ATT D11 Clinical Guidance Medication Abortion mife-miso.pdf

Last updated: March 1, 2023

Medication Abortion Clinical Guidance for VA Clinicians Treating Veterans with

Mifepristone and Misoprostol

VA’s medical benefits package excludes abortions except when: 1) the life or health of the pregnant Veteran would be endangered if the pregnancy were carried to term; or 2) the pregnancy is the result of an act of rape or incest. Care in the medical benefits package will be provided to individuals only if it is determined by appropriate health care professionals that the care is needed to promote, preserve, or restore the health of the individual and is in accord with generally accepted standards of medical practice.

(i) Promote health. Care is deemed to promote health if the care will enhance the quality of life or daily functional level of the veteran, identify a predisposition for development of a condition or early onset of disease which can be partly or totally ameliorated by monitoring or early diagnosis and treatment, and prevent future disease.

(ii) Preserve health. Care is deemed to preserve health if the care will maintain the current quality of life or daily functional level of the veteran, prevent the progression of disease, cure disease, or extend life span.

(iii) Restore health. Care is deemed to restore health if the care will restore the quality of life or daily functional level that has been lost due to illness or injury.

The purpose of this document is to provide clinical guidance to VA clinicians who are providing medication abortions using mifepristone and misoprostol to pregnant Veterans.

SCOPE/APPLICABILITY:

This guidance is for provision of medication abortion using mifepristone and misoprostol up to 70 days (10 weeks) gestation.

PRESCRIBING MIFEPRISTONE:

Clinicians must meet FDA requirements for the provision of mifepristone. The clinician must complete and submit a Provider Agreement Form as required by FDA’s Risk Evaluation and Mitigation Strategy (REMS) for mifepristone to the designated office.

The Provider Agreement Form only needs to be filled out once per clinician for each site of care. However, the form must be sent to the local pharmacy staff EVERY TIME A

PRESCRIPTION IS WRITTEN.

CLINICIANS’ RESPONSIBILITIES:

Prior to provision of medication abortion using mifepristone and misoprostol, it is the clinician’s responsibility to:

1. Review eligibility criteria per VA regulations.

Office of Women’s Health VHACOReproductiveHealthTeam@va.gov

Last updated: March 1, 2023

2. Obtain the patient’s prior and voluntary informed consent to use of a medication abortion, to include the required informed consent discussion elements, e.g., including complete abortion success rates, risks of continuing the pregnancy, risks of adverse outcomes associated with a medication abortion, benefits, and alternatives.

a. ACOG Patient-Facing FAQs Induced Abortion

3. Obtain a completed and signed Mifepristone Patient Agreement Form from the patient as required by FDA’s Risk Evaluation and Mitigation Strategies (REMS) for mifepristone. The signed form should be scanned into the patient’s electronic health record. Note: the form does not need to be scanned prior to dispensing medication.

4. Provide the patient with a copy of the Mifepristone Medication Guide as required by FDA’s REMS for mifepristone

5. Counsel the patient about what to expect with medication abortion, including side effects, medications to manage side effects, and warning signs.

6. Assess the patient’s need for clinical support services including social work, behavioral/mental health, pastoral or spiritual care. Place any necessary consults or referrals.

7. Assess the patient’s need for/desire for contraception (consistent with the contraceptive criteria information set forth in the clinical criteria below) following the medication abortion and offer it to the patient, who can accept or reject it.

8. Schedule follow-up either in person or via telehealth. See clinical criteria below.

9. Complete timely all required documentation/reporting requirements and enter into the patient’s medical record.

EVALUATION AND ANCILLARY TESTING RECOMMENDED PRIOR TO MEDICAL

ABORTION:

Ultrasound not necessary:

• regular menses

• patient is certain that their last menstrual period was within the prior 56 days

• no signs, symptoms or risk factors for ectopic pregnancy o Symptoms of ectopic pregnancy: light vaginal bleeding accompanied by lower abdominal or pelvic pain.

o Risk factors for ectopic pregnancy: previous ectopic pregnancy, prior tubal ligation or tubal surgery, IUD in place, history of pelvic inflammatory disease, endometriosis

Ultrasound should be considered:

• greater than 56 days since last menstrual period

• patient is uncertain of last menstrual period

• risk factors for ectopic pregnancy

• signs/symptoms of ectopic pregnancy (e.g., vaginal bleeding, pelvic pain)

