Abstract
Objective
To assess abortion patients’ perspectives about a hypothetical option to access medication abortion over the counter without a prescription.
Study design
From October 2019 to March 2020, people ages 15 and over seeking abortion at 7 facilities across the United States completed a cross-sectional, self-administered survey regarding their personal interest in and general support for accessing medication abortion over the counter, including the advantages and disadvantages of over-the-counter access. We used multivariable logistic regression with generalized estimating equations to assess associations between experiencing barriers that led to delay in obtaining abortion care and personal interest in and general support for accessing medication abortion over the counter.
Results
Of the 1687 people approached, 1202 (71%) wanted to participate, and 1178 completed the survey. Most people were personally interested in (725/1119, 65%) and in favor of (925/1120, 83%) over-the-counter medication abortion. The most common advantages noted of the over-the-counter model included privacy (772/1124, 69%), earlier access (774/1124, 69%), and convenience (733/1124, 65%). The most common disadvantages noted included incorrect use (664/1124, 59%), not seeing a clinician beforehand (439/1124, 39%), and could be less effective (271/1124, 24%). In adjusted analyses, cost barriers that resulted in delays to the appointment, White race/ethnicity (vs Black), and higher educational attainment were significantly associated with greater personal interest in and support for over-the-counter medication abortion.
Conclusions
People accessing facility-based abortion care are very supportive of and interested in being able to access abortion over the counter. Those facing financial barriers obtaining facility-based care may benefit from allowing medication abortion to be available over the counter without a prescription.
Implications
Given people's interest in over-the-counter access to medication abortion, research is needed to assess whether people can use medication abortion appropriately without clinical supervision. Such research could help determine whether medication abortion is suitable for an over-the counter switch.
1. Introduction
While the United States (U.S.) Food and Drug Administration recently eliminated the in-person dispensing requirement for mifepristone, the first drug used in the mifepristone/misoprostol medication abortion regimen, they still require a prescription by a certified healthcare professional who meets certain qualifications, and people living in states that restrict telemedicine continue to be unable to access medication abortion by mail [
[1]U.S. Food and Drug Administration. Mifeprex (mifepristone) Information 2021.
]. This prescribing requirement is in place despite mifepristone's demonstrated safety, low toxicity profile, low potential for abuse [
2U.S. Food and Drug Administration. Mifeprex (mifepristone) information. Postmarket drug safety information for patients and providers; 2016. 2016.
,
3- Abubeker FA
- Lavelanet A
- Rodriquez MI
- Kim C.
Medical termination for pregnancy in early first trimester (≤ 63 days) using combination of mifepristone and misoprostol or misoprostol alone: a systematic review.
,
4- Kapp N
- Grossman D
- Jackson E
- Castleman L
- Brahmi D
A research agenda for moving early medical pregnancy termination over the counter.
], and even though people usually manage the entire abortion process on their own at home. Understanding people's interest in accessing medication abortion over the counter can help to demonstrate demand for an over-the-counter medication abortion product in the U.S., as well as to motivate the relevant stakeholders to conduct the necessary research to assess whether an over-the-counter switch for medication abortion is warranted.
However, there is limited evidence in the U.S. regarding people's interest in de-medicalized models of abortion care including accessing medication abortion over the counter. In 2017, findings from a national probability-based survey of people who self-identified as women demonstrated that 37% supported and 23% were personally interested in accessing medication abortion over-the-counter, noting its privacy and convenience, although people also noted concerns [
[5]- Biggs MA
- Ralph L
- Raifman S
- Foster DG
- Grossman D.
Support for and interest in alternative models of medication abortion provision among a national probability sample of U.S. women.
]. For example, among other concerns, people noted that women might take the pills incorrectly. Similarly, research with people accessing medication abortion through an online telemedicine service, where people receive the medication abortion pills by mail, along with online support and guidance from a clinician, indicated that users prefer the privacy and convenience of the telemedicine model [
[6]- Aiken ARA
- Starling JE
- Gomperts R
- Tec M
- Scott JG
- Aiken CE.
Demand for self-managed online telemedicine abortion in the United States during the coronavirus disease 2019 (COVID-19) pandemic.
,
[7]- Aiken ARA
- Broussard K
- Johnson DM
- Padron E.
