Methotrexate Prescribing in the Post-Roe Setting 

Johnson City, Tenn – Aug. 2 : Becky Hubbard holds her last pills of Methotrexate on Tuesday, Aug. 2, 2022 in Johnson City, Tenn. Hubbard has rheumatoid arthritis and for years has treated it using Methotrexate, a drug that is sometimes used to terminate pregnancies. After the Supreme Court overturned Roe v. Wade, Hubbards doctor told her that if she wanted to continue to use the drug, she needed to either go on birth control or get sterilized. (Photo by Earl Neikirk for The Washington Post via Getty Images)
AMA president Jack Resneck, Jr., MD, and David M. Pariser, MD, FAAD, a dermatologist in private practice, tell us their thoughts and experiences on the challenges patients face in accessing methotrexate.

In June 2022, the United States Supreme Court’s ruling on Dobbs v Jackson Women’s Health Organization reversed the Roe v Wade decision that had affirmed the constitutional right to abortion for nearly 50 years. Numerous professional medical societies promptly issued statements expressing their opposition to the decision. Among other points of contention, the American Medical Association (AMA), the American College of Obstetricians and Gynecologists, and other groups emphasized that the ruling would endanger lives and interfere with the physician-patient relationship.1,2

These scenarios began to materialize almost immediately, with doctors reporting they had been advised by their institutions’ attorneys to withhold medically necessary care for pregnant patients until the risk to the patient’s life became more apparent.3 In addition, patients in various states suddenly faced restrictions on access to methotrexate, which is used in the treatment of various types of cancer as well as severe, treatment-resistant cases of autoimmune diseases such as rheumatoid arthritis, lupus, and psoriasis.4,5

Limited Access

Methotrexate has also been used off-label in the treatment of miscarriage and ectopic pregnancy, and it can be combined with misoprostol to induce abortion in early pregnancy.4,6 Because methotrexate can interfere with pregnancy, restricted access to the drug has become an issue for those who rely on it to manage their chronic disorders.

Now, 2 large US pharmacy chains have “instructed their pharmacists to confirm methotrexate will not be used to terminate a pregnancy before dispensing it to people in states that ban abortion in many circumstances,” according to Reuters.4

Since the reversal of Roe v Wade, patients are reporting unprecedented challenges in accessing methotrexate. Even those patients in states without extreme abortion laws have been experiencing abrupt disruptions to their drug regimens: in interviews with CNN, a Maryland woman with Crohn’s disease said her health insurance plan informed her they would no longer cover her methotrexate prescription, and a Virginia woman with lupus said her rheumatologist told her she would need to be weaned off methotrexate and switched to another drug.7 Because of the Dobbs decision, her doctor’s office said “it was pausing all prescriptions and refills of methotrexate.”

AMA president Jack Resneck, Jr., MD, a dermatologist at the University of California, San Francisco, told us that requiring patients on methotrexate to switch treatment regimens can result in delays in care and possibly worse outcomes. As he testified8 before Congress: “The AMA is hearing that some pharmacies are refusing to stock the drug and some pharmacists are refusing to dispense it. In addition, it has been reported that some physicians are refusing to prescribe methotrexate and other medications to patients who may become pregnant given concerns about criminal prosecution despite these patients not being pregnant.”

David M. Pariser, MD, FAAD, a dermatologist in private practice in Norfolk, Virginia, said, “I have not personally had any problems prescribing methotrexate, and I also checked with a pharmacist in the building where I practice, who reports no such issues thus far.” However, he points out that Virginia is not a state with anti-abortion laws or “trigger” laws on the books that would have severely limited or ended abortion access upon the Roe v Wade reversal. “I have heard about colleagues in other states having issues prescribing methotrexate, but how much of it is really going on, I just don’t know,” he said in an interview with us.

