In an article in the Annals of Internal Medicine, Dr. John R. Perfect of Duke University Medical Center in Durham, N.C., said in 2002, the Centers for Disease Control and Prevention in Atlanta detailed five cases of Exophiala Wangiella dermatitidis meningitis or arthritis related to contaminated, injectable, preservative-free methylprednisolone acetate prepared from a compounding pharmacy.
In the current fungal meningitis outbreak, which has resulted in 23 deaths, U.S. health officials confirmed the fungus Exserohilum rostratum was detected in unopened vials of a preservative-free steroid -- methylprednisolone acetate. About 17,000 doses of the steroid were shipped from the New England Compounding Center in Framingham, Mass., and an estimated 14,000 were used in treatment to ease back and joint pain. Patients have become ill about one to four weeks following the injection, but health officials said the fungus can take time to develop so there could be cases for months.
Perfect said the fungus in the 2002 meningitis outbreak was different, but the same steroid was made by a compounding pharmacy and contamination by fungus resulted patients becoming ill.
"I was involved in the recognition and management of some of these patients. We learned, or thought we learned, several important lessons from the outbreak: that compounding of preservative-free corticosteroids requires meticulous sterility to ensure lack of fungal contamination; in the absence of that level of sterility and in an environment of highly concentrated steroids, fungi grow aggressively," Perfect wrote in the letter.
"We also learned that the incubation period for appearance of disease from the time of exposure could be up to six months, that many persons in several states were exposed but the attack rate for disease was low and the drug voriconazole successfully treated these cases of iatrogenic fungal meningitis except for one fatality."
However, the cost in patient worry and suffering, medical expense and public health surveillance of the 2002 outbreak was high, and the public's trust that medications are safe from microbial contamination was shaken, Perfect added.
Patients will need to be followed closely and management refined on a case-by-case basis for some time to come, Perfect said.
"A full decade after the 2002 fungal meningitis outbreak, we are again painfully reminded of the importance of sterility and the powerful disease-producing interactions between corticosteroids and fungi. Even at this early stage in the epidemic, it is clear that issues surrounding pharmacy compounding and its regulation will need to be revisited at the state and federal levels," Perfect wrote.
"Productive discourse between pharmacy societies, the Food and Drug Administration, the pharmaceutical industry, and the legislatures can hopefully balance the demand for individualized, designer products for patient care against the risks for outbreaks that cause suffering and death and that erode trust in public health systems. Otherwise, this will surely happen again."
The CDC said Tennessee was the first state to identify the fungal meningitis and had the most cases at 69 and nine deaths, followed by: 62 cases in Michigan and five deaths; 41 cases and two deaths in Virginia; 40 cases in Indiana and two deaths; 17 cases and one death in Maryland; 17 cases and three deaths in Florida; seven cases in Minnesota; 10 cases in New Hampshire; 11 cases in Ohio; 11 cases in North Carolina and one death; 16 cases in New Jersey, one case in New York; one case each in Idaho, Illinois, Texas and Pennsylvania.
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