Motivations and experiences of people seeking medication abortion online in the United States.
. The current study expands on previous research by gauging interest in an over-the-counter medication abortion model among people in the U.S. who might be most interested in this model: people accessing abortion.
3. Results
Of the 1687 people approached, 1202 were interested and eligible (71% response rate), 1178 started the survey, and 1124 responded to one or both outcome variables, which came at the end of the survey. Participant characteristics and people's personal interest in and support for an over-the-counter medication abortion option are presented in
Tables 1 and
2, respectively. Most people indicated probable (253/1119, 23%) or definite (472/1119, 42%) personal interest in and being in favor (761/1120, 68%) or somewhat in favor (164/1120, 15%) of other women being able to buy abortion pills over the counter (
Table 3). The most common advantages selected included privacy (772/1124, 69%), being able to end the pregnancy earlier (774/1124, 69%), and convenience (733/1124, 65%). The most common disadvantages selected included concerns that people might take the pills incorrectly (664/1124, 59%), not seeing a clinician (439/1124, 39%), could be less effective (271/1124, 24%) and someone could find the pills at home (267/1124, 24%). Five percent (59/1124) of participants indicated that the over-the-counter model had no advantages whereas 12% (136/1124) indicated that it had no disadvantages.
Table 1Characteristics of abortion patients enrolled in the pregnancy duration study (N = 1124)
Table 2Interest and support for an over-the-counter medication abortion option among U.S. abortion patients enrolled in the pregnancy duration study (N = 1124)
Table 3Advantages and disadvantages of an over-the-counter medication abortion option selected by U.S. abortion patients enrolled in the pregnancy duration study (N = 1124)
Note: People could indicate one or more advantage or disadvantage.
In adjusted analyses, having experienced a financial barrier that led to delayed care was significantly associated with greater odds of having a personal interest in [adjusted Odds Ratio (aOR, 1.45, 95% Confidence Interval (CI), 1.06, 2.00] and being in favor of an over-the-counter option (aOR, 1.68, 95% CI, 1.09, 2.61) (
Table 4). Personal interest in and support for an over-the-counter option was also significantly higher among non-Hispanic White respondents as compared to Black/African American respondents, and higher among people with a college degree than among those with a high school diploma or equivalent. People who indicated an “other” race/ethnicity that did not fit into our primary categories had significantly higher odds of expressing interest in (aOR, 1.82, 95% CI, 1.02, 3.25), but not support for, over-the-counter access than those who identified as Black/African American. When compared to people ages 20 to 24, people ages 30 or older had reduced odds of support for over-the-counter access (aOR, 0.52, 95% CI, 0.31, 0.88) but age was not significantly associated with personal interest in over-the-counter access. Employment status, experiencing food insecurity, pregnancy duration, parity, history of abortion and living in a state with a hostile policy environment were not significantly associated with either outcome.
Table 4Proportions and adjusted odds ratios (aOR) of interest and support for medication abortion (MAB) being available over the counter without a prescription by participant characteristics.
aOR=Adjusted Odds Ratio; Ref.= Reference group; Statistically significant differences (p<.05) are presented in bolded text; All variables were included in the same model
Box 1Over-the-counter medication abortion provision model
4. Discussion
This study assessed U.S. abortion patients’ interest in and support for accessing medication abortion over the counter. We find high levels of support for the over-the-counter model presented (83%), markedly higher than the 37% previously reported among a nationally representative survey [
[5]- Biggs MA
- Ralph L
- Raifman S
- Foster DG
- Grossman D.
Support for and interest in alternative models of medication abortion provision among a national probability sample of U.S. women.
]. While we expected people seeking abortion to be interested in more accessible ways to obtain care, the high level of support observed may be indicative of a shift in preferences towards care outside of a facility, due to more experience with barriers accessing care, greater comfort with abortion, and/or an artifact of being surveyed in a clinic setting where clinic-level endorsement of an over-the-counter product may have been inferred.
Consistent with previous research [
[5]- Biggs MA
- Ralph L
- Raifman S
- Foster DG
- Grossman D.
Support for and interest in alternative models of medication abortion provision among a national probability sample of U.S. women.
