Meningitis Outbreak Sweeps Across America…But Where Did It Come From?
In late September, cases of fungal meningitis began to spring up, seemingly out of nowhere, across America.
States such as New Hampshire, New York, New Jersey, Ohio, Michigan, Maryland and Tennessee reported case after case of fungal meningitis.
Experts were baffled as to what was causing the outbreak...especially because the predominant fungus identified in patients was Exserohilum rostratum, which is a rare cause of fungal meningitis. As more states began to report cases of meningitis a pattern began to develop.
All patients suffering from the identified fungal meningitis received an injection of preservative-free methylprednisolone, a steroid injection mainly used to control back pain.
Once the steroid injections were implicated as the potential cause of the outbreak they were traced back to the New England Compounding Center pharmacy in Framingham, Massachusetts, where they were prepared.
After government officials carried out an investigation, they concluded the steroid injections in question were contaminated during preparation and ultimately lead to the outbreak. As the findings of the report were made public one question began to surface...how could this have happened? The short answer is the New England Compounding Center prepared the steroid injections under conditions that were NOT sterile. The long answer is one riddled with controversy and implications towards pharmacy companies putting profit before patient safety.
A compounding pharmacy typically prepares custom medications for individuals based on doctors' prescriptions. In other words, a compounding pharmacy makes medication preparations for individuals that are different from the available mass-manufactured products on a case by case basis. Compounding pharmacies are not supposed to mass-produce medications and ship them out for resale. However, that is exactly what the New England Compounding Center did.
They mass-produced a steroid injection and shipped more than 17,000 vials to pain clinics in 23 states. In essence, the New England Compounding Center turned a compounding pharmacy into a manufacturing company ignoring existing laws, sterility protocols and patient safety all for the speculated goal of profit.
As of November 26, 2012, a total of 510 cases of fungal meningitis, including 36 deaths, have been reported in 19 states across America from the implicated New England Compounding Center's steroid injection.
Although the steroid injection has been recalled and the New England Compounding Center has been shut down the infection rate and death toll continue to rise. With that unsettling news in mind, many are wondering what will be done to prevent future tragedies like this meningitis outbreak from occurring again. Some individuals are calling for stronger state compounding laws while others are lobbying for more government led pharmacy inspections.
Although the public is split on what they ultimately want done they do agree on one point...if the new laws and protocols do not address pharmacy companies placing profit before patient safety it will only be a matter of time before another health care crisis sweeps across America.
Hello, my name is Dr. Macera, PharmD, RPh. I am a clinical pharmacist with over a decade of experience practicing and studying at such institutions as: Harvard University, Northeastern University and Dana-Farber Cancer Institute. I hope to both educate and inform through compelling blog posts.