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March 28, 2022

What Doctors and the Medical Field Need to Know About Ketamine and Malpractice Risk

Max Schloemann

Throughout history, researchers, doctors, and other medical personnel have worked to find anesthetic agents that made treatment less painful. Many different types have been tried, and propofol became a preferred drug used for anesthesia in the 20th century. But recently doctors are increasingly turning to ketamine as the anesthetic agent of choice.

There is good reason for this move. Ketamine results in an altered state of consciousness and works to reduce pain. Its ease of administration and efficiency has made it an ideal anesthetic option for surgeries and more recently, mental health treatments.

But while medical professionals see the benefits of ketamine, they and their counsel frequently don’t pay attention to a liability downside. Current medical malpractice policies may not cover the use of ketamine at the facilities in which the medical professionals practice. Unknowingly, medical practices may face huge liability risks for using what has become a standard issue drug.

Too many medical professionals lose the practices they spent their entire lives building because they didn’t have the correct liability insurance in place. Ketamine – or more specifically the lack of malpractice coverage for it – has now become an unseen danger for doctors.

This may seem like a surprise. After all, ketamine is not a brand-new offering with unknown side effects. Ketamine’s timeline begins in the 1950s, when researchers at a lab in Detroit were searching for a new anesthetic agent with analgesic properties. While not an instant success, research around the drug continued throughout the next decade, eventually resulting in its approval first as a veterinary anesthetic in 1963, and then in 1970 by the Food and Drug Administration (FDA) for human consumption. Following FDA approval, ketamine was used extensively as a surgical anesthetic for American soldiers during the Vietnam War. It proved to be so popular and safe that it became known as the “buddy drug” in Vietnam – every soldier carried an injectable syringe to administer in case of a severe injury.

Ketamine’s ease of administration, efficiency, and effectiveness in treating blood loss and shock, as well as its ability to provide quick pain relief, resulted in widespread enthusiasm for the drug’s revolutionary medical properties both on the battlefield and in hospitals across the country. The World Health Organization added it to the List of Essential Medicines in 1985

Ketamine Use in Hospitals and Medical Offices

Ketamine has been used in the operating room for over 50 years, in the United States and around the world, with remarkable success. As it does not reduce a patient’s heart rate, breathing rate, or blood pressure, it is considered one of the safest anesthetics to use before, during, and after surgery. In current medical practice, ketamine is used in a wide variety of applications including general pain relief, cardiac catheterization, skin grafts, endoscopies, and other minor surgical interventions.

For doctors, especially surgeons and anesthesiologists, ketamine is critical to modern-day healthcare. It is one of the only drugs used in clinical practice that produces hypnotic, analgesic, and amnesic effects at the same time. Since it does not require refrigeration or any special preparation, it is especially beneficial for medical care in the field and in developing countries.

Ketamine Use for Mental Health

In addition to its use in anesthesia, ketamine has been gaining ground as a promising alternative treatment for medication-resistant mental health disorders. While other treatments can take weeks or even months to take effect, ketamine has been found to provide quick symptom relief to people who respond to it. Research around ketamine for mental health use began in the early 2000s and continues today; as more is discovered about the way the drug works, new applications for the drug are proposed. It has been referred to as the “new wonder drug” for the treatment of major depression.

With increasing numbers of mental health professionals recognizing the medical benefits of ketamine, the treatment is now more widely available than ever before. From 2015 to 2018 alone, the number of clinics across the country specializing in ketamine infusions grew from 60 to 300.

Two main types of ketamine are currently used to treat major depression: IV Ketamine, which is used off-label, and Esketamine (Spravato), which is administered as a nasal spray. Doctors are continually learning about ketamine’s many properties and speculate that ketamine infusions may help treat anxiety, bipolar disorder, alcoholism, post-traumatic stress disorder (PTSD), and other mental health disorders.

Still, while the numerous benefits of the drug continue to be explored, ketamine is not without its controversies. And here is where medical providers run into malpractice issues.

The Problems with Ketamine

In the popular mindset, ketamine is not seen as a miraculous way to treat injuries or depression. Instead, it has a more lurid connection. After the Vietnam War, recreational ketamine abuse grew. It became a popular club drug, which resulted in ketamine’s placement among the Class III substances of the federal Controlled Substances Act in 1999. Users report an out-of-body experience and feelings of detachment from themselves and their surroundings. The result is potentially dangerous, with even a small amount sometimes leading to overdose, especially if other drugs or alcohol have also been ingested. Despite ketamine being noted medically as having some beneficial effects on the respiratory system, respiratory failure is the leading cause of death from a ketamine overdose. Furthermore, ketamine is considered one of the three most common date rape drugs.

