ML19144A256

Summary of Meeting on NRC Staff'S Draft Approaches Regarding Training and Experience Requirements for Radiopharmaceuticals

ML19144A256
Person / Time
Issue date:	05/24/2019
From:	Sarah Lopas NRC/NMSS/DMSST/MSEB
To:	Christian Einberg Office of Nuclear Material Safety and Safeguards
Sarah Lopas 415-6360
References
20190471
Download: ML19144A256 (8)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 May 24, 2019 MEMORANDUM TO: Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards FROM: Sarah L. Lopas, Project Manager /RA/

Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards

SUMMARY

OF MAY 14, 2019, PUBLIC MEETING TO ACCEPT COMMENTS ON THE U.S. NUCLEAR REGULATORY COMMISSION STAFFS DRAFT APPROACHES REGARDING TRAINING AND EXPERIENCE REQUIREMENTS FOR ADMINSTERING RADIOPHARMACEUTICALS (84 FR 18874)

Meeting Identifier: 20190471 Date of Meeting: Tuesday, May 14, 2019 Location: Webinar and Commission Hearing Room, U.S. Nuclear Regulatory Commission (NRC) Headquarters, Rockville, MD Type of Meeting: Category 3 Purpose of the Meeting: To solicit comments from the public and stakeholders on the NRC staffs draft approaches regarding the training and experience (T&E) requirements for a physician to become an authorized user (AU) for medical uses under Subpart E, Unsealed Byproduct MaterialWritten Directive Required, of Title 10 of the Code of Federal Regulations (10 CFR) Part 35, Medical Use of Byproduct Material.

General Details: On May 2, 2019, the NRC published a Federal Register notice (FRN) requesting comments on the staffs draft approaches regarding the T&E requirements for administering radiopharmaceuticals requiring a written directive in accordance with the NRCs regulations under 10 CFR 35.300. The FRN (84 FR 84874) can be accessed in the NRCs Agencywide Documents Access and Management System (ADAMS; https://www.nrc.gov/reading-rm/adams.html) under Accession No. ML19136A353, or on the Federal Register Web site athttps://www.federalregister.gov/documents/2019/05/02/2019-08996/draft-approaches-for-addressing-training-and-experience-requirements-for-radiopharmaceuticals.

The publication of the FRN opened a one-month public comment period to obtain input on the staffs draft approaches. The NRC is interested in obtaining input from as many medical and regulatory stakeholders as possible, including professional organizations, physicians, patients, patient advocacy groups, licensees, Agreement States, and other interested individuals. Two public meetings were planned to accept oral comments, and written comments can be submitted on the Federal governments rulemaking Web site, www.Regulations.gov, by searching docket ID NRC-2018-0230. The comment period was originally scheduled to end on June 3, 2019; however, subsequent to the May 14th public meeting, the NRC granted a 30-day extension to allow stakeholders more time to submit their comments. An FRN was published on May 23, 2019, announcing the 30-day extension (84 FR 23812). The comment period now ends on July 3, 2019.

On May 1, 2019, the NRC published the meeting notice, which contained information on how to attend in-person, and webinar registration and bridge line instructions for remote attendees (ADAMS Accession No. ML19134A181). Ahead of the meeting, 53 people pre-registered for the webinar and 5 people registered to attend the meeting in-person at NRC headquarters.

The meeting began at 1:00 p.m. EDT and included a 45-minute presentation from NRC staff on background information regarding the staffs evaluation of T&E under 10 CFR 35.300, and the staffs draft approaches regarding the T&E requirements. The NRCs slide presentation can be found in ADAMS at Accession No. ML19133A090. Following the staffs presentation, the meeting was then opened to receive public comments. All meeting participants who wanted to provide a comment were given the opportunity to speak. The meeting was transcribed by a court reporter, so staff could capture the comments for the T&E docket (NRC-2018-0230). The meeting transcript can be found in ADAMS at Accession No. ML19141A119. Approximately 61 people participated in the meeting: 41 people logged into the webinar, 15 people called into the bridge line but did not log into the webinar, and 5 external participants attended in-person.

Fifteen participants asked questions and provided comments. A list of meeting participants who attended in-person and logged into the webinar is enclosed. The meeting concluded at 3:02 p.m. EDT.

