Hospital conducts drills ahead of new Louisiana law for pregnancy care drugs

NEW ORLEANS — Less than two weeks before a controversial Louisiana law reclassifying common pregnancy care pills as controlled dangerous substances takes effect, doctors are trying to prepare for what delays in accessing life-saving medication could mean.

In one New Orleans-area hospital, they are already practicing timed drills , running from delivery rooms to the locked medicine cabinet where controlled substances are stored, to see how long it will take. In one recent drill, it took more than two minutes for doctors and nurses to retrieve misoprostol for a pretend patient who was bleeding out.

"Every second counts," a doctor involved in the drill told the Illuminator. The OB-GYN asked to not be identified because she did not have permission from the hospital to speak to the media. "Two minutes could leave a massive hemorrhage requiring additional medications, need for blood transfusion and even the need for additional surgery."

When the law goes into effect Oct. 1, misoprostol will be removed from her hospital's postpartum hemorrhage carts that are wheeled into delivery rooms for easy access, she said. Instead, the drugs will be stored in a passcode-protected dispensing system centrally located in the labor and delivery unit, not in proximity to patient rooms.

The doctor said the drill consisted of timing the difference between having immediate access to the cart, and having a nurse leave the room, run to the dispensing system and obtain the medication and run back to the bedside.

Misoprostol and mifepristone will become Schedule IV drugs in Louisiana, which calls for health care facilities and pharmacies to follow certain storage, security and prescription guidelines. Hundreds of doctors in the state have publicly aired their concerns that this new status could delay vital medical treatment.

The drugs can be used to induce abortion but also have other uses such as treating ulcers or managing pituitary disorders. Misoprostol is used to treat hemorrhages after delivery.

"I would encourage every doctor in a hospital to [conduct drills]," said Dr. Jennifer Avegno, director of the New Orleans health department. "I would encourage every woman who is pregnant or thinking about getting pregnant to have conversations with their provider prior to delivery about what the drug setup is in the hospital. This has to go in every birth plan."

Avegno confirmed that one New Orleans-area hospital will remove misoprostol from its obstetric hemorrhage carts but declined to identify which one.

At Avegno's direction, the city's health department will investigate the impact of the legislation once it takes effect, collecting data on whether the law leads to delays in care. While there are outpatient concerns that pharmacists will refuse to fill prescriptions for misoprostol — which is used to soften the cervix for miscarriage management and a number of procedures — an urgent concern is any delay it creates for hospital physicians trying to stop or prevent a patient from bleeding profusely after giving birth.

Misoprostol has usually been stored in easily accessible postpartum hemorrhage carts or kits. When a medication is designated as a controlled dangerous substance, it creates additional, tightly regulated requirements in terms of reporting, storing and monitoring the drugs.

The Louisiana Board of Pharmacy regulates the handling of controlled substances. Its administrative code says, "Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet."

The Louisiana Department of Health issued guidance earlier this month via a memo , saying a hospital "may authorize certain scheduled drugs to be included in a locked or secured area of an obstetric hemorrhage cart" with approval from the hospital's chief medical officer and pharmacy director.

Each policy calls for the medication to be secured, but doctors say the lack of details has led to confusion. Without more specific information, caregivers fear criminal consequences if they run afoul of the new law.

Plus, LDH's licensing standards for hospitals call for Schedule IV drugs to be locked up.

"All controlled substances shall be kept separately from other non-controlled substances in a locked cabinet or compartment," the standards say. "Exceptions may be made, if listed in the pharmacy policy and procedures manual and deemed necessary by the director of pharmacy, to allow some abusable nonscheduled drugs to be maintained in the same locked compartment."

Attorney General Liz Murrill's attempt to bring legal clarity to the situation has not answered doctors' questions. She released a lengthy statement Tuesday, saying the health department's guidance is "clear that no care should be delayed." She placed emphasis on the term "secure" from LDH's letter, even going as far as including the Merriam-Webster definition of the word.

"The term 'secure' used by LDH in its regulation is not vague," Murrill wrote. "LDH's use of this term provides hospitals and other providers dealing with emergent situations, such as a miscarriage or bleeding, maximum flexibility to access these medications if they are needed."

However, doctors who rely on misoprostol daily to save lives say they are still concerned about what this will mean in practice.

Several physicians the Illuminator interviewed found the guidance confusing and unhelpful and have sought additional guidance from the state health department on how to proceed. Obstetric hemorrhage carts do not have a locked compartment, so doctors have asked for examples of how they can modify their equipment while still complying with state law.

One rural doctor, who did not receive permission from her hospital to speak on its behalf, told the Illuminator she asked a nurse for a medication this week that was locked in the hospital's auto-dispensing Pyxis system. The nurse forgot the Pyxis password, which changes regularly, and other nurses were busy. So the doctor had to wait an extra 3-4 minutes until the patient received their medication.

When it comes to postpartum hemorrhages, doctors say these minutes are critical. The longer the delay in accessing the medication, the more blood a patient risks losing.

"Blood is always in short supply," the physician said, highlighting the extra challenges rural doctors could face in the wake of this new law.

Dr. Veronica Gillispie-Bell, a New Orleans-area OB-GYN, reviews every maternal death in Louisiana on behalf of the state health department. On Wednesday, she came out in opposition to the legislation reclassifying misoprostol and mifepristone. Her stance is notable, given her standing as the state's medical director for perinatal care.

"I now have to worry about laws that are created that interfere with my ability to give my patient the best care. Where does this end?" Gillispie-Bell told WWNO-FM . "And I think the real answer to that question is there is no place that it ends, and that is very scary."

From 2016 to 2019, severe maternal morbidity due to hypertension and postpartum hemorrhage decreased almost 40% in Louisiana. Public health advocates say this is largely thanks to hospitals putting protocols in place, such as easy access to life-saving medication in obstetric hemorrhage carts.

"But it's literally taken years, if not decades for hospitals to have these protocols function as well-oiled machines," said Dr. Jane Martin, a maternal fetal medicine specialist in New Orleans. "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."

The New Orleans health department hosted a webinar Thursday for physicians and pharmacists to help troubleshoot their concerns about the law. They invited state health officials to join but did not receive a response.