Rh typing and administration of anti-d immunoglobulin:

mailto:VHACOReproductiveHealthTeam@va.gov https://www.acog.org/womens-health/faqs/induced-abortion https://dvagov.sharepoint.com/:b:/r/sites/VHAWomensHealth/SiteAssets/repr/Abortion/GenBioPro%20Mife%20Patient%20Agreement%20Form.pdf?csf=1&web=1&e=nTncYa https://dvagov.sharepoint.com/:b:/r/sites/VHAWomensHealth/SiteAssets/repr/Abortion/Mifeprex%20Medication%20Guide.pdf?csf=1&web=1&e=4hFv5T

Last updated: March 1, 2023

• Evidence does not support blood-typing and administration of anti-D immunoglobulin if the gestational age on the anticipated mifepristone ingestion date will be <70 days.

Hematocrit and hemoglobin:

• Obtain if anemia is known or suspected

Pregnancy testing:

• Positive pregnancy test (home pregnancy test is acceptable)

• Serum quantitative βhCG only needed if plan is to follow serial quantitative βhCG after procedure. This is a matter of patient-clinician preference.

CLINICAL ELIGIBILITY AND CONTRAINDICATIONS

Most patients at 70 days of gestation or fewer who are eligible for an abortion under VA policy are candidates for a medication abortion.

Contraindications:

1. Known or suspected ectopic pregnancy

2. Allergy or intolerance to misoprostol or mifepristone*

3. Inherited porphyria*

4. Chronic adrenal failure*

Precautions:

1. IUD in place (need to rule out ectopic pregnancy due to significant increased risk with IUD in place; if intrauterine pregnancy, IUD can be removed prior to medical abortion)

2. Severe uncontrolled asthma or current long term corticosteroid therapy

3. Known coagulopathy or current anticoagulant therapy

4. Significant co-morbidities that may require stabilization prior to treatment

5. Known anemia <9.5g/dL as safety has not been studied and risk of transfusion, though low (<0.1%), is higher than with surgical evacuation

*only for regimens including mifepristone

Beyond medical contraindications/precautions for medication abortion, the following are considerations for the clinician that may require additional counseling and/or result in offering only in-clinic aspiration abortion procedure:

• Patients who have difficulty with follow up (e.g., patients who have complex social considerations that may limit follow up)

• Patients unwilling to have uterine aspiration if medication abortion should fail

• Patient’s distance from a hospital (>60-minute drive from a hospital may be considered a contraindication)

• Patient’s access to a support person to be available while undergoing medication abortion to assist them with accessing care if having signs or symptoms concerning for a complication mailto:VHACOReproductiveHealthTeam@va.gov

Last updated: March 1, 2023

Provide the following:

• Mifepristone 200 mg orally x 1

• Misoprostol 800 micrograms (buccally or vaginally) x 2 doses

• Analgesics (e.g., NSAID, Tylenol) and antiemetics per clinician (see Plan for

Management of Side Effects, below).

• Patient instruction sheet and health facility emergency contact information

• Two high sensitivity pregnancy tests (HSPTs)

• Contraception as indicated. Provide any contraception except for intrauterine device or depo medroxyprogesterone acetate (Depo-Provera), both of which must be delayed until pregnancy is expulsed. If in-person follow-up is delayed, consider offering a bridge or barrier contraceptive method and counsel the patient that return to ovulatory function is within 7 days after abortion.

The Veteran should take mifepristone 200 mg orally followed by misoprostol 800 micrograms buccally or vaginally 24-48 hours later.

• Pregnant people with estimated GA >63 days should take a second dose of misoprostol 800 micrograms 4 hours after the first

• Pregnant people with estimated GA ≤63 days should take the second dose if no bleeding occurs within the first 24 hours after the first misoprostol dose

• Review the instruction sheet with the pregnant Veteran.

