Commentary
Article
Knowing the benefits and effects of norgestrel can assist pharmacists when counseling patients.
Norgestrel (Opill; Perrigo), the first FDA-approved over-the-counter (OTC) birth control pill, was approved in July 2023 and became available for consumers on March 4, 2024.1 Norgestrel's active ingredient is norgestrel 0.075 mg tablets, a progestin-only pill (POP).
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The Affordable Care Act (ACA), enacted in 2010, increased health insurance coverage for uninsured individuals across the United States.2 The ACA particularly increased accessibility and affordability for women to receive annual appointments and free birth control. The 2015 Public Health Service Act, modified within the ACA, required contraceptive methods and preventative women’s services to be covered by most insurance companies without any out-of-pocket costs to the patient such as copayments or deductibles.3,4
The American Medical Association (AMA), American Academy of Family Physicians (AAFP), and American College of Obstetricians and Gynecologists (ACOG) support OTC oral contraceptives to improve accessibility.5,6 ACOG further supports “OTC access to hormonal contraception without age restrictions” and indicates that there is a need to provide OTC birth control based on barriers of accessibility and women’s interests.6
Based on 2024 CDC data, there are currently 9.8% of Americans less than 65 years of age who lack health insurance.7 There are various additional financial costs that impact women’s access to contraception, such as the cost of premiums, office co-pays, and needing time-off from work to schedule doctor appointments. Norgestrel is an option for uninsured and underinsured individuals, as it is priced at approximately $19.99 for a 28-day pack, $49.99 for a 3-month (84 pill) pack, and $89.99 for a 6-month (168 pill) pack.8,9
POPs such as norgestrel do not have estrogen, which is associated with the risk of venous thromboembolism (VTE), breast cancer, and cardiovascular events, such as hypertension, myocardial infarction, and stroke.10 ACOG indicates that progestin-only hormonal contraceptives “are generally safe and carry no or minimal risk of VTE” and the risk is smaller than methods with combined estrogen. POPs benefit patients unable to use estrogen products.6
Norgestrel must be taken the same time every day within a 3-hour window based on the normal time taken or it will not be effective for 2 days after a missed dose.11 Patients must use a non-hormonal backup method for 48 hours if a dose is missed. Common side effects (≥5% of subjects) include headache, abdominal pain or cramping, dysmenorrhea, acne, backache, breast tenderness, vaginal discharge, and delayed follicular atresia/ovarian cysts.11 About 7% of women will experience an unintended pregnancy during the first year of typical use, as ovulation may not be prevented every cycle.
Patients who take medications for pulmonary hypertension, HIV/AIDs, tuberculosis, or seizures should consult with a provider to check for drug-drug interactions. Norgestrel is contraindicated for those with liver disease or cancer, pregnancy, undiagnosed abnormal uterine bleeding, and known or suspected carcinoma of the breast or other progestin-sensitive cancers.11
Patients should be cautioned that up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptives are ectopic. Approximately 50% of women reported changes in menstruation, including breakthrough bleeding (48.6%) and spotting (47.3%) while taking norgestrel.11 Patients who are breastfeeding can take norgestrel; progestin can pass through breast milk and increase steroid levels in infant plasma, but no adverse effects have been reported in infants.11
If a pharmacist suspects a patient is purchasing this product who may be involved in human trafficking or domestic violence, the pharmacist should counsel the patient by asking open-ended questions regarding their safety. Incidences should be reported to the National Human Trafficking Hotline (1-888-373-7888) or National Domestic Violence Hotline (1-800-799-SAFE (7233)).
Rachel Chandra, PharmD, MPH, FASHP, is a clinical pharmacist practitioner and PGY-1 residency program director at the Dayton VA Medical Center in Dayton, Ohio.
Rachel Massey is a class of 2025 PharmD candidate at the Cedarville University Student Pharmacist, president of the Student College of Clinical Pharmacy, and a Kettering Health Intern at Wittenberg University.
Like other OTC products, there may be instances where there is misuse of products. The accessibility of norgestrel may potentially lead to patients taking a hormone for indications other than contraception, such as emergency contraception.12 There is a potential for adolescents to be taking this product without proper counseling and reproductive education.
The FDA outlined in a memorandum that norgestrel was approved as a prescription-to-OTC product based on clinical trials conducted in the 1970’s.13 The FDA outlines that new data were not needed for this product to be brought to retail shelves since safety and efficacy were established when the product was first approved.14 Based on the 8 trials from 1968 to 1973 used to approve norgestrel 0.075 mg in 1973 (formerly known as Ovrette), the FDA established that norgestrel is safe and effective.14,15
FDA reviewed the ACCESS trial and the ACCESS Self-Selection in Actual Use Study that demonstrated how patients can safely select or stop taking this product based on their understanding of the label.16,17 A requirement for the FDA to approve norgestrel was patients demonstrating that they could understand how to accurately use the product and when they are not a candidate for use.14 At least 90% of participants could understand how to take the medication and knew when to seek medical attention. Further, 79% understood when they were not a candidate for use based on norgestrel’s contraindications and warnings.14-17
The ACCESS trial reported efficacy of norgestrel 0.075 mg using the Pearl Index (PI), which is the proportion of females, out of 100, who become pregnant within a year of taking the product.16 The ACCESS trial reported a PI of 2.20 after 6 months of using norgestrel 0.075 mg. In the FDA reviewers’ analysis, the PI was 3.4 after 1 year.14 Based on these results, the FDA determined that norgestrel was proven effective as an OTC birth control option.14,15
Norgestrel is an OTC contraceptive option available for patients to prevent unintended pregnancies. The package labeling has been shown to be easy to understand by consumers. Norgestrel is affordable and available across the US in community pharmacies.
