Comment from Stephen Szabadi, MD
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Summary: A psychiatry resident argues that automated risk stratification tools for controlled substances currently lack sufficient oversight and evidence of efficacy. They support the petition's call for a formal FDA review process to ensure these tools meet safety and quality standards before continued clinical use.
Automated risk stratification tools for controlled substance prescribing have tremendous capacity to cause inadvertent harm. The tools mentioned in this document are already widely adopted and see clinical use. As a psychiatry resident, I can attest that they are given considerable weight in clinical decisions by many providers, even though the information provided by said tools are only meant to be used as a ‘decision-support tool’. In order to meet the spirit of FDA’s legislative mandate to the American public, these tools must pass the muster of a formal review process and show quality evidence of efficacy before being allowed continued use.