Abstract
Objective
Protocols including mifepristone are the most effective medication regimens for medication abortion and early pregnancy loss (EPL) management. Both can be safely and effectively offered in primary care settings. Despite mifepristone's excellent safety record, the United States (US) Food and Drug Administration (FDA) heavily regulates provision. This exploratory study examines US primary care clinicians’ perspectives on the effects of mifepristone restrictions, including FDA regulations, on access to medication abortion and EPL management in primary care.
Study Design
In 2019, we conducted an online qualitative survey of US primary care clinicians recruited from six reproductive health-focused listservs. Open-ended questions queried about barriers to providing mifepristone and effects on patients when unable to access mifepristone in primary care. We iteratively coded and analyzed qualitative data using inductive thematic analysis.
Results
Of our analytic sample of 113 respondents, one-third had mifepristone available in their current primary practice setting. Key barriers to provision stemmed from the FDA rule to stock and dispense mifepristone onsite, including logistical difficulties and resistance from health center leadership. Clinicians believed that lack of mifepristone in primary care resulted in negative patient experiences, including disrupted continuity of care, medically-unnecessary appointments, and undesired aspiration procedures.
Conclusions
FDA regulations that inhibit mifepristone provision in primary care create structural barriers to provision. This may result in physical, emotional, and financial burdens for patients.
Implications
When mifepristone is unavailable in primary care, some patients in need of abortion or EPL care may experience physical, emotional, and financial harms. Removing FDA restrictions is a critical step in reducing primary care barriers to mifepristone provision and improving access to timely, patient-centered medication abortion and EPL care.
Keywords
1. Introduction
Abortion and early pregnancy loss (EPL) are very common. In the United States (US), one in four women will have an abortion in their lifetime; one in five will have a clinically-recognized EPL [
1
, 2
]. Using mifepristone with misoprostol for medication abortion is safe and effective [3
, 4
, 5
]. Mifepristone with misoprostol is recommended by professional medical organizations to treat EPL off-label, as it is the most effective medication regimen (83.8% vs 67.1% misoprostol-only) [5
, 6
, 7
]. To date, abortion is the only US Food and Drug Administration (FDA)-approved indication for mifepristone.The FDA has long restricted mifepristone under a Risk Evaluation and Mitigation Strategy (REMS), a drug safety program designed to regulate medications suspected to cause serious adverse effects [
[8]
]. Yet, among 3.7 million US people who have taken mifepristone since 2000, the FDA reported 24 deaths, of which several were unrelated to the drug. Between 2012 and 2018, the FDA reported 1,455 adverse events, including 274 people requiring hospitalization and 12 severe infections [[9]
]. The mifepristone REMS includes three Elements to Assure Safe Use (ETASU): (1) mifepristone cannot be mailed or dispensed in pharmacies, only stocked and provided to patients in medical offices; (2) a clinician with prescriptive authority must become certified through a prescriber agreement; and (3) patients must sign an FDA-approved agreement. All elements apply even for off-label indications, like EPL [United States Food and Drug Administration. Mifepristone US post-marketing adverse events summary through 12/31/2018, https://www.fda.gov/media/112118/download; 2019 [accessed 20 November 2020].
[10]
].United States Food and Drug Administration. Risk Evaluation and Mitigation Strategy (REMS) single shared system for Mifepristone 200mg. https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Document.pdf; 2019. [accessed 20 November 2020].
Providing abortion and EPL care in primary care settings is feasible and acceptable to patients, and enhances continuity of care [
[4]
,[11]
]. Some patients report a preference for getting this care from their primary care practice, while others prefer receiving abortion care at freestanding clinics [[12]
,[13]
]. Providing mifepristone in primary care may also increase access to abortion care [[14]
]. Despite feasibility, acceptability, and need, only about 25% of primary care physicians trained in reproductive health provide medication abortion and/or comprehensive EPL care. Of these, about half offer medication abortion and medication management of EPL in specialized settings, respectively, rather than in primary care [15
, 16
, 17
, 18
].Barriers to integrating mifepristone into primary care include staffing, limited time, training, stigma, malpractice insurance, and federal and state laws [
15
, 16
, 17
, 18
, 19
]. The Hyde Amendment, for example, prohibits using federal funds for abortion except in cases of rape, incest, and serious health consequences for or life endangerment of the pregnant person [[20]
]. Additionally, states continue to enact laws imposing non-evidence-based conditions on patients and clinicians, like mandatory ultrasounds, waiting periods, and “physician-only” care, which contribute to delays, stigma, and medically-unnecessary visits and procedures [American Civil Liberties Union. Access denied: origins of the Hyde Amendment and other restrictions on public funding for abortion, https://www.aclu.org/other/access-denied-origins-hyde-amendment-and-other-restrictions-public-funding-abortion. [accessed 20 November 2020].
