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As much as we try to dutifully interrupt sexual bliss to rummage around in the bedside table for a box of condoms, set alarms on our phones to remind us to take the pill each day, or make sure we get that IUD fitted – how many of us actually think unintended pregnancy will happen to us? How many of us give serious thought to the chances of that faint pink line appearing on a test?

But it happens.

“As of 2011, 45% of pregnancies in the US were unintended,” says Komkwuan (Kwuan) Paruchabutr, Assistant Professor at Georgetown University School of Nursing and President of the National Association of Nurse Practitioners in Women’s Health. “That number is even higher for patients from marginalized communities.”

Let that sink in for a moment.

“Around 42% of pregnancies end in abortion,” Paruchabutr continues. “The data is clear and the medical community is in agreement: Contraception is essential healthcare.

These are all points that Paruchabutr made when giving oral testimony to the US Food and Drug Administration (FDA) in support of a landmark moment for the health and bodily autonomy for women and Assigned Female at Birth (AFAB) folks: The launch of America’s first ever over-the-counter (OTC) oral contraceptive, Opill.

This is a seriously big deal, as anyone who’s lost out on contraception due to factors like convenience (e.g. trying to get an appointment with a healthcare provider) will know. As the first of its kind in the United States – approved by the FDA in 2023 and, as of early March this year, rolled out in retailers like Walgreens and Target – Opill is something of a history-maker.

I asked Paruchabutr why she believed strongly enough in Opill to testify in front of the FDA. “Hormonal contraception is one of the most widely used and extensively studied medications on the market,” she replied. “Over sixty years of research and data show that it is safe and effective at preventing unintended pregnancy. I believe in access to all hormonal contraception for those who qualify and Opill falls under that criteria.

Safe to say, the launch of Opill is worthy of focused attention; as well as deserving of a glass of champagne (or three). So let’s take a deep dive into Opill: How it works, why it deserves to be celebrated and whether there are any drawbacks; together with important advice for anyone considering any contraceptives.

💊 Progestin-only.  The key thing you need to know about how Opill actually works is that it’s progestin-only. It contains a hormone called norgestrel, which thickens cervical mucus – and this thickened mucus makes it harder for sperm to reach the egg. It affects ovulation, too, thus preventing the ovaries from releasing an egg each month; and it changes the uterine lining to prevent a fertilized egg from implanting.

💊 Over-the-counter.  As someone based in the UK, the idea of oral contraception being available without a prescription is mind-blowing; but that’s exactly what Opill is. Users can buy the pill at a major retailer or online without having to make an appointment with a doctor first.

💊 Daily pill.  Opill is designed to be taken once a day; crucially, at the same time every day. “Missing a dose or taking it more than a few hours late can reduce [its] effectiveness in preventing pregnancy,” warns Be Well Family Care’s Micaela Simon, HIV specialist and FNP-C, AAHIVS.

💊 Contraception. Opill starts working within 48 hours of taking the first pill; until that point, a barrier method (like a condom) will need to be used. This goes for late or missed pills, too. It’s also important to note that Opill is not intended to be used as emergency contraception. Plus, the clue’s in the name; Opill is contraception. It does not protect against the transmission of STIs; barrier methods will still need to be used for that.

💊 Effectiveness.  Opill is advertised as being 98% effective at preventing pregnancy with ‘perfect use’; which means taking the pill every single day at exactly the same time each day. We’re all human, though, and even the most important things can slip our minds if our routine is thrown out. So it’s worth factoring in the efficacy rate for ‘typical use’, too, which is 91%: Meaning that if 100 people take Opill, but not perfectly, around nine of them could get pregnant in a year.

A Woman Holding a Pill

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🌞 General access. Another of Paruchabutr’s points when testifying to the FDA was: “Over-the-counter access reduces some of the most common barriers to hormonal contraception – lack of access, inconveniences of obtaining a prescription, and high cost,” she said.“Over-the-counter availability may empower individuals to take greater control of their reproductive health decisions, allowing them to make choices independently and confidentially,” agrees Simon. On which note…

🌞 Adolescent access. Safe adolescent access to contraception is paramount, and Opill offers the opportunity for this. It removes the need for an adolescent to discuss contraception with a medical provider; one barrier gone. It increases privacy – especially important for those who feel uncomfortable or unsafe discussing their reproductive health with others – another barrier gone. The online availability of Opill aligns with a younger demographic; and the absence of a prescription increases teenage women and AFAB folks’ sense of bodily autonomy.

