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It’s time to make oral contraceptives available without a prescription

Jeffrey A. Singer, MD
Meds
January 2, 2018
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At his recent confirmation hearing, Alex Azar, President Trump’s nominee for secretary of Health and Human Services, was grilled by senators who wanted to know where he stands on requiring employers to provide oral contraception coverage in their employee health plans — even if employers object on religious or moral grounds. While avoiding specifics, Azar committed himself to finding a balance between making contraceptives affordable and available to women, and respecting “the conscience of their employers.”

Lost in the back and forth was the opportunity to ask Azar if he would press the Food and Drug Administration to let the U.S. join the 102 countries that currently allow birth control pills to be sold over the counter without a prescription.

The American College of Obstetricians and Gynecologists (ACOG) has called for making birth control pills available without a prescription for many years; its Committee on Gynecologic Practice reiterated that opinion in 2012. The American Academy of Family Physicians agrees. And a 2015 survey of nearly 500 reproductive health care providers found that 74 percent of them supported expanding access to oral contraceptives.

In response to concerns that women may forgo necessary preventive care visits if birth control pills are available over the counter, ACOG states that “cervical cancer screening or sexually transmitted infection (STI) screening is not required for initiating OC [oral contraceptive] use and should not be used as barriers to access.” In fact, there is currently a debate among gynecologists regarding the need and benefits of annual pap exams.

Another worry has been that women may misuse oral contraceptives without pre-screening by a health care professional. But OTC advocates point to a 2006 report from Seattle showing women’s self-evaluation regarding whether or not they should take the pill matched those of doctors about 90 percent of the time — and the 10 percent of the time they didn’t match was mostly because the women erred on the side of caution.

In light of this medical consensus, it is patronizing to still require women to get an exam and what amounts to a permission slip from a health care practitioner in order to get oral contraceptives. Men certainly don’t have to get a men’s wellness exam and a prescription for condoms.

The prescription status of birth control pills also places a financial burden on women. Leaving work or home to wait in a doctor’s office for a prescription costs time and money.

Several states have tried to work around the FDA’s prescription classification by allowing pharmacists to prescribe birth control pills. While that’s an improvement over the status quo, it still negatively affects women’s comfort and privacy. As shown in a 2015 report in the journal Sexual and Reproductive Healthcare, many women who seek emergency contraception (the so-called morning after pill, which has been available over-the-counter since 2006) prefer to purchase this kind of medication discreetly and avoid unwanted discussion or counseling, even if offered by a health care professional.

The obstacles created by the prescription status of oral contraceptives may be one reason why many women stop taking them after just one year. Removing these obstacles may help women take oral contraceptives longer and thus prevent unwanted pregnancies. In its 2012 call to reclassify birth control pills as nonprescription drugs, ACOG cites research from the University of Texas that compared the use of oral contraceptives across the U.S.-Mexico border at El Paso/Ciudad Juarez — oral contraceptives are available over the counter in Mexico. The researchers concluded that providing users of oral contraceptive pills “with more pill packs and removing the prescription requirement would both lead to increased continuation.”

Finally, prices of oral contraceptives, which currently average between $20 to $50 per month but range as low as $9 per month, might come down further once they can be sold over the counter and are rendered vulnerable to greater competition and consumer scrutiny.

According to FDA regulations, a petition to reclassify a drug from prescription to nonprescription/over-the-counter status can come from a manufacturer, any “interested party,” or the FDA commissioner. Congress can also legislate reclassification.

With heath care costs continuing to climb, with many people living paycheck to paycheck, and with the health care professions united in their call to make oral contraceptives available without a prescription, it is lamentable that the senators questioning Azar at his confirmation hearing didn’t dive into this matter. If he’s confirmed, I hope he will do the right thing and lift this burden off of millions of American women.

Jeffrey A. Singer is a general surgeon. This article originally appeared in STAT News.

Image credit: Shutterstock.com

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