Legal Issues In Prescribing Ketamine for Depression
As with most new interventions, ketamine’s status as a treatment for depression lacks certainty within the law. Learn about how physicians prescribing ketamine can stay compliant.
As evidence builds demonstrating its effectiveness, more physicians are prescribing ketamine for patients struggling with mental illness. And with rates of anxiety and depressive disorder rising during the COVID pandemic, curiosity about the treatment has skyrocketed.
A Google search for nearby ketamine infusions may turn up Innovative Ketamine in Chicago, NY Ketamine Infusions in Manhattan, Mindscape Ketamine in Houston, or PointKetamine in Los Angeles. If you’re a cutting-edge mental health provider who isn’t offering ketamine therapy, you may worry that you’re already falling behind.
But physicians should prescribe ketamine with care. As with most new interventions, ketamine’s status lacks certainty within the law. Read on to learn how physicians prescribing ketamine can make sure they stay compliant.
Clinical Benefits of Ketamine.
Evidence suggests that ketamine treatment can rapidly reduce suicidal thoughts as well as feelings of depression and anxiety. While traditional talk therapy or antidepressant medicines often take weeks to months to take effect, ketamine offers many patients instant relief.
Ketamine affects glutamate, an abundant neurotransmitter that works with GABA to maintain a healthy nervous system. An imbalance between GABA and glutamate can cause anxiety, depression, and difficulties sleeping. Ketamine helps restore a healthy GABA-glutamate balance, and studies show that this increase in glutamate likely results in an antidepressant effect.
FDA Approval Status.
To understand the Food and Drug Administration’s (FDA’s) approved uses of ketamine, it’s helpful to review the basics of the FDA and how it approves new drugs or uses of existing drugs.
In 1938, Congress passed the Food, Drug, and Cosmetic Act (FDCA), the primary law that controls the FDA’s regulatory authority. It makes the FDA responsible for interpreting and enforcing its requirements. For example, one such requirement is that the FDA approves all new prescription drugs. To do this, the FDA implemented a rigorous drug approval process to determine which prescription drugs are safe for consumers.
The public became much more familiar with the basics of this process as we awaited an FDA-approved COVID-19 vaccine, but much more happens behind the scenes than we see on the evening news!
To introduce a new drug, the drug developer conducts laboratory and animal testing before submitting an application to the FDA. If the FDA approves that application, the drug company must then typically pass three phases of clinical trials:
- Phase I: The focus is on the drug’s safety. What are the drug’s most common adverse side effects?
- Phase II: The focus now is on the drug’s effectiveness. Will the drug help people who are suffering from a specific illness or condition?
- Phase III: Finally, the focus is to understand the drug in the context of how clinicians might use it. How does it interact with other drugs? How might it affect different patient populations?
If a drug clears these three phases, the FDA reviews the drug’s proposed labeling and convenes a formal meeting to review the clinical trial results. It is only then that the FDA will either approve the application or issue a formal letter explaining why the drug cannot proceed to market.
FDA Grants Approval For Specific Purposes.
The FDA approved the drug Tamiflu for the prevention and treatment of the influenza virus. However, it’s not approved for the prevention of tetanus or for the treatment of chickenpox. The FDA approves prescription drugs for specific illnesses and conditions. The FDA’s website provides a searchable database (Drugs@FDA Search) of all approved drugs, where consumers and prescribers can view a drug’s history, label, and approved uses.
However, a doctor can generally prescribe an approved drug for any illness or condition without specific approval, known as “off-label” use. For example, a doctor may prescribe an allergy medication to treat nausea or an oral contraceptive to treat acne.
Psychiatrists commonly prescribe medications off-label. For instance, the FDA has approved many drugs for adult use only. Nonetheless, doctors might prescribe them to children when they believe the benefits outweigh the risks. For many prescribers, the decision to prescribe a drug for off-label use may also depend upon whether the patient’s insurance will cover that off-label use. This varies by insurer, drug, and condition.
Ketamine and Off-Label Status.
The FDA approved ketamine, which is most often administered intravenously, for use as an anesthetic agent for surgical procedures. The FDA did not approve IV ketamine for any other indications.
