In a test program, physicians safely provided women in the United States with medical abortions via a combination of telemedicine and mailed packages, a new study shows. The findings add to a growing body of evidence showing that the telehealth approach is safe, researchers say. In an article published online June 3 in the journal Contraception, Elizabeth Raymond, MD, MPH, of Gynuity Health Projects in New York City, and coauthors say a combination of telemedicine and shipped packages of medications could remove hurdles to access to abortion. Of the 190 women for whom the researchers could report outcomes after the patients were provided abortion medications, 177 underwent complete abortion without requiring a procedure, Raymond and colleagues write. Eleven subsequently underwent abortion with a procedure, and two continued their pregnancy. "This direct-to-patient telemedicine abortion service was safe, effective, efficient, and satisfactory," Raymond and coauthors write. "The model has the potential to increase abortion access by enhancing the reach of providers and by offering people a new option for obtaining care conveniently and privately." Their conclusion echoes the findings of earlier studies of the use of telemedicine for medical abortion. These include a systematic review published in March and a study conducted in the Republic of Ireland and Northern Ireland that was published in 2017. The approach taken in Gynuity's TelAbortion program could help women who live in states that have few clinics that provide abortions. Women in states where the medical procedure is restricted would still need to travel for care, one of the authors of the Contraception article, Beverly Winikoff, MD, MPH, told Medscape Medical News. In addition, physicians must be licensed in the state where their patients are treated. Several states, including Alabama, have recently passed laws intended to make abortion illegal. These measures are seen as a bid to overturn the 1973 Roe v Wade decision, in which the US Supreme Court affirmed women's right to have abortions. In Alabama, physicians who perform abortions could face up to 99 years in prison if a recently passed bill takes effect. "If you are practicing medicine in Alabama, you have to follow Alabama law," Winikoff told Medscape Medical News. She said that Gynuity's TelAbortion approach is "an aid to access. It doesn't circumvent any laws." The TelAbortion program could prove useful to women who would have to travel out of their states for abortions, said Winikoff. There are plans to bring the TelAbortion program to Illinois. That would allow women living in Missouri to drive across the state line and stay in Illinois for a few days to go through the process via telemedicine, said Winikoff, who is president of Gynuity Health Projects and is professor of clinical population and family health at Columbia University's Mailman School of Public Health in New York City. Having the TelAbortion program operate in a neighboring state may help a woman "avoid having to take an airplane to DC or New York or California," she continued. In the new report, the authors describe results of the TelAbortion project offered through organizations in five states. These were Choices Women's Medical Center in New York City, the University of Hawaii, the Oregon Health and Science University, Maine Family Planning, and Planned Parenthood Columbia Willamette in Oregon. Choices Women's Medical Center stopped recruitment in mid-2017 because of slow accrual, but the other sites continue to enroll, Raymond and coauthors write. The researchers conducted this program as a study under an investigational new drug application filed with the US Food and Drug Administration (FDA). They obtained approval for the study protocol from several institutional review boards and registered the project at clinicaltrials.gov. Of the 248 TelAbortion study participants who received the medication packages, meaningful follow-up data were available for 217 patients. Of this group, two women (1%) reported serious adverse events. Both were hospitalized, one for a seizure after an aspiration performed for bleeding, and the other for severe anemia (hemoglobin level of 6.3 g/dL) 7 days after ingestion of mifepristone (multiple brands) at 56 days' gestation. "We judged that neither event would have been averted had the abortion medications been provided in person," the authors write. In addition, 16 other participants presented to emergency departments or urgent care centers: 14 for bleeding and/or pain, one for dizziness, and one to receive Rh immune globulin. Of these 16 participants, two underwent aspirations, one had products of conception manually removed from her cervical os, three received medication for pain and nausea, and one was treated for a urinary tract infection. The other nine received no medical treatment. A further 11 participants had clinic or office visits. Of this group, eight underwent outpatient aspirations, and three had no reported