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1 I. Title: Ensuring Support for and Access to Self-Managed Abortion 2 3 II. Author Identification 4 • Monique Baumont, Center for , 199 Water St, 22nd Floor, , NY 5 10038, [email protected], Member #10432693, Sexual and Reproductive Health 6 Section 7 • Bonnie K Epstein, unaffiliated, 4403 Riverview Ave, Englewood, NJ 07631, 8 [email protected]. Member #9855820, Sexual and Reproductive Health Section. 9 • Caitlin Phelps, American College of Obstetricians and Gynecologists, 409 12th Street, SW 10 , DC 20024-2188, [email protected], Member #9847505, Sexual and Reproductive 11 Health Section 12 • Silpa Srinivasulu, Reproductive Health Access Project, P.O. Box 21191, New York, NY 10025, 13 [email protected], Member #10338166, Sexual and Reproductive Health Section 14 15 III. Co-Sponsorship: Sexual and Reproductive Health Section 16 17 IV. Collaborating Units: N/A 18 19 V. Endorsement: International Health Section 20 21 VI. Summary 22 Access to abortion care is essential to the health, well-being, and bodily autonomy of pregnant 23 people and their families. While the right to abortion is constitutionally protected in the U.S., restrictive 24 state and federal legislation and regulations have eroded this right. These policies have exacerbated 25 structural inequities to undermine and impede access to care, disproportionately affecting Black, 26 Indigenous, and people of color, those with lower incomes, immigrants, and people in rural areas. Due to 27 logistical and financial barriers to accessing abortion care, and some people’s personal preferences and 28 experiences of stigma and structural racism with respect to the medical system, there has been 29 considerable growth in demand for self-managed abortion in the U.S. Yet, some police and prosecutors 30 continue to misuse state laws to criminalize people who end their pregnancies outside of a medical 31 context or people who support them. Moreover, unnecessary restrictions and regulations prevent people 32 from having full access to safe and effective medications to self-manage their . The desire to 33 stay at home throughout the COVID-19 pandemic and avoid potential virus exposure has heightened 34 interest in this care, making it particularly important to establish and strengthen the public health

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1 community’s support for self-managed abortion. This policy statement recommends that APHA members, 2 public health professionals, clinicians, and elected officials denounce the criminalization of self-managed 3 abortion, including the criminalization of those who provide support, and work toward guaranteeing safe 4 and equitable access to the full-range of safe abortion care options, including self-managed abortion. 5 6 Relationship to Existing APHA Policy Statements 7 ● #20152: Restricted Access to Abortion Violates Human Rights, Precludes Reproductive Justice, 8 and Demands Public Health Intervention 9 ● #20083: Need for State Legislation Protecting and Enhancing Women’s Ability to Obtain Safe, 10 Legal Abortion Services Without Delay or Government Interference 11 ● #20112: Provision of Abortion Care by Advanced Practice Nurses and Physician Assistants 12 ● #201113: Call to Action to Reduce Global Maternal, Neonatal, and Child Morbidity and 13 Mortality 14 ● #20139: Renouncing the Adoption or Misapplication of Laws to Recognize Fetuses as 15 Independent of Pregnant Women 16 ● #20199: Preventing and Reducing the Harm of the Protecting Life in Global Health Assistance 17 Policy in Global Health 18 ● #200314: Support for Sexual and Reproductive Health and Rights in the and 19 Abroad 20 ● #20153: Universal Access to Contraception 21 22 VII. Rationale for Consideration 23 This is a new policy statement about public health and medical professionals’ responsibility to 24 support people’s rights to access the full-range of safe abortion care options free from criminalization or 25 unnecessary restrictions, including self-managed abortion. This policy statement does not replace or 26 update an existing one. APHA has identified the need to address self-managed abortion as demand for 27 this option came to the forefront during the COVID-19 pandemic. Self-managed abortion with medication 28 for those who prefer it is safe, effective, and enhances bodily autonomy. Over the last five years we have 29 witnessed increasingly restrictive state mandates on abortion leading to clinic closures, delays in care, and 30 logistical and financial barriers. Self-managed abortion would address these issues. Given accurate 31 information, self-managed abortion is as safe as clinic-based care. APHA has a long history of 32 recognizing access to safe abortion care as a public health issue and has demonstrated support for 33 reproductive justice, particularly pregnant people’s bodily autonomy. APHA has several abortion-related 34 policies, but none that specifically address self-managed abortion.

