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Fok 2018

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Elita Rahma
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REVIEW

CURRENT
OPINION Abortion through telemedicine
Wing Kay Fok a and Alice Mark b

Purpose of review
Medical abortion offers a well tolerated and effective method to terminate early pregnancy, but remains
underutilized in the United States. Over the last decade, ‘telemedicine’ has been studied as an option for
medical abortion to improve access when patients and providers are not together. A number of studies
have explored various practice models and their feasibility as an alternative to in-person service provision.
Recent findings
A direct-to-clinic model of telemedicine medical abortion has similar efficacy with no increased risk of
significant adverse events when compared with in-person abortion. A direct-to-consumer model is currently
being studied in the United States. International models of direct-to-consumer medical abortion have shown
promising results.
Summary
The introduction of telemedicine into abortion care has been met with early success. Currently, there are
limitations to the reach of telemedicine because of specific restrictions on mifepristone in the United States
as well as laws that specifically prohibit telemedicine for abortion. If these barriers are removed,
telemedicine can potentially increase abortion access.
Keywords
medical abortion, mifepristone, misoprostol abortion, Risk Evaluation and Mitigation Strategy, telabortion,
telemedicine

INTRODUCTION and reproductive health [6–8]. Inherent to telemed-


Telemedicine was first coined in the 1970s to mean icine is the spatial or geographic separation of
‘healing at a distance’ [1]. Over time, the field patient and doctor. For that reason, the provision
has evolved significantly because of technological of medical abortion lends particularly well to tele-
advancements, and likewise, the definition and medicine, and over the last decade, there has been a
applications have also undergone multiple trans- movement to explore various telemedicine models
formations. Telemedicine involves the use of com- for this purpose.
munication networks for delivery of healthcare In the United States, obtaining a medical abor-
services and medical education from one geograph- tion is a multistep process. Traditionally, a patient
ical location to another, primarily to address chal- seeks care at a clinic where pretreatment screening
lenges like uneven distribution and shortage of including labwork, ultrasound and assessment of
infrastructural and human resources [2]. There is eligibility occur. She then undergoes counseling,
no single or uniform telemedicine application. followed by consent [including signing of an Food
Rather it is heterogenous in nature and can range and Drug Administration (FDA)-approved patient
from videoconferencing platforms, to wearables, to agreement]. Afterwards, she is given the abortion
mobile applications. For example, telemedicine is medications (mifepristone and misoprostol). In
used in psychiatry to help link patients in the emer- some facilities, the first medication, mifepristone,
gency department with outpatient mental health is given at the facility and the patient leaves with the
services, in dermatology to provide greater accessi-
bility to dermatologic services for rural populations, a
Stanford University, Stanford, California and bNational Abortion Feder-
and in cardiology to enable remote monitoring ation, Washington, DC, USA
through implantable devices [3–5]. Correspondence to Wing Kay Fok, MD, MS, Stanford University, 300
In reproductive healthcare, telemedicine has Pasteur Drive HG332, Stanford, CA 94305, USA. Tel: +1 650 724 4683;
been used to assist with glycemic control in preg- e-mail: [email protected]
nant women with diabetes, teach reproductive Curr Opin Obstet Gynecol 2018, 30:394–399
health in rural areas and improve adolescent sexual DOI:10.1097/GCO.0000000000000498

www.co-obgyn.com Volume 30  Number 6  December 2018

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Abortion through telemedicine Fok and Mark

