Issue Brief: Access to Mifepristone and Misoprostol in the Clinical Setting
Overview
Politically motivated efforts by legislators to block off any avenue to access abortion care have targeted mifepristone and misoprostol, two drugs that form the standard medication abortion regimen when used in combination—and that individually play key roles in maintaining and preserving the health of pregnant patients, including those experiencing medical emergencies. This legislative interference is based in ideology, not data, and disrupts existing and well-established patient care protocols, putting patients’ lives at unnecessary risk. Physicians must be able to access mifepristone and misoprostol readily, quickly, and without unnecessary barriers to provide essential care to patients as efficiently as possible, especially in time-sensitive situations.
Clinical Uses of Mifepristone and Misoprostol
Mifepristone and misoprostol are used for a variety of indications aside from abortion care within the field of obstetrics and gynecology. Misoprostol, for example, is used routinely for labor induction, miscarriage management, and cervical softening prior to procedures such as biopsies to rule out uterine cancer. It is also critically employed to prevent and control maternal hemorrhage—which is responsible for 14% of pregnancy-related deaths in the United States.
Despite the decades of evidence proving that mifepristone and misoprostol are safe and effective and the wide-ranging scope of their usage in clinical treatment, these drugs are stigmatized and their use and availability are made subject to legislative interference because of their ability to facilitate medication abortion when used at certain dosages.
Why does reclassifying mifepristone and misoprostol as controlled substances harm physicians and patients?
Reclassifying mifepristone and misoprostol as Schedule IV controlled dangerous substance drugs creates unnecessary extra layers of rules and regulations between safe, effective medication and the physicians and patients who need it. This can and will delay treatment in dangerous ways. For example, under Louisiana law, mifepristone and misoprostol must be stored with other controlled dangerous substances: in some hospitals, they may be locked away in a secured cart that is used to limit access; in others, they may require a pharmacist’s support to obtain. Other hospitals, including rural and community hospitals, do not have the ability to stock controlled substances, meaning that mifepristone and misoprostol would no longer be available to patients at those facilities.
When it comes to administering lifesaving care, the difference between life and death can come down to a matter of seconds. Evidence-based guidance created by experts for the Alliance for Innovation on Maternal Health, a nationwide commitment focused on disseminating and supporting best practices that promote improved maternal health outcomes, recommends that a hemorrhage cart that provides immediate access to medications such as misoprostol be readily available for all deliveries. The time that physicians will now need to spend obtaining approvals to use the drug and retrieving it from its secured location, on top of the time already spent determining whether the drug can legally be used in the medical emergency that their patient is experiencing, is time diverted from performing procedures or administering medication that could save a patient’s life—time that a patient in distress may not have.
Moreover, restricting access to mifepristone and misoprostol introduces needless administrative delays into the process of caring for patients. Hospitals will be forced to review and restructure rules and protocols that do not need restructuring to create revisions that will not improve patient care or outcomes. Physicians will be forced to grapple with new, dangerous regulations that contradict evidence and their training, in addition to dealing with laws that criminalize evidence-based reproductive health care.
ACOG vehemently opposes this callous attempt to restrict access to abortion care, and the collateral harm that legislators will cause in pursuit of that goal.
Recommendations
Mifepristone and misoprostol should be readily available to all qualified health care professionals in the clinical setting. Policymakers should oppose any attempt to further restrict access to these vital medications.