or surgery are rare and occur in <1% of cases.1 Patients should seek medical attention if they experience heavy bleeding that soaks 2 full-size pads per hour for 2 consecutive hours, a persistent fever over 100°F that lasts more than 4 hours, severe abdominal pain that is unresponsive to pain medications, or general malaise that lasts over 24 hours after the last misoprostol dose.

It’s critical to acknowledge that self-managed abortions occur and that they may increase, especially in states with severe abortion bans. Available data on self-managed abortions suggest a low prevalence of serious adverse outcomes.2

Pharmacists have been publicly deemed as some of the most trusted healthcare professionals, and it’s important to think about how we can be a safe resource for patients who do seek support for adverse events while protecting them and ourselves from legal repercussions.

 

Sample Protocol

The following sample protocol is endorsed by the Society of Family Planning.3 Providers may use it for guidance when screening patients in-person or through telehealth. Of note, the buccal route of administration is not included in this protocol, but is commonly used as well.

 

Eligibility Criteria 

  • Pregnancy confirmed by urine, serum test, or ultrasound 
  • Gestational age ≤ 12 weeks 
  • None of the following risk factors or symptoms of ectopic pregnancy:
    • Vaginal bleeding or spotting within the past week
    • Pelvic pain within the last week 
    • Prior ectopic pregnancy or tubal surgery
    • IUD currently in uterus or at time of conception
  • No history of hemorrhagic disorder or concurrent anticoagulant therapy
  • No history of allergy to misoprostol or other prostaglandin 
  • Patient has made an informed decision to use misoprostol-only for abortion

Treatment

  • Misoprostol 800 mcg sublingually or vaginally every 3 hours for at least 3-4 doses per clinician judgment
    • Sublingual route: put all 4 pills under the tongue and leave them there for 30 minutes, then swallow what’s left with water
    • Vaginal route: wash hands, lie down, and use finger to insert 4 pills as high up into the vagina as able to and stay lying down for 30 minutes. Moistening each tablet with a few drops of water before insertion may improve effectiveness
  • Analgesics, antipyretic, antiemetics, antidiarrheals as indicated or needed per the clinician

Follow-up

  • Confirm abortion completion by one of the following:
    • Urine pregnancy test 4 weeks after misoprostol use
      • If positive, evaluate with ultrasound or serum HCG tests
    • Ultrasound or pelvic examination 1-2 weeks after misoprostol use 
    • Serial serum HCG testing
      • First test on the day of initial misoprostol ingestion
      • Second test 1-2 weeks later

 

References

  1. Society of Family Planning. (2023). Misoprostol Only is Safe and Effective [fact sheet]. Retrieved from https://societyfp.org/wp-content/uploads/2023/02/SFP_ScienceSays_misoprostol.pdf
  2. Aiken ARA, Romanova EP, Morber JR, Gomperts R. Safety and effectiveness of self-managed medication abortion provided using online telemedicine in the United States: A population based study. Lancet Reg Health Am. 2022;10:100200. doi:10.1016/j.lana.2022.100200 
  3. Raymond EG, Mark A, Grossman D, et al. Medication abortion with misoprostol-only: A sample protocol [published online ahead of print, 2023 Feb 26]. Contraception. 2023;109998. doi:10.1016/j.contraception.2023.109998


michelle (2)About the Author

Michelle Chung, Pharm.D Candidate, is a 4th-year student pharmacist in the Class of 2023 at the University of Washington School of Pharmacy. Michelle completed an elective APPE rotation with Birth Control Pharmacist.

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