Meningitis outbreak leads to pharmacy regulation questions
Last Updated: 218 days ago
INDIANAPOLIS - At the Guyer Institute on Indianapolis' north side, 400 doses of medication are mixed a month. One mistake in the process and the entire batch of drugs can be ruined, which is what happened with the Massachusetts company that made the steroid injections tainted with fungal meningitis.
"It's kind of a separate air system to prevent any kind of microbes or bacteria from entering and then we follow specific guidelines," said pharmacist Chris McNullen, who works at the Guyer Institute.
Other precautions include employees wearing hair nets, gowns, booties and gloves, and all products must pass a sterility test.
"We send out regularly a portion of our batches for microbe tests, testing for bacteria, fungus and other things that don't belong," McNullen said.
But now questions are mounting about the New England company allowed to mix batches of specialized medicine without FDA oversight.
Pressure is mounting to increase oversight of similar companies.
Amy Peak, with Butler University's pharmacy school, said, given the volume of steroid being produced, the so-called compound pharmacy should have been labeled and regulated as a manufacturing plant.
"Most compound factories are not doing the manufacturing on this type of scale," Peak said. "This isn't the most common type of drug that is made in a compounding firm. If you use one of our compound pharmacies don't be afraid. These are safe facilities."
But six Indiana facilities bought the steroid injections from the Massachusetts company, which is licensed as a non-resident pharmacy.
The Indiana Board of Pharmacy relies on other boards to regulate licenses in their jurisdiction.
In light of the outbreak, the board has turned the matter over to the Indiana attorney general.
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