Plan for Management of Side Effects:

Crampy pain:

• Non-steroidal anti-inflammatory drugs (NSAIDS) o Sample regimen: ibuprofen 800mg po Q8 hours prn pain

• Opioids if needed o Hydrocodone-acetaminophen 5/325mg, 1-2 tabs, po Q4-6 hours prn pain, dispense 4 tablets Nausea:

• Sample regimen: Promethazine 25mg po Q4-6 hours prn nausea

• Sample regimen: Ondansetron (Zofran) 8mg po Q8 hours prn nausea

Last updated: March 1, 2023

Rule out Contraindications q Allergy to mifepristone or misoprostol q Inherited porphyria q Long term oral steroid use q Chronic adrenal failure q Hemorrhagic disorders q Anticoagulant therapy

Assess need for ultrasound (US)

Gestational age may be >70 days q 1 st positive pregnancy test >6 weeks ago q LMP >70 days from prior visit q LMP uncertain by more than 1 week q Menstrual cycles are irregular q LMP did not feel like normal menses

Increased ectopic pregnancy risk q Prior ectopic pregnancy q IUD in place at the time of conception q Vaginal bleeding since LMP q Unilateral pelvic pain q History of tubal surgery or PID

If any checked, ultrasound indicated prior to

MAB: schedule ultrasound within 7 days

If any checked, ultrasound needed to rule out ectopic: schedule urgent ultrasound

Assess needs for labs (not routinely needed) q Anemia: check HGB/Hct if last HGB <10 or Hct <30%, or if history of severe anemia and no recent HGB/Hct q Rh testing: Not routinely needed for 1 st trimester AB but may be offered (give Rhogam within 72 hours of mife if Rh-) q βhCG: not needed unless plan to confirm

Virtual care: telehealth and medications via mail OR In-person appointment q Telehealth and no US or labs needed: schedule or proceed with telehealth visit q Telehealth but needs US or labs: schedule US or lab appointment and schedule follow-up telehealth visit for med dispensing once confirmed to be medically eligible

Yes

No

Last updated: March 1, 2023

Schedule follow-up:

In-person or by phone/telehealth

In-person follow-up (at ~7 days) q Confirm abortion complete by clinical history and either:

q Pre and post ultrasound q 80% drop in serum βhCG by 7 days (initial βhCG within 3 days of using mifepristone) q Negative urine hCG at 4 weeks q Offer contraception

Telehealth follow-up

Telehealth visit – days (provider) q If patient and provider think MAB is complete:

schedule follow-up call in 4 weeks to review urine pregnancy test results q If patient or provider think MAB is NOT complete:

schedule ultrasound q Offer contraception

Phone call or Telehealth visit 4 weeks (provider or RN) q Ensure home urine pregnancy hCG test negative, urgent evaluation if positive

OTHER CLINICAL CONSIDERATIONS:

1. Gestational age: In general, efficacy rates are approximately 92-98%. At gestational ages of 64-70 days efficacy rates are similar to gestational ages of <63 days with two

800 mcg doses of misoprostol taken four hours apart (3).

2. Route of misoprostol administration: In general, vaginal and buccal administration are associated with increased efficiency, decreased ongoing pregnancy rates and allow an increased gestational age range for medication abortion compared to oral misoprostol administration (4).

• Vaginal administration is associated with fewer gastrointestinal side effects compared with buccal administration (2).

3. Timing of misoprostol administration after mifepristone: In general, there is equivalent efficacy among non-oral regimens with intervals of 24-36 hours. An interval of 24 hours appears to have the highest efficacy.

• For intervals <24 hours, vaginal misoprostol should be encouraged because of higher efficacy. Buccal administration is not as effective when given at the same time as mifepristone (2).

4. Medication abortion without definitive intrauterine pregnancy (IUP): Medication abortion can be provided without prior ultrasound in some circumstances (see Evaluation and Ancillary Testing Recommended Prior to Medication Abortion above).

For those patients who do require ultrasound, and a definitive IUP is not identified, medication abortion can be performed when ectopic pregnancy is unlikely based on criteria above, with counseling and close follow up.

Last updated: March 1, 2023

5. Antibiotics: Routine administration of prophylactic antibiotics is not recommended.

The risk of infection after first trimester medical abortion is approximately 0.3% (5)

FOLLOW UP:

Standard follow up after medication abortion includes clinical evaluation 1-2 weeks following the first visit for medication abortion.

In-person clinical follow up. Although ultrasound is commonly performed it is not required. If an ultrasound is performed, the sole purpose should be for the documentation of the presence or absence of a gestational sac. Endometrial thickness does not indicate failed medication abortion. (1)

Contraception and family planning counseling should be offered at the time of follow-up, if not initiated at the time of abortion care.

