The US Food and Drug Administration will review a pharmaceutical company’s application for the first over-the-counter contraceptive in November 2022, with a decision expected in the first half of 2023.
Approved OTC hormonal contraceptive products do not require a prescription and are considered self-care defined as “the practice of health-conscious persons using available knowledge and information.”
Pharmacists in many US states can now prescribe hormonal contraceptives that require a prescription. The process begins with a consultation with a pharmacist to assess the patient’s eligibility, collect a medical history, and measure blood pressure. If the patient is eligible, the pharmacist can write the prescription. Otherwise, the pharmacist will refer the patient to the doctor.
FDA approval of an over-the-counter oral contraceptive provides more options for people seeking hormonal contraceptives in all 50 states. The first over-the-counter progestin-only oral contraceptive without estrogen could be available in mid-2023.
We are pharmacists and public health experts. We believe the transition to over-the-counter contraception is an important step toward affordable and equitable reproductive health care for all Americans, and pharmacists will play an integral role in this effort. Making contraceptives more accessible
With more than 60,000 pharmacies across the country, pharmacists are among the most accessible healthcare professionals. Nearly 90% of Americans live within 5 miles of a pharmacy. Pharmacies are testing, immunizing and treating millions of people in the United States during the COVID-19 pandemic, demonstrating their value in supporting and sustaining important public health initiatives.
Traditionally, hormonal contraceptives, also known as birth control, or “the pill” when taken orally, were only available after a complete physical examination by a doctor, paramedic, or nurse.
But in 2016, California and Oregon became the first states to allow pharmacists to prescribe birth control. It quickly expanded to 20 states and Washington, D.C., and now pharmacists can prescribe some form of birth control, including pills, patches, rings and injections.
However, it is important to switch to over-the-counter birth control pills. This greatly reduces some of the known barriers to contraception. These barriers include the inability to pay for clinic visits required to obtain a prescription, the lack of insurance to cover the cost of prescription contraception, or the inability to access contraceptives prescribed by pharmacists.
OTC contraceptives also lower barriers to access by eliminating the need to schedule appointments with a family doctor during business hours and the need to travel long distances to receive such care.
However, it is important to note that the availability of over-the-counter hormonal contraceptives does not negate the importance of regular doctor visits and discussions about reproductive health. remove remaining barriers
Even in states where pharmacists can now prescribe birth control, patients may still face barriers.
For example, pharmacists may opt out if public policy does not provide payment methods to reimburse pharmacists for time spent preparing prescriptions or consultations. In addition, pharmacist availability and hours of operation are limited and may be more restricted than the pharmacy’s advertised open hours.
Finally, pharmacists have been known to deny patients access to emergency contraception, also known as the “morning after pill,” and base medical abortion prescriptions on moral, ethical, and religious beliefs.
For example, in 2019, a Minnesota pharmacist denied a patient emergency contraception, citing personal beliefs. As a result, the patient traveled 50 miles to access the drug. The jury ultimately concluded that pharmacists did not discriminate against women by refusing prescriptions.
This precedent suggests that pharmacists who oppose the use of reproductive aids may refuse to prescribe hormonal contraceptives, even if permitted by state law. You can also decide not to sell the product when it becomes available.
It is worth noting that many states provide cars for pharmacists.