[ RadSafe ] US shortage of TC-99m

Tue Nov 22 09:18:08 CST 2005

Here is some additional information, courtesy of a colleague.....

Jaro Franta, P.Eng.
Tel.: (514) 875-3444
Montréal, Québec 
frantaj at aecl.ca
web master, CNS-Québec web site
http://www.cns-snc.ca/branches/quebec/quebec.html

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http://interactive.snm.org/index.cfm?PageID=4616&RPID=10
CORAR Releases Notice to the NM Community Regarding Mallinckrodt Recall
Posted November 21, 2005
Source: CORAR
The Council on Radionuclides and Radiopharmaceuticals (CORAR)-an association
comprised of companies in the United States and Canada who manufacture and
distribute radiopharmaceuticals, sealed sources, and radionuclides primarily
used in medicine and life science research-has released the following
information:
November 21, 2005
NOTICE TO THE NUCLEAR MEDICINE COMMUNITY
As you may know, Mallinckrodt has issued a voluntary product recall of its
Ultra-TechneKow® DTE Generators due to issues arising from a routine
sterility assurance process revalidation. Mallinckrodt has indicated that
their generator supply will be affected for a period of four to six weeks.
To date, no adverse events have been reported from these products in the
field.
In the wake of this development the industry is cooperating, as appropriate,
to meet the overall demand for Technetium-99m (Tc-99m) generators in North
America and related patient unit doses, provided through radiopharmacy
distributors, which use this critical isotope. This includes production
scale up for both Tc-99m generators and Molybdenum-99, the raw material
isotope. At this time, it is anticipated most of the market shortages for
Tc-99m generators and Tc-99m unit doses should be met beginning Monday,
November 28. Varying degrees of market shortages of Tc-99m will continue to
be experienced during Thanksgiving week, although unit dose shortages should
be reduced as the week progresses as additional supply of Tc-99m generators
is
manufactured by Bristol-Myers Squibb Medical Imaging.
The possibility exists for sporadic shortages to still occur over the next
month or so, due to one company not being able to assure total supply of
market demand. With only one manufacturing site, other influencing factors,
such as winter weather, may affect availability of Tc-99m generators and
Tc-99m unit doses.
Should there be questions related to how this dynamic and evolving situation
affects your facility, please contact the appropriate company sales
representative for further specifics. CORAR will provide additional
information, related to market supply of Tc-99m generators and Tc-99m unit
doses, as it may develop.
Thank you for your understanding and assistance.
============================

http://interactive.snm.org/index.cfm?PageID=4613&RPID=10
Mallinckrodt Issues Voluntary Recall of Technetium Tc-99m Generators
Posted November 19, 2005
On Nov. 18 Mallinckrodt issued a voluntary product recall on its
Ultra-TechneKow(R) DTE generator (Technetium Tc-99m generator) with a
request for immediate discontinuation of use of any of its generators in the
market. This recall came as the result of a routine sterility assurance
process revalidation.
This is an issue of great concern for the nuclear medicine community. It
will
affect many of our patients, necessitating rescheduling or alternative
treatment
for non-critical procedures. Mallinckrodt has indicated that patient doses
should
not be formulated from any of its generators and that generator availability
will be
affected for a minimum of six weeks. No adverse events related to the recall
have
been reported. SNM will work with Mallinckrodt in the coming days and weeks
and offer our full support in any way possible.
Mallinckrodt has sent a letter to its customers accompanied by a question
and
answer sheet; click on the links below to access them.
As we learn more, we will keep you informed so we may continue to provide
the
best care for those who depend on our services. We will use e-mail and our
Web
site to communicate to you any further news or developments.

