RE: "the CIS product", I-131 therapy solution, IS supplied

[carol marcus <csmarcus@ucla.edu>]

At 01:31 PM 4/24/00 -0500, you wrote:
>Just a quick reminder, NaI stabilization only works in liquid form. Capsules
>are not stabilized, only qausi contained. Both HI and I2 evolve from the
>dried material. Buffers don't function in a dry world.
>
>-----Original Message-----
>From: ptyree@cisusinc.com [mailto:ptyree@cisusinc.com]
>Sent: Friday, April 21, 2000 4:33 PM
>To: Multiple recipients of list
>Subject: "the CIS product", I-131 therapy solution, IS supplied 
>
>
>
>
>
>Carol S. Marcus, Ph.D., M.D.
>Harbor-UCLA Research and Education Institute <csmarcus@ucla.edu>
>wrote....."There is no intellectually valid reason to perform thyroid
>bioassays
>on
>any technologist or physician who administers NaI-131 in either capsule or
>liquid form.  All commercially available preparations are stabilized against
>volatility except for the CIS product, and that is stabilized by Syncor
>before dispensing."
>
>The SODIUM IODIDE I 131 SOLUTION For Oral Theraputic Use manufactured by CIS
>bio
>international (NDA 17-315) is described in its package insert (December
>1995)
>"..as a stabilized aqueous solution for oral administration..contains 2.48
>mg/mL
>sodium thiosulfate buffer and 4.2 mg/mL phospate buffer...pH has been
>adjusted
>to between 7.5-9.0 with sodium hydroxide." The entire P.I.content is
>available
>at www.cisusinc.com
>
>This "CIS product" is also routinely supplied to most other chain and
>independent radiopharmacies in the U.S.
>
>Thank you for your support.
>
>Paul Tyree, RSO
>CIS-US, Bedford, MA
>781/275-7120 x 3020
>ptyree@cisusinc.com
>
>
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Dear Radsafers:

The liquid NaI-131 is stabilized before being added to the absorbent
material in the capsule.  The measurements of volatility performed in
multiple radiopharmacies with both liquid and capsule preparations showed
low volatility for both, but lower volatility for capsules than liquid.

The important thing is that whatever is being done is enough to insure that
no hazardous amount of I-131 gets to the thyroids of workers, and in fact,
no amount close to the regulatory limits gets there, either.  How many
hundreds of thousands of negative readings does it take to convince health
physicists that (1) nobody needs them to perform or supervise or record
these pointless thyroid bioassays, and that (2) the health care sector has
no money available to waste on such senseless busywork?  Just because a few
people have documented insignificantly small quantities of I-131 in worker
thyroids does not mean everyone should waste their time doing these
measurements.  It means that we now have data to show that it isn't a
problem, so no one should waste time and money doing these bioassays, making
believe they're "protecting" us or "just being careful".

Ciao, Carol

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

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