Prepare for Liability Risk with Ketamine Assisted Psychotherapy Protocols

Ketamine assisted psychotherapy (KAP) is an emerging mental health treatment that presents unique risks. Understanding those risks and implementing policies and procedures within your practice is essential to providing safe patient care in a way that protects you from undue malpractice risk. This article outlines potential liabilities and offers suggestions to reduce those risks.  

What Would a Lawsuit Look Like Involving Ketamine Assisted Psychotherapy? 

As a KAP prescriber your patient’s lawyer may file a lawsuit claiming that you were negligent and should be liable for malpractice. To win the case, the patient’s lawyer must prove to a jury the same four elements that they would have to prove in any medical professional liability case. 

These are the elements and how they might apply to a real-life example.  

• Element 1: You had a duty to treat the patient. 

• • Jim, who suffers from treatment resistant depression, schedules an initial appointment with Ms. Vance, a psychiatric nurse practitioner, to determine if he is a good candidate for KAP. Based on her visit with Jim, she accepts him into the practice and explains the risks and benefits of and alternatives to KAP. Ms. Vance determines that Jim is a good candidate for in-office IV ketamine. Ms. Vance discusses a treatment plan with him, and Jim decides to move forward. She establishes a treatment relationship with Jim and now has a duty to provide care. 

• Element 2: There was a breach in the duty of care because treatment did not comply with the standard of care. The standard of care is defined as the degree of care, skill, and learning expected of a reasonable and prudent health care provider acting in the same or similar circumstances. Each party must hire an expert witness who will testify that the provider either did or did not meet the standard of care. 

• • Ms. Vance treats Jim for three months and he does not report any side effects such as nausea and dizziness.  
    
    
  • At Jim’s most recent office visit he briefly reports to a medical assistant that he sometimes feels dizzy upon standing but brushes it off as unrelated.  
    
    
  • On his way out of the office, Jim loses his balance, falls, and hits his head on the floor. He immediately stands up, expresses embarrassment, and assures the staff that he is alright, and it is no one’s fault that he fell. 
    
    
  • Nonetheless, he might later allege that Ms. Vance did not meet the standard of care when she allowed him to stand up on his own and walk out of the office without an escort because dizziness is a known potential side effect. He may claim that the standard of care dictates that he should have been monitored for a longer period of time and escorted in a wheelchair to his ride. 

• Element 3: The breach caused an injury to the patient. 

• • Jim later learns he has a severe concussion because of the impact of the fall at Ms. Vance’s office. Despite his assurances to office staff that the fall was no one’s fault, he could allege in a lawsuit that the breach caused his head injury. 

• Element 4: The patient suffered actual injury or damages (e.g., pain and suffering, loss of income, costs of additional treatment, etc.). For example:

• • Jim needs treatment for his head injury and has medical bills his health insurance plan will not cover.  
    
    
  • He suffers from fatigue, mild confusion, and headaches and, for now, cannot safely perform his work as an industrial engineer. He has long term disability insurance that only replaces two-thirds of his entire salary for the next several months and he needs his full salary for mortgage, school loan, and car payments.  

Despite Jim’s insistence that the fall was nobody’s fault, he becomes increasingly resentful that the practice did not escort him to the car and contacts a plaintiffs’ attorney who agrees to take the case. Jim’s lawyer serves Ms. Vance with a lawsuit. She promptly calls the MICA Claim Department to report the case and her Claim Representative assigns an attorney to defend her. 

It is challenging for Ms. Vance’s attorney to find a KAP provider willing to testify on her behalf. Given the novelty of KAP, establishing a standard of care may be difficult while the treatment is in an early stage of use. There are only a few nurse practitioners prescribing and monitoring KAP and they may not yet agree on standard practices for prescribing and discharging patients after a session. Even if both parties secure expert witnesses, it is still up to a jury to decide which expert to believe and if Ms. Vance met the standard of care. 

Understand the Risks and Take Steps to Reduce Your Exposure 

Jim’s case is only one example of a potential risk of prescribing and monitoring KAP. As a licensed practitioner providing KAP, you must have a thorough understanding of the patient safety risks and ways to limit the potential for harm as KAP evolves.  

