What Women Can Do if RA Medication Methotrexate Is Denied

What Women Can Do if RA Medication Methotrexate Is Denied

“Are you pregnant or do you plan on being pregnant?” asked the pharmacist.

Novelist Annie Noblin, 40, of West Plains, Missouri, had come in to pick up her prescription for methotrexate for her rheumatoid arthritis (RA). There had never been a problem before. But since Roe v. Wade had been overturned on June 24, 2022, things had changed. Missouri is in a trigger state, where strict anti-abortion laws were “triggered.”

Sometimes methotrexate is used off-label to end ectopic pregnancies, and use while pregnant can cause miscarriages or birth defects. Women with RA in states with restrictive abortion laws are now finding themselves in the crosshairs.

Noblin had gotten a text earlier in the day that her prescription was being held up. After hearing nothing for hours, she finally went into the pharmacy where she was told that her rheumatologist had to confirm that this was not going to be used for an abortion. And she had to reveal if she was pregnant or planning to be.

“I was livid,” she says. “It felt so invasive. Why are my reproductive plans anyone’s business? The pharmacist said she couldn’t give me the medication until I answered. I was forced then to release my private personal information.

“And now I am going to have to do this every time I try to fill a prescription. Because I can't stand on principle; I have to have this medicine,” she says, adding, “And what if I do become pregnant? Am I then liable for what happens?”

When asked to comment on this issue, Laura Echevarria, communications director and press secretary of the National Right to Life Committee, responded via email: “This is absurd. No law passed or proposed by the pro-life movement prohibits doctors from prescribing methotrexate for arthritis. … There are no pro-life laws designed to prevent the drugs from being administered for treatment for arthritis.”

And yet, Steven Newmark, director of policy and general counsel for the Global Health Living Foundation, confirms that access to methotrexate is becoming a problem in our post-Roe world. “We have heard from women in certain states that had trigger laws in the wake of theDobbsdecision, that they were being denied access to their FDA [U.S. Food and Drug Administration]–approved drug for their chronic condition. Additional barriers have been put in place in certain instances or more questions were asked. In certain instances we've heard of folks who have just been denied outright.”

Some states are trying to clear up the matter. Kentucky’s Board of Pharmacy published the following emergency rule:

“Any prescription or medical order for a drug that is known to possibly cause an abortion shall be presumed by a pharmacy to be for indications other than for the termination of a pregnancy. A pharmacy dispensing such prescription or medical order shall not be required to verify that the prescription or medical order does not violate any provision of this chapter or KRS Chapter 216B.”

But when contacted, Amy Thibault, lead director of external communications for CVS Pharmacy, responded via email, “Laws in certain states restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate or misoprostol.”

The American Pharmacists Association (APHA) sounded an alarm in its July statement, saying “Today, in response to the U.S. Supreme Court recent decision in Dobbs v. Jackson Women’s Health Organization, the U.S. Department of Health and Human Services’ [HHS] Office for Civil Rights (OCR) released guidance [PDF] for pharmacies that sets forth their obligations under federal civil rights laws, conflicting with some state laws, and raises concerns for our nation's pharmacies and pharmacists.”

What’s more, says the APHA, “The guidance also takes away a pharmacists’ professional judgment to make ‘determinations regarding the suitability of a prescribed medication for a patient; or advising patients about medications and how to take them.’ The implications of the guidance have the potential to cause widespread unintended consequences beyond reproductive healthcare services.”

In the meantime, E. Michael Murphy, PharmD, advisor for state government affairs at the APHA says, “We have urged state and federal policymakers to take action to ensure patients maintain access to FDA-regulated medications and evidence-based patient care services. It is a complicated question because the laws and regulations in each state are different. We encourage our members to refer to state laws and regulations. ... And we encourage policymakers to provide explicit guidance to healthcare professionals in how to navigate these confusing regulations.”

“Physicians have been placed in an impossible situation, trying to meet their ethical duties to place patients’ health and well-being first, said American Medical Association (AMA) President Jack Resneck Jr., MD, when he provided testimony (PDF) to the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations, on July 19, 2022. “We have only begun to assess the full impact of the Dobbs decision,” he said, adding, “At this point, we have more questions than answers.”

In the meantime, Thibault says CVS encourages providers to include their diagnosis on the prescriptions they write so pharmacists know immediately what the medication is intended for.

Section 1557 of the Patient Protection and Affordable Care Act is federal law that broadly prohibits sex discrimination in federally funded health programs and activities. The HHS Office of Civil Rights is charged with enforcing this. “That guidance says that generally speaking, pharmacies cannot refuse to dispense medication related to reproductive health, including, but not limited to misoprostol and methotrexate, explains Michelle Banker, director of reproductive rights and health litigation at the National Women’s Law Center.

The reason, she continues, “is that refusing them may constitute discrimination on the basis of sex, which includes discrimination on the basis of pregnancy. It also would include discrimination on the basis of disability, including certain autoimmune diseases that methotrexate is used to treat.”

Banker adds that one other nuance is that it is possible that in certain limited circumstances, an individual's pharmacist or a pharmacy employee may invoke certain federal laws that permit this sort of refusal on religious grounds but those refusal statutes don't extend to the pharmacy itself. If a person at the pharmacy refuses to fulfill a prescription, then someone else at the pharmacy must do so.

Invoke Section 1557. Bring a copy of "Guidance to Nation’s Retail Pharmacies: Obligations under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services." On page 3, it lists two examples of how denying methotrexate may constitute sex or disability discrimination. Noblin, for example, could use this to refuse to give invasive, personal information. If you are up to it, you can also file a complaint with the HHS Office for Civil Rights or bring a lawsuit against the discriminating party.

The Arthritis Foundation recommends the following:

Global Healthy Living Foundation and CreakyJoints The Global Healthy Living Foundation and CreakyJoints, advocacy organizations, are encouraging people to contact their elected officials to let them know the importance of this vital medication. To share your story with CreakyJoints, send a tweet to @zoerothblatt‬‬‬‬‬.

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