Fungal meningitis cases spotlight risks from custom-mixed drugs
Recent fungal meningitis cases are part of a growing concern over contaminated custom-mixed drugs from 'compounding pharmacies' that supply hospitals, clinics, and doctors. The custom-mixed drugs are not FDA approved.
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"They fall into this gray area and no one supervises in a rigorous fashion their manufacturing processes. The state pharmacy boards don't have the resources or the knowledge or experience," and the FDA does not get involved unless a problem occurs, he said.Skip to next paragraph
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The FDA has said the steroid in the current meningitis outbreak came from the New England Compounding Center, based in Framingham, Mass. The company recalled three lots of the drug last week and has said it has voluntarily suspended operations and is working with regulators to identify the source of the problem. Investigators also are looking into the antiseptic and anesthetic used during the injections.
On Thursday, investigators urged doctors nationwide to avoid all products from the New England company. At least 23 states have received vials from the three recalled lots.
Compounding pharmacies are supposed to supply products to meet unique patient needs, and to prepare drug products that are not available commercially, based on an individual prescription. They may cross a line if they supply a product on a large scale to a clinic or hospital without individual prescriptions, Miller and other experts said.
"They, in effect, since they do this on a large scale, have become mini-pharmaceutical companies," Schaffner said.
That appears to be the basis for an FDA warning to the New England company and four other firms in December 2006. The FDA told them to stop compounding and distributing anesthetic creams "marketed for general distribution rather than responding to the unique medical needs of individual patients." Too much anesthetic in a rubbed-on cream can cause seizures and irregular heartbeats, and at least two deaths have resulted, the FDA said.
Miller, of the pharmacy trade group, said that in the current outbreak, it appears that the New England company was dispensing drugs widely to clinics and hospitals instead of filling individual prescriptions.
Some compounding pharmacies have had more than one troubling episode. And some products seem to have problems over and over again.
In May, officials reported 33 cases in seven states of a fungal eye infection stemming from products mixed in a Florida pharmacy that also prepared supplements that killed 21 elite polo horses in 2009.
The same steroid in the current outbreak was also tied to five cases of a different type of fungal infection in North Carolina in September 2002. Those patients also had shots from pain clinics, and one died.
Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP
Copyright 2012 The Associated Press.