People interested in using contraception continue to face barriers to access. Strategies such as over-the-counter (OTC) access, telehealth provision, and pharmacist prescribing may help to reduce these barriers for some people, especially when services are available at an accessible price or covered by insurance. The US Food and Drug Administration’s approval of Opill (norgestrel 75 mcg) as the first daily oral contraceptive for over-the-counter sale is an important precedent that may lead to the approval of other OTC hormonal contraceptives. Until all hormonal methods are available without a prescription, other strategies may help to improve access to these contraceptive methods.
Key points
- •
In July 2023, the US Food and Drug Administration approved Opill (norgestrel 75 mcg) as the first daily oral contraceptive (OC) for over-the-counter sale.
- •
Potential users are very interested in being able to access OCs without a prescription, and this model of care is safe and effective.
- •
Full insurance coverage of over-the-counter contraception would lead to more women using the product and a greater reduction in unintended pregnancy.
- •
Telehealth provision of contraception has expanded greatly since the coronavirus disease 2019 pandemic, although some people may face barriers to accessing telehealth.
- •
Approximately half of states have implemented pharmacist prescription of at least some hormonal contraceptives, a model that is also safe and well-liked by patients.
Introduction
A variety of factors contribute to nonuse of contraception, gaps in use, and early discontinuation of contraceptive methods. In a 2022 nationally representative survey of 2119 individuals assigned female at birth aged 15 to 44, 25.2% reported they were not using their preferred contraceptive method. Among the most common reasons for nonuse of their preferred method, the participants cited side effects (28.8%), sex-related reasons (25.1%), logistics and knowledge barriers (18.6%), safety concerns (18.3%), and cost (17.6%). In another study from a nationally representative sample, 30% of the women who had ever tried to obtain a prescription for hormonal contraception reported difficulties obtaining the prescription or refills.
The high cost of contraception was addressed partially by the contraceptive coverage guarantee under the Affordable Care Act, which mandates that most private insurances cover methods approved by the Food and Drug Administration (FDA) without cost sharing, such as co-payments or deductibles. But the prescription requirement may be another barrier to use that is no longer medically necessary, and removing this obstacle is an additional strategy to reduce unintended pregnancy.
In July 2023, the FDA approved Opill (norgestrel 75 mcg) as the first daily OC for over-the-counter (OTC) sale. Opill was approved for people of all ages, and it became available in pharmacies and online in March 2024. While this is an important advance in contraceptive access, some people may continue to face barriers to contraception. This article reviews the evidence related to removing the prescription barrier to contraception, the need to reduce financial barriers to OTC contraception, as well as other strategies to expand access to contraception, including through pharmacist provision and telehealth.
People’s interest in access to hormonal contraception without a prescription
The American College of Obstetricians and Gynecologists commissioned a national survey in 1993 to measure women’s attitudes toward OCs. In general, women thought the pill was less effective and more dangerous than it truly is, and 86% said OCs are not safe enough to buy OTC without seeing a physician first. Another survey was performed in 1995 at a college among female students, and 65% said OCs should not be available OTC.
More recent research has documented growing interest in removing the prescription barrier to contraception. In 2004, a nationally representative telephone survey explored women’s interest in pharmacy access to hormonal contraception. In this survey of 811 US women (aged 18–44), 68% of the women reported they would start the pill, patch, or vaginal ring if it were available directly in a pharmacy with screening by a pharmacist. Black and Latinx women were more than twice as likely as white women to express interest in pharmacy access. Interest was also higher among people living on low incomes and those who were uninsured.
A 2006 survey of 601 unsterilized women in El Paso, Texas, who were not currently using hormonal contraception or the intrauterine device (IUD) explored their interest in obtaining OCs over the counter in the United States. A total of 60% said they would be more likely to use OCs if the pill were available OTC in the United States. In a regression analysis, women not currently using a contraceptive method were more likely than users of nonhormonal methods to say they might use the pill if available OTC (adjusted odds ratio 1.54, P <.05).
