The Society of Family Planning and the North American Society for Pediatric and Adolescent Gynecology endorse this Practice Advisory.
This Practice Advisory was developed by the American College of Obstetricians and Gynecologists.
Background
On March 4, 2024, the first daily over-the-counter oral contraceptive pill became available in the United States. The distribution process and its availability in stores and online will be an ongoing process, so availability initially may be limited. The U.S. Food and Drug Administration (FDA) approved Opill, a progestin-only (0.075-mg norgestrel) tablet, on July 13, 2023. This progestin-only pill (POP) is approved without a prescription for adolescents and adults to prevent pregnancy. The FDA did not approve this POP for menstrual suppression or other noncontraceptive indications. The FDA requires data to demonstrate that a medication can be safely switched to an over-the-counter product. Studies demonstrated that this medication can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional 1 .
The Safety of Progestin-Only Pills
The American College of Obstetricians and Gynecologists (ACOG) has long supported over-the-counter access to oral contraception 2 . Both POPs and combination estrogen and progestin pills are associated with a lower risk of complications than those seen during pregnancy and the postpartum period. There are some conditions that are absolute or relative contraindications to POP use, including current or past breast cancer. See the Centers for Disease Control and Prevention’s U.S. Medical Eligibility Criteria for Contraceptive Use for more information 3 . Individuals with obesity can safely use POPs, so screening for obesity is not needed 4 . No examinations or tests, including pelvic examinations and cervical cancer screening, are needed prior to the initiation of POPs 4 , and the need for routine preventive health visits should not be used as a barrier to over-the-counter access to contraception. Additionally, data demonstrate that potential users of over-the-counter hormonal contraceptive pills are effectively able to self-screen for potential contraindications 2 .
Clinical Considerations
Current data support that the efficacy of POPs is similar to that of combined progestin–estrogen contraceptive pills. For both types of oral contraceptives, 9% of U.S. women during the first year of use will have an unintended pregnancy with typical use, and 0.3% with perfect use 5 . It is important that POPs are taken at the same time each day (within the same 3-hour window). Those who miss pills (see Box 1), experience adverse effects with POPs (such as irregular bleeding), or who prefer another method of contraception should talk to a clinician about potential alternative methods.
Box 1. Missed Pills
If you are more than 3 hours late taking your tablet or miss taking your tablet on 1 or more days:
- Take 1 tablet immediately, as soon as you remember that you missed it.
- Then go back to taking your daily tablet at your usual time.
- Use a condom (or another barrier method) every time you have sex during the next 2 days (48 hours), because it takes 2 days for this product to start working again.
Data from U.S. Food and Drug Administration. Opill norgestrel tablets 0.075 mg daily oral contraceptive. Accessed February 23, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017031s041lbl.pdf
Progestin-only contraceptives are safe for use during the postpartum period and for those breastfeeding 3 . For those concerned about confidentiality or who may be a victim of contraceptive coercion ( 6 , 7 ), an over-the-counter purchase allows the user to bypass insurance and avoid potential disclosure from itemized explanation of benefits statements. The over-the-counter POP may be a good option for those in between contraceptive methods or who do not have immediate access to a clinician or prescription refills. When patients using an over-the-counter method present for care, clinicians may provide counseling on other effective contraceptive methods but should support patient desires to continue with an over-the-counter method, if it is preferred. For more information on POPs and other contraceptive methods, see ACOG’s patient education resources at https://www.acog.org/womens-health/healthy-living/birth-control.
As with all nonbarrier contraceptive methods, the over-the-counter POP does not protect against sexually transmitted infections. Clinicians should advise those who choose the over-the-counter POP to use male or female condoms consistently (dual method use) to decrease the risk of sexually transmitted infections, including human immunodeficiency virus.
Access and Cost
Cost is a common barrier to accessing contraception. While having a user-dependent hormonal method available over the counter is a key step toward increasing access to family planning, if consumers cannot afford to purchase it (in person or online), including buying multiple packs at once, then the method is not truly accessible. Historically, high out-of-pocket costs, deductibles, and copayments for contraception have limited contraceptive access, even for those with private health insurance. A switch to over-the-counter access should not add yet another barrier for someone who desires contraception. While insurers are not required to cover over-the-counter contraceptives without an accompanying prescription, several states have passed laws requiring state-regulated private health plans to cover certain over-the-counter methods (eg, emergency contraception and condoms) without a prescription and without cost-sharing 8 . To address disparities in reproductive health, policies for over-the-counter contraception should cover Opill without a prescription requirement and at no up-front cost to the user, regardless of payer.
Conclusion
For both adults and adolescents, over-the-counter access to oral contraceptives has the potential to reduce barriers and increase contraceptive access 9 . The American College of Obstetricians and Gynecologists affirms the safety of the progestin-only oral contraceptive pill and the appropriateness of its over-the-counter availability. Over-the-counter methods should be both accessible and affordable.
Resources
These materials are for information purposes only and are not meant to be comprehensive. Referral to external resources does not imply ACOG’s endorsement of the organization, the organization’s website, or the content of the resource. The resources may change without notice.
- ACOG Committee Opinion No. 788, Over-the-counter Access to Hormonal Contraception
- ACOG Patient Education: Birth Control
- U.S. Food and Drug Administration. Opill norgestrel tablets 0.075 mg daily oral contraceptive. Accessed February 23, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017031s041lbl.pdf
- U.S. Food and Drug Administration. Opill (0.075mg oral norgestrel tablet) information. FDA; 2024. Accessed February 23, 2024. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information
- Perrigo. Opill. Accessed February 23, 2024. https://opillhcp.com/
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