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DENVER (KDVR) — A new state law impacting how the drug ketamine is used to sedate extremely agitated people outside of a hospital setting will take effect when and if Colorado Gov. Jared Polis signs the legislation in the coming days.

“We are carefully reviewing the final bill,” a spokesperson told FOX31 in an email.

The general assembly approved the legislation, which limits the circumstances in which the drug can be administered, earlier this month. 

Study: mortality is rare but decreased respiratory rates need monitoring

According to a recent study, Out-of-Hospital Ketamine: Indications for Use, Patient Outcomes, and Associated Mortality, published in the Annals of Emergency Medicine, and conducted by researchers at ESO, mortality associated with ketamine administrations outside of a hospital, was “rare.”

The study involved 11,291 patients who were given the drug outside of a hospital setting in 2019, including 3,795 patients who received the drug for behavioral reasons like agitation or an altered mental status.

Of those patients, 23% suffered decreased respiratory rates after a ketamine administration, according to researcher, Dr. Brent Myers, the chief medical officer at ESO.

“It’s significant enough… that we really should be monitoring these patients very closely,” he told the Problem Solvers.

“We really need to think about, ‘Are we giving our medications for the right reasons, for the right indications, to the right patients?'” he said.

Myers also said the study helped researchers learn that in general, EMS providers “are giving this medication in the right dosing range, the range that has been approved.”

“We were encouraged by that,” he said.

Ketamine’s role in Elijah McClain’s death

The FOX31 Problem Solvers have been reporting on and investigating whether the drug has been used appropriately and with adequate training in Colorado since 2019, when Elijah McClain died.

McClain passed away following a police altercation in which Aurora police officers used a carotid hold technique, briefly restricting blood flow to his brain, and after McClain received a dose of ketamine from paramedics.

An autopsy found his manner and cause of death were undetermined, but the doctor who conducted the exam said, “…an idiosyncratic drug reaction (unexpected reaction to a drug even at a therapeutic level) cannot be excluded.”

An independent consultant hired by the City of Aurora found that medical officials did not adequately assess McClain’s condition prior to administering ketamine. The report found they “stood back and did not render aid to Mr. McClain for several minutes until a paramedic administered ketamine.”

While a medical consultant hired by the City of Aurora said she found no definitive evidence that the drug led to McClain’s death, she said it might have affected a medical professional’s ability to properly assess McClain’s medical needs.

“If anything, the ketamine may have contributed to some difficulties on the part of the paramedics after his sedation of assessing the fact that he was continuing to decline,” said Dr. Melissa Costello.

A FOX31 investigation also discovered the paramedics overestimated McClain’s weight prior to administering the weight-based drug.

The City of Aurora stopped using the drug to sedate patients, indefinitely.

The complication rates of ketamine

According to Colorado Department of Public Health and Environment records, 5.28% of cases involving pre-hospital ketamine administrations for extreme agitation in 2018 involved one or more complication.

The health department said some complications it tracked “may not be directly related to the ketamine administrations.”

In 2019, Randy Kuykendall, the director of CDPHE’s Emergency Medical Services Division said of the 2018 complication rate, “it isn’t overly concerning. It bears monitoring. Always. Because that is a number that we don’t want to see go up. If we do see that start going up, then it begins to question the efficacy of either the drug, the training, (or) how it’s being used.”

The 2019 complication rate, which CDPHE said was gathered in the same way across years with “no significant changes” to the way data was collected, showed a 24% complication rate.

The 2020 complication rates are not finalized, so they cannot be released at this time, according to CDPHE.

Legislators Look into ketamine cases

State and federal legislators, meanwhile, were compelled to learn more about the use of ketamine to sedate agitated patients after FOX31’s continued reporting on McClain’s case and others in which the drug was used, including the cases of Elijah McKnight and Jeremiah Axtell.

Mcknight ended up on a ventilator and spent several days in the hospital after he received two 750mg doses of the drug, enough for a 330-pound patient according to protocols, when Mcknight weighed approximately 210 pounds.