[21]
,Nash E, Mohammed L, Cappello O, Naide S. State policy trends 2019: a wave of abortion bans, but some states are fighting back, https://www.guttmacher.org/article/2019/12/state-policy-trends-2019-wave-abortion-bans-some-states-are-fighting-back; 2019. [accessed 20 November 2020].
[22]
]. While research has explored the effects of these laws on abortion access and outcomes, none to date have studied the effect of mifepristone ETASU on the delivery of medication abortion and EPL management in primary care. This exploratory study examines primary care clinicians’ perspectives on the ways that regulations, specifically the REMS, affect access to medication abortion and EPL care in primary care settings.2. Material and methods
From September to December 2019, we conducted a qualitative survey with open- and closed-ended questions with a convenience sample of US primary care clinicians. To recruit participants, we identified primary care reproductive health-focused listservs managed by professional medical and/or reproductive health organizations. From an initial list of 10 listservs, we selected 6 based on the following criteria: supports abortion care, moderator accepts postings for research, and represents a predominantly primary care clinician audience. The 6 listservs represented family medicine (n = 1), advanced practice nurses (APRNs) [nurse practitioners (NPs) and midwives, n = 3], adolescent medicine (n = 1), and internal medicine (n = 1). Five listservs ranged from 180 to 275 members; one had 3,200 members. Listserv membership was not mutually exclusive.
The Institutional Review Board of the Institute for Family Health deemed the study exempt from full board review.
2.1 Data collection
Moderators (n = 5) or the study team (n = 1) shared survey invitations and reminders to listservs. We invited primary care clinicians to share thoughts about whether and how restrictions on mifepristone affected their abilities to provide medication abortion and/or EPL care. We sent up to 3 reminders every 2 to 3 weeks. Each listserv received a unique URL for response tracking. As an incentive, respondents could enter a raffle for one free registration to a conference on family planning and abortion care.
Additionally, we employed early participant referral. Within each invitation and reminder, and upon survey completion, respondents could share a unique link to colleagues they felt would be interested in participating. We closed the survey 2 weeks after the last reminder.
2.2 Survey instrument and sample
Prior studies and discussions with experts informed survey development [
[23]
]. We pretested the survey with family physicians and NPs. The final version included closed-ended questions on demographic and practice characteristics, and knowledge and perceptions of mifepristone and hypothetical pharmacy dispensing. We paired the latter with open-ended questions asking for respondents to elaborate on their perceptions of effects of mifepristone stocking and dispensing ETASU; attitudes toward mifepristone pharmacy-dispensing; and willingness to complete the prescriber agreement. We also asked participants the following: “tell us about the challenges you have perceived, observed, or faced when thinking about or actually trying to provide mifepristone in clinical practice.” We prompted respondents to share how challenges affected patients. This question did not explicitly mention the REMS to allow respondents to share any challenges that arose.The survey included two screener questions to assess eligibility: respondents had to identify as primary care clinicians and have seen reproductive-aged female patients within the last 5 years in the US. We included participants who answered at least one open-ended question. We excluded those who primarily provided in abortion clinics and those with missing data. We de-identified and stored data in a password-protected Dropbox folder.
2.3 Analysis
We used summary statistics to describe the sample and perceptions of mifepristone regulations. We employed inductive thematic analysis to analyze barriers to providing mifepristone in primary care and respondents’ perspectives of patient experiences [
[24]
]. The analysis team consisted of five women with experience in qualitative data analysis: a public health researcher (SS), a family physician and reproductive health services researcher (SR), a family physician receiving advanced training in reproductive healthcare and advocacy (JM), and 2 family medicine residents (RY, LB).Initially, the team independently read responses and used open coding to identify emerging themes and constructs. After discussion, we adapted Bronfenbrenner's socioecological model to develop codes based on emerging barriers and patient experiences [
[25]
]. SS and SR developed an initial codebook with 14 codes and definitions. After re-reading 20 respondents’ survey text, we reviewed coding for concordance and refined the codebook accordingly. Then, 2 team members independently read every respondents’ survey text and applied the final codebook, which contained 19 codes. SS coded all text; one of four clinicians each employed axial coding to 25 to 32 respondents’ text to make connections between constructs and to begin developing an integrated theory. We reconciled discordance through discussion. The analysis team then discussed the coded excerpts and their intersections to identify themes and organized them into matrices for in-depth analysis. Throughout, we wrote memos to practice reflexivity, acknowledging our biases as reproductive health professionals and/or clinicians [[26]
]. We utilized Dedoose version 8.3.10 (Los Angeles, CA: SocioCultural Research Consultants, LLC) to manage data.3. Results
Of the 172 people who took the survey, 16 screened ineligible, 12 left the survey incomplete, 5 primarily practiced in abortion clinics, and 26 did not complete any open-ended questions, leaving an analytic sample of 113 respondents (66%). Table 1 illustrates participants’ demographic characteristics and knowledge and perceptions around mifepristone regulations. Most respondents were family physicians, women, practiced in federally qualified health centers (FQHCs) and urban areas, and supported pharmacy dispensing of prescription mifepristone.
