Clinical Overview: Opill as First OTC Contraception in United States

In July 2023, the FDA approved norgestrel (Opill) tablets to be available without a prescription for pregnancy prevention. This marks a significant milestone as norgestrel becomes the first daily oral contraceptive approved for nonprescription use in the United States.¹

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This approval means that patients now have the option to purchase this progestin-only oral contraceptive pill without needing a prescription. Norgestrel will be accessible at various retail locations, including drug stores, convenience stores, grocery stores, and online platforms. OTC oral contraception has garnered endorsements from prominent medical organizations, including the American College of Obstetricians and Gynecologists, the American Medical Association, the Society for Adolescent Health and Medicine, and the American Academy of Family Physicians.²

The nonprescription availability of norgestrel can potentially diminish obstacles to access because it enables individuals to acquire an oral contraceptive without requiring an initial health care provider visit. In the United States, nearly half of the 6.1 million pregnancies each year are unintended, and these unplanned pregnancies have been associated with adverse maternal and perinatal consequences.¹

These consequences include a lower likelihood of receiving timely prenatal care and an increased risk of preterm delivery, which is linked to adverse neonatal, developmental, and child health outcomes. Making norgestrel available without a prescription may contribute to reducing the incidence of unintended pregnancies and mitigating their potential adverse effects.

However, granting OTC approval for the progestin-only pill, often referred to as the "minipill," also gives rise to concerns regarding cost, accessibility, and the potential unintended consequence of limiting opportunities for comprehensive sex education and reproductive health care. Anticipated availability of the pill on store shelves is scheduled for early 2024.⁴

There will no age restrictions for purchasing norgestrel. This change could have a significant effect on adolescents and young adults, particularly those who may not have had previous access to birth control due to resource limitations.

Norgestrel is a hormone that falls under the category of progestins. As a progestin, it exerts its effects through binding to progesterone receptors and modulating various physiological processes.

Norgestrel suppresses ovulation, the release of an egg from the ovary, by inhibiting the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland. This prevents the maturation and release of eggs from the ovaries, reducing the chances of fertilization.

It thickens the cervical mucus, making it more viscous and less permeable to sperm. This alteration hinders sperm from successfully passing through the cervix and reaching the uterus and fallopian tubes, where fertilization typically occurs.

Norgestrel affects the uterine lining (endometrium), making it less receptive to the implantation of a fertilized egg. This alteration reduces the likelihood of a fertilized egg attaching to the uterine wall and developing into a pregnancy. Progestins like norgestrel can affect the fallopian tubes' ability to transport the egg and sperm, further reducing the likelihood of fertilization. It's important to note that Opill does not contain estrogen.⁴

To ensure its effectiveness, this medication must be taken consistently every day at the same time. Failure to do so may reduce its effectiveness, potentially leading to pregnancy.

When used perfectly, norgestrel tablets are highly successful in preventing pregnancy. In initial clinical trials, the perfect-use effectiveness rate can reach as high as 98%. This means that only 2 out of every 100 women using it for a year may become pregnant.⁴

Perfect use entails taking one tablet daily, consistently at the same time each day, without any interruptions between monthly packs. Additionally, perfect use requires using backup birth control, such as condoms, if a person misses or experiences a delay of more than 3 hours in taking the daily tablet.⁴ This added precaution further enhances its effectiveness in preventing pregnancy.

Many states in the USA have already granted pharmacists the authority to prescribe hormonal contraceptives, including birth control pills, patches, and hormonal rings. This authority varies by state, so the specific regulations and scope of practice for pharmacists can differ significantly from one state to another.

The age at which individuals can obtain pharmacist-prescribed contraceptives without a doctor's prescription also varies by state. Some states have set a minimum age requirement, while others allow any eligible individual to access these services.

When prescribing contraceptives, pharmacists often conduct patient assessments, including reviewing the patient's medical history and any contraindications. They may ask about smoking habits, blood pressure, and other relevant factors to ensure the chosen contraceptive is safe and appropriate for the individual.

Pharmacists play a crucial role in educating patients about their contraceptive options including OTC birth control as well as emergency birth control. Pharmacists educating patients about proper usage, potential side effects, and the importance of consistent and correct use.

In cases where a patient's health history or specific needs require consultation with a health care provider, pharmacists can refer patients to appropriate medical professionals. Pharmacists often collaborate with primary care providers to ensure continuity of care, sharing relevant patient information and notifying providers when prescriptions are issued.

References

1. U.S. Food and Drug Administration. FDA Approves First Nonprescription Daily Oral Contraceptive. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive. Accessed on September 2, 2023.
2. Perrigo Announces U.S. FDA Approval for Opill OTC Daily Oral Contraceptive. https://www.prnewswire.com/news-releases/perrigo-announces-us-fda-approval-for-opill-otc-daily-oral-contraceptive-301876638.html. Accessed on September 2, 2023.
3. CNN Health. FDA approves first over-the-counter birth control pill. https://www.cnn.com/2023/07/13/health/fda-otc-birth-control-opill/index.html. Accessed on September 2, 2023.
4. U.S. Food and Drug Administration. Opill (0.075mg Oral Norgestrel Tablet) Information. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information. Accessed on September 2, 2023.