ML19002A566
| ML19002A566 | |
| Person / Time | |
|---|---|
| Issue date: | 12/11/2018 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB |
| To: | |
| Sarah Lopas | |
| References | |
| NRC-0001 | |
| Download: ML19002A566 (84) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Public Meeting to Accept Comments on the NRC's Evaluation of Training and Experience Requirements for Different Categories of Radiopharmaceuticals Docket Number: (n/a)
Location: Rockville, Maryland Date: Tuesday, December 11, 2018 Work Order No.: NRC-0001 Pages 1-84 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
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PUBLIC MEETING TO ACCEPT COMMENTS ON THE NRC'S EVALUATION OF TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
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TUESDAY, DECEMBER 11, 2018
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ROCKVILLE, MARYLAND
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The meeting convened in the Commissioners' Hearing Room at the Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, at 1:00 p.m.,
Joan Olmstead, NRC Facilitator, presiding.
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2 NRC STAFF PRESENT:
JOAN OLMSTEAD, NRC Facilitator SARAH LOPAS, Project Manager, Office of Nuclear Material Safety and Safeguards MARYANN AYOADE, Health Physicist, Office of Nuclear Material Safety and Safeguards CHRISTIAN EINBERG, Chief, Medical Safety and Events Assessment Branch, Office of Nuclear Material Safety and Safeguards JENNIFER FISHER, Office of Nuclear Material Safety and Safeguards*
ALSO PRESENT:
JANICE CAMPBELL*
RALPH LIETO, St. Joseph Mercy Health System*
ARIA RAZMARIA*
JOE RUBIN, United Pharmacy Partners JEFF NORENBERG, National Association of Nuclear Pharmacies JOHN WITKOWSKI, United Pharmacy Partners*
- Present via teleconference NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 C O N T E N T S Page Welcome and Introduction...........................4 Review Agenda and Ground rules.....................7 General Meeting Information........................9 Presentation on the NRC's T&E Evaluation..........12 Current Evaluation Efforts........................18 Questions.........................................23 Comments..........................................31 Thank you and Adjourn.............................84 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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4 1 P R O C E E D I N G S 2 1:04 p.m.
3 MS. OLMSTEAD: Good afternoon. Welcome 4 to the Nuclear Regulatory Commission's webinar to 5 accept comments for the staff evaluation of training 6 and experience requirements for different categories 7 of radiopharmaceuticals.
8 My name is Joan Olmstead. And I'll be 9 facilitating today's meeting. I am joined here at the 10 NRC's headquarters by Chris Einberg, who is staff of 11 -- Chief of the Medical Safety and Events Assessment 12 Branch.
13 And Sara Lopas, a member of the Medical 14 Radiation Safety Team, and project manager for the NRC's 15 training and experience evaluation. And Maryann 16 Ayoade, who is a Health Physicist on the NRC's Medical 17 Radiation Safety Team, and the technical lead on the 18 training and experience evaluation.
19 This is a Category Three public meeting 20 to encourage active participation and information 21 exchange for the public. The NRC staff will provide 22 information on our current evaluation efforts, and then 23 solicit comments on what could be potential issues that 24 should be considered in the Commission paper being 25 prepared on this topic.
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5 1 I'd like to go over some logistics before 2 we start the meeting. Hopefully everyone has signed 3 in and received copies of the handouts, the presentation 4 slides, the August 18 training and experience 5 information paper that was developed for the 6 Commission, and the training and experience Federal 7 Register Notice that was published on October 29, 2018.
8 If you haven't signed in, the sheets are 9 near the handout table by the left entrance to this 10 room. For those of you on the phone who haven't signed 11 in, please contact Sarah Lopas to ensure that we have 12 your contact information.
13 You can get Sarah's contact information 14 from a slide that the NRC staff are about to present.
15 And also from the public meeting announcement.
16 All web conferencing participants that 17 wish to ask questions or give comments, can type them 18 into the webinar if they would like. People on the 19 teleconference line can also tell the Operator that 20 they would like to ask questions or give comments by 21 pressing star one on their telephones.
22 The Operator will be putting the 23 teleconference on mute and form a queue for 24 participants. I'll make sure to ask the Operator if 25 there are people that have comments during our comment NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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6 1 period.
2 This meeting is being transcribed. So in 3 order to get a clean transcript and minimize 4 distractions during the meeting, we'll ask that you 5 turn off or mute anything that rings, buzzes, beeps 6 or alarms.
7 For folks on the phone, please put your 8 phone on mute unless you're speaking. Please try to 9 minimize loud side conversations. We'll try to have 10 only one speaker at a time.
11 When speaking, please use the microphone 12 so people on the phone can hear you. We have two standup 13 microphones and one handheld microphone that I can bring 14 to you if you would prefer to stay seated during your 15 comments.
16 Restrooms are out this door, the one on 17 the left door. And then when you go in the hallway, 18 it's on the left. If we have to evacuate, please 19 follow directions from the security officers.
20 Are there any questions about the 21 logistics?
22 (No response.)
23 MS. OLMSTEAD: Okay. Next slide, please.
24 After the welcome, Sarah Lopas will go into some more 25 detailed information for the webinar participants.
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7 1 And Maryann Ayoade will give a presentation 2 about the current training and evaluation regulations, 3 and NRC's evaluation process.
4 After that we'll have a comment period, 5 which will also include seeking comments on particular 6 questions that were raised in the Federal Register 7 Notice.
8 We'll be taking a short, ten minute break 9 beginning maybe between 2:00 and 2:15 p.m. When we 10 break, we will ask that those of you participating 11 remotely, stay on the phone line and stay logged into 12 the webinar.
13 Chris Einberg, Chief of the Medical Safety 14 and Event Assessment Branch will start us off with a 15 short welcome and the purpose of today's meeting. I'll 16 now hand the meeting over to Chris.
17 MR. EINBERG: Thank you Joan. Good 18 afternoon everyone. Thank you for taking the time to 19 attend today's meeting both in person and on the 20 webinar.
21 Today's meeting is the second of the four 22 comment acceptance meetings that the NRC will be 23 conducting on our training and experience requirements 24 evaluation.
25 The purpose of today's meeting is twofold.
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8 1 First, to provide background information on the NRC 2 Staff's planned evaluation of developing tailored 3 training and experience requirements for administering 4 different categories of radiopharmaceuticals, from 5 which a written directive is required in accordance 6 with our regulations in 10 CFR, Part 35.
7 Which are our regulations for the medical 8 use of byproduct material in Subpart E, under Part 35, 9 which covers unsealed byproduct material written 10 directive required. And most importantly listen to 11 and record your comments on the evaluation.
12 The comments we receive from the medical 13 community, the agreement states, and other 14 stakeholders, are critical to the NRC staff's decision 15 in making -- to the NRC staff decision making on whether 16 our existing training and experience requirements 17 should be revised.
18 If you do not provide your comments today, 19 we encourage you to participate in one of our future 20 comment meetings in January. Or submit written 21 comments using the Regulations.gov by January 29, 2019.
22 Later in the presentation we will cover 23 how you can submit your written comments. And now I'll 24 hand the presentation over to Sarah Lopas.
25 MS. LOPAS: Hi everybody. I'm going to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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9 1 -- and so Chris's welcome, thank you for taking the 2 time to be here today.
3 So for folks on the phone, if you aren't 4 logged into the webinar that's okay. Because you can 5 still access our slides. They are posted on our Meeting 6 Notice.
7 So, if you go to Google and you Google NRC 8 Public Meeting, the first result that will pop up will 9 be the NRC's Public Meeting Schedule website. If you 10 click on that link, it will take you to the meeting 11 schedule webpage.
12 And one of the first couple of meetings 13 listed is this meeting, the training and experience 14 meeting. If you click on more, then scroll down, you'll 15 see a link to our slides.
16 And also, if you were registered for the 17 webinar, you should have gotten a reminder email at 18 about 12:00 p.m. Eastern. And in that reminder email, 19 there was a link to our slides as well.
20 So, also for logged into -- if you are 21 logged into the webinar, I have uploaded a few handouts 22 on the right-hand side of your webinar under the handout 23 tab.
24 You can find the same handouts that we have 25 here in the room. So that's our information paper that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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10 1 we created for the Commission back in August 2018.
2 We also have the Federal Register Notice.
3 And then we also have the slides for today. So you 4 can download those onto your computer if you're on the 5 webinar.
6 And of course folks here in the room, feel 7 free to grab those copies here now or on your way out.
8 So, today we're going to be discussing the 9 NRC's evaluation of our -- of training experience 10 requirements for certain categories of 11 radiopharmaceuticals. And so we're often going to 12 refer to training and experience as T&E.
13 And then similarly, we will refer to 14 authorized users, i.e., those physicians who are 15 authorized to administer radiopharmaceuticals as AUs.
16 So AUs and T&Es are what you'll hear for short a lot 17 of times today.
18 As we mentioned, today's webinar is being 19 transcribed by a court reporter. So, we will have a 20 full transcript of today's meeting available for you 21 in a couple of weeks in our Agency-wide Document Access 22 and Management System, or ADAMS as I'm sure you're 23 familiar with.
24 And I'll be posting a link to that 25 transcript on our training and experience website.
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11 1 So, all the information from the meeting we have on 2 November 14, you know, an identical webinar on November 3 14, I've already posted that meeting summary and 4 transcript, and slides from that meeting on that 5 website. So the same thing will happen for this meeting 6 and future meetings.
7 All the comments today are going to be 8 captured on the T&E docket. So we'll be combing through 9 the transcript and pulling out your comments and your 10 questions for inclusion in our evaluation effort.
11 And if you speak a comment today, you don't 12 necessarily need to repeat it again, then submit it 13 written on the -- via regulations.gov. I mean, you 14 can certainly if you want.
15 But, there is no difference. We treat the 16 comments the same whether you speak them over the phone, 17 or you submit them via the webinar and I read them aloud, 18 or you stand up and use the microphone today. There's 19 no difference.
20 So, we will be opening the phone lines after 21 the NRC presentation for comments. And we'll be going 22 to folks in the room for comments.
23 And as a reminder, the folks on the phone, 24 you're in listen only. And you're just going to have 25 to press star one to make a comment.
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12 1 And so now I'm going to go to Maryann 2 Ayoade. She's our health Physicist. And she's the 3 technical lead on our project. And she'll give you 4 some additional background on what we're doing here.