Prior to the ketamine administration, Mcknight was involved in a drunken altercation with sheriff’s deputies in which police used an electric shock device on him multiple times and cuffed him. Deputies also held his legs down while he was physically restrained. 

A ketamine researcher and emergency medical physician who reviewed McKnight’s case for the Problem Solvers  said the second dose McKnight received likely was not necessary.

“The medication seems to be taking effect and sedating him. Probably a second dose, it would be reasonable to really hold off. You probably want to use the minimum amount,” said Dr. Joshua Solano, an assistant professor at the College of Medicine at Florida Atlantic University

However, the Colorado Department of Public Health and Environment found no reason to discipline providers in his case and found the paramedics complied with applicable protocols.

South Metro Fire Rescue, the agency that administered the ketamine, also said its paramedic followed protocols but could not provide any supporting documentation of its findings after a self-review.

Axtell, while in handcuffs after a verbal altercation with his neighbors, told authorities he would
cooperate 100%,” but paramedics proceeded to sedate him after that.

The state health department said it found no grounds to take disciplinary action against any of the providers.

However, both men are now suing their medical providers in federal court.

The health department provided no records to the Problem Solvers and would not provide interviews about either case to explain their findings.

The Problem Solvers also recently reported on the case of Steven Reycraft, who was given the drug by a Manitou Springs paramedic after he was in a verbal and physical altercation with police.

What’s in the proposed ketamine law

The proposed law, which was introduced by state Rep. Leslie Herod (D-Denver), and Rep. Dr. Yadira Caraveo (D -Adams), would prevent medics from administering the drug “absent a justifiable medical emergency.”

Currently, various local agencies’ medical protocols and the most recent state guidance on the drug references the term, excited delirium, as an extremely agitated condition for which the drug may be administered.

The state’s ketamine waiver guidance describes the condition as “a rare medical emergency in which a person develops extreme agitation, aggressiveness, overheating, and exceptional strength that cannot be managed by routine physical or medical techniques. Excited delirium patients lose their mental capacity to stop resisting and are truly out of control.”

However, the new state law, should it go into effect, prevents the drug from being administered for this reason.

According to a statement from the Colorado Department of Public Health and Environment, the agency is “reviewing the legislation passed at the statehouse and are prepared to adjust the program swiftly to the be (sic) compliant.”

Emergency crews said McClain was “suffering from possible initial stages of excited delirium,” when they gave him the drug in 2019.

McKnight’s patient care record shows medical crews said he “appeared to be in excited delirium” when he received the drug in 2019.

In Axtell’s patient care record, he was described as “in excited delirium” even though he was able to communicate with officials to say he would fully cooperate with them prior to his sedation.

American Medical Association opposes excited delirium as a medical diagnosis

In June, the American Medical Association opposed the term “excited delirium” being used to describe a legitimate medical diagnosis and warned against the use of ketamine and other pharmacological interventions “solely for a law enforcement purpose without a legitimate medical reason.”

Colorado’s proposed state law specifically says, “excited delirium, any subsequent term for excited delirium, or any acute psychiatric diagnosis not recognized in the most recent edition of the diagnostic and statistical manual of mental disorders is not a justifiable medical emergency.”

What else is in the proposed law?

Under circumstances in which a peace officer is present on the scene, appropriately trained emergency medical service providers will only be able to administer ketamine if they’ve either weighed the patient or if they’ve agreed on the patient’s estimated weight with at least two other trained personnel.

In addition, they also must have attempted to obtain a verbal order from a medical director to administer the drug and have proper equipment available to manage respiratory depression and monitor the vital signs of a patient.

The ketamine bill also includes penalties for peace officers who direct or “unduly influence the use of ketamine upon another person.”

Two Colorado Congressmen, Rep. Joe Neguse and Rep. Jason Crow also proposed federal legislation in June that would prohibit paramedics from using ketamine in certain situations.

Other deaths: Jerica Lacour

While death linked to a ketamine administration outside of a hospital setting is rare, the Problem Solvers found a 2018 case linked to the drug in El Paso County. 

