This statement is not meant to criticize Mr. Perry’s team of in-office practitioners, who seemingly treated him within the currently available regulatory guidelines and safety standards. We only mean to underscore how vital it is for the wider community of ketamine practitioners to fortify standards of care for patients with a history of substance abuse.
It is essential to acknowledge that there is a large evidence base of well-conducted research trials from major academic institutions supporting the safety and efficacy of ketamine, including for treating substance abuse. In addition, there is a severe mental health crisis, with rates of depression and suicide skyrocketing in recent years. Up to one-third of patients with depression are considered treatment-resistant. A legitimate need for more effective treatments exists, and it is imperative to balance the risks and benefits of ketamine therapy through clear standards and treatment guardrails so that this treatment can remain safe and accessible to patients who need it.
KEY STRATEGIES TO ASSESS AND MITIGATE AGAINST RISK OF KETAMINE ABUSE
Science and treatment innovation is moving faster than regulation, producing a significant regulatory void and considerable differences in the quality of care and the safety measures being taken in various clinics. Despite its potential in mental health, there is risk of abuse and misuse with ketamine. As such, careful consideration must be given when treating patients with a history of substance abuse.
- Patient Selection: Carefully selected, with attention to past and present substance abuse.
- Supervised Administration: A monitored medical setting with regular follow-up appointments to track response.
- Patient Education: A thorough discussion of treatment alternatives to manage expectations.
- Team Engagement: A diverse treatment group that includes a psychotherapist.
- Monitoring: Response, side-effects, and development of craving and desire for the treatment and/or other substances should be documented with potential use of urine toxicology monitoring in some circumstances
A detailed description of our society guidelines for careful and measured consideration when treating patients with a history of substance abuse can be found HERE.
CALLS-TO-ACTION
It is important to emphasize that ketamine is not considered to be physically addictive in the same way as opiates and alcohol, but rather psychologically addictive in some individuals. While craving for the drug in addiction may be notable, overt withdrawal syndromes, like those seen with alcohol, benzodiazepine and opioid dependence, do not occur with ketamine.
Mr. Perry’s situation, while not unique, was an outlier as compared to the average mental health patient without the influence and access to resources that can produce such ready access to excessive doses of ketamine. The vast majority of mental health patients will not have the means to access ketamine in such an extreme fashion, but safety looking forward is paramount. Today, the critical issues we must address are those that impact patients in the current evolving care climate, with its historic push towards mental health care innovation occurring outside of classical FDA-approval.
ASKP3 points to actions and solutions that can both ensure safety for the general public, while preserving access to this life-saving therapy, include:
- Adherence to Standards and Ethics: ASKP3 is engaged in urgent efforts towards developing cohesive community ethics and standards of care, to provide guardrails, appropriate protocols, and comprehensive risk assessment for treatment of mental health disorders, including substance abuse.
- Insurance coverage for ketamine therapy. ASKP3 calls for development of Prior Authorization Clauses that can help establish payment for off-label ketamine. Insurance reimbursement can help more people seek out in-office, medically-supervised treatment – the safest and most controlled environment for ketamine therapy – rather than unsupervised treatment at home.
- New FDA approved treatments: ASKP3 supports efforts to establish safety, efficacy and dosing ranges for ketamine and other NMDA receptor antagonists through FDA processes that can complement the large body of research supporting off-label treatments
Media Contact
Teresa Bigelow, ASKP3, 1 6462230402, [email protected]
SOURCE ASKP3