restrictions on medical abortion provision, and laws


KEY POINTS that specifically prohibit the use of telemedicine in
 Provision of medical abortion through telemedicine is abortion care.
effective and acceptable to women and is not The REMS is a set of additional restrictions that
associated with a higher prevalence of adverse events the FDA may impose on a drug, and is intended for
compared with in-person provision of the service. drugs that are known or suspected to cause serious
adverse effects beyond what the label instructions
 The Food and Drug Administration Risk Evaluation and
Mitigation Strategy for mifepristone limits the reach of can convey. There are three elements to the mifep-
medical abortion through telemedicine. ristone REMS (Table 1). Because of the REMS, only
providers who have completed certification can
 Some states have specific legislation that ban medical dispense mifepristone to a patient, effectively bar-
abortion delivered by telemedicine.
ring pharmacies in the United States from carrying
 Global models of telemedicine show that direct-to- and dispensing the medication directly to patients.
consumer models are effective with high Although the 2016 FDA label update to mifepristone
satisfaction rates. eliminated a number of other unnecessary restric-
tions, the original REMS remains and continues to
hinder convenient, on-demand access to medical
abortion in the United States. It also discourages
misoprostol to take at home. In some facilities, both
low-volume abortion providers, such as family
medications are given to the patient to take at home.
medicine physicians, from performing medical
The actual abortion, that is, the expulsion of the
abortions because of the challenge of stocking
pregnancy, occurs once she takes the misoprostol at
mifepristone. When considering abortion through
home. One to two weeks later, the patient has a final
telemedicine, the existence of REMS directly
assessment of abortion completion. When mifepris-
impacts what models are feasible.
tone was first approved in 2000, each step (with the
The number of abortion restrictions has risen
exception of the abortion itself) occurred in the
sharply over the last decade, with one-third of the
same clinic. Since 2000, the regulations around
nearly 1200 restrictions enacted since Roe v Wade
the medical abortion process have eased in an effort
being introduced in the last 8 years [9]. Medical
to be more patient-centered. For example, mifepris-
abortion is limited by state laws that only allow
tone and misoprostol can be taken at home (previ-
licensed physicians to provide medical abortion
ously had to be ingested in the clinic) and follow-up
and prohibit midlevel providers from doing so.
can occur remotely by a variety of means. Telemedi-
In these states, where physician-to-patient ratio is
cine is a further step towards making medical abor-
low, telemedicine may have the greatest impact to
tion easier and more accessible, by presenting an
increasing access. Similarly, telemedicine for abor-
alternative service option where some or all of the
tion has been targeted by restrictive legislation. At
abortion service takes place outside of the facility.
the time of publication, 19 states require that the
clinician providing a medical abortion be physically
CHALLENGES TO ACCESS IN THE UNITED present during the procedure, thereby prohibiting
STATES the use of telemedicine to prescribe medication for
Medical abortion access in the United States is chal- abortion remotely [10].
lenged by multiple regulatory, legal, and logistical A patient’s distance from the clinic or provider is
barriers. These include the US FDA Risk Evaluation a barrier to access. In 2014, American women had to
and Mitigation Strategy (REMS) that limits how travel a median distance of 10.8 miles to reach an
and where mifepristone can be distributed, legal abortion clinic, with 20% of women having to travel

Table 1. United States Food and Drug Administration Risk Evaluation and Mitigation Strategy

Mifeprex Risk Evaluation and Mitigation Strategy (REMS) Elements

Healthcare providers who prescribe Mifeprex must be specially certified


Mifeprex must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices, and hospitals, by or under the
supervision of a certified prescriber
Mifeprex must be dispensed to patients with evidence or other documentation of safe use conditions

Adapted from FDA-Approved Mifeprex Risk Evaluation and Mitigation Strategies (https://www.accessdata.fda.gov/scripts/cder/rems/
index.cfm?event=IndvRemsDetails.page&REMS=35).

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Family planning

FIGURE 1. Median distance to the nearest abortion provider by county, 2014. Data from [11].

42.5 miles or more, illustrating substantial spatial DIRECT-TO-CLINIC MODEL


disparities in access to abortion [11]. When distance In the direct-to-clinic model, a patient seeks care in a
to the nearest clinic was examined by county, coun- local clinic and communicates with a provider (usu-
ties where women would have had to travel 180 ally a physician) who is off site via teleconference,
miles or more were concentrated in the middle of obviating the need for a physician on site. This
the country and were generally rural (Fig. 1). Exter- model best serves more rural regions of the country
nal factors such as inclement weather, need to use where the provider-to-patient ratio is low. In the
multiple means of transportation, limited access to United States, this model was first formally intro-
safe and reliable transportation, child care, and sick duced in Iowa at Planned Parenthood of the Heart-
leave polices also impose burdens and increase the land in 2008.
time it takes women to travel even short distances In a prospective cohort study conducted at
[12]. Unlike uterine aspiration, medical abortion Planned Parenthood of the Heartland, women were
challenges that pertain to distance can be amelio- given the option of medical abortion through tele-
rated by the adoption of telemedicine. medicine or face-to-face visit [13]. In the telemedi-
cine group, women could go to a satellite location
where no physician was located and had ultrasound,
TELEMEDICINE MODELS lab testing, and screening. Once she was determined
The distinguishing factor of all telemedicine abor- to be eligible, the patient had a videoconference call
tion models is that the prescribing provider and the with a physician. After counseling and completing
patient are not in the same location. In the United required consents, the physician would remotely
States, this has resulted in two main models, the unlock a drawer in front of the patient that
direct-to-clinic model and the direct-to-consumer dispensed mifepristone and misoprostol. In the
model. face-to-face group, women traveled to the central