Summary of Comments Received:

The first commenter spoke on behalf of the American Association of Physicists in Medicine (AAPM) and stated that any arbitrary reduction in the T&E requirements would compromise safety for patients, staff, and the general public. The commenter said there was no need for a change to the current T&E requirements, and that the Advisory Committee on the Medical Uses of Isotopes (ACMUI) looked at the distribution of AUs in the U.S. and there seemed to be quite enough. The commenter noted there are portions of the U.S. where healthcare was limited but that this included not just AUs but also medical oncologists in general. The commenters third point was that the decrease in use of some radionuclide therapies was not due to a lack of AUs, nor the refusal of AUs to administer the therapies, but instead the fact that referrals from medical oncologists had decreased markedly because facilities had found better ways to treat those cancers. The commenters fourth point was that all radionuclide therapies require the same amount of T&E for the AU to develop a broad understanding of the effects, doses, and hazards.

The second commenter strongly supported the current 700-hour T&E requirement. The commenter was the Executive Director of the American Board of Nuclear Medicine (ABNM) and noted that ABNM was aware of situations where program directors were pressured by superiors 2

to provide attestations for physician trainees who hadnt fulfilled all the requirements under the alternate pathway (10 CFR 35.390(b)(1)). The commenter believed that the performance-based approach where hospitals develop their own policies and procedures to credential physicians and name AUs would exacerbate this problem. The commenter also stated that preceptor-based attestation alone would not be sufficient to ensure safety. Based on ABNM pass/fail rates for their initial board examination and periodic re-examinations, the commenter expressed support for adding an initial formal competency assessment and periodic reassessments to the existing alternate pathway.

The third commenter identified as a nuclear medicine physician and stated that according to a radiopharmaceutical company, radiopharmaceutical therapies currently comprise 13 percent of nuclear medicine practice, but that percentage was expected to grow to 30 by 2030. Because of this, the commenter stated that appropriate T&E requirements were necessary to create highly trained, skilled, and competent AUs. The commenter requested a 30-day extension to the public comment period. The commenter requested that as part of the evidence to support changing the T&E requirements, the NRC provide a full list of citations or violations (i.e., medical events) that were related to T&E. The commenter noted that 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> may have been set arbitrarily in the past, however it has been shown to work over time. The commenter said that a reduction of T&E to 400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br /> was arbitrary with no supporting evidence. The commenter stated that competency should be assessed in four ways - certification by a recognized medical specialty board, passing a radiation safety exam, work experience in an accredited laboratory, and periodic (e.g., annual) proficiency testing through a laboratory exercise and graded quiz.

The commenter strongly opposed the team-based approaches but noted that a multi-disciplinary team effort was best suited to treat oncology patients. Regarding FRN question 7 regarding how to credential physicians in small practices, the commenter did not support credentialing physicians in small practices (in rural areas) due to their potential lack of infrastructure to handle radiopharmaceutical therapies. The commenter stated that people living in rural areas understand they must travel for medical specialty or sub-specialty expertise. The commenter said that tailored T&E requirements would be difficult to establish and horrendously difficult to regulate. The commenter cited lutetium-177 prostate-specific membrane antigen (PSMA) and actinium-225 PSMA as new radiopharmaceuticals that would likely gain wider use in the near future.

The fourth commenter expressed support for the previous comments and reiterated that because radiopharmaceutical therapy is very complex, there should be no relaxation of the T&E requirements and the current requirements should be maintained. The commenter stated that the medical oncologists they worked with had no desire to administer radiopharmaceuticals and because they knew it was best left in the hands of nuclear medicine and radiation oncology physicians. The commenter also supported initial and ongoing competency assessments for AUs. Later in the meeting this commenter also raised concerns about how the physician credentialing approach would be implemented, specifically in that some hospitals may have a financial incentive to implement more lenient T&E requirements, including less rigorous documentation of their physicians T&E. The commenter stated that if the NRC no longer approved and reviewed T&E, that T&E should be left entirely in the hands of the medical specialty boards, and not left up to medical institutions.

The fifth commenter was opposed to establishing limited AU pathways because they said it may result in medical uses of radiopharmaceuticals at facilities that could not provide needed medical care and may not have physical systems in place to ensure radiation safety. The commenter stated that the best place to receive radiopharmaceutical therapy was at a facility 3

with an entire team of medical professionals, including fully-trained AUs, who have extensive training and experience in safely performing radiopharmaceutical therapy - these facilities could handle complications if they arose. The commenter stated that based on the current number of AUs and those in the pipeline of the medical specialty boards, and even with the expected increase in future radiopharmaceutical therapies, the commenter did not believe there was an AU shortage.

