Medication abortion use among low-income and rural Texans before and during state-imposed restrictions and after FDA-updated labeling





Background


In 2013, the Texas legislature passed House Bill 2, restricting use of medication abortion to comply with Food and Drug Administration labeling from 2000. The Food and Drug Administration updated its labeling for medication abortion in 2016, alleviating some of the burdens imposed by House Bill 2.


Objective


Our objective was to identify the impact of House Bill 2 on medication abortion use by patient travel distance to an open clinic and income status.


Materials and Methods


In this retrospective study, we collected patient zip code, county of residence, type of abortion, family size, and income data on all patients who received an abortion (medication or aspiration) from 7 Texas abortion clinics in 3 time periods: pre−House Bill 2 (July 1, 2012−June 30, 2013), during House Bill 2 (April 1, 2015−March 30, 2016), and post−Food and Drug Administration labeling update (April 1, 2016−March 30, 2017). Patient driving distance to the clinic where care was obtained was categorized as 1−24, 25−49, 50−99, or 100+ miles. Patient county of residence was categorized by availability of a clinic during House Bill 2 (open clinic), county with a House Bill 2−related clinic closure (closed clinic), or no clinic any time period. Patient income was categorized as ≤110% federal poverty level (low-income) and >110% federal poverty level. Change in medication abortion use in the 3 time periods by patient driving distance, residence in a county with an open clinic, and income status were evaluated using χ 2 tests and logistic regression. We used geospatial mapping to depict the spatial distribution of patients who obtained a medication abortion in each time period.


Results


Among 70,578 abortion procedures, medication abortion comprised 26%, 7%, and 29% of cases pre−House Bill 2, during House Bill 2, and post−Food and Drug Administration labeling update, respectively. During House Bill 2, patients traveling 100+ miles compared to 1− 24 miles were less likely to use medication abortion (odds ratio, 0.21; 95% confidence interval, 0.15, 0.30), as were low-income compared to higher-income patients (odds ratio, 0.76; 95% confidence interval, 0.68, 0.85), and low-income, distant patients (adjusted odds ratio, 0.14; 95% confidence interval, 0.08, 0.25). Similarly, post−Food and Drug Administration labeling update, rebound in medication abortion use was less pronounced for patients traveling 100+ miles compared to 1−24 miles (odds ratio, 0.82; 95% confidence interval, 0.74, 0.91), low-income compared to higher-income patients (odds ratio, 0.77; 95% confidence interval, 0.72, 0.81), and low-income, distant patients (adjusted odds ratio, 0.80; 95% confidence interval, 0.68, 0.94). Post−Food and Drug Administration labeling update, patients residing in counties with House Bill 2−related clinic closures were less likely to receive medication abortion as driving distance increased (52% traveling 25−49 miles, 41% traveling 50−99 miles, and 26% traveling 100+ miles, P < .05). Geospatial mapping demonstrated that patients traveled from all over the state to receive medication abortion pre−House Bill 2 and post−Food and Drug Administration labeling update, whereas during House Bill 2, only those living in or near a county with an open clinic obtained medication abortion.


Conclusion


Texas state law drastically restricted access to medication abortion and had a disproportionate impact on low-income patients and those living farther from an open clinic. After the Food and Drug Administration labeling update, medication abortion use rebounded, but disparities in use remained.


Although the overall abortion rate in the United States is declining, medication abortion use has increased steadily. In 2014, approximately 31% of abortions in the United States were induced via medication, compared to 6% in 2001. Patients choose medication abortion because of a desire to avoid an aspiration procedure, a belief that it is more natural given its similarity to miscarriage, and because the process can occur in the privacy and comfort of one’s home.



AJOG at a Glance


Why was this study conducted?


To evaluate the impact of a Texas legislative restriction on medication abortion among low-income patients and those living far from an open clinic.


Key findings


Compared to the year prior to implementation of the law, while the law was in effect, medication abortion use declined for all patients, but more so for low-income patients and those driving 100+ miles for care. After the FDA updated labeling for medication abortion, use of this method increased overall, but less so for low-income patients and those driving 100+ miles for care.


What does this add to what is known?


Our findings of reduced medication abortion use in Texas during implementation of the law with a rebound after the FDA updated labeling are consistent with findings from 1 other study. We expand upon existing literature by quantifying the impact on low-income patients and those who had to travel far distances to obtain care.



