Misoprostol-Only Medication Abortion Regimen – Birth Control Pharmacist

Political Climate

After the US Supreme Court’s decision to remove constitutional protections for abortion in Dobbs v. Jackson Women’s Health Organization in June 2022access to mifepristone and abortion services in general is at risk nationwide.

A constant case against abortion in Texas seeks to overturn the FDA’s approval of mifepristone and take it off the market, even in states where abortion is legal.

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

Background

Misoprostol can be safely used alone for medical abortion if mifepristone is not available. It is used off-label for abortion because it is effective in 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 in approximately 80-100% of pregnancies without the need for 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 multiple doses.

Beyond vaginal bleeding, other common side effects of misoprostol include nausea, abdominal pain and cramping, diarrhea, and fever/shivering. Major complications requiring hospital admission, blood transfusion, or surgery are rare and occur in <1% of cases.¹ Patients should seek medical attention if they experience profuse bleeding that soaks 2 full-size pads per hour for 2 consecutive hours, persistent fever greater than 100°F lasting more than 4 hours, severe abdominal pain that does not respond to pain medications, or general malaise lasting more than 24 hours after the last dose of misoprostol.

It is very important to recognize that self-managed abortions do occur and that they may be on the rise, especially in states with strong abortion bans. Available data on self-managed abortions suggest a low prevalence of serious adverse outcomes.²

Pharmacists are widely regarded as some of the most trusted healthcare professionals, and it is important to consider how we can be a safe resource for patients seeking support for adverse events while protecting them and ourselves from legal effect.

Sample Protocol

The following sample protocol is endorsed by the Society of Family Planning.³ Providers can use it for guidance when examining patients in person or via telehealth. Note, the buccal route of administration is not included in this protocol, but is also commonly used.

Eligibility Criteria

• Pregnancy is 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 past week
  • Previous ectopic pregnancy or tubal surgery
  • IUD currently in the uterus or at the time of conception
• There was no history of hemorrhagic disorder or concomitant anticoagulant therapy
• There was no history of allergy to misoprostol or other prostaglandins
• The patient made an informed decision to use misoprostol-only for the 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 the rest with water
  • The vaginal route: wash your hands, lie down, and use a finger to insert 4 pills as high as you can and stay lying down for 30 minutes. Wetting each pill with a few drops of water before ingestion may improve
• Analgesics, antipyretic, antiemetics, antidiarrheal as indicated or needed by clinician

Monitoring

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

Sources

1. Family Planning Society. (2023). Only Misoprostol is Safe and Effective [fact sheet]. Obtained 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 using misoprostol-only: A sample protocol [published online ahead of print, 2023 Feb 26]. Contraception. 2023;109998. doi:10.1016/j.contraception.2023.109998

About the Author

Michelle ChungPharm.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 the Birth Control Pharmacist.