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Abortion through telemedicine Fok and Mark

location to have all services there and counseling days, the clinic can make appointments and screen
and consent with the physician in person. When patients and the physician can remotely conference
compared with face-to-face provision, in the tele- in for counseling and consent. After videoconfer-
medicine group, complete abortion without the encing, mifepristone can be dispensed on site. Espe-
need for surgical intervention, adverse events, and cially in remote or rural areas where providers are
satisfaction were not statistically different. Telemed- not frequently available or are traveling from far
icine patients had greater odds of recommending away, direct-to-clinic models have a role in expand-
the service compared with face-to-face patients ing access. However, in direct-to-clinic models,
[odds ratio (OR) 1.72]. A significantly higher pro- patients still need to come to a clinic to receive
portion of face-to-face patients (32%) complained medical abortion. Although these models manage
about the waiting time in the clinic compared with provider shortages and increase flexibility in patient
telemedicine patients (7%). When predictors of sat- scheduling, they do not necessarily improve the
isfaction were examined, younger age, less educa- burden of transportation, time, and cost to patients.
tion and nulliparity were associated with preference Patients are still responsible for coming to a clinic to
for in-person visits. Loss to follow-up in both groups receive their care.
were similar, and comparable with previously
reported data.
In a follow-up qualitative study to understand DIRECT-TO-CONSUMER MODEL
the telemedicine experience, in-depth interviews In a direct-to-consumer model, women interact
were conducted with women and clinic staff [14]. directly with providers through a video call and
Women reported decreased travel and greater avail- the abortifacient medications are sent to women
ability of locations and appointment times as by mail or prescription, rather than being obtained
advantages of telemedicine. Some women who in a clinic. In this model, there are no requirements
chose telemedicine preferred interacting with the as to where either party is located, or where screen-
provider through a webcam whereas others were ing is performed, adding flexibility. This model also
indifferent. Clinic staff, overall, felt there was mini- has the benefit of decreasing overhead costs to
mal disruption to work flow by adopting a telemed- clinics and alleviating workflow burden. This model
icine model. These sentiments were similarly is part of an ongoing study introduced in Hawaii,
expressed by providers and staff at a Planned Par- Oregon, New York, Washington and Maine and
enthood clinic in Alaska where telemedicine was results are pending. As medications through the
used for medical abortion starting in 2011. Staff felt mail are not consistent with the REMS agreement,
that telemedicine visits involved the same overall the study is being done through an Investigational
processes and clinic flow and physicians reported no New Drug (IND) program that is sponsored by the
differences in their interaction with the patient [15]. research organization.
In a retrospective cohort study, comparing Direct-to-consumer models are especially prom-
adverse events associated with obtaining medical ising in areas where abortion access is limited. If
abortions through telemedicine or in-person visit, patients could have screening and laboratory testing
0.18% of telemedicine patients had any clinically by their primary providers and access an abortion
significant adverse event and 0.32% of in-person provider remotely who then mails them medica-
patients had any clinically significant adverse event tions, they would not need to travel to a clinic to
&&
[16 ]. These rates are similar to previously reported access medical abortion. However, for this model to
incidence of 0.2% for serious adverse events [17,18]. be viable, the REMS agreement would need to
Therefore, telemedicine provision of medical abor- be dismantled.
tion was not associated with a significantly higher
prevalence of adverse events compared with in-per-
son provision of the service. Adverse events ABORTION THROUGH TELEMEDICINE
included hospital admission, surgery (not including GLOBALLY
vacuum aspiration of the uterus), blood transfusion Telemedicine abortion has been used extensively
and death. outside the United States in settings where medical
Direct-to-clinic models are viable in situations abortion is legally restricted, or abortion services are
where, like Planned Parenthood of the Heartland, geographically limited, or both. In countries where
there are satellite facilities with no provider con- safe abortion is restricted, global hotlines like
nected to a central facility where a provider is Women on Web (www.womenonweb.org) or local
located. In addition, it is a model that works where hotlines give access to medical abortion. In Women
a clinic has medical abortion available but does not on Web, a woman seeking abortion has an online
have a physician on site every day. On nonphysician consultation with a clinician. If the woman is

