By Barbara Bronson Gray
THURSDAY, Oct. 11 (HealthDay News) -- Most Americans had probably never heard the term "compounding pharmacy" until the meningitis outbreak tied to contaminated steroid injections produced at a Massachusetts facility erupted last month.
Compounding is a time-honored practice in which pharmacists "combine, mix, or alter ingredients to create unique medications to meet specific needs of individual patients," according to the U.S. Food and Drug Administration.
The customized drugs are frequently required to accommodate special needs, such as a smaller dose, or the removal of an ingredient a patient is allergic to. Sometimes compounding pharmacies also produce drugs when FDA-approved manufacturers are unable to meet demand, as during drug shortages.
But over time, the practices of some compounding pharmacies -- traditionally community-based neighborhood druggists -- have expanded, often beyond their intended limits, experts explained.
In the last decade, firms with "pharmacy licenses making and distributing unapproved new drugs in a way that's clearly outside the bounds of traditional pharmacy" has become a worrisome trend, according to the FDA website.
"Consumers need to be aware that compounded drugs are not FDA-approved," said Kathleen Anderson, deputy director of the FDA's Division of New Drugs and Labeling Compliance in the Center for Drug Evaluation and Research. "This means that FDA has not verified their safety and effectiveness."
Steve Silverman, assistant director of the FDA's Center for Drug Evaluation and Research, added: "The methods of these companies seem far more consistent with those of drug manufacturers than with those of retail pharmacies. Some firms make large amounts of compounded drugs that are copies or near copies of FDA-approved, commercially available drugs. Other firms sell to physicians and patients with whom they have only a remote professional relationship."
On Wednesday, the governor of Massachusetts, Deval Patrick, said the compounding pharmacy at the center of the meningitis outbreak -- New England Compounding Center of Framingham -- may have deceived state officials and done work not authorized by its state license. The company was licensed to fill specific prescriptions for specific patients but exceeded that, he said, the Associated Press reported.
"What they were doing instead is making big batches and selling them out of state as a manufacturer would, and that is certainly outside of their state license," Patrick said.
A spokesman for the compounding center declined to respond to the governor's remarks, the AP said. The company has shut down operations and recalled its products.
Gary Dykstra, a professor at the University of Georgia College of Pharmacy who worked for the FDA for 40 years, said that while "pharmaceutical compounding started out with clear intentions, it has grown to be a very commercialized enterprise."
Why would physicians order routine medications from a compounding pharmacy rather than an FDA-approved manufacturer?
"It's a dollar-and-cents world out there and this particular compounding center was very adept at marketing their product at a good price," said Dykstra.
Dr. Neil Roth, an orthopedic surgeon at Lenox Hill Hospital in New York City, agreed that money is a big motivator. "It's cheaper," he said. "Buying from a compounding pharmacy gives a greater profit margin. People are doing this for cost effectiveness."
To date, 12 people have died and 137 have been sickened in the meningitis outbreak apparently linked to contaminated steroid injections produced by the New England Compounding Center.
Health authorities believe that all of the patients were injected with methylprednisolone acetate, a steroid drug routinely used to treat stubborn back pain. Investigators suspect the product was tainted with a fungus that's common in the environment and is often found in leaf mold, according to the U.S. Centers for Disease Control and Prevention.
As many as 13,000 people in 23 states may have gotten the shots, federal health officials said. The 13,000 figure includes not only people who got injections for back pain and are most at risk for meningitis, but also others who received injections for pain in their knees and shoulders. While nonsterile injections into the spine can make people susceptible to meningitis, the shots are likely to cause localized infections when injected into joints.