Oct. 6, 2023 – The first over-the-counter birth control pill will hit U.S. stores early next year, which gives parents, teens, and their doctors time to decide how it will or could affect their lives. And the decisions are not always simple. The FDA approved the oral contraceptive, called Opill, this summer. It will be available without a prescription and is a progestin-only daily birth control pill, as opposed to a combination pill containing estrogen and progestin. According to the drug’s maker, Perrigo, Opill – sometimes called the minipill – will be available for purchase online and in stores in the first quarter of 2024, for people of all ages without a prescription. And more pills are expected to come down the road: Cadence , another pharmaceutical company, is working on FDA approval for its OTC combination pill called Zena. An OTC pill opens up a pathway for many to access contraceptive care when they couldn’t before. Getting an appointment, standing by for the day to come, taking time off work or school to make the visit – this process can sometimes take weeks, even months if your provider is slammed. An over-the-counter pill can be an option for those who are waiting on care from their OB/GYNs, while still needing protection against unwanted pregnancy. But, if anyone can grab an Opill pack at their local drugstore, does this change the way parents, children, and their doctors will approach the birth control topic altogether? For 16-year-old Maggie Cherkas, it might. She was raised by a single mother, Jill, outside Philadelphia, and their relationship is especially close. When she had her first serious boyfriend at 14, Jill “pitched” the idea of birth control to Maggie, who said she definitely did not need it at the time. Two years later, Maggie, who now has a new boyfriend, is more interested in learning about which birth control options she has. “I do really like the idea of something that’s over the counter,” Maggie said. “I feel like it would be kind of just be a whole process going to my doctor and having to get a prescription, always having to do that when I could just go to CVS and pick it up like any other cosmetic.” What gives Maggie pause is the questions she has for her doctor. She’d also like to know what questions her mom has – as Jill has been on the pill for years – that Maggie wouldn’t have even thought to ask. That’s why it’s highly unlikely that she’d go out and start Opill on her own, without first talking it through with her mom and doctor. Sarah Nosal, MD, a family medicine doctor based in New York City and director of the American Academy of Family Physicians’ board of directors, said that when Opill hits the shelves, she plans to talk about it, with both parents and kids, the way she would with any other OTC medication on the market. “Just like we talk about whether or not you should be taking acetaminophen or ibuprofen – if it’s right for you, if we need to be worried about side effects, how do you take it best to make it work for what we’re planning to use it for,” she said. “Those same conversations, but about the progestin-only pill.” Research shows that the progestin-only pill is safe to use and offers very few health risks. With “perfect use” – taking the pill at the same time each day – the efficacy rate is as high as 98%. Still, Nosal does understand the worries some parents might have going into these conversations. The minipill isn’t usually the first type of oral contraceptive that doctors prescribe for reproductive-age kids. Taking into consideration human errors and everyday forgetfulness, real-world use of both the combination and progestin-only pill is less effective at preventing pregnancy than with perfect use. But when it comes to the progestin-only pill, there is even less wiggle room. If you skip a pill or take one more than 3 hours late, you’ll need to use a backup birth control method for at least 2 days. “To be fair, for OB/GYNs, it’s not typically the first line of defense. First line really is that traditional combined birth control pill,” said Ryalynn fashion Carter, MD, an obstetrician-gynecologist at Columbia University Irving Medical Center in New York City. For Carter and most of her colleagues, the most common time to prescribe a progestin-only pill would be for postpartum patients, particularly those who are breastfeeding. How Much Will It Cost? We don’t yet know how much a single pack of OTC birth control pills will cost. In a statement , Perrigo emphasized its commitment to making Opill “accessible and affordable to women and people of all ages.” Whether or not insurance will extend coverage to Opill is also a major concern. Some forms of OTC contraception, like condoms, aren’t covered; but depending on your health insurance plan, you actually may be able to get Plan B (the morning-after pill) for free if you get a prescription from a health care provider. So far, six states have passed laws that require government-funded health insurance plans to cover OTC birth control without cost-sharing. But what insurance coverage of OTC contraception will look like in practice still poses many questions for patients, pharmacists, and insurers. A major concern for Carter and other providers like her is whether having an OTC birth control pill option will impact insurance companies’ willingness to cover other forms of contraception without first forcing a patient to try – and fail – with the OTC progestin-only pill. She recalls that when Prilosec, a brand of proton pump inhibitor used to treat acid reflux, became available over the counter, there were reports of insurance companies refusing to cover the more expensive, non-OTC options in the same drug class unless a consumer had already tried the OTC version. Carter worries the same could happen with contraception; maybe insurers will withhold coverage of intrauterine devices (IUDs) or the birth control patch until a patient tries Opill first. Even if both public and private insurance plans find a way to cover Opill and the other OTC oral contraceptives that are expected to follow its lead, there are still uninsured people and those under someone else’s insurance – like a partner or parent – who need the pill to be accessible, affordable, and confidential. The OTC progestin-only pill is an option for a teenager, or anyone under their parents’ plan, to access contraception without alerting insurance. It’s also an important option for those experiencing “contraceptive sabotage,” said Seattle-based pediatric and adolescent gynecologist Anne-Marie Amies Oelschlager, MD. “Maybe there’s a patient who is in an abusive relationship where a significant other was trying to coerce them into not using contraception, they could use this form of contraception without alerting their partner,” she said. “It’s more common than you would think.” And despite the closeness that Maggie has with her mom, Jill feels a sense of discomfort around the OTC pill having no age requirements. “I would not love it if my daughter could obtain it without my knowing,” said Jill. “We’re pretty open, but she wouldn’t mind avoiding an uncomfortable conversation if she could. … I do think you should be 18 or have parent permission.” While Carter doesn’t believe that the availability of Opill will change her patient volume, she does suspect that it will change the way visits might go with younger patients. “I do think that every now and again, when Mom steps out of the room, their daughters will look at me and say, ‘I’m actually on this pill that I got at Target,’” said Carter. “That’s my chance to catch them and say, that’s great, but it doesn’t prevent STDs and you have to know that.”
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