ML24176A082
| ML24176A082 | |
| Person / Time | |
|---|---|
| Issue date: | 06/17/2024 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| References | |
| NRC-2869 | |
| Download: ML24176A082 (1) | |
Text
Official Transcript of Proceedings
NUCLEAR REGULATORY COMMISSION
Title:
Meeting of the Advisory Committee on the Medical Uses of Isotopes
Docket Number: (n/a)
Location: teleconference
Date: Monday, June 17, 2024
Work Order No.: NRC- 2869 Pages 1- 76
NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1716 14th Street, N.W.
Washington, D.C. 20009 (202) 234- 4433 1
UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
+ + + + +
ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES
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TELECONFERENCE
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MONDAY,
JUNE 17, 2024
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The meeting was convened via
Teleconference, at 2:00 p.m. EDT, Hossein Jadvar, ACMUI
Chairman, presiding.
MEMBERS PRESENT:
HOSSEIN JADVAR, M.D., Ph.D., Chairman
RICHARD L. GREEN, Vice Chairman
REBECCA ALLEN, Member
ANDREW EINSTEIN, M.D., Member
MICHAEL R. FOLKERT, M.D., Ph.D., Member
JOANNA R. FAIR, M.D., Ph.D., Member
RICHARD HARVEY, Dr.Ph., Member
JOSH MAILMAN, Member
MELISSA C. MARTIN, Member
MICHAEL D. O'HARA, Ph.D., Member
ZOUBIR OUHIB, Member
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MEGAN L. SHOBER, Member
HARVEY B. WOLKOV, M.D., Member
NRC STAFF PRESENT:
LILLIAN ARMSTEAD, ACMUI Coordinator
DANIEL DIMARCO, NMSS/MSST/MSEB
SARAH LOPAS, NMSS/REFS
KATHERINE TAPP, NMSS/MSST/MSEB
ALSO PRESENT:
DAVID BUSHNELL, M.D.
KYLE UNDERWOOD
PAUL WALLNER, M.D., ACR
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AGENDA
Opening Remarks....................................4
Report on Nuclear Medicine Injection
Extravasations as Medical Events..................11
Closing and Adjournment ..........................75
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P R O C E E D I N G S
2:01 p.m.
MR. EINBERG: Okay, if everybody else is
ready, I= m going to go ahead deal with the opening
remarks, and then turn it over to Dr. Jadvar.
So good afternoon. As the Designated
Federal Officer for this meeting, I= m pleased to welcome
you to this public meeting of the Advisory Committee
on the Medical Uses of Isotopes. My name is Chris
Einberg, I= m the Chief of the Medical Safety and Events
Assessment Branch, and I= ve been designated as the
Federal Officer for this advisory committee in
accordance with 10 CFR Part 7.11.
This is an announced meeting of the
committee. It is being held in accordance with the
rules and regulations of the Federal Advisory Committee
Act and the Nuclear Regulatory Commission. This
meeting is being transcribed by the NRC, and it may
also be transcribed or recorded by others.
The meeting was announced in the June 4,
2024, edition of the Federal Register, Volume 89, page
48001.
The function of the ACMUI is to advise the
staff on issues and questions that arise on the medical
use of byproduct material. The committee provides
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counsel for the staff but does not determine or direct
the actual decisions of the staff or the Commission.
The NRC solicits the views of the committee and values
their opinions.
I request that whenever possible, we try
to reach a consensus on the various issues that we will
discuss today, but also recognize there may also be
minority or dissenting opinions. If you have such
opinions, please allow them to be read into the record.
At this point, I would like to perform a
roll call of the ACMUI members participating today.
Dr. Hossein Jadvar, nuclear medicine
physician and chair of the committee?
CHAIRMAN JADVAR: Present.
MR. EINBERG: Mr. Richard Green, vice
chair, nuclear pharmacist?
VICE CHAIRMAN GREEN: Present.
MR. EINBERG: Michael Folkert, radiation
oncologist?
DR. FOLKERT: Present.
MR. EINBERG: Mr. Josh Mailman, patients=
rights advocate?
MR. MAILMAN: Present.
MR. EINBERG: Ms. Melissa Martin, nuclear
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medicine physicist? Melissa, I= m not sure if you had
your mic on or off, but Melissa is present.
MS. MARTIN: I am present. As far as I
know, everything= s on. Melissa is present.
MR. EINBERG: Very good, thank you.
Dr. Michael O= Hara, FDA representative?
I didn= t see him on earlier.
Okay, Mr. Zoubir Ouhib, radiation therapy
physicist?
MR. OUHIB: Present.
MR. EINBERG: Ms. Megan Shober, state
government representative?
MS. SHOBER: Present.
MR. EINBERG: Dr. Harvey Wolkov,
radiation oncologist?
DR. HARVEY: Present.
MR. EINBERG: Dr. Richard Harvey,
radiation safety officer?
DR. EINSTEIN: Present.
MR. EINBERG: Dr. Andrew Einstein,
nuclear cardiologist?
DR. EINSTEIN: Present.
MR. EINBERG: Dr. Joanna Fair, diagnostic
radiologist? Okay, I didn= t see her on earlier.
And Ms. Rebecca Allen --
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DR. FAIR: Present.
MR. EINBERG: Healthcare administrator?
MS. ALLEN: Present.
MR. EINBERG: We have a quorum, so we can
proceed.
So Dr. Joanna Fair recently was selected
as a diagnostic radiologist representative. And she= s
pending for a security clearance and will not have
voting rights for any of the actions requiring a vote,
but may participate in the discussions during today= s
meeting, if she joins us.
DR. FAIR: I am here. This is Joanna
Fair, I am here.
MR. EINBERG: Oh, okay, well thank you.
DR. FAIR: I= m not sure that you heard me
when I said present.
MR. EINBERG: I did not, yeah, thank you
for confirming that, I appreciate that.
Dr. John Engle, interventional
radiologist, consultant to the ACMUI, may participate
in today= s discussion, but does not have voting rights
for any of the actions requiring a vote.
All members of the ACMUI are subject to
federal ethics laws and regulations and receive annual
training on these requirements. If a member believes
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that they may have a conflict of interest as they --
that term if broadly used within 5 CFR Part 2635 with
regard to the agenda item to be addressed by the ACMUI,
this member should divulge it to the chair and the DFO
as soon as possible before the ACMUI discusses it as
an agenda item.
ACMUI members must recuse themselves for
participating in any agenda item for which they may
have a conflict of interest unless they receive a waive
or prior authorization from the appropriate NRC
official.
I would like to add that we are also using
Microsoft Teams so that members of the public and other
individuals can watch online or join via phone. The
phone number for the meeting is 301-576-2978. The
phone conference ID is 558-124-30#.
The handouts and agenda for this meeting
are available on the NRC= s ACMUI public website.
We have several NRC staff members on the
call today. Among them are Lillian Armstead, who is
our ACMUI coordinator; Dr. Katy Tapp; Daniel DiMarco;
and Sarah Lopas.
Members of the public who notified Ms.
Armstead that they would be participating via Microsoft
Teams will be captured as participants in the
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transcript.
Those of you who did not provide prior
notification, please contact Ms. Armstead by email at
LXA5@nrc.gov.Once again, that= s LXA5@NRC.gov at the
conclusion of this meeting.
Today= s meeting is being transcribed by
a court reporter. We are utilizing Microsoft Teams
for the audio of today= s meeting and to view
presentation material in real time. The meeting
material and agenda for this meeting can be accessed
from the NRC= s public meeting schedule.
For the purpose of this meeting, the chat
feature in Microsoft Teams has been disabled. Dr.
Jadvar, at his discretion, may entertain comments or
questions from members of the public who are
participating today.
Individuals who would like to ask a
question or make a comment regarding the specific topic
the committee has discussed and are in the room can
come up to the, well, can raise their hand and indicate
to the Ms. Lopas that they= d like to make a comment.
For those individuals on Microsoft Teams,
please raise your hand. And Ms. Armstead, if you wish
to speak, if you have called into Microsoft Teams using
the phone, please ensure that you have unmuted your
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phone.
When you begin your comment, please
clearly state your first and last name for the record.
Comments and questions are typically addressed by the
committee near the end of the presentation, after the
committee has fully discussed the topic.
We will announce when we are ready for the
public comment period portion of the meeting. And Ms.
Armstead now will assist in the facilitating of the
public comments.
For those who submitted comments prior to
the meeting, those comments will be included with the
meeting transcript.
At this time, I ask that everyone who is
not speaking to please mute your Teams microphones or
phone. And for those in the room, please mute your
phones.
And so I= m going to turn this on over to
Dr. Jadvar. Dr. Jadvar?
CHAIRMAN JADVAR: Thank you very much, Mr.
Einberg. Good morning, or good afternoon as the case
may be, to all. And I hope you all had a great day
yesterday at Father= s Day.
Today in this ACMUI public meeting, we are
going to hear the ACMUI subcommittee= s report on the
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NRC= s staff draft proposed rule and associated draft
implementation guidance for reporting nuclear medicine
injection extravasations as medical events.
With that, I will turn this now to Ms.
Melissa Martin, who served as the chair of the
subcommittee. Ms. Martin?
MS. MARTIN: Thank you, Dr. Jadvar.
It was my privilege to serve as chair of
this committee. This is the report of our subcommittee
on extravasations. Next slide, please.
Our subcommittee members included Dr.
Andrew Einstein, Mr. Richard Green, Dr. Richard Harvey,
myself, and Ms. Megan Shober. And Daniel DiMarco
served as our NRC staff resource. Thank you very much.
Next slide.
We received this -- our subcommittee
received this expanded charge from the U.S. Nuclear
Regulatory Commission staff that the -- we received
the charge to review the NRC Commission staff= s draft
proposed rule and associated draft implementation
guidance for reporting nuclear medicine injection
extravasations as medical events and provide feedback
and recommendations. That was our official expanded
charge. Next. Next slide, please.
This report incorporates several years of
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prior discussions on this topic. In 2019, the ACMUI
revisited the NRC decision to exclude extravasations
from medical event reporting. Was recommended that
extravasations be considered a type of passive patient
intervention.
In 2020, the ACMUI reiterated that
extravasations be considered a time of passive patient
intervention, and that an extravasation that leads to
unintended permanent functional damage be reported as
a medical event under 10 CFR 35.3045(b).
In 2021, the ACMUI supported the reporting
as medical events of extravasations that require
medical attention due to a suspected radiation injury
as determined by an authorized user physician of the
licensee. Next slide.
As background for this report, the NRC
staff has drafted a proposed rule and draft
implementation guidance in response to the Commission=s
direction on the staff= s proposal to codify
requirements of certain nuclear medicine injection
extravasations as medical events. Again, this has
been prepared at the request of the Commission.
The Commission directed staff to codify
requirements for the medical event reporting of
extravasations that require medical attention for a
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suspected radiation injury.
The Commission tasked the staff to explore
approaches that would reduce the reliance on patient
reporting. Next slide, please.
The Commission directed the staff to
evaluate whether the NRC should require licensees to
develop, implement, and maintain written procedures
to provide high confidence that radiation-significant
extravasations will be detected and reported, and to
create guidance to comprehensively explain and
illustrate the medical event reporting criteria for
evaluating and reporting all medical events, not only
extravasation events. Next slide.
