FDA approves first daily over-the-counter birth control pill, Opill – a pharmacist and public health expert explain this new era in contraception

On July 13, 2023, the U.S. Food and Drug Administration approved^[1] a drugmaker’s application for the first daily over-the-counter birth control pill for people seeking to prevent pregnancy.

The pill, called Opill – the brand name for the tablet formulation of norgestrel – is an oral contraceptive containing only progestin hormone, which helps prevent pregnancy by thickening cervical mucus, preventing ovulation or both. Opill was initially approved by the FDA for prescription use in 1973^[2]. Its approval for nonprescription use may spark other manufacturers of prescription-only birth control to follow. This highlights the importance of pharmacies as destinations for health care and pharmacists as facilitators of contraceptive care.

Opill is expected to be available through pharmacies, supermarkets, convenience stores and online retailers in early 2024. The FDA’s approval of an over-the-counter birth control pill can further expand options for people seeking hormonal contraception to all 50 states and U.S. territories. This expanded access could be a significant development in the post-Roe era as individual states further restrict^[3] women’s access to abortion.

Prior to the FDA’s approval of this pill, many U.S. states have allowed pharmacists to prescribe hormonal contraception. The process begins with a pharmacist consultation^[4] to screen patients for eligibility, collect a medical history and measure blood pressure. If the patient qualifies, the pharmacist can provide a prescription to the patient; if not, the pharmacist refers the patient to a physician.

We are a pharmacist^[5] and a public health expert^[6]. We see the move toward over-the-counter birth control as an important step toward accessible and equitable reproductive health care for all Americans. Even though this product will be over-the-counter, pharmacists will play an indispensable role in that effort.

Making birth control more accessible

With more than 60,000 pharmacies nationwide^[7], pharmacists are the most accessible members of the health care workforce. Nearly 90% of Americans live within 5 miles of a pharmacy^[8]. Throughout the COVID-19 pandemic, pharmacies have provided testing, vaccination and treatment for millions of people in the U.S., proving their worth^[9] in supporting and sustaining initiatives that are important to public health.

Traditionally, hormonal contraception – also known as birth control, or when taken orally, “the pill” – has only been accessible after a comprehensive medical evaluation by a physician, physician assistant or nurse practitioner.

But in 2016, California and Oregon changed their legislation to allow pharmacists to prescribe birth control. That quickly expanded to 20 states, plus Washington, D.C., that now allow pharmacists to prescribe^[10] some form of birth control, whether it be the pill, patch, ring or shot.

However, the move toward over-the-counter birth control is important because it will lessen some of the known barriers to birth control, especially if the products are offered at an affordable price point. These barriers include the inability to pay for medical office visits required to obtain a prescription, lack of insurance to cover the cost of prescription birth control or lack of access to pharmacist-prescribed contraception.

Over-the-counter birth control can also reduce access barriers by preventing the need for a scheduled appointment with a primary care physician during work hours, the need for a pharmacist to be present to dispense prescription birth control or the need to travel long distances to access these professionals.

But it is important to note that over-the-counter access to hormonal birth control does not replace the importance of regular office visits or discussion about reproductive health with physicians.

Addressing remaining barriers

Even in states where pharmacists are currently allowed to prescribe birth control, over-the-counter hormonal birth control can make a difference.

For example, if state policies do not create payment pathways to reimburse pharmacists for their time to counsel and prescribe, pharmacists may choose not to participate in prescribing birth control. Additionally, pharmacist availability and time may be limited and more restricted than the hours a pharmacy is advertised as open to the public to sell over-the-counter birth control products.

Finally, there are notable cases of pharmacists who have denied patients access to emergency contraception, also known as the “morning-after pill,” and prescriptions for medication abortion^[11] on the grounds of moral, ethical and religious beliefs.

For instance, in 2019, a pharmacist in Minnesota denied a patient emergency contraception^[12], citing personal beliefs. As a result, the patient drove 50 miles to gain access to the medication^[13]. Ultimately, a jury found that the pharmacist did not discriminate against the woman by denying to fill her prescription.