], people who faced financial barriers that led to delay were most interested in an over-the-counter option. While there are many unknowns about the out-of-pocket costs of a future over-the-counter abortion product, most people assumed it would be less expensive. In the U.S., providers have reported that the cost of the medications is under $100, yet the average cost to obtain an in-clinic medication abortion is over $500 [
[12]- Witwer E
- Jones RK
- Fuentes L
- Castle SK.
Abortion service delivery in clinics by state policy climate in 2017.
,
[13]Kaiser Family Foundation
The Availability and Use of Medication Abortion.
. This expense can be catastrophic for those living below their state's median household income [
[14]- Zuniga C
- Thompson TA
- Blanchard K.
Abortion as a catastrophic health expenditure in the United States.
]. While, the out-of-pocket costs of an over-the-counter medication abortion product would depend on insurance coverage and whether abortion funds offset the cost, the costs to the patient are likely to be lower than facility-based care [
[15]- Chinery L
- Allaouidine C
- Tomazzini A
- Larson M
- Gülmezoglu AM.
Cost of goods sold analysis and recommendations to reduce costs of co-packaged mifepristone-misoprostol for medical abortion.
]. At a minimum, the over-the-counter model could reduce travel-related costs; however, people might still incur the costs of any visits if they access facility-based care to confirm pregnancy completion or to treat any potential complications [
[16]Complications of unsafe and self-managed abortion.
]. Given the high out-of-pocket costs for abortion care, people's desire for an inexpensive alternative should be prioritized [
[14]- Zuniga C
- Thompson TA
- Blanchard K.
Abortion as a catastrophic health expenditure in the United States.
,
[17]- Roberts SCM
- Turok DK
- Belusa E
- Combellick S
- Upadhyay UD.
Utah's 72-hour waiting period for abortion: experiences among a clinic-based sample of women.
,
[18]- Jones RK
- Upadhyay UD
- Weitz TA.
At what cost? Payment for abortion care by U.S. women.
. Furthermore, people receiving care under an over-the-counter model of care may benefit from complete and accurate information of what to expect and how to manage the abortion process [
[16]Complications of unsafe and self-managed abortion.
].
The majority of respondents selected several advantages of the over-the-counter model, with most appreciating not going to a clinic, as well privacy and convenience. Privacy preferences may stem from a desire to avoid negative reactions from others, including clinic protestors [
19- Shellenberg KM
- Moore AM
- Bankole A
- Juarez F
- Omideyi AK
- Palomino N
- et al.
Social stigma and disclosure about induced abortion: results from an exploratory study.
,
20- Astbury-Ward E
- Parry O
- Stigma Carnwell R.
Abortion, and disclosure—findings from a qualitative study.
,
21- Biggs MA
- Brown K
- Foster DG.
Perceived abortion stigma and psychological well-being over five years after receiving or being denied an abortion.
,
22- Kimport K
- Cockrill K
- Weitz TA.
Analyzing the impacts of abortion clinic structures and processes: a qualitative analysis of women's negative experience of abortion clinics.
], and to avoid a clinic environment which may exacerbate abortion stigma [
[22]- Kimport K
- Cockrill K
- Weitz TA.
Analyzing the impacts of abortion clinic structures and processes: a qualitative analysis of women's negative experience of abortion clinics.
].
People also highlighted a number of disadvantages of the over-the-counter model, mostly related to concerns about people's ability to take the pills correctly, lack of contact with a clinician, and effectiveness, although fewer reported concerns that the over-the-counter model would be less safe (14%) when compared to previous research in the general population (43%) [
[5]- Biggs MA
- Ralph L
- Raifman S
- Foster DG
- Grossman D.
Support for and interest in alternative models of medication abortion provision among a national probability sample of U.S. women.
]. People's view that not seeing a clinician would be a disadvantage to an over-the-counter model may be rooted in a preference for facility-based care, the desire or need for a clinical experience that provides support, affirmation [
[23]- Altshuler AL
- Ojanen-Goldsmith A
- Blumenthal PD
- Freedman LR.
A good abortion experience: a qualitative exploration of women's needs and preferences in clinical care.
], an environment that destigmatizes abortion and improves the overall abortion experience [
[24]Obstacle course: the everyday struggle to get an abortion in America.
