Doctors criticize misoprostol guidance from Louisiana Department of Health: ‘It’s not helpful’

16th September 2024   ·   0 Comments

By Lorena O’Neil
Contributing Writer

(lailluminator.com) — Louisiana doctors say they still have plenty of questions about how they will be able to access a life-saving drug once it’s placed under restricted access starting next month – even after state health officials provided them with new guidance on the law.

Earlier this month, the Louisiana Department of Health released a memo with instructions to doctors about how they can use misoprostol in hospitals. Misoprostol has long been one of the go-to options for women who experience excessive bleeding after delivery.

The new law was intended to curtail the use of misoprostol and mifepristone for medical abortions, although they are also used to treat other conditions such as ulcers or some pituitary disorders, respectively. Misoprostol, in particular, is used quite frequently by OB-GYNs to soften the cervix for endometrial biopsies, to induce labor or to insert an intrauterine device.

The health department’s outreach to physicians followed a Louisiana Illuminator report that details “confusion and angst” among health care providers over a new law that reclassifies the misoprostol and mifepristone as controlled dangerous substances. It goes into effect Oct. 1, and doctors have expressed concern that the changes will lead to the vital drug being pulled from postpartum hemorrhage carts.

So far, the LDH memo has done little to reassure the medical community.

It’s “not at all” helpful, said a New Orleans OB-GYN who spoke on the condition of anonymity because she hadn’t received clearance from her hospital to speak to a reporter.

“Whoever wrote this has not spent time on a labor unit,” she said. “This gives no actual guidance to the people who are trying to revise the protocols because it doesn’t actually tell me how to keep track of the drugs on the carts, how often to count them, what to do if we need them, etc.”

The memo tells doctors that mifepristone and misoprostol “may be utilized” to treat postpartum hemorrhage – even though mifepristone is not used for hemorrhaging. The two drugs can be used together for medical abortions but are not interchangeable for other indications.

Setting that error aside, doctors’ main concern with the new law is delays in having access to misoprostol because it would have to be stored as a controlled substance. Any holdup in administering the medicine when a patient is bleeding profusely could significantly worsen outcomes.

“Saying that it’s permissible to have them available is actually kind of offensive – we know that,” the New Orleans-based OB-GYN said. She added that it’s also confusing that LDH uses the term “crash cart” because it could be confused for a maternal code blue cart, which is completely distinct and is not related to postpartum hemorrhage medication.

“We were hoping for more guidance on how to have miso available at the bedside because no other controlled substances can ‘float around’ in the hospital like that,” the OB-GYN said. “We were hoping to have guidance on what diagnosis codes are required in order to fill a prescription [for misoprostol] based on the document from the Louisiana Board of Pharmacy that was released this summer.”

‘Unlikely to be a viable solution’
The state’s board of pharmacy referred to the law in its July newsletter, explaining that the reclassification is part of a law that created the crime of coerced abortion, when a pregnant woman is drugged with abortion medication without her consent.

“A diagnosis or a diagnosis code shall be written on the prescription by the prescriber indicating that the drug is intended for a purpose other than to cause an abortion in violation of this Section of law,” the newsletter states.

LDH sent a copy of its memo to the Illuminator late Friday afternoon, saying the guidance had been issued to health care providers earlier in the day. The department “distributed the memo and guidance to providers through various channels via statewide communications,” LDH press secretary Kevin Litten said.

Four doctors the Illuminator contacted after receiving the memo were not yet aware LDH had issued any guidance.

Dr. Jennifer Avegno, health director for the City of New Orleans, received a copy of the memo from LDH after speaking to a reporter. She said she doesn’t know how the information will be shared with doctors across Louisiana.

The state health department has two main ways to communicate quickly with providers when they need to, Avegno said. One is a Health Alert Network message that immediately alerts physicians. Another is through the Louisiana State Board of Medical Examiners, which has a database of all licensed physicians in the state. Neither has been used thus far to her knowledge.

The new law requires the state to educate health care providers on how the reclassification of the two drugs will affect their treatment protocols.

“It’s not helpful,” Dr. Stacey Holman, division director at Touro’s maternal child services, said after reviewing the document.

Secure storage not practical
The memo suggests securing misoprostol and mifepristone, the latter of which is not used for postpartum hemorrhages, in a secured automated dispensing system. Holman said these very large machines are not housed inside patient rooms.

“This still creates a delay for a patient who needs the drug urgently as many of the patient rooms are not close to these systems,” she said.

The LDH’s suggestion that scheduled drugs be stored in a locked area of an obstetric hemorrhage cart “may be good in theory.”

“But to do this safely, in accordance with the additional rules now imposed for these drugs, an oversight process requiring more extensive record keeping and pharmacy manpower will be required,” Holman said. “This is unlikely to be a viable solution for most hospitals, especially those in critical access areas.”

After being contacted by a reporter, a family medicine OB practicing at a rural Louisiana hospital reviewed the letter. She asked not to be identified because she wasn’t authorized to speak on the hospital’s behalf.

“That’s all so confusing,” she said. “I don’t even understand most of that document. Nothing is made clear really. What is a secure area?”

She referred to an auto-dispensing system, which in her hospital is called a Pyxis, and said it is an extremely expensive piece of equipment. It wouldn’t be economically feasible to have multiple Pyxis machines on a hospital floor, she said.

“We cannot afford hospital beds with proper stirrups or to even have lidocaine always available,” she said. Her hospital currently uses what she called a “bleed box” – a small plastic box shut with zip ties.

The rural doctor added that her department’s Pyxis is down the hall from the delivery unit in a locked room. The machine won’t open without an order verified by a pharmacy. On nights and weekends, her hospital has to call out to a remote pharmacy.

“Even an in-house pharmacy would take more time, when a lady is gushing liters of blood,” she said. “I often get covered in it.”

Avegno said she hopes more guidance is coming from LDH. She was among 50 doctors who signed an Aug. 22 letter to the department requesting more information on the new law, which Gov. Jeff Landry signed in May.

“They addressed some of the questions that we raised in our letter, but they did not address others,” said Avegno, an emergency room physician. “We asked for specific guidance on prescriptions … in order to make sure that it complied with the act and had the highest chance of being filled for a medically necessary use – and they did not address that at all.

“They appear to address some of the issue of inpatient access, but I am checking with some pharmacy colleagues to see if some of the things that they suggest can happen readily or are going to require a lot of work on each individual hospital’s part.”

Touro’s Holman said she would also like more guidance.

“Creating policies and procedures to explain this could take weeks to months to write and approve,” Holman said. “We have 23 days to figure this out. Just 23 days to test and implement solutions as well as educate physicians on how we are going to continue to provide safe care for our OB patients.”

Pressure on LDH to provide guidance increased this week after the Illuminator’s report, which prompted a statement from Vice President Kamala Harris’ campaign, blaming former President Donald Trump for Louisiana’s law further restricting access to reproductive health care.

“Because of Trump, doctors are scrambling to find solutions to save their patients and are left at the whims of politicians who think they know better,” Harris-Walz spokeswoman Sarafina Chitika said.

This article originally published in the September 16, 2024 print edition of The Louisiana Weekly newspaper.