Washington, DC—Pharmacists are increasingly finding themselves in the middle of the fallout from the U.S. Supreme Court's Dobbs v. Jackson Women's Health Organization decision.
The American Pharmacists Association (APhA), American Society of Health-System Pharmacists (ASHP), and National Community Pharmacists Association (NCPA) recently joined the American Medical Association (AMA) in expressing concern about state laws that limit patients' access to medically necessary medications and impede physicians and pharmacists from using their professional judgment.
The Supreme Court decision increased the demand for abortions through medications, and some states responded by adding restrictions. The organizations point out, "Following the U.S. Supreme Court...decision, physicians, pharmacists, and other healthcare professionals face a confusing legal landscape due to state laws' lack of clarity, confusing language, and unknown implementation by regulatory and enforcement bodies. This includes many questions about how broadly state laws will be interpreted and the impact of these actions on physicians' and pharmacists' ability to serve the needs of their patients."
The medical and pharmacy associations insist that physicians and pharmacists need straightforward guidance from state boards of medicine and pharmacy, agencies, and policymakers on prescribing and dispensing medically necessary medications that are affected by the legal and regulatory changes. "Without such guidance, we are deeply concerned that our patients will lose access to care and suffer irreparable harm," the groups add in a statement.
"In the wake of the Dobbs decision, over half of U.S. states have severely restricted or are expected to soon restrict access to abortion services, including medications that induce abortions," the statement notes. "In many states, these laws prohibit prescribing and dispensing an 'abortion-inducing drug,' or contain other comparable terms. This language is vague, and it is unclear whether it prohibits certain medications only when prescribed to induce abortion or whether a medication is prohibited entirely if it has the potential to induce abortion regardless of the condition for which it was prescribed."
A key example is methotrexate, which can be used off-label for the termination of intrauterine pregnancy and is also approved and used off-label for many other indications, such as cancer and ectopic pregnancy. The drug also is commonly prescribed for the first-line treatment of inflammatory diseases, such as arthritis.
In addition, the groups write, "mifepristone is indicated for the termination of pregnancy but is also prescribed in a medical emergency to treat ectopic pregnancy, preeclampsia, and other emergent medical presentations during labor and delivery and for the medical management of a miscarriage."
The concern is that care is being disrupted, and patients who need the drugs in question for reasons other than pregnancy termination are having challenges getting them.
"Many health care professionals, including physicians and pharmacists, are uncertain of their legal liability related to prescribing and/or dispensing these medications regardless of whether they are being used for an abortion or another indication," the pharmacy groups and AMA write. They cite several examples of issues caused by a lack of clarity in state policy and point out that patients appear to be facing delays or denials in accessing medications for medically necessary purposes Those include:
• Health systems and hospitals following legal advice to no longer provide certain medications
• Removing emergency contraceptives (which are not abortifacients) from kits used to care for victims of sexual assault because the legal risk is too unclear
• Policies requiring pharmacists to reject prescriptions unless they follow new, burdensome processes, such as confirming a female patient's diagnosis with the prescriber for every potential abortifacient even when the medication has multiple uses.
The statement asks that state policymakers take patient care into account and make sure "physicians and pharmacists shall be free to continue to practice medicine and pharmacy without fear of professional sanction or liability."
The Guttmacher Institute points out that medication abortion has been available in the United States since 2000, when the FDA approved the use of mifepristone for early nonsurgical abortion. The research and policy organization on sexual and reproductive health notes that medication abortion currently is approved for use up to 10 weeks of gestational age but is considered safe off-label at later gestation. While courts have ruled that banning medication abortion completely is unconstitutional, some state-level restrictions have gone into effect without being legally challenged
As of the beginning of September, 29 states require clinicians who administer medication abortion to be physicians, two states prohibit the use of medication abortion starting at a specific point in pregnancy, and 19 states require the clinician providing medication abortion to be physically present when the medication is administered, which prohibits the use of telemedicine to prescribe medication for abortion.
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