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1 VIII. Problem Statement 2 In the past decade, abortion access has become increasingly restricted in the U.S. Since 2011, 3 nearly 500 abortion restrictions have been enacted, including laws banning abortion in certain 4 circumstances and laws that impose medically unnecessary requirements on abortion care (1). Studies of 5 multiple states, like Texas, Georgia, and Ohio, have demonstrated adverse impacts of restrictive state- 6 level laws on access to abortion care, including delays in accessing care due to increased travel distance; 7 economic burdens from lost wages, childcare, and travel costs; increased stigma; and reduced abortion 8 rates (2-5). These barriers disproportionately impact Black, Indigenous, and people of color, low-income 9 people, immigrants, people with disabilities, members of the LGBTQ community, and people living in 10 rural and medically underserved areas (4). Despite the constitutional right to abortion, for many, state 11 restrictions interact with structural inequities to place abortion care entirely out of reach. 12 Self-managed abortion represents an alternative to clinical care for individuals facing barriers due 13 to abortion restrictions or who prefer this method. Self-managed abortion occurs when an individual 14 performs their own abortion outside of a formal medical setting or without clinical supervision and can 15 include ingesting herbs, using and or misoprostol only (known as medication 16 abortion), inserting objects into the vagina, or other methods (6). 17 Researchers have documented considerable demand for self-managed abortion in the U.S. 18 Approximately 7% of U.S. women will self-manage abortion at some point in their lives, using a variety 19 of methods (7). A study of requests from U.S. residents for self-managed medication abortion through the 20 online telemedicine abortion service Women on Web from October 15, 2017 to August 15, 2018 21 identified 6,022 requests, three-quarters of which were from individuals living in states hostile to abortion 22 (8). Barriers to accessing abortion care during the COVID-19 pandemic have led to further increases in 23 demand. Based on data from the online medication abortion service Aid Access, there was a statistically 24 significant increase of 27% in the rate of requests for self-managed medication abortion from March 20, 25 2020 to April 11, 2020 compared to before the pandemic (8). Since these studies only measured a single 26 pathway to self-managed abortion, actual demand is likely much higher. 27 In exploring reasons for self-management, qualitative research identified that some individuals 28 seek self-managed abortion due to financial and logistical barriers to accessing clinical care, while others 29 prefer the privacy, comfort, and convenience offered by self-managed abortion (9). Subsequent 30 quantitative research similarly found that the majority of people report seeking self-managed abortion due 31 to both barriers and preferences, with cost, distance, inability to locate a clinic, and legal restrictions all 32 cited as barriers to clinical care, particularly in states hostile to abortion (7, 8). A nationally representative 33 study found that the prevalence of self-managed abortion was nearly three times higher among Black 34 women than White women and elevated among Hispanic individuals, indicating that they may face

