Now is the time for over-the-counter hormonal contraception

Though her face was covered with a mask, her frustration was clear. As a 38-year-old woman who had recently moved to the United States with her husband for an exciting job opportunity, she has been taking combined oral contraceptives (COCs) reliably for the past 20 years with no pregnancies.

In Brazil, she would simply walk into her neighborhood store and buy a pack of COCs along with her shampoo. She had known for her whole life that she didn’t want children and remained highly motivated to avoid pregnancy, especially now that she is in America and had a chance to further her career beyond what she could achieve in Brazil.

I met her amid a global pandemic, as she had been granted an urgent appointment to our otherwise closed outpatient clinic due to an early undesired pregnancy. The last physician she saw would only provide her with 1 month of COCs to carry her over until she could be seen for an annual exam.

This single pill pack ended as the COVID-19 pandemic reached our state and the stay-at-home order was initiated. She was unable to get a refill from the initial prescribing physician and, though she tried to be careful, ultimately conceived.

The current COVID-19 pandemic has amplified the existing unnecessary barriers to contraception, much to the detriment of women. My patient wasn’t alone in her interest in over-the counter (OTC) contraception.

A survey nearly 10 years ago in the United States demonstrated that two-thirds of women were in favor of the concept and one-third would utilize it themselves.¹

A recent survey of over 2,000 women and 500 adolescents in the United States revealed that nearly 40% and 30% of each group would be interested in OTC progestin-only pill (POP) access.²

Now is the time to give women like my patient access to hormonal contraception over the counter.

In the United States, there are an estimated 43 million women at risk of unintended pregnancy.3 Prescription-based contraceptive methods are actively used by nearly one-third of contracepting women, and four of five sexually experienced women have used an oral contraceptive (OC) pill at some point in their lifetime.^3,4

Although physicians are typically most familiar prescribing OCs, the transdermal patch, and the monthly vaginal ring, there is also a self-administered subcutaneous form (104 mg) of depot-medroxyprogesterone acetate (DMPA) that can be directly prescribed to women.5

With the subcutaneous formulation, women can self-inject their DMPA via a small 3/8-inch needle without requiring an in-person visit for the standard 150mg intramuscular injection (Figure 1).⁵

Barriers to accessing hormonal contraception

Unfortunately, women experienced a multitude of barriers to prescription-based contraception long before the COVID-19 pandemic. One large survey of US women currently on prescription methods including OCs, the transdermal patch, and monthly vaginal ring, revealed that one-third of them had experienced access barriers while initiating or continuing their chosen method.⁶

Of the women who reported barriers, the vast majority (62%) were related to the physical need to see a provider in an office to obtain a prescription. Other factors such as cost (25%), pharmacy access (7%), and non-specified barriers (6%) were significantly less common.⁶

Our specialty has successfully overcome the limitations of prescription status on access to reproductive health services, specifically in the context of oral levonorgestrel emergency contraception. Although initially prescription-only when approved by the US Food and Drug Administration in 1998, oral levonorgestrel emergency contraception (EC) was given OTC status in 2006 for women age 18 and above.⁷

In 2013, the age restriction was removed so anyone with reproductive potential could access this form of EC.⁷ After transitioning to OTC status, adult use of oral levonorgestrel EC increased from 4% of women in 2002 (prior to OTC conversion) to 11% of women by 2010, amounting to a total of 5.8 million women who had ever used this product.⁷

Since the day-to-day intricacies of women's lives vary tremendously, we need a multitude of ways that they can access their preferred contraceptive method. Some women may still prefer in-office visits, but our experience with the OTC transition of oral levonorgestrel EC showed that women need the option to buy contraceptive methods directly off the shelf.

Overcoming access barriers

As an intermediate step toward OTC status, some states have given pharmacists the ability to provide hormonal contraception directly to people without a prescription from a provider. Through this behind-the-counter model, the pharmacist performs a risk assessment and sometimes a blood pressure measurement prior to dispensing combined hormonal contraception (CHC) (COC), transdermal patch, monthly vaginal ring).

