The ongoing outbreak of spinal infections -- with so far five patients dead and 30 with serious meningitis infections in six states, including Maryland and Virginia -- shows the antiquated regulatory system for drugs that are compounded by a pharmacy.
All the injected steroid drugs that have sickened and killed patients came from a pharmacy in Massachusetts that was "compounding" the drugs: in other words, mixing different drugs together and essentially manufacturing a new drug. The drugs were contaminated with a common fungus known as aspergillus. When injected into patients' spines for chronic pain, the patients got a fungal infection of the meninges, the lining of the spinal cord and brain.
The Food and Drug Administration closely regulates the manufacture of drugs by regular manufacturers. But the pharmacies that essentially manufacture drugs are in a regulatory shadowland. They are allowed to engage in the ancient art of "compounding" on the theory that they are making customized products for individual patients. But some have enough volume, like the pharmacy in Massachusetts that sold its contaminated injection drug across the entire eastern U.S., that they really should be treated as any other manufacturer.
The New York Times has a good story explaining this regulatory gap that endangers patients who unknowingly receive these compounded drugs.
The gatekeepers are the pain management doctors and pain clinics that order these drugs. I have spoken with pain management specialists who tell me they would never dream of buying drugs from any except an established manufacturer. But big clinics and hospitals can sometimes save money by buying from the compounding pharmacies. And patients never know what they're getting.
It's a scary proposition that needs new oversight from drug safety agencies. In the meantime, if you're a chronic pain patient who gets these injections, ask your doctor what source he is using.
Check our website for an article on other ways that patients can get infections in hospitals and clinics, which has links to prevention techniques.