So in this preliminary proposed rule
package, the documents include, one, a draft proposed
rule as published in the Federal Register; the draft
implementation guidance, which includes a draft
regulatory guide for the evaluating and reporting of
medical events including extravasation medical events.
Third, it includes a draft model procedures for
detecting and report extravasation medical events.
Next slide, please.
The ACMUI Subcommittee on Extravasations
has a couple of general comments. Number one, the
subcommittee supports the publication of this draft
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regulation and the draft regulatory guide. They are
well-written, and the draft regulatory guide contains
useful information for licensees. So in general, the
subcommittee is very much in support of publishing
these documents. Next slide, please.
For the topics of extravasation and
patient education, the background to this is that the
U.S. Nuclear Regulatory Commission has drafted a model
procedure for management of patients that may have an
extravasation of a radiopharmaceutical.
The current document that covers this is
the draft model procedures for evaluating and reporting
extravasation medical events. It is recognized that
extravasations of radiopharmaceuticals may occur, but
occurrences that may result in a radioactive medical
event are infrequent. Next slide.
Identification of events involving
radiopharmaceutical extravasations are included in
this document, with indications of radiopharmaceutical
extravasations. There is discussion of management of
events involving radiopharmaceutical extravasations,
including discontinuation and resumption of
administration, appropriate notifications, mitigation
strategies, and dose assessments. Next slide, please.
There is document -- there is
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recommendations for event documentation and follow-up
care, including documentation in the patient= s records,
follow-up care for ongoing care and referrals to other
specialties as needed.
There= s recommendations for patient
education, consisting of policies and procedures
consistent with available information from
professional societies. There is patient information
and discharge instructions. Next slide, please.
For specific comments on the proposed
rule. The definition of extravasation: as proposed
in this rule, the NRC defines extravasation to mean
the unintentional presence of a radiopharmaceutical
in the tissues surrounding the blood vessel following
an injection.
The subcommittee believes that this is
overly specific and excludes other possible injection
errors that may occur, such as during intra-arterial
injections, intrathecal injections, as well as
injections intended for a specific body cavity or
space. So the subcommittee= s recommendation is to
broaden the definition of extravasation. Next slide,
please.
Our specific comments on the proposed
rule. If you are reading it or if you read it in the
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future, page 1, we would say this proposed rule would
affect all medical licensees that administer
radiopharmaceuticals for diagnostic and therapeutic
purposes.
On page 5 and page 10, we would like to
expand the definition of extravasation to include
spinal or body cavity into which it was intended
following an injection. On page 11, again, this
proposed rule would affect all NRC and agreement state
medical licensees who administer radiopharmaceuticals
for diagnostic and therapeutic purposes. Next slide,
please.
On page 13, we would like to remove A IV@
from before the work A injection.@ This imposing a
dose-based criterion would require monitoring millions
of administrations per year, which would result in
significant regulatory burden for medical licensees
for only a marginal increase in radiation safety.
The subcommittee agrees with the comment
that in light of the above information on the potential
risk posed by extravasations of radiopharmaceuticals,
the NRC believes such a dose-based requirement would
be inappropriate. Next slide, please.
On page 14, we would insert the word A may@
in the phrase Anormal biological processes may
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transport the dose to the intended target.@
On page 17, we would suggest the following
sentence be removed: A Both radiopharmaceuticals
mentioned are not currently commercially available in
the United States, for example, extravasations from
I-131 iodocholesterol, resulting in erythematous
plaque and Thallium-201.@ That= s the sentence we
would like to have removed because those items are not
used in the U.S. Next page please -- I mean next slide,
please.
On page 20, upon consideration of this
feedback in this proposed rule, the NRC defines the
term Aextravasation@ in Section 35.2 as the
unintentional presence of a radiopharmaceutical in the
tissue around a blood vessel, spinal cord, or body
cavity into which it was intended following an
injection. Next slide, please.
On page 26, we -- the subcommittee agrees
with the comment AThe conclusion from the analysis is
that this proposed rule and associated guidance would
result in a cost to the industry, meaning NRC and
agreement state medical licensees that administer
radiopharmaceuticals for both diagnostic and
therapeutic purposes.@
On page 30, we have the --we agree with
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the question A Who will be required or asked to respond,@
and this is answered by A NRC and Agreement State
licensees who administer radiopharmaceuticals for
diagnostic and therapeutic purposes.@ Next slide,
please.
So we are reiterating extravasation means
the unintentional presence of a radiopharmaceutical
in the tissue surrounding a blood vessel, spinal cord,
or body cavity into which it was intended following
an injection. Next slide, please.
The next document we were asked to comment
on is the draft regulatory guide. And in Section
1.1.1, the subcommittee recommends that a statement
about whether it is reportable if an unintended dosage
was administered and the licensee did not fill out a
written directive when they should have. In other
words, there was no prescribed dosage to be added.
This would address situations where the
administered dose was greater than 20% different from
the intended dose that the physician failed to complete
the written directive. So it our recommendation that
we add a statement about that possibility. Next slide,
please.
In Section 4, instead of referencing the
best practices via -- available through the medical
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library number, we recommend that listing the best
practices explicitly in the regulatory guide as there
are only five short best practices.
Appendix B, add an example of a microsphere
medical event. Next slide, please.
In Appendix B right now, two of the
examples use Lutathera. The subcommittee recommends
limiting that to one example per radiopharmaceutical,
or describing the radiopharmaceuticals generically,
such as a beta-emitting radiopharmaceutical. We don= t
want to imply that all accidents happen -- that happened
use Lutathera. Next slide, please.
The other document we were asked to comment
on is the draft model procedures. Page 1, informed
consent should not be required for either diagnostic
or therapeutic nuclear medicine procedures. That is
the subcommittee= s recommendation.
Patient education, whether done verbally
and/or in printed format, is the appropriate method
of communication between the patient and physician or
healthcare professional. Next slide, please.
Guidelines for observation of unexpected
sensations by the patient or other developments
observed by the medical staff or the patient should
be developed by each facility in accordance with
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recommendations from the professional medical
societies, such as the Society of Nuclear Medicine and
Molecular Imaging, the American College of Radiology,
the American Society for Radiation Oncology, and the
American Association of Physicist and Medicine. Next
slide.
Thank you for your attention, and now we
have time for questions, first from the ACMUI
subcommittee members. I= ll turn this over to Dr.
Jadvar, who will handle the questions.
CHAIRMAN JADVAR: Thank you very much,
Melissa, for that report.
So as Melissa mentioned, this is now open
to the subcommittee members for any comments or
questions regarding this report. I hear none --
MR. OUHIB: This is Zoubir Ouhib.
CHAIRMAN JADVAR: Okay, go ahead.
MR. OUHIB: This is Zoubir Ouhib. I have
a --
CHAIRMAN JADVAR: Are you one of the
subcommittee members?
MR. OUHIB: Yes, this is Zoubir Ouhib.
CHAIRMAN JADVAR: Okay, very good. Go
ahead.
MR. OUHIB: I have questions,
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suggestions, et cetera, for the subcommittee. On page
6, the third sentence, it says, A In that extravasations
are virtually impossible to avoid.@ I was wondering
if perhaps we could say A In that extravasation are not
always predictable and virtually impossible to avoid,@
which is in my opinion is the fact. I mean, we can= t
really predict these.
The last sentence on page 6, it says A Under
Section A, none of these update address extravasation.@
I= m wondering if we can provide a short explanation
for that justification. Why was that not addressed
at all? Perhaps there= s a reason for, you know, the
reader to understand that.
On page 8 under Section 4, the second
paragraph, it says A The Commission directed the staff
to explore approaches to reduced reliance on patient
reporting, etc., etc.@
I am not really sure if that= s a good idea
in my opinion. Because for the majority of the time,
when there are issues on or with any procedures,
including extravasations, it= s the patient that
actually report the unusual item that they=re
experiencing.
You know, we see that in radiation
oncology, whether it= s brachytherapy or radiation beam
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or whatnot. And when there is a mishap, usually the
patient is the first one that actually detect that.
So I would -- I= m sure if that= s a good idea to reduce
the reliance on patient reporting.
On page 10, the first bullet point, it says
ARevising the definition for extravasation to mean the
unintentional presence of radiopharmaceutical, et
cetera, et cetera@ And I was wondering if it= s just
we say the unintentional resulting presence. Because
that basically this is something that happens
afterwards. It= s not already present there.
On page 19, the last sentence under Section
G, it says A All healthcare professional--A oh, my
apologies. I would say to add perhaps, because the
key item there is to really focus on the providing
physician there, whether it= s a nuclear medicine
physician or rad onc, whatnot.
But I think we should add something is that
all healthcare professionals however involved in
patient care are encouraged to communicate with their
staff physician should they identify any unexpected
observation or findings related to extravasation or
anything else, for that matter. So in other words,
not to exclude the rest of the staff completely, because
what I understood, they= re really not sort of per se
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qualifying and leave it to the providing physician.
Page 22, I would -- well, let me skip that
since I= ve got a few. Page 23, the use of the term
Ahigh confidence.@ I= m not sure if it= s needed as it
might lead the reader believe that the rest of the
recommendation are sublevel of confidence.
The slide No. 13, I would suggest changing
patient information to patient education. I= m not sure
what was meant about patient information.
The consent form. I feel very strong
about this, as the informed consent is one of the ninth
core principles of the American Medical Association= s
Code of Medical Ethics.
And if you look at the -- for instance,
just as an example, the APEx, which is the
accreditation, you know, for a radiation oncology
department, the consent form is required. And it= s
a document that the institution is to provide,
basically. If it= s not available, then that= s a
strike.
So I think that= s really very, very
critical, because in that, in the consent form, there
is a discussion regarding the diagnosis. The proposed
treatment plan, the risk and benefit of the plan, which
is there can be discussed at something like this can
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happen or this can happen, etc.
But also provide alternative options in
the consent form. In other words, the patient doesn= t
necessarily have to go through that procedure, and they
can perhaps look into other things.
And then finally of course it= s what happen
if you do nothing. And all that is included in the
informed consent form. And that= s usually signed by
the radiation oncologist.
I can tell you in our practice, we used
to have not only the rad onc, but also the patient,
because you could always have a patient saying nobody
discussed anything with me, I don= t know what you= re
talking about, should there be a problem. But then
if you have a signature, you have a documentation that
these discussion actually took place.
MR. EINBERG: Mr. Ouhib, this is Chris
Einberg from the NRC.
MR. OUHIB: Yeah.
MR. EINBERG: I= m just going to suggest
to you and Dr. Jadvar and to yourself that you= ve
provided a lot of comments all at once. And I= m not
sure that the subcommittee can, you know, remember all
the comments.
MR. OUHIB: Sure.
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MR. EINBERG: Maybe it= d be better to
address them one by one. And so I= ll leave that to
Dr. Jadvar to decide how to proceed.
MR. OUHIB: Yeah.
CHAIRMAN JADVAR: Sure. Well, I want to
thank Zoubir for all the comments. And I= m sure this
is being transcribed, so hopefully this will be taken
into account by the subcommittee. And again, thank
you.