A nationally representative survey in 2011 explored this topic with 2046 women aged 18 to 44 who were considered at risk of unintended pregnancy. Overall, 62% reported being strongly or somewhat in favor of OCs being available OTC, and 37% of respondents said they were likely to use an OTC OC if one were available. Another nationally representative survey in 2015 included 2026 sexually active adult women aged 18 to 44 not currently desiring pregnancy, as well was 513 female adolescents aged 15 to 17, and focused specifically on interest in an OTC progestin-only pill. In this survey, 39% of the adults and 29% of the teens said they would be likely to use an OTC progestin-only pill if one were available; this increased to 46% and 40%, respectively, if the OTC pill were covered by insurance. In multivariable analysis, there were no differences in interest by age, education, or race/ethnicity; those who were uninsured and those currently using OCs or a less effective method had significantly higher odds of interest in an OTC progestin-only pill.
People in most countries of the world are able to access OCs without a prescription. ( Fig. 1 ). In 2012 in 35 countries, OCs were legally available over the counter, and in another 11 countries, they were available without a prescription after a woman is screened for eligibility by a trained pharmacy staff person. In an additional 56 countries, OCs were available informally without a prescription despite the fact that they should require one. Only 45 of 147 countries surveyed required a prescription to obtain OCs.
Evidence regarding the safety of over-the-counter access to oral contraceptives
A great deal of evidence has established the safety of OCs, as well as a host of non-contraceptive benefits of the medication, including prevention of ovarian and uterine cancer. , While rare complications, such as myocardial infarction, stroke, and venous thromboembolism, have been associated with OC use, certain conditions have been identified that increase the risk of these adverse events while using OCs. The US Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use lists various conditions, including use of certain medications, and indicates whether a person with the condition is eligible for different contraceptives using 4 different categories.
Little research has documented the prevalence of these contraindications in the general public. One study of a sample of women aged 18 to 49 in El Paso, Texas, found that 39% of the women had at least 1 relative or absolute contraindication to combined hormonal contraception. The most common contraindications were hypertension and migraine headache with aura. Less than 2% had a contraindication to progestin-only pills. Other studies with women seeking contraception have found a much lower prevalence of contraindications to combined hormonal contraception. ,
Studies have demonstrated that women can accurately self-identify these contraindications using a simple checklist. A study in Washington State found agreement between women’s self-assessment of contraindications and the assessment of a clinician in 96% of cases (n = 399). In the study from El Paso referred to earlier, a self-screening checklist was found to be 83% sensitive to identify a true contraindication and had a negative predictive value of 89%.
While the checklist performed well, 7% of the women thought they were eligible for combined oral contraceptives (COCs) but were found to be ineligible by a nurse practitioner, generally due to unrecognized hypertension. A similar proportion of women thought they were ineligible due to severe headaches, but the nurse practitioner did not judge them to have the true contraindication of migraine with aura. The checklist was even more accurate to identify contraindications to progestin-only pills (POPs), with a negative predictive value of 99.6% (95% CI 99.0%–99.8%).
Given the fact that there are fewer—and rarer—contraindications to the progestin-only formulation compared to COCs, it is not surprising that the first OTC OC in the United States is a POP. Perrigo (originally HRA Pharma), the manufacturer of Opill, submitted research evidence to the FDA on the norgestrel OC as part of their application for nonprescription status, including label comprehension studies and self-selection studies. The label comprehension studies demonstrated that people understood the key messages of the label, and the self-selection studies showed that people could use the OTC Drug Facts Label to determine whether they were appropriate for the product or not. In a study of 1772 participants aged 12 or older, 6% were not medically eligible for norgestrel use according to the criteria on the label; among those deemed ineligible, 65% correctly self-assessed that they were ineligible, while 35% (n = 36) said the product was okay for them to use. Subsequent review by a panel of obstetrician/gynecologists determined that use would have been appropriate for 24 of the 36 people who had been classified an incorrect self-selectors, leaving 12 (0.7% of the total study population) who were medically contraindicated for use but thought they were appropriate after reviewing the label.
One study examined whether people could understand the key messages in an OTC Drug Facts Label for a COC product. In this study of 163 women, teens, and others with the capacity for pregnancy aged 12 to 49, the key messages in the OTC label were well understood; ≥95% of participants understood 10 of the 11 primary messages. Unlike for POPs, hypertension is a contraindication for COCs, and it is unclear if FDA might require documentation of recent blood pressure screening to approve an OTC COC.
