Expanding medication abortion access helps patients access care earlier in pregnancy

Studies performed in the US and other countries demonstrate that medication abortion has a high level of acceptability for most patients seeking pregnancy termination.18 19 In the US, medication abortions accounted for an estimated 60% of all abortions up to 10 weeks’ gestation in 2017, up from 45% of eligible abortions in 2014.20 In a meta-analysis of approximately 4500 patients who had a medication abortion with mifepristone and misoprostol, over 85% were satisfied with the experience.21 Some evidence suggests that improved access to mifepristone enables people to obtain abortion earlier in pregnancy and reduces the need for second-trimester abortion.22 Conversely, studies have shown that abortion restrictions contribute to increases in gestational age at abortion, thereby decreasing eligibility and use of medication abortion.23 24

In the US, policy restrictions have resulted in limited abortion services and clinic closures across the country, increasing the distance people live from the nearest provider.25 Longer travel distances can increase the cost and logistical difficulty of getting to a clinic, delaying access to timely abortion care and imposing burdens on those with the fewest resources.26 27 In particular, Texas’ 6-week ban creates an exceedingly narrow window for people to confirm pregnancy and access abortion care, pushing in-state services out of reach for most Texans.28 During the COVID-19 pandemic, abortion became unattainable for some.24 29 Overlapping barriers of policy restrictions, long travel distances, shelter-in-place orders, and the public health risks of travel have left patients with few options.

Even in settings where there is good access to care in the US, there is inevitably some delay between the initial call to the clinic and having an in-person appointment to obtain medication abortion; in settings with restricted access, that delay may be longer. According to a 2014 US national survey of abortion patients, the average wait time between the scheduling call and obtaining an abortion was approximately 7 days.30 For 7% of patients, their wait time exceeded 14 days.30 For those who do not recognise pregnancy immediately, common even among first-trimester abortion patients,31 32 the delay to care is compounded and may push some patients beyond the gestational duration limit for medication abortion.33 Telehealth provision may reduce the scheduling delay, but it introduces a delay associated with mailing the pills, and requires that patients be able to receive the medications by mail. The advance provision model would effectively shorten the time between the decision to have an abortion and obtaining care to zero days.

How would advance provision of mifepristone and misoprostol work?

Clinicians could screen interested patients for some contraindications to medication abortion prior to pregnancy, while others would need to be evaluated immediately prior to use (table 1). Clinicians could use the screening criteria included in the no-test protocol to exclude patients at higher risk of ectopic pregnancy based on past history.11 Clinicians could also screen in advance for other medical conditions that are contraindications (table 1). These conditions could change over time, and clinicians could give patients a checklist to help them reassess for these contraindications before using the medications and encourage them to call to discuss any change in their health history.

At the time of dispensing, the clinician would provide education on menstrual tracking, pregnancy recognition and testing, how to self-assess for eligibility at the time of pregnancy, how to administer the medications at home, and the necessary follow-up. In particular, the clinician would explain to the patient how to self-assess for ectopic pregnancy risk and gestational duration at the time of pregnancy prior to using the medications (table 1). Patients would be instructed to confirm the pregnancy with a home urine pregnancy test. If they had symptoms suggestive of ectopic pregnancy or if their self-assessed gestational duration was >70 days (or >77 days if that limit is used34), patients would be instructed not to take the medications on their own and instead seek care. Clinicians would also inform patients about the warning signs of complications after taking mifepristone and misoprostol, including haemorrhage and infection, as well as how little or no bleeding could be a sign of ectopic or ongoing pregnancy. This information should be provided both orally and in written format, including directing patients to online resources. Patients could be encouraged to contact the clinician prior to taking the medications to confirm eligibility according to the no-test protocol and to answer questions.