Table 1Primary care clinician respondents’ demographic and practice characteristics, and knowledge and perceptions around mifepristone regulations (N = 113).
| Demographic characteristics | n (%) |
|---|---|
| Professional background | |
| Family physician | 67 (59%) |
| Midwife | 17 (15%) |
| Nurse practitioner or physician assistant | 12 (11%) |
| Other physician type* | 9 (8%) |
| No response | 8 (7%) |
| Gender | |
| Female | 95 (84%) |
| Male | 8 (7%) |
| Non-binary | 1 (0.9%) |
| No rresponse | 9 (8%) |
| Abortion rights hostility of respondent's state** | |
| Very supportive | 15 (13%) |
| Supportive | 24 (21%) |
| Leans supportive | 19 (17%) |
| Middle ground | 20 (18%) |
| Leans hostile | 6 (5%) |
| Hostile or very hostile | 19 (17%) |
| No response | 10 (9%) |
| Practice characteristics | |
| Ever provided... | |
| Medication abortion | 75 (66%) |
| EPL with misoprostol | 82 (73%) |
| EPL with mifepristone & misoprostol | 40 (35%) |
| Never provided abortion or medication management of EPL | 13 (12%) |
| Self-reported competence to provide | |
| Medication abortion | 101 (89%) |
| EPL with misoprostol | 104 (92%) |
| EPL with mifepristone & misoprostol | 95 (84%) |
| Practice setting characteristics | |
| Mifepristone available onsite at current main practice setting | 36 (32%) |
| Main practice setting | |
| Federally qualified health center | 36 (32%) |
| Hospital-affiliated outpatient clinic | 23 (20%) |
| University faculty practice | 17 (15%) |
| Community health center | 7 (6%) |
| Group private practice | 8 (7%) |
| Other practice settings*** | 11 (10%) |
| No response | 11 (10%) |
| Urbanicity of main practice setting | |
| Urban | 65 (58%) |
| Midsize town/suburb | 24 (21%) |
| Rural | 14 (12%) |
| No response | 10 (9%) |
| Knowledge and perceptions around mifepristone regulations | |
| Knew prior to survey that mifepristone and misoprostol for EPL is more effective than misoprostol alone | 101 (89%) |
| If allowed to prescribe mifepristone, would prescribe for... | |
| Medication abortion | 85 (75%) |
| Medication management of EPL | 103 (91%) |
| Strongly agree patients should be able to fill a mifepristone prescription at their pharmacy | 106 (94%) |
| Believes rule to stock and dispense in-clinic interferes with mifepristone provision | 83 (74%) |
*Other physician types include adolescent medicine pediatricians, internal medicine physicians, obstetrician-gynecologists who work in primary care settings.
**Abortion rights hostility level of respondents’ primary practice state refers to the 2019 data presented by the Alan Guttmacher Institute that categorizes states on a scale of very supportive to very hostile based on the number of state-level abortion restrictions in place (very hostile, hostile, leans hostile, middle-ground, leans supportive, supportive, very supportive).
[27]
Few respondent states were considered “very hostile” so we collapsed them with “hostile.” We selected 2019 data to convey the abortion rights hostility of respondents’ states at the time data were collected.***Respondents classified into “other” primary practice settings provided care in health maintenance organizations, solo private practices, urgent care, public health departments, and the Indian Health Service.
3.1 Barriers to provide mifepristone in primary care
Obstacles to providing mifepristone centered on the REMS-related organizational barriers to stock and dispense and the intersection of the REMS with other abortion policy issues.
For organizational barriers, two REMS-related obstacles emerged regarding stocking and dispensing mifepristone: bureaucratic hurdles and leadership resistance. Bureaucratic hurdles involved logistical challenges, like “upfront cost[s]... training staff… [and] extra time,” to establish supply, clinic, and patient care systems (NP, hospital-affiliated outpatient clinic). Some found the process more complicated than obtaining equipment for uterine aspiration. They remarked that often primary care settings “do not have the infrastructure or space” to routinely stock and dispense prescription medications (Physician, FQHC).