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1 heightened barriers to accessing clinical care or have a stronger preference for self-managed abortion due 2 to experiences of stigma, discrimination, and structural racism (7). 3 Despite considerable demand for self-managed abortion among pregnant people who prefer this 4 method or are unable to access clinical care due to state restrictions, numerous barriers, including threat of 5 criminalization and restrictions on the availability of medication, prevent people from self-managing their 6 abortion safely and with support. 7 Risk of Prosecution 8 State laws have been misapplied by police and prosecutors to punish people for self-managing 9 their abortion or for supporting those who self-manage, creating stigma and fear. As of 2020, five states 10 had antiquated laws criminalizing self-managed abortion despite the constitutionally protected right to 11 abortion (10). Due to stigma and anti-abortion political motivations, police and prosecutors in other states 12 may misuse or ignore the legislative intent of laws criminalizing harm to fetuses, governing the disposal 13 of human remains, and others to target people who have self-managed their abortion and/or those who 14 support them (11). In 2020, 13 states had criminal abortion laws that could be misapplied to people who 15 self-manage, and nine states had laws criminalizing harm to fetuses by pregnant people (10). Due to these 16 harmful laws, at least 21 people in the U.S. have been arrested for ending their pregnancies or helping 17 others do so since 2000 (10). Laws that indirectly or directly criminalize self-managed abortion are likely 18 to be disproportionately used against people of color, immigrants, and other marginalized communities, 19 who already experience over-policing and over-incarceration. 20 The threat of prosecution, including the risk of being reported to law enforcement by one’s 21 doctor, impedes the public health priority of maintaining trust in the health care system and ensuring 22 access to information and medical care for people who self-manage abortion. This may prevent people 23 from using their preferred method of care due to fear of prosecution and increase the risk of negative 24 health outcomes by deterring people who self-manage from seeking care for adverse effects or 25 complications (12). The threat of criminalization may also negatively impact quality of care by preventing 26 people and organizations from assisting individuals with the self-managed abortion process. 27 Self-Managed Medication Abortion 28 Medication abortion is a safe, effective, and increasingly common method of self-managed 29 abortion. Despite its safety record, multiple policy and regulatory barriers prevent people who prefer this 30 method of self-management from being able to access the medications. The mifepristone and misoprostol 31 or misoprostol-only regimens for medication abortion is supported by both U.S. and international medical 32 organizations (13, 14). Both mifepristone and misoprostol are included in the World Health Organization 33 (WHO) Model List of Essential Medicines (14), indicating that they should be available and accessible by 34 health systems at all times. The regimen for medication abortion approved by the U.S. Food and Drug

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1 Administration (FDA) is 200mg of mifepristone taken orally, followed by 800mcg of misoprostol taken 2 buccally or vaginally 24 to 48 hours later (15). Most pregnant people who desire a medication abortion , 3 including those with conditions like asthma and multiple gestations, are eligible and have no 4 contraindication that would prevent this approach (13). The strong body of literature demonstrating the 5 ability of reproductive age individuals to self-screen for hormonal contraception suggests similar self- 6 screening could be accomplished without a provider for medication abortion. 7 Mifepristone and misoprostol are safe and effective for terminating a pregnancy. U.S. trials of 8 16,794 pregnant people found the regimen 97.4% effective through 70 days gestation (15). Complications 9 after medication abortion are very rare and occur in only a fraction of a percent of patients (16). The FDA 10 confirms that medication abortion’s “efficacy and safety have become well-established by both 11 researchers and experience, and serious complications have proven to be extremely rare” (17). The 12 misoprostol-only regimen is a safe, effective alternative to mifepristone with misoprostol (13, 18). 13 While stigma and restrictive legal contexts make it difficult to generate a plethora of evidence on 14 medication for self-managed abortion, research has found that self-managed medication abortion with 15 accurate information is safe and effective. A study of more than 1000 Women on Web clients from the 16 Republic of Ireland and Northern Ireland found that outcomes compared favorably with in-clinic 17 medication abortion, rates of adverse events were low, and clients were able to self-identify symptoms of 18 potentially serious complications and seek further medical attention when necessary (19). A recent 19 prospective pilot study of people self-managing medication abortion with online counselor support in 20 three countries found that 94% of participants reported a complete abortion without surgical intervention, 21 no adverse events were reported, and participants sought care after noticing symptoms of potential 22 complications (20). Based on safety and effectiveness data, WHO states that medication abortion can be 23 self-managed for pregnancies below 12 weeks gestation when individuals have access to a source of 24 accurate information and to a health care provider should they want or need one during the process (14). 25 Restrictions Imposed by the FDA 26 People who choose to self-manage their abortions with medication should have access to safe and 27 effective medications to do so. Despite the safety, effectiveness, and widespread use of mifepristone and 28 misoprostol, the FDA has imposed a series of drug safety restrictions on medication abortion, known as a 29 Risk Evaluation and Mitigation Strategy (REMS) (21). REMS are applied in rare cases: when a drug is 30 beneficial but carries the risk of serious side effects. As of 2017, only 74 of approximately 1750 FDA- 31 approved prescription drugs and therapeutic biologic active ingredients had REMS programs (17). While 32 evidence was limited when mifepristone was first approved in 2000, data has since shown an estimated 33 mortality rate of .00063% and a rate of nonfatal serious adverse events ranging from .01 to .7% (21).

