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2026 FSA Podium and Poster Abstracts

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DP11: PATIENT SAFETY AND REGULATORY TRANSPARENCY ON OUTPATIENT KETAMINE CLINIC WEBSITES IN SOUTH FLORIDA: A CROSS-SECTIONAL AUDIT
Beatriz De Faria Sousa, BS1; Jhon Ostanin, BA1; Helena Miranda, BS2; Lina Augius1
1Florida International University Herbert Wertheim College of Medicine; 2Florida Atlantic University Charles E. Schmidt College of Medicine

Background: Ketamine is a dissociative anesthetic and Schedule III controlled substance with well-described cardiovascular, neuropsychiatric, and abuse-related risks that require structured monitoring and clear patient counseling. In recent years, outpatient ketamine clinics have expanded rapidly across the United States, particularly for psychiatric indications, including off-label intravenous (IV) administration. However, direct-to-consumer online advertising for ketamine-based treatments remains largely unregulated. Prior analyses from other regions demonstrate inconsistent disclosure of ketamine’s risks and regulatory status, yet South Florida, one of the nation’s densest ketamine clinic markets, has not been evaluated. Accurate and transparent safety communication is essential to support informed consent, particularly when anesthetic agents with known physiologic and misuse risks are administered outside traditional perioperative settings. This study aimed to assess the completeness and accuracy of risk, safety, and regulatory disclosures on ketamine clinic websites in Miami-Dade and Broward counties.

Methods: We conducted a cross-sectional content analysis of ketamine clinics operating in Miami-Dade and Broward counties identified through targeted internet searches. Inclusion criteria required the presence of a functional clinic website containing clinical or marketing information; clinics without websites or with nonfunctional sites were excluded. Clinics were categorized as: (1) IV-only ketamine (off-label), (2) esketamine-only (FDA-approved), or (3) mixed. A standardized coding instrument evaluated website disclosure of: (a) addiction/misuse potential, (b) common adverse effects, (c) monitoring and safety precautions, (d) post-treatment driving-impairment warnings, (e) off-label status of IV ketamine, (f) misleading or false claims of FDA approval, and (g) presence of a licensed medical professional. Descriptive statistics summarized disclosure patterns across modalities.

Results: Twenty-two clinics met inclusion (9 IV-only, 6 esketamine-only, 7 mixed). Major gaps in safety communication were observed. Almost two-thirds (63.6%) did not mention ketamine’s misuse/addiction potential; 40.9% omitted adverse effects; 22.7% failed to mention safety precautions; and 50% provided no driving-impairment warning. Among clinics providing off-label ketamine (16/22), 68.8% failed to disclose their non-FDA-approved status. Misleading implications of FDA approval occurred in 13.6% of websites, with some of them characterizing ketamine as “non-addictive.” County-level differences were also notable: Broward County clinics demonstrated more complete safety communication overall, particularly regarding post-treatment safety precautions (88.9% vs. 69.2% in Miami-Dade) and presence of monitoring procedures. Modality-specific patterns emerged in both counties: esketamine-only clinics consistently reported addiction/misuse risk (50%), compared to 22.2% of IV-only clinics and 42.9% of mixed-modality clinics. In addition, 22.2% of IV-only clinics disclosed side effects on their websites, compared to 66.7% of esketamine-only clinics and 85.7% of mixed-modality clinics.

Conclusion: Ketamine clinic websites in South Florida frequently lack essential safety, risk, and regulatory information, and off-label IV ketamine services rarely disclose their regulatory status. These omissions may compromise informed consent and expose patients to preventable harm, especially given ketamine’s known abuse liability and expanding commercial use. Establishing minimum standards for online risk communication, through professional societies, local medical boards, or county-level guidance, represents a low-cost, high-impact opportunity to improve patient safety, strengthen ethical advertising practices, and support responsible implementation of both FDA-approved and off-label ketamine therapies.

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