5 MS. AYOADE: Great. Thank you Sarah. So 6 today I will be presenting information on an overview 7 of the Regulations on training and experience for 8 radiopharmaceuticals that require a written directive, 9 some background information on the related stakeholder 10 concerns that we have received thus far for this 11 evaluation, and NRC's efforts on the evaluation this 12 far.
13 So the current NRC Regulations on training 14 and experience for radiopharmaceuticals requiring a 15 written directive are under 10 CFR, Part 35, Subpart 16 E.
17 These training and experience requirements 18 provide three pathways that a physician maybe 19 authorized to administer radiopharmaceuticals that 20 require a written directive.
21 A physician can be authorized to administer 22 these radiopharmaceuticals if they're certified by a 23 medical specialty board whose certification process 24 is recognized by the NRC or an agreement state.
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13 1 satisfy the training and experience requirement via 2 an alternate pathway, which includes the completion 3 of seven hundred hours of training and experience.
4 Including a minimum of two hundred hours of classroom 5 and laboratory training in the relevant topic areas 6 as listed in the Regulations. And, five hundred hours 7 of supervised work experience in the relevant areas 8 as listed in the Regulations.
9 And a physician can also be authorized if 10 they are -- if they have been previously identified 11 as an authorized user of NRC or agreement state license 12 or permit.
13 For this training and experience 14 evaluation is focused on the ultimate pathway. And 15 NRC staff are looking into what tailored training and 16 experience requirements for a limited authorization 17 and limited administration of certain categories of 18 radiopharmaceuticals would look like.
19 And that is what we will be referring to 20 as a limited authorized user status. Next slide.
21 In Subpart E there are four sections that 22 pertain to training and experience requirements. The 23 first section is under 10 CFR 35.390.
24 And that is for the training for the use 25 of all radiopharmaceuticals in Subpart E. All of which NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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14 1 require a written directive.
2 The second is under 10 CFR 35.392. And 3 that is for training for oral administration of sodium 4 iodide, iodide-131, requiring a written directive in 5 quantities less than or equal to 33 millicuries.
6 The third is under 10 CFR 35.394, to train 7 for oral administration of sodium iodide, iodide-131, 8 requiring a written directive in quantities greater 9 than 33 millicuries.
10 And the fourth section is under 10 CFR 11 35.396 for training for the parenteral administration 12 of any radiopharmaceutical requiring a written 13 directive.
14 And I want to point out that all of these 15 sections are training and experience, including the 16 pathway for experienced authorized users already listed 17 on a license.
18 Also, all the Sections except 10 CFR 35.396 19 include training and experience under the board 20 certification and alternate pathways. However, 10 CFR 21 35.396 is for training exclusively under the alternate 22 pathway.
23 And it really is for the radiation 24 oncologists that are looking to become authorized 25 users. And they can do this by completing some NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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15 1 additional hours of training and experience.
2 I also want to point out that the alternate 3 pathway under 10 CFR 35.392 and 394 is for the physician 4 to successfully complete 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and lab 5 training that is relevant to the type of use for which 6 they are seeking to be authorized.
7 Whereas the ultimate training pathway 8 under 10 CFR 35.390 is for the physician to successfully 9 complete seven hundred hours of training and 10 experience, which includes two hundred hours of 11 classroom and laboratory training. Next slide.
12 This slides some background information 13 on stakeholder concerns with these related to these 14 training and experience requirements.
15 Since the revision to the training and 16 experience requirements in 2002 and again in 2005, 17 stakeholders have raised concerns about the effects 18 of some of the requirements of patient access to certain 19 therapeutic pharmaceuticals.
20 Specifically, some stakeholders have 21 asserted that the seven hundred hour requirement in 22 10 CFR 35.390 is overly burdensome for physicians who 23 are not certified by medical specialty boards.
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16 1 thereby limits patient access to certain 2 radiopharmaceuticals.
3 And so as a result, in 2015 and '16, in 4 separate efforts, the NRC staff and the NRC's Advisory 5 Committee on the Medical Uses of Isotopes, which is 6 the ACMUI, independently reviewed the training and 7 experience requirements for the medical uses authorized 8 under Subpart E.
9 Specifically, the NRC staff reviewed the 10 regulatory basis and comments that were received on 11 past rulemakings that were related to the medical use 12 of byproduct materials. And did not identify any new 13 information that would call into question the basis 14 of the existing requirements.
15 As a result, the NRC staff did not propose 16 any changes to the regulation at that time. And the 17 NRC staff is continuing to work with ACMUI on this 18 ongoing training and experience evaluation effort.
19 Next slide.
20 As part of the staff requirement's 21 memorandum dated August 17, 2017, and that information 22 is publically available in ADAMS in the hyperlink that's 23 referenced on this slide.
24 The Commission directed the NRC staff to 25 evaluate whether it makes sense to establish tailored NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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17 1 T&E requirements for different categories of 2 radiopharmaceuticals.
3 To evaluate how those categories should 4 be determined, such as by risks posed by groups of 5 radionuclides, or by delivery method to determine what 6 -- to evaluate what the appropriate training and 7 experience requirements would be for each category.
8 And to evaluate whether the requirements 9 should be based on hours of training and experience, 10 or focus more on competency. Next slide.
11 In response to the Commission direction, 12 the NRC staff solicited feedback from some medical and 13 regulatory stakeholders in April and May 2018. That 14 evaluation including the NRC staff analysis and the 15 feedback that was received of the training and 16 experience requirement in Subpart E of 10 CFR Part 35, 17 that was documented in SECY-18-0084.
18 And the results of the evaluation concluded 19 that it maybe be feasible to establish tailored training 20 and experience requirements for different categories 21 of radiopharmaceuticals. And to create a means of 22 authorizing the administration of certain categories 23 of radiopharmaceuticals, which is the limited 24 authorized user status.
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18 1 options for creating a competency-based approach to 2 demonstrate acceptable training and experience for a 3 limited authorized user status.
4 But however, the staff needs to conduct 5 more extensive outreach to stakeholders in the medical 6 community, to the agreement states, and to other members 7 of the public before making any recommendation to the 8 Commission.
9 And this brings us to our current 10 evaluation to date. So, I will now hand over back to 11 Sarah, who will be discussing our current evaluation 12 efforts, and how you can participate.
13 MS. LOPAS: Thank you Maryann. So, the 14 end product of our evaluation is going to be a paper 15 that we're going to send up to our five member 16 Commission.
17 And that paper will either document our 18 reasoning for recommending no changes to the T&E 19 requirements, or if we do recommend changes to our T&E 20 regulations, if we conclude that these changes are 21 warranted, we will document our reasoning and our plan 22 for rulemaking in what we call a rulemaking plan paper.
23 This is a simplified diagram on this slide.
24 The information that we're going to consider in our 25 development of a recommendation to the Commission on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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19 1 whether changes to our existing T&E regulations are 2 required.
3 The diagram -- this diagram illustrates 4 why this comment period is so important. Because in 5 a large part, the feedback that we receive on the 6 questions that we've asked in the Federal Register, 7 are going to inform our recommendation to the 8 Commission.
9 So, other important feedback that will also 10 come from our coordination with our co-regulators, the 11 agreement states, and the NRC's ACMUI, the Advisory 12 Committee on Medical Use of Isotopes.
13 In addition to the input that we received 14 from the public, medical stakeholders, the agreement 15 states, and the ACMUI, the NRC is going to examine the 16 issue of patient access.
17 So our staff is going to determine -- is 18 going to attempt to determine the number of current 19 authorized users and their geographic distribution 20 across the United States.
21 An authorized user and associated 22 geographic location data is not quite easily and readily 23 available, so we're spending the next month or so 24 pulling that data together from our web-based licensing 25 system, and putting that data set together.
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20 1 So, staff is also going to be reviewing 2 training and experience requirements in other 3 countries, in an effort to benchmark the U.S. against 4 international medical regulations.
5 And then the third piece that we're going 6 to look at is, we're going to do a review of medical 7 and radiation safety events to see if any of those have 8 a nexus to training and experience.
9 And it's important to note that if staff 10 does end up recommending a rulemaking, which we would 11 again, document in a rulemaking plan, the Commission 12 would then proceed to the vote on that rulemaking plan.
13 And that would determine whether or not the staff would 14 proceed with the Part 35 rulemaking effort.
15 If rulemaking is recommended and approved 16 by the Commission, that would start the NRC's extensive 17 rulemaking process. Which I'm sure you're all 18 painfully familiar with, right?
19 So, I wanted to highlight that process 20 information. Because I think it's important that 21 everybody understands where we are at this point in 22 time with this process.
23 And where we are is that we're still in 24 the information gathering stage, to help us determine 25 whether rulemaking is even warranted at this point in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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21 1 time.
2 So, I hope -- I hope at this point folks 3 have read it. But our Federal Register Notice was 4 published on Monday, October 29.
5 And that Federal Register Notice can be 6 accessed via the link on this slide. Or you can also 7 Google the citation. Which is 83 FR 54380. And it 8 will pop up at the top of the search results.
9 So the Federal Register Notice, it 10 announced our public comment period, which ends on 11 January 29, 2019. It announced the dates for these 12 public meetings and webinars.
13 And I'm going to talk a little bit about 14 the remaining meetings we have. But most importantly, 15 the Federal Register Notice asked a series of questions 16 on which we would like medical community, stakeholder 17 input.
18 And I'm going to take a moment to just read 19 through those questions right now. I'm just kind of 20 going to buzz through them. And it's more to give 21 everybody a context of what the information that we're 22 looking for.
23 When we do get to the comment portion of 24 the meeting momentarily, you know, I'm going to open 25 it up for general comments. And everybody can make NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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22 1 their general statements.
2 And then depending on time, and interest, 3 I will attempt to maybe walk us through some of the 4 more specific areas, the more specific questions to 5 see if I can draw out some additional information on 6 top of maybe some of the general statements that we're 7 going to get from folks today.
8 Okay. So, the first set of questions, 9 extensively covers the crux of what we're evaluating.
10 Whether the NRC should create a tailored training and 11 experience requirements for certain categories of 12 radiopharmaceuticals.
13 So, A1, are the current pathways for 14 obtaining AU status reasonable and accessible? Are 15 they adequate for protecting public health and safety?
16 A2, should the NRC develop a new tailored 17 T&E pathway? What would be the appropriate way to 18 categorize radiopharmaceuticals for tailored T&E 19 requirements?
20 A3, Should the fundamental T&E required 21 of physicians seeking limited AU status need to have 22 the same fundamental T&E required of physicians seeking 23 full AU status?