Now, I see Dr. Michael Folkert= s hand is
up. Dr. Folkert?
DR. FOLKERT: Hi, Mike Folkert, ACMUI
member. I wanted to echo what Mr. Ouhib had said, in
particular about the informed consent.
I definitely think that an informed
consent should be absolutely required, especially for
the high-dose therapeutic procedures. And so, and it
should just be a required part of the procedure. We= ve
been discussing in the medical events committee how
important it is to include a timeout.
And one key part of the timeout is, you
know, making sure that everyone knows what the
procedure is that you= re doing and that they=re
understand why they= re doing it. And I think this is
a critical way to improve patient safety and to reduce
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the risks of a misadministration or other medical
event. So I do think that informed consent should be
required.
The patient education is critical to us
being able to deliver treatment safely. I mean, we,
once patients have been administered a
radiopharmaceutical, they have to understand the
patient safety concerns in order to keep their friends
and family safe when they return home.
So I mean, this is all part and parcel for
the whole part of the procedure. Informed consent
should be required. Patient involvement, patient
education is required and is key to the safe delivery
of radiopharmaceutical therapy.
CHAIRMAN JADVAR: Thank you, Dr. Folkert.
I see that Mr. Richard Green has his hand up too.
VICE CHAIRMAN GREEN: Thank you, Dr.
Jadvar.
Mr. Ouhib, he had lots of good comments.
I want to -- I can=t remember them all, as Chris Einberg
mentioned, there was quite a few. I just want to
address a few that came to mind.
I believe in the context of the charge from
the commissioners, there was a direct quote from the
historical record that Melissa Martin described, the
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various years where the NRC has approached the ACMUI
for comments. And that= s where the direct quote was,
that extravasations are almost impossible to avoid.
And that= s not a current comment or a
current thought, that= s an historical record. And that
should be in there. Same with the, I= m not sure if
it was the commissioners or it was the NRC staff that
said with high level of precision, you know. So
again, that should be a direct quote.
One, I= ll let others embellish upon this.
I think there are many professional societies and
accreditation organizations that require a written --
require an informed consent, signed informed consent.
And I think they will still continue to do so, and
I think that= s appropriate.
I think what the subcommittee was
stressing, not that the NRC be a requirer of written,
of informed consent, but highly recommend that the
licensees conduct patient education with materials to
alert the patients so that they without a great deal
of technical background, should know if something went
awry and be able to inform their caregivers if they
suspect something is amiss.
So informed consent plays a role but we
don= t think as a subcommittee that it was a required
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as part of the NRC regulation. And hopefully others,
I know Dr. Einstein was also very well spoken on this
point.
Thank you.
CHAIRMAN JADVAR: Thank you, Richard. I
see Melissa has her hand up. Melissa?
MS. MARTIN: Yes, I was wondering if Dr.
Folkert would differentiate the requirement for
informed consent versus patient education based on
whether the administration was going to be diagnostic
or therapeutic.
Are you saying that you want -- your
recommendation is to require the informed consent for
all 12 million injections that happen per year? Or
do you -- are you comfortable with requiring it for
the therapeutic administrations?
DR. FOLKERT: Yeah, this is Mike Folkert.
I said specifically for the therapeutic
administrations.
MS. MARTIN: Thank you. I did not hear
that, thank you very much.
CHAIRMAN JADVAR: Okay, moving on, I have
Dr. Richard Harvey.
DR. HARVEY: Thank you, Dr. Jadvar. It= s
Dr. Richard Harvey, the radiation safety officer
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Representative.
So I think the items that Dr. Folkert had
mentioned, those things are already, already being
done. It= s not like they= re not being done. We don= t
need informed consent to do all the things that he
mentioned. They= re all already being done. And doing
informed consent for every injection is just really
superfluous. It= s just not necessary.
It= s not going to improve radiation safety,
it= s not going to improve the quality of what= s being
done. There are already -- there= s already education,
there= s already discharge instructions.
Patients sign off on those discharge
instructions. Patients have consults prior to the
procedure where everything is discussed. There are
alternatives. Everything that they, you know, could
do or don= t have to do or might be able to do.
So the addition of informed consent really
offers no additional benefit. And everything that you
mentioned is already being done. So I think that= s
important to recognize with this. Thank you.
CHAIRMAN JADVAR: Thank you, Dr. Harvey.
Mr. Green, do you still have a question? I see your
hand still up. Is that from before or new?
VICE CHAIRMAN GREEN: My apologies, I
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failed to lower my hand.
CHAIRMAN JADVAR: All right, very good.
So we go to Dr. Einstein.
DR. EINSTEIN: Yeah, I would second what,
the points which Dr. Harvey and Green have mentioned.
This came up and it was the subject of numerous
discussions among the extravasations subcommittee.
Certainly for diagnostic
radiopharmaceutical administration, it would cripple
the system for 15 million patients and maybe 20 million
injections per year in the United States to require
written informed consent.
But the thought of the subcommittee was
even for therapeutic administrations of
radiopharmaceuticals, to add specifically in the
context of extravasations a requirement for formal
written informed consent as distinguished from patient
education, which is really what= s central. We want
to inform patients.
We don= t necessarily want to institute
onerous requirements of more paperwork that are not
going to improve the quality of patient care and patient
outcomes here. And that= s why the subcommittee after
numerous discussions came to this conclusion.
CHAIRMAN JADVAR: Thank you, Dr.
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Einstein. Any other comments by the ACMUI members?
I have one minor comment on slide No. 14.
The sentence regarding surrounding the blood vessel.
I mean, this was really focused initially, as you
mentioned, on intravenous injections in the vein. But
as you know, arteries also are blood vessels.
So I would kind of spell it out,
intravenous, intra-arterial. And then as you added also
intrathecal and any body cavity or space, which I agree
with. Because they= re both vessels.
Any comments from the ACMUI members?
Okay, thank you.
Now with that--
MR. MAILMAN: So I do actually. This is
Josh, I do have my hand up.
CHAIRMAN JADVAR: Yes.
MR. MAILMAN: So there are a couple
things, you know, sorry about that. I= m traveling in
the car and I apologize for some of our connectivity
issues I have here.
But I will want to add a few things here.
So first of all, adding this to informed consent
becomes challenging when we don=t have what we=re
informing the patient on.
If we say that extravasations happen but
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don= t have the frequency to which medical event happens,
we= re, you know, to some of the earlier comments, we= re
adding information but not giving them a likelihood
of what it is that they= re consenting to, right.
They= re -- we need to say it happens in
two percent of the times in this procedure. And I
think, or whatever that number is. And I think that= s
one of the challenges that I have here as a patient,
is that we want to do patient education, which is like
their team, and yet --and maybe informed consent or
adding it to whatever standard checklist that we= re
talking about in addition to what we already go through
with patients.
But we need to be able to give the numbers
that matter to a patient. Just saying here is the risk,
we don= t really know what the risk is is actually
inappropriate. And we need to actually quantify the
risk if we= re going to talk about the risk. We can
talk about how to tell, you know, what it is
informationally so that they can report it.
But if they= re consenting to something,
it= s nearly impossible to consent to an unknown. And
that= s what -- certainly these are -- these are drugs
and things that are not in trials, where we might have
an unknown. These are things that we should have a
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known about.
Can you turn it back to slide 13 by chance?
Yeah, thank you. And slide 13 talks about, you know,
medical societies giving patient education if I --
remembering talks about patient education. And I do
think that we need to make it part of a standard
checklist of what we talk to the patients, whether it= s
the discharge information or however it is, and that= s
part of the guidelines.
But I also think that we need to use
standard language across the medical societies, and
that we should --we really do need to have specific
information again. Giving patient education on an
unknown is really challenging for patients to absorb.
So, and I know there was some comment about
the initial charge that the subcommittee had about
lessening the reliance on patient-reported
information.
I will say it doesn= t preclude the
reporting of patients in that it means to me that we= re
not solely relying on patients and that everyone= s in
the game of all -- everyone should be looking at that
checklist. And everyone is a partner in this and we= re
not just solely relying.
So I don= t mind if the language took the
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onus off the patient. You= re absolutely right, Zoubir,
that patients will notice these things a lot. And (audio
interference) in many conditions, but that doesn= t take
the onus off everyone else in the chain to make sure
that part of the reporting structure and part of the
observation structure.
So I think the charge to the subcommittee
was correct in saying you just can= t fall on the patient
because that= s I think inappropriate. But we have to
give patients good information of which they can help,
work and be a partner in their healthcare.
With that I= ll turn it back and try to lower
my hand on my phone.
CHAIRMAN JADVAR: Thank you, Josh.
So I have two hands up again. Dr. Folkert?
DR. FOLKERT: I apologize, we have power
failures. I= m reconnecting my phone.
You know, my concern particularly for that
consent comment, so I apologize, I= m going back to that,
is that on that page 24, it says A Informed consent should
not be required of the procedures.@
It doesn= t say anything about any -- about
extravasations, it doesn= t say anything like that.
It says A should not be required.@ And that is really
not in keeping with what we= ve been thinking about in
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other discussions for medical events.
I= m not saying that it needs to happen at
the time of the therapeutic procedure, but it is an
important part of it, of the overall treatment plan
for a patient. And for the NRC to make a statement
that informed consent should not be required, I think
that= s overstepping. I think that= s overreach.
CHAIRMAN JADVAR: Good point. Dr.
Richard Harvey. Dr. Harvey, did you have your hand
up?
DR. HARVEY: Apologize, I hit mute and
didn= t come off of mute and I started talking, and I
apologize. So again, it= s Dr. Richard Harvey,
radiation safety officer representative.
So much to comment on there. Let me start
with Dr. Folkert= s because it= s the most recent. I
kind of agree, we don= t want to -- we= re not -- the
intent is not to say that you can= t have informed
consent. Anybody could implement informed consent at
their own organization. I think the intent there is
that it= s not required.
Thinking about some of Mr. Mailman= s
comments, which are important, very important as well,
is this is certainly a team-based approach for the
procedures in nuclear medicine. So when the IVs are
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placed or the injections are done, whoever= s doing it,
the nuclear medicine technologist, a nurse, someone
else, they= re going to be monitoring, they= re going
to be looking for, they= re going to identify
extravasations.
You= re going to talk to your patient. Do
you feel any unusual sensations, do you feel any
burning? They= re going to be looking for swelling.
They= re going to be looking for anything out of the
ordinary.
And you know, you=re going to see this on,
you know, possibly when you= re doing imaging. You
might see some of the dose at the site of extravasation.
There= s definitely a team-based approach to make sure
that, you know, this burden is not all on the patient.
That I don= t think was anyone= s intent. Everyone here
is for the patient, making sure the patient gets the
best possible care that they can.
And you know, anyone in nuclear medicine
wants to put out high quality studies to benefit their
patients. So I think that= s really important to
recognize that, you know, this is a team-based approach
and it always has been.
With regards to extravasations, they do
occur. They= re relatively uncommon. That can be
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argued a bit. But I= ve been doing this for 33 years,
and I= ve never seen an extravasation cause a radiation
injury. And I think it= s very important to segregate
or distinguish between the fact that you can have a
small amount of the radiopharmaceutical extravasating
and it= s going to have no impact on the patient.
