National Partnership for Women & Families

Monthly Women's Health Research Review

Ohio medication abortion law curbed access, worsened health outcomes, study finds

Summary of "Comparison of outcomes before and after Ohio's law mandating use of the FDA-approved protocol for medication abortion: A retrospective cohort study," Ushma Upadhyay et al., PLOS Med, Aug. 30, 2016.

Since the Food and Drug Administration (FDA) in 2000 first approved a medication abortion regimen, providers have been using alternative regimens based on best practices, according to Ushma Upadhyay of the University of California-San Francisco's Advancing New Standards in Reproductive Health and colleagues.

The original FDA regimen required a "higher, more expensive dose of oral mifepristone, a lower dose of oral misoprostol administered only at a provider's office 48 hours later, and limited use up to 49 days after a woman's last menstrual period" (LMP). However, providers have routinely administered an evidence-based regimen that includes a lower, less costly dose of oral mifepristone and a higher dose of misoprostol up to 70 days after LMP. According to the researchers, "these evidence-based regimens have higher effectiveness rates (95-99 percent) than the regimen approved by the FDA in 2000 (88-92 percent)."

In 2011, Ohio implemented a law that forced providers to adhere to FDA protocol, which at the time meant that providers had to comply with the outdated 2000 regimen. However, "[i]n response to the growing body of clinical evidence, the FDA approved a revised label in March 2016 to bring the medication abortion protocol in line with the off-label prescribing of mifepristone and misoprostol that had become the standard of care," the researchers wrote. They noted that as a result, "[i]n the three states where the law is in effect, including Ohio, abortion providers can now legally offer patients medication abortion based on the currently available evidence as long as new research does not further improve clinical best practices."

For the study, the researchers "examine[d] whether the 2011 Ohio law change from an evidence-based regimen...to the FDA regimen (as approved in 2000) was associated with the need for additional intervention following medication abortion." They also assessed "the number of follow-up visits, continuing pregnancy rate, experience of side effects, proportion of medication abortions...and average patient charges for medication abortion."

Methods

The researchers looked at administrative data as well as "sociodemographic and clinical chart data for all medication abortion patients" from "four abortion-providing facilities in Ohio."

The researchers used the administrative data to determine "the total number of abortions and total number of medication abortions from all four sites for each year between 2010 and 2014." The researchers also assessed "average patient pricing for medication abortion in 2010 and 2014." For the study, the researchers also took into account any need for additional intervention or adverse event diagnoses following the medication abortion.

Results

The researchers had a final sample of 2,783 patient charts, including 1,156 prelaw and 1,627 postlaw. The researchers found that while "[t]here were significant differences between the prelaw and postlaw populations in this sample by education, race, insurance status, gestation, and number of previous births," there were not significant differences "by age, distance travelled, BMI, or site visited." Overall, the researchers found that 86 percent of the women traveled less than 50 miles for abortion care and 13 percent traveled at least 50 miles.

Need for additional intervention

The study found that women in the postlaw period (14.3 percent) were three times more likely than those in the prelaw period (4.9 percent) to require an additional intervention following their medication abortion.

The researchers also identified certain characteristics among women that required additional interventions. According to the researchers, women covered through Medicaid were more likely than those with private insurance to require additional interventions. Meanwhile, women with at least a college-level education were less likely than those without a college education to require additional medical attention.

Intervention types and adverse event diagnoses

The researchers found that 96 percent of women overall reported no adverse events, including 98 percent of women in the prelaw period and 95 percent of women in the postlaw period. According to the researchers, for the small percentage of women who did report an adverse event, the percentage was higher after the 2011 law (3.2 percent postlaw in comparison to 2.4 percent prelaw). The researchers found that "[a]n additional 7 percent of all women had no adverse event recorded but [still] received a subsequent intervention" (3.2 percent prelaw and 9 percent postlaw).

Follow-up visits

According to the researchers, similar percentages of patients failed to complete a follow-up visit in the prelaw period (27.9 percent) and the postlaw period (28 percent). The researchers found several demographic characteristics linked with not following up across both time periods, including having to travel at least 50 miles to access care, having Medicaid coverage and having at least one prior birth.

In addition, the researchers found that "the percentage of women requiring two or more follow-up visits increased from 4.2 percent...in the prelaw period to 6.8 percent...in the postlaw period."

Side effects

The researchers found that 12.6 percent of women overall reported at least one side effect, increasing from 8.4 percent prelaw to 15.6 percent postlaw. According to the researchers, "The most common reported side effects were nausea and/or vomiting (7.4 percent of women)." About 6 percent reported "other side effects."

Trends in medication abortion

Based on clinics' administrative data, the researchers found "an overall decline in the proportion of abortions that were medication abortions." According to the researchers, the proportion of medication abortions declined from 22 percent in 2010 to 7 percent in 2011, 6 percent in 2012, 6 percent in 2013 and 5 percent in 2014. They added that one clinic stopped offering medication abortion between the law's implementation in 2011 and January 2013.

The researchers also found that "[t]he average patient charge for medication abortion rose from US$426 to US$551 between 2010 and 2014, representing a 29 percent increase in nominal dollars."

Discussion

"This study finds that while the provision of medication abortion was still safe and effective in Ohio, the 2011 law change was associated with greater need for additional intervention, more visits, more side effects, and higher costs for women who have medication abortions," the researchers wrote. Further, according to the researchers, the decline in medication abortions as a proportion of abortion care offered in Ohio after the 2011 law counters "national trends, where medication abortion is increasing as a proportion of all abortions."

The researchers explained that "[t]he law increased the logistical burdens on women who have medication abortions," including travel-associated costs under the four-visit requirement. Moreover, the number of abortion providers in Ohio declined from 14 to eight over the last few years, and some providers opted to stop offering medication abortion care under the law. As a result, women seeking medication abortion had to travel farther for care, with some experiencing side effects immediately before heading home because of the in-office medication administration requirement. The researchers added that the outdated medication regimen the 2011 law put into place could account for the increased rate of side effects for women postlaw.

The researchers also highlighted the findings showing that women covered through Medicaid were less likely to report additional interventions, noting that the discrepancy "is likely explained by differences in socioeconomic status and the ability to pay for additional health care." They noted that Ohio's Medicaid program does not cover most abortion care, meaning that women might be reluctant to follow up with a provider for fear of incurring additional costs or might opt instead to follow up at an emergency department.

In addition, the researchers noted that "a larger proportion of women in the postlaw period were having abortions at 42-49 days," perhaps because they faced a shorter gestational limit under the law. Women might also have experienced delays accessing care, since clinics had to accommodate additional visits in the postlaw period.

The researchers wrote that while "the original FDA-approved protocol was recently updated to bring it in line with current evidence, best practices will continue to be updated, and laws like Ohio's prohibit clinicians from practicing medicine based on the latest developments in clinical research." For instance, the researchers cited ongoing research on the safety of pharmaceutical access to medication abortion and extending medication abortion use through 77 days LMP. Pending such research, Ohio's law "will continue to require physicians to provide care that may fall below the accepted standard of care, placing them in an ethical dilemma."

The researchers concluded, "There is no evidence that the change in [the Ohio] law led to improved abortion outcomes. Indeed, our findings suggest the opposite."