However, in 2019, the FDA approved esketamine, a ketamine derivative, for treatment-resistant depression in adults. The designation “treatment-resistant depression” applies when at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode do not relieve the patient’s symptoms. Esketamine is commonly administered via a nasal spray.
Researchers continue to evaluate the relative efficacy of intravenous ketamine vs. intranasal esketamine for depression. Some evidence suggests that ketamine produces a greater overall response, and some physicians and patients simply prefer intravenous delivery. Thus, interest in the off-label use of ketamine continues to mount despite ketamine’s availability as an FDA-approved treatment.
Physicians expose themselves to liability daily — maybe hourly. Thus, when assessing an off-label use, they may ask:
- Is it riskier to prescribe this drug off-label or to not prescribe it at all?
- Have I exhausted all “traditional” treatment avenues?
- Even if it’s safe for adults, am I sure it’s safe for this child?
- How risky are the side effects?
Prescribing ketamine raises the same questions as any other drug. However, its rise in popularity and its reputation as a new “wonder drug” for treating depression has led more patients to ask for it and more practices to consider offering it to help their patients while boosting their bottom line.
When considering these competing interests — patient safety and practice financial health — physicians must also consider liability. The most common liability concerns typically relate to medical malpractice lawsuits or disciplinary actions by your medical board.
Ketamine and Medical Malpractice Risk.
Many physicians’ greatest fear is a medical malpractice lawsuit. A provider commits malpractice when they injure a patient either through a negligent act (e.g., leaving a sponge in the patient during surgery) or an omission (e.g., overlooking a tumor on a patient’s scan, resulting in a missed diagnosis). In these situations, the physician has violated the standard of care. In other words, they failed to do what a reasonably prudent physician would have done under similar circumstances and that this failure caused the patient injury.
Prescribing drugs for off-label uses can increase the risk of a medical malpractice suit because other providers may not have done the same. However, it’s also true that the FDA approval process is costly for drug companies. The cost barrier can dissuade drug companies from seeking FDA approvals even when additional safe uses are widely known.
Thorough documentation can reduce a physician’s risk in a malpractice lawsuit. Physicians should document the clinical evidence that informed their decision to prescribe ketamine. Through documentation, the physician can demonstrate that they used sound judgment.
Documentation should include the clinical factors that caused the physician to consider ketamine for the specific patient, a record that the patient gave their informed consent, and a record that the physician discussed alternative treatment options with the patient. Above all, physicians should only prescribe ketamine for an unapproved purpose when there is strong clinical evidence it will help the patient.
Ketamine and State Medical Boards.
Each state has a medical board responsible for regulating the medical profession. These state agencies investigate physicians to determine when their unprofessional conduct warrants a suspension or revocation of a license, an administrative fine, or another penalty.
Each state medical board defines unprofessional conduct differently. In general, though, unprofessional conduct is that which is likely to deceive or harm the public. Things that are likely to deceive or harm the public include violating the profession’s ethical standards, breaching a fiduciary duty owed to a patient, and failing to communicate with a patient appropriately.
Prescribing ketamine for an unapproved use may grab the attention of a board. As with medical malpractice, a board can use ketamine’s grey legal status to justify disciplinary action. For example, a board may determine that using ketamine to manage pain is unethical at high dosages. After an investigation, it can subject a physician to a license suspension for using it for this purpose. Again, documentation is critical. Physicians who justify their use of ketamine by maintaining a complete medical record are more likely to convince a medical board that their actions were appropriate.
Board action might also result from a lack of communication. Physicians are fiduciaries and have a heightened responsibility to provide competent care; their patients rely on their knowledge and expert advice. Ketamine use can cause cognitive or memory issues, vision problems, impaired motor function, seizures, irregular heartbeat, and other serious side effects. Moreover, long-term use of ketamine can result in psychological dependence.
Medical boards can discipline physicians who fail to discuss these risks thoroughly with patients, citing a breach of fiduciary duty. Therefore, physicians should inform patients about all the potential risks and benefits of ketamine for their treatment. During these conversations, physicians should explain that ketamine is only FDA-approved as an anesthetic and that the FDA considers any other use to be off-label.
