Specialized, drug-producing pharmacies like the one implicated in the nation's ongoing meningitis outbreak have been tied to a string of fatal infections and overdoses stretching back more than a decade, a USA TODAY examination of public records shows.
The cases have prompted repeated calls since at least 2001 for better oversight of "compounding" pharmacies, which are not subject to the same stringent safety rules as large-scale drug manufacturers.
Despite those calls - from public health officials, patient advocates and pharmacists themselves - compounding pharmacies continue to operate in the seams of the regulatory system. They fall somewhere between the U.S. Food and Drug Administration (FDA), the federal regulator of the pharmaceutical industry, and the state boards of pharmacy that oversee more traditional druggists.
Thousands of these pharmacies play a critical role in providing custom drug mixtures and hard-to-find compounds that might otherwise be unavailable to doctors and their patients. But a proliferation of compounding operations in recent years and the growth of some into de facto manufacturing enterprises that produce and ship thousands of doses of medication all over the country have paved the way for serious problems.
Since 2001, records show that the FDA has issued more than 40 warning letters to compounding pharmacies for sanitary violations and failure to take proper steps to prevent the sale of dangerous or ineffective drugs.
"This has been a concern for the last 20 years and it's only going to get worse," says Eric Kastango, a pharmacist whose company, Clinical IQ, provides consulting services and training programs for improving quality at compounding pharmacies.
Demand for compounded drugs is growing, Kastango says, and more traditional pharmacies are compounding drugs as a profitable side business. In some cases, "their quality systems have been outstripped by the volume of compounding," he adds. "They're focusing less on quality and more on meeting demand and the profit associated with it."
Investigators are looking at whether the company suspected in the current meningitis outbreak, Framingham, Mass., based-New England Compounding Center (NECC), violated state and federal rules by manufacturing bulk quantities of drugs without underlying prescriptions, according to Dr. Madeleine Biondolillo, director of the Mass. Bureau of Health Care Safety and Quality, which regulates pharmacies.
FDA and the state are investigating whether contamination in an injectible steroid made by NECC is linked to meningitis cases that have killed 14 people and sickened 170 in 11 states.
In a statement, NECC said Saturday that it is cooperating with investigators and has recalled all products produced at the Framingham facility, but it noted that there is no conclusive evidence that its other drugs were contaminated.
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