51˶

Telemedicine Abortion Gains Momentum During Pandemic

— But FDA regulations on mifepristone still limit access

Last Updated June 5, 2020
MedpageToday
An advertisement showing a woman holding a smart phone and using the carafem app to schedule an abortion.

As access to in-person abortion clinics dwindled during the COVID-19 pandemic, providers have seen increased demand and awareness of another method of abortion care: telemedicine.

Melissa Grant, chief operating officer of , a national abortion and birth control clinic, said that "there's definitely been a marked increase" in telemedicine abortions since stay-at-home orders were put in place.

Carafem, which directly mails abortion pills to patients as a part of a nationwide study, previously had one to two patients a week that were interested in receiving medication abortions from home. But since the pandemic, that number has increased to around eight to 10 patients a week, Grant said.

"What we've noticed since the pandemic started, is that it ultimately became even more challenging for people to travel," Grant told 51˶. Some patients faced new childcare barriers or economic strain, and "all of those things together increased the number of people looking at this option."

"Necessity oftentimes breeds innovation," Grant added. "Abortion doesn't stop being a necessity because of things going on in the world around it."

Some data have suggested that abortion via telemedicine is safe and effective, with complication rates comparable to in-person medical abortion procedures. Although the pandemic has increased public awareness around telemedicine for abortion care, FDA regulations on mifepristone continue to limit most patients from accessing abortions remotely.

Combined, mifepristone and misoprostol are necessary medications to terminate a pregnancy; but mifepristone is regulated under the FDA's risk evaluation and mitigation strategies (REMS) protocol. Under REMS, mifepristone must be dispensed from provider to patient directly, in a clinic, hospital, or other medical setting. Although the actual abortion occurs at a patient's home, they cannot pick up the drug from the pharmacy, or receive it in the mail.

The requirement to pick up abortion medications in person can create barriers to access, advocates say. Grant said that around 30% of carafem's patients travel more than 100 miles to see an abortion provider.

David Hackney, MD, division director of maternal fetal medicine at University Health Hospitals in Cleveland, said that interest in telemedicine has grown in multiple medical specialties, including reproductive healthcare.

"A whole world of things that we used to never dream of doing remotely or via telemedicine, we are now being encouraged to do via telemedicine," Hackney, who also serves as the American College of Obstetricians and Gynecologists (ACOG) Ohio section legislative chair, said in an interview.

But although awareness around telemedicine abortion has grown during the pandemic, FDA restrictions on dispensing mifepristone have not changed.

"Although it's an issue we've been advocating for in the past, it's become much more urgent now," Hackney said. He added that his opinions are not on behalf of his employer.

Last week, ACOG filed a against the FDA, asking the agency to lift REMS restrictions for mifepristone during the pandemic. In a statement, ACOG president Eva Chalas, MD, said that while the healthcare community at large has found new ways for patients to access care through telemedicine, "the FDA's decision to maintain medically unnecessary restrictions on mifepristone is a glaring exception."

Many ob/gyns agree that there is no medical necessity for the FDA to place dispensing restrictions on mifepristone.

"Patients are getting the medication and taking it at home," said Daniel Grossman, MD, a professor of obstetrics and gynecology at University of California San Francisco, who has researched telemedicine abortion. "There's really no reason why they have to receive it in the clinic."

While national restrictions still prohibit a majority of patients from accessing abortion medications outside of healthcare facilities, there is one avenue of care for those seeking an abortion from home. The , an FDA-approved project that provides medication abortions via telehealth, sends mifepristone and misoprostol directly to patients' doors. Patients that live within a participating state, are less than 10 weeks pregnant, and are considered low-risk can receive abortion care without leaving their home.

The study oversees clinics (including carafem) that provide the procedure in 13 states and the District of Columbia. Participants receive a virtual consultation to assess eligibility, and after they undergo necessary testing such as an ultrasound, pelvic exam, or at-home pregnancy test, providers mail abortion medications to their home.

According to Tara Shochet, PhD, MPH, senior program associate on the study, TelAbortion's enrollment has recently doubled. Twice as many women had abortions through the program in March and April than they did in January and February. Since the start of the program in 2016, TelAbortion has shipped nearly 1,000 packages.

In an of nearly 250 TelAbortion packages, direct-to-patient telemedicine abortion was successful in 93% of the 190 patients who had abortion outcome data available.

Of 217 patients who provided follow-up data, two had serious adverse events: one had a seizure after an aspiration performed for bleeding, and the other had severe anemia. Sixteen additional patients (7%) presented to the emergency department, most for bleeding or pain, but one for dizziness and one to get Rh immune globulin. Of those 16 patients, two had aspirations, one had products of conception removed from her cervical os, three received medication for pain or nausea, and one was treated for a urinary tract infection. Nine received no medical treatment.

"You see that very few were hospitalized, and the majority that went to the emergency department were for bleeding or pain," said Ashanda Saint Jean, former director of obstetrics and gynecology for the NewYork-Presbyterian/Allen Hospital Ambulatory Care Network in New York City.

"Only two of the 16 patients needed aspirations," Saint Jean, who was not involved in the study, said in an interview. "That tells you how efficacious this method of termination is."

Shochet said that the study recently expanded its sample size to 2,500 participants, for the purposes of both improved subgroup analyses and the benefit of keeping the service available. "Telabortion is safe, it is effective, and it is increasing access to folks who would not have it otherwise," Shochet said in an interview.

Gabriela Aguilar, MD, MPH, a family planning specialist from the Yale School of Medicine in New Haven, Connecticut, told 51˶ that increased conversations around telemedicine abortion during the pandemic has the potential to bring long-standing change.

Although Aguilar does not provide direct-to-patient abortions via telemedicine in Connecticut, she said clinicians are thinking about what tests are medically necessary to dispense abortion pills, as providers try to limit patient exposures to COVID-19.

"I think that the pandemic is giving us the chance to look at what is actually, medically necessary to do a medication abortion," Aguilar said. "Do you need that ultrasound? Do you need that lab work if you're very early in pregnancy? Do you need to have an in-clinic visit for somebody who is otherwise healthy and very low-risk?"

She added that patients with risk factors for an ectopic pregnancy, including prior tubal ligation, prior ectopic pregnancy, abnormal uterine bleeding, or presence of an IUD during pregnancy, would need a physical exam. But for low-risk patients, Aguilar said that COVID-19 could be an opportunity to re-examine the provision of medical abortion.

"It is safe to provide telemedicine abortion, and the pandemic has given us a unique opportunity to prove that."

  • Amanda D'Ambrosio is a reporter on 51˶’s enterprise & investigative team. She covers obstetrics-gynecology and other clinical news, and writes features about the U.S. healthcare system.