24 A4, how should the requirements for this 25 fundamental T&E be structured for a specific category NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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23 1 of radiopharmaceuticals?
2 The next set of questions focuses on the 3 NRC's recognition of medical specialty boards. So the 4 NRC procedure for recognizing these boards is located 5 on our medical uses licensing toolkit website. Which 6 I hope that folks are familiar with.
7 So, our first question is, what boards, 8 other than those already recognized by the NRC, could 9 be considered for recognition for medical uses under 10 10 CFR 35.300.
11 And the second question, B2, are the 12 current NRC medical specialty board recognition 13 criteria sufficient? If not, what additional criteria 14 should the NRC use?
15 The next set of questions, the third set 16 of questions focuses on patient access to nuclear 17 medicine.
18 C1, is there a shortage in the number of 19 AUs for medical uses under 10 CFR 35.300? And if so, 20 is the shortage associated with the use of a specific 21 radiopharmaceutical?
22 C2, are there certain geographic areas with 23 an inadequate number of AUs?
24 C3, do current NRC regulations on AU T&E 25 requirements unnecessarily limit patient access to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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24 1 procedures involving radiopharmaceuticals?
2 And C4, Do current NRC regulations on AU 3 T&E requirements unnecessarily limit research and 4 development in nuclear medicine?
5 And the last set of questions was just 6 asking for more general input or opinions on the NRC's 7 regulation of training and experience in general.
8 So, the first question was, should the NRC 9 regulate the T&E of physicians for medical uses?
10 Second question, are there requirements in the NRC's 11 T&E regulatory framework for physicians that are 12 non-safety related?
13 And the third question, how can the NRC 14 transform its regulatory approach for T&E while still 15 ensuring that adequate protection is maintained for 16 workers, the general public, patients, and human 17 research subjects.
18 So those are the questions that we've asked 19 in the FRN. And we are hoping to get some feedback 20 on.
21 So how can you submit your comments or 22 respond to these questions? Well, in addition to 23 speaking during today's meeting, and during the 24 additional meetings we have scheduled in January, which 25 are January 10 and January 22, you can also just provide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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25 1 written comments via regulations.gov.
2 And this link in this slide, the direct 3 comment submission link, that will get you right to 4 the comment submission portion of the T&E docket. And 5 you can either upload a comment, you know, a Word 6 document or a pdf, or kind of anything along those lines, 7 or you can type directly in the text box.
8 I just want to note that at the NRC I have 9 immediate access to those comments as they're like 10 submitted via regulations.gov. But there is a little 11 bit of a lag time due to processing we do here at the 12 NRC, where you won't be able to see your comments 13 immediately.
14 I won't get into the details. But, you 15 won't see your comments immediately, but I will get 16 them immediately. And we work to get them up there 17 as quickly as we can, back up on regulations.gov.
18 So you should be able to see other folks 19 comments up there as well. We -- right now I will be 20 honest, we have only submitted -- we only have six 21 comments up there.
22 We've only had six written comments 23 submitted so far. But, I actually -- I have also posted 24 on that T&E docket the transcript from the November 25 14 meeting as well, so.
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26 1 If you encounter any issues with 2 regulations.gov, just email me. And I can help you 3 out.
4 And at the end of this public comment 5 period, we will be compiling all the comments that we 6 receive, both written and oral, and we'll be publishing 7 them in one easily accessible comment reports.
8 And that comment report will not only, you 9 know, lift out all the comments received, but it will 10 also summarize the input that we receive. So, that 11 comment report, that's going to be available on the 12 NRC's T&E website.
13 And we are going to -- also, we'll make 14 sure it's posted to the regulations.gov docket. And 15 we will probably reference that heavily in our 16 Commission paper.
17 And it's important to note that because 18 this is in a rulemaking, that the purpose of collecting 19 your comments is to help inform us. So, we aren't going 20 to be responding to individual comments like you would 21 kind of see in a rulemaking.
22 Or if anybody's seen how we respond to 23 comments like in an environmental impact statement.
24 It won't be like that. We're simply intaking comments 25 at this point.
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27 1 So we have two more public meetings, 2 January 10 that's going to be -- January 10 and January 3 22.
4 January 10 is similar to this meeting where 5 it's a webinar, but it's also in person. And that will 6 be over in our Three White Flint building across the 7 street on -- across Marinelli by the other Metro.
8 And then January 22 will just be one last 9 chance. It will be a two-hour webinar again to just 10 kind of capture any last comments.
11 And again, all those details are on our 12 public meeting website.
13 So just briefly, I'll cover our next steps.
14 After the comment period ends on the 29th of January, 15 we're going to begin organizing and evaluating all the 16 comments that we've heard from everybody.
17 And the NRC still will also, right now and 18 into that period, we are working on conducting that 19 additional research that I noted earlier. Doing that 20 additional work involving, you know, looking at patient 21 access, international bench marking to see what other 22 countries are doing, and then assessing the medical 23 and radiation safety events.
24 And then the ACMUI Subcommittee on training 25 and experience will provide the NRC a report of their NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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28 1 findings and recommendations regarding the T&E 2 requirements, sometime in the spring of 2019, like in 3 March 2019.
4 And the NRC staff is going to consider that 5 as well, their input as well in developing our draft 6 recommendations.
7 And then both the agreement states and the 8 ACMUI will have an opportunity to provide their comments 9 on our draft Commission paper when we get that together.
10 And the NRC will consider and incorporate their 11 comments on our draft paper.
12 We'll incorporate that then into our final 13 paper. And that final paper will be going up to the 14 Commission in the fall of 2019.
15 So, for additional information, I just want 16 to point out that we do have this website, our training 17 and experience website. I'm doing my best to keep that 18 updated with everything that you could possibly need 19 on this effort.
20 So, the SECY papers, and anything that we 21 publish or make publically available like our meeting 22 summaries, and the transcripts, and all that good stuff.
23 The T&E docket, that's associated with 24 regulations.gov. So that number, that NRC-2018-0230, 25 that's the docket on regulations.gov.
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29 1 Like I said, probably the best thing about 2 that is you will see all the comments, all the written 3 comments that everybody else has submitted, on 4 regulations.gov. And that's probably the best place 5 to go there.
6 And then of course Maryann and myself are 7 your points of contact. I think if you have technical 8 questions, I would please ask that you contact Maryann.
9 And then if you have more process type questions, I 10 can help you out with those.
11 And I think that's it. I think we can get 12 into comments. We're kind of right on time more or 13 less, 1:33.
14 So, I do want to remind that folks on the 15 phone, so you can go ahead and press star one. I am 16 going to start with comments in the room, because I 17 do want to acknowledge the fact that there are some 18 folks here in the room that did travel.
19 So I appreciate that you guys came out here 20 to the NRC. So we'll start in the room. And we have 21 to use microphones so that folks on the phone can hear 22 and our court reporter can hear.
23 And if you can begin by introducing 24 yourself, I mean, of stating your name clearly. If 25 you have an affiliation that you would like to state, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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30 1 you certainly can. You don't need to provide an 2 affiliation.
3 And I think that's it. So we will just 4 get started. Does anybody want to -- we can either 5 run a mic to you, Joan can run a mic to you. Or you 6 can use a -- use one of the stand mics.
7 Go ahead. Yeah. And folks on the phone, 8 just go ahead and press star one. And we'll check in 9 with you in just a moment.
10 And folks on the phone -- on the webinar 11 as well, you can also submit a comment via the webinar 12 using the question function. And I can read it aloud 13 for you.
14 Okay.
15 MR. RUBIN: Good afternoon. I'm happy to 16 go first. My name is Joe Rubin. I'm appearing on 17 behalf of United Pharmacy Partners, and alliance of 18 83 independent commercial nuclear pharmacies and 19 affiliate nonprofit academic medical center 20 radiopharmacies across the country, which are focused 21 on delivering prepared radiopharmaceuticals for 22 diagnostic, molecular imaging, and therapeutic patient 23 needs.
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31 1 diagnostic imaging and radiotherapy every day.
2 John Witkowski is the President of UPPI, 3 and he's on the phone to help address any questions 4 that may come up in this discussion.
5 The two primary issues I'd like to address 6 today, the first is the geographic distribution of AUs, 7 and the impact that has on patient access to 8 radiopharmaceuticals.
9 And second was how the NRC's regulatory 10 approach can be transformed to ensure that public 11 protection is maintained while expanding access to 12 radiopharmaceuticals, by expanding the role of nuclear 13 pharmacists.
14 Nuclear pharmacies play a vital role in 15 the distribution and administration of alpha and beta 16 emitter therapies to patients across the country. The 17 training to become an authorized user as a nuclear 18 pharmacist, is the same as the training for physicians.
19 The same seven hundred hour requirements.
20 And NPs maybe listed on the radioactive materials 21 license as the AU and radiation safety officer.
22 To help address the likely disparate 23 geographic distribution of authorized users, which is 24 having a detrimental effect on patient care, 25 particularly in rural areas, UPPI urges the Commission NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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32 1 to consider enabling the teaming of onsite nuclear 2 pharmacists and the specialist physician with limited 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> of specific training.
4 This concept, which was previously 5 submitted to the ACMUI committee, would enable the 6 nuclear pharmacist and specialist physician team to 7 fill the AU requirement as it pertains to radiation 8 protection, patient care, and safety.
9 This would enable the specialist physician 10 to handle the patient care aspects of treatment, and 11 the radiopharmacist to handle the radiation safety 12 aspects of the procedure.
13 The team would continue to ensure that the 14 experience and training necessary of the AU is present 15 for the administration of a radiotherapy of a particular 16 procedure.
17 It would dramatically expand the service 18 area for nuclear medical procedures utilizing alpha 19 and beta emitters, protecting patients, and expanding 20 patient opportunities.
21 So first, let me talk a little bit about 22 the role of nuclear pharmacists. Nuclear pharmacists 23 are trained authorized users, but generally have far 24 more radiation safety responsibilities then physicians 25 and others.
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33 1 NPs have responsibility for creating 2 doses, performing quality control of the 3 radiopharmaceutical preparations, handling the 4 radioactive waste of doses dispensed.
5 There are currently more than one thousand 6 licensed authorized user nuclear pharmacists across 7 the country. And unlike physicians, they are spread 8 more broadly across rural markets.
9 Nuclear pharmacists are responsible for 10 receiving and safe keeping of raw nuclear material such 11 as molybdenum-99 generators, and converting the highly 12 radioactive elutions into technetium-99.
