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First over-the-counter birth control pill in the U.S. expands access to contraception

The U.S. Food and Drug Administration approved Opill, a progestin-only birth control pill for over-the-counter access without an age restriction. Opill will soon be available for purchase online and in stores, such as CVS, Walgreens and Walmart.
Courtesy of Perrigo
/
NC Health News
The U.S. Food and Drug Administration approved Opill, a progestin-only birth control pill for over-the-counter access without an age restriction. Opill will soon be available for purchase online and in stores, such as CVS, Walgreens and Walmart.

First over-the-counter birth control pill in the U.S. expands access to contraception
by Rachel Crumpler, North Carolina Health News
March 14, 2024


The first over-the-counter birth control pill available in the U.S. — Opill — will soon be online and in stores, boosting convenience and access to oral contraceptives. This means people will be able to access birth control without a prescription just as easily as they can Tylenol or aspirin.

The move marks a significant change as daily oral contraceptive pills have previously only been available in the United States with a prescription.

Opill, a progestin-only contraceptive pill, is 98 percent effective in preventing pregnancy when used as instructed, according to data submitted to the U.S. Food and Drug Administration. It is available for online ordering and will be in stores like CVS, Walgreens, Target and Walmart in the coming weeks.

A one-month supply will cost about $20, and a three-month supply will cost about $50, according to manufacturer Perrigo’s suggested retail price.

“This is a big win for reproductive health care access,” said Jonas Swartz, an OB-GYN at Duke Health, whose research includes a focus on access to contraception.

Swartz said Opill represents a major — and needed — shift in how to get contraception. He said obtaining a prescription can be an unnecessary barrier. For one, available doctor’s appointments are often months away, which may not align with someone’s need for birth control. He noted that it can be burdensome for some folks to arrange the time off work, child care and transportation needed to go to a doctor’s appointment — or even pay for the visit itself.

Over-the-counter access could lower some of these barriers, Swartz said, providing convenient and safe access to contraception.

“As physicians, we don't need to be the gatekeepers to contraception, and I think [Opill] removes that gate in a really meaningful way,” Swartz said.

Dana Singiser, co-founder of Contraception Access Initiative, a nonprofit working to increase access to contraception, said that over-the-counter access is a “pivotal milestone,” particularly as getting contraception has become a more important consideration amid increased restrictions on abortion.

“As abortion bans are being passed across the country, it is even more important for people to be empowered to not get pregnant if that's what they want,” Singiser said.

Years in the making

Oral contraceptive pills are the most commonly used form of reversible contraception in the United States. Combination progestin and estrogen pills are the most-used type, but progestin-only pills such as Opill come with fewer side effects; estrogen-containing pills have a higher risk of blood clots.

Singiser said reproductive health advocates have pushed for over-the-counter access to these pills for decades, working to improve access to contraception and make it easier for low-income and marginalized people to get needed medications. Dozens of major medical organizations, such as the American College of Obstetricians and Gynecologists and the American Medical Association, voiced support for over-the-counter contraception without age restrictions.

People will be able to purchase Opill in a variety of sizes, including a one-month supply, three-month supply and six-month supply. In July, the U.S. Food and Drug Administration approved Opill for over-the-counter use, determining that people could safely and effectively decide on their own — without consulting a doctor — whether Opill is appropriate for them. With that decision, the United States joined the more than 100 countries that already allow over-the-counter use of birth control pills, according to Free the Pill.

While over-the-counter access is new in the U.S., the progestin-only pill is not; Opill has been used for 50 years on a prescription basis. The pill works by thickening the cervical mucus, which helps block sperm from reaching an egg.

Filling gaps

There are over a dozen methods of short- and long-acting contraception that range in ease of access, cost, permanence and efficacy, and Swartz said he’s glad an over-the-counter pill is being added to the mix.

Swartz said he expects Opill will help reach more people in need of contraception. That’s important because access to contraception is key to preventing unwanted pregnancies.

In North Carolina, 637,960 women with low income live in areas that can be classified as “contraceptive deserts,” according to data from the nationwide pregnancy prevention advocacy group Power to Decide. A contraceptive desert is a county or area that lacks reasonable access to a health center that offers the full range of contraceptive methods, such as a gynecologist’s office or a community health clinic.

Access to contraception varies across the state. Pharmacies are a new site of access for hormonal contraception that could help combat contraceptive deserts. In particular, Swartz said people living in rural areas where there are often provider shortages and less access to health care may benefit the most from this over-the-counter option.