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1 The mifepristone REMS requires that it be distributed by registered providers in clinics, hospitals, 2 and medical offices, which prevents individuals from being able to access the medication outside of a 3 clinic, like through pharmacies or the mail. Rather than improving safety, the REMS impedes access for 4 people who wish to self-manage abortion with this method by creating medically unnecessary barriers to 5 accessing mifepristone. Lawsuits challenging mifepristone’s REMS classification have noted that existing 6 FDA restrictions on mifepristone disproportionately affect lower income pregnant individuals and people 7 of color and exacerbate geographic barriers to accessing health care (22).The American College of 8 Obstetricians and Gynecologists (ACOG) has found that the mifepristone REMS are “outdated and 9 substantially limit access to this safe, effective medication” (23). Currently the FDA allows patients to 10 self-administer mifepristone at home, making the required in-person trip just to obtain the medication 11 burdensome and unnecessary (17). For self-managed abortion support services, this has created legal 12 challenges or, in some cases, entirely prevented these services from operating in the U.S. (24). 13 Self-Managed Abortion and Human Rights 14 Administrative and policy barriers to self-managed abortion violate international human rights 15 law. The Committee on Economic, Social, and Cultural Rights (CESCR) has stated that abortion must be 16 decriminalized, medicines for abortion must be made available, and that states must ensure that abortion 17 care is available, accessible, affordable, acceptable, and of good quality (25). They have further 18 recommended that states liberalize their abortion laws to improve access to safe abortion and remove 19 barriers that infringe upon the right to bodily autonomy, integrity, equality and non-discrimination as 20 relates to the full enjoyment of the right to sexual and reproductive health (25). Restrictions on 21 medication abortion, in particular, violate the right to benefit from scientific and technological progress. 22 As such, the CESCR recommends that states ensure access to up-to-date scientific technologies necessary 23 to fulfill the right to sexual and reproductive health, including access to medication for abortion (26). 24 Moreover, applying a reproductive justice lens to abortion illuminates that access to abortion care 25 is a critical aspect of a person’s life, autonomy, and dignity. The term “reproductive justice” was coined 26 by a group of U.S. Black women human rights activists and organizers in 1994 who saw that the needs of 27 communities of color were being ignored by pro-choice advocates. Reproductive justice refers to the 28 interconnected human rights “to maintain personal bodily autonomy, have children, not have children, 29 and parent the children we have in safe and sustainable communities” (27). Self-managed abortion lies at 30 the intersection of human rights, public health, autonomy, and access. Putting the tools for safe abortion 31 care into the hands of those who want them facilitates the realization of one’s right to bodily autonomy, to 32 control one’s own health care, and to self-determination. 33 A human rights and public health harm reduction approach requires efforts to ensure that 34 individuals do not face legal risks from self-managing abortion and that individuals who choose self-

