Contaminated Drug Lawsuit
Action taken against pharmacy that failed to recall contaminated drugs.
Jefferson City News Tribune, MO - 12 Mar 2003
PLATTE CITY, Mo. (AP) -- 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.
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 drugmakers.
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.
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