Prescribers and their practices should consider the following while developing policies and procedures in anticipation of offering KAP. 

• Pre-session screening 

• • KAP is not right for every patient, and you should have written patient selection criteria to ensure that the potential benefits outweigh the risks. Whether you believe the patient to be a suitable candidate or poor candidate, always keep detailed records of your pre-session screening, including an explanation of your rationale for recommending or not recommending KAP.  

• Informed Consent 

• • Most treatments bear some risk, even if it seems that the patient has a low chance of experiencing any adverse effects. If you determine the patient is a good candidate for KAP, make sure to explain the risks and benefits of and alternatives to KAP and document the details of your informed consent conversation. Give patients a written informed consent document that also explains the same risks, benefits, and alternatives; ask them to sign it; give patients a copy; and put the original signed document in their medical records. 

• Patient Monitoring 

• Prescribers should consider the way ketamine will be administered and the treatment setting when deciding on the level of monitoring to detect signs of sedation, respiratory depression, and dissociation. 

• Here is just some of the information available about routes and settings. 

• • Intranasal ketamine administration 

• • • Spravato esketamine nasal spray is the only form of ketamine approved by the FDA for KAP. The FDA’s approval requires the use of Spravato in conjunction with an anti-depressant for treatment-resistant depression and administration under the direct supervision of a health care provider.
        
    • The Spravato boxed warning and the federal Risk Evaluation and Mitigation Strategy (REMS)  contain many warnings including monitoring patients for changes in blood pressure and respiratory status (including the use of pulse oximetry) for 2 hours after administration. 

• • Intravenous administration 

• • • Prescribers and staff should be certified to initiate and follow the American Heart Association’s advanced cardiac life support (ACLS) protocols. 
       
    • Other interventions may include antihypertensive medications, basic cardiac life support or cardiopulmonary resuscitation, use of an automatic external defibrillator, oral airway devices, oxygen, and/or bag-masking.  
      
      
    • Patient rescue plans should include activation of emergency medical systems, especially if the patient requires a higher level of care than can be provided in the office, practice, infusion center, etc. 

• • Oral and intramuscular ketamine administration 

• • • Before offering KAP, prescribers should collect and maintain a file of articles, research, data, and other clinical support for the rescue plan and the level of emergency care they will provide.  
      
      
    • While oral ketamine may seem less risky, a rescue plan for oral KAP may include the same protocols, interventions, equipment, and emergency medical systems as rescue plans for IV ketamine, especially when used with patients at higher risk for cardiac or pulmonary demise or arrest.  
      
      
• Prescriber Training and Competence  

• • Prescribers should determine, achieve, and maintain the education, training, and experience needed for safe and effective KAP.  
    
    
  • KAP is an evolving therapy so prescribers should keep up with the research and periodically revise their policies and procedures to reflect reasonable and prudent care at any given time. 
    
    
  • Prescribers should keep a file of the peer-reviewed articles, research, and data they considered while developing their KAP treatment protocol. The file is an easy-to-access internal resource and assists your defense attorney in the event of a malpractice claim.  

• Staff Qualifications 
  • Prescribers may not be able to delegate the administration or monitoring of ketamine to medical assistants. Prescribers should check state laws and regulations and ensure they are delegating administration or monitoring to staff members with the appropriate education, training, licensure or certification, and experience. 
    
    
  • MICA recommends that prescribers consult their business or health care attorney to review policies and procedures and determine if they are appropriately delegating administration and monitoring. 

KAP may help some patients with severe mental health symptoms but do not let the excitement about the therapy overtake your focus on reasonable and prudent care. Ketamine is a powerful anesthetic and should be prescribed for other purposes, such as KAP, after careful consideration of the related research and patient studies and in compliance with policies and procedures that represent your and your staff’s education, training, experience, capacity, and licensure/certification along with the laws of the state where you practice. 

If you have questions about preparing your medical practice for malpractice risks with ketamine assisted psychotherapy, our Risk Team is available to answer your questions. You can reach a Risk Consultant Monday – Friday 8:30am – 5pm MST at 800-352-0402 x 2137, 602-808-2137, or rm_info@micainsurance.com.