Peter S. Conti, M.D., Ph.D.
Valerie R. Cronin, CNMT, FSNMTS
============================

http://imaging.mallinckrodt.com/products/product.asp?ProductID=49
Indications and Applications
Sodium Pertechnetate Tc 99m is used IN ADULTS as an agent for: Brain Imaging
(including
cerebral radionuclide angiography), Thyroid Imaging, Salivary Gland Imaging,
Placenta
Localization, Blood Pool Imaging (including radionuclide angiography),
Urinary Bladder
Imaging (direct isotopic cystography) for detection of vesico-ureteral
reflux, and Nasolacrimal
Drainage System Imaging (dacryoscintigraphy).
Sodium Pertechnetate Tc 99m is used IN CHILDREN as an agent for: Brain
Imaging (including
cerebral radionuclide angiography), Thyroid Imaging, Blood Pool Imaging
(including
radionuclide angiography), Urinary Bladder Imaging (direct isotopic
cystography), for the
detection of vesico-ureteral reflux. Refer to package insert at link below
for more information.
========================

November 18, 2006
Mallinckrodt has initiated a voluntary recall of our DTE generator
(UltraTechneKow ).
We have anticipated questions our customers may have related to Tc 99m
generator
supply issues. Our answers are provided below.

How will this information be communicated to Mallinckrodt customers?
A formal recall notice was distributed on November 18. Additional customer
letters with
instructions on product returns and further information will follow.

Why are we having the recall?
This voluntary recall is being conducted as a result of sterility issues we
identified during
routine sterility assurance process re-validation at Mallinckrodt's
radiopharmaceutical
manufacturing facility.

How were the issues identified?
Mallinckrodt conducts periodic sterility assurance evaluations on process
equipment as
part of their standard operating procedure. Results from recent tests did
not meet
established criteria.

What is the extent of the recall?
The voluntary recall covers all Mallinckrodt generators with a request for
immediate
discontinuation of use of any Mallinckrodt generators in the market.
Instructions on
product return will follow.

Will it extend to the patient level?
Patient doses should not be formulated from any Mallinckrodt generators at
this time.
No adverse events related to the recall have been reported.

How long is Mallinckrodt expected to delay production?
Mallinckrodt is committed to taking whatever steps are necessary to ensure
the safety
of all of our products and will strive to resume production as soon as
possible.
Remedial actions including successful re-validation of the affected process
will take a
minimum of six weeks to complete. We will periodically update the market of
our
progress in resolving the issue.

What steps are being taken to supply nuclear pharmacies and customers with
generators?
We are currently evaluating every possible solution for the supply issues
that have
arisen. In addition to pursuing the earliest resolution of our manufacturing
issues, we
have initiated plans with alternative suppliers for our pharmacies and
customers.

Can the demand for technetium be mediated?
Since cardiology comprises a major portion of technetium usage, utilizing
Thallium for
cardiac scans, where medically appropriate, would enable cardiac nuclear
scans to
continue with less overall technetium. This would reserve the limited Tc
supply for
procedures where no acceptable substitution can occur.

What alternative imaging modalities can be used?
We are currently working with industry groups and societies such as SNM and
ASNC to
provide guidance on appropriate alternatives for existing procedures.

Will these problems keep occurring in the future?
Mallinckrodt Nuclear Medicine places the highest priority on patient safety
and quality
assurance. In early 2004, we began investing over $100 million in our
Maryland
Heights facility to assure our commitment to providing safe, reliable and
efficient manufacturing.

Were any adverse events reported to prompt this action?
No adverse events related to this recall have been reported.

What capacity exists to supply the market while Mallinckrodt is not
producing generators?
Mallinckrodt is currently communicating with alternative manufacturers to
assess and
assist their ability to supply the marketplace.

When will Mallinckrodt pharmacies be able to obtain generators for use in
unit dose preparations for customers?
We expect to have limited technetium supply from other vendors available to
produce
doses as early as Tuesday, November 22 throughout our network of
Mallinckrodt nuclear pharmacies.

What steps is Mallinckrodt taking to provide customers with generators?
We are working collaboratively with the industry to maintain generator
availability for the
marketplace, including our own pharmacies. In the interim, customers needing
generators should contact Bristol-Meyers Squibb as an alternate supplier.

Are any other products impacted?
No other products are affected by this recall.

Who can we contact regarding product quality issues or patient adverse
events?
If any adverse events occur with our products, they should be instructed to
call
Mallinckrodt corporate product monitoring at 888-744-1414, option 2 then,
option 1.
==================

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