I am aware of one extravasation in my
career that happened somewhere else, and yes, I= ve seen
pictures and they do happen. But we don= t want to,
at least in my opinion, make a mountain out of a molehill
when we don= t have very many extravasations causing
radiation injuries.
So I think we really have to recognize
that. And our thoughts are if you identify an
extravasation, you provide the patient with education
and what to do going forward, and you work with them.
If you up front tell everyone that, you
know, there can be an extravasation, it might cause
this, it might cause that, you= re probably
unnecessarily causing fear and anxiety in patients,
you know, for no, really no helpful reason.
You know, if an extravasation occurs, it= s
most likely going to be identified by the team,
including the patient. And then it can be addressed
and it can be dealt with going forward.
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So that= s sort of at least where I= m coming
from on this, and I= m just going to stop there and give
somebody else a change. Thanks.
CHAIRMAN JADVAR: Thank you, Richard.
Let= s see -
MR. MAILMAN: I= d like to --
CHAIRMAN JADVAR: Josh, yeah.
MR. MAILMAN: Re-comment on that really
quick. When we have words like, you know, A very rare@
or you know, A infrequent,@ these are what needs to be
quantified. And I= m, you know, unfortunately I haven= t
been doing this for 30 years, and I= ve been poking my
head around for several and with this topic, for at
least the last year. And unfortunately, I have seen
these things, not to myself.
And I do agree that they happen relatively
rarely. And we can discuss what that is, whether it= s
one in 700, one in 1000, one in whatever that number
is. But we have a set of, you know, we certainly get
a set of comments that say this happens one in every
17 or one in every 30. And the other journal articles
will say it happens one in every, you know, 30,000.
So I think we need to figure out how we
get to a definitive number so that we can give people
the relative risk. I completely agree with you that
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it is, you know, giving the information about what may
happen so you can identify it and saying it happens
very infrequently and here= s what we know is much better
than saying, you know, here it is, we think it doesn= t
happen very much but that doesn= t -- that doesn= t happen
>til we can quantify it.
And I= ll turn off my mic now.
CHAIRMAN JADVAR: Okay, thank you, Josh.
Dr. Harvey again.
DR. HARVEY: Yes, thank you very much, Dr.
Jadvar. Dr. Richard Harvey again, the Radiation
Safety Officer Representative.
I think what, please correct me somebody
if I= m wrong, but I think what the NRC is proposing
is that if we have an extravasation that causes a
radiation injury, it is reported as medical event.
And I think then we get -- and we quantify those numbers,
and those are useful for Mr. Mailman, for patients to
understand.
But to try to quantify every extravasation
that occurs that doesn= t cause radiation injury, at
least in my opinion, it doesn= t have any value. So
you can have --
MR. MAILMAN: Don= t disagree.
DR. HARVEY: A little bit -- that= s fine.
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And we can agree to disagree. And again --
MR. MAILMAN: No, I actually said I don= t
disagree with you at all. I mean, that= s a challenge,
is that if we study this enough or if we actually ran
a trial that we could look at this so that we could
really quantify it, it would be good.
And I= m -- I believe I= m closer to where
you are in the occurrences, but I think we need to get
that data, right. And just -- and that= s what I=m --
that= s not what I= m harping on, but what I believe is
important.
But I don= t disagree in your -- in what
you= re saying at all. We= re not actually disagreeing
at all.
It= s more of I think we have the ability
with the number of phase III trials that are happening
in therapy to really actually quantify these in a
clinical study, in a clinical trial study that can help
inform patients and clinicians in a relatively short
time.
And that that would be a very useful
exercise so that we= re, you know, not waiting for years
and years of collected data but we have something where
we already have things that are ongoing where people
are doing, where people -- where centers are doing,
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you know, three hours post-therapeutic scans. And we
can really quantify and see, one, what= s happening,
and two, at what level do they cause injury so that
we can -- we can really put some numbers behind it.
And that= s all I= m saying, is that I think
we have the means to do better, but I actually think
that ultimately what you= re seeing is that it is a
relatively rare, and we can define what rare is, but
that= s it. We need to define what that is, because
rare to me and rare to you was different until we put
numbers on what that means.
DR. HARVEY: Thank you, Mr. Mailman. I
serious, sincerely respect your comments and your
opinions. I= ll just reiterate I feel that
extravasations that result in radiation injury should
be quantified and that others do not need to be.
And you know, maybe we= ll just differ on
that. And that= s certainly okay. And thank you very
much, and I certainly respect everything that you have
said and you bring to the committee. Thanks.
CHAIRMAN JADVAR: I= ll just add that
talking about data, you see, you may have noticed that,
you know, relatively recently you see some reports in
some cases case reports of extravasations of
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radiopharmaceutical agents. The most recent one I
want to draw your attention to is a case report from
the Netherlands Cancer Institute that was published
in clinical nuclear medicine just this past month.
And in that, this patient was undergoing
a peptide receptor radionuclide therapy, PRRT, with
a lutetium-177 dotatate, and a third of dose was
extravasated in that case. They had an image of that
in the case report, and they did the usual thing with
the lifting the arm above the level of the heart and
warm pads and the usual interventions.
And in this particular case, actually
after treating the patient at 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, there was really
very little left at the site of extravasation, of
injection of the agent. And the agent slowly cleared
to the target -- to the targets, the somatostatic and
receptor expression tumors.
And they followed this patient for 11
months, and there was no radiation injury whatsoever.
Although as I said, a third of the dose of therapeutic
dose was extravasated.
So things of this sort are being published,
and it would be good to keep track of these publications
as they come out.
I see Melissa has her hand up. Melissa?
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MS. MARTIN: Actually what I want to do
is have Dr. Einstein speak, because he was very active
in this subcommittee and has lots of information as
a practicing nuclear medicine physician. I think his
input would be very valuable.
CHAIRMAN JADVAR: Dr. Einstein, you= re
muted. Please unmute yourself.
MS. MARTIN: Take yourself off of mute,
Dr. Einstein. No.
CHAIRMAN JADVAR: We still cannot hear
you.
DR. EINSTEIN: Can you hear me now?
MS. MARTIN: Yes.
DR. EINSTEIN: Okay, fantastic. Yeah,
you know, so I mean, I= m a practicing nuclear
cardiologist, not a general nuclear medicine
physician, so the doses of the radiopharmaceuticals
which I administer to patients are lower and the
consequences of an extravasations lower as well.
But you know, I= ve researched this subject
and spoken to nuclear medicine and interventional
radiology colleagues as part of being on this committee
just to understand things better.
And you know, my impression, having served
on this committee, you know, based on what my colleagues
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think, it is really to share the opinion, again, that
patient education, shared decision-making is
important. But formal written informed consent goes
beyond what would be required, given the statistically
very rare occurrence. So I share the perspective taken
by the subcommittee.
CHAIRMAN JADVAR: Thank you, Dr.
Einstein. Any other comments by the ACMUI members?
We had a very robust discussion, that= s wonderful.
Thank you.
Any other comments?
MR. OUHIB: Yes, this is Zoubir Ouhib.
CHAIRMAN JADVAR: Okay, just go ahead.
MR. OUHIB: I= d just like to go back to
the consent form item. First of all, I don= t think
NRC should be involved or make any statement saying
that the informed consent form is not needed. That= s
not the role of NRC. That= s medical practice, in my
opinion.
And then there seemed to confusion between
an informed consent form and patient education, patient
instruction, and so on and so forth. The informed
consent form is a legal document, especially for
therapeutic dose, basically. And that= s a
requirement.
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As far as patient instruction and patient
education, that= s -- that= s part of the chart patient
that it was provided that do this, don= t do this, do
this, do this, call us and so on and so forth.
So I want to clarify that. Thank you.
CHAIRMAN JADVAR: Thank you, Zoubir. Any
other comments by the ACMUI members? All right --
MS. ALLEN: Hi, it= s --
CHAIRMAN JADVAR: Okay, yeah, Ms. Allen,
please.
MS. ALLEN: Yes, it= s Rebecca Allen,
healthcare administrator. You know, we talk about the
informed consent and the NRC= s role. However, just
keep in mind is that the -- most informed consents in
the hospital are dictated more from a joint commission
regulatory guidelines, not about the radiation piece.
So regardless of NRC, if anyone recommends
informed consent or not, this is by hospital about the
requirements of who will need an informed consent or
who does not. Thank you.
CHAIRMAN JADVAR: Thank you, Ms. Allen.
I can just tell you that we do use informed consents
for all the therapeutics injections.
Any other comments by the ACMUI members?
MR. DIMARCO: Hi, Dr. Jadvar?
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CHAIRMAN JADVAR: Yes.
MR. DIMARCO: Hi, this is Daniel DiMarco
from the NRC. I just wanted to come in and make a quick
clarification about this entire discussion that we= ve
been having.
In the proposed model procedures bit of
the package that you all reviewed, there= s a bit in
there about patient information. And we= ve heard Dr.
Harvey and Richard as well talk about the patient
intervention part on that.
I want to be very clear about this. I very
specifically did not say anything about a formal
informed consent procedure. I agree with the other
members of the ACMUI, but that it= s not something that
the NRC is -- that= s not in the NRC= s jurisdiction,
it= s likely not. It= s likely very much a part of
medical practice.
The intention with that was never to be
in a -- whether a recommendation on informed consent,
merely just a recommendation that patient education
could help in being part of the team response to a
potential extravasation. Yes, so that was -- that was
all the intention there. It was never to be a specific
informed consent bit there.
I very specifically did not use the term
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Ainformed consent@ for that reason. So yes, just to
-- just to clarify for everyone that that was the
intention there.
CHAIRMAN JADVAR: Thank you very much, Mr.
DiMarco.
Now that you are -- any other comments by
the NRC staff? Oh, I see Dr. Andrew Einstein again.
Please, go ahead.
DR. EINSTEIN: Yeah, thank you. Daniel,
I think the concern which the subcommittee had is that
there was some verbiage originally proposed which used
the word A informed@ in there, and it= s difficult to
-- for readers to tease out about informed versus
informed consent.
So once the original verbiage was going
down that road, maybe not completely but leaning in
that direction, it was felt that there was a need to
opine and weigh in there.
CHAIRMAN JADVAR: Okay. Any other
comments by the NRC staff?
DR. TAPP: Yes. This is Katy Tapp with
the NRC staff. One of the things is I asked Sarah to
pull up the comment from the subcommittee= s report.
Because you guys had a lot of good discussion on this.
And I just want to make sure that these is just a
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discussion right now, and that we= re not recommending
changes here to either of these recommendations.
I didn= t hear anything, but I want to make
sure I= m capturing your thoughts correctly. So I asked
her to pull up the comment specifically on informed
consent and making sure we= re -- there wasn= t any
changes that we= re missing here.
CHAIRMAN JADVAR: Melissa?
MS. MARTIN: I would agree with that.
That= s why we labeled them A specific comments.@ But
this is not -- these were not specific motions to make
changes at this time. They were items we thought
should be considered.
CHAIRMAN JADVAR: Dr. Folkert.
