By Theodore DeWeese, MD, FASTRO, ASTRO Board Chair
On Wednesday, November 20, I met with Nuclear Regulatory Commission (NRC) Chairman Kristine Svinicki and commissioners Jeff Baran and Annie Caputo, as well as with NRC staff, to preserve strong training and experience (T&E) requirements for radiopharmaceuticals.
Over the past several years, in response to external pressure, the NRC staff has been reviewing the current requirements found in 10 CFR § 35.300 and 10 CFR § 35.390 to determine whether changes should be made. Part of this review has included outreach to stakeholders, including ASTRO, for their opinion and analysis of possible changes. As ASTRO chair, one of my priorities is to ensure that radiation oncologists play a leading role in the administration of radiopharmaceuticals. Fending off potential ill-advised changes to training and experience requirements will help achieve that goal.
Current regulations require that an authorized user (AU) be either board certified or complete 700 hours of training. The relevant sections of the regulations can be found here: Training for the use of unsealed byproduct material for which a written directive is required and Training for the parenteral administration of unsealed byproduct material requiring a written directive.
On the surface, reviewing current requirements to ensure their relevance is important and necessary. However, we are concerned that this review could initiate rulemaking to loosen the current 700-hour requirement – something that ASTRO, and partner organizations, oppose because the current requirements are appropriate, protect the safety of patients, the public, and practitioners, and should not be changed.
The NRC staff has concluded its review and is preparing a report to the commissioners. This report will outline policy options, as well as a recommendation for commission action. A version of the report was made public in October, so we were able to see the options the staff laid out; however, it did not include the staff’s final recommendation.
In the draft paper, the staff outlines two different approaches, each with several options, as follows:
Approach 1: Revise the T&E regulatory framework to remove prescriptive requirements, and the NRC and Agreement States would no longer review and approve T&E for AUs.
- Option 1a: Specialty Board Credentialing– Physicians must be certified by any medical specialty board.
- Option 1b: Licensee Credentialing– Licensees develop their own policies and procedures for credentialing their physicians.
- Option 1c: NRC-recognized Specialty Board Credentialing – Physicians must be certified by a medical specialty board that has been recognized by the NRC as meeting high-level board certification criteria.
Approach 2: Maintain or enhance the existing T&E regulatory framework.
- Option 2a: Status Quo– No changes.
- Option 2b: Tailored Requirements– T&E would be tailored and reduced for use of individual or categories of radiopharmaceuticals.
- Option 2c: Emerging Radiopharmaceuticals– Individual reviews of each emerging radiopharmaceutical to determine drug specific T&E and other requirements.
- Option 2d: Team-based Requirements– T&E would be reduced based on pairing AUs with other individuals with radiation safety training.
The staff paper also states: “The NRC regulates medical uses of byproduct material to ensure the safety of workers and the general public, and while patient access concerns were considered by the staff, the NRC cannot regulate T&E with a primary goal of increasing patient access to radiopharmaceuticals or improving geographic distribution of AUs.”
In response, the NRC’s Advisory Committee on the Medical Use of Isotopes (ACMUI), made the following ASTRO-supported recommendations:
- The Subcommittee recommends maintaining the status quo under 10 CFR § 35.390. While strongly affirming the structural superiority of the status quo over the other options proposed in the draft paper, we acknowledge there is room for a comprehensive review of the specific requirements in § 35.390 such as the seemingly arbitrary requirement of 700 hours. The Subcommittee (and likely, ACMUI) would welcome the opportunity to critically assess these details.
- If the NRC proceeds to grant AU status by NRC-recognized specialty boards, the T&E should be equivalent to § 35.390.
- The Subcommittee recognizes the value of an alternate pathway and is willing to review and evaluate the requisite knowledge, preceptor-reviewed experience and competency assessments.
ASTRO and I believe maintaining the status quo (Option 2a) for training and experience for radiopharmaceuticals is appropriate, protects the safety of patients, the public, and practitioners, and should not be changed. The NRC’s focus on patient safety and the safety of the general public as it develops training and experience requirements is appropriate. The classroom and clinical experiences encompassed by radiation oncology and nuclear medicine training programs provide appropriate levels of knowledge and skill for any current and future radioactive agents.
Reporting data also supports maintaining the status quo. While non-expert AUs would introduce significant radiation risks, radiopharmaceuticals — when administered under the supervision of comprehensively trained and experienced AUs — have an exemplary safety record, and the current regulations ensure that safety. In both 2017 and 2018, there was one event reported to the NRC using Ra-223. Between January 2014 and May 2019, only 16 out of 9,848 total events entered into RO-ILS: Radiation Oncology Incident Learning System® were related to radiopharmaceuticals. As indicated in the self-reported data, none of these events have been reported to either the NRC or an Agreement State.
Weakening AU T&E requirements would not create an influx of new licensed health care facilities providing these therapies in remote geographical areas. Rather, there are other considerations guiding facilities’ decisions, such as:
- availability/preference for alternative therapies,
- the high cost of these drugs,
- complexity of the patient cases, and
- financial and staff resources required (radiation safety officer services, technologists/therapists with appropriate licensure, license fees, etc.).
I was very pleased with the meetings, and I came away hopeful that ultimately the NRC will keep the status quo and will not initiate new rulemaking to lessen the current T&E requirements. ASTRO will keep up the pressure and continue reporting on developments.
ASTRO is interested in receiving your feedback regarding the T&E requirements for radiopharmaceuticals. Use the comments below to share your thoughts.