A Utah pilot program allowing AI to autonomously renew prescriptions is raising clinical and legal concerns, according to a perspective piece published April 23 in the New England Journal of Medicine.
Launched in January, the program uses an AI system developed by Doctronic to renew prescriptions for patients with chronic conditions after physicians review the first 250 cases. The system then operates without oversight of individual decisions and is limited to 192 commonly prescribed drugs.
The authors said the model may be appropriate only for select patients with stable, predictable conditions. They warned it may miss changes in clinical status for medications requiring close monitoring, such as levothyroxine and sacubitril-valsartan, and could reduce opportunities to address polypharmacy and medication overuse.
The analysis also raises questions about regulatory compliance. The authors said the tool could qualify as a medical device under the Federal Food, Drug, and Cosmetic Act and may require FDA review, which has not occurred. They also questioned whether AI can meet requirements that prescriptions be authorized by a licensed practitioner.
While medication adherence remains a major challenge — affecting 40% to 60% of patients with chronic disease — the authors said automated refills alone do not address key barriers such as cost, side effects and health literacy.
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