OTC birth control debut in 2024 ‘empowers’ patients with rheumatic diseases

Issue: January 2024

ByRob Volansky

Fact checked byShenaz Bagha

Come the new year, a “mini” pill could have a massive impact in rheumatology care.

On July 13, the FDA approved Opill (norgestrel, HRA Pharma) as the first ever daily contraceptive pill available for over-the-counter use in the United States. A progestin-only form of oral contraception — meaning it does not contain estrogen — Opill is expected to appear on store shelves in early 2024.

In the aftermath of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, that a woman does not have a Constitutional right to an abortion, this development promises wide-ranging effects for reproductive planning and health care throughout the country. That includes patients with rheumatic diseases that demonstrate well-known associations with adverse pregnancy outcomes, such as lupus, vasculitis and systemic sclerosis, or who use teratogenic medications.

However, many rheumatologists do not feel comfortable discussing reproductive issues with their patients. Understanding the landscape of available birth control methods, as well as disease-related parameters that can impact reproductive health, is critical to providing care tailored to each individual patient’s needs and timelines regarding family planning.

Healio sat down with Catherine A. Sims, MD, a clinical associate in the department of medicine, rheumatology and immunology at Duke University, to discuss the present and future of reproductive health in rheumatology — post-Dobbs and on the eve of OTC-available birth control.

Healio: In general terms, how has the tightening of abortion access impacted rheumatology patients?

Sims: Rheumatology is a discipline where the majority of our patients are anatomically female given the predominance of autoimmune disease in this population. Autoimmune disease impacts all aspects of reproductive health care, including contraception, pregnancy, breastfeeding and menopause. This demonstrates the importance of rheumatologists taking an active role in reproductive health care discussions.

Subspecialists can provide tailored management recommendations while taking into consideration the patient’s autoimmune disease. The option of elective abortions is certainly an important aspect of medical care in our patient population, as unplanned pregnancies can result in autoimmune disease flares, maternal morbidity and mortality, and poor pregnancy outcomes, including preeclampsia, pregnancy loss and preterm delivery.

We have cases of unplanned pregnancies with accidental exposures to teratogenic medications, which are necessary for autoimmune disease control, that can cause devastating fetal abnormalities resulting in emotional, psychological and physical stress on the patient. This stress can be prolonged without access to abortion services. The decision to move forward with an elective abortion often comes after extensive conversations with multiple subspecialists evaluating autoimmune disease activity, end organ damage, and the pregnancy compatibility of required medications to control disease activity.

This is a personal decision made by the patient in collaboration with their medical team to preserve maternal health and avoid a high-risk pregnancy.

Healio: Now that rheumatology patients, depending on where they live, may no longer have abortion access, discussions about birth control are extremely important. How are you talking to your patients about it?

Sims: Contraception is critical for patients with autoimmune disease. Rheumatologists have the opportunity to ask patients about family planning at each of their clinic visits, because our management plans should be in alignment with any personal goals the patient may express. For example, if an anatomically female patient voices an interest in pregnancy, we would want to avoid teratogenic medications and ensure we prepare the patient for a successful pregnancy.

To optimize chances for a successful pregnancy in a patient with autoimmune disease, the pregnancy should be planned during well-controlled disease on pregnancy-compatible medications. The most powerful tool we have to avoid unplanned pregnancies is effective contraception.

In patients who are sexually active, but not interested in pregnancy in the next 12 months, establishing a highly effective birth control plan with the patient during a clinic visit is of utmost importance. This may be intimidating to many rheumatologists, so we recommend using handouts to facilitate these discussions.

The American College of Rheumatology has a “Reproductive Health Initiative” website, which contains several tools. Additional resources include the HOPSTEP handout, Vasculitis Pregnancy Registry and ReproRheum.

Healio: Is it possible that patients could be uncomfortable with their rheumatologist having interest in their reproductive health?

Sims: It may not be intuitive to patients why their rheumatologist is interested in their pregnancy plans and reproductive goals. Rheumatologists can explain the concerns and risks associated with unplanned pregnancies, including teratogenic exposure, disease flare, pregnancy complications, etc., and why contraception is highly recommended. There are many options for contraception, and it should be a collaborative discussion with the patient.

Any form of contraception is better than no contraception, but not all contraception is created equal. The resources I mentioned graphically display the effectiveness of each contraceptive and explain that the barrier methods, such as condoms, are much less effective than long-acting reversible contraceptives, including intrauterine devices and subdermal implants.