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Family planning

eligible and below 10 weeks, mifepristone and miso- (1%) and 90% of women were pleased with not
prostol are mailed to her home. Analyses of the undergoing an ultrasound or pelvic exam
&
service show high rates of success and satisfaction [28 ,29,30]. However, more women in the United
[19,20]. Women who use the service are more likely States had neutral feelings (were less positive) about
than women in a clinical setting to end up with a the protocol. In addition, doing follow-up outside
surgical intervention, and this rate varies by global the clinic will simplify medical abortion and work
region [21]. Although the rate of surgical interven- well for patients who choose medical abortion
tions rises with gestational age, as it does in the remotely. Serum or urine hCG follow-up, multilevel
clinical setting, regional differences point to local or low-sensitivity pregnancy testing, or symptom-
clinical practice around the treatment of incomplete atic screening for abortion completion are all viable
abortion that affect intervention rates. Local abor- options [31]. The National Abortion Federation and
tion hotlines provide a range of services, including the World Health Organization do not require in-
instructions about how to end a pregnancy with person medical abortion follow-up as the success
misoprostol [22,23], expanding medical abortion rates are so high [32,33].
access into the second trimester [24,25], and work- For telemedicine to be viable, clinical and
ing in conjunction with local accompaniment mod- administrative policies need to be established [34].
els of care [25]. In general, few states have established legislation
Where abortion is legal but services are remote, regarding standards for billing and reimbursement
telemedicine has been used to successfully expand for telemedicine services of any type. As abortion
abortion access. In 2015 in Australia, the Tabbott services are often linked with additional restrictions
foundation launched a direct-to-consumer telemed- with regards to insurance coverage, reimbursement
icine service. In this service, women are screened by schemes specific to abortion through telemedicine
phone and, if likely to be eligible, obtain preproce- remain underdeveloped at this time.
dure testing (ultrasound, hemoglobin, blood type
and quantitative serum human chorionic gonado-
tropin concentration) through a local clinician. CONCLUSION
Once the testing is complete, the patient has a Telemedicine has potential to expand access to early
phone consultation with a Foundation doctor and medical abortion, especially for people living in
medications are sent to her home or an eligible areas where abortion is legally or geographically
address. In a retrospective analysis of 1010 patients restricted. Telemedicine in the United States is
who received medications, 965 women took the full unique because of the restrictions placed by the
course of medications. Of the 78% of women who FDA and the REMS and until the REMs are removed,
had follow-up, 96% had a complete abortion and the full impact of telemedicine will not be realized.
&&
95% had no further clinical encounters [26 ]. Sixty A direct-to-consumer model is currently under
percent of women who used the service were from investigation. Telemedicine may help expand
rural or remote areas compared with 29% of the access and increase the proportion of abortions that
Australian population, indicating that the service are undertaken by medical route in the United
was disproportionately used by women who had States.
poor access to in-person abortion services. However,
40% still came from major cities showing that some Acknowledgements
women may prefer telemedicine services even when None.
abortion is readily available.
Financial support and sponsorship
FUTURE DIRECTIONS None.
There are other ongoing efforts to simplify the med- Conflicts of interest
ical abortion process, such as elimination of the
There are no conflicts of interest.
pretreatment ultrasound, or using remote follow-
up, that can be combined with telemedicine. It has
been previously demonstrated that last menstrual REFERENCES AND RECOMMENDED
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