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1 managed abortion are able to do so with access to accurate information, quality medicines, and support. 2 As clinical care for abortion becomes increasingly restricted and stigmatized in the U.S., more individuals 3 may turn to self-managed abortion. The new majority on the Supreme Court has also signaled a 4 willingness to roll back abortion rights, which may lead to more clinic closures and increased demand for 5 abortion outside the formal clinical setting. Evidence has indicated that even with onerous restrictions, 6 individuals have found ways to self-manage their abortions with medications and other methods (7). For 7 others, the combination of medically unnecessary state restrictions on clinic-based abortion care, such as 8 waiting periods, mandatory counseling, and gestational age bans, and the FDA REMS has placed both 9 clinical care and self-managed abortion with medication out of reach. Individuals barred from accessing 10 both forms of care face increased health risks from unsafe techniques for self-managing abortion or from 11 being forced to carry their pregnancy to term. Repealing and reforming laws that could be used to 12 criminalize people for self-managing abortion and removing medically unnecessary obstacles to self- 13 managed abortion are critical steps in respecting the right to bodily autonomy, ensuring access to the full 14 range of sexual and reproductive health care, and reducing inequities in access to abortion care. 15 IX. Evidence-based Strategies to Address the Problem 16 Creating a fully enabling environment for people to receive abortion care how they need and 17 prefer to receive it – without stigma or fear – will require decriminalizing all forms of self-managed 18 abortion, exploring and expanding global models for self-managed abortion information and support, de- 19 medicalizing in-clinic medication abortion, and adopting a comprehensive research agenda to generate 20 further evidence needed to support this care. 21 Decriminalizing Self-Managed Abortion at the State-Level 22 If/When/How: Lawyering for Reproductive Justice has developed a three-pronged approach to 23 state policy advocacy to enable pregnant people to self-manage their abortion and seek medical care 24 without fear of prosecution: Repeal, Reform, Reinforce. They work with allies to urge state policymakers 25 to repeal criminal laws targeting people who self-manage abortion, reform laws to prevent misuse by 26 prosecutors, and reinforce existing abortion rights protections to include freedom from criminalization. 27 For example, in 2018 and 2019 Massachusetts and New York, respectively, repealed archaic laws from 28 the 19th century that criminalized abortion. Also, it is crucial that clinicians, law enforcement, and 29 prosecutors understand actual legal requirements to prevent misuse. While no mandatory reporting rules 30 exist to report people that self-manage their abortion, administrative policies may be misinterpreted to 31 permit or require clinicians to report self-managed abortion, compromising trust between patients and 32 clinicians and undermining ethical and legal requirements to protect patient privacy (12). 33 Models for Delivering Self-Managed Abortion Information and Support Safely and Effectively

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1 WHO recommends that individuals have accurate information and access to a health care 2 provider should they need or want it at any stage of the self-managed abortion process (14). In response, 3 many community-driven and clinician-supported initiatives around the world exist to support safe self- 4 managed abortion with medications (mifepristone and misoprostol or misoprostol only), while promoting 5 human rights and autonomy over one’s health (28). 6 In countries where abortion care is heavily restricted, feminist collectives led by non-clinician 7 community experts have effectively implemented safe abortion hotlines to provide information, based on 8 WHO guidance, on how to use misoprostol (28). Similarly, accompaniment models for self-managed 9 abortion have expanded to communities where the legal right to abortion exists, but barriers impede 10 unfettered access to care. Accompaniment refers to trained grassroots volunteer networks providing 11 pregnant people with evidence-based counseling and support through the process. These models are 12 effective in supporting clients obtain the medications and complete their abortion without complications 13 or needing clinic-based care (20, 29). Studies have shown that trained, non-clinician volunteers in these 14 networks are capable of providing evidence-based support and information to clients (30). As these 15 models facilitate a culture of community - rather than clinical - experts who support, educate, and 16 accompany people self-managing their abortion, they work to tackle the challenges those most 17 marginalized face when navigating abortion care in restrictive, stigmatizing environments. 18 For those who want to self-manage with mifepristone and misoprostol, a myriad of national 19 organizations managed by clinicians and public health professionals also exist providing evidence-based 20 information online about the process, where to obtain pills, eligibility criteria, when to seek medical 21 attention, and legal advice. For example, Plan C provides up-to-date information on where to obtain pills 22 based off the state where one lives in the U.S. The Reproductive Health Access Project published “Sam’s 23 Medication Abortion,” a zine in English and Spanish that illustrates a person’s experience of a medication 24 abortion. Through the M+A hotline, physicians take individuals’ questions, direct them to resources, and 25 support them through the abortion process without directly providing pills. And, If/When/How’s free 26 confidential legal helpline answers legal questions for callers. 27 These services, too, face the threat of criminalization due to misapplied laws and anti-abortion 28 sentiment, making it harder to provide them. This may leave some to self-manage without the information 29 and support systems they need. Legal protections for those who self-manage and who provide a range of 30 support services for self-management are crucial to ensure people who self-manage their abortion have a 31 positive, safe, and dignified experience. 32 De-medicalization: Amending FDA Mifepristone REMS 33 Due to its safety, effectiveness, acceptability, and feasibility, expanding access to mifepristone 34 and misoprostol outside of the clinic setting is an essential first step to strengthening access to self-