DEA Violations: The Controlled Substances Act.
The Controlled Substances Act (CSA) regulates the manufacturing, importation, possession, use, and distribution of controlled substances. The Drug Enforcement Agency (DEA) is the primary agency tasked with enforcing the CSA.
The CSA classifies drugs into one of five categories depending on the drug’s ability to provide medical benefit and the potential for abuse. Schedule I drugs have the highest potential for abuse and no currently accepted medical use. These drugs are the most strictly regulated. Examples of Schedule I drugs are heroin, LSD, and, most controversially, marijuana. On the other end of the spectrum, Schedule V drugs are the least likely to be abused. Examples of Schedule V drugs are many cough suppressants and Lyrica.
The DEA classifies ketamine as a Schedule III drug. Drugs in this category have a lower potential for abuse than Schedule I and II drugs but a higher potential for abuse than Schedule IV and V drugs. In other words, a drug classified into Schedule III likely has some medical benefits and a moderate risk of abuse. Beyond ketamine, other examples of Schedule III drugs include codeine and Tylenol mixes and anabolic steroids.
Ketamine is still a Schedule III controlled substance even when a physician prescribes it off-label. As such, physicians must adhere to the CSA’s rules regarding ketamine registration, storage, distribution, and prescription protocols.
For example, physicians prescribing ketamine must follow the CSA’s prescription guidelines. Accordingly, all ketamine prescriptions must include the name and address of the patient, a manual signature of the prescriber, the name, address, and DEA registration number of the practitioner, and other specific information. Further, physicians must safely store their ketamine supply. The DEA recommends a wall-mountable controlled substance lockbox with two doors and two locks.
Meanwhile, many states restrict mid-level practitioners’ ability to prescribe Schedule III drugs. In Illinois, for example, neither chiropractors nor homeopathic physicians can prescribe ketamine.
Physicians who violate the CSA may face serious consequences. Penalties include the potential for civil penalties up to $250,000 or even criminal penalties, including jail time. The severity of the penalty is case-specific and will depend on the quantity of the ketamine involved and if the offender has any prior criminal convictions.
DEA Violations and the Ryan-Haight Act.
Congress created the Ryan-Haight Act in 2008 to regulate controlled substances prescribed via the internet. This law amended certain portions of the CSA.
Specifically, the Ryan-Haight Act prohibits any physician from prescribing ketamine without a valid prescription. A prescription is valid only when issued by a practitioner who has conducted at least one in-person evaluation.
Generally, then, physicians cannot prescribe ketamine during an initial telepsychiatry session. Instead, the patient must be in the physical presence of the practitioner before the physician issues the prescription. The responsibility for the proper prescribing and dispensing of controlled substances is on the prescribing practitioner.
Do note that the DEA declared a public health exception due to the COVID pandemic. Therefore, for the duration of the pandemic, physicians can prescribe ketamine without first conducting an in-person evaluation. To meet this exception:
- the prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of their professional practice;
- The telemedicine communication must be conducted using an audio-visual, real-time, two-way interactive communication system; and
- The practitioner must be acting in accordance with any other applicable federal and state laws.
The ability for physicians to avoid the in-person requirement is temporary. Once the pandemic ends, the exception ends. Although the Ryan-Haight Act does contain other exceptions, none of them are likely to apply to the typical telemedicine provider. Thus, physicians need to carefully evaluate their obligations under the law to avoid civil or criminal penalties.
Conclusion
Ultimately, physicians who want to prescribe ketamine must understand their legal risks. An experienced attorney can help make sure you stay compliant, allowing you to focus on caring for your patients. If you live in one of the states where Jackson LLP practices, book a free consultation to learn about how we can help your practice.
The COVID-19 pandemic is a dynamic and evolving public health emergency. The laws and situation are fluid, and this article may not reflect the most current situation.
This blog is made for educational purposes and is not intended to be specific legal advice to any particular person. It does not create an attorney-client relationship between our firm and the reader. It should not be used as a substitute for competent legal advice from a licensed attorney in your jurisdiction.