Today’s Word on the Street: Compounding Pharmacies

With storm clouds possibly forming over Big Bird and his fellow Sesame Street friends these days, we thought we’d cheer them up with a little Muppet shout out, and this one goes to Murray Monster, host of that marvelously fun and enlightening segment called “Word of the Day.”  We have a new word for Murray today (actually, words): Compounding Pharmacy.  This is probably a new one for most PopTort fans.   It sure was new to us until we started reading about the causes for this nation’s massive, deadly meningitis outbreak caused by contaminated steroid shots produced at “the New England Compounding Center Inc in Framingham, Mass., … one of thousands of pharmacies that repackage or recombine medications on a sizable scale, sometimes for off-label use by thousands of patients.”  What's really surprising about “compounding pharmacies” is not just that they exist at all.  Turns out, they are completely unregulated by the Food & Drug Administration.  Writes Reuters, "The outbreak has alarmed health officials and highlighted a gap in regulation of so-called pharmacy compounders, which are facilities that take drug ingredients and package them into medications and dosages for specific clients. The federal Food and Drug Administration regulates only the ingredients and not the compounders, which are subject to a patchwork of state oversight."

Here's more:

Of the 56,000 or so free-standing U.S. pharmacies — the Walgreens and Duane Reades of America's Main Streets — more than half perform compounding, says the Houston-based International Academy of Compounding Pharmacists.… [But],

"Congress exempted drugs compounded by pharmacists from the usual safety and efficacy requirements," said Dr. Michael Carome of the Washington-based public advocacy group Public Citizen. "And now it's led to a public health disaster."

What’s the cost of this particular regulatory failure?  Here’s what we know so far:

US health officials said Monday that 13,000 patients in 23 states, including Connecticut, New Hampshire, and Rhode Island, have been injected with a potentially tainted steroid treatment made by a Framingham pharmacy and linked to a national outbreak of meningitis.

The US Centers for Disease Control and Prevention gave its sweeping estimate of the reach of the crisis as it reported 14 new cases of the disease, and another death in Tennessee, which appears to be the hardest hit among the states where the rare and serious form of fungal meningitis has been confirmed.

“We know that 13,000 people received the injection,” said Jamila Jones, a public affairs specialist for the CDC in Atlanta. “They received it at facilities across the country. They are at risk.”

So far, 105 cases and eight deaths have been confirmed nationally, the agency said.

There’s an effort now for new legislation finally to regulate these compounding pharmacies, which Reuters via Fox explains “operate in a legal limbo created by existing laws and federal court rulings that have effectively blocked the regulatory powers of the Food and Drug Administration, despite repeated threats to public health in the last decade." 

Democratic lawmakers said the new crisis showed it was time for Congress to strengthen the FDA's hand in overseeing this side of the drug industry. There was no immediate comment from Republican members of Congress, who tend to favor deregulation.

Pending legal cases may land the issue at the steps of the Supreme Court.…

"If regulation doesn't set a standard that seeks to prevent this, we can expect these outbreaks to keep happening," said Dr. John Santa, director of the Health Ratings Center at the Consumers Union advocacy group.

Words for tomorrow: Congress, do something!