13 Nuclear pharmacists must then draw the unit 14 doses into the correct amount of technetium 15 radioactivity required by the physician, or other 16 radiopharmaceutical to make patient ready doses.
17 This step requires sophisticated analysis 18 and understanding of the decay rate of the emitter, 19 the time of day that the procedure will be administered, 20 and the necessary amount of materials that must be 21 available at the time the procedure is administered, 22 to ensure that the patient receives the correct amount 23 in the dose.
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34 1 has not decayed enough, then the patient may receive 2 a stronger dose of radiation then is necessary.
3 Further, nuclear pharmacies like UPPI 4 members, generally create a number of doses in one 5 central location, which are delivered across the 6 geographic area.
7 For example, one UPPI member with labs in 8 eastern and western Florida, distributes more than five 9 hundred unit doses per day across Florida, from 10 Gainesville to Miami and from Ocala to Fort Myers.
11 The nuclear pharmacists know and 12 understand the nuclear safety challenges, preparing 13 many hundreds of doses, and delivering them across such 14 great distances. And how to handle any radiation 15 safety concerns.
16 Let me talk a little bit about the shortage 17 of authorized users. Antidotal and statistical 18 evidence strongly supports the contention that there 19 is a shortage of AUs in rural areas.
20 There appears to be no definitive answer 21 as to whether or not there's a shortage of AUs, or if 22 there's an uneven geographic distribution of AUs across 23 the country. And if so, what that impact on patient 24 care maybe.
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35 1 to look very closely at that. However, antidotal 2 evidence strongly suggests there is a strong regional 3 disparity.
4 And this is having a major adverse effect 5 on rural healthcare. For example, according to the 6 National Rural Healthcare Association, there are 7 critical shortages of physicians in rural communities 8 across the country.
9 The patient to primary care physician ratio 10 in rural areas is 39.8 physicians per 100 thousand 11 people. Compared to 53.3 physicians per 100 thousand 12 in urban areas.
13 In an emergency, rural patients must travel 14 twice as far as urban residents to the closest hospital.
15 The distribution disparity among specialists is even 16 more acute.
17 While there are 263 specialists for every 18 100 thousand citizens in urban areas, that number drops 19 to 30 specialists per 100 thousand residents in rural 20 areas.
21 There's no reason to believe that the 22 distribution of physician AUs is any different than 23 the general distribution.
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36 1 several areas of the country that face acute shortages 2 of AUs. For example, testimony provided by Bayer to 3 the ACMUI, describes in detail the difficulty it is 4 facing in rural Michigan because of a shortage of AUs.
5 So, measuring the actual distribution 6 again, we agree with the NRC and the American College 7 of Radiology that there is a need to find trustworthy 8 data about current active AU populations.
9 The UPPI has submitted to the NRC a Freedom 10 of Information Act request to attempt to help ascertain 11 the number, type, and training and locations of AUs.
12 And we'd love to work with you on fulfilling that, 13 and the process that you guys have undertaken.
14 So here's our partial solution at least, 15 as I mentioned earlier. Allow AU nuclear pharmacists 16 to work in direct concert with the limited trained 17 physician specialists, oncologists, or other 18 specialists in the administration of patient prepared 19 doses.
20 Nuclear pharmacists are authorized users 21 who arguably have more responsibility for radiation 22 safety, handling, use, and transport, then anyone else 23 in the system. They're also on call to rural areas 24 that may not have AU locations as they deliver patient 25 ready doses.
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37 1 This availability gives them far great 2 reach then the current system. Particularly if they 3 are able to team with a limited trained specialist 4 physician to provide patient care.
5 Enabling licensed, trained, responsible 6 nuclear pharmacists to assist the limited trained 7 specialist physician to administer patient ready doses 8 of alpha and beta radiotherapies, would dramatically 9 expand patient access.
10 In other words, instead of reducing the 11 AU training for certain procedures, the Commission 12 could maintain its current AU training standards. And 13 expand the availability of AUs by enabling nuclear 14 pharmacists to work with a limited trained specialist 15 physician.
16 Accompanying our submission, are UPPI's 17 comments from 2016 that first raised this suggestion.
18 We will be submitting a more detailed comment later 19 in this process.
20 We wanted to raise this proposal at this 21 public meeting to give the NRC and other commentators 22 an opportunity to ask questions, and consider this 23 proposal, so that we may help address these questions 24 as part of the RFI process.
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38 1 take any questions.
2 MS. LOPAS: I have one question for you.
3 Do you know -- this is Sarah Lopas. Do you know when 4 you guys submitted that FOIA?
5 Because I'm looking at my coworker and --
6 MR. RUBIN: It was within the last two or 7 three days.
8 MS. LOPAS: Okay. We'll get it soon then.
9 MR. RUBIN: Yes.
10 MS. LOPAS: All right, excellent. Thank 11 you.
12 MR. RUBIN: Thank you. Thank you very 13 much.
14 MS. LOPAS: Okay. Does anybody want to 15 go next in the room? Or should I go to the phones?
16 Okay, I'm seeing some looking around in 17 the room here. So, Candy, do we have anybody who's 18 pressed star one on the phone?
19 OPERATOR: Yes. We do have John 20 Witkowski. Your line is open.
21 MS. LOPAS: Okay.
22 MR. WITKOWSKI: Thank you. I'm the 23 President of UPPI. And Joe Rubin offered our statement 24 there.
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39 1 will be a growth of alpha and beta radiotherapeutic 2 products in the future. That the regulations should 3 consider expansion of these products becoming a greater 4 portion of the therapies available to patients as time 5 moves forward.
6 The process of having a nuclear pharmacist 7 team with a limited trained authorized user medical 8 specialist, such as a medical oncologist, is similar 9 to a dual authorized user situation that has been 10 familiar with the NRC in the past.
11 We think this is an opportunity to reach 12 out to areas where patient populations can better be 13 served, because alpha and beta therapies may require 14 more than a single injection. So if we go for a course 15 of -- and that's radium-223, for a course of therapy, 16 it is six infusions.
17 And to have a patient from a rural area 18 make six trips over many, many months to a location 19 to receive the radiotherapy, when it could be done with 20 a dual authorized user situation, would save the patient 21 a lot of time and expense. And then there would be 22 better follow up to patient care.
23 Thank you.
24 MS. LOPAS: Okay. Thank you very much. So a reminder 25 for folks on the phone, press star-one. And I also NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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40 1 want to just let you know that you can submit a question 2 or a comment to me using the question function on the 3 webinar, and I can certainly read it aloud for you, 4 if you would -- if you would feel more comfortable doing 5 that.
6 Candy, do we have any other questions or 7 comments on the -- on the phone?
8 OPERATOR: We are showing no questions at 9 this time.
10 MS. LOPAS: Okay. Does anybody in the 11 room want to make a general comment or statement?
12 Okay. All right, guys. I'm going to just 13 walk us through some of these questions, and it might 14 be radio silence and that's okay, but I'm going to try.
15 I'm going to try here, and maybe we -- we end our meeting 16 very early, depending on if we just really get no --
17 no input.
18 So here I just want to focus on some of 19 the specific questions that the NRC asked in our Federal 20 Register Notice, because we are looking at -- we would 21 like to get some specific feedback on these questions.
22 It is going to help us develop our paper for the 23 Commission.
24 So here we have these questions about --
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41 1 and experience requirements. And if you open up the 2 FRN, the Federal Register notice, if you have that on 3 -- with you now or if you're on the webinar, that's 4 one of the handouts that I uploaded, we actually asked 5 a whole bunch of subquestions underneath these 6 questions.
7 So there really are a ton of questions that 8 we could -- we could delve into here, but I'm wondering 9 if anybody has any specific feedback. The last webinar 10 we had, we got some feedback that -- that it would be 11 difficult if the NRC created additional categories for 12 radiopharmaceuticals, that if new -- we got one comment 13 that said that if new radiopharmaceuticals came in and 14 they didn't kind of fit precisely under our categories 15 that then we'd have to figure out where they fit, and 16 that could delay patient access to getting these new 17 -- these new therapies.
18 So that was one comment that we got where 19 somebody was against creating more specific categories 20 for training and experience.
21 And I just want to add another point of 22 thought, just kind of summary of what we heard in our 23 last meeting maybe, and maybe it will jog some -- jog 24 some comments. Somebody did give the point that they 25 thought that some of the more patient-ready doses of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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42 1 radiopharmaceuticals just really did not merit the 500 2 and 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />, so total 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, and then that was 3 adversely affecting patient access.
4 And then a converse point to that was that 5 if we allow physicians to just kind of come in with 6 a limited amount of training, like 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> or whatever 7 it might be, that that wouldn't help advance the general 8 field of -- of nuclear medicine in the United States, 9 that the physician pointed out that nuclear medicine 10 and the advancements and developments in this field 11 of medicine are lagging behind other countries because 12 -- for whatever reason. And that if we just kind of 13 let these specialists come in and just kind of do one 14 thing, and they only do the one thing, and they don't 15 do any advancements in the field, that that wouldn't 16 help the overall nuclear medicine field.
17 So those are some of the -- some of the 18 things. I'm trying to -- a number of things in our 19 last webinar on November 14th, but I don't know if that 20 jogs any comments that folks would have, anybody wants 21 to comment on creating specific categories?
22 Candy, is there anybody on the phone?
23 OPERATOR: Currently, we are showing no 24 questions. Again, for questions or comments, press 25 star-one.
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43 1 MS. LOPAS: All right. Or you can submit 2 a comment via the webinar.
3 We have the fourth question the slide, the 4 fourth part of the questions that we had.
5 Question 5 here, this was the part that 6 had all sorts of -- all sorts of subquestions, so if 7 anybody has any thoughts on this one. We did get some 8 input last time around, but there should be -- the 9 radiopharmaceutical manufacturers should be able to 10 provide preceptor attestation. We did get that input.
11 And feel free to jump up and use a mic.
12 You look like you want to comment. All right. We've 13 got a taker. I like it. I like it. Okay. And 14 star-one on the phone, and we'll come back to you folks 15 on the phone.
16 DR. NORENBERG: Hi. I'm Dr. Jeff 17 Norenberg. I am the Chairman and the Executive 18 Director of the National Association of Nuclear 19 Pharmacies. We are a trade association. Our 20 membership is exclusively comprised of nuclear 21 pharmacies that provide the unit-dose, patient-ready 22 radiopharmaceuticals that are used in diagnostic and 23 therapeutic nuclear medicine, some 35,000 doses per 24 day. About 10 million per -- patients per year are 25 affected by the drugs that flow through the nuclear NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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44 1 pharmacies.
