HealthMay 31, 2024

Over-the-counter (OTC) birth control pills: Improving access and reducing barriers

Clinicians play a major role in helping patients understand the safety, availability, and benefits of OTC birth control—and the impact to contraception access is significant.

Over-the-counter birth control pills represent a significant shift in the way that patients access contraception. For decades, prescription birth control pills have been the primary option for anyone seeking reliable contraception. However, the process of obtaining a prescription can be costly and time-consuming, especially for those without insurance or in areas with limited access to healthcare.

The first over-the counter birth control pill norgestrel went on sale in March online and in stores in April of 2024—an impactful development in the United States, where over half of the 6.1 million pregnancies each year are unintended. This development in healthcare access shifts the primary care clinician role from prescriber and repositions them as advisors in reproductive healthcare decisions. It also expands access deeper into the healthcare ecosystem, pulling in pharmacy professionals as additional sources of education and advice. Clinician input will become increasingly important as patients shift away from prescription birth control pills and begin to leverage retail pharmacies and drug stores as points of access to contraception. Providers will now work as partners with retailers that provide access to OTC birth control pills in supporting safe and effective use of the drug.

Providers will need to be familiar with the details around OTC birth control, including safety information, how access has helped many patients, and effectiveness.

Understanding the basics of OTC birth control pills

The first over-the-counter birth control pill is a progestin only pill, sometimes referred to as a “mini-pill”. This type of drug (norgestrel) was originally approved in 1973 as a prescription birth control pill. It is the first OTC birth control pill approved for use without a prescription.

The Food and Drug Administration (FDA) has stated that, “when used as directed, daily oral contraception is safe and is expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy.”

Safety measures for OTC birth control pills

OTC birth control was approved for nonprescription use by the Food and Drug Administration (FDA) in July of 2023. This means that an applicant demonstrates that a product can be used safely and effectively by consumers, without assistance from a healthcare professional and relying only on nonprescription drug labeling.

The pill should not be used in conjunction with other hormonal birth control products, including  intrauterine devices (IUDs), vaginal rings, oral contraceptive tablets, contraceptive patches, contraceptive implants, or contraceptive injections.

Availability and accessibility of OTC birth control pills

Norgestrel is currently available at major retailers, online, and at, and is sold in 3- and 6-month supplies.

Indications, contraindications, and side effects of OTC birth control pills

Opill, which is a brand name for norgestrel-only contraceptive pill packs, contains 28 tablets of 0.075 mg of norgestrel. These pills are taken once daily at the same time every day, with no pill-free interval between packs. Clinical studies involving over 21,000 28-day cycles have reported a pregnancy rate of 2 percent. Norgestrel-only pills work by suppressing ovulation, thickening cervical mucus, lowering mid-cycle peaks of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), slowing passage of the ovum through the fallopian tube, and altering the endometrium.

What providers should know about over-the-counter birth control pills

There are a few key points clinicians should keep in mind when discussing or recommending OTC birth control to their patients.

It reduces barriers to access

A study on access to prescription birth control revealed that about one-third of adult American women who have attempted to acquire prescription contraception have faced access barriers. Although the Affordable Care Act has addressed some of these issues, the study suggests that there may still be other factors that need to be tackled to improve access to contraception.

The key benefit of OTC birth control is the way it addresses healthcare access for patients who might have challenges. 11% of women in general report not having a personal doctor and the number is as high as 25% for Hispanic women. Additionally, one third of American women report facing access barriers when trying to obtain prescription access to contraception.

At a cost starting at $19.99 for a one-month pack, OTC birth control could be more affordable for many patients, especially considering they do not have to factor in the cost of a doctor’s visit or challenges in scheduling an appointment.

By eliminating the need for a prescription, OTC birth control pills can provide a reliable and convenient option for women who might not otherwise have access to contraception. This includes women who live in rural areas with limited access to healthcare, as well as those who may face barriers to accessing care due to cost or other factors.

In addition to the cost and time required to obtain a prescription, many women face other barriers to accessing care, such as transportation or time off work. This can make it difficult for them to obtain the contraception they need, which can lead to unintended pregnancies and other negative health outcomes.

Consumers can accurately assess their needs

According to a survey conducted in 2022 by KFF, a healthcare research organization, over 75% of women of reproductive age expressed their preference for an OTC pill. The primary reason for this preference was convenience.

Your patients are generally well-equipped to manage use of OTC birth control, including screening for contraindications. This has been proved in the past by a study of women between the ages of 19 and 49 using a medical checklist. Clinicians can support their patients in creating and using checklists customized to their goals in preventing unintended pregnancies. (Example of a self-screening checklist)

It’s effective

Norgestrel and drospirenone are effective when used correctly and while larger studies from real use situations are needed to confirm this, they approach the efficacy of the traditional estrogen-progestin combined contraceptives.

Norgestrel’s perfect use effectiveness rate is as high as 98% (according to the manufacturer), but use of hepatic enzyme-inducing drugs can reduce effectiveness.

It has broad support from the medical community

Dozens of medical organizations have supported the use of over-the-counter birth control without age restrictions, including:

  • American College of Obstetricians & Gynecologists
  • National Hispanic Medical Association
  • American Academy of Nursing
  • National Association of Pediatric Nurse Practitioners
  • American Academy of Pediatrics

Much of the world already has access

OTC contraception has been available outside the United States for years and is currently available in more than 100 countries, most commonly in Latin America, Africa, and Europe. Until now, the U.S. has lagged as one of the few countries that did not have at least one OTC birth control option.

The role of providers in navigating over-the-counter birth control pills

As healthcare professionals, we have the opportunity to help individuals achieve their reproductive goals and have healthy outcomes. Providing education about the benefits and risks of OTC birth control pills, as well as other contraceptive options, lets patients make informed decisions that meet their needs. This also includes providing guidance on how to use OTC birth control pills correctly and consistently.

Patients who have access to OTC birth control pills may be more likely to use contraception consistently and correctly than those who need a prescription. This can support improved patient control of if, and when, to become pregnant, which can improve health outcomes for the pregnant patient and baby.

Improving the quality of contraceptive services, which need to be rights-based and patient-centered, requires addressing knowledge gaps and biases among healthcare workers. The role of healthcare workers in providing family planning services, including counseling and prescribing contraception, is critical. However, personal biases can hinder a provider’s ability to support informed choice for their patients. It is crucial to understand the counseling and prescribing practices of health workers as well as their personal values and preferences towards contraception. By improving and standardizing education and training globally, we can ensure high-quality contraceptive services that are patient-centered, involve shared decision-making, and promote reproductive autonomy.

The future the provider role in OTC birth control

Clinicians will have growing opportunities to act as guides for their patients in answering reproductive healthcare questions and having culturally sensitive conversations about norgestrel as part of a complete plan for preventing unwanted pregnancies. These conversations can help improve medication adherence and patient understanding.

Effective conversations should be enabled by culturally sensitive technologies and content that aligns with the goals and demographics of your patient mix.

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