Despite the increasing demand for medication abortion, legislation in some states requiring adherence to the US Food and Drug Administration (FDA) labeling has limited its use. In 2000, the FDA approved use of mifepristone, along with misoprostol administered at a healthcare facility 48 hours later, to end pregnancy up to 7 weeks’ gestation. Since its initial approval, evolving research on medication abortion demonstrated that effectiveness in inducing complete abortion was maintained up to 10 weeks’ gestation and that patients could safely self-administer misoprostol between 24 and 48 hours after taking mifepristone. As a result, a newer evidence-based medication abortion regimen was widely used across the United States that diverged from the initial FDA labeling.


In July 2013, the Texas state legislature passed House Bill 2 (HB2) requiring physicians to provide medication abortion in accordance with the 2000 FDA label. All patients seeking care between 7 and 10 weeks’ gestation were prevented from obtaining medication abortion. In addition, for most patients in Texas seeking medication abortion, this law required an increase from 3 to 4 in-person visits for the following: (1) state-mandated counseling and sonographic confirmation of gestational age; (2) administration of mifepristone at least 24 hours later; (3) administration of misoprostol in the clinic 48 hours after mifepristone use; and (4) an in-person follow-up visit 7−14 days later. Patients living more than 100 miles from any open clinic could complete the process in 3 visits if they received state-mandated counseling via telephone 24 hours prior to receiving mifepristone. Medication abortion became more difficult to obtain compared to aspiration abortion, which could be completed in 2 visits (1 visit for patients living more than 100 miles from any clinic who also completed the state-mandated telephone counseling 24 hours in advance).


Simultaneously, other components of HB2 that required physicians providing abortion to have hospital admitting privileges and all abortion clinics to meet the facility requirements of an ambulatory surgical center (ASC) led to closure of more than one-half of the state’s abortion clinics, as well as long delays to obtain an initial appointment in clinics that remained open. Previous research demonstrated that although there was a statewide decrease in the abortion rate by 13%, use of medication abortion decreased by 70% as a result of this restrictive Texas law. , , ,


In March 2016, the FDA updated its labeling allowing mifepristone use up to 10 weeks’ gestation and home administration of misoprostol 24 to 48 hours later, thus minimizing the impact of Texas legislative restrictions and resulting in a rebound of medication abortion use statewide.


Legislative restrictions against abortion may disproportionately prevent rural and low-income patients from accessing abortion, yet there is limited research on the impact of these laws among these groups. , Although the statewide impact of HB2 has been described, our objective was to identify the impact of this law on medication abortion use by patient travel distance to an open clinic and income status.


Materials and Methods


Procedures


In this retrospective study, we collected data from 7 abortion clinics that were open in 3 time periods: pre-HB2 (July 1, 2012, to June 30, 2013); during HB2 (April 1, 2015, to March 30, 2016); and after the FDA labeling update (April 1, 2016, to March 30, 2017). Data were not collected for the year immediately following passage of HB2, given the flux in abortion clinic availability resulting from a rapidly evolving legal climate ( Figure 1 ). Six of the 7 clinics included in this study began providing medication abortion consistent with the updated FDA labeling on April 1, 2016; the other clinic began the following month.




Figure 1


Study period timeline and corresponding policy changes

Goyal et al. Medication Abortion in Texas. Am J Obstet Gynecol 2020.


When we began this study, the ASC requirement enacted in HB2 was in legal limbo in a series of injunctions blocking enforcement of this requirement and lifting of injunctions allowing it to go in effect. We aimed to include data from clinics that met ASC requirements, 6 of the 41 existing Texas abortion clinics, that would be open in all 3 study periods if this component of the law was upheld. We ultimately collected data from 5 clinics that met ASC requirements, as well as their 2 affiliated clinics, including 2 abortion clinics in Dallas and 1 each in Fort Worth, Austin, San Antonio, Houston, and McAllen. We were unable to collect data from the sixth clinic meeting ASC requirements, which was located in Houston. In June 2016, the US Supreme Court ruled both the ASC and admitting privilege requirements unconstitutional. Therefore, the 7 abortion clinics included in this study were among 18 that were open at some point during the latter 2 study periods, representing approximately 50% of abortions performed in the state and including all cities with an open ASC during HB2.


Each clinic generated a de-identified list of all patients who obtained an abortion (medication or aspiration) during each time period, along with the patient zip code, patient county of residence, family size and income, type of abortion, and weeks’ gestation at time of care from their electronic medical record databases. We calculated whether each patient met criteria for funding assistance for abortion, defined as living at or below 110% of the federal poverty level from all clinics except Houston, which did not keep an electronic record of patient income.


The study protocol was approved by the University of Texas at Austin institutional review board as well as by the research department of participating clinics, if in existence, prior to data collection.