2 Our mission as a trade association is to 3 identify and communicate the best practices in nuclear 4 pharmacy that can ensure patients have access to safe 5 and effective radiopharmaceuticals and thereby improve 6 the quality of medicine that is delivered in the nuclear 7 medicine departments by the customers who we serve.
8 So our feeling on this issue is that all 9 avenues should be explored, that we should identify 10 opportunities to provide greater access to patients, 11 acknowledging the shortages of some of the specialists 12 and practice settings that are often required, which 13 do negatively impact patients and require the need to 14 travel, as a previous commenter alluded to.
15 We are also aware that physicians can play 16 a critical role, and there may be opportunities for 17 enhanced training, additional competencies to be 18 demonstrated, which would improve patient access. So 19 I think were agnostic to -- at this point to the specific 20 remedy, but we do think that patients should have access 21 to the right drugs, the standard of care necessary to 22 alleviate the suffering from the bad diseases that they 23 suffer.
24 And we do believe that the current paradigm 25 has shown us that there are limitations, and some of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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45 1 it is scope of practice and maybe beyond the mandate 2 of this group, but we want to make sure that we balance 3 the needs to ensure public safety and the safety of 4 the occupational workers who participate in these 5 therapies.
6 So our participation today is really just 7 to encourage the dialogue about learning more for 8 specific categories of radiopharmaceuticals, specific 9 routes of administration, unique practice setting 10 requirements that can be identified and resolved 11 through additional opportunities for training and 12 education, leading to competencies that would allow 13 a greater number of patients to receive these vital 14 therapies.
15 And so I think there have been a number 16 of important points made today, and through the written 17 comments there are a lot of thoughtful questions being 18 asked, and I'm glad to see that the NRC is revisiting 19 this issue. I was a little bit -- our members I think 20 were a little bit discouraged by the previous 21 subcommittee dialogue that occurred -- not being broad 22 enough, perhaps ignoring some inputs -- and we're glad 23 to see that this is on the docket and getting a full 24 public treatment, and we look forward to providing more 25 specific information about the training and education NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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46 1 that can be provided.
2 As an aside, my full-time job is I am a 3 professor of radiopharmaceutical sciences and the 4 Director of Radiopharmaceutical Sciences at University 5 of New Mexico.
6 We developed Nuclear Education Online, 7 which is an education and training platform 8 specifically to deliver authorized nuclear pharmacist 9 training. We started in 2000. That program is a 10 web-based program that provides 200 didactic hours, 11 and then we have a -- we work in partnership with 12 training sites, and we have promulgated a training guide 13 which has task-specific, competency-driven exercises 14 that can be effected in a practice setting, and we mentor 15 the preceptors to deliver those 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of tactical 16 experience.
17 Over 25,000 students have participated in 18 courses offered by Nuclear Education Online, not all 19 nuclear pharmacists, but a lot of nuclear 20 cardiologists. We do a lot of training for shippers 21 and receivers of radioactive material, seeking to 22 comply with DOT requirements for training and 23 education. And in that way, the Nuclear Education 24 Online has endeavored to provide a full suite of 25 didactic and experiential components that can serve NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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47 1 a variety of different audiences.
2 And we believe that similar mechanisms can 3 be brought to bear to overcome some of the obstacles 4 that we encountered that led to the formation of Nuclear 5 Education Online to address the needs of pharmacists, 6 nuclear cardiologists, and other workers in this area.
7 Prior to 2000, this education and training 8 was done exclusively onsite. At the University of New 9 Mexico, we have trained over 300 nuclear pharmacists, 10 but not everybody wants to go to New Mexico and spend 11 the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. It's hard to imagine that people 12 wouldn't love to go to New Mexico, but it is a hardship 13 to transplant oneself and to move to that geography.
14 And so we tried to provide an anytime, 15 anyplace, any base, any pace kind of an education 16 platform that could overcome some of those geographic 17 barriers. And, really, we see today more and more 18 education is moving beyond bricks and mortar and getting 19 into more of a just in time, you know, professional 20 adult learning kind of environment. I don't want to 21 throw too much pedagogy, you know, buzzwords at you, 22 but there is a lot of science behind the efforts at 23 online learning.
24 We have grown a lot in the 18 years since 25 this program was launched. We have learned a lot about NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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48 1 the environment, and this has led to our graduates and 2 certificate holders being accepted in virtually every 3 jurisdiction, agreement states, NRC regions, et cetera.
4 And so we have a lot of faith and confidence 5 in our ability to deliver those online and to validate 6 the outcomes that the students' competencies 7 demonstrate, and similar efforts could be brought to 8 bear to overcome the training needs in this area.
9 And so I would just encourage everyone to 10 have an open mind and think about not only historical 11 data but also future opportunities that we have for 12 education and training. And I think we all want the 13 same thing; we all want patients to get those necessary 14 therapies.
15 And whatever the education necessary, if 16 it's 700 or 200 or 80, I'm confident that we can develop 17 high-quality programming and educational opportunities 18 that can satisfy those needs, and we can do it in a 19 -- in a very facile way that can lead to a reproducible 20 outcome and impart competencies that would satisfy the 21 need to balance the protections of the public and the 22 occupational workers with those needs of patient 23 access.
24 So with that, I will stop talking and take 25 any questions that I might have raised.
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49 1 MS. LOPAS: That was great. Thank you.
2 I appreciate that. Do you know how many folks -- I'm 3 just curious how many folks you -- since you started 4 that online training, how many folks have kind of --
5 do they graduate from your program, or how does that --
6 DR. NORENBERG: Yeah. We've had over 400 7 nuclear pharmacists, and we've had some 13 -- 1,300 8 or so radiation workers. We've done a lot of DOT 9 because the frequency of training is every two years, 10 and some employers would like it done every year to 11 overcome any training requirements that DOT might 12 interpret.
13 And then, probably about another 300 or 14 so authorized nuclear cardiologists, COCAPs, sort of 15 changed their model for the pre-qualifications for the 16 exam. So we had a large bolus of those nuclear 17 cardiologists that came through the program about five 18 to seven years ago, but there still are some.
19 And then we provide ongoing opportunities 20 for, you know, nuclear pharmacists. There is 21 about -- as the previous speaker alluded to, there is 22 over 1,000. We like to think there is about 1,700 23 nuclear pharmacists in the U.S., about 1,200 full-time, 24 and every year there is about 100 or more turnover.
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50 1 opportunities. People often move from one practice 2 setting to another. And having the unique skills to 3 work with aseptic processing, radiation safety, and 4 specialized parenterals, a lot of nuclear pharmacists 5 find opportunities to work in hospital or specialized 6 infusion areas, and vice versa.
7 So we see pharmacists that come in and out 8 of nuclear pharmacy throughout their career, and some 9 of them, you know, may need to address the recentness 10 of training requirements. And so we have done a lot 11 of sort of refreshers where people come back and repeat 12 the course because it has been 10 years since they 13 worked in a nuclear pharmacy, or whatever.
14 And so we see, you know, 100 or so people 15 coming into nuclear pharmacy or refreshing their 16 training a year. And I -- I would guess that trend 17 will continue as we see sort of the dynamics of the 18 workforce and the aging population, that there will 19 be a consistent need for slightly more than 100 nuclear 20 pharmacists a year.
21 MS. LOPAS: All right. We've been doing 22 -- Dr. Donna-Beth Howe and Maryann have been doing 23 recent public meetings on our -- changes to our Part 35 24 regulations, which go into effect on January 22, 2019.
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51 1 I'm trying to think of some of the questions 2 that we have been getting about recentness of training, 3 and so that's interesting to hear.
4 MS. AYOADE: Yeah. That's correct. I 5 just wanted to correct for everybody on the record, 6 it's January 14th for the NRC licensees, and for 7 agreement states it's three years from that date, which 8 would be January 14, 2022.
9 MS. LOPAS: All right. Thank you so much.
10 DR. NORENBERG: Thank you.
11 MS. LOPAS: All right. Candy, do we have 12 anybody on the phone, any star-ones on the phone?
13 OPERATOR: We do. We have a question from 14 Janice Campbell. Your line is open.
15 MS. CAMPBELL: Hello. Yes, I have a 16 question. I am a medical physicist specializing in 17 nuclear medicine, and, you know, one of my -- I guess 18 I just want to clarify in my mind, you know, we currently 19 have authorized users authorized to oversee diagnostic 20 radiopharmaceuticals for imaging.
21 And as -- as I oversee these types of 22 programs and do a lot of teaching, I think of those 23 as sort of lower risk radionuclides, and it sounds like 24 -- but, please, you know, clarify for me -- what we're 25 looking at is changing the training and experience NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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52 1 requirements for the higher risk radionuclides, the 2 ones that actually are for treatment.
3 And when I say "higher risk," I guess these 4 are the ones that could, you know, cause harm, that 5 a medical event could occur with.
6 And are we asking for these to be able to 7 be administered in a special practice setting, you know, 8 something like where they would have an independent, 9 you know, license? One of the -- you know, a special 10 license specifically for one radiopharmaceutical, and 11 that specific or special doctor would -- or authorized 12 user would oversee the staff and the safe use of just 13 that radiopharmaceutical? Is that what we're kind of 14 looking at?
15 MS. AYOADE: Yes. So we are evaluating 16 the training and experience requirements for 17 radiopharmaceuticals under Subpart E, which is for the 18 10 CFR 35.300. It is primarily therapy uses and for 19 iodine -- iodine risks.
20 MS. CAMPBELL: So --
21 MS. AYOADE: I mean, greater than 30 --
22 30 microcuries.
23 MS. CAMPBELL: Right. So, in essence, so 24 what I'm saying is correct, we would be --
25 MS. AYOADE: Yes.
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53 1 MS. CAMPBELL: -- requiring these 2 authorized users to have less training than the lower 3 risk diagnostic radiopharmaceuticals.
4 MS. AYOADE: If you -- yes, but we are just 5 evaluating our current training and experience 6 requirements. We are not putting out, you know, any 7 -- anything yet.
8 MS. CAMPBELL: Right, right. No, but I 9 just wanted to make sure that that was part of what 10 we're looking at. And the reason is because there is 11 not enough physician-authorized users in rural areas, 12 and -- but these physicians would have to get their 13 own license, correct?
