The recent outbreak of fungal meningitis, which has been linked with contaminated steroid injections, is the most serious such outbreak in US history. This problem has led to 14,000 exposures and almost 200 deaths. Unfortunately, this is not the first such outbreak America has seen as a result of using compounding pharmacies, and it is not likely to be the last.
Compounding pharmacies create customized medications for people who can’t take standard medications. They are used for a wide range of medications. Many cancer medications come from compounding pharmacies, as do flavored cold medications for young children. These pharmacies are popular with doctors and clinics because they don’t charge as much as traditional pharmacies do to provide medications.
Compounding pharmacies also are not as regulated as traditional pharmacies. They are more or less free to manufacture the drugs however they want as long as they follow state and federal laws. The FDA does not oversee how these pharmacies are run, although it steps in if there is a problem or if unsanitary conditions are reported. Thus, drugs made in these pharmacies may not be manufactured safely.
In the recent case, it’s not yet clear how the steroid injections became contaminated or whether NECC, the company that manufactured the drugs, followed all necessary safety precautions. Federal oversight may have helped correct any unsanitary practices before contamination occurred.
There have been other such incidents in the past; as recently as this past March, consumers expressed concern about compounding pharmacies after some patients were exposed to a fungus that caused eye infections. In 2011, nine people in Alabama died after receiving contaminated nutritional supplements. Incidents like this go all the way back to 2001, when consumer watchdogs first urged the FDA to tighten regulations and directly oversee compounding pharmacies. Since compounding pharmacies are responsible for a large number of drugs, failure to tighten regulations now may lead to an even worse outbreak of disease in the future.
This latest outbreak demonstrates the severity of the problem. Currently, 50 out of 17,000 potentially contaminated vials have tested positive for fungal meningitis; many more may turn out to be contaminated after testing is complete.