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Abortion Drug Bans Make Pharmacies Wary of Common Arthritis Pill

July 14, 2022, 9:50 AM

Confusion over prescribing a common arthritis drug post-Roe is prompting demands for state guidance as pharmacies and providers grapple with the fallout of the US Supreme Court’s abortion ruling.

Patient reports of delays or roadblocks in accessing methotrexate have risen on social media since the high court’s ruling triggered abortion bans in 22 states. Prescribers and advocacy groups say state medical and pharmacy boards need to clarify best practices for health professionals who fear legal repercussions for actions that go beyond abortion.

“What we’re seeing is an overreaction to the unknown of some of the laws or regulations that might restrict access,” said Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists.

Methotrexate is FDA-approved to treat joint inflammation and improve mobility among patients with inflammatory arthritis, lupus, psoriasis, and other conditions. But some states consider it an abortion-inducing drug, both because of its risks of miscarriage in pregnant individuals and use in gynecology to treat ectopic pregnancies.

Roughly 90% of rheumatoid arthritis patients use methotrexate at some point in their treatment, according to the Arthritis Foundation.

“There’s a real need out there for anyone from the governors to legislators to boards of medicine and boards of pharmacy to be as clear as possible in issuing guidance or revising laws to make sure that access to these medications is not affected,” Ganio said.

Guidance released Wednesday by the Department of Health and Human Services says pharmacists who refuse to fill methotrexate for inflammatory arthritis patients may be violating federal anti-sex discrimination laws. Individual state laws may vary—supporting the need for state-specific guides, patient advocates say.

The Kentucky Board of Pharmacy has already issued recommendations to pharmacists and other health professionals, but trade groups say delayed access is certain to continue without additional efforts to reduce legal confusion.

CVS Health said in a statement that before filling a prescription for methotrexate in some states, “we instruct our pharmacists to validate that the intended indication is not to terminate a pregnancy.”

The company said it encourages providers “to include their diagnosis on the prescriptions they write to help ensure patients have quick and easy access to medications.”

‘Confusion and Caution’

Jennifer Crow, a 48-year-old writer in Tellico Plains, Tenn., got an automated call from her CVS pharmacy in early July that her prescription wouldn’t be refilled. Crow, who has inflammatory arthritis and a neuromuscular disease called myasthenia gravis, said in an interview that methotrexate has allowed her to resume simple, yet previously painful tasks like putting on her pants and rolling over in bed.

“I was late on my meds, so it was extra pain and I had lower energy,” said Crow, who was eventually able to get a new prescription from her doctor. “I didn’t do a thing for the holiday weekend except trying to manage my new pain.”

Methotrexate is “one of our gold standard, go-to drugs for the control of inflammatory arthritis in our patients,” according to Anisha Dua, a rheumatology professor at the Northwestern University Feinberg School of Medicine.

Delays in getting it, even if temporary, can lead an arthritis patient to have a “disease flare,” Dua said. “They will end up with more significant joint pain, stiffness in the morning, problems functioning.”

Laws in states like Texas that restrict abortion care and list methotrexate as an abortion-inducing drug are prompting “confusion and caution in dispensing the medication,” said Steven Schultz, the Arthritis Foundation’s director of state legislative affairs.

Methotrexate is only used in gynecology for ectopic pregnancies—in which the fetus forms outside the uterus and isn’t viable. The Texas law includes mifepristone, misoprostol, and methotrexate under its description of an “abortion-inducing drug,” but also states that the restrictions don’t apply to drugs that may be known to cause an abortion but aren’t prescribed for that use.

Patient advocates say that trigger laws banning abortion in some states may also have a chilling effect on medical care if it’s unclear whether health providers are protected to dispense treatment that may lead to pregnancy loss, but isn’t prescribed for that purpose. In Tennessee, for example, a law is set to go into effect making abortion illegal after a fetal heartbeat is detected except in cases of “medical emergencies.”

“Pharmacists are not necessarily attorneys with knowledge of the various state laws,” so they “can be confusing,” Alisa Vidulich, policy director for the Arthritis Foundation, said.

Emergency Response

The American College of Rheumatology, which has more than 7,000 member physicians and health professionals, said it’s assembled a task force of medical and policy experts “to determine the best course of action for ensuring our patients keep access to treatments they need,” according to an emailed statement.

The Arthritis Foundation said it has set up a hotline for people to report difficulties getting methotrexate. It also has a toll-free helpline staffed by a licensed clinical social worker and trained staff to provide “one-on-one support” in helping patients get needed medications, according to the organization’s website.

Vidulich said the foundation is still “in the beginning stages of trying to figure out and identify how widespread this issue is by state, by patient demographics, and learning who exactly has been impacted.” She noted, though, that the situation is only likely to get worse in the coming weeks and months.

“Patients fill their prescriptions at varying times,” she said. “A lot of patients may have a full prescription and may not need to come in right now at the moment.”

Meanwhile, many pharmacists and prescribers are “waiting for their professional medical association to put out recommendations and clarify that a medical intervention is not an abortion if it is prescribed to treat other conditions,” Vidulich said.

The Arthritis Foundation is reaching out to state and federal governments to educate them on what they’re hearing from prescribers and patients. Dua said she’s working to educate patients and fellow prescribers on the access issues, and encouraging them to share their experiences with medical associations so they can issue guidance.

“Education is always the strongest tool,” Dua said. “Hopefully between education and advocacy we’re able to make sure that patients still get the medications that they need.”

The Kentucky Board of Pharmacy July 1 sent an email, shared with Bloomberg Law, to all licensed pharmacists and pharmacy interns in the state saying that “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.”

But Ganio said Kentucky’s approach “isn’t really ideal” because providers should automatically indicate on prescriptions the intended use for the drug. “The diagnosis and the indication for the prescription should be known to the pharmacist so that they can do that full check to make sure it’s medically appropriate for the patient,” he said.

In Kentucky, a judge has temporarily blocked from going into effect a 2019-passed law triggered by the Supreme Court decision that would allow doctors who provide abortions to be charged with a felony.

Other Drugs at Risk

Health professionals say the impacts of Dobbs extend beyond methotrexate.

Prescribing and dispensing guidance should be worked out across states “before we get to the point of denying folks really common medications,” Sarah Horvath, an assistant professor of obstetrics and gynecology at Penn State University, said.

She noted that medications like antibiotics, or over-the-counter drugs like ibuprofen, also have risks when used during pregnancy.

Dua said she has the same concerns, and that “if we start limiting any medication that could potentially lead to a fetal abortion or to fetal loss, that becomes a very large list of medications.”

State policymakers should revisit abortion bans and laws restricting drugs like methotrexate to make changes and limit medication access problems in the long term, Ganio said. “It’s incumbent on the policymaking—whether individuals or a policymaking body—to just be absolutely clear in what is affected and what isn’t,” by the Dobbs decision, he added.

Continued uncertainty also has the danger of leading prescribers to turn to treatments that have less known risks or side effects, but that may not be as effective at treating inflammatory conditions, Dua said.

“It’s going to force us to use other medications or go down different pathways to try to get their disease under control,” she said.

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Cheryl Saenz at csaenz@bloombergindustry.com