ML19002A614
| ML19002A614 | |
| Person / Time | |
|---|---|
| Issue date: | 01/09/2019 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB |
| To: | Christian Einberg Office of Nuclear Material Safety and Safeguards |
| Sarah Lopas | |
| Shared Package | |
| ML19002A615 | List: |
| References | |
| Download: ML19002A614 (4) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 January 9, 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
SUBJECT:
SUMMARY
OF PUBLIC MEETING TO ACCEPT COMMENTS ON THE U.S. NUCLEAR REGULATORY COMMISSIONS EVALUATION OF TRAINING AND EXPERIENCE REQUIREMENTS FOR ADMINSTERING DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS (83 FR 54380)
Meeting Identifier: 20181166 Date of Meeting: Tuesday, December 11, 2018 Location: Webinar and Commission Hearing Room, One White Flint Building, NRC Headquarters, Rockville, MD Type of Meeting: Category 3 Purpose of the Meeting:
To solicit comments from the public and stakeholders on the U.S. Nuclear Regulatory Commissions (NRC) evaluation of the training and experience (T&E) requirements for a physician to become an authorized user 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 October 29, 2018, the NRC published a Federal Register notice (FRN) requesting comments on the NRCs T&E requirements for administering different categories of radiopharmaceuticals requiring a written directive in accordance with the NRCs regulations under 10 CFR 35.300. The FRN (83 FR 54380) can be accessed in the NRCs Agencywide
C. Einberg Documents Access and Management System (ADAMS; https://www.nrc.gov/reading-rm/adams.html) under Accession No. ML18276A166, or on the Federal Register Web site at https://www.federalregister.gov/documents/2018/10/29/2018-23521/training-and-experience-requirements-for-different-categories-of-radiopharmaceuticals.
The publication of the FRN opened a three-month public comment period to obtain input on whether the NRC should tailor its T&E requirements for administering different categories of radiopharmaceuticals requiring a written directive. The NRC is interested in obtaining input from as many stakeholders as possible, including members of the Advisory Committee on the Medical Uses of Isotopes, professional organizations, physicians, patients, patient advocacy groups, licensees, Agreement States, and other interested individuals. Four 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 ends on January 29, 2019.
On November 1, 2018, the NRC published the December 11 meeting notice, which contained information on how to attend in-person, and webinar registration and bridge line instructions for remote attendees (ADAMS Accession No. ML18344A046). Ahead of the meeting, 25 people registered for the webinar and 9 people registered to attend the meeting in-person.
The meeting began at 1:00 p.m. EST and included a 30-minute presentation from NRC staff on the staffs planned evaluation of T&E under 10 CFR 35.300. The NRCs slide presentation can be found in ADAMS at Accession No. ML18341A142. 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. ML19002A566. Approximately 34 people participated in the meeting: 18 people logged into the webinar, 4 people called into the bridge line but did not log into the webinar, and 12 people attended in-person. Six participants provided comments. A list of meeting participants who attended in-person and logged into the webinar is enclosed. The meeting concluded at 2:44 p.m. EST.
Summary of Comments Received:
The first commenter stated that the current geographic distribution of authorized users (AUs) has a detrimental effect on patient access to radiopharmaceuticals, especially in more rural areas of the United States. To address this issue, the commenter urged the Commission to consider enabling the teaming of onsite nuclear pharmacists with a limited authorized user physician (who may have 80 or 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of T&E versus 700). The commenter stated that instead of reducing T&E, this approach would allow the nuclear pharmacist and a specialist physician to team up to fill the full T&E requirements as they pertain to radiation protection, patient care, and safety. The commenter stated that nuclear pharmacists undergo 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of T&E to become an authorized nuclear pharmacist, and that nuclear pharmacists have more responsibility for radiation safety, handling, use, and transport than anyone else in the nuclear medicine system. The commenter stated that the nuclear pharmacist could handle the radiation safety aspect of the treatment, and the physician could focus on the patient care aspect. The commenter stated that this team approach could dramatically expand the service area for 2
C. Einberg nuclear medicine procedures because nuclear pharmacists are more broadly spread across rural markets. The commenter cited critical shortages of physicians in rural areas as reported by the National Rural Healthcare Association and said there was no reason to be believe that the distribution of AUs differed from the general physician statistics.
The next commenter echoed the above comments regarding teaming a nuclear pharmacist with a physician. The commenter stated that the NRC should keep in mind the future expansion of nuclear medicine and the idea that radiopharmaceuticals requiring a written directive will become a greater portion of therapies available to patients. The commenter also stated that the team approach was like the dual authorized user situation that the NRC was familiar with in the past. The commenter stated that in situations where there are several rounds of treatment associated with a particular therapy, improving geographic distribution and thus access could be very helpful to those patients, who may currently face long travel distances to receive treatment.
Another commenter suggested that the NRC should be open to all avenues that would improve patient access to radiopharmaceuticals, however, the commenter acknowledged the need to balance public and worker safety with improving patient access. The commenter stated that the NRC should continue their dialogue with industry to learn more about specific categories of radiopharmaceuticals, such as specific routes of administration or unique practice setting requirements, and how, through additional opportunities for training and education, additional competencies could be gained so more patients could access these therapies. The commenter spoke about a University of New Mexico online training program for nuclear pharmacists that offers 200 online didactic hours, and coordinates with and mentors on-site preceptors to deliver 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised experience. With the above-referenced online training program as an example, the commenter encouraged an open mind regarding how T&E could be achieved.
