Old Injections Given to Many in Meningitis Outbreak
In yet another shocking revelation involving the meningitis outbreak, it has been disclosed that around 150 patients from Tennessee were given potentially tainted steroid injections that were more than seven weeks old, despite industry guidelines stating that the maximum shelf life of the compounded drug is 24 hours at room temperature.
Fungus-contaminated methylprednisolone acetate from the New England Compounding Center (NECC) has been held responsible for the nationwide meningitis outbreak that has sickened more than 400 people and killed 31 from 19 states.
The Nashville Tennessean reports that 1 in 5 of those patients who received the older medication contracted fungal meningitis, a rate that was much higher when compared to those who were administered fresher medication, according to an analysis of cases by the Tennessee Department of Health. Only 3 percent of those who received medicine packaged for less than 50 days were found to have contracted the disease versus an infection rate of 19 percent in those who received older medication.
Industry norms require a sterility test for drug batches larger than 25 units. The company shipped 17,676 units of preservative-free methylprednisolone acetate, reports The Tennessean. NECC says it ran sterility tests on the drugs but that claim has been questioned by the Massachusetts Board of Pharmacy, which says the testing done was inadequate.
Drugs consisting of non-sterile ingredients and lacking antimicrobial preservatives—as was the case with the tainted steroids from NECC—are considered “high risk” products according to the best-practice guidelines from the U.S. Pharmacopeia Convention. The guidelines state that the shelf storage time for such a drug should not exceed one day at room temperature or three days at a cold temperature, writes The Tennessean.