Clinicians would instruct patients to monitor their pregnancy symptoms after taking the pills, expecting them to dissipate within approximately 1 week. Clinicians would also encourage patients to use a home urine pregnancy test 4–5 weeks after administering the medications to rule out ongoing pregnancy, including ongoing ectopic pregnancy. Similar to the no-test protocol,11 patients that have a positive urine pregnancy test would be told to contact a healthcare provider to determine if additional evaluation is needed. Advance provision is envisioned as a complete care model, where the dispensing provider is committed to patient education, screening at the time of use over the telephone or by telehealth, and ensuring patients access the necessary follow-up care in case of complications, ongoing pregnancy or incomplete abortion.

Are people interested in receiving abortion pills in advance?

A US nationally representative survey found that people are interested in alternative methods of obtaining medication abortion, including by advance provision.35 In this national survey of 7022 self-identified women age 18–49 years (English- and Spanish-speaking), nearly half (44%) indicated they supported advance provision of medication abortion, and 22% reported being personally interested in the model.35 Women who had previously had a medication abortion had over twice the odds (adjusted odds ratio (aOR) 2.39, 95% CI 1.51 to 3.79) of supporting advance provision compared with those who had never had an abortion.35 Those who reported experiencing two or more barriers to accessing reproductive healthcare additionally had higher odds (aOR 1.31, 95% CI 1.08 to 1.58) of support compared with those who had never experienced a barrier to accessing care.35

Almost half (48%) of survey respondents indicated advance provision could benefit women by facilitating abortion earlier in pregnancy.35 Respondents’ concerns about advance provision included that people might take the pills incorrectly (55%), that people would not see a clinician before having the abortion (52%) and that the model could be less safe than the standard of care (42%).35 It will be important to address these concerns with future research.

In this survey, people were more supportive of and interested in an advance provision model than they were of over-the-counter (OTC) or online-access models of care.35 One primary difference between advance provision and other alternative provision models is that advance provision ensures some face-to-face interaction with a healthcare provider at the time of dispensing, and a certain level of privacy that some people may prefer over other models, such as OTC access in a pharmacy.

Advance provision may also fit the needs of those interested in a late period pill, where patients “bring back their period” by using a regimen of mifepristone and misoprostol without prior pregnancy confirmation.36 One study found that those with prior abortion experience were more interested in a late period pill than those who had never had an abortion,36 further supporting that those who have had a prior abortion may be potential candidates for advance provision.

Potential challenges and concerns

In many ways, the advance provision model is similar to the no-test medication abortion protocol.11 Patients could be encouraged to contact their provider for a telehealth assessment to confirm eligibility according to the no-test protocol immediately before taking the medications. Despite the self-assessment for gestational age and ectopic risk, it is possible that some patients might use the treatment past 70 or 77 days’ gestation or with an ectopic pregnancy. Evidence shows that mifepristone neither harms nor helps an ectopic pregnancy,37 and the no-test protocol may facilitate quicker entry to care if a patient recognises the relevant warning signs after taking medication abortion, such as having little or no bleeding. Research in the UK suggests that significant adverse events are not more common with the no-test protocol compared with in-person assessment with ultrasound, even though more patients with ectopic pregnancies may be diagnosed after starting treatment with the no-test protocol.8

Diversion of the medications to another person is also a possibility. If the person receiving the medications understands how to screen for appropriate use, the risk of harm is low – and might improve access to early abortion. This is an area that will require further discussion among clinicians, advocates and legal experts in order to better understand the implications of medication diversion for prescribers and patients.

It is unlikely advance provision could be adopted in all US states. Barriers to adopting advance provision across the US include policy restrictions, such as mandatory ultrasound viewing laws, and other restrictions that require an in-person visit at the time of abortion. Even if advance provision is ultimately not widely scaled up, research on its safety and how patients can use the medications with limited clinician oversight could provide contributory evidence that would inform a future move toward OTC availability of mifepristone and misoprostol. As part of its original submission to the FDA requesting approval for OTC availability of levonorgestrel EC in 2003, Women’s Capital Corporation submitted a literature review of eight articles assessing contraceptive behaviour following advance provision of EC in addition to the required label comprehension and actual use studies.38 The FDA noted that “having an advanced provision would simulate the access that consumers would enjoy if the product were available OTC”, and recognised that these studies complemented the actual use study because they included young people and followed participants for a longer period of time.38