More than one in three women using oral contraceptives reported that they had missed taking doses because they were unable to get their next supply, according to a 2022 KFF Women’s Health Survey.

Swartz explained if someone can’t see a doctor to get a refill on their current contraception prescription before it runs out, they could use Opill to bridge the gap. But Opill should not be used at the same time as any other hormonal birth control product, including other oral pills, patches or injections, vaginal rings or intrauterine devices.

“It's a real shame to lose access to contraception completely in that gap,” Swartz said. “This means that you can go to a pharmacy and even if you couldn't get the contraception that you were on, you'd have something to protect you in the meantime.”

While Swartz said Opill can help fill important gaps, the pill won’t be the right fit for everyone.

For example, because Opill requires people to take daily pills within the same three-hour window every day to be effective, a person needs to be reliable.

“If you know you're someone who's not going to take a pill every day or couldn't remember to take a pill at the same time because your schedule changes a lot, then this probably isn't the best option for you,” Swartz said.

The FDA said Opill should not be taken by anyone with a history of breast cancer, and people who have had any other form of cancer should ask a doctor before use.

Outside the doctor’s office

Since almost 90 percent of the U.S. population lives within five miles of a community pharmacy, access to contraception at these sites could improve access overall. Research shows people may opt to get contraception at pharmacies because they are nearby, have extended hours and don’t require appointments.

Beyond finding Opill at pharmacies, an increasing number of pharmacists in North Carolina are stepping up to prescribe hormonal contraceptives after passage of a 2021 law.

Jennifer Burch, a pharmacist who owns Central Pharmacy in Durham, speaks about implementing pharmacist-prescribed contraception. ”Pharmacists are hungry to do other things besides dispense medications to patients,” she said. “Now is the time for pharmacists to step up and step in to provide clinical services in an area that is much needed in the state of North Carolina.” While pharmacist-prescribed contraception is not yet widespread, Mollie Scott, UNC Eshelman School of Pharmacy regional associate dean who is helping lead implementation across the state, said about 80 counties now have at least one birth control pharmacist providing the service. She’s working to ensure that number continues to grow.

“I can see a woman coming into the pharmacy and maybe she can't find [Opill] or she's asking if it's available and then the pharmacist — if they’re a birth control pharmacist they can have the conversation with her about, ‘Yes, there's that that’s over the counter. We also have other options we could do for you here in the pharmacy,’” Scott said. “Then even having a more comprehensive conversation in case what she's really looking for or [if] what she needs is something that only a physician provider could give.”

Still need to improve access

While Singiser from Contraception Access Initiative applauds Opill as a significant step toward improving contraception access, she said further action needs to be taken to ensure it's “affordable for all.”

In July, the U.S. Food and Drug Administration approved Opill for over-the-counter use, determining that people could safely and effectively decide on their own — without consulting a doctor — whether Opill is appropriate for them. With that decision, the United States joined the more than 100 countries that already allow over-the-counter use of birth control pills. The $20 price for a one-month supply will be out of reach for some folks, she said. KFF’s 2022 Women’s Health Survey found that 11 percent of women would not be willing or able to pay anything for an over-the-counter oral contraceptive, and 39 percent would pay $1-$10 per month. Only 16 percent said they would pay more than $20 a month.

Perrigo, the manufacturer of Opill, announced it will offer a cost-assistance program in the coming weeks to help qualified-low income, uninsured individuals obtain Opill at low or no cost.

While federal policy requires most private health insurance plans and Medicaid expansion programs to cover the full range of FDA-approved contraception with a prescription, there is no requirement that plans cover the cost of nonprescription contraceptives.

Singiser and others want that to change.

“It makes absolutely no sense to cover a medication like Opill when you get it with a prescription but not cover it when you get it without a prescription, so Contraception Access Initiative is working hard to make that possible and address that barrier,” Singiser said.

Ultimately, she said the best way to do that is with a uniform federal policy that requires all insurance plans to cover over-the-counter contraception. Polling shows that the majority of Americans support access to contraception, and legislative bills to require this are in the works.

“Part of the work, of course, is not just getting them on those store shelves in every community, but making sure that they are affordable to anyone who needs it,” Singiser said.


This article first appeared on North Carolina Health News and is republished here under a Creative Commons license.

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