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1 managed abortion. However, the FDA REMS requirements on mifepristone are inconsistent with its 2 safety profile and create barriers to health care not imposed on other medications. Other medications with 3 documented higher levels of risk (eg, anticoagulants and erectile dysfunction treatments) are not subjected 4 to REMS (21). REMS restrictions on mifepristone do not improve quality of care and only increase 5 barriers to and further stigmatize abortion care. Experts concur that mifepristone REMS is inconsistent 6 with the express rules governing how the FDA determines REMS classification. Its requirements should 7 not unduly burden either patient access or the health care system; yet mifepristone REMS does (21). 8 Without REMS, mifepristone could be provided via prescription in retail and online pharmacies without 9 unnecessary certification of health care providers, additional logistical and financial burdens on clinics 10 and patients, or requirements for patient consent not applied to other medications. Given mifepristone’s 11 safety data, its REMS classification should be revoked. 12 De-medicalization: Telemedicine for Self-Managed Abortion Care 13 Telemedicine for medication abortion has grown since the COVID-19 pandemic compelled 14 health care facilities to consider how to provide care with minimal interaction and travel. However, even 15 before the pandemic, clinician-staffed organizations like Women on Web and Aid Access have been 16 providing clients around the world with medication abortion care via telemedicine and/or online 17 consultation and sending medications by mail (8, 19). Data demonstrate that patients find their services 18 for at-home abortion acceptable and satisfactory (31). Safety and effectiveness outcomes are comparable 19 to that of in-clinic medication abortion care (19). In response to the COVID-19 pandemic, abortion care 20 experts have developed a “no-test” protocol for providing medication abortion and minimizing virus 21 exposure (32). This protocol emphasizes telemedicine and minimizes in-person, in-clinic tests that 22 researchers have found usually unnecessary for safe and effective medication abortion. 23 In July 2020, a federal court injunction temporarily suspended the REMS requirement of in- 24 person mifepristone dispensing during the pandemic public health emergency (though the Supreme Court 25 reversed this in January 2021) (22). During that time, many clinic-based abortion providers began 26 providing (and Aid Access continued providing) completely virtual, at-home medication abortion care, 27 including sending the medications by mail. 28 Ongoing Research Agenda 29 Further research would provide evidence to enable full support for and access to self-managed 30 abortion in the U.S. This research agenda must include an assessment of a) safety and effectiveness of all 31 forms of self-managed abortion, b) patients’ abilities to self-assess eligibility for using medications for 32 abortion (like reading a drug label) and to seek clinical guidance when necessary, c) safety and 33 effectiveness of self-managed abortion compared to in-clinic medication abortion in the U.S., d)