medical treatment. The investigators say that 159 participants who completed the satisfaction questionnaire were "highly satisfied" with the TelAbortion service. Respondents said they valued the program for its convenience (77%) and privacy (45%), the authors write. In the TelAbortion study, participants took part in a videoconference with a clinician and underwent laboratory tests and ultrasound procedures at facilities of the patients' choice. Eligible patients received a package containing mifepristone, misoprostol (multiple brands), and instructions by mail. After taking the medications, participants underwent follow-up testing and had consultations with clinicians by telephone or videoconference to evaluate abortion completeness. Limitations of the study included failure to ascertain abortion outcomes for 23% of the participants treated, the authors note. Thus, "estimates of the proportion with medical abortion failure or complications may thus be underestimated," they write. Few Medical Concerns, but Politics Remain The TelAbortion study shows that telemedicine could improve people's access to safe, legal abortion early in pregnancy, said Julia Kohn, PhD, MPA, national director for research, evaluation, and data analytics for Planned Parenthood Federation of America, in a statement. "While seven in 10 Americans support abortion rights, 90% of US counties have no abortion provider — and telemedicine makes it possible for patients to get the care they need without having to travel long distances," Kohn said. A leading group that is trying to overturn Roe v. Wade, the National Right to Life Committee (NRLC), has been working to block the telehealth approach advocated by Gynuity through what is called a "Web cam abortion ban." NRLC works with its affiliates to block what it calls proabortion laws, Ingrid A. Duran, director of the NRLC's Department of State Legislation, told Medscape Medical News in an email exchange. "So far 20 states have passed a law banning an abortion via telemedicine," Duran said. Randall K. O'Bannon, PhD, director of education and research at the National Right to Life Educational Trust Fund, said his group's objections are based on concerns about safety of abortion, not objections to the practice of telemedicine itself. To support his argument, O'Bannon cited as evidence the FDA's tally of adverse events seen with use of mifepristone for abortion. Since the FDA's 2000 approval of the drug for this use, about 3.7 million women have used mifepristone in the United States, according to the agency. On its Web page about the drug, the FDA said there have been reports of 24 deaths associated with use of the drug, including two cases of ectopic pregnancy resulting in death, as well as several cases of sepsis. Women should not take this drug for abortion if more than 70 days have elapsed since their last menstrual period, according to the FDA. The FDA in 2016 expanded the gestational limit to 70 days from an earlier 49-day cutoff, notes Raymond and other researchers in an article titled "Sixteen Years of Overregulation: Time to Unburden Mifeprex" that was published in the New England Journal of Medicine (NEJM). In the title of the article, "Mifeprex" refers to a brand name of mifepristone. In the NEJM article, Raymond and coauthors note that there was minimal documented experience with medical abortion at the time of the FDA approval of the treatment in 2000. Subsequent experience has shown the treatment to be safe, they write, citing "an estimated Mifeprex-associated mortality rate of about 0.00063%. "In contrast, the background risk of pregnancy-related death among pregnant women in the United States who do not have abortions and instead proceed to live birth is approximately 0.009%, which is 14 times higher," they write in the NEJM article. The FDA's risk evaluation and mitigation strategy for mifepristone is "unnecessary and burdensome," said Bliss Kaneshiro, MD, MPH, a coauthor of the new article in Contraception, in an emailed comment provided to Medscape by the group Physicians for Reproductive Health. Kaneshiro earlier spoke with the New Yorker magazine about the TelAbortion project, explaining its potential advantages for women living on Hawaiian islands who experience difficulty reaching clinics. "I was worried that the video visits wouldn't be as personal as they are in the office, but I've found it's very personal," Kaneshiro told the New Yorker . "I get to glimpse into people's lives. I see kids in the background and a partner listening. I see patients in their bedrooms. I get a sense of how this is playing out in their lives." The results of the TelAbortion study support further use of this approach, according to Kaneshiro. "Our experience with this study has convinced us that telemedicine is a great tool to assist women in accessing abortion care," Kaneshiro told Medscape via email. "Being able to mail mifepristone allowed patients to overcome geographic barriers and access effective care." Source
