By Lucas Berenbrok and Marian Jarlenski
On July 13, 2023, the U.S. Food and Drug Administration approved 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. 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 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 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 and a public health expert. 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, pharmacists are the most accessible members of the health care workforce. Nearly 90% of Americans live within 5 miles of a pharmacy. Throughout the COVID-19 pandemic, pharmacies have provided testing, vaccination and treatment for millions of people in the U.S., proving their worth 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 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 on the grounds of moral, ethical and religious beliefs.
For instance, in 2019, a pharmacist in Minnesota denied a patient emergency contraception, citing personal beliefs. As a result, the patient drove 50 miles to gain access to the medication. 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 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 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 when it comes to offering prescription abortion pills in the post-Roe era.
Ongoing legislation seeking to reduce abortion access 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, 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.
Lucas Berenbrok is Associate Professor of Pharmacy and Therapeutics at the University of Pittsburgh. Marian Jarlenski
Associate Professor of Health Policy and Management at the University of Pittsburgh
Skibum says
This pill was approved by the FDA 50 years ago, but only now is being approved to be sold as an over-the-counter pregnancy prevention medication? Well, its another step in the right direction, but we are so woefully behind the curve in our collective thinking and application of fair and equitable measures that could and would be much more effective in pregnancy prevention except for one glaring factor. Take Iowa for example, the latest GOP state legislature that only one day ago passed new legislation to ban nearly all abortions in that state after 6 weeks. These 6-week bans fly in the face of medical evidence that most women don’t even know they are pregnant yet at that point in a fetus’ early development in the womb. One Iowa state legislature has been saying in interviews on TV after this latest GOP ban passed, that you should not have sex unless you are prepared for the prospect of making a baby. So, of course, like always, the conservative male lawmakers of the GOP do what they do best… they enact laws to hold only women accountable for pregnancies while never even acknowledging the obvious, that it takes a male also, who is just as responsible as the female, a 50-50 combination if you will, to create a baby. If the GOP wanted to be fair and equitable, or REALLY stop unwanted pregnancies, the Iowa GOP supermajority in both houses of that state’s lawmaking body could have banned the sale of condoms and the little male enhancement pills to men who live in Iowa. Just who do they think they are kidding? Just like here in our Nazified state under Oberfuher Deathsantis and his gerrymandered GOP supermajority in the state legislature, we have become just another in a growing list of states that have put a huge, overbearing and powerful, unfair and inequitable burden on women’s bodies while completely ignoring the man’s role in impregnating women. While women still are allowed to vote, wait… they are actually allowed to vote in all 50 states, (at least as of today) aren’t they, GOP legislatures? Anyway, I implore ALL women to stand up and demand that these GOP dominated and gerrymandered state legislatures acknowledge the plain and simple fact that it takes a man’s overt act just as much as a woman’s overt act to start a pregnancy. Demand that laws treat men and women equally! If they are going to enact laws to place restrictions on women being able to obtain an abortion, then demand that they also restrict the sale of condoms and the little blue pills that so many men are fond of using so much. After all, as the Iowa legislator has just said, nobody should be having sex unless they are prepared to have a baby. So GOP legislatures, put your laws where your mouths are, and enact some fair and equitable, common sense laws that hold MEN equally responsible and accountable for the unwanted pregnancies THEY cause by having sex with women when men have no interest or desire to make a baby, and to raise and support that child. Get it done or get lost!
Laurel says
Skibum: You are my new BFF! :)
If I followed the Iowa logic, I would still be a virgin as I never intended to have kids. Wow. You are absolutely correct when you state they should ban the little blue pill as an equitable response to their laws. I imagine that all those GOP men only have sex to make babies. Sure. This is clearly a furthering attack on women’s rights.
Also, why the hell does a pharmacist’s personal beliefs come into the picture at all? So, if someone has surgery, and the doctor prescribes opioids for pain (this happened to me, and I never had a problem with it) the pharmacist can turn the patient down because he/she thinks opioids are bad? No, we don’t hear any mention of that. So, it’s obvious that women are again targeted by the GOP. Control women, take away their ability to care for their own bodies with their doctor’s help. The GOP is in your bedroom folks, a previous taboo.
Sherry says
@Skibum. . . yet another excellent, well reasoned appeal to equality and justice!
Unfortunately, the millions of brainwashed, chauvinistic, Viagra dependent men who still “control” our country will not listen to you. Their lust for power is enhanced by keeping women as insecure, second class citizens.
What does it say that generic Viagra products have been available without a prescription, delivered to your door, with a couple of clicks on the internet for years. . . Yet, it has taken all this time to make birth control pills readily available???
BTW. . . Birth control pills have been available without a prescription in many other countries for over 30 years. . . since last century.
Skibum says
Laurel and Sherry, there are many other men besides myself who support women and equal rights. I keep hearing there are actually more women voters than male voters. It would be wonderful if the women of America who are so brainwashed by the GOP would somehow get an epiphany and wake the hell up before they are forced into wearing “The Handmaids Tale” clothing and not even being allowed to have brains of their own. I still hope for a better future for all.
Sherry says
Thanks Skibum. . . I’m so very fortunate to be married to a wonderful man who is also very supportive of women and equal rights for all.
It wasn’t easy for us to leave our home state of Florida for California. My guy stepped up though and moved to a place he had not lived before, based on his trust of me and what I had told him of “my” experience in living in Marin county, CA for 20 years. It’s like moving to a different (much better for us) planet, and we haven’t regretted it for one moment. Enlightened/evolved/woke thinking. . . what a concept!!!
Good on you and Laurel (and many others) for continuing to present such factual and well reasoned analysis in the daily culture wars. . . especially when you continue to be surrounded by fear and hate filled brainwashed cult members. Keep Up Your Good Works! If you manage to bring even 1% back to “thinking” reality, you will have made a huge contribution to humanity, sanity and Democracy!