This precedent suggests that pharmacists who object to the use of reproductive medications may further choose not to participate in prescribing hormonal contraception even when permitted to do so by state law. Individuals may also choose not to stock over-the-counter birth control when it becomes available.

Pharmacist ‘conscience clauses’

Notably, many states give pharmacists autonomy when dispensing medications. Currently, 13 states have laws or regulations known as “conscience clauses” that permit pharmacists to refuse to dispense a medication^[14] when it conflicts with their religious or moral beliefs.

The American Pharmacists Association also recognizes an individual pharmacist’s right to conscientiously refuse to dispense a medication; however, the organization supports a system to ensure patient access to medications^[15] without compromising the pharmacist’s right of refusal. In other words, pharmacists are encouraged to “step aside” but should not “step in the way” of dispensing or selling medications that conflict with their personal beliefs.

Some states with conscience clauses legally require pharmacists to refer patients elsewhere when they decline to dispense a medication for ethical and/or moral beliefs. In addition, company policies may require pharmacists with objections to arrange for another pharmacist – who does not have objections – to provide the medication and care requested by the patient. However, some states do not require a system to ensure this patient access as the American Pharmacists Association suggests.

Pharmacist conscience clauses are unlikely to interfere with over-the-counter birth control availability at large pharmacy chains, supermarkets and mass merchandisers due to top-down decision-making structures of these organizations. However, national pharmacy chains have recently faced complicated legal and political situations^[16] when it comes to offering prescription abortion pills in the post-Roe era.

Ongoing legislation seeking to reduce abortion access^[17] in the post-Roe era across the U.S. only increases the importance of patient access to contraception. Geographical spatial analyses have found that people of low socioeconomic classes and of color disproportionately reside in contraception deserts^[18], which are areas with low access to family planning resources. These contraception deserts could be reduced or eliminated altogether now that retailers may sell over-the-counter hormonal birth control at an affordable price.

Pharmacists’ role in providing contraceptive

Although patients may seek and purchase over-the-counter hormonal birth control at locations other than community pharmacies, when patients come to a pharmacy, pharmacists can help them understand how to use the product correctly, safely and effectively prior to purchase. Pharmacists are trained as medication experts and acquire unique knowledge and skills of self-care products and nonprescription medications. When a pharmacist feels it is necessary, they can refer patients who do not qualify for over-the-counter birth control use back to their primary care providers for further evaluation and care.

In our view, pharmacists can positively contribute to the safe, effective and accessible use of contraception across the country.

This is an updated version of an article originally published^[19] on Oct. 28, 2022.

References

1. ^{^} U.S. Food and Drug Administration approved (www.fda.gov)
2. ^{^} by the FDA for prescription use in 1973 (www.fda.gov)
3. ^{^} individual states further restrict (theconversation.com)
4. ^{^} with a pharmacist consultation (birthcontrolpharmacist.com)
5. ^{^} pharmacist (scholar.google.com)
6. ^{^} public health expert (scholar.google.com)
7. ^{^} With more than 60,000 pharmacies nationwide (doi.org)
8. ^{^} 5 miles of a pharmacy (doi.org)
9. ^{^} proving their worth (theconversation.com)
10. ^{^} allow pharmacists to prescribe (naspa.us)
11. ^{^} prescriptions for medication abortion (www.npr.org)
12. ^{^} denied a patient emergency contraception (www.nbcnews.com)
13. ^{^} to gain access to the medication (www.washingtonpost.com)
14. ^{^} permit pharmacists to refuse to dispense a medication (www.nbcnews.com)
15. ^{^} ensure patient access to medications (aphanet.pharmacist.com)
16. ^{^} complicated legal and political situations (www.nytimes.com)
17. ^{^} legislation seeking to reduce abortion access (www.guttmacher.org)
18. ^{^} disproportionately reside in contraception deserts (read.dukeupress.edu)
19. ^{^} article originally published (theconversation.com)