Many people travel great distances to obtain medication abortion and in-person follow up may not be feasible. The following are acceptable alternatives to in-person follow up:

Laboratory follow-up (optional): Serum quantitative βhCG on day of Mifepristone compared to quantitative serum βhCG one week later:

• A decline in the serum βhCG measurement of 80% from day of mifepristone administration compared to 1 week later is indicative of success (1). Patients may have their follow-up βhCG drawn at the closest VA facility.

• There is limited data on this approach for gestations greater than 63 days.

Telephone follow up: Follow up can be performed by telephone at 1 week with subsequent clinic or at home highly sensitive urine testing 4 weeks after treatment. Two pregnancy tests should be mailed to the Veteran if telephone follow-up is planned. This avoids the need for the patient to present to the facility. (1)

How is incomplete medication abortion or ongoing pregnancy managed?

An incomplete medication abortion is defined as delayed expulsion or ongoing pregnancy. The incidence of incomplete medication abortion is low. If diagnosis is unclear consult with specialist.

Managing incomplete medication abortion or ongoing pregnancy:

1. Plan a follow-up contact with the patient one week after dispensing treatment.

2. If the patient reports indicators of continuing pregnancy or ectopic pregnancy, evaluate with pelvic ultrasound AND serum quantitative βhCG.

3. If the patient does not report indicators of continuing pregnancy or ectopic pregnancy, then instruct the patient to perform the first highly sensitive pregnancy test

Last updated: March 1, 2023

(HSPT) 4 weeks after taking misoprostol (not earlier) and to contact their healthcare team if the result is positive.

4. If the first HSPT result is positive, but the patient has no indicators of continuing pregnancy or ectopic pregnancy, instruct the patient to perform the second HSPT in 1 week

5. If the second HSPT result is also positive, evaluate with pelvic ultrasound, serum quantitative βhCG, additional urine testing, or uterine aspiration.

Delayed Expulsion

In the absence of excessive bleeding or pain clinicians can monitor patients based on symptoms.

Incomplete Medication Abortion

An incomplete abortion can be treated with a repeat dose of misoprostol, uterine aspiration, or expectant management depending on the clinical circumstances and patient preference.

Ongoing Pregnancy

Ongoing pregnancy can be treated with a repeat dose of misoprostol, uterine aspiration, or expectant management depending on the clinical circumstances and patient preference.

References

1. ACOG Practice Bulletin Medical abortion up to 70 days gestation 2020;136(4) e31-e46

2. Creinin MD, Danielsson K. Medical abortion in early pregnancy. In: Paul M, Lichtenberg S, Borgatta L, Grimes D, Subblefield P, Creinin M, editors.

Management of Unintended and Abnormal Pregnancy: Comprehensive Abortion Care. Wiley- Blackwell; 2009.

3. National Abortion Federation. 2020 Clinical Policy Guidelines for Abortion Care.

4. Medical Management of First-Trimester Abortion - ACOG [Internet]. Available from: http://www.acog.org/Resources-And-Publications/Practice- Bulletins/Committee-on-Practice-Bulletins-Gynecology/Medical-Management-of- First-Trimester-Abortion

5. Goldstone P, Michelson J, Williamson E. Effectiveness of early medical abortion using low-dose mifepristone and buccal misoprostol in women with no defined intrauterine gestational sac. Contraception. 2013 Jun;87(6):855–8.

6. Achilles SL, Reeves MF, Society of Family Planning. Prevention of infection after induced abortion: release date October 2010: SFP guideline 20102.

Contraception. 2011 Apr;83(4):295–309.

Last updated: March 1, 2023

7. Perreira LK et al. Feasibility of telephone follow up after medical abortion.

Contraception 2010(81):143-9.

8. Chen MJ et al. Comparing office and telephone follow up after medical abortion.

Contraception 2016(94):122-6.

9. Ipas. Medical Abortion Contraindications and Precautions, last reviewed January 22, 2021. Accessed 8/25/22. https://www.ipas.org/clinical-update/english/general-recommendations/medical-abortion-contraindications-and-precautions/ https://www.ipas.org/clinical-update/english/general-recommendations/medical-abortion-contraindications-and-precautions/ https://www.ipas.org/clinical-update/english/general-recommendations/medical-abortion-contraindications-and-precautions/ https://www.ipas.org/clinical-update/english/general-recommendations/medical-abortion-contraindications-and-precautions/