Picture this potential scenario: An injured worker is struggling with both physical pain and the psychological aftermath of a workplace accident. Their healthcare provider suggests compounded ketamine as a potential solution for their mental health challenges. Now the prescription has come to your desk to review.
This scenario has become increasingly relevant following an FDA alert specifically addressing compounded ketamine use in psychiatric treatment. The regulatory body expressed concerns about potential dangers when these products are administered without proper medical supervision – a warning that has significant implications for workplace safety and recovery management in compensation cases.
As the workers’ compensation landscape continues to evolve, new treatment approaches emerge regularly – some with more evidence behind them than others. Compounded ketamine products have entered this arena with serious questions about their safety and appropriateness in treating recovering employees.
Ketamine: An Unapproved Medication for Psychiatric Disorders
Ketamine has had quite the journey – from operating rooms to veterinary clinics to street corners to psychiatric treatment centers. Originally developed as an anesthetic, ketamine has long been a staple in veterinary medicine where it serves as a crucial anesthetic and analgesic for everything from routine procedures to emergency surgeries across various animal species. Its safety profile and effectiveness in veterinary settings are well-established with protocols refined over decades of clinical use.
In fact, veterinary clinics face unique security challenges precisely because of ketamine’s legitimate value in animal medicine. The Drug Enforcement Administration (DEA) classifies ketamine as a Schedule III controlled substance, and veterinary practices must implement strict inventory controls and security measures to prevent diversion. Despite these precautions, veterinary clinics have unfortunately become targets for break-ins and thefts specifically aimed at obtaining ketamine for illicit purposes.
But here’s the kicker that many don’t realize when it comes to human psychiatric applications: The FDA has never approved ketamine for treating any psychiatric disorder nor has it approved compounded medications. The FDA has only approved Ketamine as an anesthetic. In fact, it was first used in the Vietnam war as a battlefield anesthetic, and always under the supervision of medical professionals. Despite these crucial facts, ketamine products (including compounded routes of administration) continue to be prescribed for conditions found in workers’ compensation claims like depression, anxiety and PTSD.
While a related compound, Spravato (esketamine) nasal spray, received FDA approval in 2019 for specific depressive conditions, this is fundamentally different from compounded ketamine. Spravato contains only one molecular component of ketamine and follows strict protocols that compounded ketamine products do not. Spravato is also part of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) that requires Spravato (esketamine) to be “dispensed and administered in health care settings that are certified in the REMS. Patients must be monitored inside the healthcare setting after administration for a minimum of two hours until patients are safe to leave.”
Compounded ketamine in both pill form or when taken sublingually is not part of the REMS program nor approved by the FDA for any indication. The disconnect between regulatory approval and real-world use creates challenges for workers’ compensation stakeholders. Consider these facts about compounded ketamine:
- These products haven’t undergone the rigorous FDA evaluation process for safety, effectiveness, or quality.
- Dosage standardization in compounding presents significant challenges, resulting in inconsistent concentrations that make precise patient dosing difficult to achieve.
- Without proper healthcare monitoring, patients face substantial risks that could complicate recovery.
- The potential side effects include abuse potential, psychiatric complications, blood pressure spikes, respiratory depression, and urinary tract issues.
The tragic death of actor Matthew Perry in October 2023 serves as a sobering reminder of ketamine’s potential dangers. The beloved “Friends” star died from “acute effects of ketamine,” according to the Los Angeles County Medical Examiner. While Perry had reportedly been receiving ketamine infusion therapy for depression and anxiety, investigators determined the level of ketamine in his system at time of death was in the range used for general anesthesia during surgery. This high-profile case underscores the critical importance of proper medical supervision, appropriate dosing, and the serious risks associated with this powerful substance—whether obtained through legitimate or illicit channels.
What This Means for Workers’ Comp Programs
For industry professionals navigating the already-complex world of workers’ compensation, compounded ketamine adds another layer of complexity. Here’s what you need to know:
The Claims Red Flag
Unlike standard, FDA-approved medications with established protocols, ketamine compounds exist in a gray area – with uncertain dosing standards, unproven efficacy for mental health conditions, and potential complications that could extend disability duration.
The Workplace Safety Wildcard
What happens when a recovering worker returns to duty while using compounded ketamine? The sedation, dissociation, and cognitive effects could transform even routine tasks into safety hazards. For workers operating machinery, driving company vehicles, or working at heights, these effects could be catastrophic – potentially leading to secondary injuries and claims.
The Return-to-Work Roadblock
The monitoring requirements for ketamine don’t mesh well with typical return-to-work timelines. Compounded ketamine lacks standardized safety measures found in REMS drugs, introducing variables that complicate return-to-work planning.
Smart Strategies for Forward-Thinking Claims Teams
A strategic approach to reviewing all ketamine-related treatments includes:
- Knowing the Red Flags: It’s important to identify compounded ketamine prescriptions early in the claims process.
- Ask the Right Questions: When ketamine is proposed, initiate a dialogue: Has the prescriber explored FDA-approved alternatives? What monitoring protocols will be in place? How will workplace safety be addressed?
- Develop a Ketamine Protocol: Create a specialized clinical review process specifically for these prescriptions, bringing in your PBM partner’s expertise.
- Collaborate on Safety Planning: When ketamine treatment proceeds, implement appropriate safeguards – from modified duties to specialized supervision.
The Bottom Line: Balancing Innovation and Caution
The mental health aspects of workplace injuries deserve serious attention and effective treatment. However, recent FDA warnings remind us that evidence must guide our decisions. At Preferred Medical, we advocate for treatment approaches backed by rigorous science and regulatory approval. When claims involving compounded ketamine appear, they merit specialized review that considers both the individual worker’s needs and the employer’s safety obligations.
This blog post is intended for informational purposes only and does not constitute medical or legal advice. For specific guidance on individual claims or cases, please consult with appropriate clinical and legal professionals.