14 MS. AYOADE: Yes. They would have to get 15 their license to be able to practice in NRC states.
16 MS. CAMPBELL: I see. So they would have 17 -- that would have to be part of their training, I would 18 think. Okay. I just -- I just wanted to clarify, 19 because earlier one of the speakers from UPPI was 20 discussing a lot of the diagnostic doses that are 21 delivered and the difficulty in the regions and 22 geography, et cetera.
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54 1 be overseeing. But it sounds like it's specifically 2 just for the therapies.
3 MS. AYOADE: That's correct.
4 MS. CAMPBELL: Okay. Okay. Thank you 5 very much.
6 MS. LOPAS: Thank you. Thank you for 7 commenting.
8 OPERATOR: Thank you. Again, for 9 questions or comments from the phone, it's star-one.
10 We do have another question on the phone. Ralph Lieto, 11 your line is open.
12 MR. LIETO: Thank you. I am a medical 13 physicist and a former radiation safety officer, and 14 my question is actually -- my first question actually 15 goes back to questions 1 through 3. I thought I 16 understood what the NRC was driving at when they used 17 the term "current pathways for obtaining authorized 18 user status."
19 But now I'm a little -- I think maybe the 20 NRC might need to clarify that because -- and what the 21 previous commenters were saying about nuclear 22 pharmacists, is the intent of the NRC to look at pathways 23 other than licensed physicians obtaining, say, any of 24 the requirements of certain board certification, having 25 certain qualifications, and completing that board NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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55 1 certification?
2 Or are you -- do you intend to make this 3 open-ended? You would have pharmacists that they use 4 providing this administration? Because I could see 5 that this pathway is sort of an open-ended thing. You 6 could have highly qualified nuclear medicine 7 technologists, you know, providing an end-use status 8 qualification that's not going to be a physician.
9 So could you clarify what you mean by "the 10 current pathways"?
11 MS. AYOADE: This is Maryann Ayoade for 12 NRC. When we say "the current pathways," we're looking 13 at the current NRC requirements. So that is for 14 physicians right now.
15 Now, as part of our evaluation, we are, 16 you know, taking comments, and you have received 17 comments, you know, several comments regarding taking 18 a look at pathways for other than physicians. And so 19 that's part of, you know, what we're -- we're going 20 to be looking to use as part of our evaluation.
21 MS. LOPAS: Right. So I think the point 22 is that we are welcome -- we are open to -- to all 23 comments essentially, that we have heard that, that 24 ANPs should be considered. So we're open. We're in 25 this information-taking-in period. So that's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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56 1 something that we are open to hearing as well for sure.
2 MR. LIETO: Okay. So my understanding, 3 that this current pathway was pretty much an open-ended 4 road by which any medical professional with the proper 5 training and experience could become an AU to administer 6 these Part 300 radiopharmaceuticals.
7 MS. AYOADE: Yes, that's correct.
8 MR. LIETO: Okay. My next question goes 9 back to regarding number 5. And, again, you make 10 a -- your clarification from NRC staff. These issues 11 about the requirements for training and experience 12 address the -- what I'll call the radiation safety 13 aspects of the worker training and experience.
14 Is the intent of the NRC to also have some 15 understanding that this must include the clinical 16 patient care aspects and appropriateness of patient 17 care? Which the NRC is pretty clear that they do not 18 regulate.
19 So I'm trying to understand where the NRC 20 has drawn the line between radiation training, safety, 21 and -- radiation safety training and experience, and 22 which it, obviously, it would be an appropriate way 23 to regulate as opposed to the training and experience 24 that is required by getting some type of clinical 25 competency and appropriateness, and so forth, which NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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57 1 they are not supposed to be involved with.
2 MS. AYOADE: So I'm just -- I think I'm 3 trying to understand exactly what your question is.
4 But, again, with this question, just like we said 5 before, we -- and I'm thinking you're referring to the 6 work experience section. You know, we focus on 7 radiation safety as it relates to some of our training, 8 and there is always the talk of, you know, where we 9 draw the line with impinging on the practice of 10 medicine.
11 But, again, for these questions, we -- we 12 want to hear, you know, from the public. We want to 13 hear what you guys think in terms of what you want to 14 see NRC doing for work experience and where we should 15 draw the line. That's something we will consider based 16 on the feedback that we get as we move forward in 17 evaluating this current training and experience 18 requirement.
19 MR. LIETO: Thank you.
20 MS. LOPAS: All right. Thank you.
21 Candy, do we have anybody else on the phone?
22 OPERATOR: We're showing no questions at 23 this time.
24 MS. LOPAS: Okay. Star-one for the folks 25 on the phone, if anybody wants to make a comment in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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58 1 response to anything that you've heard so far today, 2 or talk about something new; that's great, too. Or 3 you can send me something via the webinar software.
4 That's fine, too.
5 Is there anybody in the room here that wants 6 to make any additional comments? Yes, please.
7 DR. NORENBERG: All right. This is Jeff 8 Norenberg. I'm speaking as an individual. Is that 9 better? Sorry. Jeff Norenberg, speaking as an 10 individual.
11 I wanted to fill in some context and perhaps 12 help us understand some of the common features of 13 licensed independent practitioners that are designated 14 through the CFR and recognized by medical boards, 15 pharmacy boards, TMS, and others.
16 The status of the license independent 17 practitioner is granted by virtue of a professional 18 degree and then a state licensure by a medical board 19 or a pharmacy board. And I think that's different than 20 what we see happening for technical personnel that go 21 through a voluntary registration that don't have a 22 national standardization of their training and 23 experiential requirements. It's on a state-by-state 24 basis.
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59 1 consideration of some of the issues that have come 2 forward today. In many states, pharmacists are granted 3 independent prescribing authority to administer 4 vaccinations, do TB testing, birth control, hormonal 5 contraception, and other things that benefit public 6 health. And they do this after receiving training and 7 education and demonstrating competency in a very 8 specific category or task-specific practice setting.
9 In addition to the independent 10 practitioner status that allows prescribing authority 11 without monitoring, a number of states have pharmacist 12 clinicians where pharmacists work under the supervision 13 of a physician to administer the entire spectrum of 14 therapies to diagnose and treat the chronic diseases 15 that require intensive drug management, things like 16 diabetes, HIV, hemophilia.
17 These are things that are treated per 18 protocol that require intensive medication 19 intervention. And as the medication experts that are 20 duly professionally licensed and receive special 21 training, pharmacists are identified as the best 22 resource for many of these patients.
23 So I can't say today that I see the similar 24 cadre available for therapy, but I could engage in their 25 future state, that certainly radiopharmacists today NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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60 1 have the most experience handling 2 radiopharmaceuticals. The volumes and the expertise 3 and the manipulations that they do far exceed any other 4 category of occupational operator in this paradigm we 5 are discussing.
6 And I think, you know, back to my days doing 7 therapy with investigational therapeutic 8 radiopharmaceuticals, we have treated approximately 9 70 patients with investigational therapeutic 10 radiopharmaceuticals, and oftentimes, you know, 11 plumbing is really the key to getting the drug into 12 the patient.
13 And there are -- there are some technical 14 just staff's eye on this that experienced 15 radiopharmacists bring that can overcome potential 16 barriers. This is why most of nuclear medicine today 17 is delivered as patient-ready doses that get 18 administered directly to patients.
19 And so I could see a future state where 20 patient-specific therapies with a dose that is prepared 21 unique to a patient is delivered to a clinic, and then 22 it really becomes a matter of getting it into the patient 23 safely and avoiding untoward occupational exposure.
24 And those are the kinds of things that I 25 think pharmacists have some unique capacity to do.
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61 1 It's not to make treatment decisions, but it's, rather, 2 to effect therapies that have been so directed under 3 the written directive.
4 And so I could see that there are 5 opportunities to overcome some of these barriers 6 through that specialized training, and it should 7 probably be drug or isotope-specific, practice 8 setting-specific, and I think that that's a way where 9 we have a track record of being able to ensure the safety 10 of occupational workers and the public through the 10 11 million doses or so that travel through nuclear 12 pharmacies today.
13 And so I see that there is a lot of different 14 ways we could solve this. There is a bill in Congress 15 right now to amend the Social Security Act and designate 16 pharmacists as providers. That could have some bearing 17 on the practice.
18 But I think from a radiation safety 19 perspective and the health physicists patient control 20 initiative, it is really about controlling exposures 21 to the public, the occupational exposures, and making 22 sure that we don't have untoward medical events that 23 result in reportable errors.
24 And those are the kinds of things that I 25 think we perhaps haven't recognized some of the unique NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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62 1 skills and depth of training that pharmacists have.
2 So however we can solve this, and I'd like to see all 3 powers brought to bear, physicians getting additional 4 specialized training, technical staff improving their 5 competencies, and other nuclear pharmacists and others, 6 radiologists taking more interest in this practice 7 setting.
8 So thank you for that opportunity to 9 provide context. And if there's any questions, I'll --
10 MS. LOPAS: Candy, do we have anybody on 11 the phone? Star-one on the phone.
12 OPERATOR: Thank you. Currently, we're 13 showing no questions at this time.
14 MS. LOPAS: All right. Folks on the 15 phone, star-one. I think since it's 2:16, the comments 16 are kind of coming in slowly, we will not take a break.
17 We will just kind of, you know, push forward, since 18 we will likely be ending early. I don't think we need 19 a break.
20 So star-one on the phone, and let's give 21 folks a few more minutes. And then, in the room, just 22 feel free to raise your hand or jump up. Yes, jump 23 right up.
24 Okay. Let's see, does anybody have any 25 input on our recognition medical specialty boards?
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63 1 I don't know if there is anybody in the medical branch 2 who wants to talk about anything that we're doing.
3 No? I see heads shaking. Okay.
4 Okay. Let's see, and so the patient access 5 issue, I can talk for just a moment on this because 6 I'm working on this. So I will -- full disclosure, 7 you know, right now we are limited with the data that 8 the NRC has, and that data is of the NRC licensees, 9 which is only 13 states. So, and there are limitations 10 to the information that we could ask from our agreement 11 states.
12 So the NRC is starting by looking at the 13 facilities that are licensed to administer 300 drugs.
14 We're mapping those for NRC licensed facilities, and 15 we're also looking at the AUs associated with those 16 licensees. So we will have that information for our 17 13 states where we are -- we are doing the licensing 18 there.
19 So for the agreement states, we do not have 20 that information, but that is kind of an evolving --
21 it's an evolving data set that we are working on. So 22 we are looking at that carefully, but I do want to point 23 out that that is a limitation we have.