The sixth commenter submitted a comment via the webinar on behalf of the American Pharmacists Association, Academy of Pharmacy Practice and Management, Nuclear Pharmacy Practice Specialist Special Interest Group. The commenter stated that in restructuring the T&E requirements, the NRC should carefully recognize and consider the various healthcare team members involved in safely handling and administering radiopharmaceuticals, including the important role of authorized nuclear pharmacists (ANPs). The commenter stated that the T&E requirements may need to be decreased but it may be difficult to quantify T&E by hours versus competency-based training.

The next commenter asked how the NRC would consider Subpart N, Enforcement, of 10 CFR Part 35 in each of its draft approaches, and how the NRC would provide oversight to prevent an AU from providing false information to credentialing boards. The commenter stated that currently there is no way for the public to know when this happens. NRC staff member, Ms.

Sophie Holiday, responded that the NRC and Agreement States allegation processes would investigate concerns regarding false credentialing information, and appropriate action would be taken if concerns were substantiated.

The eighth commenter stated that for any of the team-based approaches, the AU who is part of the team should be a fully-trained AU. The commenter did not support performance-based T&E for AUs in the team-based approach - they believed a set number of hours should be required for the AU. The commenter also did not support the tailored T&E approach of any one radiopharmaceutical. The commenter said that an AU needed broader training than just focusing on one specific radiopharmaceutical.

The next commenter spoke on behalf of United Pharmacy Partners, Inc. (UPPI) and noted the significant number of new radiopharmaceuticals coming down the pike. The commenter noted that the ACMUI, during the February 26, 2019 public teleconference on T&E (ADAMS Accession No. ML19072A259) called UPPIs limited-trained AU paired with an ANP idea novel, well-intentioned, and worth of extensive consideration. The commenter stated that ANPs had the same basic 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of T&E as AUs, and so the T&E should be considered equivalent. NRC staff member, Maryann Ayoade, later pointed out that there were important differences in the T&E for ANPs and AUs, and the T&E was not equivalent. The commenter later asked about the status of the NRCs effort to map facilities licensed to use materials under 10 CFR 35.300. NRC staff member Sarah Lopas responded that staff was still working on that effort and maps of those facilities would be included as an enclosure to the staffs T&E Commission paper.

A commenter representing Bayer Healthcare noted that their radiopharmaceutical, Xofigo, represented a different type and scale of radiation risk based on its emission type, dosage, and administration protocol, and that Bayer strongly supported the physician credentialing approach or any risk-informed approach for T&E.

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The eleventh commenter identified as a radiation safety office for several facilities and a representative of AAPM. The commenter noted that AAPM supported the current T&E requirements. The commenter brought up concerns about supervision by the AU when a team member other than the AU administered the radiopharmaceutical. Considering that T&E is solely focused on AUs, the commenter was interested in hearing other stakeholders opinions on supervision requirements for AUs.

The twelfth commenter spoke on behalf of the American College of Nuclear Medicine (ACNM) and stated that ACNM was in favor of status quo. The commenter stated that both alpha- and beta-emitting radiopharmaceuticals posed unique concerns and safety issues for patients, so they should not be taken lightly. The commenter stated that patient safety needed to be protected and thus the NRC should not reduce the T&E requirements.

The thirteenth commenter identified as a radiology resident and they supported previous comments in support of maintaining the current T&E requirements. The commenter addressed FRN question number 18 regarding which approaches would best position the NRC to regulate the future of radiopharmaceuticals - the commenter stated that they believed this was best done through the training programs of the ABNM, the American Board of Radiology, and the other recognized medical specialty boards. The commenter did not support small-practices self-determining whether their physicians had appropriate T&E to be AUs. The commenter thought that the physician credentialing option would result in differing standards of care across facilities. The commenter stated that the currently recognized medical specialty boards, together with the NRC, have a successful history in ensuring the safe use of radiopharmaceuticals, and because of this, they did not support deviating from the current requirements and system.

A question was asked regarding when new NRC Forms 313 and 313a would be available, and if the T&E evaluation would impact those forms. NRC staff member Donna-Beth Howe answered that licensees should follow the instructions that replaced the posted forms and submit T&E information accordingly, until the new forms were available, which would likely be at the end of summer 2019. (The current T&E evaluation has no impact the forms.)

The final commenter suggested that the NRC should conduct a risk assessment of each radiopharmaceutical. They said the current T&E regulations are overly burdensome and arent based on risk, and they prevent physicians from administering medically-approved agents for their patients in need of these therapies. The commenter disagreed with the notion that all radiopharmaceuticals posed similar risks and therefore there was no need to create a spectrum of T&E based on risk.