DR. FOLKERT: Okay, it= s me, Folkert.
Yeah, I mean, this is, this particular comment, though,
this is the concern. As a policymaking body, the
statement is being made that informed consent should
not be required for either diagnostic or therapeutic.
And that -- I mean, to say that informed consent should
not be required, I do not think that that= s an
appropriate statement to be made.
CHAIRMAN JADVAR: Okay. Any other
comments? I have Mr. Green.
VICE CHAIRMAN GREEN: Yes, this is Richard
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Green, the nuclear pharmacist representative. Dr.
Folkert, I think we could take that item 17, page 1,
and take that further where informed consent should
not be required by the U.S. NRC or licensing agency.
So it= s this agency is not requiring it as part of
this regulation.
If other agencies, other CMS and
accreditation organizations, that= s their prerogative.
And that more likely is the case, that= s a fact of
life today. We just wanted to make sure that folks
who read this guidance document didn= t see, you know,
inform your patient is basically what it said. I go,
well, that= s confusing. That= s --it= s ambiguous.
So yes, patients should be informed, they
should be educated, they should be on the lookout.
But we= re not saying they have to have written informed
consent. So I think if we modify that to informed
consent should not be required by regulators of the
U.S. NRC, we can modify that. But that= s what we were
striving toward.
Thank you.
DR. FOLKERT: And that makes more -- that
makes sense. And so it= s just this statement is just
far too global.
CHAIRMAN JADVAR: Okay, thank you. Dr.
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Wolkov, I think you had your hand up. Are you planning
to speak?
DR. WOLKOV: I did have my hand up, but
I think that was reasonable compromise language by Mr.
Green. And I had an alternative language, but I
actually prefer his to mine.
CHAIRMAN JADVAR: Okay. Dr. Harvey?
DR. HARVEY: I would second Mr. Green= s
motion. And I think we should vote on that. NRC staff
can correct me if that= s wrong, but I think I would
second his motion. Thank you.
CHAIRMAN JADVAR: Very good. Let me see,
I think we were going to wait a vote on the
subcommittee= s report at the end of the public comments,
if that= s okay.
But any other comments by the NRC staff
before we move on?
MR. OUHIB: Yeah, this is Zoubir Ouhib.
CHAIRMAN JADVAR: Okay.
MR. OUHIB: I= m just curious whether there
is a need to have that first sentence at all. Why do
-- why shouldn= t -- what is the purpose of having that
sentence AInformed consent should not be required for
either diagnostic or therapeutic nuclear medicine
procedure.@ What is the purpose of that?
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Why don= t we just strike and just simply
put patient education, whether done verbally, et
cetera, et cetera, et cetera?
CHAIRMAN JADVAR: Okay, Dr. Harvey.
DR. HARVEY: The only intent of that
section -- that sentence, was to clarify. Because when
some people read the document, they thought that it
might be asking for written informed consent. So the
point of that sentence was to clarify that the NRC and
Agreement States, regulatory bodies are not asking for
informed consent.
CHAIRMAN JADVAR: Very good. Okay, any
other comments from NRC staff or other --
MR. MAILMAN: Would that be a separate
informed consent? Because I think to, Dr. Jadvar, your
comment as well, you require an informed consent at
USC, which is fine. It= s just, we=re not recommending
a separate informed consent on board the subcommittee,
which I think would be more appropriate than just
throwing it out there.
CHAIRMAN JADVAR: Well, let= s ask folks
on this call that do you require informed consent for
therapeutic injections at least?
DR. FOLKERT: Definitely. Mike Folkert,
definitely. Required by JAYCO, required in --
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CHAIRMAN JADVAR: Yeah.
DR. FOLKERT: By our professional
societies across the board.
MR. OUHIB: Absolutely, it= s a must.
CHAIRMAN JADVAR: Yeah, yeah.
MS. MARTIN: But I think to clarify, it
wasn= t a separate consent. I think that= s the
question. It= s the one that you= re required to have
for joint commission and all the other accrediting
bodies.
CHAIRMAN JADVAR: Yeah.
MR. OUHIB: But also required by, you
know, ASTRO, by ACR, by there= s a whole document --
MS. MARTIN: Right, which are accrediting
bodies, right.
MR. OUHIB: There= s a whole document
written by ACR ASTRO regarding that.
DR. FOLKERT: Yeah. Now, I= m not saying
anything about a separate consent. I= m very concerned
that there= s a statement here saying A informed consent
should not be required.@ It doesn= t say anything about
an additional consent, it doesn= t say anything about
a form.
It is a policymaking body, the NRC is
stating that informed consent should not be required.
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And I don= t think we should be saying that.
MS. MARTIN: Yeah. I like the
modification that was made to the statement earlier,
required by the NRC. With the idea that I think we
could develop that statement further. It= s developed,
the informed consent should be developed in accordance
with the professional societies.
CHAIRMAN JADVAR: Okay. All right, I
think I= m going to turn this over to Ms. Sarah Lopas
to navigate us through the hearing public comments on
this subcommittee= s report.
Sarah?
MS. LOPAS: First I wanted to just double
check that we didn= t need to go through any of Zoubir= s
earlier comments when he first started and he had kind
of a list of comments. I just wanted to double check
that we didn= t need to go back through the report, now
that I= m sharing the report.
MS. MARTIN: I think we= ve covered most
of them.
MS. LOPAS: Okay. All right, well, with
that, I am going to --we are going to open it up to
the public to make comments. So I want to make a couple
notes before we get started.
So those of you that have submitted
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comments ahead of time, written comments, those will
be upended directly to this transcript. So those= ll
be publicly available, attached directly to this
transcript. So that= s one note.
I also want to note that we= re looking for
your comments today on what the ACMUI just discussed,
on their recommendation report, which is available on
the ACMUI website. If you have general comments on
the extravasation proposed rulemaking, you know,
generally, at some point in the future this rule may
get published as a proposed rule and there will be a
public comment period.
You know, there= s several steps to get to
that point. We have to finalize this document, we have
to submit it to the Commission for their consideration
and review. If they were to approve it for
publication, there= s a couple more administrative
processes.
And then it would finally get published
and we would have -- we= d give everybody ample notice
of when that proposed rule comment period is coming,
and we would have probably several public meetings to
help clarify the package for everybody.
So I just wanted to just let everybody know
this isn= t -- this isn= t a one-and -done deal, right.
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This is one step of many in a public meeting process.
So with that, we= re going to use the
raise-hand function for those of you that are in the
Teams app. For those of you on your cellphones, I
believe you press star-5 to raise your hand. So that
will let me know.
So we can kind of get right into it. And
we do have to leave about 15 minutes at the end to allow
the ACMUI to just finalize their thoughts based on what
they= ve heard from the public and take their vote.
So we will be kind of folding up comments at 3:45, just
to give everybody a warning.
Okay, and I see David, I know you= ve had
your hand raised for a long time, so go ahead, you can
go ahead and unmute yourself. And please begin by
introducing yourself and stating your affiliation if
you have one. That= s helpful for the transcript as
well and to give us all some context.
So thank you, go ahead, David Bushnell.
DR. BUSHNELL: Sure, thank you very much.
David Bushnell, the National Program Director Nuclear
Medicine in the Veteran= s Health Administration.
A very interesting discussion, a very
interesting process that= s been going on here for a
while. I thought I saw, and maybe I misread it, I
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thought I saw in one of the slides that NRC was
potentially going to propose mitigation procedures.
And maybe I= m misunderstanding, but
perhaps you could clarify whether they mean medical
mitigation procedures. If that= s the case, that would
-- that would certainly not, I think we= d all agree,
that would certainly not be appropriate.
MS. LOPAS: Dr. Harvey, do you have your
hand raised?
DR. HARVEY: I do, thank you.
MS. LOPAS: Yeah.
DR. HARVEY: I think, so what I would
recommend and what we talked about is individual
licensees should have their own policy and procedures
for identification, management, mitigation, patient
education.
Those things should all be handled with
-- at the -- by the licensee. And I don= t think there= s
any push from the subcommittee anyway to say that there
should be specific procedures written by the NRC that
licensees would have to follow.
Thank you.
DR. BUSHNELL: Thanks very much. Perhaps
I misunderstood, and thank you for clarifying that.
And I thought the -- by the way, the discussion on
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the informed consent was very good.
Obviously we all agree that there has to
be informed -- from a medical standpoint. And
certainly even though rare, we would include the
potential radiation complications from extravasation
for therapeutic procedures within the informed
consent.
I mean, there= s a lot of risks, right,
there= s a lot of risks that we deal with for
radiopharmaceutical or radio-likened therapies. And
this would be one, although rare that we would include
as well. Thank you.
MS. LOPAS: All right thank you. Okay,
and I see Dr. Wallner. Dr. Wallner, you can go -- oh,
unless is somebody else going to jump in? I thought
I heard somebody. No?
Okay, Dr. Wallner, go ahead. You can
introduce yourself and state your affiliation.
DR. WALLNER: Thank you very much. Dr.
Paul Wallner representing the American College of
Radiology. I= m a radiation oncologist.
We think there should be some
clarification of some of the language regarding medical
radiation injury. We think that the language should
be clarified that it should be radiation injury
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requiring medical intervention.
I don= t think we are interested in any
potential radiation injury, just something that
requires intervention. And I think that was the intent
of the commissioners.
Secondly, again, regarding radiation
injury, there is very speculative verbiage suggesting
that it can be attributed to radiation. We would
suggest that that be changed to A has been attributed
to radiation@ or Ais most likely attributable to
radiation.@ A Can be attributed to radiation@ is
highly speculative and could be judged by many people
incorrectly.
The other issue regarding medical events
reporting, we would recommend deleting, and this is
in quotes A or has the potential to result in radiation
injury.@ Again, that= s highly speculative.
There was some comment, and I will provide
these comments in writing to Ms. Armstead so they can
be added to the record. There was also some comment
about clinical trials and the reporting of adverse
events.
Any clinical trial in the United States
certainly that is approved by an IRB, and that=s
effectively all clinical trials, requires adverse
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event reporting, regardless of the intervention or
regardless of the adverse event. So that= s readily
available in those reports, and I wouldn= t suggest any
additional reporting mechanism in that regard.
Thank you very much.
MS. LOPAS: Okay, thank you, Dr. Wallner.
Okay, so a reminder that raise your hand,
that= s the little raise-hand icon. You can just tap
that once on Teams. If you= re on the phone, you press
star-5. And we will give everybody a couple of minutes
before we send it back to the ACMUI.
And just as a reminder, we= re taking the
public comments on the subcommittee= s recommendations
here today as they presented them today and in their
report. And you can find that, their report and what
they reviewed for us on the ACMUI website.
I just pulled it up, right in time for this
meeting. I pulled up, I Googled A ACMUI@ and
Arecommendations and extravasations,@ and it came
right up for me. So, very easy to find online if you
do need to review that.
I think, Dr. Jadvar, seeing as I=m not
seeing other, any other hands raised, I think I= m going
to send it back to you all. And I don= t know if Chris
jumps in as well to help kind of close you out and maybe
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Dr. Tapp as well, so.
CHAIRMAN JADVAR: Okay, thank you, Sarah,
for your help.
