Written By comlim on Kamis, 08 November 2012 | 22:34
By Tom Wilemon and Walter F. Roche Jr. | The Tennessean
Nearly 150 patients who were exposed to potentially contaminated steroid
injections in Tennessee got medicine that was more than 7 weeks old, even though
industry guidelines say its shelf life should have been no longer than 24
hours.
Almost one in five of those patients developed fungal infection -- a rate dramatically higher than for those who were treated with fresher medicine, according to the Tennessee Department of Health.
The methylprenisolone acetate produced by Massachusetts-based New England Compounding Center is blamed in a nationwide outbreak of fungal meningitis that has sickened 424 people and killed 31, including 13 in Tennessee.
Under best-practice guidelines from the U.S. Pharmacopeia Convention, the drug would be considered a "high-risk" product -- made from nonsterile ingredients and lacking antimicrobial preservatives. In the absence of a sterility test, storage time should not exceed one day at room temperature or three days at a cold temperature, the guidelines say.
In Tennessee, NECC's vials were stored at room temperature, as specified in the package instructions, state health officials said in a paper published Tuesday in the New England Journal of Medicine.
The compounding laboratory claimed to have performed sterility tests on its products, but the Massachusetts Board of Pharmacy has said that testing was inadequate and shipments were made before the safety of medicines had been verified.
Continue reading here
Almost one in five of those patients developed fungal infection -- a rate dramatically higher than for those who were treated with fresher medicine, according to the Tennessee Department of Health.
The methylprenisolone acetate produced by Massachusetts-based New England Compounding Center is blamed in a nationwide outbreak of fungal meningitis that has sickened 424 people and killed 31, including 13 in Tennessee.
Under best-practice guidelines from the U.S. Pharmacopeia Convention, the drug would be considered a "high-risk" product -- made from nonsterile ingredients and lacking antimicrobial preservatives. In the absence of a sterility test, storage time should not exceed one day at room temperature or three days at a cold temperature, the guidelines say.
In Tennessee, NECC's vials were stored at room temperature, as specified in the package instructions, state health officials said in a paper published Tuesday in the New England Journal of Medicine.
The compounding laboratory claimed to have performed sterility tests on its products, but the Massachusetts Board of Pharmacy has said that testing was inadequate and shipments were made before the safety of medicines had been verified.
Continue reading here
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