A complete accounting of the comments and questions is contained in the meeting transcript, which is available in ADAMS at Accession No. ML19141A119.

Next Steps: The NRC staff will consider the comments received during this meeting, and during the rest of public comment period, as part of its evaluation of the 35.300 T&E requirements. The NRC staff will document its evaluation and recommendation in a report to the Commission, which is planned to be published in late 2019. The NRCs Web site on the T&E requirements evaluation will be regularly updated and can be found at:

https://www.nrc.gov/materials/miau/med-use-toolkit/training-experience-evaluation.html. All meeting transcripts and written comments will be available on the regulations.gov T&E docket 5

site: https://www.regulations.gov/docket?D=NRC-2018-0230. One additional public comment webinar on the staffs draft approaches for the T&E requirements was held on Thursday, May 23, 2019. A summary of that meeting and the meeting transcript will be posted on the T&E Web site within 30 days of the meeting.

ENCLOSURE:

As stated 6

PKG ML19144A259; Meeting Summary ML19144A256 NRC Slide Presentation ML19133A090; Meeting Notice ML19134A181, Meeting Transcript ML19141A119

• via email OFFICE NMSS/MSST/MSEB/PM NMSS/MSST/MSEB/TL NMSS/MSST/MSEB/BC NAME SLopas LDimmick* CEinberg*

DATE 05/22/19 05/23/19 05/24/19 OFFICE NMSS/MSST/MSEB/PM NAME SLopas DATE 05/24/19 Public Meeting to Accept Comments on the U.S. Nuclear Regulatory Commission Staffs Draft Approaches Regarding Training and Experience Requirements for Administering Radiopharmaceuticals (84 FR 18874)

May 14, 2019 Meeting Participants Name Affiliation (if known)

John Aarsvold Emory Hospital Sukhjeet Ahuja Society of Nuclear Medicine and Molecular Imaging (SNMMI)

Michael Baxter AlphaNet, Inc.

Gholam Berenji VA Greater Los Angeles Healthcare System Bette Blankenship American Association of Physicists in Medicine (AAPM)

Janice Campbell Beaumont Hospital Dalton Clark SNMMI David Crowley State of North Carolina Victor Diaz State of New Mexico Ariel Doucet Virtua Health System Mike Fuller State of Virginia Sandy Gabriel Munir Ghesani SNMMI Sheamus Gleason Bayer Healthcare Leonie Gordon Medical University of South Carolina Erin Grady American College of Nuclear Medicine Bennett Greenspan SNMMI Michael Guastella Council on Radionuclides and Radiopharmaceuticals, Inc.

Stanley Hampton Lilly Dan Hill Cardinal Health Robert Hobbs Johns Hopkins Medical Institute Christopher Kessler Marshfield Clinic Richard Martin AAPM Kimberly Mason Cardinal Health Andy McKinley American Society of Nuclear Cardiology Chris Mitchell Kettering Health Dominique Newallo Emory Hospital Niki Noll State of Pennsylvania Justin Peacock Brooke Army Medical Center Michael Peters American College of Radiology Joseph Rubin United Pharmacy Partners, Inc.

David Schuster Emory University George Segall American Board of Nuclear Medicine (ABNM)

Michael Sheetz University of Pittsburgh Arif Sheikh Mount Sinai Hospital Megan Shober State of Wisconsin George Segall ABNM Jeff Siegel Rachel Semon Advanced Accelerator Applications ENCLOSURE

Name Affiliation (if known)

Daniel Szatkowski Washington University St. Louis Bruce Thomadsen AAPM Cindy Tomlinson American Society for Radiation Oncology Ed Truskowski State of New Jersey Karl Von Ahn State of Texas Steven Walter NRC Attendees Maryann Ayoade NRC/NMSS/MSST/MSEB Lisa Dimmick NRC/NMSS/MSST/MSEB Chris Einberg NRC/NMSS/MSST/MSEB Jennifer Fisher NRC/NMSS/MSST/MSEB Sophie Holiday NRC/NMSS/MSST/MSEB Donna-Beth Howe NRC/NMSS/MSST/MSEB Ian Irvin NRC/OGC Kellee Jamerson NRC/NMSS/MSST/MSEB Harriet Karagiannis NRC/RES Andrea Kock NRC/NMSS/MSST Christine Lipa NRC/RIII/DNMS Sarah Lopas NRC/NMSS/MSST/MSEB Kevin Williams NRC/NMSS/MSST Irene Wu NRC/NMSS/MSST/MSEB 2