How did steroids get contaminated? Was the fungus in the chemical powder or liquid it was mixed with?

By Mike Stobbe / The Associated Press

Published: October 17. 2012 4:00AM PST


NEW YORK — Was it some moldy ceiling tiles? The dusty shoes of a careless employee? Or did the contamination ride in on one of the ingredients?
There are lots of ways fungus could have gotten inside the Massachusetts compounding pharmacy whose steroid medication has been linked to a lethal outbreak of a rare fungal form of meningitis.
The outbreak has killed at least 15 people and sickened more than 200 others in 15 states. Nearly all the victims had received steroid injections for back pain.
Federal and state investigators have been tightlipped about any problems they may have seen at the New England Compounding Center or whether they have pinpointed the source of the contamination. They did disclose last week that they found fungus in more than 50 vials from the pharmacy.
Company spokesman Andrew Paven said by email that criminal investigators from the Food and Drug Administration were at the pharmacy in Framingham, Mass., on Tuesday. The visit was part of a broad federal and state investigation of the outbreak, FDA spokesman Steven Immergut said in an email.
New England Compounding has not commented on its production process or what might have gone wrong, so outside experts can only speculate. But the betting money seems to be on dirty conditions, faulty sterilizing equipment, tainted ingredients or sloppiness on the part of employees.

The drug at the center of the investigation is made without preservative, meaning there’s no alcohol or other solution in it to kill germs such as a fungus. So it’s very important that it be made under highly sterile conditions, experts said.
Compounding pharmacies aren’t as tightly regulated as drug company plants, but they are supposed to follow certain rules: Clean the floors and other surfaces daily; monitor air in “clean rooms" where drugs are made; require employees to wear gloves and gowns; test samples from each lot.
The rules are in the U.S. Pharmacopeia, a kind of national standards book for compounding medicines that’s written by a nonprofit scientific organization. Most inspections, though, are handled by state boards of pharmacy. Massachusetts last inspected New England Compounding in March in response to a complaint unrelated to the outbreak; the results have not been released.
High-volume production of the sort that went on at New England Compounding also raises the chances of contamination, experts said.
Traditionally, compounding pharmacies fill special orders placed by doctors for individual patients, turning out maybe five or six vials. But many medical practices and hospitals place large orders to have the medicines on hand for their patients. That’s allowed in at least 40 states but not under Massachusetts regulations.
Last month, New England Compounding recalled three lots of steroids made since May that totaled 17,676 single-dose vials of medicine — roughly equivalent to 20 gallons.
“I don’t see it as appropriate for a community pharmacy to do a batch of something preservative-free in Nnumbers in the thousands" of doses, said Lou Diorio, a New Jersey-based consultant to compounding pharmacies. Diorio, who has no connection to the investigation or the company, said it is harder to keep everything sterile when working with large amounts.
To make the steroid, a chemical powder from a supplier is mixed with a liquid, sterilized through heating, then pumped into vials, according to Eric Kastango, another consultant from New Jersey who helps compounding pharmacies deal with contamination problems. He is not connected to the company either.
Perhaps the powder was contaminated, either at New England Compounding or another location. Maybe the fungus was in the liquid, some experts said.
Kastango offered additional possible scenarios, related to the large volume produced: Making thousands of doses at a time can take many hours or days. It’s possible that a batch could sit for hours or even a day or so before being placed in vials, making it vulnerable to contamination, he said.

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