Jerica Lacour, a 29year-old mother of five, died “as a result of respiratory arrest associated with acute alcohol and ketamine intoxication,” according to the autopsy report, signed by Dr. Emily Berry. 

“It is also my opinion that cardiomegaly, cardiac fibrosis, obesity, and recent cocaine ingestion contributed to death,” she wrote, referring to Lacour’s death as an accident.

The Colorado Department of Public Health and Environment could not confirm whether Lacour’s death had been reported to the state health department as regulations required, but a spokesperson told the Problem Solvers CDPHE is now investigating the incident.

“We have no record of a report involving the death or complication involving someone by that (Lacour’s) name,” said Gabi Johnston, a spokesperson for CDPHE.

Johnston said all deaths or known complications involving pre-hospitalization administration of ketamine must be reported.

“Because of your inquiry, we obtained additional information and opened an investigation,” said Gabi Johnston in an email.

Johnston said CDPHE initiates investigations based on complaints with cases involving the pre-hospitalization administration of ketamine or because the department receives information that state regulations have been violated.

“We have not received a complaint concerning that individual,” said Gabi Johnston, a spokesperson.

The FOX31 Problems Solvers also asked the involved medical directors and agency whether they reported Lacour’s death to CDPHE in 2018, but they have not yet confirmed what happened in 2018.

To date, CDPHE said statewide, medical directors have only reported two deaths to CDPHE since the first ketamine waiver was issued for sedation in 2011.

The first Colorado ketamine waiver for “excited delirium” was issued in 2013.

What Happened to Jerica Lacour

According to a sheriff’s office report obtained by the Problem Solvers through an open records request, Lacour’s breath had a “strong odor of alcoholic beverages,” when law enforcement and medical crews encountered her in a truck yard.

She was wearing torn pajama pants and a short-sleeved shirt.

A deputy said, “I was unable to make out most of what she was saying due to her erratic behavior.”

Body camera footage shows Lacour crying hysterically about her children prior to being transported by a medical crew.

According to the sheriff’s report, “Medical arrived on scene and began to treat Lacour for what was believed to be heavy intoxication with the possibility of having unknown drugs on board. As Lacour was placed on the gurney by medical staff she began physically attempting to resist their efforts. Medical applied soft restraints to her wrists and then gave her a shot of ketamine.”

In the video, a male’s voice can be heard taunting the patient, “Guess who gets ketamine?”

Lacour’s family never saw the video of her final moments alive, and they have many questions about how she died.

“Nobody could tell me what happened, so for these three years, we’ve had not closure about what happened,” said Rebecca Blanchard, Lacour’s mother.

Medical Examiner explains ketamine-related deaths

According to the El Paso County Chief Medical Examiner, “ketamine-related deaths are exceptionally rare, and there are only a few unique circumstances when we typically see them.”

The majority of incidents in which significant effects of ketamine are noticed in death are “almost always in the setting of other significant drugs,” said Dr. Leon Kelly, the Chief Medical Examiner in El Paso County.

Kelly did not conduct the autopsy on Lacour, but he said ketamine can be both therapeutic and toxic depending on the other circumstances and substances present when the drug is given.

“All medications have the potential to be toxic. In a hospital setting, we have the advantage that the anesthesiologist can sit. They can meet with the patient. They can talk about adverse effects that they’ve had in the past,” he said.

“In an outside-hospital setting, particularly an urgent, critical-type situation, you don’t have that opportunity.  The person may not be in a mental state where they can carry on that type of conversation, and in those cases, you’re using a drug that under the vast majority of situations can be used appropriately, effectively, safely, gets the effects that you want. You’re going to have situations where just the wrong thing is present. The wrong drugs are on board with that person, or they’ve got pre-existing disease that you may not know that makes them more susceptible to some of those adverse reactions,” he said.

“We can’t fool ourselves and think that ketamine is some sort of magical drug that never causes problems. That’s not true,” said Kelly.

Other deaths: Hunter Barr

In September 2020, Hunter Barr died in El Paso County after paramedics administered ketamine while he was high on LSD and cough suppressants.

