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Time for Action: Managing Early Pregnancy Loss and Medication Abortion in Primary Care

CME Medical Care of Vulnerable and Underserved Populations Jessica Beaman, MD MPH Assistant Professor of Medicine Division of General Internal Medicine at ZSFG

Disclosures

• I have no financial disclosures
• I present off-label indications for mifepristone and misoprostol

“We acknowledge our awareness of the sensitive and emotional nature of the abortion controversy; of the vigorous opposing views, even among physicians.”

• - From Justice Harry A. Blackmun’s majority opinion in Roe v. Wade (January 22, 1973)

Learning Objectives

1.

Describe early pregnancy loss and abortion trends in the United States

2.

Analyze current evidence for medical management of early pregnancy loss and medication abortion

3.

Effectively counsel your patients about medical management

• f early pregnancy loss and medication abortion

4.

List key clinical and legal considerations for integration of mifepristone in to practice

Learning Objectives

1.

Describe early pregnancy loss and abortion trends in the United States

2.

Analyze current evidence for medical management of early pregnancy loss and medication abortion

3.

Effectively counsel your patients about medical management

• f early pregnancy loss and medication abortion

4.

List key clinical and legal considerations for integration of mifepristone in to practice

Overview

Terminology

• Distinct clinical conditions
• Early pregnancy loss (EPL) = nonviable, intrauterine pregnancy

before 13 weeks gestation

• Commonly referred to as miscarriage
• Elective abortion = when a medication is taken or a procedure is

performed to end a pregnancy

• Also called an induced abortion, pregnancy termination, or abortion

Reproductive age women in primary care

• 61 million US women of reproductive age (15-44)
• 10% become pregnant annually
• Half of all US women will seek primary care in an internal

medicine or family medicine clinic each year

Prenatal Care

“

“On average, U.S. women want to have two children. To accomplish that goal, a woman will spend close to three years pregnant, postpartum, or attempting to become pregnant, and about three decades… trying to avoid an unintended pregnancy.”

Sonfield et al.

From in “Moving Forward: Family Planning in the Era of Health Reform” (2014)

Lifetime Prevalence of Common Medical Conditions

Lifetime Prevalence (%)

Perce nt Breast Cancer Cervical Cancer Depression Diabetes Hypertension

Breast Cancer Cervical Cancer Depression Diabetes Hypertension

Unintended Pregnancy is Common

Unintended Pregnancy Cervical Cancer Diabetes Hypertension Breast Cancer Depression

Lifetime Prevalence (%)

Unintended Pregnancy

• 45% of all pregnancies are

unintended

• Mistimed = wants to become

pregnant in the future but not at the time she became pregnant

• Unwanted = did not want to

become pregnant then or at any time in the future

Pregnancy Intentions

Outcomes of Pregnancy

Early Pregnancy Loss (EPL) Abortion

• Estimated that 10-20% of

all pregnancies end in EPL

• 80% of all pregnancy loss

is EPL

• Half of all unintended

pregnancies end in abortion

• 1 in 4 women will have an

abortion by age 45 (20% by age 30)

Over 1/3 of all pregnancies result in EPL or elective abortion

Trends in Early Pregnancy Loss

• Self-reported early pregnancy loss rate

is increasing in US

• 22,000 births
• Risk of EPL increased by 2% annually
• Exception = women 20-24 years old

Early Pregnancy Loss

• 50% of all cases of early pregnancy loss are due to fetal

chromosomal abnormalities

• Risk Factors
• Advanced maternal age
• 9-17% from 20-30 years
• 80% at 45 years
• Prior early pregnancy loss
• Substances (alcohol, caffeine, cigarette (> 10/day), cocaine)
• Comorbidities (e.g., APLS, DM, thyroid disease)

Trends in Abortion

Access to Care

90% of women live in US county without an abortion clinic

Impact on Patients

42 clinics 19 clinics

Impact on Patients

• Dark blue = no facility, > 100 miles

traveled

• Mean distance Δ = 51 miles
• Decrease in abortions

Turnaway Study (UCSF, 2018 and ongoing)

ANSIRH (Advancing New Standards in Reproductive Health)

