Prioritizing Health and Radiation Safety in Radiopharmaceutical Therapy

wallnerThis post was contributed by Paul E. Wallner, DO, FACR, chair of the ad hoc workgroup on NRC training and experience requirements for the ACR Commission on Government Relations-Federal Regulatory Committee

The U.S. Nuclear Regulatory Commission (NRC) is exploring the idea of reducing training and experience (T&E) requirements for physicians authorized to use therapeutic radiopharmaceuticals regulated under 10 CFR Part 35, Subpart E (“Unsealed Byproduct Material—Written Directive Required”). The controversial concept would involve less comprehensive T&E pathways to authorized user (AU) eligibility for clinicians without the appropriate ABR, ABNM or AOBR board certification or the currently specified alternate pathway. The target audience would be referring clinicians who, for whatever reason, do not wish to refer their patients to the radiopharmaceutical therapy experts.

Supporters of weakened 10 CFR 35.390 AU T&E prerequisites—primarily commercial entities that manufacture or supply therapeutic radiopharmaceuticals—suggest there is a shortage of AUs, creating rural access problems. They argue that unitized dose delivery systems negate the need for physicians to have radiation and nuclear materials expertise. Such arguments are unsubstantiated, anecdotal and often conflicted.

With approximately a thousand trainees in the traditional pipelines of nuclear medicine, radiation oncology and nuclear/diagnostic radiology, demand for radionuclide therapy AUs under Subpart E will be adequately covered for the foreseeable future. With many considerations influencing treatment and referral decisions, it is unlikely that expanding the AU population with inadequately-trained clinicians would create additional points of access in rural areas. Rather, it is more likely that large facilities already licensed by NRC or the Agreement States for these uses would be disrupted internally. This concept would circumvent radiation best practices and cancer care standards while fostering an environment of financially-motivated utilization, thereby reducing the quality and safety of radiopharmaceutical therapy.

As a member of ACR’s Federal Regulatory Committee (FRC), I have chaired an ad hoc workgroup responsible for leading the College’s response. The workgroup consists of leaders and volunteers from ACR’s Commission on Government Relations, Commission on Radiation Oncology, Commission on Nuclear Medicine and Molecular Imaging, and Commission on Medical Physics-Government Relations Committee. Over the past year, we provided testimony to NRC’s federal advisory committee, wrote letters to NRC staff and leaders, collaborated with likeminded professional organizations, and met face-to-face with NRC’s Commissioners to educate them about our community’s concerns.

On January 29, 2019, ACR submitted public comments answering specified questions from NRC and asking the agency to not pursue regulatory revisions to reduce the aforementioned T&E requirements for individuals without appropriate board certification. The NRC staff and Commissioners intend to make a decision later this year on whether or not to open up the rulemaking process. Moving forward, ACR will continue to work to promote the best interests of patients and the public on this important health and radiation safety issue.

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