Q&A: Survey supports OTC progestin-only pill availability to increase contraceptive access
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Over-the-counter progestin-only pills may provide the benefits of other contraceptives while eliminating substantial barriers to access, according to a survey of participants in a study of OTC progestin-only pills.
Kate Grindlay, MSPH, a research consultant at Ibis Reproductive Health in Cambridge, Massachusetts, and colleagues surveyed 550 adults and 115 adolescents (aged 11-17 years) who participated in the Adherence with Continuous-Dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS) study. The ACCESS study simulated an OTC setting for up to 6 months to determine participants’ selection of and adherence to norgestrel tablets.
Survey results showed that 55% of participants reported their experience with menstrual bleeding during the study as “acceptable” and that 25% of participants “did not have positive or negative feelings” about their menstrual bleeding during the study.
Healio spoke with Grindlay to learn more about the need for OTC progestin-only pills.
Healio: What prompted your research on this topic?
Grindlay: For nearly 2 decades, a body of research has shown that OTC access to oral contraceptives would be safe and effective, and that removing the prescription requirement would make it easier to obtain and consistently use birth control pills. For these reasons, leading medical organizations support it, including the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians and the American Medical Association.
Now, for the first time, an OTC birth control pill could soon be on the shelves. An application is under review at the U.S. Food and Drug Administration to make a progestin-only pill available OTC in the United States. If approved, this would be a groundbreaking advance for contraceptive access in the U.S., with the potential to reach millions of users. In prior research, 39% of adults and 29% of teens reported being interested in hypothetical OTC progestin-only pill use, citing the time and money it would save, as well as being able to quickly and easily start the pill when they needed to. However, little is known about people’s experiences using progestin-only pills. We wanted to understand those user experiences and how they might provide insight into future OTC progestin-only pill uptake and continuation.
Healio: What is the take-home message for clinicians?
Grindlay: In our study of individuals who used OTC progestin-only pills in a U.S. trial, we found that the vast majority had positive experiences, with 83% reporting they would use an OTC progestin-only pill in the future if it were available and 77% who had used a contraceptive method in the month before the trial reporting their experience was similar or better than the previous method. These findings highlight the acceptability of and desire for OTC progestin-only pills and indicate that if the progestin-only pill becomes available OTC in the U.S., users will similarly have positive experiences. This study adds to the strong body of research demonstrating the safety, effectiveness and acceptability of OTC progestin-only pills.
Healio: What need is there for OTC hormonal contraception?
Grindlay: Up to one-third of those who try to get hormonal methods face access barriers, ranging from the cost of a clinic visit to be being uninsured; having to take time away from work, school or taking care of children; transportation challenges; and confidentiality issues. OTC availability would increase access to a safe and effective method of contraception.
Healio: What is the history of approvals for OTC hormonal contraception, and what is the likelihood that the FDA will approve this one?
Grindlay: Progestin-only levonorgestrel emergency contraception was approved for OTC sale for people of all ages in 2013, after a protracted, multiyear approval process centered on adolescent access. Since then, research has shown notable increases in emergency contraception use among teens and young adults following the OTC switch, and that OTC access improves timely use of the method.
The current application under review at the FDA for a daily use OTC progestin-only pill, as another progestin-only method, is a logical next step, and the data are strong in support of an OTC progestin-only pill for people of all ages. Progestin-only pills are simple to take and safe for nearly all people seeking contraception.
Healio: What does the OTC hormonal contraceptive landscape look like in other countries?
Grindlay: We conducted a review of oral contraception prescription policies worldwide and found that they are available without a prescription in more than 100 countries. Most recently, the United Kingdom approved nonprescription access for two brands of progestin-only pills.
Healio: Would progestin-only pills have the ability to eliminate periods?
Grindlay: Yes, for some users, progestin-only pills have the advantage of improving menstrual symptoms, such as eliminating or reducing periods and menstrual cramping. For others, progestin-only pills can cause bleeding changes that are less desirable, such as irregular periods or spotting. In our study, we found that 80% of OTC progestin-only pill users felt their menstrual bleeding was acceptable [or reported they “did not have positive or negative feelings”].
Healio: Is there anything else you would like to add?
Grindlay: I am hopeful that with the public health need for greater contraceptive access and this strong supportive evidence base, the FDA will move quickly in its review of the OTC progestin-only pill application, and an OTC progestin-only pill may soon be a reality for the millions of interested users in the U.S.