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Re: medical misadministration of I-131



At 11:24 PM 8/11/99 -0500, you wrote:
>I would be very curious to hear C. Marcus' opinion of such situations.  I
>hope she's out there and monitoring this thread.  In my opinion she's more
>than qualified to address these kinds of things given her background and
>involvement in the such regulatory issues.
>
>
>dmperrero@msn.com
>I'm with the government, I'm here to help....
>
>
>Dear Radsafers:

Yes, I have been following this "misadministration" thread, a situation
which I have actually studied very hard for about 17 years.  I also
participated as a consultant to NRC after these events for two terms on the
ACMUI, and have consulted within California as well.

Therapy misadministrations in Nuclear Medicine are rare; several a year with
roughly 60,000 or so therapy administrations.  For comparison, the number of
nonradioactive drug mistakes in hospitals is 10-30 PER CENT of drug
administrations, and many of these cause deaths or severe morbidity.  Most
of the mistakes with non-radioactive drugs are due to busy staff, many of
whom are undertrained.  Given the shrinking dollars used for medical care,
most institutions try to "get away" with the lowest quality (and therefore
cheapest) workers they can.

In Nuclear Medicine, many states have requirements that the technologists be
certified.  This helps, although certification alone does not insure that a
Nuclear Medicine technologist is qualified to administer therapy doses of
radionuclides.  The therapy training of many technologists is minimal.  The
real weakness in Nuclear Medicine is the Authorized User physician, most of
whom are not board certified in Nuclear Medicine.  About 80 % of Nuclear
Medicine is performed by diagnostic radiologists, whose training in Nuclear
Medicine is very limited and de facto shrinking every year, as more and more
diagnostic radiological procedures claim the time of a resident in training.
Nuclear Medicine therapy training suffers most (as opposed to diagnostic),
and even those few diagnostic radiologists who take an extra year of Nuclear
Radiology are often lacking in therapy knowledge.  Therapy training is not
required for Nuclear Radiology.  In addition, most radiologists feel
uncomfortable being directly responsible for patient management, and do not
want patient contact at all.  This is becoming a real problem, because the
nature of therapy Nuclear Medicine requires physician participation with the
patient, and all too often this does not occur if a diagnostic radiologist
is in charge.  Everything is dumped on the technologist, who is not
qualified to practice medicine.

In the "misadministration" that recently caught everyone's attention, the
thing that stood out in my mind was, "Where was the doctor?".  The
Authorized User physician should have been explaining the therapy to the
patient, explaining to the patient that she would most likely require
synthroid for life as the radiation will destroy the whole thyroid gland in
most cases.  The physician should have been going over the patients
medications, making certain that nothing was going to interfere with the
NaI-131.  The physician should have made certain that the patient had
appropriate follow-up appointments, and should be explaining the possible
side effects of the radioiodine.  Had the patient been younger, the
physician should have checked the pregnancy test and asked about lactation.
It is also a good idea for the physician to check the dose in the dose
calibrator, check the patient's identity, and then have a good, sensible
talk about radiation safety precautions.  I give all of these tasks to my
technologist, and then I either repeat them myself or have a resident do it
as well and then repeat at least part of it again myself anyway.  I have
stopped a few misadministrations in the making merely by checking the work
of a technologist and/or resident.  And, I have found that few technologists
can give a good radiation safety talk to a patient that is personalized for
that patient, and that practically no technologists can talk intelligently
to a patient about drug interactions.  Often, it is necessary for the
physician to write a prescription for a beta blocker at the time of the
radioiodine administration, because no one else has done so. I can not
imagine Nuclear Medicine therapy being performed without a competent
physician present and working.  In California, the regulations require the
Authorized User physician to be physically present when a therapy dose is
administered.  This has essentially wiped out therapeutic
misadministrations.  We haven't had any in 6 years except for one in which
the physician was not present, despite the requirement to be there.  We do
not have NRC's repugnant "Quality Management" Rule, which did not accomplish
anything at all, according to the NRC's own review.  When one realizes that
20% of American Nuclear Medicine is practiced in California, our low therapy
misadministration rate shows that planting a responsible physician right
there really works.  The odds that the physician will make the same mistake
the technologist made is low.

