DOI: 10.7272/q67h1ggv
title: Comparison of Outcomes before and after Ohio's Law Mandating Use of the FDAApproved Protocol for Medication Abortion: A Retrospective Cohort Study

description: 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 &lt; 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 &lt; 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.