Reprinted with permission from The Louisiana Illuminator https://mail.ushealthcarejournals.com/OWA/redir.aspx?C=0wnUA4Uf7rRNMKKwaijUspHMPsARdEV1DiOl8dsH2vs0Mpfj48zcCA..&URL=https%3a%2f%2flailluminator.com%2f2024%2f09%2f03%2flouisiana-women%2f%3femci%3d681f82fd-f169-ef11-991a-6045bdd9e096%26emdi%3d22e5e840-f569-ef11-991a-6045bdd9e096%26ceid%3d572401
When a woman starts bleeding out after labor, every second matters. But soon, under a new state law, Louisiana doctors might not be able to quickly access one of the most widely used life-saving medications for postpartum hemorrhage.
The Louisiana Illuminator spoke with several doctors across the state that voiced extreme concern about how the rescheduling of misoprostol as a controlled dangerous substance will impact inpatient care at hospitals. Misoprostol is prescribed in a number of medical scenarios — it’s an essential part of reproductive health care that can be used during emergencies, as well as for miscarriage treatment, labor induction, or intrauterine device (IUD) insertion.
But because it is used for abortion, misoprostol has been targeted by conservatives in Louisiana — an unprecedented move for a medication that routinely saves lives. A controlled dangerous substance has extra barriers for access, which can delay care.
“My fear is that someone could eventually die,” said Dr. Tara Morse, an OB-GYN who practices at Touro Infirmary in New Orleans. “And that’s not why we all went into medicine. Our goal is to prevent everything and be able to use every drug at our disposal.”
Every hospital has its own system for obstetric hemorrhage care. Some use rolling carts or kits in birthing rooms with easily accessible medications and equipment in case of hemorrhage after delivery.
Misoprostol is a pill often used in early stages of post-delivery bleeding, especially for patients with hypertension or asthma who might have adverse side effects from using other hemorrhage medications that are usually administered by needles or an IV. Misoprostol is also used as a precautionary measure in case doctors think a patient is at risk for hemorrhaging.
In May, Gov. Jeff Landry signed legislation reclassifying misoprostol and mifepristone as Schedule IV controlled dangerous substances, despite more than 200 doctors signing a letter against the measure. The law goes into effect on Oct. 1, and doctors and pharmacists are scrambling to come up with postpartum hemorrhage policies that will comply with the law while still providing proper medical care for women.
We're trying to fix something that is not broken and that is absolutely safe.
– Dr. Stacey Holman, Touro Infirmary maternal child services director
Some hospitals have already preemptively pulled misoprostol from their obstetric hemorrhage carts and kits because controlled dangerous substances need to be stored and accessed differently from other medications.
“It is causing a lot of confusion and angst just not understanding, just not knowing — they’re still trying to figure out what to do,” said an OB-GYN who asked that her name not be used because she had not received clearance from her hospital. She said she’s heard of the medication being pulled off carts at some hospitals.
“The physician community that I work within is certainly anxious about what the changes to the normal process will be,” said Dr. Stacey Holman, division director at Touro’s maternal child services. She added how “frustrating” it is that it’s become routine in Louisiana to have an unclear law attempting to dictate medical practice creating stress on health care providers.
“It’s an unnecessary barrier and really critical to the regular everyday care that we provide to our patients,” she said.
“We’re trying to fix something that is not broken and that is absolutely safe,” Holman said.
Holman said she is not aware of misoprostol being proactively removed from any of Touro’s obstetric hemorrhage carts. But come Oct. 1, “It won’t be in our carts anymore because it [will be] a controlled substance and has to go through the pathways of the pharmacy.”
Alternate drugs are available, but Holman pointed out Touro sees an increased number of hypertensive patients in her community who aren’t able to use one of the primary alternatives. Hypertensive patients are also at increased risk for maternal morbidity and mortality.
“My job is to save the mom’s life, not type out orders on a computer,” Morse said of what the new protocols might look like if doctors have to put in physician’s orders before obtaining the medicine, versus adding the order afterward as is often the case now.
Morse, who occasionally works at rural hospitals in the state, said she’s very worried about how this will impact those facilities — especially ones without in-house pharmacies on nights and weekends.
“I’ve been [at a rural hospital] trying to get a simple headache medication released, and it’s taken 45 minutes,” Morse said. Sometimes doctors have to call a remote pharmacy and leave a voicemail, she said, playing phone tag to get access to vital medication.
“In these [hemorrhage] situations, you don’t have 45 minutes,” Morse said.
While hospitals in New Orleans are attempting to find workarounds for the new law, there are some rural doctors who aren’t even aware the reclassification of misoprostol and mifepristone is happening. One physician in northwest Louisiana who spoke with the Illuminator hadn’t heard that misoprostol was becoming a controlled dangerous substance until a reporter told her about it.
“What? That’s terrifying,” the doctor said. “Take it off the carts? That’s death. That’s a matter of life or death.”
