​Necessary access, ‘OTC’

Rates of unintended pregnancy are shockingly high in the United States. Of all pregnancies in the US, 50 percent are unintended. While many unintended pregnancies come to be desired, significant emotional, financial, and health concerns accompany an unplanned pregnancy. An unintended pregnancy is associated with an increased risk of late prenatal care, as well as fetal exposure to alcohol and tobacco. In the United States, the most common method of contraception is the oral contraceptive pill (OCP), used by 28 percent of women. American women must receive a prescription in order to obtain OCPs. This requirement creates an unnecessary barrier to access and does not protect patients. Removing the prescription requirement for OCPs would be safe, has global and national precedent, and would help to reduce the rate of unintended pregnancy.

Oral contraceptive pills are available without a prescription in nearly 70 percent of countries and the majority of the world’s population lives in a country with over-the-counter (OTC) access. Women who rely on the pill have half the risk of pregnancy compared to those who rely on condom usage. The American College of Obstetricians and Gynecologists and the American Academy of Family Physicians have both released statements in favor of over-the-counter distribution of OCPs. In a national survey, 5 percent of women at high risk for an unintended pregnancy stated that nonuse of contraception was because of lack of time for medical visits. Furthermore, in a national study conducted in 2004, half of women at high risk of unintended pregnancy stated they would begin using an oral contraceptive if it could be obtained in a pharmacy without a prescription.

In general, medications require a prescription when their safe use necessitates oversight by a medical provider. However, there is no compelling evidence that OCP use must be supervised in order to be safe. Other than obtaining a blood pressure measurement, all contraindications to OCP use are derived from a woman’s medical history. Can women effectively identify these contraindications from their own medical history without the help of a medical provider?

Overwhelmingly, yes. A study of women’s’ ability to self-screen for OCP safety, conducted in the United States, found that only 0.4 percent of women fail to identify a contraindication found by a provider. Another study, conducted in the United Kingdom, found that women take a more conservative approach than clinicians when screening for contraindications to OCP use. Of the 328 women who self-screened, none would have taken oral contraceptive pills inappropriately. Thus, evidence shows that women can effectively self-screen for factors derived from their own medical history. About 6 percent of women aged 19-49 do have undiagnosed hypertension, however, blood pressure screenings do not need to be conducted by a physician and could be conducted by pharmacists or certified medical assistants. Thus, it seems entirely feasible to rely on women to self-screen for contraindications based on their medical history and on allied health providers to perform blood pressure measurements.

Additionally, OCPs meet several other key specifications that the FDA requires when any drug switches from prescription to over-the-counter status, which has occurred with proton pump inhibitors such as Prilosec. Oral contraceptive pills do not have significant toxicity if overdosed, and pose less of an overdose risk than aspirin and acetaminophen. Furthermore, there is no addictive potential.

Implementing over-the-counter access to OCPs could have a crucial role in addressing America’s high rate of teenage pregnancy. Teens represent a demographic where the prescription requirement is particularly burdensome, and where the risk of experiencing adverse events from OCP use is the lowest. Among women aged 15-19, 82 percent of pregnancies are unintended. The United States has a much higher teen pregnancy rate than other industrialized nations. Compared to their international peers, US teens are more likely to rely on ineffective methods such as condoms and withdrawal and are less likely to use highly effective contraception, such as OCPs or intrauterine devices. Most teens wait over 1 year after initial intercourse before visiting a physician to obtain an OCP prescription; up to 50 percent of adolescent pregnancies occur within the first 6 months after initial intercourse. OTC access would offer teens anonymity and convenience, likely leading to increased use of more effective methods of contraception.

There is some concern that insurance companies will not cover OCP costs if the medication is obtained OTC. This could create a dual system where some women obtain OCPs in pharmacies by paying out-of-pocket for the full cost of the medication. For a premium, they would gain convenient access to the medication. Women with less financial resources would still need to obtain a prescription in order to have insurance coverage for the cost of the medication. However, there is past precedence for insurance coverage of OTC products; most insurance companies still cover OTC antihistamines and nicotine replacement therapy. Additionally, all but one state Medicaid program offers coverage for some OTC medications.

Two states, Oregon and California, have passed laws that allow women to obtain birth control without a prescription by a doctor, after undergoing a brief consultation with a pharmacist. In California, adoption of the law has been limited, with as few as 100 of the 7000 pharmacies in the state participating the program. The California law has no mechanism for compensating pharmacists for time spent evaluating patients. In Oregon, pharmacists are reimbursed for their consultation time, with a fee that Medicaid and some other insurers will cover. In both states the cost of the OCPs is still covered by insurance.