Dr Pariser offered a hypothetical scenario in which his patients could potentially be affected in the event that access to methotrexate is limited. Certain health care plans mandate the use of methotrexate before they will allow the use of safer and more effective drugs, he noted. “Medicaid of Virginia requires 6 months of methotrexate failure before they will cover biologic therapies. If a pharmacist won’t fill it, then what does the patient do?” Dr Pariser also wondered if methotrexate prescriptions for men would be filled without interference, given that pharmacists might be concerned that the drug could ultimately be given to a man’s wife, girlfriend, or daughter.

On that note, the US Department of Health and Human Services recently issued a warning to pharmacists that refusal to fill methotrexate and other drugs due to their potential to terminate pregnancy may constitute sex-based discrimination.9 “Pharmacists who refuse to fill methotrexate prescriptions are engaging in discrimination, but I don’t know if it’s sex-based because we would need to know whether they will fill these prescriptions for men” in order to make that determination, said Dr Pariser.

Action Steps

Dr Pariser recommended that dermatologists become familiar with the laws in the states where they practice and what they could possibly be held accountable for. “For extra assurance, if you’re writing a methotrexate prescription, write clearly on the prescription what it’s intended for and make sure it’s on the label of the bottle once filled.”

In terms of broader measures to address this issue, Dr Pariser said the ultimate fix is legislative, although that may not be possible in states with broad-reaching anti-abortion laws. “The most effective lobbying is really not from doctors, it’s from patients, so some patients who weren’t given methotrexate and almost died because of it need to be trotted out in front of the legislature,” he suggested. He advised that patients identify the chairman of the committee who would handle this issue and reach out to that individual.

In addition, the AMA supports “legislation that requires individual pharmacists or pharmacy chains to fill legally valid prescriptions or to provide immediate referral to an appropriate and accessible alternative dispensing pharmacy without interference,” Dr Resneck said. In the latter instance, the pharmacist or pharmacy chain should return the prescription to the patient and notify the prescribing physician that they have referred the patient to another pharmacy.

“In the absence of all other remedies, the AMA supports working with state medical societies to adopt state legislation that will allow physicians to dispense medication to their own patients when there is no pharmacist within a 30-mile radius who is able and willing to dispense that medication,” he stated. “The AMA also supports the concept of advance prescription for emergency contraception for all women in order to ensure availability of emergency contraception in a timely manner.”

References

  1. Resneck J Jr. Dobbs ruling is an assault on reproductive health, safe medical practice. American Medical Association. June 24, 2022. Accessed August 16, 2022
  2. The Cancer Letter. Oncology and healthcare groups respond to the end of Roe v. Wade. July 1, 2022.  Accessed August 16, 2022
  3. Muoio D. Post-Roe care is ‘complete and utter chaos,’ docs tell Congress. Fierce Healthcare. July 20, 2022. Accessed August 16, 2022.
  4. Horowitch R. State abortion bans prevent women from getting essential medication. Reuters. July 14, 2022. Accessed August 16, 2022.
  5. Koźmiński P, Halik PK, Chesori R, Gniazdowska E. Overview of dual-acting drug methotrexate in different neurological diseases, autoimmune pathologies and cancers. Int J Mol Sci. 2020;21(10):3483. doi:10.3390/ijms21103483
  6. Creinin MD. Medical abortion with methotrexate 75 mg intramuscularly and vaginal misoprostol. Contraception. 1997;56(6):367-3371. doi:10.1016/s0010-7824(97)00173-x
  7. Christensen J. Women with chronic conditions struggle to find medications after abortion laws limit access. CNN. July 22, 2022. Accessed August 16, 2022.
  8. Resneck J Jr. Roe reversal: The impacts of taking away the constitutional right to an abortion. Statement of the American Medical Association to the Subcommittee on Oversight and Investigations Committee on Energy and Commerce US House of Representatives. July 19, 2022. Accessed August 16, 2022.
  9. US Department of Health and Human Services. Guidance to nation’s retail pharmacies: Obligations under federal civil rights laws to ensure access to comprehensive reproductive health care services. Accessed August 16, 2022

This article originally appeared on Dermatology Advisor