So let= s go back to, we need to vote on
the subcommittee= s report. But before we do that, I
want to make sure that if there is any alterations or
other additions or changes that you want to make to
the report based on all the discussions that the
subcommittee heard.
MS. MARTIN: Hello, this is Melissa. I
do think we need to take the comments that Richard
Harvey made. I just remember Richard making them, I= m
not sure who made them initially, but there was a couple
of things that we agreed on to make it as --
modifications to this report.
CHAIRMAN JADVAR: Okay. Would you please
repeat those items one more time for clarity?
VICE CHAIRMAN GREEN: This is Richard
Green. I believe it was Item 17. We want to specify
it= s the informed consent is not required by the U.S.
NRC.
MS. MARTIN: Correct.
VICE CHAIRMAN GREEN: I do know that= s a
very open statement that it= s not required. So that
should be modified. So I= m suggesting that informed
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consent should not be required by the U.S. NRC for
either diagnostic or therapeutic nuclear medicine
procedures. Just a small inclusion.
CHAIRMAN JADVAR: Anything else?
DR. HARVEY: I would second that.
Richard Harvey.
CHAIRMAN JADVAR: Okay, thank you. Any
other items? All right, so with that, do I have a
motion for approval of the subcommittee= s report with
that stipulation that was recited?
DR. WOLKOV: So moved, Harvey Wolkov.
CHAIRMAN JADVAR: Any seconds?
DR. HARVEY: Second.
DR. FOLKERT: Second.
CHAIRMAN JADVAR: All in favor, say aye.
(Chorus of aye.)
CHAIRMAN JADVAR: Any opposed? None,
none heard. Any abstentions?
DR. EINSTEIN: Aye.
MS. ALLEN: Aye. This is Rebecca Allen.
MR. MAILMAN: I don= t know if you can hear
me or not.
MR. OUHIB: This is Zoubir Ouhib.
CHAIRMAN JADVAR: Okay, I was talking
about any abstentions.
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MR. MAILMAN: Well, I don= t know if --
DR. FOLKERT: Is the audio not going
through? Sorry.
MS. MARTIN: No, we can hear you, Dr.
Folkert, go ahead.
DR. FOLKERT: Yeah. No, so I mean, you
had asked if there were other --if there were other
questions about the report?
CHAIRMAN JADVAR: Oh, yes, okay.
DR. FOLKERT: So that, you know, so I mean,
so we mentioned this one. I mean, the other thing which
I do think Dr. Wallner= s point actually was quite good
about removing A or has the potential.@ And so yeah.
So that was --
MS. MARTIN: What line was that, do you
know which line?
DR. FOLKERT: Yeah, so let= s see. If we
go, let= s see, it=s in the -- so in the reporting nuclear
medicine --
CHAIRMAN JADVAR: Page 10.
DR. FOLKERT: Page 10 and 11.
CHAIRMAN JADVAR: Yup.
DR. FOLKERT: And so like let= s see, so
on page 10, second paragraph from the bottom, A or has
the potential to result in radiation injury.@
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MS. MARTIN: Yes.
DR. FOLKERT: And then also page 11, where
it also says A or has the potential to--@ Where was
the? I was trying to do a search for that specific
phrase, but there are, I know that there was more than
location where it was said.
MR. OUHIB: You are correct, it was on 11
also.
DR. FOLKERT: Yeah. And then also, I
mean, in the index also on point F, why does the report
of threshold require reporting for extravasation of
results or has the potential to result in a radiation
injury from an extravasation.
So, I mean, I agree that removing Aor has
the potential@ because I mean that= s incredibly vague
and speculative. So removing that A or has the
potential for causing injury@ I think would make sense
to remove.
MS. MARTIN: I agree.
MR. OUHIB: Yes.
DR. FOLKERT: I have those items on my
list.
CHAIRMAN JADVAR: Okay, so we have to vote
again. Any other items?
So I heard three stipulations or changes,
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alterations. Is that correct?
MS. MARTIN: Correct.
CHAIRMAN JADVAR: All right, so with that
DR. TAPP: This is Dr. Tapp with the NRC.
Can I?
CHAIRMAN JADVAR: Sure.
DR. TAPP: Just make sure that I= m
following here. This is actually not on the report
itself, but this is actually an additional
recommendation to the proposed rulemaking, am
capturing this correctly. So this is actually on the
rulemaking text.
And we= re talking about an extravasation
that results or has the potential result in radiation
injury. So I just wanted to capture that that was to
the text.
And just to give a little bit of history
on staff= s, so everyone= s aware here that the thought
on this text language was for when there is an
extravasation that is maybe on a therapeutic, that is
a large dose. And that you have a physician who
believes and determines that it has a potential to
result in radiation injury. So, a large does that has
that potential.
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And you know up front you want to do this
quick reporting so we can have maybe something that
is something that could reoccur in other locations,
getting this quick reporting to the NRC, that was the
purpose of adding this A or has the potential.@
So, just want to make sure that background
was given to the ACMUI for this.
MR. EINBERG: And this is Chris Einberg.
Yeah, sorry to interject. This is a huge shift in
fundamentally what our approach would be if we removed
this language. And so if you make that recommendation,
please make it fully informed that you know, this is
a big shift in our approach.
CHAIRMAN JADVAR: Okay, thank you for that
explanation.
Dr. Harvey?
DR. HARVEY: Rather than say A has the
potential,@ can we say A expects@ ? I think the idea
here is if the authorized user or the physician expects
it to resolve in a radiation injury, that we report
it, and take out the vagueness of A has the potential.@
It= s just a thought.
PARTICIPANT: Results could be expected
to result -- yeah, I like that phrasing, A that results
or could be expected@ or Awould be expected to result.@
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MS. MARTIN: Could be expected results or
would be expected to result.
CHAIRMAN JADVAR: Is then A would be
expected,@ isn= t that a little firmer than A has the
potential@ ?
MS. MARTIN: Yes. It= s harder.
CHAIRMAN JADVAR: It= s harder. Is that
-- is that what you want? You know, in other words
you already have surmised that this is expected, it=s
going to happen. But A has the potential@ is still is,
I think is less firm. You know, you think it may
happen, it may not happen.
DR. FOLKERT: Yeah, because when you= re
looking at doses --
CHAIRMAN JADVAR: So I think the A has the
potential@ is -- I think A has the potential@ is, I= m
okay with that, but you know, I leave it up to you.
DR. EINSTEIN: How about A is likely to@
as an intermediate language? AHas the potential to@
could have a very tiny probability of it occurring.
DR. FOLKERT: I like that better.
DR. EINSTEIN: A Is expected to@ has an
extremely high probability.
DR. FOLKERT: Yup.
CHAIRMAN JADVAR: Okay, well.
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DR. FOLKERT: ALikely@ seems like a
reasonable compromise.
PARTICIPANT: That= s reasonable.
CHAIRMAN JADVAR: so Chris, going back to
what you mentioned, Mr. Einberg. If this A has the
potential@ wording is changed to something else, is
that a --is that an issue, major issue? What --is
that okay?
MS. MARTIN: If it= s changed to A is likely
to,@ I think that= s been the suggested changing --
changed wording.
MR. EINBERG: So I will ask members of the
medical team to opine, either Dr. Tapp or Daniel
DiMarco, to weigh in on this. Because I know that they
extensive discussions in the working group when they
were developing this language, and I think Daniel is
ready to discuss that.
MR. DIMARCO: Hi, Chris, hi, members of
the ACMUI. Daniel DiMarco here for the NRC. The major
change here with the addition or I guess the deletion
of this wording, like Dr. Tapp said before, was that
this specifically went to the timing of the
extravasation, where we know that radiation effects
typically have some sort of lag time or delay time.
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And so the wording of this, like Dr. Tapp
said before, as well as the wording that, from what
I= m hearing, you guys are thinking about changing it
to with A expected@ or A is likely to,@ it was -- the
wording was in there specifically to capture these
events before any symptoms appear.
Where there= s, you know, some amount of
potential based on, well, where we have it as determined
by a physician determination, there= s some sort of
potential for radiation injury, and therefore it could
be reported before any symptoms appear so we can get
the information quickly and help the patient as soon
as we can.
So, from what I was hearing with some of
the potential changes you were having with the wording
here, if you= re changing it from A has the potential
to@ to maybe something like A is expected to@ or Ais
likely to,@ then that wouldn= t be a major change in
the reporting requirements that we= ve set out.
But if you did away with the language
altogether, that would be a major change to the
reporting requirements as we> ve set them out. I hope
that clarifies things.
CHAIRMAN JADVAR: Yeah, very much. Thank
you.
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MR. OUHIB: This is Zoubir, if I may.
CHAIRMAN JADVAR: Please.
MR. OUHIB: This is for DiMarco. What do
you think if we say, you know, like, and notification
of a medical event that result or based on certain
indications, clinical indication, or whatever that is,
has the potential to result in a radiation injury?
We just add something that= s convincing
that the potential is not vague, there= s some -- there= s
something behind the justification for that matter.
MS. MARTIN: Well, I think that= s what kind
of we covered -- oh, go ahead -- by the Ais likely to.@
MR. DIMARCO: Oh, no, I think you were,
well, that= s, for the NRC, when I put that in there
or when we put that in there, the A as determined by
a physician@ bit at the very end of that, that was the
key factor there, where the NRC is not interested in
getting into these determinations of whether or not
something like this has the potential for radiation
injury.
We recognize that the physicians as well
as their teams have the -- have the required experience
and expertise as well as the tools necessary to make
that determination themselves. And so we didn= t want
to step into the clinic, as it were, to make these
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determinations themselves.
And so we were putting the determination
in the hands of those who have the best experience and
the best tools to make that determination themselves,
the physicians and their teams.
MR. OUHIB: Thank you.
CHAIRMAN JADVAR: Thank you. Yeah, I
just give my opinion. I don= t see any specific problem
with this as it is. It says at the end is determined
by a physician. Yes, there may be a potential based
on judgment, clinical judgment, that it could be
something like that. And you follow it, if that= s what
the physician decides.
I= m not sure, when you put A likelihood@
or Aexpected,@ you know, you= re adding one level of
certainty to it, and I don= t know if that= s necessary.
A Potential@ is open, you know, it could be may happen,
may not happen. Anyway.
DR. FOLKERT: Well, I think the concern
would be if just say A potential,@ that could be 1%,
2%, 3%, whereas if you say A likely,@ then that= s at
least probably more that 50% chance that there= s a
possibility.
CHAIRMAN JADVAR: Anywhere from say
20-80% would be the intermediate DQs (phonetic)-- yes.
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DR. FOLKERT: But I mean, we= re talking
about therapeutics. I mean, even like half of a cc
could have the potential of causing some issues. So
it= s like, yeah, just saying A potential@ is, I agree,
it just seems to be too vague, with the public comment.
So I would say at least go with A likely@
or A expected.@
CHAIRMAN JADVAR: Okay. Okay, so is
everybody agreeing? And I think Dr. Einstein
suggested A likely.@ Is that acceptable?
MS. MARTIN: I agree. I think, well this
is Melissa. I think the A is likely to@ is the best
one.