The most recent tally shows that 13 states along with Washington, D.C., allow pharmacists to directly dispense some types of hormonal contraception.⁸ Nuances of behind-the-counter provision vary. Only nine of these states (along with Washington, D.C.,) allow the pharmacist to give the method directly to the patient without any prescriber involvement.⁸Four states actually require a collaborative practice agreement between pharmacists and providers, creating another possible barrier.⁹

Though a step in the right direction, behind-the-counter hormonal contraception still has its limitations. Pharmacist reimbursement for their patient assessment and counseling has also been a logistical obstacle and potential disincentive.¹⁰

Figure 1. Self-injection of subcutaneous depo medroxyprogesterone acetate 104 mg. Obtained from FDA label: Pfizer. Depo-SubQ Provera 104 (medroxyprogesterone acetate) injectable suspension, for subcutaneous use [package insert]; 2019. U.S. Food and Drug Administration website https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s031lbl.pdf

These visit costs can get passed down to patients. In addition, we know that women experience pharmacist objection to dispensation of reproductive health products such as EC and this is will likely occur with other contraceptive products.¹¹

A variety of health care organizations and private companies have tried to address theseaccess barriers and created systems of online contraceptive consultation with mail-order products. Women undergo standard health screening, with variation in other requirements like recent blood pressure measurement.

Sites also often charge women a separate consultation fee and vary in insurance acceptance. Importantly, women may find it difficult to obtain a clear estimate of insurance coverage. Some sites offer a clear low-cost cash option so women can gauge this option as a back-up if their insurance coverage is limited.

Online hormonal contraceptive access is a convenient option for many women, but there is still a large cohort for whom this is not an option. Access to online hormonal contraception changes depending on which state a woman orders her method from since legal restrictions vary widely.

States with restricted online contraceptive access are typically those with restrictive laws regarding in-person contraceptive provision or insurance coverage, so online access cannot totally overcome geographic disparities.

Though most women have Internet access to visit these websites, translating the online encounters into actual in-hand contraception can pose additional challenges. Requiring an electronic method of payment may be a barrier to some people. Women and adolescents can have challenges obtaining electronic methods such as credit cards for a wide range of reasons.

Privacy is still a risk with obtaining online contraception, whether through the electronic record of the transaction or the risk of a package being opened or intercepted at home. Those facing reproductive coercion or domestic violence are particularly at risk and lose the opportunity to have their method in hand right away so they can take necessary precautions.

The need for a stable mailing address also poses a barrier to those with housing instability. In the COVID-19 pandemic, widespread shipping delays can lead to gaps in contraception and thus pregnancy risk. Only OTC availability can give women rapid access to hormonal contraception that they can control immediately from time of acquisition.

Support for OTC hormonal contraception

Even before the COVID-19 pandemic abruptly exacerbated contraceptive access barriers, the American College of Obstetricians and Gynecologists (ACOG) published a committee opinion in support of OTC hormonal contraception 8 years ago.¹² In the realm of oral contraceptive access, the OTC movement has been long in existence, with a broadly inclusive, multidisciplinary OC OTC working group founded over 15 years ago.¹³

Professional organizations providing their support include ACOG, the American Academy of Pediatrics, American College of Nurse-Midwives, American Nurses Association, Association of Physician Assistants in Obstetrics & Gynecology, and Society of Adolescent Health and Medicine.¹³

Figure 2: Potential self-screening tool for combined hormonal contraception initiation

A wide range of reproductive health advocacy groups and justice organizations serve as partners in addition to university-based researchers and experts in the field.¹³ The American Academy of Family Physicians has maintained a clear position statement in favor of OTC hormonal contraception and makes the important distinction that insurance should provide coverage for these medications regardless of prescription or OTC status.¹⁴

Despite long-standing interest in OTC hormonal contraception, we are greatly limited in our ability to conduct research due to FDA restriction of these medications as prescription-only.

As a result, we draw upon a growing body of literature from international contexts to supplement our domestic survey research. It is important to note that the United States is in the minority when it comes to restricting hormonal contraception to prescription-only status, with one global assessment revealing that only 45 of 147 countries have this limitation.¹⁵

On a population level, the majority of the world’s population resides in countries with OTC access.¹⁵ Although OTC access is a common approach to hormonal contraception, there are important safety considerations as with all medications.

Practical aspects of OTC transition

Switching a prescription-only hormonal contraceptive to OTC would require initial action from drug manufacturers. The company would need to submit a new drug application to the FDA that includes a risk assessment of the medication when accessed OTC and a risk-benefit assessment for consumers.

