Over-the-Counter Birth Control Pills Could Be Approved Next Year

Over-the-Counter Birth Control Pills Could Be Approved Next Year

The following essay is reprinted with permission from The ConversationThe Conversation, an online publication covering the latest research.

The U.S. Food and Drug Administration is set to review a drugmaker’s application for the first over-the-counter birth control pill in November 2022, with a decision expected in the first half of 2023.

An over-the-counter hormonal contraceptive product that is approved would not need a prescription. would also be considered self-care ,, defined as “the practice where individuals look after their own health using all the information and knowledge .”

Currently, in many states of the United States, pharmacists are able to prescribe hormonal contraception without a prescription. 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 will issue a prescription. If not, the pharmacist will refer the patient to a doctor.

The FDA’s approval of an over-the-counter birth control pill will further expand options for people seeking hormonal contraception to all 50 states. The first such over-the-counter pill–a non-estrogen, progestin-only contraceptive–could become available by mid-2023.

We are a pharmacist and a public health expert. We see the shift to over-the-counter contraception as a significant step towards equitable and accessible reproductive health care for all Americans. Pharmacists will play an integral role in that effort.

The FDA will consider the application from HRA Pharma in November 2022.

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 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.

Historically, hormonal contraception, also known as birth control or “the pill”, was only available after a thorough medical evaluation by a doctor, physician assistant, or nurse practitioner.

But in 2016, California and Oregon became the first states 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 nonprescription-based, over-the-counter birth control is important because it will greatly lessen some of the known barriers to birth control. 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 accessibility 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 or the need to travel long distances to get such care.

However, it is important to remember that over-the-counter hormonal birth control does NOT replace regular office visits and discussion about reproductive health with doctors.

The use of contraception was illegal in the U.S. from the late 1800s until the 1960s.

Addressing remaining barriers

Patients may still encounter barriers, even in states where pharmacists can prescribe birth control.

For example, pharmacists might not participate if state policies don’t provide payment options to reimburse them for their time to prescribe and counsel. Also, pharmacists may not be available at all times and may not be available during the hours advertised for.

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. A jury found that the pharmacist did no discriminate against the woman by refusing to fill her prescription.

This precedent suggests that pharmacists who object the use of hormonal contraception may also choose not to prescribe it, even if allowed by state law. They might also decide not to sell over the counter birth control when it becomes available.

Pharmacist ‘conscience clauses’

Notably, many states allow pharmacists autonomy in dispensing medication. 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. The American Pharmacists Association encourages pharmacists to “step aside”, but they should not “step in front” of selling or dispensing medications that are contrary to their personal beliefs.

Some states have conscience clauses that require pharmacists to refer patients to another pharmacy if they refuse to dispense medication for moral or ethical reasons. Company policies may also require pharmacists who have objections to dispense medication to arrange for another pharmacist to provide the care and medication requested by the patient. The American Pharmacists Association suggests that not all states require a system to ensure patient access.

Contraception deserts

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 can be reduced or eliminated in states that allow pharmacists to prescribe contraception or in areas where hormonal birth control is available in community pharmacies.

We believe that pharmacists can positively contribute towards the safe, effective, and accessible use contraception in the country.

This article was originally published on The Conversation. Read the original article.


    Lucas Berenbrok is an associate professor of pharmacy and therapeutics at the University of Pittsburgh Health Sciences.

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