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1 experiences of U.S. patients self-managing their abortion through organizations like Plan C, M+A 2 Hotline, and Aid Access; and e) strategies to best get people the information and resources they need. 3 X. Opposing Arguments/Evidence 4 Opponents of self-managed abortion largely argue that moving abortion outside of the medical 5 setting, beyond a clinician’s direct supervision, would be unsafe for pregnant people. They highlight 6 arguments about the safety of self-managed abortion generally and whether patients are capable of 7 fulfilling the requirements to self-manage their abortion with medications. 8 Safety of Self-Managed Abortion 9 Before the 1970s, when Roe v. Wade legalized abortion in the U.S., pregnant people were often 10 compelled to pursue dangerous methods to terminate an unwanted pregnancy due to its illegality and 11 inaccessibility (11). Though the harms of “pre-Roe” clandestine abortions was of great public health 12 concern, applying the experiences of the past to 2021 and beyond ignores the plethora of safer and more 13 effective models for self-managed abortion that exist today. Decades of research prove that abortion with 14 medications is safe and effective and that serious complications are very rare (14, 16). Researchers have 15 also found that the quality of mifepristone and misoprostol obtained through online vendors without a 16 prescription is high and contains an appropriate and expected amount of the active ingredients (33). 17 The biggest risk to the safety of people self-managing their abortion is the threat of 18 criminalization and prosecution. This threat may result in negative health outcomes by eroding trust in the 19 medical system and deterring people from seeking care when they need it (12). Pregnant patients of color, 20 immigrants, and/or with lower incomes are more likely to be reported for suspected self-managed 21 abortion compared to patients who are white and/or affluent (10). Medical providers have no obligation to 22 report patients, and such reporting may violate state and federal medical privacy laws (34). 23 Ability to Fulfill Requirements to Self-Managing Abortion with Medications 24 Arguments against self-managed abortion also question the ability of pregnant people to self- 25 assess eligibility, to take the pills, and to self-assess for abortion completion. 26 Assessing eligibility refers to determining gestational age of the pregnancy and determining 27 contraindications, like having an intrauterine device, using anticoagulants, and several others. Ultrasound 28 is typically used for accurate and precise dating of pregnancies. However, last menstrual period (LMP) 29 can also be used to determine gestational age (35, 36). Several online and mobile applications exist to 30 assist patients, and even clinicians, calculate gestational age by entering one’s LMP. Some argue that 31 Rhesus factor (Rh) testing is necessary due to the risk of sensitization after early abortion if the fetus is 32 Rh positive when the pregnant person is Rh negative. However, evidence shows that this risk is 33 negligible; the National Abortion Federation (NAF) and ACOG state that Rh testing is not required and 34 should not be a barrier to receiving mifepristone and/or misoprostol (13, 37). Before and during the

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1 COVID-19 pandemic, many U.S. abortion providers did not require these tests due “no-test” abortion 2 protocols to minimize interpersonal contact and unnecessary travel (32). 3 Determining mifepristone and misoprostol contraindications can be easily completed by a patient 4 on their own through simple, low-literacy drug labels and checklists (38, 39). For example, researchers 5 have shown that women with some literacy who have never had nor assisted someone with medication 6 abortion are able to read a sample label and comprehend when the drugs are indicated and know when to 7 consult a clinician before use (39). 8 Some are concerned with the risks of ectopic pregnancy, which occur when a fertilized ovum 9 implants outside of the uterine cavity. They occur in approximately 1-2% of pregnant women in the 10 general population, though in less than 1% of those seeking abortion care (40, 41). An undiagnosed 11 ectopic can rupture and cause life-threatening bleeding. Mifepristone and/or misoprostol will not 12 terminate an ectopic, allowing it to potentially go undiagnosed. Clinicians screen for potential ectopic 13 pregnancy pre-abortion by asking about lower abdominal pain, vaginal bleeding, history of ectopic, or 14 risk factors (13). For those without ectopic risk factors, ultrasound is often not necessary (13). Low- 15 literacy drug labels, checklists, and advice from self-managed abortion groups on ectopic pregnancy risk 16 and symptoms can enhance safety and ensure that those at risk get the care they need (38, 39). 17 Taking the medication correctly without clinician supervision has precedent from the FDA- 18 approved medication abortion regimen. Prior to 2016, the FDA-approved regimen required patients to 19 make multiple visits to their clinician to administer mifepristone and misoprostol, rather than doing so at 20 home (17). Numerous studies found that home administration was as safe, effective, and acceptable to 21 patients as clinic administration (42, 43). In 2016, the FDA changed their regimen to recognize the safety, 22 effectiveness, and feasibility of home administration. Just as patients follow their clinician’s instructions 23 regarding dosage, intake, and timing, they are able to follow these same directions by reading evidence- 24 based and reputable instructions, labels, and other patient education resources offering information on 25 how to self-manage abortion (39). 26 Lastly, opponents may argue that follow-up clinical care is necessary to determine whether the 27 abortion was completed. However, patients are able to self-assess abortion completion and to determine 28 whether or not they need follow-up care by using symptom evaluation and a urine pregnancy test found at 29 drug stores (19, 44, 45). A decline in human chorionic gonadotropin concentration in urine as indicated 30 by a pregnancy test is a highly accurate and inexpensive way to determine, at home, whether there is an 31 ongoing pregnancy (46). 32 Overall, self-managed abortion with medications is safe and has similar outcomes to medication 33 abortion in health facilities (19, 47-49). To supplement individuals’ own abilities to fulfill the 34 aforementioned criteria, easily accessible support networks, hotlines, and groups staffed by clinicians