CHAIRMAN JADVAR: Okay, A as determined by
a physician,@ which is at the end of the sentence.
MS. MARTIN: Mm-hmm.
CHAIRMAN JADVAR: Okay. And I think that
would be a-- that would not be a major change as
described by Mr. DiMarco, right?
MS. MARTIN: Correct.
MR. EINBERG: Yeah, we agree. I see Dr.
Tapp came on. If she could have a moment.
DR. TAPP: Yeah, and I know you guys, if
I may, you do like specific language to provide in your
recommendation. However, terms like A potential,@
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Alikely,@ and Aexpected@ all do have a slightly
different meaning when we go into regulations. And
sometimes are, there are rulemaking trigger words that
we don= t like to add.
So if you prefer and you= re still debating
between Alikely@ or Aexpected,@ you could add both
to your report if they= re both okay to you, if you like
them better than A potential.@ And then we can work
through that back here with our administrative staff.
Because I= m not sure, A likely@ sometimes does have
some concerns with our regulatory administrative staff
that does look at this.
So if both are okay, maybe add, you could
add A likely or expected@ to your recommendation.
CHAIRMAN JADVAR: Yeah.
MS. MARTIN: That= s okay then.
CHAIRMAN JADVAR: Is that okay?
MS. MARTIN: That gives you guys a little
bit of leeway.
CHAIRMAN JADVAR: Okay.
DR. TAPP: Thank you.
CHAIRMAN JADVAR: Okay, thank you, Kate.
All right, sounds good.
So any other things before we vote again?
MR. UNDERWOOD: So I did have one
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question. And this may be obvious to me but I may have
missed something. But Aas determined by a physician@
is a very wide statement. Is it -- I mean, is that
meant to be A authorized user@ ? Or, so any physician
with any medical degree can determine if the radiation
injury is likely to occur and it= s a reportable event?
MS. LOPAS: And just to clarify, this is
Kyle Underwood. This is somebody, this is external.
I= m just clarifying for the transcript, Kyle
Underwood.
MR. UNDERWOOD: Sorry, thank you, I should
have said that.
MS. LOPAS: No worries.
MS. MARTIN: In the past, we= ve gotten lots
of comments from the public that it= s too restrictive
to restrict it to authorized users. So that= s why it
was left purposely at this point just by a physician.
CHAIRMAN JADVAR: Right. And I remember
that what Daniel showed at the end of this reports,
it says that the patient, when the patient received
the dose and all that. So any physicians in medical
degree should be able to determine that this may have
been caused by radiation.
Anyway, so are we good, or additional
comments before we do the vote?
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So, let= s have a motion again for this
subcommittee report, with the stipulations that were
recorded.
Do we have a vote --do I have a motion?
Anyone?
DR. EINSTEIN: So moved.
CHAIRMAN JADVAR: Okay, any seconds?
DR. FOLKERT: Second.
MR. EINBERG: Can you please -- can you
please identify who made the motion and who seconded
for the court reporter, please?
CHAIRMAN JADVAR: Oh yes.
DR. EINSTEIN: Andrew Einstein, so moved.
DR. WOLKOV: Harvey Wolkov, second.
CHAIRMAN JADVAR: Harvey Wolkov, second.
All in favor, say aye.
(Chorus of aye.)
CHAIRMAN JADVAR: Any opposed?
MR. OUHIB: Aye.
CHAIRMAN JADVAR: Any opposed? Any
abstention?
MS. ALLEN: Aye, Rebecca Allen.
CHAIRMAN JADVAR: Okay, thank you. So
the subcommittee report is passed with the stipulations
as recorded.
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And I think that= s the end of our business
today. So I want to turn it back to Mr. Einberg.
MR. EINBERG: Okay, yeah, thank you, Dr.
Jadvar. Thank you, subcommittee members who worked
diligently with NRC staff for the support on this.
Thank you for the ACMUI members as well. Thank you
to the insightful comments that we received from the
members of the public. This all helps us inform our
rulemaking process.
As Sarah Lopas pointed out, as we move
forward in finalizing our rulemaking and guidance
development, we will be providing this to the NRC
commission. After such, if they agree to publish this,
then there will be other opportunities for members of
the public to comment on this.
So this is a, you know, a process where,
you know, we value public input. And the members of
the public will have additional opportunities to
comment. As Sarah also pointed out, the comments that
we have received will be appended to the transcript.
And so that will be made part of the record as well.
And so with that, I thank you all on behalf
of the NRC, and we can adjourn the meeting.
CHAIRMAN JADVAR: Meeting is adjourned.
Thank you, everyone.
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(Whereupon, the above-entitled matter
went off the record at 3:40 p.m.)
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234 -4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com To Whom It May Concern:
Thank you for considering this public statement regarding the June 17 th meeting to discuss the ACMUIs subcommittee report on the NRC staffs proposed changes to NRCs requirements for medical use of byproduct material to address reporting of nuclear medicine injection extravasations as medical events.
I am Daniel G. Guerra Jr., founder and CEO of Altus, a technology services company that focuses on radiation technologists who work in clinics and hospitals to keep patients safe during medical imaging such as CT scans and radiation therapy. Altus offers a range of products including continuing education courses for radiation technologists, tools for clinics to organize their credentialing requirements, and webinars for scientific device manufacturers.
I have followed with great interest the actions of NRC, ACMUI, and Congress regarding medical event reporting of nuclear medicine extravasations. A couple of years ago, Altus hosted a panel discussion focusing on how radiopharmaceutical extravasation affe cts the quality and quantification of nuclear medicine imaging studies, and a series of interviews with subject matter experts on the topic.
From lobbying disclosure records and a recent critical report by NRCs Office of the Inspector General, I have become aware that professional societies that represent nuclear medicine physicians, whose members populate ACMUI, are engaged in lobbying against medical event reporting of large extravasations. This policy position is counter to the views of prominent individual physicians and subject matter experts, and counter to the view of a large coalition made up of dozens of patient advocacy organizations.
I think all parties involved would agree this is an important issue for patient safety and transparency. I also believe it is critical that policymakers and regulators benefit from honest, unbiased, and unconflicted advice as they decide this policy issue . NRC, Congress, and the public must hear an open exchange of views on this matter, in which statements not borne out by scientific and clinical evidence can be challenged and debunked. Policy must be based on the best scientific evidence for the benefi t of patients, not predetermined by well-placed insiders.
That is why I offer the services of Altus to host an online forum featuring proponents and opponents of medical event reporting of large extravasations can make their arguments and challenge statements that they believe to be false. I believe this would be illuminating and helpful for policymakers, regulators, and the public. I hope NRC and ACMUI consider this good -faith proposal and accept it in the spirit of supporting the best science for the benefit of patients.
I look forward to hearing from NRC and ACMUI about this possibility.
Daniel G. Guerra Jr., CEO
Altus l PO Box 910 l Madison, WI 53701 Direct: 608- 212-2391 l Email: dguerrajr@altusinc.co Website: https://altusinc.co l https://thenhti.org
I am writing to express my concerns regarding the NRC rulemaking process and the proposed rule.
The public is being asked to provide comments and questions regarding the recently announced ACMUI subcommittee report on NRCs proposed rulemaking for the reporting of extravasations. I have no insight into the what the report says and was given an extremely short turnaround time to submit a comment. Additionally, the published Special Investigation report from the OIG would lead me to believe that the two individuals accused of violating federal ethics rule should recuse themselves from discussing this issue with NRC medical staff.
As such, I believe the proposed rule re"ects the improper in"uence of con"icted members of the ACMUI. The recommendation to use qualitative reporting criteria for patient injuries related to extravasation of radiopharmaceuticals is alarming. It disregards the longstanding reasons for dismissing such criteria, which were clearly outlined in the 1980 Federal Register.
The proposed rule by the NRC exacerbates the problem for patients. Most patients are unaware they are being injected with radiation during nuclear medicine scans. Many patients believe they are being injected with some kind of contrast or dye. Additionally, it is a well-known fact that patients are not given information about the symptoms of ionizing radiation damage. Without monitoring for extravasations and without crucial information of symptoms that may arise weeks, months, or even years later, patients will not know they are experiencing effects from an extravasation.
Additionally, I have come to understand that nuclear medicine physicians typically do not take patient appointments. Even if they did, the question arises: who would bear the cost of these extra office visits? This is another added burden that patients should not have to shoulder.
My concerns extend to the broader issue of healthcare inequities and systemic racism in healthcare facilities. Qualitative patient-reported injury criteria disproportionately impact minorities. Since your committee lacks diversity, ACMUI may not fully gras p how unlikely it is for patients of color to report, much less convince a physician, that an injury is related to radiation exposure when there is no documentation of extravasation and potentially no visible skin damage. This creates a signi"cant barrier for patients of color, further deepening the disparities in healthcare.
My stake in this issue is deeply personal. I started the New Day Foundation for Families in 2007 with my husband Michael. We both lost our "rst spouses to cancer, giving us an intimate understanding of the emotional and "nancial toll cancer takes. Both my sons receive yearly nuclear medicine scans due to their high risk of developing cancer. Without the monitoring of extravasations, I am not con"dent that the scans are 100 percent accurate.
Unfortunately, I cannot attend the June 17meeting due to previous commitments for my advocacy organization. I have two questions that I hope ACMUI will address during the meeting.
- 1. Have any of your members (on the subcommittee or the whole ACMUI) had any conversations with members of the professional societies regarding the subcommittee report before the June 17 meeting? If so, when did thes e conversations happen and what was communicated?
- 2. Will the NRC and ACMUI reconsider the implementation of qualitative reporting criteria for patient injuries related to radiopharmaceutical extravasation? It is imperative that we maintain objective, transparent, and accurate reporting standards to ensure patient safety and equity in healthcare. Large extravasations that exceed the existing NRC dose thresholds for a reasonable volume of healthy tissue indicate a potential problem in the handling of radioactive isotopes. These should be reported no differently than any other medical event. Not reporting these will continue to allow nuclear medicine centers to avoid improving their processes.
In summary, as a patient advocate, I do not feel that patients are being adequately represented in this process. I reiterate my concerns regarding the proposed rulemaking.
Existing objective medical event criteria should be followed.
Thank you for your attention to this critical matter.
Gina Kell Spehn New Day Foundation for Families FoundationForFamilies.org
1.What term should the NRC use (e.g., extravasation, infiltration) when describing the leakage of radiopharmaceuticals from a blood vessel or artery into the surrounding tissue?
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10 John Witkowski President United Pharmacy Partners 5400 Laurel Springs Parkway Suite 405 Suwanee, GA. 30024 Office: 770-205-2651 Paul E. Wallner, DO, a radiation oncologist, representing the American College of Radiology. Please include my name as participating in the subcommittee Teams call today, and as I indicated in my oral comments, these are the remarks that I would request be appended to the meeting transcript:
For your report of recommendations, the ACR asks ACMUI to consider making these 3 additional recommendations to NRC staff
- 1. Recommend that a radiation injury require medical intervention, such as surgery, to be reported as this proposed Medical Event type. The Commissioners decision explicitly directed NRC staff to focus on radiation injuries requiring medical attention, which indicates a higher level of safety concern than is evident in the draft proposed rule. Importantly, this rulemaking is about what patient data is collected in a federal database without a patients consentit should be of radiation safety significance and of actionable concern to NRC. In this regard, if a CTCAE grade is to be included in the recommendations, the minimum reporting grade should be grade 3.
