Originally published Summer Newsletter 2023. Written by Cayla Daniele, PA-C.
On average, women plan to only have two children in their lifetime, which typically encompasses about 3 years with pregnancy and postpartum periods.1 This means they will spend roughly three decades trying to prevent pregnancy during their reproductive years.1 Half of the pregnancies in the U.S. are unwanted, which equates to more than three million per year.2 Disparity in healthcare is a common theme on the battlefields of medicine, with contraception and women’s health among the front lines. As such, the unintended pregnancy rate for disadvantaged women is more than five times that of women with higher incomes.1 These harrowing statistics demonstrate just how important it is for women to have access to birth control without having insurance or waiting months for an appointment at their OB/Gyn office. Of course, the lofty goal would be for all women to have access to insurance and no wait lines for appointments, but this is just the raw reality of our current healthcare world. Providing women a safe and affordable option to help prevent unwanted pregnancy is a monumental step forward in expanding access for all women, allowing them to have agency over their own reproductive health.
On July 13, 2023, the U.S. Food and Drug Administration (FDA) approved the first over-the-counter (OTC), nonprescription birth control called Opill.3 This is a progestin-only contraceptive option, eliminating the estrogen component to avoid numerous contraindications that would have to be screened by a provider. For example, women who have a history of deep vein thrombosis, pulmonary embolism, migraines with aura, and breast cancer should not take contraception that contains estrogen. This pill has norgestrel, which is a progesterone-only option that helps to prevent pregnancy when used appropriately. Often, women in the office will ask me why the estrogen component is even in the pill. We don’t need estrogen to prevent pregnancy; the reason estrogen is in our common birth control pills is to help stimulate normal monthly menses. Progesterone is the piece that prevents pregnancy. Therefore, you can and should inform your patients that both combination and progesterone-only options have similar efficacy when taken correctly. The only caveat- without the estrogen there may be more breakthrough bleeding, and this is expected and not harmful.
The OTC pill is projected to be available sometime in early 2024, but no current information is available on the price point.4 One would imagine that, by providing better access to a broad range of women who are in poverty and without insurance, the price would be reasonable. The pharmaceutical company, HRA Pharma, has indicated a type of consumer assistance program that would allow some people to obtain Opill free of charge, an overwhelmingly positive consideration.4 For skeptics of this OTC pill, let’s put things into emotional context: a woman’s home has been ravaged by a wildfire in California. She flees her home, unable to take anything but the clothes on her back. She does not have her insurance card, and either way is unable to get an appointment for several months at her OB/Gyn office. She and her husband have 3 children they need to provide for and cannot fathom having another child. She wants to stay protected from an unwanted pregnancy but also wants to maintain her close relationship to her husband. She goes to the pharmacy and buys Opill OTC and only pays $5. What a relief she feels to have control over her future. This is one of the numerous examples of real-life women that would benefit from this.
The medical community, specifically American College of Obstetricians and Gynecologists (ACOG), has long supported nonprescription access to hormonal contraception and has praised the FDA for approval of Opill.5 This will reduce the number of unwanted pregnancies and subsequent abortions, but more importantly empower women to have agency over themselves and their reproductive health. Truthfully, this is really a step towards catching up with the rest of the world. It is currently sold over-the-counter across the globe in the UK, South America, Asia, and Africa, to name a few locations.3 Maybe not surprisingly, after reading the latter, the unintended pregnancy rate is significantly higher in the U.S. than many other developed countries.6 This pill should help to reduce that vexing discrepancy. The Hippocratic Oath denotes the four basic principles – of beneficence, non-maleficence, justice, and respect – for a patient’s autonomy. As healthcare providers we have a duty to not just our patients, but all people and our communities. The autonomy this provides women over their reproductive health is substantial and long-awaited in the tides of healthcare.
References
- Moving Forward: Family Planning in the Era of Health Reform. Guttmacher Institute, 3/2014. https://www.guttmacher.org/report/moving-forward-family-planning-era-health-reform.
- Unintended Pregnancy in the United States. Guttmacher Institute, 1/2019. https://www.guttmacher.org/fact-sheet/unintended-pregnancy-united-states.
- Rodriguez, A. Opill approval means greater access to birth control pills. What else does it mean? USA Today, 7/2023. https://www.usatoday.com/story/news/health/2023/07/15/opill-cost-coverage-over-the-counter-birth-control-pill-explained/70410053007/#:~:text=HRA%20Pharma%20says%20Opill%20may,pill%20and%20brand%2C%20said%20Dr.
- Andrews, M. Over-the-counter birth control is coming. Here’s what to know about cost and coverage. NPR, 7/2023. https://www.npr.org/sections/health-shots/2023/07/19/1188697657/over-the-counter-birth-control-is-coming-heres-what-to-know-about-cost-and-cover.
- ACOG praises FDA approval of over-the-counter access to birth control pill. ACOG, 7/2023. https://www.acog.org/news/news-releases/2023/07/acog-praises-fda-approval-of-over-the-counter-access-to-birth-control-pill#:~:text=ACOG%20has%20long%20supported%20OTC,a%20prescription%20to%20be%20filled.
- Singh S, Sedgh G and Hussain R, Unintended pregnancy: worldwide levels, trends, and outcomes, Studies in Family Planning, 2010, 41(4):241–250.
Photo Credit: Photo by Reproductive Health Supplies Coalition on Unsplash