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The Real 'Danger' Is Reclassifying Abortion Pills as Controlled Substances

— Louisiana's new law threatens the health and safety of pregnant women

MedpageToday
A photo of a box of mifepristone tablets and a bottle of misoprostol tablets.
Sukhavasi is an ob/gyn based in Louisiana.

The importance of resilience in medicine is something that has been emphasized to medical students, residents, and attending physicians over the past several years. It is the ability to bounce back after a tough day at work, just so you can do it all over again the next day. In my field of obstetrics and gynecology, this is often seen and felt as the nerve-wracking emergency cesarean section, the hysterectomy with an unanticipated complication, or the bad news delivered to a patient before running off to another delivery.

The past few years have been even more emotionally taxing for many of us as full-scope ob/gyns. Taking care of pregnant people, those trying to achieve pregnancy, and those who do not want to be pregnant is the foundation of our profession. Since the Dobbs decision from the Supreme Court in June 2022, which overturned the federal protections of Roe v. Wade for essential abortion care, physicians in many states have seen new restrictions on how we are able to practice medicine and care for our patients. In Louisiana, one more just went into effect last week.

A Changing Policy Landscape

In the 2 years since Dobbs, we've seen major consequences for patient care. Idaho has lost and 55% of its maternal fetal medicine specialists. In a state with already low numbers of physicians, that is devastating for the healthcare of its residents. Texas has seen maternal mortality rates from 2019 to 2022. In addition, there has been a rise in infant deaths in the state, up 12.9% in comparison to the nationwide 1.8% increase since the strict SB8 law took effect, banning abortion once a fetal heartbeat is detected. Georgia's maternal mortality review committee recently determined that in the state , and likely tied to the state's strict abortion ban.

In Louisiana, we now face a unique challenge with a new law that classifies mifepristone and misoprostol -- two medications commonly used and commonly prescribed by ob/gyns -- as . Other medications in primarily include benzodiazepines, barbiturates, opioids, and stimulants. You may recognize some of them as carisoprodol (Soma), alprazolam (Xanax), and tramadol (Ultram), medications that are prescribed by healthcare providers but do have potential for harm in terms of abuse and dependence.

Despite mifepristone and misoprostol having extremely well-documented safety profiles and a number of indications for use both in and outside reproductive health, these medications are under scrutiny due to their association with medication abortion in a conservative political climate. Placing these drugs unnecessarily alongside those with abuse potential stigmatizes very common diagnoses related to miscarriage and abortion even further.

While mifepristone can be used in combination with misoprostol for termination of pregnancy up to 10 weeks, it is also used for miscarriage management, early pregnancy loss, and for treating elevated glucose in patients with Cushing syndrome. Mifepristone is already regulated under the REMS (risk evaluation and mitigation strategy) requirements for reproductive health indications , mandating the use of prescriber or pharmacist certification and completed Patient Agreement Forms. In addition, since 2000 have shown that "serious side effects occur in less than 1% of patients, and major adverse events -- significant infection, blood loss, or hospitalization -- occur in less than 0.3% of patients."

Misoprostol is prescribed by virtually every ob/gyn in the country for a variety of indications, including induction of labor, miscarriage management, early pregnancy loss, treatment of postpartum hemorrhage, and aiding in dilation of the cervix for gynecologic procedures such as intrauterine device (IUD) insertion and hysteroscopy. It is FDA-approved for prevention of gastric ulcers in people taking nonsteroidal anti-inflammatory drugs, and in combination with mifepristone for abortion and miscarriage management.

The Impact of Reclassifying Abortion Medications

After Dobbs, we already experienced delays in care related to the dispensing of these medications due to confusion surrounding the state's abortion restrictions. For example, I (and many of my colleagues) had to speak to outpatient pharmacists who were hesitant to fill our misoprostol prescriptions out of fear that it was being used to induce abortion and would lead to criminal liability. This led to delayed treatment of diagnoses such as missed abortions, and even a canceled surgery, when a postmenopausal woman was not able to get her pre-procedure misoprostol to aid in dilating her cervix prior to a hysteroscopy. Now that mifepristone and misoprostol are controlled substances, we may see more referrals to tertiary centers for treatment of miscarriages and abortion care, as many community clinics are staffed with mid-level providers who do not all have DEA licenses, which will now be a barrier to prescribing these essential drugs.

Regulating these medications may affect physicians working in Louisiana health facilities in different ways. If your labor and delivery unit already keeps all medications in a Pyxis or other secure facility, then you may not feel any significant effects. However, if your medications are stored in hemorrhage carts or elsewhere, your pharmacists, nurses, and physicians are likely having to come up with new workflows and processes that may add additional time to the retrieval of these medications in urgent situations, such as postpartum hemorrhages.

Misoprostol is typically my initial medication for a postpartum hemorrhage as it is safe, cost-effective, and easy to administer. Any additional time required to obtain it may increase the risk of blood loss, need for transfusion, or the need for additional medications or surgical interventions. There are alternative effective medications for treatment of hemorrhage; however, some -- such as methylergonovine (Methergine) and carboprost (Hemabate) -- do have contraindications, so they are not suitable for every patient. Postpartum hemorrhages also occur in emergency departments and postpartum floors, where misoprostol is going to be even less accessible in a situation when urgently needed.

Will this change in the law lead to delays in care? Likely. Will this change in the law lead to devastating consequences and an increase in maternal morbidity and mortality? Possibly, but I hope not. If we don't see immediate negative outcomes, it is not because the law hasn't interfered with the care we can provide patients; it is because this is yet another hurdle that physicians and healthcare providers have been forced to navigate to continue to provide the excellent care we know our patients deserve.

Physicians will continue to be resilient and work through the challenges that our political climate brings to care. However, it is a slippery slope when laws claiming to be intended to prevent the rare occurrence of "coerced criminal abortion" instead cause real harm to patients.

is an ob/gyn based in Baton Rouge, Louisiana and a Physicians for Reproductive Health fellow.