Re: Radioisotope misadministrations

[carol marcus <csmarcus@ucla.edu>]

At 10:30 AM 5/12/99 -0500, you wrote:
>The report of the US Nuclear Regulatory Commissionon 
>radioisotope misadministrations in FY1996 actually totaled 
>13 occurrences in brachytherapy and 7 in nuclear medicine.  
>I strongly suspect that these are the result of human 
>error, although use of inadequately trained personnel could 
>have been a factor.  Such accidents are intolerable and all 
>efforts must be made to eliminate them.
>It is informative to put these data in context.  It has 
>been estimated that some 7.5 million nuclear medicine 
>procedures and about 700,000 brachytherapy procedures are 
>performed per year in the US.  Thus the misadministration 
>rate (order of magnitude)is about one per million for 
>nuclear medicine and ten per million for brachytherapy.  
>These are "small number statistics" and I suspect that 
>there is no significant difference between these two rates. 
>I further suspect that these rates are probably lower than 
>those for misadministration of medicine, either from error 
>in prescribing by the physician or error in providing the 
>prescribed medication by the pharmacist.
>All possible effort should be made to eliminate these 
>errors.  However, it is unlikely that human perfection can 
>ever be achieved.  We readily accept imperfection in most 
>human activities--but not medicine.
>***********************************************************
>S. Julian Gibbs, DDS, PhD               Voice: 615-322-3190
>Professor of Radiology                    FAX: 615-322-3764 
>Dept. of Radiology & Radiological Sciences
>Vanderbilt University Medical Center
>Nashville TN 37232-2670 Email:s.julian.gibbs@vanderbilt.edu
>***********************************************************
>If it's free, it's advice;
>If you pay for it, it's counseling;
>If you can use either one, it's a miracle!
>
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Dear Radsafers:

I believe that Dr. Gibbs' comments concerning byproduct medical
misadministrations are not rationally supportable.  I shall address most of
my comments to the nuclear medicine portion of his statements, as that is
where my expertise lies.  

Most of NRC's precious "misadministrations"---and I say "precious" because
it is these that rationalize NRC's dysfunctional "medical" program---are not
medical mistakes at all.  NRC sets an arbitrary and medically nonsensical
limit for underdosing and overdosing, and defines "sin" as anything beyond
that percentage  limit.  The fact that perfectly good medical practice in
nuclear medicine is compatible with much larger variation is irrelevant to
NRC, which has no knowledge of medicine and refuses to listen to those who
do.  So, those "misadministrations" that are merely percentage games should
be discounted from the total.  In any case, they cause no medical problems.
Once in awhile a patient gets a diagnostic survey with I-131 instead of a
diagnostic thyroid scan with I-123.  Whether or not the patient was harmed
depends upon the underlying disease. Patients with hyperthyroidism or
thyroid cancer are not harmed, because they will get even more I-131 anyway.
Rarely the wrong patient is treated, usually because the patient answers to
the wrong name or there are two patients with the same name.  The bottom
line is that out of 10-13 million nuclear medicine procedures performed per
year in the United States, there is about one medical mistake per year that
significantly harms a normal thyroid gland, and this individual needs to
take a thyroid pill once a day for life in order to maintain a normal
thyroid hormone level.

Medical errors of significance occur at such an incredibly low rate because
of the intrinsic safety of radiopharmaceuticals and the competency
requirements of the users.   

Nevertheless, Dr. Gibbs states that "All possible effort should be made to
eliminate these errors."  I disagree.  One could spend unlimited quantities
of money in this area, and would accomplish nothing.  The significant error
rate is as low as it is going to go without obliterating the practice of
nuclear medicine altogether.  Even the NRC, in analyzing its predictably
failing "Quality Management" Rule, admitted in its report that the rule had
no effect on rates of mistakes.  The rule, which has nothing to do with
"quality" OR "management", basically turns human error into an illegal act,
to be vicously punished by a dying agency with zero medical intelligence and
a strong propensity to lie or severely spin-doctor the truth for its own
political gain.

Dr. Gibbs' statement that "We readily accept imperfection in most human
activities---but not medicine." is downright foolish.  As long as there are
humans, there will be human error.  I have met thousands of physicians, and
not a single one was ever perfect. While we try to devise systems to
decrease mistakes with significant medical consequences, obliteration is not
an intellectually respectable endpoint.  The fact that it is NRC's endpoint
does not add any respectability to what is an intrinsically silly idea.

When one compares error rates in medicine, one finds that byproduct medicine
is much less error-prone than other medical specialties.  Medication errors
in hospitalized patients of NON-radioactive drugs reach about 30% of
patients, and many of these errors result in significant increases in
morbidity and mortality.   This difference appears to be due to the
qualifications of the users.  Even in brachytherapy, where the sources are
much more potentially dangerous than ordinary radiopharmaceuticals, the
medically significant error rate is low.  NRC artificially inflates the
error rate here too, in that patients who move or remove their brachytherapy
sources create "misadministrations" which NRC blames on the physicians. The
fact that most brachytherapy mistakes do not cause harm to the patients is
not generally conceded by NRC.  

In summary, Dr. Gibbs' contention that all possible effort should be
expended to wipe out byproduct misadministrations shows that he does not
understand the nature of the "misadministrations", the reality of human
error, or cost/benefit tradeoffs in the medical sector.


Ciao, Carol

Carol S. Marcus, Ph.D., M.D.
Director, Nuclear Medicine Outpatient Clinic
Harbor-UCLA Medical Center
Torrance, CA 90509

<csmarcus@ucla.edu>


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