May 16, 2019
On Thursday May, 2, the U.S. Nuclear Regulatory Commission (NRC) published a notice in the Federal Register announcing a 30-day public comment period and two public meetings on the NRC staff’s draft approaches regarding training and experience requirements for administration of radiopharmaceuticals requiring a written directive. This request for comments is the second comment period on this issue in 2019.
SNMMI has been highly engaged on this issue and most recently submitted comments in January 2019 and July 2018. The society does not support any reduction in training and experience requirements. The society's comments highlight several concerns:
- SNMMI believes any reduction the training and experience requirements will compromise the safety of patients, their caregivers, and family members.
- Parenteral radionuclide therapy can be administered safely only by personnel with an extensive understanding of radiation physics, radiopharmacy, pharmacokinetics, dosimetry, and radiation biology, as well as the principles and practices of radiation safety.
- There is no identified shortage of Authorized Users to warrant a change in the current requirements.
This is one of several information-gathering activities that will help the agency decide whether to open this up to rule-making. The society's expert work group will address the open notice and questions included in the notice. Although SNMMI will be submitting comments, we encourage all members to submit their own comments. The comment period will end on June 3, 2019.
NRC states this new comment period is a result of input received during the November 2018 public comment period and the Advisory Committee on Medical Uses of Isotopes T&E subcommittee's report dated February 27, 2019. NRC staff developed several draft approaches. These approaches include:
- Status Quo: “Status Quo” presents no changes to the current T&E requirements for radiopharmaceuticals requiring a written directive under 10 CFR 35.300.
- Tailored Training and Experience Requirements: The four approaches under this section would modify the existing T&E requirements under 10 CFR 35.390, “Training for use of unsealed byproduct material for which a written directive is required.” The approaches described under Sections B.1, B.2, and B.3 would require a set amount of T&E tailored to the specific radiopharmaceuticals, and the “Emerging Radiopharmaceuticals” approach described under Section B.4 would tailor T&E requirements for each new radiopharmaceutical as they were developed, similar to the approach for regulating new technologies under 10 CFR 35.1000, “Other Medical Uses of Byproduct Material or Radiation from Byproduct Material
- Limited AU for alpha or beta-emitting radiopharmaceuticals: Under this approach, any physician could complete at least 400 hours of T&E to be authorized to administer any alpha- or beta-emitting radiopharmaceutical. The T&E would consist of 200 hours of classroom and laboratory training and a minimum of 200 hours of supervised work experience tailored to alpha- and beta-emitting radiopharmaceuticals. Preceptor attestation would be required.
- Limited AU for unit-dose, patient-ready radiopharmaceuticals: Under this approach, any physician could complete at least 400 hours of T&E to be authorized to administer any unit-dose, patient-ready radiopharmaceutical. The T&E would consist of 200 hours of classroom and laboratory training and a minimum of 200 hours of supervised work experience tailored to unit-dose, patient-ready radiopharmaceuticals. Preceptor attestation would be required.
- Limited AU for any one parenteral radiopharmaceutical: Under this approach any physician could complete at least 400 hours of T&E to be authorized to administer any one parenteral radiopharmaceutical. The T&E would consist of 200 hours of classroom and laboratory training and a minimum of 200 hours of supervised work experience tailored to the radiopharmaceutical they wish to administer. Preceptor attestation would be required. Limited AUs who have initially completed their at least 400 hours of T&E and then wish to administer a different radiopharmaceutical would be required to complete, minimally, an additional 80 hours of tailored, supervised work experience for each additional radiopharmaceutical.
- Emerging radiopharmaceuticals: Like the NRC's regulations at 10 CFR 35.1000, under this approach the NRC would conduct individual reviews of each new emerging radiopharmaceutical to determine T&E requirements specific to the new radiopharmaceutical. The T&E requirements could be tailored to consider potential users of the radiopharmaceutical (e.g., non-nuclear medicine or non-radiation oncology physicians wishing to administer the radiopharmaceutical for their patients with indicated cancers), thus creating alternate T&E pathways for each new radiopharmaceutical.
- Performance-Based: The approaches described in this section would remove prescriptive T&E requirements from the regulations and instead would focus oversight on the performance-based aspects of a licensee's medical program for the administration of radiopharmaceuticals.
- Competency Based Evaluation: Under this approach, proposed AUs would be required to demonstrate competency in radiation safety topics and radiation safety-related job duties through a formal competency evaluation (e.g., an examination or preceptor attestation)
- Credentialing of Authorized Users: Under this approach, the NRC would no longer review and approve T&E qualifications for all AUs under 10 CFR part 35. Instead, licensees would develop and use their own policies and procedures to make self-determinations of whether their credentialed physicians have the appropriate T&E to be an AU for one or more radiopharmaceuticals under 10 CFR 35.300. Licensees would be required to maintain a training program that ensures compliance with the requirements in 10 CFR 35.41, “Procedures for administrations requiring a written directive,” and 10 CFR part 20, “Standards for Protection Against Radiation.”
- Team-Based: Team-based approaches could remove prescriptive T&E requirements for AUs, focus training requirements on the competency of the entire team, or revise the current 700-hour T&E requirement for AUs based on pairing the AU with another individual with expertise in administering radiopharmaceuticals
- Radiopharmaceutical Team: Licensees would need a team to administer radiopharmaceuticals under 10 CFR 35.300. The team would minimally consist of an AU, a radiation safety officer, and a nuclear medicine technologist.
- Licensees would need both an AU and an authorized administrator (AA) to administer radiopharmaceuticals under 10 CFR 35.300.
- Partner Limited-Trained AUs with Licensed Nuclear Pharmacist: The T&E for AUs would be at least 400 hours, however, the AU would be required to physically partner with an authorized nuclear pharmacist (ANP) for all administrations of radiopharmaceuticals. Unlike the approaches in Sections D.1 and D.2 above, prescriptive T&E would be required for the AU in this approach due to the AU's more prominent role in the administration of radiopharmaceuticals. The minimum of 400 hours of T&E for the physician partnering with an ANP would be focused on supervised work experience and patient cases, and preceptor attestation would be required. The AU would be responsible for administration of radiopharmaceuticals in accordance with the written directive, and the ANP would be responsible for radiation safety-related duties.
Additional questions from the NRC for considerations:
- Question 10: What are the advantages and disadvantages of the draft approaches?
- Question 11: Are there significant costs or benefits associated with any of the approaches?
- Question 12: Would any of the draft approaches impact patient access to radiopharmaceuticals or address stakeholder concerns of overly burdensome (regulatory) requirements
- Question 13: For the draft approaches that consider tailored hours of T&E, what are the appropriate numbers of hours and what radiation safety topics should comprise the limited T&E?
- Question 14: Should the NRC consider inclusion of a formal radiation safety competency assessment and periodic reassessments for any of the draft approaches above? If so, who should establish and administer these assessments?
- Question 15: How would the draft approaches impact the medical organizations that use the NRC's T&E requirements as a basis for establishing their training programs?
- Question 16: Are there concerns regarding implementation and/or viability for any of the approaches discussed above?
- Question 17: Are there any unintended consequences of the draft approaches?
- Question 18: Which of the draft approaches best positions the NRC to effectively regulate future radiopharmaceuticals?
- Question 19: Should the NRC continue to play a role in the review and approval of AUs?
The NRC is accepting oral comments during two public meetings, scheduled for May 14 and May 23. The society and many other members attended the May 14 meeting in Rockville, MD and via teleconference. The second meeting is open and accessible for remote participation by moderated bridge line and webinar. NRC’s public meeting Web site will be updated with meeting details at least 10 days before the meetings.