Evidence regarding ongoing use of oral contraceptives in an over-the-counter environment
Even in the current system where a prescription is required, adherence to OCs is far from perfect. One study using an electronic device to measure adherence found that one-third of pill users missed 3 or more pills in a given cycle. One-year continuation of OCs is reported to be 67%.
No research has specifically documented the effectiveness of OCs in an OTC environment, although 2 studies have explored continuation of OCs in settings where they are available without a prescription. One study from Kuwait, where pills are available OTC, found that continuation was similar among women obtaining them without a prescription compared to those who consulted a physician. Another study from El Paso, Texas, compared women living in Texas who obtained OCs OTC in Mexican pharmacies across the border (n = 514) to women living in Texas who obtained pills by prescription in public clinics (n = 532). In a multivariable analysis, discontinuation was significantly higher for women who obtained pills by prescription compared to the OTC users (hazard ratio 1.6, 95% CI 1.1–2.3).
As part of the application for Opill’s approval, an actual use study was performed to assess adherence to the product’s label. The study included 883 participants, including 200 adolescents under age 18, who reported information in an e-diary about use. On 97% of days, participants either took a pill or took appropriate mitigating actions (such as not having sex or using a barrier method); 96% of participants reported taking the pill at the correct time (within 3 hours of the time of day of the previous dose). In this study, 6 participants conceived while taking Opill. Although the study was not designed to measure effectiveness, the findings on pregnancy in the study are consistent with data on failure of norgestrel OC in a prescription environment. Of note, in a follow-up survey with 665 participants in the Opill actual use study, 83% reported being likely to continue using the product if it were available.
Cost and insurance coverage of over-the-counter contraception
In 2022, the retail price for the branded OTC levonorgestrel emergency contraception (EC) product was as high as $60, with generics costing around $35. Because of the experience with EC, as efforts moved forward to introduce Opill, affordability of the product has featured prominently in the discussion among advocates. In the nationally representative survey in 2015 referred to previously, among people who said they were interested in using an OTC POP if one were available, the median maximum monthly price was $15 for adult women and $10 for those aged 15 to 17. These amounts are somewhat lower than the manufacturer’s suggested retail price for Opill, which is $19.99 for 1 month, $49.99 for 3 months, and $89.99 for 6 months, suggesting that the product may be inaccessible for some people living on low incomes. Perrigo has a cost assistance program available for people needing financial assistance ( https://opill.com/pages/cost-assistance-program ).
While it is true that insurance has traditionally not covered OTC medications, more and more insurances are covering at least some nonprescription medicines. Under the Women’s Preventive Services Guidelines of the Affordable Care Act (ACA), OTC contraceptives that are FDA-approved and used by women also must be covered by insurance without cost sharing. However, insurers may require a prescription to trigger such coverage, which obviously undermines any improvement in access afforded by making a method available OTC. Several states have passed legislation requiring insurance companies to cover OTC contraception without a prescription, and hopefully this trend will continue. A cost modeling analysis of a potential OTC progestin-only pill found that use would be highest and the estimated reduction in unintended pregnancy would be greatest (8%) if such pills were fully covered by insurance without cost sharing or otherwise available without out-of-pocket cost.
Possible disadvantages of over-the-counter access to oral contraceptives
Despite their strong support for OTC access to OCs, potential users have also expressed concerns ( Table 1 ). In addition to safety and cost, these concerns have primarily focused on whether users will continue to obtain recommended preventive screening, and whether OTC pills should be restricted to adults only. Clinicians have articulated similar concerns, as well as worries that the effort to make pills available OTC will undermine promotion of long-acting reversible contraception (LARC).
| Concern Regarding Over-the-Counter (OTC) Access to Hormonal Contraception | Mitigating Factors/Responses |
|---|---|
| Cost: Insurances historically have not covered OTC medications, and the out-of-pocket cost of OTC hormonal contraceptives could be high. |
|
| Adolescents: OTC access could result in teens having more unprotected sex or having sex at an earlier age; they also may not be able to follow instructions for an OTC product. |
|
| Preventive screening: people may not get recommended screening for cervical cancer or sexually transmitted infections if they do not have to come to a clinic to obtain hormonal contraception. |
|
| Counseling regarding long-acting reversible contraception (LARC): making hormonal contraception available OTC will promote methods less effective than LARC methods and reduce opportunities to counsel about LARC. |
|
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
