Medical licensing board objects to Utah AI prescription refill experiment

Utah’s experiment in AI-generated primary-care prescription refills is raising some concern within the medical community.

At the center of the controversy is an agreement announced earlier this year between Utah’s Office of Artificial Intelligence Policy and an artificial intelligence health startup called Doctronic that allows AI to ask the patient a few questions and then renew prescriptions for close to 200 oft-prescribed medications. The drugs are those commonly used and needed long term, such as blood pressure medication, asthma inhalers, blood thinners and contraceptives.

The Utah agreement allows automation of “routine, guideline-based prescription renewals for Utahns,” including 30-, 60- and 90-day refills of medications that were prescribed by a licensed provider.

Friday, the Utah Medical Licensing Board sent a letter to the Department of Commerce and the Office of Artificial Intelligence Policy complaining that the board was not consulted about the experiment and reporting that the agreement without that consultation “potentially places Utah citizens at risk and remains a major concern of the board.”

The letter urges “immediate” suspension of the program until it can be more thoroughly discussed.

Difference of opinion

There are both advocates and opponents of the experiment with AI prescription refills.

In the letter, the medical board said that although it supports “the legislative mandate to explore AI implementation, we also have a stewardship to protect Utah citizens. Collectively, the board has decades of medical experience across a variety of specialties, positioning us to understand the potential consequences of implementing what may seem like an innocuous task of AI-driven prescription refills.”

Oversight by a licensed medical practitioner is needed, per the letter, “for critical safety and clinical reasons. Each refill requires reassessment and clinical decision-making to safely adjust doses, monitor for side effects, contraindications or new drug interactions and ensure the medication remains effective.” Without that reassessment, the group warns, patients may “remain on outdated or suboptimal therapy for months or years.”

Others argue that it’s an efficient way to provide refills of drugs that have already been prescribed by a qualified medical professional. Automating the refill process for certain often-renewed drugs could improve access by simplifying the process.

As Leana S. Wen, as emergency room physician and clinical associate professor at George Washington University, wrote for The Washington Post, “Right now, getting a prescription refilled can be challenging. Many patients call a doctor’s office and struggle to reach the right person or are told it’s not possible without an in-person visit, which requires time and travel. Some end up putting off that visit and go without medications, which can be dangerous for those with chronic diseases such as hypertension, diabetes and cardiovascular issues.”

Per the Post, Doctronic co-founders Matt Pavelle and Adam Oskowitz said they excluded higher-risk drugs, such as opioids, stimulants and injectable medications.

If issues arise, the company said it has about 20 doctors who can be consulted. The questions asked by AI are designed to be the same ones a physician would ask before renewing a prescription.

Utah may help shape AI landscape

Telehealth.org reported Monday that the experiment is still Phase 1, “with no reported safety issues, as regulators continue to monitor performance and outcomes.” To move out of Phase 1, the system has to refill at least 250 prescriptions in all of the nine drug classes, which it has not yet done.

That article also noted that Utah “is expanding its AI sandbox model by adding a new behavioral health pilot with Legion Health to test AI-based prescription refills.” And it said that “Utah’s structured oversight approach is gaining national attention and may help shape future federal policy on AI in telehealth and clinical care.”

Telehealth.org notes that Utah is taking a structured oversight approach, letting companies test new tech under state supervision while those setting the rules evaluate how well the programs work, including safety.

Several states are starting their own similar experiments, while others are reportedly considering it.

Questions remain

KUTV reported that the Department of Commerce said board involvement was not required and that “licensed medical professionals were consulted before launch.”

But Wen noted there are "significant legal questions, including which entity should oversee such programs. Utah views AI-prescribing as part of the medical practice, which must be carried out by human clinicians, yet it has issued a waiver to allow the system to function without one. Meanwhile, the Food and Drug Administration has indicated that autonomous prescribing systems fall outside its regulatory scope, though some legal experts argue they should be treated like medical devices and held to the same rigorous standards."

Dr. Daniel Aaron, who is both physician and associate law professor at the University of Utah, told Wen that medical devices are required to show they are safe and effective before they can be deployed broadly.

“To have this incredibly novel use of a medical device without FDA saying a word is quite stunning and suggests that maybe we are going to see more untested products reach the market,” he said.