], and/ or greater comfort and familiarity with the medicalized model of abortion care where clinicians serve as the gatekeepers of access [
[25]Recognizing medicalization and demedicalization: discourses, practices, and identities.
]. A scenario where medication abortion is available over the counter will need to consider these perspectives and identify and develop the resources needed, if any, to support the abortion process (e.g., accompaniment, hotlines, written information, apps, etc.). However, to support an over-the-counter switch, there is also a need to conduct the necessary research demonstrating that people can take medication abortion safely without clinical supervision.
Across demographic characteristics, support for an over-the-counter model was high, although we also observed significant subgroup differences according to language group, race/ethnicity and educational level. Differences by those who spoke English vs another language at home (92% vs 62%) may be due to varied exposures to models of care in people's countries of origin [
[26]- Lara D
- García SG
- Wilson KS
- Paz F.
How often and under which circumstances do Mexican pharmacy vendors recommend misoprostol to induce an abortion?.
,
[27]- Diamond-Smith N
- Percher J
- Saxena M
- Dwivedi P
- Srivastava A.
Knowledge, provision of information and barriers to high quality medication abortion provision by pharmacists in Uttar Pradesh.
. The finding that college-educated and White respondents were most supportive and interested in over-the-counter access to medication abortion was unexpected, and possibly due their greater general support for abortion. A national study of people seeking abortion found that White and college-educated people were less likely to believe abortion is morally wrong and more likely to be in favor of the legal right to abortion than people who identified as Black, Hispanic/Latina or had less than a college education [
[28]- Woodruff K
- Biggs MA
- Gould H
- Foster DG.
Attitudes toward abortion after receiving vs. being denied an abortion in the USA.
]. Other research has found that those identifying as White have significantly higher levels of perceived and internalized abortion stigma [
[21]- Biggs MA
- Brown K
- Foster DG.
Perceived abortion stigma and psychological well-being over five years after receiving or being denied an abortion.
,
[29]Correlates of perceived and internalized stigma among abortion patients in the USA: an exploration by race and Hispanic ethnicity.
, which may partially explain their higher levels of interest in over-the-counter access to abortion. Another interpretation of this finding is that people of color may have more concerns about the out-of-pocket costs of an over-the-counter product, and/or greater mistrust in the quality or accessibility of over-the-counter medications. For example, one study examining the availability of progestin-only emergency contraception (EC) over-the-counter found that pharmacies located in low-income neighborhoods were more likely to deny young people access to EC than those located in high-income neighborhoods [
[30]- Wilkinson TA
- Clark P
- Rafie S
- Carroll AE
- Miller E.
Access to emergency contraception after removal of age restrictions.
]. Further research should examine the reasons for differing levels of interest in an over-the-counter model by subgroups. These varied levels of interest underscore the importance of offering a range of options to access abortion—whether over the counter, facility-based or other model of care– that match people's preferences, as well as the need to examine the potential impact of these models on disparities in access to abortion.
This study should be examined in the context of its limitations and strengths. First, our sample is limited to people accessing facility-based abortion care and only represents the perspectives of people who chose or had the resources to access in-person care. People with barriers accessing care and who consider abortion but do not reach a facility may be even more interested in an over-the-counter model. Furthermore, by being surveyed at a clinic, people may have assumed clinic-level endorsement of an over-the-counter model, thus biasing responses towards greater support. Another study limitation is that while the scenario describing our primary outcome has been previously used [
[5]- Biggs MA
- Ralph L
- Raifman S
- Foster DG
- Grossman D.
Support for and interest in alternative models of medication abortion provision among a national probability sample of U.S. women.
], the scenario itself was not cognitively tested and its reading level may have been too high for some of our study participants to understand, potentially limiting the validity of our findings. Moreover, we presented a hypothetical ideal over-the-counter scenario, covering a breadth of services—24-hour hotline, follow-up clinic-based care– that may not be available to people accessing a future over-the-counter medication abortion product. Furthermore, this study was fielded just before the COVID-19 pandemic, which forced people to minimize in-person clinical visits, potentially increasing interest in and demand for an over-the-counter option [
[6]- Aiken ARA
- Starling JE
- Gomperts R
- Tec M
- Scott JG
- Aiken CE.