• Large, longitudinal study (N=1000)
• 8000 interviews
• Women turned away based on GA
• Lasting impacts
• Unemployment/living below FPL
• In relationship w/ abusive partner
• Less likely to have aspirational plans
• No increased likelihood for:
• Depression
• Anxiety
• Suicidal ideation

Incorporating Abortion into Primary Care

• 2012 by Page et al
• 90 Patients in academic PCC
• 67% felt PCC should offer medical abortions
• 87% would want PCP to perform
• 2005 by Schwarz and Luetkemeyer
• 212 Residents, 11 residencies
• 42% IM residents willing to prescribe

medication abortion

• 2010 by Godfrey et al
• 299 Patients in NYC and Chicago
• 58% would choose primary care clinic (PCC)

for abortion

2018

Support Policies for Comprehensive Reproductive Health

• Well-suited to provide high-quality

women’s health care

• Should receive appropriate training
• Essential for women to have access to

comprehensive, nondiscriminatory health coverage

• Oppose legislations or regulations that

limit access, including abortion

2018

Support Policies for Comprehensive Reproductive Health

Overview

Summary

• PCPs care for reproductive-age women who have a high

likelihood of experiencing:

• Early pregnancy loss
• Unintended pregnancy
• Abortion
• Rates of early pregnancy loss are increasing
• Health disparities exist in who experiences abortion and has

access to care

• Patients and providers have shown interest in integrating

abortion care into primary care

Learning Objectives

1.

Describe early pregnancy loss and abortion trends in the United States

2.

Analyze current evidence for medical management of early pregnancy loss and medication abortion

3.

Effectively counsel your patients about medical management

• f early pregnancy loss and medication abortion

4.

List key clinical and legal considerations for integration of mifepristone in to practice

Evidence

Early Pregnancy Loss Management

• EPL management has traditionally been one of the following:
• Expectant management (days to weeks)
• Day 7 – 50%  Day 46 = 90%
• Medications
• D&C procedure
• Medication protocols
• Misoprostol alone
• Mifepristone and misoprostol

Early Pregnancy Loss Management

• EPL management has traditionally been one of the following:
• Expectant management (days to weeks)
• Day 7 – 50%  Day 46 = 90%
• Medications = patient preference
• D&C procedure
• Medication protocols
• Misoprostol alone
• Mifepristone and misoprostol

Medications for EPL

• Mifepristone: A progesterone receptor blocker
• Leads to detachment of pregnancy from endometrium
• Also softens/ripens cervix and primes myometrium for misoprostol
• Misoprostol: A prostaglandin analogue
• Stimulates uterine contractions

Update in Medical Management for EPL

June 7, 2018

Study Details

• Women experiencing an EPL between 5-12 weeks gestation
• N = 300
• Randomized to:
• Misoprostol-alone (800 µg of vaginal misoprostol)
• Mifepristone-pretreatment group (200mg oral mifepristone

followed by 800 µg of vaginal misoprostol 24 hours later)*

• Primary outcomes:
• Gestational sac expulsion by first follow-up visit (24-72 hours)
• No additional intervention (e.g., additional misoprostol, D+C)

within 30 days of treatment

Study Details

• Women experiencing an EPL between 5-12 weeks gestation
• N = 300
• Randomized to:
• Misoprostol-alone (800 µg of vaginal misoprostol)
• Mifepristone-pretreatment group (200mg oral mifepristone

followed by 800 µg of vaginal misoprostol)

• Primary outcomes:
• Gestational sac expulsion by first follow-up visit
• No additional intervention (e.g., additional misoprostol, D+C)

within 30 days of treatment

Clinical Outcomes among Women Who Received Medical Treatment for Early Pregnancy Loss.

Clinical Outcomes among Women Who Received Medical Treatment for Early Pregnancy Loss.

Adverse Events among Women Who Received Medical Treatment for Early Pregnancy Loss.

