Abortion patients face more complications and side effects after 2011 Ohio law

Women having medication abortions after the law went into effect were three times as likely to need additional treatment.

In 2011, the state of Ohio passed a law requiring abortion providers to administer medication abortions according FDA guidelines. That sounds reasonable, but there’s a problem: those guidelines were woefully out-of-date. Abortion providers across the country had since updated their practices to reflect current research and achieve a better standard of care for their patients. Abortion providers say the regulations were an attempt on the part of lawmakers to restrict women's access to their services. In a study published in PLOS, Ushma Upadhyay of the UCSF School of Medicine, looks at the data to investigate how this law affected women undergoing abortions in Ohio after it was passed. We asked her about her findings.

ResearchGate: Could you briefly introduce the 2011 Ohio law your study concerns itself with?

Ushma Upadhyay: I should start earlier in time, in 1997, when the US Food and Drug Administration (FDA) first received the application for approval of mifepristone, one of the drugs required for a medication abortion. The application contained the best evidence from clinical trials available at that time. It was a lengthy and politically-charged review process that took 54 months. In 2000, the FDA approved medication abortion. Since that approval, clinical trials have been ongoing. Researchers were examining modifications to this initially approved regimen, studying alternative dosages of the drugs and timing and route of administration to improve success rates for medication abortion. By 2011, abortion providers across the United States had been using what is called the “evidence-based regimen,” which was based on published research, although the FDA label had not yet been updated.  So this “off-label” regimen was the standard of care.

In 2011, Ohio enacted a law that required abortion providers to use the FDA protocol as it was approved in 2000.  When I heard about Ohio’s law in 2013 at an academic conference, I was surprised. While on the face of it, it sounds like a reasonable law, in practice the FDA doesn’t constantly keep guidelines updated for every medication on the market. I wondered what the outcomes would be for women and thought this had to be studied.

RG: Why hadn’t the FDA recommendations been updated to reflect more recent research?

Upadhyay: This is not my area of expertise, but I believe that the FDA updates its label only when the drug maker puts in an application requesting the FDA to review the latest scientific evidence.

RG: What were your results?

Upadhyay: We conducted a retrospective cohort study among almost 3,000 women obtaining a medication abortion at one of four Ohio abortion facilities, comparing several outcomes before and after the law. Our main outcome was looking at the need for additional medical treatments to complete the course of care. We also looked at number of visits and side effects. Additionally, we collected health care facility-level data to look at overall changes including number of medication abortion patients and patient charges.

We found that women who had medication abortions in the post-law period had three times the odds of requiring at least one additional treatment compared to women in the pre-law period. We also found increases in the number of visits, in the percentage experiencing side-effects, and in average patient charges after the law was enacted.

RG: What kinds of additional treatment did these women need?

Upadhyay: The most common medical treatment was another dose of misoprostol, the second drug used in a medication abortion. The next most common was an in-clinic aspiration procedure—this is the very procedure women were trying to avoid by opting for a medication abortion.

RG: Were abortion providers in other states not bound by these outdated FDA regulations?

Upadhyay: No, abortion providers around the country were using the updated guidelines for years, which is why the drug maker had little incentive to put in an application requesting the FDA to update its label. It is common practice for health care providers to prescribe medications off-label based on the latest scientific evidence.

RG: Is the FDA protocol from 2000 still in place?

Upadhyay: The FDA updated its label for medication abortion in March, 2016. Now abortion providers in Ohio can legally offer the method based on the protocol supported by current research. However, the law is still in place, requiring providers to adhere to practices that were current in March, 2016.

The current FDA label is pretty good. It conforms with the way most providers offer patients medication abortion. And it says qualified health care providers, such as nurse practitioners, can provide medication abortion to their patients. It does, however, still require providers be registered with the company and also does not allow medications to be distributed by pharmacies.

RG: Does that mean the negative impact your study outlines is no longer an issue?

Upadhyay: Although the FDA has now updated the regimen for medication abortion to bring it in line with the current evidence, it too will eventually become out-of-date. For example, clinical trials that test the safety of pharmacy access are currently underway. Similarly, clinical trials are now exploring the potential of increasing the gestational limit, testing safety and efficacy of medication abortion regimens up to 77 days from a woman’s last menstrual period. This law will continue to require physicians to provide care that may fall below the accepted standard, and women in Ohio will not be able to avail themselves of the latest developments in research on medication abortion.

Featured image courtesy of Julep67.