Additionally, various clinic and department managers, administrators, and others in positions of power demonstrated misperceptions, resistance, and discomfort to integrate medication abortion and/or mifepristone for EPL management. This administrative resistance inhibited respondents from pursuing efforts to change practice and provide mifepristone. One respondent described:
We have tried to get mifepristone available at all of our clinic sites, and the pharmacy department has been very resistant and difficult to work with on this due to the REMS classification. They state that they are scared about being out of compliance and risking shutting down the entire institution. They demonstrate many false ideas about what the REMS classification does and does not mean, but are unwilling to change their opinions or practices about this. (Physician, FQHC).
Overall, respondents believed that bureaucratic barriers would be minimized if mifepristone was available by prescription, rather than stocked onsite.
Some shared how the REMS intersects with federal and state abortion restrictions, like the Hyde Amendment and physician-only laws. Many FQHC respondents said their organizations barred abortion care, including stocking and dispensing mifepristone, due to administrators’ risk aversion and misinterpretation of the law. One explained:
Our directors and managers believe that it's illegal for us to provide pregnancy terminations. The reality is we would have to separate out federal funding from other funding sources. Our financial department is not that savvy, nor are they interested in setting up a parallel system of funds. (Physician, FQHC).
Even for EPL care, FQHC leadership prevented clinicians from using mifepristone due to its association with abortion and perceived similarities between abortion and EPL care: “They [administration] feel it could jeopardize funding even though we would only use it for EPL” (Physician, FQHC).
In many states, physician-only laws prohibit APRNs and physician assistants from providing abortion care. One respondent described:
I was able to provide mifepristone in my practice…until the state laws changed and restricted provision of abortion services to physicians only… We had to wait for a physician to travel 3.5 hours to our clinic twice a month. So, all patients who needed abortion services had to come on specific days, when they were previously able to come any day. (Midwife, community health center).
Though these laws were designed to impact abortion, respondents shared that they affected EPL care too.
3.2 Effects of restricted mifepristone access on patients
Respondents perceived three kinds of patient harms when mifepristone was inaccessible in primary care: disrupted continuity of care, additional medically-unnecessary appointments, and undesired aspiration procedures for EPL.
Respondents felt that not having mifepristone accessible in primary care disrupted patients’ continuity of care. They described having close relationships with patients who preferred not to go to unfamiliar providers for abortion or EPL, as this may increase anxiety. One explained:
Patients have come to me wanting medical management of miscarriage or medical abortion, and I have had to turn them away and send them to other practices... stigmatizing their experience, and sending the message that management of their pregnancy and fertility is not part of primary care... I remember a patient sitting in my office, wanting a medical abortion from her trusted midwives and saying, how is it possible you can't provide me with this service? (Midwife, hospital-affiliated outpatient clinic).
Additionally, patients referred to outside facilities experienced added wait times and logistical issues, leading to delays in care and disproportionate financial burdens. A respondent said:
My patient was Spanish-speaking only and lived...45 minutes [from] the closest [abortion clinic]. I am a Spanish-speaking provider in her neighborhood. The patient had to pay for a second visit with [the abortion clinic] for a service I could have provided myself, and had to wait an additional two weeks for this appointment… It is anxiety-provoking for patients to go to an unfamiliar clinic at a distance from their home to see an unfamiliar provider who may not speak their native language. (Physician, FQHC).
Respondents also felt the ETASU to dispense mifepristone in-office created medically-unnecessary appointment-related obstacles for patients to navigate, delaying care and/or influencing decision-making. One shared:
Sometimes, I diagnose miscarriage when a patient is not in the office. If she wants to be treated with the mifepristone/misoprostol combination, then she must come into the clinic and wait until I (or another provider who feels comfortable dispensing mife[pristone]) is in session at the clinic. (Physician, FQHC).
In some cases, patients wanted medication management for their EPL but ultimately had undesired aspiration procedures due to lack of mifepristone in primary care:
I had a recent patient who chose aspiration due to greater effectiveness compared to misoprostol alone, but I think otherwise would have chosen medication management. She ultimately had a traumatic and painful procedure due to difficult anatomy...and I think would have been much better served with evidence-based medication management. (Physician, university practice).
In other situations, patients took the misoprostol-only regimen and needed follow-up aspirations, which may have been avoided had mifepristone been accessible in primary care:
I had two patients with EPL who wanted to pass the pregnancy at home, in private. Both felt this would help them process the [miscarriage] in a way that was best for them. Both failed protocols with misoprostol alone, and both required referral out to another clinic for manual vacuum aspiration. This took more time, was more expensive, and involved...meeting a provider with whom they were less comfortable. (Physician, FQHC).
