David Beyer, MD, FASTRO, is Immediate Past Chair of ASTRO's Board of Directors
By David Beyer, MD, FASTRO, ASTRO Immediate Past Chair
Concerning potential changes to training and experience (T&E) requirements were again on the agenda when I met with Commissioners of the Nuclear Regulatory Commission (NRC) on June 26 to discuss radiation oncology’s priorities.
ASTRO meets annually with Commissioners, and we have frequent interaction with NRC staff. We always appreciate the opportunity to strengthen our relationship with this critical agency that must balance safety and access to radioactive isotopes in medicine. As she does every year, Cindy Tomlinson, ASTRO’s senior patient safety and regulatory affairs manager, joined me in these meetings with NRC Chairman Christine Svinicki and Commissioners Jeff Baran and Annie Caputo, who was recently confirmed by the U.S. Senate. We had positive conversations about safety culture, medical event reporting, supervision requirements, and T&E requirements for radiopharmaceuticals, which has been a hot topic for the agency.
It is difficult to determine whether there is an actual or perceived shortage of AUs. The American Board of Radiology (ABR) estimates that between 2007 and 2017, approximately 1,650 radiation oncologists were certified by the ABR with an Authorized User Eligibility designation and may become AUs. In addition, ASTRO estimates that there are approximately 2,200 radiation oncology facilities in the United States, which means beyond the nuclear medicine-trained AUs nationwide, there are likely enough AUs just among the radiation oncologists to administer radiopharmaceuticals.
ASTRO’s Government Relations and Health Policy leadership believes that what’s at play with the utilization of radiopharmaceuticals is a much more complicated mix of economic and practical factors. Other factors impacting use likely include changing referral patterns and comparable alternative treatment options – neither of which involve the number of AUs available to administer these treatments. Changing the T&E requirements could be a red herring and might compromise safety without addressing the multifactorial issues.
In our meetings with the Commissioners, we reiterated that the current 700-hour requirement is appropriate, protects the safety of patients, the public, and practitioners, and should not be lowered. The rigorous T&E requirements contribute to the excellent safety record of radiopharmaceuticals. Further, ASTRO believes that it is important that the person administering the radiopharmaceutical is appropriately trained in the safe handling, exposure risks, and the management of side effects of radiation.
Still, this is a challenging issue that requires our attention. During our meetings with the Commissioners, we were asked what an ideal training program would look like for those seeking AU status under the alternate pathway. Would an ideal training program mirror existing radiation oncology and nuclear medicine training programs and curriculum? Or, would a program contain different requirements, and if so, what would those requirements be? Or, would the requirements remain at 700 hours without a specific curriculum?
As theranostics and other novel therapies emerge, these questions will only grow in importance, and we’re looking for ASTRO member input on this important topic. Tell us what you think by commenting below or contacting Cindy Tomlinson at email@example.com.
Dr. Beyer serves on ASTRO’s Board of Directors and practices in Sedona, AZ.