The Food and Drug Administration is also considering a national over-the-counter clearance for the progesterone-only birth control pill, Opill, after an advisory meeting in May.
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History of over-the-counter hormonal birth control
The initial version of the birth control pill, Enovid, received FDA approval in 1957 for hormone regulation, marketed with the side effect of preventing pregnancy. It was not approved for the explicit purpose of contraception until 1960.
Washington was the first state in 1979 to allow pharmacists with collaborative practice agreements, or CPAs, with physicians to dispense hormonal birth control without a clinician’s prescription. CPAs more generally are voluntary arrangements between pharmacists and physicians that allow pharmacists to provide certain elements of patient care, including prescribing and monitoring medication usage. Michigan, Montana, and Tennessee allow for pharmacies to develop CPAs to increase access to contraception.
In 2013, California became the first state to pass a law allowing pharmacists to dispense hormonal contraception independently of physician guidance. The California statute was implemented in 2016 at the same time Oregon enacted similar legislation.
Health implications of over-the-counter hormonal contraception
A significant concern for dispensing hormonal contraceptives without a clinician is the potential to exacerbate undetected preexisting conditions with the new medication.
Although each state has different requirements, pharmacists are generally required to conduct a basic health screening prior to approving contraceptive use, which includes a blood pressure reading and examining the patient’s health history and current conditions.
Certain conditions, however, that can be accelerated by hormonal contraception cannot be tested by a pharmacist. Patients with a history of breast, cervical, and ovarian cancers are instructed to avoid hormonal birth control, but having an undiagnosed cancer while on birth control could advance the disease process more rapidly.
Although patients with uncontrolled high blood pressure are also ineligible for birth control pills, other cardiovascular conditions, such as blood clotting or liver conditions can be exacerbated by hormonal contraceptives.
While advocates of increasing access to contraceptives argue that there are more common complications with unintended pregnancy and abortion than hormonal birth control, others are concerned that the rate of severe consequences will increase without physician involvement and monitoring.
Progress of over-the-counter hormonal birth control
Since 2021, five states — Arizona, Delaware, Illinois, North Carolina, and South Carolina — have passed measures to allow pharmacists to dispense hormonal birth control and monitor the health of patients using the medication. The legislatures of Connecticut, Indiana, Maine, Massachusetts, New York, and Texas are considering measures to follow suit.
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A 17-person advisory panel for the FDA voted unanimously in May to suggest the medication Opill follow a similar pharmacist-approval process nationwide. Opill is different from other hormonal contraceptives in that it only uses low-dose progesterone instead of a combination of progesterone and estrogen to regulate hormone levels.
Although patients advised the FDA that the benefits of pharmacist-prescribed hormonal contraception outweigh the risks, including unintended pregnancy, the FDA is expected to release its decision by the end of the summer.