Overall, respondents felt that primary care access to mifepristone could have prevented negative patient experiences.
4. Discussion
Even for clinicians committed to reproductive healthcare access, the FDA REMS rule mandating in-office mifepristone stocking and dispensing inhibited many from integrating medication abortion and/or EPL management into primary care. Respondents reported concerns that this resulted in negative physical, emotional, and financial experiences for patients. Studies exploring abortion restrictions find similar consequences: delays in care leading to large expenses, appointment and travel logistics to navigate, and emotional frustrations [
[22]
,[28]
]. For EPL, respondents cited an inability to honor patients’ preferences for treatment, which minimized decision-making autonomy and exacerbated potential harms to health and wellbeing. This is a significant public health concern, as evidence shows quality of life outcomes improve when patients have comprehensive EPL options available and they actively participate in treatment decisions [[29]
].These barriers to primary care access and negative patient experiences underscore the importance of removing mifepristone from the REMS. Delays due to the REMS do not enhance safety, timely care does. In fact, Canada has made pharmacy dispensing of mifepristone available, with positive experiences and improved access to care [
[30]
]. Expert opinion and safety data demonstrate that mifepristone no longer meets requirements to be regulated under a REMS [[4]
,[8]
]. Our findings suggest that amending the stocking and dispensing ETASU may ameliorate barriers to providing mifepristone in primary care.However, expanding primary care provision of mifepristone is complex. Even if the mifepristone REMS were removed, policies like the Hyde Amendment and physician-only laws will continue to restrict funding for and access to medication abortion. Some healthcare organizations may continue inhibiting mifepristone for EPL, due to associations with abortion [
[19]
]. Though mifepristone may not be fully accessible to all without repealing harmful federal and state laws, removing the mifepristone REMS is a crucial evidence-based step to increase access [[31]
]. While the mifepristone REMS persists, reproductive health and rights organizations should support interested primary care clinicians and health centers to obtain and provide mifepristone. Technical assistance and interprofessional training have shown to be effective in supporting committed primary care clinicians engage with leaders and colleagues to overcome logistical barriers and leadership resistance to offer abortion and EPL care [[15]
,[18]
,[19]
,[32]
,[33]
.- Calloway Danielle
- Stulberg Debra B.
- Janiak Elizabeth
Mifepristone restrictions and primary care: breaking the cycle of stigma through a learning collaborative model in the United States.
Contraception. 2021; (In this issue)https://doi.org/10.1016/j.contraception.2021.04.002
Our study has several limitations. While we approximated potential respondents from the chosen listservs, the true size and representativeness of the eligible source population is unknown due to lack of non-respondent eligibility information, possibility that emails were never opened, and potential overlap of membership across listservs. Additionally, this sample was not representative of the US primary care clinician workforce as most respondents have provided medication abortion at some point, are knowledgeable about medication abortion and EPL care, and have demonstrated interest in providing this care. As such, barriers may be different for clinicians less actively involved. As an exploratory qualitative study, we cannot make claims about representativeness or generalizability. We hoped early participant referral would increase our reach, but few respondents were sourced this way (n = 3). Patient experiences are described from clinicians’ perspectives, rather than patients themselves. We chose to collect qualitative data through open-ended survey questions, rather than in-depth interviews or focus group discussions. This allowed for a larger sample, which increased geographic, practice setting, and clinician diversity, though interviews and focus group discussions may have given us more insight and context. Finally, the study predated the COVID-19 pandemic, so we did not document practice changes or additional barriers.
Our exploratory study suggests that amending the mifepristone REMS may reduce barriers for clinicians interested in offering medication abortion and EPL management in primary care. Decades of prior research demonstrating mifepristone's safety combined with further studies on primary care barriers to access and patient outcomes can inform evidence-based FDA policy changes. The mifepristone REMS, intended to promote safety, should not concurrently inhibit patients from accessing standard of care treatment and must be reevaluated.
Declaration of Competing Interest
None.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sector.
Acknowledgments
The authors have no financial conflicts of interest to report. We are grateful for the willingness of listserv moderators to share our survey to their membership. We deeply appreciate Dr. Jiana Menendez's support with data analysis and the generous guidance from Kelly Cleland, Dr. Daniel Davis, Dr. Samantha Garbers, and Lisa Maldonado.
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Article info
Publication history
Published online: April 24, 2021
Accepted:
April 19,
2021
Received in revised form:
April 15,
2021
Received:
November 23,
2020
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© 2021 The Authors. Published by Elsevier Inc.
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