Keep Our Families SafeBeware Pharmacy Compounding
Absinthe oil…fungus…New Zealand green-lipped mussel extract…
Not exactly the ingredients one would expect to find in their prescription medicine, are they? However, that may be precisely what is in some of your medicines thanks to a practice known as “pharmacy compounding.”
Pharmacy compounding is a small but growing practice among small-scale drug mixers who make prescription drugs from scratch. Pharmacists purchase bulk chemicals and then use their pharmacy laboratories to make these medications.
There might be some benefits to this practice but it can be illegal and dangerous. While it is via compounding that dye-free cough syrups are produced for patients allergic to the dyes found in commercial products, or antihistamine gummy bears for children unable to swallow pills. The practice of pharmacy compounding can be far more dangerous.
And what’s worse: it is practically unregulated by the U.S. Food and Drug Administration (FDA).
According to the FDA, compounded medications are technically illegal, but the agency is selective, at best, in it enforcement. Further, compounded products are not typically tested for safety or for purity before being sold, and the raw chemicals used by compounders often originate overseas and, in most cases, are not inspected by the FDA.
While the effects of this lax enforcement have already resulted in a handful of deaths, other consequences can be just as troubling.
In 2002, Eagles Springs, NC home inspector Donald Boles fell off a ladder and ruptured a disc. His doctor prescribed a spinal steroid injection to ease the pain. But after two more injections and back surgery the pain only got worse, not better.
It turned out that a rare fungus, normally found only in soil, was growing inside the soft tissues of Boles’s lower back. The fungus came from a batch of infected steroid shots that had been produced via compounding.
Filling the void left by the FDA have been state pharmacy boards. But they lack the resources to adequately police this rapidly growing industry.
Still, compounders have attracted enough attention to warrant some official action. The Justice Department is investigating more than 50 Southern Florida compounding pharmacies for Medicare fraud. The Drug Enforcement Agency is looking into compounders’ distribution of huge amounts of narcotic painkillers. Even the FDA is looking into compounders, and their suppliers, for selling ingredients that the FDA considers inappropriate for use.
Because this is still something of an emerging health issue, there are not a lot of sources of information and courses of action to take for concerned families. The FDA does offer some information about pharmacy compounding at http://www.fda.gov/cder/pharmcomp.