ACOG Practice Bulletin on EPL: Revision

Mifepristone + Misoprostol for EPL is the BEST PRACTICE

Medication Regimen for EPL = Medication Abortion

First Trimester Abortion Management

• ~ 90% of abortions occur in first trimester
• Medication abortion can take place up to 70 days gestation or

10 weeks

• Women are increasingly choosing medication for early

abortions

• Of US abortion providers, 17% offer only medication abortion
• Improves access

Overview of Abortion

First Trimester Abortion

5 23 95 77 2001 2014 Medication Abortion Surgical Abortion

First Trimester Abortion

Medication Procedure

• Non-invasive
• No anesthesia
• Efficacy = 95-97%
• Can occur at home
• May need f/u medications or procedures
• Minimally invasive
• Usually anesthesia or local block
• Available later in pregnancy
• Efficacy = 98-99%
• Procedure < 10 minutes

Safety of Mifepristone and Abortion (2018)

• All forms of abortion are safe and effective
• Abortion can be safely performed in an office-

based setting

• No procedural skill needed for medication
• Does not increase risk of:
• Secondary infertility
• Breast cancer
• Depression/anxiety/PTSD
• Serious complications are < 1%

FDA-Labeling for Mifepristone

• REMS (Risk Evaluation and

Mitigation Strategies)

• 79 FDA-approved medications with

“serious safety concerns”

• Registration of clinicians in central

database

• Must be dispensed in-person
• No pharmacy
• No mail

FDA-Labeling for Mifepristone

• REMS
• Label updates

FDA Labeling Update

2000  2016

FDA-Labeling

• REMS
• Label updates
• Black Box warning
• Rare infection
• Clostridium sordellii
• Clostridium perfringens

Current Evidence

Summary

• EPL may be managed in one of three ways: expectant,

medication, or procedure

• The most effective medication regimen for EPL management

is mifepristone followed by misoprostol

• Mifepristone is safe and efficacious for use in both EPL and

abortion

• One must be aware of the REMS for mifepristone to comply

with federal regulations for dispensing of medication

Learning Objectives

1.

Describe early pregnancy loss and abortion trends in the United States

2.

Analyze current evidence for medical management of early pregnancy loss and medication abortion

3.

Effectively counsel your patients about medical management

• f early pregnancy loss and medication abortion

4.

List key clinical and legal considerations for integration of mifepristone in to practice

Counseling

Counseling Patients

General Principles

• Preference-sensitive counseling
• Use language and tone that demonstrate respect
• Patient-centered communication (e.g., open-ended questions,

nonjudgmental listening)

• Options counseling
• EPL: patient treatment priorities for miscarriage
• Unintended pregnancy: abortion, adoption, parenting
• Address specific patient concerns/preferences and provide

anticipatory guidance

Pregnancy Options Counseling Framework

TEACH Early Abortion Training Workbook

What about contraceptive counseling?

• Timing
• 61% of patients reported they did not want to discuss

contraception (N=1959)

• History of reproductive injustices
• Involuntary sterilization
• CA: 150 inmates from 2006 to 2010 undergoing

sterilization --> Gov. Jerry Brown signs SB 1135 (Prison Anti-Sterilization Bill, 2014)

• Probation
• TN: 2009 case of 21-year-old undergoing court
• rdered tubal ligation
• Provider bias

Contraceptive Counseling

Contraceptive Counseling

• N=524 (OB/FM)
• Low SES Black and Latina

patients were most likely to have IUD recommended

• Low SES > High SES

Counseling re: Mifepristone and Misoprostol

• Review how to take medications (two-step process)
• Misoprostol can be taken 0-72 hours after mifepristone
• Timing depends on route
• Anticipatory guidance
• Symptoms – what is normal, what is not
• Return precautions and who to call/where to go for care
• Impact on patients
• EPL associated with grief, depression, and anxiety
• Abortion with no increased risk of depression, anxiety, SI though

certainly can be associated with grief, sadness, guilt, or shame

Patient Counseling

Summary

• Preference-sensitive counseling is key
• Tools and frameworks are available online to support patients

in decisions related to EPL and abortion

• Consider patient preference and provider bias in discussions
• f contraceptive counseling, especially in regards to EPL and

abortion

• Counseling for EPL and abortion should include a review of

the medications, anticipatory guidance, and patient support

Learning Objectives

1.