The commenter also mentioned that the above-referenced online training helped to address recentness-of-training issues. Later in the meeting the commenter discussed the idea that currently there are clinician pharmacists who work under the supervision of a physician to administer pharmaceutical therapies for diseases that require drug-intensive treatment. The commenter then reiterated that nuclear pharmacists have the most experience working with radiopharmaceuticals and they could bring value in terms of drug administration, whereas the physician would make treatment decisions and write directives. The commenter thought that specializing training, perhaps drug- or isotope-specific, could have value. The commenter also noted a current bill in Congress to designate pharmacists as providers could have some bearing on the NRCs evaluation.
One commenter asked for clarification that the T&E evaluation was only addressing higher risk radiopharmaceuticals used for therapy, and not the lower risk radiopharmaceuticals that are used for diagnostics. NRC staff confirmed the commenters understanding that the current evaluation is examining radiopharmaceuticals under 10 CFR 35.300. Another commenter disagreed with the terms high and low risk when describing radiopharmaceuticals.
In response to the previous comments regarding teaming an authorized nuclear pharmacist with a limited authorized user, another commenter asked for clarification on whether that the NRC was open to the idea of other individuals besides physicians becoming AUs or teaming up with AUs to meet T&E requirements. NRC staff confirmed that they were open to all ideas and comments regarding T&E, including how and by whom those requirements could be met. The 3
C. Einberg commenter also expressed some concern about whether the NRCs consideration of T&E requirements broached clinical patient care aspects. The commenter later expressed surprise that the NRC didnt have patient access data readily available and supported the idea that the NRC should request patient access data from the Agreement States.
The final commenter of the day stated that there was and should be a clear delineation between physicians who undergo years of specialized training in nuclear medicine, and nuclear pharmacists or other non-AU individuals. The commenter did not support comments made earlier in the meeting regarding individuals other than physicians being able to meet limited T&E requirements to administer certain categories of radiopharmaceuticals. The commenter stated that quality of care of could be impacted if these non-AU routes are considered, and that the point was not profit, but patient care. The commenter also pointed out that new therapies coming down the pipeline had significant toxicities associated with them, and they were not simple injections, furthering supporting his argument that only rigorously trained physicians should be authorized to administer these therapies.
A complete accounting of the comments is contained in the meeting transcript, which is available in ADAMS at Accession No. ML19002A566.
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 fall 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. Additional public comment meetings on T&E are scheduled for January 10, 2019 and January 22, 2019. The NRCs public meeting schedule Web site contains participation details for these upcoming meetings:
ENCLOSURE:
As stated 4
PKG ML19002A615; Meeting Summary ML19002A614 NRC Slide Presentation ML18341A142; Meeting Notice ML18344A046, Meeting Transcript ML19002A566
- via email OFFICE NMSS/MSST/MSEB/PM NMSS/MSST/MSEB/TL NMSS/MSST/MSEB/BC NAME SLopas LDimmick* CEinberg*
DATE 01/03/19 01/08/19 01/09/19 OFFICE NMSS/MSST/MSEB/PM NAME SLopas DATE 01/09/19 Public Meeting to Accept Comments on the U.S. Nuclear Regulatory Commissions Evaluation of Training and Experience Requirements for Administering Different Categories of Radiopharmaceuticals (83 FR 54380)
December 11, 2018 Meeting Participants Name Affiliation (if applicable)
Janice Campbell Beaumont James Cordes Neal Gross Court Reporters Guiliana Del Guercio CRD Associates Dawn Edgerton Inteleos Elizabeth Franklin Atrium Health Jennifer Gersman Northwestern Medicine Tina Getachew American College of Radiology Vicki Larue National Jewish Health Ralph Lieto St. Joseph Mercy Health System Melissa Martin Therapy Physics Jeff Norenberg National Association of Nuclear Pharmacies (NANP)
Francis ONeill State of Vermont Michael Peters American College of Radiology Craig Piercy Bose Public Affairs on behalf of NANP Carmine Plott Novant Health Aria Razmaria UCLA Medical Center Gloria Romanelli American College of Radiology Joseph Rubin MWW on behalf of UPPI Michael Sheetz University of Pittsburgh School of Medicine Cindy Tomlinson American Society for Radiation Oncology John Witkowski United Pharmacy Partners (UPPI)
Maryann Ayoade NRC/NMSS/MSST/MSEB Lisa Dimmick NRC/NMSS/MSST/MSEB Christian Einberg NRC/NMSS/MSST/MSEB Jennifer Fisher NRC/NMSS/MSST/MSEB Ed Harvey NRC/NMSS/MSST/MSEB Esther Houseman NRC/NMSS/OGC Donna-Beth Howe NRC/NMSS/MSST/MSEB Janelle Jessie NRC/COMM/OCMJB Sarah Lopas NRC/NMSS/MSST/MSEB Joan Olmstead NRC/NMSS/MSST/FSTB Katie Tapp NRC/NMSS/MSST/MSEB ENCLOSURE