Re: US - 31 dead, 424 infected with fungal meningitis in 19 states
Re: US - 31 dead, 424 infected with fungal meningitis in 19 states
The information in this article is based on the NEJM report published earlier this week.
150 patients got old drugs in meningitis outbreak
Nearly 150 patients exposed to potentially contaminated steroid injections in Tennessee received medicine more than 7 weeks old, even though industry guidelines say its shelf life should have been no longer than 24 hours.
Almost 1 in 5 of those patients developed a fungal infection ? a rate dramatically higher than for those treated with fresher medicine, according to the Tennessee Department of Health.
...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, the compounding center'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 preservative-free steroid should never have been produced en masse to begin with, said Loyd V. Allen Jr., editor-in-chief of the International Journal of Pharmaceutical Compounding.
"If it is not preserved ? if it is only intended to be used in one patient ? then it has to be packaged in a single-use container and its contents have to be used all at one time," Allen said. "If it is going to be used on multiple patients or at multiple times, then it has to have a preservative."
The company shipped 17,676 units of preservative-free methylprednisolone acetate that have been linked to the outbreak. A sterility test should be conducted for any batch larger than 25 units, Allen said.
The state health department's analysis of infection cases in Tennessee found that patients treated with medicine packaged longer than 50 days had a 19% infection rate while those treated with newer vials had only a 3% infection rate.
"We found a strong association between the age of methylprednisolone vials and the rate of infection in one clinic," the physicians wrote. "One possible explanation for this observation is that the level of contamination in the vials may have increased over time with subsequent higher fungal burdens present in older vials."
The article does not identify the clinic by name but does note that the clinic had used 1,663 vials of the medicine. The only one of the three clinics in Tennessee that had that much product, according to prior information from the state health department, was St. Thomas Outpatient Neurosurgery Center.
However, Allen said the responsibility for providing guidance on shelf life rests with the drug manufacturer or compounding lab. The best-practice standards do allow compounding labs to recommend usage for up to six months if certain criteria, including a program for sterility testing, are met..."