Medication label and package inserts will be particularly important with OTC hormonal contraceptives as they would include self-screening instructions along with typical dosing and adverse effect information. Drug manufacturers and the FDA would need to ensure this information is comprehendible based on consumer reading levels and that it translates to correct contraceptive use.^16,17

Self-assessment of medical eligibility

Hormonal contraceptives are safe for the vast majority of women and adolescents. In a switch from provider-guided assessments, OTC provision will require individuals to self-screen for their own eligibility for both progestin-only and combined estrogen/progestin methods.

Venous thromboembolism (VTE) risk is a common safety concern with hormonal contraceptives. Fortunately, progestin-only methods, which include the progestin-only pill and subcutaneous depot-medroxyprogesterone acetate injection, carry no or minimal risk of VTE and do not require any in-person evaluation prior to initiation.^18-20

Estrogen-containing methods, which include COC, monthly vaginal ring, and transdermal patch, do carry a comparatively increased VTE risk in certain populations.²⁰ However, the marginal increase in VTE risk among COC users is significantly lower than pregnancy or the postpartum time period.¹⁸

OTC hormonal contraceptives would contain a checklist that potential purchasers could use to screen for medical conditions that would caution against self-use of these medications, particularly those that contain estrogen (Figure 2).

Overall, studies have demonstrated that women tend to overestimate the risk of hormonal contraception and are more likely to restrict their own use more than what a medical provider would recommend. In one study, 6.9% of women reported contraindications to combined hormonal contraception while only 2.4% actually had a real contraindication on chart review.²¹

Women in one study in the United Kingdom were so accurate in their self-assessment that none of the over 300 women included would have taken hormonal contraception contrary to medical guidelines.²²

Women could also be provided with guidance to determine whether they can be reasonably certain they are not currently pregnant.²⁰ Some women may fall outside of these criteria and it is possible that they could start hormonal contraception with a clinically unrecognized pregnancy.

Since these methods can alter women’s bleeding patterns and their overall suspicion for pregnancy, women who are not completely certain they aren’t currently pregnant could quick start their method and take a home pregnancy test in 2 weeks.²⁰

Additional guidance for backup contraception could be provided. Fortunately, if a woman does take hormonal contraception while pregnant, the exogenous hormones should not harm a developing pregnancy in the event she desires pregnancy continuation.

Other office-visit undertakings

Contraceptive visits are often a time to review other aspects of a woman’s health. The Centers for Disease Control and Prevention’s 2016 U.S. Selected Practice Recommendations for Contraceptive Use (SPR) advises against withholding contraception for breast exams, pelvic exams, sexually transmitted infection testing, or cervical cancer screening.²⁰

Though the SPR does recommend blood pressure measurement prior to starting estrogen-containing methods, women could use assessment from a recent health care visit or perform a self-measurement at a pharmacy or at home.²⁰

Cost

Decreased cost could be an additional benefit of OTC hormonal contraception since women would avoid office visit fees. The Affordable Care Act (2010) provided a federal contraceptive coverage guarantee that required private health plans to cover all 18 methods of FDA-approved contraception without co-pay or deductible.²³

General insurance coverage was also extended to dependents under the age of 26, spanning a large number of adolescent and adult contraceptive users.²³ Some states expanded contraceptive coverage, with 20 states and Washington, D.C., requiring insurers to cover dispensation of an extended supply of contraception at one time.²³

Given recent attempts by the current federal administration to weaken the contraceptive coverage guarantee, women may face cost concerns about whether their method is obtained with a prescription, from a pharmacist, or OTC.

For policymakers, transitioning hormonal contraception to OTC status should not free it from insurance coverage. The place that a woman accesses her method should not be linked to the amount an insurance company will cover for the same medication.

Now is the time

As we navigate the global COVID-19 pandemic and anticipate our new normal, we need to ensure access to contraception. Reproductive planning is complex at baseline and a person’s interest in becoming pregnant may alter depending on their own personal experience during this time. From financial to medical concerns and everything in between, risk-benefit calculations regarding pregnancy will change.

Now is the time for drug companies to pursue OTC status for hormonal contraception. We need to empower people like my patient in their execution of their reproductive goals. With all the uncertainty in the world, access to hormonal contraception should be ensured.

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References

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