What Pediatricians Need to Know About Over-the-Counter Oral Contraception

The first over-the-counter contraceptive pill – the Opill® – is currently available in retail outlets and online.

The FDA approved the sale of Opill® (nongestural 0.075mg), the first over-the-counter birth control pill without age restrictions, in July 2023. Now, nearly a year later, it will be available soon in retail outlets and online.

As a progestin-only oral contraceptive pill, Opill’s only absolute contraindication is current breast cancer.  It should only be used by females and should not be used by pregnant people.

Who might be the “ideal candidate” for over-the-counter birth control pills, and how can I best to counsel patients regarding this option vs prescription options?

People who face barriers to traditional medical care, such as adolescents and young adults, are good candidates for use of over-the-counter birth control. Not being able to get to an office appointment and not being able to get prescription refills at pharmacies are barriers to contraception use. With access to contraception expanded with this option, many people may be better able to avoid unwanted or mistimed pregnancies.

Some patients may present to the pediatric office reporting use of the Opill, and it may be the best option for them. However, it is possible that other prescription contraceptive methods would benefit the patient. We recommend having patient-centered conversations and using shared-decision making to confirm which option best suits their needs.

Many adolescents considering birth control worry about side effects such as excessive weight gain or irregular bleeding. Are side effects of Opill similar to other progestin-only contraceptive pills?

The active hormone in Opill is norgestrel. Other progestin-only oral contraceptives are available by prescription and contain norethindrone or drospirenone. Opill shares many properties of other progestin-only contraceptive pills. The main side effect of Opill is changes in menstrual bleeding pattern. The pattern is hard to predict – some patients may still have a “period,” some patients may spot or bleed irregularly, and some may not bleed at all. This is similar to other progestin-only pills.

Progestin-only contraceptive pills do not cause weight gain.

Patients should be counseled about bleeding changes associated with contraceptive use. Side effects are especially important to adolescent patients. Also, it’s important that they know they can contact their pediatric provider’s office with concerns.

What should patients and parents know about how effective the Opill is in preventing pregnancy?

Effectiveness is similar to that of other contraceptive pills. Studies on Opill found that with typical use it is 93% effective in preventing pregnancy.

How can we counsel patients who miss one or more pills?

Guidance for what to do for missed pills is the same as other progestin-only pills. According to the Centers for Disease Control (CDC), a dose is considered missed if it has been >3 hours since it should have been taken. The patient should take one pill as soon as possible, and continue taking pills daily, one each day, at the same time each day, even if it means taking two pills on the same day.

The over-the-counter availability of Opill® addresses many barriers to obtaining contraception. However, cost can still be a barrier. Would Medicaid or any assistance programs cover this option?

The suggested retail price is $19.99 per month or $49.99 for a three-month pack. This is still unaffordable for many people. There is currently no federal requirement that insurance plans cover non-prescription contraception. How insurance plans cover Opill is likely something that we will see changes in – but currently no laws in Ohio require plans to cover over-the-counter contraceptive pills. An option for uninsured and low-income people is to use the manufacturer’s patient-assistance program.

Dr. Berlan, an Adolescent Medicine Pediatrician, founded the BC4Teens Program at Nationwide Children’s, was on the FDA advisory panel for Opill, and co-authored the ACOG Practice Advisory on OPill®.

Dr. Weingart is a Primary Care Pediatrician, is Associate Chief of Clinical Operations for Primary Care Pediatrics and leads contraception-access related QI efforts within primary care pediatrics.