Statistical analysis


To evaluate the association between patient travel distance and medication abortion use by time period, we calculated the driving distance between the centroid latitude and longitude coordinates of the patient’s zip code and that of the clinic where care was received using Google API. Patient driving distances were then categorized as 1−24, 25−49, 50−99, or 100+ miles from the clinic. Patients residing outside of Texas were excluded from this analysis.


For the Houston clinic in the pre-HB2 time period, only county code information was available for each patient. We identified counties containing zip codes that fell into disparate driving distance categories as described above. Of these, the greatest number of patients came from Harris County (77%), in which the Houston clinic is located. We assigned patient travel distances for these counties to align with the distribution seen during HB2 (eg, 80% of patients from Harris county resided in areas with zip codes that were 1−24 miles from the clinic, and 20% lived 25−49 miles from the clinic). Given the potential misclassification of driving distances, we also analyzed our results when patients traveling from these counties were categorized into the shortest and longest travel distances to establish a lower and upper range of possible values, respectively.


During HB2, medication abortion use was likely affected directly by legislative restrictions and indirectly by clinic closures related to the physician admitting privileges and ASC requirement components of the law. To evaluate the association between clinic closures and medication abortion use, we categorized patients as living in a county with an open clinic in all 3 time periods (Bexar, Dallas, El Paso, Harris, Hidalgo, Tarrant, and Travis counties) and those living in a county with an HB2-related clinic closure (Bell, Brazos, Cameron, Jefferson, Lubbock, McLennan, Midland, Nueces, and Tom Green counties). We also compared medication abortion use in the during HB2 and post−FDA update time periods, when the number of clinics in Texas was relatively stable, to isolate the impact of legislative restrictions on medication abortion from clinic closures.


To examine differences in medication abortion use in each of the 3 time periods, we calculated the number of patients who received medication abortion among all abortion patients and presented the raw numbers and proportions overall and by patient driving distance to the clinic, residence in a county with an open or closed clinic, and federal poverty level. To account for differences in medication abortion use related to legislative restrictions, separate from clinic closures, we reported the number of medication abortion users among all abortion patients, by patient county of residence, and by patient federal poverty level in the during-HB2 and post−FDA update periods stratified by patient driving distance. We conducted χ 2 tests of association to evaluate the relationship between medication abortion use and patient driving distance to a clinic, residence in a county with a clinic that remained open, and federal poverty level by time period. We also calculated odds ratios and 95% confidence intervals to evaluate medication abortion use among those traveling a short compared to longer distances, living in a county with compared to without an open clinic, and higher compared to low-income patients for each time period. We then created logistic regression models to examine the relationship between medication abortion use and patient county of residence, as well as income status, adjusted for patient driving distance in the latter 2 time periods. Quantitative analyses were conducted using STATA version 14 (StataCorp, College Station, TX).


To depict the spatial distribution of patients who received a medication abortion from our study clinics during each of the 3 time periods, we used ArcGIS version 10.6. Choropleth maps were created for each time period in which counties were shaded in proportion to the total number of patients per county who received medication abortion. Overlaying these maps are the cities in which there was an open abortion clinic or HB2-related clinic closure.


Finally, we used the updated FDA labeling for mifepristone use up to 10 weeks’ gestation to determine how many patients were eligible by gestational age at time of care for this abortion method. We calculated the proportion of medication abortion users among all patients who obtained care at or less than 10 weeks’ gestation in the during HB2 and post−FDA labeling update time periods. We used these calculations to estimate the proportion of patients who were unable to use medication abortion because of HB2-imposed restrictions.


Results


We collected data from 21,626 abortion cases from the pre-HB2 period, 23,126 during HB2, and 25,826 in the year post−FDA updated labeling for medication abortion.


Among patients who presented for abortion care at our study clinics, 26% received medication abortion pre-HB2, compared to 7% during HB2 and 29% after the FDA labeling update ( Table 1 ). When evaluating the association of patient travel distance on medication abortion use, we found a similar pattern of reduced medication abortion use during HB2 compared to pre-HB2 in each patient driving distance category. Yet, patients traveling more than 100 miles were significantly less likely to obtain medication abortion compared to those traveling 1−24 miles for care during HB2. In each driving distance category, medication abortion use increased in the post−FDA labeling update period compared to during HB2; yet, again, this increase was less pronounced for patients traveling 100+ miles for care compared to those traveling 1−24 miles.


Aug 9, 2020 | Posted by in GYNECOLOGY | Comments Off on Medication abortion use among low-income and rural Texans before and during state-imposed restrictions and after FDA-updated labeling

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