Describe early pregnancy loss and abortion trends in the United States

2.

Analyze current evidence for medical management of early pregnancy loss and medication abortion

3.

Effectively counsel your patients about medical management

• f early pregnancy loss and medication abortion

4.

List key clinical and legal considerations for integration of mifepristone in to practice

Clinical Considerations

Mifepristone in Primary Care

For EPL and Medication Abortion

• Power to destigmatize
• Know and engage key

stakeholders

• Changes to culture/practice
• Patient satisfaction:
• Achieving rapid appointment access
• Staff courtesy
• Ready information to questions

Who can provide mifepristone?

• 42 states require clinics who

perform medication abortions to be physicians

• Know your state laws
• Guttmacher Institute
• “An Overview of Abortion Laws”

(Updated Feb, 1 2019)

State-Based Abortion Restrictions

Clinic Protocol: 5 Key Items

• 1. Consent and eligibility
• 2. Labs
• 3. Storing/administering pills +

Rhogam prn

• 4. Patient calls
• 5. Referrals

Clinic Protocol: 5 Key Items

• 1. Consent and eligibility
• 2. Labs
• 3. Storing/administering pills +

Rhogam prn

• 4. Patient calls
• 5. Referrals

• 1. Consent

Available from Danco website (manufactures, markets, distributes mifepristone as Mifeprex)

• 1. Eligibility
• Clinical dating
• LMP equivalent to U/S
• Alternative: serial beta hCG
• Rule out contraindications:
• IUD in place
• Allergy to prostaglandins or mifepristone
• Chronic adrenal failure or long-term systemic corticosteroid therapy
• Known or suspected ectopic pregnancy
• Hemorrhagic disorders or concurrent anticoagulant therapy
• Inherited porphyria

Clinic Protocol: 5 Key Items

• 1. Consent
• 2. Labs – CBC, Rh, +/- beta hCG
• Consider safety if Hb < 10
• 3. Storing/administering pills +

Rhogam prn

• 4. Patient calls
• 5. Referrals

Clinic Protocol: 5 Key Items

• 1. Consent
• 2. Labs – CBC, Rh, +/- beta hCG
• 3. Storing/administering pills +

Rhogam prn

• Rhogam 50mcg IM within 72 hours of

mifepristone

• 4. Patient calls
• 5. Referrals

• 3. Administering Pills

Protocol (from RHAP) FDA Regimen 2016 Buccal Misoprostol Alternative: Vaginal Misoprostol Mifepristone dose/location 200mg orally Dispensed in office Same Misoprostol dose/route 800 mcg buccally 800 mcg vaginally Misoprostol timing 24-48 hours after mifepristone 6-72 hours after mifepristone Misoprostol location Home Same Follow-up/location 7-14 days after mifepristone Location not specified 7-14 days after mifepristone Office or alternative

Clinic Protocol: 5 Key Items

• 1. Consent
• 2. Labs – CBC, Rh, +/- beta-hCG
• 3. Storing/administering pills +

Rhogam prn

• 4. Patient calls
• 5. Referrals

• 4. Patient Calls
• Common side effects of misoprostol:
• GI: Nausea/vomiting/diarrhea
• Low grade fevers/chills/myalgias are common
• Usually resolve within 6 hours of use
• Pain management
• Changes in menses
• Heavy first menses is common following mifepristone and

misoprostol

Pain Management

• Mean pain score = 5.5 +/- 2.2
• Ibuprofen vs opiates vs pregabalin
• Most women use two 800mg

tablets

• Quick recovery
• 12 hrs after miso 46-82% with no

pain

Rx: Ibuprofen 600-800mg q6-8h

Clinic Protocol: 5 Key Items

• 1. Consent
• 2. Labs – CBC, Rh, +/- beta-hCG
• 3. Storing/administering pills +

