Comparison of Outcomes before and after Ohio's Law Mandating Use of the FDA-Approved Protocol for Medication Abortion: A Retrospective Cohort Study

Abstract

Background

In February 2011, an Ohio law took effect mandating use of the United States Food and Drug Administration (FDA)-approved protocol for mifepristone, which is used with misoprostol for medication abortion. Other state legislatures have passed or enacted similar laws requiring use of the FDA-approved protocol for medication abortion. The objective of this study is to examine the association of this legal change with medication abortion outcomes and utilization.

Methods and Findings

We used a retrospective cohort design, comparing outcomes of medication abortion patients in the prelaw period to those in the postlaw period. Sociodemographic and clinical chart data were abstracted from all medication abortion patients from 1 y prior to the law’s implementation (January 2010–January 2011) to 3 y post implementation (February 2011–October 2014) at four abortion-providing health care facilities in Ohio. Outcome data were analyzed for all women undergoing abortion at ≤49 d gestation during the study period. The main outcomes were as follows: need for additional intervention following medication abortion (such as aspiration, repeat misoprostol, and blood transfusion), frequency of continuing pregnancy, reports of side effects, and the proportion of abortions that were medication abortions (versus other abortion procedures). Among the 2,783 medication abortions ≤49 d gestation, 4.9% (95% CI: 3.7%–6.2%) in the prelaw and 14.3% (95% CI: 12.6%–16.0%) in the postlaw period required one or more additional interventions. Women obtaining a medication abortion in the postlaw period had three times the odds of requiring an additional intervention as women in the prelaw period (adjusted odds ratio [AOR] = 3.11, 95% CI: 2.27–4.27). In a mixed effects multivariable model that uses facility-months as the unit of analysis to account for lack of independence by site, we found that the law change was associated with a 9.4% (95% CI: 4.0%–18.4%) absolute increase in the rate of requiring an additional intervention. The most common subsequent intervention in both periods was an additional misoprostol dose and was most commonly administered to treat incomplete abortion. The percentage of women requiring two or more follow-up visits increased from 4.2% (95% CI: 3.0%–5.3%) in the prelaw period to 6.2% (95% CI: 5.5%–8.0%) in the postlaw period ( p = 0.003). Continuing pregnancy was rare (0.3%). Overall, 12.6% of women reported at least one side effect during their medication abortion: 8.4% (95% CI: 6.8%–10.0%) in the prelaw period and 15.6% (95% CI: 13.8%–17.3%) in the postlaw period ( p < 0.001). Medication abortions fell from 22% (95% CI: 20.8%–22.3%) of all abortions the year before the law went into effect (2010) to 5% (95% CI: 4.8%–5.6%) 3 y after (2014) ( p < 0.001). The average patient charge increased from US$426 in 2010 to US$551 in 2014, representing a 16% increase after adjusting for inflation in medical prices. The primary limitation to the study is that it was a pre/post-observational study with no control group that was not exposed to the law.

Conclusions

Ohio law required use of a medication abortion protocol that is associated with a greater need for additional intervention, more visits, more side effects, and higher costs for women relative to the evidence-based protocol. There is no evidence that the change in law led to improved abortion outcomes. Indeed, our findings suggest the opposite. In March 2016, the FDA-protocol was updated, so Ohio providers may now legally provide current evidence-based protocols. However, this law is still in place and bans physicians from using mifepristone based on any new developments in clinical research as best practices continue to be updated.

Abstract

In this retrospective cohort study, Ushma Upadhyay and colleagues compare outcomes from medication abortions performed in Ohio before and after a law mandating use of the FDA-approved protocol.

Author Summary

Why Was This Study Done?

• An Ohio law went into effect in 2011 that required abortion providers to use a protocol for medication abortion that had been approved by the US Food and Drug Administration (FDA) in 2000.

• This protocol conflicted with the protocol supported by several international guidelines and used by most abortion providers throughout the US.

• The protocol approved by the FDA in 2000 required a higher, more expensive dose of oral mifepristone, a lower dose of oral misoprostol administered only at a provider’s office 48 h later, and limited use up to 49 d after a woman’s last menstrual period.

• This research was conducted to explore the abortion outcomes for women who received medication abortion before the 2011 law went into effect compared with outcomes after the law was in place.

What Did the Researchers Do and Find?

• Using chart data from 2,783 women who obtained a medication abortion between 2010 and 2014 collected retrospectively from four clinics in Ohio, we examined the proportion of women who received an additional medical intervention to complete the abortion, the experience of side effects, and the rate of medication abortion versus aspiration abortion in Ohio.

• The data showed that women who had medication abortions in the postlaw period were three times as likely to need additional interventions to complete their abortion compared to women in the prelaw period.

• In addition, side effects such as nausea and vomiting were significantly more likely among women after the law change, and there was an 80% decline in medication abortion in Ohio between 2010 and 2014.

What Do These Findings Mean?

• These results suggest that after the 2011 law was enacted, there was a greater need for additional intervention, as well as more visits, more side effects, and higher costs for women compared to before the law.

• Although the FDA updated the medication abortion protocol in March 2016 to match the evidence, this protocol may also become outdated in the future, and health providers in Ohio will be required to provide care based on legislation, rather than the most up-to-date research and evidence-based practice.