Healio: How does the availability of OTC birth control change the equation for reproductive health in rheumatology?

Sims: OTC birth control is an exciting development in reproductive health. Often times we will observe patients who want to start birth control, but their medical providers are uncomfortable prescribing contraceptives given the rarity of their condition. Understandably, primary care providers and gynecologists do not manage rare autoimmune diseases on a regular basis, so they seek the input of a rheumatologist who is more familiar with disease characteristics.

However, mixed-methods studies have demonstrated rheumatologists are uncomfortable with reproductive health and often times defer back to the patient’s primary care provider or gynecologist. This puts patients in a difficult position, and they can be left without a contraceptive plan, making them at high risk for an unplanned pregnancy. The OTC contraceptive option empowers patients to make decisions about their reproductive health if they do not have access to medical providers or cannot find a provider who is comfortable prescribing them a contraceptive.

Healio: What exactly is now available to patients?

Sims: The FDA in July approved Opill for OTC use. It is important to recognize that this form of contraceptive does not contain estrogen, only progestin. In patients with rheumatic disease, the presence of estrogen in a contraceptive can be a contraindication based on disease type — particularly systemic lupus erythematosus —disease activity level, history of thrombosis, and presence of specific autoantibodies.

Since Opill does not contain estrogen, it is safe to use in all patients with rheumatic disease. In fact, the 2020 ACR Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases strongly recommends the use of progestin-only pills as contraceptives.

It is important to recognize that progestin-only pills are not the most effective form of birth control, compared to IUDs and subdermal implants, and some patients can experience breakthrough bleeding. To reach full efficacy, progestin-only pills should be taken at the same time every day.

Healio: What about other forms of birth control, and what is safe for which patients?

Sims: When I discuss contraceptive options during patient visits, I like to use a visual comparing the effectiveness of different types of birth control in three tiers. The most effective, with fewer than 1% experiencing an unplanned pregnancy, is an IUD, which lasts 3 to 10 years. In addition, subdermal implants last 3 years, while tubal ligation and vasectomy are typically permanent.

In the moderately effective category, where 6% to 9% experience an unplanned pregnancy, there are the “minipill” — or progestin-only pills — and pills with estrogen. Depo-Provera (medroxyprogesterone acetate, Pfizer) is an injection every 3 months, while the vaginal ring and patch are replaced monthly.

Those in the least effective category may result in unplanned pregnancies 10% to 25% of the time. These approaches include barrier methods like condoms, diaphragms, sponges and cervical caps, along with spermicide, natural family planning like ovulation tracking, and the withdrawal method.

Healio: What factors should go into selecting one of these approaches?

Sims: When choosing the best birth control option, it is important the patient is comfortable with the plan, and that it aligns with their reproductive goals. For rheumatologists, assessing disease type, disease activity level, presence of autoantibodies, and comorbidities like osteoporosis, history of thrombosis and others will ensure they make the safest option for their patient.

In general, the ACR recommends avoiding estrogen patches in patients with SLE given the high concentration of estrogen present, as well as avoiding estrogen containing contraceptives in patients with a history of thrombosis, avoiding Depo-Medrol (methylprednisolone acetate, Pfizer) injections in patients with osteoporosis, and always using two forms of contraception for a patient taking a mycophenolate containing immunosuppressives.

Healio: What can a rheumatologist who wants to improve reproductive rights for their patients do to improve the current situation?

Sims: The most impactful thing a rheumatologist can do is start talking to their patients about reproductive health during clinic visits on a regular basis. This signals to the patient that you are interested in this aspect of their medical care, and you are willing to engage and create a plan that aligns with their personal goals.

Prior research from Sammaritano and colleagues in Arthritis & Rheumatology has shown that our patients want us involved in these conversations because we are “the doctors who know them and their medications best.” These conversations will give patients the opportunity to discuss contraceptive options and initiate the best and safest option for them.

Healio: What can rheumatologists do outside of the clinic to improve reproductive rights?

Sims: Providers can also join their state and local medical boards to engage with politicians advocating for the reproductive rights of their patients. Our patient population suffers from chronic and complex diseases and unplanned pregnancies can be life threatening.

Pregnancy is not a benign medical condition and given the possibility of organ and/or life-threatening disease, access to all medical procedures is imperative to the overall health and wellbeing of patients.