- 2. Also, for the radiation injury regulatory definition, recommend changing the speculative verbiage can be attributed to radiation to the more explicit has been attributed to radiation or is most likely to be attributed to radiation. Radiation attribution is key. This ensures data is correctly scoped to NRCs authority over byproduct material, and that NRC is not collecting common reactions to sterilization, needle puncture, non- radioactive substances, adhesive, or bandaging.
- 3. In the regulatory language for the new Medical Event type, recommend deleting or has the potential to result in (a radiation injury). This is speculative and likely to result in downstream compliance burden and confusion by investigators or licensees.
Thank you.
Paul E. Wallner, DO
I am providing this written comment and question in response to a noti"cation I received regarding the Nuclear Regulatory Commission (NRC) Advisory Committee on the Medical Uses of Isotopes (ACMUI) meeting scheduled for June 17, 2024.
The notice suggested that persons wishing to provide a written statement should provide their comment by close of business on June 11 (today) and ensure their comment is related to the agenda topic. The topic for the June 17 meeting is the ACMUI subcommittee report o n the NRC stas draft proposed rule and associated draft implementation guidance for reporting nuclear medicine injection extravasations as medical events.
Unfortunately, the subcommittee report was not available on the website. So, as you can imagine, it is dicult for me to ensure my comment is addressing legitimate concerns with the subcommittee report when the public doesnt have access to this report.
So instead, my comment will be focused on the proposed rule and the fact that the NRC and ACMUI are making it extremely dicult for uncon"icted members of the public to eectively weigh in on the report and associated draft implementation guidance (since I dont think we have access to that info). But this approach appears to be consistent with the past processes used by the NRC to draft the proposed rule.
In January 2022, Ms. Mary Ajango and I wrote the NRC regarding the fact that the ACMUI appeared to be con"icted when it came to providing advice to the NRC medical sta regarding the radiopharmaceutical extravasation petition for rulemaking. While we have yet to hear back from the NRC on this issue, we were approached by the NRC Oce of Inspector General because someone within the NRC had a similar concern. We provided the special agents our opinion and provided them with others to approach. While we ar e pleased that the OIG report con"rmed that members of the ACMUI were con"icted and violated federal ethics rules, we are extremely disappointed that the NRC has not addressed these con"icts over the past two years.
For those of you who have not seen the March 2024 U.S. NRC Oce of the Inspector General (OIG) report you can see it here at this link: https://bit.ly/NRCOIG.
The OIG "ndings that two members of the subcommittee should have recused themselves from any discussion on the issue is the tip of the iceberg. Most ACMUI members who have commented on extravasations are also in"uential "gures within medical societies that are actively battling against the eort to raise awareness about extravasations. It is completely unacceptable that these members are providing any guidance whatsoever to the NRC on this topic. From my research of ACMUI members associated with this topic, nearly every member except for the FDA representative and Ms. Laura Weil, the former patient advocate, should have recused themselves. The others held positions or past positions in their respective professional societies that likely in"uenced the drafting of society activities meant to in"uence the NRC to continue to exempt extravasation reporting.
The lack of proactive steps by the NRC to address these con"icts reveals that NRC has little interest in taking the patients side on the issue of extravasation. And unfortunately, the OIG report does not obligate the NRC to take action. While one would hope this OIG report would be enough to convince NRC and the ACMUI to ensure con"icts of interest do not arise in the future, and to take concrete steps to better position itself as a guardian of the patients well-being. Unfortunately, we remain thoroughly disappointed in the NRC and ACMUI response. In an earlier NRC ACMUI meeting this Spring, Mr. Kevin Williams discounted the report and praised the ethics and performance of the ACMUI. It is obvious to patients that the only thing being guarded is the interests of the medical societies. Interests that are clearly at odds with the interests of patients.
Which takes me to my comments on the proposed rule. The proposed rule is inappropriate in so many ways. It is the only medical event or nuclear power safety event that relies on a qualitative reporting criterion. Even worse, NRC is suggesting patients, who have little to zero knowledge of radiation in general and the eects of ionizing radiation on tissue, report a medical event. This "ies in the face of radiation protection tenets. It is a clear example of a failure of NRC sta to protect patients.
Patients will not stand for this. In October 2023, the Patients for Safer Nuclear Medicine (PSNM)
Coalition "led a separate complaint with OIG. We provided OIG "ve speci"c, evidence-backed examples of how NRC has failed to appropriately protect patient safety by disregarding crucial clinical data, propagating factual errors in NRC documents, and more. We are actively working to ensure that the NRC OIG investigates these allegations with vigor. We have also shared these legitimate allegations with members of Congress.
Examples of bias and con"icts of interest clearly exist among those advising NRC. It is abundantly clear to anyone who reads the transcripts of the December 2008 and May 2009 NRC ACMUI meetings on extravasations, that the NRC has mismanaged its policy on nuclear medicine extravasations. NRC heard evidence that extravasations were not virtually impossible to avoid. They heard that patients were receiving high doses that greatly exceeded reporting thresholds. And they heard Dr. Nag say even if patients got a high dose from these preventable medical events, he did not want to be bothered with having to tell the patient, their physician and then have to do all the blah, blah, blah, associated with reporting. When patients see these past meeting transcripts, when we see the subsequent NRC/ACMUI eorts to keep the reporting exemption in place despite knowing the exemption was incorrect, when we see meeting noti"cation shenanigans intended to squelch the patient voice, we know that NRC has failed us. We know we must work with the Inspector General and Congress to hold the NRC accountable.
My "nal input on this meeting is for you all to realize that patients do not trust that you have their best interests in mind when making your decisions. You need to re-earn our trust. My advice is for you to study the evidence. The evidence is clear. If the nuclear medicine community addressed these accidental exposures, like they would if their wife, or child, or father was being extravasated during their important nuclear medicine procedure then they can start improving. Injections are a process like an y other if monitored and if focused on, the process can get better.
Thank you in anticipation of you making the right decisions today.
Best wishes
Simon Davies
Simon Davies Executive Director Teen Cancer America Tel: 310 208 0400 11845 Olympic Blvd. #775W Los Angeles, CA 90064 simon@teencanceramerica.org www.teencanceramerica.org
My name is Stephen Harris and I am a vascular access nurse and the Director of Research and Development for Vascular Wellness. Vascular Wellness is a multi -state vascular access company with a very high understanding of vascular access and the tools, training, and skills required to properly place and maintain vascular access. I have also previously been a clinical educator for Bard Access, a medical device company specializing in vascular access. Furthermore, I am also a co-author of a joint Vascular Access and Nuclear Medicine Te chnologist Expert peer- reviewed paper (https://www.frontiersin.org/articles/10.3389/fnume.2023.1244660/full) on the current nuclear medicine vascular access practices. I also presented these "ndings, before our manuscript was published, at the Annual SNMMI meeting a year ago in Chicago. I believe many members of the NRC medical staff may have been present. If you need to see my credentials, please reach out to me on our company website Since, my position involves an extensive amount of traveling to help hospitals across the Southeast gain access in the most difficult venous access patients, I appreciate the chance to provide a written comment regarding the ACMUI subcommittee report on the proposed NRC rule and guidance for the reporting of large extravasations. In fact, I am drafting this comment now from a hospital based in southern Virginia and I will be traveling on June 17.
I also appreciate the opportunity to comment for another important reason. I have reviewed the credentials of the incredibly august membership of the ACMUI but did not "nd any member who is an expert in vascular access. I have worked in this "eld for ov er 20 years and have extensive experience working with nuclear medicine technologists trying to gain access in nuclear medicine patients. As a result, I feel that I am uniquely quali"ed to provide a vascular access perspective on the extravasation discussion that I have not seen covered by the NRC medical staff, the ACMUI, nor from my review in any of the history of this issue. In fact, the only vascular access connection I have found is a public comment from one of the leading vascular access societies, the Association for Vascular Access (AVA). AVA made several important statements(emphasis added)that should be reconsidered here:
Many adverse outcomes related to vascular access are immediately recognized while others, like extravasation of radiopharmaceuticals, may go unrecognized for a prolonged period of time (sometimes years) and may be associated with negative outcomes including missed diagnosis or suboptimal treatment of nuclear therapy used to treat malignancies.
Clinician education is essential to avoid negative complications associated with venous access. Consistent, evidence-based education is lacking among clinicians who are expected to perform the procedure.
Monitoring a vascular access device for complications like extravasation is a critical responsibility of the healthcare provider. Prevention and reduction of device complications may be achieved through clinician education, evidence-based education, and avoiding blind-stick insertions. Finally, healthcare consumers must be educated about the risks associated with vascular access and enable them to become advocates for safe vascular access in all care settings.
I make these points because I do not have access to the ACMUI subcommittee report on the NRC proposed rule (for some reason I cannot "nd the report that NRC is asking for comments). Without having access to the report, I can only comment on the proposed rule as I know it. And my comments on the proposed rule are in agreement with the AVA - monitoring for a complication like extravasations is a critical responsibility of the healthcare provider. Our Best Practices manuscript clearly shows that nuclear medicine technologists are not using anything close to the current best practices in vascular access. Conversations with nuclear medicine technologists online also show they have not been taught best practices. These knowledge and training gaps indicate that the onus is on the provider to close them. It is not in any way the responsibility of patients. As a vascular access expert, I want to be perfectly clear in my comments.
Putting any responsibility on patients to monitor for or identify when they have been extravasated is entirely inappropriate. It is the responsibility of the nuclear medicine team to monitor for and identify extravasations when they happen. And then take the necessary steps to mitigate patient harm. Waiting to see if extravasated patients report injury has no place in vascular access management and especially when the purpose of vascular access is for the administration of radioactive drugs.
I would also like to make one other observation for the ACMUI and NRC to consider. Recently, a paper was published from the south of India. Nuclear medicine physicians found that without the use of vein "nding technology, their teams were extravasating pa tients with darker skin more frequently than those with lighter skin. Based on my experience, this does not surprise me. And since nuclear medicine technologists rarely use vein "nding technology in the United States, it is highly likely that patients of color are being extravasated at a higher rate than those with lighter color skin. A proposed rulemaking that puts the reporting requirements on patients will lead to an increase in health inequity. It is well known that patients of color are far less likel y to report errors in their care than Caucasian patients.
My view as a vascular access expert is simple. NRC should scrap any idea of having patients play a role in monitoring and reporting poor quality administrations. If the NRC wants to protect patients, I suggest they treat extravasations like any other medic al event. Centers that routinely have extravasations will then be forced to take the steps appropriate for their center to resolve their high rates of extravasation. While this recommendation is not in my best "nancial interest, since I bene"t from helpi ng nuclear medicine technologists gain access in difficult patients, it is absolutely the right recommendation for patients and healthcare.
I welcome any questions from any member of the NRC or ACMUI, and thank you for the opportunity to provide comment. You have my email address.
Stephen Harris CRNI, VA -BC Director, Research and Development Vascular Wellness 919- 623- 0675