Tag: misoprostol

Misoprostol-Only Medication Abortion Regimen

Untitled design

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.

Medication Abortion Curriculum: A Pharmacy Student Perspective

The topics of reproductive health and particularly abortion remains stigmatized in today’s society despite 1 in 4 women having an abortion in their lifetime. Pharmacy school curriculums across the nation reflect this predicament, since abortion is omitted in the standard curriculum of many, if not all, pharmacy schools. Which brings up a question of how knowledgeable are student pharmacists, future medication specialists, with this subject?

Medication Abortion Curriculum was developed by the expert pharmacy educators at Birth Control Pharmacist in an attempt to better familiarize pharmacy students with the topic of medication abortion. This open access curriculum is a PowerPoint deck that is intended to be added or incorporated within a standard, larger lecture such as contraception. The slides provide the basics on medication abortion and prepare pharmacy students to dispense medications and counsel patients appropriately.

Medication abortion with a regimen of mifepristone and misoprostol has been shown to be safe and effective for decades, and is becoming increasingly utilized and acceptable to women across the world.1 Despite the growing use of these medications to induce termination of early pregnancy, the U.S. pharmacist involvement in abortion care is currently limited due to FDA imposed restrictions on how mifepristone can be distributed and dispensed.2 However, in some countries both medications are allowed to be dispensed by pharmacies rather than being limited to clinics and doctor’s offices, improving accessibility for people in need.3,4 Current research has shown great benefits of expanding the types of clinicians providing services, which may eventually lead to FDA lifting unnecessary restrictions to increase access to medication abortion through pharmacies.5

Diversification of skills and areas of expertise is necessary for any future pharmacists who want to stay relevant in tomorrow’s healthcare. Pharmacists need to be prepared to dispense and counsel on misoprostol now and may be able to offer additional patient-centered care in the future. For these reasons, pharmacists should be capable of providing patients with sufficient information, education, and safe and convenient care.

If you’re a pharmacy educator or a student who wants to advocate for medication abortion to be included in your school’s curriculum, check out the slide deck on the Resources page under Pharmacist Education and Training. 

Medication Abortion Curriculum Open Access for Pharmacy Educators

References

  1. Beaman J, Prifti C, Schwarz EB, et al. Medication to Manage Abortion and Miscarriage. J Gen Intern Med. 2020;35(8):2398-2405. doi:10.1007/s11606-020-05836-9.
  2. Raifman S, Orlando M, Rafie S, et al. Medication abortion: Potential for improved patient access through pharmacies. J Am Pharm Assoc (2003). 2018;58(4):377-381.doi:10.1016/j.japh.2018.04.011.
  3. Tamang A, Puri M, Masud S, et al. Medical abortion can be provided safely and effectively
    by pharmacy workers trained within a harm reduction framework: Nepal. Contraception. 2018;97(2):137-143. doi:10.1016/j.contraception.2017.09.004.
  4. Rogers C, Sapkota S, Paudel R, et al. Medical abortion in Nepal: a qualitative study on women’s experiences at safe abortion services and pharmacies. Reprod Health. 2019;16(1):105. doi:10.1186/s12978-019-0755-0.
  5. Weaver G, Schiavon R, Collado ME, et al. Misoprostol knowledge and distribution in Mexico City after the change in abortion law: a survey of pharmacy staff. BMJ Sex Reprod Health. 2019;46(1):46-50. doi:10.1136/bmjsrh-2019-200394.


About the AuthorEugenia

Eugenia A. Haire, PharmD Candidate is a pharmacy student in the Class of 2021 at the Shenandoah University Bernard J. Dunn School of Pharmacy. Eugenia completed an elective APPE rotation with Birth Control Pharmacist.