So, while human error will be with us as long as there are humans, it can be
minimized by having competent professionals performing the task and the
active participation of the Authorized User physician.

You will notice, if you look into it, that most Nuclear Medicine therapy
misadministrations occur in practices in which the Authorized User physician
is a diagnostic radiologist with minimal training who basically assigns his
technologist the responsibility of doing everything.  The few
misadministrations that occur in practices run by board-certified Nuclear
Medicine physicians are really weird and represent amazing human error most
of the time.  

Unfortunately, NRC relies on User Fees to survive, and must sell as many
licenses as possible, at exhorbitant rates, in order to keep its bloated
bureaucracy alive.  NRC will never stop licensing diagnostic radiologists to
perform Nuclear Medicine, because NRC is desperate for the money.  NRC does
not really care if the diagnostic radiologists are competent or not, and
chickened out of the plan to give a comprehensive radiation protection
science exam to them probably because if they flunked NRC would have to
fight the American College of Radiology, which NRC is scared to do.  Also,
NRC would not want to end its precious "misadministrations", because this is
how it suckers the public and the Congress into keeping the program around.
In 1985 there were 0.7 FTE in the Medical Section at NRC.  Now, about 30
bureaucrats, none of whom have any competence in Nuclear Medicine or Nuclear
Pharmacy, have suckered 5 medically and pharmaceutically incompetent
Commissioners into keeping them employed.  When NRC hired the NAS-IOM to
study its "Medical" Program, the Academy was astounded at the pointlessness
and viciousness of the thing, and recommended that NRC's program be removed
by law, because it was protecting no one and was possibly harmful to
patients.  The NAS-IOM also recommended that the regulation go to the
States, and that the training and experience required for Nuclear Medicine
therapy be INcreased.  As we can see by NRC's latest disgusting draft of the
new, hideous Part 35 (not to mention the licensing policy, which is a
confidential NRC document which it will not share with the public), training
and experience for Nuclear Medicine therapy is being DEcreased.  It is
painfully obvious that NRC is not interested in improving the quality of
Nuclear Medicine by improving the quality of the physicians it licenses.
The more physicians it licenses, the more money it gets.  The more limiting
your disgusting license, the more money it gets in Amendment Fees.  The
dumber the docs and the more mistakes that are made, the more staff keep
their jobs writing dumb regulations that purport to "cure" human error.
They never work, because the root cause is poorly qualified physicians to
begin with, and in many states, poorly qualified techs (no certification
required). The newer regulations basically seek to criminalize human error,
which shows you how stupid the NRC had become.  None of these errors are
purposeful, and criminalization serves no purpose other than to bring in
lots of other useless NRC bureaucrats who have to justify their existence,
too.  It is a real shame that the President does not choose Commissioners
with enough brains, education, experience, and management talent to avoid
being cuckolded by their staff, management, and lawyers.  We could certainly
use some intelligent life on the 17th and 18th floor.  I'll bet that none of
them have personally read and understood the monumental change in licensing
procedures, philosophy, and policy that the staff cooked up and is quietly
pushing through.  I thought Commissioners were supposed to make policy
changes, especially if these policies were to have profound ramifications in
the Medical Program.  I thought they were supposed to make such policies
public, and discuss them with the ACMUI.  How many of YOU have read
SP-99-037?  If there are any competent Commissioners at NRC, they ought to
hang everyone who wrote, signed off on, and reviewed that policy for legal
purposes.  

Well friends, that is what I think of misadministrations, and what I think
of the Agency that is indirectly causing them.

Ciao, Carol

Carol S. Marcus, Ph.D., M.D.
<csmarcus@ucla.edu>
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