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This is an e-mail sent out by The Cystic Fibrosis Foundation
regarding the contaminated solutions.
Dear Care Center Director,
Please be advised that a mail-order pharmacy in Missouri called Med 4
Home Pharmacy recently distributed a compounded drug called Albuterol//Ipratropium
inhalant solution that had been contaminated with B. cepacia. Approximately
19,000 people may have received the contaminated compound. At this point,
we have no way of knowing how many people who received this drug have
cystic fibrosis. If you or anyone else at your care center has prescribed
this solution in the past several months, we recommend that you alert
the recipients and inquire from which pharmacy they received this product
so that appropriate action can be taken. If a patient has received this
solution from Med 4 Home Pharmacy, they should be cultured for B. cepacia
as soon as possible and monitored thereafter. For more information, please
see the article below.
Sincerely,
Preston W. Campbell, III, M.D. Bruce C. Marshall, M.D.
The Associated Press State & Local Wire
March 12, 2003
Action taken against pharmacy that failed to recall contaminated drugs.
PLATTE CITY, Mo. The Missouri Board of Pharmacy has won a restraining
order against a Kansas
City pharmacy that failed to properly recall contaminated drugs. A Platte
County judge issued the restraining order Tuesday against Med 4 Home
Pharmacy and said the order would be in effect until March 21.
Med 4 Home Pharmacy failed to properly recall contaminated drugs that
the company had compounded, said Kevin Kinkade, the state board's executive
director.
The pharmacy company also on March 5 denied a pharmacy board inspector
access to its compounding areas, which Kinkade said violated state law.
The restraining order forces the company to stop compounding the drugs.
A spokeswoman for the pharmacy would not comment.
As many as 19,000 patients nationwide might have received the contaminated
drug - an Albuterol//Ipratropium inhalant solution to treat chronic
lung diseases, such as emphysema and asthma, Kinkade said. Another compounded
inhalant, Budesonide, also may have been contaminated. A routine state
inspection revealed a bacteria contaminant - Burkholderia cepacia -
in some of the product, Kinkade said. According to recent research by
the Centers for Disease Control, the bacteria is particularly dangerous
for patients suffering from cystic fibrosis, in some cases producing
a fast-moving, invasive and fatal infection.
Kinkade said the board had not received notice from any patients who
became sick because of using the contaminated drugs. The pharmacy initially
recalled only parts of the batches that it thought had been contaminated,
instead of the entire product, Kinkade said. He also said the pharmacy
had not properly notified patients of the problem. "This is an
issue of public health and safety," Kinkade said. "Certainly
a patient on these drugs may already be in a compromised state, and
if you introduce an organism into their lungs, it could become pathogenic."
Compounded drugs are not the brand-name prescription drugs that people
routinely buy at chain drugstores. Instead, compounded drugs are customized
medications, usually mixed in independent pharmacies and without the
same safety procedures followed by big drug makers. The mail-order pharmacy
employs about 250 workers locally.
The state pharmacy board has contacted the FDA. A second court hearing
was scheduled for March 21.
Allison M. Tobin
Director of Media Relations
Cystic Fibrosis Foundation
6931 Arlington Road
Bethesda, MD 20814
atobin@cff.org
ph: (301) 841-2665
(800) FIGHT CF
fax: (301) 951-6378
http://www.cff.org
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