May 29, 2019
The Nuclear Regulatory Commission (NRC) has proposed changes to the training and experience currently required to administer radiopharmaceuticals for which a written directive is required.
The current requirements state that in order to be qualified, a physician must
- be certified by a medical specialty board whose certification process is recognized by the NRC or an Agreement State;
- satisfy the training and experience requirements of an alternate pathway, including completing a structured educational program and supervised work experience (i.e., seminars, online training, vendor training) totaling 700 hours, including a minimum of 200 hours of classroom and laboratory training and 500 hours of supervised work experience; or
- be previously identified as an authorized user (AU) on an NRC or Agreement State license or permit.
The reason for the proposed changes is that certain stakeholders stated concerns with the current requirements, namely:
- The 700-hour requirement is overly burdensome for physicians who are not certified by a medical specialty board, resulting in a shortage of AUs.
- The shortage of AUs limits patient access to certain therapeutic radiopharmaceuticals.
The proposed changes: Four new “draft approaches” are offered to the public for comment, in general reducing the number of required hours from 700 to 400:
- Maintaining the current requirements
- Reducing the requirements to allow “limited authorized users” for different classes of radiopharmaceuticals
- Shifting oversight of competency to an examination authority or licensee
- Shifting competency requirements from an individual to a team with complementary training and experience.
Click here for a full explanation of the four draft approaches.
WHY IT’S IMPORTANT
- Any reduction in current 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, so there is no reason for a change in the current requirements.
WHAT SNMMI IS DOING
The society opposes any reduction in training and experience requirements, with the concerns stated above.
This is the NRC’s third request for comments, each related to different proposals.
SNMMI has been highly engaged on this issue. The society submitted responses to each previous request, in July 2018 and January 2019. The society's expert work group will address the open notice and questions included in the notice.
SNMMI, along with the American College of Radiology (ACR) and the American Society for Radiation Oncology (ASTRO), requested a 30-day extension on the comment period, which was granted by the NRC.
The NRC accepted oral comments during two public meetings, on May 14 and May 23. SNMMI staff and leadership, along with many members, attended the meeting in person and via teleconference.
The new deadline for comments is July 3, 2019.
This is one of several information-gathering activities that will help the agency decide whether to open this up to rule-making.
>> SNMMI encourages all members to submit their own comments.<<