24 But we -- we did get a question as to why 25 we were asking this. We got a recent question asking, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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64 1 "Well, don't you have that information at NRC? Why 2 are you asking for that that input in the FRNs?" And 3 we wanted to -- I mean, we are asking this because we 4 want to hear, you know, specifically from folks that 5 may be experiencing the impact. You know, if folks 6 are being negatively impacted, and they think it has 7 to do with our training and experience requirements, 8 we want to hear that. So that's why we're asking these 9 questions.
10 And, for instance, we do know that some 11 stakeholders have given us information on this, like 12 Bayer, and so we're encouraging -- we would like to 13 hear more data from that end. So that's why we're 14 asking about patient access.
15 Candy, can I check in on the phones?
16 Star-one on the phone.
17 OPERATOR: Currently, there is no 18 questions. And, again, yes, as a reminder, it's 19 star-one.
20 MS. LOPAS: Okay. And then, so then this 21 last set of questions, just to provide some context 22 on this and then we'll check in for any more comments, 23 you know, so the NRC in general has been looking at 24 how they are -- how they should potentially transform 25 their regulatory environment to continue to transform NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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65 1 the technology that is going on around us and the changes 2 in our industry that we regulate. So this is kind of 3 our -- our attempt at seeing if we could get any input 4 or opinions from our stakeholders on maybe how we could 5 continue to evolve and change as an agency when it comes 6 to regulating the T&E of physicians for medical uses.
7 So, you know, we did hear a little bit about 8 somebody -- I guess Mr. Lieto or Dr. Lieto mentioned 9 about not impinging on the practice of medicine. So 10 it is a fine line to walk.
11 So let me just check back in the room here, 12 for the folks that traveled, anybody want to make any 13 last comments? I'm getting silent looks here in the 14 room.
15 And, Candy, can I check one last time on 16 the phone?
17 OPERATOR: Yes. We do have Ralph Lieto.
18 Your line is open.
19 MS. LOPAS: Hi, Ralph. Go ahead. Are you 20 there? Ralph?
21 OPERATOR: Sir, your line is open, in case 22 you might have muted your line. Again, Ralph, do we 23 have you on the phone?
24 MR. LIETO: Sorry about that. Yes, I was 25 muted. I just wanted to clarify on the point that you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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66 1 made about collecting the data of users for Subpart 2 E. Did you say you are only going to get it from the 3 non-agreement states? Or that you are also going to 4 include some of the agreement states?
5 MS. LOPAS: So right now the NRC, we only 6 have non-agreement state data at our disposal 7 immediately. There is a couple complicating factors.
8 If we were to go out and ask the agreement states for 9 all this data, it could be a pretty heavy lift, and 10 we wouldn't need to apply for -- it's a little -- it's 11 kind of, you know, government parlance, the Office of 12 Management and Budget clearance information, 13 collection clearance, and that's quite a process.
14 We are going to -- we are working with the 15 Organization of Agreement States. We are in active 16 discussions with them, and we may broach with them if 17 there are states that maintain a database kind of 18 similar to what we do. But if there are states that 19 could kind of easily pull this information for us and 20 give it to us, maybe even if it's just kind of raw and 21 then we kind of sort through it, we will do our best.
22 So, but at the moment, the only data that 23 we can get is NRC licensees. I don't know if -- Chris, 24 if you have anything to add to that.
25 MR. EINBERG: That was a good summary.
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67 1 MS. LOPAS: So, yeah, Ralph, more or less 2 that -- that's the answer. Right now, we only have 3 the 13 states of the licensees that we regulate.
4 MR. LIETO: So are you going to do any type 5 of -- I imagine there is an issue that -- you realize 6 that the largest state is going to be Michigan, and 7 everything else is going to be basically extremely rural 8 areas with few licensees.
9 MS. LOPAS: Right. I mean, I would 10 imagine, I mean, there -- and we don't have -- we haven't 11 pulled the map yet, you know, but we are -- we've got 12 Michigan, Delaware, Vermont, Wyoming. Even though 13 Wyoming is an agreement state, we still have their 14 medical uses. Puerto Rico.
15 I mean, I think we're going to see that 16 this tracks with physician access in general, right?
17 I mean, you can't get brain surgery in a little teeny 18 tiny town. You have to go to a major metropolitan city, 19 right? I think it is going to be a little similar.
20 So I think you're right, and I will say 21 that we struggle a little bit with what to do with the 22 data that we are going to get, the maps that we're going 23 to present. I mean, I think we kind of know what it's 24 going to show us. So then the question will become, 25 well, what -- what do we glean from those maps? So NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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68 1 it's a little tough, but -- I don't know if you have 2 any additional thoughts on that.
3 MR. LIETO: Are you asking me?
4 MS. LOPAS: Yeah, I am. I am. I mean, 5 there is -- I'm mean, that's kind of where --
6 MR. LIETO: You automatically collected 7 the number of licensees that are in each state, and 8 so forth. I kind of agree with one of the commenters 9 before that -- or I think they -- they had asked a 10 question like, don't you have that data already?
11 I think it's something that has been asked 12 a number of times over the last probably two to three 13 years. I would think at least the agreement states 14 would be put on some kind of a request that they start 15 to put this data together because there is obviously 16 a demand for it. And I think it's kind of surprising 17 that you don't have any idea on the number of licensees 18 that are authorized for these high-risk 19 radiopharmaceuticals.
20 I mean, it doesn't have to be, you know, 21 exact, but at least some kind of a distribution, even 22 by the states, who is authorized for this. And it's 23 kind of surprising, that's all. And I think if the 24 intent is not being able to do it in the timeframe of 25 this comment period, I think the agreement states still NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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69 1 should be asked to start to generate that kind of data 2 on a routine basis.
3 I think it -- I think it's quite important.
4 You know, they're going to have future needs also.
5 Just my thoughts.
6 MR. EINBERG: Thanks, Ralph. This is 7 Chris Einberg. So we do collect that -- or we do collect 8 data on the number of licensees on an annual basis.
9 But we don't have the exact location of use for the 10 licensees. So that has been the difference here.
11 You know, as far as, you know, collecting 12 the information in the future, as Sarah pointed out, 13 there is a lengthy Office of Management and Budget 14 clearance process to start collecting that data. But 15 that doesn't preclude us from starting the dialogue 16 with the agreement states, which we have started, and 17 we'll have actually a telecon with them on Thursday.
18 And this is an area of discussion that we 19 plan on discussing with them on how best to collect 20 this data and how -- or do they have this data available, 21 so that we can help map out the authorized users at 22 specific locations for these authorized users. So 23 we're working, but it's a -- it's a work in progress.
24 MS. LOPAS: All right. We've got another 25 comment here in the room. Star-one on the phone.
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70 1 DR. NORENBERG: Hi. This is Jeff 2 Norenberg with the National Association of Nuclear 3 Pharmacies. I just want to comment on nomenclature 4 for a moment. I think it's risky to accept the 5 designation "high-risk radiopharmaceuticals" to create 6 any sort of a nomenclature around that notion.
7 There are specific terminologies that the 8 Institute for Medication Safe Practices uses to 9 designate high-alert medications, high-risk 10 medications, and others. And I think we ought to really 11 be disciplined and stick to that 35.300 definition of 12 radiopharmaceuticals requiring a written directive and 13 avoid the common casual references to other terms that 14 we might want to apply.
15 Thank you.
16 MR. EINBERG: Thank you.
17 MS. LOPAS: Okay. Candy, do we have any 18 other comments on the phone?
19 OPERATOR: Yes. I have a question from 20 Jenny. Your line is open.
21 MS. FISHER: Hello. This is Jenny Fisher 22 from the NRC, and I just wanted to comment, to go back 23 to when we were talking about the different states and 24 to clarify that we're not just regulating the rural 25 states, that we do have a couple of states -- Missouri, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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71 1 Indiana, and Michigan -- and each one of those states 2 have authorized users in the hundreds. So we're not 3 just doing your limited access states as far as NRC 4 regulations.
5 MS. LOPAS: Thanks, Jenny. That's 6 helpful. Yeah. I couldn't think off the top of my 7 head the 13 states that we -- we are looking at.
8 Okay. Candy, is there anybody else on the 9 phone?
10 OPERATOR: We're showing no questions from 11 the phone.
12 MS. LOPAS: Okay. All right. So I'm 13 going to give folks just one more minute -- star-one 14 -- to make any comments on the phone. And while I do 15 that, I just want to close out with just a thought that 16 we -- and I didn't mention this during our last webinar, 17 but we do have meeting feedback forms. They're online, 18 however. They -- if you go to our meeting notice after 19 this meeting closes out, give it a couple hours, like 20 if you go tomorrow, there will be a link for you to 21 provide meeting feedback, and it's online now instead 22 of our old paper and -- you know, paper, put it in the 23 mail thing.
24 And I do remind folks, if you could, if 25 you -- if you could just sign in, if you forgot to sign NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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72 1 in on your way in, that would be helpful for us for 2 my meeting summary.
3 And our comment period closes January 29th.
4 So if you are submitting those official written 5 comments, we ask that you get them in by that date on 6 regulations.gov. If you have any issues, again, you 7 can just email me and I can take your comments as well 8 and get them on the docket.
9 Candy, one last check? Comments on the 10 phone? Questions on the phone?
11 OPERATOR: Thank you. And, again, as a 12 reminder, star-one. I think we do have one in queue.
13 Standby, please.
14 MS. LOPAS: Okay.
15 OPERATOR: We do have a question on the 16 phone. We do not have a name recorded. So if you could 17 press star-on, your line is open for your question.
18 Go ahead, please.
19 DR. RAZMARIA: Hello? Can you hear me?
20 OPERATOR: Yes. Your line is open. Go 21 ahead, sir. And your name, please?
22 DR. RAZMARIA: Hi. How are you? This is 23 Aria Razmaria talking on behalf of nuclear medicine 24 regulator issues. I just kind of thought that, kind 25 of listening to the open public comments today, and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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73 1 I cannot really --- can just offer my -- but I can, 2 basically, just wanted to provide a comment as a 3 physician in training and also in terms of what kind 4 of scope of practice and how the future of nuclear 5 medicine is going to be.
6 Again, I am really perplexed and asked 7 myself, okay, why did I go to medical school where they 8 have more than 10 years of training? And basically 9 they are, you know, training in nuclear medicine in 10 general, medicine in other areas, to be able to provide, 11 you know, professional care of patients. And that's 12 why I was listening to the comments today.
