A red herring in the complex case of radiopharm access?

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.

NRC regulations require that an authorized user (AU) be certified by a medical specialty board recognized by either the NRC or an agreement state or have completed 700 hours of T&E in “basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material requiring a written directive” (10 CFR 35.390(b)). In recent years, the NRC has been under pressure to reduce the T&E requirements for radiopharmaceuticals through the “alternate pathway,” based on concerns about limited access to certain radiopharmaceuticals driven by a perceived shortage of AUs. The NRC’s Advisory Committee on the Medical Use of Isotopes (ACMUI), on which several radiation oncologists and medical physicists serve, formed a permanent subcommittee to look at these requirements and make suggestions for changes, if warranted. The subcommittee is expected to finish its work on this section by ACMUI’s fall 2018 meeting. If the NRC decides to make changes to the requirements, those changes will have to go through the rule making process.

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 cindy.tomlinson@astro.org.

Dr. Beyer serves on ASTRO’s Board of Directors and practices in Sedona, AZ.
Posted: July 10, 2018 | with 0 comments

Blog post currently doesn't have any comments.
 Security code