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1 and/or community experts exist to help people manage their abortion at any stage in the process. These 2 systems are a key component of ensuring a safe, effective, and positive self-managed abortion experience. 3 XI. Alternative Strategies 4 There are no evidence-based counterpoints to our knowledge. 5 XII. Action Steps 6 1. APHA calls on elected officials to repeal all laws that criminalize any form of self-managed 7 abortion, including laws criminalizing feticide and others that may be misused. Lawmakers or 8 attorneys general must ensure that any laws criminalizing harm to fetuses do not apply to acts or 9 omissions with respect to one’s pregnancy. Elected officials must reform laws to prevent misuse 10 by prosecutors and reinforce existing protections for abortion rights to include freedom from 11 criminalization for those who self-manage and provide self-management information and support. 12 2. APHA calls on professional medical organizations, medical schools, residency programs, and 13 nursing schools to provide pre-service education to ensure health care providers know how to 14 care for someone experiencing abortion or complications in ways that are 15 compassionate, trauma-informed, and will not lead to punishment. 16 3. APHA calls on public health agencies, medical professional organizations, and health care staff to 17 engage in continuous education, training, and dialogue about medical, ethical, and legal 18 obligations to provide supportive counseling and emergency post-abortion care with compassion, 19 dignity, and respect and to uphold patients’ privacy and confidentiality as asserted in state and 20 federal medical privacy laws. 21 4. APHA encourages public health professionals to study, develop, promote, and expand models of 22 providing self-managed abortion support, information, accompaniment, and care. 23 5. APHA calls on elected officials and the FDA to remove the REMS requirements for mifepristone. 24 6. APHA calls on members, medical organizations, public health officials, researchers, and 25 manufacturers of mifepristone and misoprostol to work on applying to the FDA for over-the- 26 counter status. 27 7. To ensure individuals have true choice between self-managed and clinic-based abortion care, 28 APHA calls on federal- and state-level elected officials to pass legislation to guarantee and 29 expand access to in-clinic abortion care. This includes repealing medically-unnecessary and non- 30 evidence based abortion restrictions, repealing bans on telemedicine for abortion care, passing 31 legislation at the federal level to strengthen and expand the constitutional right to abortion, and 32 repealing the Hyde Amendment. 33 8. APHA calls on public health researchers to pursue a self-managed abortion research agenda to 34 generate evidence to enable the full support for and access to self-managed abortion in the U.S.

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1 XIII. References

2 1. Nash E. Unprecedented wave of abortion bans is an urgent call to action. Available at: 3 guttmacher.org/article/2019/05/unprecedented-wave-abortion-bans-urgent-call-action. Accessed January 4 26, 2021.

5 2. Hall KS, Redd S, Narasimhan S, Mosley EA, Hartwig SA, Lemon E, Berry E, Lathrop E, Haddad LB, 6 Rochat R, Cwiak C. Abortion trends in Georgia following enactment of the 22-week gestational age limit, 7 2007-2017. Am J Public Health. 2020; 110: 1034-1038.

8 3. Norris AH, Chakraborty P, Lang K, Hood RB, Hayford SR, Keder L, Bessett D, Smith MH, Hill BJ, 9 Broscoe M, Norwood C, McGowan ML. Abortion access in Ohio's changing legislative context, 2010- 10 2018. Am J Public Health. 2020; 110: 1228-1234.

11 4. American College of Obstetricians and Gynecology. Increasing Access to Abortion: Committee 12 Opinion Number 815. Available at: https://www.acog.org/clinical/clinical-guidance/committee- 13 opinion/articles/2020/12/increasing-access-to-abortion. Accessed January 26, 2021.

14 5. White K, Baum SE, Hopkins K, Potter JS, Grossman D. Change in second-trimester abortion after 15 implementation of a restrictive state law. Obstet Gynecol. 2019; 133(4): 771-779.

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