13 So respective of all of the providers that 14 are contributing to patient care in terms of pharmacy 15 technology -- but you kind of have to -- for myself, 16 I think there is a clear delineation of practice. So 17 we -- you heard about, you know, from -- a nuclear 18 pharmacist being able to provide professional, you 19 know, input to the clinic. But, again, what is -- from 20 that point on, what is the clinical decision that is 21 made based on? You know, what is the role of a 22 physician?
23 Again, I don't -- I know I don't want to 24 be --- I have really got to hold myself back and kind 25 of listen to what you are talking about, and, you know, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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74 1 have -- you know, just debate what the pros and cons 2 are. And I kind of just think to myself, okay, you 3 know, if one of my family members needs to have ---
4 be in nuclear medicine study or anything, nuclear 5 therapy, whom do I kind of go to, trust to?
6 And I kind of really -- kind of taken aback 7 by some of the comments or, you know, asking, you know, 8 that this is kind of public, you know, open forum where 9 basically anyone can have these things, which is fine, 10 which is correct, but, again, what is the quality of 11 care that you are looking? What is the future of 12 nuclear medicine?
13 Again, now, if you look outside borders, 14 nuclear medicine in Europe, it has advanced 15 significantly. All these therapies that we are 16 currently talking about that are being able to be 17 admitted to patients have been in the majority of cases 18 coming from Europe, in countries that have a clear 19 nuclear medicine delineation, scope of practice, who 20 work on these therapies and develop in clinical trials 21 and have brought it to fruition. And because of the 22 regulatory framework in these countries, allowing this 23 specialty to thrive and move forward. So I'm just 24 really taken aback by comments made today, with all 25 due respect to all of the teams and groups that are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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75 1 working in the benefit of patients. And it's not about 2 profit, about benefit, it's about patient care and 3 quality of care.
4 And I will ask everybody in the audience, 5 who would you like to send your loved ones to? Who 6 wants to -- what do want to have your loved ones taken 7 care of? Someone who has, you know, access of medicine 8 who is trained in dealing with complications in 9 different areas.
10 These new therapies are not just a simple 11 injection. If you talk about new therapies, this has 12 significant toxicities that come with it, like having 13 chemotherapy administered by someone who is not trained 14 in administering chemotherapies or newer therapies.
15 So it is not trivial, and I think the 16 regulatory framework in the U.S. in the past has caused 17 significant harm and detriment to the field of nuclear 18 medicine. And the discussion that we are having today, 19 everyone seems to want to have a part of the cake, but 20 it is not about this. It's about patient care and the 21 quality of care and some, you know -- some people that 22 are dedicated to taking it forward, not about one 23 pharmaceutical that is now the drug of the future, what 24 other cancers can be treated with radiopharmaceuticals.
25 Again, with respect to all of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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76 1 participants that are taking care of patients and doing 2 their best to provide professional care, but there is 3 an area that, you know -- you know, who has just 4 financial benefit and maximization of profit, which 5 obviously industry is significantly interested in, but 6 not losing, you know, the goal that we have, the quality 7 of care, patient safety in mind.
8 It's not just radiation safety. It's just 9 the clinical expertise in how that patient, what 10 sequence of the therapy is indicated, which, you know, 11 once a radiopharmaceutical therapy fails, what other 12 option is there, in collaboration with oncology, with 13 radiology, with other specialties that are interested.
14 So, again, I am surprised, I do really know 15 that, you know, opening up all training requirements 16 for, you know, the public. You know, I could just, 17 you know, have, for example, my grocery store providing 18 me my, you know, medicine that I need. So it's -- and 19 there is expertise that goes with like pharmacies that 20 can provide professional information about the 21 medicines, the contraindications, or if there is 22 observed side effects.
23 But there is an expertise that comes with 24 the clinical practitioners that have read diagnostic 25 studies, you know, and just are not focusing on one NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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77 1 treatment but know what the imaging aspects that their 2 study looks at, what therapies are indicated in certain 3 scenarios. What radiation dose is there, for that 4 specific tumor burden is indicated.
5 So it is not simple. You know, I am --
6 just listening to the conversation, I am thinking if 7 one of my loved ones needs access to nuclear medicine, 8 whether the U.S. would be the right place to go or 9 another -- go across country, go to Europe, and have 10 it done by, you know, centers that specialize on these 11 type of treatments.
12 And we won't be enhancing future of this 13 type of treatments by opening up -- and specialized 14 therapeutic treatments to, you know, public access.
15 So I know the concern, and I'm really 16 surprised by how NRC is approaching this question with 17 all the respect and all the -- you know, due respect 18 in the field and that the federal agency has. I am 19 kind of really surprised by the approach that is being 20 taken.
21 It is -- it is not a simple -- there is 22 a reason that medical specialties are present. There 23 is a reason that the training program asks for those 24 medical specialties. And all of this discussion and 25 approach that NRC is taking undermines all reasoning NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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78 1 in terms of why these medical specialties are allowed, 2 why there is a medical board of radiology, why there 3 is a board of nuclear medicine.
4 So they have specific training 5 requirements that, you know, involve the clinical 6 expertise and knowledge that is needed for practicing 7 that field. So it is -- the way I perceived this by 8 NRC is opening up, you know, training to -- I mean, 9 don't take me wrong, I am all open for patient access, 10 but the patient access is just meaning, okay, opening 11 up center for cardiothoracic surgery, and, you know, 12 having family practitioners doing that.
13 And I am, as a nuclear medicine person, 14 not able to understand what -- how to do surgery, so 15 this is kind of expertise that a medical specialist 16 would have developed to provide guidance. So I don't 17 -- I just wanted to provide a comment. And I really 18 have tried to hold myself back, but just wanted to have 19 that thought in.
20 And then, just expecting that surprise, 21 how NRC is approaching this and how it is basically 22 really to detriment of a medical specialty.
23 Thank you.
24 MS. AYOADE: This is Maryann Ayoade with 25 NRC. Thank you for your comments. We appreciate that.
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79 1 Just to clarify, again, we are not -- you know, our 2 intention with this evaluation is not because we are 3 moving in any direction right now with making changes 4 to our training and experience requirements.
5 We have had, you know, several public 6 meetings. We have had different people coming in to 7 talk to us about this topic. And so -- and so we have 8 to do our due diligence and taking a look at our training 9 and experience requirements as it relates to 10 radiopharmaceuticals, and that's what we're doing here.
11 And in being open, you know, as part of, 12 you know, what we try to do is we try to share with 13 the public what we're doing. And so part of what we're 14 doing right now is an evaluation process, as Sarah 15 discussed as it relates to patient access, is we are 16 -- we are hearing -- we are taking comments and we are 17 working with the agreement states, and we are looking 18 to see if there are any issues.
19 But this does not conclude or bring -- or 20 say that we are concluding that there is going to be 21 any changes to our regulations, and that we're acting 22 upon it at this moment. We're, again, evaluating what 23 we're doing.
24 And then I just had a question as it relates 25 to -- I believe you talked about some of the different NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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80 1 countries and what they are doing. Do you -- I guess 2 can you tell us some of the countries that you were 3 referring to that have maybe different processes that 4 we might be -- that we should be looking at?
5 DR. RAZMARIA: I can just refer to two main 6 countries where these targeted therapies have been --
7 who have been pioneering this new targeted radiological 8 therapies. One would be Germany, and the other is 9 Australia. In those countries, you see that there is 10 a clear line what requirements are needed in terms of 11 training to be able.
12 And that has -- you know, there is a 13 development -- atomic energy organization that is 14 standardizing what training is needed to be able to 15 practice nuclear medicine. And there is -- one of the 16 countries that has the least command of kind of really 17 minimal is the U.S. So we are lagging behind 18 significantly in terms of, you know, delineating what 19 in fact, training and experience requirements, and just 20 really delineating the minimum.
21 So, and if any -- if anything, there is -- in 22 the U.S., there is a need to increase the training and 23 the clinical expertise. You are focusing so much on 24 radiation safety but there is also the whole vast 25 clinical expertise of using the radiopharmaceuticals NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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81 1 for therapeutic purposes.
2 So, again, the country -- you just need 3 to look to Europe. You just need to open the Journal 4 of Nuclear Medicine, and you can see that, you know, 5 the majority of studies are coming from outside of U.S.
6 And this is really kind of disheartening if you 7 consider that nuclear medicine was in fact developed 8 in the U.S.
9 So this is something that, again, there 10 is a need for people who, you know, just not take, you 11 know, discoveries from abroad and just use it here, 12 but just come forward in developing new therapies for 13 new cancers, new indications.
14 The U.S. has been historically kind of the 15 leading edge of development, and we are just kind of 16 lagging now behind in this area, because I kind of really 17 believe because of the regulatory framework that hasn't 18 really enabled the field of information to thrive.
19 So, again, putting all of the financial 20 benefit to the side, looking at what the future will 21 have, all of the areas of medicine move towards 22 specialization in medicine. So just -- just opening 23 up an area to kind of broad -- well, in our intent we 24 have to always keep in mind patient access, obviously.
25 But patient access to expertise therapy, not just --
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82 1 just someone who is coming in, injecting a therapy and, 2 okay, what are the complications, what are the 3 contraindications, what other steps after the initial 4 therapy are indicated?
5 So just forgetting about all of that, just 6 having that unit dose available, injecting them, okay, 7 we are done. That's not how patient care is done, so.
8 MS. LOPAS: All right. Thank you, Dr.
9 Razmaria. That was -- that was very helpful, and I 10 appreciate that you didn't -- I think you said you were 11 trying to hold back, but I'm glad you didn't.
12 Okay. Candy, do we have anybody else on 13 the line?
14 OPERATOR: We're showing no questions at 15 this time.
16 MS. LOPAS: Okay. All right. Folks, I 17 think -- unless anybody in the room has any last comments 18 that they would want to make? Seeing none, Chris, do 19 you want to close us? No? Okay. I will close us 20 out then.
21 Okay. So our next meeting on here, if you 22 feel like you want to come and spend some time with 23 us again, would be January 10th, and that's the same 24 time, 1:00 p.m. to 4:00 p.m., and it will be webinar 25 and bridge line accessible as well. And then that last NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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83 1 webinar will be on January 22nd, and we will be in 2019.
2 Can you believe it?
3 Okay. Thank you very much, everybody.
4 And I will stay on the bridge line for our court 5 reporter, but thank you, and this concludes our meeting 6 on training and experience. Thanks.
7 (Whereupon, the above-entitled matter went 8 off the record at 2:44 p.m.)
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