ML19155A372

May 23, 2019 Summary of Public Meeting on the NRC Staff'S Draft Approaches Regarding Training and Experience Requirements for Radiopharmaceuticals

ML19155A372
Person / Time
Issue date:	06/04/2019
From:	Sarah Lopas NRC/NMSS/DMSST/MSEB
To:	Christian Einberg Office of Nuclear Material Safety and Safeguards
Sarah Lopas, X6360
Shared Package
ML19155A374	List: ML19155A372
References
Download: ML19155A372 (4)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 June 4, 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 23, 2019, WEBINAR TO ACCEPT COMMENTS ON THE U.S. NUCLEAR REGULATORY COMMISSION STAFFS DRAFT APPROACHES REGARDING TRAINING AND EXPERIENCE REQUIREMENTS FOR ADMINISTERING RADIOPHARMACEUTICALS (84 FR 18874)

Meeting Identifier: 20190478 Date of Meeting: Thursday, May 23, 2019 Location: N/A - Webinar 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 (May 14 and May 23) 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, 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 official public notice for the May 23 meeting, which contained information on webinar registration and bridge line instructions for remote attendees (ADAMS Accession No. ML19134A181). Ahead of the meeting, 43 people pre-registered for the webinar. The May 23 meeting, which was webinar only, began at 10:00 a.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. ML19141A131. 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. ML19149A525. Approximately 40 people participated in the meeting:

30 people logged into the webinar and 10 people called into the bridge line but did not log into the webinar. Four participants asked questions and provided comments. A list of participants who logged into the webinar is enclosed. The meeting concluded at 11:23 a.m. EDT.

Summary of Comments Received:

The first commenter identified as a member of the Nuclear Medicine Residents Organization, which is part of the American College of Nuclear Medicine. The commenter stated that reducing the amount of T&E required to administer radiopharmaceuticals would be dangerous. The commenter pointed out that each nuclear medicine patient is unique and the radiopharmaceutical dose and associated patient care given by the physician AU is tailored to the patients unique needs and considerations like exact diagnosis, imaging findings, diet, other medications, and home life. The commenter said they did not understand how a limited amount of training could account for the experience gained during a nuclear medicine residency. The commenter stated that allowing limited-trained AUs to administer radiopharmaceuticals would be like experimenting with patients health. The commenter also pointed out that nuclear medicine is expensive (tens of thousands of dollars sometimes), errors are very costly, and nuclear medicine couldnt afford that kind of economic hit. The commenter spoke again later in the meeting and acknowledged that while authorized nuclear pharmacists (ANPs) may have greater experience than AUs in handling radiopharmaceuticals, they did not believe that ANPs should be involved in the administration of radiopharmaceuticals.

The next commenter identified as a member of United Pharmacy Partners, Inc. and began by pointing out that cardiologists were able to receive limited AU training and that led to a revolution in nuclear cardiology, including formation of a professional society and a medical specialty board certification program. The commenter stated that much of the training an ANP and an AU receives is parallel, and noted there is special expertise that both parties have.

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The commenter stated that pairing a limited-trained AU with an ANP could allow the parties knowledge and experience to complement each another and radiopharmaceuticals could be safely handled and administered. The commenter did note the need to clearly define the roles and responsibilities of each team member for any of the team-based approaches. The commenter also expressed support for the idea that a limited curriculum could be developed to adequately train non-nuclear or non-radiologist physicians to work with ANPs. The commenter said that teaming ANPs with limited-trained AUs could expand patient access to alpha- and beta-emitting radiopharmaceuticals. (Following this comment, NRC Health Physicist Maryann Ayoade clarified that while some of the classroom and laboratory training required to become an ANP and an AU may be similar, the work experience portion of the training requirements differ.)

The third commenter identified as a nuclear medicine resident and strongly opposed creation of any limited-trained AU pathways. The commenter stated that we should not be subjecting patients to low-level trained physicians or support staff for radiopharmaceutical therapies. The commenter did not support the team-based approach involving a limited trained AU and an ANP-the commenter stated that this situation would subject patients to undue risk.

The final commenter objected to the NRCs use of the term patient ready. The commenter said that patient-ready only refers to the shipping of unit-dose delivery systems, and that the form of the radiopharmaceutical is irrelevant to the AUs use of these therapies and patient care.

The commenter said that patient ready is a term weighted by the pharmaceutical industry to diminish the responsibilities of AUs to patients, care team members, regulators, and the public.

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 the previous public comment meeting held on May 14, 2019 (ADAMS Accession No. ML19144A259), 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 site: https://www.regulations.gov/docket?D=NRC-2018-0230.

ENCLOSURE:

As stated 3

PKG ML19155A374; Meeting Summary ML19155A372 NRC Slide Presentation ML19141A131; Meeting Notice ML19141A414, Meeting Transcript ML19149A525

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

DATE 05/31/19 06/03/19 06/04/19 OFFICE NMSS/MSST/MSEB/PM NAME SLopas DATE 06/04/19 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 23, 2019 Meeting Participants Name Affiliation (if known)

Michael Baxter AlphaNet, Inc.

Janice Campbell Beaumont Hospital Ashley Cockerham Mercurie Consulting David Crowley State of North Carolina Ariel Doucet Virtua Health System Lisa Forney Commonwealth of Pennsylvania Sandy Gabriel Tina Getachew American College of Radiology Noelle Geier Froedtert Health Clinics Jenny Goodman State of New Jersey Michael Guastella Council on Radionuclides and Radiopharmaceuticals, Inc.

Caitlin Kubler Society of Nuclear Medicine and Molecular Imaging Georgia Lawrence American College of Nuclear Medicine Lisa Lemen Vicki LaRue State of New Jersey Michael Peters American College of Radiology Aria Razmaria UCLA Medical Center Erin Reynolds Commonwealth of Pennsylvania Joseph Rubin United Pharmacy Partners, Inc.

Judith Schuerman State of Louisiana Devin Shiple Neal R. Gross and Co.

Michael Snee State of Ohio Michael Sheetz University of Pittsburgh Jared Thompson State of Arkansas Cindy Tomlinson American Society for Radiation Oncology John Witkowski United Pharmacy Partners, Inc.

Daniel Yokell Massachusetts General Hospital - Harvard Medical School 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 Ian Irvin NRC/OGC Andrea Kock NRC/NMSS/MSST Sarah Lopas NRC/NMSS/MSST/MSEB Michelle Simmons NRC/RIV/DNMS/MIB Irene Wu NRC/NMSS/MSST/MSEB ENCLOSURE