Women who had medication abortions were more likely to require additional interventions following implementation of an OH law that required abortion providers to adhere to an outdated protocol, according to a study published by Ushma Upadhyay from the University of California, San Francisco, US, and colleagues in PLOS Medicine.
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To see the impact that the law had on patients, researchers analyzed the medical records of 2,783 women at one of four clinics in OH between 2010 and 2014 who had medication abortions.
To get a medication abortion in OH, you had to go to a doctor four times and had to take a larger dosage. Within a few years, however, doctors realized that using a lower dose of mifepristone and a higher dose of misoprostol produced better outcomes for their patients. Research has since found different dosages and timing are safer – most OH doctors had already made those adjustments before the law was passed.
The practice of prescribing drugs for use “off label” is both legal and commonplace. According to statistics, 21% of all U.S. prescriptions are meant for off-label use.
This law relied on federal drug standards from 2000 to inform 2011 instructions and dosage for the abortion pill mifepristone.
While the FDA has changed its recommendation, should research or medical practice reveal additional improvements to recommended use of the drug before the agency again revises its labeling, UCSF researchers say women in OH are unlikely to receive state-of-the-art treatment.
Before the law was enacted, about 14 percent of women needed additional treatments – like more medication or aspirations – to end their pregnancy.
Prior to 2011, doctors provided additional intervention of some kind in 4.9% of abortion cases. It typically meant using suction to extract the fetus from the uterus or applying an additional dose of misoprostol.
In addition, the incidence of side effects almost doubled after the law took effect.
The proportion of women experiencing side effects such as nausea and vomiting increased from about 8 percent before the law to about 16 percent afterward. Because medical best practices change more quickly than FDA approval, she added, women who live where these laws are still on the books could, in the future, face a similar gulf between the best care option and what, under the law, doctors are allowed to do. “Also, women opting for medication abortions had more side effects than women before the law”. In part, that’s because the minimum number of required doctor visits rose from three to four.
Upadhyay hopes her research can help show why it’s important that state abortion laws actually do follow medical evidence. “Indeed, our findings suggest the opposite”. The FDA guidelines’ last update was in 2000, which means that abortion providers are legally giving medication based on protocols issued more than a decade ago. It also lowered the recommended dose from 600 to 200 milligrams, which lessens side effects and makes it less costly.
Finally, the new labeling says women can take misoprostol (sold as Cytotec, among other brand names) at home rather than in the presence of a physician. This law also made abortions more complicated and expensive to obtain.
“This law will continue to require physicians to provide care that may fall below the accepted standard of care, placing them in an ethical dilemma”, they wrote. That drew the attention of Supreme Court Justice Anthony Kennedy earlier this year when the court considered two separate Texas abortion restrictions passed at the same time.
“It is ironic because it was passed with the stated intention of protecting women’s health”.
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“On the face of it, it sounds reasonable to require providers to use FDA protocol”, says Dr. Ushma Upadhyay, a professor of obstetrics and gynecology at UCSF and lead author of the study.