Rhogam prn

• 4. Patient calls
• 5. Referrals
• Ultrasound, transfusion, vacuum aspiration

What You Don’t Need

No need to perform a pap smear or test for STIs

Anticipatory Guidance/Return Precautions

• No bleeding 24 hours after misoprostol
• Soaked > 2 maxi-pads for > 2 consecutive

hours

• Unmanageable pain
• Sustained fever > 100.4 or onset of fever >

24 hours after misoprostol

• Abdominal pain, weakness, “feeling sick”,

nausea, vomiting, or diarrhea > 24 hours after misoprostol

• Must provide emergency contact service
• n 24 hour basis

Follow-up

Up to day 14

• In-person or not
• Ultrasound = absence of gestational sac or embryo
• Endometrial thickening is normal unless accompanied by symptoms
• Serial hCG
• Decrease from baseline hCG of 60% in 6-10 days of treatment
• Self-assessment is non-inferior to routine follow-up

Legal Considerations

• Affirm right to abortion in state constitution (9

states)

• Medicaid coverage for abortion (15 states)
• Allow non-physicians to provide abortion (8

states)

• Mandate private health insurance plans cover

abortion (3 states)

Types of Regulations

Physician/Clinic Patient

• Physician-only (42)
• Two physicians (19)
• Hospital-based (19)
• Public funding (33)
• Private insurance (11)
• Gestational limits (43)
• State-mandated counseling (18)
• Waiting periods (27)
• Parental involvement (37)

State-Based Abortion Restrictions

What to do if you are a CHC

RHAP FAQ on Integrating Medication Abortion Care into CHC

HHS Revision to Title X Funding

February 22, 2019

• Proposed revision on June 1, 2018
• Received 500,000 comments
• Final ruling:
• Clear financial AND physical separation

between Title X funded projects/programs in facilities where abortion is offered

• Prohibit use of Title X funds to perform,

promote, refer for, or support abortion for family planning

• Permits, but no longer requires, nondirective

pregnancy counseling (including on abortion)

• Takes effect in 60 days
• Physical separation (1 year)

What to do if you are a CHC

RHAP FAQ on Integrating Medication Abortion Care into CHC

• Separation of funds (Title X versus 330 funds)
• Malpractice insurance
• If CHC is FQHC and purchases FQHC insurance from federal

gov’t then policy excludes abortion services

• Miscarriage management (medications, MVA) are covered
• Safety concerns
• Stakeholders
• Expense (Mifepristone = $90 each)

Legal Resources

For integrating mifepristone in to your clinic

• ACLU Reproductive Freedom Project
• The Guttmacher Institute
• Physicians for Reproductive Health
• National Abortion Federation
• Reproductive Health Access Project
• Regional clusters and national IM cluster
• (Danco)

Highlight: Future Study

UCSF + Multiple Community Sites

• Expanding primary-care provision of medication abortion via

mail-order mifepristone

• Recruiting for primary care sites to start later this year
• Sites will receive training, materials, ongoing support,

reimbursement for services

• After evaluation by clinician, patients will obtain medications from

mail-order pharmacy and will be asked to complete 2 surveys

• If interested, email Daniel.Grossman@UCSF.edu or

Jessica.Beaman@UCSF.edu

Conclusion

Summary

• Mifepristone is safe and effective in the management of both

EPL and abortion

• The medication regimen for mifepristone is identical in EPL

and abortion

• Mifepristone can be provided safely by clinicians working in a

wide range of clinical settings

• Expanding the number of clinicians who have integrated

mifepristone in to their clinical practice is a simple way to provide high-quality comprehensive women’s health care for

• ur patients

Eligibility and Exclusion Criteria: Mife + Miso

• Eligibility criteria: < 70 days desiring medication abortion
• Exclusion criteria:
• IUD in place (must be removed prior to administration of the

medications)

• Allergy to prostaglandins (misoprostol) or mifepristone
• Chronic adrenal failure or long-term systemic corticosteroid therapy
• Known or suspected ectopic pregnancy
• Hemorrhagic disorders or concurrent anticoagulant therapy
• Inherited porphyria

Efficacy of Mifepristone and Misoprostol for Abortion

• Most studies = ~95%
• Society of Family Planning Guidelines (2014)
• 92% up to 49 days
• 85% from 49-70 days
• TEACH Workbook (Chen and Creinin 2015)
• 95-99% up to 63 days
• 91-94% from 64-70 days
• Danco Label
• 96-97% effective through 70 days