With its potential for abuse as a street drug, coupled with a heightened awareness of the consequences of substance dependence from the opioid crisis, many people remain skeptical of the validity of using ketamine to treat various conditions. Yet despite its negative connotations, mental health professionals continue to move forward with research and new areas of use, claiming the benefits of the drug outweigh the risks.

The Challenges of Mixing Off-Label Prescriptions and Medical Malpractice Insurance

It's clear that ketamine use in medical settings is on the rise. Helping this along is a recent trend in the law to allow greater use of off-label treatments. A study showed that 31 percent of prescriptions in general office-based practices were given for off-label use.  This total rises for psychiatric care, which has seen levels as high as “40 to 80 percent of recipients of commonly prescribed psychotropic medications…. receiving these medications for off-label indications.”

However, getting malpractice insurance for an off-label treatment of a controlled substance has proven to be a significant hurdle for the field. Moreover, despite its rise in popularity, ketamine is generally not covered by malpractice insurance for its off-label treatments for depression and other psychiatric disorders

In recent years, ketamine infusion clinics have opened up throughout the country by practitioners of all types and some without psychiatrists on site. These provide off-label use of ketamine and some claim that they provide their own “proprietary blends” in order to get the maximum effect.

As ketamine has side effects, including agitation and respiratory issues, its increased use may invariably lead to an increase in lawsuits against those who prescribe or administer it. This risk may be greater with off-label use, due to, among other things, the lack of dosing guidelines and safety issues, such as heart rate elevations.

A poor result with these medications can leave providers at risk of being sued.  Generally, as with other medical prescription cases, the concerns would be focused on negligence of one or more types, often paired with a lack of informed consent. Informed consent grows out of the patients’ right to control their treatment, and patients need to have a clear understanding of the care they are receiving and the potential setbacks that could come out of it.

Law enforcement and first responders are beginning to get sued for their use of ketamine in non-medical settings. For instance, the state of Colorado has been sued by several people who claim they were harmed from injections of ketamine, which police officers and other first responders use to treat extreme agitation at the scene. Similarly, in South Carolina a woman recently filed a lawsuit against Charleston County emergency medical services (EMS)  when her husband died after being injected with Ketamine during an arrest.

And now at least one lawsuit has been filed against providers for the off-label use of ketamine. An Oregon man has sued his pharmacy and ketamine prescriber for $8.2 million when he experienced a dissociative episode and attacked his wife after using the drug. The suit claims several counts of negligence, including prescribing it for a use that was not approved, failing to administer test doses in a monitored medical setting, excessive dosing, failing to warn the plaintiff of potential side effects, and failing to warn him that it was an off-label use.

These cases, along with the exploding popularity of off-label ketamine use, may suggest that providers could face an increase in lawsuits in the coming years.

Informed consent may end up playing a major role in these cases. Physicians are responsible for providing the information in order for patients to make their own decisions. Informed consent does not just mean a signed consent form, though that is obviously highly recommended. Physicians and other providers should make sure that patients understand the risks of ketamine. Understanding and effectively communicating off-label risks is inherently a challenging issue for medical practitioners, and the potential ramifications of failing to ensure consent fall entirely on them.

In addition to the risk of malpractice suits, in extreme cases, professional misconduct charges can result from off-label prescribing. A recent paper in the Journal of American Academy of Psychiatry and the Law noted that: “While trends in jurisprudence appear to be favoring clinicians’ freedom to promote prescription medication for any use, in a majority of jurisdictions, the U.S. government can still bring considerable weight to bear on clinicians promoting off-label uses of prescription medications.” The authors also noted: “While the practice of off-label prescription of FDA-approved medications is common and often medically beneficial to patients, the promotion of such uses places physicians at heightened risk.

Implications for Providers

Ketamine has proven to be a wonder drug in the past, and as it evolves, it may provide immense help with mental health issues.  But doctors and other healthcare providers without the right liability policies in place leave themselves open to enormous risk of a ketamine-related lawsuit. Surgeons, Ketamine infusion clinics, and other providers and their counsel need to proactively reach out to their insurance provider to ask if ketamine administration is covered under their current malpractice policy. Such policies are available, but there is a need to be certain that one is protected, especially if prescribing ketamine for off-label use. If not, it's time for providers to review their options. As providers seek new ways to use ketamine to help and protect their patients, they should do so cautiously and make sure they are also protecting themselves and their practices.

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    Max Schloemann, Carbondale, IL

    MEDPLI Insurance Services

    Max Schloemann is the founder and CEO of MEDPLI Insurance Services.  Serving doctors in the United States since 2008, Mr. Schloemann is committed to helping surgeons and other physicians get the best protection for their private practices, 1099 contract jobs, and tail coverage. Mr. Schloemann is a guest speaker at SIU School of Medicine, and has collaborated with health lawyers to provide practical tips on malpractice insurance, risk management, and the importance of informed consent.  He can be reached at 800-969-1339 or [email protected]