Demand for self-managed online telemedicine abortion in the United States during the coronavirus disease 2019 (COVID-19) pandemic.
]. In this context, an over-the-counter option offers an approach to early abortion care that could decrease transmission of COVID-19 [
[31]The no-test abortion is a patient-centered abortion.
,
[32]- Ramaswamy A
- Weigel G
- Sobel L
- Salganicoff A.
Medication abortion and telemedicine: innovations and barriers during the COVID-19 Emergency.
. Also, we did not ask people whether they received counseling prior to completing the survey, whether they preferred a certain type of abortion–medication abortion or an in-clinic procedure–nor did we document the type of abortion people ultimately had, whether they had ever had a medication abortion, or if they lived in an urban or rural area. This information would have given us a better understanding of how people's interest in an over-the-counter model might differ by their abortion experiences, preferences for abortion type, or if counseling influenced their responses. Additionally, people selected advantages and disadvantages from a pre-specified list including an open-ended “other” category, which likely biased people to select from the list. Open-ended questions would have generated a broader range of responses. A study strength is our large sample size, which represented people accessing care across the U.S., and demographically similar to a national sample of people presenting for abortion care in terms of age, race/ethnicity and marital status [
[33]Population group abortion rates and lifetime incidence of abortion: United States, 2008–2014.
].
Together, these findings highlight abortion patients’ interest in an over-the-counter model of abortion care that they perceive has the advantage of being safe, convenient, affordable, and private. While it is unclear whether in practice an over-the-counter model of abortion care would be more affordable than facility-based care, our findings suggest that patients are interested in having more convenient and affordable choices. Together, our results have the potential to inform a public discourse and shift public perceptions surrounding medication abortion by highlighting the need for affordable options and normalized abortion access. The COVID-19 pandemic has spurred tremendous innovation in medication abortion care, including the implementation of a no-test protocol and the Food and Drug Administration removing the in-person dispensing requirement for mifepristone [
[34]- Raymond EG
- Grossman D
- Mark A
- Upadhyay UD
- Dean G
- Creinin MD
- et al.
Commentary: No-test medication abortion: a sample protocol for increasing access during a pandemic and beyond.
]. Furthermore, demand for an online telemedicine service increased during the pandemic, particularly in areas that faced restrictions on in-clinic abortion access [
[6]- Aiken ARA
- Starling JE
- Gomperts R
- Tec M
- Scott JG
- Aiken CE.
Demand for self-managed online telemedicine abortion in the United States during the coronavirus disease 2019 (COVID-19) pandemic.
], and recent research suggests that most people understand key instructions found in a drug facts label prototype for medication abortion [
[37]Biggs M. Antonia, Ehrenreich Katherine, Bustamante Claudie Kiti, et al. Comprehension of an Over-the-Counter Drug Facts Label Prototype for a Mifepristone and Misoprostol Medication Abortion Product. Obstetrics & Gynecology in press.
]. These innovations have brought medication abortion a step closer to over-the-counter status. Efforts to move medication abortion over-the-counter can be informed by strategies to move emergency contraception and oral contraceptives over-the-counter [
[35]- Raymond EG
- Chen P-L
- Dalebout SM.
Actual use” study of emergency contraceptive pills provided in a simulated over-the-counter manner.
,
[36]High unintended pregnancy rate spurs efforts to ease contraceptive access.
. Given the documented interest in and potential benefits of over-the-counter access to medication abortion, it is essential to carry out the necessary research assessing the safety of an over-the-counter model.
Author contributions
DG conceived and designed the study and obtained funding. RB, KE, and NM participated in site recruitment, review of data collection instruments, programming study instruments, obtaining IRB approval, and overseeing data collection. NM conducted data cleaning, coding, and preliminary analyses. MAB conducted final data analyses and drafted the manuscript. All authors, including LR, JP, NK, KB, KW, participated in the study design, study planning, and review and approval of the final manuscript.
Article info
Publication history
Published online: January 23, 2022
Accepted:
January 12,
2022
Received in revised form:
January 8,
2022
Received:
December 23,
2020
Copyright
© 2022 The Authors. Published by Elsevier Inc.