An outbreak of a rare disease called fungal meningitis continues to spread across the U.S. More than 90 patients have the illness, which is not contagious, and several people who contracted the disease have died.
The outbreak has been linked to an injectable steroid, made by a company called The New England Compounding Center, in Framingham, Mass. It is what's known as a “compounding pharmacy.”
Compounding pharmacies make medications -- ointments, tablets, and yes, injectable drugs, but they are not subject to the same regulations as drug manufacturers.
According to James Karboski, a clinical professor of pharmacy practice at the University of Texas at Austin’s College of Pharmacy, says the margins on prescription drugs today are thin.
Chain pharmacies make up for that, by selling more than medicine, but small pharmacies can’t do that as easily, so they have turned to compounding.
“With compounding, since they are individualized and unique, the provider has a lot more latitude to establish and specify the price,” David Kreling explains. He is the William S. Apple Distinguished Chair in Social/Administrative Sciences at the University of Wisconsin-Madison School of Pharmacy.
That price is often lower than what major drug-makers charge, which appeals to doctors and clinics.
Today, there are more than 7,500 compounding pharmacies in the U.S. Karboski says some of them are like “miniature manufactures.” But they are not technically manufacturers.
“The difference between compounding and manufacturing has always been a bit of a battle between the Food and Drug Administration and pharmacy organizations,” Karboski says.
Large-scale drug companies are regulated by the FDA, but compounding pharmacies are not. They are regulated at the state level.
Frank Palumbo heads the University of Maryland’s Center on Drugs and Public Policy. He says there is a lot we don’t know about compounding pharmacy linked to the meningitis outbreak, “but typically, a pharmacy is supposed to have a prescription for basically everything it dispenses to a patient.”
And Palumbo says it is hard to imagine the New England Compounding Center had a prescription for each of the steroids it shipped across the country -- more than 17,000 doses.