Isotretinoin and methotrexate regarding prescribing after Roe v. wade

More than 3 months after the US Supreme Court’s Dobbs decision overturned Roe v. Wade and revoked the constitutional right to abortion, dermatologists who prescribe isotretinoin, a teratogenic drug used to treat severe nodular acne, say they are even more worried than in the past about their patients and the risk of accidental pregnancies . Some reinforced their already strict instructions and lengthy conversations about avoiding pregnancy during treatment.

The main fear is that a patient who takes contraceptive precautions, in accordance with the isotretinoin risk management program, iPLEDGE, but who still becomes pregnant while on isotretinoin, may discover the pregnancy too late to undergo an abortion in their own state and not be able to travel to another state – or the patient may live in a state where abortions are completely prohibited and cannot travel to another state.

Isotretinoin is marketed under the names Absorica, Absorica LD, Claravis, Amnreason, Myorisan and Zenatane; its former brand name was Accutane.

As of October 7, a total of 14 states have banned most abortions, while four others have banned at 6, 15, 18 or 20 weeks. Attempts to restrict abortion in several other states are underway.

“At this time, we don’t know of any specific effect of the Dobbs decision on isotretinoin prescribing, but with access to abortion banned in many states, we anticipate this could be a very real problem for people. who accidentally get pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco and chair of the American Academy of Dermatology Association’s iPLEDGE task force.

The iPLEDGE REMS (Risk Assessment and Mitigation Strategy) is the FDA required safety program that is in place to manage the risk of teratogenicity of isotretinoin and minimize exposure to the fetus. The task force meets with the FDA and isotretinoin manufacturers to ensure the safety and proper functioning of the program. The iPLEDGE task force has yet to issue specific statements on the implications of the Dobbs decision on isotretinoin prescribing.

But work on the matter is ongoing by the American Academy of Dermatology. In a statement released last month, Mark D. Kaufmann, MD, president of the American Academy of Dermatology, said the academy “continues to work with its Patient Advisory Task Force for State Regulations regarding reproductive health to help dermatologists better navigate state laws on how care should be implemented for patients who are or may become pregnant and who have been exposed to teratogenic drugs.

The task force, in conjunction with the Academy, is “developing resources to help members better support patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given as to when these resources might be available.

Prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis and other skin diseases, are also of concern. Shortly after the announcement of the Dobbs decision on June 24, pharmacies began requiring pharmacists in abortion-banning states to verify that a prescription for methotrexate was not intended for an abortion, because methotrexate is used in combination with misoprostol to terminate an early pregnancy.

The action was taken, spokespersons for several major pharmacies said, to comply with state laws. “Pharmacists are caught in the crossfire on this issue,” said CVS spokesperson Kara Page. Laws in some states, she told Medscape, “restrict the dispensing of drugs for the purpose of inducing an abortion. These laws, some of which provide criminal penalties, have required us to require pharmacists in these states to ‘they validate that the intended indication is not to terminate a pregnancy before being able to fill a prescription for methotrexate.

“New laws in various states require additional steps to dispense certain prescriptions and apply to all pharmacies, including Walgreens,” Walgreens spokesperson Fraser Engerman told Medscape. “In these states, our pharmacists work closely with prescribers as needed, to fill legal and clinically appropriate prescriptions. We provide ongoing education and information to help our pharmacists understand the latest requirements in their field, and with these supporters, they are expected to be empowered to fill these orders.

The iPLEDGE program has many requirements before a patient can start treatment with isotretinoin. Patients capable of becoming pregnant must agree to use two effective forms of contraception during the entire treatment period, which usually lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to abstinence total during this period.

Point of view: a Georgian dermatologist

Howa Yeung, MD, MSc, an assistant professor of dermatology at Emory University in Atlanta who regularly sees patients, practices in Georgia, where abortion is now banned at around 6 weeks gestation. Yeung worries that some dermatologists in Georgia and elsewhere won’t even want to risk prescribing isotretinoin, though the results in treating resistant acne are well documented.

It’s not his only concern. “Some may not want to prescribe it to a patient who claims to be abstinent and ask them instead to fill out two forms [of contraception]“Or some women who are not sexually active with someone who can get them pregnant may also be asked to take contraception, he said. Abstinence is an alternative option in iPLEDGE.

In the past, he said, long before the Dobbs decision, some doctors argued that iPLEDGE should not include abstinence as an option. This 2020 report was challenged by others who pointed out that removing the abstinence option would raise ethical issues and could disproportionately affect minorities and others.

Before the Dobbs decision, Yeung noted, dermatologists prescribing isotretinoin focused on preventing pregnancy, but knew that if pregnancy happened accidentally, abortion was available as an option. “The reality after the decision is that it may or may not be available to all of our patients.”

Of the 14 states banning most abortions, 10 are clustered in the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.

POV: An Arizona dermatologist

Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, it didn’t change her practice much when prescribing isotretinoin, she told Medscape., for when selecting suitable candidates for the drug, she is strict about requiring contraception and only very rarely accepts a patient’s reliance on abstinence.

What if a patient capable of getting pregnant only had sex with another patient capable of getting pregnant? Kranc said she would always need contraception unless it was impossible for pregnancy to occur.

Among the many scenarios a dermatologist might have to consider is a cisgender lesbian woman who has, or has had, only sexual activity with another cisgender woman.

POV: Connecticut dermatologist

The concern isn’t just for isotretinoin, but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice president of dermatology and professor of dermatology, pathology and pediatrics at the University of Connecticut. She often prescribes methotrexate, which is also teratogenic.

Her advice to her colleagues: “Whether or not you believe in abortion doesn’t matter; it’s something you discuss with your patients. She, too, is worried that doctors in states that ban abortion will stop prescribing these drugs, “and that’s very sad.”

For those practicing in states that restrict or prohibit abortions, she said, “They need to have an even longer discussion with their patients about the seriousness of the situation.” These physicians should discuss not only two or three types of contraception, she insists, but also discuss with the patient the potential need to travel, if pregnancy occurs and abortion is the chosen option.

Although new biologics are an option for psoriasis, they are expensive. And, she says, many insurers require a step-by-step treatment approach and “want you to start with cheaper drugs,” like methotrexate. As a result, “in some states you won’t have access to targeted therapies unless a patient fails something like methotrexate.”

She is particularly worried about low-income women who may not have the means to travel to have an abortion.

Need for EC education

In a recent survey of 57 pediatric dermatologists prescribing isotretinoin, only one-third said they were confident in their understanding of emergency contraception.

The study authors noted that the most common reasons for pregnancies during isotretinoin treatment reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.

Yeung, Kranc, Grant-Kels, and Frieden report no relevant financial relationships.

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