A doctor who conducted his autopsy said Barr’s death was the result of “toxic effects of ketamine in the setting of dextromethorphan (cough suppressant) and lysergic acid diethylamide intoxication (LSD).”

“It’s critical that we examine these cases where death and negative consequences have occurred,” said Kelly, who did not conduct the autopsy. “That’s the only way we’re going to do better later.”

Barr’s father, Mark Barr, described his son as an artist and self-taught musician who loved riding rollercoasters with his dad as a kid. “He just loved everything,” said Barr. “He was just a really good guy, and his friends say the same thing about him. If they needed him to do something for them, he was there.”

Barr said he called medical professionals to help when his son started acting strangely, but he never thought his son would die after they arrived.

“It was kind of hard to hear that the people you had called to try to help him was the cause of his death,” said Barr.

Body camera footage shows Hunter Barr, 26, falling out of his front screen door and being approached by police officers who cuffed him when they contacted him.

Barr moved lethargically and occasionally grunted expletives as police and medical crews tended to him.

Mark Barr said he wasn’t sure why his son was given a sedative when the young man was physically controllable. 

“They already had him subdued on the ground with his hands cuffed behind his back,” said Barr.

“I read things that ketamine is good for certain things, but you know, sometimes, when it’s intermixed with other drugs, it’s not,” he told the Problem Solvers.

What’s the regulatory agency doing about all this?

The last time a medical or administrative official from CDPHE agreed to answer questions during an on-camera interview with the Problem Solvers was 2019.

In the last year, CDPHE has denied or ignored at least 19 written requests from the Problem Solvers for on-camera interviews about ketamine and how CDPHE, as a regulatory agency, is addressing potential changes in regulations due to the impending proposed state law, increasing complication rates, proposed federal legislation, changes in policy at the AMA, and questions from the public about when and how the drug should be used in a pre-hospital setting.

When the Problem Solvers reminded CDPHE about the number of interview denials, they offered a few written statements this June.

“We want your viewers to be aware of the oversight that we are providing with regard to the ketamine program. We acknowledge the need to audit the program and are actively doing so,” said Gabi Johnston, the CDPHE spokesperson.

“We are (a) investigating all complaints about specific cases; and separately, (b) conducting a review of the entire ketamine program with the assistance of outside experts and expect to have a report detailing ways to modify the program to further protect public health, and (c) reviewing the legislation passed at the statehouse and are prepared to adjust the program swiftly to the (sic) be compliant,”
the statement said.

While CDPHE has yet to publicly answer questions about how it is interpreting and handling the increased complications rates, some citizens say there is not enough oversight for the drug.

For Anita Springsteen, a Lakewood City Council woman and an activist who believes her boyfriend, Axtell, was wrongfully injected with the drug in 2020, there is not enough accountability.

“We do not have a proper enforcement mechanism or real, impartial regulation,” she said.

Springsteen, who filed a lawsuit on behalf of Axtell and is an attorney representing Reycraft, said she believes the new legislation will not go far enough.

“It doesn’t address the issue of, ‘why are paramedics not properly trained?'” she said. “Why are they not following protocol. Why is there not a state mandate about training and how it should be under each waiver?”

Springsteen said she thinks the public will need to turn to the courts to see more action on this issue.

The long-delayed ketamine review

In August 2020, CDPHE Executive Director Jill Hunsaker Ryan announced that CDPHE would be conducting a “thorough review” of the ketamine waiver program that is regulated by the state.

However, through open records requests for internal emails, the Problem Solvers discovered that review, which was promised to start immediately, did not begin until 2021.

At first, CDPHE blamed the delay an ongoing Attorney General investigation into the death of McClain.

In February, a senior policy advisor for the health department said CDPHE decided to make the review process confidential.

The state health department later issued a statement to the Problem Solvers saying it “typically” does not conduct interviews while it is reviewing one of its programs.

“Broadly, we wanted to acknowledge your requests for an interview, and state that while we are committed to transparency, we didn’t want to disrupt the review committee’s deliberations,” spokesperson Johnston said.

The health department has not indicated when its review will be completed.