🌞 Starting the conversation: Simon has some advice for under-18-year-olds seeking contraception, though. “It’s important to seek guidance from a trusted adult, such as a parent, guardian, or healthcare provider or pharmacist,” she says; and encourages under-18s to explore their birth control options. “There are various contraceptive methods available, including condoms, birth control pills, intrauterine devices (IUDs) and contraceptive implants, among others. Take time to explore these options and consider factors such as effectiveness, ease of use, side effects, and personal preferences.” Finally, Simon encourages under-18s to learn about STIs and how to prevent them. “Condoms not only can provide contraception, but also offer protection against STIs, if you are sexually active it is essential to prioritize both pregnancy prevention and STI prevention.

🌞 Progestin-only.  Yep, we have already spoken about this; but what we didn’t mention is that, as a progestin-only birth control pill, Opill is ideal for those who can’t use combined birth control methods (those containing estrogen). “As a non-estrogen containing oral contraceptive, it is safe for many, with minimal side effects,” agrees Simon. “This is a great option for people who cannot take estrogen.

Almost everything has some drawbacks; and Opill is no exception.

  1. Equitable health access. Opill’s manufacturer, Perrigo, has priced it at $19.99 per pack. The Free The Pill coalition has flagged this as being too expensive for many women; particularly those impacted by systemic inequities.The coalition report found that a monthly cost of $20 per pack left many in a position of having to choose between birth control or other necessities. The report highlighted research and polling showing that $10 or less per month was instead considered a realistic price point.
  2. Menstrual irregularities.  “Some individuals may experience changes in their menstrual cycle, such as irregular bleeding or spotting between periods,” Simon explains. “While these changes are not usually harmful, they can be bothersome for some users.” And, while not necessarily a drawback, there are considerations to bear in mind. “While [OTC] oral contraceptives can improve access for many individuals, they may not be suitable for everyone,” says Simon – and Opill is no different. It’s not suitable for everyone; those with a history of breast cancer or some rare types of liver disease, for example. “It’s important to recognise that comprehensive reproductive healthcare services, including screening for [STIs] and access to a range of contraceptive methods remain essential components of reproductive healthcare.

Regardless of these considerations, Opill marks a significant step forward in reproductive healthcare and bodily autonomy; and the effects are likely to be felt for years to come.

For starters, some practicalities. “The availability of Opill could lead to shifts in contraceptive use patterns, with more individuals opting for oral contraceptives over other methods,” posits Simon. “This could have implications for healthcare providers, who may need to adapt their counseling and services to meet the changing needs and preferences of their patients.

Plus: “The introduction of Opill or a similar over-the-counter oral contraception will likely raise regulatory considerations related to safety, efficacy, labeling, and post-marketing surveillance,” Simon continues. “Regulatory agencies such as the FDA will play a crucial role in ensuring that such products meet established standards and continue to monitor their safety and effectiveness over time.

Keeping [the] cost down for 3 month, 6 month, 12 month supply is important as well and ensuring that there is cost assistance for all will be critical,” Paruchabutr adds.

There may well be practical considerations, and they’re important to bear in mind and to monitor; particularly with regards to safety. But the launch of Opill is an occasion to celebrate: “OTC access for Opill is monumental for the SRH landscape,” says Paruchabutr, and we agree.

It’s all about access to healthcare,” Simon concludes. “Making contraception more readily available will give people the opportunity to avoid unintended pregnancies. I think this is long overdue”; and, again, we agree.

For more information, visit Opill’s website; and remember to discuss the use of any contraceptive with a healthcare provider, if you feel able, to determine what the right option may be for you personally. And if you’re still looking for more information on anything to do with birth control options, you can visit Hormonally’s ‘Birth Control’ resources page; a veritable mine of information on all things birth control.

This blog post was authored in collaboration with Daye. For other great reads on important women’s health topics, head over to Daye’s blog, Vitals.