Over-the-Counter Oral Contraceptive Use and Initiation of Contraception

The US Food and Drug Administration approved the first over-the-counter (OTC) oral contraceptive pill (OCP) in 2023, potentially expanding access to contraception. Understanding whether OTC availability reaches individuals with systemic barriers to care is essential to assessing its public health impact.

To evaluate whether the newly available OTC progestin-only OCP is reaching individuals not previously using contraception or who rely on less-effective methods.

This cross-sectional study used baseline data from a national, prospective US cohort. Participants were individuals aged 15 to 45 years obtaining OCPs at pharmacies or online between April 2024 and February 2025. Participants were eligible if they obtained an OCP (prescription or OTC) for contraceptive use and were at risk of pregnancy.

Obtaining an OTC progestin-only OCP vs a prescription OCP.

Primary outcomes were (1) initiation of contraception among individuals previously not using any modern method and (2) transition from a less-effective method (eg, condoms or emergency contraception) to OCP use. Multivariable logistic regression models with robust SEs were used to determine adjusted absolute estimated probabilities and percentage point differences in outcomes.

The sample included 986 individuals, predominantly single (692 participants [70.2%]), and the largest proportion was aged 20 to 24 years (338 participants [34.3%]). OTC OCP users accounted for 320 (32.5%) of the participants. Individuals using the OTC option were more likely to be uninsured (101 participants [31.6%] vs 23 participants [3.5%]) and to reside in rural areas (46 participants [14.4%] vs 56 participants [8.4%]) compared with prescription users. Groups did not differ in fertility preferences. OTC use of contraception was associated with a 31.8 percentage point increase (95% CI, 24.1-39.5 percentage points) in moving from nonuse of contraception to the OTC pill, when compared with prescription OCP users. Similarly, OTC access was associated with a 41.0 percentage point increase (95% CI, 33.8-48.1 percentage points) in transitioning from use of a less-effective method of contraception to the OTC pill.

In this cross-sectional study of US individuals obtaining oral contraception, the OCP was accessed OTC by many who previously used no method or less-effective contraception. These findings suggest that OTC access may improve equitable access to contraception.