Experiences using an over-the-counter progestin-only pill in a trial in the United States

By Kate Grindlay

Read the research papers here and here.

In 2021, two progestin-only oral contraceptive pills (POPs) were approved in the UK as “pharmacy medicines,” becoming available without a prescription. Efforts are also currently underway to make a POP over the counter (OTC) in the United States, with an application under review at the US Food and Drug Administration (FDA) and the FDA Advisory Board Committee meeting scheduled to take place in May 2023 to provide advice and recommendations to the FDA on the switch application. These advances follow more than 100 countries worldwide that already have non-prescription access to oral contraceptives.

A body of research documents the experiences of women living in the United States who travel across the US-Mexico border to get oral contraception without a prescription in Mexico. This research shows that those who got oral contraceptives OTC had higher rates of continuation compared to those getting them from clinics, while still obtaining preventive screenings at levels higher than the national average. Less than 1% of oral contraceptive users had a contraindication to POPs, with no significant differences in the prevalence of contraindications to POPs between OTC and clinic users.

Non-prescription access to oral contraceptives has the potential to reduce access barriers to an effective and popular contraceptive method. Prior research from the United States found nearly one-third of women at risk of unintended pregnancy have faced barriers getting prescription contraception, and 39% of adult women at risk of unintended pregnancy and 29% of teens were interested in hypothetical OTC POP use. However, no prior research has explored user experiences with an OTC POP. While bleeding has been documented as a common side effect of taking progestin-only contraceptive methods generally, little is known about people’s experiences using POPs or how those experiences might impact OTC POP uptake and continuation.

To understand user experiences, we conducted an online survey with 550 adults and 115 teens who had used an OTC POP (norgestrel 0.075 mg tablets) for up to six months in a US trial. We assessed both acceptability of OTC POP use and likelihood of future preventive health screenings while using an OTC POP, among other topics. In this first study exploring people’s experiences with OTC POPs, we found high satisfaction with the method among both adults and teens. Most reported they would continue to use an OTC POP if it were available in the future (83%) and found the menstrual bleeding they experienced during POP use acceptable (80%). Among participants who had used contraception in the month prior to the trial, more than three-quarters said their overall OTC POP experience was similar or better. Top benefits of the OTC POP compared to prior methods included less worry about pregnancy, ease of access, fewer side effects, and greater decision-making power.

The study’s findings also demonstrated potential equity impacts associated with non-prescription POP access, with Hispanic/Latinx and Black participants and adults with public insurance reporting higher likelihood of future use compared to their counterparts. Participants who experienced challenges accessing prescription contraception were also more likely to report interest in using an OTC POP compared to those who did not face challenges. Also of note, 72% of participants were not using any contraceptive method or were using a less effective method in the month prior to the trial. The use of an OTC POP in a trial setting among these individuals highlights the potential public health relevance and benefit that OTC access may have in increasing contraceptive access for individuals who currently face barriers.

Among those in our study who were not interested in using an over-the-counter progestin-only pill in the future, the most common reason was not liking the bleeding they had experienced. Like all progestin-only methods, POPs cause bleeding changes in a significant proportion of users, and the most common complaint among POP users in general is irregular bleeding. At the same time, some participants in our study considered the bleeding changes they experienced a benefit of the method, highlighting people’s differing contraceptive preferences and experiences. These data indicate the need for clear labeling and consumer education to inform potential users about possible bleeding changes associated with POP use.

Among participants who said they were interested in continuing to use an OTC POP, the vast majority (90%) wanted to use it long term, and 79% aged ≥25 years reported they would get future preventive gynecologic screenings when using an OTC POP, which was similar to the 75% aged ≥25 years who reported they had had a cervical cancer screening in the prior 3 years. The primary reasons participants cited for interest in using an OTC POP included convenience (81%), ease of access (80%), and saving time (77%) and money (64%) from not having to visit a clinic.

These findings highlight the real-world acceptability of taking a POP without a prescription, and add to prior data on hypothetical interest in use, including on the tolerability of bleeding changes users may experience. This research shows that coupled with affordable pricing and public awareness, OTC access to POPs has the potential to address access barriers and to put effective contraception within reach for a large population of users.

About the author

Kate Grindlay, MSPH, is a social science research consultant with Ibis Reproductive Health with a focus on exploring the potential of innovative approaches and technologies to increase health access.

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