A recently published study sought to evaluate the safety and effectiveness of telehealth medical abortions provided in two different ways: synchronously (via video interaction between patient and provider) and asynchronously (via secure text messaging, with no scheduled interaction between patient and provider).
Based on the patients’ post-abortion follow-up responses, the researchers assert: “Telehealth medication abortion is effective, safe and comparable to published rates of in-person medication abortion care.”
The researchers stated they designated the telehealth models safe if there were no serious adverse reactions and effective if the abortions were complete without additional intervention.
Asynchronous telehealth is often used for patient intake or follow-up care, including follow-up for telehealth medical abortions. Usually, though, the actual telehealth medical abortion appointment is done via real-time video conferencing.
However, live interaction is not required for all forms of telehealth; some clinics use only asynchronous communication with no “real-time” contact with the abortion provider. In asynchronous telehealth care, the patient shares information through a patient portal; the provider reviews the information and responds later. No appointment is needed for these “no-touch” abortions.
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In the U.S., medical abortion provided via telehealth was not possible until recent years.
The Food and Drug Administration (FDA) puts mifepristone, the first pill in the abortion pill regimen, under a Risk Evaluation and Mitigation Strategy (REMS) because there are serious safety concerns about the risks of the medication.
From 2011 until the first half of 2020, the FDA’s REMS restrictions stated that mifepristone could only be dispensed “in clinics, medical offices and hospitals by or under the supervision of a certified prescriber.”
In 2020, mifepristone remained on the FDA’s REMS list; however, in response to the COVID pandemic, the FDA temporarily suspended the in-person requirement for mifepristone.
This suspension opened the door for telehealth medical abortions, with abortion pills mailed to the patient or dispensed by a certified pharmacy. Though originally temporary, this telehealth allowance continues today under the current Mifepristone REMS Program.
The study, Effectiveness and Safety of Telehealth Medication Abortion in the USA, included telehealth records of 6,034 patients seeking abortions. The patients were “screened using a standardized no-test protocol, primarily relying on their medical history to assess medical eligibility.”
Additionally, self-reported information included the duration of the pregnancy, “based on self-reported date of last menstrual period [LMP] or by ultrasonography, if available.”
According to the FDA, the requirement for determining the age of pregnancy before dispensing mifepristone falls directly to the provider. The FDA guidelines state that all providers of mifepristone must complete a Prescriber Agreement Form. This Agreement states that mifepristone must be provided by or under the supervision of a certified prescriber who has the ability to “assess the duration of pregnancy accurately.”
Christa Brown, senior director of Medical Impact with Heartbeat International, notes her concerns about the method of this study: “Although many abortion providers are now using just LMP dating for gestational age, this is very commonly inaccurate.’
The American College of Obstetricians and Gynecologists (ACOG) also acknowledges the likelihood of inaccuracy, noting that 40% of women are off by more than 5 days when estimating the age of their pregnancies based on their LMPs.
Additionally, the authors of the study note:
“Patients who had any risk factors for or symptoms of ectopic pregnancy or were potentially beyond the gestational limit of the virtual clinic were referred for pre-abortion ultrasonography.”
Despite removing the in-person dispensing requirement, the Prescriber Agreements for generic mifepristone and Danco-brand Mifeprex still require the provider to have the “ability to diagnose ectopic pregnancies.”
While the authors note that some study participants were referred for pre-abortion ultrasounds, the safeguards in place were not sufficient to protect all the women in the study.
Six patients in the study sample who received the abortion medications did have ectopic pregnancies, requiring varying degrees of medical intervention; one of whom required a salpingectomy (the removal of one or both fallopian tubes).
The U.S. manufacturer of mifepristone notes that mifepristone is neither effective (it will not terminate an ectopic pregnancy) nor safe (some of the expected side symptoms may be similar to those of a ruptured ectopic pregnancy) for ectopic pregnancies.
ACOG asserts that “patients with an ectopic pregnancy must have timely access to all treatment options.” Additionally noting, “an untreated ectopic pregnancy is life threatening; withholding or delaying treatment can lead to death.”
A doctor “can't diagnose an ectopic pregnancy by examining you;” notes Mayo Clinic; diagnosing an ectopic pregnancy requires “blood tests and an ultrasound.”
While the medical abortion providers sign agreements stating they have the “ability to diagnose ectopic pregnancies,” no-test protocols circumvent the tests needed for the providers to make this diagnosis.
“The idea that we should continue to reduce the medical oversight and care provided to women before, during and after abortion is irresponsible,” Brown said, “and will endanger many more women.”
Tweet This: The idea that we should continue to reduce the medical oversight & care provided to women before, during & after abortion is irresponsible
Of additional note, of the 6,034 patients included in the study, almost 24% (1,421) provided no follow-up contact and were thus excluded from the results since their abortion outcomes could not be known. For those with whom they had no follow-up contact, the majority received asynchronous telehealth services.
Among those who had “unknown outcomes,” the authors note:
“Two requested abortion pill reversal after they took mifepristone but before misoprostol. Both were advised that evidence-based reversal treatment does not exist and referred to urgent in-person care. No further information on their outcomes was available.”
Yet, thousands of women have saved their babies via abortion pill reversal (APR); their living babies are evidence that the reversal treatment does exist. Studies support a 64-68% success rate at reversing an abortion after taking mifepristone. These studies note that the reversal is safe and effective.
In January, Heartbeat International, which manages the Abortion Pill Rescue® Network, announced that more than 5,000 babies have been saved because their mothers chose to reverse their medical abortions.
The authors of the study cite low adverse reaction rates and high effectiveness rates in both synchronous and asynchronous models of telehealth medical abortions. Additionally, they assert, “these results are reassuring as more clinicians begin to provide telehealth abortion care to patients in US states with a ban, under the legal protections of their state’s shield laws.”
According to the Charlotte Lozier Institute, these legal shields are ”protecting abortionists from criminal, civil, and professional consequences when they violate other states’ abortion laws, including laws requiring parental involvement in a minor’s abortion decision.”
Brown has concerns about the findings of Effectiveness and Safety of Telehealth Medication Abortion in the USA, asserting:
“This study leaves us with more questions than answers. How will they know if the pregnant woman is truly the one communicating with them? How will they know if she is a victim of human trafficking? How will they know if she is six weeks or 36 weeks? How will they know if she has an ectopic pregnancy?”
“The FDA warns consumers not to purchase abortion drugs online,” Brown added, “yet the researchers of this study seem to advocate for the same type of abortion - a text without evaluation or assessment of any kind.”
Editor's note: Heartbeat International manages the Abortion Pill Rescue® Network (APRN) and Pregnancy Help News.