The physician said that if a pregnant patient came into her hospital bleeding out with no IV access, she would automatically use misoprostol as an option. Other medications and tools are not as easily accessible in rural hospitals because they require more resources, whether that’s because they are more expensive or require the use of syringes. Not to mention the more time a patient has to wait for access to medicine, the more blood she loses.
“Blood is always in short supply,” the doctor said of her hospital. “Misoprostol can prevent the need for transfusion.”
The doctor said the pending law likely explains why pharmacists had been “pushing back” when she prescribed misoprostol for outpatient miscarriage management. They’ve been calling her to request clarification on why she prescribed the medication, and one pharmacy refused to fill the prescription. She had to send that patient to a different pharmacy. Her patients often travel hours to see her, and she regularly has to call in misoprostol to help them manage care at home.
On Aug. 22, 50 doctors signed a letter to the Louisiana Department of Health and Surgeon General Ralph Abraham asking for additional guidance on how to safely prescribe and administer misoprostol and mifepristone once the new law goes into effect. They specifically asked for help on the use of misoprostol in the inpatient setting, and “how to ensure it will be readily and quickly available in commonly used obstetric hemorrhage carts.”
“This is a nationally recognized guideline to emergently treat life-threatening postpartum hemorrhage and it is critical that providers are aware and have access to medication without delay,” the doctors wrote, requesting Abraham’s advice be communicated well in advance of Oct. 1.
They had not heard back as of Monday.
The Louisiana Department of Health, the state Board of Pharmacy and Attorney General Liz Murrill did not return requests to explain how they plan to educate health care providers and assist them in making sure care for Louisiana women is not disrupted. A provision in the new law calls for doctors to be educated on how to comply.
“This is a bad drug to be a controlled substance,” says Dr. Jennifer Avegno, director of the City of New Orleans health department and an emergency room physician. “We are putting women’s lives at risk by denying them immediate access to a life-saving drug.”
Avegno adds, “The OB providers that I’ve spoken to are very concerned and very upset about the way this will change their practice, and I don’t blame them.” She likened the situation to delaying a patient in anaphylaxis access to an EpiPen or removing medicine from a crash cart in an emergency room.
“When you need to give blood to a crashing patient, do you want it right there or do you want to have to call somebody to have them walk it down from the blood bank?” said Avegno, who thinks the new law could lead patients to lose more blood.
“Ultimately it will be OK,” Avegno said, adding that doctors will use heroic measures to stop as many tragic outcomes as they can. “But for some people, having that delay or being forced to take a drug that is not the best indication for them will worsen outcomes.”
Louisiana is among the worst states in terms of maternal mortality and morbidity, and Black women are disproportionately at risk of dying due to complications with pregnancy or childbirth. But the state has successfully been reducing death rates due to postpartum hemorrhage.
“The state has done really good work on reducing maternal mortality through hemorrhage over the last several years by very deliberate mechanisms,” Avegno said. “And [with this new law] we run the risk of backsliding.“
Dr. Jane Martin, a maternal fetal medicine specialist in New Orleans, agrees.
“The frequency of severe maternal morbidity and mortality related to postpartum hemorrhage (PPH) has decreased when you look at the last few decades,” Martin said. “What has changed is the push for hospitals and systems to have protocols in place, which I think is what’s brought these bad PPH outcomes down.”
Martin points to a report that shows, from 2016 to 2019, severe maternal morbidity due to hypertension and postpartum hemorrhage decreased by almost 40% in Louisiana, solely due to standardization of processes.
“But it’s literally taken years, if not decades for hospitals to have these protocols function as well-oiled machines,” Martin said. “When we change these protocols that work so well, we are introducing a significant opportunity for errors, lapses and delays in care, and worse maternal outcomes solely because we are messing with a process that works well and now has to be re-learned.”
When asked about the status of misoprostol at its hospitals, Ochsner Health System said it is “working to get more information about the postpartum hemorrhage carts and additional impacts of the new regulation.” A spokesperson said communications about the impacts of the new state law will be shared with their physicians in the weeks ahead, and that Ochsner will provide official comment once that has occurred.
Ochsner did not disclose whether the medication has been preemptively removed from carts and kits at their hospitals. The health system owns or operates 46 hospitals in the Gulf South region.
LCMC Health runs eight acute care hospitals in the New Orleans area that the new law would impact. Dr. John Heaton, its president and chief medical officer, provided this statement:
“Maternal health is a top priority for our community of patients. We are dedicated to fostering collaborations with physician leaders, nursing leaders, and pharmacy leaders to develop innovative solutions that comply with all legal standards. We are committed to safe care of the highest quality in our birthing hospitals.”
Holman, director of maternal child services at Touro, said that as the largest birthing hospital in the LCMC system, her hospital is working to support others in the system to determine their protocols.
“We don’t want to scare the patients, but we certainly want to make sure people understand that this is a big deal,” Holman said. “Our goal is to minimize how much we impact the logistics of each hospital, but every hospital will be impacted in some way.
“We are not going to put patients in harm’s way. We are going to figure out solutions to this, but we’re going through a lot of steps and figuring out a lot of things for a medication that is actually safe.”