We have seen that the time is right to transform how we access health care. The fact that abortion has been a major part of our health care system has made it clear that many people are unable to afford it. The science behind medication abortion is reliable and effective. It is time to eliminate restrictions. The FDA's actions and new research have shown that medication abortion care can be removed. This could increase access for many who are in need. Contraception's July 2021 special issue focuses on restrictions on medication abortion, such as mifepristone. It also discusses its effects on safety and efficacy, access, and the burdens on providers and patients.
Mifepristone is controlled by a Risk Evaluation and Mitigation Strategy. REMS programs are not common and only for drugs that have a high risk of side effects. Three elements make up the mifepristone REMS: Providers must register as certified prescribers and patients must sign a patient consent form. These restrictions together create the impression that mifepristone can be dangerous for patients and too complicated for health care providers.
The vast amounts of data that were collected over the first 20 years in America about mifepristone's use have shown it to be extremely effective and safe. Before 2020, opponents to loosening regulations on Mifepristone might argue that it was safe for nearly four million people who used it in the U.S. due to the regulations. However, the COVID-19 pandemic has shown that restrictions do not make mifepristone safer.
To limit contact with patients, the requirement that mifepristone be administered in person was removed during the pandemic. After a telehealth assessment, providers were able to mail mifepristone to patients by post. Both patients received the care and counseling they required, while health care providers collected all the information necessary to determine whether mifepristone was a suitable option. This avoided COVID-19. This allowed us to examine how the removal of this requirement affected or did not impact the safety and efficacyof medication abortion care.
The Contraception special issue contains two articles that describe the different methods of medication abortion care in the U.S., which include telehealth visits followed by mailed medications. Both authors find these protocols to be safe (less than 1% of patients had to experience a serious complication) as well as effective (95 percent had a successful abortion and there was no follow-up procedure). The U.K. has shown that medication abortion care via telehealth or mailed medications is safe, efficient, and very popular with patients. These studies, taken together, confirm what we knew from pre-COVID-19: Mifepristone is safe, effective, no matter how or where it is administered.
Health care providers are not allowed to provide medication abortion care if they have to comply with medically unjustified restrictions. A survey found that 24 percent of obstetrician-gynecologists not currently providing medication abortion care would do so if the in-person dispensing requirement were removed, potentially more than doubling the number of providers in the Southeast and Midwest, where abortion access is highly restricted. The REMS is preventing many patients from receiving abortion care from their primary care provider.
While medication abortion care falls within primary care's purview, the REMS can cause stigmatization and other barriers at both the institutional and individual level. The REMS presents logistical problems (including the requirement for in-person dispensing) and institutional resistance that can create barriers for providers as well as unnecessary burdens for patients. The REMS could be removed and pharmacy dispensing of Mifepristone allowed. This would normalize abortion care, improve primary care, and reduce disparities in access to abortion.
Telemedicine abortion with mailed medication is a popular option for patients. Patients describe their concerns about privacy, stigma protection, and avoiding unnecessary contacts. This is especially important during COVID. A survey of 45 patients from Hawaii found that 13 percent would not have chosen telemedicine without mailed medications. Access to abortion care via telehealth is crucial for increasing access. Providers can reach distant patients and one provider can provide services in all 50 states without the need to travel.
Each year that has passed since the approval in 2000 of mifepristone, the amount of research supporting its safety and effectiveness grows. There is plenty of high-quality data available to support a review of how mifepristone should be regulated. We also have the ability to take out the REMS. This will not solve the problem of abortion access due to the many restrictions placed by states, but it is a necessary step towards bringing medication-abortion care in line with science. It is time.
This article is an opinion/analysis article. Scientific American does not necessarily endorse the views expressed in it.
