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Don’t Let Non-Docs Give Radiopharmaceuticals, AMA Says

CHICAGO — The federal government shouldn’t allow non-physicians to prescribe and administer radiopharmaceutical treatments, members of the American Medical Association (AMA) said at their annual House of Delegates meeting.

“Physicians are the only ones trained in monitoring the side effects of using radioisotopes for clinical care for our patients,” said Anupriya Dayal, MD, a radiation oncologist from Jenkintown, Pennsylvania, who spoke on behalf of the American College of Radiation Oncology.

Speakers were responding to a resolution from the AMA’s Residents and Fellows Section that urges the AMA to “advocate for a follow-up review by the Institute of Medicine of the Nuclear Regulatory Commission’s medical use program, specifically evaluating effects of the Nuclear Regulatory Commission’s (NRC) regulatory policy in the last 25 years on the current state of nuclear medicine in the U.S. and patients’ access to care.”

The resolution notes that the NRC recently published a proposed rule that would reduce the training and experience requirements for use of therapeutic radiopharmaceuticals and allow for non-physicians to administer them; the rule’s comment period — which originally ended on June 3 — was recently extended to July 3.

“I’m worried this could affect safety for patients,” said Ankit Agarwal, MD, a radiation oncology resident from Chapel Hill, North Carolina, and a delegate for the American Society for Radiation Oncology (ASTRO). “This is an issue that the AMA needs to act now to protect the practice of medicine so doctors can prescribe radiopharmaceuticals.”

The reference committee that considered the resolution recommended that it be referred back to the AMA Board of Trustees for a decision. But Alan Klitzke, MD, of Buffalo, New York, a delegate for the American College of Nuclear Medicine, argued against referral, noting that he had a simpler amendment he wanted to introduce instead. “The original resolution may have been a little more encompassing and cumbersome than what we really need,” he said. “The main issue is that the NRC, with pressure from industry, wants to reduce requirements for authorized users of radiopharmaceuticals.”

Steven Huang, MD, of Los Angeles, a delegate for the California Medical Association who was speaking for the PacWest coalition, agreed with Klitzke. “We believe that any reduction in current treatment requirements will compromise safety for patients, caregivers, and family members,” he said, adding that since there is no shortage of treatment providers in this area, “there is no reason for a change in current training requirements.”

But Rodney Trytko, MD, who chaired the reference committee, disagreed. “This is an extremely complicated issue and is certainly beyond the expertise of anybody on the reference committee,” he said. “The only possible path to get the authors what they’re requesting is a referral for decision.”

House of Delegates members ended up siding with Klitzke and voting against referring the matter to the Board of Trustees. Klitzke then immediately introduced his substitute amendment, which called on the AMA to oppose the proposed rule and submit a comment by the July 3 deadline. The amendment was adopted on a voice vote.

In other developments, the House of Delegates also:

  • Referred to the Board of Trustees a reference committee report calling for the FDA to monitor the professional activities of former FDA advisory committee members to see whether they make any professional moves after they leave the committee that could be construed as “pay-later” conflicts of interest, and to consider formulating policies to address the issue.
  • Urged the AMA to push for a change in the federal Open Payments database of payments to physicians from industry that would allow disputed payments to be removed from a physician’s record if the physician can show that the payment was wrongfully included.
  • Voted to keep AMA membership dues at the same level. Dues, which haven’t changed since 1994, range from a low of $20 for medical students up to a high of $420 for regular members; discounted membership categories include retired physicians and those in military service.

The House of Delegates meeting wrapped up Wednesday morning. The delegates will next meet in November in San Diego.